As filed with the Securities and Exchange Commission on September 30, 1998
Registration Statement No. 333-56755
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
--------------------
POST-EFFECTIVE AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
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AVANT IMMUNOTHERAPEUTICS, INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction
of incorporation or organization)
13-3191702
(I.R.S. Employer
Identification Number)
--------------------
119 Fourth Avenue
Needham, Massachusetts 02194
(781) 433-0771
(Address, including zip code and telephone
number, including area code, of Registrant's
principal executive offices)
--------------------
Una S. Ryan, Ph.D.
President and Chief Executive Officer
AVANT Immunotherapeutics, Inc.
119 Fourth Avenue
Needham, Massachusetts 02194
(781) 433-0771
(Name, address, including zip code, and telephone number,
including area code of agent for service)
--------------------
Copies of all communications should be sent
to:
Stuart M. Cable, Esq.
Goodwin, Procter & Hoar LLP
Exchange Place
Boston, Massachusetts 02109-2881
(617) 570-1000
--------------------
Approximate date of commencement of proposed sale to the public:
From time to time after the effective date of this Registration Statement.
If the only securities being registered on this form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. [ ]
If any of the securities being registered on this form are to be offered
on a delayed or continuous basis pursuant to Rule 415 under the Securities Act
of 1933, other than securities offered only in connection with dividend or
interest reinvestment plans, check the following box. |X|
If this form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [ ]
If this form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule
434, please check the following box. [ ]
-------------------------
The Registrant hereby amends this Registration Statement on such date or
dates as may be necessary to delay its effective date until the Registrant shall
file a further amendment which specifically states that this Registration
Statement shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to Section 8(a), may
determine.
PROSPECTUS
AVANT IMMUNOTHERAPEUTICS, INC.
(f/k/a T Cell Sciences, Inc.)
1,968,494 Shares of Common Stock
This Prospectus relates to 1,968,494 shares (the "Shares") of common
stock, par value $.001 per share (the "Common Stock"), of AVANT
Immunotherapeutics, Inc. (the "Company" or "AVANT," formerly "T Cell Sciences,
Inc.") to be sold by certain stockholders of the Company (the "Selling
Stockholders") from time to time. The Selling Stockholders may sell the Shares
from time to time in transactions on the Nasdaq National Market System, in
negotiated transactions or by a combination of these methods, at fixed prices
that may be changed, at market prices at the time of sale, at prices related to
market prices or at negotiated prices. The Selling Stockholders may effect these
transactions by selling the Shares to or through broker-dealers, who may receive
compensation in the form of discounts or commissions from the Selling
Stockholders or from the purchasers of the Shares for whom the broker-dealers
may act as an agent or to whom they may sell as a principal, or both. See
"Selling Stockholders" and "Plan of Distribution." The Common Stock of the
Company is traded under the symbol "AVAN" on the Nasdaq National Market. On
September 28, 1998, the reported closing price for the Common Stock on the
Nasdaq National Market was $1.1875.
The Company will not receive any of the proceeds from the sale of the
Shares. The Company has agreed to bear all of the expenses in connection with
the registration and sale of the Shares (other than underwriting discounts and
selling commissions).
See "Risk Factors" beginning on page 3 for a discussion of certain
special factors which should be considered by prospective investors in
purchasing the shares of Common Stock offered hereby.
--------------------------------------------
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE COMMISSION
NOR HAS THE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE
ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE
CONTRARY IS A CRIMINAL OFFENSE.
--------------------------------------------
The date of this Prospectus is September 30, 1998
AVAILABLE INFORMATION
The Company has filed with the Securities and Exchange Commission (the
"Commission"), Washington, D.C. 20549, a Registration Statement (which term
shall include all amendments, exhibits and schedules thereto) on Form S-3 under
the Securities Act of 1933 (the "Securities Act") with respect to the shares of
Common Stock offered hereby. This Prospectus, which constitutes a part of the
Registration Statement, does not contain all of the information set forth in the
Registration Statement, certain parts of which are omitted in accordance with
the rules and regulations of the Commission, to which Registration Statement
reference is hereby made. For further information with respect to the Company
and the securities covered hereby, reference is made to the Registration
Statement and to the exhibits thereto filed as a part thereof. The Registration
Statement and the exhibits thereto may be inspected and copied at prescribed
rates at the public reference facilities maintained by the Commission at Room
1024, Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C. 20549 and at the
regional offices of the Commission located at Seven World Trade Center, 13th
Floor, New York, New York 10048 and 500 West Madison Street, Suite 1400,
Chicago, Illinois 60661, and copies may be obtained at the prescribed rates from
the Public Reference section of the Commission at its principal office in
Washington, D.C. The Commission also maintains a Web site at http://www.sec.gov
containing reports, proxy and information statements and other information
regarding registrants, including the Company, that file electronically with the
Commission. Statements made in this Prospectus as to the contents of any
contract, agreement or other document referred to are not necessarily complete.
With respect to each such contract, agreement or other document filed as an
exhibit to the Registration Statement, reference is made to the exhibit for a
more complete description of the matter involved, and each such statement shall
be deemed qualified in its entirety by such reference.
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 proxy statements, reports and other information with
the Commission. Such proxy statements, reports and other information filed by
the Company may be inspected and copied at prescribed rates at the
aforementioned public reference facilities maintained by the Commission. The
Common Stock of the Company is traded on the Nasdaq National Market System.
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.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents filed by the Company with the Commission are
incorporated in, and made a part of, this Prospectus by reference as of their
respective dates: (1) the Company's Annual Report on Form 10-K and 10-K/A for
the fiscal year ended December 31, 1997; (2) the Company's Quarterly Report on
Form 10-Q and 10-Q/A for the quarter ended March 31, 1998; (3) the Company's
Quarterly Report on Form 10-Q for the quarter ended June 30, 1998; (4) the
Company's Current Report on Form 8-K, filed on August 21, 1998; (5) the
Company's Current Report on Form 8-K, filed on August 28, 1998; (6) the
Company's Current Report on Form 8-K/A, filed on September 29, 1998; and (7)
the description of the Common Stock of the Company contained in the Company's
Registration Statement on Form 8-A, filed on September 22, 1986, including all
amendments and reports updating such description.
Each document filed subsequent to the date of this Prospectus pursuant
to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the
termination of this offering shall be deemed to be incorporated by reference in
this Prospectus and shall be a part hereof from the date of filing of such
document. The Company will furnish without charge to each person, including any
beneficial owner, to whom this Prospectus is delivered, upon written or oral
request, a copy of any or all of the documents that have been incorporated by
reference to the Registration Statement of which this Prospectus is a part,
other than exhibits to such documents. Requests should be addressed to: AVANT
Immunotherapeutics, Inc., 119 Fourth Avenue, Needham, Massachusetts 02194,
Attention: Corporate Secretary (telephone number (781) 433-0771).
