Notes
to the Condensed Consolidated Financial Statements
June
30, 2017
(Unaudited)
1.
Organization and Description of Business
Immune
Therapeutics, Inc. (the “Company”) was initially incorporated in Florida on December 2, 1993 as Resort Clubs International,
Inc. (“Resort Clubs”). It was formed to manage and market golf course properties in resort markets throughout the
United States. Galliano International Ltd. (“Galliano”) was incorporated in Delaware on May 27, 1998 and began trading
in November 1999 through the filing of a 15C-211. On November 10, 2004, Galliano merged with Resort Clubs. Resort Clubs was the
surviving corporation. On August 23, 2010, Resort Clubs changed its name to pH Environmental Inc. (“pH Environmental”).
On
April 23, 2012, pH Environmental completed a name change to TNI BioTech, Inc., and on April 24, 2012, we executed a share exchange
agreement for the acquisition of all of the outstanding shares of TNI BioTech IP, Inc. On September 4, 2014, a majority of our
shareholders approved an amendment to our Amended and Restated Articles of Incorporation, as amended, to change our name to Immune
Therapeutics, Inc. We filed our name change amendment with the Secretary of State of Florida on October 27, 2014 changing our
name to Immune Therapeutics, Inc.
The
Company currently operates out of Orlando, Florida. In July 2012, the Company’s focus turned to acquiring patents that would
protect and advance the development of new uses of opioid-related immune- therapies, such as low dose naltrexone (“LDN”)
and Methionine [Met5]-enkephalin (“MENK”). The Company’s therapies are believed to stimulate and/or regulate
the immune system in such a way that they provide the potential to treat a variety of diseases. We believe our therapies may be
able to correct abnormalities or deficiencies in the immune system in diseases such as HIV infection, autoimmune disease, immune
disorders, or cancer; all of which can lead to disease progression and life-threatening situations when the immune system is not
functioning optimally.
In
October 2012, the Company formed TNI BioTech International, Ltd., a BVI company in Tortola, British Virgin Islands, which was
set up to allow the Company to market and sell LDN in those countries outside the U.S. in which we have been able to obtain approval
to sell the Company’s products.
In
August 2013, the Company formed its United Kingdom subsidiary, TNI BioTech, LTD (the “UK Subsidiary”). The UK Subsidiary
received approval to be considered a micro, small or medium-sized enterprise (“SME”) with the European Medicines Agency
(“EMA”) on August 21, 2013. The designation provides the UK Subsidiary with significant discounts when holding meetings
or submitting filings to the EMA. On September 19, 2013, the UK Subsidiary submitted a pre-submission package to the EMA regarding
Crohn’s Disease. The EMA granted the UK Subsidiary a meeting that took place on September 27, 2013. The UK Subsidiary is
eligible to benefit from the provisions for administrative and financial assistance for SMEs set out in Regulation (EC) No 2049/2005.
The Company will determine whether or not to apply to obtain EMA benefits once funding becomes available.
In
December 2013, the Company formed a new subsidiary, Cytocom Inc., to focus on conducting LDN and MENK clinical trials in the United
States. In December 2014, the Company finalized the distribution of common stock of Cytocom Inc. to its shareholders. As part
of the transaction, the Company retained exclusive rights to all international patents, in-country approvals, formulations, trademarks,
manufacturing, marketing, sales, and distributions rights in emerging nations, including Africa, Central America, South America,
Russia, India, China, Far East, and The Commonwealth of Independent States (former Soviet Union). The Company will continue to
have access to existing clinical data as well as any new data generated by Cytocom Inc. during drug development. On December 8,
2014, the number of Cytocom Inc. shares of common stock that were issued to our shareholders totaled 113,242,522 shares. In connection
with the transaction, Cytocom Inc. issued 140,100,000 shares of its common stock to the Company, which gave the Company a 55.3%
stake in Cytocom Inc. on that date. In April 2016, the Board of Directors and a majority of shareholders of Cytocom approved a
reverse stock split of Cytocom’s outstanding common stock with one new share of stock for each twenty old shares of common
stock. Cytocom effectuated and finalized the reverse split in June 2016. At June 30, 2017, the Company’s equity interest
had been further reduced to 12.8%, by subsequent issuances of Cytocom common stock to shareholders in settlement of notes payable.
In
March 2014, the Company incorporated Airmed Biopharma Limited, an Irish corporation with an address in Dublin, Ireland, and Airmed
Holdings Limited, an Irish company domiciled in Bermuda. The Irish companies were set up to benefit from incentives granted by
the Irish government for the establishment of pharmaceutical companies (many of the world’s leading pharmaceutical companies
have located in Ireland), and so that the Company could take advantage of Ireland’s status as a member of the European Union
and the European Economic Area. An Irish limited liability company enjoys a low corporate income tax rate of 12.5%, one of the
lowest in the world. The Irish-domiciled company hopes to qualify for tax incentives for Irish holding/headquartered companies
and to benefit from the network of double tax treaties that reduce withholding taxes. TNI BioTech International, Ltd. will manage
our international distribution, using product that is manufactured in Ireland and elsewhere.
Today,
Immune Therapeutics is focused on the commercialization of affordable non-toxic immunotherapies focused on the activation and
rebalancing of the body’s immune system. We believe that stimulating the body’s immune system remains one of the most
promising approaches in the treatment of Cancers, HIV, Autoimmune Diseases, inflammatory conditions and other opportunistic infections
for chronic often life-threatening diseases through the mobilization of the body’s immune system in Emerging Nations using
existing clinical data.
Cytocom
Inc, is a clinical-stage pharmaceutical company focused on the development of the first affordable non-toxic immunodulator for
the treatment of inflammatory diseases, immune-related disorders, and cancer and is responsible for the development of our patented
therapies with the FDA and EMA.
As
of this date, neither we nor our collaboration partners are permitted to market our drug candidates in the United States until
we receive approval of a New Drug Application from the FDA. Neither we nor our collaboration partners have submitted an application
for or received marketing approval for any of our drug candidates. Obtaining approval of an NDA can be a lengthy, expensive and
uncertain process.
Going
Concern
The
Company experienced a net loss from operations of $2,557,298, and used cash and cash equivalents for operations in the
amount of $1,231,051 during the six months ended June 30, 2017, resulting in stockholder’s deficit of $7,857,447 at that
date.
The
Company has incurred significant net losses since inception and has relied on its ability to fund its operations through private
equity financings. Management expects operating losses and negative cash flows to continue at more significant levels in the future.
As the Company continues to incur losses, transition to profitability is dependent upon the successful development, approval,
and commercialization of its product candidate and the achievement of a level of revenues adequate to support the Company’s
cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to
raise additional cash. Management intends to fund future operations through the sale of products, additional private or public
debt or equity offerings, and it may also seek additional capital through arrangements with strategic partners or from other sources.
Based on the Company’s operating plan, existing working capital at June 30, 2017 was not sufficient to meet the cash requirements
to fund planned operations through June 30, 2018 without additional sources of cash. These conditions raise substantial doubt
about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements have been
prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the
outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction
of liabilities in the normal course of business.
2.
