Indicate by check mark if the registrant is
a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes
¨
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
¨
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
¨
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 of this chapter) during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such files). Yes
x
No
¨
Indicate by check mark if disclosure of delinquent
filers pursuant to Item 405 of Regulation S-K 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.
¨
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.
¨
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
¨
No
x
The registrant met the “accelerated filer” requirements
as of the end of its 2017 fiscal year pursuant to Rule 12b-2 of the Securities Exchange Act of 1934, as amended. However, pursuant
to Rule 12b-2 and SEC Release No. 33-8876, the registrant (as a smaller reporting company transitioning to the larger reporting
company system based on its public float as of March 31, 2017) is not required to satisfy the larger reporting company requirements
until its first quarterly report on Form 10-Q for the 2018 fiscal year and thus is eligible to check the “Smaller Reporting
Company” box on the cover of this Form 10-K.
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act). Yes
¨
No
x
The aggregate market value of the registrant’s voting and
non-voting common equity held by non-affiliates as of the last business day of the registrant’s most recently completed second
fiscal quarter, computed by reference to the average of the bid and asked price of such common equity, was approximately $78,000,000.
For purposes of this calculation, it has been assumed that shares of common stock held by each director, each officer and each
person who owns 10% or more of the registrant’s outstanding common stock are held by affiliates.
As of November 14, 2017, 153,935,130 shares of the registrant’s
common stock were outstanding.
As used in this Annual Report on Form 10-K unless otherwise indicated,
the “
Company
”, “
we
”, “
us
”, “
our
”, and “
Arch
”
refer to Arch Therapeutics, Inc. and its consolidated subsidiary, Arch Biosurgery, Inc.
PART I
ITEM 1. BUSINESS
The following discussion should be read in conjunction with our
consolidated financial statements and the related notes and other financial information included in this Annual Report on Form
10-K.
Corporate Overview
Arch Therapeutics, Inc., (together with its subsidiary, the “
Company
”
or “
Arch
”) was incorporated under the laws of the State of Nevada on September 16, 2009, under the name “Almah,
Inc.” to pursue the business of distributing automobile spare parts online. Effective June 26, 2013, the Company completed
a merger (the “
Merger
”) with Arch Biosurgery, Inc. (formerly known as Arch Therapeutics, Inc.), a Massachusetts
corporation (“
ABS
”), and Arch Acquisition Corporation (“
Merger Sub
”), the Company’s
wholly owned subsidiary formed for the purpose of the transaction, pursuant to which Merger Sub merged with and into ABS and ABS
thereby became the wholly owned subsidiary of the Company. As a result of the acquisition of ABS, the Company abandoned its prior
business plan and changed its operations to the business of a biotechnology company. Our principal offices are located in Framingham,
Massachusetts.
For financial reporting purposes, the Merger represented a “reverse
merger”. ABS was deemed to be the accounting acquirer in the transaction and the predecessor of Arch. Consequently, the accumulated
deficit and the historical operations that are reflected in the Company’s consolidated financial statements prior to the
Merger are those of ABS. All share information has been restated to reflect the effects of the Merger. The Company’s financial
information has been consolidated with that of ABS after consummation of the Merger on June 26, 2013, and the historical financial
statements of the Company before the Merger have been replaced with the historical financial statements of ABS before the Merger
in this report.
ABS was incorporated under the laws of the Commonwealth of Massachusetts
on March 6, 2006 as Clear Nano Solutions, Inc. On April 7, 2008, ABS changed its name from Clear Nano Solutions, Inc. to Arch Therapeutics,
Inc. Effective upon the closing of the Merger, ABS changed its name from Arch Therapeutics, Inc. to Arch Biosurgery, Inc.
Our Current Business
We are a biotechnology company in the development stage. We have
generated no revenues to date and are devoting substantially all of our operational efforts to the development of our core technology.
We are developing a novel approach to stop bleeding (“
hemostasis
”), control leaking (“
sealant
”)
and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling
barrier technology platform with the goal of making care faster and safer for patients. We believe our technology could support
an innovative platform of potential products in the field of stasis and barrier applications. Our plan and business model is to
develop products that apply that core technology for use with bodily fluids and tissues.
To date, the Company has principally raised capital through borrowings
and the issuance of convertible debt and units consisting of its common stock, par value $0.001 per share (“
Common Stock
”),
and warrants. The Company expects to incur substantial expenses for the foreseeable future relating to the research, development,
clinical trials, and commercialization of its potential products. As of November 14, 2017, we believe that our current cash on
hand will meet our anticipated cash requirements into the fourth quarter of Fiscal 2018. The Company will be required to raise
additional capital in order to continue to fund operations. There can be no assurance that the Company will be successful in securing
additional resources when needed on terms acceptable to the Company, if at all. Therefore, there exists substantial doubt about
the Company’s ability to continue as a going concern.
Our Core Technology
Our flagship development stage product candidates, known collectively
as the AC5 Devices™ (which we sometimes refer to as “
AC5™
”, “
AC5™ Topical Gel
”,
“
AC5 Surgical Hemostatic Device™
”, “
AC5 Surgical Hemostat™
”, “
AC5 Topical
Hemostatic Device™
”, or “
AC5 Topical Hemostat™
”), are being designed to achieve hemostasis
during surgical, wound and interventional care. They rely on our self-assembling peptide (“
SAP
”) technology
and are being designed to achieve hemostasis in skin wounds and in minimally invasive and open surgical procedures. We intend
to develop other product candidates based on our technology platform for use in a range of indications.
AC5 is being designed as a product containing synthetic biocompatible
peptides comprising L amino acids, commonly referred to as naturally occurring amino acids. When applied to a wound, AC5 intercalates
into the interstices of the connective tissue where it self-assembles into a physical, mechanical nanoscale structure that provides
a barrier to leaking substances, such as blood. AC5 may be applied directly as a liquid, which we believe will make it user-friendly
and able to conform to irregular wound geometry. Additionally, AC5 does not possess sticky or glue-like handling characteristics,
which we believe will enhance its utility in several settings, including minimally invasive surgical procedures. Further, in certain
settings, AC5 lends itself to a concept that we call Crystal Clear Surgery™; the transparency and physical properties of
AC5 may enable a surgeon to operate through it in order to maintain a clearer field of vision and prophylactically stop or lessen
bleeding as it starts.
We believe that the results of early data from preclinical tests
have shown quick and effective hemostasis with the use of AC5 relative to that reported with other types of hemostatic agents,
and that time to hemostasis is comparable among test subjects regardless of whether such test subject had or had not been treated
with therapeutic doses of anticoagulant or antiplatelet medications, commonly called “blood thinners”. Based on testing
results to date, we believe that AC5 is biocompatible. Arch Therapeutics’ (Arch) technology has demonstrated hemostasis in
liver and other organs in in vivo surgical models, including durable hemostasis within 15 seconds. SAP compositions have been tested
in small animal organs (i.e. liver, skin, muscle, brain, eye, spine, spleen, arteries and veins). In mammalian vision models (severed
hamster optic tract) and in our ocular tissue pilot studies, SAPs demonstrated biocompatibility and the ability to rapidly and
reliably stop bleeding) and limit inflammation.
We have devoted much of our operational effort to date to the research
and development of our core technology, including selecting our initial product composition, conducting initial safety and other
related tests, conducting an initial human trial for safety and performance of AC5, developing methods for scale-up, reproducibility,
manufacturing and formulation, and developing and protecting the intellectual property rights underlying our technology platform.
Manufacturing method and formulation optimization are important parts of peptide development. Manufacturing and formulation optimization
for our product candidates has been and continues to be done with extensive collaboration among our team and partners. The processes
are focused on optimizing traditional product parameters to target specifications covering performance, biocompatibility, physical
appearance, stability, and handling characteristics, among others. We and our partners intend to monitor manufacturing processes
and formulation methods closely, as success or failure in both setting and realizing appropriate specifications may directly impact
our ability to conduct preclinical and clinical trials and our subsequent commercialization timelines.
Clinical Development
In October 2016, we reported that we completed a single-center,
randomized, single-blind prospective clinical study (NCT 02704104) of the AC5 Topical Hemostatic Device in skin lesion patients
with bleeding wounds. This was the first study assessing the safety and performance of AC5 in humans. The objectives of the study
were to evaluate the safety and performance of AC5 in patients scheduled to undergo excision of skin lesions on their trunk or
upper limbs. The primary endpoint was safety throughout the surgical procedure and until the end of a 30-day follow-up period post
procedure. Safety of the clinical investigation device was determined by monitoring for treatment related adverse events. The primary
objective was met, as the safety outcomes of both the AC5 treatment group and the control group were similar. No serious adverse
events were reported.
A secondary endpoint was performance as assessed by time to hemostasis.
The median time to hemostasis of wounds in the AC5 treatment group was 41% faster than for those in the control group. This result
was statistically significant (p < 0.001, Wilcoxon signed rank test). An additional secondary endpoint of healing of treated
wounds was assessed as measured by the ASEPSIS wound score at Days 7 and 30. There was no evidence, at either follow-up day, of
an adverse effect of AC5 treatment on the wound ASEPSIS score. The ASEPSIS score did not appear to be compromised, as the majority
of patients had an ASEPSIS score of 0 in both wounds at Days 7 and 30. All AC5-treated wounds healed satisfactorily as per wound
healing scoring criteria.
The clinical study enrolled 46 patients, including 10 who were taking
antiplatelet monotherapy. Each patient had bleeding wounds created as a result of the excision of at least two skin lesions under
local anesthetic in the same setting. On a randomized basis, one lesion received AC5 and the other(s) received a control treatment
consisting of standard therapy plus a sham. Each subject was followed-up for safety assessment both on Day 7 and again on Day 30,
which marked the end of the subject's participation in the clinical study.
Additionally, the clinical study indicated that AC5 shortened time
to hemostasis ("TTH") versus a control whether or not patients were taking antiplatelet therapy, suggesting that AC5
performance is not affected by antiplatelet therapy. The reduced median TTH of the AC5 treated wounds versus the control wounds
was statistically significant for both the overall group of 46 patients (p<0.001) and for the subgroup of 10 patients on antiplatelet
therapy (p=0.005). Further, the median TTH for wounds treated with AC5 was less than 30 seconds for both the overall study group
and for the subset of patients taking antiplatelet therapy.
Preclinical Development
Previously, we completed the components of the planned preclinical
program for AC5 that were required before we started our first human safety and performance trial, which was completed in 2016.
We are focused on scale-up of selected manufacturing methods and formulation optimization. In parallel, we are continuing to conduct
further
in vivo
and
in vitro
tests, while additional testing will continue after completion of manufacturing scale-up
and formulation optimization steps and the clinical trial. Self-assembling peptide manufacturing and formulation optimization are
challenging, and any delays could negatively impact anticipated clinical trial and subsequent commercialization timelines. In order
to market and sell AC5 and other Arch planned products, successful human clinical trials, additional testing, and regulatory approvals
and certifications will be required. A co-founding inventor of certain of our technology, Dr. Rutledge Ellis-Behnke, performed
a significant portion of the early preclinical animal experimentation conducted on our technology. Some of the most significant
findings from Dr. Ellis-Behnke’s studies have been published. Additionally, through collaboration with the National University
of Ireland system, preclinical bench-top and animal studies have been performed in Dublin and Cork, Ireland. As a continuation
of our commitment to our product development we entered into a collaboration agreement with National University of Ireland Galway
(“
NUIG
”) in Galway, Ireland on May 28, 2015 (the “
Project Agreement
”). Pursuant to the Project
Agreement,
NUIG will provide, via
the CÚRAM Centre for Research in Medical
Devices (“
CÚRAM
”), which is a major national research center headquartered at NUIG established in January
2015 as part of a six-year grant from the Irish government,
personnel, infrastructure support
and grant funding in connection with a research program intended to facilitate the continued development of the Company’s
core technology (the “
Project
”). Under the terms of the Project
Agreement, which has a term that will end upon the earlier of the completion of the Project the sixth anniversary of the execution
date of the Project Agreement, or termination by either party, we may contribute up to a maximum of two hundred and fifty thousand
euro (€250,000) to the Project per year, and NUIG will match such funds at a 2:1 ratio using funds allocated to NUIG by Science
Foundation Ireland’s (“
SFI
”) Research Centres Programme.
In addition, while NUIG will initially retain ownership of all intellectual property developed in connection with the Project (collectively,
“
Project IP
”), any such Project IP that was either based on or
derived from our existing intellectual property (“
Derivative IP
”)
will be assigned back to us for a nominal fee. For any Project IP that does not constitute Derivative IP (“
Non-Derivative
IP
”),
we will have a right of first negotiation for an exclusive license
to such Non-Derivative IP on customary terms for agreements of that nature including royalties on net sales in the low single-digits,
in each case subject to a grant-back to NUIG for research and academic purposes. We have also engaged, on a fee for service basis,
several private third party facilities in the United States and abroad to perform certain preclinical bench-top and animal studies,
which are often conducted with assistance from our scientific team, and we continue to engage third parties for such services as
needed and as appropriate.
In the preclinical animal tests conducted to date, AC5 has demonstrated
rapid average time to hemostasis (“
TTH
”) when applied to a range of animal tissues. Certain studies have tested
TTH when using AC5 during surgical procedures compared to TTH when using a control substance, a saline control substance, a control
peptide, and a cautery control substance during those same procedures. The results of those tests have shown a TTH of approximately
10 – 30 seconds when AC5 was applied, compared to a TTH ranging from 80 seconds to significantly more than 300 seconds when
various control substances were applied, depending on the nature of the control substance and procedure performed. In several studies
comparing AC5 to popular commercially available branded hemostatic agents (absorbable cellulose, flowable gelatin with and without
thrombin, and fibrin) applied to stop the bleeding from full thickness penetrating wounds surgically created in rat livers, AC5
achieved hemostasis in significantly less than 30 seconds, whereas the control products took from 50% to over 400% longer than
AC5 to achieve hemostasis.
Additionally, the preclinical tests that have been conducted to
date provide evidence that AC5 can stop bleeding in models of liver bleeding in animals that had been treated with therapeutic
amounts of anticoagulant and antiplatelet medications, commonly called “blood thinners.” In one preclinical study,
an independent third-party research group obtained positive data assessing the use of AC5 in animals that had been treated with
therapeutic doses of the antiplatelet medications Plavix® (clopidogrel) and aspirin, alone and in combination. The results
of the study were consistent with data obtained from two prior preclinical studies, in which AC5 quickly stopped bleeding from
surgical wounds created in rats following treatment with clinically relevant doses of the anticoagulant medication heparin. In
these studies, the average TTH after AC5 was applied to bleeding liver wounds of animals that had been medicated with anticoagulants
was comparable to the average TTH as measured in their non-anticoagulated counterparts. Similar results were obtained in independent
third-party studies assessing the use of AC5 in patients on the anticoagulant heparin and in patients on the anti-platelet medication,
ticagrelor (Brilinta® in the US, Brilique in Europe®.)
In preclinical tests conducted to date, AC5 has demonstrated biocompatibility
and normal healing of tissue treated with the product. Further, animals whose liver, spleen, femoral artery, eye or brain was treated
with AC5 have shown no ill effects. We believe that the peptide degrades into the amino acids from which it was originally synthesized,
which are molecules that already exist in large quantities in the human body.
Our current and planned near-term activities are focused on manufacturing
scale-up, formulation optimization, and other preclinical activities, and conducting further clinical trial testing of AC5. In
its first clinical study for safety and performance, AC5 was demonstrated to be safe and to reduced TTH in wounds versus controls.
Our clinical study also demonstrated that in a subgroup of 10 patients who were taking a prescribed antiplatelet medication, commonly
known as a blood thinner, such as aspirin, AC5 had similar effects.
Development and Commercialization Strategy
Our present business model is to operate with a relatively small
internal team of key personnel and engage third party service providers to conduct larger scale research, development and manufacturing
activities. Our internal team collectively has a broad range of expertise and experience working with and managing third party
vendors. This general approach enables us to use the services of third party entities, which are expert, in various aspects of
our operations, while preserving capital and efficiencies by avoiding certain internal scale-up costs and resource duplication.
Research and Development; Manufacturing
Use of Third Party Relationships
To date, we have engaged third party laboratory facilities run by
experts in the U.S. and abroad to perform both research and preclinical and clinical development activities. Those engagements
have assisted in our development of our primary product candidate, as well as our generation of appropriate analytical methods,
scale-up, and other procedures for use as a “blueprint” for third party manufacturers to produce the product on a larger
scale for purposes of further preclinical and clinical testing and ultimately, if required approvals are obtained, commercialization.
We have initiated the transition to traditional contract manufacturing
and related organizations. We have commenced relationships and work with manufacturers operating with the current good manufacturing
practices (“
cGMP
”) required by applicable regulatory agencies in order to scale up and produce formulation material
to be used for final preclinical testing and clinical trials.
Manufacturing Methods
We believe that the manufacturing methods used for a product, including
the type and source of ingredients and the burden of waste byproduct elimination, are important determinants of its opportunity
for profitability. Industry participants are keenly aware of the downsides of technologies that rely on expensive biotechnology
techniques and facilities for manufacture, onerous and expensive programs to eliminate complex materials, or ingredients that are
sourced from the complicated process of human or other animal plasma separation, since those products typically are expensive,
burdensome to produce, and at greater risk for failing regulatory oversight.
The manufacturing methods that we intend to use to produce AC5 and
other potential future product candidates rely on detailed, complex and difficult to manage synthetic organic chemistry processes.
Although use of those methods requires that we engage manufacturers that possess the expertise, skill and know-how involved with
those methods, the required equipment to use those methods is widely available. Furthermore, improvements in relevant synthetic
manufacturing techniques over the past decade have reduced their complexity and cost, while increasing large-scale cGMP capacity.
Moreover, our planned product candidates, including AC5, will be synthesized from naturally occurring ingredients that are not
sourced from humans or other animals, but do exist in their natural state in humans. That type of ingredient may be more likely
to be categorized as “generally recognized as safe”, or “
GRAS
”, by the U.S. Food and Drug Administration
(“
FDA
”).
Regulatory
Medical Device Classification
In February of 2015, we announced that The British Standards Institution
(“
BSI
”), a Notified Body (which is a private commercial entity designated by the national government of a European
Union (“
EU
”) member state as being competent to make independent judgments about whether a medical device complies
with applicable regulatory requirements) in the EU, confirmed that AC5 fulfills the definition of a medical device within the EU
and will be classified as such in consideration for CE mark designation. The FDA and other regulatory authorities or related bodies
separately determine the classification of AC5. The FDA also determined it to be a medical device. Generally, a product is a medical
device if it requires neither metabolic nor chemical activity to achieve the desired effect. Furthermore, a medical device can
achieve its desired effects without requiring a body (animal/human), whereas a drug or a biologic requires a body in order to operate.
The AC5 mechanism of assembly into a barrier can occur outside of a body and is accordingly consistent with the medical device
definition.
Medical devices in the EU and the U.S. are classified along a spectrum.
Class III status, which is the higher-level classification for devices compared to Classes II and I, involves additional procedures
and regulatory scrutiny of the product candidate to obtain approvals. AC5 could be regulated as either a Class III or a Class II
medical device in these jurisdictions, depending upon the application, subject to the process for obtaining a CE mark in the EU
and the premarketing authorization process in the U.S. It has been determined that our AC5™ Topical Gel used for external
wounds will be a Class II medical device.
Biocompatibility Tests and Clinical Trials
Before initiating our European or most other human clinical trials,
we are required to have completed the biocompatibility assessment of AC5. Standard required tests to assess biocompatibility, as
set forth in ISO 10993 issued by the International Organization for Standardization, may include:
|
·
|
in vitro blood compatibility;
|
|
·
|
in vitro Ames assay
(mutagenic activity);
|
|
·
|
irritation/intracutaneous
reactivity;
|
|
·
|
sensitization (allergenic
reaction);
|
|
·
|
implantation (performed
on devices that contact the body’s interior);
|
|
·
|
pyrogenicity (causing
fever or inflammation);
|
|
·
|
in vitro chromosome
aberration assay (structural chromosome changes).
|
We completed the biocompatibility studies required to initiate our
first human trial of AC5 in Western Europe. We will perform further biocompatibility testing that we deem necessary for additional
indications, classifications, jurisdictions, and/or as required by regulatory authorities.
On August 15, 2016, we announced that the AC5 Topical Hemostatic
Device met its primary and secondary endpoints in our first clinical trial for safety and performance. On October 31, 2016, the
Company further announced that additional analysis of the subgroup of 10 patients who were taking a prescribed antiplatelet medication,
commonly known as a blood thinner, such as aspirin, indicated that AC5 had similar effects for this subgroup. The Company plans
to include data from this trial, as well as data available from the U.S. in a CE mark application that we currently intend to submit
in 2018 and approval of which is required in order to market and commercialize AC5 as a medical device in Europe. We also expect
to use this data in support of additional U.S. regulatory filings.
We expect that we will pursue approvals for use of AC5 as a hemostatic
agent and wound care agent in surgical and dermatological settings, and we may also seek to obtain approvals for additional potential
indications for use of the product, which we may pursue either opportunistically or once initial regulatory approval for the product
is obtained.
Commercialization
Our commercialization plan for at least some of our product candidates
could entail entering into one or more collaboration agreements or strategic partnerships. Based on our general approach and strategy
of utilizing the expertise and resources of third party service providers and maintaining a relatively small internal team, we
currently expect that we may pursue some degree of strategic collaborations or partnerships with third parties, which could include
licensing arrangements, distribution and supply partnerships, engagement of external regulatory experts and/or marketing and sales
teams, among other types of potential relationships. We presently believe that certain relationships could improve our ability
to obtain regulatory approval for our product candidates and attain market acceptance for and profitable sales of those product
candidates, and that our current and planned activities and milestones relating to AC5 are well-aligned with the needs of the market
and potential partners and collaborators that may wish to enter or expand their presence in our target markets.
We envision the potential future customers in the marketplace for
AC5 and any other hemostatic or sealant agent we may pursue will include surgeons and other doctors, government agencies such as
the Department of Defense, hospital and operating room management and ambulance and other trauma specialists.