2
This Prospectus, including the information incorporated by reference
herein, contains forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended. The words "believe," "expect," "anticipate,"
"intend," "estimate," "assume" and other similar expressions which are
predictions of or indicate future events and trends and which do not relate
solely to historical matters identify forward-looking statements. Reliance
should not be placed on forward- looking statements because they involve known
and unknown risks, uncertainties and other factors, which are in some cases
beyond the control of the Company (as defined herein) and may cause the actual
results, performance or achievements of the Company to differ materially from
anticipated future results, performance or achievements expressed or implied by
such forward-looking statements.
RISK FACTORS
The purchase of the shares of Common Stock entails very significant
risks. In addition to the other information contained or incorporated by
reference in this Prospectus, the following factors should be considered
carefully in evaluating an investment in the shares of Common Stock offered by
this Prospectus.
Early Stage of Product Development; Uncertainties Relating to Clinical
Trials and Product Development. All of the Company's product candidates are in
various stages of research and development and no revenues have been generated
from the commercialization of these products. There can be no assurance that any
of the Company's product candidates which are under development will prove to be
safe or effective in clinical trials, will be approved by regulatory
authorities, can be manufactured at acceptable cost with appropriate quality, or
can be successfully marketed. The Company's product candidates will require
substantial additional development, including in the areas of preclinical and
clinical testing, regulatory approvals and manufacturing processes prior to
their commercialization. The Company has performed only limited preclinical and
clinical testing of certain of its product candidates and technologies under
development. Preclinical studies of product candidates may not predict and do
not ensure safety or efficacy in humans and are not necessarily indicative of
the results that may be achieved in clinical trials with humans. There can be no
assurance that unacceptable side effects will not be discovered during
preclinical and clinical testing of the Company's potential products. As results
of particular preclinical studies and clinical trials are received by the
Company, the Company may abandon projects which it might otherwise have believed
to be promising. Even after being cleared by the United States Food and Drug
Administration (the "FDA") or the regulatory authorities of other countries, a
product may later be shown to be unsafe or to not have its purported effect,
thereby preventing its widespread use or requiring its withdrawal from the
market.
The rate of completion of the Company's clinical trials depends, among
other factors, on the rate of patient enrollment. Patient enrollment is a
function of many factors, including the size of the patient population, the
nature of the clinical protocol, the proximity of patients to clinical sites and
the eligibility criteria for the trial. Delays in planned patient enrollment may
result in increased costs, delays or termination of clinical trials, which could
have a material adverse effect on the Company's business, financial condition
and results of operations. In addition, the Company may rely on third parties to
assist it in overseeing and monitoring clinical trials, which may result in
delays in completing, or failure to complete, clinical trials if such third
parties fail to perform under their agreements with the Company or fail to meet
regulatory standards in the performance of their obligations under such
agreements.
In addition, the product development programs conducted by the Company
and its collaborators are subject to the risks of failure inherent in the
development of product candidates based on new technologies. These risks include
the possibility that the technologies used by the Company will prove to be
ineffective; that any or all of the Company's products will prove to be unsafe
or toxic or otherwise fail to receive necessary regulatory approvals; that the
product
3
candidates, if safe and effective, will be difficult to manufacture on a large
scale or uneconomical to market; that the proprietary rights of third parties
will preclude the Company or its collaborators from marketing such products
utilizing the Company's technologies; or that third parties will market superior
or equivalent products.
History of Losses; Uncertainty of Future Profitability. The Company has
incurred substantial operating losses since its inception and currently has
substantial net losses. The continued development of the Company's products will
require the commitment of substantial resources to conduct research and
preclinical and clinical programs, to establish manufacturing capabilities and
sales and marketing capabilities, and to establish additional quality control,
regulatory and administrative capabilities. The Company may incur substantial
operating losses over the next several years as its product development programs
and clinical testing expand. The Company's operating losses could fluctuate from
quarter to quarter and such fluctuations could be substantial. The amount of net
losses and the time required by the Company to reach sustained profitability are
highly uncertain and to achieve profitability the Company must, among other
things, successfully complete development of its products, obtain regulatory
approvals and establish manufacturing and marketing capabilities, each of which
may not occur. There can be no assurance that the Company will be able to
achieve profitability at all or on a sustained basis.
Need for Additional Funds. The Company has funded its operations and
capital expenditures to date primarily through equity financing, strategic
alliances with commercial partners, and sales of reagent and diagnostic
products. The Company anticipates that it will need to raise substantial
additional funds, through additional equity or debt financings, research and
development financings, collaborative relationships or otherwise, prior to the
commercialization of its products. There can be no assurance that any such
additional funding will be available to the Company or, if available, that it
will be on reasonable terms. Any such additional funding may result in
significant dilution to existing stockholders. If adequate funds are not
available, the Company may be required to significantly curtail its research and
development programs, obtain funds through arrangements with collaborative
partners that may require the Company to relinquish certain material rights to
its technologies, product candidates or products or to license the rights to
such products on terms that are less favorable to the Company than might
otherwise be available.
Dependence on Third Parties for Clinical Supplies; Collaborative
Agreements. The Company is dependent on sourcing from a third-party manufacturer
for suitable quantities of certain items including soluble Complement Receptor 1
("sCR1") and other materials necessary for preclinical and clinical studies and
for clinical trials in addition to those currently being conducted by the
Company. The inability to have suitable quality and quantities of material
produced in a timely manner would result in significant delays in the clinical
development and sale of products, which could adversely affect the Company's
business, financial condition and results of operations. The Company plans to
rely on collaborators and contract manufacturers to manufacture certain proposed
products in both clinical and commercial quantities in the future. There can be
no assurances that the Company will be able to enter into any arrangements with
such third-party manufacturers on acceptable terms or at all.
The Company has entered into agreements with certain pharmaceutical and
biotechnology companies relating to the licensing, development and
commercialization of certain products utilizing the Company's technologies and
proprietary information. In some cases, the Company's collaborator has assumed
substantial responsibility to commercialize the Company's products which may
allow such collaborators substantial discretion in determining the amount and
timing of resources to be devoted to such efforts. The Company may enter into
similar agreements in the future. Should a collaborative partner fail to
successfully develop or commercialize, or elect not to develop or commercialize,
any product candidate to which it has exclusive rights, the Company's business
prospects may be materially and adversely affected. There can be no assurance
that the Company's collaborators will continue their development efforts using
the Company's technology or that such development efforts, if continued, will be
successful. There can also be no assurance that the Company would be able to
continue development of certain of its products if the Company's collaborators
failed to do so. Collaborative agreements may also require the Company to meet
certain milestones and expend funds, and there can be no assurance that the
Company will be successful in achieving these
4
milestones. Failure of the Company to meet such obligations could result in a
termination of those agreements and could have a material adverse effect on the
Company's results of operations and business prospects.
Certain of the Company's collaboration agreements will require further
research and development to determine the feasibility of developing certain
products utilizing the Company's vaccine delivery systems. In some cases, the
programs that are the subject of the Company's collaboration agreements are in
the early stages of research and development, and the collaboration agreements
may require the negotiation and execution of further licenses or other
agreements. There can be no assurance that any products will be developed from
such agreements or that any license agreements will be entered into relating to
products developed under such agreements. There also can be no assurance that
the Company's collaborators will not pursue alternative technologies or product
candidates, either on their own or in collaboration with others, that compete
with the technologies or product candidates being developed pursuant to such
collaborators' agreements with the Company.
