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(Exact name of Registrant as specified in its charter)
C:
C:C:
Delaware
27-0125925
(State or other jurisdiction of
(I.R.S. Employer
incorporation or organization)
Identification No.)
C:
170 N. Radnor-Chester Road; Suite 300 Radnor, PA19087
(Address of principal executive offices including zip code)
(484) 598-2332
(Registrant’s telephone number)
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act: Common Stock, $0.001 par value
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of
the Securities Act. o Yes þ 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. o
Indicate by check whether the registrant: (1) filed all reports required to be filed by Section 13
or 15(d) of the Securities Exchange Act 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
requirement for the past 90 days. þ Yes o 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 amendments to this Form 10-K. o
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer, or a smaller reporting company. See the definitions of “large
accelerated filer,”“accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act. (Check one):
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Accelerated filer o
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(Do not check if a smaller reporting company)
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the
Act). o Yes þ No
The aggregate market value of the registrant’s common stock, $0.001 par value per share, held by
non-affiliates of the registrant on June 30, 2007 was approximately $50,504,000 (based on the
closing sales price of the registrant’s common stock on that
date ($2.10)).
The number of shares of the issuer’s common stock outstanding as of March 26, 2008 was 32,068,726.
The registrant’s definitive proxy statement to be filed in connection with solicitation of proxies
for its 2008 Annual Meeting of Stockholders to be held within 120 days of the end of its fiscal
year, is incorporated by reference into Part III of this Annual Report on Form 10-K.
This report contains forward-looking statements within the meaning of Section 27A of the Securities
Act, Section 21E of the Securities Exchange Act of 1934, as amended and the Private Securities
Litigation Reform Act of 1995 that are subject to risks and uncertainties. You should not place
undue reliance on those statements because they are subject to uncertainties and factors relating
to our operations and business environment, all of which are difficult to predict and many of which
are beyond our control. Forward-looking statements include statements regarding our plans,
objectives, goals, strategies, future events, capital expenditures, future results, our competitive
strengths, our business strategy our industry trends and other statements regarding matters that
are not historical facts. These statements often include words such as “may,”“believe,”“expect,”“anticipate,”“intend,”“plan,”“estimate” or similar expressions. These statements are based on
assumptions that we have made in light of our industry experience as well as our perceptions of
historical trends, current conditions, expected future developments and other factors we believe
are appropriate under the circumstances. As you read and consider this report, you should
understand that these statements are not guarantees of performance or results. They involve risks,
uncertainties and assumptions. Although we believe that these forward-looking statements are based
on reasonable assumptions, you should be aware that many factors could affect our actual financial
results or results of operations and could cause actual results to differ materially from those in
the forward-looking statements. These factors include but are not limited to:
Ø
our need for and available of substantial capital to fund our operations and clinical
trials planned for 2008 and beyond;
Ø
the timing of our product development and evaluation;
Ø
the timing and magnitude of expenditures we may incur in connection with our ongoing
research and development activities;
Ø
the results of our preclinical and clinical trials, including regulatory approvals;
Ø
the timing and financial consequences of our formation of new business relationships and alliances; and
Ø
the timing and volume of sales of products for which we obtain marketing approval.
You should keep in mind that any forward-looking statement made by us in this report speaks only as
of the date of this report. We have no duty to, and do not intend to, update or revise the
forward-looking statements in this report after the date of this report.
This Business section outlines both how we perceive the current status of our business initiatives
as well as our plans to further develop our business and product portfolio. We do not currently
have the funding resources necessary to carry out all of our short and long-term operating
activities. We plan to secure additional funding during 2008. If we are unable to secure adequate
additional funding, we will delay, scale-back or eliminate certain of our research, drug discovery
or development activities or certain other aspects of our operations and our business until such
time as we are successful in securing adequate additional funding.
SUMMARY:
We are a biotechnology company focused on treating life threatening, serious, infectious diseases
and acute cardiovascular disorders with synthetic small molecule compounds that mimic the activity
of large natural protein molecules, compounds referred to as biomimetics. Using our proprietary
computational drug design technology, we have created novel defensin mimetic antibiotic compounds,
heparin antagonist compounds (or “heptagonist”) and other drug compounds intended for human
therapeutic use. The following chart illustrates the current stage of development of our
internally developed pipeline along with planned development timings for our two lead clinical
programs:
Product Candidate
Discovery
Drug Development
IND
Phase 1
Phase II
Start
Finish
Start
Finish
Clinical Stage Compounds:
PMX-30063 (defensin mimetic i.v. antibiotic)
Q2 2008
Q4 2008
Q1 2009
Q4 2009
PMX-60056 — Heptagonist (UFH and LMWH reversing agent)
Defensin mimetic antibiotics are compounds that have a novel mechanism-of-action that mimics the
antimicrobial activity of host defense proteins, a group of proteins naturally found in most higher
forms of life including humans, which provide the first line of defense against bacterial
infections. We believe that bacteria are less likely to develop resistance to antibiotic products
with this mechanism-of-action than currently marketed antibiotics. Most antibiotics exert their
activity by interacting with a specific biochemical molecular target or pathway, such as an enzyme.
Bacteria can often develop mutations in these molecular targets in a process called “target
mutation”, which renders
the antibiotic drug unable to interact with its intended biochemical target. Additionally, bacteria
can sense that a foreign chemical has entered its cell and can pump it out before it can bind to
its intended biochemical target, through a process called efflux. Both of these factors can cause
bacteria to become drug-resistant. Instead of relying on a specific molecular target that can
mutate, our product candidates target the entire bacterial cell membrane. Our defensin mimetic
antibiotic product candidates destabilize the bacterial cell membrane and cause either leakage of
cellular content or complete disruption of the membrane, which results in bacterial cell death.
Additionally, because our product candidates target the bacterial cell membrane and do not have to
enter the cell, the opportunity for bacterial efflux is reduced. We believe this
mechanism-of-action makes it unlikely for bacteria to develop resistance to our defensin mimetic
antibiotic product candidates.
Worldwide, the hospital antibiotic market is $8 billion, treating approximately seven million
patients per year and the total worldwide antibiotic market is $26 billion, treating approximately
49 million patients per year. According to the Centers for Disease Control and Prevention, or CDC,
bacterial infections are the fourth leading cause of death in the U.S. and are one of the fastest
growing causes of death. Because of the increasing rate of bacterial resistance and the
corresponding death rate, we believe there is a significant medical and market need for a new class
of antibiotics, defensin mimetics, with a novel mechanism of action designed to make it unlikely
for bacteria to develop resistance.
We are currently working to scale up manufacturing of clinical supplies for our lead antibiotic
compound, PMX-30063, under GMP (Good Manufacturing Practices) conditions. The GLP (Good Laboratory
Practices) compliant toxicology, safety pharmacology and genotoxicity studies have been completed,
which indicate that an effective therapeutic index for PMX-30063 may be achieved. We expect that
our first defensin mimetic antibiotic product candidate will be an i.v. formulation intended to
treat respiratory tract infections, urinary tract infections and complicated skin and soft tissue
infections, including gynecological infections. We anticipate that the bacterial targets of
PMX-30063 will include drug resistant strains, particularly broadly targeting the various strains
of Staph bacteria. We expect to file an Investigative New Drug application, or IND, (or foreign
equivalent) for PMX-30063 and commence Phase I human clinical trials during the second quarter of
2008. The Phase I studies will include (i) a single dose study of healthy volunteers receiving
PMX-30063 at various dose levels (Phase 1A) and (ii) a multi-dose study of healthy volunteers who
receive PMX-30063 at various dose levels (Phase 1B). The primary endpoint for the two Phase 1
studies will be a safety assessment. We plan to complete the Phase 1A study in the third quarter
of 2008 and plan to complete the Phase 1B study in the fourth quarter of 2008. Phase II studies
are planned for 2009. If adequate financing is not secured during the first half of 2008, we will
delay or scale-back this program until additional funding is secured.
Heptagonists such as PMX-60056, our second development program, are compounds that bind to and
thereby reverse the anticoagulant effects of heparin, a class of commonly used blood clot
prevention drugs. Unfractionated heparin (or UFH) is commonly used in numerous surgical
applications, such as cardiothoracic procedures, and Low Molecular Weight Heparins (or LMWH) are
commonly used in patients under longer-term administration, because of their ease of administration
and longer half-life. Overdoses of UFH or LMWH are dangerous due to potentially life-threatening
bleeding. While widely used, UFH and LMWH have the possibility of adverse bleeding side effects,
which requires frequent monitoring. Protamine is the only available reversing agent for UFH. It is
used as both an antidote in the event of overdose and, more commonly, in standard treatment
following coronary artery bypass grafts in which post-operative treatment involves administering
protamine to counter the action of UFH, which is to prevent blood clots while a patient is on a
heart-lung support machine. While widely used to reverse UFH, protamine has a number of adverse
side effects, including bleeding, difficulty and complexity in dose titration, allergic reactions,
immunogenicity, and abnormal clot formation, all of which require frequent monitoring and follow
up. As a result, there is a significant medical and market need for a safer UFH antagonist.
Additionally, there is currently no approved antagonist agent for LMWH.
Worldwide, we estimate that approximately two million extracorporeal blood procedures, including
cardiothoracic procedures, are performed per year that utilize heparin and may require UFH
reversal, and approximately twelve million patients receive LMWH per year for a variety of uses,
including deep vein thrombosis, post heart attack, cancer, and atrial fibrillation. There have been
several published studies which demonstrate that up to 20% of LMWH patients experience clinically
significant bleeding, and up to 4% of cases are considered to be serious or life threatening. The
availability of an antidote to LMWH would allow patients experiencing a LMWH bleeding event to be
pharmaceutically treated. Additionally, the availability of a reversing agent for LMWH could allow
LMWH to
be used in cardiothoracic surgical procedures or in patients who may need to undergo re-operation.
Thus, an LMWH antagonist could substantially increase the market and sales of LMWH drugs.
We are currently working to scale up manufacturing of clinical supplies for our lead heptagonist
compound, PMX-60056, under GMP conditions. The GLP compliant toxicology, safety pharmacology and
genotoxicity studies have been completed, which indicate that an effective therapeutic index for
PMX-60056 may be achieved. We expect to file an IND (or foreign equivalent) for PMX-60056 and, with
additional financing, expect to commence Phase I human clinical trials during the second quarter of
2008. The Phase I studies will include (i) a study of healthy volunteers receiving PMX-60056 at
various dose levels (Phase 1A) and (ii) a study of heparinized healthy volunteers who receive
PMX-60056 at various dose levels (Phase 1B). While the primary endpoint for the two Phase 1
studies will be a safety assessment, we also will be able to gather efficacy data in the Phase 1B
study. We plan to complete the Phase 1A study in the third quarter of 2008 and plan to complete
the Phase 1B study in the fourth quarter of 2008. Phase II studies are planned for 2009. If
adequate financing is not secured during the first half of 2008, we will delay or scale-back this
program until additional funding is secured.
Pre-Clinical Stage Compounds:
In order to achieve the best balance of financial rate of return with risk and timing to market, we
also intend, pending sufficient additional financing, to conduct pre-clinical development of our
antibiotic compounds for both topical and oral antibiotic applications. The initial topical
application we are pursuing is an ophthalmic antibiotic for the treatment of eye infections, and
the initial oral application we are investigating is a non-absorbed antibiotic for the treatment of
gastrointestinal infections such as Clostridium difficile. Pending sufficient additional financing,
we hope to advance pre-clinical development and file additional IND applications for the ophthalmic
topical and non-absorbed oral antibiotic indications.
We are also evaluating our antibiotic compounds for a number of other topical applications,
including use for skin structure infections, oral healthcare applications for treatment of
periodontal disease, a type of gum disease, topical treatment for ear infections, topical treatment
of fungal infections, topical treatment of acne, and a variety of non-therapeutic applications in
personal care and materials applications.
CLINICAL PROGRAMS:
Defensin Mimetic Antibiotic Product Candidate
Market Opportunity
Worldwide, more than seven million patients are hospitalized each year for bacterial infections,
with approximately 49 million total patients being treated for infections. Approximately 90,000
people in the U.S. die as a result of healthcare acquired infections according to the CDC.
According to a 2001 article published in Emerging Infectious Diseases, healthcare-acquired
infections cost approximately $4.5 billion annually in the U.S. The same article estimates that
drug-resistant bacteria cause more than 70% of healthcare-acquired infections. A February 2008
report from the Association for Professionals in Infection Control and Epidemiology (APIC)
estimates that 70% of infections may now be resistant to antibiotics. As drug-resistance continues
to spread, the need for potent novel antibiotic drugs increases.
According to DataMonitor, a provider of healthcare market analysis data, the world’s antibiotic
market was approximately $25.5 billion in 2005 after growing at a compound annual growth rate of
5.1% between 2001 and 2005. DataMonitor further estimates that the U.S. market for all antibiotic
drugs was approximately $10.8 billion in 2004. The portion of the antibiotic market that we
initially intend to target is the North American acute-care hospital market. This market includes
intravenous or subcutaneously infused products that are administered, or at least prescribed, in
the hospital. According to IMS Health, another leading provider of healthcare market analysis data,
the size of this market during the twelve months ended August 2004 was approximately $3 billion.
Host Defense Proteins
Our small molecule defensin mimetic antibiotic product candidates mimic the activity of host
defense proteins. Host defense proteins are part of the innate immune system. In the human body,
host defense proteins primarily exist in the respiratory tract, the urogenital tract, the
gastrointestinal track and the epidermal tissues under the skin, all
locations where microbial pathogens first enter the human body, and represent a first line of
defense against bacterial attack. Host defense proteins are also important because they act rapidly
against bacteria, unlike other parts of the immune system that take longer to work.
Host defense proteins use a simple, but effective method for killing bacteria. They target
bacterial membranes and disrupt them using a combination of two mechanisms. At low doses, these
antimicrobial proteins associate in membranes causing membrane thinning and formation of transient
pores leading to membrane permeabilization and leakage of cellular ions and metabolites, which
results in the killing of the bacterial cell. At higher doses, they cause generalized disruption of
the bilayer structure of the membrane, leading to the complete breakdown of the bacterial membrane
and leakage of cellular contents, which results in the killing of the bacterial cell.
Antibiotics on the market today generally target specific molecular targets in bacteria and many
must enter the bacteria cell to work. Bacterial cells can become resistant to antibiotics through:
Ø
genetic mutations that modify the molecular targets themselves, rendering them
invulnerable to the antibiotic in question; or
Ø
metabolic responses that cause the cell to pump out foreign agents, preventing the
antibiotics from accessing the molecular targets.
By contrast, host defense proteins physically disrupt the cell from the outside. The
mechanism-of-action of the host defense proteins makes it difficult for bacteria to develop
resistance because of several reasons:
Ø
they do not have to enter the bacterial cell to work;
Ø
they act quickly, killing bacteria within minutes of exposure, thereby limiting the
bacterial response time; and
Ø
in order to develop effective defenses, the bacteria would have to alter the structure
of its cell membrane, which is a highly complex multi-step response that would likely
reduce the ability of the newly mutated bacteria to grow and survive in a natural
environment due to changes in membrane transport of essential nutrients and wastes.
It has been documented in many studies published by the American Society of Microbiology and others
that susceptible bacteria do not readily develop resistance to host defense proteins under
experimental conditions where resistance readily develops against conventional antibiotics.
Furthermore, bacteria remain sensitive to the host defense proteins despite hundreds of millions of
years of evolution in which bacteria have been exposed to host defense proteins’ antimicrobial
mechanism-of-action.
Another favorable attribute of host defense proteins is that they selectively target bacteria and
not mammalian cells, by recognizing the differences in the composition of bacterial and mammalian
cell membranes. The outer surface of bacterial cell membranes is more negatively charged than
mammalian cells. Bacterial cell membranes also lack cholesterol, an essential component of all
mammalian membranes. Host defense proteins specifically target membranes that lack cholesterol and
have a high degree of negative electrical charge. Therefore, they selectively attack bacterial cell
membranes while mitigating harm to mammalian cells.
We believe that the host defense proteins provide an attractive mechanistic approach for the
development of a new type of antibiotic therapeutic drug due to their strong antimicrobial
activity, unique mechanism-of-action for which bacterial resistance appears less likely to develop,
and selective targeting of bacteria but not mammalian cells. Attempts were made in the past by
other companies to develop natural host defense proteins as novel antibiotics. Those products
lacked robust activity in models of systemic infection, and were studied for niche topical
applications, likely as a result of their limited systemic availability. None of them has been
successfully commercialized to date because of difficulties relating to some of the inherent
complexities associated with protein drugs: a lack of systemic bioavailability and stability. For
systemic applications, all protein drugs have a number of limitations, including often not being
bioavailable with either injectable or oral administration, often expensive to produce, often
unstable even with intravenous administration, and at risk of eliciting immunological reactions
which can neutralize their activity.
We have developed PMX-30063, our lead defensin mimetic antibiotic product candidate, and other
novel small molecule defensin mimetic antibiotics that mimic the activity of host defense proteins.
We are seeking to commercialize these defensin mimetic compounds as antibiotics in a variety of
forms to combat drug-resistant bacterial infections. PMX-30063 and other defensin mimetic
antibiotic product candidates are completely synthetic, which make them easier and less expensive
to produce than proteins. Importantly, our small molecule compounds demonstrate activity in animal
models of systemic infection, activity that was lacking in past attempts to develop natural host
defense proteins. These defensin mimetic antibiotic product candidates may be developed in a
variety of formulations, including injectable, tablet and topical, for a wide range of antibiotic
applications. The results of our preclinical experiments for PMX-30063 and other defensin mimetic
antibiotic product candidates suggest several advantages compared to other marketed antibiotics.
Such advantages include:
Ø
Broad spectrum of activity, including against resistant bacterial strains. By acting on
bacterial cell membranes, we believe our antibiotics will be effective against a broad
range of Gram-positive and Gram-negative pathogens. In our in vitro efficacy studies, our
defensin mimetic antibiotic product candidates as a class demonstrated potent antibacterial
activity on hundreds of common bacterial pathogens. To support our initial clinical target
of broad treatment of Staphylococcus infections, we have also demonstrated activity against
148 different strains and species of Staph, including 89 drug-resistant strains. The
antibacterial activity of our defensin mimetic antibiotic product candidates has also been
demonstrated in animal models of systemic infections.
Ø
Lower likelihood for the development of drug-resistance. It is very difficult for
bacteria to develop drug resistance to natural antimicrobial host defense proteins because
these proteins act on bacterial membranes rather than on a single, mutable molecular
target, such as an enzyme. Because our defensin mimetic antibiotic product candidates are
designed to have the same mechanism-of-action as host defense proteins, we anticipate them
to have a similar lower likelihood of developing bacterial resistance compared to
conventional antibiotics. This reduced likelihood of bacterial resistance has also been
demonstrated in laboratory serial passage experimental studies.
Ø
Potentially faster acting than other antibiotics. In time-kill studies, our defensin
mimetic antibiotic product candidates act quickly when bacteria are exposed to them. We
observed bactericidal activity in a matter of minutes after exposure to our defensin
mimetic antibiotic product candidates. In contrast, many currently marketed drugs can take
hours or even several days to show effect.
Preclinical Experiments
Our preclinical research indicates that PMX-30063, our lead defensin mimetic antibiotic product
candidate, has a number of favorable attributes, including relatively low molecular weight, potent
and broad spectrum antibacterial activity, low cytotoxicity, good tolerance in acute toxicity and
repeat dose animal experiments and strong efficacy in animal models of bacterial infection. Our
defensin mimetic antibiotic product candidates have demonstrated efficacy in preclinical
experiments against strains of bacteria that are currently resistant to one or more classes of
currently available antibiotics. Due to the novel mechanism-of-action of our product candidates and
the results of our preclinical research, we believe it is less likely that resistance will develop
against our defensin mimetic antibiotic product candidates compared with conventional antibiotic
drugs. The results of certain of our preclinical experiments for PMX-30063 are discussed below.
Bacterial Resistance
We employed a serial passage method to measure the potential development of bacterial drug
resistance to PMX-30063. In serial passage experiments, bacteria are repeatedly exposed to
sub-lethal concentrations of a drug, which accelerates the over-growth of mutant forms of bacteria
that are resistant to the action of an antibiotic drug. In our experiments, we compared PMX-30063
with norfloxacin, a widely used broad-spectrum antibiotic drug. Resistance by Staph bacteria,
including MRSA, was readily observed for norfloxacin, whereas no resistance was observed for
PMX-30063. In similar studies performed by a contract research organization, no resistance
developed to our defensin mimetic antibiotic compounds when bacterial strains that were resistant
to other antibiotics were used in the test. These results are consistent with those that have been
previously demonstrated with host defense proteins.
Pharmacokinetics is the study of how a compound behaves in the body. Efficacy studies determine how
effective a compound is for its intended use, in this case, PMX-30063 as an antibiotic agent.
Pharmacokinetic and efficacy studies are performed to establish the most effective dosage levels.
Pharmacokinetic analysis has been completed for PMX-30063 in a mouse model. In these experiments,
blood samples were collected at nine time points over 24 hours and quantified. One of the important
measurements in these blood sample studies is half-life, which measures the time it takes for half
of an administered dose of compound to be cleared from the body. These measurements guide how often
a compound needs to be administered. PMX-30063 generally exhibited half-lives in the range of 0.81
hours to 2.66 hours, which is comparable to the half-life of several antibiotics widely used in the
hospital setting.
Proteins and other components in blood can have significant effects on the activities of drug
candidates, such as loss of antimicrobial activity. Our preclinical research suggests that
PMX-30063 is stable and the antimicrobial activity is maintained in the presence of blood serum.
These serum-effect profiles compare very favorably with many marketed antibiotic drugs.
In Vitro Activity
PMX-30063 has demonstrated potent and selective in vitro antibacterial activity. In our preclinical
experiments, PMX-30063 demonstrated potent activity against both Gram-positive and Gram-negative
bacteria, two general classes of bacteria, as well as fungi. Potent activity is found against
bacteria isolated from human infections including two important hospital pathogens,
methicillin-resistant S. aureus, or MRSA, and vancomycin resistant enterococcus, or VRE. Overall,
our defensin mimetic antibiotic compounds as a class have demonstrated antimicrobial activity
against a broad spectrum of over 100 strains of bacteria, including clinical isolates of
Gram-positive and Gram-negative bacteria.
