0001144204-13-022048.txt : 20130416 0001144204-13-022048.hdr.sgml : 20130416 20130416143043 ACCESSION NUMBER: 0001144204-13-022048 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 27 CONFORMED PERIOD OF REPORT: 20121231 FILED AS OF DATE: 20130416 DATE AS OF CHANGE: 20130416 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Synthetic Biologics, Inc. CENTRAL INDEX KEY: 0000894158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133808303 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12584 FILM NUMBER: 13763569 BUSINESS ADDRESS: STREET 1: 155 GIBBS STREET STREET 2: SUITE 412 CITY: ROCKVILLE STATE: MD ZIP: 20850 BUSINESS PHONE: (734) 332-7800 MAIL ADDRESS: STREET 1: 155 GIBBS STREET STREET 2: SUITE 412 CITY: ROCKVILLE STATE: MD ZIP: 20850 FORMER COMPANY: FORMER CONFORMED NAME: ADEONA PHARMACEUTICALS, INC. DATE OF NAME CHANGE: 20081027 FORMER COMPANY: FORMER CONFORMED NAME: PIPEX PHARMACEUTICALS, INC. DATE OF NAME CHANGE: 20061214 FORMER COMPANY: FORMER CONFORMED NAME: SHEFFIELD PHARMACEUTICALS INC DATE OF NAME CHANGE: 19970730 10-K 1 v337358_10k.htm 10-K

 

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

 

Washington, DC 20549

  

FORM 10-K

  

x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the fiscal year ended December 31, 2012

 

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934

 

For the transition period from______________________ to____________________________

 

Commission File Number: 1-12584

 

 

SYNTHETIC BIOLOGICS, INC.

(Name of small business issuer in its charter)

 

Nevada 13-3808303
(State or other jurisdiction of incorporation or organization) (IRS Employer Identification Number)
   
155 Gibbs Street, Suite 412  
Rockville, MD 20850
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code:

(734) 332-7800

 

Securities registered pursuant to Section 12(b) of the Act: Name of each exchange on which registered
(Title of Class)  
Common Stock, $0.001 par value per share NYSE MKT

 

Securities registered pursuant to Section 12(g) of the Act:

None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  Yes  ¨   No  x

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.  Yes ¨ No  x

 

Indicate by check mark whether the issuer: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  x No  ¨

 

Indicate by check mark 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 issuer’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.    x

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every interactive data file required to be submitted and posted pursuant to Rule 405 of Regulation S-T (section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).Yes   x   No ¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated file, a non-accelerated file, 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):

 

  Large accelerated filer ¨ Accelerated filer                    ¨  
  Non-accelerated filer ¨ Smaller reporting company   x  
         
  (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 Exchange Act).   Yes  ¨   No  x

 

The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant as of June 30, 2012, was approximately $44,969,000 based on $1.98, the price at which the registrant’s common stock was last sold on that date.

 

As of March 27, 2013, the issuer had 44,654,414 shares of common stock outstanding.

 

Documents incorporated by reference: None.

 

 
 

 

SYNTHETIC BIOLOGICS, INC.

  

FORM 10-K

TABLE OF CONTENTS

 

      Page
       
    PART I.  
Item 1.   Business 3
Item 1A.   Risk Factors 14
Item 1B.   Unresolved Staff Comments 24
Item 2.   Properties 24
Item 3.   Legal Proceedings 24
Item 4.   Mine Safety Disclosures 24
       
    PART II.  
Item 5.   Market for Registrant’s Common Equity Related Stockholder Matters and Issuer Purchases of Equity Securities 25
Item 6.   Selected Financial Data 25
Item 7.   Management’s Discussion and Analysis of Financial Condition and Results of Operations 26
Item 7A.   Quantitative and Qualitative Disclosures About Market Risk 32
Item 8.   Financial Statements and Supplementary Data 33
Item 9.   Changes in and Discussions with Accountants on Accounting and Financial Disclosure 52
Item 9A.   Controls and Procedures 52
Item 9B.   Other Information 52
       
    PART III.  
Item 10.   Directors, Executive Officers and Corporate Governance 53
Item 11.   Executive Compensation 55
Item 12.   Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 58
Item 13.   Certain Relationships and Related Transactions, and Director Independence 59
Item 14.   Principal Accountant Fees and Services 59
       
    PART IV.  
Item 15.   Exhibits and Financial Statement Schedules 61
SIGNATURES 65
GLOSSARY  

 

2
 

 

PART I

 

Forward-Looking Statements

 

Most of the matters discussed within this report include forward-looking statements on our current expectations and projections about future events. In some cases you can identify forward-looking statements by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based on our current beliefs, expectations, and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and generally beyond our control, that could cause actual results to differ materially from those expressed, projected or implied in or by the forward-looking statements. Such risks and uncertainties include the risks noted under “Item 1A Risk Factors.” We do not undertake any obligation to update any forward-looking statements. Unless the context requires otherwise, references to “we,” “us,” “our,” and “Synthetic Biologics,” refer to Synthetic Biologics, Inc. and its subsidiaries.

 

Item 1.            Business

 

We are a biotechnology company focused on the development of biologics for the prevention and treatment of serious infectious diseases. We are developing an oral enzyme for the prevention of C. difficile infections, and a series of monoclonal antibody therapies for the treatment of Pertussis and Acinetobacter infections. In addition, we are developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis and cognitive dysfunction in multiple sclerosis, and have partnered the development of a treatment for fibromyalgia.

 

Product Pipeline:

 

 

Summary of Infectious Disease Programs:

 

•Clostridium difficile (C. difficile) infections: In November 2012, we acquired a series of oral beta-lactamase enzymes (P1A, P2A and P3A) and related assets targeting the prevention of C. difficile infections (CDI), the leading cause of hospital acquired infections (HAI), that generally occurs secondary to treatment with intravenous antibiotics. The acquired assets include a pre-Investigational New Drug (IND) package for P3A (SYN-004), Phase I and Phase II clinical data for P1A, manufacturing processes and data, and a portfolio of issued and pending U.S. and international patents intended to support an IND and Biologic License Application (BLA) with the FDA. Utilizing this portfolio of assets, we intend to develop a proprietary oral beta-lactamase enzyme product candidate, SYN-004, previously known as IPSAT P3A. When co-administered with certain intravenous beta-lactam antibiotics, it is expected that SYN-004 can degrade the antibiotic that is excreted in the gastrointestinal (GI) tract, thus preserving the natural balance of the patient's microflora, and preventing opportunistic infections including CDI. Beta-lactam antibiotics are a mainstay in hospital infection management and include the commonly used penicillin and cephalosporin classes of antibiotics. According to GlobalData, an estimated 8.7 million Americans were administered intravenous beta-lactam antibiotics in 2011.

  

3
 

  

•Pertussis: In December 2012, in collaboration with Intrexon Corporation (Intrexon), we initiated development of a monoclonal antibody (mAb) therapy for the treatment of Pertussis infections, more commonly known as whooping cough. We are developing a mAb therapy, SYN-005, designed to target and neutralize the pertussis toxin, in order to reduce the mortality rate in infants and potentially shorten the duration of chronic cough in afflicted adults. To further the development of this potential therapy for Pertussis, we entered into an agreement with The University of Texas at Austin to license the rights to certain research and pending patents related to pertussis antibodies. According to the World Health Organization, each year, B. pertussis infection causes an estimated 294,000 deaths worldwide, primarily among young, unvaccinated children.

 

•Acinetobacter infections: In September 2012, in collaboration with Intrexon, we initiated efforts to develop a mAb therapy for the treatment of Acinetobacter infections. Many strains of Acinetobacter are multidrug-resistant and pose an increasing global threat to hospitalized patients, wounded military personnel and those affected by natural disasters. A treatment for Acinetobacter infections represents a multi-billion dollar market opportunity.

 

Summary of Multiple Sclerosis Program:

 

•TrimestaTM (oral estriol) is being developed as an oral once-daily treatment for relapsing-remitting multiple sclerosis (MS) in women. Patient enrollment is complete in this two-year, randomized, double-blind, placebo-controlled Phase II clinical trial being conducted at 15 centers in the U.S. The primary endpoint is relapse rate at two years, with top-line results expected in 1H 2014. This trial is supported by grants exceeding $8 million, which should be sufficient to fund the trial through completion. Current sales of injectable disease-modifying therapies for MS are estimated at $8.9 billion annually.

 

•TrimestaTM is also being developed for the treatment of cognitive dysfunction in female MS patients. This 12-month randomized, double-blind, placebo-controlled Phase II clinical trial being conducted at University of California, Los Angeles (UCLA). The primary endpoint is the effect on cognitive function as assessed by Paced Auditory Serial Addition Test (PASAT). Patient enrollment is ongoing. The majority of the costs of this trial are being funded by grants from foundations and charitable organizations and we have pledged approximately $500,000 to UCLA to partially fund this trial payable over three years. An estimated 50-65% of MS patients are expected to develop disabilities due to cognitive dysfunction and there is currently no approved treatment.

 

Summary of Fibromyalgia Program:

 

•EffirmaTM (flupirtine) is being developed for the treatment of fibromyalgia by Meda AB (Meda), a multi-billion dollar international pharmaceutical company. On May 6, 2010, we entered into a sublicense agreement with Meda covering all of our patents’ rights on the use of flupirtine for fibromyalgia in the U.S., Canada and Japan. The sublicense agreement provides that all ongoing and future development costs are to borne by Meda and we are entitled to receive certain payments if milestones are achieved and royalties on sales. According to Meda’s 2012 Year-End Report filed in February 2013, Meda has received the go-ahead from the FDA to conduct a Phase II proof of concept study for the treatment of fibromyalgia. Meda also announced that the randomized, double-blind, placebo and active-controlled study of patients with fibromyalgia will be conducted at 25 clinics in the U.S. Based on an estimated annual price of $1,200 per fibromyalgia patient, we estimate that the total market potential in the U.S. is $6 billion.

  

To prioritize our focus on the development of product candidates for the prevention and treatment of serious infectious diseases, we do not intend to pursue further development of our previously announced program for pulmonary arterial hypertension. However, we are currently in discussions with Intrexon to substitute this program with an alternate program better suited to our current objectives and focus.

 

In order to further prioritize our focus, we have elected to discontinue further development of AEN-100 for the treatment of amyotrophic lateral sclerosis. However, we are currently seeking development partners for our zinc-based intellectual property and assets including, AEN-100.

 

Pipeline Programs and Therapeutic Areas

 

Infectious Disease Programs

 

We are focused on the development of biologics for the prevention and treatment of serious infectious diseases. Infectious disease outbreaks are increasing while intervention options are declining due to widespread multidrug-resistant bacteria, increasing numbers of immuno-compromised patients (eg. the elderly and cancer patients), and the isolation of new pathogens. We are developing an oral enzyme for the prevention of C. difficile infections, and a series of monoclonal antibody therapies for the treatment of Pertussis and Acinetobacter infections.

 

4
 

 

C. difficile Infections:

 

According to the Agency for Healthcare Research and Quality, aggregate costs associated with CDI-related stays in the hospital were $8.2 billion in the U.S. during 2009. CDI is a rising global HAI problem in which the toxins produced by C. difficile bacteria result in diarrhea (C. difficile-associated diarrhea (CDAD)), and in the most serious cases, pseudomembranous colitis (erosion of the lower GI tract) that can lead to death. CDI is a major, unintended risk associated with the prophylactic or therapeutic use of intravenous antibiotics, which may alter the natural balance of microflora that normally protect the GI tract, leading to C. difficile overgrowth and infection. Other risk factors for CDI include hospitalization, prolonged length of stay, underlying illness, immune-compromising conditions including the administration of chemotherapy, and advanced age.

 

CDI is a widespread and often drug resistant infectious disease, resulting in more than 337,000 hospitalizations and 30,000 deaths in the U.S. during 2009, according to the U.S. Department of Health & Human Services. CDI has surpassed methicillin-resistant staphylococcus aureus (MRSA) as the most frequent infection acquired in the hospital. It has recently been reported by The Centers for Disease Control and Prevention that the current number of CDI cases may be as high as 500,000 annually in the U.S. Controlling the spread of CDI has proven challenging, as the C. difficile spores are easily transferred to patients via normal contact with healthcare personnel and other inanimate objects. There is currently no vaccine or approved product for the prevention of C. diff infection.

 

C. difficile: Acquisition of Clinical-Stage Program

 

In November 2012, we acquired a series of oral beta-lactamase enzymes (P1A, P2A and P3A) and related assets targeting the prevention CDI, the leading cause of HAIs, that generally occurs secondary to treatment with intravenous antibiotics. The acquired assets include a pre-IND package for P3A (SYN-004), Phase I and Phase II clinical data for P1A, manufacturing processes and data, and a portfolio of issued and pending U.S. and international patents intended to support an IND and BLA with the FDA. Utilizing this portfolio of assets, we intend to develop a proprietary oral beta-lactamase enzyme product candidate, SYN-004, previously known as IPSAT P3A. When co-administered with certain intravenous beta-lactam antibiotics, it is expected that SYN-004 can degrade the antibiotic that is excreted in the GI tract, thus preserving the natural balance of the patient's microflora, and preventing opportunistic infections including CDI. Beta-lactam antibiotics are a mainstay in hospital infection management and include the commonly used penicillin and cephalosporin classes of antibiotics. According to GlobalData, an estimated 8.7 million Americans were administered intravenous beta-lactam antibiotics in 2011.

 

C. difficile: Oral Enzyme Background

 

We acquired a series of oral beta-lactamase enzymes (P1A, P2A and P3A). Beta-lactamase enzymes have the ability to degrade beta-lactam antibiotics that may be excreted into the GI tract. P1A (the first generation candidate) showed acceptable safety and tolerability in a Phase I study. In addition, two Phase II clinical studies demonstrated that P1A had the ability to preserve GI microflora in hospitalized patients treated with intravenous ampicillin or the combination of piperacillin and tazobactam.

 

C. difficile: Clinical Development

 

Compared to the first generation oral enzyme candidate, P1A, we believe that SYN-004 (formerly P3A) will have activity against a broader spectrum of beta-lactam antibiotics, including both penicillins and most cephalosporins. Due to the structural similarities between P1A and SYN-004 for the prevention of CDI, along with previous discussions with the FDA, it is anticipated that certain preclinical data collected on P1A may be used in support of an IND for our new product candidate, SYN-004.

 

Monoclonal Antibodies:

 

Monoclonal Antibodies for Infectious Diseases

 

Acting as the body's army, antibodies are proteins, generally found in the bloodstream, that provide immunity in detecting and destroying pathogens, such as viruses and bacteria and their associated toxins. MAbs can also be designed and produced as therapeutic agents, utilizing protein engineering and recombinant production technologies. The mAbs being developed under our collaboration with Intrexon are intended to supplement a patient's own immune system by providing the means to specifically and rapidly neutralize and/or clear specific pathogens and toxins of interest in a process known as “passive immunity”. Many pathogens that cause infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs.

 

Intrexon Collaboration: Monoclonal Antibodies for Infectious Diseases

 

In August 2012, we entered into a worldwide exclusive channel collaboration with Intrexon through which we intend to develop a series of mAb therapies for the treatment of certain infectious diseases not adequately addressed by existing therapies. Utilizing Intrexon’s comprehensive suite of proprietary technologies, including the mAbLogix™ platform for rapid discovery of fully human mAbs and the LEAP™ cell processing station, our initial efforts will target three infectious disease indications. We also have the option to target an additional five infectious disease indications under this collaboration. To date, we have initiated development of a mAb therapy for the treatment of Pertussis and Acinetobacter infections.

 

(mAbLogixTM and LEAPTM are registered trademarks of Intrexon Corporation)

 

5
 

 

Pertussis (Whooping Cough):

 

Bordetella pertussis (B. pertussis) is a gram-negative bacterium that infects the upper respiratory tract, causing uncontrollable, violent coughing. Antibiotic treatment does not have a major effect on the course of Pertussis, because while it can eliminate the B. pertussis bacteria from the respiratory tract, it does not neutralize the pertussis toxin. Infants with Pertussis often require hospitalization in pediatric intensive care units, frequently requiring mechanical ventilation. Pertussis in adults generally leads to a chronic cough referred to as the "cough of 100 days." The incidence of Pertussis is increasing in association with exposure of unvaccinated and under-vaccinated individuals including infants who are not yet fully vaccinated, exposure of individuals whose immunity has diminished over time, as well as asymptomatic carriers.

 

According to the World Health Organization, each year, B. pertussis infection causes an estimated 294,000 deaths worldwide, primarily among young, unvaccinated children. Recent news reports throughout the U.S. indicate that the pertussis vaccine introduced in the 1990s does not provide long-term protection and, as a result, whooping cough cases are increasing to a 60-year high. There is no approved treatment for Pertussis, and antibiotic treatment does not have a major effect on the course of Pertussis, because while it can eliminate the B. pertussis bacteria from the respiratory tract, it does not neutralize the pertussis toxin.

 

Pertussis: Intrexon Collaboration and The University of Texas at Austin Agreement

 

In December 2012, we initiated mAb development for the treatment of Pertussis focusing on toxin neutralization pursuant to our August 2012 collaboration with Intrexon. Unlike antibiotics, we are developing a mAb therapy, SYN-005, to target and neutralize the pertussis toxin, in order to reduce the mortality rate in infants and potentially shorten the duration of chronic cough in afflicted adults. SYN-005 is currently in preclinical studies.

 

To further the development of this potential therapy for pertussis, we have entered into an agreement with The University of Texas at Austin to license the rights to certain research and pending patents related to pertussis antibodies. These research efforts are being conducted at the Cockrell School of Engineering in the laboratory of Assistant Professor, Jennifer A. Maynard, Ph.D., the Laurence E. McMakin, Jr. Centennial Faculty Fellow in the McKetta Department of Chemical Engineering. Dr. Maynard brings to the project her expertise in defining the key neutralizing epitopes of pertussis toxin to optimize the potential efficacy of antibody therapeutics.

 

Acinetobacter Infections:

 

Acinetobacter baumanii is a difficult to treat pathogen due to its rapid and well-established development of resistance to most antibiotics, making it a multidrug-resistant pathogen. In addition, as a biofilm-forming pathogen, Acinetobacter baumanii has the ability to survive up to twice as long as non-biofilm-forming pathogens. In the U.S., Acinetobacter baumanii has been reported to be the cause of up to 2.6% of hospital acquired infections, 1.3% of bloodstream infections and 7% of ICU respiratory tract infections, and more than half of the Acinetobacter baumanii isolates are multidrug-resistant. According to published articles, mortality rates as high as 43% are reported in hospital and ICU settings. While Acinetobacter baumanii is a well-documented pathogen in the hospital setting, this pathogen also poses an increasing danger to wounded servicemen and women in military treatment centers and to those treated in trauma centers following natural disasters.

 

A treatment for Acinetobacter infections represents a multi-billion dollar market opportunity.

 

Acinetobacter: Intrexon Collaboration

 

In August 2012, we initiated a mAb discovery and development program for Acinetobacter infections pursuant to our August 2012 collaboration with Intrexon. Discovery efforts for the development of a mAb are currently underway.

 

Multiple Sclerosis Program

 

Relapsing-Remitting MS in Women:

 

MS is a progressive neurological disease in which the body loses the ability to transmit messages along central nervous system nerve cells, leading to pain, loss of muscle control, paralysis, cognitive impairment and in some cases death. According to the National Multiple Sclerosis Society (NMSS), more than 2.5 million people worldwide (approximately 400,000 patients in the U.S. of which approximately 70% are women) have been diagnosed with MS. The diagnosis is typically made in young adults, ages 20 to 50. According to the NMSS, approximately 85% of MS patients are initially diagnosed with the relapsing-remitting form, and 10-15% with other progressive forms.

 

There are ten FDA-approved therapies for the treatment of relapsing-remitting MS: Betaseron®, Rebif®, Avonex®, Novantrone®, Copaxone®, Tysabri®, Gilenya®, Extavia®, Aubagio® and TecfideraTM. Many of these therapies provide only a modest benefit for patients with relapsing-remitting MS. All of these drugs except Gilenya® and TecfideraTM require frequent (daily, weekly & monthly) injections (or infusions) on an ongoing basis and can be associated with unpleasant side effects (such as flu-like symptoms) and high rates of non-compliance among users. Despite the availability of therapies for the treatment of relapsing-remitting MS, the disease is highly underserved and exacts a heavy personal and economic toll.

 

6
 

 

Current sales of injectable disease-modifying therapies for MS are estimated at $8.9 billion annually.  According to various reports, sales of oral disease-modifying therapies for MS, such as Trimesta, if and when approved, are anticipated to grow from $500 million in 2010 to in excess of $5 billion annually by 2017.

 

Relapsing-Remitting MS: Background

 

Research has shown that pregnant women with MS tend to experience a spontaneous reduction of disease symptoms during pregnancy, particularly in the third trimester. The PRIMS (Pregnancy In MS) study, a landmark clinical study published in the New England Journal of Medicine followed 254 women with MS during 269 pregnancies and for up to one year after delivery. The PRIMS study demonstrated that relapse rates were significantly reduced by 71% (p < 0.001) through the third trimester of pregnancy compared to pre-pregnancy-rates, and that relapse rates increased by 120% (p < 0.001) during the first three months after birth (post-partum) and then return to pre-pregnancy rates. It has been hypothesized that the female hormone, estriol, produced by the placenta during pregnancy, plays a role in “fetal immune privilege”, a process that prevents a mother’s immune system from attacking and rejecting the fetus. The maternal levels of estriol increase linearly through the third trimester of pregnancy until birth, whereupon it abruptly returns to low circulating levels. The anti-autoimmune effects of estriol are thought to be responsible for the therapeutic effects of pregnancy on MS.

 

Rhonda Voskuhl, M.D., Director, UCLA MS program, UCLA Department of Neurology, has found that plasma levels of estriol achieved during pregnancy have potent immunomodulatory effects. She further postulated and tested in a pilot clinical study that oral doses of estriol may have a therapeutic benefit when administered to non-pregnant female MS patients by, in essence, mimicking the spontaneous reduction in relapse rates seen in MS patients during pregnancy.

 

Estriol has been approved and marketed for over 40 years throughout Europe and Asia for the oral treatment of post-menopausal symptoms. It has never been approved by the U.S. FDA for any indication.

 

Relapsing-Remitting MS: Clinical Development

 

Trimesta (oral estriol) is being developed for the treatment of relapsing-remitting MS in women. An investigator-initiated, 10-patient, 22-month, single-agent, crossover clinical trial to study the therapeutic effects of 8 mg of oral Trimesta taken daily in non-pregnant female relapsing-remitting MS patients was completed in the U.S. The total volume and number of gadolinium-enhancing lesions were measured by brain magnetic resonance imaging (an established neuroimaging measure of disease activity in MS). Over the next three months of treatment with Trimesta, the median total enhancing lesion volumes decreased by 79% (p = 0.02) and the number of lesions decreased by 82% (p = 0.09). They remained decreased during the next 3 months of treatment, with lesion volumes decreased by 82% (p = 0.01), and numbers decreased by 82% (p =0.02). Following a six-month drug holiday during which the patients were not on any drug therapies, median lesion volumes and numbers returned to near baseline pretreatment levels. Trimesta therapy was reinitiated during a four-month retreatment phase of this clinical trial. The relapsing-remitting MS patients again demonstrated a decrease in enhancing lesion volumes of 88% (p = 0.008) and a decrease in the number of lesions by 48% (p = 0.04) compared with original baseline scores.

 

A Phase II randomized, double-blind, placebo-controlled clinical trial is currently underway at 15 centers in the U.S. under the direction of Lead Principal Investigator, Dr. Rhonda Voskuhl. The purpose of this clinical trial is to evaluate whether 8 mg of oral Trimesta taken daily over a two year period will reduce the rate of relapses in a large population of female patients with relapsing-remitting MS. Investigators are administering either Trimesta or matching placebo, in addition to a standard of care, glatiramer acetate injections (Copaxone®), an FDA-approved therapy for MS, to women between the ages of 18 to 50 who have been recently diagnosed with relapsing-remitting MS. Relapse rates at two years is the primary endpoint in this clinical trial being run under an investigator-initiated IND. As of January 23, 2012, 164 patients have been enrolled and enrollment has been closed. The patients will be dosed and monitored for two years with the last patient scheduled to complete two years of therapy in January 2014.

 

With over $8 million in grant funding to date, the ongoing Trimesta clinical trial should be funded to its completion.

 

Cognitive Dysfunction in MS:

 

According to the NMSS and the Multiple Sclerosis Society of Canada publication, Hold that Thought! Cognition and MS, it is fairly common for people with MS to complain of cognitive difficulties, such as remembering things, finding the right words and the ability to concentrate. Among MS patients, 50-65% have some degree of cognitive dysfunction.

 

The major areas of cognition that may be affected include complex attention and executive functions. Complex attention involves multitasking, the speed with which information can be processed, learning and memory, and perceptual skills; executive functions include problem solving, organizational skills, the ability to plan, and word finding. Just as the nature, frequency, and severity of MS-related physical problems can widely vary, not all people with MS will have cognitive dysfunction, and no two people will experience exactly the same type or severity.

 

7
 

 

Cognitive Dysfunction in MS: Background

 

In the investigator-initiated, 10-patient, 22-month, single-agent, crossover clinical trial conducted by Dr. Rhonda Voskuhl, a statistically significant 14% improvement from baseline in the PASAT cognitive testing scores (p = 0.04) was observed in relapsing-remitting MS patients after six months of Trimesta therapy. PASAT is a routine cognitive test performed in patients with a wide variety of neuropsychological disorders such as MS. The PASAT scores are expressed as a mean percent change from baseline.

 

Cognitive Dysfunction in MS: Clinical Development

 

Our Trimesta (oral estriol) drug candidate is also being developed for the treatment of cognitive dysfunction in female MS patients. This randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate Trimesta’s potential neuroprotective and therapeutic effect on cognitive dysfunction in female MS patients is currently enrolling relapsing-remitting or secondary-progressive female MS patients at UCLA. Up to 64 patients between the ages of 18 and 50 will be randomized 1:1 into the treatment and placebo groups. Dr. Voskuhl will administer either oral Trimesta or a matching placebo, in addition to any FDA-approved MS treatment. Each patient will be dosed and monitored for one year after being enrolled. The primary endpoint in this clinical trial being run under an investigator-initiated IND application is expected to be improvement in PASAT cognitive testing scores versus matching placebo. We and a private foundation have pledged to equally support this new clinical trial, and we will also provide Trimesta drug supply. The trial also received contributions from several other supporters. Patient recruitment and enrollment into this trial is ongoing.

 

Fibromyalgia Program

 

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, often accompanied by severe fatigue, insomnia and alterations in mood. According to the National Fibromyalgia Association, fibromyalgia affects an estimated 3-6% of the population worldwide, including an estimated 10 million people in the U.S. There are presently three FDA products approved for the treatment of fibromyalgia – Lyrica®, Cymbalta® and Savella®.

 

Based on an estimated annual price of $1,200 per fibromyalgia patient, we estimate that the total market potential in the U.S. is $6 billion.

 

Fibromyalgia: Meda Corporate Partnership

 

On May 6, 2010, we entered into a sublicense agreement with Meda, a multi-billion dollar international pharmaceutical company, pursuant to which Meda assumed all future development costs and may commercialize flupirtine, a molecular entity with a unique mode of action for the treatment fibromyalgia in the U.S. As consideration for such sublicense, we received an up-front payment of $2.5 million and are entitled to milestone payments of $5 million upon the FDA’s acceptance of the New Drug Application (NDA) for flupirtine for fibromyalgia and $10 million upon FDA approval of such NDA. Pursuant to the sublicense agreement, we will also receive a 7% royalty on net sales of flupirtine for fibromyalgia in the U.S., Canada and Japan, with such royalties being shared equally with our licensor, McLean Hospital, a Harvard teaching hospital.

 

Flupirtine is approved and marketed by Meda and its distributors in Europe and other countries for indications other than fibromyalgia and has been prescribed to millions of patients worldwide. We believe that such substantial human experience with flupirtine should greatly assist the FDA in its evaluation of the safety of flupirtine upon review of an NDA of flupirtine for fibromyalgia.

 

Fibromyalgia: Clinical Development

 

Our Effirma (flupirtine) drug candidate for the treatment of fibromyalgia, has been partnered to Meda (see “Fibromyalgia: Meda Corporate Partnership” section above). Effirma is a selective neuronal potassium channel opener that also has NMDA receptor antagonist properties. Effirma is a non-opioid, non-NSAID, non-steroidal, analgesic. Preclinical data and clinical experience suggest that Effirma should also be effective for neuropathic pain since it acts in the central nervous system via a mechanism of action distinguishable from most marketed analgesics. Effirma is especially attractive because it operates through non-opiate pain pathways, exhibits no known abuse potential, and lacks withdrawal effects. In addition, no tolerance to its antinocioceptive effects has been observed. One common link between neuroprotection, nocioception and Effirma may be the N-methyl-D-aspartic acid glutamate system, a major receptor subtype for the excitotoxic neurotransmitter, glutamate. Effirma has strong inhibitory actions on N-methyl-D-aspartic acid-mediated neurotransmission. Flupirtine was originally developed by Asta Medica (subsequently acquired by Meda) and has been approved and is marketed by Meda in Europe since 1984, as well as other countries, for the treatment of pain. It has never been approved by the FDA for any indication.

 

According to Meda’s 2012 Year-End Report filed in February 2013, Meda has received the go-ahead from the FDA to conduct a Phase II proof of concept study for the treatment of fibromyalgia. Meda also announced that the randomized, double-blind, placebo and active-controlled study of patients with fibromyalgia will be conducted at 25 clinics in the U.S.

 

Intellectual Property

 

Our goal is to (a) obtain, maintain, and enforce patent protection for our products, formulations, processes, methods, and other proprietary technologies, (b) preserve our trade secrets, and (c) operate without infringing on the proprietary rights of other parties, worldwide. We seek, where appropriate, the broadest intellectual property protection for product candidates, proprietary information, and proprietary technology through a combination of contractual arrangements and patents. Below is a description of our license and development agreements relating to our product candidates.

 

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The University of Texas at Austin License Agreement and Sponsored Research Agreement

 

On December 19, 2012, we entered into a Patent License Agreement (the “Texas License Agreement”) with The University of Texas at Austin (the “University”) for the exclusive license of the right to use, develop, manufacture, market and commercialize certain research and patents related to pertussis antibodies developed in the lab of Dr. Jennifer A. Maynard, Assistant Professor of Chemical Engineering. The Texas License Agreement provides that the University is entitled to payment of past patent expenses, an annual payment of $50,000 per year commencing on the effective date through December 31, 2014 and a $25,000 payment on December 31, 2015 and milestone payments of $50,000 upon commencement of Phase I Clinical Trials, $100,000 upon commencement of Phase III Clinical Trials, $250,000 upon NDA submission in the United States, $100,000 upon European Medicines Agency approval and $100,000 upon regulatory approval in an Asian country. In addition, the University is entitled to a running royalty upon Net Product Sales and Net Service Sales (as defined in the Texas License Agreement). The License Agreement terminates upon the expiration of the patent rights (as defined in the Texas License Agreement); provided, however that the Texas License Agreement is subject to early termination by us in our discretion and by the University for a breach of the Texas License Agreement by us.

 

In connection with the Texas License Agreement, we also entered into a Sponsored Research Agreement (the “Sponsored Research Agreement”) with the University pursuant to which the University will perform certain research work related to pertussis under the direction of Dr. Jennifer Maynard and we will obtain certain rights to patents and technology developed during the course of such research. All inventions conceived during such research shall be subject to the Texas License Agreement. The Sponsored Research Agreement may be renewed annually, in our sole discretion, after the first year for two additional one year terms with a fixed fee for the first year of $303,287 and for the second and third years, if renewed, a fixed fee of $316,438 and $328,758 respectively, all payable in quarterly installments. If renewed by us after the first year for the remaining two years, the research shall be performed from the effective date of the Sponsored Research Agreement until December 31, 2015; provided, however, the Sponsored Research Agreement is subject to early termination upon the written agreement of the parties, a default in the material obligations under the Sponsored Research Agreement which remain uncured for sixty days after receipt of notice, automatically upon our bankruptcy or insolvency and by us in our sole discretion at any time after the one year anniversary of the date of execution thereof upon no less than 90 days notice. Upon termination prior to December 31, 2014, we shall only be responsible for payment of expenses that do not exceed the fixed annual amount and are incurred prior to the termination date and non-cancellable expenses committed to be expended by the University prior to the termination date for the lesser of the remainder of their appointment in the case of salaries and December 31, 2014. Upon a termination after December 31, 2014 or due to a breach by the University, we shall only be responsible for all reasonable expenses that do not exceed the fixed annual amount and that are incurred by the University prior to the termination date for services performed prior to the termination date.

 

Oral Enzyme for C. difficile Program Acquisition Agreement

 

On November 8, 2012, we entered into an Asset Purchase Agreement (the “Prev Agreement”) with Prev ABR LLC (“Prev”), and subsequently closed the transaction on November 28, 2012. Pursuant to the Prev Agreement we acquired the C. difficile program assets of Prev, including pre-IND package for P3A (SYN-004), Phase I and Phase II clinical data for P1A, manufacturing processes and data, and a portfolio of issued and pending U.S. and international patents intended to support an IND and BLA with the FDA. Pursuant to the Prev Agreement, we paid Prev an initial cash payment of $100,000 upon execution of the Prev Agreement and at closing paid an additional cash payment of $135,000 and issued 625,000 unregistered shares of our common stock to Prev. In addition, upon the achievement of the milestones set forth below, Prev may be entitled to receive additional consideration payable 50% in cash and 50% in our stock, subject to Prev’s option to receive the entire payment in shares of our stock, with the exception of the first milestone payments to be paid in cash: (i) upon commencement of an IND; (ii) upon commencement of a Phase I clinical trial; (iii) upon commencement of a Phase II clinical trial; (iv) upon commencement of a Phase III clinical trial; (v) upon Biologic License Application (BLA) filing in the U.S. and for territories outside of the U.S. (as defined in the Prev Agreement); and (vi) upon BLA approval in the U.S. and upon approval in territories outside the U.S. The future stock issuances are subject to prior approval of the NYSE MKT, LLC. No royalties are payable to Prev under the Prev Agreement.

 

The Prev Agreement also provides that Prev has a right to the return to it of all assets acquired by us under the Prev Agreement if on or prior to the date that is (i) thirty (30) months after the execution of the Prev Agreement, we have not initiated toxicology studies in non-rodent models or (ii) thirty six (36) months have not filed an IND under the program related to the assets and such failure is not due to action or inaction of Prev or breach of its representations or warranties or covenants or if there is a change of control as defined in the Prev Agreement and after such change of control the assets are not further developed; provided however that such thirty (30) and thirty six (36) month periods can be extended by us for an additional twelve (12) months upon payment of a cash milestone payment.

 

Infectious Disease Collaboration with Intrexon

 

On August 6, 2012, we expanded our relationship with Intrexon and entered into a second Exclusive Channel Collaboration Agreement (the “Second Channel Agreement”) with Intrexon that governs a “channel collaboration” arrangement in which we will use Intrexon’s technology relating to the identification, design and production of human antibodies and DNA vectors for the development and commercialization of a series of monoclonal antibody therapies for the treatment of certain serious infectious diseases the “Program”) for the treatment of eight specific target infectious disease indications (the “Field”). Initially, our development efforts will target three infectious diseases within the Field. Within the first two years of the collaboration, we have the right to exchange our initial three targets on a one-for-one basis with any of the other five targeted infectious diseases in the Field at no additional cost. We also have the option, within such two year period, to choose to develop any or all of the other five target diseases in the Field, upon payment of the additional consideration described below. Such license is exclusive with respect to any clinical development, selling, offering for sale or other commercialization of our products within the Field (“Synthetic Products”), and otherwise is non-exclusive. We may not sublicense the rights described without Intrexon’s written consent. Under the Second Channel Agreement, and subject to certain exceptions, we are responsible for, among other things, the performance of the Program including the development, commercialization and manufacturing of products.

 

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Subject to certain expense allocations and other offsets provided in the Second Channel Agreement, we will pay Intrexon royalties on annual net sales of the Synthetic Products, calculated on a Synthetic Product-by-Synthetic Product basis. We have likewise agreed to pay Intrexon a percentage of quarterly revenue obtained from a sublicensor in the event of a sublicensing arrangement.

 

During the first 18 months, we may not terminate the Second Channel Agreement, except under limited circumstances. Following the first 18 months, we may voluntarily terminate the Second Channel Agreement upon 90 days written notice to Intrexon.  Intrexon may also terminate the Second Channel Agreement if we elect not to pursue the development of a Program identified by Intrexon that is a “Superior Therapy” as defined in the Second Channel Agreement upon 60 days notice unless we remedy the circumstances giving rise to the termination during such notice period. Each party has the right to terminate the agreement upon 60 days notice if the other party commits a material breach of the Second Channel Agreement, subject to certain cure periods.

 

Upon termination of the Second Channel Agreement, we may continue to develop and commercialize any Synthetic Product that, at the time of termination satisfies one of the following:

 

•is being commercialized by us,
•has received regulatory approval,
•is a subject of an application for regulatory approval that is pending before the applicable regulatory authority,
•is a subject of at least a Phase 2 or Phase 3 clinical trial if such termination is by Intrexon due to a material breach by us of the Second Channel Agreement or by us upon 60 days notice after the first 18 months.

 

Our obligation to pay the royalties described above with respect to these “retained” products will survive termination of the Second Channel Agreement.

 

On October 16, 2012, we issued 3,552,210 shares of our Common Stock as consideration in connection with the Second Channel Agreement and the related Stock Issuance Agreement with Intrexon that we entered into on August 6, 2012 (the “Second Stock Issuance Agreement”).

 

We also agreed upon the filing of an Investigational New Drug application with the U.S. Food and Drug Administration for a Synthetic Product, or alternatively the filing of the first equivalent regulatory filing with a foreign regulatory agency (both as applicable, the “IND Milestone Event”), to pay Intrexon either (i) two million dollars ($2M) in cash, or (ii) that number of shares of Common Stock (the “IND Milestone Shares”) having a fair market value equaling two million dollars ($2M) where such fair market value is determined using published market data of the share price for Common Stock at the close of market on the business day immediately preceding the date of public announcement of attainment of the IND Milestone Event.

 

Upon the first to occur of either first commercial sale of a Synthetic Product in a country or the granting of the regulatory approval of that Synthetic Product (both as applicable, the “Approval Milestone Event”), we agreed to pay to Intrexon either (i) three million dollars ($3M) in cash, or (ii) that number of shares of Common Stock (the “Approval Milestone Shares”) having a fair market value equaling three million dollars ($3M) where such fair market value is determined using published market data of the share price for Common Stock at the close of market on the business day immediately preceding the date of public announcement of attainment of the Approval Milestone Event.

 

We also agreed that we will pay an optional and varying fee whereby we remit a payment, in cash or equity at our sole discretion, to Intrexon calculated as a multiple of the number of targets in excess of three (3) total that we desire to elect (the “Field Expansion Fee”). The Field Expansion Fee must be paid completely in either Common Stock or cash, and will comprise either (i) two million dollars ($2M) in cash for each target in excess of three (3) total that we elect, or (ii) that number of shares of Common Stock (the “Field Expansion Fee Shares”) having a fair market value equaling two million dollars ($2M) for each such target that we elect in excess of three where such fair market value is determined using published market data establishing the volume-weighted average price for a share of Common Stock over the thirty (30) day period immediately preceding the date of the Field Expansion Fee Closing.

 

In connection with the transactions contemplated by the Second Stock Issuance Agreement, and pursuant to the First Amendment to Registration Rights Agreement (the “First Amendment to Registration Rights Agreement”) executed and delivered by the parties at the closing, we agreed to file a “resale” registration statement registering the resale of certain of the shares issued under the Second Stock Issuance Agreement. None of the shares to be issued under the Second Stock Issuance Agreement need to be registered until April 30, 2013. Under that agreement, we are obligated to use our reasonable best efforts to cause the “resale” registration statement to be declared effective as promptly as practicable after filing and to maintain the effectiveness of the registration statement until all securities therein are sold or are otherwise can be sold pursuant to Rule 144, without any restrictions.

 

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DNA-Based Therapy Collaboration with Intrexon

 

On November 18, 2011, we entered into a Channel Agreement with Intrexon (the “Channel Agreement”) that governs an “exclusive channel collaboration” arrangement in which we intend to use Intrexon’s technology directed towards the production of prostaglandin synthase (PGIS), through the use of in vivo conditionally regulated embedded controllable bioreactors for the treatment of PAH. The Channel Agreement establishes committees comprised of our and Intrexon representatives that will govern activities related to the PAH program in the areas of project establishment, chemistry, manufacturing and controls, clinical and regulatory matters, commercialization efforts and intellectual property.

 

The Channel Agreement grants us a worldwide license to use specified patents and other intellectual property of Intrexon in connection with the research, development, use, importing, manufacture, sale, and offer for sale of products involving the production of PGIS through the use of an in vivo conditionally regulated embedded controllable bioreactor for the treatment of PAH in humans. Such license is exclusive with respect to any clinical development, selling, offering for sale or other commercialization of Products, and otherwise is non-exclusive. We may not sublicense the rights described without Intrexon’s written consent.

 

Under the Channel Agreement, and subject to certain exceptions, we are responsible for, among other things, the performance of the PAH program including the development, commercialization and certain aspects of manufacturing products. Among other things, Intrexon is responsible for the costs of establishing manufacturing capabilities and facilities for the bulk manufacture of products developed under the PAH program, certain other aspects of manufacturing, costs of discovery-stage research with respect to platform improvements and costs of filing, prosecution and maintenance of Intrexon’s patents.

 

Subject to certain expense allocations and other offsets provided in the Channel Agreement, we will pay Intrexon 50% of the cumulative net quarterly profits derived from the sale of products, calculated on a product-by-product basis. We have likewise agreed to pay Intrexon 50% of quarterly revenue obtained from a sublicensor in the event of a sublicensing arrangement. During the first 18 months, neither we nor Intrexon may terminate the Channel Agreement, except under limited circumstances. Following the first 18 months, we may voluntarily terminate the Channel Agreement upon 90 days written notice to Intrexon. Following the first 18 months, Intrexon may also terminate the Channel Agreement if we elect not to pursue the development of a PAH program identified by Intrexon that is a “Superior Therapy” as defined in the Channel Agreement.

 

Upon termination of the Channel Agreement, we may continue to develop and commercialize any Product that, at the time of termination:

 

•is being commercialized by us,
•has received regulatory approval,

•is a subject of an application for regulatory approval that is pending before the applicable regulatory authority,
•is the subject of at least an ongoing Phase II clinical trial (in the case of a termination by Intrexon due to our uncured breach or a voluntary termination by us), or an ongoing Phase I clinical trial in the Field (as defined in the Channel Agreement) (in the case of a termination by us due to an Intrexon uncured breach or a termination by Intrexon following an unconsented assignment by us or our election not to pursue development of a Superior Therapy), or
•we have spent at least $4.5 million developing.

 

We will be obligated to pay 50% of net profits or revenue with respect to these “retained” products, which will survive termination of the Channel Agreement.

 

As consideration for execution of the Channel Agreement, we entered into a Stock Purchase Agreement with Intrexon (the “Stock Purchase Agreement”) pursuant to which we issued to Intrexon a number of shares of our common stock equal to 9.995% of the number of shares of our common stock issued and outstanding following and giving effect to such issuance (the “First Tranche”) at a purchase price equal to the $0.001 par value of such shares, which issuance was deemed paid in consideration for the execution and delivery of the Channel Agreement. We also agreed to issue additional shares of our common stock to Intrexon upon dosing of the first patient in a Phase II clinical trial sponsored by us in the U.S., or similar study as the parties may agree in a country other than the U.S. The program under this Channel Agreement is in the discovery stage.

 

Under the Stock Purchase Agreement, Intrexon is entitled, at its election, to:

 

(i) participate in our future securities offerings that constitute “Qualified Financings” and purchase securities equal to 19.99% of the number of shares of common stock or other securities sold in such offering. For this purpose, a “Qualified Financing” means a sale of our common stock or equity securities convertible into our common stock in a public or private offering, raising gross proceeds of at least $5 million, where the sale of shares is either registered under the Securities Act of 1933, as amended (the “Securities Act”), at the time of issuance or we agree to register the resale of such shares, and

 

(ii) without restriction, purchase an additional number of shares of our common stock in the open market, or otherwise, that do not exceed an additional 10% of the number of shares of common stock then issued and outstanding.

 

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The Stock Purchase Agreement contains a standstill provision pursuant to which, among other things, Intrexon has agreed that, for a period of three years, subject to certain exceptions and unless invited in writing by us to do so, neither Intrexon nor its affiliates will, directly or indirectly: (i) effect or seek, initiate, offer or propose to effect, or cause or participate in any acquisition of our securities or assets; any tender or exchange offer, merger, consolidation or other business combination involving us; any recapitalization, restructuring, liquidation, dissolution or other extraordinary transaction with respect to us; or any “solicitation” of “proxies” or consents to vote any of our voting securities, or in any way advise or, assist any other person in doing so; (ii) form, join or in any way participate in a “group” with respect to any of our securities; (iii) otherwise act to seek to control or influence the management, Board of Directors or our policies; (iv) take any action reasonably expected to force us to make a public announcement regarding any such matters; or (v) enter into any agreements, discussions or arrangements with any third party with respect to any of the foregoing.

 

In connection with the transactions contemplated by the Stock Purchase Agreement, and pursuant to the Registration Rights Agreement executed and delivered by us to Intrexon, we agreed to file a “resale” registration statement registering the resale of the First Tranche Shares within 120 days of the closing date of such issuance. The registration statement registering such shares was declared effective on April 13, 2012, but is not currently valid due to certain issues regarding the failure of our prior auditor to follow proper partner rotation. Intrexon has agreed not to require us to file a post effective registration statement on Form S-1 with respect to the First Tranche Shares and instead has agreed to wait until we are once again S-3 eligible for registration of such shares.

  

McLean Hospital Exclusive License Agreement and Meda AB Sublicense Agreement

 

In 2005, as amended in 2007 and 2010, we entered into an exclusive license agreement with the McLean Hospital, a Harvard University teaching hospital, relating to U.S. Patent No. 6,610,324 and its foreign equivalents, entitled “Flupirtine in the treatment of fibromyalgia and related conditions.” Pursuant to this agreement, we paid an upfront fee and back patent costs of approximately $62,000 and agreed to pay McLean royalties on net sales of oral flupirtine equal to 3.5% of net sales of oral flupirtine for indications covered by the issued patents, reduced to 1.75% if we have a license to other intellectual property covering those indications. In addition, we agreed to use our best efforts to commercialize oral flupirtine for the therapeutic uses embodied in the patent applications. Furthermore, we agreed to reimburse McLean Hospital all future patent costs and pay the following milestone payments: $150,000 upon the initiation of a pivotal Phase III clinical trial of oral flupirtine; $300,000 upon the filing of an NDA for oral flupirtine; and $600,000 upon FDA approval of oral flupirtine. The due diligence requirements of the exclusive license agreement were amended in April of 2010 and further amended by a Non-Disturbance Agreement that was signed with McLean Hospital, Meda and us. The agreement remains in effect until the later of (i) the date all issued patents and filed patent applications within the Patent Rights (as defined in the agreement) expire or are abandoned and (ii) one year after the last Commercial Sale (as defined in the agreement) for which royalty is due or ten years after expiration or abandonment date set forth in clause (i) above, whichever is earlier. We have the right to terminate the agreement at any time upon 90 days notice. In addition, McLean may terminate the agreement (i) upon 10 days notice for nonpayment unless payment is made within such 10 days, (ii) immediately upon written notice if we fail to maintain required insurance or become insolvent, make an assignment for the benefit of creditors or petition for bankruptcy is filed for or against us or (ii) if we, our affiliates or our sublicensees default in performance of their obligations under the agreement and such default is not cured within 60 days.

 

Effective May 6, 2010, we entered into a Sublicense Agreement with Meda AB of Sweden. Pursuant to this agreement, Meda has been granted an exclusive sublicense to all of our patents covering the use of oral flupirtine for fibromyalgia. These patents have been issued in the U.S. and are pending in Canada and Japan (the “Territory”). This agreement provides that Meda will assume all future development costs for the commercialization of oral flupirtine for fibromyalgia. As consideration for this sublicense, we received an up-front payment of $2.5 million upon execution of this agreement and are entitled to milestone payments of $5 million upon filing of an NDA with the FDA for oral flupirtine for fibromyalgia and $10 million upon marketing approval. This agreement also provides that we are entitled to receive royalties of 7% of net sales of oral flupirtine approved for the treatment of fibromyalgia covered by issued patent claims in the Territory. Pursuant to the terms of this agreement with our university licensor, we are obligated to share half of the royalties we receive with the university licensor, McLean Hospital, and we were obligated to pay them $375,000 upon receipt of an upfront payment, which we did pay in May 2010 when we received the payment from Meda. The agreement continues in effect country by country until the earlier of the expiration of the Royalty Period (as defined in the agreement) or the termination of the McLean license. Meda has the right to terminate the agreement at any time upon 90 days notice. In addition, a party may terminate the agreement upon 30 days notice if the other party breached material obligations and such breach is not cured within a period of time set forth in the agreement. The parties also have the right to terminate the agreement upon 60 days notice in the event of the filing by a party of a bankruptcy petition, the filing of an involuntary petition not dismissed within 60 days, a party proposes a written agreement of composition or extension of its debt, a party becomes Insolvent (as defined in the agreement), liquidates, dissolves, ceases to conduct business or makes an assignment for the benefit of creditors. Upon a termination, all licenses revert to us.

 

The Regents of University of California License Agreement 

 

In July 2005, we were granted an exclusive worldwide license agreement with the Regents of the University of California (the “Regents”) relating to issued U.S. Patent No. 6,936,599 and pending patent applications covering the uses of the drug candidate Trimesta (oral estriol), which has been subsequently amended. Pursuant to this agreement, we paid an upfront license fee and reimbursed patent expenses totaling approximately $61,000 and agreed to pay a license fee of $25,000 during 2006. We also agreed to pay annual maintenance fees, milestone payments totaling $750,000 that are payable on filing an NDA, and on approval of an NDA with the FDA, an additional $750,000 payable upon the first achievement of $50,000,000 in annual sales while covered by a validly issued U.S. patent as well as royalties on net sales of Trimesta covered by the licensed patents. We may be permitted to partially pay milestone payments in the form of equity. The duration of this agreement is from the effective date of July 11, 2005 until the last-to-expire patent in Regent’s Patent Rights, or until the last patent application licensed under this agreement is abandoned and no patent in Regent’s Patent Rights ever issues. We have the right to terminate this agreement at any time and termination will be effective 90 days after the effective date of the termination notice. The Regents may terminate the agreement with a written notice of default if we violate or fail to perform any material term or covenant of this agreement including failure within three years from the successful completion of the ongoing clinical trial of estriol for relapsing-remitting MS being conducted by Dr. Rhonda Voskuhl as principal investigator, to initiate a Phase III clinical trial, or within 17 years of the effective date of the agreement to complete the commercial sale of a product for human therapeutics for the treatment of autoimmune diseases, including MS. However, we have 60 days after the effective date of the notice of default to repair the default.

 

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AEN-100 – Gastroretentive Zinc Acetate

 

AEN-100 is the subject of U.S. and international patent pending applications. On October 26, 2011, we received a final rejection letter with regard to U.S. patent application Ser. No. 11/621,962. On February 15, 2012, we filed a Request for Continued Examination.

 

Manufacturing

 

We utilize contract manufacturing firms to produce our investigational product Trimesta in accordance with “current good manufacturing processes” (cGMP) guidelines outlined by the FDA.

 

Research and Development

 

During the years ended December 31, 2012 and 2011, we incurred $12.3 million and $3.3 million, respectively, in research and development expenses.

 

Competitive Environment

 

The pharmaceutical and biotechnology industries are characterized by rapidly evolving technology and intense competition. Our competitors include major multi-national pharmaceutical companies and biotechnology companies developing both generic and proprietary therapies to treat serious diseases. Many of these companies are well-established and possess technical, human, research and development, financial, and sales and marketing resources significantly greater than ours. In addition, many of our potential competitors have formed strategic collaborations, partnerships and other types of joint ventures with larger, well established industry competitors that afford these companies potential research and development and commercialization advantages in the therapeutic areas we are currently pursuing.

 

Academic research centers, governmental agencies and other public and private research organizations are also conducting and financing research activities which may produce products directly competitive to those being developed by us. In addition, many of these competitors may be able to obtain patent protection, obtain FDA and other regulatory approvals and begin commercial sales of their products before us.

 

Our History

 

Our predecessor, Sheffield Pharmaceuticals, Inc. was incorporated in 1986, and in 2006 engaged in a reverse merger with Pipex Therapeutics, Inc., a Delaware corporation formed in 2001. After the merger, we changed our name to Pipex Pharmaceuticals, Inc., and in October 2008 we changed our name to Adeona Pharmaceuticals, Inc. On October 15, 2009, we reincorporated in the State of Nevada. After reprioritizing our focus on the emerging area of synthetic biologics and entering into our first collaboration with Intrexon, we amended our Articles of Incorporation to change our name to Synthetic Biologics, Inc. on February 15, 2012.

 

Employees

 

As of March 27, 2013, we employed approximately fourteen individuals, eight of whom are full-time employees. A significant number of our management and professional employees have had prior experience with pharmaceutical, biotechnology or medical product companies. None of our employees are covered by collective bargaining agreements, and management considers relations with our employees to be good.

