As filed with the Securities and Exchange Commission on October 24, 1996
Registration No. 333-12867
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)
Copies to:
GERALD A. EPPNER, ESQ. DENNIS N. BERMAN, ESQ. PETER BAARNHIELM, ADV.
BATTLE FOWLER LLP SONNENSCHEIN NATH & DANOWSKY & PARTNERS
Park Avenue Tower ROSENTHAL ADVOKATBYRA
75 East 55th Street 1221 Avenue of the Americas Hovslagargatan 5
New York, New York 10022 New York, New York 10020 S-103 22 Stockholm
(212) 856-7000 (212) 768-6700 Sweden
46-8 614 6400
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.
/ /
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. / /
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 this Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
<PAGE>
<TABLE>
OXiGENE, INC.
-------------------------
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
<CAPTION>
Item
No. Form S-3 Caption Prospectus Page or Caption
- ----- ----------------- --------------------------
<C> <C> <C>
1. Forepart of Registration Statement and Outside Front
Cover Page of Prospectus....................... Facing Page of Registration Statement; 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; Prospectus Summary; Risk
Factors; Management's Discussion and
Analysis of Financial Condition and Results of
Operations; Selected Financial Data
4. Use of Proceeds...................................... Use of Proceeds
5. Determination of Offering Price...................... Underwriting
6. Dilution............................................. Dilution
7. Selling Security Holders............................. N/A
8. Plan of Distribution................................. Outside Front Cover Page of Prospectus;
Underwriting
9. Description of Securities to be Registered........... Description of Securities
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>
<PAGE>
Information contained herein is subject to completion or amendment. A
registration statement relating to these securities has been filed with the
Securities and Exchange Commission. These securities may not be sold nor may
offers to buy be accepted prior to the time the registration statement becomes
effective. This prospectus shall not constitute an offer to sell or the
solicitation of an offer to buy nor shall there be any sale of these securities
in any State in which such offer, solicitation or sale would be unlawful prior
to registration or qualification under the securities law of any such state.
PROSPECTUS (Subject to Completion)
Dated October 23, 1996
1,000,000 Shares
Common Stock
($.01 par value)
OXiGENE, INC.
Of the 1,000,000 shares of Common Stock ("Shares") of OXiGENE, Inc.
("Company") offered by the Company hereby, 800,000 Shares are being offered in
Sweden and other countries outside the United States (the "International
Offering") and 200,000 Shares are being offered in the United States (the "U.S.
Offering" and together with the International Offering, the "Offering"). The
number of Shares offered in the International and the U.S. Offerings shown
above are indicative amounts only. The number of Shares actually sold in each
Offering may be more or less than such amounts.
The Company's Common Stock is traded on the Nasdaq SmallCap Market
under the symbol "OXGN." On October 18, 1996, the closing price of the Common
Stock on that market was $25.75 per share. See "Market Data." The Company
expects that the Common Stock will be listed for trading on the Nasdaq National
Market and on the Stockholm Stock Exchange immediately following the closing of
this Offering.
-----------------------------------------------------
See "Risk Factors" Commencing on Page 9 For A Discussion of Certain Factors
That Should Be Considered By Prospective Investors.
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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.
-----------------------------------------------------
===========================================================================
Underwriting Discounts
Price to and Proceeds to the
Public Commissions(1) Company(2)
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Per Share $ $ $
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Total(3) $ $ $
==========================================================================
(1) The Company has agreed to indemnify the Underwriters against certain
liabilities, including liabilities under the Securities Act of 1933, as
amended. See "Underwriting."
(2) Before deducting offering expenses estimated to be $450,000, payable by
the Company.
(3) The Company has granted to the Underwriters a 30-day option to purchase
up to 150,000 additional shares of Common Stock solely to cover
over-allotments, if any, on the same terms and conditions as the Shares
offered hereby. If such option is exercised in full, the total Price to
Public, Underwriting Discounts and Commissions and Proceeds to the
Company will be $___________, $___________ and $______________,
respectively. See "Underwriting."
-----------------------------------------------------
The Shares are offered by the several Underwriters, as specified
herein, subject to receipt and acceptance by them and subject to their right to
reject any order in whole or in part. It is expected that the Shares will be
ready for delivery in book-entry form on or about , 1996.
D. CARNEGIE AB
NORDBERG CAPITAL INC.
<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 being
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 as to the contents of any contract or other
document referred to herein are not necessarily complete, and in each instance
reference is made to the copy of such contract or other document filed or
incorporated by reference as an exhibit to the Registration Statement or
incorporated by reference therein, each such statement being qualified in all
respects by such reference.
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;
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400608.11
<PAGE>
(c) OXiGENE's Quarterly Report on Form 10-Q for the quarter ended June 30,
1996; and
(d) 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.
------------------------------------------------------
Information set forth on the cover page and under the captions "Use of
Proceeds" and "Underwriting" are set forth in U.S. dollars, based on the
exchange rate of $1.00 to Swedish Kronor ("SEK") .1502 as published by The Wall
Street Journal on Friday, October 18, 1996.
------------------------------------------------------
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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400608.11
<PAGE>
IN CONNECTION WITH THIS OFFERING, THE UNDERWRITERS MAY OVER-ALLOT OR
EFFECT TRANSACTIONS WHICH STABILIZE OR MAINTAIN THE MARKET PRICE OF THE COMMON
STOCK AT A LEVEL ABOVE THAT WHICH MIGHT OTHERWISE PREVAIL IN THE OPEN MARKET.
SUCH TRANSACTIONS MAY BE EFFECTED ON THE NASDAQ NATIONAL MARKET, IN THE
OVER-THE-COUNTER MARKET OR OTHERWISE. SUCH STABILIZING, IF COMMENCED, MAY BE
DISCONTINUED AT ANY TIME.
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400608.11
<PAGE>
PROSPECTUS SUMMARY
The following summary is qualified in its entirety by the more detailed
information and financial statements and notes thereto appearing elsewhere in
this Prospectus. The Shares offered hereby involve a high degree of risk. See
"Risk Factors." Unless otherwise indicated, all information contained in this
Prospectus assumes that the Underwriters' over-allotment option will not be
exercised. Certain terms are defined in the Glossary beginning on page 55 of
this Prospectus.
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
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<PAGE>
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 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.
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:
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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.
The Offering
Securities offered.................... 1,000,000 shares of Common Stock.
See "Description of Securities."
Common Stock to be outstanding
after the Offering.................... 8,655,978 shares (1)
Use of proceeds....................... To finance clinical trials and research
and development activities, including
acquisitions of related capital
equipment, and for working capital and
general corporate purposes.
See "Use of Proceeds."
Risk factors.......................... Investment in the Shares offered
hereby involves a high degree of risk.
See "Risk Factors."
Nasdaq and SSE symbols (2): ......... OXGN
- -------------------
(1) Excludes, as of October 18, 1996, an aggregate of 3,967,260 shares of
Common Stock reserved for issuance, consisting of (i) 1,279,500 shares
of Common Stock issuable upon exercise of outstanding options at a
weighted average exercise price of approximately $12.24 per share, (ii)
48,553 shares of Common Stock issuable upon exercise of outstanding
stock appreciation rights ("SARs") (based on the closing price of the
Common Stock on October 18, 1996 of $25.75), (iii) 1,268,207 shares of
Common Stock issuable upon exercise of outstanding Public Warrants (as
defined under "Market Data") at a current exercise price of $12.35 per
Public Warrant, (iv) 336,000 shares of Common Stock issuable upon
exercise of warrants held by persons affiliated with the representative
of the underwriters of the Company's initial public offering at a
weighted average exercise price of $12.44 per share, (v) 370,000 shares
of Common Stock issuable upon exercise of other warrants at a weighted
average exercise price of $2.15 per share, and (vi) 665,000 shares of
Common Stock reserved and remaining available for issuance under the
Company's 1996 Stock Incentive Plan. See "Capitalization,"
"Management--1996 Stock Incentive Plan," "Description of
Securities--Public Warrants" and Note 3 of the Notes to the Financial
Statements.
(2) The Company has made application to The Nasdaq Stock Market ("Nasdaq")
to have its shares of Common Stock included in the Nasdaq National
Market upon completion of this Offering. In addition, the Company has
made application to the Stockholm Stock Exchange ("SSE") to have its
shares of Common Stock listed on the SSE upon completion of this
Offering.
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<TABLE>
Summary of Selected Financial Information
OXiGENE, Inc.
(A development stage company)
<CAPTION>
Years Ended December 31,
------------------------
1991 1992 1993 1994 1995
---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C>
Statement of Operations Data:
Revenues:
Research income.................. $ 17,500 $ 0 $ 0 $ 0 $ 0
Interest income.................. 0 0 50,897 265,440 420,949
--------- ----------- --------- --------- --------
Total revenues................. 17,500 0 50,897 265,440 420,949
Operating expenses:
Research and development......... 284,032 910,937 879,195 1,764,462 2,843,593
General and administrative....... 235,340 717,730 1,191,714 1,340,737 1,295,191
------- --------- --------- --------- ---------
Total operating expenses....... 519,372 1,628,667 2,070,909 3,105,199 4,138,784
------- --------- --------- --------- ---------
Net loss........................... $ (501,872) $ (1,628,667) $ (2,020,012) $ (2,839,759) $ (3,717,835)
======= ========= ========= ========= =========
Net loss per
common share(1).................. $ (0.16) $ (0.45) $ (0.50) $ (0.56) $ (0.63)
</TABLE>
<TABLE>
<CAPTION>
Six Months Ended June 30,
-------------------------
1995 1996
---- ----
<S> <C> <C>
Statement of Operations Data:
Revenues:
Research income.................. $ 0 $ 0
Interest income.................. 82,224 253,699
--------- ---------
Total revenues................. 82,224 253,699
Operating expenses:
Research and development......... 1,273,221 2,356,395
General and administrative....... 645,824 1,309,029
------- ---------
Total operating expenses....... 1,919,045 3,665,424
--------- ---------
Net loss........................... $ (1,836,821) $ (3,411,725)
========= =========
Net loss per
common share(1).................. $ (0.36) $ (0.49)
</TABLE>
<TABLE>
<CAPTION>
December 31,
------------
1991 1992 1993 1994 1995
---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C>
Balance Sheet Data:
Cash and cash equivalents........... $ 416,149 $ 164,648 $7,516,941 $1,193,999 $10,406,605
Securities available for sale(2).... 0 0 0 3,291,128 502,020
Working capital..................... 218,132 29,031 7,207,265 4,447,080 10,510,024
Deficit accumulated during the
development stage................... (1,193,601) (2,822,268) (4,842,280) (7,682,039) (11,399,874)
Total stockholders' equity.......... 218,732 29,031 7,240,866 4,479,982 10,557,174
</TABLE>
<TABLE>
<CAPTION>
June 30, 1996
-------------
As
Actual Adjusted(3)
------ --------
<S> <C> <C>
Balance Sheet Data:
Cash and cash equivalents........... $10,709,940 $34,722,440
Securities available for sale(2).... 0 0
Working capital..................... 10,065,731 34,078,231
Deficit accumulated during the
development stage................... (14,811,599) (14,811,599)
Total stockholders' equity.......... 10,117,167 34,129,667
</TABLE>
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(1) See Note 1 of the Notes to the Financial Statements for information
concerning the computation of net loss per common share.
(2) See Note 2 of the Notes to the Financial Statements.
(3) Adjusted to reflect the sale by the Company of the 1,000,000 Shares at
an assumed offering price of $25.75 per Share, the closing price of the
Company's Common Stock on October 18, 1996 (after deducting
underwriting discounts and commissions and estimated offering
expenses), and the application of the estimated net proceeds therefrom.
See "Use of Proceeds" and "Capitalization".
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RISK FACTORS
An investment in the Shares 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.
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. See "Management's Discussion and Analysis
of Financial Condition and Results of Operations."
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. See
"Business--Product Development and Regulatory Processes." 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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<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. See "Use of Proceeds."
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 Shares. 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.
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. See
"Dependence on Certain Officers and Directors and Others." 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.
See "Business--Research and Development and Collaborative Arrangements."
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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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. See "Business - Product Development and Regulatory Processes."
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. See "Business--Competition." 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.
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<PAGE>
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 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. See "Business--Patents
and Trade Secrets."
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 Moller, 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
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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.
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. See "Market Data." 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 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. See "Management's Discussion and Analysis
of Financial Condition and Results of Operations." 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 Company has agreed, for a period of
90 days after the date of this Prospectus, and its officers and directors,
holding an aggregate of 646,500 shares of Common Stock and options and other
rights to purchase up to 870,000 additional shares of Common Stock have agreed,
for a period of 180 days after the date of this Prospectus, that they will not,
directly or indirectly, offer, sell, offer to sell, contract to sell, pledge,
grant any option to purchase or otherwise sell or dispose (or announce any
offer, sale, offer of sale, contract of sale, pledge, grant of any option to
purchase or other sale or disposition) of any shares of Common Stock or other
capital stock of the Company, or any securities convertible into, or
exercisable or exchangeable for, any shares of Common Stock or other capital
stock of the Company (subject, in the case of the Company, to certain limited
exceptions), without the prior written consent of D. Carnegie AB, on behalf of
the Underwriters. See "Underwriting." The price and liquidity of the Shares may
also be significantly affected by trading activity and market factors related
to the Nasdaq and SSE markets, which factors and the 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. See "Dividend Policy"
and "Management's Discussion and Analysis of Financial Condition and Results of
Operations."
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Dilution. Upon completion of this Offering, purchasers of the Shares
will incur immediate and substantial dilution of $21.62 in the per share net
tangible book value of their Common Stock from the assumed public offering
price. See "Dilution."
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MARKET DATA
On August 26, 1993, the Company completed an initial public offering of
1,605,000 units, each unit consisting of one share of the Company's common
stock, par value $.01 per share ("Common Stock"), and a warrant ("Public
Warrant") which is currently exercisable for 1.07 shares of Common Stock. See
"Description of Securities." The Common Stock and Public Warrants are listed
for quotation under the symbols "OXGN" and "OXGNW," respectively, on the Nasdaq
SmallCap Market. Application has been made to list the Common Stock and Public
Warrants on the Nasdaq National Market, to be effective upon completion of this
Offering. In addition, application has been made to list the Common Stock on
the SSE. The following table sets forth the high and low per share and per
warrant bid prices for the Common Stock and Public Warrants, respectively, for
each quarterly period within the Company's two most recent fiscal years and for
the current fiscal year through October 18, 1996.
Common Stock Public Warrants
------------ ---------------
Fiscal Year High Low High Low
- ----------- ---- --- ---- ---
1994
First Quarter $7.50 $5.75 $3.38 $2.13
Second Quarter 10.50 5.50 4.75 2.00
Third Quarter 10.25 5.50 4.75 2.00
Fourth Quarter 7.88 4.63 1.88 .88
1995
First Quarter $7.25 $4.63 $2.00 $1.00
Second Quarter 7.38 5.13 2.13 1.44
Third Quarter 7.75 6.38 2.63 1.75
Fourth Quarter 11.75 5.75 3.63 1.75
1996
First Quarter $23.13 $9.25 $15.00 $2.88
Second Quarter 32.13 17.50 23.50 10.25
Third Quarter 27.00 16.75 17.75 8.50
Fourth Quarter (through October 18, 26.00 22.00 15.25 10.75
1996)
On October 18, 1996, the high and low per share and per warrant bid
prices for the Common Stock and Public Warrants were $26.00, and $25.25, and
$15.25, and $14.50, respectively.
As of October 18, 1996, there were 59 holders of record of the
Company's Common Stock and 4 holders of record of the Company's Public
Warrants. The Company believes, based on the number of proxy statements and
related materials distributed in connection with its 1996 Annual Meeting of
Stockholders, that there are more than 1,250 beneficial owners of its Common
Stock.
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USE OF PROCEEDS
The net proceeds to the Company from the sale of the 1,000,000 Shares
offered hereby (at an assumed public offering price of $25.75 per Share, the
closing price of the Common Stock on October 18, 1996) are estimated to be
$24.0 million (approximately $27.7 million if the Underwriters' over-allotment
option for 150,000 shares of Common Stock is exercised in full), after
deducting the underwriting discounts and commissions and estimated offering
expenses payable by the Company.
The Company currently intends to use the net proceeds as follows: (i)
approximately $17.0 million (or $19.6 million if the Underwriters'
over-allotment option is exercised in full) for funding activities related to
the Company's products that are currently under development, including
providing funds in connection with related ongoing clinical trials, research
and development and capital expenditures, and regulatory applications and costs
associated with the sale and marketing of those products, if approved; (ii)
approximately $3.5 million (or $4.0 million if the Underwriters' over-allotment
option is exercised in full) for research, development and related capital
expenditures, including equipment, in connection with additional potential
products and uses for the Company's technology; and (iii) the balance for
working capital and general corporate purposes.
The foregoing represents the Company's best estimate of its allocation
of the net proceeds from the sale of 1,000,000 Shares based upon the current
state of its business operations, its current plans and current economic and
industry conditions and is subject to reallocation among the categories listed
above or to new categories. The amounts and timing of actual expenditures will
depend upon numerous factors, including results of preclinical testing and
clinical trials, results of research and development, relationships with
strategic corporate partners, changes in direction and focus of the Company's
research and development programs, competitive and technological advances, the
United States and foreign regulatory process and other factors. Additionally,
it is the Company's policy regularly to review potential opportunities to
acquire, or to enter into joint venture or licensing relationships with respect
to, products and businesses compatible with its existing business. The Company
may, therefore, use a portion of the net proceeds to make acquisitions or to
fund joint research and development or other complementary ventures or
strategic alliances, although the Company does not currently have any
arrangements, agreements or understandings with respect thereto.
The Company believes that the net proceeds of this Offering, together
with its available cash, cash equivalents, investment securities and investment
income, should be sufficient to finance its cash requirements for a period of
approximately 30 months from the date of this Prospectus. The Company will
require additional funds to finance its business, through borrowings or by
raising additional equity capital, until such time as (i) it can commercially
exploit its technology, either through licensing arrangements or the sale of
products based on its technology, and (ii) revenues from those commercial
activities become sufficient to cover its expenses. As the Company expects that
the capital it has on hand and the net proceeds from this Offering will not be
sufficient to finance its business until such time, the Company anticipates
that it will need to obtain additional financing, the amount and timing of
which is currently uncertain and the availability of which, on terms reasonably
acceptable to the Company, if at all, cannot be assured. See "Risk
Factors--Need for Additional Funds; Uncertainty of Future Funding."
Pending the aforementioned uses, the net proceeds of this Offering will
be invested in U.S. Government securities; short-term, investment grade
securities; customary bank deposits maintained at first class banks in Sweden
or the United States; or other short-term, interest bearing financial
instruments
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that will not cause the Company to become an "investment company" within the
meaning of the U.S. Investment Company Act of 1940.
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CAPITALIZATION
The following table sets forth the capitalization of the Company at
June 30, 1996, and as adjusted at that date to reflect the sale by the Company
of the Shares at an assumed offering price of $25.75 per share, the closing
price of the Common Stock on October 18, 1996 (after deducting underwriting
discounts and commissions and estimated offering expenses) and the receipt of
the estimated net proceeds therefrom, as set forth under the caption "Use of
Proceeds."
<TABLE>
<CAPTION>
June 30, 1996(1)
----------------
(All amounts in thousands)
Actual As Adjusted
------ -----------
<S> <C> <C>
Stockholders' equity:
Common Stock, $.01 par value, 15,000,000 shares authorized, 7,271,282
shares issued and outstanding; 8,271,282 shares
issued and outstanding, as adjusted(2)(3)............................. $ 72 $ 82
Additional paid-in capital................................................. 24,853 48,856
Common Stock subscribed.................................................... 98 98
Subscription receivable.................................................... (98) (98)
Foreign currency translation adjustment.................................... 3 3
Deficit accumulated during the development stage........................... (14,811) (14,811)
-------- ----------
Total stockholders' equity............................................ $ 10,117 $ 34,130
=========== ===========
</TABLE>
(1) At June 30, 1996, the Company did not have any long-term or short-term
debt.
(2) At the 1996 Annual Meeting of Stockholders, the Company's stockholders
approved an amendment to the Company's Amended and Restated Certificate
of Incorporation, increasing the number of authorized shares of Common
Stock from 15 million to 60 million shares.
(3) Excludes, as of October 18, 1996, an aggregate of 3,967,260 shares of
Common Stock reserved for issuance, consisting of (i) 1,279,500 shares
of Common Stock issuable upon exercise of outstanding options at a
weighted average exercise price of approximately $12.24 per share, (ii)
48,553 shares of Common Stock issuable upon exercise of outstanding
SARs (based on the closing price of the Common Stock on October 18,
1996 of $25.75), (iii) 1,268,207 shares of Common Stock issuable upon
exercise of outstanding Public Warrants at a current exercise price of
$12.35 per Public Warrant, (iv) 336,000 shares of Common Stock issuable
upon exercise of warrants held by persons affiliated with the
representative of the underwriters of the Company's initial public
offering at a weighted average exercise price of $12.44 per share, (v)
370,000 shares of Common Stock issuable upon exercise of other warrants
at a weighted average exercise price of $2.15 per share, and (vi)
665,000 shares of Common Stock reserved and remaining available for
issuance under the Company's 1996 Stock Incentive Plan. See
"Management--1996 Stock Incentive Plan," "Description of
Securities--Public Warrants" and Note 3 of the Notes to the Financial
Statements.