In Vitro Metabolism
Metabolism studies seek to determine what happens to a compound after it has been administered to a
body, if it is changed in the body, and how it may be eliminated from the body. PMX-30063 has been
tested for stability in the presence of mouse and human liver microsomes to investigate the extent
to which liver metabolism could be a factor upon compound administration. PMX-30063 demonstrated
high stability in the presence of liver microsomes. This data suggests that PMX-30063 should be
metabolically stable.
Animal Efficacy and Toxicology Studies
The following animal efficacy and toxicology data provides important proof-of-concept information
that we believe supports development of PMX-30063 as a novel antibacterial agent for systemic
infections. We have conducted additional efficacy studies in both mice and rats using intravenous
infusions to examine the activity of PMX-30063 in clinically validated models of bacterial
infection to find a dosing regimen that would maximize the tolerability of PMX-30063. Additional
pharmacokinetic, toxicology and safety pharmacology studies were also conducted to fully evaluate
PMX-30063.
Thigh burden model. The thigh burden model is a widely used and accepted animal model for
evaluating antibacterial activity of antibiotic drugs, such as PMX-30063, in animals. Mice were
inoculated in the thigh muscle with S. aureus and then treated with our PMX-30063 by intravenous
bolus administration. PMX-30063 significantly reduced the bacterial burden in thighs compared to
the inoculated control treatment of saline even when first administered one hour after inoculation
with bacteria.
Sepsis model. We also tested the antibacterial efficacy of PMX-30063 in a mouse sepsis model. In
our studies, we infected mice with S. aureus at 100 times the lethal dose through injections into
the body cavity. These animals were then treated with either vancomycin or PMX-30063. All animals
were observed for mortality over seven days following treatment. This is a stringent test of a
compound as it involves a severe infection and the drug must both work quickly, and be able to
reach many body compartments from the bloodstream at sufficiently high concentrations to kill the
infectious bacteria for the animals to survive. When left untreated, the infected mice all died
within one day. Mice treated with PMX-30063 demonstrated comparable to superior survival rates to
mice treated with vancomycin. These studies demonstrate that when delivered intravenously,
PMX-30063 can be
distributed throughout the body and reach the compartments needed to effectively treat bacterial
infection.
Toxicology Testing. Toxicology studies are done to determine the difference between the dose at
which a compound is effective and the dose at which it demonstrates toxicity. These studies and
measurements are done to determine the ratio between the toxic and effective doses. This ratio is
referred to as the therapeutic index or selectivity ratio. Single and multi-dose acute toxicity
studies have been completed with PMX-30063 in mice and rats to determine the highest dose where no
apparent toxicities or adverse behavioral responses are observed. Our results demonstrated that
PMX-30063 is better tolerated when administered by intravenous infusion rather than by bolus
intravenous injection, and generally suggest that an acceptable therapeutic index may be achieved,
meaning that effective doses are less than toxic doses. Results from these studies suggest that an
acceptable therapeutic index for PMX-30063 may be achieved.
Development Plan
We are currently working to scale up manufacturing of clinical supplies for our lead antibiotic
compound, PMX-30063, under GMP conditions. The GLP compliant toxicology, safety pharmacology and
genotoxicity studies have been completed, which indicate that an effective therapeutic index for
PMX-30063 may be achieved. Our first product candidate will be an i.v. formulation intended to
treat respiratory tract infections, urinary tract infections and complicated skin and soft tissue
infections, including gynecological infections, caused by strains of Staph bacteria. We anticipate
that the bacterial targets of PMX-30063 will include drug resistant strains, particularly broadly
targeting the various strains of Staph bacteria. In the future, we also hope to expand indications
to also potentially include other bacterial strains such as Pseudomonas, Streptococcus, and
Enterococcus. We expect to file an IND (or foreign equivalent) for PMX-30063 and commence Phase I
human clinical trials during the second quarter of 2008. The Phase I studies will include (i) a
single dose study of healthy volunteers receiving PMX-30063 at various dose levels (Phase 1A) and
(ii) a multi-dose study of healthy volunteers who receive PMX-30063 at various dose levels (Phase
1B). The primary endpoint for the two Phase 1 studies will be a safety assessment. We plan to
complete the Phase 1A study in the third quarter of 2008 and plan to complete the Phase 1B study in
the fourth quarter of 2008. Phase II studies are planned for 2009. If adequate financing is not
secured during the first half of 2008, we will delay or scale-back this program until additional
funding is secured.
After Phase I, our plan is to investigate and pursue one of the accelerated development and/or
regulatory processes, which may be granted by the FDA to speed up the review process for products
that address an unmet medical need. These paths include: “fast track,” which is based on
recognition by the FDA of medical need; “priority review,” which provides for a six-month review
time after filing of a New Drug Application, or NDA; and “accelerated approval,” under which drugs
for serious or life threatening disorders for which there is an unmet medical need may be approved
based on Phase II clinical data or surrogate clinical markers, with a requirement to complete
studies and show clinical outcomes. Drugs to treat HIV, the virus that causes AIDS, are examples of
agents that have been approved under “accelerated approval” provisions.
We believe that use of PMX-30063 as an antibiotic would address an unmet medical need; however,
there can be no assurance that the FDA will grant any of our antibiotic product candidate compounds
any of these designations. If a compound is granted one of these designations, it may help to
abbreviate the size and scope of the trials required for submission and approval of an NDA and may
help shorten the review time of any such filing. Each of the last three antibiotic drugs that
targeted MRSA drug resistant Staph infections, one of the anticipated clinical targets of
PMX-30063, and applied to be granted “fast track” status received such status. However, our novel
mechanism-of-action may cause our compounds to be denied such accelerated development and/or review
status. See the section entitled “Risk Factors” for a further discussion of the risks associated
with our intention to apply for such accelerated development and/or review status.
If PMX-30063 is not granted accelerated approval status, we estimate that it will cost at least $50
million in direct development costs over 36-42 months to file an NDA for this product candidate. In
the event that we are granted “fast track,”“priority review” or “accelerated development” status
by the FDA, it is possible that both the time and cost to file an NDA could be significantly less
than these estimates. The exact extent of these potential time and cost savings can only be
determined based on future discussions with the FDA. If we were to secure additional financing and
develop our ophthalmic topical and non-absorbed oral antibiotic product candidates, we estimate
that it will cost at least an additional $35 million in direct development costs over 48-60 months
to file an NDA for each of these
products.
In April 2004, we received a Small Business Innovation Research, or SBIR, grant of $238,000 from
the National Institute of Health (NIH) to conduct animal testing of our product candidates.
Research under this grant was completed and, in March 2006, we received a Phase II SBIR grant of
$2.9 million over three years in support of our development of an i.v. antibiotic product
candidate.
Heptagonist Product Candidate
UFH and LMWH are blood clot prevention drugs, which are commonly used in numerous post-surgical
applications as anti-coagulants. Overdoses of UFH or LMWH are dangerous due to potentially
life-threatening bleeding. While widely used, UFH and LMWH have the risk of adverse bleeding side
effects, which requires frequent monitoring.
Market Opportunity
Unfractionated Heparin (UFH)
Protamine is the only available reversing agent for UFH. It is used both as an antidote in the
event of overdose, and more commonly in standard treatment as a reversing agent following coronary
artery bypass grafts (CABG, or “bypass” procedures), in which standard practice involves
administering UFH while the patient is on the heart-lung bypass machine to prevent blood clots from
forming in the machine and which could then cause problems when the blood is re-infused to the
patient. However, protamine has many significant potential adverse effects, including:
Ø
unpredictable efficacy, resulting in variable inter-patient activity;
Ø
anticoagulant activity of protamine can actually increase and worsen the anticoagulant
activity of UFH, and which requires complex dose-titration and careful administration of
often several doses;
Ø
allergic anaphylactic reactions in some patients due to the fact that protamine is a
biological product derived from fish sperm;
Ø
inferior fibrokinetics, or clot formation, can result in leaky clots and in more serious
cases rebound bleeding may occur; and
Ø
immunogenic reactions with antibodies formed after sensitization to protamine in
patients who have previously received protamine can impact efficacy and result in severe
reaction; some patients, such as diabetic patients receiving zinc insulin, or males who
have undergone vasectomy, may have pre-existing antibodies that could pre-dispose them to
sensitivity to protamine.
As a result, we believe there is a significant medical and market need for a safer UFH antagonist.
Worldwide, we estimate approximately two million extracorporeal blood procedures, including
cardiothoracic procedures, are performed that utilize heparin and may require UFH reversal, and
eight million doses of protamine are used annually (IMS data). We believe our hepatagonists will be
a safer alternative to protamine.
Low Molecular Weight Heparin (LMWH)
The LMWHs are often used for longer term prevention of blood clots (thrombophylaxis), in
indications such as deep vein thrombosis (DVT), in patients who have had heart attacks (post MI),
and in cancer patients. All of these patient groups are at risk of developing potentially
life-threatening blood clots, and are given anti-clotting drugs including LMWHs to prevent
dangerous clot formation. Because of their benefits, LMWHs are being increasingly used, with
worldwide sales of approximately $4 Billion in 2005 (according to IMS/RDN Insight), and we estimate
are used by approximately 12 million patients annually.
While having favorable risk/benefit characteristics, a number of clinical studies have shown that
there is a significant incidence of bleeding in patients who receive LMWHs. Most studies generally
show that 1%-4% of patients experience serious, life-threatening bleeding, and up to 20% may
experience clinically significant bleeding. Protamine is not considered reliably effective and is
not approved for reversal of LMWH. In patients who experience bleeding problems while on LMWH,
current care may involve hospitalization, blood transfusions, and surgery, which can be expensive
and unreliable.
LMWHs are not currently used in acute surgical settings, such as cardiothoracic procedures, because
of the lack of a reversing agent. The long half-life of LMWH products of up to 24 hours, while an
advantage for longer-term administration, can be a major disadvantage if a patient has a major
bleeding episode or must be re-operated on shortly after surgery. If clotting time is prolonged due
to systemic LMWH, re-operation may not be possible. Although protamine is available as an antidote
for UFH, it does not work well with LMWH and there currently are no antidotes for LMWH on the
market. The availability of an antidote to LMWH could allow these drugs to be used in
cardiothoracic surgical procedures, as well as used in patients who are currently contraindicated
for LMWH or who may need to undergo re-operation. Thus, an LMWH antagonist could substantially
increase the market and sales of LMWH drugs, thereby also increasing the need and market for a LMWH
antagonist such as out heptagonist product candidate.
For these reasons, we believe there is an important medical need and a significant commercial
opportunity for a LMWH antagonist. A LMWH antagonist could also increase the market and sales of
LMWH drugs.
Product Opportunity
We believe that an antagonist to UFH and LMWH is an attractive product opportunity for the
following reasons:
Ø
Unmet medical need. We believe that a safer antagonist to UFH and an effective and safe
antagonist for LMWH would address a large unmet medical need.
Ø
Ease of clinical trials. The reversal of the blood clotting effects of UFH and LMWH
provides an effective and easily measured end point for human trials.
Ø
Attractive companion product for an LMWH. An LMWH-antagonist offers the possibility to
increase market share of a proprietary brand of LMWH and also provide significant
differentiating advantages versus other LMWH products without a companion antagonist.
Ø
Predictive preclinical models. The method and laboratory measurement of clotting time in
animals is identical to the methodology needed in human clinical trials and should be
predictive of efficacy.
Ø
Pricing. If our product candidates are approved by the U.S. Food and Drug
Administration, or FDA, and marketed, we believe that such products would have reasonable
cost of goods and attractive gross margins.
Ø
Focused acute care markets. Use of UFH and LMWH is concentrated in hospitals, which
could be addressed by a small sales force.
Our Approach
UFH and LMWH are composed of sulfated polysaccharides, which provide an attractive target for the
structure based design of novel molecules. Based on a model for the three-dimensional structure of
these molecules, we have produced a series of compounds that bind very tightly to the critical
pentasaccharide site found on both UFH and LMWH. In preclinical experiments, our compounds have
demonstrated efficacy at sub-micromolar concentrations, and the ability to reverse the effect of
both UFH and LMWH in whole human blood. Furthermore, we believe these compounds function with a
high degree of specificity. We have synthesized and screened a number of compounds that demonstrate
reversal of both UFH and LMWH resulting in the normalization of blood clotting time.
Our objectives in this program are to develop a product that:
Ø
is as effective as protamine in reversing the anticoagulant effect UFH,
Ø
is safer than protamine,
Ø
is easy to use,
Ø
has superior fibrokinetic activity (less deleterious impact on clot formation than protamine),
Ø
is less sensitizing than protamine, and
Ø
is effective in reversing the anticoagulant effect of LMWH.
We believe that a heptagonist with these attributes could replace protamine for its current uses,
expand the heparin reversal market by introducing a reversing agent for LMWH, provide a new
treatment for patients receiving LMWH and who experience bleeding complications and require
reversal, and further expand the LMWH market by allowing physicians to more widely use LMWH.
Preclinical Experiments
One laboratory model used to evaluate the activity of an antagonist to a blood clot prevention drug
(UFH or LMWH) is the measurement of time it takes for blood or plasma to clot, with and without
antagonist (PMX-60056), in the presence of the blood clot prevention drug. PMX-60056 was able to
neutralize the activity of both UFH and LMWH products, as measured by normalization of clotting
time or normalization of various enzyme activities involved in clot formation. For example, in one
experiment normal untreated blood required 28 seconds to clot. When UFH was added to the human
plasma, clotting time increased to more than 300 seconds. When PMX-60056 was added to plasma that
had been treated with UFH, the clotting time was normalized. PMX-60056 was also able to neutralize
UFH in whole human blood. Normalization of clotting time with PMX-60056 occurred at similar
concentrations as that for protamine, indicating comparable potencies for antagonism of UFH in
human plasma and blood between PMX-60056 and protamine. PMX-60056 also effectively reversed the
anti-coagulant activities of several different clinical preparations of LMWH in human plasma or
whole blood.
PMX-60056 has been shown to have distinct advantages over protamine in two safety and
efficacy-related assays. Protamine significantly impaired the aggregation of platelets (necessary
for normal clot formation) whereas PMX-60056 had little effect on platelet aggregation.
Furthermore, when PMX-60056 reversed the effects of UFH or LMWH it also restored the normal rate
and extent of clot formation. However, when protamine was used to reverse UFH or the LMWHs, normal
rates and extent of clot formation were not achieved. In the selection of a safe and effective
compound to control and prevent bleeding in the presence of an anti-coagulant, we believe that
platelet aggregation and restoration of normal clot formation are critically important factors for
choosing the preferred agent.
PMX-60056 rapidly restored normal clotting time in UFH-treated rats and dogs. For example, when
rats were administered UFH at an i.v. dose of 75 U/kg, clotting time was >120 seconds.
Treatment with PMX-60056 after UFH administration restored clotting time to normal (approximately
12-15 seconds) within 1 minute after PMX-60056 treatment at an i.v. dose of 2 mg/kg. In other
experiments with UFH-treated rats, normal clotting time was rapidly restored at i.v. dosages of 0.5
and 1.0 mg/kg of PMX-60056. In dogs treated with 300 U/kg UFH, clotting time was >120 seconds.
Treatment with an i.v. dose of 4 mg/kg PMX-60056 restored normal clotting time by the first time
point examined, which was 5 minutes after compound administration.
We believe that the safety of PMX-60056 may be supported using in vitro hemolysis assays where the
sensitivity, or lysis, of human erythrocytes (red blood cells) was examined in the presence of
increasing concentrations of PMX-60056. In these assays, PMX-60056 was not hemolytic at
concentrations that far exceed the expected therapeutic levels. Single dose toxicity studies in
mice demonstrated that PMX-60056 was well tolerated, indicating that an effective therapeutic
index, which measures the difference between effective doses and toxic doses, may be achieved.
Other safety studies measuring hemodynamic effects (heart rate and blood pressures) in the rat and
cardiovascular responses (EKG, heart rate and blood pressures) in the dog also indicate that an
effective therapeutic index for PMX-60056 may be achieved.
Development Plan
We are currently working to scale up manufacturing of clinical supplies for our lead heptagonist
compound, PMX-60056, under GMP conditions. GLP compliant toxicology, safety pharmacology and
genotoxicity studies have been completed, which indicate that an effective therapeutic index for
PMX-60056 may be achieved. We expect to file an IND (or foreign equivalent) for PMX-60056 and, with
additional financing, expect to commence Phase I human clinical trials during the second quarter of
2008. The Phase I studies will include (i) a study of healthy volunteers receiving PMX-60056 at
various dose levels (Phase 1A) and (ii) a study of heparinized healthy volunteers who receive
PMX-60056 at various dose levels (Phase 1B). While the primary endpoint for the two Phase 1
studies will be a safety assessment, we will be able to gather efficacy data in the Phase 1B study.
We plan to complete the Phase 1A study in the third quarter of 2008 and plan to complete the Phase
1B study in the fourth quarter of 2008. Phase II studies are planned for 2009. If adequate
financing is not secured during the first half of 2008, we will delay or scale-back this program
until additional funding is secured. We estimate that it will cost at least $50 million in
direct clinical development costs over 36-42 months to file a NDA for this product.
In October 2007, we received a Small Business Innovation Research, or SBIR, grant of $100,000 from
the National Institute of Health (NIH) to support the development of biomimetic compounds, such as
PMX-60056, as anti-coagulant antagonists.
PRECLINICAL PROGRAMS:
Defensin Mimetic Antibiotics
In order to achieve the best balance of financial rate of return with risk and timing to market, we
also intend to conduct pre-clinical development of PMX-30063 and other defensin mimetic antibiotic
compounds for both topical and oral antibiotic applications. The initial topical application we are
pursuing is an ophthalmic topical antibiotic for the treatment of eye infections, and the initial
oral application is a non-absorbed oral antibiotic for the treatment of gastrointestinal infections
such as Clostridium difficile. Pending securing additional financing, we hope to advance
pre-clinical development and file additional INDs for the ophthalmic topical and non-absorbed oral
antibiotic indications in the future.
We are also evaluating our defensin mimetic antibiotic compounds for a number of other topical
applications, including topical antibiotic use for skin structure infections, oral healthcare
applications for treatment of periodontal disease, a type of gum disease, topical treatment for ear
infections, topical treatment of fungal infections, topical treatment of acne, and a variety of
non-therapeutic applications in personal care and materials applications.
Medical Device, Industrial and Consumer Applications
We have conducted preliminary experiments which demonstrate that polymer derivatives of our
compounds, such as PMX-50003 and PMX-50001, which we refer to as our antimicrobial polymers, may be
used as effective antimicrobial agents as additives to materials. In one experiment, we coated
glass slides with a polyurethane plastic film. One of our antimicrobial polymers (0.1%
concentration) was then infiltrated into the polyurethane material using solvent and dried. The
slides were placed in a bacteria-rich nutrient broth for 72 hours to ascertain growth of bacterial
colonies on the submerged surfaces. After 72 hours, uncoated glass slides and slides coated with
polyurethane alone were covered with many bacterial colonies. In contrast, slides coated with
polyurethane film containing our antimicrobial polymer showed no bacterial growth.
Similar experiments have been performed in which solid polyurethane plastic disks were created with
one of our antimicrobial polymers directly mixed into the polyurethane plastic matrix. These disks
were then immersed in bacteria-rich broth for 24 hours. After 24 hours, plain polyurethane plastic
disks were covered with bacteria, whereas disks incorporating our polymer were devoid of bacterial
growth. When the disks treated with our antimicrobial polymer were stored at room temperature for
up to 45 days either dry or submerged in a large excess of water, there was little to no loss of
antibacterial activity. Experiments employing longer storage times are now being conducted to
determine the stability of the polymer-formulated plastics under a variety of environmental
conditions. When our polymers are incorporated into the plastic of intravenous catheter tubing and
exposed to a high inoculum of bacteria, significant anti-bacterial activity is observed with the
polymer-derivatized catheter plastic but not with the untreated catheter plastic.
Based on these and other preliminary experiments, we believe that our antimicrobial polymers can
effectively be used as additives to materials, such as various medical devices to prevent certain
healthcare-acquired infection. Additionally, they may be added to paint, plastic or ceramic
materials to create a self-sterilizing environment against certain bacteria in hospitals or other
areas that may benefit from a clean, bacterial resistant environment.
Another potential application of our antimicrobial polymers is to combat Stachybotrys chartarum, or
Black Mold, that causes significant household and commercial building damage in the U.S. Several of
our compounds have shown potent activity against Black Mold as well as other problematic
environmental molds. Polymers can be used as additives to paints, drywall, and other construction
materials to prevent growth of this troublesome and unhealthy fungus.
We do not currently plan to conduct advanced development of any medical device, industrial or
consumer application of our antimicrobial polymers. We intend to focus on generating a limited core
of basic enabling data to
support our efforts to license our antimicrobial polymers to out-licensing partners who will
continue research and development efforts in developing marketable products. We intend to pursue
these out-licensing opportunities with minimal use of our resources. Our antimicrobial polymers and
the out-licensing opportunities they present serve as a possible avenue to accelerate revenue
generation, thereby helping us to fund development of our more advanced product candidates,
including PMX-60056 and PMX-30063.
Biodefense
In recent years, improving our nation’s defense against bioterrorism has become an increasingly
important task. The Department of Homeland Security Appropriation Act signed by President Bush in
October 2003 includes $5.6 billion for medical countermeasures against bioterrorism threats. One of
the major components of spending is focused on the development of antibiotic compounds to treat
biowarfare agents, including the highly infectious bacteria that cause anthrax, tularemia and
plague.
Antibiotic activity against anthrax and other biowarfare pathogens, with a mechanism by which
resistance is unlikely to develop, has commercial, medical and national security value. Preliminary
data from our preclinical experiments indicates that our product candidates have potent activity
against biowarfare agents that cause anthrax, tularemia and plague.
As a result of this preliminary data, we are pursuing funding from government sources, such as the
Department of Defense, the Defense Advanced Research Projects Agency and other military and
security agencies to further test and advance our product candidates for indications important to
national security. In November 2004, we received a Phase I SBIR grant of $168,000 to support
preliminary research in the biodefense area. In February 2008, we received notice that we are to be
awarded a grant of $1.6 million for Initiative for Defense Against Bio-Warfare and Bio-Terrorism
from the Department of Defense.
