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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
| þ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2011
| ¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 0-21990
OXiGENE, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 13-3679168 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
701 Gateway Boulevard, Suite 210 South San Francisco, CA | 94080 (Zip Code) | |
| (Address of principal executive offices) |
Registrant’s telephone number, including area code: (650) 635-7000
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class | Name of Each Exchange on Which Registered | |
Common stock, par value $0.01 per share Common stock purchase rights | The NASDAQ Stock Market, LLC |
Securities registered pursuant to Section 12(g) of the Act:
None
(Title of class)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ¨ No þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ¨ No þ
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes þ No ¨
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K, or any amendment to this Form 10-K. þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
| Large accelerated filer ¨ | Accelerated filer ¨ | Non-accelerated filer ¨ | Smaller reporting company þ | |||
| (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 þ
The aggregate market value of the registrant’s voting and non-voting common stock held by non-affiliates of the registrant (without admitting that any person whose shares are not included in such calculation is an affiliate) computed by reference to the price at which the common stock was last sold, as of June 30, 2011 was $34,155,000.
As of March 22, 2012, the aggregate number of outstanding shares of common stock of the registrant was 16,175,092.
DOCUMENTS INCORPORATED BY REFERENCE
Certain portions of the registrant’s definitive Proxy Statement for the 2012 Annual Meeting of Stockholders are incorporated by reference into Items 10, 11, 12, 13 and 14 of Part III of this Annual Report on Form 10-K.
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SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS
UNDER THE SECURITIES LITIGATION REFORM ACT OF 1995
Except for historical information contained herein, this Annual Report on Form 10-K (“Annual Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks and uncertainties that may cause the Company’s actual results or outcomes to be materially different from those anticipated and discussed herein. Important factors that the Company believes may cause such differences are discussed in the “Risk Factors” section of this Annual Report and in the cautionary statements accompanying the forward-looking statements in this Annual Report. In assessing forward-looking statements contained herein, readers are urged to read carefully all Risk Factors and cautionary statements contained in this Annual Report. Further, the Company operates in an industry sector where securities values may be volatile and may be influenced by regulatory and other factors beyond the Company’s control.
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| ITEM | 1. BUSINESS |
Our Company
Our Business
We are a clinical-stage, biopharmaceutical company developing novel therapeutics primarily to treat cancer. Our primary focus is the development of product candidates referred to as vascular disrupting agents, or VDAs, that selectively disable and destroy abnormal blood vessels that provide solid tumors a means of growth and survival, and also are associated with visual impairment in a number of ophthalmological diseases and conditions.
We intend to primarily target the development of our product candidates for the treatment of rare cancers that will be eligible for orphan drug status from the Food and Drug Administration, or FDA. Our lead candidate, ZYBRESTAT, has been awarded orphan drug status by the FDA and the European Commission in the European Union for the treatment of advanced anaplastic thyroid cancer, or ATC, and for the treatment of medullary, Stage IV papillary and Stage IV follicular thyroid cancers. The FDA has also granted Fast Track status to ZYBRESTAT for the treatment of regionally advanced and/or metastatic ATC, as well as in ovarian cancer.
By focusing on developing ZYBRESTAT in ATC, and potentially pursuing other rare or orphan indications, we believe we will be able to take advantage of significant benefits associated with orphan drug status, such as:
| Ÿ | Study design assistance from the appropriate FDA center, |
| Ÿ | Exemption from application-filing fees, |
| Ÿ | Possible grant funding for Phase 1 and 2 clinical trials, |
| Ÿ | Tax credits for some clinical research expenses, and |
| Ÿ | Seven years of marketing exclusivity after the approval of the drug. |
The Orphan Drug Act was passed in January 1983 to stimulate the research, development, and approval of products that treat rare diseases. An orphan drug is defined as a product that treats a rare disease affecting fewer than 200,000 patients in the United States. Drugs are granted orphan status for a specific indication.
To date, more than 400 subjects have been treated with ZYBRESTAT in human clinical trials, and the drug candidate has generally been observed to be well-tolerated.
ZYBRESTAT for Oncology
ZYBRESTAT is a reversible tubulin binding agent that works by disrupting the network of blood vessels, or vasculature, within solid tumors, also referred to as vascular disruption. Vascular disruption leads to tumor hypoxia, which refers to the process of starving the tumor of vitally necessary oxygen supply and subsequent tumor cell death. More specifically, ZYBRESTAT selectively targets the existing abnormal and largely immature vasculature found specifically in most solid tumors and causes endothelial cells that make up the walls of the blood vessels in that vasculature to lose their normally flat shape and to become round, thus blocking the flow of blood to the tumor. The downstream tumor environment is then deprived of oxygen and nutrients, and the resulting restriction in blood supply kills the cells in the central portion of the tumor. Based on ZYBRESTAT’s positive activity observed in animal models, we have conducted multiple clinical trials of ZYBRESTAT in a variety of tumor types.
Our top priority is to pursue the clinical development of ZYBRESTAT in ATC. ATC is a very aggressive, rare but lethal cancer of the thyroid gland. Because of the rapid progression of the disease and the absence of effective therapies, median survival from the time of diagnosis is approximately 3-4 months. We have completed a Phase 2/3 clinical trial of ZYBRESTAT in patients with ATC, and we are currently planning a pivotal Phase 3
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clinical trial of ZYBRESTAT in ATC, which we refer to as the FACT 2 trial. We believe that the FACT 2 trial represents a critical opportunity to demonstrate the value of our key asset, ZYBRESTAT, and has the potential to create significant value for our company and our shareholders. As such, our primary corporate strategy for 2012 is to secure sufficient funding to conduct the trial. We also intend to pursue a special protocol assessment (SPA) for this program with the FDA, with the goal of laying the foundation for initiation of this global registration study. We believe completion of the FACT2 study, assuming continued positive clinical results, will be sufficient to obtain FDA approval and approval in Europe for the treatment of patients with advanced ATC.
Clinical Development of ZYBRESTAT in anaplastic thyroid cancer (ATC)
In earlier Phase 1 studies of ZYBRESTAT in ATC, clinical investigators observed several objective responses in treatment with ZYBRESTAT, including a complete response lasting more than 13 years, in patients with ATC. A subsequent Phase 2 study in 26 ATC patients showed a 23% rate of one year survival in a disease where median expected survival of patients is approximately 3-4 months from the time of diagnosis and fewer than 10% of patients are typically alive at one year.
We subsequently conducted the FACT (fosbretabulin in anaplastic cancer of the thyroid) trial, a randomized Phase 2/3 study in ATC, which enrolled 80 patients between July 2007 and February 2010. A total of 40 clinical sites in 11 countries participated in this clinical study, which was conducted in accordance with good clinical practice guidelines and a Special Protocol Assessment, or SPA, with the FDA. The trial was originally designed to evaluate ZYBRESTAT in 180 patients as a potential treatment for ATC.
The primary endpoint for the FACT trial was overall survival. Eligible patients were randomized to receive either ZYBRESTAT in combination with the chemotherapeutic agents carboplatin and paclitaxel, or to the control arm of the study, in which they received only carboplatin and paclitaxel. Central pathology review by external pathologists not associated with the study was utilized to confirm the histological diagnosis prior to enrollment of patients.
Due to the rarity of the disease and the fact that many of the patients screened for the study did not meet the trial’s inclusion criteria or either died or no longer met the trial’s inclusion criteria, the enrollment period spanned more than twice the planned 18 month period. As a result of both the length of the enrollment period and financial constraints affecting us, in February 2010, we chose to continue to treat and follow all 80 patients who were enrolled in the Phase 2/3 FACT clinical trial in ATC in accordance with the SPA, but to stop further enrollment.
During a meeting on March 16, 2011, the FDA indicated that the data from the FACT trial are suggestive of possible clinical activity that may warrant continued development, and that to seek regulatory approval, we should plan to conduct an additional clinical trial with a survival endpoint. The FDA also confirmed that, as we expected, the SPA that had been agreed upon at the start of the study is no longer in effect.
In June 2011, Julie Sosa, M.D., Associate Professor of Surgery and of Medicine at Yale University and principal investigator in the Phase 2/3 study, presented final data from the trial at the American Society of Clinical Oncology (ASCO) conference in Chicago, Illinois. Dr. Sosa presented data reflecting a median overall survival (OS) time of 5.2 months for patients who received ZYBRESTAT and chemotherapy compared with 4.0 months for patients receiving chemotherapy alone, representing a 28% reduction in the risk of death for patients receiving ZYBRESTAT and chemotherapy. For patients treated with ZYBRESTAT and chemotherapy, the data suggested that the likelihood of being alive at six months was 48% compared with 35% for patients treated with the control arm regimen. At one year, the data suggested that the likelihood of being alive was 26% for patients treated with ZYBRESTAT and chemotherapy compared with 9% for patients treated with chemotherapy alone. As in other studies, ZYBRESTAT appeared to be well tolerated.
We are currently planning to conduct a pivotal Phase 3 clinical trial of ZYBRESTAT in ATC, the FACT 2 trial, subject to obtaining sufficient financial resources in order to do so. A Company-sponsored Phase 3 registrational study of ZYBRESTAT in patients with ATC, as suggested by the FDA, would require significant additional capital. Due to the rarity of ATC, which afflicts only approximately 4,000 people worldwide per year, and the fact that the median length of survival from time of diagnosis for patients with ATC is only
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approximately 3-4 months, our strategy is to recruit patients to a large number of clinical trial sites to participate in the trial. We are hopeful that we can finance a large portion of the costs of this trial from private and/or public equity offerings; however, clinical trials are extremely costly and time-consuming, particularly in orphan indications such as ATC. Any significant progress related to this clinical trial will be dependent on obtaining sufficient financial resources in order to do so.
In December 2011, we established a partnership agreement to provide access to ZYBRESTAT for the treatment of patients in a specified territory with ATC on a compassionate use basis. Our newly formed named patient program, to be managed by Azanta Danmark A/S, or Azanta, provides a regulatory mechanism to allow healthcare professionals in the territory to prescribe ZYBRESTAT to individual ATC patients while it is still in development. Under the terms of the agreement, we will provide ZYBRESTAT to Azanta, and Azanta will serve as our exclusive distributor for ZYBRESTAT in the specified territory for this purpose. Azanta will provide ZYBRESTAT to physicians solely to treat ATC on a compassionate use basis in the territory covered by the agreement until such time as ZYBRESTAT may obtain marketing approval in that territory. The territory includes the European Union, including the Nordic countries and Switzerland, and Canada, and the agreement may also be expanded to include other countries on a country-by-country basis. We and Azanta will cooperate on regulatory activities relating to ZYBRESTAT for the treatment of ATC within the territory. There will be no transfer of ownership of intellectual property rights for ZYBRESTAT to Azanta under the terms of the agreement.
FALCON (fosbretabulin in advanced lung oncology) trial — randomized, controlled Phase 2 study with ZYBRESTAT in non-small cell lung cancer
We evaluated ZYBRESTAT in a randomized, controlled Phase 2 clinical trial, which we refer to as the FALCON trial, as a potential first-line treatment for stage IIIB/IV non-small cell lung cancer, or NSCLC. In the FALCON trial, patients were randomized either to the treatment arm of the study, in which they received ZYBRESTAT in combination with the chemotherapeutic agents, carboplatin and paclitaxel, and bevacizumab, a drug that interferes with blood vessel growth, or angiogenesis, or to the control arm of the study, in which they received a standard combination regimen of carboplatin, paclitaxel and bevacizumab. The objective of the study was to determine the safety, tolerability, and efficacy of ZYBRESTAT at a dose of 60 mg/m2 in combination with carboplatin, paclitaxel and bevacizumab in Stage IIIB or IV non-squamous NSCLC. Primary endpoints of this study were safety of the combination therapy and progression-free survival; secondary endpoints were overall survival and objective response rate.
Edward Garon, M.D., Assistant Professor of Medicine at the University of California, Los Angeles and primary investigator in the study, presented the progression-free survival data from this study at the ASCO conference in Chicago, Illinois in June 2011. Dr. Garon’s updated analysis, conducted approximately 11 months after the enrollment of the last patient in June 2010, showed that the combination regimen of ZYBRESTAT plus bevacizumab, carboplatin and paclitaxel (ZYBRESTAT arm) appeared to be well-tolerated with no significant cumulative toxicities when compared with the control arm of the study. Dr. Garon’s presentation also included data on the achieved rate of objective response. In terms of Partial Response as Best Overall Tumor Response (Intent to Treat) patients on the active treatment arm including ZYBRESTAT achieved a 56% rate of objective response according to RECIST criteria, as compared to 36% on the control arm. Further analysis also suggested that the addition of ZYBRESTAT may benefit patients with a poorer performance status. Poor performance status in this context refers to patients who present with higher tumor burden or larger tumors, who have additional medical complications, who suffer from additional illnesses such as emphysema or diabetes, or who may be taking other medications.
Since the initial presentation of the progression-free survival data at ASCO 2011, the overall survival follow-up has continued with each patient having been followed for survival for at least one year following the initiation of study therapy. The final results from this analysis were available in November 2011, and the analysis of the data showed that the combination regimen of ZYBRESTAT plus bevacizumab, carboplatin and paclitaxel (ZYBRESTAT arm) was observed to be well-tolerated with no significant cumulative toxicities or overlapping toxicities with bevacizumab when compared with the control arm of the study (standard chemotherapy plus bevacizumab). However, for the overall patient population, no survival benefit was observed for patients
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receiving ZYBRESTAT. Similar to the initial findings regarding progression-free survival, an analysis of patients with more advanced disease as indicated by a tumor burden greater than 10 cm or poor performance status suggested meaningful improvements in overall survival for patients receiving ZYBRESTAT in addition to bevacizumab and chemotherapy.
While we believe that these data could be used to design a specific clinical program with ZYBRESTAT and more generally, provide clinical validation supporting further evaluation of ZYBRESTAT in patients with poor-prognosis NSCLC in combination with standard chemotherapy and anti-VEGF therapy, there is no precedent and no established regulatory pathway for such an approach. Therefore, we are not currently actively pursuing poor-prognosis NSCLC as a target indication.
ZYBRESTAT in ovarian cancer
At the 2009 ASCO Annual Meeting, we reported positive final data from an investigator-sponsored Phase 2 study of ZYBRESTAT and carboplatin plus paclitaxel chemotherapy in patients with platinum-resistant ovarian cancer. Ovarian cancer is an orphan indication, and OXiGENE has received orphan designation for ZYBRESTAT in this indication.
Based on the results of this Phase 2, single-arm, two-stage study, in February 2011, we entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute’s (NCI) Cancer Therapy Evaluation Program (CTEP) to collaborate on the conduct of a randomized Phase 2 trial of ZYBRESTAT in combination with bevacizumab in up to 110 patients with relapsed, platinum-sensitive ovarian cancer. Under the terms of the agreement, we are providing ZYBRESTAT to NCI for an NCI-sponsored study being conducted by the Gynecologic Oncology Group (GOG), an organization dedicated to clinical research in the field of gynecologic cancer. The aim of the trial will be to determine if the combination of ZYBRESTAT and bevacizumab will enhance anti-tumor effects and further delay tumor progression when compared to bevacizumab alone. Investigators initiated enrollment in this Phase 2 study in the first half of 2011, and this study is actively recruiting patients. The primary endpoint of the study will be progression-free survival, with results expected to become available in early 2013.
The June 2011 ASCO meeting in Chicago, Illinois included an announcement that the addition of Avastin (bevacizumab) to a chemotherapy regimen reduces the risk of progression in patients with platinum-sensitive ovarian cancer. This is of particular interest to OXiGENE in view of the NCI / CTEP Phase 2 study of ZYBRESTAT in combination with bevacizumab for platinum-sensitive ovarian cancer patients, and we are encouraged to see additional data from other studies supporting use of bevacizumab in platinum-sensitive ovarian cancer patients.
Possible areas for future development
ATC and ovarian cancer, and potentially other orphan indications, represent areas for further development and significant unmet medical needs, and thus significant potential commercial market opportunities.
Further development of our ongoing clinical trials will depend on continuing analysis and results of ongoing clinical studies, as well as available financial resources and/or potential partnering activities.
OXi4503, a unique, second generation VDA for oncology indications
We are currently pursuing development of OXi4503, a second-generation, dual-mechanism VDA, as a treatment for certain solid tumor types and for the treatment of myeloid leukemias, which also represent orphan indications. We believe that OXi4503 is differentiated from other VDAs by its dual-action activity: in addition to having potent vascular disrupting effects, OXi4503 is unique in that certain enzymes in the human body can help convert it to a form of chemical that has direct tumor cell killing effects. We believe this unique property may result in enhanced anti-tumor activity in certain tumor types as compared with other VDA drug candidates. Based on data from preclinical studies, we believe that OXi4503 may have enhanced activity in tumor types with relatively high levels of the enzymes that facilitate the conversion of OXi4503 to the form of chemical that kills tumor cells. These tumor types include hepatocellular carcinoma, melanoma, and leukemias of the myeloid lineage. In preclinical studies, OXi4503 has shown potent anti-tumor activity against solid tumors and acute myeloid leukemia models, both as a single agent and in combination with other cancer treatment modalities.
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We have completed a Phase 1 clinical trial of OXi4503 in patients with advanced solid tumors sponsored by Cancer Research United Kingdom. In collaboration with us, Professor Gordon Rustin and colleagues from the Mount Vernon Cancer Research Centre, UK and other institutions in the United Kingdom, reported positive final data from this study at the 2010 ASCO Annual Meeting. In this study, 45 patients with advanced solid tumors who had declined or were unresponsive to standard treatment were treated with escalating doses of OXi4503. Partial responses were observed in two patients with epithelial ovarian cancer and stable disease was observed in 9 patients. OXi4503 was also observed to be well-tolerated in this study. To date, OXi4503 has been observed to have a manageable side-effect profile similar to that of other agents in the VDA class, potential single-agent clinical activity, and effects on tumor blood flow and tumor metabolic activity, as determined with several imaging modalities. We also evaluated escalating doses of OXi4503 in an OXiGENE-sponsored Phase 1b trial, initiated in the first quarter of 2009 in patients with solid tumors with hepatic involvement. This study confirmed the recommended dose established in the first Phase 1 study. Currently, we are exploring possible clinical studies but we have no firm plans to continue the evaluation of OXi4503 in patients with solid tumors.
Based on the results of preclinical studies published in the journal Blood in September 2010 that show OXi4503 has potent activity against acute myelogenous leukemia (AML) in animal models, we entered into a clinical trial agreement pursuant to which investigators at the University of Florida initiated an investigator sponsored Phase 1 study of OXi4503 in patients with AML or myelodysplastic syndrome (MDS) in May 2011. This open-label, dose-escalating study for the treatment of up to 36 patients is being conducted in patients with relapsed or refractory AML and MDS and will evaluate the safety profile, maximum tolerated dose and biologic activity of OXi4503 in these patients. We expect that initial indications of biologic activity from this study may be available in the fourth quarter of 2012.
The general direction of future development of OXi4503 for hematologic indications will depend on the outcome of the analysis of the study in AML, as well as available financial resources and potential partnering activities.
ZYBRESTAT for Ophthalmology
In addition to developing ZYBRESTAT as an intravenously administered therapy for oncology indications, we have previously undertaken an ophthalmology research and development program with ZYBRESTAT with the ultimate goal of developing a topical formulation of ZYBRESTAT for ophthalmological diseases and conditions that are characterized by abnormal blood vessel growth within the eye that result in loss of vision. Due to financial constraints, we are not actively pursuing development in this area at this time.
In December 2010, we completed a randomized, double-masked, placebo-controlled Phase 2 proof-of-mechanism trial, which we refer to as the FAVOR trial, with a single dose of intravenously-administered ZYBRESTAT in patients with polypoidal choroidal vasculopathy (PCV), a form of choroidal neovascularization, which is a condition where new blood vessels form in the choroid, a part of the eye, and which can lead to vision loss and, ultimately, blindness. Current therapies, including approved drugs that interfere with blood vessel growth, known as anti-angiogenics, appear to provide limited benefit. We believe that the architecture of the abnormal vasculature in certain eye tissues, namely the retina and choroid, which contribute to PCV patients’ loss of vision, may be particularly susceptible to treatment with a VDA such as ZYBRESTAT.
Data from the FAVOR trial, in which ZYBRESTAT at different doses was compared to placebo in patients with PCV, followed by imaging of the retina on days 2, 8, 15, and 28, were presented at the 6th Asia-Pacific VitreoRetina Society (APVRS) Congress in Hyderabad, India on December 2, 2011.
We believe that a safe, effective and convenient topically-administered anti-vascular therapeutic would have advantages over currently approved anti-vascular, ophthalmological therapeutics, many of which must be injected directly into patients’ eyes, in some cases on a chronic monthly basis.
For this purpose we have undertaken preclinical testing of a potential “minitab” topical formulation of ZYBRESTAT which has demonstrated attractive pharmacokinetic and safety properties and efficacy in destroying abnormal vasculature in a rat choroidal melanoma model following administration in the eye. We
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believe that a topical formulation would enhance our partnering opportunities to further develop ZYBRESTAT in diseases of the eye.
We have also evaluated the requirements for additional preclinical toxicology and efficacy studies with ZYBRESTAT for topical ophthalmological formulations to better position the program for partnering. Further development of this program will depend on the outcome of our evaluation of these requirements and available financial resources.
Company Background
We are a Delaware corporation, incorporated in 1988 in the state of New York and reincorporated in 1992 in the state of Delaware, with our principal corporate office in the United States at 701 Gateway Boulevard, Suite 210, South San Francisco, California 94080 (telephone: (650) 635-7000, fax: (650) 635-7001). We also have an office at 300 Bear Hill Road, Waltham, Massachusetts 02451. Our Internet address is www.oxigene.com. Our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and all amendments to those reports, are available to you free of charge through the “Investors” section of our web site as soon as reasonably practicable after such materials have been electronically filed with, or furnished to, the Securities and Exchange Commission. Information contained on our web site does not form a part of this Form 10-K.
VASCULAR DISRUPTING AGENTS: ANTI-VASCULAR THERAPEUTICS THAT ADDRESS A LARGE POTENTIAL MARKET OPPORTUNITY
According to Cancer Research UK, a cancer organization in the United Kingdom, nearly 90% of all cancers, more than 200 types, are solid tumors, which are dependent upon a continually developing vascular supply for their growth and survival. Similarly, in the ophthalmology field, abnormal neovascularization characterizes a variety of ophthalmological diseases and conditions, including corneal neovascularization, central retinal vein occlusion, proliferative diabetic retinopathy, retinopathy of prematurity, sickle cell retinopathy, myopic macular degeneration (MMD), age-related macular degeneration (AMD), and neovascular glaucoma.
Since 2004, multiple drugs that interfere with blood vessel growth or anti-angiogenics (see table below), have been approved for a variety of cancer and ophthalmology indications, and development of approved anti-angiogenic drugs for new indications continues. Physician adoption of these first-generation anti-vascular drugs has been rapid and continues to accelerate.
We believe that our VDA drug candidates are second-generation anti-vascular drugs that differ from and are complementary and non-competitive with anti-angiogenic agents. Similar to anti-angiogenic agents, our VDA drug candidates are anti-vascular drugs that exert therapeutic effects by depriving tumors and in the case of eye disease, ocular lesions of blood supply. We also believe that our VDA therapeutics may be better tolerated than anti-angiogenic drugs and may potentially have utility in later-stage tumors that have become unresponsive to anti-angiogenic therapies.
In September 2006, we announced the publication of a research article in the journal Science that provided strong scientific evidence for combining VDAs with anti-angiogenic agents such as bevacizumab, a widely-used anti-angiogenic drug that acts by inhibiting VEGF, a pro-angiogenic growth factor. In this article, Professor Kerbel and Dr. Shaked from Sunnybrook Cancer Centre in Canada demonstrated that the combination of ZYBRESTAT and an anti-angiogenic agent (an anti-VEGF-receptor antibody) had synergistic effects on tumors.
In December 2007, we completed a Phase 1b clinical trial to evaluate ZYBRESTAT in combination with bevacizumab (an approved and widely-used anti-VEGF monoclonal antibody) in patients with advanced solid tumors. This was the first human clinical trial to pair a vascular disrupting agent and an anti-angiogenic drug in the treatment of cancer, specifically in patients who had failed previous treatments and were in advanced stages of disease. The trial was an open-label, multi-center trial designed to determine the safety and tolerability of ascending doses of ZYBRESTAT administered intravenously in combination with bevacizumab. Three dose levels of ZYBRESTAT were evaluated in combination with an approved dose of bevacizumab. In May of 2008, we reported final data from the trial showing that the two-drug combination appeared to be well-tolerated with early signs of clinical efficacy (9 of 16 patients with stable disease responses with prolonged stable disease observed in several patients) and additive effects on tumor blood-flow inhibition.
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We believe that these pre-clinical and clinical research results suggest combining VDA and anti-angiogenic therapies may be a compelling strategy to maximize the therapeutic potential of VDAs and anti-angiogenic drugs in the treatment of solid tumors. We believe the potential ability to synergistically combine VDA drugs with anti-angiogenic therapeutics affords it a wide range of future development and commercialization options with our VDA drug candidates, including tumor types and treatment settings where anti-angiogenic drugs are commonly utilized, as well as those where anti-angiogenic agents are either poorly tolerated, ineffective, no longer effective, or not commonly utilized.
As illustrated in the table below, VDA and anti-angiogenic drugs act via different mechanisms to produce complementary biological and anti-vascular effects with mostly non-overlapping side effects. In pre-clinical studies, VDA plus anti-angiogenic drug combinations demonstrate robust and additive anti-tumor effects. Results from initial human clinical studies conducted by us with combinations of ZYBRESTAT and the widely-used anti-angiogenic drug, bevacizumab, provide support and initial clinical validation for combining these agents to significantly increase clinical activity without significantly increasing side-effects.
1ST-Generation Anti-Vascular Drugs | 2ND-Generation Anti-Vascular Drugs | |||
| Anti-Angiogenic Drugs(bevacizumab, ranibizumab, sorafenib, sunitinib, pegaptanib, etc.) | OXiGENE VDA Drug Candidates (ZYBRESTAT, OXi4503) | |||
Biological Effect | Prevent formation and growth of new blood vessels throughout the body | Selectively occlude and collapse pre-existing tumor vessels | ||
Mechanism | Continuously inhibit pro-angiogenic growth factor signaling (e.g., VEGF) Promiscuous for all angiogenesis | Intermittently and reversibly collapses abnormal blood vessels that feed tumors | ||
| Selectively blocks the formation of tumor vessel and other abnormal vessel tissue junctions by disrupting the cell junctional protein VE-cadherin | ||||
| ZYBRESTAT half-life is approximately 4 hours | ||||
| Selective for abnormal vasculature characteristic of tumors and certain eye lesions | ||||
Rapidity of Effect | Weeks | Hours | ||
Side Effects | Vascular and non-vascular side-effects, some of which are chronic in nature, e.g., chronic hypertension, wound-healing impairment, hemorrhage/ hemoptysis, gastrointestinal perforation, proteinuria/nephrotic syndrome, thromboembolic events, etc. | Transient and manageable, typical of a “vascularly active” chronic disease (e.g., transient and manageable hypertension) Mostly non-overlapping with Compare favorably with anti- |
We believe our VDA drug candidates act on tumor blood vessels via two complementary mechanisms, tubulin depolymerization and disengagement of the junctional protein VE-cadherin, which cause shape change of tumor vascular endothelial cells, vessel occlusion and collapse, and the subsequent blockage of blood-flow to the tumor, which deprives it of oxygen and nutrients essential for survival.
In vitrostudies have demonstrated that our VDA drug candidates act in a reversible fashion on a protein called tubulin inside newly-formed and growing endothelial cells, such as the vascular endothelial cells comprising tumor
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vasculature. By binding to the tubulin, ZYBRESTAT is able to collapse the structural framework that maintains the cells’ flat shape. When this occurs, the shape of the cells changes from flat to round, initiating a cascade of events resulting in physical blockage of the blood vessels. The resulting shutdown in blood-flow then deprives tumor cells of the oxygen and nutrients necessary for maintenance and growth and also prevents tumor cells from being able to excrete toxic metabolic waste products. The consequence of the blockage is extensive tumor cell death, as demonstrated in animal studies and suggested in imaging studies of human patients treated with ZYBRESTAT and OXi4503.
Pre-clinical research, published in the November 2005 issue of theJournal of Clinical Investigation, showed that ZYBRESTAT also disrupts the molecular engagement of VE-cadherin, a junctional protein important for endothelial cell survival and function. The authors of the research article conclude that this effect only occurs in endothelial cells which lack contact with smooth muscle cells, a known feature of abnormal vasculature associated with tumors and other disease processes. The disengagement of VE-cadherin leads to endothelial cell detachment, which in turn, can cause permanent physical blockage of vessels.