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DILUTION
The net tangible book value of the Company at June 30, 1996, was
$10,117,167 or $1.39 per share. Net tangible book value per share is equal to
the Company's total tangible assets less its total liabilities, divided by the
number of shares of Common Stock outstanding. After giving effect to the sale
by the Company of 1,000,000 Shares offered hereby, at an assumed public
offering price of $25.75 (the closing price of the Company's Common Stock on
October 18, 1996) (after deducting underwriting discounts and commissions and
estimated offering expenses), and the receipt of the estimated net proceeds
therefrom, the adjusted net tangible book value of the Company at June 30,
1996, would have been $34,129,667 or $4.13 per share of Common Stock. This
represents an immediate increase in net tangible book value of $2.74 per share
of Common Stock to existing stockholders and an immediate dilution in net
tangible book value of $21.62 per Share to new investors purchasing the Shares.
The following table illustrates this per Share dilution:
Assumed public offering price per Share(1)........................ $25.75
Net tangible book value per share
before the Offering..........................$1.39
Increase per share attributable to
new investors................................$2.74
Adjusted net tangible book value per share after the Offering..... $ 4.13
-----
Dilution per share to new investors............................... $21.62
=====
(1) Excludes, as of October 18, 1996, an aggregate of 3,967,260 shares of
Common Stock reserved for issuance, consisting of (i) 1,279,500 shares of
Common Stock issuable upon exercise of outstanding options at a weighted
average exercise price of approximately $12.24 per share, (ii) 48,553 shares of
Common Stock issuable upon exercise of outstanding SARs (based on the closing
price of the Common Stock on October 18, 1996 of $25.75), (iii) 1,268,207
shares of Common Stock issuable upon exercise of outstanding Public Warrants at
a current exercise price of $12.35 per Public Warrant, (iv) 336,000 shares of
Common Stock issuable upon exercise of warrants held by persons affiliated with
the representative of the underwriters of the Company's initial public offering
at a weighted average exercise price of $12.44 per share, (v) 370,000 shares of
Common Stock issuable upon exercise of other warrants at a weighted average
exercise price of $2.15 per share, and (vi) 665,000 shares of Common Stock
reserved and remaining available for issuance under the Company's 1996 Stock
Incentive Plan. The computations in the foregoing table assume no exercise of
these options, warrants and SARs. To the extent these options, warrants and
SARs are exercised, there will be further dilution to new investors. See
"Capitalization" and Note 3 of the Notes to the Financial Statements.
DIVIDEND POLICY
The Company has not paid any cash dividends since its inception and
does not intend to pay any cash dividends in the foreseeable future. The
Company currently intends to retain future earnings, if any, to finance the
growth and development of its business.
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SELECTED FINANCIAL INFORMATION
The following selected financial information for each of the five years
in the period ended December 31, 1995, has been derived from the Company's
financial statements, which statements have been audited by Ernst & Young LLP,
independent auditors. The following selected financial information for the six
months ended June 30, 1995 and 1996, has been derived from unaudited financial
statements which, in the opinion of management of the Company, reflect all
adjustments, consisting only of normal recurring adjustments, necessary to
present fairly the financial data for such periods. Operating results for the
six months ended June 30, 1996 are not necessarily indicative of the results
that may be expected for the year ending December 31, 1996. All of the
financial information set forth below should be read in conjunction with the
financial statements and notes thereto included elsewhere in this Prospectus
and also with the information appearing under the caption "Management's
Discussion and Analysis of Financial Condition and Results of Operations."
<TABLE>
Summary Financial Information
OXiGENE, Inc.
(A development stage company)
<CAPTION>
Years Ended December 31,
------------------------
1991 1992 1993 1994 1995
---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C>
Statement of Operations Data:
Revenues:
Research income............... $ 17,500 $ 0 $ 0 $ 0 $ 0
Interest income............... 0 0 50,897 265,440 420,949
------- --------- --------- --------- ---------
Total revenues.............. 17,500 0 50,897 265,440 420,949
Operating expenses:
Research and development...... 284,032 910,937 879,195 1,764,462 2,843,593
General and administrative.... 235,340 717,730 1,191,714 1,340,737 1,295,191
------- --------- --------- --------- ---------
Total operating expenses.... 519,372 1,628,667 2,070,909 3,105,199 4,138,784
------- --------- --------- --------- ---------
Net loss........................ $(501,872) $(1,628,667) $(2,020,012) $(2,839,759) $(3,717,835)
======= ========= ========= ========= =========
Net loss per
common share(1)............... $ (0.16) $ (0.45) $ (0.50) $ (0.56) $ (0.63)
Weighted average number
of common shares
outstanding
(in thousands)(1)............. 3,177 3,613 4,026 5,037 5,876
</TABLE>
<TABLE>
<CAPTION>
Six Months Ended June 30,
-------------------------
1995 1996
---- ----
<S> <C> <C>
Statement of Operations Data:
Revenues:
Research income............... $ 0 $ 0
Interest income............... 82,224 253,699
--------- ---------
Total revenues.............. 82,224 253,699
Operating expenses:
Research and development...... 1,273,221 2,356,395
General and administrative.... 645,824 1,309,029
------- ---------
Total operating expenses.... 1,919,045 3,665,424
--------- ---------
Net loss........................ $(1,836,821) $(3,411,725)
========= =========
Net loss per
common share(1)................ $(0.36) $(0.49)
Weighted average number
of common shares
outstanding
(in thousands)(1)............. 5,058 6,971
</TABLE>
--------
(1) See Note 1 of the Notes to the Financial Statements for information
concerning the computation of net loss per common share.
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<TABLE>
<CAPTION>
December 31,
------------
1991 1992 1993 1994 1995
---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C>
Balance Sheet Data:
Cash and cash equivalents... $416,149 $164,648 $7,516,941 $1,193,999 $10,406,605
Securities available for sale(2) 0 0 0 3,291,128 502,020
Working capital............. 218,132 29,031 7,207,265 4,447,080 10,510,024
Deficit accumulated during (1,193,601) (2,822,268) (4,842,280) (7,682,039) (11,399,874)
the development stage.......
Total stockholders' equity.. 218,732 29,031 7,240,866 4,479,982 10,577,174
</TABLE>
<TABLE>
<CAPTION>
June 30, 1996
-------------
As
Actual Adjusted(3)
------ --------
<S> <C> <C>
Balance Sheet Data:
Cash and cash equivalents... $10,709,940 $34,722,440
Securities available for sale(2) 0 0
Working capital............. 10,065,731 34,078,231
Deficit accumulated during
the development stage....... (14,811,599) (14,811,599)
Total stockholders' equity.. 10,117,167 34,129,667
</TABLE>
- --------
(2) See Note 2 of the Notes in the Financial Statements.
(3) Adjusted to reflect the sale by the Company of the 1,000,000 Shares at
an assumed offering price of $25.75 per Share, the closing price of the
Company's Common Stock on October 18, 1996 (after deducting
underwriting discounts and commissions and estimated offering
expenses), and the application of the estimated net proceeds therefrom.
See "Use of Proceeds" and "Capitalization".
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MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Overview
OXiGENE is a development-stage pharmaceutical company 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. OXiGENE has devoted substantially all of its
efforts and resources to research and development conducted on its own behalf
and through strategic collaborations with clinical institutions and other
organizations, particularly the University of Lund in Lund, Sweden.
Consequently, OXiGENE believes that its research and development expenditures
have been somewhat lower than other comparable development stage companies.
OXiGENE has generated a cumulative net loss of approximately $14.8 million for
the period from its inception through June 30, 1996. OXiGENE expects to incur
significant additional operating losses over at least the next several years,
principally as a result of its continuing clinical trials and anticipated
research and development expenditures. The principal source of OXiGENE's
working capital has been the proceeds of private and public equity financings.
As of June 30, 1996, OXiGENE had no long-term debt or loans payable. Since its
inception, the Company has had no material amount of licensing or other fee
income, and does not anticipate any such income for the foreseeable future.
Results of Operations
Six Months Ended June 30, 1996 and 1995
During the six month periods ended June 30, 1996 and 1995, the Company
had no revenues, except approximately $0.3 million and $0.1 million of interest
income, respectively. The Company's total operating expenses for those periods
were approximately $3.7 million and $1.9 million, respectively. Research and
development expenses for the six month period ended June 30, 1996 increased to
approximately $2.4 million from approximately $1.3 million for the comparable
1995 period. The increase in reported research and development expenses was
attributable to a charge for financial reporting purposes of approximately $1.0
million. This charge was recorded because the market value per share of Common
Stock on June 30, 1996 ($25.50) exceeded the exercise price of stock
appreciation rights previously granted by the Company to certain clinical
investigators and consultants. Without giving effect to such charge, research
and development expenses increased by approximately $0.1 million compared to
the comparable 1995 period. Generally, the Company makes payments to its
clinical investigators if and when certain predetermined milestones in its
clinical trials are reached, rather than on a fixed quarterly or monthly basis.
As a result of the foregoing and the existence of outstanding stock
appreciation rights, research and development expenses have fluctuated, and are
expected to continue to fluctuate, from quarter to quarter. General and
administrative expenses for the six month period ended June 30, 1996 increased
to approximately $1.3 million from approximately $0.6 million for the
comparable 1995 period. The increase in general and administrative expenses is
primarily attributable to (i) investment banking fees paid to D. Carnegie AB
("Carnegie") of Stockholm, Sweden and (ii) start-up expenses related to
establishing OXiGENE's subsidiary in Sweden. In an effort to preserve cash and
reduce cash flow requirements, the Company's policy has been to minimize the
number of employees and to use outside consultants to the extent practicable.
OXiGENE expects that its clinical trial expenses will increase significantly as
it proceeds with and expands the Sensamide(TM)/Neu-Sensamide(TM) clinical trial
program and it initiates research and clinical trials on new compounds,
including Oxi-104.
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Three Year Period Ended December 31, 1995
Year Ended December 31, 1995 Compared to Year Ended December 31, 1994.
OXiGENE had no revenues, except for approximately $0.4 million and $0.3 million
of interest income in the years ended December 31, 1995 and 1994, respectively.
The increase in interest income is attributable to the investment of the net
proceeds received by the Company from a private placement financing completed
in July 1995. Total operating expenses for the year ended December 31, 1995
increased to approximately $4.1 million from approximately $3.1 million for the
comparable 1994 period. Research and development expenses for the year ended
December 31, 1995 increased to approximately $2.8 million from approximately
$1.8 million for the comparable 1994 period, while general and administrative
expenses remained virtually unchanged. The increase in operating expenses is
primarily due to (i) the costs and expenses associated with an expansion of the
clinical trial program, (ii) increases in research and development activities
in connection with OXiGENE's new compounds, and (iii) the expenses related to
OXiGENE's subsidiary in Sweden.
Year Ended December 31, 1994 Compared to Year Ended December 31, 1993.
OXiGENE had no revenues, except for interest income of approximately $0.3
million and $0.1 million in the years ended December 31, 1994 and 1993,
respectively. Total operating expenses for the year ended December 31, 1994
increased to $3.1 million from $2.1 million for the comparable 1993 period,
reflecting increased clinical trial activities. OXiGENE's research and
development expenses for the year ended December 31, 1994, increased to
approximately $1.8 million from approximately $0.9 million in the comparable
1993 period. The increase in research and development expenses was primarily
due to the commencement of OXiGENE's Phase II/III clinical trials of
Sensamide(TM) and additional research and development efforts. OXiGENE's
general and administrative expenses for the year ended December 31, 1994,
increased to approximately $1.3 million from $1.2 million in the comparable
1993 period.
Liquidity and Capital Resources
OXiGENE has experienced net losses and negative cash flow from
operations each year since its inception and, as of June 30, 1996, had a
deficit during the development stage of approximately $14.8 million. The
Company expects to incur substantial additional expenses, resulting in
significant losses, over at least the next several years due to, among other
factors, its continuing clinical trials and anticipated research and
development activities. To date, the Company has financed its operations
principally through the net proceeds it has received from private and public
equity financings.
In July 1995, OXiGENE completed a $10.0 million private placement with
net proceeds to the Company of approximately $9.5 million. Carnegie acted as
placement agent for this transaction. The Company has used, and anticipates
that it will continue to use, the proceeds from the private placement for
current and expanded clinical trials and for research and development
activities. OXiGENE had cash, cash equivalents and marketable securities of
approximately $10.7 million and $10.9 million at June 30, 1996 and December 31,
1995, respectively. The relatively minor decrease in cash equivalents is due to
the receipt by OXiGENE of approximately $1.7 million from the exercise of
outstanding options and warrants during the six month period ended June 30,
1996, offset by net cash used in operating activities during the six months
ended June 30, 1996, of $1.9 million.
OXiGENE's policy is to contain its fixed expenditures by maintaining a
relatively small number of employees and relying as much as possible on outside
services for its research, development, preclinical testing and clinical
trials. Quarterly payments are being made to the University of Lund,
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Lund, Sweden, for preclinical research and clinical trials. For the years ended
December 31, 1995, 1994 and 1993, the amount of such retainer was approximately
$0.2 million, $0.4 million and $0.1 million, respectively. The significant
increase in the amount paid to the University of Lund prior to 1995 is due to
the fact that clinical trial expenses were billed to the Company through the
University of Lund. Since 1995, such expenses have been paid by the Company
directly. Accordingly, the amount paid to the University of Lund decreased
correspondingly. For the six-month period ended June 30, 1996 such amount was
approximately $0.1 million. In addition, in late 1991, OXiGENE engaged Cato
Research, Ltd. ("Cato") Durham, North Carolina, an independent clinical
research firm, to, among other things, monitor OXiGENE's clinical trials. The
amount billed to OXiGENE by Cato during the years ended December 31, 1995, 1994
and 1993 was approximately $0.7 million, $0.6 million and $0.5 million,
respectively. The continuous increase in the amount billed by Cato reflects the
expenses associated with OXiGENE's Phase II/III clinical trial for
Sensamide(TM) and monitoring and supporting the development of
Neu-Sensamide(TM). For the six month period ended June 30, 1996, the amount
paid to Cato was approximately $0.4 million. Further, in May 1996, in
collaboration with ILEX(TM) Oncology Inc. ("ILEX"), a contract research
organization in San Antonio, Texas, the Company established a large-scale
synthesis of Oxi-104 in accordance with FDA current U.S. Good Laboratory
Practice standards ("cGLP"). To date, the Company has paid ILEX approximately
$0.3 million. As the research and development with respect to Oxi-104 continue,
the Company expects that the amounts payable to ILEX from time to time will
increase significantly.
OXiGENE anticipates that the net proceeds of this Offering, together
with its available cash, cash equivalents, investment securities and investment
income, should be sufficient to satisfy OXiGENE's projected cash requirements
for approximately 30 months from the date of this Prospectus. See "Use of
Proceeds." However, working capital and capital requirements may vary
materially from those now planned due to numerous factors including, but not
limited to, the progress with preclinical testing and clinical trials; progress
of the Company's research and development programs; the time and costs required
to obtain regulatory approvals; the resources the Company devotes to
manufacturing methods and advanced technologies; the ability of the Company to
obtain collaborative or licensing arrangements; the cost of filing, prosecuting
and, if necessary, enforcing patent claims; the cost of commercialization
activities and arrangements; and the demand for its products if and when
approved. The Company anticipates that it will have to seek substantial
additional private or public financing or enter into a collaborative
arrangement with one or more third parties to complete the development of any
product or bring products to market. See "Use of Proceeds." There can be no
assurance that additional financing will be available on acceptable terms, if
at all.
OXiGENE has no material commitments for capital expenditures as of
September 30, 1996.
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BUSINESS
Introduction
OXiGENE, Inc. 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 have 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 as 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 have 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.
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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 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.
Technology Overview
OXiGENE's proprietary technology is based on the relationship between
DNA repair and DNA damage as affected by both the operation of ADPRT (a DNA
repair enzyme) and cell replication. Normal cells in the human body are
constantly subjected to external assault from harmful environmental agents such
as the sun's ultraviolet rays, toxic chemicals in the diet and carcinogens such
as smoke that are absorbed into the body, as well as from internal assault from
metabolic byproducts produced within the cell. These assaults cause damage, or
genetic lesions, to the DNA molecules, which contain the genetic blueprint
(instructions) for the cell. The cell's structural integrity is dependent on
its ability to read and translate those blueprints. Repairing DNA damage is,
therefore, essential to a cell's survival.
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Consequently, the body attempts to counter this constant assault through its
genetic mechanisms that monitor genetic lesions to a cell's DNA molecules and
to repair them enzymatically.
Repair enzymes move constantly along the DNA molecule seeking out
genetic lesions and attempting to repair them through a process called
"excision repair." One of these enzymes is ADPRT. It identifies a genetic
lesion, attaches to the damaged site and engages other enzymes to help in the
repair process. The injured portion of the DNA molecule is then removed by
enzymatic digestion and additional enzymes repair the damage to that part of
the molecule. As DNA is a double helix composed of diametrically opposed
strands, the repair enzymes can use the unaffected strand of nucleotides (the
class of nucleic acid compounds from which genes are constructed) as a template
for determining the correct nucleotides to serve as replacement for the injured
portion that has been removed. The process is completed by the repair enzymes,
which produce the "complementary twin" and implant it in the previously removed
damaged section.
[GRAPHIC OMITTED]
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The excision repair process is selective in that it concentrates on
active regions of the DNA helix; i.e., those containing the genes that are most
vital to the cell. Thus, when the rate of damage to a cell is more than the
repair system can handle, generally the repair mechanism first repairs lesions
in a cell that occur in frequently read genes, which are the genes that are
important to a cell's day-to-day survival. Damage occurring to inactive or
structural portions of the DNA that are not immediately important to a cell's
survival is repaired only as time permits, if at all. Therefore, OXiGENE
believes that cells become malignant or age by the accumulation of genetic
lesions that the DNA repair system has failed to correct properly or in a
timely manner.
[GRAPHIC OMITTED]
The process of DNA repair in the human body
Throughout life, cells replicate by division. Cell division
(replication) occurs very quickly and defects are unavoidable. Genetic defects
constitute a serious threat to a cell's survival. A persistent genetic defect,
or mutation, increases the risk of disease and death. Cancer is a disease in
which a mutated tumor cell divides uninterruptedly and in an uncontrolled
manner. Normal cells die because tumor cells exhaust their nourishment,
inhibiting a normal cell's ability to survive and eventually leading to organic
malfunctions and possibly death.
Traditionally, cancer treatment has been based on the theory that
stopping uncontrolled cell division can halt or slow tumor growth. Both
radiation and chemotherapy increase DNA damage in tumorous cells, causing
toxicity and cell death. Tumorous cells are known to die by either of two
mechanisms, necrosis (death with cell replication) and apoptosis (death without
cell replication). OXiGENE's main product line of DNA repair inhibitors are
based on N-substituted benzamides, which, the Company believes, cause tumor
toxicity primarily by apoptosis. Apoptosis is initiated by cells as an
alternative to necrosis, or mutation. The advantage of apoptotic death is that
it allows normal living cells to absorb the various components that make up the
apoptotic, dying cells without further enzymatic digestion of the cellular
components as occurs with necrotic cell death. Accordingly, apoptosis causes
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cell death without the many toxic side effects associated with necrosis and
enzymatic digestion. This is an important basis for OXiGENE's product research
and development since its goal is to create drugs to counteract cancer that are
also less hazardous to the individual than those used today.
DNA Repair Inhibition. Cancer therapy typically involves either or both
of surgery, to remove the primary tumor, and the application of cytotoxic
(cell-killing) agents, such as radiation or chemotherapy, to destroy primary
and secondary tumors that are too small, diverse or broadly spread to be
removed surgically (called metastases). Nearly all available radiation and
chemotherapies work by increasing DNA damage to tumor cells, thus blocking
those cells' replication and inhibiting their growth by necrosis or apoptosis,
or both, and eventually leading to their death. As tumorous cells replicate
substantially more frequently than normal cells, the body's normal DNA repair
mechanism tends to counteract the effects of radiation and chemotherapy
treatment by promoting the replication, or "regrowth," of the very tumors that
have been treated. The Company believes that this process may be prevented by
inhibiting the body's normal repair mechanism. Further, the Company believes
that certain chemical compounds are capable of serving as "sensitizers," which
supplement the radiation or chemotherapy phase of cancer treatment by
inhibiting DNA repair of the tumor cell and increasing DNA damage, thereby
increasing the efficiency of the cytotoxic agents. Drugs that exhibit
sensitizing properties permit an oncologist to elect either to achieve greater
results with a given dose of radiation therapy or chemotherapy, or to reduce
the level of the cytotoxic agent needed to achieve the same result. Frequently,
however, oncologists must cut short therapy because side effects associated
with certain sensitizing agents become intolerable before effective tumor
killing can occur. The Company believes that its principal products are
sensitizers that should be capable of inhibiting DNA repair of the tumor cell
and increasing DNA damage without intolerable side effects when used in
conjunction with traditional cancer treatments. See "OXiGENE's DNA Repair
Products and Clinical Trial Program."
DNA Repair Measurement and Stimulation The ADPRT enzyme is an important
enzyme in the DNA repair process because it recognizes DNA damage and alters
certain proteins in the damaged site, enabling the other repair enzymes to gain
access to that site and to complete the excision repair process. Therefore, the
Company believes that if an individual's level of ADPRT is high, DNA repair is
being facilitated and DNA damage is being removed, and if an individual's level
of ADPRT is low, DNA repair is being inhibited and DNA damage will accumulate.
