As filed with the Securities and Exchange Commission on August 30, 1995.
Registration No. 33-61087
================================================================================
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
OXIS INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 94-1620407
(State or other jurisdiction of (I.R.S. Employer Identification Number)
incorporation or organization)
6040 N. CUTTER CIRCLE, SUITE 317
PORTLAND, OREGON 97217-3935
(503) 283-3911
(Address, including zip code, and telephone number, including area code, of
Registrant's principal executive offices)
RAY R. ROGERS
CHAIRMAN OF THE BOARD
OXIS INTERNATIONAL, INC.
6040 N. CUTTER CIRCLE, SUITE 317
PORTLAND, OREGON 97217-3935
(503) 283-3911
(Name, address, including zip code and telephone number, including area code of
agent for service)
COPIES TO:
RICHARD SCUDELLARI, ESQ.
JACKSON, TUFTS, COLE & BLACK
60 SOUTH MARKET STREET
SAN JOSE, CALIFORNIA 95113
(408) 998-1952
Approximate date of commencement of proposed sale to the public:
As soon as practicable after the Registration Statement becomes effective.
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, check the following box.[x]
CALCULATION OF REGISTRATION FEE
Proposed Maximum Proposed Maximum
Title of Securities Amount to be Offering Price Aggregate Amount of
to be Registered Registered Per Share (1) Offering Price (1) Registration Fee
===============================================================================================================================
Common Stock $.50 par value.. 5,075,073 (2) $3.00 $15,225,219 $5,250(3)
===============================================================================================================================
(1) Estimated solely for the purpose of calculating the amount of the
registration fee pursuant to Rule 457 based on the average of the bid and
asked prices for the Common Stock, as reported by prices on the Nasdaq
National Market on July 11, 1995.
(2) Includes 472,763 shares issuable upon the exercise of warrants and 128,918
shares issuable upon the exercise of stock options
(3) $5,250 was previously paid.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE
OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT
SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF
THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a),
MAY DETERMINE.
1
PROSPECTUS
OXIS INTERNATIONAL, INC.
5,075,073 SHARES
COMMON STOCK
________________
This Prospectus relates to 5,075,073 shares of Common Stock, par value $.50
(the "Common Stock"), of OXIS International, Inc. ("OXIS" or the "Company")
which are being offered and sold by certain stockholders of the Company (the
"Selling Stockholders"), including an aggregate of 128,918 shares issuable upon
exercise of options and an aggregate of 472,763 shares issuable upon exercise of
warrants. The foregoing options have an exercise price of $3.55 per share for an
aggregate exercise price for all options of $457,658.90. Of the foregoing
warrants, warrants to purchase an aggregate of 350,000 shares of Common Stock
are exercisable for $2.875 per share (an aggregate of $1,006,250), and warrants
for the purchase of 122,763 shares are exercisable for $2.89 per share (an
aggregate of $354,785.07). The Selling Stockholders, directly or through agents,
broker-dealers or underwriters, may sell the Common Stock offered hereby from
time to time on terms to be determined at the time of sale, in transactions on
the Nasdaq National Market or in privately negotiated transactions. The Selling
Stockholders and any agents, broker-dealers or underwriters that participate in
the distribution of the Common Stock may be deemed to be "underwriters" within
the meaning of the Securities Act of 1933, as amended (the "Act"), and any
commission received by them and any profit on the resale of the Common Stock
purchased by them may be deemed to be underwriting discounts or commissions
under the Act. See "Selling Stockholders" and "Plan of Distribution." The
Company will not receive any proceeds from the sale of shares by the Selling
Stockholders.
The Common Stock of the Company is quoted on the Nasdaq National Market
under the symbol "OXIS." The last reported sales price of the Company's Common
Stock on the Nasdaq National Market on August 28, 1995 was $2-7/8 per share.
_______________________
THE SHARES OF COMMON STOCK OFFERED HEREBY INVOLVE
A HIGH DEGREE OF RISK. SEE "RISK FACTORS"
AT PAGE EIGHT OF THIS PROSPECTUS.
___________________________
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.
No underwriting commissions or discounts will be paid by the Company in
connection with this offering. Estimated expenses payable by the Company in
connection with this offering are $52,000. See "Plan of Distribution." The
aggregate proceeds to the Selling Stockholders from the Common Stock will be the
purchase price of the Common Stock sold less the
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aggregate agents' commissions and underwriters' discounts, if any. The aggregate
proceeds to the Company from the Common Stock, if any, will be the exercise
price for the options and warrants to purchase Common Stock offered hereunder, a
maximum of $1,818,693.97 in the aggregate assuming the exercise of all such
options and warrants.
The Company has agreed to indemnify the Selling Stockholders and certain
other persons against certain liabilities, including liabilities under the Act.
The date of this Prospectus is August 30, 1995
3
AVAILABLE INFORMATION
The Company is subject to the reporting requirements of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), and in
accordance therewith, files annual and quarterly reports, proxy
statements and other information with the Securities and Exchange
Commission (the "Commission"). Such reports, proxy statements and other
information may be inspected and copied at the Commission's Regional
Offices at 7 World Trade Center, 13th Floor, New York, New York 10048;
and 500 West Madison Street, Suite 1400, Chicago, Illinois 60661-2511.
Copies of such material can be obtained at prescribed rates from the
Public Reference Section of the Commission at 450 Fifth Street, N.W.,
Washington, D.C. 20549. The Common Stock of the Company is quoted on the
Nasdaq National Market. Reports and other information concerning the
Company may be inspected at the National Association of Securities
Dealers, Inc. at 1735 K Street, N.W., Washington, D.C. 20006.
No dealer, salesman or other person has been authorized to give any
information or to make any representations other than those contained in
this Prospectus, and, if given or made, such other information or
representations must not be relied upon as having been authorized by the
Company. This Prospectus does not constitute an offer or solicitation by
anyone in any state in which such offer or solicitation is not
authorized, or in which the person making such offer or solicitation is
not qualified to do so, or to any person to whom it is unlawful to make
such offer or solicitation. The delivery of this Prospectus at any time
does not imply that information herein is correct as of any time
subsequent to the date hereof.
ADDITIONAL INFORMATION
A registration statement on Form S-3 with respect to the Common
Stock offered hereby (the "Registration Statement") has been filed with
the Commission under the Act. This Prospectus does not contain all of
the information contained in such Registration Statement and the exhibits
and schedules thereto, certain portions of which have been omitted
pursuant to the rules and regulations of the Commission. For further
information with respect to the Company and the Common Stock offered
hereby, reference is made to the Registration Statement and the exhibits
and schedules thereto. Statements contained in this Prospectus regarding
the contents of any contract or any other document are not necessarily
complete and, in each instance, reference is hereby made to the copy of
such contract or document filed as an exhibit to the Registration
Statement. The Registration Statement, including exhibits thereto, may
be inspected without charge at the Commission's principal office in
Washington, D.C., and copies of all or any part thereof may be obtained
from the Public Reference Section, Securities and Exchange Commission,
Washington, D.C., 20549, upon payment of the prescribed fees.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents, filed or to be filed with the Commission
under the Exchange Act are hereby incorporated by reference into this
Prospectus:
(i) The Company's Annual Report on Form 10-K for the fiscal year
ended December 31, 1994, as amended, including all material
incorporated by reference therein.
(ii) The Company's Quarterly Report on Form 10-Q for the quarterly
period ended March 31, 1995.
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(iii) The Company's Report on Form 10-C filed on May 24, 1995.
(iv) The Company's Current Report on Form 8-K as filed on May 24,
1995.
(v) The Company's Quarterly Report on Form 10-Q for the quarterly
period ended June 30, 1995.
(vi) The Company's Current Report on Form 8-K as filed on August 3,
1995.
(vii) The description of the Registrant's Common Stock contained in
the Company's Prospectus dated June 18, 1969 (File No.
0361150) filed pursuant to Section 12 of the Exchange Act on
June 23, 1969.
All documents filed by the Company pursuant to Sections 13(a),
13(c), 14 ,or 15(d) of the Exchange Act after the date of this Prospectus
and prior to the termination of the offering shall be deemed to be
incorporated by reference herein and to be a part hereof from the date of
filing of such documents. Any statement contained in this Prospectus or
in a document incorporated or deemed to be incorporated by reference
herein shall be deemed to be modified or superseded for purposes of this
Prospectus to the extent that a statement contained herein or in any
subsequently-filed document which also is or is deemed to be incorporated
by reference herein 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.
