As filed with the Securities and Exchange Commission on March 3, 2000
Registration No. 333-_______________
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
TRIMERIS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 56-1808663
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification Number)
4727 UNIVERSITY DRIVE, SUITE 100
DURHAM, NORTH CAROLINA 27707
(919) 419-6050
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
DR. DANI P. BOLOGNESI
CHIEF EXECUTIVE OFFICE AND CHIEF SCIENTIFIC OFFICER
4727 UNIVERSITY DRIVE, SUITE 100
DURHAM, NORTH CAROLINA 27707
(919) 419-6050
(Name and address, including zip code, and telephone number, including area
code, of agent for service)
-----------------
WITH A COPY TO:
JOHN B. WATKINS, ESQ.
WILMER, CUTLER & PICKERING
2445 M STREET, N.W.
WASHINGTON, D.C. 20037
(202) 663-6000
-----------------
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. [ ]
<TABLE>
<CAPTION>
CALCULATION OF REGISTRATION FEE
- -------------------------------------------- ---------------------- --------------------- --------------------- --------------------
Proposed Proposed
Title of each maximum maximum
class of securities Amount offering aggregate Amount of
to be to be price offering registration
registered registered per share (1) price fee
- -------------------------------------------- ---------------------- --------------------- --------------------- --------------------
- -------------------------------------------- ---------------------- --------------------- --------------------- --------------------
<S> <C> <C> <C> <C> <C>
Common Stock, $0.001 par value per share 1,750,000 $58.50 $102,375,000 $27,027
- -------------------------------------------- ---------------------- --------------------- --------------------- --------------------
</TABLE>
(1) Estimated pursuant to Rule 457(c) solely for the purpose of calculating
the registration fee, based upon the average of the high and low prices
per share of Trimeris common stock, par value $.001 per share, on
February 28, 2000, as reported on The Nasdaq National Market.
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 such Section 8(a),
may determine.
<PAGE>
The information in this prospectus is not complete and may be changed. We may
not sell these securities until the registration statement filed with the
Securities and Exchange Commission is declared 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.
Subject to completion, dated March 3, 2000
PROSPECTUS
1,750,000 SHARES
[Trimeris Logo]
Trimeris, Inc.
COMMON STOCK
________________
This prospectus related solely to the resale of up to an aggregate of
1,750,000 shares of common stock of Trimeris, Inc. that we sold to the selling
stockholders listed on page 13 of this prospectus on February 2, 2000 in a
private transaction. The selling stockholders may sell these shares from time to
time in transactions on The Nasdaq National Market, in the over-the-counter
market, in negotiated transactions, through put or call option transactions
relating to the shares, through short sales of shares or through a combination
of these methods. They may sell the shares at market prices prevailing at the
time of sale or at negotiated prices.
We will not receive any of the proceeds from the sale of the shares
being sold by the selling stockholders. We have agreed to bear the expenses
incurred in connection with the registration of these shares. The selling
stockholders will pay or assume brokerage commissions or similar charges
incurred in the sale of these shares of common stock.
Our common stock is traded on The Nasdaq National Market under the
symbol "TRMS." On March 2, 2000, the closing price for the common stock as
reported by Nasdaq was $60 per share.
INVESTING IN OUR COMMON STOCK INVOLVES RISKS.
SEE "RISK FACTORS" STARTING ON PAGE 5.
________________
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES OR DETERMINED IF THIS
PROSPECTUS IS COMPLETE OR TRUTHFUL. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
________________
The date of this prospectus is ______ __, 2000.
<PAGE>
<TABLE>
<CAPTION>
TABLE OF CONTENTS
PAGE
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<S> <C>
Trimeris................................................................................... 3
Risk Factors............................................................................... 5
Use of Proceeds............................................................................ 12
Selling Stockholders....................................................................... 12
Plan of Distribution....................................................................... 14
Legal Matters.............................................................................. 15
Experts.................................................................................... 15
Where You Can Find More Information........................................................ 15
Information Incorporated by Reference...................................................... 15
</TABLE>
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TRIMERIS
We are engaged in the discovery and development of a new class of
therapeutics called viral fusion inhibitors. Viral fusion is a complex process
by which viruses attach to and penetrate host cells. If a virus cannot enter a
host cell, it cannot replicate. By inhibiting the fusion process of certain
types of viruses, our products under development offer a novel mechanism of
action to treat many serious viral diseases.
Human immunodeficiency virus - Type I, or HIV, relies on fusion to
infect host cells. Currently approved anti-HIV drugs have been used in recent
years, in various combinations, to treat HIV infection. Increasingly, these
therapies are failing to adequately treat HIV infection because they can cause
severe side effects, are difficult to take and often stop suppressing HIV
replication because the virus becomes resistant to the drugs.
We believe there is a need for a new class of anti-HIV drug that:
o works by a novel mechanism of action,
o has fewer side effects than current therapies, and
o is active against strains of HIV that are resistant to
currently-approved drugs.
We believe our anti-HIV investigational drugs under development may
meet these criteria. Our lead drug, T-20, inhibits fusion of HIV with host
cells, thereby impeding replication of the virus. In August 1997, we completed a
16-patient Phase I/II clinical trial in which T-20 reduced the amount of HIV in
the patients' blood, commonly referred to as viral load, by 98% in the highest
dose group. In January 1999, we completed T20-003, a Phase II clinical trial of
T-20. Details of the structure and results of the trial are as follows:
o 75 HIV-infected adults with high viral loads who had previously
used, on average, nine currently-approved anti-HIV drugs that no
longer suppressed their HIV viral loads below detectable levels,
received T-20 therapy,
o the median maximum reduction in HIV viral load ranged from 69% to
97% across the treatment groups, and
o twice daily subcutaneous injection, which is injection of T-20
under the skin, achieved consistent levels of T-20 in the blood.
In 1999 and 2000, we presented data from T20-205, a Phase II rollover trial for
patients who had received T-20 in previous clinical trials. Details of the
structure and results of the trial are as follows:
o patients received T-20 via twice daily subcutaneous injection in
combination with other anti-HIV drugs,
o at 16 weeks, 33 of 55, or 60%, of patients responded with
significant and clinically relevant reductions of HIV viral load,
and 30% had viral load reduced to undetectable levels of less than
400 copies/microliter,
o at 32 weeks, the decline in HIV viral load remained consistent
with the decline observed at 16 weeks and the patients continued
to tolerate T-20,
o data suggest a substantial increase in human immune cells known as
CD4+ T-cells, and
o data from 16 weeks show that T-20 does not appear to produce an
immune response in the body that could compromise T-20's efficacy.
In all clinical studies to date, the most common adverse events were
mild to moderate in severity. The most frequent adverse events include injection
site reaction, headache, nausea, fever, increased energy levels, weakness,
diarrhea, and dizziness. We are unable to determine whether T-20 caused some of
these results.
In January 1999, the FDA gave T-20 "fast track" designation. This
designation is granted to products that the FDA determines may provide
significant improvement in the treatment of serious diseases and is intended to
expedite the FDA's review. We are currently conducting two other clinical trials
of T-20 and plan to commence additional trials throughout the year. We expect to
begin a pivotal trial for T-20 in mid-2000.
We are developing T-1249, our second drug in the class of HIV fusion
inhibitors. T-1249 has demonstrated potent HIV suppression in animal models and
is highly active against a wide range of HIV strains in culture. In May 1999,
the FDA gave T-1249 "fast track" designation. In July 1999, we began a 14-day
Phase I clinical trial in up to 60 HIV-infected adults. This clinical trial is
ongoing.
T-20 and T-1249 are both peptides. The manufacture of peptides
historically has been complex and expensive. We have developed a novel peptide
manufacturing process, which we believe will allow us to manufacture T-20 and
T-1249 on a large scale
3
<PAGE>
and cost-efficient basis. We have transferred the manufacturing process to four
third party contract manufacturers who have produced various quantities of T-20.