All of the risks set forth in this section relating to the Company and
its business are generally applicable as well to the Company's collaborators to
the extent that the Company's products are to be developed or commercialized
through collaborative arrangements.
No Assurance of FDA Approval; Comprehensive Government Regulation. The
Company's research, development and clinical programs, and ultimately the
production and marketing of products are subject to extensive regulation,
including rigorous testing programs and approval processes, by numerous
governmental authorities in the United States, including the FDA, and
corresponding regulatory authorities in other countries where the Company
intends to test and market its products. Most of the Company's products will
require governmental approvals for commercialization which have not yet been
obtained and are not expected to be obtained for several years. There can be no
assurance that the Company will be able to obtain the necessary clearances for
clinical trials or approvals for manufacturing or marketing any of its product
candidates.
The regulatory process, which includes preclinical, clinical and
post-clinical testing of many of the Company's products to establish their
safety and efficacy, can take many years and requires the expenditure of
substantial resources. FDA approval of a new product must be obtained after
completion of clinical trials but before commencing the marketing and
manufacturing of the product. Furthermore, to commercialize any product and
prior to submitting the application for marketing approval in the United States,
the Company must sponsor and file an Investigational New Drug ("IND")
application for each proposed product and must be responsible for initiating and
overseeing the clinical studies to demonstrate the safety and efficacy that are
necessary to obtain FDA approval of such product. The Company expects that its
products will be regulated as biologics. Traditionally, both a Product License
Application and an Establishment License Application have been required prior to
commercial marketing. License applications submitted to the FDA have
historically taken several years to receive approval. The FDA will be proposing
regulations to implement the new Biologics License Application ("BLA") provision
in the Food and Drug Administration Modernization Act of 1997 (the "FDA
Modernization Act"), which allows for a single license application. The FDA
Modernization Act sets as a goal for the FDA the review and action on a complete
license application within 12 months. If the FDA determines that an application
is incomplete, or that important issues are unanswered by the data in the
application, approval times could be delayed significantly. In addition, delays
or rejection may be encountered based upon changes in, or additions to,
regulatory policies for drug approval during the period of product development
and regulatory review, which may result in limitations or restrictions on the
Company's ability to utilize its technology or develop its products. Delays in
obtaining such approvals could adversely affect the marketing of products
developed by the Company and the Company's ability to generate commercial
product revenues and could furnish a competitive advantage to competitors of the
Company. Notwithstanding the submission of relevant data, the FDA may ultimately
decide that the license application does not satisfy its criteria for approval
and there can be no assurances that this will not occur.
5
Even if regulatory approval of a product is granted, a marketed product
is subject to continual review. Later discovery of previously unknown problems
or failure to comply with the applicable regulatory requirements may result in
restrictions on the marketing of a product or withdrawal of the product from the
market as well as possible civil or criminal sanctions. In addition, the
manufacturing facility for the Company's products will be subject to FDA
inspection for adherence to current Good Manufacturing Practice ("cGMP")
regulations prior to marketing clearance and periodically following approval.
This will require the Company or its contractor/collaborator to observe rigorous
manufacturing specifications. There can be no assurance that requisite
regulatory approvals will be obtained within a reasonable period of time, if at
all, or that the Company will not encounter problems that will cause the Company
or governmental authorities to delay or suspend the manufacturing and marketing
of its products.
Moreover, if regulatory approval of a product is granted, such approval
may impose limitations on the indicated uses for which such product may be
marketed which may, among other things, restrict the patient population for
which any product may be prescribed.
Dependence on Manufacturing, Sales, Distribution and Marketing Partners.
To be successful, the Company's products must be manufactured in commercial
quantities, within regulatory requirements and at competitive costs. There can
be no assurance that the Company will be able to obtain access to suitable
product manufacturing facilities. Except for research reagents and certain
diagnostic products, the Company has limited experience in sales, marketing and
distribution of commercial products. To market any of its products directly, the
Company must develop a substantial marketing and sales force with technical
expertise and a supporting distribution capability. There can be no assurance
that the Company will be able to establish sales and distribution capabilities
without undue delays or expenditures or that it will be successful in gaining
market acceptance for its products. The Company may also enter into strategic
partnerships for the manufacturing, sales, distribution and marketing of its
products. There can be no assurance the Company will be able to enter into
successful strategic partnership agreements on terms acceptable to the Company,
if at all.
Competition and Risk of Technological Obsolescence. Biotechnology,
pharmaceuticals and therapeutics are rapidly evolving fields in which
developments are expected to continue at a rapid pace. Competitors of the
Company in the United States and abroad are numerous and include, among others,
pharmaceuticals, therapeutics and biotechnology companies as well as
universities and other research institutions some of which specialize in the
development and production of vaccines, adjuvants, vaccine and immunotherapeutic
delivery systems and other products and technology which compete with the
Company's business. The Company's success depends upon developing and
maintaining a competitive position in the development of products and
technologies in its area of focus. Competition from other biotechnology,
pharmaceuticals and therapeutics companies is intense and expected to increase
as new products enter the market and new technologies become available. The
Company's competitors may succeed in developing technologies and products on a
more rapid schedule or that are more effective than any which have been or are
being developed by the Company or that otherwise render the Company's
technologies or products obsolete or noncompetitive. The Company's competitors
may also succeed in obtaining patent protection or other intellectual property
rights that would block the Company's ability to develop its potential products,
or in obtaining regulatory approval for the commercialization of their products
more rapidly or effectively than the Company. Finally, many of these competitors
have substantially greater research and development capabilities, clinical,
manufacturing, regulatory and marketing experience and financial and managerial
resources than the Company. There can be no assurance that the products under
development by the Company will be able to compete successfully with existing
products or products under development by other companies, universities and
other institutions or that they will obtain regulatory approval in the United
States or elsewhere.
Dependence on Patents and Proprietary Technology. The Company's success
will depend in part on the ability of the Company and its licensors to obtain
and/or maintain patent protection for the Company's technology and products and
to preserve its trade secrets and operate without infringing on the proprietary
rights of others, both in
6
the United States and in other countries. The Company intends to file
applications as appropriate for patents covering both its products and its
processes. The failure of the Company or its licensors to obtain and maintain
patent protection for the Company's technology could have a material adverse
effect on the Company's business, financial condition and results of operations.
Patent positions in the biotechnology field are highly uncertain and involve
complex legal, scientific and factual questions. To date, there has emerged no
consistent policy regarding the breadth of claims allowed in biotechnology
patents, particularly in regard to human therapeutic uses. There can be no
assurance that patent applications relating to the technology used by the
Company will result in patents being issued or that, if issued, the patent will
not be subjected to further proceedings limiting the scope of the rights under
the patent or that such patent will provide a competitive advantage or will
afford protection against competitors with similar technology, or will not be
challenged successfully, invalidated or circumvented by competitors. Even if a
patent is issued to the Company, a successful challenge to the validity of that
patent could result in the ability of a third party to use the invention covered
by the patent, in some cases without payment to the Company. There can be no
assurance that the Company's patents will not be infringed or successfully
avoided.
