As filed with the Securities and Exchange Commission on November 19, 1996
Registration No. 333-15241
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
OXiGENE, INC.
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(Exact name of registrant as specified in its charter)
Delaware
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(State or other jurisdiction of incorporation or organization)
13-3679168
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(I.R.S. Employer Identification No.)
110 East 59th Street, New York, NY 10022, (212) 421-0001
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(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
M. Andica Kunst, Esq., 110 East 59th Street, New York, NY 10022, (212) 421-0001
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(Name, Address, including zip code, and telephone number, including area code,
of agent for service)
Approximate date of commencement of proposed sale to
the public: From time to time after the effective date of
this Registration Statement.
If the only securities being registered on this Form are being offered pursuant
to dividend or interest reinvestment plans, please check the following box. / /
If any of the securities being registered on this Form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or
interest reinvestment plans, check the following box. /X/
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following
box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. / /
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. / /
The Registrant hereby amends this Registration Statement on such date
or dates as may be necessary to delay its effective date until the Registrant
shall file a further amendment which specifically states that this Registration
Statement shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
<PAGE>
OXiGENE, INC.
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CROSS REFERENCE SHEET
Pursuant to Item 501(b) of Regulation S-K
Between Items Required in Part I of Registration Statement
(Form S-3) and Information in Prospectus
<TABLE>
<CAPTION>
Item
No. Form S-3 Caption Prospectus Page or Caption
<S> <C> <C>
1. Forepart of Registration Statement and Outside
Front Cover Page of Prospectus.......................... Outside Front Cover Page of
Prospectus
2. Inside Front and Outside Back Cover Pages of
Prospectus.............................................. Inside Front and Outside Back
Cover Pages of Prospectus
3. Summary Information, Risk Factors and Ratio of
Earnings to Fixed Charges............................... The Company; Risk Factors
4. Use of Proceeds............................................... N/A
5. Determination of Offering Price............................... Plan of Distribution
6. Dilution...................................................... N/A
7. Selling Security Holders...................................... Selling Security Holders
8. Plan of Distribution.......................................... Outside Front Cover Page of
Prospectus; Plan of Distribution
9. Description of Securities to be Registered.................... N/A
10. Interests of Named Experts and Counsel........................ Legal Matters; Experts
11. Material Changes.............................................. N/A
12. Incorporation of Certain Information by
Reference................................................... Incorporation by Reference
13. Disclosure of Commission Position on
Indemnification for Securities Act Liabilities.......... N/A
</TABLE>
411551.6
<PAGE>
PROSPECTUS
386,000 Shares of Common Stock
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OXiGENE, INC.
----------------------
This Prospectus relates to the public offering and sale by certain holders
(the "Selling Securityholders") of up to 386,000 shares of Common Stock, par
value $.01 per share ("Common Stock") of OXiGENE, Inc., a Delaware corporation
("OXiGENE" or the "Company"), all of which are issuable upon exercise of
options and warrants to purchase shares of Common Stock (collectively, the
"Warrants").
The shares of Common Stock offered hereby may be offered for resale by the
Selling Securityholders (or their donees) from time to time in transactions for
their own account (which may include block transactions) in the
over-the-counter market, in negotiated transactions, through the writing of
options on the shares, or a combination of such methods of sale, at fixed
prices (which may be changed), at market prices prevailing at the time of sale,
at prices related to such prevailing market prices or at negotiated prices. The
Selling Securityholders may effect such transactions by selling the shares of
Common Stock to or through broker-dealers, and such broker-dealers may receive
compensation in the form of discounts, concessions or commissions from the
Selling Securityholders and/or the purchasers of shares for whom such
broker-dealers may act as agent or to whom they sell as principal, or both
(which compensation as to a particular broker-dealer might be in excess of
customary commissions). See "Plan of Distribution."
The shares of Common Stock are being offered for the accounts of the
Selling Securityholders. The Company will receive the proceeds of any exercise
of the Warrants, but will not receive any proceeds from the sale of the shares
of Common Stock by the Selling Securityholders. It is not possible at the
present time to determine the price to the public in any sale of the shares of
Common Stock by the Selling Securityholders and each Selling Securityholder
reserves the right to accept or reject, in whole or in part, any proposed
purchase of shares of Common Stock. Accordingly, the public offering price and
the amount of any applicable underwriting discounts and commissions will be
determined at the time of such sale by the Selling Securityholders. The
aggregate proceeds to the Selling Securityholders from the sale of the shares
of Common Stock will be the purchase price of the shares of Common Stock sold
less all applicable commissions and underwriters' discounts, if any. The
Company will pay substantially all of the expenses of the offering of the
shares of Common Stock by Selling Securityholders. See "Selling Security
Holders" and "Plan of Distribution."
The shares of Common Stock of the Company are traded on The Nasdaq Stock
Market, Inc. ("Nasdaq") SmallCap Market under the symbol "OXGN." The closing
asked price of the Company's Common Stock as reported by Nasdaq on October 28,
1996 was $25.00.
The Securities Offered Hereby Involve a High Degree of Risk. See "Risk Factors."
-----------------------------------
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES
COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF
THIS PROSPECTUS. ANY REPRESENTATION TO THE
CONTRARY IS A CRIMINAL OFFENSE.
-----------------------------------
The date of this Prospectus is November 19, 1996.
411551.6
<PAGE>
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the U.S.
Securities Exchange Act of 1934 (the "Exchange Act"), and in accordance
therewith files reports, proxy and information statements and other information
with the United States Securities and Exchange Commission (the "SEC"). Copies
of such reports, proxy and information statements and other information can be
inspected and copied at the public reference facilities maintained by the SEC
at Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C. 20549 and at the
following Regional Offices of the SEC: Northwestern Atrium Center, 500 West
Madison Street, Suite 1400, 14th Floor, Chicago, Illinois 60661; and Seven
World Trade Center, 13th Floor, New York, New York 10048. Copies of such
material can be obtained at prescribed rates from the Public Reference Section
of the SEC, 450 Fifth Street, N.W., Washington, D.C. 20549. The SEC maintains a
Web site that contains reports, proxy and information statements and other
information regarding registrants that file electronically with the SEC,
including the Company, and the address is (http://www.sec.gov).
