UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
| x | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2014
OR
| ¨ | 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 | 94080 | |
| South San Francisco, CA | (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 $.01 per share | The NASDAQ Stock Market LLC |
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ¨ No x
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ¨ No x
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 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. x
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 x | |||
| (Do not check if a smaller reporting company) | ||||||
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
The aggregate market value of the registrant’s 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, 2014 was $53,551,000.
As of March 25, 2015, the aggregate number of outstanding shares of common stock of the registrant was 26,544,934.
DOCUMENTS INCORPORATED BY REFERENCE
Certain portions of the registrant’s definitive Proxy Statement for the 2015 Annual Meeting of Stockholders to be held on May 28, 2015 are incorporated by reference into Items 10, 11, 12, 13 and 14 of Part III of this Annual Report on Form 10-K.
SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS
UNDER THE SECURITIES LITIGATION REFORM ACT OF 1995
This Annual Report on Form 10-K (“Annual Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, that involve substantial risks and uncertainties. We generally identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “indicate,” or “continue” or the negative of these terms or other similar words, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future, such as our estimates regarding anticipated operating losses, future performance, future revenues and projected expenses; our liquidity and our expectations regarding our needs for and ability to raise additional capital; our ability to manage our expenses effectively and raise the funds needed to continue our business; our ability to retain the services of our current executive officers, directors and principal consultants; the competitive nature of our industry and the possibility that our products or product candidates may become obsolete; our ability to obtain and maintain regulatory approval of our existing products and any future products we may develop; our ability to expand our commercial operations; the clinical development of and the process of commercializing fosbretabulin tromethamine; the combination of fosbretabulin tromethamine with AVASTIN ® (bevacizumab), the clinical development of and the process of commercializing OXi4503, the initiation, timing, progress and results of our preclinical and clinical trials, research and development programs; regulatory and legislative developments in the United States and foreign countries; the timing, costs and other limitations involved in obtaining regulatory approval for any product; the further preclinical or clinical development and commercialization of our product candidates; the potential benefits of our product candidates over other therapies; our ability to enter into any collaboration with respect to product candidates; our ability to continue to develop or commercialize our products or product candidates in the event any license agreements in place with third parties expire or are terminated; the performance of third parties, including our third-party manufacturers; our ability to obtain and maintain intellectual property protection for our products and operate our business without infringing upon the intellectual property rights of others; the potential liability exposure related to our products and our insurance coverage for such exposure; the successful development of our sales and marketing capabilities; the size and growth of the potential markets for our products and our ability to serve those markets; the rate and degree of market acceptance of any future products; the sufficiency of potential proceeds from the facility currently in place with MLV & Co. LLC (MLV); the tendency of our certificate of incorporation, amended and restated bylaws or our stockholders’ rights agreement to deter a change of management or delay acquisition offers; the volatility of the price of our common stock; our ability to maintain an effective system of internal controls; the payment and reimbursement methods used by private or governmental third-party payers; and other factors discussed elsewhere in this Annual Report or any document incorporated by reference herein or therein.
The words “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “indicate,” or “continue” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements contained in this Annual Report are based on our current expectations and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in the section titled “Risk Factors.” Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. “Risk Factors” and “Business,” as well as other sections in this Annual Report or incorporated by reference into this Annual Report, discuss some of the factors that could contribute to these differences.
The forward-looking statements made in this Annual Report relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events.
This Annual Report also contains market data related to our business and industry. These market data include projections that are based on a number of assumptions. While we believe these assumptions to be reasonable and sound as of the date of this Annual Report, if these assumptions turn out to be incorrect, actual results may differ from the projections based on these assumptions. As a result, our markets may not grow at the rates projected by these data, or at all. The failure of these markets to grow at these projected rates may have a material adverse effect on our business, results of operations, financial condition and the market price of our common stock.
i
| ITEM 1. | BUSINESS |
Our Business
Overview
We are a biopharmaceutical company primarily focused on the development of vascular disrupting agents, or VDAs, for the treatment of cancer. We have two clinical stage product candidates that are currently being developed in three potential oncology indications. Our lead compound, fosbretabulin tromethamine, or fosbretabulin, is being tested in two indications, recurrent ovarian cancer and gastrointestinal neuroendocrine tumors, or GI-NETs, and our second compound, OXi4503, is currently being tested in patients with relapsed or refractory acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS). We have been granted orphan drug designation for fosbretabulin in the treatment of ovarian cancer in the United States and the European Union, and for OXi4503 in the treatment of AML in the United States. To date, we have observed fosbretabulin to be well tolerated in over 450 patients and to have clinical activity in a variety of indications including ovarian cancer.
We are pursuing what we believe to be a cost-efficient, risk-mitigated development strategy. In the United States and Europe, we are pursuing collaborations with established pharmaceutical companies with products whose efficacy we believe can be enhanced by the addition of our lead product candidate, fosbretabulin, and with non-profit research organizations such as The Christie Hospital NHS Foundation Trust (UK), an international leader in cancer research and development, and the Gynecologic Oncology Group, or GOG, now part of NRG Oncology (NCI), an organization dedicated to clinical research in the field of gynecologic cancer, for the treatment of advanced ovarian cancer.
Fosbretabulin Development Program
Fosbretabulin is a reversible tubulin binding agent that selectively targets the endothelial cells that make up the blood vessel walls in most solid tumors and causes them to swell, obstructing the flow of blood and starving the tumor of vital nutrients including oxygen. This deprivation, also known as tumor hypoxia, results in rapid downstream tumor cell death.
Ovarian Cancer
Ovarian cancer affects approximately 22,000 women in the U.S. each year. This form of cancer begins in the ovaries and often spreads to the rest of the pelvis and abdomen prior to detection, resulting in a relatively poor prognosis. In fact, more than 60% of women diagnosed with ovarian cancer are in stage III or IV, making ovarian cancer difficult to treat and often fatal, with a five-year survival rate of approximately 45% — a rate which is largely unchanged since the 1990s. Overall, approximately 80% of patients diagnosed with ovarian epithelial, fallopian tube, and primary peritoneal cancer will relapse after first-line platinum-based and taxane-based chemotherapy. When treating recurrent ovarian cancer, the time between receiving the last dose of platinum-based chemotherapy and disease recurrence is used to help determine the choice of chemotherapy used in the next line of treatment. Patients are said to have ‘platinum-resistant’ disease if the disease worsens within six months of completing platinum-based chemotherapy. One quarter of those who relapse after initial treatment, or more than 4,300 women, will have platinum-resistant cancer, the most difficult-to-treat form of the disease. Additionally, a majority of patients who are not initially platinum-resistant and who may achieve a full remission following first-line therapy will also develop recurrent disease. There are relatively few cancer therapies that have been approved for the treatment of ovarian cancer including platinum-resistant cancer. Approved drugs include carboplatin and cisplatin, gemcitabine, doxorubicin, paclitaxel and bevacizumab. Many patients eventually become resistant to platinum-based therapies, and new treatment agents are needed. Due to the unmet need in the treatment of ovarian cancer and the small patient size of the indication in terms of number of patients, we have been granted an orphan drug designation in both the U.S. and Europe for the use of fosbretabulin in the treatment of ovarian cancer.
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Fosbretabulin in combination with AVASTIN ® (bevacizumab)—Completed Phase 2 Trial
Genentech / Roche’s AVASTIN ® (bevacizumab) is an anti-vascular endothelial growth factor, or VEGF, monoclonal antibody. We believe that using fosbretabulin in combination with AVASTIN ® (bevacizumab) may provide an equally effective yet potentially better tolerated alternative to the current standard of care, cytotoxic chemotherapy, for relapsed ovarian cancer. This belief is supported by the recently completed Phase 2 trial with this combination in recurrent ovarian cancer.
In November 2014, the positive study results from the Phase 2 GOG-0186I clinical trial were presented at the 15th Biennial International Gynecologic Cancer Society (IGCS) conference in Melbourne, Australia. The GOG-0186I clinical trial was conducted by the GOG, now part of NRG Oncology, under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) and was a randomized, two-arm Phase 2 trial evaluating AVASTIN ® (bevacizumab) alone, as compared to AVASTIN ® (bevacizumab) plus fosbretabulin, in patients with recurrent ovarian cancer. The trial enrolled a total of 107 patients with both platinum-sensitive and platinum-resistant recurrent ovarian cancer at 67 clinical sites in the United States. The results indicated a statistically significant increase in progression-free survival (PFS) in the combination arm, which was the primary endpoint of the trial, with a p-value of 0.049 (pre-specified analysis using a one-sided test; 10% level of significance). The hazard ratio was 0.685, with a 90% 2-sided confidence interval (CI) of 0.47 ~1.00. Median PFS was 7.3 months for AVASTIN ® (bevacizumab) plus fosbretabulin (n=54), compared to 4.8 months with AVASTIN ® (bevacizumab) alone (n= 53). Patients in both arms were treated until disease progression or adverse effects prohibited further therapy.
In a post-hoc subgroup analysis presented at the IGCS conference, data showed that patients who were platinum-resistant also had a statistically significant improvement in PFS with the combination. Among the 27 patients who were platinum-resistant, median PFS was 6.7 months for those receiving AVASTIN ® (bevacizumab) and fosbretabulin compared to 3.4 months for those receiving AVASTIN ® (bevacizumab) alone, with a p-value of 0.01. The hazard ratio was 0.57. Although the subgroup included a relatively small number of patients, these findings suggest that adding fosbretabulin to AVASTIN ® (bevacizumab) has a potentially greater effect in this difficult-to-treat patient group than for platinum-sensitive patients. Also in the post-hoc subgroup analysis, while not statistically significant, among the 80 patients who were platinum-sensitive, median PFS was 7.6 months for those receiving AVASTIN ® (bevacizumab) and fosbretabulin compared to 6.1 months for those receiving AVASTIN ® (bevacizumab) alone, with a p-value of 0.139 and a hazard ratio of 0.67.
In the study, patients with measurable disease who received the combination of fosbretabulin and AVASTIN ® (bevacizumab) also achieved a higher objective response rate, or ORR, a secondary endpoint in the study, measured according to RECIST criteria. Although not a statistically significant result, patients receiving the combination had an ORR of 35.7% (n=42; CI 90% 23.5 ~ 49.5%) compared to 28.2 percent for patients on AVASTIN ® (bevacizumab) alone (n=39; CI 90% 16.7 ~ 42.3%). In the small subgroup of platinum-resistant patients, the addition of fosbretabulin to AVASTIN ® (bevacizumab) treatment increased ORR to 40.0 percent (n=10) compared to 12.5 percent (n=8) for AVASTIN ® (bevacizumab) alone.
Additional secondary endpoints in the study included safety and overall survival. All adverse events in the study were manageable, with one Grade 4 event occurring in each treatment arm. Consistent with prior clinical experience with fosbretabulin, patients in the combination arm experienced an increased incidence of Grade 3 hypertension compared to the control arm (10 cases for AVASTIN ® (bevacizumab) as compared to 17 for the combination). One patient on the combination regimen had a Grade 3 thromboembolic event. All cases of hypertension were managed with antihypertensive treatments, as specified in the study protocol.
Patients continue to be followed for overall survival (OS). A preliminary analysis after 33 events did not demonstrate a statistically significant difference in OS between the study arms. However, we believe that the OS data currently available is not sufficiently mature to yield any definitive conclusions. Further analysis of this secondary endpoint will be conducted as the data matures.
AVASTIN ® (bevacizumab) is approved in the US in combination with chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan) for the treatment of women with platinum-resistant recurrent ovarian cancer, based on results from the Phase III AURELIA trial, the approval of which was based on progression free survival.
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AVASTIN ® (bevacizumab) is also approved in the EU in combination with different chemotherapy regimens for platinum-resistant and platinum-sensitive ovarian cancer, the approval of which was based on progression free survival.
Our current clinical development plan in ovarian cancer is as follows:
Fosbretabulin in combination with AVASTIN ® (bevacizumab)—Potential Future Development
In light of the results from the GOG-0186I trial, which demonstrated a prospectively defined statistically significant increase in progression-free survival from the combination of AVASTIN ® (bevacizumab) plus fosbretabulin as compared to AVASTIN ® (bevacizumab) alone, we are currently evaluating the potential development pathway, including the potential for a pivotal phase 3 clinical trial, for fosbretabulin in ovarian cancer. The subgroup analysis in platinum-resistant patients from the GOG-0186I trial suggests that adding fosbretabulin to AVASTIN ® (bevacizumab) has a potentially greater effect in this difficult-to-treat patient group than for platinum-sensitive patients, and therefore we currently plan to focus our potential development pathway on platinum-resistant ovarian cancer patients. We are also conducting discussions regarding our development pathway in ovarian cancer with leading experts in this indication and anticipate discussions with regulatory agencies in the second quarter of 2015 to determine a possible path forward for fosbretabulin in platinum-resistant ovarian cancer. Depending on the feedback from the FDA, we may file a special protocol assessment (SPA) relating to the development of fosbretabulin in this indication during the third quarter of 2015.
Fosbretabulin in combination with VOTRIENT ® (pazopanib)
GlaxoSmithKline (GSK)’s VOTRIENT ® (pazopanib) is an anti-angiogenic oral tyrosine kinase inhibitor that is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of renal cell carcinoma (RCC) and soft tissue sarcoma (STS), with compelling early clinical data in the treatment of relapsed ovarian cancer. We believe that using fosbretabulin in combination with VOTRIENT ® (pazopanib) may provide a clinically active yet potentially better tolerated alternative to the current standard of care, cytotoxic chemotherapy, for relapsed ovarian cancer.
In October 2014, the first patient was enrolled in a Phase 1b/2 trial of VOTRIENT ® (pazopanib) with and without fosbretabulin, in advanced recurrent ovarian cancer. The study is sponsored by The Christie Hospital NHS Foundation Trust and coordinated by the Manchester Academic Health Science Centre, Trials Coordination Unit, or MAHSC-CTU, with additional support from The University of Manchester, the Royal Marsden NHS Foundation Trust and Mount Vernon Cancer Centre (part of the East and North Hertfordshire NHS Trust). The trial design consists of a Phase 1b dose escalation portion with the combination of VOTRIENT ® (pazopanib) and fosbretabulin and a randomized Phase 2 portion comparing VOTRIENT ® (pazopanib) alone versus VOTRIENT ® (pazopanib) plus fosbretabulin in patients with relapsed ovarian cancer. The study is expected to enroll approximately 128 patients at sites in the U.K. The primary endpoint of the trial is progression-free survival, and secondary endpoints include safety, overall survival, objective response rate, and CA125 response rate.
As in the combination therapy trial of fosbretabulin with AVASTIN ® (bevacizumab), which was sponsored and substantially funded by the National Cancer Institute, we believe that the cooperative relationship among the participants in this trial, with VOTRIENT ® (pazopanib) supplied by GSK and fosbretabulin supplied by us, will minimize our costs associated with this trial. We will incur limited costs as required by the U.K.’s National Health Service (NHS) and the participating institutions for the duration of this trial and the costs of supplying fosbretabulin for the trial.
Gastrointestinal Neuroendocrine Tumors
The incidence of neuroendocrine tumors, or NETs, in 2004 in the US was approximately 5 per 100,000 people, indicating 14,000 new cases per year, and the incidence is increasing. Since patients with NETs can have prolonged survival rates of over 5 years, it is estimated that the prevalence is much higher, approximating 100,000 people in the US. The most common site of occurrence of NETs in the US population is in the gastrointestinal tract, with over half the tumors located at this site. These tumors are referred to as gastrointestinal
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neuroendocrine tumors, or GI-NETs. These tumors can produce increased amounts of materials including peptides, many of which are biologically active and can, in around 10 -20% of patients, result in debilitating symptoms including flushing, diarrhea, weight loss and, less frequently, bronchoconstriction and heart failure. These particular symptoms are caused by overproduction of biologically active substances such as serotonin and kallikrein, which are released directly into systemic circulation, bypassing hepatic degradation. While drug treatment with somatostatin analogs, such as Sandostatin ® , helps to control the symptoms, patients who are or become unresponsive to somatostatin or its analogs have limited therapeutic options. It is our belief, based on the available preclinical data, that by reducing blood flow to the tumors using fosbretabulin, we may be able to reduce the production of tumor-derived materials, including these biologically active substances. Although our initial focus in NETs is on GI-NETs, we believe that if our clinical development in this area is successful, this approach may have utility in other NETs and other hormone-producing tumors.
Our current clinical development plan in gastrointestinal neuroendocrine tumors is as follows:
Fosbretabulin monotherapy
In September 2014, we enrolled the first patient in a Phase 2 monotherapy clinical trial of fosbretabulin in patients with GI-NETs with elevated biomarkers. This trial is designed to enroll 20 GI-NET patients with increased biomarker levels at five sites in the United States. The primary endpoint of the trial is a reduction in biomarkers and secondary endpoints include symptom control and changes in quality of life as assessed by validated measures. We estimate that the trial will complete enrollment by the end of 2015. We also believe that there is the potential to receive interim data from this clinical trial by the end of 2015. Patients who participate in this trial are eligible to enroll in a rollover clinical trial which is designed to treat patients for one year after they complete the Phase 2 clinical trial if they have responded to our drug.
Background
A preclinical study of fosbretabulin in a transgenic mouse model of pancreatic neuroendocrine tumors, or PNETs, was presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, Boston, MA, in a poster session on October 20, 2013. This placebo-controlled preclinical study was designed to evaluate the activity of systemic administration of fosbretabulin for the treatment of functional insulinomas in a transgenic mouse model of PNETs. PNETs are highly vascularized tumors which originate in the pancreas. Functional PNETs make hormones that can cause a cascade of disease symptoms, resulting in significant morbidity for the patient. An insulinoma is a PNET that causes the over-secretion of the hormone insulin.
The animals in the treatment group received fosbretabulin three times per week for four weeks, and the animals in the control group received a placebo at the same schedule. After four weeks, tumor size, serum insulin levels and other efficacy parameters, including apoptosis (cell death), cell proliferation and effects on tumor vasculature, were assessed. Treatment with fosbretabulin in this animal model resulted in a significant and sustained decrease in circulating insulin of more than 90% over four weeks of treatment with fosbretabulin. Treatment with fosbretabulin was not shown to be associated with any obvious toxicity, and was shown to disrupt tumor vasculature, induce apoptosis and inhibit tumor cell proliferation.
Anaplastic Thyroid Cancer, or ATC
At this time our main focus with fosbretabulin is pursuing our programs in ovarian cancer and GI-NETs. While we have had discussions with the European regulatory agencies regarding the potential to submit a special marketing approval known as an MAA in the European Union for ATC under the “exceptional circumstances” pathway, and have received useful feedback, given our current priorities and resources, we have decided not to actively pursue such a filing at this time. Although this pathway continues to remain open to us, our near term priorities for fosbretabulin are focused on our development programs in ovarian cancer and completing our Phase 2 clinical trial in GI-NETs.
OXi4503 Development Program
In addition to pursuing development of fosbretabulin, we are also pursuing the development of a second product candidate, OXi4503, a novel, dual-mechanism VDA, which not only has been shown to reduce tumor blood flow but which also forms a potentially antiproliferative metabolite.
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We believe that this dual mechanism differentiates OXi4503 from other VDAs and may result in enhanced anti-tumor activity in certain tumor types as compared with other VDA drug candidates. Based on preclinical data, we believe that OXi4503 may be particularly active in hepatocellular carcinoma, melanoma, and leukemias of the myeloid lineage, all of which have relatively high levels of the enzymes that facilitate the conversion of OXi4503 into a chemical that directly kills tumor cells. Similar to fosbretabulin, OXi4503 has shown potent anti- tumor activity in preclinical studies of solid tumors and AML, and in two clinical studies in advanced solid tumors and liver tumors, both as a single agent and in combination with other antiproliferative agents.
Our current development program for OXi4503 is as follows:
Acute Myelogenous Leukemia, or AML
AML is a relatively rare cancer of the myeloid blood cells, with approximately 10,500 new cases each year in the United States and accounting for approximately 1.2% of cancer deaths. AML is characterized by the rapid growth of abnormal white blood cells that pollute bone marrow and interfere with the production of normal blood cells. Due to an unmet need in the treatment of AML and the small size of the indication, we have been granted orphan drug designation in the United States for the use of OXi4503 in the treatment of AML. We intend to seek orphan drug designation in the EU.
OXi4503—Investigator Sponsored Trial
OXi4503 has been under development in an ongoing investigator-sponsored Phase 1 trial of OXi4503 in patients with AML or MDS, a disorder of the normal blood formation process, being conducted at the University of Florida and with support by The Leukemia & Lymphoma Society’s Therapy Acceleration Program. This open-label, dose-escalating study was intended to treat up to 36 patients and evaluate the safety profile, maximum tolerated dose and biologic activity of OXi4503 in these patients. As of March 18, 2015, 16 patients have been enrolled into this study, and a maximum tolerated dose had not been observed. In an effort to increase enrollment at a faster rate, we are planning to close this trial and initiate our own sponsored clinical trial with additional sites as described below.
OXi4503—Company Sponsored Trial
In 2015 we intend to close the investigator sponsored Phase 1 trial of OXi4503 in patients with AML or MDS and initiate our own Phase 1/2 trial which will initially be an open-label, dose-escalating study intended to treat up to an additional 20 patients, at 3-6 sites and evaluate the safety profile, maximum tolerated dose and biologic activity of OXi4503 in these patients.
Background
Updated data from the investigator trial was presented at the December 2013 annual meeting of ASH in New Orleans, Louisiana. Among the first 13 patients treated at the two lowest dose levels, two patients showed stable disease, one patient had a partial remission and one patient achieved a complete bone marrow response. Side effects included increases in D-dimer, which is a substance in the blood that is released when a blood clot breaks up, bone pain, fever, chills and flu-like symptoms. Accordingly, OXi4503 appears to be well tolerated based on these results to date in patients with relapsed and refractory AML and MDS. Biological activity associated with OXi4503 includes temporary increases in D-dimer which may be related to anti-leukemic activity of the drug.
Vascular Disrupting Agents: Background
According to Cancer Research UK, a non-profit cancer research organization in the United Kingdom, nearly 90% of all cancers are solid tumors that are dependent upon a continually evolving vascular supply for their growth and survival. Similarly, in the ophthalmology field, abnormal neovascularization characterizes a variety of ophthalmological diseases and conditions, including wet age-related macular degeneration, or AMD, and diabetic retinopathy.