Consequently, by measuring individual levels of ADPRT, the Company believes it
is possible to determine how well the DNA repair process is functioning in
preventing accumulated DNA damage. OXiGENE believes that knowledge of DNA
repair activity may be useful for monitoring or screening individuals for
susceptibility to cancer, immune deficiencies, chemotherapeutic drug resistance
and the success or failure of chemopreventive treatment.
OXiGENE believes that knowledge of the body's metabolic function and
its related process known as "oxidative stress," in which a small number of
metabolic "mistakes" occur and cause the formation of certain intermediates
that damage DNA, and knowledge of the body's inflammatory response that causes
a decline in DNA repair, may lead to the development of drugs that may
stimulate DNA repair. Drugs of that type, the Company believes, could reduce a
person's susceptibility to cancer and certain diseases associated with the
aging process by increasing net DNA repair capacity.
Although the Company has conducted extensive preclinical cell and
animal research into each of the areas of DNA repair measurement and DNA repair
stimulation, and is currently planning the early stages of their clinical
development, there can be no assurance that any drugs related to either of
these areas can or will be developed by the Company. See "-- OXiGENE's DNA
Repair Products and Clinical Trial Program."
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Product Development and Marketing Strategy
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 and death of, tumor
cells. The Company intends to continue and expand its ongoing clinical trial
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, directly in certain European countries, it has had preliminary
discussions with unaffiliated pharmaceutical companies regarding 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.
Currently, the Company has collaborative arrangements with the
University of Lund in Lund, Sweden, the Strang Cancer Prevention Center in New
York, New York, New York University in New York, New York, Gray Laboratory in
Middlesex, United Kingdom, Aarhus University in Aarhus, Denmark, Institut de
Biologie Moleculaire et Cellulaire in Strasbourg, France and Georgetown
University in Washington, D.C. See "Research and Development and Collaborative
Arrangements."
In particular, the Company believes that its collaborations with the
University of Lund enable it to conduct clinical trials of its products in an
environment offering a more homogenous patient population at less cost and more
rapidly than the Company could achieve in the United States. The University of
Lund has historically provided, and continues to provide, the Company with
access to clinical trial facilities, patients and research facilities.
Additionally, the Company benefits indirectly from certain research grants
received by the University of Lund.
OXiGENE's DNA Repair Products and Clinical Trial Program
DNA Repair Inhibiting Products
OXiGENE has discovered certain compounds in the family of N-substituted
benzamides that it believes should be capable of inhibiting ADPRT-modulated DNA
repair and selectively reacting with radiation to cause additional DNA damage
preferentially in the treated area. OXiGENE believes that this selectivity is
due to tumor cells exhibiting increased DNA repair activity as compared to
normal cells, rendering them more sensitive to DNA repair inhibition and death
by apoptosis. The Company believes, on the basis of its research activities to
date, that its principal products, Sensamide(TM) and Neu-Sensamide(TM), should
act as selective, targeted sensitizers of tumor tissue and sensitize radiation
preferentially inside the treated area without producing significant toxic side
effects outside the treated area.
Oxi-104, the Company's newest compound, is not based on metoclopramide
and, therefore, although it is classified as an N-substituted benzamide, it is
unlike Sensamide(TM) or Neu-Sensamide(TM). The Company believes that Oxi-104
alone may induce tumor growth-inhibiting and tumor-killing effects. 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. For the Company's two
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radiation sensitizer products, Sensamide(TM) and Neu-Sensamide(TM), both of
which are based on an N-substituted benzamide known as metoclopramide,
currently the limiting doses are determined by their central nervous system
(CNS) side effects. By comparison, Oxi-104 has not yet shown in animal studies
any CNS side effects.
The current emphasis of the Company's clinical trial program is on
evaluating the safety and efficacy of Sensamide(TM) and Neu-Sensamide(TM) as
sensitizing agents in combination with radiation therapy, with the goal of
obtaining approval for Neu-Sensamide(TM) as a radiation sensitizer not limited
to a specific form of cancer. In the middle of 1994, the Company commenced a
226-patient European, randomized, controlled Phase II/III clinical trial of
Sensamide(TM) in patients with inoperable non-small cell lung cancer ("NSCLC").
In the fourth quarter of 1996, the Company intends to commence a 226-patient
European, randomized, controlled Phase III clinical trial of Neu-Sensamide(TM)
in patients with NSCLC. The combined results of the Sensamide(TM) and
Neu-Sensamide(TM) studies are intended to serve as the basis of the Company's
NDA for Neu-Sensamide(TM) as a radiation sensitizer for NSCLC. In August 1996,
the Company commenced 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. 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.
OXiGENE is collaborating with ILEX, a contract research organization
based in San Antonio, Texas, on the development of Oxi-104. ILEX will conduct
pre-clinical development work through the intended filing of an IND on a
contract basis. This work will include pharmacokinetics studies, toxicology
studies in accordance with cGLP standards, process development,
scale-up/manufacturing for anticipated clinical trial needs under FDA current
good manufacturing practice ("cGMP") standards, analytical development, and the
intended compilation and submission of an IND. OXiGENE anticipates having a
pre-IND meeting with the FDA regarding Oxi-104 in February 1997. This
collaboration agreement commenced in May 1996 and continues until the
completion of services thereunder as mutually agreed upon by the parties
provided that OXiGENE has the right to terminate such agreement upon 30 days
written notice. Generally, OXiGENE has the option to acquire an exclusive,
worldwide, royalty free license and related know-how to any invention made by
employees or agents of ILEX arising out of work performed pursuant to the
obligations under the agreement, provided that OXiGENE pays all reasonable and
appropriate costs and expenses associated with patent and copyright filing,
prosecution, issuance and maintenance. If ILEX licenses rights to any invention
to a third party, ILEX and OXiGENE will negotiate to pay OXiGENE a reasonable
royalty consistent with rates found in the industry.
The Company currently anticipates commencing a Phase I clinical trial
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.
A summary of the clinical trials related to the Company's products that
are currently under development is set forth in the following table (which is
supplemented further by the more detailed information contained in Appendix I
hereto):
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<TABLE>
Summary of OXiGENE's Clinical Trial Program
<CAPTION>
Total Treatment
Study Phase Country patients Randomization Assignment Status
- ----------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C>
Sensamide(TM)in I/II Sweden 23 None All patients on Published
NSCLC Sensamide(TM)(i.v.) 1995
with radiation
- ----------------------------------------------------------------------------------------------------------------------------------
Sensamide(TM)in II/III Norway, 226 Control Sensamide(TM) Ongoing;
NSCLC Denmark, (i.v.) with 185 patients
Sweden, radiation - 113; enrolled as
Germany Radiation only - of Octo-
and United 113 ber 14,
Kingdom 1996; report
third quarter
1997
- ----------------------------------------------------------------------------------------------------------------------------------
Comparative I United 19 Placebo, Placebo-12; Report
study in healthy Kingdom double-blind Sensamide(TM)(i.v.) September
volunteers of cross-over -15; Neu- 1995
Sensamide(TM), Sensamide(TM)(i.v.)
Neu-Sensamide(TM) - 13;
and Placebo Neu-Sensamide(TM)
(i.m.) - 13
- ----------------------------------------------------------------------------------------------------------------------------------
Neu-Sensamide(TM) I/II Sweden 15 None Neu-Sensamide(TM) Ongoing; 2
in glioblastomas (i.m.) - 15 patients
enrolled as
of Octo-
ber 14, 1996
- ----------------------------------------------------------------------------------------------------------------------------------
Neu-Sensamide(TM) III Europe 226 Control Neu-Sensamide(TM) Estimated
in NSCLC and United (i.m.) with start fourth
States radiation - 113; quarter 1996
Radiation only -
113
- ----------------------------------------------------------------------------------------------------------------------------------
Oxi-104 in I United 15 None All patients on Planning
refractory cancer States Oxi-104 phase
(solid tumors)
</TABLE>
Certain terms and abbreviations used in the foregoing table are explained in
the Glossary.
DNA Repair Measuring Products
ADPRT Assay Products. The Company believes that its knowledge of DNA
repair activity may be applied to monitor or screen individuals for
susceptibility to cancer, immune deficiencies and chemotherapeutic drug
resistance. Studies have shown that DNA repair capacity may vary from one
individual to another. OXiGENE has quantified individual levels of ADPRT as a
DNA repair estimate. The Company holds an exclusive worldwide license, which
expires in 2011, to issued Canadian, U.S. and European patents and a pending
Japanese patent application covering an ADPRT diagnostic test that
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measures ADPRT levels in white blood cells. The Company believes that a simple
and inexpensive serum-based test may give a reliable surrogate indication of
the level of ADPRT in white blood cells. OXiGENE has filed a U.S. patent
application in October 1994, with respect to such a test.
The New York University Medical Center, Department of Environmental
Medicine and the Center of Aids Research have conducted an investigation using
OXiGENE's assay for measuring ADPRT levels (i.e., a serum thiol-based surrogate
test) on 133 patients who were intravenous narcotic drug users and were
infected with the HIV virus that causes AIDS. The Company believes that this
repair assay may assess DNA repair activity by measuring total serum thiol
levels. The Company believes that preliminary results of this investigation
indicate that this assay may be effective in monitoring the progression of
HIV-related diseases. The Company believes that measuring a person's immune
function through DNA repair activity may be a better indication of HIV-related
disease progression and, consequently, survival than more commonly used
indicators such as CD4 cell counts. The Company intends to pursue the
development of a more-cost-effective, easy-to-administer version of the assay
for commercialization.
DNA Repair Stimulating Products
Cancer, as well as the general deterioration of the body leading to
aging disorders connected to immunity, is generally recognized in medicine as a
mutational disease arising from the build-up of genetic damage in unrepaired
areas of DNA. By enhancing DNA repair in the inactive areas of the DNA
structure, genetic damage build-up may be reduced with a reduction in cell
mutation. OXiGENE research in this area has to date concentrated on identifying
compounds that, the Company believes, may slow the natural production of DNA
repair inhibitors produced by the body when inflammatory cells are activated as
an early defense against infections or cancer cells. The Company believes,
based on its research to date, that by blocking this natural production of DNA
repair inhibitors by inflammatory cells, a net increase in DNA repair capacity
can be achieved.
The Company has developed a screening method based on DNA repair
measurements of in vivo-exposed spleen and cells. The Company has identified a
new mixture of naturally-occurring compounds that it believes should be capable
of stimulating DNA repair, and which is currently under evaluation by the
Company in cell and animal models to improve enhancement of DNA repair. OXiGENE
has filed an international (PCT) patent application for this mixture of
potential DNA repair stimulators.
The Company believes that DNA repair enhanced compounds may be used to
supplement, or under certain circumstances replace, chemopreventive or cancer
retardant agents for cancer already in use, such as Tamoxifen(TM), as well as
chemopreventive agents in various stages of development. Any DNA repair
enhancer drugs currently being developed by OXiGENE are expected to be based on
naturally occurring compounds, rather than synthetic analogs. Consequently, the
Company believes that they may be less inherently toxic than newly-synthesized
chemopreventive agents already in clinical trials. However, there can be no
assurance that the Company will be able to develop any such drug, or if
developed, that such drug could be successfully marketed.
Product Development and Regulatory Processes
Research initially involves optimization of leading chemical structures
into leading compounds. Once a leading compound has been identified, the
preclinical phase commences. In that phase, certain selected compounds are
tested for therapeutic potential in a number of animal models and undergo
laboratory testing, with the objective of characterizing the investigated
compounds in relation to existing
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treatment and getting a first indication of the compounds' development
potential. Successful preclinical work may lead to the filing of an IND, or a
foreign equivalent, with the relevant national regulatory authorities. The IND
is a permission to administer the compound to humans in clinical trials.
Several years of research and testing generally are necessary before an IND can
be obtained and clinical development commence. There can be no certainty that
submission of an IND will result in FDA authorization to commence clinical
trials or that authorization of a particular phase of a clinical trial program
will result in authorization of other phases or that the completion of any
clinical trials will result in FDA approval.
The clinical development of new drugs is subject to approval by the
health authorities in individual countries, which have broad discretionary
powers. For example, the FDA reviews the results of all clinical studies and
can discontinue a trial at any time if there is a significant safety issue, or
if there is convincing evidence that the therapy is not effective for the
chosen indication. The duration of the clinical phase requirements among
countries vary considerably. For life threatening and severely debilitating
conditions where products provide meaningful therapeutic benefit over existing
treatments or where no satisfactory treatment currently exists, however, it is
possible to accelerate the development process in the United States through the
"Accelerated Drug Approval Program." In other countries, the trial process for
drugs directed toward life threatening diseases is shortened by lower
requirements regarding the patient sample size required to be met in the
trials.
The time periods mentioned below are indications only and may vary and
be materially longer. Upon successful completion of the development program, a
New Drug Application ("NDA"), or a foreign equivalent, may be submitted to the
authorities, and, if approved, the product may then be marketed upon the terms
and conditions of such approval. Submission of an NDA does not assure that the
FDA will approve a product for manufacturing and marketing. Clinical trials are
typically conducted in three sequential phases, but the phases may overlap.
Phase I. The purpose of a Phase I study is to evaluate the toxicity of
the tested compound and to establish how the tested compound is tolerated and
decomposed in the human body. A Phase I clinical trial traditionally tests the
compound for safety (adverse effects), dosage tolerance, metabolism,
distribution, excretion and pharmacodynamics in a small group of healthy
individuals. A Phase I may last up to one year.
Phase II. A Phase II study marks the beginning of clinical trials on a
limited number of patients to (i) determine the efficacy of the compound for
specific indications, (ii) determine dosage tolerance and optimal dosage and
(iii) identify possible adverse effects and safety risks. The trials also seek
to establish the most effective route of administration. Trials are conducted
on a larger, but still limited number of carefully monitored patients. A Phase
II may last up to two and one-half years.
Phase III. If preliminary evidence suggesting effectiveness has been
obtained during Phase II evaluations and the compound is found to have an
acceptable safety profile in Phase II evaluations, a Phase III trial is
undertaken. A Phase III is an extensive clinical trial in a large number of
patients. The number of patients in a Phase III trial program depends to a
great extent on the clinical indications that the drug addresses. Trials are
often double-blinded and involve a detailed statistical evaluation of test
results. The compound is tested against placebo and existing treatment, if such
treatment is available. The product is manufactured in commercial quantities
and tested for shelf life, or stability, and further evaluation of the clinical
efficacy and safety of the compound takes place. Phase III may last several
years and is the most time-consuming and expensive part of a clinical trial
program. There can be no
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assurance that Phase I, Phase II or Phase III testing will be completed
successfully within any specified time period, if at all, with respect to any
of the Company's products.
OXiGENE, like other pharmaceutical companies, will be subject to strict
controls covering the manufacture, labeling, supply and marketing of any
products it may develop and market. The most important regulation is the
requirement to obtain and maintain regulatory approval of a product from the
relevant regulatory authority to enable it to be marketed in a given country.
Further, OXiGENE is subject to strict controls over clinical trials of its
potential pharmaceutical products.
The regulatory authorities in each country may impose their own
requirements and may refuse to grant, or may require additional data before
granting, an approval even though the relevant product has been approved by
another authority. The United States and European Union ("EU") countries have
very high standards of technical appraisal and, consequently, in most cases a
lengthy approval process for pharmaceutical products. The time required to
obtain such approval in particular countries varies, but generally takes from
six months to several years, if at all, from the date of application, depending
upon the degree of control exercised by the regulatory authority, the duration
of its review procedures and the nature of the product. The trend in recent
years has been towards stricter regulation and higher standards.
In the United States, the primary regulatory authority is the FDA. In
addition to regulating clinical procedures and processes, the FDA investigates
and approves market applications for new pharmaceutical products and is
responsible for regulating the labeling, marketing and monitoring of all such
products, whether marketed or under investigation. Upon approval in the United
States, a drug may only be marketed for the approved indications in the
approved dosage forms and dosages. In addition to obtaining FDA approval for
each indication to be treated with each product, each domestic drug
manufacturing establishment must register with the FDA, list its drug products
with the FDA, comply with cGMP requirements and be subject to inspection by the
FDA. Foreign manufacturing establishments distributing drugs in the United
States also must comply with cGMP requirements and list their products and are
subject to periodic inspection by the FDA or by local authorities under
agreement with the FDA.
In Europe, the European Committee for Proprietary Medicinal Products
provides a mechanism for EU-member states to exchange information on all
aspects of product licensing and assesses license applications submitted under
two different procedures (the multistate and the high-tech concentration
procedures). The EU has established a European agency for the evaluation of
medical products, with both a centralized community procedure and a
decentralized procedure, the latter being based on the principle of mutual
recognition between the member states.
There can be no assurances that any of the Company's products will ever
obtain the governmental approvals necessary to permit commercial sales of any
of its products. See "Risk Factors--Early Stage of Development; Uncertainties
of Clinical Trials; Unproven Safety and Efficiency."
Research and Development and Collaborative Arrangements
The Company's research and development programs are generally pursued
in collaboration with academic and other institutions. Under current
arrangements, the Company is not required to pay any royalties or licensing
fees for technology and products developed with financial assistance from or at
the facilities of such agencies and institutions, except for a 5% gross royalty
payable in respect of an exclusive worldwide license of the patent covering the
ADPRT diagnostic assay and certain costs related
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to the filing, prosecuting and maintaining of patents and copyrights. There can
be no assurance that royalties or fees, potentially material as to their
amount, will not be required under any future arrangements.
The Company incurred approximately $0.9 million, $1.8 million and $2.8
million in research and development expenses in the years ended December 31,
1993, 1994 and 1995, respectively. For the six month period ended June 30,
1996, such expenses were approximately $2.4 million. Substantially all of these
amounts represent external research and development expenditures.
Swedish Cancer Society. In 1992, the Swedish Cancer Society awarded Dr.
Ronald Pero, in his capacity as a faculty member of the University of Lund, a
three-year grant for a total of approximately $0.3 million to investigate
benzamide and nicotinamide analogs relating to Sensamide(TM) as
radiosensitizers. This grant was renewed in 1995 for a one year period totaling
approximately $0.2 million. The Company was not the recipient of any of these
funds. The study's principal objective was to determine what chemical features
give benzamide/nicotinamide compounds multiple forms of radiosensitizing
action.
In 1992, Dr. Pero, in his capacity as a faculty member of the
University of Lund, was awarded another Swedish Cancer Society research grant
(principal investigator Professor Goran Berglund), for a total of approximately
$0.4 million over a three-year period, to direct the biological bank and
biomarker program portion of the Malmo Diet Study. This project has had its
funding renewed until October 1996, the anticipated date of completion of
patient enrollment. The Company was not the recipient of any of these funds.
The Malmo Diet Study, sponsored in part by the World Health Organization,
involves a large ongoing controlled case study in which individuals between the
ages of 46 years and 64 years, living in the city of Malmo, Sweden, have been
invited to participate in a study designed to evaluate dietary factors as
causative agents for cancer. The city of Malmo was selected as the site of this
study because of the historically high incidence of cancer in its relatively
homogeneous population.
University of Lund/Strang Cancer Prevention Center Agreement. In 1987,
the University of Lund entered into a research collaboration agreement with the
Strang Cancer Prevention Center in New York City. The purpose of the
collaboration is to develop biomarkers and to contribute to the basic knowledge
of DNA repair in relation to human diseases. The program is conducted primarily
in the Wallenberg Laboratory of the University of Lund. Dr. Pero was appointed
to head this international collaborative effort and was awarded professorial
privileges and laboratory space, which is currently being used by Dr. Pero and
his research colleagues. Initially, Dr. Pero's salary was paid by the Strang
Cancer Prevention Center, but in 1990 that responsibility was assumed by the
Company. The Wallenberg Laboratory specializes in providing research space to
selected research projects being developed within the academic community.
Currently, the program focuses its research efforts on immunology and tumor
biology, areas directly related to the Company's technology development. Most
of the Company's research, development, preclinical testing and clinical trials
are carried out at the Wallenberg Laboratory, financed by research grants and
contracts. The University of Lund has not claimed any proprietary interest in
the products developed by the Company there.
In April 1994, the Department of Oncology, Lund University Hospital and
the Company entered into an agreement with respect to the multicentered
clinical trial of 226 patients to evaluate Sensamide(TM) as a radiosensitizer.
This agreement provides that the Department of Oncology, Lund University
Hospital will provide all the clinical items necessary for the study in
accordance with the protocol approved by the Swedish Medical Drug Agency.
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Preventive Medicine Institute. Pursuant to an agreement dated October
7, 1991 (the "PMI License Agreement"), between a predecessor of the Company and
Preventive Medicine Institute, a New York not-for-profit corporation affiliated
with the Strang Cancer Prevention Center in New York, New York, the Company
received an exclusive, worldwide license to patent rights and related know-how
covering the ADPRT diagnostic assay, which license expires on October 7, 2011.
The PMI License Agreement requires the Company to pay a royalty equal to 5% of
the total amount of any net revenues received by the Company in respect of the
ADPRT diagnostic assay. To date, the Company has made no royalty payments as
this product has not been commercially developed.
New York University Medical Center. In 1990, Dr. Pero was appointed as
adjunct professor at New York University Medical Center, and was provided with
certain laboratory space. During 1995, Dr. Pero continued to use the space to
conduct research using diagnostic tests as biomarkers of hazardous
environmental exposures, cancer susceptibility and AIDS prognosis while
continuing development of a simple and inexpensive surrogate version of the
assay (test) for commercialization. In 1994, the Company entered into a
preclinical study agreement with New York University Medical Center, pursuant
to which the Company would sponsor a research study entitled "Retrospective
Trial of N-Cloroamine as a Prognostic Indicator of HIV Disease," which is
related to the Company's diagnostic test. The Company paid New York University
approximately $25,000 in connection with this project. In addition, the Company
has agreed to sponsor two research projects of the Department of Environmental
Medicine, New York University Medical Center, which are to be conducted by Dr.
