U.S. SECURITIES AND EXCHANGE COMMISSION
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined
in Rule 405 of the Securities Act. [_]Yes [X] No
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 [X] No
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.
[X] Yes [_]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). [X] Yes [_]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, or a smaller reporting company. See the definitions of “large accelerated
filer,” “accelerated filer” and “small reporting company” in Rule 12b-2 of the Exchange Act. Large
accelerated filer
[_]
Accelerated filer [_] Non-accelerated filer [_] (Do not check if a smaller reporting company)
Smaller Reporting Company [X]
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Act).
The aggregate market value of the voting and non-voting common equity
held by non-affiliates of the registrant, based upon the closing sale price of the registrant’s common stock as reported
on the OTCQB on June 30, 2015 was approximately $5,600,000. Shares of common stock held by each officer and director and by each
person who owns 10% or more of the outstanding common stock have been excluded in that such persons may be deemed to be affiliates.
This determination of affiliate status is not necessarily conclusive.
The number of outstanding shares of the registrant’s common
stock on March 15, 2016, was 40,885,411.
PART
I
Item 1. Business
Overview of the Business
Capstone Therapeutics Corp. (the “Company” or “we”)
is a biotechnology company committed to developing a pipeline of novel peptides and other molecules aimed at helping patients
with under-served medical conditions. Previously, we were focused on the development and commercialization of two product platforms:
AZX100 and Chrysalin (TP508). Since March 2012, we no longer have any interest in or rights to Chrysalin. In 2012 we wound down
internal research operations, ceased clinical development of AZX100 in dermal scarring, formerly our principal drug candidate,
and moved to a more virtual operating model. In 2014, we terminated the License Agreement for AZX100 intellectual property and
returned all interest in and rights to the AZX100 intellectual property to the Licensor (AzTE).
On August 3, 2012, we entered into a joint venture, LipimetiX Development,
LLC (now LipimetiX Development, Inc.), (the “JV”) to develop Apo E mimetic peptide molecule AEM-28 and its analogs.
The JV has a development plan to pursue regulatory approval of AEM-28, or an analog, as treatment for Homozygous Familial Hypercholesterolemia
(“HoFH”) (granted Orphan Drug Designation by FDA in 2012), Acute Hypertriglyceridemic Pancreatitis (“AP”),
diabetic dyslipidemia and other hyperlipidemic indications. The initial development plan extended through Phase 1a and 1b/2a clinical
trials and was completed in the fourth quarter of 2014. The clinical trials had a safety primary endpoint and an efficacy endpoint
targeting reduction of cholesterol and triglycerides.
In early 2014, the JV received allowance from regulatory authorities
in Australia permitting the JV to proceed with the planned clinical trials. The Phase 1a clinical trial commenced in Australia
in April 2014 and the Phase 1b/2a clinical trial commenced in Australia in June 2014. The clinical trials for AEM-28 are randomized,
double-blinded, placebo-controlled studies to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of six
escalating single doses (Phase 1a in healthy patients with elevated cholesterol) and multiple ascending doses of the three highest
doses from Phase 1a (Phase 1b/2a in patients with hypercholesterolemia and healthy subjects with elevated cholesterol and high
Body Mass Index). The Phase 1a clinical trial consisted of 36 patients and the Phase 1b/2a consisted of 15 patients. Both clinical
trials were completed in 2014 and the Medical Safety Committee, reviewing all safety-related aspects of the clinical trials, observed
a generally acceptable safety profile. As first-in-man studies, the primary endpoint was safety; yet efficacy measurements analyzing
pharmacodynamics yielded statistical significance in the pooled dataset favoring AEM-28 versus placebo in multiple lipid biomarker
endpoints.
Concurrent with the development activities with AEM-28, the JV has
performed limited pre-clinical studies that have identified an analog of AEM-28, referred to as AEM-28-14, and a new formulation,
that has the potential of greater efficacy, higher human dose toleration and an extended composition of matter patent life (application
filed with the U.S. Patent and Trademark Office in 2015).
The JV and Company intend to explore fundraising, partnering or
licensing, to obtain additional funding to continue development activities of AEM-28 and its analogs.
The JV and the Company do not have sufficient funding at this time
to continue additional material development activities of AEM-28 and its analogs. The JV may conduct future clinical trials in
Australia, the USA, and other regulatory jurisdictions if regulatory approvals, additional funding, and other conditions permit.
The JV may also fund research or studies to investigate AEM-28-14 for treatment of acute coronary syndrome and other indications.
The Company, funding permitting, intends to continue limiting its
internal research operations to a virtual operating model while monitoring and participating in the management of LipimetiX Development,
Inc’s AEM-28 and analogs development activities. We intend to maintain the required level of corporate governance and reporting
that would be required to comply with Securities and Exchange Commission (“SEC”) rules and regulations, except that
effective with the filing of this Annual Report on Form 10-K without the opinion of an Independent Public Accountant, we will
not be in compliance with SEC Rules and Regulations.
Description of Our Peptide Drug Candidates.
Chimeric Apo E Mimetic Peptide Molecule – AEM-28 and its
analogs
Apolipoprotein E is a 299 amino acid protein that plays an important
role in lipoprotein metabolism. AEM-28 is a 28 amino acid mimetic of Apo E and AEM-28 and its analogs, including AEM-28-14 is
a 28 amino acid mimetic of Apo E (with an aminohexanoic acid group and a phospholipid), and both contain a domain that anchors
into a lipoprotein surface while also providing the Apo E receptor binding domain, which allows clearance through the heparan
sulfate proteoglycan (HSPG) receptors (Syndecan-1) in the liver. AEM-28 and its analogs, including AEM-28-14, as Apo E mimetics,
have the potential to restore the ability of these atherogenic lipoproteins to be cleared from the plasma, completing the reverse
cholesterol transport pathway, and thereby reducing cardiovascular risk. This is an important mechanism of action for AEM-28 and
its analogs, including AEM-28-14. For patients that lack LDL receptors (Homozygous Familial Hypercholesterolemia-HoFH), have acute
pancreatitis (“AP”), or have hypercholesterolemia, AEM-28 and its analogs may provide a therapeutic solution. Our
joint venture has an Exclusive License Agreement with the University of Alabama at Birmingham Research Foundation for AEM-28 and
certain of its analogs.
Company History
Prior to November 2003, we developed, manufactured and marketed
proprietary, technologically advanced orthopedic products designed to promote the healing of musculoskeletal bone and tissue,
with particular emphasis on fracture healing and spine repair. Our product lines, which included bone growth stimulation and fracture
fixation devices, are referred to as our “Bone Device Business.” In November 2003, we sold our Bone Device Business.
In August 2004, we purchased substantially all of the assets and
intellectual property of Chrysalis Biotechnology, Inc. (“CBI”), including its exclusive worldwide license for Chrysalin
for all medical indications. Subsequently, our efforts were focused on research and development of Chrysalin with the goal of
commercializing our products in fresh fracture healing. (In March 2012, we returned all rights to the Chrysalin intellectual property
and no longer have any interest in, or rights to Chrysalin.)
In February 2006, we purchased certain assets and assumed certain
liabilities of AzERx, Inc. Under the terms of the transaction, we acquired an exclusive license for the core intellectual property
relating to AZX100, an anti-fibrotic peptide. In 2014, we terminated the License Agreement with AzTE (Licensor) for the core intellectual
property relating to AZX100 and returned all interest in and rights to the AZX100 intellectual property to the Licensor.
On August 3, 2012, we entered into a joint venture, LipimetiX Development,
LLC (now LipimetiX Development, Inc.), (see Note 9 in Notes to Financial Statements included in this Annual Report on Form 10-K
for more information) to develop Apo E mimetic peptide molecule AEM-28 and analogs.
Our development activities represent a single operating segment
as they shared the same product development path and utilized the same Company resources. As a result, we determined that it is
appropriate to reflect our operations as one reportable segment.
OrthoLogic Corp. commenced doing business under the trade name of
Capstone Therapeutics on October 1, 2008, and we formally changed our name from OrthoLogic Corp. to Capstone Therapeutics Corp.
on May 21, 2010.
In this Annual Report, references to “we”, “our”,
the “Company”, “Capstone Therapeutics”, “Capstone”, and “OrthoLogic” refer to
Capstone Therapeutics Corp. References to our joint venture, or the “JV”, refer to LipimetiX Development, Inc. (previously
LipimetiX Development, LLC).
Competition
The biopharmaceutical industry is characterized by intense competition
and confidentiality. Cholesterol reduction therapy is one of the largest drug markets served by numerous approved medications
and with numerous potential therapies in various stages of clinical development. Well known cardiovascular drug classes include
the statins and PCSK9s (currently in regulatory approval process). Our drug candidates, if approved, would not compete directly
for the same patient population as statins and PCSK9s. In the orphan indication of HoFH, two drugs received FDA approval in 2013
and are currently being marketed: Juxtapid from Aegerion and Kynamro from Sanofi/Genzyme. In the AP indication, the standard of
care drugs for reducing triglycerides include fish oil and fibrates, both of which usually take weeks to show an effect. We are
currently unaware of any other drugs approved or in development for reducing triglycerides in AP. We may not be aware of the other
biotechnology, pharmaceutical companies or public institutions that are developing pharmaceuticals or devices that may compete
with our potential products. We also may not be aware of all the other competing products our known competitors are pursuing.
In addition, these biotechnology companies and public institutions compete with us in recruiting for research personnel and subjects,
which may affect our ability to complete our research studies. For additional discussion regarding the risks associated with our
competition, see the risk factor
“If our JV’s product candidates do not gain market acceptance or our competitors
develop and market products that are more effective than our JV’s product candidates, our commercial opportunities will
be reduced or eliminated”
in the “Risk Factors” section in this Annual Report on Form 10K.
Marketing and Sales
AEM-28 and its analogs are not currently available for sale and
we do not expect them to be available for sale for some time into the future, if ever. Thus, neither we nor our JV currently have
any marketing or sales staff. External consultants and members of our staff provide some technical marketing support relating
to the development of, and market need for, new potential products and additional therapeutic applications of products already
under research.
Research and Development
At December 31, 2015, we had two
administrative employees and utilized consultants to perform various administrative, regulatory or research tasks. We have entered
into consulting agreements with former employees in an effort to retain their availability to render services if and when needed.
Our research and development for 2015 and 2014 consisted primarily
of work with or through our joint venture.
Through our joint venture, LipimetiX Development, Inc. (“JV”),
we incurred expenses of $1.0 million and $2.4 million relating to AEM-28 and analogs research efforts in 2015 and 2014, respectively.
The JV has a development plan to pursue regulatory approval of AEM-28 or an analog (AEM-28-14), as treatment for Homozygous Familial
Hypercholesterolemia (granted Orphan Drug Designation by FDA in 2012), AP and other hyperlipidemic indications. The initial development
plan extended through Phase 1a and 1b/2a clinical trials and was completed in the fourth quarter of 2014. The clinical trials
had a safety primary endpoint and an efficacy endpoint targeting cholesterol and lipid reduction.
The JV received allowance from regulatory authorities in Australia
permitting the JV to proceed with the planned clinical trials. The Phase 1a clinical trial commenced in Australia in April 2014
and the Phase 1b/2a clinical trial commenced in Australia in June 2014. The clinical trials for AEM-28 are randomized, double-blinded,
placebo-controlled studies to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of six escalating single
doses (Phase 1a in healthy patients with elevated cholesterol) and multiple ascending doses of the three highest doses from Phase
1a (Phase 1b/2a in patients with hypercholesterolemia and healthy subjects with elevated cholesterol and high Body Mass Index).
The Phase 1a clinical trial consisted of 36 patients and the Phase 1b/2a consisted of 15 patients. Both clinical trials were completed
in 2014 and the Medical Safety Committee, reviewing all safety-related aspects of the clinical trials, observed a generally acceptable
safety profile. As first-in-man studies, the primary endpoint was safety; yet efficacy measurements analyzing pharmacodynamics
yielded statistical significance in the pooled dataset favoring AEM-28 versus placebo in multiple lipid biomarker endpoints.
Concurrently with the development activities with AEM-28, the JV
has performed limited pre-clinical studies that have identified an analog of AEM-28, referred to as AEM-28-14, and a new formulation,
that has the potential of greater efficacy, higher human dose toleration and an extended composition of matter patent life (application
filed in 2015). AEM-28-14 has become the JV’s lead drug candidate for commercial development.
Manufacturing
Currently, third parties certified under Good Manufacturing Practices
manufacture AEM-28 and its analogs for us in limited amounts for our clinical and pre-clinical studies. We use a primary manufacturer
for the peptides used in our human clinical trials, but secondary manufacturers are available as needed. AEM-28 and its analogs
chemistry, manufacturing and control plan is currently based on an infusion formulation.
Patents, Licenses and Proprietary Rights
The JV has an Exclusive License Agreement (the “Agreement)
with the University of Alabama at Birmingham Research Foundation (“UABRF”) covering AEM-28 and certain analogs (included
as Exhibit 10.7 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2012, filed with
the Securities and Exchange Commission on August 10, 2012, and as amended effective December 15, 2014, included as Exhibit 10.1
to the Company’s Current report on Form 8-K, filed with the Securities and Exchange Commission on January 30, 2015). The
Agreement calls for payment of patent filing, maintenance and other related patent fees, as well as a royalty of 3% on Net Sales
of Licensed Products during the Term of the Agreement. The Agreement terminates upon the expiration of all Valid Patent Claims
within the Licensed Patents, currently estimated to be 2035. The Agreement, as amended, also calls for annual maintenance payments
of $25,000, various milestone payments of $50,000 to $500,000 and minimum royalty payment of $500,000 to $1,000,000 per year commencing
on January 1 of the first calendar year following the year in which the First Commercial Sale occurs. UABRF will also receive
5% of Non Royalty Income received.
Insurance
Our business entails the risk of product liability claims. We maintain
a product liability and general liability insurance policy and an umbrella excess liability policy. There can be no assurance
that liability claims will not exceed the coverage limit of such policies or that such insurance will continue to be available
on commercially reasonable terms or at all. Consequently, product liability claims or claims arising from our clinical trials
could have a material adverse effect on our business, financial condition and results of operations. We have not experienced any
material liability claims to date resulting from our clinical trials.
Employees
As of December 31, 2015, we had two full time administrative employees
in our operations and utilize consultants to perform a variety of administrative, regulatory or research tasks. We have entered
into consulting agreements with various former key employees, but there is no assurance that these persons will be available in
the future to the extent their services may be needed. As a research and development business, we believe that the success of
our business will depend in part on our ability to identify, attract and retain qualified research personnel, both as employees
and as consultants. We face competition from private companies and public institutions for qualified research personnel. None
of our employees are represented by a union and we consider our relationship with our employees to be good.
Additional Information about Capstone Therapeutics
We were incorporated as a Delaware corporation in July 1987 as IatroMed,
Inc. We changed our name to OrthoLogic Corp. in July 1991. Effective October 1, 2008, OrthoLogic Corp. commenced doing business
under the trade name of Capstone Therapeutics and we formally changed our name to Capstone Therapeutics Corp. on May 21, 2010.
Our executive offices are located at 1275 West Washington Street, Suite 104, Tempe, Arizona 85281, and our telephone number is
(602) 286-5520.
Our website address is www.capstonethx.com. Our annual reports on
Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, as well as any amendments to those reports, are available
free of charge through our website as soon as reasonably practical after we file or furnish them to the U.S. Securities and Exchange
Commission. Once at our website, go to the “Investors” section to locate these filings. Copies of the materials we
file with the Securities and Exchange Commission can also be obtained free of charge from the Securities and Exchange Commission’s
website at www.sec.gov, or by contacting the Securities and Exchange Commission’s Public Reference Room at 100 F Street
N.E., Washington, D.C. 20549 or by calling 1-800-SEC-0330.
We adopted a code of ethics that applies to all of our employees
and has particular sections that apply only to our principal executive officer and senior financial officers. We posted the text
of our code of ethics on our website in the “Investors” section of our website under “Corporate Governance”,
“Code of Ethics.” In addition, we will promptly disclose on our website (1) the nature of any amendment to our code
of ethics that applies to our principal executive officer and senior financial officers, and (2) the nature of any waiver, including
an implicit waiver, from a provision of our code of ethics that is granted to one of these specified officers, the name of such
officer who is granted the waiver and the date of the waiver.
Item 1A. Risk Factors
Safe Harbor
We may from time to time make written or oral forward-looking statements,
including statements contained in our filings with the Securities and Exchange Commission and our reports to stockholders. The
safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 protects companies
from liability for their forward looking statements if they comply with the requirements of that Act. This Annual Report on Form
10-K contains forward-looking statements made pursuant to that safe harbor. These forward-looking statements relate to future
events or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause
our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels
of activity, performance or achievements expressed or implied by these forward-looking statements. In some cases, you can identify
forward-looking statements by the use of words such as “may,” “could,” “expect,” “intend,”
“plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,”
“potential,” “continue,” or the negative of these terms or other comparable terminology. You should not
place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors
which are, in some cases, beyond our control and which could materially affect actual results, levels of activity, performance
or achievements. Factors that may cause actual results to differ materially from current expectations, which we describe in more
detail in this section titled “Risks,” include, but are not limited to:
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Effect of non-compliance with SEC Rules and Regulations requiring
this Annual Report on Form 10-K to include an opinion of an Independent Public Accountant.
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Failure
to obtain additional funds to continue operations;
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the
impact of the terms or conditions of agreements associated with funds obtained to fund
operations;
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failure
to obtain additional funds required to complete clinical trials and supporting research
and production efforts necessary to obtain FDA or comparable foreign agencies approval
for product candidates or secure development agreements with pharmaceutical manufacturers;
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the
impact of using a virtual operating model;
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unfavorable
results of product candidate development efforts;
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unfavorable
results of pre-clinical or clinical testing;
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delays
in obtaining, or failure to obtain FDA or comparable foreign agencies approvals;
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increased
regulation by the FDA or comparable foreign agencies;
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the
introduction of competitive products;
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impairment
of license, patent or other proprietary rights;
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the
impact of present and future joint venture, collaborative or partnering agreements or
the lack thereof; and
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failure
to successfully implement our drug development strategy for AEM-28 and its analogs.
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If one or more of these or other risks or uncertainties materialize,
or if our underlying assumptions prove to be incorrect, actual results may vary significantly from what we projected. Any forward-looking
statement you read in this Annual Report on Form 10-K reflects our current views with respect to future events and is subject
to these and other risks, uncertainties and assumptions relating to our operations, results of operations, business strategy and
liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update
the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information
becomes available in the future.
Risks Related to Our Business and Industry
This Annual Report on Form 10-K has been filed with the SEC
without an opinion of an idependent public accountant, as required by current SEC rules and regulations, and as required to be
listed on the OTCQB Markets.
Our current level of funds available for operation has led to additional
cost cutting, which included the decision to not engage an independent public accountant to audit and express an opinion on our
December 31, 2015 financial statements included in this Annual Report on Form 10-K, as required by current SEC rules and regulations,
and as required to be listed on the OTCQB Market. We cannot currently predict the response to this action by the SEC or the OTCQB
Market, nor the effects of their action on the continued financial viability of the Company or the trading of its common stock.
The decision to not engage an independent public accountant to audit and express an opinion on our December 31, 2015 financial
statements could have a material adverse effect on the Company and its Stockholders.