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Since 2004, a number of anti-angiogenic drugs, which refers to drugs that interfere with blood vessel growth, as described further in the 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.
While fosbretabulin exerts a therapeutic effect similar to existing anti-angiogenic agents, depriving tumors (or, in the case of eye disease, ocular lesions) of blood supply, its mechanism of action is quite different. Consequently, we believe that our VDA drug candidates are second-generation anti-vascular drugs that are potentially complementary to, rather than directly competitive with, existing anti-angiogenic agents, a stance which is supported by the data we have gathered showing an improvement in patient outcomes when both agents are used in combination. Several preclinical studies, as well as the results of the Phase 2 GOG-0186I clinical trial, have confirmed the potential of this approach.
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 preclinical 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 fosbretabulin and AVASTIN ® (bevacizumab), provide support and initial clinical validation for combining these agents to significantly increase clinical activity without significantly increasing side-effects. Additionally, positive study results from the Phase 2 GOG-0186I clinical trial indicated a statistically significant increase in PFS with the combination of fosbretabulin and bevacizumab.
| Anti-Angiogenic Drugs | fosbretabulin tromethamine | OXi4503 | ||||
|
Molecule Characteristics |
Bevacizumab,
ranibizumab are monoclonal antibodies (MABs)
Sorafenib, sunitinib,
|
Small molecule
reversible inhibitor of tubulin polymerization |
Small molecule
reversible inhibitor of tubulin polymerization
Additionally forms
|
|||
|
Biological Effect |
Continuously inhibit pro-
angiogenic growth factor signaling (e.g., VEGF) to prevent formation and growth of new blood vessels throughout the tumor rim |
Intermittently and
reversibly occludes and collapses pre-existing abnormal tumor blood vessels that feed tumors |
Similar to fosbretabulin.
In addition, temporarily mobilizes hematopoietic and leukemic cells from the bone marrow |
|||
|
Target tissue |
Promiscuous for all
angiogenesis |
Selective for abnormal
vasculature characteristic of tumors and certain eye lesions |
Similar to fosbretabulin.
Makes leukemic cells mobilized from the bone marrow vulnerable for the effects of the orthoquinone metabolite |
|||
|
Mechanism |
MABs bind to VEGF,
thereby rendering it inactive
TKIs inhibit downstream
|
Selectively blocks
formation of tumor vessel and other abnormal vessel tissue junctions by disrupting the cell junctional protein VE- cadherin |
Similar to fosbretabulin.
Additionally, orthoquinone metabolite has antiproliferative effect on leukemic cells |
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| Anti-Angiogenic Drugs | fosbretabulin tromethamine | OXi4503 | ||||
|
Plasma Half-life |
MABs remain in
circulation for days or weeks |
Approximately 4 hours |
Approximately 2 hours,
OXi4503 metabolite half- life is approximately 20 hours |
|||
|
Rapidity of Effect |
Weeks | Hours | Hours | |||
|
Target |
Tumor Rim | Tumor Core |
Tumor core.
Additionally, malignant cells of myeloid lineage |
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|
Side Effects |
Chronic-chronic
hypertension with long- term use; Acute- impairment in wound healing; Hemorrhage, hemoptysis, gastrointestinal perforation, proteinuria, nephrotic syndrome, thromboembolic events, etc. |
Transient and
manageable. Mostly hypertension, effectively controlled; Overlapping with anti-angiogenics; No cumulative toxicities alone or in combination |
Transient and
manageable. Mostly hypertension, effectively controlled; Effects on hematopoiesis and white blood cell counts |
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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 in 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 vitro studies 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 vasculature. By binding to the tubulin, fosbretabulin 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 fosbretabulin and OXi4503.
Preclinical research, published in the November 2005 issue of the Journal of Clinical Investigation, showed that fosbretabulin 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.
Preclinical and clinical study results indicate that fosbretabulin exerts anti-vascular effects rapidly, within hours of administration, and the half-life of the active form of fosbretabulin in humans is approximately four hours. Because the half-life of the active form of fosbretabulin is relatively short, the effects of fosbretabulin on tubulin are reversible, and fosbretabulin is typically administered no more frequently than once per week, the side-effects of fosbretabulin are typically transient in nature, limited to the period of time following administration when the active form of fosbretabulin 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 fosbretabulin are typically transient and manageable. The most frequent fosbretabulin side-
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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, fosbretabulin also exhibits cardiovascular effects, which in the majority of patients are mild and transient in nature. Approximately 10-20% of patients treated with fosbretabulin 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.
Collaborative Research and Development Arrangements
Our strategy is to develop innovative therapeutics for oncology. Our principal focus is to advance the clinical development and commercialization of our drug candidates fosbretabulin and OXi4503 and to identify new preclinical 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 2014, collaborations and agreements were ongoing with a variety of university and research institutions, including the following:
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Baylor University, Waco, Texas |
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UT Southwestern, Texas |
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University of Oxford, Oxford, United Kingdom |
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Gynecologic Oncology Group, and the Cancer Therapy Evaluation Program of the National Cancer Institute |
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Institute for Cancer Research UK |
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University of Florida |
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Azanta Danmark A/S |
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Aarhus University, Denmark |
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Albert Einstein College of Medicine of Yeshiva University |
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Angiogene Pharmaceuticals, Ltd. |
In December 2011, we established a distribution agreement with a Danish company, Azanta Danmark A/S, or Azanta, to provide access to fosbretabulin for the treatment of patients with ATC on a compassionate use basis in certain specified territories, which was expanded to include additional territories in August 2012. This agreement was terminated effective December 31, 2014. The specified territories included the European Union, including the Nordic countries and Switzerland, Canada, Israel and South Korea. This program, which was managed by Azanta, provided a regulatory mechanism to allow healthcare professionals in the specified territories to prescribe fosbretabulin to individual ATC patients while it is still in development. Under the terms of the agreement, we provided fosbretabulin to the Danish company, and they served as our exclusive distributor for fosbretabulin in the specified territories for this purpose. The Danish company provided fosbretabulin to physicians solely to treat ATC on a compassionate use basis in the specified territories until such time as fosbretabulin may have obtained marketing approval in that territory. The Danish company was responsible for all regulatory activities necessary to distribute and sell fosbretabulin on a compassionate use basis for the treatment of ATC within the specified territories. There was no transfer of ownership of intellectual property rights for fosbretabulin to the Danish company under the terms of the agreement.
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We have secured a technology license from Arizona State University, or 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, fosbretabulin and OXi4503. Combretastatins were originally isolated from the bark of the South African Bush Willow tree by researchers from Arizona State University but are now created by synthetic means and have tubulin-dependent anti-vascular and antiproliferative properties. 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. In addition, we may terminate the agreement by either (i) determining that filing for regulatory approval is not warranted by the clinical testing date or (ii) by providing two months written notice of our intent to terminate the agreement. Payments made to ASU to date have amounted to $2,600,000. The agreement remains in force until the expiration of the last to expire patent subject to the ASU license.
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 believe that our hypoxia-activated VDAs could serve as line-extension products to fosbretabulin and/or OXi4503. We also have an exclusive license from Baylor University to all novel compositions developed 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 stipulates that low-single-digit royalties will be paid by us should sales be generated through use of Baylor’s compounds. Further, commencing in the first year that we provide no research funding to Baylor University we must pay a minimum annual royalty payment of $40,000. We are not required to pay Baylor for use of Baylor’s compounds other than pursuant to this royalty 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. Either party may terminate the license agreement upon material default of the other party. The term of the license shall end upon the expiration of the licensed patents. The latest U.S. patent licensed under this agreement is scheduled to expire in November 2030.
We also have an exclusive, world-wide, royalty-bearing license from Bristol-Myers Squibb, or BMS, for commercial development, use and sale of products or services covered by certain patent rights to particular combretastatins, including among others, fosbretabulin. Under the BMS license, we have the right to grant sublicenses. Under the license agreement, BMS is entitled to low-single-digit royalty payments for all commercial sales plus any remuneration OXiGENE receives for sale of fosbretabulin under named patient or compassionate use programs. 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, excluding a patent term extension available under the Hatch-Waxman Act.
In June 2012, we secured a royalty-bearing, transferable, worldwide, exclusive license from Angiogene Pharmaceuticals Ltd. to make, have made, use, import, offer for sale, and sell a vascular disrupting agent, such as fosbretabulin, for treating neuroendocrine tumors and associated symptoms and syndromes. Under the Angiogene license, we have the right to grant sublicenses. Angiogene is entitled to low single-digit royalty payments and milestone payments under the agreement. Milestone payments are due upon initiation of the first clinical trial for a product using Angiogene intellectual property and initiation of the first registration clinical trial
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for a product using Angiogene intellectual property. We have the sole right to and bear the costs of preparing, filing, prosecuting and maintaining all patent applications under the Angiogene license. Payments to Angiogene under this license to date have amounted to $300,000. The term of the royalty payable under the license will expire on the sooner of (i) ten years from the regulatory approval of a product subject to the license or (ii) launch by a third party of a generic version of the vascular disrupting agent. After the expiry of the royalty term, the license will become fully paid, irrevocable and perpetual. Either party may terminate the license upon material default of the other party, and we may terminate the agreement at will upon sixty days prior notice to Angiogene.
Company Background
We are a Delaware corporation, originally 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). 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 & Media” 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 Annual Report on Form 10-K.
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 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:
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completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices (GLP) or other applicable regulations; |
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submission to the FDA of an investigational new drug application, or IND, which must be first approved by the FDA before human clinical trials may begin; |
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performance of adequate and well-controlled human clinical trials according to Good Clinical Practices (GCP) to establish the safety and efficacy of the proposed drug for its intended use; |
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submission to the FDA of an NDA; |
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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; |
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satisfactory completion of FDA inspections of clinical sites and GLP toxicology studies; and |
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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 preclinical testing stage. Preclinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the preclinical 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. Preclinical 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 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 and efficacy in Phase 2 and 3 clinical trials.
Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:
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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. |
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Phase 2: Involves studies in a limited patient population to identify possible adverse effects and safety risks, to evaluate preliminary efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. |
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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
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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, preclinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug, proposed labeling, and other 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, which may include orphan drug status and the first NDA application for a company.
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
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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.
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, could also 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.
Fosbretabulin was awarded orphan drug status by the FDA for the treatment of anaplastic, medullary, Stage IV papillary and Stage IV follicular thyroid cancers and ovarian cancer. OXi4503 was awarded orphan drug status by the FDA for the treatment of acute myelogenous leukemia.
Fosbretabulin was also awarded orphan drug status by the European Commission in the European Union for the treatment of anaplastic thyroid cancer and ovarian 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
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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.
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 through a centralized, a decentralized or mutual recognition procedure. 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. The centralized procedure is also mandatory for cancer indications and orphan drug products. Based on these requirements, the centralized procedure would be used for our two current product candidates, fosbretabulin and OXi4503.
In Europe, alternative pathways for marketing approval include conditional approval or approval under exceptional circumstances. These pathways are available for drugs to treat serious or debilitating diseases and/or orphan drugs. Both conditional approval and approval under exceptional circumstances require a positive risk/benefit balance. Under conditional approval it is expected that additional clinical studies would support the lack of comprehensive clinical data provided at the time of the filing. Approval under exceptional circumstances is possible when the indication is so rare that the applicant cannot reasonably be expected to provide comprehensive clinical data. We have evaluated the potential benefits of seeking approval under exceptional circumstances for the use of fosbretabulin in ATC. However, given our current priorities and resources, we have decided not to actively pursue such a filing at this time.
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 18, 2015, we were the exclusive licensee, sole assignee or co-assignee of twenty-seven (27) granted U.S. patents, six (6) pending U.S. 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 U.S. 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
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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 U.S. patents and applications 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 |
||
|
Fosbretabulin tromethamine |
Lyophilized or crystalline combretastatin A-4 phosphate tromethamine* | September 2021 | ||
| Methods of modulating tumor growth or metastasis by administration of combretastatin A-4 phosphate and paclitaxel* | December 2021 | |||
| Method of treating NET including carcinoid tumor symptoms by administering fosbretabulin*** | June 2033 | |||
|
OXi4503** |
Composition of matter for OXi4503 (combretastatin-A1-disodium-phosphate (OXi4503) pro-drug)**
Method of treating myeloid neoplasm by administering OXi4503**** |
October 2021
November 2028 |
||
| * | In-licensed from Bristol-Myers Squibb |
| ** | In-licensed from Arizona State University |
| *** | In-licensed from Angiogene Pharmaceuticals Ltd.; patent filed, awaiting grant |
| **** | Patent filed, awaiting grant |
In addition to these patents, for some of our product candidates, we have patents and/or applications that cover a particular form or composition, use for a particular indication, use 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 an 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.
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.
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We are aware of a limited number of companies involved in the development of VDAs. Such companies include Bionomics, Immune Pharmaceuticals, and MediciNova, all of which have VDAs that we believe are at an earlier or similar stage of clinical development than our lead drug candidate, fosbretabulin.
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 for much of our research, development, preclinical testing and clinical trial activity, although we maintain managerial and quality control over our clinical trials. As of March 25, 2015, we had a total of 13 full-time employees and 1 employee 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 us or by officers, directors or employees acting on our 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 our actual results 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.
RISKS RELATED TO OUR BUSINESS
We will be required to raise additional funds to finance our operations and continue the development of our product candidates; 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.
We are pursuing 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 products, in order to continue the development of our product candidates. However, there can be no assurances that we will complete any financings, strategic alliances or collaborative development agreements, and the terms of such arrangements may not be advantageous to us.
After our financing in March 2015, we expect our existing cash to support our operations through approximately the end of 2017. We expect this level of cash utilization to allow us to advance our ongoing programs, including completion of a Phase 2 clinical trial of fosbretabulin in patients with recurrent GI-NETs with elevated biomarkers including a rollover clinical trial designed to treat patients for one year after they complete the Phase 2 clinical trial if they have responded to fosbretabulin; the initiation and completion of the Phase 1 portion, and initiation of the Phase 2 portion, of an open-label clinical trial of OXi4503 in patients with AML to be sponsored by us; and supporting a Phase 1b/2 trial of fosbretabulin in relapsed ovarian cancer in combination with Votrient ® (pazopanib), being sponsored by two UK-based nonprofit organizations. While our
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existing cash will support the planning for a follow-on clinical program in fosbretabulin for the treatment of ovarian cancer, any significant further clinical development of fosbretabulin in advanced recurrent ovarian cancer, including the potential development of a special protocol assessment with the FDA, and conducting follow-on clinical studies or other capital intensive activities, will be contingent upon our ability to raise additional capital in addition to our existing financing arrangements or from a collaborative research agreement with a third-party, as to which we can give you no assurance.
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; the costs of complying with FDA and other regulatory agency 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; 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.
While we potentially have access to certain amounts of financing through an At Market Issuance Sales Arrangement, which we refer to as the ATM, with MLV & Co. LLC, these arrangements alone will not be sufficient to fund a late-stage clinical trial of fosbretabulin in any indication. In addition, we may be restricted by the terms of financing arrangements that we may enter into from making sales under the ATM Agreement. 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 funds through public or private financing, strategic partnerships or other arrangements. Any additional equity financing, whether through the ATM or otherwise, 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.
Due in part to our limited 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 curtailed clinical development programs and activities that might otherwise have led to more rapid progress of our product candidates through the regulatory and development processes.
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. We or our partners currently are pursuing clinical trials in various indications, but we are required by our financial resources to engage only in limited clinical activities. 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
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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 are unable to 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, in the European Union and in many other 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 or EMA is unpredictable and often exceeds five years following the commencement of clinical trials, depending upon the complexity of the product candidate.
In connection with the clinical development of our product candidates, we face risks that:
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the product candidate may not prove to be safe and efficacious; |
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patients may die or suffer serious adverse effects for reasons that may or may not be related to the product candidate being tested; |
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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, EMA or other regulatory agencies; |
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we may not have sufficient financial resources to complete the clinical trials that would be necessary to obtain regulatory approvals; |
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the results of later-phase clinical trials may not confirm the results of earlier clinical trials; and |
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the results from clinical trials may not meet the level of statistical significance or clinical benefit-to-risk ratio required by the FDA, EMA or other regulatory agencies for marketing approval. |
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 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 for the foreseeable future. We rely heavily on these parties for successful execution of our clinical trials. Nonetheless, we 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, we have clinical trial activities involving fosbretabulin and OXi4503 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
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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 also found that some of the clinical trial monitors selected by our clinical research organizations, or CROs, outside the United States 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 of our systems, practices and procedures governing the areas of vendor oversight, quality, and regulatory compliance and were initially disclosed by us in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2009. 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. On February 10, 2014, we received correspondence from the FDA informing us that we appear to have taken corrective action to prevent the recurrence of the conditions that led to the issuance of the Form FDA 483 and that the related inspection is now closed.
While we have taken and continue to take steps 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 procedures, 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. In addition, the steps we take to strengthen our procedures and conduct future clinical trials necessary for approval will be time-consuming and expensive.
We may encounter difficulties in expanding our operations successfully if and when we evolve from a company that is primarily involved in clinical development to a company that is also involved in commercialization.
As we advance our product candidates through clinical trials, we will need to expand our development, regulatory, manufacturing, marketing and sales capabilities or contract with third parties to provide these capabilities for us. As our operations expand, we expect that we will need to manage additional relationships with such third parties, as well as additional collaborators, distributors, marketers and suppliers.
Maintaining third party relationships for these purposes will impose significant added responsibilities on members of our management and other personnel. We must be able to: manage our development efforts effectively; manage our participation in the clinical trials in which our product candidates are involved effectively; and improve our managerial, development, operational and finance systems, all of which may impose a strain on our administrative and operational infrastructure.
If, following any approval of our product candidates, we enter into arrangements with third parties to perform sales, marketing or distribution services, any product revenues that we receive, or the profitability of these product revenues to us, are likely to be lower than if we were to market and sell any products that we develop ourselves. In addition, we may not be successful in entering into arrangements with third parties to sell and market our products or in doing so on terms that are favorable to us. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our products.
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If we were to file for a new drug application for our drug candidates in the United States or in the EU, we would need to undertake commercial scale manufacturing activities at significant expense to us in order to proceed with the application for approval for commercialization. We or our external vendors may encounter technical difficulties that preclude us from successfully manufacturing the required registration and validation batches of active pharmaceutical ingredient, or API, and/or drug product and we may be unable to recover any financial losses associated with the manufacturing activities. 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 no manufacturing capacity and have relied on, 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 resources and the capabilities to do so. As a result, we currently rely, and we expect to rely for the foreseeable 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:
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reliance on third-parties for manufacturing process development, regulatory compliance and quality assurance; |
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limitations on supply availability resulting from capacity and scheduling constraints of third-parties; |
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the possible breach of manufacturing agreements by third-parties because of factors beyond our control; and |
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the possible termination or non-renewal of the manufacturing agreements by the third-party, at a time that is costly or inconvenient to 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, EMA and other foreign regulatory authorities.
The FDA, EMA and other 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, EMA 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.
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 the clinical 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.
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The products currently under development by us may require significant additional research and development and additional 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 products to be safe or capable of producing a desired result. Additionally, we may encounter problems in our clinical trials that may cause us to delay, suspend or terminate those clinical trials.
Our product candidates have been tested in over 450 patients to date, and adverse events associated with fosbretabulin and OXi4503 have been found to be mainly low grade, reversible, transient and manageable. However, we will be required to continue to test and evaluate the safety of our product candidates in additional clinical trials, and to demonstrate their safety to the satisfaction of appropriate regulatory agencies, as a condition to receipt of any regulatory approvals. In clinical trials to date, transient mild to moderate hypertension believed to be associated with fosbretabulin has been effectively managed through pre-treatment with antihypertensive medication. We cannot assure you, however, that we will be able to make the necessary demonstrations of safety to allow us to receive regulatory approval for our product candidates in any indication.
We only have a limited number of employees to manage and operate our business.
As of March 25, 2015, we had a total of 13 full-time employees and 1 employee working on a part-time basis. Our 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, 2014, had an accumulated deficit of approximately $251,155,000. We anticipate continuing to incur substantial additional losses over at least the next several years due to, among other factors, our continuing clinical trials and development activities 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 yet commercialized any product candidates. Our ability to attain profitability will depend upon our ability to develop and commercialize 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 product candidates may become obsolete.
We are engaged in a rapidly evolving field. Competition from other pharmaceutical companies, biotechnology companies and research and academic institutions is intense and likely 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, conducting clinical
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trials, 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 three other companies that currently have 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 competitors may succeed in developing products that are more effective and/or cost competitive than those we are developing, or that would render our product candidates 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 depend extensively on our patents and proprietary technology and the patents and proprietary technology we license from others, and we must protect those assets in order to preserve our business.
We have licensed in rights to fosbretabulin, 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 fosbretabulin 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 fosbretabulin and OXi4503 and from Baylor University and Angiogene Pharmaceuticals Ltd. 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, the Bristol-Myers Squibb Company, Baylor University and Angiogene Pharmaceuticals Ltd., we could lose our rights under these agreements. Any such dispute 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 18, 2015, we were the exclusive licensee, sole assignee or co-assignee of twenty-seven (27) granted United States patents, six (6) pending United States patent applications, and granted patents and/or pending applications in several other major markets, including the
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European Union, Canada and Japan. The patent position of pharmaceutical and biotechnology firms like us is 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, because 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, 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 a party to any such agreement during the course of the relationship with us be kept confidential and not 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 clinical trials or regulatory approval processes 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:
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conditions imposed on us by the FDA, EMA or another foreign regulatory authority regarding the scope or design of our clinical trials; |
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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; |
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insufficient supply of our product candidates or other materials necessary to conduct and complete our clinical trials; |
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slow enrollment and retention rate of subjects in clinical trials; |
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any compliance audits and pre-approval inspections by the FDA, EMA or other regulatory authorities; |
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negative or inconclusive results from clinical trials, or results that are inconsistent with earlier results; |
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serious and unexpected drug-related side effects; and |
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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, EMA or another foreign regulatory authority or the requirement of additional supportive studies by the FDA, EMA or another 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 and EMA 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.
