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As filed with the Securities and Exchange Commission on November 21, 1995
Registration No. 33-64021
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_________________
AMENDMENT NO. 1 TO
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
_________________
T CELL SCIENCES, INC.
(Exact name of Registrant as specified in its charter)
DELAWARE 13-3191702
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification Number)
115 FOURTH AVENUE, NEEDHAM, MASSACHUSETTS 02194 (617) 433-0771
(Address, including zip code, and telephone number, including
area code, of Registrant's principal executive offices)
_________________
ALAN W. TUCK, PRESIDENT AND CHIEF EXECUTIVE OFFICER
T CELL SCIENCES, INC.
115 FOURTH AVENUE
NEEDHAM, MASSACHUSETTS 02194 (617) 433-0771
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
_________________
Copies of all communications should be sent to:
STUART M. CABLE, ESQ.
GOODWIN, PROCTER & HOAR
EXCHANGE PLACE, 24TH FLOOR
BOSTON MASSACHUSETTS 02109-2881
(617) 570-1000
Approximate date of commencement of proposed sale to the public: From
time to time after the effective date of this Registration Statement.
If any of the securities being registered on this Form are to be offered
on a delayed or continuous basis pursuant to Rule 415 under the Securities Act
of 1933, check the following box. [X]
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CALCULATION OF REGISTRATION FEE
============================================================================================================
TITLE OF EACH CLASS OF PROPOSED MAXIMUM PROPOSED MAXIMUM
SECURITIES TO BE AMOUNT TO BE OFFERING PRICE PER AGGREGATE OFFERING AMOUNT OF
REGISTERED REGISTERED SHARE (1) PRICE (1) REGISTRATION FEE (2)
- ------------------------------------------------------------------------------------------------------------
Common Stock, par 2,761,816 $3.00 $8,285,448 $2,857
value $.001 per share
============================================================================================================
(1) Estimated solely for the purpose of calculating the registration fee.
(2) Pursuant to Rule 457(c) under the Securities Act of 1933, the
registration fee has been calculated based upon the average of the high
and low prices per share of Common Stock on the Nasdaq National Market
System on November 3, 1995.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON 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 1993 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A),
SHALL DETERMINE.
================================================================================
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SUBJECT TO COMPLETION, DATED NOVEMBER 21, 1995
INFORMATION CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT. A
REGISTRATION STATEMENT RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION. THESE SECURITIES MAY NOT BE SOLD NOR MAY
OFFERS TO BUY BE ACCEPTED PRIOR TO THE TIME THE REGISTRATION STATEMENT BECOMES
EFFECTIVE. THIS PROSPECTUS SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE
SOLICITATION OF AN OFFER TO BUT NOR SHALL THERE BE ANY SALE OF THESE SECURITIES
IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL
PRIOR TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH
STATE.
PROSPECTUS
T CELL SCIENCES
2,761,816 Shares Common Stock
This Prospectus relates to 2,761,816 shares ("Shares") of common
stock, $.001 par value per share of T Cell Sciences, Inc. (the "Common Stock")
to be sold by certain stockholders of the Company (the "Selling Stockholders")
from time to time. The Selling Stockholders may sell the Shares from time to
time in transactions on the Nasdaq National Market System, in negotiated
transactions, or by a combination of these methods, at fixed prices that may be
changed, at market prices at the time of sale, at prices related to market
prices or at negotiated prices. The Selling Stockholders may effect these
transactions by selling the Shares to or through broker-dealers, who may
receive compensation in the form of discounts or commissions from the Selling
Stockholders or from the purchasers of the Shares for whom the broker- dealers
may act as an agent or to whom they may sell as a principal, or both. See
"Selling Stockholders" and "Plan of Distribution." The Common Stock of the
Company is traded under the symbol "TCEL" on the National Association of
Securities Dealers Automated Quotation System ("Nasdaq"), National Market
System. On November 3, 1995, the reported closing price for the Common Stock
on the Nasdaq National Market System was $3.125.
The Company will not receive any of the proceeds from the sale of the
Shares. The Company has agreed to bear all of the expenses in connection with
the registration and sale of the Shares (other than underwriting discounts and
selling commissions and the fees and expenses of counsel or other advisors to
the Selling Stockholders).
____________________
SEE "RISK FACTORS" FOR A DISCUSSION OF CERTAIN SPECIAL FACTORS WHICH
SHOULD BE CONSIDERED BY PROSPECTIVE PURCHASERS OF THE SHARES OFFERED HEREBY.
____________________
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS
THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION
PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO
THE CONTRARY IS A CRIMINAL OFFENSE.
____________________
NO PERSON HAS BEEN AUTHORIZED IN CONNECTION WITH THE SALE OF ANY
SHARES PURSUANT TO THIS PROSPECTUS TO GIVE ANY INFORMATION OR TO MAKE ANY
REPRESENTATION OTHER THAN AS CONTAINED IN THIS PROSPECTUS, AND IF GIVEN OR
MADE, ANY SUCH INFORMATION OR REPRESENTATION MAY NOT BE RELIED ON AS HAVING
BEEN AUTHORIZED BY THE COMPANY.