The Company has filed with the SEC a registration statement on Form S-3
(together with any amendments thereto, the "Registration Statement") under the
Securities Act of 1933 (the "Securities Act"), with respect to the shares of
Common Stock to be offered pursuant to this Prospectus. This Prospectus is part
of the Registration Statement and does not contain all the information set
forth in the Registration Statement, certain portions of which have been
omitted pursuant to the rules and regulations of the SEC. Such additional
information may be obtained from the SEC's principal office in Washington, D.C.
Statements contained in this Prospectus or in any document incorporated by
reference in this Prospectus as to the contents of any contract or other
document referred to herein or therein are not necessarily complete, and in
each instance reference is made to the copy of such contract or other document
filed as an exhibit to the Registration Statement or such other document, each
such statement being qualified in all respects by such reference.
EXCEPT FOR HISTORICAL INFORMATION CONTAINED HEREIN, THIS REGISTRATION STATEMENT
CONTAINS FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF THE U.S. PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995. THESE STATEMENTS INVOLVE KNOWN AND
UNKNOWN RISKS AND UNCERTAINTIES THAT MAY CAUSE THE COMPANY'S ACTUAL RESULTS OR
OUTCOMES TO BE MATERIALLY DIFFERENT FROM THOSE ANTICIPATED AND DISCUSSED
HEREIN. FURTHER, THE COMPANY OPERATES IN AN INDUSTRY SECTOR WHERE SECURITIES
VALUES MAY BE VOLATILE AND MAY BE INFLUENCED BY REGULATORY AND OTHER FACTORS
BEYOND THE COMPANY'S CONTROL. IMPORTANT FACTORS THAT THE COMPANY BELIEVES MIGHT
CAUSE SUCH DIFFERENCES ARE DISCUSSED IN THE CAUTIONARY STATEMENTS ACCOMPANYING
THE FORWARD-LOOKING STATEMENTS AND IN THE RISK FACTORS CONTAINED IN THIS
PROSPECTUS AND IN THE RISK FACTORS DETAILED IN THE COMPANY'S OTHER FILINGS WITH
THE SEC DURING THE PAST 12 MONTHS. IN ASSESSING FORWARD-LOOKING STATEMENTS
CONTAINED HEREIN, READERS ARE URGED TO READ CAREFULLY ALL RISK FACTORS AND
CAUTIONARY STATEMENTS CONTAINED IN THIS PROSPECTUS AND IN THOSE OTHER FILINGS
WITH THE SEC.
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411551.6
<PAGE>
INCORPORATION BY REFERENCE
This Prospectus incorporates by reference certain documents that are not
presented herein or delivered herewith. These documents are available upon
request from M. Andica Kunst, Esq., Vice President and Corporate Secretary,
OXiGENE, Inc., 110 East 59th Street, New York, New York 10022, telephone (212)
421-0001, fax (212) 421-0475.
The Company hereby undertakes to provide without charge to each person to
whom a copy of this Prospectus has been delivered, upon the written or oral
request of any such person, a copy of any and all of the documents referred to
below which have been or may be incorporated herein by reference, other than
exhibits to such documents, unless such exhibits are specifically incorporated
herein by reference. Requests for such documents should be directed to the
person indicated in the immediately preceding paragraph.
The following documents, which have been filed with the SEC pursuant to the
Exchange Act, are hereby incorporated by reference herein:
(a) OXiGENE's Annual Report on Form 10-K, as amended, for the year ended
December 31, 1995;
(b) OXiGENE's Quarterly Report on Form 10-Q for the quarter ended March 31,
1996;
(c) OXiGENE's Quarterly Report on Form 10-Q for the quarter ended June 30,
1996;
(d) OXiGENE's Quarterly Report on Form 10-Q for the quarter ended September
30, 1996; and
(e) The description of the Common Stock contained in OXiGENE's Registration
Statement under the Exchange Act on Form 8-A, as declared effective
August 25, 1993.
All documents filed by OXiGENE pursuant to Sections 13(a), 13(c), 14 or
15(d) of the Exchange Act after the date hereof shall be deemed to be
incorporated herein by reference and to be a part hereof from the date of
filing of such documents. All information appearing in this Prospectus or in
any document incorporated herein by reference is not necessarily complete and
is qualified in its entirety by the information and financial statements
(including notes thereto) appearing in the documents incorporated by reference
herein and should be read together with such information and documents.
Any statement contained in a document incorporated or deemed to be
incorporated herein by reference shall be deemed to be modified or superseded
for purposes of this Prospectus to the extent that a statement contained herein
or in any other subsequently filed document that is deemed to be incorporated
herein by reference modifies or supersedes such statement. Any such statement
so modified or superseded shall not be deemed, except as so modified or
superseded, to constitute a part of this Prospectus.
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411551.6
<PAGE>
THE COMPANY
OXiGENE, Inc. ("OXiGENE" or the "Company") is engaged in the research
and development of products designed to enhance the clinical efficacy of
radiation and chemotherapy, the most common and traditional forms of
non-surgical cancer treatment. The Company's proprietary technology involves
the inhibition, measurement and stimulation of the cellular DNA repair process.
When administered in accordance with their prescribed regimens, the Company
believes that its principal products, Sensamide(TM) and Neu-Sensamide(TM),
should make cancerous tumor cells more sensitive to radiation by inhibiting DNA
repair activity, consequently increasing tumor damage from radiation therapy in
those cells. Accordingly, the Company expects that patient response to
radiation should be improved and result in increased tumor shrinkage, or
reduced side effects, or both.