Summary of Significant Accounting Policies
Basis
of Presentation
The
consolidated financial statements included herein have been prepared by the Company, without audit, pursuant to the rules and
regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial
statements prepared in accordance with U.S. generally accepted accounting principles have been omitted. However, in the opinion
of management, all adjustments (which include only normal recurring adjustments, unless otherwise indicated) necessary to present
fairly the financial position and results of operations for the periods presented have been made. The results for interim periods
are not necessarily indicative of trends or of results to be expected for the full year. These financial statements should be
read in conjunction with the financial statements of the Company for the year ended December 31, 2016 (including the notes thereto)
set forth in Form 10-K.
The
Company qualifies as an “emerging growth company” as defined in Section 101 of the Jumpstart our Business Startups
Act (“JOBS Act”) as we do not have more than $1,000,000,000 in annual gross revenue for the year ended December 31,
2016. We are electing to use the extended transition period for complying with new or revised accounting standards under Section
102(b)(1) of the JOBS Act.
Revenue
Recognition
We
recognize revenue on sales to customers and distributors upon satisfaction of our performance obligations when the goods are shipped.
For consignment sales, we recognize revenue when the goods are pulled from consignment inventory.
In
May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single
set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. It is effective
for annual and interim reporting periods beginning after December 15, 2017. This standard permits early adoption and permits the
use of either the retrospective or cumulative effect transition method. We are currently evaluating the potential impact of this
standard on our financial position and results of operations, as well as our selected transition method. Based on our preliminary
assessment, we believe the new standard will not have a material impact on our financial position and results of operations, as
we do not expect to change the manner or timing of recognizing revenue on a majority of our revenue transactions once we commence
revenue-generating activities.
Leases
In
February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). This standard requires all leases that have a term of over
12 months to be recognized on the balance sheet with the liability for lease payments and the corresponding right-of-use asset
initially measured at the present value of amounts expected to be paid over the term. Recognition of the costs of these leases
on the income statement will be dependent upon their classification as either an operating or a financing lease. Costs of an operating
lease will continue to be recognized as a single operating expense on a straight-line basis over the lease term. Costs for a financing
lease will be disaggregated and recognized as both an operating expense (for the amortization of the right-of-use asset) and interest
expense (for interest on the lease liability). This standard will be effective for our interim and annual periods beginning January
1, 2019, and must be applied on a modified retrospective basis to leases existing at, or entered into after, the beginning of
the earliest comparative period presented in the financial statements. Early adoption is permitted. We are currently evaluating
the timing of adoption and the potential impact of this standard on our financial position, but we do not expect it to have a
material impact on our results of operations.
Use
of Estimates
The
preparation of the Company’s financial statements in conformity with U.S. generally accepted accounting principles requires
management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes.
Actual results could differ from such estimates.
Cash,
Cash Equivalents, and Short-Term Investments
The
Company considers all highly liquid investments with original maturities at the date of purchase of three months or less to be
cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months
or less at purchase, and money market funds that invest primarily in certificates of deposits, commercial paper and U.S. government
and U.S. government agency obligations. Cash equivalents are reported at fair value.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The
Company is exposed to credit risk, subject to federal deposit insurance, in the event of a default by the financial institutions
holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets. The cash accounts are insured by
the Federal Deposit Insurance Corporation up to $250,000. At June 30, 2017, the Company has no cash balances in excess of insured
limits.
Segment
and Geographic Information
Operating
segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the
chief operating decision maker, or decision making group, in deciding how to allocate resources and in assessing performance.
The Company views its operations and manages its business in one operating segment and does not segment the business for internal
reporting or decision making.
Fair
Value of Financial Instruments
In
accordance with the reporting requirements of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC)
Topic 825, “
Financial Instruments”
, the Company calculates the fair value of its assets and liabilities which
qualify as financial instruments under this standard and includes this additional information in the notes to the financial statements
when the fair value is different than the carrying value of those financial instruments. Cash and accounts payable are accounted
for at cost which approximates fair value due to the relatively short maturity of these instruments. The carrying value of notes
payable also approximate fair value since they bear market rates of interest and other terms. None of these instruments are held
for trading purposes.
Fair
Value Measurements
The
ASC Topic 820,
Fair Value Measurement,
defines fair value, establishes a framework for measuring fair value in accordance
with U.S. generally accepted accounting principles, and requires certain disclosures about fair value measurements. In general,
fair values of financial instruments are based upon quoted market prices, where available. If such quoted market prices are not
available, fair value is based upon internally developed models that primarily use, as inputs, observable market-based parameters.
Valuation adjustments may be made to ensure that financial instruments are recorded at fair value. These adjustments may include
amounts to reflect counterparty credit quality and the customer’s creditworthiness, among other things, as well as unobservable
parameters. Any such valuation adjustments are applied consistently over time.
Fixed
Assets
Fixed
assets are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated
useful lives of the assets, which generally range from three to five years. Maintenance and repairs are charged against expense
as incurred. Depreciation expense for the three months ended June 30, 2017 and June 30, 2016 was $144 and $434, respectively.
Impairment
of Long-Lived Assets
The
Company evaluates long-lived assets for impairment whenever events or change in circumstances indicate that the carrying amount
of an asset may not be recoverable as prescribed by ASC Topic 360-10-05, “
Property, Plant and Equipment
.” If
the carrying amount of the asset, including any intangible assets associated with that asset, exceeds its estimated undiscounted
net cash flow, before interest, the Company will recognize an impairment loss equal to the difference between its carrying amount
and its estimated fair value.
Research
and Development Costs
Research
and development costs are charged to expense as incurred and are typically comprised of salaries and benefits, pre-clinical studies,
clinical trial activities, drug development and manufacturing, fees paid to consultants and other entities that conduct certain
research and development activities on the Company’s behalf and third-party service fees, including clinical research organizations
and investigative sites. Costs for certain development activities, such as clinical trials are recognized based on an evaluation
of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information
provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements,
which may differ from the pattern of costs incurred, and are reflected in the financial statements as operating expenses.
Income
Taxes
The
Company follows ASC Topic 740,
Income Taxes,
which requires recognition of deferred tax assets and liabilities for the
expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method,
deferred tax assets and liabilities are based on the differences between the financial statements and tax bases of assets and
liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets
are reduced by a valuation allowance to the extent management concludes it is more likely than not that the asset will not be
realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be recovered or settled.
The
standard addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded
in the financial statements. Under ASC Topic 740, the Company may recognize the tax benefit from an uncertain tax position only
if it is more likely than not that the tax position will be sustained on examination by the tax authorities, based on the technical
merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based
on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. ASC Topic
740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods
and requires increased disclosures. At the date of adoption, and as of June 30, 2017 and 2016, the Company does not have a liability
for unrecognized tax uncertainties.
The
Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. As of June 30, 2017,
and 2016, the Company has not accrued any interest or penalties related to uncertain tax positions.
Stock-Based
Compensation and Issuance of Stock for Non-Cash Consideration
The
Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including
employee stock options, based on estimated fair values equaling either the market value of the shares issued or the value of consideration
received, whichever is more readily determinable. The majority of the non-cash consideration pertains to services rendered by
consultants and others and has been valued at the fair value of the Company’s common stock at the date of the agreement.