 

Properties

 

Our principal executive offices are located at 155 Gibbs Street, Suite 412, Rockville, Maryland 20850. We also maintain an administrative and finance office in Ann Arbor, Michigan.

 

Available Information

 

Additional information about Synthetic Biologics is contained at our website, www.syntheticbiologics.com. Information on our website is not incorporated by reference into this report. We make available on our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K as soon as reasonably practicable after those reports are filed with the SEC. The following Corporate Governance documents are also posted on our website: Code of Conduct, Code of Ethics for Financial Management and the Charters for the Audit Committee, Compensation Committee and Nominations Committee of the Board of Directors. Our phone number is (734) 332-7800 and our facsimile number is (734) 332-7878.

 

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Item 1A.         Risk Factors

 

Investing in our common stock involves a high degree of risk. In addition to the risks related to our business set forth in this Form 10-K and the other information included and incorporated by reference in this Form 10-K, you should carefully consider the risks described below before purchasing our common stock. Additional risks, uncertainties and other factors not presently known to us or that we currently deem immaterial may also impair our business operations.

 

RISKS RELATING TO OUR BUSINESS

 

We will need to raise additional capital to operate our business.

 

With the exception of the three months ended June 30, 2010, we have experienced significant losses since inception and have a significant accumulated deficit. We expect to incur additional operating losses in the future and therefore our cumulative losses to increase. To date, other than the licensing fee we received from Meda AB for the development and commercialization of Effirma (flupirtine) for fibromyalgia in the U.S., Canada and Japan and limited laboratory revenues from Adeona Clinical Laboratory, which we sold in March 2012, we have generated very minimal revenues. Inasmuch as our sole source of revenue (with the exception of the Meda licensing fee) has been our laboratory revenue and our laboratory was sold recently, we do not expect to derive revenue from any source in the near future until we or our partners successfully commercialize our products. As of December 31, 2012, our accumulated deficit totaled approximately $68.9 million on a consolidated basis. Until such time as we receive approval from the FDA and other regulatory authorities for our product candidates, we will not be permitted to sell our products and therefore will not have product revenues from the sale of products. For the foreseeable future we will have to fund all of our operations and capital expenditures from equity and debt offerings, cash on hand, licensing fees and grants. If our current cash, cash equivalents and short-term investments are not sufficient to sustain our operations, we will need to seek additional sources of financing and such additional financing may not be available on favorable terms, if at all. If we do not succeed in raising additional funds on acceptable terms, we may be unable to complete planned preclinical and clinical trials or obtain approval of our product candidates from the FDA and other regulatory authorities. In addition, we could be forced to delay, discontinue or curtail product development, forego sales and marketing efforts, and forego licensing in attractive business opportunities. Any additional sources of financing will likely involve the issuance of our equity or debt securities, which will have a dilutive effect on our stockholders.

 

We have not been able to sustain profitability.

 

Other than with respect to the three months ended June 30, 2010, we have a history of losses and we have incurred and continue to incur substantial losses and negative operating cash flow. Even if we succeed in developing and commercializing one or more of our product candidates, we may still incur substantial losses for the foreseeable future and may not sustain profitability. We also expect to continue to incur significant operating and capital expenditures and anticipate that our expenses will substantially increase in the foreseeable future as we do the following:

 

●continue to undertake preclinical development and clinical trials for our product candidates;
●expand our research activities with Intrexon relating to monoclonal antibodies for infectious diseases;
●seek regulatory approvals for our product candidates;
●develop our product candidates for commercialization;
●implement additional internal systems and infrastructure;
●lease additional or alternative office facilities; and
●hire additional personnel, including members of our management team.

 

We may experience negative cash flow for the foreseeable future as we fund our technology development with capital expenditures. As a result, we will need to generate significant revenues in order to achieve and maintain profitability. We may not be able to generate these revenues or achieve profitability in the future. Our failure to achieve or maintain profitability could negatively impact the value of our common stock and underlying securities.

 

Our research and development efforts may not succeed in developing commercially successful products and technologies, which may limit our ability to achieve profitability.

 

We must continue to explore opportunities that may lead to new products and technologies. To accomplish this, we must commit substantial efforts, funds, and other resources to research and development. A high rate of failure is inherent in the research and development of new products and technologies. Any such expenditures that we make will be made without any assurance that our efforts will be successful. Failure can occur at any point in the process, including after significant funds have been invested.

 

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Regardless of whether our clinical trials are deemed to be successful, promising new product candidates may fail to reach the market or may only have limited commercial success because of efficacy or safety concerns, failure to achieve positive clinical outcomes, inability to obtain necessary regulatory approvals or satisfy regulatory criteria, limited scope of approved uses, excessive costs to manufacture, the failure to establish or maintain intellectual property rights, or infringement of the intellectual property rights of others. Even if we successfully develop new products or enhancements, they may be quickly rendered obsolete by changing customer preferences, changing industry standards, or competitors' innovations. Innovations may not be quickly accepted in the marketplace because of, among other things, entrenched patterns of clinical practice or uncertainty over third-party reimbursement. We cannot state with certainty when or whether any of our products under development will be launched, whether we will be able to develop, license, or otherwise acquire drug candidates or products, or whether any products will be commercially successful. Failure to launch successful new products or new indications for existing products may cause our products to become obsolete, which may limit our ability to achieve profitability.

 

The technology on which our channel partnering arrangements with Intrexon is based on early stage technology.

 

We have an exclusive channel collaboration arrangement with Intrexon that contemplates the use of Intrexon’s transgene engineering platform technology and regulatory control technology for the in vivo cellular production of PGIS, a specific effector enzyme that regulates the production of prostacyclin. Such technologies have a limited history of use in the design and development of human therapeutic product candidates and may therefore involve unanticipated risks or delays.

 

On August 8, 2012, we announced an additional exclusive channel collaboration with Intrexon relating to the design, production, testing and commercialization of monoclonal antibodies for the treatment of certain infectious diseases. Although monoclonal antibody therapeutics are well established in the biotechnology and pharmaceutical sectors, their use for the treatment of infectious disease is extremely limited. In order for monoclonal antibodies to be effective for infectious diseases, they must not only properly target the organism of interest (or its toxins), but may also need to overcome defenses and forms of resistance of such organisms. To accomplish this may require the use of more than one specific monoclonal antibody, and mixtures of different monoclonal antibodies, which may create additional unforeseen complications, including increased manufacturing complexity and expense. In order to be competitive, monoclonal antibodies will be required to be produced at a low enough cost of goods in order to be profitably marketed. We have very limited development and manufacturing experience in the field of monoclonal antibodies and infectious disease. We cannot assure that any monoclonal antibody candidates will provide satisfactory in vitro and in vivo nonclinical results sufficient to warrant the expense of cGMP manufacture and clinical testing in human clinical trials.

 

DNA-based therapy has not yet been proven to be successful.

 

The FDA has not yet approved any human DNA-based therapy product for sale. The field of DNA-based therapy, also referred to as gene therapy or gene transfer, is experimental and has not yet proven successful in many clinical trials. Clinical trials with DNA-based therapy have encountered a multitude of significant technical problems in the past, including, unintended integration with host DNA, poor levels of protein expression, transient protein expression, viral overload, immune reactions to either viral capsids utilized to deliver DNA, DNA itself, proteins expressed or cells transfected with DNA. There can be no assurance that our preclinical animals studies or human clinical trials will be successful or that we will receive the regulatory approvals necessary to initiate such studies. To the extent that we utilize viral constructs or other systems to deliver our DNA-based therapies and the same or similar delivery systems demonstrate unanticipated and/or unacceptable side effects in preclinical or clinical trials conducted by ourselves or others we may be forced to, or elect to, discontinue development of such product candidates. We do not intend to pursue further development of our previously announced program for pulmonary arterial hypertension. However, we are currently in discussions with Intrexon to substitute this program with an alternate program better suited to our current objectives and focus.

 

We may not generate additional revenue from our relationships with our corporate collaborators.

 

On May 6, 2010, we entered into a sublicense agreement with Meda AB whereby we may receive milestone payments totaling $17.5 million (including an upfront payment of $2.5 million that has already been received), plus royalties on our flupirtine program. There can be no assurance that Meda AB will successfully develop flupirtine for fibromyalgia in the U.S., Canada or Japan that would allow us to receive such additional $15 million in milestone payments and royalties on sales in connection with such agreement. The successful achievement of the various milestones set forth in the sublicense agreement is not within our control and we will be dependent upon Meda AB for achievement of such milestones. According to Meda’s 2012 Year-End Report filed in February 2013, Meda has received the go-ahead from the FDA to conduct a Phase II proof of concept study for the treatment of fibromyalgia. There can be no assurance that Meda will initiate or successfully complete such planned study.

 

We have experienced several management changes.

 

We have had significant changes in management in the past few years. Jeffrey Riley was appointed Chief Executive Officer and President on February 3, 2012. Effective February 6, 2012, C. Evan Ballantyne was appointed Chief Financial Officer. James S. Kuo, M.D., served as Chief Executive Officer and President from February 6, 2010 until February 3, 2012. Changes in our key positions, as well as additions of new personnel and departures of existing personnel, can be disruptive, might lead to additional departures of existing personnel and could have a material adverse effect on our business, operating results, financial results and internal controls over financial reporting.

 

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We may not be able to retain rights licensed to us by others to commercialize key products and may not be able to establish or maintain the relationships we need to develop, manufacture, and market our products.

 

In addition to our own patent applications, we also currently rely on licensing agreements with third party patent holders/licensors for our products. We have an exclusive license agreement with the McLean Hospital relating to the use of flupirtine to treat fibromyalgia which was sublicensed to Meda AB and an exclusive license agreement with the Regents of the University of California relating to our Trimesta technology. Each of these agreements requires us or our sublicensee to use our best efforts to commercialize each of the technologies as well as meet certain diligence requirements and timelines in order to keep the license agreement in effect. In the event we or our sublicensee are not able to meet our diligence requirements, we may not be able to retain the rights granted under our agreements or renegotiate our arrangement with these institutions on reasonable terms, or at all. Furthermore, we currently have very limited product development capabilities, and limited marketing or sales capabilities. For us to research, develop, and test our product candidates, we would need to contract with outside researchers, in most cases those parties that did the original research and from whom we have licensed the technologies. Our exclusive channel collaboration agreements with Intrexon provide that Intrexon may terminate each such agreement if we do not perform certain specified requirements, including developing therapies considered superior. Our agreement with The University of Texas allows the Universtiy to terminate its agreement if we fail to comply with the terms of the agreement. Our agreement with Prev provides Prev with the right to the return of the assets if we do not perform certain requirements.

 

We can give no assurances that any of our issued patents licensed to us or any of our other patent applications will provide us with significant proprietary protection or be of commercial benefit to us. Furthermore, the issuance of a patent is not conclusive as to its validity or enforceability, nor does the issuance of a patent provide the patent holder with freedom to operate without infringing the patent rights of others.

 

We will incur additional expenses in connection with our exclusive channel collaboration arrangements with Intrexon and Prev.

 

Pursuant to our exclusive channel collaborations with Intrexon, we are responsible for future research and development expenses of product candidates developed under each such collaboration, the effect of which has and will continue to increase the level of our overall research and development expenses going forward. Our agreement with Prev requires that we initiate certain studies and file an NDA within a certain amount of time, each of which are costly and will require additional expenditures. Although all manufacturing, preclinical studies and human clinical trials are expensive and difficult to design and implement, costs associated with the manufacturing, research and development of biologic product candidates are generally greater in comparison to small molecule product candidates. We have added additional personnel and expect to add additional personnel to support our exclusive channel collaborations with Intrexon, and research and development of our biologic candidate, SYN-004.

 

Because our biologic programs are relatively new, we have only recently assumed development responsibility and costs associated with such programs. In addition, because development activities in collaboration with Intrexon are determined pursuant to a joint steering committees comprised of Intrexon and ourselves and we have limited experience, future development costs associated this program may be difficult to anticipate and exceed our expectations. Our actual cash requirements may vary materially from our current expectations for a number of other factors that may include, but are not limited to, unanticipated technical challenges, changes in the focus and direction of our development activities or adjustments necessitated by changes in the competitive landscape in which we operate. If we are unable to continue to financially support such collaborations due to our own working capital constraints, we may be forced to delay our activities. If we are unable to obtain additional financing on terms acceptable to us or at all, we may be forced to seek licensing partners or discontinue development.

 

Developments by competitors may render our products or technologies obsolete or non-competitive.

 

Companies that currently sell or are developing both generic and proprietary products to treat multiple sclerosis include: Abbott Biotherapeutics Corporation, Bayer Health Care, Biogen Idec, Genzyme, GlaxoSmithKline Pharmaceuticals, Merck & Co., Pfizer, Novartis, Sanofi and Teva Pharmaceuticals. Companies that currently sell or are developing both generic and proprietary products to treat infectious diseases include: MedImmune, Pfizer, Cubist, Optimer Pharmaceuticals, Symphogen, Merus, GlaxoSmithKline Pharmaceuticals and Merck & Co.. Many of our competitors have significant financial and human resources. The infectious disease market is highly competitive with many generic and proprietary intravenous and oral formulations available to physicians and their patients. For our monoclonal antibodies, we currently do not expect to be able to deliver our infectious disease candidates via the oral route and may thus be limited to the in-patient and/or acute treatment setting. In addition, academic research centers may develop technologies that compete with our Trimesta and flupirtine technologies. Should clinicians or regulatory authorities view these therapeutic regiments as more effective than our products, this might delay or prevent us from obtaining regulatory approval for our products, or it might prevent us from obtaining favorable reimbursement rates from payers, such as Medicare, Medicaid, hospitals and private insurers.

 

We operate in a highly competitive environment.

 

The pharmaceutical and biotechnology industries, including the monoclonal antibody industry, are characterized by rapidly evolving technology and intense competition. Our competitors include major multi-national pharmaceutical companies and biotechnology companies developing both generic and proprietary therapies to treat serious diseases. Many of these companies are well-established and possess technical, human, research and development, financial, and sales and marketing resources significantly greater than ours. In addition, many of our potential competitors have formed strategic collaborations, partnerships and other types of joint ventures with larger, well established industry competitors that afford these companies potential research and development and commercialization advantages in the therapeutic areas we are currently pursuing.

 

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Academic research centers, governmental agencies and other public and private research organizations are also conducting and financing research activities which may produce products directly competitive to those being developed by us. In addition, many of these competitors may be able to obtain patent protection, obtain FDA and other regulatory approvals and begin commercial sales of their products before us.

 

Competitors could develop and/or gain FDA approval of our product candidates for a different indication.

 

Since we do not have composition of matter patent claims for flupirtine and estriol, others may obtain approvals for other uses of these products that are not covered by our issued or pending patents. For example, the active ingredients in both Effirma (flurpirtine) and Trimesta (oral estriol) have been approved for marketing in overseas countries for different uses. Other companies, including the original developers or licensees or affiliates may seek to develop Effirma or Trimesta or their respective active ingredient(s) for other uses in the U.S. or any country we are seeking approval for. We cannot provide any assurances that any other company may obtain FDA approval for products that contain flupirtine and estriol in various formulations or delivery systems that might adversely affect our ability or the ability of Meda to develop and market these products in the U.S. We are aware that other companies have intellectual property protection using the active ingredients and have conducted clinical trials of flupirtine and estriol for different applications than what we are developing. Many of these companies may have more resources than us. We cannot provide any assurances that our products will be FDA-approved prior to our competitors.

 

If a product containing our active ingredients is already marketed or if the FDA approves other products containing our active ingredients in the future to treat indications, physicians may elect to prescribe and substitute a competitor’s products to treat the diseases for which we are intending to commercialize; this is commonly referred to as “off-label” use. While under FDA regulations a competitor is not allowed to promote off-label uses of its product, the FDA does not regulate the practice of medicine and, as a result, cannot direct physicians to select certain products for their patients. Consequently, we might be limited in our ability to prevent off-label use of a competitor’s product to treat the diseases we are intending to commercialize, even if we have issued method of use patents for that indication. If we are not able to obtain and enforce our patents, if any, or otherwise receive orphan drug protection in the case of ALS, a competitor could develop and commercialize similar products for the same indications that we are pursuing. We cannot provide any assurances that a competitor will not obtain FDA approval for a product that contains the same active ingredients as our products.

 

We rely on method patents and patent applications and various regulatory exclusivities to protect some of our product candidates and our ability to compete may be limited or eliminated if we are not able to protect our products.

 

Our competitiveness may be adversely affected if we are unable to protect our proprietary technologies. We do not have composition of matter patents for Trimesta or Effirma, or their respective active ingredients estriol and flupirtine. We rely on issued patent and pending patent applications for use of Trimesta to treat MS (issued U.S. Patent Nos. 6,936,599 and 8,372,826) and various other therapeutic indications, which have been exclusively licensed to us. We have exclusively licensed an issued patent for the treatment of fibromyalgia with flupirtine, which we have sublicensed to Meda AB.

 

Our AEN-100 drug candidate (gastroretentive zinc acetate) is the subject of U.S. and international pending patent applications, such as published U.S. patent application Ser. No. 11/621,962 and corresponding international applications that claim priority to January 10, 2006 as well as additional patent applications. On October 26, 2011, we received a final rejection letter with regard to U.S. patent application Ser. No. 11/621,962. On February 15, 2012, we filed a Request for Continued Examination. Our inability to obtain patent protection could hinder our partnering efforts.

 

The patent positions of pharmaceutical companies are uncertain and may involve complex legal and factual questions. We may incur significant expense in protecting our intellectual property and defending or assessing claims with respect to intellectual property owned by others. Any patent or other infringement litigation by or against us could cause us to incur significant expense and divert the attention of our management.

 

Others may file patent applications or obtain patents on similar technologies or compounds that compete with our products. We cannot predict how broad the claims in any such patents or applications will be, and whether they will be allowed. Once claims have been issued, we cannot predict how they will be construed or enforced. We may infringe intellectual property rights of others without being aware of it. If another party claims we are infringing their technology, we could have to defend an expensive and time consuming lawsuit, pay a large sum if we are found to be infringing, or be prohibited from selling or licensing our products unless we obtain a license or redesign our product, which may not be possible.

 

We also rely on trade secrets and proprietary know-how to develop and maintain our competitive position. Some of our current or former employees, consultants, scientific advisors, current or prospective corporate collaborators, may unintentionally or willfully disclose our confidential information to competitors or use our proprietary technology for their own benefit. Furthermore, enforcing a claim alleging the infringement of our trade secrets would be expensive and difficult to prove, making the outcome uncertain. Our competitors may also independently develop similar knowledge, methods, and know-how or gain access to our proprietary information through some other means.

 

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We may fail to retain or recruit necessary personnel, and we may be unable to secure the services of consultants.

 

As of March 27, 2013, we employed approximately fourteen individuals, eight of whom are full-time employees. We have also engaged clinical consultants to advise us on our clinical programs and regulatory consultants to advise us on our dealings with the FDA and other foreign regulatory authorities. We have been and will be required to retain additional consultants and employees in order to fulfill our obligations under our exclusive channel collaborations with Intrexon and our development obligations under our agreement with Prev. Our future performance will depend in part on our ability to successfully integrate newly hired officers into our management team and our ability to develop an effective working relationship among senior management.

 

Certain of our directors, scientific advisors, and consultants serve as officers, directors, scientific advisors, or consultants of other biopharmaceutical or biotechnology companies that might be developing competitive products to ours. Other than corporate opportunities, none of our directors are obligated under any agreement or understanding with us to make any additional products or technologies available to us. Similarly, we can give no assurances, and we do not expect and stockholders should not expect, that any biomedical or pharmaceutical product or technology identified by any of our directors or affiliates in the future would be made available to us other than corporate opportunities. We can give no assurances that any such other companies will not have interests that are in conflict with our interests.

 

Losing key personnel or failing to recruit necessary additional personnel would impede our ability to attain our development objectives. There is intense competition for qualified personnel in the drug and biologic development areas, and we may not be able to attract and retain the qualified personnel we would need to develop our business.

 

We rely on independent organizations, advisors, and consultants to perform certain services for us, including handling substantially all aspects of regulatory approval, clinical management, manufacturing, marketing, and sales. We expect that this will continue to be the case. Such services may not always be available to us on a timely basis when we need them.

 

If the parties we depend on for supplying substance raw materials for our product candidates and certain manufacturing-related services do not timely supply these products and services in sufficient quality or quantity, it may delay or impair our ability to develop, manufacture and market our product candidates.

 

We rely on suppliers for the substance raw materials of our product candidates and third parties for certain manufacturing-related services to produce material that meets appropriate content, quality and stability standards and use in clinical trials of our products and, after approval, for commercial distribution. We have not yet established cGMP manufacturers for our biologic and drug candidates. To succeed, clinical trials require adequate supplies of study material, which may be difficult or uneconomical to procure or manufacture. We and our suppliers and vendors may not be able to (i) produce our study material to appropriate standards for use in clinical studies, (ii) perform under any definitive manufacturing, supply or service agreements with us, or (iii) remain in business for a sufficient time to successfully produce and market our product candidates. If we do not maintain important manufacturing and service relationships, we may fail to find a replacement supplier or required vendor or develop our own manufacturing capabilities which could delay or impair our ability to obtain regulatory approval for our products and substantially increase our costs or deplete profit margins, if any. If we do find replacement manufacturers and vendors, we may not be able to enter into agreements with them on terms and conditions favorable to us and, there could be a substantial delay before a new facility could be qualified and registered with the FDA and foreign regulatory authorities.

 

If successful large-scale manufacturing of DNA-based products is not possible, we or our collaborators may be unable to manufacture enough of our product candidates to achieve regulatory approval or market our DNA-based products.

 

Few companies to date have demonstrated successful large-scale manufacturing of DNA-based products, including those that have had significantly more resources than us and it is anticipated that significant challenges will be faced in the scale-up of our manufacturing process for commercial production. There are a limited number of contract manufacturers qualified to perform large-scale manufacturing of DNA-based products. We or our collaborators may be unable to manufacture commercial-scale quantities of DNA-based products or receive appropriate government approvals on a timely basis or at all. Failure to successfully manufacture or obtain appropriate government approvals on a timely basis or at all would prevent us from achieving our business objectives.

 

Clinical trials are very expensive, time-consuming, and difficult to design and implement.

 

Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time-consuming. We estimate that clinical trials of our product candidates would take at least several years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials. Commencement and completion of clinical trials may be delayed by several factors, including:

 

●obtaining an IND application with the FDA to commence clinical trials;
●identification of, and acceptable arrangements with, one or more clinical sites;
●obtaining IRB approval to commence clinical trials;
●unforeseen safety issues;
●determination of dosing;
●lack of effectiveness during clinical trials;
●slower than expected rates of patient recruitment;
●inability to monitor patients adequately during or after treatment;
●inability or unwillingness of medical investigators to follow our clinical protocols; and

 

 

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●unwillingness of the FDA or IRBs to permit the clinical trials to be initiated.

 

In addition, we, IRBs or the FDA may suspend our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if IRBs or the FDA finds deficiencies in our submissions or conduct of our trials.

 

The results of our clinical trials may not support our product candidate claims and the results of preclinical studies and completed clinical trials are not necessarily predictive of future results.

 

To date, long-term safety and efficacy have not yet been demonstrated in clinical trials for any of our product candidates. Favorable results in our early studies or trials may not be repeated in later studies or trials. Even if our clinical trials are initiated and completed as planned, we cannot be certain that the results will support our product candidate claims. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful. Furthermore, success of our predecessor with P1A, does not ensure success of SYN-004. We cannot be sure that the results of later clinical trials would replicate the results of prior clinical trials and preclinical testing nor that they would satisfy the requirements of the FDA or other regulatory agencies. Clinical trials may fail to demonstrate that our product candidates are safe for humans and effective for indicated uses. Any such failure could cause us or our sublicensee to abandon a product candidate and might delay development of other product candidates. Preclinical and clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals or commercialization. Any delay in, or termination of, our clinical trials would delay our obtaining FDA approval for the affected product candidate and, ultimately, our ability to commercialize that product candidate.

 

We depend on third parties, including researchers and sublicensees, who are not under our control.

 

Since we have in-licensed some of our product candidates, have sublicensed a product candidate and have collaboration agreements for the development of other product candidates, we depend upon our sublicensee and independent investigators and scientific collaborators, such as universities and medical institutions or private physician scientists, to advise us and to conduct our preclinical and clinical trials under agreements with us. These collaborators are not our employees and we cannot control the amount or timing of resources that they devote to our programs or the timing of their procurement of clinical-trial data or their compliance with applicable regulatory guidelines. Should any of these scientific inventors/advisors or those of our sublicensee become disabled or die unexpectedly, or should they fail to comply with applicable regulatory guidelines, we or our sublicensee may be forced to scale back or terminate development of that program. They may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking those programs ourselves. Failing to devote sufficient time and resources to our drug-development programs, or substandard performance and failure to comply with regulatory guidelines, could result in delay of any FDA applications and our commercialization of the drug candidate involved.

 

These collaborators may also have relationships with other commercial entities, some of which may compete with us. Our collaborators assisting our competitors could harm our competitive position. For example, we are highly dependent on scientific collaborators for our Trimesta development program. Specifically, all of the clinical trials have been conducted under investigator-sponsored IND applications, not corporate-sponsored INDs. We have sometimes experienced difficulty in collecting data generated from these investigator-sponsored clinical trials for our programs. We cannot provide any assurances that we will not experience any additional delays in the future.

 

We are also highly dependent on government and private grants to fund certain of our clinical trials for our product candidates. For example, Trimesta (oral estriol) has received grants totaling over $8 million, predominantly from the Southern California Chapter of the NMSS and the National Institutes of Health which funds a majority of the ongoing clinical trial in relapsing-remitting MS for women. Although we believe that the grant funding received to date is sufficient to complete the current clinical trial based upon current cost estimates, if we experience any additional unanticipated costs or require further clinical trials, and our scientific collaborator is unable to maintain or receive additional grants, we might be forced to scale back or terminate the development of this product candidate. We will also need to cross reference our IND with the inventor/IND holder for this program should we elect to file our own corporate IND for our Trimesta (oral estriol) program. The on-going and future development and commercialization of Effirma (flupirtine) for fibromyalgia is the responsibility of Meda AB and no assurance can be given that Meda will gain the FDA’s acceptance of the NDA or obtain NDA approval from the FDA of flupirtine for fibromyalgia.

 

With respect to our product candidates in collaboration with Intrexon, we are dependent upon Intrexon’s synthetic biology facilities and capabilities as we have no such facilities and capabilities of our own. We are also reliant on their vector engineering platform, gene expression switch technology, monoclonal antibody discovery, production cell line development and know-how. If any of the foregoing were to become inaccessible or terminated, it would be difficult for us to develop and commercialize our synthetic biologic product candidates.

 

We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, as well as costs associated with lawsuits.

 

If any other person files patent applications, or is issued patents, claiming technology also claimed by us in pending applications, we may be required to participate in interference proceedings in the U.S. Patent and Trademark Office to determine priority of invention. We, or our licensors, may also need to participate in interference proceedings involving our issued patents and pending applications of another entity.

 

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The intellectual property environment in the area of DNA-based therapeutics is particularly complex, constantly evolving and highly fragmented. Other companies and institutions have issued patents and have filed or will file patent applications that may issue into patents that cover or attempt to cover genes, vectors, cell lines, and methods of making and using DNA and DNA-based therapy products used in, or similar to our product candidate, and technologies. The same is true of the monoclonal antibody field in terms of methods of producing monoclonal antibodies for human use. We have not conducted freedom-to-use patent searches on all aspects of our product candidates or potential product candidates, and we may be unaware of relevant patents and patent applications of third parties. In addition, the freedom-to-use patent searches that have been conducted may not have identified all relevant issued patents or pending patents. We cannot provide assurance that our proposed products in this area will not ultimately be held to infringe one or more valid claims owned by third parties which may exist or come to exist in the future or that in such case we will be able to obtain a license from such parties on acceptable terms.

 

We cannot guarantee that the practice of our technologies will not conflict with the rights of others. In some foreign jurisdictions, we could become involved in opposition proceedings, either by opposing the validity of another’s foreign patent or by persons opposing the validity of our foreign patents.

 

We may also face frivolous litigation or lawsuits from various competitors or from litigious securities attorneys. The cost to us of any litigation or other proceeding relating to these areas, even if deemed frivolous or resolved in our favor, could be substantial and could distract management from our business. Uncertainties resulting from initiation and continuation of any litigation could have a material adverse effect on our ability to continue our operations.

 

If we infringe the rights of others we could be prevented from selling products or forced to pay damages.

 

If our products, methods, processes, and other technologies are found to infringe the proprietary rights of other parties, we could be required to pay damages, or we may be required to cease using the technology or to license rights from the prevailing party. Any prevailing party may be unwilling to offer us a license on commercially acceptable terms.

 

RISKS RELATING TO OUR STOCK

 

We will seek to raise additional funds in the future, which may be dilutive to stockholders or impose operational restrictions.

 

We expect to seek to raise additional capital in the future to help fund development of our proposed products. If we raise additional capital through the issuance of equity or of debt securities, the percentage ownership of our current stockholders will be reduced. We may also enter into strategic transactions, issue equity as part of license issue fees to our licensors, compensate consultants or settle outstanding payables using equity that may be dilutive. Our stockholders may experience additional dilution in net book value per share and any additional equity securities may have rights, preferences and privileges senior to those of the holders of our common stock.

 

We are substantially controlled by our current officers, directors, and principal stockholders.

 

Currently, our directors, executive officers, and principal stockholders beneficially own a substantial number of shares of our common stock. As a result, they will be able to exert substantial influence over the election of our Board of Directors and the vote on issues submitted to our stockholders. Our executive officers and directors beneficially owned approximately 8.9 million shares of our common stock, including stock options and warrants exercisable within 60 days of March 27, 2013. Randal J. Kirk indirectly beneficially owns approximately 9.8 million shares of our common stock. Our executive officers, directors and principal stockholders together beneficially owned approximately 18.7 million shares of our common stock, including the stock options and warrants exercisable within 60 days of March 27, 2013. Because our common stock has from time to time been “thinly traded”, the sale of a substantial number of shares by our executive officers, directors and principal stockholders would have an adverse effect on the market for our stock and our share price.

 

Our shares of common stock are from time to time thinly traded, so stockholders may be unable to sell at or near ask prices or at all if they need to sell shares to raise money or otherwise desire to liquidate their shares.

 

Our common stock has from time to time been “thinly-traded,” meaning that the number of persons interested in purchasing our common stock at or near ask prices at any given time may be relatively small or non-existent. This situation is attributable to a number of factors, including the fact that we are a small company that is relatively unknown to stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable. As a consequence, there may be periods of several days or more when trading activity in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price. We cannot give stockholders any assurance that a broader or more active public trading market for our common shares will develop or be sustained, or that current trading levels will be sustained.

 

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We cannot assure you that the common stock will be liquid or that it will remain listed on the NYSE MKT.

 

We cannot assure you that we will be able to maintain the continued listing standards of the NYSE MKT (formerly the NYSE Amex and the American Stock Exchange). The NYSE MKT requires companies to meet certain continued listing criteria including certain minimum stockholders' equity and equity prices per share as outlined in the NYSE MKT Exchange Company Guide. We may not be able to maintain such minimum stockholders' equity or prices per share or may be required to effect a reverse stock split to maintain such minimum prices and/or issue additional equity securities in exchange for cash or other assets, if available, to maintain certain minimum stockholders' equity required by the NYSE MKT. If we are delisted from the NYSE MKT then our common stock will trade, if at all, only on the over-the-counter market, such as the OTC Bulletin Board securities market, and then only if one or more registered broker-dealer market makers comply with quotation requirements. In addition, delisting of our common stock could depress our stock price, substantially limit liquidity of our common stock and materially adversely affect our ability to raise capital on terms acceptable to us, or at all. Delisting from the NYSE MKT could also have other negative results, including the potential loss of confidence by suppliers and employees, the loss of institutional investor interest and fewer business development opportunities. In order to remain listed on NYSE MKT, we are required to maintain a minimum stockholders’ equity of $6 million.

 

There may be issuances of shares of preferred stock in the future.

 

Although we currently do not have preferred shares outstanding, the Board of Directors could authorize the issuance of a series of preferred stock that would grant holders preferred rights to our assets upon liquidation, the right to receive dividends before dividends would be declared to common stockholders, and the right to the redemption of such shares, possibly together with a premium, prior to the redemption of the common stock. To the extent that we do issue preferred stock, the rights of holders of common stock could be impaired thereby, including without limitation, with respect to liquidation.

 

Our failure to fulfill all of our registration requirements may cause us to suffer liquidated damages, which may be very costly.

 

Pursuant to the terms of the registration rights agreement that we entered into with Intrexon and an affiliated entity, we are required to file a registration statement with respect to securities issued to them within a certain time period and maintain the effectiveness of such registration statement. The failure to do so could result in the payment of damages by us. There can be no assurance as to when the registration statement will be declared effective or that we will be able to maintain the effectiveness of any registration statement, and therefore there can be no assurance that we will not incur damages with respect to such agreements.

 

RISKS RELATED TO OUR INDUSTRY

 

We are subject to government regulation, compliance with which can be costly and difficult.

 

In the U.S., the formulation, manufacturing, packaging, storing, labeling, promotion, advertising, distribution and sale of our products are subject to regulation by various governmental agencies, including (1) the FDA, (2) the Federal Trade Commission, or FTC, (3) the Consumer Product Safety Commission, or CPSC, (4) the U.S. Department of Agriculture, or USDA. Our proposed activities may also be regulated by various agencies of the states, localities and foreign countries in which our proposed products may be manufactured, distributed and sold. The FDA, in particular, regulates the formulation, manufacture and labeling of over-the-counter, or OTC drugs, prescription drugs, conventional foods, dietary supplements, and cosmetics such as those that we intend to distribute. FDA regulations require us and our suppliers to meet relevant cGMP regulations for the preparation, packing, labeling, and storage of all drugs and foods.

 

Any products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing FDA regulation, including record-keeping requirements, reporting of adverse experiences, submitting periodic reports, drug sampling and distribution requirements, manufacturing or labeling changes, record-keeping requirements, and compliance with FDA promotion and advertising requirements. Drug manufacturers and their subcontractors are required to register their facilities with the FDA and state agencies, and are subject to periodic unannounced inspections for GMP compliance, imposing procedural and documentation requirements upon us and third-party manufacturers. Failure to comply with these regulations could result, among other things, in suspension of regulatory approval, recalls, suspension of production or injunctions, seizures, or civil or criminal sanctions. We cannot be certain that we or our present or future subcontractors will be able to comply with these regulations.

 

The FDA regulates prescription drug labeling and promotion activities. The FDA actively enforces regulations prohibiting the marketing of products for unapproved uses. The FDA permits the promotion of drugs for unapproved uses in certain circumstances, subject to stringent requirements. We and our product candidates are subject to a variety of state laws and regulations which may hinder our ability to market our products. Whether or not FDA approval has been obtained, approval by foreign regulatory authorities must be obtained prior to commencing clinical trials, and sales and marketing efforts in those countries. These approval procedures vary in complexity from country to country, and the processes may be longer or shorter than that required for FDA approval. We may incur significant costs to comply with these laws and regulations now or in the future.

 

The FDA, comparable foreign regulators and state and local pharmacy regulators impose substantial requirements upon clinical development, manufacture and marketing of pharmaceutical products. These and other entities regulate research and development and the testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising, and promotion of our products. The drug approval process required by the FDA under the Food, Drug, and Cosmetic Act generally involves:

  

●preclinical laboratory and animal tests;
●submission of an IND, prior to commencing human clinical trials;
●adequate and well-controlled human clinical trials to establish safety and efficacy for intended use;

 

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●submission to the FDA of an NDA or Biologics License Application (BLA); and
●FDA review and approval of an NDA or BLA.

 

The testing and approval process requires substantial time, effort, and financial resources, and we cannot be certain that any approval will be granted on a timely basis, if at all.

 

Preclinical tests include laboratory evaluation of the product candidate, its chemistry, formulation and stability, and animal studies to assess potential safety and efficacy. Certain preclinical tests must be conducted in compliance with good laboratory practice regulations. Violations of these regulations can, in some cases, lead to invalidation of the studies, requiring them to be replicated. In some cases, long-term preclinical studies are conducted concurrently with clinical studies.

 

We will submit the preclinical test results, together with manufacturing information and analytical data, to the FDA as part of an IND, which must become effective before we begin human clinical trials. The IND automatically becomes effective 30 days after filing, unless the FDA raises questions about conduct of the trials outlined in the IND and imposes a clinical hold, in which case, the IND sponsor and FDA must resolve the matters before clinical trials can begin. It is possible that our submission may not result in FDA authorization to commence clinical trials.

 

Clinical trials must be supervised by qualified investigators in accordance with good clinical practice (GCP) regulations, which include informed consent requirements. Each study must be approved and monitored by the appropriate IRBs which are periodically informed of the study’s progress, adverse events and changes in research. Annual updates are submitted to the FDA and more frequently if certain serious adverse events occur.

 

Human clinical trials of drug candidates typically have three sequential phases that may overlap:

 

Phase I: The drug is initially tested in healthy human subjects or patients for safety, dosage tolerance, absorption, metabolism, distribution, and excretion.

 

Phase II: The drug is studied in a limited patient population to identify possible adverse effects and safety risks, determine efficacy for specific diseases and establish dosage tolerance and optimal dosage.

 

Phase III: When Phase II evaluations demonstrate that a dosage range is effective with an acceptable safety profile, Phase III trials to further evaluate dosage, clinical efficacy and safety, are undertaken in an expanded patient population, often at geographically dispersed sites.

 

We cannot be certain that we will successfully complete Phase I, Phase II, or Phase III testing of our product candidates within any specific time period, if at all. Furthermore, the FDA, an IRB or the IND sponsor may suspend clinical trials at any time on various grounds, including a finding that subjects or patients are exposed to unacceptable health risk. Concurrent with these trials and studies, we also develop chemistry and physical characteristics data and finalize a manufacturing process in accordance with good manufacturing practice (GMP) requirements. The manufacturing process must conform to consistency and quality standards, and we must develop methods for testing the quality, purity, and potency of the final products. Appropriate packaging is selected and tested, and chemistry stability studies are conducted to demonstrate that the product does not undergo unacceptable deterioration over its shelf-life. Results of the foregoing are submitted to the FDA as part of a NDA (or BLA in case of biologic products) for marketing and commercial shipment approval. The FDA reviews each NDA or BLA submitted and may request additional information.

 

Once the FDA accepts the NDA or BLA for filing, it begins its in-depth review. The FDA has substantial discretion in the approval process and may disagree with our interpretation of the data submitted or identify new concerns. The process may be significantly extended by requests for new information or clarification of information already submitted. As part of this review, the FDA may refer the application to an advisory committee, typically a panel of clinicians. Manufacturing establishments often are inspected prior to NDA or BLA approval to assure compliance with GMPs and with manufacturing commitments made in the application.

 

Submission of an NDA or BLA with clinical data requires payment of a fee. In return, the FDA assigns a goal of ten months for issuing its “complete response,” in which the FDA may approve or deny the NDA or BLA, or require additional clinical data. Even if these data are submitted, the FDA may ultimately decide the NDA or BLA does not satisfy approval criteria. If the FDA approves the NDA or BLA, the product becomes available for marketing. Product approval may be withdrawn if regulatory compliance is not maintained or safety problems occur. The FDA may require post-marketing studies, also known as phase IV studies, as a condition of approval, and requires surveillance programs to monitor approved products that have been commercialized. The agency has the power to require changes in labeling or prohibit further marketing based on the results of post-marketing surveillance.

 

Satisfaction of these and other regulatory requirements typically takes several years, and the actual time required may vary substantially based upon the type, complexity and novelty of the product. Government regulation may delay or prevent marketing of potential products for a considerable period of time and impose costly procedures on our activities. We cannot be certain that the FDA or other regulatory agencies will approve any of our products on a timely basis, if at all. Success in preclinical or early-stage clinical trials does not assure success in later-stage clinical trials. Data obtained from preclinical and clinical activities are not always conclusive and may be susceptible to varying interpretations that could delay, limit or prevent regulatory approval. Even if a product receives regulatory approval, the approval may be significantly limited to specific indications or uses.

 

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Even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market. Delays in obtaining, or failures to obtain regulatory approvals would have a material adverse effect on our business.

 

The FDA’s policies may change, and additional government regulations may be enacted which could prevent or delay regulatory approval of our potential products. Increased attention to the containment of health care costs worldwide could result in new government regulations materially adverse to our business. We cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad.

 

We do not have a guarantee of patent term restoration and marketing exclusivity of the ingredients for our drugs even if we are granted FDA approval of our products.

 

The U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman) permits the FDA to approve Abbreviated New Drug Applications (ANDAs) for generic versions of innovator drugs, as well as NDAs with less original clinical data, and provides patent restoration and exclusivity protections to innovator drug manufacturers. The ANDA process permits competitor companies to obtain marketing approval for drugs with the same active ingredient and for the same uses as innovator drugs, but does not require the conduct and submission of clinical studies demonstrating safety and efficacy. As a result, a competitor could copy any of our drugs and only need to submit data demonstrating that the copy is bioequivalent to gain marketing approval from the FDA. Hatch-Waxman requires a competitor that submits an ANDA, or otherwise relies on safety and efficacy data for one of our drugs, to notify us and/or our business partners of potential infringement of our patent rights. We and/or our business partners may sue the company for patent infringement, which would result in a 30-month stay of approval of the competitor’s application. The discovery, trial and appeals process in such suits can take several years. If the litigation is resolved in favor of the generic applicant or the challenged patent expires during the 30-month period, the stay is lifted and the FDA may approve the application. Hatch-Waxman also allows competitors to market copies of innovator products by submitting significantly less clinical data outside the ANDA context. Such applications, known as “505(b)(2) NDAs” or “paper NDAs,” may rely on clinical investigations not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use and are subject to the ANDA notification procedures described above.

 

The law also permits restoration of a portion of a product’s patent term that is lost during clinical development and NDA review, and provides statutory protection, known as exclusivity, against FDA approval or acceptance of certain competitor applications. Restoration can return up to five years of patent term for a patent covering a new product or its use to compensate for time lost during product development and regulatory review. The restoration period is generally one-half the time between the effective date of an IND and submission of an NDA, plus the time between NDA submission and its approval (subject to the five-year limit), and no extension can extend total patent life beyond 14 years after the drug approval date. Applications for patent term extension are subject to U.S. Patent and Trademark Office (USPTO) approval, in conjunction with FDA. Approval of these applications takes at least nine months, and there can be no guarantee that it will be given at all.

 

Hatch-Waxman also provides for differing periods of statutory protection for new drugs approved under an NDA. Among the types of exclusivity are those for a “new molecular entity” and those for a new formulation or indication for a previously-approved drug. If granted, marketing exclusivity for the types of products that we are developing, which include only drugs with innovative changes to previously-approved products using the same active ingredient, would prohibit the FDA from approving an ANDA or 505(b)(2) NDA relying on our safety and efficacy data for three years. This three-year exclusivity, however, covers only the innovation associated with the original NDA. It does not prohibit the FDA from approving applications for drugs with the same active ingredient but without our new innovative change. These marketing exclusivity protections do not prohibit the FDA from approving a full NDA, even if it contains the innovative change.

 

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Item 1B.         Unresolved Staff Comments

 

None.

 

Item 2.            Properties

 

We currently rent approximately 1,000 square feet of office space in Rockville, Maryland for monthly rent of $3,002, and we rent approximately 1,600 square feet of office space in Ann Arbor, Michigan for monthly rent of $2,633. We believe our current offices will be adequate for the foreseeable future. 

 

Item 3.            Legal Proceedings

 

None.

 

Item 4.            Mine Safety Disclosures

 

Not applicable.

 

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PART II

 

Item 5.            Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchase of Equity Securities

 

Our common stock has traded on the NYSE MKT under the symbol “SYN” since February 16, 2012. Prior to this time, our common stock traded under the symbol “AEN” since October 16, 2008. The following table states the range of the high and low sales prices of our common stock for each of the calendar quarters during the years ended December 31, 2012 and December 31, 2011. These quotations represent inter-dealer prices, without retail mark-up, markdown, or commission, and may not represent actual transactions. The last price of our common stock as reported on the NYSE MKT on March 27, 2013 was $1.75 per share. As of March 27, 2013, there were approximately 352 stockholders of record of our common stock. This number does not include beneficial owners from whom shares are held by nominees in street name.

 

   High   Low 
YEAR ENDED DECEMBER 31, 2012          
Fourth quarter  $2.43   $1.60 
Third quarter  $2.41   $1.80 
Second quarter  $2.25   $1.51 
First quarter  $2.80   $1.27 
           
YEAR ENDED DECEMBER 31, 2011          
Fourth quarter  $1.42   $0.47 
Third quarter  $0.91   $0.57 
Second quarter  $2.13   $0.80 
First quarter  $1.85   $1.04 

 

Dividend Policy

 

We have never paid any cash dividends on our common stock to date, and do not anticipate paying such cash dividends in the foreseeable future. Whether we declare and pay dividends is determined by our Board of Directors at their discretion, subject to certain limitations imposed under Nevada corporate law. The timing, amount and form of dividends, if any, will depend on, among other things, our results of operations, financial condition, cash requirements and other factors deemed relevant by our Board of Directors.

 

Equity Compensation Plan Information

 

See Item 12 – Executive compensation for equity compensation plan information.

 

Recent Sales of Unregistered Securities

 

In September 26, 2012, we issued a performance warrant as compensation for a consulting agreement that we had entered into for a financial communications program.  The performance warrant is exercisable for 250,000 shares of our common stock based on achievement of certain stock price milestones at an exercise price equal to the market price of our common stock on the date of execution of the agreement. Upon initiation of the program, 50,000 of the performance warrants vested.   The warrant was issued in reliance on the exemption from registration afforded by Section 4(a)(2) of  the Securities Act of 1933.

 

All other sales of unregistered securities have been previously reported.

 

Item 6.            Selected Financial Data

 

Not applicable because we are a smaller reporting company.

 

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Item 7.            Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion of our financial condition and results of operations should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2012 found in this report. In addition to historical information, the following discussion contains forward-looking statements that involve risks, uncertainties and assumptions. Where possible, we have tried to identify these forward looking statements by using words such as “anticipate,” “believe,” “intends,” or similar expressions. Our actual results could differ materially from those anticipated by the forward-looking statements due to important factors and risks including, but not limited to, those set forth under “Risk Factors” in Part I, Item 1A of this Report.

  

Overview

 

We are a biotechnology company focused on the development of biologics for the prevention and treatment of serious infectious diseases. We are developing an oral enzyme for the prevention of C. difficile infections, and a series of monoclonal antibody therapies for the treatment of Pertussis and Acinetobacter infections. In addition, we are developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis and cognitive dysfunction in multiple sclerosis, and have partnered the development of a treatment for fibromyalgia.

 

Product Pipeline:

  

 

Summary of Infectious Disease Programs:

 

•Clostridium difficile (C. difficile) infections: In November 2012, we acquired a series of oral beta-lactamase enzymes (P1A, P2A and P3A) and related assets targeting the prevention of C. difficile infections (CDI), the leading cause of hospital acquired infections (HAI), that generally occurs secondary to treatment with intravenous antibiotics. The acquired assets include a pre-Investigational New Drug (IND) package for P3A (SYN-004), Phase I and Phase II clinical data for P1A, manufacturing processes and data, and a portfolio of issued and pending U.S. and international patents intended to support an IND and Biologic License Application (BLA) with the FDA. Utilizing this portfolio of assets, we intend to develop a proprietary oral beta-lactamase enzyme product candidate, SYN-004, previously known as IPSAT P3A. When co-administered with certain intravenous beta-lactam antibiotics, it is expected that SYN-004 can degrade the antibiotic that is excreted in the gastrointestinal (GI) tract, thus preserving the natural balance of the patient's microflora, and preventing opportunistic infections including CDI. Beta-lactam antibiotics are a mainstay in hospital infection management and include the commonly used penicillin and cephalosporin classes of antibiotics. According to GlobalData, an estimated 8.7 million Americans were administered intravenous beta-lactam antibiotics in 2011.

 

•Pertussis: In December 2012, in collaboration with Intrexon Corporation (Intrexon), we initiated development of a monoclonal antibody (mAb) therapy for the treatment of Pertussis infections, more commonly known as whooping cough. We are developing a mAb therapy, SYN-005, designed to target and neutralize the pertussis toxin, in order to reduce the mortality rate in infants and potentially shorten the duration of chronic cough in afflicted adults. To further the development of this potential therapy for Pertussis, we entered into an agreement with The University of Texas at Austin to license the rights to certain research and pending patents related to pertussis antibodies. According to the World Health Organization, each year, B. pertussis infection causes an estimated 294,000 deaths worldwide, primarily among young, unvaccinated children.

 

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•Acinetobacter infections: In September 2012, in collaboration with Intrexon, we initiated efforts to develop a mAb therapy for the treatment of Acinetobacter infections. Many strains of Acinetobacter are multidrug-resistant and pose an increasing global threat to hospitalized patients, wounded military personnel and those affected by natural disasters. A treatment for Acinetobacter infections represents a multi-billion dollar market opportunity.

 

Summary of Multiple Sclerosis Program:

 

•TrimestaTM (oral estriol) is being developed as an oral once-daily treatment for relapsing-remitting multiple sclerosis (MS) in women. Patient enrollment is complete in this two-year, randomized, double-blind, placebo-controlled Phase II clinical trial being conducted at 15 centers in the U.S. The primary endpoint is relapse rate at two years, with top-line results expected in 1H 2014. This trial is supported by grants exceeding $8 million, which should be sufficient to fund the trial through completion. Current sales of injectable disease-modifying therapies for MS are estimated at $8.9 billion annually.

 

•TrimestaTM is also being developed for the treatment of cognitive dysfunction in female MS patients. This 12-month randomized, double-blind, placebo-controlled Phase II clinical trial is being conducted at University of California, Los Angeles (UCLA). The primary endpoint is the effect on cognitive function as assessed by Paced Auditory Serial Addition Test (PASAT). Patient enrollment is ongoing. The majority of the costs of this trial are being funded by grants from foundations and charitable organizations and we have pledged approximately $500,000 to UCLA to partially fund this trial payable over three years. An estimated 50-65% of MS patients are expected to develop disabilities due to cognitive dysfunction and there is currently no approved treatment.

 

Summary of Fibromyalgia Program:

 

•EffirmaTM (flupirtine) is being developed for the treatment of fibromyalgia by Meda AB (Meda), a multi-billion dollar international pharmaceutical company. On May 6, 2010, we entered into a sublicense agreement with Meda covering all of our patents’ rights on the use of flupirtine for fibromyalgia in the U.S., Canada and Japan. The sublicense agreement provides that all ongoing and future development costs are to borne by Meda and we are entitled to receive certain payments if milestones are achieved and royalties on sales. According to Meda’s 2012 Year-End Report filed in February 2013, Meda has received the go-ahead from the FDA to conduct a Phase II proof of concept study for the treatment of fibromyalgia. Meda also announced that the randomized, double-blind, placebo and active-controlled study of patients with fibromyalgia will be conducted at 25 clinics in the U.S. Based on an estimated annual price of $1,200 per fibromyalgia patient, we estimate that the total market potential in the U.S. is $6 billion.

 

 

To prioritize our focus on the development of product candidates for the prevention and treatment of serious infectious diseases, we do not intend to pursue further development of our previously announced program for pulmonary arterial hypertension. However, we are currently in discussions with Intrexon to substitute this program with an alternate program better suited to our current objectives and focus.

 

In order to further prioritize our focus, we have elected to discontinue further development of AEN-100 for the treatment of amyotrophic lateral sclerosis. However, we are currently seeking development partners for our zinc-based intellectual property and assets including, AEN-100.

 

Recent Developments

 

On December 19, 2012, we entered into a Patent License Agreement (the “License Agreement”) with The University of Texas at Austin (the “University”) for the exclusive license of the right to use, develop, manufacture, market and commercialize certain research and patents related to Pertussis (more commonly known as whooping cough) antibodies developed in the lab of Dr. Jennifer A. Maynard, Assistant Professor of Chemical Engineering. In connection with the License Agreement, we and the University also entered into a Sponsored Research Agreement pursuant to which the University will perform certain research work related to pertussis under the direction of Dr. Jennifer Maynard and we will obtain certain rights to patents and technology developed during the course of such research.

 

On November 28, 2012, a closing was held for the transaction contemplated by the Asset Purchase Agreement (the “Prev Agreement”) we entered into with Prev ABR LLC (“Prev”), pursuant to which we acquired the C. diff program assets of Prev, including pre-Investigational New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and pending U.S. and international patents.  Pursuant to the Prev Agreement, we paid Prev an initial cash payment of $100,000 upon execution of the Prev Agreement and at closing paid an additional cash payment of $135,000 and issued 625,000 unregistered shares of our common stock to Prev. In addition, upon the achievement of the milestones set forth below, Prev may be entitled to receive additional consideration payable 50% in cash and 50% in our stock, subject to Prev’s option to receive the entire payment in shares of our stock, with the exception of the first milestone payments to be paid in cash: (i) upon commencement of an IND; (ii) upon commencement of a Phase I clinical trial; (iii) upon commencement of a Phase II clinical trial; (iv) upon commencement of a Phase III clinical trial; (v) upon Biologic License Application (BLA) filing in the U.S. and for territories outside of the U.S. (as defined in the Prev Agreement); and (vi) upon BLA approval in the U.S. and upon approval in territories outside the-U.S.  The future stock issuances are subject to prior approval of the NYSE MKT, LLC. No royalties are payable to Prev under the Prev Agreement. The Prev Agreement also provides that Prev has a right to the return to it of all assets acquired by us under the Prev Agreement if on or prior to the date that is (i) thirty (30) months after the execution of the Prev Agreement, we have not initiated toxicology studies in non-rodent models or (ii) thirty six (36) months have not filed an IND under the program related to the assets and such failure is not due to action or inaction of Prev or breach of its representations or warranties or covenants or if there is a change of control as defined in the Prev Agreement and after such change of control the assets are not further developed; provided however that such thirty (30) and thirty six (36) month periods can be extended by us for an additional twelve (12) months upon payment of a cash milestone payment.