Pre-clinical and clinical study results indicate that ZYBRESTAT exerts anti-vascular effects rapidly, within hours of administration, and the half-life of the active form of ZYBRESTAT in humans is approximately four hours. Because the half-life of the active form of ZYBRESTAT is relatively short, the effects of ZYBRESTAT on tubulin are reversible, and ZYBRESTAT is typically administered no more frequently than once per week, the side-effects of ZYBRESTAT are typically transient in nature, limited to the period of time following administration when the active form of ZYBRESTAT is in the body in significant concentrations. This contrasts with drugs that interfere with blood vessel growth, known as anti-angiogenic agents, which are typically administered on a chronic basis so as to constantly maintain levels of drug in the body, exert their tumor blood-vessel growth inhibiting effects over days to weeks, and as a result can cause a variety of chronic side-effects that are not limited to the immediate period following administration.
In contrast with anti-angiogenic agents, which can cause a variety of chronic side-effects, side-effects associated with ZYBRESTAT are typically transient and manageable. The most frequent ZYBRESTAT side-effects include infusion-related side effects such as nausea, vomiting, headache and fatigue, and tumor pain, which is consistent with the drug’s mechanism-of-action. Like approved anti-angiogenic drugs, ZYBRESTAT also exhibits cardiovascular effects, which in the majority of patients are mild and transient in nature. Approximately 10-20% of patients treated with ZYBRESTAT experience clinically-significant and transient hypertension that can be readily managed and prevented after initial occurrence with straightforward oral anti-hypertensive therapy. In an analysis undertaken by us, the incidence of serious cardiovascular side-effects such as angina and myocardial ischemia observed across all studies to date (including early studies in which hypertension management and prevention was not employed) was less than 3%, a frequency comparable to that reported with approved anti-angiogenic agents such as bevacizumab, sunitinib and sorafenib.
RESEARCH AND DEVELOPMENT AND COLLABORATIVE ARRANGEMENTS
Our strategy is to develop innovative therapeutics for oncology and to leverage our drug candidates and technology in the field of ophthalmology. Our principal focus is to advance the clinical development of our drug candidates ZYBRESTAT and OXi4503 and to identify new pre-clinical candidates that are complementary to our VDAs. To advance our strategy, we have established relationships with universities, research organizations and other institutions in these fields.
We intend to continue to rely on these relationships, rather than expand our in-house research and development staff. In general, these programs are created, developed and controlled by our internal management. Currently, we have collaborative agreements and arrangements with a number of institutions in the United States and abroad, which we utilize to perform the day-to-day activities associated with drug development. In 2011, collaborations were ongoing with a variety of university and research institutions, including the following:
| Ÿ | Baylor University, Waco, Texas; |
| Ÿ | Beth Israel Deaconess Medical Center, Boston, Massachusetts; |
| Ÿ | University of Oxford, Oxford, United Kingdom; and |
| Ÿ | University College London, London, United Kingdom. |
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We have secured a technology license from Arizona State University (ASU). The ASU license is an exclusive, world-wide, royalty-bearing license for commercial development, use and sale of products or services covered by certain patent rights to particular combretastatins, including among others, OXi4503. Under the ASU license, we have the right to grant sublicenses. ASU is entitled to single-digit royalty and milestone payments under the license agreement. We bear the costs of preparing, filing, prosecuting and maintaining all patent applications under the ASU license. Under the license agreement, we have agreed to diligently proceed with the development, manufacture and sale of products using the licensed technology. ASU has the first responsibility of enforcing patents under the license agreement. Either party may terminate the license agreement upon material default or bankruptcy of the other party. Payments made to ASU to date have amounted to $2,500,000. The agreement is to terminate on December 31, 2014 or within two months of receipt of written notice of termination from us.
Under a sponsored research agreement with Baylor University, we are pursuing discovery and development of additional novel, small-molecule therapeutics for the treatment of cancer, including small-molecule cathepsin-L inhibitors and hypoxia-activated VDAs. Cathepsin-L is an enzyme involved in protein degradation and has been shown to be closely involved in the processes of angiogenesis and metastasis. Small molecule inhibitors may have the potential to slow tumor growth and metastasis in a manner we believe could be complementary with our VDA therapeutics. We also believe that our hypoxia-activated VDAs could serve as line-extension products to ZYBRESTAT and/or OXi4503. We also have a license and research agreement from Baylor University. The Baylor agreement provides an exclusive license to all novel compositions developed under a research program that we fund, which focuses on novel compounds for the treatment of vascular disorders, inflammation, parasitic diseases and infections, fungal diseases and infections and/or cancer. We have the right to grant sublicenses under the Baylor license. The agreement with Baylor requires that we either fund the research program from year to year or pay a minimum annual license fee of up to $40,000. The agreement stipulates that we will pay royalties up to the low-single-digits should sales be generated through use of Baylor’s licensed compounds. We are not required to pay Baylor for use of Baylor’s compounds other than pursuant to this arrangement. We are entitled to file, prosecute and maintain patent applications on products for which we have a license under this agreement. We have made a one-time payment of $50,000 for the licensing fee that was used as a credit against research expenses generated by Baylor and we continue to fund the research program under the Baylor agreement. The term of the license shall end upon the expiration of the licensed patents. The latest United States patent licensed under this agreement is scheduled to expire in June 2026.
We also have an exclusive, world-wide, royalty-bearing license from Bristol-Myers Squibb (BMS) for commercial development, use and sale of products or services covered by certain patent rights to particular combretastatins, including among others, ZYBRESTAT. Under the BMS license, we have the right to grant sublicenses. BMS is entitled to low-single-digit royalty payments under the license agreement. All licensing fees and milestone payments under the license agreement, in the aggregate amount of $1,080,000, have been paid. We bear the costs of preparing, filing, prosecuting and maintaining all patent applications under the BMS license and have a right, but not a duty, of enforcing patents covered by the license. Either party may terminate the license upon material default of the other party. The term of the license shall end upon the expiration of the licensed patents. The latest United States patent licensed under this agreement is scheduled to expire in December 2021.
Government Regulation and Product Approval
Government authorities in the United States, at the federal, state and local level, and other countries extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, marketing and export and import of products such as those we are developing. Our drugs must be approved by FDA through the new drug application, or NDA, process before they may be legally marketed in the United States.
U.S. Drug Development Process
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance
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with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution injunctions, fines, refusal of government contracts, restitution, disgorgement, or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us. The process required by the FDA before a drug may be marketed in the United States generally involves the following:
| Ÿ | completion of pre-clinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices or other applicable regulations; |
| Ÿ | submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials may begin; |
| Ÿ | performance of adequate and well-controlled human clinical trials according to Good Clinical Practices to establish the safety and efficacy of the proposed drug for its intended use; |
| Ÿ | submission to the FDA of an NDA; |
| Ÿ | satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current good manufacturing practice, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; |
| Ÿ | satisfactory completion of FDA inspections of clinical sites and GLP toxicology studies; and |
| Ÿ | FDA review and approval of the NDA. |
The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product candidates will be granted on a timely basis, if at all.
Once a pharmaceutical candidate is identified for development it enters the pre-clinical testing stage. Pre-clinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the pre-clinical tests, together with manufacturing information and analytical data, to the FDA as part of the IND. The sponsor will also include a protocol detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated, if the first phase lends itself to an efficacy evaluation. Pre-clinical testing continues even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Clinical holds also may be imposed by the FDA at any time before or during studies due to safety concerns or non-compliance.
All clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with Good Clinical Practice regulations. These regulations include the requirement that all research subjects provide informed consent. Further, an institutional review board, or IRB, must review and approve the plan for any clinical trial before it commences at any institution. An IRB considers, among other things, whether the risks to individuals participating in the trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the information regarding the trial and the consent form that must be provided to each trial subject or his or her legal representative and must monitor the study until completed.
Each new clinical protocol must be submitted to the IND for FDA review, and to the IRBs for approval. Protocols detail, among other things, the objectives of the study, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety.
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Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:
| Ÿ | Phase 1: The drug is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients. |
| Ÿ | Phase 2: Involves studies in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. |
| Ÿ | Phase 3: Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites. These studies are intended to establish the overall risk-benefit ratio of the product and provide, if appropriate, an adequate basis for product labeling. |
During the development of a new drug, sponsors may, under certain circumstances request a special protocol assessment, or SPA, from the FDA. For example, a sponsor may request an SPA of a protocol for a clinical trial that will form the primary basis of an efficacy claim in an NDA. The request, which must be made prior to commencing the trial, must include the proposed protocol and protocol-specific questions that the sponsor would like the FDA to answer regarding the protocol design, study goals and data analysis for the proposed investigation. After receiving the request, the FDA will consider whether the submission is appropriate for an SPA. If an SPA is appropriate, the FDA will base its assessment on the questions posed by the sponsor. Comments from the FDA review team are supposed to be sent to the sponsor within 45 calendar days of receipt of the request. The sponsor may request a meeting to discuss the comments and any remaining issues and uncertainties regarding the protocol. If the sponsor and the FDA reach agreement regarding the protocol, the agreement will be documented and made part of the administrative record. This agreement may not be changed by the sponsor or the FDA after the trial begins, except (1) with the written agreement of the sponsor and the FDA or (2) if the FDA determines that a substantial scientific issue essential to determining the safety or effectiveness of the drug was identified after the testing began.
Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA. IND Safety Reports must be submitted to the FDA, IRBs and the investigators for (a) any suspected adverse reaction that is both serious and unexpected; (b) any findings from epidemiological studies, pooled analysis of multiple studies, or clinical studies (other than those already reported in (a); (c) any findings from animal or in vitro testing, whether or not conducted by the sponsor, that suggest a significant risk in humans exposed to the drug, such as reports of mutagenicity, teratogenicity, or carcinogenicity or reports of significant organ toxicity at or near the expected human exposure; and (d) any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. Phase 1, Phase 2, and Phase 3 testing may not be completed successfully within any specified period, if at all. The FDA or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.
Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final drug. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.
U.S. Review and Approval Processes
The results of product development, pre-clinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug, proposed labeling, and other
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relevant information are submitted to the FDA as part of an NDA requesting approval to market the product. The submission of an NDA is subject to the payment of user fees; a waiver of such fees may be obtained under certain limited circumstances.
In addition, under the Pediatric Research Equity Act, or PREA, an NDA or supplement to an NDA must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers. Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan designation has been granted.
The FDA reviews all NDAs submitted to ensure that they are sufficiently complete for substantive review before it accepts them for filing. The FDA may request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA may refer the NDA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. The approval process is lengthy and difficult and the FDA may refuse to approve an NDA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data and information. Even if such data and information are submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret the same data. The FDA may issue a complete response letter, which may require additional clinical or other data or impose other conditions that must be met in order to secure final approval of the NDA. The FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product’s identity, strength, quality and purity. Before approving an NDA, the FDA will inspect the facility or facilities where the product is manufactured. The FDA will also inspect selected clinical sites that participated in the clinical studies and may inspect the testing facilities that performed the GLP toxicology studies cited in the NDA.
NDAs receive either standard or priority review. A drug representing a significant improvement in treatment, prevention or diagnosis of disease may receive priority review. In addition, products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials. Priority review and accelerated approval do not change the standards for approval, but may expedite the approval process.
If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. In addition, the FDA may require us to conduct Phase 4 testing, which involves clinical trials designed to further assess a drug’s safety and effectiveness after NDA approval, and may require testing and surveillance programs to monitor the safety of approved products which have been commercialized.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for this type of disease or condition will be recovered from sales in the United States for that drug. Orphan drug designation must be requested before submitting an NDA. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.
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If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same indication, except in very limited circumstances, for seven years. Orphan drug exclusivity, however, also could block the approval of one of our products for seven years if a competitor obtains approval of the same drug as defined by the FDA or if our product candidate is determined to be contained within the competitor’s product for the same indication or disease.
In the European Union and Japan, orphan drug exclusivity regulations provide for 10 years of marketing exclusivity for orphan drugs that are approved for the treatment of rare diseases or conditions.
ZYBRESTAT was awarded orphan drug status by the FDA for the treatment of anaplastic, medullary, Stage IV papillary and Stage IV follicular thyroid cancers, as well as in Ovarian cancer and by the European Commission in the European Union for the treatment of anaplastic thyroid cancer.
Expedited Review and Approval
The FDA has various programs, including Fast Track, priority review, and accelerated approval, which are intended to expedite or simplify the process for reviewing drugs, and/or provide for approval on the basis of surrogate endpoints. Even if a drug qualifies for one or more of these programs, we cannot be sure that the FDA will not later decide that the drug no longer meets the conditions for qualification or that the time period for FDA review or approval will be shortened. Generally, drugs that may be eligible for these programs are those for serious or life-threatening conditions, those with the potential to address unmet medical needs, and those that offer meaningful benefits over existing treatments. Fast Track designation applies to the combination of the product and the specific indication for which it is being studied. Although Fast Track and priority review do not affect the standards for approval, the FDA will attempt to facilitate early and frequent meetings with a sponsor of a Fast Track designated drug and expedite review of the application for a drug designated for priority review. Drugs that receive an accelerated approval may be approved on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect of a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform post-marketing clinical trials.
The FDA has granted Fast Track designation to ZYBRESTAT for the treatment of regionally advanced and/or metastatic ATC.
Foreign Regulation
Before our products can be marketed outside of the United States, they are subject to regulatory approval similar to that required in the United States, although the requirements governing the conduct of clinical trials, including additional clinical trials that may be required, product licensing, pricing and reimbursement vary widely from country to country. No action can be taken to market any product in a country until an appropriate application has been approved by the regulatory authorities in that country. The current approval process varies from country to country, and the time spent in gaining approval varies from that required for FDA approval. In certain countries, the sales price of a product must also be approved. The pricing review period often begins after market approval is granted. Even if a product is approved by a regulatory authority, satisfactory prices may not be approved for such product.
In Europe, marketing authorizations may be submitted at a centralized, a decentralized or national level. The centralized procedure is mandatory for the approval of biotechnology products and provides for the grant of a single marketing authorization that is valid in all European Union members’ states. As of January 1995, a mutual recognition procedure is available at the request of the applicant for all medicinal products that are not subject to the centralized procedure. There can be no assurance that the chosen regulatory strategy will secure regulatory approvals on a timely basis or at all.
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PATENTS AND PROPRIETARY RIGHTS
We actively seek to protect the proprietary technology that we consider important to our business, including chemical species, compositions and forms, their methods of use and processes for their manufacture, as well as modified forms of naturally-expressed receptors, in the United States and other jurisdictions internationally that we consider key pharmaceutical markets. We also rely upon trade secrets and contracts to protect our proprietary information.
As of March 9, 2012, we were the exclusive licensee, sole assignee or co-assignee of twenty-eight (28) granted United States patents, sixteen (16) pending United States patent applications, two (2) pending Patent Cooperation Treaty international patent applications and granted patents and/or pending applications in several other major markets, including the European Union, Canada and Japan. Our policy is to file United States and foreign patent applications to protect technology, inventions and improvements to inventions that are commercially important to the development of our business. There can be no assurance that any of these patent applications will result in the grant of a patent either in the United States or elsewhere, or that any patents granted will be valid and enforceable, or will provide a competitive advantage or will afford protection against competitors with similar technologies. We also intend to rely upon trade secret rights to protect other technologies that may be used to discover and validate targets and that may be used to identify and develop novel drugs. We seek protection, in part, through confidentiality and proprietary information agreements.
We consider the following United States patents owned by or exclusively licensed to us to be particularly important to the protection of our most advanced product candidates.
Product Candidate | Patent Scope | Patent Expiration | ||
ZYBRESTAT* | Methods of modulating tumor growth or metastasis by administration of combretastatin A-4 phosphate and paclitaxel | December 2021 | ||
| Lyophilized or crystalline combretastatin A-4 phosphate tromethamine | September 2021 | |||
OXi4503** | Composition of matter for combretastatin A-1 (active) | April 2012 | ||
Composition of matter for OXi4503 (combretastatin-A1- disodium-phosphate (OXi4503) pro-drug) | October 2021 |
| * | In-licensed from Bristol-Myers Squibb |
| ** | In-licensed from Arizona State University |
In addition to these patents, for some of our product candidates, we have patents and/or applications that cover a particular form or composition, used as part of combination therapy or method of preparation or use, as well as other pending patent applications. These issued patents, including any patents that issue from pending applications, could provide additional or a longer period of protection. We also have patent applications pending that seek equivalent or substantially comparable protection for our product candidates in jurisdictions internationally that we consider key pharmaceutical markets.
The patent expiration dates referenced above do not reflect any potential patent term extension that we may receive under the federal Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Act. The Hatch-Waxman Act generally permits a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process. Patent extension cannot extend the remaining term of a patent beyond a total of 14 years. The patent term restoration period is generally one-half of the time between the effective date of an investigational new drug application, or IND, and the submission date of a new drug application, or NDA, plus the time between the submission date and approval date of an NDA. Only one patent applicable to an approved drug is eligible for the extension, and the extension must be applied for prior to expiration of the patent. The United States Patent and Trademark Office, in consultation with the FDA, reviews and approves applications for patent term extension.
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The industry in which we are engaged is characterized by rapidly evolving technology and intense competition. Our competitors include, among others, major pharmaceutical, biopharmaceutical and biotechnology companies, many of which have financial, technical and marketing resources significantly greater than ours. In addition, many of the small companies that compete with us have also formed collaborative relationships with large, established companies to support research, development, clinical trials and commercialization of products that may be competitive with ours. Academic institutions, governmental agencies and other public and private research organizations are also conducting research activities and seeking patent protection and may commercialize products on their own or through joint ventures or other collaborations.
We are aware of a limited number of companies involved in the development of VDAs. Such companies include Sanofi-Aventis, Myrexis, Nereus and MediciNova, all of which have VDAs that management believes are at an earlier or similar stage of clinical development than our lead drug candidate, ZYBRESTAT.
We expect that, if any of our products gain regulatory approval for sale, they will compete primarily on the basis of product efficacy, safety, patient convenience, reliability, price and patent protection. Our competitive position will also depend on our ability to attract and retain qualified scientific and other personnel, develop effective proprietary products and implement joint ventures or other alliances with large pharmaceutical companies in order to jointly market and manufacture our products.
We expect to continue to maintain a relatively small number of executives and other employees. We rely on outsourcing much of our research, development, pre-clinical testing and clinical trial activity, although we maintain managerial and quality control over its clinical trials. As of March 9, 2012, we had a total of eight full-time employees and approximately three full-time equivalent employees working on a part-time basis.
| ITEM | 1A. RISK FACTORS |
Statements in this Annual Report under the captions “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as oral statements that may be made by the Company or by officers, directors or employees of the Company acting on the Company’s behalf, that are not historical fact constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of the Company to be materially different from the historical results or from any results expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the risk factors set forth below.
We do not intend to update any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
We will be required to raise additional funds to finance our operations, continue the development of our product candidates and remain a going concern; we may not be able to do so when necessary, and/or the terms of any financings may not be advantageous to us.
Our operations to date have consumed substantial amounts of cash. Negative cash flows from our operations are expected to continue over at least the next several years. Our cash utilization amount is highly dependent on the progress of our product development programs, particularly, the results of our preclinical and clinical studies and those of our partners, the cost, timing and outcomes of regulatory approval for our product candidates, the terms and conditions of our contracts with service providers for these programs, and the rate of recruitment of patients in our human clinical trials. In addition, the further development of our ongoing clinical trials will depend on upcoming analysis and results of those studies and our financial resources at that time.
In addition to our purchase agreement with Lincoln Park Capital, we are aggressively pursuing other forms of capital infusion including public or private financing, strategic partnerships or other arrangements with organizations that have capabilities and/or products that are complementary to our own capabilities and/or
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products, in order to continue the development of our product candidates. However, there can be no assurances that we will complete any strategic alliances or collaborative development agreements, and the terms of such arrangements may not be advantageous to us.
Based on our limited ongoing programs and operations and taking into consideration the expected reductions in cash utilization resulting from our September 2011 reduction in force, we expect our existing cash and cash equivalents to support our operations through the first quarter of 2013. However, this level of cash utilization does not provide for the initiation of any significant projects to further the development of our most advanced product candidates, primarily ZYBRESTAT in ATC. Any significant further development of ZYBRESTAT or other capital intensive activities, including but not limited to the FACT 2 trial, will be contingent upon our ability to raise additional capital in addition to our existing financing arrangements.
Our ongoing capital requirements will depend on numerous factors, including: the progress and results of preclinical testing and clinical trials of our product candidates under development, and in particular whether we initiate the proposed FACT 2 study in ATC; the costs of complying with FDA and other regulatory agency requirements, including addressing findings set forth by the FDA in its correspondence to us in March 2012, which will be significant – as described in the Risk Factors below regarding the conduct of clinical trials and regulatory requirements; the progress of our research and development programs and those of our partners; the time and costs expended and required to obtain any necessary or desired regulatory approvals; the resources, if any, that we devote to develop manufacturing methods and advanced technologies; our ability to enter into licensing arrangements, including any unanticipated licensing arrangements that may be necessary to enable us to continue our development and clinical trial programs; the costs and expenses of filing, prosecuting and, if necessary, enforcing our patent claims, or defending against possible claims of infringement by third-party patent or other technology rights; the cost of commercialization activities and arrangements, if any, undertaken by us; and, if and when approved, the demand for our products, which demand depends in turn on circumstances and uncertainties that cannot be fully known, understood or quantified unless and until the time of approval, including the range of indications for which any product is granted approval.
If we are unable to raise additional funds when needed, we will not be able to continue development of our product candidates or we will be required to delay, scale back or eliminate some or all of our development programs or cease operations. We may seek to raise additional funds through public or private financing, strategic partnerships or other arrangements. Any additional equity financing may be dilutive to our current stockholders and debt financing, if available, may involve restrictive covenants. If we raise funds through collaborative or licensing arrangements, we may be required to relinquish, on terms that are not favorable to us, rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize. Our failure to raise capital when needed will materially harm our business, financial condition and results of operations. Our ability to raise additional capital could also be impaired if our common shares lose their status on The NASDAQ Capital Market. As a result of this uncertainty and the substantial doubt about our ability to continue as a going concern as of December 31, 2011, the Report of Independent Registered Public Accounting Firm at the beginning of the Consolidated Financial Statements section in this Form 10-K includes a going concern explanatory paragraph.
Our facility with LPC will not be sufficient to satisfy our capital requirements for all of our contemplated clinical trials.
In November 2011, we entered into a purchase agreement for the sale, from time to time, of up to $20,000,000 of our common stock with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor. We may direct LPC to purchase up to $20,000,000 worth of shares of our common stock under our agreement over a 36-month period, in amounts of up to $200,000, which amounts may be increased under certain circumstances. We will not have the ability to sell shares under this arrangement if we fail to maintain a minimum stock price or if we fail to maintain the effectiveness of a registration statement filed with the Securities and Exchange Commission. In addition, as a result of Nasdaq rules, we cannot sell Lincoln Park more than 2,974,483 shares of our common stock, representing 19.9% of our outstanding shares at the time we entered into the Lincoln Park facility in November 2011, at an average price per share that is less than $1.3051 (the deemed market value per share of our common stock for purposes of the agreement). At our current stock price,
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this would mean that we cannot access more than approximately $3 million of the $20 million in potential proceeds under the Lincoln Park facility without obtaining shareholder approval, which we intend to do at our 2012 annual meeting of shareholders. The funding available from LPC may not be available when needed, or at all, depending on the market price of our common stock.
The extent to which we rely on LPC as a source of funding will depend on a number of factors, including the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources. If obtaining sufficient funding from LPC were to prove impracticable or prohibitively dilutive, we will need to secure another source of funding in order to satisfy our working capital needs. Even if we sell the maximum amount we are eligible to sell to LPC under the purchase agreement, we will still need additional capital to fully implement our business, operating and development plans. Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences would have a material adverse effect on our business, operating results, financial condition and prospects.
Due in part to our constrained financial resources, we may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable indications or therapeutic areas for our product candidates or those that are in-licensed, and/or we may be unable to pursue the clinical trials that we would like to pursue.
We have limited technical, managerial and financial resources to determine the indications on which we should focus the development efforts related to our product candidates. Due to our limited available financial resources, we have had to curtail clinical development programs and activities that might otherwise have led to more rapid progress of our product candidates through the regulatory and development processes. For example, in February 2010 we announced a restructuring of our clinical development programs. As a part of that restructuring, we stopped enrollment in our FACT trial and have redirected available resources away from other clinical trial programs in favor of those we believe to have the highest value. In addition, in September 2011, we implemented a reduction in force, and now have only a limited number of employees to manage and operate our business and clinical programs.
We intend to pursue a second clinical trial of ZYBRESTAT in ATC, but our current financial resources are insufficient to allow us to do so without substantial additional funding. Due to the rarity of ATC, which afflicts only approximately 4,000 people worldwide per year, and the fact that the median length of survival from time of diagnosis for patients with ATC is only approximately 3-4 months, our strategy is to recruit patients to a large number of clinical trial sites to participate in the trial. This clinical trial will be extremely costly and time-consuming, and we cannot assure you that the results of this trial will be sufficient to form the basis of a successful new drug application or that we will have sufficient financial resources to allow us to complete the trial.
We may make incorrect determinations with regard to the indications and clinical trials on which to focus the available resources that we do have. Furthermore, we cannot assure you that we will be able to retain adequate staffing levels to run our operations and/or to accomplish all of the objectives that we otherwise would seek to accomplish. The decisions to allocate our research, management and financial resources toward particular indications or therapeutic areas for our product candidates may not lead to the development of viable commercial products and may divert resources from better opportunities. Similarly, our decisions to delay or terminate drug development programs may also cause us to miss valuable opportunities. In addition, from time to time, we may in-license or otherwise acquire product candidates to supplement our internal development activities. Those activities may use resources that otherwise would have been devoted to our internal programs. We cannot assure you that any resources that we devote to acquired or in-licensed programs will result in any products that are superior to our internally developed products.
If we or the third parties on which we rely for the conduct of our clinical trials and results do not perform our clinical trial activities in accordance with good clinical practices and related regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates.
We use independent clinical investigators and, in many cases, contract research organizations and other third-party service providers to conduct and/or oversee the clinical trials of our product candidates and expect to continue to do so. We rely heavily on these parties for successful execution of our clinical trials. Nonetheless, we
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are responsible for confirming that each of our clinical trials is conducted in accordance with the FDA’s requirements and our general investigational plan and protocol. Currently our only clinical trial activities involving ZYBRESTAT are being conducted by physician clinical investigators who are independent of us, but with whom we have agreements for them to provide the results of their clinical trials to us. In order for us to rely on data from these ongoing studies in support of a marketing application, or NDA, for approval of any of our product candidates by the FDA or other regulatory authorities, the independent investigators are required to comply with FDA requirements applicable to their studies.
The FDA and corresponding foreign regulatory authorities require us and our clinical investigators to comply with regulations and standards, commonly referred to as good clinical practices, for conducting and recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the trial participants are adequately protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. Third parties may not complete activities on schedule or may not conduct our clinical trials in accordance with regulatory requirements or the respective trial plans and protocols. The failure of these third parties to carry out their obligations could delay or prevent the development, approval and commercialization of our product candidates or result in enforcement action against us.
In February 2012, we were inspected by the FDA, and in March 2012, we received a Form FDA 483 containing observations from that inspection. The Form FDA 483 noted observations of certain deficiencies in the conduct of our FACT trial in ATC, which was conducted from July 2007 – February 2010. These observations related to the FDA’s good clinical practice requirements and included the failure to insure proper monitoring of third party clinical investigators who were participants in our FACT trial, the failure to promptly bring non-compliant clinical investigators into compliance, and the selection of clinical trial monitors by our clinical research organizations, or CROs, outside the United States who were not sufficiently qualified by experience and training to monitor clinical trials. The Form FDA 483 also included observations related to the failure to address the improper storage of a drug that was being used in the trial, and the failure to maintain records and case histories in compliance with FDA regulations. The issues noted in the Form FDA 483 had previously been identified and addressed by our management as part of an internal review, first disclosed by us in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, of our systems, practices and procedures governing the areas of vendor oversight, quality, and regulatory compliance.
Our response to the Form FDA 483 describes the corrective actions that we have taken and will continue to take in response to this matter. While we have taken steps and are taking further steps promptly to strengthen our procedures in order to ensure that these issues will not recur in any future clinical trials sponsored by us for any of our product candidates, we cannot assure you that the FDA will be satisfied with our response, that the FDA will not issue a warning letter or take other enforcement action against us, or that similar issues will not recur in the future. The results of this inspection may cause the FDA to disqualify some or all of the data from the FACT trial and not consider it in any future NDA for ZYBRESTAT, which could result in delays or difficulties in obtaining the regulatory approvals that will be required to market ZYBRESTAT. In addition, the steps we take to strengthen our procedures and conduct future clinical trials necessary for approval will be time-consuming and expensive, and we believe, but cannot assure you, that those steps will be sufficient to address the issues that were identified by the FDA in the Form FDA 483.
Our product candidates have not completed clinical trials, and may never demonstrate sufficient safety and efficacy in order to do so.