The
Company’s accounting policy for equity instruments issued to consultants and vendors in exchange for goods and services
follows the provisions of ASC Topic 505-50, “
Equity-Based Payments to Non-Employees
.” The measurement date
for the fair value of the equity instruments issued is determined at the earlier of (i) the date at which a commitment for performance
by the consultant or vendor is reached or (ii) the date at which the consultant or vendor’s performance is complete.
Non-controlling
Interest
In
accordance with ASC Topic 810,
Consolidation
, the Company consolidates Cytocom, Inc. The non-controlling interests in Cytocom
represent the interests of outside shareholders in the equity and results of operations of Cytocom.
Net
Income (Loss) per Share
Basic
net income (loss) per share (“EPS”) is calculated in accordance with Accounting Standards Codification (“ASC”)
260, “Earnings Per Share.” Basic net income or loss per share is calculated by dividing the net loss attributable
to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common
stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common
share equivalents outstanding for the period determined using the treasury-stock method. Dilutive
common stock equivalents are comprised of common stock purchase warrants outstanding.
A
calculation of basic net income (loss) per share follows:
|
|
For
the three months ended
June 30,
|
|
|
For
the six months ended
June 30,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Profit/(Loss)
|
$
|
|
148,635
|
|
$
|
|
(4,038,648)
|
|
$
|
|
(2,557,298)
|
|
$
|
|
(10,684,051)
|
|
Weighted-average common shares outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic:
|
|
|
304,232,895
|
|
|
|
207,229,469
|
|
|
|
281,886,367
|
|
|
|
199,076,428
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equivalents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Warrants
|
|
|
9,345,386
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Convertible notes
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
313,578,281
|
|
|
|
207,229,469
|
|
|
|
281,886.367
|
|
|
|
199,076,428
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit/(Loss) per share outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
0.00
|
|
|
$
|
(0.02
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
(0.05
|
)
|
The
Company’s potential dilutive securities, which include warrants, have been excluded from the computation of diluted net
loss per share as the effect would be to reduce the net loss per share.
The
following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares
outstanding:
|
|
As
of June 30,
|
|
|
|
2017
|
|
|
2016
|
|
Warrants
to purchase Common stock
|
|
|
44,619,000
|
|
|
|
32,748,908
|
|
|
|
|
44,619,000
|
|
|
|
32,748,908
|
|
Recent
Accounting Standards
During
the quarter ended June 30, 2017, there were several new accounting pronouncements issued by the Financial Accounting Standards
Board. Each of these pronouncements, as applicable, has been or will be adopted by the Company. Management does not believe the
adoption of any of these accounting pronouncements has had or will have a material impact on the Company’s consolidated
financial statements.
In
May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single
set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. It is effective
for annual and interim reporting periods beginning after December 15, 2017. This standard permits early adoption and permits the
use of either the retrospective or cumulative effect transition method. We are currently evaluating the potential impact of this
standard on our financial position and results of operations, as well as our selected transition method. Based on our preliminary
assessment, we believe the new standard will not have a material impact on our financial position and results of operations, as
we do not expect to change the manner or timing of recognizing revenue on a majority of our revenue transactions.
In
February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). This standard requires all leases that have a term of over
12 months to be recognized on the balance sheet with the liability for lease payments and the corresponding right-of-use asset
initially measured at the present value of amounts expected to be paid over the term. Recognition of the costs of these leases
on the income statement will be dependent upon their classification as either an operating or a financing lease. Costs of an operating
lease will continue to be recognized as a single operating expense on a straight-line basis over the lease term. Costs for a financing
lease will be disaggregated and recognized as both an operating expense (for the amortization of the right-of-use asset) and interest
expense (for interest on the lease liability). This standard will be effective for our interim and annual periods beginning January
1, 2019, and must be applied on a modified retrospective basis to leases existing at, or entered into after, the beginning of
the earliest comparative period presented in the financial statements. Early adoption is permitted. We are currently evaluating
the timing of adoption and the potential impact of this standard on our financial position, but we do not expect it to have a
material impact on our results of operations.
3.
Fixed Assets
|
|
June
30, 2017
|
|
|
December
31, 2016
|
|
Fixed
Assets:
|
|
|
|
|
|
|
|
|
Computer
equipment
|
|
$
|
11,243
|
|
|
$
|
9,738
|
|
Less
accumulated depreciation
|
|
|
(8,176
|
)
|
|
|
(7,888
|
)
|
Property
and equipment, net
|
|
$
|
3,067
|
|
|
$
|
1,850
|
|
The
Company utilizes the straight-line method for depreciation, using three to five-year depreciable asset lives. Depreciation expense
was not material for all periods presented.
4.
Accrued Liabilities
Accrued
expenses and other liabilities consist of the following:
|
|
June
30, 2017
|
|
|
December
31, 2016
|
|
|
|
|
|
|
|
|
Accrued
payroll to officers and others
|
|
$
|
1,169,883
|
|
|
$
|
1,126,261
|
|
Accrued
interest and penalties - notes payable
|
|
|
517,467
|
|
|
|
1,902,018
|
|
Estimated
legal settlement
|
|
|
111,644
|
|
|
|
128,087
|
|
Other
accrued liabilities
|
|
|
393
|
|
|
|
393
|
|
|
|
|
|
|
|
|
|
|
Total
accrued expenses and other liabilities
|
|
$
|
1,799,387
|
|
|
$
|
3,156,759
|
|
5.
Notes Payable
Notes
payable consist of the following:
|
|
June
30, 2017
|
|
|
December
31, 2016
|
|
Promissory
note issued July 29, 2014 to Ira Gaines. In 2016, the maturity date on the note was extended to December 1, 2017. The note
earns interest at a rate of 18% per annum.
|
|
$
|
100,000
|
|
|
$
|
100,000
|
|
|
|
|
|
|
|
|
|
|
Promissory
notes issued between November 26, 2014 and September 30, 2015, to raise up to $2,000,000 in debt. Lenders earn interest at
a rate of 10% per annum, plus a pro-rata share of two percent of the Company’s gross receipts for sales of IRT-103-LDN
in perpetuity. Notes will be repaid in 36 monthly installments of principal and interest commencing no later than October
15, 2015. Notes aggregating $286,000 were in default at June 30, 2017, as the Company was unable to pay installments on those
notes on their due dates. No demands for repayment have been made by the lenders.
|
|
|
286,000
|
|
|
|
286,000
|
|
|
|
|
|
|
|
|
|
|
Promissory
notes issued between May 1, 2015 and December 31, 2016, and maturing between June 14, 2015 and September 30, 2017. Lenders
on loans aggregating $505,994 earn interest at rates between 2% and 18% per annum. On loans aggregating $198,500, interest
is payable in a fixed amount not tied to a specific interest rate. Notes aggregating $555,494 were in default at June
30, 2017, as the Company was unable to repay those notes on their due dates. No demands for repayment have been made by the
lenders.
|
|
|
704,494
|
|
|
|
704,494
|
|
|
|
|
|
|
|
|
|
|
Promissory
notes issued by Cytocom Inc. between April 29, 2015 and December 31, 2015. Lenders earn interest at rates between 5% and 10%
per annum. These notes mature on September 30, 2016. At June 30, 2017, the notes were in default, although no demand for repayment
has been made by the lenders.
|
|
|
425,000
|
|
|
|
425,000
|
|
|
|
|
|
|
|
|
|
|
Promissory
note issued in December 2015. The lender earns interest at a rate of 10% per month. The note is repayable on March 9, 2016.