Krystyna Frenkel, PhD. The two projects are (i) the development of an assay
that can serve as a biomarker of risk, which is based on a determination of the
serum thiol status of human serum (plasma); and (ii) the utilization of Malmo
Diet and Cancer biological bank to assess the role of oxidative stress in the
regulation of individual susceptibility to cancer from dietary factors. New
York University Medical Center will receive a total of approximately $82,000
for these projects.
Professor Myron K. Jacobson, The College of Pharmacy, University of
Kentucky. Professor Jacobson is the Chairman of the Division of Medicinal
Chemistry and Pharmaceuticals, College of Pharmacy, University of Kentucky,
Lexington, Kentucky. In November 1994, the Company entered into a consulting
agreement with Professor Jacobson, under which he will assist the Company's
core research and development efforts in the DNA repair area and
ADP-ribosylation. Dr. Jacobson is paid a $5,000 per annum consulting fee and
was granted options to acquire 5,000 shares of the Company's Common Stock at an
exercise price of $5.50 per share. The options fully vest on December 31, 1996,
provided Dr. Jacobson remains a consultant to the Company through that date,
and terminate in 2004.
Dr. Michael Horsman, The Danish Cancer Society, Aarhus, Denmark. Dr.
Horsman entered into a consulting agreement with the Company in November 1994,
under which he will assist the Company's research programs in determining
certain relationships between the Company's drugs and radiation. Dr. Horsman is
paid a $5,000 per annum consulting fee.
Dr. David J. Chaplin, the Gray Laboratory Cancer Research Trust Mount
Vernon Hospital, Middlesex, United Kingdom. Dr. Chaplin is Head of the Tumour
Microcirculation Group at the Gray Laboratory Cancer Research Trust, Mount
Vernon Hospital. Under an agreement signed in May 1995 Dr. Chaplin retains his
position at the Gray Laboratory but is also employed by OXiGENE as Vice
President for Basic Research, Sensitizer Program and serves as the Secretary of
the Company's Scientific Advisory Board. The term of such agreement has been
extended to April 30, 1997. Dr. Chaplin is responsible for planning, on behalf
of the Company, certain preclinical studies to evaluate certain of the
Company's proprietary compounds at the Gray Laboratory and, in conjunction with
Dr. Pero, defining
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and coordinating radio- and chemosensitizing studies of the Company's
proprietary compounds at other research centers. Dr. Chaplin is paid $30,000
per annum and was granted options to purchase 30,000 shares of Common Stock, at
an exercise price of $5.375 per share, vesting in three installments, on June
1, 1995, 1996, and 1997. Gray Laboratory receives the equivalent of
approximately $42,000.
Dr. Sylviane Muller, Le Centre National de la Recherche Scientifique,
(Institut de Biologie Moleculaire et Cellulaire) Strasbourg, France. In
November 1995, the Company entered into a one year research agreement with Le
Centre National de la Recherche Scientifique ("CNRS") pursuant to which OXiGENE
and CNRS will conduct a collaborative study under the supervision of Dr.
Muller, on the "Preparation of Antibodies Reacting Selectively with the
Oxidized Zinc Finger Region of Poly-ADPRT." The Company will pay CNRS the
equivalent of approximately $35,000 for this study.
Dr. Mark Smulson, Georgetown University, Washington D.C. Under a July
1996 research agreement with Georgetown University, Dr. Smulson will conduct
research to clarify the interference of N-substituted benzamides with the
functioning of ADPRT and related enzymes. New inventions or discoveries
conceived or reduced to practice during and as a part of the research performed
pursuant to such agreement solely by Georgetown University's principal
investigator, faculty, staff, employees or students are the sole property of
the University; if such inventions or discoveries are conceived or reduced to
practice jointly by such persons of Georgetown University and one or more
employees of the Company, then such inventions or discoveries are owned jointly
by the Company and Georgetown University. In either event, the Company has a
right of first offer to enter into a royalty bearing license agreement to
practice such new invention or discovery (such license shall be exclusive or
nonexclusive and worldwide except for those countries in which patents are
valid and enforceable and for which the Company does not reasonably assume
responsibility for out of pocket costs associated with obtaining and
maintaining related patents). The agreement terminates on June 30, 1997,
provided that the agreement may be terminated by either party upon thirty days'
prior written notice or upon certain other events. Georgetown University will
receive a total of approximately $72,000 for this study, of which approximately
$36,000 has been paid to date.
Patents and Trade Secrets
Certain of OXiGENE's current products are based on available compounds
that are produced by others. The Company anticipates that any products it
develops hereafter may include or be based on the same or other compounds owned
or produced by unaffiliated parties, as well as synthetic compounds it may
discover. Although the Company expects to seek patent protection for any
compounds it discovers, 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 will continue to be, important to the Company's efforts,
although those processes, as such, may not be patentable.
Patent Protection
It is the Company's policy to seek patent protection in the United
States and in foreign countries. Primarily because of differences among patent
laws in various jurisdictions, the scope of, and hence the protection afforded
by, any patents OXiGENE may receive may vary from jurisdiction to jurisdiction
even though they relate essentially to the same subject matter.
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The patent position of firms in the Company's industry generally
involves highly complex legal and other issues, resulting in both an apparent
inconsistency regarding the breadth of claims allowed in United States patents
and general uncertainty as to their legal interpretation and enforceability.
Accordingly, there can be no assurance that patent applications owned by the
Company will result in patents being issued or that, if issued, the patents
will afford competitive protection.
Further, there can be no assurance that products or processes developed
by the Company will not be covered by third party patents, in which case
continued development and marketing of those products or processes could
require a license under such patents. There can be no assurance that if a legal
action were to be brought against the Company on the basis of any third party
patents, such action would be resolved in the Company's favor. Such an
unfavorable result against the Company could result in monetary damages and
injunctive relief. Further, even a favorable result could cause expenditure of
substantial monetary and other resources in connection with the Company's
defense against any such action.
Granted Patents and Pending Applications
The following is a brief description of the Company's current patent
position, both in the United States and abroad. As U.S. patent applications are
maintained in secrecy by the U.S. Patent and Trademark Office until patents
issue and because publication of discoveries in the scientific or patent
literature often lags behind actual discoveries, OXiGENE cannot be certain that
it was the first creator of inventions covered by its pending applications or
that it was the first to file patent applications for those inventions.
As of October 18, 1996, the 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. Two of the U.S patents
issued in 1996. Three of the pending U.S. applications were filed in 1996, of
which one is a provisional application and another is a U.S.- designating
international application (also designating other countries) based on a U.S.
provisional application filed in 1995.
Specifically, the Company is the assignee of a U.S. patent, granted
April 20, 1993, for glutathione-s-transferase Mu (an inherited enzyme) as a
measure of drug resistance, covering a test for resistance to nitrosoureas (a
class of chemotherapeutic agents). In addition, the Company is the assignee of
a U.S. patent, granted August 23, 1994, for tumor or cancer cell-killing
therapy (covering methods of using N-substituted benzamides including
Sensamide(TM) and Neu-Sensamide(TM) as radio- and chemosensitizers), and of
granted patents in Australia, Canada, Europe (designating 13 countries),
Ireland, Israel, Mexico and South Africa and an allowed patent application in
Russia (as well as pending applications in Denmark and Japan) corresponding
thereto. The Company is also the assignee of two U.S. patents, both granted
October 1, 1996, for methods of administering and pharmaceutical formulations
containing N-substituted benzamides and/or acid addition salts thereof
(covering, e.g., Neu-Sensamide(TM)) and for methods of administering
phenothiazines and/or acid addition salts thereof, and of a granted South
African patent and pending European and other foreign applications
corresponding to these two new U.S. patents. The Company's four pending U.S.
applications and international counterparts cover further methods of testing or
treatment and compositions, including the Oxi-104 compound.
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Moreover, the Company is the exclusive licensee of a U.S. patent,
granted January 9, 1996, for a diagnostic test involving measurements related
to the cellular process of DNA repair and drug resistance, and is the exclusive
licensee of corresponding granted Canadian and European patents and a
corresponding pending Japanese patent application. The owner of the licensed
patents and application is Preventive Medicine Institute, a New York
not-for-profit corporation affiliated with the Strang Cancer Prevention Center
in New York, New York.
Trade Secrets and Technological Know-How
While the Company generally has and will continue to pursue a policy of
seeking patent protection to preserve its proprietary technology, it also has
and will continue to rely on trade secrets, unpatented proprietary information
and continuing technological innovation to develop and maintain its competitive
position. There can be no assurance, however, that others will not
independently develop substantially equivalent proprietary information and
technology or otherwise gain access to such or equivalent trade secrets,
proprietary information or technology or that OXiGENE can meaningfully protect
its rights to such secrets, proprietary information and technology.
OXiGENE generally requires its employees and Scientific Advisory Board
members 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 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 OXiGENE. There
can be no assurance, however, that any such agreement will provide meaningful
protection for the Company's trade secrets, proprietary information or
technology in the event of unauthorized use or disclosure of such information.
Moreover, although the Company has confidentiality agreements with the
institutions that perform its research, development, preclinical tests and
clinical trials, the Company has no such agreements with the employees of such
institutions, and there can be no assurance that these employees will abide by
the terms of such agreements.
Competition
The industry in which the Company is engaged is characterized by
rapidly evolving technology and intense competition. The Company's competitors
include, among others, major pharmaceutical and biotechnology companies, many
of which have financial, technical and marketing resources significantly
greater than those of the Company. In addition, many of the small companies
that compete with the Company have also formed collaborative relationships with
large, established companies to support research, development, clinical trials
and commercialization of products that may be competitive with those of the
Company. Academic institutions, governmental agencies and other public and
private research organizations are also conducting research activities and
seeking patent protection and may commercialize products on their own or
through joint ventures or other collaborations.
The Company is aware of a number of companies engaged in the research,
development and testing of new cancer therapies or ways of increasing the
effectiveness of existing therapies. Such companies include, among others,
Bristol-Myers Squibb Company, Glaxo Wellcome PLC, Eli Lilly and Company,
Ciba-Geigy Ltd., U.S. Bioscience Inc. and Johnson & Johnson, some of whose
products have already received regulatory approval or are in later stages of
clinical trials. The Company is also aware of companies engaged in the
research, development and testing of diagnostic assays for cancer, including
Introgen Therapeutics, AntiCancer Inc., Transgene and Medarex Inc. There are
other companies that
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have developed or are in the process of developing technologies that are, or in
the future may be, the basis for competitive products in the field of cancer
therapy or other products the Company intends to develop. Some of those
products may have an entirely different approach or means of accomplishing the
same desired effects as the products being developed by the Company, such as
gene transfer therapy, immunotherapy and photodynamic therapy. There can be no
assurance that the Company's competitors will not succeed in developing
technologies and products that are more effective, safer or more affordable
than those being developed by the Company.
Radiation therapy has been increasingly accepted as a complement to
chemotherapy in a multi-modality treatment of NSCLC. Further, a number of
organizations have developed new chemotherapeutic regimens that are under study
in late-stage clinical trials. To the best knowledge of the Company, however,
none of those organizations is, and none of the new forms of non-surgical
cancer treatment currently under development and in clinical trials appears to
be, directly competitive with Sensamide(TM) or Neu-Sensamide(TM) as a
sensitizer.
As the Company's existing products are intended to complement and
enhance radiation therapy and chemotherapy as applied to NSCLC, the Company
believes that enhancements in those treatments, particularly if they lead to
their successful application, could increase the potential market for the
Company's products, although there can be no assurance in this regard.
Moreover, if the Company's products also complement new cancer treating
therapies, the use of these new therapies might also expand the Company's
potential market.
The Company expects that if any of its products gain regulatory
approval for sale they will compete primarily on the basis of product efficacy,
safety, patient convenience, reliability, price and patent position. The
Company's competitive position also will depend on its ability to attract and
retain qualified scientific and other personnel, develop effective proprietary
products and implement joint ventures or other alliances with large
pharmaceutical companies in order to jointly market and manufacture its
products.
Employees
The Company's policy has been, and continues to be, to maintain a
relatively small number of executives and other employees and to rely as much
as possible on consultants and independent contractors for its research,
development, preclinical tests and clinical trials. As of October 14, 1996, the
Company had eleven full-time employees, of which seven were engaged in research
and development and monitoring of clinical trials. Most of the Company's
preclinical tests and clinical trials are subcontracted and performed at the
University of Lund, Sweden, and at other European centers, with the assistance
primarily of CATO Research, Ltd., Durham, North Carolina, an independent
clinical research firm, IPC Nordic A/S, a Danish pharmaceutical consulting
firm, and ILEX Oncology Inc., a contract research organization in San Antonio,
Texas.
Properties
The Company subleases its executive offices in New York, New York,
currently at an annual rent of approximately $41,000. The lease expires on
December 31, 1996. The Company believes that it can readily find alternate
executive office space suitable to its needs and at a reasonable cost should it
be required to do so. Recently, the Company opened an executive office in
Stockholm, Sweden, in anticipation of the listing of its Common Stock on the
Stockholm Stock Exchange. The Stockholm office
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is subleased, at an annual rate of approximately $25,000, under an arrangement
that expires in September 1998. The Stockholm office sublease may be terminated
at any time upon nine months written notice. The Company also leases an office
at the Ideon Research Park in Lund, Sweden. The lease expires on January 31,
1998, and the annual rent is approximately $19,500. The Company does not own or
lease any laboratories or other research and development facilities.
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MANAGEMENT
Executive Officers and Directors
The executive officers and Directors of the Company are as follows:
Name Age Position
Bjorn Nordenvall, M.D., Ph.D.(2)..... 44 Chief Executive Officer,
President and Chairman of the
Board of Directors
Claus Moller, M.D., Ph.D............. 34 Chief Medical Officer and a
Director
Ronald W. Pero, Ph.D................. 55 Chief Scientific Officer and a
Director
Marvin H. Caruthers(1)............... 56 Director
Michael Ionata(1)(2)................. 45 Director
Bo Haglund........................... 44 Chief Financial Officer
M. Andica Kunst...................... 35 Vice President and Corporate
Secretary
- ----------------------------
(1) Member of Compensation Committee
(2) Member of Audit Committee
Bjorn Nordenvall, M.D., Ph.D. was appointed as a Director in March 1995, and
became the Company's President and Chief Executive Officer in June 1995 and
Chairman of the Board of Directors in June 1996. From March to August 1996, Dr.
Nordenvall served as the Company's Chief Financial Officer. Dr. Nordenvall
serves as Chairman of the Company's Audit Committee. Dr. Nordenvall is a
specialist in general surgery and, from 1987 to September 1996, was president
of Sophiahemmet AB, a Stockholm-based hospital. During 1983 and 1984, Dr.
Nordenvall was president of Carnegie Medicine AB, Stockholm, Sweden, a
biotechnology company, and from 1977 through 1985, he practiced surgery at
Danderyd Hospital, Stockholm. From 1984 through 1986, Dr. Nordenvall served as
a consultant to Carnegie, a Swedish investment banking company, and, since
1984, he has been a consultant to Skandia Insurance Company, a Swedish
insurance company.
Claus Moller, M.D., Ph.D. was appointed as a Director in March 1995 and became
the Company's Chief Medical Officer in March 1995. Since April 1, 1994, Dr.
Moller has served as a consultant to the Company, responsible for coordinating
the Company's European clinical trials. Dr. Moller is the President and a
principal shareholder of IPC Nordic A/S, a Danish pharmaceutical consulting
firm. See "--Certain Relationships and Related Transactions." From 1989 to
1994, Dr. Moller was medical director for Synthelabo Scandinavia A/S, a Danish
pharmaceutical company, and from 1983 to 1992, he was involved in cell biology
and biomedical research at the University of Copenhagen, Denmark.
Ronald W. Pero, Ph.D. is a co-founder of OXiGENE, and has been a Director and
the Company's Chief Scientific Officer since its inception. From November 1993
to June 1995, Dr. Pero also served as President of the Company. Dr. Pero
specializes in the field of DNA repair and its relation to cancer
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treatment, and directs and coordinates the Company's research and development
efforts. Dr. Pero has been a fellow of the National Institute of Environmental
Health Sciences in Research Triangle Park, North Carolina, a director of the
Division of Biochemical Epidemiology at the Strang Cancer Prevention Center in
New York City, and currently holds faculty positions at both New York
University Medical Center and the University of Lund in Lund, Sweden, where he
is a Professor of Molecular Ecogenetics. Dr. Pero is also a member of the
American Association of Science, New York Academy of Sciences, International
Preventive Oncology Society, European Society for Therapeutic Radiation
Oncology and The American Association of Cancer Research, as well as serving as
Scientific Director of the Board of Trustees of the Swedish American Research
Foundation. Dr. Pero has published more than 175 manuscripts related to his
research.
Marvin H. Caruthers, Ph.D. was elected as a Director at the Company's 1996
Annual Meeting of Stockholders in June 1996, and serves on the Company's
Compensation Committee. Dr. Caruthers is a Professor of Chemistry and
Biochemistry at the University of Colorado, Boulder, Colorado, whose research
in nucleic acid chemistry resulted in new methods for the chemical synthesis of
DNA. Dr. Caruthers is a scientific co-founder of, and serves as a consultant
to, Amgen Inc., a biotechnology company engaged in the development of products
derived from gene synthesis capabilities, and is a scientific co-founder of
Applied Biosystems Inc., a biotechnology company engaged in the development of
DNA synthesizers and protein sequencers and a division of The Perkin-Elmer
Corporation. Dr. Caruthers also serves on the board of directors of BioStar,
Inc., a biotechnology company, and Skandigen AB, a publicly-traded Swedish
biotechnology company ("Skandigen"). Dr. Caruthers, who is a member of the
United States National Academy of Sciences and the American Academy of Arts and
Sciences, has published more than 140 manuscripts related to his research.
Michael Ionata was appointed as a Director in October 1995, and serves as
Chairman of the Company's Compensation Committee. Mr. Ionata is Director of
Corporate Finance of Nordberg Capital Inc., an investment banking firm based in
New York. From May 1983 to May 1991, Mr. Ionata worked in corporate finance and
venture capital management at Den Norske Bank, a Norwegian bank, in its New
York office. Prior to joining Den Norske Bank, Mr. Ionata worked for Coopers &
Lybrand LLP specializing in valuations, cost-benefit analysis and
restructurings. Mr. Ionata is currently a director of C.E.L. Industries Poland,
a restaurant company, and was a director of Skandigen.
Bo Haglund was appointed Chief Financial Officer in August 1996. From January
1992 to August 1996, Mr. Haglund was employed by Carnegie in various
capacities, most recently heading its London operations, focusing on the
marketing of Scandinavian and emerging market stock to U.K. investors. Prior to
joining Carnegie, from November 1990 to January 1992, Mr. Haglund was executive
vice president and chief financial officer of Swedish Exploration Consortium
AB, a Swedish publicly-traded company engaged in oil and gas exploration. From
January 1988 to October 1990, Mr. Haglund was vice president finance of Cool
Carriers AB, a shipping company, and from April 1982 to December 1987, he was
chief financial officer of Gulf Agency Group, a ship brokerage company.
M. Andica Kunst was appointed Vice President and Corporate Secretary in July
1996. Ms. Kunst is responsible for the Company's legal and administrative
affairs. Prior to joining the Company, Ms. Kunst was an attorney with the New
York City law firm of Battle Fowler LLP, the Company's outside general counsel
in the United States. Ms. Kunst holds a LL.M. in Corporate Law from New York
University School of Law, a Masters in International Affairs from The George
Washington University and degrees in Dutch and International Law from the
University of Amsterdam, Amsterdam, The Netherlands.
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Board of Directors Committees and Meetings
The Board of Directors has two standing committees: the Audit Committee
and the Compensation Committee. Currently, the Company has no Executive
Committee.
The Audit Committee reviews, with the Company's independent auditors,
the scope and timing of their audit services and any other services they are
asked to perform, the auditor's report on the Company's financial statements
following completion of their audit and the Company's policies and procedures
with respect to internal accounting and financial controls. In addition, the
Audit Committee makes annual recommendations to the Board of Directors
regarding the appointment of independent auditors for the ensuing year. The
Audit Committee currently consists of Messrs. Nordenvall (Chairman) and Ionata.
The Compensation Committee reviews and makes recommendations to the
Board of Directors regarding the salaries, benefits and bonuses of the
Company's officers. In addition, the Compensation Committee reviews and advises
on general policy matters relating to employee compensation and benefit
matters, and administers the OXiGENE 1996 Stock Incentive Plan. The
Compensation Committee currently consists of Messrs. Ionata (Chairman) and
Caruthers, the Company's two non-employee directors.
Advisors to Board of Directors
Following the Company's 1996 Annual Meeting of Stockholders in June
1996, Professor Hans Wigzell and Dr. Peter Sjostrand were appointed as advisors
to the Board of Directors. In that capacity they attend meetings of, although
they do not vote on any matters submitted to, the Board of Directors and
regularly provide expertise and advice to the Company in several areas.
Peter Sjostrand, M.D., serves on the board of directors of PharmaVision
2000 AG, a publicly-traded Swiss investment company focusing on the health care
industry, and is the chairman of the board of directors of Trygg-Hansa, a
publicly-traded Swedish insurance company. From 1975 through 1993, Dr.