Our product candidates are in an early stage of development. In order to achieve profitable operations, we alone or in collaboration with others, must successfully develop, manufacture, introduce and market our products. The time frame necessary to achieve market success for any individual product is long and uncertain. The products currently under development by us will require significant additional research and development and extensive preclinical and clinical testing prior to application for commercial use. A number of companies in the biotechnology and pharmaceutical industries have suffered significant setbacks in clinical trials, even after showing promising results in early or later-stage studies or clinical trials. Although we have obtained some favorable results to-date in preclinical studies and clinical trials of certain of our potential products, such results may not be indicative of results that will ultimately be obtained in or throughout such clinical trials, and clinical trials may not show any of our
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products to be safe or capable of producing a desired result. Additionally, we may encounter problems in our clinical trials that will cause us to delay, suspend or terminate those clinical trials. Further, our research or product development efforts may not be successfully completed, any compounds currently under development by us may not be successfully developed into drugs, any potential products may not receive regulatory approval on a timely basis, if at all, and competitors may develop and bring to market products or technologies that render our potential products obsolete. If any of these problems occur, our business would be materially and adversely affected.
We have only a limited number of employees to manage and operate our business.
As announced on September 1, 2011, we have implemented a restructuring plan designed to focus our capital resources on our most promising early-stage clinical programs and further reduce our cash utilization. This restructuring plan involved a reduction in force of 11 full-time equivalent employees, or approximately 61%. As of March 9, 2012, we had a total of eight full-time employees and approximately three full-time equivalent employees working on a part-time basis. This reduction in force and focus on reducing cash utilization requires us to manage and operate our business in a highly efficient manner. We cannot assure you that we will be able to retain adequate staffing levels to run our operations and/or to accomplish all of the objectives that we otherwise would seek to accomplish.
We have a history of losses, and we anticipate that we will continue to incur losses in the future.
We have experienced net losses every year since our inception and, as of December 31, 2011, had an accumulated deficit of approximately $217,353,000. We anticipate continuing to incur substantial additional losses over at least the next several years due to, among other factors, the need to expend substantial amounts on our continuing clinical trials with respect to our VDA drug candidates, technologies, and anticipated research and development activities and the general and administrative expenses associated with those activities. We have not commercially introduced any product and our potential products are in varying early stages of development and testing. Our ability to attain profitability will depend upon our ability to develop products that are effective and commercially viable, to obtain regulatory approval for the manufacture and sale of our products and to license or otherwise market our products successfully. We may never achieve profitability, and even if we do, we may not be able to sustain being profitable.
We depend heavily on our executive officers, directors, and principal consultants and the loss of their services would materially harm our business.
We believe that our success depends, and will likely continue to depend, upon our ability to retain the services of our current executive officers, directors, principal consultants and others. The loss of the services of any of these individuals would have a material adverse effect on our business. In addition, we have established relationships with universities, hospitals and research institutions, which have historically provided, and continue to provide, us with access to research laboratories, clinical trials, facilities and patients. Additionally, we believe that we may, at any time and from time to time, materially depend on the services of consultants and other unaffiliated third parties. We cannot assure you that consultants and other unaffiliated third parties will provide the level of service to us that we require in order to achieve our business objectives.
Our industry is highly competitive, and our products may become technologically obsolete.
We are engaged in a rapidly evolving field. Competition from other pharmaceutical companies, biotechnology companies and research and academic institutions is intense and expected to increase. Many of those companies and institutions have substantially greater financial, technical and human resources than we do. Those companies and institutions also have substantially greater experience in developing products, in conducting clinical trials, in obtaining regulatory approval and in manufacturing and marketing pharmaceutical products. Our competitors may succeed in obtaining regulatory approval for their products more rapidly than we do. Competitors have developed or are in the process of developing technologies that are, or in the future may be, the basis for competitive products. We are aware of at least one other company that currently has a clinical-stage VDA for use in an oncology indication. Some of these competitive products may have an entirely different approach or means of accomplishing the desired therapeutic effect than products being developed by us. Our
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competitors may succeed in developing technologies and products that are more effective and/or cost competitive than those we are developing, or that would render our technology and products less competitive or even obsolete. In addition, one or more of our competitors may achieve product commercialization or patent protection earlier than we do, which could materially adversely affect us.
We have licensed in rights to ZYBRESTAT, OXi4503 and other programs from third parties. If our license agreements terminate or expire, we may lose the licensed rights to our product candidates, including ZYBRESTAT and OXi4503, and we may not be able to continue to develop them or, if they are approved, market or commercialize them.
We depend on license agreements with third parties for certain intellectual property rights relating to our product candidates, including patent rights. Currently, we have licensed in patent rights from Arizona State University, or ASU, and the Bristol-Myers Squibb Company for ZYBRESTAT and OXi4503 and from Baylor University for other programs. In general, our license agreements require us to make payments and satisfy performance obligations in order to keep these agreements in effect and retain our rights under them. These payment obligations can include upfront fees, maintenance fees, milestones, royalties, patent prosecution expenses, and other fees. These performance obligations typically include diligence obligations. If we fail to pay, be diligent or otherwise perform as required under our license agreements, we could lose the rights under the patents and other intellectual property rights covered by the agreements. While we are not currently aware of any dispute with any licensors under our material agreements with them, if disputes arise under any of our in-licenses, including our in-licenses from ASU and the Bristol-Myers Squibb Company, and Baylor University, we could lose our rights under these agreements. Any such disputes may or may not be resolvable on favorable terms, or at all. Whether or not any disputes of this kind are favorably resolved, our management’s time and attention and our other resources could be consumed by the need to attend to and seek to resolve these disputes and our business could be harmed by the emergence of such a dispute.
If we lose our rights under these agreements, we may not be able to conduct any further activities with the product candidate or program that the license covered. If this were to happen, we might not be able to develop our product candidates further, or following regulatory approval, if any, we might be prohibited from marketing or commercializing them. In particular, patents previously licensed to us might after termination be used to stop us from conducting these activities.
We depend extensively on our patents and proprietary technology, and we must protect those assets in order to preserve our business.
Although we expect to seek patent protection for any compounds we discover and/or for any specific use we discover for new or previously known compounds, any or all of them may not be subject to effective patent protection. Further, the development of regimens for the administration of pharmaceuticals, which generally involve specifications for the frequency, timing and amount of dosages, has been, and we believe, may continue to be, important to our effort, although those processes, as such, may not be patentable. In addition, the issued patents may be declared invalid or our competitors may find ways to avoid the claims in the patents.
Our success will depend, in part, on our ability to obtain patents, protect our trade secrets and operate without infringing on the proprietary rights of others. As of March 9, 2012, we were the exclusive licensee, sole assignee or co-assignee of twenty-eight (28) granted United States patents, sixteen (16) pending United States patent applications, two (2) pending Patent Cooperation Treaty international patent applications, and granted patents and/or pending applications in several other major markets, including the European Union, Canada and Japan. The patent position of pharmaceutical and biotechnology firms like us are generally highly uncertain and involves complex legal and factual questions, resulting in both an apparent inconsistency regarding the breadth of claims allowed in United States patents and general uncertainty as to their legal interpretation and enforceability. Accordingly, patent applications assigned or exclusively licensed to us may not result in patents being issued, any issued patents assigned or exclusively licensed to us may not provide us with competitive protection or may be challenged by others, and the current or future granted patents of others may have an adverse effect on our ability to do business and achieve profitability. Moreover, since some of the basic research relating to one or more of our patent applications and/or patents were performed at various universities and/or funded by grants,
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one or more universities, employees of such universities and/or grantors could assert that they have certain rights in such research and any resulting products. Further, others may independently develop similar products, may duplicate our products, or may design around our patent rights. In addition, as a result of the assertion of rights by a third party or otherwise, we may be required to obtain licenses to patents or other proprietary rights of others in or outside of the United States. Any licenses required under any such patents or proprietary rights may not be made available on terms acceptable to us, if at all. If we do not obtain such licenses, we could encounter delays in product market introductions while our attempts to design around such patents or could find that the development, manufacture or sale of products requiring such licenses is foreclosed. In addition, we could incur substantial costs in defending ourselves in suits brought against us or in connection with patents to which we hold licenses or in bringing suit to protect our own patents against infringement.
We require employees and the institutions that perform our preclinical and clinical trials to enter into confidentiality agreements with us. Those agreements provide that all confidential information developed or made known to the individual during the course of the relationship with us to be kept confidential and not to be disclosed to third parties, except in specific circumstances. Any such agreement may not provide meaningful protection for our trade secrets or other confidential information in the event of unauthorized use or disclosure of such information.
Our products may result in product liability exposure, and it is uncertain whether our insurance coverage will be sufficient to cover all claims.
The use of our product candidates in clinical trials and for commercial applications, if any, may expose us to liability claims, in the event such product candidates cause injury or disease, or result in adverse effects. These claims could be made directly by health care institutions, contract laboratories, patients or others using such products. Although we have obtained liability insurance coverage for our ongoing clinical trials, this coverage may not be in amounts sufficient to protect us from any product liability claims or product recalls which could have a material adverse effect on our financial condition and prospects. Further, adverse product and similar liability claims could negatively impact our ability to obtain or maintain regulatory approvals for our technology and product candidates under development.
If we do not obtain required regulatory approvals, we will be unable to market and sell our product candidates.
Our product candidates are subject to extensive governmental regulations relating to development, clinical trials, manufacturing, oversight of clinical investigators, recordkeeping and commercialization. Rigorous preclinical testing and clinical trials and an extensive regulatory review and approval process are required to be successfully completed in the United States and in many foreign jurisdictions before a new drug can be sold. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain, and subject to unanticipated delays. The time required to obtain approval by the FDA is unpredictable but typically exceeds five years following the commencement of clinical trials, depending upon the complexity of the product candidate.
We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including approval by the FDA. In connection with the clinical trials of our product candidates, we face risks that:
| Ÿ | the product candidate may not prove to be safe and efficacious; |
| Ÿ | patients may die or suffer serious adverse effects for reasons that may or may not be related to the product candidate being tested; |
| Ÿ | we fail to maintain adequate records of observations and data from our clinical trials, to establish and maintain sufficient procedures to oversee, collect data from, and manage clinical trials, or to monitor clinical trial sites and investigators to the satisfaction of the FDA or other regulatory agencies; |
| Ÿ | the results of later-phase clinical trials may not confirm the results of earlier clinical trials; and |
| Ÿ | the results may not meet the level of statistical significance or clinical benefit-to-risk ratio required by the FDA or other regulatory agencies for marketing approval. |
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Only a small percentage of product candidates for which clinical trials are initiated are the subject of NDAs and even fewer receive approval for commercialization. Furthermore, even if we do receive regulatory approval to market a product candidate, any such approval may be subject to limitations such as those on the indicated uses for which we may market the product.
If clinical trials for our product candidates are prolonged, delayed or suspended, we may be unable to commercialize our product candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any revenue from potential product sales.
We cannot predict whether we will encounter problems with any of our completed, ongoing or planned clinical trials that will cause us or any regulatory authority to delay or suspend those clinical trials or delay the analysis of data derived from them. A number of events, including any of the following, could delay the completion of our other ongoing and planned clinical trials and negatively impact our ability to obtain regulatory approval for, and to market and sell, a particular product candidate:
| Ÿ | conditions imposed on us by the FDA or any foreign regulatory authority regarding the scope or design of our clinical trials; |
| Ÿ | delays in obtaining, or our inability to obtain, required approvals from institutional review boards or other reviewing entities at clinical sites selected for participation in our clinical trials; |
| Ÿ | insufficient supply of our product candidates or other materials necessary to conduct and complete our clinical trials; |
| Ÿ | slow enrollment and retention rate of subjects in clinical trials; |
| Ÿ | failure to achieve compliance with the FDA requirements noted in the agency’s March 2012 letter to us regarding certain observations about our FACT trial in ATC; |
| Ÿ | negative or inconclusive results from clinical trials, or results that are inconsistent with earlier results; |
| Ÿ | serious and unexpected drug-related side effects; and |
| Ÿ | failure of our third-party contractors to comply with regulatory requirements or otherwise meet their contractual obligations to us. |
Commercialization of our product candidates may be delayed by the imposition of additional conditions on our clinical trials by the FDA or any foreign regulatory authority or the requirement of additional supportive studies by the FDA or any foreign regulatory authority. In addition, clinical trials require sufficient patient enrollment, which is a function of many factors, including the size of the patient population, the nature of the trial protocol, the proximity of patients to clinical sites, the availability of effective treatments for the relevant disease, the conduct of other clinical trials that compete for the same patients as our clinical trials, and the eligibility criteria for our clinical trials. Our failure to enroll patients in our clinical trials could delay the completion of the clinical trial beyond our expectations. In addition, the FDA could require us to conduct clinical trials with a larger number of subjects than we have projected for any of our product candidates. We may not be able to enroll a sufficient number of patients in a timely or cost-effective manner. Furthermore, enrolled patients may drop out of our clinical trials, which could impair the validity or statistical significance of the clinical trials.
We do not know whether our clinical trials will begin as planned, will need to be restructured, or will be completed on schedule, if at all. Delays in our clinical trials will result in increased development costs for our product candidates, and our financial resources may be insufficient to fund any incremental costs. In addition, if our clinical trials are delayed, our competitors may be able to bring products to market before we do and the commercial viability of our product candidates could be limited.
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Our product candidates will remain subject to ongoing regulatory review even if they receive marketing approval, and if we fail to comply with continuing regulations, we could lose these approvals and the sale of any approved commercial products could be suspended.
Even if we receive regulatory approval to market a particular product candidate, the manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, and record keeping related to the product will remain subject to extensive regulatory requirements. If we fail to comply with the regulatory requirements of the FDA and other applicable domestic and foreign regulatory authorities or previously unknown problems with any approved product, manufacturer, or manufacturing process is discovered, we could be subject to administrative or judicially imposed sanctions, including:
| Ÿ | restrictions on the products, manufacturers, or manufacturing processes; |
| Ÿ | warning letters; |
| Ÿ | civil or criminal penalties; |
| Ÿ | fines; |
| Ÿ | injunctions; |
| Ÿ | product seizures or detentions; |
| Ÿ | pressure to initiate voluntary product recalls; |
| Ÿ | suspension or withdrawal of regulatory approvals; and |
| Ÿ | refusal to approve pending applications for marketing approval of new products or supplements to approved applications. |
If physicians and patients do not accept our future products or if the market for indications for which any product candidate is approved is smaller than expected, we may be unable to generate significant revenue, if any.
Even if any of our product candidates obtain regulatory approval, they may not gain market acceptance among physicians, patients, and third-party payers. Physicians may decide not to recommend our drugs for a variety of reasons including:
| Ÿ | timing of market introduction of competitive products; |
| Ÿ | demonstration of clinical safety and efficacy compared to other products; |
| Ÿ | cost-effectiveness; |
| Ÿ | limited or no coverage by third-party payers; |
| Ÿ | convenience and ease of administration; |
| Ÿ | prevalence and severity of adverse side effects; |
| Ÿ | restrictions in the label of the drug; |
| Ÿ | other potential advantages of alternative treatment methods; and |
| Ÿ | ineffective marketing and distribution support of our products. |
If any of our product candidates are approved, but fail to achieve market acceptance, we may not be able to generate significant revenue and our business would suffer.
We have no manufacturing capacity, and have relied and expect to continue to rely on third-party manufacturers to produce our product candidates.
We do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our product candidates or any of the compounds that we are testing in our preclinical programs, and we lack the
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resources and the capabilities to do so. As a result, we currently rely, and we expect to rely in the future, on third-party manufacturers to supply our product candidates. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured our product candidates or products ourselves, including:
| Ÿ | reliance on the third party for manufacturing process development, regulatory compliance and quality assurance; |
| Ÿ | limitations on supply availability resulting from capacity and scheduling constraints of the third party; |
| Ÿ | the possible breach of the manufacturing agreement by the third party because of factors beyond our control; and |
| Ÿ | the possible termination or non-renewal of the agreement by the third party, based on our own business priorities, at a time that is costly or inconvenient for us. |
If we do not maintain our developed important manufacturing relationships, we may fail to find replacement manufacturers 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, 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 new facilities could be qualified and registered with the FDA and foreign regulatory authorities.
The FDA and foreign regulatory authorities require manufacturers to register manufacturing facilities. The FDA and corresponding foreign regulators also inspect these facilities to confirm compliance with current good manufacturing practices, or cGMPs. Contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements. Any failure to comply with cGMP requirements or other FDA and comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop our product candidates and market our products after approval.
Our current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to develop our product candidates and commercialize any products that receive regulatory approval on a timely basis.
The uncertainty associated with pharmaceutical reimbursement and related matters may adversely affect our business.
Market acceptance and sales of any one or more of our product candidates that we develop will depend on reimbursement policies and may be affected by future healthcare reform measures. Government authorities and third-party payers, such as private health insurers and health maintenance organizations, decide which drugs they will cover and establish payment levels. We cannot be certain that reimbursement will be available for any product candidates that we develop. Also, we cannot be certain that reimbursement policies will not reduce the demand for, or the price paid for, our products. If reimbursement is not available or is available on a limited basis, we may not be able to successfully commercialize any product candidates that we develop.
In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, also called the Medicare Modernization Act, or MMA, changed the way Medicare covers and pays for pharmaceutical products. The legislation established Medicare Part D, which expanded Medicare coverage for outpatient prescription drug purchases by the elderly but provided authority for limiting the number of drugs that will be covered in any therapeutic class. The MMA also introduced a new reimbursement methodology based on average sales prices for physician-administered drugs.
The United States and several foreign jurisdictions are considering, or have already enacted, a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably. Among policy makers and payers in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access to healthcare. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. We
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expect to experience pricing pressures in connection with the sale of any products that we develop due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative proposals.
In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively, ACA, became law in the U.S. The goal of ACA is to reduce the cost of health care and substantially change the way health care is financed by both government and private insurers. While we cannot predict what impact on federal reimbursement policies this legislation will have in general or on our business specifically, the ACA may result in downward pressure on pharmaceutical reimbursement, which could negatively affect market acceptance of our product candidates. Members of the U.S. Congress and some state legislatures are seeking to overturn at least portions of the legislation, and we expect they will continue to review and assess this legislation and possibly alternative health care reform proposals. We cannot predict whether new proposals will be made or adopted, when they may be adopted or what impact they may have on us if they are adopted.
Our restated certificate of incorporation, our amended and restated by-laws, our stockholder rights agreement and Delaware law could deter a change of our management which could discourage or delay offers to acquire us.
Certain provisions of Delaware law and of our restated certificate of incorporation, as amended, and amended and restated by-laws could discourage or make it more difficult to accomplish a proxy contest or other change in our management or the acquisition of control by a holder of a substantial amount of our voting stock. It is possible that these provisions could make it more difficult to accomplish, or could deter, transactions that stockholders may otherwise consider to be in their best interests or the best interests of us. Further, the rights issued under the stockholder rights agreement would cause substantial dilution to a person or group that attempts to acquire us on terms not approved in advance by our Board of Directors.
The price of our common stock is volatile, and is likely to continue to fluctuate due to reasons beyond our control.
The market price of our common stock has been, and likely will continue to be, highly volatile. Factors, including our financial results or our competitors’ financial results, clinical trial and research development announcements and government regulatory action affecting our potential products in both the United States and foreign countries, have had, and may continue to have, a significant effect on our results of operations and on the market price of our common stock. We cannot assure you that your investment in our common stock will not fluctuate significantly. One or more of these factors could significantly harm our business and cause a decline in the price of our common stock in the public market. Substantially all of the shares of our common stock issuable upon exercise of outstanding options and warrants have been registered for resale or are available for sale pursuant to Rule 144 under the Securities Act of 1933, as amended, and may be sold from time to time. Such sales, as well as future sales of our common stock by existing stockholders, or the perception that sales may occur at any time, could adversely affect the market price of our common stock.
| ITEM | 1B. UNRESOLVED STAFF COMMENTS |
None.
| ITEM | 2. PROPERTIES |
OXiGENE’s corporate headquarters is located in South San Francisco, California where it leases approximately 12,000 square feet of general office space. The initial term of the lease expires on April 30, 2013. In addition, OXiGENE leases approximately 2,500 square feet of general office space located in Waltham, Massachusetts. The lease expires on May 31, 2012. The Company will not extend the lease of its Waltham office.
| ITEM | 3. LEGAL PROCEEDINGS |
None.
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| ITEM | 4. MINE SAFETY DISCLOSURES |
Not applicable
| ITEM 5. | MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES |
The Company’s common stock is traded on The NASDAQ Capital Market under the symbol “OXGN.” Prior to March 3, 2011, OXiGENE’s common stock was traded on The NASDAQ Global Market under the symbol “OXGN.” The following table sets forth the high and low sales price per share for our common stock on The NASDAQ Global Market and The NASDAQ Capital Market, as applicable, for each quarterly period during the two most recent fiscal years and subsequent interim periods.
In February 2011, the Company’s board of directors voted unanimously to implement a 1:20 reverse stock split of the Company’s common stock, following authorization of the reverse split by a shareholder vote on December 21, 2010. The reverse split became effective on February 22, 2011. All of the per share sales prices shown in the table below have been adjusted to reflect the effect of this reverse split.
| Fiscal Year 2011 | Fiscal Year 2010 | |||||||||||||||
| High | Low | High | Low | |||||||||||||
First Quarter | $ | 5.20 | $ | 1.69 | $ | 27.60 | $ | 20.00 | ||||||||
Second Quarter | $ | 6.38 | $ | 1.52 | $ | 26.40 | $ | 7.40 | ||||||||
Third Quarter | $ | 2.65 | $ | 1.00 | $ | 11.00 | $ | 5.20 | ||||||||
Fourth Quarter | $ | 1.97 | $ | 0.82 | $ | 6.00 | $ | 3.80 | ||||||||
On March 22, 2012, the closing price of the Company’s common stock on The NASDAQ Capital Market was $1.05 per share.
As of March 9, 2012, there were approximately 90 stockholders of record of the approximately 15,956,000 outstanding shares of the Company’s common stock. The Company believes, based on the number of proxy statements and related materials distributed in connection with its 2011 Special Meeting of Stockholders, that there are approximately 6,000 beneficial owners of its common stock.
The Company has not declared or paid any cash dividends on its common stock since its inception in 1988, and does not intend to pay cash dividends in the foreseeable future. The Company presently intends to retain future earnings, if any, to finance the growth and development of its business.
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| ITEM | 6. SELECTED FINANCIAL DATA |
SUMMARY FINANCIAL INFORMATION
The following table sets forth financial data with respect to the Company for each of the five years in the period ended December 31, 2011. The selected financial data for each of the five years in the period ended December 31, 2011 has been derived from the audited financial statements of the Company. The information below should be read in conjunction with the financial statements (and notes thereto) and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in Item 7 of this Annual Report on Form 10-K.
In February 2011, the Company’s board of directors voted unanimously to implement a 1:20 reverse stock split of the Company’s common stock, following authorization of the reverse split by a shareholder vote on December 21, 2010. The reverse split became effective on February 22, 2011. All of the share and per share amounts discussed and shown in the statements and tables below have been adjusted to reflect the effect of this reverse split.
| Years ended December 31, | ||||||||||||||||||||
| 2011 | 2010 | 2009 | 2008 | 2007 | ||||||||||||||||
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STATEMENT OF OPERATIONS DATA: | ||||||||||||||||||||
License Revenue: | $ | — | $ | — | $ | — | $ | 12 | $ | 12 | ||||||||||
Operating costs and expenses: | ||||||||||||||||||||
Research and development | 5,291 | 12,114 | 22,256 | 18,995 | 14,511 | |||||||||||||||
General and administrative | 5,375 | 5,885 | 8,900 | 6,957 | 7,774 | |||||||||||||||
Restructuring | 1,226 | 510 | — | — | — | |||||||||||||||
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Total operating costs and expenses | 11,892 | 18,509 | 31,156 | 25,952 | 22,285 | |||||||||||||||
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Loss from operations | (11,892 | ) | (18,509 | ) | (31,156 | ) | (25,940 | ) | (22,273 | ) | ||||||||||
Change in fair value of warrants and other financial instruments | 2,222 | (6,018 | ) | 2,166 | 3,335 | — | ||||||||||||||
Investment income | 7 | 17 | 110 | 618 | 1,955 | |||||||||||||||
Other income (expense), net | 10 | 740 | (63 | ) | 66 | (71 | ) | |||||||||||||
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Consolidated net loss | $ | (9,653 | ) | $ | (23,770 | ) | $ | (28,943 | ) | $ | (21,921 | ) | $ | (20,389 | ) | |||||
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Net loss attributed to non controlling | $ | — | $ | — | $ | (4,215 | ) | $ | (520 | ) | $ | — | ||||||||
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Net loss attributed to OXiGENE, Inc. | $ | (9,653 | ) | $ | (23,770 | ) | $ | (24,728 | ) | $ | (21,401 | ) | $ | (20,389 | ) | |||||
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Excess purchase price over carrying value of noncontrolling interest acquired in Symphony ViDA, Inc | $ | — | $ | — | $ | (10,383 | ) | $ | — | $ | — | |||||||||
Net loss applicable to common stock | $ | (9,653 | ) | $ | (23,770 | ) | $ | (35,111 | ) | $ | (21,401 | ) | $ | (20,389 | ) | |||||
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Basic and diluted net loss per share attributed to OXiGENE, Inc. common shares | $ | (0.86 | ) | $ | (5.96 | ) | $ | (13.15 | ) | $ | (13.96 | ) | $ | (14.60 | ) | |||||
Weighted-average number of common shares outstanding | 11,167 | 3,988 | 2,671 | 1,533 | 1,397 | |||||||||||||||
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| 2011 | 2010 | 2009 | 2008 | 2007 | ||||||||||||||||
| (Amounts in thousands except per share amounts) | ||||||||||||||||||||
BALANCE SHEET DATA: | ||||||||||||||||||||
Cash, restricted cash and equivalents and available-for-sale securities | $ | 9,992 | $ | 4,677 | $ | 14,072 | $ | 18,918 | $ | 28,438 | ||||||||||
Marketable securities held by Symphony ViDA, Inc., restricted | — | — | — | 14,663 | — | |||||||||||||||
Working capital | 8,394 | 1,797 | 6,356 | 28,320 | 23,880 | |||||||||||||||
Total assets | 11,056 | 5,567 | 15,617 | 35,031 | 30,064 | |||||||||||||||
Total liabilities | 2,259 | 10,822 | 9,818 | 6,292 | 5,207 | |||||||||||||||
Accumulated deficit | (217,353 | ) | (207,700 | ) | (183,930 | ) | (159,202 | ) | (137,801 | ) | ||||||||||
Noncontrolling interest | — | — | — | 9,432 | — | |||||||||||||||
Total stockholders’ equity (deficit) | $ | 8,797 | $ | (5,255 | ) | $ | 5,799 | $ | 28,739 | $ | 24,857 | |||||||||
| (1) | The amount related to loss attributed to non controlling interest in Symphony ViDA, Inc. represents the loss for the Symphony ViDA, Inc. entity from its inception in October 2008 through the acquisition of the entity in July 2009. The investments reported as held by Symphony ViDA, Inc. represented the fair value of amounts held by Symphony ViDA, Inc. and were included in the acquisition. |
| ITEM | 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Our management’s discussion and analysis of financial condition contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks and uncertainties that may cause our actual results or outcomes to be materially different from those anticipated and discussed herein. Important factors that we believe may cause such differences are discussed in the “Risk Factors” section of this Annual Report and in the cautionary statements accompanying the forward-looking statements in this Annual Report. In assessing forward-looking statements contained herein, readers are urged to read carefully all Risk Factors and cautionary statements contained in this Annual Report. Further, we operate in an industry sector where securities values are volatile and may be influenced by regulatory and other factors beyond our control.
We are a clinical-stage, biopharmaceutical company developing novel therapeutics primarily to treat cancer. Our primary focus is the development of product candidates referred to as vascular disrupting agents, or VDAs, that selectively disable and destroy abnormal blood vessels that provide solid tumors a means of growth and survival and also are associated with visual impairment in a number of ophthalmological diseases and conditions.
| • | We intend to primarily target the development of our product candidates for the treatment of rare cancers that will be eligible for orphan drug status from the Food and Drug Administration, or FDA. Our lead candidate, ZYBRESTAT, has been awarded orphan drug status by the FDA and the European Commission in the European Union for the treatment of advanced anaplastic thyroid cancer, or ATC, and for the treatment of medullary, Stage IV papillary and Stage IV follicular thyroid cancers. The FDA has also granted Fast Track status to ZYBRESTAT for the treatment of regionally advanced and/or metastatic ATC, as well as in ovarian cancer. |
The Orphan Drug Act was passed in January 1983 to stimulate the research, development, and approval of products that treat rare diseases. An orphan drug is defined as a product that treats a rare disease affecting fewer than 200,000 patients in the United States. Drugs are granted orphan status for a specific indication.
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To date, more than 400 subjects have been treated with ZYBRESTAT in human clinical trials, and the drug candidate has generally been observed to be well-tolerated.