At June 30, 2017, the note was in default, although no demand for repayment has been made by the lender. On April 3, 2017,
the Company settled the obligation.
|
|
|
-
|
|
|
|
100,000
|
|
Promissory
notes issued between May 5, 2016 and June 2, 2016 that mature between October 1, 2016 and January 31, 2017, and include stock
conversion features, warrants and original issue debt discounts. The notes were repaid or converted into stock in the quarter
ended June 30, 2017.
|
|
|
-
|
|
|
|
554,882
|
|
|
|
|
|
|
|
|
|
|
Promissory
notes issued to an officer of the Company effective November 3, 2015 and maturing November 3, 2016 for settlement of accrued
payroll, bearing interest at 10% per annum and including a stock conversion feature. The Company was unable to repay the note
at maturity and the note is in default.
|
|
|
102,737
|
|
|
|
112,737
|
|
|
|
|
|
|
|
|
|
|
Promissory
note issued in July 2016. The note was repayable on October 5, 2016 but was extended to December 31, 2016. The note earns
interest at 6% per month. The Company was unable to repay the note at maturity and the note is in default.
|
|
|
50,000
|
|
|
|
50,000
|
|
|
|
|
|
|
|
|
|
|
Promissory
note issued in July 2016 with an original issuance discount of $30,000. Net proceeds were $150,000. The note is repayable
on April 7, 2017. $66,000 of the note was converted to stock. The Company was unable to repay the note at maturity and the
note is in default.
|
|
|
114,000
|
|
|
|
180,000
|
|
|
|
|
|
|
|
|
|
|
Promissory
notes issued in August 2016 for $149,854 as a settlement of amounts owed to a law firm. The notes accrue interest at 5% per
annum and are payable in 18 equal monthly installments of $8,641.88. The note was in default on June 30, 2017.
|
|
|
69,135
|
|
|
|
120,987
|
|
|
|
|
|
|
|
|
|
|
Promissory
notes issued between July 1, 2016 and December 31, 2016. Lenders earn interest at 2% per annum. The notes mature on September
30, 2017.
|
|
|
256,000
|
|
|
|
256,000
|
|
|
|
|
|
|
|
|
|
|
Notes
aggregating $1,354,000 issued in the fourth quarter of 2016. The notes accrue interest at 2% per annum and mature between
November 1, 2017 and December 31, 2017.
|
|
|
1,354,000
|
|
|
|
1,354,000
|
|
|
|
|
|
|
|
|
|
|
Notes
aggregating $500,000 issued in the first quarter of 2017. The notes accrue interest at 2% per annum and mature between January
12, 2018 and June 30, 2018.
|
|
|
500,000
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Promissory
note issued January 25, 2017. The lenders earn interest at 7% per month. The note matures on July 5, 2017.
|
|
|
50,000
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Notes
aggregating $300,000 issued in the second quarter of 2017. The notes accrue interest at 2% per annum and mature between January
12, 2018 and June 30, 2018.
|
|
|
300,000
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Less:
Original issue discounts on notes payable and warrants issued with notes.
|
|
|
-
|
|
|
|
(18,681
|
)
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
4,311,366
|
|
|
$
|
4,225,419
|
|
As
of June 30, 2017, the Company had accrued $517,467 in unpaid interest and default penalties. During the quarter ended June 30,
2017, 20,282,473 shares with a fair value of $874,024 were issued by the Company for settlement of promissory notes.
6.
Capital Structure—Common Stock and Common Stock Purchase Warrants
Each
holder of common stock is entitled to vote on all matters and is entitled to one vote for each share held. No holder of shares
of stock of any class shall be entitled as a matter of right to subscribe for or purchase or receive any part of any new or additional
issue of shares of stock of any class, or of securities convertible into shares of stock or any class, whether now hereafter authorized
or whether issued for money, for consideration other than money, or by way of dividend.
As
of June 30, 2017 and 2016, the Company was authorized to issue 500,000,000 common shares at a par value of $0.0001 per share.
As
of June 30, 2017, the Company had 332,689,818 shares of common stock outstanding, and 250,428,133 outstanding as of December 31,
2016.
Stock
Warrants
In
the quarter ended June 30, 2017, there were 14,750,000 new warrants issued by the Company.
There
were no modifications of the terms of any warrants issued by the Company in the quarters ended June 30, 2017. In the quarter ended
June 30, 2016, the Company extended to December 31, 2018 the maturity dates on 5,006,666 existing warrants that were originally
issued with expiration dates between July 25, 2016 to December 17, 2018. These warrants were originally issued with 3 to 5 year
terms, with exercise prices ranging between $0.75 and $1.00.
Following
is a summary of outstanding stock warrants at June 30, 2017 and activity during the six months then ended:
|
|
Number
of
Shares
|
|
|
Exercise
Price
|
|
|
Weighted
Average
Price
|
|
Warrants
as of December 31, 2016
|
|
|
59,191,904
|
|
|
$
|
0.03-15.00
|
|
|
$
|
0.35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued
in 2017
|
|
|
14,750,000
|
|
|
$
|
0.05-0.20
|
|
|
$
|
0.08
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired
and forfeited in 2017
|
|
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
in 2017
|
|
|
5,600,000
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants
as of June 30, 2017
|
|
|
68,341,904
|
|
|
$
|
0.03-15.00
|
|
|
$
|
0.31
|
|
Summary
of outstanding warrants as of June 30, 2017:
Expiration
Date
|
|
Number
of
Shares
|
|
|
Exercise
Price
|
|
|
Remaining
Life (years)
|
|
|
|
|
|
|
|
|
|
|
|
Fourth
Quarter 2017
|
|
|
350,000
|
|
|
$
|
1.50-9.00
|
|
|
|
0.25
|
|
First
Quarter 2018
|
|
|
127,500
|
|
|
$
|
15.00
|
|
|
|
0.50
|
|
Second
Quarter 2018
|
|
|
33,334
|
|
|
$
|
15.00
|
|
|
|
0.75
|
|
Third
Quarter 2018
|
|
|
250,000
|
|
|
$
|
1.50
|
|
|
|
1.00
|
|
Fourth
Quarter 2018
|
|
|
6,089,166
|
|
|
$
|
1.00-1.50
|
|
|
|
1.25
|
|
First
Quarter 2019
|
|
|
4,024,000
|
|
|
$
|
0.50-2.00
|
|
|
|
1.50
|
|
Second
Quarter 2019
|
|
|
135,000
|
|
|
$
|
0.07-0.23
|
|
|
|
1.75
|
|
Third
Quarter 2019
|
|
|
260,000
|
|
|
$
|
0.50-1.50
|
|
|
|
2.00
|
|
Fourth
Quarter 2019
|
|
|
400,000
|
|
|
$
|
0.14
|
|
|
|
2.25
|
|
Second
Quarter 2020
|
|
|
300,000
|
|
|
$
|
0.50
|
|
|
|
2.75
|
|
Fourth
Quarter 2020
|
|
|
1,000,000
|
|
|
$
|
0.20
|
|
|
|
3.25
|
|
First
Quarter 2021
|
|
|
12,600,000
|
|
|
$
|
0.20
|
|
|
|
3.50
|
|
Second
Quarter 2021
|
|
|
21,206,237
|
|
|
$
|
0.03-0.20
|
|
|
|
3.75
|
|
Third
Quarter 2021
|
|
|
6,816,667
|
|
|
$
|
0.03-0.20
|
|
|
|
4.00
|
|
Second
Quarter 2022
|
|
|
3,250,000
|
|
|
$
|
0.20
|
|
|
|
4.75
|
|
Second
Quarter 2032
|
|
|
11,500,000
|
|
|
$
|
0.05
|
|
|
|
14.75
|
|
7.