The Company will provide without charge to each person, including
any beneficial owner, to whom this Prospectus is delivered, upon written
or oral request of such person, a copy of any and all of the documents
that have been incorporated by reference herein (not including exhibits
to such documents unless such exhibits are specifically incorporated by
reference herein or into such documents). Such request may be directed
to OXIS International, Inc., 6040 N. Cutter Circle, Suite 317, Portland,
OR 97217-3935, telephone (503) 283-3911, Attn: Jon S. Pitcher, Chief
Financial Officer.
5
THE COMPANY
The Company was initially incorporated in 1965 as Diagnostic Data,
Inc., a California corporation. It was reincorporated in Delaware in
1974, and adopted the name DDI Pharmaceuticals, Inc. in 1985. In
September, 1994, the Company acquired Bioxytech S.A., based in France
("Bioxytech"), and merged with International BioClinical, Inc. ("IBC"),
an Oregon corporation (the "Combination"), and changed its name to OXIS
International, Inc. Bioxytech was acquired through an exchange of shares
that resulted in the Company owning in excess of 99% of the outstanding
stock of Bioxytech, which operates as a subsidiary of the Company.
OXIS is engaged in the discovery, development, manufacture and
marketing of products to diagnose, treat and prevent the pathologic
effects of free radicals (i.e., diseases of oxidative stress). Free
radicals are highly reactive molecules that are damaging to cells when
their concentration exceeds the body's antioxidant defense capacity.
Oxidative stress is now thought to be a basic mechanism of cell damage
and death in a number of acute and chronic diseases such as
atherosclerosis, AIDS, cancer, diabetes, arthritis and traumatic injury.
Concomitantly, advances in molecular biology are beginning to clarify the
mechanism(s) of cellular damage by free radicals and driving market
demand for new products to diagnose, treat and prevent diseases of
oxidative stress. The Company sells or has under development assays for
markers of oxidative stress and therapeutic drug monitoring ("TDM" )
assays. In addition, the Company has programs in progress for developing
two forms of the free radical scavenging enzyme, superoxide dismutase
("SOD"), a number of synthetic antioxidant molecules designed for
targeting specific tissues, and a proprietary high molecular weight
poly(ethylene) glycol ("PEG") technology to enhance desired
pharmacological properties of SOD and other protein molecules. The
Company's staff consists of approximately 70 managers, scientists,
technicians and administrative personnel who are currently located at
four sites.
Effective July 19, 1995, the Company consummated the acquisition of
Therox Pharmaceuticals, Inc., a Delaware corporation ("Therox") by merger
of Therox into the newly-formed OXIS Acquisition Corporation, a Delaware
corporation and a wholly-owned subsidiary of OXIS ("OXIS Acquisition
Corporation") such that Therox was the disappearing corporation and OXIS
Acquisition Corporation continued as a wholly-owned subsidiary of the
Company. Therox was a Philadelphia-based free radical therapeutics
company funded by S.R. One, Limited, the venture capital subsidiary of
SmithKline Beecham, and Brantley Venture Partners II, L.P. This
transaction brings OXIS complementary technologies, seven patents, and
corporate and university partnerships in exchange for 1,440,736 shares of
OXIS Common Stock. The per share closing price of OXIS common stock on
July 19, 1995 was $3-3/8. Former Therox shareholders may earn up to an
additional $2,000,000 based on the successful commercialization of the
former Therox technologies. Pursuant to the terms of the acquisition
transaction, S.R. One, Limited and Brantley Venture Partners II, L.P.
simultaneously invested an additional $1,500,000 in cash for an aggregate
of 642,583 shares of OXIS Series B Preferred Stock. The holders of
Series B Preferred Stock are entitled to certain dividend and liquidation
preferences and have the right to elect one member of the Company's board
of directors. The acquisition of Therox will be treated as a purchase
for accounting purposes.
6
The Company's principal executive offices are located at 6040 N. Cutter
Circle, Suite 317, Portland, OR 97217-3935. Research and development
operations of OXIS are located at 518 Logue Avenue, Mountain View, CA
94043; 395 Phoenixville Pike, Malvern, PA 19355; and Z.A. des Petits
Carreaux, 2 av. des Coquellcots, F 94385 Bonneull-Sur-Marne, Cedex,
France (outside of Paris).
7
RISK FACTORS
The following are the significant risk factors that should be
considered carefully in evaluating the Common Stock of OXIS.
NEED FOR ADDITIONAL FINANCING.
The Company has incurred losses in four of the last five years and
in the six months ended June 30, 1995. As of June 30, 1995, the Company
had an accumulated deficit of approximately $20,358,000.
In May 1995, the Company sold 1,227,625 shares of Common Stock in a
private placement to offshore investors for aggregate consideration of
$2,037,860. In conjunction with the acquisition by the Company of
Therox, certain former affiliates of Therox have invested $1,500,000 in a
private placement of the Company's Series B Preferred Stock.
The Company has engaged an investment banking firm on a best-efforts
basis to assist it in completing a private placement of equity
securities. The Company is seeking to raise up to $5,000,000 in such
private placement. OXIS cannot predict the timing or the probability of
success of this effort, and no assurances can be given that the Company
will successfully raise the needed capital or that the terms of such
financing will be favorable to the Company. If the Company is unable to
raise additional capital during the remainder of 1995, it intends to
curtail its operations through the reduction of personnel and facility
costs and by slowing its research and development efforts. If the
Company were unable to sufficiently curtail its costs in such a
situation, it might be forced to seek protection of the courts through
reorganization, bankruptcy or insolvency proceedings. Assuming that the
Company successfully completes its private placement of equity
securities, it is anticipated that further financing may be needed within
approximately 24 months to allow the Company to continue its planned
research and development programs and marketing of additional products.
The unavailability of such financing could cause the Company to cease or
curtail its operations, and/or delay or prevent the development and
marketing of the Company's potential therapeutic products.
The Company also plans to conduct a follow-on public offering of its
Common Stock to provide the additional funds for clinical trials for its
oxidative stress assays, complete preclinical studies on synthetic
antioxidants, and initiate early clinical trials. There can be no
assurances that the Company will successfully complete such a follow-on
offering, that the terms of any such offering will be favorable to the
Company, or that if such offering occurs that funds generated thereby
will be sufficient to complete the Company's contemplated development
programs.
RESEARCH AND DEVELOPMENT STAGE PRODUCTS.
Much of the Company's success depends on potential products which
are in research and development and no material revenues have been
generated to date from sales of these products. Although the Company
currently markets and sells research and diagnostic assays,
8
the Company must successfully partner, develop, obtain regulatory
approval for and market or sell its potential therapeutic products to
achieve profitable operations. The preclinical and clinical development
work for potential new therapeutic products is presently in early
research and development stages. No assurance can be given that the
Company's product development efforts will be successfully completed,
that required regulatory approvals will be obtained, or that any such
products, if developed and introduced, will be successfully marketed. If
the Company does not successfully introduce new products, its revenues
and results of operations will be materially adversely affected.
FUTURE PROFITABILITY UNCERTAIN; CUSTOMER DEPENDENCY.
The Company expects to incur operating losses through 1996 and these
losses may increase and fluctuate from quarter to quarter as the Company
expands its development activities. There can be no assurance that the
Company will ever achieve profitable operations. The report of the
Company's independent auditors on the Company's financial statements for
the period ended December 31, 1994 included an explanatory paragraph
referring to the Company's ability to continue as a going concern. The
Company anticipates that it will expend significant capital resources in
product research and development. Capital resources may also be used for
the acquisition of complementary businesses, products or technologies.
OXIS' future capital requirements will depend on many factors, including:
continued scientific progress in its research and development programs;
the magnitude of these programs; success of preclinical and clinical
trials; scale-up costs of manufacturing; the time and costs required for
regulatory approvals; the time and costs involved in filing, prosecuting,
enforcing and defending patent claims; technological competition and
market developments; the establishment of and changes in collaborative
relationships; and the cost of commercialization activities and
arrangements.
