þ
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
|
For the fiscal year ended December 31, 2005 | ||
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
|
For the transition period from to |
Delaware
|
13-3679168 | |
(State or other jurisdiction of
incorporation or organization) |
(I.R.S. Employer
Identification No.) |
|
230 Third Avenue
Waltham, MA (Address of principal executive offices) |
02451
(Zip Code) |
1
ITEM 1. | BUSINESS |
Development Programs and Product Candidates |
Vascular Disrupting Agents, or VDAs |
2
CA4P and Its Application in Oncology |
| A Phase III clinical trial in patients with advanced, inoperable Stage IIIb/ IV non small cell lung cancer, or NSCLC, in combination with chemotherapy and radiotherapy. This trial has received regulatory clearance from the Medicines and Healthcare Products Regulatory Agency, or MHRA, in the United Kingdom, but has not yet initiated patient enrollment; | |
| A randomized Phase II clinical trial in patients with unresectable Stage IIIa/ IIIb NSCLC in combination with concurrent chemoradiotherapya widely accepted standard of treatment for NSCLC in the United States. The trial will be conducted under OXiGENEs Investigational New Drug, or IND, application on file with the United States Food and Drug Administration, or FDA; | |
| A Phase II clinical trial in patients with advanced, inoperable, platinum-resistant ovarian cancer in combination with carboplatin and paclitaxel; | |
| A Phase Ib clinical trial in patients with advanced solid tumors in combination with the anti-angiogenic drug, Avastin ® (Bevacizumab), which has not yet initiated patient enrollment; | |
| A Phase I/ II clinical trial in patients with advanced NSCLC, head & neck or prostate cancers in combination with radiotherapy; | |
| A Phase I clinical trial in patients with advanced and recurring cervical cancer in combination with cisplatin; | |
| A Phase I/ II clinical trial in patients with advanced colorectal cancer in combination with the anti-CEA monoclonal antibody A5B7; | |
| A Phase II clinical trial in patients with anaplastic thyroid cancer as a monotherapy; and | |
| A Phase I/ II clinical trial in patients with newly diagnosed anaplastic thyroid cancer in combination with doxorubicin, cisplatin and radiotherapy. |
3
CA4P and Its Application in Ophthalmology |
Ortho-Quinone Prodrugs, or OQPs |
General |
4
5
(1) CA4P was manageable and well tolerated. | |
(2) A similar maximum tolerated dose was determined in each clinical trial. | |
(3) The side-effect profile did not display the typical toxicities associated with chemotherapeutic agents. | |
(4) CA4P demonstrated reductions in tumor blood flow below, up to, and beyond the maximum tolerated dose. | |
(5) There is data to support biological and vascular activity in humans with a meaningful therapeutic index. | |
(6) Promising signs of clinical effects were observed with one complete response, one partial response, two cases of measurable tumor size reduction and three cases of long-term stabilization of disease. |
6
CA4P in Oncology |
Phase III: CA4P in Combination with Chemotherapy and Radiotherapy for the Treatment of Non Small Cell Lung Cancer |
7
Phase II: CA4P in Combination with Concurrent Chemoradiotherapy for the Treatment of Stage IIIa/IIIb NSCLC |
Phase II: CA4P in Combination with Chemotherapy for the Treatment of Advanced, Platinum-Resistant Ovarian Cancer |
Phase Ib: CA4P in Combination with the Anti-Angiogenic Agent, Avastin, for the Treatment of Solid Malignancies |
8
Other clinical trials with CA4P in oncology |
9
CA4P in Diseases of the Eye |
Phase II: CA4P for the Treatment of Myopic Macular Degeneration |
10
Government Regulation And Product Approval |
| completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices; | |
| submission of an investigational new drug application, or IND, which must become effective before human clinical trials may begin; | |
| performance of adequate and well-controlled human clinical trials according to Good Clinical Practices to establish the safety and efficacy of the proposed drug for its intended use; | |
| submission to the FDA of an NDA; | |
| satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with current good manufacturing practice, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drugs identity, strength, quality and purity; and | |
| FDA review and approval of the NDA. |
United States Drug Development Process |
11
| Phase I: The drug is initially introduced into healthy human subjects or patients with the disease 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. | |
| Phase II: Involves studies in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. | |
| Phase III: 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. |
U.S. Review and Approval Processes |
12
Expedited review and approval |
Orphan Drug |
13
Pediatric Exclusivity |
Post-approval Requirements |
14
Foreign Regulation |
Reimbursement |
15
| Gray Cancer Institute, Middlesex, United Kingdom; | |
| Baylor University, Waco, Texas; | |
| Arizona State University, Tempe, Arizona; | |
| The University of Texas MD Anderson Cancer Center, Houston, Texas; and, | |
| Beth Israel Deaconess Medical Center, Boston, Massachusetts. |
16
17
Patents Pending | Patents Granted | |||||||
Product Line
|
||||||||
Combretastatins
|
14 | 10 | ||||||
Baylor VDA Compounds
|
9 | 7 | ||||||
Benzamides, Nicotinamides, & Cordycepins
|
1 | 7 | ||||||
Diagnostic
|
0 | 1 | ||||||
Total
|
24 | 25 |
Title of Patent | U.S. Patent No. | Date of Expiration | Holder of Patent | Importance | ||||||||
Combretastatin A-4
|
4,996,237 | February 26, 2008 | Arizona State University | Provides composition-of-matter protection for the active, tubulin-binding parent compound of the prodrug CA4P, as well as protection for methods-of-use for treatment of cancer. CA4 is generated in the body following administration of CA4P, which is the Companys most advanced product. | ||||||||
Combretastatin A-4 Prodrug
|
5,561,122 | December 22, 2014 | Arizona State University | Provides composition-of-matter protection for the Companys lead VDA compound, CA4P. Claims were also granted for methods of using CA4P for the treatment of cancer. | ||||||||
Isolation, Structural Elucidation, and Synthesis of novel
Antineoplastic Agents termed Combretastatins
|
5,569,786 | October 29, 2013 | Arizona State University | Provides composition-of-matter protection for several Combretastatins, including CA1, which is the active, tubulin-binding compound of OXi4503, the Companys most advanced second generation compound. | ||||||||
Isolation, Structural Elucidation, and Synthesis of novel
Antineoplastic Agents termed Combretastatins
|
5,409,953 |
April 25,
2012 |
Arizona State University | Provides methods of using Combretastins, including CA1, for the treatment of cancerous cells. CA1 is the active, tubulin-binding parent compound of OXi4503, the Companys most advanced second generation compound. |
18
Title of Patent
U.S. Patent No.
Date of Expiration
Holder of Patent
Importance
6,538,038
February 16, 2020
OXiGENE, Inc.
Provides methods of using phosphate prodrugs of tubulin- binding
compounds, including CA4P and OXi4503, to selectively target the
proliferating vasculature of cancers, proliferative
retinopathies, and other diseases characterized by the presence
of unwanted neovascularization.
6,670,344
September 11, 2021
Bristol-Myers Squibb Company
Provides novel Tromethamine (TRIS) and Histidine
salt forms of CA4P along with methods for their use and
manufacture. The preferred TRIS salt composition provides
enhanced formulation properties over the Disodium salt of CA4P.
6,743,937
July 17,
2021
OXiGENE, Inc.
Provides methods of synthesizing combretastatin A4 phosphate
esters, prodrugs and
trans
-isomers thereof.
6,773,702
December 26, 2021
OXiGENE, Inc. and Bristol-Myers Squibb Company
Provides treatment methods for counteracting tumor-induced
immunosuppression (e.g., during conventional immunotherapy) that
avoid vascular destruction by administering combretastatin A4 or
prodrugs thereof.
6,855,702
September 11, 2021
Bristol-Myers Squibb Company
Provides optionally substituted aliphatic organic amine forms of
CA4P, and pharmaceutical compositions comprising such compounds.
