UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K/A
Amendment No. 1
(Mark One)
x
ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended April 30, 2015
or
o TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from __________ to __________
Commission file number 333-68008
PHARMACYTE BIOTECH, INC.
(Exact name of registrant as specified
in its charter)
Nevada |
62-1772151 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
12510 Prosperity Drive, Suite 310,
Silver Spring, MD 20904
(Address of principal executive offices)
(917) 595-2850
(Registrant’s telephone number, including area code)
Securities registered under Section 12(b) of the Act: |
None |
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Securities registered under Section 12(g) of the Act: |
None |
Indicate by check mark if the registrant is a well-known
seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No x
Indicate by check mark if the registrant is not required
to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No x
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes x No o
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T (§ 232.405) during the precedent 12 months (or for such shorter period that the registrant
was required to submit and post such files). Yes x No o
Indicate by check mark if disclosure of delinquent filers
pursuant to Item 405 of Regulation S-K (§ 229.405) is not contained herein, and will not be contained, to the best of registrant’s
knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment
to this Form 10-K. x
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated
filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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x |
Non-accelerated filer |
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o |
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Smaller reporting company |
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o |
(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell
company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x
State the aggregate market value of the voting and non-voting
common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average
bid and asked price of such common equity, as of October 31, 2014: $131,433,460.
As of July 28, 2015, the registrant had 742,610,829 outstanding
shares of common stock.
DOCUMENTS INCORPORATED BY REFERENCE
None.
Explanatory Note
We are filing this Amendment No. 1
on Form 10-K/A (“Amended Filing”) to our Annual Report on Form 10-K for the year ended April 30, 2015, which was filed
with the Securities and Exchange Commission (“Commission”) on July 29, 2015 (the “Original Filing”), to
amend and restate our audited consolidated financial statements and related disclosures as of and for the year ended April 30,
2015, as disclosed below in Note 1A to the accompanying restated consolidated financial statements and schedule and the consolidated
notes thereto (the “Restated Financial Statements”), as well as to amend certain other Items of the Original Filing
as set forth under the caption “Items Amended in this Filing” below, as a result of such amendment and restatement
of our consolidated financial statements.
Background of Restatement
As described below and in the notes
to the Restated Financial Statements, PharmaCyte Biotech, Inc. (including, where appropriate, its subsidiaries, “Company”)
restated its consolidated financial statements as of and for the year ended April 30, 2015 to reflect adjustments made to
correct the treatment of the issuance of certain shares of the Company’s common stock, $0.0001 par value per share (“common
stock”), warrants and certain other matters, as further described below, resulting in a material understatement to assets,
a material overstatement to liabilities and a material understatement to stockholders’ equity for the fourth quarter of
the year ended April 30, 2015, as well as corrections to disclosures relating to certain issuances of common stock and options
to purchase common stock to certain directors and officers of the Company. The nature and impact of these adjustments are
more particularly described below and in Note 1A to the Restated Financial Statements contained in this Amended Filing.
See also Note 16, Quarterly Financial Information (Unaudited), to the Restated Financial Statements, for the impact of
these adjustments to the fourth quarter of the year ended April 30, 2015.
The adjustments described above relate
to the Company’s issuance of certain warrants to purchase common stock with a cashless exercise feature (“cashless
warrants”) in connection with its entry into a marketing and consulting agreement (“Consultant Agreement”) with
a consultant on March 23, 2015. The Company accounted for the cashless warrants as a derivative liability in the Original
Filing. However, upon further analysis, the Company determined that the cashless warrants should have been accounted for as equity
in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). Additionally,
the Company determined that the Consultant Agreement, the issuance of shares of common stock to the consultant pursuant to the
Consultant Agreement and the issuance of certain warrants to purchase common stock with a cash exercise feature (“cash warrants”)
and the cashless warrants should have been recorded as a prepaid asset and amortized over the term of the Consultant Agreement
in accordance with U.S. GAAP in the Original Filing. In the Original Filing, the Company recorded a derivative liability of $492,049
on its consolidated balance sheets as of and for the year ended April 30, 2015. As a result of the Company’s determination
that the cashless warrants should be accounted for as equity, and that the Consultant Agreement, cash warrants and cashless warrants
should be accounted for as a prepaid asset, the Company decreased general and administrative expenses by the net amount of $434,754
on its consolidated statements of operations for the year ended April 30, 2015, and increased prepaid expenses and other assets
by the amount of $1,349,024, net of amortization, and decreased by the amount of $492,049 its total current liabilities on its
consolidated balance sheet as of April 30, 2015, as set forth in the Restated Financial Statements. As a result of these
adjustments, the Company also recorded a decrease to its accumulated deficit in the amount of $926,803, an increase to additional
paid in capital in the amount of $914,270 and an increase to total stockholders’ equity in the amount of $1,841,073.
As set forth in Note 1A and Note 9
to the Restated Financial Statements, the Company accounted for the expense of the cashless warrants for the year ended April
30, 2015 using the Black-Scholes option pricing model, which requires the exercise of significant judgment on the part of management
and estimates for the inputs used in the model. The following reflects the weighted-average assumptions used for purposes
of the model: risk-free interest rate of 1.41%; expected lives of the warrants of 5 years; expected volatility of 144%; no expected
dividend yield; and the number of warrants of 10,000,000.
The dividend yield assumption of zero
is based upon the fact the Company has never paid cash dividends and presently has no intention of paying cash dividends.
The risk-free interest rate used for each grant is equal to the U.S. Treasury rates in effect at the time of the grant for instruments
with a similar expected life. The expected lives are based on the remaining contractual lives of the related cashless warrants
at the valuation date. The Company’s computation of expected volatility is based on the historical daily volatility
of its publicly traded common stock.
As set forth in the Restated Financial
Statements, the effect of the timing of the recognition of the cashless warrant expense and the reclassification of the Consultant
Agreement, cash warrants and cashless warrants to prepaid assets resulted in a decrease of $926,803 to reported net loss.
In addition, as set forth in the Restated Financial Statements, the correction to the treatment of the cashless warrant expense
also resulted in an increase in consolidated other income in the net amount of $492,049 and an initial increase to consolidated
general and administrative expenses of $914,270, reduced by the reclassification of $1,349,024 to prepaid expense, for a net reduction
to consolidated general and administrative expenses in the amount of $434,754 in the Company’s consolidated statements of
operations for the year ended for the year ended April 30, 2015.
As set forth in the Restated Financial
Statements, with respect to the consolidated statement of cash flows for the year ended April 30, 2015, the adjustments described
above resulted in a decrease in net loss of $926,803, an increase in stock based compensation for warrants in the amount of $914,270,
a reduction in loss on derivative liability in the amount of $492,049 and an increase in current assets (prepaid expenses) in
the amount of $1,349,024.
Further, the Company also restated
two disclosures in Note 7, Common Stock Transactions, to the Company’s consolidated financial statements contained
in the Original Filing, as set forth in restated Note 7 to the Restated Financial Statements. The first disclosure correction
relates to the issuance of options to directors and officers to purchase 25 million shares of common stock during the year ended
April 30, 2015. The disclosure was restated to reflect that the current period non-cash compensation expense was $3,629,731 rather
than the $4,307,822 as reported in the consolidated statements of operations in the Original Filing. The second disclosure correction
relates to the issuance of 400,000 shares of common stock to two officers of the Company as compensation during the year ended
April 30, 2015 that was originally reported as an issuance of 600,000 shares. The disclosure was restated to reflect that the
current period non-cash expense was $87,200 rather than $133,440 as reported in the consolidated statements of operations in the
Original Filing and to remove the mention of the issuance of 2,400,000 shares of common stock issued to two officers that was
included in a separate disclosure.
Internal Control Considerations
In connection with the Restated Financial
Statements, our management has re-evaluated the effectiveness of our disclosure controls and procedures as of July 31, 2015 and
has concluded that our disclosure controls and procedures were not effective due to the material weaknesses in internal control
over financial reporting described in the Original Filing as well as the additional material weaknesses described below.
Management has also re-evaluated the
effectiveness of our internal control over financial reporting as of April 30, 2015. Based on such re-evaluation, management confirmed
that the material weaknesses in internal control over financial reporting described in the Original Filing continue to be material
weaknesses, and has identified additional material weaknesses in internal control over financial reporting relating to the accounting
for the Consultant Agreement, certain common stock issuances and warrants and certain disclosures relating to issuances of options
and common stock to directors and officers, which necessitated the restatement of our financial statements as of and for the year
ended April 30, 2015 and as of and for the periods ended July 31, 2015 and October 31, 2015, as described above and under the
caption “Restatement of Other Financial Statements” (collectively, “Restatements”).
For a discussion of management’s
consideration of our disclosure controls and procedures, internal control over financial reporting and the material weaknesses
identified, see Part II, Item 9A, “Controls and Procedures.”
Items Amended in This Filing
This Amended Filing sets forth the
Original Filing, as modified and superseded where necessary to reflect the restatement described above. The following Items have
been amended and restated as a result of, and to reflect, the Restated Financial Statements:
Part I –
Item 1A. Risk Factors;
Part II –
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations;
Part II –
Item 8. Financial Statements and Supplemental Data;
Part II –
Item 9A. Controls and Procedures; and
Part IV –
Item 15. Exhibits, Financial Statement Schedules.
Except as set forth above, no other
information included in the Original Filing has been amended or updated by this Amended Filing. This Amended Filing continues
to describe the conditions as of the date of the Original Filing and, except as contained herein, we have not updated or modified
the disclosures contained in the Original Filing. Accordingly, this Amended Filing should be read in conjunction with our filings
made with the Commission subsequent to the filing of the Original Filing, including any amendments to those filings.
Restatement of Other Financial Statements
Along with the filing of this Amended
Filing, we are concurrently filing amendments to our Quarterly Reports on Form 10-Q for the quarters ended July 31, 2015 and October
31, 2015. The amendments to our Quarterly Reports on Form 10-Q are being filed to restate our unaudited condensed consolidated
financial statements and schedules and related notes and disclosures for the periods covered by those reports. The amendments
to the two Quarterly Reports on Form 10-Q are attributable to the effect of the Restated Financial Statements as described above
under the caption “Background of Restatement.” For further information, see our amended filings on Form 10-Q/A for
the periods ended July 31, 2015 and October 31, 2015.
Forward-Looking Statements
This Amended Filing (“Report”)
includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended
(“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”).
All statements other than statements of historical fact are “forward-looking statements” for purposes of this Report,
including any projections of earnings, revenue or other financial items, any statements regarding the plans and objectives of
management for future operations, any statements concerning proposed new products or services, any statements regarding future
economic conditions or performance, any statements regarding expected benefits from any transactions and any statements of assumptions
underlying any of the foregoing. In some cases, forward-looking statements can be identified by the use of terminology such as
“may,” “will,” “expects,” “plans,” “anticipates,” “estimates,”
“potential” or “continue,” or the negative thereof or other comparable terminology. Although we believe
that the expectations reflected in the forward-looking statements contained in this Report are reasonable, there can be no assurance
that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially
from those projected or assumed in the forward-looking statements. Thus, investors should refer to and carefully review information
in future documents we file with the Securities and Exchange Commission (“Commission”). Our future financial condition
and results of operations, as well as any forward-looking statements, are subject to inherent risk and uncertainties, including,
but not limited to, the risk factors set forth in “Part I, Item 1A – Risk Factors” below and for the reasons
described elsewhere in this Report. All forward looking statements and reasons why results may differ included in this Report
are made as of the date hereof, and we do not intend to update any forward-looking statements except as required by law or applicable
regulations. Except where the context otherwise requires, in this Report, the “Company,” “PharmaCyte Biotech,”
“we,” “us” and “our” refer to PharmaCyte Biotech, Inc., a Nevada corporation, and, where appropriate,
its subsidiaries.
PART I
ITEM 1. BUSINESS.
Overview
We are a clinical stage biotechnology
company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based
live cell encapsulation technology known as “Cell-in-a-Box®” This unique and patented technology will
be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer, and
diabetes are being developed.
Our treatment for pancreatic cancer
involves encapsulating modified live cells capable of converting the prodrug ifosfamide into its active or “cancer-killing”
form. These encapsulated live cells are placed as close to the tumor as possible to enable the delivery of the highest levels of
the cancer-killing drug at the source of the cancer. Ifosfamide is then given intravenously at one third the normal dose to eliminate
adverse side effects. When the ifosfamide comes in contact with the encapsulated live cells through the circulatory system, the
activation of the drug takes place at or near the tumor. This “targeted chemotherapy” has proven remarkably effective
and safe to use in past clinical trials. Using the same technology, we are working on improving the quality of life for patients
with advanced pancreatic cancer and on treatments for other types of cancerous solid tumors.
We are also developing treatments for
cancer based upon chemical constituents of the Cannabis plant, known as “cannabinoids.” We are examining ways
to exploit the benefits of Cell-in-a-Box® technology in optimizing the anticancer effectiveness of cannabinoids,
while minimizing or outright eliminating the debilitating side effects usually associated with chemotherapy. This provides us with
the opportunity to develop “green” approaches to fighting deadly diseases, such as cancer of the pancreas, brain and
breast, which affect hundreds of thousands of individuals worldwide every year.
In addition to developing treatments
for pancreatic and other solid tumor cancers, we are developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes.
We plan to encapsulate a human cell line which has been genetically engineered to produce, store and secrete insulin at levels
in proportion to the levels of blood sugar in the human body. The encapsulation will be done using our Cell-in-a-Box®
technology.
Cancer Treatment
The Cell-in-a-Box® encapsulation
of genetically modified live cells capable of converting the anticancer prodrug (a prodrug requires conversion or “activation”
for it to be effective) ifosfamide into its cancer-killing form will be performed at Austrianova’s manufacturing facility
in Bangkok, Thailand. These facilities will adhere to international current Good Manufacturing Practices (“cGMP”) standards.
We have entered into a Master Services
Agreement with ViruSure GmbH (“ViruSure”) in Vienna, Austria, pursuant to which ViruSure will clone cells from the
22P1G cell line (the cells that express the CYP2B1 isoform of cytochrome P450 that converts ifosfamide into its cancer-killing
form). ViruSure will then develop a Master Cell Bank (“MCB”) and, from that, a Working Cell Bank (“WCB”).
The MCB is to be used as a “safe” repository of the selected clone cells. The WCB will be used to supply the large
numbers of cells needed for our preclinical studies, clinical trials and other purposes related to the development of our treatment
for advanced pancreatic and other forms of solid tumor cancers. Compensation to ViruSure is set forth in separate agreements, and
the price, fees and payment schedule depends upon the particular work being undertaken by ViruSure on our behalf.
The principal developers of the Cell-in-a-Box®
cellulose-based live cell encapsulation technology are Dr. Walter H. Günzburg and Dr. Brian Salmons. Both are officers
of SG Austria Pte Ltd (“SG Austria”) and its wholly-owned subsidiary, Austrianova Singapore Pte Ltd (“Austrianova”).
We own a 14.5% equity interest in SG Austria and have contractual relationships with Austrianova. The success of SG Austria and
Austrianova are co-dependent in almost every respect with our success. SG Austria and Austrianova benefit from our success. As
we reach certain “milestones” in the progression of its live cell encapsulation technology towards the development
of treatments for cancer and diabetes, payments will be made by us to SG Austria or Austrianova. The future royalty and milestone
payments are as follows: (i) two percent royalty on all gross sales; (ii) ten percent royalty on gross revenues from sublicensing;
(iii) milestone payments of $100,000 after enrollment of the first human patient in the first clinical trial for each product;
(iv) $300,000 after the enrollment of the first human patient in the first Phase 3 clinical trial; and (v) $800,000 after obtaining
marketing authorization Regulatory Agencies. Milestone payments of $50,000 are to be made after the enrollment of the first veterinary
patient for each veterinary product and $300,000 after obtaining marketing authorization for each veterinary product. These milestone
payments are described in more detail below.
Dr. Günzburg and Dr. Salmons are
involved in all aspects of the scientific endeavors underway and being planned by us, having commenced work for us as consultants
at the beginning of 2014 under an oral agreement. They currently provide their services as consultants through their consulting
company, Vin-de-Bona Trading Company Pte Ltd (“Vin-de-Bona”). This arrangement was formalized as of April 1, 2014,
with the execution of a Consulting Agreement between us and Vin-de-Bona. The Consulting Agreement has an initial term of 12 months,
with additional terms of 12 months automatically renewing unless either party terminates an additional term upon 30 days’
prior written notice. The professional services rendered to us by Dr. Günzburg and Dr. Salmons are charged at a negotiated
and confidential hourly rate.
The Consulting Agreement requires that
Dr. Günzburg and Dr. Salmons not disclose or use our confidential information for any purpose, other than performing services
under the Consulting Agreement, without our prior written consent. In addition, during the term of the Consulting Agreement and
for a period of twelve months after termination or expiration of the Consulting Agreement, Dr. Günzburg and Dr. Salmons are
prohibited from soliciting any of our customers, employees, suppliers or other persons with whom they had dealings during the tenure
of their consultancy with us.
Commencing September 30, 2014, Dr. Günzburg
was appointed as our Chief Scientific Officer. On December 22, 2014, Dr. Günzburg was compensated by paying Vin-de-Bona 500,000
shares of our common stock. The shares were valued at the date of issuance and resulting in a non-cash expense of $98,500. He will
be compensated in the same way and amount for each succeeding year during which he serves as our Chief Scientific Officer.
Dr. Günzburg and Dr. Salmons are
involved in our Phase 2b clinical trial in pancreatic cancer that will be conducted in Australia by one of the foremost Contract
Research Organizations (“CRO”) in that country, Clinical Network Services Pty Ltd (“CNS”). This Phase 2b
clinical trial will compare our treatment for advanced pancreatic cancer “head to head” with the best available therapy.
That therapy is currently Celgene’s drug Abraxane® in combination with gemcitabine to treat advanced, inoperable
pancreatic cancer.
Dr. Matthias Löhr, a renowned European
oncologist and gastroenterologist, will also play a major role in the development of our pancreatic cancer treatment. Dr. Löhr,
currently with the Karolinska Institute in Stockholm, Sweden, served as Principal Investigator of the earlier Phase 1/2 and Phase
2 clinical trials of the combination of CapCell® (now known as Cell-in-a-Box®) with low-dose ifosfamide
in patients with advanced, inoperable pancreatic cancer. Dr. Löhr is extremely familiar with the use of this combination
treatment in a clinical setting. Like Dr. Günzburg and Dr. Salmons, Dr. Löhr is involved in planning much of the Phase
2b clinical trial. Dr. Löhr will also oversee how the clinical trial is conducted.
Preparations necessary for the Phase
2b clinical trial are well underway. We plan to commence the Phase 2b clinical trial the latter part of this year.
The efforts of Dr. Günzburg, Dr.
Salmons and Dr. Löhr also include work associated with the preclinical studies and clinical trials we plan to conduct in the
United States in the latter part of this year as well. Translational Drug Development (“TD2”), one of the leading CROs
in the United States specializing in oncology, is handling the preclinical studies and clinical trials. These studies and trials
involve determining the effectiveness of our pancreatic cancer treatment in: (i) ameliorating the virtually untreatable and unbearable
pain associated with advanced pancreatic cancer that occurs in 20-25% of patients; and (ii) the effects of the treatment on the
rate of accumulation of fluid in the abdomen, known as “malignant ascites” (malignant ascites occurs in patients with
pancreatic and other solid abdominal tumors and contains cancer cells that can “seed” and form new tumors in the body).
Work is underway planning for these
clinical trials. We anticipate these trials will also commence in this latter part of this year.
Cannabis to Treat Diseases
With 23 states and the District of Columbia
approving the use of marijuana, commonly referred to in the scientific community as “Cannabis” for medicinal
purposes, a plethora of medical marijuana companies have emerged. Most of these involve the production and distribution of Cannabis
in its various forms, such as liquid extracts and pills, as well as Cannabis delivery systems - such as vapor pens. Very
few are focused on using constituents of Cannabis for the treatment of specific diseases. We are.
Our major competitors for the development
of Cannabis-based treatments for cancer are Cannabis Science, Inc. (“CSI”) and GW Pharmaceuticals, Plc. (“GWP”).
CSI plans to use complex extracts of Cannabis to develop treatments for basal and squamous cell (skin) carcinomas and Kaposi’s
sarcoma. GWP is developing a product portfolio of cannabinoid-based prescription medicines.
In contrast to the work being done by
these companies, we plan to develop treatments for two of the deadliest forms of cancer - brain and the pancreatic - rather than
Kaposi’s sarcoma and skin cancer. We also plan to focus initially on developing specific treatments based on carefully chosen
molecules rather than using complex Cannabis extracts. Targeted cannabinoid-based chemotherapy utilizing our Cell-in-a-Box®
technology offers a “green” approach to treating solid-tumor malignancies. Cannabis has provided a sustainable
source of fiber, food, energy and medicine for thousands of years. The plant’s constituents, such as ∆9-tetrahdyrocannabinol
and cannabidiol, have been well-documented to have broad anti-inflammatory, antioxidant, analgesic and nerve protecting abilities.
But they also inhibit or prevent the growth and spread of tumors or malignant cells. An understanding
of the chemical and biochemical processes involved in the interaction of substances derived from Cannabis with live cell
encapsulation provides the opportunity to develop “green” approaches to treating cancers, such as pancreatic, brain,
breast and prostate, among others. We believe we are in a unique position among medical marijuana and pharmaceutical companies
to develop cannabinoid-based therapies utilizing our proprietary live cell encapsulation technology as the platform.
We have entered into a Research Agreement
with the State of Colorado, acting on behalf of the Board of Trustees of the University of Northern Colorado. The goal of the ongoing
research is to develop methods for the identification, separation and quantification of constitutes of Cannabis (which are
prodrugs) that may be used in combination with our Cell-in-a-Box® technology to treat diseases. Initial studies
have been undertaken using non-cannabinoid model compounds to identify the appropriate cell type that can convert the selected
cannabinoid prodrugs into metabolites with antineoplastic activity. Once identified, the genetically modified cells that will produce
the appropriate enzyme to convert that prodrug will be encapsulated using our Cell-in-a-Box® technology. The encapsulated
cells and cannabinoid prodrugs identified by these studies will then be combined and used for future studies to evaluate their
antineoplastic effectiveness.
Diabetes Treatment
Diabetes is a major health problem throughout
the world. It is estimated that 387 million people worldwide have the disease and that by 2035 the number will have risen to more
than 592 million. Diabetes caused 4.9 million deaths in 2014. Every seven seconds a person dies from the complications caused by
diabetes. In the U.S. alone, diabetes caused $612 billion in health care expenditures in 2014. The worldwide market for diabetes
treatments alone has been projected to reach $650 billion by 2020.
Diabetes is caused by insufficient availability
or resistance to insulin. Insulin is produced by the islet cells of the pancreas. Its function is to assist in the transport of
sugar in the blood to the inside of most types of cells in the body where it is used as a source of energy for those cells. In
Type 1 diabetes, the islet cells of the pancreas have been destroyed - usually by an autoimmune reaction. Type 1 diabetics require
daily insulin administration through injection or through the use of an insulin pump. Type 2 diabetes can be controlled by diet
and exercise in its early stages. As time goes by, it may be necessary to use antidiabetic drugs to control the diabetes. However,
over time these too may lose their effectiveness. Thus, even Type 2 diabetics may become insulin-dependent.
In an effort to “cure” Type
1 diabetes, replacement of damaged pancreatic beta islet cells has been attempted. This involves transplantation of the entire
pancreas or of its beta islet insulin-producing cells. Such studies began in the late 1960s, but success was limited until 2000.
That is when islet cells from human cadavers were transplanted into insulin-dependent diabetics in a clinical trial. Control of
blood sugar levels was achieved. In this clinical trial, all 7 patients enrolled in the clinical trial remained insulin-independent
for one year. But because of the high doses of immune-suppressive drugs that must accompany such transplantations, patients were
placed at high risk of infection by opportunistic organisms and even of developing cancerous growths. These drugs have serious
side effects and have required patients to cease treatment with them. Worldwide, less than 1,000 people with Type 1 diabetes have
been transplanted with pancreatic islets from another human.
In an effort to avoid the use of islet
cells from human donors, encapsulated islet cells from pigs have been used. This type of interspecies transplantation is known
as xenotransplantation. Drug regulatory authorities have been resistant to approving the use of such interspecies transplantations.
However, there are problems besides regulatory approval.
An attack by the body’s immune
system is the first and foremost problem. To protect the transplanted non-human islet cells from attack by the host’s immune
system, these cells have been encapsulated using other forms of encapsulation technology than we use. In those studies, the transplanted
islet cells from pigs were surrounded by a porous capsule, typically made of alginate (a derivative of seaweed), which allows them
to survive and exchange small molecules such as glucose and insulin with their environment. These encapsulation efforts were used
in an attempt to shield the transplanted islet cells from destructive attack by cells of the body’s immune system.
Efforts to translate this concept into
a viable treatment for Type 1 diabetes have been plagued by poor survival of the transplanted islet cells due to sub-optimal oxygen
supply for the islet cells and attack on the cells by pro-inflammatory substances, such as cytokines. In addition, the integrity
of capsules composed of alginate has been shown to degrade over time. This then allows for immune system attack on the transplanted
pig islets and necessitates additional transplantations. Moreover, as the alginate “capsules” degrade, they can elicit
an immune response.
Different tubular and planar “chamber-type”
immune-protective devices that contain islet cells are under development. Such devices are placed where they can be retrieved and
replaced when necessary. Tubular chambers have shown good biocompatibility, but they are subject to rupture, exposing the islets
to immune system attack. They also require large numbers of islets cells. Planar chambers are more stable, but they can cause extensive
foreign body reactions resulting in fibrotic overgrowth and thus transplant failure.
The most extensively researched immune-protective
strategy is that which employs micro-capsules. Micro-capsules are mechanically stable and have a favorable surface to volume ratio,
which results in good diffusion characteristics. They are relatively simple to manufacture, can be implanted into the body without
major surgery and, depending on the nature of the encapsulation material, micro-encapsulated cells can be cryopreserved.
Micro-encapsulated islet cells first
made their appearance in 1994 when a diabetic patient, already receiving immunosuppressive drugs, was transplanted with these cells
encapsulated in alginate and remained insulin-independent for 9 months. However, after 18 years and numerous clinical trials later,
there are still no reports of long-term insulin-independence in non-immune-suppressed diabetic patients receiving encapsulated
pancreatic islet transplants. Clinical trials by different groups showed similar outcomes. The clinical benefit for the patients
was modest because, soon after transplantation, insulin administration had to be resumed.
We plan to develop a treatment for Type
1 diabetes that is unique among available treatments for this disease. This treatment will also be available for those who need
it and who have Type 2 diabetes where traditional diabetes medications are no longer effective. We are developing a treatment that
involves encapsulation of a human cell line genetically engineered to produce, store insulin and secrete insulin on demand at levels
in proportion to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box®
technology.
We have obtained from the University
of Technology Sydney (“UTS”) in Australia the worldwide license to use a line of insulin-producing genetically modified
cells developed by Prof. Ann Simpson and her colleagues at UTS for the development of a treatment for insulin-dependent diabetes
(“Melligen Cell License Agreement”). These cells, named “Melligen,” have already been tested and shown
to produce insulin in direct proportion to the amount of glucose in their surroundings. In fact, when Melligen cells were transplanted
into diabetic mice whose immune systems were essentially not functioning, the blood glucose levels of the mice became normal. This
observation illustrates that Melligen cells can reverse the diabetic condition. Our partner, Austrianova, has already successfully
encapsulated Melligen cells using the Cell-in-a-Box® technology.
Melligen cells can be readily grown
in culture and hence are available in unlimited supply. Compared to native pancreatic beta islet cells, Melligen cells are much
more resistant to the pro-inflammatory cytokines that have been shown to be involved in beta islet cell death. This property makes
them the ideal candidate cell line for beta islet cell replacement therapy with the prospect to achieve long-term transplant graft
function.
Encapsulating the Melligen cells using
Cell-in-a-Box® technology has numerous advantages over encapsulation of cells with other materials, such as alginate.
Since they are composed largely of cellulose (a bio-inert material in the human body), the Cell-in-a-Box® capsules
are exceedingly robust. This allows them to remain intact for long periods of time in the body, all the while protecting the cells
inside them from immune system attack. Furthermore, these capsules and the cells inside them do not give rise to any immune or
inflammatory responses like those seen with alginate-encapsulated cells. Recently, a scientific review article discussed the advantages
of the Cell-in-a-Box® encapsulation technology over alginate-based encapsulation for use in the development of a
treatment for insulin-dependent diabetes.
We believe that the combination of the
Melligen cells and the Cell-in-a-Box® encapsulation technology could lead to a break-through treatment for insulin-dependent
diabetes using these genetically modified insulin-producing cells that will overcome all of the past problems in developing a true
bio-artificial pancreas.
We have established an international
Diabetes Consortium that consists of world-renowned physicians and scientists from several countries, all of whom share the same
goal of developing a treatment for insulin-dependent diabetes. We have research agreements in place with the University of Veterinary
Medicine Vienna (“UVMV”) in Vienna, Austria, UTS in Sydney, Australia, the Vorarlberg Institute for Vascular Investigation
and Treatment (“VIVIT”) in Feldkirch, Austria, the University of Barcelona (“UOB”) in Barcelona, Spain
and the University of Copenhagen (“UOC”) in Denmark. A research agreement is in the process of being finalized with
the Ludwig-Maximillian University (“LMU”) in Munich, Germany.
In addition to our Chief Executive Officer
and Chief Operating Officer, the Diabetes Consortium is made up of well-known scientists from the universities and institutions
identified above and from the Karolinska Institute in Stockholm, Sweden, and the biotech company Austrianova in Singapore.
Dr. Eva Maria Brandtner leads the Diabetes
Consortium and is our Director of Diabetes Program Development. Dr. Brandtner, who is also a consultant for us, previously served
as the Chief Scientist with Austrianova. In that role, she conducted preclinical studies with the Melligen cells. As
mentioned above, Prof. Simpson and her colleagues at UTS developed the Melligen cell line. Prof. Simpson is also a member
of the Diabetes Consortium and serves as a consultant under a Consulting Agreement with UTS.
In addition to our key personnel, Dr.
Brandtner and Prof. Simpson, the Diabetes Consortium includes Dr. Gunzburg, our Chief Scientific Officer and the Chief Technical
Officer of Austrianova, and Dr. Salmons, the Chief Executive Officer of Austrianova and a member of our Scientific Advisory Board. It
also includes Dr. Constantine Konstantoulas from UVMV who coordinates the daily activities of the Diabetes Consortium and works
on many of the preclinical studies being done to develop our treatment for insulin-dependent diabetes. The research scientists,
Prof. Dr. Eckhard Wolf and Prof. Dr. Rüdiger Wanke from LMU, are also key members of the Diabetes Consortium. These professors,
together with their colleagues at LMU, have developed unique animal models for insulin-dependent diabetes. The other key members
of the Diabetes Consortium include Prof. Dr. Thomas Stratmann of the UOB and Prof. Dr. Axel Kornerup Hanson of UOC.
Finally, Dr. Löhr is playing a
major role in the development our diabetes program. Because he is an expert in diseases of the pancreas, Dr. Löhr is an expert
in both pancreatic cancer and diabetes and has already had extensive experience in the clinic using the Cell-in-a-Box®
technology, having served as Principal Investigator for the early-phase clinical trials pancreatic cancer that involved the combination
of that technology and the cancer prodrug ifosfamide.
Our Business
We operate independently and through
four wholly-owned subsidiaries: (i) Bio Blue Bird AG (“Bio Blue Bird”); (ii) Nuvilex Europe Limited (soon to be renamed
PharmaCyte Biotech Europe Limited); (iii) Nuvilex Australia Limited (soon to be renamed PharmaCyte Biotech Australia Private Limited);
and (iv) Viridis Biotech, Inc. (“Viridis Biotech”).
In 2013, we restructured our operations
in an effort to focus on biotechnology, having been primarily a nutraceutical products company in the recent past. The restructuring
resulted in us focusing all of our efforts on the Cell-in-a-Box® technology for the development of unique, effective
and safe ways to treat cancer and diabetes.
Effective June 25, 2013, we entered
into a Third Addendum (“Third Addendum”) to an Asset Purchase Agreement with SG Austria previously entered into dated
July 26 2011 (“SG Austria APA”). The Third Addendum resulted in us acquiring 100% of the equity interests in a subsidiary
of SG Austria, Bio Blue Bird, and receiving a 14.5% equity interest in SG Austria.
Our acquisition of a 14.5% equity interest
in SG Austria and a 100% interest in Bio Blue Bird were the first acquisitions related to our biotechnology company. The acquisition
of Bio Blue Bird provided us with exclusive, worldwide licenses to use the Cell-in-a-Box® technology for the development
of treatments for all forms of cancer using certain types of cells. The licenses are pursuant to patents licensed from Bavarian
Nordic A/S and GSF-Forschungszentrum fur Umwelt u. Gesundheit GmbH. They enable us to carry out the research and development of
cancer treatments using the Cell-in-a-Box® technology.
In July 2013, we acquired from Austrianova
the exclusive, worldwide license to use the Cell-in-a-Box® technology for the development of a treatment for diabetes
and the use of Austrianova’s “Cell-in-a-Box®” trademark for this technology (“Diabetes Licensing
Agreement”). We made our first $1,000,000 payment to secure the Diabetes Licensing Agreement on October 30, 2013. The second
and final payment of $1,000,000 was made on February 25, 2014.
In December 2014, we also acquired from
Austrianova the exclusive, worldwide license to use the Cell-in-a-Box® technology in combination with compounds
from constituents of Cannabis for development of disease treatments and the use of Austrianova’s “Cell-in-a-Box®
trademark for this technology (“Cannabis Licensing Agreement”). As a result of the Cannabis Licensing Agreement,
we are developing treatments for cancer using the chemical constituents of the Cannabis plant in combination with the Cell-in-a-Box®
technology. As of April 30, 2015, we paid Austrianova $1.0 million of the $2.0 million “Upfront Payment” required by
us to be made by for this license. As of the date of this Report, we have paid $1.3 million of the Upfront Payment. The parties
have agreed to an amendment to the Cannabis Licensing Agreement pursuant to which the balance of the Upfront Payment will be due
by December 31, 2015. That amendment is in the process of being documented.
Management Goal and Strategy
Our goal is to become an industry-leading
biotechnology company using the Cell-in-a-Box® live cell encapsulation technology as a platform upon which treatments
for cancer and diabetes can be developed.
Our initial strategy is to build upon and advance
the success of the previous Phase 1/2 and Phase 2 pancreatic cancer clinical trials. Our acquisition of Bio Blue Bird was the first
step in this strategy. This acquisition enabled us to advance as a biotechnology company. We believe we are positioned to move
forward and become a significant biotech company predicated upon the Cell-in-a-Box® technology.
We will seek to raise capital to fund growth
opportunities and provide for our working capital needs as our strategy is executed. Our strategy to achieve financial stability
and to enable us to reach our goal consists of the following:
| · | The completion of the preparations for the Phase 2b clinical trial in advanced, inoperable pancreatic
cancer to be conducted by CNS in Australia; |
| · | The completion of the preparations for the clinical trials that will examine the effectiveness
of our pancreatic cancer treatment in ameliorating the pain and accumulation of malignant ascites fluid in the abdomen that are
characteristic of pancreatic cancer. These clinical trials will be conducted by TD2 in the United States; |
| · | The completion of preclinical studies that involve the encapsulation of a human cell line genetically
engineered to produce, store and secrete insulin on demand at levels in proportion to the levels of blood sugar in the human body.
The encapsulation will be done using the Cell-in-a-Box® technology; |
| · | The enhancement of our ability to expand into the biotechnology arena through further research
and partnering agreements; |
| · | The acquisition of new contracts that generate revenue or provide research and development capital
utilizing our sublicensing rights; |
| · | The further development of uses of the Cell-in-a-Box® technology platform through
contracts, licensing agreements and joint ventures with other companies; and |
| · | The completion of testing, expansion and marketing of existing and newly derived product candidates. |
Cell Therapy Product Development
In our effort to bring potential treatments
to bear on pancreatic and other solid tumor cancers, we acquired Bio Blue Bird. This subsidiary holds exclusive worldwide licenses
to our unique cellulose-based live cell encapsulation technology for use in oncology with certain types of live cells. The capsules
are comprised of cotton’s natural component - bio-inert cellulose. Other materials used by competitors include alginate,
collagen, chitosan, gelatin and agarose. Cellulose appears to be the most robust of these. This inherent strength provides the
Cell-in-a-Box® capsules with advantages over the competition. For example, the Cell-in-a-Box® capsules
have remained intact for more than two years in humans and for several months in animals during preclinical studies and clinical
trials with no evidence of rupture, damage, degradation, fibrous overgrowth or an immune system response. In addition, the cells
within the capsules remained alive and well during the course of the studies and trials. Other encapsulating materials degrade
over time in the human body, leaving the encapsulated cells open to immune system attack. Damage to surrounding tissues has also
been reported to occur over time when other types of encapsulation materials degrade in the body.
We intend to use our cellulose-based
live cell encapsulation technology for creating treatments for patients suffering from cancers and insulin-dependent diabetes.
Initially, focus will be placed on the preparations for a Phase 2b clinical trial in advanced pancreatic cancer. These preparations
will include the live cell encapsulation of cancer prodrug-activating cells. For the Phase 2b clinical trial, as in the earlier
Phase 1/2 and Phase 2 clinical trials, cells expressing a cytochrome P450 isozyme (“CYP2B1”) for use in cancer therapy
will be utilized. These cells were used in the earlier clinical trials in patients with advanced, inoperable pancreatic cancer.
These cells were genetically modified so that they could convert the cancer prodrug ifosfamide into its active cancer-killing form.
When the encapsulated cells were placed in close proximity to the cancerous tumor in the pancreas and then one-third of normal
dose of the anticancer prodrug ifosfamide was given intravenously, the passage of the ifosfamide through the capsules created an
elevated local concentration of an active chemotherapy drug capable of stopping the growth of or killing the cancer cells. The
results of this “targeted chemotherapy” are discussed in more detail below.
The Cell-in-a-Box® encapsulation
technology enables living cells to be used as miniature factories. The technology results in the formation of pin-head sized cellulose-based
capsules in which genetically modified cells can be encapsulated and maintained. In the laboratory setting, which involves the
large scale amplification and production of useful biotech products outside the body of a person or animal, the proprietary live
cell encapsulation technology creates a micro-environment in which these cells survive and flourish. They are protected from environmental
challenges, such as the sheer forces associated with bioreactors, enabling greater growth and production of the end product.
The aim is for production of genetically
modified encapsulated cells that are capable of being placed inside the body of a person or an animal in precisely the right location
to target the disease being treated. The Cell-in-a-Box® encapsulation technology enables cells to survive
in the human host and function like any other living cell in the body. Since the capsules produced using this technology contain
small pores, small molecules (such as nutrients, oxygen and waste products) can pass through the pores of the capsules whereas
the encapsulated cells and cells of the immune system cannot, thus enabling the encapsulated therapeutic cells to ‘live’
in the body, thereby behaving like new miniature organs of the body without any inflammatory response or rejection.
The two areas we are currently developing
for live cell encapsulation-based treatments are cancer and diabetes. The field of diabetes cell therapy development is competitive.
There are a number of companies developing cell based therapies for diabetes. These competitors include Living Cell Technologies,
Viacyte, Cellmed, Microislet Sciences, Cerco Medical and BetaCell, among others. Although competition exists, we believe these
other companies are developing encapsulation-based treatments using encapsulation materials and methodologies to produce capsules
or devices that are far less robust than ours or that are associated with other problems that are not characteristic of our Cell-in-a-Box
capsules.
We believe our live cell encapsulation
technology brings significant new advantages and opportunities to market for us in numerous and developing ways. For example:
| · | The treatment of diseases by placing encapsulated drug-converting cells that convert the active
agent near the diseased tissue or organ; |
| · | The confinement and maintenance of therapeutic cells at the site of implantation at or near cancerous
tumors ensuring “targeted chemotherapy;” |
| · | The increased efficacy of chemotherapeutic drugs allowing for lower dosages and thus reduced side
effects; |
| · | The potential for the treatment of systemic diseases of numerous types, including diabetes; |
| · | The provision of a safety mechanism for regulating cells that are introduced that would be desired
to be maintained at specific sites in the body as a part of therapy; |
| · | The multi-layered patent and trade secret protection and marketing exclusivity for the technology
that is being expanded; |
| · | The capsules that prevent immune system attack of functional cells without immunosuppressive drug
therapy; and |
| · | The safety of the technology and the cells used that has already been shown in both human and animal
clinical trials. |
Market Opportunity and the Competitive Landscape
Estimates indicate that in approximately 25%
of pancreatic cancer patients, the cancer is too advanced for any treatment due to late diagnosis and resulting short survival
times. The disease is typically operable in approximately only 10% of patients after being diagnosed. Therefore, we believe the
potential market for our product equates to approximately 68% of the incidence in industrialized countries or about 338,000 new
patients per year in 2012. Due to the “unmet medical need” status of pancreatic cancer, the biotechnology and pharmaceutical
sectors have been working to discover a treatment for this disease and have invested significant levels of funding required for
clinical discovery. We believe there is no treatment comparable to our Cell-in-a-Box® plus low dose of ifosfamide
combination treatment when survival rates and a patient’s quality of life are compared, increasing the potential that our
product candidate will be of value to the oncology community and to pancreatic cancer patients in particular. Further, we believe
that our treatment will become the “treatment choice” for patients with advanced pancreatic cancer because it results
in no meaningful side-affects.
There is, however, intense competition for
the use of the product candidates being developed by us for treating pancreatic cancer patients. There are a number of drugs already
available and in the pipelines of pharmaceutical companies worldwide, not the least of which is the combination of the drugs gemcitabine
and Abraxane®. This is the primary FDA-approved combination of drugs for treating pancreatic cancer. Some of our
competitive strengths include the patents and licensing agreements described in this Report which protect the ability to utilize
encapsulated cells as a critical component of the driving force behind our treatments for cancer and diabetes. Yet many of our
competitors have substantially greater financial and marketing resources than we do. They also have stronger name recognition,
better brand loyalty and long-standing relationships with customers and suppliers. Our future success will be dependent upon our
ability to compete.
Our Cell-in-a-Box® based pancreatic
cancer therapy has already shown promise through the completion of a Phase 1/2 and a Phase 2 clinical trial in advanced, inoperable
pancreatic cancer. The same is true of our diabetes cell therapy. The already completed research studies demonstrated positive
responses in animal models using the Melligen cells. We believe we are in a strong competitive position in light of our unique
encapsulation technology and the genetically modified cells that we have the exclusive world-wide license to use in the encapsulation
process.
Earlier Clinical Trials Using Live Cell Encapsulation
The two earlier clinical trials referred to
above were carried out in Europe in the late 1990s and early 2000s. Both employed the combination of the cellulose-based live cell
encapsulation technology with low doses of the anticancer drug ifosfamide. The results of the two studies have appeared in the
peer-reviewed scientific literature and are summarized as follows:
Phase 1/2 Clinical Trial
Dates
of Trial and Location: The trial was opened on July 28, 1998 and closed on September
20, 1999. The trial was carried out at the Division of Gastroenterology, University of Rostock, Germany.
Identity
of Trial Sponsors: The trial was sponsored by Bavarian Nordic GmbH (“Bavarian
Nordic”).
Trial
Design: The trial was an open-label, prospective, single-arm and single center study.
Patient
Information: A total of 17 patients were enrolled
in the clinical trial (51 were screened). A total of 14 patients were treated because two of the original 17 patients developed
severe infections before the start of the clinical trial and had to be treated by other means. For the other patient, an angiography
was not successful, causing the patient to be disqualified from participating in the clinical trial.
Trial
Criteria: Criteria for enrolling in the clinical
trial included inoperable pancreatic adenocarcinoma stage III-IV (IUCC) as determined by histology and measured by CAT scan and
with no prior chemotherapy.
Duration
of Treatment and Dosage Information: On day 0, celiac
angiography was performed and 300 (in 13 patients, 250 in one) of the capsules containing the ifosfamide-activating cells were
placed by supraselective catheterization of an artery leading to the tumor. Each capsule (~0.8 mm in diameter) contained about
10,000 cells. The cells overexpressed CYP2B1, which catalyzed the conversion of the anticancer drug ifosfamide into its “cancer-killing”
form.
On day 1, patients were monitored for
evidence of any clinically relevant adverse reactions, e.g. allergy and/or pancreatitis. On days 2-4, each patient received low-dose
(1 g/m2 body surface area) ifosfamide in 250 ml of normal saline was administered systemically as a 1-hour infusion.
This was accompanied by a 60% dose equivalent of the uroprotector MESNA given as three intravenous injections. This regimen was
repeated on days 23-25 for all but two patients who received only one round of ifosfamide. A total of only two treatments with
ifosfamide were given.
Specific
Clinical Endpoints: Median survival time from the time of diagnosis, the percentage
of patients who survived one year or more and the quality of life of each patient were examined in the clinical trial.
Observational
Metrics Utilized and Actual Results Observed: Standard NCI criteria for evaluating
tumor growth were used to assess stable disease (“SD”; tumors 50-125% of initial size), partial remission (“PR”;
more than 50% reduction in tumor volume) and minor response (“MR”; tumor reduction of between 25% and 50%).
Effects of the treatment on tumor size
were measured by CAT scans. Control CAT scans were scheduled for weeks 10 and 20, respectively. During the final visit a control
angiography was performed. On the initial CAT scan, the scan demonstrating the largest diameter of the primary tumor was identified
and the area measured. Using appropriate landmarks, an identical scan was used for comparison. CAT scans were evaluated by two
unrelated radiologists, one of whom was not involved in the study. After formally finishing the study, patients were followed on
an ambulatory basis with three-monthly visits.
Toxicity was measured based on WHO/NCI
guidelines on common toxicity criteria. The World Health Organization (“WHO”) and the National Cancer Institute (“NCI”)
use standardized classifications of the adverse events associated with the use of cancer drugs. In cancer clinical trials, these
are used to determine if a particular drug or treatment causes unwanted side effects (adverse events) when used under specific
conditions. For example, the most commonly used classification is known as the “Common Terminology Criteria for Adverse Events”
(CTCAE v. 4.0) developed by the NCI in the United States. Most clinical trials carried out in the United States and the United
Kingdom code their adverse event results according to this system which consists of five grades; these are: 1 = mild; 2 = moderate;
3 = severe; 4 = life-threatening; 5 = death. In the studies reported for the CapCell® (now known as Cell-in-a-Box®)
plus low-dose ifosfamide combination in pancreatic cancer patients, the study investigators noted 11 serious adverse events in
7 patients, none of which were believed to be treatment-related.
Each patient’s need for pain medication
and the quality of life (“QOL”) was monitored using a questionnaire established for pancreatic diseases. A QOL questionnaire
for cancer patients, QLQ-C30, had been validated in several languages, but the module for pancreatic cancer per se was still
under development at the time of the study with respect to reliability, sensibility against changes and multicultural validation.
Accordingly, a version of the core questionnaire and a German QOL scale (published in 1995) for pancreas disease patients was used.
QOL data were documented independently from safety and efficacy data by having patients complete an independent questionnaire.
Assessment of QOL data did not interfere with routine documentation of adverse events reported by the patients. QOL questionnaires
were analyzed according to criteria developed by the European Organization for Research and Treatment of Cancer (“EORTC”).
As used in the description of the QOL results discussed in the published report of the Phase 1/2 trial of the CapCell®
plus low-dose ifosfamide combination in pancreatic cancer patients, the questionnaire was used to assess the QOL of patients undergoing
treatment. The QOL was analyzed in a similar manner to the way that a QOL questionnaire developed by the EORTC is usually analyzed.
This latter questionnaire is known as EORTC QLQ-C30. QOL data were available from the baseline evaluation for 14 patients and for
analysis of change for 8 patients.
A clinical benefit score based on variables,
including the “Karnofsky Score” and body weight, was determined. Pain and analgesic consumption were calculated from
the QOL questionnaires. The Karnofsky Score is a scale that is used to attempt to quantify a cancer patient’s general well-being
and activities of daily life. It is often used to judge the suitability of patients for inclusion into clinical trials. As a clinical
trial progresses, a patient’s Karnofsky Score can change. It is also used to assess a patient’s QOL as a clinical trial
progresses. The scale starts at 100 (normal, no complaints, no evidence of disease) and decreases in decrements of 10 down through
50 (requires considerable assistance and frequent medical care) all the way to 10 (moribund, fatal processes progressing rapidly)
and finally to 0 (deceased). Pain intensity was measured on a visual analog scale ranging from 0 (no pain) to 100 (the most intensive
pain imaginable) in increments of 10. Analgesic consumption was assessed using a separate scale in which 0 indicated no regular
consumption of analgesic and 25, 50 and 100 indicated administration of non-steroidal anti-inflammatory drugs or opiates several
times per year, per month or per week, respectively.
The primary tumor did not grow in any
of the 14 patients. Two patients had a partial response (more than 50% reduction in tumor volume); 12 patients exhibited stable
disease (tumor size in the range of 50% to 125% of initial size); and two patients showed a minor response (tumor reduction of
between 25% and 50%).
Median survival time of patients in
this clinical trial was 39 weeks. The one-year survival rate was 36%.
Within the 20-week study period, three
patients died from disease progression (on days 9, 85 and 132). Upon postmortem examination, the patient who died on day 9 from
recurrent pulmonary embolism was found to have extensive tumor necrosis.
The chemotherapy regimen was well tolerated
with no toxicity beyond Grade 2 being detected in any of the 14 patients; thus, there were no obvious treatment-related risks.
Eleven serious adverse events (“SAEs”)
were seen in 7 patients during the study period. None of them were treatment-related (due to capsule implantation or ifosfamide
administration). These SAEs were attributed to underlying disease and/or the effects associated with the disease.
Implantation of the capsules did not
result in any obvious allergic or inflammatory response, and no patients developed pancreatitis during the clinical trial. Some
patients exhibited elevated amylase levels, presumably due to tumor infiltration of the pancreas and limited obstructive chronic
pancreatitis. However, no further increase in amylase levels was seen after angiography and capsule placement.
Only one adverse event (increased lipase
activity on day 15 after installation of the capsules) “may” have been linked to implanting the capsules.
If a “clinical benefit”
is considered to be either no increase or a decrease in pain intensity, then 10 of 14 experienced such a benefit. For 7 of the
patients, this was confirmed by their analgesic consumption. None of these “benefited” patients registered an increase
analgesic usage both in terms of dosage or WHO levels.
None of the patients showed an increased
Karnofsky Score after treatment. However, 7 of the 14 patients had stable Karnofsky Scores at the week 10 assessment. For 4 of
these patients, their indices were still stable at the week 20 assessment.
One patient’s body weight increased
at both weeks 10 and 20 and another patient showed increased weight at week 10 (this patient withdrew from the study and no week
20 weight was obtained). Two patients showed stable body weights at week 10, one of whom dropped out of the study and the other
showed weight loss at week 20.
Two scenarios were used to establish
the overall integrative clinical benefit response, where each patient was given a +2 score for an improved value, a +1 score for
a stable value and a -1 score for a worsened value for each of four criteria (pain, analgesic consumption, Karnofsky Score and
body weight) as compared to the relevant week 0 values.
The “worst case scenario”
required a pain relief score of 20 points or more to be judged an improvement and a decrease in the Karnofsky Score of 10 points
or more to indicate worsening. Using this scenario, 50% or 7 of the treated patients experienced clinical benefit; 21.4% or 3 patients
were neutral (benefits were offset by impairments); and 28.6% or 4 patients had no clinical benefit. The latter included those
passing away before the median survival time.
In the “best case scenario,” a
pain relief score of 10 points or more was an improvement. A decrease in Karnofsky Score of 20 points or more was considered a
worsening. In this scenario, 71.4% or 10 patients had clinical benefit, 14.2% of patients showed neither benefit nor deterioration
and 14.3% patients had no benefit.
Comparisons
to Standard of Care: At the time this clinical trial was conducted, only one FDA-approved
treatment for advanced, inoperable pancreatic cancer was available. That was gemcitabine, an Eli Lilly drug first approved by the
FDA in 1996.
An examination of the prescribing information
for gemcitabine reflects that the median survival seen in the pivotal (Phase 3) pancreatic cancer clinical trial for gemcitabine
was approximately 23 weeks (5.7 months). The percentage of one-year survivors was approximately 18%. In the pivotal (Phase 3) clinical
trial of Celgene’s Abraxane® plus gemcitabine combination that was approved by the FDA in September 2013 for
the treatment of patients with advanced inoperable pancreatic cancer, the median survival time for patients was about 8.5 months
and the percentage of one-year survivors was approximately 35%. By comparison, corresponding values from the Phase 1/2 reported
clinical trial of the CapCell® (now known as Cell-in-a-Box®) plus ifosfamide combination were 39
weeks (approximately 9.8 months) and 36%, respectively.
The treatment with gemcitabine of patients
with pancreatic cancer is often associated with severe side effects. According to the prescribing information for gemcitabine,
for use against pancreatic cancer the recommended dose is 1000 mg/m2 given intravenously over 30 minutes. The schedule
of administration is: weeks 1-8, weekly dosing for 7 weeks followed by one week rest and then after week 8, weekly dosing on days
1, 8 and 15 of 28-day cycles.
Reductions in the doses of gemcitabine
are necessitated by the occurrence of myelosuppression. Permanent discontinuation of gemcitabine is necessary for any of
the following:
| · | unexplained dyspnea or other evidence of severe pulmonary toxicity; |
| · | hemolytic-uremic syndrome; |
| · | capillary leak syndrome; and |
| · | posterior reversible encephalopathy syndrome. |
Gemcitabine should be withheld or its dose
reduced by 50% for other severe (Grade 3 or 4) non-hematologic toxicity until that toxicity is resolved.
In contrast to the SAE’s seen with gemcitabine,
as noted above under Observational Metrics Utilized and Actual Results Observed, the use of the CapCell®
plus ifosfamide combination in this Phase 1/2 clinical trial was not associated with any serious (Grade 3 or 4) treatment-related
side effects.
Conclusions:
In the opinion of trial’s investigators only, in the Phase 1/2 clinical trial the use of
the combination of CapCell® (now known as Cell-in-a-Box®) plus low-dose ifosfamide is both safe and
efficacious. This assessment was not based on the opinion of any drug regulatory authority and does not guarantee that that this
assessment will be maintained in any late-phase clinical trial or that any drug regulatory authority will ultimately determine
that the CapCell® (now known as Cell-in-a-Box®) plus low-dose ifosfamide combination is safe and
effective for the purposes of granting marketing approval.
In the Phase1/2 trial only a small number of
patients were evaluable. As a result, statistical parameters were not used in the published reports of the Phase 1/2 trial to validate
the anticancer efficacy of the Cell-in-a-Box® plus low-dose ifosfamide combination in patients with advanced, inoperable
pancreatic cancer. In the opinion of the investigators, the results indicate a trend towards efficacy, so the results should not
be viewed as absolute numbers. It should be noted, however, that because the results were not statistically significant, any observations
of efficacy must be weighed against the possibility that the results were due to chance alone. The purpose of the clinical trial
was not to obtain data so that marketing approval could be obtained from regulatory authorities, but rather the clinical trial
allowed us to determine whether the Cell-in-a- Box® plus low-dose ifosfamide combination holds promise as a treatment
for advanced pancreatic cancer. In the cancer arena, Phase 1/2 clinical trials are used to first establish the safety of drug or
treatment being investigated and second to determine if a trend towards efficacy exists. In accordance with FDA guidance, as well
as similar guidance from other regulatory authorities in countries other than the United States, we fully realize that a large,
multicenter, randomized, comparative study with statistically powerful findings would need to be conducted and the results from
such a clinical trial would have to confirm those from the previous Phase 1/2 trial before an application for marketing approval
could be made for the Cell-in-a-Box® plus low-dose ifosfamide combination as a treatment for advanced pancreatic
cancer.
If the cancer treatment were approved by the
Regulatory Agencies (defined below under “Government Regulations for Drug Development”), it could provide a significant
benefit to those with this devastating and deadly disease, not only in terms of life-span but also in terms of increased quality
of life. In addition, success of the live cell encapsulation technology in the pancreatic cancer setting may lead to its successful
use in developing treatments for other forms of cancer after preclinical studies and clinical trials have been completed.
Phase 2 Clinical Trial
Location
of Trial: The trial was opened on November 16, 1999 and closed on December 1, 2000.
This trial was carried out at four centers in two countries in Europe; these were in Berne, Switzerland, and in Rostock, Munich
and Berlin in Germany.
Trial
Sponsor: The clinical trial was sponsored by Bavarian Nordic.
Trial
Design: This was an open-label, prospective, single-arm, multi-site study.
Patient
Information: All 13 patients enrolled in the trial were treated. Twelve patients exhibited Stage IV disease. The remaining
patient had Stage III disease. Ten of the 13 patients exhibited metastases.
Duration
of Treatment and Dosage Information: The number of capsules implanted varied 221 to
300 with a mean of 244. On day 1, patients were monitored for any allergic reactions to capsule implantation and or pancreatitis.
The administration schedule of the treatment was as for the Phase 1/2 trial except that in this Phase 2 trial, the dose of ifosfamide
was doubled to 2 g/m2 from the 1g/m2 used in the Phase 1/2 trial. On days 2-4, patients received 2 g/m2
in normal saline as a one-hour infusion. In addition, the urinary tract protector MESNA was given as 3 intravenous injections.
This regimen was repeated on days 23-25.
Specific
Clinical Endpoints: The primary objective was to determine response rate as defined
by SD, PR and MR as well as the clinical benefit (Karnofsky score) of the treatment. The timing of the tumor size measurements
(by CT scan) and determination of tumor sizes were done by independent radiologists. A secondary endpoint of the study was to determine
time to progression, tumor response, duration of partial or complete remission, length of symptom-free survival, survival time
and quality of life. Another secondary aim was to evaluate the safety and tolerability of the treatment regimen, with attention
being paid to the appearance of pancreatitis or immediate allergic reactions.
Safety
Analysis of Angiography, Capsule Implantation and Chemotherapy: On average, angiography
took approximately 40 minutes. For 5 of the patients in this clinical trial, more than one blood vessel had to be used for placement
of the capsules. The administration of the capsules was well tolerated in this Phase 2 clinical trial. There were no signs of allergic
reactions or hemorrhagic cystitis after implantation of the capsules. Two patients had increased levels of serum lipase at baseline.
After additional measurements, these were not considered to be clinically relevant. The dose of ifosfamide (2 g/m2)
used was found to be toxic in the majority of patients. This resulted in one patient having to reduce the ifosfamide dose in the
second of the two cycles of treatment with the drug. The most common toxic effects were nausea, vomiting, malaise, anorexia and
mild hematuria.
Serious
Adverse Events: A total of 16 SAEs were documented in eight patients, including 3 SAEs
leading to death. None of these SAEs could be attributed to placement of the encapsulated cells. One patient experienced neurological
impairment (drowsiness, nocturnal enuresis, mild somnolence) which was attributed to treatment with the 2 g/m2 dose
of ifosfamide. All of the patients experienced between 5 and 19 SAEs. Six SAEs were rated as life-threatening; 10.2% were rated
as severe; 28.7% were rated as moderate; and 53.7% were rated as mild. None of the AEs was thought to be related to placement of
the encapsulated cells, but 44% were related to the administration of ifosfamide at the dose given. Most frequent SAEs were alopecia,
anemia, leucopenia, nausea and vomiting or encephalopathy. Other SAEs were new or worse symptoms of the patients’ underlying
disease. A total of 65 events met the National Cancer Institute’s common toxicity criteria. Of these, 46.2% had Grade 1,
40% had Grade 2, 9.2% had Grade 3 and 4.6% had Grade 4 toxicities.
Tumor
Reductions and Patient Survival Results: The size of the primary tumor was measured prior to stating ifosfamide treatment and
at weeks 10 and 20 post-treatment. No partial remissions were observed, but 4 patients exhibited tumor size reductions, 4 patients
showed tumor growth and the remaining 5 patients had stable disease over the “follow-up” period after chemotherapy.
The median survival of patients was 40 weeks.
The majority of the survival benefit was shown early during the entire observation period. However, as time progressed, these patients
succumbed at the same rate as historical controls. This observation suggested to the investigators that prolongation of the survival
benefit might be achieved if additional courses of ifosfamide chemotherapy were given. The one year survival rate was 23%. It was
thought that this may be attributable to the higher dose of ifosfamide used in this Phase 2 clinical trial.
Quality
of Life: An assessment of the quality of life of the patients was performed in this
Phase 2 clinical trial. Quality of life data were available for all of the patients. According to this quality of life assessment,
although pain during the night decreased, patients felt themselves to be less attractive and lost interest in sex. No additional
improvements in patients’ quality of life were observed.
Conclusions:
The opinions of the investigators were are follows: (i) the lack of “problems” associated with the implanted encapsulated
cells was noted as in the Phase 1/2 trial; (ii) administering more than two courses of treatment with ifosfamide might have beneficial
effects on survival; and (iii) since doubling the dose of ifosfamide from that used in the Phase 1/2 trial had no beneficial antitumor
or survival effect but was associated with increased side effects from the treatment, the dose of ifosfamide to be used in combination
with the encapsulated cells for all future trials should be 1g/m2.
Manufacturing
We are outsourcing all cell growth,
processing and encapsulation services needed in connection with our future clinical trials of the encapsulated cell based cancer
and diabetes treatments.
We have engaged ViruSure, a professional
cell growing and adventitious agent testing company that has had extensive experience with the CYP2B1-expressing cells that will
be needed for our pancreatic cancer treatment. We did so in order to recover them from frozen stocks of similar cells and regenerate
new stocks for use by us in our preclinical studies and clinical trials. ViruSure is in the process of cloning new cells from a
selected clone. Those clones will be grown to populate a MCB and WCB for our future clinical trials. There are approximately $195,000
in future milestone payments relating to testing to be completed.
We have entered into a Manufacturing Framework
Agreement with Austrianova pursuant to which it will encapsulate the genetically modified cells that will be used for our cancer
treatment. We also have contracted with Austrianova to provide encapsulated insulin-producing cells for our preclinical studies
in diabetes. For the pancreatic cancer studies, we anticipate incurring approximately $112,000 in costs associated with the encapsulation
of the cells. At the appropriate time, we will enter into a similar Manufacturing Framework Agreement with Austrianova for the
encapsulated cells we will need for our clinical trial in diabetes.
Government Regulations for Drug Development
The United States’ Food and Drug
Administration (“FDA”), Europe’s European Medicines Agency (“EMA”), Australia’s Therapeutic
Goods Administration (“TGA”) and other country-specific regulatory agencies around the world (collectively, “Regulatory
Agencies”) ensure the safety of the entire community through their regulations pertaining to new drugs. Regulation by governmental
authorities plays a significant factor in the manufacture and marketing of pharmaceuticals and in our ongoing research and development
activities. Our therapeutic products require regulatory approval by the Regulatory Agencies. Human therapeutic products are subject
to rigorous preclinical testing and clinical trials and other pre-marketing and post-marketing approval requirements of the Regulatory
Agencies. In the United States, various federal and, in some cases, state statutes and regulations also govern or impact the manufacturing,
testing for safety and effectiveness, labeling, storage, record-keeping and marketing of such products. The lengthy process of
seeking required approvals and the continuing need for compliance with applicable statutes and regulations require the expenditure
of substantial resources. Regulatory approval, if and when obtained, may be limited in scope which may significantly limit the
uses for which a product may be placed into the market. Further, approved drugs, as well as their manufacturers, are subject to
ongoing post-marketing review, inspection and discovery of previously unknown problems with such products or the manufacturing
or quality control procedures used in their production, which may result in restrictions on their manufacture, sale or use or in
their withdrawal from the market. Any failure or delay by us, our suppliers of manufactured drug product, collaborators or licensees
in obtaining regulatory approvals could adversely affect the marketing of our products and our ability to receive product revenue,
license revenue or profit sharing payments. For more information, see Item 1A. “Risk Factors.”
Clinical Development
Before a product may be administered
to human subjects, it must undergo preclinical testing. Preclinical tests include laboratory evaluation of a product candidate’s
chemistry and biological activities and animal studies to assess potential safety and efficacy. The results of these studies must
be submitted to the Regulatory Agencies as part of an Investigational New Drug (“IND”) application which must be reviewed
by the Regulatory Agencies for safety and other considerations before clinical trials in humans can begin.
Typically, clinical trials in humans
involve a three-phase process. We devote significant resources to research and development programs in an effort to discover and
develop potential future product candidates. The product candidates in our pipeline are at various stages of preclinical and clinical
development. The path to regulatory approval includes three phases of clinical trials in which we collect data to support an application
to Regulatory Agencies to allow us to market a product for treatment of a specified disease. There are many difficulties and uncertainties
inherent in research and development of new products, resulting in a high rate of failure. To bring a drug from the discovery phase
to regulatory approval, and ultimately to market, takes many years and significant cost. Failure can occur at any point in the
process, including after the product is approved, based on post-marketing factors. New product candidates that appear promising
in development may fail to reach the market or may have only limited commercial success because of efficacy or safety concerns,
inability to obtain necessary regulatory approvals, limited scope of approved uses, reimbursement challenges, difficulty or excessive
costs of manufacture, alternative therapies or infringement of the patents or intellectual property rights of others. Uncertainties
in the approval process of the Regulatory Agencies can result in delays in product launches and lost market opportunities. Consequently,
it is very difficult to predict which products will ultimately be submitted for approval, which have the highest likelihood of
obtaining approval and which will be commercially viable and generate profits. Successful results in preclinical or clinical studies
may not be an accurate predictor of the ultimate safety or effectiveness of a drug or product candidate.
Phase 1 Clinical Trials:
Phase 1 clinical trials begin when Regulatory Agencies allow initiation of clinical investigation of a new drug or product
candidate. The clinical trials study a drug’s safety profile and may include a preliminary determination of a drug or product
candidate’s safe dosage range. The Phase 1 clinical trial also determines how a drug is absorbed, distributed, metabolized
and excreted by the body and, therefore, the potential duration of its action.