 

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On October 30, 2012, we completed a private placement (the “October 2012 Private Placement”) with certain accredited investors, pursuant to which we sold an aggregate of 6,750,000 shares of our common stock at a price per share of $1.60 (the “Common Shares”) for aggregate gross proceeds of $10.8 million and net proceeds of $10.1 million. In connection with the October 2012 Private Placement, we filed a registration statement with the SEC which was declared effective on December 20, 2012 for the resale of our common stock owned by certain of the purchasers in the October 2012 Private Placement. In connection with the October 2012 Private Placement, we also entered into an agreement with a certain purchaser that is an affiliate of Intrexon (the “Joinder Agreement”) pursuant to which such purchaser agreed to be bound by the terms of and join Intrexon as a party to its registration rights agreement with us entered into in connection with the Second Channel Agreement.

 

Griffin Securities, Inc. (“Griffin”) served as the placement agent for the October 2012 Private Placement. In consideration for services rendered by Griffin in the October 2012 Private Placement, we (i) paid to Griffin cash commissions equal to 6.0% of the gross proceeds received in the October 2012 Private Placement, (ii) issued to Griffin, or its designee, the Agent Warrants, which are five-year warrants to purchase 635,855 shares of our common stock with an exercise price of $1.60 per share; and (iii) reimbursed Griffin for its reasonable actual out-of-pocket expenses incurred in connection with the October 2012 Private Placement, including reasonable legal fees and disbursements. The common stock underlying the Agent Warrants was registered under the registration statement declared effective on December 20, 2012.

 

On August 6, 2012, we expanded our relationship with Intrexon and entered into a Second Channel Agreement with Intrexon (the “Second Channel Agreement”) that governs an “exclusive channel collaboration” arrangement in which we will use Intrexon’s technology relating to the identification, design and production of human antibodies and DNA vectors for the development and commercialization of a series of monoclonal antibody therapies for the treatment of certain serious infectious diseases (the “Program”). The Second Channel Agreement establishes committees comprised of our and Intrexon representatives that will govern activities related to the Program in the areas of project establishment, chemistry, manufacturing and controls, clinical and regulatory matters, commercialization efforts and intellectual property. On October 16, 2012, a closing was held for the transaction contemplated by the Second Channel Agreement. Pursuant to the terms of a Stock Issuance Agreement with Intrexon (the “Second Stock Purchase Agreement”), we issued 3,552,210 shares of our common stock, $0.001 par value, which issuance is also deemed paid in consideration for the execution and delivery of the Second Channel Agreement, dated August 6, 2012, between ourselves and Intrexon. We also agreed to register the shares issued to Intrexon in accordance with the First Amendment to Registration Rights Agreement.

 

On February 15, 2012, upon stockholder approval, we amended our Articles of Incorporation to change our name to Synthetic Biologics, Inc. Our common stock continues trade on the NYSE MKT (formerly the NYSE Amex and American Stock Exchange), under the symbol “SYN”. Prior to this time and since October 16, 2008, our name was Adeona Pharmaceuticals, Inc. and we traded on the NYSE MKT stock exchange under the symbol “AEN”. We are incorporated in the State of Nevada. We maintain principal executive offices at 155 Gibbs Street, Suite 412, Rockville, Maryland 20850, and we maintain an administrative and finance office in Ann Arbor, Michigan.

 

On December 21, 2011, we announced that the Board of Directors had taken several actions to prioritize our focus on our entry into the emerging field of synthetic biology. In connection with the change in business focus on March 8, 2012, we entered into a Membership Interest Purchase Agreement, and certain related agreements, pursuant to which we sold all of our interest in the Adeona Clinical Laboratory (the “Lab”) to Hartlab, LLC, an entity controlled by the Lab’s former owner, in consideration for (i) the immediate assignment of the Lab’s outstanding accounts receivable up through the date of closing, plus (ii) Seven Hundred Thousand Dollars ($700,000) payable pursuant to the terms of a two-year non-recourse promissory note secured by all of the assets of the Lab.

 

On November 18, 2011, we entered into a Channel Agreement with Intrexon (the “Initial Channel Agreement”) that governs an “exclusive channel collaboration” arrangement in which we initially intended to use Intrexon’s technology directed towards the production of PGIS, through the use of in vivo conditionally regulated embedded controllable bioreactors for the treatment of PAH. The Initial Channel Agreement establishes committees comprised of our and Intrexon representatives that will govern activities related to the PAH program in the areas of project establishment, chemistry, manufacturing and controls, clinical and regulatory matters, commercialization efforts and intellectual property. As consideration for execution of the Initial Channel Agreement, we entered into a Stock Purchase Agreement with Intrexon (the Initial Stock Purchase Agreement”) pursuant to which we issued to Intrexon a number of shares of our common stock equal to 9.995% of the number of shares of our common stock issued and outstanding following and giving effect to such issuance (the “First Tranche”) at a purchase price equal to the $0.001 par value of such shares, which issuance was deemed paid in consideration for the execution and delivery of the Initial Channel Agreement. We also agreed to issue additional shares of our common stock to Intrexon upon dosing of the first patient in a Phase II clinical trial sponsored by us in the U.S., or similar study as the parties may agree in a country other than the U.S.

 

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Since our inception in January 2001, our efforts and resources have been focused primarily on acquiring and developing our product candidates, our clinical trials, raising capital and recruiting personnel. As of June 30, 2010, we emerged from the development stage after entering into a sublicense agreement with Meda AB and receiving an up-front payment of $2.5 million. We consider this sublicense agreement to be an indication that we commenced our principal operations.

 

To date, we have financed our operations primarily through public and private sales of our common stock, and we expect to continue to seek to obtain the required capital in a similar manner. We have incurred an accumulated deficit of $68.9 million through December 31, 2012. We cannot provide any assurance that we will be able to achieve profitability on a sustained basis, if at all, obtain the required funding, obtain the required regulatory approvals, or complete additional corporate partnering or acquisition transactions.

 

Critical Accounting Policies

 

The preparation of our consolidated financial statements in accordance with U.S. generally accepted accounting principles (GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, net revenues and expenses, and related disclosures. We believe our estimates and assumptions are reasonable; however, actual results and the timing of the recognition of such amounts could differ from these estimates.

 

There are accounting policies that we believe are significant to the presentation of our consolidated financial statements. The most significant accounting policies relate to stock-based compensation, revenue recognition and accounts receivable.

 

Stock-Based Compensation

 

Calculating stock-based compensation expense requires the input of highly subjective assumptions. We apply the Black-Scholes option pricing model to determine the fair value of our stock options. Inherent in this model are assumptions related to expected stock-price volatility, option life, risk-free interest rate and dividend yield. We estimate the volatility of our common stock at the date of grant based on historical volatility. We estimate the expected life of our option using the contractual term of the option. The risk-free interest rate is based on the U.S. Treasury zero-coupon yield curve on the grant date for a maturity similar to the expected life of the options. The dividend rate is based on our historical rate, which we anticipate to remain at zero. The assumptions used in calculating the fair value of stock options represent our best estimates, however these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and different assumptions are used, the stock-based compensation expense could be materially different in the future. In addition, we are required to estimate the expected forfeiture rate and only recognize expense for those stock options expected to vest over the service period.

 

Revenue Recognition

 

We record revenue when all of the following have occurred: (1) persuasive evidence of an arrangement exists, (2) the service is completed without further obligation, (3) the sales price to the customer is fixed or determinable, and (4) collectability is reasonably assured.  We recognize milestone payments or upfront payments that have no contingencies as revenue when payment is received.  Our primary streams of revenue are license revenue and laboratory revenue.

 

License Revenues

 

Our licensing agreements may contain multiple elements, such as non-refundable up-front fees, payments related to the achievement of particular milestones and royalties. Fees associated with substantive at risk performance-based milestones are recognized as revenue upon completion of the scientific or regulatory event specified in the agreement. When we have substantive continuing performance obligations under an arrangement, revenue is recognized over the performance period of the obligations using a time-based proportional performance approach. Under the time-based method, revenue is recognized over the arrangement’s estimated performance period based on the elapsed time compared to the total estimated performance period. Revenue recognized at any point in time is limited to the amount of non-contingent payments received or due. When we have no substantive continuing performance obligations under an arrangement, we recognize revenue as the related fees become due.

 

Revenues from royalties on third-party sales of licensed technologies are generally recognized in accordance with the contract terms when the royalties can be reliably determined and collectability is reasonably assured.

 

Research and Development Costs

 

We expense research and development costs associated with developmental products not yet approved by the FDA to research and development expense as incurred. Research and development costs consist primarily of license fees (including upfront payments), milestone payments, manufacturing costs, salaries, stock-based compensation and related personnel costs, fees paid to consultants and outside service providers for laboratory development, legal expenses resulting from intellectual property prosecution and other expenses relating to the design, development, testing and enhancement of our product candidates.

  

Results of Operations

 

Year Ended December 31, 2012 and 2011

 

General and Administrative Expenses

 

General and administrative expenses increased to $5.0 million for the year ended December 31, 2012, from $2.6 million for the year ended December 31, 2011. This increase of 94% is primarily the result of additional employee costs, expanded investor relation activities and outside legal fees related to various Securities and Exchange Commission issues related to Berman & Company P.A.’s failure to follow proper partner rotation procedures. The charge relating to stock-based compensation expense was $1.5 million for the year ended December 31, 2012, compared to $919,000 for the year ended December 31, 2011. This increase is due to stock options granted to new executive officers. The stock-based compensation for the year ended December 31, 2011 includes a charge of $398,000 relating to the modification of certain stock options, prior to expiration, held by a member of the Board of Directors.

 

29
 

 

Research and Development Expenses

 

Research and development expenses increased to $12.3 million for the year ended December 31, 2012, from $3.3 million for the year ended December 31, 2011. This increase of 268% is primarily the result of recording the fair value ($7.8 million) of the common stock issued to Intrexon as consideration for the Exclusive Channel Collaboration Agreement and the fair value ($1.2 million) of the common stock issued for the acquisition of the C. diff program assets of Prev ABR LLC. These are non-cash charges. The charge relating to share-based compensation expense was $400,000 for the year ended December 31, 2012, compared to $54,000 for the year ended December 31, 2011.

 

Other Income (Expense), net

 

Other income was $15,000 for the year ended December 31, 2012, compared to other expense of $1.7 million for the year ended December 31, 2011. Other expense for the year ended December 31, 2011, includes $1.7 million relating to the estimated fair value of the warrants associated with the January 2011 and April 2011 financings, adjusted for the change in their fair value at December 31, 2011.

 

Loss from Continuing Operations

 

Our loss from continuing operations for the year ended December 31, 2012, was $17.3 million, or $0.50 per common share, compared to $7.6 million, or $0.27 per common share for the year ended December 31, 2011.

 

Income (Loss) from Discontinued Operations

 

Our income from discontinued operations was $216,000, or $0.01 per common share for the year ended December 31, 2012, compared to a net loss of $523,000, or $0.02 per common share for the year ended December 31, 2011. On March 8, 2012, we entered into a Membership Interest Purchase Agreement, and certain related agreements, pursuant to which we sold all of our interest in the Lab to Hartlab, LLC. This resulted in the classification of the Lab as discontinued operations. See Note 3 - Discontinued Operations of Adeona Clinical Laboratory and Note Receivable for summarized statement of operations data for the years ended December 31, 2012 and 2011.

 

Liquidity and Capital Resources

 

We have financed our operations since inception primarily through proceeds from equity financings, corporate partnering license fees, laboratory revenues and miscellaneous equipment sales.

 

On October 31, 2012, we completed a private placement financing of 6,750,000 shares of our common stock, par value of $.001 per share, at a price per share of $1.60. We raised gross proceeds of $10.8 million, before estimated offering expenses of $680,000, which includes placement agent fees. In addition to the fee, the placement agent received warrants to purchase 635,855 shares of common stock.

 

Our cash totaled $10.0 million at December 31, 2012, an increase of $3.3 million from December 31, 2011. During the year ended December 31, 2012, the primary sources of cash were net proceeds from the issuances of common stock in a private placement financing of $10.2 million and stock option exercises of $127,000 and warrant exercises of $2.0 million. The primary use of cash during the year ended December 31, 2012 was for working capital requirements. 

 

Our cash totaled $6.7 million at December 31, 2011, an increase of $4 million from December 31, 2010. During the year ended December 31, 2011, the primary sources of cash were net proceeds from the issuances of common stock to institutional investors of $7 million and stock option and warrant exercises of $15,000. The primary use of cash during the year ended December 31, 2011 was for working capital requirements. 

 

As of March 27, 2013, our cash balance was approximately $8.7 million.

  

Our continued operations will primarily depend on whether we are able to generate revenues and profits through partnerships, joint ventures and/or raise additional funds through various potential sources, such as license fees from a potential corporate partner, equity and debt financing. Such additional funds may not become available on acceptable terms and there can be no assurance that any additional funding that we do obtain will be sufficient to meet our needs in the long term. We will continue to fund operations from cash on hand and through the similar sources of capital previously described. We can give no assurances that any additional capital that we are able to obtain will be sufficient to meet our needs.

 

30
 

 

Current and Future Financing Needs

 

We have incurred an accumulated deficit of $68.9 million through December 31, 2012. With the exception of the quarter ended June 30, 2010, we have incurred negative cash flow from operations since we started our business. We have spent, and expect to continue to spend, substantial amounts in connection with implementing our business strategy, including our planned product development efforts, our clinical trials, and our research and discovery efforts.

 

Based on our current plans, we believe that our cash will be sufficient to enable us to meet our planned operating needs for at least the next 12 months.

 

However, the actual amount of funds we will need to operate is subject to many factors, some of which are beyond our control. These factors include the following:

 

·the progress of our research activities;
·the number and scope of our research programs;
·the progress of our preclinical and clinical development activities;
·the progress of the development efforts of parties with whom we have entered into research and development agreements;
·our ability to maintain current research and development licensing arrangements and to establish new research and development and   licensing   arrangements;
·our ability to achieve our milestones under licensing arrangements;
·the costs involved in prosecuting and enforcing patent claims and other intellectual property rights;
·the costs and timing of regulatory approvals; and
·profitability of our clinical laboratory diagnostic and microbiology services business.

 

We have based our estimate on assumptions that may prove to be wrong. We may need to obtain additional funds sooner or in greater amounts than we currently anticipate. Potential sources of financing include strategic relationships, public or private sales of our shares or debt and other sources. We may seek to access the public or private equity markets when conditions are favorable due to our long-term capital requirements. We do not have any committed sources of financing at this time, and it is uncertain whether additional funding will be available when we need it on terms that will be acceptable to us, or at all. If we raise funds by selling additional shares of common stock or other securities convertible into common stock, the ownership interest of our existing stockholders will be diluted. If we are not able to obtain financing when needed, we may be unable to carry out our business plan. As a result, we may have to significantly limit our operations and our business, financial condition and results of operations would be materially harmed.

 

License and Contractual Agreement Obligations

 

Below is a table of our contractual obligations for the years 2013 through 2017 as of December 31, 2012 (in thousands).

 

   Year ended December 31,     
   2013   2014   2015   2016   2017   Total 
License Agreements  $60   $60   $35   $10   $10   $175 
Sponsored Research Agreement   227    -    -    -    -    227 
Lease Agreements   48    6    -    -    -    54 
Total  $335   $66   $35   $10   $10   $456 

 

Additional In-Licensed Programs

 

We may enter into additional license agreements relating to new product candidates.

 

31
 

 

Item 7A.         Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable because we are a smaller reporting company.

 

32
 

 

Item 8.            Financial Statements and Supplemental Data

 

  Page
Reports of Independent Registered Public Accounting Firms 34
Consolidated Balance Sheets 36
Consolidated Statements of Operations 37
Consolidated Statements of Changes in Stockholders’ Equity 38
Consolidated Statements of Cash Flows 39
Notes to Consolidated Financial Statements 40

 

33
 

 

Report of Independent Registered Public Accounting Firm

 

Board of Directors and Stockholders

Synthetic Biologics, Inc.

Rockville, Maryland

 

We have audited the accompanying consolidated balance sheet of Synthetics Biologics, Inc. as of December 31, 2012 and the related consolidated statements of operations, changes in stockholders’ equity, and cash flows for the year ended December 31, 2012. These financial statements are the responsibility of Synthetic Biologic Inc.’s management. Our responsibility is to express an opinion on these financial statements based on our audit.

 

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

 

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Synthetic Biologics, Inc. at December 31, 2012, and the results of its operations and its cash flows for the year ended December 31, 2012, in conformity with accounting principles generally accepted in the United States of America.

 

/s/ BDO USA, LLP

 

BDO USA, LLP

Boston, Massachusetts

April 16, 2013

 

34
 

 

 

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Stockholders of:

Synthetic Biologics, Inc.

 

We have audited the accompanying consolidated balance sheets of Synthetic Biologics, Inc. and Subsidiaries as of December 31, 2011 and 2010 and the related consolidated statements of operations, stockholders’ equity and cash flows for the years ended December 31, 2011 and 2010. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated 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 audits 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 the 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 includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements.  An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.  We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the consolidated financial statements referred to above present fairly in all material respects, the consolidated financial position of Synthetic Biologics, Inc. and Subsidiaries as of December 31, 2011 and 2010, and the related consolidated statements of operations, stockholders’ equity and cash flows for the years ended December 31, 2011 and 2010, in conformity with accounting principles generally accepted in the United States of America.

 

 

Berman & Company, P.A.  

 

  
Boca Raton, Florida  
May 11, 2012  

 

 

 

35
 

   

Synthetic Biologics, Inc. and Subsidiaries

Consolidated Balance Sheets

(In thousands except share amounts)

 

 

   December 31, 2012   December 31, 2011 
Assets          
           
Current Assets:          
Cash  $9,954   $6,678 
Accounts receivable – net   -    405 
Prepaid expenses and other current assets   2,509    16 
Assets of discontinued operations   -    23 
Total Current Assets   12,463    7,122 
           
Property and equipment, net   223    323 
           
Long-term note receivable   700    - 
           
Deposits and other assets   37    31 
Total Assets  $13,423   $7,476 
           
Liabilities and Stockholders' Equity          
Current Liabilities:          
Accounts payable  $395   $388 
Accrued liabilities   -    29 
Total Current Liabilities   395    417 
Total Liabilities   395    417 
           
Stockholders' Equity:          
Preferred stock,  $0.001 par value; 10,000,000 shares authorized, none  issued and outstanding   -    - 
Common stock,  $0.001 par value; 100,000,000 shares authorized, 44,444,230  issued and 44,362,748 outstanding and 31,374,002  issued and 31,292,520 outstanding   44    31 
Additional paid-in capital   81,925    58,901 
Accumulated deficit   (68,941)   (51,873)
Total Stockholders' Equity   13,028    7,059 
Total Liabilities and Stockholders' Equity  $13,423   $7,476 

 

See accompanying notes to consolidated financial statements

 

36
 

 

Synthetic Biologics, Inc. and Subsidiaries

Consolidated Statements of Operations

(In thousands, except share and per share amounts)

 

   For the years ended December 31, 
   2012   2011 
Operating Costs and Expenses:          
General and administrative  $5,012   $2,588 
Research and development   12,287    3,340 
Total Operating Expenses   17,299    5,928 
           
Loss from Operations   (17,299)   (5,928)
           
Other Income (Expense):          
Warrant expense   -    (1,492)
Change in fair value of warrant liability   -    (242)
Interest income   33    14 
Other income (expense)   (18)   22 
Total Other Income (Expense), net   15    (1,698)
           
Loss from Continuing Operations   (17,284)   (7,626)
           
Income (Loss) from Discontinued Operations   216    (523)
           
Net Loss and Comprehensive Loss  $(17,068)  $(8,149)
           
Net Income (Loss) Per Share  - Basic and Dilutive:          
Continuing operations  $(0.50)  $(0.27)
Discontinued operations   0.01    (0.02)
           
Net Income (Loss) Per Share  $(0.49)  $(0.29)
           
Weighted average number of shares outstanding during the period - Basic and Dilutive   34,896,592    27,710,428 

 

See accompanying notes to consolidated financial statements

 

37
 

 

Synthetic Biologics, Inc. and Subsidiaries

Consolidated Statements of Changes in Stockholders' Equity

(In thousands, except share amounts)

 

   Common Stock $0.001 Par Value   Additional Paid-   Accumulated   Total Stockholders' 
   Shares   Amount   in Capital   Deficit   Equity 
Balance, December 31, 2010   23,338,707   $23   $47,280   $(43,724)  $3,579 
                          
Stock-based compensation   -    -    973    -    973 
Issuance of common stock for employee compensation   73,585    -    94    -    94 
Issuance of common stock for exclusive channel collaboration agreement   3,123,558    3    1,684    -    1,687 
Issuance of common stock for consulting fees   171,796    -    165    -    165 
Issuance of common stock for stock options and warrants exercised   38,948    -    15    -    15 
Issuance of common stock , net of issuance costs of  $539   4,545,926    5    6,956    -    6,961 
Warrant liability reclassified to stockholders' equity   -    -    1,734    -    1,734 
Net loss   -    -    -    (8,149)   (8,149)
                          
Balance, December 31, 2011   31,292,520    31    58,901    (51,873)   7,059 
                          
Stock-based compensation   -    -    1,852    -    1,852 
Issuance of common stock for exclusive channel collaboration agreement   3,552,210    3    7,811    -    7,814 
Issuance of common stock for acquisition of program assets   625,000    1    1,168    -    1,169 
Issuance of common stock for stock options and warrants exercised   2,143,018    2    2,080    -    2,082 
Issuance of common stock, net of issuance costs of $680   6,750,000    7    10,113    -    10,120 
Net loss   -    -    -    (17,068)   (17,068)
                          
Balance, December 31, 2012   44,362,748   $44   $81,925   $(68,941)  $13,028 

 

See accompanying notes to consolidated financial statements

 

38
 

 

Synthetic Biologics, Inc. and Subsidiaries

Consolidated Statements of Cash Flows

(In thousands)

 

   Year ended December 31, 
   2012   2011 
Cash Flows From Operating Activities:        
Net Loss  $(17,068)  $(8,149)
Adjustments to reconcile net loss to net cash used in operating activities:       
Stock-based compensation   1,851    973 
Stock issued as compensation   -    94 
Stock issued for consulting fees   -    165 
Stock issued for exclusive channel collaboration agreement   7,815    1,684 
Stock issued for acquisition of program assets   1,169    - 
Warrant expense   -    1,492 
Change in fair value of warrant liability   -    242 
Depreciation   63    144 
Provision for uncollectible accounts receivable   442    414 
Gain on sale of discontinued operations   (677)   - 
Amortization of premium on investments   -    57 
Loss on sale of short-term investments   -    20 
Loss on sale of equipment   -    6 
Impairment on loss of equipment   47    - 
Gain on the settlement of accounts payable   -    (63)
Changes in operating assets and liabilities:          
Accounts receivable   14    (480)
Prepaid expenses and other current assets   (2,544)   327 
Deposits and other assets   (6)   60 
Assets of discontinued operations   -    191 
Accounts payable   7    153 
Accrued liabilities   (29)   (181)
Liabilities of discontinued operations   -    (24)
Net Cash Used In Operating Activities   (8,916)   (2,875)
           
Cash Flows From Investing Activities:          
Purchase of short-term investments   -    (4,370)
Proceeds from short-term investments   -    4,293 
Purchase of property and equipment   (10)   - 
Proceeds from the sale of equipment   -    2 
Net Cash Used In Investing Activities   (10)   (75)
           
Cash Flows From Financing Activities:          
Proceeds from issuance of common stock for stock option and warrant exercises   2,082    15 
Proceeds from issuance of common stock for exclusive channel collaboration agreement   -    3 
Proceeds from the issuance of common stock, net of issuance costs of $680 and $539, respectively   10,120    6,961 
Net Cash Provided By  Financing Activities   12,202    6,979 
           
Net increase in cash   3,276    4,029 
           
Cash at beginning of year   6,678    2,649 
           
Cash at end of year  $9,954   $6,678 
           
Supplemental disclosures of cash flow information:          
Cash paid for interest  $-   $- 
Cash paid for taxes  $-   $- 
Supplemental disclosures of non-cash investing and financing activities:          
Reclassification of warrant liability to additional paid-in-capital  $-   $1,734 

 

See accompanying notes to consolidated financial statements

 

39
 

 

Synthetic Biologics, Inc. and Subsidiaries

Notes to Consolidated Financial Statements

December 31, 2012 and 2011

 

  1. Organization and Nature of Operations and Basis of Presentation

 

Description of Business

 

Synthetic Biologics, Inc. (the “Company” or “Synthetic Biologics”) is a biotechnology company focused on the development of biologics for the prevention and treatment of serious infectious diseases. The Company is developing an oral enzyme for the prevention of C. difficile infections, and a series of monoclonal antibody therapies for the treatment of Pertussis and Acinetobacter infections. In addition, the Company is developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis and cognitive dysfunction in multiple sclerosis, and has partnered the development of a treatment for fibromyalgia.

 

Therapeutic Area   Product Candidate   Status
         
Relapsing-remitting MS  

Trimesta

(oral estriol)

   Patients fully enrolled in Phase II clinical trial;
dosing and monitoring underway
         
Cognitive dysfunction in MS  

Trimesta

(oral estriol)

   Patient enrollment underway in Phase II
clinical trial
         
C. difficile infection prevention   SYN-004
(monoclonal antibody)		  

Series of oral enzyme candidates; first generation candidate (formerly known as P1A) is in Phase II;

next generation candidate, SYN-004, (formerly known as P3A) is in preclinical

         
Pertussis   SYN-005
(monoclonal antibody)		   Preclinical; Collaborations with Intrexon and The University of Texas at Austin
         
Acinetobacter infection   SYN-001
(monoclonal antibody)		   Discovery; Collaboration with Intrexon
       
Fibromyalgia   Effirma
(oral flupirtine)		   Partnered with Meda AB

 

To prioritize the Company’s focus on the development of product candidates for the prevention and treatment of serious infectious diseases, it does not intend to pursue further development of the previously announced program for pulmonary arterial hypertension. However, the Company is currently in discussions with Intrexon to substitute this program with an alternate program better suited to its current objectives and focus.

 

In order to further prioritize the Company’s focus, it has elected to discontinue further development of AEN-100 for the treatment of amyotrophic lateral sclerosis. However, the Company is currently seeking development partners for its zinc-based intellectual property and assets including, AEN-100.

 

Basis of Presentation and Corporate Structure

 

As of December 31, 2012, the Company had seven subsidiaries, Pipex Therapeutics, Inc. (“Pipex Therapeutics”), Effective Pharmaceuticals, Inc. (“EPI”), Solovax, Inc. (“Solovax”), CD4 Biosciences, Inc. (“CD4”), Epitope Pharmaceuticals, Inc. (“Epitope”), Healthmine, Inc. (“Healthmine”) and Putney Drug Corp. (“Putney”). As of December 31, 2012, Pipex Therapeutics, EPI, Healthmine and Putney are wholly owned and Solovax, CD4 and Epitope are majority-owned.

 

For financial reporting purposes, the outstanding common stock of the Company is that of Synthetic Biologics, Inc. All statements of operations, stockholders’ equity and cash flows for each of the entities are presented as consolidated. All subsidiaries were formed under the laws of the State of Delaware on January 8, 2001, except for EPI, which was incorporated in Delaware on December 12, 2000, Epitope which was incorporated in Delaware in January of 2002, Putney which was incorporated in Delaware in November of 2006 and Healthmine which was formed in Delaware in December of 2007.

 

40
 

 

On March 8, 2012, the Company sold all of its interest in Adeona Clinical Laboratory, LLC (the “Lab”) to Hartlab, LLC, an entity controlled by the Lab’s former owner, in consideration for (i) the immediate assignment of the Lab’s outstanding accounts receivable up through the date of closing, plus (ii) $700,000 payable pursuant to the terms of a two-year non-recourse promissory note secured by all the assets of the Lab. Accordingly, this business has been presented in the consolidated financial statements as discontinued operations. This transaction is described in more detail in Note 3 – Discontinued Operations of Adeona Clinical Laboratory.

 

  2. Summary of Significant Accounting Policies

 

Principles of Consolidation

 

All inter-company transactions and accounts have been eliminated in consolidation.

 

Emerging from the Development Stage

 

During the second quarter of 2010, the Company emerged from the development stage.   A development-stage enterprise is one in which planned principle operations have not commenced or if its operations have commenced, there has been no significant revenue. On May 6, 2010, the Company entered into a Sublicense Agreement (the “Meda Agreement”) with Meda AB of Sweden (“Meda”) and received an up-front payment of $2.5 million. The execution of the Meda Agreement combined with revenues from Adeona Clinical Laboratory were an indication of the commencement of principal operations, and therefore development-stage reporting was no longer required.

 

Use of Estimates

 

The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the U.S.A. requires management to make estimates and assumptions that affect the reported amounts reported in the consolidated financial statements and accompanying notes. Such estimates and assumptions impact, among others, the following: the amount allocated to goodwill, the estimated useful lives for property and equipment, fair value of warrants and stock options granted for services or compensation, respectively, estimates of the probability and potential magnitude of contingent liabilities, and the valuation allowance for deferred tax assets due to continuing and expected future operating losses.

 

Making estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set of circumstances that existed at the date of the consolidated financial statements, which management considered in formulating its estimate could change in the near term due to one or more future confirming events. Accordingly, actual results could differ from those estimates.

 

Accounts Receivable and Allowance for Doubtful Accounts

 

Accounts receivable were reported at realizable value, net of allowances for doubtful accounts, which were estimated and recorded in the period the related revenue was recorded. The Company estimated and reviewed the collectability of its receivables based on a number of factors, including the period they were outstanding. Historical collection and payer reimbursement experience was an integral part of the estimation process related to allowances for doubtful accounts associated with Adeona Clinical Laboratory. In addition, the Company regularly assessed the state of its billing operations in order to identify issues, which impacted the collectability of these receivables or reserve estimates. Revisions to the allowances for doubtful accounts estimates were recorded as an adjustment to bad debt expense. Receivables deemed uncollectible were charged against the allowance for doubtful accounts.

 

Revenue Recognition

 

The Company records revenue when all of the following have occurred: (1) persuasive evidence of an arrangement exists, (2) the service is completed without further obligation, (3) the sales price to the customer is fixed or determinable, and (4) collectability is reasonably assured.  The Company recognizes milestone payments or upfront payments that have no contingencies as revenue when payment is received.  For the year ended December 31, 2012 and 2011, the Company’s only stream of revenue was laboratory revenue.  Laboratory revenues are a component of discontinued operations for the years ended December 31, 2012 and 2011. See Note 3 – Discontinued Operations of Adeona Clinical Laboratory.

 

41
 

 

License Revenues

 

The Company’s licensing agreements may contain multiple elements, such as non-refundable up-front fees, payments related to the achievement of particular milestones and royalties. Fees associated with substantive at risk performance-based milestones are recognized as revenue upon completion of the scientific or regulatory event specified in the agreement. When the Company has substantive continuing performance obligations under an arrangement, revenue is recognized over the performance period of the obligations using a time-based proportional performance approach. Under the time-based method, revenue is recognized over the arrangement’s estimated performance period based on the elapsed time compared to the total estimated performance period. Revenue recognized at any point in time is limited to the amount of non-contingent payments received or due. When the Company has no substantive continuing performance obligations under an arrangement, it recognizes revenue as the related fees become due.

 

Revenues from royalties on third-party sales of licensed technologies are generally recognized in accordance with the contract terms when the royalties can be reliably determined and collectibility is reasonably assured. To date, the Company has not received any royalty revenues.

 

In 2010, the Company entered into the Meda Agreement for the development and commercialization of Effirma (oral flupirtine) for fibromyalgia.  As consideration for the sublicense, the Company received an up-front payment of $2.5 million upon execution of the Meda Agreement. This payment was recorded as license revenue in 2010. Pursuant to the Company’s license agreement with McLean Hospital, the Company paid 15% of the $2.5 million payment ($375,000), that was netted against the revenues received from Meda AB. The Company is also entitled to additional milestone payments of $5 million upon filing of an NDA with the U.S. FDA for oral flupirtine for fibromyalgia and $10 million upon marketing approval. The Meda Agreement also provides that the Company is entitled to receive net royalties of 7% of net sales of oral flupirtine approved for the treatment of fibromyalgia covered by issued patent claims in the U.S. and Japan. The Meda Agreement provides that Meda AB will assume all future development costs for the commercialization of oral flupirtine for fibromyalgia. Pursuant to the terms of the Company’s agreement with McLean Hospital, the Company is obligated to pay half of all future royalties the Company receives.  Future milestone payments will be recorded as revenue when payment is received as there are no future deliverables, and it is non-refundable.

 

Laboratory Revenues

 

The Company primarily recognized revenue for services rendered upon completion of the testing process. Billing for services reimbursed by third-party payers, including Medicare and Medicaid, were recorded as revenues, net of allowances for differences between amounts billed and the estimated receipts from such payers.

 

The Company maintained a sales allowance to compensate for the difference in its billing practices and insurance company reimbursements. In determining this allowance, the Company looked at several factors, the most significant of which was the average difference between the amount charged and the amount reimbursed by insurance carriers over the prior 12 months, otherwise known as the yearly average adjustment amount. The allowance taken was the averaged yearly average adjustment amount for these prior period multiplied by the period’s actual gross sales to determine the actual sales allowance for each period. See Note 3 - Discontinued Operations of Adeona Clinical Laboratory.

 

Risks and Uncertainties

 

The Company's operations could be subject to significant risks and uncertainties including financial, operational and regulatory risks and the potential risk of business failure. The global economic crisis has caused a general tightening in the credit markets, lower levels of liquidity, increases in the rates of default and bankruptcy, and extreme volatility in credit, equity and fixed income markets. These conditions may not only limit our access to capital, but also make it difficult for our customers, our vendors and us to accurately forecast and plan future business activities.

 

Cash and Cash Equivalents

 

Cash and cash equivalents include cash and highly liquid short-term investments with original maturities of three months or less.

 

Classification of Marketable Securities as Held to Maturity, Trading, and Available for Sale

 

The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and reevaluates such determinations at each balance sheet date. Debt securities are classified as held to maturity when the Company has the positive intent and ability to hold the securities to maturity. Debt securities for which the Company does not have the intent or ability to hold to maturity are classified as available for sale. Held to maturity securities are recorded as either short-term or long-term on the balance sheet, based on contractual maturity date and are stated at amortized cost. Marketable securities that are bought and held principally for the purpose of selling them in the near term are classified as trading securities and are reported at fair value, with unrealized gains and losses recognized in earnings. Debt and marketable equity securities not classified as held to maturity or as trading, are classified as available for sale, and are carried at fair market value, with the unrealized gains and losses, net of tax, included in the determination of comprehensive income and reported in shareholders’ equity. At December 31, 2012 and 2011, respectively, the Company had no debt and marketable equity securities.

 

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During the year ended December 31, 2011, the Company held investments in marketable securities that were classified as held to maturity and consisted of corporate bonds and certificates of deposits as follows (in thousands) :

 

   December 31, 2011 
Purchase of short-term investments  $(4,370)
Amortization of premium on investments   57 
Proceeds from short-term investments   4,293 
Loss on sale of short-term investments   20 
Fair value  $- 

 

Property and Equipment

 

Property and equipment is recorded at cost and depreciated or amortized using the straight-line method over the estimated useful life of the asset or the underlying lease term for leasehold improvements, whichever is shorter. The estimated useful life by asset description is noted in the following table.

 

Asset Description   Estimated Useful Life
Office equipment and furniture   3-5  years
Laboratory equipment   7-10 years
Manufacturing equipment   10 years
Leasehold improvements and fixtures   Lesser of estimated useful or life of lease

 

Depreciation expense was approximately $63,000 and $144,000 for the years ended December 31, 2012 and 2011, respectively. When assets are disposed of, the cost and accumulated depreciation are removed from the accounts. Repairs and maintenance are charged to expense as incurred.

 

During 2012, the Company reviewed property and equipment for impairment and determined that certain items were impaired due to obsolescence. As a result of this review, the Company recorded an impairment loss of approximately $47,000. For the year ended December 31, 2011, there were no significant events or changes in circumstances identified by the Company that would indicate that the carrying value of an asset was not recoverable.

 

Long-Lived Assets

 

The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such an event or change in circumstances occurs and potential impairment is indicated because the carrying values exceed the estimated future undiscounted cash flows of the asset, the Company will measure the impairment loss as the amount by which the carrying value of the asset exceeds its fair value.

 

Goodwill

 

Goodwill was not amortized, and was tested for impairment at the reporting unit level annually and in interim periods if certain events occur indicating that the carrying value of goodwill was impaired. A reporting unit was an operating segment for which discrete financial information was available and was regularly reviewed by management. The Company had one reporting unit, Adeona Clinical Laboratory, to which goodwill was assigned.

 

ASC No. 350, “Intangibles – Goodwill and Others,” requires a two-step approach to test goodwill for impairment for each reporting unit. The first step tests for impairment by applying fair value-based tests to a reporting unit. The second step, if deemed necessary, measures the impairment by applying fair value-based tests to specific assets and liabilities within the reporting unit. Application of the goodwill impairment tests require judgment, including identification of reporting units, assignment of assets and liabilities to each reporting unit, assignment of goodwill to each reporting unit, and determination of the fair value of each reporting unit. The determination of fair value for a reporting unit could be materially affected by changes in these estimates and assumptions.

 

At December 31, 2011, in connection with the Company classifying Adeona Clinical Laboratory as discontinued operations, previously recorded goodwill was considered impaired. See Note 3 – Discontinued Operations of Adeona Clinical Laboratory.

 

43
 

 

Derivative Liabilities

 

Once determined, derivative liabilities are adjusted to reflect fair value at each reporting period end, with any increase or decrease in the fair value being recorded in results of operations as an adjustment to fair value of derivatives. In addition, the fair value of freestanding derivative instruments such as warrants, are also valued using the Black-Scholes option pricing model.

 

Net Income (Loss) per Share

 

Net income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding. Diluted income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding including the effect of common share equivalents. All common equivalent shares were anti-dilutive, at December 31, 2012 and December 31, 2011, as such there is no separate computation for diluted loss per share. The number of options and warrants for the purchase of common stock, that were excluded from the computations of net loss per common share for the year ended December 31, 2012 were 4,453,746 and 1,632,501, respectively, and for the year ended December 31, 2011 were 2,979,010 and 3,259,186, respectively.

 

Research and Development Costs

 

The Company expenses research and development costs associated with developmental products not yet approved by the FDA to research and development expense as incurred. Research and development costs consist primarily of license fees (including upfront payments), milestone payments, manufacturing costs, salaries, stock-based compensation and related personnel costs, fees paid to consultants and outside service providers for laboratory development, legal expenses resulting from intellectual property prosecution and other expenses relating to the design, development, testing and enhancement of the Company’s product candidates.

 

Fair Value of Financial Instruments

 

The fair value accounting standards define fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is determined based upon assumptions that market participants would use in pricing an asset or liability. Fair value measurements are rated on a three-tier hierarchy as follows:

 

  · Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets;

 

  · Level 2 inputs: Inputs, other than quoted prices included in Level 1 that are observable either directly or indirectly; and

 

  · Level 3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions.

 

In many cases, a valuation technique used to measure fair value includes inputs from multiple levels of the fair value hierarchy described above. The lowest level of significant input determines the placement of the entire fair value measurement in the hierarchy.

 

The carrying amounts of the Company’s short-term financial instruments, including cash and cash equivalents, accounts receivable, other current assets, accounts payable and accrued liabilities, approximate fair value due to the relatively short period to maturity for these instruments.

 

Cash and cash equivalents include money market accounts and mutual funds of $8.6 million and $5.0 million as of December 31, 2012 and December 31, 2011, respectively, that are measured using Level 1 inputs. 

 

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Stock-Based Payment Arrangements

 

Generally, all forms of stock-based payments, including stock option grants, warrants, restricted stock grants and stock appreciation rights are measured at their fair value on the awards’ grant date typically using a Black-Scholes pricing model, based on the estimated number of awards that are ultimately expected to vest. Stock-based compensation awards issued to non-employees for services rendered are recorded at either the fair value of the services rendered or the fair value of the stock-based payment, whichever is more readily determinable and are re-measured over the corresponding vesting period. The expense resulting from stock-based payments is recorded in research and development expense or general and administrative expense in the consolidated statement of operations, depending on the nature of the services provided.

 

Income Taxes

 

The Company accounts for income taxes in accordance with accounting guidance now codified as FASB ASC Topic 740, “Income Taxes,” which requires that the Company recognize deferred tax liabilities and assets based on the differences between the financial statement carrying amounts and the tax bases of assets and liabilities, using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit (expense) results from the change in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all deferred tax assets will not be realized.

 

In addition, accounting guidance now codified as FASB ASC Topic 740-20, “Income Taxes – Intraperiod Tax Allocation” requires management to assess the need to accrue or disclose uncertain tax positions for proposed potential adjustments from various federal and state authorities who regularly audit the Company in the normal course of business. In making these assessments, management must often analyze complex tax laws of multiple jurisdictions. The accounting guidance prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company records the related interest expense and penalties, if any, as tax expense in the tax provision. At December 31, 2012 and 2011, respectively, the Company did not record any liabilities for uncertain tax positions.

 

Recent Accounting Pronouncements

 

There were no accounting standards or interpretations issued or recently adopted that are expected to have a material impact on the Company’s financial position, operations, or cash flows.

 

  3. Discontinued Operations of Adeona Clinical Laboratory and Note Receivable

 

On March 8, 2012, the Company sold all of its interest in Adeona Clinical Laboratory, LLC (the “Lab”) to Hartlab, LLC, an entity controlled by the Lab’s former owner. In connection with the sale of the Lab, the consideration received was (i) the immediate assignment of the Lab’s outstanding accounts receivable up through the date of closing, plus (ii) $700,000 payable pursuant to the terms of a two-year promissory note bearing interest at 5.7% per annum secured by all of the assets of the Lab. The note and all unpaid interest are due on March 1, 2014.

 

In accordance with ASC Topic 205-20 “Presentation of Financial Statements—Discontinued Operations” (ASC 205-20), the Company determined that all the criteria for reporting a discontinued operation had been met. Accordingly, the Lab has been classified as a discontinued operation and its results of operations, financial position and cash flows are separately reported for all periods presented. The assets of the discontinued operations are presented separately under the caption “Assets of discontinued operations” in the accompanying Consolidated Balance Sheets at December 31, 2012, and December 31, 2011, and consist of the following (in thousands):

 

   December 31, 
   2012   2011 
Assets of discontinued operations:        
Property and equipment, net  $-   $23 
Total assets  $-   $23 

 

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The summarized statement of operations data for Adeona Clinical Laboratory for the years ended December 31, 2012 and December 31, 2011 are as follows (in thousands):

 

   December 31, 
   2012   2011 
Laboratory fees, net  $115   $1,169 
           
Operating Costs and Expenses:          
General and administrative   466    539 
Cost of  laboratory services   110    975 
Impairment loss on goodwill   -    178 
Total operating costs and expenses   576    1,692 
Loss from discontinued operations   (461)   (523)
           
Other Income:          
Gain on sale of Adeona Clinical Laboratory   677    - 
Income (loss) from discontinued operations  $216   $(523)

 

  4. Selected Balance Sheet Information

 

Accounts receivable (in thousands)

 

   December 31, 
   2012   2011 
Accounts receivable  $682   $692 
Bad debt allowance - customer   (682)   (287)
Total  $-   $405 

 

Prepaid expenses and other current assets (in thousands)

   December 31, 
   2012   2011 
Intrexon prepaid research and development expenses - See Note 10  $2,412   $- 
Other receivables   17    - 
Prepaid expenses   80    16 
Total  $2,509   $16 

 

The Intrexon prepaid research and development expenses are classified as a current asset. The Company may terminate the arrangement at any time and receive a cash refund of the remaining balance minus any amounts owed to Intrexon. The Company anticipates that the majority of the prepaid will be applied to research and development goods and services during 2013.

 

Property and equipment (in thousands) 

   December 31, 
   2012   2011 
Manufacturing equipment  $297   $400 
Computer and office equipment   35    159 
Laboratory equipment   133    136 
    465    695 
Less accumulated depreciation   (242)   (372)
Total  $223   $323 

 

Accrued liabilities (in thousands) 

   December 31, 
   2012   2011 
Accrued vendor payments  $-   $1 
Compensation   -    28 
Total  $-   $29 

 

  5. Stock-Based Compensation

 

Stock Incentive Plan

 

During 2001, the Company’s Board of Directors and stockholders adopted the 2001 Stock Incentive Plan (the “2001 Stock Plan”). The total number of shares of stock with respect to which stock options and stock appreciation rights may be granted to any one employee of the Company or a subsidiary during any one-year period under the 2001 Stock Plan shall not exceed 250,000. All awards pursuant to the 2001 Stock Plan shall terminate upon the termination of the grantee’s employment for any reason. Awards include options, restricted shares, stock appreciation rights, performance shares and cash-based awards (the “Awards”). The 2001 Stock Plan contains certain anti-dilution provisions in the event of a stock split, stock dividend or other capital adjustment, as defined in the plan. The 2001 Stock Plan provides for a Committee of the Board to grant awards and to determine the exercise price, vesting term, expiration date and all other terms and conditions of the awards, including acceleration of the vesting of an award at any time. As of December 31, 2012, there were 1,066,007 options issued and outstanding under the 2001 Stock Plan.

 

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On March 20, 2007, the Company’s Board of Directors approved the 2007 Stock Incentive Plan (the “2007 Stock Plan”) for the issuance of up to 2,500,000 shares of common stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. This plan was approved by stockholders on November 2, 2007. The exercise price of stock options under the 2007 Stock Plan is determined by the compensation committee of the Board of Directors, and may be equal to or greater than the fair market value of the Company’s common stock on the date the option is granted. The total number of shares of stock with respect to which stock options and stock appreciation rights may be granted to any one employee of the Company or a subsidiary during any one-year period under the 2007 plan shall not exceed 250,000. Options become exercisable over various periods from the date of grant, and generally expire ten years after the grant date. As of December 31, 2012, there are 872,739 options issued and outstanding under the 2007 Stock Plan.

 

On November 2, 2010, the Board of Directors and stockholders adopted the 2010 Stock Incentive Plan (“2010 Stock Plan”) for the issuance of up to 3,000,000 shares of common stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. The exercise price of stock options under the 2010 Stock Plan is determined by the compensation committee of the Board of Directors, and may be equal to or greater than the fair market value of the Company’s common stock on the date the option is granted. Options become exercisable over various period from the date of grant, and generally expire ten years after the grant date. As of December 31, 2012, there are 2,515,000 options issued and outstanding under the 2010 Stock Plan.

 

In the event of an employee’s termination, the Company will cease to recognize compensation expense for that employee. There is no deferred compensation recorded upon initial grant date, instead, the fair value of the stock-based payment is recognized ratably over the stated vesting period.

 

The Company has applied fair value accounting for all share based payment awards since inception. The fair value of each option or warrant granted is estimated on the date of grant using the Black-Scholes option pricing model. The Black-Scholes assumptions used in the years ended December 31, 2012 and 2011 are as follows:

 

   Year ended December 31,
   2012  2011
Exercise price  $1.69 - $2.47  $0.49 - $2.22
Expected dividends  0%  0%
Expected volatility  108% - 174%  175% - 188%
Risk fee interest rate  0.37% - 1.98%  1.30% - 3.58%
Expected life of option  5 - 10 years  5 - 7 years
Expected forfeitures  0%  0%

 

The Company records stock-based compensation based upon the stated vested provisions in the related agreements. The vesting provisions for these agreements have various terms as follows:

 

  · immediate vesting,
  · half vesting immediately and the remainder over three years,
  · quarterly over three years,
  · annually over three years,
  · one-third immediate vesting and remaining annually over two years,
  · one half immediate vesting with remaining vesting over nine months,
  · one quarter immediate vesting with the remaining over three years
  · one quarter immediate vesting with the remaining over 33 months; and
  · monthly over three years.

 

During 2012, the Company granted 2,075,000 options to employees and consultants having an approximate fair value of $4.5 million based upon the Black-Scholes option pricing model.  During 2011, the Company granted 557,002 options to employees and consultants having an approximate fair value of $609,000 based upon the Black-Scholes option pricing model.

 

Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued employees for the years ended December 31, 2012 and 2011 were $1.4 million and $268,000, respectively. Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued to consultants for the years ended December 31, 2012 and 2011 were $216,000 and $705,000, respectively.

 

47
 

  

           Weighted     
           Average     
       Weighted   Remaining   Aggregate 
       Average Exercise   Contractual   Intrinsic 
   Options   Price   Life   Value 
Balance – December 31, 2010   2,539,091   $1.32    6.97 years   $1,028,000 
Granted   557,002   $1.26           
Exercised   (23,333)  $0.57           
Forfeited   (93,750)  $0.59           
Balance – December 31, 2011   2,979,010   $1.34    6.01 years   $- 
Granted   2,075,000   $2.21           
Exercised   (374,851)  $0.34           
Forfeited   (225,413)  $2.37           
Balance – December 31, 2012 – outstanding   4,453,746   $1.78    6.43 years   $1,308,000 
Balance – December 31, 2012 – exercisable   2,891,877   $1.60    5.71 years   $1,160,000 
                     
Grant date fair value of options granted – 2012       $4,467,984           
Weighted average grant date fair value – 2012       $2.15           
Grant date fair value of options granted – 2011       $609,000           
Weighted average grant date fair value – 2011       $1.09           

  

The options outstanding and exercisable at December 31, 2012 are as follows:

 

Options Outstanding  Options Exercisable
       Weighted   Weighted Average      Weighted   Weighted Average
Range of      Average   Remaining      Average   Remaining
Exercise Price  Options   Exercise Price   Contractual Life  Options   Exercise Price   Contractual Life
$0.09 - $2.00   2,162,362   $1.78   5.76 years   1,801,187   $1.14   5.52 years
$2.01 - $3.00   2,212,227    2.26   7.15 years   1,011,533    2.17   6.14 years
$3.01 - $6.00   79,157    4.87   4.49 years   79,157    4.87   4.49 years
$0.09 - $6.00   4,453,746   $1.78   6.43 years   2,891,877   $1.60   5.71 years

 

The options outstanding and exercisable at December 31, 2011 are as follows:

 

Options Outstanding  Options Exercisable
       Weighted   Weighted Average      Weighted   Weighted Average
Range of      Average   Remaining      Average   Remaining
Exercise Price  Options   Exercise Price   Contractual Life  Options   Exercise Price   Contractual Life
$0.09 - $4.57   2,889,011   $1.20   6.11 years   2,364,608   $1.29   5.72 years
$4.58 - $9.05   89,999    5.93   2.76 years   89,999    5.93   2.76 years
$0.09 - $9.05   2,979,010   $1.34   6.01 years   2,454,607   $1.46   5.62 years

 

The following is a summary of the Company’s non-vested stock options at December 31, 2012:

 

       Weighted Average 
   Unvested   Grant 
   Stock Options   Date Fair Value 
Non-vested – December 31, 2011   524,403   $0.82 
Granted   2,075,000    2.21 
Vested/Exercised   (891,332)   0.81 
Forfeited/Cancelled   (146,202)   1.79 
Non-vested – December 31, 2012   1,561,869   $2.11 
Weighted average remaining period for vesting   2.09 years      

 

As of December 31, 2012, total unrecognized stock-based compensation expense related to stock options was $3.2 million, which is expected to be expensed through September 2015.

 

FASB’s guidance for stock-based payments requires cash flows from excess tax benefits to be classified as a part of cash flows from financing activities.  Excess tax benefits are realized tax benefits from tax deductions for exercised options in excess of the deferred tax asset attributable to stock compensation costs for such options.  The Company did not record any excess tax benefits in 2012 or 2011.  Cash received from option exercises under the Company’s stock-based compensation plans for the years ended December 31, 2012 and 2011 was $127,000 and $15,000, respectively.

 

Stock Warrants and Derivative Liabilities

 

On October 25, 2012, the Company entered into a Common Stock Purchase Agreement with certain accredited investors. As part of this agreement, the Company issued warrants to purchase 635,855 shares of common stock to the placement agent, or its permitted assigns. The warrants have an exercise price of $1.60 and a life of five years. The warrants vested immediately and expire October 25, 2017. Since these warrants were granted as part of an equity raise, the Company has treated them as a direct offering cost. The result of the transaction has no affect to equity. As of December 31, 2012, all the warrants were outstanding.