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, EMA and other applicable domestic and foreign regulatory authorities or previously unknown problems with any approved product, manufacturer, or manufacturing process are discovered, we could be subject to administrative or judicially imposed sanctions, including:
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restrictions on the products, manufacturers, or manufacturing processes; |
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warning letters; |
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civil or criminal penalties; |
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fines; |
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injunctions; |
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product seizures or detentions; |
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pressure to initiate voluntary product recalls; |
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suspension or withdrawal of regulatory approvals; and |
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refusal to approve pending applications for marketing approval of new products or supplements to approved applications. |
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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:
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timing of market introduction of competitive products; |
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demonstration of clinical safety and efficacy compared to other products; |
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cost-effectiveness; |
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limited or no coverage by third-party payers; |
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convenience and ease of administration; |
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prevalence and severity of adverse side effects; |
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restrictions in the label of the drug; |
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other potential advantages of alternative treatment methods; and |
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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.
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 in the United States and in foreign jurisdictions. 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 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
25
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, and the price we may charge for, any products we develop that receive regulatory approval. We also cannot predict the impact of ACA on us as many of the ACA reforms require the promulgation of detailed regulations implementing the statutory provisions, which have not yet been fully implemented.
Our facility with MLV will not be sufficient to satisfy our capital requirements for all of our contemplated clinical trials.
On July 21, 2010, we entered into an “at the market” equity offering sales agreement, or ATM Agreement, with MLV & Co. LLC, or 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 ATM Agreement. The amount that we could sell under the ATM Agreement may be limited as to how many shares we can sell under the ATM Agreement due to limitations imposed by the Securities and Exchange Commission, or the SEC, 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. Additionally the amount we could sell may be limited depending on the price of our common stock and the shares outstanding, among other factors, to the extent it is available at all. The funding available from MLV 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 MLV 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 MLV 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 MLV 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. In addition, we are restricted for 90 days under the terms of our last financing which closed on March 25, 2015, and in the future we may be restricted by the terms of other financing arrangements that we may enter into from making sales under the ATM Agreement.
Our restated certificate of incorporation, our amended and restated by-laws 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 our best interests.
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 an 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
26
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, 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.
If we fail to maintain an effective system of internal controls over financial reporting, we may not be able to accurately report our financial results. As a result, current and potential stockholders could lose confidence in our financial reporting, which could harm our business and the trading price of our stock.
Effective internal controls over financial reporting are necessary for us to provide reliable financial reports. If we cannot maintain effective controls and reliable financial reports, our business and operating results could be harmed. For example, during the third quarter of 2013, our management determined that we had a material weakness related to the operation of our controls over financial reporting associated with a complex non-routine financing transaction in the second quarter of 2013. We conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2014 based on the framework in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (1992 Framework) (COSO). Based on that evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2014. We continue to work on improvements to our internal controls over financial reporting and there can be no assurance that another material weakness will not occur in the future. Any failure to implement and maintain controls over our financial reporting or difficulties encountered in the implementation of improvements in our controls, could cause us to fail to meet our reporting obligations. Any failure to improve our internal controls over financial reporting or to address identified weaknesses in the future, if they were to occur, could also cause investors to lose confidence in our reported financial information, which could have a negative impact on the trading price of our stock.
Issuance of additional equity securities may adversely affect the market price of our common stock.
We are currently authorized to issue 70,000,000 shares of our common stock. As of March 25, 2015, we had 26,544,934 shares of common stock issued and outstanding, excluding shares issuable upon the exercise of our outstanding warrants and options, and we had no shares of preferred stock outstanding. As of March 25, 2015, we also had 10,598,854 warrants and 689,431 options outstanding, of which 315,014 options are currently fully vested or vest within the next 60 days.
To the extent that shares of common stock are issued or options and warrants are exercised, holders of our common stock will experience dilution. In addition, in the event of any future issuances of equity securities or securities convertible into or exchangeable for common stock, holders of our common stock may experience dilution.
Moreover, our board of directors is authorized to issue preferred stock without any action on the part of our stockholders. Our board of directors also has the power, without stockholder approval, to set the terms of any such preferred stock that may be issued, including voting rights, conversion rights, dividend rights, preferences over our common stock with respect to dividends or if we liquidate, dissolve or wind up our business and other terms. If we issue preferred stock in the future that has preference over our common stock with respect to the payment of dividends or upon our liquidation, dissolution or winding up, or if we issue preferred stock with voting rights that dilute the voting power of our common stock, the market price of our common stock could decrease. Any provision permitting the conversion of any such preferred stock into our common stock could result in significant dilution to the holders of our common stock.
We also consider from time to time various strategic alternatives that could involve issuances of additional common stock, including but not limited to acquisitions and business combinations, but do not currently have any definitive plans to enter into any of these transactions.
We have no plans to pay dividends on our common stock, and you may not receive funds without selling your common stock.
We have not declared or paid any cash dividends on our common stock, nor do we expect to pay any cash dividends on our common stock for the foreseeable future. We currently intend to retain any additional future earnings to finance our operations and growth and for future stock repurchases and, therefore, we have no plans
27
to pay cash dividends on our common stock at this time. Any future determination to pay cash dividends on our common stock will be at the discretion of our board of directors and will be dependent on our earnings, financial condition, operating results, capital requirements, any contractual restrictions, and other factors that our board of directors deems relevant.
Accordingly, our investors may have to sell some or all of their common stock in order to generate cash from your investment. You may not receive a gain on your investment when you sell our common stock and may lose the entire amount of your investment.
| ITEM 1B. | UNRESOLVED STAFF COMMENTS |
None.
| ITEM 2. | PROPERTIES |
OXiGENE’s corporate headquarters is located in South San Francisco, California where we lease 5,275 square feet of general office space. The lease for this space, as amended, expires on June 30, 2019. The space will meet our needs for the foreseeable future.
| ITEM 3. | LEGAL PROCEEDINGS |
Not applicable.
| 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”. The following table sets forth, for the periods indicated, the high and low sales prices of our common stock (rounded to the nearest penny) on The NASDAQ Global Market and The NASDAQ Capital Market, as applicable, as reported by NASDAQ, for each quarterly period during the two most recent fiscal years and subsequent interim periods.
| 2014 | 2013 | |||||||||||||||
| High | Low | High | Low | |||||||||||||
|
First Quarter |
$ | 5.40 | $ | 1.96 | $ | 5.90 | $ | 3.83 | ||||||||
|
Second Quarter |
$ | 3.92 | $ | 2.41 | $ | 4.95 | $ | 2.61 | ||||||||
|
Third Quarter |
$ | 2.70 | $ | 2.06 | $ | 3.85 | $ | 2.03 | ||||||||
|
Fourth Quarter |
$ | 2.53 | $ | 1.48 | $ | 4.58 | $ | 2.29 | ||||||||
On March 25, 2015, the closing price of the Company’s common stock on The NASDAQ Capital Market was $1.44 per share.
As of March 25, 2015, there were approximately 44 stockholders of record of the 26,544,934 outstanding shares of the Company’s 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.
Information relating to compensation plans under which our equity securities are authorized for issuance is presented in Part III, Item 12 of this Form 10-K.
Unregistered Sales of Securities
None.
28
| 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, 2014. The selected financial data for each of the five years in the period ended December 31, 2014 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. In addition, in December 2012, the Company’s board of directors voted unanimously to implement a 1:12 reverse stock split of the Company’s common stock, following authorization of the reverse split by a shareholder vote on December 21, 2012. The reverse split became effective on December 28, 2012. All of the share information shown in the table below has been adjusted to reflect the effect of these reverse splits.
| Years ended December 31, | ||||||||||||||||||||
| 2014 | 2013 | 2012 | 2011 | 2010 | ||||||||||||||||
| (Amounts in thousands except per share data) | ||||||||||||||||||||
|
STATEMENT OF OPERATIONS DATA: |
||||||||||||||||||||
|
Product revenues |
$ | — | $ | 95 | $ | 156 | $ | — | $ | — | ||||||||||
|
Operating expenses: |
||||||||||||||||||||
|
Research and development |
7,408 | 3,636 | 3,523 | 5,291 | 12,114 | |||||||||||||||
|
General and administrative |
5,242 | 4,739 | 4,690 | 5,375 | 5,885 | |||||||||||||||
|
Restructuring |
— | — | 15 | 1,226 | 510 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
Total operating expenses |
12,650 | 8,375 | 8,228 | 11,892 | 18,509 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
Loss from operations |
(12,650 | ) | (8,280 | ) | (8,072 | ) | (11,892 | ) | (18,509 | ) | ||||||||||
|
Change in fair value of warrants |
— | — | 6 | 2,222 | (6,018 | ) | ||||||||||||||
|
Investment income |
6 | 4 | 12 | 7 | 17 | |||||||||||||||
|
Other (expense) income, net |
(3 | ) | (1 | ) | (25 | ) | 10 | 740 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
Net loss and comprehensive loss |
(12,647 | ) | (8,277 | ) | (8,079 | ) | (9,653 | ) | (23,770 | ) | ||||||||||
|
Non-cash deemed dividend to preferred stock |
— | (4,799 | ) | — | — | — | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
Net loss applicable to common stock |
$ | (12,647 | ) | $ | (13,076 | ) | $ | (8,079 | ) | $ | (9,653 | ) | $ | (23,770 | ) | |||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
Basic and diluted net loss per share attributable to common stock |
$ | (0.75 | ) | $ | (4.67 | ) | $ | (5.48 | ) | $ | (10.37 | ) | $ | (71.60 | ) | |||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
Weighted-average number of common shares outstanding |
16,973 | 2,803 | 1,473 | 931 | 332 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
29
| Years ended December 31, | ||||||||||||||||||||
| 2014 | 2013 | 2012 | 2011 | 2010 | ||||||||||||||||
| (Amounts in thousands except per share data) | ||||||||||||||||||||
|
BALANCE SHEET DATA: |
||||||||||||||||||||
|
Cash, restricted cash and equivalents |
$ | 30,031 | $ | 7,005 | $ | 4,966 | $ | 9,992 | $ | 4,677 | ||||||||||
|
Working capital |
29,004 | 5,914 | 4,342 | 8,388 | 1,797 | |||||||||||||||
|
Total assets |
30,423 | 7,294 | 5,447 | 11,056 | 5,567 | |||||||||||||||
|
Total liabilities |
1,419 | 1,251 | 901 | 2,259 | 10,822 | |||||||||||||||
|
Accumulated deficit |
(251,155 | ) | (238,508 | ) | (225,432 | ) | (217,353 | ) | (207,700 | ) | ||||||||||
|
Total stockholders’ (deficit) equity |
29,004 | 6,043 | 4,546 | 8,797 | (5,255 | ) | ||||||||||||||
| 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 prices are volatile and may be influenced by regulatory and other factors beyond our control.
We are a biopharmaceutical company primarily focused on the development of vascular disrupting agents, or VDAs, for the treatment of cancer. We have two clinical stage product candidates that we are currently developing in three potential oncology indications. Our lead compound, fosbretabulin, is currently being tested in two indications, recurrent ovarian cancer and gastrointestinal neuroendocrine tumors, or GI-NETs, and our second compound, OXi4503, is currently being tested in patients with relapsed or refractory acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS). We have been granted orphan drug designation for fosbretabulin in the treatment of ovarian cancer in the United States and the European Union, and for OXi4503 in the treatment of AML in the United States. To date, we have observed fosbretabulin to be well tolerated in over 450 patients and to have clinical activity in a variety of indications including ovarian cancer.
We are pursuing what we believe to be a cost-efficient, risk-mitigated development strategy. In the United States and Europe, we are pursuing collaborations with established pharmaceutical companies with products whose efficacy we believe can be enhanced by the addition of fosbretabulin, and with non-profit research organizations such as The Christie Hospital NHS Foundation Trust, an international leader in cancer research and development, and the Gynecologic Oncology Group(GOG), now part of NRG Oncology, an organization dedicated to clinical research in the field of gynecologic cancer, for the treatment of advanced ovarian cancer.
During 2014 our resources were focused primarily on evaluating the potential clinical pathway for fosbretabulin in ovarian cancer after receiving positive study results in ovarian cancer from the Phase 2 clinical trial which was conducted by the GOG, the initiation of our Phase 2 clinical trial testing of fosbretabulin in GI-NETs, supporting the initiation of the Phase 1b/2 clinical trial in ovarian cancer being conducted by The Christie Hospital NHS Foundation comparing fosbretabulin in combination with pazopanib, and the manufacture of fosbretabulin for clinical supply and possibly to support any regulatory filings. We also continued to support our Phase 1 clinical trial testing OXi4503 in AML, being conducted by the University of Florida, and our distribution agreement for the compassionate use of fosbretabulin in ATC (which was terminated effective December 31, 2014).
During 2013 and 2012 we focused our capital resources on our most promising early-stage clinical programs with the goal of maximizing our highest value clinical assets while reducing our cash utilization. Accordingly,
30
our resources were focused on supporting our ovarian cancer Phase 2 clinical trial which was being conducted by the GOG, our Phase 1 clinical trial in AML, being conducted by the University of Florida, our distribution agreement for the compassionate use of fosbretabulin in ATC, and the manufacture of fosbretabulin for clinical supply and possibly to support any regulatory filings.
In 2012 and earlier years, we also spent resources completing our ATC trial, or the FACT trial, and designing a Phase 3 registrational study in ATC, or the FACT 2 trial, and while we were successful in receiving a SPA with the FDA for the FACT 2 trial, we subsequently determined that this trial was not financially feasible. As a result, we explored the possibility with the European regulatory agencies regarding the potential to submit a special marketing approval, or MAA, in the European Union for ATC under the exceptional circumstances pathway, and while we received useful feedback, given our current priorities and resources, we decided in 2014 not to actively pursue such a filing at this time.
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 and drug manufacturing are generally contracted out to third-party, specialty organizations.
Financial Resources
We have experienced net losses every year since our inception and, as of December 31, 2014, had an accumulated deficit of approximately $251,155,000. We expect to incur significant additional operating losses over the next several years, principally as a result of our plans to develop and commercialize fosbretabulin for the treatment of ovarian cancer and neuroendocrine tumors, and OXi4503 for the treatment of AML, continuing and new 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, the exercise of warrants and to a lesser extent the exercise of stock options. We currently have no recurring material amount of income. As of December 31, 2014, we had approximately $30,031,000 in cash. We also raised $10.0 million in gross proceeds, or approximately $9.35 million in net proceeds after deducting placement agents’ fees, and before deducting other offering expenses, in a registered direct offering of common stock and warrants in March 2015, as described in Note 11 to the financial statements.
Currently, we have an “at the market” equity offering sales agreement, or the ATM Agreement, in place for raising additional capital. The ATM Agreement is with MLV & Co. LLC, or MLV, pursuant to which we may issue and sell shares of our common stock from time to time through MLV who will act as our sales agent and underwriter. We are limited as to how many shares we can sell under the ATM Agreement due to limitations imposed by the Securities and Exchange Commission, or the SEC, 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 may be able to sell more shares under this agreement depending on several factors including our stock price, the number of shares of our common stock outstanding as well as the timing of the occurrence of the sales. We will be required to file a new Form S-3 registration statement before June 14, 2015, as our current Form S-3 will be expiring on that date pursuant to SEC rules.
After our financing in March 2015, we expect our existing cash to support our operations through approximately the end of 2017. We expect this level of cash utilization to allow us to advance our ongoing programs, including completion of a Phase 2 clinical trial of fosbretabulin in patients with recurrent GI-NETs with elevated biomarkers including a rollover clinical trial designed to treat patients for one year after they complete the Phase 2 clinical trial if they have responded to fosbretabulin; the initiation and completion of the Phase 1 portion, and initiation of the Phase 2 portion, of an open label clinical trial of OXi4503 in patients with AML to be sponsored by us; and supporting a Phase 1b/2 trial of fosbretabulin in relapsed ovarian cancer in combination with Votrient ® (pazopanib) being sponsored by two UK-based nonprofit organizations. While our existing cash will support the planning for a follow-on clinical program in fosbretabulin for the treatment of
31
ovarian cancer, any significant further clinical development of fosbretabulin in advanced recurrent ovarian cancer, including the potential development of a special protocol assessment with the FDA, and conducting follow-on clinical studies or other capital intensive activities, will be contingent upon our ability to raise additional capital in addition to our existing financing arrangements or from a collaborative research agreement with a third-party, as to which we can give you no assurance.
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.
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 we believe 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.
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 certain input assumptions. We estimate the expected term of options based on an analysis of historical behavior of participants over time. We determine the expected volatility based on the historical volatility of our common stock over a period commensurate with the option’s expected term.
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.
Revenue Recognition
In December 2011, we established a distribution agreement to provide access to fosbretabulin for the treatment of patients with ATC in certain specified territories on a compassionate use basis. The agreement was terminated effective December 31, 2014. The program provided a regulatory mechanism to allow healthcare professionals in the specified territories to prescribe fosbretabulin to individual ATC patients while it was still in
32
development. Our agreement provided that upon the receipt of fosbretabulin by the distributor for distribution and sale to compassionate use patients, the distributor had 30 days to inspect the product for defects and to ensure that the product conforms to the warranties made by us. If the distributor did not notify us of any defective product within the 30-day period it was deemed to have accepted the product. Revenue was recognized based on product accepted at the conclusion of the 30-day inspection period. Also, the distributor paid to us, on a quarterly basis, an amount equal to 20% of the distributor’s gross margin, as defined in the agreement, on its sales of fosbretabulin in the preceding quarter, less the cost of introductory drug provided at no cost. This revenue was recognized upon notification from the distributor of the gross margin earned. Currently, our drug is expensed as manufactured, since it is still in development. As a result, the product provided to the distributor had a zero cost basis, and therefore no cost-of-goods sold has been recorded.
Valuation of preferred stock and warrants
In April 2013, we issued Series A Preferred Stock, Series A Warrants and Series B Warrants in a private placement. The Series A Preferred Stock issued in the offering had a beneficial conversion feature and, as a result, we recognized approximately $2.48 million as a non-cash deemed dividend. In order to calculate the amount of the deemed dividend, we estimated the relative fair value of the Series A Preferred Stock, the Series A Warrants and the Series B Warrants issued in order to determine the amount of the beneficial conversion feature present in the Series A Preferred Stock. The Series A Preferred Stock was valued using Level 2 inputs by reference to the market value of our common stock into which the Series A Preferred Stock was convertible. The Series A Warrants and Series B Warrants granted were valued using the Black-Scholes valuation model and the following Level 3 input assumptions:
|
Weighted Average Assumptions |
April 2013
Private Placement Series A Warrants |
April 2013
Private Placement Series B Warrants |
||||||
|
Risk-free interest rate |
0.24 | % | 0.24 | % | ||||
|
Expected life (years) |
2.3 | 1.9 | ||||||
|
Expected volatility |
87 | % | 87 | % | ||||
|
Dividend yield |
0.00 | % | 0.00 | % | ||||
In September 2013, we issued Series B Preferred Stock and Warrants in a private placement and, using a portion of the proceeds of the private placement, redeemed the remaining outstanding shares of Series A Preferred Stock issued in April 2013. As a result of the redemption, the fair value of the consideration transferred to the holders of the Series B Preferred Stock and the carrying amount of the Series A Preferred Stock were treated as a non-cash deemed dividend to the shareholders of the Series B Preferred Stock. We recognized approximately $2.31 million as a non-cash deemed dividend. In order to calculate the amount of the deemed dividend, we calculated the amount of the consideration transferred to the holders of the Series B Preferred Stock which included the estimated value of the Series B Preferred Stock and Warrants. The fair value of the Series B Preferred Stock was valued using Level 2 inputs by reference to the market value of the Company’s common stock into which the Series B Preferred Stock is convertible. The fair values for the Warrants granted were valued using the Black-Scholes valuation model and the following Level 3 input assumptions:
|
Weighted Average Assumptions |
September 2013
Private Placement Warrants |
|||
|
Risk-free interest rate |
0.24 | % | ||
|
Expected life (years) |
1.9 | |||
|
Expected volatility |
79 | % | ||
|
Dividend yield |
0.00 | % | ||
33
Years ended December 31, 2014, 2013 and 2012
Product revenues
We did not recognize any product revenues for the year ended December 31, 2014, as compared to $95,000 and $156,000 in the years ended December 31, 2013 and 2012, respectively. Product revenues in 2013 and 2012 represent amounts recognized under our distribution agreement with a Danish company which we entered into in December 2011. Product revenues were recognized after delivery of fosbretabulin to the Danish company and the expiration of the 30 day inspection period had expired at which point the drug was deemed accepted. Additionally, in 2012, we recognized approximately $8,000 as revenue for 20% of the distributor’s gross margin, as defined in the agreement, on its sales in the preceding quarter, after the distributor notified us of the amount. The agreement was terminated effective December 31, 2014.
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 provides the amount and percentage change in these components:
| Change | Change | |||||||||||||||||||||||||||
| Years ended December 31, |
2014 versus
2013 |
2013 versus
2012 |
||||||||||||||||||||||||||
| 2014 | 2013 | 2012 | Amount | % | Amount | % | ||||||||||||||||||||||
|
External services |
$ | 5,217 | $ | 2,261 | $ | 1,566 | $ | 2,956 | 131 | % | $ | 695 | 44 | % | ||||||||||||||
|
Employee compensation and related |
1,307 | 890 | 1,250 | 417 | 47 | % | $ | (360 | ) | -29 | % | |||||||||||||||||
|
Employee Stock-based compensation |
194 | 109 | 135 | 85 | 78 | % | $ | (26 | ) | -19 | % | |||||||||||||||||
|
Other |
690 | 376 | 572 | 314 | 84 | % | $ | (196 | ) | -34 | % | |||||||||||||||||
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
Total research and development |
$ | 7,408 | $ | 3,636 | $ | 3,523 | $ | 3,772 | 104 | % | $ | 113 | 3 | % | ||||||||||||||
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|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Research and development expenses increased in the years ended December 31, 2014 and 2013 as compared to the years ended December 31, 2013 and 2012, respectively. In 2014, the increase as compared to 2013 is primarily due to external services costs related to the GI-NET Phase 2 clinical trial that was initiated in 2014 and for the manufacturing of drug product primarily for clinical use and potentially to support any regulatory filings. In 2013, the increase as compared to 2012 is primarily due to external services costs for the manufacturing of drug product for clinical use and potentially to support any regulatory filings.