The audit opinion from our independent accounting firm, Moss
Adams, LLC, on our December 31, 2014 financial statements, included in our Annual Report on Form 10-K, filed with the SEC on March
16, 2015, includes an explanatory paragraph as to an uncertainty with respect to the our ability to continue as a going concern
.
We had accumulated deficit balance of $189 million as of December
31, 2015. Our net loss for the year ended December 31, 2015 was $2.8 million. We currently have no pharmaceutical products being
sold or ready for sale and do not expect to be able to introduce any pharmaceutical products or generate any revenue for at least
several years. We expect to incur losses for at least the next several years. Our cash reserves are the primary source of our
working capital. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern.
We are a biopharmaceutical company with no revenue generating
operations and high investment costs. Therefore, we will require additional funding to realize revenue from any of our JV’s
product candidates, and we may never realize any revenue if our JV’s product candidates cannot be commercialized
.
Our current level of funds is not sufficient to support continued
research to develop our JV’s product candidates, and will not be sufficient to fund all the research expenses necessary
to achieve commercialization of any of our JV’s product candidates. We will require substantial additional capital, and/or
a development partner, to complete the clinical trials and supporting research and production efforts necessary to obtain FDA
or comparable foreign agencies’ approval, if any, for our JV’s product candidates. We may not receive any revenue
from our JV’s product candidates until we receive regulatory approval and begin commercialization of our JV’s product
candidates. We cannot predict whether, or when, that might occur.
Our JV partners have significant rights as minority-interest
stockholders of our JV. Although we own 60% of the outstanding shares of our JV’s common stock, the minority stockholders
of the JV have the right to appoint a majority of the JV’s board of directors.
Pursuant to a Stockholders Agreement among all the stockholders
of our JV, we have agreed that the board of directors of the JV will be composed of three individuals designated by the minority
stockholders and two individuals designated by us. Consequently, our JV partners’ designees, and not our designees, control
the JV’s board of directors. If the JV fails to operate substantially in accordance with its annual budget, including the
milestones specified therein, or fails to comply with its obligations under the Stockholders Agreement, we will thereafter have
the right to appoint a majority of the members of the JV’s board of directors.
Under the Stockholders Agreement, the consent of stockholders acting
by a majority in interest is required for a broad range of actions, including annual budgets and operational milestones. Because
we are the majority stockholder, these consent rights protect our interests in the JV. However, there is a risk that these consent
rights may be insufficient to protect our interests or may result in impasses with respect to the JV’s management and operation,
the resolution of which might result in actions, agreements or consequences that we might view as suboptimal. There is no assurance
that the minority stockholders of the JV will share the same economic, business or legal interests or goals that we have for the
JV's business.
Our business is subject to stringent regulation, and if we
do not obtain regulatory approval for our JV's product candidates, we will not be able to generate revenue.
Our JV’s research, development, pre-clinical and clinical
trial activities and the manufacture and marketing of any products that it may successfully develop are subject to an extensive
regulatory approval process by the FDA and other regulatory agencies in the United States and abroad. The process of obtaining
required regulatory approvals for pharmaceutical products is lengthy, expensive and uncertain, and any such regulatory approvals
may entail limitations on the indicated usage of a product, which may reduce the product’s market potential.
None of our JV's product candidates have been approved for sale.
In order to obtain FDA or comparable foreign agency approval to commercialize any product candidate, a New Drug Application (NDA)
(or comparable foreign agency form) must be submitted demonstrating, among other things, that the product candidate is safe and
effective for use in humans for each target indication. Our or our JV’s regulatory submissions may be delayed, or we or
our JV may cancel plans to make submissions for product candidates for many reasons, including unfavorable results from or delays
in preclinical or clinical trials and lack of sufficient available funding.
If we experience delays in our JV’s clinical trials, we will
incur additional costs and our opportunities to monetize product candidates will be deferred. Delays could occur for many reasons,
including the following:
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the FDA or
other health regulatory authorities, or institutional review boards, do not approve a
clinical study protocol or place a clinical study on hold;
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suitable patients
do not enroll in a clinical study in sufficient numbers or at the expected rate, or data
is adversely affected by trial conduct or patient drop out;
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patients experience
serious adverse events, including adverse side effects of our JV’s product candidates;
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patients in
the placebo or untreated control group exhibit greater than expected improvements or
fewer than expected adverse events;
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third-party
clinical investigators do not perform the clinical studies on the anticipated schedule
or consistent with the clinical study protocol and good clinical practices, or other
third-party organizations do not perform data collection and analysis in a timely or
accurate manner;
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service providers,
collaborators or co-sponsors do not adequately perform their obligations in relation
to the clinical study or cause the study to be delayed or terminated;
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we experience
difficulties in obtaining sufficient quantities of the particular product candidate or
any other components needed for pre-clinical testing or clinical trials;
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regulatory
inspections of manufacturing facilities, which may, among other things, require us or
a co-sponsor to undertake corrective action or suspend the clinical studies;
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the interim
results of the clinical study are inconclusive or negative;
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the clinical
study, although approved and completed, generates data that is not considered by the
FDA or others to be sufficient to demonstrate safety and efficacy;
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changes in
governmental regulations or administrative actions affect the conduct of the clinical
trial or the interpretation of its result;
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there is a
change in the focus of our JV’s development efforts or a re-evaluation of its clinical
development strategy; and
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we lack of
sufficient funds to pay for development costs.
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Consequently, we cannot assure that we or our JV will make submissions
to the FDA or comparable foreign agencies in the timeframe that we have planned, or at all, or that our and our JV’s submissions
will be approved by the FDA or comparable foreign agencies. Even if regulatory clearance is obtained, post-market evaluation of
our JV’s future products, if required, could result in restrictions on a product’s marketing or withdrawal of a product
from the market as well as possible civil and criminal sanctions.
If our JV’s product candidates do not gain market acceptance
or our competitors develop and market products that are more effective than our JV’s product candidates, our commercial
opportunities will be reduced or eliminated.
Even if our JV brings one or more products to market, there is no
assurance that our JV will be able to successfully manufacture or market the products or that potential customers will buy them.
Market acceptance will depend on our ability to demonstrate to physicians and patients the benefits of the future products in
terms of safety, efficacy, and convenience, ease of administration and cost effectiveness, as well as on our JV’s ability
to continue to develop product candidates to respond to competitive and technological changes. In addition, we believe that market
acceptance depends on the effectiveness of our marketing strategy, the pricing of our JV’s future products and the reimbursement
policies of government and third-party payors. Physicians may not prescribe our JV’s future products, and patients may determine,
for any reason, that our JV’s product is not useful to them. Insurance companies and other third party payors may determine
not to reimburse for the cost of the product.
Competition in the pharmaceutical and biotechnology industries is
intense and is expected to increase. Several biotechnology and pharmaceutical companies, as well as academic laboratories, universities
and other research institutions, are involved in research and/or product development for indications targeted for use by AEM-28
and its analogs. Most of our competitors have significantly greater research and development capabilities, experience in obtaining
regulatory approvals and manufacturing, marketing, financial and managerial resources than we have.
Our competitors may succeed in developing products that are more
effective than the ones we have under development or that render our proposed products or technologies noncompetitive or obsolete.
In addition, certain of our competitors may achieve product commercialization before we do. If any of our competitors develops
a product that is more effective than one that our JV is developing or plans to develop, or is able to obtain FDA or comparable
foreign agencies’ approval for commercialization before we do, we may not be able to achieve significant market acceptance
for certain of our JV’s products, which would have a material adverse effect on our JV’s business.
For a summary of the competitive conditions relating to indications
which we are currently considering for AEM-28 and its analogs, see “Competition” in this prospectus.
If we cannot protect our joint venture’s AEM-28, AEM-28-14
and other patents, or our JV’s intellectual property generally, our JV’s ability to develop and commercialize its
future products will be severely limited.
Our success will depend in part on our joint venture’s ability
to maintain and enforce patent protection for AEM-28 and its analogs and each resulting product. Without patent protection, other
companies could offer substantially identical products for sale without incurring the sizable discovery, development and licensing
costs that our joint venture has incurred. Our JV’s ability to recover these expenditures and realize profits upon the sale
of products would then be diminished.
AEM-28 is patented and patent applications for the AEM-28 analogs
have be filed. There have been no successful challenges to the patents. However, if there were to be a challenge to these patents
or any of the patents for product candidates, a court may determine that the patents are invalid or unenforceable. Even if the
validity or enforceability of a patent is upheld by a court, a court may not prevent alleged infringement on the grounds that
such activity is not covered by the patent claims. Any litigation to enforce our JV’s rights to use its or its licensors’
patents will be costly, time consuming and may distract management from other important tasks.
As is commonplace in the biotechnology and pharmaceutical industries,
we employ, or engage as consultants, individuals who were previously employed at other biotechnology or pharmaceutical companies,
including our competitors or potential competitors. To the extent our employees or consultants are involved in research areas
which are similar to those areas in which they were involved at their former employers, we may be subject to claims that such
employees or consultants and/or we have inadvertently or otherwise used or disclosed the alleged trade secrets or other proprietary
information of the former employers. Litigation may be necessary to defend against such claims, which could result in substantial
costs and be a distraction to management and which may have a material adverse effect on us, even if we are successful in defending
such claims.
We also rely on trade secrets, know-how and other proprietary information.
We seek to protect this information, in part, through the use of confidentiality agreements with employees, consultants, advisors
and others. Nonetheless, we cannot assure that those agreements will provide adequate protection for our trade secrets, know-how
or other proprietary information and prevent their unauthorized use or disclosure. The risk that other parties may breach confidentiality
agreements or that our trade secrets become known or independently discovered by competitors, could adversely affect us by enabling
our competitors, who may have greater experience and financial resources, to copy or use our trade secrets and other proprietary
information in the advancement of their products, methods or technologies.
Our success also depends on our JV’s ability to operate
and commercialize products without infringing on the patents or proprietary rights of others.
Third parties may claim that our JV or its licensors or suppliers
are infringing their patents or are misappropriating their proprietary information. In the event of a successful claim against
our JV or its licensors or suppliers for infringement of the patents or proprietary rights of others, our JV may be required to,
among other things:
·
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pay
substantial damages;
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·
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|
stop
using our JV’s technologies;
|
·
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stop
certain research and development efforts;
|
·
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develop
non-infringing products or methods; and
|
·
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obtain
one or more licenses from third parties.
|
A license required under any such patents or proprietary rights
may not be available to our JV, or may not be available on acceptable terms. If our JV or its licensors or suppliers are sued
for infringement, our JV could encounter substantial delays in, or be prohibited from, developing, manufacturing and commercializing
its product candidates.
Our reliance on third party clinical research organizations
and other consultants could have a material effect on our JV’s ability to conduct clinical trials and perform research and
development. Product development costs to our JV and our JV’s potential collaborators will increase, and our JV’s
business may be negatively impacted, if we experience delays in testing or approvals or if our JV needs to perform more or larger
clinical trials than planned.
To obtain regulatory approvals for new products, our JV must, among
other things, initiate and successfully complete multiple clinical trials demonstrating to the satisfaction of the FDA or other
regulatory authority that our JV’s product candidates are sufficiently safe and effective for a particular indication. We
currently rely on third party clinical research organizations and other consultants to assist our JV in designing, administering
and assessing the results of those trials and to perform research and development with respect to product candidates. In relying
on those third parties, we are dependent upon them to timely and accurately perform their services. If third party organizations
do not accurately collect and assess the trial data, our JV may discontinue development of viable product candidates or continue
allocating resources to the development and marketing of product candidates that are not efficacious. Either outcome could result
in significant financial harm to us.
The loss of key management and scientific personnel may hinder
our JV’s ability to execute our business plan.
As a small company our success depends on the continuing contributions
of our management team and scientific consultants, and maintaining relationships with the network of medical and academic centers
in the United States and centers that conduct our clinical trials. We have reduced our staff to two administrative employees and
utilize consultants to perform a variety of administrative, regulatory or research tasks. We have entered into consulting agreements
with various former key employees, but there is no assurance that these persons will be available in the future to the extent
their services may be needed.
If we are not successful in retaining the services of former key
employees it could materially adversely affect our business prospects, including our ability to explore partnering or development
activities.
Our joint venture is managed under contract by Benu BioPharma Inc.,
which is comprised of three individuals (Dennis I. Goldberg, Ph.D., Phillip M. Friden, Ph.D., and Eric M. Morrel, Ph.D.). These
individuals are minority stockholders in our JV.
Although there is a services contract with Benu BioPharma Inc.,
there is no direct agreement with these individuals for continued services and they are under no legal obligation to remain with
Benu BioPharma Inc. We can give no assurance that all or any of these individuals will continue to provide services to our joint
venture. Should any of these individuals not continue to provide services to our joint venture, it could have a material adverse
effect on our joint venture’s ability or cost to develop AEM-28 and its analogs.
Possible side effects of our JV’s product candidates
may be serious and life threatening. If one of our JV’s product candidates reveals safety or fundamental efficacy issues
in clinical trials, it could adversely impact the development path for our JV’s other current product candidates for that
peptide. We face an inherent risk of liability in the event that the use or misuse of our JV’s future products results in
personal injury or death.
The occurrence of any unacceptable side effects during or after
pre-clinical and clinical testing of our JV’s product candidates, or the perception or possibility that our JV’s product
candidates cause or could cause such side effects, could delay or prevent approval of our JV’s products and negatively impact
its business.
The use of our JV’s product candidates in clinical trials may expose us and our JV to product
liability claims, which could result in financial losses. Our clinical liability insurance coverage
may not be sufficient
to cover claims that may be made against us or our JV. In addition, we may not be able to maintain insurance coverage at a reasonable
cost or in sufficient amounts or scope to protect us and our JV against losses. Any claims against us or our JV, regardless of
their merit, could severely harm our financial condition, strain our management and other resources and adversely impact or eliminate
the prospects for commercialization of the product which is the subject of any such claim.
Healthcare reform and restrictions on reimbursements may limit
our financial returns.
Our ability to successfully commercialize our products may depend
in part on the extent to which government health administration authorities, private health insurers and other third party payors
will reimburse consumers for the cost of these products. Third party payors are increasingly challenging both the need for, and
the price of, novel therapeutic drugs and uncertainty exists as to the reimbursement status of newly approved therapeutics. Adequate
third party reimbursement may not be available for our products to enable us to maintain price levels sufficient to realize an
appropriate return on our investments in research and product development, which could restrict our ability to commercialize a
particular product candidate.
Risks Related to our Common Stock
The trading volume in our common stock is limited and our
stock price is volatile, and therefore stockholders may not be able to sell their shares in desired amounts at the reported trading
prices.
The trading price for our common stock, which is traded in the over-the-counter
market, has varied significantly in the past (from a high of $9.32 to a low of $0.10 during the period of January 1, 2004 through
December 31, 2015) and may vary in the future due to a number of factors, including:
·
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the
response by the SEC or the OTCQB Market to our decision not to engage an Independent
Public Accountant to audit and express an opinion on our December 31, 2015 Financial
Statements;
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·
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announcement
of the results of, or delays in, preclinical and clinical studies;
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fluctuations
in our operating results;
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·
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developments
in litigation to which we or a competitor is subject;
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·
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announcements
and timing of potential partnering, development collaboration or licensing transactions,
merger, acquisitions, divestitures, capital raising activities or issuance of preferred
stock;
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·
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announcements
of technological innovations or new products by us or our competitors;
|
·
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FDA
and other regulatory actions;
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·
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developments
with respect to our or our competitors’ patents or proprietary rights;
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public
concern as to the safety of products developed by us or others; and
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·
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changes
in stock market analyst recommendations regarding us, other drug development companies
or the pharmaceutical industry generally.
|
Our common stock is thinly traded, in part because over-the-counter
trading volumes are generally significantly lower than those on stock exchanges. The trading volume for our common stock often
varies widely from day to day. Because of the low trading volume, a relatively small amount of trading may greatly affect the
trading price, the trading price may be subject to amplified decreases upon the occurrence of events affecting our business, and
investors should not consider an investment in our common stock to be liquid. In addition, the broader stock market has from time
to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies,
and these broad market fluctuations may be even more pronounced for our thinly traded stock.
Future share issuances may have dilutive and other material
effects on our stockholders.
We are authorized to issue 150,000,000 shares of common stock. As
of December 31, 2015, there were 40,885,411 shares of common stock issued and outstanding. However, the total number of shares
of our common stock issued and outstanding does not include shares reserved in anticipation of the exercise of options, warrants
or additional investment rights. As of December 31, 2015, we had options outstanding to purchase approximately 4,162,706 shares
of our common stock, the exercise price of which ranges between $0.12 per share to $5.39 per share, warrants outstanding to purchase
46,706 shares of our common stock with an exercise price of $6.39 per share, and warrants outstanding to purchase 117,423 shares
of our common stock with an exercise price of $1.91 per share, and we have reserved shares of our common stock for issuance in
connection with the potential exercise thereof. To the extent additional options are granted and exercised or additional stock
is issued, the holders of our common stock will experience further dilution. At December 31, 2015, 280,000 shares remain available
to grant under the 2015 Equity Incentive Plan.
In addition, in the event that any future financing or consideration
for a future acquisition should be in the form of, be convertible into or exchangeable for, equity securities, investors will
experience additional dilution.
Certain provisions of our certificate of incorporation and
bylaws will make it difficult for stockholders to change the composition of our board of directors(“Board”) and may
discourage takeover attempts that some of our stockholders may consider beneficial.
Certain provisions of our certificate of incorporation and bylaws
may have the effect of delaying or preventing changes in control if our Board determines that such changes in control are not
in the best interests of the Company and our stockholders. These provisions include, among other things, the following:
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a
classified Board with three-year staggered terms;
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·
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advance
notice procedures for stockholder proposals to be considered at stockholders’ meetings;
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the
ability of our Board to fill vacancies on the board;
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a
prohibition against stockholders taking action by written consent;
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supermajority
voting requirements for the stockholders to modify or amend our bylaws and specified
provisions of our certificate of incorporation, and
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the
ability of our Board to issue up to 2,000,000 shares of preferred stock without stockholder
approval.
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These provisions are not intended to prevent a takeover, but are
intended to protect and maximize the value of our stockholders’ interests. While these provisions have the effect of encouraging
persons seeking to acquire control of our company to negotiate with our Board, they could enable our Board to prevent a transaction
that some, or a majority, of our stockholders might believe to be in their best interests and, in that case, may prevent or discourage
attempts to remove and replace incumbent directors. In addition, we are subject to the provisions of Section 203 of the Delaware
General Corporation Law, which prohibits business combinations with interested stockholders. Interested stockholders do not include
stockholders whose acquisition of our securities is pre-approved by our Board under Section 203.
In June 2014, our Board adopted a Tax Benefit Preservation Plan
(“Benefit Plan”) with Computershare, pursuant to which each outstanding share of our common stock has attached one
preferred stock purchase right. Each share of our common stock subsequently issued prior to the expiration of the Benefit Plan
will likewise have attached one right. Under specified circumstances involving an “ownership change,” as defined in
Section 382 of the Internal Revenue Code (the “Code”), the right under the Benefit Plan that attaches to each share
of our common stock will entitle the holder thereof to purchase 1/100 of a share of our Series A preferred stock for a purchase
price of $5.00 (subject to adjustment), and to receive, upon exercise, shares of our common stock having a value equal to two
times the exercise price of the right.