Phase 2 Clinical Trials:
Phase 2 clinical trials are conducted on a limited number of subjects with the targeted disease. An initial evaluation of
the drug’s effectiveness on subjects is performed and additional information on the drug’s safety and dosage range
is obtained. For many diseases, Phase 2 clinical trials normally include up to several hundred subjects.
Phase 3 Clinical Trials:
Phase 3 clinical trials are typically controlled multi-center trials that involve a larger target patient population that
can consist of from several hundred to thousands of subjects to ensure that study results are statistically significant. During
Phase 3 clinical trials, physicians monitor subjects to determine efficacy and to gather further information on safety. These
trials are designed to generate all of the clinical data necessary to submit an application for marketing approval to Regulatory
Agencies.
Regulatory Review: If
a product candidate successfully completes Phase 3 clinical trials and is submitted to Regulatory Agencies, such as the FDA
in the United States and the EMA in Europe, the time to final marketing approval can vary from six months to several years, depending
on a number of variables. These variables can include such things as the disease type, the strength and complexity of the data
presented, the novelty of the target or compound, risk-management approval and whether multiple rounds of review are required for
the agency to evaluate the submission. There is no guarantee that a potential treatment will receive marketing approval or that
decisions on marketing approvals or treatment indications will be consistent across geographic areas. In some cases, further studies
beyond the three-phase clinical trial process described above are required as a condition for approval of a New Drug Application
(“NDA”), a Marketing Authorization Application (“MAA”) or a Biologics License Application (“BLA”).
The Regulatory Agencies require monitoring of all aspects of clinical trials and reports of all adverse events must be made. The
Regulatory Agencies may also require the conduct of pediatric studies for the drug and indication either before or after submission
of a NDA or a BLA.
Review and Approval by Regulatory
Agencies
The results of the preclinical testing,
production parameters and clinical trials are submitted to the Regulatory Agencies as part of a NDA, MAA or a BLA for evaluation
to determine if there is substantial evidence that the product is sufficiently safe and effective to warrant approval. In responding
to a NDA, MAA or a BLA, the Regulatory Agencies may grant marketing approval, deny approval or request additional information.
Expedited Programs for Serious
Conditions
Regulatory Agencies have developed distinct
approaches to make new drugs available as rapidly as possible in cases where there is no available treatment or there are advantages
over existing treatments. For example, the FDA may grant “accelerated approval” to products that have been studied
for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit
to patients over existing treatments. For accelerated approval, the product must have an effect on a surrogate endpoint or an intermediate
clinical endpoint that is considered reasonably likely to predict the clinical benefit of a drug, such as an effect on irreversible
morbidity and mortality. When approval is based on surrogate endpoints or clinical endpoints other than survival or morbidity,
the sponsor will be required to conduct additional post-approval clinical studies to verify and describe clinical benefit. These
studies are known as confirmatory trials. Approval of a drug may be withdrawn or the labeled indication of the drug changed if
these trials fail to verify clinical benefit or do not demonstrate sufficient clinical benefit to justify the risks associated
with the drug.
The FDA may grant “Fast Track”
status to products that treat serious diseases or conditions and fill an unmet medical need. Fast track is a process designed to
facilitate the development and expedite the review of such products by providing, among other things, more frequent meetings with
the FDA to discuss the product’s development plan, more frequent written correspondence from the FDA about trial design,
eligibility for accelerated approval if relevant criteria are met and rolling review, which allows submission of individually completed
sections of a NDA or a BLA for Regulatory Agency review before the entire submission is completed. Fast track status does not ensure
that a product will be developed more quickly or receive Regulatory Agency approval.
The FDA’s “Breakthrough
Therapy” designation for a drug is designed to expedite the development and review of drugs that are intended to treat a
serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available
therapy on a clinically significant endpoint. For drugs and biologics that have been designated as Breakthrough Therapies, robust
FDA-sponsor interaction and communication can help to identify the most efficient and expeditious path for clinical development
while minimizing the number of patients placed in ineffective control regimens.
The FDA may grant “Priority Review”
status to products that, if approved, would provide significant improvement in the safety or effectiveness of the treatment, diagnosis
or prevention of serious conditions. Priority review is intended to reduce the time it takes for the FDA to review a NDA or a BLA,
with the goal to take action on the application within six months.
Orphan Drug Status
In accordance with laws and regulations
pertaining to the Regulatory Agencies, a sponsor may request that the Regulatory Agencies designate a drug intended to treat a
“Rare Disease or Condition” as an “Orphan Drug.” For example, in the United States, a “Rare Disease
or Condition” is defined as one which affects less than 200,000 people in the United States, or which affects more than 200,000
people but for which the cost of developing and making available the product is not expected to be recovered from sales of the
product in the United States. Upon the approval of the first NDA or BLA for a drug designated as an orphan drug for a specified
indication, the sponsor of that NDA or BLA is entitled to 7 years of exclusive marketing rights in the United States unless the
sponsor cannot assure the availability of sufficient quantities to meet the needs of persons with the disease. In Europe, this
exclusivity is 10 years, and in Australia it is 5 years. However, orphan drug status is particular to the approved indication and
does not prevent another company from seeking approval of an off-patent drug that has other labeled indications that are not under
orphan or other exclusivities. Orphan drugs may also be eligible for federal income tax credits for costs associated with such
as the disease state, the strength and complexity of the data presented, the novelty of the target or compound, risk-management
approval and whether multiple rounds of review are required for the agency to evaluate the submission. There is no guarantee that
a potential treatment will receive marketing approval or that decisions on marketing approvals or treatment indications will be
consistent across geographic areas.
Patents, Intellectual Property and Trade Secrets
Intellectual property (“IP”)
and patent protection are of paramount importance to our business, as are the trade secrets and other strategies we have employed
with Austrianova to protect the proprietary Cell-in-a-Box® technology. Although we believe we take reasonable measures
to protect our IP and trade secrets and those of Austrianova, we cannot guarantee we will be able to protect and enforce our IP
or obtain international patent protection for our products as needed. We and some of our subsidiaries license patents and trademarks
and have exclusive worldwide licensing rights to numerous patents in multiple countries over three technical areas: (i) live cell
encapsulation; (ii) treatment of solid cancerous tumors; and (iii) encapsulation of cells for producing retroviral particles for
gene therapy. In addition, we have exclusive worldwide licensing rights to patents, trademarks and know-how using Cell-in-a-Box®
technology in the diabetes field and in the treatment of diseases and related conditions using the constituents of Cannabis.
Litigation may be required to protect our products, IP rights and trade secrets or to determine the validity and scope of the proprietary
rights of others. Maintenance of our IP utilizes financial and operational resources. In addition, the possibility exists that
our IP could be discovered to be owned by others, be invalid or be unenforceable, potentially bringing unforeseen challenges to
us.
Patents and Intellectual
Property Agreements
The following patents and agreements constitute
our material IP:
| · | We have a License Agreement Relating to Encapsulated Cells Producing Viral Particles and Encapsulated
Cells Expressing Biomolecules (“Bavarian Nordic/GSF License”). The licensors are Bavarian Nordic and GSF –
Forschungszentrum fur Umwelt u. Gesundheit GmbH. The licensee is Bio Blue Bird, our wholly owned subsidiary. The License Agreement
was signed in July 2005. The licensors have rights to terminate the license in the event that the annuity and upkeep fees are not
paid to Bavarian Nordic, there is not proper reporting or there is not a clearly documented effort to commercialize this technology; |
| · | The Bavarian Nordic/GSF License relates to the patent US 6893634 B1 that claims “A capsule
comprising a porous membrane formed by a polyelectrolyte complex which encapsulates cells which express cytochrome P450 as a cell
membrane bound protein, wherein the porous membrane of the capsule is permeable to prodrug molecules and the cells are retained
within the capsule” and further claims based on this; |
| · | We have an exclusive license to the US Patent US 6,776,985 B1 that claims “Encapsulated retroviral
packaging cells producing retroviral vectors, comprising capsules having a porous capsule wall which is permeable to said retroviral
particles” and further claims based on this. This patent would be broadly applicable to the delivery of retroviral vectors
by encapsulated packaging cells for a variety of indications; |
| · | We acquired 100% ownership of Bio Blue Bird, the licensee of the patents identified above; |
| · | We have an exclusive license world-wide to use the Cell-in-a-Box® technology
with genetically modified or non-modified non-stem cell lines and induced pluripotent stem (iPS) cells, with the right to sublicense,
designed to produce insulin or other critical components for the treatment of diabetes. We must enter into a research program involving
European academic research partners providing a total funding of at least US$400,000 within three years of June 25, 2013 and must
enter clinical trials within 7 years of June 25, 2013 to retain the exclusive world-wide license; |
| · | We have an exclusive license world-wide to use the Cell-in-a-Box® trademark and its associated
technology with genetically modified non-stem cell lines which are designed to activate members of the cannabinoid family of molecules
derived from Cannabis, with the right to sublicense, to develop therapies involving Cannabis, including the activation of cannabinoids.
We must enter into a research program involving the scope of the Cannabis Licensing Agreement within three years of December 1,
2014 and must enter clinical trials within 7 years of December 1, 2014 to retain the exclusive world-wide license. We must also
pay the Upfront Payment of $2,000,000 in full by December 31, 2015; and |
| · | We have a License Agreement with UTC pursuant to which we acquired the exclusive license world-wide
to use genetically modified cells, named Melligen, that have been modified to comprise pancreatic islet cell glucokinase for use
in developing a treatment for insulin-dependent diabetes. |
We have assumed Bio Blue Bird’s responsibilities
under the Bavarian Nordic/GSF License, which include making royalty payments and bearing all of the licensor’s external costs
and fees for filing, prosecuting and maintaining any patent claims covering inventions in the licensed patent product. The only
other payment obligations we have are the quarterly encapsulation patent upkeep fees to Bavarian Nordic, yearly license maintenance
fees and auditing fees. We are to devote all reasonable efforts to develop product as promptly as possible, provide licensors with
updates on the progress of the development and sale of the products and a summary of results of clinical study protocols regarding
human clinical trials at the end of a pivotal (for marketing application purposes) trial, such as Phase 3 clinical trials, and
devote all reasonable efforts to commence manufacturing and commercialization as promptly as possible. We are also responsible,
at our expense, for conducting any recalls of defective licensed products marketed by us.
Our royalty payments commence on the date
of the first commercial sale of the licensed product in a particular country and continue on a country by country basis until
expiration of the last valid claim within the licensed patent rights in such country. The territories where such commercial sales
are anticipated are in the United States, Europe and Japan. The future royalty and milestone payments are as follows: (i) approximately
seven percent royalty on all gross sales; (ii) approximately eight percent royalty on gross revenues from sublicensing; (iii)
milestone payments of $130,000 after the enrollment of the first human patient in the first Phase 3 clinical trial; (iv) an additional
$130,000 after the conclusion of the Phase 3 clinical trial; and (v) $650,000 after obtaining a marketing authorization. The patents
expire starting in 2016 through 2017.
Summary of Patents
Set forth in the tables below is information
regarding the relevant patents described above:
Encapsulated Cells Producing Cytochrome
P450
| · | Claims cover capsules encapsulating a cell expressing cytochrome P450 and treatment methods using
same. |
| · | There are no contested proceedings or third party claims known to us. |
| · | All major countries provide for patent term extension. |
| · | We have an exclusive license from joint patent owners Bavarian Nordic/GSF. |
Patent No. |
|
Expiration Date |
|
Country |
US 6,540,995 |
|
03/27/2017 |
|
US |
US 6,893,634 |
|
03/27/2017 |
|
US |
AU 713382 |
|
03/27/2017 |
|
Australia |
EP 892852 |
|
03/27/2017 |
|
Switzerland |
EP 892852 |
|
03/27/2017 |
|
Germany |
EP 892852 |
|
03/27/2017 |
|
Spain |
EP 892852 |
|
03/27/2017 |
|
France |
EP 892852 |
|
03/27/2017 |
|
Great Britain |
EP 892852 |
|
03/27/2017 |
|
Italy |
IL 125795 |
|
03/27/2017 |
|
Israel |
JP 4229982 |
|
03/27/2017 |
|
Japan |
Encapsulated Cells Producing
Retroviral Particles
| · | Claims cover capsules which have walls that are permeable to retroviral particles, methods for producing same and methods of
using same for gene therapy in countries where this protection is available. |
| · | There are no contested proceedings or third party claims known to us. |
| · | All major countries provide for patent term extension. |
| · | We have an exclusive license from joint patent owners Bavarian Nordic/GSF. |
Patent No. |
|
Expiration Date |
|
Country |
US 6,776,985 |
|
06/24/2016 |
|
US |
AU 708273 |
|
06/24/2016 |
|
Australia |
EP 835137 |
|
06/24/2016 |
|
Switzerland |
EP 835137 |
|
06/24/2016 |
|
Germany |
EP 835137 |
|
06/24/2016 |
|
Spain |
EP 835137 |
|
06/24/2016 |
|
France |
EP 835137 |
|
06/24/2016 |
|
Great Britain |
EP 835137 |
|
06/24/2016 |
|
Italy |
IL 122119 |
|
06/24/2016 |
|
Israel |
JP 4119852 |
|
06/24/2016 |
|
Japan |
JP 4848348 |
|
06/24/2016 |
|
Japan |
KR 484883 |
|
06/24/2016 |
|
South Korea |
Third Addendum to the SG Austria
APA
On May 26, 2011, we entered into the
SG Austria APA. As a result, Austrianova and Bio Blue Bird were to become wholly-owned subsidiaries of ours on the condition that
we pay SG Austria $2.5 million and 100,000,000 shares of our common stock and for us to receive 100,000 shares of Austrianova’s
common stock and nine Bio Blue Bird bearer shares evidencing ownership of Bio Blue Bird.
In June 2011, we and SG Austria entered
into a First Addendum to the SG Austria APA to extend the due date for the sums to be paid to SG Austria. In June 2012, we and
SG Austria entered into the Second Addendum to the SG Austria APA for the same purpose. In June 2013, we and SG Austria entered
into the Third Addendum.
Under the terms of the Third Addendum,
the transaction contemplated by the SG Austria APA was materially changed. The Third Addendum provided that we were to acquire
100% of the equity interests in Bio Blue Bird and receive a 14.5% equity interest in SG Austria. In addition, we received nine
bearer shares of Bio Blue Bird representing 100% ownership. Under the Third Addendum, we paid: (i) $500,000 to retire all outstanding
debt of Bio Blue Bird; and (ii) $1.0 million to SG Austria. We acquired a 14.5% interest in SG Austria for $1,572,193 in cash previously
paid to SG Austria to maintain SG Austria from the date of the SG Austria APA until the closing of the Third Addendum. The Third
Addendum returned the original 100,000,000 shares of common stock to our treasury and returned to SG Austria the 100,000 Austrianova
shares we had received under the SG Austria APA.
The acquisition of Bio Blue Bird provided
us with exclusive, worldwide licenses to use a proprietary cellulose-based live cell encapsulation technology for the development
of treatments for all forms of cancer with a right to sublicense. These licenses enable us to carry out the research and development
of cancer treatments that are based upon the Cell-in-a-Box® technology. The license relates in general terms to
encapsulation of cells that: (i) produce viral particles; (ii) express biomolecules; or (iii) convert molecules from one form to
another pursuant to a License Agreement from Bavarian Nordic/GSF as the licensor and Bio Blue Bird as the licensee, as amended.
The Third Addendum requires us to make
the following payments for the purchased assets, which payments were timely made in full under the payment deadlines set forth
in the Third Addendum:
| · | A $60,000 payment due under the SG Austria APA; |
| · | A payment of Stamp Duty estimated to be $10-17,000 to the Singapore Government; |
| · | $500,000 to be used to pay off the existing debt of Bio Blue Bird; and |
The Third Addendum provides that if
the payments listed above are insufficient or fail to meet specified payment deadlines, the Third Addendum and the SG Austria APA
automatically terminate and will be deemed null and void.
The Third Addendum requires us to pay
SG Austria, pursuant to a manufacturing agreement between the parties, a one-time manufacturing setup fee in the amount of $633,144.05,
of which 50% is required to be paid on the signing of the manufacturing agreement and 50% is required to be paid three months later.
In addition, the Third Addendum requires us to pay a fee for producing the final encapsulated cell product of $633.14 per vial
of 300 capsules after production with a minimum purchased batch size of 400 vials of any Cell-in-a-Box® product.
The Third Addendum is an outright purchase.
The Third Addendum requires us to make future royalty and milestone payments as follows:
| · | Two percent royalty on all gross sales received by us or our affiliates; |
| · | Ten percent royalty on gross revenues received by us or our affiliates from any sublicense or right
to use the patents or the licenses granted by us or our affiliates; |
| · | Milestone payments of $100,000 due 30 days after enrollment of the first human patient in the first
clinical trial for each product; $300,000 due 30 days after enrollment of the first human patient in the first Phase 3 clinical
trial for each product; and $800,000 due 60 days after having a NDA or a BLA approved by the FDA or a MAA approved in Europe or
its equivalent based on the country in which it is accepted for each product; and |
| · | Milestone payments of $50,000 due 30 days after enrollment of the first veterinary patient in the
first trial for each product and $300,000 due 60 days after having a BLA, a NDA or a MAA or its equivalent approved based on the
country in which it is accepted for each veterinary product. |
We were granted a right of first refusal
pursuant to the Third Addendum with respect to any offers made by SG Austria related to the granting of a license with respect
to any patents or technologies related to live cell encapsulation that can be applied to use the Cell-in-a-Box®
technology to create products in the following areas: (i) dermal fillers; (ii) medical marijuana; (iii) diabetes; and (iv) virally
caused infectious diseases.
Diabetes Licensing Agreement
Pursuant to the Diabetes Licensing Agreement,
we acquired from Austrianova the exclusive license worldwide to use the cellulose-based live cell encapsulation technology for
the development of a treatment for diabetes and the use of Austrianova’s Cell-in-a-Box® trademark for this
technology with a right to sublicense. The licensed rights pertain to genetically modified or non-modified non-stem cell lines
and certain stem cells specifically designed to produce insulin or other critical components for the treatment of diabetes.
Under the Diabetes Licensing Agreement,
we are required to make a payment of $2,000,000 in two equal payments of $1,000,000 each. We made our first $1,000,000 payment
on October 30, 2013. Our second payment of $1,000,000 was made on February 25, 2014.
The Diabetes Licensing Agreement requires
us to pay Austrianova, pursuant to a manufacturing agreement between the parties, a one-time manufacturing setup fee in the amount
of $633,144, of which 50% is required to be paid on the signing of a manufacturing agreement for a product and 50% is required
to be paid three months later. In addition, the Diabetes Licensing Agreement requires us to pay a fee for producing the final encapsulated
cell product of $633.14 per vial of 300 capsules after production with a minimum purchased batch size of 400 vials of any Cell-in-a-Box®
product.
The Diabetes Licensing Agreement requires
us to make future royalty and milestone payments as follows:
| · | Ten percent royalty of the gross sale of all products we sell; |
| · | Twenty percent royalty of the amount actually received by us from sub-licensees on sub-licensees’
gross sales; and |
| · | Milestone payments of $100,000 within 30 days of beginning the first pre-clinical experiments using
the encapsulated cells; $500,000 within 30 days after enrollment of the first human patient in the first clinical trial; $800,000
within 30 days after enrollment of the first human patient in the first Phase 3 clinical trial; and $1,000,000 due 60 days after
having a NDA or a BLA approved by the FDA or a MAA approved in Europe or its equivalent based on the country in which it is accepted
for each product. |
The license under the Diabetes Licensing
Agreement may be terminated and all rights will revert to Austrianova if any of the following milestone events do not occur within
the following timeframes:
| · | If we do not enter into a research program with technology in the scope of the license involving
European academic university partners providing a total funding equal to or greater than $400,000 within three years of the effective
date of the Diabetes Licensing Agreement; or |
| · | If we do not enter into a clinical trial or its equivalent for a product within seven years of
the effective date of the Diabetes Licensing Agreement. |
Melligen Cell License Agreement
Pursuant to the Melligen Cell License Agreement,
we acquired the exclusive license world-wide to use genetically modified cells that have been modified to produce, store and then
release insulin “on demand” in developing a treatment for insulin-dependent diabetes. In addition, we obtained the
non-exclusive worldwide rights to “know-how” associated with the Melligen cells. These cells have been shown to be
able to produce, store and secrete insulin “on demand” in response to changing levels of blood sugar in the cells’
surroundings. We intend to use the Melligen cells, after they have been encapsulated using our Cell-in-a-Box® technology,
as a treatment for insulin-dependent diabetes.
The Melligen Cell License Agreement does not
require any “up-front” payment to UTS. We are required to pay to UTS a Patent Administration Fee equal to 15% of all
amounts paid by UTS to prosecute and maintain patents related to the licensed property.
The Melligen Cell License Agreement requires
that we pay royalty and milestone payments to UTS as follows:
| · | Six percent gross exploitation revenue on product sales; |
| · | Twenty-five percent of gross revenues if the product is sub-licensed by us; and |
| · | Milestone payments of AU$ 50,000 at the successful conclusion of clinical studies, AU$ 100,000
at the successful conclusion of Phase 1 clinical trials, AU$ 450,000 at the successful conclusion of Phase 2 clinical trials, and
AU$ 3,000,000 at the conclusion of Phase 3 clinical trials. |
In the event of a default under the Melligen
Cell License Agreement, the non-defaulting party may immediately terminate the agreement by notice in writing to the defaulting
party if: (i) the default has continued for not less than 14 days or occurred more than 14 days earlier and has not been remedied;
(ii) the non-defaulting party serves upon the defaulting party notice in writing requiring the default to be remedied within 30
days of such notice, or such greater number of days as the non-defaulting party may in its discretion allow, and (iii) the defaulting
party has failed to comply with the notice referred to in (ii) above.
Cannabis Licensing Agreement
Pursuant to the Cannabis Licensing Agreement,
we acquired from Austrianova an exclusive license world-wide to use the Cell-in-a-Box® trademark and its associated
technology with genetically modified non-stem cell lines which are designed to activate cannabinoids to develop therapies involving
Cannabis.
Under the Cannabis Licensing Agreement, we
are required to pay Austrianova an Upfront Payment of $2,000,000. We have the right to make periodic monthly partial payments of
the Upfront Payment in amounts to be agreed upon between the parties prior to each such payment being made. Under the Cannabis
Licensing Agreement, the Upfront Payments must be paid in full by no later than June 30, 2015. As of the date of this Report, we
have paid Austrianova $1.3 million of the Upfront Payment. The parties have agreed to an amendment to the Cannabis Licensing Agreement
pursuant to which the balance of the Upfront Payment will be due by December 31, 2015. That amendment is in the process of being
documented.
The Cannabis Licensing Agreement requires
us to pay Austrianova, pursuant to a manufacturing agreement between the parties, a one-time manufacturing setup fee in the amount
of $800,000, of which 50% is required to be paid on the signing of a manufacturing agreement for a product and 50% is required
to be paid three months later. In addition, the Cannabis Licensing Agreement requires us to pay a fee for producing the final encapsulated
cell product of $800 per vial of 300 capsules after production with a minimum purchased batch size of 400 vials of any Cell-in-a-Box®
product.
The Cannabis Licensing Agreement requires us
to make future royalty and milestone payments as follows:
| · | Ten percent royalty of the gross sale of all products sold by us; |
| · | Twenty percent royalty of the amount actually received by us from sub-licensees on sub-licensees’
gross sales value; and |
| · | Milestone payments of $100,000 within 30 days of beginning the first pre-clinical experiments using
the encapsulated cells; $500,000 within 30 days after enrollment of the first human patient in the first clinical trial; $800,000
within 30 days after enrollment of the first human patient in the first Phase 3 clinical trial; and $1,000,000 due 90 days after
having a NDA or a BLA approved by the FDA or a MAA approved in Europe or its equivalent based on the country in which it is accepted
for each product. |
The license under the Cannabis Licensing Agreement
may be terminated and all rights will revert to Austrianova if any of the following milestone events do not occur within the following
timeframes:
| · | If we do not enter into a research program involving the scope of the license within three years
of the effective date of the Diabetes Licensing Agreement; |
| · | If we do not enter into a clinical trial or its equivalent for a product within 7 years of the
effective date of the Diabetes Licensing Agreement; and |
| · | We do not pay the Upfront Payment of $2,000,000 in full by December 31, 2015. |
Sources and Availability of Raw Materials
The entire encapsulation process relating to
the encapsulation and the cells for the oncology and diabetes based treatment is to be carried out by Austrianova. It is responsible
for acquiring the necessary raw materials including the cellulose sulfate necessary for encapsulating the live cells. As mentioned
above, we have engaged ViruSure to clone new cells from a selected clone. Those clones will be grown to populate a MCB and WCB
for our future clinical trials.
Employees
As of April 30, 2015, we had four full-time
employees. We primarily use consulting scientists, physicians, academics and other professionals for the work in which we are engaged.
Available Information
Our Annual Reports on Form 10-K, Quarterly
Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports, as well as other documents we file with
the Commission, are available free of charge through the Investor Relations section of our web site (http://client.irwebkit.com/PharmaCyteBiotech)
as soon as reasonably practicable after such material is electronically filed with or furnished to the Commission. The public
can obtain documents that we file with the Commission at www.sec.gov. This Report includes trademarks, service marks and
trade names owned by us or other companies. All trademarks, service marks and trade names included in this Report are the property
of their respective owners.
ITEM 1A. RISK FACTORS (AS RESTATED)
You should carefully consider these
factors that may affect future results, together with all of the other information included in this Annual Report on Form 10-K/A,
in evaluating our business. The risks and uncertainties described below are those that we currently believe may materially
affect our business and results of operations. Additional risks and uncertainties that we are unaware of or that it currently
deems immaterial also may become important factors that affect its business and result of operations. Our shares of common
stock involve a high degree of risk and should be purchased only by investors who can afford a loss of their entire investment.
Prospective investors should carefully consider the following risk factors concerning our business before making an investment.
In addition, you should carefully
consider these risks when you read “forward-looking” statements elsewhere in this Report. These are statements that
relate to our expectations for future events and time periods. Generally, the words “anticipate”, “expect”,
“intend”, and similar expressions identify forward-looking statements. Forward-looking statements involve risks and
uncertainties, and future events and circumstances could differ significantly from those anticipated in the forward-looking statements.
Risks Related to Our Financial Position, Need for Additional
Capital and Overall Business
We Have a Short Operating
History, a Relatively New Business Model and Have Not Produced Any Revenues in Our Current Business Model. This makes it Difficult
to Evaluate Our Future Prospects and Increases the Risk that We Will Not be Successful.
We have a short operating history with
our current business model. Our current operations have produced no revenues and may not produce revenues in the near term
or at all, which may harm our ability to obtain additional financing and may require us to reduce or discontinue our operations. If
we create revenues in the future, we will derive most of such revenues from the sale of product candidates. You must consider
our business and prospects in light of the risks and difficulties we will encounter as an early-stage biotech company in a new
and rapidly evolving business sector. We may not be able to successfully address these risks and difficulties, which could
significantly harm our business, operating results and financial condition.
We Have a History of Losses
from Operations which May Continue and which May Harm Our Ability to Obtain Financing and Continue Our Operations.
Our operations are subject to the risks
and competition inherent in an early-stage biotech company. We may not generate sufficient revenues from operations to achieve
or sustain profitability in the future. Our revenues and profits, if any, will depend upon various factors, including whether
our existing products and services or any new products and services we develop will achieve any level of market acceptance. If
we continue to incur losses, our accumulated deficit will continue to increase which might significantly impair our ability to
obtain additional financing. As a result, our business, results of operations and financial condition would be significantly
harmed, and we may be required to reduce or terminate our operations.
We Are an Early Stage Company
and May Not Achieve Profitability.
We are an early stage, pre-revenue company.
An investor cannot readily determine if we will become profitable. We are likely to continue to experience financial difficulties
during this early revenue stage and beyond. We may be unable to operate profitably, even if we generate revenues. We may not obtain
the necessary working capital to continue developing and marketing our products. Furthermore, the present products may not receive
sufficient interest to generate revenues or achieve profitability.
We Need Additional Capital
to Continue Our Business Plans.
We will need additional capital to continue
our operations. There can be no assurance that we will obtain sufficient capital on acceptable terms, if at all. Failure to obtain
such capital would have an adverse impact on our financial position, operations and ability to continue as a going concern. Our
operating and capital requirements during the next fiscal year and thereafter will vary based on a number of factors, including
the level of sales and marketing activities for our products. There can be no assurance that additional private or public financing,
including debt or equity financing, will be available as needed or if available, on terms favorable to us. Additionally, any future
equity financing may be dilutive to stockholders’ present ownership levels and such additional equity securities may have
rights, preferences, or privileges that are senior to those of our existing common stock.
Furthermore, debt financing, if available,
may require payment of interest and potentially involve restrictive covenants that could impose limitations on our flexibility
to operate. Any difficulty or failure to successfully obtain additional funding may jeopardize our ability to continue the business
and our operations.
Our Entry into a Significant
Licensing Agreement Could Adversely Affect our Liquidity and our Ability to Execute our Research and Development Strategy.
On November 24, 2014, we entered into
the Cannabis Licensing Agreement. The use of our existing capital resources to make payments under the Cannabis Licensing Agreement
will accelerate our need for additional capital to continue our operations. Failure to obtain such capital or generate such operating
revenues would have an adverse impact on our financial position, operations and ability to continue as a going concern unless we
are able to extend the payment provisions of the Cannabis Licensing Agreement. The payment terms of the Cannabis Licensing Agreement
taken in conjunction with any difficulty or failure to successfully obtain additional funding may jeopardize our ability to continue
our business and operations.
Our Future Revenues are
Unpredictable Which Causes Potential Fluctuations in Operating Results.
As a result of our limited operating
history as a biotech company; we are currently unable to accurately forecast our revenues. Future expense levels will likely be
based largely on our marketing and development plans and estimates of future revenue. Any sales or operating results will likely
generally depend on volume and timing of orders and on our ability to fulfill such orders, both of which may not occur. We may
be unable to adjust spending in a timely manner to compensate for any unexpected revenue shortfall. Accordingly, any significant
shortfall in revenues in relation to planned expenditures could have an immediate adverse effect on our business, prospects, financial
condition and results of operations. Further, as a strategic response to changes in the competitive environment, we may from time
to time make certain pricing, service or marketing decisions that could have a material adverse effect on our business, prospects,
financial condition and results of operations.
We may experience significant fluctuations
in future operating results due to a variety of factors, many of which are outside of our control. Factors that may affect operating
results include: (i) ability to obtain and retain customers; (ii) attract new customers at a steady rate and maintain customer
satisfaction with products; (iii) the announcement or introduction of new products by us or our competitors; (iv) price
competition; (v) the level of use and consumer acceptance of its products; (vi) the amount and timing of operating costs and
capital expenditures relating to expansion of the business, operations and infrastructure; (vii) governmental regulations;
and (viii) general economic conditions.
We Face Substantial Competition,
Which May Result in Others Discovering, Developing or Commercializing Competing Products Before or More Successfully than We Do.
The development and commercialization
of new drug products is highly competitive. We face competition with respect to our current product candidates, and will face competition
with respect to any product candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies,
specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology
companies that currently market and sell products or are pursuing the development of products for the treatment of the disease
indications for which we are developing our product candidates. Some of these competitive products and therapies are based on scientific
approaches that are the same as or similar to our approach, and others are based on entirely different approaches. Potential competitors
also include academic institutions, government agencies and other public and private research organizations that conduct research,
seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.
Specifically, there are a large number
of companies developing or marketing treatments for cancer and diabetes, including many major pharmaceutical and biotechnology
companies. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that
are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products
that we may develop. Our competitors also may obtain regulatory approval for their products more rapidly than we may obtain approval
for ours, which could result in our competitors establishing a strong market position before we are able to enter the market and
or slow our regulatory approval.
Many of the companies against which
we are competing or against which we may compete in the future have significantly greater financial resources and expertise in
research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing
approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more
resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove
to be significant competitors, particularly through collaborative arrangements with large and established companies. These third
parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial
sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our
programs.
Development of Brand Awareness
is Critical to Our Success.
For certain market segments that we
plan to pursue, the development of our brand awareness is essential for us to reduce our marketing expenditures over time and realize
greater benefits from marketing expenditures. If our brand-marketing efforts are unsuccessful, growth prospects, financial condition
and results of operations would be adversely affected. Our brand awareness efforts have required, and will most likely continue
to require, additional expenses and time of the current senior management team.
Any Weakness in Our Internal
Controls Could Have a Material Adverse Effect on Us.
As discussed in “Item 9A-Controls
and Procedures,” the senior management has identified material weaknesses in our internal controls over financial reporting,
including those that resulted in the restatement of our consolidated financial statements included in this Amendment No. 1 to
our Annual Report on Form 10-K and cannot assure you that additional material weaknesses will not be identified in the future.
We cannot assure you that these steps will be successful in preventing material weaknesses or significant deficiencies in
our internal controls over financial reporting in the future. In addition, any such failure could adversely affect our ability
to report financial results on a timely and accurate basis, which could have other material effects on our business, reputation,
results of operations, financial condition or liquidity. Material weaknesses in internal controls over financial reporting or
disclosure controls and procedures could also cause investors to lose confidence in our reported financial information which could
have an adverse effect on the trading price of our securities.
Our Success Depends on Additional
States Legalizing Medical Cannabis.
Continued development of the medical
Cannabis market is dependent upon continued legislative authorization of Cannabis at the state level for medical purposes. Any
number of factors could slow or halt the progress. Further, progress, while encouraging, is not assured and the process normally
encounters set-backs before achieving success. While there may be ample public support for legislative proposal, key support must
be created in the legislative committee or a bill may never advance to a vote. Numerous factors impact the legislative process.
Any one of these factors could slow or halt the progress and adoption of Cannabis for medical purposes, which would limit the market
for our products and negatively impact our business.
The Alternative Medicine
Industry Faces Strong Opposition.
Certain well-funded and significant
businesses may have a strong economic opposition to the medical Cannabis industry. Lobbying by groups within the pharmaceutical
industry or changes in the regulation of Cannabis-based therapies could affect our ability to develop and market cannabinoid-based
cancer therapies.
Cannabis Remains Illegal
under Federal Law.
Cannabis remains illegal under federal
law. It is a Schedule 1 controlled substance. Even in those jurisdictions in which the use of medical Cannabis has been legalized
at the state level, its prescription is a violation of federal law. The United States Supreme Court has ruled in United States
v. Oakland Cannabis Buyers’ Coop. and Gonzales v. Raich that it is the federal government that has the right to
regulate and criminalize Cannabis, even for medical purposes. Therefore, federal law criminalizing the use of Cannabis trumps state
laws that legalize its use for medicinal purposes. The Obama administration has made a policy decision not to prosecute anyone
operating in accordance with applicable state law, but a new administration could introduce a less favorable policy. Changes in
federal policy could adversely affect our business.
The Insurance Coverage and
Reimbursement Status of Newly-Approved Products is Uncertain. Failure to Obtain or Maintain Adequate Coverage and Reimbursement
for New or Current Products Could Limit Our Ability to Market those Products and Decrease Our Ability to Generate Revenue.
The availability and extent of reimbursement
by governmental and private payors is essential for most patients to be able to afford expensive treatments. Sales of our product
candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates
will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed
by government health administration authorities, private health coverage insurers and other third-party payors. If reimbursement
is not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates.
Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing
sufficient to realize a sufficient return on our investment.
There is significant uncertainty related
to the insurance coverage and reimbursement of newly approved products. In the United States, the principal decisions about reimbursement
for new medicines are typically made by the Centers for Medicare & Medicaid Services (“CMS”), an agency within
the United States Department of Health and Human Services. CMS decides whether and to what extent a new medicine will be covered
and reimbursed under Medicare. Private payers tend to follow CMS to a substantial degree. It is difficult to predict what CMS will
decide with respect to reimbursement for fundamentally novel products such as ours, as there is no body of established practices
and precedents for these new products. Reimbursement agencies in the Europe may be more conservative than CMS. For example, a number
of cancer drugs have been approved for reimbursement in the United States and have not been approved for reimbursement in certain
European countries. Outside the United States, international operations are generally subject to extensive governmental price controls
and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in Europe, Canada and other
countries has and will continue to put pressure on the pricing and usage of our product candidates. In many countries, the prices
of medical products are subject to varying price control mechanisms as part of national health systems. In general, the prices
of medicines under such systems are substantially lower than in the United States. Other countries allow companies to fix their
own prices for medicines, but monitor and control company profits. Additional foreign price controls or other changes in pricing
regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the
United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate
commercially reasonable revenues and profits.
Moreover, increasing efforts by governmental
and third-party payors, in the United States and abroad, to cap or reduce healthcare costs may cause such organizations to limit
both coverage and level of reimbursement for new products approved and, as a result, they may not cover or provide adequate payment
for our product candidates. We expect to experience pricing pressures in connection with the sale of any of our product candidates,
due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative
changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other
treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products into
the healthcare market.
In addition to CMS and private payors,
professional organizations such as the National Comprehensive Cancer Network and the American Society of Clinical Oncology can
influence decisions about reimbursement for new medicines by determining standards for care. Many private payors may also contract
with commercial vendors who sell software that provide guidelines that attempt to limit utilization of, and therefore reimbursement
for, certain products deemed to provide limited benefit to existing alternatives. Such organizations may set guidelines that limit
reimbursement or utilization of our products.
Product Liability Lawsuits
against Us Could Cause Us to Incur Substantial Liabilities and to Limit Commercialization of any Products that We May Develop.
We face an inherent risk of product
liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk
if we commercially sell any products that we may develop. If we cannot successfully defend ourselves against claims that our product
candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability
claims may result in:
| · | Decreased demand for any product candidates or products that we may develop; |
| · | Injury to our reputation and significant negative media attention; |
| · | Withdrawal of clinical trial participants; |
| · | Significant costs to defend the related litigation; |
| · | Substantial monetary awards to trial participants or patients; |
| · | Reduced resources of our management to pursue our business strategy; and |
| · | The inability to commercialize any products that we may develop. |
We currently do not have product liability
insurance because we do not have any products to market. We will need such insurance as we commence our clinical trials or if we
commence commercialization of our product candidates. Insurance coverage is increasingly expensive. We may not be able to maintain
insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.
Risks Related to Regulatory Approval of Our Product
Candidates and Other Legal Compliance Matters
If We Are Unable to obtain,
or if there Are Delays in Obtaining, Required Approval from the Regulatory Agencies, We Will Not be Able to Commercialize Our Product
Candidates and Our Ability to Generate Revenue Will be Materially Impaired.
Our product candidates must be approved
by the Regulatory Agencies. The process of obtaining marketing approvals in the countries in which we intend to sell and distribute
our product candidates is expensive and takes many years, if approval is obtained at all. This process can vary substantially based
upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Failure to obtain marketing
approval for a product candidate will prevent us from commercializing that product candidate. We have not received approval to
market any of our product candidates from Regulatory Agencies in any jurisdiction. We have no experience in filing and supporting
the applications necessary to gain marketing approvals and expect to rely on third-party CROs to assist us in this process. Securing
marketing approval requires the submission of extensive preclinical and clinical data and supporting information to the Regulatory
Agencies for each product candidate to establish the product candidate’s safety and efficacy. Securing marketing approval
also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities
by, the Regulatory Agencies.
Our product candidates may not be effective,
may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics
that may preclude our obtaining marketing approval or prevent or limit commercial use. Regulatory Agencies have substantial discretion
in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and
require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical
and clinical testing could delay, limit or prevent marketing approval of a product candidate. Changes in marketing approval policies
during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review
for each submitted product application, may also cause delays in or prevent the approval of an application. New cancer drugs frequently
are indicated only for patient populations that have not responded to an existing therapy or have relapsed. If we experience delays
in obtaining approval or if we fail to obtain approval of our product candidates, the commercial prospects for our product candidates
may be harmed and our ability to generate revenues will be materially impaired.
Clinical Drug Development
Involves a Lengthy and Expensive Process with an Uncertain Outcome. We May Incur Additional Costs or Experience Delays in Completing
or be Unable to Complete the Development and Commercialization of Our Product Candidates.
Our Cell-in-a-Box® and
ifosfamide product candidate is in mid-stage clinical development, and the risk of its failure is high. It is impossible to predict
when or if this product candidate or any other product candidate will prove effective or safe in humans or will receive regulatory
approval. Before obtaining marketing approval from Regulatory Agencies for the sale of any product candidate, we must complete
preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates
in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as
to outcome. A failure of one or more clinical trials can occur at any stage of testing. The clinical development of our product
candidates is susceptible to the risk of failure inherent at any stage of drug development, including failure to demonstrate efficacy
in a clinical trial or across a broad population of patients, the occurrence of severe or medically or commercially unacceptable
adverse events, failure to comply with protocols or applicable regulatory requirements and determination by the Regulatory Agencies
that a drug product is not approvable. It is possible that even if one or more of our product candidates has a beneficial effect,
that effect will not be detected during clinical evaluation as a result of one or more of a variety of factors, including the size,
duration, design, measurements, conduct or analysis of our clinical trials. Conversely, as a result of the same factors, our clinical
trials may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if any.
Similarly, in our clinical trials we may fail to detect toxicity of or intolerability caused by our product candidates, or mistakenly
believe that our product candidates are toxic or not well tolerated when that is not in fact the case.
The outcome of preclinical studies and
early and mid-phase clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical
trial do not necessarily predict final results. Many companies in the pharmaceutical and biotechnology industries have suffered
significant setbacks in late-stage clinical trials after achieving positive results in earlier development, and we cannot be certain
that we will not face additional setbacks.
The design of a clinical trial can determine
whether its results will support approval of a product; however, flaws in the design of a clinical trial may not become apparent
until the clinical trial is well advanced or completed. We have limited experience in designing clinical trials and may be unable
to design and execute a clinical trial to support marketing approval. In addition, preclinical and clinical data are often susceptible
to varying interpretations and analyses. Many companies that believed their product candidates performed satisfactorily in preclinical
studies and clinical trials have nonetheless failed to obtain marketing approval for the product candidates. Even if we believe
that the results of clinical trials for our product candidates warrant marketing approval, the Regulatory Agencies may disagree
and may not grant marketing approval of our product candidates.
In some instances, there can be significant
variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors,
including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes
in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants. Any Phase 1, Phase
2, Phase 3 or other clinical trials that we may conduct may not demonstrate the efficacy and safety necessary to obtain regulatory
approval to market our product candidates.
We Intend to Conduct Clinical
Trials for Certain of Our Product Candidates at Sites Outside of the United States, and the United States Regulatory Agencies May
Not Accept Data from Trials Conducted in Such Locations.
We intend to conduct one or more of
our clinical trials outside of the United States. Although the FDA may accept data from clinical trials conducted outside the United
States, acceptance of this data is subject to certain conditions imposed by the Regulatory Agencies outside of the United States.
For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with
ethical principles. The trial population must also adequately represent the population in the country in which the clinical trial
is being conducted. The data must be applicable to the United States population and medical practice in the United States in ways
that the FDA deems clinically meaningful. Generally, the patient population for any clinical trials conducted outside of the United
States must be representative of the population for whom we intend to seek approval in the United States. In addition, while these
clinical trials are subject to the applicable local laws, FDA acceptance of the data will be dependent upon its determination that
the trials also complied with all applicable United States laws and regulations. There can be no assurance that the FDA will accept
data from trials conducted outside of the United States. If the FDA does not accept the data from any of our clinical trials that
we determine to conduct outside the United States, it would likely result in the need for additional trials that would be costly
and time-consuming and delay or permanently halt our development of the product candidate.
In addition, the conduct of clinical
trials outside the United States could have a significant impact on us. Risks inherent in conducting international clinical trials
include:
| · | Foreign regulatory requirements that could restrict or limit our ability to conduct our clinical
trials; |
| · | Administrative burdens of conducting clinical trials under multiple foreign regulatory schema; |
| · | Foreign exchange fluctuations; and |
| · | Diminished protection of intellectual property in some countries. |
If Clinical Trials of Our
Product Candidates Fail to Demonstrate Safety and Efficacy to the Satisfaction of the Regulatory Agencies, We May Incur Additional
Costs or Experience Delays in Completing or be Unable to Complete the Development and Commercialization of These Product Candidates.
We are not permitted to commercialize,
market, promote or sell any product candidate in the United States without obtaining marketing approval from the FDA. Comparable
Regulatory Agencies outside of the United States, such as the EMA, impose similar restrictions. We may never receive such approvals.
We must complete extensive preclinical development and clinical trials to demonstrate the safety and efficacy of our product candidates
in humans before we will be able to obtain these approvals.
Clinical testing is expensive, difficult
to design and implement, can take many years to complete and is inherently uncertain as to outcome. We have not previously submitted
a NDA, a BLA or a MAA to Regulatory Agencies for any of our product candidates.
Any inability to successfully complete
preclinical and clinical development could result in additional costs to us and impair our ability to generate revenues from product
sales, regulatory and commercialization milestones and royalties. In addition, if: (i) we are required to conduct additional clinical
trials or other testing of our product candidates beyond the trials and testing that we contemplate; (ii) we are unable to successfully
complete clinical trials of our product candidates or other testing; (iii) the results of these trials or tests are unfavorable,
uncertain or are only modestly favorable; or (iv) there are unacceptable safety concerns associated with our product candidates,
we, in addition to incurring additional costs, may:
| · | Be delayed in obtaining marketing approval for our product candidates; |
| · | Not obtain marketing approval at all; |
| · | Obtain approval for indications or patient populations that are not as broad as we intended or
desired; |
| · | Obtain approval with labeling that includes significant use or distribution restrictions or significant
safety warnings, including boxed warnings; |
| · | Be subject to additional post-marketing testing or other requirements; or |
| · | Be required to remove the product from the market after obtaining marketing approval. |
If We Experience any of
a Number of Possible Unforeseen Events in Connection with Clinical Trials of Our Product Candidates, Potential Marketing Approval
or Commercialization of our Product Candidates Could be Delayed or Prevented.
We may experience numerous unforeseen
events during, or as a result of, clinical trials that could delay or prevent marketing approval of our product candidates, including:
| · | Clinical trials of our product candidates may produce unfavorable or inconclusive results; |
| · | We may decide, or regulators may require us, to conduct additional clinical trials or abandon product
development programs or candidates; |
| · | The number of patients required for clinical trials of our product candidates may be larger than
we anticipate, patient enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these
clinical trials at a higher rate than we anticipate; |
| · | Our third party contractors, including those manufacturing our product candidates or components
or ingredients thereof or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their
contractual obligations to us in a timely manner or at all; |
| · | Regulators or institutional review boards may not authorize us or our investigators to commence
a clinical trial or conduct a clinical trial at a prospective trial site; |
| · | We may experience delays in reaching or failing to reach agreement on acceptable clinical trial
contracts or clinical trial protocols with prospective trial sites; |
| · | Patients who enroll in a clinical trial may misrepresent their eligibility to do so or may otherwise
not comply with the clinical trial protocol, resulting in the need to drop the patients from the clinical trial, increase the needed
enrollment size for the clinical trial or extend the clinical trial’s duration; |
| · | We may have to suspend or terminate clinical trials of our product candidates for various reasons,
including a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected
characteristics of a product candidate; |
| · | Regulatory Agencies or institutional review boards may require that we or our investigators suspend
or terminate clinical research for various reasons, including noncompliance with regulatory requirements or their respective standards
of conduct, a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected
characteristics of the product candidate or findings of undesirable effects caused by a chemically or mechanistically similar drug
or drug candidate; |
| · | Regulatory Agencies may disagree with our clinical trial design or our interpretation of data from
preclinical studies and clinical trials; |
| · | Regulatory Agencies may fail to approve or subsequently find fault with the manufacturing processes
or facilities of third party manufacturers with which we enter into agreements for clinical and commercial supplies; |
| · | The supply or quality of raw materials or manufactured product candidates or other materials necessary
to conduct clinical trials of our product candidates may be insufficient, inadequate, delayed, or not available at an acceptable
cost, or we may experience interruptions in supply; and |
| · | The approval policies or regulations of the Regulatory Agencies may significantly change in a manner
rendering our clinical data insufficient to obtain marketing approval. |
Product development costs for us will increase
if we experience delays in testing or pursuing marketing approvals and we may be required to obtain additional funds to complete
clinical trials and prepare for possible commercialization of our product candidates. We do not know whether any preclinical studies
or clinical trials will begin as planned, will need to be restructured or will be completed on schedule or at all. Significant
preclinical study or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize
our product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully
commercialize our product candidates and may harm our business and results of operations. In addition, many of the factors that
cause, or lead to, clinical trial delays may ultimately lead to the denial of marketing approval of any of our product candidates.
If We Experience Delays or Difficulties
in the Enrollment of Patients in Clinical Trials, We May Not Achieve Our Clinical Development Timeline and our Receipt of Necessary
Regulatory Approvals Could be Delayed or Prevented.
We may not be able to initiate or continue
clinical trials for our encapsulated live cell/ifosfamide product or any other product candidates if we are unable to locate and
enroll a sufficient number of eligible patients to participate in clinical trials. Patient enrollment is a significant factor in
the timing of clinical trials, and is affected by many factors, including:
| · | The size and nature of the patient population; |
| · | The severity of the disease under investigation; |
| · | The proximity of patients to clinical sites; |
| · | The eligibility criteria for the trial; |
| · | The design of the clinical trial; |
| · | Efforts to facilitate timely enrollment; |
| · | Competing clinical trials; and |
| · | Clinicians’ and patients’ perceptions as to the potential advantages and risks of the
drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we
are investigating. |
Our inability to enroll a sufficient number
of patients for our clinical trials could result in significant delays or may require us to abandon one or more clinical trials
altogether. Enrollment delays in our clinical trials may result in increased development costs for our product candidates, delay
or halt the development of and approval processes for our product candidates and jeopardize our ability to achieve our clinical
development timeline and goals, including the dates by which we will commence, complete and receive results from clinical trials.
Enrollment delays may also delay or jeopardize our ability to commence sales and generate revenues from our product candidates.
Any of the foregoing could cause the value of our company to decline and limit our ability to obtain additional financing, if needed.
Positive Results in Previous Clinical
Trials of Our Encapsulated Live Cell and Ifosfamide May Not be Replicated in Future Clinical Trials Which Could Result in Development
Delays or a Failure to Obtain Marketing Approval.
Positive results in the previous Phase 1/2
and Phase 2 clinical trials of the encapsulated live cell and ifosfamide combination may not be predictive of similar results in
future clinical trials. Also, interim results during a clinical trial do not necessarily predict final results. A number of companies
in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after
achieving promising results in early-stage development. Our clinical trials may produce negative or inconclusive results and we
may decide, or Regulatory Agencies may require us, to conduct additional clinical trials. Moreover, clinical data are often susceptible
to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in
preclinical studies and clinical trials have nonetheless failed to obtain the approval for their products by the Regulatory Agencies.
We May Request Priority Review
for Our Product Candidates in the Future. The Regulatory Agencies May Not Grant Priority Review for any of Our Product Candidates.
Moreover, even if the Regulatory Agencies Designated such Products for Priority Review, that Designation May Not Lead to a Faster
Regulatory Review or Approval Process and, in any Event, Would Not Assure Approval by the Regulatory Agencies.
We may be eligible for priority review designation
for our product candidates if the Regulatory Agencies determine such product candidates offer major advances in treatment or provide
a treatment where no adequate therapy exists. A priority review designation means that the time required for the Regulatory Agencies
to review an application is less than the standard review period. The Regulatory Agencies have broad discretion with respect to
whether or not to grant priority review status to a product candidate, so even if we believe a particular product candidate is
eligible for such designation or status, the Regulatory Agencies may decide not to grant it. Thus, while the Regulatory Agencies
have granted priority review to other oncology and diabetes products, our product candidates, should we determine to seek priority
review of them, may not receive similar designation. Moreover, even if one of our product candidates is designated for priority
review, such a designation does not necessarily mean a faster regulatory review process or necessarily confer any advantage with
respect to approval compared to conventional procedures of the Regulatory Agencies. Receiving priority review from the Regulatory
Agencies does not guarantee approval within an accelerated timeline or thereafter.
In Some Instances We Believe We
May be Able to Secure Approval from the Regulatory Agencies to Use Accelerated Development Pathways. If We Are Unable to Obtain
such Approval, We May be Required to Conduct Additional Preclinical Studies or Clinical Trials Beyond Those That We Contemplate
Which Could Increase the Expense of Obtaining and Delay the Receipt of Necessary Marketing Approvals.
We anticipate that we may seek an accelerated
approval pathway for certain of our product candidates. Under the accelerated approval provisions or their implementing regulations
of the Regulatory Agencies, they may grant accelerated approval to a product designed to treat a serious or life-threatening condition
that provides meaningful therapeutic benefit over available therapies upon a determination that the product has an effect on a
surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The Regulatory Agencies
consider a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease,
such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as
a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is
not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier
than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity
or mortality or other clinical benefit. The accelerated approval pathway may be used in cases in which the advantage of a new drug
over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and
public health perspective. If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct,
in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit. If
such post-approval studies fail to confirm the drug’s clinical benefit, the Regulatory Agencies may withdraw their approval
of the drug.
Prior to seeking such accelerated approval,
we will seek feedback from the Regulatory Agencies and will otherwise evaluate our ability to seek and receive such accelerated
approval. There can also be no assurance that after our evaluation of the feedback and other factors we will decide to pursue or
submit a NDA, a BLA or a MAA for accelerated approval or any other form of expedited development, review or approval. Similarly,
there can be no assurance that after subsequent feedback from the Regulatory Agencies that we will continue to pursue or apply
for accelerated approval or any other form of expedited development, review or approval, even if we initially decide to do so.
Furthermore, if we decide to submit an application for accelerated approval or under another expedited regulatory designation (such
as the breakthrough therapy designation), there can be no assurance that such submission or application will be accepted or that
any expedited development, review or approval will be granted on a timely basis or at all. The Regulatory Agencies could also require
us to conduct further studies prior to considering our application or granting approval of any type. A failure to obtain accelerated
approval or any other form of expedited development, review or approval for any of our product candidates that we determine to
seek accelerated approval for would result in a longer time period to commercialization of such product candidate, could increase
the cost of development of such product candidate and could harm our competitive position in the marketplace.
We May Seek Orphan Drug Exclusivity
for Some of Our Product Candidates, and We May be Unsuccessful.
Regulatory Agencies may designate drugs for
relatively small patient populations as orphan drugs. Under the standards and requirements of the Regulatory Agencies, they may
designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition. In the United States, this
is generally defined as a disease with a patient population of fewer than 200,000 individuals. If a product with an Orphan Drug
Designation subsequently receives the first marketing approval for the indication for which it has such designation, the product
is entitled to a period of marketing exclusivity, which precludes the EMA or FDA from approving another marketing application for
the same drug for the same indication during the period of exclusivity. The applicable period is seven years in the United States
and ten years in Europe. The European exclusivity period can be reduced to six years if a drug no longer meets the criteria for
Orphan Drug Designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified.
Orphan Drug Exclusivity may be lost if the
Regulatory Agencies determine that the request for designation was materially defective or if the manufacturer is unable to assure
sufficient quantity of the drug to meet the needs of patients with the rare disease or condition. Even if we obtain Orphan Drug
exclusivity for a product candidate, that exclusivity may not effectively protect the product candidate from competition because
different drugs can be approved for the same condition. Even after an orphan drug is approved, the Regulatory Agencies can subsequently
approve a different drug for the same condition if they conclude that the later drug is clinically superior in that it is shown
to be safer, more effective or makes a major contribution to patient care.
A Fast Track Designation by the
Regulatory Agencies, even if Granted for any of the Our Product Candidates, May Not Lead to a Faster Development or Regulatory
Review or Approval Process and Does Not Increase the Likelihood that Our Product Candidates Will Receive Marketing Approval.
We do not currently have Fast Track designation
for any of our product candidates but intend to seek such designation. If a drug is intended for the treatment of a serious or
life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug
sponsor may apply for Fast Track designation. The Regulatory Agencies have broad discretion whether or not to grant this designation.
Even if we believe a particular product candidate is eligible for this designation, we cannot assure you that the Regulatory Agencies
would decide to grant it. Even if we do receive Fast Track designation, we may not experience a faster development process, review
or approval compared to conventional procedures adopted by the Regulatory Agencies. In addition, the Regulatory Agencies may withdraw
Fast Track designation if they believe that the designation is no longer supported by data from our clinical development program.
Many drugs that have received Fast Track designation have failed to obtain drug approval.
A Breakthrough Therapy Designation
by the Regulatory Agencies, even if Granted for any of Our Product Candidates, May Not Lead to a Faster Development or Regulatory
Review or Approval Process and Does Not Increase the Likelihood that Our Product Candidates Will Receive Marketing Approval.
We do not currently have Breakthrough Therapy
designation for any of our product candidates but may seek such designation. A “Breakthrough Therapy” is defined as
a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or
condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies
on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
For drugs that have been designated as Breakthrough Therapies, interaction and communication between the Regulatory Agencies and
the sponsor can help to identify the most efficient path for development.
Designation as a Breakthrough Therapy is within
the discretion of the Regulatory Agencies. Accordingly, even if we believe, after completing early clinical trials, that one of
our product candidates meets the criteria for designation as a Breakthrough Therapy, the Regulatory Agencies may disagree and instead
determine not to make such designation. In any event, the receipt of a Breakthrough Therapy designation for a product candidate
may not result in a faster development process, review or approval compared to drugs considered for approval under conventional
procedures of the Regulatory Agencies and does not assure their ultimate approval. In addition, even if one or more of our product
candidates qualify as Breakthrough Therapies, the Regulatory Agencies may later decide that such product candidates no longer meet
the conditions for qualification.
Failure to Obtain Marketing Approval
in International Jurisdictions Would Prevent Our Product Candidates from being Marketed Abroad.
In order to market and sell our products in
Europe and many other jurisdictions outside the United States, we or our third-party collaborators must obtain separate marketing
approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve
additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The
regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval.
In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before
the product can be approved for sale in that country. We or these third parties may not obtain approvals from Regulatory Agencies
outside the United States on a timely basis, if at all. Approval by FDA does not ensure approval by Regulatory Agencies in other
countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by Regulatory
Agencies in other countries or jurisdictions or by FDA. We may not be able to file for marketing approvals and may not receive
necessary approvals to commercialize our products in any market.
Any Product Candidate for Which
We Obtain Marketing Approval Will be Subject to Extensive Post-Marketing Regulatory Requirements and Could be Subject to Post-Marketing
Restrictions or Withdrawal from the Market. We May be Subject to Penalties if We Fail to Comply with Regulatory Requirements or
if We Experience Unanticipated Problems with Our Products, when and if any of Our Product Candidates Are Approved.
Our product candidates and the activities associated
with their development and commercialization, including their testing, manufacture, recordkeeping, labeling, storage, approval,
advertising, promotion, sale and distribution, are subject to comprehensive regulation by the Regulatory Agencies. These requirements
include submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements
relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, including
periodic inspections by the Regulatory Agencies, requirements regarding the distribution of samples to physicians and recordkeeping.
In addition, the Regulatory Agencies may impose
requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of a product
candidate. The Regulatory Agencies closely regulate the post-approval marketing and promotion of drugs to ensure drugs are marketed
only for the approved indications and in accordance with the provisions of the approved labeling. They also impose stringent restrictions
on manufacturers’ communications regarding use of their products. If we promote our products beyond their approved indications,
we may be subject to enforcement action for off-label promotion. Violations of the laws relating to the promotion of prescription
drugs may lead to investigations alleging violations of federal and state healthcare fraud and abuse laws, as well as state consumer
protection laws.
Also, later discovery of previously unknown
adverse events or other problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory
requirements, may yield various results, including:
| · | Restrictions on such products, manufacturers or manufacturing processes; |
| · | Restrictions on the labeling or marketing of a product; |
| · | Restrictions on product distribution or use; |
| · | Requirements to conduct post-marketing studies or clinical trials; |
| · | Warning or untitled letters; |
| · | Withdrawal of the products from the market; |
| · | Refusal to approve pending applications or supplements to approved applications that we submit; |
| · | Fines, restitution or disgorgement of profits or revenues; |
| · | Suspension or withdrawal of marketing approvals; |
| · | Refusal to permit the import or export of our products; |
| · | Injunctions or the imposition of civil or criminal penalties. |
Non-compliance with European requirements regarding
safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population,
can also result in significant financial penalties. Similarly, failure to comply with the Europe’s requirements regarding
the protection of personal information can also lead to significant penalties and sanctions.
Our Relationships with Customers
and Third-Party Payors Will be Subject to Applicable Anti-Kickback, Fraud and Abuse and other Healthcare Laws and Regulations,
Which Could Expose Us to Criminal Sanctions, Civil Penalties, Contractual Damages, Reputational Harm and Diminished Profits and
Future Earnings.
Healthcare providers, physicians and third-party
payors will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing
approval. Our future arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and
other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which
we market, sell and distribute any products for which we obtain marketing approval. Restrictions under applicable healthcare laws
and regulations include the following:
| · | The Federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully
soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or
in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for
which payment may be made under a federal healthcare program such as Medicare and Medicaid; |
| · | The Federal False Claims Act imposes criminal and civil penalties, including civil whistleblower
or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal
government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation
to pay money to the Federal governments; and |
| · | The Federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) imposes
criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating
to healthcare matters. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing
regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security
and transmission of individually identifiable health information. Federal law requires applicable manufacturers of covered drugs
to report payments and other transfers of value to physicians and teaching hospitals, which includes data collection and reporting
obligations. The information is to be made publicly available on a searchable website in September 2014. Analogous state and foreign
laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims
involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. |
Some state laws require pharmaceutical companies
to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated
by the federal government and may require drug manufacturers to report information related to payments and other transfers of value
to physicians and other healthcare providers or marketing expenditures. State and foreign laws also govern the privacy and security
of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted
by HIPAA, thus complicating compliance efforts.
Efforts to ensure that our business arrangements
with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that
governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations
or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in
violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil,
criminal and administrative penalties, damages, fines, imprisonment, exclusion of products from government funded healthcare programs,
such as Medicare and Medicaid, and the curtailment or restructuring of our operations. If any of the physicians or other healthcare
providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject
to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.
Recently Enacted and Future Legislation
Could Increase the Difficulty and Cost for Us to Obtain Marketing Approval of and Commercialize Our Product Candidates and Affect
the Prices We May Obtain.
In the United States and some foreign jurisdictions,
there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could
prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability
to profitably sell any product candidates for which we obtain marketing approval.
In the United States, the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (“MMA”) changed the way Medicare covers and pays for pharmaceutical
products. The legislation expanded Medicare coverage for drug purchases by the elderly and introduced a new reimbursement methodology
based on average sales prices for physician-administered drugs. In addition, this legislation provided authority for limiting the
number of drugs that will be covered in any therapeutic class. Cost reduction initiatives and other provisions of this legislation
could decrease the coverage and price that we receive for any approved products. While the MMA only applies to drug benefits for
Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement
rates. Therefore, any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private
payors.
In March 2010, President Obama signed into
law the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act
(collectively, “PPACA”), a sweeping law intended to broaden access to health insurance, reduce or constrain the growth
of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for the healthcare and health
insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms. Among the provisions
of the PPACA of importance to our potential product candidates are the following:
| · | An annual, nondeductible fee on any entity that manufactures or imports specified branded prescription
drugs and biologic agents; |
| · | An increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate
Program; |
| · | Expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback
Statute, new government investigative powers and enhanced penalties for noncompliance; |
| · | A new Medicare Part D coverage gap discount program in which manufacturers must agree to offer
50% point-of-sale discounts off negotiated prices; |
| · | Extension of manufacturers’ Medicaid rebate liability; |
| · | Expansion of eligibility criteria for Medicaid programs; |
| · | Expansion of the entities eligible for discounts under the Public Health Service pharmaceutical
pricing program; |
| · | New requirements to report financial arrangements with physicians and teaching hospitals; |
| · | A new requirement to annually report drug samples that manufacturers and distributors provide to
physicians; and |
| · | A new Patient-Centered Outcomes Research Institute to oversee, identify priorities in and conduct
comparative clinical effectiveness research, along with funding for such research. |
In addition, other legislative changes have
been proposed and adopted since the PPACA was enacted. These changes included aggregate reductions to Medicare payments to providers
of up to 2% per fiscal year, starting in 2013. In January 2013, President Obama signed into law the American Taxpayer Relief Act
of 2012, which, among other things, reduced Medicare payments to several providers and increased the statute of limitations period
for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions
in Medicare and other healthcare funding.
We expect that the PPACA, as well as other
healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward
pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government
programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or
other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our product
candidates.
Legislative and regulatory proposals have been
made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot
be sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretations will be
changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition,
increased scrutiny by the United States Congress of FDA’s approval process may significantly delay or prevent marketing approval
in the United States, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.
Governments outside the United
States Tend to Impose Strict Price Controls, which may Adversely Affect Our Revenues, if any.
In some countries, particularly the countries
of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing
negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To
obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness
of our product candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount,
or if pricing is set at unsatisfactory levels, our business could be materially harmed.
Risks Related to the Commercialization of Our Product Candidates
Serious Adverse Events or Undesirable
Side Effects or Other Unexpected Properties of Our Encapsulated Live Cell plus Ifosfamide Product Candidate or any of Our other
Product Candidates May be Identified During Development that Could Delay or Prevent the Product Candidates’ Marketing Approval.