External services include manufacturing for our drug product for clinical use, manufacturing for our drug product required for regulatory filings, clinical research organizations, clinical site services, labs and other outside services. The cost of drug product is expensed as manufactured and the associated cost can be impacted by the timing of when we need drug product for research and clinical trials and supplying drug for potential regulatory filings. The increase in external services expense in the year ended December 31, 2014 as compared to the year ended December 31, 2013, is primarily attributable to clinical research organization, clinical site services and consulting costs related to the GI-NET Phase 2 clinical trial that was initiated in 2014 and for the manufacturing of drug product for clinical use and potentially to support any regulatory filings. To a lesser extent, the increase in external services is also due to our use of consultant services related to the evaluation of our ovarian cancer program and the results from the GOG-0186I Phase 2 clinical trial in ovarian cancer and planning related to our AML clinical program. The increase in external services expense in the year ended December 31, 2013 as compared to the year ended December 31, 2012, is primarily attributable to costs associated with manufacturing our drug product primarily for clinical use and potentially to support any regulatory filings. The increase in manufacturing expenses in the year ended December 31, 2013 as compared to the year ended December 31, 2012, was offset in part by a decrease in external services due to the completion of the previous clinical trials as referenced above.
Employee compensation and related expenses include employee compensation, incentive compensation, temporary help, employee benefits and travel. In 2014, the increase is primarily attributable to employment of
34
additional research and development personnel and an employee incentive compensation program established in 2014. The reduction in employee compensation and related expenses for the year ended December 31, 2013, as compared to the year ended December 31, 2012, was due to a reduction in clinical employees and related employee costs due to delays in initiating new clinical trials.
Employee stock-based compensation expense increased in the year ended December 31, 2014 as compared to December 31, 2013 and decreased in the year ended December 31, 2013 as compared to the year ended December 31, 2012. The increase in 2014 is primarily due to additional personnel while the decrease in 2013 is due primarily to the reduction in the number of personnel as described above; this amount can also vary significantly from period to period due to the timing and vesting of option grants.
Other expenses include facility expenses and licensing fees and amortization. The increase in other expenses for the year ended December 31, 2014 as compared to the year ended December 31, 2013 is due primarily to licensing fees. The decrease in the year ended December 31, 2013 as compared to the year ended December 31, 2012, is primarily due to a reduction in facilities and related expenses.
Based on our business strategy as outlined in the business section above, we expect research and development expenses to increase in the year ending December 31, 2015 as compared to the year ended December 31, 2014. The costs of our GI-NET clinical program will increase in 2015 as compared to 2014 as we incur costs associated with the Phase 2 clinical trial for an entire year as compared to a partial year in 2014 and incur costs associated with a rollover clinical trial which is designed to treat patients for one year after they complete the Phase 2 clinical trial if they have responded to fosbretabulin. Additionally, we expect to incur costs associated with sponsoring our AML Phase 1/2 clinical trial in-house and closing down the AML Phase 1 trial sponsored by the University of Florida. Therefore, research and development expenses are expected to increase in 2015 as compared to 2014.
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 the amount and percentage change in these components
| Change | Change | |||||||||||||||||||||||||||
| Years ended December 31, |
2014 versus
2013 |
2013 versus
2012 |
||||||||||||||||||||||||||
| 2014 | 2013 | 2012 | Amount | % | Amount | % | ||||||||||||||||||||||
|
Employee compensation and related |
$ | 2,018 | $ | 1,378 | $ | 1,441 | $ | 640 | 46 | % | $ | (63 | ) | -4 | % | |||||||||||||
|
Employee Stock-based compensation |
111 | 389 | 217 | (278 | ) | -71 | % | $ | 172 | 79 | % | |||||||||||||||||
|
Consulting and professional services |
2,410 | 2,205 | 2,117 | 205 | 9 | % | $ | 88 | 4 | % | ||||||||||||||||||
|
Other |
703 | 767 | 915 | (64 | ) | -8 | % | $ | (148 | ) | -16 | % | ||||||||||||||||
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|
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|
|
|
|
|||||||||||||||
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Total general and administrative |
$ | 5,242 | $ | 4,739 | $ | 4,690 | $ | 503 | 11 | % | $ | 49 | 1 | % | ||||||||||||||
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|||||||||||||||
Employee compensation and related expenses increased in the year ended December 31, 2014 as compared to the year ended December 31, 2013, primarily due to severance expense recorded in 2014 related to the departure of an officer and an employee incentive compensation program established in 2014, offset in part by a bonus paid to an officer in 2013 as compensation for income taxes related to a restricted stock grant. Employee compensation and related expenses decreased in the year ended December 31, 2013 as compared to the year ended December 31, 2012, because in 2012 we incurred transition costs related to the consolidation of our Massachusetts administrative offices, including consolidating our finance department, to our California headquarters.
Employee stock-based compensation expense decreased in the year ended December 31, 2014 as compared to the year ended December 31, 2013, and increased in the year ended December 31, 2013 as compared to the year ended December 31, 2012, primarily due to a restricted stock grant to an officer in 2013 valued at $200,000. This amount can also vary significantly from period to period due to the timing and vesting of option grants.
Consulting and professional services expenses increased in the year ended December 31, 2014 as compared to the year ended December 31, 2013, primarily due to marketing research costs and investor relations expenses
35
offset in part by decreases related to legal and accounting fees. Consulting and professional services increased in the year ended December 31, 2013 as compared to the year ended December 31, 2012, due primarily to legal costs associated with financing efforts which were delayed and therefore expensed, and board compensation for increased membership, offset in part by lower consulting costs associated with investor relations and shareholder meeting costs.
Other expense decreased in the year ended December 31, 2014 as compared to the year ended December 31, 2013, primarily due to the decrease of expenditures related to corporate fees such as Delaware franchise tax and transfer agent fees, offset in part by the increase in NASDAQ fees associated with the listing of additional shares, as a result of our February and May 2014 financing transactions and exercises of warrants. Other expenses decreased in the year ended December 31, 2013 as compared to the year ended December 31, 2012 due primarily to a reduction in facility related costs, including insurance, due to the closing of our administrative offices in Massachusetts and the consolidation of our offices in South San Francisco into a smaller space.
We continue to evaluate general and administrative expenses and look for ways to decrease such costs. As discussed above, we have increased our research and development activities in 2014 and expect to increase them further in the 2015 fiscal year, in which case general and administrative expenses could increase in support of research and development activities. As a result, general and administrative expenses in the future could vary significantly from those incurred in the 2014 fiscal year.
Restructuring expenses
We recorded a restructuring charge of $1,226,000 in the year ended December 31, 2011 and recorded net adjustments to the charge of $15,000 in the year ended December 31, 2012. This charge was a result of a restructuring plan announced on September 1, 2011, which included a reduction in work force, and was designed to focus our capital resources on our most promising early-stage clinical programs and further reduce our cash utilization. The restructuring was completed in 2012.
Other Income and Expenses
The table below summarizes the components of Other Income and Expenses for the periods indicated, in thousands:
| Years ended December 31, | ||||||||||||
| 2014 | 2013 | 2012 | ||||||||||
|
Change in fair value of warrants |
$ | — | $ | — | $ | 6 | ||||||
|
Investment income |
6 | 4 | 12 | |||||||||
|
Other (expense) income, net |
(3 | ) | (1 | ) | (25 | ) | ||||||
|
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|
|
|
|
|
|||||||
|
Total |
$ | 3 | $ | 3 | $ | (7 | ) | |||||
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|
|
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|
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We recorded an unrealized (non-cash) gain in the years ended December 31, 2012 as a result of the change in the estimated fair market value of our common stock warrants issued in connection with private placements of shares of our common stock.
Investment income primarily reflects increases and decrease in cash balances due to interest earned on our operating cash accounts.
Other (expense) income primarily reflect foreign exchange gains and losses which can vary depending on exchange rates agreements with foreign vendors and the timing of expenditures.
Tax Matters
At December 31, 2014, we had a net operating loss carry-forward of approximately $224,291,000 for U.S. income tax purposes, which will begin to expire for U.S. purposes in 2020. Due to the degree of uncertainty
36
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 increased by approximately $3,878,000 from the year ended December 31, 2013 to the year ended December 31, 2014 and increased by approximately $2,642,000 from the year ended December 31, 2012 to the year ended December 31, 2013. The increase for both 2013 and 2014 was due primarily to the increase in the federal net operating loss.
LIQUIDITY AND CAPITAL RESOURCES
To date, we have financed our operations principally through net proceeds received from private and public equity financings and through a strategic development arrangement which concluded in 2009. We have experienced negative cash flow from operations each year since our inception, except in the year 2000. As of December 31, 2014, we had an accumulated deficit of approximately $251,155,000. 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 of approximately $30,031,000 at December 31, 2014.
The following table summarizes our cash flow activities for the periods indicated, in thousands:
| Years ended December 31, | ||||||||||||
| 2014 | 2013 | 2012 | ||||||||||
|
Operating activities: |
||||||||||||
|
Net loss |
$ | (12,647 | ) | $ | (8,277 | ) | $ | (8,079 | ) | |||
|
Non-cash adjustments to net loss |
523 | 789 | 632 | |||||||||
|
Changes in operating assets and liabilities |
(27 | ) | 487 | (888 | ) | |||||||
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|
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|
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Net cash used in operating activities |
(12,151 | ) | (7,001 | ) | (8,335 | ) | ||||||
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Investing activities: |
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|
Change in other assets |
(17 | ) | (35 | ) | (8 | ) | ||||||
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|
|||||||
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Net cash used in investing activities |
(17 | ) | (35 | ) | (8 | ) | ||||||
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Financing activities: |
||||||||||||
|
Proceeds from issuance of preferred stock, net of issuance costs |
— | 6,295 | — | |||||||||
|
Proceeds from issuance of common stock, net of issuance costs |
25,682 | 2,800 | 3,317 | |||||||||
|
Proceeds from exercise of warrants into common stock, net of issuance costs |
9,512 | |||||||||||
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|
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|
|||||||
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Net cash provided by financing activities |
35,194 | 9,095 | 3,317 | |||||||||
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|
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Increase (decrease) in cash and cash equivalents |
23,026 | 2,059 | (5,026 | ) | ||||||||
|
Cash and cash equivalents at beginning of period |
7,005 | 4,946 | 9,972 | |||||||||
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Cash and cash equivalents at end of period |
$ | 30,031 | $ | 7,005 | $ | 4,946 | ||||||
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The net cash used in operating activities was $12,151,000 in the year ended December 31, 2014 compared to $7,001,000 in the comparable period in 2013. The net cash used in both periods was primarily attributable to the net losses, adjusted to exclude certain non-cash items, primarily stock based compensation. Net cash used in the 2014 period was also impacted by an increase in accrued compensation offset in part by prepaid expenses related primarily to clinical research organization fees.
The net cash used in operating activities was $7,001,000 in the year ended December 31, 2013 compared to $8,335,000 in the comparable period in 2012. The net cash used in both periods was primarily attributable to the net losses, adjusted to exclude certain non-cash items, primarily stock based compensation. Net cash used in operating activities in the year 2013 was also impacted by an increase in accounts payable, primarily for
37
expenses related to the manufacturing of fosbretabulin. Net cash used in operating activities in the year 2012 was also impacted significantly by the pay down of accounts payable and accrued liabilities, as many of our clinical trial programs were winding down.
Net cash provided by financing activities was $35,194,000 for the year ended December 31, 2014 compared to $9,095,000 in the comparable period in 2013. Net cash provided by financing activities for the year ended December 31, 2014 was primarily attributable to the net proceeds from financing transactions in February and May 2014 and exercises of warrants in 2014, as compared to the financing transactions in 2013, as described below.
Net cash provided by financing activities was $9,095,000 for the year ended December 31, 2013 compared to $3,317,000 in the comparable period in 2012. Net cash provided by financing activities for the year ended December 31, 2013 was primarily attributable to net proceeds from the sale of preferred stock and warrants in private placements in April and September 2013, net of the redemption of a portion of the preferred stock issued in April 2013, and to a lesser extent from the sale of common stock pursuant to the ATM Agreement, as discussed below. Additionally, in the year ended December 31, 2013, we received proceeds from the exercise of our Series B Warrants. Net cash provided by financing activities in the year ended December 31, 2012 was attributable to net proceeds from the sale of common stock pursuant to the LPC Purchase Agreement and ATM Agreement described below.
On May 28, 2014, we closed a financing in which we raised approximately $16,000,000 in gross proceeds or approximately $14,822,000 in net proceeds, after deducting placement agents’ fees and other offering expenses. Investors purchased shares of the Company’s common stock, at a price per share of $2.9625. For each share of common stock purchased, investors received one share of common stock and 0.5 of an unregistered warrant to purchase a share of the Company’s common stock. A total of 5,400,847 shares of common stock were issued and warrants for the purchase of 2,700,424 shares of common stock were issued. The warrants were exercisable immediately after issuance, have a five-year and three-month term, and an exercise price of $2.90 per share. Also, in connection with the offering, we issued to our placement agent and related persons warrants to purchase 216,033 shares of our common stock. The warrants issued to the placement agent and related persons were exercisable immediately after issuance, have an exercise price of $3.7031 per share and terminate on June 14, 2017. The shares of common stock underlying the warrants issued to investors and the placement agent and related persons were subsequently registered pursuant to a registration statement that became effective on June 16, 2014. None of the warrants issued on May 28, 2014 were exercised during the year ended December 31, 2014.
On February 18, 2014, we closed a registered public offering of units of common stock and warrants, in which we raised approximately $12,000,000 in gross proceeds or approximately $10,860,000 in net proceeds after deducting placement agents’ fees and other offering expenses. Investors purchased units, at a price per unit of $2.05, which consisted of one share of common stock and 0.5 of a warrant to purchase a share of our common stock. A total of 5,853,657 shares of common stock were issued and warrants for the purchase of 2,926,829 shares of common stock were issued. The warrants were exercisable immediately after issuance, have a five-year term and an exercise price of $2.75 per share. Also, in connection with the offering, we issued to our placement agent and related persons warrants to purchase 292,682 shares of our common stock, which were exercisable immediately after issuance, have a five-year term and an exercise price of $2.56 per share.
During the year ended December 31, 2014, the investors in the February 2014 public offering exercised 1,054,625 warrants for the purchase of 1,054,625 shares of our common stock for net proceeds of approximately $2,901,000.
On April 16, 2013, we closed an offering pursuant to the terms of a private placement agreement, in which we raised $5,000,000 in gross proceeds, or approximately $4,192,000 in net proceeds after deducting placement agents’ fees and other offering expenses, in a private placement of 5,000 shares of our Series A Preferred Stock. Subject to certain ownership limitations, shares of Series A Preferred Stock were convertible, at the option of the holder thereof, into an aggregate of up to 1,377,412 shares of our common stock. The Series A Preferred Stock was not redeemable or contingently redeemable, did not have a dividend right, nor did it have any preferences over our common stock, including liquidation rights.
38
During the year ended December 31, 2013, the investors in the private placement converted 2,198 shares of Series A Preferred Stock into 605,422 shares of our common stock. In connection with the September 2013 private placement, we agreed to redeem 2,802 shares of Series A Preferred Stock that remained outstanding as of that date, which had a redemption value of approximately $2,802,000, and therefore no shares of Series A Preferred Stock remain outstanding as of December 31, 2013.
Also included in the April 16, 2013 offering were warrants to purchase common stock, as follows:
(A) Series A Warrants to purchase 1,377,412 shares of our common stock, which were exercisable immediately after issuance, have a five-year term and a per share exercise price of $3.40; and
(B) Series B Warrants to purchase 1,377,412 shares of our common stock, which were exercisable immediately after issuance, have a two-year term and a per share exercise price of $3.40.
At the closing on April 16, 2013, we also issued to its placement agent and related persons Series A Warrants to purchase 82,645 shares of our common stock.
During the year ended December 31, 2013, the investors in the private placement exercised 270,390 Series B Warrants into 270,390 shares of our common stock for net proceeds of approximately $864,000. During the year ended December 31, 2014, the investors in the April 2013 private placement exercised 350,000 Series B Warrants for the purchase of 350,000 shares of our common stock for net proceeds of approximately $1,118,000.
On September 23, 2013, we closed another offering pursuant to the terms of a private placement agreement, in which we raised $5,800,000 in gross proceeds, or approximately $4,905,000 in net proceeds after deducting placement agents’ fees and other offering expenses, in a private placement of 5,800 shares of our Series B Preferred Stock. We used the proceeds from this offering in part to redeem the remaining outstanding balance of 2,802 shares of the Series A Preferred Stock, issued in April 2013, for a redemption value of approximately $2,802,000. As a result of the redemption, we recognized approximately $2.31 million as a non-cash deemed dividend in the quarter ended September 30, 2013. After further deducting the amount to redeem the outstanding shares of Series A Preferred Stock, the net proceeds of this offering were approximately $2,103,000.
Subject to certain ownership limitations, shares of Series B Preferred Stock were convertible, at the option of the holder thereof, into an aggregate of up to 2,452,431 shares of our common stock. The Series B Preferred Stock was not redeemable or contingently redeemable, did not have a dividend right, nor did it have any preferences over the common stock, including liquidation rights.
The investors in the private placement converted all of the 5,800 shares of Series B Preferred Stock into 2,452,431 shares of our common stock during the year ended December 31, 2013 and therefore no shares of Series B Preferred Stock remain outstanding as of December 31, 2013.
Also included in the offering were warrants to purchase 2,452,431 shares of our common stock, which were exercisable immediately after issuance, have a five-year term and a per share exercise price of $2.24.
At the closing, we also issued to our placement agent and related persons warrants to purchase 147,145 shares of our common stock, which are exercisable immediately after issuance, have a five-year term and a per share exercise price of $2.80.
During the year ended December 31, 2014, the investors in our September 2013 private placement exercised 2,452,431 warrants for the purchase of 2,452,431 shares of the Company’s common stock for net proceeds of approximately $5,493,000. As of December 31, 2014, no five-year term warrants issued to investors in the September 2013 private placement remain outstanding.
On July 21, 2010, we entered into the ATM Agreement with 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 ATM
39
Agreement. We are limited as to how many shares we can sell pursuant to the ATM Agreement 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. Subject to these restrictions, we may be able to sell more shares under this agreement depending on several factors, including the Company’s stock price, the number of shares of our common stock outstanding and the timing of the occurrence of the sales.
In connection with the ATM Agreement, we issued 422,000 shares of common stock for proceeds of approximately $1,936,000 net of issuance costs, during the year ended December 31, 2013 and issued no shares of common stock under this agreement during the year ended December 31, 2014.
In November 2011, we entered into a purchase agreement (the LPC Purchase Agreement) for the sale, from time to time, of up to $20,000,000 of our common stock to Lincoln Park Capital Fund, LLC or LPC, a Chicago-based institutional investor. This agreement expired January 11, 2015. We did not have the ability to sell shares under this arrangement if we failed to maintain a minimum stock price of $6.00 or if we failed to maintain the effectiveness of a registration statement filed with the SEC. If our stock price rose above $6.00 and the other conditions of the arrangement were met, we could direct LPC to purchase up to $20,000,000 worth of shares of our common stock under our agreement over a 36-month period ending January 11, 2015, in amounts of up to $200,000, which amounts could be increased under certain circumstances. During the term of the LPC Purchase Agreement, we generally controlled the timing and amount of any sales to LPC in accordance with the LPC Purchase Agreement. LPC had no right to require us to sell any shares to LPC, but LPC was obligated to make purchases as we directed, subject to certain conditions, which included 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.
On March 25, 2015, we closed a financing with institutional investors in which we raised approximately $10,000,000 in gross proceeds or approximately $9,350,000 in net proceeds, after deducting placement agents’ fees and before deducting other offering expenses. Investors purchased shares of our common stock, at a price per share of $1.7125. For each share of common stock purchased, investors received one warrant to purchase one half of a share of our common stock. A total of 5,839,420 shares of common stock were issued and warrants for the purchase of 2,919,710 shares of common stock were issued. The warrants are exercisable immediately, expire 5 years from the date of issuance, and have an exercise price of $1.7125 per share. Also, in connection with the offering, we issued to our placement agent and related persons warrants to purchase 233,577 shares of our common stock. The warrants issued to the placement agent and related persons are exercisable immediately after issuance, have an exercise price of $2.13 per share and terminate on June 14, 2017.
The warrants contain limitations that prevent each holder of warrants from acquiring shares upon exercise of the warrants that would cause the number of shares beneficially owned by it and its affiliates to exceed 4.99% of the total number of shares of our common stock then issued and outstanding, provided that, upon prior notice to us, a holder may increase or decrease this limitation provided any increase does not exceed 9.99% of the total number of shares of our common stock then issued and outstanding. In addition, upon certain changes in control of the Company, each holder of a warrant can elect to receive, subject to certain limitations and assumptions, securities in a successor entity. None of the warrants issued on March 25, 2015 have been exercised.
After our financing in March 2015, we expect our existing cash to support our operations through approximately the end of 2017. We expect this level of cash utilization to allow us to continue our ongoing programs, including completion of a Phase 2 clinical trial of fosbretabulin in patients with recurrent GI-NETs with elevated biomarkers, including a rollover clinical trial designed to treat patients for one year after they complete the Phase 2 clinical trial if they have responded to fosbretabulin, the initiation and completion of the Phase 1 portion, and initiation of the Phase 2 portion of an open label clinical trial of OXi4503 in patients with AML to be sponsored by us and supporting a Phase 1b/2 trial of fosbretabulin in relapsed ovarian cancer in combination with Votrient ® (pazopanib) being sponsored by two UK based nonprofit organizations. While our existing cash will support the planning for a follow-on clinical program in fosbretabulin for the treatment of advanced recurrent ovarian cancer, it does not allow for conducting any follow-on clinical studies of fosbretabulin in advanced ovarian cancer. Any significant further development of fosbretabulin or other capital intensive activities will be contingent upon our ability to raise additional capital in addition to the capital available to us under our existing financing arrangements. As of December 31, 2014, we have a balance of
40
unapplied purchase orders for expenditures related to clinical research activities and outsourced drug manufacturing of approximately $4,803,000, of which approximately $92,000 was estimated and accrued at December 31, 2014 for services performed, leaving approximately $4,711,000 to be incurred. Of the $4,711,000 amount to be incurred, we may incur approximately $2,353,000 over the next twelve months.