Antifungal Agents
Our compounds have demonstrated promising activity against fungus strains that often cause human
infectious diseases. In preclinical experiments, certain of our compounds have demonstrated
effectiveness at inhibiting fungal growth and, for certain strains of fungus, effectiveness was
achieved at lower concentrations than that of Fluconazole, a commonly used antifungal agent. We
intend to continue to investigate the potential of our compounds as novel treatments for human
fungal infections.
Angiogenesis Inhibitor
Our angiogenesis inhibitor compounds, such as PMX-20005, have demonstrated promising activity in in
vitro and animal models of inhibition of angiogenesis, the abnormal growth of blood vessels. An
angiogenesis inhibitor may be effective in treating age related macular degeneration (or AMD); a
common form of blindness caused by excessive and abnormal growth of blood vessels inn the back of
the eye. If additional financing is secured, we hope to continue to investigate the potential of
our compounds as novel treatments of AMD and other angiogenesis related diseases.
Our Strategy
Our goal is to discover and develop novel agents for the treatment of serious infectious diseases
and cardiovascular disorders using biomimetics. To achieve this objective, we are implementing the
following strategies:
Identify and Advance the Development of our Lead Product Candidates. We believe our current
financial resources provide us with sufficient funding to support the continued development of two
programs: PMX-30063 as our i.v. antibiotic product candidate and PMX-60056 as our heptagonist
product candidate. Additionally, contract development is continuing for antimicrobial polymers. To
advance these and other programs into clinical development, we will require additional financing
and financial resources.
Retain Rights to Market Hospital-Based Products to Hospitals in North America. We have exclusive
commercial rights to all of our programs. Our objective is to generate maximum value from sales of
our product candidates if regulatory approval is achieved. To achieve this goal, we intend to build
our own specialty sales force to market hospital-based therapeutics, such as PMX-30063 and
PMX-60056, to hospitals in North America. Additionally, we
plan to collaborate with third parties to commercialize our products in the primary care markets
and in international markets.
Pursue Near-Term Revenue Opportunities through Out-Licensing and Partnership Agreements. We intend
to out-license selected product candidates from internal programs that are not part of our
strategic focus. For example, polymer derivatives of our antibiotic product candidates may be used
as additives to medical device, industrial and consumer materials to create self-sterilizing
surfaces and bactericidal products. In the future, we intend to pursue strategic alliances with
leading pharmaceutical and biotechnology companies to design biomimetic compounds for targets
selected by our partners. Such collaborations could generate multiple sources of revenue, such as
up-front fees, research funding, milestone payments and royalties.
Utilize our Technology to Aggressively Pursue Additional Drug Development Programs for Other
Therapeutic Areas. Using our computational drug design tools, we have already identified potential
product candidates for other therapeutic areas, including angiogenesis inhibitors. As sufficient
resources become available, we plan to pursue development in these areas through partnerships or on
our own in order to expand our product pipeline.
Strengthen Collaborations with Existing Partners and Enter into Agreements with Potential New
Partners. We have entered into collaborations and agreements with leading academic institutions. We
are actively pursuing additional agreements that would provide for license fees, research funding
and milestone payments and royalties from research results and subsequent product development and
commercialization. Through our collaborations with academic institutions, we gain cost effective
access to new technologies and expertise important to the further development of our technology and
products. Our network of academic advisors and collaborators consists of respected experts in
computational chemistry and drug design technology. We have either exclusive ownership rights or
options to obtain exclusive license rights to any products that result from our academic
relationships.
Research and Development
We incurred research and development expenses of $9,328,000, $3,306,000 and $2,526,000 for the
years ended December 31, 2007, 2006 and 2005, respectively.
Proprietary Rights
University of Pennsylvania
In January 2003, we entered into a Patent License Agreement with the University of Pennsylvania, or
Penn. Under the terms of the agreement, we were granted an exclusive, worldwide royalty-bearing
license to use, make and sell products utilizing seven of Penn’s issued patents or pending patent
applications for the life of such patents. These patents and applications cover compounds that we
are currently using to develop our i.v. antibiotic product candidate, our heptagonist product
candidate, our oral antibiotic product candidates, and our antimicrobial polymers for biomaterials
applications, as well as future product candidates utilizing the licensed patents and applications.
The licensed patents and applications include:
Ø
two issued U.S. patents and four pending U.S. patent applications covering the
composition of matter on antimicrobial compounds, including small molecules, oligomers and
polymers. The first issued patent expires in 2017, the second issued patent expires in
2022, and the other patents, if issued, will expire at varying times from 2022 to 2025.
There are corresponding foreign applications to one of the issued U.S. patents and to each
of the four pending U.S. patent applications.
Ø
one U.S. patent application and two corresponding foreign patent applications covering
polycationic compounds and their use for treating cancer. The patent, if issued, will
expire in 2026.
Penn may terminate the licenses if:
Ø
we are more than 60 days late in paying to Penn royalties, expenses, or any other
undisputed amounts due under the agreement and we do not pay such amounts within 30 days’
written notice of such delinquency;
Ø
we become insolvent, enter into bankruptcy or a similar proceeding or call a meeting of
our creditors in order to arrange adjustment of our debts; or
If this license agreement is properly terminated by Penn, we may not be able to execute our
strategy to develop and commercialize our i.v. antibiotic product candidate, our heptagonist
product candidate, our oral antibiotic product candidates, our antimicrobial polymers for
biomaterials applications, or to develop and commercialize future product candidates utilizing the
licensed patents.
We also entered into a Software License Agreement with Penn in May 2003. Under the terms of the
agreement, Penn granted us a non-exclusive, royalty-free license to use three software programs and
an exclusive, royalty-free license to three patent applications relating to such software programs.
The software programs and patents covered by the agreement include a suite of proprietary
computational algorithms that we use in the development, refinement and testing of our product
candidates. The licenses expire contemporaneously with our Patent License Agreement with Penn. The
patents relating to the software licenses, if issued, will expire at varying times in 2023 and
2024. Penn may terminate the agreement if:
Ø
we are more than 60 days late in paying to Penn any undisputed amounts due under the
agreement and we do not pay such amounts within 30 days’ written notice of such
delinquency;
Ø
we become insolvent, enter into bankruptcy or a similar proceeding or call a meeting of
our creditors in order to arrange adjustment of our debts; or
Ø
we otherwise materially breach the agreement.
If this license agreement is properly terminated by Penn, our ability to advance our current
product candidates or develop new product candidates may be adversely affected.
We also sponsor certain research by Dr. William DeGrado, a Professor of Biochemistry and Biophysics
at Penn. Any discoveries made under this arrangement are intended to be covered by our Patent
License Agreement with Penn or a new license agreement with Penn containing substantially the same
terms. Dr. DeGrado’s current research for us focuses on further development of our antimicrobial
and hepatagonists applications. For these services, we pay Dr. DeGrado a consulting fee of $7,000
per month. Dr. DeGrado also serves as Chairman of our Scientific Advisory Board. Either we or Dr.
DeGrado may terminate his consulting arrangement at any time. If Dr. DeGrado terminates his
consulting arrangement, our ability to advance our antimicrobial and hepatagonists programs may be
adversely affected.
University of Massachusetts
In January 2004, we entered into a Sponsored Research Agreement with the University of
Massachusetts, or UMass. Under the terms of this agreement, as amended, we have agreed to sponsor
certain research of Dr. Gregory Tew, an Assistant Professor in the Polymer Science and Engineering
Department at UMass, through March 2008, and have the exclusive option to license any intellectual
property generated by such research. We may exercise this option by issuing 7,500 shares of our
common stock to UMass for each $100,000 of research conducted by Dr. Tew. During 2007, we issued
12,500 shares to UMass in connection with this agreement. Dr. Tew’s research focuses on methods to
add our antibiotic agents to biomaterials, testing the physical properties of our antibiotic agents
and safety evaluation of our antimicrobial agents. The agreement will terminate if Dr. Tew leaves
UMass or ceases work in the antimicrobial field of research. In addition, UMass may terminate the
agreement including any licenses granted thereunder if we materially breach the agreement,
including by nonpayment of amounts due under the agreement. If the Sponsored Research Agreement or
any license thereunder is properly terminated by UMass, our ability to advance our antimicrobial
program or develop new product candidates may be adversely affected.
In January 2005, we entered into an Exclusive License Agreement with UMass, pursuant to which UMass
granted us an exclusive, worldwide license to use, make and sell products under one U.S. patent
application and seven corresponding foreign patent applications covering polynorborene co-polymers
and methods of use for the life of such patents. The patents, if issued, will expire in 2025. UMass
may terminate the license agreement if we materially breach the agreement, including by nonpayment
of amounts due under the agreement or in the case of a change in our ownership or control. If the
license agreement is properly terminated by UMass, we may not be able to execute our strategy to
develop and commercialize our antimicrobial polymers for biomaterials applications or to develop
and commercialize future product candidates utilizing the licensed patents.
We initiate the design our product candidates using our proprietary computational drug design
technology. There are several computational methods used to assist the drug design process, which
includes the capabilities to:
Ø
the ability to model molecular interactions in the presence of solvent, such as an
aqueous environment, rather than in a vacuum, which more closely resembles the real-life
characteristics of how molecules interact with each other;
Ø
the ability to simulate molecular interactions for hundreds of microseconds which are
time frames much longer than possible with previous molecular dynamics technologies; and
Ø
the ability to design compounds which target the bacterial cell membrane, instead of a
biochemical cell target.
Our innovative and proprietary de novo drug design approach starts with protein targets with
well-understood physical structures and biological activity, and designs small molecule compounds
that mimic or regulate the activity of these targets. This biomimetic approach of regulating
biological activities by mimicking nature itself with synthetic small molecule compounds allows us
to rationally design novel product candidates and we believe greatly improve the efficiency of new
drug discovery.
Intellectual Property
We rely on a combination of patents and trade secrets, as well as confidentiality and non-use
agreements to protect our intellectual property. Our patent strategy is designed to facilitate
commercialization of our current and future product candidates; and create barriers to entry. Our
intellectual property portfolio currently consists of two patent applications (U.S. and foreign)
owned by us, two issued U.S. patents we exclusively license from Penn and eight U.S. patent
applications we exclusively licensed from Penn and/or UMass (as well as foreign counterparts
thereof). Our patent applications and the ten issued patents and pending patent applications we
exclusively license from Penn and/or UMass include:
Ø
seven U.S. patent applications that have been filed (as well as foreign counterparts
thereof) covering the composition of matter on 11 classes of antimicrobial compounds,
including small molecules, oligomers and polymers. Two U.S. patent have been granted on two
of these applications;
Ø
one patent application covering the use of claimed oligomers for treating ophthalmic and
otic infections;
Ø
one patent application covering the combination of claimed compounds and polymers with
sesquiterpenoid enhancing agents
Ø
one patent application covering novel angiogenesis inhibitors with a wide range of therapeutic uses;
Ø
one patent application covering use of claimed oligomers for treating cancer; and
Ø
three patent applications covering our proprietary, computational algorithms and models,
such as the coarse grain model and a new force field. These patent applications do not
disclose the specific computer code, which will either be copyrighted or kept as a
proprietary trade secret.
Our intellectual property portfolio will be expanded to include additional filings of both
composition of matter and method of use patent applications. A number of new patent applications
are currently in process.
We attempt to protect our trade secrets by entering into confidentiality agreements with third
parties, employees and consultants. Our employees and consultants also sign agreements requiring
that they assign to us their interests in patents and other intellectual property arising from
their work for us. All employees sign an agreement not to engage in any conflicting employment or
activity during their employment with us and not to disclose or misuse confidential information.
In addition, we have applied for trademark protection for “PolyMedix” and “PolyDentix”.
The pharmaceutical industry is highly competitive. We face significant competition from
pharmaceutical companies and biotechnology companies that are researching and selling products
designed to treat bacterial infections. Many major pharmaceutical companies, such as
GlaxoSmithKline, Pfizer, Bayer, Merck and Sanofi Aventis have already established significant
positions in the antibiotic market. Additionally, many smaller companies, such as Cubist
Pharmaceuticals, Oscient Therapeutics, Ceragenix, NovaBay Pharmaceuticals, Inc. and Inhibitex have
either marketed antibiotics and/or are attempting to enter this market by developing novel and more
potent antibiotics that are intended to be effective against drug-resistant bacterial strains.
These companies, as well as potential entrants into the antibiotic market, have longer operating
histories, larger customer or use bases, greater brand recognition and significantly greater
financial, marketing and other resources than we do. Many of these current or potential competitors
can devote substantially greater resources to the development and promotion of their products than
we can.
Additionally, there has been consolidation within the pharmaceutical industry and larger,
well-established and well-financed entities may continue to acquire, invest in or form joint
ventures to gain access to additional technology or products. Any of these trends would increase
the competition we face and could adversely affect our business and operating results.
Heptagonist Product Candidate Competition
There are currently no products available in the marketplace as an antidote for and antagonist to
LWMH, while protamine is the only available antidote for and antagonist to UFH and, as such,
protamine currently dominates this market. Because of protamine’s poor side effect profile, we
believe that our heptagonist products may penetrate into the UFH antagonist market.
Government Regulation
Government authorities in the U.S., at the federal, state, and local level, and foreign countries
extensively regulate, among other things, the following areas relating to our products candidates:
Ø
research and development;
Ø
testing, manufacture, labeling and distribution;
Ø
advertising, promotion, sampling and marketing; and
Ø
import and export.
All of our products require regulatory approval by government agencies prior to commercialization.
In particular, human therapeutic products are subject to rigorous preclinical and clinical trials
to demonstrate safety and efficacy and other approval procedures of the FDA and similar regulatory
authorities in foreign countries. Various federal, state, local, and foreign statutes and
regulations also govern testing, manufacturing, labeling, distribution, storage and record keeping
related to such products and their promotion and marketing. The process of obtaining these
approvals and the compliance with federal, state, local, and foreign statutes and regulations
require the expenditure of substantial time and financial resources. In addition, the current
regulatory and political environment at the FDA could lead to increased testing and data
requirements that could impact regulatory timelines and costs.
None of our product candidates has received marketing approval. All of our product candidates are
in preclinical stages of development.
U.S. Government Regulation
In the U.S., the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act and
implementing regulations. If we fail to comply with the applicable requirements at any time during
the product development process, approval process, or after approval, we may become subject to
administrative or judicial sanctions. These sanctions could include:
Ø
refusal to approve pending applications;
Ø
withdrawals of approvals;
Ø
clinical holds;
Ø
warning letters;
Ø
product recalls and product seizures; and
Ø
total or partial suspension of our operations, injunctions, fines, civil penalties or criminal prosecution.
Any agency enforcement action could have a material adverse effect on us.
Currently there is a substantial amount of congressional and administration review of the FDA and
the regulatory approval process for drug candidates in the U.S. As a result, there may be
significant changes made to the regulatory approval process in the U.S.
The steps required before a drug may be marketed in the U.S. include:
Ø
preclinical laboratory tests, animal studies and formulation studies;
Ø
submission to the FDA of an IND, which must become effective before human clinical
trials may begin;
Ø
execution of adequate and well-controlled clinical trials to establish the safety and
efficacy of the product for each indication for which approval is sought;
Ø
submission to the FDA of an NDA, or biologics license application, or BLA;
Ø
satisfactory completion of an FDA inspection of the manufacturing facility or facilities
at which the product is produced to assess compliance with current good manufacturing
practice, or cGMP; and
Ø
FDA review and approval of the NDA or biologics application, or BLA, or any supplements
thereto, including, if applicable, a determination of its controlled substance schedule.
Preclinical studies generally are conducted in laboratory animals to evaluate the potential safety
and activity of a product. Violation of the FDA’s good laboratory practices regulations can, in
some cases, lead to invalidation of the studies, requiring these studies to be replicated. In the
U.S., drug developers submit the results of preclinical trials, together with manufacturing
information and analytical and stability data, to the FDA as part of the IND, which must become
effective before clinical trials can begin in the U.S. An IND becomes effective 30 days after
receipt by the FDA unless before that time the FDA raises concerns or questions about the proposed
clinical trials outlined in the IND. In that case, the IND sponsor and the FDA must resolve any
outstanding FDA concerns or questions before clinical trials can proceed. If these concerns or
questions are unresolved, the FDA may not allow the clinical trials to commence.
Clinical trials involve the administration of the investigational product candidate or approved
products to human subjects under the supervision of qualified investigators. Clinical trials are
conducted under protocols detailing, among other things, the objectives of the study, the
parameters to be used in assessing the safety and the effectiveness of the drug. Typically,
clinical evaluation involves a time-consuming and costly three-phase sequential process, but the
phases may overlap. Each trial must be reviewed, approved and conducted under the auspices of an
independent institutional review board, and each trial must include the patient’s informed consent.
The following sets forth a brief description of the typical phases of clinical trials:
Phase
I
Refers typically to closely monitored clinical trials and includes the initial
introduction of an investigational new drug into human patients or healthy volunteer subjects.
Phase I clinical trials are designed to determine the safety, metabolism and pharmacologic
actions of a drug in humans, the potential side effects of the product candidates associated
with increasing drug doses and, if possible, to gain early evidence of the product candidate’s
effectiveness. Phase I trials also include the study of structure-activity relationships and
mechanism-of-action in humans, as well as studies in which investigational drugs are used as
research tools to explore biological phenomena or disease processes. During Phase I clinical
trials, sufficient information about a drug’s pharmacokinetics and pharmacological effects
should be obtained to permit the design of well-controlled, scientifically valid Phase II
studies. The total number of subjects and patients included in Phase I clinical trials varies,
but is
Refers to controlled clinical trials conducted to evaluate appropriate dosage and the
effectiveness of a drug for a particular indication or indications in patients with a disease
or condition under study and to determine the common short-term side effects and risks
associated with the drug. These clinical trials are typically well controlled, closely
monitored and conducted in a relatively small number of patients, usually involving no more
than several hundred subjects. Phase II studies can be sequenced as Phase IIa or Phase IIb.
Phase III
Refers to expanded controlled and uncontrolled clinical trials. These clinical trials
are performed after preliminary evidence suggesting effectiveness of a drug has been obtained.
Phase III clinical trials are intended to gather additional information about the
effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of
the drug and to provide an adequate basis for physician labeling. Phase III trials usually
include from several hundred to several thousand subjects.
Phase IV
Refers to trials conducted after approval of a new drug and which explore approved uses
and approved doses of the product. These trials must also be approved and conducted under the
auspices of an institutional review board. Phase IV studies may be required as a condition of
approval.
Clinical testing may not be completed successfully within any specified time period, if at all. The
FDA closely monitors the progress of each of the first three phases of clinical trials that are
conducted in the U.S. and may, at its discretion, reevaluate, alter, suspend or terminate the
testing based upon the data accumulated to that point and the FDA’s assessment of the risk/benefit
ratio to the patient. The FDA can also provide specific guidance on the acceptability of protocol
design for clinical trials. The FDA or we may suspend or terminate clinical trials at any time for
various reasons, including a finding that the subjects or patients are being exposed to an
unacceptable health risk. The FDA can also request additional clinical trials be conducted as a
condition to product approval. During all clinical trials, physicians monitor the patients to
determine effectiveness and to observe and report any reactions or other safety risks that may
result from use of the drug candidate.
Assuming successful completion of the required clinical trial, drug developers submit the results
of preclinical studies and clinical trials, together with other detailed information including
information on the chemistry, manufacture and control of the product, to the FDA, in the form of an
NDA or BLA, requesting approval to market the product for one or more indications. In most cases,
the NDA/BLA must be accompanied by a substantial user fee. The FDA reviews an NDA/BLA to determine,
among other things, whether a product is safe and effective for its intended use.
Before approving an application, the FDA will inspect the facility or facilities where the product
is manufactured. The FDA will not approve the application unless cGMP compliance is satisfactory.
The FDA will issue an approval letter if it determines that the application, manufacturing process
and manufacturing facilities are acceptable. If the FDA determines that the application,
manufacturing process or manufacturing facilities are not acceptable, it will outline the
deficiencies in the submission and will often request additional testing or information.
Notwithstanding the submission of any requested additional information, the FDA ultimately may
decide that the application does not satisfy the regulatory criteria for approval and refuse to
approve the application by issuing a “not approvable” letter.
The testing and approval process requires substantial time, effort and financial resources, which
may take several years to complete. The FDA may not grant approval on a timely basis, or at all. We
may encounter difficulties or unanticipated costs in our efforts to secure necessary governmental
approvals, which could delay or preclude us from marketing our products. Furthermore, the FDA may
prevent a drug developer from marketing a product under a label for its desired indications or
place other conditions, including restrictive labeling, on distribution as a condition of any
approvals, which may impair commercialization of the product. After approval, some types of changes
to the approved product, such as adding new indications, manufacturing changes and additional
labeling claims, are subject to further FDA review and approval.
If the FDA approves the NDA/BLA, the drug can be marketed to physicians to prescribe in the U.S.
After approval, the drug developer must comply with a number of post-approval requirements,
including delivering periodic reports to the FDA (i.e., annual reports), submitting descriptions of
any adverse reactions reported, biological product deviation reporting, and complying with drug
sampling and distribution requirements. The holder of an approved
NDA/BLA is required to provide updated safety and efficacy information and to comply with
requirements concerning advertising and promotional labeling. Also, quality control and
manufacturing procedures must continue to conform to cGMP after approval. Drug manufacturers and
their subcontractors are required to register their facilities and are subject to periodic
unannounced inspections by the FDA to assess compliance with cGMP, which imposes procedural, and
documentation requirements relating to manufacturing, quality assurance and quality control.
Accordingly, manufacturers must continue to expend time, money and effort in the area of production
and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.
The FDA may require post-market testing and surveillance to monitor the product’s safety or
efficacy, including additional studies to evaluate long-term effects.
In addition to studies requested by the FDA after approval, a drug developer may conduct other
trials and studies to explore use of the approved drug for treatment of new indications, which
require submission of a supplemental or new NDA and FDA approval of the new labeling claims. The
purpose of these trials and studies is to broaden the application and use of the drug and its
acceptance in the medical community.