In July 1999, we announced an agreement with F. Hoffmann-La Roche, or
Roche, to develop and market T-20 and T-1249 worldwide. We will share
development expenses and profits for T-20 and T-1249 in the United States and
Canada equally with Roche. Outside of these two countries, Roche will fund all
development costs and pay us royalties on net sales of these products. Roche
paid us $10 million up front and will provide up to an additional $58 million in
cash upon achievement of developmental, regulatory and commercial milestones.
We are also pursuing research programs to develop fusion inhibitors
that target various other viruses, including respiratory syncytial virus, human
parainfluenza virus, influenza virus, hepatitis B and C viruses.
Our principal executive office is located at 4727 University Drive,
Durham, North Carolina 27707, and our telephone number is (919) 419-6050.
4
<PAGE>
RISK FACTORS
YOU SHOULD CAREFULLY CONSIDER THE RISKS DESCRIBED BELOW BEFORE MAKING
AN INVESTMENT DECISION. IF ANY OF THE FOLLOWING RISKS OCCUR, OUR BUSINESS,
FINANCIAL CONDITION AND RESULTS OF OPERATIONS COULD BE MATERIALLY ADVERSELY
AFFECTED. AS A RESULT, THE MARKET PRICE OF OUR COMMON STOCK COULD DECLINE, AND
YOU MAY LOSE ALL OR PART OF YOUR INVESTMENT.
WE ARE AN EARLY STAGE COMPANY WITH AN UNCERTAIN FUTURE.
We formed our company and began operations in January 1993.
Accordingly, we have only a limited operating history for you to evaluate our
business. There are many business risks associated with a biopharmaceutical
company in the early stage of development, such as ours. For example, we may not
be able to obtain sufficient financial, personnel and other resources to
continue to develop our product candidates. We also may not be successful in
discovering or developing any product candidates that ultimately achieve
regulatory approval or have commercial viability.
We have not yet generated any revenues from product sales or royalties.
We have never submitted a product candidate for approval by the FDA or any other
regulatory authority for commercialization. We will have to invest significant
additional time and funds in research and development and extensive clinical
trials before we can submit our product candidates for regulatory approval. Our
product candidates may never obtain regulatory approval, and therefore, may
never be commercially available.
WE HAVE NEVER MADE MONEY AND EXPECT OUR LOSSES TO CONTINUE.
We have incurred losses since we began operating. As of December 31,
1999, our accumulated deficit was approximately $63 million. Since inception, we
have spent our funds on our product development efforts, relating primarily to
the development of T-20 and T-1249. We expect that we will incur substantial
losses for the foreseeable future. We also expect our losses to significantly
increase as we expand our research and development, preclinical testing and
clinical trial efforts. We have not yet generated any revenues from product
sales or royalties. We cannot assure you that we will ever be able to generate
any such revenues or royalties or, if we generate any revenues or royalties,
that we will ever be profitable.
WE WILL NEED TO RAISE ADDITIONAL FUNDS IN THE NEAR FUTURE.
Based on our current plan, we anticipate that our existing capital
resources will be adequate to fund our capital requirements through 2000. We
believe that substantial additional funds will be required after 2000. In the
event this financing is not obtained, we will be required to delay, scale-back
or eliminate certain preclinical testing, clinical trials and research and
development programs.
We may raise these additional funds through equity or debt financings.
If we raise funds by selling equity, our stockholders' interest may be diluted.
Any debt financings may contain restrictive terms that limit our operating
flexibility. Additionally or alternatively, we may have to attempt to obtain
funds through arrangements with collaborative partners. These partners may
require us to relinquish rights to our technologies or product candidates. This
could have a material adverse effect on our business, financial condition and
results of operations.
OUR QUARTERLY OPERATING RESULTS ARE SUBJECT TO FLUCTUATIONS AND YOU SHOULD NOT
RELY ON THEM AS AN INDICATION OF OUR FUTURE RESULTS.
Our operating results are likely to fluctuate over time, due to a
number of factors, many of which are outside of our control. Some of these
factors include:
o the status and progress of our collaborative agreement with Roche,
o the status of our research and development activities,
o the progress of our product candidates through preclinical testing
and clinical trials,
o the timing of regulatory actions,
o our ability to establish manufacturing, sales, marketing and
distribution capabilities, either internally or through
relationships with third parties,
o technological and other changes in the competitive landscape,
o changes in our existing or future research and development
relationships and strategic alliances, and
o the commercial viability of our product candidates.
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<PAGE>
As a result, we believe that comparing financial results for one period
against another period is not necessarily meaningful, and you should not rely on
our results of operations in prior periods as an indication of our future
performance. Also, if our results of operations for a period deviate from the
levels expected by securities analysts and investors, it could have a material
adverse effect on the market price of our common stock.
WE ARE HEAVILY DEPENDENT ON OUR LEAD PRODUCT CANDIDATE, T-20.
T-20 is our lead product candidate. Our success will depend, to a great
degree, on the success of T-20. In particular, we must be able to:
o establish the safety and efficacy of T-20 in humans,
o obtain regulatory approvals so that we can commercialize T-20,
o establish relationships for the commercial-scale production of
T-20 at an acceptable cost and with the appropriate quality, and
o successfully market T-20 and achieve acceptance of T-20 by the
medical community, including health care providers and third-party
payors.
We may rely on our colloborative partner, Roche, in connection with
many of these matters. We may not be able to control the amount or timing of
resources that Roche may devote to these matters. If we or Roche fail to
successfully develop and commercialize T-20, our business, financial condition
and results of operations will be materially and adversely affected.
OUR SUCCESS IN COMMERCIALIZING T-20 AND T-1249 IS DEPENDENT ON OUR RELATIONSHIP
WITH ROCHE.
In July 1999, we announced an agreement with Roche, to develop and market T-20
and T-1249 worldwide. We will share development expenses and profits for T-20
and T-1249 in the United States and Canada equally with Roche. Outside of these
two countries, Roche will fund all development costs and pay royalties to us on
net sales of T-20 and T-1249. Roche paid $10 million up front and will provide
up to an additional $58 million in cash upon achievement of certain
developmental, regulatory and commercial milestones. Our reliance on Roche poses
a number of risks, including:
o Roche may not devote sufficient resources to the development or
marketing of our products;
o disagreements with Roche could lead to delays in or termination of
the development or commercialization of our products, or result in
litigation or arbitration;
o Roche has considerable discretion in electing whether to pursue
the development of any products and may pursue alternative
technologies or products either on its own or in collaboration
with our competitors;
o Roche may choose to devote fewer resources to the development and
marketing of our products than it does to products of its own
development; and
o disputes may arise in the future with respect to the ownership of
rights to technology developed with Roche.
Given these risks, there is a great deal of uncertainty regarding the success of
our collaboration with Roche. If these efforts fail, our product development or
commercialization of T-20 or T-1249 could be delayed. Any delay could have a
material adverse affect on our business, financial condition and results of
operation.
WE FACE MANY UNCERTAINTIES RELATING TO OUR HUMAN CLINICAL TRIAL RESULTS AND
CLINICAL TRIAL STRATEGY.
In order to obtain the regulatory approvals that we need to sell
commercially any of our product candidates, we must demonstrate that each
product candidate is safe and effective for use in humans for each target
indication. We attempt to demonstrate this through preclinical testing and
clinical trials for each product candidate. This is a very complex and lengthy
process. To date, we have conducted initial preclinical testing of some of our
product candidates, a Phase I/II clinical trial of T-20 that enrolled 16
patients and several Phase II clinical trials of T-20 involving over 100
patients. We have also begun a Phase I/II clinical trial of T-1249.