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 fosbretabulin and OXi4503; the costs of complying with FDA and other regulatory agency 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.
Contractual Obligations
The following table presents information regarding our contractual obligations and commercial commitments as of December 31, 2014 (in thousands):
| 2015 | 2016 | 2017 | 2018 | Thereafter | Total | |||||||||||||||||||
|
Clinical development and related commitments |
$ | 2,353 | $ | 1,480 | $ | 138 | $ | 37 | $ | 24 | $ | 4,032 | ||||||||||||
|
Operating leases |
202 | 209 | 215 | 221 | 112 | 959 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
|
Total contractual obligations |
$ | 2,555 | $ | 1,689 | $ | 353 | $ | 258 | $ | 136 | $ | 4,991 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
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, 2013, we have paid a total of $2,600,000 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 $100,000. We are also required to pay royalties on future net sales of products associated with these patent rights.
41
We also have an exclusive, world-wide, royalty-bearing license from Bristol-Myers Squibb, or BMS, for the commercial development, use and sale of products or services covered by certain patent rights to particular combretastatins, including among others, fosbretabulin. Under the BMS license, we have the right to grant sublicenses. Under the license agreement, BMS is entitled to low-single-digit royalty payments for all commercial sales plus any remuneration OXiGENE receives for sale of fosbretabulin under named patient or compassionate use programs. 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.
| ITEM 7A. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
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 manufacture drugs and conduct trials and studies outside of the United States, we believe our exposure to foreign currency risk to be immaterial.
| 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
| 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 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, 2014, 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, 2014, which 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
42
evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2014 based on the framework in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (1992 Framework) (COSO). Based on that evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2014.
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.
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 we are not an accelerated filer, as defined by Rule 12b-2 of the Exchange Act, 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, 2014 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.
| 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” to be included in the Company’s Proxy Statement for the 2015 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,” to be included in the Company’s Proxy Statement for the 2015 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” “Equity Compensation Plan Information,” and “Proposal 3-Adoption of Equity Compensation Plan” to be included in the Company’s Proxy Statement for the 2015 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” to be included in the Company’s Proxy Statement for the 2015 Annual Meeting of Stockholders.
43
| 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” to be included in the Company’s Proxy Statement for the 2015 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 Schedule
No schedules are submitted because they are not applicable, not required or because the information is included in the Financial Statements as Notes to Financial Statements.
(3) Exhibits
The following is a list of exhibits filed as part of this Annual Report on Form 10-K.
|
Exhibit
|
Description |
|
| 3.1 | Restated Certificate of Incorporation of the Registrant, as amended by Certificates of Amendment dated June 21, 1995, November 14, 1996, July 14, 2005, June 2, 2009, February 8, 2010, August 5, 2010, February 22, 2011, May 29, 2012, December 27, 2012 and July 17, 2013. %%%% | |
| 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 | Form of Series A/B Common Stock Purchase Warrant. @@ | |
| 4.4 | Form of Common Stock Purchase Warrant. && | |
| 4.5 | Form of Common Stock Purchase Warrant. &&& | |
| 4.6 | Form of Placement Agent Purchase Warrant. &&& | |
| 4.7 | Form of 2014 Warrant ££ | |
| 4.8 | Form of 2014 Placement Agent Warrant ££ | |
| 4.9 | Form of Common Stock Purchase Warrant ££££ | |
| 4.10 | Form of Registration Rights Agreement, dated as of May 22, 2014, by and among the Registrant and the purchasers named therein. ££££ | |
| 4.11 | Form of 2015 Common Stock Warrant ¥ | |
| 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. # | |
44
|
Exhibit
|
Description |
|
| 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 | Stockholder Rights Agreement dated as of March 24, 2005, between the Registrant and American Stock Transfer and Trust Company, LLC. !! | |
| 10.11 | Form of Incentive Stock Option Agreement under OXiGENE 2005 Stock Plan. $ @ | |
| 10.12 | Form of Non-Qualified Stock Option Agreement under OXiGENE 2005 Stock Plan. $ @ | |
| 10.13 | Form of Restricted Stock Agreement under OXiGENE 2005 Stock Plan. $ @ | |
| 10.14 | Form of Indemnification Agreement. !!!!! | |
| 10.15 | Lease between Broadway 701 Gateway Fee LLC, A Delaware Limited Liability Company, as Landlord, and the Registrant, as Tenant, dated October 10, 2008. §§§§ | |
| 10.16 | At Market Issuance Sales Agreement, dated July 21, 2010, between OXiGENE, Inc. and McNicoll, Lewis & Vlak LLC. a a | |
| 10.17 | Form of Warrant Exchange Agreement, dated as of January 18, 2011, by and between the Registrant and each Investor named therein. a a a | |
| 10.18 | 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. a a a | |
| 10.19 | OXiGENE, Inc. 2005 Stock Plan (as amended and restated July 16, 2013). x @ | |
| 10.20 | OXiGENE, Inc. Amended and Restated Non-Employee Director Compensation Policy, effective September 20, 2011. xx | |
| 10.21 | Purchase Agreement, dated as of November 28, 2011, by and between the Registrant and Lincoln Park Capital Fund, LLC. xxx | |
| 10.22 | Registration Rights Agreement, dated as of November 28, 2011, by and between the Registrant and Lincoln Park Capital Fund, LLC. xxx | |
| 10.23 | Amended and Restated Employment Agreement, dated as of December 15, 2011, by and between the Registrant and Dr. Peter Langecker. p @ | |
| 10.24 | Employment Agreement by and between the Registrant and Barbara D. Riching dated as of February 2013. ## @ | |
| 10.25 | Amendment No. 1 to At Market Issuance Agreement, dated as of May 31, 2012, by and between the Registrant and McNicoll, Lewis & Vlak LLC. % | |
| 10.26 | Consulting Agreement with David Chaplin, Ph.D., dated as of January 2013. %% | |
| 10.27 | Amendment to Consulting Agreement with David Chaplin, Ph.D., dated as of February 27, 2013. +++ | |
45
|
Exhibit
|
Description |
|
| 10.28 | Letter agreement dated as of April 10, 2013, by and between OXiGENE, Inc. and Dawson James Securities, Inc. @@ | |
| 10.29 | Securities Purchase Agreement, dated as of April 10, 2013, between the Registrant and the purchasers named therein. @@ | |
| 10.30 | Registration Rights Agreement, dated as of April 10, 2013, between the Registrant and the purchasers named therein. @@ | |
| 10.31 | Third Amendment to Lease, dated as of April 1, 2013, by and between the Registrant and DWF III GATEWAY, LLC, a Delaware limited liability company. @@@ | |
| 10.32 | Letter to Stockholders, dated June 27, 2013. p p p p | |
| 10.33 | Letter agreement dated as of September 18, 2013, by and between Registrant and H.C. Wainwright & Co. && | |
| 10.34 | Form of Securities Purchase Agreement dated as of September 18, 2013, by and among Registrant and the purchasers named therein. && | |
| 10.35 | Form of Registration Rights Agreement dated as of September 18, 2013, by and among Registrant and the purchasers named therein. && | |
| 10.36 | Letter agreement dated as of February 11, 2014, by and between OXiGENE, Inc. and H.C. Wainwright & Co., LLC. &&& | |
| 10.37 | Form of Securities Purchase Agreement dated as of February 12, 2014, by and among OXiGENE, Inc. and the purchasers signatory thereto. &&& | |
| 10.38 | License Agreement, dated as of June 14, 2012, by and between the Registrant and Angiogene Pharmaceuticals Ltd. @@@@ $$$$ | |
| 10.39 | Fourth Amendment to Lease, dated April 28, 2014, by and between the Registrant and DWF III Gateway, LLC. £££ | |
| 10.40 | Securities Purchase Agreement, dated as of May 22, 2014, by and among the Registrant and the purchasers named therein. ££££ | |
| 10.41 | Employment Agreement, dated May 16, 2014, by and between the Registrant and David J. Chaplin !!! | |
| 10.42 | Letter Agreement, dated as of May 22, 2014, by and between the Registrant and H.C. Wainwright & Co. ££££ | |
| 10.43 | Securities Purchase Agreement, dated as of March 20, 2015, by and among the Registrant and the purchasers named therein ¥ | |
| 14.1 | Corporate Code of Conduct and Ethics. X | |
| 23.1 | Consent of Independent Registered Public Accounting Firm. 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, 2014 and December 31, 2013: | |
| 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 | ||
46
| * | Incorporated by reference to the Registrant’s Registration Statement on Form S-1 (file no. 33-64968) filed on June 24, 1993, and any amendments thereto. |
| *** | 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 Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2013. |
| + | 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 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. |
| !!!!! | Incorporated by reference to Registrant’s Current Report on Form 8-K, filed October 21, 2008. |
| §§§§ | Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008. |
| a a | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on July 21, 2010. |
| a a a | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on January 19, 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. |
| p | Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011. |
| ## | Incorporated by reference to the Registrant’s Current Report on Form 8-K filed on February 28, 2013. |
| % | Incorporated by reference to the Registrant’s Registration Statement on Form S-3 (file no. 333-181813) filed on May 31, 2012. |
| %% | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on January 23, 2013. |
| +++ | Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012. |
| p p p p | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on July 1, 2013. |
| x | Incorporated by reference to the Registrant’s Registration Statement on Form S-8 (file no. 333-190409) filed on August 8, 2013. |
47
| %%%% | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on July 22, 2013. |
| @@ | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on April 11, 2013. |
| && | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on September 20, 2013. |
| &&& | Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on February 14, 2014. |
| @ | Management contract or compensatory plan or arrangement. |
| @@@@ | Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013 |
| ££ | Incorporated by reference to Registrant’s Registration Statement on Form S-1 (file no. 333-190464) filed on January 31, 2014. |
| £££ | Incorporated by reference to Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2014. |
| !!! | Incorporated by reference to Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2014. |
| ££££ | Incorporated by reference to Registrant’s Current Report on Form 8-K, filed on May 22, 2014. |
| ¥ | Incorporated by reference to Registrant’s Current Report on Form 8-K, filed on March 20, 2015. |
| X | Filed with this report. |
| $$$$ | Confidential treatment has been granted for portions of this Exhibit. Redacted portions filed separately with the Securities and Exchange Commission. |
48
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 / D AVID J. C HAPLIN | |
|
David J. Chaplin Chief Executive Officer |
||
Date: March 30, 2015
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 / D AVID J. C HAPLIN David J. Chaplin |
Chief Executive Officer and Director (Principal executive officer) |
March 30, 2015 | ||
|
/ S / B ARBARA R ICHING Barbara Riching |
Chief Financial Officer (Principal financial and accounting officer) |
March 30, 2015 | ||
|
/ S / F REDERICK W. D RISCOLL Frederick W. Driscoll |
Chairman of the Board and Director |
March 30, 2015 | ||
|
/ S / T AMAR D. H OWSON Tamar D. Howson |
Director |
March 30, 2015 | ||
|
/ S / G ERALD M C M AHON Gerald McMahon |
Director |
March 30, 2015 | ||
|
/ S / W ILLIAM D. S CHWIETERMAN William D. Schwieterman |
Director |
March 30, 2015 | ||
49
Form 10-K Item 15(a)(1)
OXiGENE, Inc.
Index to Financial Statements
The following financial statements of OXiGENE, Inc. are included in Item 8:
| 51 | ||||
| 52 | ||||
| 53 | ||||
| 54 | ||||
| 55 | ||||
| 56 — 70 |
50
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders of
OXiGENE, Inc.
We have audited the accompanying balance sheets of OXiGENE, Inc. as of December 31, 2014 and 2013, and the related statements of comprehensive loss, stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2014. 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 also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and 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 financial position of OXiGENE, Inc. at December 31, 2014 and 2013, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2014, in conformity with U.S. generally accepted accounting principles.
/s/ Ernst & Young LLP
San Jose, California
March 30, 2015
51
OXiGENE, Inc.
(All amounts in thousands,
except per share data)
| December 31, | ||||||||
| 2014 | 2013 | |||||||
|
ASSETS |
||||||||
|
Current assets: |
||||||||
|
Cash |
$ | 30,031 | $ | 7,005 | ||||
|
Prepaid expenses |
318 | 93 | ||||||
|
Other current assets |
4 | 67 | ||||||
|
|
|
|
|
|||||
|
Total current assets |
30,353 | 7,165 | ||||||
|
Property and equipment, net of accumulated depreciation of $242 and $268 at December 31, 2014 and December 31, 2013, respectively |
37 | 36 | ||||||
|
License agreements, net of accumulated amortization of $1,500 and $1,406 at December 31, 2014 and December 31, 2013, respectively |
— | 93 | ||||||
|
Other assets |
33 | — | ||||||
|
|
|
|
|
|||||
|
Total assets |
$ | 30,423 | $ | 7,294 | ||||
|
|
|
|
|
|||||
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
|
Current liabilities: |
||||||||
|
Accounts payable |
$ | 335 | $ | 476 | ||||
|
Accrued compensation and benefits |
841 | 116 | ||||||
|
Accrued research and development |
36 | 317 | ||||||
|
Accrued other |
207 | 342 | ||||||
|
|
|
|
|
|||||
|
Total current liabilities |
1,419 | 1,251 | ||||||
|
Commitments and contingencies |
||||||||
|
Stockholders’ equity: |
||||||||
|
Preferred stock, $.01 par value, 15,000 shares authorized; No shares issued and outstanding |
— | — | ||||||
|
Common stock, $.01 par value, 70,000 shares authorized; 20,705 and 5,586 shares issued and outstanding at December 31, 2014 and December 31, 2013, respectively |
207 | 56 | ||||||
|
Additional paid-in capital |
279,952 | 244,495 | ||||||
|
Accumulated deficit |
(251,155 | ) | (238,508 | ) | ||||
|
|
|
|
|
|||||
|
Total stockholders’ equity |
29,004 | 6,043 | ||||||
|
|
|
|
|
|||||
|
Total liabilities and stockholders’ equity |
$ | 30,423 | $ | 7,294 | ||||
|
|
|
|
|
|||||
See accompanying notes.
52
OXiGENE, Inc.
Statements of Comprehensive Loss
(All amounts in thousands,
except per share data)
| Years ended December 31, | ||||||||||||
| 2014 | 2013 | 2012 | ||||||||||
|
Product revenues |
$ | — | $ | 95 | $ | 156 | ||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
7,408 | 3,636 | 3,523 | |||||||||
|
General and administrative |
5,242 | 4,739 | 4,690 | |||||||||
|
Restructuring (Note 4) |
— | — | 15 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Total operating expenses |
12,650 | 8,375 | 8,228 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Loss from operations |
(12,650 | ) | (8,280 | ) | (8,072 | ) | ||||||
|
Change in fair value of warrants |
— | — | 6 | |||||||||
|
Investment income |
6 | 4 | 12 | |||||||||
|
Other (expense) income, net |
(3 | ) | (1 | ) | (25 | ) | ||||||
|
|
|
|
|
|
|
|||||||
|
Net loss and comprehensive loss |
(12,647 | ) | (8,277 | ) | (8,079 | ) | ||||||
|
Non-cash deemed dividend to preferred stockholders |
— | (4,799 | ) | — | ||||||||
|
|
|
|
|
|
|
|||||||
|
Net loss attributable to common stock |
$ | (12,647 | ) | $ | (13,076 | ) | $ | (8,079 | ) | |||
|
|
|
|
|
|
|
|||||||
|
Basic and diluted net loss per share attributable to common stock |
$ | (0.75 | ) | $ | (4.67 | ) | $ | (5.48 | ) | |||
|
|
|
|
|
|
|
|||||||
|
Weighted-average number of common shares outstanding |
16,973 | 2,803 | 1,473 | |||||||||
|
|
|
|
|
|
|
|||||||
See accompanying notes.
53
OXiGENE, Inc.
Statements of Stockholders’ Equity
(All amounts in thousands)
| Common Stock | Preferred Stock |
Additional
Paid-In Capital |
Accumulated
Deficit |
Total
Equity |
||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | |||||||||||||||||||||||||
|
Balance December 31, 2011 |
1,265 | $ | 13 | — | $ | — | $ | 226,137 | $ | (217,353 | ) | $ | 8,797 | |||||||||||||||
|
Net loss and comprehensive loss |
— | — | — | — | — | (8,079 | ) | (8,079 | ) | |||||||||||||||||||
|
Issuance of common stock under ATM, net of expenses of $137 |
178 | 1 | — | — | 1,269 | — | 1,270 | |||||||||||||||||||||
|
Issuance of common stock to LPC, net of expenses of $552 |
294 | 3 | — | — | 2,044 | — | 2,047 | |||||||||||||||||||||
|
Additional shares due to reverse stock split |
7 | — | — | — | — | — | — | |||||||||||||||||||||
|
Stock based compensation expense |
2 | — | — | — | 511 | — | 511 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
Balance December 31, 2012 |
1,746 | 17 | — | — | 229,961 | (225,432 | ) | 4,546 | ||||||||||||||||||||
|
Net loss and comprehensive loss |
— | — | — | — | — | (8,277 | ) | (8,277 | ) | |||||||||||||||||||
|
Issuance of common stock under ATM, net of expenses of $72 |
422 | 4 | — | — | 1,932 | — | 1,936 | |||||||||||||||||||||
|
Issuance of preferred stock in connection with the private placement, net of expenses of $1,703 |
— | — | 11 | — | 9,097 | — | 9,097 | |||||||||||||||||||||
|
Redemption of preferred stock in connection with the private placement |
— | — | (3 | ) | — | (2,802 | ) | — | (2,802 | ) | ||||||||||||||||||
|
Non-cash deemed dividend to preferred stock in connection with the private placement |
— | — | — | — | 4,799 | (4,799 | ) | — | ||||||||||||||||||||
|
Conversion of preferred stock to common stock |
3,058 | 31 | (8 | ) | — | (31 | ) | — | — | |||||||||||||||||||
|
Issuance of common stock in connection with the exercise of Series B warrants, net of expenses of $55 |
270 | 3 | — | — | 861 | — | 864 | |||||||||||||||||||||
|
Stock based compensation expense |
90 | 1 | — | — | 678 | — | 679 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
Balance December 31, 2013 |
5,586 | 56 | — | — | 244,495 | (238,508 | ) | 6,043 | ||||||||||||||||||||
|
Net loss and comprehensive loss |
— | — | — | — | — | (12,647 | ) | (12,647 | ) | |||||||||||||||||||
|
Issuance of common stock in connection with the public offering, net of expenses of $1,140 |
5,854 | 59 | — | — | 10,801 | — | 10,860 | |||||||||||||||||||||
|
Issuance of common stock in connection with the private placement, net of expenses of $1,178 |
5,401 | 54 | — | — | 14,768 | — | 14,822 | |||||||||||||||||||||
|
Issuance of common stock in connection with the exercise of Series B warrants under Private Placement, net of expenses of $71 |
350 | 3 | — | — | 1,115 | — | 1,118 | |||||||||||||||||||||
|
Issuance of common stock in connection with the exercise of warrants under 2013 Private Placement, net of expenses of $0 |
2,452 | 24 | — | — | 5,469 | — | 5,493 | |||||||||||||||||||||
|
Issuance of common stock in connection with the exercise of warrants under 2014 Public Offering, net of expenses of $0 |
1,055 | 11 | — | — | 2,890 | — | 2,901 | |||||||||||||||||||||
|
Stock based compensation expense |
7 | — | — | — | 414 | — | 414 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
Balance December 31, 2014 |
20,705 | $ | 207 | — | $ | — | $ | 279,952 | $ | (251,155 | ) | $ | 29,004 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
See accompanying notes.
54
OXiGENE, Inc.
(All amounts in thousands)
| Years ended December 31, | ||||||||||||
| 2014 | 2013 | 2012 | ||||||||||
|
Operating activities: |
||||||||||||
|
Net loss |
$ | (12,647 | ) | $ | (8,277 | ) | $ | (8,079 | ) | |||
|
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
|
Change in fair value of warrants |
— | — | (6 | ) | ||||||||
|
Depreciation |
16 | 12 | 29 | |||||||||
|
Amortization of license agreement |
93 | 98 | 98 | |||||||||
|
Stock-based compensation |
414 | 679 | 511 | |||||||||
|
Changes in operating assets and liabilities: |
||||||||||||
|
Restricted cash |
20 | — | ||||||||||
|
Prepaid expenses and other current assets |
(195 | ) | 117 | 464 | ||||||||
|
Accounts payable and accrued expenses |
168 | 350 | (1,352 | ) | ||||||||
|
|
|
|
|
|
|
|||||||
|
Net cash used in operating activities |
(12,151 | ) | (7,001 | ) | (8,335 | ) | ||||||
|
|
|
|
|
|
|
|||||||
|
Investing activities: |
||||||||||||
|
Purchases of furniture, fixtures, equipment and other assets |
(17 | ) | (35 | ) | (8 | ) | ||||||
|
|
|
|
|
|
|
|||||||
|
Net cash used in investing activities |
(17 | ) | (35 | ) | (8 | ) | ||||||
|
|
|
|
|
|
|
|||||||
|
Financing activities: |
||||||||||||
|
Proceeds from issuance of preferred stock, net of issuance costs |
— | 6,295 | — | |||||||||
|
Proceeds from issuance of common stock, net of issuance costs |
25,682 | 1,936 | 3,317 | |||||||||
|
Proceeds from exercise of warrants into common stock, net of issuance costs |
9,512 | 864 | — | |||||||||
|
|
|
|
|
|
|
|||||||
|
Net cash provided by financing activities |
35,194 | 9,095 | 3,317 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Increase (decrease) in cash and cash equivalents |
23,026 | 2,059 | (5,026 | ) | ||||||||
|
Cash at beginning of period |
7,005 | 4,946 | 9,972 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Cash at end of period |
$ | 30,031 | $ | 7,005 | $ | 4,946 | ||||||
|
|
|
|
|
|
|
|||||||
|
Non-Cash investing and financing activities: |
||||||||||||
|
Conversion of preferred stock to common stock |
$ | — | $ | 7,998 | $ | — | ||||||
|
Redemption of preferred stock in connection with the private placement |
$ | — | $ | 2,802 | $ | — | ||||||
|
Non-cash deemed dividend to preferred stock |
$ | — | $ | 4,799 | $ | — | ||||||
See accompanying notes.