19
20
ADRIAN L. HARRIS, M.D. is Cancer Research UK Professor of Clinical Oncology at the University of Oxford, and Director of the Cancer Research UK Molecular Oncology Laboratories at the Universitys Weatherall Institute of Molecular Medicine. He is involved in clinical trials of anti-angiogenesis therapy, signal blockade inhibitors and immunotherapy. His clinical research interests include breast cancer, melanoma, and renal cancer. | |
ROBERT S. KERBEL, Ph.D. is known internationally for his research into cancer metastasis, drug resistance and tumor angiogenesis. He is a senior scientist, as well as the Canada Research Chair in Molecular Medicine at Sunnybrook and Womens College Health Sciences Centre in Toronto and Professor of the Department of Medical Biophysics at the University of Toronto. He is the author of more than 270 scientific papers and the recipient of numerous scientific awards. Dr. Kerbel serves on the editorial boards of many scientific journals, including Cancer Research, Clinical Cancer Research, Molecular Cancer Research and Angiogenesis . He was Editor-in -Chief of Cancer & Metastasis Reviews from 1991-2001. Dr. Kerbel received his B.S. from the University of Toronto and his Ph.D. in immunology from Queens University. He was a post-doctoral fellow in cancer biology at the Chester Beatty Research Institute in London, England. | |
DIETMAR W. SIEMANN, Ph.D. (Chairman) is the John P. Cofrin Professor and Associate Chair for Research in Radiation Oncology at the University of Florida College of Medicine in Gainesville. In addition, he is a Professor in the schools Department of Pharmacology and Therapeutics. Dr. Siemann has authored more than 150 scientific papers and is the recipient of numerous scientific awards, including the Research Award of the Radiation Research Society in Oak Brook, Illinois (1990). He is the former Chairman of the National Cancer Institutes Radiation Study Section (1996-1998). |
EUGENE de JUAN, Jr., M.D. is a Professor of Ophthalmology at the Keck School of Medicine of the University of Southern California. Before joining the faculty of the Keck School, he served as the co-director of vitreoretinal service, director of the Microsurgery Advanced Design Laboratory and Joseph E. Green Professor of Ophthalmology at the Wilmer Eye Institute at Johns Hopkins University School of Medicine in Baltimore. From 1983 to 1992, he was a member of the medical staff of the Duke University Eye Center, holding joint teaching appointments with the Department of Ophthalmology and Department of Cell Biology. A graduate of the University of South Alabama College of Medicine, de Juan served an internship at University of South Alabama Medical Center, a residency at the Wilmer Ophthalmological Institute and a fellowship in vitreoretinal surgery at Duke University in Durham, North Carolina. He holds more than 20 patents. | |
JEFFREY S. HEIER, M.D., is a Vitreoretinal Specialist at Ophthalmic Consultants of Boston, Co-Director of the Vitreoretinal Fellowship at OCB/ Tufts Medical School, and President of the |
21
Center for Eye Research and Education in Boston, Massachusetts. Dr. Heiers academic appointments include an instructorship in ophthalmology at Tufts University School of Medicine and Harvard University Medical School, both in Boston. Dr. Heier received a medical degree from Boston University School of Medicine in Massachusetts, and subsequently completed a transitional internship, ophthalmic residency, and vitreoretinal fellowship at Fitzsimons Army Medical Center. Additional postgraduate training includes a vitreoretinal fellowship completed at Ophthalmic Consultants of Boston/ Tufts University School of Medicine. Dr. Heiers research interests are focused on age-related macular degeneration (ARMD), diabetic retinopathy, and innovation in vitreoretinal surgical instrumentation: areas he has pursued as lead or principal investigator in numerous clinical trials. | |
HAKAN MELLSTEDT, M.D., Ph.D. (Chairman) is Professor of Oncologic Biotherapy at the Karolinska Institute and Managing Director of Cancer Center Karolinska, Karolinska Institute, Stockholm, Sweden. He holds a position as Chief Physician at the Department of Oncology (Radiumhemmet), Karolinska Hospital, Stockholm, and has specialist certificates in Oncology, Hematology and Internal Medicine. He is a Member of the Board of Directors of ESMO (European Society for Medical Oncology) and a Member of ESMOs Executive Committee. Professor Mellstedt is currently a member of the Editorial Board of several international scientific journals and has published more than 450 articles in the areas of hematology, Contributions to Biomolecular Technologies. | |
LEE S. ROSEN, M.D. is the Director of Developmental Therapeutics for the Cancer Institute Medical Group, affiliated with the John Wayne Cancer Institute in Santa Monica. He is the former Adjunct Assistant Professor at UCLAs Department of Medicine, Division of Hematology-Oncology and served as Director of UCLAs Cancer Therapy Development Program from 1996-2002. Dr. Rosen serves as the principal investigator for many Phase I and II clinical trials, focusing on novel agents in general and the angiogenesis inhibitors in particular. | |
GORDON RUSTIN, M.D. is the Director of Medical Oncology at Mount Vernon Hospital, which is the largest cancer center in the South of England. He has published widely on management of gynecological cancers and germ cell tumors and the use of tumor markers. He has developed response criteria on CA125, which are now increasingly used in Phase II trials of ovarian cancer. He has recently been the principal investigator of two trials of vascular targeting agents, as well as several trials in ovarian cancer. He was awarded an Honorary Professorship by University College London in March 2001. | |
MARGARET A. TEMPERO, M.D. is Deputy Director of the University of California San Francisco Cancer Center and Professor and Chief of Medical Oncology in the School of Medicine. She is the former President of the American Society of Clinical Oncology (ASCO). She also has served on the Board of ASCO and is on the Board of Scientific Counselors, which is advisory to the intramural programs on the National Cancer Institute. She holds or has held editorial positions on numerous prestigious journals, such as Cancer Research, Journal of Clinical Oncology, Clinical Cancer Research and the American Journal of Medicine. She is also credited with over 100 original articles and book chapters. | |
JAN B. VERMORKEN, M.D., Ph.D. is a professor of Oncology and head of the Department of Medical Oncology of the University Hospital of the University of Antwerp, Belgium. Professor Vermorken has held numerous functions with the Dutch Cancer Society and the European Organization for Research on Treatment of Cancer (EORTC). He is a member of several EORTC study groups and presently is Secretary of the EORTC Head and Neck Cancer Group. Professor Vermorken has lectured extensively in the area of gynecological oncology and head and neck cancer, and currently serves on the editorial boards of several international journals. |
22
The creation of new blood vessels.
Treatment with drugs whose aim is the mitigation or cure of
diseases, such as cancer.
The thin layer of major blood vessels that lies between the
retina and sclera in the eye. The choroid supplies the retina
with oxygen and nutrients.
Chemical building blocks of genetic material.
A study in which neither the investigators assessing the outcome
of the trial nor the patients know whether the patient is
receiving the drug being investigated or merely a placebo. The
outcome can only be determined when the results are decoded.
Thin, flat cells that line the interior surface of blood
vessels. Their structure and functional integrity is fundamental
to maintaining a blood vessel wall.
An Investigational New Drug application filed with
the United States Food and Drug Administration that permits the
administration of compounds to humans in clinical trials.
An artificial environment created outside a living organism
(e.g., a test tube or culture plate) used in experimental
research to study a disease or process.
An experiment carried out in living organisms.
Cancer cell.
Living process of growth and reproduction.
A New Drug Application filed with the United States
Food and Drug Administration, which, if approved, allows a drug
to be marketed in the United States.
Cell death by decomposition.
A non-active substance given to a group of patients in a
clinical trial to duplicate the treatment method, but without
the administration of the active drug under investigation.
Physical energy that splits molecules and induces DNA damage.
The light sensitive portion of the back of the eye onto which
images are projected
A protein that forms the basic building blocks of microtubules.
Microtubules perform many functions inside the cell, including
helping to maintain endothelial cell shape.