ZYBRESTAT for Oncology
ZYBRESTAT is a reversible tubulin binding agent that works by disrupting the network of blood vessels, or vasculature, within solid tumors, also referred to as vascular disruption. Vascular disruption leads to tumor hypoxia, which refers to the process of starving the tumor of vitally necessary oxygen supply and subsequent tumor cell death. More specifically, ZYBRESTAT selectively targets the existing abnormal and largely immature vasculature found specifically in most solid tumors and causes endothelial cells that make up the walls of the blood vessels in that vasculature to lose their normally flat shape and to become round, thus blocking the flow of blood to the tumor. The downstream tumor environment is then deprived of oxygen and nutrients, and the resulting restriction in blood supply kills the cells in the central portion of the tumor. Based on ZYBRESTAT’s positive activity observed in animal models, we have conducted multiple clinical trials of ZYBRESTAT in a variety of tumor types.
Our top priority is to pursue the clinical development of ZYBRESTAT in ATC. ATC is a very aggressive, rare but lethal cancer of the thyroid gland. Because of the rapid progression of the disease and the absence of effective therapies, median survival from the time of diagnosis is approximately 3-4 months. We have completed a Phase 2/3 clinical trial of ZYBRESTAT in patients with ATC, and we are currently planning a pivotal Phase 3 clinical trial of ZYBRESTAT in ATC, which we refer to as the FACT 2 trial. We believe that the FACT 2 trial represents a critical opportunity to demonstrate the value of our key asset, ZYBRESTAT, and has the potential to create significant value for our company and our shareholders. As such, our primary corporate strategy for 2012 is to secure sufficient funding to conduct the trial. We also intend to pursue a special protocol assessment (SPA) for this program with the FDA, with the goal of laying the foundation for initiation of this global registration study. We believe completion of the FACT2 study, assuming continued positive clinical results, will be sufficient to obtain FDA approval and approval in Europe for the treatment of patients with advanced ATC.
Possible areas for future development
ATC and ovarian cancer, and potentially other orphan indications, represent areas for further development and significant unmet medical needs, and thus significant potential commercial market opportunities.
Further development of our ongoing clinical trials will depend on continuing analysis and results of ongoing clinical studies, as well as available financial resources and/or potential partnering activities.
OXi4503, a unique, second generation VDA for oncology indications
We are currently pursuing development of OXi4503, a second-generation, dual-mechanism VDA, as a treatment for certain solid tumor types and for the treatment of myeloid leukemias, which also represent orphan indications. We believe that OXi4503 is differentiated from other VDAs by its dual-action activity: in addition to having potent vascular disrupting effects, OXi4503 is unique in that certain enzymes in the human body can help convert it to a form of chemical that has direct tumor cell killing effects. We believe this unique property may result in enhanced anti-tumor activity in certain tumor types as compared with other VDA drug candidates. Based on data from preclinical studies, we believe that OXi4503 may have enhanced activity in tumor types with relatively high levels of the enzymes that facilitate the conversion of OXi4503 to the form of chemical that kills tumor cells. These tumor types include hepatocellular carcinoma, melanoma, and leukemias of the myeloid lineage. In preclinical studies, OXi4503 has shown potent anti-tumor activity against solid tumors and acute myeloid leukemia models, both as a single agent and in combination with other cancer treatment modalities.
Based on the results of preclinical studies published in the journal Blood in September 2010 that show OXi4503 has potent activity against acute myelogenous leukemia (AML) in animal models, we entered into a clinical trial agreement pursuant to which investigators at the University of Florida initiated an investigator sponsored Phase 1 study of OXi4503 in patients with AML or myelodysplastic syndrome (MDS) in May 2011. This open-label, dose-escalating study for the treatment of up to 36 patients is being conducted in patients with relapsed or refractory AML and MDS and will evaluate the safety profile, maximum tolerated dose and biologic activity of OXi4503 in these patients. We expect that initial indications of biologic activity from this study may be available in the fourth quarter of 2012.
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The general direction of future development of OXi4503 for hematologic indications will depend on the outcome of the analysis of the study in AML, as well as available financial resources and potential partnering activities.
ZYBRESTAT for Ophthalmology
In addition to developing ZYBRESTAT as an intravenously administered therapy for oncology indications, we have previously undertaken an ophthalmology research and development program with ZYBRESTAT with the ultimate goal of developing a topical formulation of ZYBRESTAT for ophthalmological diseases and conditions that are characterized by abnormal blood vessel growth within the eye that result in loss of vision. Due to financial constraints, we are not actively pursuing development in this area at this time.
We believe that a safe, effective and convenient topically-administered anti-vascular therapeutic would have advantages over currently approved anti-vascular, ophthalmological therapeutics, many of which must be injected directly into patients’ eyes, in some cases on a chronic monthly basis.
We have also evaluated the requirements for additional preclinical toxicology and efficacy studies with ZYBRESTAT for topical ophthalmological formulations to better position the program for partnering. Further development of this program will depend on the outcome of our evaluation of these requirements and available financial resources.
Financial Resources
We have experienced net losses every year since our inception and, as of December 31, 2011, had an accumulated deficit of approximately $217,353,000. We expect to incur significant additional operating losses over at least the next several years, principally as a result of our continuing clinical trials and anticipated research and development expenditures. The principal source of our working capital to date has been the proceeds of private and public equity financings and to a lesser extent the exercise of warrants and stock options. We currently have no recurring material amount of licensing or other income. As of December 31, 2011, we had approximately $9,992,000 in cash, restricted cash and cash equivalents.
On July 21, 2010, we entered into an “at the market” (ATM) equity offering sales agreement with McNicoll, Lewis & Vlak LLC, (MLV), pursuant to which we may issue and sell shares of our common stock from time to time through MLV acting as our sales agent and underwriter. Sales of our common stock through MLV are made on the principal trading market of our common stock by means of ordinary brokers’ transactions at market prices, in block transactions or as otherwise agreed by MLV and us. MLV uses its commercially reasonable efforts to sell our common stock from time to time, based upon our instructions including any price, time or size limits we may impose. We pay MLV a commission rate of up to 7.0% of the gross sales price per share of any common stock sold through MLV as agent under the sales agreement. During our fiscal year 2011, we sold approximately 7,794,000 shares of our common stock using this arrangement for net proceeds of approximately $17,146,000. Currently, we are not able to sell additional shares under this ATM due to SEC limitations on the number of shares issuable pursuant to a Form S-3 registration statement in a primary offering by smaller reporting companies such as us. We expect to be able to resume such sales in the second half of 2012, should we meet the issuance criteria of the SEC and NASDAQ.
On September 1, 2011, we announced a restructuring plan, which included employee terminations, designed to focus our capital resources on our most promising early-stage clinical programs and further reduce our cash utilization. We announced the following key aspects of the restructuring and their effects on our operations including current and planned clinical trials:
| Ÿ | At this time, a Company sponsored Phase 3 registrational study of ZYBRESTAT in patients with anaplastic thyroid cancer (ATC) funded entirely by internal financial resources is not feasible. We intend to continue to explore options for conducting such a study, including potential collaborations with national and international head and neck cancer cooperative groups. Future development decisions concerning ZYBRESTAT in patients with ATC will be made following a review of all options by our management and our board of directors. |
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| Ÿ | We have concluded the final analysis of our completed Phase 2 study of ZYBRESTAT in conjunction with standard chemotherapy and bevacizumab in patients with non-small cell lung cancer (FALCON study). Any future development decisions concerning the study of ZYBRESTAT in patients with NSCLC will depend on our financial resources. |
| Ÿ | We continue to support the ongoing randomized Phase 2 trial of ZYBRESTAT in combination with bevacizumab in patients with relapsed ovarian cancer, which is an NCI-sponsored study being conducted by the Gynecologic Oncology Group (GOG), an organization dedicated to clinical research in the field of gynecologic cancer. |
| Ÿ | We continue to support of the ongoing investigator-sponsored Phase 1 trial of OXi4503 in patients with AML or myelodysplastic syndrome, or MDS, being conducted at the University of Florida and with support by The Leukemia & Lymphoma Society’s Therapy Acceleration Program. |
| Ÿ | We are evaluating additional early-stage development opportunities for our two product candidates, ZYBRESTAT and OXi4503, subject to available resources. |
| Ÿ | We reduced our workforce by 11 full-time equivalent employees or approximately 61%. As of March 9, 2012, we had a total of eight full-time employees and approximately three full-time equivalent employees working on a part-time basis. |
| Ÿ | We are seeking to reduce the amount of space we currently rent, primarily by closing our office in Waltham, Massachusetts no later than the lease expiration in May 2012 and by conducting our operations only out of our South San Francisco office as soon as practicable. |
We offered severance benefits to the terminated employees, and have recorded a total charge of approximately $1,226,000, primarily associated with personnel-related termination costs. In order to provide for an orderly transition, we implemented the reduction in work force in a phased manner. Substantially all of the charge represents cash expenditures. Upon completion of the restructuring activities outlined above, we expect to reduce expenses from fiscal 2011 levels by an annual amount of approximately $2,000,000. Our ability to achieve this anticipated cost reduction is contingent upon only continuing to conduct the projects for which we are currently committed. Based on this planned level of cash utilization, we will be unable to significantly advance our more developed candidates, including ZYBRESTAT in ATC.
In November 2011, we entered into a purchase agreement for the sale, from time to time, of up to $20,000,000 of our common stock with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor. The proceeds from any sales under this purchase agreement will be used to further develop our late and early-stage clinical pipeline and to fund our ongoing operations. During the 36-month term of the purchase agreement, we control the timing and amount of any sales to LPC, if and when we decide, in accordance with the purchase agreement. LPC has no right to require us to sell any shares to LPC, but LPC is obligated to make purchases as we direct, subject to certain conditions, which include the continuing effectiveness of a registration statement filed with the Securities and Exchange Commission covering the resale of the shares that may be issued to LPC and limitations related to the market value of our common stock. There is no guarantee that funding from LPC will be available when needed, or at all, or that the Company will be able to maintain effectiveness of the aforementioned registration statement. There are no upper limits to the price LPC may pay to purchase our common stock and the purchase price of the shares related to any future sales will be based on the prevailing market prices of our shares immediately preceding the notice of sale to LPC without any fixed discount. The agreement may be terminated by us at any time, at our sole discretion, without any cost or penalty. No amounts were received under this facility during 2011.
In December 2011, we established a partnership agreement with Azanta Danmark A/S, or Azanta, to provide access to ZYBRESTAT for the treatment of patients in a specified territory with ATC on a compassionate use basis. Our newly-formed Named Patient Program to be managed by Azanta, provides a regulatory mechanism to allow healthcare professionals in Europe and Canada to prescribe ZYBRESTAT to individual ATC patients while it is still in development. Under the terms of the agreement, we will provide ZYBRESTAT to Azanta. Azanta will serve as exclusive distributor for ZYBRESTAT in the specified territory for this purpose and will provide ZYBRESTAT to physicians solely to treat ATC on a compassionate use basis in
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the territory covered by the agreement until such time as ZYBRESTAT may obtain marketing approval in that territory. The territory includes the European Union, including the Nordic countries and Switzerland, and Canada, and the agreement may also be expanded to include other countries on a country-by-country basis. We and Azanta will cooperate on regulatory activities relating to ZYBRESTAT for the treatment of ATC within the territory. There will be no transfer of ownership of intellectual property rights for ZYBRESTAT to Azanta under the terms of the agreement. We do not expect to receive significant income from Azanta under this arrangement. No revenue was recognized nor was any cash received under this agreement during 2011.
Based on our limited ongoing programs and operations and taking into consideration the expected reductions in cash utilization resulting from our September 2011 reduction in force, we expect our existing cash and cash equivalents to support our operations through the first quarter of 2013. However, this level of cash utilization does not provide for the initiation of any significant projects to further the development of our most advanced product candidates, primarily ZYBRESTAT in ATC. Any significant further development of ZYBRESTAT or other capital intensive activities will be contingent upon our ability to raise additional capital in addition to our existing financing arrangements.
We will require significant additional funding to fund operations and to continue the development of our product candidates. Such funding may not be available to us on acceptable terms, or at all. If we are unable to access additional funds when needed, we may not be able to continue the development of our product candidates or we could be required to delay, scale back or eliminate some or all of our development programs and other operations. Any additional equity financing, which may not be available to us or may not be available on favorable terms, most likely will be dilutive to our current stockholders and debt financing, if available, may involve restrictive covenants. If we access funds through collaborative or licensing arrangements, we may be required to relinquish rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize on our own, on terms that are not favorable to us. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, will materially harm our business, financial condition and results of operations.
We are committed to a disciplined financial strategy and as such maintain a limited employee and facilities base, with development, scientific, finance and administrative functions, which include, among other things, product development, regulatory oversight and clinical testing. Our research and development team members typically work on a number of development projects concurrently. Accordingly, we do not separately track the costs for each of these research and development projects to enable separate disclosure of these costs on a project-by-project basis. We conduct scientific activities pursuant to collaborative arrangements with universities. Regulatory and clinical testing functions are generally contracted out to third-party, specialty organizations.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments, including those related to intangible assets. We base our estimates on historical experience and on various other factors that are believed to be appropriate under the circumstances, the results of which form the basis for making the judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.
While our significant accounting policies are more fully described in Note 1 to our financial statements included in this report, we believe the following accounting policies are most critical to aid in fully understanding and evaluating our reported financial results.
Use of Estimates
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period. Actual results could differ from those estimates.
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Concentration of Credit Risk
We have no significant off balance sheet concentrations of credit risk. Financial instruments that potentially subject us to concentrations of credit risk primarily consist of cash and cash equivalents. We hold our cash and cash equivalents at one financial institution.
Cash, Restricted Cash and Cash Equivalents
We consider all highly liquid financial instruments with maturities of three months or less when purchased to be cash equivalents. We have $20,000 that is used to secure financing through a Company credit card. This amount is separated from cash and cash equivalents on the Balance Sheet.
Accrued Research and Development
We charge all research and development expenses, both internal and external costs, to operations as incurred. Our research and development costs represent expenses incurred from the engagement of outside professional service organizations, product manufacturers and consultants associated with the development of our potential product candidates. We recognize expense associated with these arrangements based on the completion of activities as specified in the applicable contracts. Costs incurred under fixed fee contracts are accrued ratably over the contract period absent any knowledge that the services will be performed other than ratably. Costs incurred under contracts with clinical trial sites and principal investigators are generally accrued on a patients-treated basis consistent with the terms outlined in the contract. In determining costs incurred on some of these programs, we take into consideration a number of factors, including estimates and input provided by our internal program managers. Upon termination of such contracts, we are normally only liable for costs incurred or committed to date. As a result, accrued research and development expenses represent our estimated contractual liability to outside service providers at any of the relevant times. Any advance payments for goods or services to be used or rendered in future research and development activities pursuant to an executory contractual arrangement are properly classified as prepaid until such goods or services are rendered.
License Agreements
On August 2, 1999, we entered into an exclusive license for the commercial development, use and sale of products or services covered by certain patent rights owned by Arizona State University. The present value of the amount payable under the license agreement has been capitalized based on a discounted cash flow model and is being amortized over the term of the agreement (approximately 15.5 years). Management is required to perform an impairment analysis of its long-lived assets if triggering events occur. We review for such triggering events, including triggering events such as a going concern opinion and continuing operating losses, periodically. In addition, the agreement provides for additional payments in connection with the license arrangement upon the initiation of certain clinical trials or the completion of certain regulatory approvals, which payments could be accelerated upon the achievement of certain financial milestones as defined in the agreement. We expense these payments to research and development in the period that payment becomes both probable and estimable.
Share-based compensation
We record the expense recognition of the estimated fair value of all share-based payments issued to employees. The valuation of employee stock options is an inherently subjective process, since market values are generally not available for long-term, non-transferable employee stock options. Accordingly, an option pricing model is utilized to derive an estimated fair value. In calculating the estimated fair value of our stock options, we used the Black-Scholes option pricing model which requires the consideration of the following six variables for purposes of estimating fair value:
| Ÿ | the stock option exercise price, |
| Ÿ | the expected term of the option, |
| Ÿ | the grant date price of our common stock, which is issuable upon exercise of the option, |
| Ÿ | the expected volatility of our common stock, |
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| Ÿ | the expected dividends on our common stock (we do not anticipate paying dividends in the foreseeable future), and |
| Ÿ | the risk free interest rate for the expected option term. |
Stock Option Exercise Price and Grant Date Price of our common stock — The closing market price of our common stock on the date of grant.
Expected Term — The expected term of options represents the period of time for which the options are expected to be outstanding and is based on an analysis of historical behavior of participants over time.
Expected Volatility — The expected volatility is a measure of the amount by which our stock price is expected to fluctuate during the term of the option granted. We determine the expected volatility based on the historical volatility of our common stock over a period commensurate with the option’s expected term.
Expected Dividends — Because we have never declared or paid any cash dividends on any of our common stock and do not expect to do so in the foreseeable future, we use an expected dividend yield of zero to calculate the grant date fair value of a stock option.
Risk-Free Interest Rate — The risk-free interest rate is the implied yield available on U.S. Treasury issues with a remaining life consistent with the option’s expected term on the date of grant.
Of the variables above, the selection of an expected term and expected stock price volatility are the most subjective.
We are required to estimate the level of award forfeitures expected to occur and record compensation expense only for those awards that are ultimately expected to vest. Accordingly, we perform a historical analysis of option awards that are forfeited prior to vesting, and record total stock option expense that reflects this estimated forfeiture rate. We segregate participants into two distinct groups, (1) directors and officers and (2) employees, and apply the estimated forfeiture rates using the Straight Line (Uniform) method to record expense. This analysis is re-evaluated quarterly and the forfeiture rate adjusted as necessary.
Symphony Transaction
In October 2008, we announced a strategic collaboration with Symphony Capital Partners, L.P. (Symphony), a private-equity firm, under which Symphony agreed to provide up to $40,000,000 in funding to support the advancement of ZYBRESTAT for oncology, ZYBRESTAT for ophthalmology and OXi4503. In connection with the collaboration, we granted Symphony ViDA, Inc., a newly-created drug development company, exclusive licenses to ZYBRESTAT for use in ophthalmologic indications and OXi4503.
Under the collaboration, we entered into a series of related agreements with Symphony Capital LLC, Symphony ViDA, Symphony ViDA Holdings LLC (Holdings) and related entities, including a Purchase Option Agreement, a Research and Development Agreement, a Technology License Agreement and an Additional Funding Agreement. In addition, we entered into a series of related agreements with Holdings, including a Stock and Warrant Purchase Agreement and a Registration Rights Agreement.
Pursuant to these agreements, Holdings formed and capitalized Symphony ViDA in order (a) to hold certain intellectual property related to the programs which were exclusively licensed to Symphony ViDA under the Technology License Agreement and (b) to fund commitments of up to $25,000,000. The funding was intended to support preclinical and clinical development by us, on behalf of Symphony ViDA, of the programs.
We issued to Holdings, pursuant to the Stock and Warrant Purchase Agreement, an aggregate of 675,675 shares of our common stock and warrants at a price of $22.20 per share, which was the closing price of our common stock on September 30, 2008, the day before we entered into the Symphony transaction. In addition, pursuant to the Purchase Option Agreement, we issued to Holdings an aggregate of 180,180 shares of our common stock with a fair value of $4,000,000 as consideration for the Purchase Option.
On July 2, 2009, we, Holdings and Symphony ViDA entered into a series of related agreements pursuant to which we exercised the Purchase Option under terms set forth in an amended and restated purchase option agreement (the Amended Purchase Option Agreement), and we and Holdings also entered into an amended and restated registration rights agreement.
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We closed on the amended Purchase Option on July 20, 2009 and issued 500,000 shares of our common stock to Holdings at the closing in exchange for all of the equity of Symphony ViDA. In addition, upon the closing of the Purchase Option, we re-acquired all of the rights to the programs, and the approximately $12,400,000 in cash held by Symphony ViDA at the time of the closing became available for use for general corporate purposes.
Consolidation of Variable Interest Entity (VIE)
A variable interest entity (VIE) is (1) an entity that has equity that is insufficient to permit the entity to finance its activities without additional subordinated financial support, or (2) an entity that has equity investors that cannot make significant decisions about the entity’s operations or that do not absorb their proportionate share of the expected losses or do not receive the expected residual returns of the entity. A VIE should be consolidated by the party that is deemed to be the primary beneficiary, which is the party that has exposure to a majority of the potential variability in the VIE’s outcomes. The application of accounting policy to a given arrangement requires significant management judgment.
We consolidated the financial position and results of operations of Symphony ViDA, Inc. (“ViDA”) from October 2008, when it entered into a strategic collaboration with Symphony ViDA Holdings, LLC (“Symphony”), until July 20, 2009 when we acquired 100% of ViDA pursuant to the Amended Purchase Option Agreement. We believe ViDA was by design a VIE because we had a purchase option to acquire its outstanding voting stock at prices that are fixed based upon the date the option is exercised. The fixed nature of the purchase option price limited Symphony ViDA Holding’s returns, as the investor in ViDA. Further, due to the direct investment from Holdings in our common stock, as a related party ViDA was a VIE of which we were the primary beneficiary. After we exercised the purchase option, ViDA became a wholly-owned subsidiary of ours and ceased being a VIE.
Accounting and Reporting of Noncontrolling Interests
On January 1, 2009, we adopted (retrospectively for all periods presented) the new presentation requirements for noncontrolling interests required by ASC 810, Consolidations. Under ASC 810, earnings or losses attributed to the noncontrolling interests are reported as part of consolidated earnings and not as a separate component of income or expense. Accordingly, we reported the consolidated earnings of ViDA in its consolidated statement of operations from October 2008, when we entered into a strategic collaboration with Symphony, until July 20, 2009, when we acquired 100% of the equity of ViDA pursuant to the Amended Purchase Option Agreement. Once becoming our wholly-owned subsidiary, the operating results of ViDA continued to be included in our consolidated statement of operations but were no longer subject to the presentation requirements applicable to noncontrolling interests. Losses incurred by ViDA, and attributable to Symphony, were charged to noncontrolling interest.
Accounting for Derivative Financial Instruments Indexed to and Potentially Settled in the Company’s Common stock
We evaluate all derivative financial instruments issued in connection with our equity offerings when determining the proper accounting treatment for such instruments in the Company’s financial statements. The Company considers a number of generally accepted accounting principles to determine such treatment. The Company performs a number of steps to evaluate the features of the instrument against the guidance provided in the accounting pronouncements in order to determine the appropriate accounting treatment. The Company’s policy with regard to settling outstanding financial instruments is to settle those with the earliest maturity date first which essentially sets the order of preference for settling the awards. In the majority of circumstances, we utilize the Black Scholes method to determine the fair value of our derivative financial instruments. In some cases, where appropriate, we utilize the Binomial method to determine the fair value of such derivative financial instruments. Key valuation factors in determining the fair value include the current stock price as of the date of measurement, the exercise price, the remaining contractual life, expected volatility for the instrument and the risk-free interest rate. Changes in fair value are recorded as a gain or loss in our Statement of Operations with the corresponding amount recorded as an adjustment to the liability on our Balance Sheet. The expected volatility factor, in particular, is subject to significant variability from measurement period to measurement period and can result in large gains or losses from period to period.
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Revenue Recognition
In December 2011, we established a partnership agreement with Azanta Danmark A/S, or Azanta, to provide access to ZYBRESTAT for the treatment of patients in a specified territory with ATC on a compassionate use basis. Our newly-formed Named Patient Program to be managed by Azanta, provides a regulatory mechanism to allow healthcare professionals in Europe and Canada to prescribe ZYBRESTAT to individual ATC patients while it is still in development. Our agreement with Azanta provides that upon the receipt of ZYBRESTAT by Azanta for distribution and sale to compassionate use patients, Azanta has 30 days to inspect the product for defects and to ensure that the product conforms to the warranties made by us. If Azanta does not notify us of any defective product within the 30-day period it will be deemed to have accepted the product. Revenue is recognized based on product accepted at the conclusion of the 30-day inspection period. Also, Azanta will pay to us, on a quarterly basis, an amount equal to 20% of Azanta’s gross margin, as defined in the agreement, on its sales in the preceding quarter. This revenue will be recognized upon notification from Azanta of the gross margin earned.
In addition, we licensed to a third party our formerly owned Nicoplex and Thiol Test technology. Revenue in connection with this license arrangement is earned based on sales of products or services utilizing this technology. Revenue is recognized under this agreement when payments are received due to the uncertainty of the timing of sales of products or services.
Years ended December 31, 2011 and 2010
Revenues
We did not recognize any license revenue in the years ended December 31, 2011 and 2010. Future revenues, if any, from license agreements are expected to be minimal. In addition, we did not recognize any product revenue in the fiscal year ended December 31, 2011 in connection with our distribution agreement with Azanta as no product had been accepted by Azanta as of December 31, 2011.
Our future revenues will depend upon our ability to establish collaborations with respect to, and generate revenues from products currently under development by us. We expect that we will not generate meaningful revenue unless and until we enter into new collaborations providing for funding through the payment of licensing fees and up-front payments.
Costs and Expenses
The following table summarizes our operating expenses for the periods indicated, in thousands and as a percentage of total expenses:
| Twelve Months ended December 31, | ||||||||||||||||||||||||
| 2011 | 2010 | Increase (Decrease) | ||||||||||||||||||||||
| % of Total Operating | % of Total Operating | |||||||||||||||||||||||
| Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Research and development | $ | 5,291 | 45 | % | $ | 12,114 | 65 | % | $ | (6,823 | ) | -56 | % | |||||||||||
General and administrative | 5,375 | 45 | % | 5,885 | 32 | % | (510 | ) | -9 | % | ||||||||||||||
Restructuring | 1,226 | 10 | % | 510 | 3 | % | 716 | 140 | % | |||||||||||||||
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Total operating expenses | $ | 11,892 | 100 | % | $ | 18,509 | 100 | % | $ | (6,617 | ) | -36 | % | |||||||||||
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Research and development expenses
The table below summarizes the most significant components of our research and development expenses for the periods indicated, in thousands and as a percentage of total research and development expenses and provides the changes in these components and their percentages:
| Twelve Months ended December 31, | ||||||||||||||||||||||||
| 2011 | 2010 | Increase (Decrease) | ||||||||||||||||||||||
| % of Total | % of Total | |||||||||||||||||||||||
| Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
External services | $ | 2,519 | 48 | % | $ | 7,944 | 65 | % | $ | (5,425 | ) | -68 | % | |||||||||||
Employee compensation and related | 1,965 | 37 | % | 3,247 | 27 | % | (1,282 | ) | -39 | % | ||||||||||||||
Employee Stock-based compensation | 301 | 5 | % | 241 | 2 | % | 60 | 25 | % | |||||||||||||||
Other | 506 | 10 | % | 682 | 6 | % | (176 | ) | -26 | % | ||||||||||||||
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Total research and development | $ | 5,291 | 100 | % | $ | 12,114 | 100 | % | $ | (6,823 | ) | -56 | % | |||||||||||
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The reduction in external services expenses for the fiscal year ended December 31, 2011 compared to the same twelve month period in 2010 is primarily attributable to a reduction in spending on all of our clinical projects for the comparable periods with the majority of the reduction coming from our ZYBRESTAT for oncology program, most prominently our anaplastic thyroid cancer and non-small cell lung cancer projects. These two major studies have been progressing to conclusion over the last 12 to 18 months. In addition, we experienced reductions in expenses on our OXi4503 and ZYBRESTAT for ophthalmology programs for the comparable 2011 period, primarily related to our decision in February 2010 to scale back efforts on some of our projects in these areas.
The reduction in employee compensation and related expenses for the twelve month period ended December 31, 2011 compared to the same twelve month period of 2010 is due to reductions in our clinical project expenses noted above. In February 2010 and again in September 2011, we implemented a Company wide restructuring plan due to our decision to scale back activities in some of our ongoing clinical projects.
The reduction in other expenses for the twelve month period ended December 31, 2011 compared to the same twelve month period of 2010 is primarily due to a reduction in both our research and development facility related costs as well as program wide support costs for the comparable periods.
General and administrative expenses
The table below summarizes the most significant components of our general and administrative expenses for the periods indicated, in thousands and as a percentage of total general and administrative expenses and provides the changes in these components and their percentages:
| Twelve Months ended December 31, | ||||||||||||||||||||||||
| 2011 |
| 2010 |
| Increase (Decrease) | ||||||||||||||||||||
| % of Total | % of Total | |||||||||||||||||||||||
| Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Employee compensation and related | $ | 1,788 | 33 | % | $ | 2,049 | 35 | % | $ | (261 | ) | -13 | % | |||||||||||
Employee Stock-based compensation | 441 | 8 | % | 453 | 8 | % | (12 | ) | -3 | % | ||||||||||||||
Consulting and professional services | 1,976 | 37 | % | 2,295 | 39 | % | (319 | ) | -14 | % | ||||||||||||||
Other | 1,170 | 22 | % | 1,088 | 18 | % | 82 | 8 | % | |||||||||||||||
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Total general and administrative | $ | 5,375 | 100 | % | $ | 5,885 | 100 | % | $ | (510 | ) | -9 | % | |||||||||||
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The reduction in employee compensation and related expenses for the twelve month period ended December 31, 2011 compared to the same twelve month period of 2010 is due to a reduction in our average full time equivalents for the comparable periods. In February 2010 and again in September 2011, we implemented a Company wide restructuring plan due to our decision to scale back activities in some of our ongoing clinical projects.