As of October 14, 1996, approximately 185 patients had been recruited
in a 226-patient European, randomized, controlled Phase II/III clinical trial
of Sensamide(TM) in combination with radiation therapy in patients with
inoperable non-small cell lung cancer. An Investigational New Drug ("IND")
application with respect to this trial was filed with the U.S. Food and Drug
Administration ("FDA") in 1992. At the current patient recruitment rate, the
Company expects to have results of this study available in the third quarter of
1997. In the fourth quarter of 1996, OXiGENE anticipates commencing an
additional 226-patient European, randomized, controlled Phase III clinical
trial in patients with non-small cell lung cancer using Neu-Sensamide(TM), the
Company's reformulated version of Sensamide(TM). Based on preliminary
preclinical studies and a Phase I clinical trial, the Company believes that
Neu-Sensamide(TM) is as effective a radiation sensitizer as Sensamide(TM) is,
with fewer side effects. The combined results of the Sensamide(TM) and
Neu-Sensamide(TM) studies are intended to serve as the basis of the Company's
New Drug Application ("NDA") for Neu-Sensamide(TM) as a radiation sensitizer
for the treatment of patients with non-small cell lung cancer. In March 1996,
the Company filed an additional protocol under its existing IND application
with the FDA to commence a 15-patient, open-label, European Phase I/II study of
Neu-Sensamide(TM) in patients with glioblastomas, a highly malignant form of
brain cancer. As of October 14, 1996, 2 patients had been recruited in this
study. The FDA has indicated in a meeting with the Company that if the Company
is able to demonstrate the clinical efficacy of Neu-Sensamide(TM) in
conjunction with radiation therapy in two different forms of cancer under
controlled study conditions, and in two or three additional forms of cancer
under uncontrolled study conditions, OXiGENE may receive product approval for
Neu-Sensamide(TM) as a radiation sensitizer for all cancer indications treated
with radiation. Typically, uncontrolled studies are of shorter duration because
fewer patients have to be recruited and patient inclusion criteria are less
stringent.
OXiGENE has been testing Oxi-104, a new chemical compound, in its
laboratories for effectiveness, toxicity and other effects. Although classified
as an N-substituted benzamide, Oxi-104, unlike Sensamide(TM) and
Neu-Sensamide(TM), is not based on the N-substituted benzamide known as
metoclopramide. Oxi-104 has been designed with a molecular structure that, the
Company believes, may reduce side effects while maintaining the sensitizing
properties of other N-substituted benzamides. The Company currently anticipates
commencing a Phase I clinical test of Oxi-104 after the intended filing of an
IND with the FDA in the second quarter of 1997. Based on preliminary results,
OXiGENE believes that Oxi-104 alone may induce tumor growth-inhibiting and
tumor-killing effects.
The Company's goal is to develop products that enhance the efficacy of
existing forms of cancer treatment, such as radiation and chemotherapy, and
improve a patient's quality of life, by reducing side effects and inhibiting
the DNA repair function of, and increasing DNA damage in, tumor cells that have
been subjected to treatment. The Company intends to continue and expand its
ongoing clinical trial
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411551.6
<PAGE>
program in Europe and commence research and clinical trials in the United
States. The Company does not own or lease any laboratories or other research
and development facilities. The Company's policy has been to establish
relationships with universities, research organizations and other institutions
in the field of oncology. The Company intends to further broaden these
relationships, rather than expand its in-house research, development and
clinical staff. Although the Company plans to market its products, if and when
approved for marketing, directly in certain European countries, it has had
preliminary discussions with unaffiliated pharmaceutical companies regarding
the formation of possible strategic alliances or joint ventures for the
manufacturing and marketing of its products in the United States, the Far East
and elsewhere. To date, the Company has not entered into any such alliances or
ventures.
The Company's proprietary technology is based on its knowledge of the
processes by which certain enzymes repair damaged DNA sites, a function
essential to a cell's survival. The cell's enzymes that normally repair DNA
damage to the tumor cell counter the cytotoxic (cell-killing) effects of
radiation therapy and chemotherapy by repairing the tumor cell's DNA that has
been damaged by either of those therapies. Specifically, the Company utilizes
its knowledge of how the DNA repair enzyme Adenosine Diphosphate Ribosyl
Transferase ("ADPRT") functions in connection with radiation and chemotherapy
on cancerous cells. Sensamide(TM) is a high-dosage form of metoclopramide.
Metoclopramide is a compound, used for more than 30 years for other clinical
indications, that inhibits ADPRT-modulated DNA repair. Neu-Sensamide(TM) is a
conformationally altered form of Sensamide(TM).
The Company has also developed proprietary assays (tests) that measure
levels of ADPRT in blood, thereby suggesting DNA repair activity that the
Company believes correlates to immune function and status, and has identified a
mixture of compounds that it believes may be capable of stimulating DNA repair.
Based on preclinical studies to date, OXiGENE is now planning the clinical
development of these product areas.
There can be no assurance that the Company's existing and planned
product development efforts and clinical trials for
Sensamide(TM)/Neu-Sensamide(TM), or any other compounds, will be successful or
completed within anticipated time frames, or at all; that regulatory approvals
will be obtained or will be as broad as sought; or that any products, if
introduced, will achieve market acceptance. In addition, there can be no
assurance that the Company's technology will prove effective, that the Company
will be able to enter into strategic alliances or joint ventures or that the
terms thereof will be favorable to the Company, or that the Company will be
profitable.
On October 30, 1996, the Company announced that its Registration
Statement under the Securities Act, covering a proposed public offering by the
Company of 1 million shares of common stock, of which 800,000 shares of common
stock are to be offered in Sweden and other countries outside of the United
States (the "International Offering") and 200,000 shares of common stock are to
be offered in the United States (the "U.S. Offering" and together with the
International Offering, the "Offering"), had been declared effective by the
United States Securities and Exchange Commission. The Offering closed in
mid-November 1996, and net proceeds to the Company were approximately $27.5
million. D. Carnegie AB, a Swedish investment bank, and Nordberg Capital Inc.,
underwrote the Offering.
