<PAGE> 1
PROSPECTUS
Filed pursuant to Rule 424(b)(3)
Registration No. 333-60297
264,000 Shares
ORAVAX, INC.
Common Stock
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This Prospectus covers the resale of up to 264,000 shares of Common Stock,
$0.001 par value per share (the "Common Stock") of OraVax, Inc. ("OraVax" or the
"Company") by certain stockholders of the Company (the "Selling Stockholders").
See "Selling Stockholders." 240,000 of the shares of Common Stock covered by
this Prospectus were issued to the Selling Stockholders pursuant to the several
Stock Purchase Agreements between the Company and the Selling Stockholders, each
dated as of December 23, 1997 (collectively, the "Purchase Agreements"). The
remaining 24,000 shares of Common Stock may be issuable to Selling Stockholders
who received certain warrants to acquire Common Stock in connection with the
services of Cappello Capital Corp. as placement agent. All of the shares offered
hereunder are to be sold by the Selling Stockholders. The Company will not
receive any of the proceeds from the sale of the shares by the Selling
Stockholders.
The shares covered by this Prospectus represent the number of shares that
may be offered as of the date of this Prospectus based upon the present number
of shares held by the Selling Stockholders. The actual number of shares of
Common Stock offered hereby is subject to adjustment and could be materially
more than the amount indicated depending upon the application of the
anti-dilution provisions of the Purchase Agreements to sales of additional
shares of Common Stock by the Company.
The Selling Stockholders may from time to time sell the shares covered by
this Prospectus on the Nasdaq National Market in ordinary brokerage
transactions, in negotiated transactions, or otherwise, at market prices
prevailing at the time of sale or at negotiated prices. See "Plan of
Distribution." The Common Stock is traded on the Nasdaq National Market under
the symbol "ORVX".
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THE SHARES OFFERED HEREBY INVOLVE A HIGH DEGREE
OF RISK. SEE "RISK FACTORS" BEGINNING ON PAGE 5.
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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.
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The date of this Prospectus is August 10, 1998.
<PAGE> 2
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and in accordance
therewith files reports, proxy statements and other information with the
Securities and Exchange Commission (the "Commission"). Such reports, proxy
statements and other information filed by the Company with the Commission
pursuant to the informational requirements of the Exchange Act may be inspected
and copied at the public reference facilities maintained by the Commission at
450 Fifth Street, N.W., Room 1024, Washington, D.C. 20549 and at the
Commission's regional offices located at Seven World Trade Center, Suite 1300,
New York, New York 10048, and at Citicorp Center, 500 West Madison Street, Suite
1400, Chicago, Illinois 60661. Copies of such materials also may be obtained
from the Public Reference Section of the Commission at 450 Fifth Street, N.W.,
Washington, D.C. 20549 at prescribed rates. In addition, the Company is required
to file electronic versions of these documents through the Commission's
Electronic Data Gathering, Analysis and Retrieval system (EDGAR). The Commission
maintains a World Wide Web site at http://www.sec.gov that contains reports,
proxy and information statements and other information regarding registrants
that file electronically with the Commission. The Common Stock of the Company is
traded on the Nasdaq National Market. Reports and other information concerning
the Company may be inspected at the National Association of Securities Dealers,
Inc., 1735 K Street, N.W., Washington, D.C. 20006.
The Company has filed with the Commission a Registration Statement on Form
S-3 (together with all amendments, supplements, exhibits and schedules thereto,
the "Registration Statement") under the Securities Act of 1933, as amended (the
"Securities Act"), with respect to the shares of Common Stock offered hereby.