ITEM 1A. | RISK FACTORS |
23
We have a history of losses and we anticipate that we will continue to incur losses in the future. |
Our products have not completed clinical trials, and may never demonstrate sufficient safety and efficacy in order to do so. |
We depend, and likely will continue to depend, on third parties for clinical development and manufacturing and marketing of our products. |
| collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; | |
| collaborators may not pursue further development and commercialization of our product candidates or may elect not to continue or renew research and development programs based on preclinical or clinical trial results, changes in their strategic focus or available funding, or external factors such as an acquisition that diverts resources or creates competing priorities; |
24
| collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; | |
| collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates or future products if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive; | |
| a collaborator with marketing and distribution rights to one or more products may not commit enough resources to their marketing and distribution; | |
| collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation; | |
| disputes may arise between us and the collaborators that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management attention and resources; and | |
| collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development of the applicable product candidates. |
If third parties on which we rely for clinical trials do not perform as contractually required or as we expect, we may not be able to obtain regulatory approval for or commercialize our product candidates. |
We have licensed in rights to CA4P, OXi4503 and other programs from third parties. If our license agreements terminate, we may lose the licensed rights to our product candidates, including CA4P and OXi4503, and we may not be able to continue to develop them or, if they are approved, market or commercialize them. |
25
We depend, and likely will continue to depend, on third parties for the manufacturing of our products. |
We will be required to raise additional funds to finance our operations; we may not be able to do so when necessary, and/or the terms of any financings may not be advantageous to us. |
26
Our products are subject to extensive government regulation, which results in uncertainties and delays in the progress of our products through the clinical trial process. |
27
The uncertainty associated with pharmaceutical reimbursement and related matters may adversely affect our business. |
Our industry is highly competitive, and our products may become technologically obsolete. |
We depend extensively on our patents and proprietary technology, and we must protect those assets in order to preserve our business. |
28
We depend heavily on our executive officers, directors, and principal consultants, and the loss of their services would materially harm our business. |
Our products may result in product liability exposure, and it is uncertain whether our insurance coverage will be sufficient to cover any claims. |
The price of our common stock is volatile, and is likely to continue to fluctuate due to reasons beyond our control. |
29
Our restated certificate of incorporation, our shareholder rights agreement and Delaware law could defer a change of our management which could discourage or delay offers to acquire us. |
ITEM 1B. | UNRESOLVED STAFF COMMENTS |
ITEM 2. | PROPERTIES |
ITEM 3. | LEGAL PROCEEDINGS |
ITEM 4. | SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS |
30
ITEM 5. | MARKET FOR REGISTRANTS COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES |
Fiscal Year 2005 | Fiscal Year 2004 | |||||||||||||||
High | Low | High | Low | |||||||||||||
First Quarter
|
$ | 6.12 | $ | 4.02 | $ | 11.34 | $ | 8.05 | ||||||||
Second Quarter
|
5.22 | 3.63 | 9.49 | 6.02 | ||||||||||||
Third Quarter
|
5.66 | 4.33 | 7.25 | 4.20 | ||||||||||||
Fourth Quarter
|
$ | 5.78 | $ | 3.89 | $ | 6.50 | $ | 5.21 |
31
ITEM 6. | SELECTED FINANCIAL DATA |
Years Ended December 31, | |||||||||||||||||||||
2001 | 2002 | 2003 | 2004 | 2005 | |||||||||||||||||
(Amounts in thousands, except per share amounts) | |||||||||||||||||||||
STATEMENT OF OPERATIONS DATA:
|
|||||||||||||||||||||
License revenue
|
$ | 8,953 | $ | | $ | 30 | $ | 7 | $ | 1 | |||||||||||
Operating costs and expenses:
|
|||||||||||||||||||||
Costs related to license revenue
|
1,508 | | | | | ||||||||||||||||
Research and development
|
6,430 | 5,201 | 4,036 | 5,947 | 7,098 | ||||||||||||||||
General and administrative
|
5,447 | 7,438 | 5,282 | 4,540 | 5,951 | ||||||||||||||||
Total operating costs and expenses
|
13,385 | 12,639 | 9,318 | 10,487 | 13,049 | ||||||||||||||||
Operating loss
|
(4,432 | ) | (12,639 | ) | (9,288 | ) | (10,480 | ) | (13,048 | ) | |||||||||||
Investment income
|
907 | 335 | 321 | 470 | 1,135 | ||||||||||||||||
Interest expense
|
(61 | ) | (53 | ) | (36 | ) | | | |||||||||||||
Other income (expense), net
|
(553 | ) | 1,344 | 635 | (14 | ) | 4 | ||||||||||||||
Net loss
|
$ | (4,139 | ) | $ | (11,013 | ) | $ | (8,368 | ) | $ | (10,024 | ) | $ | (11,909 | ) | ||||||
Basic and diluted net loss per common share
|
$ | (0.37 | ) | $ | (0.88 | ) | $ | (0.63 | ) | $ | (0.61 | ) | $ | (0.61 | ) | ||||||
Weighted average number of common shares outstanding
|
11,282 | 12,514 | 13,184 | 16,560 | 19,664 |
Years Ended December 31, | ||||||||||||||||||||
2001 | 2002 | 2003 | 2004 | 2005 | ||||||||||||||||
(Amounts in thousands) | ||||||||||||||||||||
BALANCE SHEET DATA:
|
||||||||||||||||||||
Cash, cash equivalents and available-for-sale securities
|
$ | 19,030 | $ | 11,830 | $ | 18,572 | $ | 30,502 | $ | 58,855 | ||||||||||
Working capital
|
16,309 | 8,446 | 15,250 | 21,457 | 52,221 | |||||||||||||||
Total assets
|
22,153 | 13,598 | 20,205 | 31,757 | 60,268 | |||||||||||||||
Total liabilities
|
3,634 | 3,578 | 3,735 | 2,622 | 3,734 | |||||||||||||||
Accumulated deficit
|
(60,641 | ) | (71,654 | ) | (80,022 | ) | (90,046 | ) | (101,955 | ) | ||||||||||
Total stockholders equity
|
$ | 18,519 | $ | 10,020 | $ | 16,470 | $ | 29,135 | $ | 56,534 |
32
ITEM 7. | MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Our Development Programs and Product Candidates |
33
Financial Resources |
| In June 2003, we completed a private placement with three large institutional investors. We received approximately $13,898,000 in net proceeds after deducting costs and expenses. The investors purchased 1,500,000 shares of our Common Stock at $10 per share and were issued two-year warrants to purchase up to an aggregate of 375,000 shares of our Common Stock at $15 per share, which expired in 2005. | |
| In January 2004, we received gross proceeds of approximately $24,200,000 from the sale of 2,755,695 shares of our Common Stock and net proceeds of approximately $22,359,000 after the |
34
deduction of fees and expenses, pursuant to a shelf registration statement on Form S-3 filed with the Securities and Exchange Commission in October 2003, allowing us to sell up to $50,000,000 of our Common Stock, debt securities and/or warrants to purchase our securities. | ||
| In March 2005, we received gross proceeds of approximately $15,000,000 from the sale of 3,336,117 shares of our Common Stock and net proceeds of approximately $13,719,000 after the deduction of fees and expenses, pursuant to the shelf registration statement referred to above. | |
| In December 2005, we received gross proceeds of approximately $27,284,000 from the sale of 7,475,000 shares of our Common Stock and net proceeds of approximately $25,205,000 after the deduction of fees and expenses, pursuant to a shelf registration statement on Form S-3 filed with the Securities and Exchange Commission in September 2005, allowing us to sell up to $75,000,000 of our Common Stock, debt securities and/or warrants to purchase our securities. |
Critical Accounting Policies and Significant Judgments and Estimates |
Available-for-Sale Securities |
Accrued Research and Development |
35
Impairment of Long-lived Assets |
Stock-Based Compensation |
36
Years ended December 31, 2005 and 2004 |
Revenues |
Costs and Expenses |
37
Other Income and Expenses |
Tax Matters |
Years ended December 31, 2004 and 2003 |
Revenues |
Costs and Expenses |
38
Other Income and Expenses |
39
Contractual Obligations |
Payments Due by Period | ||||||||||||||||||||
Less Than | 1-3 | 4-5 | After | |||||||||||||||||
Total | 1 Year | Years | Years | 5 Years | ||||||||||||||||
(All amounts in thousands) | ||||||||||||||||||||
Preclinical, chemistry and manufacturing and clinical
development commitments
|
5,080 | 4,539 | 522 | 19 | | |||||||||||||||
Operating leases
|
2,516 | 583 | 1,195 | 738 | | |||||||||||||||
Total contractual cash obligations
|
$ | 7,596 | $ | 5,122 | $ | 1,717 | $ | 757 | |
ITEM 7A. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
40
ITEM 8. | FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA |
ITEM 9. | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE |
ITEM 9A. | CONTROLS AND PROCEDURES |
Evaluation of our Disclosure Controls and Procedures |
Changes in Internal Control over Financial Reporting |
Management Report on Internal Control over Financial Reporting |
Important Considerations |
41
42
/s/ Ernst & Young LLP
Table of Contents
ITEM 9B. | OTHER INFORMATION |
ITEM 10. | DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT |
ITEM 11. | EXECUTIVE COMPENSATION |
ITEM 12. | SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS |
ITEM 13. | CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS |
ITEM 15. | EXHIBITS, FINANCIAL STATEMENT SCHEDULES |
(1) Financial Statements |
(2) Financial Statement Schedules |
(3) Exhibits |
43
Exhibit
Number
Description
3
.1
Restated Certificate of Incorporation of the Registrant.*
3
.2
Amended and Restated By-Laws of the Registrant.%
3
.3
Certificates of Amendment of Certificate of Incorporation, dated
June 21, 1995 and November 15, 1996.**
3
.4
Certificate of Amendment of Restated Certificate of
Incorporation, dated July 14, 2005.!
