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As filed with the Securities and Exchange Commission on December 20, 1999
REGISTRATION STATEMENT NO. 333-89341
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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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)
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DELAWARE 13-3191702
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification No.)
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119 FOURTH AVENUE
NEEDHAM, MASSACHUSETTS 02494
(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 02494
(781) 433-0771
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
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Copy to:
STUART M. CABLE, P.C.
ETTORE A. SANTUCCI, P.C.
GOODWIN, PROCTER & HOAR LLP
EXCHANGE PLACE
BOSTON, MASSACHUSETTS 02109-2881
(617) 570-1000
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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 used 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 SAID SECTION 8(A),
MAY DETERMINE.
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The information in this prospectus is not complete and may be changed. These
securities may not be sold until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an offer
to sell these securities and it is not soliciting an offer to buy these
securities in any state where the offer or sale is not permitted.
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SUBJECT TO COMPLETION. DATED DECEMBER 20, 1999.
PROSPECTUS
5,459,375 SHARES OF COMMON STOCK
AVANT IMMUNOTHERAPEUTICS, INC.
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The selling stockholders named on page 12 are selling 5,459,375 shares of
our common stock. Our common stock is listed on the Nasdaq National Market
System under the symbol "AVAN." On December 17, 1999, our common stock closed at
a price of $1.75 per share.
SEE "RISK FACTORS" BEGINNING ON PAGE 2 FOR IMPORTANT FACTORS YOU SHOULD
CONSIDER BEFORE YOU INVEST IN OUR COMMON STOCK.
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NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES, OR DETERMINED IF
THIS PROSPECTUS IS TRUTHFUL OR COMPLETE. IT IS ILLEGAL FOR ANY PERSON TO TELL
YOU OTHERWISE.
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The date of this prospectus is December , 1999.
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TABLE OF CONTENTS
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PROSPECTUS SUMMARY.......................................... 1
RISK FACTORS................................................ 2
Our therapeutic products are in various stages of product
development and there are many uncertainties relating to
clinical trials and regulatory approvals that may hinder
each product's eventual development..................... 2
Our history of losses and uncertainty of our future
profitability makes the common stock a highly
speculative investment.................................. 3
We will continue to need substantial additional funds
which we will likely try to raise through sales of
capital stock that will dilute our current stockholders,
if we can raise additional funds at all................. 3
Our clinical tests may be delayed or cancelled because we
rely on third parties to plan, conduct, and monitor them
and to provide supplies for them........................ 3
The licensing, development and commercialization of some
of our products depends greatly on third-party
collaborators that may breach their agreements with us
or otherwise not use their best efforts to promote our
products................................................ 3
Some of the technology we use in product development that
is licensed from others presents the risk that the
licensor will curtail or otherwise limit our usage of
it...................................................... 4
We lack manufacturing capabilities and we will depend on
the manufacturing capabilities of others to produce our
products................................................ 4
Most of our products require governmental approvals for
commercialization which we do not have and do not expect
to obtain for several years............................. 4
In the United States, the Food and Drug Administration
product approval process is difficult and time consuming
which may delay the commercialization of our
products................................................ 5
We may face delays, difficulties or unanticipated costs in
establishing the sales and distribution capabilities
necessary to gain market acceptance for commercially
ready products.......................................... 5
We have many competitors in our field and our technologies
may become obsolete..................................... 5
We are uncertain whether our patents and patent
applications will suffice to protect our proprietary
technology.............................................. 6
Changes in health care delivery systems in the United
States and abroad may delay or prevent our
profitability........................................... 6
Our business exposes us to substantial product liability
claims which may result in large monetary awards and
negative publicity against us........................... 7
Our business requires the use and handling of hazardous
materials............................................... 7
Many of our product candidates are tested in laboratory
animals which may be curtailed by social factors and
regulatory changes...................................... 8
We depend greatly on the intellectual capabilities and
experience of our key executives and scientists and the
loss of any of them could affect our ability to develop
our product candidates.................................. 8
The number of shares available for future sale could
negatively affect the market price of our common
stock................................................... 8
The market price of our stock is highly volatile with the
result that your investment in us may rapidly lose its
value................................................... 8
Year 2000 problems with our computers could lead to system
failures or miscalculations that could result in
disruptions of our normal business operations........... 9
WHERE YOU CAN FIND MORE INFORMATION......................... 9
INCORPORATION OF DOCUMENTS BY REFERENCE..................... 9
FORWARD-LOOKING STATEMENTS.................................. 10
USE OF PROCEEDS............................................. 10
REGISTRATION RIGHTS OF THE SELLING STOCKHOLDERS............. 10
SELLING STOCKHOLDERS........................................ 12
PLAN OF DISTRIBUTION........................................ 13
EXPERTS..................................................... 14
LEGAL MATTERS............................................... 14
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i
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PROSPECTUS SUMMARY
YOU SHOULD READ THIS ENTIRE PROSPECTUS CAREFULLY BEFORE DECIDING WHETHER TO
INVEST IN OUR COMMON STOCK.
------------------------
ABOUT AVANT IMMUNOTHERAPEUTICS, INC.
We engage in discovering, developing and commercializing, E.G.
manufacturing, marketing and selling, products that harness the human body's
immune system to prevent and treat disease.
Additional information regarding Avant, including our audited financial
statements and descriptions of our business, is contained in the documents
incorporated by reference in this prospectus. See "Where You Can Find More
Information" on page 9.
THE OFFERING
This prospectus is for up to 5,459,375 shares of common stock offered for
sale by the selling stockholders. The selling stockholders purchased these
shares in a private placement on September 22, 1999. Registering the common
stock covered by this prospectus fulfills our contractual obligations to do so.
However, it does not necessarily mean that the selling stockholders will sell
any of the common stock.
We must pay the registration expenses of the common stock under federal and
state securities laws, but we will not receive any proceeds from the sale of the
common stock.