Because these clinical trials have been limited to a relatively small
number of patients, we cannot assure you that the results of these early
clinical trials will support further clinical trials of T-20 or T-1249. We may
not be able to demonstrate that potential product candidates that appeared
promising in preclinical testing and early clinical trials will be safe or
effective in advanced clinical trials that involve larger numbers of patients.
We also cannot assure you that the results of the clinical trials we have
conducted and still intend to conduct will support our applications for
regulatory approval. As a result, our product development programs may be
curtailed, redirected or eliminated at any time.
We may redesign, delay or cancel our preclinical testing and clinical
trials, for some or all of the following reasons:
o unanticipated, adverse or ambiguous results from our preclinical
testing or clinical trials,
6
<PAGE>
o change in the focus of our collaborative partner, Roche,
o undesirable side effects which delay or extend the trials,
o our inability to locate, recruit and qualify a sufficient number
of patients for our trials,
o difficulties in manufacturing sufficient quantities of the
particular product candidate or any other components needed for
our preclinical testing or clinical trials,
o regulatory delays or other regulatory actions,
o change in the focus of our development efforts, and
o reevaluation of our clinical development strategy.
Accordingly, our clinical trials may not commence or proceed as
anticipated. This would have a material adverse effect on our business,
financial condition and results of operations. Also, if the results of our
clinical trials or our clinical trial strategy deviates from the expectations of
securities analysts and investors, the market price of our common stock could be
adversely affected. In addition, due to uncertainties that are part of the
clinical development process, we may underestimate the costs associated with
clinical development of T-20 or T-1249. Delays or unanticipated increases in
costs of clinical development or failure to obtain regulatory approval or market
acceptance for our products could adversely affect our operating results.
HIV MAY DEVELOP RESISTANCE TO OUR DRUG CANDIDATES.
HIV is prone to genetic mutations. These mutations have produced
strains of HIV that are resistant to currently-approved therapeutics. The HIV
virus may develop similar resistance to our viral fusion inhibitor therapeutics,
including T-20 and T-1249. This could have a material adverse effect on our
business, financial condition and results of operations.
WE HAVE NO EXPERIENCE MANUFACTURING PHARMACEUTICAL PRODUCTS.
The manufacture of pharmaceutical products requires significant
expertise and capital investment. We have no experience in manufacturing
pharmaceuticals, no commercial manufacturing capacity and only have limited
experience in manufacturing process development. As a result, we have elected to
work with third-party contract manufacturers to supply quantities of T-20 and
T-1249 to be used in currently planned clinical trials. We expect to rely on
third-party manufacturers throughout the clinical and initial commercialization
phases of T-20 and T-1249 development. We may not be able to maintain
relationships with these third-party manufacturers. Our dependence on third
parties for the manufacture of products and product candidates could have a
material adverse effect on our business, financial condition and results of
operations.
WE FACE RISKS ASSOCIATED WITH MANUFACTURING T-20 AND T-1249.
Peptide-based therapeutics are difficult and expensive to manufacture.
We, and our third-party manufacturers, are currently using a novel method to
manufacture T-20. This chemical methodology is inherently complex. We may not be
able to manufacture T-20 or T-1249 on a cost-effective basis or develop an
alternative, more efficient manufacturing method for T-20, T-1249 or any of our
other peptide product candidates. In addition, commercial production of T-20
will require raw materials in amounts substantially greater than those being
used in the current manufacturing campaigns. We may not be able to obtain these
materials in sufficient quantities or on a cost-effective basis to support the
commercial manufacture of T-20. If we are unable to manufacture T-20 or T-1249
on a cost-effective basis or are unable to obtain the necessary quantities of
raw materials, our business, financial condition and results of operations will
be materially and adversely affected.
OUR BUSINESS IS BASED ON NOVEL TECHNOLOGY AND IS HIGHLY RISKY AND UNCERTAIN.
Our product development programs are based on novel technology. Our
technology platform is designed to discover product candidates which treat viral
infection by inhibiting viral fusion, a process which prevents the virus from
fusing to the cell, thereby preventing the virus from entering the cell and
replicating. We are not aware of any other approved antiviral pharmaceutical
products that target the inhibition of viral fusion. Accordingly, developing
products that use this novel approach is highly risky and uncertain. Our
products could:
o experience unanticipated developments or clinical or regulatory
delays,
o produce unexpected adverse side effects, or
o provide inadequate therapeutic effectiveness.
Any of these could slow or suspend our product development efforts. If
any of these unanticipated results occurs, it could have a material adverse
effect on our business, financial condition and results of operations.
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We may not be able to use our novel technology platform to discover and
successfully develop any commercially viable products. We may not be able to
complete our research or product development efforts for any particular product
candidate, or develop any product candidates that will prove to be safe and
effective. We may not be able to obtain the required regulatory approvals for
any products. Our development programs are subject to the risks inherent in the
development of new products using new technologies and approaches. We may
encounter unforeseen problems with these technologies or applications and
technological challenges in our research and development programs that we may
not be able to resolve.
WE ARE DEPENDENT ON THIRD-PARTY CONTRACT RESEARCH ORGANIZATIONS.
We have engaged, and intend to continue to engage, third-party contract
research organizations or Roche to perform some functions for us related to the
development of our product candidates. We typically design our clinical trials,
but rely on these contract research organizations or Roche to actually conduct
the clinical trials. The failure by the contract research organizations or Roche
to perform our clinical trials satisfactorily or their breach of their
obligations to us could delay or prevent the commercialization of our product
candidates. This would have a material adverse effect on our business, financial
condition and results of operations.
Because we rely on third-party contract research organizations and
Roche, our preclinical testing or clinical trials may not begin or be completed
on the dates we estimate for them. Any delays in our testing and trials could
delay regulatory approval for or commercialization of our product candidates.
These delays could:
o increase our operating expenses,
o cause us to need additional capital,
o divert management's time and attention, and
o create adverse market perception about us and our product
candidates.
WE HAVE NO SALES, MARKETING OR DISTRIBUTION CAPABILITIES.
We have no experience in sales, marketing or distribution of
pharmaceuticals. We may develop these capabilities in certain areas in the
future. We may rely on Roche or other arrangements with third parties which have
established distribution systems and direct sales forces for the sales,
marketing and distribution of products. In the event that Roche does not market
our product candidates or we are unable to reach agreement with one or more
marketing partners, we may be required to develop internal sales, marketing and
distribution capabilities. We may not be able to establish cost-effective sales,
marketing or distribution capabilities or make arrangements with third parties
to perform these activities on acceptable terms, if at all. This would have a
material adverse effect on our business, financial condition and results of
operations.
If we establish sales, marketing or distribution arrangements with
other parties, they may have significant control over important aspects of the
commercialization of our products including:
o market identification,
o marketing methods,
o pricing,
o composition of sales force, and
o promotional activities.
We may not be able to control the amount or timing of resources that
any third party may devote to our products.
OUR STOCK PRICE IS HIGHLY VOLATILE.
Our stock price has fluctuated substantially since our initial public
offering, which was completed in October 1997. The market price of our common
stock, like that of the securities of many other biotechnology and
pharmaceutical companies, is likely to remain highly volatile.
Furthermore, the stock market has from time to time experienced extreme
price and volume fluctuations that may be unrelated to the operating performance
of particular companies. In addition, in the past, class action lawsuits have
often been instituted against biotechnology and pharmaceutical companies
following periods of volatility in the market price of these companies' stock.
If litigation were instituted against us on this basis, it could result in
substantial costs and would divert management's attention and resources. This
would have a material adverse effect on our business, financial condition and
results of operations.
WE DEPEND ON COLLABORATIONS AND LICENSES WITH OTHERS.
We may enter into license, development, or other agreements with Roche,
new partners or collaborators to assist us in:
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o seeking regulatory approval for our product candidates, and
o developing, manufacturing and commercializing some of our product
candidates.