Moreover, because patent applications in the United States are
maintained in secrecy until the patents are issued and patent applications in
certain other countries generally are not published until more than 18 months
after they are filed, and since publication of discoveries in scientific or
patent literature often lags behind actual discoveries, the Company cannot be
certain that it or any licensor was the first creator of inventions covered by
pending patent applications or that it or such licensor was the first to file
patent applications for such inventions. It is possible that third parties may
obtain patent or other proprietary rights that may be necessary or useful to the
Company. In cases where third parties are first to invent a particular product
or technology, it is possible that those parties will obtain patents that will
be sufficiently broad so as to prevent the Company from using certain technology
or from further developing or commercializing certain products. If licenses from
third parties are necessary but cannot be obtained, commercialization of the
related products would be delayed or prevented.
In addition, the Company could incur substantial costs in defending
itself in suits brought against it or in suits in which the Company may assert
its patents against others and there can be no assurance that the Company would
prevail in any such action. If the outcome of any such action is adverse to the
Company, the Company's business, financial condition and results of operations
could be materially adversely affected. In addition to any potential liability
for significant damages, the Company could be required to obtain licenses to
patents or other proprietary rights of third parties. Costs associated with any
licensing arrangement may be substantial and could include ongoing royalties. No
assurance can be given that any licenses required under any such patents or
proprietary rights would be made available on terms acceptable to the Company,
if at all. If the Company does not obtain such licenses, it could encounter
delays in product market introductions while it attempts to design around such
patents or other rights, or be prevented from manufacturing and marketing such
products. In either case, the failure to obtain such licenses on acceptable
terms, if at all, could have a material adverse effect on the Company's
business, financial condition and results of operations.
The Company also seeks to protect its proprietary technology, including
technology which may not be patented or patentable, in part by confidentiality
agreements and, if applicable, inventors' rights agreements with its
collaborators, advisors, employees and consultants. There can be no assurance
that these agreements will not be breached, that the Company will have adequate
remedies for any breach, or that the Company's trade secrets will not otherwise
be disclosed to, or discovered by, competitors. Moreover, the Company conducts a
significant amount of research through academic advisors and collaborators who
are prohibited from entering into confidentiality or inventors' rights
agreements by their academic institutions.
The Company has licensed certain intellectual property from third
parties. Under the terms of certain of its license agreements, the Company is
obligated to exercise diligence, achieve certain milestones and expend minimum
amounts of resources in bringing potential products to market and make certain
royalty and milestone payments, including a percentage of any sublicensing
income, as well as patent cost reimbursement payments. The licensors can
7
terminate these agreements or, in certain cases, make the licenses
non-exclusive, if the Company defaults in the performance of its obligations.
Should the Company default under any of these agreements, the Company may lose
its right to market and sell any products based on the licensed technology. In
such event, the Company's results of operations and business prospects could be
materially and adversely affected. There can be no assurance that the Company
will be able to meet its obligations under these agreements on a timely basis,
or at all. Further, the Company may be required to obtain licenses to additional
technologies to be utilized in some of the products under development by the
Company currently, or in the future. If any such licenses are not obtained by
the Company, the Company may not be able to market any such products.
Dependence on Reimbursement. In both the United States and elsewhere,
sales, if any, of most of the Company's products will be dependent in part on
the availability of reimbursement from third-party payors, such as government
health administration authorities, private health insurers and health
maintenance organizations ("HMOs"). Accordingly, the Company's success in
generating revenue from sales of products may depend, in part, on the extent to
which reimbursement for the costs of such products will be available from such
third-party payors. Third party- payors are increasingly challenging the prices
charged for medical products and services and limiting both coverage and the
level of reimbursement of new products approved for marketing by the FDA.
Moreover, the federal government of the United States has made the containment
of health care costs a top priority. The expansion of managed health care in the
United States and the concurrent growth of organizations such as HMOs, which
control or significantly influence the purchase of health care services and
products, as well as legislative proposals to reduce government insurance
programs, may all result in lower prices for pharmaceutical products and could
affect the market for such products. Accordingly, even if the Company succeeds
in bringing one or more products to market, there can be no assurance that these
products will be considered cost-effective, that reimbursement will be available
or, if available, that the level of reimbursement will be sufficient to allow
the Company to sell its products on a profitable basis. If adequate coverage and
reimbursement levels are not provided by government and third-party payors for
uses of the Company's products, the market acceptance of such products would be
adversely affected.
Health Care Reform. The health care industry in the United States and in
Europe is undergoing fundamental changes as the result of political, economic
and regulatory influences. Reforms proposed from time to time include (i)
mandated basic health care benefits, (ii) controls on health care spending
through limitations on the growth of private health insurance premiums and
Medicare and Medicaid spending, (iii) the creation of large insurance purchasing
groups and (iv) fundamental changes to the health care delivery system each of
which could limit or eliminate payments for certain medical procedures and
treatments or subject the pricing of pharmaceuticals to government control. The
Company anticipates that alternative health care delivery systems and methods of
payment will continue to be reviewed and assessed, and public debate of these
issues will likely continue. The Company cannot predict whether any reform
initiatives will result or, if adopted, what impact they might have on the
Company, and there can be no assurance that the adoption of reform proposals
will not have a material adverse effect on the Company's business, financial
condition and results of operations. Announcements of reform proposals and the
investment community's reaction to such proposals, announcements by competitors
and third-party payors of their strategy in responding to reform initiatives,
and general industry conditions could produce volatility in the trading and
market price of the Company's Common Stock.
Exposure to Product Liability Claims. The Company's business exposes it
to inherent risks of product liability claims, product recalls and associated
adverse publicity which are inherent in the testing, manufacturing, marketing
and sale of human vaccine and therapeutic products. The Company currently has
liability insurance of limited coverage. Certain circumstances, including the
Company's entering into collaborative agreements with other companies, could
require the Company to obtain additional levels of product liability insurance.
There can be no assurance that it will be able to maintain its current level of
insurance or obtain additional product liability insurance on acceptable terms
or at reasonable costs or that such insurance is or will be in sufficient
amounts to provide the Company with adequate coverage against potential
liabilities. A product liability claim or product recall could inhibit
8
or prevent commercialization of products being developed by the Company. Any
product liability claim or product recall could have a material adverse effect
on the Company's business, financial condition and results of operations.