 

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On March 15, 2012, the Company entered into a consulting agreement for a financial communications program, for a period of twelve months that began on February 20, 2012. As compensation for such program, the consultant is paid a monthly fee and will be issued a performance warrant exercisable for 250,000 shares of the Company’s common stock based on achievement of certain stock price milestones. Upon initiation of the program, 50,000 of the performance warrants vested. The performance warrant is exercisable for a period of two years from the date of issuance for an exercise price equal to the price ($2.20 per share) of the Company’s common stock on the date of execution (March 15, 2012). The expense recorded for the year ended December 31, 2012 approximated $63,000 and was estimated using the Monte Carlo valuation model. The assumptions used by the Company are summarized in the following table:

 

Exercise price  $2.20 
Expected dividends   0%
Expected volatility   110%
Risk free interest rate   0.26%
Expected life of warrant   2 years 

 

On December 20, 2011, the Company entered into a consulting agreement for financial advisory services, for a period of twelve months. As compensation for such services, the consultant is paid a monthly fee and on February 2, 2012, was issued a warrant exercisable for 100,000 shares of the Company’s common stock. The warrant is exercisable upon issuance for a period of five years from the date of issue at an exercise price equal to the price of the Company’s common stock on the date of issue. The fair value of the warrant approximated $200,000 and was measured using the Black-Scholes valuation model. All of this expense was recorded in the year ended December 31, 2012. The assumptions used by the Company are summarized in the following table:

 

Exercise price  $1.14 
Expected dividends   0%
Expected volatility   174%
Risk free interest rate   0.71%
Expected life of warrant   5 years 

 

On January 28, 2011, the Company entered into a Common Stock Purchase Agreement with three institutional investors. As part of this agreement, the Company issued warrants to purchase 1,428,572 shares of common stock. Each warrant was exercisable for thirteen months at $2.00 per share and subsequently exchanged for new warrants with substantially the same terms as the original warrants except that the expiration date was extended for two months. The original warrants had an anti-dilution price protection feature; if the Company issues securities at a price per share that is less than $2.00 per share, the warrant holders will be ratcheted down to the lower offering price. However, the Company had instituted a floor price of $1.40 per share in connection with the price protection.

 

On April 6, 2011, the Company entered into another Common Stock Purchase Agreement that triggered the ratchet provision and re-set the price of these warrants to $1.40 per share. Due to the re-set to the floor price, the warrant liability was marked-to-market and reclassified to additional paid-in capital since it ceased to contain the provisions of a derivative liability. As of December 31, 2012, all of these warrants have been exercised.

 

The warrants were initially recorded as liabilities at their estimated fair value on the commitment date, which was $716,000 with subsequent changes in estimated fair value recorded as a warrant expense in the Company’s statement of operations at each subsequent reporting period. On April 6, 2011, the fair value of the warrant liability was $1.5 million, which represented an increase in fair value of $765,000. The fair value was measured using the Black-Scholes valuation model. The assumptions used by the Company are summarized in the following table:

 

       Remeasurement 
   Commitment   Date 
   Date   April 6, 2011 
Closing stock price  $1.39   $2.08 
Expected dividend rate   0%   0%
Expected stock price volatility   117.1%   104.6%
Risk free interest rate   0.28%   0.29%
Expected life (years)   1.08    0.85 

 

On August 10, 2011, the Company entered into an agreement to exchange the warrants issued in connection with the January 28, 2011 financing for new warrants with substantially the same terms as the original warrants except that in the new warrants the expiration date was extended by two months.

 

On April 6, 2011, the Company entered into a Common Stock Purchase Agreement with an institutional investor. As part of this agreement, the Company issued a warrant to purchase 844,391 shares of common stock. The warrant was initially exercisable for thirteen months at $2.0725 per share. The warrant had an anti-dilution price protection feature; that provided if the Company issues securities at a price per share that is less than $2.0725 per share, the exercise price of the warrant will be ratcheted down to the lower offering price. On July 28, 2011, the warrant was exchanged for a new warrant with substantially similar terms except that in the new warrant (i) the anti-dilution price protection was eliminated, (ii) the exercise price was lowered to $1.00, (iii) the expiration date was extended for an additional three months to August 12, 2012, and (iv) the warrant’s initial exercise date was changed to January 2012. Due to this warrant exchange, the warrant liability was marked-to-market and reclassified to additional paid-in capital since it ceased to contain the provisions of a derivative liability. As of December 31, 2012, all of these warrants have been exercised.

 

The warrant is initially recorded as a liability at its estimated fair value on the commitment date, which was $776,000 with subsequent changes in estimated fair value recorded as a warrant expense in the Company’s statement of operations at each subsequent period. On July 28, 2011, the fair value of the warrant liability was $253,000, which represented a decrease in fair value of $523,000. The fair value is measured using the Black-Scholes valuation model. The assumptions used by the Company are summarized in the following table:

 

       Remeasurement 
   Commitment   Date 
   Date   July 28, 2011 
Closing stock price  $2.08   $0.84 
Expected dividend rate   0%   0%
Expected stock price volatility   112.1%   105.6%
Risk free interest rate   0.29%   0.21%
Expected life (years)   1.08    1.04 

 

The following table summarizes the estimated fair value of the warrant liabilities at December 31, 2011(in thousands):

 

Balance at December 31, 2010  $- 
Warrant liability   1,492 
Change in fair value of warrant liability   242 
Reclassification to additional paid-in capital   (1,734)
Balance at December 31, 2011  $- 

 

A summary of warrant activity for the Company for the year ended December 31, 2011 and for the year ended December 31, 2012 is as follows:

 

       Weighted Average 
   Number of Warrants   Exercise Price 
Balance at December 31, 2010   1,131,078   $3.49 
Granted   2,272,963    1.25 
Exercised   (15,615)   1.03 
Forfeited   (129,240)   2.08 
Balance as December 31, 2011   3,259,186    1.95 
Granted   985,855    1.71 
Exercised   (1,768,167)   1.11 
Forfeited   (844,373)   3.32 
Balance as December 31, 2012   1,632,501   $1.99 

 

Stock-based compensation expense included in general and administrative expenses relating to warrants issued to consultants for the year ended December 31, 2012 was $271,000. There was no stock-based compensation for warrants for the year ended December 31, 2011.

 

49
 

A summary of all outstanding and exercisable warrants as of December 31, 2012 is as follows:

 

Exercise
Price		     Warrants
Outstanding		     Warrants
Exercisable		     Weighted Average
Remaining
Contractual Life		     Aggregate
Intrinsic Value		  
$ 1.14       100,000       100,000       4.09 years     $ 62,000  
$ 1.32       18,182       18,182       3.00 years     $ 8,000  
$ 1.60       635,855       635,855       4.83 years     $ 102,000  
$ 2.20       250,000       50,000       1.20 years     $    
$ 2.22       517,257       517,257       3.91 years     $ -  
$ 3.30       61,207       61,207       3.30 years     $ -  
$ 3.75       50,000       50,000       3.13 years     $ -  
$ 1.99       1,632,501       1,432,501       3.80 years     $ 172,000  

   

Options of Subsidiary

 

As of December 31, 2012, Epitope, a majority-owned subsidiary of Synthetic Biologics, has 50,000 stock options outstanding and 40,000 stock options exercisable. These stock options have an exercise price of $0.001 and a remaining contractual life of 5.50 years.

 

6.Stockholders’ Equity

 

Year Ended December 31, 2011

 

During the year ended December 31, 2011, the Company issued 28,333 shares of common stock in connection with the exercise of stock options and warrants for proceeds of $15,000 and 10,615 shares of common stock related to a cashless exercise of warrants. The Company issued 73,585 shares of common stock for employment service, having a fair value of $94,000 ($1.29 average per share) and 171,796 shares of common stock for consulting services, having a fair value of $165,000 ($0.96 average per share), based on the quoted closing trading prices. The Company also issued 3,123,558 shares of common stock as consideration for the Exclusive Channel Collaboration Agreement with Intrexon, having a fair value of $1.7 million ($0.54 per share), based on the quoted closing trading price.

 

On January 28, 2011, the Company sold 2,857,144 shares of common stock and warrants exercisable for 1,428,572 shares of common stock for $4 million. Direct offering costs were approximately $296,000.

 

On April 6, 2011, the Company sold 1,688,782 shares of common stock and a warrant exercisable for 844,391 shares of common stock for $3.5 million. Direct offering costs were approximately $243,000.

 

Year Ended December 31, 2012

 

On October 31, 2012, the Company completed a private placement financing of 6,750,000 shares of the Company’s common stock at a closing price of $1.60 for gross proceeds of $10.8 million.  The Company paid direct offering costs of $680,000.  See Note 5 regarding warrants granted with this offering.

 

During the year ended December 31, 2012, the Company issued 374,851 shares of common stock, in connection with the exercise of stock options, for proceeds of approximately $127,000. The Company also issued 1,768,167 shares of common stock in connection with the exercise of warrants, for proceeds of approximately $2.0 million. The Company also issued 3,552,210 shares of common stock as consideration for a second Exclusive Channel Collaboration Agreement with Intrexon, having a fair value of $7.8 million ($2.20 per share), based on the quoted closing trading price. These shares are subject to the registration rights agreement as described in Note 7. In connection with the private placement that was completed on October 31, 2012, the Company also entered into an agreement with NRM VII Holdings I, LLC, an affiliate of Intrexon that acquired 3,125,000 shares of the Company’s common stock in the private placement, pursuant to which NRM VII Holdings I, LLC agreed to be bound by the terms of and join Intrexon as a party to its registration rights agreement as described in Note 7. In addition, the Company issued 625,000 shares of common stock as consideration for the acquisition of the C. diff program assets of Prev ABR LLC, having a fair value of $1.2 million ($1.87 per share), based on the quoted closing trading price.

 

7.License, Collaborative and Employment Agreements and Commitments

 

License and Collaborative Agreements

 

As described below, the Company has entered into several license and collaborative agreements for the right to use research, technology and patents. Some of these license and collaborative agreements may contain milestones.  The specific timing of such milestones cannot be predicted and are dependent on future developments as well as regulatory actions which cannot be predicted with certainty (including actions which may never occur).  Further, under the terms of certain licensing agreements, the Company may have the obligation to pay certain milestones contingent upon the achievement of specific levels of sales.  Due to the long-range nature of such commercial milestone amounts, they are neither probable at this time nor predictable and consequently are not included in this disclosure.

 

On December 19, 2012, the Company entered into a License Agreement with The University of Texas at Austin (the “University”) for the exclusive license of the right to use, develop, manufacture, market and commercialize certain research and patents related to pertussis antibodies. The License Agreement provides that the University is entitled to payment of past patent expenses, an annual payment of $50,000 per year commencing on the effective date through December 31, 2014 and a $25,000 payment on December 31, 2015 and milestone payments of $50,000 upon commencement of Phase I clinical trials, $100,000 upon commencement of Phase III clinical trials, $250,000 upon NDA submission in the U.S., $100,000 upon European Medicines Agency approval and $100,000 upon regulatory approval in an Asian country. In addition, the University is entitled to a running royalty upon net sales (as defined in the License Agreement). The License Agreement terminates upon the expiration of the patent rights (as defined in the License Agreement); provided, however that the License Agreement is subject to early termination by the Company in its discretion and by the University for a breach of the License Agreement by the Company.

 

In connection with the License Agreement, the Company and the University also entered into a Sponsored Research Agreement pursuant to which the University will perform certain research work related to pertussis. The Sponsored Research Agreement may be renewed annually, in the sole discretion of the Company, after the first year for two additional one year terms with a fixed fee for the first year of $303,287 and for the second and third years, if renewed, a fixed fee of $316,438 and $328,758 respectively, all payable in quarterly installments. If renewed by the Company after the first year for the remaining two years, the research shall be performed from the effective date of the Sponsored Research Agreement until December 31, 2015; provided, however, the Sponsored Research Agreement is subject to early termination upon the written agreement of the parties, a default in the material obligations under the Research Agreement which remain uncured for sixty days after receipt of notice, automatically upon the Company’s bankruptcy or insolvency and by the Company in its sole discretion at any time after the one year anniversary of the date of execution thereof upon no less than 90 days notice. Upon termination prior to December 31, 2014, the Company shall only be responsible for payment of expenses that do not exceed the fixed annual amount and are incurred prior to the termination date and non-cancellable expenses committed to be expended by the University prior to the termination date for the lesser of the remainder of their appointment in the case of salaries and December 31, 2014. Upon a termination after December 31, 2014 or due to a breach by the University, the Company shall only be responsible for all reasonable expenses that do not exceed the fixed annual amount and that are incurred by the University prior to the termination date for services performed prior to the termination date.

 

On November 28, 2012, a closing was held for the transaction contemplated by the Prev Agreement the Company entered into with Prev ABR LLC (“Prev”), pursuant to which it acquired the C. diff program assets of Prev, including pre-Investigational New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and pending U.S. and international patents.  Pursuant to the Prev Agreement, the Company paid Prev an initial cash payment of $100,000 upon execution of the Prev Agreement and at closing paid an additional cash payment of $135,000 and issued 625,000 unregistered shares of our common stock to Prev. See Note 6. In addition, upon the achievement of the milestones set forth below, Prev may be entitled to receive additional consideration payable 50% in cash and 50% in our stock, subject to Prev’s option to receive the entire payment in shares of our stock, with the exception of the first milestone payments to be paid in cash: (i) upon commencement of an IND; (ii) upon commencement of a Phase I clinical trial; (iii) upon commencement of a Phase II clinical trial; (iv) upon commencement of a Phase III clinical trial; (v) upon Biologic License Application (BLA) filing in the U.S. and for territories outside of the U.S. (as defined in the Prev Agreement); and (vi) upon BLA approval in the U.S. and upon approval in territories outside the-U.S. The Prev Agreement also provides that Prev has a right to the return to it of all assets acquired by the Company under the Prev Agreement if on or prior to the date that is (i) thirty (30) months after the execution of the Prev Agreement, the Company has not initiated toxicology studies in non-rodent models or (ii) thirty six (36) months have not filed an IND under the program related to the assets and such failure is not due to action or inaction of Prev or breach of its representations or warranties or covenants or if there is a change of control as defined in the Prev Agreement and after such change of control the assets are not further developed; provided however that such thirty (30) and thirty six (36) month periods can be extended by the Company for an additional twelve (12) months upon payment of a cash milestone payment.

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On August 6, 2012, the Company expanded its relationship with Intrexon and entered into the Second Channel Agreement with Intrexon that governs an “exclusive channel collaboration” arrangement in which the Company will use Intrexon’s technology relating to the identification, design and production of human antibodies and DNA vectors for the development and commercialization of a series of monoclonal antibody therapies for the treatment of certain serious infectious diseases. Pursuant to the terms of the Second Stock Issuance Agreement with Intrexon, which was approved by the Company’s stockholders on October 5, 2012, the Company issued 3,552,210 shares of its common stock, $0.001 par value, which issuance is also deemed paid in consideration for the execution and delivery of the Second Channel Agreement, dated August 6, 2012, between the Company and Intrexon. The fair value of this transaction was $7.8 million and was charged to research and development expense for the year ended December 31, 2012, in accordance with the Company’s accounting policy. In connection with the transactions contemplated by the Second Stock Issuance Agreement, and pursuant to the First Amendment to Registration Rights Agreement (the “First Amendment to Registration Rights Agreement”) executed and delivered by the parties at the closing, the Company agreed to file a “resale” registration statement registering the resale of certain of the shares issued under the Second Stock Issuance Agreement. None of the shares to be issued under the Second Stock Issuance Agreement need to be registered until April 30, 2013. Under that agreement, the Company is obligated to use its reasonable best efforts to cause the “resale” registration statement to be declared effective as promptly as practicable after filing and to maintain the effectiveness of the registration statement until all securities therein are sold or are otherwise can be sold pursuant to Rule 144, without any restrictions.

 

Subject to certain expense allocations and other offsets provided in the Second Channel Agreement, the Company will pay Intrexon royalties on annual net sales of the Synthetic Products, calculated on a Synthetic Product-by-Synthetic Product basis. The Company has likewise agreed to pay Intrexon a percentage of quarterly revenue obtained from a sublicensor in the event of a sublicensing arrangement.

 

The Company also agreed upon the filing of an Investigational New Drug application with the U.S. Food and Drug Administration for a Synthetic Product, or alternatively the filing of the first equivalent regulatory filing with a foreign regulatory agency (both as applicable, the “IND Milestone Event”), to pay Intrexon either (i) two million dollars ($2M) in cash, or (ii) that number of shares of Common Stock (the “IND Milestone Shares”) having a fair market value equaling two million dollars ($2M) where such fair market value is determined using published market data of the share price for Common Stock at the close of market on the business day immediately preceding the date of public announcement of attainment of the IND Milestone Event.

 

Upon the first to occur of either first commercial sale of a Synthetic Product in a country or the granting of the regulatory approval of that Synthetic Product (both as applicable, the “Approval Milestone Event”), the Company agreed to pay to Intrexon either (i) three million dollars ($3M) in cash, or (ii) that number of shares of Common Stock (the “Approval Milestone Shares”) having a fair market value equaling three million dollars ($3M) where such fair market value is determined using published market data of the share price for Common Stock at the close of market on the business day immediately preceding the date of public announcement of attainment of the Approval Milestone Event.

 

The Company also agreed that it will pay an optional and varying fee whereby the Company remits a payment, in cash or equity at our sole discretion, to Intrexon calculated as a multiple of the number of targets in excess of three (3) total that the Company desires to elect (the “Field Expansion Fee”). The Field Expansion Fee must be paid completely in either Common Stock or cash, and will comprise either (i) two million dollars ($2M) in cash for each target in excess of three (3) total that the Company elects, or (ii) that number of shares of Common Stock (the “Field Expansion Fee Shares”) having a fair market value equaling two million dollars ($2M) for each such target that the Company elects in excess of three where such fair market value is determined using published market data establishing the volume-weighted average price for a share of Common Stock over the thirty (30) day period immediately preceding the date of the Field Expansion Fee Closing.

 

On November 18, 2011, the Company entered into the Initial Channel Agreement with Intrexon that governs an “exclusive channel collaboration” arrangement in which the Company initially intended to use Intrexon’s technology directed towards the production of PGIS. As consideration for execution of the Initial Channel Agreement, the Company entered into the Initial Stock Purchase Agreement with Intrexon pursuant to which the Company issued to Intrexon a number of shares of our common stock equal to 9.995% of the number of shares of the Company’s common stock issued and outstanding following and giving effect to such issuance at a purchase price equal to the $0.001 par value of such shares, which issuance was deemed paid in consideration for the execution and delivery of the Initial Channel Agreement. The Company also agreed to issue additional shares of its common stock to Intrexon upon dosing of the first patient in a Phase II clinical trial sponsored by the Company in the U.S., or similar study as the parties may agree in a country other than the U.S. The program under this Initial Channel Agreement is in the discovery stage. In connection with the transactions contemplated by the Stock Purchase Agreement, and pursuant to the Registration Rights Agreement executed and delivered by the Company to Intrexon, the Company agreed to file a “resale” registration statement registering the resale of the First Tranche Shares within 120 days of the closing date of such issuance. The registration statement registering such shares was declared effective on April 13, 2012, but is not currently valid due to certain issues regarding the failure of the Company’s prior auditor to follow proper partner rotation. Intrexon has agreed not to require the Company to file a post effective registration statement on Form S-1 with respect to the First Tranche Shares and instead has agreed to wait until the Company is once again S-3 eligible for registration of such shares.

 

The Company paid Intrexon a prepayment of research and development expenses of $2.5 million for research and development goods and services to be provided in the future and has been recorded on the Company’s balance sheet in prepaid expenses and other current assets.

  

In September of 2005, the Company entered into a three-year research agreement with the University of Michigan. Pursuant to that agreement, the Company sponsored research of approximately $460,000 per year.  On March 20, 2008, the Company terminated the agreement.  On March 24, 2009, the Company entered into a payment plan with the University of Michigan to pay the outstanding balance of $197,000.  The Company agreed to pay $5,000 per month, the balance was paid in full July 2012.

 

Employment Agreements

 

Effective February 3, 2012, Dr. Kuo resigned from his positions as President and Chief Executive Officer. In connection with his resignation, Dr. Kuo entered into a nine-month consulting agreement with the Company (the “Consulting Agreement”). Pursuant to the Consulting Agreement, Dr. Kuo will be entitled to a consulting fee of $17,000 per month and retain the right to exercise the stock options held by him that have vested (324,999) as of the effective date of the Consulting Agreement for a period expiring on the date that is one year from the effective date of the Consulting Agreement.

 

Effective February 3, 2012, Jeffrey Riley was appointed to serve as the Company’s Chief Executive Officer and President. In connection with his appointment, Mr. Riley entered into a three-year employment agreement with the Company (the “Riley Employment Agreement”). Pursuant to the Riley Employment Agreement, Mr. Riley will be entitled to an annual base salary of $348,000 and will be eligible for discretionary performance and transactional bonus payments. Additionally, Mr. Riley was granted options to purchase 750,000 shares of the Company’s common stock with an exercise price equal to the per share market price on the date of issue. These options will vest pro rata, on a monthly basis, over thirty-six months. The Company measured the fair value of the stock options at approximately $1.7 million using a Black-Scholes valuation model.

 

Effective February 6, 2012, C. Evan Ballantyne was appointed the Company’s Chief Financial Officer. In connection with his appointment, Mr. Ballantyne entered into a three-year employment agreement with the Company (the “Ballantyne Employment Agreement”). Pursuant to the Ballantyne Employment Agreement, Mr. Ballantyne will be entitled to an annual base salary of $298,000 and will be eligible for discretionary performance and transactional bonus payments. Additionally, Mr. Ballantyne was granted options to purchase 425,000 shares of our common stock with an exercise price equal to our per share market price on the date of issue. These options will vest pro rata, on a monthly basis, over thirty-six months. The Company measured the fair value of the stock options at approximately $1 million using a Black-Scholes valuation model.

 

Other Commitments

 

As of December 31, 2012, amounts due for license and sponsored research agreements are as follows (in thousands):

 

Year Ending December 31,     
2013  $287 
2014   60 
2015   35 
2016   10 
2017   10 
Total  $402 

  

Operating Lease

 

During 2012, the Company entered into a one year operating lease for office space in Ann Arbor, Michigan.  In March 2013, this lease was amended to extend the term of the lease to December 31, 2014, for annual lease payments of $33,000. In March 2012, the Company also entered into a one year operating lease that may be renewed for two additional terms of one year, for office space in Rockville, Maryland, for annual lease payments of $35,000. The Maryland office lease may be terminated with 60 days written notice.

 

During the years ended December 31, 2012 and 2011, the Company recognized rent expense of $123,000 and $64,000, respectively.

 

51
 

 

8.Stock Repurchase Program

 

On April 3, 2009, the Company’s Board of Directors approved a Stock Repurchase Program authorizing the Company to repurchase, from time-to-time and through December 31, 2009, up to $1 million of its common stock, up to a maximum of four million shares at prices of up to $5 per share. As of December 31, 2012, the Company had repurchased 81,482 shares for approximately $50,000 ($0.61 per share), based upon the quoted closing trading price.  These treasury shares are not included in the computation of earnings (loss) per share and are deemed to be canceled and retired.

 

9.Income Taxes

 

There was no income tax expense for the years ended December 31, 2012 and 2011 due to the Company’s net losses.

 

The Company’s tax expense differs from the “expected” tax expense for the years ended December 31, 2012 (computed by applying the Federal Corporate tax rate of 34% to loss before taxes and 3.96% for Michigan State Corporate taxes, the blended rate used was 37.96%) and December 31, 2011, (computed by applying the Federal Corporate tax rate of 32.13% to loss before taxes and 5.5% for Michigan State Corporate taxes, the blended rate used was 37.63%), as follows (in thousands):

 

    2012     2011  
Computed “expected” tax benefit - Federal   $ (5,803 )   $ (2,618 )
Computed “expected” tax benefit - State     (676 )     (448 )
Meals, entertainment and other     5     5  
Non-deductible stock-based compensation     518       366  
Warrant expense     -       562  
Change in fair value of warrant expense     -       91  
Realized loss on debt securities     -       7  
Change in valuation allowance     5,956       2,035  
    $ -     $ -  

 

The effects of temporary differences that gave rise to significant portions of deferred tax assets at December 31, 2012 and 2011 are as follows (in thousands):

 

Deferred tax assets:   2012     2011  
Stock issued for services   $ 318   $ 321
Bad debt – change in allowance     1,099     205
Stock issued for acquisition of program     527     -  
Net operating loss carry-forward     14,964     10,425
Total gross deferred tax assets     16,908     10,951
Less valuation allowance     (16,908 )     (10,951 )
Net deferred tax assets   $    -     $ -  

 

At December 31, 2012, the Company has a net operating loss carry-forward of approximately $39.7 million available to offset future taxable income expiring through 2032. However, utilization of these net operating losses may be limited due to potential ownership changes under Section 382 of the Internal Revenue Code.

 

The valuation allowance at December 31, 2011 was approximately $11.0 million. The net change in valuation allowance during the year ended December 31, 2012 was an increase of approximately $6.0 million. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The ultimate realization of deferred income tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred income tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. Based on consideration of these items, management has determined that enough uncertainty exists relative to the realization of the deferred income tax asset balances to warrant the application of a full valuation allowance as of December 31, 2012.

 

ASC 740-10 “Accounting for Uncertain Tax Positions” prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return and also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition.

 

As of December 31, 2012 and 2011, the Company had no unrecognized tax benefits and no adjustments to liabilities or operations were required under ASC 740-10. The Company’s practice was and continues to be to recognize interest and penalty expenses related to uncertain tax positions in income tax expense, which was zero for the years ended December 31, 2012 and 2011. The Company files United States federal and various state income tax returns.

 

The Company is routinely subject to examinations by taxing authorities in these various jurisdictions. The Company’s U.S. tax matters for the years 2000 through 2012 remain subject to examination by the Internal Revenue Service due to the Company’s NOL carryforwards. The Company’s U. S. tax matters remain subject to examination by various state and local tax jurisdictions due to our NOL carryforwards.

 

The Company does not anticipate that it is reasonably possible that unrecognized tax benefits as of December 31, 2012 will significantly change within the next 12 months.

 

10. Related Party Transactions

 

In February 2012, the Company entered into a consulting agreement with Dr. James Kuo, a director of the Company.

 

From January 2, 2012 through September 30, 2012, Steve H. Kanzer was engaged as the Company’s Interim Director of its Biologics Division. In connection with his appointment, Mr. Kanzer entered into a six month employment agreement with us on a full time basis (the “Kanzer Employment Agreement”), which may be extended for an additional three (3) months upon consent of the parties. Pursuant to the Kanzer Employment Agreement, Mr. Kanzer will be entitled to a base salary of $90,000 for the term, healthcare coverage pursuant to the Company’s healthcare insurance plan, reimbursement for certain relocation expenses and rent expense. The Kanzer Employment Agreement also includes confidentiality obligations and inventions assignments by Mr. Kanzer.  Mr. Kanzer is not entitled to severance pay upon termination of his employment. On October 1, 2012, the Kanzer Employment Agreement was amended (the “Amended Kanzer Employment Agreement”) and Mr. Kanzer is engaged as the Company Licensing Associate. In connection with this appointment, Mr. Kanzer entered into a two year agreement with us on a part time basis (2.5 days per week). Pursuant to the Amended Kanzer Employment Agreement, Mr. Kanzer will be entitled to a base salary of $150,000 for the term and healthcare coverage pursuant to the Company’s healthcare insurance plans.

 

In August 2012, the Company entered into an Exclusive Channel Agreement with Intrexon and issued 3,552,210 shares of common stock as consideration, having a fair value of $7.8 million ($2.20 per share), based on the quoted closing trading price on October 5, 2012. In November 2011, the Company entered into an Exclusive Channel Agreement with Intrexon and issued 3,123,558 shares of common stock as consideration, having a fair value of $1.7 million ($0.54 per share), based on the quoted closing trading price. In connection with the November 2011 and August 2012 Exclusive Channel Agreements, the Company paid Intrexon approximately $2.9 million during 2012, including a prepayment of research and development expenses of $2.5 million for research and development goods and services to be provided in the future which has been recorded on the Company’s balance sheet in prepaid expense as described in Note 4. In October 2012, the Company consummated the Company’s October 2012 Private Placement and entered into a stock purchase agreement with several investors, including NRM VII Holdings I, LLC, an entity affiliated with Intrexon. Randal J. Kirk, directly and through certain affiliates, has voting and dispositive power over a majority of the outstanding capital of Intrexon Corporation, and controls NRM VII Holdings I, LLC. Mr. Kirk disclaims beneficial ownership of the shares held by Intrexon Corporation and NRM VII Holdings I, LLC, except to the extent of any pecuniary interest therein.

   

52
 

 

Item 9.     Changes In and Discussions with Accountants on Accounting and Financial Disclosures

 

On May 1, 2012, the Company was informed by Berman & Company, P.A. (“Berman & Company”), its independent registered accounting firm at that time, that during a regular Public Company Accounting Oversight Board (“PCAOB”) inspection of Berman & Company, the PCAOB issued a comment that the audit opinion included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2011 was issued by a partner at Berman & Company who was not authorized under the PCAOB rules to issue the opinion or act as the Company’s named engagement partner with respect to the Form 10-K audit (or prior 2011 Form 10-Q interim reviews) after the original engagement partner rotated off the account under the Securities and Exchange Commission’s independence rules as it pertains to partner rotation (S-X Rule 2-01 - Qualifications of Accountants).

 

Item 9A.   Controls and Procedures

 

Disclosure Controls and Procedures

 

The Company has adopted and maintains disclosure controls and procedures that are designed to provide reasonable assurance that information required to be disclosed in the reports filed under the Exchange Act, such as this Form 10-K, is collected, recorded, processed, summarized and reported within the time periods specified in the rules of the SEC. The Company’s disclosure controls and procedures are also designed to ensure that such information is accumulated and communicated to management to allow timely decisions regarding required disclosure. As required under Exchange Act Rule 13a-15, the Company’s management, including the Chief Executive Officer and Chief Financial Officer, has conducted an evaluation of the effectiveness of disclosure controls and procedures as of the end of the period covered by this Annual Report on Form 10-K. Based upon that evaluation, the Company’s Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures are effective to ensure that information required to be disclosed by the Company in the reports that the Company files or submits under the Exchange Act, is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the Company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. 

 

Management’s Report on Internal Control Over Financial Reporting

 

The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rule 13a-15. The Company’s internal control over financial reporting is designed to provide reasonable assurance to the Company’s management and Board of Directors regarding the preparation and fair presentation of published financial statements.  Management conducted an assessment of the Company’s internal control over financial reporting based on the framework and criteria established by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework.  Based on the assessment, management concluded that, as of December 31, 2012, the Company’s internal control over financial reporting is effective based on those criteria.

 

The Company’s management, including its Chief Executive Officer and Chief Financial Officer, does not expect that the Company’s disclosure controls and procedures and its internal control processes will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of error or fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that the breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and may not be detected. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.

 

Changes in Internal Control

 

There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that occurred during our fiscal quarter ended December 31, 2012 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

This Annual Report on Form 10-K does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting.  Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to rules of the SEC that permit the Company to provide only management’s report in this Annual Report on Form 10-K.

 

Item 9B.          Other Information

 

None.

 

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PART III

 

Item 10.           Directors, Executive Officers and Corporate Governance

 

Below is certain information regarding our directors and executive officers.

 

Name   Age   Position
Jeffrey Riley   50   Chief Executive Officer, President and Director
C. Evan Ballantyne   53   Chief Financial Officer
Jeffrey J. Kraws     48   Chairman
Steve H. Kanzer,  C.P.A, J.D.   49   Director
Scott L. Tarriff   53   Director
Jeffrey Wolf,  J.D.   49   Director

  

Jeffrey Riley. Mr. Riley, a member of the Synthetic Biologics’ Board of Directors since March 2010 and Chairman of the Board from November 2011 to May 2012, was appointed as the Company’s President and Chief Executive Officer in February 2012. Since November 2009 until January 2012, Mr. Riley served as the Managing Director of 526 Ventures, a life science-focused consulting firm with a commercial and transactional focus, and from April 2009 until February 2012 he was the business officer of Ruga Corporation, a Stanford University spin-out oncology drug discovery company focused on targeting tumor adaptive responses. From January 2005 until January 2010, Mr. Riley was a member of the advisory board and a venture partner of Queensland Biocapital Fund, an Australia-based venture fund. Mr. Riley has held senior corporate and commercial development positions with multiple venture-backed biotech companies. In these positions, he was responsible for raising equity and negotiating alliances including in-licensing, out-licensing, distribution agreements, technology acquisitions and research agreements with large pharmaceutical companies and government agencies. Mr. Riley's pharmaceutical experience includes commercial management and mergers and acquisition roles for Pfizer and SmithKline Beecham. Additionally, Mr. Riley served as CFO and VP Corporate Development for Nichols Institute Diagnostics, later acquired by Corning and spun out as Quest Diagnostics. Mr. Riley’s education includes: a B.S. degree from Boise State University, coursework at UCSF/Berkeley in drug discovery/development and participation in a dual-degree graduate program, an M.B.A./M.I.M. sponsored by Arizona State University and the Thunderbird School of Global Management.

 

Mr. Riley brings to the Board extensive knowledge of the pharmaceutical industry. Having served in senior corporate positions in biotech and pharmaceutical companies he has a vast knowledge of the industry.  His business experience provides him with a broad understanding of the operational, financial and strategic issues facing public companies.

 

C. Evan Ballantyne. Mr. Ballantyne joined Synthetic Biologics as its Chief Financial Officer in February 2012. He also serves as the Company's Corporate Secretary and Treasurer. From 2006 until its acquisition in April 2011, Mr. Ballantyne served as Executive Vice President and Chief Financial Officer of Clinical Data, Inc., a publicly-traded biopharmaceutical company which was acquired by Forest Laboratories, Inc. for $1.3 billion. While at Clinical Data, he was instrumental in leading corporate financings totaling approximately $220 million as well as a number of acquisition and divestitures totaling $116 million. Mr. Ballantyne has also served as Chief Financial Officer of a number of private medical technology companies, including Avedro and ZymeQuest. Earlier in his career, he served as Vice President and Chief Operating Officer for ACNielsen Europe Middle East & Africa and held the Chief Financial Officer position as well for two years. There, Mr. Ballantyne was responsible for all aspects of operations, strategic planning and finance in more than 45 countries for a corporation with 9,700 employees. He also helped lead the company's successful ISO certification process. He began his career at the Dun & Bradstreet Corporation where he held several senior financial positions. Mr. Ballantyne earned a BA from the University of Western Ontario, and took a post-graduate degree in Business Administration with Honors from the University of Windsor.

 

Jeffrey J. Kraws. Mr. Kraws has been a director since January of 2006, and was appointed independent, non-executive Chairman of the Board in May 2012. Since 2003, Mr. Kraws has served Chief Executive Officer and co-founder of Crystal Research Associates, and since February 2012, he has served as partner and co-founder of TopHat Capital, LLC. Well known and respected on Wall Street, Mr. Kraws has received some of the most prestigious awards in the industry. Among other awards, he was given a “5-Star Rating” in 2001 by Zacks and was ranked the number one analyst among all pharmaceutical analysts for stock performance in 2001 by Starmine.com. Prior to founding Crystal Research Associates, Mr. Kraws served as co-president of The Investor Relations Group (IRG), a firm representing primarily under-followed, small-capitalization companies. Previously, Mr. Kraws served as a managing director of healthcare research for Ryan Beck & Co. and as director of research/senior pharmaceutical analyst and managing director at Gruntal & Co., LLC (prior to its merger with Ryan Beck & Company). Mr. Kraws served as managing director of the healthcare research group and senior pharmaceutical analyst at First Union Securities (formerly EVEREN Securities); as senior U.S. pharmaceutical analyst for the Swedish-Swiss conglomerate Asea Brown Boveri; and as managing director and president of the Brokerage/Investment Banking operation of ABB Aros Securities, Inc. He also served as senior pharmaceutical analyst at Nationsbanc Montgomery Securities, BT Alex Brown & Sons, and Buckingham Research. Mr. Kraws also has industry experience, having been responsible for competitive analysis within the treasury group at Bristol-Myers-Squibb Company. He holds an M.B.A. from Cornell University and a B.S. degree from State University of New York-Buffalo. During 2006 through February of 2007, Mr. Kraws served as our Vice President of Business Development, on a part-time basis.

 

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Mr. Kraws brings a strong business background to Synthetic Biologics, having worked as a pharmaceutical analyst for over 22 years. Mr. Kraws brings to the Board significant strategic, business and financial experience related to the business and financial issues facing pharmaceutical companies. Mr. Kraws has a broad understanding of the operational, financial and strategic issues facing pharmaceutical companies. Through his services as the Company’s Vice President of Business Development during 2006 and a part of 2007, he developed extensive knowledge of Synthetic Biologics’ business.

  

Steve H. Kanzer, C.P.A, J.D. Mr. Kanzer is a co-founder and served as our President from our inception in February of 2001 until May of 2006. Since October 2012, Mr. Kanzer has served as our Licensing Associate, and from January 2012 through September 2012, he served as our Interim Director of our Biologics Division. Mr. Kanzer previously served as our Chief Executive Officer from September of 2004 until November of 2008, Chairman of the Board until February 6, 2010 and currently serves as a director. Mr. Kanzer has also been a director and officer of our subsidiaries, including Solovax, Inc., Effective Pharmaceuticals, Inc., Putney Drug Corp., Epitope Pharmaceuticals, Inc. and CD4 Biosciences, Inc. Since December 2000, he has served as co-founder and Chairman of Accredited Ventures Inc. and Accredited Equities Inc., a venture capital firm and investment bank, respectively, which both specialize in the biotechnology industry. Prior to founding Accredited Ventures and Accredited Equities in December 2000, Mr. Kanzer served as Senior Managing Director-Head of Venture Capital at Paramount Capital from 1991 until December of 2000. While at Paramount Capital, Mr. Kanzer was involved in the formation and financing of a number of biotechnology companies and held various positions in these companies. Prior to joining Paramount Capital in 1992, Mr. Kanzer was an attorney at the law firm of Skadden, Arps, Slate, Meagher & Flom in New York where he specialized in mergers and acquisitions. Mr. Kanzer received a J.D. from New York University School of Law in 1988 and a B.B.A. in Accounting from Baruch College in 1985, where he was a Baruch Scholar. Mr. Kanzer is active in university-based pharmaceutical technology licensing and has served as Co-Chair of the New York Chapter of the Licensing Executives Society.

 

Mr. Kanzer has been associated with the Company since inception, and initiated and negotiated our synthetic biology collaborations with Intrexon and brings to the Board extensive knowledge about our business operations and in particular our licenses and products. Mr. Kanzer also brings to the Board significant executive leadership and operational experience. Mr. Kanzer’s legal background provides him with a broad understanding of the legal issues facing Synthetic Biologics, the financial markets and the financing opportunities available to Synthetic Biologics.

  

Scott L. Tarriff. Mr. Tarriff has been a director since February 3, 2012. Since January 2007 he has served as a director and Chief Executive Officer of Eagle Pharmaceuticals, Inc., a hospital specialty company. Eagle Pharmaceuticals, Inc. is focused on developing branded parenteral products through the application of various in-licensed drug delivery technologies. Prior to forming Eagle Pharmaceuticals, Inc., Mr. Tarriff was president and chief executive officer of Par Pharmaceutical Companies, Inc. Mr. Tarriff joined Par Pharmaceutical Companies, Inc., in 1998 as executive vice president. Mr. Tarriff was named president and Chief Executive Officer of Par Pharmaceutical, Inc., the company’s principal operating subsidiary, in 2001, and was elected to the company’s Board of Directors in 2002. In September 2003, he was appointed President and Chief Executive Officer of Par Pharmaceutical Companies, Inc. Mr. Tarriff joined Par Pharmaceutical Companies, Inc. following a 12-year career at Bristol-Meyers Squibb. From 2009 until 2011, Mr. Tarriff served as a director of Clinical Data, Inc. He received his M.B.A. from Rider College and his undergraduate degree from Pennsylvania State University.

 

Mr. Tarriff brings to our Board of Directors significant knowledge of and experience in the pharmaceutical and medical industries. He has extensive business, managerial, executive and leadership experience that further qualify him to serve as a member of the Board and a valuable understanding of the role played by the Board of Directors acquired through service on the boards of many companies. He has had a long and successful career in top executive leadership positions with leading, publicly traded pharmaceutical companies including Par Pharmaceuticals Companies, Inc. and Bristol-Myers Squibb.

 

Jeffrey Wolf, J.D.   Mr. Wolf, a director since 2006, has substantial experience in creating, financing, nurturing and growing new ventures based upon breakthrough research and technology. In August 2008, Mr. Wolf founded Heat Biologics, Inc., a company engaged in research and development of drugs focused on combating cancer and other diseases. Since April 2010, Mr. Wolf has served as the Chief Executive Officer of Heat Biologics, Inc. From 2006 until April 2010, Mr. Wolf served as the Chairman and Chief Executive Officer of GenerationOne, a company that was focused on mobile-based collaborative care. Mr. Wolf is the founding partner of Seed-One Ventures, LLC, a venture capital group formed in 1997 and focused on seed-stage technology-based investments. Mr. Wolf has been a founder of Elusys Therapeutics, Inc., an antibody-based therapeutic company, Tyrx Pharma, Inc., a biopolymer-based company, Sensatex, Inc., a medical device company and Generation Mobile, Inc. a telecommunications company. Prior to founding Seed-One Ventures, Mr. Wolf served as the Managing Director of The Castle Group, Ltd., a biomedical venture capital firm. At both organizations, Mr. Wolf was responsible for supervising the formation and funding of new technology, biomedical, and service oriented ventures. Mr. Wolf currently sits on the board of Elusys Therapeutics and Netli, Inc. Mr. Wolf received an M.B.A. from Stanford Business School, a J.D. from New York University School of Law and a B.A. with honors in Economics from the University of Chicago.

 

Mr. Wolf has extensive knowledge of the industry and in particular research and development. His legal and business background provide him with a broad understanding of the legal, operational, financial and strategic issues facing Synthetic Biologics. Having served as a board member on other public company boards, Mr. Wolf has an extensive understanding of the operational, financial and strategic issues facing public companies. 

 

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Directors’ Term of Office

 

Directors will hold office until the next annual meeting of stockholders and the election and qualification of their successors. Officers are elected annually by our Board of Directors and serve at the discretion of the Board of Directors.

 

Audit Committee

 

The Audit Committee is comprised of Mr. Wolf and Mr. Tarriff. The Audit Committee is responsible for recommending our independent public accounting firm and reviewing management’s actions in matters relating to audit functions. The Committee reviews with our independent public accountants the scope and results of the audit engagement and the system of internal controls and procedures. The Committee also reviews the effectiveness of procedures intended to prevent violations of laws. The Committee also reviews, prior to publication, our reports on Form 10-K and Form 10-Q. Our Board has determined that all audit committee members are independent under applicable SEC regulations. Our Board of Directors has determined that both Mr. Wolf and Mr. Tarriff qualify as “audit committee financial experts” as that term is used in Section 407 of Regulation S-K.  Our Audit Committee charter is located on our website www.syntheticbiologics.com.

 

Compensation Committee

 

Our Compensation Committee consists of Mr. Wolf and Mr. Kraws. This committee performs several functions, including reviewing all forms of compensation provided to our executive officers, directors, consultants and employees, including stock compensation. Our Board has determined that all compensation committee members are independent under applicable SEC regulations. Our Compensation Committee charter is located on our website www.syntheticbiologics.com.

 

Nominations Committee

 

Our Nominations Committee consists of Mr. Kraws and Mr. Wolf. This committee performs several functions, including identifying qualified individuals to become members of the Board and recommending appointments to the Board and appointment of executive officers. The committee seeks individuals who have an inquisitive and objective perspective, practical wisdom and mature judgment, and the talent and expertise to understand, and provide sound and prudent guidance with respect to, our activities, operations and interests.  Candidates must also be individuals who have the highest personal and professional integrity, who have demonstrated exceptional ability and judgment, and who are likely to be the most effective, in conjunction with the other members of the Board, in collectively serving the long-term interests of stockholders. Our Board has determined that all nominations committee members are independent under applicable SEC regulations. Our Nominations Committee charter is located on our website www.syntheticbiologics.com.

 

Section 16(a) Beneficial Ownership Reporting Compliance

 

Section 16(a) of the Securities Exchange Act of 1934 requires our executive officers, directors and persons who beneficially own more than 10 percent of a registered class of the Synthetic Biologics’ equity securities, to file with the SEC initial reports of ownership and reports of changes in ownership of our common stock.  Such officers, directors and persons are required by SEC regulation to furnish us with copies of all Section 16(a) forms that they file with the SEC.

 

Based solely on a review of the copies of such forms that were received by us, or written representations from certain reporting persons that no Form 5s were required for those persons, we are not aware of any failures to file reports or report transactions in a timely manner during the year ended December 31, 2012.

 

Code of Ethics

 

We have long maintained a Code of Conduct which is applicable to all of our directors, officers and employees.  In addition, we have adopted a Code of Ethics for Financial Management which applies to our Chief Executive Officer, Chief Financial Officer, Treasurer and Controller.  Each of these codes is posted on our website at www.syntheticbiologics.com.

 

Item 11.          Executive Compensation

 

Summary Compensation Table

 

The following table summarizes all compensation awarded to, earned by or paid to Jeffrey Riley, C. Evan Ballantyne and James S. Kuo, M.D., during the fiscal years ended December 31, 2012 and 2011.

 

Name and Principal Position  Year   Salary ($)   Bonus ($)   Options
Awards($)  (1)		   All Other
Compensation
($)  (2)		   Total ($) 
Jeffrey Riley, President and CEO (3)   2012   $314,000   $52,000   $1,716,000   $7,000   $2,089,000 
                               
C. Evan Ballantyne, CFO (4)   2012   $267,000   $44,000   $1,044,000   $7,000   $1,362,000 
                               
James S. Kuo, M.D., President,   2012   $26,000   $-   $-   $11,000   $37,000 
CEO and CFO (5)   2011   $199,000   $-   $-   $12,000   $211,000 

 

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(1)Amount reflects the grant date fair value of the named executive officer’s stock options, calculated in accordance with FASB ASC Topic 718.  For a discussion of the assumptions used in calculating these values, see Note 6 to our consolidated financial statements
(2)The all other compensation column is comprised of the portion of medical, dental and vision premiums paid by us on behalf of our named executive officer. These benefits are offered to all full-time Synthetic Biologics employees.
(3)Mr. Riley was appointed as the Company’s President and Chief Executive Officer on February 3, 2012.
(4)Mr. Ballantyne was appointed as the Company’s Chief Financial Officer on February 6, 2012.
(5)Dr. Kuo resigned as our President, Chief Executive Officer and Chief Financial Officer on February 3, 2012. Dr. Kuo remained as a consultant to the Company until February 2013. Does not include $135,000 of consulting fees paid to Dr. Kuo during the year ended December 31, 2012.

 

Outstanding Equity Awards at Fiscal Year End

 

The table below reflects all outstanding equity awards made to each of the named executive officers that are outstanding at December 31, 2012. We currently grant stock-based awards pursuant to our 2010 Stock Incentive Plan (the “2010 Stock Plan”) and have outstanding awards under our 2001 Stock Incentive Plan (the “2001 Stock Plan”) and 2007 Stock Incentive Plan (the “2007 Stock Plan”).

 

Name  Grant   
Date (1)		     Number of Securities
Underlying
Unexercised Options
Exercisable		   Number of Securities
Underlying
Unexercised Options
Unexercisable		   Option
Exercise
Price ($)		   Option
Expiration
Date
Jeffrey Riley  02/03/12  (2)   208,333    541,667   $2.30   02/03/22
   11/17/11  (3)   62,500    37,500   $0.49   11/17/18
   01/05/11      25,000    -   $1.50   01/05/18
   12/01/10      8,333    -   $0.74   12/01/20
   03/03/10      25,000    -   $0.87   03/03/20
                         
C. Evan Ballantyne  02/06/12  (2)   118,056    306,944   $2.47   02/06/22
                         
James S. Kuo  02/06/10  (4)   260,000    -   $0.82   02/06/20
   12/22/09      8,333    -   $0.53   12/22/19
   10/02/08      8,333    -   $0.53   10/02/18
   11/02/07      8,333    -   $5.85   11/02/17
   02/07/07      25,000    -   $3.87   02/07/17

 

(1)Unless otherwise noted, options vest immediately on the date of grant.
(2)These options will vest pro rata, on a monthly basis, over thirty-six months.
(3)These options vest 12,500 shares immediately and the remainder in equal quarterly installments for seven quarters commencing on February 17, 2012.
(4)These options vest 100,000 shares immediately and the remainder in equal monthly installments over a three-year period beginning on the date of grant.

   

Employment Agreements

 

On February 3, 2012, Jeffrey Riley was appointed to serve as our Chief Executive Officer and President, and on February 6, 2012, C. Evan Ballantyne was appointed to serve as our Chief Financial Officer. On February 3, 2012, James S. Kuo, M.D., resigned as our Chief Executive Officer, President and Chief Financial Officer. Dr. Kuo remained as a consultant to the Company until February 2013. The following are summaries of the agreements that were executed in connection with these changes.

 

Jeffrey Riley Employment Agreement

 

In connection with his appointment, Mr. Riley entered into a three-year employment agreement with us (the “Riley Employment Agreement”). Pursuant to the Riley Employment Agreement, Mr. Riley will be entitled to an annual base salary of $348,000 and will be eligible for discretionary performance and transactional bonus payments. Additionally, Mr. Riley was granted options to purchase 750,000 shares of our common stock with an exercise price equal to our per share market price on the date of issue. These options will vest pro rata, on a monthly basis, over thirty-six months. The Riley Employment Agreement also includes confidentiality obligations and inventions assignments by Mr. Riley.

 

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If Mr. Riley’s employment is terminated for any reason, he or his estate as the case may be, will be entitled to receive the accrued base salary, vacation pay, expense reimbursement and any other entitlements accrued by him to the extent not previously paid (the “Accrued Obligations”); provided , however , that if his employment is terminated (1) by us without Just Cause (as defined in the Riley Employment Agreement) or by Mr. Riley for Good Reason (as defined in the Riley Employment Agreement) then in addition to paying the Accrued Obligations, (x) we shall continue to pay his then current base salary and continue to provide benefits at least equal to those which were provided at the time of termination for a period of six months and (y) he shall have the right to exercise any vested options until the earlier of the expiration of the severance or the expiration of the term of the option, or (2) by reason of his death or Disability (as defined in the Riley Employment Agreement), then in addition to paying the Accrued Obligations, he would have the right to exercise any vested options until the expiration of the term of the option. In such event, if Mr. Riley commenced employment with another employer and becomes eligible to receive medical or other welfare benefits under another employer-provider plan, the medical and other welfare benefits to be provided by us as described herein will terminate.

 

C. Evan Ballantyne Employment Agreement

 

Effective February 6, 2012, C. Evan Ballantyne was appointed our Chief Financial Officer. In connection with his appointment, Mr. Ballantyne entered into a three-year employment agreement with us (the “Ballantyne Employment Agreement”). Pursuant to the Ballantyne Employment Agreement, Mr. Ballantyne will be entitled to an annual base salary of $298,000 and will be eligible for discretionary performance and transactional bonus payments. Additionally, Mr. Ballantyne was granted options to purchase 425,000 shares of our common stock with an exercise price equal to our per share market price on the date of issue. These options will vest pro rata, on a monthly basis, over thirty-six months. The Ballantyne Employment Agreement also includes confidentiality obligations and inventions assignments by Mr. Ballantyne.

 

If Mr. Ballantyne’s employment is terminated for any reason, he or his estate as the case may be, will be entitled to receive the accrued base salary, vacation pay, expense reimbursement and any other entitlements accrued by him to the extent not previously paid (the “Accrued Obligations”); provided , however , that if his employment is terminated (1) by us without Just Cause (as defined in the Ballantyne Employment Agreement) or by Mr. Ballantyne for Good Reason (as defined in the Ballantyne Employment Agreement) then in addition to paying the Accrued Obligations, (i) we shall continue to pay his then current base salary and continue to provide benefits at least equal to those which were provided at the time of termination for a period of six months and (ii) he shall have the right to exercise any vested options until the earlier of the expiration of the severance or the expiration of the term of the option, or (2) by reason of his death or Disability (as defined in the Ballantyne Employment Agreement), then in addition to paying the Accrued Obligations, he would have the right to exercise any vested options until the expiration of the term of the option. In such event, if Mr. Ballantyne, commenced employment with another employer and becomes eligible to receive medical or other welfare benefits under another employer-provider plan, the medical and other welfare benefits to be provided by us as described herein will terminate.

  

Dr. Kuo’s Agreements

 

Effective February 3, 2012, James S. Kuo, M.D., resigned from his positions as our President and Chief Executive Officer. In connection with his resignation, Dr. Kuo entered into a nine-month consulting agreement with us (the “Consulting Agreement”). Pursuant to the Consulting Agreement, Dr. Kuo was entitled to a consulting fee of $16,666 per month during the term of the Consulting Agreement, receive health and dental benefits for one year and retain the right to exercise the stock options held by him that have vested as of the effective date of the Consulting Agreement for a period expiring on the date that is one (1) year from the effective date of the Consulting Agreement. The Consulting Agreement also includes confidentiality obligations and inventions assignments by Dr. Kuo.

 

In February 2010, Dr. Kuo had entered into a three-year employment agreement with us (the “Kuo Employment Agreement”).  Pursuant to the Kuo Employment Agreement, Dr. Kuo was entitled to an annual base salary of $199,000 and was eligible for discretionary performance and transactional bonus payments.  Additionally, Dr. Kuo was granted an initial stock option to purchase 400,000 shares of our common stock (with an exercise price of $0.82, the fair market value on February 6, 2010, which is the date of grant).  Of this stock option grant, 300,000 shares vested prior to his resignation.