____________________
NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE PURSUANT TO
THIS PROSPECTUS SHALL UNDER ANY CIRCUMSTANCES CREATE ANY IMPLICATION THAT THERE
HAS BEEN NO CHANGE IN THE COMPANY'S AFFAIRS SINCE THE DATE OF THIS PROSPECTUS.
____________________
THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION
OF AN OFFER TO BUY ANY SECURITY OTHER THAN THE SECURITIES COVERED BY THIS
PROSPECTUS, NOR DOES IT CONSTITUTE AN OFFER TO OR SOLICITATION OF ANY PERSON IN
ANY JURISDICTION IN WHICH AN OFFER OR SOLICITATION MAY NOT BE LAWFULLY MADE.
THE DATE OF THIS PROSPECTUS IS NOVEMBER __, 1995.
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AVAILABLE INFORMATION
The Company is subject to the informational requirements of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), and, in
accordance therewith, files proxy statements, reports and other information
with the Securities and Exchange Commission (the "Commission"). Such proxy
statements, reports and other information filed by the Company may be inspected
and copied at the public reference facilities maintained by the Commission at
Room 1024, Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C. 20549 or
at the Regional Offices of the Commission at Room 3190, John C. Kluczynski
Building, 230 South Dearborn Street, Chicago, Illinois 60604, and Room 1400, 75
Park Place, New York, New York 10007. Copies of such material can be obtained
at prescribed rates from the Public Reference Section of the Commission at Room
1024, Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C. 20549. The
Common Stock of the Company is traded on the Nasdaq National Market System.
Reports and other information concerning the Company may be inspected at the
National Association of Securities Dealers, Inc., 1735 K Street, N.W.,
Washington, D.C. 20006.
The Company has filed with the Commission a Registration Statement on
Form S-3 under the Securities Act of 1933, as amended (the "Securities Act"),
with respect to the securities offered hereby. This Prospectus does not contain
all the information set forth in the Registration Statement, certain parts of
which are omitted in accordance with the rules and regulations of the
Commission. For further information with respect to the Company and the
securities covered hereby, reference is made to the Registration Statement and
to the exhibits thereto filed as a part thereof.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The Company will furnish without charge to each person, including any
beneficial owner, to whom this Prospectus is delivered, upon request, a copy of
any or all of the documents that have been incorporated by reference to the
Registration Statement of which this Prospectus is a part, other than exhibits
to such documents. Requests should be addressed to: T Cell Sciences, Inc., 115
Fourth Avenue, Needham, Massachusetts 02194, Attention: Investor Relations
(telephone number (617) 433-0771).
The following documents filed by the Company with the Commission are
incorporated in, and made a part of, this Prospectus by reference as of their
respective dates: (1) the Company's Annual Report to Stockholders on Form 10-K
for the fiscal year ended December 31, 1994; (2) the Company's Quarterly
Reports on Form 10-Q for the fiscal quarters ended March 31, 1995, June 30,
1995 and September 30, 1995; (3) the Company's Current Reports on Form 8-K,
filed on May 18, 1995 and April 7, 1995; and (4) the definitive Proxy Statement
of the Company for the Annual Meeting of Stockholders held May 18, 1995.
Each document filed subsequent to the date of this Prospectus pursuant
to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the
termination of this offering shall be deemed to be incorporated by reference in
this Prospectus and shall be a part hereof from the date of filing of such
document.
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RISK FACTORS
In addition to the other information in this Prospectus, the following
factors should be considered carefully in evaluating an investment in the
shares of Common Stock offered by this Prospectus.
Early Stage of Product Development. All of the Company's therapeutic
products are in various stages of research and development, and no revenues
have been generated from the commercialization of those products. The Company
currently sells products to the laboratory reagent and medical diagnostic
markets. The Company's therapeutic and new diagnostic products will require
substantial additional development, including in the areas of preclinical and
clinical testing, regulatory approvals and manufacturing processes prior to
their commercialization. There can be no assurance that any of the Company's
therapeutic and diagnostic products which are under development will prove to
be safe or effective in clinical trials, will be approved by regulatory
authorities, can be manufactured at acceptable cost with appropriate quality,
or can be successfully marketed.
History of Losses; Uncertainty of Future Profitability. The Company
has incurred operating losses since its inception and had accumulated net
losses of approximately $43.1 million as of June 30, 1995. The continued
development of the Company's products will require the commitment of
substantial resources to conduct research and preclinical and clinical
programs, to establish manufacturing capabilities and sales and marketing
capabilities, and to establish additional quality control, regulatory and
administrative capabilities. The Company may incur substantial and increasing
operating losses over the next several years as its product development
programs and clinical testing expand. The amount of net losses and the time
required by the Company to reach sustained profitability are highly uncertain
and to achieve profitability the Company must, among other things, successfully
complete development of its products, obtain regulatory approvals and establish
manufacturing and marketing capabilities. There can be no assurance that the
Company will be able to achieve profitability at all or on a sustained basis.