By adopting the Benefit Plan, our Board sought to protect our ability
to use our net operating loss carryforwards and other tax attributes to reduce our future taxable income, if any (collectively,
“Tax Benefits”). We view our Tax Benefits as highly valuable assets that are likely to inure to our benefit and the
benefit of our stockholders if in the future we generate taxable income. However, if we experience an “ownership change,”
our ability to use the Tax Benefits could be substantially limited, and the timing of the usage of the Tax Benefits could be substantially
delayed, which could significantly impair the value of the Tax Benefits. The Benefit Plan is intended to act as a deterrent to
persons acquiring our common stock in certain transactions that would constitute or contribute to such an “ownership change”
without the approval of our Board. The Benefit Plan expires June 24, 2016.
We may issue additional shares of preferred stock that have
greater rights than our common stock and also have dilutive and anti-takeover effects.
We have 2,000,000 shares of authorized preferred stock, the terms
of which may be fixed by our Board. We presently have no outstanding shares of preferred stock. Our Board has the authority, without
stockholder approval, to create and issue one or more series of such preferred stock and to determine the voting, dividend and
other rights of holders of such preferred stock. If we raise additional funds to continue development of AEM-28 and its analogs,
or operations, we may issue preferred stock. The issuance of any of such series of preferred stock may have an adverse effect
on the holders of common stock.
In connection with the Benefit Plan, our Board approved the designation
of 1,000,000 shares of Series A Preferred Stock. The Benefit Plan and the exercise of rights to purchase Series A Preferred Stock,
pursuant to the terms thereof, may delay, defer or prevent a change in control without the approval of the Board. In addition
to the anti-takeover effects of the rights granted under the Benefit Plan, the issuance of preferred stock, generally, could have
a dilutive effect on our stockholders. The Benefit Plan expires June 24, 2016.
We have not previously paid dividends on our common stock
and we do not anticipate doing so in the foreseeable future.
We have not in the past paid any dividends on our common stock and
do not anticipate that we will pay any dividends on our common stock in the foreseeable future. Any future decision to pay a dividend
on our common stock and the amount of any dividend paid, if permitted, will be made at the discretion of our Board.
The development of Apo E mimetic peptide molecule AEM-28 and
its analogs by our joint venture may not result in a liquidity event or a liquidity event, if one occurs, may be insufficient
in size and our investment in LipimetiX Development, Inc. may not be recovered.
On August 3, 2012, we entered into a joint venture with LipimetiX,
LLC (now LipimetiX Development, Inc.) to develop the Apo E mimetic molecule AEM-28 and its analogs and we contributed $6 million
to the joint venture and at December 31, 2015 we have loaned an additional $1.5 million to the joint venture. Our cash contribution
to the joint venture represents a substantial proportion of our available cash.
The initial funded development plan was focused on the development
of treatments using AEM-28 for Homozygous Familial Hypercholesterolemia and Refractory Hypercholesterolemia and extended through
Phase 1a and 1b/2a clinical trials, which were completed in the 4
th
quarter of 2014. Our pre-clinical studies or clinical
trials results may not be viewed by potential partners, licensees or acquirers, as successful, and we may not recover our investment.
Even if our development efforts are viewed as successful, a liquidity event, if any, may be insufficient in size to recover our
investment.
Our joint venture is unable to continue additional development
of AEM-28 or its analogs without additional funding support and the Company does not have sufficient funds to continue either
its operations or development funding, which may impair the ability of the joint venture or the Company to continue on a going
concern basis.
There is no assurance that we will have adequate funds available,
or that we can obtain needed funding from third parties on terms acceptable to us, or at all. If the joint venture cannot complete
its development work as planned due to a lack of funds, the value of our investment would be impaired, perhaps materially, as
would be our ability to continue as a going concern.
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
We lease office space in a facility in Tempe, Arizona, which is
an approximately 100,000 square foot facility designed and constructed for industrial purposes and is located in an industrial
district. In July 2007, we entered into a five-year lease for 17,000 square feet of space in this Tempe facility, which became
effective March 1, 2008. We amended this lease, effective March 1, 2013, to extend the lease for two additional years and reduce
the square feet rented to 2,845. On October 1, 2014 we amended this lease to extend the term to February 29, 2016 and on February
8, 2016, we extended this lease term to February 28, 2017. We believe the facility is well-maintained and adequate for use through
the end of our lease term.
Item 3. Legal Proceedings
In June 2015, we settled our long-pending qui tam lawsuit for a
one-time payment of $50,000. The lawsuit had been filed under seal by Jeffrey J. Bierman, as Relator/Plaintiff, on March 28, 2005
in the United States District Court for the District of Massachusetts against us and substantially all sellers of bone growth
stimulation devices during the period 1998-2003. The complaint asserted a variety of claims, including False Claims Act violations.
We sold our bone growth stimulation device business in 2003 and first learned of this lawsuit in September 2009.
Item 4. Mine Safety Disclosures
None.
PART II
Item 5. Market for Registrant’s Common
Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market Information
Our common stock commenced trading
on Nasdaq on January 28, 1993 and was delisted by Nasdaq on July 21, 2011. Our common stock is currently traded on the OTCQB under
the symbol “CAPS.” The following table sets forth, for the fiscal periods indicated, the range of high and low sales
prices of our common stock.
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2015
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2014
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High
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Low
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High
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|
Low
|
First Quarter
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$
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0.24
|
|
|
$
|
0.17
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|
|
$
|
0.38
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|
$
|
0.24
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Second Quarter
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$
|
0.25
|
|
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$
|
0.13
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|
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$
|
0.33
|
|
|
$
|
0.21
|
|
Third Quarter
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$
|
0.24
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|
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$
|
0.15
|
|
|
$
|
0.39
|
|
|
$
|
0.21
|
|
Fourth Quarter
|
|
$
|
0.17
|
|
|
$
|
0.10
|
|
|
$
|
0.27
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|
|
$
|
0.19
|
|
As of March 15, 2016, 40,885,411 shares of our common stock were
outstanding and held by approximately 754 stockholders of record.
Dividends
We have never paid a cash dividend on our common stock. We do not
intend to pay any cash dividends on our common stock in the foreseeable future.
Recent Sales of Unregistered Securities
None.
Issuer Purchases of Equity Securities
None.
Securities Authorized for Issuance under Equity Compensation Plan
The information required by Item 201(d) of Regulations S-K is provided
under Item 12, Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters, which is incorporated
herein by reference.
Item 6. Selected Financial Data
N/A
Item 7. Management’s Discussion and
Analysis of Financial Condition and Results of Operations
OVERVIEW OF BUSINESS
Company History
Prior to November 2003, we developed, manufactured and marketed
proprietary, technologically advanced orthopedic products designed to promote the healing of musculoskeletal bone and tissue,
with particular emphasis on fracture healing and spine repair. Our product lines, which included bone growth stimulation and fracture
fixation devices, are referred to as our “Bone Device Business.” In November 2003, we sold our Bone Device Business.
In August 2004, we purchased substantially all of the assets and
intellectual property of Chrysalis Biotechnology, Inc. (“CBI”), including its exclusive worldwide license for Chrysalin
for all medical indications. Subsequently, our efforts were focused on research and development of Chrysalin with the goal of
commercializing our products in fresh fracture healing. (In March 2012, we returned all rights to the Chrysalin intellectual property
and no longer have any interest in, or rights to Chrysalin.)
In February 2006, we purchased certain assets and assumed certain
liabilities of AzERx, Inc. Under the terms of the transaction, we acquired an exclusive license for the core intellectual property
relating to AZX100, an anti-fibrotic peptide. In 2014, we terminated the License Agreement with AzTE (Licensor) for the core intellectual
property relating to AZX100 and returned all interest in and rights to the AZX100 intellectual property to the Licensor.
On August 3, 2012, we entered into a joint venture, LipimetiX Development,
LLC (now LipimetiX Development, Inc.), (see Note 9 in Notes to Financial Statements included in this Annual Report on Form 10-K
for more information) to develop Apo E mimetic peptide molecule AEM-28 and analogs.
Our development activities represent a single operating segment
as they shared the same product development path and utilized the same Company resources. As a result, we determined that it is
appropriate to reflect our operations as one reportable segment.
OrthoLogic Corp. commenced doing business under the trade name of
Capstone Therapeutics on October 1, 2008, and we formally changed our name from OrthoLogic Corp. to Capstone Therapeutics Corp.
on May 21, 2010.
In this Annual Report on Form 10-K, references to “we”,
“our”, the “Company”, “Capstone Therapeutics”, “Capstone”, and “OrthoLogic”
refer to Capstone Therapeutics Corp. References to our Bone Device Business refer to our former business line of bone growth stimulation
and fracture fixation devices, including the OL1000 product line, SpinaLogic®, OrthoFrame® and OrthoFrame/Mayo. References
to our joint venture, or the “JV”, refer to LipimetiX Development, Inc. (previously LipimetiX, LLC).
Description of the business
Capstone Therapeutics Corp. (the “Company” or “we”)
is a biotechnology company committed to developing a pipeline of novel peptides and other molecules aimed at helping patients
with under-served medical conditions. Previously, we were focused on the development and commercialization of two product platforms:
AZX100 and Chrysalin (TP508). Since March 2012, we no longer have any interest in or rights to Chrysalin. In 2012 we wound down
internal research operations, ceased clinical development of AZX100 in dermal scarring, formerly our principal drug candidate,
and moved to a more virtual operating model. In 2014, we terminated the License Agreement for AZX100 intellectual property and
returned all interest in and rights to the AZX100 intellectual property to the Licensor (AzTE).
On August 3, 2012, we entered into a joint venture, LipimetiX Development,
LLC (now LipimetiX Development, Inc.), (the “JV”) to develop Apo E mimetic peptide molecule AEM-28 and its analogs.
The JV has a development plan to pursue regulatory approval of AEM-28, or an analog, as treatment for Homozygous Familial Hypercholesterolemia
(granted Orphan Drug Designation by FDA in 2012), AP, diabetic dyslipidemia and other hyperlipidemic indications. The initial
development plan extended through Phase 1a and 1b/2a clinical trials and was completed in the fourth quarter of 2014. The clinical
trials have a safety primary endpoint and an efficacy endpoint targeting reduction of cholesterol and triglycerides.
In early 2014, the JV received allowance from regulatory authorities
in Australia permitting the JV to proceed with the planned clinical trials. The Phase 1a clinical trial commenced in Australia
in April 2014 and the Phase 1b/2a clinical trial commenced in Australia in June 2014. The clinical trials for AEM-28 are randomized,
double-blinded, placebo-controlled studies to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of six
escalating single doses (Phase 1a in healthy patients with elevated cholesterol) and multiple ascending doses of the three highest
doses from Phase 1a (Phase 1b/2a in patients with hyper-cholesterolemia and healthy subjects with elevated cholesterol and high
Body Mass Index). The Phase 1a clinical trial consisted of 36 patients and the Phase 1b/2a consisted of 15 patients. Both clinical
trials were completed in 2014 and the Medical Safety Committee, reviewing all safety-related aspects of the clinical trials, observed
a generally acceptable safety profile. As first-in-man studies, the primary endpoint was safety; yet efficacy measurements analyzing
pharmacodynamics yielded statistical significance in the pooled dataset favoring AEM-28 versus placebo in multiple lipid biomarker
endpoints.
Concurrent with the development activities for AEM-28, the JV has
performed limited pre-clinical studies that have identified analogs of AEM-28, including one referred to as AEM-28-14, that have
the potential of increased efficacy, higher human dose toleration and an extended composition of matter patent life. The JV has
a development plan to pursue regulatory approval and commercialization of AEM-28, or one or more of its analogs, as treatment
in orphan (rare disease) indications, including AP and HoFH, and potentially in acute coronary syndrome, peripheral artery disease
and metabolic syndrome. HoFH has been designated by the FDA as an orphan indication. We believe that AP may also qualify for orphan
indication designation.
The JV and Company are exploring fundraising, partnering or licensing
to obtain additional funding to continue development activities of AEM-28 and AEM-28-02.
The JV and the Company do not have sufficient funding at this time
to continue additional material development activities of AEM-28 and its analogs or operations. The JV may conduct future clinical
trials in Australia, the USA, and other regulatory jurisdictions if regulatory approvals, additional funding, and other conditions
permit. The JV may also fund research or studies to investigate AEM-28-14 and for treatment of acute coronary syndrome and other
indications.
The Company, funding permitting, intends to continue limiting its
internal operations to a virtual operating model while monitoring and participating in the management of LipimetiX Development,
Inc’s AEM-28 and analogs development activities. We intend to maintain the required level of corporate governance and reporting
that would be required to comply with Securities and Exchange Commission (“SEC”) rules and regulations, except that
effective with the filing of this Annual Report on Form 10-K without the opinion or an Independent Public Accountant, we will
not be in compliance with SEC Rules and Regulations or OTCQB Market listing requirements.
Description of Our Peptide Drug Candidates.
Chimeric Apo E Mimetic Peptide Molecule – AEM-28 and its
analogs
Apolipoprotein E is a 299 amino acid protein that plays an important
role in lipoprotein metabolism. AEM-28 is a 28 amino acid mimetic of Apo E and AEM-28-14 (an analog of AEM-28) is a 28 amino acid
mimetic of Apo E (with an aminohexanoic acid group and a phospholipid) and both contain a domain that anchors into a lipoprotein
surface while also providing the Apo E receptor binding domain, which allows clearance through the heparan sulfate proteoglycan
(HSPG) receptors (Syndecan-1) in the liver. AEM-28 and AEM-28-14, as Apo E mimetics, have the potential to restore the ability
of these atherogenic lipoproteins to be cleared from the plasma, completing the reverse cholesterol transport pathway, and thereby
reducing cardiovascular risk. This is an important mechanism of action for AEM-28 and AEM-28-14. For patients that lack LDL receptors
(Homozygous Familial Hypercholesterolemia-HoFH), have acute pancreatitis, or have hypercholesterolemia, AEM-28 or AEM-28-14 may
provide a therapeutic solution. Our joint venture has an Exclusive License Agreement with the University of Alabama at Birmingham
Research Foundation for AEM-28 and certain of its analogs.
_________________________________
Critical Accounting Policies and Estimates
The preparation of financial statements in accordance with accounting
principles generally accepted in the United States of America requires that management make a number of assumptions and estimates
that affect the reported amounts of assets, liabilities, and expenses in our financial statements and accompanying notes. Management
bases its estimates on historical experience and various other assumptions believed to be reasonable. Although these estimates
are based on management’s best knowledge of current events and actions that may impact the Company in the future, actual
results may differ from these estimates and assumptions. Our critical accounting policies are those that affect, or could affect
our financial statements materially and involve a significant level of judgment by management.
Income Taxes:
Accounting Standards Codification Topic 740
“Income Taxes” requires that a valuation allowance be established when it is more likely than not that all or a portion
of a deferred tax asset will not be realized. Changes in valuation allowances from period to period are included in the tax provision
in the period of change. In determining whether a valuation allowance is required, we take into account all evidence with regard
to the utilization of a deferred tax asset, including past earnings history, expected future earnings, the character and jurisdiction
of such earnings, unsettled circumstances that, if unfavorably resolved, would adversely affect utilization of a deferred tax
asset, carryback and carryforward periods, and tax strategies that could potentially enhance the likelihood of realization of
a deferred asset. We have evaluated the available evidence about future taxable income and other possible sources of realization
of deferred tax assets and have established a valuation allowance for all of our deferred tax assets of approximately $57 million
at December 31, 2015.
In March 2014, LipimetiX Development, LLC, now LipimetiX Development,
Inc., (see Note 9 in the Financial Statements included in this Annual Report on Form 10-K for more information) formed a wholly-owned
Australian subsidiary, Lipimetix Australia Pty Ltd, to conduct Phase 1a and Phase1b/2a clinical trials in Australia. Currently
Australian tax regulations provide for a refundable research and development tax credit equal to 45% of qualified expenditures.
Subsequent to the end of its Australian tax years, Lipimetix Australia Pty Ltd intends to submit claims for a refundable research
and development tax credit. The transitional Australian tax periods/years granted for Lipimetix Australia Pty Ltd end on June
30, 2014, December 31, 2014 and thereafter December 31 of each succeeding year. For the tax period ended June 30, 2014, Lipimetix
Australia Pty Ltd received a refundable research and development tax credit of AUD$227,000. For the tax period ended December
31, 2014 a refundable research and development tax credit of AUD$301,000 was received by LipimetiX Australia Pty Ltd. At December
31, 2015, a refundable research and development tax credit of AUD$189,000 has been accrued, as it is more likely than not, that
the recorded refundable research and development tax credit at December 31, 2015 will be approved and received.
Patents:
Patent license rights were recorded at $1,045,000,
their estimated fair value on the date they were acquired, August 3, 2012. Their cost is amortized on a straight-line basis over
the key patent life of eighty months. At December 31, 2015, accumulated amortization totaled $536,000. If a change in conditions
occurs, that indicates a material change in the future utility of the patent license rights, an evaluation will be performed to
determine if impairment of the asset has occurred, and if so, the impairment will be recorded. Future utility of the patent license
rights is dependent upon the Company’s ability to raise additional funding to continue development of AEM-28 and its analogs
or to complete a sale, licensing or other transactions.
Legal and Other Contingencies:
As discussed in Part I, Item 3
of this Form 10-K under the heading “Legal Proceedings” and in Note 10, “Contingency – Legal Proceedings”
in Notes to Financial Statements, the Company is subject to legal proceedings and claims that arise in the course of business.
The Company records a liability when it is probable that a loss has been incurred and the amount is reasonably estimable. There
is significant judgment required in both the probability determination and as to whether an exposure can be reasonably estimated.
In the opinion of management, there was not at least a reasonable possibility the Company may have incurred a material loss with
respect to loss contingencies.
As discussed in Note 9, “Joint Venture for Development of
Apo E Mimetic Peptide Molecule AEM-28 and Analogs” in Notes to Financial Statements included in this Annual Report on Form
10-K, the Company entered into a joint venture in which it has contributed $6,000,000, and the noncontrolling interests have contributed
certain patent license rights. Neither the Company nor the noncontrolling interests have an obligation to contribute additional
funds to the joint venture or to assume any joint venture liabilities or to provide a guarantee of either joint venture performance
or any joint venture liability. The financial position and results of operations of the joint venture are presented on a consolidated
basis with the financial position and results of operations of the Company. Intercompany transactions have been eliminated. Joint
venture losses will be recorded on the basis of common ownership equity interests (60% Company / 40% noncontrolling interests)
until common ownership equity is reduced to $0. Subsequent joint venture losses will be allocated to the preferred ownership equity
(100% Company). Subsequent to March 31, 2013, all joint venture losses are being allocated to the Company. The Company has a revolving
loan agreement with the joint venture to advance the joint venture funds for operations in an amount not to exceed a net (net
of expected tax credits or other funds obtained) of $1,400,000, with the net amount due December 31, 2016. Losses incurred by
the joint venture in excess of the capital accounts of the joint venture will be allocated to the Company to the extent of net
outstanding advances. At December 31, 2015, outstanding advances on the revolving loan agreement totaled $1,510,000.