Sjostrand was employed by Astra AB, a publicly-traded Swedish pharmaceutical
company, most recently as its executive vice president and chief financial
officer. In addition to a medical degree from the Karolinska Institute, Dr.
Sjostrand holds a Bachelors degree in Economics from the Stockholm School of
Economics.
Hans Wigzell, M.D., Ph.D., is Professor and Chairman of the Department
of Immunology at the Karolinska Institute, Stockholm, Sweden, a well known
medical research institute in Europe. He is a member of the Nobel Committee for
the prize in medicine, of which he recently served as chairman. Professor
Wigzell currently is a member of the editorial board of several international
medical journals and has published more than 400 articles in the areas of tumor
biology, immunology, cell biology and infectious diseases. Professor Wigzell is
also the Chairman of the Company's Scientific Advisory Board.
Scientific Advisory Board
In August 1992, the Company established a Scientific Advisory Board,
which currently consists of nine members. The Scientific Advisory Board
discusses, and meets annually to evaluate, the Company's research and
development projects. Members of the Scientific Advisory Board receive $500 per
meeting actually attended and are reimbursed for reasonable out-of-pocket
expenses. In addition, each
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member of the Scientific Advisory Board, with the exception of Dr. Berglund,
Professor Wigzell, Dr. Horsman and Dr. Chaplin, each of whom joined the
Scientific Advisory Board after its formation, has received warrants to
purchase 5,000 shares of Common Stock, at an exercise price of $1.95 per share,
expiring in May 1998, and options to purchase 2,500 shares of Common Stock, at
an exercise price of $7.25 per share, expiring in December, 2003. Prior to the
establishment of the Scientific Advisory Board, certain of its members advised
the Company on certain projects. Certain members of the Scientific Advisory
Board also have other relationships with the Company, as described below.
Dr. Berglund, who joined the Scientific Advisory Board in December
1993, received options to purchase a total of 5,000 shares of Common Stock,
exercisable at $7.25 per share, expiring in December 2003. Professor Wigzell,
who joined the Scientific Advisory Board in August 1994, received stock
appreciation rights with respect to 30,000 shares of Common Stock, at a
reference price of $7.63 per share, expiring in August 2004. These stock
appreciation rights vest in three equal annual installments on each of August
1995, 1996, and 1997. In addition, Professor Wigzell receives cash compensation
of $10,000 per annum. Dr. Horsman, who joined the Scientific Advisory Board in
November 1994, received options to purchase 5,000 shares of Common Stock,
exercisable at $5.50 per share. Dr. Chaplin, who joined the Scientific Advisory
Board in May 1995, received options to purchase 30,000 shares of Common Stock,
at an exercise price of $5.375 per share, expiring in May 2005. These options
vest in three equal annual installments on each of May 30, 1996, 1997, and
1998. In addition, Dr. Chaplin receives cash compensation of $30,000 per annum.
The members of the Company's Scientific Advisory Board are:
Hans Wigzell, M.D., Ph.D., is Chairman of the Scientific Advisory
Board. His biography is listed above under the subcaption "- Advisors to Board
of Directors."
David J. Chaplin, Ph.D., is Head of the Tumour Microcirculation Group
at the Gray Laboratory, the Mount Vernon Hospital, Middlesex, United Kingdom
and a consultant to the Company (see "Business--Research and Development and
Collaborative Arrangements"). The Gray Laboratory is a leading radiation
biology research laboratory. Dr. Chaplin has published more than 100 papers in
the area of chemical radiosensitizers and tumor biology.
Goran Berglund, M.D., Ph.D., is Professor of Medicine, Malmo General
Hospital, Vice Dean, Faculty of Medicine, Lund University, Sweden. Dr. Berglund
has published numerous articles, most recently on the biological bank and
biomarker program aspects of the Malmo Diet Study.
Michael Horsman, Ph.D., is Senior Scientist in the Danish Cancer
Societies' Department of Clinical Oncology in Aarhus, Denmark. Dr. Horsman has
published more than 100 papers on the chemical modification of radiation and
heat damage in tumors.
Myron Jacobson, Ph.D., is Professor and Chairman of the Division of
Medicinal Chemistry and Pharmaceuticals, College of Pharmacy, and a member of
the Lucille Parker Markey Cancer Center of the University of Kentucky. Dr.
Jacobson has published more than 100 papers in the area of biological responses
to DNA damage. Dr. Jacobson acts also as a consultant to the Company regarding
certain technical and clinical aspects of the Company's research and
development program (see "Business--Research and Development and Collaborative
Arrangements").
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Dick Killander, M.D., Ph.D., , is Professor and Chairman of the
Department of Oncology, University of Lund Hospital, Lund, Sweden. Dr.
Killander serves on the board of the Swedish Cancer Foundation, and has
published more than 100 articles in the areas of quantitative cytochemistry and
clinical oncology. Dr. Killander is the principal clinical investigator for the
Company's ongoing clinical trials.
Daniel G. Miller, M.D., is President of the Strang Cancer Prevention
Center, New York, New York, and has held several posts at Memorial
Sloan-Kettering Cancer Center and The New York Hospital-Cornell Medical Center
in New York, New York. Dr. Miller has been a cancer consultant to the World
Health Organization in Thailand and the Radiation Effects Research Foundation
in Hiroshima, Japan. He is the founder, and served as the first President, of
the American Society of Preventive Oncology.
Michael P. Osborne, M.D., is Director of Strang-Cornell Breast Center
and is an Attending Surgeon in the Department of Surgery at The New York
Hospital-Cornell Medical Center, both in New York, New York. Dr. Osborne has
published more than 100 articles on breast cancer.
Mark E. Smulson, Ph.D., is Professor of Biochemistry and Molecular
Biology, Georgetown University Medical Center, Washington, D.C., and heads that
University's Lombardi Cancer Center's Program of ADP-Ribosylation and DNA
Repair. Dr. Smulson has published a total of approximately 100 papers and
chapters on the molecular biology aspects of the ADPRT repair enzyme.
Executive Compensation
During the fiscal year ended December 31, 1995, the aggregate
remuneration paid to all officers and directors of the Company as a group (then
six persons) was approximately $707,000.
In May 1993, the Company entered into an employment agreement with Dr.
Pero. The agreement provides that either party may terminate the agreement upon
90 days' prior written notice. In September 1995, pursuant to the
recommendation of the Compensation Committee, Dr. Pero's annual salary was
fixed at $240,000.
In October 1995, the Company entered into an employment agreement with
Dr. Nordenvall. The initial term of the agreement expires on May 31, 1997, but
will be extended automatically for additional one-year periods unless
terminated by either party upon 90 days' prior written notice. The agreement
provides that Dr. Nordenvall's base salary shall be determined in good faith by
the Company's Board of Directors, but shall not be less than $50,000.
Currently, in light of Dr. Nordenvall devoting less than all of his time to the
Company's business and affairs, his annual base salary has been fixed at
$50,000. However, if its business and affairs would require Dr. Nordenvall to
devote more time to the Company, his base salary is expected to be adjusted
accordingly.
Currently, Drs. Moller and Pero are devoting a substantial majority of
their time to the Company's business and affairs. Dr. Nordenvall devotes such
time, but less than all of his time, to the Company's business and affairs as
is required from time to time.
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Option Holdings as of October 18, 1996
The following table sets forth, as of October 18, 1996, the number of
exercisable and unexercisable options/warrants held by each of the Company's
executive officers.
Number of Unexercised Options/Warrants at October 18, 1996
Name Exercisable Unexercisable
- ---- ----------- -------------
Bjorn Nordenvall 165,000 165,000
Claus Moller 58,333 46,667
Ronald W. Pero 260,000 0
Bo Haglund 0 30,000
M. Andica Kunst 0 30,000
Certain Relationships and Related Transactions
IPC Nordic Consulting Agreement. In August 1995, the Company entered
into a consulting agreement with IPC Nordic A/S, a company organized under the
laws of Denmark ("IPC") of which Dr. Claus Moller, a Director and the Chief
Medical Officer of the Company, is the president and a principal shareholder.
Pursuant to the agreement, IPC and Dr. Moller provide services with respect to
the Company's clinical trials and a possible future compassionate use program
in consideration of a monthly consulting fee of the equivalent of approximately
$11,900.
Omentum Consulting Agreement. In October 1995, the Company entered into
a consulting agreement with B. Omentum Consulting AB, a company organized under
the laws of Sweden ("Omentum") of which Dr. Bjorn Nordenvall, a director and
the President and Chief Executive Officer of the Company, is the sole
shareholder. Pursuant to the agreement, the Company pays Omentum an annual
consulting fee of $50,000. The initial term of the agreement expires on May 31,
1997, but will be extended automatically for additional one-year periods unless
terminated by either party upon 90 days' prior written notice.
1996 Stock Incentive Plan
General. At the 1996 Annual Meeting of Stockholders, the Company's
stockholders approved the OXiGENE 1996 Stock Incentive Plan (the "1996 Plan").
Certain directors, officers and employees of the Company and its subsidiary and
consultants and advisors thereto may be granted options to purchase shares of
Common Stock of the Company or SARs under the 1996 Plan. The number of
consultants, advisors, employees and other service providers eligible to
receive awards under the 1996 Plan is not presently determinable.
A maximum of 1,000,000 shares of Common Stock may be made the subject
of options and SARs granted under the 1996 Plan. As of October 18, 1996,
options with respect to 335,000 shares of Common Stock had been granted under
the 1996 Plan. No employee may be granted options or free-
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standing SARs with respect to more than 500,000 shares of Common Stock. That
number of shares may be adjusted in the event of certain changes in the
capitalization of the Company.
The 1996 Plan will be administered by a committee of at least two
directors (the "Committee"), each of whom will be "disinterested" within the
meaning of Rule 16b-3 promulgated under the Exchange Act, and an "outside
director" within the meaning of Section 162(m) of the Code. The Committee will
have authority, subject to the terms of the 1996 Plan, to determine when and to
whom to make grants under the plan, the number of shares to be covered by the
grants, the types and terms of options and SARs granted, the exercise price of
options and SARs and to prescribe, amend and rescind rules and regulations
relating to the 1996 Plan. Options granted to non-employee directors are
governed by the formula discussed below. Options granted under the 1996 Plan
may not be transferred to another person except by will or the laws of descent
and distribution.
Director Options. Directors who are not employees of the Company
("Non-employee Directors") were granted an option to purchase 55,000 shares of
Common Stock on the first business day following the 1996 Annual Meeting.
Thereafter, on the first business day following each successive annual meeting,
so long as shares remain available under the 1996 Plan, each Non-employee
Director who is first elected as a director at such meeting will be granted
options in respect of 55,000 shares. Each Non-employee Director will receive
options under the 1996 Plan with respect to no more than 55,000 shares of
Common Stock. The per share exercise price will be equal to the fair market
value of a share of Common Stock on the date immediately preceding the date the
option is granted. Options granted to Non-employee Directors will be
exercisable in five equal annual installments of 11,000 shares on each
anniversary of the date of grant. Options granted to Non-employee Directors
will expire 10 years from the option grant date.
Employee Options. Under the terms of the 1996 Plan, "incentive stock
options" ("ISOs") within the meaning of Section 422 of the Internal Revenue
Code of 1986, as amended (the "Code"), "nonqualified stock options" ("NQSOs")
and SARs may be granted by the Committee to employees of the Company and any of
its affiliates and to consultants and service providers to the Company or any
present or future Affiliate Corporations (as defined in the 1996 Plan) (each a
"Participant"), except that ISOs may be granted only to employees of the
Company and any of its subsidiaries. The per share purchase price (the "Option
Price") under each Option granted to a Participant will be established by the
Committee at the time the Option is granted. However, the per share Option
Price of an ISO granted to a Participant may not be less than 100% of the Fair
Market Value (as defined in the 1996 Plan) of a share on the date the ISO is
granted (110% in the case of an ISO granted to a Ten-Percent Stockholder).
Participant Options will be exercisable at such times and in such installments
as determined by the Committee. The Committee may accelerate the exercisability
of any Participant Option at any time. Each Option granted pursuant to the 1996
Plan will be for such term as determined by the Committee, provided, however,
that no Employee Option (as defined in the 1996 Plan) will be exercisable after
the expiration of ten years from its grant date (five years in the case of an
ISO granted to a Ten-Percent Stockholder).
General Requirements. Options granted pursuant to the 1996 Plan
generally may not be exercised more than three months after the option holder
ceases to provide services to the Company or an affiliate, except that in the
event of the death or permanent and total disability of the option holder, the
option may be exercised by the holder (or the holder's estate, as the case may
be), for a period of up to one year after the date of death or permanent and
total disability. The agreements evidencing the grant of an option (other than
an option to a Non-employee Director) may, in the sole and absolute discretion
of the
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Committee, set forth additional or different terms and conditions applicable to
such option upon a termination or change in status of the employment or service
of the optionee. Options terminate immediately if the option holder's service
is terminated for cause.
The shares purchased upon the exercise of an option are to be paid for
in cash or through the delivery of other shares of Common Stock with a value
equal to the total Option Price or in a combination of cash and such shares. In
addition, the option holder may have the Option Price paid by a broker or
dealer and the shares issued upon exercise of the option delivered directly to
the broker or dealer.
Stock Appreciation Rights. The Committee also may grant SARs either
alone ("Free Standing Rights") or in conjunction with all or part of an option
("Related Rights"). Upon the exercise of an SAR a holder is entitled, without
payment to the Company, to receive cash, shares of Common Stock or any
combination thereof, as determined by the Committee, in an amount equal to the
excess of the fair market value of one share of Common Stock over the exercise
price per share specified in the related option (or in the case of a Free
Standing Right, the price per share specified in such right), multiplied by the
number of shares of Common Stock in respect of which the SAR is exercised.
Amendment or Termination. The Board of Directors of the Company has the
power to terminate or amend the 1996 Plan at any time. If the Board of
Directors does not take action to earlier terminate the 1996 Plan, it will
terminate on March 11, 2006. Certain amendments may require the approval of the
Company's stockholders, and no amendment may adversely affect options that have
previously been granted.
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PRINCIPAL STOCKHOLDERS
The following table sets forth the number of shares of Common Stock
beneficially owned, as of October 18, 1996 and as adjusted to give effect to
the Offering, by (i) each holder of more than 5% of the Common Stock, as
reported the Company by such holder on reports on Schedule 13D or Schedule 13G
under the Exchange Act, (ii) each of the Company's directors and executive
officers and (iii) the directors and executive officers of the Company as a
group. Unless otherwise noted, all shares are owned directly with sole voting
and dispositive powers.
Beneficial Ownership(2)
Name(1) Percent
No. of Shares Before Offering As Adjusted
------------- --------------- -----------
Ronald W. Pero 690,000 (3) 8.72% 7.74%
Bjorn Nordenvall 380,000 (4) 4.86% 4.31%
Claus Moller 58,333 * *
Michael Ionata 5,000 (5) * *
Marvin H. Caruthers 1,500 (6) * *
Bo Haglund 0 * *
M. Andica Kunst 0 * *
Richard A. Brown 864,900 (7) 10.65% 9.48%
Invesco PLC 464,400 6.07% 5.37%
All directors and executive
officers as a group (7 persons) 1,134,833 13.93% 12.41%
- -------------------------------------
* Indicates less than one percent.
(1) Each person listed in the table is a director or executive officer of the
Company, with an address at c/o OXiGENE, Inc., 110 E. 59th Street, New
York, NY 10022, except for Richard A. Brown, whose address is 17 Prospect
Hill Road, Box 1116, Stockbridge, MA 01262; and Invesco PLC, which
address is 11 Devonshire Square, London EC2M 4YR, England.
(2) Includes the following shares which are purchasable under options and
warrants that are presently exercisable or exercisable within 60 days of
the date of this table: Dr. Pero - 260,000 shares; Dr. Nordenvall -
165,000 shares; Dr. Moller - 58,333 shares; Mr. Ionata - 5,000 shares;
and Mr. Brown 465,000 shares.
(3) Includes 70,588 shares held by a trust for the benefit of Dr. Pero's
children, and 120,588 shares held by The Ronald Pero Charitable Remainder
Unitrust, a trust of which Dr. Pero is the trustee.
(4) Includes 1,000 shares held by his spouse as to which Dr. Nordenvall
disclaims beneficial ownership; 142,700 held by a corporation organized
under the laws of Sweden of which Dr. Nordenvall is the sole stockholder;
and 71,300 shares held through a capital insurance placed by Dr.
Nordenvall.
(5) Options are held by Nordberg Capital Inc., a New York investment banking
firm, of which Mr. Ionata is Director of Corporate Finance and the
directors, officers and key employees of which own, collectively, 72,800
shares of OXiGENE Common Stock. Mr. Ionata disclaims beneficial ownership
of such shares.
(6) Includes 1,000 shares held by his spouse in trust for his children, as to
which Professor Caruthers disclaims beneficial ownership.
(7) Includes 20,000 shares held for the benefit of his minor child.
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DESCRIPTION OF SECURITIES
Introduction
On August 26, 1993, OXiGENE completed an initial public offering of
1,605,000 units, each unit consisting of one share of common stock, par value
$.01 per share ("Common Stock"), and one warrant ("Public Warrants") to
purchase an additional share of Common Stock. The Common Stock and the Public
Warrants have been traded on the Nasdaq SmallCap and upon completion of this
Offering will be traded on the Nasdaq National Market, under the symbols "OXGN"
and "OXGNW," respectively. See "Market Data."
Common Stock
The Company is authorized to issue 15,000,000 shares of Common Stock.
On October 18, 1996, 7,655,978 shares of Common Stock were outstanding. The
holders of Common Stock are entitled to one vote for each share held of record
on all matters to be voted on by stockholders. There is no cumulative voting
with respect to the election of directors. As a consequence, the holders of
more than 50% of the shares voting for the election of directors can elect all
the directors. The By-Laws provide that only a majority of the issued and
outstanding shares of Common Stock need to be represented for a quorum, and to
transact business at a stockholders' meeting. The holders of Common Stock are
entitled to receive dividends when, as and if declared by the Board of
Directors out of the funds legally available therefor. The Company has no
present plans to pay dividends with respect to the shares of Common Stock. In
the event of liquidation, dissolution or the winding up of the Company, the
holders of Common Stock are entitled to share ratably in all assets remaining
available for distribution after payment of liabilities and after provision has
been made for each class of stock, if any, having preference over the Common
Stock. Holders of shares of Common Stock, as such, have no conversion,
preemptive or other subscription rights, and there are no redemption provisions
applicable to the Common Stock. All the outstanding shares of Common Stock are,
and the Shares offered hereby when issued against payment therefor, will be,
validly authorized and issued, fully paid and nonassessable.
Public Warrants
The Public Warrants were issued pursuant to a Warrant Agreement between
the Company and American Stock Transfer & Trust Company, as a warrant agent,
and are in registered form. Currently, each of the Public Warrants entitles the
registered holder thereof to purchase 1.07 shares of Common Stock, at a price
of $12.35 per share (the "Exercise Price"), which Exercise Price shall be
increased by $2.00 on August 26, 1997. Unless exercised, the Public Warrants
will automatically expire on the close of business on August 26, 1998. On
October 18, 1996, an aggregate of 1,185,241 Public Warrants (exercisable
currently for 1,268,207 shares of Common Stock) remained outstanding.
The holders of the Public Warrants have certain anti-dilution
protection upon the occurrence of certain events, including stock dividends,
stock splits, mergers and reclassifications. The holders of the Public Warrants
have no right to vote on matters submitted to the stockholders of the Company,
have no right to receive dividends, and have none of the other rights conferred
upon stockholders of the Company. The holders of the Public Warrants are not
entitled to share in the assets of the Company in the event of liquidation,
dissolution or the winding up of the Company's affairs.
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UNDERWRITING
The Offering consists of the International Offering of 800,000 Shares
and the U.S. Offering of 200,000 Shares. The number of Shares offered in the
International and U.S. Offerings shown above are indicative amounts only. The
number of Shares actually sold in each Offering may be more or less than such
amounts.
The underwriters named below (the "Underwriters"), for whom D. Carnegie
AB ("Carnegie") and Nordberg Capital Inc. are acting as representatives (the
"Representatives"), have severally agreed, subject to the terms and conditions
of the underwriting agreement between the Company and the Underwriters (the
"Underwriting Agreement"), to purchase from the Company the number of Shares
set forth opposite their respective names below:
Underwriter Number of
Shares
--------
D. Carnegie AB............................
Nordberg Capital Inc. ....................
----------
Total............................ 1,000,000
=========
The Underwriting Agreement provides that the obligations of the
Underwriters to purchase the Shares listed above are subject to certain
conditions precedent, including the approval of certain legal matters by
counsel. The Underwriting Agreement also provides that the Underwriters are
committed to purchase all of the Shares, if any are purchased.
The Underwriters have advised the Company that they propose to offer
the Shares initially at the public offering price set forth on the cover page
of this Prospectus; provided that purchasers of Shares in the International
Offering may also be required to pay a brokerage commission of not in excess of
$_____ per share. The Underwriters may allow certain dealers a concession not
in excess of $ per share, and such dealers may reallow a concession not in
excess of $ per share to certain other dealers. After the public offering, the
offering price and other selling terms may be changed by the Representatives.
The Company has granted the Underwriters an over-allotment option,
exercisable for 30 days from the date of this Prospectus, to purchase, in the
aggregate, up to 150,000 additional shares of Common Stock at the public
offering price, less underwriting discounts and commissions, as set forth on
the cover page of the Prospectus. The Underwriters may exercise such option
solely for the purpose of covering over-allotments incurred in the sale of the
Common Stock offered hereby.