This Prospectus does not contain all of the information set forth in the
Registration Statement, as certain items are omitted in accordance with the
rules and regulations of the Commission. For further information pertaining to
the Company and the shares of Common Stock offered hereby, reference is made to
the Registration Statement. Statements contained in this Prospectus regarding
the contents of any agreement or other document are not necessarily complete,
and in each instance reference is made to the copy of such agreement or document
filed as an exhibit to the Registration Statement, each such statement being
qualified in all respects by such reference. The Registration Statement,
including all exhibits and schedules thereto, may be inspected without charge at
the office of the Commission at 450 Fifth Street, N.W., Washington, D.C. 20549,
and copies of all or any part thereof may be obtained from the Commission at
prescribed rates.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents filed by the Company with the Commission are
incorporated herein by reference:
(i) The Company's Annual Report on Form 10-K for the year ended
December 31, 1997, as filed with the Commission on March 31,
1998;
(ii) The Company's Quarterly Report on Form 10-Q for the quarterly
period ended March 31, 1998, as filed with the Commission on
May 14, 1998; and
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(iii) The Company's Registration Statement on Form 8-A registering the
Common Stock under Section 12(g) of the Exchange Act, as filed
with the Commission on May 8, 1995.
All documents filed by the Company with the Commission pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Exchange Act subsequent to the date hereof and
prior to the termination of the offering of the Common Stock registered hereby
shall be deemed to be incorporated by reference into this Prospectus and to be a
part hereof from the date of filing such documents. Any statement contained 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 other subsequently filed
document which also is or is deemed to be incorporated by reference herein
modifies or supersedes such statement. Any 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 to whom this
Prospectus is delivered, upon written or oral request of such person, a copy of
any or all of the foregoing documents incorporated by reference into this
Prospectus (without exhibits to such documents other than exhibits specifically
incorporated by reference into such documents). All such requests shall be
directed to: OraVax, Inc., 38 Sidney Street, Cambridge, Massachusetts 02139,
Attention: Vice President, Finance, Telephone: (617) 494-1339.
NO PERSON HAS BEEN AUTHORIZED TO GIVE ANY INFORMATION OR TO MAKE ANY
REPRESENTATIONS IN CONNECTION WITH THIS OFFERING OTHER THAN THOSE CONTAINED IN
THIS PROSPECTUS AND, IF GIVEN OR MADE, SUCH OTHER INFORMATION AND
REPRESENTATIONS MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE
COMPANY. NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE HEREUNDER
SHALL, UNDER ANY CIRCUMSTANCES, CREATE ANY IMPLICATION THAT THERE HAS BEEN NO
CHANGE IN THE AFFAIRS OF THE COMPANY SINCE THE DATE HEREOF OR THAT THE
INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY TIME SUBSEQUENT TO ITS DATE.
THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION OF AN
OFFER TO BUY ANY SECURITIES OTHER THAN THE REGISTERED SECURITIES TO WHICH IT
RELATES. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION
OF AN OFFER TO BUY SUCH SECURITIES IN ANY CIRCUMSTANCES IN WHICH SUCH OFFER OR
SOLICITATION IS UNLAWFUL.
SPECIAL NOTE REGARDING FORWARD-LOOKING INFORMATION
Certain statements in this Prospectus and in the documents incorporated
herein constitute "forward-looking statements" within the meaning of Section 27A
of the Securities Act and Section 2B of the Exchange Act. For this purpose, any
statements contained herein or incorporated herein that are not statements of
historical fact may be deemed to be forward-looking statements. Without limiting
the foregoing, the words "believes," "plans," "expects" and similar expressions
are intended to identify forward-looking statements. There are a number of
important factors that could cause the results of the Company to differ
materially from those indicated by such forward-looking statements. These
factors include those set forth in "Risk Factors" herein.
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THE COMPANY
The mission of OraVax, Inc. ("OraVax" or the "Company") is the discovery,
development and commercialization of biologic products for the prevention or
treatment of human infectious diseases. The Company's products are vaccines that
stimulate the body's own immunity to provide long term protection against
disease, as well as antibody products that provide immediate passive immunity to
treat existing infections or to protect against an acute disease risk. The
Company employs both classical biologic product methods and innovative
technologies to produce therapeutics and preventatives that meet the challenges
of each infection and disease process.