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RISK FACTORS
YOU SHOULD CONSIDER CAREFULLY THESE RISK FACTORS TOGETHER WITH ALL OF THE
INFORMATION INCLUDED OR INCORPORATED BY REFERENCE IN THIS PROSPECTUS BEFORE YOU
DECIDE TO PURCHASE SHARES OF OUR COMMON STOCK. THIS SECTION INCLUDES SOME
FORWARD-LOOKING STATEMENTS.
OUR COMMERCIAL SUCCESS REQUIRES THE DEVELOPMENT OF OUR THERAPEUTIC PRODUCTS THAT
ARE IN VARIOUS STAGES OF TESTING AND THERE ARE MANY TESTING RELATED
UNCERTAINTIES THAT MAY HINDER EACH PRODUCT'S EVENTUAL DEVELOPMENT
WE HAVE NO COMMERCIAL REVENUES TO DATE FROM SALES OF OUR PRODUCTS AND CANNOT
PREDICT IF WE WILL
All of our products are in various stages of research and development.
Before we can commercialize them, they must pass several tests relating to their
safety and effectiveness. Moreover, we must obtain regulatory approvals and
develop successful manufacturing processes for each product. Any difficulty or
delay in commercializing our products will likely delay future revenues.
OUR PRODUCTS MAY NOT BE AS SAFE OR EFFECTIVE AS OUR TESTING INDICATES
We perform a preliminary set of tests on our products when they are at an
early stage of development. These preliminary tests, called preclinical tests,
provide information about a product's safety and effectiveness under laboratory
conditions, usually in laboratory animals. We perform another set of tests on
our products when they are in a more advanced stage of development. These
advanced tests, called clinical tests, provide information about a product's
safety and effectiveness when given to humans under appropriate medical and
regulatory supervision. A product's safety and effectiveness in preliminary
tests does not necessarily indicate its safety and effectiveness in more
advanced tests. Moreover, we may not discover all potential problems with a
product even after completing our testing on it. Some of our products and
technologies have undergone only preclinical testing. As a result, we do not
know whether they are safe or effective for humans. Also, regulatory authorities
may decide, contrary to our findings, that a product is unsafe or not as
effective in actual use as its test results indicated. This could prevent its
widespread use, require its withdrawal from the market or expose us to
liability.
CLINICAL TESTS ARE CRITICAL TO THE SUCCESS OF OUR PRODUCTS BUT ARE SUBJECT TO
UNFORESEEN AND UNCONTROLLABLE DELAY, INCLUDING DELAY IN THE ENROLLMENT OF
PATIENTS
Our ability to complete clinical testing according to schedule depends on
several factors, including how quickly we enroll patients for the tests. Many
factors affect patient enrollment, including:
- the size of the patient population
- the nature of the clinical test
- the proximity of patients to clinical sites
- the eligibility criteria for the trial
If we cannot enroll patients as planned, our costs may increase or we may
delay or terminate testing for a product.
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OUR HISTORY OF LOSSES AND UNCERTAINTY OF OUR FUTURE PROFITABILITY MAKES THE
COMMON STOCK A HIGHLY SPECULATIVE INVESTMENT
We have accumulated net operating losses since inception of approximately
$129.7 million, as of September 30, 1999. We expect to spend substantial funds
to continue research and product testing and to establish sales, marketing,
quality control, and regulatory and administrative capabilities. We may lose
money over the next several years as the number of our potential products
increases and as we expand our efforts in those areas.
We cannot predict the size or duration of any future losses. Before we earn
any profits, we must complete the development of some or all of our products,
obtain necessary regulatory approvals and successfully manufacture and market
our products. We are unlikely to make profits in the near future and are
uncertain whether we will do so at all or on a continuing basis.
WE WILL CONTINUE TO NEED SUBSTANTIAL ADDITIONAL FUNDS WHICH WE WILL LIKELY TRY
TO RAISE THROUGH SALES OF CAPITAL STOCK THAT WILL DILUTE OUR CURRENT
STOCKHOLDERS IF WE CAN RAISE ADDITIONAL FUNDS AT ALL
We may not receive additional funding on reasonable terms or at all. We
obtained most of our funding by the sale of capital stock. From our inception
through September 30, 1999, we raised approximately $86.7 million, after costs,
through the sale of capital stock. Before we commercialize any of our products,
we will need to raise more money and anticipate selling additional capital stock
to do so. Additional sales of our capital stock will likely dilute our then
current stockholders.
We also obtain funding through research grants and agreements with
commercial collaborators. However, these types of fundings are uncertain since
they are at the discretion of the organizations and companies that control the
funds. As a result, we may not receive any research grants or funds from
collaborators. If adequate funding is not available, we may limit our research
and development programs. Alternatively, we may borrow money from commercial
lenders, likely at high interest rates, which will increase the risk of your
investment in us.
OUR CLINICAL TESTS ARE SUBJECT TO DELAY AND CANCELLATION BECAUSE WE RELY ON
THIRD PARTIES TO PLAN, CONDUCT, AND MONITOR THEM AND TO PROVIDE SUPPLIES FOR
THEM
We rely on third parties, including Duke University Medical Center, The
Chicago Center for Clinical Research and SmithKline Beecham to conduct our
clinical tests. If any one of those third parties fails to perform as we expect
or if their work fails to meet regulatory standards, our testing could be
delayed, cancelled or rendered ineffective. We also depend on third parties to
provide us with suitable quantities of materials necessary for clinical tests.
If these materials are not available in suitable quantities of appropriate
quality in a timely manner, and at a feasible cost, our clinical tests will face
significant delays. Delays in our clinical tests will also delay the
commercialization of our products.