The Company has agreed, for a period of 90 days after the date of this
Prospectus, and its officers and directors, holding an aggregate of 646,500
shares of Common Stock and options and other rights to purchase up to 870,000
additional shares of Common Stock have agreed, for a period of 180 days after
the date of this Prospectus, that they will not, directly or indirectly, offer,
sell, offer to sell, contract to sell, pledge, grant any option to purchase or
otherwise sell or dispose (or announce any offer, sale, offer of sale, contract
of sale, pledge, grant of any option to purchase or other sale or disposition)
-53-
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of any shares of Common Stock or other capital stock of the Company, or any
securities convertible into, or exercisable or exchangeable for, any shares of
Common Stock or other capital stock of the Company (subject, in the case of the
Company, to certain limited exceptions), without the prior written consent of
D. Carnegie AB, on behalf of the Underwriters.
Purchasers of the Shares may be required to pay stamp taxes and other
charges, in accordance with the laws and practices of the country of purchase,
in addition to the offering price on the cover page hereof.
The Company has agreed to indemnify the several Underwriters or
contribute to losses arising out of certain liabilities, including liabilities
under the Securities Act.
Carnegie acted as placement agent in connection with the Company's
$10.0 million private placement of shares of Common Stock in July 1995. The
Company has also engaged Carnegie to render certain investment banking services
to the Company. In consideration of such services, the Company is paying
Carnegie a monthly retainer fee of approximately $15,000 and a variable
retainer fee for any special tasks performed by Carnegie. During 1995, the
Company paid Carnegie approximately $395,000.
Mr. Michael Ionata, a Director of the Company, is Director of Corporate
Finance of Nordberg Capital Inc., one of the Underwriters.
LEGAL MATTERS
The validity of the Shares has been passed upon by Battle Fowler LLP,
New York, New York, a limited liability partnership including professional
corporations. Cooper & Dunham LLP, New York, New York, has reviewed and passed
upon information of a legal nature contained under the captions "Risk
Factors--Dependence on Patents and Proprietary Technology" and
"Business--Patents and Trade Secrets." Sonnenschein Nath & Rosenthal, New York,
New York, has acted as counsel to the Underwriters.
EXPERTS
The consolidated financial statements of the Company at December 31,
1995 and 1994, and for each of the three years in the period ended December 31,
1995, appearing in OXiGENE, Inc.'s Annual Report (Form 10-K) for the year ended
December 31, 1995, have been audited by Ernst & Young LLP, independent
auditors, as set forth in their report thereon included therein and
incorporated herein by reference. Such consolidated 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.
The portions of this Prospectus entitled "Risk Factors--Dependence on
Patents and Proprietary Technology" and "Business--Patents and Trade Secrets,"
insofar as they constitute summaries of matters of law, have been reviewed and
approved by Cooper & Dunham LLP, as experts in patent law.
-54-
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GLOSSARY OF SCIENTIFIC TERMS
ADPRT Adenosine Diphosphate Ribosyl Transferase--an
enzyme involved in the DNA repair process
Anti-emetic A drug which controls nausea and vomiting
Apoptosis A natural programmed cell death not involving
cell replication
CD4 cell counts A sub-set of white blood cells directly involved
in the natural protection against diseases
CGLP standards Current good laboratory practice standards
required for regulatory affairs
Chemotherapy Drugs that control cancer growth
Cisplatin A chemotherapeutic compound
Control group A group of patients involved in a clinical trial
who are receiving placebos
Cross-over study A study in which each patient receives all
treatments singly, but at different times of the
study
Cytotoxic agent Tumor-killing agent
DNA Chemical building blocks of genetic material
Double-blind study 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
Enzyme A protein that carries out a metabolic function
by converting one substance to another
Genetic blueprint The code that tells cells what to do and how to
function
Genetic lesions Damage to the DNA or in the genetic blueprint
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i.m. Intramuscular
Immune deficiencies Suppression of the cells that fight disease within
the body
IND An "Investigational New Drug" application filed
with the U.S. Food and Drug Administration that
permits the administration of compounds to humans
in clinical trials
In vivo-exposed spleen Spleen cells are exposed in the animal then taken
and cell out for testing
i.v. Intravenous
Malignant cell Cancer cell
Metabolic function Living process of growth and reproduction
NDA A "New Drug Application" filed with the U.S.
Food and Drug Administration, which, if
approved, allows a drug to be marketed in the
U.S.
Necrosis Cell death by decomposition after replication
N-substituted benzamide Class of drugs believed by OXiGENE to
sensitize radiation and chemotherapy
Nucleotides A class of nucleic acid compounds from which
genes are constructed
Open-label clinical trial A non-blinded clinical trial
Oxidative stress Undesired natural metabolism of oxygen-derived
molecules by the body that can induce DNA
damage
Placebo A non-active substance given to a control group of
patients in a clinical trial to duplicate the
treatment method, but without the administration
of the active drug under investigation
Radiation Physical energy that splits molecules and induces
DNA damage
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Randomized clinical trial A clinical trial in which the allocation of patients
to treatment groups is made on a random basis
Sensitization The process that renders a tumor more
susceptible to damage by radiation or
chemotherapy
Serum thiol level The level of compounds in serum that react with
oxidative stress
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Appendix I
The following sets forth additional information regarding the Company's
clinical trials. This information is qualified in its entirety and should be
read in conjunction with the information contained elsewhere in this
Prospectus.
Clinical Study - Sensamide(TM) in NSCLC, Phase I/II
This open-label, historically controlled trial, assessing the safety of
Sensamide(TM) when used in combination with radiotherapy, was conducted at the
Department of Oncology, Lund University Hospital in Lund, Sweden. A total of 23
patients with inoperable squamous cell carcinoma of the lung (the most common
form of NSCLC), 21 male and 2 female, varying in age from 52 to 81 years, were
enrolled in this study. All patients were treated with a combination of
radiation and Sensamide(TM), a high-dosage form of metoclopramide,
intravenously. Radiation was administered five days per week for four to six
weeks and patients were initially followed for eighteen months thereafter.
Eighteen patients completed the study as planned. Complete or partial response,
as defined by World Health Organization criteria, was achieved in 50 percent of
the patients.
The majority of patients enrolled in this study experienced no side
effects associated with the administration of Sensamide(TM) other than those
typically experienced from anti-emetic metoclopramide therapy. The majority of
patients expressed none to mild radiation side-effects at all organ sites
evaluated, namely skin, lung, cardiac and esophageal tissues. None of the
patients had their treatment interrupted due to radiation induced side-effects.
Adverse events associated with Sensamide(TM) were mainly CNS-related
(central nervous system-related) and were comparable to those resulting from
anti-emetic metoclopramide therapy, although the patients' abilities to
complete treatment were lower. Eighteen patients (approximately 78 percent)
experienced sedation/tiredness and 11 patients (approximately 48 percent)
experienced anxiety/restlessness. Depression, insomnia and other CNS-related
reactions were experienced by seven patients. Akineton, a drug used to treat
the side effects induced by Sensamide(TM), was administered to approximately 44
percent of the patients to relieve those side effects. Five of the 23 enrolled
patients dropped out of the study due to Sensamide(TM)-associated adverse
CNS-effects. The occurrence of sedation/tiredness and the total occurrence of
Sensamide(TM)- associated adverse CNS effects were significantly greater in
patients receiving a total dose of metoclopramide greater than 2,000 mg, as
compared to patients receiving less than 2,000 mg during the whole course of
the therapy.
A preliminary assessment of the efficacy of Sensamide(TM) as adjunct
therapy to radiation in patients with NSCLC is based on the results of this
study. The assessment includes the determination of tumor response and patient
survival. Of the 23 patients involved in the study, one could not be evaluated
due to death prior to the first follow-up examination. Of the remaining
patients, complete tumor response was recorded in 9 percent of the patients,
partial tumor response in 41 percent, stable disease in 41 percent and
progressive disease in 9 percent. The mean time to local tumor progression in
these patients was 10.8 + 8.5 months. The mean and median survival time of
patients treated with Sensamide(TM) plus radiation was approximately 15.3
months and 12.8 months, respectively. The Company believes that this survival
time is longer than that reported in the literature for patients with severe
NSCLC who received radiation only. The total and weekly doses of Sensamide(TM)
received with the combined radiation/Sensamide(TM) treatment significantly
related to mean survival time. Complete or partial responders who had a mean
survival time of 18.5 + 3.4 months (mean + standard error) received an
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average total dose of 2,273 + 543 mg (mean + standard deviation) of
Sensamide(TM). In contrast, non-responders who received an average total dose
of 1,820 + 291 mg (mean + standard deviation) of Sensamide(TM) had a mean
survival time of 9.9 + 1.9 months (mean + standard deviation).
The results of this Phase I/II clinical trial indicate that the safety
of Sensamide(TM), when given in combination with radiation therapy and
administered in accordance with the Company's prescribed regimens, are
comparable to its use in other clinical indications. These results were
published in the December 1995 edition of The European Journal of Cancer.
Clinical Study - Sensamide(TM) in NSCLC, Phase II/III
This study was initiated by OXiGENE in the middle of 1994. Currently,
centers in Norway, Denmark, Sweden, Germany and the United Kingdom (the "U.K.")
participate in this study. The purpose of this Phase II/III 15 center,
randomized, controlled trial is to assess the safety, tolerance and efficacy of
Sensamide(TM) (2 mg/kg of body weight i.v., delivered one hour prior to
radiation) as adjunct treatment to radiation as compared to radiation only in
the treatment of 226 patients with NSCLC. Patients receive radiation five times
per week and Sensamide(TM) three times per week for six and one half weeks. As
of October 14, 1996, approximately 185 patients have been recruited. At the
current recruitment rate, the Company expects to have the results of this study
available in the third quarter of 1997.
Clinical Study - Sensamide(TM) i.v., Neu-Sensamide(TM) i.m./i.v., Phase I
The primary objective of this randomized, placebo, double blind
cross-over study, conducted at Guilford Clinical Pharmacology Unit in the U.K.,
was to assess the safety of single, doses (2 mg/kg of body weight) of
Neu-Sensamide(TM) when administered as an i.m. injection or as an i.v. infusion
compared with an i.v. dose of Sensamide(TM) or an i.m. placebo injection. The
secondary objective was to compare the pharmacokinetics of Neu-Sensamide(TM)
when administered as a single i.m. injection or i.v. infusion with that of i.v.
infused Sensamide(TM).
The difference between Neu-Sensamide(TM) and Sensamide(TM) is a changed
formulation, resulting in two different forms of metoclopramide. Thus,
Sensamide(TM) is acidic (pH of around 2.5-3.8) like any traditional
metoclopramide suspension whereas Neu-Sensamide(TM) is phosphate buffered and
neutralized with a pH of around 6.7.
Eleven healthy male volunteers, varying in age from 53 to 63 years,
completed the study. The results revealed that Neu-Sensamide(TM) i.m. exhibits
equivalent bioavailability to Sensamide(TM) i.v. However, Sensamide(TM) i.v.
had more CNS-related effects than Neu-Sensamide(TM), both i.v. and i.m. In
addition, adverse effects were less frequent and of shorter duration with
Neu-Sensamide(TM), both i.v. and i.m., than with Sensamide(TM) i.v.
Bioavailability of Neu-Sensamide(TM) i.m. was comparable to that of Neu-
Sensamide(TM) i v. and Sensamide(TM) i.v. Local tolerability of Neu-
Sensamide(TM) i.m. was comparable to that of placebo i.m.
Nineteen healthy male volunteers participated in this study. One was
withdrawn due to non-compliance with the protocol, 7 volunteers dropped out due
to adverse effects, and 11 volunteers completed the study. During the 53
treatment sequences of those patients that completed the study, a total of 93
adverse effects were reported; 37 after Sensamide(TM) i.v., 24 after
Neu-Sensamide(TM) i.v., 25 after Neu-Sensamide(TM) i.m., and 7 after the
placebo. No unexpected adverse effects associated with either
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Sensamide(TM) or Neu-Sensamide(TM) occurred throughout the study. Thus, adverse
effects occurred significantly less frequently in volunteers receiving
Neu-Sensamide(TM) than in those receiving Sensamide(TM).
No differences in pharmacokinetics could be detected in the study,
apart from, as expected, in the peak plasma concentration between Neu-
Sensamide(TM) i.m. and Sensamide(TM)/Neu- Sensamide(TM) i.v.
Clinical Study - Neu-Sensamide(TM) in NSCLC, Phase III
This Phase III study has been planned on the basis of the results of
the Phase I study described above, and is based on the design of the ongoing,
controlled Phase II/III with Sensamide(TM) in NSCLC. This randomized,
multi-center, controlled Phase III study will assess the safety, tolerance and
efficacy of Neu-Sensamide(TM) as a radiosensitizing agent compared to
radiotherapy only for the treatment of NSCLC. Patients who satisfy the
inclusion criteria and who are appropriate for treatment with 60 Gray
radiation, the most commonly administered form of radiotherapy for NSCLC, will
be enrolled into the study. Patients will be randomized to receive either
radiotherapy only or radiation plus Neu-Sensamide(TM) (2 mg/kg of body weight
i.m.).
The study is expected to start in the fourth quarter of 1996 and will
involve a total of approximately 20 European and United States oncology
centers. Patients will undergo a 45-day treatment period. Adverse effects,
vital signs and laboratory values will be monitored periodically for safety
evaluation. During the post-treatment follow-up period, patients will be
followed for 18 months. The primary efficacy parameters will be duration of
tumor response and patient survival.
Clinical Study - Neu-Sensamide(TM) in Glioblastomas, Phase I/II
This study will assess the safety and tolerability of Neu-Sensamide(TM)
as a radiosensitizing agent in patients receiving a six-week treatment of 54
Gray of radiotherapy, the most commonly administered form of radiotherapy for
glioblastoma, following operative biopsy, subtotal or macroscopical total
excision of their glioblastoma multiforme. The study is designed as a
single-center, open-label, dose escalation study. The patients will be assigned
in a consecutive manner to receive escalating doses of Neu-Sensamide(TM) from 2
to 8 mg/kg of body weight i.m . All patients will receive their study
medication one hour prior to the administration of each fraction of
radiotherapy. A total of up to 15 consecutive patients will be recruited.
Patients will be treated in groups of three with increasing doses of
Neu-Sensamide(TM). The post-treatment review of the patients will be conducted
at weeks 4, 8, 12, 24, 36 and 48. Patient enrollment commenced in August 1996
and will continue into 1997.
The primary safety parameter will be the incidence of signs and
symptoms of CNS-related toxicity, such as neurological reactions, psychological
reactions, restlessness/insomnia, sedation and convulsions. Secondary
parameters will include the incidence of other adverse effects and significant
laboratory value changes during and after treatment. In addition, tumor
response and patient survival evaluations will be performed. If the results of
this study so warrant, OXiGENE intends to initiate a larger controlled Phase
III study in patients with glioblastomas.
Clinical Study - Oxi-104, Phase I
The Company currently anticipates commencing a Phase I clinical test of
Oxi-104 after the intended filing of an IND 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.
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Non-GLP (non-Good Laboratory Practices) toxicology studies have
indicated the safety of Oxi-104 in animal studies in doses five to ten times
higher than the intended maximum doses needed for obtaining optimal anti-cancer
effects. In vivo and in vitro animal studies have demonstrated that Oxi-104 can
sensitize and induce a one to eight fold increase in the effect of established
chemotherapeutic agents such as cisplatin, gemcitabine, bleomycin, ara-C and
melphalan.
General
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 gain market acceptance. See "Risk Factors - Early Stage of
Product Development; Uncertainty of Clinical Trials; Unproven Safety and
Efficacy."
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<PAGE>
Report of Independent Auditors
The Board of Directors and Stockholders
OXiGENE, Inc.
We have audited the accompanying consolidated balance sheets of OXiGENE, Inc.
(the "Company") (a development stage company) as of December 31, 1995 and 1994,
and the related consolidated statements of operations, stockholders' equity
(deficit), and cash flows for each of the three years in the period ended
December 31, 1995. These financial statements are the responsibility of the
Company's management. Our responsibility is to express an opinion on these
financial statements based on our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audits to
obtain reasonable assurance about whether the financial statements are free of
material misstatement. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a reasonable basis
for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the consolidated financial position of OXiGENE, Inc. (a
development stage company) at December 31, 1995 and 1994, and the consolidated
results of its operations and its cash flows for each of the three years in the
period ended December 31, 1995 in conformity with generally accepted accounting
principles.
ERNST & YOUNG LLP
New York, New York
February 27, 1996
F-2
<PAGE>
<TABLE>
<CAPTION>
OXiGENE, Inc.
(A development stage company)
Consolidated Balance Sheets
December 31
1994 1995
-------------------------------------------
<S> <C> <C>
Assets
Current assets:
Cash and cash equivalents $ 1,193,999 $ 10,406,605
Securities available-for-sale (Note 2) 3,291,128 502,020
Prepaid expenses 207,967 50,180
Interest receivable 44,955 202,164
Other - 19,132
-------------------------------------------
Total current assets 4,738,049 11,180,101
Furniture, fixtures and equipment, at cost 33,598 62,087
Accumulated depreciation 10,296 24,537
-------------------------------------------
23,302 37,550
Deposits 9,600 9,600
-------------------------------------------
Total assets $ 4,770,951 $ 11,227,251
===========================================
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued expenses:
Due to CATO Research, Ltd. (Note 6) $ 122,109 $ 133,734
Accrued expenses 45,900 259,301
Accrued stock appreciation rights - 223,095
Other payables 122,960 53,947
-------------------------------------------
Total current liabilities 290,969 670,077
Commitments (Note 5)
Stockholders' equity (Note 3):
Common stock, $.01 par value:
Authorized shares--
10,000,000 shares at December 31, 1994
15,000,000 shares at December 31, 1995
Issued and outstanding shares--
5,058,100 shares at December 31, 1994
6,823,300 shares at December 31, 1995 50,581 68,233
Common stock subscribed - 50
Additional paid-in capital 12,188,565 21,864,364
Deficit accumulated during the development stage (7,682,039) (11,399,874)
Foreign currency translation adjustment - 24,894
Unrealized losses on securities available-for-sale (77,125) (493)
-------------------------------------------
Total stockholders' equity 4,479,982 10,557,174
-------------------------------------------
Total liabilities and stockholders' equity $ 4,770,951 $ 11,227,251
===========================================
See accompanying notes.
</TABLE>
F-3
<PAGE>
<TABLE>
OXiGENE, Inc.
(A development stage company)
Consolidated Statements of Operations
<CAPTION>
Period from
February 22, 1988
(inception) through
Year ended December 31 December 31,
1993 1994 1995 1995
----------------------------------------------------------------------
(Unaudited)
<S> <C> <C> <C> <C>
Revenues
Research income $ - $ - $ - $ 31,000
Interest income 50,897 265,440 420,949 747,241
----------------------------------------------------------------------
50,897 265,440 420,949 778,241
Operating expenses
Research and development:
CATO Research, Ltd. (Note 6) 468,083 608,337 739,994 2,465,223
Other 411,112 1,156,125 2,103,599 4,604,537
----------------------------------------------------------------------
Total research and development 879,195 1,764,462 2,843,593 7,069,760
General and administrative 1,191,714 1,340,737 1,295,191 5,108,355
----------------------------------------------------------------------
Total operating expenses 2,070,909 3,105,199 4,138,784 12,178,115
----------------------------------------------------------------------
Net loss $ (2,020,012) $ (2,839,759) $ (3,717,835) $ (11,399,874)
======================================================================
Net loss per common share $ (0.50) $ (.56) $ (.63)
Weighted average number of
common shares outstanding 4,026,456 5,037,278 5,876,295
</TABLE>
See accompanying notes.
F-4
<PAGE>
OXiGENE, Inc.