55
OXiGENE, INC.
December 31, 2014
1. Description of Business and Significant Accounting Policies
Description of Business
OXiGENE, Inc. (the “Company”), is incorporated in the state of Delaware, and is a clinical-stage, biopharmaceutical company developing novel therapeutics primarily to treat cancer. The Company’s major focus is developing vascular disrupting agents (VDAs) that selectively disrupt abnormal blood vessels associated with solid tumor progression. The Company is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients. The Company has two VDA drug candidates currently being tested in clinical trials, fosbretabulin and OXi4503.
Capital Resources
The Company has experienced net losses every year since inception and, as of December 31, 2014, had an accumulated deficit of approximately $251,155,000 the Company expects to incur significant additional operating losses over at least the next several years, principally as a result of the Company’s continuing clinical trials and anticipated research and development expenditures. The principal source of the Company’s 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. The Company currently has no recurring material amount of income. As of December 31, 2014, the Company had approximately $30,031,000 in cash. The company also raised $10.0 million in gross proceeds, or approximately $9.35 million in net proceeds after deducting placement agents’ fees, and before deducting other offering expenses, in a registered direct offering of common stock and warrants in March 2015, as described in Note 11 to the financial statements.
The Company expects its existing cash to support its operations through approximately the end of 2017. The Company expects this level of cash utilization to allow it to continue its ongoing programs, including completion of a Phase 2 clinical trial of fosbretabulin in patients with recurrent GI-NETs with elevated biomarkers, including a rollover clinical trial designed to treat patients for one year after they complete the Phase 2 clinical trial if they have responded to fosbretabulin, the initiation and completion of the Phase 1 portion, and initiation of the Phase 2 portion, of an open label clinical trial of OXi4503 in patients with AML to be sponsored by the Company; and supporting a Phase 1b/2 trial of fosbretabulin in relapsed ovarian cancer in combination with Votrient ® (pazopanib), being sponsored by two UK-based nonprofit organizations. While the Company’s existing cash will support the planning for a follow-on clinical program in fosbretabulin for the treatment of ovarian cancer, any significant further development of fosbretabulin in advanced recurrent ovarian cancer, including the potential development of a special protocol assessment with the FDA, and conducting follow-on clinical studies or other capital intensive activities, will be contingent upon the Company’s ability to raise additional capital in addition to its existing financing arrangements or from a collaborative research agreement with a third-party, as to which the Company can give no assurance.
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, would most likely be dilutive to its current stockholders and debt financing, if available, and 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 it is unable to comply with the listing standards of The NASDAQ Capital Market and instead has to trade its common shares in the over-the-counter market.
56
OXiGENE, INC.
Notes to Financial Statements — (Continued)
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. The Company holds its cash and cash equivalents at one financial institution.
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 the Company’s 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, 2014 and 2013, the Company did not hold any assets or liabilities subject to measurement on a recurring basis. The Company was required to measure, on a non-recurring basis, the fair value of its convertible preferred stock and warrants issued in the April 2013 and September 2013 financing transactions. The methods and assumptions used to value those instruments are disclosed in Note 6 to the financial statements.
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.
License Agreements
The carrying value of the license agreement with Arizona State University (ASU) was amortized over the term of the agreement, which was approximately 15.5 years (see Note 3), and now has a carrying value of $0. The technology licensed from ASU is related to the Company’s fosbretabulin and OXi4503 programs. 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. Both the fosbretabulin and OXi4503 programs utilize intellectual property under the license agreement, demonstrating alternative future use in other research and development projects. 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.
57
OXiGENE, INC.
Notes to Financial Statements — (Continued)
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.
Revenue Recognition
In December 2011, the Company established a distribution agreement to provide access to fosbretabulin for the treatment of patients with ATC in certain specified territories on a compassionate use basis. This agreement was terminated effective December 31, 2014. The agreement provided that upon the receipt of fosbretabulin by the distributor for distribution and sale to compassionate use patients, the distributor had 30 days to inspect the product for defects and to ensure that the product conformed to the warranties made by the Company. If the distributor did not notify the Company of any defective products within the 30-day period it was deemed to have accepted the products. Revenue was recognized based on products being accepted at the conclusion of the 30-day inspection period. Also, the distributor was obligated to pay to the Company, on a quarterly basis, an amount equal to 20% of the distributor’s gross margin, as defined in the agreement, on its sales of fosbretabulin in the preceding quarter, less the cost of introductory drug provided at no cost. This revenue was recognized upon notification from the distributor of the gross margin earned. Fosbretabulin was expensed at the time it was manufactured, because it is in the development stage and there was not an alternative future use. As a result, the product provided to the distributor has a zero cost basis, and therefore no cost-of-goods-sold has been recorded.
Comprehensive Net Loss
For the periods presented, there are no components of other comprehensive income or accumulated comprehensive income and net loss is equal to comprehensive loss.
Stock-based Compensation
The Company expenses the estimated fair value of all share-based payments issued to employees on a straight-line basis 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”) which was suspended in 2012.
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.
58
OXiGENE, INC.
Notes to Financial Statements — (Continued)
Income Taxes
The Company accounts for income taxes based upon the provisions of ASC 740, Income 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 (in thousands):
| Years ended December 31, | ||||||||
| 2014 | 2013 | |||||||
|
Leasehold improvements |
$ | 6 | $ | 6 | ||||
|
Equipment |
237 | 262 | ||||||
|
Furniture and fixtures |
36 | 36 | ||||||
|
|
|
|
|
|||||
|
Total gross assets |
279 | 304 | ||||||
|
Less accumulated depreciation |
(242 | ) | (268 | ) | ||||
|
|
|
|
|
|||||
|
Total furniture and fixtures, equipment and leasehold improvements |
$ | 37 | $ | 36 | ||||
|
|
|
|
|
|||||
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, 2014, the Company has paid a total of $2,600,000 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 amortized this amount over the patent life or 15.5 years.
The Company has recorded all amortization expense related to this license agreement of approximately $1,500,000 as of December 31, 2014. The net book value at December 31, 2014 and 2013 was $0 and $93,000, respectively.
59
OXiGENE, INC.
Notes to Financial Statements — (Continued)
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 development restructuring expenses and approximately $505,000 of general and administrative restructuring expenses in the year ended December 31, 2011. In the year ended December 31, 2012, the Company made net adjustments to the accrual of approximately $15,000. Activities under the 2011 restructuring plan were complete as of November 2012.
|
Amounts
Paid |
Foreign
Currency Adjust- ment |
Amount
Accrued |
Amounts
Paid |
Adjust-
ment |
Foreign
Currency Adjust- ment |
Amount
Accrued |
||||||||||||||||||||||||||||||||||
|
Original
Charges |
Adjust-
ment |
Charges
to date |
Years ended December 31, | |||||||||||||||||||||||||||||||||||||
| 2011 | 2012 | |||||||||||||||||||||||||||||||||||||||
|
G&A |
$ | 425 | $ | 80 | $ | 505 | $ | (373 | ) | $ | — | $ | 132 | $ | (152 | ) | $ | 20 | $ | — | $ | — | ||||||||||||||||||
|
R&D |
721 | 721 | (178 | ) | (22 | ) | 521 | (526 | ) | (5 | ) | 10 | — | |||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Total restructuring |
$ | 1,146 | $ | 80 | $ | 1,226 | $ | (551 | ) | $ | (22 | ) | $ | 653 | $ | (678 | ) | $ | 15 | $ | 10 | $ | — | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
5. Accrued Other
Accrued other consisted of the following at the dates indicated below (in thousands):
| Years ended December 31, | ||||||||
| 2014 | 2013 | |||||||
|
Accounting and Legal |
$ | 179 | $ | 154 | ||||
|
Deferred Rent |
$ | 21 | $ | — | ||||
|
Other |
7 | 188 | ||||||
|
|
|
|
|
|||||
|
Total accrued other |
$ | 207 | $ | 342 | ||||
|
|
|
|
|
|||||
6. Stockholders’ Equity – Common and Preferred Shares
As of December 31, 2014 and 2013 the Company has 70,000,000 common stock authorized.
Registered Offering of Common Stock and Private Placement of Warrants
On May 28, 2014, the Company closed a financing in which it raised approximately $16,000,000 in gross proceeds or approximately $14,822,000 in net proceeds, after deducting placement agents’ fees and other offering expenses. Investors purchased shares of the Company’s common stock, at a price per share of $2.9625. For each share of common stock purchased, investors received one share of common stock and 0.5 of an unregistered warrant to purchase a share of the Company’s common stock. A total of 5,400,847 shares of common stock were issued and warrants for the purchase of 2,700,424 shares of common stock were issued. The warrants were exercisable immediately after issuance, have a five-year and three-month term, and an exercise price of $2.90 per share. Also, in connection with the offering, the Company issued to its placement agent and related persons warrants to purchase 216,033 shares of the Company’s common stock. The warrants issued to the placement agent and related persons were exercisable immediately after issuance, have an exercise price of $3.7031 per share and terminate on June 14, 2017. The shares of common stock underlying the warrants issued to investors and the placement agent and related persons were subsequently registered pursuant to a registration statement that became effective on June 16, 2014.
60
OXiGENE, INC.
Notes to Financial Statements — (Continued)
The warrants contain limitations that prevent each holder of warrants from acquiring shares upon exercise of the warrants that would cause the number of shares beneficially owned by it and its affiliates to exceed 4.99% of the total number of shares of the Company’s common stock then issued and outstanding, provided that, upon prior notice to the Company, a holder may increase or decrease this limitation provided any increase does not exceed 9.99% of the total number of shares of our common stock then issued and outstanding. In addition, upon certain changes in control of the Company, each holder of a warrant can elect to receive, subject to certain limitations and assumptions, securities in a successor entity. None of the warrants issued on May 28, 2014 were exercised during the year ended December 31, 2014.
Public Offering of Common Stock and Warrants
On February 18, 2014, the Company closed a registered public offering of units of common stock and warrants, in which the Company raised approximately $12,000,000 in gross proceeds or approximately $10,860,000 in net proceeds, after deducting placement agents’ fees and other offering expenses. Investors purchased units, at a price per unit of $2.05, which consisted of one share of common stock and 0.5 of a warrant to purchase a share of the Company’s common stock. A total of 5,853,657 shares of common stock were issued and warrants for the purchase of 2,926,829 shares of common stock were issued. The warrants were exercisable immediately after issuance, have a five-year term and an exercise price of $2.75 per share. Also, in connection with the offering, the Company issued to its placement agent and related persons warrants to purchase 292,682 shares of the Company’s common stock, which were exercisable immediately after issuance, have a five-year term and an exercise price of $2.56 per share.
The warrants issued to the investors and the placement agent and related persons contain limitations that prevent each holder of the warrants from acquiring shares upon exercise of the warrants that would result in the number of shares beneficially owned by it and its affiliates exceeding 9.99% of the total number of shares of the Company’s common stock then issued and outstanding. In addition, upon certain changes in control of the Company, each holder of a warrant can elect to receive, subject to certain limitations and assumptions, securities in a successor entity.
During the year ended December 31, 2014, the investors in the February 2014 public offering exercised 1,054,625 warrants for the purchase of 1,054,625 shares of the Company’s common stock for net proceeds of approximately $2,901,000.
Private Placements of Preferred Shares and Warrants
April 2013 Private Placement
On April 16, 2013, the Company closed an offering pursuant to the terms of a private placement agreement, in which the Company raised $5,000,000 in gross proceeds, or approximately $4,192,000 in net proceeds after deducting placement agents’ fees and other offering expenses, in a private placement of 5,000 shares of the Company’s Series A Preferred Stock (the “Series A Preferred Stock”). Subject to certain ownership limitations, shares of Series A Preferred Stock were convertible, at the option of the holder thereof, into an aggregate of up to 1,377,412 shares of the Company’s common stock. The Series A Preferred Stock was not redeemable or contingently redeemable, did not have a dividend right, nor did it have any preferences over the common stock, including any preferential liquidation rights.
During the year ended December 31, 2013, the investors in the private placement converted 2,198 shares of Series A Preferred Stock into 605,422 shares of the Company’s common stock. In connection with the September 2013 private placement described below, the Company agreed to redeem 2,802 shares of Series A Preferred Stock that remained outstanding as of that date, which had a redemption value of approximately $2,802,000, and therefore no shares of Series A Preferred Stock remain outstanding as of December 31, 2013. See below under September 2013 Private Placement.
61
OXiGENE, INC.
Notes to Financial Statements — (Continued)
Also included in the April 16, 2013 offering were warrants to purchase common stock, as follows:
(A) Warrants to purchase 1,377,412 shares of the Company’s common stock, which were exercisable immediately after issuance, have a five-year term and a per share exercise price of $3.40 (the “Series A Warrants”); and
(B) Warrants to purchase 1,377,412 shares of the Company’s common stock, which were exercisable immediately after issuance, have a two-year term and a per share exercise price of $3.40 (the “Series B Warrants”).
At the closing on April 16, 2013, the Company also issued to its placement agent and related persons Series A Warrants to purchase 82,645 shares of the Company’s common stock.
During the year ended December 31, 2013, the investors in the April 2013 private placement exercised 270,390 Series B Warrants for the purchase of 270,390 shares of the Company’s common stock for net proceeds of approximately $864,000. During the year ended December 31, 2014, the investors in the April 2013 private placement exercised 350,000 Series B Warrants into 350,000 shares of the Company’s common stock for net proceeds of approximately $1,118,000.
The Series A Preferred Stock issued in the offering had a beneficial conversion feature and, as a result, the Company recognized approximately $2.48 million as a non-cash deemed dividend in the quarter ended June 30, 2013. In order to calculate the amount of the deemed dividend, the Company estimated the relative fair value of the Series A Preferred Stock, the Series A Warrants and the Series B Warrants issued in order to determine the amount of the beneficial conversion feature present in the Series A Preferred Stock. The Series A Preferred Stock was valued using Level 2 inputs by reference to the market value of the Company’s common stock into which the Series A Preferred Stock is convertible. The Series A Warrants and Series B Warrants granted were valued using the Black-Scholes valuation model and the following Level 3 input assumptions:
|
Weighted Average Assumptions |
April 2013
Private Placement Series A Warrants |
April 2013
Private Placement Series B Warrants |
||||||
|
Risk-free interest rate |
0.24 | % | 0.24 | % | ||||
|
Expected life (years) |
2.3 | 1.9 | ||||||
|
Expected volatility |
87 | % | 87 | % | ||||
|
Dividend yield |
0.00 | % | 0.00 | % | ||||
September 2013 Private Placement
On September 23, 2013, the Company closed an offering pursuant to the terms of a private placement agreement, in which the Company raised $5,800,000 in gross proceeds, or approximately $4,905,000 in net proceeds after deducting placement agents’ fees and other offering expenses, in a private placement of 5,800 shares of the Company’s Series B Preferred Stock (the “Series B Preferred Stock”). The Company used the proceeds of this offering in part to redeem the remaining outstanding balance of 2,802 shares of the Series A Preferred Stock, issued in April 2013, for a redemption value of approximately $2,802,000. After further deducting the amount to redeem the outstanding shares of Series A Preferred Stock, the net proceeds of this offering were approximately $2,103,000.
Subject to certain ownership limitations, shares of Series B Preferred Stock were convertible, at the option of the holder thereof, into an aggregate of up to 2,452,431 shares of the Company’s common stock. The Series B Preferred Stock was not redeemable or contingently redeemable, did not have a preferential dividend right, nor did it have any preferences over the common stock, including liquidation rights.
The investors in the private placement converted all of the 5,800 shares of Series B Preferred Stock into 2,452,431 shares of our common stock during the year ended December 31, 2013 and therefore no shares of Series B Preferred Stock remain outstanding as of December 31, 2014.
62
OXiGENE, INC.
Notes to Financial Statements — (Continued)
Also included in the offering were warrants to purchase 2,452,431 shares of the Company’s common stock, which were exercisable immediately after issuance, have a five-year term and a per share exercise price of $2.24.
At the closing, the Company also issued to its placement agent and related persons warrants to purchase 147,145 shares of the Company’s common stock, which are exercisable immediately after issuance, have a five-year term and a per share exercise price of $2.80.
During the year ended December 31, 2014, the investors in the September 2013 private placement exercised 2,452,431 warrants for the purchase of 2,452,431 shares of the Company’s common stock for net proceeds of approximately $5,493,000. As of December 31, 2014, no five-year term warrants issued to investors in the September 2013 private placement remain outstanding.
As a result of the Company’s redemption of the outstanding balance of the Series A Preferred Stock, the excess of the fair value of the consideration transferred to the holders of the Series B Preferred Stock over the carrying amount of the Series A Preferred Stock in the Company’s balance sheet (net of issuance costs) was treated as a non-cash deemed dividend to the shareholders of the Series B Preferred Stock. The Company recognized approximately $2.31 million as a non-cash deemed dividend in the quarter ended September 30, 2013. In order to calculate the amount of the deemed dividend, the Company first calculated the amount of the consideration transferred to the holders of the Series B Preferred Stock which included the cash used to redeem the Series A Preferred Stock, and the estimated value of the Series B Preferred Stock and warrants. The Series B Preferred Stock was valued using Level 2 inputs by reference to the market value of the Company’s common stock into which the Series B Preferred Stock is convertible. The warrants granted were valued using the Black-Scholes valuation model and the following Level 3 input assumptions:
|
Weighted Average Assumptions |
September 2013
Private Placement Warrants |
|||
|
Risk-free interest rate |
0.24 | % | ||
|
Expected life (years) |
1.9 | |||
|
Expected volatility |
79 | % | ||
|
Dividend yield |
0.00 | % | ||
At The Market Agreement and Purchase Agreement for the sale of common stock
On July 21, 2010, the Company entered into an “at the market” equity offering sales agreement (the “ATM Agreement”) with MLV & Co. LLC ( “MLV”), pursuant to which the Company may issue and sell shares of its common stock from time to time through MLV acting as sales agent and underwriter. The Company is limited as to how many shares it can sell under the ATM Agreement 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 may be able to sell more shares under this agreement depending on several factors including the Company’s stock price, number of shares outstanding, and when the sales occur. The Company will be required to file a new Form S-3 registration statement before June 14, 2015, as its current Form S-3 will be expiring on that date pursuant to SEC rules. In addition, the Company is restricted for 90 days under the terms of its last financing which closed on March 25, 2015, and in the future it may be restricted by the terms of other financing arrangements that it may enter into from making sales under the ATM Agreement.
In connection with the ATM Agreement, the Company issued approximately 422,000 shares of common stock for proceeds of approximately $1,936,000 net of issuance costs, during the year ended December 31, 2013. Additionally, the Company issued approximately 178,000 shares of common stock for proceeds of approximately $1,270,000 net of issuance costs, during the year ended December 31, 2012. No shares of common stock were issued under this agreement during the year ended December 31, 2014.
63
OXiGENE, INC.
Notes to Financial Statements — (Continued)
In November 2011, the Company entered into a purchase agreement (the “LPC Purchase Agreement”) for the sale, from time to time, of up to $20,000,000 of its common stock to Lincoln Park Capital Fund, LLC (“LPC”), which expired on January 11, 2015. The Company could only sell shares under this arrangement if it maintained a minimum stock price of $6.00. The facility has expired pursuant to its terms and accordingly is no longer available to the Company.
In connection with the LPC Purchase Agreement, the Company issued 294,000 shares of common stock for proceeds of approximately $2,047,000, net of issuance costs, during the year ended December 31, 2012, including 6,493 shares issued as a commitment fee. No shares of common stock were issued under this agreement during the year ended December 31, 2013 or 2014.
Warrants
The following is a summary of the Company’s outstanding common stock warrants as of December 31, 2014 and December 31, 2013:
|
Number of Warrants
as of December 31, |
||||||||||||||||||
|
Date
of
Issuance |
Warrant Term |
Exercise
Price |
(In thousands) | |||||||||||||||
|
Warrants Issued in Connection with: |
2014 | 2013 | ||||||||||||||||
|
Direct Registration Series I Warrants |
07/20/09 | 5years | $ | 504.00 | — | 12 | ||||||||||||
|
Private Placement Series A Warrants |
04/16/13 | 5years | $ | 3.40 | 1,460 | 1,460 | ||||||||||||
|
Private Placement Series B Warrants |
04/16/13 | 2years | $ | 3.40 | 757 | 1,107 | ||||||||||||
|
2013 Private Placement Warrants |
09/23/13 | 5years | $ | 2.24 | — | 2,452 | ||||||||||||
|
2013 Private Placement Warrants |
09/23/13 | 5years | $ | 2.80 | 147 | 147 | ||||||||||||
|
2014 Public Offering Warrants |
02/18/14 | 5years | $ | 2.75 | 1,872 | — | ||||||||||||
|
2014 Public Offering Warrants |
02/18/14 | 5years | $ | 2.56 | 293 | — | ||||||||||||
|
2014 Private Placement Warrants |
05/28/14 | 5 years & 3 months | $ | 2.90 | 2,700 | — | ||||||||||||
|
2014 Private Placement Warrants |
05/28/14 | 5 years & 3 months | $ | 3.7031 | 216 | — | ||||||||||||
|
|
|
|
|
|||||||||||||||
|
Total Warrants Outstanding |
7,445 | 5,178 | ||||||||||||||||
|
|
|
|
|
|||||||||||||||
Options and restricted stock
The Company’s 2005 Stock Plan, as amended at the 2012 Annual Meeting of Stockholders in May 2012 (the “2005 Plan”) provides for the award of options, restricted stock and stock appreciation rights to acquire up to 833,333 shares of the Company’s common stock in the aggregate. 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.
64
OXiGENE, INC.
