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As filed with the Securities and Exchange Commission on July 8, 1998.
Registration No. 333-56441
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 1
TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
THE IMMUNE RESPONSE CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 33-0255679
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
5935 Darwin Court
Carlsbad, California 92008
(760) 431-7080
(Address, including zip code, and telephone number, including
area code of registrant's principal executive offices)
Copies to:
DENNIS J. CARLO, Ph.D. THOMAS E. SPARKS, JR., ESQ.
President and Chief Executive Officer Pillsbury Madison & Sutro LLP
The Immune Response Corporation P. O. Box 7880
5935 Darwin Court San Francisco, CA 94120-7880
Carlsbad, California 92008 (415) 983-1000
(760) 431-7080
(Name, address, including zip code, and
telephone number, including area code,
of agent for service)
Approximate date of commencement of proposed sale to the public: From time
to time after the effective date of this Registration Statement as determined
by the Selling Stockholder.
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, please check the following box: [x]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following
box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering: [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering: [ ]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box: [ ]
The registrant hereby amends this Registration Statement on such date or
dates as may be necessary to delay its effective date until the registrant
shall file a further amendment which specifically states that this
Registration Statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act of 1933 or until the Registration
Statement shall become effective on such date as the Commission, acting
pursuant to said Section 8(a), may determine.
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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 buy 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.
SUBJECT TO COMPLETION, DATED JULY 8, 1998
THE IMMUNE RESPONSE CORPORATION
1,700,000 SHARES OF COMMON STOCK
(PAR VALUE $0.0025 PER SHARE)
________
This Prospectus covers the public offering, which is not being
underwritten, of 1,700,000 shares (the "Shares") of Common Stock, $0.0025 par
value, of The Immune Response Corporation ("Immune Response" or the
"Company") issuable to certain persons named in this Prospectus (the "Selling
Stockholders"). The Shares are issuable upon conversion of, or upon issuance
of dividends on, 200 shares of Series F Convertible Preferred Stock sold by
the Company to certain accredited investors in a private placement in April
1998 for gross proceeds of $10,000,000 (the "Private Placement"). The Series
F Convertible Preferred Stock is convertible into Common Stock initially at a
conversion price equivalent to $14.07 per share of Common Stock. At the
initial conversion price, 710,732 shares of Common Stock are issuable upon
conversion of the 200 shares of Series F Convertible Preferred Stock. If
prior to April 24, 1999 the average of the closing bid prices for the Common
Stock during any 20 consecutive trading day period subsequent to May 28,
1998, and the closing bid price for a share of Common Stock on April 24, 1999
is not greater than $14.07, then the conversion price of the Series F
Convertible Preferred Stock will be adjusted downward on April 24, 1999 (or
sooner if the Company issues Common Stock at less than $14.07 per share prior
to April 24, 1999) and quarterly thereafter. The new lower conversion price
will be equal to the average of the closing bid prices of the Common Stock
during the 30 consecutive trading days immediately preceding the date of
adjustment of the conversion price unless the conversion price then in effect
is lower, in which case the conversion price would not be adjusted. The
conversion price of the Series F Preferred Stock will also be adjusted for
events such as subdivisions or combinations of the Common Stock and
reorganizations, reclassifications, consolidations, merger or sale of the
Company. The Series F Convertible Preferred Stock bears a dividend of 7.5%
per annum, which is generally payable in shares of Common Stock. The Company
is obligated to use its best efforts to keep the registration statement, of
which this Prospectus is a part, effective until the earlier of (i) the date
as of which the Selling Stockholders may sell all of their Shares without
restriction pursuant to Rule 144(k) promulgated under the Securities Act of
1933 (or successor thereto) or (ii) the date on which (A) the Selling
Stockholders have sold all their shares and (B) none of the shares of Series
F Preferred Stock issued in the Private Placement is outstanding.
The Company's Common Stock is traded on the Nasdaq National Market under
the symbol "IMNR." On July 7, 1998, the last reported sale price of the
Company's Common Stock on the Nasdaq National Market was $13.125.