(A development stage company)
Statements of Stockholders' Equity (Deficit)
(Note 2)
<TABLE>
<CAPTION>
Deficit
Accumulated
Common Stock, Additional During the
$.01 Par Value Common Stock Subscribed Paid-In Development
Date Shares Amounts Shares Amount Capital Stage
-------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C> <C>
Issuance of common stock in exchange
for transfer of patent application
ownership to the Company by an
officer/director recorded at no
value, which reflects transferor's
basis (unaudited) May 1988 380,000 $3,800 - $ - $ (3,800) $ -
Issuance of common stock at
approximately $0.74 per share
(unaudited) June 1988 271,033 2,710 - - 197,290 -
Issuance of common stock in exchange
for the outstanding common stock of
Bio-Screen Inc. (unaudited) August 1988 100,000 1,000 - - (1,000) -
Net loss for period from February 22,
1988 (inception) through December
31, 1988 (unaudited) - - - - - (185,962)
---------------------------------------------------------------------------
Balance at December 31, 1988 (unaudited) 751,033 7,510 - - 192,490 (185,962)
Issuance of common stock at
approximately $0.74 per share
(unaudited) January 1989 271,033 2,710 - - 197,290 -
Net loss for 1989 (unaudited) - - - - - (179,119)
---------------------------------------------------------------------------
Balance at December 31, 1989 (unaudited) 1,022,066 10,220 - - 389,780 (365,081)
Issuance of common stock at March 1990 to
approximately $0.74 per share December 1990 257,487 2,575 - - 187,425 -
Common stock subscribed December 1990 - - 13,547 10,000 - -
Net loss for 1990 - - - - - (326,648)
---------------------------------------------------------------------------
Balance at December 31, 1990 1,279,553 12,795 13,547 10,000 577,205 (691,729)
Issuance of common stock at
approximately $0.74 per share January 1991 13,547 136 (13,547) (10,000) 9,864 -
Issuance of common stock at $0.71 per
share February 1991 330,000 3,300 - - 230,033 -
Issuance of common stock at
approximately $1.50 per share August 1991 100,000 1,000 - - 149,000 -
Issuance of common stock at $1.95 per
share December 1991 220,000 2,200 - - 426,800 -
Net loss for 1991 - - - - - (501,872)
---------------------------------------------------------------------------
Balance at December 31, 1991 1,943,100 19,431 - - 1,392,902 (1,193,601)
Issuance of common stock at $1.95 per
share, net of issuance costs of
approximately $121,000 December 1992 985,000 9,850 - - 1,789,866 -
Net loss for 1992 - - - - - (1,628,667)
---------------------------------------------------------------------------
Balance at December 31, 1992 2,928,100 29,281 - - 3,182,768 (2,822,268)
</TABLE>
<TABLE>
<CAPTION>
Unrealized
Foreign Stock Losses on Total
Currency Subscription Securities Stockholders'
Translation and Notes Available for Equity
Date Adjustment Receivable Sale (Deficit)
-------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
Issuance of common stock in exchange
for transfer of patent application
ownership to the Company by an
officer/director recorded at no
value, which reflects transferor's
basis (unaudited) May 1988 $ - $ - $ - $ -
Issuance of common stock at
approximately $0.74 per share
(unaudited) June 1988 - - - 200,000
Issuance of common stock in exchange
for the outstanding common stock of -
Bio-Screen Inc. (unaudited) August 1988 - - -
Net loss for period from February 22,
1988 (inception) through December -
31, 1988 (unaudited) - - (185,962)
----------------------------------------------------------
Balance at December 31, 1988 (unaudited) - - - 14,038
Issuance of common stock at
approximately $0.74 per share
(unaudited) January 1989 - - - 200,000
Net loss for 1989 (unaudited) - - - (179,119)
----------------------------------------------------------
Balance at December 31, 1989 (unaudited) - - - 34,919
Issuance of common stock at March 1990 to
approximately $0.74 per share December 1990 - - - 190,000
Common stock subscribed December 1990 - (10,000) - -
Net loss for 1990 - - - (326,648)
----------------------------------------------------------
Balance at December 31, 1990 - (10,000) - (101,729)
Issuance of common stock at
approximately $0.74 per share January 1991 - 10,000 - 10,000
Issuance of common stock at $0.71 per
share February 1991 - - - 233,333
Issuance of common stock at
approximately $1.50 per share August 1991 - - - 150,000
Issuance of common stock at $1.95 per
share December 1991 - - - 429,000
Net loss for 1991 - - - (501,872)
----------------------------------------------------------
Balance at December 31, 1991 - - - 218,732
Issuance of common stock at $1.95 per
share, net of issuance costs of
approximately $121,000 December 1992 - (360,750) - 1,438,966
Net loss for 1992 - - - (1,628,667)
----------------------------------------------------------
Balance at December 31, 1992 - (360,750) - 29,031
</TABLE>
F-5
<PAGE>
OXiGENE, Inc.
(A development stage company)
Statements of Stockholders' Equity (Deficit) (continued)
(Note 2)
<TABLE>
<CAPTION>
Deficit
Accumulated
Common Stock, Additional During the
$.01 Par Value Common Stock Subscribed Paid-In Development
Date Shares Amounts Shares Amount Capital Stage
-------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C> <C>
Issuance of common stock at $1.95 per
share, net of issuance costs of January 1993 to
approximately $136,500 February 1993 445,000 $4,450 - $ - $ 726,800 $ -
Repayment of notes receivable January 1993 - - - - - -
Issuance of warrants and options as
compensation to certain directors to
purchase 180,000 and 10,000 shares
of common stock, respectively, at
$1.95 per share May 1993 - - - - 427,500 -
Issuance of common stock at $6.00 per
share, net of issuance costs of
approximately $1,836,000 September 1993 1,500,000 15,000 - - 7,149,247 -
Issuance of common stock at $6.00 per
share, net of issuance costs of
approximately $82,000 October 1993 105,000 1,050 - - 547,050 -
Net loss for 1993 - - - - - (2,020,012)
---------------------------------------------------------------------------
Balance at December 31, 1993 4,978,100 49,781 - - 12,033,365 (4,842,280)
Issuance of common stock at $1.95 per
share April 1994 80,000 800 - - 155,200 -
Net loss for 1994 - - - - - (2,839,759)
Unrealized losses on securities
available-for-sale - - - - - -
---------------------------------------------------------------------------
Balance at December 31, 1994 5,058,100 50,581 - - 12,188,565 (7,682,039)
Issuance of options as compensation
to consultants to purchase 165,000
shares of common stock at $6.00
per share June 1995 - - - - 20,625 -
Issuance of common stock at $6.00
per share, net of issuance costs
of approximately $524,000 July 1995 1,666,700 16,667 - - 9,460,009 -
Issuance of common stock at $1.50
per share (12,500) and $1.95 per July 1995 to
share (86,000) December 1995 98,500 985 - - 185,465 -
Subscriptions for 5,000 shares of
common stock at $1.95 per share December 1995 - - 5,000 50 9,700 -
Foreign currency translation
adjustment for 1995 - - - - - -
Net loss for 1995 - - - - - (3,717,835)
Unrealized gain on securities
available-for-sale - - - - - -
---------------------------------------------------------------------------
Balance at December 31, 1995 6,823,300 $68,233 5,000 $ 50 $21,864,364 $(11,399,874)
===========================================================================
</TABLE>
<TABLE>
<CAPTION>
Unrealized
Foreign Stock Losses on Total
Currency Subscription Securities Stockholders'
Translation and Notes Available For Equity
Date Adjustment Receivable Sale (Deficit)
-------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
Issuance of common stock at $1.95 per
share, net of issuance costs of January 1993 to
approximately $136,500 February 1993 $ $ - $ - $ 731,250
-
Repayment of notes receivable January 1993 - 360,750 - 360,750
Issuance of warrants and options as
compensation to certain directors to
purchase 180,000 and 10,000 shares
of common stock, respectively, at
$1.95 per share May 1993 - - - 427,500
Issuance of common stock at $6.00 per
share, net of issuance costs of
approximately $1,836,000 September 1993 - - - 7,164,247
Issuance of common stock at $6.00 per
share, net of issuance costs of
approximately $82,000 October 1993 - - - 548,100
Net loss for 1993 - - - (2,020,012)
----------------------------------------------------------
Balance at December 31, 1993 - - - 7,240,866
Issuance of common stock at $1.95 per
share April 1994 - - - 156,000
Net loss for 1994 - - - (2,839,759)
Unrealized losses on securities
available-for-sale - - (77,125) (77,125)
----------------------------------------------------------
Balance at December 31, 1994 - - (77,125) 4,479,982
Issuance of options as compensation
to consultants to purchase 165,000
shares of common stock at $6.00
per share June 1995 - - - 20,625
Issuance of common stock at $6.00
per share, net of issuance costs
of approximately $524,000 July 1995 - - - 9,476,676
Issuance of common stock at $1.50
per share (12,500) and $1.95 per July 1995 to
share (86,000) December 1995 - - - 186,450
Subscriptions for 5,000 shares of
common stock at $1.95 per share December 1995 - - - 9,750
Foreign currency translation
adjustment for 1995 24,894 - - 24,894
Net loss for 1995 - - - (3,717,835)
Unrealized gain on securities
available-for-sale - - 76,632 76,632
----------------------------------------------------------
Balance at December 31, 1995 $ 24,894 $ - $ (493) $10,557,174
==========================================================
</TABLE>
See accompanying notes.
F-6
<PAGE>
<TABLE>
<CAPTION>
OXiGENE, Inc.
(A development stage company)
Consolidated Statements of Cash Flows
Period from
February 22, 1988
Year ended December 31 (inception) through
December 31
1993 1994 1995 1995
----------------------------------------------------------------------
(Unaudited)
<S> <C> <C> <C> <C>
Operating activities
Net loss $ (2,020,012) $ (2,839,759) $ (3,717,835) $(11,399,874)
Adjustments to reconcile net loss to
net cash used in operating
activities:
Loss on securities available-for-
sale - - 9,460 9,460
Depreciation 3,808 5,044 13,773 24,069
Compensation related to issuance
of warrants, options and stock
appreciation rights 427,500 - 243,720 671,220
Changes in operating assets and
liabilities:
Prepaid expenses and other
current assets (294) (252,628) (14,740) (267,662)
Accounts payable and accrued
expenses 146,657 (19,001) 146,248 437,217
-----------------------------------------------------------------------
Net cash used in operating activities (1,442,341) (3,106,344) (3,319,374) (10,525,570)
Financing activities
Proceeds from investor - - - 100,000
Repayment to investor - - - (100,000)
Proceeds from issuance and
subscription of common stock, net 8,804,347 156,000 9,672,876 21,484,522
-----------------------------------------------------------------------
Net cash provided by financing
activities 8,804,347 156,000 9,672,876 21,484,522
Investing activities
Purchases of securities available-
for-sale - (3,368,253) - (3,368,253)
Proceeds from sale of securities
available-for-sale 2,856,280 2,856,280
Deposits - - - (9,600)
Purchase of furniture, fixtures and
equipment (9,713) (4,345) (26,922) (60,520)
-----------------------------------------------------------------------
Net cash (used in) provided by
investing activities (9,713) (3,372,598) 2,829,358 (582,093)
Effect of exchange rate on changes in
cash - - 29,746 29,746
-----------------------------------------------------------------------
Net (decrease) increase in cash and
cash equivalents 7,352,293 (6,322,942) 9,212,606 10,406,605
Cash and cash equivalents at
beginning of period 164,648 7,516,941 1,193,999 -
-----------------------------------------------------------------------
</TABLE>
F-7
<PAGE>
<TABLE>
<CAPTION>
Period from
February 22, 1988
Year ended December 31 (inception) through
December 31
1993 1994 1995 1995
----------------------------------------------------------------------
(Unaudited)
<S> <C> <C> <C> <C>
Cash and cash equivalents at
end of period $ 7,516,941 $ 1,193,999 $ 10,406,605 $10,406,605
=======================================================================
See accompanying notes.
</TABLE>
F-8
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements
December 31, 1995
1. Description of Business and Significant Accounting Policies
Description of Business
OXiGENE, Inc. (the "Company") is a development stage pharmaceutical company.
The Company was originally incorporated as Oxi-Gene, Inc. in the State of New
York on February 22, 1988 and subsequently recapitalized and incorporated in
the State of Delaware in December 1992.
The Company is in the research phase of its operations. Because operations
to-date have consisted of research activities only, no substantial income has
been generated to-date and the losses sustained result principally from outlays
for research and administrative expenses. The Company will need to obtain
additional funds from outside sources to fund operating expenses, pursue
regulatory approvals and build production, sales and marketing capabilities, as
necessary.
Principles of Consolidation
In December 1994, the Company established a wholly-owned subsidiary in Sweden,
OXiGENE (Europe) AB to manage and control the Company's research and
development work, and monitor European clinical trials. The accounts of the
subsidiary have been consolidated from the time the subsidiary commenced
operations in January 1995. All material intercompany balances and transactions
have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reported period.
Actual results could differ from those estimates.
F-9
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
1. Description of Business and Significant Accounting Policies (continued)
Depreciation
Furniture, fixtures and equipment are recorded at cost. Depreciation is
provided using the straight-line method over the estimated useful lives of the
assets which is principally seven years.
Cash and Cash Equivalents
The Company considers all highly liquid financial instruments with a maturity
of three months or less when purchased to be cash equivalents.
Substantially all cash and cash equivalents are deposited in one financial
institution at December 31, 1995. Substantially all cash and cash equivalents
were deposited in another financial institution at December 31, 1994.
Foreign Currency Translation
Assets and liabilities of the subsidiary are translated at year-end rates and
income and expenses are translated at average exchange rates prevailing during
the year. Translation adjustments arising from differences in exchange rates
from period to period are included in the accumulated foreign currency
translation adjustments account in stockholders' equity.
Investments
The Company accounts for marketable securities in accordance with the
provisions of Statement of Financial Accounting Standards No. 115, "Accounting
for Certain Investments in Debt and Equity Securities."
Management determines the appropriate classification of debt securities at the
time of purchase and reevaluates such designation as of each balance sheet
date. Debt securities are classified as held-to-maturity when the Company has
the positive intent and ability to hold the securities to maturity.
F-10
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
1. Description of Business and Significant Accounting Policies (continued)
Investments (continued)
Debt securities not classified as held-to-maturity are classified as
available-for-sale. Available-for-sale securities are stated at fair value,
with the unrealized gains and losses reported in a separate component of
shareholders' equity.
The amortized cost of debt securities classified as held-to-maturity or
available-for-sale is adjusted for amortization or premiums and accretion of
discounts to maturity. Such amortization is included in interest income from
investments. Realized gains and losses, and declines in value judged to be
other-than-temporary are included in net securities gains (losses). The cost of
securities sold is based on the specific identification method.
Patent and Patent Applications
The Company has filed applications for patents in connection with technologies
being developed. The patent applications and any patents issued as a result of
these applications are important to the protection of the Company's
technologies that may result from its research and development efforts. The
pharmaceutical industry is highly competitive and patents may be challenged
from time to time. The Company intends to vigorously defend its issued patents
and may therefore incur significant costs in the defense of the patents and
related technologies. Costs associated with the patent and patent applications
are expensed as incurred.
Income Taxes
The Company accounts for income taxes based upon the provisions of Statement of
Financial Accounting Standards No. 109, "Accounting for Income Taxes" ("SFAS
109"). Under SFAS 109, the liability method is used for accounting for income
taxes, and deferred tax assets and liabilities are determined based on
differences between financial reporting and tax bases of assets and liabilities.
F-11
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
1. Description of Business and Significant Accounting Policies (continued)
Share Information
All outstanding share amounts included in the accompanying financial statements
have been adjusted to reflect the 10,000 for 1 stock split disclosed in Note 3.
Unaudited Information
Information pertaining to the period from February 22, 1988 (inception) through
December 31, 1989 is unaudited.
Net Loss Per Share
Net loss per share is based upon net loss divided by weighted average number of
shares of common stock outstanding during the respective periods, retroactively
adjusted to reflect the stock split. The weighted average number of common
shares outstanding has been computed in accordance with Staff Accounting
Bulletin 83 ("SAB 83") of the Securities and Exchange Commission. SAB 83
requires that shares of common stock and warrants, issued within a one-year
period prior to the initial filing of a registration statement relating to an
initial public offering at amounts substantially below the public offering
price, be considered outstanding for all periods presented in the Company's
Registration Statement. During the one-year period preceding the effectiveness
of the Company's registration statement in August 1993, the Company issued
1,290,000 shares of common stock at $1.95 per share and warrants to purchase
387,500 shares of common stock exercisable at $1.95 per share. Accordingly, for
purposes of calculating loss per share amounts, such shares have been
considered outstanding for all periods presented, and such warrants have been
considered outstanding through June 30, 1993. For purposes of calculating net
loss per share, the initial offering price was assumed to be $6 per share (see
Note 3). All other options and warrants were antidilutive and, accordingly,
excluded from the calculation of weighted average shares.
F-12
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
1. Description of Business and Significant Accounting Policies (continued)
Stock-Based Compensation
In October 1995, the Financial Accounting Standards Board (FASB) issued
Statement of Financial Accounting Standards No. 123, "Accounting for
Stock-Based Compensation" ("SFAS 123"). SFAS 123 is effective for fiscal years
beginning after December 31, 1995 and prescribes accounting and reporting
standards for all stock-based compensation plans, including employee stock
options, restricted stock, employee stock purchase plans and stock appreciation
rights. SFAS 123 requires compensation expense to be recorded (i) using the new
fair value method or (ii) using existing accounting rules prescribed by
Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to
Employees" ("APB 25") and related interpretations with pro forma disclosure of
what net income and earnings per share would have been had the Company adopted
the new fair value method. The Company presently accounts for its stock based
compensation plans in accordance with the provisions of APB 25 and has not
determined if it intends to change to the fair value method prescribed in SFAS
123.
2. Investments
The following is a summary of securities available-for-sale:
<TABLE>
<CAPTION>
Securities Available-for-Sale
--------------------------------------------------------
Gross Estimated
Unrealized Fair
Cost Losses Value
------------------------------------------------------
<S> <C> <C> <C>
December 31, 1994
U.S. Government securities:
U.S Treasury Notes $ 1,342,644 $ 31,546 $ 1,311,098
Student Loan Marketing
Association 1,001,256 22,256 979,000
------------------------------------------------------
2,343,900 53,802 2,290,098
------------------------------------------------------
U.S. corporate debt securities:
American Express Credit
Corporation 522,893 14,938 507,955
Ford Motor Credit Company 501,460 8,385 493,075
------------------------------------------------------
1,024,353 23,323 1,001,030
------------------------------------------------------
$ 3,368,253 $ 77,125 $ 3,291,128
======================================================
</TABLE>
F-13
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
2. Investments (continued)
<TABLE>
<S> <C> <C> <C>
December 31, 1995
U.S. corporate debt securities:
American Express Credit
Corporation $ 502,513 $ 493 $ 502,020
------------------------------------------------------
$ 502,513 $ 493 $ 502,020
======================================================
</TABLE>
The amortized cost and estimated fair value of debt securities at December 31,
1995, by contractual maturity are shown below.
Cost Fair Value
-------------------------------------
Available-for-Sale
Due in one year or less $ 502,513 $ 502,020
=====================================
3. Stockholders' Equity
Options and Warrants
The following is a summary of the Company's stock option and warrant activity.
<TABLE>
<CAPTION>
Stock
Nonqualified Stock Incentive Appreciation Stock
Stock Options Options Rights Warrants
---------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
Balance at December 31, 1992 12,500 240,000 - 506,000
Granted during 1993 197,500 125,000 22,500 2,056,500
---------------------------------------------------------------------------------
Balance at December 31, 1993 210,000 365,000 22,500 2,562,500
Granted during 1994 - - 52,500 -
Exercised during 1994 - (80,000) - -
Canceled during 1994 - (160,000) - -
---------------------------------------------------------------------------------
Balance at December 31, 1994 210,000 125,000 75,000 2,562,500
Granted during 1995 669,000 - 2,000 -
Exercised during 1995 (12,500) - - (86,000)
Canceled during 1995 (2,000) - - -
---------------------------------------------------------------------------------
Balance at December 31, 1995 864,500 125,000 77,000 2,476,500
=================================================================================
</TABLE>
F-14
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
3. Stockholders' Equity (continued)
Nonqualified Stock Options
In August 1991, the Company's Board of Directors granted options to a former
officer of the Company to purchase 12,500 shares of the Company's common stock
at $1.50 per share exercisable at any time prior to August 7, 2001. During
1995, such options to purchase 12,500 shares of the Company's common stock were
exercised.
In December 1993, under the Amended Plan, as defined below, the Company's Board
of Directors granted options to certain directors of the Company and other
individuals to purchase 197,500 shares of the Company's common stock at $7.25
per share. Such options vested at various dates over a period of one year from
the date of grant and are exercisable at any time prior to December 13, 2003.
In November 1994, under the Amended Plan, the Company's Board of Directors
granted options, subsequently approved by stockholders in May 1995, to certain
director's of the Company and other individuals to purchase 252,000 shares of
the Company's common stock at market value ($5.59 per share). Such options vest
at various dates over a period of 28 months from the date of grant.
In 1995, under the Amended Plan, the Company's Board of Directors granted to
certain directors of the Company and other individuals options to purchase
417,000 shares of the Company's common stock at exercise prices ranging from
$5.375 per share to $7.00 per share. Options to purchase 252,000 shares were
granted at exercise prices equal to the market value of the shares on date of
grant. The remaining 165,000 shares are exercisable at $6.00 per share. Because
the market price of the Company's shares amounted to $6.125 per share on the
date these options were granted, the Company recorded a charge for financial
reporting purposes of approximately $20,625.
F-15
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
3. Stockholders' Equity (continued)
Stock Incentive Options
During 1992, the Board of Directors implemented an Stock Incentive Option Plan
(the "Plan"). The Plan provided for the grant of options to purchase up to
250,000 shares of common stock to any officer, director and employee of the
Company upon the terms and conditions (including price, exercise date and
number of shares) determined by the Board of Directors or a committee selected
by the Board of Directors to administer the Plan.
In April 1992, under the Plan, the Company's Board of Directors granted stock
options to an officer of the Company for the purchase of 240,000 shares of the
Company's common stock at $1.95 per share. Such options vest at 80,000 per year
for a three-year period. During 1994, vested options to purchase 80,000 shares
of the Company's common stock were exercised. The remaining nonvested options
to purchase 160,000 shares of the Company's common stock were cancelled upon
the termination of the officer's services in 1994.
On May 15, 1993, under the Plan, the Board of Directors granted options as
compensation to certain directors of the Company, to purchase 10,000 shares of
common stock at $1.95 per share, exercisable at any time for a period of five
years.
During May 1993, the Company amended and restated its Stock Incentive Plan (the
"Amended Plan"). Under the Amended Plan, the Company has reserved for issuance
an additional 416,900 shares of Common Stock. The Amended Plan provides for the
issuance of stock appreciation rights.