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411551.6
<PAGE>
The Company was incorporated in New York in 1988, and subsequently was
re-incorporated in Delaware in 1992. The Company established a Swedish
subsidiary, OXiGENE (Europe) AB, in December 1994. The Company's principal
executive office is located at 110 East 59th Street, New York, New York 10022
(telephone number: 212-421-0001; fax number: 212-421-0475), and in Sweden at
Arsenalsgatan 6, S-111 47 Stockholm, Sweden (telephone number: 08-678 8720; fax
number: 08-678 8605) and Scheelevagen 17, S-223 70 Lund, Sweden (telephone
number: 046-16 88 60; fax number: 046-16 88 66). Any references in this
Prospectus to "OXiGENE" or the "Company" shall mean OXiGENE, Inc. and its
wholly-owned Swedish subsidiary OXiGENE (Europe) AB.
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411551.6
<PAGE>
RISK FACTORS
An investment in the shares of Common Stock offered hereby is
speculative, involves a high degree of risk and should only be made by persons
who can afford a loss of their entire investment. In addition to the other
information included elsewhere or incorporated by reference in this Prospectus,
the following risk factors should be considered carefully in evaluating an
investment in the shares of Common Stock offered hereby.
History of Losses and Anticipated Future Financial Results;
Uncertainty of Future Profitability. The Company, as a development stage
enterprise, has experienced net losses every year since its inception and, as
of June 30, 1996, had a deficit accumulated during the development stage of
approximately $14.8 million. The Company anticipates incurring substantial
additional losses over at least the next several years due to, among other
factors, the need to expend substantial amounts on its continuing clinical
trials and anticipated research and development activities and the general and
administrative expenses associated with those activities. The Company has not
commercially introduced any product and its products are in varying stages of
development and testing. The Company's ability to attain profitability will
depend upon its ability to develop products that are effective and commercially
viable, to obtain regulatory approval for the manufacture and sale of its
products and to license or otherwise market its products successfully. There
can be no assurance that the Company will ever achieve profitability or that
profitability, if achieved, can be sustained on an ongoing basis.
Early Stage of Product Development; Uncertainties of Clinical Trials;
Unproven Safety and Efficacy. OXiGENE's products are in an early stage of
development. In order to achieve profitable operations on a continuing basis,
the Company, alone or in collaboration with others, must successfully develop,
manufacture, introduce and market its products. The time frame necessary to
achieve market success for any individual product is long and uncertain. The
products currently under development by the Company will require significant
additional research and development and extensive preclinical and clinical
testing prior to application for commercial use. A number of companies in the
biotechnology and pharmaceutical industries have suffered significant setbacks
in clinical trials, even after showing promising results in earlier studies or
trials. Although the Company has obtained favorable results to date in
preclinical studies and clinical trials of certain of its products, such
results may not be indicative of results that will ultimately be obtained in or
throughout such clinical trials, and there can be no assurance that clinical
testing will show any of the Company's products to be safe or efficacious.
Additionally, there can be no assurance that the Company will not encounter
problems in its clinical trials that will cause the Company to delay, suspend
or terminate those clinical trials. There can also be no assurance that the
Company's research or product development efforts or those of its collaborative
partners will be successfully completed, that any compounds currently under
development by the Company will be successfully developed into drugs, or that
any products will receive regulatory approval on a timely basis, if at all. If
any such problems occur, the Company could be materially and adversely
affected.
Need for Additional Funds; Uncertainty of Future Funding. The
Company's operations to date have consumed substantial amounts of cash.
Negative cash flow from the Company's operations is expected to continue and
even to accelerate over at least the next several years. The Company's capital
requirements will depend on numerous factors, including: the progress of
preclinical testing and clinical trials; the progress of the Company's research
and development programs; the time and costs required to obtain regulatory
approvals; the resources devoted to manufacturing methods and advanced
technologies; the ability to obtain licensing arrangements; the cost of filing,
prosecuting and, if necessary,
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411551.6
<PAGE>
enforcing patent claims; the cost of commercialization activities and
arrangements; and the demand for the Company's products if and when approved.
The Company will have to raise substantial additional funds to complete
development of any product or bring products to market. Issuance of additional
equity securities by the Company, for these or other purposes, could result in
dilution to then existing stockholders, including persons purchasing the Common
Stock. There can be no assurance that additional financing will be available on
acceptable terms, if at all. If adequate funds are not available on acceptable
terms, the Company may be required to delay, scale back or eliminate one or
more of its product development programs or obtain funds through arrangements
with collaborative partners or others that may require the Company to
relinquish rights to certain of its technologies or products that the Company
would not otherwise relinquish, which may have a material adverse effect on the
Company. The Company anticipates that these funding needs will continue despite
the closing of the Offering noted in the "Company" section above.
Dependence on Others for Clinical Development and Manufacturing and
Marketing. The Company has limited experience in drug development, the
regulatory approval process, manufacturing and marketing. Other than Dr. Ronald
W. Pero, Ph.D., the Company's Chief Scientific Officer, and two other
employees, the Company does not directly employ any scientists or other
laboratory personnel and all of its preclinical tests and clinical trials are
subcontracted to and performed at the University of Lund, Sweden and at other
European centers, with the assistance of research and consulting firms.
Accordingly, OXiGENE has depended, and in the future is likely to continue to
depend, on others for assistance in many areas, including research, conducting
preclinical testing and clinical trials, the regulatory approval process,
manufacturing and marketing. Although the Company considers its relations with
existing collaborative partners to be satisfactory, all its current
arrangements are short term in nature. Funding requirements, competitive
factors or prioritization of other opportunities may lead the Company to seek
additional arrangements with third parties. While OXiGENE is likely to explore
license and development opportunities for its technologies with other
companies, there can be no assurance that the Company will be successful in
establishing and maintaining collaborative agreements or licensing
arrangements; that any collaborative partner will not be pursuing alternative
technologies or developing alternative compounds either on its own or in
collaboration with others, directed at the same diseases as those involved in
its collaborative arrangements with the Company; that any such collaborative
partners will devote resources to the Company's technologies or compounds on a
basis favorable to the Company; that any such arrangements will be on terms
favorable to OXiGENE; or that, if established, such future licensees will be
successful in commercializing products. Finally, if the Company's collaboration
arrangements are terminated prior to their expiration or if the other parties
to such arrangements fail to adequately perform, there can be no assurance that
submission of product candidates for regulatory approval will not be delayed.