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The reduction in consulting and professional services expenses for the twelve month period ended December 31, 2011 compared to the same twelve month period of 2010 is primarily due to one time costs incurred in 2010 in connection with both our attempt to acquire Vaxgen Inc. and to a PIPE financing transaction that did not recur in the 2011 period. In addition, we experienced lower board member compensation expense attributable to lower stock valuations during the first half of the 2011 period as a portion of fees to board members are paid in the form of non-cash stock awards. Also, we recognized lower legal, accounting and service provider expenses due to fewer significant transactions during the 2011 period.
Restructuring Plan
On September 1, 2011, we announced a restructuring plan, which included employee terminations, designed to focus our capital resources on our most promising early-stage clinical programs and further reduce our cash utilization. We announced the following key aspects of the restructuring and their effects on our operations including current and planned clinical trials:
| Ÿ | At this time, a Company sponsored Phase 3 registrational study of ZYBRESTAT in patients with anaplastic thyroid cancer (ATC) funded entirely by internal financial resources is not feasible. We intend to continue to explore options for conducting such a study, including obtaining financing from external sources as well as potential collaborations with national and international head and neck cancer cooperative groups. Future development decisions concerning ZYBRESTAT in patients with ATC will be made following a review of all options by our management and our board of directors. |
| Ÿ | We have concluded the final analysis of our completed Phase 2 study of ZYBRESTAT in conjunction with standard chemotherapy and bevacizumab in patients with non-small cell lung cancer (FALCON study). Any future development decisions concerning the study of ZYBRESTAT in patients with NSCLC will depend on our financial resources. |
| Ÿ | We continue to support the ongoing randomized Phase 2 trial of ZYBRESTAT in combination with bevacizumab in patients with relapsed ovarian cancer, which is an NCI-sponsored study being conducted by the Gynecologic Oncology Group (GOG), an organization dedicated to clinical research in the field of gynecologic cancer. |
| Ÿ | We continue to support of the ongoing investigator-sponsored Phase 1 trial of OXi4503 in patients with AML or myelodysplastic syndrome, or MDS, being conducted at the University of Florida and with support by The Leukemia & Lymphoma Society’s Therapy Acceleration Program. |
| Ÿ | We are evaluating additional early-stage development opportunities for our two product candidates, ZYBRESTAT and OXi4503, subject to available resources at the time. |
| Ÿ | We reduced our workforce by 11 full-time equivalent employees or approximately 61%. As of March 9, 2012, we had a total of eight full-time employees and approximately three full-time equivalent employees working on a part-time basis. |
| Ÿ | We are seeking to reduce the amount of space we currently rent, primarily by closing our office in Waltham, Massachusetts no later than the lease expiration in May 2012 and by conducting our operations only out of our South San Francisco office as soon as practicable. |
We offered severance benefits to the terminated employees, and have recorded a total charge of approximately $1,226,000, primarily associated with personnel-related termination costs. In order to provide for an orderly transition, we implemented the reduction in work force in a phased manner. Substantially all of the charge represents cash expenditures. Upon completion of the restructuring activities outlined above, we expect to reduce expenses from fiscal 2011 levels by an annual amount of approximately $2,000,000. Our ability to achieve this anticipated cost reduction is contingent upon only continuing to conduct the projects for which we are currently committed.
On February 11, 2010, we announced a restructuring plan designed to focus resources on our highest-value clinical assets and reduce our cash utilization. Key aspects of the 2010 restructuring were as follows:
| Ÿ | We continued to advance our high-priority Phase 2 ZYBRESTAT trial in non-small cell lung cancer (FALCON study), with a focus on the presentation of updated safety and efficacy results anticipated for presentation at the American Society of Clinical Oncology (ASCO) meeting in June 2011. |
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| Ÿ | We stopped further enrollment in the Phase 2/3 FACT clinical trial in anaplastic thyroid cancer (ATC), but continued to treat and follow all patients who enrolled in the study. |
| Ÿ | We discontinued enrolling patients in our OXi4503 Phase 1b trial in patients with hepatic tumors. |
| Ÿ | We discontinued enrollment in our Phase 2 FAVOR study of ZYBRESTAT in polypoidal choroidal vasculopathy (PCV), a form of macular degeneration. |
| Ÿ | In addition, we reduced our workforce by 20 employees or approximately 49%. |
Other Income and Expenses
The table below summarizes Other Income and Expense in our Income Statement for the years 2011 and 2010, in thousands.
| Years ended December 31, | Increase (Decrease) | |||||||||||||||
| 2011 | 2010 | Amount | % | |||||||||||||
Change in fair value of warrants and other financial instruments | $ | 2,222 | $ | (6,018 | ) | $ | 8,240 | -137 | % | |||||||
Investment income | 7 | 17 | (10 | ) | -59 | % | ||||||||||
Other income, net | 10 | 740 | (730 | ) | -99 | % | ||||||||||
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Total | $ | 2,239 | $ | (5,261 | ) | $ | 7,500 | -143 | % | |||||||
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We recorded a non-cash gain in the 2011 twelve month period and a non-cash loss in the 2010 twelve month period as a result of changes in the estimated Fair Market Value of our common stock warrants issued in connection with the offerings as discussed in the Warrants section of Note 6 to the financial statements.
The Other income amounts are generally derived from net gains on foreign currency exchange. Also included in the fiscal 2010 amount is our receipt of $733,000 in connection with qualified investments in a qualifying therapeutic discovery project under section 48D of the Internal Revenue Code in November 2010.
The table below summarizes the components of the change in fair value of warrants for the twelve month periods ended December 31, 2011 and December 31, 2010, in thousands.
| Twelve months ended December 31, | ||||||||
| 2011 | 2010 | |||||||
Committed Equity Financing Facility Warrants | $ | 3 | $ | 96 | ||||
Direct Registration Warrants | 102 | 2,093 | ||||||
Excess of value of the Private Placement Warrants at issuance over the net proceeds of the offering | — | (4,933 | ) | |||||
Gain recognized in connection with warrant exchange agreements | 690 | — | ||||||
Private Placement Warrants | 1,427 | (3,274 | ) | |||||
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Total gain (loss) on change in fair market value of derivatives | $ | 2,222 | $ | (6,018 | ) | |||
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Tax Matters
At December 31, 2011, the Company had a net operating loss carry-forward of approximately $71,405,000 for U.S. income tax purposes, which began to expire for U.S. purposes during 2011. Due to the degree of uncertainty related to the ultimate use of these loss carry-forwards, we have fully reserved this future benefit. Additionally, the future utilization of the U.S. net operating loss carry-forwards is subject to limitations under the change in stock ownership rules of the Internal Revenue Service. The valuation allowance decreased by approximately $2,854,000 and increased by approximately $5,640,000 for the years ended December 31, 2011 and 2010, respectively, due primarily to changes in net operating loss carry-forwards.
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Years ended December 31, 2010 and 2009
Revenues
We did not recognize any license revenue in the years ended December 31, 2010 and 2009, in connection with the license of our nutritional and diagnostic technology or otherwise. Future revenues, if any, from this license agreement are expected to be minimal.
Our future revenues will depend upon our ability to establish collaborations with respect to, and generate revenues from products currently under development by us. We expect that we will not generate meaningful revenue unless and until we enter into new collaborations providing for funding through the payment of licensing fees and up-front payments.
Costs and Expenses
The following table summarizes our operating expenses for the periods indicated, in thousands and as a percentage of total expenses:
| 2010 | 2009 | Increase (Decrease) | ||||||||||||||||||||||
| % of Total Operating | % of Total Operating | |||||||||||||||||||||||
| Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Research and development | $ | 12,114 | 65 | % | $ | 22,256 | 71 | % | $ | (10,142 | ) | -46 | % | |||||||||||
General and administrative | 5,885 | 32 | % | 8,900 | 29 | % | (3,015 | ) | -34 | % | ||||||||||||||
Restructuring | 510 | 3 | % | — | 510 | N/A | ||||||||||||||||||
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Total operating expenses | $ | 18,509 | 100 | % | $ | 31,156 | 100 | % | $ | (12,647 | ) | -41 | % | |||||||||||
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Research and development expenses
The table below summarizes the most significant components of our research and development expenses for the periods indicated, in thousands and as a percentage of total research and development expenses and provides the changes in these components and their percentages:
| 2010 | 2009 | Increase (Decrease) | ||||||||||||||||||||||
| % of Total | % of Total | |||||||||||||||||||||||
| Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
External services | $ | 7,944 | 66 | % | $ | 13,233 | 59 | % | $ | (5,289 | ) | -40 | % | |||||||||||
Employee compensation and related | 3,247 | 27 | % | 7,692 | 35 | % | (4,445 | ) | -58 | % | ||||||||||||||
Stock-based compensation | 241 | 1 | % | 184 | 1 | % | 57 | 31 | % | |||||||||||||||
Other | 682 | 6 | % | 1,147 | 5 | % | (465 | ) | -41 | % | ||||||||||||||
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Total research and development | $ | 12,114 | 100 | % | $ | 22,256 | 100 | % | $ | (10,142 | ) | -46 | % | |||||||||||
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The reduction in external services expenses for the year ended December 31, 2010 compared to the same twelve month period in 2009 is primarily attributable to a reduction in spending on our ZYBRESTAT for Oncology program of approximately $3,300,000. This reduction is primarily attributable to lower costs on our ATC study for the comparable 2010 period in connection with our decision to discontinue further recruitment of patients on this study in February 2010. In addition, we experienced reductions in expenses on both our OXi4503 and ZYBRESTAT for Ophthalmology programs for the comparable 2010 period, primarily related to our decision in February 2010 to scale back efforts in some of our projects in these areas as well.
The reduction in employee compensation and related expenses for the year ended December 31, 2010 compared to the same twelve month period of 2009 is due to a 50% reduction in our average full time equivalents for the comparable 2010 period. In February 2010 we implemented a Company-wide restructuring plan due to our decision to scale back activities in some of our ongoing clinical projects.
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The reduction in other expenses for the year ended December 31, 2010 compared to the same twelve month period of 2009 is primarily due to a reduction in both our research and development facility related costs as well as program wide support costs for the comparable 2010 period.
General and administrative expenses
The table below summarizes the most significant components of our general and administrative expenses for the periods indicated, in thousands and as a percentage of total general and administrative expenses and provides the changes in these components and their percentages:
| 2010 | 2009 | Increase (Decrease) | ||||||||||||||||||||||
| % of Total | % of Total | |||||||||||||||||||||||
| Amount | Expenses | Amount | Expenses | Amount | % | |||||||||||||||||||
Employee compensation and related | $ | 2,049 | 35 | % | $ | 3,165 | 36 | % | $ | (1,116 | ) | -35 | % | |||||||||||
Stock-based compensation | 453 | 8 | % | 272 | 3 | % | $ | 181 | 67 | % | ||||||||||||||
Consulting and professional services | 2,295 | 39 | % | 4,409 | 50 | % | $ | (2,114 | ) | -48 | % | |||||||||||||
Other | 1,088 | 18 | % | 1,054 | 11 | % | $ | 34 | 3 | % | ||||||||||||||
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Total general and administrative | $ | 5,885 | 100 | % | $ | 8,900 | 100 | % | $ | (3,015 | ) | -34 | % | |||||||||||
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The reduction in employee compensation and related expenses for the year ended December 31, 2010 compared to the same twelve month period of 2009 is due to a reduction in both our average full time equivalents of 16% and expenses in the 2009 period for administrative costs associated with the Symphony ViDA entity that did not recur in the 2010 period. In February 2010, we implemented a Company-wide restructuring plan due to our decision to scale back activities in some of our ongoing clinical projects. The number and scope of our clinical development projects affects how we staff and support those projects.
The increase in stock based compensation expense for the year ended December 31, 2010 compared to the same twelve month period of 2009 is due to timing and vesting periods of option awards to employees.
The reduction in consulting and professional services expenses for the year ended December 31, 2010 compared to the same twelve month period of 2009 is primarily due to a reduction in both recurring professional services fees including director and audit fees for the comparable periods as well as one time costs incurred in the 2009 period for corporate wide quality systems reviews and costs incurred in our attempt to acquire VaxGen Inc. that did not recur in the 2010 period.
Restructuring Plan
On February 11, 2010, we announced a restructuring plan designed to focus resources on our highest-value clinical assets and reduce our cash utilization. Key aspects of the restructuring were as follows:
| Ÿ | We continued to advance our high-priority Phase 2 ZYBRESTAT trial in non-small cell lung cancer (FALCON study), with a focus on the presentation of updated safety and efficacy results anticipated for presentation at the American Society of Clinical Oncology (ASCO) meeting in June 2011. |
| Ÿ | We stopped further enrollment in the Phase 2/3 FACT clinical trial in anaplastic thyroid cancer (ATC), but continued to treat and follow all patients who enrolled in the study. |
| Ÿ | We discontinued enrolling patients in our OXi4503 Phase 1b trial in patients with hepatic tumors. |
| Ÿ | We discontinued enrollment in our Phase 2 FAVOR study of ZYBRESTAT in polypoidal choroidal vasculopathy (PCV), a form of macular degeneration. |
| Ÿ | In addition, we reduced our workforce by 20 employees or approximately 49%. |
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Other Income and Expenses
The table below summarizes Other Income and Expense in our Income Statement for the years 2010 and 2009, in thousands.
| Increase (Decrease) | ||||||||||||||||
| 2010 | 2009 | Amount | % | |||||||||||||
Change in fair value of warrants and other financial instruments | $ | (6,018 | ) | $ | 2,166 | $ | (8,184 | ) | -378 | % | ||||||
Investment income | 17 | 110 | (93 | ) | -85 | % | ||||||||||
Other income (expense), net | 740 | (63 | ) | 803 | 1275 | % | ||||||||||
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Total | $ | (5,261 | ) | $ | 2,213 | $ | (7,474 | ) | -338 | % | ||||||
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We record non-cash gain/(loss) as a result of a change in the estimated Fair Market Value (“FMV”) of our Derivative Liabilities and the common stock warrants issued in connection with our equity offerings as discussed inAccounting for Derivative Financial Instruments Indexed to and Potentially Settled in the Company’s Common stock, Note 1 to our financial statements, Summary of Significant Accounting Policies. In 2010, the loss primarily relates to the triggering of the full-ratchet provisions of the PIPE warrants, where the exercise price of each warrant was decreased, causing a greater warrant liability. In 2009, the gain primarily relates to the decline in the underlying fair value of the common stock.
The decrease in Investment income of $93,000 for fiscal 2010 compared to fiscal 2009 is primarily a result of a reduction in our average month end cash balance available for investment during the respective periods.
The Other income (expense) amounts are derived from our gain and loss on foreign currency exchange and reflect both a change in number of foreign clinical trials and the fluctuation in exchange rates. Also included in the fiscal 2010 amount is our receipt of $733,000 in connection with qualified investments in a qualifying therapeutic discovery project under section 48D of the Internal Revenue Code in November 2010.
LIQUIDITY AND CAPITAL RESOURCES
To date, we have financed our operations principally through net proceeds received from private and public equity financings and through our strategic development arrangement with Symphony, which concluded in 2009. We have experienced negative cash flow from operations each year since our inception, except in fiscal 2000. As of December 31, 2011, we had an accumulated deficit of approximately $217,353,000. We expect to continue to incur increased expenses, resulting in losses, over at least the next several years due to, among other factors, our continuing and planned clinical trials and anticipated research and development activities. We had cash, cash equivalents and restricted cash of approximately $9,992,000 at December 31, 2011.
The following table summarizes our cash flow activities for the periods indicated, in thousands:
| Years ended December 31, | ||||||||
| 2011 | 2010 | |||||||
Operating activities: | ||||||||
Net loss | $ | (9,653 | ) | $ | (23,770 | ) | ||
Non-cash adjustments to net loss | (1,221 | ) | 7,164 | |||||
Changes in operating assets and liabilities | (910 | ) | (3,821 | ) | ||||
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Net cash used in operating activities | (11,784 | ) | (20,427 | ) | ||||
Investing activities: | ||||||||
Change in other assets | — | 3 | ||||||
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Net cash provided by investing activities | — | 3 | ||||||
Financing activities: | ||||||||
Proceeds from issuance of common stock | 17,154 | 11,094 | ||||||
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Net cash provided by financing activities | 17,154 | 11,094 | ||||||
Increase (decrease) in cash and cash equivalents | 5,370 | (9,330 | ) | |||||
Cash and cash equivalents at beginning of period | 4,602 | 13,932 | ||||||
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Cash and cash equivalents at end of period | $ | 9,972 | $ | 4,602 | ||||
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Non-cash adjustments to net loss in the year ended December 31, 2011 consist primarily of a gain from a change in the fair value of warrants and other financial instruments of $2,222,000, offset by stock-based compensation expense of $851,000 primarily related to the issuance of options to purchase our common stock. The net change in operating assets and liabilities is primarily attributable to a decrease in accounts payable, accrued expenses and other payables of $956,000, offset in part by a decrease in restricted cash of $55,000. Net cash provided by financing activities for the year ended December 31, 2011 is primarily attributable to the net proceeds of the sale of common stock under our “at the market” equity financing facility discussed below.
On January 18, 2011, we entered into separate Warrant Exchange Agreements with each of the holders of warrants to purchase shares of our common stock issued in March 2010, pursuant to which, at the initial closing, the warrant holders exchanged their outstanding Series A and Series C warrants having “ratchet” price-based anti-dilution protections for (A) an aggregate of 1,096,933 shares of common stock and (B) Series E Warrants to purchase an aggregate of 1,222,623 shares of common stock. The Series E Warrants were not exercisable for six months, had an exercise price of $4.60 per share (reflecting the market value of the shares of common stock as of the close of trading on January 18, 2011, prior to the entry into the Warrant Exchange Agreements), and do not contain any price-based anti-dilution protections. In addition, we agreed to seek shareholder approval to issue up to 457,544 additional shares of common stock to the warrant holders in a subsequent closing. Such shareholder approval was obtained on March 18, 2011, and the Series E Warrants issued at the initial closing were exchanged for the additional 457,544 shares of common stock.
On July 21, 2010, we entered into an “at the market” (ATM) equity offering sales agreement with McNicoll, Lewis & Vlak LLC, (MLV), pursuant to which we may issue and sell shares of our common stock from time to time through MLV acting as our sales agent and underwriter. Sales of our common stock through MLV, are made on the principal trading market of our common stock by means of ordinary brokers’ transactions at market prices, in block transactions or as otherwise agreed by MLV and us. MLV uses its commercially reasonable efforts to sell our common stock from time to time, based upon our instructions (including any price, time or size limits we may impose). We pay MLV a commission rate of up to 7.0% of the gross sales price per share of any common stock sold through MLV as agent under the sales agreement. During our fiscal year 2011, we sold approximately 7,794,000 shares of our common stock for net proceeds of approximately $17,146,000. Currently, we are not able to sell additional shares under this ATM due to SEC limitations on the number of shares issuable pursuant to a Form S-3 registration statement in a primary offering by smaller reporting companies such as us. We expect to be able to resume such sales in the second half of 2012, should we meet the issuance criteria of the SEC and NASDAQ.
On September 1, 2011, we announced a restructuring plan, which included employee terminations, designed to focus our capital resources on our most promising early-stage clinical programs and further reduce our cash utilization. We offered severance benefits to the terminated employees, and have recorded a total charge of approximately $1,226,000, primarily associated with personnel-related termination costs. In order to provide for an orderly transition, we implemented the reduction in work force in a phased manner. Substantially all of the charge represents cash expenditures. Upon completion of the restructuring activities outlined above, we expect to reduce expenses from fiscal 2011 levels by an annual amount of approximately $2,000,000. Our ability to achieve this anticipated cost reduction is contingent upon only continuing to conduct the projects for which we are currently committed. Based on this planned level of cash utilization, we will be unable to advance our more developed candidates, including ZYBRESTAT in ATC.
In November 2011, we entered into a purchase agreement for the sale, from time to time, of up to $20,000,000 of our common stock with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor. The proceeds from any sales under this purchase agreement will be used to further develop our late and early-stage clinical pipeline and to fund our ongoing operations. During the 36-month term of the purchase agreement, we control the timing and amount of any sales to LPC, if and when we decide, in accordance with the purchase agreement. LPC has no right to require us to sell any shares to LPC, but LPC is obligated to make purchases as we direct, subject to certain conditions, which include the continuing effectiveness of a registration statement filed with the Securities and Exchange Commission covering the resale of the shares that may be issued to LPC and limitations related to the market value of our common stock. There is no guarantee that funding from LPC will be available when needed, or at all. . There are no upper limits to the price LPC may pay
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to purchase the Company’s common stock and the purchase price of the shares related to any future sales will be based on the prevailing market prices of the Company’s shares immediately preceding the notice of sale to LPC without any fixed discount. The agreement may be terminated by us at any time, at our sole discretion, without any cost or penalty. No amounts were received under this facility during 2011.
In December 2011, we established a partnership agreement with Azanta Danmark A/S, or Azanta, to provide access to ZYBRESTAT for the treatment of patients in a specified territory with ATC on a compassionate use basis. Our newly-formed Named Patient Program to be managed by Azanta provides a regulatory mechanism to allow healthcare professionals in the territory to prescribe ZYBRESTAT to individual ATC patients while it is still in development. Under the terms of the agreement, we will provide ZYBRESTAT to Azanta. Azanta will serve as exclusive distributor for ZYBRESTAT in the specified territory for this purpose and will provide ZYBRESTAT to physicians solely to treat ATC on a compassionate use basis in the territory covered by the agreement until such time as ZYBRESTAT may obtain marketing approval in that territory. The territory includes the European Union, including the Nordic countries and Switzerland, and Canada, and the agreement may also be expanded to include other countries on a country-by-country basis. OXiGENE and Azanta will cooperate on regulatory activities relating to ZYBRESTAT for the treatment of ATC within the territory. There will be no transfer of ownership of intellectual property rights for ZYBRESTAT to Azanta under the terms of the agreement. We do not expect to receive significant income from Azanta under this arrangement. No revenue was recognized nor was any cash received under this agreement during 2011.
Based on our limited ongoing programs and operations and taking into consideration the expected reductions in cash utilization resulting from our September 2011 reduction in force, we expect our existing cash and cash equivalents to support our operations through the first quarter of 2013. However, this level of cash utilization does not provide for the initiation of any significant projects to further the development of our most advanced product candidates, primarily ZYBRESTAT in ATC. Any significant further development of ZYBRESTAT or other capital intensive activities will be contingent upon our ability to raise additional capital in addition to our existing financing arrangements
We will require significant additional funding to fund operations and to continue the development of our product candidates. Our ongoing capital requirements will depend on numerous factors, including: the progress and results of preclinical testing and clinical trials of our product candidates under development, including ZYBRESTAT and OXi4503; the costs of complying with FDA and other regulatory agency requirements, including addressing the findings set forth by the FDA in its correspondence to us in March 2012, which will be significant – as described in the Risk Factors above regarding the conduct of clinical trials and regulatory requirements; the progress of our research and development programs; the time and costs expended and required to obtain any necessary or desired regulatory approvals; the resources, if any, that we devote to develop manufacturing methods and advanced technologies; our ability to enter into licensing arrangements, including any unanticipated licensing arrangements that may be necessary to enable us to continue our development and clinical trial programs; the costs and expenses of filing, prosecuting and, if necessary, enforcing our patent claims, or defending against possible claims of infringement by third-party patent or other technology rights; the cost of commercialization activities and arrangements, if any, undertaken by us; and, if and when approved, the demand for our products, which demand depends in turn on circumstances and uncertainties that cannot be fully known, understood or quantified unless and until the time of approval, including the range of indications for which any product is granted approval.
If we are unable to raise additional funds when needed, we will not be able to continue development of our product candidates or we will be required to delay, scale back or eliminate some or all of our development programs or cease operations. We may seek to raise additional funds through public or private financing, strategic partnerships or other arrangements. Any additional equity financing may be dilutive to our current stockholders and debt financing, if available, may involve restrictive covenants. If we raise funds through collaborative or licensing arrangements, we may be required to relinquish, on terms that are not favorable to us, rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize. Our failure to raise capital when needed will materially harm our business, financial condition and results of operations.
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Contractual Obligations
The following table presents information regarding our contractual obligations and commercial commitments as of December 31, 2011 in thousands:
| Total | Less than 1 year | 1-3 years | 4-5 years | After 5 years | ||||||||||||||||
Clinical development and related commitment | $ | 515 | $ | 412 | $ | 103 | $ | — | $ | — | ||||||||||
Operating Leases | 684 | 549 | 135 | — | — | |||||||||||||||
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Total contractual cash obligations | $ | 1,199 | $ | 961 | $ | 238 | $ | — | $ | — | ||||||||||
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Payments under clinical development and related commitments are based on the completion of activities as specified in the contract. The amounts in the table above assume the successful completion, by the third-party contractor, of all of the activities contemplated in the agreements.
Our primary drug development programs are based on a series of natural products called Combretastatins. In August 1999, we entered into an exclusive license for the commercial development, use and sale of products or services covered by certain patent rights owned by Arizona State University. This agreement was subsequently amended in June 2002. From the inception of the agreement through December 31, 2011, we have paid a total of $2,500,000 in connection with this license. The agreement provides for additional payments in connection with the license arrangement upon the initiation of certain clinical trials or the completion of certain regulatory approvals, which payments could be accelerated upon the achievement of certain financial milestones, as defined in the agreement. The license agreement also provides for additional payments upon our election to develop certain additional compounds, as defined in the agreement. Future milestone payments under this agreement could total $200,000. We are also required to pay royalties on future net sales of products associated with these patent rights.
| ITEM | 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
At December 31, 2011, we did not hold any derivative financial instruments, commodity-based instruments or other long-term debt obligations. We have accounted for certain outstanding warrants issued in connection with our prior equity offerings as liabilities as of December 31, 2011.
We have adopted an Investment Policy, the primary objectives of which are to preserve principal, maintain proper liquidity to meet operating needs and maximize yields while preserving principal. Although our investments are subject to credit risk, we follow procedures to limit the amount of credit exposure in any single issue, issuer or type of investment. Our investments are also subject to interest rate risk and will decrease in value if market interest rates increase. However, due to the conservative nature of our investments and relatively short duration, we believe that interest rate risk is mitigated. Our cash and cash equivalents are maintained in U.S. dollar accounts. Although we may from time to time conduct trials and studies outside of the United States, we believe our exposure to foreign currency risk to be limited as the arrangements are typically in jurisdictions with relatively stable currencies.
| ITEM 8. | FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA |
See Item 15 for a list of our Financial Statements and Schedules and Supplementary Information filed as part of this Annual Report.
| ITEM 9. | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE |
Not applicable.
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| ITEM 9A. | CONTROLS AND PROCEDURES |
Evaluation of our Disclosure Controls and Procedures
The Securities and Exchange Commission requires that as of the end of the period covered by this Annual Report on Form 10-K, the Chief Executive Officer, CEO, and the Chief Financial Officer, CFO, evaluate the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, and report on the effectiveness of the design and operation of our disclosure controls and procedures. Based upon that evaluation, our CEO and CFO concluded that our disclosure controls and procedures were effective, as of December 31, 2011, to ensure that we record, process, summarize and report the information we must disclose in reports that we file or submit under the Exchange Act, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our CEO and CFO, as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting, identified in connection with the evaluation of such control that occurred during the fourth quarter of our fiscal year ended December 31, 2011, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Management Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our CEO and CFO, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2011 based on the framework in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on that evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2011.
This Annual Report 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.
Important Considerations
The effectiveness of our disclosure controls and procedures and our internal control over financial reporting is subject to various inherent limitations, including cost limitations, judgments used in decision making, assumptions about the likelihood of future events, the soundness of our systems, the possibility of human error, and the risk of fraud. Moreover, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions and the risk that the degree of compliance with policies or procedures may deteriorate over time. Because of these limitations, there can be no assurance that any system of disclosure controls and procedures or internal control over financial reporting will be successful in preventing all errors or fraud or in making all material information known in a timely manner to the appropriate levels of management. Because as of June 30, 2011 the Company’s public float value was below $75,000,000, Ernst & Young LLP was not required to issue an opinion on our internal control over financial reporting and, therefore, did not perform for the fiscal year ended December 31, 2011 an audit of our internal control over financial reporting pursuant to Section 404 of the Sarbanes Oxley Act of 2002.
| ITEM 9B. | OTHER INFORMATION |
None.
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| ITEM 10. | DIRECTORS , EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE |
The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Proposal 1 — Election of Directors,” “Board and Committee Meetings,” “Section 16(a) Beneficial Ownership Reporting Compliance,” “Executive Officers of the Company” and “Code of Conduct and Ethics” in the Company’s Proxy Statement for the 2012 Annual Meeting of Stockholders.
| ITEM 11. | EXECUTIVE COMPENSATION |
The response to this item is incorporated by reference from the discussion responsive thereto under the caption “Executive Compensation,” in the Company’s Proxy Statement for the 2012 Annual Meeting of Stockholders.
| ITEM 12. | SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS |
The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information,” in the Company’s Proxy Statement for the 2012 Annual Meeting of Stockholders.
| ITEM 13. | CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE |
The response to this item is incorporated by reference from the discussion responsive thereto under the captions “Certain Relationships and Related Transactions,” “Board and Committee Meetings” and “Executive Compensation” in the Company’s Proxy Statement for the 2012 Annual Meeting of Stockholders.
| ITEM 14. | PRINCIPAL ACCOUNTING FEES AND SERVICES |
The response to this item is incorporated by reference from the discussion responsive thereto under the caption “Audit Fees” in the Company’s Proxy Statement for the 2012 Annual Meeting of Stockholders.
| ITEM 15. | EXHIBITS, FINANCIAL STATEMENT SCHEDULES |
(a) The following documents are filed as part of this Annual Report on Form 10-K.