Hazardous Materials; Environmental Matters. The Company's research and
development activities involve the controlled use of hazardous materials,
chemicals, biological materials and radioactive compounds. The Company is
subject to federal, state and local laws and regulations governing the use,
manufacture, storage, handling and disposal of such materials and certain waste
products. Although the Company believes that its safety procedures for handling
and disposing of such materials comply with the standards prescribed by such
laws and 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 resulting damages, and any such liability
could exceed the Company's resources. The Company may be required to incur
significant costs to comply with environmental laws and regulations in the
future. Current or future environmental laws or regulation may have a material
adverse effect on the Company's business, financial condition and results of
operations.
The Company recently acquired certain operations which, prior to
acquisition by the Company, involved leased premises in Cambridge, Massachusetts
in an area of past industrial activities. As a result of those past activities,
there is evidence of low levels of oil and hazardous materials at the site of
such premises. The Company believes that the level of oil and hazardous
materials at the site are typical of this and many other urban areas and that no
remediation of the site is likely to be required. However, there can be no
assurance that in the future The Commonwealth of Massachusetts or the United
States Environmental Protection Agency will not require remediation of the site
and, if remediation were required, the Company could be required to bear part of
the costs of remediation, which could be substantial.
Social Factors. The research and development efforts sponsored by the
Company involves use of laboratory animals. The Company may be adversely
affected by changes in laws, regulations or accepted clinical procedures or by
social pressures that would restrict the use of animals in testing or by actions
against the Company or its collaborators by groups or individuals opposed to
such testing.
Dependence Upon Key Personnel. The Company is dependent on the members
of its management and scientific staff, the loss of one or more of whom could
have a material adverse effect on the Company. The Company also depends on its
scientific collaborators and advisors, all of whom have commitments that may
limit their availability to the Company. In addition, the Company believes that
its future success will depend in large part upon its ability to attract and
retain highly skilled scientific, managerial and marketing personnel,
particularly as the Company expands its activities in clinical trials, the
regulatory approval process and sales and manufacturing. The Company faces
significant competition for such personnel from other companies, research and
academic institutions, government entities and other organizations. There can be
no assurance that the Company will be successful in hiring or retaining the
personnel it requires for continued growth. The failure to hire and retain such
personnel could materially and adversely affect the Company's future business,
financial condition and results of operations.
Volatility of Stock Price. The market price of the shares of the
Company's Common Stock, like that of the common stock of many other early-stage
biotechnology companies, may be highly volatile. Factors such as announcements
of technological innovations or new commercial products by the Company or its
competitors, disclosure of results of clinical testing or regulatory
proceedings, governmental regulation and approvals, developments in patent or
other proprietary rights, public concern as to the safety of products developed
by the Company and general market conditions may have a significant effect on
the market price of the Company's Common Stock. In addition, the stock market
has experienced and continues to experience extreme price and volume
fluctuations which have affected the market price of many biotechnology
companies and which have often been unrelated to the operating performance of
these companies. These broad market fluctuations, as well as general economic
and political conditions, may adversely effect the market price of the Company's
Common Stock. Future sales of the Company's
9
Common Stock in the public market by existing stockholders also could have an
adverse effect on the price of the Company's Common Stock.
THE COMPANY
AVANT is a biopharmaceutical company that uses novel applications of
immunology to prevent and treat diseases caused by both the enemy within
(autoimmune diseases, cardiovascular diseases, cancer and inflammation) and the
enemy without (infectious diseases and organ transplant rejection). Each of the
Company's products address large market opportunities for which current
therapies are inadequate or non-existent.
AVANT's products derive from a broad set of complementary technologies
with the ability to inhibit the complement system, regulate T and B cell
activity, and enable the creation and delivery of preventative and therapeutic
vaccines. The Company is using these technologies to develop vaccines and
immunotherapeutics that prevent or treat disease caused by infectious organisms,
and drugs and treatment vaccines that modify undesirable activity by the body's
own proteins or cells.
Complement Inhibitors: AVANT is developing a new class of therapeutics
that inhibit the complement system, a key triggering mechanism for the
inflammatory response. Medical problems that result from excessive complement
activation represent multi-billion dollar market opportunities. These include
reperfusion injury -- the vascular and tissue damage that occurs following a
heart attack, stroke or surgical procedure where the patient's blood supply is
shut off and then restored; hyperacute or chronic organ rejection following
transplantation; acute inflammatory injury to the lungs; autoimmune diseases;
and Alzheimer's disease. In a Phase I/II trial, AVANT's first complement
product, TP10, demonstrated positive clinical efficacy and safety in patients
with reperfusion injury following lung transplantation. The Company is also in
preclinical development with a second complement inhibitor, TP20, which inhibits
neutrophils and can be targeted to specific sites.
Atherosclerosis Treatment Vaccine: AVANT is developing a novel treatment
vaccine aimed at increasing levels of high-density lipoprotein (HDL, or
so-called "good" cholesterol). Low levels of HDL are associated with an
increased risk of atherosclerosis, which in turn leads to heart disease and
stroke, among other health problems. The vaccine stimulates the production of
antibodies to cholesteryl ester transfer protein (CETP), which mediates the
balance between HDL and low-density lipoprotein (LDL, or "bad" cholesterol). In
preclinical studies, the CETP vaccine increased HDL levels and significantly
reduced atherosclerotic lesions in blood vessels as compared with an untreated
control group. AVANT plans to initiate clinical trials of its CETP vaccine
during the first half of 1999.
T Cell Regulators: Based on 15 years of research, AVANT has developed a
world-leading understanding of the T cell-mediated immune response and the
signal transduction pathways involved in its control. The T cell antigen
receptor (TCAR) program, now under development by Astra AB, aims to treat
autoimmune diseases by selectively inhibiting disease-causing immune cells
without impairing normal immune functions. Astra plans to initiate Phase II
clinical trials in multiple sclerosis with a product from this program in the
second half of 1998.
Vaccines and Immunotherapeutics: AVANT is developing both preventive
vaccines against important human pathogens, and treatment vaccines and
immunotherapeutics that fight disease by turning the immune system against
chronic viral infections, cancerous cells, or harmful proteins made by the body
itself.
Preventative Vaccines for Infectious Diseases: The Company has developed
several novel delivery technologies that address shortcomings in currently
available delivery methods as well as provide new methods of vaccine delivery.
These vaccine delivery systems, which are based on a novel polymer (Adjumer(TM)
and Micromer(TM) vaccines) have the
10
potential to improve existing injectable vaccines and to permit intranasal and
oral vaccine delivery. The Company currently has several vaccines in clinical
development on its own and with corporate partners.
Therapore(TM) Immunotherapeutics: Therapore(TM) is a proprietary
technology that uses an injectable bacterial protein system to deliver protein
and peptide antigens into human cells in order to generate potent cell-mediated
immune responses against those antigens. The Company plans to employ
Therapore(TM) to develop novel immunotherapeutics for the treatment of chronic
viral infections and cancers. AVANT expects to initiate human clinical trials of
its first Therapore(TM)-based product, a treatment vaccine for melanoma, in the
first half of 1999.
The executive offices of AVANT are located at 119 Fourth Avenue,
Needham, Massachusetts 02494, and AVANT's telephone number is (781) 433-0771.