4
.1
Specimen Common Stock Certificate.*
4
.2
Form of Warrant, dated as of June 10, 2003, issued to Roth
Capital Partners, LLC.&&&
10
.1
OXiGENE 1996 Stock Incentive Plan, as amended.@
10
.2
Collaborative Research Agreement, dated as of August 1,
1997, between the Registrant and Boston Medical Center
Corporation.***
10
.3
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
.4
Office Lease, dated February 28, 2000, between Registrant
and Charles River Business Center Associates, L.L.C.###
10
.5
Research Collaboration and License Agreement, dated as of
December 15, 1999, between OXiGENE Europe AB and
Bristol-Myers Squibb Company.
10
.6
Employment Agreement between Registrant and Joel Citron dated as
of January 2, 2002.#@
10
.7
Termination Agreement by and between the Registrant and
Bristol-Myers Squibb Company, dated as of February 15,
2002.##
10
.8
Employment Agreement, dated as of October 23, 2000, between
Registrant and Frederick W. Driscoll.#@
10
.9
Independent Contractor Agreement For Consulting Services, dated
as of April 1, 2001, between Registrant and David Chaplin
Consultants, Ltd.#@
10
.10
Employment Agreement, dated as of April 1, 2001, between
Registrant and Dr. David Chaplin.#@
10
.11
Restricted Stock Agreement for Employees, dated as of
January 2, 2002, between Registrant and Dr. David
Chaplin.#
10
.12
Restricted Stock Agreement for Employees, dated as of
January 2, 2002, between Registrant and Frederick W.
Driscoll.#
10
.13
Form of Compensation Award Stock Agreement for Non-Employee
Directors, dated as of January 2, 2002.#
10
.14
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
.15
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
.16
Research and License Agreement between the Company and Baylor
University, dated June 1, 1999.&
10
.17
Agreement to Amend Research and License Agreement between the
Company and Baylor University, dated April 23, 2002.&
10
.18
Addendum to Research and License Agreement between
the Company and Baylor University, dated April 14,
2003.&
10
.19
License Agreement by and between Active Biotech AB
(Active) and the Company dated November 16,
2001.&
10
.20
License Agreement by and between Active and the Company dated
April 23, 2002.&
10
.21
Funded Research Agreement by and between the Company and The
Foundation Fighting Blindness, effective as of October 30,
2002.&&
44
Exhibit
Number
Description
10
.22
Stock Pledge and Loan Agreement, dated as of November 13,
2000, between Registrant and Per-Olof
Söderberg.&&&&
10
.23
Registration Rights Agreement, dated as of June 10, 2003,
among the Registrant and the Purchasers signatory
thereto.&&&
10
.24
Employment Agreement, dated as of February 23, 2004,
between the Registrant and James B. Murphy.%@
10
.25
Lease by and between The Realty Associates Fund III and the
Registrant, dated as of August 8, 2003.%%
10
.26
Sublease by and between Schwartz Communications, Inc. and the
Registrant, dated as of March 16, 2004.%%
10
.27
Stockholder Rights Agreement.!!
10
.28
OXiGENE 2005 Stock Plan.!!!
10
.29
Form of Incentive Stock Option Agreement under OXiGENE 2005
Stock Plan.
10
.30
Form of Non-Qualified Stock Option Agreement under OXiGENE 2005
Stock Plan.
10
.31
Form of Restricted Stock Agreement under OXiGENE 2005 Stock Plan.
10
.32
Description of Director Compensation Arrangement.!!!!
10
.33
Description of Named Executive Officers Compensation
Arrangements.!!!!
10
.34
Lease Modification Agreement No. 1 by and between The
Realty Associates Fund III and the Registrant, dated as of
May 25, 2005. !!!!
14
Corporate Code of Conduct and Ethics.####
23
Consent of Ernst & Young LLP.
31
.1
Certification of Chief Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
31
.2
Certification of Chief Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
32
Certification of Chief Executive and Financial Officers Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002.
*
Incorporated by reference to the Registrants Registration
Statement on
Form
S-1
(file
no.
33-64968)
and
any amendments thereto.
**
Incorporated by reference to the Registrants Annual Report
on Form
10-K
for
fiscal year ended December 31, 1996.
***
Incorporated by reference to the Registrants Annual Report
on Form
10-K
for
the fiscal year ended December 31, 1997.
****
Incorporated by reference to the Registrants Annual Report
on Form
10-K
for
the fiscal year ended December 31, 1999.
#
Incorporated by reference to the Registrants Quarterly
Report on
Form
10-Q
for the
quarterly period ended June 30, 2002.
##
Incorporated by reference to the Registrants Quarterly
Report on
Form
10-Q
for the
quarterly period ended March 31, 2002.
###
Incorporated by reference to the Registrants Annual Report
on Form
10-K
for
the fiscal year ended December 31, 2000.
####
Incorporated by reference to the Registrants Annual Report
on Form
10-K
for
the fiscal year ended December 31, 2002.
Incorporated by reference to the Registrants Registration
Statement on
Form
S-8
(file no.
333-92747)
and any
amendments thereto.
Incorporated by reference to the Registrants Current
Report on
Form
8-K,
filed on
December 28, 1999.
45
& | Incorporated by reference to Amendment No. 3 to the Registrants Annual Report on Form 10-K for the fiscal year ended December 31, 2002. | |
&& | Incorporated by reference to Amendment No. 4 to the Registrants Annual Report on Form 10-K for the fiscal year ended December 31, 2002. | |
&&& | Incorporated by reference to the Registrants Registration Statement on Form S-3 (file no. 333-106307) and any amendments thereto. | |
&&&& | Incorporated by reference to the Registrants Annual Report on Form 10-K for the fiscal year ended December 31, 2003. | |
% | Incorporated by reference to the Registrants Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2004. | |
%% | Incorporated by reference to the Registrants Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2004. | |
! | Incorporated by reference to the Registrants Registration Statement on Form S-8 (file no. 333-126636) and any amendments thereto. | |
!! | Incorporated by reference to the Registrants Registration Statement on Form 8-A, dated March 30, 2005 and any amendments thereto. | |
!!! | Incorporated by reference to the Registrants Current Report on Form 8-K, filed on July 11, 2005. | |
!!!! | Incorporated by reference to the Registrants Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2005. | |
| Confidential treatment requested as to certain portions of the document, which portions have been omitted and filed separately with the Securities and Exchange Commission. | |
@ | Management contract or compensatory plan or arrangement required to be filed as an exhibit to this Form 10-K pursuant to Item 15(a) of this report. |
46
47
OXiGENE, Inc.
By:
/s/
Frederick W. Driscoll
Frederick W. Driscoll
President and Chief Executive Officer
Signature
Title
Date
/s/
Joel-Tomas Citron
Joel-Tomas Citron
Chairman of the Board and Director
March 14, 2006
/s/
David Chaplin
David Chaplin
Chief Scientific Officer and Head of Research and Development,
Executive Vice Chairman of the Board and Director
March 14, 2006
/s/
Frederick W.