Serious adverse events or undesirable side
effects caused by, or other unexpected properties of, our product candidates could cause us, an institutional review board or Regulatory
Agencies to interrupt, delay or halt clinical trials of one or more of our product candidates and could result in a more restrictive
label or the delay or denial of marketing approval by the Regulatory Agencies. If any of our product candidates is associated with
serious adverse events or undesirable side effects or has properties that are unexpected, we may need to abandon development or
limit development of that product candidate to certain uses or subpopulations in which the undesirable side effects or other characteristics
are less prevalent, less severe or more acceptable from a risk-benefit perspective. Many compounds that initially showed promise
in clinical or earlier stage testing have later been found to cause undesirable or unexpected side effects that prevented further
development of the compound.
Even if One of Our Product Candidates
Receives Marketing Approval, it May Fail to Achieve the Degree of Market Acceptance by Physicians, Patients, Third Party Payors
and Others in the Medical Community Necessary for Commercial Success and the Market Opportunity for the Product Candidate May be
Smaller than We.
We have never commercialized a drug product.
Even if our encapsulated live cell plus ifosfamide product candidate or any of our other product candidates is approved by the
one or more of the Regulatory Agencies for marketing and sale, it may nonetheless fail to gain sufficient market acceptance by
physicians, patients, third party payors and others in the medical community. For example, physicians are often reluctant to switch
their patients from existing therapies even when new and potentially more effective or convenient treatments enter the market.
Further, patients often acclimate to the therapy that they are currently taking and do not want to switch unless their physicians
recommend switching products or they are required to switch therapies due to lack of reimbursement for existing therapies.
Efforts to educate the medical community and
third party payors on the benefits of our product candidates may require significant resources and may not be successful. If any
of our product candidates is approved but does not achieve an adequate level of market acceptance, we may not generate significant
revenues and we may not become profitable.
| · | The degree of market acceptance of our encapsulated live cell plus ifosfamide product candidate
or any of our other product candidates, if approved for commercial sale, will depend on a number of factors, including: |
| · | The efficacy and safety of the product; |
| · | The potential advantages of the product compared to alternative treatments; |
| · | The prevalence and severity of any side effects; |
| · | The clinical indications for which the product is approved; |
| · | Whether the product is designated under physician treatment guidelines as a first-line therapy
or as a second- or third-line therapy; |
| · | Limitations or warnings, including distribution or use restrictions, contained in the product’s
approved labeling; |
| · | Our ability to offer the product for sale at competitive prices; |
| · | Our ability to establish and maintain pricing sufficient to realize a meaningful return on our
investment; |
| · | The product’s convenience and ease of administration compared to alternative treatments; |
| · | The willingness of the target patient population to try, and of physicians to prescribe, the product; |
| · | The strength of sales, marketing and distribution support; |
| · | The approval of other new products for the same indications; |
| · | Changes in the standard of care for the targeted indications for the product; |
| · | The timing of market introduction of our approved products as well as competitive products and
other therapies; |
| · | Availability and amount of reimbursement from government payors, managed care plans and other third
party payers; |
| · | Adverse publicity about the product or favorable publicity about competitive products; and |
| · | Potential product liability claims. |
The potential market opportunities for our
product candidates are difficult to estimate precisely. Our estimates of the potential market opportunities are predicated on many
assumptions, including industry knowledge and publications, third party research reports and other surveys. While we believe that
our internal assumptions are reasonable, these assumptions involve the exercise of significant judgment on the part of our management,
are inherently uncertain and the reasonableness of these assumptions has not been assessed by an independent source. If any of
the assumptions proves to be inaccurate, the actual markets for our product candidates could be smaller than our estimates of the
potential market opportunities.
If any of Our Product Candidates
Receives Marketing Approval and We or Others Later Discover that the Drug is Less Effective than Previously Believed or Causes
Undesirable Side Effects that Were Not Previously Identified, Our Ability to Market the Drug Could be Compromised.
Clinical trials of our product candidates are
conducted in carefully defined subsets of patients who have agreed to enter into clinical trials. Consequently, it is possible
that our clinical trials may indicate an apparent positive effect of a product candidate that is greater than the actual positive
effect, if any, or alternatively fail to identify undesirable side effects. If, following approval of a product candidate, we or
others discover that the product candidate is less effective than previously believed or causes undesirable side effects that were
not previously identified, any of the following adverse events could occur:
| · | Regulatory Agencies may withdraw their approval of the product candidate or seize the product candidate; |
| · | We may be required to recall the product candidate or change the way the product is administered; |
| · | Additional restrictions may be imposed on the marketing of, or the manufacturing processes for,
the particular product candidate; |
| · | We may be subject to fines, injunctions or the imposition of civil or criminal penalties; |
| · | Regulatory Agencies may require the addition of labeling statements, such as a “black box”
warning or a contraindication; |
| · | We may be required to create a Medication Guide outlining the risks of the previously unidentified
side effects for distribution of our product candidate to patients; |
| · | We could be sued and held liable for harm caused to patients; |
| · | The product candidate may become less competitive; and |
| · | Our reputation may suffer. |
Any of these events could have a material and adverse effect on
our operations and business and could adversely impact our stock price.
If We Are Unable to Establish Sales,
Marketing and Distribution Capabilities or Enter into Acceptable Sales, Marketing and Distribution Arrangements with Third Parties,
We May Not be Successful in Commercializing any Product Candidate that We Develop if and when a Product Candidate is Approved.
We do not have a sales, marketing or distribution
infrastructure and have no experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial
success for any approved product candidate, we must either develop a sales and marketing organization, outsource these functions
to third parties or license our product candidates to others. If approved, we expect to license our encapsulated live cell plus
ifosfamide product candidate to a large pharmaceutical company with greater resources and experience than us.
We may not be able license our encapsulated
live cell plus ifosfamide product candidate on reasonable terms, if at all. If other product candidates are approved for smaller
or easily targeted markets, we expect to commercialize them in the United States directly with a small and highly focused commercialization
organization. The development of sales, marketing and distribution capabilities will require substantial resources and will be
time-consuming, which could delay any product candidate launch.
We expect that we will commence the development
of these capabilities prior to receiving approval of any of our product candidates. If the commercial launch of a product candidate
for which we recruit a sales force and establish marketing and distribution capabilities is delayed or does not occur for any reason,
we could have prematurely or unnecessarily incurred these commercialization costs. Such a delay may be costly, and our investment
could be lost if we cannot retain or reposition our sales and marketing personnel.
In addition, we may not be able to hire or
retain a sales force in the United States that is sufficient in size or has adequate expertise in the medical markets that we plan
to target. If we are unable to establish or retain a sales force and marketing and distribution capabilities, our operating results
may be adversely affected. If a potential partner has development or commercialization expertise that we believe is particularly
relevant to one of our product candidates, then we may seek to collaborate with that potential partner even if we believe we could
otherwise develop and commercialize the product candidate independently.
We expect to seek one or more strategic partners
for commercialization of our product candidates outside the United States. As a result of entering into arrangements with third
parties to perform sales, marketing and distribution services, our product revenues or the profitability of these product revenues
may be lower, perhaps substantially lower, than if we were to directly market and sell products in those markets. Furthermore,
we may be unsuccessful in entering into the necessary arrangements with third parties or may be unable to do so on terms that are
favorable to us. In addition, we may have little or no control over such third parties and any of them may fail to devote the necessary
resources and attention to sell and market our product candidates effectively.
If we do not establish sales and marketing
capabilities, either on our own or in collaboration with third parties, we will not be successful in commercializing any of our
product candidates that receive marketing approval.
Risks Related to Our Dependence on Third Parties
We Rely and Expect to Continue
to Rely Heavily on Third Parties to Conduct Our Preclinical Studies and Clinical Trials, and Those Third Parties May Not Perform
Satisfactorily, Including Failing to Meet Deadlines for the Completion of Such Studies and Trials.
We currently rely on third party CROs to conduct
our clinical trials. We expect to continue to rely heavily on third parties, such as CROs, clinical data management organizations,
medical institutions and clinical investigators and others to conduct our clinical trials. Our agreements with these third parties
generally allow the third party to terminate our agreement with them at any time. If we are required to enter into alternative
arrangements because of any such termination, the introduction of our product candidates to market could be delayed.
Our reliance on these third parties for research
and development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example,
we design our clinical trials and will remain responsible for ensuring that each of our clinical trials is conducted in accordance
with the general investigational plan and protocols for the trial. Moreover, the Regulatory Agencies require us to comply with
current cGCP standards for conducting, recording and reporting the results of clinical trials to assure that data and reported
results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance
on third parties that we do not control does not relieve us of these responsibilities and requirements. We also are required to
register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database of the Regulatory
Agencies within specified timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.
Furthermore, these third parties may also have
relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their
contractual duties, meet expected deadlines or conduct our clinical trials in accordance with the requirements of the Regulatory
Agencies or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product
candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.
We Expect to Rely on Third Parties
to Store and Distribute our Product Candidates for Our Clinical Trials. Any Performance Failure on the Part of such Third Parties
Could Delay Clinical Development or Marketing Approval of Our Product Candidates or Commercialization of Our Products, Producing
Additional Losses and Depriving Us of Potential Product Candidate Revenue. Our Existing Collaboration with the Universities and
Institutions is Important to Our Business. If We Are Unable to Maintain this Collaboration, or if this Collaboration is Not Successful,
Our Business Could be Adversely Affected.
We rely on UVMV, UTS, UOB, UOC, UNC, LMU, VIVIT
and Vin-de-Bona for a substantial portion of our preclinical capabilities, including reliance on their employees whom we fund to
conduct preclinical development of our product candidates. If there are delays or failures to perform their obligations, our product
candidates would be adversely affected. If our collaboration with these universities and institutions is unsuccessful or is terminated,
we would need to identify a new research and collaboration partner for our preclinical and clinical development. If we are unsuccessful
or significantly delayed in identifying a new collaboration and research partners, or unable to reach an agreement with such a
partner on commercially reasonable terms, development of our product candidates will suffer and our business would be materially
harmed.
Furthermore, if any of these universities or
institutions change their strategic focus, or if external factors cause any one of them to divert resources from our collaboration,
or if any one of them independently develops products that compete directly or indirectly with our product candidates using resources
or information it acquires from our collaboration, our business and results of operations could suffer.
Future Preclinical and Clinical
Development Collaborations May be Important to Us. If We Are Unable to Maintain these Collaborations, or if these Collaborations
Are Not Successful, Our Business Could be Adversely Affected.
For some of our product candidates, we may
in the future determine to collaborate with pharmaceutical and biotechnology companies for development of our product candidates.
We face significant competition in seeking appropriate collaborators. Our ability to reach a definitive agreement for any collaboration
will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions
of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. If we are unable to reach
agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development
of a product candidate, reduce or delay its development program or one or more of our other development programs, delay our potential
development schedule or increase our expenditures and undertake preclinical and clinical development activities at our own expense.
If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development activities,
we may not be able to further develop our product candidates or continue to develop our product candidates and our business may
be materially and adversely affected.
Future collaborations we may enter into may
involve the following risks:
| · | Collaborators may have significant discretion in determining the efforts and resources that they
will apply to these collaborations; |
| · | Collaborators may not perform their obligations as expected; |
| · | Changes in the collaborators’ strategic focus or available funding, or external factors,
such as an acquisition, may divert resources or create competing priorities; |
| · | Collaborators may delay discovery and preclinical development, provide insufficient funding for
product development of targets selected by us, stop or abandon preclinical or clinical development for a product candidate or have
to repeat or conduct new preclinical and clinical development for a product candidate; |
| · | Collaborators could independently develop, or develop with third parties, products that compete
directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more
likely to be successfully developed than ours; |
| · | Product candidates may be viewed by our collaborators as competitive with their own product candidates
or products, which may cause collaborators to cease to devote resources to the development of our product candidates; |
| · | Disagreements with collaborators, including disagreements over proprietary rights, contract interpretation
or the preferred course of development might cause delays or termination of the preclinical or clinical development or commercialization
of product candidates. This might lead to additional responsibilities for us with respect to product candidates, or might result
in litigation or arbitration, any of which would be time-consuming and expensive; |
| · | Collaborators may not properly maintain or defend our intellectual property rights or intellectual
property rights licensed to us or may use our proprietary information in such a way as to invite litigation that could jeopardize
or invalidate our intellectual property or proprietary information or expose us to potential litigation; |
| · | Collaborators may infringe the intellectual property rights of third parties, which may expose
us to litigation and potential liability; and |
| · | Collaborations may be terminated for the convenience of the collaborator and, if terminated, we
could be required to raise additional capital to pursue further development or commercialization of our product candidates. |
In addition, subject to its contractual obligations
to us, if a collaborator of ours is involved in a business combination, the collaborator might deemphasize or terminate the development
of any of our product candidates. If one of our collaborators terminates its agreement with us, we may find it more difficult to
attract new collaborators and our perception in the business and financial communities could be adversely affected.
If we are unable to maintain our collaborations,
development of our product candidates could be delayed and we may need additional resources to develop them.
We Rely on Dr. Günzburg, Dr.
Salmons and Dr. Löhr for the Development of Our Product Candidates. If They Decide to Terminate their Relationship with Us,
We May Not be Successful in the Development of Our Product Candidates.
Dr. Günzburg, Dr. Salmons and Dr. Löhr
are intimately involved in all of our scientific endeavors underway and being planned by us. These endeavors include preclinical
and clinical studies to be conducted in the United States on our behalf. These studies are designed to determine the effectiveness
of the our pancreatic cancer treatment in ameliorating the unbearable pain that is associated with advanced pancreatic cancer and
the effects of the treatment on the rate of accumulation of malignant ascites that occurs in patients with this disease. Also in
the cancer area, Dr. Günzburg, Dr. Salmons and Dr. Löhr will be involved in every aspect of our Phase 2b clinical trial
that will be conducted in Australia. In addition, they will be assisting us in the development of a treatment for diabetes that
will employ the Cell-in-a-Box® cellulose-based live cell encapsulation technology. Dr. Günzburg, Dr. Salmons
and Dr. Löhr are fulfilling a prominent role in the international Diabetes Consortium. They provide professional consulting
services to us through their respective consulting agreements with us. The consulting agreements may be terminated for any reason
at any time upon one party giving the other a written notice 30 days prior to the effective date of the termination. If that occurs,
we may not be successful in the development of our product candidates which could have a material adverse effect on us.
We Contract with Third Parties
for the Manufacture of Our Product Candidates for Preclinical Studies and Clinical Trials and Expect to Continue to do so for Commercialization.
This Reliance on Third Parties Increases the Risk that We Will Not Have Sufficient Quantities of Our Product Candidates or Such
Quantities at an Acceptable Cost, Which Could Delay, Prevent or Impair Our Development or Commercialization Efforts.
We do not currently own or operate manufacturing
facilities for the production of clinical quantities of our encapsulated live cell and ifosfamide product and other product candidates
and have limited personnel with manufacturing experience. We currently rely on and expect to continue to rely on third party contract
manufacturers to manufacture supplies of our product candidates for preclinical studies and clinical trials, as well as for commercial
manufacture of our product candidates, and these must be maintained for us to receive marketing approval for our products.
Our encapsulated live cell and ifosfamide product
and our other product candidates must be manufactured through complex, multi-step synthesis processes that are time-consuming and
involve special conditions at certain stages. Biologics and drug substance manufacture requires high potency containment, and containment
under aseptic conditions. Any performance failures on the part of our existing or future manufacturers could delay clinical development
or marketing approval of our product candidates.
Our agreements with our third party manufacturers
can be terminated by us or such manufacturers on short notice. If any of our manufacturers should become unavailable to us for
any reason, we may incur additional cost or delay in identifying or qualifying replacements. In addition, while we believe that
our existing manufacturer, Austrianova, or an alternative manufacturer, would be capable of continuing to produce our product candidates
or products, if approved, in commercial quantities, we may also need to identify a third-party manufacturer capable of providing
commercial quantities of our products. If we are unable to arrange for such a third-party manufacturing source or fail to do so
on commercially reasonable terms, we may not be able to successfully produce and market our encapsulated live cell and ifosfamide
product or any other product candidate or may be delayed in doing so.
Even if we are able to establish such arrangements
with third party manufacturers, reliance on third party manufacturers entails additional risks, including:
| · | Reliance on the third party for regulatory compliance and quality assurance; |
| · | The possible breach of the manufacturing agreement by the third party; |
| · | The possible misappropriation of our proprietary information, including our trade secrets and know-how;
and |
| · | The possible termination or nonrenewal of the agreement by the third party at a time that is costly
or inconvenient for us. |
Third party manufacturers may not be able to
comply with cGMP standards or the requirements of the Regulatory Agencies. Our failure, or the failure of our third party manufacturers,
to comply with these practices or requirements could result in sanctions being imposed on us, including clinical holds, fines,
injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product
candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect
supplies of our products.
Delays in the construction and certification
of Austrianova’s cGMP manufacturing facilities in Bangkok, Thailand could affect Austrianova’s ability to manufacture
encapsulated live cells on a timely basis and could adversely affect supplies of our product candidates.
Our encapsulated live cell and ifosfamide product
and any other product candidates that we may develop may compete with other product candidates and products for access to manufacturing
facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing
for us.
In addition, we expect to rely on our manufacturers
to purchase from third-party suppliers the materials necessary to produce our product candidates for our clinical studies. There
are a small number of suppliers for certain capital equipment and raw materials that are used in the manufacture of our product
candidates. Such suppliers may not sell these raw materials to our manufacturers at the times we need them or on commercially reasonable
terms. We do not have any control over the process or timing of the acquisition of these raw materials by our manufacturers. Moreover,
we currently do not have any agreements for the commercial production of these raw materials. Any significant delay in the supply
of a product candidate or the raw material components thereof for an ongoing clinical trial due to the need to replace a third-party
manufacturer could considerably delay completion of our clinical studies, product testing and potential regulatory approval of
our product candidates. If our manufacturers or we are unable to purchase these raw materials after regulatory approval has been
obtained for our product candidates, the commercial launch of our product candidates would be delayed or there would be a shortage
in supply, which would impair our ability to generate revenues from the sale of our product candidates.
Our current and anticipated future dependence
upon Austrianova and others for the manufacture of our product candidates may adversely affect our future profit margins and our
ability to commercialize any products that receive marketing approval on a timely and competitive basis.
Risks Related to Our Intellectual Property
If We Are Unable to Obtain and
Maintain Intellectual Property Protection for Our Technology and Products, or if the Scope of the Intellectual Property Protection
Obtained is Not Sufficiently Broad, Our Competitors Could Develop and Commercialize Technology and Products Similar or Identical
to Ours, and Our Ability to Commercialize Successfully Our Technology and Products May be Impaired.
Our success depends in large part on our ability
to obtain and maintain patent protection in the United States and other countries with respect to our proprietary technology and
products. We seek to protect our proprietary position by filing patent applications in the United States and abroad related to
our novel technologies and product candidates. Our patent portfolio includes patents and patent applications we exclusively licensed
from Bavarian Nordic/GSF, SG Austria and Austrianova.
The patent prosecution and/or patent maintenance
process is expensive and time-consuming, and we may not be able to file and prosecute or maintain all necessary or desirable patent
applications or maintain the existing patents at a reasonable cost or in a timely manner. We may choose not to seek patent protection
for certain innovations and may choose not to pursue patent protection in certain jurisdictions. Under the laws of certain jurisdictions,
patents or other intellectual property rights may be unavailable or limited in scope. It is also possible that we will fail to
identify patentable aspects of our discovery and preclinical development output before it is too late to obtain patent protection.
Moreover, in some circumstances, we do not
have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering
technology that we license from third parties. Therefore, these patents and applications may not be prosecuted and enforced in
a manner consistent with the best interests of our business.
The patent position of biotechnology and pharmaceutical
companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject
of much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the
United States. For example, India does not allow patents for methods of treating the human body. Publications of discoveries in
the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions
are typically not published until 18 or more months after filing, or in some cases not at all. Therefore, we cannot know with
certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications,
or that we were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability
and commercial value of our patent rights are highly uncertain. Any future patent applications may not result in patents being
issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing
competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States
and other countries may diminish the value of our patents or narrow the scope of our patent protection.
Recent patent reform legislation could increase
the uncertainties and costs surrounding the prosecution of any patent applications and the enforcement or defense of our licensed
patents. On September 16, 2011, the Leahy-Smith America Invents Act (“Leahy-Smith Act”) was signed into law. The
Leahy-Smith Act includes a number of significant changes to patent law in the United States. These include provisions that affect
the way patent applications are prosecuted and may also affect patent litigation. The United States Patent and Trademark Office
(“USPTO”) recently developed new regulations and procedures to govern administration of the Leahy-Smith Act. Many of
the substantive changes to patent law associated with the Leahy-Smith Act, in particular, the first to file provisions, only became
effective on March 16, 2013. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation
of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the
prosecution of our patent applications and the enforcement or defense of our licensed patents, all of which could have a material
adverse effect on our business and financial condition.
Moreover, we may be subject to a third-party
pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, reexamination, inter-party review,
post-grant review or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination
in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties
to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to
manufacture or commercialize products without infringing third-party patent rights. In addition, if the breadth or strength of
protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us
to license, develop or commercialize current our future product candidates.
Even if our owned and licensed patent applications
issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing
with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our owned or licensed
patents by developing similar or alternative technologies or products in a non-infringing manner.
The issuance of a patent is not conclusive
as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or
patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent
claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from
using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology
and products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents
protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and
licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or
identical to ours.
The risks described elsewhere pertaining to
our patents and other intellectual property rights also apply to the intellectual property rights that we license, and any failure
to obtain, maintain and enforce these rights could have a material adverse effect on our business. In some cases we may not have
control over the prosecution, maintenance or enforcement of the patents that we license, and our licensors may fail to take the
steps that we believe are necessary or desirable in order to obtain, maintain and enforce the licensed patents. Any inability on
our part to protect adequately our intellectual property may have a material adverse effect on our business, operating results
and financial position.
Obtaining and Maintaining Our Patent
Protection Depends on Compliance with Various Procedural, Document Submission, Fee Payment and other Requirements Imposed by Governmental
Patent Agencies. Our Patent Protection Could be Reduced or Eliminated for Non-Compliance with these Requirements.
Periodic maintenance fees, renewal fees, annuity
fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental
patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. The USPTO
and various non-United States governmental patent agencies require compliance with a number of procedural, documentary, fee payment
and other similar provisions during the patent application process. We employ reputable law firms and other professionals to help
us comply, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the
applicable rules. However, there are situations in which non-compliance can result in abandonment or lapse of the patent or patent
application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors
might be able to enter the market and this circumstance would have a material adverse effect on our business.
We May Become Involved in Lawsuits
to Protect or Enforce Our Patents or other Intellectual Property, Which Could be Expensive, Time Consuming and Unsuccessful.
Because competition in our industry is intense,
competitors may infringe or otherwise violate our issued patents, patents of our licensors or other intellectual property. To counter
infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time consuming. Any
claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe
their patents. In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable,
in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at
issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation proceeding could
put one or more of the patents associated with our business at risk of being invalidated or interpreted narrowly. We may also elect
to enter into license agreements in order to settle patent infringement claims or to resolve disputes prior to litigation, and
any such license agreements may require us to pay royalties and other fees that could be significant. Furthermore, because of the
substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our
confidential information could be compromised by disclosure.
We May Need to License Certain
Intellectual Property from Third Parties, and Such Licenses May Not be Available or May Not be Available on Commercially Reasonable
Terms.
A third party may hold intellectual property,
including patent rights, which are important or necessary to the development of our products. It may be necessary for us to use
the patented or proprietary technology of third parties to commercialize our products, in which case we would be required to obtain
a license from these third parties on commercially reasonable terms, or our business could be harmed, possibly materially. Although
we believe that licenses to these patents may be available from these third parties on commercially reasonable terms, if we were
not able to obtain a license, or are not able to obtain a license on commercially reasonable terms, our business could be harmed,
possibly materially.
Third Parties May Initiate Legal
Proceedings Alleging that We Are Infringing their Intellectual Property Rights, the Outcome of Which Would be Uncertain and Could
Have a Material Adverse Effect on the Success of Our Business.
Our commercial success depends upon our ability,
and the ability of our collaborators, to develop, manufacture, market and sell our product candidates and use our proprietary technologies
without infringing the proprietary rights of third parties. There is considerable intellectual property litigation in the biotechnology
and pharmaceutical industries. We may become party to, or threatened with, future adversarial proceedings or litigation regarding
intellectual property rights with respect to our products and technology, including interference or derivation proceedings before
the USPTO and various governmental patent agencies outside of the United States. Third parties may assert infringement claims against
us based on existing patents or patents that may be granted in the future.
If we are found to infringe a third party’s
intellectual property rights, we could be required to obtain a license from such third party to continue developing and marketing
our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at
all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies
licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In
addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to
have willfully infringed a patent. A finding of infringement could prevent us from commercializing our product candidates or force
us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the
confidential information or trade secrets of third parties could have a similar negative impact on our business.
We May Not be Successful in Obtaining
or Maintaining Necessary Rights for its Development Pipeline through Acquisitions and Licenses from Third Parties.
Presently we have rights to intellectual property
to develop our product candidates. Because our programs may involve additional product candidates that may require the use of proprietary
rights held by third parties, the growth of our business may depend in part on our ability to acquire, in-license or use these
proprietary rights. We may be unable to acquire or in-license any compositions, methods of use or other third-party intellectual
property rights from third parties that we identify. The licensing and acquisition of third-party intellectual property rights
is a competitive area, and a number of more established companies are also pursuing strategies to license or acquire third-party
intellectual property rights that we may consider attractive. These established companies may have a competitive advantage over
us due to their size, cash resources and greater clinical development and commercialization capabilities.
In addition, companies that perceive us to
be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual
property rights on terms that would allow us to make an appropriate return on our investment. If we are unable to successfully
obtain rights to required third-party intellectual property rights, our business, financial condition and prospects for growth
could suffer.
If We Are Unable to Protect the
Confidentiality of Our Trade Secrets, Our Business and Competitive Position Would be Harmed.
In addition to seeking patents for some of
our technology and product candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietary
information, to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into non-disclosure
and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific
collaborators, contract manufacturers, consultants, advisors and other third parties. We seek to protect our confidential proprietary
information, in part, by entering into confidentiality and invention or patent assignment agreements with our employees and consultants;
however, we cannot be certain that such agreements have been entered into with all relevant parties.
Moreover, to the extent we enter into such
agreements, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets
to unaffiliated third parties. We may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party
illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming and the outcome is unpredictable.
In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of
our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them,
or those to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets
were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.
Risk Factors Related to Our Stock
We Cannot Predict the Extent to
Which a Trading Market for Our Common Stock Will Develop or How Liquid that Market Might Become.
Our common stock is currently listed on the
OTC Link™ quotation platform of OTC Markets Group, Inc. We cannot predict the extent to which a trading market will
develop or how liquid that market might become. Accordingly, holders of our common stock may be required to retain their shares
for an indefinite period of time.
The OTC Link™ quotation system provides
significantly less liquidity than national stock exchanges. Quotes for stocks included on the OTC Link™ quotation system
are not listed in the financial sections of newspapers, as are those for the national stock exchanges. Therefore, prices for securities
traded solely on the OTC Link™ quotation system may be difficult to obtain, and holders of our common stock may be unable
to resell their shares at or near their original acquisition price or at any price. Market prices for our shares of common
stock will be influenced by a number of factors, including, but not limited to:
| · | The issuance of new shares pursuant to future offering; |
| · | Changes in interest rates; |
| · | New services or significant contracts and acquisitions; |
| · | Variations in quarterly operating results; |
| · | Change in financial estimates by securities analysts; |
| · | The depth and liquidity of the market for the Shares; |
| · | Investor perceptions of us and of investments based in the countries where our projects operate
and the project companies generally; and |
| · | General economic and other national and international conditions. |
Penny Stock Rules May Have an Adverse
Effect on Us.
Our securities sold as part of financing provided
to us are currently subject to “penny stock rules” that impose additional sales requirements on broker-dealers who
sell such securities to persons other than established customers and accredited investors, the latter of which are generally people
with assets in excess of $1,000,000 or annual income exceeding $200,000 or $300,000 jointly. For transactions covered by these
rules, we and/or broker-dealers must make a special suitability determination for the purchase of such securities and have received
the purchaser’s written consent to the transaction prior to the purchase. Additionally, for any transaction involving a penny
stock, unless exempt, the “penny stock rules” require the delivery, prior to the transaction, of a disclosure schedule
prescribed by the Commission relating to the penny stock market. The broker-dealer must also disclose the commissions payable to
both the broker-dealer and the registered representative and current quotations for the securities. Finally, monthly statements
must be sent disclosing recent price information on the limited market in penny stocks. Consequently, the “penny stock rules”
may restrict the ability of broker-dealers to sell our securities. The foregoing required penny stock restrictions will not apply
to our common stock if such securities maintain a market price of $5.00 or greater. Therefore, the challenge for us is that the
market price of our common stock may not reach or remain at such a level.
Shareholders should be aware that, according
to the Commission, the market for penny stocks has suffered in recent years from patterns of fraud and abuse. Such patterns
include, but are not limited to:
| · | Control of the market for the security by one or a few broker-dealers that are often related to
the promoter or issuer; |
| · | Manipulation of prices through prearranged matching of purchases and sales and false and misleading
press releases; |
| · | “Boiler room” practices involving high-pressure sales tactics and unrealistic price
projections by inexperienced sales persons; |
| · | Excessive and undisclosed bid-ask differentials and markups by selling broker-dealers; and |
| · | The wholesale dumping of the same securities by promoters and broker-dealers after prices have
been manipulated to a desired level, leaving investors with losses. |
Our executive officers are aware of these abuses
that have occurred historically in the penny stock market. Although we are in no position to dictate the behavior of the market
or of broker-dealers or others are engage in such abuses, management will strive within the confines of practical limitations to
prevent the described patterns from being established with respect to our common stock.
We May Experience Volatility in our Stock Price, which May
Adversely Affect the Trading Price of Our Common Stock.
To date, the market closing price of our common stock in 2015 has
ranged from $0.10 to $0.16 per share, and it may continue to experience significant volatility from time to time. Factors that
may affect the market price of our common stock include the following:
| · | Announcements of regulatory developments or technological innovations by us or our competitors; |
| · | Changes in our relationship with our licensors and other strategic partners; |
| · | Our quarterly operating results; |
| · | Litigation involving or affecting us; |
| · | Shortfalls in our actual financial results compared to our guidance or the forecasts of stock market analysts; |
| · | Developments in patent or other technology ownership rights; |
| · | Acquisitions or strategic alliances by us or our competitors; |
| · | Public concern regarding the safety of our products; and |
| · | Government regulation of drug pricing. |
We Have No Plans to Pay Dividends
in the Foreseeable Future, and Investors May Not Expect a Dividend as a Return of or on Any Investment in Us.
We have not paid dividends on our shares of
common stock and do not anticipate paying such dividends in the foreseeable future.
Our Investors May Suffer Future
Dilution Due to Issuances of Additional Shares of Our Common Stock for Various Reasons in the Future.
There may be substantial dilution to our shareholders
as a result of future decisions of our Board to issue shares without shareholder approval for cash transactions, services rendered,
acquisitions, payment of debt and other permissible reasons. We can give investors no assurance that they will be able to
sell their shares of our commons stock at or near the prices they ask or at all if they need money or otherwise desire to liquidate
their shares.
The Price of Our Common Stock is
Volatile, Which Substantially Increases the Risk that the Our Investors May Not be Able to Sell Their Shares at or above the Price
that the Investors Have Paid for their Shares.
Because of the price volatility in our shares
we have observed since its inception, investors in our common stock may not be able to sell their shares when they desire to do
so at a price the investors desire to attain. The inability to sell securities in a rapidly declining market may substantially
increase the risk of loss because the price of our common stock may suffer greater declines due to the historical price volatility
of our shares. Certain factors, some of which are beyond our control, that may cause our share price to fluctuate significantly
include, but are not limited to, the following:
| · | Variations in our quarterly operating results; |
| · | Loss of a key relationship or failure to complete significant product candidate programs; |
| · | Additions or departures of key personnel; and |
| · | Fluctuations in the stock market price and volume. |
In addition, in recent years the stock market
in general, and the over-the-counter markets in particular, have experienced extreme price and volume fluctuations. In some
cases, these fluctuations are unrelated or disproportionate to the performance of the underlying company. These market and
industry factors may materially and adversely affect our share price, regardless of our performance or whether we meet our business
objectives. In the past, class action litigation often has been brought against companies following periods of volatility
in the market price of those companies common stock. If we become involved in this type of litigation in the future, it could
result in substantial costs and diversion of management attention and resources, which could have a material adverse effect on
us and the trading price of our common stock.
Risks Related to Employee and Tax Matters, Managing Growth
and Macroeconomic Conditions
We Have a Limited Number of Employees
and Are Highly Dependent on Our Chief Executive Officer and Chief Operating Officer. Our Future Success Depends on the Our Ability
to Retain these Officers and other Key Executives and to Attract, Retain and Motivate Other Needed Qualified Personnel.
We are an early-stage clinical development
company with a limited operating history. As of April 30, 2015, we had four employees and several key consultants. We are highly
dependent on the research and development, clinical and business development expertise of the principal members of our management,
scientific and clinical teams. Recruiting and retaining qualified scientific, clinical, manufacturing and sales and marketing personnel
will also be critical to our success. The loss of the services of our executive officers or other key employees or consultants
could impede the achievement of our research, development and commercialization of our product candidates and seriously harm our
ability to successfully implement our business strategy.
Furthermore, replacing executive officers and
key employees and consultants may be difficult and may take an extended period of time because of the limited number of individuals
in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize
products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these
key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel.
We also experience competition for the hiring
of scientific and clinical personnel from universities and research institutions. In addition, we rely on other consultants and
advisors, including scientific and clinical advisors, to assist us in formulating our discovery, preclinical and clinical development
and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments
under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue
to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.
Our Ability to Use Our Net Operating Loss Carryforwards and
Certain Other Tax Attributes May be Limited.
Under Section 382 of the Internal Revenue Code of 1986, as amended,
if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change net operating
loss carryforwards and other pre-change tax attributes (such as research and development tax credits) to offset its post-change
income and taxes may be limited. In general, an “ownership change” occurs if there is a cumulative change in our ownership
by “5% shareholders” that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under
state tax laws.
If it is determined that we have in the past experienced an ownership
change, or if we experience one or more ownership changes as a result of this offering or future transactions in our stock, we
may be limited in our ability to use our net operating loss carryforwards and other tax assets to reduce taxes owed on the net
taxable income that we earn. Any such limitations on the ability to use our net operating loss carryforwards and other tax assets
could potentially result in increased future tax liability to us.
We Expect to Expand Our Development
and Regulatory Capabilities and Potentially Implement Sales, Marketing and Distribution Capabilities. As a result, We May Encounter
Difficulties in Managing its Growth, Which Could Disrupt Our Operations.
We expect to experience significant growth
in the number of our employees and the scope of our operations, particularly in the areas of drug development, regulatory affairs
and, if any of our product candidates receive marketing approval, sales, marketing and distribution. To manage our anticipated
future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities
and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience
of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion
of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant
costs and may divert our management and business development resources. Any inability to manage growth could delay the execution
of our business plans or disrupt our operations.
Unfavorable Global Economic Conditions
Could Adversely Affect Our Business, Financial Condition or Results of Operations.
Our results of operations could be adversely
affected by general conditions in the global economy and in the global financial markets. The recent global financial crisis caused
extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn, such as the recent
global financial crisis, could result in a variety of risks to our business, including our ability to raise additional capital
when needed on acceptable terms, if at all. This is particularly true in Europe, which is undergoing a continued severe economic
crisis. A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption. Any of the foregoing
could adversely impact our business.
Our Business and Operations Would
Suffer in the Event of System Failures.
Despite the implementation of security measures,
our internal computer systems and those of our CROs, collaborators and third-parties on whom we rely are vulnerable to damage from
computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Furthermore,
we have little or no control over the security measures and computer systems of our third-party collaborators. While we and, to
our knowledge, our third-party collaborators have not experienced any such system failure, accident or security breach to date,
if such an event were to occur and cause interruptions in our operations or the operations of our third-party collaborators, it
could result in a material disruption of our drug development programs. If any disruptions occur, they could have a material adverse
effect on our business.
ITEM 1B. UNRESOLVED
STAFF COMMENTS
As of May 1, 2015, we no longer qualified as
a smaller reporting company. However, because we are permitted to satisfy our obligations under this Report by complying with the
requirements applicable to a smaller reporting company, we are not required to include information called for by this item.
ITEM 2. PROPERTIES
Our principal office is located at 12510 Prosperity
Drive, Suite 310, Silver Spring, Maryland 20904. This office is leased and consists of approximately 1,900 square feet. The lease
ends July 31, 2016.
ITEM 3. LEGAL PROCEEDINGS
There is no material litigation currently pending
or threatened against us or, to our knowledge, any of our officers or directors in their capacity as such.
ITEM 4. MINE SAFETY
DISCLOSURES
Not Applicable.
ITEM 5. MARKET
FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Shares of our common stock are quoted
and traded on the OTCQB (www.otcmarkets.com) as a fully reporting Over-The-Counter Bulletin Board company under the classification
of OTCQB utilizing the trading symbol “PMCB.”
The following table sets forth the high
and low bid prices for our shares for each quarter during the two fiscal years ended April 30, 2015 and 2014. The prices reflect
inter-dealer prices, without retail mark-up, mark-down or commission and are not intended to represent actual transactions.
Date |
|
Bid Price |
FY 2015 |
|
HIGH |
|
LOW |
First Quarter |
|
$ |
0.34 |
|
|
|
0.21 |
|
Second Quarter |
|
$ |
0.30 |
|
|
|
0.17 |
|
Third Quarter |
|
$ |
0.26 |
|
|
|
0.10 |
|
Fourth Quarter |
|
$ |
0.26 |
|
|
|
0.10 |
|
FY 2014 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
0.22 |
|
|
|
0.09 |
|
Second Quarter |
|
$ |
0.18 |
|
|
|
0.10 |
|
Third Quarter |
|
$ |
0.23 |
|
|
|
0.10 |
|
Fourth Quarter |
|
$ |
0.62 |
|
|
|
0.15 |
|
At April 30, 2015, the market price
of our common stock was $0.16 per share.
As of April 30, 2015, there were 732,760,536
issued and outstanding shares of common stock. We were informed these shares are held by 1,600 shareholders of record.
Dividend Policy
We have not paid and does not plan to
pay cash dividends at this time. Our Board of Directors (“Board”) will decide any future payment of dividends, depending
on the results of operations, financial condition, capital requirements and other relevant factors.
Issuer Purchases of Equity Securities
We did not repurchase any of our securities
registered under Section 12 of the Exchange Act during the year ended April 30, 2015.
Securities Authorized for Issuance under Equity Compensation
Plans
The information in the following table is as
of April 30, 2015:
Name |
|
Number of shares or units of stock that have not vested(#) |
|
|
Market value of shares or units of stock that have not vested($) |
|
|
Equity incentive plan awards: Number of unearned shares, units or other rights that have not vested(#) |
|
|
Equity incentive plan awards: Market or payout value of unearned shares, units or other rights that have not vested ($) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kenneth L. Waggoner |
|
(1) 1,800,000 |
|
|
(2) $ 279,180 |
|
|
(3) 2,200,000 |
|
|
(4) $ 177,550 |
|
Gerald W. Crabtree |
|
(5) 900,000 |
|
|
(6) $ 139,590 |
|
|
(7) 2,200,000 |
|
|
(8) $ 177,550 |
|
Carlos Trujillo |
|
(9) 900,000 |
|
|
(10) $ 139,590 |
|
|
(11) 2,200,000 |
|
|
(12) $ 177,550 |
|
(1) Represents
the number of securities to be issued to Kenneth L. Waggoner during fiscal year 2015 in order to issue him 100,000 shares of common
stock per month under his oral employment agreement that was in effect during the period May 1, 2014 to December 31, 2014 and 200,000
shares of common stock per month under his Executive Compensation Agreement that was in effect during the period January 1, 2015
through April 30, 2015. These shares were issued as compensation for his services as our Chairman of the Board, Chief Executive
Officer, President and General Counsel and the Chief Executive Officer and General Counsel of Viridis Biotech.
(2) Represents
the value of the securities to be issued to Kenneth L. Waggoner at the closing price of our common stock on April 30, 2015 of $279,180.
(3) Represents
the number of unvested stock option shares granted to Kenneth L. Waggoner under the terms of the Second Stock Option Agreement
dated March 10, 2015 which provided for 2,400,000 share option vesting at a rate of 200,000 shares per month subject to his Executive
Compensation Agreement.
(4) Represents
the unvested value of the stock options using the Black Scholes method granted to Kenneth L. Waggoner.
(5) Represents
the number of securities to be issued to Gerald W. Crabtree during the fiscal year 2015 in order to issue him 100,000 shares of
common stock per month under his an operative Board resolution that was in effect during the period May 1, 2014 to December 31,
2014 and 100,000 shares of common stock per month under his Executive Compensation Agreement that was in effect during the period
January 1, 2015 through April 30, 2015. These shares were issued as compensation for his services as a director and our Chief Operating
Officer and the Chief Operating Officer of Viridis Biotech.
(6) Represents
the value of the securities to be issued to Gerald W. Crabtree at the closing price of our common stock on April 30, 2015 of $139,590.
(7) Represents
the number of unvested stock option shares granted to Gerald W. Crabtree under the terms of the Second Stock Option Agreement dated
March 10, 2015 which provided for 2,400,000 share option vesting at a rate of 200,000 shares per month subject to his Executive
Compensation Agreement.
(8) Represents
the unvested value of the stock options using the Black Scholes method granted to Gerald W. Crabtree.
(9) Represents
the number of securities to be issued to Carlos Trujillo at 100,000 shares of common stock per month under his Employment Agreement
that was in effect during the period January 1, 2015 through April 30, 2015. These shares were issued as compensation for his services.
(10) Represents
the value of the securities to be issued to Carlos Trujillo at the closing price of our common stock as of April 30, 2015 of $139,590.
(11) Represents
the number of unvested stock option shares granted to Carlos Trujillo under the terms of the Option Agreement dated March 10, 2015
which provides for 2,400,000 share option vesting at a rate of 200,000 shares per month subject to his Employment Agreement.
(12) Represents
the unvested value of the stock options using the Black Scholes method granted to Carlos Trujillo.
Recent Issuance of Unregistered Securities
During the year ended April 30, 2015,
we issued an aggregate of 5,500,000 shares of common stock to two consultants. The first issuance was for 5,000,000 shares at
approximately $0.10, which was valued at the date of issuance. The second issuance was for 500,000 shares at approximately $0.18,
which was valued at the date of issuance. The non-cash expense for these share issuances totaled $604,500.
During the year ended April 30, 2015, we issued
3,600,000 shares of common stock to officers as part of their Executive Compensation Agreements. These shares vest on a quarterly
basis over a twelve month period. The 900,000 shares that vested were valued at the date of vesting and resulted in a non-cash
compensation expense of $125,460.
During the year ended April 30, 2015, we issued
1,200,000 shares of common stock to an employee as part of his Employee Agreement. These shares vest on a quarterly basis over
a twelve month period. The 300,000 shares that vested were valued at the date of vesting and resulted in a non-cash expense of
$41,820.
All shares were issued without registration
under the Securities Act in reliance upon the exemption afforded by Section 4(2) of that Act based on the limited number of investors,
the sophistication of the individuals involved and the use of restrictive legends on the shares certificates issued to prevent
a public distribution of the relevant securities. No underwriters were involved in any of the foregoing issuances
ITEM 6. SELECTED
FINANCIAL DATA
As of May 1, 2015, we no longer qualified
as a smaller reporting company. However, because we are permitted to satisfy our obligations under this Report by complying with
the requirements applicable to a smaller reporting company, we are not required to include information called for by this item.
ITEM 7. MANAGEMENT’S DISCUSSION
AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (AS RESTATED)
Summary of Impact of Restatement
on Financial Condition and Results of Operations
The Company restated its consolidated
financial statements as of and for the year ended April 30, 2015 to reflect adjustments made to correct the treatment
of the issuance of certain shares of common stock and certain warrants and certain other matters, as further described below,
resulting in a material understatement to assets, a material overstatement to liabilities and a material understatement to stockholders’
equity for the fourth quarter of the year ended April 30, 2015, as well as corrections to disclosures relating to certain issuances
of options of common stock to certain directors and officers of the Company. The impact of the restatement is reflected below
in this Management's Discussion and Analysis of Financial Condition and Results of Operations and in the Restated Financial Statements
contained in this Amended Filing.
The adjustments described above relate
to the Company’s issuance of certain cashless warrants in connection with its entry into the Consultant Agreement with a
consultant on March 23, 2015. The Company accounted for the cashless warrants as a derivative liability in the Original
Filing. However, upon further analysis, the Company determined that the cashless warrants should have been accounted for as equity
in accordance with U.S. GAAP. Additionally, the Company determined that the Consultant Agreement, issuance of shares of common
stock to the consultant pursuant to the Consultant Agreement and the issuance of the cash warrants and the cashless warrants to
the consultant should have been recorded as a prepaid asset and amortized over the term of the Consultant Agreement in accordance
with U.S. GAAP. In the Original Filing, the Company recorded a derivative liability of $492,049 on its consolidated balance sheets
as of and for the year ended April 30, 2015. As a result of the Company’s determination that the cashless warrants
should be accounted for as equity, and that the Consultant Agreement, cash warrants and cashless warrants should be accounted
for as a prepaid asset, the Company decreased general and administrative expenses by the net amount of $434,754 on its consolidated
statements of operations for the year ended April 30, 2015, and increased prepaid expenses and other assets by the amount of $1,349,024,
net of amortization, and decreased by the amount of $492,049 its total current liabilities on its consolidated balance sheet as
of April 30, 2015, as set forth in the Restated Financial Statements. Moreover, the Company recorded a decrease to its accumulated
deficit in the amount of $926,803, an increase to additional paid in capital in the amount of $914,270 and an increase to total
stockholders’ equity in the amount of $1,841,073. As set forth in the Restated Financial Statements, the effect of the timing
of the recognition of the cashless warrant expense and the reclassification of the Consultant Agreement, cash warrants and cashless
warrants to prepaid assets also resulted in a decrease of $926,803 to reported net loss.
This summary does not purport to be
a complete discussion of the impact of the restatement described above and additional effects of the restatement are presented
below in this Management's Discussion and Analysis of Financial Condition and Results of Operations and in the Restated Financial
Statements contained in this Amended Filing, including, but not limited to, Note 1A to the Restated Financial Statements.
The following discussion may
contain forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those
discussed here. Factors that could cause or contribute to such differences include, but are not limited to, any factors discussed
in this section as well as factors described in “Part II, Item 1A – Risk Factors.”
Overview
We are a clinical stage biotechnology
company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon our proprietary cellulose-based
live cell encapsulation technology, which we refer to as Cell-in-a-Box®. We are working to advance clinical research
and development of new cellular-based therapies in the oncology and diabetes arenas. We are now actively engaged with Austrianova
and other entities in preparation for clinical trials for the treatment of pancreatic cancer and its symptoms using encapsulated
live cells similar to those used in the previous Phase 1/2 and Phase 2 clinical trials discussed above. We are also involved in
preclinical studies to development treatment for insulin dependent diabetes.
Performance Indicators
Non-financial performance indicators
used by management to manage and assess how the business is progressing will include, but are not limited to, the ability to: (i)
acquire appropriate funding for all aspects of our operations; (ii) acquire and complete necessary contracts; (iii) complete activities
for producing cells and having them encapsulated for the planned preclinical studies and clinical trials; (iv) have regulatory
work completed to enable studies and trials to be submitted to regulatory agencies; (v) initiate all purity and toxicology cellular
assessments; and (vi) ensure completion of cGMP produced encapsulated cells to use in our clinical trials.
There are numerous factors required
to be completed successfully in order to ensure our final product candidates are ready for use in our clinical trials.
Therefore, the effects of material transactions with related parties and certain other parties to the extent necessary for such
an undertaking may have substantial effects on both the timeliness and success of our current and prospective financial position
and operating results. Nonetheless, we are actively working to ensure strong ties and interactions to minimize the inherent risks
regarding success. From our assessments to date, we do not believe there are factors which will cause materially different amounts
to be reported than those presented in this Report and aim to assess this regularly to provide the most accurate information to
our shareholders.
Quarterly Financial Data (As Restated)
The following table sets forth unaudited statements
of operations data for each quarter during our most recent two fiscal years. This quarterly information has been derived from our
unaudited condensed financial statements and, in the opinion of management, includes all adjustments, consisting only of normal
recurring adjustments, necessary for a fair presentation of the information for the periods covered. The quarterly financial data
should be read in conjunction with our consolidated financial statements and related notes. The operating results for any quarter
are not necessarily indicative of the operating results for any future period.
| |
Quarter Ended 31 July | | |
Quarter Ended 31 Oct | | |
Quarter Ended 31 Jan | | |
Quarter Ended 30 April | |
2015 | |
| | | |
| | | |
| | | |
| | |
Net revenue | |
$ | – | | |
$ | – | | |
$ | – | | |
$ | – | |
Cost of revenue | |
| – | | |
| – | | |
| – | | |
| – | |
Gross profit | |
| – | | |
| – | | |
| – | | |
| – | |
Operating expenses | |
| 1,583,160 | | |
| 6,200,845 | | |
| 1,456,554 | | |
| 4,020,176 | |
Other income (expenses), net | |
| (1,664 | ) | |
| 3,336,402 | | |
| (1,496 | ) | |
| (213 | ) |
Net loss | |
$ | (1,584,824 | ) | |
$ | (2,864,443 | ) | |
$ | (1,458,050 | ) | |
$ | (4,020,389 | ) |
Net loss per common share, Basic and Diluted | |
$ | (0.00 | ) | |
$ | (0.01 | ) | |
$ | (0.00 | ) | |
$ | (0.01 | ) |
| |
Quarter Ended 31 July | | |
Quarter Ended 31 Oct | | |
Quarter Ended 31 Jan | | |
Quarter Ended 30 April | |
2014 | |
| | | |
| | | |
| | | |
| | |
Net revenue | |
$ | – | | |
$ | – | | |
$ | – | | |
$ | – | |
Cost of revenue | |
| – | | |
| – | | |
| – | | |
| – | |
Gross profit | |
| – | | |
| – | | |
| – | | |
| – | |
Operating expenses | |
| 1,400,691 | | |
| 448,570 | | |
| 681,080 | | |
| 16,448,801 | |
Other income (expenses), net | |
| (3,265,676 | ) | |
| (5,209,500 | ) | |
| 222,308 | | |
| (22,010 | ) |
Net loss | |
$ | (4,666,367 | ) | |
$ | (5,658,070 | ) | |
$ | (458,772 | ) | |
$ | (16,470,811 | ) |
Net loss per common share, Basic and Diluted | |
$ | (0.01 | ) | |
$ | (0.01 | ) | |
$ | (0.00 | ) | |
$ | (0.03 | ) |
Liquidity and Capital Resources (As Restated)
Our consolidated financial statements
and related disclosures have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction
of liabilities in the normal course of business. Accordingly, the consolidated financial statements do not include any adjustments
that might be necessary should we be unable to continue in existence. We have not generated any revenues and have not yet achieved
profitable operations. There is no assurance that profitable operations, if ever achieved, could be sustained on a continuing
basis. In addition, development activities, preclinical studies, clinical trials and commercialization of our product candidates
will require significant additional financing. Our deficit accumulated through April 30, 2015 was $78,627,833. We expect
to incur substantial and increasing losses in future periods.
Our ability to successfully pursue our
business is subject to certain risks and uncertainties, including, among other things, uncertainty of product development, competition
from third parties, uncertainty of capital availability, uncertainty in our ability to enter into agreements with collaborative
partners, dependence on third parties and dependence on key personnel. We plan to finance future operations with a combination
of proceeds from the issuance of equity, debt, licensing fees and revenues from future product sales, if any. We have not generated
positive cash flows from operations, and there are no assurances that we will be successful in obtaining an adequate level of financing
for the development and commercialization of our planned products. We believe that our cash as of April 30, 2015, combined with
the sales of our common stock described below, will provide us with the ability to fund our operations through the end of 2016.
However, there can be no assurance in this regard. Such actions primarily include raising additional capital from existing investors
or securing additional financing.
From our present assessments, we do not
believe there are trends, events or uncertainties that have, or are reasonably likely to have, a material effect on our short-term
or long-term liquidity. Our research and development activities are scalable. This means that we can increase or decrease our projected
preclinical and clinical projects based on our available cash. We have no contractual obligations to perform clinical trials. We
anticipate that, during the latter part of this year or next, we will perform certain clinical trials based on the availability
of our cash. The principal source of our cash is the sale of our common stock as part of our S-3 Registration Statement.
Overall, the statement of cash flow is
the focal point for our liquidity, although the exercising of warrants and/or options at appropriate times by investors, consultants,
officers and directors of us will potentially have important positive effects on our liquidity. We also believe that the relationships
between changes in operating results may induce changes in liquidity, in particular material changes in working capital components
as seen by both acquisition of new capital through the “at-the-market” facility described below and conversion of
warrants and/or options by investors, consultants, officers and directors of us. We rely solely on working capital as our liquidity
indicator since we do not presently have any open credit lines, although we may try to obtain credit lines in the future. Further,
as has often been a part of our mechanism(s) to maintain overall liquidity, internal sources of liquidity from others associated
with us may be utilized if and when needed.
We do not utilize any advanced methodology
of cash management beyond paying our normal expenses, yet we have begun to make important risk management policies to maintain
success and ease the assessment of our financial condition.
On February 14, 2014, we entered into
a purchase agreement (“Lincoln Park Purchase Agreement”) and a registration rights agreement with Lincoln Park Capital
Fund, LLC pursuant to which Lincoln Park purchased $2,000,000 of our common stock. Under the Lincoln Park Purchase Agreement, we
have the right to sell to Lincoln Park up to $25,000,000 in shares of additional common stock, subject to certain limitations.
On May 28, 2014, we and Lincoln Park
entered into a Mutual Termination and Release Agreement (“Lincoln Park Termination Agreement”) terminating the Lincoln
Park Purchase Agreement. The Lincoln Park Termination Agreement provides that: (i) the representations and warranties of Lincoln
Park and us contained in the Lincoln Park Purchase Agreement; (ii) the covenants regarding “Variable Rate Transactions”
(as defined in the Lincoln Park Purchase Agreement) contained in the Lincoln Park Purchase Agreement (“Variable Rate Covenants”);
(iii) the indemnification provisions set forth in Section 9 of the Lincoln Park Purchase Agreement; (iv) the agreements and covenants
set forth in the Lincoln Park Purchase Agreement regarding notice, governing law and certain other related administrative provisions;
and (v) the obligations of us to register for resale all 14,125,000 shares of common stock then owned by Lincoln Park each survive
such termination and continue in full force and effect indefinitely, and provided further that the Variable Rate Covenants will
terminate upon the earlier of the one year anniversary of the effectiveness of the registration referred to in the preceding clause
(v) (“Effective Date”) and the date on which Lincoln Park has sold all of its shares of common stock.
In addition, Lincoln Park consented
to us entering into the Chardan Agreement (as defined below), so long as there are no provisions within the Chardan Agreement that
in any manner, directly or indirectly, limit Lincoln Park’s ability to carry out or effect the sale of shares of common stock
pursuant to a registration statement or otherwise, or in any manner, directly or indirectly, conflict with the surviving obligations
under the Lincoln Park Termination Agreement. We issued 1,062,500 shares of our common stock to Lincoln Park in connection with
the Lincoln Park Termination Agreement.
On May 28, 2014, we entered into a financial
advisory offering and an at the market offering engagement agreement (“Chardan Agreement”) with Chardan Capital Markets,
LLC (“Chardan”) pursuant to which Chardan agreed to use its reasonable best efforts to act as our sales agent in connection
with the sale of our common stock in “at-the-market” or privately negotiated transactions of up to $50,000,000, depending
upon market conditions and at our discretion. In connection with such transactions, we agreed to pay Chardan: (i) a cash fee of
3% of the gross proceeds from the sale of any shares of common stock sold in an “at-the-market” offering; and (ii)
a cash fee of 7% of the aggregate sales price of any distinct blocks of common stock sold under the Chardan Agreement, plus five-year
warrants representing 5% of the number of shares of common stock sold. In addition, we agreed to reimburse certain expenses of
Chardan in an amount not to exceed $15,000.
With the proceeds received upon the sale
of shares of common stock to Lincoln Park, through bridge financing being provided by new investors and existing shareholders
and with the sale of our stock under the Chardan Agreement, we have been able to maintain sufficient capital resources to meet
projected cash flow needs. If we are unable to raise sufficient funds through the sale of our common stock and we are unable to
raise additional capital on acceptable terms through other means, our business, results of operations, liquidity and financial
condition will be materially adversely affected. We believe that the “at-the-market” sale of our shares will provide
sufficient capital to fund our operations through July 31, 2016. Our current cash expenditures are approximately $250,000 per
month. As of July 27, 2015, we had approximately $3,025,000 in cash.
Year ended April 30, 2015 compared to years ended
April 30, 2014 and 2013 (As Restated)
Revenue
We had no revenues in the fiscal years ended April 30, 2015 and
2014.
Operating Expenses (As Restated)
As a result of the restatement of our
consolidated financial statements for the year ended April 30, 2015 relating to the change in the accounting treatment of cashless
warrants and other corrections, consolidated general and administrative expenses (consulting expense) initially increased by $914,270.
The reclassifications of the cashless warrants, cash warrants and the common stock issuance under the Consultant Agreement to
prepaid expenses reduced consulting expense by $1,349,024 for a net reduction to consolidated general and administrative expenses
in the amount of $434,754. Accordingly, consolidated general and administrative expenses decreased from $3,711,243 to $3,276,489
for the year ended April 30, 2015.
The total operating expenses during the
year ended April 30, 2015 decreased by $5,718,407 to $13,260,735 from $18,979,142 in the year ended April 30, 2014. The
decrease is attributable to a reduction in compensation expense as we awarded less stock based compensation in 2015 than in 2014.
For the year ended April 30, 2014, there was an increase in operating expenses of $17,292,241 to $18,979,142 from $1,686,901 in
the year ended April 30, 2013. The increase was attributable to an increase in stock based compensation in 2014. The table below
provides additional details relating to our operating expenses.
Operating expenses: | |
Year ended April 30, 2015 | | |
Change - Increase (Decrease) and Percent | | |
Year ended April 30, 2014 | | |
Change - Increase (Decrease) and Percent | | |
Year ended April 30, 2013 | |
Research and development | |
$ | 3,476,912 | | |
$ | 3,153,412 | | |
$ | 323,500 | | |
$ | 323,500 | | |
$ | – | |
| |
| | | |
| 975 | % | |
| | | |
| 100 | % | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Compensation expense | |
$ | 6,489,334 | | |
$ | (7,120,661 | ) | |
$ | 13,609,995 | | |
$ | 12,931,288 | | |
$ | 678,707 | |
| |
| | | |
| -52 | % | |
| | | |
| 1905 | % | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Director fees | |
$ | 18,000 | | |
$ | (750,000 | ) | |
$ | 768,000 | | |
$ | 768,000 | | |
$ | – | |
| |
| | | |
| -98 | % | |
| | | |
| 100 | % | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
General and administrative, legal and sales and marketing | |
$ | 3,276,489 | | |
$ | (1,001,158 | ) | |
$ | 4,277,647 | | |
$ | 3,269,453 | | |
$ | 1,008,194 | |
| |
| | | |
| -23 | % | |
| | | |
| 324 | % | |
| | |
Loss from operations (As Restated)
As a result of the restatement of our
consolidated financial statements for the year ended April 30, 2015 relating to the change in the accounting treatment of cashless
warrants and other corrections, consolidated general and administrative expenses (consulting expense) initially increased by $914,270.
The reclassification of cashless warrants, cash warrants and the share issuance under the Consultant Agreement to prepaid expenses
resulted in a reduction to consulting expense by the amount of $1,349,024 for a net reduction to consolidated general and administrative
expenses in the amount of $434,754. Accordingly, the loss from operations decreased by $434,754 from $13,695,489 to $13,260,735
for the year ended April 30, 2015.
Loss from operations during the year
ended April 30, 2015 decreased by $5,718,407 from $18,979,142 in the year ended April 30, 2014 to $13,260,735. The decrease
is attributable to a reduction in compensation expense as we awarded less stock based compensation in 2015 than in 2014. For the
year ended April 30, 2014, there was an increase in loss from operations of $17,294,781 to $18,979,142 from $1,684,361 in the
year ended April 30, 2014. The increase was attributable to an increase in stock based compensation in 2014.
Other income (expenses), net (As Restated)
As a result of the restatement of our
consolidated financial statements for the year ended April 30, 2015 relating to the change in the accounting treatment of cashless
warrants and other corrections, total other income increased by $492,049 due to the reversal of the unrealized loss on change
in the derivative liability. Total other income increased from $2,840,980 to $3,333,092 for the year ended April 30, 2015.
Other income, net for the year ended April
30, 2015 was $3,333,029 as compared to other expense, net of $8,274,878 in the year ended April 30, 2014. Other income,
net for the year ended April 30, 2015 is attributable to gain on the recovery of 15.6 million shares from officers and directors
as part of three settlements. Other expenses, net for the year ended April 30, 2014 was $8,274,878 as compared to other income,
net of $86,259 in the year ended April 30, 2013. Other expenses, net for the year ended April 30, 2014 are attributable to a non-cash
expense of $5,895,000 on the conversion of preferred stock, a non-cash expense of $3,993,295 for settlement of debt and a recovery
of $1,633,380 on the forgiveness of debt.
Discussion of Operating, Investing and Financing Activities
The following table presents a summary of our sources and
uses of cash for the years ended April 30,
| |
Year Ended April 30, 2015 | | |
Year Ended April 30, 2014 | | |
Year Ended April 30, 2013 | |
Net cash used in operating activities: | |
$ | (4,560,169 | ) | |
$ | (1,554,708 | ) | |
$ | (390,426 | ) |
Net cash used in investing activities: | |
$ | – | | |
$ | (3,559,069 | ) | |
$ | (646,750 | ) |
Net cash provided by financing activities: | |
$ | 3,641,974 | | |
$ | 8,530,944 | | |
$ | 1,220,756 | |
Effect of currency rate exchange | |
$ | 1,462 | | |
$ | – | | |
$ | – | |
Increase (decrease) in cash | |
$ | (916,733 | ) | |
$ | 3,417,167 | | |
$ | 183,580 | |
Operating Activities:
The cash used in operating activities for the
years ended April 30, 2015, 2014 and 2013 are a result of our net losses offset by securities issued for services and compensation,
changes to prepaid expenses, accounts payable and accrued expenses for 2015 and 2013 and increased by the loss on recovery of shares
for compensation and services, the loss on settlement of preferred stock, forgiveness of debt, changes to prepaid expenses, accounts
payable and accrued expenses for 2014.
Investing Activities:
The cash used in investing activities is mainly attributable to
the purchase of licenses.
Financing Activities:
The cash provided from financing activities
is mainly attributable to the proceeds from the sale of our common stock.
Off-Balance Sheet Arrangements
Except as described below, we have no off-balance
sheet arrangements that could have a material current effect or that are reasonably likely to have a material future effect on
our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures,
or capital resources.
As we reach certain “milestones”
in the progression of the live cell encapsulation technology towards the development of treatments for cancer and diabetes, payments
will be made by us to SG Austria or Austrianova. The future royalty and milestone payments are as follows: (i) two percent royalty
on all gross sales; (ii) ten percent royalty on gross revenues from sublicensing; (iii) milestone payments of $100,000 after enrollment
of the first human patient in the first clinical trial for each product; (iv) $300,000 after the enrollment of the first human
patient in the first Phase 3 clinical trial; and (v) $800,000 after obtaining a marketing authorization the Regulatory Agencies.
Additional milestone payments of $50,000 after the enrollment of the first veterinary patient for each product and $300,000 after
obtaining marketing authorization for each veterinary product are required.
Critical Accounting Estimates and Policies
Our consolidated financial statements
are prepared in accordance with U.S. GAAP. In connection with the preparation of our consolidated financial statements, we are
required to make assumptions and estimates about future events and apply judgments that affect the reported amounts of assets,
liabilities, revenue and expenses and the related disclosures. We base our assumptions, estimates and judgments on historical experience,
current trends and other factors that management believes to be relevant at the time our consolidated financial statements are
prepared. On a regular basis, management reviews the accounting policies, assumptions, estimates and judgments to ensure that our
consolidated financial statements are presented fairly and in accordance with U.S. GAAP. However, because future events and their
effects cannot be determined with certainty, actual results could differ from our assumptions and estimates and such differences
could be material.
Our significant accounting policies are
discussed in Note 3 of the notes to our consolidated financial statements included in Item 8, “Financial Statements and Supplementary
Data” of this Report. Management believes that the following accounting estimates are the most critical to aid in fully understanding
and evaluating our reported financial results and require management’s most difficult, subjective or complex judgments, resulting
from the need to make estimates about the effects of matters that are inherently uncertain. Management has reviewed these critical
accounting estimates and related disclosures with our Board.
Research and Development Expenses
Research and development expenses consist of
costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs to acquire technologies, including
licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred. Technology
developed for use in our product candidates is expensed as incurred until technological feasibility has been established.
Stock-based Compensation
Our stock-based employee compensation plans
are described in Note 8 of the Notes to Financial Statements. We follow the provisions of ASC 718, Compensation - Stock Compensation
(“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based awards
made to employees.
For stock warrants paid in consideration of
services rendered by non-employees, we recognize compensation expense in accordance with the requirements of ASC 505-50, Equity-Based
Payments to Non-Employees (“ASC 505-50”).