The Company was incorporated in Delaware in 1990 and has its principal
offices and laboratories at 38 Sidney Street, Cambridge, Massachusetts
(telephone: 617-494-1339).
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RISK FACTORS
The shares of Common Stock offered hereby include a high degree of risk.
The following risk factors should be considered carefully in addition to the
other information included or incorporated by reference in this Prospectus
before purchasing the Shares offered hereby.
Early Stage of Product Development. The products under development by the
Company will require significant additional research and development efforts,
including extensive clinical testing and regulatory approval, prior to
commercial use. The Company's potential products are subject to the risks of
failure inherent in the development of pharmaceutical products based on new
technologies. These risks include the possibilities that the Company's
therapeutic approach will not be successful, that any or all of the Company's
potential products will be found to be unsafe, ineffective, toxic or otherwise
fail to meet applicable regulatory standards or receive necessary regulatory
clearances, that the potential products, if safe and effective, will be
difficult to develop into commercially viable products, to manufacture on a
large scale or be uneconomical to market, that proprietary rights of competitors
or other parties will preclude the Company from marketing such products; or that
competitors or other parties will market superior or equivalent products.
Future Capital Needs. In addition, the Company will require substantial
additional funds in order to continue its research and development programs,
preclinical and clinical testing of its product candidates and to conduct full
scale manufacturing and marketing of any pharmaceutical products that may be
developed. The Company's capital requirements depend on numerous factors,
including but not limited to the progress of its research and development
programs, the progress of preclinical and clinical testing, the time and costs
involved in obtaining regulatory approvals, the cost of filing, prosecuting,
defending and enforcing any patent claims and other intellectual property
rights, competing technological and market developments, changes in the
Company's existing research relationships, the ability of the Company to
establish collaborative arrangements, the development of commercialization
activities and arrangements, and the purchase of additional facilities and
capital equipment. The Company believes, based upon its current operating plan,
that, in addition to its available cash balances and known revenues, it will
need additional financing, in the second half of 1998, in order to fund the
Company's planned operations. Possible sources of capital include strategic
corporate partnerships and private equity financing, both of which the Company
is actively pursuing. There can be no assurance, however, that changes in the
Company's research and development plans, acquisitions or other events affecting
the Company's operations will not result in accelerated or unexpected
expenditures. Thereafter, the Company will need to raise substantial additional
capital to fund its operations. There can be no assurance, however, that
additional financing will be available, or if available, will be available on
acceptable or affordable terms.
Manufacturing Limitations. At present, the Company's ability to manufacture
its products is limited to clinical trial quantities. The Company does not have
the capability to manufacture commercial quantities of products. The Company's
long-term strategy is to develop manufacturing facilities for producing both
pilot-scale and commercial quantities of its products. To ensure compliance with
current Good Manufacturing Practices ("cGMP") imposed by the FDA, OraVax will
need to establish sufficient technical staff to oversee all product operations,
including quality control, quality assurance, technical support and
manufacturing management. The Company may enter into arrangements with contract
manufacturing companies to expand its own production capacity in order to meet
requirements for its product candidates. If the Company chooses to contract for
manufacturing services and encounters delays or difficulties in establishing
relationships with manufacturers to produce, package and distribute its finished
pharmaceutical or other medical products (if any), clinical trials, market
introduction and subsequent sales of such products would be adversely affected.
Moreover, contract manufacturers must operate in compliance with cGMP. The
Company's potential dependence upon third parties for the manufacture of its
products may adversely
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<PAGE> 6
affect the Company's profit margins and its ability to develop and deliver such
products on a timely and competitive basis.