Losses allocated to the noncontrolling interests represent an additional
potential loss for the Company as the noncontrolling interests are not obligated to contribute assets to the joint venture to
the extent they have a negative capital account and depending on the ultimate outcome of the joint venture, the Company could
potentially absorb all losses associated with the joint venture. At December 31, 2015, losses totaling $667,000 have been allocated
to the noncontrolling interests. The Company records a contingent loss when it is probable that a loss has been incurred and the
amount is reasonably estimable. There is significant judgment required in both the probability determination and as to whether
an exposure can be reasonably estimated. In the opinion of management, there was not at least a reasonable possibility the Company
may have incurred a material loss with respect to this loss contingency.
Fair value measurements:
We determine the fair value measurements
of our applicable assets and liabilities based on a three-tier fair value hierarchy, which prioritizes the inputs used in measuring
fair value. These tiers include: Level 1, defined as observable inputs such as quoted market prices in active markets; Level 2,
defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined
as unobservable inputs for which little or no market data exists, therefore requiring an entity to develop its own assumptions.
Stock based compensation:
Effective January 1, 2006, we adopted
SFAS No. 123 (revised 2004), “Share-Based Payment”, now Accounting Standards Codification Topic 718 “Stock Compensation”
(“ASC 718”). ASC 718 requires all share-based payments, including grants of stock options, restricted stock units
and employee stock purchase rights, to be recognized in our financial statements based on their respective grant date fair values.
Under this standard, the fair value of each employee stock option and employee stock purchase right is estimated on the date of
grant using an option pricing model that meets certain requirements. We currently use the Black-Scholes option pricing model to
estimate the fair value of our share-based payments. The determination of the fair value of share-based payment awards utilizing
the Black-Scholes model is affected by our stock price and a number of assumptions, including expected volatility, expected life,
risk-free interest rate and expected dividends. We use the historical volatility adjusted for future expectations. The expected
life of the stock options is based on historical data and future expectations. The risk-free interest rate assumption is based
on observed interest rates appropriate for the terms of our stock options and stock purchase rights. The dividend yield assumption
is based on our history and expectation of dividend payouts. The fair value of our restricted stock units is based on the fair
market value of our common stock on the date of grant. Stock-based compensation expense recognized in our financial statements
in 2006 and thereafter is based on awards that are ultimately expected to vest. We recognize compensation cost for an award with
only service conditions that has a graded vesting schedule on a straight line basis over the requisite service period as if the
award was, in-substance, a multiple award. However, the amount of compensation cost recognized at any date must at least equal
the portion of grant-date fair value of the award that is vested at that date. For non-employees, this expense is recognized as
the service is provided in accordance with ASC Topic 505-550 “Equity-Based Payments to Non-Employees.” The amount
of stock-based compensation expense in 2006 and thereafter is reduced for estimated forfeitures. Forfeitures are required to be
estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
We evaluate the assumptions used to value stock awards on a quarterly basis. If factors change and we employ different assumptions,
stock-based compensation expense may differ significantly from what we have recorded in the past.
ASC 718 requires the benefits associated with tax deductions that
are realized in excess of recognized compensation cost to be reported as a financing cash flow rather than as an operating cash
flow as previously required. Subsequent to the adoption of ASC 718 on January 1, 2006, we have not recorded any excess tax benefit
generated from option exercises, due to our net operating loss carryforwards, which cause such excess to be unrealized.
Joint Venture Accounting:
As discussed in Note 9 to Financial
Statements included in this Form 10-K, “Joint Venture for Development of Apo E Mimetic Peptide Molecule AEM-28 and Analogs”,
the Company entered into a joint venture in which it has contributed $6,000,000, and the noncontrolling interests have contributed
certain patent license rights. Neither the Company nor the noncontrolling interests have an obligation to contribute additional
funds to the joint venture or to assume any joint venture liabilities or to provide a guarantee of either joint venture performance
or any joint venture liability. The financial position and results of operations of the joint venture are presented on a consolidated
basis with the financial position and results of operations of the Company. Intercompany transactions have been eliminated. Joint
venture losses will be recorded on the basis of common ownership equity interests (60% Company / 40% noncontrolling interests)
until common ownership equity is reduced to $0. Subsequent joint venture losses will be allocated to the preferred ownership equity
(100% Company). Subsequent to March 31, 2013, all joint venture losses are being allocated to the Company. The Company has a revolving
loan agreement with the joint venture to advance the joint venture funds for operations in an amount not to exceed a net (net
of expected tax credits or other funds obtained) of $1,400,000, with the net amount due December 31, 2016. Losses incurred by
the joint venture in excess of the capital accounts of the joint venture will be allocated to the Company to the extent of net
outstanding advances.
Recent Accounting Pronouncements
In August 2014, the Financial Accounting
Standards Board issued Accounting Standard Update (“ASU”) No. 2014-15,
Presentation of Financial Statements
– Going Concern (Subtopic 205-40)(“Update”): Disclosure of Uncertainties about an Entity’s Ability to
Continue as a Going Concern, providing a requirement under U.S. GAAP for an entity’s management to evaluate whether there
are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue
as a going concern within one year after the date the financial statements are issued; and if those conditions exist, to disclose
that fact, the conditions and the potential effects on the entity’s ability to meet its obligations. The Update will be
effective for an annual period ending after December 15, 2016, with early application permitted
. We have not elected early
application. However, if additional funds are not obtained to continue the development of AEM-28 or its analogs, or operations,
it will impair our ability to continue as a going concern. If we do not continue as a going concern, the Company may incur additional
losses, up to, and possibly exceeding our net joint venture investment and revolving loan balance.
Results of Operations Comparing Year Ended December 31, 2015 and 2014.
General and Administrative (“G&A”) Expenses:
G&A expenses related to our ongoing operations were $1,757,000 in 2015 compared to $1,453,000 in 2014. Administration
expenses increased primarily due to costs related to the
qui tam
litigation, preparation and filing of a Registration Statement
filed on Form S-1, and investor relations activities.
Research and Development Expenses:
Research and development
expenses were $1,182,000 for 2015 compared to $3,071,000 for 2014. Our research and development expenses in 2015 and 2014 included
the operating expenses of LipimetiX Development, LLC, which totaled (net of intercompany transactions) $904,000 for 2015, and
$2,354,000 for 2014. The joint ventures’ initial planned research activities were substantially completed as of December
31, 2014 and in 2015 limited work was performed.
Interest and Other Expenses (Income), Net:
Interest and Other
Expenses (Income), Net, decreased from $43,000 in 2014 to $24,000 in 2015 due to the receipt of $60,000 in 2014 from the conversion
of an insurance company, in which we were a policyholder, from mutual to private ownership, with this income offset by a foreign
exchange loss of $120,000 related to our joint ventures’ Australian activities. In 2015 the foreign exchange loss was $28,000.
Income Tax Benefit:
Income tax benefit in 2015 and 2014 consisted
of a refundable Australian research and development tax credit, as described in Notes 4 and 7 to the financial statements included
in this Annual Report on Form 10-K, related to our joint ventures’ Australian clinical trial activities.
Net Loss attributable to Capstone Therapeutics stockholders
:
We incurred a net loss in 2015 of $2.8 million compared to a net loss of $4.2 million in 2014. Net loss includes operations of
LipimetiX Development, LLC, which totaled (net of intercompany transactions) $904,000 for 2015, and $2,354,000 for 2014. The joint
ventures’ initial planned research activities have been substantially completed as of December 31, 2014.
Results of Operations Comparing Year Ended December 31, 2014 and 2013.
General and Administrative (“G&A”) Expenses:
G&A expenses related to our ongoing operations were $1,453,000 in 2014 compared to $1,169,000 in 2013. Administration
expenses increased primarily due to costs related to the
qui tam
litigation, and investor relations activities.
Research and Development Expenses:
Research and development
expenses were $3,071,000 for 2014 compared to $3,124,000 for 2013. Our research and development expenses in 2014 and 2013 included
the operating expenses of LipimetiX Development, LLC, which totaled (net of intercompany transactions) $2,354,000 for 2014, and
$2,652,000 for 2013. The joint ventures’ initial planned research activities have been substantially completed as of December
31, 2014.
Interest and Other Expenses (Income), Net:
Interest and Other
Expenses (Income), Net, decreased from $158,000 of Income in 2013 to $43,000 of Expense in 2014 due to the receipt of $152,000
in the first quarter of 2013 from the conversion of an insurance company, in which we were a policyholder, from mutual to private
ownership versus $60,000 in 2014. In 2014 this income was offset by a foreign exchange loss of $120,000 related to our joint ventures’
Australian activities.
Income Tax Benefit:
Income tax benefit in 2014 consisted
of a $400,000 refundable Australian research and development tax credit, as described in Notes 4 and 7 to the financial statements
included in this Annual Report on Form 10-K, related to our joint ventures’ Australian clinical trial activities.
Net Loss attributable to Capstone Therapeutics stockholders
:
We incurred a net loss in 2014 of $4.2 million compared to a net loss of $3.9 million in 2013. Net loss includes operations of
LipimetiX Development, LLC, which totaled (net of intercompany transactions) $2,354,000 for 2014, and $2,652,000 for 2013, net
of net loss allocated to noncontrolling interests of $0 for 2014 and $193,000 for 2013. The joint ventures’ initial planned
research activities have been substantially completed as of December 31, 2014.
Liquidity and Capital Resources
With the sale of our Bone Device Business in November 2003, we sold
all of our revenue producing operations. Since that time, we have primarily relied on our cash and investments to finance all
our operations, the focus of which has been research and development of our product candidates.
On August 3, 2012, we entered into a joint venture, LipimetiX Development,
LLC (“JV”) to develop Apo E mimetic peptide molecule AEM-28 and its analogs and we contributed $6.0 million through
December 31, 2015 we have loaned an additional $1,510,000 to the JV. At December 31, 2015, we had cash and cash equivalents of
$1.0 million.
We plan to continue our plan to limit internal operations in a virtual
operating model in 2015, however, without additional funding, we will not continue development of AEM-28 and its analogs past
completion of the limited projects currently under way. We are exploring strategic options for both the Company and our joint
venture. Lack of additional funding within the next 12 months, would impair our ability to continue our current operations and
our ability to continue as a going concern..
Funding permitting, our planned operations in 2015 consist of monitoring
and participating in the management of LipimetiX Development LLC’s AEM-28 and its analogs development activities.
Our future research and development and other expenses will vary
significantly from prior periods and depend on the Company’s decisions on future LipimetiX Development, Inc. operations
and obtaining additional funding.
We will require additional funds if we chose to extend the development
of AEM-28 and its analogs to continue operations. We cannot currently predict the amount of funds that will be required if we
chose to extend the development activities of AEM-28 and its analogs and to continue operations. In any event, to complete the
clinical trials and supporting research and production efforts necessary to obtain FDA or comparable foreign agencies’ approval
for product candidates would require us to obtain additional capital. New sources of funds, including raising capital through
the sales of our debt or equity securities, joint venture or other forms of joint development arrangements, sales of development
rights, or licensing agreements, may not be available or may only be available on terms that would have a material adverse impact
on our existing stockholders’ interests.
As discussed in Note 10 to the Financial Statement included in this
Annual Report on Form 10-K, the Company received loans totaling $1,000,000 from entities that currently own approximately 19%
of the Company’s common stock. If not converted into shares of the Company’s common stock, the loans would be due
April 30, 2017.
Item 7A. Quantitative and Qualitative Disclosures about Market
Risk
Our investment portfolio is used to preserve our capital until it
is required to fund our operations. We do not hold any derivative financial instruments in our investment portfolio. We maintain
a non-trading investment portfolio of investment grade securities that limits the amount of non-U.S. government obligations credit
exposure of any one issue, issuer or type of instrument. Due to the short duration and conservative nature of these instruments,
we do not believe that we have a material exposure to interest rate risk.
Item 8. Financial Statements and Supplementary
Data
Consolidated balance sheets as of December 31, 2015 and December
31, 2014, consolidated statements of operations, changes in equity and cash flows for each of the years in the two-year period
ended December 31, 2015, together with the related notes are set forth on the “F” pages of this Form 10-K.
Item 9. Changes
in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures
Our management, with the participation of our principal executive
officer and principal financial and accounting officer, has reviewed and evaluated our disclosure controls and procedures
(as defined in the Securities Exchange Act Rule 13a-15(e)) as of the end of the period covered by this Form 10-K. Based on
that evaluation, our management, including our principal executive officer and principal financial and accounting officer, has
concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Form 10-K in
ensuring that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of
1934 is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s
rules and forms and is accumulated and communicated to management, including our principal executive officer and principal financial
and accounting officer, as appropriate, to allow timely decisions regarding required disclosure.
Management’s Annual Report on Internal Control Over Financial Reporting
The management of Capstone Therapeutics Corp is responsible for
establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a
- 15(f). Under the supervision and with the participation of our management, including our principal executive officer and principal
financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the
framework in the 1992 Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission. Based on our evaluation under the framework in the 1992 Internal Control - Integrated Framework, our management concluded
that our internal control over financial reporting was effective as of December 31, 2015.
This annual report does not include an attestation report of the
Company’s independent registered public accounting firm regarding internal control over financial reporting. Management’s
report was not subject to attestation by the Company’s registered public accounting firm pursuant to rules of the Securities
Exchange Commission that permit the Company to provide only management’s report in this annual report.
Management’s Report on Changes in Internal Controls Over Financial Reporting
There were no changes in our internal controls over financial reporting
during the fiscal quarter ended December 31, 2015, that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
Item 9B. Other Information
None.
PART III
Item 10. Directors, Executive Officers and Corporate
Governance
INFORMATION CONCERNING DIRECTORS
On April 28, 2014, the Board of Directors increased the number of
directors to four and Eric W. Fangmann was elected to fill the fourth Board seat at the Company’s Annual Meeting held on
June 12, 2014. On March 15, 2016, Mr. Fangmann resigned from the Board of Directors. On March 18, 2016, the Board of Directors
decreased the number of Directors to three.
John M. Holliman, III
John M. Holliman III, 62, has served as Executive Chairman and Principal
Executive Officer of the Company since April 2006 and has served as a director of the Company since September 1987 and as Chairman
of the Board of Directors since August 1997. Since February 1993 he has been a general partner of entities which are the general
partners of Valley Ventures, LP (formerly known as Arizona Growth Partners, LP), Valley Ventures II, LP, Valley Ventures III,
LP, Valley Ventures III Annex, LP, all of which are venture capital funds that invest principally in life science companies.
John M. Holliman, III has over thirty years of business experience,
including service on the boards of over forty companies, commercial lending experience with major financial institutions, and
has been active in venture capital financing for over thirty years, concentrating in the medical/biotech industries. Mr. Holliman
earned a BBA in Finance and a MBA from Southern Methodist University and a Master of International Management from the Thunderbird
School of Global Management. During his career Mr. Holliman has gained substantial executive and board level experience in business,
finance and operations. The Board believes the experience and knowledge of Mr. Holliman qualifies him to serve on our board.
Eric W. Fangmann (1)
Eric W. Fangmann, age 46, has served as a director of the Company
since June 2014. On March 15, 2016, Mr. Fangmann resigned from the Board of Directors. Mr. Fangmann has been the Chief Financial
Officer for Lloyd I. Miller, III, since 2011. Mr. Fangmann is also the Acting President and Acting Chief Financial Officer for
Pharmos Corporation, a pharmaceutical company, since 2012. Mr. Fangmann was previously an independent accounting and finance consultant
who was principally engaged by public and private entities to assist in independent analysis and other projects. Mr. Fangmann
was appointed by the Board of Directors of Synergy Brands Inc. in 2011 as its chief financial officer and treasurer, and was appointed
as officer and/or director of certain of its subsidiaries, to serve in such capacities on an interim basis in connection with
certain filings under Chapter 7 of the U.S. bankruptcy code. From 2005 to 2010, Mr. Fangmann served as Executive Vice President
Technology of Frontera Investment, Inc., a publicly held cash and loan company. Prior to that, Mr. Fangmann has served principally
in senior management accounting and finance functions for both public and private entities such as The Upper Deck Company, LLC,
PriceSmart, Inc. and Teletrac, Inc. From 1992 to 1996, Mr. Fangmann worked in the audit division of Arthur Andersen. Mr. Fangmann
also serves on the board of directors of Alliance Semiconductor and Global Agora, LLC. Mr. Fangmann holds a B.S. in Accountancy
- Cum Laude from the University of Missouri, Columbia, Missouri.
Mr. Fangmann was introduced and recommended to the Board as a nominee
for director by Lloyd I. Miller, III, a significant shareholder. The Board believes Mr. Fangmann’s diverse financial experience
brings important experience to the Board and qualifies him to serve on our Board.
Fredric J. Feldman, Ph.D. (1) (2) (3)
Fredric J. Feldman, Ph.D., 75, has been the President of FJF Associates,
a consultant to health care venture capital and emerging companies, since February 1992 and has served as a director of the Company
since 1991. From September 1995 to June 1996, he was the Chief Executive Officer of Biex, Inc., a women’s healthcare company.
He served as Chief Executive Officer of Oncogenetics, Inc., a cancer genetics reference laboratory, from 1992 to 1995. Between
1988 and 1992, Dr. Feldman was the President and Chief Executive Officer of Microgenics Corporation, a medical diagnostics company.
Dr. Feldman received his Ph.D. in analytical chemistry from the
University of Maryland. He has been a director of a number of public and private companies involved in the healthcare industry.
The Board believes that Dr. Feldman’s over 40 years of operating, scientific and business experience in the medical/biotech
industry qualifies him for service on our board.
Elwood D. Howse, Jr. (1) (2) (3)
Elwood D. Howse, Jr., 76, has served as a director of the Company
since September 1987. In 1982, Mr. Howse founded Cable, Howse and Ragen, investment banking and stock brokerage firm, subsequently
known as Ragen MacKenzie. In 1977, Mr. Howse co-founded Cable & Howse Ventures, an early stage venture capital firm
focused on technology. In 1976, he served as Vice President, Corporate Finance, for Foster & Marshall, a northwest stock
brokerage firm. In 1974 he was the Chief Financial Officer of Seattle Stevedore Company and the Miller Produce Company.
Mr. Howse has served as a corporate director and advisor to various public, private and non-profit enterprises. He served
on the board of the National Venture Capital Association and is past President of the Stanford Business School Alumni Association.
He currently serves on the boards of directors of Formotus, Inc., BeneSol Corporation, Stella Therapeutics, Inc. and not-for-profit,
Junior Achievement of Washington. Mr. Howse holds a BS in Engineering from Stanford University and an MBA from Stanford
Graduate School of Business.
The Board believes Mr. Howse’s education and experience, particularly
Mr. Howse’s financial experience, which qualifies him to be designated as our financial expert on our Audit Committee, brings
important financial and business experience to the board and qualifies him to serve on our board.
******
|
(1)
|
Member of the Audit Committee
|
|
(2)
|
Member of the Compensation Committee
|
(3) Member of the Corporate Governance/Nominating Committee
The Audit Committee, which is a separately-designated standing committee
established in accordance with Section 3(a)(58)(A) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
consists of Mr. Howse (Chairman), and Mr. Fangmann. On March 18, 2016, Dr. Feldman replaced Mr. Fangmann.
In particular, all Audit Committee members possess the required
level of financial literacy, at least one member of the Audit Committee meets the current standard of requisite financial management
expertise and the Board of Directors has determined that Elwood D. Howse, Jr., the Chairman of the Audit Committee, is an “audit
committee financial expert” as defined in Item 407(d) of Regulation S-K of the Securities and Exchange Commission (the “SEC”).