Net Income (Loss) Per Share
Basic net income (loss) per common share is
computed using the weighted-average number of common shares outstanding. Diluted net income (loss) per common share is computed
using the weighted-average number of common shares and common share equivalents outstanding. Potentially dilutive stock options
and warrants to purchase approximately 125,419,908, 57,665,600 and 59,433,600 shares at April 30, 2015, 2014 and 2013, respectively,
were excluded from the computation of diluted net income (loss) per share, because the effect would be anti-dilutive.
New Accounting Pronouncements
For a discussion of all recently adopted
and recently issued but not yet adopted accounting pronouncements, see “New Accounting Pronouncements” in Note 3 of
our notes to our consolidated financial statements included in Item 8 , “Financial Statements and Supplementary Data”
of this Report.
ITEM 7A. QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
As of May 1, 2015, we no longer qualified
as a smaller reporting company. However, because we are permitted to satisfy our obligations under this Report by complying with
the requirements applicable to a smaller reporting company, we are not required to include information called for by this item.
ITEM 8. FINANCIAL STATEMENTS AND
SUPPLEMENTARY DATA (AS RESTATED)
Our consolidated financial statements
and schedule and consolidated notes thereto as of April 30, 2015, 2014 and 2013, and for each of the three years in the period
ended April 30, 2015, together with the reports thereon of our independent registered public accounting firm, are set forth on
pages F-1 to F-31 of this Report.
ITEM 9. CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURES
The Company’s principal certifying accountants,
Robison Hill & Co., notified us of their election to cease representing public companies. On May 26, 2015, the Board approved
the engagement of our new auditors, Farber, Hass Hurley LLP and the dismissal of Robinson Hill & Co. There were no disagreements
and there was no dissatisfaction with the prior auditors over the past three years.
ITEM 9A. CONTROLS AND PROCEDURES
(AS RESTATED)
In connection with the Original Filing,
our management, including our Chief Executive Officer, President and General Counsel, as its principal executive officer and acting
principal financial officer (“Principal Executive Officer” or “Principal Executive Officer and Financial Officer”),
and our Vice President of Finance (“Vice President of Finance”) evaluated the effectiveness of our “disclosure
controls and procedures,” as such term is defined in Rule 13a-15(e) promulgated under the Exchange Act. Disclosure controls
and procedures are designed to ensure that the information required to be disclosed in the reports that we file or submit to the
Commission pursuant to the Exchange Act is recorded, processed, summarized and reported within the time period specified by the
Commission’s rules and forms and is accumulated and communicated to our management, including our Principal Executive Officer,
as appropriate to allow timely decisions regarding required disclosures. As reported in the Original Filing, based upon this
evaluation, the Principal Executive Officer and Vice President of Finance have concluded that, as of April 30, 2015, our disclosure
controls and procedures were not effective due to the material weaknesses in internal control over financial reporting described
under Management’s Report on Internal Control over Financial Reporting in the Original Filing. In connection
with the filing of this Amended Filing and the Restatements discussed above under the caption “Explanatory Note” and
in Note 1A to our Restated Financial Statements, management, including our Principal Executive Officer and the Vice President
of Finance, reassessed the effectiveness our disclosure controls and procedures and have concluded that, as of April 30, 2015,
our disclosure controls and procedures were not effective due to the material weaknesses in internal control over financial reporting
described in the Original Filing and the additional material weaknesses relating to the Restatements described below.
A control system, no matter how well conceived
and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further,
the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be
considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can
provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These
inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because
of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of
two or more people, or by management override of the controls. The design of any system of controls is also based in part upon
certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving
its stated goals under all potential future conditions.
Management’s Report on Internal Control over Financial
Reporting (As Restated)
Our management is responsible for establishing
and maintaining adequate internal control over financial reporting as that term is defined in Exchange Act Rules 13a-15(f) and
15d-15(f). Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP.
Because of its inherent limitations,
internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
Under the supervision and with the participation
of the Principal Executive Officer and the Vice President of Finance, management conducted an evaluation of the effectiveness of
its internal control over financial reporting as of April 30, 2015 and identified the following material weaknesses in internal
control over financial reporting:
| · | Ineffective corporate governance; |
| · | Ineffective communication of internal information; |
| · | Insufficient procedures and control documentation; |
| · | Insufficient segregation of duties; and |
| · | Insufficient information technology controls and documentation. |
As reported in the Original Filing,
because of these material weaknesses, the Principal Executive Officer and the Vice President of Finance concluded that, as
of April 30, 2015, our internal control over financial reporting was not effective based on the criteria outlined in Internal
Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission
(“COSO”).
In connection with the Restatements
discussed above under the caption “Explanatory Note” and in Note 1A to our Restated Financial Statements, management,
including our Principal Executive Officer and the Vice President of Finance, reassessed the effectiveness of our internal control
over financial reporting as of April 30, 2015 using the COSO criteria. Based on this reassessment, management has concluded that
we did not maintain effective internal control over financial reporting as of April 30, 2015, for the reasons previously identified
by management, as stated above, and because of material weaknesses relating to accounting for the Consultant Agreement, warrants,
certain issuances of shares of common stock and certain disclosures relating to issuances of options and common stock to directors
and officers, which necessitated the Restatements. These material weaknesses resulted in a material misstatement of our liabilities,
total stockholders’ equity, consolidated other income, consolidated general and administrative expenses and certain non-cash
compensation expenses set forth in our consolidated financial statements as of and for the year ended April 30, 2015 contained
in the Original Filing.
As reported in the Original Filing,
we have undertaken the process of implementing new procedures and controls in fiscal year 2016 and to review further our procedures
and controls in 2015. Although, we expect to make additional changes to our infrastructure and related processes that we believe
are also reasonably likely to strengthen and materially affect our internal control over financial reporting, we have not yet
made any such changes.
Prior to the remediation of these material
weaknesses, there remains risk that the processes and procedures on which we currently rely will fail to be sufficiently effective,
which could result in material misstatement of our financial position or results of operations and require a restatement. Moreover,
because of the inherent limitations in all control systems, no evaluation of controls-even where we conclude the controls are operating
effectively-can provide absolute assurance that all control issues, including instances of fraud, if any, have been detected. These
inherent limitations include the realities that judgments in decision-making can be faulty and breakdowns can occur because of
simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two
or more people, or by management override of the controls. The design of any system of controls also is based in part upon certain
assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its
stated goals under all potential future conditions. Over time, our control systems, as we develop them, may become inadequate because
of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent
limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected and could be
material to our financial statements.
The Certifications of our Principal
Executive and Financial Officer required in accordance with Rule 13a-14(a) under the Exchange Act and Section 302 of the
Sarbanes-Oxley Act of 2002 (“Certifications”) are attached to this Report. The disclosures set forth in this Item
9A contain information concerning: (i) the evaluation of our disclosure controls and procedures, and changes in internal control
over financial reporting, referred to in paragraph 4 of the Certifications; and (ii) material weaknesses in the design or operation
of our internal control over financial reporting, referred to in paragraph 5 of the Certifications. The Certifications should
be read in conjunction with this Item 9A for a more complete understanding of the matters covered by the Certifications.
The
effectiveness of our internal control over financial reporting as of April 30, 2015 has been audited by Farber Hass Hurley
LLP, an independent registered public accounting firm, as stated in their
report which is part of this Report. They have audited our consolidated financial statements and the effectiveness of our
internal control over financial reporting as of April 30, 2015. Their reports appear on page F-2 of this Report.
Changes in Internal Control over Financial Reporting
(As Restated)
There were no changes, other than those
detailed above under Management Report on Internal Control over Financial Reporting (including the material weaknesses
relating to the Restatements), in our internal control over financial reporting during the most recent fiscal quarter that
have materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM
To the Board of Directors and
Stockholders of Pharmacyte Biotech, Inc., formerly known
as Nuvilex, Inc.
We have audited Pharmacyte Biotech,
Inc., formerly known as Nuvilex, Inc.’s internal control over financial reporting as of April 30, 2015, based on criteria
established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of
the Treadway Commission (COSO). Pharmacyte Biotech, Inc.’s management is responsible for maintaining effective internal control
over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in
the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion
on the company’s internal control over financial reporting based on our audit.
We conducted our audit in accordance
with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform
the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all
material respects. Our audit of internal control over financial reporting included obtaining an understanding of internal control
over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating
effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered
necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A company’s internal control
over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance
with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance
with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the
financial statements.
Because of its inherent limitations,
internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
A material weakness is a control deficiency,
or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that
a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely
basis. The following material weaknesses have been identified and included in management’s assessment. The Company has an
insufficient number of personnel to adequately segregate internal controls over financial reporting. The Company does not have
adequate documentation of its internal controls and policies and procedures over financial reporting, including information technology
controls and procedures. The Company’s policies and procedures do not provide sufficient assurance that the Company’s
personnel will internally communicate financial and operational information on an accurate and timely basis. The Company’s
corporate governance structure does not provide sufficient oversight over the Company’s financial and operational key controls.
These material weaknesses were considered in determining the nature, timing, and extent of audit tests applied in our audit of
the 2015 consolidated financial statements, and this Report does not affect our report dated July 28, 2015, on those consolidated
financial statements.
In our opinion, because of the effect
of the material weaknesses described above on the achievement of the objectives of the control criteria, PharmaCyte Biotech, Inc.,
formerly known as Nuvilex, Inc. has not maintained effective internal control over financial reporting as of April 30, 2015, based
on criteria established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations
of the Treadway Commission (COSO).
We have also audited, in accordance
with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheet and the related
consolidated statements of operations, comprehensive loss, stockholders’ equity (Deficiency), and of cash flows of Pharmacyte
Biotech, Inc., formerly known as Nuvilex, Inc., and our report dated July 28, 2015, expressed an unqualified opinion.
/s/ Farber Hass Hurley LLP
Chatsworth, California
July 28, 2015
ITEM 9B. OTHER
INFORMATION
None.
PART II
ITEM 10. DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Our directors and executive officers
as of July 28, 2015, are as follows:
|
Age |
Position |
Kenneth L. Waggoner, JD |
67 |
Chairman of the Board, Chief Executive Officer, President and General Counsel |
Gerald W. Crabtree, PhD |
74 |
Director and Chief Operating Officer |
Richard Goldfarb, MD, FACS |
61 |
Director |
Thomas Liquard |
43 |
Director |
Kenneth L. Waggoner, JD
Kenneth L. Waggoner commenced employment with
us on September 1, 2013. He became our Chief Executive Officer and President on November 25, 2013. Shortly thereafter, Mr. Waggoner
assumed the additional position of General Counsel. Mr. Waggoner has over four decades of experience in management, business, operations
and the practice of law. It was his education, training, experience and leadership skills that led us to elect him to the Board
and appoint him Chairman.
Mr. Waggoner began his professional career
as an attorney in private practice. From 1986 to 2005, he was a senior partner with Brobeck, Phleger and Harrison, where he was
the Managing Partner of Brobeck’s Los Angeles office. Brobeck was named one of the top two law firms worldwide that provided
services to biotechnology clients including Chiron, Amgen, Biogen Idec, Sangamo, Ligand, DepoTech and many others. While at Brobeck,
Mr. Waggoner served as a member of the Executive Committee for almost ten years and on the Policy Committee for numerous years
managing Brobeck’s worldwide operations with annual revenues in excess of $750,000,000. Mr. Waggoner was the co-Chairman
of Brobeck’s worldwide Environmental Law Group.
Mr. Waggoner’s career included leadership
and legal positions with Fortune 100 companies most of his professional career. From 2005 to 2007, Mr. Waggoner served as the Vice
President and General Counsel of Chevron’s global downstream operations where he was responsible for the overall management
of legal services to the North American, Latin American, Europe and Asian Products Companies. While at Chevron, Mr. Waggoner led
the successful restructuring of Chevron’s global Legal Department following Chevron’s acquisition of Texaco.
From 2007 until 2013, Mr. Waggoner was the
principal of the Law Offices of Kenneth L. Waggoner & Associates. During that time he held leadership and legal positions with
several start-up companies and provided legal counsel and business advice to his clients.
Mr. Waggoner received his Juris Doctorate with
honors from Loyola University School of Law in Los Angeles in 1973.
Gerald W. Crabtree, PhD
Dr. Gerald W. Crabtree has served as
our Chief Operating Officer (“COO”) since February 2011 and is a member of the Board. Given the major importance to
developing treatments for cancer and diabetes coupled with Dr. Crabtree’s education, training and experience, Dr. Crabtree
was appointed to the Board.
Dr. Crabtree’s background in the
biomedical sciences has been substantial, having been involved with various biopharmaceutical companies where he has alternatively
supervised and coordinated the development of multiple drug candidates, prepared clinical protocols, investigator brochures, monographs,
and research and review articles.
A highlight of Dr. Crabtree’s
professional career was his tenure as Director of Project Planning and Management (Oncology and Immunology) at Bristol-Myers Squibb
(“BMS”) from 1990 to 1997. While at BMS, Dr. Crabtree established and directed a department that monitored and coordinated
the development of all oncologic and immunologic drugs from initial discovery through regulatory approval within BMS and served
as Project Manager for the development of the major anticancer agent, Taxol®, the “number one” drug
under development at BMS at that time. Taxol® ultimately became a multi-billion dollar drug for BMS and is still
widely used to treat a variety of cancers.
From 1989 to 1990, Dr. Crabtree was
Director of Pharmacology at Viratek, Inc., a subsidiary of ICN Pharmaceuticals, Inc. in Costa Mesa, California, where he worked
on the development of anticancer drugs first developed at the Nucleic Acid Research Institute (NARI, a joint venture between Eastman
Kodak and ICN Pharmaceuticals) and with ribavirin (Virazole®), Viratek’s landmark antiviral drug. Prior to
that, from 1985 to 1989, he served as Head of the Department of Molecular Pharmacology at NARI where his department was tasked
with elucidating the mechanisms of action of anticancer and antiviral drugs developed by NARI chemists. From 1970 to 1985, Dr.
Crabtree held several faculty positions at Brown University in Providence Rhode Island as well as at the Roger Williams Cancer
Center (“RWCC”) at that institution. These positions culminated in his attaining the rank of Associate Professor of
Medicine. During his time at Brown and the RWCC, Dr. Crabtree studied the mechanisms of action of putative anticancer and antiparasitic
drugs and participated in clinical trials of anticancer agents.
After leaving BMS in 1997, Dr. Crabtree
consulted with several biotech companies, all of which were developing cancer drugs or treatments. Then, from 2000 to 2003, Dr.
Crabtree served as Vice President of R&D at ETEX Corporation, a “device” company, where he was tasked with developing
that company’s proprietary calcium phosphate formulations as depot/delivery platforms for cancer drugs. Upon leaving ETEX,
he resumed his consulting business, which soon became focused on PhytoCeutica, Inc. located in the Yale Science Park in New Haven,
Connecticut, where he assisted in the preparation and review of FDA documents, clinical study protocols, investment acquisitions,
and contracts and business plans. PhytoCeutica was developing a traditional Chinese medicine four-herb combination as a treatment
for liver and pancreatic cancer. During his time with PhytoCeutica, Dr. Crabtree assumed ever-increasing responsibilities and from
2009 to 2010, ultimately serving as its Interim CEO. Dr. Crabtree resumed his consulting business after leaving PhytoCeutica until
he joined us.
Dr. Crabtree received his Ph.D. in Biochemistry
from the University of Alberta, Edmonton, Alberta, Canada, and has published over 80 articles in peer-reviewed journals. He was
a National Cancer Institute of Canada Research Fellow, is currently a member of both the American Society of Clinical Oncology
and the American Association for Cancer Research and has served on research grant review committees for the National Institutes
of Health and the American Cancer Society.
Dr. Crabtree has spent almost 50 years
working in academic, biotech and pharmaceutical companies with the majority of that vast experience being in the development of
drugs and treatments for cancer. He has held positions of ever-increasing importance over that time. In addition, over the past
few years, Dr. Crabtree has developed a significant knowledge base concerning diabetes and its treatments, because of his personal
health issues with that disease.
Richard Goldfarb, MD, FACS
Dr. Richard M. Goldfarb has served on
the Board since September 2005 when he was President of MedElite, Inc., a subsidiary of eFoodSafety.com.Inc., a predecessor of
PharmaCyte Biotech. In that capacity, Dr. Goldfarb brought Talsyn™ CI/bid scar cream into MedElite, Inc.’s product
portfolio. Since 2006, Dr. Goldfarb has been the owner and CEO of the Center for SmartLipo & Plastic Surgery and is also Medical
Director of Viora, a provider of aesthetic medical solutions. Dr. Goldfarb is the Medical Director of R&D at the FDA-approved
Bucks County Clinical research center in Pennsylvania. Dr. Goldfarb is also the medical director of Silhouette Lift and Selphyl.
Dr. Goldfarb has 20 years of surgical experience, including liposuction, and has been performing SmartLipo since its inception.
He was the first in Pennsylvania to receive the SmartLipo technology and has performed the most procedures in this area. In view
of his skill in performing this SmartLipo procedure, Cynosure has commissioned Dr. Goldfarb to travel throughout the country teaching
and training other physicians the SmartLipo surgical procedure.
Dr. Goldfarb obtained his M.D. degree from
the University of Health Sciences/Finch University, the Chicago Medical School, with honors in surgery. He completed his surgical
training at Northeastern Ohio College of Medicine. Dr. Goldfarb obtained additional training in cosmetic surgery at the University
of Pennsylvania, Department of Plastic Surgery. He also trained at Yale University and is a Member of the American Academy of Cosmetic
Surgeons. Dr. Goldfarb is Board Certified and a Fellow of the American College of Surgeons, the American Medical Association, the
Ohio State Medical Association and the Pennsylvania Medical Society. He is also a member of the American Academy of Cosmetic Physicians.
During his tenure on the Board, Dr. Goldfarb
has seen us transition from a nutraceutical company to its present position as a biotechnology company. In addition to his proficiency
as a surgeon, Dr. Goldfarb has significant interest and experience with all forms of cancer and its treatments. Based upon his
education, training, experience, we appointed Dr. Goldfarb to the Board.
Thomas Liquard
Thomas Liquard was appointed to the
Board on April 27, 2015. Mr. Liquard has more than a decade of experience in the pharmaceutical industry, having held various commercialization,
product development and leadership roles with big pharma and biotech companies. From 2013 to 2014, Mr. Liquard was COO then
CEO of Alchemia Limited (Alchemia), a major Australian biotech company (ASX: ACL) with an FDA-approved sterile injectable and a
late stage oncology platform. During that time, Mr. Liquard administered an AU$ 25 million budget and Alchemia had revenues of
AU$ 15 million. While at Alchemia, Mr. Liquard rebuilt that company’s valuation which had lost 23% after the departure of
the prior CEO, brought two major investors into the register, improved its stock price to a 52-week high and led all business development
and corporate development activities.
Prior to joining Alchemia, Mr. Liquard
spent seven years with Pfizer, Inc. (Pfizer) in New York, where he held various commercial roles of increasing scope and responsibility,
including most recently as Senior Director, Portfolio Development Leader and Emerging Markets for the Established Products portfolio. In
that role, Mr. Liquard drove business development (M&A, licensing, partnerships) and internal product development initiatives
and managed more than 70 opportunities at various stages of execution. During his tenure at Pfizer, Mr. Liquard also spent three
years as a key member of the company’s Established Products US Brands P&L Leadership Team where he engineered the group’s
505(b)(2) investment strategy, culminating in the $700M acquisition of NextWave Pharmaceuticals, Inc. (NextWave). He also
led the NextWave pre- and post- acquisition integration efforts. In addition, Mr. Liquard worked as a Director within the New Product Planning
and Portfolio & Decision Analysis groups at Pfizer from 2007 to 2010. There he was responsible for formulating investment decisions
on business development opportunities and internal development programs across multiple therapeutic areas including oncology and
metabolic diseases, including diabetes and central nervous system.
From 2004 to 2007, Mr. Liquard served
as Senior Consultant to the Frankel Group, where he specialized in the life sciences. While at the Frankel Group, Mr. Liquard was
lead consultant for global “war-gaming” in support of a $3.0 billion supportive care biologic, facilitated multiple
competitive planning sessions in the United States, Europe and Canada and performed due diligence analyses on multiple potential
in-licensing targets. Mr. Liquard holds an MBA from Columbia Business School and a Bachelor of Science degree from the University
of Southern California.
Mr. Liquard was appointed to the Board
because of his experience and expertise in leading positions with life science-oriented biotech and big pharma companies. In particular,
his 7-year tenure with Pfizer, one of the world’s leading pharmaceutical companies, where he played leading roles in the
development of that company’s portfolio development was believed to be a much needed asset to us.
Compliance with Section 16(a) of the Exchange Act
We do not have a class of securities
registered pursuant to Section 12 of the Exchange Act. Accordingly, our executive officers and directors and our investors who
own more than 10% of their equity securities are not subject to the beneficial ownership reporting requirements of Section 16(a)
of the Exchange Act.
Family Relationships
There are no family relationships among
our executive officers, directors and significant employees. As of April 30, 2015, our personnel do not have any involvement in
legal proceedings requiring disclosure pursuant to the Rules and Regulations of the Commission.
Corporate Governance
The corporate governance as of April
30, 2015 includes Board meetings which are run by the Board, with Kenneth L. Waggoner as Chairman of the Board and Secretary leading
the meetings. Directors include Mr. Waggoner, Dr. Crabtree, Dr. Goldfarb and Mr. Liquard.
Board Leadership Structure
Our Board has a chairman, currently
Mr. Waggoner, who has authority, among other things, to call and preside over board meetings, to set meeting agendas and to determine
materials to be distributed to the Board. Accordingly, the chairman has substantial ability to shape the work of the Board.
The positions of Chief Executive Officer
and Chairman of our Board are held by the same person. The Chairman of our Board chairs director and stockholder meetings and participates
in preparing their agendas. Mr. Waggoner, as our Chief Executive Officer, also serves as a focal point for communication between
management and the Board between Board meetings, although there is no restriction on communication between directors and management.
We believe that our current leadership
structure is appropriate, as the Board considers all of its members equally responsible and accountable for oversight and guidance
of its activities.
Board Committees
Our Board has formed an Audit Committee
pursuant to the NASDAQ Listing Rules and is in the process of forming a Nominating Committee and a Compensation Committee in accordance
with those same Rules. Charters for each Committee have been adopted by the Board.
Board Practices
Our business and affairs are managed
under the direction of our Board. The primary responsibilities of our Board are to provide oversight, strategic guidance, counseling
and direction to our management.
Policy Regarding Board Attendance
Our directors are expected to attend
meetings of the Board as frequently as necessary to properly discharge their responsibilities and to spend the time needed to
prepare for each such meeting. Our directors are expected to attend annual meetings of stockholders, but we do not have a formal
policy requiring them to do so.
Shareholder Communications
We have a process for shareholders who
wish to communicate with our Board. Shareholders who wish to communicate with our Board may write to it at our address given above.
These communications will be reviewed by one or more of our employees designated by our Board, who will determine whether they
should be presented to our Board. The purpose of this screening is to allow the Board to avoid having to consider irrelevant or
inappropriate communications.
Code of Business Conduct and Ethics
On September 19, 2014, our Board adopted
a Code of Business Conduct and Ethics. This can be found on our website at www.pharmacyte.com and in Exhibit 14.1 to this Report.
ITEM 11. EXECUTIVE
COMPENSATION
The following table sets forth information
about all cash and non-cash compensation awarded to, earned by, or paid to: (i) all persons serving as our principal executive
officer during the last two fiscal years; (ii) all persons serving as our principal financial officer during the last two fiscal
years; (iii) our three most highly compensated executive officers (other than principal executive officer and principal financial
officer) serving as such at the end of the last two fiscal years; and (iv) up to two additional persons for whom disclosure would
have been provided pursuant to clause (iii) above but for the fact that the person was not serving as our executive officer at
the end of the last fiscal year, and each current director during fiscal years ended April 30, 2015 , 2014 and 2013. There were
no other forms of compensation provided to our directors or officers in the form of health or life insurance benefits, options
plans, car or other allowances or key-man life insurance that are not shown in the Summary Officer Compensation Table below.
Summary Officer Compensation Table
Officers:
Name | |
Principal Position | | |
Fiscal Year Ended April 30, | | |
Salary ($) | | |
Stock Awards Shares | | |
Stock Value ($) | | |
Option Awards ($) | | |
Total ($) | |
Kenneth L. Waggoner | |
Chief Executive Officer, | | |
| 2015 | | |
$ | 150,000 | | |
| 2,200,000 | | |
$ | 450,150 | | |
$ | 778,172 | | |
$ | 1,378,322 | |
| |
President
and | | |
| 2014 | | |
$ | 50,000 | | |
| 10,000,000 | | |
$ | 3,180,000 | | |
| | | |
$ | 3,230,000 | |
| |
General Counsel | | |
| 2013 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Patricia Gruden | |
Former Chief | | |
| 2015 | | |
$ | 72,000 | | |
| | | |
| | | |
| | | |
$ | 72,000 | |
| |
Financial Officer | | |
| 2014 | | |
$ | 34,000 | | |
| 10,000,000 | | |
$ | 3,180,000 | | |
| | | |
$ | 3,214,000 | |
| |
| | |
| 2013 | | |
| | | |
| 150,000 | | |
$ | 4,200 | | |
| | | |
$ | 4,200 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Gerald W. Crabtree, PhD | |
Chief Operating Officer | | |
| 2015 | | |
$ | 140,000 | | |
| 1,100,000 | | |
$ | 242,860 | | |
$ | 778,172 | | |
$ | 1,161,032 | |
| |
| | |
| 2014 | | |
$ | 59,830 | | |
| 10,800,000 | | |
$ | 3,338,380 | | |
| | | |
$ | 3,398,210 | |
| |
| | |
| 2013 | | |
$ | 17,500 | | |
| 240,000 | | |
$ | 13,900 | | |
| | | |
$ | 31,400 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Timothy Matula | |
Former President of | | |
| 2015 | | |
$ | 87,000 | | |
| | | |
| | | |
| | | |
$ | 87,000 | |
| |
Viridis Biotech | | |
| 2014 | | |
| | | |
| 10,000,000 | | |
$ | 3,180,000 | | |
| | | |
$ | 3,180,000 | |
| |
| | |
| 2013 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Robert R. Ryan, PhD | |
Former Chief Scientific | | |
| 2015 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
Officer Former Chief | | |
| 2014 | | |
$ | 35,000 | | |
| 800,000 | | |
$ | 102,080 | | |
| | | |
$ | 137,080 | |
| |
Executive Officer and President | | |
| 2013 | | |
| | | |
| 7,780,000 | | |
$ | 360,544 | | |
| | | |
$ | 360,544 | |
On March 24, 2014, our Board granted Mr. Waggoner 10,000,000
shares of our common stock for his extraordinary efforts and time commitment related to the successful growth and development
of the Company and Viridis Biotech since he joined us. The stock grant was provided on the condition that Mr. Waggoner enter into
an Executive Compensation Agreement (“Waggoner Compensation Agreement”) requiring him to: (i) stay employed by us
on a full-time basis in his current positions of Chief Executive Officer, President and General Counsel; (ii) assume the new positions
of Chief Executive Officer and General Counsel of Viridis Biotech; and (iii) become our director, unless extenuating circumstances
require that he withdraw from these full-time positions, at which time Mr. Waggoner will be obligated to remain our consultant
for the duration of the term of the Waggoner Compensation Agreement. Among other provisions, the Waggoner Compensation Agreement
is to have a term of two years and contain an appropriate “anti-dilution” provision with respect to the shares granted
to Mr. Waggoner. The specific terms and conditions of the Waggoner Compensation Agreement are to be negotiated, documented and
approved by the Board.
On March 24, 2014, our Board granted
Mrs. Gruden 10,000,000 shares of our common stock for her extraordinary efforts and time commitment since 2011 and anticipated
contribution to our success in the future. The stock grant was provided on the condition that Mrs. Gruden enter into an Executive
Compensation Agreement (“Gruden Compensation Agreement”) requiring that she stay employed by us on a full-time basis
in her current positions of Chairman of the Board and Chief Financial Officer, unless extenuating circumstances require that she
withdraw from full-time employment, at which time she will be obligated to remain as our consultant for the duration of the term
of the Gruden Compensation Agreement. Among other provisions, the Gruden Compensation Agreement will have a term of two years and
contain an appropriate “anti-dilution” provision with respect to the shares granted to Mrs. Gruden. The specific terms
and conditions of the Gruden Compensation Agreement are to be negotiated, documented and approved by the Board.
On March 24, 2014, our Board granted
Dr. Crabtree 10,000,000 shares of our common stock for his extraordinary efforts and time commitment related to the successful
growth and development of the Company and Viridis Biotech since he joined us. The stock grant was provided on the condition that
Dr. Crabtree enter into an Executive Compensation Agreement (“Crabtree Compensation Agreement”) requiring that he stay
employed by us on a full-time basis in his current positions as the Chief Operating Officers and Viridis Biotech and as our director,
unless extenuating circumstances require that he withdraw from these full-time positions, at which time Dr. Crabtree will be obligated
to remain our consultant for the duration of the term of the Crabtree Compensation Agreement. Among other provisions, the Crabtree
Compensation Agreement will have a term of two years and contain an appropriate “anti-dilution” provision with respect
to the shares granted to Dr. Crabtree. The specific terms and conditions of the Crabtree Compensation Agreement are to be negotiated,
documented and approved by the Board.
On March 24, 2014, our Board granted
Mr. Matula 10,000,000 shares of our common stock for his extraordinary efforts and time commitment since 2011 and anticipated contribution
to the our success in the future. The stock grant was provided on the condition that Mr. Matula enter into an Executive Compensation
Agreement (“Matula Compensation Agreement”) requiring that he stay employed by us on a full-time basis in his current
position as President of Viridis Biotech, remain our director and assume the new position of Chief Strategist, unless extenuating
circumstances require that he withdraw from full-time employment for us, at which time he will be obligated to remain as our consultant
for the duration of the term of the Matula Compensation Agreement. Among other provisions, the Matula Compensation Agreement will
have a term of two years and will contain an appropriate “anti-dilution” provision with respect to the shares granted
to Mr. Matula. The specific terms and conditions of the Matula Compensation Agreement are to be negotiated, documented and approved
by the Board.
We did not pay or accrue any other compensation,
in the form of bonus, stock awards, option awards, incentive plan compensation or nonqualified deferred compensation earnings to
any executive officer for services as an executive officer during the fiscal years ended April 30, 2015 and 2014; neither were
there any prerequisites or other personal benefits. We do not have any option plan, equity incentive plan or retirement plan at
the present time.
Employment Arrangements
Dr. Robert F. Ryan
The following sets forth a summary of
an oral agreement, a Memorandum of Understanding (“MOU”), an employment agreement (“Employment Agreement”)
our Board resolutions with respect to the employment of Dr. Ryan.
In January of 2011, we employed Dr.
Ryan as our President and Chief Executive Officer. We agreed to pay an indeterminate amount of compensation based upon the availability
of funds from the efforts of Dr. Ryan to raise $5.0 million he committed to raise when he became employed. That compensation was
to include the issuance of shares of our common stock based upon Dr. Ryan’s performance. It was agreed between the parties
to defer developing the factors necessary to determine the amount of cash and share compensation until sufficient funds had been
raised by Dr. Ryan. This agreement was oral.
Commencing February 1, 2011 and ending
January 31, 2012, Dr. Ryan served as our President and Chief Executive Officer. There is a MOU with Dr. Ryan, dated January 31,
2011. Under the MOU compensation was composed of two parts: Part 1. For joining us, Dr. Ryan was issued 6,000,000 shares of restricted
stock and 500,000 shares on a monthly basis earned on the first day of each respective month with us; Part 2. In lieu of a standard
salary, Dr. Ryan was paid 250,000 restricted shares on a monthly basis earned on the last day of each respective month on a monthly
basis from February through May 2011 and 415,000 shares each month starting June 1, 2011 through the end of the term of the MOU.
There was no cash component of his salary. In addition, we provided four incentives: Part 1. We offered Dr. Ryan the following
performance-based incentives as a supplement to his income: 3,000,000 restricted shares of common stock upon completion of the
acquisition of SG Austria or a related entity by us; Part 2. 2,000,000 restricted shares of common stock upon completion of the
acquisition of another comparable company earned at the Closing of the acquisition; Part 3. 1,000,000 restricted shares of common
stock upon completion of the acquisition of a third comparable company or through the arrangement of a distribution channel where
sales are imminent or sales to any entity where the sales are anticipated to be greater than $50,000; Part 4. 1,000,000 restricted
shares of common stock for the commercialization of Oraphyte, Citroxin, or another of the company’s products from the existing
product line or addition of any other entity to us. These shares are deemed to have been earned at either the sale of the product
to a third party, or through the arrangement of a distribution channel where sales are imminent or sales to any entity where the
sales are anticipated to be greater than $50,000; Part 4: 1,000,000 restricted shares for the completion of any major event, such
as, but not limited to, the following: an IND filing and issuance, clinical trial initiation or completion, a NDA filing, a NDA
approval, commercialization or monetization of any new product or acquisition of additional products or companies.
On January 9, 2012, Dr. Ryan assumed
the position of Chief Financial Officer upon the receipt of the resignation from Patricia Gruden, our then Chief Financial Officer.
There was no Board approval for Dr. Ryan assuming this position.
There is an Employment Agreement with
Dr. Ryan dated January 31, 2012. Pursuant to the provisions of the Employment Agreement: (i) the term was from February 1, 2012
through January 31, 2016; (ii) Dr. Ryan will continue to receive 415,000 shares of restricted common stock per month as temporary
salary as President and CEO with no cash component through the compensation term; (iii) in lieu of a standard salary as CFO, if
there is no new person to take on the position of CFO by July 31, 2012, commencing on August 1, 2012, Dr. Ryan would receive 350,000
restricted shares of common stock each month; (iv) performance incentives shall remain as provided previously unless changed by
the Board; (v) a permanent salary of $120,000 shall be provided starting upon completion of the acquisition of Austrianova or another
entity plus 2,980,000 shares stock per year; (v) an annual bonus based on performance shall be given in conjunction with achievement
of objectives set by us and Dr. Ryan; (vi) a failure to renew the agreement at the end of the term regardless of reason shall be
treated as a termination by us without cause; (vii) upon our termination of Dr. Ryan’s employment without cause or by Dr.
Ryan with good reason, we are to pay Dr. Ryan his base salary for one year following the termination plus the previous year’s
annual bonus payment; (viii) in the event we terminate Dr. Ryan’s employment with cause or Dr. Ryan resigns, we are to pay
Dr. Ryan his then current base salary for one year; and (ix) in the event that the agreement is terminated pursuant to a change
in control, Dr. Ryan shall receive a severance payment equal to 24 months of benefits and bonuses to be calculated at the time
of termination.
On February 12, 2012, our Board elected
Dr. Robert F. Ryan to be a member of the Board.
On May 1, 2013, by Unanimous Written
Consent of our Board (“May 1, 2013 BOD Consent”), our Board resolved that, commencing July 1, 2013 and continuing until
April 30, 2017 or until it reconvenes and establishes new compensation terms, we will pay Dr. Ryan: (i) a salary of $60,000 per
year at the rate of $5,000 per month; (ii) 2,400,000 restricted shares of our common stock per year payable in the amount of 200,000
shares per month; and (iii) an increase in his monthly salary to $10,000 per month for an annual salary of $120,000 upon the commencement
of clinical trials of our “Cell-in-a-Box®” technology.
During May of 2014, a dispute arose
between us and Dr. Ryan relating to: (i) the validity, authenticity and approval of the MOU and the Employment Agreement; (ii)
the circumstances surrounding our issuance of stock and compensation to Dr. Ryan; and (iii) Dr. Ryan’s entitlement to the
compensation previously paid and described in the various purported agreements. Shortly thereafter, we placed Dr. Ryan on a leave
of absence with pay pending the completion of our investigation. We undertook an investigation into the facts relating to these
issues.
On May 14, 2014, our Board adopted a
resolution to eliminate any further accrual of Dr. Ryan’s shares pursuant to a Board resolution and continued his leave of
absence with pay pending the completion of our review into Dr. Ryan’s activities.
Effective as of September 19, 2014,
Dr. Ryan resigned from our Board and from his position as our Chief Scientific Officer. In connection with his departure, we entered
into the Settlement Agreement pursuant to which we agreed to pay Dr. Ryan $183,000 in settlement of certain loans and expenses,
transfer certain assets to Dr. Ryan under the terms of the Asset Purchase Agreement and allow Dr. Ryan to retain 26,036,800 shares
of our common stock earned and purchased. Under the Settlement Agreement, Dr. Ryan agreed to surrender certain share certificates
of us and of Bio Blue Bird AG, resign from all of his positions with us, return all our property and data in his possession and
release us from all claims of any type or description. In addition, Dr. Ryan agreed to abide by certain limitations on the transfer
of his shares of our common stock. Upon the execution of the Settlement Agreement, Dr. Ryan may sell up to 1,250,000 shares, except
that he may not sell any shares for a price that is more than $0.02 less than the closing price of the shares on the previous trading
day. Apart from these 1,250,000 shares of his common stock, on any given day Dr. Ryan may not sell any more than 30,000 shares
plus an additional 15,000 shares for each 1,000,000 shares reported traded (rounded down to the nearest million) on the immediately
previous trading day. The Asset Purchase Agreement provides for the sale of listed nutraceutical assets to Dr. Ryan in exchange
for his execution of the Settlement Agreement and his assumption of certain obligations.
Kenneth L. Waggoner, JD
In September of 2013, we employed Mr.
Waggoner as an employee and agreed to commence paying him an annual salary of $60,000, payable in the amount of $5,000 per month.
In addition, we agreed to pay Mr. Waggoner 1,200,000 restricted shares of our common stock annually, payable at the rate of 100,000
shares per month as additional compensation subject to review and increase at our discretion. On April 1, 2014, we increased Mr.
Waggoner’s annual salary to $120,000, payable in the amount of $10,000 per month. On July 1, 2014, we increased Mr. Waggoner’s
annual salary to $156,000, payable in the amount of $13,000 per month.
On March 11, 2015, effective as of January
1, 2015, we entered into the Waggoner Compensation Agreement. The Waggoner Compensation Agreement is for a term of two years with
annual extensions thereof unless we or Mr. Waggoner provide 90 days written notice of termination. The Agreement provides that
Mr. Waggoner will be employed as a member of our Board, as our Chief Executive Officer, President and General Counsel and as the
Chief Executive Officer and General Counsel of Viridis Biotech. Mr. Waggoner will be paid a base salary of $180,000 subject to
annual increases in the discretion of our Compensation Committee.
As discussed above, subject to Mr. Waggoner
entering into the Waggoner Compensation Agreement, in March of 2014, our Board granted Mr. Waggoner 10,000,000 shares of our common
stock. On March 11, 2015, Mr. Waggoner was granted 2,400,000 additional shares of our common stock vesting at the rate of 600,000
shares per quarter with an identical grant to be made on January 1, 2016. Further, and as previously disclosed and subject to Mr.
Waggoner entering into the Waggoner Compensation Agreement, on March 11, 2015, Mr. Waggoner was granted a stock option to purchase
up to 10,000,000 shares of common stock at a price of $0.11 per share, the fair market value on the date of grant, and on March
11, 2015, was granted a second stock option to purchase up to 2,400,000 shares at a price of $0.11 per share, the fair market value
on the date of grant, with vesting at the rate of 200,000 shares per month. On January 1, 2016, Mr. Waggoner will be granted another
stock option to purchase up to 2,400,000 shares at the fair market value on the date of grant with the same vesting schedule.
Dr. Gerald W. Crabtree
In February of 2011, we employed Dr.
Crabtree as our Chief Operating Officer. We agreed to pay an indeterminate amount of compensation based upon the availability of
funds from the efforts of Dr. Ryan to raise $5.0 million he committed to raise when he became employed. That compensation was to
include the issuance of shares of our common stock based upon Dr. Crabtree’s performance. It was agreed between the parties
to defer developing the factors necessary to determine the amount of cash and share compensation until sufficient funds has been
raised by Dr. Ryan. This agreement was oral.
Pursuant to the May 1, 2013 BOD Consent,
our Board resolved that, commencing September 1, 2013 and continuing until April 30, 2017 or until it reconvenes and establishes
new compensation terms, we will pay Dr. Crabtree: (i) a salary of $60,000 per year at the rate of $5,000 per month; (ii) 1,200,000
shares of our restricted common stock per year payable in the amount of 100,000 shares per month; and (iii) an increase in his
monthly salary to $7,500 per month for an annual salary of $90,000 upon the commencement of clinical trials of our “Cell-in-a-Box®”
technology.
On April 1, 2014, we increased Dr. Crabtree’s
annual salary to $120,000, payable in the amount of $10,000 per month. On July 1, 2014, we increased Dr. Crabtree’s annual
salary to $156,000, payable in the amount of $13,000 per month.
On March 11, 2015, effective as of January
1, 2015, we entered into the Crabtree Compensation Agreement. The Crabtree Compensation Agreement is for a term of two years with
annual extensions thereof unless we or Dr. Crabtree provide 90 days written notice of termination. The Crabtree Compensation Agreement
provides that Dr. Crabtree will be employed as a member of our Board, as our Chief Operating Officer and as the Chief Operating
Officer of Viridis Biotech. Dr. Crabtree will be paid a base salary of $156,000 subject to annual increases in the discretion of
our Compensation Committee.
As discussed above, subject to Dr. Crabtree
entering into the Crabtree Compensation Agreement, in March of 2014, our Board granted Dr. Crabtree 10,000,000 shares of our common
stock. On March 11, 2015, Dr. Crabtree was granted an additional 1,200,000 shares of our common stock vesting at the rate of 300,000
shares per quarter with an identical grant to be made on January 1, 2016. Further, as previously disclosed and subject to Dr. Crabtree
entering into the Crabtree Compensation Agreement, on March 11, 2015, Dr. Crabtree was granted a stock option to purchase up to
10,000,000 shares of Common Stock at a price of $0.11 per share, the fair market value on the date of grant, and on March 11, 2015,
was granted a second stock option to purchase up to 2,400,000 shares at a price of $0.11 per share, the fair market value on the
date of grant, with vesting at the rate of 200,000 shares per month. On January 1, 2016, Dr. Crabtree will be granted another stock
option to purchase up to 2,400,000 shares at the fair market value on the date of grant with the same vesting schedule.
Patricia Gruden
Prior to April 1, 2014, Mrs. Gruden
was not employed by us even though she periodically worked as our Chief Financial Officer. Mrs. Gruden did not work for us in accordance
with an agreement that specified the terms of her employment. She was, however, compensated as the Chairman and member of our Board.
Her compensation was set in accordance with our policy in compensating all of our directors at the time. As described above, previously
our Board did not set a fixed compensation fee for directors; instead, it reviewed individual director performance on an annual
basis. Compensation was earned on a merit-system based upon a review of the preceding year’s performance.
On April 1, 2014, we employed Mrs. Gruden
as an employee at an annual salary annual salary to $120,000, payable in the amount of $10,000 per month. On July 1, 2014, we increased
Mrs. Gruden’s annual salary to $156,000, payable in the amount of $13,000 per month.
Effective October 1, 2014, Mrs. Gruden
resigned as our Chief Financial Officer, Treasurer, Secretary, Board member and employee.
Tim Matula
Prior to April 1, 2014, Tim Matula was
not employed by us even though he periodically worked for Viridis Biotech, then known as Medical Marijuana Sciences. He was, however,
compensated as a member of our Board. His compensation was set in accordance with our policy in compensating all of our directors
at the time. As described above, the Board previously did not set a fixed compensation fee for directors; instead, it reviewed
individual director performance on an annual basis. Compensation was earned on a merit-system based upon a review of the preceding
year’s performance.
On April 1, 2014, we employed Mr. Matula
as an employee at an annual salary annual salary to $120,000, payable in the amount of $10,000 per month. On July 1, 2014, we increased
Mr. Matula’s annual salary to $156,000, payable in the amount of $13,000 per month.
Effective October 1, 2014, Mr. Matula
resigned as the President of Medical Marijuana Sciences, Inc., Board member and employee of us.
Director Compensation
The following table sets forth certain
information concerning compensation paid or accrued to our directors during the year ended April 30, 2015.
Summary Compensation Table
Directors:
Name | |
Principal Position | | |
Fiscal Year Ended April 30, | | |
Salary ($) | | |
Stock Awards Shares | | |
Stock Value ($) | | |
Option Awards ($) | | |
Total ($) | |
Kenneth L. Waggoner | |
Chairman of the Board | | |
| 2015 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | |
| 2014 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | |
| 2013 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Patricia Gruden | |
Former Chairman of | | |
| 2015 | | |
$ | 30,000 | | |
| | | |
| | | |
$ | 1,451,893 | | |
$ | 1,481,893 | |
| |
the Board | | |
| 2014 | | |
| | | |
| 1,500,000 | | |
$ | 144,000 | | |
| | | |
$ | 144,000 | |
| |
| | |
| 2013 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Gerald W. Crabtree, PhD | |
Director | | |
| 2015 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | |
| 2014 | | |
| | | |
| 500,000 | | |
$ | 48,000 | | |
| | | |
$ | 48,000 | |
| |
| | |
| 2013 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Robert Bowker | |
Former Director | | |
| 2015 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | |
| 2014 | | |
| | | |
| 500,000 | | |
$ | 48,000 | | |
| | | |
$ | 48,000 | |
| |
| | |
| 2013 | | |
$ | 90,000 | | |
| 3,500,000 | | |
$ | 98,000 | | |
| | | |
$ | 188,000 | |
| |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Richard Goldfarb, MD | |
Director | | |
| 2015 | | |
$ | 9,000 | | |
| | | |
| | | |
$ | 725,946 | | |
$ | – | |
| |
| | |
| 2014 | | |
| | | |
| 500,000 | | |
$ | 48,000 | | |
| | | |
$ | 48,000 | |
| |
| | |
| 2013 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Timothy Matula | |
Former Director | | |
| 2015 | | |
$ | 10,000 | | |
| | | |
| | | |
$ | 1,451,893 | | |
$ | 1,461,893 | |
| |
| | |
| 2014 | | |
$ | 20,000 | | |
| 4,500,000 | | |
$ | 432,000 | | |
| | | |
$ | 452,000 | |
| |
| | |
| 2013 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Robert R. Ryan, PhD | |
Former Director | | |
| 2015 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | |
| 2014 | | |
| | | |
| 500,000 | | |
$ | 48,000 | | |
| | | |
$ | 48,000 | |
| |
| | |
| 2013 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Thomas Liquard | |
Director | | |
| 2015 | | |
$ | 9,000 | | |
| | | |
| | | |
$ | 34,685 | | |
$ | 43,685 | |
| |
| | |
| 2014 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
| |
| | |
| 2013 | | |
| | | |
| | | |
| | | |
| | | |
$ | – | |
Members of our Board were previously
compensated for performance of their duties as directed by the Chairman of the Board. Until April 27, 2015, the Board had not set
a fixed compensation plan for directors, but chose to review Board and individual director performance on an annual basis with
Board compensation being earned on a merit-system. Effective April 27, 2015, the Board approved a compensation plan for directors
Mr. Liquard and Dr. Goldfarb. The plan commenced April 1, 2015 and continues until resignation or removal or until a success director
is duly elected and qualified. Mr. Liquard is to receive $9,000 per quarter on a pro-rated basis for periods of less than a quarter.
In addition, Mr. Liquard received an option to purchase 250,000 shares of our common stock at an exercise price equal to the fair
market value of our common stock on the date of the grant of the option. Dr. Goldfarb is to receive 9,000 per quarter on a pro-rated
basis for period of less than a quarter. Board compensation for Mr. Waggoner and Dr. Crabtree are included in their Executive Compensation
Agreement.
ITEM 12. SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The following table sets forth as of
April 30, 2015, certain information with respect to the beneficial ownership of our common stock by each person known by us to
be the beneficial owner of more than five percent (5%) of our common stock, by each of our directors, by each of our named executive
officers and by all executive officers and directors as a group.
Name and Address |
Number of Shares
Beneficially Owned (1) |
Percentage of
Common Stock (1) |
Kenneth L. Waggoner, JD, Chairman of the Board, Chief Executive Officer, President and General Counsel |
13,500,000 |
1.84% |
Patricia Gruden, Former Chairman of the Board and Chief Financial Officer |
(2) |
|
Gerald W. Crabtree, PhD, Chief Operating Officer and Board Member |
12,600,000 |
1.72% |
Robert Bowker, Board Member |
(3) |
|
Richard Goldfarb, MD, FACS, Board Member |
15,920,000 |
2.17% |
Timothy Matula, Former President of Viridis Biotech and Board Member |
(4) |
|
Robert F. Ryan, PhD, Former Chief Scientific Officer and Board Member |
(5) |
|
All directors and executive officers as a group (7 persons) |
42,020,000 |
5.73% |
| (1) | Percentages based on 732,760,536 shares of common stock issued and outstanding as of April 30,
2015. |
| (2) | Effective October 1, 2014, Mrs. Gruden resigned. We believe that Mrs. Gruden has sold some of the
shares she was awarded during her tenure with us. We have no information as to the number of shares she has sold. |
| (3) | Effective October 1, 2014, Mr. Bowker resigned. We believe that Mr. Bowker has sold some of the
shares he was awarded during his tenure with us. We have no information as to the number of shares he has sold. |
| (4) | Effective October 1, 2014, Mr. Matula resigned. We believe that Mr. Matula has sold some of the
shares he was awarded during his tenure with us. We have no information as to the number of shares he has sold. |
The address of all beneficial owners
is 12510 Prosperity Drive, Suite 310, Silver Spring, Maryland 20904. Each person has sole voting and investment power with respect
to the shares of common stock.
We are not aware of any arrangement,
the operation of which may, at a subsequent date, result in change in control. There are no provisions in our governing instruments
that could delay a change in control.
ITEM 13. CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
We had the following related party transactions:
As of April 30, 2015, 2014 and 2013, we owed
Berkshire Capital $0, $0 and $393,158, respectively, for operating expenses. Berkshire Capital was, at certain times when such
amounts were outstanding, the holder of more than 5% of our outstanding shares of common stock. The highest amount outstanding
during the fiscal year ended April 30, 2013 and 2014 were $393,158 and $471,011, respectively. All loans bear interest at 6% and
were due within one to three years. During the fiscal year ended April 30, 2013, we did not make any payments on these loans. During
the fiscal year ended April 30, 2014, we repaid $471,011 of principal and $30,195 in accrued interest with the issuance of 26 million
shares of common stock.
As of April 30, 2015, 2014 and 2013, we owed
our Chief Financial Officer and Chairman of the Board, Patricia Gruden, $0, $0 and $23,200 in principal and $2,740 in interest,
for a total of $25,940; respectively, for a loan she made to us in 2011. The loan bears interest at 8% and is due on demand. The
highest amount outstanding during the fiscal year ended April 30, 2013 was $25,940. During the year ended April 30, 2014, we paid
the outstanding principal balance of $23,200 and accrued interest of $4,117.
As of April 30, 2013, we owed Dr. Robert F.
Ryan, our former Chief Scientific Officer and former Chief Executive Officer, $201,143 of principal and $20,171 of accrued interest
on a loan that is due on demand and accruing interest at 8% per year. The highest amount outstanding occurred during the fiscal
year ended April 30, 2013 and totaled $283,743. During the year ended April 30, 2013, we made principal payments totaling $95,600
and no interest payments in respect of this loan. During the year ended April 30, 2014, we repaid $35,095 of principal in cash
and converted $25,920 of principal to common stock. No payments were made towards accrued interest. As of April 30, 2014, the balance
on this loan was $140,143 of principal and $33,960 of accrued interest. Subsequent to April 30, 2014, we repaid an additional $20,000
of principal. Effective as of September 19, 2014, Dr. Ryan resigned from the Board and from his position as our Chief Scientific
Officer. In connection with his departure, we entered into the Settlement Agreement pursuant to which we paid Dr. Ryan $183,000
in settlement of the full amount of his loan.
During the year ended April 30, 2015, we issued
stock options to directors and officers (see Note 8 of the consolidated financial statements).
With the exception of Mr. Liquard, our Board
has determined that none of our directors satisfies the definition of an “Independent Director” as established in the
NASDAQ Marketplace Rules. Mr. Liquard has been determined by our Board to be an Independent Director.
ITEM 14. PRINCIPAL
ACCOUNTANT FEES AND SERVICES
A summary of the fees billed by our
former independent auditor, Robison, Hill & Company, PC for professional services rendered for fiscal year ended April 30,
2014 and through the period ended January 30, 2015, is set forth below. A summary of the fees billed by the our current independent
auditor, Farber Hass Hurley LLP, for professional services rendered for fiscal year ended April 30, 2015, is also set forth below.
Service | |
2015 | | |
2014 | |
Audit Fees | |
$ | 40,000 | | |
$ | 31,500 | |
Quarterly Review Fees | |
$ | 23,750 | | |
$ | 20,165 | |
Tax Fees | |
$ | 6,500 | | |
$ | 5,500 | |
All Other Fees | |
$ | – | | |
$ | – | |
Total | |
$ | 70,250 | | |
$ | 57,165 | |
Our Chief Executive Officer and our
Vice President of Finance pre-approve all services to be performed by our independent auditor. All of the services listed above
have been pre-approved by them.
ITEM 15. EXHIBITS (AS RESTATED)
(a) Documents filed as part of this
Report:
(1) Financial Statements.
Our consolidated financial statements
and schedule and consolidated notes thereto as of April 30, 2015, 2014 and 2013, and for each of the three years in the period
ended April 30, 2015, together with the reports thereon of our independent registered public accounting firm, are set forth on
pages F-1 to F-31 of this Amended Filing.
(2) Financial Statement Schedules.
Schedule II - Valuation and
Qualifying Accounts for the Years Ended 2015, 2014 and 2013 is incorporated by reference to page F-31 of the financial
statements included herewith. Exhibit 15(a)(2) is being furnished and shall not be deemed to be “filed” for
purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall such exhibit be
deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act or the
Exchange Act, except as otherwise stated in such filing.
(3) Exhibits.
Except as so indicated below and in Exhibit
32.1, the following exhibits are filed as part of, or incorporated by reference, the Report.
Exhibit No. |
Description |
Location |
2.1 |
Asset Purchase Agreement, dated August 24, 2005,
between PharmaCyte Biotech, Inc. (formerly Nuvilex, Inc. “Company”) and Mark
Taggatz.
|
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the
Securities and Exchange Commission (“SEC”) on August 30, 2005. |
2.2 |
Share Purchase Agreement, dated August 31, 2005, between the Company and Dr. Richard Goldfarb. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on September 7, 2005. |
2.3 |
Addendum to Share Purchase Agreement, dated August 31, 2005, between the Company and Dr. Richard Goldfarb. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on September 7, 2005. |
2.4 |
Share Exchange Agreement, dated January 12, 2009, between the Company and Freedom2 Holdings, Inc. |
Incorporated by reference from the Company’s Current Report on Form 10-K filed with the SEC on August 13, 2009. |
2.5 |
Share Exchange Agreement, dated May 26, 2011 between the Company and SG Austria Private Limited. |
Incorporated by reference from the Company’s Current Report on Form 10-Q filed with the SEC on September 14, 2011. |
2.6 |
Third Addendum, dated June 25, 2013 between the Company and SG Austria Private Limited. |
Incorporated by reference from the Company’s Report on Form 8-K filed with the SEC on July 17, 2013. |
2.7 |
Licensing Agreement, dated June 25, 2013 between the Company and Austrianova Singapore Private Limited. |
Incorporated by reference from the Company’s Report on Form 8-K filed with the SEC on July 17, 2013. |
3.1 |
Articles of Incorporation of DJH International, Inc. dated October 25, 1996. |
Incorporated by reference from the Company’s Registration Statement on Form SB-2 (File No. 333-68008) filed with the SEC on August 20, 2001. |
3.2 |
Certificate of Amendment of Articles of Incorporation of DJH International, Inc. dated October 20, 2000. |
Incorporated by reference from the Company’s Registration Statement on Form SB-2 (File No. 333-68008) filed with the SEC on August 20, 2001. |
3.3 |
Certificate of Amendment of Articles of Incorporation dated November 14, 2003. |
Incorporated by reference from the Company’s Registration Statement on Form. |
3.4 |
Certificate of Amendment of Articles of Incorporation dated June 30, 2008. |
Incorporated by reference from the Company’s Registration Statement on Form. |
3.5 |
Certificate of Amendment of Articles of Incorporation dated January 22, 2009. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on March 26, 2009. |
3.6 |
Corporate Bylaws. |
Incorporated by reference from the Company’s Registration Statement on Form SB-2 (File No. 333-68008) filed with the SEC on August 20, 2001. |
Exhibit No. |
Description |
Location |
3.7 |
Certificate of Designations, Preferences and Rights of Series E Convertible Preferred Stock dated December 20, 2007. |
Incorporated by reference from the Company’s Current Report on Form 10-K filed with the SEC on August 13, 2009. |
3.8 |
Certificate of Designations, Preferences and Rights of Series E Convertible Preferred Stock, dated April 29, 2008. |
Incorporated by reference from the Company’s Annual Report on Form 10-K filed with the SEC on August 13, 2009. |
3.9 |
Amendment No. One to the Bylaws of PharmaCyte Biotech, Inc. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on September 25, 2014. |
3.10 |
Amendment No. Two to the Bylaws of PharmaCyte Biotech, Inc. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on October 3, 2014. |
3.11 |
Articles of Merger merging PharmaCyte Biotech, Inc. with and into Nuvilex,
Inc., effective January 6, 2015. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the
SEC on January 9, 2015. |
4.1 |
Reference is made to Exhibits 3.1, 3.2 and 3.3. |
|
4.2 |
Form of Common Stock Certificate. |
Incorporated by reference from the Company’s Registration Statement on Form SB-2 (File No. 333-68008) filed with the SEC on August 20, 2001. |
4.3 |
Mutual Termination and Release Agreement dated as of May 28, 2014 between
Lincoln Park Capital Fund, LLC and the Company. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on May 29, 2014. |
10.1 |
License Agreement Relating to Encapsulated Cells Producing Viral Particles and Encapsulated Cells Expressing Biomolecules between and among Bavarian Nordic A/S, GSF – Forschungszentrum für Umwelt u. Gesundheit GmbH and Bio Blue Bird AG dated June [ ] 2005. |
Incorporated by reference from the Company’s Annual Report on Form 10-K filed with the SEC on August 4, 2014.** |
10.2 |
Amendment to License Agreement Relating to Encapsulated Cells Producing Viral Particles and Encapsulated Cells Expressing Biomolecules between and among Bavarian Nordic A/S, GSF – Forschungszentrum für Umwelt u. Gesundheit GmbH and Bio Blue Bird AG dated December 20, 2005. |
Incorporated by reference from the Company’s Annual Report on Form 10-K filed with the SEC on August 4, 2014.** |
10.3 |
Manufacturing Framework Agreement between Austrianova Singapore Pte. Ltd.
and the Company dated March 20, 2014. |
Incorporated by reference from the Company’s Annual Report on Form 10-K filed with the SEC on August 4, 2014. |
Exhibit No. |
Description |
Location |
10.4 |
Master Services Agreement between ViruSure GmbH and Registrant dated April 7, 2014. |
Incorporated by reference from the Company’s Annual Report on Form 10-K filed with the SEC on August 4, 2014. |
10.5 |
Licensing Agreement between the Company and Austrianova Singapore dated June 25, 2013. |
Incorporated by reference from the Company’s Report on Form 8-K filed with the SEC on July 18, 2013. |
10.6 |
Consulting Agreement between Vin-de-Bona Trading Company Pte. Ltd. and the
Company effective as of April 1, 2014. |
Incorporated by reference from the Company’s Annual Report on Form 10-K filed with the SEC on August 4, 2014.** |
10.7 |
Master Consultancy Agreement between BB Biotech Consulting GmbH and the
Company dated as of April 15, 2014. |
Incorporated by reference from the Company’s Annual Report on Form 10-K filed with the SEC on August 4, 2014.** |
10.8 |
Financial Advisory, Offering and At the Market Offering Engagement Letter
between Chardan Capital Markets, LLC and the Company dated May 28, 2014. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on May 29, 2014. |
10.9 † |
Memorandum of Understanding dated as of January 31, 2011 between the Company and Robert F. Ryan, M.S., Ph.D. |
Incorporated by reference from the Company’s Annual Report on Form 10-K filed with the SEC on August 4, 2014. |
10.10 † |
Employment Agreement made the 31st day of January 2012 between the Company and Robert F. Ryan, M.S., Ph.D. |
Incorporated by reference from the Company’s Annual Report on Form 10-K filed with the SEC on August 4, 2014. |
10.11 |
Collaborative Research Agreement between University of Veterinary Medicine Vienna and the Company effective as of July 1, 2014. |
Incorporated by reference from Amendment No. 1 to the Company’s Annual Report on Form 10-K/A filed with the SEC on October 16, 2014.** |
10.12 |
License Agreement between University of Technology, Sydney and PharmaCyte Australia Pty Ltd effective as of October 13, 2014. |
Incorporated by reference from Amendment No. 1 to the Company’s Annual Report on Form 10-K/A filed with the SEC on October 16, 2014.** |
10.13 |
Master Services Agreement between ViruSure GmbH and the Company effective as of August 23, 2014. |
Incorporated by reference from Amendment No. 1 to the Company’s Annual Report on Form 10-K/A filed with the SEC on October 16, 2014.** |
10.14 |
Licensing Agreement, effective December 1, 2014, between Austrianova
Singapore Pte. Ltd. and the Company. |
Incorporated by reference to the Company’s Quarterly Report on Form 10-Q filed with
the SEC on December 15, 2014. |
10.15† |
Settlement Agreement dated as of September 19, 2014, by and between PharmaCyte Biotech, Inc. and Robert F. Ryan, M.S., Ph.D. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on September 25, 2014. |
10.16† |
Asset Purchase Agreement dated as of September 19, 2014, by and between PharmaCyte Biotech, Inc. and Robert F. Ryan, M.S., Ph.D. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on September 25, 2014. |
Exhibit No. |
Description |
Location |
10.17† |
Consulting Agreement, dated September 29, 2014, between PharmaCyte Biotech, Inc. and Patricia Gruden. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on October 3, 2014. |
10.18† |
Stock Option Agreement, dated September 29, 2014, between PharmaCyte Biotech, Inc. and Patricia Gruden. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on October 3, 2014. |
10.19† |
Consulting Agreement, dated September 29, 2014, between PharmaCyte Biotech, Inc. and Timothy Matula. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on October 3, 2014. |
10.20† |
Stock Option Agreement, dated September 29, 2014, between PharmaCyte Biotech, Inc. and Timothy Matula. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on October 3, 2014. |
10.21† |
Consulting Agreement, dated September 29, 2014, between PharmaCyte Biotech, Inc. and Richard M. Goldfarb. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on October 3, 2014. |
10.22† |
Stock Option Agreement, dated September 29, 2014, between PharmaCyte Biotech, Inc. and Richard M. Goldfarb. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on October 3, 2014. |
10.23† |
Executive Compensation Agreement between the Company and Kenneth L. Waggoner
dated March 10, 2015. |
Incorporated by reference from the Company’s Quarterly Report
on Form 10-Q filed with the SEC on March 13, 2015.
|
10.24†
|
First Stock Option Agreement between the Company and Kenneth L. Waggoner
dated March 10, 2015. |
Incorporated by reference from the Company’s Quarterly Report
on Form 10-Q filed with the SEC on March 13, 2015.
|
10.25†
|
Second Stock Option Agreement between the Company
and Kenneth L. Waggoner dated March 10, 2015.
|
Incorporated by reference from the Company’s Quarterly Report on Form 10-Q filed with
the SEC on March 13, 2015. |
10.26†
|
Executive Compensation Agreement between the Company and Gerald W. Crabtree
dated March 10, 2015. |
Incorporated by reference from the Company’s Quarterly Report on Form 10-Q filed with
the SEC on March 13, 2015. |
10.27†
|
Executive Compensation Agreement between the Company and Gerald W. Crabtree
dated March 10, 2015. |
Incorporated by reference from the Company’s Quarterly Report on Form 10-Q filed with
the SEC on March 13, 2015. |
10.28†
|
Second Stock Option Agreement between the Company and Gerald W. Crabtree
dated March 10, 2015. |
Incorporated by reference from the Company’s Quarterly Report on Form 10-Q filed with
the SEC on March 13, 2015. |
10.29†
|
Letter agreement between the Company and Thomas
Liquard dated April 20, 2015.
|
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the
SEC on April 29, 2015. |
14.1 |
PharmaCyte Biotech, Inc. Code of Business Conduct and Ethics. |
Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on September 25, 2014. |
15a(2) |
Schedule II - Valuation and Qualifying Accounts for the Years Ended 2015,
2014 and 2013. |
Incorporated by reference to page F-31 of the financial statements included herewith. |
21.1 |
List of Subsidiaries. |
Incorporated by reference from the Company’s Annual Report 10-K filed with the SEC on
July 29, 2015. |
23.1 |
Consent of Farber Hass Hurley LLP |
Filed herewith. |
23.2 |
Consent of Robison, Hill & Co. |
Incorporated by reference from the Company’s Annual Report on Form 10-K filed with the
SEC on July 29, 2015. |
31.1 |
Certification of Chief Executive Officer (Principal Executive Officer
and acting Principal Financial and Principal Accounting Officer) pursuant to Rules 13a-14(a) and 15d-14(a) promulgated
under Sarbanes-Oxley Act of 1934, as amended. |
Filed herewith. |
32.1 |
Certification of Chief Executive Officer (Principal Executive Officer
and acting Principal Financial and Principal Accounting Officer) pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002*. |
Furnished herewith. |
101 |
Interactive Data Files for PharmaCyte Biotech, Inc. Form 10-K for the period ended April 30, 2015 |
Submitted herewith. |
† Indicates a management contract or any compensatory
plan, contract or arrangement.
Exhibit 15(a)(2) and Exhibit 32.1 are
being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act or otherwise
subject to the liability of that section, nor shall such exhibits be deemed to be incorporated by reference in any registration
statement or other document filed under the Securities Act or the Exchange Act, except as otherwise stated in such filing.