Accordingly, our success will depend, in part, on our partners' success
in:
o performing preclinical testing and clinical trials,
o obtaining the requisite regulatory approvals,
o scaling up manufacturing,
o successfully commercializing the product candidates we license to
them, and
o otherwise performing their obligations.
We may not be able to maintain our existing collaborative arrangement
with Roche or enter into arrangements in the future on terms that are acceptable
to us. Moreover, Roche may not perform its obligations under our agreement with
it and may choose to compete with us by seeking alternative means of developing
therapeutics for the diseases we have targeted. In addition, we may not be able
to:
o obtain proprietary rights, or licenses under the proprietary
rights which belong to others, for any technology or product
candidates developed through this arrangement, or
o protect the confidentiality or prevent the disclosure of any
proprietary rights and information developed in our collaborative
arrangement.
We currently have an agreement with Duke University pursuant to which
we have received an exclusive, worldwide, royalty-free license to certain
discoveries and inventions, including patent rights, in the field of antiviral
therapeutics that have been developed by certain researchers at Duke University.
The license for the Duke inventions, including T-20, terminates upon the
last-to-expire patent covering such inventions. Duke University may terminate
the agreement if we fail to perform our obligations under the agreement, which
include pursuing the development of the technologies licensed to us, or if we
engage in fraud, willful misconduct or illegal conduct. If Duke University were
to terminate the agreement, we would lose our license granted under that
agreement. This would have a material and adverse effect on our business,
financial condition and results of operations.
In the future, we may find that we need additional licenses from these
or other parties to effectively develop potential product candidates. We may not
be able to maintain our existing license agreements or obtain additional
licenses on acceptable terms.
THERE IS UNCERTAINTY RELATING TO THIRD-PARTY REIMBURSEMENT AND HEALTH CARE
REFORM MEASURES WHICH COULD LIMIT THE AMOUNT WE WILL BE ABLE TO CHARGE FOR OUR
PRODUCTS.
In the United States and elsewhere, sales of prescription drugs are
dependent, in part, on the consumer's ability to be reimbursed for the cost of
the drugs by third-party payors, such as government agencies and private
insurance plans. Third-party payors are increasingly challenging the prices
charged for medical products and services in an effort to promote cost
containment measures and alternative health care delivery systems. As a result,
third-party payor reimbursements may not be available or may not be available at
a level that will allow us or our potential collaborative partners to sell our
products on a competitive basis.
Economic, political and regulatory influences, including the efforts of
governments and third-party payors to contain or reduce the cost of health care
through various means, will continue to affect the business and financial
condition of pharmaceutical companies. A number of legislative and regulatory
proposals aimed at changing the health care system have been proposed in recent
years. Because of the high cost of the treatment of HIV, many state legislatures
are reassessing reimbursement policies for this therapy. In addition, an
increasing emphasis in the United States to reduce the overall costs of health
care through managed care has and will continue to increase the pressure on
pharmaceutical pricing. We cannot predict whether legislative or regulatory
proposals will be adopted or the effect that those proposals or managed care
efforts may have. However, there is a risk that the announcement and/or adoption
of these types of proposals or efforts could have a material adverse effect on
our business, financial condition and results of operations.
THERE IS UNCERTAINTY REGARDING PATENTS AND PROPRIETARY RIGHTS.
Our success will depend, in part, on our ability and the ability of our
licensors to obtain and to keep protection for our products and technologies
under the patent laws of the United States and other countries, so that we can
prevent others from using our inventions. Our success also will depend on our
ability to prevent others from using our trade secrets. In addition, we must
operate in a way that does not violate the patent, trade secret, or other
intellectual property rights of other parties.
The pharmaceutical and biotechnology industries place considerable
importance on obtaining and maintaining patent and trade secret protection for
new technologies, products and processes. We have obtained rights to certain
patents and patent applications and may, in the future, seek rights from third
parties to additional patents and patent applications.
9
<PAGE>
The standards used by the U.S. Patent and Trademark Office and the
patent offices of other countries to grant patents may change. Consequently, we
cannot be certain as to the type and extent of patent claims that may be issued
to us in the future.
The standards which courts use to interpret patents may change,
particularly as new technologies develop. Consequently, we cannot be certain as
to how much protection, if any, will be given to patents owned or licensed by
us, if they are challenged in court. If we choose to go to court to stop someone
else from using the inventions claimed in these patents, that individual or
company has the right to ask the court to rule that the patents are invalid and
should not be enforced against them. Such lawsuits are expensive and will
consume time and other resources, even if we are successful in stopping the
violation of the patents. In addition, there is a risk that the court will
decide that some or all of the claims of these patents are not valid and that we
do not have the right to stop others from using the inventions. There is also a
risk that, even if the validity of the patents is upheld, the court will refuse
to stop the other party on the grounds that its activities are not covered by
the patent claims.
In addition, a third party may claim that we are using inventions
covered by their patents and may go to court to stop us from engaging in our
normal operations and activities, such as research and development and the
manufacture and sale of products. Such lawsuits are expensive and will consume
time and other resources. There is a risk that the court will decide that we are
violating the third party's patent and will order us to pay the other party
damages for having violated their patent. There is also a risk that the court
will order us to stop the activities covered by the patent. In this case, we may
attempt to obtain a license from the third party so that we may continue to use
the invention. However, we cannot assure you that if this occurs we would be
able to obtain the licenses we need or that we could negotiate the licenses on
terms acceptable to us, or at all.
Another risk we face in this area is that the laws of certain countries
may not protect our proprietary rights to the same extent as United States law.
We also rely in our business on trade secrets, know-how and other
proprietary information. We seek to protect this information, in part, through
the use of confidentiality agreements with employees, consultants, advisors and
others. Nonetheless, we cannot assure you that those agreements will provide
adequate protection for our trade secrets, know-how or other proprietary
information and prevent their unauthorized use or disclosure. There is also the
risk that our employees, consultants, advisors or others will not maintain the
confidentiality of such trade secrets or proprietary information, or that this
information may become known in some other way or be independently developed by
our competitors.
The occurrence of these risks could have a material adverse effect on
our business, financial condition and results of operations.
WE ARE SUBJECT TO EXTENSIVE GOVERNMENT REGULATION; OUR PRODUCTS MAY NOT RECEIVE
REGULATORY APPROVAL.
Human pharmaceutical products must undergo lengthy and rigorous
preclinical testing and clinical trials and other extensive, costly and
time-consuming procedures mandated by the FDA and foreign regulatory
authorities. To have a product candidate approved, we must establish that the
product candidate is safe and effective for each target indication. The FDA must
confirm that we and our clinical testing and manufacturing partners maintain
good laboratory, clinical and manufacturing practices. The regulatory approval
process typically takes a number of years, depending on the type, complexity and
novelty of the pharmaceutical product. Because of the considerable time and
expense required, this process gives larger companies with greater financial
resources a competitive advantage over us.
To date, none of our product candidates has been submitted for approval
by the FDA or any other regulatory authority for commercialization. Our products
may never be approved by the FDA or any other regulatory authority. T-20 and
T-1249 have received fast track designation from the FDA for the treatment of
HIV-infected individuals. Fast track designation is granted to products that may
provide a significant improvement in the safety or effectiveness of the
treatment for a serious or life-threatening disease, and this designation is
intended to expedite the review of these drugs. However, fast track designation
does not, in any way, mean that T-20 or T-1249 will be approved for
commercialization by the FDA in the future.
Our estimates of future regulatory submission dates may prove to be
inaccurate. Our regulatory submissions can be delayed or we may cancel plans to
submit proposed products for a number of reasons, including:
o unanticipated preclinical testing or clinical trial reports,
o changes in regulations, or the adoption of new regulations,
o unanticipated enforcement of existing regulations,
o unexpected technological developments, and
o developments by our competitors.