Notes to Financial Statements — (Continued)
The following is a summary of the Company’s stock option activity under its 2005 Plan for the years ended December 31, 2012, 2013 and 2014:
| Shares |
Weighted
Average Exercise Price |
Weighted
Average Remaining Contractual Life |
Aggregate
Intrinsic Value |
|||||||||||||
| (In thousands) | (Years) | (In thousands) | ||||||||||||||
|
Options outstanding at December 31, 2011 |
83 | $ | 70.06 | 9.23 | ||||||||||||
|
Granted |
124 | $ | 9.83 | |||||||||||||
|
Forfeited and expired |
(64 | ) | $ | 66.21 | ||||||||||||
|
|
|
|||||||||||||||
|
Options outstanding at December 31, 2012 |
143 | $ | 19.73 | 8.64 | ||||||||||||
|
Granted |
107 | $ | 3.90 | |||||||||||||
|
Forfeited and expired |
(58 | ) | $ | 14.38 | ||||||||||||
|
|
|
|||||||||||||||
|
Options outstanding at December 31, 2013 |
192 | $ | 12.54 | 7.61 | ||||||||||||
|
Granted |
521 | $ | 2.67 | |||||||||||||
|
Forfeited and expired |
(41 | ) | $ | 33.40 | ||||||||||||
|
|
|
|||||||||||||||
|
Options outstanding at December 31, 2014 |
672 | $ | 3.63 | 8.49 | $ | — | ||||||||||
|
|
|
|||||||||||||||
|
Options exercisable at December 31, 2014 |
244 | $ | 4.51 | 7.15 | $ | — | ||||||||||
|
Options vested or expected to vest at December 31, 2014 |
565 | $ | 3.73 | 8.34 | $ | — | ||||||||||
As of December 31, 2014 there was approximately $515,000 of unrecognized compensation cost related to stock option awards that is expected to be recognized as expense over a weighted average period of approximately 2.68 years.
The following stock options were granted during the years ended December 31, 2014, 2013 and 2012:
| Years ended December 31, | ||||||||||||
| 2014 | 2013 | 2012 | ||||||||||
|
Options Granted (In thousands) |
521 | 107 | 124 | |||||||||
|
Weighted average fair value |
$ | 1.87 | $ | 2.77 | $ | 6.94 | ||||||
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, 2014, 2013 and 2012:
| Years ended December 31, | ||||||||||||
|
Weighted Average Assumptions |
2014 | 2013 | 2012 | |||||||||
|
Risk-free interest rate |
1.55 | % | 0.95 | % | 0.85 | % | ||||||
|
Expected life (years) |
4 | 4 | 4 | |||||||||
|
Expected volatility |
99 | % | 100 | % | 102 | % | ||||||
|
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, |
65
OXiGENE, INC.
Notes to Financial Statements — (Continued)
| Ÿ |
the grant date price of the Company’s common stock, which is issuable upon exercise of the option, |
| Ÿ |
the expected volatility of the Company’s common stock, |
| Ÿ |
the expected dividends on the Company’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 the Company’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. The Company 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 the Company 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, the Company 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.
The Company recorded expenses of $20,000, $259,913 and $0 during the years ended December 31, 2014, 2013 and 2012, respectively, related to restricted stock awards granted from the Company’s 2005 Stock Plan. In 2013 an officer was granted a restricted stock award of 72,933 shares valued at $199,913 as compensation and all other grants of restricted stock were granted to board of directors as board compensation The restricted stock awards were valued based on the closing price of the Company’s common stock on the grant date and the shares were fully vested upon grant.
As of December 31, 2014, the Company did not have any non-vested restricted common stock outstanding.
Employee Stock Purchase Plan (2009 ESPP)
The Company has an Employee Stock Purchase Plan which was suspended in 2012. 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 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 10,417 shares of common stock may be issued under the 2009 ESPP, subject to adjustment each year pursuant to the terms of the 2009 ESPP.
7. Net Loss Per Share
Basic and diluted net loss per share was calculated by dividing the net loss per share attributed to the Company’s common shares by the weighted-average number of common shares outstanding. Diluted net loss per
66
OXiGENE, INC.
Notes to Financial Statements — (Continued)
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 672,000, 192,000, and 143,000 stock options and 7,445,000, 5,178,000, and 13,000 warrants at December 31, 2014, 2013 and 2012, respectively, were excluded from the calculation of weighted average shares for diluted net loss per share.
8. Income Taxes
The components of the Company’s deferred tax assets at December 31, 2014 and 2013 are as follows: (Amounts in thousands):
| Years ended December 31, | ||||||||
| 2014 | 2013 | |||||||
|
Net operating loss carryforwards |
$ | 79,194 | $ | 74,533 | ||||
|
Research and development credits |
2,301 | 2,171 | ||||||
|
Stock based compensation |
667 | 434 | ||||||
|
Capital loss carryforwards |
— | 1,360 | ||||||
|
Accruals and reserves |
297 | 83 | ||||||
|
|
|
|
|
|||||
|
Total Deferred tax assets |
82,459 | 78,581 | ||||||
|
|
|
|
|
|||||
|
Valuation allowance |
(82,459 | ) | (78,581 | ) | ||||
|
|
|
|
|
|||||
|
Net deferred tax asset |
$ | — | $ | — | ||||
|
|
|
|
|
|||||
After consideration of the available evidence, both positive and negative, the Company has determined that a full valuation allowance at December 31, 2014 and 2013, is necessary to reduce the deferred tax assets to the amount that will more likely than not be realized. The valuation allowance increased by approximately $3,878,000 and $2,642,000 for the years ended December 31, 2014 and 2013, respectively. The increase for both 2013 and 2014 was due primarily to the increase in the federal net operating loss.
At December 31, 2014, the Company had net operating loss carry-forwards of approximately $224,291,000 for U.S. income tax purposes, which will begin to expire in 2020 and state operating loss carry-forwards of $55,365,000 in California that will begin to expire in 2017. The Company also had tax credits of $2,491,000 related to federal research and development activities which begin to expire in 2021. The Company also had tax credits of $873,000 related to state research and development activities which have no expiration. The Company recorded a capital loss carryover of approximately $4,000,000 in 2009 that generated a deferred tax asset of $1,360,000, which have expired at the end of 2014 since not utilized.
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 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 financial statements.
67
OXiGENE, INC.
Notes to Financial Statements — (Continued)
A reconciliation of the federal statutory rate to the Company’s effective tax rate is as follows:
|
Years ended
December 31, |
||||||||
| 2014 | 2013 | |||||||
|
Federal Statutory Rate |
34.00 | % | 34.00 | % | ||||
|
State Income taxes |
— | 0.31 | ||||||
|
Federal NOL adjustment |
— | (0.48 | ) | |||||
|
Permanent Items: Capital Loss |
(10.82 | ) | — | |||||
|
Permanent Items |
— | 0.16 | ||||||
|
Stock Compensation |
(0.05 | ) | (0.31 | ) | ||||
|
Federal Research Credits |
0.71 | 1.64 | ||||||
|
State rate change |
6.82 | (3.38 | ) | |||||
|
Miscellaneous |
— | (0.03 | ) | |||||
|
(Increase)/ Decrease in Valuation Allowance |
(30.66 | ) | (31.91 | ) | ||||
|
|
|
|
|
|||||
|
Provision for income taxes |
— | % | — | % | ||||
|
|
|
|
|
|||||
ASC 740-10-50 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 740-10-50 also provides guidance on de-recognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. At December 31, 2014, the Company had unrecognized tax benefits of $797,869 related to research and development credits and $295,038 related to California 2013 net operating losses.
The change in unrecognized tax benefits from December 31, 2012 is as follows:
|
Unrecognized tax benefits as of 12/31/12 |
$ | 673,880 | ||
|
Increase in prior year unrecognized tax benefits |
40,472 | |||
|
Increase in current year unrecognized tax benefits |
33,684 | |||
|
|
|
|||
|
Unrecognized tax benefits as of 12/31/13 |
748,036 | |||
|
Increase in prior year unrecognized tax benefits |
295,038 | |||
|
Increase in current year unrecognized tax benefits |
49,834 | |||
|
|
|
|||
|
Unrecognized tax benefits as of 12/31/14 |
$ | 1,092,908 | ||
|
|
|
|||
The Company does not expect its unrecognized tax benefits to change significantly over the next twelve months. As of December 31, 2014, due to a valuation allowance against the Company’s deferred tax assets, none of the unrecognized tax benefits, if recognized, would affect the Company’s effective tax rate.
There are currently no federal or state audits in progress, tax years still subject to examination for Federal and the State authorities include all prior years due to the existence of net operating loss carry-forwards.
It is the Company’s practice to recognize interest and penalties related to income tax matters in income tax expense. As of December 31, 2014 the Company has no accrued interest and penalties related to uncertain tax positions.
68
OXiGENE, INC.
Notes to Financial Statements — (Continued)
9. Commitments and Contingencies
Facility Lease
The Company has a lease for its current facility which was amended in April 2014 to extend the term to June 30, 2019. The lease is for a total of 5,275 square feet of office space located in South San Francisco, California. Rent expense for the years ended December 31, 2014, 2013 and 2012 was $206,168, $212,473 and $516,257 respectively. The future minimum lease payments under the lease, as amended, are as follows:
| Amount | ||||
|
(In thousands) |
||||
|
2015 |
202 | |||
|
2016 |
209 | |||
|
2017 |
215 | |||
|
2018 |
221 | |||
|
Thereafter |
112 | |||
|
|
|
|||
|
Total lease obligations |
$ | 959 | ||
|
|
|
|||
Clinical Research Organization and Manufacturing Commitments
As of December 31, 2014, the Company has a balance of unapplied purchase orders for expenditures related to clinical research activities and outsourced drug manufacturing of approximately $4,803,000, of which approximately $92,000 was estimated and accrued at December 31, 2014 for services performed, leaving approximately $4,711,000 to be incurred. Of the $4,711,000 to be incurred, the Company expects to incur approximately $2,353,000 over the next twelve months.
The following table presents information regarding our contractual obligations as of December 31, 2014 in thousands:
| 2015 | 2016 | 2017 | 2018 | Thereafter | Total | |||||||||||||||||||
|
Clinical development and related commitments |
$ | 2,353 | $ | 1,480 | $ | 138 | $ | 37 | $ | 24 | $ | 4,032 | ||||||||||||
|
Operating leases |
202 | 209 | 215 | 221 | 112 | 959 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
|
Total contractual obligations |
$ | 2,555 | $ | 1,689 | $ | 353 | $ | 258 | $ | 136 | $ | 4,991 | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Clinical development and related commitments include certain contractual obligations under contracts related to clinical activities.
10. 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, 2014, 2013 or 2012.
11. Subsequent Event – Registered Offering of Common Stock and Warrants
On March 25, 2015, the Company closed a financing with institutional investors in which it raised approximately $10,000,000 in gross proceeds or approximately $9,350,000 in net proceeds, after deducting placement agents’ fees and before deducting other offering expenses. Investors purchased shares of the Company’s common stock, at a price per share of $1.7125. For each share of common stock purchased, investors received one warrant to purchase one half of a share of the Company’s common stock. A total of 5,839,420
69
OXiGENE, INC.
Notes to Financial Statements — (Continued)
shares of common stock were issued and warrants for the purchase of 2,919,710 shares of common stock were issued. The warrants are exercisable immediately, expire 5 years from the date of issuance, and have an exercise price of $1.7125 per share. Also, in connection with the offering, the Company issued to its placement agent and related persons warrants to purchase 233,577 shares of the Company’s common stock. The warrants issued to the placement agent and related persons are exercisable immediately after issuance, have an exercise price of $2.13 per share and terminate on June 14, 2017.
The warrants contain limitations that prevent each holder of warrants from acquiring shares upon exercise of the warrants that would cause the number of shares beneficially owned by it and its affiliates to exceed 4.99% of the total number of shares of the Company’s common stock then issued and outstanding, provided that, upon prior notice to the Company, a holder may increase or decrease this limitation provided any increase does not exceed 9.99% of the total number of shares of the Company’s common stock then issued and outstanding. In addition, upon certain changes in control of the Company, each holder of a warrant can elect to receive, subject to certain limitations and assumptions, securities in a successor entity. None of the warrants issued on March 25, 2015 have been exercised.
70
Exhibit 14.1
Revised [December 21, 2014]
OXiGENE, INC.
CORPORATE CODE OF CONDUCT AND ETHICS
FOREWORD
This Corporate Code of Conduct and Ethics, referred to as the “Code,” is intended to provide the company’s associates, as defined below, with a clear understanding of the principles of business conduct and ethics that are expected of them. The standards set forth in the Code apply to all associates. Every associate of the company must acknowledge his or her review of, and agreement to comply with, the Code as a condition of his or her relationship with the company. The term “associate” means every full and part-time employee of the company and its subsidiaries, every contractor with whom the company has a significant, ongoing business relationship (as determined in the judgment of the company’s senior management), all members of the company’s senior management, including the company’s Chief Executive Officer and Chief Financial Officer, and every member of the company’s Board of Directors, even if such member is not employed by the company.
Many of the standards outlined on the following pages will be familiar, for they reflect the fundamental values of fairness and integrity that are a part of daily life. Applying these standards to the company’s business should be an extension of the values by which associates are known as individuals and by which the company wants to be known.
It is the responsibility of each company associate to conduct himself or herself in an ethical business manner and also to do the utmost to ensure that others do the same. If any associate violates these standards, he or she can expect a disciplinary response, up to and including termination of any employment or other relationship with the company, and possibly other legal action. If any breach or violation of the Code is known to an associate, he or she is obligated to report the breach or violation to the Compliance Committee or the Hotline, as described in more detail below. By doing so, associates can help to ensure that the good faith efforts of all associates to comply with the Code are not undermined.
The ultimate responsibility for maintaining the Code rests with each associate. As individuals of personal integrity, associates can do no less than to behave in a way that will continue to bring credit to the company.
While it is impossible for this Code to describe every situation that may arise, the standards explained in this Code are guidelines that should govern associates’ conduct at all times. If associates are confronted with situations not covered by this Code, or have questions regarding the matters that are addressed in the Code, they are urged to consult with the Compliance Committee or the Hotline.
The provisions of the Code regarding the actions the company will take are guidelines which the company intends to follow. There may be circumstances, however, that in the company’s judgment require different measures or actions and in such cases it may act accordingly while still attempting to fulfill the principles underlying this Code.
Revised [December 21, 2014]
Table of Contents
| Page | ||||||
|
I. |
ADMINISTRATION OF THE CODE |
1 | ||||
|
II. |
GENERAL REQUIREMENTS |
3 | ||||
|
III. |
CONFLICTS OF INTEREST |
3 | ||||
|
IV. |
PROTECTION AND PROPER USE OF COMPANY ASSETS |
4 | ||||
|
V. |
FAIR DEALING WITH THIRD PARTIES AND ASSOCIATES |
7 | ||||
|
VI. |
GOVERNMENT RELATIONS |
8 | ||||
|
VII. |
COMPLIANCE WITH LAWS, RULES AND REGULATIONS |
9 | ||||
|
VIII. |
REPORTING VIOLATIONS UNDER THE CODE: NON-RETALIATION POLICY |
10 | ||||
|
IX. |
QUESTIONS UNDER THE CODE AND WAIVER PROCEDURES |
11 | ||||
|
X. |
FREQUENTLY ASKED QUESTIONS AND ANSWERS |
11 | ||||
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| I. | ADMINISTRATION OF THE CODE |
The company has attempted to design procedures that ensure maximum confidentiality and, most importantly, freedom from the fear of retaliation for complying with and reporting violations under the Code.
Q: Who is responsible for administering, updating and enforcing the Code?
A: The company’s Board of Directors has appointed a Compliance Committee to administer, update and enforce the Code. Ultimately, the Board of Directors of the company must ensure that the Compliance Committee fulfills its responsibilities.
The Compliance Committee is comprised of the company’s Chief Executive Officer, Chief Financial Officer, and the Office Manager. The primary responsibilities of the Compliance Committee are to:
| • | Oversee the administration of, and updates to, the Code based on legal requirements, regulations, best practices, and ethical considerations that are raised in the company’s operations; |
| • | Develop internal procedures to monitor and audit compliance with the Code; |
| • | Serve as point persons for reporting violations and asking questions under the Code; |
| • | Establish and oversee a mechanism for anonymous reporting of suspected violations of the Code by associates and refer, when appropriate, such reports to the Audit Committee; |
| • | Ensure that the Code is distributed to all associates and that all associates acknowledge the principles of the Code; |
| • | Oversee the implementation of a training program around the Code; |
| • | Monitor and respond to reports that are made to the Hotline; |
| • | Oversee the assessment of compliance success with the Code; |
| • | Ensure the conduct of internal investigations, with the assistance of counsel, of suspected compliance violations; |
| • | Evaluate disciplinary action for associates who violate the Code; |
| • | In the case of more severe violations of the Code, make recommendations regarding disciplinary action to the Board of Directors or a committee thereof; and |
| • | Evaluate the effectiveness of the Code and improve the Code. |
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The Compliance Committee will provide a summary of all matters considered under the Code to the Board of Directors or a committee thereof at each regular meeting thereof, or sooner if warranted by the severity of the matter. All proceedings and the identity of the person or persons reporting will be kept as confidential as practicable under the circumstances.
Q: How can I contact the Compliance Committee?
A: The names and phone numbers of each member of the Compliance Committee are listed below. Any one of these individuals can assist you in answering questions or reporting violations or suspected violations under the Code.
Dai Chaplin
Chief Executive Officer
Compliance Committee Member
Barbara Riching
Chief Financial Officer
Compliance Committee Member
Meaquel Hodges
Office Manager
Compliance Committee Member
Q: Who administers the Hotline, and how can I contact the Hotline?
A: The Compliance Hotline, or the “Hotline”, is operated by a third party service provider, which the company has retained to receive reports of violations or suspected violations under the Code. Reports made to the Hotline will, in turn, be provided directly to the Compliance Committee and to the Chairman of the Board of Directors. If requested by the person making the report, the identity of the person or persons reporting matters to the Hotline will be kept confidential. The Hotline may be reached 24 hours a day, 7 days a week at the following toll-free number and internet address:
Contact Information for the Compliance Hotline:
| Toll-Free Telephone Number | 844-990-0002 | |
| Hotline E-mail Address | reports@lighthouse-services.com (must include company name with report) | |
| Hotline Internet Address | www.lighthouse-services.com/oxigene |
Any associate may make reports of concerns relating to accounting and auditing matters, suspected violations under the Code, or other issues, to either the Compliance Committee or the Hotline on an anonymous basis. You are encouraged, but not required, to provide your name so that the Compliance Committee and/or the Hotline can contact you with questions or for further details.
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Revised [December 21, 2014]
| II. | GENERAL REQUIREMENTS |
To be honest, fair, and accountable in all business dealings and obligations, and to ensure:
| • | the ethical handling of conflicts of interest between personal and professional relationships; |
| • | full, fair, accurate, timely and understandable disclosure in the reports required to be filed by the company with the Securities and Exchange Commission and in other public communications made by the company; and |
| • | compliance with applicable governmental laws, rules and regulations. |
| III. | CONFLICTS OF INTEREST |
Associates should avoid any situation that may involve, or even appear to involve, a conflict between their personal interests and the interests of the company. In dealings with third parties with whom the company has a current or potential business relationship, each associate should act in the best interests of the company to the exclusion of personal advantage. For purposes of this section, a “significant” amount or interest shall be deemed to be any amount in excess of $1,000. Associates are prohibited from any of the following activities which could represent an actual or perceived conflict of interest:
| • | No associate or immediate family member of an associate shall have a significant financial interest in, or obligation to, any outside enterprise which does or seeks to do business with the company or which is an actual or potential competitor of the company, without prior approval of the Compliance Committee, or in the case of executive officers or members of the Board of Directors, the full Board of Directors or a committee thereof. |
| • | No associate shall conduct a significant amount of business on the company’s behalf with an outside enterprise which does or seeks to do business with the company if an immediate family member of the associate is a principal, officer or employee of such enterprise, without prior approval of the Compliance Committee, or in the case of executive officers or members of the Board of Directors, the full Board of Directors or a committee thereof. |
| • | No associate shall use any company property or information or his or her position at the company for his or her personal gain. |
| • | No associate shall engage in activities that are directly competitive with those in which the company is engaged. |
| • |
No associate shall divert a business opportunity from the company to such individual’s own benefit. If an associate becomes aware of an opportunity to acquire or profit from a business opportunity or investment in which the company is or may become involved or in which the company may have an existing interest, the associate should disclose the relevant facts to the Compliance Committee (or, in the event of a request by a member of the Compliance |
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Revised [December 21, 2014]
|
Committee, to the Chairman of the Board). The associate may proceed to take advantage of such opportunity only if the company is unwilling or unable to take advantage of such opportunity as notified in writing by the Compliance Committee. |
| • | No associate or immediate family member of an associate shall receive any loan or monetary advance from the company, or be the beneficiary of a guarantee by the company of a loan or monetary advance from a third party, except for customary advances or corporate credit in the ordinary course of business or approved by the Compliance Committee. Please see Section IV.E. below, “Corporate Advances”, for more information on permitted corporate advances. |
In addition, the Audit Committee of the Board of Directors will review and approve all related-person transactions, as required by the Securities and Exchange Commission, The Nasdaq Stock Market or any other regulatory body to which the company is subject.
Each associate should make prompt and full disclosure in writing to the Compliance Committee of any situation that may involve a conflict of interest. Failure to disclose any actual or perceived conflict of interest is a violation of the Code.
| IV. | PROTECTION AND PROPER USE OF COMPANY ASSETS |
Proper protection and use of company assets and assets entrusted to it by others, including proprietary information, is a fundamental responsibility of each associate of the company. Associates must comply with security programs to safeguard such assets against unauthorized use or removal, as well as against loss by criminal act or breach of trust. The provisions hereof relating to protection of the company’s property also apply to property of others entrusted to it (including proprietary and confidential information).
| A. | Proper Use of Company Property |
The removal from the company’s facilities of the company’s property is prohibited, unless authorized by the company. This applies to furnishings, equipment, and supplies, as well as property created or obtained by the company for its exclusive use – such as files, personnel information, reference materials and reports, computer software, data processing programs and data bases. Neither originals nor copies of these materials may be removed from the company’s premises or used for purposes other than the company’s business without prior written authorization from the Compliance Committee.
Each associate has an obligation to use the time for which he or she receives compensation from the company productively. Work hours should be devoted to activities directly related to the company’s business.
| B. | Confidential Information |
The company provides its associates with confidential information relating to the company and its business with the understanding that such information is to be held in confidence and not communicated to anyone who is not authorized to see it, except as may be
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Revised [December 21, 2014]
required by law. The types of information that each associate must safeguard include (but are not limited to) the company’s plans and business strategy, unannounced contracts, significant projects, patents, patent applications, trade secrets, and sensitive financial information, whether in electronic or paper format. These are costly, valuable resources developed for the exclusive benefit of the company. No associate shall disclose the company’s confidential information to an unauthorized third party or use the company’s confidential information for his or her own personal benefit.