RECENT DEVELOPMENTS
On August 21, 1998, TC Merger Corp., a wholly-owned subsidiary of the
Company, was merged with and into Virus Research Institute, Inc. ("VRI") and VRI
became a wholly-owned subsidiary of the Company. VRI is engaged in the discovery
and development of (i) systems for the delivery of vaccines and
immunotherapeutics and (ii) improved and novel vaccines for adults and children.
The combined company has three products in or scheduled to enter Phase II
clinical trials in 1998, and additional products for which clinical trials have
begun or are planned to start in 1999. The combined company has five existing
corporate partnerships that support, in part, clinical development costs for its
products. The Company expects that the merger will enhance the level of
management depth and experience, and broaden the scope of the Company's
therapeutic programs for immune and cardiovascular diseases to include
prophylactic vaccines and new, wider-ranging opportunities in
immunotherapeutics.
USE OF PROCEEDS
The Company will not receive any proceeds from the sale of the Shares by
the Selling Stockholders.
REGISTRATION RIGHTS
The registration of the Shares pursuant to the Registration Statement of
which this Prospectus is a part will discharge a portion of the Company's
obligations under the terms of a Stock Purchase Agreement dated March 20, 1998.
Pursuant to the Stock Purchase Agreement, the Company has agreed to pay
all expenses of registering the Shares (other than brokerage and underwriting
commissions, taxes of any kind and any legal, accounting and other expenses
incurred by a holder thereunder). The Company also has agreed under the Stock
Purchase Agreement to indemnify each Selling Stockholder and its officers,
directors and other affiliated persons and any person who controls any Selling
Stockholder against losses, claims, damages and expenses arising under the
securities laws in connection with the Registration Statement or this
Prospectus, subject to certain limitations. In addition, each Selling
Stockholder under the Stock Purchase Agreement severally agreed to indemnify the
Company and its respective directors, officers and any person who controls the
Company against all losses, claims, damages and expenses arising under the
securities laws insofar as such loss, claim, damage or expense relates to
information furnished to the Company by such Selling Stockholder for use in the
Registration Statement or Prospectus or an amendment or supplement thereto or
the failure by such Selling Stockholder (through no fault of the Company) to
deliver or cause to be delivered this Prospectus or
11
any amendment or supplement thereto to any purchaser of Shares covered by the
Registration Statement from such Selling Stockholder.
SELLING STOCKHOLDERS
The Shares are to be offered by and for the respective accounts of the
Selling Stockholders. The following table sets forth the name and number of
shares of Common Stock owned by each Selling Stockholder as of March 20, 1998.
The Shares offered by this Prospectus may be offered from time to time by the
Selling Stockholders. Because the Selling Stockholders may sell all, some or
none of the Shares, the Company has assumed that the Selling Stockholders will
sell all of the Shares in determining the number and percentage of shares of
Common Stock that each Selling Stockholder will own upon completion of the
offering to which this Prospectus relates. The amounts set forth below are based
upon information provided by the Selling Stockholders and are accurate to the
best knowledge of the Company.
Shares of Shares of
Common Stock Shares of Common Stock Owned
Beneficially Owned Common Stock After the Offering (2)
Selling Stockholder as of March 31, 1998 Offered Hereby Number(1) Percent (2)
- ------------------- -------------------- -------------- --------- -----------
SMALLCAP World Fund, Inc..................... 1,500,000 200,000 1,300,000 4.6%
Lombard Odier & Cie.......................... 1,053,631 1,052,631 1,000 *
Lindfield Management Inc. ................... 353,469 353,469 0 *
Pierre Alan Mathier.......................... 317,036 317,036 0 *
Sequest Foundation........................... 35,191 35,191 0 *
Anisfield Investments, Ltd................... 10,167 10,167 0 *
Total........................................ 3,269,494 1,968,494 1,301,000 4.6%
- -----------------
* Less than 1%.
(1) Assumes that all Shares hereby offered by the Selling Stockholders are sold.
(2) Based on 28,461,483 outstanding shares of Common Stock of the Company as of
June 30, 1998.
PLAN OF DISTRIBUTION
This prospectus relates to the offer and sale from time to time of up to
an aggregate of 1,433,750 shares of the Company's Common Stock by the Selling
Stockholder, or by pledgees, donees, transferees or other successors in interest
thereto. The Company is registering the Shares pursuant to the Company's
obligations under a settlement agreement with the Selling Stockholder, but the
registration of the Shares does not necessarily mean that any of the Shares will
be offered or sold by the Selling Stockholder hereunder. The Company will not
receive any proceeds from the offering of the Shares by the Selling Stockholder.
The distribution of the Shares may be effected from time to time in one
or more underwritten transactions at a fixed price or prices, which may be
changed, or at market prices prevailing at the time of sale, at prices related
to such prevailing market prices or at negotiated prices. Any such underwritten
offering may be on a "best efforts" or a "firm commitment" basis. In connection
with any such underwritten offering, underwriters or agents may receive
compensation in the form of discounts, concessions or commissions from the
Selling Stockholder. Underwriters may sell the Shares to or through dealers, and
such dealers may receive compensation in the form of discounts, concessions or
commissions from the underwriters and/or commissions from the purchasers for
whom they may act as agents.
The Selling Stockholder and any underwriters, dealers or agents that
participate in the distribution of the Shares may be deemed to be "underwriters"
within the meaning of the Securities Act, and any profit on the sale of the
Shares by them
12
and any discounts, commissions or concessions received by any such underwriters,
dealers or agents might be deemed to be underwriting discounts and commissions
under the Securities Act.
At a time a particular offer of Shares is made by the Selling
Stockholder, a Prospectus Supplement, if required, will be distributed that will
set forth the name and names of any underwriters, dealers or agents and any
discounts, commissions and other terms constituting compensation from the
Selling Stockholder and any other required information.
The sale of Shares by the Selling Stockholder may also be effected from
time to time by selling Shares directly to purchasers or to or through
broker-dealers. In connection with any such sale, any such broker-dealer may act
as agent for the Selling Stockholder or may purchase from the Selling
Stockholder all or a portion of the Shares as principal, and may be made
pursuant to any of the methods described below. Such sales may be made on the
Nasdaq National Market or other exchanges on which the Common Stock is then
traded, in the over-the-counter market, in negotiated transactions or otherwise
at prices and at terms then prevailing or at prices related to the then-current
market prices or at prices otherwise negotiated.
The Shares may also be sold in one or more of the following
transactions: (a) block transactions (which may involve crosses) in which a
broker-dealer may sell all or a portion of such shares as agent but may position
and resell all or a portion of the block as principal to facilitate the
transaction; (b) purchases by any such broker-dealer as principal and resale by
such broker-dealer for its own account pursuant to a Prospectus Supplement; (c)
a special offering, an exchange distribution or a secondary distribution in
accordance with applicable Nasdaq National Market or other stock exchange rules;
(d) ordinary brokerage transactions and transactions in which any such
broker-dealer solicits purchasers; (e) sales "at the market" to or through a
market maker or into an existing trading market, on an exchange or otherwise,
for such shares; and (f) sales in other ways not involving market makers or
established trading markets, including direct sales to purchasers. In effecting
sales, broker-dealers engaged by the Selling Stockholder may arrange for other
broker-dealers to participate. Broker-dealers will receive commissions or other
compensation from the Selling Stockholder in amounts to be negotiated
immediately prior to the sale that will not exceed those customary in the types
of transactions involved. Broker-dealers may also receive compensation from
purchasers of the Shares which is not expected to exceed that customary in the
types of transactions involved.