Need for Additional Funds. The Company has funded its operations and
capital expenditures to date primarily through equity financing, strategic
alliances with commercial partners, and sales of reagent and diagnostic
products. Since inception, the Company has raised proceeds, net of expenses, of
approximately $57 million through equity financings. The Company anticipates
that it will need to raise substantial additional funds, through additional
equity or debt financings, research and development financings, collaborative
relationships or otherwise, prior to the commercialization of its products.
There can be no assurance that any such additional funding will be available to
the Company or, if available, that it will be on reasonable terms. Any such
additional funding may result in significant dilution to existing stockholders.
If adequate funds are not available, the Company may be required to
significantly curtail its research and development programs or obtain funds
through arrangements with collaborative partners that may require the Company
to relinquish certain material rights to its products.
Dependence on Third Parties for Clinical Supplies. The Company is
dependent on its former commercial partner, SmithKline Beecham p.l.c., to
produce quantities of its first therapeutic product candidate, sCR1, suitable
for Phase II clinical trials, and is dependent on sourcing from a third party
manufacturer for additional suitable quantities of sCR1 for additional clinical
trials. There can be no assurance at this time that the Company will be able
to utilize any of the material produced by its former partner or new
manufacturing source in the clinical trials. The inability to have suitable
quality and quantities of material produced would result in significant delays
in the clinical development of sCR1.
No Assurance of FDA Approval; Comprehensive Government Regulation.
The Company's research, development and clinical programs, as well as its
manufacturing and marketing operations, are subject to extensive regulation by
numerous governmental authorities in the United States and other countries.
Most of the Company's products require governmental approvals for
commercialization which have not yet been obtained and are not expected to be
obtained for several years. Preclinical and clinical trials and manufacturing
and marketing of many of the Company's products will be subject to the rigorous
testing and approval processes of the FDA and corresponding foreign regulatory
authorities. The regulatory process, which includes preclinical, clinical and
post-clinical testing of many of the Company's products to establish their
safety and efficacy, can take many years and requires the expenditure of
substantial resources. Data obtained from preclinical and clinical activities
are susceptible to varying interpretations which could delay, limit or prevent
regulatory approval. In addition, delays or rejection may be
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encountered based upon changes in, or additions to, regulatory policies for
drug approval during the period of product development and regulatory review.
Delays in obtaining such approvals could adversely affect the marketing of
products developed by the Company and the Company's ability to generate
commercial product revenues. There can be no assurance that requisite
regulatory approvals will be obtained within a reasonable period of time, if at
all. Moreover, if regulatory approval of a product is granted, such approval
may impose limitations on the indicated uses for which such product may be
marketed. Further, even if such regulatory approval is obtained, a marketed
product, its manufacturer and its manufacturing facilities are subject to
continual review and periodic inspections, and later discovery of previously
unknown problems with a product, manufacturer or facility may result in
restrictions on such product or manufacturer, including withdrawal of the
product from the market. Failure to comply with the applicable regulatory
requirements can, among other things, result in fines, suspensions of
regulatory approvals, product recalls, operating restrictions and criminal
prosecution.
Lack of Commercial Manufacturing Capability. To be successful, the
Company's diagnostic and therapeutic products must be manufactured in
commercial quantities, within regulatory requirements and at competitive costs.
The Company's experience in commercial manufacturing is limited to the
manufacturing of certain reagents and medical diagnostic test kits and there
can be no assurance that the Company will be able to successfully continue to
scale-up its diagnostic manufacturing operations to meet future market demands
or to obtain access to suitable therapeutic manufacturing facilities.
Lack of Commercial Sales and Marketing Experience. Except for
research reagents and certain diagnostic products, the Company has limited
experience in sales, marketing and distribution of commercial products. To
market any of its products directly, the Company must develop a substantial
marketing and sales force with technical expertise and a supporting
distribution capability. Alternatively, the Company may seek to obtain the
assistance of a strategic partner with the necessary sales and distribution
capabilities and expertise. There can be no assurance that the Company will be
able to establish sales and distribution capabilities without undue delays or
expenditures or that it will be successful in gaining market acceptance for its
products.
Competition and Risk of Technological Obsolescence. Biotechnology,
pharmaceuticals and medical diagnostics are rapidly evolving fields in which
developments are expected to continue at a rapid pace. Competitors of the
Company in the United States and abroad are numerous and include, among others,
pharmaceuticals, medical diagnostics, biotechnology companies, universities and
other research institutions. The Company's success depends upon developing and
maintaining a competitive position in the development of products and
technologies in its area of focus. Competition from other biotechnology,
pharmaceuticals and medical diagnostics companies is intense and expected to
increase as new products enter the market and new technologies become
available. The Company's competitors may also succeed in developing
technologies and products that are more effective than any which have been or
are being developed by the Company or that render the Company's technologies or
products obsolete or noncompetitive. The Company's competitors may also
succeed in obtaining patent protection or other intellectual property rights
that would block the Company's ability to develop its potential products, or in
obtaining regulatory approval for the commercialization of their products more
rapidly or effectively than the Company. Finally, many of these competitors
have substantially greater research and development capabilities, clinical,
manufacturing, regulatory and marketing experience and financial and managerial
resources than the Company.