Plan of Operations
Our long-term business plan includes the following goals:
|
·
|
conducting required
biocompatibility studies and, subsequently, additional clinical trials on AC5 and related products;
|
|
·
|
expanding and maintaining
protection of our intellectual property portfolio;
|
|
·
|
developing appropriate
third party relationships to manufacture, distribute, market and otherwise commercialize AC5;
|
|
·
|
obtaining regulatory
approval or certification of AC5 and related products in the EU, the U.S., and other jurisdictions as we may determine;
|
|
·
|
continuing or developing
academic, scientific and institutional relationships to collaborate on product research and development; and
|
|
·
|
developing additional
product candidates in the hemostatic, sealant, and/or other fields.
|
In furtherance of our long-term business goals, we expect to continue
to focus on the following activities during the next twelve months:
|
·
|
seek additional funding
as required to support the milestones described previously and our operations generally;
|
|
·
|
work with our large
scale manufacturing partners to scale up production of product compliant with current good manufacturing practices (“cGMP”),
which activities will be ongoing as we seek to advance toward, enter into, and, if successful, subsequently increase commercialization
activities;
|
|
·
|
further clinical development
of our product platform;
|
|
·
|
pursue regulatory clearance for commercialization;
|
|
·
|
continue to expand and
enhance our financial and operational reporting and controls;
|
|
·
|
seek commercial partnerships;
|
|
·
|
expand and enhance our
intellectual property portfolio by filing new patent applications, obtaining allowances on currently filed patent applications,
and/or adding to our trade secrets in self-assembly, manufacturing, analytical methods and formulation, which activities will
be ongoing as we seek to expand our product candidate portfolio;
|
|
·
|
obtain regulatory input into subsequent clinical trial designs;
|
|
·
|
assess our self-assembling
peptide platforms in order to identify and select product candidates for advancement into development.
|
In addition to capital required for operating expenses,
depending upon additional input from EU and US regulatory authorities, as well as the potential for additional regulatory
filings and approvals during the next 2 years, additional capital, may be required.
The estimated capital requirements potentially could increase significantly
if a number of risks relating to conducting these activities were to occur, including without limitation those set forth under
the heading “
RISK FACTORS
” in this filing. We anticipate that our operating and other expenses will continue
to increase as we continue to implement our business plan and pursue and achieve these goals. After giving effect to the funds
received in past equity and debt financings and assuming our use of that funding at the rate we presently anticipate, as of November
14, 2017, we believe that our current cash on hand will meet our anticipated cash requirements into the fourth quarter of Fiscal
2018. We could spend our financial resources much faster than we expect, in which case our current funds may not be sufficient to
operate our business for the entire duration of that period.
We have no commitments for any future capital. As indicated above,
we will require significant additional financing to fund our planned operations, including further research and development relating
to AC5, seeking regulatory approval of that or any other product we may choose to develop, commercializing any product for which
we are able to obtain regulatory approval or certification, seeking to license or acquire new assets or business, and maintaining
our intellectual property rights, pursuing new technologies and for financing the investor relations and incremental administrative
costs associated with being a public corporation. We do not presently have, nor do we expect in the near future to have, revenue
to fund our business from operations, and we will need to obtain all of our necessary funding from external sources for the foreseeable
future. We may not be able to obtain additional financing on commercially reasonable or acceptable terms when needed, or at all.
If we cannot raise the money that we need in order to continue to develop our business, we will be forced to delay, scale back
or eliminate some or all of our proposed operations. If any of these were to occur, there is a substantial risk that our business
would fail and our stockholders could lose all of their investment.
Since inception, we have funded our operations primarily through
debt borrowings and the issuance of convertible debt and units consisting of Common Stock and warrants, and we may continue to
seek to do so in the future. If we obtain additional financing by issuing equity securities, our existing stockholders’ ownership
will be diluted. The terms of securities we may issue in future capital-raising transactions may be more favorable for our new
investors. Further, newly issued securities may include preferences, superior voting rights and the issuance of warrants or other
derivative securities, which may have additional dilutive effects. If we obtain additional financing by incurring debt, we may
become subject to significant limitations and restrictions on our operations pursuant to the terms of any loan or credit agreement
governing the debt. Further, obtaining any loan, assuming a loan would be available when needed on acceptable terms, would increase
our liabilities and future cash commitments. We may also seek funding from additional collaboration or licensing arrangements in
the future, which may require that we relinquish potentially valuable rights to our product candidates or proprietary technologies
or grant licenses on terms that are not favorable to us. Moreover, regardless of the manner in which we seek to raise capital,
we may incur substantial costs in those pursuits, including investment-banking fees, legal fees, accounting fees, printing and
distribution expenses and other related costs.
Industry and Competition
Arch is developing technology for surgery and trauma care applications.
Planned products include, among others, barriers for both bleeding tissues and leaking fluids that create an environment permissive
to normal healing. The initial focus has been on procedures and surgeries, with plans to follow with trauma applications. The initial
clinical trial assessed AC5’s use in an external application, while internal human studies are intended to follow. Our intent
is to provide a product set with broad utility and relatively few constraints based on bleeding, leakage, and wound type. Features
of the technology highlight its potential utility in a range of settings, including traditional open procedures and the often more
challenging minimally invasive surgeries.
According to a 2012 report produced by MedMarket Diligence, LLC,
approximately 114 million surgical and procedure-based wounds occur annually worldwide, including 36 million from surgery in the
U.S. Since the early days of modern minimally invasive surgery in the 1990s, the percent of surgeries performed minimally invasively
has increased significantly such that it is now widespread and common. Minimally invasive surgery is often called laparoscopic
surgery, although there are additional types. Minimally invasive surgical procedures often present the surgeon with fewer margins
for potential error and less capacity to deal with certain risks, such as excessive bleeding, without converting the surgery to
a traditional open procedure. We believe that the performance and safety of both minimally invasive and traditional surgeries and
other procedures could benefit from newer hemostatic agents and sealants, because surgical and trauma patients are at significant
risk for morbidity and mortality from bleeding and/or leaking body fluid.
Additional trends that support a demand for hemostatic and sealant
products include the following:
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overall procedure volume
growth;
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ambulatory same day
surgery volume growth;
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minimally invasive surgery
procedure volume growth;
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efforts to reduce operating
room time; and
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increased use of anticoagulants,
which predispose patients to bleeding.
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As a result of this demand, use of hemostatic agents and sealants
is increasing. According to a 2015 MedMarket Diligence report, the market for these products achieved approximately $4.2 billion
in worldwide sales in 2015 and is projected to reach $4.8 billion in 2017 and surpass $7.5 billion in 2022. Approximately three
quarter of those sales are for hemostats, which are currently growing faster than sealants, as defined in the data survey. However,
we believe that due to a currently poorly met need and pent up demand, the projected growth rate for sealants could become greater
than that for hemostats once additional products become available.
In spite of the large size of the market for these products, many
available hemostatic agents and sealants possess a combination of limitations, including slow onset of action, general unreliability,
user-unfriendliness, and risk for adverse effects, such as healing problems, adhesion formation, infection and other safety concerns.
Many of the deficiencies of currently available hemostatic agents and sealants are comparable to those of their earlier-generation
counterparts, as revolutionary advances in underlying technologies have been elusive.
In the course of developing AC5, we engaged commercial strategy
and marketing consultants and communicated directly with care providers to understand the needs of potential customers and to assess
product feature preferences. As we expected, better efficacy and reliability were identified as product features important to those
customers, and we discovered that other product features are important to achieving broad market acceptance. Surgeons, operating
room managers, sales representatives for currently available hemostatic products, and hospital decision-makers identified a number
of desirable characteristics for a hemostatic agent, which we carefully consider while developing AC5. These features include that
a product is:
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easily handled and applied;
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able to promote a clear
field of vision and not obstruct view;
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non-viscous and flowable;
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non-sticky (to tissue
or equipment);
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able to permit normal
healing;
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indifferent to status
of coagulation cascade or “blood thinning” drugs;
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not sourced from human
or other animal blood or tissue components.
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We anticipate that AC5 will meet these particular market demands,
and we anticipate its use in minimally invasive or laparoscopic surgery as well as open surgical procedures. While open procedures
represents the more established market for hemostatic agents, the number of surgeries performed by minimally invasive techniques,
including laparoscopic surgery, has been growing over the past two decades and is significant. Less invasive laparoscopic procedures
tend to result in shorter recovery times, faster discharges, less scarring, less pain and less need for pain medications. Many
of the hemostasis products currently available do not possess certain features and handling characteristics that are ideal for
use in a laparoscopic setting. For instance, many available products are difficult to use laparoscopically because they tend to
be sticky, powdery, fabric-based or are otherwise difficult to control and/or insert into the small tubes used during many laparoscopic
procedures. We believe that the novel features and differentiating characteristics of AC5 will make it more suitable for laparoscopic
surgeries than many or most presently available alternatives.
Further, available data indicates that there may be increased pressure
to perform more complex surgeries at reduced costs, including conducting operations in less expensive outpatient settings. Although
accurate current statistics are difficult to obtain, a National Health Statistics Report from 2006 and updated in 2009 indicates
that outpatient surgery volume was increasing by approximately 5% annually, and a 2009 report covering U.S. surgical procedures
suggests that inpatient surgery volume was declining 1% per year. We believe that a motivating factor of this trend may be the
increased costs associated with hospital inpatient procedures performed in operating rooms, which, according to MedMarket Diligence,
have been estimated to cost between $2,000 and $10,000 per hour. These costs likely motivate increased operating room throughput
and increased volume of procedures performed in outpatient settings. Both of those trends highlight the need for highly effective
hemostatic agents and sealants that can decrease operating room time for inpatient procedures and help to increase the safety of
performing more types of procedures in less expensive outpatient settings.
Participants in the hemostatic and sealant market currently include
large companies, such as Johnson & Johnson and its affiliated companies, C. R. Bard, Inc., Baxter International Inc., Mallinckrodt
plc, as well as various smaller companies. Certain companies in other sectors, such as pharmaceuticals, wound care, and orthopedics,
among others, are also interested in these markets.
Commercially available products in the hemostasis field with which
we would expect AC5 to compete if it obtains required regulatory approvals can cost between $50 and $500 per procedure, with the
higher value added products generally priced at the upper end of that range. Production costs of many of those products are significant,
as they may require biotechnology or plasma separation technologies to manufacture, and they may require ingredients or other materials
that are expensive to obtain. We believe that, assuming receipt of required regulatory approvals, AC5 will be well positioned to
compete against currently available products as a result of its broad applicability in various types of surgical settings and its
features that address drawbacks seen in many available hemostatic agents. Furthermore, our planned use of a manufacturing method
that we expect will be cost-effective compared to methods used to manufacture many currently available hemostatic products could
enable any future sales to be made at competitive price points within the market range
Potential Disadvantages of AC5 Compared to the Competition
Some potential disadvantages of AC5 compared to the hemostatic agents
currently on the market with which we would expect AC5 to compete if it obtains required regulatory approvals are as follows:
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The favorable handling
characteristics of AC5 are the result of its non-sticky and non-glue-like nature. However, if a surgeon or healthcare provider
requires a product to adhere tissues together, or provide similar glue-like action, then AC5 in its current form would not achieve
that effect.
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While we project that
AC5 will be relatively economical to manufacture at scale, it may not be able to compete from a price perspective with inexpensive
means to stop bleeding, such as application of pressure or use of bandages or other inexpensive hemostatic agents.
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Research and Development Expenditures
Our research and development expenses to date have primarily included
labor and third party consulting costs to develop our core technology and AC5. Research and development expense during the year
ended September 30, 2017 was $2,094,795, an increase of $411,496 compared to $1,683,299 for the year ended September 30, 2016.
We expect our research and development activities and expenses to increase significantly as we execute on our business plan and
commence additional clinical trials.
Regulation by the FDA and Similar Foreign Agencies
Our research, development and clinical programs, as well as our
manufacturing and marketing operations that may be performed by us or third party service providers on our behalf, are subject
to extensive regulation in the U.S. and other countries. Most notably, we believe that AC5 will be subject to regulation as a medical
device under the U.S. Food Drug and Cosmetic Act (the “
FDCA
”) as implemented and enforced by the FDA and equivalent
regulations enforced by foreign agencies in any other countries in which we desire to pursue commercialization. The FDA and its
foreign counterparts generally govern the following activities that we do or will perform or that will be performed on our behalf,
as well as potentially additional activities, to ensure that products we may manufacture, promote and distribute domestically or
export internationally are safe and effective for their intended uses:
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product design, preclinical
and clinical development and manufacture;
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product premarket clearance
and approval;
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product safety, testing,
labeling and storage;
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record keeping procedures;
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product marketing, sales
and distribution; and
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post-marketing surveillance,
complaint handling, medical device reporting, reporting of deaths, serious injuries or device malfunctions and repair or recall
of products.
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Pre-Marketing Regulation by the U.S. FDA
Medical Device Classification
As described previously, we expect that AC5 will be classified as
a medical device because its primary desired activity does not depend on metabolic or chemical activity in a body. The FDA classifies
medical devices into one of the following three classes on the basis of the amount of risk associated with the medical device and
the controls deemed necessary to reasonably ensure their safety and effectiveness:
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Class I, requiring general
controls, including labeling, device listing, reporting and, for some products, adherence to good manufacturing practices through
the FDA’s quality system regulations and pre-market notification;
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Class II, requiring
general controls and special controls, which may include performance standards and post-market surveillance; or
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Class III, requiring
general controls and approval of a premarket approval application (“
PMA
”), which may include post-market approval
conditions and post-market surveillance.
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Class III devices are those that are deemed by the FDA to pose the
greatest risks, such as life-sustaining, life-supporting or implantable devices, or that have a new intended use or use advanced
technology that is not substantially equivalent to that of a legally marketed device. As a result of the intended use of AC5 and
the novel technology on which is it based, we further anticipate that AC5 could be regulated as either a Class III or a Class II
medical device in these jurisdictions, depending upon the application.
US Regulatory Approval Process
Products that are regulated as medical devices and that require
review by the FDA are subject to either a premarket notification, also known as a 510(k), which must be submitted to the FDA for
clearance, or a PMA application, which the FDA must approve prior to marketing in the U.S. The FDA will ultimately determine the
appropriate regulatory path.
We believe that the products we are currently pursuing for
internal use will require a PMA approval prior to commercialization. However, we believe that we may commercialize an initial
product for external use after clearance through the 510(k) process. On July 25, 2017, we announced that we had made a 510(k)
submission to FDA for our AC5™ Topical Gel. If our 510(k) application is cleared by the FDA, it is expected that the
AC5™ Topical Gel will be used for external wounds.
To obtain 510(k) marketing clearance for a medical device, an applicant
must submit a premarket notification application to the FDA demonstrating that the device is "substantially equivalent"
to a predicate device, which is typically a legally marketed Class II device in the United States. A device is substantially equivalent
to a predicate device if it has the same intended use and (i) the same technological characteristics, or (ii) has different technological
characteristics and the information submitted demonstrates that the device is as safe and effective as a legally marketed device
and does not raise different questions of safety or effectiveness. In some cases, the submission must include data from human clinical
studies. Marketing may commence when the FDA issues a clearance letter finding substantial equivalence.
A PMA must be submitted to the FDA if a device cannot be cleared
through another approval process or is not otherwise exempt from the FDA’s premarket clearance and approval requirements.
A PMA is required for most Class III medical devices. A PMA must generally be supported by extensive data, including without limitation
technical, preclinical, clinical trial, manufacturing and labeling data, to demonstrate to the FDA’s satisfaction the safety
and efficacy of the device for its intended use. During the review period, the FDA will typically request additional information
or clarification of the information previously provided. Also, an advisory panel of experts from outside the FDA may be convened
to review and evaluate the PMA and provide recommendations to the FDA as to the approvability of the device, although the FDA may
or may not accept any such panel’s recommendation. In addition, the FDA will generally conduct a pre-approval inspection
of the manufacturing facility or facilities involved with producing the device to ensure compliance with the cGMP regulations.
Upon approval of a PMA, the FDA may require that certain conditions of approval, such as conducting a post-market approval clinical
trial, be met.
The PMA approval process can be lengthy and expensive and requires
an applicant to demonstrate the safety and efficacy of the device based, in part, on data obtained from clinical trials. The PMA
process is estimated to take from one to three years or longer, from the time the PMA application is submitted to the FDA until
an approval is obtained.
Further, if post-approval modifications are made that affect the
safety or efficacy of the device, including, for example, certain types of modifications to the device’s indication for use,
manufacturing process, labeling or design, then new PMAs or PMA supplements would be required. PMA supplements often require submission
of the same type of information as a PMA, except that the supplement is typically limited to information needed to support the
changes from the device covered by the original PMA and accordingly may not require as extensive clinical and other data.
We have not submitted to the FDA a PMA or commenced the required
clinical trials for an internal use product, and we have not submitted a premarket notification. Even if we conduct successful
preclinical and clinical studies and submit a PMA for an approval or premarket application for clearance, the FDA may not permit
commercialization of AC5 for the desired internal use indications, on a timely basis, or at all. Our inability to achieve regulatory
approval for AC5 in the U.S. for an internal use product, a large market for hemostatic products, would materially adversely affect
our ability to grow our business.
Clinical Trials
Obtaining PMA approval requires the completion of human clinical
trials that produce successful results demonstrating the safety and efficacy of the product. Clinical trials for a Class III medical
device typically require an application for an investigational device exemption (“
IDE
”), which would need to
be approved in advance by the FDA for a specified number of patients and study sites. Human clinical trials are subject to extensive
monitoring, recordkeeping and reporting requirements, and must be conducted under the oversight of an institutional review board
(“
IRB
”) for the relevant clinical trial sites and comply with applicable FDA regulations, including those relating
to good clinical practices (“
GCP
”).
In order to complete a clinical trial, we are required to enroll
a sufficient number of patients to conduct the trial after obtaining each patient’s informed consent in a form and substance
that complies with both FDA requirements and state and federal privacy and human subject protection regulations. Many factors could
lead to delays or inefficiencies in conducting clinical trials, some of which are discussed under the heading “
RISK FACTORS
”
in this Annual Report on Form 10-K. Further, we, the FDA or the IRB could suspend a clinical trial at any time for various reasons,
including a belief that the risks to the subjects of the trial outweigh the anticipated benefits. Even if a trial is completed,
the results of clinical testing may not adequately demonstrate the safety and efficacy of the device or may otherwise not be sufficient
to obtain FDA clearance or approval to market the product in the U.S.
On December 16, 2015, we announced that we had received clearance
from a regulatory authority in Western Europe to initiate a human clinical trial to assess the safety and performance of AC5 in
humans. The initial patient was treated in the first quarter of 2016 and on June 6, 2016, we announced we had completed patient
enrollment in this study. On August 15, 2016, we announced that the AC5 Topical Hemostatic Device met its primary and secondary
endpoints in our first clinical trial. On October 31, 2016, the Company announced that additional analysis of the subgroup of 10
patients who were taking a prescribed antiplatelet medication, commonly known as a blood thinner, such as aspirin, indicated that
AC5 had similar effects for this patient population.
Pre-Marketing Regulation in the EU
Medical Device Classification
Similar to the U.S., the EU recognizes different classes of medical
devices. The EU recognizes Class I, Class IIa, Class IIb or Class III medical devices, with the classification determination depending
on the amount of potential risk to the patient associated with use of the medical device. Classification involves rules found in
the EU’s Medical Device Directive. Key questions of relevance include the degree of the device’s contact with the patient,
invasiveness, active nature, and indications for use. The medical device classes recognized in the EU are as follows:
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Class I, which are considered
low risk devices, such as wheelchairs and stethoscopes, and require pre-market notification prior to placing the devices onto
the EU market;
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Class IIa, which are
considered low-medium risk devices and require certification by a Notified Body;
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Class IIb, which are
considered medium-high risk devices and require certification by a Notified Body; and
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Class III, which are
considered high-risk devices and require certification by a Notified Body.
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In February of 2015, we announced that BSI confirmed that AC5 fulfills
the definition of a medical device within the EU and will be classified as such in consideration for CE mark designation. We anticipate
that AC5 could be regulated as either a Class III or a Class II medical device in these jurisdictions, depending upon the application.
CE Mark Approval Process
Approval Process
The EU has adopted numerous directives and standards regulating
the design, manufacture, clinical trials, labeling, and adverse event reporting for medical devices. Recently, the EU has revised
its rules and regulations and have implemented increasingly stringent requirements. In addition, each EU member state has implemented
legislation applying these directives and standards at a national level. Many countries outside of the EU have also voluntarily
adopted laws and regulations that mirror those of the EU with respect to medical devices, potentially increasing the time and cost
necessary to potentially achieve an approval.
Under applicable EU medical device directives, a CE mark is a symbol
placed on a product that declares the product’s compliance with the essential requirements of applicable EU health, safety
and environmental protection legislation. In order to receive a CE mark for a product candidate, the company producing the product
candidate must select a country in which to apply. Each country in the EU has one competent authority (“
CA
”)
that implements the national regulations by interpreting the EU directives. CAs also designate and regulate Notified Bodies. An
assessment by a Notified Body in the selected country within the EU is required in order to commercially distribute the device.
In addition, compliance with ISO 13485 issued by the International Organization for Standardization, among other standards, establishes
the presumption of conformity with the essential requirements for CE marking. Certification to the ISO 13485 standard demonstrates
the presence of a quality management system that can be used by a manufacturer for design and development, production, installation
and servicing of medical devices and the design, development and provision of related services.
Devices that comply with the requirements of the laws of the selected
member state applying the applicable EU directive are entitled to bear a CE mark and can be distributed throughout the member states
of the EU, as well as in other countries that have mutual recognition agreements with the EU or have adopted the EU’s regulatory
standards.
We have identified several potential
countries through which we may pursue a CE mark for AC5.
We currently anticipate filing our first CE mark
application after receiving allowance of a 510(K) regulatory submission in the U.S. We have identified several potential
countries through which we may pursue a CE mark for AC5.
Clinical Trials
As with U.S. Class III and certain Class II medical device approvals,
EU Class III and certain Class II medical device approvals require the successful completion of human clinical trials. However,
there are several key differences between the jurisdictions with respect to the approvals and processes. Obtaining a CE mark is
not equivalent to obtaining FDA approval, in that a CE mark confirms the safety, but not the effectiveness, of a product. Furthermore,
a CE mark affixed to a product serves as a declaration by the responsible party that the product conforms to applicable provisions
and that relevant conformity assessment procedures have been completed with respect to the product. Accordingly, we anticipate
that the required EU clinical trial(s) for AC5 will be smaller, faster, and less expensive than what we expect would be required
for AC5 to obtain equivalent approvals in the U.S.
Post-Approval Regulation
After a medical device obtains approval from the applicable regulatory
agency and is launched in the market, numerous post-approval regulatory requirements would apply. Many of those requirements are
similar in the U.S. and in member states of the EU, and include:
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product listing and
establishment registration;
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requirements that manufacturers,
including third-party manufacturers, follow stringent design, testing, control, documentation and other quality assurance procedures
during all aspects of the design and manufacturing process;
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labeling and other advertising
regulations, including prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;
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approval of product
modifications that affect the safety or effectiveness of any of our devices that may achieve approval;
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post-approval restrictions
or conditions, including post-approval study commitments;
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post-market surveillance
regulations, which apply, when necessary, to protect the public health or to provide additional safety and effectiveness data
for the device;
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the recall authority
of the applicable government agency and regulations pertaining to voluntary recalls; and
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reporting requirements,
including reports of incidents in which a product may have caused or contributed to a death or serious injury or in which a product
malfunctioned, and notices of corrections or removals.
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Failure by us or by our third-party manufacturers and other suppliers
to comply with applicable regulatory requirements could result in enforcement action by various regulatory authorities, which may
result in monetary fines, the imposition of operating restrictions, product recalls, criminal prosecution or other sanctions.