In order to comply with the securities laws of certain states, if
applicable, the Shares may be sold only through registered or licensed brokers
or dealers. In addition, in certain states, Shares may not be sold unless they
have been registered or qualified for sale in such state or an exemption from
such registration or qualification requirement is available and is complied
with.
All expenses incident to the registration of the Shares shall be paid by
the Company. See "Registration Rights."
Insofar as indemnification for liabilities arising under the Securities
Act may be permitted to directors, officers or persons controlling the Company
pursuant to the foregoing provisions, the Company has been informed that in the
opinion of the Commission such indemnification is against public policy as
expressed in the Securities Act and is, therefore, unenforceable.
LEGAL MATTERS
The validity of the issuance of the Shares offered hereby will be passed
upon for the Company by its counsel, Goodwin, Procter & Hoar LLP, Boston,
Massachusetts.
13
EXPERTS
The consolidated financial statements of AVANT Immunotherapeutics, Inc.
(formerly T Cell Sciences, Inc.) incorporated in this Prospectus by reference to
the Annual Report on Form 10-K for the year ended December 31, 1997 have been so
incorporated in reliance upon the report of PricewaterhouseCoopers LLP,
independent accountants, given on the authority of said firm as experts in
auditing and accounting.
The financial statements of Virus Research Institute, Inc. as at
December 31, 1997 and 1996 incorporated by reference in this Form S-3 have been
audited by Richard A. Eisner & Company, LLP, independent auditors, as set forth
in their report thereon and are incorporated by reference herein in reliance
upon such report given upon the authority of said firm as experts in accounting
and auditing.
14
===============================================================================
No dealer, sales representative or any other 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 information or representations must not be relied upon as having been
authorized by the Company or any other person. This Prospectus does not
constitute an offer to sell or a solicitation of an offer to buy any securities
other than the shares of Common Stock to which it relates or an offer to, or a
solicitation of, any person in any jurisdiction where such an offer or
solicitation would be unlawful. 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 or that information
contained herein is correct as of any time subsequent to the date hereof.
---------------------------
TABLE OF CONTENTS
---------------------------
Page
Available Information....................................................... 2
Incorporation of Certain Documents by Reference............................. 2
Risk Factors................................................................ 3
The Company................................................................. 10
Recent Developments......................................................... 11
Use of Proceeds............................................................. 11
Registration Rights......................................................... 11
Selling Stockholders........................................................ 12
Plan of Distribution........................................................ 12
Legal Matters............................................................... 13
Experts..................................................................... 14
---------------------------
===============================================================================
===============================================================================
1,968,494 Shares
AVANT
IMMUNOTHERAPEUTICS,
INC.
COMMON STOCK
----------------------
PROSPECTUS
----------------------
September 30, 1998
===============================================================================
Part II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution. (1)
The following are the estimated expenses of the distribution of the
Shares registered hereunder on Form S-3:
SEC Registration Fee........................................................ $ 1,706
Legal Fees and Expenses..................................................... 20,000
Placement Fees & Expenses................................................... 182,655
------------
Total................................................................. $ 204,361
===========
(1) The amounts set forth above, except for the SEC Registration Fee, are
estimated.
Item 15. Indemnification of Directors and Officers.
The Company is a Delaware corporation. Reference is made to Section 145
of the Delaware General Corporation Law (the "DGCL"), which enables a
corporation to eliminate or limit the personal liability of a director for
monetary damages for violations of the director's fiduciary duty, except for
liability (i) for any breach of the director's duty of loyalty to the Company,
(ii) for acts or omissions not in good faith or which involve intentional
misconduct or a knowing violation of law, (iii) under Section 145 or (iv) for
any transaction from which a director derived an improper personal benefit. The
Company has adopted such provisions in the Company's Amended and Restated Bylaws
(the "Bylaws").
The DGCL permits, but does not require, a corporation to indemnify its
directors, officers, employees or agents and expressly provides that the
indemnification provided for under the DGCL shall not be deemed exclusive of any
indemnification right under any bylaw, vote of stockholders or disinterested
directors, or otherwise. The DGCL permits indemnification against expenses and
certain other liabilities arising out of legal actions brought or threatened
against such persons for their conduct on behalf of the corporation, provided
that each such person acted in good faith and in a manner that he or she
reasonably believed was in or not opposed to the corporation's best interests
and in the case of a criminal proceeding, had no reasonable cause to believe his
or her conduct was unlawful. The DGCL does not allow indemnification of
directors in the case of an action by or in the right of the corporation
(including stockholder derivative suits) unless the directors successfully
defend the action or indemnification is ordered by the court. The Bylaws of the
Company provide for indemnification to the fullest extent authorized by the DGCL
and, therefore, these statutory indemnification rights are available to the
directors, officers, employees and agents of the Companies. Insofar as
indemnification for liabilities arising under the Securities Act of 1933, as
amended (the "Securities Act") may be permitted to directors and officers of the
Company pursuant to the foregoing provision or otherwise, the Company has been
advised that, in the opinion of the Commission, such indemnification is against
public policy as expressed in the Securities Exchange Act of 1934, as amended
(the "Exchange Act"), and is therefore, unenforceable.
The Company currently carries a directors' and officers' liability
insurance policy which provides for payment of expenses of the Company's
directors and officers in connection with threatened, pending or completed
actions, suits or proceedings against them in their capacities as directors and
officers, in accordance with the Bylaws and the DGCL.
II-1
Item 16. Exhibits.
Exhibit
No. Description
4.1 Form of Stock Purchase Agreements dated as of March 20, 1998, between the Company and the Selling
Shareholders*
5.1 Opinion of Goodwin, Procter & Hoar LLP**
23.1 Consent of PricewaterhouseCoopers LLP**
23.2 Consent of Richard A. Eisner & Company, LLP**
23.3 Consent of Goodwin, Procter & Hoar LLP (included in Exhibit 5.1)
24.1 Power of Attorney*
- ---------
* Previously filed.
** Filed herewith.
Item 17. Undertakings.
(a) The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being
made, a post-effective amendment to this Registration Statement:
(i) To include any prospectus required by Section 10(a)(3) of
the Securities Act;
(ii) To reflect in the prospectus any facts or events arising
after the effective date of the Registration Statement (or
the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental
change in the information set forth in the Registration
Statement. Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the total
dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or
high and of the estimated maximum offering range may be
reflected in the form of prospectus filed with the
Commission pursuant to Rule 424(b) if, in the aggregate,
the changes in volume and price represent no more than a 20
percent change in the maximum aggregate offering price set
forth in the "Calculation of Registration Fee" table in the
effective registration statement.