THE LICENSING, DEVELOPMENT AND COMMERCIALIZATION OF SOME OF OUR PRODUCTS DEPENDS
GREATLY ON THIRD-PARTY COLLABORATORS THAT MAY BREACH THEIR AGREEMENTS WITH US OR
OTHERWISE NOT USE THEIR BEST EFFORTS TO PROMOTE OUR PRODUCTS
We have agreements with pharmaceutical and biotechnology companies for the
licensing, development and commercialization of products based on technologies
and information that we either own or have the right to use. These companies
include: Heska Corporation, Innogenetics, Inc., Novartis Pharma AG, Pasteur
Merieux Connaught, SmithKline Beecham, and Yamanouchi Pharmaceutical. In some
cases, our collaborator assumes substantial responsibility to commercialize a
product. These agreements typically provide our collaborator with wide
discretion to make decisions about the amount and timing of resources that it
devotes to the development
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and commercialization of a product. We may sign more of these agreements in the
future. However, we cannot predict whether our collaborators will continue their
development efforts using our technologies or whether their efforts will achieve
success. In addition, many of our collaborators face the same kinds of risks and
uncertainties in their business that we face. A delay or setback to a
collaborator will, at a minimum, delay the commercialization of any affected
products, and may ultimately prevent it. If a collaborator fails to successfully
develop any one of our products, we will need to find another collaborator to do
so. Our search for a new collaborator will depend on our legal right to do so at
the time and whether the product remains commercially viable.
Some of our collaborative agreements are for products that are in the early
stages of research and development. Other agreements require us to decide with
our collaborators whether it is feasible to develop a particular product using
our technologies. In each case, these agreements may terminate without benefit
to us if the underlying products are not fully developed. Moreover, once we or
the collaborators chose specific products for development, the agreements
relating to them may require us to negotiate additional licenses and other
agreements on presently uncertain but potentially unfavorable terms. Also, our
collaborators may choose to pursue alternative technologies or products that
compete with our technologies or products. The collaborative agreements may also
require us to meet specified milestones or to invest money and other resources
in the development process, neither of which, at the time, is possible or
practicable. If we fail to meet our obligations under those agreements, they
could terminate. And, if that occurs, we would probably need to enter into
relationships with other collaborators and to spend additional time, money, and
other valuable resources in the process.
SOME OF THE TECHNOLOGY WE USE IN PRODUCT DEVELOPMENT THAT IS LICENSED FROM THIRD
PARTIES PRESENTS THE RISK THAT THE LICENSOR WILL CURTAIL OR OTHERWISE LIMIT OUR
USAGE OF IT
The terms of these licenses may obligate us to exercise diligence, achieve
milestones or devote minimum amounts of resources in bringing potential products
to market. They may also obligate us to make royalty and milestone payments,
including a percentage of any sublicensing income, as well as patent cost
reimbursement payments. If we fail to perform our obligations fully, the
licensor can terminate the licenses or make them non-exclusive, and we may lose
our right to market and sell any products based on the licensed technology. We
cannot predict our ability to meet our obligations under these licenses.
Furthermore, we may need to obtain licenses to additional technologies for some
of our products under development and, if we cannot obtain any required
licenses, we may lose our ability to commercialize the products.
WE LACK MANUFACTURING CAPABILITIES AND WE WILL DEPEND ON THE MANUFACTURING
CAPABILITIES OF OTHERS TO PRODUCE OUR PRODUCTS
For successful commercialization, our products will require manufacturing in
adequate quantities, in compliance with regulatory requirements, and at a
competitive cost. We may not find third parties capable of meeting those
manufacturing needs. Moreover, since we would not directly control the
manufacturing process, we expect to have a limited ability to monitor the
process and detect problems. If third parties cannot meet our manufacturing
needs, we will face delay and additional costs while we develop internal
manufacturing capabilities.
MOST OF OUR PRODUCTS REQUIRE GOVERNMENTAL APPROVALS FOR COMMERCIALIZATION WHICH
WE DO NOT HAVE AND DO NOT EXPECT TO OBTAIN FOR SEVERAL YEARS
Our products and our research and development and testing programs are
extensively regulated by governmental authorities in the United States and other
countries. The regulatory process, which includes all phases of testing, is
expensive and often takes many years. Data obtained from product tests are
susceptible to varying interpretations which could delay, limit or
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prevent regulatory approval. Moreover, during the regulatory process, new or
changed drug approval policies may cause unanticipated delays or rejection of
our products. We may not obtain necessary regulatory approvals within a
reasonable period of time, if at all, or avoid delays or other problems in
testing our products. Even if we receive regulatory approval for a product, the
approval may require limitations on use, which would restrict the size of the
potential market for the product.
After regulatory approval is obtained, a product and its manufacturer are
subject to continuing review and periodic inspections of manufacturing
facilities. Subsequent discovery of previously unknown problems with a product
or its manufacturing process may result in restrictions on the product or the
manufacturer, including withdrawal of the product from the market. Failure to
comply with the applicable regulatory requirements can result in fines,
suspensions of regulatory approvals, product recalls, operating restrictions and
criminal prosecution.
IN THE UNITED STATES, THE FOOD AND DRUG ADMINISTRATION PRODUCT APPROVAL PROCESS
IS DIFFICULT AND TIME CONSUMING WHICH MAY DELAY THE COMMERCIALIZATION OF OUR
PRODUCTS
Our products require FDA approval of our testing procedures. We must sponsor
and file a new drug application for each proposed product. We must also initiate
and oversee the clinical tests to demonstrate the safety and effectiveness
necessary to obtain FDA approval. The FDA historically takes several years to
process license applications. If the FDA determines that an application is
incomplete, or that the data submitted fails to answer important issues,
approval times may increase significantly. The FDA may ultimately decide that
the license application does not satisfy its criteria for approval.