  

Compensation of Directors

 

The following table sets forth information for the fiscal year ended December 31, 2012 regarding the compensation of our directors who at December 31, 2012 were not also named executive officers.

 

Name  Fees Earned or
Paid in Cash		   Option
Awards(1) (3)		   Other
Compensation		   Total 
Steve H. Kanzer  $2,000   $-   $-   $2,000 
Jeffrey J. Kraws (2)  $100,000   $169,000   $-   $269,000 
Scott Tarriff  $14,000   $57,000   $-   $71,000 
Jeffrey Wolf  $24,000   $-   $-   $24,000 

 

(1)The amounts in the “Option awards” column reflect the dollar amounts of the grant date fair value for the financial statement reporting purposes for stock options for the fiscal year ended December 31, 2012 in accordance with ASC 718. The fair value of the options was determined using the Black-Scholes model.
(2)Mr. Kraws was appointed as our independent, non-executive Chairman of the Board in May 2012. Pursuant to his agreement he will receive annual compensation of $150,000 and received a one-time grant of stock options exercisable for an additional 100,000 shares of our common stock.
(3)As of December 31, 2012, the following are the outstanding aggregate number of option awards held by each of our directors who were not also named executive officers:

 

Name  Option
Awards (#)		 
Steve H. Kanzer   304,391 
Jeffrey J. Kraws   387,105 
Scott Tarriff   25,000 
Jeffrey Wolf   83,332 

 

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During 2007, director compensation for independent members was approved at $2,000 per board meeting that they attend in person, $1,000 per telephonic board meeting and $500 per committee meeting.  In addition, we grant independent members of the Board of Directors upon appointment 25,000 stock options to purchase shares of our common stock at an exercise price equal to the fair market value of the our common stock on the date of grant, and an additional 25,000 stock options each year.  Directors who are employees, or who are compensated for board service pursuant to a separate agreement or arrangement, do not receive additional compensation for attending board, committee and stockholder meetings. We also reimburse directors for travel and other out-of-pocket expenses incurred in attending Board of Director and committee meetings.

 

Item 12.          Security Ownership of Certain Beneficial Owners

 

The following table sets forth information, as of March 27, 2013, or as otherwise set forth below, with respect to the beneficial ownership of our common stock (i) all persons know to us to be the beneficial owners of more than 5% of the outstanding shares of our common stock, (ii) each of our directors and our executive officer named in the Summary Compensation Table, and (iii) all of our directors and our executive officer as a group.

 

Principal Stockholders Table

 

   Shares Owned (1) 
Name and Address of Beneficial Ownership (2)  Number of Shares   Percentage of
Shares (3)		 
Accredited Venture Capital, LLC (4)   7,086,380    15.87%
Intrexon Corporation (5)   6,675,768    14.95%
NRM VII Holding I, LLC   3,125,000    7.00%
C. Evan Ballantyne (6)   177,083    * 
Steve H. Kanzer (7)   7,766,017    17.27%
Jeffrey J. Kraws (8)   349,605    * 
Jeffrey Riley (9)   468,733    1.04%
Scott L. Tarriff (10)   25,000    * 
Jeffrey Wolf (11)   83,332    * 
Randal J. Kirk(12)   9,800,768    21.95%
All officers and directors as a group (6 persons)   8,869,770    19.26%

 

* represents less than 1% of our common stock

 

(1)The address for each beneficial owner except Intrexon Corporation, NRM VII Holdings I, LLC and Randal J. Kirk is 155 Gibbs Street, Suite 412, Rockville, Maryland 20850.The address for Intrexon Corporation and NRM VII Holdings I, LLC is 20358 Seneca Meadows Pkwy, Germantown, Maryland 20876 and the address for Mr. Kirk is The Governor Tyler, 1881 Grove Avenue, Radford, Virginia 24141.
(2)Beneficial ownership is determined in accordance with SEC rules and generally includes voting or investment power with respect to securities. Except as indicated in the footnotes to the table, to the knowledge of the Company, the persons named in the table have sole voting and investment power with respect to all shares of common stock shown as beneficially owned by them, subject to community property laws, where applicable. Pursuant to the rules of the SEC, the number of shares of our common stock deemed outstanding includes shares issuable pursuant to options held by the respective person or group that are currently exercisable or may be exercised within 60 days of March 27, 2013.

 

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(3)As of March 27, 2013, we had 44,654,414 shares of common stock outstanding.
(4)Consists of 7,086,380 shares of common stock issued to Accredited Venture Capital, LLC. Pharmainvestors, LLC is the managing member of Accredited Venture Capital, LLC, and Mr. Kanzer is the managing member of Pharmainvestors, LLC. As such, Mr. Kanzer may be considered to have control over the voting and disposition of the shares registered in the name of Accredited Venture Capital, LLC, and therefore, such shares are also included in the shares listed as held by Mr. Kanzer. Mr. Kanzer disclaims beneficial ownership of those shares, except to the extent of his pecuniary interest.
(5)Does not include additional shares that have not yet been earned but may in the future be earned under the terms of agreements with Intrexon Corporation.

(6)Includes 177,083 shares issuable upon exercise of options held by Mr. Ballantyne that are exercisable within the 60-day period following March 27, 2013. Does not include an additional 247,917 shares issuable upon exercise of options held by Mr. Ballantyne that are not exercisable within the 60-day period following March 27, 2013.
(7)Includes 7,086,380 shares of common stock issued to Accredited Venture Capital, LLC and 304,391 shares issuable upon exercise of options held by Mr. Kanzer that are exercisable within the 60-day period following March 27, 2013.
(8)Includes 349,605 shares issuable upon exercise of options held by Mr. Kraws that are exercisable within the 60-day period following March 27, 2013. Does not include an additional 37,500 shares issuable upon exercise of options held by Mr. Kraws that are not exercisable within the 60-day period following March 27, 2013.

(9)Includes 458,333 shares issuable upon exercise of options held by Mr. Riley that are exercisable within the 60-day period following March 27, 2012. Does not include an additional 450,000 shares issuable upon exercise of options held by Mr. Riley that are not exercisable within the 60-day period following March 27, 2012.

(10)Includes 25,000 shares issuable upon exercise of options held by Mr. Tarriff that are exercisable within the 60-day period following March 27, 2012.
(11)Includes 83,332 shares issuable upon exercise of options held by Mr. Wolf that are exercisable within the 60-day period following March 27, 2012.
(12)All such shares are held by Intrexon Corporation and NRM VII Holdings I, LLC. Mr. Kirk, directly and through certain affiliates, has voting and dispositive power over a majority of the outstanding capital of Intrexon Corporation, and controls NRM VII Holdings I, LLC. Mr. Kirk disclaims beneficial ownership of the shares held by Intrexon Corporation and NRM VII Holdings I, LLC, except to the extent of any pecuniary interest therein.

 

Equity Compensation Plan Information

 

The following table sets forth information about the securities authorized for issuance under our equity compensation plans for the fiscal year ended December 31, 2012.

  

Plan Category  Number of Securities
to be Issued Upon
Exercise of
Outstanding Options		   Weighted-
Average
Exercise Price of
Outstanding
Options		   Number of Securities
Remaining Available for
Future Issuance Under
Equity Compensation
Plans		 
Equity compensation plans approved by stockholders:               
2001 Stock Incentive Plan   1,066,007   $1.38    60,190 
2007 Stock Incentive Plan   872,739   $1.62    283,101 
2010 Stock Incentive Plan   2,515,000   $2.01    481,530 
Equity compensation plans not approved by stockholder   N/A    N/A    N/A 
Total   4,453,746   $1.78    824,821 

 

Item 13.          Certain Relationships and Related Transactions, and Director Independence

 

Pursuant to our charter, our Audit Committee shall review on an on-going basis for potential conflicts of interest, and approve if appropriate, all our “Related Party Transactions” as required by Section 120 of the NYSE MKT Company Guide. For purposes of the Audit Committee Charter, “Related Party Transactions” shall mean those transactions required to be disclosed pursuant to SEC Regulation S-K, Item 404.

 

In February 2012, we entered into a Consulting Agreement with Dr. James Kuo. See Item 11- Executive Compensation for additional information regarding such agreement.

 

From January 2, 2012 through September 30, 2012, Steve H. Kanzer was engaged as our Interim Director of our Biologics Division. In connection with his appointment, Mr. Kanzer entered into a six month employment agreement with us on a full time basis (the “Kanzer Employment Agreement”), which may be extended for an additional three (3) months upon consent of the parties. Pursuant to the Kanzer Employment Agreement, Mr. Kanzer will be entitled to a base salary of $90,000 for the term, healthcare coverage pursuant to our healthcare insurance plan, reimbursement for certain relocation expenses and rent expense. The Kanzer Employment Agreement also includes confidentiality obligations and inventions assignments by Mr. Kanzer.  Mr. Kanzer is not entitled to severance pay upon termination of his employment. On October 1, 2012, the Kanzer Employment Agreement was amended (the “Amended Kanzer Employment Agreement”) and Mr. Kanzer is engaged as our Licensing Associate. In connection with this appointment, Mr. Kanzer entered into a two year agreement with us on a part time basis (2.5 days per week). Pursuant to the Amended Kanzer Employment Agreement, Mr. Kanzer will be entitled to a base salary of $150,000 for the term and healthcare coverage pursuant to our healthcare insurance plans.

 

In August 2012, we entered into an Exclusive Channel Agreement with Intrexon and issued 3,552,210 shares of common stock as consideration, having a fair value of $7.8 million ($2.20 per share), based on the quoted closing trading price on October 5, 2012 (date approved by our stockholders). In connection with the November 2011 and August 2012 Exclusive Channel Agreements, we paid Intrexon approximately $2.9 million during 2012, including a prepayment of research and development expenses of $2.5 million. In October 2012, we consummated our October 2012 Private Placement and entered into a stock purchase agreement with several investors, including NRM VII Holdings I, LLC, an entity affiliated with Intrexon. Randal J. Kirk may be deemed to indirectly beneficially own all of such shares. See Item 7 - Management’s Discussion and Analysis of Financial Conditions and Results of Operations for additional information regarding such issuance and agreements.

  

Item 14.          Principal Accountant Fees and Services

 

On July 3, 2012, we dismissed Berman & Company, P.A. as our independent registered public accounting firm, and on July 9, 2012, we selected BDO USA, LLP as our new independent registered public accounting firm responsible for auditing its financial statements.

 

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Independent Registered Public Accounting Firm Fees and Services

 

The following table sets forth the aggregate fees including expenses billed to us for the year ended December 31, 2012 by BDO USA, LLP.

 

   December 31,
2012		 
Audit Fees and Expenses(1)  $123,000 
   $123,000 

 

(1)Audit fees and expenses were for professional services rendered for the audit and reviews of the consolidated financial statements of the Company, professional services rendered for issuance of consents and assistance with review of documents filed with the SEC.

 

The Audit Committee has adopted procedures for pre-approving all audit and non-audit services provided by the independent registered public accounting firm, including the fees and terms of such services. These procedures include reviewing detailed back-up documentation for audit and permitted non-audit services. The documentation includes a description of, and a budgeted amount for, particular categories of non-audit services that are recurring in nature and therefore anticipated at the time that the budget is submitted. Audit Committee approval is required to exceed the pre-approved amount for a particular category of non-audit services and to engage the independent registered public accounting firm for any non-audit services not included in those pre-approved amounts. For both types of pre-approval, the Audit Committee considers whether such services are consistent with the rules on auditor independence promulgated by the SEC and the PCAOB. The Audit Committee also considers whether the independent registered public accounting firm is best positioned to provide the most effective and efficient service, based on such reasons as the auditor’s familiarity with our business, people, culture, accounting systems, risk profile, and whether the services enhance our ability to manage or control risks and improve audit quality. The Audit Committee may form and delegate pre-approval authority to subcommittees consisting of one or more members of the Audit Committee, and such subcommittees must report any pre-approval decisions to the Audit Committee at its next scheduled meeting. All of the services provided by the independent registered public accounting firm were pre-approved by your Audit Committee.

 

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PART IV

 

Item 15. Exhibits and Financial Statement Schedules and Reports on Form 8-K

 

(a)(1)The following financial statements are included in this Annual Report on Form 10-K for the fiscal years ended December 31, 2012 and 2011.

 

1.Independent Registered Public Accounting Firms

 

2.Consolidated Balance Sheets as of December 31, 2012 and 2011

 

3.Consolidated Statements of Operations for the years ended December 31, 2012 and 2011

 

4.Consolidated Statements of changes in Stockholders’ Equity for the years ended December 31, 2012 and 2011

 

5.Consolidated Statements of Cash Flows for the years ended December 31, 2012 and 2011

 

6.Notes to Consolidated Financial Statements

  

(a)(2)All financial statement schedules have been omitted as the required information is either inapplicable or included in the Consolidated Financial Statements or related notes.

 

(a)(3)The following exhibits are either filed as part of this report or are incorporated herein by reference:

 

3.1Certificate of Incorporation, as amended (Incorporated by reference to (i) Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed October 16, 2008, (ii) Exhibit 3.1 of the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2001 filed August 14, 2001 and (iii) Exhibits 3.1, 4.1 and 4.2 of the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 1998 filed August 14, 1998)
3.2Articles of Merger (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed October 19, 2009.)
3.3Certificate of Merger filed with the Secretary of State of Delaware (Incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed October 19, 2009.)
3.4Articles of Incorporation filed with the Nevada Secretary of State (Incorporated by reference to Exhibit 3.3 of the Registrant’s Current Report on Form 8-K filed October 19, 2009.)
3.5By-Laws (Incorporated by reference to (i) Exhibit 3.4 of the Registrant’s Current Report on Form 8-K filed October 19, 2009 and (ii) Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed June 3, 2010. )
3.6Amended and Restated Bylaws Adopted and Effective October 31, 2011 (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed October 2, 2011.)
3.7Certificate of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed February 16, 2012.)
4.1Form of Warrant Certificate (Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed December 1, 2006.)
*4.22001 Stock Incentive Plan (Incorporated by reference to Exhibit 4.1 of the Registrant’s Registration Statement on Form S-8 filed January 18, 2008.)
*4.32007 Stock Incentive Plan (Incorporated by reference to Exhibit 4.2 of the Registrant’s Registration Statement on Form S-8 filed January 18, 2008.)
*4.42010 Stock Incentive Plan (Incorporated by reference to Exhibit 4.1 of the Registrant’s Registration Statement on Form S-8 filed November 29, 2010.)
4.5Form of Warrant Certificate issued to Enclave Capital LLC (Incorporated by reference to Exhibit 4.1 of the Registrant’s Form 8-K filed July 6, 2010.)
4.6Form of Warrant to Purchase Common Stock issued January 2011(Incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed February 2, 2011.)
4.7Form of Warrant to Purchase Common Stock issued April 2011(Incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed April 6, 2011.)

 

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4.8Form of Exchange Warrant to Purchase Common Stock issued in exchange of the Warrant issued April 2011 (Incorporated by reference to Exhibit 4.1 of the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed August 15, 2011.)
4.9Form of Exchange Warrant to Purchase Common Stock issued in exchange of the Warrant issued February 2011 (Incorporated by reference to Exhibit 4.2 of the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed August 15, 2011.)
4.10Form of Warrant to Purchase Common Stock issued February 2012 (Incorporated by reference to Exhibit 4.10 of the Registrant’s Annual Report on Form 10-K for the year ended December 3, 2011 filed March 30, 2012.)
4.11Form of Warrant to Purchase Common Stock issued to Griffin Securities, Inc. on October 30, 2012 (Incorporated by reference to Exhibit 10.4 of the Registrant’s Current Report on Form 8-K filed October 31, 2012.)
4.12Form of Warrant Certificate issued to Redington, Inc. (Incorporated by reference to Exhibit 4.13 of the Registrant’s Registration Statement on Form S-1 filed on December 13, 2012.)

10.1Unit Purchase Agreement (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed December 1, 2006.)
10.2License Agreement between The Regents of the University of California and Epitope Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 10.22 of the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2008 filed August 14, 2008.)
*10.3Form of Director/Officer Indemnification Agreement (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed January 6, 2009.)
*10.4Warrant Cancellation and Registration Rights Agreement between Accredited Adventures Capital LLC and Adeona (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed January 20, 2009.)
10.5Stock Purchase Agreement with Neil O. Colwell and Connie Colwell (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed April 16, 2009.)
10.6Escrow Agreement Nayaran Torke (Incorporated by reference to Exhibit 10.5 of the Registrant’s Current Report on Form 8-K filed July 16, 2009.)
10.7Consulting Agreement with Nayaran Torke (Incorporated by reference to Exhibit 10.4 of the Registrant’s Current Report on Form 8-K filed July 16, 2009.)
10.8Purchase Agreement 1st Amendment HartLab LLC (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed July 16, 2009.)
10.9Purchase Agreement 2nd Amendment Hartlab LLC (Incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed July 16, 2009.)
10.10Agreement and Plan of Reincorporation Merger (Incorporated by reference to Exhibit 1.1 of the Registrant’s Current Report on Form 8-K filed October 19, 2009.)
*10.11Employment Agreement with James S. Kuo, M.D., (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed February 9, 2010.)
*10.12Separation Agreement with Max Lyons (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed February 9, 2010.)
10.13Sublicense Agreement between Meda AB, Adeona Pharamaceuticals, Inc. and Pipex Therapeutics, Inc. (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed May 11, 2010.)
10.14Non-Disturbance Agreement among Pipex Therapeutics, Inc., Mclean Hospital Corp and Meda AB (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed May 11, 2010.)
10.15Placement Agent Agreement with Enclave Capital LLC (Incorporated by reference to Exhibit 1.1 of the Registrant’s Current Report on Form 8-K filed July 6, 2010.)
10.16Common Stock Purchase Agreement with Seaside 88,LP (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed July 6, 2010.)
10.17Agreement with Chardan Capital Markets, LLC (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed February 2, 2011.)
10.18Securities Purchase Agreement with investors (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed February 2, 2011.)
10.19McLean Hospital Corporation Exclusive License Agreement (Incorporated by reference to Exhibit 10.21 of the Registrant’s Annual Report on Form 10-K filed March 31, 2011)
10.20Agreement with Chardan Capital Markets, LLC (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed April 6, 2011.)
10.21Securities Purchase Agreement with investors (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed April 6, 2011.)

 

63
 

 

10.22Exchange Agreement with respect to Warrant issued April 2011(Incorporated by reference to Exhibit 10.1 of the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed August 15, 2011.)
10.23Exchange Agreement with respect to Warrant issued February 2011(Incorporated by reference to Exhibit 10.2 of the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed August 15, 2011.)
10.24Exclusive Cannel Collaboration Agreement with Intrexon Corporation (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed November 21, 2011.)
10.25Stock Purchase Agreement with Intrexon Corporation (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed November 21, 2011.)
10.26Registration Rights Agreement with Intrexon Corporation (Incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed November 21, 2011.)
*10.27Employment Agreement with Jeffrey Riley (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed February 6, 2012.)
10.28Consulting Agreement with Dr. James Kuo (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed February 6, 2012.)
*10.29Employment Agreement with C. Evan Ballantyne (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed February 7, 2012.)
*10.30Employment Agreement with Steve H. Kanzer (Incorporated by reference to Exhibit 10.30 of the Registrant’s Annual Report on Form 10-K for the year ended December 3, 2011 filed March 30, 2012.)

10.31Membership Interest Purchase Agreement by and among Synthetic Biologics, Inc., Hartlab LLC, and Adeona Clinical Laboratory, LLC, dated as of March 7, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed March 12, 2012.)
10.32Pledge and Security Agreement between Synthetic Biologics, Inc. and Hartlab, LLC dated as of March 7, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed March 12, 2012.)
10.33Non-Recourse Promissory Note between Synthetic Biologics, Inc. and Hartlab, LLC dated as of March 7, 2012 (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed March 12, 2012.)
10.34Financial Advisory Agreement with Griffin Securities, Inc. (Incorporated by reference to Exhibit 10.34 of the Registrant’s Annual Report on Form 10-K for the year ended December 3, 2011 filed March 30, 2012.)
10.35Exclusive Channel Collaboration Agreement with Intrexon Corporation (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed August 9, 2012.)
10.36Stock Purchase Agreement with Intrexon Corporation (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed August 9, 2012.)
10.37First Amendment to Registration Rights Agreement between Synthetic Biologics, Inc. and Intrexon Corporation (Incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed August 9, 2012.)
10.38Stock Purchase Agreement dated October 25, 2012 with investors (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed October 31, 2012.)
10.39Registration Rights Agreement dated October 25, 2012 with investors (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed October 31, 2012.)
10.40Joinder Agreement by and among Synthetic Biologics, Inc., NRM VII Holdings I, LLC and Intrexon Corporation (Incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed October 31, 2012.)
10.41Asset Purchase Agreement dated November 8, 2012 between Synthetic Biologics, Inc. and Prev ABR LLC (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed November 13, 2012.)
*10.42Amendment to Employment Agreement dated October 1, 2012 with Steve H. Kanzer (Incorporated by reference to Exhibit 10.42 of the Registrant’s Registration Statement on Form S-1 filed December 13, 2012.)
10.43Patent License Agreement dated December 19, 2012 between Synthetic Biologics, Inc. and The University of Texas at Austin (Incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed December 21, 2012.)
10.44Sponsored Research Agreement dated December 19, 2012 between Synthetic Biologics, Inc. and The University of Texas at Austin (Incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed December 21, 2012.)
 10.45Exclusive License Agreement with The Regents of The University of California (1)
10.46First Amendment to Exclusive License Agreement with The Regents of The University of California (1)
 10.47Second Amendment to Exclusive License Agreement with The Regents of The University of California (1)
 10.48Third Amendment to Exclusive License Agreement with The Regents of The University of California (1)
 10.49Fourth Amendment to Exclusive License Agreement with The Regents of The University of California (1)

  

 

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21List of Subsidiaries (Incorporated by reference to Exhibit 10.34 of the Registrant’s Annual Report on Form 10-K filed March 30, 2012.)

 

23.1Consent of Independent Registered Public Accounting Firm (BDO USA, LLP) (1)

 

23.2Consent of Independent Registered Public Accounting Firm (Berman & Company, P.A.) (1)

 

31.1Certification of Jeffrey Riley, Chief Executive Officer, pursuant to Rule 13a-14(a)/15d-14(a) (1)

 

31.2Certification of C. Evan Ballantyne, Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) (1)

 

32.1Certification of Jeffrey Riley, Chief Executive Officer pursuant to Section 1350 of the Sarbanes-Oxley Act of 2002 (1)

 

32.2Certification C. Evan Ballantyne, Chief Financial Officer pursuant to Section 1350 of the Sarbanes-Oxley Act of 2002 (1)

 

**+101.INS XBRL Instance Document

**+101.SCH XBRL Taxonomy Extension Schema Document

**+101.CAL XBRL Taxonomy Extension Calculation Linkbase Document

**+101.DEF XBRL Taxonomy Extension Definition Linkbase Document

**+101.LAB XBRL Taxonomy Extension Label Linkbase Document

**+101.PRE XBRL Taxonomy Extension Presentation Linkbase Document

 

(1) Filed herewith.

* Management contract or compensatory plan or arrangement required to be identified pursuant to Item 15(a)(3) of this report

** As provided in Rule 406T of Regulation S-T, this information is deemed furnished and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933, as amended, and Section 18 of the Securities Exchange Act of 1934, as amended.

 

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SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned.

 

  SYNTHETIC BIOLOGICS, INC.
  By: /s/ Jeffrey Riley  
  Jeffrey Riley
  Chief Executive Officer and Director
  (Principal Executive Officer)
  Date: April 16, 2013

 

  By: /s/ C. Evan Ballantyne  
  C. Evan Ballantyne
  Chief Financial Officer
  (Principal Financial and Principal Accounting Officer)
  Date: April 16, 2013

 

Pursuant to the requirements of the Securities Act of 1934, this report has been signed by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

 

    By: /s/ Jeffrey Riley  
Date: April 16, 2013   Jeffrey Riley
    Chief Executive Officer and Director
    (Principal Executive Officer)

     
Date: April 16, 2013   By: /s/ Jeffrey J. Kraws  
    Jeffrey J. Kraws
    Chairman

     
Date: April 16, 2013   By: /s/ Steve H. Kanzer  
    Steve H. Kanzer
    Director

     
Date: April 16, 2013   By: /s/ Scott L. Tarriff  
    Scott L. Tarriff
    Director
     
Date: April 16, 2013   By: /s/ Jeffrey Wolf  
    Jeffrey Wolf
    Director

 

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GLOSSARY

 

Term   Definition
Adverse Event   Any adverse change in health or “side-effect” that occurs in a person participating in a clinical trial, from the time they consent to joining the trial until a pre-specified period of time after their treatment has been completed.
     
Bioavailability   The quantity or fraction of the ingested dose that is absorbed by the body.
     
BLA - Biologics License Application   An application in the U.S. through which biologic sponsors formally propose that the FDA approve a new biologic for sale and marketing.
     
Clinical Study/Trial   A research study that is conducted to find out if a treatment or procedure is safe and/or effective in humans.
     
Controlled Clinical Trial   A clinical study that compares patients receiving a specific treatment to patients receiving an alternate treatment for the condition of interest. The alternate treatment may be another active treatment, standard of care for the condition and/or a placebo (inactive) treatment.
     
Double-blinded Study/Trial   Both the participant and the researcher are unaware of who is receiving the active treatment or the placebo.
     
Effirma (flupirtine)   Proposed tradename of Synthetic Biologics’ centrally-acting investigational oral drug for the treatment of fibromyalgia syndrome.
     
FDA - Food & Drug Administration   The U.S. government agency that ensures that medicines, medical devices, prescription medical foods and radiation-emitting consumer products are safe and effective. Authorized by Congress to enforce the Federal Food, Drug, and Cosmetic Act and several other public health laws, the agency monitors the manufacture, import, transport, storage, and sale of $1 trillion worth of goods annually.
     
GMP - Good Manufacturing Practice   Regulations that require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are consistently produced, pure, and stable. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.
     
Monoclonal Antibodies (mAbs)   Acting as the body's army, antibodies are proteins, generally found in the bloodstream, that provide immunity in detecting and destroying pathogens, such as viruses and bacteria and their associated toxins.
     
IND - Investigational New Drug   An application in the U.S. submitted to the FDA for a new drug or biologic that, if allowed, will be used in a clinical trial.
     
IRB - Institutional Review Board   A committee designated to formally approve, monitor, and review biomedical research at an institution involving human studies. Institutional Review Boards aim to protect the rights and welfare of the research subjects.
     
NDA - New Drug Application   An application in the U.S. through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
     
Open-label Clinical Study/Trial   A trial in which both the treating physician and the patient know they are receiving the experimental treatment.
     
Phase I Clinical Trial   A Phase I trial represents an initial study in a small group of patients to primarily test for safety.

 

 

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Phase II Clinical Trial   A Phase II trial represents a study in a larger number of patients to assess the safety and efficacy of a product.
     
Phase III Clinical Trial   Phase III trials are initiated to establish safety and efficacy in an expanded patient population and at multiple clinical trial sites and are generally larger than trials in earlier phases of development.
     
Placebo   An inactive pill or liquid. Many studies compare an active drug to a placebo to determine whether any changes seen during the study can be attributed to the active drug.
     
Principal Investigator   This is the study director who is ultimately responsible for the conduct of the study.
     
Prospective Clinical Study/Trial   A clinical study/trial in which participants are identified and then followed throughout the study going forward in time.
     
Protocol   A clinical study/trial’s plan - includes the schedule of tests, requirements for participation, procedures, and medications.
     
Randomized Study/Trial   Participants in a study are assigned by chance to either one or more of the active treatment group(s) or the placebo group.
     
Single-blinded Study/Trial   One party, either the participant or the researcher, does not know if the participant is taking the active treatment or the placebo.
     
Study/Trial Coordinator   Staff member who is often the primary contact for research participants and coordinates their care and evaluations throughout the study. 
     
Synthetic Biology  

Synthetic biology is an emerging field that combines molecular biology and automation to design, optimize and construct new biological systems and functions.

 

These technologies utilize a combination of automated processes including, DNA sequencing, computer-aided design, DNA synthesis, fabrication of modular transgenes and high throughput testing to create and optimize biologic products.

     
Trimesta (oral estriol)   Proposed tradename of Synthetic Biologics’ investigational oral drug for the treatment of relapsing- remitting MS and cognitive dysfunction in MS.

 

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 EX-10.45 2 v337358_ex10-45.htm EXHIBIT 10.45

 

Exhibit 10.45

 

EXCLUSIVE LICENSE AGREEMENT

 

This Agreement is made and is effective this 11th day of July 2005 (the "Effective Date") between THE REGENTS OF THE UNIVERSITY OF CALIFORNIA ("The Regents"), a California corporation having its corporate offices located at 1111 Franklin Street, Oakland, California 94607-5200, acting through its offices located at 10920 Wilshire Blvd, Suite 1200, Los Angeles, California 90024-1406, and General Fiber, Inc ("Licensee"), a corporation having a principal place of business at 801 Brickell Avenue, 9th Floor, Suite 942, Miami, FL 33131.

 

RECITALS

 

WHEREAS, a certain invention (the "Invention"), generally characterized as "Estriol for the treatment of autoimmune diseases & the use of estriol and other estranges, estrogens and estrogen receptor active compositions in the treatment of psoriasis & other autoimmune diseases" (UCLA Case No. 1998-531 & UCLA Case No. 2004-101) made in the course of research at the University of California, Los Angeles and Irvine by Drs. Rhonda Voskuhl, Jenny Murase, and Gerald Weinstein), and claimed in Regents' Patent Rights as defined below;

 

WHEREAS, Drs. Voskuhl, Murase, ~and Weinstein are an employees of The Regents and as such are obligated to assign their right, title and interest in and to the Invention to The Regents;

 

WHEREAS, the Invention was developed with United States Government funds, and The Regents has elected title thereto and granted a royalty-free nonexclusive license to the United States Government on 11-14-97, as required under 35 U.S.C. §200-212;

 

WHEREAS, Licensee and The Regents entered into a Secrecy Agreement effective 10-20-03 and expiring on 10-20-08 to allow Licensee to evaluate its interest in the Invention and, as a result of its evaluation, Licensee wishes to obtain certain rights from The Regents;

 

WHEREAS, Licensee is a "small business concern" as defined in 15 U.S.C. §632; and

 

WHEREAS, The Regents wishes that Regents' Patent Rights be developed and utilized to the fullest extent so that the benefits can be enjoyed by the general public.

 

The parties agree as follows:

 

1. DEFINITIONS

 

1.1 "Regents' Patent Rights" means The Regents interest in any of the patent applications listed in Appendix A attached to this Agreement and assigned to The Regents (UCLA Case No. 1998-531 & UCLA Case No. 2004-101); any continuing applications thereof including divisions; but excluding continuations-in-part except to the extent of claims entirely supported in the specification and entitled to the priority date of the parent application; any patents issuing on these applications including reissues and reexaminations; and any corresponding foreign patents or patent applications; all of which will be automatically incorporated in and added to Appendix A and made a part of this Agreement.

 

 
 

 

1.2 "Licensed Product" means any article, composition, apparatus, substance, chemical, or any other material covered by Regents' Patent Rights or whose manufacture, use or sale would constitute an infringement of any claim within Regents' Patent Rights, or any service, article, composition, apparatus, chemical, substance, or any other material made, used, or sold by or utilizing or practicing a Licensed Method. This definition of Licensed Product also includes a service either used by Licensee, an Affiliate, or sublicensee or provided by Licensee, an Affiliate or sublicensee to its customers when such service requires the use of Licensed Product or performance of Licensed Method. Additionally, for the avoidance of doubt, if such product is a component of a larger unit such as a kit, composition of matter or combination, such kit, composition of matter or combination is deemed to be the Licensed Product for purposes of this definition.

 

1.3 "Licensed Method" means any process or method which is covered by Regents' Patent Rights or whose use or practice would constitute an infringement of any claim within Regents' Patent Rights.

 

1.4 The "Field of Use" means all fields for the first two years after the Effective Date of the Agreement. On the second anniversary of the Effective Date of the Agreement Licensee will select fields of use and for each field will be required to meet the diligence terms outlined in paragraph 6.3 below.

 

1.5 "Affiliate" means any corporation or other business entity in which Licensee owns or controls, directly or indirectly, at least 50% of the outstanding stock or other voting rights entitled to elect directors. In any country where the local law does not permit foreign equity participation of at least 50%, then "Affiliate" means any company in which Licensee owns or controls, directly or indirectly, the maximum percentage of outstanding stock or voting rights that is permitted by local law.

 

1.6 "First Commercial Sale" means the first sale of any Licensed Product by Licensee or any Affiliate or Sublicensee, following approval of it's marketing by the appropriate governmental agency for the country in which the sale is to be made. When governmental approval is not required, "First Commercial Sale" means the first sale in that country.

 

1.7 "Final Sale" means any sale, transfer, lease, exchange or other disposition or provision of a Licensed Product and/or a Licensed Method to a Customer. A Final Sale shall be deemed to have occurred upon the earliest to occur of the following (as applicable): (a) the transfer of title to such Licensed Product and/or Licensed Method to a Customer, (b) the shipment of such Licensed Product to a Customer, (c) the provision of a Licensed Method to a Customer, (d) the provision of an invoice for such Licensed Product or Licensed Method to a Customer, or (e) payment by the Customer for Licensed Products or Licensed Methods.

 

1.8 "Net Sales" means the total of the gross amount invoiced or otherwise charged (whether consisting of cash or any other forms of consideration) for the Final Sale of Licensed Products or Licensed Methods by Licensee, or by any Affiliate, Joint Venture or Sublicensee to Customers, less the following deductions (to the extent included in and not already deducted from the gross amount invoiced or otherwise charged) to the extent reasonable and customary: cash, trade or quantity discounts actually granted to Customers; sales, use, tariff, import/export duties or other excise taxes imposed on particular sales (excepting value added taxes or income taxes); transportation charges, including insurance to the extent actually paid by the Customer; and allowances or credits to Customers because of rejections or returns. Where Licensee or any Affiliate, Joint Venture or Sublicensee is the Customer, then Net Sales shall be based on the gross amount normally invoiced or otherwise charged to other Customers in an arms length transaction for such Licensed Products or Licensed Methods. For the avoidance of doubt, if Licensee or any Affiliate, Joint Venture or Sublicensee supplies (directly or indirectly) a Product that constitutes a 8-Jul-05 Licensed Product to any Affiliate, Joint Venture or Sublicensee and such Affiliate, Joint Venture or Sublicensee includes such Product in another Product, then Net Sales shall be based on the total gross amount invoiced or otherwise charged for such other Product in its entirety. If License pays a third party royalties in consideration for patent rights which are necessary in order to practice Regents' Patent Rights then Licensee or Sublicensee, as the case may be may deduct .333% from the royalty rate due to The Regents under this Agreement for every percentage point paid to third party in royalties, provided that in no event shall royalties or other amounts due to The Regents in any reporting period be reduced to less than 50% of what would otherwise be due to The Regents.

 

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1.9 "Sublicensee" means any third party sublicensed by Licensee to make, have made, use, sell, offer for sale or importany Licensed Product or to practice any Licensed Method.

 

1.10 "Sublicensing Income" means income received by Licensee under or on account of Sublicenses. Sublicensing Income includes income received by way of license issue fees, milestone payments, and the like but specifically excludes royalties on the sale or distribution of Licensed Products or the practice of Licensed Methods. Not included in the definition of Sublicensing Income is income received by Licensee as payment or reimbursement for research costs conducted by or for Licensee, including costs associated with materials, equipment or clinical testing and amounts received in connection with the issuance of debt or equity.

 

1.11 "Customer" means any individual or entity that receives Licensed Products or Licensed Methods, provided however, that Licensee or any Affiliate, Joint Venture or Sublicensee shall be deemed a Customer only if it receives Licensed Products or Licensed Services for its own end-use and not resale.

 

2. GRANT

 

2.1 Subject to the limitations set forth in this Agreement, The Regents hereby grants to Licensee an exclusive license (the "License") under Regents' Patent Rights, in jurisdictions where Regents' Patent Rights exist, to make, have made, use, sell, offer for sale and import Licensed Products and to practice Licensed Methods in the Field of Use to the extent permitted by law.

 

2.2 The License is subject to all the applicable provisions of any license to the United States Government executed by The Regents and is subject to any overriding obligations to the United States Federal Government under 35 U.S.C. §§200-212 and applicable governmental implementing regulations.

 

2.3 The Regents expressly reserves the right to use Regents' Patent Rights and associated technology for educational and research purposes including publication of research results and sharing research results with other non-profit institutions, and allowing other non-profit research institutions to use Regents' Patent Rights and associated technology for the same purpose.

 

3. SUBLICENSES

 

3.1 The Regents also grants to Licensee the right to issue exclusive or nonexclusive sublicenses ("Sublicenses") to third parties to make, have made, use sell, offer for sale or import Licensed Products and to practice Licensed Methods in any jurisdiction in which Licensee has exclusive rights under this Agreement. To the extent applicable, sublicenses must include all of the rights of and obligations due to The Regents (and, if applicable, the U.S. Government under 35 U.S. C. §§201-212) contained in this Agreement.

 

3.2 Licensee must pay to The Regents 25% of all Sublicensing Income.

 

3.3 On Net Sales of Licensed Products sold or disposed of by a Sublicensee, Licensee must pay to The Regents an earned royalty in accordance with Article 5 (Royalties) as if these were Licensee's Net Sales. Any royalties received by Licensee in excess of royalties due to The Regents under this Paragraph 3.3 belong to Licensee.

 

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3.4 Licensee must provide to The Regents a copy of each Sublicense within 30 days of execution, and a copy of all information submitted to Licensee by Sublicensees relevant to the computation of the payments due to The Regents under this Article 3.

 

3.5 If this Agreement is terminated for any reason, all outstanding Sublicenses, not in default, will be assigned by Licensee to The Regents, at the option of The Regents. The Sublicenses will remain in full force and effect with The Regents as the licensor or sublicensor instead of Licensee, but the duties of The Regents under the assigned Sublicenses will not be greater than the duties of The Regents under this Agreement, and the rights of The Regents under the assigned Sublicenses will not be less than the rights of The Regents under this Agreement, including all financial consideration and other rights of The Regents.

 

4. FEES

 

4.1 In partial consideration for the License, Licensee will pay to The Regents a license issue fee of twenty thousand dollars ($20,000) within 30 days of the Effective Date and twenty five thousand dollars ($25,000) on the first anniversary of this Agreement. This fee is nonrefundable and is not an advance against royalties.

 

4.2 For each Licensed Product reaching the milestones indicated below, Licensee must make the following payments to The Regents within 30 days of reaching the milestones:

 

  4.2a One hundred thousand dollars ($100,000) upon the NDA filing with the U.S. Food and Drug Administration which is covered by a validly issued U.S. patent.
     
  4.2b Six hundred fifty thousand dollars ($650,000) upon approval of an NDA with the U.S. Food and Drug Administration which is covered by a validly issued U.S. patent

 

4.3 Licensee must pay to The Regents a license maintenance fee of $ 5,000 beginning on the one-year anniversary date of the Effective Date of this Agreement and continuing annually on each anniversary date of the Effective Date. The maintenance fee will not be due and payable on any anniversary date of the Effective Date if on that date Licensee is commercially selling a Licensed Product and paying an earned royalty to The Regents on the sales of that Licensed Product. The license maintenance fees are non-refundable and are not an advance against royalties.

 

4.4 In the event that the Licensee is publicly traded, Licensee shall make, at The Regents' election, payment under sections 4.1, 4.2 & 4.3 with Licensee's publicly traded equity.

 

5. ROYALTIES

 

5.1 Licensee must pay to The Regents for sales by Licensee or its Affiliates an earned royalty of four percent (4%) of Net Sales of Licensed Products or Licensed Methods unless reduced pursuant to Section 1.8.

 

5.2 Licensee must pay to The Regents a minimum annual royalty of $10,000 for the life of Regents' Patent Rights, beginning in the year of the First Commercial Sale of Licensed Product. Licensee must pay the minimum annual royalty to The Regents by February 28 of each year. The minimum annual royalty will be credited against the earned royalty due and owing for the calendar year in which the minimum payment was made.

 

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5.3 Paragraphs 1.1, 1.2, 1.3 and 1.4 define Regents' Patent Rights, Licensed Products, Licensed Methods and the Field of Use so that royalties are payable on products covered by pending patent applications and issued patents. Royalties accrue for the duration of this Agreement.

 

5.4 Licensee must pay royalties owed to The Regents on a quarterly basis. Licensee must pay the royalties within two months of the end of the calendar quarter in which the royalties accrued.

 

5.5 All monies due The Regents must be paid in United States funds. When Licensed Products are sold for monies other than United States dollars, the royalties will first be determined in the foreign currency of the country in which those Licensed Products were sold and, second, converted into equivalent United States funds. Licensee must use the exchange rate established by the Bank of America in San Francisco, California on the last day of the calendar quarter.

 

5.6 Any tax for the account of The Regents required to be withheld by Licensee under the laws of any foreign country must be promptly paid by Licensee for and on behalf of The Regents to the appropriate governmental authority. Licensee will use its best efforts to furnish The Regents with proof of payment of any tax. Licensee is responsible for all bank transfer charges. All payments made by Licensee in fulfillment of The Regents' tax liability in any particular country will be credited against fees or royalties due The Regents for that country.

 

5.7 If at any time legal restrictions prevent the acquisition or prompt remittance of United States Dollars by Licensee with respect to any country where a Licensed Product is sold, the Licensee shall pay royalties due to The Regents from Licensee's other sources of United States Dollars.

 

5.8 If any patent or any claim included in Regents' Patent Rights is held invalid or unenforceable in a final decision by a court of competent jurisdiction from which no appeal has or can be taken, all obligation to pay royalties based on that patent or claim or any claim patentably indistinct from it will cease as of the date of that final decision. Licensee will not, however, be relieved from paying any royalties that accrued before that decision or that is based on another patent or claim not involved in that decision.

 

5.9 No royalties will be collected or paid on Licensed Products sold to the United States Federal Government, or any agency of the United States Government. The Licensee and its Sublicensee will reduce the amount charged for Licensed Products distributed to the United States Government by the amount of the royalty.

 

6. DILIGENCE

 

6.1 Upon the execution of this Agreement, Licensee must diligently proceed with the development, manufacture and sale ("Commercialization") of Licensed Products and must earnestly and diligently endeavor to market them within a reasonable time after execution of this Agreement and in quantities sufficient to meet the market demands for them.

 

6.2 Licensee must endeavor to obtain all necessary governmental approvals for the Commercialization of Licensed Products.

 

6.3 The Regents has the right and option to either terminate this Agreement, narrow the fields of use granted under paragraph 1.4 or reduce Licensee's exclusive license to a nonexclusive license if Licensee fails to perform any of the terms in this Paragraph 6.3. This right, if exercised by The Regents, supersedes the rights granted in Article 2 (Grant).

 

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6.3a Within twenty-four months from the Effective Date of this Agreement, Licensee will file, cross-file or transfer an investigational new drug application (IND) relating to the Licensed Product for each field of use selected under paragraph 1.4 of this Agreement.

 

6.3b Within five years of the Effective Date of this Agreement, initiate Phase II clinical trials for a Licensed Product for each field of use selected under paragraph 1.4 of this Agreement.

 

6.3c Within eight years of the Effective Date of this Agreement, initiate Phase III clinical trials for a Licensed Products for each field of use selected under paragraph 1.4 of this Agreement.

 

6.3d Within fourteen years of the Effective Date of this Agreement complete a First Commercial Sale of a Licensed Product for each field of use selected under paragraph 1.4 of this Agreement.

 

6.4 Licensee has the sole discretion for making all decisions as to how to commercialize any Licensed Product.

 

7. PATENT FILING, PROSECUTION AND MAINTENANCE

 

7.1 As long as Licensee is paying prosecution costs, The Regents will file, prosecute and maintain the patents and applications comprising Regents' Patent Rights. These patents will be held in the name of The Regents and will be obtained with counsel of The Regents' choice. The Regents must provide Licensee with copies of each patent application, office action, response to office action, request for terminal disclaimer, and request for reissue or reexamination of any patent or patent application under Regents' Patent Rights. The Regents will consider any comments or suggestions by Licensee: The Regents is entitled to take action to preserve rights and minimize costs whether or not Licensee has commented.

 

7.2 Licensee will bear all costs incurred prior to and during the term of this Agreement in the preparation, filing, prosecution and maintenance of patent applications and patents in Regents' Patent Rights. Prosecution includes interferences, oppositions and any other inter parties matters originating in a patent office. Licensee must send payment to The Regents within 30 days of Licensee's receipt of an invoice.

 

7.3 Licensee has the right to request patent protection on the Invention in foreign countries if the rights are available. Licensee must notify The Regents of its decision within eight months of the filing of the corresponding United States patent application. This notice must be in writing and must identify the countries desired. The absence of this notice from Licensee to The Regents will be considered an election not to secure foreign rights.

 

7.4 Eight months after the filing of the corresponding United States application, but not sooner, The Regents will have the right to file patent applications at its own expense in any country which Licensee has not identified in written notice provided by 7.3. These applications and resulting patents will not be subject to this Agreement.

 

7.5 Licensee's obligation to underwrite and to pay all United States and foreign patent costs will continue for as long as this Agreement remains in effect. Licensee may terminate its obligations with respect to any given patent application or patent upon three months written notice to The Regents. The Regents will use its best efforts to curtail patent costs chargeable to Licensee under this Agreement after this notice is received from Licensee. The Regents may continue prosecution or maintenance of these application(s) or patent(s) at its sole discretion and expense, and Licensee will have no further rights or licenses to them.

 

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7.6 The Regents will use its best efforts to not allow any Regents' Patent Rights for which Licensee is licensed and is underwriting the costs of to lapse or become abandoned without Licensee's authorization or reasonable notice, except for the filing of continuations, divisionals, or the like which substitute for the lapsed application.

 

8. PATENT INFRINGEMENT

 

8.1 In the event that The Regents (to the extent of the actual knowledge of the licensing professional responsible for the administration of this Agreement) or the Licensee learns of infringement of potential commercial significance of any patent licensed under this Agreement, the knowledgeable party will provide the other (i) with written notice of such infringement and (ii) with any evidence of such infringement available to it (the "Infringement Notice"). During the period in which, and in the jurisdiction where, the Licensee has exclusive rights under this Agreement, neither The Regents nor the Licensee will notify a third party (including the infringer) of infringement or put such third party on notice of the existence of any Patent Rights without first obtaining consent of the other. If the Licensee puts such infringer on notice of the existence of any Patent Rights with respect to such infringement without first obtaining the written consent of The Regents and if a declaratory judgment action is filed by such infringer against The Regents, then Licensee's right to initiate a suit against such infringer for infringement under Paragraph 8.2 below will terminate immediately without the obligation of The Regents to provide notice to the Licensee. Both The Regents and the Licensee will use their diligent efforts to cooperate with each other to terminate such infringement without litigation.

 

8.2 If infringing activity of potential commercial significance by the infringer has not been abated within ninety (90) days following the date the Infringement Notice takes effect, then the Licensee may institute suit for patent infringement against the infringer. The Regents may voluntarily join such suit at its own expense, but may not thereafter commence suit against the infringer for the acts of infringement that are the subject of the Licensee's suit or any judgment rendered in the suit. The Licensee may not join The Regents in a suit initiated by Licensee without The Regents' prior written consent. If, in a suit initiated by the Licensee, The Regents is involuntarily joined other than by the Licensee, then the Licensee will pay any costs incurred by The Regents arising out of such suit, including but not limited to, any legal fees of counsel that The Regents selects and retains to represent it in the suit.

 

8.3 If, within a hundred and twenty (120) days following the date the Infringement Notice takes effect, infringing activity of potential commercial significance by the infringer has not been abated and if the Licensee has not brought suit against the infringer, then The Regents may institute such suit for patent infringement against the infringer. If The Regents institutes such suit, then the Licensee may not join such suit without The Regents consent and may not thereafter commence suit against the infringer for acts of infringement that are subject to The Regents suit or any judgment rendered in that suit.

 

8.4 Any recovery or settlement received in connection with any suit will first be shared by The Regents and the Licensee equally to cover any litigation costs each incurred and next shall be paid to The Regents or the Licensee to cover any litigation costs it incurred in excess of the litigation costs of the other. In any suit initiated by the Licensee, any recovery in excess of litigation costs will be shared between Licensee and The Regents as follows: (a) for any recovery other than amounts paid for willful infringement: (i) The Regents will receive fifteen percent (15%) of the recovery if The Regents was not a party in the litigation and did not incur any litigation costs, (ii) The Regents will receive twenty-five percent (25%) if The Regents was party in the litigation, but did not incur any litigation costs, including provisions of Paragraph 8.2 above, and (iii) The Regents will receive fifty percent (50%) of the recovery if The Regents incurred any litigation costs in connection with the litigation; and (b) for any recovery for willful infringement, The Regents will receive fifty percent (50%) of the recovery. In any suit initiated by The Regents, any recovery in excess of litigation costs will belong to The Regents. The Regents and the Licensee agree to be bound by all determinations of patent infringement, validity and enforceability (but no other issue) resolved by any adjudicated judgment in a suit brought in compliance with this Article 8 (Patent Infringement).

 

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8.5 Any agreement made by the Licensee for purposes of settling litigation or other dispute shall comply with the requirements of Article 3 (Sublicenses) of this Agreement.

 

8.6 Each party will cooperate with the other in litigation proceedings instituted hereunder but at the expense of the party who initiated the suit (unless such suit is being jointly prosecuted by the parties).

 

8.7 Any litigation proceedings will be controlled by the party bringing the suit, except that The Regents may be represented by counsel of its choice in any suit brought by the Licensee.

 

9. PROGRESS AND ROYALTY REPORTS

 

9.1 Beginning January 31, 2006, Licensee must submit to The Regents semiannual progress reports covering Licensee's activities related to the development and testing of all Licensed Products and the obtaining of the governmental approvals necessary for marketing. These progress reports must be made for each Licensed Product until its First Commercial Sale.

 

9.2 The progress reports submitted under Paragraph 9.1 must include the following topics:

 

9.2a Summary of work completed.

 

9.2b Key scientific discoveries.

 

9.2c Summary of work in progress.

 

9.2d Current schedule of anticipated events or milestones.

 

9.2e Market plans for introduction of Licensed Products.

 

9.2f A summary of resources ( dollar value) spent in the reporting period.

 

9.3. Licensee must notify The Regents if Licensee or any of its Sublicensees or Affiliates ceases to be a small entity (as defined by the United States Patent and Trademark Office) under the provisions of 35 U.S.C. §41(h).

 

9.4 Licensee must report the date of the First Commercial Sale in the royalty report immediately following that Sale.

 

 

9.5 After the First Commercial Sale of each Licensed Product, Licensee must make quarterly royalty reports to The Regents by February 28, May 31, August 31 and November 30 of each year (i.e., within two months from the end of each calendar quarter). Each royalty report must cover Licensee's most recently completed calendar quarter and must show:

 

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9.5a Gross sales and Net Sales of any Licensed Product.

 

9.5b Number of each type of Licensed Product sold.

 

9.5c Royalties payable to The Regents.

 

9.6 Licensee must state in its royalty report if it had no sales of any Licensed Product.

 

10. BOOKS AND RECORDS

 

10.1 Licensee must keep accurate books and records of all Licensed Products manufactured, used or sold. Licensee must preserve these books and records for at least five years from the date of the royalty payment to which they pertain.

 

 

 

10.2 The Regents' representatives or agents are entitled to inspect these books and records at reasonable times. The Regents will pay the fees and expenses of these inspections. If an error · favoring Licensee of more than 5% of the total annual royalties is discovered, then Licensee will pay the fees and expenses of these inspections.

 

11. LIFE OF THE AGREEMENT

 

11.1 Unless otherwise terminated by operation of law or by acts of the parties in accordance with the terms of this Agreement, this Agreement is in force from the Effective Date recited on page one and remains in effect for the life of the last-to-expire patent in Regents' Patent Rights, or until the last patent application licensed under this Agreement is abandoned and no patent in Regents' Patent Rights ever issues.

 

11.2 Upon termination of this Agreement, Licensee will have no further right to make, have made, use or sell any Licensed Product except as provided in Article 14 (Disposition of Licensed Products on Hand Upon Termination).

 

11.3 Any expiration or termination of this Agreement will not affect the rights and obligations set forth in the following Articles:

 

Article 10

Article 14

Article 16

Article 17

Article 18

Article 23

Article 24

Books and Records

Disposition of Licensed Products on Hand upon Termination.

Use of Names and Trademarks.

Warranties

Indemnification.

Failure to Perform.

Governing Law

 

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12. TERMINATION BY THE REGENTS

 

12.1 If Licensee violates or fails to perform any material term or covenant of this Agreement, then The Regents may give written notice of the default ("Notice of Default") to Licensee. If Licensee does not repair the default within 60 days after the effective date of the Notice of Default, then The Regents has the right to terminate this Agreement and the License by a second written notice ("Notice of Termination") to Licensee. If The Regents sends a Notice of Termination to Licensee, then this Agreement automatically terminates on the effective date of this notice. Termination does not relieve Licensee of its obligation to pay any royalty or fees owing at the time of termination and does not impair any accrued right of The Regents.

 

13. TERMINATION BY LICENSEE

 

13.1 Licensee has the right at any time to terminate this Agreement in whole or with respect to any portion of Regents' Patent Rights by giving written notice to The Regents. This notice of termination will be subject to Article 19 (Notices) and will be effective 90 days after the effective date of the notice.