Each associate should also refer to the provisions of any Confidentiality Agreement entered into with the company.
| C. | Accurate Records and Reporting |
Under law, the company is required to keep books, records and accounts that accurately and fairly reflect all transactions, dispositions of assets and other events that are the subject of specific regulatory record keeping requirements, including generally accepted accounting principles and other applicable rules, regulations and criteria for preparing financial statements and for preparing periodic reports filed with the Securities and Exchange Commission. All company reports, accounting records, expense accounts, invoices, purchase orders, and other documents must accurately and clearly represent the relevant facts and the true nature of transactions. Reports and other documents should state all material facts of a transaction and not omit any information that would be relevant in interpreting such report or document. Under no circumstance may there be any unrecorded liability or fund of the company, regardless of the purposes for which the liability or fund may have been intended, or any improper or inaccurate entry knowingly made on the books or records of the company. No payment on behalf of the company may be approved or made with the intention, understanding or awareness that any part of the payment is to be used for any purpose other than that described by the documentation supporting the payment. In addition, intentional accounting misclassifications (e.g., expense versus capital) and improper acceleration or deferral of expenses or revenues are unacceptable reporting practices that are expressly prohibited.
The company has developed and maintains a system of internal controls to provide reasonable assurance that transactions are executed in accordance with management’s authorization, are properly recorded and posted, and are in compliance with regulatory requirements. The system of internal controls within the company includes written policies and procedures, budgetary controls, supervisory review and monitoring, and various other checks and balances, and safeguards.
The company has also developed and maintains a set of disclosure controls and procedures to ensure that all of the information required to be disclosed by the company in the reports that it files or submits under the Securities Exchange Act is recorded, processed, summarized and reported within the time periods specified by the Securities and Exchange Commission’s rules and forms.
Associates are expected to be familiar with, and to adhere strictly to, these internal controls and disclosure controls and procedures.
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Revised [December 21, 2014]
Responsibility for compliance with these internal controls and disclosure controls and procedures rests not solely with the company’s accounting personnel, but with all associates involved in approving transactions, supplying documentation for transactions, and recording, processing, summarizing and reporting of transactions and other information required by periodic reports filed with the Securities and Exchange Commission. Because the integrity of the company’s external reports to shareholders and the Securities and Exchange Commission depends on the integrity of the company’s internal reports and record-keeping, all associates must adhere to the highest standards of care with respect to the company’s internal records and reporting. The company is committed to full, fair, accurate, timely, and understandable disclosure in the periodic reports required to be filed by it with the Securities and Exchange Commission, and it expects each associate to work diligently towards that goal.
Any associate who believes the company’s books and records are not in accord with these requirements should immediately report the matter to the Compliance Committee or the Hotline. The company has adopted explicit non-retaliation policies with respect to these matters, as described in Section VIII below.
| D. | Document Retention |
Numerous federal and state statutes require the proper retention of many categories of records and documents that are commonly maintained by companies. In consideration of those legal requirements and the company’s business needs, all associates must maintain records in accordance with the company’s document retention policy.
In addition, any record, in paper or electronic format, relevant to a threatened, anticipated or actual internal or external inquiry, investigation, matter or lawsuit may not be discarded, concealed, falsified, altered, or otherwise made unavailable, once an associate has become aware of the existence of such threatened, anticipated or actual internal or external inquiry, investigation, matter or lawsuit. Associates must handle such records in accordance with the procedures outlined in the company’s document retention policy.
When in doubt regarding retention of any record, an associate must not discard or alter the record in question and should seek guidance from the Compliance Committee. Associates should also direct all questions regarding the company’s document retention policy and related procedures to a member of the Compliance Committee.
| E. | Corporate Advances |
Under law, the company may not loan money to associates except in limited circumstances. It shall be a violation of the Code for any associate to advance company funds to any other associate or to himself or herself except for usual and customary business advances for legitimate corporate purposes which are approved by a supervisor or pursuant to a corporate credit card for usual and customary, legitimate business purposes. It is the company’s policy that any advance to an associate over $1,000 be approved in advance by the Compliance Committee.
Company credit cards are to be used only for authorized, legitimate business purposes. An associate will be responsible for any unauthorized charges to a company credit card.
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Revised [December 21, 2014]
| V. | FAIR DEALING WITH THIRD PARTIES AND ASSOCIATES |
The company does not seek to gain any advantage through the improper use of favors or other inducements. Good judgment and moderation must be exercised to avoid misinterpretation and adverse effect on the reputation of the company or its associates. Offering, giving, soliciting or receiving any form of bribe to or from an employee of a third party to influence that employee’s conduct is strictly prohibited.
| A. | Giving Gifts |
Cash or cash-equivalent gifts must not be given by an associate to any person or enterprise. Gifts, favors and entertainment may be given to non-governmental employees if what is given:
| • | is consistent with customary business practice; |
| • | is not excessive in value and cannot be construed as a bribe or pay-off; |
| • | is not in violation of applicable law or ethical standards; and |
| • | will not embarrass the company or the associate if publicly disclosed. |
See also subsection D below for considerations relating to gifts to foreign officials and Section VI. A below for considerations relating to gifts to government employees.
| B. | Receiving Gifts |
Gifts, favors, entertainment or other inducements may not be accepted by associates or members of their immediate families from any person or organization that does or seeks to do business with, or is a competitor of, the company, except as common courtesies usually associated with customary business practices. If the gift is of more than token value, the Compliance Committee must approve its acceptance.
An especially strict standard applies when suppliers are involved. If a gift unduly influences or makes an associate feel obligated to “pay back” the other party with business, receipt of the gift is unacceptable.
It is never acceptable to accept a gift in cash or cash equivalent. Even gifts of token value must be declined and returned to the sender.
| C. | Unfair Competition |
Although the free enterprise system is based upon competition, rules have been imposed stating what can and what cannot be done in a competitive environment. The following practices can lead to liability for “unfair competition” and should be avoided. They are violations of the Code.
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Revised [December 21, 2014]
Disparagement of Competitors. It is not illegal to point out weaknesses in a competitor’s service, product or operation; however, associates may not spread false rumors about competitors or make misrepresentations about their businesses. For example, an associate may not pass on anecdotal or unverified stories about a competitor’s products or services as the absolute truth (e.g., the statement that “our competitors’ diagnostic testing procedures have poor quality control”).
Disrupting a Competitor’s Business. This includes bribing a competitor’s employees, posing as prospective customers or using deceptive practices such as enticing away employees in order to obtain secrets or destroy a competitor’s organization. For example, it is not a valid form of “market research” to visit a competitor’s place of business posing as a customer.
| D. | Unfair Practices in International Business |
Under the Foreign Corrupt Practices Act (“FCPA”), associates of the company are prohibited from making certain gifts to foreign officials. “Foreign officials” include not only persons acting in an official capacity on behalf of a foreign government, agency, department or instrumentality, but also representatives of international organizations, foreign political parties and candidates for foreign public office. The gift is “corrupt” under the FCPA if it is made for the purpose of:
| • | Influencing any act or decision of a foreign official in his official capacity; |
| • | Inducing a foreign official to do or omit to do any act in violation of his lawful duty; |
| • | Inducing a foreign official to use his position to affect any decision of the government; or |
| • | Inducing a foreign official to secure any “improper advantage.” |
A gift is still “corrupt” even when paid through an intermediary. Any associate who has any questions whatsoever as to whether a particular gift might be “corrupt” under the FCPA, please contact the Compliance Committee.
| VI. | GOVERNMENT RELATIONS |
Associates must adhere to the highest standards of ethical conduct in all relationships with government employees and must not improperly attempt to influence the actions of any public official.
| A. | Payments to Officials |
Payments or gifts shall not be made directly or indirectly to any government official or associate if the gift or payment is illegal under the laws of the country having jurisdiction over the transaction, or if it is for the purpose of influencing or inducing the recipient to do, or omit to do, any act in violation of his or her lawful duty. Under no circumstances should gifts be given to employees of the United States Government.
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Revised [December 21, 2014]
| B. | Political Contributions |
Company funds, property or services may not be contributed to any political party or committee, or to any candidate for or holder of any office of any government. This policy does not preclude, where lawful, company expenditures to support or oppose public referendum or separate ballot issues, or, where lawful and when reviewed and approved in advance by the Compliance Committee, the formation and operation of a political action committee.
| VII. | COMPLIANCE WITH LAWS, RULES AND REGULATIONS |
| A. | Insider Trading Policy |
The company expressly forbids any associate from trading on material non-public information or communicating material non-public information to others in violation of the law. This conduct is frequently referred to as “insider trading.” This policy applies to every associate of the company and extends to activities both within and outside their duties to the company, including trading for a personal account.
The concept of who is an “insider” is broad. It includes officers, directors and employees of a company. In addition, a person can be a “temporary insider” if he or she enters into a special confidential relationship in the conduct of a company’s affairs and as a result is given access to information solely for the company’s purpose. A temporary insider can include, among others, a company’s investment advisors, agents, attorneys, accountants and lending institutions, as well as the employees of such organizations. An associate may also become a temporary insider of another company with which the company has a contractual relationship, to which it provides advice or for which it performs other services.
Trading on inside information is not a basis for liability unless the information is material. This is information that a reasonable investor would consider important in making his or her investment decisions, or information that is likely to have a significant effect on the price of a company’s securities.
Information is non-public until it has been effectively communicated to the marketplace. Tangible evidence of such dissemination is the best indication that the information is public. For example, information found in a report filed with the Securities and Exchange Commission or appearing in a national newspaper would be considered public.
Each associate should be familiar with and abide by the company’s Insider Trading Policy. A copy of this policy is given to all new associates of the company and is available from any member of the Compliance Committee.
| B. | Equal Employment Opportunity |
The company makes employment-related decisions without regard to a person’s race, color, religious creed, age, sex, sexual orientation, marital status, national origin, ancestry, present or past history of mental disorder, mental retardation, learning disability or physical disability, including, but not limited to, blindness and genetic predisposition, or any other factor unrelated to a person’s ability to perform the person’s job. “Employment decisions” generally mean decisions relating to hiring, recruiting, training, promotions and compensation, but the term may encompass other employment actions as well.
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Revised [December 21, 2014]
The company encourages its associates to bring any problem, complaint or concern regarding any alleged employment discrimination to the attention of the Compliance Committee or the Hotline.
| C. | Sexual Harassment Policy |
The company is committed to maintaining a collegial work environment in which all individuals are treated with respect and dignity and which is free of sexual harassment. In keeping with this commitment, the company will not tolerate sexual harassment of associates by anyone, including any supervisor, co-worker, vendor, client or customer, whether in the workplace, at assignments outside the workplace, at company-sponsored social functions or elsewhere.
Each associate should be familiar with and abide by the company’s Sexual Harassment Policy. A copy of this policy is given to all associates of the company and is available from any member of the Compliance Committee.
| D. | Health, Safety & Environment Laws |
Health, safety, and environmental responsibilities are fundamental to the company’s values. Associates are responsible for ensuring that the company complies with all provisions of the health, safety, and environmental laws of the United States and of other countries where the company does business.
The penalties that can be imposed against the company and its associates for failure to comply with health, safety, and environmental laws can be substantial, and include imprisonment and fines.
| VIII. | REPORTING VIOLATIONS UNDER THE CODE: NON-RETALIATION POLICY |
Any associate of the company having any information or knowledge regarding the existence of any violation or suspected violation of the Code has a duty to report the violation or suspected violation to the Compliance Committee or the Hotline. Failure to report suspected or actual violations is itself a violation of the Code and may subject the associate to disciplinary action, up to and including termination of employment or legal action. The company will endeavor to keep reports confidential to the fullest extent practicable under the circumstances.
Any associate who reports a suspected violation under the Code by the company, or its agents acting on behalf of the company, to the Compliance Committee or the Hotline, may not be fired, demoted, reprimanded or otherwise harmed for, or because of, the reporting of the suspected violation, regardless of whether the suspected violation involves the associate, the associate’s supervisor or senior management of the company.
In addition, any associate who reports a suspected violation under the Code which the associate reasonably believes constitutes a violation of a federal statute by the company, or its
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Revised [December 21, 2014]
agents acting on behalf of the company, to a federal regulatory or law enforcement agency, may not be reprimanded, discharged, demoted, suspended, threatened, harassed or in any manner discriminated against in the terms and conditions of the associate’s employment for, or because of, the reporting of the suspected violation, regardless of whether the suspected violation involves the associate, the associate’s supervisor or senior management of the company.
| IX. | QUESTIONS UNDER THE CODE AND WAIVER PROCEDURES |
Associates are encouraged to consult with the Compliance Committee about any uncertainty or questions they may have under the Code.
If any situation should arise where a course of action would likely result in a violation of the Code but for which the associate thinks that a valid reason for the course of action exists, the associate should contact the Compliance Committee to obtain a waiver prior to the time the action is taken. Absent exceptional circumstances, no waivers will be granted after the fact for actions already taken. Except as noted below, the Compliance Committee will review all the facts surrounding the proposed course of action and will determine whether a waiver from any policy in the Code should be granted.
Waiver Procedures for Executive Officers and Directors. Waiver requests by an executive officer or member of the Board of Directors shall be referred by the Compliance Committee, with its recommendation, to the Board of Directors or a committee thereof for consideration. If either (i) a majority of the independent directors on the Board of Directors, or (ii) a committee comprised solely of independent directors agrees that the waiver should be granted, it will be granted. The company will disclose the nature and reasons for the waiver on a Form 8-K to be filed promptly with the Securities and Exchange Commission or otherwise as required by the Securities and Exchange Commission or The Nasdaq Stock Market. If the Board denies the request for a waiver, the waiver will not be granted and the associate may not pursue the intended course of action.
It is the company’s policy only to grant waivers from the Code in limited and compelling circumstances.
| X. | FREQUENTLY ASKED QUESTIONS AND ANSWERS |
The following questions and answers address each associate’s obligation to comply with the Code. The company has attempted to design procedures that ensure maximum confidentiality and, most importantly, freedom from the fear of retaliation for complying with and reporting violations under the Code.
Q: Do I have a duty to report violations under the Code?
A: Yes, participation in the Code and its compliance program is mandatory. You must immediately report any suspected or actual violation of the Code to the Compliance Committee or the Hotline. The company will endeavor to keep reports confidential to the fullest extent practicable under the circumstances. Failure to report suspected or actual violations is itself a violation of the Code and may subject you to disciplinary action, up to and including termination of employment or legal action.
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Revised [December 21, 2014]
Q: I’m afraid of being fired for raising questions or reporting violations under the Code. Will I be risking my job if I do?
A: The Code contains a clear non-retaliation policy which is located in Section VIII of the Code, meaning that if you in good faith report a violation of the Code by the company, or its agents acting on behalf of the company, to the Compliance Committee or the Hotline, the company will undertake to protect you from being fired, demoted, reprimanded or otherwise harmed for reporting the violation, even if the violation involves you, your supervisor, or senior management of the company. The company will endeavor to keep confidential any report you make to the Compliance Committee to the extent practicable under the circumstances.
In addition, if you report a suspected violation under the Code which you reasonably believe constitutes a violation of a federal statute by the company, or its agents acting on behalf of the company, to a federal regulatory or law enforcement agency, you may not be reprimanded, discharged, demoted, suspended, threatened, harassed or in any manner discriminated against in the terms and conditions of your employment for reporting the suspected violation, regardless of whether the suspected violation involves you, your supervisor or senior management of the company.
Q: How are suspected violations investigated under the Code?
A: When a suspected violation is reported to the Compliance Committee or the Hotline, the Compliance Committee and/or the Hotline will gather information about the allegation by interviewing the associate reporting the suspected violation, the associate who is accused of the violation and/or any co-workers or associates of the accused associates to determine if a factual basis for the allegation exists. If the allegation involves a member of the Compliance Committee, that member will be replaced on the Compliance Committee for this purpose by an independent member of the Board of Directors. The reporting associate’s immediate supervisor will not be involved in the investigation if the reported violation involved that supervisor. The company will endeavor to keep the identity of the reporting associate confidential to the fullest extent practicable under the circumstances.
If the report is not substantiated, the reporting associate will be informed and at that time will be asked for any additional information not previously communicated. If there is no additional information, the Compliance Committee will close the matter as unsubstantiated.
If the allegation is substantiated, the Compliance Committee will make a judgment as to the degree of severity of the violation and the appropriate disciplinary response. In more severe cases, the Compliance Committee will make a recommendation to the Board of Directors of the company for its approval. The Board’s decision as to disciplinary and corrective action will be final. In the case of less severe violations, the Compliance Committee may consider other appropriate disciplinary action.
The Compliance Committee shall provide a summary of all matters considered under the Code to the Board of Directors or a committee thereof at each regular meeting thereof, or sooner if warranted by the severity of the matter.
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Revised [December 21, 2014]
The company will endeavor to keep all proceedings and the identity of the reporting person as confidential as practicable under the circumstances.
Q: Do I have to participate in any investigation under the Code?
A: Your full cooperation with any pending investigation under the Code is a condition of your continued relationship with the company. The refusal to cooperate fully with any investigation is a violation of the Code and grounds for discipline, up to and including termination.
Q: What are the consequences of violating the Code?
A: As explained above, associates who violate the Code may be subject to discipline, up to and including termination of employment. Associates who violate the Code may simultaneously violate federal, state, local or foreign laws, regulations or policies. Such associates may be subject to prosecution, imprisonment and fines, and may be required to make reimbursement to the company, the government or any other person for losses resulting from the violation. They may be subject to punitive or treble damages depending on the severity of the violation and applicable law.
Q: What if I have questions under the Code or want to obtain a waiver under any provision of the Code?
A: The Compliance Committee can help answer questions you may have under the Code. In addition, Section IX of the Code provides information on how you may obtain a waiver from the Code; waivers will be granted only in very limited circumstances. You should never pursue a course of action that is unclear under the Code without first consulting the Compliance Committee, and if necessary, obtaining a waiver from the Code.
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Revised [December 21, 2014]
APPENDIX
ASSOCIATE’S AGREEMENT TO COMPLY
I have read the OXiGENE, Inc. Corporate Code of Conduct and Ethics (the “Code”). I have obtained an interpretation of any provision about which I had a question. I agree to abide by the provisions of the Code. Based on my review, I acknowledge that
| To the best of my knowledge, I am not in violation of, or aware of any violation by others of, any provision contained in the Code; | ||
| OR | ||
| I have made a full disclosure on the reverse side of this acknowledgement of the facts regarding any possible violation of the provisions set forth in the Code. | ||
In addition, I understand that I am required to report any suspected or actual violation of the Code. I understand that I am required to cooperate fully with the company in connection with the investigation of any suspected violation. I understand that my failure to comply with the Code or its procedures may result in disciplinary action, up to and including termination.
| By: |
|
Date: |
|
|||||
| Name: |
|
|||||||
| (Please print) | ||||||||
14
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We consent to the incorporation by reference in the following Registration Statements of OXiGENE, Inc.:
| 1. | Registration Statement (Form S-1 No. 333-190464) of OXiGENE, Inc., |
| 2. | Registration Statements (Form S-3 Nos. 333-196589, 333-191531, 333-188114, 333-181813, 333-155372, 333-128528, 333-106307, 333-109433, 333-160976 and 333-165826) of OXiGENE, Inc., |
| 3. | Registration Statement (Form S-8 No. 333-05787) pertaining to the Amended and Restated Stock Incentive Plan of OXiGENE, Inc., |
| 4. | Registration Statements (Form S-8 Nos. 333-92747, 333-32958 and 333-117083) pertaining to the 1996 Stock Incentive Plan of OXiGENE, Inc., |
| 5. | Registration Statement (Form S-8 No. 333-84870) pertaining to the Compensation Award Stock Agreements between Registrant and Certain Directors of OXiGENE, Inc., |
| 6. | Registration Statement (Form S-8 No. 333-85860) pertaining to the Compensation Award Stock Agreement between Registrant and a Company Director of OXiGENE, Inc., |
| 7. | Registration Statement (Form S-8 No. 333-84872) pertaining to the Restricted Stock Agreements between Registrant and Certain Employees and Non-Employees of OXiGENE, Inc., |
| 8. | Registration Statement (Form S-8 Nos. 333-126636, 333-181810 and 333-190409) pertaining to the OXiGENE, Inc. 2005 Stock Plan, as amended. |
| 9. | Registration Statement (Form S-8 No. 333-159585) pertaining to the OXiGENE, Inc. 2005 Stock Plan and the OXiGENE, Inc. 2009 Employee Stock Purchase Plan of OXiGENE, Inc., |
| 10. | Registration Statement (Form S-8 No. 333-177628) pertaining to the OXiGENE, Inc. 2005 Stock Plan and the OXiGENE, Inc. 2009 Employee Stock Purchase Plan, |
and in the related Prospectuses of our report dated March 30, 2015, with respect to the financial statements of OXiGENE, Inc., included in this Annual Report (Form 10-K) for the year ended December 31, 2014.
/s/ Ernst & Young LLP
San Jose, California
March 30, 2015
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT
TO RULE 13A-14(A) AND 15D-14(A)
I, David J. Chaplin, certify that:
1. I have reviewed this annual report on Form 10-K of OXiGENE, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| Date: March 30, 2015 | By: | /s/ David J. Chaplin | ||||
| David J. Chaplin | ||||||
| Chief Executive Officer |
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT
TO RULE 13A-14(A) AND 15D-14(A)
I, Barbara Riching, certify that:
1. I have reviewed this annual report on Form 10-K of OXiGENE, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| Date: March 30, 2015 | By: | /s/ Barbara Riching | ||||
| Barbara Riching | ||||||
| Chief Financial Officer |
Exhibit 32.1
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of OXiGENE, Inc., a Delaware corporation (the “Company”), does hereby certify, to such officer’s knowledge, that:
The Annual Report for the year ended December 31, 2014 (the “Form 10-K”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-K fairly presents, in all material respects, the financial condition and results of operations of the Company.
| Date: March 30, 2015 | /s/ David J. Chaplin | |||||
| David J. Chaplin, Chief Executive Officer | ||||||
| Date: March 30, 2015 | /s/ Barbara Riching | |||||
| Barbara Riching, Chief Financial Officer | ||||||