(1) Financial Statements
See financial statements listed in the accompanying “Index to Financial Statements” covered by the Report of Independent Registered Public Accounting Firm.
(2) Financial Statement Schedules
No schedules are submitted because they are not applicable, not required or because the information is included in the Consolidated Financial Statements as Notes to Consolidated Financial Statements.
(3) Exhibits
The following is a list of exhibits filed as part of this Annual Report on Form 10-K.
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Exhibit Number | Description | |
| 3.1 | Restated Certificate of Incorporation of the Registrant, as amended by Certificates of Amendment dated June 21, 1995, November 15, 1996, July 14, 2005, June 2, 2009, February 8, 2010, August 5, 2010 and February 22, 2011. xxxx | |
| 3.2 | Amended and Restated By-Laws of the Registrant.%%% | |
| 4.1 | Specimen Common Stock Certificate.* | |
| 4.2 | Warrant for the purchase of shares of common stock, dated February 19, 2008, issued by the Registrant to Kingsbridge Capital Limited.^^^^ | |
| 4.3 | Registration Rights Agreement, dated February 19, 2008, by and between the Registrant and Kingsbridge Capital Limited.^^^^ | |
| 4.4 | Form of Direct Investment Warrant, dated as of October 17, 2008. § | |
| 4.5 | Form of Five-year Warrant, dated as of July 15, 2009. €€ | |
| 4.6 | Registration Rights Agreement, dated as of March 10, 2010, by and among the Registrant and the Buyers named therein.WWWW | |
| 4.7 | Form of Series E Warrant.aaa | |
| 4.8 | Amendment No. 5 to Stockholder Rights Agreement, dated as of November 28, 2011, by and between the Registrant and American Stock Transfer & Trust Company, LLC. xxx | |
| 10.1@ | OXiGENE 1996 Stock Incentive Plan, as amended.+ | |
| 10.2 | Technology Development Agreement, dated as of May 27, 1997, between the Registrant and the Arizona Board of Regents, acting for and on behalf of Arizona State University.*** | |
| 10.3 | Research Collaboration and License Agreement, dated as of December 15, 1999, between OXiGENE Europe AB and Bristol-Myers Squibb Company.++ | |
| 10.4@ | Form of Compensation Award Stock Agreement for Non-Employee Directors, dated as of January 2, 2002. # | |
| 10.5 | Amendment and Confirmation of License Agreement No. 206-01.LIC, dated as of June 10, 2002, between the Registrant and the Arizona Board of Regents, acting for and on behalf of Arizona State University. # | |
| 10.6 | License Agreement No. 206-01.LIC by and between the Arizona Board of Regents, acting on behalf of and for Arizona State University, and OXiGENE Europe AB, dated August 2, 1999. & | |
| 10.7 | Research and License Agreement between the Registrant and Baylor University, dated June 1, 1999. & | |
| 10.8 | Agreement to Amend Research and License Agreement between the Registrant and Baylor University, dated April 23, 2002. & | |
| 10.9 | “Addendum” to Research and License Agreement between the Registrant and Baylor University, dated April 14, 2003. & | |
| 10.10@ | Employment Agreement, dated as of February 23, 2004, between the Registrant and James B. Murphy.% | |
| 10.11 | Stockholder Rights Agreement dated as of March 24, 2005, between the Registrant and American Stock Transfer and Trust Company, LLC. !! | |
| 10.12@ | Form of Incentive Stock Option Agreement under OXiGENE 2005 Stock Plan. $ | |
| 10.13@ | Form of Non-Qualified Stock Option Agreement under OXiGENE 2005 Stock Plan. $ | |
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Exhibit Number | Description | |
| 10.14@ | Form of Restricted Stock Agreement under OXiGENE 2005 Stock Plan. $ | |
| 10.15 | Amendment No. 1 to the Stockholder Rights Agreement by and between the Registrant and American Stock Transfer & Trust Company, LLC dated as of October 1, 2008. § | |
| 10.16@ | Form of Indemnification Agreement between the Registrant and its Directors.§§ | |
| 10.17@ | 409A Amendment to Employment Agreement by and between the Registrant and Mr. Murphy, dated as of December 30, 2008. §§§§ | |
| 10.18@ | Amendment No. 2 to Employment Agreement by and between the Registrant and Mr. Murphy, dated as of January 20, 2009. §§§§ | |
| 10.19 | Lease between Broadway 701 Gateway Fee LLC, A Delaware Limited Liability Company, as Landlord, and the Registrant, as Tenant, dated October 10, 2008. §§§§ | |
| 10.20 | Office Lease Agreement, dated April 21, 2009, between the Registrant and King Waltham LLC. §§§§§ | |
| 10.21@ | Employment Agreement by and between the Registrant and Dr. Langecker, dated as of June 10, 2009. $$$$$ | |
| 10.22 | Amended and Restated Purchase Option Agreement by and among the Registrant, Symphony ViDA, Inc. and Symphony ViDA Holdings LLC, dated as of July 2, 2009. € | |
| 10.23 | Termination Agreement by and among the Registrant, Symphony ViDA Holdings LLC, Symphony ViDA Investors LLC and Symphony ViDA, Inc., dated as of July 2, 2009. € | |
| 10.24 | Amendment No. 2 to Stockholder Rights Agreement by and between OXiGENE, Inc. and American Stock Transfer & Trust Company, LLC, dated as of October 14, 2009. £ | |
| 10.25 | Amendment No. 3 to Stockholder Rights Agreement, dated as of March 10, 2010, by and between the Registrant and American Stock Transfer and Trust Company, LLC.WWWW | |
| 10.26 | Securities Purchase Agreement, dated as of March 10, 2010, by and among the Registrant and the Buyers named therein.WWWW | |
| 10.27 | Voting Agreement, dated as of March 10, 2010, by and between the Registrant and Symphony ViDA Holdings LLC.WWWW | |
| 10.28 | Form of Amendment and Exchange Agreement, dated as of March 25, 2010, by and among the Registrant and the Investors named therein.a | |
| 10.29 | Sales Agreement, dated July 21, 2010, between OXiGENE, Inc. and McNicoll, Lewis & Vlak LLC.aa | |
| 10.30 | Form of Warrant Exchange Agreement, dated as of January 18, 2011, by and between the Registrant and each Investor named therein.aaa | |
| 10.31 | Form of Voting Agreement, dated as of January 18, 2011, by and between the Registrant and each of its directors, executive officers and Symphony ViDA Holdings LLC.aaa | |
| 10.32 | Form of Amendment No. 4 to Stockholder Rights Agreement, dated as of January 18, 2011, by and between the Registrant and American Stock Transfer and Trust Company, LLC.aaa | |
| 10.33@ | OXiGENE, Inc. 2005 Stock Plan (as amended on October 31, 2011). x | |
| 10.34@ | OXiGENE, Inc. Amended and Restated Non-Employee Director Compensation Policy, effective September 20, 2011. xx | |
| 10.35 | Purchase Agreement, dated as of November 28, 2011, by and between the Registrant and Lincoln Park Capital Fund, LLC. xxx | |
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Exhibit Number | Description | |
| 10.36 | Registration Rights Agreement, dated as of November 28, 2011, by and between the Registrant and Lincoln Park Capital Fund, LLC. xxx | |
| 10.37@ | Amended and Restated Employment Agreement, dated as of December 15, 2011, by and between the Registrant and Dr. Peter Langecker. X | |
| 14.1 | Code of Conduct. #### | |
| 23.1 | Consent of Ernst & Young LLP. X | |
| 31.1 | Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a). X | |
| 31.2 | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a). X | |
| 32.1 | Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. X | |
| 101 | Interactive Data Files for the fiscal years ended December 31, 2011 and December 31, 2010
101.INS - XBRL Instance Document** 101.SCH - XBRL Taxonomy Extension Schema** 101.CAL - XBRL Taxonomy Extension Calculation Linkbase** 101.DEF - XBRL Taxonomy Extension Definition Linkbase** 101.LAB - XBRL Taxonomy Extension Label Linkbase** 101.PRE - XBRL Taxonomy Extension Presentation Linkbase** | |
| * | Incorporated by reference to the Registrant’s Registration Statement on Form S-1 (file no. 33-64968) and any amendments thereto. |
| ** | Users of this interactive data file are advised pursuant to Rule 406T of Regulation S-T that this interactive data file is deemed not filed or part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of section 18 of the Securities Exchange Act of 1934, and otherwise is not subject to liability under these sections. |
| *** | Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 1997. |
| # | Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2002. |
| #### | Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2002. |
| + | Incorporated by reference to the Registrant’s Registration Statement on Form S-8 (file no. 333-92747) and any amendments thereto. |
| ++ | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on December 28, 1999. |
| & | Incorporated by reference to Amendment No. 3 to the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2002. |
| % | Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2004. |
| !! | Incorporated by reference to the Registrant’s Registration Statement on Form 8-A, dated March 30, 2005 and any amendments thereto. |
| $ | Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2005. |
| %%% | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on December 20, 2007. |
| ^^^^ | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on February 21, 2008. |
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| § | Incorporated by reference to the Registrant’s Amendment No. 1 to its Current Report on Form 8-K/A, filed on October 10, 2008. |
| §§ | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on October 24, 2008. |
| §§§§ | Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008. |
| §§§§§ | Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2009. |
| $$$$$ | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on June 17, 2009. |
| € | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on July 7, 2009. |
| €€ | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on July 15, 2009. |
| £ | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on October 16, 2009. |
| WWWW | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on March 11, 2010. |
| a | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on March 26, 2010. |
| aa | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on July 21, 2010. |
| aaa | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on January 19, 2011. |
| x | Incorporated by reference to the Registrant’s Registration Statement on Form S-8 filed on October 31, 2011. |
| xx | Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2011. |
| xxx | Incorporated by reference to the Registrant’s Registration Statement on Form 8-K, filed on November 28, 2011. |
| xxxx | Incorporated by reference to the Registrant’s Registration Statement on Form S-1, filed on December 22, 2011. |
| +++ | Confidential treatment requested as to certain portions of the document, which portions have been omitted and filed separately with the Securities and Exchange Commission. |
| @ | Management contract or compensatory plan or arrangement. |
| X | Filed with this report. |
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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, thereunto duly authorized.
| OXiGENE, Inc. | ||
| By: | /S/ PETER J. LANGECKER | |
Peter J. Langecker Chief Executive Officer | ||
Date: March 28, 2012
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature | Title | Date | ||
/S/ PETER J. LANGECKER
Peter J. Langecker | Chairman of the Board and Chief Executive Officer (Principal executive officer) | March 28, 2012 | ||
/S/ JAMES B. MURPHY
James B. Murphy | Vice President and Chief Financial Officer (Principal financial and accounting officer) | March 28, 2012 | ||
/S/ TAMAR D. HOWSON
Tamar D. Howson | Director | March 28, 2012 | ||
/S/ GERALD MCMAHON
Gerald McMahon | Director | March 28, 2012 | ||
/S/ WILLIAM D. SCHWIETERMAN
William D. Schwieterman | Director | March 28, 2012 | ||
/S/ ALASTAIR J.J. WOOD
Alastair J.J. Wood M.D. | Director | March 28, 2012 | ||
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Form 10-K Item 15(a)(1)
OXiGENE, Inc.
Index to Consolidated Financial Statements
The following consolidated financial statements of OXiGENE, Inc. are included in Item 8:
| F-2 | ||||
| F-3 | ||||
| F-4 | ||||
| F-5 | ||||
| F-6 | ||||
| F-7 — F-27 |
F-1
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Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders of
OXiGENE, Inc.
We have audited the accompanying consolidated balance sheets of OXiGENE, Inc. as of December 31, 2011 and 2010, and the related consolidated statements of operations, stockholders’ equity (deficit), and cash flows for each of the three years in the period ended December 31, 2011. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. We were not engaged to perform an audit of the Company’s internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit 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 financial statements referred to above present fairly, in all material respects, the consolidated financial position of OXiGENE, Inc. at December 31, 2011 and 2010, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 2011, in conformity with U.S. generally accepted accounting principles.
The accompanying consolidated financial statements have been prepared assuming that OXiGENE, Inc. will continue as a going concern. As more fully described in Note 1, the Company has incurred recurring operating losses and has significantly reduced the development of its most advanced product candidates. In order to significantly further develop its product pipeline, the Company will be required to raise additional capital, alternative means of financial support, or both. The ability of the Company to raise additional capital or alternative sources of financing is uncertain. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The 2011 consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
/s/ Ernst & Young LLP
Boston, Massachusetts
March 28, 2012
F-2
Table of Contents
OXiGENE, Inc.
(All Amounts in thousands
except per share amounts)
| December 31, 2011 | December 31, 2010 | |||||||
ASSETS |
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Current assets: | ||||||||
Cash and cash equivalents | $ | 9,972 | $ | 4,602 | ||||
Restricted cash | 20 | 75 | ||||||
Prepaid expenses | 582 | 256 | ||||||
Other current assets | 73 | 75 | ||||||
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Total current assets | 10,647 | 5,008 | ||||||
Furniture and fixtures, equipment and leasehold improvements | 643 | 1,512 | ||||||
Accumulated depreciation | (609 | ) | (1,425 | ) | ||||
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| 34 | 87 | |||||||
License agreements, net of accumulated amortization of $1,211 and | 289 | 386 | ||||||
Other assets | 86 | 86 | ||||||
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Total assets | $ | 11,056 | $ | 5,567 | ||||
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LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
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Current liabilities: | ||||||||
Accounts payable | $ | 261 | $ | 458 | ||||
Accrued research and development | 480 | 2,125 | ||||||
Accrued restructuring | 653 | — | ||||||
Accrued other | 859 | 628 | ||||||
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Total current liabilities | 2,253 | 3,211 | ||||||
Derivative liability long term | 6 | 7,611 | ||||||
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Total liabilities | 2,259 | 10,822 | ||||||
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Commitments and contingencies | ||||||||
Stockholders’ equity (deficit) | ||||||||
Preferred Stock, $.01 par value, 15,000 shares authorized; 0 shares issued and outstanding at December 31, 2011 and December 31, 2010 | — | — | ||||||
Common stock, $.01 par value, 300,000 shares authorized and 15,177 shares issued and outstanding at December 31, 2011; 300,000 shares authorized and 5,501 shares issued and outstanding at December 31, 2010 | 152 | 55 | ||||||
Additional paid-in capital | 225,998 | 202,390 | ||||||
Accumulated deficit | (217,353 | ) | (207,700 | ) | ||||
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Total stockholders’ equity (deficit) | 8,797 | (5,255 | ) | |||||
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Total liabilities and stockholders’ equity (deficit) | $ | 11,056 | $ | 5,567 | ||||
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See accompanying notes.
F-3
Table of Contents
OXiGENE, Inc.
Consolidated Statements of Operations
(All amounts in thousands,
except per share amounts)
| Years ended December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
Operating costs and expenses: | ||||||||||||
Research and development | $ | 5,291 | $ | 12,114 | $ | 22,256 | ||||||
General and administrative | 5,375 | 5,885 | 8,900 | |||||||||
Restructuring (Note 6) | 1,226 | 510 | — | |||||||||
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Total operating costs and expenses | 11,892 | 18,509 | 31,156 | |||||||||
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Loss from operations | (11,892 | ) | (18,509 | ) | (31,156 | ) | ||||||
Change in fair value of warrants and other financial instruments | 2,222 | (6,018 | ) | 2,166 | ||||||||
Investment income | 7 | 17 | 110 | |||||||||
Other income (expense), net | 10 | 740 | (63 | ) | ||||||||
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Consolidated net loss | $ | (9,653 | ) | $ | (23,770 | ) | $ | (28,943 | ) | |||
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Less: net loss attributed to non controlling interest | $ | — | $ | — | $ | (4,215 | ) | |||||
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Net loss attributed to OXiGENE, Inc. | $ | (9,653 | ) | $ | (23,770 | ) | $ | (24,728 | ) | |||
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Excess purchase price over carrying value of noncontrolling interest acquired in Symphony ViDA, Inc | $ | — | $ | — | $ | (10,383 | ) | |||||
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Net loss applicable to common stock | $ | (9,653 | ) | $ | (23,770 | ) | $ | (35,111 | ) | |||
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Basic and diluted net loss per share attributed to OXiGENE, Inc. common shares | $ | (0.86 | ) | $ | (5.96 | ) | $ | (13.15 | ) | |||
Weighted-average number of common shares outstanding | 11,167 | 3,988 | 2,671 | |||||||||
(1) Includes share based compensation expense as follows: | ||||||||||||
Research and development | $ | 301 | $ | 245 | $ | 206 | ||||||
General and administrative | 550 | 707 | 324 | |||||||||
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Total share based compensation expense | $ | 851 | $ | 952 | $ | 530 | ||||||
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See accompanying notes.
F-4
Table of Contents
OXiGENE, Inc.
Consolidated Statements of Stockholders’ Equity (Deficit)
(All amounts in thousands)
| Stock | ||||||||||||||||||||||||||||||||
| Shares | $ | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive | Total OXiGENE, Inc. Stockholder | Non Controlling Interest in Symphony | Total Equity/ (Deficit) | |||||||||||||||||||||||||
Balance December 31, 2008 | 2,315 | 23 | 178,596 | (159,202 | ) | (110 | ) | 19,307 | 9,432 | 28,739 | ||||||||||||||||||||||
Unrealized gain from available-for-sale securities | — | — | — | — | 110 | 110 | — | 110 | ||||||||||||||||||||||||
Net loss | — | — | — | (24,728 | ) | — | (24,728 | ) | (4,215 | ) | (28,943 | ) | ||||||||||||||||||||
Comprehensive loss | (24,618 | ) | (4,215 | ) | (28,833 | ) | ||||||||||||||||||||||||||
Symphony ViDA, Inc. acquisition (including | 500 | 5 | 5,125 | — | — | 5,130 | (5,217 | ) | (87 | ) | ||||||||||||||||||||||
Issuance of common stock in lieu of compensation for the Board of Directors | 15 | — | 321 | — | — | 321 | — | 321 | ||||||||||||||||||||||||
Elimination of the CEFF warrant derivative liability due to the Symphony ViDA, Inc. acquisition | — | — | 155 | — | — | 155 | — | 155 | ||||||||||||||||||||||||
Issuance of common stock in direct registration net of costs and fair value of warrants issued of $4,055 | 313 | 3 | 4,971 | — | — | 4,974 | — | 4,974 | ||||||||||||||||||||||||
Issuance of common stock under employee stock purchase plan | 3 | — | 125 | — | — | 125 | — | 125 | ||||||||||||||||||||||||
Employee stock based compensation expense | — | — | 407 | — | — | 407 | — | 407 | ||||||||||||||||||||||||
Forfeiture of restricted stock | (9 | ) | — | (2 | ) | — | — | (2 | ) | — | (2 | ) | ||||||||||||||||||||
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Balance December 31, 2009 | 3,137 | 31 | 189,698 | (183,930 | ) | — | 5,799 | — | 5,799 | |||||||||||||||||||||||
Net loss | — | — | — | (23,770 | ) | — | (23,770 | ) | — | (23,770 | ) | |||||||||||||||||||||
Issuance of common stock and common stock warrants in connection with the private placement financing, net of expenses of $ 877 | 329 | 3 | (316 | ) | — | — | (313 | ) | — | (313 | ) | |||||||||||||||||||||
Reclass of CEFF warrants to derivative liability in March 2010 due to private placement warrants | — | — | (103 | ) | — | — | (103 | ) | — | (103 | ) | |||||||||||||||||||||
Exercise of warrants issued in private placement financing | 1,347 | 14 | 8,241 | — | — | 8,255 | — | 8,255 | ||||||||||||||||||||||||
Issuance of common stock under ATM, net of expenses of $ 288 | 664 | 7 | 3,799 | — | — | 3,806 | — | 3,806 | ||||||||||||||||||||||||
Issuance of common stock in lieu of compensation to Board of Directors | 19 | — | 325 | — | — | 325 | — | 325 | ||||||||||||||||||||||||
Issuance of common stock under employee stock purchase plan | 4 | — | 33 | — | — | 33 | — | 33 | ||||||||||||||||||||||||
Employee stock based compensation expense | — | — | 687 | — | — | 687 | — | 687 | ||||||||||||||||||||||||
Exercise of stock options | 1 | — | 26 | — | — | 26 | — | 26 | ||||||||||||||||||||||||
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Balance December 31, 2010 | 5,501 | $ | 55 | $ | 202,390 | $ | (207,700 | ) | $ | — | $ | (5,255 | ) | $ | — | $ | (5,255 | ) | ||||||||||||||
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Net loss | — | — | — | (9,653 | ) | — | (9,653 | ) | — | (9,653 | ) | |||||||||||||||||||||
Issuance of common stock in connection with the private placement warrant exchange | 1,554 | 16 | 5,367 | — | — | 5,383 | — | 5,383 | ||||||||||||||||||||||||
Issuance of common stock under ATM, net of expenses of $ 1,013 | 7,793 | 78 | 17,068 | — | — | 17,146 | — | 17,146 | ||||||||||||||||||||||||
Issuance of common stock for the initial commitment fee in connection with the LPC purchase agreement | 300 | 3 | 311 | — | — | 314 | — | 314 | ||||||||||||||||||||||||
Issuance of common stock in lieu of compensation to Board of Directors | 26 | — | 108 | — | — | 108 | — | 108 | ||||||||||||||||||||||||
Issuance of common stock under employee stock purchase plan | 3 | — | 8 | — | — | 8 | — | 8 | ||||||||||||||||||||||||
Reclass of CEFF warrants to equity from derivative liability due to warrant exchange | — | — | 3 | — | — | 3 | — | 3 | ||||||||||||||||||||||||
Employee stock based compensation expense | — | — | 743 | — | — | 743 | — | 743 | ||||||||||||||||||||||||
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Balance December 31, 2011 | 15,177 | $ | 152 | $ | 225,998 | $ | (217,353 | ) | $ | — | $ | 8,797 | $ | — | $ | 8,797 | ||||||||||||||||
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See accompanying notes.
F-5
Table of Contents
OXiGENE, Inc
Consolidated Statements of Cash Flows
(Amounts in thousands)
| Years ended December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
Operating activities: | ||||||||||||
Net loss attributed to OXiGENE, Inc. | $ | (9,653 | ) | $ | (23,770 | ) | $ | (24,728 | ) | |||
Loss attributed to noncontrolling interests | (4,215 | ) | ||||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||
| Change in fair value of warrants and other financial instruments | (2,222 | ) | 6,018 | (2,166 | ) | |||||||
Depreciation | 53 | 96 | 123 | |||||||||
Amortization of license agreement | 97 | 98 | 97 | |||||||||
Rent loss accrual | — | — | (60 | ) | ||||||||
Stock-based compensation | 851 | 952 | 778 | |||||||||
Changes in operating assets and liabilities: | ||||||||||||
Restricted cash | 55 | 65 | (140 | ) | ||||||||
Prepaid expenses and other current assets | (9 | ) | 457 | (210 | ) | |||||||
Accounts payable, accrued expenses and other payables | (956 | ) | (4,343 | ) | 1,852 | |||||||
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Net cash used in operating activities | (11,784 | ) | (20,427 | ) | (28,669 | ) | ||||||
Investing activities: | ||||||||||||
Proceeds from sale of available-for-sale securities | — | — | 753 | |||||||||
Proceeds from sale of marketable securities held by Symphony ViDA, Inc | — | — | 2,286 | |||||||||
Purchase of furniture, fixtures and equipment | — | — | (109 | ) | ||||||||
Proceeds from sale of fixed assets | — | — | 4 | |||||||||
Changes in other assets | — | 3 | — | |||||||||
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Net cash provided by investing activities | — | 3 | 2,934 | |||||||||
Financing activities: | ||||||||||||
Proceeds from issuance of common stock, net of acquisition costs | 17,146 | 11,044 | 9,029 | |||||||||
Proceeds from Symphony ViDA acquisition, net of acquisition costs | — | — | 12,289 | |||||||||
Proceeds from exercise of employee stock plans | 8 | 50 | 74 | |||||||||
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Net cash provided by financing activities | 17,154 | 11,094 | 21,392 | |||||||||
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Increase (decrease) in cash and cash equivalents | 5,370 | (9,330 | ) | (4,343 | ) | |||||||
Cash and cash equivalents at beginning of period | 4,602 | 13,932 | 18,275 | |||||||||
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Cash and cash equivalents at end of period | $ | 9,972 | $ | 4,602 | $ | 13,932 | ||||||
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Non- cash Disclosures: | ||||||||||||
Issuance of common stock in connection with the private placement warrant exchange | $ | 5,383 | $ | — | $ | — | ||||||
Issuance of common stock for the initial commitment fee in connection with the LPC purchase agreement | $ | 314 | $ | — | $ | — | ||||||
Reclass of CEFF warrants to equity from derivative liability due to warrant exchange | $ | 3 | $ | — | $ | — | ||||||
Fair market value of private placement warrants at issuance | $ | — | $ | 11,868 | $ | 4,055 | ||||||
Fair market value reclassification of CEFF warrants to liabilities in connection with private placement | $ | — | $ | 103 | $ | 155 | ||||||
Fair market value of warrants at exercise | $ | — | $ | 7,645 | $ | — | ||||||
See accompanying notes.
F-6
Table of Contents
OXiGENE, INC.
Notes to Consolidated Financial Statements
December 31, 2011
1. Description of Business and Significant Accounting Policies
Description of Business
OXiGENE, Inc. (the “Company”), incorporated in 1988 in the state of New York and reincorporated in 1992 in the state of Delaware, is a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases. OXiGENE’s primary focus is the development of product candidates referred to as vascular disrupting agents, or VDAs, that selectively disable and destroy abnormal blood vessels that provide solid tumors a means of growth and survival and also are associated with visual impairment in a number of ophthalmological diseases and conditions.
The Company intends to primarily target the development of its product candidates for the treatment of rare cancers that will be eligible for orphan drug status from the Food and Drug Administration, or FDA. OXiGENE’s lead candidate, ZYBRESTAT, has been awarded orphan drug status by the FDA and the European Commission in the European Union for the treatment of advanced anaplastic thyroid cancer, or ATC, and for the treatment of medullary, Stage IV papillary and Stage IV follicular thyroid cancers. The FDA has also granted Fast Track status to ZYBRESTAT for the treatment of regionally advanced and/or metastatic ATC, as well as in ovarian cancer.
By focusing on developing ZYBRESTAT in ATC, and potentially pursuing other rare or orphan indications, the Company believes it will be able to take advantage of significant benefits associated with orphan drug status, such as:
| Ÿ | Study design assistance from the appropriate FDA center, |
| Ÿ | Exemption from application-filing fees, |
| Ÿ | Possible grant funding for Phase 1 and 2 clinical trials, |
| Ÿ | Tax credits for some clinical research expenses, and |
| Ÿ | Seven years of marketing exclusivity after the approval of the drug. |
The Orphan Drug Act was passed in January 1983 to stimulate the research, development, and approval of products that treat rare diseases. An orphan drug is defined as a product that treats a rare disease affecting fewer than 200,000 patients in the United States. Drugs are granted orphan status for a specific indication.
To date, more than 400 subjects have been treated with ZYBRESTAT in human clinical trials, and the drug candidate has generally been observed to be well-tolerated.
In February 2011, the Company’s board of directors voted unanimously to implement a 1:20 reverse stock split of the Company’s common stock, following authorization of the reverse split by a shareholder vote on December 21, 2010. The reverse split became effective on February 22, 2011. All of the share and per share amounts, except for the per share fair value amounts, discussed and shown in the consolidated financial statements and notes have been adjusted to reflect the effect of this reverse split.
On July 21, 2010, the Company entered into an “at the market” (ATM) equity offering sales agreement with McNicoll, Lewis & Vlak LLC, (MLV), pursuant to which it may issue and sell shares of our common stock from time to time through MLV acting as its sales agent and underwriter. Sales of OXiGENE common stock through MLV, are made on the principal trading market of the Company’s common stock by means of ordinary brokers’ transactions at market prices, in block transactions or as otherwise agreed by MLV and OXiGENE. MLV uses its commercially reasonable efforts to sell our common stock from time to time, based upon our instructions (including any price, time or size limits we may impose). OXiGENE pays MLV a commission rate of up to 7.0% of the gross sales price per share of any common stock sold through MLV as agent under the sales agreement. During the Company’s fiscal year 2011, it sold approximately 7,794,000 shares of OXiGENE common stock for
F-7
Table of Contents
OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
net proceeds of approximately $17,146,000. Currently, OXiGENE is not able to sell additional shares under this ATM due to SEC limitations on the number of shares issuable pursuant to a Form S-3 registration statement in a primary offering by smaller reporting companies such as the Company. OXiGENE expects to be able to resume such sales in the second half of 2012, should it meet the issuance criteria of the SEC and NASDAQ.