Stock Compensation
Shares
Issued for Services
During the six months ended June 30,
2017 and 2016, the Company issued 25,545,460 and 23,643,000 shares of common stock respectively for consulting fees. The
Company valued these shares at $1,265,456 and $4,543,170 respectively, based upon the fair value of the common stock at the dates
of the agreements. The consulting fees are amortized over the contract periods which are typically between 12 and 24 months. The
amortization of prepaid services totaled $885,835 and $1,539,928 for the six months ended June 30, 2017 and 2016.
8.
Income Taxes - Results of Operations
The Company considers the likelihood of
changes by tax authorities in its filed income tax returns and recognizes a liability for or discloses potential significant changes
that management believes are more likely than not to occur upon examination by tax authorities. Management has not identified
any uncertain tax positions in income tax returns filed that require recognition or disclosure in the accompanying financial statements.
The Company’s income tax returns for the past three years are subject to examination by tax authorities, and may change
upon examination.
For financial reporting purposes, for the
six months ending June 30, 2017 and 2016, income before income taxes includes the following components:
|
|
June 30, 2017
|
|
|
June 30, 2016
|
|
United States
|
|
$
|
(2,557,298
|
)
|
|
$
|
(10,684,051
|
)
|
Foreign
|
|
|
-
|
|
|
|
-
|
|
Total
|
|
$
|
(2,557,298
|
)
|
|
$
|
(10,684,051
|
)
|
The expense (benefit) for income taxes
consist of:
|
|
2017
|
|
|
2016
|
|
Current:
|
|
|
|
|
|
|
Federal
|
|
$
|
-
|
|
|
$
|
-
|
|
State
|
|
$
|
-
|
|
|
$
|
-
|
|
Foreign
|
|
$
|
-
|
|
|
$
|
-
|
|
Total
|
|
$
|
-
|
|
|
$
|
-
|
|
Deferred and other:
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
-
|
|
|
$
|
-
|
|
State
|
|
$
|
-
|
|
|
$
|
-
|
|
Foreign
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Total tax expense
|
|
$
|
-
|
|
|
$
|
-
|
|
The
Company has recognized no tax benefit for the losses generated for the periods through December 31, 2016. ASC Topic 740 requires
that a valuation allowance be provided if it is more likely than not that some portion or all of a deferred tax asset will not
be realized. The Company’s ability to realize the benefit of its deferred tax asset will depend on the generation of future
taxable income. Because the Company has yet to recognize revenue, we believe that the full valuation allowance should be provided.
Our
effective tax rate for fiscal years 2016 and 2015 was 0%. Our tax rate can be affected by recurring items, such as tax rates in
foreign jurisdictions and the relative amount of income we earn in jurisdictions. It may also be affected by discrete items that
may occur in any given year, but are not consistent from year to year.
As
of December 31, 2016, we had estimated federal and state income tax net operating loss (“NOL”) carry-forwards of approximately
$79,900,000, which will expire in 2032-2035.
9.
Licenses and Supply Agreements
Patent
and Subsidiary Acquisition
The
Company entered into a share exchange agreement on April 24, 2012 to acquire all of the outstanding shares of TNI BioTech IP,
Inc. (“TNI IP”), a biotechnology firm incorporated in Florida and formed to acquire patents related to the treatment
of cancer and HIV/AIDS and autoimmune diseases, using Met-enkephalin (“MENK”) and Naltrexone (“LDN”).
The goal of TNI IP’s management was to enable mankind and civilization to combat fatal diseases by activating and mobilizing
the body’s own immune system using TNI IP’s patented use of MENK. The first patents acquired by TNI IP were acquired
from Dr. Nicholas P. Plotnikoff and Professor Fengping Shan in 2012. TNI IP was acquired in exchange for 20,250,000 shares of
the Company’s common stock, of which 8,000,000 shares were issued to Dr. Plotnikoff for the acquisition of patents and the
remaining 12,250,000 shares were issued to the founders of TNI IP in exchange for all of their right, title and interest in their
TNI IP shares. The goodwill arising on the acquisition of TNI BioTech IP, Inc. was valued at $98,000,000 and license agreements
arising from the acquisition of TNI IP were valued at $16,006,000.
In
connection with the share exchange, we entered into a Sale of Technology Agreement with Dr. Nicholas P. Plotnikoff on March 4,
2012, wherein Dr. Plotnikoff agreed to transfer and assign all of his rights, title and interest in: European Patent United Kingdom,
Germany, France, Ireland EP 1401471 BI Methods for inducing sustained immune response; Russian Patent Russian Federation patent
number 2313364; The Patent Office of the People’s Republic of China, Application No.: 200810165784.8 China Patent CN1015113407
A The Patent Office of the People’s Republic of China ISSN: 1006-2858 CN 21-1349/R; Patent Agencies Government of India
Patent, Application number 1627/KOLNP/2003 number 220265 an Enkephalin Peptide Composition; and the US Patent Pending, US Patent
Application 10/146.999 e. The Company received all the production formulations and technology designs from Dr. Plotnikoff necessary
for the manufacturing, formulation, production and protocols of the MENK treatment of cancer and HIV/AIDS. As consideration for
entering into the Sale of Technology Agreement, Dr. Plotnikoff received 8,000,000 shares of common stock, a royalty of a single-digit
percentage on all sales of MENK and was granted the position of Non-Executive Chairman of the Board of Directors.
At
the time of the acquisition, the valuation of goodwill and other intangible assets were determined using the fair market price
for the Company’s common stock, which were exchanged for shares of TNI IP. In the fourth quarter of 2012, the Company performed
an annual valuation to determine whether any goodwill or intangible assets that had been acquired by the Company were impaired.
The result of this valuation was that material impairments were identified. The Company recognized an impairment of the goodwill
arising on the acquisition of TNI IP of $98,000,000.