Regulation by Other Foreign Agencies
International sales of medical devices outside the EU may be subject
to government regulations in each country in which the device is marketed and sold, which vary substantially from country to country.
The time required to obtain approval by a non-EU foreign country may be longer or shorter than that required for FDA or CE mark
clearance or approval, and the requirements may substantially differ.
Other Governmental Regulations and Environmental Matters
We are or may become subject to various laws and regulations regarding
laboratory practices and the use of animals in testing, as well as environmental laws and regulations governing, among other things,
any use and disposal by us of hazardous or potentially hazardous substances in connection with our research. At this time, costs
attributable to environmental compliance are not material. In each of these areas, applicable U.S. and foreign government agencies
have broad regulatory and enforcement powers, including, among other things, the ability to levy fines and civil penalties, suspend
or delay issuance of approvals, seize or recall products, and withdraw approvals, any one or more of which could have a material
adverse effect on our business. Additionally, if we are able to successfully obtain approvals for and commercialize our product
candidates, then the Company and our products may become subject to various federal, state and local laws targeting fraud, abuse,
privacy and security in the healthcare industry.
Intellectual Property
We are focused on the development of self-assembling compositions,
particularly self-assembling peptide compositions, and methods of making and using such compositions primarily in healthcare applications.
Suitable applications of these compositions include limiting or preventing the movement of bodily fluids and contaminants within
or on the human body, preventing adhesions, treatment of leaky or damaged tight junctions, and reinforcement of weak or damaged
vessels, such as aneurysms. Our strategy to date has been to develop an intellectual property portfolio in high-value jurisdictions
that tend to uphold intellectual property rights.
As of October 27, 2017, we either own or license from others
a number of U.S. patents, U.S. patent applications, foreign patents and foreign patent applications.
Three patent portfolios assigned to Arch Biosurgery, Inc. include
a total of 27 patents and pending applications in a total of nine jurisdictions, including seven patents and pending applications
in the US. These portfolios cover self-assembling peptides and methods of use thereof and self-assembling peptidomimetics and methods
of use thereof, including four issued US patents (US 9,415,084; US 9,162,005; US 9,789,157; and US 9,339,476) that expire between
2026 and 2034 (absent patent term extension), and one US application that has been allowed (US Application No. 15/156,020), as
well as eight patents that have been either allowed, issued or granted in foreign jurisdictions.
We have also entered into a license agreement with Massachusetts
Institute of Technology and Versitech Limited (“MIT”) pursuant to which we have been granted exclusive rights under
two portfolios of patents and non-exclusive rights under another three portfolios of patents.
The two portfolios exclusively licensed from MIT include a total
of 23 patents and pending applications drawn to self-assembling peptides and methods of use thereof and self-assembling peptidomimetics
and methods of use thereof in a total of nine jurisdictions. The portfolios include four issued US patents (US 9,511,113; US 9,084,837;
US 9,327,010; and US 9,364,513) that expire between 2026 and 2027 (absent patent term extension), as well as twelve patents that
have been either allowed, issued or granted in foreign jurisdictions
.
The three portfolios non-exclusively licensed from MIT include
a number of US and foreign applications, including four issued US patents (US 7,449,180; US 7,846,891; US 7,713,923; and US 8,901,084)
that expire between 2021 and 2027 (absent patent term extension), as well as four patents that have been either allowed, issued
or granted in foreign jurisdictions.
Our license agreement with MIT imposes certain diligence, capital
raising, and other obligations on us, including obligations to raise certain amounts of capital by specific dates. Additionally,
we are responsible for all patent prosecution and maintenance fees under that agreement. Our breach of any material terms of our
license agreement with MIT could permit the counterparty to terminate the agreement, which could result in our loss of some or
all of our rights to use certain intellectual property that is material to our business and our lead product candidate. Our loss
of any of the rights granted to us under our license agreement with MIT could materially harm our product development efforts and
could cause our business to fail.
We have pending trademark applications for AC5 Surgical Hemostatic
Device™, AC5 Surgical Hemostat™, AC5™, Crystal Clear Surgery™, NanoDrape™ and NanoBioBarrier™.
Employees
We presently have eight full-time employees and two part-time employees,
and make extensive use of third party contractors, consultants, and advisors to perform many of our present activities. We expect
to increase the number of our employees as we increase our operations.
ITEM 1A. RISK FACTORS
Investment in our Common Stock involves a high degree of risk.
You should carefully consider the following risk factors before making an investment decision. If any of the following risks and
uncertainties actually occurs, our business, financial condition, and results of operations could be negatively impacted and you
could lose all or part of your investment.
Risks Related to our Business
There is substantial doubt about our ability to continue as
a going concern.
We are a development stage company with no commercial products.
Our primary product candidate is in the process of being developed, and will require additional clinical development and investment
before it could potentially be commercialized. As a result, we have not generated any revenue from operations since inception,
and we have incurred substantial net losses to date. While as of November 14, 2017, we believe that our current cash on hand will
meet our anticipated cash requirements into the fourth quarter of Fiscal 2018, depending upon additional input from EU and US regulatory
authorities, as well as our potential for additional regulatory filing(s), approval(s) and allowance(s) in 2017 and 2018, we will
need to raise additional capital prior to the fourth quarter of Fiscal 2018. In any event, during or prior to the fourth quarter
of Fiscal 2018, we will need to obtain additional cash to continue operations and fund our planned future operations, which include
research and development of our primary product candidate, seeking regulatory approval for that product candidate, and pursuing
its commercialization in the U.S., Europe and other markets. Those circumstances raise substantial doubt about our ability to continue
as a going concern.
We have incurred significant losses since inception. We expect
to continue to incur losses for the foreseeable future, and we may never generate revenue or achieve or maintain profitability.
As noted above under the risk factor entitled “
There
is substantial doubt about our ability to continue as a going concern
,
”
we are a development stage company
with no commercial products. Consequently, we have incurred losses in each year since our inception and we expect that losses will
continue to be incurred in the foreseeable future in the operation of our business. To date, we have financed our operations entirely
through equity and debt investments by founders, other investors and third parties, and we expect to continue to rely on these
sources of funding, to the extent available in the foreseeable future. Losses from operations have resulted principally from costs
incurred in research and development programs and from general and administrative expenses, including significant costs associated
with establishing and maintaining intellectual property rights, significant legal and accounting costs incurred in connection with
both the closing of the Merger and complying with public company reporting and control obligations, and personnel expenses. We
have devoted much of our operations to date to the research and development of our core technology, including selecting our initial
product composition, conducting initial safety and other related tests, generating scale-up, reproducibility and manufacturing
and formulation methods, conducting our initial clinical trial for AC5, and developing and protecting the intellectual property
rights underlying our technology platform.
We expect to continue to incur significant expenses and we anticipate
that those expenses and losses may increase in the foreseeable future as we seek to:
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develop our principal
product candidate, AC5, and the underlying technology, including advancing applications and conducting biocompatibility and other
preclinical studies;
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raise capital needed
to fund our operations;
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build and enhance investor
relations and corporate communications capabilities;
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conduct additional clinical
trials relating to AC5 and any other product candidate we seek to develop;
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attempt to gain regulatory
approvals for product candidates;
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build relationships
with contract manufacturing partners, and invest in product and process development through such partners;
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maintain, expand and
protect our intellectual property portfolio;
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advance additional product
candidates and technologies through our research and development pipeline;
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seek to commercialize
selected product candidates which may require regulatory approval; and
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hire additional regulatory,
clinical, quality control, scientific, financial, and management, consultants and advisors.
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To become and remain profitable, we must succeed in developing and
eventually commercializing product candidates with significant market potential. This will require us to be successful in a number
of challenging activities, including successfully completing preclinical testing and clinical trials of product candidates, obtaining
regulatory approval for our product candidates and manufacturing, marketing and selling any products for which we may obtain regulatory
approval. We are only in the preliminary stages of many of those activities. We may never succeed in those activities and may never
generate operating revenues or achieve profitability. Even if we do generate operating revenues sufficient to achieve profitability,
we may not be able to sustain or increase profitability. Our failure to generate operating revenues or become and remain profitable
would impair our ability to raise capital, expand our business or continue our operations, all of which would depress the price
of our Common Stock. A further decline or lack of increase in the prices of our Common Stock could cause our stockholders to lose
all or a part of their investment in the Company.
We will need substantial additional funding and may be unable
to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization
efforts and could cause our business to fail.
Based on our current operating expenses and working capital requirements,
as of November 14, 2017, we believe that our current cash on hand will meet our anticipated cash requirements into the fourth quarter
of Fiscal 2018. Notwithstanding that, depending upon additional input from EU and US regulatory authorities, as well as the potential
for more than one regulatory filing and approval in Fiscal 2018 we may need to raise additional capital prior to the fourth quarter
of Fiscal 2018. In any event, during or prior to the fourth quarter of Fiscal 2018, we will need to obtain additional cash to continue
operations and fund our planned future operations, including the continuation of our ongoing research and development efforts,
the licensing or acquisition of new assets, and researching and developing any potential patents, the related compounds and any
further intellectual property that we may acquire. In addition, our plans may change and/or we may use our capital resources more
rapidly than we currently anticipate. We presently expect that our expenses will increase in connection with our ongoing activities
to support our business operations inclusive of regulatory applications and approval of AC5 in the U.S. and Europe and therefore
we will require additional funding. Our future capital requirements will depend on many factors, including:
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the scope, progress
and results of our research, preclinical, and clinical development activities;
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the scope, progress
and results of our research and development collaborations;
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the extent of potential
direct or indirect grant funding for our research and development activities;
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the scope, progress,
results, costs, timing and outcomes of any regulatory process and clinical trials conducted for any of our product candidates;
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the timing of entering
into, and the terms of, any collaboration agreements with third parties relating to any of our product candidates;
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the timing of and the
costs involved in obtaining regulatory approvals for our product candidates;
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the costs of operating,
expanding and enhancing our operations to support our clinical activities and, if our product candidates are approved, commercialization
activities;
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the costs of maintaining,
expanding and protecting our intellectual property portfolio, including potential litigation costs and liabilities;
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the costs associated
with maintaining and expanding our product pipeline;
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the costs associated
with expanding our geographic focus;
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operating revenues,
if any, received from sales of our product candidates, if any are approved by the U.S. Food and Drug Administration (“
FDA
”)
or other applicable regulatory agencies;
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the cost associated
with being a public company, including obligations to regulatory agencies, and increased investor relations and corporate communications
expenses; and
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the costs of additional
general and administrative personnel, including accounting and finance, legal and human resources employees.
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We intend to obtain additional financing for our business through
public or private securities offerings, the incurrence of additional indebtedness, or some combination of those sources. We have
obtained research and development support through collaborative arrangements, such as the Project Agreement that we entered into
with the National University of Ireland Galway (“
NUIG
”) on May 28, 2015, and we may continue to seek funding
through additional collaborative arrangements with strategic partners if we determine them to be necessary or appropriate, although
these arrangements could require us to relinquish rights to our technology or product candidates and could result in our receipt
of only a portion of any revenues associated with the partnered product. We cannot provide any assurance that additional financing
from these sources will be available on favorable terms, if at all. In addition, we are bound by certain contractual terms and
obligations that may limit or otherwise impact our ability to raise additional funding in the near-term including, but not limited
to, provisions in the Securities Purchase Agreement that we entered into on February 20, 2017 (the “
2017 SPA
”)
in connection with the registered direct financing that closed on February 24, 2017 (the “
2017 Financing
”).
In particular, certain provisions within the 2017 SPA restrict our ability to effect or enter into an agreement to effect any issuance
by us or any of our subsidiaries of Common Stock or securities convertible, exercisable or exchangeable for Common Stock (or a
combination of units thereof) involving a Variable Rate Transaction (as defined in the 2017 SPA) including, but not limited to,
an equity line of credit or “At-the-Market” financing facility until the three lead investors in the 2017 Financing
collectively own less than 20% of the Series F Warrants purchased by them pursuant to the 2017 SPA. These restrictions and provisions
could make it more challenging for us to raise capital through the incurrence of additional debt or through future equity issuances.
Further, if we do raise capital through the sale of equity, or securities convertible into equity, the ownership of our then existing
stockholders would be diluted, which dilution could be significant depending on the price at which we may be able to sell our securities.
Also, if we raise additional capital through the incurrence of indebtedness, we may become subject to covenants restricting our
business activities, and the holders of debt instruments may have rights and privileges senior to those of our equity investors.
Finally, servicing the interest and principal repayment obligations under any debt facilities that we may enter into in the future
could divert funds that would otherwise be available to support research and development, clinical or commercialization activities.
If we are unable to obtain adequate financing on a timely basis
or on acceptable terms in the future, we would likely be required to delay, reduce or eliminate one or more of our product development
activities, which could cause our business to fail.
The terms of the 2017 Financing could impose additional challenges
on our ability to raise funding in the future.
The 2017 SPA imposes certain restrictions on our ability to issue
equity or debt securities. In particular, the 2017 SPA includes provisions restricting our ability to effect or enter into an agreement
to effect any issuance by the Company or any of its subsidiaries of Common Stock or securities convertible, exercisable or exchangeable
for Common Stock (or a combination of units thereof) involving a Variable Rate Transaction until the three lead investors in the
2017 Financing collectively own less than 20% of the Series F Warrants purchased by them pursuant to the 2017 SPA. As of November
14, 2017, none of the lead investors have exercised or transferred any of their Series F Warrants. As defined in the 2017 SPA,
Variable Rate Transaction means a transaction in which the Company (a) issues or sells any debt or equity securities that are convertible
into, exchangeable or exercisable for, or include the right to receive additional shares of Common Stock either (A) at a conversion
price, exercise price or exchange rate or other price that is based upon and/or varies with the trading prices of or quotations
for the shares of Common Stock at any time after the initial issuance of such debt or equity securities, or (B) with a conversion,
exercise or exchange price that is subject to being reset at some future date after the initial issuance of such debt or equity
security or upon the occurrence of specified or contingent events directly or indirectly related to the business of the Company
or the market for the Common Stock (excluding adjustments under customary anti-dilution provisions) or (b) enters into, or effects
a transaction under, any agreement, including, but not limited to, an equity line of credit, whereby the Company may issue securities
at a future determined price. These provisions could make our securities less attractive to investors and could limit our ability
to obtain adequate financing on a timely basis or on acceptable terms in the future, which could have significant harmful effects
on our financial condition and business and could include substantial limitations on our ability to continue to conduct operations.
Our short operating history may hinder our ability to successfully
meet our objectives.
We are a development stage company subject to the risks, uncertainties
and difficulties frequently encountered by early-stage companies in evolving markets. Our operations to date have been primarily
limited to organizing and staffing, developing and securing our technology and undertaking funding preclinical studies of our lead
product candidates, and funding one clinical trial. We have not demonstrated our ability to successfully complete large-scale,
pivotal clinical trials, obtain regulatory approvals, manufacture a commercial scale product or arrange for a third party to do
so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.
Because of our limited operating history, we have limited insight
into trends that may emerge and affect our business, and errors may be made in developing an approach to address those trends and
the other challenges faced by development stage companies. Failure to adequately respond to such trends and challenges could cause
our business, results of operations and financial condition to suffer or fail. Further, our limited operating history may make
it difficult for our stockholders to make any predictions about our likelihood of future success or viability.
If we are not able to attract and retain qualified management
and scientific personnel, we may fail to develop our technologies and product candidates.
Our future success depends to a significant degree on the skills,
experience and efforts of the principal members of our scientific and management personnel. These members include Terrence Norchi,
MD, our President and Chief Executive Officer. The loss of Dr. Norchi or any of our other key personnel could harm our business
and might significantly delay or prevent the achievement of research, development or business objectives. Further, our operation
as a public company will require that we attract additional personnel to support the establishment of appropriate financial reporting
and internal controls systems. Competition for personnel is intense. We may not be able to attract, retain and/or successfully
integrate qualified scientific, financial and other management personnel, which could materially harm our business.
If we fail to properly manage any growth we may experience,
our business could be adversely affected.
We anticipate increasing the scale of our operations as we seek
to develop our product candidates, including hiring and training additional personnel and establishing appropriate systems for
a company with larger operations. The management of any growth we may experience will depend, among other things, upon our ability
to develop and improve our operational, financial and management controls, reporting systems and procedures. If we are unable to
manage any growth effectively, our operations and financial condition could be adversely affected.
If we fail to maintain appropriate internal controls in the
future, we may not be able to report our financial results accurately, which may adversely affect our stock price and our business.
Our efforts to comply with Section 404 of the Sarbanes-Oxley Act
of 2002 and the related regulations regarding our required assessment of our internal controls over financial reporting requires
the commitment of significant financial and managerial resources. Internal control over financial reporting has inherent limitations,
including human error, the possibility that controls could be circumvented or become inadequate because of changed conditions,
and fraud. If we are unable to maintain effective internal controls, we may not have adequate, accurate or timely financial information,
and we may be unable to meet our reporting obligations as a publicly traded company or comply with the requirements of the SEC
or the Sarbanes-Oxley Act of 2002. This could result in a restatement of our financial statements, the imposition of sanctions,
including the inability of registered broker dealers to make a market in our stock, or investigation by regulatory authorities.
Any such action or other negative results caused by our inability to meet our reporting requirements or comply with legal and regulatory
requirements or by disclosure of an accounting, reporting or control issue could adversely affect the trading price of our stock
and our business.
We rely significantly on information technology and any failure,
inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to
operate our business effectively.
We maintain sensitive data pertaining to our Company on our computer
networks, including information about our research and development activities, our intellectual property and other proprietary
business information. Our internal computer systems and those of third parties with which we contract may be vulnerable to damage
from cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical
failures, despite the implementation of security measures. System failures, accidents or security breaches could cause interruptions
to our operations, including material disruption of our research and development activities, result in significant data losses
or theft of our intellectual property or proprietary business information, and could require substantial expenditures to remedy.
To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications or inappropriate
disclosure of confidential or proprietary information, we could incur liability and our research and development programs could
be delayed, any of which would harm our business and operations.
Risks Related to the Development and Commercialization
of our Product Candidates
Our business plan is dependent on the success of our flagship
development stage product candidates, known collectively as the AC5 devices.
Our business is currently focused almost entirely on the development
and commercialization of our flagship development stage product candidates, known collectively as the AC5 devices. Our reliance
on the AC5 devices means that, if we are not able to obtain regulatory approvals and market acceptance of at least one of those
product candidates, our chances for success will be significantly reduced. We are also less likely to withstand competitive pressures
if any of our competitors develops and obtains regulatory approval or certification for similar products faster than we can or
that is otherwise more attractive to the market than the AC5 devices. Our current dependence on the AC5 devices increases the risk
that our business will fail if our development efforts for the AC5 devices experience delays or other obstacles or are otherwise
not successful.
The Chemistry, Manufacturing and Control (“CMC”)
process may be challenging.
Because of the complexity of our lead product candidates, the CMC
process, including but not limited to product scale-up activities and cGMP manufacturing for human use, may be difficult to complete
successfully within the parameters required by the FDA or its foreign counterparts. Peptide formulation optimization is particularly
challenging, and any delays could negatively impact our ability to conduct clinical trials and our subsequent commercialization
timeline. Furthermore, we have, and the third parties with whom we may establish relationships may also have, limited experience
with attempting to commercialize a self-assembling peptide as a medical device, which increases the risks associated with completing
the CMC process successfully, on time, or within the projected budget. Failure to complete the CMC process successfully would impact
our ability to complete product development activities, such as conducting clinical trials and submitting applications for regulatory
approval, which could affect the long-term viability of our business.
Our principal product candidates are inherently risky because
they are based on novel technologies.
We are subject to the risks of failure inherent in the development
of products based on new technologies. The novel nature of the AC5 devices creates significant challenges with respect to product
development and optimization, engineering, manufacturing, scale-up, quality systems, pre-clinical in vitro and in vivo testing,
government regulation and approval, third-party reimbursement and market acceptance. Our failure to overcome any one of those challenges
could harm our operations, ability to complete additional clinical trials, and overall chances for success.
If we are required or voluntarily decide to change
manufacturers for commercial or other reasons, the FDA and any other applicable regulatory bodies would also require that we demonstrate
structural and functional comparability between the same products manufactured by our current and any new manufacturer and may
require comparability studies to be performed before qualifying such new manufacturer.
As noted above, we are dependent on third-party manufacturers,
and this dependence exposes us to increased risks associated with delivery schedules, manufacturing capability, quality control,
quality assurance and costs. Our contract manufacturers may not perform as agreed. If we are required to or voluntarily decide
to find a new contract manufacturer, qualifying such new contract manufacturer may be expensive and time consuming since, among
other things, the FDA and any other applicable regulatory bodies would also require that we demonstrate structural and functional
comparability between the same products manufactured by our current and any new manufacturer and may require comparability studies
to be performed before qualifying such new manufacturer. This qualification process may affect product availability, which may
in turn adversely affect our business.
The manufacturing, production, and sterilization methods that
we intend to be utilized are detailed and complex and are a difficult process to manage.
We intend to utilize third party manufacturers to manufacture and
sterilize our products. We believe that our proposed manufacturing methods make our choice of manufacturer and sterilizer critical,
as they must possess sufficient expertise in synthetic organic chemistry and device manufacturing. If such manufacturers are unable
to properly manufacture to product specifications or sterilize our products adequately, that could severely limit our ability to
market our products.
Compliance with governmental regulations regarding the treatment
of animals used in research could increase our operating costs, which would adversely affect the commercialization of our technology.
The Animal Welfare Act (“
AWA
”) is the federal
law that covers the treatment of certain animals used in research. Currently, the AWA imposes a wide variety of specific regulations
that govern the humane handling, care, treatment and transportation of certain animals by producers and users of research animals,
most notably relating to personnel, facilities, sanitation, cage size, and feeding, watering and shipping conditions. Third parties
with whom we contract are subject to registration, inspections and reporting requirements under the AWA. Furthermore, some states
have their own regulations, including general anti-cruelty legislation, which establish certain standards in handling animals.
Comparable rules, regulations, and or obligations exist in many foreign jurisdictions. If our contractors or we fail to comply
with regulations concerning the treatment of animals used in research, we may be subject to fines and penalties and adverse publicity,
and our operations could be adversely affected.
If the FDA or similar foreign agencies or intermediaries impose
requirements or an alternative product classification more onerous than we anticipate, our business could be adversely affected.
The development plan for our lead product candidates is based on
our anticipation of pursuing the medical device regulatory pathway, and in February 2015 we received confirmation from The British
Standards Institution (“
BSI
”), a Notified Body (which is a private commercial entity designated by the national
government of a European Union (“
EU
”) member state as being competent to make independent judgments about whether
a medical device complies with applicable regulatory requirements) in the EU, confirmed that AC5 fulfills the definition of a medical
device within the EU and will be classified as such in consideration for CE mark designation. The FDA and other regulatory authorities
or related bodies separately determine the classification of AC5. The FDA also determined our current product to be a medical device.