Clinical Trials; Government Regulation and Health Care Reform; Managed
Care. The Company's research and development activities, preclinical testing
and clinical trials, and the manufacturing and marketing of its products are
subject to extensive regulation by numerous governmental authorities in the
United States and other countries. Preclinical testing and clinical trials and
manufacturing and marketing of OXiGENE's products are and will continue to be
subject to the rigorous testing and approval processes of the U.S. Food and
Drug Administration ("FDA"), the Swedish Medical Products Agency and other
corresponding foreign regulatory authorities. Clinical testing and the
regulatory process generally take many years and require the expenditure of
substantial resources. In addition, delays or rejections may be encountered
during the period of product development, clinical testing and FDA regulatory
review of each submitted application. Similar delays may also be encountered in
foreign countries. There can be no assurance that, even after such time and
expenditures,
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411551.6
<PAGE>
regulatory approval will be obtained for any products developed by OXiGENE or
that a product, if approved in one country, will be approved in other
countries. Moreover, if regulatory approval of a product is granted, such
approval may entail limitations on the indicated uses for which that product
may be marketed. Further, even if such regulatory approval is obtained, a
marketed product, its manufacturer and its manufacturing facilities are subject
to continual review and periodic inspections, and later discovery of previously
unknown problems (such as previously undiscovered side effects) with a product,
manufacturer or facility may result in restrictions on such product,
manufacturer or facility, including a possible withdrawal of the product from
the market. Failure to comply with the applicable regulatory requirements can,
among other things, result in fines, suspensions of regulatory approvals,
product recalls, operating restrictions, injunctions and criminal prosecution.
Additionally, further government regulation may be established which could
prevent or delay regulatory approval of the Company's products. Further, the
U.S. Congress continues to debate various health care reform proposals which,
if adopted, may have a material adverse effect on the Company. Moreover,
continued cost control initiatives by health care maintenance organizations and
similar programs may affect the financial ability and willingness of patients
and their health care providers to utilize certain therapies.
Competition and Risk of Technological Obsolescence. The Company is
engaged in a rapidly evolving field. Competition from other pharmaceutical
companies, biotechnology companies and research and academic institutions is
intense and expected to increase. Many of those companies and institutions have
substantially greater financial, technical and human resources than the
Company. Those companies and institutions also have substantially greater
experience in developing products, in conducting clinical trials, in obtaining
regulatory approval and in manufacturing and marketing pharmaceutical products.
Accordingly, competitors may succeed in obtaining regulatory approval for their
products more rapidly than the Company. The Company also competes with
universities and other research institutions in the development of products,
technologies and processes. Competitors have developed or are in the process of
developing technologies that are, or in the future may be, the basis for
competitive products. Some of those products may have an entirely different
approach or means of accomplishing the desired therapeutic effect than products
being developed by the Company. There can be no assurance that the Company's
competitors will not succeed in developing technologies and products that are
more effective and/or cost competitive than those being developed by the
Company or that would render the Company's technology and products less
competitive or even obsolete. In addition, one or more of the Company's
competitors may achieve product commercialization or patent protection earlier
than the Company, which could materially adversely affect the Company.
Dependence on Patents and Proprietary Technology. To date, OXiGENE's
principal products, Sensamide(TM) and Neu-Sensamide(TM), have been based on
certain available compounds that are produced by others, and its newest
compound, Oxi-104, is a synthetic compound discovered by the Company. The
Company anticipates that products it develops hereafter may include or be based
on the same or other compounds owned or produced by unaffiliated parties, as
well as other synthetic compounds it may discover. Although the Company expects
to seek patent protection for any compounds it discovers and/or for the
specific use of any such compounds, there is no assurance that any or all of
them will 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
the Company believes may continue to be, important to the Company's efforts,
although those processes, as such, may not be patentable.
The Company's success will depend, in part, on its ability to obtain
patents, protect its trade secrets and operate without infringing on the
proprietary rights of others. As of October 18, 1996, the
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<PAGE>
Company is the assignee of four granted U.S. patents, four pending U.S. patent
applications, and of granted patents and/or pending applications in other
countries (and/or international applications designating other countries)
corresponding to three of the granted U.S. patents and two of the pending U.S.
applications. The patent position of pharmaceutical and biotechnology firms
like OXiGENE generally is highly uncertain and involves complex legal and
factual questions, resulting in both an apparent inconsistency regarding the
breadth of claims allowed in U.S. patents and general uncertainty as to their
legal interpretation and enforceability. Accordingly, there can be no assurance
that the Company's patent applications will result in patents being issued,
that any issued patents will provide the Company with competitive protection or
will not be challenged by others, or that the patents of others will not have
an adverse effect on the ability of the Company to do business. Moreover, since
some of the basic research relating to one or more of the Company's patent
applications and/or patents was performed at various universities and/or funded
by grants, particularly in Sweden, there can be no assurance that one or more
universities, employees of such universities and/or grantors will not assert
that they have certain rights in such research and any resulting products,
although the Company is not aware of any such assertions or any basis therefor.