Dependence on Patents and Proprietary Technology. The biotechnology,
medical diagnostics and pharmaceutical industries place considerable importance
on the Company's obtaining patent and trade secret protection for new
technologies, products and processes, and the Company's success will depend, in
part, on its ability to obtain patent protection for its products and
manufacturing processes, preserve its trade secrets and operate without
infringing the proprietary rights of third parties. In addition to the
Company's own patents and patent applications, a number of institutions have
exclusively licensed rights to certain patents and patent applications to the
Company.
The Company is conducting research and expects to seek additional
patents in the future, but there can be no assurance as to its success or the
timeliness in obtaining any such patents or as to the breadth or degree of
protection which any such patents will afford the Company or not be challenged,
invalidated or infringed. Furthermore, there can be no assurance that others
will not independently develop similar products and processes, duplicate any of
the Company's products or, if patents are issued to the Company, design around
such patents. In
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addition, the Company could incur substantial costs in defending itself in
suits brought against it or in suits in which the Company may assert its
patents against others. If the outcome of any such litigation is adverse to
the Company, the Company's business could be adversely affected.
In addition, the Company may be required to obtain licenses to patents
or other proprietary rights of third parties. No assurance can be given that
any licenses required under any such patents or proprietary rights would be
made available on terms acceptable to the Company, if at all. If the Company
does not obtain such licenses, it could encounter delays in product market
introductions while it attempts to design around such patents or other rights,
or be unable to develop, manufacture or sell such products.
The Company also seeks to protect its proprietary technology,
including technology which may not be patented or patentable, in part by
confidentiality agreements and, if applicable, inventors' rights agreements
with its collaborators, advisors, employees and consultants. There can be no
assurance that these agreements will not be breached, that the Company will
have adequate remedies for any breach, or that the Company's trade secrets will
not otherwise be disclosed to, or discovered by, competitors. Moreover, the
Company conducts a significant amount of research through academic advisors and
collaborators who are prohibited from entering into confidentiality or
inventors' rights agreements by their academic institutions.
Dependence on Reimbursement. In both the United States and elsewhere,
sales of most of the Company's products, if any, will be dependent in part on
the availability of reimbursement from third party payors, such as government
and private insurance plans. Third party payors are increasingly challenging
the prices charged for medical products and services. Moreover, the federal
government of the United States has made the containment of health care costs a
top priority. If the Company succeeds in bringing one or more products to
market, there can be no assurance that these products will be considered
cost-effective, that reimbursement will be available or, if available, that the
level of reimbursement will be sufficient to allow the Company to sell its
products on a profitable basis.
Exposure to Product Liability Claims. The Company's business exposes
it to potential product liability claims which are inherent in the testing,
manufacturing, marketing and sale of human therapeutic products. The Company
currently has liability insurance of limited coverage. There can be no
assurance that it will be able to maintain such insurance or obtain general
product liability insurance on acceptable terms or at reasonable costs or that
such insurance will be in sufficient amounts to provide the Company with
adequate coverage against potential liabilities.
Dependence Upon Key Personnel. The Company is dependent on the
members of its management and scientific staff, the loss of one or more of whom
could have a material adverse effect on the Company. The Company also depends
on its scientific collaborators and advisors, all of whom have commitments that
may limit their availability to the Company. In addition, the Company believes
that its future success will depend in large part upon its ability to attract
and retain highly skilled scientific, managerial and marketing personnel,
particularly as the Company expands its activities in clinical trials, the
regulatory approval process and sales and manufacturing. The Company faces
significant competition for such personnel and from other companies, research
and academic institutions, government entities and other organizations. There
can be no assurance that the Company will be successful in hiring or retaining
the personnel it requires for continued growth. The failure to hire and retain
such personnel could materially and adversely affect the Company's prospects.
Shares Eligible for Future Sale. Future sales of Common Stock in the
public market by existing stockholders could have an adverse effect on the
price of the Common Stock. In addition, the Company has registered the shares
of Common Stock issued under its Amended and Restated 1991 Stock Compensation
Plan and approximately 2.3 million shares of Common Stock are presently
eligible for sale upon exercise of currently outstanding options.
Volatility of Stock Price. The market price of the shares of Common
Stock, like that of the common stock of many other early-stage biotechnology
companies, may be highly volatile. Factors such as announcements of
technological innovations or new commercial products by the Company or its
competitors, disclosure of results of clinical testing or regulatory
proceedings, governmental regulation and approvals, developments in patent or
other proprietary rights, public concern as to the safety of products developed
by the Company and general market conditions may have a significant effect on
the market price of the Common Stock. In addition, the stock market has
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experienced and continues to experience extreme price and volume fluctuations
which have effected the market price of many biotechnology companies and which
have often been unrelated to the operating performance of these companies.
These broad market fluctuations, as well as general economic and political
conditions, may adversely effect the market price of Common Stock.