While the Company believes that its new products and technologies
show considerable promise, its ability to realize significant revenues
therefrom is dependent upon the Company's success in developing business
alliances with biotechnology and/or pharmaceutical companies to develop
and market these products. There is no assurance that the Company's
effort to develop such business alliances will be successful. The
Company is pursuing one such potential alliance with Sanofi Winthrop with
respect to a therapeutic drug ("Sanofi Therapeutic") that Sanofi Winthrop
is endeavoring to develop. In May 1995, Sanofi Winthrop loaned the
Company $600,000 ("Sanofi Loan") which is due and payable in May 1996 and
pursuant to the terms of such loan the parties have agreed to use good
faith efforts to negotiate a license and supply agreement concerning the
Company's bovine SOD ("bSOD") technology and a license with respect to
the Company's recombinant human SOD technology. If Sanofi proceeds with
the development of the Sanofi Therapeutic, such an agreement would
provide that Sanofi would purchase bulk bSOD from the Company, or
purchase or license from the Company technology rights pertaining to the
manufacture of bSOD. It is important to note that the Company's long-
term ability to earn revenues associated with the sale of bSOD to Sanofi
Winthrop is based upon (i) the Sanofi Therapeutic being successfully
developed and receiving the requisite regulatory approvals, (ii) Sanofi
Winthrop successfully commercializing the Sanofi Therapeutic, and (iii)
the Company entering into a mutually satisfactory agreement with Sanofi
Winthrop for the supply of the Company's bSOD to Sanofi Winthrop or the
purchase or license from the Company of technology rights pertaining to
the manufacture of bSOD. Over the last several years the Company has sold
a substantial amount of bSOD to Sanofi Winthrop (35% of 1994 revenues).
There can be no assurances that such substantial sales will continue.
Although Sanofi Winthrop is currently conducting a second Phase III trial
on its drug, DISMUTEC(TM) (a coupled form of OXIS' bovine
9
superoxide dismutase) to treat closed head injury, the Company cannot
predict whether this trial will conclude successfully. If such trial is
not concluded successfully, the Company expects that future sales of bSOD
to Sanofi Winthrop would decrease substantially or cease altogether.
There are two sources of bovine superoxide dismutase (bSOD) that
have been sold in Europe, the product that is produced from bovine liver
using OXIS's manufacturing process, called Oxinorm(R) in Italy, and a
second product, Peroxinorm, that was manufactured by one of the Company's
licensees from blood. Peroxinorm was withdrawn from the market in
Germany and Austria, and all orgotein containing products, including
Oxinorm, were subsequently withdrawn from the market in Italy. (See
"Product Withdrawals in Europe, Licensees" following.)
Dismutec is composed of OXIS's bovine superoxide dismutase
chemically coupled to polyethylene glycol (PEG). Although the bSOD used
to produce Dismutec is the same substance that was distributed and
subsequently withdrawn in Italy (product labeled Oxinorm), Sanofi
Winthrop's Dismutec is in fact a different chemical entity due to the
chemical modification with PEG. The Company cannot predict what effect
the European withdrawals of bSOD may have on the international sales of
Dismutec, if it is approved.
PRODUCT WITHDRAWALS IN EUROPE; LICENSEES.
The European market for OXIS' bSOD (orgotein) for human use has been
adversely impacted by a series of recent regulatory developments. During
its twelve years of commercial availability in Europe, more than twelve
million injections (representing more than two million courses of
treatment) have been administered. Orgotein for injection as a human
pharmaceutical has been produced by two different manufacturing methods.
The first method involves production in accordance with OXIS' proprietary
manufacturing process by Diosynth B.V. ("Diosynth"), using USDA inspected
bovine livers. This preparation of orgotein for injection has been sold
under the trade names Oxinorm(R) in Italy and Ontosein(R) in Spain. The
second method involves manufacturing orgotein from bovine blood, rather
than bovine livers. The resultant product was manufactured and marketed
under the trade name Peroxinorm(R) by Grunenthal GmbH ("Grunenthal").
The Company's three European licensees have been responsible for a
substantial, though decreasing, portion of the Company's revenues in
recent years. Sales to, and royalties from, Grunenthal (German
licensee), Tedec-Meiji Farma, S.A. ("Tedec-Meiji") (Spanish licensee) and
SmithKline Beecham Farmaceutici S.p.a. ("SmithKline Beecham") (Italian
licensee) as a percentage of the Company's total revenues for the past
three years have been as follows:
10
1994 1993 1992
----- ----- ----
Grunenthal 9% 23% 66%
Tedec-Meiji 18% 8% 15%
SmithKline Beecham 2% 7% 10%
The Company expects that its revenues from sales to, and royalties from,
its European licensees in the foreseeable future will be substantially
less than historical levels. The Company does not anticipate any bSOD
sales to European licensees in 1995 other than to its Spanish licensee,
and the amount of sales to the Spanish licensee during, and beyond, 1995
cannot be predicted.
In January, 1994, the Italian government rendered a decision to
exclude all orgotein-containing products from the list of drugs eligible
for patient reimbursement. An appeal filed by OXIS' distributor of
Oxinorm, SmithKline Beecham, was denied. Subsequently, OXIS was informed
that the Italian Health Ministry has withdrawn the Marketing
Authorization of all pharmaceutical products composed of orgotein,
including Oxinorm. SmithKline Beecham informed the Company that it
believed it was entitled to recover from the Company the purchase price
of all of its Oxinorm inventory. SmithKline Beecham's Oxinorm inventory
previously was purchased from the Company's German licensee (Grunenthal).
The Company has agreed to purchase SmithKline Beecham's Oxinorm
inventory. Payment for the inventory is due within the next two years.
The Company believes that upon payment for the inventory it will have no
further liability to Grunenthal or SmithKline Beecham.
In addition, OXIS was notified in January, 1994 that the government
of Austria had asked Grunenthal to withdraw Peroxinorm from the Austrian
market. On March 25, 1994, as a result of two fatalities (December, 1993
and February, 1994) of patients treated with Peroxinorm, the German
Federal Health Administration asked Grunenthal to remove Peroxinorm from
the German market. No claim has been made against the Company in
connection with these two fatalities, and the Company does not believe
there is a substantial likelihood of any liability to it as a result of
these two fatalities.
In addition, the Company's licensee for Spain has had informal
discussions with the Spanish regulatory authorities regarding the
Company's bSOD product. Although no action has been taken by those
authorities with regard to the Company's product, future sales in Spain
may be adversely affected by either regulatory action in Spain, or safety
concerns stemming from actions in other countries. In addition,
Grunenthal, the Company's German licensee has advised the Company that
its Spanish subsidiary voluntarily withdrew its bSOD product from the
Spanish market.
The product withdrawals in various European countries have resulted
in a reduction of sales under the Company's license agreement with
Grunenthal, which has caused a reduction in royalties being paid the
Company under that agreement. Sales of the Company's bSOD produced by
Diosynth have also been reduced as a result of the product withdrawal in
Italy.
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FAILURE TO PROTECT TECHNOLOGY COULD ADVERSELY AFFECT RESULTS.
The Company's success will depend in part on its proprietary
products and information. While OXIS has attempted to protect its
proprietary products and information through patents and trade secrets,
there can be no assurance that competitors will not be able to develop
similar products and information independently. No assurance can be
given that patents will be issued on certain of the Company's pending
applications or that the claims allowed on any patents held by the
Company will be sufficiently broad to protect its products and
information. In addition, no assurance can be given that any patents
issued to the Company will not be challenged, invalidated or circumvented
or that the rights granted thereunder will provide competitive advantages
to it.
In addition, the Company's products and its customers may be alleged
to have infringed third parties' patent rights. While such allegations
are commonplace in the industry and to date the Company has been able to
license necessary patents or technology on commercially reasonable terms,
there can be no assurance that the Company will be able to license
necessary patents or technology on commercially reasonable terms in the
future. No assurances can be given that the Company will prevail in any
infringement litigation or that the costs or damages from any such
litigation would not materially and adversely affect the Company.
Substantially all of the Company's assets (including OXIS'
technology) serve as security with respect to the repayment of various
loans, including the Sanofi Loan. A default under these loans could
result in the loss by the Company of certain of these assets serving as
collateral.
GOVERNMENT REGULATION; PRODUCT CLEARANCE AND APPROVAL UNCERTAIN.