Foreign Regulation
Whether or not we obtain FDA approval for a product, we must obtain approval of a clinical trial or
product by the comparable regulatory authorities of foreign countries before we can commence
clinical trials or marketing of the product in those countries. The approval process varies from
country to country, and the time may be longer or shorter than that required for FDA approval. The
requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement
also vary greatly from country to country. Although governed by the applicable country’s
regulations, clinical trials conducted outside of the U.S. typically are administered with the
three-phase sequential process that is discussed above under “U.S. Government Regulation.” However,
the foreign equivalent of an IND is generally not a prerequisite to performing pilot studies or
Phase I clinical trials.
Furthermore, regulatory approval of prices is required in most countries other than the U.S. We
face the risk that the resulting prices would be insufficient to generate an acceptable return to
us or our collaborators.
Business History
PolyMedix, Inc. (formerly known as BTHC II Acquisition Corp.) was originally organized in the State
of Texas as BTHC II LLC, a public shell company. On September 29, 2004, BTHC II LLC and its sister
companies filed an amended petition under Chapter 11 of the United States Bankruptcy Code. On
November 22, 2004, the court approved BTHC II LLC’s Amended Plan of Reorganization. On March 24,2005, and in accordance with its Amended Plan of Reorganization, BTHC II LLC changed its state of
organization from Texas to Delaware by merging with and into BTHC II Acquisition Corp., a Delaware
corporation formed solely for the purpose of effecting the reincorporation. After this merger, BTHC
II Acquisition Corp. became the public shell company.
PolyMedix Pharmaceuticals, Inc. (formerly known as PolyMedix, Inc.) was incorporated on August 8,2002 in the State of Delaware as PolyMedix, Inc. to serve as a biotechnology company focused on
treating infectious diseases. On October 6, 2005, the former BTHC II Acquisition Corp. entered into
an Agreement and Plan of Merger and Reorganization with the former PolyMedix, Inc., pursuant to
which the stockholders of the former PolyMedix, Inc. exchanged their equity ownership interests in
the former PolyMedix, Inc. for an aggregate 94% equity ownership interest in the former BTHC II
Acquisition Corp. Pursuant to the Agreement and Plan of Merger and Reorganization, the former
PolyMedix, Inc. merged with a wholly-owned subsidiary of the former BTHC II Acquisition Corp. and,
as such, became a wholly-owned subsidiary of the former BTHC II Acquisition Corp.
At the time of the merger, the former BTHC II Acquisition Corp. had no operations and no assets or
liabilities. Because the stockholders of the former PolyMedix, Inc. exchanged their equity
ownership interests in the former PolyMedix, Inc. for an aggregate 94% equity ownership interest in
the former BTHC II Acquisition Corp., the former PolyMedix, Inc. was, for accounting purposes, the
surviving entity of the merger. Accordingly, all financial information included in this annual
report for the periods prior to the merger is for the former PolyMedix, Inc.
On February 24, 2006, the former BTHC II Acquisition Corp. changed its corporate name to PolyMedix,
Inc., and the former PolyMedix, Inc. changed its corporate name to PolyMedix Pharmaceuticals, Inc.
We currently have 13 employees, including one M.D. and five employees with Ph.D. degrees. Seven of
our employees are focused on research and development and five are focused on general
administration. We also utilize a number of consultants to assist with research and development and
commercialization activities.
Item 1A. Risk Factors.
Risks Related to Our Business
If we are unable to meet our needs for additional funding in the near future, we may be required to
limit, scale-back or cease operations.
Our operations to date have generated significant needs for cash. Our negative cash flows from
operations are expected to continue for at least the foreseeable future. Our strategy contains
elements that we will not be able to execute without outside funding. Specifically, we will need to
raise additional capital to:
Ø
fund our research and development programs, including clinical trials;
Ø
commercialize any product candidates that receive regulatory approval; and
Ø
acquire or in-license approved products or product candidates or technologies for
development.
We plan to sell additional equity securities during the first half of 2008. If we are not able to
raise sufficient capital, we will have to delay, scale-back or eliminate certain research, drug
discovery or development activities or certain other aspects of our operations and as a result our
business may be materially and adversely affected. We did not raise as much additional funding in
2007 as we had planned, and as a result, we scaled-back our pre-clinical research efforts. Our
future capital requirements will depend on many factors, including:
Ø
the scope, rate of progress and cost of our product development activities;
Ø
future clinical trial results;
Ø
the terms and timing of any future collaborative, licensing and other arrangements
that we may establish;
Ø
the cost and timing of regulatory approvals;
Ø
the costs of commercializing any of our other product candidates;
Ø
success of any product that receives marketing approval;
Ø
acquisition or in-licensing costs;
Ø
the effect of competing technological and market developments;
Ø
the cost of filing, prosecuting, defending and enforcing any patent claims and
other intellectual property rights; and
Ø
the extent to which we acquire or invest in businesses, products and technologies,
although we currently have no commitments or agreements relating to any of these types of
transactions.
These factors could result in variations from our currently projected operating and liquidity
requirements. There can be no assurance that additional funds will be available when needed, or, if
available, that such funds can be obtained on terms acceptable to us. If adequate funds are
unavailable, we may be required, among other things, to:
Ø
delay, reduce the scope of or eliminate one or more of our research or development
programs;
Ø
license rights to technologies, product candidates or products at an earlier stage
than otherwise would be desirable or on terms that are less favorable to us than might
otherwise be available; or
Ø
obtain funds through arrangements that may require us to relinquish rights to
product candidates or products that we would otherwise seek to develop or commercialize by
ourselves.
We are a development stage company with limited operating history, which makes it difficult to
evaluate our existing business and business prospects and increases the risk that the value of any
investment in our Company will decline.
We commenced operations in 2002 and have a limited operating history. To date, our only revenues
have been from research grants. We will not be able to generate revenue from product sales or
royalties unless and until we receive regulatory approval and begin commercialization of our
product candidates or otherwise out-license our compounds. We are not certain of when, if ever,
that will occur. Although we intend to introduce new products, there can be no assurance that we
will introduce any new products. Because the market for our products is relatively new, uncertain
and evolving, and because we have limited operating experience, it is difficult to assess or
predict with assurance the growth rate, if any, and the size of this market. There can be no
assurance that we will develop additional products, that the market for our products will develop,
that our products will achieve market acceptance, or that we will ever become profitable.
We have incurred losses since inception and anticipate that we will continue to incur losses for
the foreseeable future.
We are a development stage company with a limited operating history. For the year ended December31, 2007, we had a net loss of approximately $12,164,000 and an accumulated deficit of
approximately $25,873,000. We expect to continue to incur significant and increasing operating
losses, in the aggregate and on a per share basis, for the next several years. These losses, among
other things, have had and will continue to have an adverse effect on our stockholders’ equity, net
current assets and working capital.
Because of the numerous risks and uncertainties associated with developing new drugs, we are unable
to predict the extent of any future losses or when we will become profitable, if at all. Currently,
we have no products available for commercial sale, and, to date, we have not generated any product
revenue. We have financed our operations and internal growth primarily through the sale of equity
securities. We have devoted substantially all of our efforts to research and development, including
GMP manufacturing and GLP compliant toxicology, safety pharmacology and genotoxicity studies for
our clinical product candidates.
We also expect our research and development expenses to increase in connection with the continued
development and human clinical studies of our product candidates. If our product candidates are not
demonstrated to be sufficiently safe and effective in clinical trials, they will not receive
regulatory approval and we will be unable to commercialize them and our business and results of
operations will suffer.
None of our product candidates has received regulatory approval for commercial sale and our product
candidates may never be commercialized. In addition, all of our product candidates are in the early
stages of development, and we face the risks of failure inherent in developing drugs based on new
technologies. We plan to develop our product candidates through studies, testing and clinical
trials. The progress and results of any future clinical trials or future pre-clinical testing are
uncertain, and if our product candidates do not receive regulatory approvals, it will have a
material adverse effect on our business, operating results and financial condition. Our product
candidates are not expected to be commercially available for several years, if at all.
In addition, our product candidates must satisfy rigorous standards of safety and efficacy before
they can be approved by the FDA and/or other foreign regulatory authorities for commercial use. The
FDA and foreign regulatory authorities have full discretion over this approval process. We will
need to conduct significant additional research, involving testing in animals and in humans, before
we can file applications for product approval. Typically, in the pharmaceutical industry there is a
high rate of attrition for product candidates in pre-clinical testing and clinical trials. Also,
satisfaction of regulatory requirements typically takes many years, is dependent upon the type,
complexity and novelty of the product and requires the expenditure of substantial resources.
Success in pre-clinical testing and early clinical trials does not ensure that later clinical
trials will be successful. For example, a number of companies in the pharmaceutical industry,
including biotechnology companies, have suffered significant setbacks in advanced clinical trials,
even after promising results in earlier trials and in interim analyses. In addition, delays or
rejections may be encountered based upon additional government regulation, including any changes in
FDA policy, during the process of product development, clinical trials and regulatory approvals.
In order to receive FDA approval or approval from foreign regulatory authorities to market a
product candidate or to
distribute our products, we must demonstrate through pre-clinical testing and through human
clinical trials that the product candidate is safe and effective for the treatment of a specific
condition. We do not know for certain when, if ever, any human clinical trials will begin with
respect to our product candidates.
If we are not able to retain our current management and advisory team and attract and retain
qualified scientific, technical and business personnel, our business will suffer.
We are highly dependent on our executive officers and other key management and technical personnel,
including Nicholas Landekic, Richard Scott, Ph.D., Eric McAllister, M.D., Ph.D., Edward Smith, Dawn
Eringis and Bozena Korczak, Ph.D., as well as key members of our advisory team, including William
DeGrado, Ph.D., Michael Klein, Ph.D. and Gregory Tew, Ph.D. The loss of any of them could have a
material adverse effect on our future operations. We presently do not maintain “key person” life
insurance policies on any of our personnel.
Our success is also dependent on our ability to attract, retain and motivate highly trained
technical, marketing, sales and management personnel for the development, maintenance and expansion
of our activities. There can be no assurance that we will be able to retain our existing personnel
or attract additional qualified employees. The loss of key personnel or the inability to hire and
retain additional qualified personnel in the future could have a material adverse effect on our
business, financial condition and results of operation.
Our success is dependent on the continuation of certain licensing arrangements and other strategic
relationships with third parties. There can be no assurance that such relationships will continue
or that we will be successful in entering into other similar relationships.
We are newly formed and all of our product candidates are licensed from or based upon licenses from
third parties. We are party to (i) a Patent License Agreement with the University of Pennsylvania,
or Penn, pursuant to which Penn granted us an exclusive, worldwide royalty-bearing license to use,
make and sell products utilizing seven of Penn’s issued or pending patents for the life of such
patents, and (ii) a Software License Agreement with Penn pursuant to which Penn granted us a
non-exclusive, royalty-free license to use three software programs and an exclusive, royalty-free
license to three patent applications relating to such software programs. If either or both of these
license agreements are properly terminated by Penn, pursuant to its termination rights, our ability
to advance our current product candidates or develop new product candidates may be adversely
affected. Specifically, we may not be able to execute our strategy to develop and commercialize our
UFH and LMWH antagonist product candidate, our i.v. antibiotic product candidate, our topical
ophthalmic and oral antibiotic product candidates, and our angiogenesis inhibitor for cancer and
our antimicrobial polymers for biomaterials applications.
Additionally, we are party to an Exclusive License Agreement with the University of Massachusetts,
or UMass, pursuant to which UMass granted us an exclusive, worldwide license to use, make and sell
products utilizing a patent application covering the composition and use of polynorborene
co-polymers for the life of such patent. If this license agreement is properly terminated by UMass,
pursuant to its termination rights, we may not be able to execute our strategy to develop and
commercialize our antimicrobial polymers for biomaterials applications or to develop and
commercialize future product candidates utilizing the licensed patents.
In addition to licensing arrangements, we have entered into a consulting arrangement with Dr.
William DeGrado, a Professor of Biochemistry and Biophysics at Penn, and a Sponsored Research
Agreement with UMass covering the research of Dr. Gregory Tew, an Assistant Professor in the
Polymer Science and Engineering Department at UMass. Either we or Dr. DeGrado may terminate his
consulting arrangement at any time. If Dr. DeGrado terminates his consulting arrangement, our
ability to advance our UFH and LMWH antagonist and antimicrobial programs may be adversely
affected. If the Sponsored Research Agreement or any license thereunder is properly terminated by
UMass, our ability to advance our antimicrobial program or develop new product candidates may be
adversely affected.
We depend, and will continue to depend, on these arrangements, and potentially on other licensing
arrangements and/or strategic relationships with third parties for the research, development,
manufacturing and commercialization of our product candidates. If any of our licenses or
relationships are terminated or breached, we may:
Ø
lose our rights to develop and market our product candidates;
Ø
lose patent and/or trade secret protection for our product candidates;
Ø
experience significant delays in the development or commercialization of our
product candidates;
Ø
not be able to obtain any other licenses on acceptable terms, if at all; and
Licensing arrangements and strategic relationships in the pharmaceutical and biotechnology
industries can be very complex, particularly with respect to intellectual property rights. Disputes
may arise in the future regarding ownership rights to technology developed by or with other
parties. These and other possible disagreements between us and third parties with respect to our
licenses or our strategic relationships could lead to delays in the research, development,
manufacture and commercialization of our product candidates. These third parties may also pursue
alternative technologies or product candidates either on their own or in strategic relationships
with others in direct competition with us. These disputes could also result in litigation or
arbitration, both of which are time-consuming and expensive, and could require significant time and
attention from our management.
Development of our proposed product candidates is a lengthy, expensive and uncertain process, and
we may terminate one or more of our development programs, which may cause our business and results
of operations to suffer.
Our product candidate development program anticipates a significant amount of cash outflow to
support their development. The defensin mimetic antibiotic drug development program is estimated at
approximately $50 million over an approximately 36-42 month period with the NDA filing planned,
assuming adequate additional financing, for 2011. The Heptagonist drug development is estimated at
approximately $50 million over an approximately 36-42 month period with the NDA filing planned,
assuming adequate additional financing, for 2011. These costs are significant given our limited
opportunity for revenue growth over the same period. In addition, there can be no assurance that we
will be able to obtain additional financing to satisfy the costs of the planned product candidate
development or that the product candidate will be approved by the FDA for commercialization.
There can be no assurance that our i.v. antibiotic product candidate or any of our other eligible
product candidates will be granted any of the accelerated development or approval paths by the FDA
and, even if any of our product candidates receive such status, that development of the product
candidate will be accelerated.
We believe that our i.v. antibiotic product candidate, which is a systemic antibiotic drug, may be
eligible for one of the accelerated development or approval paths under FDA procedures, such as
“fast track,”“priority review” or “accelerated approval.” We have not yet applied for any of these
designations for our i.v. antibiotic product candidate or any of our other product candidates.
There can be no assurance that any of our product candidates will receive any such consideration.
If granted, some of these paths may help to abbreviate the size and scope of the trials required
for submission and approval of an NDA and/or to shorten the review time of any such filing. If the
FDA grants any of these designations to any of our product candidates, we may then make an
application with the FDA with respect to any further development program and corresponding
regulatory strategy.
Even in the event that one of our product candidates is designated for “fast track,”“priority
review” or “accelerated approval” status, such a designation does not necessarily mean a faster
development process or regulatory review process or necessarily confer any advantage with respect
to approval compared to conventional FDA procedures. Our accelerated designation status may be
withdrawn by the FDA if the FDA believes that this designation is no longer supported by emerging
data from our clinical development program or for patient safety reasons. Receiving “fast track,”“priority review” or “accelerated approval” status from the FDA does not guarantee that we will
qualify for or be able to take advantage of any accelerated development or approval procedures.
Even if the accelerated development or approval procedures are available to us, depending on the
results of clinical trials, we may elect to follow the more traditional approval processes for
strategic and marketing reasons, since drugs approved under “accelerated approval” procedures may
be more likely to be subjected to post-approval Phase IV clinical studies to provide confirmatory
evidence that they are safe and effective. If we fail to conduct any such required post-approval
studies or if the studies fail to verify that any of our product candidates are safe and effective,
our FDA approval could be revoked. It can be difficult, time-consuming and expensive to enroll
patients in Phase IV clinical trials because physicians and patients are less likely to participate
in a clinical trial to receive a drug that is already commercially available.
Even if regulatory authorities approve our product candidates, they may not be commercially
successful.
Even if regulatory authorities approve our product candidates, they may not be commercially
successful. Our product candidates may not be commercially successful because physicians,
government agencies and other third-party payors may not accept them. Third parties may develop
superior products or have proprietary rights that preclude us from marketing our products. We also
expect that most of our product candidates will be very expensive, if approved. Patient acceptance
of and demand for any product candidates we obtain regulatory approval for, or licenses, will
depend largely on many factors, including but not limited to, the extent, if any, of reimbursement
of drug and treatment costs by government agencies and other third-party payors, pricing, the
safety and effectiveness of alternative products, and the prevalence and severity of side effects
associated with our products.
We do not currently have sales, marketing or distribution capabilities. If we fail to effectively
sell, market and distribute any product candidate for which we receive regulatory approval, our
business and results of operations will suffer.
If we are unable to create sales, marketing and distribution capabilities or enter into agreements
with third parties to perform these functions, we will not be able to successfully commercialize
any of our product candidates that receive regulatory approval in the future. We currently have no
sales, marketing or distribution capabilities. In order to successfully commercialize any of our
product candidates, we must either internally develop sales, marketing and distribution
capabilities or make arrangements with third parties to perform these services.
If we do not develop a marketing and sales force with technical expertise and supporting
distribution capabilities, we will be unable to market any of our products directly. To promote any
of our products through third parties, we will have to locate acceptable third parties for these
functions and enter into agreements with them on acceptable terms and we may not be able to do so.
In addition, any third-party arrangements we are able to enter into may result in lower revenues
than we could have achieved by directly marketing and selling our products.
We may suffer losses from product liability claims if our products cause harm to patients.
Any of our product candidates could cause adverse events to patients, such as immunologic or
allergic reactions. These reactions may not be observed in clinical trials, but may nonetheless
occur after commercialization. If any of these reactions occur, they may render our product
candidates ineffective in some patients and our sales would suffer.
In addition, potential adverse events caused by our product candidates could lead to product
liability lawsuits. If product liability lawsuits are successfully brought against us, we may incur
substantial liabilities and may be required to limit commercialization of our products. Our
business exposes us to potential product liability risks, which are inherent in the testing,
manufacturing, marketing and sale of pharmaceutical products. We may not be able to avoid product
liability claims. Product liability insurance for the pharmaceutical and biotechnology industries
is generally expensive, if available at all. We do not currently have any product liability
insurance. If we are unable to obtain sufficient insurance coverage on reasonable terms or to
otherwise protect against potential product liability claims, we may be unable to commercialize our
product candidates. A successful product liability claim brought against us in excess of our
insurance coverage, if any, may cause us to incur substantial liabilities and, as a result, our
business may fail.
Due to our reliance on third-party manufacturers and suppliers, we may be unable to implement our
manufacturing and supply strategies, which would materially harm our business.
If our current and future licensing, manufacturing and supply strategies are unsuccessful, then we
may be unable to complete any future preclinical or clinical trials and/or commercialize our
product candidates in a timely manner, if at all. Completion of any potential future pre-clinical
trials and commercialization of our product candidates will require access to, or development of,
facilities to manufacture a sufficient supply of our product candidates, or the ability to license
them to other companies to perform these functions. We do not have the resources, facilities or
experience to manufacture our product candidates on our own and do not intend to develop or acquire
facilities for the manufacture of product candidates for pre-clinical trials, clinical trials or
commercial purposes in the foreseeable future. We intend to continue to license technology and/or
rely on contract manufacturers to produce sufficient
quantities of our product candidates necessary for any pre-clinical or clinical testing we
undertake in the future. Such contract manufacturers may be the sole source of production and may
have limited experience at manufacturing, formulating, analyzing, filling and finishing our types
of product candidates.
We also intend to rely on third parties to supply the components that we will need to develop, test
and commercialize all of our product candidates. There may be a limited supply of these components.
We might not be able to enter into agreements that provide us assurance of availability of such
components in the future from any supplier. Our potential suppliers may not be able to adequately
supply us with the components necessary to successfully conduct our pre-clinical and clinical
trials and/or to commercialize our product candidates. If we cannot acquire an acceptable supply of
components to produce our product candidates, we will not be able to complete pre-clinical and
clinical trials and will not be able to commercialize our product candidates.
If we make technology or product acquisitions, we may incur a number of costs, may have integration
difficulties and may experience other risks that could harm our business and results of operations.
We are newly formed and all of our product candidates are licensed from, or based upon technologies
licensed from, third parties. We may acquire and/or license additional product candidates and/or
technologies in the future. Any product candidate or technology we license or acquire will likely
require additional development efforts prior to commercial sale, including extensive clinical
testing and approval by the FDA and applicable foreign regulatory authorities, if any. All product
candidates are prone to risks of failure inherent in technology product development, including the
possibility that the product candidate or product developed based on licensed technology will not
be shown to be sufficiently safe and effective for approval by regulatory authorities. In addition,
we cannot assure you that any product candidate that we develop based on acquired or licensed
technology that is granted regulatory approval will be manufactured or produced economically,
successfully commercialized or widely accepted in the marketplace. Moreover, integrating any newly
acquired product could be expensive and time-consuming. If we cannot effectively manage these
aspects of our business strategy, our business may not succeed.
Furthermore, proposing, negotiating and implementing an economically viable acquisition or license
can be a lengthy, costly and complex process. Other companies, including those with substantially
greater financial, marketing and sales resources, may compete with us for the acquisition or
license of product candidates and/or technologies. We may not be able to acquire the rights to
alternative product candidates and/or technologies on terms that we find acceptable, or at all. Our
failure to acquire or license alternative products and/or technologies could have a material
adverse effect on our business, prospects and financial condition.
Failure to effectively manage our growth may have a material adverse effect on our business,
results of operations and financial condition.
We may not be able to effectively grow and expand our business. Successful implementation of our
business plan will require management of growth, which will result in an increase in the level of
responsibility for management personnel. To manage growth effectively, we will be required to
continue to implement and improve our operating and financial systems and controls to expand, train
and manage our employee base. The management, systems and controls currently in place or to be
implemented may not be adequate for such growth, and the steps taken to hire personnel and to
improve such systems and controls might not be sufficient. If we are unable to manage our growth
effectively, it will have a material adverse effect on our business, results of operations and
financial condition.
We rely on third parties to provide software necessary to the future success of our business.