Patent
License Agreements
On
August 13, 2012, the Company signed an exclusive License Agreement with Ms. Jacqueline Young (the “Young Agreement”)
for the intellectual property developed by Dr. Bernard Bihari relating to treatments with opioid antagonists such as naltrexone
and Met-enkephalin for a variety of diseases and conditions including malignant lymphoma, chronic lymphocytic leukemia, Hodgkin’s
lymphoma, and non-Hodgkin’s lymphoma, chronic herpes virus infections, chronic herpes viral infections such as chronic genital
herpes caused by the herpes simplex virus Type 2 and chronic infections due to the Epstein-Barr virus and a treatment method for
humans infected with HTLV-III (AIDS) virus, including patients clinically diagnosed as suffering from AIDS and those suffering
from AIDS-related complex (ARC). The Bihari patents were acquired in exchange for 540,000 shares of the Company’s common
stock with a fair value of $972,000 and assumed liabilities of $400,000, which is payable to Ms. Young over a twenty-four month
period in equal installments to reimburse her for the costs of a New York City office in accordance with the Young Agreement.
The patent liability at December 31, 2013 totaled $118,333. The cost of the patent totaled $1,372,000. Additionally, the Company
will pay the licensor a royalty payment of 1% of gross MENK sales and provide the licensor a position as non-executive chairman
of the Company. The Young Agreement is valid for the life of the patents and expires on a country by country basis in each country
where patent rights exist, upon the expiration of the last to expire patent in each country or in the event the patent in such
country is held to be invalid and/or unenforceable (by a court or government body of competent jurisdiction) or admitted to be
invalid or unenforceable. Additionally, we can cancel the Young Agreement upon 120 days’ written notice and shall pay all
royalties and fees that have accrued under the Young Agreement. We have the exclusive rights to the intellectual property; however,
Ms. Young retains a right to practice the patents licensed under the Young Agreement solely for noncommercial, academic research
purposes.
On
December 24, 2012, the Company signed an agreement for the acquisition of patent rights (the “Smith Agreement”) for
the intellectual property of Dr. Jill Smith and LDN Research Group, LLC (collectively, the “Licensor Parties”), whose
members are Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky and orphan drug designation by the FDA to a novel
late-stage drug, trademarked “LDN,” for the treatment of Pediatric Crohn’s disease. The patent covers methods
and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low doses as an opioid
antagonist. These patents were acquired in exchange for 300,000 shares of our common stock with a fair value of $2,715,000 and
payment of $165,384 (consisting of a $100,000 initial license fee and payment of $65,384 of expenses), which totaled $2,880,384.
The
Smith Agreement requires the Company to (i) use commercially reasonable efforts to develop, commercialize, market and sell licensed
products in a manner consistent with a business plan, (ii) expend a minimum amount of funds per annum to develop and commercialize
licensed products as soon as practicable, (iii) obtain all requisite regulatory approvals needed to use or sell licensed products
in the field of use, and (iv) make the first commercial sale of a licensed product by March of 2017. As of June 30, 2017, the
Company had not made a commercial sale of licensed product. Under the Smith Agreement, if the licensors determine that the Company
has not fulfilled its obligations, they may furnish the Company with written notice of such determination, in which case the Company
must either fulfill the obligation or negotiate a mutually acceptable revised commitment. As of the date of the filing of this
Form 10-Q, the licensors had not provided any such notice of determination under the agreement.
The
Company is required to pay an annual license fee, an annual running royalty on net sales of each licensed product or a minimum
royalty, whichever is greater, and a sublicense fee on payments received by the Company from sublicensees. The Company has an
exclusive, worldwide license to make, have made, use, lease, import, offer for sale and sell licensed products and to use the
method under the patent rights. The Smith Agreement will terminate on the expiration or abandonment of the last patent to expire
or ten years after the sale of the first licensed product. The Company may terminate the Smith Agreement upon 90 days’ written
notice, provided all sublicenses are terminated and all amounts due and owing are paid to the Licensor Parties. The Licensor Parties
may terminate the agreement ten days’ after notice to the Company if the Company is ten days late in payment or there is
a breach that remains uncured for ten days after written notice of such breach.
The
Company is also required to pay milestone payments after substantial achievement of certain milestone events for each licensed
product including payment: upon initiation of each Phase III trial; upon positive completion of each Phase III clinical trial
of the therapeutic use of an LDN compound in the field of use; when a New Drug Application (“NDA”) is accepted for
review by the FDA; and when FDA approval to market the NDA is approved. The Company will issue shares upon reaching certain milestones
including upon the first dosing of the first patient in a Phase III clinical trial for each licensed product, upon the first sale
of each licensed product, and upon the achievement of a set dollar amount in cumulative sales for each licensed product covered
by NDAs.
As
part of the Smith Agreement, the Company has the right to apply to the FDA for the transfer of the orphan drug status for the
use of naltrexone for the treatment of pediatric Crohn’s disease and ulcerative colitis, the Investigation New Drug Application
(“IND”), and the right to acquire the relevant clinical data set from Dr. Jill Smith. Dr. Jill Smith made arrangements
to transfer the IND to the Company as well as the relevant clinical data set, and the FDA has acknowledged that the Company is
now the sponsor for this IND.
On
September 24, 2014, the Company and the Licensor Parties jointly agreed to terminate the Smith Agreement, and in place thereof,
have the Licensor Parties grant a similar license in their patent rights to Cytocom Inc. pursuant to a Patent License Agreement
between the Licensor Parties, Cytocom Inc. and the Company with substantially similar terms as set forth in the Smith Agreement.
Pursuant to this agreement, the Company issued 1,000,000 shares of its common stock valued at $270,000, upon execution to the
Licensor Parties and the Company guaranteed the obligations of Cytocom Inc. to the Licensor Parties under the agreement.
On
January 18, 2013, the Company signed an exclusive licensing agreement with The Penn State Research Foundation to license all of
the intellectual property developed by Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Dr. Jill P. Smith for the treatment of
cancer titled “Opioid Growth Factor and Cancer” and “Combination Therapy with Opioid Growth Factor and Taxanes
for the Treatment of Cancer” (the “Foundation Agreement”).
The
Foundation Agreement requires the Company to: (a) use commercially reasonable efforts to develop, commercialize, market and sell
licensed products in a manner consistent with a business plan; (b) expend a minimum amount of funds per annum to develop and commercialize
licensed products as soon as practicable; (c) obtain all requisite regulatory approvals needed to use or sell licensed products
in the field of use; and (d) make the first commercial sale of a licensed product by December 31, 2016. As of June 30, 2017, the
Company had not made a commercial sale of licensed product. Under the Foundation Agreement, if the licensor determines that the
Company has not fulfilled its obligations, it may furnish the Company with written notice of such determination, in which case
the Company must either fulfill the obligation or negotiate a mutually acceptable revised commitment. As of the date of the filing
of this Form 10-Q, the licensor had not provided any such notice of determination under the agreement.
The
Foundation Agreement provides that the Company must pay to the licensor an initial license fee, a license maintenance fee on each
anniversary of the effective date of the Foundation Agreement, and an annual running royalty on net sales for each licensed product
or a minimum royalty, whichever is greater. In addition, the Company must pay a sublicense fee on payments received by the Company
from sublicensees.