Consequently, we cannot assure you that our anticipated submissions
will be made on their target dates, or at all. Delays in these submissions would
have a material adverse effect on our business, financial condition and results
of operations.
A number of federal, state and local laws regulate safe working
conditions, laboratory and manufacturing practices, the experimental use of
animals and the use and disposal of hazardous or potentially hazardous
substances, including radioactive
10
<PAGE>
compounds and infectious disease agents. We must comply with these laws. We use
some of these hazardous substances in our product development programs. It is
expensive and time-consuming to comply with these laws. If we fail to comply,
our business, financial condition and results of operations could be materially
and adversely affected.
WE FACE INTENSE COMPETITION.
We are engaged in segments of the biopharmaceutical industry, including
the treatment of HIV, that are intensely competitive and change rapidly. We
expect that new developments in the areas in which we are conducting our
research and development will continue at a rapid pace in both industry and
academia.
If we successfully develop our product candidates and gain approval for
those products, they will compete with numerous existing therapies. For example,
at least 16 antiretroviral drugs are currently approved in the United States for
the treatment of HIV. We also believe that a significant number of drugs are
currently under development and will become available in the future for the
treatment of HIV. We expect to face intense and increasing competition in the
future as these new products enter the market and advanced technologies become
available. Even if we are able to successfully develop T-20 or T-1249 and either
product candidate receives regulatory approval, we cannot assure you that
existing or new products for the treatment of HIV developed by our competitors
will not be more effective, less expensive or more effectively marketed and
sold, than T-20, T-1249 or any other therapeutic for HIV that we may develop.
Many of our competitors have significantly greater financial,
technical, human and other resources than we do. Smaller companies may also
prove to be significant competitors, particularly through collaborative
arrangements with large pharmaceutical and biotechnology companies. Furthermore,
academic institutions, governmental agencies and other public and private
research organizations are becoming increasingly aware of the value of their
inventions and are more actively seeking to commercialize the technology they
have developed.
Several factors will help determine whether we will be able to compete
successfully in our market, including the following:
o the safety and effectiveness of our products,
o the speed with which we can gain regulatory approval for our
products and the scope of those approvals,
o our ability to manufacture, sell, market and distribute our
products, or to find someone else to handle these functions for us
in a timely and cost-efficient manner,
o the availability of reimbursement coverage for our products,
o our ability to offer our products at a competitive price, and
o the strength of our patents and the speed with which we can obtain
patents on our products and technologies.
We may not be able to effectively compete with our competitors in some
or all of these areas. This could have a material adverse effect on our
business, financial condition and results of operations.
WE USE HAZARDOUS MATERIALS.
We use hazardous materials, chemicals, viruses and various radioactive
compounds in our product development programs. We believe that our handling and
disposal of these materials comply with the standards prescribed by state and
federal regulations, but we cannot completely eliminate the risk of accidental
contamination or injury from these materials. If there were such an accident or
injury, we could be held liable for any damages or penalized with fines. The
amount of the liability and fines could exceed our resources. Additionally, if
we develop an internal manufacturing capability, we may incur substantial
additional costs to comply with environmental regulations.
WE ARE EXPOSED TO PRODUCT LIABILITY RISKS.
Our business exposes us to potential product liability risks that are
inherent in the testing, manufacturing and marketing of pharmaceutical products.
We cannot assure you that product liability claims will not be asserted against
us. In addition, the use in our clinical trials of pharmaceutical products that
our potential collaborators may develop and the subsequent sale of these
products by us or our potential collaborators may cause us to bear a portion of
product liability risks. A successful product liability claim or series of
claims brought against us could have a material adverse effect on our business,
financial condition and results of operations.
We do not currently have any product liability insurance relating to
clinical trials or any products or compounds we have or may develop. We cannot
assure you that we will be able to obtain or maintain adequate product liability
insurance on acceptable terms, if at all, or that such insurance will provide
adequate coverage against our potential liabilities. Furthermore, our
collaborators or licensees may not be willing to indemnify us against these
types of liabilities and may not themselves be sufficiently insured or have a
net worth sufficient to satisfy any product liability claims. Claims or losses
in excess of any product liability insurance coverage that may be obtained by us
could have a material adverse effect on our business, financial condition and
results of operations.
11
<PAGE>
WE DEPEND UPON CERTAIN KEY PERSONNEL AND FACE RISKS RELATING TO OUR ABILITY TO
ATTRACT AND RETAIN KEY PERSONNEL.
We depend on members of our senior management and scientific staff,
including Dr. Dani P. Bolognesi, our Chief Executive Officer and Chief
Scientific Officer. Dr. Bolognesi has limited experience acting as an executive
officer at a company such as ours, and has held this position at Trimeris only
since March 1999.
The future recruitment and retention of management personnel and
qualified scientific personnel is also critical to our success. We cannot be
certain that we will attract and retain qualified personnel on acceptable terms
given the competition among biotechnology, pharmaceutical and health care
companies, universities and non-profit research institutions for experienced
management personnel and scientists. In addition, we rely on scientific advisors
and other consultants to assist us in formulating our research and development
strategy. These consultants are employed by other parties and may have
commitments to, or advisory or consulting agreements with, other entities, which
may limit their availability to us.
FUTURE SALES OR COMMON STOCK BY OUR EXISTING STOCKHOLDERS COULD ADVERSELY AFFECT
OUR STOCK PRICE.
The market price of our common stock could decline as a result of sales
by our existing stockholders of shares of common stock in the market after this
offering, or the perception that these sales could occur. These sales also might
make it more difficult for us to sell equity securities in the future at a time
and at a price that we deem appropriate.
WE HAVE IMPLEMENTED CERTAIN ANTI-TAKEOVER PROVISIONS.
Certain provisions of our Certificate of Incorporation and Bylaws and
Delaware law could make it more difficult for a third party to acquire us, even
if the acquisition would be beneficial to our stockholders.
OUR ACTUAL RESULTS COULD DIFFER MATERIALLY FROM THOSE ANTICIPATED IN OUR
FORWARD-LOOKING STATEMENTS.
This prospectus contains forward-looking statements based on our
current expectations, assumptions, estimates and projections about our business
and industry. Our actual results could differ materially from those anticipated
in these forward-looking statements as a result of various factors, including
all the risks and uncertainties discussed above. We do not undertake to update
publicly any forward-looking statements for any reason, even if new information
becomes available or other events occur in the future.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of the shares by
the selling stockholders.
SELLING STOCKHOLDERS
We are registering the shares covered by this prospectus on behalf of
the selling stockholders named in the table below. We issued all of the shares
to the selling stockholders in a private placement transaction. We have
registered the shares to permit the selling stockholders and their pledgees,
donees, transferees or other successors-in-interest that receive their shares
from a selling stockholder as a gift, partnership distribution or other non-sale
related transfer after the date of this prospectus to resell the shares.
The following table sets forth the name of each selling stockholder,
the number of shares owned by each selling stockholder as of February 2, 2000,
the number of shares that may be offered under this prospectus and the number of
shares of our common stock owned by each selling stockholder after this offering
is completed. None of the selling stockholders has had a material relationship
with us within the past three years. The number of shares in the column "Number
of Shares Being Offered" represent all of the shares that each selling
stockholder may offer under this prospectus. The selling stockholders may sell
some, all or none of their shares. We do not know how long the selling
stockholders will hold the shares before selling them and we currently have no
agreements, arrangements or understandings with any of the selling stockholders
regarding the sale of any of the shares. The shares offered by this prospectus
may be offered from time to time by the selling stockholders.
The percentages of shares owned prior to the offering are based on
15,565,138 shares of our common stock outstanding, giving effect to the sale of
1,750,000 shares to the selling stockholders in the private placement.