Currently, we rely on a non-exclusive license from Penn to use, copy, perform, display, distribute,
modify and prepare derivative works based on three software packages, which include a suite of
proprietary computational algorithms that we use in the development, refinement, and testing of our
product candidates. If this license agreement is properly terminated by Penn, our ability to
advance our current product candidates or develop new product candidates may be adversely affected.
In the future, we expect to rely upon the software programs licensed from Penn, as well as software
licensed from other third parties, including software that might be integrated with our internally
developed software and used to perform key functions. If we license such third-party software, it
is likely that certain of these licenses will be for limited terms, can be renewed only by mutual
consent and may be terminated if we breach the terms of the license
and fail to cure the breach within a specified period of time. There can be no assurance that such
licenses will be available to us on commercially reasonable terms, if at all. The loss of or
inability to maintain or obtain licenses on such third party software could result in the
discontinuation of, or delays or reductions in, product shipments unless and until equivalent
technology is identified, licensed and integrated with our software. Any such discontinuation,
delay or reduction would harm our business, results of operations and financial condition. The
third party licenses that we may need to acquire in the future may not be exclusive, and there can
be no assurance that our competitors will not obtain licenses to and utilize such technology in
competition with us. There can be no assurance that the vendors of technology that may need to be
utilized in our products will support the potentially necessary technology in the form needed by
us. In addition, there can be no assurance that financial or other difficulties that may be
experienced by such third-party vendors will not have a material adverse effect upon the
technologies that may be incorporated into our products, or that, if such technologies become
unavailable, we will be able to find suitable alternatives if it in fact needs them. The loss of,
or inability to maintain or obtain, any such software licenses could potentially result in shipment
delays or reductions until equivalent software could be developed, identified, licensed and
integrated, and could harm our business, operating results, and financial condition if we
ultimately need to rely on such software.
Our executive officers, directors and greater than 5% holders have the ability to significantly
influence matters submitted to our stockholders for approval.
Our executive officers, directors and greater than 5% holders, in the aggregate, beneficially own
shares representing approximately 27% of our common stock. Beneficial ownership includes shares
over which an individual or entity has investment or voting power and includes shares that could be
issued upon the exercise of options and warrants within 60 days after the date of determination. On
matters submitted to our stockholders for approval, holders of our common stock are entitled to one
vote per share. If our executive officers and directors choose to act together, they would have
significant influence over all matters submitted to our stockholders for approval, as well as our
management and affairs. For example, these individuals, if they chose to act together, would have
significant influence on the election of directors and approval of any merger, consolidation or
sale of all or substantially all of our assets. This concentration of voting power could delay or
prevent an acquisition of our company on terms that other stockholders may desire.
Risks Related to our Intellectual Property
The obstacles to procurement and enforcement of our intellectual property and proprietary rights
could harm our competitive position by allowing competitors access to our proprietary technology
and to introduce competing products.
We regard our products as proprietary and rely primarily on a combination of patents, trademarks,
copyrights, and trade secrets and other methods to protect our proprietary rights. We maintain
confidentiality agreements with our employees, consultants and current and potential affiliates,
customers and business partners.
If we fail to secure and then enforce patents and other intellectual property rights underlying our
product candidates and technologies, we may be unable to compete effectively. The pharmaceutical
industry places considerable importance on obtaining patent and trade secret protection for new
technologies, products and processes. Our success will depend, in part, on our ability, and the
ability of our licensors, to obtain and to keep protection for our products and technologies under
the patent laws of the U.S. and other countries, so that we can stop others from using our
inventions. Our success also will depend on our ability to prevent others from using our trade
secrets.
Our pending U.S. and foreign patent applications may not issue as patents or may not issue in a
form that will be advantageous to us. If we do not receive patents for these applications or do not
receive adequate protections, our developments will not have any proprietary protection and other
entities will be able to make the products and compete with us. Also, any patents we have obtained
or do obtain may be challenged by reexamination, opposition or other administrative proceeding, or
may be challenged in litigation, and such challenges could result in a determination that the
patent is invalid or unenforceable. In addition, competitors may be able to design alternative
methods or devices that avoid infringement of our patents. To the extent our intellectual property
protection offers inadequate protection, or is found to be invalid, we are exposed to a greater
risk of direct competition. Both the patent application process and the process of managing patent
disputes can be time consuming and expensive and may require significant time and attention from
our management. Furthermore, the laws of some foreign countries
may not protect our intellectual property rights to the same extent as do the laws of the United
States.
In addition, the standards that the United Stated Patent and Trademark Office, or the U.S. PTO,
uses to grant patents can change. Consequently, we may be unable to determine the type and extent
of patent claims that will be issued to us or to our licensors in the future, if any patent claims
are issued at all. In addition, if the U.S. PTO and other patent offices where we file our patent
applications increase the fees associated with filing and prosecuting patent applications we would
incur higher expenses and our intellectual property strategy could be adversely affected.
The confidentiality agreements required of our employees and that we enter into with other parties
may not provide adequate protection for our trade secrets, know-how or other confidential
information or prevent any unauthorized use or disclosure or the unlawful development by others. If
any of our confidential intellectual property is disclosed, our business may suffer. Such
agreements may not be enforceable or may not provide meaningful protection for our trade secrets or
other proprietary information in the event of unauthorized use or disclosure or other breaches of
the agreements, and we may not be able to prevent such unauthorized disclosure. Monitoring
unauthorized disclosure is difficult, and we do not know whether the steps we have taken to prevent
such disclosure are, or will be, adequate.
We may have to engage in costly litigation to enforce or protect our proprietary technology, which
may harm our business, results of operations, financial condition and cash flows.
The pharmaceutical field is characterized by a large number of patent filings involving complex
legal and factual questions, and, therefore, we cannot predict with certainty whether our patents
or in-licensed patents will be enforceable. Additionally, we may not be aware of all of the patents
potentially adverse to our interests that may have been issued to others. Should third parties file
patent applications, or be issued patents, claiming technology also claimed by us in pending
applications, we may be required to participate in interference proceedings in the U.S. PTO to
determine priority of invention. We, or our licensors, also could be required to participate in
interference proceedings involving our issued patents and pending applications of another entity.
In the event a competitor infringes upon our patent or other intellectual property rights,
litigation to enforce our intellectual property rights or to defend our patents against challenge,
even if successful, could be expensive and time consuming and could require significant time and
attention from our management. We may not have sufficient resources to enforce our intellectual
property rights or to defend our patents against challenges from others. If our intellectual
property does not provide adequate protection against our competitors’ products, our competitive
position and business could be adversely affected.
Our commercial success depends significantly on our ability to develop and commercialize our
products without infringing the intellectual property rights of third parties.
Our commercial success will depend, in part, on our not infringing the patents or proprietary
rights of third parties. Third parties that believe we are infringing on their rights could bring
actions against us claiming damages and seeking to enjoin clinical testing, manufacturing and
marketing of the affected product or products.
If we become involved in any litigation, it could consume a substantial portion of our resources,
regardless of the outcome of the litigation. If any of these actions are successful, we could be
required, in addition to any potential liability for damages, to obtain a license to continue to
manufacture or market the affected product, in which case we may be required to pay substantial
royalties or grant cross-licenses to our patents. However, there can be no assurance that any such
license will be available on acceptable terms or at all. Ultimately, we could be prevented from
commercializing a product, or forced to cease some aspect of our business operations, as a result
of patent infringement claims, which would harm our business.
We may enter into licensing agreements with third party intellectual property owners for use of
their property in connection with our products in order to ensure that such third party’s rights
are not infringed upon. Although we are not aware that any of our intended products are materially
infringing the rights of others, there can be no assurance that a claim of infringement will not be
asserted against us or that any such assertion will not result in costly litigation or require us
to obtain a license in order to make, use, or sell our products. There can be no assurance that
third parties will not assert infringement claims against us in the future with respect to current
or future products. Any such claims or litigation, with or without merit, could be costly and a
diversion of management’s attention, which could have a material adverse effect on our business,
operating results and financial
condition. Adverse determinations in such claims or litigation could harm our business, operating
results and financial condition.
We may be unable to protect the intellectual property rights of the third parties from whom we
license certain of our intellectual property or with whom we have entered into other strategic
relationships, which may harm our business.
Certain of our intellectual property are currently licensed from Penn and UMass and, in the future,
we intend to continue to license intellectual property from Penn and UMass and/or other key
strategic partners. With the exception of a software license from Penn, for which Penn retained a
right to use the software for its own use, such license agreements give us exclusive rights for the
commercial exploitation of the patents resulting from the patent applications, subject to certain
provisions of the license agreements. Failure to comply with these provisions could result in the
loss of our rights under these license agreements. Our inability to rely on these patents and
patent applications that are the basis of our technology would have a material adverse effect on
our business.
We are, and will continue to be, reliant upon such third parties to protect their intellectual
property rights to this technology. Such third parties may determine not to protect the
intellectual property rights that we license from them and we may be unable defend such
intellectual property rights on our own or we may have to undertake costly litigation to defend the
intellectual property rights of such third parties. There can be no assurances that we will
continue to have proprietary rights to any of the intellectual property that we license from such
third parties or otherwise have the right to use through similar strategic relationships. Any loss
or limitations on use with respect to our right to use such intellectual property licensed from
third parties or otherwise obtained from third parties with whom we have entered into strategic
relationships could have a material adverse effect on our business, operating results and financial
condition.
Many countries, including certain countries in Europe, have compulsory licensing laws under which a
patent owner may be compelled to grant licenses to third parties. In addition, most countries limit
the enforceability of patents against government agencies or government contractors. In these
countries, the patent owner may be limited to monetary relief and may be unable to enjoin
infringement, which could materially diminish the value of the patent. Compulsory licensing of
life-saving products is also becoming increasingly popular in developing countries, through either
direct legislation or international initiatives. Such compulsory licenses could be extended to
include some of our product candidates, which may limit our potential revenue opportunities.
International patent protection is particularly uncertain, and if we are involved in opposition
proceedings in foreign countries, we may have to expend substantial sums and management resources.
Patent law outside the U.S. is even more uncertain than in the U.S. and is currently undergoing
review and revision in many countries. Further, the laws of some foreign countries may not protect
our intellectual property rights to the same extent as U.S. laws. For example, certain countries do
not grant patent claims that are related to the treatment of humans. We may participate in
opposition proceedings to determine the validity of our foreign patents or our competitors’ foreign
patents, which could result in substantial costs and diversion of our management’s efforts.
Risks Related to our Industry
We may experience delays in obtaining required regulatory approvals in the U.S. to market our
proposed product candidates.
Delays in regulatory approval, limitations in regulatory approval and withdrawals of regulatory
approval may have a negative impact on our results of operations. If we experience significant
delays in testing or approvals, our product development costs, or our ability to license product
candidates, will increase. If the FDA grants regulatory approval of a product, this approval will
be limited to those disease states and conditions for which the product has demonstrated through
clinical trials to be safe and effective. Any product approvals that we receive in the future could
also include significant restrictions on the use or marketing of our products. Product approvals,
if granted, can be withdrawn for failure to comply with regulatory requirements or upon the
occurrence of adverse events following commercial introduction of the products. Failure to comply
with applicable FDA or other applicable regulatory requirements may result in criminal prosecution,
civil penalties, recall or seizure of products, total or partial suspension of production or
injunction, as well as other regulatory action against our product candidates or us. If
approvals are withdrawn for a product, or if a product were seized or recalled, we would be unable
to sell or license that product and our revenues would suffer. In addition, outside the U.S., our
ability to market any of our potential products is contingent upon receiving market application
authorizations from the appropriate regulatory authorities and these foreign regulatory approval
processes include all of the risks associated with the FDA approval process described above.
Before we can commence clinical trials of any of our product candidates, we will need to complete
preclinical research and commercial evaluation and file an IND (or foreign equivalent) with respect
to such product candidate. We cannot provide assurance that we will complete this preclinical
research or file an IND in a timely fashion or at all.
In the U.S., drug developers submit the results of preclinical trials, together with manufacturing
information and analytical and stability data, to the FDA as part of an IND. An IND must become
effective before clinical trials can begin in the U.S. and similar applications are required in
jurisdictions outside of the U.S. In the U.S., an IND becomes effective 30 days after receipt by
the FDA unless before that time the FDA raises concerns or questions about the proposed clinical
trials outlined in the IND. In that case, the IND sponsor and the FDA must resolve any outstanding
FDA concerns or questions before clinical trials can proceed. If these concerns or questions are
unresolved, the FDA may not allow the clinical trials to commence.
We plan to submit INDs for our defensin mimetic i.v. antibiotic and our heptagonist product
candidates during the second quarter of 2008. During 2008, we anticipate spending, depending on the
results of capital raising activities, between $9,000,000 and $16,000,000 in combined research,
development and general and administrative costs. The filing of IND, or equivalent foreign
applications, and the completion of GMP manufacturing of clinical supplies and Phase I clinical
trials could be delayed or prevented for a variety of reasons, and we can provide no assurance that
we will be able to file the INDs, or foreign equivalent, in the timeframe which we currently
expect, or at all.
Because clinical trials for our product candidates will be expensive and protracted and their
outcome is uncertain, we must invest substantial amounts of time and money that may not yield
viable products.
Conducting clinical trials is a lengthy, time-consuming and expensive process. We must demonstrate
through laboratory, animal and human studies that our product candidates are both effective and
safe for use in humans. The results of preliminary studies do not predict clinical success. A
number of potential drugs have shown promising results in early testing but subsequently failed to
obtain necessary regulatory approvals. Data obtained from tests are susceptible to varying
interpretations, which may delay, limit or prevent regulatory approval. Regulatory authorities may
refuse or delay approval as a result of many other factors, including changes in regulatory policy
during the period of product development.
Completion of clinical trials may take many years. The length of time required varies substantially
according to the type, complexity, novelty and intended use of the product candidate. The FDA
monitors the progress of each phase of testing, and may require the modification, suspension, or
termination of a trial if it is determined to present excessive risks to patients. The clinical
trial process may also be accompanied by substantial delay and expense and there can be no
assurance that the data generated in these studies will ultimately be sufficient for marketing
approval by the FDA. Our rate of commencement and completion of clinical trials may be delayed by
many factors, including:
Ø
our inability to manufacture sufficient quantities of materials for use in
clinical trials;
Ø
variability in the number and types of patients available for each study;
Ø
difficulty in maintaining contact with patients after treatment, resulting in
incomplete data;
Ø
unforeseen safety issues or side effects;
Ø
poor or unanticipated effectiveness of products during the clinical trials; or
Ø
government or regulatory delays.
We will incur substantial additional expense for and devote a significant amount of time to these
studies. The results of these studies must be submitted to the FDA as part of an NDA, and must be
approved by the FDA before the
product may be marketed. We estimate that it will cost at least $50 million in direct development
costs over 36-42 months to file an NDA and thus bring to market each of our defensin mimetic i.v.
antibiotic product candidate and our heptagonist product candidate (at least $100 million for both
product candidates).
Notwithstanding the submission of any requested additional information, the FDA ultimately may
decide that the application does not satisfy the regulatory criteria for approval and refuse to
approve the application by issuing a “not approvable” letter. Furthermore, the FDA may prevent us
from marketing a product candidate under a label for its desired indications or place other
conditions, including restrictive labeling, on distribution as a condition of any approvals, which
may impair commercialization of the product.
If competitors develop and market products that are more effective, have fewer side effects, are
less expensive than our product candidates or offer other advantages as compared to our product
candidates, our commercial opportunities will be limited.
Other companies have product candidates in development to treat the conditions we are seeking to
ultimately treat. If these competitors are able to develop products that are more effective, have
fewer side effects, are less expensive or offer other advantages as compared to our product
candidates, our commercial opportunities will be limited. Furthermore, if our competitors
commercialize competing products before we do, then our ability to penetrate the market and sell
our products may be impaired.
Our competitors include fully integrated pharmaceutical companies and biotechnology companies,
universities and public and private research institutions. Many of the organizations competing with
us have substantially greater capital resources, larger research and development staffs and
facilities, greater experience in drug development and in obtaining regulatory approvals, and
greater manufacturing and marketing capabilities than we do. These organizations also compete with
us to:
Ø
attract parties for acquisitions, joint ventures or other collaborations;
Ø
license proprietary technology that is competitive with the technology we are
practicing;
Ø
attract funding; and
Ø
attract and hire scientific talent.
In the antibiotic market, many major pharmaceutical companies, such as GlaxoSmithKline, Pfizer,
Bayer, Merck and Sanofi Aventis have already established significant positions. Additionally, many
smaller companies, such as Cubist Pharmaceuticals, Oscient Therapeutics, NovaBay Pharmaceuticals,
Inc., Ceragenix and Inhibitex either have marketed, or are attempting to enter this market by
developing, novel and more potent antibiotics that are intended to be effective against
drug-resistant bacterial strains. In the UFH antagonist market, protamine is the only available
antidote for and antagonist to UFH and, as such, protamine currently dominates this market. Because
of protamine’s virtual monopoly of the UFH antidote/antagonist market, we believe that it may be
difficult for our future UFH antidote/antagonist products to penetrate this market. There may be
additional competitive products about which we are not aware.
Healthcare reform measures could adversely affect our business.
The business and financial condition of pharmaceutical companies is affected by the efforts of
governmental and third party payors to contain or reduce the costs of healthcare. In the U.S. and
in foreign jurisdictions there have been, and we expect that there will continue to be, a number of
legislative and regulatory proposals aimed at changing the healthcare system. For example, in some
countries other than the U.S., pricing of prescription drugs is subject to government control, and
we expect proposals to implement similar controls in the U.S. to continue. The implementation of
such additional controls could have the effect of reducing the prices that we are able to charge
for any products we develop and sell through these plans. Prescription drug legislation and related
amendments or regulations could also cause third-party payors other than the federal government,
including the states under the Medicaid program, to discontinue coverage for any products we
develop or to lower reimbursement amounts that they pay.
Further federal, state and foreign healthcare proposals and reforms are likely. While we cannot
predict the legislative
or regulatory proposals that will be adopted or what effect those proposals may have on our
business, including the future reimbursement status of any of our product candidates, the pendency
or approval of such proposals could result in a decrease in our stock price or limit our ability to
raise capital or to obtain strategic partnerships or licenses.
Because our activities may involve the use of hazardous materials, we may be subject to claims
relating to improper handling, storage or disposal of these materials that could be time consuming
and costly.
If we use biological and hazardous materials in a manner that causes injury, we may be liable for
damages. Our research and development activities may involve the controlled use of potentially
harmful biological materials as well as hazardous materials, chemicals and various radioactive
compounds. We cannot completely eliminate the risk of accidental contamination or injury from the
use, storage, handling or disposal of these materials. In the event of contamination or injury, we
could be held liable for damages that result, and any liability could exceed our resources. We are
subject to federal, state and local laws and regulations governing the use, storage, handling and
disposal of these materials and specified waste products. The cost of compliance with these laws
and regulations could be significant.
Risks Related to our Common Stock
A decline in the price of our common stock could affect our ability to raise further working
capital and adversely impact our ability to continue operations.
A prolonged decline in the price of our common stock could result in a reduction in the liquidity
of our common stock and a reduction in our ability to raise capital. Because a significant portion
of our operations has been and may continue to be financed through the sale of equity securities, a
decline in the price of our common stock could be especially detrimental to our liquidity and our
operations. Such reductions may force us to reallocate funds from other planned uses and may have a
significant negative effect on our business plans and operations, including our ability to develop
our product candidates and continue our current operations. If our stock price declines, we can
offer no assurance that we will be able to raise additional capital or generate funds from
operations sufficient to meet our obligations. If we are unable to raise sufficient capital in the
future, we may not be able to have the resources to continue our normal operations.
The market price for our common stock may also be affected by our ability to meet or exceed
expectations of analysts or investors. Any failure to meet these expectations, even if minor, may
have a material adverse effect on the market price of our common stock.
If we issue additional shares in the future, it will result in the dilution of our existing
stockholders.
Our certificate of incorporation authorizes the issuance of up to 90,000,000 shares of common stock
with a $0.001 par value and 10,000,000 preferred shares with a par value of $0.001, of which
32,039,000 common shares were issued and outstanding as of December 31, 2007. Our board of
directors may fix and determine the designations, rights, preferences or other variations of each
class or series within each class of preferred stock and may choose to issue some or all of such
shares to provide additional financing or acquire more businesses in the future.
Moreover, in the past, we issued warrants and options to acquire shares of common stock. To the
extent these warrants and/or options are ultimately exercised, you will sustain future dilution. As
of December 31, 2007, we had warrants and options to purchase 11,418,000 shares of our common stock
outstanding. Warrants to purchase 3,054,000 shares of our common stock have weighted average
anti-dilution protection if we sell certain securities at a price per share less than $1.66 per
share.
The issuance of any shares for acquisition, licensing or financing efforts, upon conversion of any
preferred stock or exercise of warrants and options, pursuant to our equity compensation plans, or
otherwise will result in a reduction of the book value and market price of the outstanding shares
of our common stock. If we issue any such additional shares, such issuance will cause a reduction
in the proportionate ownership and voting power of all current stockholders. Further, such issuance
may result in a change of control of our corporation.
Trading of our stock may be restricted by the Securities Exchange Commission’s penny stock
regulations, which may limit a stockholder’s ability to buy and sell our stock.
The Securities and Exchange Commission has adopted regulations that generally define “penny stock”
to be any equity security that has a market price (as defined) less than $5.00 per share or an
exercise price of less than $5.00 per share, subject to certain exceptions. Our securities are
covered by the penny stock rules, which impose additional sales practice requirements on
broker-dealers who sell to persons other than established customers and “accredited investors”. The
term “accredited investor” refers generally to institutions with assets in excess of $5,000,000 or
individuals with a net worth in excess of $1,000,000 or annual income exceeding $200,000 or
$300,000 jointly with their spouse. The penny stock rules require a broker-dealer, prior to a
transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk
disclosure document in a form prepared by the Securities and Exchange Commission, which provides
information about penny stocks and the nature and level of risks in the penny stock market. The
broker-dealer also must provide the customer with current bid and offer quotations for the penny
stock, the compensation of the broker-dealer and its salesperson in the transaction and monthly
account statements showing the market value of each penny stock held in the customer’s account. The
bid and offer quotations, and the broker-dealer and salesperson compensation information, must be
given to the customer orally or in writing prior to effecting the transaction and must be given to
the customer in writing before or with the customer’s confirmation. In addition, the penny stock
rules require that prior to a transaction in a penny stock not otherwise exempt from these rules,
the broker-dealer must make a special written determination that the penny stock is a suitable
investment for the purchaser and receive the purchaser’s written agreement to the transaction.