Financial Statements Schedule:
The following financial statement schedule
is set forth on page F-31 of this Report:
Schedule II — Valuation
and Qualifying Accounts for the years ended April 30, 2015, 2014 and 2013.
All other schedules are omitted because they
are not required, not applicable or the information is provided in the financial statements or notes thereto.
SIGNATURES
Pursuant to the requirements of Section
13 and 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
|
PHARMACYTE BIOTECH, INC. |
|
|
|
January 19 , 2016 |
|
By: /s/ Kenneth L. Waggoner
Kenneth L. Waggoner
Chief Executive Officer, Chairman of the Board and Director
(Principal Executive Officer and acting Principal Financial and Principal Accounting Officer on behalf of Registrant) |
Pursuant to the requirements
of the Exchange Act, this Report has been signed below by the following persons on behalf of the registrant and in the capacities
and on the dates indicated.
January 19, 2016 |
|
By: /s/ Kenneth L. Waggoner
Kenneth L. Waggoner
Chief Executive Officer, Chairman of the Board and Director
(Principal Executive Officer and acting Principal Financial
and Principal
Accounting Officer on behalf of Registrant) |
|
|
|
January 19 , 2016 |
|
By: /s/ Gerald W. Crabtree
Gerald W. Crabtree, PhD, Director |
|
|
|
January 19 , 2016 |
|
By: /s/ Thomas Liquard
Thomas Liquard, Director |
|
|
|
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
(AS RESTATED)
PHARMACYTE BIOTECH, INC.
(FORMERLY NUVILEX, INC.)
CONTENTS
Reports of Independent Registered Public Accounting Firms (As Restated) |
F-2 |
Consolidated Balance Sheets as of April 30, 2015 and 2014 (As Restated) |
F-4 |
Consolidated Statements of Operations for the Years Ended April 30, 2015, 2014 and 2013 (As Restated) |
F-5 |
Consolidated Statements of Comprehensive Loss for the Years Ended April 30, 2015, 2014 and 2013 (As Restated) |
F-6 |
Consolidated Statements of Stockholders’ Equity (Deficiency) for the Years Ended April 30, 2015, 2014 and 2013 (As
Restated) |
F-7 |
Consolidated Statements of Cash Flows for the Years Ended April 30, 2015, 2014 and 2013 (As Restated) |
F-8 |
Notes to Consolidated Financial Statements (As Restated) |
F-9 |
Financial Statement Schedule II - Valuation and Qualifying Accounts |
F-31 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To
the Board of Directors and
Stockholders of Pharmacyte
Biotech, Inc., formerly known as Nuvilex, Inc.
We have audited
the accompanying consolidated balance sheet of Pharmacyte Biotech, Inc., formerly known as Nuvilex, Inc. (the Company) as of April
30, 2015, and the related consolidated statements of operations, comprehensive loss, stockholders’ equity (deficiency),
and of cash flows for the year ended April 30, 2015. Our audit also included the financial statement schedule listed in the Index
at Item 15a(2). Pharmacyte Biotech, Inc.’s management is responsible for these financial statements and schedule. Our responsibility
is to express an opinion on these consolidated financial statements and schedule based on our audit.
We conducted our
audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free
of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the
consolidated financial statements. An audit also includes assessing the accounting principles used and significant estimates made
by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable
basis for our opinion.
In our opinion,
the financial statements referred to above present fairly, in all material respects, the financial position of Pharmacyte Biotech,
Inc., formerly known as Nuvilex, Inc. as of April 30, 2015, and the results of its operations and its cash flows for the year
ended April, 30, 2015, in conformity with accounting principles generally accepted in the United States of America. Also, in our
opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole,
presents fairly in all material respects the information set forth therein.
We also have audited,
in accordance with the standards of the Public Company Accounting Oversight Board (United States), Pharmacyte Biotech, Inc., formerly
known as Nuvilex, Inc.’s internal control over financial reporting as of April, 30, 2015, based on criteria established
in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway
Commission (COSO), and our report dated July 28, 2015, expressed an adverse opinion.
/s/ Farber Hass
Hurley LLP
Chatsworth, California
July 28, 2015 (Except
for Note 1A as to which the date is January [ ], 2016)
REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTANTS
To the Board of Directors and Stockholders of
Nuvilex, Inc. and Subsidiaries, now known as PharmaCyte Biotech,
Inc.
We have audited the accompanying consolidated
balance sheet of Nuvilex, Inc., now known as PharmaCyte Biotech, Inc., and Subsidiaries (“Company”) as of April 30,
2014, and the related consolidated statements of operations, comprehensive loss, stockholders’ equity (deficiency) and cash
flows for the years ended April 30, 2014 and 2013. Our audits also included the financial statement schedule listed in the Index
at Item 15a(2). These financial statements and schedule are the responsibility of the Company's management. Our responsibility
is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with
the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform
the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included
consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company’s internal control over
financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made
by management, as well as evaluating the overall presentation of the financial statements and schedule. We believe that our audits
provide a reasonable basis for our opinion.
In our opinion, the consolidated financial
statements referred to above present fairly, in all material respects, the financial position of the Company and Subsidiaries as
of April 30, 2014, and the results of its operations and its cash flows for the years ended April 30, 2014 and 2013, are in conformity
with accounting principles generally accepted in the United States of America.
Also, in our opinion, the financial statement
schedule, when considered in relation to the basic consolidated financial statements taken as a whole, present fairly, in all material
respects the information set forth herein.
/s/ Robison, Hill & Co.
Certified Public Accountants
Salt Lake City, Utah
August 1, 2014
PHARMACYTE BIOTECH,
INC.
CONSOLIDATED BALANCE
SHEETS (AS RESTATED)
| |
April 30, | |
| |
2015 | | |
2014 | |
| |
(As Restated) | | |
| |
ASSETS | |
| | |
| |
Current assets: | |
| | | |
| | |
Cash | |
$ | 2,699,737 | | |
$ | 3,616,470 | |
Prepaid expenses and other current assets | |
| 1,468,281 | | |
| 570,106 | |
Total current assets | |
| 4,168,018 | | |
| 4,186,576 | |
| |
| | | |
| | |
Other assets: | |
| | | |
| | |
Intangibles | |
| 3,549,427 | | |
| 3,549,427 | |
Investment in SG Austria | |
| 1,572,193 | | |
| 1,572,193 | |
Other assets | |
| 7,854 | | |
| 7,854 | |
Total other assets | |
| 5,129,474 | | |
| 5,129,474 | |
Total Assets | |
$ | 9,297,492 | | |
$ | 9,316,050 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 496,699 | | |
$ | 188,044 | |
Accrued expenses | |
| 23,667 | | |
| 41,763 | |
License agreement obligation | |
| 1,000,000 | | |
| – | |
Due to officer | |
| – | | |
| 143,859 | |
Total current liabilities | |
| 1,520,366 | | |
| 373,666 | |
| |
| | | |
| | |
Total Liabilities | |
| 1,520,366 | | |
| 373,666 | |
| |
| | | |
| | |
Commitments and Contingencies (Notes 11 and 12) | |
| | | |
| | |
| |
| | | |
| | |
Preferred stock, authorized 10,000,000 shares, $0.0001 par value, 0 shares issued and outstanding, respectively |
|
|
– |
|
|
|
– |
|
| |
| | | |
| | |
Stockholders' equity: | |
| | | |
| | |
Common stock, authorized 1,490,000,000 shares, $0.0001 par value,
732,760,536 and 690,615,714 shares issued and outstanding as of April 30, 2015 and 2014,
respectively |
|
|
73,273 |
|
|
|
69,063 |
|
Additional paid in capital | |
| 86,330,224 | | |
| 75,998,588 | |
Common stock to be issued | |
| – | | |
| 1,574,860 | |
Accumulated deficit | |
| (78,627,833 | ) | |
| (68,700,127 | ) |
Accumulated other comprehensive income | |
| 1,462 | | |
| – | |
Total stockholders' equity | |
| 7,777,126 | | |
| 8,942,384 | |
| |
| | | |
| | |
Total Liabilities and Stockholders' Equity | |
$ | 9,297,492 | | |
$ | 9,316,050 | |
The accompanying notes are an integral
part of these consolidated financial statements.
PHARMACYTE BIOTECH,
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS (AS RESTATED)
| |
Years Ended April 30, | |
| |
2015 | | |
2014 | | |
2013 | |
| |
(As Restated) | | |
| | |
| | |
Revenues: | |
| | | |
| | | |
| | |
Product sales | |
$ | – | | |
$ | – | | |
$ | 12,160 | |
Total revenue | |
| – | | |
| – | | |
| 12,160 | |
Cost of revenue | |
| – | | |
| – | | |
| 9,620 | |
Gross margin | |
| – | | |
| – | | |
| 2,540 | |
| |
| | | |
| | | |
| | |
Operating Expenses: | |
| | | |
| | | |
| | |
Sales and marketing | |
| 230,500 | | |
| 872,200 | | |
| 106,413 | |
Research and development costs | |
| 3,476,912 | | |
| 323,500 | | |
| – | |
Compensation expense | |
| 6,489,334 | | |
| 13,609,995 | | |
| 678,707 | |
Director fees | |
| 18,000 | | |
| 768,000 | | |
| – | |
Legal and professional | |
| 884,346 | | |
| 1,487,668 | | |
| 284,510 | |
General and administrative | |
| 2,161,643 | | |
| 1,917,779 | | |
| 617,271 | |
Total operating expenses | |
| 13,260,735 | | |
| 18,979,142 | | |
| 1,686,901 | |
| |
| | | |
| | | |
| | |
Loss from operations | |
| (13,260,735 | ) | |
| (18,979,142 | ) | |
| (1,684,361 | ) |
| |
| | | |
| | | |
| | |
Other income (expense): | |
| | | |
| | | |
| | |
Gain on forgiveness of debt | |
| – | | |
| 1,633,380 | | |
| 277,085 | |
Loss on conversion of preferred stock | |
| – | | |
| (5,895,000 | ) | |
| | |
Loss on settlement of debt | |
| – | | |
| (3,993,295 | ) | |
| (39,000 | ) |
Gain on settlements | |
| 3,337,967 | | |
| – | | |
| – | |
Other income | |
| – | | |
| – | | |
| 2,590 | |
Interest expense, net | |
| (4,938 | ) | |
| (19,963 | ) | |
| (154,416 | ) |
Total other income (expense), net | |
| 3,333,029 | | |
| (8,274,878 | ) | |
| 86,259 | |
| |
| | | |
| | | |
| | |
Net loss | |
$ | (9,927,706 | ) | |
$ | (27,254,020 | ) | |
$ | (1,598,102 | ) |
| |
| | | |
| | | |
| | |
Basic and diluted loss per share | |
$ | (0.01 | ) | |
$ | (0.05 | ) | |
$ | (0.00 | ) |
Weighted average shares outstanding basic and diluted | |
| 704,327,656 | | |
| 583,219,665 | | |
| 440,954,850 | |
The accompanying notes are an integral
part of these consolidated financial statements.
PHARMACYTE BIOTECH,
INC.
CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS (AS RESTATED)
| |
Years Ended April 30, | |
| |
2015 | | |
2014 | | |
2013 | |
| |
(As Restated) | | |
| | | |
| | |
Net Loss | |
$ | (9,927,706 | ) | |
$ | (27,254,020 | ) | |
$ | (1,598,102 | ) |
Other comprehensive income: | |
| | | |
| | | |
| | |
Foreign currency translation adjustment | |
| 1,462 | | |
| – | | |
| – | |
Other comprehensive income | |
| 1,462 | | |
| – | | |
| – | |
Comprehensive loss | |
$ | (9,926,244 | ) | |
$ | (27,254,020 | ) | |
$ | (1,598,102 | ) |
The accompanying notes are an integral
part of these consolidated financial statements.
PHARMACYTE BIOTECH,
INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIENCY) (AS RESTATED)
YEARS ENDED
APRIL 30, 2015, 2014 AND 2013
| |
Common stock | | |
Paid in | | |
Common Stock | | |
Accumulated | | |
Accumulated Other Comprehensive | | |
Total
Stockholders’ Equity | |
| |
Shares | | |
Amount | | |
Capital | | |
to be issued | | |
Deficit | | |
Income | | |
(Deficiency) | |
| |
| | | |
| | | |
(As Restated) | | |
| | | |
(As Restated) | | |
| | | |
(As Restated) | |
Balance, April 30, 2012 | |
| 416,293,195 | | |
$ | 41,631 | | |
$ | 37,526,524 | | |
$ | – | | |
$ | (39,848,005 | ) | |
$ | – | | |
| (2,279,850 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Shares issued for compensation | |
| 13,326,668 | | |
| 1,332 | | |
| 652,364 | | |
| – | | |
| – | | |
| – | | |
| 653,696 | |
Shares issued for services | |
| 8,771,429 | | |
| 877 | | |
| 330,123 | | |
| – | | |
| – | | |
| – | | |
| 331,000 | |
Shares issued for settlement of debt | |
| 3,592,656 | | |
| 359 | | |
| 143,237 | | |
| – | | |
| – | | |
| – | | |
| 143,596 | |
Shares issued for PPM | |
| 39,622,400 | | |
| 3,962 | | |
| 1,234,242 | | |
| – | | |
| – | | |
| – | | |
| 1,238,204 | |
Shares issued for cash | |
| 500,000 | | |
| 50 | | |
| 9,950 | | |
| – | | |
| – | | |
| – | | |
| 10,000 | |
Net loss | |
| – | | |
| – | | |
| – | | |
| – | | |
| (1,598,102 | ) | |
| – | | |
| (1,598,102 | ) |
Balance, April 30, 2013 | |
| 482,106,348 | | |
| 48,211 | | |
| 39,896,440 | | |
| – | | |
| (41,446,107 | ) | |
| – | | |
| (1,501,456 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Shares issued for compensation | |
| 44,370,000 | | |
| 4,437 | | |
| 13,329,351 | | |
| – | | |
| – | | |
| – | | |
| 13,333,788 | |
Shares issued for Director fees | |
| 8,000,000 | | |
| 800 | | |
| 767,200 | | |
| – | | |
| – | | |
| – | | |
| 768,000 | |
Shares issued for services | |
| 18,819,166 | | |
| 1,882 | | |
| 3,813,139 | | |
| 11,500 | | |
| – | | |
| – | | |
| 3,826,521 | |
Shares issued for settlement of debt | |
| 28,670,600 | | |
| 2,868 | | |
| 4,780,803 | | |
| – | | |
| – | | |
| – | | |
| 4,783,671 | |
Shares issued for cash | |
| 35,000,000 | | |
| 3,500 | | |
| 5,414,500 | | |
| 1,500,000 | | |
| – | | |
| – | | |
| 6,918,000 | |
Conversion of warrants | |
| 19,649,600 | | |
| 1,965 | | |
| 1,527,555 | | |
| 63,360 | | |
| – | | |
| – | | |
| 1,592,880 | |
Conversion of preferred stock | |
| 54,000,000 | | |
| 5,400 | | |
| 6,469,600 | | |
| – | | |
| – | | |
| – | | |
| 6,475,000 | |
Net loss | |
| – | | |
| – | | |
| – | | |
| – | | |
| (27,254,020 | ) | |
| – | | |
| (27,254,020 | ) |
Balance, April 30, 2014 | |
| 690,615,714 | | |
| 69,063 | | |
| 75,998,588 | | |
| 1,574,860 | | |
| (68,700,127 | ) | |
| – | | |
| 8,942,384 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Shares issued for compensation | |
| 7,200,000 | | |
| 720 | | |
| 734,468 | | |
| – | | |
| – | | |
| – | | |
| 735,188 | |
Shares issued for services | |
| 8,446,650 | | |
| 845 | | |
| 1,280,362 | | |
| (11,500 | ) | |
| – | | |
| – | | |
| 1,269,707 | |
Shares issued for cash | |
| 41,362,135 | | |
| 4,137 | | |
| 5,215,695 | | |
| (1,500,000 | ) | |
| – | | |
| – | | |
| 3,719,832 | |
Conversion of warrants | |
| 1,078,000 | | |
| 108 | | |
| 129,253 | | |
| (63,360 | ) | |
| – | | |
| – | | |
| 66,001 | |
Recovery of shares issued for compensation | |
| (15,606,667 | ) | |
| (1,566 | ) | |
| (3,336,401 | ) | |
| – | | |
| – | | |
| – | | |
| (3,337,967 | ) |
Recovery of shares issued for consulting expense | |
| (335,296 | ) | |
| (34 | ) | |
| (74,402 | ) | |
| – | | |
| – | | |
| – | | |
| (74,436 | ) |
Stock options granted | |
| – | | |
| – | | |
| 5,236,901 | | |
| – | | |
| – | | |
| – | | |
| 5,236,901 | |
Warrants granted | |
| – | | |
| – | | |
| 1,145,760 | | |
| – | | |
| – | | |
| – | | |
| 1,145,760 | |
Foreign currency translation adjustment | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 1,462 | | |
| 1,462 | |
Net loss (As Restated) | |
| – | | |
| – | | |
| – | | |
| – | | |
| (9,927,706 | ) | |
| – | | |
| (9,927,706 | ) |
Balance, April 30, 2015 | |
| 732,760,536 | | |
$ | 73,273 | | |
$ | 86,330,224 | | |
$ | – | | |
$ | (78,627,833 | ) | |
$ | 1,462 | | |
$ | 7,777,126 | |
The accompanying notes are an integral
part of these consolidated financial statements.
PHARMACYTE BIOTECH,
INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS (AS RESTATED)
| |
Years Ended April 30, | |
| |
2015 | | |
2014 | | |
2013 | |
| |
(As Restated) | | |
| | | |
| | |
Cash flows from operating activities: | |
| | | |
| | | |
| | |
Net loss | |
$ | (9,927,706 | ) | |
$ | (27,254,020 | ) | |
$ | (1,598,102 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | | |
| | |
Stock issued for services | |
| 826,023 | | |
| 17,928,309 | | |
| 984,696 | |
Stock issued for compensation | |
| 735,189 | | |
| – | | |
| – | |
Stock based compensation - options | |
| 5,236,901 | | |
| – | | |
| – | |
Stock based compensation - warrants | |
| 240,420 | | |
| – | | |
| – | |
Gain on settlements | |
| (3,337,967 | ) | |
| – | | |
| – | |
Gain on recovery of stock issued for services | |
| (74,436 | ) | |
| – | | |
| – | |
Loss on settlement of debt | |
| – | | |
| 3,993,295 | | |
| 39,000 | |
Loss on conversion of preferred stock | |
| – | | |
| 5,895,000 | | |
| – | |
Gain of forgiveness of debt | |
| – | | |
| (1,633,380 | ) | |
| (277,085 | ) |
Stock issued for interest expense | |
| – | | |
| – | | |
| 102,203 | |
Amortization of discount premium | |
| – | | |
| – | | |
| (5,695 | ) |
Change in assets and liabilities, net of effect of acquisition of business:
| |
| | | |
| | | |
| | |
Decrease in accounts receivable | |
| – | | |
| – | | |
| 2,581 | |
Decrease in inventories | |
| – | | |
| – | | |
| 6,846 | |
(Increase) / decrease in prepaid expenses and current assets | |
| 450,849 | | |
| (442,236 | ) | |
| 62,667 | |
Increase / (decrease) in accounts payable | |
| 308,654 | | |
| (59,191 | ) | |
| 97,708 | |
Increase / (decrease) in accrued expenses | |
| (18,096 | ) | |
| 17,515 | | |
| 194,755 | |
Increase in license agreement obligation | |
| 1,000,000 | | |
| – | | |
| – | |
Net cash used in operating activities | |
| (4,560,169 | ) | |
| (1,554,708 | ) | |
| (390,426 | ) |
| |
| | | |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | | |
| | |
Purchase of intangibles | |
| – | | |
| (3,500,000 | ) | |
| (646,750 | ) |
Payment towards lease deposit | |
| – | | |
| (7,854 | ) | |
| – | |
Payments towards acquisition | |
| – | | |
| (51,215 | ) | |
| – | |
Net cash used in investing activities | |
| – | | |
| (3,559,069 | ) | |
| (646,750 | ) |
| |
| | | |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | | |
| | |
Proceeds from sale of common stock | |
| 3,785,833 | | |
| 8,510,880 | | |
| 1,146,000 | |
Proceeds from borrowings, related party | |
| – | | |
| 81,586 | | |
| 149,756 | |
Repayment of debt, related party | |
| (143,859 | ) | |
| (61,522 | ) | |
| (75,000 | ) |
Net cash provided by financing activities | |
| 3,641,974 | | |
| 8,530,944 | | |
| 1,220,756 | |
| |
| | | |
| | | |
| | |
Effect of currency rate exchange on cash | |
| 1,462 | | |
| – | | |
| – | |
| |
| – | | |
| – | | |
| – | |
Net increase (decrease) in cash | |
| (916,733 | ) | |
| 3,417,167 | | |
| 183,580 | |
| |
| | | |
| | | |
| | |
Cash at beginning of the year | |
| 3,616,470 | | |
| 199,303 | | |
| 15,723 | |
Cash at end of the year | |
$ | 2,699,737 | | |
$ | 3,616,470 | | |
$ | 199,303 | |
| |
| | | |
| | | |
| | |
Supplemental disclosures of cash flows information: | |
| | | |
| | | |
| | |
Cash paid during the years for interest | |
$ | 45,141 | | |
$ | 4,117 | | |
$ | – | |
| |
| | | |
| | | |
| | |
Non cash investing and financing activities: | |
| | | |
| | | |
| | |
Common stock issued in settlement of debt | |
$ | – | | |
$ | 765,981 | | |
$ | 143,596 | |
The accompanying notes are an integral
part of these consolidated financial statements.
PHARMACYTE BIOTECH, INC.
(FORMERLY NUVILEX, INC.)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(AS RESTATED)
NOTE 1A – RESTATEMENT AND REVISION OF PREVIOUSLY REPORTED
CONSOLIDATED FINANCIAL STATEMENTS
PharmaCyte Biotech, Inc. (including, where
appropriate, its subsidiaries, “Company”) restated its consolidated financial statements as of and for the year ended
April 30, 2015 to reflect adjustments made to correct the treatment of the issuance of certain shares of the Company’s
common stock, $0.0001 par value per share (“common stock”), certain warrants and certain other matters, as further
described below, resulting in a material understatement to assets, a material overstatement to liabilities and a material understatement
to stockholders’ equity for the fourth quarter of the year ended April 30, 2015, as well as corrections to disclosures relating
to certain issuances of common stock and of options to purchase common stock to certain directors and officers of the Company.
The nature and impact of these adjustments are more particularly described below. See also Note 16, Quarterly Financial
Information (Unaudited), to the consolidated financial statements and schedule and the consolidated notes thereto (the “Restated
Financial Statements”), for the impact of these adjustments to the fourth quarter of the year ended April 30, 2015.
The adjustments described above relate
to the Company’s issuance of certain warrants to purchase common stock with a cashless exercise feature (“cashless
warrants”) in connection with its entry into a marketing and consulting agreement (“Consultant Agreement”) with
a consultant on March 23, 2015. The Company accounted for the cashless warrants as a derivative liability, as disclosed in
our Annual Report on Form 10-K for the year ended April 30, 2015, which was filed with the Securities and Exchange Commission (“Commission”)
on July 29, 2015 (the “Original Filing”). However, upon further analysis, the Company determined that the cashless
warrants should have been accounted for as equity in accordance with generally accepted accounting principles in the United States
of America (“U.S. GAAP”) in the Original Filing. Additionally, the Company determined that the Consultant Agreement,
issuance of shares of common stock to the consultant pursuant to the Consultant Agreement and the issuance of certain warrants
to purchase common stock with a cash exercise feature (“cash warrants”) and the cashless warrants should have been
recorded as a prepaid asset and amortized over the term of the Consultant Agreement in accordance with GAAP in the Original Filing.
In the Original Filing, the Company recorded a derivative liability of $492,049 on its consolidated balance sheets as of and for
the year ended April 30, 2015. As a result of the Company’s determination that the cashless warrants should be accounted
for as equity, and that the Consultant Agreement, cash warrants and cashless warrants should be accounted for as a prepaid asset,
the Company decreased general and administrative expenses by the amount of $434,754 on its consolidated statements of operations
for the year ended April 30, 2015, and increased prepaid assets by the amount of $1,349,024, net of amortization, and decreased
by the amount of $492,049 total current liabilities on its consolidated balance sheet as of April 30, 2015, as set forth in the
Restated Financial Statements. As a result of these adjustments, the Company also recorded a decrease to its accumulated
deficit in the amount of $926,803, an increase to additional paid in capital in the amount of $914,270 and an increase to total
stockholders’ equity in the amount of $1,841,073.
As set forth in this Note 1A and Note 9
to the Restated Financial Statements, the Company accounted for the expense of the cashless warrants for the year ended April 30,
2015 using the Black-Scholes option pricing model, which requires the exercise of significant judgment on the part of management
and estimates for the inputs used in the model. The following reflects the weighted-average assumptions used for purposes
of the model: risk-free interest rate of 1.41%; expected lives of the warrants of 5 years; expected volatility of 144%; no
expected dividend yield; and the number of warrants of 10,000,000.
The dividend yield assumption of zero is
based upon the fact the Company has never paid cash dividends and presently has no intention of paying cash dividends. The
risk-free interest rate used for each grant is equal to the U.S. Treasury rates in effect at the time of the grant for instruments
with a similar expected life. The expected lives are based on the remaining contractual lives of the related cashless warrants
at the valuation date. The Company’s computation of expected volatility is based on the historical daily volatility
of its publicly traded common stock.
As set forth in the Restated Financial
Statements, the effect of the timing of the recognition of the cashless warrant expense and the reclassification of the Consultant
Agreement, cash warrants and cashless warrants to prepaid assets resulted in a decrease of $926,803 to reported net loss.
In addition, as set forth in the Restated Financial Statements, the correction to the treatment of the cashless warrant expense
also resulted in an increase in consolidated other income in the net amount of $492,049 and an initial increase to consolidated
general and administrative expenses of $914,270, reduced by the reclassification of $1,349,024 to prepaid expense, for a net reduction
to consolidated general and administrative expenses in the amount of $434,754 in the Company’s consolidated statements of
operations for the year ended for the year ended April 30, 2015.
As set forth in the Restated Financial
Statements, with respect to the consolidated statement of cash flows for the year ended April 30, 2015, the adjustments described
above resulted in a decrease in net loss of $926,803, an increase in stock based compensation for warrants in the amount of $914,270,
a reduction in loss on derivative liability in the amount of $492,049 and an increase in current assets (prepaid expenses) in the
amount of $1,349,024.
Further, the Company also restated two
disclosures in Note 7, Common Stock Transactions, to the Company’s consolidated financial statements contained in
the Original Filing, as set forth in restated Note 7 to the Restated Financial Statements. The first disclosure correction
relates to the issuance of options to directors and officers to purchase 25 million shares of common stock during the year ended
April 30, 2015. The disclosure was restated to reflect that the current period non-cash compensation expense was $3,629,731
rather than the $4,307,822 as reported in the consolidated statements of operations for the year ended April 30, 2015 contained
in the Original Filing. The second disclosure correction relates to the issuance of 400,000 shares of common stock to two
officers of the Company as compensation during the year ended April 30, 2015 that was originally reported as an issuance of 600,000
shares. The disclosure was restated to reflect that the current period non-cash expense was $87,200 rather than $133,440 as reported
in the consolidated statements of operations for the year ended April 30, 2015 contained in the Original Filing and to remove the
mention of the issuance of 2,400,000 shares of common stock issued to two officers that was included in a separate disclosure.
The impact of adjustments to the Company’s
consolidated balance sheets, consolidated statements of operations, consolidated statements of comprehensive loss, consolidated
statements of stockholders’ equity (deficiency) and consolidated statements of cash flows as of and for the fiscal year ended
April 30, 2015 is as follows:
| |
April 30, 2015 | |
| |
As Previously Reported | | |
Adjustment | | |
As Restated | |
Selected Consolidated Balance Sheet Accounts | |
| | | |
| | | |
| | |
Prepaid expenses and other current assets | |
$ | 119,257 | | |
$ | 1,349,024 | | |
$ | 1,468,281 | |
Total current assets | |
$ | 2,818,994 | | |
$ | 1,349,024 | | |
$ | 4,168,018 | |
Total assets | |
$ | 7,948,468 | | |
$ | 1,349,024 | | |
$ | 9,297,492 | |
Derivative liability | |
$ | 492,049 | | |
$ | (492,049 | ) | |
$ | – | |
Total current liabilities | |
$ | 2,012,415 | | |
$ | (492,049 | ) | |
$ | 1,520,366 | |
Total liabilities | |
$ | 2,012,415 | | |
$ | (492,049 | ) | |
$ | 1,520,366 | |
Additional paid in capital | |
$ | 85,415,954 | | |
$ | 914,270 | | |
$ | 86,330,224 | |
Accumulated deficit | |
$ | (79,554,636 | ) | |
$ | 926,803 | | |
$ | (78,627,833 | ) |
Total stockholders' equity | |
$ | 5,936,053 | | |
$ | 1,841,073 | | |
$ | 7,777,126 | |
Total liabilities and stockholders' equity | |
$ | 7,948,468 | | |
$ | 1,349,024 | | |
$ | 9,297,492 | |
| |
Year Ended April 30, 2015 | |
| |
As Previously
Reported | | |
Adjustment | | |
As Restated | |
Consolidated Statement of Operation | |
| | | |
| | | |
| | |
Total revenue | |
$ | – | | |
$ | – | | |
$ | – | |
Cost of revenue | |
| – | | |
| – | | |
| – | |
Gross margin | |
| – | | |
| – | | |
| – | |
Sales and marketing expense | |
| 230,500 | | |
| – | | |
| 230,500 | |
Research and development costs | |
| 3,476,912 | | |
| – | | |
| 3,476,912 | |
Compensation expense | |
| 6,489,334 | | |
| – | | |
| 6,489,334 | |
Director fee | |
| 18,000 | | |
| – | | |
| 18,000 | |
Legal and professional | |
| 884,346 | | |
| – | | |
| 884,346 | |
General and administrative | |
| 2,596,397 | | |
| (434,754 | ) | |
| 2,161,643 | |
Loss from operations | |
| (13,695,489 | ) | |
| 434,754 | | |
| (13,260,735 | ) |
Unrealized loss on change in derivative | |
| (492,049 | ) | |
| 492,049 | | |
| – | |
Gain on settlements | |
| 3,337,967 | | |
| – | | |
| 3,337,967 | |
Interest expense, net | |
| (4,938 | ) | |
| – | | |
| (4,938 | ) |
Total other income (expense), net | |
| 2,840,980 | | |
| 492,049 | | |
| 3,333,029 | |
Net loss | |
$ | (10,854,509 | ) | |
$ | 926,803 | | |
$ | (9,927,706 | ) |
| |
| | | |
| | | |
| | |
Basic and diluted loss per share | |
$ | (0.02 | ) | |
$ | 0.01 | | |
$ | (0.01 | ) |
| |
Year Ended April 30, 2015 | |
| |
As Previously
Reported | | |
Adjustment | | |
As Restated | |
Consolidated Statement of Comprehensive Loss | |
| | | |
| | | |
| | |
Net loss | |
$ | (10,854,509 | ) | |
$ | 926,803 | | |
$ | (9,927,706 | ) |
Foreign currency translation adjustment | |
| 1,462 | | |
| – | | |
| 1,462 | |
Comprehensive loss | |
$ | (10,853,047 | ) | |
$ | 926,803 | | |
$ | (9,926,244 | ) |
| |
Year Ended April 30, 2015 | |
| |
As Previously Reported | | |
Adjustment | | |
As Restated | |
Consolidated Stockholders' Equity | |
| | | |
| | | |
| | |
Balance, April 30, 2014 | |
$ | 8,942,384 | | |
$ | | | |
$ | 8,942,384 | |
Shares issued for compensation | |
| 735,188 | | |
| | | |
| 735,188 | |
Shares issued for services | |
| 1,269,707 | | |
| | | |
| 1,269,707 | |
Shares issued for cash | |
| 3,719,832 | | |
| | | |
| 3,719,832 | |
Conversion of warrants | |
| 66,001 | | |
| | | |
| 66,001 | |
Recovery of shares issued for compensation | |
| (3,337,967 | ) | |
| | | |
| (3,337,967 | ) |
Recovery of shares issued for consulting expense | |
| (74,436 | ) | |
| | | |
| (74,436 | ) |
Stock options granted | |
| 5,236,901 | | |
| | | |
| 5,236,901 | |
Warrants granted | |
| 231,490 | | |
$ | 914,270 | | |
| 1,145,760 | |
Foreign currency translation adjustment | |
| 1,462 | | |
| | | |
| 1,462 | |
Net loss | |
| (10,854,509 | ) | |
| 926,803 | | |
| (9,927,706 | ) |
Balance, April 30, 2015 | |
$ | 5,936,053 | | |
$ | 1,841,073 | | |
$ | 7,777,126 | |
| |
Year Ended April 30, 2015 | |
| |
As Previously Reported | | |
Adjustment | | |
As Restated | |
Consolidated Statement of Cash Flows | |
| |
|
Operating activities | |
| | | |
| | | |
| | |
Net loss | |
$ | (10,854,509 | ) | |
$ | 926,803 | | |
$ | (9,927,706 | ) |
Stock issued for services | |
| 1,269,707 | | |
| (443,684 | ) | |
| 826,023 | |
Stock issued for compensation | |
| 735,189 | | |
| | | |
| 735,189 | |
Stock based compensation - options | |
| 5,236,901 | | |
| | | |
| 5,236,901 | |
Stock based compensation - warrants | |
| 231,490 | | |
| 8,930 | | |
| 240,420 | |
Gain on settlements | |
| (3,337,967 | ) | |
| | | |
| (3,337,967 | ) |
Gain on recovery of stock issued for services | |
| (74,436 | ) | |
| | | |
| (74,436 | ) |
Loss on derivative liability | |
| 492,049 | | |
| (492,049 | ) | |
| – | |
Decrease in prepaid expenses and current assets | |
| 450,849 | | |
| | | |
| 450,849 | |
Increase in accounts payable | |
| 308,654 | | |
| | | |
| 308,654 | |
Decrease in accrued expenses | |
| (18,096 | ) | |
| | | |
| (18,096 | ) |
Increase in license agreement obligation | |
| 1,000,000 | | |
| | | |
| 1,000,000 | |
Net cash used in operating activities | |
| (4,560,169 | ) | |
| – | | |
| (4,560,169 | ) |
| |
| | | |
| | | |
| | |
Investing activities | |
| | | |
| | | |
| | |
Net cash from investing activities | |
| – | | |
| – | | |
| – | |
| |
| | | |
| | | |
| | |
Financing activities | |
| | | |
| | | |
| | |
Proceeds from sale of common stock | |
| 3,785,833 | | |
| – | | |
| 3,785,833 | |
Repayment of debt, related party | |
| (143,859 | ) | |
| – | | |
| (143,859 | ) |
Net cash provided by financing activities | |
| 3,641,974 | | |
| – | | |
| 3,641,974 | |
| |
| | | |
| | | |
| | |
Effect of currency rate exchange on cash | |
| 1,462 | | |
| – | | |
| 1,462 | |
| |
| | | |
| | | |
| | |
Net decrease in cash | |
| (916,733 | ) | |
| – | | |
| (916,733 | ) |
Cash at beginning of year | |
| 3,616,470 | | |
| – | | |
| 3,616,470 | |
Cash at end of year | |
$ | 2,699,737 | | |
$ | – | | |
$ | 2,699,737 | |
NOTE 1 – NATURE OF BUSINESS
During 2013, the Company restructured
its operations in an effort to focus on biotechnology, having been primarily a nutraceutical products company in the recent past.
The restructuring resulted in the Company focusing all of its efforts upon the development of unique, effective and safe ways
to treat cancer and diabetes. On January 6, 2015, the Company changed its name from Nuvilex, Inc. to PharmaCyte Biotech, Inc.
to better reflect the nature of its business.
The Company is now a clinical stage biotechnology
company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based
live cell encapsulation technology known as “Cell-in-a-Box®”. This unique and patented technology will
be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer and its
symptoms, and diabetes are being developed.
On May 26, 2011, the Company entered into
an Asset Purchase Agreement (“SG Austria APA”) with SG Austria Private Limited (“SG Austria”) to purchase
100% of the assets and liabilities of SG Austria. As a result, Austrianova Singapore Private Limited ("Austrianova")
and Bio Blue Bird AG ("Bio Blue Bird"), wholly-owned subsidiaries of SG Austria, were to become wholly-owned subsidiaries
of the Company on the condition that the Company pay SG Austria $2.5 million and 100,000,000 shares of the Company’s common
stock and for the Company to receive 100,000 shares of Austrianova’s common stock and nine Bio Blue Bird bearer shares.
Through two addenda to the SG Austria APA,
the closing dates were extended. In June 2013, the Company and SG Austria entered into a Third Addendum to the SG Austria APA (“Third
Addendum”). Under the terms of the Third Addendum, the transaction contemplated by the SG Austria APA changed substantially.
The Third Addendum provided that the Company acquire 100% of the equity interests in Bio Blue Bird and receive a 14.5% equity interest
in SG Austria. In addition, the Company received nine bearer shares of Bio Blue Bird to evidence its 100% ownership. Under the
Third Addendum, the Company paid: (i) $500,000 to retire all outstanding debt of Bio Blue Bird; and (ii) $1.0 million to SG Austria.
The Company also paid SG Austria $1,572,193 in exchange for its 14.5% equity interest. The Third Addendum returned the original
100,000,000 shares of common stock held by SG Austria to the Company treasury, and the 100,000 Austrianova shares of common stock
held by the Company were returned to SG Austria.
The acquisition of Bio Blue Bird provided
the Company with exclusive, worldwide licenses to use a proprietary cellulose-based live cell encapsulation technology for the
development of treatments for all forms of cancer using certain types of human cells. The licenses are pursuant to patents licensed
from Bavarian Nordic A/S and GSF-Forschungszentrum fur Umwelt u. Gesundheit GmbH. These licenses enable the Company to carry out
the research and development of cancer treatments that are based upon the “Cell-in-a-Box® technology.”
In June 2013, the Company acquired from
Austrianova the exclusive, worldwide license to use the cellulose-based live cell encapsulation technology for the development
of a treatment for diabetes and the use of Austrianova’s “Cell-In-A-Box®” trademark for this technology
(“Diabetes Licensing Agreement”). The Company made its first $1,000,000 payment to secure its exclusive, worldwide
license to use the encapsulation technology for the treatment of diabetes on October 30, 2013. The second and final payment of
$1,000,000 was made on February 25, 2014, thereby fulfilling all financial obligations required to be met by the Company under
its licensing agreement with Austrianova.
In October 2014, the Company acquired from
the University of Technology Sydney (“UTS”) the exclusive license world-wide to use genetically modified cells (“Melligen
Cells”) that have been modified to produce, store and then release insulin “on demand” in developing a treatment
for insulin-dependent diabetes. In addition, the Company obtained the non-exclusive worldwide rights to “know-how”
associated with the Melligen cells. The Company intends to use the Melligen cells, after they have been encapsulated using its
Cell-in-a-Box® technology, as a treatment for insulin-dependent diabetes.
In December 2014, the Company acquired
from Austrianova the exclusive, worldwide license to use the Cell-in-a-Box® technology in combination with compounds
from constituents of Cannabis for development of disease treatments and the use of Austrianova’s “Cell-in-a-Box®”
trademark for this technology (“Cannabis Licensing Agreement”). As of April 30, 2015, the Company paid Austrianova
$1.0 million of a $2.0 million “Upfront Payment” required by the Company to be made for this license. As of the date
of this Report, the Company has paid $1.3 million of the Upfront Payment. The parties have agreed in principle to an amendment
to the license agreement pursuant to which the balance of the Upfront Payment will be due by December 31, 2015. That amendment
is in the process of being documented.
NOTE 2 – CAPITALIZATION AND MANAGEMENT PLANS (AS RESTATED)
Capitalization
The Company's consolidated financial statements
are prepared using U.S. GAAP applicable to a going concern which contemplates the realization of assets and liquidation of liabilities
in the normal course of business. As of April 30, 2015, the Company has an accumulated deficit of $78,627,833 and incurred a net
loss for year ended April 30, 2015 of $9,927,706.
Over the past year, funding was provided by
investors to maintain and expand the Company. The remaining challenges, beyond the regulatory and clinical aspects, include accessing
funding for the Company to cover its future cash flow needs. The Company continues to acquire funds through the Company’s
S-3 Registration Statement pursuant to which its exclusive placement agent, Chardan Capital Markets, LLC (“Chardan”
sells shares of common stock “at-the-market” which is structured to provide up to $50 million dollars to the Company
less certain commissions.
The Company requires substantial additional
capital to finance its planned business operations and expects to incur operating losses in future periods due to the expenses
related to the Company’s core businesses. The Company has not realized material revenue since it commenced doing business
in the biotechnology sector, and it is not without doubt that it will be successful in generating revenues in the future in this
sector. The Company believes that cash as of April 30, 2015 and the proceeds from the additional sale of registered shares will
raise sufficient capital to meet its capital requirements. From May 1, 2015 through July 13, 2015; the Company raised additional
capital of approximately $1,220,000 in “at-the-market” transactions. The Company believes that the “at-the-market”
sale of its shares will provide sufficient capital to fund its operations through July 31, 2016.
If the Company is not able to raise substantial
additional capital in a timely manner, the Company may not be able to complete its required clinical trials and may be forced to
cease operations.
The Company will continue to be dependent
on outside capital to fund its research and operating expenditures for the foreseeable future. If the Company fails to generate
positive cash flows or fails to obtain additional capital when required, the Company may need to modify, delay or abandon some
or all of its business plans.
Management Goals and Strategy
The Company’s goal is to have the
Company become an industry-leading biotechnology company using the Cell-in-a-Box® live cell encapsulation technology
as a platform upon which treatments for cancer and diabetes can be built.
The Company’s initial strategy is
to build upon and advance the success of previous Phase 1/2 and Phase 2 pancreatic cancer clinical trials. The Company’s
acquisition of Bio Blue Bird was the first step in this strategy.
The Company will seek to raise capital
to fund growth opportunities and provide for its working capital needs as its strategy is executed. The Company’s strategy
to achieve its goals consists of the following:
| · | The completion of the preparations for the Phase 2b clinical trial in advanced, inoperable pancreatic
cancer to be conducted by CNS in Australia; |
| · | The completion of the preparations for the clinical trials that will examine the effectiveness
of its pancreatic cancer treatment in ameliorating the pain and accumulation of malignant ascites fluid in the abdomen that are
characteristic of pancreatic cancer. These clinical trials will be conducted by TD2 in the United States; |
| · | The completion of preclinical studies that involve the encapsulation of a human cell line genetically
engineered to produce, store and secrete insulin on demand at levels in proportion to the levels of blood sugar in the human body.
The encapsulation will be done using the Cell-in-a-Box® technology; |
| · | The enhancement of the Company’s ability to expand into the biotechnology arena through further
research and partnering agreements; |
| · | The acquisition of new contracts that generate revenue or provide research and development capital
utilizing our sublicensing rights; |
| · | The further development of uses of the Cell-in-a-Box® technology platform through
contracts, licensing agreements and joint ventures with other companies; and |
| · | The completion of testing, expansion and marketing of existing and newly derived product candidates. |
NOTE 3 – SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES (AS RESTATED)
Principles of Consolidation and Basis of Presentation
The consolidated financial statements
include the accounts of the Company and its wholly owned subsidiaries. The Company operates independently and through four wholly-owned
subsidiaries: (i) Bio Blue Bird AG (“Bio Blue Bird”); (ii) Nuvilex Europe Limited (soon to be renamed PharmaCyte Biotech
Europe Limited); (iii) Nuvilex Australia Limited (soon to be renamed PharmaCyte Biotech Australia Private Limited); and (iv) Viridis
Biotech, Inc. (“Viridis Biotech”) and are prepared in accordance with U.S. GAAP and the rules and regulations of the
Securities and Exchange Commission (“Commission”). Intercompany balances and transactions are eliminated. The Company’s
14.5 % investment in SG Austria is presented on the cost method of accounting.
Use of Estimates
The preparation of financial statements
in accordance with U.S. GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities,
disclosure of contingent assets and liabilities known to exist as of the date the financial statements are published and the reported
amounts of revenues and expenses during the reporting period. Uncertainties with respect to such estimates and assumptions are
inherent in the preparation of the Company’s consolidated financial statements; accordingly, it is possible that the actual
results could differ from these estimates and assumptions, which could have a material effect on the reported amounts of the Company’s
consolidated financial position and results of operations.
Goodwill and Intangible Assets
The Company records the excess of purchase
price over the fair value of the identifiable net assets acquired as goodwill and other indefinite-lived intangibles. The Financial
Accounting Standards Board ("FASB") standard on goodwill and other intangible assets prescribes a two-step process for
impairment testing of goodwill and indefinite-lived intangibles, which is performed annually, as well as when an event triggering
impairment may have occurred. The first step tests for impairment, while the second step, if necessary, measures the impairment.
The Company has elected to perform its annual analysis at the end of its reporting year.
Impairment of Long-Lived Assets
The Company evaluates long-lived assets for impairment whenever
events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If the estimated future
cash flows (undiscounted and without interest charges) from the use of an asset are less than carrying value, a write-down would
be recorded to reduce the related asset to its estimated fair value. No impairment was identified or recorded during the years
ended April 30, 2015, 2014 and 2013.
Earnings per Share
Basic earnings (loss) per share are computed
by dividing earnings available to common stockholders by the weighted average number of outstanding common shares during the period.
Diluted earnings per share is computed by dividing net income by the weighted average number of shares outstanding during the period
increased to include the number of additional shares of common stock that would have been outstanding if the potentially dilutive
securities had been issued. During April 30, 2015, 2014 and 2013, the Company incurred losses; therefore the effect of any common
stock equivalent would be anti-dilutive during these periods.
Fair Value of Financial Instruments
For certain of the Company’s non-derivative
financial instruments, including cash, accounts payable and accrued expenses, the carrying amount approximates fair value due to
the short-term maturities of these instruments.
Accounting Standards Codification ("ASC")
Topic 820, “Fair Value Measurements and Disclosures,” requires disclosure of the fair value of financial instruments
held by the Company. ASC Topic 825, “Financial Instruments,” defines fair value, and establishes a three-level valuation
hierarchy for disclosures of fair value measurement that enhances disclosure requirements for fair value measures. The carrying
amounts reported in the consolidated balance sheets for receivables and current liabilities each qualify as financial instruments
and are a reasonable estimate of their fair values because of the short period of time between the origination of such instruments
and their expected realization and their current market rate of interest. The three levels of valuation hierarchy are defined as
follows:
|
· |
Level 1. Observable inputs such as quoted prices in active markets; |
|
· |
Level 2. Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and |
|
· |
Level 3. Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. |
The Company adopted ASC subtopic 820-10,
Fair Value Measurements and Disclosures ("ASC 820-10") and Accounting Standards Codification subtopic 825-10, Financial
Instruments ("ASC 825-10"), which permits entities to choose to measure many financial instruments and certain other
items at fair value. Neither of these statements had an impact on the Company's financial position, results of operations or cash
flows. The carrying value of cash, accounts payable and accrued expenses, as reflected in the balance sheets, approximate fair
value because of the short-term maturity of these instruments.
Derivative Instruments
The Company issued cashless warrants that
are accounted for as a derivative instruments which prevents them from being considered indexed to the Company’s common stock
and qualified for an exception to derivative accounting.
The Company recognized the derivative instruments
as either assets or liabilities on the accompanying consolidated balance sheets at fair value. The Company records changes in the
fair value (i.e. gains or losses) of the derivatives in the accompanying consolidated statements of operations.
Revenue Recognition
Sales of products and related costs of
products sold are recognized when: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred; (iii) the price
is fixed or determinable; and (iv) collectability is reasonably assured. These terms are typically met upon the prepayment or
invoicing and shipment of products.
Income Taxes
Deferred taxes are calculated using the
liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit
carry forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences
between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation
allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will
not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date
of enactment.
A valuation allowance is provided for deferred
income tax assets when, in management’s judgment, based upon currently available information and other factors, it is more
likely than not that all or a portion of such deferred income tax assets will not be realized. The determination of the need for
a valuation allowance is based on an on-going evaluation of current information including, among other things, historical operating
results, estimates of future earnings in different taxing jurisdictions and the expected timing of the reversals of temporary differences.
The Company believes the determination to record a valuation allowance to reduce a deferred income tax asset is a significant accounting
estimate because it is based, among other things, on an estimate of future taxable income in the United States and certain other
jurisdictions, which is susceptible to change and may or may not occur, and because the impact of adjusting a valuation allowance
may be material. In determining when to release the valuation allowance established against our net deferred income tax assets,
the Company considers all available evidence, both positive and negative. Consistent with the Company’s policy, and because
of the Company’s history of operating losses, the Company does not currently recognize the benefit of all of our deferred
tax assets, including tax loss carry forwards, that may be used to offset future taxable income. The Company continually assesses
its ability to generate sufficient taxable income during future periods in which deferred tax assets may be realized. If and when
the Company believes it is more likely than not that it will recover its deferred tax assets, the Company will reverse the valuation
allowance as an income tax benefit in the statements of operations.
The Company accounts for its uncertain
tax positions in accordance with U.S. GAAP. The purpose of this method is to clarify accounting for uncertain tax positions recognized.
The U.S. GAAP method of accounting for uncertain tax positions utilizes a two-step approach to evaluate tax positions. Step one,
recognition, requires evaluation of the tax position to determine if based solely on technical merits it is more likely than not
to be sustained upon examination. Step two, measurement, is addressed only if a position is more likely than not to be sustained.
In step two, the tax benefit is measured as the largest amount of benefit, determined on a cumulative probability basis, which
is more likely than not to be realized upon ultimate settlement with tax authorities. If a position does not meet the more likely
than not threshold for recognition in step one, no benefit is recorded until the first subsequent period in which the more likely
than not standard is met, the issue is resolved with the taxing authority or the statute of limitations expires. Positions previously
recognized are derecognized when the Company subsequently determines the position no longer is more likely than not to be sustained.
Evaluation of tax positions, their technical merits and measurements using cumulative probability are highly subjective management
estimates. Actual results could differ materially from these estimates.
Research and Development
Research and development expenses consist
of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs to acquire technologies,
including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred.
Technology developed for use in our product candidates is expensed as incurred until technological feasibility has been established.
Under the Cannabis Licensing Agreement, the
Company acquired from Austrianova an exclusive, world-wide license to use the Cell-in-a-Box® trademark and its
associated technology with genetically modified non-stem cell lines which are designed to activate cannabinoids to develop therapies
involving Cannabis.
Under the Cannabis Licensing Agreement, the
Company is required to pay Austrianova an Upfront Payment of $2,000,000. The Company has the right to make periodic monthly partial
payments of the Upfront Payment in amounts to be agreed upon between the parties prior to each such payment being made. Under
the Cannabis Licensing Agreement, the Upfront Payments must be paid in full by no later than June 30, 2015. As of April 30, 2015,
the Company has paid Austrianova $1 million of the Upfront Payment. The parties have agreed to an amendment to the Cannabis Licensing
Agreement pursuant to which the balance of the Upfront Payment will be due by December 31, 2015. That amendment is in the process
of being documented. The $2 million cost of the license has been recorded as research and development costs.
Stock-Based Compensation
The Company’s stock-based employee
compensation awards are described in Note 9. The Company has adopted the provisions of ASC 718, which requires the fair value measurement
and recognition of compensation expense for all stock-based awards made to directors, executives and employees.
Concentration of Credit Risk
The Company has no significant off-balance-sheet concentrations
of credit risk such as foreign exchange contracts, options contracts or other foreign hedging arrangements. The Company maintains
most of its cash balance at a financial institution located in California. Accounts at this institution are insured by the Federal
Deposit Insurance Corporation up to $250,000. Uninsured balances aggregated approximately $2,450,000 at April 30, 2015. The Company
has not experienced any losses in such accounts, and management believes it is not exposed to any significant credit risk on cash.
Foreign Currency Translation
The Company translates the financial statements
of its foreign subsidiary from the local (functional) currencies to US dollars in accordance with FASB ASC 830, Foreign Currency
Matters. All assets and liabilities of the Company’s foreign subsidiaries are translated at year-end exchange rates,
while revenue and expenses are translated at average exchange rates prevailing during the year. Adjustments for foreign currency
translation fluctuations are excluded from net income and are included in other comprehensive loss. Gains and losses on short-term
intercompany foreign currency transactions are recognized as incurred.
Reclassification
Certain prior year balances have been reclassified
to conform to the 2015 presentation, with no changes in net loss for prior periods presented.
Recent Accounting Pronouncements
In May 2014, the FASB issued ASU No. 2014-09
"Revenue from Contracts with Customers" (Topic 606). Topic 606 supersedes the revenue recognition requirements
in Topic 605, “Revenue Recognition”, including most industry-specific revenue recognition guidance throughout
the Industry Topics of the Codification. In addition, the amendments create a new Subtopic 340-40, “Other Assets
and Deferred Costs—Contracts with Customers”. In summary, the core principle of Topic 606 is that an entity recognizes
revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which
the entity expects to be entitled in exchange for those goods or services. For a public entity, the amendments in this Update are
effective for annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period;
early application is not permitted. The Company is currently evaluating the impact this guidance will have on its consolidated
financial position and consolidated statement of operations.
In June 2014, the FASB issued ASU No. 2014-12,
"Compensation - Stock Compensation (Topic 718)," which makes amendments to the codification topic 718, "Accounting
for Share-Based Payments," when the terms of an award provide that a performance target could be achieved after the requisite
service period. The new guidance becomes effective for annual reporting periods beginning after December 15, 2015; early adoption
is permitted. The Company is currently evaluating the impact this guidance will have on its consolidated financial position and
results of operations.
In August 2014, the Financial Accounting
Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2014-15, “Presentation of
Financial Statements – Going Concern”, Subtopic 205-40, “Disclosure of Uncertainties about an Entity’s
Ability to Continue as a Going Concern.” The amendments in this ASU apply to all entities and require management
to assess an entity’s ability to continue as a going concern by incorporating and expanding upon certain principles that
are currently in U.S. auditing standards. Specifically, the amendments: (i) provide a definition of the term substantial
doubt; (ii) require an evaluation every reporting period including interim periods; (iii) provide principles for considering
the mitigating effect of management’s plans; (iv) require certain disclosures when substantial doubt is alleviated as a
result of consideration of management’s plans; (v) require an express statement and other disclosures when substantial
doubt is not alleviated; and (vi) require an assessment for a period of one year after the date that the financial statements
are issued or available to be issued. The amendments in this Update are effective for the annual period ending after December
15, 2016. For annual periods and interim periods thereafter; early application is permitted. The Company is currently evaluating
the impact this guidance will have on its consolidated financial position and results of operations.
NOTE 4 – BUSINESS ACQUISITION
Effective as of June 25, 2013, the Company
completed the purchase of Bio Blue Bird. Shares for both Austrianova and the Company originally held in escrow under the
SG Austria APA were returned to the original owners. The 100,000,000 shares of the Company were cancelled. The acquisition
was accounted for under ASC Topic 805, “Business Combination.” Accordingly, the assets and liabilities were
fair valued and purchase accounting applied.
The assets of Bio Blue Bird are licenses
related to the Cell-in-a-Box® technology with a fair value of $1,549,427. The assets acquired were accounted for
at the fair value at the acquisition date based on current information that management believes is reasonable. After the acquisition,
Bio Blue Bird became a wholly-owned subsidiary of the Company.
Since the Company’s acquisition of
Bio Blue Bird, no revenues have been generated from the licenses; therefore, no pro-forma information has been prepared. The licenses
will be used in the development of the Company’s product candidate in advanced pancreatic cancer.
NOTE 5 – ACCRUED EXPENSES
Accrued expenses at April 30, 2015 and 2014 are summarized
below:
| |
2015 | | |
2014 | |
Accrued interest | |
$ | – | | |
$ | 33,960 | |
Deferred rent | |
| 1,480 | | |
| – | |
Payroll related costs | |
| 19,539 | | |
| – | |
Other | |
| 2,648 | | |
| 7,803 | |
Total | |
$ | 23,667 | | |
$ | 41,763 | |
NOTE 6 – DEBT
In November, 2013, the Company settled
its obligation to pay $400,000 in licensing fees, for a licensing agreement terminated in 2009 with the issuance of 2,000,000 shares
of common stock. The shares were valued at $226,000 using the closing share price of the common stock on the day of issuance resulting
in a gain on settlement of debt of $174,000.
In February, 2014, the Company settled
its obligation to pay $20,000 plus $6,000 of accrued interest to a note holder with the issuance of 250,000 shares of common stock.
The shares were valued $45,500 using the closing share price of the common stock on the day of issuance resulting in a loss on
settlement of debt of $19,500.
In December 2014, the Company entered into
a licensing agreement for a license to use the Cell-in-a-Box® technology to develop therapies involving Cannabis.
As of the date of this Report, the Company has paid $1,000,000 of a required $2,000,000 payment for the license.
NOTE 7 – COMMON STOCK TRANSACTIONS
(AS RESTATED)
The Company has amended and restated
two disclosures relating to common stock transactions. The first disclosure correction relates to the issuance of options
to directors and officers to purchase 25 million shares of common stock. The disclosure was restated to reflect that the
current period non-cash compensation expense was $3,629,731 rather than the $4,307,822 as originally reported in the
consolidated statements of operations for the year ended April 30, 2015 contained in the Original Filing. The second
disclosure correction relates to the issuance of 400,000 shares of common stock to two officers of the Company as
compensation during the year ended April 30, 2015 that was originally reported as an issuance of 600,000 shares. The
disclosure was restated to reflect that the current period non-cash expense was $87,200 rather than $133,440 as reported in
the consolidated statements of operations for the year ended April 30, 2015 contained in the Original Filing and to remove
the mention of the issuance of 2,400,000 shares of common stock issued to two officers that was included in a separate
disclosure.
During the year ended April 30, 2013, 8,771,429
shares of common stock were issued for various services. The shares were valued using the closing stock price on the day of issuance
for a total expense of $331,000.
During the year ended April 30, 2013, 3,592,656
shares of common stock were issued to settle various debts. The shares were valued using the closing stock price on the day of
issuance for a total expense of $143,596.
During the year ended April 30, 2013, 13,326,668
shares of common stock were issued to officers of the Company for compensation. The shares were valued using the closing stock
price on the day of issuance for a total expense of $653,696.
During the year ended April 30, 2013, 500,000
shares of common stock were issued for $10,000 cash.
During the year ended April 30, 2013 the
Company issued 39,622,400 shares of common stock for proceeds of $1,136,000, which were sold through the Company's Private
Placement Memorandum at approximately $0.03 per share.
In May 2013, 75,000 shares of common stock
were issued to settle debt of $32,392. The shares were valued using the closing share price of the common stock of the day of issuance,
resulting in a gain on settlement of $21,142.
During the year ended April 30, 2014, a
shareholder converted 8,500 shares of the Company’s Series E Preferred Stock (see Note 8) into 54,000,000 shares of
common stock. The shares were valued using the closing share price of the common stock on the day of issuance for a total of
$6,475,000 resulting in a loss on conversion of $5,895,000.
During the year ended April 30, 2014, 52,370,000
shares of common stock were issued to officers and directors of the Company for compensation. These shares were valued using the
closing share price of the common stock on the day of issuance for a total non-cash expense of $14,101,788.
During the year ended April 30, 2014, 13,756,666
shares of common stock were issued to consultants for services rendered to the Company. The shares were valued using the closing
share price of the common stock price on the day of issuance for a total non-cash expense of $1,810,348. As of April 30, 2014,
$528,808 of this expense had been deferred to prepaid expenses and will be expensed to future periods as determined by the term
of each agreement.
During the year ended April 30, 2014, the Company
sold 27,000,000 shares of common stock for $4,918,000. As of April 30, 2014, 17,000,000 of these shares had not yet been issued
and were disclosed as common stock to be issued.
During the year ended April 30, 2014, the Company
converted some of its Class A and Class B warrants into 19,649,600 shares of common stock for $1,592,880.
On February 14, 2014, the Company entered
into a purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Lincoln Park initially purchased 8
million shares of common stock at $0.25 per share for $2 million and had committed to invest up to an additional $25 million of
equity capital over the term of the purchase agreement. As consideration for its commitment to purchase shares of common stock
pursuant to the purchase agreement, the Company issued to Lincoln Park 5,062,500 shares of common stock upon execution of the
purchase agreement. These shares were valued at $0.169, the closing price of the stock on February 14, 2014, for non-cash expense
of $855,653. On May 28, 2014 the Company and Lincoln Park executed a Mutual Termination and Release Agreement releasing all parties
from certain obligation under the purchase agreement. As consideration for terminating the purchase agreement, the Company issued
Lincoln Park an additional 1,062,500 shares of common stock. These shares were valued at $0.28 for total non-cash expense of $297,500.
During the year ended April 30, 2015, 300,000
shares of common stock were issued to an officer of the Company for compensation. The shares were valued using the closing share
price of the common stock on the day of issuance for a total non-cash expense of $86,100.
During the year ended April 30, 2015, the Company
sold 200,000 shares of common stock for $20,000.
During the year ended April 30, 2015, the Company
converted some of its Class B warrants into 550,000 shares of common stock for $66,000.
During the year ended April 30, 2015, 17,628,000
shares of common stock were issued to fully satisfy all stock payables due in the amount of $1,574,860.
During the year ended April 30, 2015, the Company
had committed to issue 1,700,000 shares of common stock to officers as part of their employment agreements. The shares were valued
using the closing share price of the common stock on the date the accrual of the compensation for a total of a non-cash expense
of $394,250.
During the year ended April 30, 2015, the Company,
as a result of settlement agreements, accepted the return of 15,606,667 shares of its common stock from three officers. The Company
adopted subtopic ASC 845-10-30 “Treasury Stock Acquisition in Connection with a Settlement Agreement” to account
for the shares the Company received. The shares were valued at the closing price on date of their return. The Company recognized
a non-cash gain equal to the fair value of the shares in the amount of $3,337,967 and is included in other income, net in the consolidated
statements of operations.
During the year ended April 30, 2015, the Company
entered into a mutual termination agreement with a consultant. The original consulting agreement called for the issuance of 800,000
shares. The mutual termination agreement resulted in a return of 335,296 shares of the 800,000 share issued. The Company adopted
subtopic ASC 845-10-30 to account for the shares returned. The shares were valued at the closing price on the date the mutual termination
agreement was signed. The Company recognized a non-cash gain of $74,436, which is included in consulting expense in the consolidated
statements of operations.
During the year ended April 30, 2015,
the Company issued options to purchase 25 million shares to officers and directors. The options vested immediately and expire
on September 30, 2019 and are exercisable at $0.19 per share. The grant of these options resulted in a current period expense
of $3,629,731 and is included as a compensation expense in the consolidated statements of operations.
During the year ended April
30, 2015, 400,000 shares of common stock were issued to two officers of the Company for compensation. The shares were valued using
the closing share price of the common stock on the day of the issuance for a total non-cash expense of $87,200.
During the year ended April 30, 2015, the Company
issued 7,284,150 shares of common stock to consultants. The non-cash expense for these share issuances total $972,206.
During the year ended April 30, 2015, the Company
issued 3,600,000 shares of common stock to officers as part of their compensation agreements. These shares vest on quarterly basis
over a twelve-month period. The 900,000 shares that vested were valued at the date of vesting and resulted in a non-cash compensation
expense of $125,460.
During the year ended April 30, 2015, the Company
issued 1,200,000 shares of common stock to an employee as part of an employee agreement. These shares vest on quarterly basis over
a twelve-month period. The 300,000 shares that vested were valued at the date of vesting and resulted in a non-cash expense of
$41,820.
All shares were issued without registration
under the Securities Act of 1933, as amended (“Securities Act”), in reliance upon the exemption afforded by Section
4(a)(2) of the Act.
On October 24, 2014, the Company
completed a $50 million underwritten public offering. During the year ended April 30, 2015 the Company sold and issued
approximately 24.2 million shares of common stock at prices ranging from $0.10 to $0.24 per share. Net of
underwriting discounts, legal, accounting and other offering expenses, the Company received proceeds of approximately $3.7
million from the sale of these shares.
NOTE 8 – PREFERRED STOCK
The Company has one authorized series of preferred stock designated
as "Series E Preferred Stock." The Series E Preferred Stock has the following features:
|
Ÿ |
Series E Preferred Stock does not bear any dividends; |
|
Ÿ |
Each share of Series E Preferred Stock is entitled to receive its share of assets distributable upon the liquidation, dissolution or winding up of the affairs of the Company. The holders of the Series E Preferred Stock are entitled to receive cash out of the assets of the Company before any amount is paid to the holders of any capital stock of the Company of any class junior in rank to the shares of Series E Preferred Stock; |
|
Ÿ |
Each share of Series E Preferred Stock is convertible, at the holder’s option, into shares of common stock, at the average closing bid price of the common stock for five trading days prior to the conversion date; and |
|
Ÿ |
At every meeting of stockholders, every holder of shares of Series E Preferred Stock is entitled to 50,000 votes for each share of Series E Preferred Stock, with the same and identical voting rights as a holder of a share of common stock. |
During the year ended April 30, 2014, a
shareholder converted 8,500 shares of the Company’s Series E Preferred Stock (consisting of all outstanding shares of Series
E Preferred Stock) into 54,000,000 shares of common stock. These shares were valued using the closing share price of the common
stock on the day of issuance for a total of $6,475,000 resulting in a loss on conversion of $5,895,000. There are no shares of
Series E Preferred Stock currently outstanding.