12
<PAGE>
<TABLE>
<CAPTION>
Shares Beneficially Owned Shares Beneficially Owned
Prior to Offering After Offering
----------------- --------------
Number of Shares
Name Number Percent Being Offered Number Percent
---- ------ ------- ------------- ------ -------
<S> <C> <C> <C> <C> <C>
Alliance Quasar Fund 416,700 2.7% 50,000 366,700 2.4%
Baker Bros Investments, LLC 250,000 1.6% 250,000 0 0
Biotech Target S.A. 400,000 2.6% 400,000 0 0
College Retirement Equities Fund for
its Global Equities Account 63,000 * 63,000 0 0
Delaware Group Equity Funds, III, on
behalf of its Delaware Trend Fund 55,000 * 55,000 0 0
Delaware Group Premium Fund, on behalf
of its Trend Series 28,800 * 28,800 0 0
Delaware Management Company,
investment adviser on behalf of PACE
Small/Medium Company Growth Equity
Investments 15,800 * 15,800 0 0
Delaware Pooled Trust, on behalf of
its The Small-Cap Growth Equity
Portfolio 400 * 400 0 0
Four Partners 2,012,500 12.9% 250,000 1,762,500 11.3%
INVESCO Global Health Sciences 115,000 * 115,000 0 0
Janus Global Life Sciences Fund 400,000 2.6% 400,000 0 0
Lawrence & Company 60,000 * 60,000 0 0
Shaker Investments for RCB Trust Co
Emerging Advisors Fund Grantor Trust
Program 6,960 * 6,960 0 0
Shaker Investments for RCB Trust Co
Emerging Advisors - Employee Benefits
Trust 18,000 * 18,000 0 0
Shaker Investments for Bell South 7,000 * 7,000 0 0
Shaker Investments for Cordant
Technologies Inc. Pension and Savings
Plan 880 * 880 0 0
Shaker Investments for RCB Trust
-Oregon Investment Council 7,160 * 7,160 0 0
TIAA-CREF Mutual Funds for its Growth
and Income Fund 7,000 * 7,000 0 0
Turner Micro Cap Fund 15,000 * 15,000 0 0
-----
* Less than 1%.
</TABLE>
13
<PAGE>
PLAN OF DISTRIBUTION
The selling stockholders may sell the shares from time to time. We will
not receive any proceeds from the sale of the shares by the selling
stockholders. The selling stockholders will act independently of us in making
decisions regarding the timing, manner and size of each sale. The sales may be
made on one or more exchanges or in the over-the-counter market or otherwise, at
prices and at terms then prevailing or at prices related to the then current
market price, or in privately negotiated transactions. The selling stockholders
may effect these transactions by selling the shares to or through
broker-dealers. The selling stockholders may sell their shares in one or more
of, or a combination of:
- a block trade in which the broker-dealer will attempt to sell the
shares as agent but may position and resell a portion of the block
as principal to facilitate the transaction,
- purchases by a broker-dealer as principal and resale by a
broker-dealer for its account under this prospectus,
- an exchange distribution in accordance with the rules of an
exchange,
- ordinary brokerage transactions and transactions in which the
broker solicits purchasers, and
- privately negotiated transactions.
To the extent required, this prospectus may be amended or supplemented
from time to time to describe a specific plan of distribution. If the plan of
distribution involves an arrangement with a broker-dealer for the sale of shares
through a block trade, special offering, exchange distribution or secondary
distribution or a purchase by a broker or dealer, the amendment or supplement
will disclose:
- the name of each selling stockholder and of the participating
broker-dealer(s),
- the number of shares involved,
- the commissions paid or discounts or concessions allowed to the
broker-dealer(s), where applicable,
- that a broker-dealer(s) did not conduct any investigation to
verify the information set out or incorporated by reference in
this prospectus, and
- other facts material to the transaction.
From time to time, a selling stockholder may transfer, pledge, donate
or assign its shares of common stock to lenders or others and each of such
persons will be deemed to be a "selling stockholder" for purposes of this
prospectus. The number of shares of common stock beneficially owned by the
selling stockholder will decrease as and when it takes such actions. The plan of
distribution for the selling stockholders' shares of common stock sold under
this prospectus will otherwise remain unchanged, except that the transferees,
pledgees, donees or other successors will be selling stockholders hereunder.
Upon being notified by a selling stockholder that a donee or pledgee intends to
sell more than 500 shares, we will file a supplement to this prospectus.
The selling stockholders may enter into hedging transactions with
broker-dealers in connection with distributions of the shares or otherwise. In
these transactions, broker-dealers may engage in short sales of the shares in
the course of hedging the positions they assume with selling stockholders. The
selling stockholders also may sell shares short and redeliver the shares to
close out short positions. The selling stockholders may enter into option or
other transactions with broker-dealers which require the delivery to the
broker-dealer of the shares. The broker-dealer may then resell or otherwise
transfer the shares under this prospectus. The selling stockholders also may
loan or pledge the shares to a broker-dealer. The broker-dealer may sell the
loaned shares, or upon a default the broker-dealer may sell the pledged shares
under this prospectus.
In effecting sales, broker-dealers engaged by the selling stockholders
may arrange for other broker-dealers to participate in the resales.
Broker-dealers or agents may receive compensation in the form of commissions,
discounts or concessions from selling stockholders. Broker-dealers or agents may
also receive compensation from the purchasers of the shares for whom they act as
agents or to whom they sell as principals, or both. Compensation as to a
particular broker-dealer might be in excess of customary commissions and will be
in amounts to be negotiated in connection with the sale. Broker-dealers or
agents and any other participating broker-dealers or the selling stockholders
may be deemed to be "underwriters" within the meaning of Section 2(11) of the
Securities Act of 1933, as amended, in connection with sales of the shares.
Accordingly, any commission, discount or concession received by them and any
profit on the resale of the shares purchased by them may be deemed to be
underwriting discounts or commissions under the Securities Act. Because selling
stockholders may be deemed to be "underwriters" within the meaning of Section
2(11) of the Securities Act, the selling stockholders will be subject to the
prospectus delivery requirements of the Securities Act. In addition, any
securities covered by this prospectus that qualify for sale under Rule 144
promulgated under the Securities Act may be sold under Rule 144 rather than
under this prospectus. The selling stockholders have advised that they have not
entered into any agreements, understandings or arrangements with any
underwriters or broker-dealers regarding the sale of their securities. There is
no underwriter or coordinating broker acting in connection with the proposed
sale of shares by the selling stockholders.
The shares will be sold only through registered or licensed brokers or
dealers if required under applicable state securities laws. In addition, in some
states the shares may not be sold unless they have been registered or qualified
for sale in the applicable state or an exemption from the registration or
qualification requirement is available and is compiled with.
14
<PAGE>
Under applicable rules and regulations under the Securities Exchange
Act of 1934, as amended, any person engaged in the distribution of the shares
may not simultaneously engage in market making activities with respect to our
common stock for a period of two business days prior to the commencement of the
distribution. In addition, each selling stockholder will be subject to
applicable provisions of the Exchange Act and the associated rules and
regulations under the Exchange Act, including Regulation M, which provisions may
limit the timing of purchases and sales of shares of our common stock by the
selling stockholders. We will make copies of this prospectus available to the
selling stockholders and have informed them of the need to deliver copies of
this prospectus to purchasers at or prior to the time of any sale of the shares.
We will bear all costs, expenses and fees in connection with the
registration of the shares. The selling stockholders will bear all commissions
and discounts, if any, attributable to the sales of the shares. The selling
stockholders may agree to indemnify any broker-dealer or agent that participates
in transactions involving sales of the shares against specific liabilities,
including liabilities arising under the Securities Act. The selling stockholders
have agreed to indemnify specific persons, including broker-dealers and agents,
against specific liabilities in connection with the offering of the shares,
including liabilities arising under the Securities Act.
We have agreed to maintain the effectiveness of this registration
statement until each selling stockholder can sell all of the shares it holds
under Rule 144(k) promulgated under the Securities Act. The selling stockholders
may sell all, some or none of the shares offered by this prospectus.