These disclosure requirements may have the effect of reducing the level of trading activity in the
secondary market for the stock that is subject to these penny stock rules. Consequently, these
penny stock rules may affect the ability of broker-dealers to trade our securities. We believe that
the penny stock rules discourage investor interest in and limit the marketability of our common
stock.
Financial Industry Regulatory Authority (FINRA) sales practice requirements may also limit a
stockholder’s ability to buy and sell our stock.
In addition to the “penny stock” rules described above, FINRA has adopted rules that require that
in recommending an investment to a customer, a broker-dealer must have reasonable grounds for
believing that the investment is suitable for that customer. Prior to recommending speculative low
priced securities to their non-institutional customers, broker-dealers must make reasonable efforts
to obtain information about the customer’s financial status, tax status, investment objectives and
other information. Under interpretations of these rules, FINRA believes that there is a high
probability that speculative low priced securities will not be suitable for at least some
customers. FINRA requirements make it more difficult for broker-dealers to recommend that their
customers buy our common stock, which may limit your ability to buy and sell our stock and have an
adverse effect on the market for our shares.
Our common stock is illiquid and the price of our common stock may be negatively impacted by
factors that are unrelated to our operations.
Our common stock is currently quoted on the OTC Bulletin Board. Trading of our stock through the
OTC Bulletin Board is frequently thin and highly volatile. There is no assurance that a sufficient
market will develop in the stock, in which case it could be difficult for stockholders to sell
their stock. The market price of our common stock could fluctuate substantially due to a variety of
factors, including market perception of our ability to achieve our planned growth, quarterly
operating results of our competitors, trading volume in our common stock, changes in general
conditions in the economy and the financial markets or other developments affecting our competitors
or us. In addition, the stock market is subject to extreme price and volume fluctuations. This
volatility has had a significant effect on the market price of securities issued by many companies
for reasons unrelated to their operating performance and could have the same effect on our common
stock.
We have never paid dividends on our common stock and do not anticipate paying any in the
foreseeable future.
We have never declared or paid a cash dividend on our common stock and we do not expect to have any
extra cash with which to pay cash dividends in the foreseeable future. If we do have available
cash, we intend to use it to grow our business.
Sales of a substantial number of shares of our common stock into the public market may result in
significant downward pressure on the price of our common stock and could affect your ability to
realize the current trading price of our common stock.
Sales of a substantial number of shares of our common stock in the public market, including by
persons or entities holding a large number of shares of our common stock, could cause a reduction
in the market price of our common stock. To the extent stockholders sell shares of common stock,
the price of our common stock may decrease due to the additional shares of common stock in the
market.
Any significant downward pressure on the price of our common stock as stockholders sell their
shares could encourage short sales by the selling stockholders or others. Any such short sales
could place further downward pressure on the price of our common stock.
Delaware law and our amended and restated certificate of incorporation and amended and restated
bylaws contain provisions that could delay and discourage takeover attempts that stockholders may
consider favorable.
Certain provisions of our amended and restated certificate of incorporation, or certificate of
incorporation, and amended and restated bylaws, or bylaws, and applicable provisions of Delaware
corporate law may make it more difficult for or prevent a third party from acquiring control of us
or changing our board of directors and management. These provisions include:
Ø
the ability of our board of directors to issue preferred stock with voting or
other rights or preferences;
Ø
limitations on the ability of stockholders to amend our charter documents,
including stockholder supermajority voting requirements;
Ø
requirements that special meetings of our stockholders may only be called by the
chairman of our board of directors, our president, or upon a resolution adopted by, or an
affirmative vote of, a majority of our board of directors; and
Ø
advance notice procedures our stockholders must comply with in order to nominate
candidates for election to our board of directors or to place stockholders’ proposals on
the agenda for consideration at meetings of stockholders.
We will also be afforded the protections of Section 203 of the Delaware General Corporation Law,
which will prevent us from engaging in a business combination with a person who acquires at least
15% of our common stock for a period of three years from the date such person acquired such common
stock, unless board or stockholder approval were obtained.
Any delay or prevention of a change of control transaction or changes in our board of directors or
management could deter potential acquirors or prevent the completion of a transaction in which our
stockholders could receive a substantial premium over the then current market price for their
shares.
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
We currently lease 24,223 square feet of office and laboratory facilities at 170 N. Radnor-Chester
Road; Suite 300 in Radnor, Pennsylvania, pursuant to a twelve-year lease. All of our tangible
personal property, consisting mainly of computers, office furniture and lab equipment, is located
at our leased office and laboratory facilities and is in good operating condition and repair
(subject to normal wear and tear).
Item 3. Legal Proceedings.
To our knowledge, we are not a party to any pending or threatened legal proceedings. To our
knowledge, no governmental authority is contemplating commencing a legal proceeding in which we
would be named as a party.
Item 4. Submission of Matters to a Vote of Security Holders.
Item 5. Market for Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market Information
Since August 18, 2006, our common stock has been traded on the OTC Bulletin Board under the symbol
“PYMX”. The market for our common stock is limited and volatile. The following table sets forth the
range of high and low sales prices for our common stock for each of the periods indicated as
reported by the OTC Bulletin Board. The prices quoted on the OTC Bulletin Board reflect
inter-dealer prices, without retail mark-up, markdown or commissions. The OTC Bulletin Board prices
listed below may not represent actual transaction prices.
Pursuant to a Registration Rights Substitution Agreement, as amended, the holders of outstanding
warrants to purchase 3,054,000 shares of common stock have rights, subject to certain conditions,
to require us to include the shares of common stock issuable upon exercise of these warrants in a
separate registration statement.
Holders of Record
As of December 31, 2007, there were approximately 700 holders of record of shares of Common Stock.
Dividends
Since our reincorporation in Delaware in March 24, 2005, we have not paid or declared any cash
dividends on our common stock. We currently intend to retain any earnings for future growth and,
therefore, do not expect to pay cash dividends on our common stock in the foreseeable future.
The following graph compares the cumulative total return on our common stock relative to the
cumulative total returns of the NASDAQ Composite index and the NASDAQ Biotechnology index for the
period from August 16, 2006, the day we commenced trading. An investment of $100 (with reinvestment
of all dividends) is assumed to have been made in our common stock and in each of the indexes on
August 16, 2006 and its relative performance is tracked through December 31, 2007.
COMPARISON OF CUMULATIVE TOTAL RETURAN*
AMONG POLYMEDIX, INC.,
THE NASDAQ COMPOSITE INDEX
ANDTHE NASDAQ BIOTECHNOLOGY INDEX
* $100
invested on August 16, 2006 in stock or index-including reinvestment of dividends.
The following table provides information about the sales of unregistered securities for the
past three years.
Total Offering
Exemption from
Date of Sale
Title of Security
Amount
Price
Purchasers
Registration Claimed
Oct. 2007
Common Stock
12,500 shares
—(1
)
Accredited
Section 4(2) of the
investors (7)
Securities Act
of 1933 and Rule 506
promulgated
thereunder
Dec. 2006
Series 1 Preferred
462,294 shares
(2
)
Accredited
Section 4(2) of the
Convertible Stock
investors (7)
Securities Act
of 1933 and Rule 506
promulgated
thereunder
Nov.
2005 — Feb. 2006
Series 1 Preferred
7,055,000 shares
$
21,165,000
Accredited
Section 4(2) of the
Convertible Stock
investors (7)
Securities Act
of 1933 and Rule 506
promulgated
thereunder
Nov. 2005
— Dec 2007
Warrant to Purchase
3,054,000 shares
—(3
)
Accredited
Section 4(2) of the
Common Stock
investor (7)
Securities Act
of 1933 and Rule 506
promulgated
thereunder
Aug. 2005
— Dec. 2006
Common Stock and
4,305,667
—(4
)
Directors,
Rule 701
Options to Purchase
officers,
promulgated
Common Stock
employees and
under the
consultants
Securities Act of
1933
Feb. 2004
— Feb. 2005
Common Stock
618,000 shares
—(5
)
Directors,
Rule 701 promulgated
officers,
under the
employees and
Securities Act of
consultants
1933
Jan. 2005
— Dec. 2006
Common Stock
596,000 shares
—(6
)
Directors,
Section 4(2) of the
officers,
Securities Act
employees and
of 1933 and Rule 506
consultants
promulgated
thereunder
(1)
Issued to the University of Massachusetts in exchange for the exclusive right and license to
use, develop, manufacture, market and exploit certain intellectual property owned by the
University of Massachusetts.
(2)
Represents unregistered securities issued as dividends on Series 1 Preferred Stock.
(3)
Issued to Fordham Financial Management, Inc., as partial consideration for placement agent
services rendered in connection with our private placement of Series 1 Preferred Stock,
warrants to purchase 3,054,000 shares of common stock at an exercise price of $1.66 per share,
as adjusted during the fourth quarter of 2007 for weighted average anti-dilution protection.
These warrants expire on November 8, 2010.
(4)
Issued pursuant to the PolyMedix, Inc. 2002 Equity Compensation Plan and the PolyMedix, Inc.
2005 Omnibus Equity Compensation Plan as an incentive to our directors, officers, employees
and consultants. We received no cash consideration for the incentive grants. Options issued
have exercise prices of between $1.50 and $4.10 per share and expire ten years from their
respective grant date.
(5)
Represents common and restricted common stock incentive grants to directors, officers,
employees and consultants made pursuant to the PolyMedix Pharmaceuticals, Inc. 2002 Equity
Compensation Plan. We received no cash consideration for the incentive grants.
(6)
Represents common and restricted common stock incentive grants to our directors, officers,
employees and consultants. We received no cash consideration for the incentive grants.
(7)
As defined in Rule 501 of Regulation D promulgated under the Securities Act of 1933.
Equity compensation plans
approved by security holders
(1)
5,421,000
$
1.75
112,223
Equity compensation plans not
approved by security holders
—
—
—
Total:
5,421,000
$
1.75
112,223
(1)
Represents 1,422,000 and 3,999,000 shares of our common stock issuable under our 2002 Equity
Compensation Plan and our 2005 Omnibus Equity Compensation Plan, respectively.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis should be read in conjunction with the consolidated financial
statements including the notes thereto. This discussion and analysis may contain forward-looking
statements based upon current expectations that involve risks and uncertainties. Our actual results
may differ materially as a result of various factors, including those set forth under “Risk
Factors” or elsewhere in this Form 10-K.
Overview
We are a development stage biotechnology company focused on treating life threatening, serious
infectious diseases and acute cardiovascular disorders with synthetic small molecule compounds that
mimic the activity of large natural protein molecules, compounds referred to as biomimetics. Using
our proprietary computational drug design technology, we have created novel defensin mimetic
antibiotic compounds, heparin antagonist compounds (or “heptagonist”) and other drug compounds
intended for human therapeutic use. Since 2002, we have been a development stage enterprise, and
accordingly, our operations have been directed primarily toward developing business strategies,
raising capital, research and development activities, conducting pre-clinical testing of our
product candidates, exploring marketing channels and recruiting personnel.
We have incurred operating losses since inception, have not generated any product sales revenues
and have not achieved profitable operations. Our deficit accumulated during the development stage
through December 31, 2007 aggregated $25,873,000, and we expect to continue to incur substantial
losses in future periods.
We are highly dependent on the success of our research, development and licensing efforts and,
ultimately, upon regulatory approval and market acceptance of our products under development. Our
short and long-term capital requirements depend upon a variety of factors, including market
acceptance for our technologies and product candidates and various other factors. We did not raise
as much additional funding in 2007 as we had planned, and, as a result, we scaled back our
pre-clinical research efforts. We anticipate that in order to achieve our operational objectives,
our expenses and cash requirements will increase from historical levels and we anticipate the need
to raise additional capital during 2008 in order to fully fund the research and development of our
product candidates. These factors have raised substantial doubt about our ability to continue as a
going concern for the foreseeable future. If additional capital resources are not obtained during
2008, we will scale-back, postpone or eliminate certain development programs until such additional
capital resources have been obtained. Our consolidated financial statements have been prepared on
the basis of PolyMedix Inc. continuing as a going concern and do not include any adjustments to
reflect the possible future effects on the recoverability and classification of assets or the
amounts and classification of liabilities that may result from the outcome of our ability to
continue as a going concern.
The following discussion and analysis provides information that we believe is relevant to an
assessment and understanding of our results of operations for the years ended December 31, 2007,
2006 and 2005, and financial condition for the years ended December 31, 2007 and 2006.
Critical Accounting Policies and Practices
The preparation of our Consolidated Financial Statements in conformity with U. S. generally
accepted accounting principles requires management to adopt critical accounting policies and to
make estimates and assumptions that affect the amounts reported in our Consolidated Financial
Statements and accompanying notes. These critical accounting policies and estimates have been
reviewed by our Audit Committee. The principal items in our Consolidated Financial Statements
reflecting critical accounting policies or requiring significant estimates and judgments are as
follows:
Stock-based compensation
From our inception, August 8, 2002, we applied the fair value recognition provisions of Statement
of Financial Accounting Standards (“SFAS”) No. 123, Accounting for Stock-Based Compensation and
have, since inception, recognized equity compensation expense over the requisite service period.
Beginning January 1, 2006, we adopted SFAS No. 123(R), Share Based Payment using the
modified-prospective method. There was no significant impact from switching from SFAS No. 123 to
SFAS No. 123(R). Since inception, we have used the Black-Scholes formula to estimate the fair value
of stock options and have elected to continue to estimate the fair value of stock options using the
Black-Scholes formula. The volatility and expected term assumptions have the most significant
effect on the results obtained from the Black-Scholes option-pricing model. We have to date assumed
that stock options have an expected life of five years, representing about half of their
contractual life, and assumed common stock volatility of between 41% and 74%. Higher estimates of
volatility and expected life of the option increase the value of an option and the resulting
expense. Given the absence of an active market for our common stock, the fair value of our common
stock has periodically been estimated using several criteria, including the trading of our common
stock on the OTC Bulletin Board (when trading), progress and milestones achieved in our research
activities along with the price per share of our preferred and common stock offerings.
Since inception, our only revenues have been from grants and other research arrangements. Grant and
research revenues were $1,126,000 and $821,000 for the years ended December 31, 2007 and 2006,
respectively. The increase in grant and research revenue was attributable to funds received in
connection with our advanced
technology grant from the National Institute of Health, or NIH, in support of our development of
our i.v. antibiotic product candidate, which commenced in April 2006.
We incurred research and development expenses of $9,328,000 and $3,306,000 for the years ended
December 31, 2007 and 2006, respectively. The increase was the result of increased headcount and
outside laboratory research costs associated with our preclinical development, GMP compliant
manufacturing and GLP compliant toxicology, safety pharmacology and genotoxicity studies for
PMX-60056 and PMX-30063 planned for 2008. Research and development costs include $311,000 and
$205,000 related to stock-based compensation expense for the years ended December 31, 2007 and
2006, respectively.
General and administrative expenses were $4,473,000 and $4,174,000 for the years ended December 31,2007 and 2006, respectively. The increase was the result of facility, investor relations and legal
costs. General and administrative costs include $936,000 and $934,000 related stock-based
compensation expense for the years ended December 31, 2007 and 2006, respectively.
Interest income and other expenses were $511,000 and $693,000 for the years ended December 31, 2007
and 2006, respectively. The decrease was a result of our decreased average cash and investment
balances along with declining interest rates.
Historical Cash Flows
Operating Activities. Cash used in operating activities during the year ended December 31, 2007
increased to $8,266,000 as compared to $4,319,000 used for the year ended December 31, 2006. The
increase is attributed primarily to increased research and development spending and increased
general and administrative expenses.
Investing Activities. Cash used for investing activities represents cash paid for purchases of
investments and property and equipment, net of maturities of investments. During the year ended
December 31, 2007 and 2006, we purchased $9,880,000 and $10,810,000 of investments, respectively.
During the year ended December 31, 2007 and 2006, maturities of our investments were $12,098,000
and $5,000,000, respectively. During the years ended December 31, 2007 and 2006, property and
equipment purchases were $266,000 and $274,000, respectively.
Financing Activities. We have financed our operating and investing activities primarily from the
proceeds from the sale of equity securities. During the years ended December 31, 2007 and 2006, we
received $2,558,000 and $3,720,000, respectively, in net proceeds of such issuances of equity
securities. Additionally, during 2007 we received $184,000 from the exercise of stock options.
Grant and research revenues were $821,000 and $142,000 for the years ended December 31, 2006 and
2005, respectively. The increase in grant and research revenue was attributable to funds received
in connection with our advanced technology grant from the NIH in support of our development of our
i.v. antibiotic product candidate, which commenced in April 2006.
We incurred research and development expenses of $3,306,000 and $2,526,000 for the years ended
December 31, 2006 and 2005, respectively. The increase was the result of increased headcount and
outside laboratory research costs associated with our preclinical development and lead optimization
of our antimicrobial program. Research and development costs include $205,000 and $491,000 related
to stock-based compensation expense for the years ended December 31, 2006 and 2005, respectively.
General and administrative expenses were $4,174,000 and $2,434,000 for the years ended December 31,2006 and 2005, respectively. The increase was the result of facility, investor relations and legal
costs. General and administrative costs include $934,000 and $1,196,000 related stock-based
compensation expense for the years ended December 31, 2006 and 2005, respectively. Of the increase,
facility, investor relations and legal costs increased by approximately $466,000, $135,000 and
$329,000 respectively.
Interest income was $693,000 and $54,000 for the years ended December 31, 2006 and 2005,
respectively. The increase was a result of our increased average cash and investment balances along
with increased interest rates.
Operating Activities. Cash used in operating activities during the year ended December 31, 2006
increased to $4,319,000 as compared to $2,528,000 used for the year ended December 31, 2005. The
increase is attributed primarily to increased research and development spending and increased
general and administrative expenses.
Investing Activities. Cash used for investing activities represents cash paid for purchases of
investments and property and equipment, net of maturities of investments. During the year ended
December 31, 2006, we purchased $10,810,000 of investments, of which $5,000,000 matured during
2006. We had no investment activity during 2005. During the years ended December 31, 2006 and
2005, property and equipment purchases were $274,000 and $76,000, respectively.
Financing Activities. We have financed our operating and investing activities primarily from the
proceeds of private placements of common and preferred stock. During the years ended December 31,2006 and 2005, we received $3,720,000 and $14,186,000, respectively, in net proceeds of issuances
of preferred stock.
Liquidity and Capital Resources
As of December 31, 2007 and December 31, 2006, we had cash and investment balances of approximately
$8,903,000 and $14,529,000, respectively, and total liabilities of approximately $4,588,000 and
$1,396,000, respectively. The decrease in our cash balance was attributable to cash used to fund
ongoing operations, partially offset by proceeds realized from the sale of our common stock units
during the last quarter of 2007. During the fourth quarter of 2007, we received proceeds, net of
fees and expenses, of $2,106,000 from the sale of our common stock units.
We are a development stage company and have not experienced significant revenue generating
activities since our formation. We reached a positive working capital position for the first time
in the fourth quarter of 2005 as a result of our financing activities. We have incurred operating
losses for each year since our inception in 2002. To achieve operating profits, we, alone or with
others, must successfully identify, develop and market product candidates. Our principal
activities, from the beginning of our development stage, have been organizational matters, issuance
of stock, product research and development, fund raising and market research.
In the near-term, we expect to continue to incur significant and increasing operating losses as a
result of the research and development expenses we expect to incur in developing our product
candidates and the general and administrative expenses we expect to incur as a reporting company
under the Securities Exchange Act of 1934, as amended. Additionally, we do not expect to generate
any revenues from sources other than research grants for the foreseeable future.
During 2008, we plan to scale our operations such that our current cash and investment balances
will fund operations at least for the next twelve months. If we are unable to secure adequate
additional funding during the first half of 2008, we will delay, scale-back or eliminate certain of
our research, drug discovery or development activities or certain other aspects of our operations
and our business until such time as we are successful in securing adequate additional funding. We
did not raise as much additional funding in 2007 as we had planned, and as a result, we scaled-back
our pre-clinical research efforts. Our short and long-term capital requirements depend upon a
variety of factors, including market acceptance for our technologies and product candidates and
various other factors, many of which we cannot control, including:
Ø
continued progress of and increased spending related to our research and development
activities, including our plan to hire additional research and development employees;
Ø
progress with preclinical experiments and clinical trials;
Ø
increased general and administrative expenses related to our being a reporting company;
prosecuting and enforcing patent claims;
Ø
technological and market developments;
Ø
the ability to establish product development arrangements;
Ø
the cost of manufacturing development;
Ø
effective marketing activities and arrangements; and
We expect to seek additional funds through equity or debt financing, collaborative or other
arrangements with corporate partners, and from other sources. We may not be able to obtain any
additional financing on terms acceptable to us, if at all, or we may not raise as much as we
expect. If adequate additional funds are not available when required, we will have to delay,
scale-back or eliminate certain of our research, drug discovery or development activities or
certain other aspects of our operations and our business will be materially and adversely affected.
Our consolidated financial statements have been prepared on the basis of PolyMedix Inc. continuing
as a going concern and do not include any adjustments to reflect the possible future effects on the
recoverability and classification of assets or the amounts and classification of liabilities that
may result from the outcome of our ability to continue as a going concern.
We are subject to many risks associated with early-stage businesses, including the above-discussed
risks associated with the ability to raise capital. Please see the section entitled “Risk Factors”
for more information regarding risks associated with our business.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as defined in Item 303(c)(2) of Regulation S-B.
Commitments and Contingencies
As described above, we believe we can scale our operations such that current cash and investment
balances are adequate to fund operations, including the following commitments and contingencies, at
least for the next twelve months if other factors do not negatively impact our cash and investment
balances. If we are unable to secure adequate additional funding during the first half of 2008, we
will delay, scale-back or eliminate certain of our research, drug discovery or development
activities or certain other aspects of our operations and our business until such time as we are
successful in securing adequate additional funding.