Additionally, Mr. Howse and Mr. Fangmann are “independent directors”, as defined in Nasdaq Listing Rule 5605(a)(2).
Executive
Officers
The employment of Mr. Holliman and Dr. Steer was terminated effective
October 31, 2011. They continue to perform many of their previous duties and responsibilities under consulting agreements.
The following table sets forth information regarding our executive
officers and significant consultant:
Name
|
Age
|
Title
|
John M. Holliman, III
|
62
|
Executive Chairman and Principal Executive
Officer
|
Randolph C. Steer, MD, Ph.D.
|
66
|
Consultant
|
Les M. Taeger
|
65
|
Senior Vice President, Chief Financial Officer
and Principal Financial and Accounting Officer
|
John M. Holliman, III, became Executive Chairman and Principal Executive
Officer of the Company on April 5, 2006 and has served as a director of the Company since September 1987 and as Chairman of the
Board of Directors since August 1997. Since February 1993 he has been a general partner of entities, which are the general partners
of Valley Ventures, LP (formerly known as Arizona Growth Partners, LP), Valley Ventures II, LP, Valley Ventures III Annex, LP,
all of which are venture capital funds that invest principally in life science companies.
Randolph C. Steer, MD, Ph.D. served
as President of the Company from April 5, 2006 until October 31, 2011. Since then, Dr. Steer has provided
scientific, regulatory and clinical consulting services to the Company. Dr. Steer has been an independent pharmaceutical,
biotechnology and medical devices consultant since 1989, and has provided services to the Company since 2002. He has a broad
scientific, medical and business background, including extensive experience in pre-clinical, clinical and regulatory affairs,
having held key management positions in leading corporations and having served as an advisor to many companies in the United States
and abroad. Dr. Steer has also advised numerous venture capital firms, investment banks and independent investors on the
commercial development of drugs, biologics, diagnostics and medical devices. He has served as Associate Director of Medical
Affairs at Marion Laboratories; Medical Director at Ciba Consumer Pharmaceuticals (Ciba-Geigy Corporation); Vice President, Senior
Vice President and Member of the Executive Committee at Physicians World Communications Group; Chairman, President and Chief Executive
Officer of Advanced Therapeutics Communications International, a global drug regulatory group, and Chairman and Chief Executive
Officer of Vicus.com, Inc. He is a member of the Board of Trustees of the Mayo Clinic and the Board of Directors of Techne
Corporation and Vital Therapies, and was a member of the Board of Directors of BioCryst Pharmaceuticals from 1994 to 2009.
Dr. Steer received his MD degree from the Mayo Medical School and his Ph.D. from the University of Minnesota, where he also completed
a residency and subspecialty training in clinical and chemical pathology. He is a Fellow of the American College of
Clinical Pharmacology.
Les M. Taeger joined the Company as Senior Vice President and Chief
Financial Officer on January 16, 2006. Mr. Taeger most recently served as Chief Financial Officer of CardioTech International,
Inc. (currently AdvanSource Biomaterials Corporation) (“CardioTech”). CardioTech was a publicly-traded, medical device
company that developed, manufactured and sold advanced products for the treatment of cardiovascular disease. From September 2000
to February 2004, when Mr. Taeger became Chief Financial Officer of CardioTech, Mr. Taeger served as Chief Financial Officer of
Gish Biomedical, Inc. (“Gish”). Gish, which became a subsidiary of CardioTech pursuant to a merger transaction involving
the companies in April 2003, specialized in the manufacture and sale of products used in open-heart surgery, vascular access and
orthopedic surgery. Prior to his employment with CardioTech and Gish, Mr. Taeger was employed for over five years as Chief Financial
Officer of Cartwright Electronics, Inc., a division of Meggitt, PLC. Mr. Taeger is a Certified Public Accountant, with a Bachelor’s
degree in accounting.
Corporate
Governance and Code of ethics
The Company’s code of ethics applies to all of its employees
and has particular sections that apply only to its principal executive officer and senior financial officers. The Company has
posted the text of its code of ethics on its website (www.capstonethx.com), under the “Investors” section under the
link “Corporate Governance” “Code of Ethics”. In addition, the Company will promptly disclose on its website
(1) the nature of any amendment to its code of ethics that applies to its principal executive officer and senior financial officers,
and (2) the nature of any waiver, including an implicit waiver, from a provision of its code of ethics that is granted to one
of these specified officers, the name of such officer who is granted the waiver and the date of the waiver.
The full Board of Directors addresses all matters regarding corporate
governance (that is, the relationships of the Board, the stockholders and management in determining the direction and performance
of the Company) and the procedural rules regarding the operation of the Board itself. As such, the Board reviews all proposals
submitted by stockholders for action at the annual stockholders’ meeting.
Section
16(
a
) Beneficial Ownership Reporting Compliance
Under the securities laws of the United States, the Company’s
directors, its executive officers and any persons holding more than 10% of the Company’s Common Stock are required to report
their initial ownership of the Company’s Common Stock and any subsequent changes in that ownership to the SEC. Specific
due dates for these reports have been established, and the Company is required to disclose any failure to file by these dates.
The Company believes that all of these filing requirements were satisfied during the year ended December 31, 2015.
In making these disclosures, the Company has relied solely on written
representations of those persons it knows to be subject to the reporting requirements and copies of the reports that they have
filed with the SEC.
A list of directors, executive officers and persons holding more
than 10% of the Company’s Common Stock is included in Item 12 under the caption “Security Ownership of Certain Beneficial
Owners and Management and Related Stockholder Matters” in this Annual Report on Form 10-K.
Item 11. Executive Compensation
Compensation
of Directors
The following table sets forth compensation awarded to, earned by
or paid to the Company’s directors during the last fiscal year. Mr. John Holliman, III is not included in this table and
his compensation as a director is included in the Summary Compensation Table in the Executive Compensation section in this Annual
Report on Form 10-K.
Name
(a)
|
Fees Earned or Paid in Cash
($)
(b)
|
Stock
Awards
($)
(c)
|
Option
Awards
($)
(1)
(d)
|
Non-Equity Incentive Plan Compensation
($)
(e)
|
Nonqualified
Deferred
Compensation
Earnings
($)
(f)
|
All Other
Compensation
($)
(g)
|
Total
($)
(h)
|
Fredric J. Feldman, Ph.D.
Elwood D. Howse, Jr.
Eric W. Fangmann
|
24,000
24,000
24,000
|
|
18,000
18,000
18,000
|
-
-
-
|
-
-
-
|
-
-
-
|
42,000
42,000
42,000
|
|
(1)
|
Fair value of the grants at the date of the grants was determined
using the Black-Scholes model as described in Note 5 to the Financial Statements included
in this Annual Report on Form 10-K.
|
During the year ended December 31, 2015, the Company paid non-executive
directors Board Fees of $6,000 per quarter. All directors are eligible for a grant of non-qualified stock options pursuant to
the Company’s 2005 Equity Incentive Plan. The Company granted to each non-executive director (Fangmann, Feldman, Howse)
non-qualified options to acquire 50,000 shares at an exercise price of $0.22 per share on January 2, 2015 (fair value of $8,000);
10,000 shares at an exercise price of $0.17 per share on April 10, 2015 (fair value of $1,000), and 50,000 shares at an exercise
price of $0.25 on June 19, 2015 (fair value $9,000). These options vested immediately and were granted at the closing market price
on the date of grant. All options have been granted with ten-year terms.
Director Outstanding Equity Awards at Fiscal
Year-End
Name
|
Option
Awards
|
|
Number of Securities Underlying
Unexercised Options (#) Exercisable
|
Number of Securities Underlying
Unexercised Options (#) Unexercisable
|
Equity Incentive Plan Awards:
Number of Securities Underlying Unexercised Unearned Options (#)
|
Options
Exercise
Price ($)
|
Option
Expiration
Date
|
John M. Holliman, III
|
200,000
|
|
|
1.75
|
5/12/2016
|
|
50,000
|
|
|
1.02
|
2/21/2018
|
|
125,000
|
|
|
0.45
|
2/3/2019
|
|
100,000
|
|
|
0.82
|
2/4/2020
|
|
25,000
|
|
|
0.70
|
10/30/2018
|
|
65,000
|
|
|
0.17
|
5/18/2022
|
|
65,000
|
|
|
0.16
|
8/9/2022
|
|
51,000
|
|
|
0.21
|
2/28/2023
|
|
22,000
|
|
|
0.30
|
2/6/2024
|
|
50,000
|
|
|
0.17
|
4/10/2025
|
*
|
150,000
|
50,000
|
|
0.25
|
6/19/2025
|
|
100,000
|
|
|
0.12
|
12/18/2025
|
Eric W. Fangmann
|
50,000
|
|
|
0.24
|
6/12/2024
|
Various directors:
|
|
|
|
|
|
(1) (2) (3)
|
10,000
|
|
|
4.90
|
1/2/2016
|
(1) (2) (3)
|
25,000
|
|
|
1.75
|
5/12/2016
|
(1) (2) (3)
|
10,000
|
|
|
1.43
|
1/1/2017
|
(1) (2) (3)
|
10,000
|
|
|
1.35
|
1/1/2018
|
(1) (3)
|
25,000
|
|
|
0.70
|
10/30/2018
|
(1) (2) (3)
|
10,000
|
|
|
0.42
|
1/1/2019
|
(1) (2) (3)
|
10,000
|
|
|
0.72
|
1/1/2020
|
(1)(2)(3)
|
10,000
|
|
|
0.58
|
1/1/2021
|
(1) (2) (3)
|
10,000
|
|
|
0.26
|
1/1/2022
|
(1) (2)
|
35,000
|
|
|
0.17
|
5/18/2022
|
(1) (2)
|
42,500
|
|
|
0.16
|
8/9/2022
|
(1) (2) (3)
|
10,000
|
|
|
0.17
|
1/1/2023
|
(1) (3)
|
27,000
|
|
|
0.21
|
2/28/2023
|
(1)(2)(3)
|
10,000
|
|
|
0.26
|
1/1/2024
|
(1)(3)
|
12,000
|
|
|
0.30
|
2/6/2024
|
(1)(2)(3)(4)
|
50,000
|
|
|
0.22
|
1/2/2025
|
(1)(3)(4)
|
10,000
|
|
|
0.17
|
4/10/2025
|
(1)(2)(3)(4)
|
50,000
|
|
|
0.25
|
6/19/2025
|
Feldman, Fred (1)
|
|
|
|
|
|
Holliman, John (2)
|
|
|
|
|
|
Howse, Elwood (3)
|
* Vest in 2016
|
|
|
|
|
Fangmann, Eric (4)
|
All other directors options were fully vested
on 12/31/2015
|
|
EXECUTIVE COMPENSATION
The Compensation Committee’s Conclusion
The Compensation Committee, at its meeting held at the beginning
of each fiscal year, formulates its recommendations regarding which compensation components will be adjusted for the upcoming
year and what the performance bonus for the prior year will be.
Board Approval
At the first Compensation Committee meeting of the year, the Compensation
Committee reviews the Executive Chairman’s and other executive officers’ compensation and bonuses and presents its
recommendations to the Board of Directors. The final total compensation package decision regarding the Executive Chairman is made
by the Independent Directors in an Executive Session without the Executive Chairman or other members of management present, and
the final decisions on other executives’ total compensation packages are made by the full Board of Directors.
The following discussion is provided to facilitate stockholder understanding
of the named executive officer compensation information included in this Annual Report on Form 10-K.
Officer and Key Consultant Compensation
On October 13, 2011, the Company’s Board of Directors (the
“Board”) adopted a plan to preserve cash during ongoing partnering efforts. Included in the actions taken was the
termination of the employment of John M. Holliman, III, Executive Chairman and Randolph C. Steer, MD, Ph.D., President. These
individuals have continued as consultants, rather than as employees, at consulting rates which would equate to approximately $100,000
per year for Mr. Holliman and $120,000 per year for Dr. Steer. As employees, their base compensation had been $200,000 for Mr.
Holliman and $325,000 for Dr. Steer. Les M. Taeger, Chief Financial Officer and Senior Vice President has continued as an employee,
but his base compensation was reduced from $242,000 per year to $120,000 (increased to $135,000 for 2014) per year. All of these
officers had also been eligible for an annual bonus based on individual and Company performance goals of up to 40% of their base
compensation. The Board’s actions included cancellation of the Company’s bonus plan. The vested outstanding stock
options held by each executive will continue to be exercisable while such executive is serving as a consultant to the Company.
In 2015, to conserve the cash resources of the Company, Mr. Holliman
received consulting cash compensation of $54,000 and Dr. Steer received consulting cash compensation of $63,000. In 2016, consulting
cash compensation for Mr. Holliman and Dr. Steer will be at a rate lower than 2015, until additional funding is received by the
Company. Additionally, all other employees and consultants cash compensation has been reduce in 2016, until additional funding
is received by the Company.
Equity-Based Compensation
We provide a certain level of cash compensation to each executive
as both a short-term reward and to focus executive performance on short-term goals that are part of our long-term strategies.
Additionally, we use a combination of stock option grants and common stock awards to generate a commitment to, and a long-term
investment in, our Company. Grants and awards were determined based on the position and competitive factors, as well as substantial
compensation reductions effective October 31, 2011.
Stock Option Grants
In 2015, the Company granted options to employees to purchase 880,000
shares of the Company’s Common Stock with the exercise price determined by the closing market price on the date of grant
($0.12 to $0.25) and an aggregate grant date fair value of $137,000. These grants included grants to the named executives (Holliman
450,000 shares, Steer 190,000 shares and Taeger 190,000 shares).
Common Stock Awards
The Company did not grant any common stock awards in 2015.
Fringe Benefits, Perquisites and Retirement Benefits.
Our executive employee participates in group health, dental, life,
and disability programs on the same basis as other employees. No perquisites are provided to executives that in aggregate exceed
$10,000 per year.
Joint Venture Bonus Plan
On August 9, 2012, our Board approved a performance-based incentive
compensation plan (the “Plan”) for our executive and consultants who were primarily responsible for identifying the
investment opportunity for the development of Apo E mimetic peptide AEM-28 and its analogs, a class of Cardiovascular drugs targeting
indications related to lowering blood cholesterol levels, completing the formation of the joint venture, LipimetiX Development,
LLC (the “JV”), and who will participate in the management of the JV.
The Plan provides for a bonus pool, shared 40% by Mr. Holliman,
40% by Dr. Steer and 20% by Mr. Taeger, of 2.5% of the cash or in-kind distributions from the JV to the Company after the Company
has received the return of its initial $6,000,000 investment. The individuals’ interest in the bonus pool vested 50% upon
Board approval of the Plan (August 9, 2012) and vested 50% upon the presentation by the JV to its Members of quantitative/qualitative
safety and efficacy results from all protocol-designated endpoints of the AEM-28 Phase 1b/2a clinical trial. The bonuses are fully
vested at December 31, 2015; however, no amounts have been earned as of December 31, 2015.
Summary
Compensation Table
The following table sets forth, with respect to the years ended
December 31, 2015, 2014 and 2013, compensation awarded to, earned by or paid to the Company’s principal executive officer,
principal financial officer and key consultant who were serving at the end of the last completed fiscal year (the “named
executive officers”).
Name
|
Year
|
Salary
|
Bonus
|
Stock
Awards
|
Option
Awards (1)
|
Non-Equity
Incentive Plan
Compensation
|
Nonqualified
Deferred Compensation Earnings
|
All
Other
Compensation
|
Total
|
|
|
($)
|
($)
|
($)
|
($)
|
($)
|
($)
|
($)
|
($)
|
|
|
|
|
|
|
|
|
|
|
(a)
|
(b)
|
(c)
|
(d)
|
(e)
|
(f)
|
(g)
|
(h)
|
(i)
|
(j)
|
|
|
|
|
|
|
|
|
|
|
John M. Holliman, III
|
2015
|
54,000
|
-
|
-
|
67,000
|
-
|
-
|
16,000
|
137,000
|
Executive Chairman
|
|
|
|
|
|
|
|
|
|
(Principal Executive
|
2014
|
100,000
|
-
|
-
|
7,000
|
-
|
-
|
31,000(1)
|
138,000
|
Officer)
|
|
|
|
|
|
|
|
|
|
|
2013
|
100,000
|
-
|
-
|
7,000
|
-
|
-
|
41,000(1)
|
148,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Randolph C. Steer, MD, Ph.D.,
|
2015
|
63,000
|
-
|
-
|
31,000
|
-
|
-
|
-
|
94,000
|
Consultant
|
|
|
|
|
|
|
|
|
|
(former President)
|
2014
|
120,000
|
15,000
|
-
|
5,000
|
-
|
-
|
-
|
140,000
|
|
|
|
|
|
|
|
|
|
|
|
2013
|
120,000
|
-
|
-
|
9,000
|
-
|
-
|
-
|
129,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Les M. Taeger
|
2015
|
135,000
|
-
|
-
|
31,000
|
-
|
-
|
-
|
166,000
|
Chief Financial Officer
|
|
|
|
|
|
|
|
|
|
(Principal Financial Officer)
|
2014
|
135,000
|
-
|
-
|
3,000
|
-
|
-
|
-
|
138,000
|
|
|
|
|
|
|
|
|
|
|
|
2013
|
120,000
|
-
|
-
|
6,000
|
-
|
-
|
-
|
126,000
|
|
1.
|
Mr. Holliman is a member of the Board of Directors and as
a director, received compensation of $16,000, $31,000 and $41,000, in cash, in 2015,
2014 and 2013, respectively. Mr. Holliman received total director’s compensation
(Board fees and option grants) of $33,000, $38,000 and $48,000 in 2015, 2014 and 2013,
respectively, as more fully described in the Compensation of Directors section of this
Annual Report on Form 10-K. Mr. Holliman in 2015, received non-director grants of options
to purchase shares of the Company’s Common Stock of 50,000 shares on April 10,
2015, 200,000 shares on June 19, 2015 and 100,000 shares on December 18, 2015 (aggregate
fair value of $50,000). Fair value of the grants at the date of the grants was determined
using the Black-Scholes model as described, for 2015, in Note 5 to the Financial Statements
included in this Annual Report on Form 10-K, for 2014, in Note 5 to our Annual Report
on form 10-K filed with the Securities and Exchange Commission on March 16, 2015 and
for 2013, in Note 5 to the Annual Report on form 10-K filed with the Securities and Exchange
Commission on March 27, 2014.
|
Option
GRANTS / STOCK AWARDS
The following table sets forth information about stock option grants
and stock awards during the last completed fiscal year to the executive officers named in the Summary Compensation Table.
Grants of Plan-based Awards
Name
|
Grant
|
All
Other Stock
Awards:
Number of
Shares of
Stock
or Units
#
|
All
Other Option
Awards:
Number of
Securities
Underlying
Options
#
|
Exercise
or Base
Price of Option
Awards
($/Share)
|
Grant
Date Fair
Value of Stock
and Option Awards (1)
($)
|
(a)
|
(b)
|
(i)
|
(j)
|
(k)
|
(l)
|
|
|
|
|
|
|
John M. Holliman, III
|
1/2/2015
|
-
|
50,000
|
0.22
|
8,000
|
Executive Chairman
|
4/10/2015
|
-
|
50,000
|
0.17
|
6,000
|
|
6/19/2015
|
-
|
250,000
|
0.25
|
44,000
|
|
12/18/2015
|
-
|
100,000
|
0.12
|
9,000
|
|
|
|
|
|
|
Randolph C. Steer, MD, Ph.D.
|
1/2/2015
|
-
|
50,000
|
0.22
|
8,000
|
Consultant
|
4/10/2015
|
-
|
40,000
|
0.17
|
5,000
|
|
6/19/2015
|
-
|
100,000
|
0.25
|
18,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Les M. Taeger
|
1/2/2015
|
-
|
50,000
|
0.22
|
8,000
|
Chief Financial Officer
|
4/10/2015
|
-
|
40000
|
0.17
|
5,000
|
|
6/19/2015
|
-
|
100000
|
0.25
|
18,000
|
(1) Fair value of the grants at the date of
the grants was determined using the Black-Scholes model as described in Note 5 to the Financial Statements included in this Annual
Report on Form 10-K.