As with other companies in its industry, OXIS' preclinical
development, clinical trials, product manufacturing and marketing are
subject to state and federal regulation by the United States and other
countries. Clinical trials and product marketing and manufacturing are
subject to the rigorous review and approval processes of the United
States Food and Drug Administration ("FDA") and foreign regulatory
authorities. The process of obtaining FDA and other required regulatory
approvals is lengthy and expensive. Typically, this requires the
expenditure of substantial resources and takes several years or more with
respect to therapeutic products (diagnostic products typically take a
significantly shorter period of time), depending upon the type,
complexity and novelty of the product and the nature of the disease or
other indication to be treated. Preclinical studies must be conducted in
conformance with the FDA's Good Laboratory Practice regulations.
Clinical testing must meet requirements for Institutional Review Board
("IRB") oversight and informed consent by clinical trial subjects, as
well as FDA prior review, oversight and the FDA's Good Clinical Practice
requirements. Clinical trials may require large numbers of test
subjects. OXIS has limited experience in conducting clinical testing and
in pursuing applications necessary to gain regulatory approvals.
Furthermore, the Company or the FDA may suspend clinical trials at any
time if either believes that the subjects participating in such trials
are being exposed to unacceptable health risks, including undesirable or
unintended side effects.
Before receiving FDA approval to market a product, OXIS may have to
demonstrate that the product represents an improved form of treatment
compared to existing therapies. Data obtained from preclinical and
clinical activities are susceptible to varying interpretations, which
could delay, limit or prevent regulatory approvals. In addition, delays
or rejections may be
12
encountered based upon additional government regulation from future
legislation or administrative action or changes in FDA policy during the
period of product development, clinical trials and FDA regulatory review.
Delays in obtaining such approvals could adversely affect marketing of
OXIS' products. Delays in regulatory approvals that may be encountered by
OXIS' joint development partners and licensees could adversely affect
OXIS' ability to receive royalties or other revenues. There can be no
assurance that, after such time and expenditures, regulatory approval
will be obtained for any products developed by the Company. Even after
initial FDA approval has been obtained, further studies may be required
to provide additional data on safety or to gain approval for the use of a
product as a treatment for clinical indications other than those
initially targeted. Moreover, the FDA may reconsider its approval of any
product at any time and may withdraw such approval. In addition, before
the Company's products can be marketed in foreign countries, they are
subject to regulatory approval in such countries similar to that required
in the United States. Furthermore, approval may entail ongoing
requirements for post-marketing studies.
The FDA's regulations require that any drug or formulation to be
tested in humans must be manufactured according to current Good
Manufacturing Practices regulations ("cGMPs"). This has been extended to
include any drugs which will be tested for safety in animals, in support
of human testing. The cGMPs set certain minimum requirements for
procedures, record-keeping and the physical characteristics of the
laboratories used in the production of these drugs. In addition, various
federal and state laws, regulations and recommendations relating to safe
working conditions, laboratory practices, the experimental use of animals
and the purchase, storage, movement, import and export, use, and disposal
of hazardous or potentially hazardous substances, including radioactive
compounds and infectious disease agents, used in connection with the
Company's research work are or may be applicable to their activities.
They include, among others, the United States Atomic Energy Act, the
Clean Air Act, the Clean Water Act, the Occupational Safety and Health
Act, the National Environmental Policy Act, the Toxic Substances Control
Act, and the Resources Conservation and Recovery Act, national
restrictions on technology transfer, import, export and customs
regulations, and other present and possible future local, state or
federal regulation. OXIS is unable to estimate the extent and impact of
regulation resulting from such future federal, state or local legislation
or administrative action.
Outside the United States, the Company's ability to market a product
is contingent upon receiving marketing authorization from the appropriate
foreign regulatory authorities. The requirements governing the conduct
of clinical trials, marketing authorization, pricing and reimbursement
vary widely from country to country. This foreign regulatory approval
process may include all of the risks associated with FDA approval set
forth above.
RISK OF PRODUCT LIABILITY; USE OF HAZARDOUS MATERIALS; LIMITED INSURANCE
COVERAGE.
The testing, marketing and sale of human therapeutic products
entails significant risks. If the Company succeeds in developing
products in these areas, use of such products in trials and the sale of
such products following regulatory approval may expose the Company to
liability claims allegedly resulting from use of such products. These
claims might be made directly by consumers or others. OXIS currently has
only limited insurance for its clinical trials. However, there can be no
assurance that OXIS will be able to obtain and maintain such insurance
for all of its clinical trials or that coverage will be in sufficient
amounts to protect against damages for liability that could have a
material adverse effect on OXIS. There can also be no assurance that
OXIS will be able to obtain or maintain product liability insurance in
the future on acceptable terms or in
13
sufficient amounts to protect the Company against damages for liability
that could have a material adverse effect on the Company.
In addition, the Company's research and development involves the
controlled use of hazardous materials, radioactive compounds and other
chemicals. Although the Company believes that its safety procedures for
handling and disposing of such materials comply with the standards
prescribed by state and federal regulations, the risk of accidental
contamination or injury from these materials cannot be completely
eliminated. In the event of such an accident, the Company could be held
liable for any damages that result and any such liability could exceed
the resources of the Company. The Company may incur substantial costs to
comply with environmental regulations if the Company develops additional
manufacturing capacity.
COMPANY IS IN HIGHLY COMPETITIVE BUSINESS.
The pharmaceutical industry is highly competitive. Competition in
most of the Company's primary current and potential product areas from
large pharmaceutical companies, and other companies, universities and
research institutions is intense and expected to increase. Relative to
the Company, many of these entities have substantially greater capital
resources, research and development staffs, facilities and experience in
conducting clinical trials and obtaining regulatory approvals, as well as
in manufacturing and marketing diagnostic and pharmaceutical products.
In addition, these and other entities may have or may develop new
technologies or use existing technologies that are, or may in the future
be, the basis for competitive products.
Any potential products that the Company succeeds in developing and
for which it gains regulatory approval will have to compete for market
acceptance and market share. For certain of the Company's potential
products, an important factor in such competition may be the timing of
market introduction of competitive products. Accordingly, the relative
speed with which the Company can develop products, complete the clinical
testing and regulatory approval processes and supply commercial
quantities of the product to the market are expected to be important
competitive factors. The Company expects that a competitive edge will be
based, among other things, on product efficacy, safety, reliability,
availability, timing and scope of regulatory approval and product price.
There can be no assurance that the Company's competitors will not develop
technologies and products that are more effective than those being
developed by the Company. In addition, certain of the Company's
competitors may achieve product commercialization or patent protection
prior to OXIS.
The Company's therapeutic drug monitoring products compete directly
with similar products from major diagnostic companies such as Abbott,
Roche Laboratories ("Roche"), E.I. DuPont de Nemours ("DuPont") and
others. Since one of the Company's business strategies is to provide
alternative reagents to customers who own or rent the Abbott
TDx(R)/TDxFLx(R) analyzers, Abbott is the Company's major competitor in
this area. The Company competes based on high product quality, an
aggressive pricing strategy and technical services. Alternatively, when
the Company develops custom assays for pharmaceutical companies,
exclusive manufacturing and marketing rights are generally granted that
may provide protection from competition. Market position for these
unique assays can be enhanced through patents and trade secrets, but in
the absence of such protection other companies could develop comparable
assays; and even if patent protection is obtained, competing companies
could still develop competitive assays.
14
The Company believes it is a leader in the development of assays for
markers of oxidative stress. Although there are currently a limited
number of competitors for the Company's assays to measure markers of
oxidative stress, no assurances can be given that significant competition
will not arise in the future.
Other pharmaceutical companies are competing with the Company to
develop therapeutic products to treat diseases of oxidative stress. The
Company estimates that over 20 companies have investigated the
therapeutic potential of SOD and the Company is not aware of any other
company currently pursuing development of bSOD for OXIS' target
indication, familial amyotrophic lateral sclerosis ("FALS"). Insofar as
the Company is aware, the only major company currently developing a bSOD
based therapeutic is Sanofi Winthrop. The Company provides bSOD to
Sanofi Winthrop for use in the Sanofi Therapeutic.