Holders of Series E Preferred Stock have
specific rights to be paid in cash out of the assets of the Company prior to any junior class of common stock. As a result of the
obligations for Series E Preferred Stock, the Company has determined these redemption features have the potential to be outside
the control of the Company and, therefore, the Company has classified the Series E Preferred Stock outside of shareholders equity
in accordance with ASC 480 regarding instruments with debt and equity features. Thus, the full value for the convertible Series
E Preferred Stock was recorded outside of stockholders’ equity in the accompanying consolidated financial statements.
NOTE 9 – STOCK OPTIONS AND WARRANTS (AS RESTATED)
Stock Options
The Company granted stock options to its
directors, officers and an employee during the year ended April 30, 2015, based on compensation and director agreements.
The Company has adopted the provisions
of ASC 718, “Compensation-Stock,” which requires the measurement and recognition of compensation expense for
all stock-based awards made to employees.
The fair value of the stock options at
the date of grant was estimated using the Black-Scholes option-pricing model, based on the following assumptions:
| |
April 30, | |
| |
2015 | | |
2014 | | |
2013 | |
Risk-free interest rate | |
| 2 | % | |
| – | | |
| – | |
Expected volatility | |
| 145 | % | |
| – | | |
| – | |
Expected lives (years) | |
| 2.7 | | |
| – | | |
| – | |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % | |
| 0.00 | % |
The Company’s computation of expected
volatility is based on the historical daily volatility of its publicly traded stock. For stock option grants issued during years
ended April 30, 2015, 2014 and 2013, the Company used a calculated volatility for each grant. The Company lacks adequate information
about the exercise behavior at this time and has determined the expected term assumption under the simplified method provided for
under ASC 718, which averages the contractual term of the Company’s stock options of five years with the average vesting
term of two and one half years for an average of three years. The dividend yield assumption of zero is based upon the fact the
Company has never paid cash dividends and presently has no intention of paying cash dividends. The risk-free interest rate used
for each grant is equal to the U.S. Treasury rates in effect at the time of the grant for instruments with a similar expected life.
Based on historical experience, for the year ended April 30, 2015, the Company has estimated an annualized forfeiture rate of 5%
for stock options granted to its employees, 5% for stock options granted to officers and 5% for stock options granted to directors.
Compensation costs will be adjusted for future changes in estimated forfeitures. The Company will record additional expense if
the actual forfeitures are lower than estimated and will record a recovery of prior expense if the actual forfeiture rates are
higher than estimated. No amounts relating to employee stock-based compensation have been capitalized.
At April 30, 2015, there remained approximately
$533,000 of unrecognized compensation expense related to unvested stock options granted to current and former employees and directors,
to be recognized as expense over a weighted-average period of one year.
Presented below is the Company’s
stock option activity for employees and directors:
The weighted average fair value of stock options granted during
the years ended April 30, 2015, 2014 and 2013 are $0.10, $0.00 and $0.00, respectively.
A summary of the activity for unvested
employee stock options during the three years ended April 30, 2015 is presented below:
| |
| Options Outstanding | | |
| Weighted Average Grant Date Fair Value per Share | |
Nonvested, April 30, 2012 | |
| – | | |
$ | – | |
Granted | |
| – | | |
| | |
Vested | |
| – | | |
| | |
Forfeited | |
| – | | |
| | |
Nonvested, April 30, 2013 | |
| – | | |
| – | |
Granted | |
| – | | |
| – | |
Vested | |
| – | | |
| – | |
Forfeited | |
| – | | |
| – | |
Nonvested, April 30, 2014 | |
| – | | |
| | |
Granted | |
| 47,200,000 | | |
$ | 0.14 | |
Vested | |
| 40,600,000 | | |
| 0.15 | |
Forfeited | |
| – | | |
| – | |
Nonvested, April 30, 2015 | |
| 6,600,000 | | |
$ | 0.10 | |
The Company recorded approximately $5,237,000, $0 and $0 of
non-cash charges related to the issuance of stock options to certain directors and employees in exchange for services during the
years ended April 30, 2015, 2014 and 2013, respectively.
At April 30, 2015, there remained approximately $558,000 (subject
to change in the future based on vesting date fair value) of unrecognized compensation expense related to unvested employee stock
options to be recognized as expense over a weighted-average period of one year.
Presented below is the Company’s employee stock option
activity during the three years ended April 30, 2015:
| |
| Options Outstanding | | |
| Weighted Average Grant Date Fair Value per Share | |
Nonvested, April 30, 2012 | |
| – | | |
$ | – | |
Granted | |
| – | | |
| | |
Vested | |
| – | | |
| | |
Forfeited | |
| – | | |
| | |
Nonvested, April 30, 2013 | |
| – | | |
| – | |
Granted | |
| – | | |
| – | |
Vested | |
| – | | |
| – | |
Forfeited | |
| – | | |
| | |
Nonvested, April 30, 2014 | |
| – | | |
| | |
Granted | |
| 5,250,000 | | |
$ | 0.19 | |
Vested | |
| 5,250,000 | | |
| 0.19 | |
Forfeited | |
| – | | |
| – | |
Nonvested, April 30, 2015 | |
| – | | |
$ | – | |
The following table summarizes ranges of outstanding stock options
at April 30, 2015:
| |
Exercise Prices | |
Range of Exercise Price | |
$ | 0.19 | | |
$ | 0.11 | | |
$ | 0.18 | |
Number of Options | |
| 25,000,000 | | |
| 27,200,000 | | |
| 250,000 | |
Weighted Average Remaining Contractual Life (years) | |
| 4.42 | | |
| 4.67 | | |
| 4.98 | |
Weighted Average Stock Price | |
$ | 0.19 | | |
$ | 0.10 | | |
$ | 0.18 | |
Number of Options Exercisable | |
| 25,000,000 | | |
| 27,200,000 | | |
| 250,000 | |
Weighted Average Contractual Life (years) | |
| 5 | | |
| 5 | | |
| 5 | |
Weighted Average Exercise Price | |
$ | 0.19 | | |
$ | 0.10 | | |
$ | 0.18 | |
The aggregate intrinsic value of outstanding
options as of April 30, 2015 was approximately $1,360,000. This represents options whose exercise price was less than the closing
fair market value of the Company’s common stock on April 30, 2015 of $0.16 per share.
Warrants (As Restated)
The Company issued certain warrants to
purchase common stock with a cashless exercise feature (“cashless warrants”) in connection with its entry into a marketing
and consulting agreement (“Consultant Agreement”) with a consultant on March 23, 2015. The Company accounted
for the cashless warrants as a derivative liability, as disclosed in the Original Filing. However, upon further analysis, the Company
determined that the cashless warrants should have been accounted for as equity in accordance with U.S. GAAP in the Original Filing. Additionally,
the Company determined that the Consultant Agreement, issuance of shares of common stock to the consultant pursuant to the Consultant
Agreement and the issuance of certain warrants to purchase common stock with a cash exercise feature (“cash warrants”)
and the cashless warrants to the consultant should have been recorded as a prepaid asset and amortized over the term of the Consultant
Agreement in accordance with U.S. GAAP in the Original Filing.
The warrants issued by the Company are
classified as equity. The fair value of the warrants was recorded as additional-paid-in-capital, and no further adjustments are
made.
On January 21, 2014, the Company began
the implementation of its “Warrant Conversion Program”. The program consists of offering every holder of Class A warrants
the ability to exercise their Class A warrants, with an exercise price of $0.075 per share, into shares of common stock and an
equal number of new Class D warrants, with an exercise price of $0.25 per warrant share. As of April 30, 2015, 18,755,200
Class A warrants were converted for total cash proceeds of $1,380,720 and conversion of $25,920 of debt to an officer. The Company
has also begun to offer holders of its Class B warrants, with a conversion price of $0.12 per share, with the same terms. As of
April 30, 2015, 2,318,000 Class B warrants were exercised for total cash proceeds of $278,160. An aggregate of 18,755,200 Class
D Warrants have been issued in connection with this program.
On September 1, 2014 the Company granted
854,308 Class D Warrants to purchase common stock as part of the Warrant Conversion Program. This resulted in an expense of $100,000
under a consulting agreement to facilitate the Warrant Conversion Program. This expense is included in general and administrative
expense.
On March 23, 2015, the Company granted 5,000,000
warrants to purchase common stock at an exercise price of $0.11 per share, which expire on December 31, 2015.
On March 23, 2015, the Company granted 10,000,000
cashless warrants to acquire stock at an exercise price of $0.11 per share, which expire on March 23, 2020.
For stock warrants paid in consideration
of services rendered by non-employees, the Company recognizes consulting expense in accordance with the requirements of ASC 505-50
and ASC 505, as amended.
A summary of the Company’s warrant
activity and related information for the three years ended April 30, 2015 are shown below:
| |
| Warrants | | |
| Weighted Average Price | | |
| Weighted Average Fair Value | |
Outstanding, April 30, 2012 | |
| – | | |
$ | – | | |
$ | – | |
Issued | |
| 59,433,600 | | |
| 0.125 | | |
| 0.064 | |
Exercised | |
| – | | |
| – | | |
| – | |
Outstanding, April 30, 2013 | |
| 59,433,600 | | |
| 0.125 | | |
| 0.064 | |
Issued | |
| – | | |
| – | | |
| – | |
Exercised | |
| (1,768,000 | ) | |
| – | | |
| – | |
Outstanding, April 30, 2014 | |
| 57,665,600 | | |
| 0.18 | | |
| 0.065 | |
Issued | |
| 15,854,308 | | |
| – | | |
| – | |
Exercised | |
| (550,000 | ) | |
| – | | |
| – | |
Outstanding, April 30, 2015 | |
| 72,969,908 | | |
| – | | |
| – | |
Exercisable, April 30, 2015 | |
| 72,969,908 | | |
$ | 0.17 | | |
$ | 0.075 | |
There were no cashless exercises of
warrants on April 30, 2015 and 2014.
The following table
summarizes additional information concerning warrants outstanding and exercisable at April 30, 2015:
Range of Exercise Prices | |
Number of Warrant Shares Exercisable at 04/30/2015 | | |
Weighted Average Remaining Contractual Life | | |
Exercisable Weighted Average Exercise Price | |
$0.075, $0.11, $0.12, $0.18 and $0.25 | |
| 72,969,908 | | |
| 2.86 | | |
| 0.17 | |
| |
| | | |
| | | |
| | |
Five Year Term - $0.075 | |
| 1,056,000 | | |
| 2.45 | | |
| | |
Five Year Term - $0.12 | |
| 18,347,508 | | |
| 2.75 | | |
| | |
Five Year Term - $0.18 | |
| 19,811,200 | | |
| 2.67 | | |
| | |
Five Year Term - $0.25 | |
| 18,755,200 | | |
| 2.68 | | |
| | |
Five Year Term - $0.11 | |
| 10,000,000 | | |
| 4.90 | | |
| | |
Nine Month Term - $0.11 | |
| 5,000,000 | | |
| 0.67 | | |
| | |
| |
| 72,969,908 | | |
| | | |
| | |
NOTE 10 – LEGAL
PROCEEDINGS
The Company is not currently a party to
any pending legal proceedings, material or otherwise. There are no legal proceedings to which any property of the Company is subject.
However, in the past the Company has been the subject of litigation, claims and assessments arising out of matters occurring in
its normal business operations. In the opinion of management, none of these had a material adverse effect on the Company’s
consolidated financial position, operations and cash flows.
A summary of past litigation and claims
which have been resolved follows:
The Settlement Agreement with Cornerstone
Bank, entered into on or about May 7, 2012, concluded a prior material legal proceeding. The settlement with Cornerstone Bank was
fully satisfied with cash proceeds of $702,061 received by Cornerstone Bank through the sale of 6,374,977 of the 14,605,614 total
shares of stock collateral that was held by them. Collateral held by Cornerstone in the form of 8,230,637 shares of common stock
was returned to the Company. These shares were transferred to a third party as compensation for professional fees to be provided.
The shares were valued at the closing price of the stock on the date of the final settlement agreement for total non-cash expense
of $1,160,520. All obligations to Cornerstone have been satisfied. As a result of writing off the liability due to Cornerstone
totaling $2,341,106 and the building asset and the accumulated depreciation totaling $1,028,778, the Company recognized a gain
on settlement of debt of $1,312,328.
During the period January 1, 2012 through
March 31, 2013, Pauline M. Muggli (“Muggli”), doing business as Internet Pro Designs, and Ron Simper (“Simper”)
provided information technology consulting services (“IT Services”) to the Company. Muggli submitted invoices to the
Company for IT Services allegedly performed at the request of the Company in excess of $60,000 (“IT Invoices”). The
Company disputed the IT Services and the amount of the IT Invoices. Effective October 23, 2013, the Company, Muggli and Simper
entered into a settlement agreement pursuant to which the Company paid Muggli $3,000 in cash and issued 141,667 shares of common
stock in exchange for a release of all claim that either Muggli or Simper have against the Company. The Company provided a similar
release of all claims against Muggli and Simper. The settlement has been fully implemented. The cash consideration has been paid
and the shares of common stock have been issued to Muggli and the mutual general releases are in effect.
Freedom-2, Inc. and The General Hospital
Corporation (“General Hospital”) are parties to a Master Agreement dated October 1, 1999 and associated License Agreement
(collectively, “MGH Agreements”). Since entering into the MGH Agreements, Freedom-2 became a wholly owned subsidiary
of the Company. General Hospital claimed that Freedom-2 owed General Hospital $69,095 under the MGH Agreements (“Debt”).
The Company and Freedom-2, Inc. denied liability for the Debt, but elected to resolve the dispute without becoming involved in
time consuming and costly litigation. Effective November 1, 2013, a settlement agreement was entered into between General Hospital,
the Company and Freedom-2, Inc., pursuant to which all of the Company’s rights to five patents related to permanent, removable
tissue markings were transferred to General Hospital. In exchange, General Hospital provided a general release of all claims, including
the Debt. The Company provided General Hospital a general release of all claims. The settlement has been consummated and the mutual
general releases are in effect.
The Company’s wholly
owned subsidiary Freedom-2, Inc. and Brown University are parties to an Intellectual Property License Agreement dated May 16,
2009. Brown University asserted a claim against the Company and Freedom-2, Inc. for $400,000 under the Property License
Agreement. Although the Company and Freedom-2, Inc. denied liability, they nevertheless wanted to resolve the dispute without
becoming embroiled in time consuming and costly litigation. Effective December 9, 2013 a settlement agreement was entered
into between Brown University, the Company and Freedom-2, Inc. pursuant to which the parties released each other for all
claims relating to the Property License Agreement. In addition, the Company agreed to issue 2,000,000 shares of common stock
to Brown University to consummate the settlement. The shares were valued at $0.11 per share. The shares of common stock have
been issued and the settlement has been concluded.
NOTE 11 – RELATED PARTY TRANSACTIONS
The Company had the following related party transactions:
As of April 30, 2015, 2014 and 2013, the
Company owed Berkshire Capital $0, $0 and $393,158, respectively, for operating expenses. Berkshire Capital was, at certain times
when such amounts were outstanding, the holder of more than 5% of our outstanding shares of common stock. The highest amount outstanding
during the fiscal year ended April 30, 2013 and 2014 were $393,158 and $471,011, respectively. All loans bear interest at 6% and
were due within one to three years. During the fiscal year ended April 30, 2013, the Company did not make any payments on these
loans. During the fiscal year ended April 30, 2014, the Company repaid $471,011 of principal and $30,195 in accrued interest with
the issuance of 26 million shares of common stock. The shares were issued at prices ranging from $0.14 to $0.18.
As of April 30, 2015, 2014 and 2013,
the Company owed the Company’s former Chief Financial Officer and Chairman of the Board, Patricia Gruden, $0, $0 and
$23,200 in principal and $2,740 in interest, for a total of $25,940; respectively, for a loan she made to the Company in
2011. The loan bore interest at 8% and was due on demand. The highest amount outstanding during the fiscal year ended April
30, 2013 was $25,940. During the year ended April 30, 2014, the Company paid the outstanding principal balance of $23,200 and
accrued interest of $4,117.
As of April 30, 2013, the Company owed Dr.
Robert F. Ryan, our former Chief Scientific Officer and former Chief Executive Officer, $201,143 of principal and $20,171 of accrued
interest on a loan that is due on demand and accruing interest at 8% per year. The highest amount outstanding occurred during
the fiscal year ended April 30, 2013 and totaled $283,743. During the year ended April 30, 2013, the Company made principal payments
totaling $95,600 and no interest payments in respect of this loan. During the year ended April 30, 2014, the Company repaid $35,095
of principal in cash and converted $25,920 of principal to common stock. No payments were made towards accrued interest. As of
April 30, 2014, the balance on this loan was $140,143 of principal and $33,960 of accrued interest. During the year ended April
30, 2015, the Company repaid an additional $20,000 of principal. Effective as of September 19, 2014, Dr. Ryan resigned from the
Board and from his position as the Chief Scientific Officer of the Company. In connection with his departure, the Company entered
into the Settlement Agreement pursuant to which the Company paid Dr. Ryan $183,000, which included accrued interest of $38,685
in settlement of the full amount of his loan.
The Company owns 14.5% of the equity in SG
Austria and is reported on the cost method of accounting. The Company paid SG Austria a one-time manufacturing setup fee, as required
by the Third Addendum, in two installments in the amounts of $323,500 and $323,500 in the years ended April 30, 2015 and 2014,
respectively. In addition, SG Austria has two subsidiaries: (i) Austrianova; and (ii) Austrianova Thailand Ltd. The Company purchased
products from these subsidiaries in the approximate amount of $63,000.
Effective April 1, 2014, the Company entered
into a consulting agreement with Vin-de-Bona Trading Company Pte Ltd (“Vin-de-Bona”) pursuant to which Vin-de-Bona
agreed to provide professional consulting services to the Company. Vin-de-Bona is owned by Prof. Dr. Walter H. Günzburg and
Dr. Brian Salmons. The term of the agreement is for 12 months, automatically renewable for successive 12 month terms. After the
initial term, either party can terminate the agreement by giving the other party 30 days written notice before the effective date
of termination. The amount paid as of April 30, 2015 is approximately $97,000. In addition, the Company has issued 500,000 shares
of common stock in connection with Dr. Gunzburg’s services as the Chief Scientific Officer of the Company and 250,000 shares
to Dr. Salmons for his services on the Company’s Scientific Advisory Board.
Under the Cannabis Licensing Agreement, the
Company acquired from Austrianova an exclusive, world-wide license to use the Cell-in-a-Box® trademark and its
associated technology with genetically modified non-stem cell lines which are designed to activate cannabinoids to develop therapies
involving Cannabis.
Under the Cannabis Licensing Agreement, the
Company is required to pay Austrianova an Upfront Payment of $2,000,000. The Company has the right to make periodic monthly partial
payments of the Upfront Payment in amounts to be agreed upon between the parties prior to each such payment being made. Under
the Cannabis Licensing Agreement, the Upfront Payments must be paid in full by no later than June 30, 2015. As of April 30, 2015,
the Company has paid Austrianova $1 million of the Upfront Payment. The parties have agreed to an amendment to the Cannabis Licensing
Agreement pursuant to which the balance of the Upfront Payment will be due by December 31, 2015. That amendment is in the process
of being documented. The $2 million cost of the license has been recorded as research and development costs.
During the year ended April 30, 2015, the
Company issued stock options to directors and officers (see Note 9).
With the exception of Thomas Liquard, the
Board has determined that none of the Company’s directors satisfies the definition of Independent Director as established
in the NASDAQ Marketplace Rules. Mr. Liquard has been determined by the Board to be an Independent Director.
NOTE 12 – COMMITMENTS AND CONTINGENCIES
The Company acquires assets still in development
and enters into research and development arrangements with third parties that often require milestone and royalty payments to the
third party contingent upon the occurrence of certain future events linked to the success of the asset in development. Milestone
payments may be required, contingent upon the successful achievement of an important point in the development life-cycle of the
pharmaceutical product (e.g., approval of the product for marketing by a regulatory agency). If required by the license agreements,
the Company may have to make royalty payments based upon a percentage of the sales of the pharmaceutical products in the event
that regulatory approval for marketing is obtained.
Office Lease
The Company currently leases office space
at 12510 Prosperity Drive, Suite 310, Silver Spring, Maryland 20904. The current lease is due to expire on July 31, 2016. Rent
expense for the years ended April 30, 2015, 2014 and 2013 were $49,250, $49,085 and $56,763, respectively.
April 30, Year ending, | |
Amount | |
2016 | |
$ | 51,117 | |
2017 | |
| 12,873 | |
| |
$ | 63,990 | |
Licensing Agreements
Diabetes Licensing Agreement
The Diabetes Licensing Agreement requires the
Company to pay a fee for producing the final encapsulated cell product of $633.14 per vial of 300 capsules after production with
a minimum purchased batch size of 400 vials of any Cell-in-a-Box® product.
The Diabetes Licensing Agreement requires
the Company to make future royalty and milestone payments as follows: (i) ten percent royalty of the gross sale of all products
the Company sells; (ii) twenty percent royalty of the amount actually received by the Company from sub-licensees on sub-licensees’
gross sales; (iii) milestone payments of $100,000 within 30 days of beginning the first pre-clinical experiments using the encapsulated
cells; (iv) $500,000 within 30 days after enrollment of the first human patient in the first clinical trial; (v) $800,000 within
30 days after enrollment of the first human patient in the first Phase 3 clinical trial; and(vi) $1,000,000 due 60 days after
having a NDA or a BLA approved by the FDA or a MAA approved in Europe or its equivalent based on the country in which it is accepted
for each product.
Melligen Cell License Agreement
The Melligen Cell License Agreement does
not require any “up-front” payment to UTS. The Company is required to pay to UTS a patent administration fee amounting
to 15% on all amounts paid by UTS to prosecute and maintain patents related to the licensed property.
The Melligen Cell License Agreement requires
that the Company pay royalty payments to UTS of (i) six percent gross exploitation revenue on product sales; and (ii) twenty-five
percent of gross revenues if the product is sub-licensed by the Company. In addition, the Company is required to pay milestone
payments of: (iii) AU$ 50,000 at the successful conclusion of clinical studies; (iv) AU$ 100,000 at the successful conclusion
of Phase 1 clinical trials; (v) AU$ 450,000 at the successful conclusion of Phase 2 clinical trials; and (vi) AU$ 3,000,000 at
the conclusion of Phase 3 clinical trials.
Cannabis Licensing Agreement
Under the Cannabis Licensing Agreement, the
Company is required to pay Austrianova an Upfront Payment of $2,000,000. The Company has the right to make periodic monthly partial
payments of the Upfront Payment in amounts to be agreed upon between the parties prior to each such payment being made. Under the
Cannabis Licensing Agreement, the Upfront Payments must be paid in full by no later than June 30, 2015. As of the April 30, 2015,
the Company has paid Austrianova $1 million of the Upfront Payment. The parties have agreed to an amendment to the Cannabis Licensing
Agreement pursuant to which the balance of the Upfront Payment will be due by December 31, 2015. That amendment is in the process
of being documented.
The Cannabis Licensing Agreement requires the
Company to pay Austrianova, pursuant to a manufacturing agreement between the parties, a one-time manufacturing setup fee in the
amount of $800,000, of which 50% is required to be paid on the signing of a manufacturing agreement for a product and 50% is required
to be paid three months later. In addition, the Cannabis Licensing Agreement requires the Company to pay a fee for producing the
final encapsulated cell product of $800 per vial of 300 capsules after production with a minimum purchased batch size of 400 vials
of any Cell-in-a-Box® product.
The Cannabis Licensing Agreement requires
the Company to make future royalty and milestone payments as follows: (i) ten percent royalty of the gross sale of all products
sold by the Company; (ii) twenty percent royalty of the amount actually received by the Company from sub-licensees on sub-licensees’
gross sales value; (iii) a milestone payment of $100,000 within 30 days of beginning the first pre-clinical experiments using
the encapsulated cells; (iv) a milestone payment of $500,000 within 30 days after enrollment of the first human patient in the
first clinical trial; (v) a milestone payment of $800,000 within 30 days after enrollment of the first human patient in the first
Phase 3 clinical trial; and (vi) a milestone payment of $1,000,000 due 90 days after having a NDA or a BLA approved by the FDA
or a MAA approved in Europe or its equivalent based on the country in which it is accepted for each product.
Consulting Agreement
We have engaged ViruSure, a professional
cell growing and adventitious agent testing company that has had extensive experience with the CYP2B1-expressing cells that will
be needed for our pancreatic cancer treatment. We did so in order to recover them from frozen stocks of similar cells and regenerate
new stocks for use by us in our preclinical studies and clinical trials. ViruSure is in the process of cloning new cells from
a selected clone. Those clones will be grown to populate a MCB and WCB for our future clinical trials. There are approximately
$195,000 in future milestone payments relating to testing to be completed.
Compensation Agreements
The Company entered into executive compensation
agreements with its two executive officers and an employment agreement with one of its employees in March 2015. Each agreement
has a term of two years. The Company also entered into compensation agreements with two Board members in April 2015 which continue
in effect until the member is no longer on the Board.
NOTE 13 - INCOME TAXES (AS RESTATED)
At April 30, 2015, the Company had federal
and state net operating loss carryforwards of $33,257,000 and $33,257,000, respectively, available to offset against future taxable
income, which expire in 2019 through 2033.
Current tax laws limit the amount of loss
available to be offset against future taxable income when a substantial change in ownership occurs. Therefore, the amount available
to offset future taxable income may be limited. Based on the assessment of all available evidence including, but not limited to,
the Company’s limited operating history in its core business and lack of profitability, uncertainties of the commercial
viability of its technology, the impact of government regulations and healthcare reform initiatives and other risks normally associated
with biotechnology companies, the Company has concluded that is more likely than not that these operating loss carryforwards will
not be realized. As a result, 100% of the deferred tax valuation allowance has been recorded against these assets.
Deferred income taxes reflect the net effect
of temporary differences between the financial reporting carrying amounts of assets and liabilities and income tax carrying amounts
of assets and liabilities. The components of the Company’s deferred tax assets and liabilities, both current and long-term,
are as follows:
| |
April 30, | |
| |
2015 | | |
2014 | |
Deferred tax assets: | |
| | | |
| | |
Net operating loss carryforwards | |
$ | 13,118,046 | | |
$ | 21,328,813 | |
Forgiveness of debt | |
| – | | |
| 555,349 | |
Other | |
| 8,291 | | |
| – | |
Total deferred tax assets | |
| 13,126,337 | | |
| 21,884,162 | |
Deferred tax liabilities: | |
| | | |
| | |
Shares issued for services | |
| – | | |
| 5,701,048 | |
Conversion of preferred stock | |
| – | | |
| 2,004,300 | |
Conversion of debt | |
| – | | |
| 1,357,720 | |
Total deferred tax liabilities | |
| – | | |
| 9,063,068 | |
Net deferred tax assets | |
| 13,126,337 | | |
| 12,821,094 | |
Valuation allowance | |
| (13,126,337 | ) | |
| (12,821,094 | ) |
| |
$ | – | | |
$ | – | |
For all years presented, the Company did not
recognize any deferred tax assets or liabilities. The net change in valuation allowance for the years ended April 30, 2015 and
2014 were increases of $305,243 and $364,071, respectively.
The provision for income taxes differs from
the provision computed by applying the Federal statutory rate to net loss before income taxes as follows:
| |
Years ended April 30, | |
| |
2015 | | |
2014 | | |
2013 | |
Federal benefit at statutory rate | |
$ | (3,375,420 | ) | |
$ | (8,871,790 | ) | |
$ | (543,355 | ) |
State income taxes, net of Federal taxes | |
| (540,564 | ) | |
| (1,420,791 | ) | |
| (87,017 | ) |
Permanent differences | |
| 1,433,758 | | |
| 644,287 | | |
| 109,296 | |
Provision related to change in valuation allowance | |
| 305,243 | | |
| 364,071 | | |
| 256,694 | |
Return to provision | |
| 2,339,028 | | |
| 9,063,069 | | |
| 348,057 | |
Other, net | |
| (162,045 | ) | |
| 221,154 | | |
| (83,675 | ) |
| |
$ | – | | |
$ | – | | |
$ | – | |
There have been no changes to the Company’s
liability for unrecognized tax benefits during the year ended April 30, 2015.
The Company files income tax return in the
U.S. Federal jurisdiction and various state jurisdictions. As of the year ended April 30, 2015, the tax returns for 2009 through
2014 remain open to examination by the Internal Revenue Service and various state tax authorities.
The Company’s policy is to recognize
any interest and penalties related to unrecognized tax benefits as a component of income tax expense. As of the years ended April
30, 2015, 2014 and 2013, the Company had accrued no interest or penalties related to uncertain tax positions.
NOTE 14 – EARNINGS PER SHARE (AS RESTATED)
Basic earnings per share are based on the
weighted average number of shares outstanding for a period. Diluted earnings per share are based upon the weighted average number
of shares and potentially dilutive common shares outstanding. Potential common shares outstanding principally include stock options,
under our stock plan and warrants. During April 30, 2015, 2014 and 2013, the Company incurred losses. Accordingly, the effect of
any common stock equivalent would be anti-dilutive during those periods and are not included in the calculation of diluted weighted
average number of shares outstanding.
The table below sets forth the basic loss
per share calculations:
| |
Years Ended April 30, | |
| |
2015 | | |
2014 | | |
2013 | |
Net loss | |
$ | (9,927,706 | ) | |
$ | (27,254,020 | ) | |
$ | (1,598,102 | ) |
Basic weighted average number of shares outstanding | |
| 704,327,656 | | |
| 583,219,665 | | |
| 440,954,850 | |
Diluted weighted average number of shares outstanding | |
| 704,327,656 | | |
| 583,219,665 | | |
| 440,954,850 | |
Basic and diluted loss per share | |
$ | (0.01 | ) | |
$ | (0.05 | ) | |
$ | (0.00 | ) |
NOTE 15 – QUARTERLY FINANCIAL
INFORMATION (UNAUDITED) (AS RESTATED)
| |
| Quarter Ended 31 July | | |
| Quarter
Ended 31 Oct | | |
| Quarter Ended 31 Jan | | |
| Quarter Ended 30 April | |
2015 | |
| | | |
| | | |
| | | |
| | |
Net revenue | |
$ | – | | |
$ | – | | |
$ | – | | |
$ | – | |
Cost of revenue | |
| – | | |
| – | | |
| – | | |
| – | |
Gross profit | |
| – | | |
| – | | |
| – | | |
| – | |
Operating expenses | |
| 1,583,160 | | |
| 6,200,845 | | |
| 1,456,554 | | |
| 4,020,176 | |
Other income (expenses), net | |
| (1,664 | ) | |
| 3,336,402 | | |
| (1,496 | ) | |
| (213 | ) |
Net loss | |
$ | (1,584,824 | ) | |
$ | (2,864,443 | ) | |
$ | (1,458,050 | ) | |
$ | (4,020,389 | ) |
Net loss per common share, Basic and Diluted | |
$ | (0.00 | ) | |
$ | (0.01 | ) | |
$ | (0.00 | ) | |
$ | (0.01 | ) |
| |
| Quarter Ended 31 July | | |
| Quarter Ended 31 Oct | | |
| Quarter Ended 31 Jan | | |
| Quarter Ended 30 April | |
2014 | |
| | | |
| | | |
| | | |
| | |
Net revenue | |
$ | – | | |
$ | – | | |
$ | – | | |
$ | – | |
Cost of revenue | |
| – | | |
| – | | |
| – | | |
| – | |
Gross profit | |
| – | | |
| – | | |
| – | | |
| – | |
Operating expenses | |
| 1,400,691 | | |
| 448,570 | | |
| 681,080 | | |
| 16,448,801 | |
Other income (expenses), net | |
| (3,265,676 | ) | |
| (5,209,500 | ) | |
| 222,308 | | |
| (22.010 | ) |
Net loss | |
$ | (4,666,367 | ) | |
$ | (5,658,070 | ) | |
$ | (458,772 | ) | |
$ | (16,470,811 | ) |
Net loss per common share, Basic and Diluted | |
$ | (0.01 | ) | |
$ | (0.01 | ) | |
$ | (0.00 | ) | |
$ | (0.03 | ) |
Quarterly and year-to-date loss per share
amounts are computed independently of each other. Therefore, the sum of the per share amounts for the quarters may not agree to
the per share amounts for the year.
NOTE 16 – SUBSEQUENT EVENTS
From May 1, 2015 to July 16, 2015, the
Company issued 9,328,713 shares of common stock under the S-3 Registration Statement. The issuance of the shares provided the Company
approximately $1,220,000. The Company currently has $2,900,000 in cash as a result of the sales of common stock under the S-3 Registration
Statement.
On May 19, 2015, the Company made a payment
of $300,000 to Austrianova pursuant to the Licensing Agreement that was entered into in December 2014.
PHARMACYTE BIOTECH, INC. (FORMERLY
NUVILEX, INC.)
SCHEDULE II —
VALUATION AND QUALIFYING ACCOUNTS (AS RESTATED)
Years Ended April 30, 2015, 2014 and 2013
Description | |
| Balance at Beginning of Year | | |
| Additions
Charged to Costs and Expenses | | |
| Charged to Other Accounts | | |
| Deductions | | |
| Balance at End of Year | |
Reserve Deducted in the Balance Sheets from the Asset to Which it Applies: | |
| | | |
| | | |
| | | |
| | | |
| | |
Allowance for Deferred Tax Assets | |
| | | |
| | | |
| | | |
| | | |
| | |
Year ended April 30, 2015 | |
$ | 12,821,094 | | |
$ | – | | |
$ | 305,243 | | |
$ | – | | |
$ | 13,126,377 | |
Year ended April 30, 2014 | |
$ | 12,457,023 | | |
$ | – | | |
$ | 364,071 | | |
$ | – | | |
$ | 12,821,094 | |
Year ended April 30, 2013 | |
$ | 12,200,329 | | |
$ | – | | |
$ | 256,694 | | |
$ | – | | |
$ | 12,457,023 | |
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM
PharmaCyte Biotech, Inc.
(Formerly Nuvilex, Inc.)
Silver Spring, Maryland
We hereby consent to the incorporation
by reference in the Registration Statement on Form S-3 (No. 333-199440), as amended, of PharmaCyte Biotech, Inc., formerly Nuvilex,
Inc. (the “Company”), of our reports dated July 28, 2015, relating to the consolidated financial statements and schedule
as of April 30, 2015 and for the year then ended (as updated, with respect to Note 1A to such consolidated financial statements,
on January 19, 2016) and the effectiveness of the Company’s internal control over financial reporting as of April 30, 2015,
which appears in this Amendment No. 1 on Form 10-K/A to Annual Report on Form 10-K.
/s/ Farber Hass Hurley LLP
Chatsworth, California
January 19, 2016
EXHIBIT 31.1
CERTIFICATION
I, Kenneth L. Waggoner, certify that:
1. I have reviewed
this Amendment No. 1 to the Annual Report on Form 10-K/A of PharmaCyte Biotech, Inc. (“Report”) and its subsidiaries
for the fiscal year ended April 30, 2015;
2. Based on my knowledge, this Report
does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made,
in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
Report;
3. Based on my knowledge, the financial
statements, and other financial information included in this Report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods presented in this Report;
4. The registrant’s other certifying
officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for
the registrant and have:
(a) Designed such disclosure controls
and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this Report is being prepared;
(b) Designed such internal control over
financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles in the United States;
(c) Evaluated the effectiveness of the
registrant’s disclosure controls and procedures and presented in this Report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this Report based on such evaluation;
(d) Disclosed in this Report any change
in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal
quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably
likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying
officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s
auditors and the audit committee of the registrant’s Board of Directors (or persons performing the equivalent functions):
(a) All significant deficiencies and
material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely
affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material,
that involves management or other employees who have a significant role in the registrant’s internal control over financial
reporting.
Dated: January 19 ,
2016 |
|
By: |
/s/
Kenneth L. Waggoner |
|
|
|
Name: Kenneth L. Waggoner |
|
|
|
Title: Principal
Executive Officer and acting Principal Financial and Principal Accounting Officer on behalf of Registrant |
EXHIBIT 32.1
WRITTEN STATEMENT
PURSUANT TO
18 U.S.C. SECTION 1350
In connection with the Amendment No. 1
to the Annual Report of PharmaCyte Biotech, Inc. and its subsidiaries (“Company”) on Form 10-K/A for the year
ended April 30, 2015 as filed with the Securities and Exchange Commission on the date hereof (“Report”), the undersigned,
Kenneth L. Waggoner, Chief Executive Officer of the Company, certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of Section
13a-14(b) or 15d-14(b) of the Securities Exchange Act of 1934, as amended; and
(2) The information contained in the Report fairly presents,
in all material respects, the financial condition and results of operations of the Company.
Dated: January 19 ,
2016 |
|
By: |
/s/
Kenneth L. Waggoner |
|
|
|
Name: Kenneth L. Waggoner |
|
|
|
Title: Principal
Executive Officer and acting Principal Financial and Principal Accounting Officer on behalf of Registrant |
A signed original of this written statement required by Section
906 of the Sarbanes Oxley Act of 2002 has been provided to the Company and will be retained by the Company and will be furnished
to the SEC or its staff upon request. This exhibit is not “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934 but is instead furnished as provided by applicable rules of the SEC.
v3.3.1.900
Document and Entity Information - USD ($)
|
12 Months Ended |
|
|
Apr. 30, 2015 |
Jul. 28, 2015 |
Oct. 31, 2014 |
Document And Entity Information [Abstract] |
|
|
|
Entity Registrant Name |
PharmaCyte Biotech, Inc.
|
|
|
Entity Central Index Key |
0001157075
|
|
|
Document Type |
10-K/A
|
|
|
Document Period End Date |
Apr. 30, 2015
|
|
|
Amendment Flag |
true
|
|
|
Current Fiscal Year End Date |
--04-30
|
|
|
Entity Filer Category |
Accelerated Filer
|
|
|
Entity Common Stock, Shares Outstanding |
|
742,610,829
|
|
Document Fiscal Period Focus |
FY
|
|
|
Document Fiscal Year Focus |
2015
|
|
|
Entity Public Float |
|
|
$ 131,433,460
|
Entity Current Reporting Status |
Yes
|
|
|
Entity Well Known Seasoned Issuer |
No
|
|
|
Entity Voluntary Filers |
No
|
|
|
Amendment Description |
Restatement of financial statements.
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|
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v3.3.1.900
Consolidated Balance Sheet - USD ($)
|
Apr. 30, 2015 |
Apr. 30, 2014 |
Current Assets: |
|
|
Cash |
$ 2,699,737
|
$ 3,616,470
|
Prepaid expenses and other current assets |
1,468,281
|
570,106
|
Total Current Assets |
4,168,018
|
4,186,576
|
Other assets: |
|
|
Intangibles |
3,549,427
|
3,549,427
|
Investment in SG Austria |
1,572,193
|
1,572,193
|
Other assets |
7,854
|
7,854
|
Total other assets |
5,129,474
|
5,129,474
|
Total Assets |
9,297,492
|
9,316,050
|
Current Liabilities: |
|
|
Accounts payable |
496,699
|
188,044
|
Accrued expenses |
23,667
|
41,763
|
License agreement obligation |
1,000,000
|
0
|
Due to officer |
0
|
143,859
|
Total current liabilities |
1,520,366
|
373,666
|
Total Liabilities |
$ 1,520,366
|
$ 373,666
|
Commitments and Contingencies (Notes 11 and 12) |
|
|
Preferred stock, authorized 10,000,000 shares, $0.0001 par value, 0 shares issued and outstanding, respectively |
$ 0
|
$ 0
|
Stockholders' Equity |
|
|
Common stock, authorized 1,490,000,000 shares, $0.0001 par value, 732,760,536 and 690,615,714 shares issued and outstanding as of April 30, 2015 and 2014, respectively |
73,273
|
69,063
|
Additional paid in capital |
86,330,224
|
75,998,588
|
Common stock to be issued |
0
|
1,574,860
|
Accumulated deficit |
(78,627,833)
|
(68,700,127)
|
Accumulated other comprehensive income |
1,462
|
0
|
Total stockholders' equity |
7,777,126
|
8,942,384
|
Total Liabilities and Stockholders' Equity |
$ 9,297,492
|
$ 9,316,050
|
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v3.3.1.900
Consolidated Balance Sheet (Parenthetical) - $ / shares
|
Apr. 30, 2015 |
Apr. 30, 2014 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, authorized |
10,000,000
|
10,000,000
|
Preferred stock, issued |
0
|
0
|
Preferred stock, outstanding |
0
|
0
|
Preferred stock, par value |
$ 0.0001
|
$ .0001
|
Common stock, authorized |
1,490,000,000
|
1,490,000,000
|
Common stock issued |
732,760,536
|
690,615,714
|
Common stock, outstanding |
732,760,536
|
690,615,714
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.3.1.900
Consolidated Statements of Operations - USD ($)
|
12 Months Ended |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Revenues: |
|
|
|
Product sales |
$ 0
|
$ 0
|
$ 12,160
|
Total revenue |
0
|
0
|
12,160
|
Cost of revenues |
0
|
0
|
9,620
|
Gross margin |
0
|
0
|
2,540
|
Expenses: |
|
|
|
Sales and marketing |
230,500
|
872,200
|
106,413
|
Research and development costs |
3,476,912
|
323,500
|
0
|
Compensation expense |
6,489,334
|
13,609,995
|
678,707
|
Director fees |
18,000
|
768,000
|
0
|
Legal and professional fees |
884,346
|
1,487,668
|
284,510
|
General and administrative |
2,161,643
|
1,917,779
|
617,271
|
Total operating expenses |
13,260,735
|
18,979,142
|
1,686,901
|
Loss from operations |
(13,260,735)
|
(18,979,142)
|
(1,684,361)
|
Other income (expense): |
|
|
|
Gain on forgiveness of debt |
0
|
1,633,380
|
277,085
|
Loss on conversion of preferred stock |
0
|
(5,895,000)
|
0
|
Loss on settlement of debt |
0
|
(3,993,295)
|
(39,000)
|
Gain on settlements |
3,337,967
|
0
|
0
|
Other income |
0
|
0
|
2,590
|
Interest expense, net |
(4,938)
|
(19,963)
|
(154,416)
|
Total other income (expense), net |
3,333,029
|
(8,274,878)
|
86,259
|
Net loss |
$ (9,927,706)
|
$ (27,254,020)
|
$ (1,598,102)
|
Basic and diluted loss per share |
$ (.01)
|
$ (0.05)
|
$ 0.00
|
Weighted average shares outstanding basic and diluted |
704,327,656
|
583,219,665
|
440,954,850
|
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v3.3.1.900
Consolidated Statements of Comprehensive Loss - USD ($)
|
12 Months Ended |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Income Statement [Abstract] |
|
|
|
Net Loss |
$ (9,927,706)
|
$ (27,254,020)
|
$ (1,598,102)
|
Other comprehensive income: |
|
|
|
Foreign currency translation adjustment |
1,462
|
0
|
0
|
Other comprehensive income |
1,462
|
0
|
0
|
Comprehensive loss |
$ (9,926,244)
|
$ (27,254,020)
|
$ (1,598,102)
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v3.3.1.900
Consolidated Statement of Stockholders Equity (Deficit) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Common Stock To Be Issued [Member] |
Accumulated Deficit [Member] |
Accumulated Other Comprehensive Income [Member] |
Total |
Beginning balance, shares at Apr. 30, 2012 |
416,293,195
|
|
|
|
|
|
Beginning balance, amount at Apr. 30, 2012 |
$ 41,631
|
$ 37,526,524
|
$ 0
|
$ (39,848,005)
|
|
$ (2,279,850)
|
Shares issued for compensation, shares |
13,326,668
|
|
|
|
|
|
Shares issued for compensation, amount |
$ 1,332
|
652,364
|
|
|
|
653,696
|
Shares issued for services, shares |
8,771,429
|
|
|
|
|
|
Shares issued for services, amount |
$ 877
|
330,123
|
|
|
|
331,000
|
Shares issued for settlement of debt, shares |
3,592,656
|
|
|
|
|
|
Shares issued for settlement of debt, amount |
$ 359
|
143,237
|
|
|
|
143,596
|
Shares issued for cash, shares |
500,000
|
|
|
|
|
|
Shares issued for cash, amount |
$ 50
|
9,950
|
|
|
|
10,000
|
Shares issued for PPM, shares |
39,622,400
|
|
|
|
|
|
Shares issued for PPM, amount |
$ 3,962
|
1,234,242
|
|
|
|
1,238,204
|
Foreign currency translation adjustment |
|
|
|
|
|
0
|
Net loss |
|
|
|
(1,598,102)
|
|
(1,598,102)
|
Ending balance, shares at Apr. 30, 2013 |
482,106,348
|
|
|
|
|
|
Ending balance, amount at Apr. 30, 2013 |
$ 48,211
|
38,896,440
|
0
|
(41,446,107)
|
|
(1,501,456)
|
Shares issued for compensation, shares |
44,370,000
|
|
|
|
|
|
Shares issued for compensation, amount |
$ 4,437
|
13,329,351
|
|
0
|
|
13,333,788
|
Shares issued for Director fees, shares |
8,000,000
|
|
|
|
|
|
Shares issued for Director fees, amount |
$ 800
|
767,200
|
|
|
|
768,000
|
Shares issued for services, shares |
18,819,166
|
|
|
|
|
|
Shares issued for services, amount |
$ 1,882
|
3,813,139
|
11,500
|
|
|
3,826,521
|
Shares issued for settlement of debt, shares |
28,670,600
|
|
|
|
|
|
Shares issued for settlement of debt, amount |
$ 2,868
|
4,780,803
|
|
|
|
4,783,671
|
Shares issued for cash, shares |
35,000,000
|
|
|
|
|
|
Shares issued for cash, amount |
$ 3,500
|
5,414,500
|
1,500,000
|
|
|
6,918,000
|
Conversion of warrants, shares issued |
19,649,600
|
|
|
|
|
|
Conversion of warrants, amount |
$ 1,965
|
1,527,555
|
63,360
|
|
|
1,592,880
|
Conversion of preferred to common stock, shares |
54,000,000
|
|
|
|
|
|
Conversion of preferred to common stock, amount |
$ 5,400
|
6,469,600
|
|
|
|
6,475,000
|
Foreign currency translation adjustment |
|
|
|
|
|
0
|
Net loss |
|
|
|
(27,254,020)
|
|
(27,254,020)
|
Ending balance, shares at Apr. 30, 2014 |
690,615,714
|
|
|
|
|
|
Ending balance, amount at Apr. 30, 2014 |
$ 69,063
|
75,998,588
|
1,574,860
|
(68,700,127)
|
$ 0
|
8,942,384
|
Shares issued for compensation, shares |
7,200,000
|
|
|
|
|
|
Shares issued for compensation, amount |
$ 720
|
734,468
|
|
|
|
735,188
|
Shares issued for services, shares |
8,446,650
|
|
|
|
|
|
Shares issued for services, amount |
$ 845
|
1,280,362
|
(11,500)
|
|
|
1,269,707
|
Shares issued for cash, shares |
41,362,135
|
|
|
|
|
|
Shares issued for cash, amount |
$ 4,137
|
5,215,695
|
(1,500,000)
|
|
|
3,719,832
|
Conversion of warrants, shares issued |
1,078,000
|
|
|
|
|
|
Conversion of warrants, amount |
$ 108
|
129,253
|
(63,360)
|
|
|
66,001
|
Recovery of shares issued for compensation, shares |
(15,606,667)
|
|
|
|
|
|
Recovery of shares issued for compensation, amount |
$ (1,566)
|
(3,336,401)
|
|
|
|
(3,337,967)
|
Recovery of shares issued for consulting expense, shares |
(335,296)
|
|
|
|
|
|
Recovery of shares issued for consulting expense, amount |
$ (34)
|
(74,402)
|
|
|
|
(74,436)
|
Stock options granted |
|
5,236,901
|
|
|
|
5,236,901
|
Warrants granted |
|
1,145,760
|
|
|
|
1,145,760
|
Foreign currency translation adjustment |
|
|
|
|
1,462
|
1,462
|
Net loss |
|
|
|
(9,927,706)
|
|
(9,927,706)
|
Ending balance, shares at Apr. 30, 2015 |
732,760,536
|
|
|
|
|
|
Ending balance, amount at Apr. 30, 2015 |
$ 73,273
|
$ 86,330,224
|
$ 0
|
$ (78,627,833)
|
$ 1,462
|
$ 7,777,126
|
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v3.3.1.900
Consolidated Statements of Cash Flows - USD ($)
|
12 Months Ended |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Cash flows from operating activities: |
|
|
|
Net loss |
$ (9,927,706)
|
$ (27,254,020)
|
$ (1,598,102)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
Stock issued for services |
826,023
|
17,928,309
|
984,696
|
Stock issued for compensation |
735,189
|
0
|
0
|
Stock based compensation - options |
5,236,901
|
0
|
0
|
Stock based compensation - warrants |
240,420
|
0
|
0
|
Gain on settlements |
(3,337,967)
|
0
|
0
|
Gain on recovery of stock issued for services |
(74,436)
|
0
|
0
|
Loss on settlement of debt |
0
|
3,993,295
|
39,000
|
Loss on conversion of preferred stock |
0
|
5,895,000
|
0
|
Gain on forgiveness of debt |
0
|
(1,633,380)
|
(277,085)
|
Stock issued for interest expense |
0
|
0
|
102,203
|
Amortization of discount/premium |
0
|
0
|
(5,695)
|
Change in assets and liabilities: |
|
|
|
Decrease in accounts receivable |
0
|
0
|
2,581
|
Decrease in inventory |
0
|
0
|
6,846
|
(Increase) / decrease in prepaid expenses and current assets |
450,849
|
(442,236)
|
62,667
|
Increase / (decrease) in accounts payable |
308,654
|
(59,191)
|
97,708
|
Increase / (decrease) in accrued expenses |
(18,096)
|
17,515
|
194,755
|
Increase in license agreement obligation |
1,000,000
|
0
|
0
|
Net cash used in operating activities |
(4,560,169)
|
(1,554,708)
|
(390,426)
|
Cash flows from investing activities: |
|
|
|
Purchase of licenses |
0
|
(3,500,000)
|
(646,750)
|
Payment towards lease deposit |
0
|
(7,854)
|
0
|
Payments towards acquisition |
0
|
(51,215)
|
0
|
Net cash used by investing activities |
0
|
(3,559,069)
|
(646,750)
|
Cash flows from financing activities: |
|
|
|
Proceeds from the sale of common stock |
3,785,833
|
8,510,880
|
1,146,000
|
Proceeds from borrowings, related party |
0
|
81,586
|
149,756
|
Repayment of debt, related party |
(143,859)
|
(61,522)
|
(75,000)
|
Net cash provided by financing activities |
3,641,974
|
8,530,944
|
1,220,756
|
Effect of currency rate exchange on cash |
1,462
|
0
|
0
|
Net increase (decrease) in cash |
(916,733)
|
3,417,167
|
183,580
|
Cash at beginning of the year |
3,616,470
|
199,303
|
15,723
|
Cash at end of the year |
2,699,737
|
3,616,470
|
199,303
|
Supplementary disclosures of cash flows information: |
|
|
|
Cash paid during the year for interest |
45,141
|
4,117
|
0
|
Non-cash investing and financing activities: |
|
|
|
Common stock issued in settlement of debt |
$ 0
|
$ 765,981
|
$ 143,596
|
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v3.3.1.900
1A. RESTATEMENT AND REVISION TO PREVIOUSLY REPORTED FINANCIAL STATEMENTS
|
12 Months Ended |
Apr. 30, 2015 |
Restatement of Prior Year Income [Abstract] |
|
1A. RESTATEMENT |
PharmaCyte
Biotech, Inc. (including, where appropriate, its subsidiaries, Company) restated its consolidated financial statements
as of and for the year ended April 30, 2015 to reflect adjustments made to correct the treatment of the issuance of certain shares
of the Companys common stock, $0.0001 par value per share (common stock), certain warrants and certain other
matters, as further described below, resulting in a material understatement to assets, a material overstatement to liabilities
and a material understatement to stockholders equity for the fourth quarter of the year ended April 30, 2015, as well as
corrections to disclosures relating to certain issuances of common stock and of options to purchase common stock to certain directors
and officers of the Company. The nature and impact of these adjustments are more particularly described below. See also
Note 16, Quarterly Financial Information (Unaudited), to the consolidated financial statements and schedule and the consolidated
notes thereto (the Restated Financial Statements), for the impact of these adjustments to the fourth quarter of
the year ended April 30, 2015.
The adjustments
described above relate to the Companys issuance of certain warrants to purchase common stock with a cashless exercise feature
(cashless warrants) in connection with its entry into a marketing and consulting agreement (Consultant Agreement)
with a consultant on March 23, 2015. The Company accounted for the cashless warrants as a derivative liability, as disclosed
in our Annual Report on Form 10-K for the year ended April 30, 2015, which was filed with the Securities and Exchange Commission
(Commission) on July 29, 2015 (the Original Filing). However, upon further analysis, the Company determined
that the cashless warrants should have been accounted for as equity in accordance with generally accepted accounting principles
in the United States of America (U.S. GAAP) in the Original Filing. Additionally, the Company determined that
the Consultant Agreement, issuance of shares of common stock to the consultant pursuant to the Consultant Agreement and the issuance
of certain warrants to purchase common stock with a cash exercise feature (cash warrants) and the cashless warrants
should have been recorded as a prepaid asset and amortized over the term of the Consultant Agreement in accordance with GAAP in
the Original Filing. In the Original Filing, the Company recorded a derivative liability of $492,049 on its consolidated balance
sheets as of and for the year ended April 30, 2015. As a result of the Companys determination that the cashless warrants
should be accounted for as equity, and that the Consultant Agreement, cash warrants and cashless warrants should be accounted
for as a prepaid asset, the Company decreased general and administrative expenses by the amount of $434,754 on its consolidated
statements of operations for the year ended April 30, 2015, and increased prepaid assets by the amount of $1,349,024, net of amortization,
and decreased by the amount of $492,049 total current liabilities on its consolidated balance sheet as of April 30, 2015, as set
forth in the Restated Financial Statements. As a result of these adjustments, the Company also recorded a decrease to its
accumulated deficit in the amount of $926,803, an increase to additional paid in capital in the amount of $914,270 and an increase
to total stockholders equity in the amount of $1,841,073.
As set forth
in this Note 1A and Note 9 to the Restated Financial Statements, the Company accounted for the expense of the cashless warrants
for the year ended April 30, 2015 using the Black-Scholes option pricing model, which requires the exercise of significant judgment
on the part of management and estimates for the inputs used in the model. The following reflects the weighted-average assumptions
used for purposes of the model: risk-free interest rate of 1.41%; expected lives of the warrants of 5 years; expected volatility
of 144%; no expected dividend yield; and the number of warrants of 10,000,000.
The dividend
yield assumption of zero is based upon the fact the Company has never paid cash dividends and presently has no intention of paying
cash dividends. The risk-free interest rate used for each grant is equal to the U.S. Treasury rates in effect at the time
of the grant for instruments with a similar expected life. The expected lives are based on the remaining contractual lives
of the related cashless warrants at the valuation date. The Companys computation of expected volatility is based
on the historical daily volatility of its publicly traded common stock.
As set forth
in the Restated Financial Statements, the effect of the timing of the recognition of the cashless warrant expense and the reclassification
of the Consultant Agreement, cash warrants and cashless warrants to prepaid assets resulted in a decrease of $926,803 to reported
net loss. In addition, as set forth in the Restated Financial Statements, the correction to the treatment of the cashless
warrant expense also resulted in an increase in consolidated other income in the net amount of $492,049 and an initial increase
to consolidated general and administrative expenses of $914,270, reduced by the reclassification of $1,349,024 to prepaid expense,
for a net reduction to consolidated general and administrative expenses in the amount of $434,754 in the Companys consolidated
statements of operations for the year ended for the year ended April 30, 2015.
As set forth
in the Restated Financial Statements, with respect to the consolidated statement of cash flows for the year ended April 30, 2015,
the adjustments described above resulted in a decrease in net loss of $926,803, an increase in stock based compensation for warrants
in the amount of $914,270, a reduction in loss on derivative liability in the amount of $492,049 and an increase in current assets
(prepaid expenses) in the amount of $1,349,024.
Further,
the Company also restated two disclosures in Note 7, Common Stock Transactions, to the Companys consolidated financial
statements contained in the Original Filing, as set forth in restated Note 7 to the Restated Financial Statements. The first
disclosure correction relates to the issuance of options to directors and officers to purchase 25 million shares of common stock
during the year ended April 30, 2015. The disclosure was restated to reflect that the current period non-cash compensation
expense was $3,629,731 rather than the $4,307,822 as reported in the consolidated statements of operations for the year ended
April 30, 2015 contained in the Original Filing. The second disclosure correction relates to the issuance of 400,000 shares
of common stock to two officers of the Company as compensation during the year ended April 30, 2015 that was originally reported
as an issuance of 600,000 shares. The disclosure was restated to reflect that the current period non-cash expense was $87,200
rather than $133,440 as reported in the consolidated statements of operations for the year ended April 30, 2015 contained in the
Original Filing and to remove the mention of the issuance of 2,400,000 shares of common stock issued to two officers that was
included in a separate disclosure.
The impact
of adjustments to the Companys consolidated balance sheets, consolidated statements of operations, consolidated statements
of comprehensive loss, consolidated statements of stockholders equity (deficiency) and consolidated statements of cash
flows as of and for the fiscal year ended April 30, 2015 is as follows:
| |
April 30, 2015 | |
| |
As Previously Reported | | |
Adjustment | | |
As Restated | |
Selected Consolidated Balance Sheet Accounts | |
| | | |
| | | |
| | |
Prepaid expenses and other current
assets | |
$ | 119,257 | | |
$ | 1,349,024 | | |
$ | 1,468,281 | |
Total current assets | |
$ | 2,818,994 | | |
$ | 1,349,024 | | |
$ | 4,168,018 | |
Total assets | |
$ | 7,948,468 | | |
$ | 1,349,024 | | |
$ | 9,297,492 | |
Derivative liability | |
$ | 492,049 | | |
$ | (492,049 | ) | |
$ | | |
Total current liabilities | |
$ | 2,012,415 | | |
$ | (492,049 | ) | |
$ | 1,520,366 | |
Total liabilities | |
$ | 2,012,415 | | |
$ | (492,049 | ) | |
$ | 1,520,366 | |
Additional paid in capital | |
$ | 85,415,954 | | |
$ | 914,270 | | |
$ | 86,330,224 | |
Accumulated deficit | |
$ | (79,554,636 | ) | |
$ | 926,803 | | |
$ | (78,627,833 | ) |
Total stockholders' equity | |
$ | 5,936,053 | | |
$ | 1,841,073 | | |
$ | 7,777,126 | |
Total liabilities and stockholders' equity | |
$ | 7,948,468 | | |
$ | 1,349,024 | | |
$ | 9,297,492 | |
| |
Year Ended April
30, 2015 | |
| |
As Previously
Reported | | |
Adjustment | | |
As Restated | |
Consolidated Statement of Operation | |
| | | |
| | | |
| | |
Total revenue | |
$ | | | |
$ | | | |
$ | | |
Cost of revenue | |
| | | |
| | | |
| | |
Gross margin | |
| | | |
| | | |
| | |
Sales and marketing expense | |
| 230,500 | | |
| | | |
| 230,500 | |
Research and development costs | |
| 3,476,912 | | |
| | | |
| 3,476,912 | |
Compensation expense | |
| 6,489,334 | | |
| | | |
| 6,489,334 | |
Director fee | |
| 18,000 | | |
| | | |
| 18,000 | |
Legal and professional | |
| 884,346 | | |
| | | |
| 884,346 | |
General and administrative | |
| 2,596,397 | | |
| (434,754 | ) | |
| 2,161,643 | |
Loss from operations | |
| (13,695,489 | ) | |
| 434,754 | | |
| (13,260,735 | ) |
Unrealized loss on change
in derivative | |
| (492,049 | ) | |
| 492,049 | | |
| | |
Gain on settlements | |
| 3,337,967 | | |
| | | |
| 3,337,967 | |
Interest expense, net | |
| (4,938 | ) | |
| | | |
| (4,938 | ) |
Total other income (expense),
net | |
| 2,840,980 | | |
| 492,049 | | |
| 3,333,029 | |
Net loss | |
$ | (10,854,509 | ) | |
$ | 926,803 | | |
$ | (9,927,706 | ) |
| |
| | | |
| | | |
| | |
Basic and diluted loss
per share | |
$ | (0.02 | ) | |
$ | 0.01 | | |
$ | (0.01 | ) |
| |
Year Ended April
30, 2015 | |
| |
As Previously
Reported | | |
Adjustment | | |
As Restated | |
Consolidated Statement of Comprehensive Loss | |
| | | |
| | | |
| | |
Net loss | |
$ | (10,854,509 | ) | |
$ | 926,803 | | |
$ | (9,927,706 | ) |
Foreign currency translation
adjustment | |
| 1,462 | | |
| | | |
| 1,462 | |
Comprehensive loss | |
$ | (10,853,047 | ) | |
$ | 926,803 | | |
$ | (9,926,244 | ) |
| |
Year Ended April
30, 2015 | |
| |
As Previously Reported | | |
Adjustment | | |
As Restated | |
Consolidated Stockholders' Equity | |
| | | |
| | | |
| | |
Balance, April 30, 2014 | |
$ | 8,942,384 | | |
$ | | | |
$ | 8,942,384 | |
Shares issued for compensation | |
| 735,188 | | |
| | | |
| 735,188 | |
Shares issued for services | |
| 1,269,707 | | |
| | | |
| 1,269,707 | |
Shares issued for cash | |
| 3,719,832 | | |
| | | |
| 3,719,832 | |
Conversion of warrants | |
| 66,001 | | |
| | | |
| 66,001 | |
Recovery of shares issued for compensation | |
| (3,337,967 | ) | |
| | | |
| (3,337,967 | ) |
Recovery of shares issued for consulting expense | |
| (74,436 | ) | |
| | | |
| (74,436 | ) |
Stock options granted | |
| 5,236,901 | | |
| | | |
| 5,236,901 | |
Warrants granted | |
| 231,490 | | |
| 914,270 | | |
| 1,145,760 | |
Foreign currency translation adjustment | |
| 1,462 | | |
| | | |
| 1,462 | |
Net loss | |
| (10,854,509 | ) | |
| 926,803 | | |
| (11,276,730 | ) |
Balance, April 30, 2015 | |
$ | 5,936,053 | | |
$ | 1,841,073 | | |
$ | 7,777,126 | |
| |
Year Ended April
30, 2015 | |
| |
As Previously Reported | | |
Adjustment | | |
As Restated | |
Consolidated Statement of Cash Flows | |
| |
|
Operating activities | |
| | | |
| | | |
| | |
Net loss | |
$ | (10,854,509 | ) | |
$ | 926,803 | | |
$ | (9,927,706 | ) |
Stock issued for services | |
| 1,269,707 | | |
| (443,684 | ) | |
| 826,023 | |
Stock issued for compensation | |
| 735,189 | | |
| | | |
| 735,189 | |
Stock based compensation - options | |
| 5,236,901 | | |
| | | |
| 5,236,901 | |
Stock based compensation - warrants | |
| 231,490 | | |
| 8,930 | | |
| 240,420 | |
Gain on settlements | |
| (3,337,967 | ) | |
| | | |
| (3,337,967 | ) |
Gain on recovery of stock issued for services | |
| (74,436 | ) | |
| | | |
| (74,436 | ) |
Loss on derivative liability | |
| 492,049 | | |
| (492,049 | ) | |
| | |
Decrease in prepaid expenses and current assets | |
| 450,849 | | |
| | | |
| 450,849 | |
Increase in accounts payable | |
| 308,654 | | |
| | | |
| 308,654 | |
Decrease in accrued expenses | |
| (18,096 | ) | |
| | | |
| (18,096 | ) |
Increase in license agreement
obligation | |
| 1,000,000 | | |
| | | |
| 1,000,000 | |
Net cash used in operating
activities | |
| (4,560,169 | ) | |
| | | |
| (4,560,169 | ) |
| |
| | | |
| | | |
| | |
Investing activities | |
| | | |
| | | |
| | |
Net cash from investing
activities | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | |
Financing activities | |
| | | |
| | | |
| | |
Proceeds from sale of common stock | |
| 3,785,833 | | |
| | | |
| 3,785,833 | |
Repayment of debt, related
party | |
| (143,859 | ) | |
| | | |
| (143,859 | ) |
Net cash provided by financing
activities | |
| 3,641,974 | | |
| | | |
| 3,641,974 | |
| |
| | | |
| | | |
| | |
Effect of currency rate exchange on cash | |
| 1,462 | | |
| | | |
| 1,462 | |
| |
| | | |
| | | |
| | |
Net decrease in cash | |
| (916,733 | ) | |
| | | |
| (916,733 | ) |
Cash at beginning of year | |
| 3,616,470 | | |
| | | |
| 3,616,470 | |
Cash at end of year | |
$ | 2,699,737 | | |
$ | | | |
$ | 2,699,737 | |
|
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v3.3.1.900
1. NATURE OF BUSINESS
|
12 Months Ended |
Apr. 30, 2015 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
NATURE OF BUSINESS |
During
2013, the Company restructured its operations in an effort to focus on biotechnology, having been primarily a
nutraceutical products company in the recent past. The restructuring resulted in the Company focusing all of its efforts upon
the development of unique, effective and safe ways to treat cancer and diabetes. On January 6, 2015, the Company changed its
name from Nuvilex, Inc. to PharmaCyte Biotech, Inc. to better reflect the nature of its business.
The Company
is now a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes
based upon a proprietary cellulose-based live cell encapsulation technology known as Cell-in-a-Box®.
This unique and patented technology will be used as a platform upon which treatments for several types of cancer, including advanced,
inoperable pancreatic cancer and its symptoms, and diabetes are being developed.