Capital Lease
We have entered into lease agreements for laboratory equipment. The initial obligation under these
capital leases was $331,000. The value of the laboratory equipment acquired in connection with
these leases was $398,000 and the depreciation associated with these assets is included along with
that of other owned property and equipment. These equipment leases have terms of up to three years,
at interest rates ranging from 9.5% to 11.5% and contain bargain purchase options. In connection
with these capital leases, we paid the following (in thousands):
In June 2006, we entered into an operating lease agreement for 24,223 square feet of combined
office and laboratory space located in Radnor, Pennsylvania. The initial term of the lease is 12
years. Payments under the lease commenced on December 1, 2006. Our annual future minimum lease
payments under this non-cancelable operating lease are as follows (in thousands):
Operating Leases
2008
$
398
2009
497
2010
589
2011
667
2012
686
Thereafter
4,315
Total minimum lease payments
$
7,152
Prior to the commencement of our current operating lease for our Radnor Facility, we leased
approximately 3,500 square feet of combined office and laboratory space on a month-to-month basis
in Philadelphia, Pennsylvania. Rent expense was $598,000, $559,000 and $109,000 and $1,279,000 for
the years ended December 31, 2007, 2006, and 2005, and for the period from August 8, 2002
(Inception) to December 31, 2007, respectively.
Patent License Agreements
University of Pennsylvania. In January 2003, we entered into a Patent License Agreement with the
University of Pennsylvania, or Penn. Under the terms of the agreement, we were granted an
exclusive, worldwide royalty-bearing license to make and sell products utilizing seven of Penn’s
issued or pending patents for the life of such patents. One issued patent and five patent
applications cover the composition of matter on antimicrobial compounds, including small molecules,
oligomers and polymers. One patent application covers the composition and use of polycatonic
compounds for treating cancer. If a change-of-control event occurs, in which we transfer the
license to these patents to a third party, we are acquired by another company, or we conduct an
initial public offering of our securities, we are required to pay a 3% royalty on the gross sales
for licensed products that are sold as pharmaceuticals and a 1.5% royalty on products sold as
coatings for use in medical devices. We are permitted to sublicense the patents provided that (a)
the sublicensee is prohibited from further licensing of the patents and (b) the sublicensee is
subject to all of the terms of the original license granted to us. In addition, we are required to
share with Penn any consideration we receive from sublicensing our patents to a third party.
University of Massachusetts. We have entered a five-year sponsored research agreement with the
University of Massachusetts, or UMass. Under the terms of this agreement, we have the exclusive
option to license any intellectual property that may be generated by Dr. Gregory Tew pursuant to
research sponsored under the agreement. We may exercise this option by issuing 7,500 shares of our
common stock to UMass for each $100,000 of research conducted by Dr. Tew. If we exercise this
option, we are also required to reimburse UMass for direct patent costs incurred by it for the
patents licensed by us. During 2007, we issued 12,500 shares to UMass in connection with this
agreement. We sponsored $107,000 and $118,000 of Dr. Tew’s research for 2007 and 2006,
respectively.
Other
Agreements with Employees. We have entered into employment agreements with various executives.
These agreements provide for severance arrangements and accelerated vesting of equity compensation
awards in the event that the executive is terminated by us other than for cause or disability or if
the executive resigns or good reason.
Credit Line. In April 2006, we entered into a line of credit agreement with a financial
institution. This line of credit provides for monthly interest-only payments at a variable per
annum rate of 3% plus the 30-day LIBOR rate. The amount available under this line of credit ranges
from 85% to 92% of cash and investments pledged as collateral, based upon the amount and security
type. There is currently no outstanding balance on this line of credit. In June 2006, we entered
into a letter of credit agreement with the same financial institution to secure our payment
obligations under our facility operating lease. This letter of credit is for $1,400,000, expires
on December 1, 2008 and is secured by our credit line.
Termination Benefits. During 2007, in connection with agreements with certain terminated employees,
we agreed to grant 50,000 shares of common stock as a one-time termination benefit to certain
employees. These shares will be issued ratably over the first five-months of 2008. We recognized
$58,000 in equity based compensation costs associated with these shares which is included in
research and development costs on our Consolidated Statements of Operations.
In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements” (“SFAS 157”). SFAS 157
defines fair value, establishes a framework for measuring fair value and expands disclosure about
fair value measurements. SFAS 157 is effective for financial assets and liabilities in fiscal years
beginning after November 15, 2007 and for non-financial assets and liabilities in fiscal years
beginning after March 15, 2008. We do not expect the adoption of SFAS 157 to have a material impact
on our consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159 “The Fair Value Option for Financial Assets and
Financial Liabilities (SFAS 159). SFAS 159 permits entities to choose to measure many financial
assets and financial liabilities at fair value. Unrealized gains and losses on items for which the
fair value option has been elected are reported in earnings. SFAS 159 is effective for fiscal years
beginning after November 15, 2007. We do not expect that the adoption of SFAS 159 will have a
material impact on our consolidated financial statements.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk
Our investment assets consist of U.S. Treasury obligations. The market value of such investments
fluctuates with current market interest rates. In general, as rates increase, the market value of a
debt instrument would be expected to decrease. The opposite is also true. To minimize such market
risk, we have in the past and, to the extent possible, will continue in the future, to hold such
debt instruments to maturity at which time the debt instrument will be redeemed at its stated or
face value. Due to the short duration and nature of these instruments, we do not believe that we
have a material exposure to interest rate risk related to our investment portfolio. The investment
portfolio at December 31, 2007 totaled $3,967,000, and the weighted-average interest rate was
approximately 4.69% with maturities of investments ranging up to 6 months.
Foreign Exchange Risk
We have entered into some agreements denominated, wholly or partly, in Canadian Dollars, Euros or
other foreign currencies, and, in the future, we may enter into additional, significant agreements
denominated in foreign currencies. If the values of these currencies increase against the dollar,
our costs would increase. To date, we have not entered into any contracts to reduce the risk of
fluctuations in currency exchange rates. In the future, depending upon the amounts payable under
any such agreements, we may enter into forward foreign exchange contracts to reduce the risk of
unpredictable changes in these costs. However, due to the variability of timing and amount of
payments under any such agreements, foreign exchange contracts may not mitigate the potential
adverse impact on our financial results.
Item 8. Financial Statements and Supplementary Data.
Our consolidated financial statements, accompanying notes and Report of Independent Registered
Public Accounting Firm are attached to this Annual Report on Form 10-K beginning on page F-1.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Item 9A(T). Controls and Procedures.
Conclusions regarding disclosure controls and procedures. An evaluation was performed under the
supervision and with the participation of our management, including our Chief Executive Officer, or
CEO, and Chief Financial Officer, or CFO, of the effectiveness of our disclosure controls and
procedures, as such term is defined under Rule 13a-15(e) or 15d-15(e) promulgated under the
Securities Exchange Act of 1934, as amended (the “Exchange Act”) as of the end of the period
covered by this report. Based on that evaluation, our management, including the CEO and CFO,
concluded that our disclosure controls and procedures are effective to ensure that information
required to be disclosed by us in reports that we file or submit under the Exchange Act, is
recorded, processed, summarized and
reported, and also accumulated and communicated to our management, including the CEO and CFO, to
allow timely decisions regarding required disclosure as specified in Securities and Exchange
Commission rules and forms.
Management’s Report on Financial Statements. Our management is responsible for the preparation,
integrity and fair presentation of information in our consolidated financial statements, including
estimates and judgments. Our consolidated financial statements presented in this report have been
prepared in accordance with accounting principles generally accepted in the United States. Our
management believes the consolidated financial statements and other financial information included
in this report fairly present, in all material respects, our financial condition, results of
operations and cash flows as of and for the periods presented in this report. The consolidated
financial statements have been audited by Deloitte & Touche LLP, an independent registered public
accounting firm, as stated in their report, which is included herein.
Management’s Report on Internal Control Over Financial Reporting. Our management is responsible for
establishing and maintaining an adequate system of internal control over financial reporting. Our
system of internal control over financial reporting is designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with accounting principles generally accepted in the United States.
Our internal control over financial reporting includes those policies and procedures that:
Ø
pertain to the maintenance of records that, in reasonable detail, accurately and fairly
reflect our transactions and dispositions of our assets;
Ø
provide reasonable assurance that our transactions are recorded as necessary to permit
preparation of our financial statements in accordance with accounting principles generally
accepted in the United States, and that our receipts and expenditures are being made only
in accordance with authorizations of our management and our directors.
Ø
Provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use or disposition of our assets that could have a material effect on the
financial statements.
Because of its inherent limitations, a system of internal control over financial reporting can
provide only reasonable assurance and may not prevent or detect misstatements. Further, because of
changes in conditions, effectiveness of internal controls over financial reporting may vary over
time. Our system contains self-monitoring mechanisms, and actions are taken to correct deficiencies
as they are identified.
Our management conducted an evaluation of the effectiveness of the system of internal control over
financial reporting based on the framework in Internal Control — Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, our
management concluded that our system of internal control over financial reporting was effective as
of December 31, 2007. This annual report does not contain an attestation report by Deloitte &
Touche LLP, our independent registered certified public accounting firm, regarding internal control
over financial reporting. Management’s report was not subject to attestation by our independent
registered certified public accounting firm pursuant to the temporary rules of the Securities and
Exchange Commission that permit us to provide only management’s report in this annual report.
Audit Committee Oversight. The Audit Committee of the Board of Directors, which is comprised solely
of independent directors, has oversight responsibility for our financial reporting process and the
audits of our consolidated financial statements and internal control over financial reporting. The
Audit Committee meets regularly with management and independent registered public accounting firm
to review matters related to the quality and integrity of our financial reporting, internal control
over financial reporting (including compliance matters related to our Code of Ethics and Business
Conduct), and the nature, extent, and results of internal and external audits. Our independent
registered public accounting firm has full and free access and report directly to the Audit
Committee. The Audit Committee recommended, and the Board of Directors approved, that the audited
consolidated financial statements be included in this Form 10-K.
Changes in internal control over financial reporting. There were no changes in our internal control
over financial reporting identified in connection with the evaluation required by paragraph (d) of
Exchange Act Rules 13a-15 or
15d-15 that occurred during our last fiscal quarter that have materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
Item 10. Directors and Executive Officers and Corporate Governance.
The information required by this item is incorporated herein by reference to the similarly named
sections in our definitive proxy statement for the 2008 annual meeting of shareholders.
Code of Conduct
We adopted a Code of Business Conduct and Ethics (“Code of Ethics”) applicable to our principal
executive officer and principal financial and accounting officer and any persons performing similar
functions. In addition, the Code of Ethics applies to our employees, officers, directors, agents
and representatives. The Code of Ethics requires, among other things, that our employees avoid
conflicts of interest, comply with all laws and other legal requirements, conduct business in an
honest and ethical manner, and otherwise act with integrity and in our best interest.
The Code of Ethics includes procedures for reporting violations of the Code of Ethics. In addition,
the Sarbanes-Oxley Act of 2002 requires companies to have procedures to receive, retain and treat
complaints received regarding accounting, internal accounting controls or auditing matters and to
allow for the confidential and anonymous submission by employees of concerns regarding questionable
accounting or auditing matters. The Code of Ethics is intended to comply with the rules of the SEC
and includes these required procedures. The Code of Ethics is available on our website at
www.polymedix.com (under “Investors”). We have also filed the Code of Ethics as Exhibit 14 to our
Annual Report on Form 10-KSB for the year ended December 31, 2006.
Item 11. Executive Compensation.
The information required by this item is incorporated herein by reference to the similarly named
sections in our definitive proxy statement for the 2008 annual meeting of shareholders.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters.
The information required by this item is incorporated herein by reference to the similarly named
sections in our definitive proxy statement for the 2008 annual meeting of shareholders.
Item 13. Certain Relationships and Related Transactions and Director Independence.
The information required by this item is incorporated herein by reference to the similarly named
sections in our definitive proxy statement for the 2008 annual meeting of shareholders.
Item 14. Principal Accountants Fees and Services.
The information required by this item is incorporated herein by reference to the similarly named
sections in our definitive proxy statement for the 2008 annual meeting of shareholders.
Agreement and Plan of Merger and Reorganization, dated October 6, 2005, among the Registrant,
PolyMedix Merger Sub, Inc., PolyMedix Pharmaceuticals, Inc. and those stockholders of Registrant
identified on Exhibit A thereto.(1)
Employment Agreement, dated December 5, 2005, between Edward Smith and the
Registrant.(1)
10.7**
Employment Agreement, dated May 21, 2003, between Dawn P. Eringis and the
Registrant.(1)
10.8**
Employment Agreement, dated March 28, 2003, between Richard Scott, Ph.D. and the
Registrant.(1)
10.9
Letter Agreement, dated February 25, 2004, between Dr. William DeGrado and the
Registrant.(1)
10.10
Lab/Office Space License Agreement for 3701 Market Street, dated February 22, 2006, between the
Registrant and the University City Science Center.(1)
10.11
Pennsylvania Full-Service Lease Agreement for 170 N.
Radnor-Chester Road; Suite 300, Radnor, PA19087, dated May 26, 2006, between the Registrant and the Radnor Properties— SDC,
L.P.(7)
10.12
Financial Consulting Agreement, dated November 8, 2005, between the Registrant and Fordham
Financial Management, Inc.(1)
10.13**
2005 Omnibus Equity Compensation Plan of the Registrant.(8)
In accordance with the requirements of the Exchange Act, the registrant caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes
and appoints each of Nicholas Landekic and Edward F. Smith as his attorney-in-fact, with the full
power of substitution, for him or her in any and all capacities, to sign any amendments to this
Report, and to file the same, with exhibits thereto and other documents in connection therewith,
with the Securities and Exchange Commission, hereby ratifying and confirming all that said
attorney-in-fact, or his substitute or substitutes, may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Exchange Act, this report has been signed below by the
following persons on behalf of the registrant and in the capacities and on the dates indicated:
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
PolyMedix, Inc.
Radnor, Pennsylvania
We have audited the accompanying consolidated balance sheets of PolyMedix, Inc. and its
subsidiary (a development stage company) (the “Company”) as of December 31, 2007 and 2006, and the
related consolidated statements of operations, changes in stockholders’ equity, and cash flows for
each of the three years in the period ended December 31, 2007, and for the period from August 8,2002 (Inception) to December 31, 2007. These financial statements are the responsibility of the
Company’s management. Our responsibility is to express an opinion on these financial statements
based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the financial statements are free of material
misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its
internal control over financial reporting. Our audits included consideration of internal control
over financial reporting as a basis for designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion on the effectiveness of the
Company’s internal control over financial reporting. Accordingly, we express no such opinion. An
audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles used and significant estimates made
by management, as well as evaluating the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
In our opinion, such consolidated financial statements present fairly, in all material
respects, the financial position of the Company as of December 31, 2007 and 2006, and the results
of its operations and its cash flows for each of the three years in the period ended December 31,2007, and for the period from August 8, 2002 (Inception) to December 31, 2007, in conformity with
accounting principles generally accepted in the United States of America.
The accompanying financial statements have been prepared assuming that the Company will
continue as a going concern. The Company is a development stage enterprise engaged in the research
and development of pharmaceutical drug compounds intended for human therapeutic use and has
historically funded its operations through equity financing activities. As discussed in Note 1 to
the financial statements, the Company’s operating losses since inception, current available cash
and investment balances and anticipated level of capital requirements necessary to fund its current
operations raise substantial doubt about its ability to continue as a going concern. Management’s
plans concerning these matters are also described in Note 1 to the financial statements. The
financial statements do not include any adjustments that might result from the outcome of these
uncertainties.
POLYMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED BALANCE SHEETS DECEMBER 31, 2007 AND 2006
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
2007
2006
ASSETS
Current Assets:
Cash and cash equivalents
$
4,936
$
8,601
Short-term investments
3,967
5,928
Prepaid expenses and other current assets
42
60
Total current assets
8,945
14,589
Property and Equipment:
Computers
243
189
Office furniture and lab equipment
774
479
Accumulated depreciation
(240
)
(115
)
Total property and equipment
777
553
TOTAL ASSETS
$
9,722
$
15,142
LIABILITIES AND STOCKHOLDERS’EQUITY
Current Liabilities:
Accounts payable
$
2,341
$
498
Accrued expenses
1,372
473
Short-term portion of capital lease obligation
131
31
Total current liabilities
3,844
1,002
Deferred rent and other accrued expenses
640
325
Long-term portion of capital lease obligation
104
69
Total liabilities
4,588
1,396
Commitments and contingencies
—
—
Stockholders’ Equity:
Preferred Stock ($0.001 par value; 10,000 shares
authorized; 0 and 7,483 issued and outstanding
at December 31, 2007 and 2006, respectively)
(Liquidation value $0 and $22,450 at December31, 2007 and 2006, respectively)
—
7
Common Stock ($0.001 par value; 90,000 shares
authorized; 32,039 and 12,480 issued and
outstanding at December 31, 2007 and 2006,
respectively)
32
12
Additional paid-in capital
30,973
27,437
Deficit accumulated during the development stage
(25,873
)
(13,709
)
Unrealized gain(loss) on available for sale securities
2
(1
)
Total stockholders’ equity
5,134
13,746
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
9,722
$
15,142
The accompanying notes are an integral part of these consolidated financial statements.
POLYMEDIX,
INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
FROM AUGUST 8, 2002 (INCEPTION) THROUGH DECEMBER 31, 2007
(IN THOUSANDS)
In these consolidated financial statements, “PolyMedix,”“we,”“us” and “our” refer to PolyMedix,
Inc. and its wholly owned subsidiary PolyMedix Pharmaceuticals, Inc. and “Common Stock” refers to
PolyMedix’s common stock, par value $0.001 per share
NOTE 1 — ORGANIZATION AND BUSINESS ACTIVITIES
We are a development stage biotechnology company focused on treating life threatening, serious
infectious diseases and acute cardiovascular disorders with synthetic small molecule compounds that
mimic the activity of large natural protein molecules, compounds referred to as biomimetics. Using
our proprietary computational drug design technology, we have created novel defensin mimetic
antibiotic compounds, heparin antagonist compounds (or “heptagonist”) and other drug compounds
intended for human therapeutic use. Since 2002, we have been a development stage enterprise, and
accordingly, our operations have been directed primarily toward developing business strategies,
raising capital, research and development activities, conducting pre-clinical testing of our
product candidates, exploring marketing channels and recruiting personnel.
We have incurred operating losses since inception, have not generated any product sales revenues
and have not achieved profitable operations. Our deficit accumulated during the development stage
through December 31, 2007 aggregated $25,873,000, and we expect to continue to incur substantial
losses in future periods.
The accompanying consolidated financial statements have been prepared on the basis of PolyMedix
Inc. continuing as a going concern. We are highly dependent on the success of our research,
development and licensing efforts and, ultimately, upon regulatory approval and market acceptance
of our products under development. Our short and long-term capital requirements depend upon a
variety of factors, including market acceptance for our technologies and product candidates and
various other factors. We did not raise as much additional funding in 2007 as we had planned, and,
as a result, we scaled back our pre-clinical research efforts. We anticipate that in order to
achieve our operational objectives, our expenses and cash requirements will increase from
historical levels and we anticipate the need to raise additional capital during 2008 in order to
fully fund the research and development of our product candidates. These factors have raised
substantial doubt about our ability to continue as a going concern for the foreseeable future. If
additional capital resources are not obtained during 2008, we will scale-back, postpone or
eliminate certain development programs until such additional capital resources have been obtained.
Our consolidated financial statements do not include any adjustments to reflect the possible future
effects on the recoverability and classification of assets or the amounts and classification of
liabilities that may result from the outcome of our ability to continue as a going concern.
NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles of Consolidation
The consolidated financial statements include the accounts of PolyMedix, Inc. and its wholly owned
subsidiary PolyMedix Pharmaceuticals, Inc. All intercompany accounts and transactions have been
eliminated in consolidation.
Development Stage Company
We are considered to be in the development stage as defined in Statements of Financial Accounting
Standards (SFAS) No.7, “Accounting and Reporting by Development Stage Enterprises”. We have devoted
substantially all of our efforts to business planning, research and development, recruiting
management and technical staff, acquiring operating assets and raising capital.
The preparation of financial statements in conformity with accounting principles generally accepted
in the United States of America requires management to make estimates and assumptions that affect
the reported amounts in the financial statements and accompanying notes. Actual results could
differ from those estimates. Significant estimates include the value of our common stock, preferred
stock and stock options.
Cash and Cash Equivalents
We consider all highly liquid investments purchased with a maturity of three months or less at the
time of purchase to be cash equivalents. Cash and cash equivalents consist of cash in banks and
money market funds.
Short-Term Investments
Investments purchased with a maturity of more than three months, and which mature less than twelve
months from the balance sheet date, are classified as short-term investments. We generally hold
investments to maturity, however, since we may, from time to time, sell securities to meet cash
requirements, we classify our investments as available-for-sale as defined by Statement of
Financial Accounting Standards (“SFAS”), No. 115, “Accounting for Certain Investments in Debt and
Equity Securities.” Available-for-sale securities are carried at market value with unrealized
gains and losses reported as a separate component of Stockholders’ Equity.
Property and Equipment
Property and equipment are stated at cost. Depreciation is computed using the straight-line method
over the estimated useful life of the assets; three years for computer equipment and related
software, seven years for office furniture and five years for lab equipment. When property and
equipment are sold or otherwise disposed of, the cost and related accumulated depreciation are
removed from the accounts and the resulting gain or loss is included in operating expenses.
Depreciation expense was $195,000, $64,000, $38,000 and $310,000 for the years ended December 31,2007, 2006 and 2005 and for the period from August 8, 2002 (Inception) to December 31, 2007,
respectively.
Impairment of Long-Lived Assets
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate
that the basis of an asset may not be recoverable. In accordance with SFAS No. 144, Accounting for
the Impairment or Disposal of Long-Lived Assets, impairment is assessed by measuring the carrying
amount of the assets against the estimated undiscounted future cash flows associated with them. If
the expected future cash flows are less than the carrying value, an impairment loss is recognized
for the amount by which the carrying value exceeds the fair value of the assets.
Grant and Research Revenue
Sponsored grant and research revenues are recognized pursuant to the terms of the related
agreements as work is performed.
Research and Development Expense
Research and development costs are expensed as incurred.