If the FDA or similar foreign agencies or intermediaries deem our product to be a member of a category other than a medical device,
such as a drug or biologic, or impose additional requirements on our pre-clinical and clinical development than we presently anticipate,
financing needs would increase, the timeline for product approval would lengthen, the program complexity and resource requirements
world increase, and the probability of successfully commercializing a product would decrease. Any or all of those circumstances
would materially adversely affect our business.
We are subject to extensive and dynamic medical device regulations
outside of the United States, which may impede or hinder the approval or sale of our products and, in some cases, may ultimately
result in an inability to obtain approval of certain products or may result in the recall or seizure of previously approved products.
In the European Union, we are required to comply with applicable
medical device directives, including the Medical Devices Directive, and obtain CE Marking in order to market medical device products.
The CE Mark is applied following approval from an independent notified body or declaration of conformity. As is the case in the
United States, the process of obtaining marketing approval or clearance from comparable agencies in foreign countries for new products,
or with respect to enhancements or modifications to existing products, could:
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take a significant period
of time;
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require the expenditure
of substantial resources;
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involve rigorous pre-clinical
and clinical testing;
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require extensive post-marketing
surveillance;
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require changes to products;
and
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result in limitations
on the indicated uses of products.
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In addition, exported devices are subject to the regulatory requirements
of each country to which the device is exported. Most foreign countries possess medical devices regulations and require that they
be applied to medical devices before they can be commercialized. There can be no assurance that we will receive the required approvals
for our products on a timely basis or that any approval will not be subsequently withdrawn or conditioned upon extensive post-market
study requirements.
Our global regulatory environment is becoming increasingly stringent
and unpredictable, which could increase the time, cost and complexity of obtaining regulatory approvals for our products, as well
as the clinical and regulatory costs of supporting those approvals. Several countries that did not have regulatory requirements
for medical devices have established such requirements in recent years and other countries have expanded existing regulations.
Certain regulators are exhibiting less flexibility by requiring, for example, the collection of local preclinical and/or clinical
data prior to approval. While harmonization of global regulations has been pursued, requirements continue to differ significantly
among countries. We expect the global regulatory environment to continue to evolve, which could impact our ability to obtain future
approvals for our products and increase the cost and time to obtain such approvals. By way of example, the European Union regulatory
bodies recently finalized a new Medical Device Regulation (MDR). The MDR changes several aspects of the existing regulatory framework,
such as clinical data requirements, and introduces new ones, such as Unique Device Identification (UDI). We, and the Notified Bodies
who will oversee compliance to the new MDR, face uncertainties in the upcoming years as the MDR is rolled out and enforced, creating
risks in several areas, including the CE Marking process, data transparency and application review timetables.
If we are not able to secure and maintain relationships with
third parties that are capable of conducting clinical trials on our product candidates and support our regulatory submissions,
our product development efforts, and subsequent regulatory approvals could be adversely impacted.
Our management has limited experience in conducting preclinical
development activities and clinical trials. As a result, we have relied and will need to continue to rely on third party research
institutions, organizations and clinical investigators to conduct our preclinical and clinical trials and support our regulatory
submissions. If we are unable to reach agreement with qualified research institutions, organizations and clinical investigators
on acceptable terms, or if any resulting agreement is terminated prior to the completion of our clinical trials, then our product
development efforts could be materially delayed or otherwise harmed. Further, our reliance on third parties to conduct our clinical
trials and support our regulatory submissions will provide us with less control over the timing and cost of those trials, the ability
to recruit suitable subjects to participate in the trials, and the timing, cost, and probability of success for the regulatory
submissions. Moreover, the FDA and other regulatory authorities require that we comply with standards, commonly referred to as
good clinical practices (“
GCP
”), for conducting, recording and reporting the results of our preclinical development
activities and our clinical trials, to assure that data and reported results are credible and accurate and that the rights, safety
and confidentiality of trial participants are protected. Additionally, both we and any third party contractor performing preclinical
and clinical studies are subject to regulations governing the treatment of human and animal subjects in performing those studies.
Our reliance on third parties that we do not control does not relieve us of those responsibilities and requirements. If those third
parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our preclinical development
activities or clinical trials in accordance with regulatory requirements or stated protocols, we may not be able to obtain, or
may be delayed in obtaining, regulatory approvals for our product candidates and will not be able to, or may be delayed in our
efforts to, successfully commercialize our product candidates. Any of those circumstances would materially harm our business and
prospects.
Any clinical trials that are planned or are conducted on our
product candidates may not start or may fail.
Clinical trials are lengthy, complex and extremely expensive processes
with uncertain expenditures and results and frequent failures. While the Company has completed its first clinical trial in Western
Europe, clinical trials that are planned or which have or shall commence for any of our product candidates could be delayed or
fail for a number of reasons, including if:
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the FDA or other regulatory
authorities, or other relevant decision making bodies do not grant permission to proceed or place a trial on clinical hold due
to safety concerns or other reasons;
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sufficient suitable
subjects do not enroll, enroll more slowly than anticipated or remain in our trials;
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we fail to produce necessary
amounts of product candidate;
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subjects experience
an unacceptable rate of efficacy of the product candidate;
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subjects experience
an unacceptable rate or severity of adverse side effects, demonstrating a lack of safety of the product candidate;
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any portion of the trial
or related studies produces negative or inconclusive results or other adverse events;
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reports from preclinical
or clinical testing on similar technologies and products raise safety and/or efficacy concerns;
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third-party clinical
investigators lose their licenses or permits necessary to perform our clinical trials, do not perform their clinical trials on
the anticipated schedule or consistent with the clinical trial protocol, GCP or regulatory requirements, or other third parties
do not perform data collection and analysis in a timely or accurate manner;
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inspections of clinical
trial sites by the FDA or an institutional review board (“
IRB
”) or other applicable regulatory authorities
find violations that require us to undertake corrective action, suspend or terminate one or more testing sites, or prohibit us
from using some or all of the resulting data in support of our marketing applications with the FDA or other applicable agencies;
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manufacturing facilities
of our third party manufacturers are ordered by the FDA or other government or regulatory authorities to temporarily or permanently
shut down due to violations of current good manufacturing practices (“
cGMP
”) or other applicable requirements;
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third-party contractors
become debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of
regulatory requirements;
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the FDA or other regulatory
authorities impose requirements on the design, structure or other features of the clinical trials for our product candidates that
we and/or our third party contractors are unable to satisfy;
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one or more IRB refuses
to approve, suspends or terminates a trial at an investigational site, precludes enrollment of additional subjects, or withdraws
its approval of the trial;
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the FDA or other regulatory
authorities seek the advice of an advisory committee of physician and patient representatives that may view the risks of our product
candidates as outweighing the benefits;
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the FDA or other regulatory
authorities require us to expand the size and scope of the clinical trials, which we may not be able to do; or
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the FDA or other regulatory
authorities impose prohibitive post-marketing restrictions on any of our product candidates that attain regulatory approval.
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Any delay or failure of one or more of our clinical trials may occur
at any stage of testing. Any such delay could cause our development costs to materially increase, and any such failure could significantly
impair our business plans, which would materially harm our financial condition and operations.
We cannot market and sell any product candidate in the U.S.
or in any other country or region if we fail to obtain the necessary regulatory approvals, clearances or certifications from applicable
government agencies.
We cannot sell our product candidates in any country until regulatory
agencies grant marketing approval, clearance or other required certification. The process of obtaining such approval is lengthy,
expensive and uncertain. If we are able to obtain such approvals for our lead product candidate or any other product candidate
we may pursue, which we may never be able to do, it would likely be a process that takes many years to achieve.
To obtain marketing approvals in the U.S. for our product candidates,
we believe that we must, among other requirements, complete carefully controlled and well-designed clinical trials sufficient to
demonstrate to the FDA that the product candidate is safe and effective for each indication for which we seek approval. As described
above, many factors could cause those trials to be delayed or to fail.
We believe that the pathway to marketing approval in the U.S. for
our lead product candidate for internal use will likely require the process of FDA Premarket Approval (“
PMA
“)
for the product, which is based on novel technologies and likely will be classified as a Class III medical device. This approval
pathway can be lengthy and expensive, and is estimated to take from one to three years or longer from the time the PMA application
is submitted to the FDA until approval is obtained, if approval can be obtained at all.
Similarly, to obtain approval to market our product candidates outside
of the U.S., we will need to submit clinical data concerning our product candidates to and receive marketing approval or other
required certifications from governmental or other agencies in those countries, which in certain countries includes approval of
the price we intend to charge for a product. For instance, in order to obtain the certification needed to market our lead product
candidate in the EU, we believe that we will need to obtain a CE mark for the product, which entails scrutiny by applicable regulatory
agencies and bears some similarity to the PMA process, including completion of one or more successful clinical trials.
We may encounter delays or rejections if changes occur in regulatory
agency policies, if difficulties arise within regulatory or related agencies such as, for instance, any delays in their review
time, or if reports from preclinical and clinical testing on similar technology or products raise safety and/or efficacy concerns
during the period in which we develop a product candidate or during the period required for review of any application for marketing
approval or certification.
Any difficulties we encounter during the approval or certification
process for any of our product candidates would have a substantial adverse impact on our operations and financial condition and
could cause our business to fail.
We cannot guarantee that we will be able to effectively market
our product candidates.
A significant part of our success depends on the various marketing
strategies we plan to implement. Our business model has historically focused solely on product development, and we have never attempted
to commercialize any product. There can be no assurance as to the success of any such marketing strategy that we develop or that
we will be able to build a successful sales and marketing organization. If we cannot effectively market those products we seek
to commercialize directly, such products’ prospects will be harmed.
Any product for which we obtain required regulatory approvals
could be subject to post-approval regulation, and we may be subject to penalties if we fail to comply with such post-approval requirements.
Any product for which we are able to obtain marketing approval or
other required certifications, and for which we are able to obtain approval of the manufacturing processes, post-approval clinical
data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review
by the FDA and comparable foreign regulatory authorities, including through periodic inspections. These requirements include, without
limitation, submissions of safety and other post-marketing information and reports, registration requirements, cGMP requirements
relating to quality control, quality assurance and corresponding maintenance of records and documents. Maintaining compliance with
any such regulations that may be applicable to us or our product candidates in the future would require significant time, attention
and expense. Even if marketing approval of a product is granted, the approval may be subject to limitations on the indicated uses
for which the product may be marketed or other conditions of approval, or may contain requirements for costly and time consuming
post-marketing approval testing and surveillance to monitor the safety or efficacy of the product. Discovery after approval of
previously unknown problems with any approved product candidate or related manufacturing processes, or failure to comply with regulatory
requirements, may result in consequences to us such as:
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restrictions on the
marketing or distribution of a product, including refusals to permit the import or export of the product;
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the requirement to include
warning labels on the products;
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withdrawal or recall
of the products from the market;
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refusal by the FDA or
other regulatory agencies to approve pending applications or supplements to approved applications that we may submit;
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suspension of any ongoing
clinical trials;
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fines, restitution or
disgorgement of profits or revenue;
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suspension or withdrawal
of marketing approvals or certifications; or
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civil or criminal penalties.
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If any of our product candidates achieves required regulatory marketing
approvals or certifications in the future, the subsequent occurrence of any such post-approval consequences would materially adversely
affect our business and operations.
Current or future legislation may make it more difficult and
costly for us to obtain marketing approval or other certifications of our product candidates.
In 2007, the Food and Drug Administration Amendments Act of 2007
(the “
FDAAA
”) was adopted. This legislation grants significant powers to the FDA, many of which are aimed at
assuring the safety of medical products after approval. For example, the FDAAA grants the FDA authority to impose post-approval
clinical study requirements, require safety-related changes to product labeling and require the adoption of complex risk management
plans. Pursuant to the FDAAA, the FDA may require that a new product be used only by physicians with specialized training, only
in specified health care settings, or only in conjunction with special patient testing and monitoring. The legislation also includes
requirements for disclosing clinical study results to the public through a clinical study registry, and renewed requirements for
conducting clinical studies to generate information on the use of products in pediatric patients. Under the FDAAA, companies that
violate these laws are subject to substantial civil monetary penalties. The requirements and changes imposed by the FDAAA, or any
other new legislation, regulations or policies that grant the FDA or other regulatory agencies additional authority that further
complicates the process for obtaining marketing approval and/or further restricts or regulates post-marketing approval activities,
could make it more difficult and more costly for us to obtain and maintain approval of any of our product candidates.
Public perception of ethical and social issues may limit or
discourage the type of research we conduct.
Our clinical trials will involve human subjects, and third parties
with whom we contract also conduct research involving animal subjects. Governmental authorities could, for public health or other
purposes, limit the use of human or animal research or prohibit the practice of our technology. Further, ethical and other concerns
about our or our third party contractors’ methods, particularly the use of human subjects in clinical trials or the use of
animal testing, could delay our research and preclinical and clinical trials, which would adversely affect our business and financial
condition.
Use of third parties to manufacture our product candidates
may increase the risk that preclinical development, clinical development and potential commercialization of our product candidates
could be delayed, prevented or impaired.
We have limited personnel with experience in medical device development
and manufacturing, do not own or operate manufacturing facilities, and generally lack the resources and the capabilities to manufacture
any of our product candidates on a clinical or commercial scale. We currently intend to outsource all or most of the clinical and
commercial manufacturing and packaging of our product candidates to third parties. However, we have not established long-term agreements
with any third party manufacturers for the supply of any of our product candidates. There are a limited number of manufacturers
that operate under cGMP regulations and that are capable of and willing to manufacture our lead product candidates utilizing the
manufacturing methods that are required to produce our product candidates, and our product candidates will compete with other product
candidates for access to qualified manufacturing facilities. If we have difficulty locating third party manufacturers to develop
our product candidates for preclinical and clinical work, then our product development programs will experience delays and otherwise
suffer. We may also be unable to enter into agreements for the commercial supply of products with third party manufacturers in
the future, or may be unable to do so when needed or on acceptable terms. Any such events could materially harm our business.
Reliance on third party manufacturers entails risks to our business,
including without limitation:
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the failure of the third
party to maintain regulatory compliance, quality assurance, and general expertise in advanced manufacturing techniques and processes
that may be necessary for the manufacture of our product candidates;
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limitations on supply
availability resulting from capacity and scheduling constraints of the third parties;
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failure of the third
party manufacturers to meet the demand for the product candidate, either from future customers or for preclinical or clinical
trial needs;
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the possible breach
of the manufacturing agreement by the third party; and
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the possible termination
or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.
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The failure of any of our contract manufacturers to maintain high
manufacturing standards could result in harm to clinical trial. participants or patients using the products. Such failure could
also result in product liability claims, product recalls, product seizures or withdrawals, delays or failures in testing or delivery,
cost overruns or other problems that could seriously harm our business or profitability. Further, our contract manufacturers will
be required to adhere to FDA and other applicable regulations relating to manufacturing practices. Those regulations cover all
aspects of the manufacturing, testing, quality control and recordkeeping relating to our product candidates and any products that
we may commercialize in the future. The failure of our third party manufacturers to comply with applicable regulations could result
in sanctions being imposed on us, including fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing
approval or other required certifications of our product candidates, delays, suspension or withdrawal of approvals, license revocation,
seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could significantly and
adversely affect our business, financial condition and operations.
Materials necessary to manufacture our product candidates
may not be available on time, on commercially reasonable terms, or at all, which may delay or otherwise hinder the development
and commercialization of those product candidates.
We will rely on the manufacturers of our product candidates to purchase
from third party suppliers the materials necessary to produce the compounds for preclinical and clinical studies, and may continue
to rely on those suppliers for commercial distribution if we obtain marketing approval or other required certifications for any
of our product candidates. The materials to produce our products may not be available when needed or on commercially reasonable
terms, and the prices for such materials may be susceptible to fluctuations. We do not have any control over the process or timing
of the acquisition of these materials by our manufacturers. Moreover, we currently do not have any agreements relating to the commercial
production of any of these materials. If these materials cannot be obtained for our preclinical and clinical studies, product testing
and potential regulatory approval of our product candidates would be delayed, which would significantly impact our ability to develop
our product candidates and materially adversely affect our ability to meet our objectives and obtain operations success.
We may not be successful in maintaining or establishing collaborations,
which could adversely affect our ability to develop and, if required regulatory approvals are obtained, commercialize our product
candidates.
As demonstrated by the Project Agreement that we entered into with
NUIG on May 28, 2015, we are interested in collaborating with physicians, patient advocacy groups, foundations, government agencies,
and/or other third parties to assist with the development of our product candidates. If required regulatory approvals are obtained
for any of our product candidates, then we may consider entering into additional collaboration arrangements with medical technology,
pharmaceutical or biotechnology companies and/or seek to establish strategic relationships with marketing partners for the development,
sale, marketing and/or distribution of our products within or outside of the U.S. If we elect to expand our current relationship
with NUIG and/or seek additional collaborators in the future but are unable to reach agreements with NUIG and/or such other collaborators,
as applicable, then we may fail to meet our business objectives for the affected product or program. Moreover, collaboration arrangements
are complex and time consuming to negotiate, document and implement, and we may not be successful in our efforts, if any, to establish
and implement additional collaborations or other alternative arrangements. The terms of any collaboration or other arrangements
that we establish may not be favorable to us, and the success of any such collaboration will depend heavily on the efforts and
activities of our collaborators. Any failure to engage successful collaborators could cause delays in our product development and/or
commercialization efforts, which could harm our financial condition and operational results.
We compete with other pharmaceutical and medical device companies,
including companies that may develop products that make our product candidates less attractive or obsolete.
The medical device, pharmaceutical and biotechnology industries
are highly competitive. If our product candidates become available for commercial sale, we will compete in that competitive marketplace.
There are several products on the market or in development that could be competitors with our lead product candidates. Further,
most of our competitors have greater resources or capabilities and greater experience in the development, approval and commercialization
of medical devices or other products than we do. We may not be able to compete successfully against them. We also compete for funding
with other companies in our industry that are focused on discovering and developing novel improvements in surgical bleeding prevention.
We anticipate that competition in our industry will increase. In
addition, the healthcare industry is characterized by rapid technological change, resulting in new product introductions and other
technological advancements. Our competitors may develop and market products that render our lead product candidate or any future
product candidate we may seek to develop non-competitive or otherwise obsolete. Any such circumstances could cause our operations
to suffer.
If we fail to generate market acceptance of our product candidates
and establish programs to educate and train surgeons as to the distinctive characteristics of our product candidates, we will not
be able to generate revenues on our product candidates.
Acceptance in the marketplace of our lead product candidates depends
in part on our and our third party contractors’ ability to establish programs for the training of surgeons in the proper
usage of those product candidates, which will require significant expenditure of resources. Convincing surgeons to dedicate the
time and energy necessary to properly train to use new products and techniques is challenging, and we may not be successful in
those efforts. If surgeons are not properly trained, they may ineffectively use our product candidates. Such misuse could result
in unsatisfactory patient outcomes, patient injury, negative publicity or lawsuits against us. Accordingly, even if our product
candidates are superior to alternative treatments, our success will depend on our ability to gain and maintain market acceptance
for those product candidates among certain select groups of the population and develop programs to effectively train them to use
those products. If we fail to do so, we will not be able to generate revenue from product sales and our business, financial condition
and results of operations will be adversely affected.
We face uncertainty related to pricing, reimbursement and
healthcare reform, which could reduce our potential revenues.
If our product candidates are approved for commercialization, any
sales will depend in part on the availability of direct or indirect coverage and reimbursement from third-party payers such as
government insurance programs, including Medicare and Medicaid, private health insurers, health maintenance organizations and other
healthcare related organizations. If our product candidates obtain marketing approval, pricing and reimbursement may be uncertain.
Both the federal and state governments in the U.S. and foreign governments continue to propose and pass new legislation affecting
coverage and reimbursement policies, which are designed to contain or reduce the cost of healthcare. Further, federal, state and
foreign healthcare proposals and reforms could limit the prices that can be charged for the product candidates that we may develop,
which may limit our commercial opportunity. Adoption of our product candidates by the medical community may be limited if doctors
and hospitals do not receive adequate partial or full reimbursement for use of our products or procedures in which our products
are used, if any are commercialized. In some foreign jurisdictions, marketing approval or allowance could be dependent upon pre-marketing
price negotiations. As a result, any denial of private or government payer coverage or inadequate reimbursement for procedures
performed using our products, before or upon commercialization, could harm our business and reduce our prospects for generating
revenue.
In addition, the U.S. Congress recently adopted legislation regarding
health insurance. As a result of this new legislation, substantial changes could be made to the current system for paying for healthcare
in the U.S., including modifications to the existing system of private payers and government programs, such as Medicare, Medicaid
and State Children’s Health Insurance Program, creation of a government-sponsored healthcare insurance source, or some combination
of those, as well as other changes. Restructuring the coverage of medical care in the U.S. could impact reimbursement for medical
devices such as our product candidates. If reimbursement for our approved product candidates, if any, is substantially less than
we expect, or rebate obligations associated with them are substantially increased, our business could be materially and adversely
impacted.
The use of our product candidates in human subjects may expose
us to product liability claims, and we may not be able to obtain adequate insurance or otherwise defend against any such claims.
We face an inherent risk of product liability claims and currently
have clinical trial liability coverage. We will need to obtain additional product liability insurance coverage if and when we begin
commercialization of any of our product candidates. If claims against us exceed any applicable insurance coverage we may obtain,
then our business could be adversely impacted. Regardless of whether we would be ultimately successful in any product liability
litigation, such litigation could consume substantial amounts of our financial and managerial resources, which could significantly
harm our business.
Risks Related to our Intellectual Property
If we are unable to obtain and maintain protection for
intellectual property rights that we own, seek, or have licensed from other parties, the value of our technology and products will
be adversely affected.
Our success will depend in large part on our ability to obtain
and maintain protection in the U.S. and other countries for the intellectual property rights covering or incorporated into our
technology and products. The ability to obtain patents covering technology in the field of medical devices generally is highly
uncertain and involves complex legal, technical, scientific and factual questions. We may not be able to obtain and maintain patent
protection relating to our technology or products. Many of our owned or licensed patent applications are pending. Even if issued,
patents issued or licensed to us may be challenged, narrowed, invalidated, held to be unenforceable or circumvented, or determined
not to cover our product candidates or our competitors’ products, which could limit our ability to stop competitors from
marketing identical or similar products. Because our patent portfolio includes certain patents and applications that are in-licensed
on a non-exclusive basis, other parties may be able to develop, manufacture, market and sell products with similar features covered
by the same patent rights and technologies, which in turn could significantly undercut the value of any of our product candidates
and adversely affect our business. Our licensed MIT European patent No. 1879606 was recently opposed; however, this patent was
maintained in amended form following an administrative hearing. Both parties have appealed this decision. If the Opponents prevail
in the appeal, European Patent No. 1879606 will be fully or partially invalidated, resulting in potential loss of rights. Our licensed
MIT Japanese patent No. 5204646 was recently challenged in a Japanese court. The Japanese Court issued a decision in our favor
to maintain the patent in its entirety. The Opponent has appealed the decision. If the Opponent prevails in the appeal, Japanese
Patent No. 5204646 will be fully or partially invalidated, resulting in potential loss of rights. Further, we cannot be certain
that we were the first to make the inventions claimed in the patents we own or license, or that protection of the inventions set
forth in those patents was the first to be filed in the U.S. Third parties that have filed patents or patent applications covering
similar technologies or processes may challenge our claim of sole right to use the intellectual property covered by the patents
we own or exclusively license. Moreover, changes in applicable intellectual property laws or interpretations thereof in the U.S.
and other countries may diminish the value of our intellectual property rights or narrow the scope of our patent protection. Any
failure to obtain or maintain adequate protection for our intellectual property would materially harm our business, product development
programs and prospects.