Some pharmaceutical companies are pursuing the development of
synthetic molecules to treat diseases of oxidative stress. The Company's
major competitors in the area of synthetic antioxidants include the
Upjohn Company ("Upjohn") and Free Radical Sciences, Inc. ("Free Radical
Sciences"). Upjohn has a number of ongoing trials to test the
therapeutic potential of a group of synthetic compounds called Lazaroids
in several disease indications, and Free Radical Sciences is testing a
drug called procysteine for use in Adult Respiratory Distress Syndrome
and other diseases. Natterman/Rhone Poulenc Rorer and Daiichi are also
developing glutathione peroxidase mimics.
MANUFACTURING/DEPENDENCE ON OTHERS.
Certain of the Company's products, and raw materials used in its
products, are produced by independent third parties. Accordingly, the
Company is and will continue to be dependent upon these third parties to
produce products and supply materials with acceptable quality and to
deliver them to the Company in a timely manner. The Company depends on
these manufacturers to achieve acceptable manufacturing yields and to
allocate to the Company a sufficient portion of their capacity to meet
the Company's needs. Although the Company has not experienced material
quality or allocation problems to date, there can be no assurance that
such problems will not have a material adverse effect on the Company's
business, financial condition and results of operations in the future.
Furthermore, constraints or delays in the supply of the Company's
products and materials used therein could result in the loss of
customers, the delay of development projects and other adverse effects on
the Company's business, financial condition and results of operations.
The Company's reliance on third party manufacturers and suppliers
involves several other risks, including reduced control over delivery
schedules, quality assurance and costs. Foreign manufacturers and
suppliers are subject to additional risks such as changes in governmental
policies, imposition of tariffs and import restrictions and other factors
beyond the Company's control.
From time to time the Company has experienced substantial
fluctuations in orders for the purchase of bulk bSOD. Such fluctuations
can complicate and create difficulties with respect to the manufacturing
process. There can be no assurance that such fluctuations will not occur
in the future.
15
POSSIBLE HEALTH CARE REFORM LEGISLATION AND HEALTH CARE COSTS.
OXIS' ability to successfully commercialize human therapeutic
products may depend in part on the extent to which reimbursement for the
cost of such products and related treatment will be available from
government health administration authorities, private health coverage
insurers and other organizations. Significant uncertainty exists as to
the reimbursement status of newly approved healthcare products, and there
can be no assurance that adequate third party coverage will be available
for OXIS to maintain price levels sufficient for realization of an
appropriate return on its investment in product development. Government
and other third-party payers are increasingly attempting to contain
healthcare costs by limiting both coverage and the level of reimbursement
for new therapeutic products approved for marketing by the FDA and by
refusing, in some cases, to provide any coverage for uses of approved
products for disease indications for which the FDA has not granted
marketing approval. If adequate coverage and reimbursement levels are
not provided by government and third-party payers for uses of OXIS'
healthcare products, the market acceptance of these products would be
adversely affected.
In addition, as with other companies which supply products and
services to the health care industry, the Company faces an uncertain
legislative environment. Over the last few years, the United States
Congress, the President and various state governments have advanced
various health care bills that could significantly alter the structure of
the health care industry. Regardless of whether or not a health care
bill is adopted, private businesses are placing pressures on health care
providers to reduce costs. The Company may be subjected to pressures or
a legislative mandate to reduce the prices of its pharmaceutical
products. This uncertain legislative environment may also adversely
affect the Company's ability to raise capital.
ACQUISITIONS; DIFFICULTIES AND COSTS OF INTEGRATION.
The transition to a unified company following the acquisition of IBC
and Bioxytech ("Combination") has required substantial attention from
management, which has limited experience in integrating companies
internationally. The diversion of management attention and any
difficulties encountered in the restructuring of the Company as a result
of the Combination and also as a result of the July 19, 1995 acquisition
of Therox, and in the subsequent transition process could have an adverse
impact on the business, revenues and operating results of the Company.
The Company's future success will also depend in large part upon its
ability to continue to integrate its U.S. and French operations.
Significant management attention will be required to integrate the
operations of its French subsidiary with those of its domestic
operations, and there can be no assurance that such integration will be
successful. As a result of the acquisition of Therox, the Company has
incurred additional expenses and charges and is required to devote
additional managerial attention with respect to the integration of all
the businesses.
FOREIGN CURRENCY AND TAX EXPOSURE.
The Company's French subsidiary conducts virtually all of its non-
U.S. business in currencies other than the U.S. dollar and the Company
buys and sells the majority of its SOD in a foreign currency.
Accordingly, foreign currency fluctuations may affect the Company's
earnings and asset valuations. The Company may be affected by laws
affecting its ability to repatriate foreign profits, if any, and by
foreign tax laws, as well as by fluctuating tax rates and changes in
16
international tax treaties. There can be no assurance that laws and
changes such as these will not have a material adverse impact on the
Company's operations.
LABOR LAWS IN FRANCE.
Certain of the Company's personnel are located in France. French
labor laws offer employees certain rights in the event of termination
which do not exist under U.S. laws. French labor laws may inhibit
management's ability to take future personnel actions or implement
certain operating plans (such as reducing the size of the French
subsidiary's operations).
INTERNATIONAL SALES.
The Company expects that international sales may account for a
substantial portion of the Company's future revenues. The Company's
business in foreign markets is and will be subject to the risks
customarily associated with such activities, including fluctuations in
foreign currency exchange rates and controls, expropriation,
nationalization and other economic, tax and regulatory policies of
foreign governments as well as the laws and policies of the United States
affecting foreign trade and investment.
FAILURE TO ATTRACT OR RETAIN KEY PERSONNEL COULD ADVERSELY AFFECT
RESULTS.
The Company is dependent upon the efforts and abilities of a number
of its key personnel. The success of the Company depends to a large
extent upon its ability to retain and attract key employees. The loss of
certain of these people or the Company's inability to attract and retain
other key employees could materially adversely affect results of
operations. This effect could be particularly significant if the Company
needs to hire, train and assimilate large numbers of new employees.
During the first half of 1995, Dr. Mark Saifer and Dr. Jean Chaudiere
resigned their positions as corporate vice presidents of the Company, but
they continue to be employed by the Company or by one of its
subsidiaries.
VOLATILITY OF STOCK PRICE; SHARES AVAILABLE FOR FUTURE SALE; ABSENCE OF
DIVIDENDS.
The market prices for securities of biotechnology and pharmaceutical
companies, including the securities of OXIS, have been volatile.
Announcements of technological innovations or new commercial products by
OXIS or its competitors, a change in status of a corporate partner,
developments concerning proprietary rights, including patents and
litigation matters, publicity regarding actual or potential medical
results with products under development by OXIS, regulatory developments
in both the United States and foreign countries and public concern as to
the safety of biotechnology or of pharmaceutical products, as well as
period-to-period fluctuations in revenues and financial results, may have
a significant impact on the market price of the Company's Common Stock.
OXIS has not paid any cash dividends since its inception, and it does not
anticipate paying cash dividends in the foreseeable future.
As of July 10, 1995, the Company had approximately 10,683,687 shares
of Common Stock outstanding. Of these, the Company issued approximately
4,380,092 shares of its Common Stock in connection with the acquisition
of Bioxytech S.A. and merger with International BioClinical, Inc. in
September 1994 (the "Combination"), certain of which are subject to
escrow and other restrictions (excluded are 107,670 shares of Common
Stock which have not yet been issued but may be issued to former
stockholders of Bioxytech if they are able to invest $1 million
17
in the proposed private placement referred to above). The Company also
has options or warrants outstanding to purchase approximately 1,710,763
shares of Common Stock. Pursuant to this Registration Statement, the
Company is registering for resale all of the shares of Common Stock
issued in the Combination (4,380,092) in addition to 95,418 shares
subject to options granted to former Bioxytech stockholders in the
Combination and 33,500 shares subject to options granted to former
International BioClinical, Inc. stockholders in the Combination. The
Company is also registering for resale an aggregate of 472,763 shares of
Common Stock issuable upon exercise of the Company's warrants, including
350,000 shares subject to warrants issued to employees and officers of
the Company from 1987 through 1989. 122,763 shares subject to a warrant
issued to the private placement agent of the Company in connection with
the Company's offshore placement of securities in May 1995, and is
registering 93,300 shares of Common Stock issued to certain shareholders
in connection with loans advanced to the Company in February 1995.