The
Foundation Agreement also requires the Company to make payments upon the achievement of certain milestone events including: initiation
of each Phase II trial; initiation of each Phase III trial; when the NDA is accepted for review by the FDA; and when FDA approval
to market is approved. The Company must also issue shares upon certain milestones including upon the first dosing of the first
patient in a Phase II clinical trial for each licensed product, upon the first dosing of the first patient in a Phase III clinical
trial for each licensed product, upon the first sale of each licensed product, and upon the achievement of a set dollar amount
of cumulative sales for each licensed product covered by NDAs.
The
Foundation Agreement terminates on the expiration or abandonment of the last patent to expire or become abandoned. The Company
may terminate the Foundation Agreement at any time upon 60 days’ prior written notice and ceasing to make and sell all licensed
products, the termination of all sublicenses and payment of all monies owed under the Foundation Agreement. The licensor may terminate
the agreement 30 days after notice to the Company if the Company is 30 days late in payment or a breach that remains uncured for
45 days after written notice of such breach.
In
May of 2013, the Company executed a Patent License Agreement with Professor Fengping Shan (the “Shan Agreement”) pursuant
to which it obtained exclusive rights to develop and commercialize the licensed technology. The licensed technology is the intellectual
property developed and owned by Professor Shan (i) relating to the treatment of a variety of diseases and conditions with MENK
including multiple forms of lymphoma and cancer and (ii) a treatment method for humans infected with the HLTV-III (AIDS) virus
including AIDS and AIDS related complex (ARC). The licensed technology includes the methods and formulations for these treatments
including all INDs, communications with regulatory agencies, patient data, and letters relating to these treatments. The licensed
technology also includes certain patents developed by Professor Shan. Under the Shan Agreement, the Company must issue 500,000
shares to Professor Shan upon final transfer of the licenses, and reimburse Professor Shan for all out of pocket expenses in connection
with the patents. The Company will pay Professor Shan a running royalty on gross sales subject to decreases if third party intellectual
property is needed to complete such sale or product. The Shan Agreement lasts for the duration of each of the licensed patents
however the Company may terminate the Shan Agreement on 120 days’ written notice to Professor Shan.
On
August 6, 2014, Professor Fengping Shan executed an Assignment pursuant to which he transferred to the Company his entire right,
title and interest in and to the licensed patents under the Shan Agreement and CN 201210302259 Application of combination of low-dose
naltrexone and methionine-enkephalin to preparation of anti-cancer drug for the consideration of 500,000 shares of common stock
valued at $140,000.
10.
Commitments and Contingencies
Malawi
Treatment Facilities
On
July 14, 2012, GB Oncology and Imaging Group LTD (“GBOIG”) in partnership with the Company signed a letter of intent
agreement to collaborate with the Government of Malawi to assist in expanding the treatment of cancer, HIV/AIDS and other infectious
diseases.
In
December of 2014, the Government of Malawi completed an oncology clinic at the Queen Elizabeth Central Hospital in Blantyre, Malawi
for the treatment of cancer and infectious diseases. In 2015, the Company submitted protocols seeking permission from the College
of Medicine Research and Ethics Committee of Malawi (“COMREC”) to conduct two trials involving Lodonal™ in Malawi:
a.
|
The
first protocol, submitted jointly with The Jack Brewer Foundation (“JBF Worldwide”), received COMREC approval
on November 11, 2015. The protocol covers a 12-month trial for a “Single Visit Approach to Cervical Cancer Prevention.”
The approach is designed to deliver a preventive and simple procedure that can be performed in a clinical setting without
the use of a laboratory and to allow for immediate treatment of any precancerous lesions utilizing Wallach LL100 Cryosurgical
systems. The protocol provides for 50% of the patient group to be put on Lodonal™ to determine if the drug lowers the
number of opportunistic infections during the year, and if it can be shown that Lodonal™ increases CD4, CE8, NK and
T cell count, which would show that the incidence rates of opportunistic infection could decrease with Lodonal™ and
that Lodonal™ could be used as a prophylaxis to prevent substantial HIV-related morbidity in Malawi. COMREC approved
the trial in late 2016. Enrollment of study subjects began in late 2016, and the study commenced in January 2017. Due to the
fact that enrollment to date in the study has been low, we now expect to reach the target sample size only by the end of the
third quarter of 2017. The trial is ongoing with subjects recruited so far, but it cannot be completed until an acceptable
sample subject size is reached.
|
|
|
b.
|
The
second protocol, which has not yet been approved, covers a trial using Lodonal™ for the treatment of cancer. The Company
has put this trial on hold as it may not be required now that the Company has received approval in Nigeria for in addition
to the pending approval in Kenya and Senegal for Lodonal™ for the treatment of cancer.
|
Distribution
Agreements in Nigeria
Effective
November 9, 2012, the Company signed an exclusive Distribution Agreement with G-Ex Technologies/St. Maris Pharma and GB
Pharma Holdings, LLC for the Federal Republic of Nigeria. The parties have been unable to perform under the agreement because
a certificate of free sale was not obtained by the Company until November of 2013, and no extension has been granted.
In
October 2013, the Company announced the signing of a Distribution Agreement with AHAR Pharma, a Nigerian company, to market Lodonal™,
in Nigeria for the treatment of autoimmune diseases and cancer. AHAR intends to distribute Lodonal™ through a local distributor
network, an Internet client base and directly to hospitals, pharmacists and doctors in Nigeria. The agreement expires in December
2018. Under the agreement, the Company is obligated to provide delivery of an initial supply of between 1 million and 1.5 million
doses of Lodonal™ product to cover AHAR Pharma’s first-year purchase commitment.
In
August 2015, the Company announced the signing of a letter of intent with GB Pharma/AHAR and Fidson Healthcare Plc., in terms
of which Fidson will promote Lodonal
TM
upon execution of a definitive agreement between the companies and receipt required
regulatory approvals to distribute Lodonal
TM
in Nigeria.
In
May 2017, the Company received approval from the National Agency for Food and Drug Administration and Control of Nigeria (“NAFDAC”)
to market and distribute Lodonal
TM
in Nigeria. The approval is for a one-day Immune System Regulator for the management
of HIV/AIDS, which is based on the results of the Company’s 90-day bridging trial in Nigeria.
Agreements
in Kenya
In
March 2017, the Company signed a Memorandum of Understanding (“MOU”) for distribution of Lodonal™ in Kenya.
The MOU is a three-way distribution agreement between the Company, Kenya-based Omaera Pharmaceuticals Limited, a leading Kenyan
pharmaceutical importer and distributor, and GB Pharma Holdings. The MOU sets forth standard terms and conditions for distributing
Lodonal™ in Kenya.
In
April 2017, the Company submitted a New Drug Application (“NDA”) to the Pharmacy and Poison Board (“PPB”)
in Kenya for Lodonal
TM
for the treatment of patients with HIV and cancer, both as a standalone treatment as well as
an adjunct treatment, and as an immunomodulator.