On May 26,
2011, the Company entered into an Asset Purchase Agreement (SG Austria APA) with SG Austria Private Limited (SG
Austria) to purchase 100% of the assets and liabilities of SG Austria. As a result, Austrianova Singapore Private Limited
("Austrianova") and Bio Blue Bird AG ("Bio Blue Bird"), wholly-owned subsidiaries of SG Austria, were to become
wholly-owned subsidiaries of the Company on the condition that the Company pay SG Austria $2.5 million and 100,000,000 shares
of the Companys common stock and for the Company to receive 100,000 shares of Austrianovas common stock and nine
Bio Blue Bird bearer shares.
Through two
addenda to the SG Austria APA, the closing dates were extended. In June 2013, the Company and SG Austria entered into a Third
Addendum to the SG Austria APA (Third Addendum). Under the terms of the Third Addendum, the transaction contemplated
by the SG Austria APA changed substantially. The Third Addendum provided that the Company acquire 100% of the equity interests
in Bio Blue Bird and receive a 14.5% equity interest in SG Austria. In addition, the Company received nine bearer shares of Bio
Blue Bird to evidence its 100% ownership. Under the Third Addendum, the Company paid: (i) $500,000 to retire all outstanding debt
of Bio Blue Bird; and (ii) $1.0 million to SG Austria. The Company also paid SG Austria $1,572,193 in exchange for its 14.5% equity
interest. The Third Addendum returned the original 100,000,000 shares of common stock held by SG Austria to the Company treasury,
and the 100,000 Austrianova shares of common stock held by the Company were returned to SG Austria.
The acquisition
of Bio Blue Bird provided the Company with exclusive, worldwide licenses to use a proprietary cellulose-based live cell encapsulation
technology for the development of treatments for all forms of cancer using certain types of human cells. The licenses are pursuant
to patents licensed from Bavarian Nordic A/S and GSF-Forschungszentrum fur Umwelt u. Gesundheit GmbH. These licenses enable the
Company to carry out the research and development of cancer treatments that are based upon the Cell-in-a-Box®
technology.
In June 2013,
the Company acquired from Austrianova the exclusive, worldwide license to use the cellulose-based live cell encapsulation technology
for the development of a treatment for diabetes and the use of Austrianovas Cell-In-A-Box®
trademark for this technology (Diabetes Licensing Agreement). The Company made its first $1,000,000 payment to secure
its exclusive, worldwide license to use the encapsulation technology for the treatment of diabetes on October 30, 2013. The second
and final payment of $1,000,000 was made on February 25, 2014, thereby fulfilling all financial obligations required to be met
by the Company under its licensing agreement with Austrianova.
In October
2014, the Company acquired from the University of Technology Sydney (UTS) the exclusive license world-wide to use
genetically modified cells (Melligen Cells) that have been modified to produce, store and then release insulin on
demand in developing a treatment for insulin-dependent diabetes. In addition, the Company obtained the non-exclusive worldwide
rights to know-how associated with the Melligen cells. The Company intends to use the Melligen cells, after they
have been encapsulated using its Cell-in-a-Box® technology, as a treatment for insulin-dependent diabetes.
In December
2014, the Company acquired from Austrianova the exclusive, worldwide license to use the Cell-in-a-Box® technology
in combination with compounds from constituents of Cannabis for development of disease treatments and the use of Austrianovas
Cell-in-a-Box® trademark for this technology (Cannabis Licensing Agreement). As of
April 30, 2015, the Company paid Austrianova $1.0 million of a $2.0 million Upfront Payment required by the Company
to be made for this license. As of the date of this Report, the Company has paid $1.3 million of the Upfront Payment. The parties
have agreed in principle to an amendment to the license agreement pursuant to which the balance of the Upfront Payment will be
due by December 31, 2015. That amendment is in the process of being documented.
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v3.3.1.900
2. CAPITALIZATION AND MANAGEMENT PLANS
|
12 Months Ended |
Apr. 30, 2015 |
Capitalization And Management Plans |
|
CAPITALIZATION AND MANAGEMENT PLANS |
Capitalization
The Company's
consolidated financial statements are prepared using generally accepted accounting principles in the United States of America
(U.S. GAAP) applicable to a going concern which contemplates the realization of assets and liquidation of liabilities
in the normal course of business. As of April 30, 2015, the Company has an accumulated deficit of $78,627,833 and incurred a net
loss for year ended April 30, 2015 of $9,927,706.
Over the past
year, funding was provided by investors to maintain and expand the Company. The remaining challenges, beyond the regulatory and
clinical aspects, include accessing funding for the Company to cover its future cash flow needs. The Company continues to acquire
funds through the Companys S-3 Registration Statement pursuant to which its exclusive placement agent, Chardan Capital
Markets, LLC (Chardan sells shares of common stock at-the-market which is structured to provide up
to $50 million dollars to the Company less certain commissions.
The Company
requires substantial additional capital to finance its planned business operations and expects to incur operating losses in future
periods due to the expenses related to the Companys core businesses. The Company has not realized material revenue since
it commenced doing business in the biotechnology sector, and it is not without doubt that it will be successful in generating
revenues in the future in this sector. The Company believes that cash as of April 30, 2015 and the proceeds from the additional
sale of registered shares will raise sufficient capital to meet its capital requirements. From May 1, 2015 through July 13, 2015;
the Company raised additional capital of approximately $1,220,000 in at-the-market transactions. The Company believes
that the at-the-market sale of its shares will provide sufficient capital to fund its operations through July 31,
2016.
If the Company
is not able to raise substantial additional capital in a timely manner, the Company may not be able to complete its required clinical
trials and may be forced to cease operations.
The Company
will continue to be dependent on outside capital to fund its research and operating expenditures for the foreseeable future. If
the Company fails to generate positive cash flows or fails to obtain additional capital when required, the Company may need to
modify, delay or abandon some or all of its business plans.
Management
Goals and Strategy
The Companys
goal is to have the Company become an industry-leading biotechnology company using the Cell-in-a-Box® live cell
encapsulation technology as a platform upon which treatments for cancer and diabetes can be built.
The Companys
initial strategy is to build upon and advance the success of previous Phase 1/2 and Phase 2 pancreatic cancer clinical trials.
The Companys acquisition of Bio Blue Bird was the first step in this strategy.
The Company
will seek to raise capital to fund growth opportunities and provide for its working capital needs as its strategy is executed.
The Companys strategy to achieve its goals consists of the following:
| · | The
completion of the preparations for the Phase 2b clinical trial in advanced, inoperable
pancreatic cancer to be conducted by CNS in Australia; |
| · | The
completion of the preparations for the clinical trials that will examine the effectiveness
of its pancreatic cancer treatment in ameliorating the pain and accumulation of malignant
ascites fluid in the abdomen that are characteristic of pancreatic cancer. These clinical
trials will be conducted by TD2 in the United States; |
| · | The
completion of preclinical studies that involve the encapsulation of a human cell line
genetically engineered to produce, store and secrete insulin on demand at levels in proportion
to the levels of blood sugar in the human body. The encapsulation will be done using
the Cell-in-a-Box® technology; |
| · | The
enhancement of the Companys ability to expand into the biotechnology arena through
further research and partnering agreements; |
| · | The
acquisition of new contracts that generate revenue or provide research and development
capital utilizing our sublicensing rights; |
| · | The
further development of uses of the Cell-in-a-Box® technology platform
through contracts, licensing agreements and joint ventures with other companies; and |
| · | The
completion of testing, expansion and marketing of existing and newly derived product
candidates. |
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v3.3.1.900
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
12 Months Ended |
Apr. 30, 2015 |
Accounting Policies [Abstract] |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
Principles of Consolidation
and Basis of Presentation
The consolidated
financial statements include the accounts of the Company and its wholly owned subsidiaries. The Company operates independently
and through four wholly-owned subsidiaries: (i) Bio Blue Bird AG (Bio Blue Bird); (ii) Nuvilex Europe Limited (soon
to be renamed PharmaCyte Biotech Europe Limited); (iii) Nuvilex Australia Limited (soon to be renamed PharmaCyte Biotech Australia
Private Limited); and (iv) Viridis Biotech, Inc. (Viridis Biotech) and are prepared in accordance with United States
generally accepted accounting principles (U.S. GAAP) and the rules and regulations of the Securities and Exchange
Commission (Commission). Intercompany balances and transactions are eliminated. The Companys 14.5 % investment
in SG Austria is presented on the cost method of accounting
Use of Estimates
The preparation
of financial statements in accordance with U.S. GAAP requires the use of estimates and assumptions that affect the reported amounts
of assets and liabilities, disclosure of contingent assets and liabilities known to exist as of the date the financial statements
are published and the reported amounts of revenues and expenses during the reporting period. Uncertainties with respect to such
estimates and assumptions are inherent in the preparation of the Companys consolidated financial statements; accordingly,
it is possible that the actual results could differ from these estimates and assumptions, which could have a material effect on
the reported amounts of the Companys consolidated financial position and results of operations.
Goodwill and Intangible Assets
The Company
records the excess of purchase price over the fair value of the identifiable net assets acquired as goodwill and other indefinite-lived
intangibles. The Financial Accounting Standards Board ("FASB") standard on goodwill and other intangible assets prescribes
a two-step process for impairment testing of goodwill and indefinite-lived intangibles, which is performed annually, as well as
when an event triggering impairment may have occurred. The first step tests for impairment, while the second step, if necessary,
measures the impairment. The Company has elected to perform its annual analysis at the end of its reporting year.
Impairment of Long-Lived Assets
The Company
evaluates long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an
asset may not be recoverable. If the estimated future cash flows (undiscounted and without interest charges) from the use of an
asset are less than carrying value, a write-down would be recorded to reduce the related asset to its estimated fair value. No
impairment was identified or recorded during the years ended April 30, 2015, 2014 and 2013.
Earnings
per Share
Basic earnings
(loss) per share are computed by dividing earnings available to common stockholders by the weighted average number of outstanding
common shares during the period. Diluted earnings per share is computed by dividing net income by the weighted average number
of shares outstanding during the period increased to include the number of additional shares of common stock that would have been
outstanding if the potentially dilutive securities had been issued. During April 30, 2015, 2014 and 2013, the Company incurred
losses; therefore the effect of any common stock equivalent would be anti-dilutive during these periods.
Fair Value
of Financial Instruments
For certain
of the Companys non-derivative financial instruments, including cash, accounts payable and accrued expenses, the carrying
amount approximates fair value due to the short-term maturities of these instruments.
Accounting
Standards Codification ("ASC") Topic 820, Fair Value Measurements and Disclosures, requires disclosure
of the fair value of financial instruments held by the Company. ASC Topic 825, Financial Instruments, defines fair
value, and establishes a three-level valuation hierarchy for disclosures of fair value measurement that enhances disclosure requirements
for fair value measures. The carrying amounts reported in the consolidated balance sheets for receivables and current liabilities
each qualify as financial instruments and are a reasonable estimate of their fair values because of the short period of time between
the origination of such instruments and their expected realization and their current market rate of interest. The three levels
of valuation hierarchy are defined as follows:
|
· |
Level 1. Observable inputs such as quoted prices in active markets; |
|
· |
Level 2. Inputs, other than the quoted prices in active markets,
that are observable either directly or indirectly; and |
|
· |
Level 3. Unobservable inputs in which there is little or no market
data, which require the reporting entity to develop its own assumptions. |
The Company
adopted ASC subtopic 820-10, Fair Value Measurements and Disclosures ("ASC 820-10") and Accounting Standards Codification
subtopic 825-10, Financial Instruments ("ASC 825-10"), which permits entities to choose to measure many financial
instruments and certain other items at fair value. Neither of these statements had an impact on the Company's financial position,
results of operations or cash flows. The carrying value of cash, accounts payable and accrued expenses, as reflected in the balance
sheets, approximate fair value because of the short-term maturity of these instruments.
Derivative
Instruments
The Company
issued cashless warrants that are accounted for as a derivative instruments which prevents them from being considered indexed
to the Companys common stock and qualified for an exceptions to derivative accounting.
The Company
recognized the derivative instruments as either assets or liabilities on the accompanying consolidated balance sheets at fair
value. The Company records changes in the fair value (i.e. gains or losses) of the derivatives in the accompanying consolidated
statements of operations.
Revenue
Recognition
Sales of
products and related costs of products sold are recognized when: (i) persuasive evidence of an arrangement exists; (ii) delivery
has occurred; (iii) the price is fixed or determinable; and (iv) collectability is reasonably assured. These terms are typically
met upon the prepayment or invoicing and shipment of products.
Income Taxes
Deferred
taxes are calculated using the liability method whereby deferred tax assets are recognized for deductible temporary differences
and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences.
Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred
tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion
or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes
in tax laws and rates on the date of enactment.
A valuation
allowance is provided for deferred income tax assets when, in managements judgment, based upon currently available information
and other factors, it is more likely than not that all or a portion of such deferred income tax assets will not be realized. The
determination of the need for a valuation allowance is based on an on-going evaluation of current information including, among
other things, historical operating results, estimates of future earnings in different taxing jurisdictions and the expected timing
of the reversals of temporary differences. The Company believes the determination to record a valuation allowance to reduce a
deferred income tax asset is a significant accounting estimate because it is based, among other things, on an estimate of future
taxable income in the United States and certain other jurisdictions, which is susceptible to change and may or may not occur,
and because the impact of adjusting a valuation allowance may be material. In determining when to release the valuation allowance
established against our net deferred income tax assets, the Company considers all available evidence, both positive and negative.
Consistent with the Companys policy, and because of the Companys history of operating losses, the Company does not
currently recognize the benefit of all of our deferred tax assets, including tax loss carry forwards, that may be used to offset
future taxable income. The Company continually assesses its ability to generate sufficient taxable income during future periods
in which deferred tax assets may be realized. If and when the Company believes it is more likely than not that it will recover
its deferred tax assets, the Company will reverse the valuation allowance as an income tax benefit in the statements of operations.
The Company
accounts for its uncertain tax positions in accordance with U.S. GAAP. The purpose of this method is to clarify accounting for
uncertain tax positions recognized. The U.S. GAAP method of accounting for uncertain tax positions utilizes a two-step approach
to evaluate tax positions. Step one, recognition, requires evaluation of the tax position to determine if based solely on technical
merits it is more likely than not to be sustained upon examination. Step two, measurement, is addressed only if a position is
more likely than not to be sustained. In step two, the tax benefit is measured as the largest amount of benefit, determined on
a cumulative probability basis, which is more likely than not to be realized upon ultimate settlement with tax authorities. If
a position does not meet the more likely than not threshold for recognition in step one, no benefit is recorded until the first
subsequent period in which the more likely than not standard is met, the issue is resolved with the taxing authority or the statute
of limitations expires. Positions previously recognized are derecognized when the Company subsequently determines the position
no longer is more likely than not to be sustained. Evaluation of tax positions, their technical merits and measurements using
cumulative probability are highly subjective management estimates. Actual results could differ materially from these estimates.
Research and Development
Research and
development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred.
Costs to acquire technologies, including licenses, that are utilized in research and development and that have no alternative
future use are expensed when incurred. Technology developed for use in our product candidates is expensed as incurred until technological
feasibility has been established.
Under the Cannabis
Licensing Agreement, the Company acquired from Austrianova an exclusive, world-wide license to use the Cell-in-a-Box®
trademark and its associated technology with genetically modified non-stem cell lines which are designed to activate cannabinoids
to develop therapies involving Cannabis.
Under the Cannabis
Licensing Agreement, the Company is required to pay Austrianova an Upfront Payment of $2,000,000. The Company has the right to
make periodic monthly partial payments of the Upfront Payment in amounts to be agreed upon between the parties prior to each such
payment being made. Under the Cannabis Licensing Agreement, the Upfront Payments must be paid in full by no later than June 30,
2015. As of April 30, 2015, the Company has paid Austrianova $1 million of the Upfront Payment. The parties have agreed to an
amendment to the Cannabis Licensing Agreement pursuant to which the balance of the Upfront Payment will be due by December 31,
2015. That amendment is in the process of being documented. The $2 million cost of the license has been recorded as research and
development costs.
Stock-Based Compensation
The Companys
stock-based employee compensation awards are described in Note 9. The Company has adopted the provisions of ASC 718, which requires
the fair value measurement and recognition of compensation expense for all stock-based awards made to directors, executives and
employees.
Concentration of Credit Risk
The Company
has no significant off-balance-sheet concentrations of credit risk such as foreign exchange contracts, options contracts or other
foreign hedging arrangements. The Company maintains most of its cash balance at a financial institution located in California.
Accounts at this institution are insured by the Federal Deposit Insurance Corporation up to $250,000. Uninsured balances aggregated
approximately $2,450,000 at April 30, 2015. The Company has not experienced any losses in such accounts, and management believes
it is not exposed to any significant credit risk on cash.
Foreign
Currency Translation
The Company
translates the financial statements of its foreign subsidiary from the local (functional) currencies to US dollars in accordance
with FASB ASC 830, Foreign Currency Matters. All assets and liabilities of the Companys foreign subsidiaries are
translated at year-end exchange rates, while revenue and expenses are translated at average exchange rates prevailing during the
year. Adjustments for foreign currency translation fluctuations are excluded from net income and are included in other comprehensive
loss. Gains and losses on short-term intercompany foreign currency transactions are recognized as incurred.
Reclassification
Certain prior
year balances have been reclassified to conform to the 2015 presentation, with no changes in net loss for prior periods presented.
Recent
Accounting Pronouncements
In May 2014,
the FASB issued ASU No. 2014-09 "Revenue from Contracts with Customers" (Topic 606). Topic 606 supersedes
the revenue recognition requirements in Topic 605, Revenue Recognition, including most industry-specific
revenue recognition guidance throughout the Industry Topics of the Codification. In addition, the amendments create a new
Subtopic 340-40, Other Assets and Deferred CostsContracts with Customers. In summary, the core principle
of Topic 606 is that an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount
that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. For a public
entity, the amendments in this Update are effective for annual reporting periods beginning after December 15, 2016, including
interim periods within that reporting period; early application is not permitted. The Company is currently evaluating the impact
this guidance will have on its consolidated financial position and consolidated statement of operations.
In June 2014,
the FASB issued ASU No. 2014-12, "Compensation - Stock Compensation (Topic 718)," which makes amendments to the
codification topic 718, "Accounting for Share-Based Payments," when the terms of an award provide that a performance
target could be achieved after the requisite service period. The new guidance becomes effective for annual reporting periods beginning
after December 15, 2015; early adoption is permitted. The Company is currently evaluating the impact this guidance will have on
its consolidated financial position and results of operations.
In August
2014, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2014-15,
Presentation of Financial Statements Going Concern, Subtopic 205-40, Disclosure of Uncertainties
about an Entitys Ability to Continue as a Going Concern. The amendments in this ASU apply to all entities
and require management to assess an entitys ability to continue as a going concern by incorporating and expanding upon
certain principles that are currently in U.S. auditing standards. Specifically, the amendments: (i) provide a definition of the
term substantial doubt; (ii) require an evaluation every reporting period including interim periods; (iii) provide
principles for considering the mitigating effect of managements plans; (iv) require certain disclosures when substantial
doubt is alleviated as a result of consideration of managements plans; (v) require an express statement and other
disclosures when substantial doubt is not alleviated; and (vi) require an assessment for a period of one year after the date that
the financial statements are issued or available to be issued. The amendments in this Update are effective for the annual period
ending after December 15, 2016. For annual periods and interim periods thereafter; early application is permitted. The Company
is currently evaluating the impact this guidance will have on its consolidated financial position and results of operations.
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v3.3.1.900
4. BUSINESS ACQUISITION
|
12 Months Ended |
Apr. 30, 2015 |
Equity Method Investments and Joint Ventures [Abstract] |
|
BUSINESS ACQUISITION |
Effective
as of June 25, 2013, the Company completed the purchase of Bio Blue Bird. Shares for both Austrianova and the Company originally
held in escrow under the SG Austria APA were returned to the original owners. The 100,000,000 shares of the Company were cancelled. The
acquisition was accounted for under ASC Topic 805, Business Combination. Accordingly, the assets and liabilities
were fair valued and purchase accounting applied.
The assets
of Bio Blue Bird are licenses related to the Cell-in-a-Box® technology with a fair value of $1,549,427. The assets
acquired were accounted for at the fair value at the acquisition date based on current information that management believes is
reasonable. After the acquisition, Bio Blue Bird became a wholly-owned subsidiary of the Company.
Since the
Companys acquisition of Bio Blue Bird, no revenues have been generated from the licenses; therefore, no pro-forma information
has been prepared. The licenses will be used in the development of the Companys product candidate in advanced pancreatic
cancer.
|
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- DefinitionThe entire disclosure for equity method investments and joint ventures. Equity method investments are investments that give the investor the ability to exercise significant influence over the operating and financial policies of an investee. Joint ventures are entities owned and operated by a small group of businesses as a separate and specific business or project for the mutual benefit of the members of the group.
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v3.3.1.900
5. ACCRUED EXPENSES
|
12 Months Ended |
Apr. 30, 2015 |
Payables and Accruals [Abstract] |
|
ACCRUED EXPENSES |
Accrued expenses at April 30,
2015 and 2014 are summarized below:
| |
2015 | | |
2014 | |
Accrued interest | |
$ | | | |
$ | 33,960 | |
Deferred rent | |
| 1,480 | | |
| | |
Payroll related costs | |
| 19,539 | | |
| | |
Other | |
| 2,648 | | |
| 7,803 | |
Total | |
$ | 23,667 | | |
$ | 41,763 | |
|
X |
- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
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v3.3.1.900
6. DEBT
|
12 Months Ended |
Apr. 30, 2015 |
Debt Disclosure [Abstract] |
|
DEBT |
In November,
2013, the Company settled its obligation to pay $400,000 in licensing fees, for a licensing agreement terminated in 2009 with
the issuance of 2,000,000 shares of common stock. The shares were valued at $226,000 using the closing share price of the common
stock on the day of issuance resulting in a gain on settlement of debt of $174,000.
In February,
2014, the Company settled its obligation to pay $20,000 plus $6,000 of accrued interest to a note holder with the issuance of
250,000 shares of common stock. The shares were valued $45,500 using the closing share price of the common stock on the day of
issuance resulting in a loss on settlement of debt of $19,500.
In December
2014, the Company entered into a licensing agreement for a license to use the Cell-in-a-Box® technology to develop
therapies involving Cannabis. As of the date of this Report, the Company has paid $1,000,000 of a required $2,000,000 payment
for the license.
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.3.1.900
7. COMMON STOCK TRANSACTIONS
|
12 Months Ended |
Apr. 30, 2015 |
Equity [Abstract] |
|
COMMON STOCK TRANSACTIONS |
The Company
has amended and restated two disclosures relating to common stock transactions. The first disclosure correction relates to the
issuance of options to directors and officers to purchase 25 million shares of common stock. The disclosure was restated to reflect
that the current period non-cash compensation expense was $3,629,731 rather than the $4,307,822 as originally reported in the
consolidated statements of operations for the year ended April 30, 2015 contained in the Original Filing. The second disclosure
correction relates to the issuance of 400,000 shares of common stock to two officers of the Company as compensation during the
year ended April 30, 2015 that was originally reported as an issuance of 600,000 shares. The disclosure was restated to
reflect that the current period non-cash expense was $87,200 rather than $133,440 as reported in the consolidated statements of
operations for the year ended April 30, 2015 contained in the Original Filing and to remove the mention of the issuance of 2,400,000
shares of common stock issued to two officers that was included in a separate disclosure.
During the year
ended April 30, 2013, 8,771,429 shares of common stock were issued for various services. The shares were valued using the closing
stock price on the day of issuance for a total expense of $331,000.
During the year
ended April 30, 2013, 3,592,656 shares of common stock were issued to settle various debts. The shares were valued using the closing
stock price on the day of issuance for a total expense of $143,596.
During the year
ended April 30, 2013, 13,326,668 shares of common stock were issued to officers of the Company for compensation. The shares were
valued using the closing stock price on the day of issuance for a total expense of $653,696.
During the year
ended April 30, 2013, 500,000 shares of common stock were issued for $10,000 cash.
During the year
ended April 30, 2013 the Company issued 39,622,400 shares of common stock for proceeds of $1,136,000, which were sold through
the Company's Private Placement Memorandum at approximately $0.03 per share.
In May 2013,
75,000 shares of common stock were issued to settle debt of $32,392. The shares were valued using the closing share price of the
common stock of the day of issuance, resulting in a gain on settlement of $21,142.
During the year
ended April 30, 2014, a shareholder converted 8,500 shares of the Companys Series E Preferred Stock (see Note 8) into 54,000,000
shares of common stock. The shares were valued using the closing share price of the common stock on the day of issuance for a
total of $6,475,000 resulting in a loss on conversion of $5,895,000.
During the year
ended April 30, 2014, 52,370,000 shares of common stock were issued to officers and directors of the Company for compensation.
These shares were valued using the closing share price of the common stock on the day of issuance for a total non-cash expense
of $14,101,788.
During the year
ended April 30, 2014, 13,756,666 shares of common stock were issued to consultants for services rendered to the Company. The shares
were valued using the closing share price of the common stock price on the day of issuance for a total non-cash expense of $1,810,348.
As of April 30, 2014, $528,808 of this expense had been deferred to prepaid expenses and will be expensed to future periods as
determined by the term of each agreement.
During the year
ended April 30, 2014, the Company sold 27,000,000 shares of common stock for $4,918,000. As of April 30, 2014, 17,000,000 of these
shares had not yet been issued and were disclosed as common stock to be issued.
During the year
ended April 30, 2014, the Company converted some of its Class A and Class B warrants into 19,649,600 shares of common stock for
$1,592,880.
On February 14,
2014, the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC (Lincoln Park). Lincoln
Park initially purchased 8 million shares of common stock at $0.25 per share for $2 million and had committed to invest up to
an additional $25 million of equity capital over the term of the purchase agreement. As consideration for its commitment to purchase
shares of common stock pursuant to the purchase agreement, the Company issued to Lincoln Park 5,062,500 shares of common stock
upon execution of the purchase agreement. These shares were valued at $0.169, the closing price of the stock on February 14, 2014,
for non-cash expense of $855,653. On May 28, 2014 the Company and Lincoln Park executed a Mutual Termination and Release Agreement
releasing all parties from certain obligation under the purchase agreement. As consideration for terminating the purchase agreement,
the Company issued Lincoln Park an additional 1,062,500 shares of common stock. These shares were valued at $0.28 for total non-cash
expense of $297,500.
During the year
ended April 30, 2015, 300,000 shares of common stock were issued to an officer of the Company for compensation. The shares were
valued using the closing share price of the common stock on the day of issuance for a total non-cash expense of $86,100.
During the year
ended April 30, 2015, the Company sold 200,000 shares of common stock for $20,000.
During the year
ended April 30, 2015, the Company converted some of its Class B warrants into 550,000 shares of common stock for $66,000.
During the year
ended April 30, 2015, 17,628,000 shares of common stock were issued to fully satisfy all stock payables due in the amount of $1,574,860.
During the year
ended April 30, 2015, the Company had committed to issue 1,700,000 shares of common stock to officers as part of their employment
agreements. The shares were valued using the closing share price of the common stock on the date the accrual of the compensation
for a total of a non-cash expense of $394,250.
During the year
ended April 30, 2015, the Company, as a result of settlement agreements, accepted the return of 15,606,667 shares of its common
stock from three officers. The Company adopted subtopic ASC 845-10-30 Treasury Stock Acquisition in Connection with
a Settlement Agreement to account for the shares the Company received. The shares were valued at the closing price
on date of their return. The Company recognized a non-cash gain equal to the fair value of the shares in the amount of $3,337,967
and is included in other income, net in the consolidated statements of operations.
During the year
ended April 30, 2015, the Company entered into a mutual termination agreement with a consultant. The original consulting agreement
called for the issuance of 800,000 shares. The mutual termination agreement resulted in a return of 335,296 shares of the 800,000
share issued. The Company adopted subtopic ASC 845-10-30 to account for the shares returned. The shares were valued at the closing
price on the date the mutual termination agreement was signed. The Company recognized a non-cash gain of $74,436, which is included
in consulting expense in the consolidated statements of operations.
During the
year ended April 30, 2015, the Company issued options to purchase 25 million shares to officers and directors. The options vested
immediately and expire on September 30, 2019 and are exercisable at $0.19 per share. The grant of these options resulted in a
current period expense of $3,629,731 and is included as a compensation expense in the consolidated statements of operations.
During the
year ended April 30, 2015, 400,000 shares of common stock were issued to two officers of the Company for compensation. The shares
were valued using the closing share price of the common stock on the day of the issuance for a total non-cash expense of $87,200.
During the year
ended April 30, 2015, the Company issued 7,284,150 shares of common stock to consultants. The non-cash expense for these share
issuances total $972,206.
During the year
ended April 30, 2015, the Company issued 3,600,000 shares of common stock to officers as part of their compensation agreements.
These shares vest on quarterly basis over a twelve-month period. The 900,000 shares that vested were valued at the date of vesting
and resulted in a non-cash compensation expense of $125,460.
During the year
ended April 30, 2015, the Company issued 1,200,000 shares of common stock to an employee as part of an employee agreement. These
shares vest on quarterly basis over a twelve-month period. The 300,000 shares that vested were valued at the date of vesting and
resulted in a non-cash expense of $41,820.
All shares were
issued without registration under the Securities Act of 1933, as amended (Securities Act), in reliance upon the
exemption afforded by Section 4(a)(2) of the Act.
On October 24,
2014, the Company completed a $50 million underwritten public offering. During the year ended April 30, 2015 the Company sold
and issued approximately 24.2 million shares of common stock at prices ranging from $0.10 to $0.24 per share. Net of underwriting
discounts, legal, accounting and other offering expenses, the Company received proceeds of approximately $3.7 million from the
sale of these shares.
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- DefinitionThe entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.
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v3.3.1.900
8. PREFERRED STOCK
|
12 Months Ended |
Apr. 30, 2015 |
Equity [Abstract] |
|
PREFERRED STOCK |
The Company
has one authorized series of preferred stock designated as "Series E Preferred Stock." The Series E Preferred Stock
has the following features:
|
|
Series E Preferred Stock does not bear any dividends; |
|
|
Each share of Series E Preferred Stock is entitled
to receive its share of assets distributable upon the liquidation, dissolution or winding up of the affairs of the Company.
The holders of the Series E Preferred Stock are entitled to receive cash out of the assets of the Company before any amount
is paid to the holders of any capital stock of the Company of any class junior in rank to the shares of Series E Preferred
Stock; |
|
|
Each share of Series E Preferred Stock is convertible,
at the holders option, into shares of common stock, at the average closing bid price of the common stock for five trading
days prior to the conversion date; and |
|
|
At every meeting of stockholders, every holder of
shares of Series E Preferred Stock is entitled to 50,000 votes for each share of Series E Preferred Stock, with the same and
identical voting rights as a holder of a share of common stock. |
During the
year ended April 30, 2014, a shareholder converted 8,500 shares of the Companys Series E Preferred Stock (consisting of
all outstanding shares of Series E Preferred Stock) into 54,000,000 shares of common stock. These shares were valued using the
closing share price of the common stock on the day of issuance for a total of $6,475,000 resulting in a loss on conversion of
$5,895,000. There are no shares of Series E Preferred Stock currently outstanding.
Holders of
Series E Preferred Stock have specific rights to be paid in cash out of the assets of the Company prior to any junior class of
common stock. As a result of the obligations for Series E Preferred Stock, the Company has determined these redemption features
have the potential to be outside the control of the Company and, therefore, the Company has classified the Series E Preferred
Stock outside of shareholders equity in accordance with ASC 480 regarding instruments with debt and equity features. Thus, the
full value for the convertible Series E Preferred Stock was recorded outside of stockholders equity in the accompanying
consolidated financial statements.
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v3.3.1.900
9. STOCK OPTIONS AND WARRANTS
|
12 Months Ended |
Apr. 30, 2015 |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] |
|
STOCK OPTIONS AND WARRANTS |
Stock Options
The Company
granted stock options to its directors, officers and an employee during the year ended April 30, 2015, based on compensation and
director agreements.
The Company
has adopted the provisions of ASC 718, Compensation-Stock, which requires the measurement and recognition
of compensation expense for all stock-based awards made to employees.
The fair
value of the stock options at the date of grant was estimated using the Black-Scholes option-pricing model, based on the following
assumptions:
| |
April 30, | |
| |
2015 | | |
2014 | | |
2013 | |
Risk-free interest rate | |
| 2 | % | |
| | | |
| | |
Expected volatility | |
| 145 | % | |
| | | |
| | |
Expected lives (years) | |
| 2.7 | | |
| | | |
| | |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % | |
| 0.00 | % |
The Companys
computation of expected volatility is based on the historical daily volatility of its publicly traded stock. For stock option
grants issued during years ended April 30, 2015, 2014 and 2013, the Company used a calculated volatility for each grant. The Company
lacks adequate information about the exercise behavior at this time and has determined the expected term assumption under the
simplified method provided for under ASC 718, which averages the contractual term of the Companys stock options of five
years with the average vesting term of two and one half years for an average of three years. The dividend yield assumption of
zero is based upon the fact the Company has never paid cash dividends and presently has no intention of paying cash dividends.
The risk-free interest rate used for each grant is equal to the U.S. Treasury rates in effect at the time of the grant for instruments
with a similar expected life. Based on historical experience, for the year ended April 30, 2015, the Company has estimated an
annualized forfeiture rate of 5% for stock options granted to its employees, 5% for stock options granted to officers and 5% for
stock options granted to directors. Compensation costs will be adjusted for future changes in estimated forfeitures. The Company
will record additional expense if the actual forfeitures are lower than estimated and will record a recovery of prior expense
if the actual forfeiture rates are higher than estimated. No amounts relating to employee stock-based compensation have been capitalized.
At April
30, 2015, there remained approximately $533,000 of unrecognized compensation expense related to unvested stock options granted
to current and former employees and directors, to be recognized as expense over a weighted-average period of one year.
Presented
below is the Companys stock option activity for employees and directors:
The weighted
average fair value of stock options granted during the years ended April 30, 2015, 2014 and 2013 are $0.10, $0.00 and $0.00, respectively.
A summary
of the activity for unvested employee stock options during the three years ended April 30, 2015 is presented below:
| |
| Options
Outstanding | | |
| Weighted
Average Grant Date Fair Value per Share | |
Nonvested, April 30, 2012 | |
| | | |
$ | | |
Granted | |
| | | |
| | |
Vested | |
| | | |
| | |
Forfeited | |
| | | |
| | |
Nonvested, April 30, 2013 | |
| | | |
| | |
Granted | |
| | | |
| | |
Vested | |
| | | |
| | |
Forfeited | |
| | | |
| | |
Nonvested, April 30, 2014 | |
| | | |
| | |
Granted | |
| 47,200,000 | | |
$ | 0.14 | |
Vested | |
| 40,600,000 | | |
| 0.15 | |
Forfeited | |
| | | |
| | |
Nonvested, April 30, 2015 | |
| 6,600,000 | | |
$ | 0.10 | |
The Company
recorded approximately $5,237,000, $0 and $0 of non-cash charges related to the issuance of stock options to certain directors
and employees in exchange for services during the years ended April 30, 2015, 2014 and 2013, respectively.
At April
30, 2015, there remained approximately $558,000 (subject to change in the future based on vesting date fair value) of unrecognized
compensation expense related to unvested employee stock options to be recognized as expense over a weighted-average period of
one year.
Presented below is the Companys
employee stock option activity during the three years ended April 30, 2015:
| |
| Options
Outstanding | | |
| Weighted
Average Grant Date Fair Value per Share | |
Nonvested, April 30, 2012 | |
| | | |
$ | | |
Granted | |
| | | |
| | |
Vested | |
| | | |
| | |
Forfeited | |
| | | |
| | |
Nonvested, April 30, 2013 | |
| | | |
| | |
Granted | |
| | | |
| | |
Vested | |
| | | |
| | |
Forfeited | |
| | | |
| | |
Nonvested, April 30, 2014 | |
| | | |
| | |
Granted | |
| 5,250,000 | | |
$ | 0.19 | |
Vested | |
| 5,250,000 | | |
| 0.19 | |
Forfeited | |
| | | |
| | |
Nonvested, April 30, 2015 | |
| | | |
$ | | |
The following
table summarizes ranges of outstanding stock options at April 30, 2015:
| |
Exercise Prices | |
Range of Exercise Price | |
$ | 0.19 | | |
$ | 0.11 | | |
$ | 0.18 | |
Number of Options | |
| 25,000,000 | | |
| 27,200,000 | | |
| 250,000 | |
Weighted Average Remaining Contractual Life (years) | |
| 4.42 | | |
| 4.67 | | |
| 4.98 | |
Weighted Average Stock Price | |
$ | 0.19 | | |
$ | 0.10 | | |
$ | 0.18 | |
Number of Options Exercisable | |
| 25,000,000 | | |
| 27,200,000 | | |
| 250,000 | |
Weighted Average Contractual Life (years) | |
| 5 | | |
| 5 | | |
| 5 | |
Weighted Average Exercise Price | |
$ | 0.19 | | |
$ | 0.10 | | |
$ | 0.18 | |
The aggregate
intrinsic value of outstanding options as of April 30, 2015 was approximately $1,360,000. This represents options whose exercise
price was less than the closing fair market value of the Companys common stock on April 30, 2015 of $0.16 per share.
Warrants
(As Restated)
The Company
issued certain warrants to purchase common stock with a cashless exercise feature (cashless warrants) in connection
with its entry into a marketing and consulting agreement (Consultant Agreement) with a consultant on March 23, 2015.
The Company accounted for the cashless warrants as a derivative liability, as disclosed in the Original Filing. However, upon
further analysis, the Company determined that the cashless warrants should have been accounted for as equity in accordance with
U.S. GAAP in the Original Filing. Additionally, the Company determined that the Consultant Agreement, issuance of shares
of common stock to the consultant pursuant to the Consultant Agreement and the issuance of certain warrants to purchase common
stock with a cash exercise feature (cash warrants) and the cashless warrants to the consultant should have been
recorded as a prepaid asset and amortized over the term of the Consultant Agreement in accordance with U.S. GAAP in the Original
Filing.
The warrants
issued by the Company are classified as equity. The fair value of the warrants was recorded as additional-paid-in-capital, and
no further adjustments are made.
On January
21, 2014, the Company began the implementation of its Warrant Conversion Program. The program consists of offering
every holder of Class A warrants the ability to exercise their Class A warrants, with an exercise price of $0.075 per share, into
shares of common stock and an equal number of new Class D warrants, with an exercise price of $0.25 per warrant share. As
of April 30, 2015, 18,755,200 Class A warrants were converted for total cash proceeds of $1,380,720 and conversion of $25,920
of debt to an officer. The Company has also begun to offer holders of its Class B warrants, with a conversion price of $0.12 per
share, with the same terms. As of April 30, 2015, 2,318,000 Class B warrants were exercised for total cash proceeds of $278,160.
An aggregate of 18,755,200 Class D Warrants have been issued in connection with this program.
On September
1, 2014 the Company granted 854,308 Class D Warrants to purchase common stock as part of the Warrant Conversion Program. This
resulted in an expense of $100,000 under a consulting agreement to facilitate the Warrant Conversion Program. This expense is
included in general and administrative expense.
On March 23,
2015, the Company granted 5,000,000 warrants to purchase common stock at an exercise price of $0.11 per share, which expire on
December 31, 2015.
On March 23,
2015, the Company granted 10,000,000 cashless warrants to acquire stock at an exercise price of $0.11 per share, which expire
on March 23, 2020.
For stock
warrants paid in consideration of services rendered by non-employees, the Company recognizes consulting expense in accordance
with the requirements of ASC 505-50 and ASC 505, as amended.
A summary
of the Companys warrant activity and related information for the three years ended April 30, 2015 are shown below:
| |
| Warrants | | |
| Weighted
Average Price | | |
| Weighted
Average Fair Value | |
Outstanding, April 30, 2012 | |
| | | |
$ | | | |
$ | | |
Issued | |
| 59,433,600 | | |
| 0.125 | | |
| 0.064 | |
Exercised | |
| | | |
| | | |
| | |
Outstanding, April 30, 2013 | |
| 59,433,600 | | |
| 0.125 | | |
| 0.064 | |
Issued | |
| | | |
| | | |
| | |
Exercised | |
| (1,768,000 | ) | |
| | | |
| | |
Outstanding, April 30, 2014 | |
| 57,665,600 | | |
| 0.18 | | |
| 0.065 | |
Issued | |
| 15,854,308 | | |
| | | |
| | |
Exercised | |
| (550,000 | ) | |
| | | |
| | |
Outstanding, April 30, 2015 | |
| 72,969,908 | | |
| | | |
| | |
Exercisable, April 30, 2015 | |
| 72,969,908 | | |
$ | 0.17 | | |
$ | 0.075 | |
There were
no cashless exercises of warrants on April 30, 2015 and 2014.
The
following table summarizes additional information concerning warrants outstanding and exercisable at April 30, 2015:
Range of Exercise Prices | |
Number of Warrant
Shares Exercisable at 04/30/2015 | | |
Weighted Average
Remaining Contractual Life | | |
Exercisable Weighted
Average Exercise Price | |
$0.075, $0.11, $0.12, $0.18 and $0.25 | |
| 72,969,908 | | |
| 2.86 | | |
| 0.17 | |
| |
| | | |
| | | |
| | |
Five Year Term - $0.075 | |
| 1,056,000 | | |
| 2.45 | | |
| | |
Five Year Term - $0.12 | |
| 18,347,508 | | |
| 2.75 | | |
| | |
Five Year Term - $0.18 | |
| 19,811,200 | | |
| 2.67 | | |
| | |
Five Year Term - $0.25 | |
| 18,755,200 | | |
| 2.68 | | |
| | |
Five Year Term - $0.11 | |
| 10,000,000 | | |
| 4.90 | | |
| | |
Nine Month Term - $0.11 | |
| 5,000,000 | | |
| 0.67 | | |
| | |
| |
| 72,969,908 | | |
| | | |
| | |
|
X |
- DefinitionThe entire disclosure for compensation-related costs for equity-based compensation, which may include disclosure of policies, compensation plan details, allocation of equity compensation, incentive distributions, equity-based arrangements to obtain goods and services, deferred compensation arrangements, employee stock ownership plan details and employee stock purchase plan details.
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v3.3.1.900
10. LEGAL PROCEEDINGS
|
12 Months Ended |
Apr. 30, 2015 |
Commitments and Contingencies Disclosure [Abstract] |
|
LEGAL PROCEEDINGS |
The Company
is not currently a party to any pending legal proceedings, material or otherwise. There are no legal proceedings to which any
property of the Company is subject. However, in the past the Company has been the subject of litigation, claims and assessments
arising out of matters occurring in its normal business operations. In the opinion of management, none of these had a material
adverse effect on the Companys consolidated financial position, operations and cash flows.
A summary
of past litigation and claims which have been resolved follows:
The Settlement
Agreement with Cornerstone Bank, entered into on or about May 7, 2012, concluded a prior material legal proceeding. The settlement
with Cornerstone Bank was fully satisfied with cash proceeds of $702,061 received by Cornerstone Bank through the sale of 6,374,977
of the 14,605,614 total shares of stock collateral that was held by them. Collateral held by Cornerstone in the form of 8,230,637
shares of common stock was returned to the Company. These shares were transferred to a third party as compensation for professional
fees to be provided. The shares were valued at the closing price of the stock on the date of the final settlement agreement for
total non-cash expense of $1,160,520. All obligations to Cornerstone have been satisfied. As a result of writing off the
liability due to Cornerstone totaling $2,341,106 and the building asset and the accumulated depreciation totaling $1,028,778,
the Company recognized a gain on settlement of debt of $1,312,328.
During the
period January 1, 2012 through March 31, 2013, Pauline M. Muggli (Muggli), doing business as Internet Pro Designs,
and Ron Simper (Simper) provided information technology consulting services (IT Services) to the Company.
Muggli submitted invoices to the Company for IT Services allegedly performed at the request of the Company in excess of $60,000
(IT Invoices). The Company disputed the IT Services and the amount of the IT Invoices. Effective October 23, 2013,
the Company, Muggli and Simper entered into a settlement agreement pursuant to which the Company paid Muggli $3,000 in cash and
issued 141,667 shares of common stock in exchange for a release of all claim that either Muggli or Simper have against the Company.
The Company provided a similar release of all claims against Muggli and Simper. The settlement has been fully implemented. The
cash consideration has been paid and the shares of common stock have been issued to Muggli and the mutual general releases are
in effect.
Freedom-2,
Inc. and The General Hospital Corporation (General Hospital) are parties to a Master Agreement dated October 1,
1999 and associated License Agreement (collectively, MGH Agreements). Since entering into the MGH Agreements, Freedom-2
became a wholly owned subsidiary of the Company. General Hospital claimed that Freedom-2 owed General Hospital $69,095 under the
MGH Agreements (Debt). The Company and Freedom-2, Inc. denied liability for the Debt, but elected to resolve the
dispute without becoming involved in time consuming and costly litigation. Effective November 1, 2013, a settlement agreement
was entered into between General Hospital, the Company and Freedom-2, Inc., pursuant to which all of the Companys rights
to five patents related to permanent, removable tissue markings were transferred to General Hospital. In exchange, General Hospital
provided a general release of all claims, including the Debt. The Company provided General Hospital a general release of all claims.
The settlement has been consummated and the mutual general releases are in effect.
The
Companys wholly owned subsidiary Freedom-2, Inc. and Brown University are parties to an Intellectual Property
License Agreement dated May 16, 2009. Brown University asserted a claim against the Company and Freedom-2, Inc. for $400,000
under the Property License Agreement. Although the Company and Freedom-2, Inc. denied liability, they nevertheless wanted
to resolve the dispute without becoming embroiled in time consuming and costly litigation. Effective December 9, 2013
a settlement agreement was entered into between Brown University, the Company and Freedom-2, Inc. pursuant to which the
parties released each other for all claims relating to the Property License Agreement. In addition, the Company agreed to
issue 2,000,000 shares of common stock to Brown University to consummate the settlement. The shares were valued at $0.11 per
share. The shares of common stock have been issued and the settlement has been concluded.
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- DefinitionThe entire disclosure for legal proceedings, legal contingencies, litigation, regulatory and environmental matters and other contingencies.
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v3.3.1.900
11. RELATED PARTY TRANSACTIONS
|
12 Months Ended |
Apr. 30, 2015 |
Related Party Transactions [Abstract] |
|
RELATED PARTY TRANSACTIONS |
The Company had the following
related party transactions:
As of
April 30, 2015, 2014 and 2013, the Company owed Berkshire Capital $0, $0 and $393,158, respectively, for operating expenses.
Berkshire Capital was, at certain times when such amounts were outstanding, the holder of more than 5% of our outstanding
shares of common stock. The highest amount outstanding during the fiscal year ended April 30, 2013 and 2014 were $393,158 and
$471,011, respectively. All loans bear interest at 6% and were due within one to three years. During the fiscal year ended
April 30, 2013, the Company did not make any payments on these loans. During the fiscal year ended April 30, 2014, the
Company repaid $471,011 of principal and $30,195 in accrued interest with the issuance of 26 million shares of common stock.
The shares were issued at prices ranging from $0.14 to $0.18.
As of April
30, 2015, 2014 and 2013, the Company owed the Companys former Chief Financial Officer and Chairman of the Board, Patricia
Gruden, $0, $0 and $23,200 in principal and $2,740 in interest, for a total of $25,940; respectively, for a loan she made to the
Company in 2011. The loan bore interest at 8% and was due on demand. The highest amount outstanding during the fiscal year ended
April 30, 2013 was $25,940. During the year ended April 30, 2014, the Company paid the outstanding principal balance of $23,200
and accrued interest of $4,117.
As of April 30,
2013, the Company owed Dr. Robert F. Ryan, our former Chief Scientific Officer and former Chief Executive Officer, $201,143 of
principal and $20,171 of accrued interest on a loan that is due on demand and accruing interest at 8% per year. The highest amount
outstanding occurred during the fiscal year ended April 30, 2013 and totaled $283,743. During the year ended April 30, 2013, the
Company made principal payments totaling $95,600 and no interest payments in respect of this loan. During the year ended April
30, 2014, the Company repaid $35,095 of principal in cash and converted $25,920 of principal to common stock. No payments were
made towards accrued interest. As of April 30, 2014, the balance on this loan was $140,143 of principal and $33,960 of accrued
interest. During the year ended April 30, 2015, the Company repaid an additional $20,000 of principal. Effective as of September
19, 2014, Dr. Ryan resigned from the Board and from his position as the Chief Scientific Officer of the Company. In connection
with his departure, the Company entered into the Settlement Agreement pursuant to which the Company paid Dr. Ryan $183,000, which
included accrued interest of $38,685 in settlement of the full amount of his loan.
The Company owns
14.5% of the equity in SG Austria and is reported on the cost method of accounting. The Company paid SG Austria a one-time manufacturing
setup fee, as required by the Third Addendum, in two installments in the amounts of $323,500 and $323,500 in the years ended April
30, 2015 and 2014, respectively. In addition, SG Austria has two subsidiaries: (i) Austrianova; and (ii) Austrianova Thailand
Ltd. The Company purchased products from these subsidiaries in the approximate amount of $63,000.
Effective April
1, 2014, the Company entered into a consulting agreement with Vin-de-Bona Trading Company Pte Ltd (Vin-de-Bona)
pursuant to which Vin-de-Bona agreed to provide professional consulting services to the Company. Vin-de-Bona is owned by Prof.
Dr. Walter H. Günzburg and Dr. Brian Salmons. The term of the agreement is for 12 months, automatically renewable for successive
12 month terms. After the initial term, either party can terminate the agreement by giving the other party 30 days written notice
before the effective date of termination. The amount paid as of April 30, 2015 is approximately $97,000. In addition, the Company
has issued 500,000 shares of common stock in connection with Dr. Gunzburgs services as the Chief Scientific Officer of
the Company and 250,000 shares to Dr. Salmons for his services on the Companys Scientific Advisory Board.
Under the Cannabis
Licensing Agreement, the Company acquired from Austrianova an exclusive, world-wide license to use the Cell-in-a-Box®
trademark and its associated technology with genetically modified non-stem cell lines which are designed to activate cannabinoids
to develop therapies involving Cannabis.
Under the Cannabis
Licensing Agreement, the Company is required to pay Austrianova an Upfront Payment of $2,000,000. The Company has the right to
make periodic monthly partial payments of the Upfront Payment in amounts to be agreed upon between the parties prior to each such
payment being made. Under the Cannabis Licensing Agreement, the Upfront Payments must be paid in full by no later than June 30,
2015. As of April 30, 2015, the Company has paid Austrianova $1 million of the Upfront Payment. The parties have agreed to an
amendment to the Cannabis Licensing Agreement pursuant to which the balance of the Upfront Payment will be due by December 31,
2015. That amendment is in the process of being documented. The $2 million cost of the license has been recorded as research and
development costs.
During the
year ended April 30, 2015, the Company issued stock options to directors and officers (see Note 9).
With the
exception of Thomas Liquard, the Board has determined that none of the Companys directors satisfies the definition of Independent
Director as established in the NASDAQ Marketplace Rules. Mr. Liquard has been determined by the Board to be an Independent Director.
|
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- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.3.1.900
12. COMMITMENTS AND CONTINGENCIES
|
12 Months Ended |
Apr. 30, 2015 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
The Company
acquires assets still in development and enters into research and development arrangements with third parties that often require
milestone and royalty payments to the third party contingent upon the occurrence of certain future events linked to the success
of the asset in development. Milestone payments may be required, contingent upon the successful achievement of an important point
in the development life-cycle of the pharmaceutical product (e.g., approval of the product for marketing by a regulatory agency).
If required by the license agreements, the Company may have to make royalty payments based upon a percentage of the sales of the
pharmaceutical products in the event that regulatory approval for marketing is obtained.
Office
Lease
The Company
currently leases office space at 12510 Prosperity Drive, Suite 310, Silver Spring, Maryland 20904. The current lease is due to
expire on July 31, 2016. Rent expense for the years ended April 30, 2015, 2014 and 2013 were $49,250, $49,085 and $56,763, respectively.
April 30, Year ending, | |
Amount | |
2016 | |
$ | 51,117 | |
2017 | |
| 12,873 | |
| |
$ | 63,990 | |
Licensing Agreements
Diabetes Licensing Agreement
The Diabetes
Licensing Agreement requires the Company to pay a fee for producing the final encapsulated cell product of $633.14 per vial of
300 capsules after production with a minimum purchased batch size of 400 vials of any Cell-in-a-Box® product.
The Diabetes
Licensing Agreement requires the Company to make future royalty and milestone payments as follows: (i) ten percent royalty of
the gross sale of all products the Company sells; (ii) twenty percent royalty of the amount actually received by the Company from
sub-licensees on sub-licensees gross sales; (iii) milestone payments of $100,000 within 30 days of beginning the first
pre-clinical experiments using the encapsulated cells; (iv) $500,000 within 30 days after enrollment of the first human patient
in the first clinical trial; (v) $800,000 within 30 days after enrollment of the first human patient in the first Phase 3 clinical
trial; and(vi) $1,000,000 due 60 days after having a NDA or a BLA approved by the FDA or a MAA approved in Europe or its equivalent
based on the country in which it is accepted for each product.
Melligen
Cell License Agreement
The Melligen
Cell License Agreement does not require any up-front payment to UTS. The Company is required to pay to UTS a patent
administration fee amounting to 15% on all amounts paid by UTS to prosecute and maintain patents related to the licensed property.
The Melligen
Cell License Agreement requires that the Company pay royalty payments to UTS of (i) six percent gross exploitation revenue on
product sales; and (ii) twenty-five percent of gross revenues if the product is sub-licensed by the Company. In addition, the
Company is required to pay milestone payments of: (iii) AU$ 50,000 at the successful conclusion of clinical studies; (iv) AU$
100,000 at the successful conclusion of Phase 1 clinical trials; (v) AU$ 450,000 at the successful conclusion of Phase 2 clinical
trials; and (vi) AU$ 3,000,000 at the conclusion of Phase 3 clinical trials.
Cannabis
Licensing Agreement
Under the Cannabis
Licensing Agreement, the Company is required to pay Austrianova an Upfront Payment of $2,000,000. The Company has the right to
make periodic monthly partial payments of the Upfront Payment in amounts to be agreed upon between the parties prior to each such
payment being made. Under the Cannabis Licensing Agreement, the Upfront Payments must be paid in full by no later than June 30,
2015. As of the April 30, 2015, the Company has paid Austrianova $1 million of the Upfront Payment. The parties have agreed to
an amendment to the Cannabis Licensing Agreement pursuant to which the balance of the Upfront Payment will be due by December
31, 2015. That amendment is in the process of being documented.
The Cannabis
Licensing Agreement requires the Company to pay Austrianova, pursuant to a manufacturing agreement between the parties, a one-time
manufacturing setup fee in the amount of $800,000, of which 50% is required to be paid on the signing of a manufacturing agreement
for a product and 50% is required to be paid three months later. In addition, the Cannabis Licensing Agreement requires the Company
to pay a fee for producing the final encapsulated cell product of $800 per vial of 300 capsules after production with a minimum
purchased batch size of 400 vials of any Cell-in-a-Box® product.
The Cannabis
Licensing Agreement requires the Company to make future royalty and milestone payments as follows: (i) ten percent royalty of
the gross sale of all products sold by the Company; (ii) twenty percent royalty of the amount actually received by the Company
from sub-licensees on sub-licensees gross sales value; (iii) a milestone payment of $100,000 within 30 days of beginning
the first pre-clinical experiments using the encapsulated cells; (iv) a milestone payment of $500,000 within 30 days after enrollment
of the first human patient in the first clinical trial; (v) a milestone payment of $800,000 within 30 days after enrollment of
the first human patient in the first Phase 3 clinical trial; and (vi) a milestone payment of $1,000,000 due 90 days after having
a NDA or a BLA approved by the FDA or a MAA approved in Europe or its equivalent based on the country in which it is accepted
for each product.
Consulting
Agreement
We have
engaged ViruSure, a professional cell growing and adventitious agent testing company that has had extensive experience with the
CYP2B1-expressing cells that will be needed for our pancreatic cancer treatment. We did so in order to recover them from frozen
stocks of similar cells and regenerate new stocks for use by us in our preclinical studies and clinical trials. ViruSure is in
the process of cloning new cells from a selected clone. Those clones will be grown to populate a MCB and WCB for our future clinical
trials. There are approximately $195,000 in future milestone payments relating to testing to be completed.
Compensation
Agreements
The Company
entered into executive compensation agreements with its two executive officers and an employment agreement with one of its employees
in March 2015. Each agreement has a term of two years. The Company also entered into compensation agreements with two Board members
in April 2015 which continue in effect until the member is no longer on the Board.
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v3.3.1.900
13. INCOME TAXES
|
12 Months Ended |
Apr. 30, 2015 |
Income Tax Disclosure [Abstract] |
|
INCOME TAXES |
At April 30,
2015, the Company had federal and state net operating loss carryforwards of $33,257,000 and $33,257,000, respectively, available
to offset against future taxable income, which expire in 2019 through 2033.
Current tax laws
limit the amount of loss available to be offset against future taxable income when a substantial change in ownership occurs. Therefore,
the amount available to offset future taxable income may be limited. Based on the assessment of all available evidence including,
but not limited to, the Companys limited operating history in its core business and lack of profitability, uncertainties
of the commercial viability of its technology, the impact of government regulations and healthcare reform initiatives and other
risks normally associated with biotechnology companies, the Company has concluded that is more likely than not that these operating
loss carryforwards will not be realized. As a result, 100% of the deferred tax valuation allowance has been recorded against these
assets.
Deferred income
taxes reflect the net effect of temporary differences between the financial reporting carrying amounts of assets and liabilities
and income tax carrying amounts of assets and liabilities. The components of the Companys deferred tax assets and liabilities,
both current and long-term, are as follows:
| |
April 30, | |
| |
2015 | | |
2014 | |
Deferred tax assets: | |
| | | |
| | |
Net operating loss carryforwards | |
$ | 13,118,046 | | |
$ | 21,328,813 | |
Forgiveness of debt | |
| | | |
| 555,349 | |
Other | |
| 8,291 | | |
| | |
Total deferred tax assets | |
| 13,126,337 | | |
| 21,884,162 | |
Deferred tax liabilities: | |
| | | |
| | |
Shares issued for services | |
| | | |
| 5,701,048 | |
Conversion of preferred stock | |
| | | |
| 2,004,300 | |
Conversion of debt | |
| | | |
| 1,357,720 | |
Total deferred tax liabilities | |
| | | |
| 9,063,068 | |
Net deferred tax assets | |
| 13,126,337 | | |
| 12,821,094 | |
Valuation allowance | |
| (13,126,337 | ) | |
| (12,821,094 | ) |
| |
$ | | | |
$ | | |
For all years
presented, the Company did not recognize any deferred tax assets or liabilities. The net change in valuation allowance for the
years ended April 30, 2015 and 2014 were increases of $305,243 and $364,071, respectively.
The provision
for income taxes differs from the provision computed by applying the Federal statutory rate to net loss before income taxes as
follows:
| |
Years
ended April 30, | |
| |
2015 | | |
2014 | | |
2013 | |
Federal benefit at statutory rate | |
$ | (3,375,420 | ) | |
$ | (8,871,790 | ) | |
$ | (543,355 | ) |
State income taxes, net of Federal taxes | |
| (540,564 | ) | |
| (1,420,791 | ) | |
| (87,017 | ) |
Permanent differences | |
| 1,433,758 | | |
| 644,287 | | |
| 109,296 | |
Provision related to change in valuation allowance | |
| 305,243 | | |
| 364,071 | | |
| 256,694 | |
Return to provision | |
| 2,339,028 | | |
| 9,063,069 | | |
| 348,057 | |
Other, net | |
| (162,045 | ) | |
| 221,154 | | |
| (83,675 | ) |
| |
$ | | | |
$ | | | |
$ | | |
There have been
no changes to the Companys liability for unrecognized tax benefits during the year ended April 30, 2015.
The Company files
income tax return in the U.S. Federal jurisdiction and various state jurisdictions. As of the year ended April 30, 2015, the tax
returns for 2009 through 2014 remain open to examination by the Internal Revenue Service and various state tax authorities.
The Companys
policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense. As
of the years ended April 30, 2015, 2014 and 2013, the Company had accrued no interest or penalties related to uncertain tax positions.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.3.1.900
14. EARNINGS PER SHARE
|
12 Months Ended |
Apr. 30, 2015 |
Earnings Per Share [Abstract] |
|
EARNINGS PER SHARE |
Basic earnings
per share are based on the weighted average number of shares outstanding for a period. Diluted earnings per share are based upon
the weighted average number of shares and potentially dilutive common shares outstanding. Potential common shares outstanding
principally include stock options, under our stock plan and warrants. During April 30, 2015, 2014 and 2013, the Company incurred
losses. Accordingly, the effect of any common stock equivalent would be anti-dilutive during those periods and are not included
in the calculation of diluted weighted average number of shares outstanding.
The table
below sets forth the basic loss per share calculations:
| |
Years
Ended April 30, | |
| |
2015 | | |
2014 | | |
2013 | |
Net loss | |
$ | (9,927,706 | ) | |
$ | (27,254,020 | ) | |
$ | (1,598,102 | ) |
Basic weighted average number of shares outstanding | |
| 704,327,656 | | |
| 583,219,665 | | |
| 440,954,850 | |
Diluted weighted average number of shares
outstanding | |
| 704,327,656 | | |
| 583,219,665 | | |
| 440,954,850 | |
Basic and diluted loss per
share | |
$ | (0.01 | ) | |
$ | (0.05 | ) | |
$ | (0.00 | ) |
|
X |
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- DefinitionThe entire disclosure for earnings per share.
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v3.3.1.900
15. QUARTERLY FINANCIAL INFORMATION
|
12 Months Ended |
Apr. 30, 2015 |
Quarterly Financial Information Disclosure [Abstract] |
|
QUARTERLY FINANCIAL INFORMATION |
| |
| Quarter
Ended 31 July | | |
| Quarter
Ended 31 Oct | | |
| Quarter
Ended 31 Jan | | |
| Quarter
Ended 30 April | |
2015 | |
| | | |
| | | |
| | | |
| | |
Net revenue | |
$ | | | |
$ | | | |
$ | | | |
$ | | |
Cost of revenue | |
| | | |
| | | |
| | | |
| | |
Gross profit | |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| 1,583,160 | | |
| 6,200,845 | | |
| 1,456,554 | | |
| 4,020,176 | |
Other income (expenses), net | |
| (1,664 | ) | |
| 3,336,402 | | |
| (1,496 | ) | |
| (213 | ) |
Net loss | |
$ | (1,584,824 | ) | |
$ | (2,864,443 | ) | |
$ | (1,458,050 | ) | |
$ | (4,020,389 | ) |
Net loss per common share, Basic and Diluted | |
$ | (0.00 | ) | |
$ | (0.01 | ) | |
$ | (0.00 | ) | |
$ | (0.01 | ) |
| |
| Quarter
Ended 31 July | | |
| Quarter
Ended 31 Oct | | |
| Quarter
Ended 31 Jan | | |
| Quarter
Ended 30 April | |
2014 | |
| | | |
| | | |
| | | |
| | |
Net revenue | |
$ | | | |
$ | | | |
$ | | | |
$ | | |
Cost of revenue | |
| | | |
| | | |
| | | |
| | |
Gross profit | |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| 1,400,691 | | |
| 448,570 | | |
| 681,080 | | |
| 16,448,801 | |
Other income (expenses), net | |
| (3,265,676 | ) | |
| (5,209,500 | ) | |
| 222,308 | | |
| (22.010 | ) |
Net loss | |
$ | (4,666,367 | ) | |
$ | (5,658,070 | ) | |
$ | (458,772 | ) | |
$ | (16,470,811 | ) |
Net loss per common share, Basic and Diluted | |
$ | (0.01 | ) | |
$ | (0.01 | ) | |
$ | (0.00 | ) | |
$ | (0.03 | ) |
Quarterly and
year-to-date loss per share amounts are computed independently of each other. Therefore, the sum of the per share amounts for
the quarters may not agree to the per share amounts for the year.
|
X |
- DefinitionThe entire disclosure for the quarterly financial data in the annual financial statements. The disclosure may include a tabular presentation of financial information for each fiscal quarter for the current and previous year, including revenues, gross profit, income or loss before extraordinary items and earnings per share data. It also includes an indication if the information in the note is unaudited, comments on the aggregate effect of year-end adjustments, and an explanation of matters or transactions that affect comparability or are pertinent to an understanding of the information furnished.
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v3.3.1.900
16. SUBSEQUENT EVENTS
|
12 Months Ended |
Apr. 30, 2015 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
From May
1, 2015 to July 16, 2015, the Company issued 9,328,713 shares of common stock under the S-3 Registration Statement. The issuance
of the shares provided the Company approximately $1,220,000. The Company currently has $2,900,000 in cash as a result of the sales
of common stock under the S-3 Registration Statement.
On May 19,
2015, the Company made a payment of $300,000 to Austrianova pursuant to the Licensing Agreement that was entered into in December
2014.
|
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.3.1.900
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS
|
12 Months Ended |
Apr. 30, 2015 |
Valuation and Qualifying Accounts [Abstract] |
|
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS |
Description | |
| Balance
at Beginning
of Year | | |
| Additions
Charged to Costs
and Expenses | | |
| Charged
to Other Accounts | | |
| Deductions | | |
| Balance
at End
of Year | |
Reserve Deducted in the
Balance Sheets from the Asset to Which it Applies: | |
| | | |
| | | |
| | | |
| | | |
| | |
Allowance for Deferred Tax
Assets | |
| | | |
| | | |
| | | |
| | | |
| | |
Year ended April
30, 2015 | |
$ | 12,821,094 | | |
$ | | | |
$ | 305,243 | | |
$ | | | |
$ | 13,126,377 | |
Year ended April 30, 2014 | |
$ | 12,457,023 | | |
$ | | | |
$ | 364,071 | | |
$ | | | |
$ | 12,821,094 | |
Year ended April 30, 2013 | |
$ | 12,200,329 | | |
$ | | | |
$ | 256,694 | | |
$ | | | |
$ | 12,457,023 | |
|
X |
- DefinitionThe entire disclosure for any allowance and reserve accounts (their beginning and ending balances, as well as a reconciliation by type of activity during the period). Alternatively, disclosure of the required information may be within the footnotes to the financial statements or a supplemental schedule to the financial statements.