LEGAL MATTERS
The validity of the shares of common stock offered will be passed upon
for us by Wilmer, Cutler & Pickering, Washington D.C. A partner of Wilmer,
Cutler & Pickering beneficially owns 9,804 shares of our common stock. Our
Acting Chief Financial Officer and Acting Chief Administrative Officer, who
beneficially owns 19,316 shares of our common stock and has options to purchase
an aggregate of 118,529 shares of common stock, serves as a consultant to
Wilmer, Cutler & Pickering on matters unrelated to us.
EXPERTS
The financial statements of Trimeris, Inc. as of December 31, 1997 and
1998 and for each of the years in the three-year period ended December 31, 1998
and for the cumulative period from the date of inception to December 31, 1998
incorporated in this prospectus by reference to the annual report on Form 10-K
of Trimeris, Inc. for the year ended December 31, 1998, have been incorporated
by reference in reliance upon the report of KPMG LLP, independent certified
public accountants, incorporated by reference herein, and upon the authority of
KPMG LLP as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We have filed a registration statement on Form S-3 with the SEC in
connection with this offering. In addition, we file annual, quarterly and
current reports, proxy statements and other information with the SEC. You may
read and copy the registration statement and any other documents filed by us at
the SEC's Public Reference Room at 450 Fifth Street, N. W., Washington, D.C.
20549. Please call the SEC at 1-800-SEC-0330 for further information on the
Public Reference Room. Our SEC filings are also available to the public at the
SEC's Internet site at http://www.sec.gov.
This prospectus is part of the registration statement and does not
contain all of the information included in the registration statement. Whenever
a reference is made in this prospectus to any contract or other document of the
Trimeris, the reference may not be complete and you should refer to the exhibits
that are a part of the registration statement for a copy of the contract or
document.
INFORMATION INCORPORATED BY REFERENCE
The following documents filed by us with the SEC are hereby
incorporated by reference in this prospectus:
o the Annual Report of Trimeris, Inc. on Form 10-K for the fiscal
year ended December 31, 1998,
o the Quarterly Reports of Trimeris, Inc. on Form 10-Q for the
fiscal quarters ended March 31, 1999, June 30, 1999 and September
30, 1999,
o the Current Reports of Trimeris, Inc. on Form 8-K filed February
4, 2000, January 28, 2000, September 10, 1999, July 16, 1999, May
17, 1999, March 26, 1999 and March 16, 1999, and
o the description of the common stock contained in its Registration
Statement on Form 8-A filed on October 1, 1997.
All reports and other documents subsequently filed by us pursuant to
Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this
prospectus and prior to the termination of the offering shall be deemed to be
incorporated by reference in this prospectus and to be a part of this prospectus
from the date of filing of such reports and documents. Any statement contained
in any document incorporated or deemed to be incorporated by reference herein
shall be deemed to be modified or superseded for purposes of this prospectus to
the extent that a statement contained in this prospectus or in any other
subsequently filed document which also is or is deemed to be incorporated by
reference in this prospectus modifies or supersedes such statement. Any
statement so modified or superseded shall not be deemed, except as so modified
or superseded, to constitute a part of this prospectus.
15
<PAGE>
We will provide without charge to each person to whom this prospectus
is delivered, upon written or oral request a copy of any or all of the foregoing
documents incorporated by reference in this prospectus, except for exhibits to
these documents, unless the exhibits are specifically incorporated by reference
into any such document. You should direct your requests for such documents to
Investor Relations at Trimeris, Inc., 4727 University Drive, Suite 100, Durham,
North Carolina 27707 or by telephone at (919) 419-6050.
16
<PAGE>
We have not authorized any dealer, salesperson or other person to give
any information or represent anything not contained in this prospectus. You must
not rely on any unauthorized information. If anyone provides you with different
or inconsistent information, you should not rely on it. This prospectus does not
offer to sell any shares in any jurisdiction where it is unlawful. The
information in this prospectus is current as of the date shown on the cover
page.
1,750,000 SHARES
[TRIMERIS LOGO]
Trimeris, Inc.
COMMON STOCK
P R O S P E C T U S
________ __, 2000
17
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The following table sets forth an estimate of the fees and expenses
relating to the issuance and distribution of the securities being registered
hereby, other than underwriting discounts and commissions, all of which shall be
borne by Trimeris, Inc. (the "Registrant" or the "Company"). All of such fees
and expenses, except for the SEC Registration Fee, are estimated:
<TABLE>
<CAPTION>
<S> <C>
SEC Registration Fee...................................................... $ 27,027
Transfer agent's fees and expenses........................................ $ 5,000
Legal fees and expenses................................................... $ 150,000
Printing fees and expenses................................................ $ 10,000
Accounting fees and expenses.............................................. $ 20,000
Miscellaneous expenses.................................................... $ 12,973
Total............................................................ $ 225,000
</TABLE>
Item 15. Indemnification of Directors and Officers
Under Section 145 of the Delaware General Corporation Law (the "DGCL"),
a corporation may indemnify its directors, officers, employees and agents and
its former directors, officers, employees and agents and those who serve, at the
corporation's request, in such capacities with another enterprise, against
expenses (including attorneys' fees), as well as judgments, fines and
settlements in non-derivative lawsuits, actually and reasonably incurred in
connection with the defense of any action, suit or proceeding in which they or
any of them were or are made parties or are threatened to be made parties by
reason of their serving or having served in such capacity. The DGCL provides,
however, that such person must have acted in good faith and in a manner he or
she reasonably believed to be in (or not opposed to) the best interests of the
corporation and, in the case of a criminal action, such person must have had no
reasonable cause to believe his or her conduct was unlawful. In addition, the
DGCL does not permit indemnification in an action or suit by or in the right of
the corporation, where such person has been adjudged liable to the corporation,
unless, and only to the extent that, a court determines that such person fairly
and reasonably is entitled to indemnity for costs the court deems proper in
light of liability adjudication. Indemnity is mandatory to the extent a claim,
issue or matter has been successfully defended. Section 145 of the DGCL also
provides that a corporation has the power to purchase and maintain insurance on
behalf of its officers and directors against any liability asserted against such
person and incurred by him or her in such capacity, or arising out of his or her
status as such, whether or not the corporation would have the power to indemnify
him or her against such liability under the provisions of Section 145 of the
DGCL.
The Company's Third Amended and Restated Certificate of Incorporation
contains certain provisions permitted under the DGCL relating to the liability
of directors. These provisions eliminate a director's personal liability for
monetary damages resulting from a breach of fiduciary duty, except in certain
circumstances involving certain wrongful acts, such as (i) for any breach of the
director's duty of loyalty to the Company or its stockholders; (ii) for acts or
omissions not in good faith or which involve intentional misconduct or a knowing
violation of law, (iii) under Section 174 of the Delaware law, (iv) for any
transaction for which the director derives an improper personal benefit or (v)
acts or omissions occurring prior to the date of these provisions. These
provisions do not limit or eliminate the rights of the Company or any
stockholder to seek equitable relief, such as an injunction or recession, in the
event of a breach of a director's fiduciary duty. These provisions will not
alter a director's liability under federal securities laws. The Company's Third
Amended and Restated Certificate of Incorporation also contain provisions
indemnifying the directors and officers of the Company to the fullest extent
permitted by DGCL.
The Company's bylaws provide that the Company shall indemnify its
directors and executive officers to the fullest extent permitted by the DGCL.
The rights to indemnity thereunder continue as to a person who has ceased to be
a director, officer, employee or agent and inure to the benefit of the heirs,
executors and administrators of the person. In addition, expenses incurred by a
director or officer in defending any civil, criminal, administrative or
investigative action, suit or proceeding by reason of the fact that he or she is
or was a director or officer of the Company (or was serving at the Company's
request as a director or officer of another corporation) shall be paid by
II-1
<PAGE>
the Company in advance of the final disposition of such action, suit or
proceeding upon receipt of an undertaking by or on behalf of such director or
officer to repay such amount if it shall ultimately be determined that he or she
is not entitled to be indemnified by the Company as authorized by the relevant
section of the DGCL.