Outstanding Equity Awards
at Fiscal Year END
Name
|
Option Awards
|
|
Number of Securities Underlying Unexercised Options (#) Exercisable
|
Number of Securities Underlying Unexercised Options (#) Unexercisable
|
Option
Exercise Price
($)
|
Option
Expiration Date
|
(a)
|
(b)
|
(c)
|
(e)
|
(f)
|
John M. Holliman
|
10,000
|
-
|
4.90
|
1/2/2016
|
|
25,000
|
-
|
1.75
|
5/12/2016
|
|
200,000
|
-
|
1.75
|
5/12/2016
|
|
10,000
|
-
|
1.43
|
12/31/2017
|
|
10,000
|
-
|
1.35
|
12/31/2018
|
|
50,000
|
-
|
1.02
|
2/21/2018
|
|
25,000
|
-
|
0.70
|
10/30/2018
|
|
10,000
|
-
|
0.42
|
1/1/2019
|
|
125,000
|
-
|
0.45
|
2/3/2019
|
|
10,000
|
-
|
0.72
|
1/1/2020
|
|
100,000
|
|
0.82
|
2/4/2020
|
|
10,000
|
-
|
0.58
|
1/1/2021
|
|
10,000
|
-
|
0.26
|
1/1/2022
|
|
65,000
|
-
|
0.17
|
5/18/2022
|
|
65,000
|
-
|
0.16
|
8/9/2022
|
|
10,000
|
-
|
0.17
|
1/1/2023
|
|
51,000
|
-
|
0.21
|
2/28/2023
|
|
10,000
|
-
|
0.26
|
1/1/2024
|
|
22,000
|
-
|
0.30
|
2/6/2024
|
|
50,000
|
-
|
0.22
|
1/2/2025
|
|
50,000
|
-
|
0.17
|
4/10/2025
|
*
|
200,000
|
50,000
|
0.25
|
6/19/2025
|
|
100,000
|
-
|
0.12
|
12/18/2025
|
Randolph C. Steer, MD, Ph.D.
|
200,000
|
-
|
1.75
|
5/12/2016
|
|
50,000
|
-
|
1.53
|
5/21/2017
|
|
50,000
|
-
|
1.02
|
2/21/2018
|
|
75,000
|
-
|
0.45
|
2/3/2019
|
|
50,000
|
-
|
0.82
|
2/4/2020
|
|
50,000
|
-
|
0.67
|
1/17/2021
|
|
65,000
|
-
|
0.17
|
5/18/2022
|
|
65,000
|
|
0.16
|
8/9/2022
|
|
51,000
|
-
|
0.21
|
2/28/2023
|
|
10,000
|
-
|
0.35
|
10/25/2023
|
|
22,000
|
-
|
0.30
|
2/6/2024
|
*
|
47,917
|
2,083
|
0.22
|
1/2/2025
|
*
|
33,333
|
6,667
|
0.17
|
4/10/2025
|
|
100,000
|
-
|
0.25
|
6/19/2025
|
Outstanding Equity Awards
at Fiscal Year END
|
|
|
|
|
Name
|
Option Awards
|
|
Number of Securities Underlying Unexercised Options (#) Exercisable
|
Number of Securities Underlying Unexercised Options (#) Unexercisable
|
Option Exercise Price
($)
|
Option Expiration Date
|
(a)
|
(b)
|
(c)
|
(e)
|
(f)
|
|
|
|
|
|
Les M. Taeger
|
150,000
|
-
|
5.15
|
1/16/2016
|
|
150,000
|
-
|
1.70
|
6/2/2016
|
|
14,706
|
-
|
1.02
|
2/21/2018
|
|
50,000
|
-
|
0.45
|
2/3/2019
|
|
35,000
|
-
|
0.82
|
2/4/2020
|
|
25,000
|
-
|
0.67
|
1/17/2021
|
|
45,000
|
-
|
0.17
|
5/18/2022
|
|
45,000
|
-
|
0.16
|
8/9/2022
|
|
29,000
|
-
|
0.21
|
2/28/2023
|
|
10,000
|
-
|
0.35
|
10/25/2023
|
|
15,000
|
-
|
0.30
|
2/6/2024
|
*
|
47,917
|
2,083
|
0.22
|
1/2/2025
|
*
|
33,333
|
6,667
|
0.17
|
4/10/2025
|
*
|
50,000
|
50,000
|
0.25
|
6/19/2025
|
|
|
|
|
|
*Will Vest in 2016
|
|
|
|
|
Employment Contracts,
Termination of Employment, and
Change-in-Control Arrangements
Effective April 5, 2006, Mr. John M. Holliman, III, became Executive
Chairman and Principal Executive Officer. On May 12, 2006, the Company entered into an agreement to compensate Mr. Holliman for
his services as the Company’s Executive Chairman and principal executive officer (the “Holliman Agreement”).
Effective October 31, 2011, the employment of Mr. Holliman was terminated,
which resulted in the acceleration of the vesting of the options to purchase shares of the Company’s common stock held by
Mr. Holliman, so that his options became exercisable, and payment of his severance benefit. Subsequent to October 31, 2011, Mr.
Holliman has continued his role as Executive Chairman under a consulting agreement, which provides for compensation at an annual
rate of $100,000. Mr. Holliman did not receive a bonus in 2015.
Effective April 5, 2006, Randolph C. Steer, MD, Ph.D., became President
of the Company. Dr. Steer has performed services for the Company since 2002. On May 12, 2006, the Company also entered into an
agreement with Randolph C. Steer, MD, Ph.D., to compensate Dr. Steer for his services as the Company’s President and Chief
Operating Officer (the “Steer Agreement”).
Effective October 31, 2011, the employment of Dr. Steer was terminated
which resulted in the acceleration of the vesting of the options to purchase shares of the Company’s common stock held by
Dr. Steer, so that his options became exercisable, and payment of his severance benefits. Subsequent to October 31, 2011, Dr.
Steer has continued to provide services under a consulting agreement, which provides for compensation at an annual rate of $120,000.
Dr. Steer did not receive a bonus in 2015.
On January 10, 2006, the Company entered into an employment
agreement with Les M. Taeger, dated as of January 10, 2006, effective as of January 16, 2006 (the “Taeger Employment
Agreement”), pursuant to which Mr. Taeger serves as the Company’s Senior Vice President / Chief Financial Officer.
Under the Taeger Employment Agreement, Mr. Taeger may be terminated at any time, with or without cause, at the option of
either the Company or Mr. Taeger. Mr. Taeger receives medical, dental and other fringe benefits generally granted to
the Company’s senior management.
Effective October 31, 2011, Mr. Taeger’s annual base salary
was reduced to $120,000 and the Company’s bonus plan was terminated. Mr. Taeger did not receive a bonus in 2015. Mr. Taeger’s
salary for 2015 was $135,000.
In 2015, to conserve the cash resources of the Company, Mr. Holliman
received consulting cash compensation of $54,000 and Dr. Steer received consulting cash compensation of $63,000. In 2016, consulting
cash compensation for Mr. Holliman and Dr. Steer will be at a rate lower than 2015, until additional funding is received by the
Company. Additionally, all other employees and consultants cash compensation has been reduce in 2016, until additional funding
is received by the Company.
Under the Company’s stock option plans, upon the occurrence
of a merger in which the Company is not the surviving entity, a sale of substantially all of the assets of the Company, an acquisition
by a third party of 100% of the Company’s outstanding equity securities or a similar reorganization of the Company, 75%
of all unvested options will vest, with the balance vesting equally over 12 months or according to the individual’s vesting
schedule, whichever is earlier. If the option holder loses his position with the Company as a result of the merger or sale, 100%
of his options will immediately vest. Additionally, the Company’s 2005 and 2015 Equity Incentive Plans provide that, upon
a merger, consolidation or reorganization with another corporation in which the Company is not the surviving corporation, outstanding
options shall be substituted on an equitable basis for options for appropriate shares of the surviving corporation, or optionees
shall receive cash in exchange for cancellation of outstanding options.
At December 31, 2015, unvested options held by named executive officers
had no intrinsic value and accelerated vesting clauses, if triggered at December 31, 2015, would have provided no additional compensation
to the named executive officers.
Item 12. Security
Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Security Ownership of Certain Beneficial
Owners and Management
The following table sets forth information regarding the beneficial
ownership of the Company’s Common Stock at March 15, 2016 with respect to (i) each person known to the Company to own beneficially
more than five percent of the outstanding shares of the Company’s Common Stock, (ii) each director of the Company, (iii)
each of the named executive officers and (iv) all directors and executive officers of the Company as a group. At March 15, 2016
there were 40,885,411 shares of the Company’s Common Stock outstanding.
|
|
Common Stock
|
|
|
Beneficially Owned (1)
|
Beneficial Owner
|
|
Number
|
|
Percent of Class
|
Eric W. Fangmann (2)
|
|
|
210,000
|
|
|
|
less
than 1%
|
|
Fredric J. Feldman (3)
|
|
|
607,064
|
|
|
|
1.5
|
|
John M. Holliman, III (4)
|
|
|
1,595,170
|
|
|
|
3.8
|
|
Elwood D. Howse, Jr. (5)
|
|
|
604,203
|
|
|
|
1.5
|
|
Randolph C. Steer 65)
|
|
|
723,298
|
|
|
|
1.7
|
|
Les M. Taeger (7)
|
|
|
653,280
|
|
|
|
1.6
|
|
BVF Group (8)
|
|
|
7,755,688
|
|
|
|
19.0
|
|
Lloyd Miller, III (9)
|
|
|
7,926,389
|
|
|
|
19.4
|
|
All directors and executive officers as a group (10)
|
|
|
4,393,015
|
|
|
|
9.9
|
|
|
(1)
|
Beneficial ownership is determined in accordance with the rules
of the Securities and Exchange Commission (“SEC”) and generally includes
voting or investment power with respect to securities. In accordance with SEC rules,
shares, which may be acquired upon exercise of stock options which are currently exercisable
or which become exercisable within 60 days of the date of the table, are deemed beneficially
owned by the optionee. Except as indicated by footnote, and subject to community property
laws where applicable, the persons or entities named in the table above have sole voting
and investment power with respect to all shares of Common Stock shown as beneficially
owned by them.
|
|
(2)
|
Includes 210,000 shares Mr. Fangmann has a right to acquire
upon exercise of stock options.
|
|
(3)
|
Includes 381,500 shares Dr. Feldman has a right to acquire
upon exercise of stock options. Voting and investment power shared with spouse.
|
|
(4)
|
Includes 1,083000 shares Mr. Holliman has a right to acquire
upon exercise of stock options.
|
|
(5)
|
Includes 381,500 shares Mr. Howse has a right to acquire upon
exercise of stock options.
|
|
(6)
|
Includes 678,000 shares Dr. Steer has a right to acquire upon
exercise of stock options.
|
|
(7)
|
Includes 608,706 shares Mr. Taeger has a right to acquire upon
exercise of stock options.
|
|
(8)
|
BVF Group (Biotechnology Value Fund, L.P., Biotechnology Value
Fund II, L.P. BVF Investments, L.L.C., Investment 10, L.L.C., BVF Partners, L.P., BVF
Inc.) is not a related party or otherwise affiliated with the Company, its directors
or officers, and the principal business office of the Reporting Persons comprising the
Group is located at 900 North Michigan Avenue, Suite 1100, Chicago, IL 60611.
|
|
(9)
|
Lloyd Miller, III, is not a related party or otherwise affiliated
with the Company, its directors or officers, except that Lloyd Miller, III, recommended
Eric W. Fangmann to be a Company Board of Director member and Eric W. Fangmann is the
Chief Financial Officer of various business entities associated with Mr. Miller, and
the principal business office of the Reporting Person is located at 222 Lakeview Avenue,
Suite 160-365, West Palm Beach, Florida 33401
|
|
(10)
|
Includes 3,342,706 shares directors and executive officers
have a right to acquire upon exercise of stock options.
|
The address of each of the listed stockholders, unless noted otherwise, is in care of
Capstone Therapeutics Corp., 1275 West Washington Street, Suite 104, Tempe, AZ 85281.
EQUITY COMPENSATION PLANS
The following provides tabular disclosure of the number of securities
to be issued upon the exercise of outstanding options, the weighted average exercise price of outstanding options, and the number
of securities remaining available for future issuance under equity compensation plans as of December 31, 2015, aggregated into
two categories - plans that have been approved by stockholders and plans that have not. See Note 5 to the Financial Statements
included in this Annual Report on Form 10-K for additional information on our equity compensation plans.
Plan Category:
|
|
Number of
securities to
be issued upon exercise
of outstanding options,
warrants and rights
(c)
|
|
Weighted average
exercise
price of
outstanding options,
warrants and rights
(b)
|
|
Number of securities remaining
available for future issuance
under equity compensation plans
(excluding securities reflected in
column (a)
(c)
|
Equity Compensation Plans approved by Security Holders
|
|
|
4,162,706
|
|
|
$
|
0.81
|
|
|
|
280,000
|
|
Equity Compensation Plans not approved by Security Holders
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Total
|
|
|
4,162,706
|
|
|
$
|
0.81
|
|
|
|
280,000
|
|
Item 13. Certain Relationships and Related Transactions,
and Director Independence
In 2006 Mr. Holliman became Executive Chairman and Principal Executive
Officer of the Company and is no longer an independent director under Nasdaq Listing Rule 5605(a)(2). Currently, the Board of
Directors is composed of three outside directors who are independent directors under Nasdaq Listing Rule 5605(a)(2) and one director
who is not an independent director under Nasdaq Listing Rule 5605(a)(2).
CERTAIN RELATIONSHIPS AND
RELATED TRANSACTIONS
The Board of Directors reviews transactions with related parties,
but has no formal policies in place with respect to such reviews or the approval of such transactions. During 2015 there were
no reported related party transactions with directors, executive officers or other related parties, which might have required
disclosure under SEC rules or which were otherwise material to the Company.
The Company has entered into indemnity agreements with all of its
directors and officers for the indemnification of and advancing of expenses to such persons to the fullest extent permitted by
law.
Item 14. Principal Accountant Fees and Services
The following table sets forth the aggregate fees billed to the
Company for the years ended December 31, 2015 and December 31, 2014 by our principal accounting firm Moss Adams LLP. We have not
engaged an independent public accountant to audit our fiscal year ended December 31, 2015 financial statements.
Type of Fee
|
|
Amount
|
|
|
2015
|
|
2014
|
Audit Fees (1)
|
|
$
|
86,000
|
|
|
$
|
99,000
|
|
Audit-Related Fees (2)
|
|
|
22,000
|
|
|
|
4,000
|
|
Total Audit and Audit-Related Fees
|
|
|
108,000
|
|
|
|
103,000
|
|
Tax Fees (3)
|
|
|
-
|
|
|
|
-
|
|
All Other Fees (4)
|
|
|
-
|
|
|
|
-
|
|
Total Fees
|
|
$
|
108,000
|
|
|
$
|
103,000
|
|
|
(1)
|
Audit fees include fees for services rendered in connection
with the audits of the Company’s financial statements, and reviews of the financial
statements included in the Company’s quarterly reports on Form 10-Q during the
applicable fiscal year.
|
|
(2)
|
Audit-related fees would include fees for services rendered
for matters such as a business combination, sales of shares of the Company’s common
stock, and responses to accounting and reporting-related matters.
|
|
(3)
|
Tax fees would include fees for services rendered for tax
compliance, preparation of original and amended tax returns, claims for refunds and other
tax services.
|
|
(4)
|
Our principal accounting firms did not perform nor bill the
Company for any other services during the fiscal years ended December 31, 2015 and 2014
that are appropriately classified as “All Other Fees.”
|
The Audit Committee has concluded that the services provided by
the principal accounting firm that were not related to the audit of the Company’s financial statements were at all times
compatible with maintaining that firm’s independence.
Consistent with the rules of the Securities and Exchange Commission
regarding auditor independence, the Audit Committee has responsibility for appointing, setting compensation for, and overseeing
the work of, the independent auditor. In recognition of this responsibility, the Audit Committee has included in its charter the
responsibility to pre-approve “all auditing services and permitted non-auditing services proposed to be performed by the
independent auditor, subject to the de minimis exceptions for non-audit services that were not recognized as non-audit services
at the time of engagement and which are subsequently approved by the committee prior to completion of the audit.” No fees
were paid to the independent auditor pursuant to the “de minimis” exception to the foregoing pre-approval policy in
2015.
NOTES TO FINANCIAL STATEMENTS
|
1.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
Overview of the Business
Capstone Therapeutics Corp. is a biotechnology company committed
to developing a pipeline of novel peptides and other molecules aimed at helping patients with under-served medical conditions.
Previously, we were focused on the development and commercialization of two product platforms: AZX100 and Chrysalin (TP508). Since
March 2012, we no longer have any interest in or rights to Chrysalin. In 2012 we wound down internal research operations, ceased
clinical development of AZX100 in dermal scarring, formerly our principal drug candidate, and moved to a more virtual operating
model. In 2014, we terminated the License Agreement for AZX100 intellectual property and returned all interest in and rights to
the AZX100 intellectual property to the Licensor (AzTE).
On August 3, 2012, we entered into a joint venture, LipimetiX Development,
LLC, (Now LipimetiX Development, INC.) (the “JV”) to develop Apo E mimetic peptide molecule AEM-28 and its analogs.
The JV has a development plan to pursue regulatory approval of AEM-28, or an analog, as treatment for Homozygous Familial Hypercholesterolemia
(granted Orphan Drug Designation by FDA in 2012), Acute Hypertriglyceridemic Pancreatitis (“AP”), diabetic dyslipidemia,
and other hyperlipidemic indications. The initial development plan extended through Phase 1a and 1b/2a clinical trials and was
completed in the fourth quarter of 2014. The clinical trials had a safety primary endpoint and an efficacy endpoint targeting
reduction of cholesterol and triglycerides.
In early 2014, the JV received allowance from regulatory authorities
in Australia permitting the JV to proceed with the planned clinical trials. The Phase 1a clinical trial commenced in Australia
in April 2014 and the Phase 1b/2a clinical trial commenced in Australia in June 2014. The clinical trials for AEM-28 are randomized,
double-blinded, placebo-controlled studies to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of six
escalating single doses (Phase 1a in healthy patients with elevated cholesterol) and multiple ascending doses of the three highest
doses from Phase 1a (Phase 1b/2a in patients with Hypercholesterolemia and healthy subjects with elevated cholesterol and high
Body Mass Index). The Phase 1a clinical trial consisted of 36 patients and the Phase 1b/2a consisted of 15 patients. Both clinical
trials were completed in 2014 and the Medical Safety Committee, reviewing all safety-related aspects of the clinical trials, observed
a generally acceptable safety profile. As first-in-man studies, the primary endpoint was safety; yet efficacy measurements analyzing
pharmacodynamics yielded statistical significance in the pooled dataset favoring AEM-28 versus placebo in multiple lipid biomarker
endpoints.