  

13.2 Any termination in accordance with Paragraph 13.1 does not relieve Licensee of any obligation or liability accrued prior to termination. Nor does termination rescind anything done by Licensee or any payments made to The Regents prior to the effective date of termination. Termination does not affect in any manner any rights of The Regents arising under this Agreement prior to termination.

 

14. DISPOSITION OF LICENSED PRODUCTS ON HAND UPON TERMINATION

 

14.1 Upon termination of this Agreement, Licensee will have the right to dispose of all previously made or partially made Licensed Products, but no more, within a period of six months. But Licensee must submit royalty reports on the sale of these Licensed Products and must pay royalties at the rate and at the time provided in this Agreement.

 

15. PATENTMARKING

 

15.1 Licensee must mark all Licensed Products made, used or sold under the terms of this Agreement, or their containers, in accordance with the applicable patent marking laws.

 

16. USE OF NAMES AND TRADEMARKS

 

16.1 Neither party is permitted to use any name, trade name, trademark or other designation of the other party or its employees (including contraction, abbreviation or simulation of any of the foregoing) in advertising, publicity or other promotional activity. Unless required by law, Licensee is expressly prohibited from using the name "The Regents of the University of California" or the name of any campus of the University of California.

 

17. LIMITED WARRANTY

 

17.1 The Regents warrants that it has the lawful right to grant this license to Licensee.

 

17.2 This License and the associated Invention are provided WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. THE REGENTS MAKE NO REPRESENTATION OR WARRANTY THAT ANY LICENSED PRODUCT WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.

 

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17.3 IN NO EVENT WILL THE REGENTS BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM EXERCISE OF THIS LICENSE OR THE USE OF THE INVENTION OR LICENSED PRODUCTS OR THE USE OR THE PRACTICE OF LICENSED METHODS.

 

17.4 Nothing in this Agreement will be construed as:

 

17.4a A warranty or representation by The Regents as to the validity or scope of any Regents' Patent Rights.

 

17.4b A warranty or representation that anything made, used, sold or otherwise disposed of under any license granted in this Agreement is or will be free from infringement of patents of third parties.

 

17.4c Obligate The Regents to bring or prosecute actions or suits against third parties for patent infringement except as provided in Article 8 (Patent Infringement).

 

17.4d Conferring by implication, estoppel or otherwise any license or rights under any patents of The Regents other than Regents' Patent Rights as defined herein, regardless of whether such patents are dominant or subordinate to Regents' Patent Rights.

 

17.4e Obligate The Regents to furnish any know-how not provided in Regents' Patent Rights.

 

18. INDEMNIFICATION

 

18.1 Licensee will, and will require its Sublicensees to, indemnify, hold harmless and defend The Regents, its officers, employees, and agents, the sponsors of the research that led to the invention, the inventors of the patents and patent applications in Regents' Patent Rights and their respective employers from and against any and all liability, claims, suits, losses, damages, costs, fees and expenses resulting from or arising out of exercise of this license or any sublicense. Indemnification indudes but is not limited to products liability. If The Regents, in its sole discretion, believes that there will be a conflict of interest or it will not otherwise be adequately represented by counsel chosen by Licensee to defend The Regents in accordance with this Paragraph 18.1, then The Regents may retain counsel of its choice to represent it, and Licensee will pay all expenses for such representation.

 

18.2 For the first use of the Licensed Product for humans and thereafter, Licensee, at its sole cost and expense, must insure its activities in connection with the work under this Agreement and obtain, keep in force and maintain Comprehensive or Commercial Form General Liability Insurance (contractual liability included) with limits as follows:

 

18.2a Each occurrence $5,000,000

18.2b Products/completed operations aggregate $10,000,000

18.2c Personal and advertising injury $5,000,000

18.2d General aggregate (commercial form only) $10,000,000

 

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18.3 Licensee expressly understands, however, that the coverages and limits in Paragraph 18.2 do not in any way limit the Licensee's liability. Licensee must furnish The Regents with certificates of insurance evidencing compliance with all requirements. Licensee's insurance must:

 

18.3a Provide for 30-day advance written notice to The Regents of any modification.

18.3b Indicate that The Regents of the University of California is endorsed as an Insured under the coverages listed in Paragraph 18.2.

18.3c Include a provision that the coverages will be primary and will not participate with nor will be excess over any valid and collective insurance or program of self-insurance carried or maintained by The Regents.

 

18.4 The Regents shall notify Licensee in writing of any claim or suit brought against The Regents in respect of which The Regents intends to invoke the provisions of this Article 18 (Indemnification). Licensee shall keep The Regents informed on a current basis of its defense of any claims under this Article 18 (Indemnification).

 

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19. NOTICES

 

19.1 Any notice or payment required to be given to either party must be sent to the respective address given below and is effective: (a) on the date of delivery if delivered in person, (b) five days after mailing if mailed by first-class certified mail, postage paid, or ( c) on the next business day if sent by overnight delivery. Either party may change its designated address by written notice.

 

  For Licensee: GENERAL FIBER, INC.
    801 Brickell Avenue 9th  Floor Suite 942
    Miami, Florida
    Attention: Nicholas Stergis
     
  For The Regents: The Regents of the University of California University of California, Los Angeles Office of Intellectual Property Administration 10920 Wilshire Blvd., Suite 1200 Los Angeles, California 90095-1406
    Attention: Director

 

20. ASSIGNABILITY

 

20.1 This Agreement is binding upon and inures to the benefit of The Regents, its successors and assigns. But it is personal to Licensee and assignable by Licensee only with the written consent of The Regents. The consent of The Regents will not be required if the assignment is in conjunction with the transfer of all or substantially all of the business of Licensee to which this license relates.

 

21. LATE PAYMENTS

 

21.1 For each royalty payment or fee not received by The Regents when due, Licensee must pay to The Regents a simple interest charge of 10% per annum to be calculated from the date payment was due until it was actually received by The Regents.

 

22. WAIVER

 

22.1 The waiver of any breach of any term of this Agreement does not waive any other breach of that or any other term.

 

23. FAILURE TO PERFORM

 

23.1 If either party takes legal action against the other because of a failure of performance due under this Agreement, then the prevailing party is entitled to reasonable attorney's fees in addition to costs and necessary disbursements.

 

24. GOVERNING LAW

 

24.1 THIS AGREEMENT IS TO BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF CALIFORNIA, but the scope and validity of any patent or patent application will be governed by the applicable laws of the country of the patent or patent application.

 

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25. GOVERNMENT APPROVAL OR REGISTRATION

 

25.1 If this Agreement or any associated transaction is required by the law of any nation to be either approved or registered with any governmental agency, Licensee will assume all legal obligations to do so. Licensee will notify The Regents if it becomes aware that this Agreement is subject to a United States or foreign government reporting or approval requirement. Licensee will make all necessary filings and pay all costs including fees, penalties, and all other out-of-pocket costs associated with such reporting or approval process.

 

26. EXPORT CONTROL LAWS

 

26.1 Licensee must observe all applicable United States and foreign laws with respect to the transfer of Licensed Products and related technical data to foreign countries, including the International Traffic in Arms Regulations (IT AR) and the Export Administration Regulations.

 

27. PREFERENCE FOR UNITED STATES INDUSTRY

 

27.1 Because this Agreement grants an exclusive right to a particular use of the Invention, Licensee must manufacture in the United States any products embodying this Invention or produced through the Invention's use to the extent required by 35 U.S.C. §200-212.

 

28. FORCE MAJEURE

 

28.1 The parties will be excused from any performance required under this Agreement if performance is impossible or unfeasible due to any catastrophe or other major event beyond their reasonable control, including war, riot, or insurrection; lockouts or other serious labor disputes; and floods, fires, explosions, or other natural disasters. When such events abate, and in any event within one year, the parties' respective obligations will resume.

 

29. CONFIDENTIALITY

 

29.1 If either party discloses confidential information to the other party, the disclosing party will designate this information as confidential by appropriate legend or instruction, and the receiving party will:

 

29.1a Use the same degree of care to maintain the secrecy of the confidential information as it uses to maintain the secrecy of its own information of like kind.

 

29.1 b Use the confidential information only to accomplish the purposes of this Agreement.

 

29.2 Neither party will disclose confidential information received from the other party except to its employees, customers, distributors and other agents who are bound to it by similar obligations of confidence and only as required to accomplish the purposes of this Agreement.

 

29.3 Neither party will have any confidentiality obligation with respect to the confidential information belonging to or disclosed by the other party that:

 

29.3a The receiving party can demonstrate by written records was previously known to it.

 

29.3b The receiving party lawfully obtained from sources under no obligation of confidentiality.

 

14
 

 

29.3c Is or becomes publicly available other than through an act or omission of the receiving party or any of its employees.

 

29.3d Is required to be disclosed under the California Public Records Act, governmental audit requirement or other requirement of law.

 

29.4 The provisions of this Article 29 will continue III effect for five years after expiration or termination of this Agreement.

 

29.5 The Regents is free to release to the inventors and senior administrators employed by The Regents the terms and conditions of this Agreement. If such release is made, then The Regents shall give notice of the confidential nature and shall request that the recipient not disclose such terms and conditions to others. If a third party inquires whether a license to Regents' Patent Rights is available, then The Regents may disclose the existence of this Agreement and the extent of the grant in Article 2 (Grant) to such third party, but will not disclose the name of Licensee or any other terms or conditions of this Agreement, except where The Regents is required to release information under the California Public Records Act, a governmental audit requirement, or other applicable law.

 

30. MISCELLANEOUS

 

30.1 The headings of the several sections are inserted for convenience of reference only and are not intended to be a part of, or to affect the meaning or interpretation of, this Agreement.

 

30.2 This Agreement is not binding upon the parties until it has been signed below on behalf of each party, in which event it becomes effective as of the date recited on page one.

 

30.3 No amendment or modification of this Agreement will be valid or binding upon the parties unless made in writing and signed by each party.

 

30.4 This Agreement embodies the entire understanding of the parties and supersedes all previous communications, representations or understandings, either oral or written, between the parties relating to the subject matter hereof, except for the Secrecy Agreement dated 10-20-03, which continues to the extent it is not inconsistent with this Agreement.

 

30.5 If any part of this Agreement is for any reason found to be unenforceable, all other parts nevertheless remain enforceable as long as a party's rights under this Agreement are not materially affected. In lieu of the unenforceable provision, the parties will substitute or add as part of this Agreement a provision that will be as similar as possible in economic and business objectives as was intended by the unenforceable provision.

 

Both The Regents and Licensee have executed this Agreement in duplicate originals by their authorized officers on the dates written below:

 

GENERAL FIBER, INC THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
   
By: /s/ Nicholas Stergis By: /s/ Emily Loughran
Name: Nicholas Stergis Name: Emily Loughran
Title: Chief Operating Officer Title: Director of Licensing
   
Dated: July 11, 2005 Dated: July 5, 2005

 

15
 

 

APPENDIX A

 

REGENTS’ PATENT RIGHTS

 

U.S. Patent Application No. 10/131,384 entitled “Estriol Therapy for Multiple Sclerosis and Other Autoimmune Diseases,” filed April 24, 2002, which was based on Provisional ApplicationNo. 60/286,842 filed 4/25/01 (UCLA Case Nos 1998-531-1,2) by Dr. Voskuhl, and assigned to The Regents.

 

U.S. Patent Application No. 10/984,364 entitled “The Use of Estrial and Other Estranes, Estrogen and Estrogen Receptor Active Compositions in the Treatment of Psoriasis…,” filed November 8, 2004, (UCLA Case No. 2004-101-3) by Drs. Rhonda R. Voskuhl, Gerald D. Weinstein and Jenny E. Murase and assigned to The Regents.

 

European Patent Application No. 02729034.5 based on PCT/US02/13407, filed April 25, 2002 entitled “Estriol Therapy for Multiple Sclerosis and Other Autoimmune Diseases” by Dr. Rhonda R. Voskuhl.

 

16
 

  

EXCLUSIVE LICENSE AGREEMENT

 

TABLE OF CONTENTS

 

  ARTICLE PAGE NUMBER 
RECITALS 1
   
1. DEFINITIONS 1
   
2. GRANT 3
   
3. SUBLICENSES 3
   
4. FEES 4
   
5. ROYALTIES 4
   
6. DILIGENCE 5
   
7. PATENT FILING, PROSECUTION AND MAINTENANCE 6
   
8. PATENT INFRINGEMENT 7
   
9. PROGRESS AND ROYALTY REPORTS 8
   
10. BOOKS AND RECORDS 9
   
11. LIFE OF THE AGREEMENT 9
   
12. TERMINATION BY THE REGENTS 10
   
13. TERMINATION BY LICENSEE 10
   
14. DISPOSITION OF LICENSED PRODUCTS ON HAND UPON TERMINATION 10
   
15. PATENT MARKING 10
   
16. USE OF NAMES AND TRADEMARKS 10
   
17. LIMITED WARRANTY 10
   
18. INDEMNIFICATION 11
   
19. NOTICES 12
   
20. ASSIGNABILITY 12
   
21. LATE PAYMENTS 13
   
22. WAIVER 13
   
23. FAILURE TO PERFORM 13
   
24. GOVERNING LAWS 13
   
25. GOVERNMENT APPROVAL OR REGISTRATION 13
   
26. EXPORT CONTROL LAWS 13
   
27. PREFERENCE FOR UNITED STATES INDUSTRY 13
   
28. FORCE MAJEURE 13
   
29. CONFIDENTIALITY 14
   
30. MISCELLANEOUS 14
   
APPENDIX A  

 

17

 

 EX-10.46 3 v337358_ex10-46.htm EXHIBIT 10.46

 

Exhibit 10.46

 

First Amendment to the License Agreement Between The Regents of the University of California and
General Fiber, Inc. UC Agreement Control No. 2006-04-0026

 

This First Amendment ("First Amendment"), dated November 08, 2005 (the "Effective Date"), is made by and between The Regents of the University of California ("The Regents") and General Fiber, Inc. ("Licensee").

 

RECITALS

 

WHEREAS, The Regents has entered into an existing Exclusive License Agreement with Licensee, dated July 11, 2005, relating to various inventions entitled, "Estriol for the treatment of autoimmune diseases & the use of estriol and other estranges, estrogens and estrogen receptor active compositions in the treatment of psoriasis & other autoimmune diseases" (UCLA Case No. 1998-531 & UCLA Case No. 2004-101) developed at The Regents (the "License Agreement");

 

WHEREAS, Licensee desires to amend and clarify the License Agreement with The Regents;

 

NOW THEREFORE, in consideration of the foregoing premises and the mutual promises, covenants, and agreements hereinafter set forth, all parties to this First Amendment mutually agree to amend the License Agreement as follows:

 

1. Paraqraph 1.1 ("Regents' Patent Rights") is deleted and replaced with the following, which is amended to include "UC Case No. 2006-154" and UC Case No. 2006-155" in the parenthetical in the paragraph:

 

1.1 "Regents' Patent Rights" means The Regents interest in any of the patent applications listed in Appendix A attached to this Agreement and assigned to The Regents (UCLA Case No. 1998-531, UCLA Case No. 2004-101, UCLA Case No. 2006.. 154 and UCLA Case No. 2006-155); any continuing applications thereof including divisions; but excluding continuations-in-part except to the extent of claims entirel'y supported in the specification and entitled to the priority date of the parent application; any patents issuing on these applications including reissues and reexaminations; and any corresponding foreign patents or patent applications; all of which will be automatically incorporated in and added to Appendix A and made a part of this Agreement.

 

2. Appendix A ("Regents' Patent Rights") is deleted and replaced with the following, which is amended to include the patent applications filed under UC Case No. 2006-154 and UC Case No. 2006-155.

 

APPENDIX A REGENTS' PATENT RIGHTS

 

                        Patent No. 6,936,599, which was based on U.S. Patent Application No. 10/131,834 entitled "Estriol Therapy for Multiple Sclerosis and Other Autoimmune Diseases," Wed April 24, 2002, which was based on Provisional Application No. 60/286,842 filed 4125/01 (UCLA Case Nos. 1998-531-1,2) by Dr. Rhonda

 

                        Voskuhl, and assigned to The Regents.

 

                        S. Patent Application No. 10/984,364 entitled "The Use of Estriol and Other Estranes, Estrogen and Estrogen Receptor Active Compositions in the Treatment of Psoriasis ... ," filed November 8,2004, (UCLA Case No. 2004-101-3) by Drs. Rhonda R. Voskuhl, Gerald D. Weinstein and Jenny E. Murase and assigned to The Regents.

 

 
 

 

European Patent Application No. 02729034.5 based on PCT/US02/13407 (UCLA Case No. 1998-531-2), filed April 25, 2002 entitled "Estriol Therapy for Multiple Sclerosis and Other Autoimmune Diseases" by Dr. Rhonda R. Voskuhl.

 

Provisional Patent Application entitled "Method of treating post-partum diseases with estrogens, estranges, estriol, or estrogen receptor composition", filed September 26, 2005 (UCLA Case No.2006154), invented by Dr. Rhonda Voskuhl and assigned to The Regents.

 

Provisional Patent Application entitled "Method of treating of preventing a neurodegenerative disease with estrogens, estranges, estriol, or estrogen receptor composition", filed September 26, 2005 (UCLA ~ase No.2006-155), invented by Dr. Rhonda Voskuhl and assigned to The Regents.

 

3. Section 6.3

 

Under Section 6.3 of the License Agreement, the list of diligence items shall be expanded to include the following:

 

Section 6.3e: Licensee will, within eighteen months from the Effective Date of this Amendment, conduct preclinical or clinical studies with one or more of the compounds whQse utility is claimed in the patent application described in Appendix A above to test efficacy in at least one disease other than multiple sclerosis,.

 

The remainder of the due diligence obligations shall remain in place for the patent applications under Appendix A.

 

4. In consideration for this Amendment, Licensee will pay to The Regents a two thousand dollar ($2,000) amendment fee within thirty (30) days of the Effective Date of this First Amendment.

 

IN WITNESS WHEREOF, the parties have executed this First Amendment to the License Agreement by their duly authorized representatives for good and valuable consideration.

 

GENERAL FIBER, INC THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
   
By: /s/ Nicholas Stergis By: /s/ Claire T . Wake, Ph.D.
Name: Nicholas Stergis Name: Claire T . Wake, Ph.D.
Title: Chief Operating Officer Title: Assistant Director, Licensing
  Office of Intellectual Property Administration

 

2

 

 

 EX-10.47 4 v337358_ex10-47.htm EXHIBIT 10.47

 

Exhibit 10.47

 

Second Amendment to the License Agreement Between the Regents of the University of California and
General Fiber, Inc. License Agreement Control No. 2006-04-0026 Effective January 3, 2007

 

This Second Amendment (the “Second Amendment”) dated January 3, 2007 is made by and between The Regents of the University of California and General Fiber, Inc.

 

RECITALS

 

WHEREAS, The Regents has entered into an Exclusive License with dated July 11, 2005, and a First Amendment to the License November 8. 2005 to various inventions entitled, "Estriol for the treatment of autoimmune diseases & the use of estnol and other and f'ci-rr.rrpn actlVe in the treatment of & other autoimmune diseases" 1998-531 & UCLA Case No. 2004-1 at The Regents (the "License Agreement’)

 

WHEREAS, Licensee desires to amend and the License with The

 

NOW THEREFORE, in consideration of the foregoing premises and the mutual promises, covenants, and agreements hereinafter set forth, all parties to this Second Amendment mutually agree to amend the License Agreement as follows:

 

1  In Paragraph 1.1 ("Regents' Patent Rights"), any reference to "UC Case No. 2004101-3" 1S amended to exclude this case number (UC Case No. 2004-JOl-3). The remainder of the case numbers shall remain as part of the license.

 

2  Appendix A Patent is hereby amended to remove any reference to UC Case No. 2004-101 and LLS. Patent Application No.1 entitled. "The Use of Estriol and Other Estranes. Estrogen and Estrogen Active Compositions in the treatment of Psoriasis:, filed November 8, 2004, invented by Drs. Rhonda Voskuhl, Gerald D. Weinstein and Jenny E. Murase and to the

 

The remainder of the patents listed on A will remain of the license.

 

3. Under Section 6.3 of the License Agreement, section 6.3e shall be deleted.

 

4. In consideration for this Second Amendment, Licensee will pay to the a two thousand dollar ($2,000) amendment fee within thirty (30) of the Effective Date of this amendment.

 

IN WITNESS WHEREOF, the parties have executed this Second Amendment to the License by their duly authorized for and valuable consideration.

 

 

GENERAL FIBER, INC.   THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
   
By: /s/ Nicholas Stergis             By: /s/ Emily W. Loughran             
Name: Nicholas Stergis Name: Emily W. Loughran
Title: Chief Operating Officer Title: Director of Licensing

 

 

 

 

 EX-10.48 5 v337358_ex10-48.htm EXHIBIT 10.48

 

Exhibit 10.48

 

THIRD AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT

 

UC Agreement Control No. 2006-04-0026

 

This third amendment ("Third Amendment") to the Exclusive License Agreement ("Agreement"), effective August 29, 2007 is made by and between The Regents of the University of California, a California corporation ("The Regents"), and Putney Drug Corp, a Delaware company ("Licensee").

 

BACKGROUND

 

  A. The Regents and Licensee are parties to the Agreement, dated as of July II, 2005.
  B. The Agreement was amended on November 8, 2005 ("First Amendment") and on January 3, 2007 ("Second Amendment");

 

The parties agree as follows:

 

I. Amend Paragraph I.l ("Regents' Patent Rights") to include UC Case No. 2007

 

561.

 

2. In consideration for adding UC Case No. 2007-561 to the Agreement, a milestone payment in the new Paragraph 4.5, which reads as follows, is added to the Agreement:

 

4.5 Licensee will pay The Regents, in either cash or publicly traded equity, twenty thousand dollars ($20,000) upon issuance of the first US patent claiming priority to the provisional filing (SN 60/933,030).

 

IN WITNESS WHEREOF, the parties have executed this Third Amendment to the Agreement by their duly authorized representatives for good and valuable consideration.

 

PUTNEY DRUG CORP. THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
   
By: /s/ Steve Kanzer             By: /s/ Emily Waldron Loughran             
Name: Steve Kanzer Name: Emily Waldron Loughran
Title: President Title: Director of Licensing
   
Dated: August 30, 2007 Dated: September 4, 2007

 

 

 

 EX-10.49 6 v337358_ex10-49.htm EXHIBIT 10.49

 

Exhibit 10.49

 

FOURTH AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT

UC Agreement Control No. 2006-04-0026

 

This fourth amendment (“Fourth Amendment”) to the Exclusive License Agreement (“Agreement”), effective December 31, 2012 is made by and between the Regents of the University of California, a California corporation (“The Regents”), and Putney Drug Corp., a Delaware company (“Licensee”).

 

BACKGROUND

 

A.The Regents and Licensee are parties to the Agreement, dated as of July 11, 2005.

 

B.The Agreement was amended on November 8, 2005 (“First Amendment”), on January 3, 2007 (“Second Amendment”) and on August 29, 2007 (“Third Amendment”);

 

The parties agree as follows:

 

1.Amend paragraph 1.4 to read as follows: “1.4 The ‘Field of Use’ means human therapeutics for the treatment of autoimmune diseases, including multiple sclerosis.”

 

2.Amend paragraph 4.3 to increase the annual maintenance fee from “$5,000” to “$10,000”.

 

3.Amend paragraph 4.2 by adding a new subparagraph 4.2c to read “seven hundred fifty thousand dollars ($750,000) upon the first achievement of fifty million dollars ($50,000,000) in annual sales while covered by a validly issued U.S. patent.”

 

4.Amend paragraph 6.3c to replace “Within eight years of the Effective Date of this Agreement, initiate Phase III clinical trials” with “Within 3 years from the successful completion of the ongoing clinical trial of estriol for relapsing-remitting multiple sclerosis being conducted by Dr. Rhonda Voskuhl as principal investigator, initiate a Phase III clinical Trial”.

 

5.Amend paragraph 6.3d to replace “fourteen (14) years” with “seventeen (17) years”.

 

IN WITNESS WHEREOF, the parties have executed this Fourth Amendment to the Agreement by their duly authorized representatives for good and valuable consideration.

 

PUTNEY DRUG CORP.   THE REGENTS OF THE UNIVERSITY OF
      CALIFORNIA
         
By: /s/ Jeff Riley   By: /s/ Emily Waldron Loughran
  (signature)     (signature)
Name:  Jeff Riley   Name:  Emily Waldron Loughran
Title: CEO   Title: Director of Licensing
Date: 3/15/2013   Date: 3/25/2013

 

 

 

 EX-23.1 7 v337358_ex23-1.htm EXHIBIT 23.1

 

Exhibit 23.1

 

Consent of Independent Registered Public Accounting Firm

 

Synthetic Biologics, Inc.

Rockville, MD

 

We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (No. 333-166750 and 333-156973) and Form S-8 (No. and 333-170858 and 333-148764) of Synthetic Biologics, Inc. of our report dated April 16, 2013, relating to the 2012 consolidated financial statements, which appear in this Form 10-K.

 

/s/ BDO USA, LLP

 

BDO USA, LLP

Boston, MA

April 16, 2013

 

 

 

 EX-23.2 8 v337358_ex23-2.htm EXHIBIT 23.2

 

Exhibit 23.2

 

  

Consent of Independent Registered Public Accounting Firm

 

We consent to the use of our report dated May 11, 2012 on the financial statements of Synthetic Biologics, Inc. as of December 31, 2011, and the related statements of operations, stockholders’ equity and cash flows for the year ended December 31, 2011, included herein on the registration statement of Synthetic Biologics, Inc. on Forms S-3 and S-8, referenced herein.

 

(i)Registration Statement (Form S-8, No. 333-170858), which relates to the Registrant’s 2010 Stock Incentive Plan.

 

(ii)Registration Statement (Form S-8, No. 333-148764), which relates to the Registrant’s 2001 Stock Incentive Plan and 2007 Stock Incentive Plan.

 

(iii)Registration Statement (Form S-3, No. 333-166750), which relates to an indeterminate amount of securities of the Registrant pursuant to which the Registrant has issued,

 

(iv)Registration Statement (Form S-3, No. 333-156973), which relates to the registration of 9,965,671 shares of common stock on behalf of selling stockholders.

 

 

Berman & Company, P.A.

Certified Public Accountants

 

 

Boca Raton, Florida

April 16, 2013

 

 

 

 

 EX-31.1 9 v337358_ex31-1.htm EXHIBIT 31.1

 

EXHIBIT 31.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO RULE 13a-14 OR RULE 15d-14 OF THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Jeffrey Riley, certify that:

 

1.I have reviewed this annual report on Form 10-K of Synthetic Biologics, Inc.;

 

2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

  

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: April 16, 2013 By: /s/ Jeffrey Riley
    Name: Jeffrey Riley
    Title: Chief Executive Officer
    (Principal Executive Officer)

 

 

 
 EX-31.2 10 v337358_ex31-2.htm EXHIBIT 31.2

 

EXHIBIT 31.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

PURSUANT TO RULE 13a-14 OR RULE 15d-14 OF THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, C. Evan Ballantyne, certify that:

 

1.I have reviewed this annual report on Form 10-K of Synthetic Biologics, Inc.;

 

2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

  

5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: April 16, 2013 By: /s/ C. Evan Ballantyne
    Name: C. Evan Ballantyne
    Title: Chief Financial Officer
    (Principal Financial Officer)

  

 
 EX-32.1 11 v337358_ex32-1.htm EXHIBIT 32.1

 

EXHIBIT 32.1

 

CERTIFICATION PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Synthetic Biologics, Inc. (the “Registrant”) hereby certifies, to such officer’s knowledge, that:

 

(1)the accompanying Annual Report on Form 10-K of the Registrant for the year ended December 31, 2012 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

(2)the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.

 

Date: April 16, 2013  
     
  By: /s/ Jeffrey Riley
    Name: Jeffrey Riley
    Title: Chief Executive Officer
    (Principal Executive Officer)

  

 
 EX-32.2 12 v337358_ex32-2.htm EXHIBIT 32.2

 

EXHIBIT 32.2

 

CERTIFICATION PRINCIPAL FINANCIAL OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Synthetic Biologics, Inc. (the “Registrant”) hereby certifies, to such officer’s knowledge, that:

 

(1)the accompanying Annual Report on Form 10-K of the Registrant for the year ended December 31, 2012 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

(2)the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.

 

Date: April 16, 2013  
     
  By: /s/ C. Evan Ballantyne
    Name: C. Evan Ballantyne
    Title: Chief Financial Officer
    (Principal Financial Officer)

 

 

 

 

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    Stock-Based Compensation (Details 2) (USD $)
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Dec. 31, 2010
    Options Outstanding, Options 4,453,746 2,979,010 2,539,091
    Options Outstanding, Weighted Average Exercise Price $ 1.78 $ 1.34 $ 1.32
    Options Outstanding, Weighted Average Remaining Contractual Life 6 years 5 months 5 days 6 years 0 months 4 days 6 years 11 months 19 days
    Options Exercisable, options 2,891,877    
    Options Exercisable, Weighted Average Exercise Price $ 1.60    
    Options Exercisable, Weighted Average Remaining Contractual Life 5 years 8 months 16 days    
    Range Of Exercise Price 0.09-2.00 [Member]
    		      
    Options Outstanding, Options 2,162,362    
    Options Outstanding, Weighted Average Exercise Price $ 1.78    
    Options Outstanding, Weighted Average Remaining Contractual Life 5 years 9 months 4 days    
    Options Exercisable, options 1,801,187    
    Options Exercisable, Weighted Average Exercise Price $ 1.14    
    Options Exercisable, Weighted Average Remaining Contractual Life 5 years 6 months 7 days    
    Range Of Exercise Price 0.09-2.00 [Member] | Maximum [Member]
    		      
    Range of Exercise Price $ 2.00    
    Range Of Exercise Price 0.09-2.00 [Member] | Minimum [Member]
    		      
    Range of Exercise Price $ 0.09    
    Range Of Exercise Price 2.01-3.00 [Member]
    		      
    Options Outstanding, Options 2,212,227    
    Options Outstanding, Weighted Average Exercise Price $ 2.26    
    Options Outstanding, Weighted Average Remaining Contractual Life 7 years 1 month 24 days    
    Options Exercisable, options 1,011,533    
    Options Exercisable, Weighted Average Exercise Price $ 2.17    
    Options Exercisable, Weighted Average Remaining Contractual Life 6 years 1 month 20 days    
    Range Of Exercise Price 2.01-3.00 [Member] | Maximum [Member]
    		      
    Range of Exercise Price $ 3.00    
    Range Of Exercise Price 2.01-3.00 [Member] | Minimum [Member]
    		      
    Range of Exercise Price $ 2.01    
    Range Of Exercise Price 3.01- 6.00 [Member]
    		      
    Options Outstanding, Options 79,157    
    Options Outstanding, Weighted Average Exercise Price $ 4.87    
    Options Outstanding, Weighted Average Remaining Contractual Life 4 years 5 months 26 days    
    Options Exercisable, options 79,157    
    Options Exercisable, Weighted Average Exercise Price $ 4.87    
    Options Exercisable, Weighted Average Remaining Contractual Life 4 years 5 months 26 days    
    Range Of Exercise Price 3.01- 6.00 [Member] | Maximum [Member]
    		      
    Range of Exercise Price $ 6.00    
    Range Of Exercise Price 3.01- 6.00 [Member] | Minimum [Member]
    		      
    Range of Exercise Price $ 3.01    
    Range Of Exercise Price 0.09-6.00 [Member]
    		      
    Options Outstanding, Options 4,453,746    
    Options Outstanding, Weighted Average Exercise Price $ 1.78    
    Options Outstanding, Weighted Average Remaining Contractual Life 6 years 5 months 5 days    
    Options Exercisable, options 2,891,877    
    Options Exercisable, Weighted Average Exercise Price $ 1.60    
    Options Exercisable, Weighted Average Remaining Contractual Life 5 years 8 months 16 days    
    Range Of Exercise Price 0.09-6.00 [Member] | Maximum [Member]
    		      
    Range of Exercise Price $ 6.00    
    Range Of Exercise Price 0.09-6.00 [Member] | Minimum [Member]
    		      
    Range of Exercise Price $ 0.09    
    Range Of Exercise Price 0.09-4.57 [Member]
    		      
    Options Outstanding, Options   2,889,011  
    Options Outstanding, Weighted Average Exercise Price   $ 1.20  
    Options Outstanding, Weighted Average Remaining Contractual Life   6 years 1 month 10 days  
    Options Exercisable, options   2,364,608  
    Options Exercisable, Weighted Average Exercise Price   $ 1.29  
    Options Exercisable, Weighted Average Remaining Contractual Life   5 years 8 months 19 days  
    Range Of Exercise Price 0.09-4.57 [Member] | Maximum [Member]
    		      
    Range of Exercise Price   $ 4.57  
    Range Of Exercise Price 0.09-4.57 [Member] | Minimum [Member]
    		      
    Range of Exercise Price   $ 0.09  
    Range Of Exercise Price 4.58-9.05 [Member]
    		      
    Options Outstanding, Options   89,999  
    Options Outstanding, Weighted Average Exercise Price   $ 5.93  
    Options Outstanding, Weighted Average Remaining Contractual Life   2 years 9 months 4 days  
    Options Exercisable, options   89,999  
    Options Exercisable, Weighted Average Exercise Price   $ 5.93  
    Options Exercisable, Weighted Average Remaining Contractual Life   2 years 9 months 4 days  
    Range Of Exercise Price 4.58-9.05 [Member] | Maximum [Member]
    		      
    Range of Exercise Price   $ 9.05  
    Range Of Exercise Price 4.58-9.05 [Member] | Minimum [Member]
    		      
    Range of Exercise Price   $ 4.58  
    Range Of Exercise Price 0.09-9.05 [Member]
    		      
    Options Outstanding, Options   2,979,010  
    Options Outstanding, Weighted Average Exercise Price   $ 1.34  
    Options Outstanding, Weighted Average Remaining Contractual Life   6 years 0 months 4 days  
    Options Exercisable, options   2,454,607  
    Options Exercisable, Weighted Average Exercise Price   $ 1.46  
    Options Exercisable, Weighted Average Remaining Contractual Life   5 years 7 months 13 days  
    Range Of Exercise Price 0.09-9.05 [Member] | Maximum [Member]
    		      
    Range of Exercise Price   $ 9.05  
    Range Of Exercise Price 0.09-9.05 [Member] | Minimum [Member]
    		      
    Range of Exercise Price   $ 0.09  

    XML 29 R54.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Related Party Transactions (Details Textual) (USD $)
    		 12 Months Ended 12 Months Ended 1 Months Ended 9 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Aug. 31, 2012
    Intrexon [Member]
    Nov. 30, 2011
    Intrexon [Member]
    Dec. 31, 2012
    Intrexon [Member]
    Research and Development Expense [Member]
    Oct. 31, 2012
    Mr Kanzer [Member]
    Dec. 31, 2012
    Mr Kanzer [Member]
    Employment Agreement Descrption           Mr. Kanzer entered into a two year agreement with us on a part time basis (2.5 days per week). Mr. Kanzer entered into a six month employment agreement with us on a full time basis (the "Kanzer Employment Agreement"), which may be extended for an additional three (3) months upon consent of the parties.
    Noninterest Expense Directors Fees           $ 150,000 $ 90,000
    Common stock, shares, issued 44,444,230 31,374,002 3,552,210 3,123,558      
    Common stock, $0.001 par value; 100,000,000 shares authorized, 44,444,230 issued and 44,362,748 outstanding and 31,374,002 issued and 31,292,520 outstanding 44,000 31,000 7,800,000 1,700,000      
    Common stock, par value (in dollars per share) $ 0.001 $ 0.001 $ 2.2 $ 0.54      
    Costs and Expenses, Related Party $ 2,900,000       $ 2,500,000    
    XML 30 R48.htm IDEA: XBRL DOCUMENT v2.4.0.6
    License, Collaborative and Employment Agreements and Commitments (Details) (USD $)
    In Thousands, unless otherwise specified
    Dec. 31, 2012
    2013 $ 287
    2014 60
    2015 35
    2016 10
    2017 10
    Total $ 402
    XML 31 R46.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Stock-Based Compensation (Details Textual) (USD $)
    		 0 Months Ended 1 Months Ended 12 Months Ended 12 Months Ended 1 Months Ended 12 Months Ended 12 Months Ended 0 Months Ended 12 Months Ended
    Apr. 06, 2011
    Jul. 28, 2011
    Dec. 31, 2012
    Dec. 31, 2011
    Dec. 31, 2010
    Dec. 31, 2001
    2001 Stock Plan [Member]
    Dec. 31, 2012
    2001 Stock Plan [Member]
    Dec. 31, 2012
    Subsequent Event [Member]
    Oct. 25, 2012
    Warrant [Member]
    Mar. 15, 2012
    Warrant [Member]
    Feb. 02, 2012
    Warrant [Member]
    Dec. 31, 2012
    Warrant [Member]
    Jul. 28, 2011
    Warrant [Member]
    Apr. 06, 2011
    Warrant [Member]
    Dec. 31, 2012
    Warrant [Member]
    General And Administrative Expenses And Research And Development Expense [Member]
    Dec. 31, 2012
    Epitope [Member]
    Apr. 06, 2011
    Common Stock Purchase Agreement With Single Investors [Member]
    Jan. 28, 2011
    Common Stock Purchase Agreement With Single Investors [Member]
    Jul. 02, 2010
    Common Stock Purchase Agreement With Single Investors [Member]
    Apr. 06, 2011
    Stock Purchase Agreement With Three Institutional Investors [Member]
    Jan. 28, 2011
    Stock Purchase Agreement With Three Institutional Investors [Member]
    Apr. 06, 2011
    Common Stock Purchase Agreement With Institutional Investors [Member]
    Apr. 06, 2011
    Consulting Agreement For Financial Advisory Services [Member]
    Dec. 31, 2012
    Employees and Consultants [Member]
    Dec. 31, 2011
    Employees and Consultants [Member]
    Dec. 31, 2012
    Employee [Member]
    General And Administrative Expenses And Research And Development Expense [Member]
    Dec. 31, 2011
    Employee [Member]
    General And Administrative Expenses And Research And Development Expense [Member]
    Dec. 31, 2012
    Consultant [Member]
    General And Administrative Expenses And Research And Development Expense [Member]
    Dec. 31, 2011
    Consultant [Member]
    General And Administrative Expenses And Research And Development Expense [Member]
    Dec. 31, 2012
    2007 Stock Plan [Member]
    Mar. 20, 2007
    2007 Stock Plan [Member]
    Dec. 31, 2012
    2010 Stock Plan [Member]
    Nov. 02, 2010
    2010 Stock Plan [Member]
    Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number     4,453,746 2,979,010 2,539,091   1,066,007                 50,000                           872,739 2,500,000 2,515,000 3,000,000
    Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross           250,000                                   2,075,000 557,002                
    Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Fair Value                                               $ 4,500,000 $ 609,000                
    Issuance Of Warrants To Purchase Of Common Stock 844,391               635,855                       1,428,572 844,391                      
    Warrants Exercise Price Per Share   $ 1.00             $ 1.60                       $ 2.00   $ 1.40                    
    Life Of Warrants                                     5 years                            
    Warrants Expiration Date                                     Dec. 31, 2015                            
    Warrants Floor Price Per Share                                       $ 1.40 $ 1.40 $ 1.00                      
    Warrant expense 716,000   0 1,492,000       776,000                                                  
    Change in fair value of warrant liability     0 242,000                                                          
    Options Exercisable, Weighted Average Exercise Price     $ 1.60                         $ 0.001                                  
    Options Outstanding, Weighted Average Remaining Contractual Life     6 years 5 months 5 days 6 years 0 months 4 days 6 years 11 months 19 days                     5 years 5 months                                  
    Number of Options, Balance exercisable     2,891,877                         40,000                                  
    Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value                 $ 1.60                                                
    Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Outstanding Weighted Average Remaining Contractual Terms     3 years 9 months 18 days           5 years               15 months 15 months                              
    Investment Warrants Expiration Date                 Oct. 25, 2017                                                
    Share Based Compensation Arrangement By Share Based Payment Award Warrants Exercisable Number                   250,000 100,000                                            
    Share Based Compensation Arrangement By Share Based Payment Award Warrants Vested and Expected To Vest Outstanding Number                   50,000                                              
    Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price     $ 0.34 $ 0.57                                                          
    Issunance Of Warrants Expenses Recognized                       63,000                                          
    Share Based Compensation Arrangement By Share Based Payment Award Warrants Exercisable In Period                   2 years 5 years                                            
    Warrants Exercisable Price Per Share                   $ 2.20                                              
    Warrants Fair Value       0               200,000                                          
    Employee Service Share-based Compensation, Nonvested Awards, Total Compensation Cost Not yet Recognized, Stock Options     3,200,000                                                            
    Derivative Liability, Fair Value, Gross Liability                         253,000 1,500,000                                      
    Increase In Fair Value Of Warrant Liability 765,000                                                                
    Share Based Compensation Arrangement By Share Based Payment Award, Warrant Exercisable Price $ 2.0725                                                                
    Share Based Compensation Arrangement By Share Based Payment Award, Warrant Exercisable Period 13 months                                                                
    Anti Dilution Price Protection Warrants Price Per Share $ 2.0725                                                                
    Decrease In Fair Value Of Warrant Liability   523,000                                                              
    Allocated Share-Based Compensation Expense                             271,000                     1,400,000 268,000 216,000 705,000        
    Employee Service Share-based Compensation, Cash Received from Exercise of Stock Options     $ 127,000 $ 15,000                                                          
    XML 32 R33.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Selected Balance Sheet Information (Details) (USD $)
    In Thousands, unless otherwise specified
    Dec. 31, 2012
    Dec. 31, 2011
    Accounts receivable $ 682 $ 692
    Bad debt allowance - customer (682) (287)
    Total $ 0 $ 405
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    Income Taxes (Tables)
    		 12 Months Ended
    Dec. 31, 2012
    Income Tax Disclosure [Abstract]  
    Schedule of Components of Income Tax Expense (Benefit) [Table Text Block]

    The Company’s tax expense differs from the “expected” tax expense for the years ended December 31, 2012 (computed by applying the Federal Corporate tax rate of 34% to loss before taxes and 3.96% for Michigan State Corporate taxes, the blended rate used was 37.96%) and December 31, 2011, (computed by applying the Federal Corporate tax rate of 32.13% to loss before taxes and 5.5% for Michigan State Corporate taxes, the blended rate used was 37.63%), as follows (in thousands):

     

        2012     2011  
    Computed “expected” tax benefit - Federal   $ (5,803 )   $ (2,618 )
    Computed “expected” tax benefit - State     (676 )     (448 )
    Meals, entertainment and other     5     5  
    Non-deductible stock-based compensation     518       366  
    Warrant expense     -       562  
    Change in fair value of warrant expense     -       91  
    Realized loss on debt securities     -       7  
    Change in valuation allowance     5,956       2,035  
        $ -     $ -  
    Schedule of Deferred Tax Assets and Liabilities [Table Text Block]

    The effects of temporary differences that gave rise to significant portions of deferred tax assets at December 31, 2012 and 2011 are as follows (in thousands):

     

    Deferred tax assets:   2012     2011  
    Stock issued for services   $ 318   $ 321
    Bad debt – change in allowance     1,099     205
    Stock issued for acquisition of program     527     -  
    Net operating loss carry-forward     14,964     10,425
    Total gross deferred tax assets     16,908     10,951
    Less valuation allowance     (16,908 )     (10,951 )
    Net deferred tax assets   $    -     $ -  
    XML 35 R50.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Stock Repurchase Program (Details Textual) (USD $)
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2009
    Payments for Repurchase of Common Stock   $ 1,000,000
    Subsidiary or Equity Method Investee, Price-Per-Share   $ 5
    Stock Repurchase Program, Remaining Number of Shares Authorized to be Repurchased 81,482  
    Stock Repurchase Program, Remaining Authorized Repurchase Amount $ 50,000  
    Preferred Stock, Redemption Price Per Share $ 0.61  
    XML 36 R42.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Stock-Based Compensation (Details 5) (USD $)
    		 12 Months Ended 0 Months Ended 1 Months Ended 0 Months Ended 1 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Apr. 06, 2011
    Warrant [Member]
    Commitment Date [Member]
    Jul. 28, 2011
    Warrant [Member]
    Commitment Date [Member]
    Apr. 06, 2011
    Warrant [Member]
    Remeasurement Date [Member]
    Jul. 28, 2011
    Warrant [Member]
    Remeasurement Date [Member]
    Closing stock price     $ 1.39 $ 2.08 $ 2.08 $ 0.84
    Expected dividend rate 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%
    Expected stock price volatility 110.00% 174.00% 117.10% 112.10% 104.60% 105.60%
    Risk free interest rate 0.26% 0.71% 0.28% 0.29% 0.29% 0.21%
    Expected life (years) 2 years 5 years 1 year 29 days 1 year 29 days 10 months 6 days 1 year 15 days
    XML 37 R37.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Stock-Based Compensation (Details) (USD $)
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Expected dividends 0.00% 0.00%
    Expected volatility 110.00% 174.00%
    Risk fee interest rate 0.26% 0.71%
    Expected life of option (in years) 2 years 5 years
    Expected forfeitures 0.00% 0.00%
    Minimum [Member]
    		    
    Exercise price 1.69 0.49
    Expected volatility 108.00% 175.00%
    Risk fee interest rate 0.37% 1.30%
    Expected life of option (in years) 5 years 5 years
    Maximum [Member]
    		    
    Exercise price 2.47 2.22
    Expected volatility 174.00% 188.00%
    Risk fee interest rate 1.98% 3.58%
    Expected life of option (in years) 10 years 7 years
    XML 38 R52.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Income Taxes (Details 1) (USD $)
    In Thousands, unless otherwise specified
    Dec. 31, 2012
    Dec. 31, 2011
    Deferred tax assets:    
    Stock issued for services $ 318 $ 321
    Bad debt - change in allowance 1,099 205
    Stock issued for acquisition of program 527 0
    Net operating loss carry-forward 14,964 10,425
    Total gross deferred tax assets 16,908 10,951
    Less valuation allowance (16,908) (10,951)
    Net deferred tax assets $ 0 $ 0
    XML 39 R47.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Stockholders' Equity (Details Textual) (USD $)
    		 0 Months Ended 12 Months Ended 12 Months Ended 1 Months Ended 12 Months Ended
    Apr. 06, 2011
    Jan. 28, 2011
    Dec. 31, 2012
    Dec. 31, 2011
    Dec. 31, 2012
    Intrexon [Member]
    Dec. 31, 2011
    Intrexon [Member]
    Dec. 31, 2012
    Prev Abr Llc [Member]
    Oct. 31, 2012
    Private Placement [Member]
    Dec. 31, 2012
    Common Stock [Member]
    Dec. 31, 2011
    Common Stock [Member]
    Dec. 31, 2012
    Warrant [Member]
    Issuance of common stock, net of issuance costs (in shares) 1,688,782 2,857,144           6,750,000 6,750,000 4,545,926  
    Common Stock Closing Price Per Share               $ 1.60      
    Stock Issuance Cost $ 243,000 $ 296,000 $ 680,000 $ 539,000              
    Issuance of common stock for options exercised (in shares)     374,851 23,333              
    Proceeds from Stock Options Exercised     127,000                
    Issuance of common stock for consulting fees (in shares)                   171,796  
    Fair Value Of Stock Issued During Period Value Consulting Fees       165,000              
    Sale Of Stock For Consulting Fees Price Per Share       $ 0.96              
    Stock Issued During Period Shares For Exercise Of Stock Options And Warrants       28,333              
    Stock Issued During Period Fair Value For Exclusive Channel Collaboration Agreement                   1,700,000  
    Issuance of common stock for employee compensation (in shares)                   73,585  
    Issuance of common stock for employee compensation       94,000           0  
    Sale Of Stock For Employment Service Price Per Share       $ 1.29              
    Proceeds from issuance of common stock for warrant exercises 3,500,000 4,000,000   15,000              
    Stock Issued During Period Shares Stock Cashless Warrants Exercised       10,615              
    Issuance of common stock for exclusive channel collaboration agreement (in shares)                 3,552,210 3,123,558  
    Equity Issued in Business Combination, Fair Value Disclosure         7,800,000 1,700,000 1,200,000        
    Sale Of Stock For Channel Agreement Price Per Share         $ 2.20 $ 0.54 $ 1.87        
    Stock Issued During Period Shares Stock Warrants Exercised 844,391 1,428,572                  
    Share Based Compensation Arrangement By Share Based Payment Award Other Than Options Exercises In Period                     1,768,167
    Proceeds From Issuance Of Common Stock For Exclusive Channel Collaboration Agreement     0 3,000             2,000,000
    Stock Issued During Period, Shares, Acquisitions         3,552,210   625,000 3,125,000 625,000    
    Proceeds from Issuance of Private Placement               10,800,000      
    Noninterest Expense Offering Cost               $ 680,000      
    XML 40 R9.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Organization and Nature of Operations and Basis of Presentation
    		 12 Months Ended
    Dec. 31, 2012
    Organization, Consolidation and Presentation Of Financial Statements [Abstract]  
    Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]
      1. Organization and Nature of Operations and Basis of Presentation

     

    Description of Business

     

    Synthetic Biologics, Inc. (the “Company” or “Synthetic Biologics”) is a biotechnology company focused on the development of biologics for the prevention and treatment of serious infectious diseases. The Company is developing an oral enzyme for the prevention of C. difficile infections, and a series of monoclonal antibody therapies for the treatment of Pertussis and Acinetobacter infections. In addition, the Company is developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis and cognitive dysfunction in multiple sclerosis, and has partnered the development of a treatment for fibromyalgia.

     

    Therapeutic Area   Product Candidate   Status
             
    Relapsing-remitting MS  

    Trimesta

    (oral estriol)

    		   Patients fully enrolled in Phase II clinical trial;
    dosing and monitoring underway
             
    Cognitive dysfunction in MS  

    Trimesta

    (oral estriol)

    		   Patient enrollment underway in Phase II
    clinical trial
             
    C. difficile infection prevention   SYN-004
    (monoclonal antibody)    		  

    Series of oral enzyme candidates; first generation candidate (formerly known as P1A) is in Phase II;

    next generation candidate, SYN-004, (formerly known as P3A) is in preclinical
             
    Pertussis   SYN-005
    (monoclonal antibody)    		   Preclinical; Collaborations with Intrexon and The University of Texas at Austin
             
    Acinetobacter infection   SYN-001
    (monoclonal antibody)    		   Discovery; Collaboration with Intrexon
           
    Fibromyalgia   Effirma
    (oral flupirtine)    		   Partnered with Meda AB

     

    To prioritize the Company’s focus on the development of product candidates for the prevention and treatment of serious infectious diseases, it does not intend to pursue further development of the previously announced program for pulmonary arterial hypertension. However, the Company is currently in discussions with Intrexon to substitute this program with an alternate program better suited to its current objectives and focus.

     

    In order to further prioritize the Company’s focus, it has elected to discontinue further development of AEN-100 for the treatment of amyotrophic lateral sclerosis. However, the Company is currently seeking development partners for its zinc-based intellectual property and assets including, AEN-100.

     

    Basis of Presentation and Corporate Structure

     

    As of December 31, 2012, the Company had seven subsidiaries, Pipex Therapeutics, Inc. (“Pipex Therapeutics”), Effective Pharmaceuticals, Inc. (“EPI”), Solovax, Inc. (“Solovax”), CD4 Biosciences, Inc. (“CD4”), Epitope Pharmaceuticals, Inc. (“Epitope”), Healthmine, Inc. (“Healthmine”) and Putney Drug Corp. (“Putney”). As of December 31, 2012, Pipex Therapeutics, EPI, Healthmine and Putney are wholly owned and Solovax, CD4 and Epitope are majority-owned.

     

    For financial reporting purposes, the outstanding common stock of the Company is that of Synthetic Biologics, Inc. All statements of operations, stockholders’ equity and cash flows for each of the entities are presented as consolidated. All subsidiaries were formed under the laws of the State of Delaware on January 8, 2001, except for EPI, which was incorporated in Delaware on December 12, 2000, Epitope which was incorporated in Delaware in January of 2002, Putney which was incorporated in Delaware in November of 2006 and Healthmine which was formed in Delaware in December of 2007.