WE MAY FACE DELAYS, DIFFICULTIES OR UNANTICIPATED COSTS IN ESTABLISHING THE
SALES AND DISTRIBUTION CAPABILITIES NECESSARY TO GAIN MARKET ACCEPTANCE FOR
COMMERCIALLY READY PRODUCTS
We currently lack sales, distribution and marketing capabilities for our
products in development. We are inexperienced in the marketing and distribution
of commercial products. To market any of our products directly, we must develop
a substantial marketing and sales force with technical expertise and a
supporting distribution capability. We may choose or find it necessary to enter
into strategic partnerships on uncertain but potentially unfavorable terms to
sell, market and distribute our products.
WE HAVE MANY COMPETITORS IN OUR FIELD AND THEY MAY DEVELOP TECHNOLOGIES THAT
MAKE OURS OBSOLETE
Biotechnology, pharmaceuticals and therapeutics are rapidly evolving fields
in which scientific and technological developments are expected to continue at a
rapid pace. We have many competitors in the United States and abroad, including
pharmaceutical, biotechnology and therapeutics companies, universities, and
other private and public research institutions. Our success depends upon our
ability to develop and maintain a competitive position in the product categories
and technologies on which we focus. Many of our competitors have greater
capabilities, experience and financial resources than we do. Competition is
intense and is expected to increase as new products enter the market and new
technologies become available. Our competitors may:
- develop technologies and products that are more effective than ours and
render ours obsolete or otherwise noncompetitive
- obtain regulatory approval for products more rapidly or effectively than
we can
- obtain patent protection or other intellectual property rights that would
block our ability to develop competitive products
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WE RELY ON PATENTS, PATENT APPLICATIONS AND OTHER INTELLECTUAL PROPERTY
PROTECTIONS TO PROTECT OUR TECHNOLOGY AND TRADE SECRETS AND WE ARE UNCERTAIN
WHETHER THEY ARE SUFFICIENT TO DO SO
Our success depends in part on our ability, or, for technologies we license
from others, our licensor's ability, to obtain and maintain patent protection
for technologies that we use. Biotechnology patents involve complex legal,
scientific and factual questions and are highly uncertain. To date, there is no
consistent policy regarding the breadth of claims allowed in biotechnology
patents, particularly in regard to patents for technologies for human uses that
we use in our business. We cannot predict whether the patents we seek will
issue, or, if issued, are not later challenged or limited in scope, or will
afford effective protection against competitors with similar technology. Patents
do not offer unlimited protection. A successful challenge to the validity of any
one of our patents could result in a third party's ability to use the technology
covered by the patent. We also face the risk that others will infringe, avoid or
circumvent our patents.
IF WE OR OUR LICENSORS WERE NOT THE FIRST CREATOR OF INVENTIONS, RESTRICTIONS ON
OUR ABILITY TO USE THE UNDERLYING PRODUCTS OR TECHNOLOGIES WILL OCCUR
Patent applications in the United States are maintained in secrecy until
patents issue. Patent applications in some other countries generally are not
published until more than 18 months after filing. In addition, publication of
discoveries in scientific or patent literature often lags behind actual
discoveries. If third parties are first to invent products or technologies
similar to ours and receive patents, their patents may prevent our use of the
similar technologies or the development of the similar products without licenses
from the third parties. However, if licenses from third parties are necessary,
but are unattainable, a delay in, or the prevention of, the commercialization of
our affected products will result.
AS A BUSINESS THAT USES A SUBSTANTIAL AMOUNT OF INTELLECTUAL PROPERTY, WE FACE
HEIGHTENED RISK OF INTELLECTUAL PROPERTY LITIGATION
If we must defend against suits brought against us or prosecute suits
against others involving patent or other intellectual property rights, we will
incur substantial costs. In addition to any potential liability for significant
monetary damages, a decision against us may require us to obtain licenses to
patents or other intellectual property rights of others. In the event we must
obtain licenses from others, our ability to obtain those licenses on acceptable
terms is uncertain. Also, ongoing royalties and other costs associated with
licenses may be substantial. In the event we cannot acquire necessary licenses,
we would attempt to design around third-party patents, which is expensive and
may ultimately be impracticable.
IT IS DIFFICULT TO PROTECT THE CONFIDENTIALITY OF OUR TRADE SECRETS AGAINST
DISCOVERY BY OUR COMPETITORS
We seek to protect our proprietary technology in part by confidentiality
agreements and, if applicable, inventor's rights agreements with our
collaborators, advisors, employees and consultants. If these agreements are
breached, our competitors may discover our trade secrets. Moreover, we conduct a
significant amount of research through academic advisors and collaborators
prohibited from entering into confidentiality or inventor's rights agreements by
their academic institutions.
CHANGES IN HEALTH CARE DELIVERY SYSTEMS IN THE UNITED STATES AND ABROAD MAY
DELAY OR PREVENT OUR PROFITABILITY
In the United States and other countries, in most cases, the volume of sales
of products like ours depends in large part on the availability of reimbursement
from third-party payors. These include national health care agencies, private
health insurance plans and health maintenance organizations. Third-party payors
increasingly challenge the prices charged for medical products
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and services. Our success in generating revenues from sales of products may
depend on the availability of reimbursement from third-party payors.
Accordingly, if we succeed in bringing products to market, there is no means to
assure their cost effectiveness, the availability of reimbursement, or, if
available, that the level of reimbursement is sufficient to sell the products on
a profitable basis. If reimbursement is not available or is insufficient, the
level of market acceptance of our products will suffer significantly.
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:
- mandated basic health care benefits
- controls on health care spending through limitations on the growth of
private health insurance premiums and Medicare and Medicaid spending
- creation of large medical services and products purchasing groups
- fundamental changes to the health care delivery system
We anticipate ongoing review and assessment of alternative health care
delivery systems and methods of payment in the United States and other
countries. We cannot predict whether any particular reform initiatives will
result or, if adopted, their impact on us. We expect reform proposals will have
a negative effect on our ability to market our products at acceptable prices.