Driscoll
Frederick W. Driscoll
President, Chief Executive Officer and Director (Principal
executive officer)
March 14, 2006
/s/
James B. Murphy
James B. Murphy
Chief Financial Officer
(Principal financial officer)
March 14, 2006
/s/
Richard Chin
Richard Chin
Director
March 14, 2006
/s/
Arthur B. Laffer
Arthur B. Laffer
Director
March 14, 2006
/s/
William N. Shiebler
William N. Shiebler
Director
March 14, 2006
/s/
Per-Olof
Söderberg
Per-Olof Söderberg
Director
March 14, 2006
/s/
J. Richard Zecher
J. Richard Zecher
Director
March 14, 2006
Table of Contents
48
49
50
F-1
Exhibit
Number
Description
3
.1
Restated Certificate of Incorporation of the Registrant.*
3
.2
Amended and Restated By-Laws of the Registrant.%
3
.3
Certificates of Amendment of Certificate of Incorporation, dated
June 21, 1995 and November 15, 1996.**
3
.4
Certificate of Amendment of Restated Certificate of
Incorporation, dated July 14, 2005.!
4
.1
Specimen Common Stock Certificate*
4
.2
Form of Warrant, dated as of June 10, 2003, issued to Roth
Capital Partners, LLC.&&&
10
.1
OXiGENE 1996 Stock Incentive Plan, as amended.@
10
.2
Collaborative Research Agreement, dated as of August 1,
1997, between the Registrant and Boston Medical Center
Corporation.***
10
.3
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
.4
Office Lease, dated February 28, 2000, between Registrant
and Charles River Business Center Associates, L.L.C.###
10
.5
Research Collaboration and License Agreement, dated as of
December 15, 1999, between OXiGENE Europe AB and
Bristol-Myers Squibb Company.
10
.6
Employment Agreement between Registrant and Joel Citron dated as
of January 2, 2002.#@
10
.7
Termination Agreement by and between the Registrant and
Bristol-Myers Squibb Company, dated as of February 15,
2002.##
10
.8
Employment Agreement, dated as of October 23, 2000, between
Registrant and Frederick W. Driscoll.#@
10
.9
Independent Contractor Agreement For Consulting Services, dated
as of April 1, 2001, between Registrant and David Chaplin
Consultants, Ltd.#@
10
.10
Employment Agreement, dated as of April 1, 2001, between
Registrant and Dr. David Chaplin.#@
10
.11
Restricted Stock Agreement for Employees, dated as of
January 2, 2002, between Registrant and Dr. David
Chaplin.#
10
.12
Restricted Stock Agreement for Employees, dated as of
January 2, 2002, between Registrant and Frederick W.
Driscoll.#
10
.13
Form of Compensation Award Stock Agreement for Non-Employee
Directors, dated as of January 2, 2002.#
10
.14
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
.15
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
.16
Research and License Agreement between the Company and Baylor
University, dated June 1, 1999.&
10
.17
Agreement to Amend Research and License Agreement between the
Company and Baylor University, dated April 23, 2002.&
10
.18
Addendum to Research and License Agreement between
the Company and Baylor University, dated April 14,
2003.&
10
.19
License Agreement by and between Active Biotech AB
(Active) and the Company dated November 16,
2001.&
10
.20
License Agreement by and between Active and the Company dated
April 23, 2002.&
10
.21
Funded Research Agreement by and between the Company and The
Foundation Fighting Blindness, effective as of October 30,
2002.&&
Table of Contents
Exhibit
Number
Description
10
.22
Stock Pledge and Loan Agreement, dated as of November 13,
2000, between Registrant and Per-Olof
Söderberg.&&&&
10
.23
Registration Rights Agreement, dated as of June 10, 2003,
among the Registrant and the Purchasers signatory
thereto.&&&
10
.24
Employment Agreement, dated as of February 23, 2004,
between the Registrant and James B. Murphy.%@
10
.25
Lease by and between The Realty Associates Fund III and the
Registrant, dated as of August 8, 2003.%%
10
.26
Sublease by and between Schwartz Communications, Inc. and the
Registrant, dated as of March 16, 2004.%%
10
.27
Stockholder Rights Agreement.!!
10
.28
OXiGENE 2005 Stock Plan.!!!
10
.29
Form of Incentive Stock Option Agreement under OXiGENE 2005
Stock Plan.
10
.30
Form of Non-Qualified Stock Option Agreement under OXiGENE 2005
Stock Plan.
10
.31
Form of Restricted Stock Agreement under OXiGENE 2005 Stock Plan.
10
.32
Description of Director Compensation Arrangement.!!!!
10
.33
Description of Named Executive Officers Compensation
Arrangements.!!!!
10
.34
Lease Modification Agreement No. 1 by and between The
Realty Associates Fund III and the Registrant, dated as of
May 25, 2005. !!!!
14
Corporate Code of Conduct and Ethics.####
23
Consent of Ernst & Young LLP.
31
.1
Certification of Chief Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
31
.2
Certification of Chief Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
32
Certification of Chief Executive and Financial Officers Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002.
*
Incorporated by reference to the Registrants Registration
Statement on
Form
S-1
(file no.
33-64968)
and any
amendments thereto.
**
Incorporated by reference to the Registrants Annual Report
on Form
10-K
for
fiscal year ended December 31, 1996.
***
Incorporated by reference to the Registrants Annual Report
on Form
10-K
for
the fiscal year ended December 31, 1997.
****
Incorporated by reference to the Registrants Annual Report
on Form
10-K
for
the fiscal year ended December 31, 1999.
#
Incorporated by reference to the Registrants Quarterly
Report on
Form
10-Q
for the
quarterly period ended June 30, 2002.
##
Incorporated by reference to the Registrants Quarterly
Report on
Form
10-Q
for the
quarterly period ended March 31, 2002.
###
Incorporated by reference to the Registrants Annual Report
on Form
10-K
for
the fiscal year ended December 31, 2000.
####
Incorporated by reference to the Registrants Annual Report
on Form
10-K
for
the fiscal year ended December 31, 2002.
Incorporated by reference to the Registrants Registration
Statement on
Form
S-8
(file no.
333-92747)
and any
amendments thereto.
Incorporated by reference to the Registrants Current
Report on
Form
8-K,
filed on
December 28, 1999.
Table of Contents
&
Incorporated by reference to Amendment No. 3 to the
Registrants Annual Report on
Form
10-K
for the
fiscal year ended December 31, 2002.
&&
Incorporated by reference to Amendment No. 4 to the
Registrants Annual Report on
Form
10-K
for the
fiscal year ended December 31, 2002.
&&&
Incorporated by reference to the Registrants Registration
Statement on
Form
S-3
(file no.
333-106307)
and
any amendments thereto.
&&&&
Incorporated by reference to the Registrants Annual
Report on
Form
10-K
for the
fiscal year ended December 31, 2003.
%
Incorporated by reference to the Registrants Quarterly
Report on
Form
10-Q
for the
quarterly period ended March 31, 2004.
%%
Incorporated by reference to the Registrants Quarterly
Report on
Form
10-Q
for the
quarterly period ended June 30, 2004.
!
Incorporated by reference to the Registrants Registration
Statement on
Form
S-8
(file no.
333-126636)
and any
amendments thereto.
!!
Incorporated by reference to the Registrants Registration
Statement on
Form
8-A,
dated
March 30, 2005 and any amendments thereto.
!!!
Incorporated by reference to the Registrants Current
Report on
Form
8-K,
filed on
July 11, 2005.
!!!!
Incorporated by reference to the Registrants Quarterly
Report on
Form
10-Q
for the
quarterly period ended June 30, 2005.
Confidential treatment requested as to certain portions of the
document, which portions have been omitted and filed separately
with the securities and Exchange Commission.
@
Management contract or compensatory plan or arrangement required
to be filed as an exhibit to this
Form
10-K
pursuant
to Item 15(a) of this report.