Concurrent with the development activities for AEM-28, the JV has
performed limited pre-clinical studies that have identified analogs of AEM-28, including one referred to as AEM-28-14, that have
the potential of increased efficacy, higher human dose toleration and an extended composition of matter patent life. The JV has
a development plan to pursue regulatory approval and commercialization of AEM-28, or one or more of its analogs, as treatment
in orphan (rare disease) indications, including AP and HoFH, and potentially in diabetic dyslipidemia, acute coronary syndrome,
peripheral artery disease and metabolic syndrome. HoFH has been designated by the FDA as an orphan indication. We believe that
AP may also qualify for orphan indication designation.
The JV and Company are exploring fundraising, partnering or licensing
to obtain additional funding to continue development activities of AEM-28 and its analogs, including AEM-28-14, and operations.
The JV and the Company do not have sufficient funding at this time
to continue additional material development activities of AEM-28 and its analogs, or operations. The JV may conduct future clinical
trials in Australia, the USA, and other regulatory jurisdictions if regulatory approvals, additional funding, and other conditions
permit. The JV may also fund research or studies to investigate AEM-28-14 for treatment of diabetic dyslipidemia, acute coronary
syndrome and other indications.
The Company, funding permitting, intends to continue limiting its
internal operations to a virtual operating model while monitoring and participating in the management of JV’s AEM-28 and
its analogs, development activities.
Description of Current Peptide Drug Candidates.
Chimeric Apo E Mimetic Peptide Molecule – AEM-28 and its
analogs
Apolipoprotein E is a 299 amino acid protein that plays an important
role in lipoprotein metabolism. AEM-28 is a 28 amino acid mimetic of Apo E and AEM-28 and its analogs, including AEM-28-14 is
a 28 amino acid mimetic of Apo E (with an aminohexanoic acid group and a phospholipid), and both contain a domain that anchors
into a lipoprotein surface while also providing the Apo E receptor binding domain, which allows clearance through the heparan
sulfate proteoglycan (HSPG) receptors (Syndecan-1) in the liver. AEM-28 and its analogs, including AEM-28-14, as Apo E mimetics,
have the potential to restore the ability of these atherogenic lipoproteins to be cleared from the plasma, completing the reverse
cholesterol transport pathway, and thereby reducing cardiovascular risk. This is an important mechanism of action for AEM-28 and
its analogs, including AEM-28-14. For patients that lack LDL receptors (Homozygous Familial Hypercholesterolemia-HoFH), have acute
pancreatitis, or have hypercholesterolemia, AEM-28 and its analogs may provide a therapeutic solution. Our joint venture has an
Exclusive License Agreement with the University of Alabama at Birmingham Research Foundation for AEM-28 and certain of its analogs.
Company History
Prior to November 26, 2003, we developed, manufactured and marketed
proprietary, technologically advanced orthopedic products designed to promote the healing of musculoskeletal bone and tissue,
with particular emphasis on fracture healing and spine repair. Our product lines, which included bone growth stimulation and fracture
fixation devices, are referred to as our “Bone Device Business.” In November 2003, we sold our Bone Device Business.
In August 2004, we purchased substantially all of the assets and
intellectual property of Chrysalis Biotechnology, Inc., including its exclusive worldwide license for Chrysalin, a peptide, for
all medical indications. Subsequently, our efforts were focused on research and development of Chrysalin with the goal of commercializing
our products in fresh fracture healing. (In March 2012, we returned all rights to the Chrysalin intellectual property and no longer
have any interest in, or rights to Chrysalin.)
In February 2006, we purchased certain assets and assumed certain
liabilities of AzERx, Inc. Under the terms of the transaction, we acquired an exclusive license for the core intellectual property
relating to AZX100, an anti-fibrotic peptide. In 2014, we terminated the License Agreement with AzTE (Licensor) for the core intellectual
property relating to AZX100 and returned all interest in and rights to the AZX100 intellectual property to the Licensor.
On August 3, 2012, we entered into a joint venture (see Note 9 below),
to develop Chimeric Apo E mimetic peptide molecule AEM-28 and its analogs.
Our development activities represent a single operating segment
as they shared the same product development path and utilized the same Company resources. As a result, we determined that it is
appropriate to reflect our operations as one reportable segment.
OrthoLogic Corp. commenced doing business under the trade name of
Capstone Therapeutics on October 1, 2008, and we formally changed our name from OrthoLogic Corp. to Capstone Therapeutics Corp.
on May 21, 2010.
In these notes, references to “we”, “our”,
“us”, the “Company”, “Capstone Therapeutics”, “Capstone”, and “OrthoLogic”
refer to Capstone Therapeutics Corp. References to our joint venture or “JV”, refer to LipimetiX Development, Inc.
(formerly LipimetiX Development, LLC).
Basis of presentation and Management’s Plans.
The accompanying
financials statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization
of assets and satisfaction of liabilities in the normal course of business.
Management has determined that the Company will require additional
capital above its current cash and working capital balances to further develop AEM-28 and its analogs or continue operations.
Accordingly, the Company has significantly reduced its development activities. The Company’s corporate strategy is to raise
funds by possibly engaging in a strategic/merger transaction, or conducting a private or public offering of debt or equity securities
for capital. These financial statements do not include any adjustments that might result from the outcome of this uncertainty
of corporate strategy.
Use of estimates.
The preparation of financial statements
in accordance with accounting principles generally accepted in the United States of America requires that management make a number
of assumptions and estimates that affect the reported amounts of assets, liabilities, and expenses in our financial statements
and accompanying notes. Management bases its estimates on historical experience and various other assumptions believed to be reasonable.
Although these estimates are based on management’s assumptions regarding current events and actions that may impact the
Company in the future, actual results may differ from these estimates and assumptions.
Our significant estimates include income taxes, contingencies, accounting
for stock-based compensation, accounting for the Australian refundable research and development tax credit, and accounting for
the formation and consolidation of JV.
Fair value measurements.
We determine the fair value measurements
of our applicable assets and liabilities based on a three-tier fair value hierarchy, which prioritizes the inputs used in measuring
fair value. These tiers include: Level 1, defined as observable inputs such as quoted market prices in active markets; Level 2,
defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined
as unobservable inputs for which little or no market data exists, therefore requiring an entity to develop its own assumptions.
Cash and cash equivalents.
Cash and cash equivalents include
money market accounts.
Furniture and equipment
. Furniture and equipment are stated
at cost. Depreciation is calculated on a straight-line basis over the estimated useful lives of the various assets, which range
from three to seven years. Leasehold improvements are amortized over the life of the asset or the period of the respective lease
using the straight-line method, whichever is the shortest.
Research and development expenses
.
Research and development represents costs incurred for research and development activities, including costs incurred to fund the
pre-clinical and clinical testing of our product candidates. Research and development costs are generally expensed when incurred.
Nonrefundable advance payments are capitalized and recorded as expense when the respective product or service is delivered.
Accrued Clinical.
Accrued clinical represents
the liability recorded for the costs incurred for our human clinical trials. Total patient costs are based on the specified clinical
trial protocol, recognized over the period of time service is provided to the subject. We had no active clinical trials at December
31, 2015 or December 31, 2014.
Stock-based compensation
. We account for share-based compensation
arrangements in accordance with ASC Topic 718 “Compensation - Stock Compensation” (“ASC 718”). ASC 718
requires all share-based payments, including grants of stock options, restricted stock units and employee stock purchase rights,
to be recognized in our financial statements based on their respective grant date fair values. Under this standard, the fair value
of each grant is estimated on the date of grant using a valuation model that meets certain requirements. We use the Black-Scholes
option pricing model to estimate the fair value of our share-based payment awards. The determination of the fair value of share-based
payment awards utilizing the Black-Scholes model was affected by our stock price and a number of assumptions, including expected
volatility, expected term, risk-free interest rate and an expected dividend yield. We used our historical volatility as adjusted
for future expectations. The expected life of the stock options was based on historical data and future expectations of when the
awards will be exercised. The risk-free interest rate assumption was based on observed interest rates with durations consistent
with the expected terms of our stock options. The dividend yield assumption was based on our history and expectation of dividend
payouts. The fair value of our restricted stock units was based on the fair market value of our common stock on the date of grant.
We evaluated the assumptions used to value our share-based payment awards on a quarterly basis. For non-employees, expense was
recognized as the service was provided and when performance was complete in accordance with ASC Topic 505 – 550 “Equity-Based
Payments to Non-Employees.”
Effective January 1, 2006, stock-based compensation expense recognized
in our financial statements has been based on awards that were ultimately expected to vest. We recognized compensation cost for
an award with only service conditions that had a graded vesting schedule on a straight line basis over the requisite service period
as if the award was, in-substance, a multiple award. However, the amount of compensation cost recognized at any date was at least
equal to the portion of grant-date fair value of the award that was vested at that date. The amount of stock-based compensation
expense is reduced for estimated forfeitures. Forfeitures were required to be estimated at the time of grant and revised, if necessary,
in subsequent periods if actual forfeitures differed from those estimates.
ASC 718 requires the benefits associated with tax deductions that
are realized in excess of recognized compensation cost to be reported as a financing cash flow rather than as an operating cash
flow as previously required. Subsequent to the adoption of ASC 718 on January 1, 2006, we have not recorded any excess tax benefit
generated from option exercises, due to our net operating loss carryforwards, which cause such excess benefits to be unrealized.
The Company recorded stock-based compensation of $174,000 in 2015
and $53,000 in 2014, which increased the net loss. Loss per weighted average basic and diluted shares outstanding increased by
less than $0.01 per share in 2015 and $0.01 per share in 2014 due to stock-based compensation.
Loss per common share
.
In determining loss per common share for a period, we use weighted average shares outstanding during
the period for primary shares and we utilize the treasury stock method to calculate the weighted average shares outstanding during
the period for diluted shares. Utilizing the treasury stock method for the year ended December 31, 2015, 51,000 shares were determined
to be outstanding and excluded from the calculation of loss per share because they were anti-dilutive. At December 31, 2015, options
and warrants to purchase 4,326,835 shares of our common stock, at exercise prices ranging from $0.12 to $6.39 per share, were
outstanding.
Income Taxes.
Under
ASC Topic 740 “Income Taxes” (“ASC 740”), income taxes are recorded based on current year amounts payable
or refundable, as well as the consequences of events that give rise to deferred tax assets and liabilities. We base our estimate
of current and deferred taxes on the tax laws and rates that are estimated to be in effect in the periods in which deferred tax
liabilities or assets are expected to be settled or realized. Pursuant to ASC 740, we have determined that the deferred tax assets
at December 31, 2015 and 2014 require a full valuation allowance given that it is not “more-likely-than-not” that
the assets will be recovered.
We adopted the provisions of Financial Accounting Standards Board
(“FASB”) Interpretation No. 48, “Accounting for Uncertainty in Income Taxes-an interpretation of FASB Statement
No. 109” (now ASC 740) on January 1, 2007. ASC 740 clarifies the accounting for uncertainty in income taxes recognized in
an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement
recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC 740 also provides guidance on
derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition.
Subsequent to adoption of ASC 740, each period we evaluate the tax
years that remain open for assessment for federal and state tax purposes. At December 31, 2015, tax years 2011 through 2015 remain
open.
We may, from time-to-time, be assessed interest or penalties by
major tax jurisdictions, although any such assessments historically have been minimal and immaterial to our financial results.
The Company recognizes accrued interest and penalties, if applicable, related to unrecognized tax benefits in income tax expense.
During the years ended December 31, 2015 and 2014, the Company did not recognize a material amount in interest and penalties.
Patents.
Patent license rights were recorded at $1,045,000,
their estimated fair value on the date they were acquired, August 3, 2012. Their cost will be amortized on a straight-line basis
over the key patent life of eighty months. At December 31, 2015, accumulated amortization totaled $536,000. If a change in conditions
occurs, that indicates a material change in the future utility of the patent license rights, an evaluation will be performed to
determine if impairment of the asset has occurred, and if so, the impairment will be recorded.
Joint Venture Accounting.
The Company entered into a joint
venture in which it has contributed $6,000,000, and the noncontrolling interests have contributed certain patent license rights.
Neither the Company nor the noncontrolling interests have an obligation to contribute additional funds to the joint venture or
to assume any joint venture liabilities or to provide a guarantee of either joint venture performance or any joint venture liability.
The financial position and results of operations of the joint venture are presented on a consolidated basis with the financial
position and results of operations of the Company. Intercompany transactions have been eliminated. Joint venture losses were recorded
on the basis of common ownership equity interests (60% Company / 40% noncontrolling interests) until common ownership equity was
reduced to $0. Subsequent joint venture losses are being allocated to the preferred ownership equity (100% Company). Subsequent
to March 31, 2013, all joint venture losses are being allocated to the Company. The Company has a revolving loan agreement with
the joint venture to advance the joint venture funds for operations in an amount not to exceed a net (net of expected tax credits
or other funds obtained) of $1,500,000, with the net amount due December 31, 2016. Losses incurred by the joint venture in excess
of the capital accounts of the joint venture will be allocated to the Company to the extent of net outstanding advances.
Legal and Other Contingencies
The Company is subject to legal proceedings and claims that arise
in the course of business. The Company records a liability when it is probable that a loss has been incurred and the amount is
reasonably estimable. There is significant judgment required in both the probability determination and as to whether an exposure
can be reasonably estimated. In the opinion of management, there was not at least a reasonable possibility the Company may have
incurred a material loss with respect to loss contingencies. However, the outcome of legal proceedings and claims brought against
the Company are subject to significant uncertainty.
Legal costs related to contingencies are expensed as incurred and
were not material in either 2015 or 2014.
Recent Accounting Pronouncements
In August 2014, the Financial Accounting Standards Board issued
Accounting Standard Update (“ASU”) No. 2014-15,
Presentation of Financial Statements – Going Concern
(Subtopic 205-40)(“Update”): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern,
providing a requirement under U.S. GAAP for an entity’s management to evaluate whether there are conditions or events, considered
in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year
after the date the financial statements are issued; and if those conditions exist, to disclose that fact, the conditions and the
potential effects on the entity’s ability to meet its obligations. The Update will be effective for an annual period ending
after December 15, 2016, with early application permitted
. We have not elected early application, however, if additional funds
are not obtained to continue the development of AEM-28 or its analogs, or operations, it will impair our ability to continue as
a going concern. If we do not continue as a going concern, the Company may incur additional losses, up to, and possibly exceeding
our joint venture investment and revolving loan balance.
At December 31, 2015 and December 31, 2014, investments were classified
as held-to-maturity securities. As of December 31, 2015 and 2014, all investments were in a Money Market Fund with maturities
less than 90 days, and are included in cash and cash equivalents.
3.
|
|
FURNITURE
AND EQUIPMENT
|
The components of furniture and equipment at December 31 are as
follows (in thousands):
|
|
December 31,
|
|
|
2015
|
|
2014
|
Machinery and equipment
|
|
$
|
221
|
|
|
$
|
221
|
|
Furniture and fixtures
|
|
|
34
|
|
|
|
34
|
|
Leasehold improvements
|
|
|
-
|
|
|
|
-
|
|
|
|
|
255
|
|
|
|
255
|
|
Less accumulated depreciation and amortization
|
|
|
(255
|
)
|
|
|
(255
|
)
|
Total
|
|
$
|
-
|
|
|
$
|
-
|
|
Depreciation and leasehold improvement amortization expenses for
the years ended December 31, 2015 and 2014 were $0 and $3,000, respectively.
The components of deferred income taxes at December 31 are as follows
(in thousands):
|
|
December 31
|
|
|
2015
|
|
2014
|
Accruals and reserves
|
|
$
|
1
|
|
|
$
|
1
|
|
Valuation allowance
|
|
|
(1
|
)
|
|
|
(1
|
)
|
Total current
|
|
|
-
|
|
|
|
-
|
|
NOL, AMT and general business credit carryforwards
|
|
|
57,096
|
|
|
|
56,868
|
|
Difference in basis of fixed assets
|
|
|
1
|
|
|
|
3
|
|
Accruals and reserves
|
|
|
75
|
|
|
|
28
|
|
Difference in basis of intangibles
|
|
|
135
|
|
|
|
110
|
|
Difference in currency exchange rate
|
|
|
51
|
|
|
|
46
|
|
Valuation allowance
|
|
|
(57,358
|
)
|
|
|
(57,055
|
)
|
Total non current
|
|
|
-
|
|
|
|
-
|
|
Total deferred income taxes
|
|
$
|
-
|
|
|
$
|
-
|
|
ASC 740 requires that a valuation allowance be established when
it is more-likely-than-not that all or a portion of a deferred tax asset will not be realized. Changes in valuation allowances
from period-to-period are included in the tax provision in the period of change. In determining whether a valuation allowance
is required, we take into account all evidence with regard to the utilization of a deferred tax asset including past earnings
history, expected future earnings, the character and jurisdiction of such earnings, unsettled circumstances that, if unfavorably
resolved, would adversely affect utilization of a deferred tax asset, carryback and carryforward periods, and tax strategies that
could potentially enhance the likelihood of realization of a deferred tax asset. Management has evaluated the available evidence
about future taxable income and other possible sources of realization of deferred tax assets and has established a valuation allowance
of approximately $57 million at December 31, 2015 and $57 million at December 31, 2014. The valuation allowance as of December
31, 2015 and 2014 includes approximately $2.7 million for net operating loss carry forwards that relate to stock compensation
expense for income tax reporting purposes that upon realization, would be recorded as additional paid-in capital. The valuation
allowance reduces deferred tax assets to an amount that management believes will more likely than not be realized.
The components of the income tax provision (benefit) are as follows
(in thousands):
|
|
Years Ended December 31
|
|
|
2015
|
|
2014
|
Provision (benefit) for income taxes
|
|
|
|
|
|
|
|
|
Current
|
|
$
|
(192
|
)
|
|
$
|
(400
|
)
|
Deferred
|
|
|
-
|
|
|
|
-
|
|
Income tax provision (benefit)
|
|
$
|
(192
|
)
|
|
$
|
(400
|
)
|
The 2015 and 2014 income tax benefits result from the Australian
refundable research and development tax credit as explained in Note 7.
We have accumulated approximately $148 million in federal and $24
million in state net operating loss carryforwards (“NOLs”) and approximately $6 million of research and development
and alternative minimum tax credit carryforwards. The federal NOLs expire between 2024 and 2035. The Arizona state NOL’s
expire between 2016 and 2035. The availability of these NOL’s to offset future taxable income could be limited in the event
of a change in ownership, as defined in Section 382 of the Internal Revenue Code.