THE COMPANY
T Cell Sciences, Inc. ("T Cell Sciences" or "TCS" or the "Company") is
an emerging biopharmaceutical company developing treatments for diseases caused
by misregulation of the body's natural defense systems. TCS is developing
products for diseases of inflammation, and autoimmunity. TCS has completed a
Phase I clinical trial of its first complement inhibitor therapeutic, sCR1, in
patients at risk of developing adult respiratory distress syndrome ("ARDS") and
is conducting a second Phase I trial for reperfusion injury following a heart
attack. TCS, with its partner AB Astra ("Astra"), is also developing products
based on the T Cell antigen receptor for the treatment of autoimmune diseases.
The initial product candidates being developed with Astra are now in the
research and preclinical stage of development. T Cell Sciences' wholly owned
subsidiary, T Cell Diagnostics, Inc. ("T Cell Diagnostics" or "TCD") is
developing, manufacturing and marketing new classes of diagnostic products to
be used for the detection and monitoring of immune-related disorders such as
organ transplant rejection, autoimmune conditions and cancers and infections
such as HIV. TCD recently received marketing clearance from the U.S. Food and
Drug Administration ("FDA") to market TRAx(R) CD4 for CD4 T cell enumeration.
THERAPEUTICS:
One of the Company's major programs is the development of products
which inhibit a part of the immune system called the complement system. The
complement cascade is a major initiator of the body's defense system and in
certain situations triggers harmful inflammatory responses resulting in the
death of viable tissue. No treatment currently exists to inhibit the harmful
effects of complement mediated inflammation and other treatments for
inflammatory diseases do not directly address inflammation caused by complement
activation.
The Company's lead complement product is soluble complement receptor B
or sCR1 (product name, TP10). TCS recently completed a Phase I clinical trial
for TP10 in patients with acute lung injury at risk of developing ARDS. A
Phase II trial is now being planned to evaluate TP10 in ARDS patients. A
second Phase I trial is ongoing with the indication of reperfusion injury
following heart attacks. A Phase II trial in reperfusion injury is being
planned for early 1996. All development, marketing and manufacturing rights,
outside of Japan and Taiwan, to TP10 are owned by T Cell Sciences.
In addition to TP10, T Cell Sciences is developing several other
complement inhibitors, including sLex CR1, which combines complement inhibition
with cell adhesion inhibition. These product candidates, which are in
preclinical development, are proprietary to the Company.
T Cell Sciences' second major program therapeutic is focused on using
the Company's proprietary T cell antigen receptor (TCAR) technology to develop
treatments for autoimmune diseases such as rheumatoid arthritis, multiple
sclerosis, Crohn's disease and T cell cancers. The Company believes that use
of this technology will result in a new generation of immunosuppressive drugs
that selectively eliminate the function of specific T cell subgroups which are
thought to cause the disease while leaving the majority of T cells to perform
their normal function in the immune system.
In January 1992, T Cell Sciences entered into a joint development and
distribution agreement with Astra, to develop jointly TCS's TCAR technology and
products for the treatment of autoimmune diseases and T cell cancers. TCS and
Astra amended and restated this agreement in December 1993 to provide that TCS
will continue to develop TP12, a peptide, and Astra will assume development
responsibility for TM27, a humanized monoclonal antibody. Astra has worldwide
marketing rights to the products developed from the joint program and T Cell
Sciences will receive a percentage of net sales of the products.
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DIAGNOSTICS:
T Cell Diagnostics is developing new human immuno-diagnostic products,
which would provide earlier warning of disease and more effective ways to
monitor and direct therapy. TCD's lead product, TRAx(R) CD4, received marketing
clearance from the FDA in May 1995 and is now being launched through direct
sales efforts in the U.S. and distributors outside the U.S. TRAx CD4 is used for
enumerating the CD4+ T Cells in patients with infectious diseases, including
HIV. TCD plans to submit TRAx CD8, a companion product to TRAx CD4, to the FDA
as a 510(k) submission before the end of 1995. The potential market for TRAx
CD4 is approximately $75 million in the U.S. and Europe. In clinical trials
conducted to support the Company's submission for clearance, TRAx CD4 provided
substantially equivalent results to those obtained from flow cytometry, the
method currently used to enumerate CD4 T cells. However, TRAx CD4 is a less
expensive alternative to flow cytometry, is more accessible to laboratories with
cell enumeration needs, has sample handling benefits and is more precise. For
these reasons, T Cell Diagnostics believes TRAx CD4 has distinct marketing
advantages over flow cytometry. Yamanouchi Pharmaceutical Co., Ltd. has rights
to market TRAx products in Japan and Taiwan. T Cell Diagnostics is evaluating
different types of relationships with distributors and automated equipment
partners to maximize the penetration of different markets for the TRAx products.
In addition to the TRAx product line, T Cell Diagnostics presently
sells approximately 40 products in the preclinical research market through
direct sales and distributors.
PATENTS:
T Cell Sciences has an extensive patent portfolio supporting its
therapeutic and diagnostic efforts. The Company is the owner or licensee of
over 200 patents and pending applications around the world, including 25 United
States patents. Patent rights in the area of complement molecules include an
issued United States patent which claims the nucleic acid sequences of
recombinant soluble CR1 (TP10) and its fragments. T Cell Sciences also owns
rights to a number of other patent applications relating to TP10, sCR1/SLex and
other complement inhibitor molecules. Issued and pending T cell receptor
patent rights cover the DNA, protein, and antibodies relating to the alpha,
beta, gamma and delta chains of the T cell antigen receptor. T Cell
Diagnostics is the owner of a number of patent rights relating to TRAx CD4 and
CD8, other applications of the TRAx product technologies, and new diagnostic
methods and products.