In addition, our proprietary information, trade secrets and
know-how are important components of our intellectual property rights. We seek to protect our proprietary information, trade secrets,
know-how and confidential information, in part, with confidentiality agreements with our employees, corporate partners, outside
scientific collaborators, sponsored researchers, consultants and other advisors. We also have invention or patent assignment agreements
with our employees and certain consultants and advisors. If our employees or consultants breach those agreements, we may not have
adequate remedies for any of those breaches. In addition, our proprietary information, trade secrets and know-how may otherwise
become known to or be independently developed by others. Enforcing a claim that a party illegally obtained and/or for which a party
is using our proprietary information, trade secrets and/or know-how is difficult, expensive and time consuming, and the outcome
is unpredictable. In addition, courts outside the U.S. may be less willing to protect trade secrets. Costly and time-consuming
litigation could be necessary to seek to defend, enforce and/or determine the scope of our intellectual property rights, and failure
to obtain or maintain protection thereof could adversely affect our competitive business position and results of operations.
Many of our owned or licensed patent applications are pending,
and our patent portfolio includes certain patents and applications that are in-licensed on a non-exclusive basis.
As of October 27, 2017, we either own or license from others a number
of U.S. patents, U.S. patent applications, foreign patents and foreign patent applications.
Three patent portfolios assigned to Arch Biosurgery, Inc. include
a total of 27 patents and pending applications in a total of nine jurisdictions, including seven patents and pending applications
in the US. These portfolios cover self-assembling peptides and methods of use thereof, including four issued US patents (US 9,415,084;
US 9,162,005; US 9,789,157; and US 9,339,476) that expire between 2026 and 2034 (absent patent term extension), and one US application
that has been allowed (US Application No. 15/156,020), as well as eight patents that have been either allowed, issued or granted
in foreign jurisdictions.
We have also entered into a license agreement with Massachusetts
Institute of Technology and Versitech Limited (“MIT”) pursuant to which we have been granted exclusive rights under
two portfolios of patents and non-exclusive rights under another three portfolios of patents.
The two portfolios exclusively licensed from MIT include a total
of 23 patents and pending applications drawn to self-assembling peptides and methods of use thereof in a total of nine jurisdictions.
The portfolios include four issued US patents (US 9,511,113; US 9,084,837; US 9,327,010; and US 9,364,513) that expire between
2026 and 2027 (absent patent term extension), as well as twelve patents that have been either allowed, issued or granted in foreign
jurisdictions
.
The three portfolios non-exclusively licensed from MIT include a
number of US and foreign applications, including four issued US patents (US 7,449,180; US 7,846,891; US 7,713,923; and US 8,901,084)
that expire between 2021 and 2027 (absent patent term extension), as well as four patents that have been either allowed, issued
or granted in foreign jurisdictions.
If we lose certain intellectual property rights owned by third
parties and licensed to us, our business could be materially harmed.
We have entered into certain in-license agreements with MIT and
with certain other third parties, and may seek to enter into additional in-license agreements relating to other intellectual property
rights in the future. To the extent we and our product candidates rely heavily on any such in-licensed intellectual property, we
are subject to our and the counterparty’s compliance with the terms of such agreements in order to maintain those rights.
Presently, we, our lead product candidates and our business plans are dependent on the patent and other intellectual property rights
that are licensed to us under our license agreement with MIT. Although that agreement has a durational term through the life of
the licensed patents, it also imposes certain diligence, capital raising, and other obligations on us, our breach of which could
permit MIT to terminate the agreement. Further, we are responsible for all patent prosecution and maintenance fees under that agreement,
and a failure to pay such fees on a timely basis could also entitle MIT to terminate the agreement. Any failure by us to satisfy
our obligations under our license agreement with MIT or any other dispute or other issue relating to that agreement could cause
us to lose some or all of our rights to use certain intellectual property that is material to our business and our lead product
candidates, which would materially harm our product development efforts and could cause our business to fail.
If we infringe or are alleged to infringe the intellectual
property rights of third parties, our business and financial condition could suffer.
Our research, development and commercialization activities, as well
as any product candidates or products resulting from those activities, may infringe or be accused of infringing a patent or other
intellectual property under which we do not hold a license or other rights. Third parties may own or control those patents or other
rights in the U.S. or abroad, and could bring claims against us that would cause us to incur substantial time, expense, and diversion
of management attention. If a patent or other intellectual property infringement suit were brought against us, we could be forced
to stop or delay research, development, manufacturing or sales, if any, of the applicable product or product candidate that is
the subject of the suit. In order to avoid or settle potential claims with respect to any of the patent or other intellectual property
rights of third parties, we may choose or be required to seek a license from a third party and be required to pay license fees
or royalties or both. Any such license may not be available on acceptable terms, or at all. Even if we or our future collaborators
were able to obtain a license, the rights granted to us or them could be non-exclusive, which could result in our competitors gaining
access to the same intellectual property rights and materially negatively affecting the commercialization potential of our planned
products. Ultimately, we could be prevented from commercializing one or more product candidates, or be forced to cease some aspects
of our business operations, if, as a result of actual or threatened infringement claims, we are unable to enter into licenses on
acceptable terms or at all or otherwise settle such claims. Further, if any such claims were successful against us, we could be
forced to pay substantial damages. Any of those results could significantly harm our business, prospects and operations.
Risks Related to Ownership of our Common
Stock
There is not now, and there may not ever be, an active market
for our Common Stock, which trades in the over-the-counter market in low volumes and at volatile prices.
There currently is a limited market for our Common Stock. Although
our Common Stock is quoted on the OTCQB, an over-the-counter quotation system, trading of our Common Stock is extremely limited
and sporadic and generally at very low volumes. Further, the price at which our Common Stock may trade is volatile and we expect
that it will continue to fluctuate significantly in response to various factors, many of which are beyond our control. The stock
market in general, and securities of small-cap companies driven by novel technologies in particular, has experienced extreme price
and volume fluctuations in recent years. Continued market fluctuations could result in further volatility in the price at which
our Common Stock may trade, which could cause its value to decline. To the extent we seek to raise capital in the future through
the issuance of equity, those efforts could be limited or hindered by low and/or volatile market prices for our Common Stock.
We do not now meet the initial listing standards of the Nasdaq Stock
Market or any other national securities exchange. We presently anticipate that our Common Stock will continue to be quoted on the
OTCQB or another over-the-counter quotation system. In those venues, our stockholders may find it difficult to obtain accurate
quotations as to the market value of their shares of our Common Stock, and may find few buyers to purchase their stock and few
market makers to support its price.
A more active market for our Common Stock may never develop. As
a result, investors must bear the economic risk of holding their shares of our Common Stock for an indefinite period of time.
Our Common Stock is a “penny stock.”
The SEC has adopted regulations that generally define “penny
stock” as an equity security that has a market price of less than $5.00 per share, subject to specific exemptions. The market
price of our Common Stock is, and is expected to continue to be in the near term, less than $5.00 per share and is therefore a
“penny stock.” Brokers and dealers effecting transactions in “penny stock” must disclose certain information
concerning the transaction, obtain a written agreement from the purchaser and determine that the purchaser is reasonably suitable
to purchase the securities. Those rules may restrict the ability of brokers or dealers to sell our Common Stock and may affect
the ability of our stockholders to sell their shares of our Common Stock. In addition, if our Common Stock continues to be quoted
on the OTCQB as we expect, then our stockholders may find it difficult to obtain accurate quotations for our stock, and may find
few buyers to purchase our stock and few market makers to support its price.
If we issue additional shares in the future, including issuances
of shares upon exercise of the Series F Warrants, Series E Warrants, and/or the Series D Warrants, our existing stockholders will
be diluted.
Our articles of incorporation authorize the issuance of up to 300,000,000
shares of Common Stock. In connection with the 2017 Financing that closed on February 24, 2017, we issued an aggregate of 10,166,664
shares of our Common Stock, which equaled approximately 7% of the 136,745,712 shares of our Common Stock that were issued and outstanding
immediately prior to the commencement of the 2017 Financing. Upon the closing of the 2017 Financing, we also issued Series F Warrants
to acquire up to an additional 5,591,664 shares of our Common Stock at an initial exercise price of $0.75 per share. As of November
14, 2017, up to 5,591,664 shares may be acquired upon the exercise of the Series F Warrants.
In connection with the 2016 Private Placement Financing that closed
on May 26, 2016, we issued an aggregate of 9,418,334 shares of our Common Stock, which equaled approximately 8% of the 118,592,070
shares of our Common Stock that were issued and outstanding immediately prior to the commencement of the 2016 Private Placement
Financing. Upon the closing of the 2016 Private Placement Financing, we also issued Series E Warrants to acquire up to an additional
7,063,748 shares of our Common Stock at an initial exercise price of $0.4380 per share. As of November 14, 2017, up to 4,214,582
shares may be acquired upon the exercise of the Series E Warrants.
Similarly, in connection with our private placement financing that
concluded on July 2, 2015 (the “
2015 Private Placement Financing
”), we issued an aggregate of 14,390,754 shares
of our Common Stock, which equaled approximately 18% of the 78,766,487 shares of our Common Stock that were issued and outstanding
immediately prior to the commencement of the 2015 Private Placement Financing. Upon the closing of the 2015 Private Placement Financing,
we also issued Series D Warrants to acquire up to an additional 14,390,754 shares of our Common Stock at an initial exercise price
of $0.25 per share. As of November 14, 2017, up to 8,974,389 shares may be acquired upon the exercise of the Series D Warrants.
Additionally, as of November 14, 2017, 4,320,863 shares of Common
Stock were reserved for future issuance under the 2013 Plan, of which 14,634,210 shares are subject to outstanding option awards
granted under the 2013 Plan at exercise prices ranging from $0.17 to $0.72 per share and with a weighted average exercise price
of $0.39 per share, and the numbers issuable under the 2013 Plan will increase by up to 3 million shares on the first business
day of each following fiscal year as set forth in the 2013 Plan. Finally, in addition to the Series F Warrants granted in connection
with the 2017 Financing, the Series E Warrants granted in connection with the 2016 Private Placement Financing, and the Series
D Warrants granted in connection with the 2015 Private Placement Financing, there are currently outstanding warrants to acquire
up to 145,985 shares of our Common Stock. Any future grants of options, warrants or other securities exercisable or convertible
into our Common Stock, or the exercise or conversion of such shares, and any sales of such shares in the market, could have an
adverse effect on the market price of our Common Stock.
In addition to capital raising activities, other possible business
and financial uses for our authorized Common Stock include, without limitation, future stock splits, acquiring other companies,
businesses or products in exchange for shares of Common Stock, issuing shares of our Common Stock to partners in connection with
strategic alliances, attracting and retaining employees by the issuance of additional securities under our various equity compensation
plans, compensating consultants by issuing shares or options to purchase shares of our Common Stock, or other transactions and
corporate purposes that our Board of Directors deems are in the Company’s best interest. By way of example, on (i) August
9, 2016, we issued 225,000 shares of restricted stock and options to purchase up to an additional 375,000 shares of Common Stock
at an exercise price of price of $0.72 per share in connection with our entrance into a consulting agreement with Acorn Management
Partners, LLC (“
Acorn
”) in consideration of the services to be provided under and in accordance with the terms
of such consulting agreement; and (ii) August 6, 2015, we issued an aggregate of 600,000 shares of restricted stock in connection
with our entrance into separate consulting agreements with two investor relations firms, Excelsior Global Advisors LLC and Acorn,
in each case in consideration of the services to be provided under and in accordance with the terms of each consulting agreement.
Additionally, shares of Common Stock could be used for anti-takeover purposes or to delay or prevent changes in control or management
of the Company. We cannot provide assurances that any issuances of Common Stock will be consummated on favorable terms or at all,
that they will enhance stockholder value, or that they will not adversely affect our business or the trading price of our Common
Stock. The issuance of any such shares will reduce the book value per share and may contribute to a reduction in the market price
of the outstanding shares of our Common Stock. If we issue any such additional shares, such issuance will reduce the proportionate
ownership and voting power of all current shareholders. Further, such issuance may result in a change of control of our corporation.
Future sales of our Common Stock or rights to purchase Common
Stock, or the perception that such sales could occur, could cause our stock price to fall.
As noted above under the risk factor entitled, “
We will
need substantial additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate
our product development programs or commercialization efforts and could cause our business to fail
,” as of November
14, 2017, we believe that our current cash on hand will meet our anticipated cash requirements into the fourth quarter of Fiscal
2018. To raise capital, we may sell Common Stock, convertible securities or other equity securities in one or more transactions
at prices and in a manner we determine from time to time. Any such sales of our Common Stock by us or resale of our Common Stock
by our existing stockholders could cause the market price of our Common Stock to decline.
FINRA sales practice requirements may limit a stockholder’s
ability to buy and sell our stock.
In addition to the “penny stock” rules described above,
FINRA has adopted rules that require that, in recommending an investment to a customer, a broker-dealer must have reasonable grounds
for believing that the investment is suitable for that customer. Prior to recommending speculative low priced securities to their
non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial
status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA has indicated its
belief that there is a high probability that speculative low priced securities will not be suitable for at least some customers.
These FINRA requirements make it more difficult for broker-dealers to recommend that at least some of their customers buy our Common
Stock, which may limit the ability of our stockholders to buy and sell our Common Stock and could have an adverse effect on the
market for our shares.
There may be additional risks because we completed a reverse
merger transaction in June 2013.
Additional risks may exist because we completed a “reverse
merger” transaction in June 2013. Securities analysts of major brokerage firms may not provide coverage of the Company because
there may be little incentive to brokerage firms to recommend the purchase of our Common Stock. There may also be increased scrutiny
by the SEC and other government agencies and holders of our securities due to the nature of the transaction, as there has been
increased focus on transactions such as the Merger in recent years. Further, since the Company existed as a “shell company”
under applicable rules of the SEC up until the closing of the Merger on June 26, 2013, there will be certain restrictions and limitations
on the Company going forward relating to any potential future issuances of additional securities to raise funding and compliance
with applicable SEC rules and regulations.
The Company may have material liabilities that were not discovered
before the closing of the Merger.
The Company may have material liabilities that were not discovered
before the consummation of the Merger. We could experience losses as a result of any such unasserted liabilities that are eventually
found to be incurred, which could materially harm our business and financial condition. Although the Merger Agreement contained
customary representations and warranties from the Company concerning its assets, liabilities, financial condition and affairs,
there may be limited or no recourse against the Company’s prior owners or principals in the event those prove to be untrue.
As a result, the stockholders of the Company bear risks relating to any such unknown or unasserted liabilities.
Certain of our directors and officers own a significant percentage
of our capital stock and are able to exercise significant influence over the Company.
Certain of our directors and executive officers own a significant
percentage of our outstanding capital stock. As of November 14, 2017, Dr. Terrence W. Norchi, our President, Chief Executive Officer
and a director, Dr. Avtar Dhillon, the Chairman of our Board of Directors, and James R. Sulat, a director, beneficially own (as
determined under Section 13(d) of the Exchange Act and the rules and regulations thereunder) approximately 18.0% of our shares
of Common Stock. Accordingly, these members of our Board of Directors and management team have substantial voting power to approve
matters requiring stockholder approval, including without limitation the election of directors, and have significant influence
over our affairs. This concentration of ownership could have the effect of delaying or preventing a change in control of our Company,
even if such a change in control would be beneficial to our stockholders.
The elimination of monetary liability against our directors
and officers under Nevada law and the existence of indemnification rights held by our directors, officers and employees may result
in substantial expenditures by us and may discourage lawsuits against our directors, officers and employees.
Our articles of incorporation eliminate the personal liability of
our directors and officers to our Company and our stockholders for damages for breach of fiduciary duty as a director or officer
to the extent permissible under Nevada law. Further, our amended and restated bylaws provide that we are obligated to indemnify
any of our directors or officers to the fullest extent authorized by Nevada law and, subject to certain conditions, advance the
expenses incurred by any director or officer in defending any action, suit or proceeding prior to its final disposition. Those
indemnification obligations could result in our Company incurring substantial expenditures to cover the cost of settlement or damage
awards against our directors or officers, which we may be unable to recoup. These provisions and resultant costs may also discourage
us from bringing a lawsuit against any of our current or former directors or officers for breaches of their fiduciary duties, and
may similarly discourage the filing of derivative litigation by our stockholders against our directors and officers even if such
actions, if successful, might otherwise benefit us or our stockholders.
We are subject to the reporting requirements of federal securities
laws, compliance with which involves significant time, expense and expertise.
We are a public reporting company in the U.S., and, accordingly,
are subject to the information and reporting requirements of the Exchange Act and other federal securities laws, including the
obligations imposed by the Sarbanes-Oxley Act. The costs associated with preparing and filing annual, quarterly and current reports,
proxy statements and other information with the SEC in the ordinary course, as well as preparing and filing audited financial statements,
has caused, and could continue to cause, our operational expenses to remain at higher levels or continue to increase.
Our present management team has limited experience in managing public
companies. It will be time consuming, difficult and costly for our management team to acquire additional expertise and experience
in operating a public company, and to develop and implement the additional internal controls and reporting procedures required
by Sarbanes-Oxley and other applicable securities laws.
Shares of our Common Stock that have not been registered under
federal securities laws are subject to resale restrictions imposed by Rule 144. In addition, any shares of our Common Stock that
are held by affiliates, including any that are registered, will be subject to the resale restrictions of Rule 144.
Rule 144 imposes requirements on us and our stockholders that must
be met in order to effect a sale thereunder. As a result, it will be more difficult for us to raise funding to support our operations
through the sale of debt or equity securities unless we agree to register such securities under the Securities Act, which could
cause us to expend significant additional time and cash resources and which we presently have no intention to pursue. Further,
it may be more difficult for us to compensate our employees and consultants with our securities instead of cash. We were a shell
company prior to the closing of the Merger, and such status could also limit our use of our securities to pay for any acquisitions
we may seek to pursue in the future (although none are currently planned), and could cause the value of our securities to decline.
In addition, any shares held by affiliates, including shares received in any registered offering, will be subject to certain additional
requirements in order to effect a sale of such shares under Rule 144.
We do not intend to pay cash dividends on our capital stock
in the foreseeable future.
We have never declared or paid any dividends on our shares and do
not anticipate paying any such dividends in the foreseeable future. Any future payment of cash dividends would depend on our financial
condition, contractual restrictions, solvency tests imposed by applicable corporate laws, results of operations, anticipated cash
requirements and other factors and will be at the discretion of our Board of Directors.
We are at risk of securities class action litigation that
could result in substantial costs and divert management’s attention and resources.
In the past, securities class action litigation has been brought
against companies following periods of volatility of its securities in the marketplace, particularly following a company’s
initial public offering. Due to the volatility of our stock price, we could be the target of securities litigation in the future.
Securities litigation could result in substantial costs and divert management’s attention and resources.
ITEM 1B. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 2. PROPERTIES
We do not own any real property. In April 2015, we moved our corporate
offices to a property in Framingham, Massachusetts. In July 2017, we entered into a three year operating lease commencing October
1, 2017 and ending on September 30, 2020 at our current location. We are obligated to pay annual rent of $38,400
during the first year, $39,600 during the second year and $42,000 during the third year. We believe our present offices are suitable
for our current and planned near-term operations.
ITEM 3. LEGAL PROCEEDINGS
In the ordinary course of business, we may become a party to legal
proceedings involving various matters. We are unaware of any such legal proceedings presently pending to which we or our subsidiary
is a party or of which any of our property is the subject that management deems to be, individually or in the aggregate, material
to our financial condition or results of operations.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
The accompanying notes are an integral part
of these consolidated financial statements.
The accompanying notes are an integral part
of these consolidated financial statements.
The accompanying notes are an integral part
of these consolidated financial statements.
The accompanying notes are an integral part
of these consolidated financial statements.
Notes to the Consolidated Financial Statements
1.
|
DESCRIPTION OF BUSINESS
|
Arch Therapeutics, Inc., (together with its subsidiary, the “Company”
or “Arch”) was incorporated under the laws of the State of Nevada on September 16, 2009, under the name “Almah,
Inc.”. Effective June 26, 2013, the Company completed a merger (the “Merger”) with Arch Biosurgery, Inc. (formerly
known as Arch Therapeutics, Inc.), a Massachusetts corporation (“ABS”), and Arch Acquisition Corporation (“Merger
Sub”), the Company’s wholly owned subsidiary formed for the purpose of the transaction, pursuant to which Merger Sub
merged with and into ABS and ABS thereby became the wholly owned subsidiary of the Company. As a result of the acquisition of ABS,
the Company abandoned its prior business plan and changed its operations to the business of a biotechnology company. Our principal
offices are located in Framingham, Massachusetts.
For financial reporting purposes, the Merger represented a “reverse
merger”. ABS was deemed to be the accounting acquirer in the transaction and the predecessor of Arch. Consequently, the accumulated
deficit and the historical operations that are reflected in the Company’s consolidated financial statements prior to the
Merger are those of ABS. All share information has been restated to reflect the effects of the Merger. The Company’s financial
information has been consolidated with that of ABS after consummation of the Merger on June 26, 2013, and the historical financial
statements of the Company before the Merger have been replaced with the historical financial statements of ABS before the Merger
in this report.
ABS was incorporated under the laws of the Commonwealth of Massachusetts
on March 6, 2006 as Clear Nano Solutions, Inc. On April 7, 2008, ABS changed its name from Clear Nano Solutions, Inc. to Arch Therapeutics,
Inc. Effective upon the closing of the Merger, ABS changed its name from Arch Therapeutics, Inc. to Arch Biosurgery, Inc.
The Company has generated no operating revenues to date, and is
devoting substantially all of its efforts toward product research and development. To date, the Company has principally raised
capital through debt borrowings, the issuance of convertible debt, and the issuance of units consisting of common stock and warrants.
The Company expects to incur substantial expenses for the foreseeable
future relating to research, development and commercialization of its potential products. However, there can be no assurance that
the Company will be successful in securing additional resources when needed, on terms acceptable to the Company, if at all. Therefore,
there exists substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements
do not include any adjustments related to the recoverability of assets that might be necessary despite this uncertainty.
2.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
The accompanying consolidated financial statements of the Company
have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”).
Basis of Presentation
The consolidated financial statements include the accounts of Arch
Therapeutics, Inc. and its wholly owned subsidiary, Arch Biosurgery, Inc., a biotechnology company. All intercompany accounts and
transactions have been eliminated in consolidation.