Risks Associated with Collaborative Arrangements. The Company's product
development strategy may require the Company to enter into various additional
arrangements with corporate, government and academic collaborators, licensors,
licensees and others. Therefore, the Company may be dependent upon the
subsequent success of these outside parties in performing their
responsibilities. There can be no assurance that the Company will be able to
establish additional collaborative arrangements or license agreements that the
Company deems necessary or acceptable to develop and commercialize its potential
pharmaceutical products or that such collaborative arrangements or license
agreements will be successful.
Patent and Proprietary Rights. The Company seeks to protect its trade
secrets and proprietary know-how, in part, through confidentiality agreements
with its employees, consultants, advisors and collaborators. There can be no
assurance that these agreements will not be violated by the other parties, that
OraVax will have adequate remedies for any breach, or that the Company's trade
secrets will not otherwise become known or be independently developed by
competitors. Certain of the technology that may be used in the products of
OraVax is not covered by any patent applications relating to the Company's
product candidates will result in patents being issued. Moreover, there can be
no assurance that any such patents will afford protection against competitors
with similar technology. There may be pending or issued third-party patents
relating to the product candidates of OraVax. OraVax may need to acquire
licenses to, or to contest validity of, any such third party patents. It is
likely that significant funds would be required to defend any claim that OraVax
infringes a third-party patent, and any such claim could adversely affect sales
of the challenged product of OraVax until the claim is resolved. There can be no
assurance that any license required under any such patent would be made
available.
Government Regulation. The rigorous preclinical and clinical testing
requirements and regulatory approval process of the FDA and of foreign
regulatory authorities can take a number of years and require the expenditure of
substantial resources. The Company has limited experience in conducting and
managing preclinical and clinical testing necessary to obtain government
approvals. There can be no assurance that the Company will be able to obtain the
necessary approvals for clinical testing or for the manufacturing and marketing
of any products that it develops. Additional government regulation may be
established that could prevent or delay regulatory approval of the Company's
product candidates. Delays in obtaining regulatory approvals would adversely
affect the marketing of any products developed by the Company and the Company's
ability to receive product revenues or royalties. If regulatory approval of a
potential product is granted, such approval may include significant limitations
on the indications for which such product may be marketed. Even if initial
regulatory approvals for the Company's product candidates are obtained, the
Company, its products and its manufacturing facilities are subject to continual
review and periodic inspection. The regulatory standards for manufacturing are
applied stringently by the FDA. Discovery of previously unknown problems with a
product, manufacturer or facility may result in restrictions on such product or
manufacturer or facility, including warning letters, fines, suspensions of
regulatory approvals, product recalls, operating restrictions, delays in
obtaining new product approvals, product recalls, operating restrictions, delays
in obtaining new product approvals, withdrawal of the product from the market,
and criminal prosecution. Other violations of FDA requirements can result in
similar penalties.
Uncertainty of Third-Party Reimbursement. Government and other third-party
payers are increasingly attempting to contain healthcare costs by limiting both
coverage and the level of reimbursement for new 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
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<PAGE> 7
not granted marketing approval. If adequate coverage and reimbursement levels
are not provided by government and third party payers for uses of the Company's
products, the market acceptance of these products would be adversely affected.
Year 2000 Issues. The approaching millennium ("Year 2000") could result in
challenges related to the Company's computer software, accounting records and
relationships with suppliers, collaborative partners and licensees. Management
of the Company is studying Year 2000 issues and is seeking to avoid such
problems. Based on the Company's review of its business and operating systems,
the Company does not expect to incur material costs with respect to assessing
and remediating Year 2000 problems; however, there can be no assurance that such
problems will not be encountered or that the costs incurred to resolve such
problems will not be material.
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USE OF PROCEEDS
The Company will not receive any proceeds from the sale of Common Stock by
the Selling Stockholders.
THE PURCHASE AGREEMENTS
On December 23, 1997, the Company completed a private placement of 240,000
shares (the "Shares") of Common Stock pursuant to which it received gross
proceeds of $459,000. All of the Shares were sold in private placements solely
to accredited investors under the Securities Act. The Company is obligated to
register the Shares for resale under the Securities Act and is doing so herein.