Subject to certain agreements limiting the number of shares certain of
the Selling Stockholders may sell (see "Plan of Distribution"), these
shares may be sold into the public securities markets after this
Registration Statement becomes effective. The registration of Common
Stock pursuant to this Registration Statement will result in an increase
of more than 100% in the number of shares of the Company's Common Stock
available for trading in the public securities market. Future sales of
Common Stock in the public securities markets may cause substantial
fluctuations (including substantial price reductions) in the price of the
Company's Common Stock over short time periods. Additionally, the price
of the Company's Common Stock will be sensitive to the performance and
prospects of the Company and other factors.
SHARE OWNERSHIP BY CERTAIN INDIVIDUALS AND CONCENTRATION OF OWNERSHIP.
Ray R. Rogers, the Chairman of OXIS, owns 672,368 shares of Common
Stock and options to purchase shares of Common Stock received in the
Combination ("Options") (excluding 240,771 shares owned by an irrevocable
trust for the benefit of Mr. Rogers' children as to which shares Mr.
Rogers has no control), and including shares received in the Combination
which are subject to escrow restrictions. Dr. Anna D. Barker, the
President and Chief Executive Officer of OXIS, owns 913,139 shares of
Common Stock and Options including shares received in the Combination
which are subject to escrow restrictions). Ownership of such Common
Stock and Options represents control by Mr. Rogers and Dr. Barker of
approximately 6.3% and 8.6% of the voting securities of OXIS,
respectively. Alta-Berkeley L.P. II is the owner of 550,774 shares of
Common Stock and Options, representing approximately 5.2% of the voting
securities of the Company. David Needham, a director of OXIS and a
consultant to the investment advisory firm which advises Alta Berkeley
L.P. II, has a stock option entitling him to purchase 15,000 shares of
Common Stock. Mr. Needham disclaims beneficial ownership of shares of
Common Stock owned by Alta Berkeley L.P.II. As the largest stockholders
of OXIS, Mr. Rogers, Dr. Barker and Alta Berkeley L.P. II are in a
position to significantly influence the outcome of matters (including the
election of directors, and any merger, consolidation or sale of all or
substantially all of the Company's assets) submitted to the Company's
stockholders for approval. As a result, certain transactions may not be
possible without the approval of Mr. Rogers, Dr. Barker and Alta-Berkeley
L.P. II. In addition, the Company's directors, executive officers and
principal stockholders and certain of their affiliates, as a group, have
the ability to influence the election of the Company's directors and most
other stockholder actions.
18
QUARTERLY OPERATING RESULTS AFFECTED BY MANY BUSINESS FACTORS.
The Company has experienced fluctuations in quarterly results and is
likely to continue to experience such fluctuations. Expense levels are
based, in part, on expectations of future revenues. If revenue levels in
a particular quarter are less than expected, operating results will be
affected adversely, which may have an adverse impact on the market price
of the Company's Common Stock. A variety of factors have an influence on
the level of revenues and expenses in a particular quarter. These
factors include specific economic conditions in the pharmaceutical
industry, the withdrawal or failure to grant requisite government
approvals, the timing of the receipt of orders from its major customer,
Sanofi Winthrop, customer cancellations or delay of shipments, production
delays, exchange rate fluctuations, management decisions to commence or
discontinue product lines, the introduction of new products by the
Company or its competitors, the timing of research and development
expenditures, and expenses attendant to acquisitions, strategic alliances
and the further development of marketing and service capabilities.
19
USE OF PROCEEDS
The Company will not receive any proceeds from the sale of Common
Stock by the Selling Stockholders in the offering. The Company will
receive a maximum aggregate amount of $1,818,693.97 assuming the exercise
of all options and warrants for which the resale of Common Stock is
registered hereby. No assurances can be given by the Company as to the
exercise of any of such options or warrants. Proceeds from the exercise
of such options and warrants, if any, are anticipated to be used for
working capital purposes.
20
SELLING STOCKHOLDERS
The following table sets forth the names of the Selling
Stockholders, the number of shares of Common Stock owned beneficially by
each of the Selling Stockholders as of August 29, 1995, and the number of
shares which may be offered for resale pursuant to this Prospectus.
This information is based upon information provided by the Selling
Stockholders. Because the Selling Stockholders may offer all, some or
none of their Common Stock, no definitive estimate as to the number of
shares thereof that will be held by the Selling Stockholders after such
offering can be provided and the following table has been prepared on the
assumption that all shares of Common Stock under this Prospectus will be
sold.
Shares Beneficially
Owned Prior to Shares Beneficially
Offering/(1)(2)/ Shares Being Owned After Offering/(3)/
Name Number Offered Number Percentage/(4)/
---- ------------------- ------------ -------------------------
Russell E. Teasdale /(5)(6)/ 220,000 220,000 0 0
Mark G.P. Saifer /(5)(7)/ 197,500 5,000 192,500 1.77%
L. David Williams/(5)/ 55,000 15,000 40,000 *
Marc A. Fisher/(5)/ 35,000 35,000 0 0
Carol C. Golsch/(5)/ 20,000 20,000 0 0
Carl Claassen/(5)/ 5,000 5,000 0 0
Rima Agamian/(5)/ 2,500 2,500 0 0
Ralph Somack/(5)/ 47,500 47,500 0 0
Anna D. Barker/(8)/ 913,139 876,139 37,000 *
H. Gerald Bidwell 33,440 33,440 0 0
Cascadia Pacific Management, 13,543 13,543 0 0
Inc.
Daniel Cawley 8,660 8,025 635 *
Terryl Dank 12,797 11,369 1,428 *
Kari Henderson 3,627 2,675 952 *
Debbie Heuvelhorst 3,768 2,340 1,428 *
Charles Martin 19,009 18,057 952 *
21
Shares Beneficially
Owned Prior to Shares Beneficially
Offering/(1)(2)/ Shares Being Owned After Offering/(3)/
Name Number Offered Number Percentage/(4)/
---- ------------------- ------------ -------------------------
Stephen H. Mastin 51,660 50,160 1,500 *
Paul Mueggler 36,278 34,778 1,500 *
Dennis Murray 7,213 6,420 793 *
Jon S. Pitcher/(9)/ 29,418 28,625 793 *
Harry Roberts/(10)/ 9,344 9,344 0 0
Ray R. Rogers/(11)/ 672,368 635,368 37,000 *
George Spencer as Trustee 240,771 240,771 0 0
for Rogers' Trusts dated
March 7, 1994/(12)/
Ken Stenglein 5,474 4,681 793 *
Anthony Miadich/(13)/ 7,500 7,500 0 0
Oregon Resource and 20,000 20,000 0 0
Technology Development
Fund/(14)/
Lynda Taylor 29,393 28,758 635 *
Innolion/(15)/ 540,670 540,670 0 0
Alta-Berkeley L.P. II/(16)/ 550,774 550,774 0 0
Sofinnova S.A./ (17)/ 161,288 161,288 0 0
Sofinnova Capital FCPR/(18)/ 242,021 242,021 0 0
Finovelec/(19)/ 429,762 429,762 0 0
Hemera II & Cie 132,630 132,630 0 0
Euroventures Germany C.V. 53,622 53,622 0 0
22
Shares Beneficially
Owned Prior to Shares Beneficially
Offering/(1)(2)/ Shares Being Owned After Offering/(3)/
Name Number Offered Number Percentage/(4)/
---- ------------------- ------------ -------------------------
Chimtex S.A. 27,117 27,117 0 0
Finbiotec SPA 31,785 31,785 0 0
Sumaru S.r.1 21,895 21,895 0 0
Sea Farming S.r.1 21,895 21,895 0 0
Jean Chaudiere/(20)/ 119,499 119,499 0 0
Christian Manuel 76,864 76,864 0 0
Estate of A Crastes 13,362 13,362 0 0
de Paulet/(21)/
Andre Capron 762 762 0 0
Michel Rigaud/(22)/ 13,366 13,366 0 0
Catherine Rice Evans 754 754 0 0
Bernard Jacotot 754 754 0 0
Yves Grosgogeat 754 754 0 0
Jean-Claude Yadan 64,549 49,638 14,911 *
Henry-Michel Bouillet 670 670 0 0
Andre Galli 503 503 0 0
Jacques Emerit 503 503 0 0
Marc Lange 503 503 0 0
John B. Hawken/(23)/ 24,231 24,231 0 0
Marc Moutet 38,732 29,784 8,948 *
Irene Erdelmeier 24,911 24,911 0 0
Bailey & Co./(24)/ 122,763 122,763 0 0
--------- --------- ------- ----
Total: 5,416,841 5,075,073 341,768 3.11%
========= ========= ======= ====
23
* less than 1% of the issued and outstanding Common Stock of the
Company.