The Company is a Delaware corporation founded in 1983. The Company's
principal offices and laboratories are located at 115 Fourth Avenue, Needham,
Massachusetts 02194 and its telephone number is 617-433-0771.
USE OF PROCEEDS
The Company will not receive any proceeds from the sale of the Shares
by the Selling Stockholders.
RECENT DEVELOPMENTS
Certain Shares covered by this Prospectus were acquired by the Selling
Stockholders from the Company in private placement transactions. Certain
shares of Common Stock were purchased in a private placement transaction
pursuant to the Stock Purchase Agreements, dated as of October 27, 1995 (the
"October Stock Purchase Agreements") at a price per share of 20% below the
average of the high and low trading prices of the Common Stock on the Nasdaq
National Market on the five trading days preceding the Commitment Date (as
defined therein) of the October Stock Purchase Agreements, which price per share
as of the date of the October Stock Purchase Agreement was $2.825. In the
October Stock Purchase Agreements, the Company agreed to bear all expenses in
connection with the registration and sale of Shares and up to $2,500 of the
outside counsel fees and expenses of the Selling Stockholders who acquired
Shares pursuant to the October Stock Purchase Agreements (the "October Selling
Stockholders").
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Certain Shares covered by this Prospectus were acquired by the
Selling Shareholders from the Company in a separate private placement
transaction pursuant to the Stock Purchase Agreements, dated as of November
6, 1995 (the "November Stock Purchase Agreements") at a price per share of
$2.50. In the November Stock Purchase Agreements, the Company agreed to bear
all expenses in connection with the registration and sale of Shares (other than
underwriting discounts and selling commissions and the fees and expenses of
counsel and other advisors to the Selling Stockholders). The Company entered
into a Placement Agency Agreement dated as of November 2, 1995 with Allen &
Company Incorporated ("Allen & Company") pursuant to which the Company will pay
Allen & Company a commission of $0.10 per share of Common Stock purchased
by certain investors pursuant to the November Stock Purchase Agreements. In
connection with the Placement Agency Agreement, the Company has also agreed to
pay up to $5,000 of Allen & Company's outside counsel fees and expenses. See
"Plan of Distribution."
Because certain Selling Stockholders have purchased shares of Common
Stock pursuant to the November Stock Purchase Agreements (the "November Selling
Stockholders") prior to the Closing Date (as defined therein) of the October
Stock Purchase Agreements at a lower price per share than the $2.825 price per
share reflected in the October Stock Purchase Agreements, the October Selling
Stockholders will receive additional shares of Common Stock at no additional
cost. This issuance of additional shares of Common Stock to the October
Selling Stockholders is designed to result in the October Selling Shareholders
receiving the same price per share as the November Selling Stockholders.
Certain Shares covered by this Prospectus will be acquired by the
Selling Stockholders from the Company through the exercise of warrants for
shares of Common Stock (the "Warrantholders"). These warrants were issued to
these Selling Stockholders in connection with a private placement of Class B
Preferred Stock in December 1985. As consideration for the Company's
agreement to register shares of Common Stock issuable upon the exercise of
these warrants, the Warrantholders have expressed their intent to exercise
their warrants at the exercise price of $1.65 per share prior to the December
13, 1995 expiration date of such warrants.
Each Selling Stockholder represented in its respective Stock Purchase
Agreement or in its agreement with the Company that it was purchasing its
Shares from the Company or exercising its warrants for Shares of the Company
without any present intention of effecting a distribution of those Shares. In
recognition of the fact, however, that investors may desire to sell their
Shares when they consider appropriate, and in accordance with its agreement
in the respective Stock Purchase Agreements and its agreement with the
Warrantholders, the Company has filed with the Commission a registration
statement on Form S-3 (of which this Prospectus is a part, the "Registration
Statement") with respect to the sale of the Shares by the Selling Stockholders
from time to time on the Nasdaq National Market System or in negotiated
transactions. The Company will prepare and file such amendments and
supplements to the Registration Statement as may be necessary to keep it
effective for a period not exceeding three years or such shorter period which
will terminate when all the Shares covered by such Registration Statement
have been sold pursuant to such Registration Statement or withdrawn. The
Selling Shareholders (with the exception of the Selling Shareholders who have
acquired Shares through the exercise of warrants) agree to hold their Shares
for a period of thirty (30) days following the closing date of the transactions
contemplated by the respective Stock Purchase Agreements, which is the filing
date of the Registration Statement of which this Prospectus is a part.
SELLING STOCKHOLDERS
The Shares are to be offered by and for the respective accounts of the
Selling Stockholders. The following table sets forth the name and the number
of shares of Company Common Stock to be offered by each Selling Stockholder.