The placement agent for the private placement described above was Cappello
Capital Corp. (the "Placement Agent"). In consideration for its services, the
Placement Agent received aggregate cash compensation of 8.5% of the gross
proceeds received by the Company, or $39,015, and certain designees of the
Placement Agent received warrants (the "Warrants") to acquire an aggregate of
24,000 shares of Common Stock for a purchase price of $1.9125 per share. The
Company is obligated to register the shares of Common Stock issuable upon
exercise of the Warrants for resale under the Securities Act and is doing so
herein.
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<PAGE> 9
THE SELLING STOCKHOLDERS
The following table sets forth the name and the number of shares of Common
Stock beneficially owned by each of the Selling Stockholders as of July 1, 1998,
the number of the shares to be offered by each of the Selling Stockholders and
the number and percentage of shares to be owned beneficially by each of the
Selling Stockholders if all of the shares offered hereby by the Selling
Stockholders are sold as described herein.
<TABLE>
<CAPTION>
Number of Shares of Number of Shares Percentage of
Common Stock Number of Shares of Common Stock Shares of Common
Name of Beneficially Owned of Common Stock Beneficially Owned Stock Owned After
Selling Stockholder Prior to Offering Offered Hereby(1) After Offering Offering(2)
------------------- ------------------- ----------------- ------------------ -----------------
<S> <C> <C> <C> <C>
DFA Group Trust - Small
Company Subtrust 126,000 126,000 -- --
U.S. 9-10 Small Company
Portfolio 59,400 59,400 -- --
DFA Group Trust - 6-10
Subtrust 49,100 49,100 -- --
Linda S. Cappello 427,394(3) 10,800 416,594(3) 3.7%
Gerard K. Cappello 321,549(4) 7,200 314,349(4) 2.8%
Lawrence K. Fleischman 177,859(5) 6,000 171,859(5) 1.6%
U.S. 6-10 Small Company
Series 5,500 5,500 -- --
</TABLE>
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(1) The actual number of shares of Common Stock offered hereby is subject to
adjustment and could be materially more than the amount indicated depending
upon application of the anti-dilution provisions of the Purchase Agreements
to sales of additional shares of Common Stock by the Company.
(2) Assumes no purchase of additional shares of Common Stock.
(3) Includes 416,594 shares of Common Stock issuable as of July 1, 1998 upon
conversion of shares of the Company's 6% Convertible Preferred Stock
beneficially held by Ms. Cappello.
(4) Includes 314,349 shares of Common Stock issuable as of July 1, 1998 upon
conversion of shares of the Company's 6% Convertible Preferred Stock
beneficially held by Mr. Cappello.
(5) Includes 171,859 shares of Common Stock issuable as of July 1, 1998 upon
conversion of shares of the Company's 6% Convertible Preferred Stock
beneficially held by Mr. Fleischman.
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PLAN OF DISTRIBUTION
Shares of Common Stock covered hereby may be offered and sold from time to
time by the Selling Stockholders. The Selling Stockholders will act
independently of the Company in making decisions with respect to the timing,
manner and size of each sale. Such sales may be made in the over-the-counter
market or otherwise, at prices related to the then current market price or in
negotiated transactions, including pursuant to an underwritten offering or one
or more of the following methods: (a) purchases by a broker-dealer as principal
and resale by such broker or dealer for its account pursuant to this Prospectus;
(b) ordinary brokerage transactions and transactions in which the broker
solicits purchasers; and (c) block trades in which the broker-dealer so engaged
will attempt to sell the shares as agent but may position and resell a portion
of the block as principal to facilitate the transaction. In effecting sales,
broker-dealers engaged by the Selling Stockholders may receive commissions or
discounts from the Selling Stockholders in amounts to be negotiated immediately
prior to the sale. The Purchase Agreements provides that the Company will
indemnify the Selling Stockholders against certain liabilities, including
liabilities under the Securities Act.