F-2
F-3
F-4
F-5
F-6
F-7 F-21
Table of Contents
/s/ Ernst & Young LLP |
F-2
F-3
Year Ended December 31, | |||||||||||||
2003 | 2004 | 2005 | |||||||||||
(All amounts in thousands, | |||||||||||||
except per share amounts) | |||||||||||||
License revenue
|
$ | 30 | $ | 7 | $ | 1 | |||||||
Operating costs and expenses:
|
|||||||||||||
Research and development
|
4,036 | 5,947 | 7,098 | ||||||||||
General and administrative
|
5,282 | 4,540 | 5,951 | ||||||||||
Total operating costs and expenses
|
9,318 | 10,487 | 13,049 | ||||||||||
Operating loss
|
(9,288 | ) | (10,480 | ) | (13,048 | ) | |||||||
Investment income
|
321 | 470 | 1,135 | ||||||||||
Interest expense
|
(36 | ) | | | |||||||||
Other (expense) income, net
|
635 | (14 | ) | 4 | |||||||||
Net loss
|
$ | (8,368 | ) | $ | (10,024 | ) | $ | (11,909 | ) | ||||
Basic and diluted net loss per common share
|
$ | (0.63 | ) | $ | (0.61 | ) | $ | (0.61 | ) | ||||
Weighted-average number of common shares outstanding
|
13,184 | 16,560 | 19,664 |
F-4
Common Stock | Accumulated | |||||||||||||||||||||||||||||||
$.01 Par Value | Additional | Other | Total | |||||||||||||||||||||||||||||
Paid-in | Accumulated | Comprehensive | Notes | Deferred | Stockholders | |||||||||||||||||||||||||||
Shares | Amount | Capital | Deficit | Income (Loss) | Receivable | Compensation | Equity | |||||||||||||||||||||||||
(All amounts in thousands) | ||||||||||||||||||||||||||||||||
Balance at December 31, 2002
|
12,677 | $ | 127 | $ | 83,465 | $ | (71,654 | ) | $ | 637 | $ | (2,187 | ) | $ | (368 | ) | $ | 10,020 | ||||||||||||||
Unrealized loss from available-for-sale securities
|
| | | | (169 | ) | | | (169 | ) | ||||||||||||||||||||||
Foreign currency translation adjustment
|
| | | | (600 | ) | | | (600 | ) | ||||||||||||||||||||||
Net loss
|
| | | (8,368 | ) | | | | (8,368 | ) | ||||||||||||||||||||||
Comprehensive loss
|
| | | | | | | (9,137 | ) | |||||||||||||||||||||||
Issuance of common stock in connection with private financing,
net of expenses of $1,102
|
1,500 | 15 | 13,883 | | | | | 13,898 | ||||||||||||||||||||||||
Issuance of common stock upon exercise of options
|
110 | 1 | 499 | | | | | 500 | ||||||||||||||||||||||||
Compensation related to restricted stock, options and stock
appreciation rights
|
5 | | 229 | | | | 391 | 620 | ||||||||||||||||||||||||
Payment of notes receivable
|
| | | | | 569 | | 569 | ||||||||||||||||||||||||
Interest on notes receivable
|
| | 102 | | | (102 | ) | | | |||||||||||||||||||||||
Cancellation of notes receivable
|
(298 | ) | (3 | ) | (755 | ) | | | 758 | | | |||||||||||||||||||||
Options issued for services provided by non-employees
|
| | 251 | | | | (251 | ) | | |||||||||||||||||||||||
Balance at December 31, 2003
|
13,994 | 140 | 97,674 | (80,022 | ) | (132 | ) | (962 | ) | (228 | ) | 16,470 | ||||||||||||||||||||
Unrealized gain from available-for-sale securities
|
| | | | 38 | | | 38 | ||||||||||||||||||||||||
Net loss
|
| | | (10,024 | ) | | | | (10,024 | ) | ||||||||||||||||||||||
Comprehensive loss
|
| | | | | | | (9,986 | ) | |||||||||||||||||||||||
Issuance of common stock in connection with private financing,
net of expenses of $1,837
|
2,756 | 27 | 22,332 | | | | | 22,359 | ||||||||||||||||||||||||
Issuance of common stock upon exercise of options
|
20 | | 52 | | | | | 52 | ||||||||||||||||||||||||
Compensation related to restricted stock
|
(9 | ) | | (26 | ) | | | | 156 | 130 | ||||||||||||||||||||||
Payment of notes receivable
|
| | | | | 82 | | 82 | ||||||||||||||||||||||||
Interest on notes receivable
|
| | 21 | | | (21 | ) | | | |||||||||||||||||||||||
Cancellation of notes receivable
|
(47 | ) | | (517 | ) | | | 517 | | | ||||||||||||||||||||||
Options issued for services provided by non-employees
|
| | (9 | ) | | | | 37 | 28 | |||||||||||||||||||||||
Balance at December 31, 2004
|
16,714 | 167 | 119,527 | (90,046 | ) | (94 | ) | (384 | ) | (35 | ) | 29,135 | ||||||||||||||||||||
Unrealized gain from available-for-sale securities
|
| | | | 9 | | | 9 | ||||||||||||||||||||||||
Net loss
|
| | | (11,909 | ) | | | | (11,909 | ) | ||||||||||||||||||||||
Comprehensive loss
|
| | | | | | | (11,900 | ) | |||||||||||||||||||||||
Issuance of common stock in connection with equity financings,
net of expenses of $3,372
|
10,811 | 108 | 38,816 | | | | | 38,924 | ||||||||||||||||||||||||
Issuance of common stock upon exercise of options
|
3 | | 10 | | | | | 10 | ||||||||||||||||||||||||
Issuance of restricted stock
|
520 | 5 | 2,691 | | | | (2,696 | ) | | |||||||||||||||||||||||
Compensation related to restricted stock
|
| | | | | | 303 | 303 | ||||||||||||||||||||||||
Payment of notes receivable
|
| | | | | 57 | | 57 | ||||||||||||||||||||||||
Interest on notes receivable
|
| | 11 | | | (11 | ) | | | |||||||||||||||||||||||
Cancellation of notes receivable
|
(11 | ) | | (151 | ) | | | 151 | | | ||||||||||||||||||||||
Options issued for services provided by non-employees
|
| | (19 | ) | | | | 24 | 5 | |||||||||||||||||||||||
Balance at December 31, 2005
|
28,037 | $ | 280 | $ | 160,885 | $ | (101,955 | ) | $ | (85 | ) | $ | (187 | ) | $ | (2,404 | ) | $ | 56,534 | |||||||||||||
F-5
Year Ended December 31, | |||||||||||||
2003 | 2004 | 2005 | |||||||||||
(Amounts in thousands) | |||||||||||||
Operating activities:
|
|||||||||||||
Net loss
|
$ | (8,368 | ) | $ | (10,024 | ) | $ | (11,909 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|||||||||||||
Foreign currency translation gain
|
(635 | ) | | | |||||||||
Depreciation
|
478 | 27 | 44 | ||||||||||
Amortization of license agreements
|
98 | 98 | 98 | ||||||||||
Compensation expense related to issuance of warrants, options,
stock appreciation rights and restricted stock
|
620 | 158 | 308 | ||||||||||
Changes in operating assets and liabilities:
|
|||||||||||||
Restricted cash
|
(364 | ) | 364 | | |||||||||
Prepaid expenses and other current assets
|
(7 | ) | (56 | ) | (151 | ) | |||||||
Accounts payable, accrued expenses and other payables
|
427 | (958 | ) | 1,112 | |||||||||
Net cash used in operating activities
|
(7,751 | ) | (10,391 | ) | (10,498 | ) | |||||||
Investing activities:
|
|||||||||||||
Purchase of available-for-sale securities
|
(10,584 | ) | (9,777 | ) | (33,392 | ) | |||||||
Proceeds from sale of available-for-sale securities
|
798 | 12,995 | 21,404 | ||||||||||
Amount paid for license agreements
|
(290 | ) | (155 | ) | | ||||||||
Purchase of furniture, fixtures and equipment