Furthermore, there can be no assurance that others will not independently
develop similar products, will not duplicate any of the Company's products or,
if patents are issued to the Company, will not design around such patents. In
addition, the Company may be required to obtain licenses to patents or other
proprietary rights of others. No assurance can be given that any licenses
required under any such patents or proprietary rights would be made available
on terms acceptable to the Company, if at all. If the Company does not obtain
such licenses, it could encounter delays in product market introductions while
it attempts to design around such patents, or could find that the development,
manufacture or sale of products requiring such licenses is foreclosed. In
addition, the Company could incur substantial costs in defending itself in
suits brought against it or in connection with patents to which it holds a
license or in bringing suit to protect the Company's own patents against
infringement. The Company generally requires employees, Scientific Advisory
Board members and the institutions that perform its preclinical and clinical
tests (though not the employees of such institutions) to enter into
confidentiality agreements with the Company. Those agreements provide that all
confidential information developed or made known to the individual during the
course of the relationship with the Company is to be kept confidential and not
to be disclosed to third parties, except in specific circumstances. In the case
of employees, the agreements also provide that all inventions conceived by such
employees shall be the exclusive property of the Company. There can be no
assurance, however, that any such agreement will provide meaningful protection
for the Company's trade secrets or other confidential information in the event
of unauthorized use or disclosure of such information.
Dependence on Certain Officers and Directors and Others. The Company
believes that its success is, and will likely continue to be, materially
dependent upon its ability to retain the services of certain of its current
officers and directors, particularly Dr. Bjorn Nordenvall, its Chief Executive
Officer, Dr. Claus M0ller, its Chief Medical Officer, and Dr. Ronald Pero, its
Chief Scientific Officer. The loss of the services of any of these individuals
could have a material adverse effect on the Company. In addition, the Company
has established relationships with universities, hospitals and research
institutions, particularly the University of Lund, Lund, Sweden, which have
historically provided, and continue to provide, the Company with access to
research laboratories, clinical trials, facilities and patients. Dr. Pero is a
Professor of Molecular Ecogenetics at the University of Lund. The Company
benefits indirectly from certain research grants received by Dr. Pero. The
Company is materially dependent on the research and development efforts of Dr.
Pero and his various relationships and affiliations, the loss of which could
have a material adverse effect on the Company's business. Additionally, the
Company believes that it may, at any time and from time to time, be materially
dependent on the services of consultants and other unaffiliated third parties.
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411551.6
<PAGE>
Product Liability Exposure; No Insurance Coverage. The use of the
Company's products in clinical trials and for commercial applications, if any,
may expose the Company to liability claims, in the event such products cause
injury, disease or result in adverse effects. These claims could be made
directly by health care institutions, contract laboratories, patients or others
using such products. The Company has no liability insurance coverage for its
ongoing clinical trials, and there can be no assurance that such coverage will
be available at a reasonable cost and in amounts sufficient to protect the
Company against claims or recalls that could have a material adverse effect on
the financial condition and prospects of the Company. Further, adverse product
and similar liability claims could negatively impact the Company's ability to
obtain or maintain regulatory approvals for its technology and products.
Price Volatility of the Common Stock. The market price of the Common
Stock has been, and likely will continue to be, highly volatile as frequently
is the case with the publicly traded securities of pharmaceutical research and
development companies. Factors such as results of clinical trials,
announcements of research developments by the Company or its competitors and
government regulatory action affecting the Company's products in both the
United States and foreign countries may have a significant effect on the
Company's business and on the market price of the Common Stock. As of October
18, 1996, an aggregate of 67,000 stock appreciation rights ("SARs"), with a
weighted average exercise price of $7.09 per SAR, had been granted to certain
clinical investigators and consultants. The Company is not required to make any
cash payments upon exercise of any such SAR. If and when the spread between the
market price of the Company's Common Stock and the exercise price of the SARs
changes, the charge for financial reporting purposes to research and
development will be adjusted to reflect an increase or decrease, as the case
may be, in the market price of the Company's Common Stock. In addition,
substantially all of the shares of Common Stock issuable upon exercise of
outstanding options, SARs and warrants have been registered and may be sold
from time to time hereafter. Such sales, as well as future sales of Common
Stock by existing stockholders, or the perception that sales could occur, could
adversely affect the market price of the Common Stock. The price and liquidity
of the Common Stock may also be significantly affected by trading activity and
market factors related to the Nasdaq and Stockholm Stock Exchange markets,
which factors and effects thereof may differ between those markets.
No Dividends. The Company has not declared or paid dividends on its
Common Stock since its inception and does not intend to declare or pay any
dividends to its stockholders in the foreseeable future.
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411551.6
<PAGE>
SELLING SECURITY HOLDERS
The following table sets forth certain information with respect to the
Selling Securityholders. Except as indicated below, all of the shares of Common
Stock beneficially owned by each Selling Securityholder are being registered
for the account of such Selling Securityholder. Since the Selling
Securityholders may sell all or only some of their shares of Common Stock, no
estimate can be made of the aggregate number or amount of shares of Common
Stock which would be owned by each Selling Securityholder upon completion of
the offering to which this Prospectus relates.
NUMBER OF SHARES NUMBER OF
OF COMMON STOCK SHARES OF
BENEFICIALLY COMMON STOCK
NAME OWNED(1) OFFERED
Stephanie Phillips 147,610 134,400
Jessy W. Dirks 78,400 78,400
Robert Schneider 67,200 67,200
Michael M. LeConey 56,000 56,000
Univest Management, Inc. 50,000 50,000
- ----------------------------
(1) Includes shares purchasable under options and warrants that are
presently exercisable or exercisable within 60 days of the date of
this table (However, there is no obligation with respect to such
options and warrants that they must be exercised within such 60-day
period): Ms. Phillips - 137,610; Ms. Dirks - 78,400; Mr. Schneider -
67,200; Mr. LeConey - 56,000; and Univest Management, Inc. - 50,000.