Income Taxes
We recognize deferred tax assets and liabilities for temporary differences between the financial
reporting basis and the tax basis of our assets and liabilities and the expected benefits of using
net operating loss carryforwards. The impact of changes in tax rates and laws on deferred taxes, if
any, applied during the years in which temporary differences are expected to be settled, is
reflected in the consolidated financial statements in the period of enactment. The measurement of
deferred tax assets is reduced, if necessary, if, based on weight of the evidence, it is more
likely than not that some, or all, of the deferred tax assets will not be realized. The effect on
deferred tax assets and liabilities of a change in tax rates is recognized in the period that such
tax rate changes are enacted. At December 31, 2007 and 2006, we have concluded that a full
valuation allowance is necessary for deferred tax assets. (See Note 5).
We adopted the provisions of FIN 48, “Accounting for Uncertainty in Income Taxes — an
Interpretation of FASB Statement No. 109” on January 1, 2007. FIN 48 prescribes the recognition
threshold and measurement attribute for the financial statement recognition and measurement of
uncertain tax positions taken or expected to be taken in a tax return. We had no material amounts
recorded for uncertain tax positions, interest or penalties in the accompanying consolidated
financial statements. See Note 5 for the impact of the adoption of FIN 48.
Loss per Share of Common Stock
We calculate our earnings (loss) per share under the provisions of SFAS No. 128, Earnings Per
Share. SFAS No. 128 requires a dual presentation of “basic” and “diluted” earnings (loss) per share
on the face of the income statement. Basic earnings (loss) per share is computed by dividing
earnings (loss) by the weighted average number of shares of common stock outstanding during each
period. Diluted earnings (loss) per share includes the effect, if any, from the potential exercise
or conversion of securities, such as unvested restricted stock, convertible preferred stock, stock
options and warrants, which would result in the issuance of incremental shares of common stock. In
computing the basic and diluted net loss per share allocable to common stockholders the weighted
average number of shares remains the same for both calculations due to the fact that when a net
loss exists, dilutive shares are not included in the calculation. Potentially dilutive securities
include unvested restricted stock, convertible preferred stock, and options and warrants to
purchase our common stock. These potentially dilutive securities are more fully described in Note
6.
Comprehensive Loss
SFAS No. 130, “Reporting Comprehensive Income,” establishes standards for the reporting of
comprehensive income and its components. Comprehensive income consists of reported net income or
loss and other comprehensive income (i.e. other gains and losses affecting stockholders’ equity
that, under generally accepted accounting principles are excluded from net income or loss as
reported on the statement of operations). The comprehensive loss for each of the periods presented
is materially the same as the net loss in the consolidated statement of operations.
Segment Information
We report segment information in accordance with SFAS No. 131, Disclosure About Segments of an
Enterprise and Related Information. We have one reportable segment operating within the United
States.
Fair Value of Financial Instruments and Credit Risk
The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents,
investments, accounts payable and accrued expenses approximate fair value because of the immediate
or short-term maturity of these financial instruments.
We invest our cash in accordance with a policy objective that seeks to ensure both liquidity and
safety of principal. The policy limits investments to instruments issued by the U.S. government and
commercial institutions with strong investment grade credit ratings and places restrictions on
maturity terms and concentrations by type and issuer.
Stock-Based Compensation
We currently sponsor equity compensation plans. Refer to Note 6. From our inception, August 8,2002, we applied the fair value recognition provisions of Statement of Financial Accounting
Standards (“SFAS”) No. 123, Accounting for Stock-Based Compensation. Beginning January 1, 2006, we
adopted SFAS No. 123(R) using the modified-prospective method, and as such, prior periods have not
been restated. Compensation expense is recognized over the requisite service period. The total
stock-based compensation expense was $1,259,000, $1,139,000, $1,687,000, and $4,440,000 for the
years ended December 31, 2007, 2006 and 2005 and for the period from August 8, 2002 (Inception) to
December 31, 2007, respectively.
Recently Issued and Adopted Accounting Standards
In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements” (“SFAS 157”). SFAS 157
defines fair value, establishes a framework for measuring fair value and expands disclosure about
fair value measurements.
SFAS 157 is effective for financial assets and liabilities in fiscal years beginning after November15, 2007 and for non-financial assets and liabilities in fiscal years beginning after March 15,2008. We do not expect the adoption of SFAS 157 to have a material impact on our consolidated
financial statements.
In February 2007, the FASB issued SFAS No. 159 “The Fair Value Option for Financial Assets and
Financial Liabilities (SFAS 159). SFAS 159 permits entities to choose to measure many financial
assets and financial liabilities at fair value. Unrealized gains and losses on items for which the
fair value option has been elected are reported in earnings. SFAS 159 is effective for fiscal years
beginning after November 15, 2007. We do not expect that the adoption of SFAS 159 will have a
material impact on our consolidated financial statements.
NOTE 3 — SHORT-TERM INVESTMENTS
Short-term investments consist of investment grade fixed income securities with original maturities
of greater than three months. All investments are classified as “available for sale”, and are
considered current assets. As of December 31, 2007, all short-term investments had maturities of
less than one-year.
The following summarizes the short-term investments as of December 31, 2007 and December 31, 2006,
which were invested solely in U.S. government obligations (in thousands):
At December 31, 2007 and 2006, accrued expenses consist of the following (in thousands):
2007
2006
Payroll related costs
$
280
$
328
Other costs
1,092
145
Total accrued expenses
$
1,372
$
473
NOTE 5 — PROVISION FOR INCOME TAXES
We account for income taxes using the asset and liability approach as required by FASB No. 109.
Deferred income taxes are provided for the differences between the tax bases of assets or
liabilities and their reported amounts in the financial statements. This method also requires the
recognition of future tax benefits, such as net operating loss carryforwards and research and
development credits, to the extent that realization of such benefits is more likely than not. At
December 31, 2007 and 2006, deferred tax assets consisted of the following (in thousands):
We believe there is not sufficient evidence that future taxable income will be adequate to permit
the realization of the future tax deductions embedded in this asset. As such, in accordance with
SFAS No. 109, “Accounting for Income Taxes”, we have established a valuation allowance to reduce
the deferred tax asset since it is more likely than not that the deferred tax asset will not be
realized.
The difference between the provision for (benefit from) income taxes and the amount computed by
applying the federal statutory income tax rate to income (loss) before provision for (benefit from)
income taxes is explained below (in thousands):
We have available at December 31, 2007, $19,700,000 in unused operating loss carryforwards that
expire between 2022 and 2027. We also have available at December 31, 2007, $998,000 unused federal
research and development credit carryforwards that may provide future tax benefits and expire
between 2024 and 2027.
The Tax Reform Act of 1986 contains provisions that may limit the NOL and research and development
credit carryforwards available to be used in any given year upon the occurrence of certain events,
including significant changes in ownership interest. Generally, a change in ownership of a company
of greater than 50% within a three-year period results in an annual limitation on that company’s
ability to utilize its NOL carryforwards and tax credits from the tax periods prior to the
ownership change. A study needs to be performed to determine if we have undergone a change in
ownership, however, we believe that we have undergone an ownership change and are subject to an
annual limitation on the use of our NOL carryforwards pursuant to these provisions.
In July 2006, the FASB issued FASB Interpretation No. 48, “Accounting for Uncertainty in Income
Taxes,” or FIN 48, which is applicable for fiscal years beginning after December 15, 2006. FIN 48
clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial
statements in accordance with SFAS No. 109, “Accounting for Income Taxes.” FIN 48 prescribes a
recognition threshold and measurement for financial statement recognition and measurement of a tax
position reported or expected to be reported on a tax return. FIN 48 also provides guidance on
derecognition, classification, interest and penalties, accounting in interim periods, disclosure,
and transition. On January 1, 2007, we adopted FIN 48. Prior to the adoption of FIN 48, our policy
was to recognize tax benefits of uncertain tax positions unless it was probable that a position
would not be sustained. FIN 48 requires application of a “more likely than not” threshold to the
recognition and derecogntion of tax positions. As a result of the adoption of FIN 48, no
adjustments were made to retained earnings for unrecognized tax benefits.
We file income tax returns in the U.S. federal jurisdiction and Pennsylvania. Our policy is to
record interest and penalties on uncertain tax positions as income tax expense. The tax years back
to 2002 remain open to examination by the major taxing jurisdictions where we file. Net operating
loss and credit carryforwards from earlier periods also remain open to examination by taxing
authorities, and will for a period post utilization. We do not reasonably estimate that the
unrecognized tax benefit will change significantly within the next twelve months. Any changes in
the future would also have no impact on the effective tax rate due to the existence of a full
valuation allowance. As
of December 31, 2007, we had no material amounts recorded for uncertain tax positions, interest or
penalties in the accompanying consolidated financial statements.
NOTE 6 — STOCKHOLDERS’ EQUITY
Common Stock
We are authorized to issue 90,000,000 shares of common stock, with a par value of $0.001, of which
32,039,000 and 12,480,000 were issued and outstanding at December 31, 2007 and 2006, respectively.
During the fourth quarter of 2007, we completed a registered direct offering of 2,943,000 units,
each unit consisting of one share of our common stock and a warrant to purchase one share of our
common stock. Each unit was priced at a $1.10 per unit and the exercise price of the warrants
issued is also $1.10. We received gross proceeds of $3,238,000 in the registered direct offering
before fees and expenses. In connection with this registered direct offering, we paid commission
fees and expenses of $1,132,000. The fair value of the warrants at the time of issuance was
estimated using the Black-Scholes option-pricing model with the following assumptions: no
dividends; risk-free interest rate of 3.58%; the contractual life of five years and volatility of
73%. The fair value of the warrants issued was estimated to be $2,015,000.
Preferred Stock
We are authorized to issue 10,000,000 shares of preferred stock, with a par value of $0.001, of
which 0 and 7,483,000 were issued and outstanding at December 31, 2007 and 2006, respectively.
During the first quarter of 2006, we completed a private placement of Series 1 preferred stock. We
received gross proceed of $21,165,000 during the fourth quarter of 2005 and the first quarter of
2006 in connection with this private placement of Series 1 preferred stock. We incurred commission
fees, expenses and financial consulting fees of $3,299,000 and issued warrants to purchase
3,054,000 shares of common stock at an exercise price of $1.66 per share, as adjusted for weighted
average anti-dilution protection. The fair value of the warrants at the time of issuance was
estimated using the Black-Scholes option-pricing model with the following assumptions: no
dividends; risk-free interest rate of 4.45%; the contractual life of five years and volatility of
60%. The fair value of the warrants issued was estimated to be $2,149,000. Each share of Series 1
preferred stock was convertible into two shares of common stock at any time at the option of the
holder. Cumulative annual dividends, payable in shares of Series 1 preferred stock or cash at the
option of the Board of Directors, accrued at an annual rate of 6% ($0.18 per share). Cumulative
dividends were paid for dividends accrued through 2006. This dividend was paid in 462,000 shares of
Series 1 preferred stock that was valued at $3,026,000 as of the date of dividend declaration. The
Series 1 preferred stock was convertible into 924,000 shares of common stock, which had a weighted
average fair value of $6.55 on the dividend declaration dates. The value of the beneficial
conversion feature of $1,639,000 was recorded as dividends on the Series 1 preferred stock through
the earliest date that such preferred stock dividends can be converted.
During the second quarter of 2007, our stockholders voted to approve an amendment to our Series 1
Preferred Stock certificate of designations to provide for the automatic and immediate conversion
of each share of Series 1 Preferred stock into 2.247 shares of our Common Stock. The number of
shares of Common Stock these former holders of the Series 1 preferred stock received as a result of
this conversion was the same number of shares of Common Stock that these holders would have been
entitled to receive when, under the terms of the Series 1 preferred stock in effect immediately
prior to the conversion, the shares were to automatically convert to Common Stock on December 31,2008. The fair value of the additional shares paid to the then Series 1 Preferred stockholders was
approximately $2,247,000, which has been deducted from our net loss in arriving at net loss
attributable to Common Stock holders. In addition, notwithstanding the conversion, these former
holders of Series 1 preferred stock maintained their weighted average anti-dilution protection
through December 31, 2007. As a result of the registered direct offering of Common Stock, which
closed during the fourth quarter and in satisfaction of the weighted average anti-dilution
protection then in place, we issued to the former holders of Series 1 preferred stockholders
538,000 shares of common stock
We issued warrants to purchase 2,943,000 shares of common stock in connection with the registered
direct offering of units at an exercise price of $1.10 per share. These warrants expire on December20, 2012.
We issued warrants to purchase 3,054,000 shares of common stock in connection with the private
placement of Series 1 preferred stock at an exercise price of $1.66 per share, as adjusted during
the fourth quarter of 2007 for weighted average anti-dilution protection, to the placement agent of
our Series 1 Preferred Stock. These warrants expire on November 8, 2010 and contain weighted
average anti-dilution protection if we issue certain securities at a price per share less than
$1.66.
Stock-Based Compensation
We maintain equity compensation plans under which grants of incentive stock options, nonqualified
stock options, stock appreciation rights, stock awards, stock units and other stock-based awards
are granted to selected employees, non-employee directors and key advisors. Since our inception on
August 8, 2002, we have recognized equity compensation expense over the requisite service period
using the Black-Scholes-Merton formula to estimate the fair value of stock options. Beginning
January 1, 2006, we adopted SFAS No. 123(R) “Share-Based Compensation” under the
modified-prospective approach. The following table summarizes the total stock-based compensation
expense included in our Consolidated Statements of Operations (in thousands):
During the year ended December 31, 2007, approximately 1,345,000 stock options were awarded to
directors, officers and employees. As of December 31, 2007, there were 5,421,000 shares of Common
Stock issuable upon exercise of outstanding stock options and 112,000 shares of Common Stock
available for issuance of future equity compensation awards in connection with our equity
compensation plans.
Stock Options
As of December 31, 2007, there was approximately $1,820,000 of total unrecognized compensation cost
related to non-vested stock options, which will be amortized over the weighted average remaining
service period of approximately 1.15 years. This expected cost does not include the impact of any
future stock option awards. Options granted are generally exercisable for a period of up to ten
years from the date of grant at an exercise price which is not less than the fair value on the date
of grant and generally vest over terms ranging from immediately to four years. A summary of the
status of our stock options as of December 31, 2007 and changes during the year ended December 31,2007 is presented below (in thousands, except per share amounts):
The aggregate intrinsic value in the preceding tables represent the total pretax intrinsic value
that would have been received by the option holders had all option holders exercised their options
on the last day of 2007, 2006 and 2005, respectively. Intrinsic value is determined by calculating
the difference between the value of our stock on the last day of the year and the exercise price,
multiplied by the number of options.
The following table summarizes the fair value of options granted during the years ended December31, 2007, 2006 and 2005 and for the period from August 8, 2002 (Inception) to December 31, 2007,
respectively (in thousands, except per share amounts):
The fair value of options granted is amortized over the requisite service period. The fair value
of each option grant is estimated on the date of grant using the Black-Scholes-Merton formula with
the following weighted average assumptions:
Expected volatility and expected life for the years ended December 31, 2007, 2006 and 2005 were
estimated based upon historical activity, when available, and our benchmark analysis of selected
companies. The risk-free interest rate is calculated using the U.S. Treasury yield curves in
effect at the time of grant. We currently estimate that all of our outstanding options will vest.
Restricted Common Stock Grants
We have also issued shares of restricted common stock to selected employees, non-employee directors
and key advisors. As of December 31, 2007, there was no unrecognized compensation cost related to
non-vested restricted stock grants. This expected cost does not include the impact of any future
restricted common stock awards. The restriction period for restricted stock awards was for a four
year vesting period, commencing from the grant date.
The total grant date fair value of these awards was $34,000. All restricted shares awarded have
grant date fair values of $0.025 per share.
Common Stock Grants
We also issued common stock grants to selected employees, non-employee directors and key advisors.
For the years ended December 31, 2007, 2006 and 2005, and for the period from August 8, 2002
(Inception) to December 31, 2007, we issued common stock grants of 0, 30,000, 696,0000 and
1,244,000 shares, respectively. The fair value and expense recognized from the issuance of common
stock grants for the years ended December 31, 2007, 2006, and 2005 and for the period from August8, 2002 (Inception) to December 31, 2007, were $0, $45,000, $452,000, and $834,000, respectively.
Additionally, during 2007, we agreed to grant 50,000 shares of common stock as a one-time
termination benefit to certain empoloyees. These shares will be issued ratably over the first
five-months of 2008. We recognized $58,000 in equity based compensation costs associated with
these shares which is included in research and development costs on our Consolidated Statements of
Operations.
NOTE 7 — COMMITMENTS AND CONTINGENCIES
Capital Lease
We have entered into lease agreements for laboratory equipment. The initial obligation under these
capital leases was $331,000. The value of the laboratory equipment acquired in connection with
these leases was $398,000 and the depreciation associated with these assets is included along with
that of other owned property and equipment. These equipment leases have terms of up to three years,
at interest rates ranging from 9.5% to 11.5% and contain bargain purchase options. In connection
with these capital leases we paid the following (in thousands):
Our annual future lease payments under this capital lease are as follows (in thousands):
Principal
Interest
Total
2008
$
131
$
17
$
148
2009
104
4
108
Total minimum lease payments
$
235
$
21
$
256
Operating Lease
In June 2006, we entered into an operating lease agreement for 24,223 square feet of combined
office and laboratory space located in Radnor, Pennsylvania. The initial term of the lease is 12
years. Payments under the lease commenced on December 1, 2006. Our annual future minimum lease
payments under this non-cancelable operating lease are as follows (in thousands):
Operating Leases
2008
$
398
2009
497
2010
589
2011
667
2012
686
Thereafter
4,315
Total minimum lease payments
$
7,152
Prior to the commencement of our current operating lease for our Radnor Facility, we leased
approximately 3,500 square feet of combined office and laboratory space on a month-to-month basis
in Philadelphia, Pennsylvania. Rent expense was $598,000, $559,000 and $109,000 and $1,279,000 for
the years ended December 31, 2007, 2006, and 2005, and for the period from August 8, 2002
(Inception) to December 31, 2007, respectively.
Patent License Agreements
University of Pennsylvania. In January 2003, we entered into a Patent License Agreement with the
University of Pennsylvania, or Penn. Under the terms of the agreement, we were granted an
exclusive, worldwide royalty-bearing license to make and sell products utilizing seven of Penn’s
issued or pending patents for the life of such patents. One issued patent and five patent
applications cover the composition of matter on antimicrobial compounds, including small molecules,
oligomers and polymers. One patent application covers the composition and use of polycatonic
compounds for treating cancer. If a change-of-control event occurs, in which we transfer the
license to these patents to a third party, we are acquired by another company, or we conduct an
initial public offering of our securities, we are required to pay a 3% royalty on the gross sales
for licensed products that are sold as pharmaceuticals and a 1.5% royalty on products sold as
coatings for use in medical devices. We are permitted to sublicense the patents provided that (a)
the sublicensee is prohibited from further licensing of the patents and (b) the sublicensee is
subject to all of the terms of the original license granted to us. In addition, we are required to
share with Penn any consideration we receive from sublicensing our patents to a third party.
University of Massachusetts. We have entered a five-year sponsored research agreement with the
University of Massachusetts, or UMass. Under the terms of this agreement, we have the exclusive
option to license any intellectual property that may be generated by Dr. Gregory Tew pursuant to
research sponsored under the agreement. We may exercise this option by issuing 7,500 shares of our
common stock to UMass for each $100,000 of research conducted by Dr. Tew. If we exercise this
option, we are also required to reimburse UMass for direct patent costs incurred by it for the
patents licensed by us. During 2007, we issued 12,500 shares to UMass in connection with this
agreement. We sponsored $107,000 and $118,000 of Dr. Tew’s research for 2007 and 2006,
respectively.
Other
Agreements with Employees. We have entered into employment agreements with various executives.
These agreements provide for severance arrangements and accelerated vesting of equity compensation
awards in the event that the executive is terminated by us other than for cause or disability or if
the executive resigns or good reason.
Credit Line. In April 2006, we entered into a line of credit agreement with a financial
institution. This line of credit
provides for monthly interest-only payments at a variable per
annum rate of 3% plus the 30-day LIBOR rate. The
amount available under this line of credit ranges from 85% to 92% of cash and investments pledged
as collateral, based upon the amount and security type. There is currently no outstanding balance
on this line of credit. In June 2006, we entered into a letter of credit agreement with the same
financial institution to secure our payment obligations under our facility operating lease. This
letter of credit is for $1,400,000, expires on December 1, 2008 and is secured by our credit line.
Termination Benefits. During 2007, in connection with agreements with certain terminated employees,
we agreed to grant 50,000 shares of common stock as a one-time termination benefit to certain
employees. These shares will be issued ratably over the first five-months of 2008. We recognized
$58,000 in equity based compensation costs associated with these shares which is included in
research and development costs on our Consolidated Statements of Operations.
NOTE 8 — QUARTERLY FINANCIAL INFORMATION (UNAUDITED)
The following tables set forth certain unaudited financial information for each of the quarters in
the years ended December 31, 2007 and 2006. This unaudited quarterly information has been prepared
on the same basis as the audited financial statements and includes all necessary adjustments,
consisting only of normal recurring adjustments that we consider necessary for a fair presentation
of the unaudited quarterly results when read in conjunction with the audited financial statements
and notes. We believe that quarter-to-quarter comparisons of financial results are not necessarily
meaningful and should not be relied upon as an indication of future performance (in thousands,
except per share amounts).
Q1
Q2
Q3
Q4
Year
2007:
Grant and research
revenues
$
233
$
168
$
599
$
126
$
1,126
Operating expenses
2,351
3,595
3,686
4,169
*
13,801
Net loss
(1,949
)
(3,284
)
(2,973
)
(3,958
)*
(12,164
)
Net loss per common
share — basic and
diluted
$
(0.14
)
$
(0.24
)
$
(0.10
)
$
(0.14
)
$
(0.61
)
2006:
Grant and research
revenues
$
17
$
265
$
365
$
174
$
821
Operating expenses
1,487
1,751
1,921
2,321
7,480
Net loss
(1,379
)
(1,316
)
(1,326
)
(1,945
)
(5,966
)
Net loss per common
share — basic and
diluted
$
(0.13
)
$
(0.14
)
$
(0.13
)
$
(0.32
)
$
(0.72
)
*
includes adjustment of $439,000, which resulted from our change in estimated bonus accrual
F-17
Dates Referenced Herein and Documents Incorporated by Reference