(iii) 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.
provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) do not
apply if the Registration Statement is on Form S-3, Form S-8 or Form
F-3, and the information required to be included in a post-effective
amendment by those paragraphs is contained in periodic reports filed
with or furnished to the Commission by the Registrant pursuant to
Section 13 or 15(d) of the Exchange Act that are incorporated by
reference in the Registration Statement.
(2) That, for the purpose of determining any liability under the
Securities Act, each such post-effective amendment shall be deemed
to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time
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) If the Registrant is a foreign issuer, to file a post-effective
amendment to the Registration Statement to include any financial
statements required by Rule 3-19 of this chapter at the start of
any delayed offering or throughout a continuous offering.
Financial statements and information otherwise required
II-2
by Section 10(a)(3) of the Securities Act need not be furnished,
provided, that the registrant includes in the prospectus, by means
of a post-effective amendment, financial statements required
pursuant to this paragraph (a)(4) and other information necessary
to ensure that all other information in the prospectus is at least
as current as the date of those financial statements.
Notwithstanding the foregoing, with respect to the registration
statements on Form F-3, a post-effective amendment need not be
filed to include financial statements and information required by
Section 10(a)(3) of the Securities Act or Rule 3-19 of this
chapter if such financial statements and information are contained
in periodic reports filed with or furnished to the Commission by
the registrant pursuant to Section 13 or Section 15(d) of the
Exchange Act that are incorporated by reference in the Form F-3.
(b) The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act, each filing of the
Registrant'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.
(c) Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers or persons
controlling the Registrant pursuant to the foregoing provisions, the
Registrant has been informed that in the opinion of the Commission
such indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable. In the event that a
claim for indemnification against such liabilities (other than the
payment by the Registrant of expenses incurred or paid by a director,
officer or controlling person of the Registrant in the successful
defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the
securities being registered, the Registrant will, unless in the
opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question
whether such indemnification by it is against public policy as
expressed in the Securities Act and will be governed by the final
adjudication of such issue.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended
the Registrant certifies that it has reasonable grounds to believe that it meets
all of the requirements for filing on Form S-3 and has duly caused this
Registration Statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in the City of Needham, Commonwealth of Massachusetts, on
September 30, 1998.
AVANT IMMUNOTHERAPEUTICS, INC.
By: /s/ Una S. Ryan
------------------------------------------
Una S. Ryan, Ph.D.
President, Chief Executive Officer and
Director
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
Signature Title Date
/s/ Una S. Ryan President, Chief Executive September 25, 1998
- ------------------------------------------------ Officer and Director
Una S. Ryan, Ph.D. (Principal Executive Officer)
/s/ Norman W. Gorin Vice President, Finance, September 30, 1998
- ------------------------------------------------ Chief Financial Officer
Norman W. Gorin and Secretary (Principal
Financial Officer and Principal
Accounting Officer)
* Director September 25, 1998
- -------------------------------------------------
Patrick C. Kung
Director September __, 1998
- ------------------------------------------------
Frederick W. Kyle
Director September __, 1998
- ------------------------------------------------
John W. Littlechild
* Director September 25, 1998
- -------------------------------------------------
Harry H. Penner, Jr.
II-4
* Director September 25, 1998
- -------------------------------------------------
Thomas R. Ostermueller
Director September __, 1998
- ------------------------------------------------
J. Barrie Ward
* By Una S. Ryan, Ph.D. as Attorney-in-Fact
/s/ Una S. Ryan
- --------------------------------------
Una S. Ryan, Ph.D.
II-5
EXHIBIT INDEX
Exhibit
Number Description
4.1 - Form of Stock Purchase Agreement dated as of March 20, 1998, between the Company and each of
the Selling Stockholders*
5.1 - Opinion of Goodwin, Procter & Hoar LLP**
23.1 - Consent of PricewaterhouseCoopers LLP**
23.2 - Consent of Richard A. Eisner & Company, LLP**
23.3 - Consent of Goodwin, Procter & Hoar LLP (included in Exhibit 5.1)
24.1 - Power of Attorney*
- ------------
* Previously filed.
** Filed herewith.
EXHIBIT 5.1
[Letterhead of Goodwin, Procter & Hoar LLP]
September 30, 1998
AVANT Immunotherapeutics, Inc.
119 Fourth Avenue
Needham, Massachusetts 02194
Ladies and Gentlemen:
This opinion is furnished in our capacity as counsel to AVANT
Immunotherapeutics, Inc., a Delaware corporation (the "Company"), in connection
with the registration, pursuant to the Securities Act of 1933 (the "Securities
Act"), of 1,968,494 shares (the "Shares") of common stock, par value $.001 per
share, of the Company.
In connection with rendering this opinion, we have examined the
Certificate of Incorporation and the Bylaws of the Company, each as amended to
date; such records of the corporate proceedings of the Company as we have deemed
material; a registration statement on Form S-3 under the Securities Act relating
to the Shares and the prospectus contained therein; and such other certificates,
receipts, records and documents as we considered necessary for the purposes of
this opinion.
We are attorneys admitted to practice in the Commonwealth of
Massachusetts. We express no opinion concerning the laws of any jurisdiction
other than the laws of the United States of America and the Commonwealth of
Massachusetts and the Delaware General Corporation Law.
Based upon the foregoing, we are of the opinion that the Shares are duly
authorized, legally issued, fully paid and nonassessable by the Company under
the Delaware General Corporation Law.
The foregoing assumes that all requisite steps will be taken to comply
with the requirements of the Securities Act and applicable requirements of state
laws regulating the offer and sale of securities.
We hereby consent to the filing of this opinion as an exhibit to the
Registration Statement and to the reference to our firm under the caption "Legal
Matters" in the Prospectus.
Very truly yours,
/s/ GOODWIN, PROCTER & HOAR LLP
EXHIBIT 23.1
Consent of Independent Accountants
We hereby consent to the incorporation by reference in the Prospectus
constituting part of this Registration Statement on Form S-3 (No. 333-56755) of
AVANT Immunotherapeutics, Inc. (formerly T Cell Sciences, Inc.) of our report
dated March 25, 1998 appearing in the Annual Report on Form 10-K for the year
ended December 31, 1997. We also consent to the reference to us under the
heading "Experts" in such Prospectus.
/s/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
Boston, Massachusetts
September 29, 1998
EXHIBIT 23.2
INDEPENDENT AUDITORS' CONSENT
We consent to the inclusion in this post effective Amendment No. 1 on Form S-3
(File No. 333-56755) of our report dated January 30, 1998 on our audits of
Virus Research Institute, Inc. as of December 31, 1997 and 1996 and for each of
the years in the three-year period ended December 31, 1997 and for the period
February 11, 1991 (inception) through December 31, 1997. We also consent to the
reference to our firm under the caption "Experts."
/s/ Richard A. Eisner & Company, LLP
New York, New York
September 28, 1998