     

    On March 8, 2012, the Company sold all of its interest in Adeona Clinical Laboratory, LLC (the “Lab”) to Hartlab, LLC, an entity controlled by the Lab’s former owner, in consideration for (i) the immediate assignment of the Lab’s outstanding accounts receivable up through the date of closing, plus (ii) $700,000 payable pursuant to the terms of a two-year non-recourse promissory note secured by all the assets of the Lab. Accordingly, this business has been presented in the consolidated financial statements as discontinued operations. This transaction is described in more detail in Note 3 – Discontinued Operations of Adeona Clinical Laboratory.
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    In Thousands, unless otherwise specified
    		 0 Months Ended 12 Months Ended
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    Dec. 31, 2012
    Dec. 31, 2011
    Balance at December 31, 2010   $ 0 $ 0
    Warrant liability 716 0 1,492
    Change in fair value of warrant liability   0 242
    Reclassification of warrant liability to additional paid-in capital   0 (1,734)
    Balance at December 31, 2011   $ 0 $ 0
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    Summary of Significant Accounting Policies (Details Textual) (USD $)
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Dec. 31, 2010
    Additional Milestone Payments     $ 5,000,000
    Marketing Expense     10,000,000
    Royalty Revenue Percentage     7.00%
    Depreciation 63,000 144,000  
    Impairment loss on goodwill 47,000    
    Money Market Accounts and Mutual Funds [Member]
    		      
    Cash and Cash Equivalents, at Carrying Value 8,600,000 5,000,000  
    Warrant [Member]
    		      
    Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 1,632,501 3,259,186  
    Options Held [Member]
    		      
    Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 4,453,746 2,979,010  
    Mclean Hospital [Member]
    		      
    License revenue, net     (375,000)
    License Revenue Percentage     15.00%
    Meda Agreement [Member]
    		      
    License revenue, net     $ 2,500,000
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    Summary of Significant Accounting Policies (Details 1)
    		 12 Months Ended
    Dec. 31, 2012
    Leasehold improvements and fixtures Lesser of estimated useful or life of lease
    Office Equipment and Furniture [Member] | Maximum [Member]
    		  
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    Office Equipment and Furniture [Member] | Minimum [Member]
    		  
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    Laboratory Equipment [Member] | Maximum [Member]
    		  
    Estimated Useful Life 10 years
    Laboratory Equipment [Member] | Minimum [Member]
    		  
    Estimated Useful Life 7 years
    Manufacturing Equipment [Member]
    		  
    Estimated Useful Life 10 years
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    Stock-Based Compensation (Details 7) (Warrant [Member], USD $)
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Warrant [Member]
    		    
    Number of Warrants, Beginning Balance 3,259,186 1,131,078
    Number of Warrants, Granted 985,855 2,272,963
    Number of Warrants, Exercised (1,768,167) (15,615)
    Number of Warrants, Forfeited (844,373) (129,240)
    Number of Warrants, Ending Balance 1,632,501 3,259,186
    Weighted Average Exercise Price, Beginning Balance $ 1.95 $ 3.49
    Weighted Average Exercise Price, Granted $ 1.71 $ 1.25
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    XML 46 R30.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Discontinued Operations of Adeona Clinical Laboratory and Note Receivable (Details) (USD $)
    In Thousands, unless otherwise specified
    Dec. 31, 2012
    Dec. 31, 2011
    Assets of discontinued operations:    
    Property and equipment, net $ 0 $ 23
    Total assets $ 0 $ 23
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    Discontinued Operations of Adeona Clinical Laboratory and Note Receivable (Details 1) (USD $)
    In Thousands, unless otherwise specified
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Operating Costs and Expenses:    
    General and administrative $ 5,012 $ 2,588
    Other Income:    
    Income (loss) from discontinued operations 216 (523)
    Adeona Clinical Laboratory [Member]
    		    
    Laboratory fees, net 115 1,169
    Operating Costs and Expenses:    
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    Cost of laboratory services 110 975
    Impairment loss on goodwill 0 178
    Total operating costs and expenses 576 1,692
    Loss from discontinued operations (461) (523)
    Other Income:    
    Gain on sale of Adeona Clinical Laboratory 677 0
    Income (loss) from discontinued operations $ 216 $ (523)
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    In Thousands, unless otherwise specified
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Payments of Stock Issuance Costs $ 680 $ 539
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    Promissory Note [Member] | Adeona Clinical Laboratory, Llc [Member]
    		  
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    Long-term Debt, Percentage Bearing Variable Interest, Percentage Rate 5.70%
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    Stock-Based Compensation (Details 3) (USD $)
    		 12 Months Ended
    Dec. 31, 2012
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    Stock Options, Granted 2,075,000
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    Income Taxes (Details Textual) (USD $)
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Effective Income Tax Rate Reconciliation, At Federal Statutory Income Tax Rate 34.00% 32.13%
    Effective Income Tax Rate Reconciliation, State and Local Income Taxes 3.96% 5.50%
    Effective Income Tax Rate Reconciliation, Change In Enacted Tax Rate 37.96% 37.63%
    Valuation Allowance, Amount $ 16,908,000 $ 10,951,000
    Valuation Allowance, Deferred Tax Asset, Change In Amount 5,956,000 2,035,000
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    Increase (Decrease) in Deferred Liabilities 0 0
    Increase (Decrease) in Deferred Revenue 0 0
    Liability for Uncertain Tax Positions, Current 0 0
    Taxable Income Expiring Through 2032 [Member]
    		    
    Operating Loss Carryforwards $ 39,700,000  
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    Consolidated Balance Sheets (USD $)
    In Thousands, unless otherwise specified
    Dec. 31, 2012
    Dec. 31, 2011
    Assets    
    Cash $ 9,954 $ 6,678
    Accounts receivable - net 0 405
    Prepaid expenses and other current assets 2,509 16
    Assets of discontinued operations 0 23
    Total Current Assets 12,463 7,122
    Property and equipment, net 223 323
    Long-term note receivable 700 0
    Deposits and other assets 37 31
    Total Assets 13,423 7,476
    Liabilities and Stockholders' Equity    
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    Accrued liabilities 0 29
    Total Current Liabilities 395 417
    Total Liabilities 395 417
    Stockholders' Equity:    
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    Common stock, $0.001 par value; 100,000,000 shares authorized, 44,444,230 issued and 44,362,748 outstanding and 31,374,002 issued and 31,292,520 outstanding 44 31
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    Accumulated deficit (68,941) (51,873)
    Total Stockholders' Equity 13,028 7,059
    Total Liabilities and Stockholders' Equity $ 13,423 $ 7,476
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    Stock-Based Compensation (Details 8) (USD $)
    		 12 Months Ended
    Dec. 31, 2012
    Exercise Price $ 1.99
    Warrants Outstanding 1,632,501
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    Weighted Average Remaining Contractual Life 3 years 9 months 18 days
    Aggregate Intrinsic value $ 172,000
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    Exercise Price $ 1.14
    Warrants Outstanding 100,000
    Warrants Exercisable 100,000
    Weighted Average Remaining Contractual Life 4 years 1 month 2 days
    Aggregate Intrinsic value $ 62,000
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    Warrants Exercisable 18,182
    Weighted Average Remaining Contractual Life 3 years
    Aggregate Intrinsic value $ 8,000
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    Warrants Exercisable 635,855
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    Aggregate Intrinsic value $ 102,000
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    Warrants Exercisable 50,000
    Weighted Average Remaining Contractual Life 1 year 2 months 12 days
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    Warrants Exercisable 517,257
    Weighted Average Remaining Contractual Life 3 years 10 months 28 days
    Aggregate Intrinsic value $ 0
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    Warrants Exercisable 61,207
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    Aggregate Intrinsic value $ 0
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    Warrants Outstanding 50,000
    Warrants Exercisable 50,000
    Weighted Average Remaining Contractual Life 3 years 1 month 17 days
    Aggregate Intrinsic value $ 0
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    Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) (USD $)
    In Thousands, unless otherwise specified
    		 0 Months Ended 12 Months Ended
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    Jan. 28, 2011
    Dec. 31, 2012
    Dec. 31, 2011
    Stock Issuance Cost $ 243 $ 296 $ 680 $ 539
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    In Thousands, unless otherwise specified
    Dec. 31, 2012
    Dec. 31, 2011
    Property, Plant and Equipment, Gross $ 465 $ 695
    Less accumulated depreciation (242) (372)
    Property and equipment, net 223 323
    Manufacturing equipment [Member]
    		    
    Property, Plant and Equipment, Gross 297 400
    Computer and Office Equipment [Member]
    		    
    Property, Plant and Equipment, Gross 35 159
    Laboratory Equipment [Member]
    		    
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    Selected Balance Sheet Information (Tables)
    		 12 Months Ended
    Dec. 31, 2012
    Organization, Consolidation and Presentation Of Financial Statements [Abstract]  
    Schedule of Accounts, Notes, Loans and Financing Receivable [Table Text Block]

    Accounts receivable (in thousands)

     

        December 31,  
        2012     2011  
    Accounts receivable   $ 682     $ 692  
    Bad debt allowance - customer     (682 )     (287 )
    Total   $ -     $ 405  
    Schedule of Other Current Assets [Table Text Block]

    Prepaid expenses and other current assets (in thousands)

        December 31,  
        2012     2011  
    Intrexon prepaid research and development expenses   $ 2,412     $ -  
    Other receivables     17          
    Prepaid expenses     80       16  
    Total   $ 2,509     $ 16  
    Property, Plant and Equipment [Table Text Block]

    Property and equipment (in thousands) 

        December 31,  
        2012     2011  
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    Computer and office equipment     35       159  
    Laboratory equipment     133       136  
          465       695  
    Less accumulated depreciation     (242 )     (372 )
    Total   $ 223     $ 323  
    Accrued Expenses [Table Text Block]

    Accrued liabilities (in thousands) 

        December 31,  
        2012     2011  
    Accrued vendor payments   $ -     $ 1  
    Compensation     -       28  
    Total   $ -     $ 29  
    XML 57 R36.htm IDEA: XBRL DOCUMENT v2.4.0.6
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    In Thousands, unless otherwise specified
    Dec. 31, 2012
    Dec. 31, 2011
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    Compensation 0 28
    Total $ 0 $ 29
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    License, Collaborative and Employment Agreements and Commitments (Tables)
    		 12 Months Ended
    Dec. 31, 2012
    Disclosure Of License Collaborative and Employment Agreements and Commitments [Abstract]  
    Due For License Agreements [Table Text Block]

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    Year Ending December 31,        
    2013   $ 287  
    2014     60  
    2015     35  
    2016     10  
    2017     10  
    Total   $ 402  
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    Consolidated Statements of Cash Flows (USD $)
    In Thousands, unless otherwise specified
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Cash Flows From Operating Activities:    
    Net Loss $ (17,068) $ (8,149)
    Adjustments to reconcile net loss to net cash used in operating activities:    
    Stock-based compensation 1,851 973
    Stock issued as compensation 0 94
    Stock issued for consulting fees 0 165
    Stock issued for exclusive channel collaboration agreement 7,815 1,684
    Stock issued for acquisition of program assets 1,169 0
    Warrant expense 0 1,492
    Change in fair value of warrant liability 0 242
    Depreciation 63 144
    Provision for uncollectible accounts receivable 442 414
    Gain on sale of discontinued operations (677) 0
    Amortization of premium on investments 0 57
    Loss on sale of short-term investments 0 20
    Loss on sale of equipment 0 6
    Impairment on loss of equipment 47 0
    Gain on the settlement of accounts payable 0 (63)
    Changes in operating assets and liabilities:    
    Accounts receivable 14 (480)
    Prepaid expenses and other current assets (2,544) 327
    Deposits and other assets (6) 60
    Assets of discontinued operations 0 191
    Accounts payable 7 153
    Accrued liabilities (29) (181)
    Liabilities of discontinued operations 0 (24)
    Net Cash Used In Operating Activities (8,916) (2,875)
    Cash Flows From Investing Activities:    
    Purchase of short-term investments 0 (4,370)
    Proceeds from short-term investments 0 4,293
    Purchase of property and equipment (10) 0
    Proceeds from the sale of equipment 0 2
    Net Cash Used In Investing Activities (10) (75)
    Cash Flows From Financing Activities:    
    Proceeds from issuance of common stock for stock option and warrant exercises 2,082 15
    Proceeds from issuance of common stock for exclusive channel collaboration agreement 0 3
    Proceeds from the issuance of common stock, net of issuance costs of $680 and $539, respectively 10,120 6,961
    Net Cash Provided By Financing Activities 12,202 6,979
    Net increase in cash 3,276 4,029
    Cash at beginning of year 6,678 2,649
    Cash at end of year 9,954 6,678
    Supplemental disclosures of cash flow information:    
    Cash paid for interest 0 0
    Cash paid for taxes 0 0
    Supplemental disclosures of non-cash investing and financing activities:    
    Reclassification of warrant liability to additional paid-in-capital $ 0 $ 1,734
    XML 61 R3.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Consolidated Balance Sheets (Parenthetical) (USD $)
    Dec. 31, 2012
    Dec. 31, 2011
    Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
    Preferred stock, shares authorized 10,000,000 10,000,000
    Preferred stock, shares issued 0 0
    Preferred stock, shares outstanding 0 0
    Common stock, par value (in dollars per share) $ 0.001 $ 0.001
    Common stock, shares authorized 100,000,000 100,000,000
    Common stock, shares, issued 44,444,230 31,374,002
    Common stock, shares outstanding 44,362,748 31,292,520
    XML 62 R17.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Income Taxes
    		 12 Months Ended
    Dec. 31, 2012
    Income Tax Disclosure [Abstract]  
    Income Tax Disclosure [Text Block]
    9. Income Taxes

     

    There was no income tax expense for the years ended December 31, 2012 and 2011 due to the Company’s net losses.

     

    The Company’s tax expense differs from the “expected” tax expense for the years ended December 31, 2012 (computed by applying the Federal Corporate tax rate of 34% to loss before taxes and 3.96% for Michigan State Corporate taxes, the blended rate used was 37.96%) and December 31, 2011, (computed by applying the Federal Corporate tax rate of 32.13% to loss before taxes and 5.5% for Michigan State Corporate taxes, the blended rate used was 37.63%), as follows (in thousands):

     

        2012     2011  
    Computed “expected” tax benefit - Federal   $ (5,803 )   $ (2,618 )
    Computed “expected” tax benefit - State     (676 )     (448 )
    Meals, entertainment and other     5     5  
    Non-deductible stock-based compensation     518       366  
    Warrant expense     -       562  
    Change in fair value of warrant expense     -       91  
    Realized loss on debt securities     -       7  
    Change in valuation allowance     5,956       2,035  
        $ -     $ -  

     

    The effects of temporary differences that gave rise to significant portions of deferred tax assets at December 31, 2012 and 2011 are as follows (in thousands):

     

    Deferred tax assets:   2012     2011  
    Stock issued for services   $ 318   $ 321
    Bad debt – change in allowance     1,099     205
    Stock issued for acquisition of program     527     -  
    Net operating loss carry-forward     14,964     10,425
    Total gross deferred tax assets     16,908     10,951
    Less valuation allowance     (16,908 )     (10,951 )
    Net deferred tax assets   $    -     $ -  

     

    At December 31, 2012, the Company has a net operating loss carry-forward of approximately $39.7 million available to offset future taxable income expiring through 2032. However, utilization of these net operating losses may be limited due to potential ownership changes under Section 382 of the Internal Revenue Code.

     

    The valuation allowance at December 31, 2011 was approximately $11.0 million. The net change in valuation allowance during the year ended December 31, 2012 was an increase of approximately $6.0 million. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The ultimate realization of deferred income tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred income tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. Based on consideration of these items, management has determined that enough uncertainty exists relative to the realization of the deferred income tax asset balances to warrant the application of a full valuation allowance as of December 31, 2012.

     

    ASC 740-10 “Accounting for Uncertain Tax Positions” prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return and also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition.

     

    As of December 31, 2012 and 2011, the Company had no unrecognized tax benefits and no adjustments to liabilities or operations were required under ASC 740-10. The Company’s practice was and continues to be to recognize interest and penalty expenses related to uncertain tax positions in income tax expense, which was zero for the years ended December 31, 2012 and 2011. The Company files United States federal and various state income tax returns.

     

    The Company is routinely subject to examinations by taxing authorities in these various jurisdictions. The Company’s U.S. tax matters for the years 2000 through 2012 remain subject to examination by the Internal Revenue Service due to the Company’s NOL carryforwards. The Company’s U. S. tax matters remain subject to examination by various state and local tax jurisdictions due to our NOL carryforwards.

     

    The Company does not anticipate that it is reasonably possible that unrecognized tax benefits as of December 31, 2012 will significantly change within the next 12 months.
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    Document and Entity Information (USD $)
    		 12 Months Ended
    Dec. 31, 2012
    Mar. 27, 2013
    Jun. 30, 2012
    Entity Registrant Name Synthetic Biologics, Inc.    
    Entity Central Index Key 0000894158    
    Current Fiscal Year End Date --12-31    
    Entity Filer Category Smaller Reporting Company    
    Trading Symbol syn    
    Entity Common Stock, Shares Outstanding   44,654,414  
    Document Type 10-K    
    Amendment Flag false    
    Document Period End Date Dec. 31, 2012    
    Document Fiscal Period Focus FY    
    Document Fiscal Year Focus 2012    
    Entity Well-Known Seasoned Issuer No    
    Entity Voluntary Filers No    
    Entity Current Reporting Status Yes    
    Entity Public Float     $ 44,969,000
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    Related Party Transactions
    		 12 Months Ended
    Dec. 31, 2012
    Related Party Transactions [Abstract]  
    Related Party Transactions Disclosure [Text Block]

    10. Related Party Transactions

     

    In February 2012, the Company entered into a consulting agreement with Dr. James Kuo, a director of the Company.

     

    From January 2, 2012 through September 30, 2012, Steve H. Kanzer was engaged as the Company’s Interim Director of its Biologics Division. In connection with his appointment, Mr. Kanzer entered into a six month employment agreement with us on a full time basis (the “Kanzer Employment Agreement”), which may be extended for an additional three (3) months upon consent of the parties. Pursuant to the Kanzer Employment Agreement, Mr. Kanzer will be entitled to a base salary of $90,000 for the term, healthcare coverage pursuant to the Company’s healthcare insurance plan, reimbursement for certain relocation expenses and rent expense. The Kanzer Employment Agreement also includes confidentiality obligations and inventions assignments by Mr. Kanzer.  Mr. Kanzer is not entitled to severance pay upon termination of his employment. On October 1, 2012, the Kanzer Employment Agreement was amended (the “Amended Kanzer Employment Agreement”) and Mr. Kanzer is engaged as the Company Licensing Associate. In connection with this appointment, Mr. Kanzer entered into a two year agreement with us on a part time basis (2.5 days per week). Pursuant to the Amended Kanzer Employment Agreement, Mr. Kanzer will be entitled to a base salary of $150,000 for the term and healthcare coverage pursuant to the Company’s healthcare insurance plans.

     

    In August 2012, the Company entered into an Exclusive Channel Agreement with Intrexon and issued 3,552,210 shares of common stock as consideration, having a fair value of $7.8 million ($2.20 per share), based on the quoted closing trading price on October 5, 2012. In November 2011, the Company entered into an Exclusive Channel Agreement with Intrexon and issued 3,123,558 shares of common stock as consideration, having a fair value of $1.7 million ($0.54 per share), based on the quoted closing trading price. In connection with the November 2011 and August 2012 Exclusive Channel Agreements, the Company paid Intrexon approximately $2.9 million during 2012, including a prepayment of research and development expenses of $2.5 million for research and development goods and services to be provided in the future which has been recorded on the Company’s balance sheet in prepaid expense as described in Note 4. In October 2012, the Company consummated the Company’s October 2012 Private Placement and entered into a stock purchase agreement with several investors, including NRM VII Holdings I, LLC, an entity affiliated with Intrexon. Randal J. Kirk, directly and through certain affiliates, has voting and dispositive power over a majority of the outstanding capital of Intrexon Corporation, and controls NRM VII Holdings I, LLC. Mr. Kirk disclaims beneficial ownership of the shares held by Intrexon Corporation and NRM VII Holdings I, LLC, except to the extent of any pecuniary interest therein.
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    Consolidated Statements of Operations (USD $)
    In Thousands, except Share data, unless otherwise specified
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Operating Costs and Expenses:    
    General and administrative $ 5,012 $ 2,588
    Research and development 12,287 3,340
    Total Operating Expenses 17,299 5,928
    Loss from Operations (17,299) (5,928)
    Other Income (Expense):    
    Warrant expense 0 (1,492)
    Change in fair value of warrant liability 0 (242)
    Interest income 33 14
    Other income (expense) (18) 22
    Total Other Income (Expense), net 15 (1,698)
    Loss from Continuing Operations (17,284) (7,626)
    Income (Loss) from Discontinued Operations 216 (523)
    Net Loss and Comprehensive Loss $ (17,068) $ (8,149)
    Net Income (Loss) Per Share - Basic and Dilutive:    
    Continuing operations (in dollars per share) $ (0.50) $ (0.27)
    Discontinued operations (in dollars per share) $ 0.01 $ (0.02)
    Net Income (Loss) Per Share (in dollars per share) $ (0.49) $ (0.29)
    Weighted average number of shares outstanding during the period - Basic and Dilutive (in shares) 34,896,592 27,710,428
    XML 66 R12.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Selected Balance Sheet Information
    		 12 Months Ended
    Dec. 31, 2012
    Organization, Consolidation and Presentation Of Financial Statements [Abstract]  
    Supplemental Balance Sheet Disclosures [Text Block]
    4. Selected Balance Sheet Information

     

    Accounts receivable (in thousands)

     

        December 31,  
        2012     2011  
    Accounts receivable   $ 682     $ 692  
    Bad debt allowance - customer     (682 )     (287 )
    Total   $ -     $ 405  

     

    Prepaid expenses and other current assets (in thousands)

        December 31,  
        2012     2011  
    Intrexon prepaid research and development expenses - See Note 10   $ 2,412     $ -  
    Other receivables     17       -  
    Prepaid expenses     80       16  
    Total   $ 2,509     $ 16  

     

    The Intrexon prepaid research and development expenses are classified as a current asset. The Company may terminate the arrangement at any time and receive a cash refund of the remaining balance minus any amounts owed to Intrexon. The Company anticipates that the majority of the prepaid will be applied to research and development goods and services during 2013.

     

    Property and equipment (in thousands) 

        December 31,  
        2012     2011  
    Manufacturing equipment   $ 297     $ 400  
    Computer and office equipment     35       159  
    Laboratory equipment     133       136  
          465       695  
    Less accumulated depreciation     (242 )     (372 )
    Total   $ 223     $ 323  

     

    Accrued liabilities (in thousands) 

        December 31,  
        2012     2011  
    Accrued vendor payments   $ -     $ 1  
    Compensation     -       28  
    Total   $ -     $ 29  
    XML 67 R11.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Discontinued Operations of Adeona Clinical Laboratory and Note Receivable
    		 12 Months Ended
    Dec. 31, 2012
    Discontinued Operations and Disposal Groups [Abstract]  
    Disposal Groups, Including Discontinued Operations, Disclosure [Text Block]
    3. Discontinued Operations of Adeona Clinical Laboratory and Note Receivable

     

    On March 8, 2012, the Company sold all of its interest in Adeona Clinical Laboratory, LLC (the “Lab”) to Hartlab, LLC, an entity controlled by the Lab’s former owner. In connection with the sale of the Lab, the consideration received was (i) the immediate assignment of the Lab’s outstanding accounts receivable up through the date of closing, plus (ii) $700,000 payable pursuant to the terms of a two-year promissory note bearing interest at 5.7% per annum secured by all of the assets of the Lab. The note and all unpaid interest are due on March 1, 2014.

     

    In accordance with ASC Topic 205-20 “Presentation of Financial Statements—Discontinued Operations” (ASC 205-20), the Company determined that all the criteria for reporting a discontinued operation had been met. Accordingly, the Lab has been classified as a discontinued operation and its results of operations, financial position and cash flows are separately reported for all periods presented. The assets of the discontinued operations are presented separately under the caption “Assets of discontinued operations” in the accompanying Consolidated Balance Sheets at December 31, 2012, and December 31, 2011, and consist of the following (in thousands):

     

        December 31,  
        2012     2011  
    Assets of discontinued operations:            
    Property and equipment, net   $ -     $ 23  
    Total assets   $ -     $ 23  

     

    The summarized statement of operations data for Adeona Clinical Laboratory for the years ended December 31, 2012 and December 31, 2011 are as follows (in thousands):

     

        December 31,  
        2012     2011  
    Laboratory fees, net   $ 115     $ 1,169  
                     
    Operating Costs and Expenses:                
    General and administrative     466       539  
    Cost of  laboratory services     110       975  
    Impairment loss on goodwill     -       178  
    Total operating costs and expenses     576       1,692  
    Loss from discontinued operations     (461 )     (523 )
                     
    Other Income:                
    Gain on sale of Adeona Clinical Laboratory     677       -  
    Income (loss) from discontinued operations   $ 216     $ (523 )
    XML 68 R23.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Stock-Based Compensation (Tables)
    		 12 Months Ended
    Dec. 31, 2012
    Disclosure Of Compensation Related Costs, Share-Based Payments [Abstract]  
    Share-based Compensation Arrangement by Share-based Payment Award Options and Warrants Vested and Expected to Vest Outstanding and Exercisable [Table Text Block]

    The Company has applied fair value accounting for all share based payment awards since inception. The fair value of each option or warrant granted is estimated on the date of grant using the Black-Scholes option pricing model. The Black-Scholes assumptions used in the years ended December 31, 2012 and 2011 are as follows:

     

        Year ended December 31,
        2012   2011
    Exercise price   $1.69 - $2.47   $0.49 - $2.22
    Expected dividends   0%   0%
    Expected volatility   108% - 174%   175% - 188%
    Risk fee interest rate   0.37% - 1.98%   1.30% - 3.58%
    Expected life of option   5 - 10 years   5 - 7 years
    Expected forfeitures   0%   0%
    Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block]

    During 2012, the Company granted 2,075,000 options to employees and consultants having an approximate fair value of $4.5 million based upon the Black-Scholes option pricing model.  During 2011, the Company granted 557,002 options to employees and consultants having an approximate fair value of $609,000 based upon the Black-Scholes option pricing model.

                    Weighted        
                    Average        
              Weighted     Remaining     Aggregate  
              Average Exercise     Contractual     Intrinsic  
        Options     Price     Life     Value  
    Balance – December 31, 2010     2,539,091     $ 1.32       6.97 years     $ 1,028,000  
    Granted     557,002     $ 1.26                  
    Exercised     (23,333 )   $ 0.57                  
    Forfeited     (93,750 )   $ 0.59                  
    Balance – December 31, 2011     2,979,010     $ 1.34       6.01 years     $ -  
    Granted     2,075,000     $ 2.21                  
    Exercised     (374,851 )   $ 0.34                  
    Forfeited     (225,413 )   $ 2.37                  
    Balance – December 31, 2012 – outstanding     4,453,746     $ 1.78       6.43 years     $ 1,308,000  
    Balance – December 31, 2012 – exercisable     2,891,877     $ 1.60       5.71 years     $ 1,160,000  
                                     
    Grant date fair value of options granted – 2012           $ 4,467,984                  
    Weighted average grant date fair value – 2012           $ 2.15                  
    Grant date fair value of options granted – 2011           $ 609,000                  
    Weighted average grant date fair value – 2011           $ 1.09                  
    Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding and Exercisable [Table Text Block]

    The options outstanding and exercisable at December 31, 2012 are as follows:

     

    Options Outstanding   Options Exercisable
              Weighted     Weighted Average         Weighted     Weighted Average
    Range of         Average     Remaining         Average     Remaining
    Exercise Price   Options     Exercise Price     Contractual Life   Options     Exercise Price     Contractual Life
    $0.09 - $2.00     2,162,362     $ 1.78     5.76 years     1,801,187     $ 1.14     5.52 years
    $2.01 - $3.00     2,212,227       2.26     7.15 years     1,011,533       2.17     6.14 years
    $3.01 - $6.00     79,157       4.87     4.49 years     79,157       4.87     4.49 years
    $0.09 - $6.00     4,453,746     $ 1.78     6.43 years     2,891,877     $ 1.60     5.71 years

     

    The options outstanding and exercisable at December 31, 2011 are as follows:

     

    Options Outstanding   Options Exercisable
              Weighted     Weighted Average         Weighted     Weighted Average
    Range of         Average     Remaining         Average     Remaining
    Exercise Price   Options     Exercise Price     Contractual Life   Options     Exercise Price     Contractual Life
    $0.09 - $4.57     2,889,011     $ 1.20     6.11 years     2,364,608     $ 1.29     5.72 years
    $4.58 - $9.05     89,999       5.93     2.76 years     89,999       5.93     2.76 years
    $0.09 - $9.05     2,979,010     $ 1.34     6.01 years     2,454,607     $ 1.46     5.62 years
    Share Based Compensation Arrangement By Share Based Payment Award Options Non Vested and Expected To Vest Exercisable [Table Text Block]

    The following is a summary of the Company’s non-vested stock options at December 31, 2012:

     

            Weighted Average  
        Unvested     Grant  
        Stock Options     Date Fair Value  
    Non-vested – December 31, 2011     524,403     $ 0.82  
    Granted     2,075,000       2.21  
    Vested/Exercised     (891,332 )     0.81  
    Forfeited/Cancelled     (146,202 )     1.79  
    Non-vested – December 31, 2012     1,561,869     $ 2.11  
    Weighted average remaining period for vesting     2.09 years
    Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]

    The assumptions used by the Company are summarized in the following table:

     

    Exercise price $2.20 
    Expected dividends  0%
    Expected volatility  110%
    Risk free interest rate  0.26%
    Expected life of warrant  2 years 

     

    The assumptions used by the Company are summarized in the following table:

     

    Exercise price $1.14 
    Expected dividends  0%
    Expected volatility  174%
    Risk free interest rate  0.71%
    Expected life of warrant  5 years 
    Schedule Of Share Based Payment Award Warrants Valuation Assumptions [Table Text Block]
    On April 6, 2011, the fair value of the warrant liability was $1.5 million, which represented an increase in fair value of $765,000. The fair value was measured using the Black-Scholes valuation model. The assumptions used by the Company are summarized in the following table:

     

              Remeasurement  
        Commitment     Date  
        Date     April 6, 2011  
    Closing stock price   $ 1.39     $ 2.08  
    Expected dividend rate     0 %     0 %
    Expected stock price volatility     117.1 %     104.6 %
    Risk free interest rate     0.28 %     0.29 %
    Expected life (years)     1.08       0.85  

     

    On July 28, 2011, the fair value of the warrant liability was $253,000, which represented a decrease in fair value of $523,000. The fair value is measured using the Black-Scholes valuation model. The assumptions used by the Company are summarized in the following table:

     

              Remeasurement  
        Commitment     Date  
        Date     July 28, 2011  
    Closing stock price   $ 2.08     $ 0.84  
    Expected dividend rate     0 %     0 %
    Expected stock price volatility     112.1 %     105.6 %
    Risk free interest rate     0.29 %     0.21 %
    Expected life (years)     1.08       1.04  

     
    Schedule of Derivative Liabilities at Fair Value [Table Text Block]

    The following table summarizes the estimated fair value of the warrant liabilities at December 31, 2011(in thousands):

     

    Balance at December 31, 2010 $- 
    Warrant liability  1,492 
    Change in fair value of warrant liability  242 
    Reclassification to additional paid-in capital  (1,734)
    Balance at December 31, 2011 $- 
    Schedule Of Warrant Activity [Table Text Block]

    A summary of warrant activity for the Company for the year ended December 31, 2011 and for the year ended December 31, 2012 is as follows:

     

         Weighted Average 
      Number of Warrants  Exercise Price 
    Balance at December 31, 2010  1,131,078  $3.49 
    Granted  2,272,963   1.25 
    Exercised  (15,615)  1.03 
    Forfeited  (129,240)  2.08 
    Balance as December 31, 2011  3,259,186   1.95 
    Granted  985,855   1.71 
    Exercised  (1,768,167)  1.11 
    Forfeited  (844,373)  3.32 
    Balance as December 31, 2012  1,632,501  $1.99
    Schedule Of Warrant Outstanding and Exercisable [Table Text Block]

    A summary of all outstanding and exercisable warrants as of December 31, 2012 is as follows:

     

     

    Exercise
    Price    		  Warrants
    Outstanding    		  Warrants
    Exercisable    		  Weighted Average
    Remaining
    Contractual Life    		  Aggregate
    Intrinsic Value    		 
    $1.14   100,000   100,000   4.09 years  $62,000 
    $1.32   18,182   18,182   3.00 years  $8,000 
    $1.60   635,855   635,855   4.83 years  $102,000 
    $2.20   250,000   50,000   1.20 years  $  
    $2.22   517,257   517,257   3.91 years  $- 
    $3.30   61,207   61,207   3.30 years  $- 
    $3.75   50,000   50,000   3.13 years  $- 
    $1.99   1,632,501   1,432,501   3.80 years  $172,000
    XML 69 R19.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Summary of Significant Accounting Policies (Policies)
    		 12 Months Ended
    Dec. 31, 2012
    Accounting Policies [Abstract]  
    Consolidation, Policy [Policy Text Block]

    Principles of Consolidation

     

    All inter-company transactions and accounts have been eliminated in consolidation.
    Emerging From Development Stage [Policy Text Block]

    Emerging from the Development Stage

     

    During the second quarter of 2010, the Company emerged from the development stage.   A development-stage enterprise is one in which planned principle operations have not commenced or if its operations have commenced, there has been no significant revenue. On May 6, 2010, the Company entered into a Sublicense Agreement (the “Meda Agreement”) with Meda AB of Sweden (“Meda”) and received an up-front payment of $2.5 million. The execution of the Meda Agreement combined with revenues from Adeona Clinical Laboratory were an indication of the commencement of principal operations, and therefore development-stage reporting was no longer required.
    Use of Estimates, Policy [Policy Text Block]

    Use of Estimates

     

    The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the U.S.A. requires management to make estimates and assumptions that affect the reported amounts reported in the consolidated financial statements and accompanying notes. Such estimates and assumptions impact, among others, the following: the amount allocated to goodwill, the estimated useful lives for property and equipment, fair value of warrants and stock options granted for services or compensation, respectively, estimates of the probability and potential magnitude of contingent liabilities, and the valuation allowance for deferred tax assets due to continuing and expected future operating losses.

     

    Making estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set of circumstances that existed at the date of the consolidated financial statements, which management considered in formulating its estimate could change in the near term due to one or more future confirming events. Accordingly, actual results could differ from those estimates.
    Premiums Receivable, Allowance for Doubtful Accounts, Estimation Methodology, Policy [Policy Text Block]

    Accounts Receivable and Allowance for Doubtful Accounts

     

    Accounts receivable were reported at realizable value, net of allowances for doubtful accounts, which were estimated and recorded in the period the related revenue was recorded. The Company estimated and reviewed the collectability of its receivables based on a number of factors, including the period they were outstanding. Historical collection and payer reimbursement experience was an integral part of the estimation process related to allowances for doubtful accounts associated with Adeona Clinical Laboratory. In addition, the Company regularly assessed the state of its billing operations in order to identify issues, which impacted the collectability of these receivables or reserve estimates. Revisions to the allowances for doubtful accounts estimates were recorded as an adjustment to bad debt expense. Receivables deemed uncollectible were charged against the allowance for doubtful accounts.
    Revenue Recognition, Policy [Policy Text Block]

    Revenue Recognition

     

    The Company records revenue when all of the following have occurred: (1) persuasive evidence of an arrangement exists, (2) the service is completed without further obligation, (3) the sales price to the customer is fixed or determinable, and (4) collectability is reasonably assured.  The Company recognizes milestone payments or upfront payments that have no contingencies as revenue when payment is received.  For the year ended December 31, 2012 and 2011, the Company’s only stream of revenue was laboratory revenue.  Laboratory revenues are a component of discontinued operations for the years ended December 31, 2012 and 2011. See Note 3 – Discontinued Operations of Adeona Clinical Laboratory.

     

    License Revenues

     

    The Company’s licensing agreements may contain multiple elements, such as non-refundable up-front fees, payments related to the achievement of particular milestones and royalties. Fees associated with substantive at risk performance-based milestones are recognized as revenue upon completion of the scientific or regulatory event specified in the agreement. When the Company has substantive continuing performance obligations under an arrangement, revenue is recognized over the performance period of the obligations using a time-based proportional performance approach. Under the time-based method, revenue is recognized over the arrangement’s estimated performance period based on the elapsed time compared to the total estimated performance period. Revenue recognized at any point in time is limited to the amount of non-contingent payments received or due. When the Company has no substantive continuing performance obligations under an arrangement, it recognizes revenue as the related fees become due.

     

    Revenues from royalties on third-party sales of licensed technologies are generally recognized in accordance with the contract terms when the royalties can be reliably determined and collectibility is reasonably assured. To date, the Company has not received any royalty revenues.

     

    In 2010, the Company entered into the Meda Agreement for the development and commercialization of Effirma (oral flupirtine) for fibromyalgia.  As consideration for the sublicense, the Company received an up-front payment of $2.5 million upon execution of the Meda Agreement. This payment was recorded as license revenue in 2010. Pursuant to the Company’s license agreement with McLean Hospital, the Company paid 15% of the $2.5 million payment ($375,000), that was netted against the revenues received from Meda AB. The Company is also entitled to additional milestone payments of $5 million upon filing of an NDA with the U.S. FDA for oral flupirtine for fibromyalgia and $10 million upon marketing approval. The Meda Agreement also provides that the Company is entitled to receive net royalties of 7% of net sales of oral flupirtine approved for the treatment of fibromyalgia covered by issued patent claims in the U.S. and Japan. The Meda Agreement provides that Meda AB will assume all future development costs for the commercialization of oral flupirtine for fibromyalgia. Pursuant to the terms of the Company’s agreement with McLean Hospital, the Company is obligated to pay half of all future royalties the Company receives.  Future milestone payments will be recorded as revenue when payment is received as there are no future deliverables, and it is non-refundable.

     

    Laboratory Revenues

     

    The Company primarily recognized revenue for services rendered upon completion of the testing process. Billing for services reimbursed by third-party payers, including Medicare and Medicaid, were recorded as revenues, net of allowances for differences between amounts billed and the estimated receipts from such payers.

     

    The Company maintained a sales allowance to compensate for the difference in its billing practices and insurance company reimbursements. In determining this allowance, the Company looked at several factors, the most significant of which was the average difference between the amount charged and the amount reimbursed by insurance carriers over the prior 12 months, otherwise known as the yearly average adjustment amount. The allowance taken was the averaged yearly average adjustment amount for these prior period multiplied by the period’s actual gross sales to determine the actual sales allowance for each period. See Note 3 - Discontinued Operations of Adeona Clinical Laboratory.
    Risks and Uncertainties [Policy Text Block]

    Risks and Uncertainties

     

    The Company's operations could be subject to significant risks and uncertainties including financial, operational and regulatory risks and the potential risk of business failure. The global economic crisis has caused a general tightening in the credit markets, lower levels of liquidity, increases in the rates of default and bankruptcy, and extreme volatility in credit, equity and fixed income markets. These conditions may not only limit our access to capital, but also make it difficult for our customers, our vendors and us to accurately forecast and plan future business activities.
    Cash and Cash Equivalents, Policy [Policy Text Block]

    Cash and Cash Equivalents

     

    Cash and cash equivalents include cash and highly liquid short-term investments with original maturities of three months or less.
    Marketable Securities Held To Maturity Trading Available For Sale Securities Policy [Policy Text Block]

    Classification of Marketable Securities as Held to Maturity, Trading, and Available for Sale

     

    The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and reevaluates such determinations at each balance sheet date. Debt securities are classified as held to maturity when the Company has the positive intent and ability to hold the securities to maturity. Debt securities for which the Company does not have the intent or ability to hold to maturity are classified as available for sale. Held to maturity securities are recorded as either short-term or long-term on the balance sheet, based on contractual maturity date and are stated at amortized cost. Marketable securities that are bought and held principally for the purpose of selling them in the near term are classified as trading securities and are reported at fair value, with unrealized gains and losses recognized in earnings. Debt and marketable equity securities not classified as held to maturity or as trading, are classified as available for sale, and are carried at fair market value, with the unrealized gains and losses, net of tax, included in the determination of comprehensive income and reported in shareholders’ equity. At December 31, 2012 and 2011, respectively, the Company had no debt and marketable equity securities.

     

    During the year ended December 31, 2011, the Company held investments in marketable securities that were classified as held to maturity and consisted of corporate bonds and certificates of deposits as follows (in thousands) :

     

      December 31, 2011 
    Purchase of short-term investments $(4,370)
    Amortization of premium on investments  57 
    Proceeds from short-term investments  4,293 
    Loss on sale of short-term investments  20 
    Fair value $- 
    Property, Plant and Equipment, Policy [Policy Text Block]

    Property and Equipment

     

    Property and equipment is recorded at cost and depreciated or amortized using the straight-line method over the estimated useful life of the asset or the underlying lease term for leasehold improvements, whichever is shorter. The estimated useful life by asset description is noted in the following table.

     

    Asset Description   Estimated Useful Life
    Office equipment and furniture   3-5  years
    Laboratory equipment   7-10 years
    Manufacturing equipment   10 years
    Leasehold improvements and fixtures   Lesser of estimated useful or life of lease

     

    Depreciation expense was approximately $63,000 and $144,000 for the years ended December 31, 2012 and 2011, respectively. When assets are disposed of, the cost and accumulated depreciation are removed from the accounts. Repairs and maintenance are charged to expense as incurred.

     

    During 2012, the Company reviewed property and equipment for impairment and determined that certain items were impaired due to obsolescence. As a result of this review, the Company recorded an impairment loss of approximately $47,000. For the year ended December 31, 2011, there were no significant events or changes in circumstances identified by the Company that would indicate that the carrying value of an asset was not recoverable.
    Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block]

    Long-Lived Assets

     

    The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such an event or change in circumstances occurs and potential impairment is indicated because the carrying values exceed the estimated future undiscounted cash flows of the asset, the Company will measure the impairment loss as the amount by which the carrying value of the asset exceeds its fair value.
    Goodwill and Intangible Assets, Goodwill, Policy [Policy Text Block]

    Goodwill

     

    Goodwill was not amortized, and was tested for impairment at the reporting unit level annually and in interim periods if certain events occur indicating that the carrying value of goodwill was impaired. A reporting unit was an operating segment for which discrete financial information was available and was regularly reviewed by management. The Company had one reporting unit, Adeona Clinical Laboratory, to which goodwill was assigned.

     

    ASC No. 350, “Intangibles – Goodwill and Others,” requires a two-step approach to test goodwill for impairment for each reporting unit. The first step tests for impairment by applying fair value-based tests to a reporting unit. The second step, if deemed necessary, measures the impairment by applying fair value-based tests to specific assets and liabilities within the reporting unit. Application of the goodwill impairment tests require judgment, including identification of reporting units, assignment of assets and liabilities to each reporting unit, assignment of goodwill to each reporting unit, and determination of the fair value of each reporting unit. The determination of fair value for a reporting unit could be materially affected by changes in these estimates and assumptions.

     

    At December 31, 2011, in connection with the Company classifying Adeona Clinical Laboratory as discontinued operations, previously recorded goodwill was considered impaired. See Note 3 – Discontinued Operations of Adeona Clinical Laboratory.
    Derivatives, Reporting of Derivative Activity [Policy Text Block]

    Derivative Liabilities

     

    Once determined, derivative liabilities are adjusted to reflect fair value at each reporting period end, with any increase or decrease in the fair value being recorded in results of operations as an adjustment to fair value of derivatives. In addition, the fair value of freestanding derivative instruments such as warrants, are also valued using the Black-Scholes option pricing model.
    Earnings Per Share, Policy [Policy Text Block]

    Net Income (Loss) per Share

     

    Net income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding. Diluted income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding including the effect of common share equivalents. All common equivalent shares were anti-dilutive, at December 31, 2012 and December 31, 2011, as such there is no separate computation for diluted loss per share. The number of options and warrants for the purchase of common stock, that were excluded from the computations of net loss per common share for the year ended December 31, 2012 were 4,453,746 and 1,632,501, respectively, and for the year ended December 31, 2011 were 2,979,010 and 3,259,186, respectively.
    Research and Development Expense, Policy [Policy Text Block]

    Research and Development Costs

     

    The Company expenses research and development costs associated with developmental products not yet approved by the FDA to research and development expense as incurred. Research and development costs consist primarily of license fees (including upfront payments), milestone payments, manufacturing costs, salaries, stock-based compensation and related personnel costs, fees paid to consultants and outside service providers for laboratory development, legal expenses resulting from intellectual property prosecution and other expenses relating to the design, development, testing and enhancement of the Company’s product candidates.
    Fair Value of Financial Instruments, Policy [Policy Text Block]

    Fair Value of Financial Instruments

     

    The fair value accounting standards define fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is determined based upon assumptions that market participants would use in pricing an asset or liability. Fair value measurements are rated on a three-tier hierarchy as follows:

     

      · Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets;

     

      · Level 2 inputs: Inputs, other than quoted prices included in Level 1 that are observable either directly or indirectly; and

     

      · Level 3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions.

     

    In many cases, a valuation technique used to measure fair value includes inputs from multiple levels of the fair value hierarchy described above. The lowest level of significant input determines the placement of the entire fair value measurement in the hierarchy.

     

    The carrying amounts of the Company’s short-term financial instruments, including cash and cash equivalents, accounts receivable, other current assets, accounts payable and accrued liabilities, approximate fair value due to the relatively short period to maturity for these instruments.

     

    Cash and cash equivalents include money market accounts and mutual funds of $8.6 million and $5.0 million as of December 31, 2012 and December 31, 2011, respectively, that are measured using Level 1 inputs.
    Stock Based Payment Arrangements [Policy Text Block]

    Stock-Based Payment Arrangements

     

    Generally, all forms of stock-based payments, including stock option grants, warrants, restricted stock grants and stock appreciation rights are measured at their fair value on the awards’ grant date typically using a Black-Scholes pricing model, based on the estimated number of awards that are ultimately expected to vest. Stock-based compensation awards issued to non-employees for services rendered are recorded at either the fair value of the services rendered or the fair value of the stock-based payment, whichever is more readily determinable. The expense resulting from stock-based payments is recorded in research and development expense or general and administrative expense in the consolidated statement of operations, depending on the nature of the services provided.
    Income Tax, Policy [Policy Text Block]

    Income Taxes

     

    The Company accounts for income taxes in accordance with accounting guidance now codified as FASB ASC Topic 740, “Income Taxes,” which requires that the Company recognize deferred tax liabilities and assets based on the differences between the financial statement carrying amounts and the tax bases of assets and liabilities, using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit (expense) results from the change in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all deferred tax assets will not be realized.

     

    In addition, accounting guidance now codified as FASB ASC Topic 740-20, “Income Taxes – Intraperiod Tax Allocation” requires management to assess the need to accrue or disclose uncertain tax positions for proposed potential adjustments from various federal and state authorities who regularly audit the Company in the normal course of business. In making these assessments, management must often analyze complex tax laws of multiple jurisdictions. The accounting guidance prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company records the related interest expense and penalties, if any, as tax expense in the tax provision. At December 31, 2012 and 2011, respectively, the Company did not record any liabilities for uncertain tax positions.
    New Accounting Pronouncements, Policy [Policy Text Block]

    Recent Accounting Pronouncements

     

    There were no accounting standards or interpretations issued or recently adopted that are expected to have a material impact on the Company’s financial position, operations, or cash flows.
    XML 70 R15.htm IDEA: XBRL DOCUMENT v2.4.0.6
    License, Collaborative and Employment Agreements and Commitments
    		 12 Months Ended
    Dec. 31, 2012
    Disclosure Of License Collaborative and Employment Agreements and Commitments [Abstract]  
    License Collaborative and Employment Agreements and Commitments [Text Block]
    7. License, Collaborative and Employment Agreements and Commitments

     

    License and Collaborative Agreements

     

    As described below, the Company has entered into several license and collaborative agreements for the right to use research, technology and patents. Some of these license and collaborative agreements may contain milestones.  The specific timing of such milestones cannot be predicted and are dependent on future developments as well as regulatory actions which cannot be predicted with certainty (including actions which may never occur).  Further, under the terms of certain licensing agreements, the Company may have the obligation to pay certain milestones contingent upon the achievement of specific levels of sales.  Due to the long-range nature of such commercial milestone amounts, they are neither probable at this time nor predictable and consequently are not included in this disclosure.

     

    On December 19, 2012, the Company entered into a License Agreement with The University of Texas at Austin (the “University”) for the exclusive license of the right to use, develop, manufacture, market and commercialize certain research and patents related to pertussis antibodies. The License Agreement provides that the University is entitled to payment of past patent expenses, an annual payment of $50,000 per year commencing on the effective date through December 31, 2014 and a $25,000 payment on December 31, 2015 and milestone payments of $50,000 upon commencement of Phase I clinical trials, $100,000 upon commencement of Phase III clinical trials, $250,000 upon NDA submission in the U.S., $100,000 upon European Medicines Agency approval and $100,000 upon regulatory approval in an Asian country. In addition, the University is entitled to a running royalty upon net sales (as defined in the License Agreement). The License Agreement terminates upon the expiration of the patent rights (as defined in the License Agreement); provided, however that the License Agreement is subject to early termination by the Company in its discretion and by the University for a breach of the License Agreement by the Company.

     

    In connection with the License Agreement, the Company and the University also entered into a Sponsored Research Agreement pursuant to which the University will perform certain research work related to pertussis. The Sponsored Research Agreement may be renewed annually, in the sole discretion of the Company, after the first year for two additional one year terms with a fixed fee for the first year of $303,287 and for the second and third years, if renewed, a fixed fee of $316,438 and $328,758 respectively, all payable in quarterly installments. If renewed by the Company after the first year for the remaining two years, the research shall be performed from the effective date of the Sponsored Research Agreement until December 31, 2015; provided, however, the Sponsored Research Agreement is subject to early termination upon the written agreement of the parties, a default in the material obligations under the Research Agreement which remain uncured for sixty days after receipt of notice, automatically upon the Company’s bankruptcy or insolvency and by the Company in its sole discretion at any time after the one year anniversary of the date of execution thereof upon no less than 90 days notice. Upon termination prior to December 31, 2014, the Company shall only be responsible for payment of expenses that do not exceed the fixed annual amount and are incurred prior to the termination date and non-cancellable expenses committed to be expended by the University prior to the termination date for the lesser of the remainder of their appointment in the case of salaries and December 31, 2014. Upon a termination after December 31, 2014 or due to a breach by the University, the Company shall only be responsible for all reasonable expenses that do not exceed the fixed annual amount and that are incurred by the University prior to the termination date for services performed prior to the termination date.

     

    On November 28, 2012, a closing was held for the transaction contemplated by the Prev Agreement the Company entered into with Prev ABR LLC (“Prev”), pursuant to which it acquired the C. diff program assets of Prev, including pre-Investigational New Drug (IND) package, Phase I and Phase II clinical data, manufacturing process data and all issued and pending U.S. and international patents.  Pursuant to the Prev Agreement, the Company paid Prev an initial cash payment of $100,000 upon execution of the Prev Agreement and at closing paid an additional cash payment of $135,000 and issued 625,000 unregistered shares of our common stock to Prev. See Note 6. In addition, upon the achievement of the milestones set forth below, Prev may be entitled to receive additional consideration payable 50% in cash and 50% in our stock, subject to Prev’s option to receive the entire payment in shares of our stock, with the exception of the first milestone payments to be paid in cash: (i) upon commencement of an IND; (ii) upon commencement of a Phase I clinical trial; (iii) upon commencement of a Phase II clinical trial; (iv) upon commencement of a Phase III clinical trial; (v) upon Biologic License Application (BLA) filing in the U.S. and for territories outside of the U.S. (as defined in the Prev Agreement); and (vi) upon BLA approval in the U.S. and upon approval in territories outside the-U.S. The Prev Agreement also provides that Prev has a right to the return to it of all assets acquired by the Company under the Prev Agreement if on or prior to the date that is (i) thirty (30) months after the execution of the Prev Agreement, the Company has not initiated toxicology studies in non-rodent models or (ii) thirty six (36) months have not filed an IND under the program related to the assets and such failure is not due to action or inaction of Prev or breach of its representations or warranties or covenants or if there is a change of control as defined in the Prev Agreement and after such change of control the assets are not further developed; provided however that such thirty (30) and thirty six (36) month periods can be extended by the Company for an additional twelve (12) months upon payment of a cash milestone payment.

     

    On August 6, 2012, the Company expanded its relationship with Intrexon and entered into the Second Channel Agreement with Intrexon that governs an “exclusive channel collaboration” arrangement in which the Company will use Intrexon’s technology relating to the identification, design and production of human antibodies and DNA vectors for the development and commercialization of a series of monoclonal antibody therapies for the treatment of certain serious infectious diseases. Pursuant to the terms of the Second Stock Issuance Agreement with Intrexon, which was approved by the Company’s stockholders on October 5, 2012, the Company issued 3,552,210 shares of its common stock, $0.001 par value, which issuance is also deemed paid in consideration for the execution and delivery of the Second Channel Agreement, dated August 6, 2012, between the Company and Intrexon. The fair value of this transaction was $7.8 million and was charged to research and development expense for the year ended December 31, 2012, in accordance with the Company’s accounting policy. In connection with the transactions contemplated by the Second Stock Issuance Agreement, and pursuant to the First Amendment to Registration Rights Agreement (the “First Amendment to Registration Rights Agreement”) executed and delivered by the parties at the closing, the Company agreed to file a “resale” registration statement registering the resale of certain of the shares issued under the Second Stock Issuance Agreement. None of the shares to be issued under the Second Stock Issuance Agreement need to be registered until April 30, 2013. Under that agreement, the Company is obligated to use its reasonable best efforts to cause the “resale” registration statement to be declared effective as promptly as practicable after filing and to maintain the effectiveness of the registration statement until all securities therein are sold or are otherwise can be sold pursuant to Rule 144, without any restrictions.

     

    Subject to certain expense allocations and other offsets provided in the Second Channel Agreement, the Company will pay Intrexon royalties on annual net sales of the Synthetic Products, calculated on a Synthetic Product-by-Synthetic Product basis. The Company has likewise agreed to pay Intrexon a percentage of quarterly revenue obtained from a sublicensor in the event of a sublicensing arrangement.