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<PAGE>
PLAN OF DISTRIBUTION
The shares of Common Stock offered hereby may be offered for resale by
the Selling Securityholders from time to time in transactions for their own
account (which may include block transactions) in the over-the-counter market,
in negotiated transactions, through the writing of options on the shares, or a
combination of such methods of sale, at fixed prices (which may be changed), at
market prices prevailing at the time of sale, at prices related to such
prevailing market prices or at negotiated prices. The Selling Securityholders
may effect such transactions by selling the shares of Common Stock to or
through broker-dealers, and such broker-dealers may receive compensation in the
form of discounts, concessions or commissions from the Selling Securityholders
and/or the purchasers of shares for whom such broker-dealers may act as agent
or to whom they sell as principal, or both (which compensation as to a
particular broker-dealer might be in excess of customary commissions). The
Selling Securityholders and any dealers or agents participating in the
distribution of the Common Stock may be deemed to be "underwriters" as defined
in the Securities Act and any profit on the sale of the Common Stock by them
and any discounts, commissions or concessions received by any such dealers or
agents might be deemed to be underwriting discounts and commissions under the
Securities Act. The Company will not receive any proceeds of the sales of the
Common Stock by the Selling Securityholders.
It is not possible at the present time to determine the price to the
public in any sale of the Common Stock by Selling Securityholders. Accordingly,
the public offering price and the amount of any applicable underwriting
discounts and commissions will be determined at the time of such sale by
Selling Securityholders. The aggregate proceeds to the Selling Securityholders
from the sale of the Common Stock will be the purchase price of the Common
Stock sold less all applicable commissions and underwriters' discounts, if any.
The Company will pay substantially all the expenses incident to the
registration, offering and sale of the Common Stock to the public by Selling
Securityholders.
LEGAL MATTERS
The validity of the shares of Common Stock being offered hereby has
been passed upon by Battle Fowler LLP, New York, New York, a limited liability
partnership including professional corporations.
EXPERTS
The consolidated financial statements of the Company appearing in the
Company's Annual Report (Form 10-K, as amended) for the year ended December 31,
1995, have been audited by Ernst & Young LLP, independent auditors, as set
forth in their report thereon and incorporated herein by reference. Such
financial statements are incorporated herein by reference in reliance upon such
report given upon the authority of such firm as experts in accounting and
auditing.
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411551.6
<PAGE>
---------------------------
No dealer, salesman or any other person is authorized to give
any information or to make any representations other than those contained or
incorporated by reference in this Prospectus, and if given or made, such
information or representations should not be relied upon as having been
authorized. This Prospectus does not constitute an offer to sell, or a
solicitation of an offer to buy the shares of Common Stock offered by this
Prospectus, by anyone in any jurisdiction in which such offer to sell or
solicitation is not authorized, or in which the person making such offer is not
qualified to do so or to any person to whom it is unlawful to make such offer
or solicitation. Neither the delivery of the Prospectus nor any distribution of
shares pursuant to this Prospectus shall, under any circumstances, create any
implication that there has been no change in the information set forth or
incorporated by reference herein or in the affairs of the Company since the
date of this Prospectus.
--------------------------
PAGE
AVAILABLE INFORMATION......................................................-2-
INCORPORATION BY REFERENCE.................................................-3-
THE COMPANY................................................................-4-
RISK FACTORS...............................................................-7-
SELLING SECURITY HOLDERS..................................................-12-
PLAN OF DISTRIBUTION......................................................-13-
LEGAL MATTERS.............................................................-13-
EXPERTS...................................................................-13-
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<PAGE>
PART II
Item 14. Other Expenses of Issuance and Distribution.
The fees and expenses payable by the Company in connection
with the issuance and distribution of the shares of Common Stock being
registered are estimated as follows:
Amount
SEC Filing Fee............................. $ 2,895
Legal Fees and Expenses*................... 10,000
Accounting Fees*........................... 2,000
Printing Expenses*......................... 500
Total................................... $15,395
=======
- --------------------
* Indicates estimate
Item 15. Indemnification of Directors and Officers.
The Company is a Delaware corporation. Reference is made to Section 145
of the Delaware General Corporation Law (the "DGCL"), which provides that a
corporation may indemnify any person who was or is a party or is threatened to
be made a party to any threatened, pending or completed legal action, suit or
proceeding, whether civil, criminal, administrative or investigative (other
than an action by or in the right of such corporation), by reason of the fact
that such person is or was an officer, director, employee or agent of such
corporation, or is or was serving at the request of such corporation as an
officer, director, employee or agent of another corporation, partnership, joint
venture, trust or other enterprise. The indemnity may include expenses
(including attorneys' fees), judgments, fines and amounts paid in settlement
actually and reasonably incurred by such person in connection with such action,
suit or proceeding, provided such officer, director, employee or agent acted in
good faith and in a manner reasonably believed by such person to be in or not
opposed to the corporation's best interests and, for criminal proceedings, such
person had no reasonable cause to believe that his conduct was unlawful. A
Delaware corporation may indemnify officers and directors in an action by or in
the right of the corporation under the same conditions, except that no
indemnification is permitted in respect of any claim, issue or matter without
judicial approval if the officer or director is adjudged to be liable to the
corporation. Where an officer or director is successful on the merits or
otherwise in the defense of any action referred to above, the corporation must
indemnify such officer or director against the expenses (including attorneys'
fees) that such officer or director actually and reasonably incurred.
Reference is also made to Section 102(b)(7) of the DGCL, which enables a
corporation in its certificate of incorporation to eliminate or limit the
personal liability of a director for monetary damages for violations of the
director's fiduciary duty, except (i) for any breach of the director's duty of
loyalty to the corporation or its stockholders, (ii) for acts or omissions not
in good faith or which involve intentional misconduct or a knowing violation of
law, (iii) pursuant to Section 174 of the DGCL
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<PAGE>
(providing for liability of directors for unlawful payment of dividends or
unlawful stock purchases or redemptions) or (iv) for any transaction from which
a director derived an improper personal benefit.
Article IX, Section 3 of the Company By-laws provides as follows:
"SECTION 3. Indemnification. The Corporation shall, to the fullest extent
permitted by the General Corporation Law of the State of Delaware, indemnify
members of the Board and may, if authorized by the Board, indemnify its
officers, employees and agents and any and all persons whom it shall have power
to indemnify against any and all expenses, liabilities or other matters."