Under the Amended Plan, the exercise price determined by the Board of Directors
or committee must be at least 100% of the fair market value of the Company's
common stock as of the date of the grant. Upon termination of employment, any
granted option, vested or unvested, shall, to the extent not previously
exercised, terminate except under certain conditions as outlined in the Amended
Plan. The options granted under the Amended Plan are generally exercisable at
specific dates over a ten-year period.
F-16
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
3. Stockholders' Equity (continued)
In December 1993, under the Amended Plan, the Company's Board of Directors
granted stock options to a certain director of the Company to purchase 115,000
shares of common stock at $8.00 per share. Such options vested in equal
installments on December 14, 1993 and 1994.
Stock Appreciation Rights
Under the Amended Plan, the Company's Board of Directors granted stock
appreciation rights to 22,500 shares of common stock at an exercise price of
$7.25 per share and stock appreciation rights to another 22,500 shares at an
exercise price of $5.875 per share to an employee, certain consultants and
clinical investigators on December 14, 1993 and April 4, 1994, respectively.
Such stock appreciation rights vested in equal installments on December 14,
1994 and 1995.
In September 1994, under the Amended Plan, a member of the scientific advisory
board received stock appreciation rights to 30,000 shares of common stock at
$7.63 per share. Such stock appreciation rights vest in equal installments in
September 1994, 1995 and 1996.
In July 1995, under the Amended Plan, a consultant received stock appreciation
rights to 2,000 shares of common stock at $5.38 per share. Such stock
appreciation rights vest in equal installments on July 13, 1995 and July 13,
1996.
On December 31, 1995, the market value per share of common stock ($10.25)
exceeded the exercise price of the stock appreciation rights and, accordingly,
the Company recorded a charge for financial reporting purposes of approximately
$223,000.
Stock Warrants
In November 1991, and January and June 1992, the Board of Directors granted
warrants to directors of the Company to purchase 50,000, 370,000 and 50,000
shares, respectively, of the Company's common stock at $1.95 per share
exercisable at any time for a period of five years. In connection with the sale
of stock during December 1992, the placement agents were granted warrants to
purchase 36,000 shares of the Company's stock at $1.95
F-17
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
3. Stockholders' Equity (continued)
Stock Warrants (continued)
per share exercisable for a five-year period. During 1995, warrants to purchase
86,000 shares of the Company's common stock were exercised. In addition, as of
December 31, 1995, $9,750 was subscribed to exercise warrants to purchase 5,000
shares of common stock. Such shares were issued in 1996.
From January 1, 1993 through February 26, 1993, the Company sold 445,000 shares
of common stock to investors for approximately $868,000 ($1.95 per share). In
connection with this issuance of stock, the placement agents were granted
warrants for the purchase of 66,500 shares of the Company's common stock at
$1.95 per share exercisable for a five-year period.
In January 1993, the Board of Directors granted warrants to the Company's
scientific advisory board to purchase 45,000 shares of the Company's common
stock at $1.95 per share exercisable at any time for a period of five years.
On May 15, 1993, the Board of Directors granted warrants as compensation to
certain directors of the Company, to purchase 180,000 shares of common stock at
$1.95 per share exercisable at any time for a period of five years. The Company
has recorded a charge of $427,500 for financial reporting purposes,
representing the estimated value of such options and warrants granted on May
15, 1993.
During 1993, the Company completed an initial public offering of 1,500,000
units at $6.00 per unit and an over-allotment issuance of 105,000 units at
$6.00 per unit. Each unit consists of one share of the Company's common stock
and one warrant. Each warrant is exercisable for one share of the Company's
common stock at a price of $7 per share during the first year of
exercisability. Thereafter, the exercise price shall increase each year by
$2.00 ($11 at December 31, 1995). On January 26, 1996, the exercise price of
these warrants were reduced to $10.35 per share and the number of shares
purchasable upon exercise of each warrant was increased to 1.07 (warrants to
purchase 1,717,350 shares at $10.35 per share). In connection with this
offering, the Company sold to the Underwriters, for nominal consideration,
150,000 Warrants (the "Underwriters'
F-18
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
3. Stockholders' Equity (continued)
Warrants"). The Underwriters' Warrants are initially exercisable at a price of
$9.90 per Unit for a period of four years, commencing August 26, 1994. The
shares of common stock and warrants issuable upon the exercise of the
Underwriters' Warrants are identical to those included in the Units offered in
the initial public offering except that the Warrants contained in the
Underwriters' Warrants are initially exercisable to purchase one share of
Common Stock at $11.55.
On December 14, 1993, the Board of Directors granted warrants to certain
individuals of the Company to purchase 10,000 shares of common stock at $7.25
per share. Such warrants vested immediately.
Private Placement
In July 1995, the Company completed a private placement of 1,666,700 common
shares at $6.00 per share, resulting in net proceeds (after deducting issuance
costs) of approximately $9.5 million.
Common Stock Reserved for Issuance
As of December 31, 1995, the Company has reserved approximately 3,845,000
shares of its common stock for issuance in connection with stock options and
warrants.
Recapitalization
During December 1992, in connection with the recapitalization (see Note 1), the
Company changed its authorized common stock from 1,000 shares at $1.00 par
value to 5,000,000 shares at $.01 par value. In addition, the Company declared
a 10,000 for 1 stock split on the then issued and outstanding common shares.
In April 1993, the Company changed its authorized common stock from 5,000,000
shares at $.01 par value to 10,000,000 shares at $.01 par value.
In May 1995, the Company changed its authorized common stock from 10,000,000
shares at $.01 par value to 15,000,000 shares at $.01 par value.
F-19
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
3. Stockholders' Equity (continued)
Merger
During February 1991, the Company issued 100,000 shares of its common stock to
an officer/director and a director for all the outstanding common stock of
Bio-Screen, Inc. The balance sheet and the cumulative results of operations of
Bio-Screen, Inc. were not material to the Company and, consequently, the
statements of operations of the Company have not been restated. The issuance of
the 100,000 shares, which have been recorded at par value, has been reflected
as of August 1988, the date of inception of Bio-Screen, Inc.
(see Note 5 "Commitments").
4. Income Taxes
Effective January 1, 1992, the Company changed its method of accounting for
income taxes from the deferred method to the liability method required by
Statement No. 109, "Accounting for Income Taxes" (see Note 1 "Significant
Accounting Policies"). As permitted under the new rules, prior years' financial
statements have not been restated. There was no cumulative effect on the
Company's financial statements as a result of adopting Statement No. 109.
At December 31, 1995, the Company had net operating loss carryforwards of
approximately $10,672,000 for U. S. and foreign income tax purposes, $8,838,000
expiring for U.S. purposes through 2010. For financial statement reporting
purposes, a valuation allowance has been recognized to offset entirely the
deferred tax assets related to the Company's net operating loss carryforwards
and the temporary difference related to compensatory stock options and
warrants.
Components of the Company's deferred tax asset at December 31, 1994 and 1995
are as follows:
1994 1995
---------------------------------
Net operating loss carryforwards $ 2,880,000 $ 3,957,000
Compensatory stock options and warrants 171,000 268,000
---------------------------------
Total deferred tax asset 3,051,000 4,225,000
Valuation allowance (3,051,000) (4,225,000)
---------------------------------
Net deferred tax asset $ - $ -
=================================
F-20
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
4. Income Taxes (continued)
The change in valuation allowance amounted to approximately $802,000 and
$1,120,000, respectively, for the years ended December 31, 1993 and 1994.
Changes in stock ownership (see Note 3) may result in a limitation on the
annual utilization of net operating loss carryforwards.
5. Commitments and Contingencies
The Company subleases its office space at its facilities in New York . During
1995, the Company entered into a new lease for office space in Lund, Sweden.
Rent expense for years ended December 31, 1993, 1994 and 1995 was approximately
$53,000, $58,000 and $50,000, respectively.
The minimum annual rent commitments for the above leases are as follows:
1996 $ 55,400
1997 14,400
1998 1,200
--------------------------
$ 71,000
==========================
In connection with the merger with Bio-Screen, Inc. (see Note 3), the Company
obtained a license agreement to patent rights to a certain product. The
agreement requires the Company to pay royalties, as defined, based on revenues
received by the Company in respect to the specified product. The license
expires in October 2011. The product has not yet been commercially developed.
From time to time the Company may be a party to litigation arising out of the
normal course of its business. The Company is and will continue to vigorously
defend the actions and claims against it. In the opinion of management, these
claims are either without merit or, based in part on opinions from legal
counsel, will not have a material adverse effect on the Company's financial
position.
F-21
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements (continued)
6. Related Party Transaction
In September 1991, the Company entered into an agreement with CATO Research,
Ltd. ("CATO"), a North Carolina corporation, which is majority-owned by Dr.
Cato, a member of the Company's Scientific Advisory Board, pursuant to which
CATO performs preclinical and clinical planning, development and regulatory
services in connection with the Company's efforts to obtain FDA approval for
its technology. CATO is compensated by the Company on an hourly basis for
services actually rendered. For the years ended December 31, 1993, 1994 and
1995, the Company incurred costs under this agreement totaling $468,083,
$608,337 and $739,994, respectively.
7. Foreign Operations
Summary financial information for assets, liabilities at December 31, 1995 and
expenses for the year ended December 31, 1995 for OXiGENE (Europe) AB are as
follows:
Assets $ 240,000
Liabilities 178,000
Expenses 1,853,000
Foreign exchange gains for the year ended December 31, 1995 were not
significant.
F-22
<PAGE>
OXiGENE, Inc.
(A development stage company)
Consolidated Balance Sheets
(All amounts in thousands of dollars, except share data)
(Unaudited)
<TABLE>
<CAPTION>
June 30, 1996
-------------
<S> <C>
Assets
Current assets:
Cash and cash equivalents $ 10,710
Securities available-for-sale --
Prepaid expenses 80
Interest receivable 77
Other 21
-------------------------
Total current assets 10,888
-------------------------
Furniture, fixtures and equipment at cost 73
Accumulated depreciation (31)
-------------------------
42
-------------------------
Deposits 10
-------------------------
Total assets $ 10,940
=========================
Liabilities and stockholders' equity:
Current liabilities:
Accounts payable and accrued expenses:
Due to Cato Research, Ltd. $ 75
Other payables 748
-------------------------
Total current liabilities 823
-------------------------
Stockholders' equity:
Common stock $0.01 par value:
Authorized shares - 15,000,000 shares
Issued and outstanding
7,271,282 at June 30, 1996 72
Additional paid-in capital 24,853
Common stock subscribed 98
Subscription receivable (98)
Deficit accumulated during the development stage (14,811)
Foreign currency translation adjustment 3
-------------------------
Total stockholders' equity 10,117
-------------------------
Total liabilities and stockholders' equity $ 10,940
=========================
</TABLE>
See accompanying notes.
F-23
<PAGE>
OXiGENE, Inc.
(A development stage company)
Consolidated Statements of Operations
(All amounts in thousands of dollars, except share data)
(Unaudited)
<TABLE>
<CAPTION>
Period from
February 22, 1988
Six Months Ended (inception)
----------------------------------------- through
June 30, 1995 June 30, 1996 June 30, 1996
------------- ------------- ------------------
<S> <C> <C> <C>
Revenue
Research Income $ - $ - $ 31
Interest income 82 254 1,001
Operating expenses:
Research and development:
Cato Research, Ltd. 282 388 2,853
Other 991 1,968 6,572
----------------------- ------------------------ -----------------------
Total research and development 1,273 2,356 9,425
General and administrative 646 1,309 6,418
----------------------- ------------------------ -----------------------
Total operating expenses 1,919 3,665 15,843
----------------------- ------------------------ -----------------------
Net loss $ (1,837) $ (3,411) $ (14,811)
======================= ======================== =======================
Net loss per common share $ (0.36) $ (.49)
======================= ========================
Weighted average number of common
shares outstanding 5,058 6,971
======================= ========================
</TABLE>
See accompanying notes.
F-24
<PAGE>
OXiGENE, Inc.
(A development stage company)
Consolidated Statements of Cash Flows
(All amounts in thousands of dollars)
(Unaudited)
<TABLE>
<CAPTION>
Period from
February 22, 1988
Six Months Ended (inception)
------------------------------------ through
June 30, 1995 June 30, 1996 June 30, 1996
------------- ------------- ------------------
<S> <C> <C> <C>
Operating activities
Net loss $ (1,837) $ (3,411) $ (14,811)
Adjustment to reconcile net loss to net cash
used in operating activities:
Depreciation 4 6 30
Amortization of debt securities 9 -- 9
Compensation related to issuance of warrants
options and stock appreciation rights -- 1,008 1,679
Changes in operating assets and liabilities:
Prepaid expenses and other current assets 138 93 (175)
Accounts payable and accrued expenses (52) 375 813
------------------- ------------------- -------------------
Net cash used in operating activities (1,738) (1,929) (12,455)
------------------- ------------------- -------------------
Financing activities
Proceeds from issuance of common stock, net -- 1,710 23,195
Other capital contributions -- 53 53
------------------- ------------------- -------------------
Net cash provided by financing activities -- 1,763 23,248
Investing activities
Proceeds from sale of securities available-for-sale 848 502 3,358
Purchase of securities available for sale -- -- (3,368)
Deposits -- -- (10)
Purchase of furniture, fixture and equipment` (18) (11) (71)
------------------- ------------------- -------------------
Net cash used in investing activities 830 491 (91)
Effect of exchange rate on changes in cash -- (22) 8
------------------- ------------------- -------------------
Net increase (decrease) in cash and cash
equivalents (908) 303 10,710
Cash and cash equivalents at beginning of period 1,194 10,407 --
------------------- ------------------- -------------------
Cash and cash equivalents at end of period $ 286 $ 10,710 $ 10,710
=================== =================== ===================
</TABLE>
See accompanying notes.
F-25
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements
June 30, 1996
Note l. Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in
accordance with generally accepted accounting principles for interim financial
information and Article 10 of Regulation S-X. Accordingly, they do not include
all of the information and footnotes required by generally accepted accounting
principles for complete financial statements. In the opinion of management, all
adjustments (consisting of normal recurring accruals) considered necessary for
a fair presentation have been included. Operating results for the six-month
period ended June 30, 1996 are not necessarily indicative of the results that
may be expected for the year ending December 31, 1996. For further information,
refer to the consolidated financial statements and footnotes thereto for the
year ended December 31, 1995.
Cash and Cash Equivalents
The Company considers all highly liquid financial instruments with a maturity
of three months or less when purchased to be cash equivalents.
Net Loss Per Share
Net loss per share is based upon the Company's aggregate net loss divided by
the weighted average number of shares of common stock outstanding during the
respective periods. All options and warrants were antidilutive and,
accordingly, excluded from the calculation of weighted average shares.
Note 2. Principles of Consolidation
At the end of 1994, the Company established a wholly-owned operating subsidiary
in Sweden, OXiGENE (Europe) AB. This subsidiary manages and controls the
Company's research and development work, and monitors the European clinical
trials. The consolidated financial statements include the accounts of the
Company and OXiGENE (Europe) AB, effective January 1, 1995.
Intercompany balances and transactions have been eliminated.
F-26
<PAGE>
OXiGENE, Inc.
(A development stage company)
Notes to Consolidated Financial Statements
June 30, 1996
Note 3. Stockholders' Equity
During the six months ended June 30, 1996, the company issued 447,982 shares of
common stock upon exercise of previously granted options resulting in proceeds
of approximately $1,710,000.
During the six months ended June 30, 1996, the Company recorded a charge for
financial reporting purposes of approximately $1,008,000 because the market
value of the Company's common stock ($25.50 at June 30, 1996) exceeded the
exercise prices of stock appreciation rights issued by the Company. Because
stock appreciation rights are satisfied, upon exercise, only by the
distribution of shares of common stock of the Company, the charge was credited
to additional paid-in capital. In addition, stock appreciation rights accrued
as a liability as of December 31, 1995 amounting to approximately $223,000,
which will not be paid in cash, was credited to additional paid-in capital
during the six months ended June 30, 1996.
F-27
<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, 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......................................... 2
PROSPECTUS SUMMARY................................................. 5
SUMMARY OF SELECTED FINANCIAL INFORMATION.......................... 8
RISK FACTORS....................................................... 9
MARKET DATA........................................................ 15
USE OF PROCEEDS.................................................... 16
CAPITALIZATION..................................................... 18
DILUTION........................................................... 19
DIVIDEND POLICY.................................................... 19
SELECTED FINANCIAL INFORMATION..................................... 20
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS..................................... 22
BUSINESS........................................................... 25
MANAGEMENT......................................................... 43
PRINCIPAL STOCKHOLDERS............................................. 51
400608.11
<PAGE>
DESCRIPTION OF SECURITIES......................................... 52
UNDERWRITING...................................................... 53
LEGAL MATTERS..................................................... 54
EXPERTS........................................................... 54
GLOSSARY OF SCIENTIFIC TERMS...................................... 55
APPENDIX.......................................................... A-1
400608.11
<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 being registered are estimated as
follows:
Amount
- -------
SEC Filing Fee.................................................... $9,914
NASD Filing Fee................................................... 3,181
Nasdaq Listing Fee................................................ 25,000
Stockholm Stock Exchange Listing Fee.............................. 45,000
Legal Fees and Expenses*.......................................... 225,000
Accounting Fees*.................................................. 40,000
Printing and Translation Expenses*................................ 100,000
Miscellaneous..................................................... 1,905
Total............................................................. $450,000
=======
- -------------
* 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 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, with respect to any criminal
action or proceeding, 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 in connection therewith.
II-1
400608.11
<PAGE>
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 breach 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 (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's 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.
II-2
400608.11
<PAGE>
Item 16. Exhibits.
1* Form of Underwriting Agreement
5* Legal Opinion of Battle Fowler LLP
10.1** Form of Indemnification Agreement between the Company and its
directors, executive officers and key employees
23.1 Consent of Ernst & Young LLP, New York, New York
23.2* Consent of Battle Fowler LLP (included in Exhibit 5)
23.3* Consent of Cooper & Dunham LLP
24.1** Power of Attorney (included herein on the signature page)
99.1** U.S. Patent Number 5,204,241, issued April 20, 1994, registered to
Ronald W. Pero, regarding glutathione-s-transferase Mu as a measure
of drug resistance
99.2** U.S. Patent Number 5,340,565, issued August 23, 1994, registered to
Ronald W. Pero, regarding tumor or cancer cell killing therapy and
agents useful therefor
99.3** U.S. Patent Number 5,482,833, issued January 9, 1996, registered to
Ronald W. Pero and Daniel G. Miller, regarding a test to determine
the predisposition or susceptibility to DNA-associated diseases
99.4** International Application Published under the Patent Cooperation
Treaty (PCT) Number WO96/14565, published May 17, 1996, registered to
Ronald W. Pero, regarding a method of testing immune competency
* To be filed by amendment.
** 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
II-3
400608.11
<PAGE>
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 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.
II-4
400608.11
<PAGE>
(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.
II-5
400608.11
<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 October 22, 1996.
OXiGENE, INC.
By:/s/ Bjorn Nordenvall
-----------------------
Bjorn Nordenvall
President and Chief Executive Officer
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 October 22, 1996
- ----------------------------------------------- Officer and Chairman of the
Bjorn Nordenvall Board of Directors (Principal
Executive Officer)
/s/ Bo Haglund Chief Financial Officer October 22, 1996
- ----------------------------------------------- (Principal Financial Officer and
Bo Haglund Principal Accounting Officer)
* Director October 22, 1996
- -----------------------------------------------
Michael Ionata
* Director October 22, 1996
- -----------------------------------------------
Marvin H. Caruthers
* Chief Medical Officer and October 22, 1996
- ----------------------------------------------- Director
Claus Moller
* Chief Scientific Officer and October 22, 1996
- ----------------------------------------------- Director
Ronald Pero
</TABLE>
*By: /s/ Bo Haglund
------------------
as Attorney-in-fact
<PAGE>
EXHIBIT INDEX
Exhibit
Number Description
1* Form of Underwriting Agreement
5* Legal Opinion of Battle Fowler LLP
10.1** Form of Indemnification Agreement between the Company
and its directors, executive officers and key employees
23.1 Consent of Ernst & Young LLP, New York, New York
23.2* Consent of Battle Fowler LLP (included in Exhibit 5)
23.3* Consent of Cooper & Dunham LLP
24.1** Power of Attorney (included herein on the signature page)
99.1** U.S. Patent Number 5,204,241, issued April 20, 1994,
registered to Ronald W. Pero, regarding glutathione-s-
transferase Mu as a measure of drug resistance
U.S. Patent Number 5,340,565, issued August 23, 1994,
99.2** registered to Ronald W. Pero, regarding tumor or cancer
cell killing therapy and agents useful therefor
99.3** U.S. Patent Number 5,482,833, issued January 9, 1996,
registered to Ronald W. Pero and Daniel G. Miller,
regarding a test to determine the predisposition or
susceptibility to DNA-associated diseases
99.4** International Application Published under the Patent
Cooperation Treaty (PCT) Number WO96/14565,
published May 17, 1996, registered to Ronald W. Pero,
regarding a method of testing immune competency
- ----------------
* To be filed by amendment.
** Previously filed.
Consent of Independent Auditors
We consent to the reference to our firm under the captions "Selected Financial
Information" and "Experts" in Amendment No. 1 to the Registration Statement
(Form S-3 No. 333-12867) and related Prospectus of OXiGENE, Inc. for the
registration of 1,000,000 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) for the year ended December 31, 1995, filed with the
Securities and Exchange Commission.
ERNST & YOUNG LLP
New York, New York
October 21, 1996
417166.1