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v3.3.1.900
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
12 Months Ended |
Apr. 30, 2015 |
Accounting Policies [Abstract] |
|
Principles of Consolidation and Basis of Presentation |
Principles of Consolidation
and Basis of Presentation
The consolidated
financial statements include the accounts of the Company and its wholly owned subsidiaries. The Company operates independently
and through four wholly-owned subsidiaries: (i) Bio Blue Bird AG (Bio Blue Bird); (ii) Nuvilex Europe Limited (soon
to be renamed PharmaCyte Biotech Europe Limited); (iii) Nuvilex Australia Limited (soon to be renamed PharmaCyte Biotech Australia
Private Limited); and (iv) Viridis Biotech, Inc. (Viridis Biotech) and are prepared in accordance with United States
generally accepted accounting principles (U.S. GAAP) and the rules and regulations of the Securities and Exchange
Commission (Commission). Intercompany balances and transactions are eliminated. The Companys 14.5 % investment
in SG Austria is presented on the cost method of accounting.
|
Use of Estimates |
Use of Estimates
The preparation
of financial statements in accordance with U.S. GAAP requires the use of estimates and assumptions that affect the reported amounts
of assets and liabilities, disclosure of contingent assets and liabilities known to exist as of the date the financial statements
are published and the reported amounts of revenues and expenses during the reporting period. Uncertainties with respect to such
estimates and assumptions are inherent in the preparation of the Companys consolidated financial statements; accordingly,
it is possible that the actual results could differ from these estimates and assumptions, which could have a material effect on
the reported amounts of the Companys consolidated financial position and results of operations.
|
Goodwill and Intangible Assets |
Goodwill and Intangible Assets
The Company
records the excess of purchase price over the fair value of the identifiable net assets acquired as goodwill and other indefinite-lived
intangibles. The Financial Accounting Standards Board ("FASB") standard on goodwill and other intangible assets prescribes
a two-step process for impairment testing of goodwill and indefinite-lived intangibles, which is performed annually, as well as
when an event triggering impairment may have occurred. The first step tests for impairment, while the second step, if necessary,
measures the impairment. The Company has elected to perform its annual analysis at the end of its reporting year.
Impairment of Long-Lived Assets
The Company
evaluates long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an
asset may not be recoverable. If the estimated future cash flows (undiscounted and without interest charges) from the use of an
asset are less than carrying value, a write-down would be recorded to reduce the related asset to its estimated fair value. No
impairment was identified or recorded during the years ended April 30, 2015, 2014 and 2013.
|
Earnings per Share |
Earnings
per Share
Basic earnings
(loss) per share are computed by dividing earnings available to common stockholders by the weighted average number of outstanding
common shares during the period. Diluted earnings per share is computed by dividing net income by the weighted average number
of shares outstanding during the period increased to include the number of additional shares of common stock that would have been
outstanding if the potentially dilutive securities had been issued. During April 30, 2015, 2014 and 2013, the Company incurred
losses; therefore the effect of any common stock equivalent would be anti-dilutive during these periods.
|
Fair value of Financial Instruments |
Fair Value
of Financial Instruments
For certain
of the Companys non-derivative financial instruments, including cash, accounts payable and accrued expenses, the carrying
amount approximates fair value due to the short-term maturities of these instruments.
Accounting
Standards Codification ("ASC") Topic 820, Fair Value Measurements and Disclosures, requires disclosure
of the fair value of financial instruments held by the Company. ASC Topic 825, Financial Instruments, defines fair
value, and establishes a three-level valuation hierarchy for disclosures of fair value measurement that enhances disclosure requirements
for fair value measures. The carrying amounts reported in the consolidated balance sheets for receivables and current liabilities
each qualify as financial instruments and are a reasonable estimate of their fair values because of the short period of time between
the origination of such instruments and their expected realization and their current market rate of interest. The three levels
of valuation hierarchy are defined as follows:
|
· |
Level 1. Observable inputs such as quoted prices in active markets; |
|
· |
Level 2. Inputs, other than the quoted prices in active markets,
that are observable either directly or indirectly; and |
|
· |
Level 3. Unobservable inputs in which there is little or no market
data, which require the reporting entity to develop its own assumptions. |
The Company
adopted ASC subtopic 820-10, Fair Value Measurements and Disclosures ("ASC 820-10") and Accounting Standards Codification
subtopic 825-10, Financial Instruments ("ASC 825-10"), which permits entities to choose to measure many financial
instruments and certain other items at fair value. Neither of these statements had an impact on the Company's financial position,
results of operations or cash flows. The carrying value of cash, accounts payable and accrued expenses, as reflected in the balance
sheets, approximate fair value because of the short-term maturity of these instruments.
|
Derivative Instruments |
Derivative
Instruments
The Company
issued cashless warrants that are accounted for as a derivative instruments which prevents them from being considered indexed
to the Companys common stock and qualified for an exceptions to derivative accounting.
The Company
recognized the derivative instruments as either assets or liabilities on the accompanying consolidated balance sheets at fair
value. The Company records changes in the fair value (i.e. gains or losses) of the derivatives in the accompanying consolidated
statements of operations.
|
Revenue Recognition |
Revenue
Recognition
Sales of
products and related costs of products sold are recognized when: (i) persuasive evidence of an arrangement exists; (ii) delivery
has occurred; (iii) the price is fixed or determinable; and (iv) collectability is reasonably assured. These terms are typically
met upon the prepayment or invoicing and shipment of products.
|
Income Taxes |
Income Taxes
Deferred
taxes are calculated using the liability method whereby deferred tax assets are recognized for deductible temporary differences
and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences.
Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred
tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion
or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes
in tax laws and rates on the date of enactment.
A valuation
allowance is provided for deferred income tax assets when, in managements judgment, based upon currently available information
and other factors, it is more likely than not that all or a portion of such deferred income tax assets will not be realized. The
determination of the need for a valuation allowance is based on an on-going evaluation of current information including, among
other things, historical operating results, estimates of future earnings in different taxing jurisdictions and the expected timing
of the reversals of temporary differences. The Company believes the determination to record a valuation allowance to reduce a
deferred income tax asset is a significant accounting estimate because it is based, among other things, on an estimate of future
taxable income in the United States and certain other jurisdictions, which is susceptible to change and may or may not occur,
and because the impact of adjusting a valuation allowance may be material. In determining when to release the valuation allowance
established against our net deferred income tax assets, the Company considers all available evidence, both positive and negative.
Consistent with the Companys policy, and because of the Companys history of operating losses, the Company does not
currently recognize the benefit of all of our deferred tax assets, including tax loss carry forwards, that may be used to offset
future taxable income. The Company continually assesses its ability to generate sufficient taxable income during future periods
in which deferred tax assets may be realized. If and when the Company believes it is more likely than not that it will recover
its deferred tax assets, the Company will reverse the valuation allowance as an income tax benefit in the statements of operations.
The Company
accounts for its uncertain tax positions in accordance with U.S. GAAP. The purpose of this method is to clarify accounting for
uncertain tax positions recognized. The U.S. GAAP method of accounting for uncertain tax positions utilizes a two-step approach
to evaluate tax positions. Step one, recognition, requires evaluation of the tax position to determine if based solely on technical
merits it is more likely than not to be sustained upon examination. Step two, measurement, is addressed only if a position is
more likely than not to be sustained. In step two, the tax benefit is measured as the largest amount of benefit, determined on
a cumulative probability basis, which is more likely than not to be realized upon ultimate settlement with tax authorities. If
a position does not meet the more likely than not threshold for recognition in step one, no benefit is recorded until the first
subsequent period in which the more likely than not standard is met, the issue is resolved with the taxing authority or the statute
of limitations expires. Positions previously recognized are derecognized when the Company subsequently determines the position
no longer is more likely than not to be sustained. Evaluation of tax positions, their technical merits and measurements using
cumulative probability are highly subjective management estimates. Actual results could differ materially from these estimates.
|
Research and Development |
Research and Development
Research and
development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred.
Costs to acquire technologies, including licenses, that are utilized in research and development and that have no alternative
future use are expensed when incurred. Technology developed for use in our product candidates is expensed as incurred until technological
feasibility has been established.
Under the Cannabis
Licensing Agreement, the Company acquired from Austrianova an exclusive, world-wide license to use the Cell-in-a-Box®
trademark and its associated technology with genetically modified non-stem cell lines which are designed to activate cannabinoids
to develop therapies involving Cannabis.
Under the Cannabis
Licensing Agreement, the Company is required to pay Austrianova an Upfront Payment of $2,000,000. The Company has the right to
make periodic monthly partial payments of the Upfront Payment in amounts to be agreed upon between the parties prior to each such
payment being made. Under the Cannabis Licensing Agreement, the Upfront Payments must be paid in full by no later than June 30,
2015. As of April 30, 2015, the Company has paid Austrianova $1 million of the Upfront Payment. The parties have agreed to an
amendment to the Cannabis Licensing Agreement pursuant to which the balance of the Upfront Payment will be due by December 31,
2015. That amendment is in the process of being documented. The $2 million cost of the license has been recorded as research and
development costs.
|
Stock-Based Compensation |
Stock-Based Compensation
The Companys
stock-based employee compensation awards are described in Note 9. The Company has adopted the provisions of ASC 718, which requires
the fair value measurement and recognition of compensation expense for all stock-based awards made to directors, executives and
employees.
|
Concentration of Credit Risk |
Concentration of Credit Risk
The Company
has no significant off-balance-sheet concentrations of credit risk such as foreign exchange contracts, options contracts or other
foreign hedging arrangements. The Company maintains most of its cash balance at a financial institution located in California.
Accounts at this institution are insured by the Federal Deposit Insurance Corporation up to $250,000. Uninsured balances aggregated
approximately $2,450,000 at April 30, 2015. The Company has not experienced any losses in such accounts, and management believes
it is not exposed to any significant credit risk on cash.
|
Foreign Currency Translation |
Foreign
Currency Translation
The Company
translates the financial statements of its foreign subsidiary from the local (functional) currencies to US dollars in accordance
with FASB ASC 830, Foreign Currency Matters. All assets and liabilities of the Companys foreign subsidiaries are
translated at year-end exchange rates, while revenue and expenses are translated at average exchange rates prevailing during the
year. Adjustments for foreign currency translation fluctuations are excluded from net income and are included in other comprehensive
loss. Gains and losses on short-term intercompany foreign currency transactions are recognized as incurred.
|
Reclassifications |
Reclassification
Certain prior
year balances have been reclassified to conform to the 2015 presentation, with no changes in net loss for prior periods presented.
|
Recent accounting pronouncements |
Recent
Accounting Pronouncements
In May 2014,
the FASB issued ASU No. 2014-09 "Revenue from Contracts with Customers" (Topic 606). Topic 606 supersedes
the revenue recognition requirements in Topic 605, Revenue Recognition, including most industry-specific
revenue recognition guidance throughout the Industry Topics of the Codification. In addition, the amendments create a new
Subtopic 340-40, Other Assets and Deferred CostsContracts with Customers. In summary, the core principle
of Topic 606 is that an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount
that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. For a public
entity, the amendments in this Update are effective for annual reporting periods beginning after December 15, 2016, including
interim periods within that reporting period; early application is not permitted. The Company is currently evaluating the impact
this guidance will have on its consolidated financial position and consolidated statement of operations.
In June 2014,
the FASB issued ASU No. 2014-12, "Compensation - Stock Compensation (Topic 718)," which makes amendments to the
codification topic 718, "Accounting for Share-Based Payments," when the terms of an award provide that a performance
target could be achieved after the requisite service period. The new guidance becomes effective for annual reporting periods beginning
after December 15, 2015; early adoption is permitted. The Company is currently evaluating the impact this guidance will have on
its consolidated financial position and results of operations.
In August
2014, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2014-15,
Presentation of Financial Statements Going Concern, Subtopic 205-40, Disclosure of Uncertainties
about an Entitys Ability to Continue as a Going Concern. The amendments in this ASU apply to all entities
and require management to assess an entitys ability to continue as a going concern by incorporating and expanding upon
certain principles that are currently in U.S. auditing standards. Specifically, the amendments: (i) provide a definition of the
term substantial doubt; (ii) require an evaluation every reporting period including interim periods; (iii) provide
principles for considering the mitigating effect of managements plans; (iv) require certain disclosures when substantial
doubt is alleviated as a result of consideration of managements plans; (v) require an express statement and other
disclosures when substantial doubt is not alleviated; and (vi) require an assessment for a period of one year after the date that
the financial statements are issued or available to be issued. The amendments in this Update are effective for the annual period
ending after December 15, 2016. For annual periods and interim periods thereafter; early application is permitted. The Company
is currently evaluating the impact this guidance will have on its consolidated financial position and results of operations.
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v3.3.1.900
1A. RESTATEMENT OF PREVIOUSLY REPORTED FINANCIALS (Tables)
|
12 Months Ended |
Apr. 30, 2015 |
Restatement of Prior Year Income [Abstract] |
|
Restatement |
| |
April 30, 2015 | |
| |
As Previously Reported | | |
Adjustment | | |
As Restated | |
Selected Consolidated Balance Sheet Accounts | |
| | | |
| | | |
| | |
Prepaid expenses and other current
assets | |
$ | 119,257 | | |
$ | 1,349,024 | | |
$ | 1,468,281 | |
Total current assets | |
$ | 2,818,994 | | |
$ | 1,349,024 | | |
$ | 4,168,018 | |
Total assets | |
$ | 7,948,468 | | |
$ | 1,349,024 | | |
$ | 9,297,492 | |
Derivative liability | |
$ | 492,049 | | |
$ | (492,049 | ) | |
$ | | |
Total current liabilities | |
$ | 2,012,415 | | |
$ | (492,049 | ) | |
$ | 1,520,366 | |
Total liabilities | |
$ | 2,012,415 | | |
$ | (492,049 | ) | |
$ | 1,520,366 | |
Additional paid in capital | |
$ | 85,415,954 | | |
$ | 914,270 | | |
$ | 86,330,224 | |
Accumulated deficit | |
$ | (79,554,636 | ) | |
$ | 926,803 | | |
$ | (78,627,833 | ) |
Total stockholders' equity | |
$ | 5,936,053 | | |
$ | 1,841,073 | | |
$ | 7,777,126 | |
Total liabilities and stockholders' equity | |
$ | 7,948,468 | | |
$ | 1,349,024 | | |
$ | 9,297,492 | |
| |
Year Ended April
30, 2015 | |
| |
As Previously
Reported | | |
Adjustment | | |
As Restated | |
Consolidated Statement of Operation | |
| | | |
| | | |
| | |
Total revenue | |
$ | | | |
$ | | | |
$ | | |
Cost of revenue | |
| | | |
| | | |
| | |
Gross margin | |
| | | |
| | | |
| | |
Sales and marketing expense | |
| 230,500 | | |
| | | |
| 230,500 | |
Research and development costs | |
| 3,476,912 | | |
| | | |
| 3,476,912 | |
Compensation expense | |
| 6,489,334 | | |
| | | |
| 6,489,334 | |
Director fee | |
| 18,000 | | |
| | | |
| 18,000 | |
Legal and professional | |
| 884,346 | | |
| | | |
| 884,346 | |
General and administrative | |
| 2,596,397 | | |
| (434,754 | ) | |
| 2,161,643 | |
Loss from operations | |
| (13,695,489 | ) | |
| 434,754 | | |
| (13,260,735 | ) |
Unrealized loss on change
in derivative | |
| (492,049 | ) | |
| 492,049 | | |
| | |
Gain on settlements | |
| 3,337,967 | | |
| | | |
| 3,337,967 | |
Interest expense, net | |
| (4,938 | ) | |
| | | |
| (4,938 | ) |
Total other income (expense),
net | |
| 2,840,980 | | |
| 492,049 | | |
| 3,333,029 | |
Net loss | |
$ | (10,854,509 | ) | |
$ | 926,803 | | |
$ | (9,927,706 | ) |
| |
| | | |
| | | |
| | |
Basic and diluted loss
per share | |
$ | (0.02 | ) | |
$ | 0.01 | | |
$ | (0.01 | ) |
| |
Year Ended April
30, 2015 | |
| |
As Previously
Reported | | |
Adjustment | | |
As Restated | |
Consolidated Statement of Comprehensive Loss | |
| | | |
| | | |
| | |
Net loss | |
$ | (10,854,509 | ) | |
$ | 926,803 | | |
$ | (9,927,706 | ) |
Foreign currency translation
adjustment | |
| 1,462 | | |
| | | |
| 1,462 | |
Comprehensive loss | |
$ | (10,853,047 | ) | |
$ | 926,803 | | |
$ | (9,926,244 | ) |
| |
Year Ended April
30, 2015 | |
| |
As Previously Reported | | |
Adjustment | | |
As Restated | |
Consolidated Stockholders' Equity | |
| | | |
| | | |
| | |
Balance, April 30, 2014 | |
$ | 8,942,384 | | |
$ | | | |
$ | 8,942,384 | |
Shares issued for compensation | |
| 735,188 | | |
| | | |
| 735,188 | |
Shares issued for services | |
| 1,269,707 | | |
| | | |
| 1,269,707 | |
Shares issued for cash | |
| 3,719,832 | | |
| | | |
| 3,719,832 | |
Conversion of warrants | |
| 66,001 | | |
| | | |
| 66,001 | |
Recovery of shares issued for compensation | |
| (3,337,967 | ) | |
| | | |
| (3,337,967 | ) |
Recovery of shares issued for consulting expense | |
| (74,436 | ) | |
| | | |
| (74,436 | ) |
Stock options granted | |
| 5,236,901 | | |
| | | |
| 5,236,901 | |
Warrants granted | |
| 231,490 | | |
| 914,270 | | |
| 1,145,760 | |
Foreign currency translation adjustment | |
| 1,462 | | |
| | | |
| 1,462 | |
Net loss | |
| (10,854,509 | ) | |
| 926,803 | | |
| (9,927,706 | ) |
Balance, April 30, 2015 | |
$ | 5,936,053 | | |
$ | 1,841,073 | | |
$ | 7,777,126 | |
| |
Year Ended April
30, 2015 | |
| |
As Previously Reported | | |
Adjustment | | |
As Restated | |
Consolidated Statement of Cash Flows | |
| |
|
Operating activities | |
| | | |
| | | |
| | |
Net loss | |
$ | (10,854,509 | ) | |
$ | 926,803 | | |
$ | (9,927,706 | ) |
Stock issued for services | |
| 1,269,707 | | |
| (443,684 | ) | |
| 826,023 | |
Stock issued for compensation | |
| 735,189 | | |
| | | |
| 735,189 | |
Stock based compensation - options | |
| 5,236,901 | | |
| | | |
| 5,236,901 | |
Stock based compensation - warrants | |
| 231,490 | | |
| 8,930 | | |
| 240,420 | |
Gain on settlements | |
| (3,337,967 | ) | |
| | | |
| (3,337,967 | ) |
Gain on recovery of stock issued for services | |
| (74,436 | ) | |
| | | |
| (74,436 | ) |
Loss on derivative liability | |
| 492,049 | | |
| (492,049 | ) | |
| | |
Decrease in prepaid expenses and current assets | |
| 450,849 | | |
| | | |
| 450,849 | |
Increase in accounts payable | |
| 308,654 | | |
| | | |
| 308,654 | |
Decrease in accrued expenses | |
| (18,096 | ) | |
| | | |
| (18,096 | ) |
Increase in license agreement
obligation | |
| 1,000,000 | | |
| | | |
| 1,000,000 | |
Net cash used in operating
activities | |
| (4,560,169 | ) | |
| | | |
| (4,560,169 | ) |
| |
| | | |
| | | |
| | |
Investing activities | |
| | | |
| | | |
| | |
Net cash from investing
activities | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | |
Financing activities | |
| | | |
| | | |
| | |
Proceeds from sale of common stock | |
| 3,785,833 | | |
| | | |
| 3,785,833 | |
Repayment of debt, related
party | |
| (143,859 | ) | |
| | | |
| (143,859 | ) |
Net cash provided by financing
activities | |
| 3,641,974 | | |
| | | |
| 3,641,974 | |
| |
| | | |
| | | |
| | |
Effect of currency rate exchange on cash | |
| 1,462 | | |
| | | |
| 1,462 | |
| |
| | | |
| | | |
| | |
Net decrease in cash | |
| (916,733 | ) | |
| | | |
| (916,733 | ) |
Cash at beginning of year | |
| 3,616,470 | | |
| | | |
| 3,616,470 | |
Cash at end of year | |
$ | 2,699,737 | | |
$ | | | |
$ | 2,699,737 | |
|
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v3.3.1.900
9. STOCK OPTIONS AND WARRANTS (Tables)
|
12 Months Ended |
Apr. 30, 2015 |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] |
|
Assumptions |
| |
April 30, | |
| |
2015 | | |
2014 | | |
2013 | |
Risk-free interest rate | |
| 2 | % | |
| | | |
| | |
Expected volatility | |
| 145 | % | |
| | | |
| | |
Expected lives (years) | |
| 5 | | |
| | | |
| | |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % | |
| 0.00 | % |
|
Unvested employee stock option activity |
| |
| Options
Outstanding | | |
| Weighted
Average Grant Date Fair Value per Share | |
Nonvested, April 30, 2012 | |
| | | |
$ | | |
Granted | |
| | | |
| | |
Vested | |
| | | |
| | |
Forfeited | |
| | | |
| | |
Nonvested, April 30, 2013 | |
| | | |
| | |
Granted | |
| | | |
| | |
Vested | |
| | | |
| | |
Forfeited | |
| | | |
| | |
Nonvested, April 30, 2014 | |
| | | |
| | |
Granted | |
| 47,200,000 | | |
$ | 0.14 | |
Vested | |
| 40,600,000 | | |
| 0.15 | |
Forfeited | |
| | | |
| | |
Nonvested, April 30, 2015 | |
| 6,600,000 | | |
$ | 0.10 | |
|
Employee stock option activity |
| |
| Options
Outstanding | | |
| Weighted
Average Grant Date Fair Value per Share | |
Nonvested, April 30, 2012 | |
| | | |
$ | | |
Granted | |
| | | |
| | |
Vested | |
| | | |
| | |
Forfeited | |
| | | |
| | |
Nonvested, April 30, 2013 | |
| | | |
| | |
Granted | |
| | | |
| | |
Vested | |
| | | |
| | |
Forfeited | |
| | | |
| | |
Nonvested, April 30, 2014 | |
| | | |
| | |
Granted | |
| 5,250,000 | | |
$ | 0.19 | |
Vested | |
| 5,250,000 | | |
| 0.19 | |
Forfeited | |
| | | |
| | |
Nonvested, April 30, 2015 | |
| | | |
$ | | |
|
Range of outstanding stock options |
| |
Exercise Prices | |
Range of Exercise Price | |
$ | 0.19 | | |
$ | 0.11 | | |
$ | 0.18 | |
Number of Options | |
| 25,000,000 | | |
| 27,200,000 | | |
| 250,000 | |
Weighted Average Remaining Contractual Life (years) | |
| 4.42 | | |
| 4.67 | | |
| 4.98 | |
Weighted Average Stock Price | |
$ | 0.19 | | |
$ | 0.10 | | |
$ | 0.18 | |
Number of Options Exercisable | |
| 25,000,000 | | |
| 27,200,000 | | |
| 250,000 | |
Weighted Average Contractual Life (years) | |
| 5 | | |
| 5 | | |
| 5 | |
Weighted Average Exercise Price | |
$ | 0.19 | | |
$ | 0.10 | | |
$ | 0.18 | |
|
Warrant activity |
| |
| Warrants | | |
| Weighted
Average Price | | |
| Weighted
Average Fair Value | |
Outstanding, April 30, 2012 | |
| | | |
$ | | | |
$ | | |
Issued | |
| 59,433,600 | | |
| 0.125 | | |
| 0.064 | |
Exercised | |
| | | |
| | | |
| | |
Outstanding, April 30, 2013 | |
| 59,433,600 | | |
| 0.125 | | |
| 0.064 | |
Issued | |
| | | |
| | | |
| | |
Exercised | |
| (1,768,000 | ) | |
| | | |
| | |
Outstanding, April 30, 2014 | |
| 57,665,600 | | |
| 0.18 | | |
| 0.065 | |
Issued | |
| 15,854,308 | | |
| | | |
| | |
Exercised | |
| (550,000 | ) | |
| | | |
| | |
Outstanding, April 30, 2015 | |
| 72,969,908 | | |
| | | |
| | |
Exercisable, April 30, 2015 | |
| 72,969,908 | | |
$ | 0.17 | | |
$ | 0.075 | |
|
Schedule of warrants outstanding and exercisable |
Range of Exercise Prices | |
Number of Warrant
Shares Exercisable at 04/30/2015 | | |
Weighted Average
Remaining Contractual Life | | |
Exercisable Weighted
Average Exercise Price | |
$0.075, $0.11, $0.12, $0.18 and $0.25 | |
| 72,969,908 | | |
| 2.86 | | |
| 0.17 | |
| |
| | | |
| | | |
| | |
Five Year Term - $0.075 | |
| 1,056,000 | | |
| 2.45 | | |
| | |
Five Year Term - $0.12 | |
| 18,347,508 | | |
| 2.75 | | |
| | |
Five Year Term - $0.18 | |
| 19,811,200 | | |
| 2.67 | | |
| | |
Five Year Term - $0.25 | |
| 18,755,200 | | |
| 2.68 | | |
| | |
Five Year Term - $0.11 | |
| 10,000,000 | | |
| 4.90 | | |
| | |
Nine Month Term - $0.11 | |
| 5,000,000 | | |
| 0.67 | | |
| | |
| |
| 72,969,908 | | |
| | | |
| | |
|
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v3.3.1.900
13. INCOME TAXES (Tables)
|
12 Months Ended |
Apr. 30, 2015 |
Income Tax Disclosure [Abstract] |
|
Schedule of deferred tax assets |
| |
April 30, | |
| |
2015 | | |
2014 | |
Deferred tax assets: | |
| | | |
| | |
Net operating loss carryforwards | |
$ | 13,118,046 | | |
$ | 21,328,813 | |
Forgiveness of debt | |
| | | |
| 555,349 | |
Other | |
| 8,291 | | |
| | |
Total deferred tax assets | |
| 13,126,337 | | |
| 21,884,162 | |
Deferred tax liabilities: | |
| | | |
| | |
Shares issued for services | |
| | | |
| 5,701,048 | |
Conversion of preferred stock | |
| | | |
| 2,004,300 | |
Conversion of debt | |
| | | |
| 1,357,720 | |
Total deferred tax liabilities | |
| | | |
| 9,063,068 | |
Net deferred tax assets | |
| 13,126,337 | | |
| 12,821,094 | |
Valuation allowance | |
| (13,126,337 | ) | |
| (12,821,094 | ) |
| |
$ | | | |
$ | | |
|
Tax provision schedule |
| |
Years
ended April 30, | |
| |
2015 | | |
2014 | | |
2013 | |
Federal benefit at statutory rate | |
$ | (3,375,420 | ) | |
$ | (8,871,790 | ) | |
$ | (543,355 | ) |
State income taxes, net of Federal taxes | |
| (540,564 | ) | |
| (1,420,791 | ) | |
| (87,017 | ) |
Permanent differences | |
| 1,433,758 | | |
| 644,287 | | |
| 109,296 | |
Provision related to change in valuation allowance | |
| 305,243 | | |
| 364,071 | | |
| 256,694 | |
Return to provision | |
| 2,339,028 | | |
| 9,063,069 | | |
| 348,057 | |
Other, net | |
| (162,045 | ) | |
| 221,154 | | |
| (83,675 | ) |
| |
$ | | | |
$ | | | |
$ | | |
|
X |
- DefinitionTabular disclosure of the components of income tax expense attributable to continuing operations for each year presented including, but not limited to: current tax expense (benefit), deferred tax expense (benefit), investment tax credits, government grants, the benefits of operating loss carryforwards, tax expense that results from allocating certain tax benefits either directly to contributed capital or to reduce goodwill or other noncurrent intangible assets of an acquired entity, adjustments of a deferred tax liability or asset for enacted changes in tax laws or rates or a change in the tax status of the entity, and adjustments of the beginning-of-the-year balances of a valuation allowance because of a change in circumstances that causes a change in judgment about the realizability of the related deferred tax asset in future years.
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v3.3.1.900
14. EARNINGS PER SHARE (Tables)
|
12 Months Ended |
Apr. 30, 2015 |
Earnings Per Share [Abstract] |
|
Earnings per share calculations |
| |
Years
Ended April 30, | |
| |
2015 | | |
2014 | | |
2013 | |
Net loss | |
$ | (9,927,706 | ) | |
$ | (27,254,020 | ) | |
$ | (1,598,102 | ) |
Basic weighted average number of shares outstanding | |
| 704,327,656 | | |
| 583,219,665 | | |
| 440,954,850 | |
Diluted weighted average number of shares
outstanding | |
| 704,327,656 | | |
| 583,219,665 | | |
| 440,954,850 | |
Basic and diluted loss per
share | |
$ | (0.01 | ) | |
$ | (0.05 | ) | |
$ | (0.00 | ) |
|
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- DefinitionTabular disclosure of an entity's basic and diluted earnings per share calculations, including a reconciliation of numerators and denominators of the basic and diluted per-share computations for income from continuing operations.
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v3.3.1.900
15. QUARTERLY FINANCIAL INFORMATION (Tables)
|
12 Months Ended |
Apr. 30, 2015 |
Quarterly Financial Information Disclosure [Abstract] |
|
Quarterly financial information |
| |
| Quarter
Ended 31 July | | |
| Quarter
Ended 31 Oct | | |
| Quarter
Ended 31 Jan | | |
| Quarter
Ended 30 April | |
2015 | |
| | | |
| | | |
| | | |
| | |
Net revenue | |
$ | | | |
$ | | | |
$ | | | |
$ | | |
Cost of revenue | |
| | | |
| | | |
| | | |
| | |
Gross profit | |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| 1,583,160 | | |
| 6,200,845 | | |
| 1,456,554 | | |
| 4,020,176 | |
Other income (expenses), net | |
| (1,664 | ) | |
| 3,336,402 | | |
| (1,496 | ) | |
| (213 | ) |
Net loss | |
$ | (1,584,824 | ) | |
$ | (2,864,443 | ) | |
$ | (1,458,050 | ) | |
$ | (4,020,389 | ) |
Net loss per common share, Basic and Diluted | |
$ | (0.00 | ) | |
$ | (0.01 | ) | |
$ | (0.00 | ) | |
$ | (0.01 | ) |
| |
| Quarter
Ended 31 July | | |
| Quarter
Ended 31 Oct | | |
| Quarter
Ended 31 Jan | | |
| Quarter
Ended 30 April | |
2014 | |
| | | |
| | | |
| | | |
| | |
Net revenue | |
$ | | | |
$ | | | |
$ | | | |
$ | | |
Cost of revenue | |
| | | |
| | | |
| | | |
| | |
Gross profit | |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| 1,400,691 | | |
| 448,570 | | |
| 681,080 | | |
| 16,448,801 | |
Other income (expenses), net | |
| (3,265,676 | ) | |
| (5,209,500 | ) | |
| 222,308 | | |
| (22.010 | ) |
Net loss | |
$ | (4,666,367 | ) | |
$ | (5,658,070 | ) | |
$ | (458,772 | ) | |
$ | (16,470,811 | ) |
Net loss per common share, Basic and Diluted | |
$ | (0.01 | ) | |
$ | (0.01 | ) | |
$ | (0.00 | ) | |
$ | (0.03 | ) |
|
X |
- DefinitionTabular disclosure of the quarterly financial data in the annual financial statements. The disclosure includes financial information for each fiscal quarter for the current and previous year, including revenues, gross profit, income (loss) before extraordinary items and cumulative effect of a change in accounting principle and earnings per share data.
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v3.3.1.900
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS (Tables)
|
12 Months Ended |
Apr. 30, 2015 |
Valuation and Qualifying Accounts [Abstract] |
|
Schedule of valuation and qualifying accounts |
Description | |
| Balance
at Beginning
of Year | | |
| Additions
Charged to Costs
and Expenses | | |
| Charged
to Other Accounts | | |
| Deductions | | |
| Balance
at End
of Year | |
Reserve Deducted in the
Balance Sheets from the Asset to Which it Applies: | |
| | | |
| | | |
| | | |
| | | |
| | |
Allowance for Deferred Tax
Assets | |
| | | |
| | | |
| | | |
| | | |
| | |
Year ended April
30, 2015 | |
$ | 12,821,094 | | |
$ | | | |
$ | 305,243 | | |
$ | | | |
$ | 13,126,377 | |
Year ended April 30, 2014 | |
$ | 12,457,023 | | |
$ | | | |
$ | 364,071 | | |
$ | | | |
$ | 12,821,094 | |
Year ended April 30, 2013 | |
$ | 12,200,329 | | |
$ | | | |
$ | 256,694 | | |
$ | | | |
$ | 12,457,023 | |
|
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v3.3.1.900
1A. RESTATEMENT OF PREVIOUSLY REPORTED INFORMATION (Details - Balance Sheet) - USD ($)
|
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Apr. 30, 2012 |
Prepaid expenses and other current assets |
$ 1,468,281
|
$ 570,106
|
|
|
Total current assets |
4,168,018
|
4,186,576
|
|
|
Total assets |
9,297,492
|
9,316,050
|
|
|
Derivative liability |
0
|
|
|
|
Total current liabilities |
1,520,366
|
373,666
|
|
|
Total liabilities |
1,520,366
|
373,666
|
|
|
Additional paid in capital |
86,330,224
|
75,998,588
|
|
|
Accumulated deficit |
(78,627,833)
|
(68,700,127)
|
|
|
Total stockholders' equity |
7,777,126
|
8,942,384
|
$ (1,501,456)
|
$ (2,279,850)
|
Total liabilities and stockholders' equity |
9,297,492
|
9,316,050
|
|
|
Scenario, Previously Reported [Member] |
|
|
|
|
Prepaid expenses and other current assets |
119,257
|
|
|
|
Total current assets |
2,818,994
|
|
|
|
Total assets |
7,948,468
|
|
|
|
Derivative liability |
492,049
|
|
|
|
Total current liabilities |
2,012,415
|
|
|
|
Total liabilities |
2,012,415
|
|
|
|
Additional paid in capital |
85,415,954
|
|
|
|
Accumulated deficit |
(79,554,636)
|
|
|
|
Total stockholders' equity |
5,936,053
|
$ 8,942,384
|
|
|
Total liabilities and stockholders' equity |
7,948,468
|
|
|
|
Scenario, Adjustment [Member] |
|
|
|
|
Prepaid expenses and other current assets |
1,349,024
|
|
|
|
Total current assets |
1,349,024
|
|
|
|
Total assets |
1,349,024
|
|
|
|
Derivative liability |
(492,049)
|
|
|
|
Total current liabilities |
(492,049)
|
|
|
|
Total liabilities |
(492,049)
|
|
|
|
Additional paid in capital |
914,270
|
|
|
|
Accumulated deficit |
926,803
|
|
|
|
Total stockholders' equity |
1,841,073
|
|
|
|
Total liabilities and stockholders' equity |
$ 1,349,024
|
|
|
|
X |
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v3.3.1.900
1A. RESTATEMENT OF PREVIOUSLY REPORTED INFORMATION (Details - Statement of Operations/Comprehensive loss) - USD ($)
|
3 Months Ended |
12 Months Ended |
Apr. 30, 2015 |
Jan. 31, 2015 |
Oct. 31, 2014 |
Jul. 31, 2014 |
Apr. 30, 2014 |
Jan. 31, 2014 |
Oct. 31, 2013 |
Jul. 31, 2013 |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Consolidated Statement of Operations |
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 12,160
|
Cost of revenue |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9,620
|
Gross margin |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2,540
|
Sales and marketing expense |
|
|
|
|
|
|
|
|
230,500
|
872,200
|
106,413
|
Research and development costs |
|
|
|
|
|
|
|
|
3,476,912
|
323,500
|
0
|
Compensation expense |
|
|
|
|
|
|
|
|
6,489,334
|
13,609,995
|
678,707
|
Director fee |
|
|
|
|
|
|
|
|
18,000
|
768,000
|
0
|
Legal and professional |
|
|
|
|
|
|
|
|
884,346
|
1,487,668
|
284,510
|
General and administrative |
|
|
|
|
|
|
|
|
2,161,643
|
1,917,779
|
617,271
|
Loss from operations |
|
|
|
|
|
|
|
|
(13,260,735)
|
(18,979,142)
|
(1,684,361)
|
Unrealized loss on change in derivative |
|
|
|
|
|
|
|
|
0
|
|
|
Gain on settlements |
|
|
|
|
|
|
|
|
3,337,967
|
0
|
0
|
Interest expense, net |
|
|
|
|
|
|
|
|
(4,938)
|
(19,963)
|
(154,416)
|
Total other income (expense), net |
(213)
|
(1,496)
|
3,336,402
|
(1,664)
|
(22,010)
|
222,308
|
(5,209,500)
|
(3,265,676)
|
3,333,029
|
(8,274,878)
|
86,259
|
Net loss |
$ (4,020,389)
|
$ (1,458,050)
|
$ (2,864,443)
|
$ (1,584,824)
|
$ (16,470,811)
|
$ (458,772)
|
$ (5,658,070)
|
$ (4,666,367)
|
$ (9,927,706)
|
$ (27,254,020)
|
$ (1,598,102)
|
Basic and diluted loss per share |
$ (.01)
|
$ (0.00)
|
$ (0.01)
|
$ (0.00)
|
$ (.03)
|
$ 0.00
|
$ (.01)
|
$ (.01)
|
$ (.01)
|
$ (0.05)
|
$ 0.00
|
Consolidated Statement of Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ (4,020,389)
|
$ (1,458,050)
|
$ (2,864,443)
|
$ (1,584,824)
|
$ (16,470,811)
|
$ (458,772)
|
$ (5,658,070)
|
$ (4,666,367)
|
$ (9,927,706)
|
$ (27,254,020)
|
$ (1,598,102)
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
1,462
|
0
|
0
|
Comprehensive loss |
|
|
|
|
|
|
|
|
(9,926,244)
|
$ (27,254,020)
|
$ (1,598,102)
|
Scenario, Previously Reported [Member] |
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statement of Operations |
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
|
|
|
|
|
|
0
|
|
|
Cost of revenue |
|
|
|
|
|
|
|
|
0
|
|
|
Gross margin |
|
|
|
|
|
|
|
|
0
|
|
|
Sales and marketing expense |
|
|
|
|
|
|
|
|
230,500
|
|
|
Research and development costs |
|
|
|
|
|
|
|
|
3,476,912
|
|
|
Compensation expense |
|
|
|
|
|
|
|
|
6,489,334
|
|
|
Director fee |
|
|
|
|
|
|
|
|
18,000
|
|
|
Legal and professional |
|
|
|
|
|
|
|
|
884,346
|
|
|
General and administrative |
|
|
|
|
|
|
|
|
2,596,397
|
|
|
Loss from operations |
|
|
|
|
|
|
|
|
(13,695,489)
|
|
|
Unrealized loss on change in derivative |
|
|
|
|
|
|
|
|
(492,049)
|
|
|
Gain on settlements |
|
|
|
|
|
|
|
|
3,337,967
|
|
|
Interest expense, net |
|
|
|
|
|
|
|
|
(4,938)
|
|
|
Total other income (expense), net |
|
|
|
|
|
|
|
|
2,840,980
|
|
|
Net loss |
|
|
|
|
|
|
|
|
$ (10,854,509)
|
|
|
Basic and diluted loss per share |
|
|
|
|
|
|
|
|
$ (.02)
|
|
|
Consolidated Statement of Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
$ (10,854,509)
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
1,462
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
(10,853,047)
|
|
|
Scenario, Adjustment [Member] |
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statement of Operations |
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
|
|
|
|
|
|
0
|
|
|
Cost of revenue |
|
|
|
|
|
|
|
|
0
|
|
|
Gross margin |
|
|
|
|
|
|
|
|
0
|
|
|
Sales and marketing expense |
|
|
|
|
|
|
|
|
0
|
|
|
Research and development costs |
|
|
|
|
|
|
|
|
0
|
|
|
Compensation expense |
|
|
|
|
|
|
|
|
0
|
|
|
Director fee |
|
|
|
|
|
|
|
|
0
|
|
|
Legal and professional |
|
|
|
|
|
|
|
|
0
|
|
|
General and administrative |
|
|
|
|
|
|
|
|
(434,754)
|
|
|
Loss from operations |
|
|
|
|
|
|
|
|
434,754
|
|
|
Unrealized loss on change in derivative |
|
|
|
|
|
|
|
|
492,049
|
|
|
Gain on settlements |
|
|
|
|
|
|
|
|
0
|
|
|
Interest expense, net |
|
|
|
|
|
|
|
|
0
|
|
|
Total other income (expense), net |
|
|
|
|
|
|
|
|
492,049
|
|
|
Net loss |
|
|
|
|
|
|
|
|
$ 926,803
|
|
|
Basic and diluted loss per share |
|
|
|
|
|
|
|
|
$ 0.01
|
|
|
Consolidated Statement of Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
$ 926,803
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
0
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
$ 926,803
|
|
|
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v3.3.1.900
1A. RESTATEMENT OF PREVIOUSLY REPORTED INFORMATION (Details - Stockholders Equity) - USD ($)
|
3 Months Ended |
12 Months Ended |
Apr. 30, 2015 |
Jan. 31, 2015 |
Oct. 31, 2014 |
Jul. 31, 2014 |
Apr. 30, 2014 |
Jan. 31, 2014 |
Oct. 31, 2013 |
Jul. 31, 2013 |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Consolidated Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
Beginning balance, amount |
|
|
|
$ 8,942,384
|
|
|
|
$ (1,501,456)
|
$ 8,942,384
|
$ (1,501,456)
|
$ (2,279,850)
|
Shares issued for compensation |
|
|
|
|
|
|
|
|
735,188
|
13,333,788
|
653,696
|
Shares issued for services |
|
|
|
|
|
|
|
|
1,269,707
|
3,826,521
|
331,000
|
Shares issued for cash |
|
|
|
|
|
|
|
|
3,719,832
|
6,918,000
|
10,000
|
Conversion of warrants |
|
|
|
|
|
|
|
|
66,001
|
1,592,880
|
|
Recovery of shares issued for compensation |
|
|
|
|
|
|
|
|
(3,337,967)
|
|
|
Recovery of shares issued for consulting expense |
|
|
|
|
|
|
|
|
(74,436)
|
|
|
Stock options granted |
|
|
|
|
|
|
|
|
5,236,901
|
|
|
Warrants granted |
|
|
|
|
|
|
|
|
1,145,760
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
1,462
|
0
|
0
|
Net loss |
$ (4,020,389)
|
$ (1,458,050)
|
$ (2,864,443)
|
(1,584,824)
|
$ (16,470,811)
|
$ (458,772)
|
$ (5,658,070)
|
$ (4,666,367)
|
(9,927,706)
|
(27,254,020)
|
(1,598,102)
|
Ending balance, amount |
7,777,126
|
|
|
|
8,942,384
|
|
|
|
7,777,126
|
8,942,384
|
$ (1,501,456)
|
Scenario, Previously Reported [Member] |
|
|
|
|
|
|
|
|
|
|
|
Consolidated Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
Beginning balance, amount |
|
|
|
$ 8,942,384
|
|
|
|
|
8,942,384
|
|
|
Shares issued for compensation |
|
|
|
|
|
|
|
|
735,188
|
|
|
Shares issued for services |
|
|
|
|
|
|
|
|
1,269,707
|
|
|
Shares issued for cash |
|
|
|
|
|
|
|
|
3,719,832
|
|
|
Conversion of warrants |
|
|
|
|
|
|
|
|
66,001
|
|
|
Recovery of shares issued for compensation |
|
|
|
|
|
|
|
|
(3,337,967)
|
|
|
Recovery of shares issued for consulting expense |
|
|
|
|
|
|
|
|
(74,436)
|
|
|
Stock options granted |
|
|
|
|
|
|
|
|
5,236,901
|
|
|
Warrants granted |
|
|
|
|
|
|
|
|
231,490
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
1,462
|
|
|
Net loss |
|
|
|
|
|
|
|
|
(10,854,509)
|
|
|
Ending balance, amount |
5,936,053
|
|
|
|
$ 8,942,384
|
|
|
|
5,936,053
|
$ 8,942,384
|
|
Scenario, Adjustment [Member] |
|
|
|
|
|
|
|
|
|
|
|
Consolidated Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
Warrants granted |
|
|
|
|
|
|
|
|
914,270
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
0
|
|
|
Net loss |
|
|
|
|
|
|
|
|
926,803
|
|
|
Ending balance, amount |
$ 1,841,073
|
|
|
|
|
|
|
|
$ 1,841,073
|
|
|
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v3.3.1.900
1A. RESTATEMENT OF PREVIOUSLY REPORTED INFORMATION (Details - Statement of Cash Flows) - USD ($)
|
3 Months Ended |
12 Months Ended |
Apr. 30, 2015 |
Jan. 31, 2015 |
Oct. 31, 2014 |
Jul. 31, 2014 |
Apr. 30, 2014 |
Jan. 31, 2014 |
Oct. 31, 2013 |
Jul. 31, 2013 |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Operating activities |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ (4,020,389)
|
$ (1,458,050)
|
$ (2,864,443)
|
$ (1,584,824)
|
$ (16,470,811)
|
$ (458,772)
|
$ (5,658,070)
|
$ (4,666,367)
|
$ (9,927,706)
|
$ (27,254,020)
|
$ (1,598,102)
|
Stock issued for services |
|
|
|
|
|
|
|
|
826,023
|
17,928,309
|
984,696
|
Stock issued for compensation |
|
|
|
|
|
|
|
|
735,189
|
0
|
0
|
Stock based compensation - options |
|
|
|
|
|
|
|
|
5,236,901
|
0
|
0
|
Stock based compensation - warrants |
|
|
|
|
|
|
|
|
240,420
|
0
|
0
|
Gain on settlements |
|
|
|
|
|
|
|
|
(3,337,967)
|
0
|
0
|
Gain on recovery of stock issued for services |
|
|
|
|
|
|
|
|
(74,436)
|
0
|
0
|
Loss on derivative liability |
|
|
|
|
|
|
|
|
0
|
|
|
Decrease in prepaid expenses and current assets |
|
|
|
|
|
|
|
|
(450,849)
|
442,236
|
(62,667)
|
Increase in accounts payable |
|
|
|
|
|
|
|
|
308,654
|
(59,191)
|
97,708
|
Decrease in accrued expenses |
|
|
|
|
|
|
|
|
(18,096)
|
17,515
|
194,755
|
Increase in license agreement obligation |
|
|
|
|
|
|
|
|
1,000,000
|
0
|
0
|
Net cash used in operating activities |
|
|
|
|
|
|
|
|
(4,560,169)
|
(1,554,708)
|
(390,426)
|
Investing activities |
|
|
|
|
|
|
|
|
|
|
|
Net cash from investing activities |
|
|
|
|
|
|
|
|
0
|
(3,559,069)
|
(646,750)
|
Financing activities |
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of common stock |
|
|
|
|
|
|
|
|
3,785,833
|
8,510,880
|
1,146,000
|
Repayment of debt, related party |
|
|
|
|
|
|
|
|
(143,859)
|
(61,522)
|
(75,000)
|
Net cash provided by financing activities |
|
|
|
|
|
|
|
|
3,641,974
|
8,530,944
|
1,220,756
|
Effect of currency rate exchange on cash |
|
|
|
|
|
|
|
|
1,462
|
0
|
0
|
Net decrease in cash |
|
|
|
|
|
|
|
|
(916,733)
|
3,417,167
|
183,580
|
Cash at beginning of the year |
|
|
|
3,616,470
|
|
|
|
$ 199,303
|
3,616,470
|
199,303
|
15,723
|
Cash at end of the year |
2,699,737
|
|
|
|
3,616,470
|
|
|
|
2,699,737
|
3,616,470
|
$ 199,303
|
Scenario, Previously Reported [Member] |
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
(10,854,509)
|
|
|
Stock issued for services |
|
|
|
|
|
|
|
|
1,269,707
|
|
|
Stock issued for compensation |
|
|
|
|
|
|
|
|
735,189
|
|
|
Stock based compensation - options |
|
|
|
|
|
|
|
|
5,236,901
|
|
|
Stock based compensation - warrants |
|
|
|
|
|
|
|
|
231,490
|
|
|
Gain on settlements |
|
|
|
|
|
|
|
|
(3,337,967)
|
|
|
Gain on recovery of stock issued for services |
|
|
|
|
|
|
|
|
(74,436)
|
|
|
Loss on derivative liability |
|
|
|
|
|
|
|
|
492,049
|
|
|
Decrease in prepaid expenses and current assets |
|
|
|
|
|
|
|
|
450,849
|
|
|
Increase in accounts payable |
|
|
|
|
|
|
|
|
308,654
|
|
|
Decrease in accrued expenses |
|
|
|
|
|
|
|
|
(18,096)
|
|
|
Increase in license agreement obligation |
|
|
|
|
|
|
|
|
1,000,000
|
|
|
Net cash used in operating activities |
|
|
|
|
|
|
|
|
(4,560,169)
|
|
|
Investing activities |
|
|
|
|
|
|
|
|
|
|
|
Net cash from investing activities |
|
|
|
|
|
|
|
|
0
|
|
|
Financing activities |
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of common stock |
|
|
|
|
|
|
|
|
3,785,833
|
|
|
Repayment of debt, related party |
|
|
|
|
|
|
|
|
(143,859)
|
|
|
Net cash provided by financing activities |
|
|
|
|
|
|
|
|
3,641,974
|
|
|
Effect of currency rate exchange on cash |
|
|
|
|
|
|
|
|
1,462
|
|
|
Net decrease in cash |
|
|
|
|
|
|
|
|
(916,733)
|
|
|
Cash at beginning of the year |
|
|
|
$ 3,616,470
|
|
|
|
|
3,616,470
|
|
|
Cash at end of the year |
$ 2,699,737
|
|
|
|
$ 3,616,470
|
|
|
|
2,699,737
|
$ 3,616,470
|
|
Scenario, Adjustment [Member] |
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
926,803
|
|
|
Stock issued for services |
|
|
|
|
|
|
|
|
(443,684)
|
|
|
Stock based compensation - warrants |
|
|
|
|
|
|
|
|
8,930
|
|
|
Gain on settlements |
|
|
|
|
|
|
|
|
0
|
|
|
Loss on derivative liability |
|
|
|
|
|
|
|
|
$ (492,049)
|
|
|
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v3.3.1.900
2. CAPITALIZATION AND MANAGEMENT PLANS (Details Narrative) - USD ($)
|
3 Months Ended |
12 Months Ended |
Apr. 30, 2015 |
Jan. 31, 2015 |
Oct. 31, 2014 |
Jul. 31, 2014 |
Apr. 30, 2014 |
Jan. 31, 2014 |
Oct. 31, 2013 |
Jul. 31, 2013 |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Capitalization And Management Plans |
|
|
|
|
|
|
|
|
|
|
|
Accumulated deficit |
$ (78,627,833)
|
|
|
|
$ (68,700,127)
|
|
|
|
$ (78,627,833)
|
$ (68,700,127)
|
|
Net loss |
$ (4,020,389)
|
$ (1,458,050)
|
$ (2,864,443)
|
$ (1,584,824)
|
$ (16,470,811)
|
$ (458,772)
|
$ (5,658,070)
|
$ (4,666,367)
|
$ (9,927,706)
|
$ (27,254,020)
|
$ (1,598,102)
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4. BUSINESS ACQUISITION (Details Narrative) - USD ($)
|
Apr. 30, 2015 |
Apr. 30, 2014 |
Licenses |
$ 3,549,427
|
$ 3,549,427
|
Cell-in-a-Box |
|
|
Licenses |
$ 1,549,427
|
|
X |
- DefinitionCarrying amount (original costs adjusted for previously recognized amortization and impairment) as of the balance sheet date for the capitalized costs to acquire rights under a license arrangement (for example, to sell specified products in a specified territory) having an indefinite period of benefit.
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- DefinitionCarrying value as of the balance sheet date of obligations incurred and payable, which are not elsewhere specified in the taxonomy. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer).
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6. DEBT (Details Narrative) - USD ($)
|
12 Months Ended |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Gain (loss) on settlement of debt |
$ 0
|
$ (3,993,295)
|
$ (39,000)
|
Payment toward license |
0
|
3,500,000
|
$ 646,750
|
License payable |
$ 1,000,000
|
$ 0
|
|
Licensing fees |
|
|
|
Common stock issued to pay licensing fees, shares issued |
|
2,000,000
|
|
Common stock issued to pay licensing fees, value |
|
$ 226,000
|
|
Gain (loss) on settlement of debt |
|
$ 174,000
|
|
Note holder |
|
|
|
Common stock issued to pay licensing fees, shares issued |
|
250,000
|
|
Common stock issued to pay licensing fees, value |
|
$ 45,500
|
|
Gain (loss) on settlement of debt |
|
$ (19,500)
|
|
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- DefinitionCommon stock issued to pay licensing fees, shares issued
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v3.3.1.900
9. STOCK OPTIONS AND WARRANTS (Details - Unvested stock options) - $ / shares
|
12 Months Ended |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Unvested Stock Options [Member] |
|
|
|
Options Outstanding |
|
|
|
Beginning balance |
|
|
|
Granted |
47,200,000
|
|
|
Vested |
40,600,000
|
|
|
Forfeited |
|
|
|
Ending balance |
6,600,000
|
|
|
Weighted Average Grant Date Fair Value Per Share |
|
|
|
Beginning balance |
|
|
|
Granted |
$ 0.14
|
|
|
Vested |
$ 0.15
|
|
|
Forfeited |
|
|
|
Ending balance |
$ 0.10
|
|
|
Options [Member] |
|
|
|
Options Outstanding |
|
|
|
Beginning balance |
|
|
|
Granted |
5,250,000
|
|
|
Vested |
5,250,000
|
|
|
Forfeited |
|
|
|
Ending balance |
0
|
|
|
Weighted Average Grant Date Fair Value Per Share |
|
|
|
Beginning balance |
|
|
|
Granted |
$ 0.19
|
|
|
Vested |
$ 0.19
|
|
|
Forfeited |
|
|
|
Ending balance |
$ 0.00
|
|
|
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- DefinitionShare-based Compensation Arrangements by Share-based Payment Award, Options, Vested in Period, Weighted Average Exercise Price
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v3.3.1.900
9. STOCK OPTIONS AND WARRANTS (Details - Options information)
|
12 Months Ended |
Apr. 30, 2015
$ / shares
shares
|
$0.19 |
|
Number of Options | shares |
25,000,000
|
Weighted Average Remaining Contractual LIfe (years) |
4 years 5 months 1 day
|
Weighted Average Stock Price | $ / shares |
$ 0.19
|
Numer of Options Exercisable | shares |
25,000,000
|
Weighted Average Contractual Life (years) |
5 years
|
Weighted Average Exercise Price | $ / shares |
$ 0.19
|
$0.11 |
|
Number of Options | shares |
27,200,000
|
Weighted Average Remaining Contractual LIfe (years) |
4 years 8 months 1 day
|
Weighted Average Stock Price | $ / shares |
$ .010
|
Numer of Options Exercisable | shares |
27,200,000
|
Weighted Average Contractual Life (years) |
5 years
|
Weighted Average Exercise Price | $ / shares |
$ 0.10
|
$0.18 |
|
Number of Options | shares |
250,000
|
Weighted Average Remaining Contractual LIfe (years) |
4 years 11 months 23 days
|
Weighted Average Stock Price | $ / shares |
$ 0.18
|
Numer of Options Exercisable | shares |
250,000
|
Weighted Average Contractual Life (years) |
5 years
|
Weighted Average Exercise Price | $ / shares |
$ 0.18
|
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v3.3.1.900
9. STOCK OPTIONS AND WARRANTS (Details - Warrant activity) - Warrants - $ / shares
|
12 Months Ended |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Warrants outstanding, beginning balance |
57,665,600
|
59,433,600
|
0
|
Warrants issued |
15,854,308
|
0
|
59,433,600
|
Warrants exercised |
(550,000)
|
(1,768,000)
|
0
|
Warrants outstanding, ending balance |
72,969,908
|
57,665,600
|
59,433,600
|
Warrants exercisable |
|
72,969,908
|
|
Weighted average exercise price warrants outstanding, beginning balance |
$ 0.18
|
$ 0.125
|
$ 0
|
Weighted average exercise price warrants issued |
|
|
0.125
|
Weighted average exercise price warrants outstanding, ending balance |
0.17
|
0.18
|
0.125
|
Weighted average fair value per share warrants outstanding, beginning balance |
0.065
|
0.064
|
|
Weighted average fair value warrants issued |
|
|
0.064
|
Weighted average fair value per share warrants outstanding, ending balance |
$ 0.075
|
$ 0.065
|
$ 0.064
|
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v3.3.1.900
9. STOCK OPTIONS AND WARRANTS (Details - Warrant information)
|
12 Months Ended |
Apr. 30, 2015
$ / shares
shares
|
$0.075, $0.11, $0.12, $0.18 and $0.25 |
|
Number of Warrants exercisable |
72,969,908
|
Weighted average remaining contractual term |
2 years 10 months 10 days
|
Weighted average exercise price exercisable | $ / shares |
$ 0.17
|
Five Year Term $0.075 |
|
Number of Warrants exercisable |
1,056,000
|
Weighted average remaining contractual term |
2 years 5 months 12 days
|
Five Year Term $0.12 |
|
Number of Warrants exercisable |
18,347,508
|
Weighted average remaining contractual term |
2 years 9 months
|
Five Year Term $0.18 |
|
Number of Warrants exercisable |
19,811,200
|
Weighted average remaining contractual term |
2 years 8 months 1 day
|
Five Year Term $0.25 |
|
Number of Warrants exercisable |
18,755,200
|
Weighted average remaining contractual term |
2 years 8 months 5 days
|
Five Year Term $0.11 |
|
Number of Warrants exercisable |
10,000,000
|
Weighted average remaining contractual term |
4 years 10 months 24 days
|
Nine Year Term $0.11 |
|
Number of Warrants exercisable |
5,000,000
|
Weighted average remaining contractual term |
8 months 1 day
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v3.3.1.900
11. RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)
|
12 Months Ended |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Payments made to related party |
$ 143,859
|
$ 61,522
|
$ 75,000
|
Professional fees |
884,346
|
1,487,668
|
284,510
|
Berkshire Capital |
|
|
|
Due to related party |
0
|
$ 0
|
393,158
|
Stock issued in settlement of debt, shares issued |
|
26,000,000
|
|
Stock issued in settlement of debt, principal |
|
$ 471,011
|
|
Stock issued in settlement of debt, interest |
|
30,195
|
|
Gruden [Member] |
|
|
|
Due to related party |
0
|
0
|
23,200
|
Payments made to related party |
|
23,200
|
|
Repayment of accrued interest |
|
4,117
|
|
Ryan [Member] |
|
|
|
Due to related party |
|
140,143
|
201,143
|
Accrued interest |
|
33,960
|
20,171
|
Stock issued in settlement of debt, principal |
|
35,095
|
|
Payments made to related party |
183,000
|
20,000
|
$ 95,600
|
SG Austria [Member] |
|
|
|
Manufacturing set up fee paid |
323,500
|
$ 323,500
|
|
Vin-de-Bona |
|
|
|
Professional fees |
$ 97,000
|
|
|
Gunzburg |
|
|
|
Stock issued for services |
500,000
|
|
|
Salmons |
|
|
|
Stock issued for services |
250,000
|
|
|
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13. INCOME TAXES (Details - Deferred tax assets) - USD ($)
|
Apr. 30, 2015 |
Apr. 30, 2014 |
Deferred tax assets: |
|
|
Net operating loss carryforwards |
$ 13,118,046
|
$ 21,328,813
|
Forgiveness of debt |
0
|
555,349
|
Other |
8,291
|
0
|
Total deferred tax assets |
13,126,337
|
21,884,162
|
Deferred tax liabilities: |
|
|
Shares issued for services |
0
|
5,701,048
|
Conversion of preferred stock |
0
|
2,004,300
|
Conversion of debt |
0
|
1,357,720
|
Total deferred tax liabilities |
0
|
9,063,068
|
Net deferred tax assets |
13,126,337
|
12,821,094
|
Valuation allowance |
(13,126,337)
|
(12,821,094)
|
Net deferred tax assets |
$ 0
|
$ 0
|
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13. INCOME TAXES (Details - Income tax provision) - USD ($)
|
12 Months Ended |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Income Tax Disclosure [Abstract] |
|
|
|
Federal benefit at statutory rate |
$ (3,375,420)
|
$ (8,871,790)
|
$ (543,355)
|
State income taxes, net of Federal taxes |
(540,564)
|
(1,420,791)
|
(87,017)
|
Permanent differences |
1,433,758
|
644,287
|
109,296
|
Provision related to change in valuation allowance |
305,243
|
364,071
|
256,694
|
Return to provision |
2,339,028
|
9,063,069
|
348,057
|
Other, net |
(162,065)
|
221,154
|
(83,675)
|
Provision for income taxes |
$ 0
|
$ 0
|
$ 0
|
X |
- DefinitionAmount of current state and local tax expense (benefit) pertaining to income (loss) from continuing operations.
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13. INCOME TAXES (Details Narrative) - USD ($)
|
12 Months Ended |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Income Tax Disclosure [Abstract] |
|
|
|
Net operating loss carryfrowrd |
$ 33,257,000
|
$ 33,257,000
|
|
Operating loss carryforward expiration date |
Dec. 31, 2033
|
|
|
Increase in valuation allowance |
$ 305,243
|
$ 364,071
|
$ 256,694
|
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- DefinitionAmount of operating loss carryforward, before tax effects, available to reduce future taxable income under enacted tax laws.
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14. EARNINGS PER SHARE (Details) - USD ($)
|
3 Months Ended |
12 Months Ended |
Apr. 30, 2015 |
Jan. 31, 2015 |
Oct. 31, 2014 |
Jul. 31, 2014 |
Apr. 30, 2014 |
Jan. 31, 2014 |
Oct. 31, 2013 |
Jul. 31, 2013 |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Earnings Per Share [Abstract] |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ (4,020,389)
|
$ (1,458,050)
|
$ (2,864,443)
|
$ (1,584,824)
|
$ (16,470,811)
|
$ (458,772)
|
$ (5,658,070)
|
$ (4,666,367)
|
$ (9,927,706)
|
$ (27,254,020)
|
$ (1,598,102)
|
Basic weighted average number of shares outstanding |
|
|
|
|
|
|
|
|
704,327,656
|
583,219,665
|
440,954,850
|
Diluted weighted average number of shares outstanding |
|
|
|
|
|
|
|
|
704,327,656
|
583,219,665
|
440,954,850
|
Basic and diluted loss per share |
$ (.01)
|
$ (0.00)
|
$ (0.01)
|
$ (0.00)
|
$ (.03)
|
$ 0.00
|
$ (.01)
|
$ (.01)
|
$ (.01)
|
$ (0.05)
|
$ 0.00
|
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v3.3.1.900
15. QUARTERLY FINANCIAL INFORMATION (Details) - USD ($)
|
3 Months Ended |
12 Months Ended |
Apr. 30, 2015 |
Jan. 31, 2015 |
Oct. 31, 2014 |
Jul. 31, 2014 |
Apr. 30, 2014 |
Jan. 31, 2014 |
Oct. 31, 2013 |
Jul. 31, 2013 |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Quarterly Financial Information Disclosure [Abstract] |
|
|
|
|
|
|
|
|
|
|
|
Net revenue |
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
$ 12,160
|
Cost of revenue |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9,620
|
Gross profit |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2,540
|
Operating expenses |
4,020,176
|
1,456,554
|
6,200,845
|
1,583,160
|
16,448,801
|
681,080
|
448,570
|
1,400,691
|
13,260,735
|
18,979,142
|
1,686,901
|
Other income (expenses), net |
(213)
|
(1,496)
|
3,336,402
|
(1,664)
|
(22,010)
|
222,308
|
(5,209,500)
|
(3,265,676)
|
3,333,029
|
(8,274,878)
|
86,259
|
Net loss |
$ (4,020,389)
|
$ (1,458,050)
|
$ (2,864,443)
|
$ (1,584,824)
|
$ (16,470,811)
|
$ (458,772)
|
$ (5,658,070)
|
$ (4,666,367)
|
$ (9,927,706)
|
$ (27,254,020)
|
$ (1,598,102)
|
Net loss per common share, Basic and Diluted |
$ (.01)
|
$ (0.00)
|
$ (0.01)
|
$ (0.00)
|
$ (.03)
|
$ 0.00
|
$ (.01)
|
$ (.01)
|
$ (.01)
|
$ (0.05)
|
$ 0.00
|
X |
- DefinitionThe aggregate cost of goods produced and sold and services rendered during the reporting period.
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v3.3.1.900
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS (Details) - USD ($)
|
12 Months Ended |
Apr. 30, 2015 |
Apr. 30, 2014 |
Apr. 30, 2013 |
Valuation and Qualifying Accounts [Abstract] |
|
|
|
Deferred tax assets, beginning balance |
$ 12,821,094
|
$ 12,457,023
|
$ 12,200,329
|
Additions charged to costs and expenses |
0
|
0
|
0
|
Charged to other accounts |
305,243
|
364,071
|
256,694
|
Deductions |
0
|
0
|
0
|
Deferred tax assets, ending balance |
$ 13,126,377
|
$ 12,821,094
|
$ 12,457,023
|
X |
- DefinitionDeferred tax assets additions charged to costs and expenses
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