The Company has entered into indemnification agreements with each of
its directors and executive officers. Generally, these indemnification
agreements provide the maximum protection available under DGCL, as it may be
amended from time to time. Under these indemnification agreements, however,
individuals do not receive indemnification for judgments, settlements or
expenses if he or she is found liable to the Company (except to the extent the
court determines he or she is fairly and reasonably entitled to indemnity for
expenses), for settlements not approved by the Company or for settlements and
expenses if the settlement is not approved by the court. The indemnification
agreements provide for the Company to advance to the individual any and all
reasonable expenses (including legal fees and expenses) incurred in
investigating or defending any such action, suit or proceeding. In order to
receive an advance of expenses, the individual must submit to the Company copies
of invoices presented to him or her for such expenses. Also, the individual must
repay such advances upon a final judicial decision that he or she is not
entitled to indemnification.
Item 16. Exhibits
The exhibits to this registration statement are listed in the Exhibit
Index to this registration statement, which Exhibit Index is hereby incorporated
by reference.
Item 17. Undertakings
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made,
a post-effective amendment to this registration statement: (i) to include any
prospectus required by Section 10(a)(3) of the Securities Act of 1933; (ii) to
reflect in the prospectus any facts or events arising after the effective date
of 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. Not withstanding 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 end 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 clauses (i) and (ii) do not apply if the
information required to be included in a post-effective amendment by those
clauses is contained in periodic reports filed with or furnished to the
Commission by the registrant pursuant to Section 13 or Section 15(d) of the
Securities Exchange Act of 1934 that are incorporated by reference in the
registration statement.
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be deemed to be
a new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial BONA
FIDE offering thereof.
(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.
The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
Registrant's annual report pursuant to Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to Section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in 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.
Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to directors, officers and controlling persons of
the Registrant, the Registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy
as expressed in the Act and is, therefore, unenforceable. In the event that a
claim for indemnification against such liabilities (other than the
II-2
<PAGE>
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 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 ground 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 Durham, County of Durham, State of North Carolina on
this 3rd day of March, 2000.
TRIMERIS, INC.
By: /s/ Dani P. Bolognesi
----------------------------
Dani P. Bolognesi, Ph.D.
Chief Executive Officer and
Chief Scientific Officer
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below
under the heading "Signature" constitutes and appoints Dani P. Bolognesi and
Timothy J. Creech as his true and lawful attorneys-in-fact each acting alone,
with full power of substitution and resubstitution, for him and in his name,
place and stead in any and all capacities to sign any or all amendments
(including post-effective amendments) to this registration statement and to file
the same, with all exhibits thereto, and other documents in connection
therewith, with the Securities and Exchange Commission, granting unto said
attorneys-in-fact full power and authority to do and perform each and every act
and thing requisite and necessary to be done in and about the premises, as fully
for all intents and purposes as he might or could do in person, hereby ratifying
and confirming all that said attorneys-in-fact, or their substitutes, each
acting alone, may lawfully do or cause to be done by virtue hereof.
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/Dani P. Bolognesi Chief Executive Officer (principal executive March 3, 2000
------------------------ officer), Chief Scientific Officer and Director
Dani P. Bolognesi, Ph.D.
/s/Robert R. Bonczek Acting Chief Administrative and Chief Financial March 3, 2000
------------------------ Officer (principal financial officer)
Robert R. Bonczek
/s/Timothy J. Creech Director of Finance and Administration and March 3, 2000
------------------------ Secretary (principal accounting officer)
Timothy J. Creech
/s/Jeffrey M. Lipton Chairman of the Board of Directors March 3, 2000
------------------------
Jeffrey M. Lipton
/s/Jesse I. Treu Director March 3, 2000
------------------------
Jesse I. Treu, Ph.D.
/s/E. Gary Cook Director March 3, 2000
------------------------
E. Gary Cook, Ph.D.
/s/Charles A. Sanders Director March 3, 2000
------------------------
Charles A. Sanders, M.D.
/s/J. Richard Crout Director March 3, 2000
------------------------
J. Richard Crout, M.D.
</TABLE>
II-4
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibit Number Description
- -------------- -----------
<S> <C>
4.1* Specimen certificate for shares of Common Stock
4.2* Description of Capital Stock
10** Form of Purchase Agreement dated as of January 28, 2000 by and among Trimeris, Inc.
and the purchasers set forth on the signature pages thereto.
5 Opinion of Wilmer, Cutler & Pickering as to the legality of the securities being
registered
23.1 Consent of Wilmer, Cutler & Pickering (included in Exhibit 5)
23.2 Consent of KPMG LLP
24 Power of attorney (included on signature pages of this registration statement)
* Incorporated by reference to Trimeris' Registration Statement on Form S-1 (File No. 333-31109).
** Incorporated by reference to Trimeris' Current Report on Form 8-K dated February 4, 2000.
</TABLE>
All financial statement schedules have been omitted because either they
are not required, are not applicable, or the information is otherwise set forth
in the Financial Statements and Notes thereto.
II-5
Exhibit 5
WILMER, CUTLER & PICKERING
2445 M STREET, N.W.
WASHINGTON, D.C. 20037-1420
Telephone (202) 663-6000
Facsimile (202) 663-6363
March 3, 2000
Trimeris, Inc.
4727 University Drive
Durham, NC 27707
Re: Trimeris, Inc. Registration Statement on Form S-3
Ladies and Gentlemen:
This opinion is furnished to you in connection with a registration
statement on Form S-3 (the "Registration Statement"), filed today with the
Securities and Exchange Commission under the Securities Act of 1933, as amended,
for the registration of 1,750,000 shares of Common Stock, $.001 par value (the
"Shares"), of Trimeris, Inc., a Delaware corporation (the "Company"). The
Company originally sold the Shares pursuant to Purchase Agreements dated as of
January 28, 2000 by and among the Company and the investors listed on the
signature pages therein. The Shares are being registered to permit the resale of
such Shares by the holders thereof from time to time after the effective date of
the Registration Statement.
We have acted as counsel for the Company in connection with its
issuance and sale of the Shares and the preparation of the Registration
Statement. For purposes of this opinion, we have examined and relied upon such
documents, records, certificates and other instruments as we have deemed
necessary.
This opinion is limited to the laws of the United States and the
general corporate law of Delaware. Although we do not hold ourselves out as
being experts in the laws of Delaware, we have made an investigation of such
laws to the extent necessary to render our opinion. Our opinion is rendered only
with respect to the laws and the rules, regulations and orders thereunder that
are currently in effect.
Based on the foregoing, we are of the opinion that the Shares have been
duly authorized and validly issued, and are fully paid and non-assessable.
<PAGE>
Trimeris, Inc.
March 3, 2000
Page 2
We hereby consent to your filing this opinion as an exhibit to the
Registration Statement and to the use of our name therein and in the related
prospectus under the caption "Legal Matters."
It is understood that this opinion is to be used only in connection
with the offer and sale of the Shares while the Registration Statement is in
effect.
Sincerely,
Wilmer, Cutler & Pickering
By: /s/ John B. Watkins
-------------------------
John B. Watkins, a partner
EXHIBIT 23.2
[LOGO] KPMG
150 Fayetteville Street Mall
Suite 1200
Post Office Box 29543
Raleigh, NC 27628-0543
The Board of Directors
Trimeris, Inc.
We consent to the use of our report incorporated herein by reference and to the
reference to our firm under the heading "Experts" in the prospectus.
/s/ KPMG LLP
Raleigh, North Carolina
March 3, 2000