|
(35 | ) | (50 | ) | (112 | ) | |||||||
Deposits
|
(33 | ) | (5 | ) | (37 | ) | |||||||
Net cash provided by (used in) investing activities
|
(10,144 | ) | 3,008 | (12,137 | ) | ||||||||
Financing activities:
|
|||||||||||||
Proceeds from issuance of common stock
|
14,398 | 22,411 | 38,934 | ||||||||||
Payment of notes receivable and related interest
|
569 | 82 | 57 | ||||||||||
Net cash provided by financing activities
|
14,967 | 22,493 | 38,991 | ||||||||||
Effect of exchange rate changes on cash
|
54 | | | ||||||||||
Increase (Decrease) in cash and cash equivalents
|
(2,874 | ) | 15,110 | 16,356 | |||||||||
Cash and cash equivalents at beginning of year
|
3,752 | 878 | 15,988 | ||||||||||
Cash and cash equivalents at end of year
|
$ | 878 | $ | 15,988 | $ | 32,344 | |||||||
Supplemental Disclosure
|
|||||||||||||
Interest paid
|
$ | 30 | | |
F-6
1. | Description of Business and Significant Accounting Policies |
Description of Business |
Basis of Presentation |
Use of Estimates |
Concentration of Credit Risk |
Cash and Cash Equivalents |
F-7
Available-for-Sale Securities |
December 31, 2005 | ||||||||||||||||||
Gross | Gross | |||||||||||||||||
Unrealized | Unrealized | |||||||||||||||||
Cost | Gains | Losses | Fair Value | |||||||||||||||
Current
|
||||||||||||||||||
Government bonds and notes
|
||||||||||||||||||
Maturing in less than 2 years
|
$ | 3,782 | $ | | $ | (1 | ) | $ | 3,781 | |||||||||
Corporate bonds
|
||||||||||||||||||
Maturing in less than 2 years
|
4,806 | | (28 | ) | 4,778 | |||||||||||||
Maturing in 2 to 4 years
|
1,203 | | | 1,203 | ||||||||||||||
Subtotal corporate bonds
|
6,009 | | (28 | ) | 5,981 | |||||||||||||
Commercial Paper
|
9,334 | | (1 | ) | 9,333 | |||||||||||||
Asset backed securities
|
3,268 | | (8 | ) | 3,260 | |||||||||||||
Certificates of deposit
|
1,000 | | | 1,000 | ||||||||||||||
Subtotal current available-for-sale securities
|
23,393 | | (38 | ) | 23,355 | |||||||||||||
Long Term
|
||||||||||||||||||
Government bonds and notes
|
||||||||||||||||||
Maturing in less than 2 years
|
1,500 | | (28 | ) | 1,472 | |||||||||||||
Corporate bonds
|
||||||||||||||||||
Maturing in less than 2 years
|
1,703 | | (19 | ) | 1,684 | |||||||||||||
Subtotal long term available-for-sale securities
|
3,203 | | (47 | ) | 3,156 | |||||||||||||
Total available-for-sale securities
|
$ | 26,596 | $ | | $ | (85 | ) | $ | 26,511 | |||||||||
F-8
December 31, 2004
Gross
Gross
Unrealized
Unrealized
Cost
Gains
Losses
Fair Value
$
752
$
$
(8
)
$
744
950
2
(6
)
946
2,052
(9
)
2,043
4,253
4,253
8,007
2
(23
)
7,986
1,500
(3
)
1,497
1,000
1,000
2,500
(3
)
2,497
1,751
(24
)
1,727
1,741
(35
)
1,706
3,492
(59
)
3,433
609
(11
)
598
6,601
(73
)
6,528
$
14,608
$
2
$
(96
)
$
14,514
Accrued Research and Development |
F-9
Income Taxes |
License Agreement |
Depreciation |
Patents and Patent Applications |
Foreign Currency Translation |
F-10
Net Loss Per Share |
Stock-Based Compensation |
Weighted Average Assumptions | 2003 | 2004 | 2005 | |||||||||
Risk-free interest rate
|
3.16 | % | 2.57 | % | 4.19 | % | ||||||
Expected life
|
4 years | 4 years | 4 years | |||||||||
Expected volatility
|
95 | % | 118 | % | 133 | % | ||||||
Dividend yield
|
0.00 | % | 0.00 | % | 0.00 | % |
F-11
Year Ended December 31,
2003
2004
2005
$
(8,368
)
$
(10,024
)
$
(11,909
)
112
129
303
(909
)
(2,250
)
(1,814
)
$
(9,165
)
$
(12,145
)
$
(13,420
)
$
(0.63
)
$
(0.61
)
$
(0.61
)
$
(0.70
)
$
(0.73
)
$
(0.68
)
Comprehensive Income (Loss) |
Revenue Recognition |
F-12
Recent Accounting Pronouncements |
F-13
2. | Foreign Operations |
December 31, 2003 | ||||
Assets
|
$ | | ||
Liabilities
|
| |||
Expenses
|
136 | |||
Net (loss) income
|
$ | (165 | ) |
3. | Related Party Transactions |
4. | Stockholders Equity |
F-14
Stock Incentive Plans |
Stock Appreciation Rights |
F-15
Options and Warrants |
Stock | |||||||||||||
Non-Qualified | Appreciation | ||||||||||||
Stock Options | Rights | Warrants | |||||||||||
Outstanding at December 31, 2002
|
590 | 25 | | ||||||||||
Granted
|
919 | | 525 | ||||||||||
Exercised
|
(98 | ) | (17 | ) | | ||||||||
Canceled
|
(29 | ) | (8 | ) | | ||||||||
Outstanding at December 31, 2003
|
1,382 | | 525 | ||||||||||
Granted
|
378 | | | ||||||||||
Exercised
|
(20 | ) | | | |||||||||
Canceled
|
(146 | ) | | | |||||||||
Outstanding at December 31, 2004
|
1,594 | | 525 | ||||||||||
Granted
|
133 | | | ||||||||||
Exercised
|
(4 | ) | | | |||||||||
Canceled
|
(51 | ) | | (375 | ) | ||||||||
Outstanding at December 31, 2005
|
1,672 | | 150 |
F-16
Stock
Non-Qualified
Appreciation
Stock Options
Rights
Warrants
$
3.14
$
7.51
$
8.58
14.14
3.79
7.63
4.07
7.25
6.69
14.14
6.21
2.58
8.64
$
6.45
$
$
14.14
4.89
2.96
7.43
15.00
$
6.31
$
$
12.00
Non-qualified
Stock
Options
Warrants
(Share amounts in
thousands)
462
525
$
2.96
$
14.14
746
525
$
5.33
$
14.14
1,119
150
$
6.19
$
12.00
F-17
Non-qualified Stock Options
Warrants
(Share amounts in thousands)
$
1.06 to $5.00
$
5.01 to $10.35
$
12.00 to $15.00
497
1,175
150
$
2.94
$
7.73
$
12.00
6.58 years
7.95 years
2.44 years
412
707
150
$
2.70
$
8.23
$
12.00
Notes Receivable |
Common Stock Reserved for Issuance |
5. | Income Taxes |
F-18
2004
2005
$
35,058
(1)
$
39,641
70
(60
)
232
622
35,360
40,203
$
(35,360
)
$
(40,203
)
(1) | This amount for the year ended December 31, 2004 was originally reported as $44,324,000 and has been adjusted to exclude foreign net operating loss carryforwards, which are not available due to the liquidation of OXiGENE Europe AB. |
6. | Commitments and Contingencies |
Leases |
F-19
Gross
Receipts from
Net
Commitments
Sublease
Commitments
$
583
$
(210
)
$
373
593
(211
)
382
602
(143
)
459
441
441
297
297
$
2,516
$
(564
)
$
1,952
License Agreements |
Litigation |
7. | Retirement Savings Plan |
F-20
8.
Quarterly Results of Operations (Unaudited)
Three Months Ended,
March 31,
June 30,
September 30,
December 31,
2004
2004
2004
2004
$
7
$
$
$
(2,062
)
(2,803
)
(2,910
)
(2,249
)
$
(0.13
)
$
(0.17
)
$
(0.17
)
$
(0.13
)
Three Months Ended,
March 31,
June 30,
September 30,
December 31,
2005
2005
2005
2005
$
$
$
$
1
(2,028
)
(3,058
)
(3,444
)
(3,379
)
$
(0.12
)
$
(0.15
)
$
(0.17
)
$
(0.16
)
F-21
1.
|
Name and Address of Employee: | |||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
2.
|
Date of Grant: | |||
|
||||
|
||||
3.
|
Type of Grant: | Incentive Stock Option | ||
|
||||
4.
|
Maximum Number of Shares for | |||
|
which this Option is exercisable: | |||
|
||||
|
||||
5.