OUR BUSINESS EXPOSES US TO SUBSTANTIAL PRODUCT LIABILITY CLAIMS WHICH MAY RESULT
IN LARGE MONETARY AWARDS AND NEGATIVE PUBLICITY AGAINST US
The risk of product liability claims, product recalls and associated
negative publicity is inherent in the testing, manufacturing, marketing and sale
of medical products. We currently carry liability insurance with only limited
coverage, but may choose or find it necessary under our collaborative agreements
to increase it in the future. We cannot predict our ability to maintain our
current insurance coverage or to purchase greater or broader product liability
insurance coverage on acceptable terms or at reasonable costs when we need it.
Even if we maintain insurance coverage, our liability for mandatory damages
could exceed the amount of coverage and require us to pay a substantial monetary
award. A successful product liability claim or a product recall could generate
substantial negative publicity about our products and company and inhibit or
prevent commercialization of other products.
OUR BUSINESS REQUIRES THE USE AND HANDLING OF HAZARDOUS MATERIALS
Our research and development activities involve the controlled use of
hazardous chemicals, biological materials and radioactive compounds. Federal,
state and local laws and regulations govern the use, manufacture, storage,
handling, and disposal of hazardous materials and hazardous waste products.
Although we believe that our safety procedures for handling and disposing of
hazardous materials comply with the standards prescribed by applicable laws and
regulations, we cannot completely eliminate the risk of accidental contamination
or injury from these materials. In the event of an accident, an injured party
will likely sue us for any resulting damages with potentially significant
liability. The ongoing cost of complying with environmental laws and regulations
is significant and may increase in the future. In addition, in connection with
our merger with Virus Research Institute, Inc. in 1998, we assumed the real
property lease at Virus Research Institute, Inc.'s former site. We understand
that this property has a low level of oil-based and other hazardous material
contamination. We believe that the risks posed by this contamination are low,
but we cannot predict whether additional hazardous contamination exists at this
site, or that changes in applicable law will not require us to clean up the
current contamination of the property.
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MANY OF OUR PRODUCT CANDIDATES ARE TESTED IN LABORATORY ANIMALS, AND SOCIAL
FACTORS AND REGULATORY CHANGES MAY CURTAIL THEIR USE IN TESTING
Our research and development efforts often involve the controlled use of
laboratory animals. Opposition to this practice by domestic or foreign activist
groups such as People for the Ethical Treatment of Animals may interfere with
the use of animal testing. Negative publicity generated by activist groups may
harm companies using this practice, including us. In addition, physical force
and demonstrations may occur against us or our collaborative partners which
could delay the testing of our products. Lobbying efforts by activist groups and
other groups and individuals against the use of animals in testing is ongoing,
and may result in changes in laws, regulations or accepted clinical procedures
that would restrict the use of animals in testing. If any of these changes
occur, delays in our product development will likely result until we find other
methods for effective testing.
WE DEPEND GREATLY ON THE INTELLECTUAL CAPABILITIES AND EXPERIENCE OF OUR KEY
EXECUTIVES AND SCIENTISTS AND THE LOSS OF ANY OF THEM COULD AFFECT OUR ABILITY
TO DEVELOP OUR PRODUCT CANDIDATES
The loss of Dr. Una S. Ryan, our president and chief executive officer, or
other key members of our staff could harm us. We have employment agreements with
Dr. Ryan and one other senior executive officer. We also depend on our
scientific collaborators and advisors, all of whom have other commitments that
may limit their availability to us. In addition, we believe that our future
success will depend in large part upon our ability to attract and retain highly
skilled scientific, managerial and marketing personnel, particularly as we
expand our activities in clinical trials, the regulatory approval process and
sales and manufacturing. We face significant competition for this type of
personnel from other companies, research and academic institutions, government
entities and other organizations. We cannot predict our success in hiring or
retaining the personnel we require for continued growth.
FUTURE SALES OF OUR COMMON STOCK IN THE PUBLIC SECURITIES MARKETS, AND THE
PERCEPTION IN THE MARKET THAT THESE SALES MAY OCCUR, COULD LOWER THE TRADING
PRICE OF OUR COMMON STOCK.
In the past several years we sold a substantial amount of our common stock
in private placement transactions. The purchasers of this common stock may sell
it in the public securities markets over time under registration rights granted
to them under the Securities Act of 1933. Additional sales of common stock
reserved under our employee benefit and other incentive plans, including stock
options, may also occur in the public securities markets.
THE MARKET PRICE OF OUR STOCK IS HIGHLY VOLATILE WITH THE RESULT THAT YOUR
INVESTMENT IN US MAY RAPIDLY LOSE ITS VALUE
Factors that may have a significant negative effect on the market price of
our common stock include:
- announcements of technological innovations or new commercial products by
us or our competitors
- disclosure of unsuccessful results of clinical testing, regulatory
proceedings, or governmental approvals
- negative developments in patent or other proprietary rights
- public concern as to the safety of products developed by us
8
<PAGE>
- general economic and market conditions
In addition, the stock market often experiences extreme price and volume
fluctuations, which affect the market price of many biotechnology companies and
which are often unrelated to the operating performance of these companies.
YEAR 2000 PROBLEMS WITH OUR COMPUTERS COULD LEAD TO SYSTEM FAILURES OR
MISCALCULATIONS THAT COULD RESULT IN DISRUPTIONS OF OUR NORMAL BUSINESS
OPERATIONS
The Year 2000 issue relates to how computer systems and programs will
recognize and process dates after December 31, 1999. Most computer systems and
programs that use two digits to specify a year, if not modified prior to the
year 2000, will not properly recognize dates. The Year 2000 issue can also
affect embedded technology systems and programs on which our business relies.