     

    The Company also agreed upon the filing of an Investigational New Drug application with the U.S. Food and Drug Administration for a Synthetic Product, or alternatively the filing of the first equivalent regulatory filing with a foreign regulatory agency (both as applicable, the “IND Milestone Event”), to pay Intrexon either (i) two million dollars ($2M) in cash, or (ii) that number of shares of Common Stock (the “IND Milestone Shares”) having a fair market value equaling two million dollars ($2M) where such fair market value is determined using published market data of the share price for Common Stock at the close of market on the business day immediately preceding the date of public announcement of attainment of the IND Milestone Event.

     

    Upon the first to occur of either first commercial sale of a Synthetic Product in a country or the granting of the regulatory approval of that Synthetic Product (both as applicable, the “Approval Milestone Event”), the Company agreed to pay to Intrexon either (i) three million dollars ($3M) in cash, or (ii) that number of shares of Common Stock (the “Approval Milestone Shares”) having a fair market value equaling three million dollars ($3M) where such fair market value is determined using published market data of the share price for Common Stock at the close of market on the business day immediately preceding the date of public announcement of attainment of the Approval Milestone Event.

     

    The Company also agreed that it will pay an optional and varying fee whereby the Company remits a payment, in cash or equity at our sole discretion, to Intrexon calculated as a multiple of the number of targets in excess of three (3) total that the Company desires to elect (the “Field Expansion Fee”). The Field Expansion Fee must be paid completely in either Common Stock or cash, and will comprise either (i) two million dollars ($2M) in cash for each target in excess of three (3) total that the Company elects, or (ii) that number of shares of Common Stock (the “Field Expansion Fee Shares”) having a fair market value equaling two million dollars ($2M) for each such target that the Company elects in excess of three where such fair market value is determined using published market data establishing the volume-weighted average price for a share of Common Stock over the thirty (30) day period immediately preceding the date of the Field Expansion Fee Closing.

     

    On November 18, 2011, the Company entered into the Initial Channel Agreement with Intrexon that governs an “exclusive channel collaboration” arrangement in which the Company initially intended to use Intrexon’s technology directed towards the production of PGIS. As consideration for execution of the Initial Channel Agreement, the Company entered into the Initial Stock Purchase Agreement with Intrexon pursuant to which the Company issued to Intrexon a number of shares of our common stock equal to 9.995% of the number of shares of the Company’s common stock issued and outstanding following and giving effect to such issuance at a purchase price equal to the $0.001 par value of such shares, which issuance was deemed paid in consideration for the execution and delivery of the Initial Channel Agreement. The Company also agreed to issue additional shares of its common stock to Intrexon upon dosing of the first patient in a Phase II clinical trial sponsored by the Company in the U.S., or similar study as the parties may agree in a country other than the U.S. The program under this Initial Channel Agreement is in the discovery stage. In connection with the transactions contemplated by the Stock Purchase Agreement, and pursuant to the Registration Rights Agreement executed and delivered by the Company to Intrexon, the Company agreed to file a “resale” registration statement registering the resale of the First Tranche Shares within 120 days of the closing date of such issuance. The registration statement registering such shares was declared effective on April 13, 2012, but is not currently valid due to certain issues regarding the failure of the Company’s prior auditor to follow proper partner rotation. Intrexon has agreed not to require the Company to file a post effective registration statement on Form S-1 with respect to the First Tranche Shares and instead has agreed to wait until the Company is once again S-3 eligible for registration of such shares.

     

    The Company paid Intrexon a prepayment of research and development expenses of $2.5 million for research and development goods and services to be provided in the future and has been recorded on the Company’s balance sheet in prepaid expenses and other current assets.

      

    In September of 2005, the Company entered into a three-year research agreement with the University of Michigan. Pursuant to that agreement, the Company sponsored research of approximately $460,000 per year.  On March 20, 2008, the Company terminated the agreement.  On March 24, 2009, the Company entered into a payment plan with the University of Michigan to pay the outstanding balance of $197,000.  The Company agreed to pay $5,000 per month, the balance was paid in full July 2012.

     

    Employment Agreements

     

    Effective February 3, 2012, Dr. Kuo resigned from his positions as President and Chief Executive Officer. In connection with his resignation, Dr. Kuo entered into a nine-month consulting agreement with the Company (the “Consulting Agreement”). Pursuant to the Consulting Agreement, Dr. Kuo will be entitled to a consulting fee of $17,000 per month and retain the right to exercise the stock options held by him that have vested (324,999) as of the effective date of the Consulting Agreement for a period expiring on the date that is one year from the effective date of the Consulting Agreement.

     

    Effective February 3, 2012, Jeffrey Riley was appointed to serve as the Company’s Chief Executive Officer and President. In connection with his appointment, Mr. Riley entered into a three-year employment agreement with the Company (the “Riley Employment Agreement”). Pursuant to the Riley Employment Agreement, Mr. Riley will be entitled to an annual base salary of $348,000 and will be eligible for discretionary performance and transactional bonus payments. Additionally, Mr. Riley was granted options to purchase 750,000 shares of the Company’s common stock with an exercise price equal to the per share market price on the date of issue. These options will vest pro rata, on a monthly basis, over thirty-six months. The Company measured the fair value of the stock options at approximately $1.7 million using a Black-Scholes valuation model.

     

    Effective February 6, 2012, C. Evan Ballantyne was appointed the Company’s Chief Financial Officer. In connection with his appointment, Mr. Ballantyne entered into a three-year employment agreement with the Company (the “Ballantyne Employment Agreement”). Pursuant to the Ballantyne Employment Agreement, Mr. Ballantyne will be entitled to an annual base salary of $298,000 and will be eligible for discretionary performance and transactional bonus payments. Additionally, Mr. Ballantyne was granted options to purchase 425,000 shares of our common stock with an exercise price equal to our per share market price on the date of issue. These options will vest pro rata, on a monthly basis, over thirty-six months. The Company measured the fair value of the stock options at approximately $1 million using a Black-Scholes valuation model.

     

    Other Commitments

     

    As of December 31, 2012, amounts due for license and sponsored research agreements are as follows (in thousands):

     

    Year Ending December 31,        
    2013   $ 287  
    2014     60  
    2015     35  
    2016     10  
    2017     10  
    Total   $ 402  

      

    Operating Lease

     

    During 2012, the Company entered into a one year operating lease for office space in Ann Arbor, Michigan.  In March 2013, this lease was amended to extend the term of the lease to December 31, 2014, for annual lease payments of $33,000. In March 2012, the Company also entered into a one year operating lease that may be renewed for two additional terms of one year, for office space in Rockville, Maryland, for annual lease payments of $35,000. The Maryland office lease may be terminated with 60 days written notice.

     

    During the years ended December 31, 2012 and 2011, the Company recognized rent expense of $123,000 and $64,000, respectively.
    XML 71 R13.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Stock-Based Compensation
    		 12 Months Ended
    Dec. 31, 2012
    Disclosure Of Compensation Related Costs, Share-Based Payments [Abstract]  
    Disclosure of Compensation Related Costs, Share-based Payments [Text Block]
    5. Stock-Based Compensation

     

    Stock Incentive Plan

     

    During 2001, the Company’s Board of Directors and stockholders adopted the 2001 Stock Incentive Plan (the “2001 Stock Plan”). The total number of shares of stock with respect to which stock options and stock appreciation rights may be granted to any one employee of the Company or a subsidiary during any one-year period under the 2001 Stock Plan shall not exceed 250,000. All awards pursuant to the 2001 Stock Plan shall terminate upon the termination of the grantee’s employment for any reason. Awards include options, restricted shares, stock appreciation rights, performance shares and cash-based awards (the “Awards”). The 2001 Stock Plan contains certain anti-dilution provisions in the event of a stock split, stock dividend or other capital adjustment, as defined in the plan. The 2001 Stock Plan provides for a Committee of the Board to grant awards and to determine the exercise price, vesting term, expiration date and all other terms and conditions of the awards, including acceleration of the vesting of an award at any time. As of December 31, 2012, there were 1,066,007 options issued and outstanding under the 2001 Stock Plan.

    On March 20, 2007, the Company’s Board of Directors approved the 2007 Stock Incentive Plan (the “2007 Stock Plan”) for the issuance of up to 2,500,000 shares of common stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. This plan was approved by stockholders on November 2, 2007. The exercise price of stock options under the 2007 Stock Plan is determined by the compensation committee of the Board of Directors, and may be equal to or greater than the fair market value of the Company’s common stock on the date the option is granted. The total number of shares of stock with respect to which stock options and stock appreciation rights may be granted to any one employee of the Company or a subsidiary during any one-year period under the 2007 plan shall not exceed 250,000. Options become exercisable over various periods from the date of grant, and generally expire ten years after the grant date. As of December 31, 2012, there are 872,739 options issued and outstanding under the 2007 Stock Plan.

     

    On November 2, 2010, the Board of Directors and stockholders adopted the 2010 Stock Incentive Plan (“2010 Stock Plan”) for the issuance of up to 3,000,000 shares of common stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. The exercise price of stock options under the 2010 Stock Plan is determined by the compensation committee of the Board of Directors, and may be equal to or greater than the fair market value of the Company’s common stock on the date the option is granted. Options become exercisable over various period from the date of grant, and generally expire ten years after the grant date. As of December 31, 2012, there are 2,515,000 options issued and outstanding under the 2010 Stock Plan.

     

    In the event of an employee’s termination, the Company will cease to recognize compensation expense for that employee. There is no deferred compensation recorded upon initial grant date, instead, the fair value of the stock-based payment is recognized ratably over the stated vesting period.

     

    The Company has applied fair value accounting for all share based payment awards since inception. The fair value of each option or warrant granted is estimated on the date of grant using the Black-Scholes option pricing model. The Black-Scholes assumptions used in the years ended December 31, 2012 and 2011 are as follows:

     

        Year ended December 31,
        2012   2011
    Exercise price   $1.69 - $2.47   $0.49 - $2.22
    Expected dividends   0%   0%
    Expected volatility   108% - 174%   175% - 188%
    Risk fee interest rate   0.37% - 1.98%   1.30% - 3.58%
    Expected life of option   5 - 10 years   5 - 7 years
    Expected forfeitures   0%   0%

     

    The Company records stock-based compensation based upon the stated vested provisions in the related agreements. The vesting provisions for these agreements have various terms as follows:

     

      · immediate vesting,
      · half vesting immediately and the remainder over three years,
      · quarterly over three years,
      · annually over three years,
      · one-third immediate vesting and remaining annually over two years,
      · one half immediate vesting with remaining vesting over nine months,
      · one quarter immediate vesting with the remaining over three years
      · one quarter immediate vesting with the remaining over 33 months; and
      · monthly over three years.

     

    During 2012, the Company granted 2,075,000 options to employees and consultants having an approximate fair value of $4.5 million based upon the Black-Scholes option pricing model.  During 2011, the Company granted 557,002 options to employees and consultants having an approximate fair value of $609,000 based upon the Black-Scholes option pricing model.

     

    Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued employees for the years ended December 31, 2012 and 2011 were $1.4 million and $268,000, respectively. Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued to consultants for the years ended December 31, 2012 and 2011 were $216,000 and $705,000, respectively.

      

                    Weighted        
                    Average        
              Weighted     Remaining     Aggregate  
              Average Exercise     Contractual     Intrinsic  
        Options     Price     Life     Value  
    Balance – December 31, 2010     2,539,091     $ 1.32       6.97 years     $ 1,028,000  
    Granted     557,002     $ 1.26                  
    Exercised     (23,333 )   $ 0.57                  
    Forfeited     (93,750 )   $ 0.59                  
    Balance – December 31, 2011     2,979,010     $ 1.34       6.01 years     $ -  
    Granted     2,075,000     $ 2.21                  
    Exercised     (374,851 )   $ 0.34                  
    Forfeited     (225,413 )   $ 2.37                  
    Balance – December 31, 2012 – outstanding     4,453,746     $ 1.78       6.43 years     $ 1,308,000  
    Balance – December 31, 2012 – exercisable     2,891,877     $ 1.60       5.71 years     $ 1,160,000  
                                     
    Grant date fair value of options granted – 2012           $ 4,467,984                  
    Weighted average grant date fair value – 2012           $ 2.15                  
    Grant date fair value of options granted – 2011           $ 609,000                  
    Weighted average grant date fair value – 2011           $ 1.09                  

      

    The options outstanding and exercisable at December 31, 2012 are as follows:

     

    Options Outstanding   Options Exercisable
              Weighted     Weighted Average         Weighted     Weighted Average
    Range of         Average     Remaining         Average     Remaining
    Exercise Price   Options     Exercise Price     Contractual Life   Options     Exercise Price     Contractual Life
    $0.09 - $2.00     2,162,362     $ 1.78     5.76 years     1,801,187     $ 1.14     5.52 years
    $2.01 - $3.00     2,212,227       2.26     7.15 years     1,011,533       2.17     6.14 years
    $3.01 - $6.00     79,157       4.87     4.49 years     79,157       4.87     4.49 years
    $0.09 - $6.00     4,453,746     $ 1.78     6.43 years     2,891,877     $ 1.60     5.71 years

     

    The options outstanding and exercisable at December 31, 2011 are as follows:

     

    Options Outstanding   Options Exercisable
              Weighted     Weighted Average         Weighted     Weighted Average
    Range of         Average     Remaining         Average     Remaining
    Exercise Price   Options     Exercise Price     Contractual Life   Options     Exercise Price     Contractual Life
    $0.09 - $4.57     2,889,011     $ 1.20     6.11 years     2,364,608     $ 1.29     5.72 years
    $4.58 - $9.05     89,999       5.93     2.76 years     89,999       5.93     2.76 years
    $0.09 - $9.05     2,979,010     $ 1.34     6.01 years     2,454,607     $ 1.46     5.62 years

     

    The following is a summary of the Company’s non-vested stock options at December 31, 2012:

     

              Weighted Average  
        Unvested     Grant  
        Stock Options     Date Fair Value  
    Non-vested – December 31, 2011     524,403     $ 0.82  
    Granted     2,075,000       2.21  
    Vested/Exercised     (891,332 )     0.81  
    Forfeited/Cancelled     (146,202 )     1.79  
    Non-vested – December 31, 2012     1,561,869     $ 2.11  
    Weighted average remaining period for vesting     2.09 years          

     

    As of December 31, 2012, total unrecognized stock-based compensation expense related to stock options was $3.2 million, which is expected to be expensed through September 2015.

     

    FASB’s guidance for stock-based payments requires cash flows from excess tax benefits to be classified as a part of cash flows from financing activities.  Excess tax benefits are realized tax benefits from tax deductions for exercised options in excess of the deferred tax asset attributable to stock compensation costs for such options.  The Company did not record any excess tax benefits in 2012 or 2011.  Cash received from option exercises under the Company’s stock-based compensation plans for the years ended December 31, 2012 and 2011 was $127,000 and $15,000, respectively.

     

    Stock Warrants and Derivative Liabilities

     

    On October 25, 2012, the Company entered into a Common Stock Purchase Agreement with certain accredited investors. As part of this agreement, the Company issued warrants to purchase 635,855 shares of common stock to the placement agent, or its permitted assigns. The warrants have an exercise price of $1.60 and a life of five years. The warrants vested immediately and expire October 25, 2017. Since these warrants were granted as part of an equity raise, the Company has treated them as a direct offering cost. The result of the transaction has no affect to equity. As of December 31, 2012, all the warrants were outstanding.

     

    On March 15, 2012, the Company entered into a consulting agreement for a financial communications program, for a period of twelve months that began on February 20, 2012. As compensation for such program, the consultant is paid a monthly fee and will be issued a performance warrant exercisable for 250,000 shares of the Company’s common stock based on achievement of certain stock price milestones. Upon initiation of the program, 50,000 of the performance warrants vested. The performance warrant is exercisable for a period of two years from the date of issuance for an exercise price equal to the price ($2.20 per share) of the Company’s common stock on the date of execution (March 15, 2012). The expense recorded for the year ended December 31, 2012 approximated $63,000 and was estimated using the Monte Carlo valuation model. The assumptions used by the Company are summarized in the following table:

     

    Exercise price   $ 2.20  
    Expected dividends     0 %
    Expected volatility     110 %
    Risk free interest rate     0.26 %
    Expected life of warrant     2 years  

     

    On December 20, 2011, the Company entered into a consulting agreement for financial advisory services, for a period of twelve months. As compensation for such services, the consultant is paid a monthly fee and on February 2, 2012, was issued a warrant exercisable for 100,000 shares of the Company’s common stock. The warrant is exercisable upon issuance for a period of five years from the date of issue at an exercise price equal to the price of the Company’s common stock on the date of issue. The fair value of the warrant approximated $200,000 and was measured using the Black-Scholes valuation model. All of this expense was recorded in the year ended December 31, 2012. The assumptions used by the Company are summarized in the following table:

     

    Exercise price   $ 1.14  
    Expected dividends     0 %
    Expected volatility     174 %
    Risk free interest rate     0.71 %
    Expected life of warrant     5 years  

     

    On January 28, 2011, the Company entered into a Common Stock Purchase Agreement with three institutional investors. As part of this agreement, the Company issued warrants to purchase 1,428,572 shares of common stock. Each warrant was exercisable for thirteen months at $2.00 per share and subsequently exchanged for new warrants with substantially the same terms as the original warrants except that the expiration date was extended for two months. The original warrants had an anti-dilution price protection feature; if the Company issues securities at a price per share that is less than $2.00 per share, the warrant holders will be ratcheted down to the lower offering price. However, the Company had instituted a floor price of $1.40 per share in connection with the price protection.

     

    On April 6, 2011, the Company entered into another Common Stock Purchase Agreement that triggered the ratchet provision and re-set the price of these warrants to $1.40 per share. Due to the re-set to the floor price, the warrant liability was marked-to-market and reclassified to additional paid-in capital since it ceased to contain the provisions of a derivative liability. As of December 31, 2012, all of these warrants have been exercised.

     

    The warrants were initially recorded as liabilities at their estimated fair value on the commitment date, which was $716,000 with subsequent changes in estimated fair value recorded as a warrant expense in the Company’s statement of operations at each subsequent reporting period. On April 6, 2011, the fair value of the warrant liability was $1.5 million, which represented an increase in fair value of $765,000. The fair value was measured using the Black-Scholes valuation model. The assumptions used by the Company are summarized in the following table:

     

              Remeasurement  
        Commitment     Date  
        Date     April 6, 2011  
    Closing stock price   $ 1.39     $ 2.08  
    Expected dividend rate     0 %     0 %
    Expected stock price volatility     117.1 %     104.6 %
    Risk free interest rate     0.28 %     0.29 %
    Expected life (years)     1.08       0.85  

     

    On August 10, 2011, the Company entered into an agreement to exchange the warrants issued in connection with the January 28, 2011 financing for new warrants with substantially the same terms as the original warrants except that in the new warrants the expiration date was extended by two months.

     

    On April 6, 2011, the Company entered into a Common Stock Purchase Agreement with an institutional investor. As part of this agreement, the Company issued a warrant to purchase 844,391 shares of common stock. The warrant was initially exercisable for thirteen months at $2.0725 per share. The warrant had an anti-dilution price protection feature; that provided if the Company issues securities at a price per share that is less than $2.0725 per share, the exercise price of the warrant will be ratcheted down to the lower offering price. On July 28, 2011, the warrant was exchanged for a new warrant with substantially similar terms except that in the new warrant (i) the anti-dilution price protection was eliminated, (ii) the exercise price was lowered to $1.00, (iii) the expiration date was extended for an additional three months to August 12, 2012, and (iv) the warrant’s initial exercise date was changed to January 2012. Due to this warrant exchange, the warrant liability was marked-to-market and reclassified to additional paid-in capital since it ceased to contain the provisions of a derivative liability. As of December 31, 2012, all of these warrants have been exercised.

     

    The warrant is initially recorded as a liability at its estimated fair value on the commitment date, which was $776,000 with subsequent changes in estimated fair value recorded as a warrant expense in the Company’s statement of operations at each subsequent period. On July 28, 2011, the fair value of the warrant liability was $253,000, which represented a decrease in fair value of $523,000. The fair value is measured using the Black-Scholes valuation model. The assumptions used by the Company are summarized in the following table:

     

              Remeasurement  
        Commitment     Date  
        Date     July 28, 2011  
    Closing stock price   $ 2.08     $ 0.84  
    Expected dividend rate     0 %     0 %
    Expected stock price volatility     112.1 %     105.6 %
    Risk free interest rate     0.29 %     0.21 %
    Expected life (years)     1.08       1.04  

     

    The following table summarizes the estimated fair value of the warrant liabilities at December 31, 2011(in thousands):

     

    Balance at December 31, 2010   $ -  
    Warrant liability     1,492  
    Change in fair value of warrant liability     242  
    Reclassification to additional paid-in capital     (1,734 )
    Balance at December 31, 2011   $ -  

     

    A summary of warrant activity for the Company for the year ended December 31, 2011 and for the year ended December 31, 2012 is as follows:

     

              Weighted Average  
        Number of Warrants     Exercise Price  
    Balance at December 31, 2010     1,131,078     $ 3.49  
    Granted     2,272,963       1.25  
    Exercised     (15,615 )     1.03  
    Forfeited     (129,240 )     2.08  
    Balance as December 31, 2011     3,259,186       1.95  
    Granted     985,855       1.71  
    Exercised     (1,768,167 )     1.11  
    Forfeited     (844,373 )     3.32  
    Balance as December 31, 2012     1,632,501     $ 1.99  

     

    Stock-based compensation expense included in general and administrative expenses relating to warrants issued to consultants for the year ended December 31, 2012 was $271,000. There was no stock-based compensation for warrants for the year ended December 31, 2011.

    A summary of all outstanding and exercisable warrants as of December 31, 2012 is as follows:

     

    Exercise
    Price    		     Warrants
    Outstanding    		     Warrants
    Exercisable    		     Weighted Average
    Remaining
    Contractual Life    		     Aggregate
    Intrinsic Value    		  
    $ 1.14       100,000       100,000       4.09 years     $ 62,000  
    $ 1.32       18,182       18,182       3.00 years     $ 8,000  
    $ 1.60       635,855       635,855       4.83 years     $ 102,000  
    $ 2.20       250,000       50,000       1.20 years     $    
    $ 2.22       517,257       517,257       3.91 years     $ -  
    $ 3.30       61,207       61,207       3.30 years     $ -  
    $ 3.75       50,000       50,000       3.13 years     $ -  
    $ 1.99       1,632,501       1,432,501       3.80 years     $ 172,000  

     

    Options of Subsidiary

     

    As of December 31, 2012, Epitope, a majority-owned subsidiary of Synthetic Biologics, has 50,000 stock options outstanding and 40,000 stock options exercisable. These stock options have an exercise price of $0.001 and a remaining contractual life of 5.50 years.
    XML 72 R14.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Stockholders' Equity
    		 12 Months Ended
    Dec. 31, 2012
    Stockholders' Equity Note [Abstract]  
    Stockholders' Equity Note Disclosure [Text Block]
    6. Stockholders’ Equity

     

    Year Ended December 31, 2011

     

    During the year ended December 31, 2011, the Company issued 28,333 shares of common stock in connection with the exercise of stock options and warrants for proceeds of $15,000 and 10,615 shares of common stock related to a cashless exercise of warrants. The Company issued 73,585 shares of common stock for employment service, having a fair value of $94,000 ($1.29 average per share) and 171,796 shares of common stock for consulting services, having a fair value of $165,000 ($0.96 average per share), based on the quoted closing trading prices. The Company also issued 3,123,558 shares of common stock as consideration for the Exclusive Channel Collaboration Agreement with Intrexon, having a fair value of $1.7 million ($0.54 per share), based on the quoted closing trading price.

     

    On January 28, 2011, the Company sold 2,857,144 shares of common stock and warrants exercisable for 1,428,572 shares of common stock for $4 million. Direct offering costs were approximately $296,000.

     

    On April 6, 2011, the Company sold 1,688,782 shares of common stock and a warrant exercisable for 844,391 shares of common stock for $3.5 million. Direct offering costs were approximately $243,000.

     

    Year Ended December 31, 2012

     

    On October 31, 2012, the Company completed a private placement financing of 6,750,000 shares of the Company’s common stock at a closing price of $1.60 for gross proceeds of $10.8 million.  The Company paid direct offering costs of $680,000.  See Note 5 regarding warrants granted with this offering.

     

    During the year ended December 31, 2012, the Company issued 374,851 shares of common stock, in connection with the exercise of stock options, for proceeds of approximately $127,000. The Company also issued 1,768,167 shares of common stock in connection with the exercise of warrants, for proceeds of approximately $2.0 million. The Company also issued 3,552,210 shares of common stock as consideration for a second Exclusive Channel Collaboration Agreement with Intrexon, having a fair value of $7.8 million ($2.20 per share), based on the quoted closing trading price. These shares are subject to the registration rights agreement as described in Note 7. In connection with the private placement that was completed on October 31, 2012, the Company also entered into an agreement with NRM VII Holdings I, LLC, an affiliate of Intrexon that acquired 3,125,000 shares of the Company’s common stock in the private placement, pursuant to which NRM VII Holdings I, LLC agreed to be bound by the terms of and join Intrexon as a party to its registration rights agreement as described in Note 7. In addition, the Company issued 625,000 shares of common stock as consideration for the acquisition of the C. diff program assets of Prev ABR LLC, having a fair value of $1.2 million ($1.87 per share), based on the quoted closing trading price.
    XML 73 R16.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Stock Repurchase Program
    		 12 Months Ended
    Dec. 31, 2012
    Stock Repurchase Program [Abstract]  
    Stock Repurchase Program [Text Block]
    8. Stock Repurchase Program

     

    On April 3, 2009, the Company’s Board of Directors approved a Stock Repurchase Program authorizing the Company to repurchase, from time-to-time and through December 31, 2009, up to $1 million of its common stock, up to a maximum of four million shares at prices of up to $5 per share. As of December 31, 2012, the Company had repurchased 81,482 shares for approximately $50,000 ($0.61 per share), based upon the quoted closing trading price.  These treasury shares are not included in the computation of earnings (loss) per share and are deemed to be canceled and retired.
    XML 74 R34.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Selected Balance Sheet Information (Details 1) (USD $)
    In Thousands, unless otherwise specified
    Dec. 31, 2012
    Dec. 31, 2011
    Intrexon prepaid research and development expenses $ 2,412 $ 0
    Other receivables 17 0
    Prepaid expenses 80 16
    Total $ 2,509 $ 16
    XML 75 R51.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Income Taxes (Details) (USD $)
    In Thousands, unless otherwise specified
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Computed ''expected" tax benefit - Federal $ (5,803) $ (2,618)
    Computed "expected" tax benefit - State (676) (448)
    Meals, entertainment and other 5 5
    Non-deductible stock-based compensation 518 366
    Warrant expense 0 562
    Change in fair value of warrant expense 0 91
    Realized loss on debt securities 0 7
    Change in valuation allowance 5,956 2,035
    Expected tax expense $ 0 $ 0
    XML 76 R21.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Discontinued Operations of Adeona Clinical Laboratory and Note Receivable (Tables)
    		 12 Months Ended
    Dec. 31, 2012
    Discontinued Operations and Disposal Groups [Abstract]  
    Schedule of Disposal Groups Including Discontinued Operations Balance Sheet and Additional Disclosures [Table Text Block]
    The assets of the discontinued operations are presented separately under the caption “Assets of discontinued operations” in the accompanying Consolidated Balance Sheets at December 31, 2012, and December 31, 2011, and consist of the following (in thousands):

     

        December 31,  
        2012     2011  
    Assets of discontinued operations:            
    Property and equipment, net   $ -     $ 23  
    Total assets   $ -     $ 23  
    Schedule of Disposal Groups Including Discontinued Operations Income Statement and Additional Disclosures [Table Text Block]

    The summarized statement of operations data for Adeona Clinical Laboratory for the years ended December 31, 2012 and December 31, 2011 are as follows (in thousands):

     

        December 31,  
        2012     2011  
    Laboratory fees, net   $ 115     $ 1,169  
                     
    Operating Costs and Expenses:                
    General and administrative     466       539  
    Cost of  laboratory services     110       975  
    Impairment loss on goodwill     -       178  
    Total operating costs and expenses     576       1,692  
    Loss from discontinued operations     (461 )     (523 )
                     
    Other Income:                
    Gain on sale of Adeona Clinical Laboratory     677       -  
    Income (loss) from discontinued operations   $ 216     $ (523 )
    XML 77 R26.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Organization and Nature of Operations and Basis of Presentation (Details Textual) (USD $)
    Dec. 31, 2012
    Notes Payable $ 700,000
    XML 78 R49.htm IDEA: XBRL DOCUMENT v2.4.0.6
    License, Collaborative and Employment Agreements and Commitments (Details Textual) (USD $)
    		 12 Months Ended 12 Months Ended 12 Months Ended 24 Months Ended 12 Months Ended 1 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Dec. 31, 2009
    Dec. 31, 2012
    First Year [Member]
    Dec. 31, 2012
    Second Year [Member]
    Dec. 31, 2012
    Third Year [Member]
    Dec. 31, 2012
    Ind Milestone Event [Member]
    Dec. 31, 2012
    Approval Milestone Event [Member]
    Dec. 31, 2012
    Field Expansion Fee [Member]
    Dec. 31, 2012
    Phase I Clinical Trials [Member]
    Dec. 31, 2012
    Phase Iii Clinical Trials [Member]
    Dec. 31, 2012
    Nda Submission In Us [Member]
    Dec. 31, 2012
    European Medicines Agency Approval [Member]
    Dec. 31, 2012
    Regulatory Approval In Asian Country [Member]
    Dec. 31, 2012
    December 31, 2014 [Member]
    Dec. 31, 2012
    December 31, 2015 [Member]
    Dec. 31, 2012
    Office Space In Ann Arbor [Member]
    Dec. 31, 2012
    Office Space In Rockville [Member]
    Dec. 31, 2012
    Intrexon [Member]
    Dec. 31, 2011
    Intrexon [Member]
    Dec. 31, 2012
    Intrexon [Member]
    Jan. 31, 2012
    Intrexon [Member]
    Dec. 31, 2012
    Prev Abr Llc [Member]
    Sep. 30, 2005
    Research and Development Arrangement [Member]
    Feb. 29, 2012
    Dr.Kuo [Member]
    Feb. 29, 2012
    Jeffrey Riley [Member]
    Feb. 29, 2012
    C. Evan Ballantyne [Member]
    Dec. 31, 2012
    Ann Arbor, Michigan [Member]
    Research and development $ 12,287,000 $ 3,340,000                                     $ 7,800,000     $ 460,000        
    Line of Credit Facility, Periodic Payment     197,000                                                  
    Line of Credit Facility, Periodic Payment, Interest     5,000                                                  
    Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period                                                 (324,999)      
    Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value                                                   1,700,000 1,000,000  
    Consulting Fees                                                 17,000      
    Officers' Compensation                                                   348,000 298,000  
    Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross                                                   750,000 425,000  
    Operating Leases, Rent Expense 123,000 64,000                                                    
    Lease Expiration Date May 31, 2013                                                      
    Operating Leases, Future Minimum Payments, Due in Two Years                                 33,000                      
    Operating Lease Leasing Term                                 extend the term of the lease to December 31, 2014 one year operating lease that may be renewed for two additional terms of one year                    
    Operating Leases, Future Minimum Payments Due, Next Twelve Months                             50,000 25,000   35,000                    
    Milestone Payment                   50,000 100,000 250,000 100,000 100,000                            
    Research Agreement Fixed Fee       303,287 316,438 328,758                                            
    Cash Payment For License Agreement                                             100,000          
    Additional Cash Payment For License Agreement                                             135,000          
    Unregistered Shares Issued To License Agreement                                             625,000          
    Additional Consideration Payable                                             50% in cash and 50% in our stock          
    Issuance of common stock for acquisition of program assets (in shares)                                     3,552,210       625,000          
    Equity Issuance, Per Share Amount                                     $ 0.001                  
    Partial Consideration For Execution                                       Intrexon a number of shares of our common stock equal to 9.995% of the number of shares of our common stock issued                
    Other Commitment, Due In Second Year 60,000                                                     33,000
    Registration Payment Arrangement, Settlement Alternatives             The Company also agreed upon the filing of an Investigational New Drug application with the U.S. Food and Drug Administration for a Synthetic Product, or alternatively the filing of the first equivalent regulatory filing with a foreign regulatory agency (both as applicable, the "IND Milestone Event"), to pay Intrexon either (i) two million dollars ($2M) in cash, or (ii) that number of shares of Common Stock (the "IND Milestone Shares") having a fair market value equaling two million dollars ($2M) where such fair market value is determined using published market data of the share price for Common Stock at the close of market on the business day immediately preceding the date of public announcement of attainment of the IND Milestone Event. Upon the first to occur of either first commercial sale of a Synthetic Product in a country or the granting of the regulatory approval of that Synthetic Product (both as applicable, the "Approval Milestone Event"), the Company agreed to pay to Intrexon either (i) three million dollars ($3M) in cash, or (ii) that number of shares of Common Stock (the "Approval Milestone Shares") having a fair market value equaling three million dollars ($3M) where such fair market value is determined using published market data of the share price for Common Stock at the close of market on the business day immediately preceding the date of public announcement of attainment of the Approval Milestone Event. The Field Expansion Fee must be paid completely in either Common Stock or cash, and will comprise either (i) two million dollars ($2M) in cash for each target in excess of three (3) total that the Company elects, or (ii) that number of shares of Common Stock (the "Field Expansion Fee Shares") having a fair market value equaling two million dollars ($2M) for each such target that the Company elects in excess of three where such fair market value is determined using published market data establishing the volume-weighted average price for a share of Common Stock over the thirty (30) day period immediately preceding the date of the Field Expansion Fee Closing.                                      
    Registration Payment Arrangement, Term In connection with the transactions contemplated by the Stock Purchase Agreement, and pursuant to the Registration Rights Agreement executed and delivered by the Company to Intrexon, the Company agreed to file a "resale" registration statement registering the resale of the First Tranche Shares within 120 days of the closing date of such issuance.                                                      
    Prepaid Expense and Other Assets, Current $ 2,509,000 $ 16,000                                       $ 2,500,000            
    XML 79 R41.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Stock-Based Compensation (Details 4) (USD $)
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Exercise price $ 2.20 $ 1.14
    Expected dividends 0.00% 0.00%
    Expected volatility 110.00% 174.00%
    Risk free interest rate 0.26% 0.71%
    Expected life of warrant 2 years 5 years
    XML 80 R5.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Consolidated Statements of Changes in Stockholders' Equity (USD $)
    In Thousands, except Share data
    Common Stock [Member]
    Additional Paid-In Capital [Member]
    Retained Earnings [Member]
    Total
    Balance at Dec. 31, 2010 $ 23 $ 47,280 $ (43,724) $ 3,579
    Balance (in shares) at Dec. 31, 2010 23,338,707      
    Stock-based compensation 0 973 0 973
    Issuance of common stock for employee compensation 0 94 0 94
    Issuance of common stock for employee compensation (in shares) 73,585      
    Issuance of common stock for exclusive channel collaboration agreement 3 1,684 0 1,687
    Issuance of common stock for exclusive channel collaboration agreement (in shares) 3,123,558      
    Issuance of common stock for consulting fees 0 165 0 165
    Issuance of common stock for consulting fees (in shares) 171,796      
    Issuance of common stock for stock options and warrants exercised 0 15 0 15
    Issuance of common stock for stock options and warrants exercised (in shares) 38,948      
    Issuance of common stock, net of issuance costs 5 6,956 0 6,961
    Issuance of common stock, net of issuance costs (in shares) 4,545,926      
    Warrant liability reclassified to stockholders' equity 0 1,734 0 1,734
    Net loss 0 0 (8,149) (8,149)
    Balance at Dec. 31, 2011 31 58,901 (51,873) 7,059
    Balance (in shares) at Dec. 31, 2011 31,292,520      
    Stock-based compensation 0 1,852 0 1,852
    Issuance of common stock for exclusive channel collaboration agreement 3 7,811 0 7,814
    Issuance of common stock for exclusive channel collaboration agreement (in shares) 3,552,210      
    Issuance of common stock for acquisition of program assets 1 1,168 0 1,169
    Issuance of common stock for acquisition of program assets (in shares) 625,000      
    Issuance of common stock for stock options and warrants exercised 2 2,080 0 2,082
    Issuance of common stock for stock options and warrants exercised (in shares) 2,143,018      
    Issuance of common stock, net of issuance costs 7 10,113 0 10,120
    Issuance of common stock, net of issuance costs (in shares) 6,750,000      
    Net loss 0 0 (17,068) (17,068)
    Balance at Dec. 31, 2012 $ 44 $ 81,925 $ (68,941) $ 13,028
    Balance (in shares) at Dec. 31, 2012 44,362,748      
    XML 81 R10.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Summary of Significant Accounting Policies
    		 12 Months Ended
    Dec. 31, 2012
    Accounting Policies [Abstract]  
    Basis of Presentation and Significant Accounting Policies [Text Block]
    2. Summary of Significant Accounting Policies

     

    Principles of Consolidation

     

    All inter-company transactions and accounts have been eliminated in consolidation.

     

    Emerging from the Development Stage

     

    During the second quarter of 2010, the Company emerged from the development stage.   A development-stage enterprise is one in which planned principle operations have not commenced or if its operations have commenced, there has been no significant revenue. On May 6, 2010, the Company entered into a Sublicense Agreement (the “Meda Agreement”) with Meda AB of Sweden (“Meda”) and received an up-front payment of $2.5 million. The execution of the Meda Agreement combined with revenues from Adeona Clinical Laboratory were an indication of the commencement of principal operations, and therefore development-stage reporting was no longer required.

     

    Use of Estimates

     

    The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the U.S.A. requires management to make estimates and assumptions that affect the reported amounts reported in the consolidated financial statements and accompanying notes. Such estimates and assumptions impact, among others, the following: the amount allocated to goodwill, the estimated useful lives for property and equipment, fair value of warrants and stock options granted for services or compensation, respectively, estimates of the probability and potential magnitude of contingent liabilities, and the valuation allowance for deferred tax assets due to continuing and expected future operating losses.

     

    Making estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set of circumstances that existed at the date of the consolidated financial statements, which management considered in formulating its estimate could change in the near term due to one or more future confirming events. Accordingly, actual results could differ from those estimates.

     

    Accounts Receivable and Allowance for Doubtful Accounts

     

    Accounts receivable were reported at realizable value, net of allowances for doubtful accounts, which were estimated and recorded in the period the related revenue was recorded. The Company estimated and reviewed the collectability of its receivables based on a number of factors, including the period they were outstanding. Historical collection and payer reimbursement experience was an integral part of the estimation process related to allowances for doubtful accounts associated with Adeona Clinical Laboratory. In addition, the Company regularly assessed the state of its billing operations in order to identify issues, which impacted the collectability of these receivables or reserve estimates. Revisions to the allowances for doubtful accounts estimates were recorded as an adjustment to bad debt expense. Receivables deemed uncollectible were charged against the allowance for doubtful accounts.

     

    Revenue Recognition

     

    The Company records revenue when all of the following have occurred: (1) persuasive evidence of an arrangement exists, (2) the service is completed without further obligation, (3) the sales price to the customer is fixed or determinable, and (4) collectability is reasonably assured.  The Company recognizes milestone payments or upfront payments that have no contingencies as revenue when payment is received.  For the year ended December 31, 2012 and 2011, the Company’s only stream of revenue was laboratory revenue.  Laboratory revenues are a component of discontinued operations for the years ended December 31, 2012 and 2011. See Note 3 – Discontinued Operations of Adeona Clinical Laboratory.

     

    License Revenues

     

    The Company’s licensing agreements may contain multiple elements, such as non-refundable up-front fees, payments related to the achievement of particular milestones and royalties. Fees associated with substantive at risk performance-based milestones are recognized as revenue upon completion of the scientific or regulatory event specified in the agreement. When the Company has substantive continuing performance obligations under an arrangement, revenue is recognized over the performance period of the obligations using a time-based proportional performance approach. Under the time-based method, revenue is recognized over the arrangement’s estimated performance period based on the elapsed time compared to the total estimated performance period. Revenue recognized at any point in time is limited to the amount of non-contingent payments received or due. When the Company has no substantive continuing performance obligations under an arrangement, it recognizes revenue as the related fees become due.

     

    Revenues from royalties on third-party sales of licensed technologies are generally recognized in accordance with the contract terms when the royalties can be reliably determined and collectibility is reasonably assured. To date, the Company has not received any royalty revenues.

     

    In 2010, the Company entered into the Meda Agreement for the development and commercialization of Effirma (oral flupirtine) for fibromyalgia.  As consideration for the sublicense, the Company received an up-front payment of $2.5 million upon execution of the Meda Agreement. This payment was recorded as license revenue in 2010. Pursuant to the Company’s license agreement with McLean Hospital, the Company paid 15% of the $2.5 million payment ($375,000), that was netted against the revenues received from Meda AB. The Company is also entitled to additional milestone payments of $5 million upon filing of an NDA with the U.S. FDA for oral flupirtine for fibromyalgia and $10 million upon marketing approval. The Meda Agreement also provides that the Company is entitled to receive net royalties of 7% of net sales of oral flupirtine approved for the treatment of fibromyalgia covered by issued patent claims in the U.S. and Japan. The Meda Agreement provides that Meda AB will assume all future development costs for the commercialization of oral flupirtine for fibromyalgia. Pursuant to the terms of the Company’s agreement with McLean Hospital, the Company is obligated to pay half of all future royalties the Company receives.  Future milestone payments will be recorded as revenue when payment is received as there are no future deliverables, and it is non-refundable.

     

    Laboratory Revenues

     

    The Company primarily recognized revenue for services rendered upon completion of the testing process. Billing for services reimbursed by third-party payers, including Medicare and Medicaid, were recorded as revenues, net of allowances for differences between amounts billed and the estimated receipts from such payers.

     

    The Company maintained a sales allowance to compensate for the difference in its billing practices and insurance company reimbursements. In determining this allowance, the Company looked at several factors, the most significant of which was the average difference between the amount charged and the amount reimbursed by insurance carriers over the prior 12 months, otherwise known as the yearly average adjustment amount. The allowance taken was the averaged yearly average adjustment amount for these prior period multiplied by the period’s actual gross sales to determine the actual sales allowance for each period. See Note 3 - Discontinued Operations of Adeona Clinical Laboratory.

     

    Risks and Uncertainties

     

    The Company's operations could be subject to significant risks and uncertainties including financial, operational and regulatory risks and the potential risk of business failure. The global economic crisis has caused a general tightening in the credit markets, lower levels of liquidity, increases in the rates of default and bankruptcy, and extreme volatility in credit, equity and fixed income markets. These conditions may not only limit our access to capital, but also make it difficult for our customers, our vendors and us to accurately forecast and plan future business activities.

     

    Cash and Cash Equivalents

     

    Cash and cash equivalents include cash and highly liquid short-term investments with original maturities of three months or less.

     

    Classification of Marketable Securities as Held to Maturity, Trading, and Available for Sale

     

    The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and reevaluates such determinations at each balance sheet date. Debt securities are classified as held to maturity when the Company has the positive intent and ability to hold the securities to maturity. Debt securities for which the Company does not have the intent or ability to hold to maturity are classified as available for sale. Held to maturity securities are recorded as either short-term or long-term on the balance sheet, based on contractual maturity date and are stated at amortized cost. Marketable securities that are bought and held principally for the purpose of selling them in the near term are classified as trading securities and are reported at fair value, with unrealized gains and losses recognized in earnings. Debt and marketable equity securities not classified as held to maturity or as trading, are classified as available for sale, and are carried at fair market value, with the unrealized gains and losses, net of tax, included in the determination of comprehensive income and reported in shareholders’ equity. At December 31, 2012 and 2011, respectively, the Company had no debt and marketable equity securities.

     

    During the year ended December 31, 2011, the Company held investments in marketable securities that were classified as held to maturity and consisted of corporate bonds and certificates of deposits as follows (in thousands) :

     

        December 31, 2011  
    Purchase of short-term investments   $ (4,370 )
    Amortization of premium on investments     57  
    Proceeds from short-term investments     4,293  
    Loss on sale of short-term investments     20  
    Fair value   $ -  

     

    Property and Equipment

     

    Property and equipment is recorded at cost and depreciated or amortized using the straight-line method over the estimated useful life of the asset or the underlying lease term for leasehold improvements, whichever is shorter. The estimated useful life by asset description is noted in the following table.

     

    Asset Description   Estimated Useful Life
    Office equipment and furniture   3-5  years
    Laboratory equipment   7-10 years
    Manufacturing equipment   10 years
    Leasehold improvements and fixtures   Lesser of estimated useful or life of lease

     

    Depreciation expense was approximately $63,000 and $144,000 for the years ended December 31, 2012 and 2011, respectively. When assets are disposed of, the cost and accumulated depreciation are removed from the accounts. Repairs and maintenance are charged to expense as incurred.

     

    During 2012, the Company reviewed property and equipment for impairment and determined that certain items were impaired due to obsolescence. As a result of this review, the Company recorded an impairment loss of approximately $47,000. For the year ended December 31, 2011, there were no significant events or changes in circumstances identified by the Company that would indicate that the carrying value of an asset was not recoverable.

     

    Long-Lived Assets

     

    The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such an event or change in circumstances occurs and potential impairment is indicated because the carrying values exceed the estimated future undiscounted cash flows of the asset, the Company will measure the impairment loss as the amount by which the carrying value of the asset exceeds its fair value.

     

    Goodwill

     

    Goodwill was not amortized, and was tested for impairment at the reporting unit level annually and in interim periods if certain events occur indicating that the carrying value of goodwill was impaired. A reporting unit was an operating segment for which discrete financial information was available and was regularly reviewed by management. The Company had one reporting unit, Adeona Clinical Laboratory, to which goodwill was assigned.

     

    ASC No. 350, “Intangibles – Goodwill and Others,” requires a two-step approach to test goodwill for impairment for each reporting unit. The first step tests for impairment by applying fair value-based tests to a reporting unit. The second step, if deemed necessary, measures the impairment by applying fair value-based tests to specific assets and liabilities within the reporting unit. Application of the goodwill impairment tests require judgment, including identification of reporting units, assignment of assets and liabilities to each reporting unit, assignment of goodwill to each reporting unit, and determination of the fair value of each reporting unit. The determination of fair value for a reporting unit could be materially affected by changes in these estimates and assumptions.

     

    At December 31, 2011, in connection with the Company classifying Adeona Clinical Laboratory as discontinued operations, previously recorded goodwill was considered impaired. See Note 3 – Discontinued Operations of Adeona Clinical Laboratory.

     

    Derivative Liabilities

     

    Once determined, derivative liabilities are adjusted to reflect fair value at each reporting period end, with any increase or decrease in the fair value being recorded in results of operations as an adjustment to fair value of derivatives. In addition, the fair value of freestanding derivative instruments such as warrants, are also valued using the Black-Scholes option pricing model.

     

    Net Income (Loss) per Share

     

    Net income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding. Diluted income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding including the effect of common share equivalents. All common equivalent shares were anti-dilutive, at December 31, 2012 and December 31, 2011, as such there is no separate computation for diluted loss per share. The number of options and warrants for the purchase of common stock, that were excluded from the computations of net loss per common share for the year ended December 31, 2012 were 4,453,746 and 1,632,501, respectively, and for the year ended December 31, 2011 were 2,979,010 and 3,259,186, respectively.

     

    Research and Development Costs

     

    The Company expenses research and development costs associated with developmental products not yet approved by the FDA to research and development expense as incurred. Research and development costs consist primarily of license fees (including upfront payments), milestone payments, manufacturing costs, salaries, stock-based compensation and related personnel costs, fees paid to consultants and outside service providers for laboratory development, legal expenses resulting from intellectual property prosecution and other expenses relating to the design, development, testing and enhancement of the Company’s product candidates.

     

    Fair Value of Financial Instruments

     

    The fair value accounting standards define fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is determined based upon assumptions that market participants would use in pricing an asset or liability. Fair value measurements are rated on a three-tier hierarchy as follows:

     

      · Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets;

     

      · Level 2 inputs: Inputs, other than quoted prices included in Level 1 that are observable either directly or indirectly; and

     

      · Level 3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions.

     

    In many cases, a valuation technique used to measure fair value includes inputs from multiple levels of the fair value hierarchy described above. The lowest level of significant input determines the placement of the entire fair value measurement in the hierarchy.

     

    The carrying amounts of the Company’s short-term financial instruments, including cash and cash equivalents, accounts receivable, other current assets, accounts payable and accrued liabilities, approximate fair value due to the relatively short period to maturity for these instruments.

     

    Cash and cash equivalents include money market accounts and mutual funds of $8.6 million and $5.0 million as of December 31, 2012 and December 31, 2011, respectively, that are measured using Level 1 inputs. 

     

    Stock-Based Payment Arrangements

     

    Generally, all forms of stock-based payments, including stock option grants, warrants, restricted stock grants and stock appreciation rights are measured at their fair value on the awards’ grant date typically using a Black-Scholes pricing model, based on the estimated number of awards that are ultimately expected to vest. Stock-based compensation awards issued to non-employees for services rendered are recorded at either the fair value of the services rendered or the fair value of the stock-based payment, whichever is more readily determinable and are re-measured over the corresponding vesting period. The expense resulting from stock-based payments is recorded in research and development expense or general and administrative expense in the consolidated statement of operations, depending on the nature of the services provided.

     

    Income Taxes

     

    The Company accounts for income taxes in accordance with accounting guidance now codified as FASB ASC Topic 740, “Income Taxes,” which requires that the Company recognize deferred tax liabilities and assets based on the differences between the financial statement carrying amounts and the tax bases of assets and liabilities, using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit (expense) results from the change in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all deferred tax assets will not be realized.

     

    In addition, accounting guidance now codified as FASB ASC Topic 740-20, “Income Taxes – Intraperiod Tax Allocation” requires management to assess the need to accrue or disclose uncertain tax positions for proposed potential adjustments from various federal and state authorities who regularly audit the Company in the normal course of business. In making these assessments, management must often analyze complex tax laws of multiple jurisdictions. The accounting guidance prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company records the related interest expense and penalties, if any, as tax expense in the tax provision. At December 31, 2012 and 2011, respectively, the Company did not record any liabilities for uncertain tax positions.

     

    Recent Accounting Pronouncements

     

    There were no accounting standards or interpretations issued or recently adopted that are expected to have a material impact on the Company’s financial position, operations, or cash flows.
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    Summary of Significant Accounting Policies (Details) (USD $)
    In Thousands, unless otherwise specified
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Purchase of short-term investments $ 0 $ (4,370)
    Amortization of premium on investments 0 57
    Proceeds from short-term investments 0 4,293
    Loss on sale of short-term investments 0 20
    Fair value   $ 0
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    Stock-Based Compensation (Details 1) (USD $)
    		 12 Months Ended
    Dec. 31, 2012
    Dec. 31, 2011
    Dec. 31, 2010
    Number of Options Outstanding,Begining Balance 2,979,010 2,539,091  
    Number of Options, Granted 2,075,000 557,002  
    Number of Options, Exercised (374,851) (23,333)  
    Number of Options, Forfeited (225,413) (93,750)  
    Number of Options Outstanding,Ending Balance 4,453,746 2,979,010 2,539,091
    Number of Options, Balance exercisable 2,891,877    
    Weighted Average Exercise Price per Share, Balance $ 1.34 $ 1.32  
    Weighted Average Exercise Price per Share, Granted $ 2.21 $ 1.26  
    Weighted Average Exercise Price per Share, Excercised $ 0.34 $ 0.57  
    Weighted Average Exercise Price per Share, Forfeited or expired $ 2.37 $ 0.59  
    Weighted Average Exercise Price per Share, Balance outstanding $ 1.78 $ 1.34 $ 1.32
    Options Exercisable, Weighted Average Exercise Price $ 1.60    
    Options Outstanding, Weighted Average Remaining Contractual Life 6 years 5 months 5 days 6 years 0 months 4 days 6 years 11 months 19 days
    Options Exercisable, Weighted Average Remaining Contractual Life 5 years 8 months 16 days    
    Aggregate Intrinsic Value Outstanding,Begining Balance $ 0 $ 1,028,000  
    Aggregate Intrinsic Value Outstanding,Ending Balance 1,308,000 0 1,028,000
    Aggregate Intrinsic Value Excisable 1,160,000    
    Grant date fair value of options granted $ 4,467,984 $ 609,000  
    Weighted average grant date fair value $ 2.15 $ 1.09  
    XML 86 R20.htm IDEA: XBRL DOCUMENT v2.4.0.6
    Summary of Significant Accounting Policies (Tables)
    		 12 Months Ended
    Dec. 31, 2012
    Accounting Policies [Abstract]  
    Held-to-maturity Securities [Table Text Block]

    During the year ended December 31, 2011, the Company held investments in marketable securities that were classified as held to maturity and consisted of corporate bonds and certificates of deposits as follows (in thousands) :

     

     

     

    December 31, 2011

     

    Purchase of short-term investments

     

    $

    (4,370

    )

    Amortization of premium on investments

     

     

    57

     

    Proceeds from short-term investments

     

     

    4,293

     

    Loss on sale of short-term investments

     

     

    20

     

    Fair value

     

    $

    -

     
    Estimated Useful Life Of Assets [Table Text Block]

    Property and equipment is recorded at cost and depreciated or amortized using the straight-line method over the estimated useful life of the asset or the underlying lease term for leasehold improvements, whichever is shorter. The estimated useful life by asset description is noted in the following table.

     

    Asset Description

     

    Estimated Useful Life

    Office equipment and furniture

     

    3-5  years

    Laboratory equipment

     

    7-10 years

    Manufacturing equipment

     

    10 years

    Leasehold improvements and fixtures

     

    Lesser of estimated useful or life of lease

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