The Company is in the development stage and is devoting substantially
all of its efforts to developing technologies, raising capital, establishing customer and vendor relationships, and recruiting
and retaining new employees.
Use of Estimates
Management is required to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial
statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those
estimates.
Recently Issued Accounting Guidance
Accounting Standards Update (ASU) 2016-15, “Statement of Cash
Flows (Topic 230) Classification of Certain Cash Receipts and Payments” was issued by the Financial Accounting Standards
Board (FASB) in August 2016. The purpose of this amendment is to address eight specific cash flow issues with the objective of
reducing the existing diversity in practice. The amendments in this Update are effective for public business entities for fiscal
years, and for interim periods within those fiscal years, beginning after December 15, 2017. Early adoption is permitted. The Company
does not believe that this guidance will have a material impact on its consolidated results of operations, financial position or
disclosures.
ASU 2016-09, “Compensation—Stock Compensation (Topic
718) Improvements to Employee Share-Based Payment Accounting” was issued by the FASB in March 2016. The purpose of this amendment
is to simplify several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification
of awards as either equity or liabilities, and classification on the statement of cash flows. The amendments in this Update are
effective for public business entities for fiscal years, and for interim periods within those fiscal years, beginning after December
15, 2016. Early adoption is permitted. The Company does not believe that this guidance will have a material impact on its consolidated
results of operations, financial position or disclosures.
ASU 2016-02, “Leases (Topic 842)” was issued by the
FASB in February 2016. The purpose of this amendment requires the recognition of lease assets and lease liabilities by lessees
for those leases previously classified as operating leases. The amendments in this Update are effective for public business entities
for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2018. Early adoption is permitted.
The Company does not believe that this guidance will have a material impact on its consolidated results of operations, financial
position or disclosures.
ASU 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” was
issued by the FASB in August 2014. The primary purpose of the ASU is to provide guidance in GAAP about management’s responsibility
to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related
footnote disclosures. The amendments should reduce diversity in the timing and content of footnote disclosure. ASU 2014-15 is effective
for the annual period ending after December 15, 2016, and for the annual periods and interim periods thereafter. Early adoption
is permitted.
The Company adopted ASU 2014-15 during our first quarter of fiscal year 2017, which
had no impact on our consolidated financial statements, and will apply the new guidance in future periods.
ASU 2014-12, “Compensation-Stock Compensation (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” was issued by the FASB in June 2014. ASU 2014-12 requires that compensation cost should be
recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation
cost attributable to the period(s) for which the requisite service has already been rendered. ASU 2014-12 is effective for public
business entities for annual periods and interim periods within the annual periods beginning after December 15, 2015. Early adoption
is permitted. The Company adopted ASU 2014-12 during the first quarter of fiscal year 2017,
which
had no impact on our consolidated financial statements, and will apply the new guidance in future periods.
Cash
The Company considers all highly liquid investments with an original
maturity of three months or less to be cash equivalents. The Company had no cash equivalents as of September 30, 2017 and September
30, 2016.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentration
of credit risk consist primarily of cash. The Company maintains its cash in bank deposits accounts, which, at times, may exceed
federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to
any significant credit risk on cash.
Deferred Offering Costs
Deferred Offering Costs consist of fees and expenses incurred in
connection with the public offering and sale of the Company’s common stock, including legal, accounting, printing and other
related expenses. These costs are netted against the proceeds received as a reduction to additional paid-in capital.
Property and Equipment
Property and equipment are recorded at cost and depreciated using
the straight-line method over the estimated useful life of the related asset. Upon sale or retirement, the cost and accumulated
depreciation are eliminated from their respective accounts, and the resulting gain or loss is included in income or loss for the
period. Repair and maintenance expenditures are charged to expense as incurred.
Impairment of Long-Lived Assets
Long-lived assets are reviewed for impairment when circumstances
indicate the carrying value of an asset may not be recoverable in accordance with ASC 360,
Property, Plant and Equipment
.
For assets that are to be held and used, impairment is recognized when the estimated undiscounted cash flows associated with the
asset or group of assets is less than their carrying value. If impairment exists, an adjustment is made to write the asset down
to its fair value, and a loss is recorded as the difference between the carrying value and fair value. Fair values are determined
based on quoted market values, discounted cash flows or internal and external appraisals, as applicable. Assets to be disposed
of are carried at the lower of carrying value or estimated net realizable value. For the years ended September 30, 2017 and 2016
there has not been any impairment of long-lived assets.
Convertible Debt
The Company records a discount to convertible notes for the intrinsic
value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common
stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Debt discounts under
these arrangements are amortized to noncash interest expense using the effective interest rate method over the term of the related
debt to their date of maturity. If a security or instrument becomes convertible only upon the occurrence of a future event outside
the control of the Company, or, is convertible from inception, but contains conversion terms that change upon the occurrence of
a future event, then any contingent beneficial conversion feature is measured and recognized when the triggering event occurs and
contingency has been resolved.
Income Taxes
In accordance with ASC 740,
Income Taxes
, the Company
recognizes deferred tax assets and liabilities for the expected future tax consequences or events that have been included in the
Company’s consolidated financial statements and/or tax returns. Deferred tax assets and liabilities are based upon the differences
between the financial statement carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards
using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. Deferred tax assets
are reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not
be realized.
The Company provides reserves for potential payments of tax to various
tax authorities related to uncertain tax positions when management determines that it is probable that a loss will be incurred
related to these matters and the amount of the loss is reasonably determinable. The Company has no reserves related to uncertain
tax positions as of September 30, 2017 and September 30, 2016.
Research and Development
The Company expenses internal and external research and development
costs, including costs of funded research and development arrangements, in the period incurred.
Accounting for Stock-Based Compensation
The Company accounts for employee stock-based compensation in accordance
with the guidance of FASB ASC Topic 718,
Compensation-Stock Compensation
(“FASB ASC Topic 718”), which requires
all share-based payments to employees, including grants of employee stock options, to be recognized in the consolidated financial
statements based on their fair values. The Company accounts for non-employee stock-based compensation in accordance with the guidance
of FASB ASC Topic 505,
Equity
(“FASB ASC Topic 505”), which requires that companies recognize compensation expense
based on the estimated fair value of options granted to non-employees over their vesting period, which is generally the period
during which services are rendered by such non-employees. FASB ASC Topic 505 requires the Company to re-measure the fair value
of stock options issued to non- employee at each reporting period during the vesting period or until services are complete.
In accordance with FASB ASC Topic 718, the Company has elected to
use the Black-Scholes option pricing model to determine the fair value of options granted and recognizes the compensation cost
of share-based awards on a straight-line basis over the vesting period of the award.
The determination of the fair value of share-based payment awards
utilizing the Black-Scholes model is affected by the fair value of the common stock and a number of other assumptions, including
expected volatility, expected life, risk-free interest rate and expected dividends. The Company does not have a sufficient history
of market prices of the common stock, and as such volatility is estimated in accordance with ASC 718-10-S99 Staff Accounting Bulletin
(“SAB”) No. 107,
Share-Based Payment
(“SAB No. 107”), using historical volatilities of similar public
entities. The life term for awards uses simplified method for all “plain vanilla” options, as defined in ASC 718-10-S99
and the contractual term for all other employee and non-employee awards. The risk-free interest rate assumption is based on observed
interest rates appropriate for the terms of our awards. The dividend yield assumption is based on history and the expectation of
paying no dividends. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. Stock-based compensation expense, when recognized in the consolidated financial statements,
is based on awards that are ultimately expected to vest.
Fair Value Measurements
The Company measures both financial and nonfinancial
assets and liabilities in accordance with FASB ASC Topic 820,
Fair Value Measurements and Disclosures
, including those
that are recognized or disclosed in the consolidated financial statements at fair value on a recurring basis. The standard
created a fair value hierarchy which prioritizes the inputs to valuation techniques used to measure fair value into three
broad levels as follows: Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability,
either directly or indirectly; and Level 3 inputs are unobservable inputs that reflect the Company’s own views about
the assumptions market participants would use in pricing the asset or liability.
At September 30, 2017 and September 30, 2016, the carrying amounts
of cash, accounts payable, accrued expenses and other liabilities, and convertible notes approximate fair value because of their
short-term nature. The fair value of note payable, which is influenced by interest rates and the Company’s liquidity, approximates
carrying value.
Derivative Liabilities
The Company accounts for its warrants and other derivative financial
instruments as either equity or liabilities based upon the characteristics and provisions of each instrument, in accordance with
FASB ASC Topic 815, Derivatives and Hedging. Warrants classified as equity are recorded at fair value as of the date of issuance
on the Company’s consolidated balance sheets and no further adjustments to their valuation are made. Warrants classified
as derivative liabilities and other derivative financial instruments that require separate accounting as liabilities are recorded
on the Company’s consolidated balance sheets at their fair value on the date of issuance and will be revalued on each subsequent
balance sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods
recorded as other income or expense. Management estimates the fair value of these liabilities using option pricing models and assumptions
that are based on the individual characteristics of the warrants or instruments on the valuation date, as well as assumptions for
future financings, expected volatility, expected life, yield, and risk-free interest rate.
Subsequent Events
The Company evaluated all events or transactions that occurred commencing
from October 1, 2017 and ending on November 14, 2017 the date which these consolidated financial statements were issued. The Company
disclosed material subsequent events in Note 14.
Going Concern Basis of Accounting
As reflected in the consolidated financial
statements, the Company has an accumulated deficit, has suffered significant net losses and negative cash flows from operations,
has not generated operating revenues, and has limited working capital. The continuation of our business as a going concern is dependent
upon raising additional capital and eventually attaining and maintaining profitable operations. In particular, as of September
30, 2017, the Company will be required to raise additional capital, obtain alternative means of financial support, or both, in
order to continue to fund operations, and therefore there is substantial doubt about our ability to continue as a going concern.
The Company expects to incur substantial expenses into the foreseeable future for the research, development and commercialization
of its potential products. In addition, the Company will require additional financing in order to seek to license or acquire new
assets, research and develop any potential patents and the related compounds, and obtain any further intellectual property that
the Company may seek to acquire. Historically, the Company has principally funded operations through debt borrowings, the issuance
of convertible debt, and the issuance of units consisting of common stock and warrants. Provisions in the 2017 SPA restricts the Company’s ability to effect or enter into an agreement to effect
any issuance by the Company or any of its subsidiaries of Common Stock or securities convertible, exercisable or exchangeable for
Common Stock (or a combination of units thereof) involving a Variable Rate Transaction (as defined in the 2017 SPA) including,
but not limited to, an equity line of credit or “At-the-Market” financing facility until the three lead investors in
the 2017 Financing collectively own less than 20% of the Series F Warrants purchased by them pursuant to the 2017 SPA.
The accompanying consolidated financial statements
have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and
the settlement of liabilities and commitments in the normal course of business. The consolidated financial statements do not include
any adjustments that might result from this uncertainty.
3.
|
PROPERTY AND EQUIPMENT
|
At September 30, 2017 and September 30, 2016,
property and equipment consisted of:
|
|
Estimated
Useful Life
|
|
September 30,
2017
|
|
|
September 30,
2016
|
|
|
|
|
|
|
|
|
|
|
Computer equipment
|
|
3 years
|
|
$
|
8,686
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Furniture and fixtures
|
|
5 years
|
|
|
2,925
|
|
|
|
2,925
|
|
|
|
|
|
|
|
|
|
|
|
|
Lab equipment
|
|
5 years
|
|
|
1,000
|
|
|
|
1,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,611
|
|
|
|
3,925
|
|
|
|
|
|
|
|
|
|
|
|
|
Less – accumulated depreciation
|
|
|
|
|
5,323
|
|
|
|
3,925
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
|
$
|
7,188
|
|
|
$
|
-
|
|
For the years ended September 30, 2017 and 2016 depreciation expense
recorded was $1,498 and $0, respectively.
The principal components of the Company's net
deferred tax assets consisted of the following at September 30:
|
|
2017
|
|
|
2016
|
|
Net operating loss carryforwards
|
|
$
|
7,129,736
|
|
|
$
|
5,424,530
|
|
Capitalized expenditures
|
|
|
1,511,187
|
|
|
|
1,104,928
|
|
Research and experimentation credit carryforwards
|
|
|
632,659
|
|
|
|
458,417
|
|
Stock based compensation
|
|
|
2,370,477
|
|
|
|
1,463,474
|
|
Property and Equipment
|
|
|
1,488
|
|
|
|
1,578
|
|
Accrued expenses
|
|
|
20,100
|
|
|
|
171,083
|
|
Gross deferred tax assets
|
|
|
11,665,647
|
|
|
|
8,624,010
|
|
Deferred tax asset valuation allowance
|
|
|
(11,665,647
|
)
|
|
|
(8,624,010
|
)
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
$
|
-
|
|
|
$
|
-
|
|
As of September 30, 2017 and 2016, the Company had federal net operating
loss carryforwards of approximately $17,960,000 and $13,675,000, respectively, which may be available to offset future taxable
income and which would begin to expire in 2026. As of September 30, 2017 and 2016, the Company had federal research and experimentation
credit carryforwards of $526,957 and $380,982, respectively, which may be available to offset future income tax liabilities and
which would begin to expire in 2029.
As of September 30, 2017 and 2016, the Company had state net operating
loss carryforwards of approximately $16,771,000 and $12,814,000, respectively, which may be available to offset future taxable
income and which would begin to expire in 2018. As of September 30, 2017 and 2016, the Company had state research and experimentation
credit carryforwards of $162,000 and $119,000, respectively, which may be able to offset future income tax liabilities and which
would begin to expire in 2023.
As the Company has not yet achieved profitable operations, management
believes the tax benefits as of September 30, 2017 and 2016 did not satisfy the realization criteria set forth in FASB ASC Topic
740, Income Taxes, and therefore has recorded a valuation allowance for the entire deferred tax asset. The valuation allowance
increased in 2017 and 2016 by approximately $3,041,000 and $2,767,000, respectively. The Company’s effective income tax rate
differed from the federal statutory rate due to state taxes and the Company’s full valuation allowance, the latter of which
reduced the Company’s effective federal income tax rate to zero.
The Company experienced an ownership change as a result
of the Merger described in Note 1, causing a limitation on the annual use of the net operating loss carryforwards, which are subject
to a substantial annual limitation due to the ownership change limitations set forth in Internal Revenue Code Section 382 and similar
state provisions.
As of September 30, 2017, the Company is open to examination in
the U.S. federal and certain state jurisdictions for tax years ended September 30, 2017, 2016, 2015, and 2014.
|
5.
|
2014 PRIVATE PLACEMENT FINANCING
|
On January 30, 2014, the Company entered into a Securities Purchase
Agreement (the “
Securities Purchase Agreement
”) with nine separate accredited investors (“
2014 Investors
”)
providing for the issuance and sale by the Company to the 2014 Investors, in a private placement, of an aggregate of 11,400,000
shares of Common Stock (collectively, the “
2014 Shares
”) at a purchase price of $0.25 per share and three series
of warrants, the Series A warrants, the Series B warrants and the Series C warrants, to purchase up to an aggregate of 34,200,000
shares of the Company’s Common Stock (collectively, the “
2014 Warrants
,” and the shares issuable upon
exercise of the 2014 Warrants, collectively, the “
2014 Warrant Shares
”), for aggregate gross proceeds to the
Company of approximately $2,850,000 (the “
2014 Private Placement Financing
”).
Upon the closing of the 2014 Private Placement Financing on February
4, 2014 (the “
Closing Date
”), the Company entered into a registration rights agreement (the “
2014 Registration
Rights Agreement
”) with the 2014 Investors, pursuant to which the Company became obligated, subject to certain conditions,
to file with the SEC on or before March 21, 2014 one or more registration statements to register for resale under the Securities
Act of 1933, as amended (the “
Securities Act
”), (i) the 2014 Shares and the 2014 Warrant Shares, plus (ii) an
additional number of shares of Common Stock equal to 33% of the total number of 2014 Shares and 2014 Warrant Shares, to account
for adjustments, if any, to the number of 2014 Warrant Shares issuable pursuant to the terms of the 2014 Warrants (the securities
set forth in this clause (ii), the “
Additional Shares
”). Under the terms of the 2014 Registration Rights Agreement,
the Company was permitted to reduce the number of shares covered by a registration statement if such reduction is required by the
SEC as a condition for permitting such registration statement to become effective and treated as a resale registration statement
(the “
Cutback Provisions
”). In response to comments received from the SEC and in accordance with the terms of
the 2014 Registration Rights Agreement, the Company reduced the number of shares included in its draft resale registration statement
(the “
2014 S-1
”) by the number of Additional Shares. The Company’s failure to satisfy certain other obligations
and deadlines set forth in the 2014 Registration Rights Agreement may subject the Company to payment of monetary penalties as discussed
below. The resale registration statement was declared effective on July 2, 2014. As described below, in the event that we fail
to comply with certain requirements in the 2014 Registration Rights Agreement, we may be required to pay liquidated damages to
the investors.
The 2014 Registration Rights Agreement also obligated the Company
to register the resale of all securities covered by the 2014 Registration Rights Agreement on a short-form registration statement
on Form S-3 as soon as the Company becomes eligible to use Form S-3. On October 31, 2016, the Company filed a resale registration
statement on Form S-3 (the “
2014 S-3
”) to register the remaining securities covered by the 2014 Registration
Rights Agreement, and the 2014 S-3 was declared effective on November 23, 2016. Pursuant to Rule 429 promulgated under the Securities
Act, the 2014 S-3 contained a combined prospectus that covered the securities that remained unsold under the 2014 S-1 and also
registered those same securities under the 2014 S-3. Under Rule 429, the 2014 S-3 also constituted a post-effective amendment to
the 2014 S-1, which became effective on the date that the 2014 S-3 was declared effective.
The 2014 Warrants were exercisable immediately upon issuance. The
Series A warrants had an initial exercise price of $0.30 per share and expire five years from the date of their issuance. The Series
B warrants had an initial exercise price of $0.35 per share and expired on the earlier of 12 months after their issuance date or
six months after the first date on which the resale of all Registrable Securities (as defined in the 2014 Registration Rights Agreement)
is covered by one or more effective registration statements, which occurred on July 2, 2014 (the “
2014 Registration Statement
Effective Date
”). The Series B warrants expired on January 2, 2015. The Series C warrants had an initial exercise price
of $0.40 per share and an initial expiration on the earlier of 18 months after their issuance date or nine months after the 2014
Registration Statement Effective Date. As described below, the term of the Series C Warrants was extended to 5:00 p.m., New York
time, on July 2, 2016 and, prior to such expiration date, all 11,400,000 shares underlying the Series C Warrants were exercised.
The number of shares of the Company’s Common Stock into which each of the 2014 Warrants is exercisable and the exercise price
therefore were subject to adjustment as set forth in the 2014 Warrants, including, without limitation, adjustment to both the exercise
price of the 2014 Warrants in the event of certain subsequent issuances and sales of shares of the Company’s Common Stock
(or securities convertible or exercisable into shares of Common Stock) at a price per share lower than the then-effective exercise
price of the 2014 Warrants, in which case the per share exercise price of the 2014 Warrants would be adjusted to equal such lower
price per share and the number of shares issuable upon exercise of the 2014 Warrants would be adjusted accordingly so that the
aggregate exercise price upon full exercise of the 2014 Warrants immediately before and immediately after such per share exercise
price adjustment were equal (the “
Anti-Dilution Provisions
”). The 2014 Warrants are also subject to customary
adjustments in the event of stock dividends and splits, subsequent rights offerings and pro rata distributions to the Company’s
common stockholders, and provide that they shall not be exercisable in the event and to the extent that the exercise thereof would
result in the holder of the Warrant or any of its affiliates beneficially would then own more than 4.9% of the Company’s
Common Stock. The Company may be required to make certain payments to the 2014 Investors under certain circumstances in the future
pursuant to the terms of the Securities Purchase Agreement and the 2014 Registration Rights Agreement. These potential future payments
include: (a) potential partial damages for failure to register the Common Stock issued or issuable upon exercise of 2014 Warrants
in a cash amount equal to 1% of the price paid to the Company by each investor in the 2014 Private Placement Financing on the date
of and on each 30-day anniversary of such failure until the cure thereof; (b) amounts payable if the Company and its transfer agent
fail to timely remove certain restrictive legends from certificates representing shares of Common Stock issued in the 2014 Private
Placement Financing or issuable upon exercise of the 2014 Warrants; (c) expense reimbursement for the lead investor in the 2014
Private Placement Financing; and (d) payments in respect of claims for which the Company provides indemnification. There is no
cap to the potential consideration.
On December 1, 2014, the Company entered into an agreement with
Cranshire Capital Master Fund, Ltd. (“
Cranshire
”), which was the lead investor in the 2014 Private Placement
Financing, to amend certain provisions of the 2014 Warrants (the “
December 2014 Amendment
”). Under the terms
of the December 2014 Amendment, the 2014 Warrants were amended to (i) reduce the exercise price of the Series B Warrants from $0.35
to $0.20; (ii) reduce the exercise price of the Series C Warrants from $0.40 to $0.20; and (iii) clarify that each series of 2014
Warrants may be amended without having to amend all three series of 2014 Warrants. The number of shares of the Company’s
Common Stock, which may be purchased from the Company upon exercise of each 2014 Warrant, remained unchanged. In conjunction with
the December 2014 Amendment, the Company recognized a loss on the modification of 2014 Warrants in the amount of $1,300,170, which
was determined using Monte Carlo Simulation valuation model.
As of December 2, 2014, Series B Warrants had been exercised for
an aggregate issuance of 4,000,000 shares of the Company’s Common Stock resulting in gross proceeds to the Company of $800,000.
In conjunction with the exercise of the Series B Warrants, their corresponding fair value at the exercise dates of $224,000 were
extinguished from the derivative liabilities balance.
On March 13, 2015, the Company issued unsecured 8% Convertible Notes
in the aggregate principal amount of $750,000 - See footnote 6. The Company’s issuance of the Notes triggered the Anti-Dilution
Provisions of the Series A Warrants and, as a result, the exercise price of the Series A Warrants was reduced to $0.20 per share
and the aggregate number of shares issuable under the Series A Warrants increased by 5,700,000 shares from 11,400,000 shares to
17,100,000 shares. In addition, on March 13, 2015 and May 30, 2015, respectively the expiration date of the Series C Warrants was
extended to June 2, 2015 and July 2, 2015, respectively. In conjunction with the March 13, 2015 amendment, the Company recognized
a loss on the modification of warrants in the amount of $624,016, which was determined using Monte Carlo Simulation.
Prior to June 22, 2015, Series C Warrants had been exercised for
an aggregate issuance of 2,255,000 shares of the Company’s common stock resulting in gross proceeds to the Company of $451,000.
In conjunction with the exercise of the Series C Warrants, their corresponding fair value at the exercise dates of $75,321 were
extinguished from the derivative liabilities balance and recognized as a gain in the Company’s statements of operations.