|
Exercise (purchase) price per share: | |||
|
OXiGENE, INC. | ||||||
|
||||||
|
By: | |||||
Name: | ||||||
|
||||||
Title: | ||||||
|
||||||
|
||||||
Employee |
2
(a) | to the extent that the Option has become exercisable but has not been exercised as of the date of Disability; and | ||
(b) | in the event rights to exercise the Option accrue periodically, to the extent of a pro rata portion through the date of Disability of any additional vesting rights that would have accrued on the next vesting date had the Employee not become Disabled. The proration shall be based upon the number of days accrued in the current vesting period prior to the date of Disability. |
3
(x) | to the extent that the Option has become exercisable but has not been exercised as of the date of death; and | ||
(y) | in the event rights to exercise the Option accrue periodically, to the extent of a pro rata portion through the date of death of any additional vesting rights that would have accrued on the next vesting date had the Employee not died. The proration shall be based upon the number of days accrued in the current vesting period prior to the Employees date of death. |
4
5
(a) | The person(s) who exercise the Option shall warrant to the Company, at the time of such exercise, that such person(s) are acquiring such Shares for their own respective accounts, for investment, and not with a view to, or for sale in connection with, the distribution of any such Shares, in which event the person(s) acquiring such Shares shall be bound by the provisions of the following legend which shall be endorsed upon the certificate(s) evidencing the Shares issued pursuant to such exercise: |
(b) | If the Company so requires, the Company shall have received an opinion of its counsel that the Shares may be issued upon such particular exercise in compliance with the 1933 Act without registration thereunder. Without limiting the generality of the foregoing, the Company may delay issuance of the Shares until completion of any action or obtaining of any consent, which the Company deems necessary under any applicable law (including without limitation state securities or blue sky laws). |
6
7
8
9
OXiGENE, INC. | ||||
|
||||
|
By: | |||
|
||||
|
Name:
Title: |
|||
|
||||
EMPLOYEE | ||||
|
||||
Signature | ||||
|
||||
Print Name |
10
A-1
|
Very truly yours, | |
|
||
|
||
|
Employee (signature) | |
|
||
|
||
|
Print Name | |
|
||
|
||
|
Date | |
|
||
|
||
|
Social Security Number |
1.
|
Name and Address of Participant: | |||
|
||||
2.
|
Date of Grant: | |||
|
||||
3.
|
Type of Grant: | Non-Qualified Stock Option | ||
|
||||
4.
|
Maximum Number of Shares for which this Option is exercisable: | |||
|
||||
5.
|
Exercise (purchase) price per share: | |||
|
||||
6. | Vesting Schedule: This Option shall become exercisable (and the Shares issued upon exercise shall be vested) as follows: |
Vest Date | Number of Options Vesting | |||
OXiGENE, INC. | ||||||
|
||||||
|
By: | |||||
|
||||||
|
||||||
|
Name: | James Murphy | ||||
|
Title: | Vice President and Chief Financial Officer | ||||
|
||||||
Participant |
2
(a) | to the extent that the Option has become exercisable but has not been exercised as of the date of Disability; and | ||
(b) | in the event rights to exercise the Option accrue periodically, to the extent of a pro rata portion through the date of Disability of any additional vesting rights that would have accrued on the next vesting date had the Participant not become Disabled. The proration shall be based upon the number of days accrued in the current vesting period prior to the date of Disability. |
3
(x) | to the extent that the Option has become exercisable but has not been exercised as of the date of death; and | ||
(y) | in the event rights to exercise the Option accrue periodically, to the extent of a pro rata portion through the date of death of any additional vesting rights that would have accrued on the next vesting date had the Participant not died. The proration shall be based upon the number of days accrued in the current vesting period prior to the Participants date of death. |
4
5
(a) | The person(s) who exercise the Option shall warrant to the Company, at the time of such exercise, that such person(s) are acquiring such Shares for their own respective accounts, for investment, and not with a view to, or for sale in connection with, the distribution of any such Shares, in which event the person(s) acquiring such Shares shall be bound by the provisions of the following legend which shall be endorsed upon the certificate(s) evidencing the Shares issued pursuant to such exercise: |
The shares represented by this certificate have been taken for investment and they may not be sold or otherwise transferred by any person, including a pledgee, unless (1) either (a) a Registration Statement with respect to such shares shall be effective under the Securities Act of 1933, as amended, or (b) the Company shall have received an opinion of counsel satisfactory to it that an exemption from registration under such Act is then available, and (2) there shall have been compliance with all applicable state securities laws; and |
(b) | If the Company so requires, the Company shall have received an opinion of its counsel that the Shares may be issued upon such particular exercise in compliance with the 1933 Act without registration thereunder. Without limiting the generality of the foregoing, the Company may delay issuance of the Shares until completion of any action or obtaining of any consent, which the Company deems necessary under any applicable law (including without limitation state securities or blue sky laws). |
6
If to the Company:
|
||
|
At its principal business office listed on the first page of this Agreement | |
|
||
If to the Participant:
|
||
|
At the address set forth on Schedule A |
7
8
OXiGENE, INC. | ||||
|
||||
|
By: | |||
|
||||
|
||||
|
Name: | James Murphy | ||
|
Title: | Vice President and Chief Financial Officer | ||
|
||||
PARTICIPANT | ||||
|
||||
Signature | ||||
|
||||
Print Name |
9
|
Very truly yours, | |
|
||
|
||
|
Employee (signature) | |
|
||
|
||
|
Print Name | |
|
||
|
||
|
Date | |
|
||
|
||
|
Social Security Number |
2
3
4
1 | If the Shares are purchased at fair market value then the 83(b) election would be protective in nature and would not result in any additional tax on purchase of the Shares. If the Shares are being purchased at a discount from fair market value, the 83(b) election accelerates the timing of the taxation to the time of the grant, and later dispositions are taxed at capital gain rates. If the 83(b) election is not made then the tax is paid at the time the restrictions lapse (which could result in a higher possible taxable spread at that time). An 83(b) election must be made within 30 days of the grant. | |
If the Company pays cash dividends and an 83(b) election is filed, dividends receive dividend tax treatment. However, if no 83(b) election is made (as is the case with most public companies) the Employee will pay ordinary income tax rates on the cash dividend payments until the restrictions on the shares underlying those dividends lapse. | ||
If no 83(b) election is filed consider adding the following to the Agreement: The Participant has agreed not to file an election with respect to the Granted Shares under Section 83 of the Code and has obtained the advice or has been given the opportunity to obtain the advice of his or her tax advisors with respect to the tax consequences of the purchase of the Granted Shares and the provisions of this Agreement. |
5
6
7
OXiGENE, INC. | ||||||
|
||||||
|
By: | |||||
|
||||||
Name: James Murphy | ||||||
Title: Vice President and Chief Financial Officer | ||||||
|
||||||
Participant: | ||||||
|
||||||
|
||||||
Print Name: | ||||||
|
||||||
Date
Signed:
|
8
|
|
A-1
1. | The name, address and social security number of the undersigned are: |
2. | The description of the property with respect to which the election is being made is as follows: | |
( ) shares (the Shares) of Common Stock, $0.01 par value per share, of OXiGENE, Inc., a Delaware corporation (the Company). | ||
3. | This election is made for the calendar year ___, with respect to the transfer of the property to the Taxpayer on . | |
4. | Description of restrictions: The property is subject to the following restrictions: | |
In the event taxpayers employment with the Company or an Affiliate is terminated, the Company may repurchase all or any portion of the Shares determined as set forth below at the acquisition price paid by the taxpayer: |
A. | If the termination takes place on or prior to , the Purchase Option will apply to all of the Shares. | ||
B. | If the termination takes place after , 200_, the number of Shares to which the Purchase Option applies shall be ( ) Shares less ( ) Shares for each full twelve (12) month period elapsed after , 200___ if the taxpayer is employed by the Company or an Affiliate. |
5. | The fair market value at time of transfer (determined without regard to any restrictions other than restrictions which by their terms will never lapse) of the property with respect to which this election is being made was not more than $ per Share. | |
6. | The amount paid by taxpayer for said property was $ per Share. | |
7. | A copy of this statement has been furnished to the Company. |
|
|
B-2
|
By: | /s/ Frederick W. Driscoll | ||||
|
|
|||||
|
Chief Executive Officer |
|
By: |
/s/
James B. Murphy
|
||||
|
Chief Financial Officer |
Dated:
March 14, 2006
|
/s/ Frederick W. Driscoll
|
|||
|
||||
Dated:
March 14, 2006
|
/s/ James B. Murphy
|