A reconciliation of the difference between the provision (benefit)
for income taxes and income taxes at the statutory U.S. federal income tax rate is as follows for the years ended December 31,
2015 and 2014:
|
|
Years Ended December 31
|
|
|
2015
|
|
2014
|
Income tax provision (benefit) at statutory rate
|
|
$
|
(942
|
)
|
|
$
|
(1,417
|
)
|
State income taxes
|
|
|
(94
|
)
|
|
|
(165
|
)
|
Research credits
|
|
|
(205
|
)
|
|
|
(435
|
)
|
Expiration of state NOL
|
|
|
497
|
|
|
|
649
|
|
Other
|
|
|
304
|
|
|
|
252
|
|
Change in valuation allowance
|
|
|
248
|
|
|
|
716
|
|
Net provision (benefit)
|
|
$
|
(192
|
)
|
|
$
|
(400
|
)
|
In May 2006, our stockholders approved the 2005 Equity Incentive
Plan (the “2005 Plan”) and reserved 2,000,000 shares of our common stock for issuance. Our stockholders approved the
reservation of an additional 1,750,000 shares of common stock for issuance under the 2005 Plan, which increased the total shares
available for grant under the 2005 Plan to 3,750,000 shares. The 2005 Plan expired in April 2015. In June 2015, our stockholders
approved the 2015 Equity Incentive Plan (the “2015 Plan”) and reserved 1,000,000 shares of our common stock for issuance.
At December 31, 2015, 280,000 shares remained available to grant under the 2015 Plan (the 2005 plan and the 2015 plan are collectively
referred to as “The Plans”). Two types of options may be granted under the Plans: options intended to qualify as incentive
stock options under Section 422 of the Internal Revenue Code (the “Code”) and other options not specifically authorized
or qualified for favorable income tax treatment by the Code. All eligible employees may receive more than one type of option.
Any director or consultant who is not an employee of the Company shall be eligible to receive only nonqualified stock options
under the Plans.
The Plans provide that in the event of a takeover or merger of the
Company in which 100% of the equity of the Company is purchased or a sale of all or substantially all of the Company’s assets,
75% of all unvested employee options will vest immediately and the remaining 25% will vest over the following twelve month period.
If an employee or holder of stock options is terminated as a result of or subsequent to the acquisition, 100% of that individual’s
stock option will vest immediately upon employment termination.
We used the Black-Scholes model with the following assumptions to
determine the total fair value of $174,000 and $53,000 for options to purchase 1,210,000 and 223,000 shares of our common stock
issued during 2015 and 2014, respectively.
|
|
2015
|
|
2014
|
Risk free interest rate
|
|
|
1.6%
|
|
|
|
1.7%
|
|
Volatility
|
|
|
100%
|
|
|
|
100%
|
|
Expected term from vesting
|
|
|
4.4 Years
|
|
|
|
4.2 Years
|
|
Dividend yield
|
|
|
0%
|
|
|
|
0%
|
|
Summary
Non-cash stock compensation cost for the year ended December 31,
2015 and 2014 totaled $174,000 and $53,000, respectively, and was recorded as a general and administrative expense in the Statement
of Operations.
No options were exercised in the years ended December 31, 2015 and
2014.
At December 31, 2015, the remaining unamortized non-cash stock compensation
costs totaled less than $3,000.
A summary of option activity under our stock option plans for the
years ended December 31, 2015 and 2014 is as follows:
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
Weighted
|
|
|
|
Weighted
|
|
average
|
|
|
|
|
average
|
|
|
|
average
|
|
remaining
|
|
|
Number of
|
|
exercise
|
|
Number of
|
|
exercise
|
|
contractual term
|
|
|
Options
|
|
price
|
|
Options
|
|
price
|
|
(years)
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at the beginning of the year:
|
|
|
3,022,706
|
|
|
$
|
1.06
|
|
|
|
3,225,806
|
|
|
$
|
1.52
|
|
|
|
|
|
Granted
|
|
|
1,210,000
|
|
|
$
|
0.22
|
|
|
|
223,000
|
|
|
$
|
0.27
|
|
|
|
|
|
Exercised
|
|
|
-
|
|
|
$
|
-
|
|
|
|
-
|
|
|
$
|
-
|
|
|
|
|
|
Expired / Forfeited
|
|
|
(70,000
|
)
|
|
$
|
1.31
|
|
|
|
(426,100
|
)
|
|
$
|
4.17
|
|
|
|
|
|
Outstanding at end of year
|
|
|
4,162,706
|
|
|
$
|
0.81
|
|
|
|
3,022,706
|
|
|
$
|
1.06
|
|
|
|
5.41
|
|
Options exercisable at year-end
|
|
|
4,031,039
|
|
|
$
|
0.83
|
|
|
|
3,015,374
|
|
|
$
|
1.06
|
|
|
|
5.28
|
|
Options vested and expected to vest at year end
|
|
|
4,075,808
|
|
|
$
|
0.82
|
|
|
|
3,017,685
|
|
|
$
|
1.06
|
|
|
|
5.29
|
|
The Company had no unvested common stock share awards as of December
31, 2015 or December 31, 2014, and no common stock awards were made in 2015 or 2014.
It is the Company’s policy to issue options from stockholder
approved incentive plans. However, if the options are issued as an inducement for an individual to join the Company, the Company
may issue stock options outside of stockholder approved plans. The options granted to employees under stockholder approved incentive
plans have a ten-year term and normally vest over a two to four-year period of service. All stock options are granted with an
exercise price equal to the current market value on the date of grant and, accordingly, stock options have no intrinsic value
on the date of grant. Based on the closing market price of the Company’s common stock at December 31, 2015 of $0.12, stock
options exercisable or expected to vest at December 31, 2015, have no intrinsic value.
Warrants
At December 31, 2015, the Company has fully vested warrants outstanding
to purchase 46,706 shares of the Company’s common stock with an exercise price of $6.39 per share, which expire in February
2016, and fully vested warrants outstanding to purchase 117,423 shares of the Company’s common stock with an exercise price
of $1.91 per share, which expire in July 2016. No warrants were exercised during the years ended December 31, 2015 or 2014.
Rent expense for the years ended December 31, 2015 and 2014, was
$63,000 and $64,000, respectively.
In 2007, the Company entered into a lease for 17,000 square feet
of space in a Tempe, Arizona office and research facility. The term of this lease was sixty months from March 1, 2008. In January
of 2013, this lease was amended to extend the lease to February 28, 2015, with the rentable square feet of space reduced to 2,845
square feet and monthly rental payments of approximately $5,000 plus a proportionate share of building operating expenses and
property taxes. On October 1, 2014 this lease was extended to February 29, 2016 and on February 8, 2016, this lease was extended
to February 28, 2017.
7.
|
|
Australian
Refundable Research & Development Credit
|
In March 2014, LipimetiX Development LLC, (see Note 9 in the financial
statement included in this Form 10-K) formed a wholly-owned Australian subsidiary, Lipimetix Australia Pty Ltd, to conduct Phase
1a and Phase1b/2a clinical trials in Australia. Currently Australian tax regulations provide for a refundable research and development
tax credit equal to 45% of qualified expenditures. Subsequent to the end of its Australian tax years, Lipimetix Australia Pty
Ltd intends to submit claims for a refundable research and development tax credit. The transitional Australian tax periods/years
granted for Lipimetix Australia Pty Ltd end on June 30, 2014, December 31, 2014 and thereafter December 31 of each succeeding
year. For the tax year ended June 30, 2014, Lipimetix Australia Pty Ltd received a refundable research and development tax credit
of AUD$227,000. For the tax year ended December 31, 2014 Lipimetix Australia Pty Ltd received a refundable research and development
tax credit of AUD$301,000 and at December 31, 2015 a AUD$189,000 refundable research and development tax credit has been recorded
by Lipimetix Australia Pty Ltd, as it is more likely than not that the recorded refundable research and development tax credit
at December 31, 2015 will be approved and received.
8.
|
|
AUTHORIZED
PREFERRED STOCK
|
We have 2,000,000 shares of authorized preferred stock, the terms
of which may be fixed by our Board of Directors. We presently have no outstanding shares of preferred stock. Our Board
of Directors has the authority, without stockholder approval, to create and issue one or more series of such preferred stock and
to determine the voting, dividend and other rights of holders of such preferred stock. If we raise additional funds to continue
development of AEM-28 and its analogs, or operations, we may issue preferred stock. The issuance of any of such series of preferred
stock may have an adverse effect on the holders of common stock.
In connection with the Tax Benefit Preservation Plan (“Benefit
Plan”) dated June 24, 2014, between the Company and Computershare (formerly Bank of New York), our Board of Directors approved
the designation of 1,000,000 shares of Series A Preferred Stock. The Benefit Plan and the exercise of rights to purchase Series
A Preferred Stock, pursuant to the terms thereof, may delay, defer or prevent a change in control without the approval of the
Board. In addition to the anti-takeover effects of the rights granted under the Benefit Plan, the issuance of preferred stock,
generally, could have a dilutive effect on our stockholders. The Benefit Plan expires June 24, 2016.
9.
|
|
JOINT VENTURE
FOR DEVELOPMENT OF APO E MIMETIC PEPTIDE MOLECULE AEM-28 AND ANALOGS
|
On August 3, 2012, we entered into a Contribution Agreement with
LipimetiX, LLC to form a joint venture, LipimetiX Development, LLC (“JV”), to develop Apo E mimetic molecules, including
AEM-28 and its analogs. In June 2015, the JV converted from a limited liability company to a corporation, LipimetiX Development,
Inc. The Company contributed $6 million, which included $1 million for 600,000 voting common ownership units (now common stock),
representing 60% ownership in the JV, and $5 million for 5,000,000 non-voting preferred ownership units (now preferred stock),
which have preferential distribution rights.
LipimetiX, LLC contributed all intellectual property rights for
Apo E mimetic molecules it owned and assigned its Exclusive License Agreement between The University of Alabama at Birmingham
Research Foundation (“UABRF”) and LipimetiX, LLC, for the UABRF intellectual property related to Apo E mimetic molecules
AEM-28 and its analogs to the JV, in return for 400,000 voting common ownership units (now common stock) representing 40% ownership
in JV, and $378,000 in cash (for certain initial patent-related costs and legal expenses).
LipimetiX, LLC was formed by the principals of Benu BioPharma, Inc.
(“Benu”) and UABRF to commercialize UABRF’s intellectual property related to Apo E mimetic molecules, including
AEM-28 and analogs. Benu is composed of Dennis I. Goldberg, Ph.D., Phillip M. Friden, Ph.D. and Eric M. Morrel, Ph.D. The Exclusive
License Agreement, as amended, calls for payment of patent filing, maintenance and other related patent fees, as well as a royalty
of 3% on Net Sales of Licensed Products during the Term of the Agreement. The Agreement terminates upon the expiration of all
Valid Patent Claims within the Licensed Patents, which are currently estimated to expire between 2019 and 2035. The Agreement,
as amended, also calls for annual maintenance payments of $25,000, various milestone payments of $50,000 to $500,000 and minimum
royalty payments of $500,000 to $1,000,000 per year commencing on January 1 of the first calendar year following the year in which
the First Commercial Sale occurs. UABRF will also be paid 5% of Non Royalty Income received.
Concurrent with entering into the Contribution Agreement and the
First Amendment and Consent to Assignment of Exclusive License Agreement between LipimetiX, LLC, UABRF and the Company, the Company
and LipimetiX, LLC entered into a Limited Liability Company Agreement for JV which established a Joint Development Committee (“JDC”)
to manage JV development activities. Upon conversion by the JV from a limited liability company to a corporation, the parties
entered into a Stockholders Agreement for the JV, and the JDC was replaced by a Board of Directors (JV Board). The JV Board is
composed of three members appointed by the non-Company ownership group and two members appointed by the Company. Non-development
JV decisions, including the issuance of new equity, incurrence of debt, entry into strategic transactions, licenses or development
agreements, sales of assets and liquidation, and approval of annual budgets, will be decided by a majority vote of the common
stockholders.
The JV, on August 3, 2012, entered into a Management Agreement with
Benu to manage JV development activities for a monthly fee of approximately $63,000 during the twenty-seven month development
period, and an Accounting Services Agreement with the Company to manage JV accounting and administrative functions. The current
accounting services fee is $1,000 a month. Commencing in November 2014, and ending in March 2015, Benu received a reduced monthly
management fee in the amount of $35,000. Subsequent to March 2015, a management fee of $150,000 was paid to Benu for their services.
No management fees are owed at December 31, 2015.
The joint venture formation was as follows ($000’s):
Patent license rights
|
|
$
|
1,045
|
|
Noncontrolling interests
|
|
|
(667
|
)
|
Cash paid at
formation
|
|
$
|
378
|
|
Patent license rights were recorded at their estimated fair value
and are being amortized on a straight-line basis over the key patent life of eighty months.
The financial position and results of operations of the joint venture
are presented on a consolidated basis with the financial position and results of operations of the Company. Intercompany transactions
have been eliminated. The joint venture agreement requires profits and losses to be allocated on the basis of common ownership
equity interests (60% Company / 40% noncontrolling interests). However, for the Company’s consolidated financial statement,
joint venture losses were recorded on the basis of common ownership equity interests (60% Company / 40% noncontrolling interests)
until common ownership equity was reduced to $0. Subsequent joint venture losses have been allocated to the preferred ownership
equity (100% Company). Subsequent to March 31, 2013, all joint venture losses have been allocated to the Company. The Company
has a revolving loan agreement with the joint venture to advance the joint venture funds for operations in an amount not to exceed
a net (net of expected tax credits or other funds obtained) of $1,500,000, with the net amount due December 31, 2016. Losses incurred
by the joint venture in excess of the capital accounts of the joint venture will be allocated to the Company to the extent of
net outstanding advances. At December 31, 2015, outstanding advances on the revolving loan agreement totaled $1,510,000.
The joint venture incurred operating expenses, prior to the elimination
of intercompany transactions, of $959,000 in 2015 and $7,194,000 for the period from August 3, 2012 (inception) to December 31,
2015, of which $959,000 and $6,527,000, respectively, have been allocated to the Company. The joint venture operating expenses
are included in research and development expenses in the condensed consolidated statements of operations.
Neither the Company nor the noncontrolling interests have an obligation
to contribute additional funds to the joint venture or to assume any joint venture liabilities or to provide a guarantee of either
joint venture performance or any joint venture liability. Losses allocated to the noncontrolling interests represent an additional
potential loss for the Company as the noncontrolling interests are not obligated to contribute assets to the joint venture to
the extent they have a negative capital account, and depending on the ultimate outcome of the joint venture, the Company could
potentially absorb all losses associated with the joint venture. From formation of the joint venture, August 3, 2012, through
December 31, 2015, losses totaling $667,000 have been allocated to the noncontrolling interests. If the joint venture or Company
is unable to obtain additional funding, the ability of the joint venture to continue development of AEM-28 and its analogs would
be impaired as would the joint venture’s ability to continue operations. If the joint venture does not continue as a going
concern, at December 31, 2015 the Company would incur an additional loss of $667,000 for the joint venture losses allocated to
the noncontrolling interests.
10.
|
|
NOTE PAYABLE
– FUNDRAISING ACTIVITIES
|
As disclosed above, management has determined that the Company will
require additional capital above its current cash and working capital balances to further develop AEM-28 and its analogs and to
continue operations. Accordingly, the Company has reduced its development activities. The Company’s corporate
strategy is to raise funds either by the Company, or directly in its joint venture, by possibly engaging in a strategic/merger
transaction, or conducting a private or public offering of debt or equity securities for capital. In connection
with these efforts, we filed a Registration Statement on Form S-1 with the Securities and Exchange Commission on June 26, 2015,
as amended, in connection with our contemplated public offering of shares of our Common Stock. The Registration Statement was
not effective as of December 31, 2015 and was withdrawn in January 2016. All costs relating to these fundraising activities have
been expensed at December 31, 2015.
On December 11, 2015, we entered into a Securities Purchase Agreement
(the “Agreement”) with Biotechnology Value Fund affiliated entities Biotechnology Value Fund, L.P., Biotechnology
Value Fund II, L.P., Biotechnology Value Trading Fund OS, L.P., Investment 10, LLC, and MSI BVF SPV, LLC (the "Lenders"),
to provide short-term funding for our operations. A portion of the funds will be advanced to JV, to initiate preclinical development
activities for our lead commercial drug candidate, AEM-28-14. The Lenders, at December 31, 2015, owned in the aggregate, approximately
19% of our outstanding Common Stock, par value $.0005 per share ("Common Stock").
Pursuant to the Agreement, the Lenders funded an aggregate of $1,000,000
of loans to us, evidenced by Convertible Promissory Notes (the “Notes”) dated December 11, 2015 and due April 30,
2017. The Notes bear interest at 5% per annum and are secured by a security interest in all of our assets.
The unpaid principal amount of the Notes will convert automatically
upon the closing of a Qualified Equity Financing, which is defined in the Agreement as an offering of equity securities with aggregate
gross proceeds of at least $5,000,000 including the principal of any converted Notes. Such conversion will be into the same securities
and on the same terms as provided for the other investors in the Qualified Equity Financing.
If a Qualified Equity Financing is not consummated by March 31,
2016, the unpaid principal amount of the Notes may be converted at the election of the Lenders into shares of Common Stock, at
a conversion price (the "Optional Conversion Price") equal to the trailing 10-day weighted average trading price of
the Common Stock, but not be less than $.135 or more than $.18 per share. Upon a change in control of the Company, the Lenders
may elect to accelerate the Notes or convert them into Common Stock at a conversion price equal to the Optional Conversion Price.
Under the Agreement, the Lenders have the right to elect to acquire,
upon conversion of the Notes, convertible preferred stock rather than Common Stock, such preferred stock to vote with the Common
Stock and to be convertible into the equivalent number of shares of Common Stock as would have been originally issued if the Notes
conversion had been into Common Stock. Such preferred shares would have no preferential liquidation or distribution rights and
would not have any dividend or preferred return rights.
The Agreement grants Lenders an Exclusive Period, initially ending
January 31, 2016, to propose terms of an additional investment of at least $7,500,000, but not to exceed $10,000,000, in the Company
(the “Proposed Investment”). The Agreement provides that it is expected that the Proposed Investment will involve
the issuance of units at a price of $.18 per unit, with each unit composed of one share of Common Stock and a five-year warrant
to purchase one-half of a share of Common Stock at an exercise price equal to 125% of the unit price, and that the investors would
be entitled to nominate a majority slate of directors. However, neither the Lenders nor we are obligated under the Agreement to
proceed with a Proposed Investment, or to proceed with a Proposed Investment on these terms. The Lenders had the right to extend
the Exclusive Period to March 31, 2016 by funding an additional $1,000,000 aggregate of bridge loans on the same terms as the
initial advance pursuant to the Notes. We agreed that during the Exclusive Period, we would not consummate the offering originally
contemplated in our Form S-1 registration statement initially filed with the Securities and Exchange Commission on June 26, 2015.
On January 29, 2016, the Lenders informed the Company that they would not exercise their right to extend the Exclusive Period
or to proceed with a Proposed Investment.
11.
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SUBSEQUENT
EVENT -
Contingency – Non-Compliance with
Securities and Exchange Commission Reporting Requirements and OTCQB Market Requirements.
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Our current level of funds available for operation has led to additional
cost cutting, which included the decision to not engage an independent public accountant to audit and express an opinion on our
December 31, 2015 financial statements included in this Annual Report on Form 10-K, as required by current SEC rules and regulations,
and as required to be listed on the OTCQB Market. We cannot currently predict the response to this action by the SEC or the OTCQB
Market, nor the effects of their action, on the continued financial viability of the Company or the trading of its common stock.
The decision to not engage an independent public accountant to audit and express an opinion on our December 31, 2015 financial
statements could have a material adverse effect on the Company and its Stockholders.
F-18