WHERE YOU CAN FIND MORE INFORMATION
We must comply with the informational requirements of the Securities
Exchange Act of 1934 and we are required to file reports and proxy statements
and other information with the Securities and Exchange Commission. You may read
and copy these reports, proxy statements and information at the public reference
facilities maintained by the Securities and Exchange Commission at Judiciary
Plaza, 450 Fifth Street, N.W., Room 1024, Washington, D.C. 20549, and at the
Securities and Exchange Commission's Regional Offices at 7 World Trade Center,
13th Floor, New York, New York 10048, and Citicorp Center, 500 W. Madison
Street, Suite 1400, Chicago, Illinois 60661-2511. You may also obtain copies at
the prescribed rates from the Public Reference Section of the Securities and
Exchange Commission at its principal office in Washington, D.C. You may call the
Securities and Exchange Commission at 1-800-SEC-0330 for further information
about the public reference rooms. The Securities and Exchange Commission
maintains a web site that contains reports, proxy and information statements and
other information regarding registrants, including, Avant, that file
electronically with the Securities and Exchange Commission. You may access the
Securities and Exchange Commission's web site at http://www.sec.gov.
INCORPORATION OF DOCUMENTS BY REFERENCE
The Securities and Exchange Commission allows us to incorporate by reference
in this prospectus the information that we file with it. Incorporation by
reference means that we can disclose important information to you by referring
you to other documents that are legally considered to be part of this
prospectus, and later information that we file with the Securities and Exchange
Commission will automatically update and supersede the information in this
prospectus, any supplement and the documents listed below. We incorporate by
reference the specific documents listed below and any future filings made with
the Securities and Exchange Commission under Section 13(a), 13(c), 14, or 15(d)
of the Securities Exchange Act of 1934 until all of the shares are sold:
- our Annual Report on Form 10-K for the fiscal year ended December 31, 1998
(as amended on Form10-K/A filed on November 8, 1999)
- our Quarterly Reports on Form 10-Q for the quarters ended March 31, 1999,
June 30, 1999 (as amended on Form 10-Q/A filed on November 8, 1999), and
September 30, 1999
- our Current Report on Form 8-K filed on September 23, 1999
- the definitive Proxy Statement for our annual meeting of stockholders held
May 6, 1999
9
<PAGE>
- the description of our common stock contained in our registration
statement on Form 8-A, filed on September 22, 1986, including all
amendments and reports updating that description
We will furnish without charge to each person to whom this prospectus is
delivered, upon request, a copy of any documents incorporated by reference other
than exhibits to those documents. Requests should be addressed to: 119 Fourth
Avenue, Needham, Massachusetts 02494, Attention: Corporate Secretary (telephone
number (781) 433-0771).
You should rely only on the information incorporated by reference or
provided in this prospectus. We have not authorized anyone to provide you with
different information. You should not assume that the information in this
prospectus or the documents incorporated by reference is accurate as of any date
other than the date on the front of this prospectus or those documents.
FORWARD-LOOKING STATEMENTS
Some statements incorporated by reference or made under the caption "Risk
Factors" and elsewhere in this prospectus are "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and Section 21E
of the Securities Exchange Act of 1934. When we use the words "anticipate,"
"assume," "believe," "estimate," "expect," "intend" and other similar
expressions, they generally identify forward-looking statements. Forward-looking
statements include, for example, statements relating to development activities,
business strategy and prospects, future capital expenditures, sources and
availability of capital, governmental regulations and their effect on us and
competition.
You should exercise caution in interpreting and relying on forward-looking
statements since they involve known and unknown risks, uncertainties and other
factors which are, in some cases, beyond our control and could materially affect
our actual results, performance or achievements. Some of the factors that could
cause our actual results, performance or achievements to differ materially from
those expressed or implied by forward-looking statements include, but are not
limited to, the matters discussed under the caption "Risk Factors."
We caution you that, while forward looking statements reflect our good faith
beliefs, they are not guarantees of future performance. In addition, we disclaim
any obligation to publicly update or revise any forward-looking statement,
whether as a result of new information, future events or otherwise.
USE OF PROCEEDS
Avant will not receive any proceeds from the sale of the shares by the
selling stockholders.
REGISTRATION RIGHTS OF THE SELLING STOCKHOLDERS
The following is a summary of the material terms and provisions of the
securities purchase agreement with the selling stockholders relating to the
registration of the common stock covered by this prospectus. It may not contain
all the information that is important to you. You can access complete
information by referring to the securities purchase agreement.
Under the securities purchase agreement, we must file a registration
statement covering the sale by the selling stockholders of the common stock that
they purchased on September 22, 1999. We must use our best efforts to cause the
registration statement to be declared effective by the Securities and Exchange
Commission no later than February 18, 2000 and to keep the registration
statement continuously effective until the earlier of:
- the date on which the selling stockholders no longer hold any of the
purchased common stock or
- September 21, 2001.
10
<PAGE>
Any common stock sold by the selling stockholders pursuant to this
prospectus will not have the benefits of the registration rights provisions of
the securities purchase agreement.
We must pay all expenses of registering the common stock. We will not pay
brokerage and underwriting commissions and taxes of any kind and any legal,
accounting and other expenses incurred by the selling stockholders. We also
agreed to indemnify the selling stockholders and their officers, directors and
other affiliated persons and any person who controls any selling stockholder
against all losses, claims, damages, actions, liabilities, costs and expenses
arising under the securities laws in connection with the registration statement
or this prospectus, subject to limitations specified in the securities purchase
agreement. In addition, the selling stockholders agreed to indemnify us and our
directors, officers and any person who controls Avant against all losses,
claims, damages, actions, liabilities, costs and expenses arising under the
securities laws if they result from:
- written information furnished to us by the selling stockholders for use in
the registration statement or this prospectus or any amendments to the
registration statement or any prospectus supplements or
- breaches or alleged breaches by selling stockholders of any of their
representations, warranties, covenants, agreements or obligations under
the terms of the securities purchase agreement.