On September 1, 2011, OXiGENE announced a restructuring plan, which included employee terminations, designed to focus its capital resources on the Company’s most promising early-stage clinical programs and further reduce its cash utilization. OXiGENE offered severance benefits to the terminated employees, and has recorded a total charge of approximately $1,226,000, primarily associated with personnel-related termination costs. In order to provide for an orderly transition, the Company implemented the reduction in work force in a phased manner. Substantially all of the charge represents cash expenditures. Upon completion of the restructuring activities outlined above, OXiGENE expects to reduce expenses from fiscal 2011 levels by an annual amount of approximately $2,000,000. The Company’s ability to achieve this anticipated cost reduction is contingent upon OXiGENE continuing to conduct only the projects to which the Company is currently committed. This planned level of cash utilization, does not provide for the initiation of any significant projects to further the development of the Company’s most advanced product candidates, primarily ZYBRESTAT in ATC. OXiGENE will require significant additional capital resources in order for significant further development to continue.
In November 2011, OXiGENE entered into a purchase agreement for the sale, from time to time, of up to $20,000,000 of its common stock with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor. The proceeds from any sales under this purchase agreement will be used to further develop the Company’s late and early-stage clinical pipeline and to fund the Company’s ongoing operations. During the 36-month term of the purchase agreement, the Company controls the timing and amount of any sales to LPC, if and when it decides, in accordance with the purchase agreement. LPC has no right to require the Company to sell any shares to LPC, but LPC is obligated to make purchases as OXiGENE directs, subject to certain conditions, which include the continuing effectiveness of a registration statement filed with the U.S. Securities and Exchange Commission covering the resale of the shares that may be issued to LPC and limitations related to the market value of the Company’s common stock. There is no guarantee that funding from LPC will be available when needed, or at all, or that the Company will be able to maintain effectiveness of the aforementioned registration statement. There are no upper limits to the price LPC may pay to purchase the Company’s common stock and the purchase price of the shares related to any future sales will be based on the prevailing market prices of the Company’s shares immediately preceding the notice of sale to LPC without any fixed discount. The agreement may be terminated by OXiGENE at any time, at its sole discretion, without any cost or penalty. No amounts were received under this facility during 2011.
In December 2011, OXiGENE established a partnership agreement with Azanta Danmark A/S, or Azanta, to provide access to ZYBRESTAT for the treatment of patients in a specified territory with ATC on a compassionate use basis. The Company’s newly-formed Named Patient Program to be managed by Azanta, provides a regulatory mechanism to allow healthcare professionals in the territory to prescribe ZYBRESTAT to individual ATC patients while it is still in development. Under the terms of the agreement, OXiGENE will provide ZYBRESTAT to Azanta. Azanta will serve as exclusive distributor for ZYBRESTAT in the specified territory for this purpose and will provide ZYBRESTAT to physicians solely to treat ATC on a compassionate use basis in the territory covered by the agreement until such time as ZYBRESTAT may obtain marketing approval in that territory. The territory includes the European Union, including the Nordic countries and Switzerland, and Canada, and the agreement may also be expanded to include other countries on a country-by-country basis. OXiGENE and Azanta will cooperate on regulatory activities relating to ZYBRESTAT for the treatment of ATC within the territory. There will be no transfer of ownership of intellectual property rights for ZYBRESTAT to Azanta under the terms of the agreement. We do not expect to receive significant income from Azanta under this arrangement. No revenue was recognized nor was any cash received under this agreement during 2011.
F-8
Table of Contents
OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
In addition to the LPC purchase agreement referenced above, the Company is aggressively pursuing other forms of capital infusion including public or private financing, strategic partnerships or other arrangements with organizations that have capabilities and/or products that are complementary to our the Company’s capabilities and/or products, in order to continue the development of our product candidates. However, there can be no assurances that the Company will complete any strategic alliances or collaborative development agreements, and the terms of such arrangements may not be advantageous to the Company.
We have experienced net losses every year since our inception and, as of December 31, 2011, had an accumulated deficit of approximately $217,353,000. We expect to incur significant additional operating losses over at least the next several years, principally as a result of our continuing clinical trials and anticipated research and development expenditures. The principal source of our working capital to date has been the proceeds of private and public equity financings and to a lesser extent the exercise of warrants and stock options. We currently have no recurring material amount of licensing or other income. As of December 31, 2011, we had approximately $9,992,000 in cash, restricted cash and cash equivalents.
Based on the Company’s limited ongoing programs and operations and taking into consideration the expected reductions in cash utilization resulting from the Company’s September 2011 reduction in force, the Company expects its existing cash and cash equivalents to support its operations through the first quarter of 2013. However, this level of cash utilization does not provide for the initiation of any significant projects to further the development of the Company’s most advanced product candidates, primarily ZYBRESTAT in ATC. Any significant further development of ZYBRESTAT or other capital intensive activities will be contingent upon the Company’s ability to raise additional capital in addition to the existing financing arrangements.
OXiGENE’s ongoing capital requirements will depend on numerous factors, including: the progress and results of preclinical testing and clinical trials of its product candidates under development, including ZYBRESTAT and OXi4503; the costs of complying with FDA and other regulatory agency requirements, including addressing the findings set forth by the FDA in its correspondence to the Company in March 2012, which will be significant – as described in the Risk Factors above regarding the conduct of clinical trials and regulatory requirements; the progress of its research and development programs; the time and costs expended and required to obtain any necessary or desired regulatory approvals; the resources, if any, that the Company devotes to develop manufacturing methods and advanced technologies; OXiGENE’s ability to enter into licensing arrangements, including any unanticipated licensing arrangements that may be necessary to enable it to continue the Company’s development and clinical trial programs; the costs and expenses of filing, prosecuting and, if necessary, enforcing OXiGENE’s patent claims, or defending against possible claims of infringement by third-party patent or other technology rights; the cost of commercialization activities and arrangements, if any, undertaken by the Company; and, if and when approved, the demand for OXiGENE’s products, which demand depends in turn on circumstances and uncertainties that cannot be fully known, understood or quantified unless and until the time of approval, including the range of indications for which any product is granted approval.
Additional funding may not be available to OXiGENE on acceptable terms, or at all. If the Company is unable to access additional funds when needed, it may not be able to continue the development of its product candidates or the Company could be required to delay, scale back or eliminate some or all of its development programs and other operations. Any additional equity financing, if available to the Company, may not be available on favorable terms, most likely will be dilutive to its current stockholders and debt financing, if available, may involve restrictive covenants. If the Company accesses funds through collaborative or licensing arrangements, it may be required to relinquish rights to some of its technologies or product candidates that it would otherwise seek to develop or commercialize on its own, on terms that are not favorable to the Company. The Company’s ability to access capital when needed is not assured and, if not achieved on a timely basis, will materially harm its business, financial condition and results of operations. The Company’s ability to raise additional capital could also be impaired if its common shares lose their status on The NASDAQ Capital Market,
F-9
Table of Contents
OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
and trade in the over-the-counter market. These uncertainties create substantial doubt about the Company’s ability to continue as a going concern. The Report of Independent Registered Accounting Firm at the beginning of the Consolidated Financial Statements section of this Form 10-K includes a going concern explanatory paragraph.
The accompanying financial statements have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.
Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period. Actual results could differ from those estimates.
Concentration of Credit Risk
The Company has no significant off balance sheet concentrations of credit risk. Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash and cash equivalents. The Company holds its cash and cash equivalents at one financial institution.
Cash, Restricted Cash and Cash Equivalents
The Company considers all highly liquid financial instruments with maturities of three months or less when purchased to be cash equivalents. The Company has $20,000 and $75,000 of restricted cash as of December 31, 2011 and 2010, respectively that is used to secure financing through a Company credit card. This amount is separated from cash and cash equivalents on the Consolidated Balance Sheet.
Fair Value
The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. Fair value hierarchy is now established that prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of our investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs:
Level 1 inputs | Quoted prices in active markets; | |
Level 2 inputs | Generally include inputs with other observable qualities, such as quoted prices in active markets for similar assets or quoted prices for identical assets in inactive markets; and | |
Level 3 inputs | Valuations based on unobservable inputs. |
As of December 31, 2011 and 2010, OXiGENE did not hold any assets or liabilities subject to these standards, except the derivative liabilities and other financial instruments discussed below in“Accounting for Derivative Financial Instruments Indexed to and Potentially Settled in the Company’s Common stock” which are level 3 inputs. Effective January 1, 2009, the Company adopted the fair value standards as they relate to non-recurring fair value measurements, such as the assessment of goodwill and other long-lived assets for impairment.
Furniture and Fixtures, Equipment and Leasehold Improvements
Furniture and fixtures, equipment and leasehold improvements are recorded at cost. Depreciation is recorded using the straight-line method over the lesser of the estimated useful lives of the assets, which range from three to five years, or the applicable lease term.
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Table of Contents
OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
License Agreements
The present value of the amount paid under the license agreement with Arizona State University (see Note 3) has been capitalized and is being amortized over the term of the agreement (approximately 15.5 years). The Company is required to perform an impairment analysis of its long-lived assets if triggering events occur. The Company reviews for such triggering events, such as a going concern opinion and continuing losses, periodically. The license agreement provides for additional payments in connection with the license arrangement upon the initiation of certain clinical trials or the completion of certain regulatory approvals, which payments could be accelerated upon the achievement of certain financial milestones as defined in the agreement. The Company expenses these payments to research and development in the period the obligation becomes both probable and estimable.
Accrued Research and Development
The Company charges all research and development expenses, both internal and external costs, to operations as incurred. The Company’s research and development costs represent expenses incurred from the engagement of outside professional service organizations, product manufacturers and consultants associated with the development of the Company’s potential product candidates. The Company recognizes expenses associated with these arrangements based on the completion of activities as specified in the applicable contracts. Costs incurred under fixed-fee contracts are expensed ratably over the contract period absent any knowledge that the services will be performed other than ratably. Costs incurred under contracts with clinical trial sites and principal investigators are generally accrued on a patient-treated basis consistent with the terms outlined in the contract. In determining costs incurred on some of these programs, the Company takes into consideration a number of factors, including estimates and input provided by internal program managers. Upon termination of such contracts, the Company is normally only liable for costs incurred and committed to date. As a result, accrued research and development expenses represent the Company’s reasonably estimated contractual liability to outside service providers at any particular point in time.
Accounting for Derivative Financial Instruments Indexed to and Potentially Settled in the Company’s Common stock
The Company evaluates all derivative financial instruments issued in connection with its equity offerings when determining the proper accounting treatment for such instruments in the Company’s financial statements. The Company considers a number of generally accepted accounting principles to determine such treatment. The Company performs a number of steps to evaluate the features of the instrument against the guidance provided in the accounting pronouncements in order to determine the appropriate accounting treatment. The Company’s policy with regard to settling outstanding financial instruments is to settle those with the earliest maturity date first which essentially sets the order of preference for settling the awards. In the majority of circumstances, the Company utilizes the Black Scholes method to determine the fair value of its derivative financial instruments. In some cases, where appropriate, the Company utilizes the Binomial method to determine the fair value of such derivative financial instruments. Key valuation factors in determining the fair value include the current stock price as of the date of measurement, the exercise price, the remaining contractual life, expected volatility for the instrument and the risk-free interest rate. Changes in fair value are recorded as a gain or loss in the Company’s Statement of Operations with the corresponding amount recorded as an adjustment to liability on its Balance Sheet. The expected volatility factor, in particular, is subject to significant variability from measurement period to measurement period and can result in large gains or losses from period to period.
Revenue Recognition
In December 2011, OXiGENE established a distribution agreement to provide access to ZYBRESTAT for the treatment of patients in a specified territory with ATC on a compassionate use basis. The agreement with OXiGENE’s distribution partner provides that upon the receipt of ZYBRESTAT by the partner for distribution
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Table of Contents
OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
and sale to compassionate use patients, the distributor has 30 days to inspect the product for defects and to ensure that the product conforms to the warranties made by the Company. If the distributor does not notify OXiGENE of any defective product within the 30-day period it will be deemed to have accepted the product. Revenue is recognized based on product accepted at the conclusion of the 30-day inspection period. Also, Azanta will pay to OXiGENE, on a quarterly basis, an amount equal to 20% of Azanta’s gross margin, as defined in the agreement, on its sales in the preceding quarter. This revenue will be recognized upon notification from Azanta of the gross margin earned.
In addition, OXiGENE has licensed to a third party the Company’s formerly owned Nicoplex and Thiol Test technology. Revenue in connection with this license arrangement is earned based on sales of products or services utilizing this technology. Revenue is recognized under this agreement when payments are received due to the uncertainty of the timing of sales of products or services.
Stock-based Compensation
The Company expenses the estimated fair value of all share-based payments issued to employees over the vesting period. The Company has a 2005 Stock Plan (“2005 Plan”), which superseded its 1996 Stock Option Plan that provides for the award of stock options, restricted stock and stock appreciation rights to employees, directors and consultants to the Company. The Company also has a 2009 Employee Stock Purchase Plan (“2009 ESPP”).
Consolidation of Variable Interest Entity (VIE)
A variable interest entity (VIE) is (1) an entity that has equity that is insufficient to permit the entity to finance its activities without additional subordinated financial support, or (2) an entity that has equity investors that cannot make significant decisions about the entity’s operations or that do not absorb their proportionate share of the expected losses or do not receive the expected residual returns of the entity. A VIE should be consolidated by the party that is deemed to be the primary beneficiary, which is the party that has exposure to a majority of the potential variability in the VIE’s outcomes. The application of accounting policy to a given arrangement requires significant management judgment.
The Company consolidated the financial position and results of operations of ViDA (See Note 7) in accordance with proper accounting guidance. OXiGENE believes ViDA was by design a VIE because OXIGENE had a purchase option to acquire its outstanding voting stock at prices that are fixed based upon the date the option is exercised. The fixed nature of the purchase option price limited Symphony’s returns, as the investor in ViDA. Further, due to the direct investment from Holdings in OXiGENE common stock, as a related party ViDA was a VIE of which OXiGENE was the primary beneficiary. Upon OXiGENE exercising the purchase option in 2009, ViDA became a wholly-owned subsidiary of OXiGENE and ceased being a VIE.
Accounting and Reporting of Noncontrolling Interests
On January 1, 2009, the Company adopted (retrospectively for all periods presented) the new presentation requirements for noncontrolling interests required by ASC 810 Consolidations. Under ASC 810, earnings or losses attributed to the noncontrolling interests are reported as part of consolidated earnings and not as a separate component of income or expense. Accordingly, the Company reported the consolidated earnings of ViDA in its consolidated statement of operations from October 2008, when it entered into a strategic collaboration with Symphony, until July 20, 2009, when OXiGENE acquired 100% of the equity of ViDA pursuant to the Amended Purchase Option Agreement. Once becoming the Company’s wholly-owned subsidiary, the operating results of ViDA continued to be included in the Company’s consolidated statement of operations but were no longer subject to the presentation requirements applicable to noncontrolling interests. Losses incurred by ViDA prior to July 20, 2009 and attributable to Symphony, were charged to noncontrolling interest.
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OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
Patents and Patent Applications
The Company has filed applications for patents in connection with technologies being developed. The patent applications and any patents issued as a result of these applications are important to the protection of the Company’s technologies that may result from its research and development efforts. Costs associated with patent applications and maintaining patents are expensed as general and administrative expense as incurred.
Income Taxes
The Company accounts for income taxes based upon the provisions of ASC 740Income Taxes. Under ASC 740, deferred taxes are recognized using the liability method whereby tax rates are applied to cumulative temporary differences between carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes based on when and how they are expected to affect the tax return.
Subsequent Events
The Company reviews all activity subsequent to year end but prior to the issuance of the financial statements for events that could require disclosure or which could impact the carrying value of assets or liabilities as of the balance sheet date.
2. Furniture and Fixtures, Equipment and Leasehold Improvements
Furniture and fixtures, equipment and leasehold improvements consisted of the following at the dates indicated below:
| December 31, 2011 | December 31, 2010 | |||||||
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Leasehold improvements | $ | 25 | $ | 449 | ||||
Equipment | 462 | 647 | ||||||
Furniture and fixtures | 156 | 416 | ||||||
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Total gross assets | 643 | 1,512 | ||||||
Less accumulated depreciation | (609 | ) | (1,425 | ) | ||||
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Total property and equipment | $ | 34 | $ | 87 | ||||
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3. License agreements
In August 1999, the Company entered into an exclusive license agreement for the commercial development, use and sale of products or services covered by certain patent rights owned by Arizona State University. From the inception of the agreement through December 31, 2011, the Company has paid a total of $2,500,000 in connection with this license. The Company capitalized the net present value of the total amount paid under the initial terms of the license, or $1,500,000, and is amortizing this amount over the patent life or 15.5 years.
The Company expects to record amortization expense related to this license agreement of approximately $8,100 per month through November 2014. The net book value at December 31, 2011 and 2010 was $289,000 and $386,000 respectively.
4. Restructuring
On September 1, 2011, the Company announced a restructuring plan designed to focus the Company’s capital resources on its most promising early-stage clinical programs and further reduce its cash utilization. In connection with this restructuring, the Company recognized approximately $721,000 of research and
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Table of Contents
OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
development restructuring expenses and approximately $505,000 of general and administrative restructuring expenses in the year ended December 31, 2011. The restructuring expenses include severance payments, health and medical benefits and related taxes, which are expected to be paid through the end of fiscal 2012.
The following table sets forth the components of the Company’s restructuring for the year ended December 31, 2011 (in thousands):
| Amounts Paid Through | Adjustments for Foreign Exchange at | Amounts Accrued as of | ||||||||||||||||||||||
| Original Charges | Adjustment | Total Charges to Date | December 31, 2011 | |||||||||||||||||||||
General and Administrative Employee severance and related costs | $ | 425 | $ | 80 | $ | 505 | $ | (373 | ) | $ | — | $ | 132 | |||||||||||
Research and Development Employee severance and related costs | 721 | — | 721 | (178 | ) | (22 | ) | 521 | ||||||||||||||||
Total restructuring | $ | 1,146 | $ | 80 | $ | 1,226 | $ | (551 | ) | $ | (22 | ) | $ | 653 | ||||||||||
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In February 2010, the Company implemented a restructuring plan in which it terminated 20 full-time employees, or approximately 49% of its work force. The purpose of the restructuring was to focus the Company’s resources on its highest-value clinical assets and reduce its cash utilization. The restructuring expenses include severance payments, health and medical benefits and related taxes, which were paid through August 2010. The Company incurred severance and related costs of $458,000 for research and development employees and $52,000 for administrative employees in connection with this restructuring in fiscal 2010. No amounts related to the 2010 restructuring were outstanding as of December 31, 2010.
5. Accrued other
Accrued other consisted of the following at the dates indicated below:
| December 31, 2011 | December 31, 2010 | |||||||
| (in thousands) | ||||||||
Accounting and Legal | $ | 481 | $ | 206 | ||||
Payroll | 78 | 251 | ||||||
Other | 300 | 171 | ||||||
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Total Accrued other | $ | 859 | $ | 628 | ||||
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6. Stockholders’ Equity (Deficit) — Common and Preferred Shares
The Company had 300,000,000 shares of common stock authorized as of December 31, 2011 and December 31, 2010. As of December 31, 2011, the Company had 15,177,000 shares of common stock issued and outstanding.
On July 21, 2010, the Company entered into an “at the market” (ATM) equity offering sales agreement with McNicoll, Lewis & Vlak LLC, or MLV, pursuant to which it may issue and sell shares of its common stock from time to time through MLV acting as sales agent and underwriter. Sales of the Company’s common stock through MLV are made on the Company’s principal trading market by means of ordinary brokers’ transactions at market prices, in block transactions or as otherwise agreed by MLV and the Company. MLV uses its commercially reasonable efforts to sell the Company’s common stock from time to time, based upon instructions from the
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OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
Company (including any price, time or size limits the Company may impose). The Company pays MLV a commission rate of up to 7.0% of the gross sales price per share of any common stock sold through MLV as agent under the sales agreement. During the year ended December 31, 2011, the Company sold 7,793,000 shares of common stock pursuant to the ATM sales agreement resulting in net proceeds to the Company of approximately $17,146,000. As of December 31, 2011, the Company is not able to sell additional shares under this ATM due to SEC limitations on the number of shares issuable pursuant to a Form S-3 registration statement in a primary offering by smaller reporting companies such as the Company. The Company expects to be able to resume such sales in the second half of 2012, should it meet the issuance criteria of the SEC and NASDAQ.
In November 2011, OXiGENE entered into a purchase agreement for the sale, from time to time, of up to $20,000,000 of its common stock with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor. The proceeds from any sales under this purchase agreement will be used to further develop our late and early-stage clinical pipeline and to fund the Company’s ongoing operations. During the 36-month term of the purchase agreement, the Company controls the timing and amount of any sales to LPC, if and when it decides, in accordance with the purchase agreement. LPC has no right to require the Company to sell any shares to LPC, but LPC is obligated to make purchases as OXiGENE directs, subject to certain conditions, which include the continuing effectiveness of a registration statement filed with the U.S. Securities and Exchange Commission covering the resale of the shares that may be issued to LPC and limitations related to the market value of the Company’s common stock. There is no guarantee that funding from LPC will be available when needed, or at all, or that the Company will be able to maintain effectiveness of the aforementioned registration statement. There are no upper limits to the price LPC may pay to purchase the Company’s common stock and the purchase price of the shares related to any future sales will be based on the prevailing market prices of the Company’s shares immediately preceding the notice of sale to LPC without any fixed discount. The agreement may be terminated by OXiGENE at any time, at its sole discretion, without any cost or penalty. In connection with the LPC agreement, the Company issued approximately 300,000 shares of common stock as its initial commitment fee.
Reverse Stock Split
In February 2011, the Company’s board of directors voted unanimously to implement a 1:20 reverse stock split of the Company’s common stock, following authorization of the reverse split by a shareholder vote on December 21, 2010. The reverse split became effective on February 22, 2011. All of the share and per share values discussed and shown in the consolidated financial statements prior to this date have been adjusted to reflect the effect of this reverse stock split.
Warrant Exchange Agreements
On January 18, 2011, OXiGENE entered into separate Warrant Exchange Agreements (Private Placement Warrant Exchange) with each of the holders of Series A and Series C warrants to purchase shares of common stock, issued in March 2010, pursuant to which, at the initial closing, the warrant holders exchanged their outstanding Series A and Series C warrants having “ratchet” price-based anti-dilution protections for (A) an aggregate of 1,096,933 shares of common stock and (B) Series E Warrants to purchase an aggregate of 1,222,623 shares of common stock. The Series E Warrants were not exercisable for nine months, had an exercise price of $4.60 per share (reflecting the market value of the shares of common stock as of the close of trading on January 18, 2011, prior to the entry into the Warrant Exchange Agreements), and did not contain any price-based anti-dilution protections. In addition, the Company agreed to seek shareholder approval to issue, in exchange for the Series E Warrants, up to 457,544 additional shares of common stock to the warrant holders in a subsequent closing. The initial closing occurred on January 20, 2011, and the subsequent closing took place on March 21, 2011, following a stockholder meeting on March 18, 2011. As a result, there were no Series A, Series C or Series E warrants outstanding as of the subsequent closing date nor for any period thereafter. Similar to the Series A and Series C warrants, the Series E Warrants were classified as a liability during the period that they were outstanding.
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Table of Contents
OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
In connection with the warrant exchange, the Company also amended its Stockholder Rights Agreement with American Stock Transfer & Trust Company, LLC, dated as of March 24, 2005, as amended as of October 1, 2008, October 14, 2009 and March 10, 2010, to provide that the provisions of the Stockholder Rights Agreement shall not apply to the transactions contemplated by the Warrant Exchange Agreements. Refer to Private Issuance of Public Equity “PIPE” Warrants below for further discussion of this exchange.
Warrants, Options, Non-Vested Stock, 2009 ESPP and Director Compensation Policy
Warrants
The following is a summary of the Company’s Derivative liability activity for the year ended December 31, 2011 (in 000’s):
Derivative liability outstanding at December 31, 2010 | $ | 7,611 | ||
Impact of warrant exchange agreements | (6,071 | ) | ||
CEFF warrants — amounts reclassified to equity | (3 | ) | ||
Net decrease in fair value of all warrants | (1,531 | ) | ||
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Derivative liability outstanding at December 31, 2011 | $ | 6 | ||
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The table below summarizes the value (in thousands) of the warrant-related liabilities recorded on the Company’s balance sheet:
Warrants Issued in Connection with: | As of December 31, 2011 | As of December 31, 2010 | ||||||
| Long-term | Long-term | |||||||
Committed Equity Financing Facility | $ | — | $ | 6 | ||||
Direct Registration Series I Warrants | 6 | 107 | ||||||
Private Placement Series A Warrants | — | 4,143 | ||||||
Private Placement Series C Warrants | — | 3,355 | ||||||
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Total derivative liability | $ | 6 | $ | 7,611 | ||||
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The gain (loss) from the change in fair value of warrants and other financial instruments for the years ended December 31, 2011, 2010 and 2009 is summarized below (in thousands):
| 2011 | 2010 | 2009 | ||||||||||
Symphony Additional Investment Shares | $ | — | $ | — | $ | 416 | ||||||
Committed Equity Financing Facility Warrants | 3 | 96 | (105 | ) | ||||||||
Direct Registration Warrants | 102 | 2,093 | 1,855 | |||||||||
Excess of value of the Private Placement Warrants at issuance over | — | (4,933 | ) | — | ||||||||
Gain recognized in connection with warrant exchange agreements | 690 | — | — | |||||||||
Private Placement Warrants | 1,427 | (3,274 | ) | — | ||||||||
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Total gain (loss) on change in fair market value of derivatives | $ | 2,222 | $ | (6,018 | ) | $ | 2,166 | |||||
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OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
The following is a summary of the Company’s outstanding common stock warrants as of December 31, 2011 and 2010:
Warrants Issued in Connection with: | Date of Issue | Average Exercise Price | Number of Warrants outstanding as of: (in thousands) | |||||||||||
| December 31, 2011 | December 31, 2010 | |||||||||||||
Committed Equity Financing Facility | February 19, 2008 | $ | 54.80 | 13 | 13 | |||||||||
Direct Registration Series I Warrants | July 20, 2009 | $ | 42.00 | 141 | 141 | |||||||||
Private Placement Series A Warrants | March 11, 2010 | $ | 5.60 | — | 1,536 | |||||||||
Private Placement Series C Warrants | March 11, 2010 | $ | 5.60 | — | 1,229 | |||||||||
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Total Warrants outstanding | 154 | 2,919 | ||||||||||||
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As of December 31, 2010, the Committed Equity Financing Facility warrants were accounted for as a liability. Effective with the Warrant Exchange described above, these warrants have been reclassified as equity.
Private Issuance of Public Equity “PIPE” Warrants
On March 11, 2010, the Company completed a definitive agreement with certain institutional investors to sell shares of its common stock and four separate series of warrants to purchase common stock in a private placement. Gross proceeds of the financing were approximately $7,500,000, before deducting placement agent fees and estimated offering expenses, and excluding the subsequent exercises of the warrants.
The four separate series of warrants consisted of the following:
(A) Series A Warrants to initially purchase 328,947 shares of common stock, which were exercisable immediately after issuance, had a 5-year term and had an initial per share exercise price of $30.40;
(B) Series B Warrants to initially purchase 328,947 shares of common stock, which were initially exercisable at a per share exercise price of $22.80, on the earlier of the six month anniversary of the closing date or the date on which the Company’s stockholders approved the issuance of shares in the transaction, and expired on the later of three months from the effective date of the resale registration statement covering such shares and seven months from the closing date. These warrants expired on October 12, 2010;
(C) Series C Warrants to initially purchase 328,947 shares of common stock, and which would be exercisable upon the exercise of the Series B Warrants and on the earlier of the six month anniversary of the closing date or the date on which the Company’s stockholders approved the issuance of shares in the transaction, would expire five years after the date on which they become exercisable, and had an initial per share exercise price of $22.80; and
(D) Series D Warrants to purchase shares of common stock. The Series D Warrants were not immediately exercisable. The Company registered for resale 337,757 shares of common stock issuable upon exercise of the Series D Warrants pursuant to an agreement with the warrant holders. All of the Series D Warrants were exercised by November 4, 2010 and there are no Series D Warrants outstanding after that date.
The Series A, B and C warrants listed above contained full ratchet anti-dilution features based on the price and terms of any financings completed after March 11, 2010 as described in the warrant agreements. All of the warrants listed above contained a cashless exercise feature as described in the warrant agreements.