On June 22, 2015 the Company entered into an amendment to the Series
A Warrants and Series C Warrants to purchase Common Stock (the “June 2015 Amendment”), with Cranshire, to (i) delete
the Anti-Dilution Provisions in the Series A Warrants and Series C Warrants; and (ii) extend the expiration date of the Series
C Warrants from to 5:00 p.m., New York time, on July 2, 2015 to 5:00 p.m., New York time, on July 2, 2016. In consideration of
Cranshire’s entrance into the June 2015 Amendment (and for no additional consideration), the Company agreed to issue to the
holders of the 2014 Warrants up to 570,000 shares of Company’s Common Stock subject to the delivery by each such holder of
an investor certificate to the Company (such shares of Common Stock, the “Inducement Shares”). All 570,000 Inducement
Shares have been issued. In conjunction with the modifications to the Series A and Series C Warrants in the June 2015 Amendment,
the Company recognized a gain on modification of warrants, net of Inducement Shares, in the amount of $927,373 which was determined
using the Black Scholes model. As of June 22, 2015, the Company determined that its Series A and C Warrants were eligible for equity
classification due to the elimination of the full ratchet anti-dilution provision. As a result, as of June 22, 2015, the then-current
value of the derivative liabilities of $3,263,753 was reclassified as equity within the Company’s consolidated financial
statements.
During the year ended September 30, 2017, Series A Warrants had
been exercised on a cash basis for an aggregate issuance of 1,100,000 shares of the Company’s common stock, resulting in
gross proceeds to the Company of $220,000. During the year ended September 30, 2016, Series C Warrants had been exercised on a cash basis for an aggregate
issuance of 3,400,000 shares of the Company’s Common stock, respectively, resulting in gross proceeds to the Company of $680,000.
During the year ended September 30, 2016, Series A Warrants had been exercised on a cash basis for an aggregate issuance of 4,300,000
shares of the Company’s common stock, resulting in gross proceeds to the Company of $860,000. In addition 3,925,000 Series
A Warrants were exercised on a cashless basis resulting in an issuance of 2,333,559 shares of the Company’s common stock.
|
6.
|
2015 PRIVATE PLACEMENT FINANCING
|
Beginning June 22, 2015 and through June 30, 2015, the Company entered
into a series of substantially similar subscription agreements (each a “
Subscription Agreement
”) with 20 accredited
investors (collectively, the “
2015 Investors
”) providing for the issuance and sale by the Company to the 2015
Investors, in a private placement, of an aggregate of 14,390,754 Units (“
Unit
”) at a purchase price of $0.22
per Unit (the “
2015 Private Placement Financing
”). Each Unit consisted of a share of Common Stock (the “
2015
Shares
”) and a Series D Warrant to purchase a share of Common Stock at an exercise price of $0.25 per share at any time
prior to the fifth anniversary of the issuance date of the Series D Warrant (the “
Series D Warrants
,” and the
shares issuable upon exercise of the Series D Warrants, collectively, the “2015 Warrant Shares”). The Company did not
engage any underwriter or placement agent in connection with the 2015 Private Placement Financing, and the aggregate gross proceeds
raised by the Company in the 2015 Private Placement Financing totaled approximately $3,200,000.
The Company’s obligation to issue and sell the 2015 Shares
and the Series D Warrants and the corresponding obligation of the 2015 Investors to purchase such 2015 Shares and Series D Warrants
were subject to a number of conditions precedent including, but not limited to, the amendment of the Company’s Series A Warrants
and Series C Warrants to delete certain of the anti-dilution provisions contained therein, as described in Note 5, 2014 Private
Placement Financing, and other customary closing conditions. The conditions precedent were satisfied June 30, 2015 (the “
Initial
Closing Date
”), and the Company conducted an initial closing (the “
Initial Closing
”) pursuant to which
it sold and 19 of the 2015 Investors (the “
Initial Investors
”) purchased 13,936,367 Units at an aggregate purchase
price of $3,066,000. On July 2, 2015, the Company conducted a second closing (the “
Second Closing
” and together
with the Initial Closing, the “
Closings
”) pursuant to which it sold and one of the 2015 Investors purchased
454,387 Units at an aggregate purchase price of $100,000.
On the Initial Closing Date, the Company entered into a registration
rights agreement with the Initial Investors (the “
2015 Registration Rights Agreement
”), pursuant to which the
Company was obligated, subject to certain conditions, to file with the Securities and Exchange Commission within 90 days after
the closing of the 2015 Private Placement Financing one or more registration statements (any such registration statement, a “
Resale
Registration Statement
”) to register the 2015 Shares and the 2015 Warrant Shares for resale under the Securities Act.
The remaining 2015 Investor became a party to the 2015 Registration Rights Agreement upon the consummation of the Second Closing.
The Company’s failure to satisfy certain filing and effectiveness deadlines with respect to a Resale Registration Statement
and certain other requirements set forth in the 2015 Registration Rights Agreement may subject the Company to payment of monetary
penalties. On October 27, 2015, we received from the SEC a Notice of Effectiveness of our Registration Statement related to the
2015 Private Placement Financing (the “
2015 S-1
”) which satisfied some of our obligation to register these securities
with the SEC.
The 2015 Registration Rights Agreement also obligated the Company
to register the resale of all securities covered by the 2015 Registration Rights Agreement on a short-form registration statement
on Form S-3 as soon as the Company becomes eligible to use Form S-3. On October 31, 2016, the Company filed a resale registration
statement on Form S-3 (the “
2015 S-3
”) to register the remaining securities covered by the 2015 Registration
Rights Agreement, and the 2015 S-3 was declared effective on November 23, 2016. Pursuant to Rule 429 promulgated under the Securities
Act, the 2015 S-3 contained a combined prospectus that covered the securities that remained unsold under the 2015 S-1 and also
registered those same securities under the 2015 S-3. Under Rule 429, the 2015 S-3 also constituted a post-effective amendment to
the 2015 S-1, which became effective on the date that the 2015 S-3 was declared effective.
Following each Closing, each 2015 Investor was also issued Series
D Warrants to purchase shares of the Company’s Common Stock up to 100% of the 2015 Shares purchased by such 2015 Investor
under such 2015 Investor’s Subscription Agreement. The Series D Warrants have an exercise price of $0.25 per share, are exercisable
immediately after their issuance and have a term of exercise equal to five years after their issuance date. The number of shares
of the Company’s Common Stock into which each of the Series D Warrants is exercisable and the exercise price therefore are
subject to adjustment, as set forth in the Series D Warrants, including adjustments for stock subdivisions or combinations (by
any stock split, stock dividend, recapitalization, reorganization, scheme, arrangement or otherwise). In addition, at any time
during the term of the Series D Warrants, the Company may reduce the then-current exercise price to any amount and for any period
of time deemed appropriate by the Board of the Company.
During the year ended September 30,2017, Series D Warrants had been
exercised on a cash basis for an aggregate issuance of 1,750,001 shares of the Company’s Common stock resulting in gross
proceeds to the Company of $437,500. During the year ended September 30, 2016, Series D Warrants had been exercised on a cash basis for an aggregate
issuance of 3,439,091 shares of the Company’s Common stock resulting in gross proceeds to the Company of $859,773.
Common Stock
At the June 30, 2015 Initial Closing Date of the 2015 Private Placement
Financing, the Company issued 13,936,367 shares of Common Stock. On July 2, 2015, the Company conducted the Second Closing pursuant
to which it sold and one of the 2015 Investors purchased 454,387 shares of Common Stock.
Equity Value of Warrants
The Company accounted for the Series D Warrants relating to the
aforementioned 2015 Private Placement Financing in accordance with ASC 815-40,
Derivatives and Hedging
. Because the Series
D Warrants are indexed to the Company’s stock, they are classified within stockholders’ equity in the accompanying
consolidated financial statements.
|
7.
|
2016 PRIVATE PLACEMENT FINANCING
|
Beginning May 24, 2016 and through May 26, 2016, we
entered into a series of substantially similar subscription agreements (each a “
2016 Subscription
Agreement
”) with 18 accredited investors (collectively, the “
2016 Investors
”) providing for the
issuance and sale by the Company to the 2016 Investors, in a private placement, of an aggregate of 9,418,334 Units at a
purchase price of $0.36 per Unit (the “
2016 Private Placement Financing
”). Each Unit consisted of a share
of Common Stock, and a Series E Warrant to purchase 0.75 shares of Common Stock at an exercise price of $0.4380 per share at
any time prior to the fifth anniversary of the issuance date of the Series E Warrant (the “
Series E
Warrants
,” and the shares issuable upon exercise of the Series E Warrants, collectively, the “
Series E
Warrant Shares
”). The exercise price of the Series E Warrants was set to equal the closing price of our Common
Stock on the date of their issuance (May 26, 2016), which was $0.4380, and therefore the Series E Warrants were not issued at
a discount to the market price of our Common Stock as of such date. The gross proceeds to Arch were approximately $3.4
million before deducting financing costs of approximately $281,000.
The number of shares of Common Stock into which each of the Series
E Warrants is exercisable and the exercise price therefor are subject to adjustment as set forth in the Series E Warrants, including
adjustments for stock subdivisions or combinations (by any stock split, stock dividend, recapitalization, reorganization, scheme,
arrangement or otherwise). In addition, (i) at any time during the term of the Series E Warrants, we may reduce the then-current
exercise price to any amount and for any period of time deemed appropriate by our Board of Directors (the “
Board
“);
and (ii) certain of the Series E Warrants provide that they shall not be exercisable in the event and to the extent that the exercise
thereof would result in the holder of the Series E Warrant, together with its affiliates and any other persons whose beneficial
ownership of Common Stock would be aggregated with the holder’s, would be deemed to beneficially own more than 4.99% of the
Common Stock;
provided, however
, the holder, upon notice to us, may increase or decrease the ownership limitation,
provided
that
any increase is limited to a maximum of 9.99% of the Company’s Common Stock, and any increase in the ownership limitation
will not become effective until the 61
st
day after delivery of such notice.
We engaged Maxim Group LLC (“Maxim”) as our exclusive
institutional investor placement agent in connection with the 2016 Private Placement Financing, and in consideration for the services
provided by it, Maxim was entitled to receive cash fees equal to 8.2% of the gross proceeds received by us from certain institutional
investors participating in the 2016 Private Placement Financing (the “
Maxim Investors
”), as well as reimbursement
for all reasonable expenses incurred by it in connection with its engagement. We received gross proceeds of approximately $3,390,600
in the aggregate, of which approximately $2,084,000 was attributable to the Maxim Investors, resulting in a fee of approximately
$170,888.
On May 26, 2016, we entered into a registration rights agreement
with the 2016 Investors (the “
2016 Registration Rights Agreement
”), pursuant to which we became obligated, subject
to certain conditions, to file with the Securities and Exchange Commission (the “
SEC
”) within 45 days after
the closing of the 2016 Private Placement Financing one or more registration statements (the “
2016 S-1
”) to
register the shares of Common Stock issued in the Closings and the Series E Warrant Shares for resale under the Securities Act
of 1933, as amended (the “
Securities Act
”). As a result, we registered for resale under the 2016 S-1 an aggregate
of 16,482,082 shares of Common Stock, representing the 9,418,334 shares issued at the closing of the 2016 Private Placement Financing
and the 7,063,748 shares underlying the Series E Warrants. On July 13, 2016, we received from the SEC a Notice of Effectiveness
of the 2016 S-1, which satisfied some of our obligation to register these securities with the SEC.
The 2016 Registration Rights Agreement also obligated the Company
to register the resale of all securities covered by the 2016 Registration Rights Agreement on a short-form registration statement
on Form S-3 as soon as the Company becomes eligible to use Form S-3. On October 31, 2016, the Company filed a resale registration
statement on Form S-3 (the “
2016 S-3
”) to register the remaining securities covered by the 2016 Registration
Rights Agreement, and the 2016 S-3 was declared effective on November 23, 2016. Pursuant to Rule 429 promulgated under the Securities
Act, the 2016 S-3 contained a combined prospectus that covered the securities that remained unsold under the 2016 S-1 and also
registered those same securities under the 2016 S-3. Under Rule 429, the 2016 S-3 also constituted a post-effective amendment to
the 2016 S-1, which became effective on the date that the 2016 S-3 was declared effective.
Following the Closing, each 2016 Investor was also issued Series
E Warrants to purchase shares of the Company’s Common Stock up to 75% of the 2016 Shares purchased by such 2016 Investor
under such 2016 Investor’s Subscription Agreement. The Series E Warrants have an exercise price of $0.438 per share, are
exercisable immediately after their issuance and have a term of exercise equal to five years after their issuance date. The number
of shares of the Company’s Common Stock into which each of the Series E Warrants is exercisable and the exercise price therefore
are subject to adjustment, as set forth in the Series E Warrants, including adjustments for stock subdivisions or combinations
(by any stock split, stock dividend, recapitalization, reorganization, scheme, arrangement or otherwise). In addition, at anytime
during the term of the Series E Warrants, the Company may reduce the then-current exercise price to any amount and for any period
of time deemed appropriate by the Board of the Company.
During the year ended September 30, 2017, Series E Warrants had
been exercised on a cash basis for an aggregate issuance of 2,128,741 shares of the Company’s Common stock resulting in gross
proceeds to the Company of $932,388. During the year ended September 30, 2016, Series E Warrants had been exercised on a cash basis for an aggregate
issuance of 705,425 shares of the Company’s Common stock resulting in gross proceeds to the Company of $308,976.
Common Stock
At May 26, 2016, the Closing Date of the 2016 Private Placement
Financing, the Company issued 9,418,334 shares of Common Stock.
Equity Value of Warrants
The Company accounted for the Series E Warrants relating to the
aforementioned 2016 Private Placement Financing in accordance with ASC 815-40,
Derivatives and Hedging
. Because the Series
E Warrants are indexed to the Company’s stock, they are classified within stockholders’ equity in the accompanying
consolidated financial statements.
|
8.
|
2017 REGISTERED DIRECT OFFERING
|
On September 30, 2016, the Company filed a registration statement
with the SEC utilizing a “shelf” registration process, which was subsequently declared effective by the SEC on October
20, 2016 (such registration statement, the “
Shelf Registration Statement
”). Under the Shelf Registration Statement,
the Company may offer and sell any combination of its Common Stock, warrants, debt securities, subscription rights, and/or units
comprised of the foregoing to raise up to $50,000,000 in gross proceeds.
On February 20, 2017,
the Company entered into Securities Purchase Agreement (the “
2017
SPA
”)
with 6 accredited investors (collectively, the “
2017
Investors
”)
providing for the issuance and sale by the Company to the 2017 Investors of an aggregate of 10,166,664 units at a purchase
price of $0.60 per Unit in a registered offering (the “
2017 Financing
”).
The securities comprising the units sold in the 2017 Financing were issued under the Shelf Registration Statement, and
consisted of a share of Common Stock, and 0.55 of a Series F Warrant to purchase one share of Common Stock at an exercise
price of $0.75 per share at any time prior to the fifth anniversary of the issuance date of the Series F Warrant subject to
certain restrictions on exercise (the “
2017
Warrants
,”
and the shares issuable upon exercise of the 2017 Warrants, collectively, the “
2017
Warrant
Shares
”). Provisions in the 2017 SPA restrict the Company’s ability to
effect or enter into an agreement to effect any issuance by the Company or any of its subsidiaries of Common Stock or
securities convertible, exercisable or exchangeable for Common Stock (or a combination of units thereof) involving a Variable
Rate Transaction (as defined in the 2017 SPA) including, but not limited to, an equity line of credit or
“At-the-Market” financing facility until the three lead investors in the 2017 Financing collectively own less
than 20% of the Series F Warrants purchased by them pursuant to the 2017 SPA. The gross proceeds to Arch from the
2017 Financing, which closed on February 24, 2017, were approximately $6.1 million before deducting financing costs of
approximately $112,000.
The number of shares of the Company’s Common Stock into which
each of the Series F Warrants is exercisable and the exercise price therefore are subject to adjustment, as set forth in the Series
F Warrants, including adjustments for stock subdivisions or combinations (by any stock split, stock dividend, recapitalization,
reorganization, scheme, arrangement or otherwise). In addition, at anytime during the term of the Series F Warrants, the Company
may reduce the then-current exercise price to any amount and for any period of time deemed appropriate by the Board of the Company.
In addition, if the Company undergoes a change of control or is involved in a similar transaction, the holder may cause the Company
or any successor entity to purchase its Series F Warrant for an amount of cash equal to $0.18 for each share of Common Stock underlying
the Series F Warrant.
As of September 30, 2017, no Series F Warrants have been exercised.
As noted in Note 12, on September 28, 2016, the Company and
the Massachusetts Life Sciences Center (“MLSC”) entered into the Amendment. Pursuant to this Amendment, the term
“
Qualified Financing
” was defined to mean one or more financing transactions in which the Company
received, in a single transaction or series of transactions, cumulative net proceeds of not less than five million dollars
($5,000,000) at any time after October 3, 2016. On March 3, 2017 approximately $830,000 of the offering proceeds were used to
satisfy the Company’s outstanding indebtedness to MLSC under the MLSC Loan Agreement.
Common Stock
At February 24, 2017, the Closing Date of the 2017 Financing, the
Company issued 10,166,664 shares of Common Stock.
Derivative Liabilities
The Company accounted for the Series F Warrants relating to the
aforementioned 2017 Financing in accordance with ASC 815-10,
Derivatives and Hedging
. Since the Company may be required
to purchase its Series F Warrants for an amount of cash equal to $0.18 for each share of Common Stock the underlying Series F Warrants
are not classified within stockholders’ equity, they are recorded as liabilities at fair value. They are marked to market
each reporting period through the consolidated statement of operations.
On the Closing Date, the derivative liabilities were recorded
at fair value of $2,996,110. Given that the fair value of the derivative liabilities were less than the net proceeds of the
2017 Financing of $5,987,122, the remaining proceeds of $2,991,012 were allocated to the Common Stock and additional paid in
capital. During year ended September 30, 2017, $433,923 was recorded to Increase to fair value of derivative,
respectively.
Fair Value Measurements Using Significant Unobservable Inputs
(Level 3)
|
|
|
|
|
|
Warrant Derivative
Liability
|
|
Beginning balance at September 30, 2016
|
|
$
|
-
|
|
|
|
|
|
|
Issuances
|
|
|
2,996,110
|
|
|
|
|
|
|
Adjustments to estimated fair value
|
|
|
433,923
|
|
|
|
|
|
|
Ending balance at September 30, 2017
|
|
$
|
3,430,033
|
|
The derivative liabilities were valued as of February 24, 2017 and
September 30, 2017 using the Black Scholes Model with the following assumptions:
|
|
February 24,
2017
|
|
|
September 30,
2017
|
|
Closing price per share of common stock
|
|
$
|
0.68
|
|
|
$
|
0.60
|
|
Exercise price per share
|
|
$
|
0.75
|
|
|
$
|
0.75
|
|
Expected volatility
|
|
|
111.84
|
%
|
|
|
109.77
|
%
|
Risk-free interest rate
|
|
|
1.80
|
%
|
|
|
1.89
|
%
|
Dividend yield
|
|
|
—
|
|
|
|
—
|
|
Remaining expected term of underlying securities (years)
|
|
|
5.00
|
|
|
|
4.39
|
|
Beginning March 11, 2015 and through March 13, 2015, the Company
entered into a series of substantially similar subscription agreements (each a “Subscription Agreement”) with each
of Anson Investments Master Fund, Ltd., Equitec Specialists, LLC and Capital Ventures International (collectively, the “Note
Investors”) pursuant to which the Company issued unsecured 8% Convertible Notes (the “Notes”, and such transaction,
the “Notes Offering”) to the Note Investors in the aggregate principal amount of $750,000. On the closing of the Notes
Offering on March 13, 2015 (the “Closing Date”), each Note Investor was issued a Note in the principal amount of $250,000.
The Company did not engage any underwriter or placement agent in connection with the Notes Offering.
The Notes were originally due and payable on March 13, 2016 (the
“Stated Maturity Date”) and they were not prepayable or redeemable by the Company prior to the stated maturity date.
The Notes bore interest on the unpaid principal balance at a rate equal to eight percent (8.0%) (computed on the basis of the actual
number of days elapsed in a 360-day year) per annum until either (a) converted into shares of the Company’s common stock,
$0.001 par value per share (“Common Stock”) or (b) the outstanding principal and accrued interest on the Notes is paid
in full by the Company. Interest on the Notes became due and payable upon their conversion or the Stated Maturity Date and could
become due and payable upon the occurrence of an event of default under the Notes. The Notes contained customary events of default,
which include, among other things, (i) the Company’s failure to pay other indebtedness of $100,000 or more within the specified
cure period for such breach; (iii) the acceleration of the stated maturity of such indebtedness; (iii) the insolvency of the Company;
and (iv) the receipt of final, non-appealable judgments in the aggregate amount of $100,000 or more.
On September 8, 2015, we, along with the then current holders of
the Convertible Notes, entered into a series of substantially similar subordination agreements with the Massachusetts Life Sciences
Center (“
MLSC
” and such agreements, the “
Subordination Agreements
”), pursuant to which the
holders of the Convertible Notes agreed to subordinate their right to payment under the Convertible Notes to MLSC’s right
to receive payments under the MLSC Loan Agreement. Under the terms of the Subordination Agreements, the indebtedness accrued under
the Convertible Notes could not be repaid unless and until all indebtedness and fees owed to MLSC under the MLSC Loan Agreement
were repaid in full, but the right to convert the Convertible Notes into shares of Common Stock was expressly allowed.
At any time prior to the Stated Maturity Date, the holders of the
Notes had the right to convert some or all of such Notes into the number of shares of Common Stock determined by dividing (a) the
aggregate sum of the (i) principal amount of the Note to be converted, and (ii) amount of any accrued but unpaid interest with
respect to such portion of the Note to be converted; and (b) the conversion price then in effect (the shares of Common Stock issuable
upon such conversion, the “Conversion Shares”). The initial conversion price was $0.20 per share, and it could be (A)
reduced to any amount and for any period of time deemed appropriate by the Board of Directors of the Company, or (B) reduced or
increased proportionately as a result of stock splits, stock dividends, recapitalizations, reorganizations, and similar transactions.
A holder did not have the right to convert any portion of a Note, if after giving effect to such conversion, the holder, together
with its affiliates collectively, would beneficially own more than 4.99% or 9.99% (at the holder’s discretion) of the shares
of Common Stock outstanding immediately after giving effect to such conversion.
The issuance and sale of the Notes and Conversion Shares (collectively,
the “Securities”) was not, registered under the Securities Act of 1933, as amended (the “Securities Act”),
and the Securities may not be offered or sold in the United States absent registration under or exemption from the Securities Act
and any applicable state securities laws. The Securities were issued and sold in reliance upon an exemption from registration afforded
by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated under the Securities Act.
During the year ended September 30, 2016, $605,000 of Notes and
$39,900 of accrued interest were converted into 3,224,494 shares of the Company’s Common Stock. As of September 30, 2017
and September 30, 2016, principal amounts outstanding under the Notes amounted to $0.