In offering the shares of Common Stock covered hereby, the Selling
Stockholders and any broker-dealers and any other participating broker-dealers
who execute sales for the Selling Stockholders may be deemed to be
"underwriters" within the meaning of the Securities Act in connection with such
sales, and any profits realized by the Selling Stockholders and the compensation
of such broker-dealer may be deemed to be underwriting discounts and
commissions.
The Company has advised the Selling Stockholders that during such time as
they may be engaged in a distribution of Common Stock included herein they are
required to comply with Rules 10b-6 and 10b-7 under the Exchange Act and, in
connection therewith, that they may not engage in any stabilization activity in
connection with the Company's securities, are required to furnish to each
broker-dealer through which Common Stock included herein may be offered copies
of this Prospectus, and may not bid for or purchase any securities of the
Company or attempt to induce any person to purchase any securities of the
Company except as permitted under the Exchange Act.
Rule 10b-6 under the Exchange Act prohibits, with certain exceptions,
participants in a distribution from bidding for or purchasing, for an account in
which the participant has a beneficial interest, any of the securities that are
the subject of the distribution. Rule 10b-7 governs bids and purchases made in
order to stabilize the price of a security in connection with a distribution of
the security.
This offering will terminate on the date on which all shares offered hereby
have been sold by the Selling Stockholders.
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LEGAL MATTERS
The validity of the shares offered hereby will be passed upon for the
Company by Hale and Dorr LLP, 60 State Street, Boston, Massachusetts 02109.
EXPERTS
The consolidated balance sheets of the Company as of December 31, 1996 and
1997 and the consolidated statements of operations, stockholders' equity
(deficit) and cash flows for each of the three years in the period ended
December 31, 1997, all appearing in the Company's Annual Report on Form 10-K
have been audited by PricewaterhouseCoopers LLP, independent accountants, 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 firm given upon their authority as experts in
accounting and auditing.
The combined financial statements of OraVax Merieux Co. and Merieux OraVax
Co. appearing in the Company's Annual Report on Form 10-K have been audited by
PricewaterhouseCoopers LLP, as set forth in their report thereon included
therein and incorporated herein by reference. Such combined financial
statements are incorporated herein by reference in reliance upon such firm
given upon their authority as experts in accounting and auditing.
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NO DEALER, SALESPERSON 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 INFORMATION OR REPRESENTATIONS MUST NOT
BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY OR THE SELLING
STOCKHOLDER. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL OR A
SOLICITATION OF ANY OFFER TO BUY TO ANY PERSON IN ANY JURISDICTION IN WHICH SUCH
OFFER OR SOLICITATION OF AN OFFER OR SOLICITATION WOULD BE UNLAWFUL. NEITHER THE
DELIVERY OF THIS PROSPECTUS NOR ANY OFFER OR SALE HEREUNDER SHALL, UNDER ANY
CIRCUMSTANCES, CREATE ANY IMPLICATION THAT THERE HAS BEEN NO CHANGE IN THE
AFFAIRS OF THE COMPANY OR THAT THE INFORMATION CONTAINED HEREIN IS CORRECT AS OF
ANY DATE HEREOF.
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<TABLE>
<CAPTION>
TABLE OF CONTENTS
Page
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<S> <C>
Available Information.................................................. 2
Incorporation of Certain Documents
By Reference....................................................... 2
Special Note Regarding Forward-Looking
Information.......................................................... 3
The Company............................................................ 4
Risk Factors........................................................... 5
Use of Proceeds........................................................ 8
The Purchase Agreements................................................ 8
The Selling Stockholders............................................... 9
Plan of Distribution................................................... 10
Legal Matters.......................................................... 11
Experts................................................................ 11
</TABLE>
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ORAVAX, INC.
264,000 SHARES
COMMON STOCK
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PROSPECTUS
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August 10, 1998
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