ARTICLE NINTH of the Company's Restated Certificate of Incorporation
provides as follows:
"To the fullest extent permitted by the General Corporation Law of the
State of Delaware, no director of the Corporation shall be personally liable to
the Corporation or its stockholders for monetary damages for breach of
fiduciary duty as a director, except for liability (i) for any breach of the
director's duty of loyalty to the Corporation or its stockholders, (ii) for
acts or omissions not in good faith or that involve intentional misconduct or a
knowing violation of law, (iii) under Section 174 of the General Corporation
Law of the State of Delaware, or (iv) for any transaction from which the
director derived an improper personal benefit. Any repeal or modification of
this Article Ninth by the stockholders of the Corporation shall not adversely
affect any right or protection of a director of the Corporation existing at the
time of such repeal or modification with respect to acts or omissions occurring
prior to such repeal or modification."
Insofar as indemnification for liabilities arising under the Securities
Act may be permitted to directors, officers or persons controlling the Company
pursuant to the foregoing provisions, the Company has been informed that in the
opinion of the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Securities Act and is therefore
unenforceable.
Following the 1996 Annual Meeting of Stockholders, the Company entered
into indemnification agreements with each of its directors and executive
officers.
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411551.6
<PAGE>
Item 16. Exhibits.
5* Legal Opinion of Battle Fowler LLP
23.1 Consent of Ernst & Young LLP, New York, New York
23.2* Consent of Battle Fowler LLP (included in Exhibit 5)
24.1* Power of Attorney (included herein on the signature page)
- ------------
* Previously filed.
Item 17. Undertakings.
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
(ii) To reflect in the Prospectus any facts or events arising after
the effective date of this registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set forth
in this registration statement;
(iii) To include any material information with respect to the plan of
distribution not previously disclosed in this registration statement
or any material change to such information in this registration
statement;
Provided, however, that paragraphs (1)(i) and (1)(ii) do not apply if the
information required to be included in a post-effective amendment by those
paragraphs is contained in periodic reports filed by the Registrant pursuant to
Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are
incorporated by reference in this registration statement.
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be deemed to
be a new registration statement relating to the securities offered therein, and
the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof; and
(3) To remove from registration by means of a post-effective amendment
any of the securities which remain unsold at the termination of the offering.
The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
Registrant's annual report pursuant to section 13(a) or section 15(d) of the
Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to section 15(d) of the
Securities Exchange Act of 1934) that is
II-3
411551.6
<PAGE>
incorporated by reference in this Registration Statement shall be deemed to be
a new registration statement relating to the securities offered therein, and
the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to directors, officers and controlling persons of
the Registrant pursuant to the provisions described above in Item 15, the
Registrant has been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the
Securities Act of 1933 and is, therefore, unenforceable. In the event that a
claim for indemnification against such liabilities (other than the payment by
the Registrant of expenses incurred or paid by a director, officer or
controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person
in connection with the securities being registered, the Registrant will, unless
in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question of
whether such indemnification by it is against public policy as expressed in the
Securities Act of 1933 and will be governed by the final adjudication of such
issue.
The undersigned Registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities Act of
1933, the information omitted from the form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in a form of
prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h)
under the Securities Act of 1933 shall be deemed to be part of this
registration statement as of the time it was declared effective.
(2) For the purpose of determining any liability under the Securities Act
of 1933, each post-effective amendment that contains a form of prospectus shall
be deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
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411551.6
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
registrant certifies that it has reasonable grounds to believe that it meets
all of the requirements for filing on Form S-3 and has duly caused this
Amendment No. 1 to the Registration Statement to be signed on its behalf by the
undersigned, thereunto duly authorized in the City of New York, State of New
York, on November 18, 1996.
OXiGENE, INC.
By /s/ Bjorn Nordenvall
Bjorn Nordenvall
Chairman of the Board
Pursuant to the requirements of the Securities Act of 1933, this
registration statement has been signed by the following persons in the
capacities and on the dates indicated.
<TABLE>
<CAPTION>
Signature Title Date
<S> <C> <C>
/s/ Bjorn Nordenvall President, Chief Executive November 18, 1996
- ----------------------------------------------- Officer and Chairman of the
Bjorn Nordenvall Board of Directors (Principal
Executive Officer)
/s/ Bo Haglund Chief Financial Officer November 18, 1996
- ----------------------------------------------- (Principal Financial Officer and
Bo Haglund Principal Accounting Officer)
* Director November 18, 1996
- -----------------------------------------------
* Director November 18, 1996
- -----------------------------------------------
Chief Medical Officer and November __, 1996
- ----------------------------------------------- Director
Claus Moller
Chief Scientific Officer and November __, 1996
- ----------------------------------------------- Director
Ronald Pero
</TABLE>
* By: /s/ Bo Haglund
-----------------------
as Attorney-in-fact
<PAGE>
EXHIBIT INDEX
Sequential
Exhibit Page
Number Description Number
5* -Legal Opinion of Battle Fowler LLP
23.1 -Consent of Ernst & Young LLP, New York, New York
23.2* -Consent of Battle Fowler LLP (included in Exhibit 5)
24.1* -Power of Attorney (included herein on the signature page)
- -----------
* Previously filed.
Consent of Independent Auditors
We consent to the reference to our firm under the caption "Experts" in the
Registration Statement (Form S-3 No. 333-15241) and related Prospectus of
OXiGENE, Inc. for the registration of 386,000 shares of its common stock and to
the incorporation by reference therein of our report dated February 27, 1996,
with respect to the consolidated financial statements of OXiGENE, Inc. included
in its Annual Report (Form 10-K, as amended) for the year ended December 31,
1995, filed with the Securities and Exchange Commission.
/S/ ERNST & YOUNG LLP
ERNST & YOUNG LLP
New York, New York
November 15, 1996