Derivative Liabilities
The Company accounted for the conversion feature embedded within
the Notes in accordance with ASC 815-10,
Derivatives and Hedging
. The options to convert into Common Stock are not indexed
to the Company’s stock and are not classified within stockholders’ equity, the options to convert are recorded as liabilities
at fair value. They are marked to fair value each reporting period through the consolidated statement of operations.
On the Closing Date, the derivative liability was recorded at fair
value of $354,988 with the remaining proceeds of $395,012 allocated to the Notes. The allocation of funds to the derivative liability
resulted in a discount on the Notes, which was accreted to interest expense over the life of the loan. For the year ended September
30, 2016, $131,252, of the loan discount has been accreted to interest expense. As of September 30, 2016, the principal balance
of the outstanding Notes was $0.
As a result of the conversion of notes, we recorded a gain on
conversion of debt of $142,964 for the year ended September 30, 2016, and due to the change in the estimated fair value
of the derivative liability we recorded a decrease to fair value of derivative of $192,128 for the year ended September 30,
2016.
Fair Value Measurements Using Significant Unobservable Inputs
(Level 3)
|
|
|
|
|
|
Convertible
Debt
Derivative Liability
|
|
Beginning balance at September 30, 2015
|
|
$
|
335,092
|
|
|
|
|
|
|
Gain on conversion of debt
|
|
|
(142,964
|
)
|
|
|
|
|
|
Decrease to fair value of derivative
|
|
|
(192,128
|
)
|
|
|
|
|
|
Ending balance at September 30, 2016
|
|
$
|
-
|
|
The derivative liability was valued as of September 30, 2015, October
29, 2015 (weighted average conversion date) and December 31, 2015 using Monte Carlo Simulations with the following assumptions:
|
|
September 30,
|
|
|
|
2015
|
|
|
|
|
|
Stated interest rate
|
|
|
8.0
|
%
|
Exercise price per share
|
|
$
|
0.20
|
|
Expected volatility
|
|
|
80.0
|
%
|
Risk-free interest rate
|
|
|
0.07
|
%
|
Credit adjusted discount rate
|
|
|
22.0
|
%
|
Remaining expected term of underlying securities (years)
|
|
|
0.46
|
|
|
|
|
|
|
|
10.
|
STOCK-BASED COMPENSATION
|
2013 Stock Incentive Plan
On June 18, 2013, the Company established the 2013 Stock Incentive
Plan (the “2013 Plan”). Under the 2013 Plan, during the fiscal year ended September 30, 2016, a maximum number of 16,114,256
shares of the Company’s authorized and available common stock could be issued in the form of options, stock appreciation
rights, sales or bonuses of restricted stock, restricted stock units or dividend equivalent rights, and an award may consist of
one such security or benefit, or two or more of them in any combination or alternative. The 2013 Plan provides that on the first
business day of each fiscal year commencing with fiscal year 2014, the number of shares of our common stock reserved for issuance
under the 2013 Plan for all awards except for incentive stock option awards will be subject to increase by an amount equal to the
lesser of (A) 3,000,000 Shares, (B) four (4) percent of the number of shares outstanding on the last day of the immediately preceding
fiscal year of the Company, or (C) such lesser number of shares as determined by the Company’s Board of Directors (the “Board”).
The exercise price of each option shall be the fair value as determined in good faith by the Board at the time each option is granted.
On October 1, 2017, the aggregate number of authorized shares under the Plan was further increased by 3,000,000 shares to a total
of 19,114,256 shares.
As of September 30, 2017, a total of 13,524,212 options had been
issued to employees and directors and 5,282,500 options had been issued to consultants. The exercise price of each option has either
been equal to the closing price of a share of our common stock on the date of grant or has been determined to be in compliance
with Internal Revenue Section 409A.
Share-based awards
During the year ended September 30, 2017, the Company granted options
to employees and directors to purchase 2,495,000 shares of common stock under the 2013 Plan. In addition,
during the year ended September 30, 2017, the Company granted options to consultants to purchase 205,000 shares
of common stock under the 2013 Plan. The options have terms ranging from 1 to 10 years, are subject to vesting terms over periods
ranging up to 3 years and have exercise prices ranging from $0.60 to $0.65.
The Company recognizes compensation expense for stock option awards
on a straight-line basis over the applicable service period of the award. The service period is generally the vesting period, with
the exception of options granted subject to a consulting agreement, whereby the option vesting period and the service period are
defined pursuant to the terms of the consulting agreement. Share-based compensation expense for awards granted during the year
ended September 30, 2017 was based on the fair market value at period end or grant date fair value estimated using the Black-Scholes
Option Pricing Model. The following assumptions were used to calculate the fair value of share based compensation for the year
ended September 30, 2017; expected volatility, 72.26% - 119.44%, risk-free interest rate, 1.14% - 2.40%, expected forfeiture rate,
0.00%, expected dividend yield, 0.00%, expected term, 1 to 10 years.
Expected price volatility is the measure by which the Company’s
stock price is expected to fluctuate during the expected term of an option. The Company exited shell company status on June 26,
2013. In situations where a newly public entity has limited historical data on the price of its publicly traded shares and no other
traded financial instruments, authoritative guidance is provided on estimating this assumption by basing its expected volatility
on the historical, expected, or implied volatility of similar entities whose share option prices are publicly available. In making
the determination as to similarity, the guidance recommends the consideration of industry, stage of life cycle, size and financial
leverage of such other entities. The Company’s expected volatility is derived from the historical daily change in the market
price of its common stock since it exited shell company status, as well as the historical daily change in the market price for
the peer group as determined by the Company.
For so called “plain vanilla” options granted to employees,
the expected term of the options is based upon the simplified method as defined in ASC 718-10-S99 which averages an award’s
weighted-average vesting period and the contractual term for share options. The Company will continue to use the simplified method
until it has the historical data necessary to provide a reasonable estimate of expected life in accordance with ASC Topic 718.
The Company’s estimation of the expected term for stock options not subject to the simplified method is based upon the contractual
term of the option award. For the purposes of estimating the fair value of stock option awards, the risk-free interest rate used
in the Black-Scholes calculation is based on the prevailing U.S. Treasury yield. The Company has never paid any dividends on its
common stock and does not anticipate paying dividends on its common stock in the foreseeable future.
Stock-based compensation expense recognized in the Company’s
consolidated statements of operations is based on awards ultimately expected to vest, reduced for estimated forfeitures. Authoritative
guidance requires forfeitures to be estimated at the time of grant, and revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. Prior to the year ended September 30, 2015, the Company did not experience any forfeitures
of stock options. During the year ended September 30, 2017 and the year ended September 30, 2016, the Company experienced an insignificant
number of forfeitures of stock options. Since the Company has a limited history of stock option forfeitures it continues to estimate
the forfeiture rate of its outstanding stock options as zero, but will continually evaluate its historical data as a basis for
determining expected forfeitures
Common Stock Options
Stock compensation activity under the 2013 Plan for the year ended
September 30, 2017 follows:
|
|
Option
Shares
Outstanding
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Remaining
Contractual
Term (years)
|
|
|
Aggregate
Intrinsic
Value
|
|
Outstanding at September 30, 2016
|
|
|
12,379,210
|
|
|
$
|
0.33
|
|
|
|
6.4
|
|
|
$
|
4,341,816
|
|
Awarded
|
|
|
2,700,000
|
|
|
$
|
0.65
|
|
|
|
-
|
|
|
|
-
|
|
Exercised
|
|
|
(255,000
|
)
|
|
$
|
0.35
|
|
|
|
-
|
|
|
|
-
|
|
Forfeited/Cancelled
|
|
|
(190,000
|
)
|
|
$
|
0.39
|
|
|
|
-
|
|
|
|
-
|
|
Outstanding at September 30, 2017
|
|
|
14,634,210
|
|
|
$
|
0.39
|
|
|
|
4.72
|
|
|
$
|
6,178,263
|
|
Vested
|
|
|
11,776,130
|
|
|
$
|
0.36
|
|
|
|
5.09
|
|
|
$
|
5,321,198
|
|
Vested and expected to vest at September 30, 2017
|
|
|
14,634,210
|
|
|
$
|
0.39
|
|
|
|
4.72
|
|
|
$
|
6,178,263
|
|
As of September 30, 2017, 1,465,861 shares are available for future
grants under the 2013 Plan. Share-based compensation expense recorded in the Company’s Consolidated Statements of Operations
for the years ended September 30, 2017 and 2016 resulting from stock options awarded to the Company’s employees, directors
and consultants was approximately $1,343,000 and $938,000, respectively. Of this amount during the years ended September 30, 2017
and 2016, $374,000 and $270,000, respectively, was recorded to research and development expenses, and $969,000 and $668,000, respectively
was recorded in general and administrative expenses in the Company’s Consolidated Statements of Operations.
During the year ended September 30, 2017, 240,000 stock options
awarded under the 2013 Stock Incentive Plan were exercised on a cashless basis for an aggregate issuance of 106,666 shares of the
Company’s Common Stock. In addition, during the year ended September 30, 2017, 15,000 stock options awarded under the 2013
Stock Incentive Plan were exercised for cash for an aggregate issuance of 15,000 shares of the Company’s Common Stock.
As of September 30, 2017, there is approximately $809,000 of unrecognized
compensation expense related to unvested stock-based compensation arrangements granted under the 2013 Plan. That cost is expected
to be recognized over a weighted average period of 1.59 years.
Restricted Stock
On February 3, 2017, the Company awarded 1,750,000 shares of Restricted
Stock to members of the Board of Directors and management. The shares subject to this grant are awarded under the 2013 Plan and
100% shall fully vest on the second anniversary of the date of grant. In addition, in the event of a Change of Control (as such
term is defined in the 2013 Plan), 100% of the grants will immediately vest.
On August 9, 2016, we entered into a consulting agreement with Acorn
Management Partners, LLC (“Acorn”). In consideration of the services to be provided under and in accordance with the
terms of the consulting agreement, we issued (i) 225,000 shares of Common Stock under our 2013 Stock Incentive Plan at an agreed
upon value of $0.72 per share, which was the closing price of our common stock on August 9, 2016; and (ii) an option under our
2013 Stock Incentive Plan to purchase up to 375,000 shares of Common Stock at an exercise price of price of $0.72 per share, in
each case to John R. Exley, Acorn’s Chief Executive Officer and the party designated by Acorn to receive its shares and option.
The shares and option are subject to time-based vesting restrictions. Of the 225,000 shares of Common Stock granted to Mr. Exley,
75,000 vest 90 days from the date of the award, 75,000 vest 120 days from the date of the award and the remaining 75,000 shares
are scheduled to vest 150 days from the date of the award. Of the stock options to purchase up to 375,000 shares of Common Stock
awarded to Mr. Exley, 125,000 vest 90 days from the date of the award, 125,000 vest 120 days from the date of the award and the
remaining 125,000 shares are scheduled to vest 150 days from the date of the award. The issuance and sale of the shares of Common
Stock and option to Acorn has not been registered under the Securities Act, and such securities may not be offered or sold in the
United States absent registration under or exemption from the Securities Act and any applicable state securities laws. The securities
were issued and sold in reliance upon an exemption from registration afforded by Section 4(a)(2) of the Securities Act based on
the following facts: Acorn has represented that it is an accredited investor as defined in Regulation D promulgated under the Securities
Act, that it is acquiring the securities for investment only and not with a view towards, or for resale in connection with, a distribution
thereof in violation of applicable securities laws; that it understood that the securities would be issued as restricted securities
and as a result, it must bear the economic risk of its investment in the securities for an indefinite period of time.
Restricted stock activity under the 2013 Plan for the year ended
September 30, 2017 follows:
|
|
Restricted
Stock
Activity
|
|
Non Vested at September 30, 2016
|
|
|
225,000
|
|
Awarded
|
|
|
1,750,000
|
|
Vested
|
|
|
(225,000
|
)
|
Forfeited
|
|
|
-
|
|
Non Vested at September 30, 2017
|
|
|
1,750,000
|
|
The weighted average restricted stock award date fair value information
for the year ended September 30, 2017 follows:
|
|
Weighted
Average
Restricted
Stock Award
|
|
Non Vested at September 30, 2016
|
|
$
|
0.72
|
|
Awarded
|
|
|
0.65
|
|
Vested
|
|
|
0.72
|
|
Forfeited
|
|
|
-
|
|
Non Vested at September 30, 2017
|
|
$
|
0.65
|
|
Non-employee restricted shares subject to vesting are revalued
at each vesting date and at the end of the reporting period, with all changes in fair value recorded as stock-based
compensation expense. For the years ended September 30, 2017 and 2016 compensation expense recorded for the restricted stock
awards was approximately $372,000 and $0, respectively.
|
11.
|
Restricted Stock Awarded Outside the 2013 Stock Incentive
Plan
|
On May 3, 2016, the Company awarded 2,000,000 shares of Restricted
Stock to members of the Board of Directors and management in a private placement in reliance upon an exemption from registration
afforded by Section 4(a)(2) of the Securities Act. The shares subject to this grant are outside the 2013 Plan and 100% shall fully
vest on the second anniversary of the date of grant. In addition, in the event of a Change of Control (as such term is defined
in the 2013 Plan), 100% of the grants will immediately vest.
On August 6, 2015, we entered into separate consulting agreements
with two investor relations firms, Excelsior Global Advisors LLC (“
Excelsior
”) and Acorn. In consideration of
the services to be provided under and in accordance with the terms of each consulting agreement, we issued 300,000 shares of Common
Stock subject to time-based vesting restrictions to each of Excelsior and John R. Exley, Acorn’s Chief Executive Officer
and the party designated by Acorn to receive its shares, at an agreed upon value of $0.35 per share, which was the closing price
of our common stock on August 6, 2015. 150,000 of shares of common stock granted to each of Excelsior and Mr. Exley vested immediately
upon issuance, and the remaining 150,000 shares are scheduled to vest in 75,000, 50,000 and 25,000 share increments on September
4, 2015, October 2, 2015, and November 4, 2015, respectively. The issuance and sale of the shares of common stock to Excelsior
and Acorn has not been registered under the Securities Act, and such securities may not be offered or sold in the United States
absent registration under or exemption from the Securities Act and any applicable state securities laws. The securities were issued
and sold in reliance upon an exemption from registration afforded by Section 4(a)(2) of the Securities Act based on the following
facts: each of Excelsior and Acorn has represented that it is an accredited investor as defined in Regulation D promulgated under
the Securities Act, that it is acquiring the securities for investment only and not with a view towards, or for resale in connection
with, a distribution thereof in violation of applicable securities laws; that it understood that the securities would be issued
as restricted securities and as a result, it must bear the economic risk of its investment in the securities for an indefinite
period of time.
Restricted Stock activity for the years ended September 30, 2017
and 2016 is as follows:
|
|
2017
|
|
|
2016
|
|
Non Vested at beginning of year
|
|
|
2,000,000
|
|
|
|
150,000
|
|
Awarded
|
|
|
-
|
|
|
|
2,000,000
|
|
Vested
|
|
|
-
|
|
|
|
(150,000
|
)
|
Forfeited
|
|
|
-
|
|
|
|
-
|
|
Non Vested at end of year
|
|
|
2,000,000
|
|
|
|
2,000,000
|
|
The weighted average restricted stock award
date fair value information for the years ended September 30, 2017 and 2016 follows:
|
|
2017
|
|
|
2016
|
|
Non Vested at beginning of year
|
|
$
|
0.39
|
|
|
$
|
0.35
|
|
Awarded
|
|
|
-
|
|
|
|
0.39
|
|
Vested
|
|
|
-
|
|
|
|
0.35
|
|
Forfeited
|
|
|
-
|
|
|
|
-
|
|
Non Vested at end of year
|
|
$
|
0.39
|
|
|
$
|
0.39
|
|
For the years ended September 30, 2017 and 2016, compensation expense
recorded for the restricted stock awards was approximately $553,000 and $213,000, respectively.
On September 30, 2013, the Company entered into the Life Sciences
Accelerator Funding Agreement (the “
MLSC Loan Agreement
”) with the Massachusetts Life Sciences Center (“
MLSC
”),
pursuant to which MLSC provided an unsecured subordinated loan in the amount of $1,000,000 (the “
MLSC Loan
”).
The loan originally bore interest at a rate of 10% per annum, and was originally scheduled to become fully due and payable on the
earlier of (i) September 30, 2018, (ii) the occurrence of an event of default under the MLSC Loan Agreement, or (iii) the completion
of a sale of substantially all of our assets, a change-of-control transaction (a “
Qualified Sale
”) or one or
more financing transactions in which we receive from third parties other than our then existing shareholders net proceeds of $5,000,000
or more in a 12-month period (a “
Qualified Financing
”). The MLSC Loan Agreement includes warrants to purchase
145,985 shares of the Company’s Common Stock at an exercise price of $0.27 per share. None of the warrants, which expire
on September 30, 2023, have been exercised as of September 30, 2017.
Of the $1,000,000, the Company allocated $944,707 to the loan
and $55,293 to the warrants. The allocation of funds to the warrants resulted in a discount on the loan, which is accreted to
interest expense over the life of the loan. For the year ended September 30, 2017 and 2016, approximately $22,100 and $8,300,
respectively of the loan discount was accreted to interest expense. As of September 30, 2017, the balance of the
MLSC loan was $0. At September 30, 2016 the accreted balance of the MLSC Loan was $977,882.
On September 28, 2016, the Company and MLSC entered into that certain
Amendment Agreement to Arch Therapeutics, Inc. Accelerator Funding Agreement (the “
Amendment
”). Under the terms
of the Amendment, (i) interest on the MLSC Loan decreased from 10% per annum to 7% per annum beginning October 3, 2016; and (ii)
the MLSC Loan became due and payable on the earlier of October 3, 2017 (the “
Maturity Date
”), the occurrence
of a Corporate Event (which was defined as the occurrence of either a Qualified Sale or Qualified Financing), or the occurrence
of a Default (as defined in the promissory note issued in connection with the MLSC Loan Agreement). In addition, under the terms
of the Amendment, (a) beginning October 3, 2016, the Company began amortizing the principal and accrued interest under the MLSC
Loan by making the first of 13 monthly payments of approximately $106,022, with the last payment scheduled to occur on the Maturity
Date; and (b) the term “
Qualified Financing
” was defined to mean one or more financing transactions in which
we receive, in a single transaction or series of transactions, cumulative net proceeds of not less than five million dollars ($5,000,000)
at any time after October 3, 2016. As a result of the Amendment, the Company expected to reduce interest expenses that would otherwise
be incurred under the MLSC Loan Agreement by approximately $232,000 due to the effect of the amortization payments and the lower
7% per annum interest rate. On February 24, 2017, the Company completed a registered direct offering with gross proceeds of approximately
$6.1 million, which under the Amendment, qualified as a Corporate Event. On March 3, 2017 approximately $830,000 of the offering
proceeds were used to satisfy the outstanding indebtedness to the MLSC under the MLSC Loan Agreement. As a result of the Amendment
and the acceleration of the Company’s obligation to repay the MLSC Loan as a result of the offering, the Company reduced
interest expenses that would otherwise be incurred under the MLSC Loan Agreement by approximately $250,000.
|
13.
|
COMMITMENTS AND CONTINGENCIES
|
In the ordinary course of business, the Company enters into various
agreements containing standard indemnification provisions. The Company's indemnification obligations under such provisions are
typically in effect from the date of execution of the applicable agreement through the end of the applicable statute of limitations.
The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain. As of September
30, 2017 and 2016, no amounts have been accrued related to such indemnification provisions.
From time to time, the Company may be exposed to litigation in connection
with its operations. The Company’s policy is to assess the likelihood of any adverse judgments or outcomes related to legal
matters, as well as ranges of probable losses.
MIT Licensing Agreement
In December, 2007, the Company entered into a license agreement
with MIT pursuant to which the Company acquired an exclusive world-wide license to develop and commercialize technology related
to self-assembling peptide compositions, and methods of making and using such compositions in medical and non-medical applications,
including claims that cover the Company’s proposed products and methods of use thereof. The license also provides non-exclusive
rights to additional intellectual property in the fields that cover the Company’s proposed products and methods of use thereof,
in order to provide freedom to operate. The license provides the Company a right to sublicense the exclusively licensed intellectual
property. The Company has not sublicensed the exclusively licensed intellectual property to any party for any field.
In exchange for the licenses granted in the agreement, the Company
has paid MIT license maintenance fees and patent prosecution costs. The Company paid license maintenance fees of $50,000 to MIT
in the fiscal years ended September 30, 2017 and September 30, 2016. For the years ended September 30, 2017 and 2016, the annual
MIT license maintenance fees of $50,000 are included in accrued expenses and other liabilities on the Consolidated Balance Sheets.
The license maintenance fees and patent prosecution costs cover the contract year beginning January 1 thru December 31. Annual
license maintenance obligations extend through the life of the patents. In addition, MIT is entitled to royalties on applicable
future product sales, if any. The annual payments may be applied towards royalties payable to MIT for that year for product sales.
The Company is obligated to indemnify MIT and related
parties from losses arising from claims relating to the exercise of any rights granted to the Company under the license, with certain
exceptions. The maximum potential amount of future payments the Company could be required to make under this provision is unlimited.
The Company considers there to be a low performance risk as of September 30, 2017.
The agreement expires upon the expiration or abandonment
of all patents that are issued and licensed to the Company by MIT under such agreement. The Company expects that patents will be
issued from presently pending U.S. and foreign patent applications. Any such patent will have a term of 20 years from the filing
date of the underlying application. MIT may terminate the agreement immediately, if the Company ceases to carry on its business,
if any nonpayment by the Company is not cured or the Company commits a material breach that is not cured. The Company may terminate
the agreement for any reason upon six months’ notice to MIT.
Leases
We do not own any real property. In October 2013, we entered
into a one and one-half year operating sublease agreement pursuant to which we leased the office space of our relocated headquarters
in Wellesley, Massachusetts for a base annual rent equal to $5,031 per month. In April 2015, we moved our corporate offices to
a property in Framingham, Massachusetts. We entered into a month-to-month operating lease agreement, pursuant to which we are obligated
to pay monthly rent of $2,000, with a minimum six month commitment. During July 2017,we entered into a three year operating lease
commencing October 1, 2017 and ending on September 30, 2020 at our current location. Pursuant to which we are obliged to pay annual
rent of $38,400 during the first year, $39,600 during the second year and $42,000 during the third year. We are no longer party
to the October 2013 lease, and we believe our present offices are suitable for our current and planned near-term operations.
The following table reflects the Company’s annual lease commitments:
Year Ending
September 30,
|
|
|
|
2018
|
|
$
|
38,400
|
|
2019
|
|
|
39,600
|
|
2020
|
|
|
42,000
|
|
|
|
$
|
120,000
|
|
During the period commencing October 1, 2017 through November 14,
2017, additional Series D warrants have been exercised for an aggregate issuance of 227,273 shares of the Company’s Common
Stock at an exercise price of $0.25 per share, resulting in gross proceeds of $56,818. In addition, Series E warrants have been
exercised for an aggregate issuance of 15,000 shares of the Company’s Common Stock at an exercise price of $0.438 per share,
resulting in gross proceeds of $6,570.