11
<PAGE>
SELLING STOCKHOLDERS
The following table provides the name and number of shares of common stock
owned by each selling stockholder as of September 30, 1999, the number of shares
of common stock covered by this prospectus and the total number of shares of
common stock which the selling stockholders will beneficially own upon
completion of this offering. The shares offered by this prospectus may be
offered from time to time by the selling stockholders named below, or by any of
their pledgees, donees, transferees or other successors in interest.
Because the selling stockholders may sell all, some or none of the shares,
we have 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 of our
knowledge. It is possible, however, that the selling stockholders may acquire or
dispose of additional shares of common stock or units from time to time after
the date of this prospectus.
<TABLE>
<CAPTION>
Shares of
Shares of Common Stock Owned
Common Stock Shares of After the Offering
Beneficially Owned Common Stock -----------------------
Selling Stockholder as of September 30, 1999 Offered Hereby Number(1) Percent
- ------------------- ------------------------ -------------- ---------- ----------
<S> <C> <C> <C> <C>
Nomura International plc(2)............. 2,604,167 2,604,167 0 0
Kleinwort Benson Holdings, Inc(3)....... 520,833 520,833 0 0
Pictet & Cie(4)......................... 520,833 520,833 0 0
Lombard Odier & Cie(5).................. 2,151,506 546,875 1,604,631 3.2
International BM Biomedicine Holdings
AG(6)................................. 975,625 390,625 585,000 1.2
Apollo Medical Partners, L.P.(7)........ 260,417 260,417 0 0
Brandon Fradd(7)........................ 15,625 15,625 0 0
Bank of New Nominees Limited(8)......... 150,000 150,000 0 1.3
Curran Capital Partners, L.P.(9)........ 768,700 150,000 618,700 0
Clarion Capital Corporation(10)......... 100,000 100,000 0 0
Clarion Partners, L.P.(10).............. 39,000 39,000 0 0
Clarion Offshore Fund LTD(10)........... 11,000 11,000 0 0
Catalyst Partners, L.P.(11)............. 1,175,000 100,000 1,075,000 2.2
Peter Sears(12)......................... 50,000 50,000 0 0
</TABLE>
- --------------------------
(1) Assumes that all shares hereby offered by the selling stockholders are sold.
(2) The selling stockholder's address is Nomura House, 1 St. Martin's-le-Grand,
London ECIA 4NP UK.
(3) The selling stockholder's address is 75 Wall Street, New York, NY 10005,
USA.
(4) The selling stockholder's address is 29, Blvd. Georges-Favon, Geneva
CH-1211, Switzerland.
(5) The selling stockholder's address is 11 Rue de la Corrateria, Geneva
CH-1204, Switzerland. Includes warrants to purchase 40,000 shares of common
stock.
(6) The selling stockholder's address is Aeschen Platz 7, PO Box 136, Basel
CH-4010 Switzerland.
(7) The selling stockholder's address is 68 Jane Street, Suite 2E New York, New
York 10014, USA. Mr. Fradd is a managing director of Apollo Medical
Partners, L.P. and he may be deemed to beneficially own the 260,417 shares
of common stock held by Apollo Medical Partners, L.P.
(8) The selling stockholder's address is 30 Cannon Street London EC4M 6XH, UK.
(9) The selling stockholder's address is 237 Park Avenue, 9th Floor, New York,
New York 10017, USA.
(10) The selling stockholder's address is 1801 East 9th Street, Suite 1120,
Cleveland, OH 44104, USA.
(11) The selling stockholder's address is 350 Park Avenue, New York, New York
10022, USA.
(12) The selling stockholder's address is 8 Paul Road, St. David, PA 19087, USA.
Mr. Sears has been a director of Avant since May, 1999.
12
<PAGE>
PLAN OF DISTRIBUTION
This prospectus relates to the possible sale from time to time of up to an
aggregate of 5,459,375 shares of common stock by the selling stockholders, or
any of their pledgees, donees, transferees or other successors in interest. We
are registering the shares due to our contractual obligation to do so under the
registration rights provisions of the securities purchase agreement, but the
registration of the shares does not necessarily mean that any of the shares will
be offered or sold by the selling stockholders.
The distribution of the shares may be 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 prevailing market
prices or at negotiated prices. Any underwritten offering may be on a "best
efforts" or a "firm commitment" basis. In connection with any underwritten
offering, underwriters or agents may receive compensation in the form of
discounts, concessions or commissions from the selling stockholders.
Underwriters may sell the shares to or through dealers, and the dealers may
receive compensation in the form of discounts, concessions or commissions from
the underwriters and commissions from the purchasers for whom they may act as
agents.
The selling stockholders and any underwriters, dealers or agents that
participate in the distribution of the shares may be deemed to be underwriters
under the Securities Act of 1933, and any profit on the sale of the shares by
them and any discounts, commissions or concessions received by any underwriters,
dealers or agents might be deemed to be underwriting discounts and commissions
under the Securities Act. At any time a particular offer of shares is made by
the selling stockholders, a prospectus supplement, if required, will be
distributed that will, where applicable:
- identify any underwriter, dealer or agent
- describe any compensation in the form of discounts, concessions,
commissions or otherwise received by each underwriter, dealer or agent and
in the aggregate to all underwriters, dealers and agents
- identify the amounts underwritten
- identify the nature of the underwriter's obligation to take the shares
- provide any other required information
Selling stockholders may sell the shares by selling them directly to
purchasers or to or through broker-dealers. In connection with any sale, any
broker-dealer may act as agent for the selling stockholders or may purchase from
the selling stockholders all or a portion of the shares as principal, and may be
made any of the methods described below. Sales may be made on the Nasdaq
National Market System or other exchanges on which our 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:
- block transactions in which a broker-dealer may sell all or a portion of
the shares as agent but may position and resell all or a portion of the
block as principal to facilitate the transaction
- purchases by any broker-dealer as principal and resale by any
broker-dealer for its own account under any supplement to this prospectus
- a special offering, an exchange distribution or a secondary distribution
in accordance with applicable Nasdaq National Market or other stock
exchange rules
13
<PAGE>
- ordinary brokerage transactions and transactions in which any
broker-dealer solicits purchasers
- sales "at the market" to or through a market maker or into an existing
trading market, on an exchange or otherwise, for the shares
- sales in other ways not involving market makers or established trading
markets, including direct sales to purchasers
Broker-dealers engaged by the selling stockholders to carry out sales may
arrange for other broker-dealers to participate. Broker-dealers will receive
commissions or other compensation from the selling stockholders 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 states where necessary to comply with applicable state securities laws,
the shares will be sold, only through registered or licensed brokers or dealers.