Number of Shares of Number of Shares Percentage of Shares
Common Stock Beneficially of Common Stock of Common Stock
Selling Stockholder Owned Prior to the Offering offered hereby after the Offering
- ------------------- --------------------------- ---------------------- ------------------------
Allen & Company Incorporated(1) 359,928 300,000 3.35%
GFL Advantage Fund Limited -- 500,000 2.54%
GFL Performance Fund Limited -- 400,000 2.03%
Bruce Allen -- 100,000 *
American Diversified
Enterprises Inc. -- 100,000 *
Donald R. Keough -- 50,000 *
SMALLCAP World Fund, Inc. -- 800,000 4.06%
Cook & CIE, S.A. -- 300,000 1.13%
Aetna Life & Casualty Co.(2) 71,776 151,297 --
F. Daniel Frost (2) -- 40,346 --
Allenwood Ventures, Inc.(2) -- 20,173 --
- --------------
* Denotes less than 1%.
(1) Allen & Company Incorporated has acted as a placement agent with
respect to some of the shares of Common Stock purchased by certain of the
November Selling Stockholders. John Simon, a member of the Company's Board of
Directors, is a Managing Director and Executive Vice President of Allen &
Company.
(2) Denotes Selling Shareholders who may acquire shares of Common Stock upon the
exercise of warrants at an exercise price of $1.65 per share; since the warrants have
not been or may not ultimately be exercised, no calculation has been made based
on ownership after exercise.
8
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Except as set forth above, the Selling Stockholders have not held any
position or office with, been employed by, or otherwise had a material
relationship with the Company or any of its predecessors or affiliates.
PLAN OF DISTRIBUTION
Shares of Common Stock covered hereby may be offered and sold from
time to time by the Selling Stockholders. The Selling Stockholders will act
independently of the Company in making decisions with respect to the timing,
manner and size of each sale. Such sales may be made in transactions in the
Nasdaq National Market System or otherwise at prices related to the then
current market price or in negotiated transactions. The Shares may be sold by
one or more of the following methods: (a) purchases by the broker-dealer as
principal and resale by such broker or dealer for its account pursuant to this
Prospectus; (b) ordinary brokerage transactions and transactions in which the
broker solicits purchasers; and (c) block trades in which the broker-dealer so
engaged will attempt to sell the Shares as agent but may position and resell a
portion of the block as principal to facilitate the transaction. The Company
has been advised by the Selling Stockholders that they have not, as of the date
hereof, made any arrangements relating to the distribution of the Shares
covered by this Prospectus. In effecting sales, broker-dealers engaged by the
Selling Stockholders may arrange for other broker-dealers to participate.
Broker-dealers will receive commissions or discounts from the Selling
Stockholders in amounts to be negotiated immediately prior to the sale.
In offering the Shares of Common Stock covered hereby, the Selling
Stockholders and any broker-dealers who execute sales for the Selling
Stockholders may be deemed to be "underwriters" within the meaning of the
Securities Act in connection with such sales, and any profits realized by the
Selling Stockholders and the compensation of such broker-dealer may be deemed
to be underwriting discounts and commissions under the Securities Act.
The Company has agreed to indemnify each Selling Stockholder against
any liabilities, under the Securities Act or otherwise, arising out of or based
upon any untrue or alleged untrue statement of a material fact in the
Registration Statement or this Prospectus or by any omission of a material fact
required to be stated therein except to the extent that such liabilities arise
out of or are based upon any untrue or alleged untrue statement or omission in
any information furnished in writing to the Company by the Selling Stockholder
expressly for use in the Registration Statement.
LEGAL MATTERS
The validity of the issuance of the Shares offered hereby will be
passed upon for the Company by its counsel, Goodwin, Procter & Hoar, Exchange
Place, 24th Floor, Boston, Massachusetts 02109.
EXPERTS
The consolidated financial statements and schedule of T Cell Sciences,
Inc. and subsidiary included in the Company's Annual Report to Stockholders on
Form 10-K for the year ended December 31, 1993 and the eight months ended
December 31, 1992, have been incorporated by reference herein and in the
registration statement in reliance upon the report of KPMG Peat Marwick LLP,
independent certified public accountants, incorporated by reference herein and
upon the authority of said firm as experts in accounting and auditing.
The consolidated financial statements incorporated in this Prospectus
by reference to the Annual Report to Stockholders on Form 10-K of T Cell
Sciences, Inc. for the year ended December 31, 1994 have been so incorporated
in reliance on the report of Price Waterhouse LLP, independent accountants,
given on the authority of said firm as experts in auditing and accounting.
9
12
================================================================================
NO DEALER, SALESMAN OR OTHER PERSON IS AUTHORIZED TO GIVE ANY
INFORMATION OR TO MAKE ANY REPRESENTATIONS NOT CONTAINED IN THIS PROSPECTUS IN
CONNECTION WITH THE OFFER MADE HEREBY, AND, IF GIVEN OR MADE, SUCH INFORMATION
OR REPRESENTATIONS MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE
COMPANY OR ANY UNDERWRITER. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO
SELL OR A SOLICITATION OF AN OFFER TO BUY THE SECURITIES OFFERED HEREBY TO ANY
PERSON IN ANY STATE OR OTHER JURISDICTION IN WHICH SUCH OFFER OR SOLICITATION
WOULD BE UNLAWFUL. THE DELIVERY OF THIS PROSPECTUS AT ANY TIME DOES NOT IMPLY
THAT INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY TIME SUBSEQUENT TO ITS
DATE.