The Company determined that in accordance with Accounting Standards Codification (ASC) 480,Distinguishing Liabilities from Equity, the Series A, B, and C warrants qualify for treatment as liabilities due to provisions of the related warrant agreements that call for the number of warrants and their exercise price to be adjusted in the event that the Company issues additional shares of common stock, options or convertible instruments at a price that is less than the initial exercise price of the warrants. The Company also determined
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Table of Contents
OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
that, in accordance with ASC 815,Derivatives and Hedging, the Series D Warrants meet the definition of a derivative. The issuance date fair market value of the Series A, B, C and D warrants of $11,868,000 was recorded as a liability. The approximately $4,933,000 excess of the fair value of the liability recorded for these warrants over the net proceeds received was recorded as a charge to earnings and is included in “Change in fair value of warrants and other financial instruments” within the Statement of Operations. Changes in the fair market value from the date of issuance to the exercise date and reporting date, until exercised or cancelled will be recorded as a gain or loss in the statement of operations.
As of December 31, 2010, all Series B and D warrants had either been exercised or expired.
On January 18, 2011, OXiGENE entered into separate Warrant Exchange Agreements with each of the holders of Series A and Series C warrants to purchase shares of common stock, issued in March 2010, pursuant to which, at the initial closing, the warrant holders exchanged their outstanding Series A and Series C warrants having “ratchet” price-based anti-dilution protections for (A) an aggregate of 1,096,933 shares of common stock and (B) Series E Warrants to purchase an aggregate of 1,222,623 shares of common stock. The Series E Warrants were not exercisable for six months, had an exercise price of $4.60 per share (reflecting the market value of the shares of common stock as of the close of trading on January 18, 2011, prior to the entry into the Warrant Exchange Agreements), and did not contain any price-based anti-dilution protections. In addition, the Company agreed to seek shareholder approval to issue, in exchange for the Series E Warrants, up to 457,544 additional shares of common stock to the warrant holders in a subsequent closing. The Series E Warrants were accounted for as a liability from the date of issuance to the date of exchange, all of which occurred during the first quarter of fiscal 2011. The initial closing occurred on January 20, 2011, and the subsequent closing took place on March 21, 2011, following the stockholder meeting on March 18, 2011. The Company determined that in accordance with Accounting Standards Codification (ASC) 480,Distinguishing Liabilities from Equity, the Series E warrants qualify for treatment as a liability during the period that they were outstanding due to provisions of the related warrant agreement that allow for the warrants to be net settled in shares of the Company’s common stock under certain circumstances as described in the agreement. As a result, there were no Series A, Series C or Series E warrants outstanding as of the subsequent closing date nor for any period thereafter. Similar to the Series A and Series C warrants, the Series E Warrants were classified as a liability during the period that they were outstanding.
On January 20, 2011, the date of the initial closing of the Warrant Exchange Agreements, the Company marked the existing Series A and C warrants to market at a combined fair value of $6,633,000. These warrants were exchanged for Series E warrants, valued at $1,555,000, and shares of common stock valued at $4,388,000. The difference between these items was recorded as a gain on the transaction of $690,000. On the date of the subsequent closing, the fair value of the Series E warrants was equal to the value of the 457,544 shares of common stock issued in the exchange, and therefore there was no gain or loss on this component of the transaction.
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OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
The table below summarizes the factors used to determine the value of the Series A and C warrants outstanding during the year ended December 31, 2011. The Company established the fair value of the Series A and C warrants using the Black-Scholes option valuation model:
| Warrant Valuation on date of Warrant Exchange January 19, 2011 | Total Fair Market Value | |||||||||||
| Series A | Series C | |||||||||||
Stock Price | $ | 4.32 | $ | 4.32 | ||||||||
Exercise Price | $ | 5.60 | $ | 5.60 | ||||||||
Contractual life (in Years) | 4.1 years | 4.5 years | ||||||||||
Expected volatility | 82 | % | 79 | % | ||||||||
Risk-free interest rate | 1.53 | % | 1.68 | % | ||||||||
Fair market value (in thousands) | $ | 3,663 | $ | 2,970 | $ | 6,633 | ||||||
| Warrant Valuation as of December 31, 2010 | Total Fair Market Value | |||||||||||
| Series A | Series C | |||||||||||
Stock Price | $ | 4.60 | $ | 4.60 | ||||||||
Exercise Price | $ | 5.60 | $ | 5.60 | ||||||||
Contractual life (in Years) | 4.2 years | 4.5 years | ||||||||||
Expected volatility | 81 | % | 80 | % | ||||||||
Risk-free interest rate | 2.01 | % | 2.01 | % | ||||||||
Fair market value (in thousands) | $ | 4,143 | $ | 3,355 | $ | 7,498 | ||||||
Management determined the fair value of the Series E Warrants on the date of the initial closing to be $1,555,000. This fair value was estimated based upon the $4.00 per share fair value of the 457,544 shares of common stock expected to be exchanged for the Series E Warrants upon shareholder approval adjusted for a 15% discount for lack of marketability which existed until the expected shareholder vote. Management determined the fair value of the Series E warrants on the date of the subsequent closing to be $993,000. This fair value was estimated based upon the $2.17 per share fair value of the 457,544 shares of common stock exchanged for the Series E Warrants.
Committed Equity Financing Facility (“CEFF”) with Kingsbridge Capital Limited
In February 2008, OXiGENE entered into a Committed Equity Financing Facility (“CEFF”) with Kingsbridge Capital Limited (“Kingsbridge”), which was subsequently amended in February 2010 to increase the commitment period, increase the draw down discount price and increase the maximum draw period. Effective October 14, 2011, the CEFF was terminated by the Company.
Under the terms of the amended CEFF, Kingsbridge committed to purchase, subject to certain conditions, up to 285,401 shares of the Company’s common stock during the period ending May 15, 2012. While the CEFF was effective, OXiGENE was able to draw down in tranches at discounts as described in detail in the common stock purchase agreement. In connection with the CEFF, the Company issued a warrant to Kingsbridge to purchase 12,500 shares of its common stock at a price of $54.80 per share exercisable beginning six months after February 19, 2008 and for a period of five years thereafter. The CEFF was terminated during 2011. As a result, shares of the Company’s common stock are no longer available for sale under this facility.
Due to the initially indeterminate number of shares of common stock underlying the warrants issued in connection with the Company’s private placement on March 11, 2010, OXiGENE concluded that the CEFF warrants should be recorded as a liability effective with the date of the private placement. The fair value of the
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OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
warrants on this date was reclassified from equity to derivative liabilities. Changes in the fair market value from the date of the private placement to the reporting date were recorded as a gain or loss in “Change in fair value of warrants and other financial instruments” in the Statement of Operations. Effective with the warrant exchange agreements executed in January 2011 as described above, the number of shares underlying the warrants issued in connection with the Company’s private placement was no longer indeterminable, and the CEFF warrants were reclassified to equity. The Company revalued these warrants on the effective date of the exchange and recorded the gain in the Statement of Operations. The Company established the fair value of the CEFF warrants using the Black-Scholes option valuation model as reflected in the table below:
| Warrant Valuation as of: | ||||||||
| Date of Warrant Exchange January 19, 2011 | December 31, 2010 | |||||||
Stock Price | $ | 4.32 | $ | 4.60 | ||||
Exercise Price | $ | 54.80 | $ | 54.80 | ||||
Contractual life (in Years) | 2.6 years | 2.6 years | ||||||
Expected volatility | 87 | % | 96 | % | ||||
Risk-free interest rate | 0.82 | % | 1.02 | % | ||||
Fair market value (in thousands) | $ | 3 | $ | 6 | ||||
Direct Registration Warrants
On July 20, 2009, OXiGENE raised approximately $10,000,000 in gross proceeds, before deducting placement agents’ fees and other offering expenses, in a registered direct offering (the “Offering”) relating to the sale of 312,500 units, each unit consisting of (i) one share of common stock, (ii) a five-year warrant (“Direct Registration Series I”) to purchase 0.45 shares of common stock at an exercise price of $42.00 per share of common stock and (iii) a short-term warrant (“Direct Registration Series II”) to purchase 0.45 shares of common stock at an exercise price of $32.00 per share of common stock (the “Units”). The short-term warrants expired on September 24, 2010 consistent with the terms of the warrant, without being exercised.
OXiGENE determined that the Direct Registration Series I warrants should be classified as a liability as they require delivery of registered shares of common stock and thus could require net-cash settlement in certain circumstances. Accordingly, these warrants were recorded as a liability at their fair value as of the date of their issuance and are revalued at each subsequent reporting date.
The fair value of the direct registration warrants was determined using the Black-Scholes option valuation model applying the following assumptions:
| Series I Warrant Valuation as of: | ||||||||
| December 31, 2011 Series I | December 31, 2010 Series I | |||||||
Stock Price | $ | 0.99 | $ | 4.60 | ||||
Exercise Price | $ | 42.00 | $ | 42.00 | ||||
Contractual life (in Years) | 2.6 years | 3.6 years | ||||||
Expected volatility | 107 | % | 86 | % | ||||
Risk-free interest rate | 0.36 | % | 1.02 | % | ||||
Fair market value (in thousands) | $ | 6 | $ | 107 | ||||
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Options
The Company’s 2005 Stock Plan, as amended at the 2011 Annual Meeting of Stockholders in October 2011 (the “2005 Plan”) provides for the award of options, restricted stock and stock appreciation rights to acquire up to
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OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
2,500,000 shares of the Company’s common stock in the aggregate. This number includes shares of its common stock, if any, that were subject to awards under the Company’s 1996 Stock Incentive Plan (the “1996 Plan”) as of the date of adoption of the 2005 Plan but which were returned or will be returned to the 2005 Plan upon the cancellation, surrender or termination of such award. Currently, the 2005 Plan allows for awards of up to 200,000 shares that may be granted to any one participant in any fiscal year. For options subject to graded vesting, the Company elected the straight-line method of expensing these awards over the service period.
The following is a summary of the Company’s stock option activity under its 1996 Plan and 2005 Plan for the year ended December 31, 2011:
| Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life | Aggregate Intrinsic Value | |||||||||||||
| (In thousands) | (Years) | (In thousands) | ||||||||||||||
Options outstanding at December 31, 2010 | 326 | $ | 28.49 | 8.63 | ||||||||||||
Granted | 843 | $ | 1.05 | |||||||||||||
Exercised | — | $ | — | $ | — | |||||||||||
Forfeited and expired | (167 | ) | $ | 25.37 | ||||||||||||
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Options outstanding at December 31, 2011 | 1,002 | $ | 5.91 | 9.26 | ||||||||||||
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Options exercisable at December 31, 2011 | 347 | $ | 11.90 | 8.24 | ||||||||||||
Options vested or expected to vest at December 31, 2011 | 717 | $ | 7.26 | 9.04 | $ | — | ||||||||||
During the year ended December 31, 2011, 29,900 options expired. As of December 31, 2011 there was approximately $475,800 of unrecognized compensation cost related to stock option awards that is expected to be recognized as expense over a weighted average period of approximately 2 years.
The following stock options were granted during the years ended December 31, 2011, 2009 and 2008:
| 2011 | 2010 | 2009 | ||||||||||
Options Granted (In thousands) | 843 | 257 | 73 | |||||||||
Weighted average fair value | $ | 0.62 | $ | 0.45 | $ | 0.59 | ||||||
The fair values for the stock options granted were estimated at the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions for the three years ended December 31, 2011, 2010 and 2009:
| Weighted Average Assumptions | 2011 | 2010 | 2009 | |||||||||
Risk-free interest rate | 0.26 | % | 1.83 | % | 1.99 | % | ||||||
Expected life | 2 years | 4 years | 5 years | |||||||||
Expected volatility | 112 | % | 70 | % | 58 | % | ||||||
Dividend yield | 0.00 | % | 0.00 | % | 0.00 | % | ||||||
In calculating the estimated fair value of its stock options, the Company used the Black-Scholes option pricing model which requires the consideration of the following six variables for purposes of estimating fair value:
| Ÿ | the stock option exercise price, |
| Ÿ | the expected term of the option, |
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OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
| Ÿ | the grant date price of OXiGENE’s common stock, which is issuable upon exercise of the option, |
| Ÿ | the expected volatility of OXiGENE’s common stock, |
| Ÿ | the expected dividends on OXiGENE’s common stock (the Company does not anticipate paying dividends in the foreseeable future), and |
| Ÿ | the risk free interest rate for the expected option term. |
Stock Option Exercise Price and Grant Date Price of OXiGENE’s common stock — The closing market price of its common stock on the date of grant.
Expected Term — The expected term of options represents the period of time for which the options are expected to be outstanding and is based on an analysis of historical behavior of participants over time.
Expected Volatility — The expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate during the term of the option granted. OXiGENE determines the expected volatility based on the historical volatility of its common stock over a period commensurate with the option’s expected term.
Expected Dividends — Because OXiGENE has never declared or paid any cash dividends on any of its common stock and does not expect to do so in the foreseeable future, the Company uses an expected dividend yield of zero to calculate the grant date fair value of a stock option.
Risk-Free Interest Rate — The risk-free interest rate is the implied yield available on U.S. Treasury issues with a remaining life consistent with the option’s expected term on the date of grant.
The Company is required to estimate the level of award forfeitures expected to occur and record compensation expense only for those awards that are ultimately expected to vest. This requirement applies to all awards that are not yet vested, including awards granted prior to January 1, 2006. Accordingly, OXiGENE performed a historical analysis of option awards that were forfeited prior to vesting, and ultimately recorded total stock option expense that reflected this estimated forfeiture rate. In the Company’s calculation, it segregated participants into two distinct groups, (1) directors and officers and (2) employees, and OXiGENE’s estimated forfeiture rates were calculated at 25% and 50%, respectively using the straight line method. This analysis will be re-evaluated quarterly and the forfeiture rate will be adjusted as necessary.
Non-Vested Restricted Stock
As of December 31, 2010, the Company had 1,000 shares of non-vested restricted common stock outstanding related to grants of restricted common stock in June 2007. During fiscal 2011, 500 of those shares vested with the remaining 500 shares being forfeited, such that as of December 31, 2011, the Company did not have any non-vested restricted common stock outstanding.
The Company recorded expense of approximately $20,000, $82,000 and $242,000 related to outstanding restricted stock awards during the years ended December 31, 2011, 2010 and 2009, respectively. The restricted stock awards were valued based on the closing price of the Company’s common stock on their respective grant dates. Compensation expense was recognized on a straight -line basis over the 4 year vesting period of the awards.
Employee Stock Purchase Plan (2009 ESPP)
Under the 2009 Employee Stock Purchase Plan (the “2009 ESPP”), employees have the option to purchase shares of the Company’s common stock at 85% of the closing price on the first day of each purchase period or the last day of each purchase period (as defined in the 2009 ESPP), whichever is lower, up to specified limits. Eligible employees are given the option to purchase shares of the Company’s common stock, on a tax-favored
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OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
basis, through regular payroll deductions in compliance with Section 423 of the Internal Revenue Code of 1986, as amended (the “Code”). Currently, an aggregate of 125,000 shares of common stock may be issued under the 2009 ESPP, subject to adjustment each year pursuant to the terms of the 2009 ESPP.
The Company recorded expense relating to the 2009 ESPP for the years ended December 31, 2011, 2010 and 2009 of approximately $2,000, $8,000 and $50,000, respectively. Pursuant to the 2009 ESPP provisions, each year beginning in 2010 there will be an annual increase in the number of shares available for issuance under the ESPP on the first day of the new year in an amount equal to the lesser of: 25,000 shares or 5% of the shares of Common Stock outstanding on the last day of the preceding fiscal year.
Director Compensation Policy
In December 2009, the board of directors approved a policy which established compensation to be paid to non- employee directors of the Company, to provide an inducement to obtain and retain the services of qualified persons to serve as members of the board of directors. In September 2011, the board of directors approved an amendment and restatement of the policy (the “Amended and Restated Director Compensation Policy”). The Amended and Restated Director Compensation Policy provides for annual compensation of $80,000 in cash/equity value to each non-employee director payable in two payments of $40,000 in cash/equity value, on January 2 and July 1. Each non-employee director may elect to receive such compensation in a combination of fully vested options and/or stock and up to 50% of the total compensation in cash. Prior to the September 2011 amendment, each of the Company’s non-employee directors were granted 1,250 fully vested shares of common stock on both January 2 and July 1 of each year they were a director.
The Company recorded total expense of approximately $284,000, $420,000 and $554,000 during the years ended December 31, 2011, 2010 and 2009, respectively, for director compensation consistent with the policy described above, of which approximately $108,000, $325,000 and $321,000 represented the stock-based component of the expense for the years ended December 31, 2011, 2010 and 2009, respectively.
7. Symphony Transaction
On October 1, 2008, OXiGENE announced a strategic collaboration with Symphony Capital Partners, L.P. a private-equity firm that agreed to provide funding to support the advancement of ZYBRESTAT for oncology, ZYBRESTAT for ophthalmology and OXi4503. Under this collaboration, the Company entered into a series of related agreements with Symphony Capital LLC, or Symphony, Symphony ViDA, Inc., or ViDA, Symphony ViDA Holdings LLC, or Holdings, and related entities.
Pursuant to these agreements, Holdings had formed and capitalized ViDA, a Delaware corporation, in order (a) to hold certain intellectual property related to two of OXiGENE’s product candidates, ZYBRESTAT for use in ophthalmologic indications and OXi4503, referred to as the “Programs,” which were exclusively licensed to ViDA under the Novated and Restated Technology License Agreement and (b) to fund commitments of up to $25,000,000. The funding supported pre-clinical and clinical development by OXiGENE, on behalf of ViDA, for the Programs.
As part of a series of related agreements with Holdings, on October 1, 2008, Holdings purchased $15,000,000 worth of shares of common stock at a price of $22.20 per share, which was equal to the closing price of the Company’s common stock on September 30, 2008, via a direct investment.
On July 2, 2009, the Company, Holdings and ViDA entered into a series of related agreements pursuant to which such parties agreed to amend the terms of the purchase option, as set forth in an amended and restated purchase option agreement (the “Amended Purchase Option Agreement”). In connection with such amendment, OXiGENE and Holdings also entered into an amended and restated registration rights agreement.
Under the Amended Purchase Option Agreement, OXiGENE issued 500,000 newly-issued shares of OXiGENE common stock in exchange for all of the equity of ViDA which included further consideration for
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OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
additional securities issued in connection with the July 2009 Registered Direct Offering. The Company re-acquired all of the rights to the Programs that had been licensed in 2008 to ViDA. In addition, the approximately $12,400,000 in cash and marketable securities held by ViDA was transferred to OXiGENE.
OXiGENE recorded the acquisition of ViDA as a capital transaction and the $10,383,000 excess of the fair market value of the common shares issued by OXiGENE ($15,600,000) over the carrying value of the noncontrolling interest ($5,217,000) was reflected directly in equity as a reduction to Additional paid-in capital. As a result, the noncontrolling interest balance was eliminated. The reduction to Additional paid-in capital was also presented as an increase in the loss applicable to common stock within the calculation of basic and diluted earnings per share.
OXiGENE consolidated the financial position and results of operations of Symphony ViDA, Inc. from October 2008, when it entered into a strategic collaboration with Symphony ViDA Holdings, LLC, until July 20, 2009 when OXiGENE acquired 100% of ViDA pursuant to the Amended Purchase Option Agreement. The funding supported pre-clinical and clinical development by OXiGENE, on behalf of ViDA, for ZYBRESTAT for ophthalmology and OXi4503.
8. Net Loss Per Share
Basic and diluted net loss per share was calculated by dividing the net loss per share attributed to OXIGENE common shares by the weighted-average number of common shares outstanding. Diluted net loss per share includes the effect of all dilutive, potentially issuable common equivalent shares as defined using the treasury stock method. All of the Company’s common stock equivalents are anti-dilutive due to the Company’s net loss position for all periods presented. Accordingly, common stock equivalents of approximately 1,154,000, 3,354,000 and 391,000 at December 31, 2011, 2010 and 2009, respectively, were excluded from the calculation of weighted average shares for diluted net loss per share.
During 2009, the Company recorded the excess of the purchase price over the carrying value of the noncontrolling interest in ViDA as an increase in the loss applicable to common stock (SeeSymphony Transactionabove).
Comprehensive (Loss)
ASC 220, Comprehensive Income, establishes rules for the reporting and display of comprehensive loss and its components and requires unrealized gains or losses on the Company’s available-for-sale securities and the foreign currency translation adjustments to be included in other comprehensive loss. Comprehensive loss was the same as the reported net loss for the years ended December 31, 2011 and 2010.
A reconciliation of comprehensive loss for the year ended December 31, 2009 is as follows (in thousands):
Consolidated net loss as reported | $ | (28,943 | ) | |
Unrealized gains | 110 | |||
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Total comprehensive income (loss) | (28,833 | ) | ||
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Less comprehensive loss attributable to noncontrolling interest | (4,215 | ) | ||
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Comprehensive loss attributable to OXiGENE, Inc. | $ | (24,618 | ) | |
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9. Agreements
In April 2009, the Company entered into a separation agreement with Patricia Walicke, M.D., Ph.D., its former Vice President and Chief Medical Officer. Pursuant to the separation agreement, Dr. Walicke, received severance payments in the amount of $300,000 made in equal installments over one year. All unvested options held by Dr. Walicke were forfeited as of July 29, 2009 and no further severance payments are required.
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OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
In October 2009, the Board of Directors accepted the resignation of John A. Kollins as Chief Executive Officer and as a member of the Board of Directors. The Company entered into a separation agreement with Mr. Kollins effective as of November 5, 2009. Mr. Kollins received his base salary of $350,000 made in equal installments for one year plus health benefits for up to 2 years, and a one time $20,000 payment. All unvested options held by Mr. Kollins were forfeited as of January 8, 2010.
In September 2011, the Company entered into a separation agreement with David Chaplin, Ph.D., its former Vice President and Chief Scientific Officer, following the Company’s restructuring described in Note 4 above. Pursuant to the separation agreement, Dr. Chaplin, is receiving severance payments in the amount of approximately $395,000 made in equal installments over sixteen months. All unvested options held by Dr. Chaplin were forfeited as of September 1, 2011.
On September 1, 2011, the Company determined that the employment of James Murphy as the Company’s Vice President and Chief Financial Officer would end on October 31, 2011 following the Company’s September 2011 restructuring described in Note 4 above. Mr. Murphy continues to serve as the Company’s Vice President and Chief Financial Officer on a temporary basis until his replacement is hired. In December 2011, the Company entered into a separation agreement with Mr. Murphy. Pursuant to the separation agreement, Mr. Murphy received a one-time severance payment in the amount of $245,000. In addition, the Company will pay for health benefits for 1 year. All unvested options held by Mr. Murphy were forfeited as of September 1, 2011.
10. Income Taxes
The components of the Company’s deferred tax assets at December 31, 2011 and 2010 are as follows: (Amounts in thousands)
| 2011 | 2010 | |||||||
Deferred Tax Assets: | ||||||||
Net operating loss carry-forwards | $ | 71,405 | $ | 74,444 | ||||
Stock-based awards | 164 | 324 | ||||||
Research & development credits | 2,784 | 2,444 | ||||||
Capital loss carryforward | 1,490 | 1,575 | ||||||
Other | 291 | 201 | ||||||
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Total Deferred tax assets | 76,134 | 78,988 | ||||||
Valuation allowance | (76,134 | ) | (78,988 | ) | ||||
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Net deferred tax asset | $ | — | $ | — | ||||
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After consideration of the available evidence, both positive and negative, the Company has determined that a full valuation allowance at December 31, 2011 and 2010, is necessary to reduce the deferred tax assets to the amount that will more likely than not be realized. The valuation allowance decreased by approximately $2,854,000 and increased by approximately $5,640,000 for the years ended December 31, 2011 and 2010, respectively, due primarily to changes in federal and state net operating loss carry-forwards.
At December 31, 2011, the Company had net operating loss carry-forwards of approximately $197,097,000 for U.S. income tax purposes, which began to expire during 2011 and state operating loss carry-forwards of $48,502,000 in Massachusetts that begin expiring in 2012 and $31,392,000 in California that begin to expire in 2027. The Company also had tax credits of $3,080,000 related to federal and state research and development activities which begin to expire in 2021. The Company recorded a capital loss carryover of approximately $4,000,000 in 2009 that generated a deferred tax asset of $1,490,000.
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OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
The future utilization of the net operating loss carry-forwards and credit carry-forwards may be subject to an annual limitation due to ownership changes that could have occurred in the past or that may occur in the future under the provisions of IRC Section 382 or 383 of the internal revenue code.
The Company has not, as yet, conducted a study of its research and development credit carry-forwards. This study may result in an adjustment to the Company’s research and development credit carry-forwards, however, until a study is completed and any adjustment is known, no amounts are presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credits and if an adjustment is required, this adjustment would be offset by any adjustment to the deferred tax asset established for the research and development credit carry-forward and the valuation allowance.
In 2010, the Company received $733,000 in tax credit grants under the U.S. Government’s Qualifying Therapeutic Discovery Project for qualified research and development expenses. These proceeds have been recognized as other income.
The Company provides for income taxes under the liability method in accordance with the FASB’s guidance on accounting for income taxes. As all of the Company’s deferred tax assets have been reserved for in a valuation allowance, no provision for (benefit from) income taxes have been recorded in the accompanying consolidated financial statements.
A reconciliation of the federal statutory rate to the Company’s effective tax rate is as follows:
| Years ended December 31, | ||||||||
| 2011 | 2010 | |||||||
Income tax benefit at federal statutory rate | 34.0 | % | 34.0 | % | ||||
Increase (decrease) in tax resulting from: | ||||||||
State income taxes | 4.9 | 3.6 | ||||||
State rate change | (0.3 | ) | (1.6 | ) | ||||
Federal research credits | 2.4 | 1.2 | ||||||
Warrants | 7.8 | (8.6 | ) | |||||
Federal Net Operating Loss adjustment | (59.9 | ) | 6.7 | |||||
State Net Operating Loss expired and adjusted | (14.1 | ) | (6.9 | ) | ||||
Stock Compensation Adjustment | (4.3 | ) | (4.1 | ) | ||||
Permanent items | (0.1 | ) | (0.6 | ) | ||||
Change In Valuation Allowance | 29.6 | (23.7 | ) | |||||
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Provision for income taxes | — | % | — | % | ||||
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The provisions of FIN 48 (as codified under ASC 740), were adopted by the Company on January 1, 2007. ASC 740 clarifies the accounting for income taxes, by prescribing a minimum recognition threshold that a tax position is required to meet before being recognized in the financial statements. ASC 740 also provides guidance on de-recognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. The implementation of ASC 740 did not have a material impact on the Company’s financial position, cash flows or results of operations. At December 31, 2011 and 2010, the Company had no unrecognized tax benefits.
There are currently no federal or state audits in progress, tax years still subject to examination for Federal and the State of Massachusetts and California authorities include all prior years due to the existence of net operating loss carry-forwards. However, the statute of limitation for assessment by the internal revenue service and state authorities is only open for tax years ended December 31, 2008, 2009 and 2010.
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OXiGENE, INC.
Notes to Consolidated Financial Statements — (Continued)
11. Commitments and Contingencies
Leases
In November 2008, the Company executed a lease for a total of approximately 12,300 square feet of office space located in South San Francisco, California. The lease agreement is for an estimated 52 months. In May 2010, the Company executed a lease for approximately 3,900 square feet in Waltham, Massachusetts.
During 2009 and for the first five months of 2010, the Company occupied approximately 11,000 square feet in Waltham, Massachusetts. In June of 2010, the Company executed a lease for a total of approximately 3,000 square feet of office space located in Waltham, Massachusetts. The lease in Waltham expires at the end of May 2012 and is not expected to be renewed. During 2009 and for the first five months of 2010, the Company occupied approximately 600 square feet in Oxford, UK.
The following table summarizes the rent expense by location for the years ended December 31, 2011, 2010 and 2009 (Amounts in thousands)
| 2011 | 2010 | 2009 | ||||||||||
California | $ | 507 | $ | 512 | $ | 442 | ||||||
Massachusetts | 76 | 76 | 170 | |||||||||
Oxford, UK | — | 18 | 50 | |||||||||
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Total rent | $ | 583 | $ | 606 | $ | 662 | ||||||
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The minimum annual rent commitments for the above leases are as follows: (Amounts in thousands)
| 2012 | 2013 | 2014 | 2015 | Thereafter | Total | |||||||||||||||||||
Gross Committements | $ | 549 | $ | 135 | $ | — | $ | — | $ | — | $ | 684 | ||||||||||||
12. Retirement Savings Plan
The Company sponsors a savings plan available to all domestic employees, which qualifies under Section 401(k) of the Internal Revenue Code. Employees may contribute to the plan from 1% to 20% of their pre-tax salary subject to statutory limitations. Annually the Board of Directors determines the amount, if any, of a Company match. The Company has not provided a match for the years ended December 31, 2011, 2010 or 2009.
13. Subsequent Events
Activity Under the Lincoln Park Capital Fund Share Purchase Arrangement
Subsequent to December 31, 2011, the Company has sold approximately 954,000 shares of its common stock under the Lincoln Park Share Purchase Agreement (LPC) as described in Note 6, for net proceeds of $1,000,000. In addition, the Company issued approximately 30,000 shares to LPC in lieu of a cash fee.
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