(1) Unless otherwise indicated in the footnotes to this table, the
persons and entities named in the table have sole voting and sole
investment power with respect to all shares beneficially owned,
subject to community property laws where applicable.
(2) As required by regulations of the Securities and Exchange
Commission, the number of shares in the table includes shares which
can be purchased within 60 days.
(3) Assumes the sale of all shares offered hereby. As required by
regulations of the Securities and Exchange Commission, each
percentage reported in the table for these individuals is calculated
as though shares which can be purchased within 60 days have been
purchased by the respective person or group and are outstanding.
(4) Applicable percentage of ownership is based on 10,683,687 shares of
Common Stock outstanding on July 10, 1995.
(5) Includes with respect to the following persons, the following
number of shares which may be acquired through the exercise of stock
warrants: Russell E. Teasdale (220,000); Mark G.P. Saifer (195,000);
L. David Williams (55,000); Marc Fisher (35,000); Carol Golsch
(20,000); Carl Claassen (5,000); Rima Agamian (2,500); Ralph Somack
(47,500). Mssrs. Claassen and Fisher are former directors of the
Company.
(6) Russell Teasdale has been employed by the Company as a consultant
and is a former executive officer of the Company.
(7) Mark Saifer resigned as an executive officer of the Company during
1995, but continues to be an employee of the Company.
(8) Anna Barker is a director of the Company and its President and Chief
Executive Officer. Figure in first column includes 35,000 shares
which may be acquired by exercise of options.
(9) Jon Pitcher is the Company's Chief Financial Officer.
(10) Includes 6,000 shares which may be acquired on exercise of options.
(11) Ray R. Rogers is a director and the Chairman of the Board of
Directors of the Company. Figure in first column includes 20,000
owned by his individual retirement account, as to which Rogers
exercises voting and investment power, and excludes 240,771 shares
owned by an irrevocable trust for the benefit of his children.
George C. Spencer is the trustee under such irrevocable trust.
George C. Spencer is a partner of Tonkon, Torp, Galen, Marmaduke &
Booth, a law firm which represents the Company. Figure in first
column also includes 20,000 shares which may be acquired by exercise
of options.
(12) See Note (11) above.
(13) Includes 7,500 shares which may be acquired on exercise of options.
(14) Includes 20,000 shares which may be acquired on exercise of options.
(15) Includes 18,424 shares which may be acquired on exercise of options.
(16) Includes 16,452 shares which may be acquired on exercise of options.
(17) Includes 4,792 shares which may be acquired on exercise of options.
(18) Includes 7,184 shares which may be acquired on exercise of options.
(19) Includes 2,786 shares which may be acquired on exercise of options.
(20) Jean Chaudiere resigned as an executive officer of the Company
during 1995, but continues as the President of Bioxytech, the
Company's French subsidiary.
(21) Includes 5,963 shares which may be acquired upon exercise of
options.
(22) Includes 5,963 shares which may be acquired upon exercise of
options.
(23) Includes 23,854 shares which may be acquired on exercise of options.
(24) Includes 122,763 shares which may be acquired on exercise of
warrants.
24
PLAN OF DISTRIBUTION
The Company is registering the shares of Common Stock offered by the
Selling Stockholders hereunder in certain instances on a voluntary basis
and otherwise pursuant to contractual registration rights contained in
two Registration Rights Agreements entered into on September 7, 1994 (the
"Registration Rights Agreements"), the terms of certain warrants dated
March 13, 1987 through August 21, 1988 and an engagement letter providing
for a warrant dated May 23, 1995.
Pursuant to the terms of the Registration Rights Agreements, no
Selling Stockholders party to the Registration Rights Agreement may sell
during (i) any three month period while this Registration Statement is in
effect, a number of shares of Common Stock which are Registrable
Securities (as defined in the Registration Rights Agreements) that is
greater than one percent (1%) of the number of issued and outstanding
Common Stock at such time and (ii) any single month while this
Registration Statement is in effect, a number of shares of Registrable
Securities that is more than one-third (1/3) of one percent (1%) of the
number of issued and outstanding Common Stock at such time. Within ten
(10) days following the last day of any month in which a Selling
Stockholder party to the Registration Rights Agreement sells Registrable
Securities, any such Selling Stockholder must notify the Company of the
number of shares of Registrable Securities sold by such Selling
Stockholder.
The Registration Rights Agreements also provide that if the Company
proposes to register any of its stock or other securities under the
Securities Act in connection with an underwritten public offering of such
securities solely for cash, the Company shall, at such time, promptly
give each Selling Stockholder party to the Registration Rights Agreement
written notice of such registration, and in connection with such public
offering, the Selling Stockholders party to the Registration Rights
Agreement have agreed not to sell any of the Registrable Securities
during such customary lock-up period requested by the Company's
underwriters who are underwriting such public offering. The Selling
Stockholders party to the Registration Rights Agreement shall have no
right to participate in any such public offering.
Subject to the foregoing restrictions with respect to those Selling
Stockholders which are parties to either of the Registration Rights
Agreements, the shares of Common Stock offered hereunder may be sold from
time to time by the Selling Stockholders, or by pledgees, donees,
transferees or other successors in interest. Such sales may be made on
the Nasdaq National Market or in the over-the-counter market or otherwise
at prices and on terms then prevailing or related to the then current
market price, or in negotiated transactions. The shares of Common Stock
may be sold to or through one or more broker-dealers, acting as agent or
principal in underwriting offerings, block trades, agency placements,
exchange distributions, brokerage transactions or otherwise, or in any
combination of transactions.
In connection with any transaction involving the Common Stock,
broker-dealers or others may receive from the Selling Stockholders, and
may in turn pay to other broker-dealers or others, compensation in the
form of commissions, discounts or concessions in amounts to be negotiated
at the time. Broker-dealers and any other persons participating in a
distribution of the Common Stock may be deemed to be "underwriters'
within the meaning of the Act in connection with such
25
distribution, and any such commissions, discounts or concessions may be
deemed to be underwriting discounts or commissions under the Act.
Any or all of the sales or other transactions involving the Common
Stock described above, whether effected by the Selling Stockholders, any
broker dealer or others, may be made pursuant to this prospectus. In
addition, any shares of Common Stock that qualify for sale pursuant to
Rule 144 under the Act may be sold under Rule 144 rather than pursuant to
this prospectus.
In order to comply with the securities laws of certain states, if
applicable, the Common Stock may be sold in such jurisdictions only
through registered or licensed brokers or dealers. In addition, shares
of Common Stock may not be sold unless they have been registered or
qualified for sale or an exemption from registration or qualification
requirements is available and is complied with under applicable state
securities laws.
The Company and the Selling Stockholders have agreed, and hereafter
may further agree, to indemnify certain persons, including broker-dealers
or others, against certain liabilities in connection with any offering of
the Common Stock, including liabilities arising under the Act.
LEGAL MATTERS
The validity of the Common Stock offered hereby will be passed upon
for the Company by Jackson, Tufts, Cole & Black, San Jose, California.
EXPERTS
The financial statements and schedules incorporated by reference in
this Prospectus from the Company's Annual Report on Form 10-K for the
fiscal year ended December 31, 1994, as amended, have been audited by
Deloitte & Touche LLP, independent auditors, as stated in their report
which is incorporated herein by reference (which report expresses an
unqualified opinion and includes an explanatory paragraph referring to
the Company's ability to continue as a going concern), and have been so
incorporated in reliance upon the report of such firm given upon their
authority as experts in accounting and auditing.
26
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth all expenses, other than the
underwriting discounts and commissions, payable by the Registrant in
connection with the sale of the Common Stock being registered. All the
amounts shown are estimates except for the registration fee.
Registration fee $ 5,250
Blue sky qualification fees and expenses 5,000
Printing and engraving expenses 10,000
Legal fees and expenses 25,000
Accounting fees and expenses 5,000
Miscellaneous 2,000
-------
Total $52,250
=======
ITEM 15. INDEMNIFICATION OF OFFICERS AND DIRECTORS.