_________________
TABLE OF CONTENTS
PAGE
----
The Company . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Use of Proceeds . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Recent Developments . . . . . . . . . . . . . . . . . . . . . . . . . 7
Selling Stockholders . . . . . . . . . . . . . . . . . . . . . . . . 8
Plan of Distribution . . . . . . . . . . . . . . . . . . . . . . . . 8
Legal Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Experts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
================================================================================
================================================================================
2,761,816 Shares
T CELL SCIENCES
COMMON STOCK
_________________
PROSPECTUS
_________________
November __, 1995
================================================================================
10
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PART II.
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION. (1)
The following are the estimated expenses of issuance and distribution of the
shares registered hereunder on Form S-3:
SEC Registration fee . . . . . . . . . . . . . . . . . . . . $ 2,857
NASDAQ listing fee . . . . . . . . . . . . . . . . . . . . . $ 17,500
Legal fees and expenses . . . . . . . . . . . . . . . . . . $ 50,000
Miscellaneous(2) . . . . . . . . . . . . . . . . . . . . . . $175,000
Total . . . . . . . . . . . . . . . . . . . . . . . .
=$245,357
- ----------
(1) The amounts set forth above, except for the SEC Registration Fee and the
Nasdaq Listing Fee, are estimated.
(2) Includes $165,000 commission paid to Allen & Company pursuant to the
Placement Agency Agreement, dated as of November 2, 1995.
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
SECURITIES AND EXCHANGE COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES
ACT LIABILITIES
Section 145 of the General Corporation Law of Delaware permits
indemnification of directors, officers and employees of a corporation under
certain conditions and subject to certain limitations. Article FIFTH of the
registrant's Amended and Restated By-Laws contains provisions for the
indemnification of directors, officers and employees within the limitations
permitted by Section 145.
The registrant carries a directors' and officers' liability insurance
policy which provides for payment of expenses of the registrant's directors and
officers in connection with threatened, pending or completed actions, suits or
proceedings against them in their capacities as directors and officers, in
accordance with the registrant's Amended and Restated By-Laws and the Delaware
General Corporation Law. In addition, Article SIXTH of the Third Restated
Certificate of Incorporation of the registrant protects a director of the
registrant against any personal liability to the registrant or its stockholders
for monetary damages for breach of fiduciary duty as a director, except for
liability (i) for any breach of the director's duty of loyalty to the
registrant or its stockholders, (ii) for acts or omissions not in good faith or
which involve intentional misconduct or a knowing violation of law, (iii) under
Section 174 of the Delaware General Corporation Law, or (iv) for any
transaction from which the director derived any improper benefit.
ITEM 16. EXHIBITS.
EXHIBIT
NO. DESCRIPTION
- ------- -----------
5 Opinion of Goodwin, Procter & Hoar.*
10.1 Form of Stock Purchase Agreement dated as of October 27, 1995
between the Company and the Purchasers.*
10.2 Form of Stock Purchase Agreement dated as of November 3,
1995, between the Company and the Purchasers.*
23.1 Consent of Price Waterhouse LLP.*
23.2 Consent of KPMG Peat Marwick LLP.*
23.3 Consent of Goodwin, Procter & Hoar (included in Exhibit 5).*
24 Power of Attorney (included on signature page).*
* Previously filed.
1
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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. To include any material information with respect
to the plan of distribution not previously disclosed in the
registration statement or any material change to such
information in the registration statement.
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each 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.
B. 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
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.
C. Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the registrant pursuant to the provisions
described under Item 15 above, or otherwise, 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 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.
2
15
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
registrant has duly caused this Amendment to the Registration Statement to be
signed on its behalf by the undersigned, thereunto duly authorized, in the
Town of Needham, Commonwealth of Massachusetts, on the 20th day of
November, 1995.
T CELL SCIENCES, INC.
By: /s/ Alan W. Tuck
-------------------------------------
Alan W. Tuck
President and Chief Executive Officer
Pursuant to the requirements of the Securities Act of 1933, this
Amendment to the Registration Statement has been signed by the following
persons in the capacities and on the dates indicated.
Signature Title Date
--------- ----- ----
/s/ Alan W. Tuck President, Chief Executive Officer November 20, 1995
- ------------------------------- & Chief Financial Officer & Director
(Alan W. Tuck)
* Chairman of the Board November 20, 1995
- ------------------------------- & Director
(James D. Grant)
* Vice Chairman of the Board & November 20, 1995
- ------------------------------- Director
(Patrick C. Kung)
* Director November 20, 1995
- -------------------------------
(John P. Munson)
* Director November 20, 1995
- -------------------------------
(John Simon)
* Director November 20, 1995
- -------------------------------
(Thomas R. Ostermueller)
By: /s/ Alan W. Tuck
- -------------------------------
Alan W. Tuck
Attorney-in-Fact