Agreements
with Hubei Qianjiang Pharmaceutical Company
On
October 18, 2012, the Company and Hubei Qianjiang Pharmaceutical Co., Ltd. (“Qianjiang Pharmaceutical”), signed a
Venture Cooperation Agreement on New Drug Methionine Enkephalin (the “Venture Agreement”) pursuant to which Qianjiang
Pharmaceutical acquired an exclusive license for the production of MENK in China. The Venture Agreement requires that Qianjiang
Pharmaceutical conduct drug research and pilot testing for MENK, organize pre-clinical studies, and apply for clinical trials
for MENK with the Chinese State Food and Drug Administration. Under the Venture Agreement, Qianjiang Pharmaceutical must open
a co-administration account for the development of MENK in China. Qianjiang Pharmaceutical must pay the Company, upon the marketing
of MENK products, a half-year amount equaling 6% of its gross sales from MENK of the preceding half year. The Company may cancel
the Venture Agreement if Qianjiang Pharmaceutical does not pay expenses for a period exceeding six months or does not commence
clinical trials within 12-months after receiving certain approvals. Qianjiang Pharmaceutical may cancel the Venture Agreement
if the Company fails to perform its obligations for a period of six months or the failure to receive approval of clinical trials
is due to the Company’s MENK technologies. The Venture Agreement was amended on February 24, 2013 to expand the clinical
trials from pancreatic to both pancreatic and liver cancer and amended on March 6, 2014 to require Qianjiang Pharmaceutical to
commence studies and clinical trials in China and place funds in the co-administration account.
On
August 6, 2014, the Company entered into a Supplementary Agreement on New Drug Methionine – Enkephalin Cooperation (the
“Amendment”) with Qianjiang Pharmaceutical, amending the Venture Agreement, as amended. The Company and Qianjiang
Pharmaceutical executed the Amendment to accelerate clinical trials in both the United States and China, and agreed to immediately
initiate three month Good Laboratory Practice (“GLP”) Toxicology Studies (rat and dog) within 30 days of signing the
Amendment. The Amendment requires that the GLP Toxicology Studies Trials are conducted in China in accordance with international
standards and standards acceptable to the FDA and that the studies include the following:
Exploratory
Toxicology (nGLP)
|
●
|
Dose
range finding studies
|
|
●
|
Different
species and methods of administration
|
|
●
|
Multiple
dosing regimens
|
|
●
|
Estimate
the response vs. dose given
|
Definitive
Toxicology (GLP)
|
●
|
Performed
in collaboration with Calvert Laboratories (USA) and MPI/Medicillon (China)
|
|
●
|
General
toxicology studies
|
|
●
|
Different
species and methods of administration
|
|
●
|
Immunogenicity
study with NHPs
|
Special
Toxicology Studies (planned)
Pursuant
to the Amendment, Qianjiang Pharmaceutical has made certain funds available from the co-administrative account opened by Qianjiang
Pharmaceutical under the Venture Agreement, in accordance with an approved budget and timeline set forth in the Amendment. A portion
of these funds are expected to be used by Cytocom to run PK and Dosing trials for MENK in the United States in 2016. The Amendment
requires Cytocom and Qianjiang Pharmaceutical to meet with the China State Food and Drug Administration to determine that PK and
Dosing Trials completed in the United States will be acceptable. All developments and trials run by Cytocom in the U.S. or the
European Union will be used for requesting registration approval in China.
In
February 2013, the Company signed a Strategic Framework Agreement for Cooperation with Qianjiang Pharmaceutical. Under the agreement,
the parties will work together to further the development of new products and conduct research and development on the Company’s
licensed patented technology. Specifically, the parties aim to co-invest to develop and market products focusing on HIV, cancer
and related autoimmune system therapies, develop co-ventured manufacturing facilities in China, and develop co-ventured distribution
of the developed products in China and Africa. The agreement does not have a definitive term, as each new agreement resulting
from the cooperation will set forth the material terms, including, but not limited to, fees, duration and termination therein.
In
December of 2016 Qianjiang Pharmaceutical completed the following documents:
Exploratory
Toxicology (nGLP)
|
●
|
Dose
range finding studies
|
|
●
|
Different
species and methods of administration
|
|
●
|
Multiple
dosing regimens
|
|
●
|
Estimate
the response vs. dose given
|
Definitive
Toxicology (GLP)
|
●
|
Performed
in collaboration with Calvert Laboratories (USA) and MPI/Medicillon (China)
|
|
●
|
General
toxicology studies
|
|
●
|
Different
species and methods of administration
|
|
●
|
Immunogenicity
study with NHPs
|
In
addition to the pharmacology and toxicology studies, Qianjiang Pharmaceutical and China Peptide completed the formulation and
CMC necessary to scale up manufacturing of MENK.
Contract
Manufacturing Agreements
On
May 16, 2016, the Company entered into an agreement with Complete Pharmacy and Medical Solutions, LLC (“CPMS”) to
compound, package and distribute the LDN tablets, capsules and/or creams in the United States. The initial term of the agreement
is three years, with the option to renew for an additional year. The agreement may be terminated by (i) mutual agreement, (ii)
in the event of a breach, provided however that if the Company terminates the agreement, the Company will be required to reimburse
CPMS for all unused packaging materials for the LDN, which unused packaging materials CPMS will provide to IMUN. If CPMS does
not receive and ship at least 1,000 orders (prescriptions) during the term of the agreement, the Company will be required to reimburse
CPMS for 100% of the “ramp up costs” (defined as all costs and expenses of labor and materials related to the testing,
and required FDA and other governmental documentation/approvals of test data) of providing and producing the LDN, even where the
Company cancels/terminates the agreement, which provision shall survive the cancellation/termination of the agreement.
On
October 25, 2016, the Company and Acromax Dominicana, SA (“Acromax”) entered into a contract for manufacturing of
LDN tablets, capsules and/or creams (“Agreement”). In accordance with the terms and conditions of the Agreement, Acromax
will obtain all necessary licenses and permits to carry out the manufacturing and packaging of LDN in exchange for a fixed fee
per tablet plus an additional fee for packaging, shipping and customs clearance. The Agreement has an initial term of five years
unless terminated by either party in accordance with its terms.
In January
2017, Acromax obtained from the Ministry of Public Health and Social Assistance a Medications and Specialized Pharmaceuticals
Registration Certification for Lodonal
TM
, which allows for the manufacture and sale of Lodonal
TM
in the
Dominican Republic and for export. The Ministry also issued a Certificate of Pharmaceutical Product for Nigeria, Kenya, Senegal
and Malawi, which will allow for the export of Lodonal
TM
to those countries where the Company has drug and marketing
approval.
Operating
Leases
At
June 30, 2017, the Company was a party to an agreement to lease office space in Orlando, Florida. Rent expense for the quarters
ended June 30, 2017 and 2016 was $4,221 and $4,011, respectively
Legal
Proceedings
None.
11.
Subsequent Events
The
Company issued 2,848,187 shares of common stock between June 30, 2017 and August 12, 2017, of which 560,617 shares were for a
cashless exercise of a warrant, 2,287,570 shares were for debt conversions and settlements.
Between
July 1, 2017 and August 11, 2017, the company received $50,000 in debt financing and $50,000 in equity.
As
of August 12, 2017, the Company had outstanding 335,538,005 shares of common stock.