In addition, the shares may not be sold in some states unless they have been
registered or qualified for sale in the state or an exemption from the
registration or qualification requirement is available and is complied with.
All expenses relating to the offering and sale of the shares, other than
commissions, discounts and fees of underwriters, broker-dealers or agents, will
be paid by us.
EXPERTS
The consolidated financial statements incorporated in this prospectus by
reference to the Annual Report on Form 10-K/A for the year ended December 31,
1998, 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.
LEGAL MATTERS
The validity of the common stock we are offering will be passed upon for us
by Goodwin, Procter & Hoar LLP, Boston, Massachusetts.
14
<PAGE>
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
YOU SHOULD RELY ONLY ON THE INFORMATION CONTAINED IN THIS PROSPECTUS,
INCORPORATED HEREIN BY REFERENCE OR CONTAINED IN A PROSPECTUS SUPPLEMENT.
NEITHER WE NOR THE SELLING STOCKHOLDERS HAVE AUTHORIZED ANYONE ELSE TO PROVIDE
YOU WITH DIFFERENT OR ADDITIONAL INFORMATION. THE SELLING STOCKHOLDERS ARE NOT
MAKING AN OFFER OF THESE SECURITIES IN ANY STATE WHERE THE OFFER IS NOT
PERMITTED. YOU SHOULD NOT ASSUME THAT THE INFORMATION IN THIS PROSPECTUS, OR
INCORPORATED HEREIN BY REFERENCE, OR IN ANY PROSPECTUS SUPPLEMENT IS ACCURATE AS
OF ANY DATE OTHER THAN THE DATE ON THE FRONT OF THOSE DOCUMENTS
5,459,375 SHARES
AVANT
IMMUNOTHERAPEUTICS,
INC.
COMMON STOCK
---------------------
PROSPECTUS
---------------------
DECEMBER , 1999
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
<PAGE>
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:
<TABLE>
<S> <C>
Registration Fee--Securities and Exchange Commission........ $ 2,944.35
Accountants Fees and Expenses............................... 2,500
Blue Sky Fees and Expenses.................................. 1,500
Legal Fees and Expenses..................................... 15,000
Printing Expenses........................................... 5,000
Miscellaneous............................................... 1,500
----------
Total................................................... $28,444.35
==========
</TABLE>
- ------------------------
(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 to 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,
II-1
<PAGE>
pending or completed actions, suits or proceedings against them in their
capacities as directors and officers, in accordance with the Bylaws and the
DGCL.
ITEM 16. EXHIBITS.
<TABLE>
<CAPTION>
EXHIBIT
NO. DESCRIPTION
- --------------------- -----------
<C> <S>
*5.1 Opinion of Goodwin, Procter & Hoar LLP
23.1 Consent of PricewaterhouseCoopers LLP
*23.2 Consent of Goodwin, Procter & Hoar LLP (included in
Exhibit 5.1)
*24.1 Power of Attorney (included on signature pages)
*99.1 Securities Purchase Agreement dated as of September 17,
1999, between the Company and the Selling Stockholders
</TABLE>
- ------------------------
* previously filed
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.
II-2
<PAGE>
(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.
(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
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-3 and has duly caused this registration
statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Needham, Commonwealth of Massachusetts, on December
20, 1999.
<TABLE>
<S> <C> <C>
AVANT IMMUNOTHERAPEUTICS, INC.
BY: /s/ UNA S. RYAN, PH.D.
-----------------------------------------
Una S. Ryan, Ph.D.
President, Chief Executive Officer and
Director
</TABLE>
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
<TABLE>
<CAPTION>
SIGNATURE TITLE DATE
--------- ----- ----
<S> <C> <C>
/s/ UNA S. RYAN, PH.D. President, Chief Executive Officer
- ---------------------------------- and Director (Principal Executive December 20, 1999
Una S. Ryan, Ph.D. Officer)
* Chairman
- ---------------------------------- December 20, 1999
J. Barrie Ward, Ph.D.
* Chief Financial Officer (Principal
- ---------------------------------- Financial Officer and Principal December 20, 1999
Lisa McGillis Accounting Officer)
* Director
- ---------------------------------- December 20, 1999
Harry H. Penner, Jr.
* Director
- ---------------------------------- December 20, 1999
Peter Sears, Esq.
* Director
- ---------------------------------- December 20, 1999
Thomas R. Ostermueller
* Director
- ---------------------------------- December 20, 1999
John L. Littlechild
* Director
- ---------------------------------- December 20, 1999
Frederick W. Kyle
*By: /s/ Una S. Ryan, Ph.D.
- ----------------------------------
Attorney-in-Fact
</TABLE>
II-4
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibit
Number Description
- ------- -----------
<C> <S>
23.1 -- Consent of PricewaterhouseCoopers LLP
</TABLE>
II-5
<PAGE>
EXHIBIT 23.1
CONSENT OF INDEPENDENT ACCOUNTANTS
We hereby consent to the incorporation by reference in this Registration
Statement on Form S-3 of our report dated March 1, 1999 relating to the
financial statements which appears in Avant Immunotherapeutics, Inc.'s Annual
Report on Form 10-K/A for the year ended December 31, 1998. We also consent to
the reference to us under the heading "Experts" in such registration statement.
/s/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
Boston, Massachusetts
December 15, 1999
2