The Company has the power, pursuant to Section 102(7) of the
Delaware General Corporation Law, to limit the liability of directors of
the Company for certain breaches of fiduciary duty and, pursuant to
Section 145 of the Delaware General Corporation Law, to indemnify its
officers and directors and other persons for certain acts.
The Company's Restated Certificate of Incorporation includes the
following provisions:
"A director of the Company shall not be personally liable to the
company 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 Company or its
stockholders, (ii) for acts or omissions not in good faith or which
involve intentional misconduct or a knowing violation of law, (iii)
under Section 174 of the Delaware General Corporation Law or (iv)
for any transaction from which the director derived an improper
personal benefit. If the Delaware General Corporation Law is
amended to authorize corporate action further eliminating or
limiting the personal liability of directors, then the liability of
a director of the Company shall be eliminated or limited to the
fullest extent permitted by the Delaware General Corporation Law, as
so amended. Any repeal or modification of this Article by the
stockholders of the Company shall not adversely affect any right or
protection of a director of the Company existing at the time of such
repeal or modification."
"The Company shall indemnify any and all persons whom it has the
power to indemnify pursuant to the General Corporation Law of
Delaware against any and all expenses, judgments, fines, amounts
paid in settlement, and any other liabilities to the fullest extent
permitted by such law and may at the discretion of the Board of
Directors, purchase and maintain insurance, at its expense, to
protect itself and such persons against any expense, judgment, fine,
amount paid in settlement or
27
other liability, whether or not the Company would have the power to
so indemnify such person under the General Corporation Law of
Delaware."
Pursuant to Section 145 of the Delaware Law, a corporation generally
has the power to indemnify its present and former directors, officers,
employees and agents against expenses incurred by them in connection with
any suit to which they are, or are threatened to be made, a party by
reason of their serving in such positions so long as they acted in good
faith and in a manner they reasonably believed to be in, or not opposed
to, the best interests of a corporation, and with respect to any criminal
action, they had no reasonable cause to believe their conduct was
unlawful. The Company believes that these provisions are necessary to
attract and retain qualified persons as directors and officers. These
provisions do not eliminate liability for breach of the director's duty
of loyalty to the Company or its stockholders, for acts or omissions not
in good faith or involving intentional misconduct or knowing violations
of law, for any transaction from which the director derived an improper
personal benefit or for any willful or negligent payment of any unlawful
dividend or any unlawful stock purchase agreement or redemption.
Section 145 of the Delaware General Corporation Law authorizes a
court to award, or a corporation's board of directors to grant
indemnification to directors and officers in terms sufficiently broad to
permit such indemnification under certain circumstances for liabilities
(including reimbursement for expenses incurred) arising under the
Securities Act.
Article III of the Company's Bylaws provides that the Company, by
action of the Board of Directors, may, to the fullest extent permitted by
the General Corporation Law of Delaware, indemnify any and all persons
who it shall have power to indemnify against any and all of the expenses,
liabilities or other matters.
The Company has purchased and maintains an insurance policy covering
the officers and directors of the Company with respect to certain
liabilities arising under the Securities Act or otherwise.
ITEM 16. EXHIBITS
(a) Exhibits.
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
- ------- -------------------------------------------------
5.1 Opinion of Jackson, Tufts, Cole & Black.*
10.1 Term Loan Agreement dated as of May 2, 1995
between OXIS International, Inc., Bioxytech,
S.A. and Sanofi S.A. and related Promissory Note
in the principal amount of $600,000.*
23.1 Consent of Deloitte & Touche LLP.
23.2 Consent of Jackson, Tufts, Cole & Black.
Reference is made to Exhibit 5.1.*
* Previously filed.
28
ITEM 17. UNDERTAKINGS
Insofar as indemnification for liabilities arising under the Act may
be permitted to directors, officers and controlling persons of the
Company pursuant to provisions described in Item 15, or otherwise, the
Company has been advised that in the opinion of the Commission such
indemnification is against public policy as expressed in the Act and is,
therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the Company of
expenses incurred or paid by a director, officer or controlling person of
the Company 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 Company 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
whether such indemnification by it is against public policy as expressed
in the Act and will be governed by the final adjudication of such issue.
The undersigned Company hereby undertakes:
(1) To file, during any period in which offers or sales are being
made, a post-effective amendment to this registration statement to
include any material information with respect to the plan of distribution
not previously disclosed in the registration statement or any material
change to such information in the registration statement.
(2) That, for the purpose of determining any liability under the
Act, 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.
(3) To remove from registration by means of a post-effective
amendment any of the securities being registered which remain unsold at
the termination of the offering.
(4) That, for purposes of determining any liability under the Act,
each filing of the Company's annual report pursuant to Section 13(a) or
15(d) of the Exchange Act (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to Section 15(d) of the
Exchange Act) that is incorporated by reference in the 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.
(5) That, for purposes of determining any liability under the Act,
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 Company pursuant to Rule 424(b)(1) or (4) or
497(h) under the Act shall be deemed to be part of this Registration
Statement as of the time it was declared effective.
(6) To deliver or cause to be delivered with the Prospectus, to each
person to whom the Prospectus is sent or given, the latest annual report
to security holders that is incorporated by reference in the Prospectus
and furnished pursuant to and meeting the requirements of Rule 14a-3 or
Rule 14c-3 under the Exchange Act; and, where interim financial
information required to be presented by Article 3 of Regulation S-X are
not set forth in the Prospectus, to deliver, or cause to be delivered to
each person to whom the Prospectus is sent or given, the latest quarterly
report that is specifically incorporated by reference in the Prospectus
to provide such interim financial information.
29
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
Company has duly caused this Registration Statement to be signed on its
behalf by the undersigned, thereunto duly authorized, in the city of
Portland, State of Oregon, on the 30th day of August, 1995.
OXIS INTERNATIONAL, INC.
By: s/Anna D. Barker
-------------------------------------
Anna D. Barker, Ph.D.
President and Chief Executive Officer
(Principal Executive Officer)
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed below by the following persons in
the capacities and on the dates indicated.
SIGNATURE TITLE DATE
- ----------------------------- ------------------------------- ---------------
s/Anna D. Barker Director; President and Chief August 30, 1995
- ----------------------------- Executive Officer
Anna D. Barker (Principal Executive Officer)
s/Jon S. Pitcher* Chief Financial Officer August 30, 1995
- ----------------------------- (Principal Financial and
Jon S. Pitcher Accounting Officer)
s/Ray R. Rogers* Director; Chairman of the Board August 30, 1995
- -----------------------------
Ray R. Rogers
s/Gerald D. Mayer* Director August 30, 1995
- -----------------------------
Gerald D. Mayer
30
s/Peter E. Taussig* Director August 30, 1995
- -----------------------------
Peter E. Taussig
s/Lawrance A. Brown, Jr.* Director August 30, 1995
- -----------------------------
Lawrance A. Brown, Jr.
s/David Needham* Director August 30, 1995
- -----------------------------
David Needham
s/A.R. Sitaraman* Director August 30, 1995
- -----------------------------
A.R. Sitaraman
Director August 30, 1995
- ----------------------------- -------------------------------
Timothy G. Biro
*Anna D. Barker, by signing her name hereto, does sign this
Amendment No. 1 to Registration Statement on behalf of each of the
persons indicated above pursuant to the powers of attorney duly executed
by such persons and filed with the Securities and Exchange Commission.
s/Anna D. Barker
----------------
Anna D. Barker
Attorney-in-Fact
31
INDEX TO EXHIBITS
EXHIBIT SEQUENTIAL
NUMBER DESCRIPTION PAGE NO.
- ---------------------------------------------------------------------------------
5.1 Opinion of Jackson, Tufts, Cole & *
Black
- ---------------------------------------------------------------------------------
10.1 Term Loan Agreement dated as of May *
2, 1995 between OXIS International,
Inc., Bioxytech, S.A. and Sanofi
S.A. and related Promissory Note in
the principal amount of $600,000
- ---------------------------------------------------------------------------------
23.1 Consent of Deloitte & Touche LLP 33
- ---------------------------------------------------------------------------------
23.2 Consent of Jackson, Tufts, Cole & *
Black. Reference is made to
Exhibit 5.1
- --------------------------------------------------------------------------------
* Previously filed
32