The Shares are being offered on behalf of the Selling Stockholders, and
the Company will not receive any proceeds from the offering. The Shares may
be sold or distributed from time to time by the Selling Stockholders, or by
pledgees, donees or transferees of, or other successors in interest to, the
Selling Stockholders, directly to one or more purchasers (including pledgees)
or through brokers, dealers or underwriters who may act solely as agents or
may acquire Shares as principals, at market prices prevailing at the time of
sale, at prices related to such prevailing market prices, at negotiated
prices, or at fixed prices, which may be changed. The distribution of the
Shares may be effected in one or more of the following methods: (i) ordinary
brokers' transactions, which may include long or short sales; (ii)
transactions involving cross or block trades or otherwise on the Nasdaq
National Market or such other exchange or market on which the Common Stock is
listed for trading; (iii) purchases by brokers, dealers or underwriters as
principal and resale by such purchasers for their own accounts pursuant to
this Prospectus; (iv) "at the market" to or through market makers or into an
existing market for the Common Stock; (v) in other ways not involving market
makers or established trading markets, including direct sales to purchasers or
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sales effected through agents; (vi) through transactions in options, swaps or
other derivatives (whether exchange-listed or otherwise); or (vii) any
combination of the foregoing, or by any other legally available means. In
addition, the Selling Stockholders or their successors in interest may enter
into hedging transactions with broker-dealers who may engage in short sales
of Shares in the course of hedging the positions they assume with the Selling
Stockholders. The Selling Stockholders or their successors in interest may
also enter into option or other transactions with broker-dealers that require
the delivery by such broker-dealers of the Shares, in which Shares may be
resold thereafter pursuant to this Prospectus. The Selling Stockholders or
their successors in interest may also pledge shares as collateral for margin
accounts and such shares could be resold pursuant to the terms of such
accounts. See "Plan of Distribution."
All expenses (estimated to be $60,000) of the registration of the Common
Stock covered by this Prospectus will be borne by the Company pursuant to a
preexisting agreement, except that the Company will not pay any Selling
Stockholder's underwriting discounts or selling commissions.
The Company will not receive any proceeds from the sale of the Shares.
The Selling Stockholders and any broker-dealers, agents or underwriters that
participate with the Selling Stockholders in the distribution of the Shares
may be determined to be "underwriters" within the meaning of Section 2(11) of
the Securities Act of 1933, as amended (the "Securities Act"), and any
commissions received by them and any profit on the sale of the Shares
purchased by them may be deemed to be underwriting commissions or discounts
under the Securities Act. See "Selling Stockholders" and "Plan of
Distribution."
______________
THESE SECURITIES INVOLVE A HIGH DEGREE OF RISK. SEE "RISK FACTORS"
COMMENCING ON PAGE 5 OF THIS PROSPECTUS.
______________
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.
______________
The date of this Prospectus is July __, 1998
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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 reports, proxy statements and other information
with the Securities and Exchange Commission (the "Commission"). Such reports,
proxy statements and other information filed by the Company can be (i)
inspected and copied at the public reference facilities maintained by the
Commission at 450 Fifth Street, N.W., Judiciary Plaza, Washington, D.C., and
at the Commission's Chicago Regional Office, 500 West Madison Street,
Chicago, Illinois; and New York Regional Office, 7 World Trade Center, New
York, New York and (ii) accessed via a Web site maintained by the Commission
(http://www.sec.gov). Copies of such material can also be obtained from the
Public Reference Section of the Commission at 450 Fifth Street, N.W.,
Judiciary Plaza, Washington, D.C. 20549 at prescribed rates.
The Company has filed with the Commission a Registration Statement on
Form S-3 (Commission File No. 333-56441) under the Securities Act, with
respect to the Common Stock offered hereby (the "Registration Statement").
This Prospectus does not contain all of the information set forth in the
Registration Statement and the exhibits and schedules thereto. For further
information with respect to the Company and the Common Stock, reference is
made to the Registration Statement and the exhibits and schedules thereto.
Statements contained in this Prospectus as to the contents of any contract or
other document are not necessarily complete, and, in each instance, reference
is made to the copy of such contract or document filed as an exhibit to the
Registration Statement, each such statement being qualified in all respects
by such reference. Copies of the Registration Statement, including all
exhibits thereto, may be obtained from the Commission's principal office in
Washington, D.C. upon payment of the fees prescribed by the Commission, or
may be examined without charge at the offices of the Commission.
DOCUMENTS INCORPORATED BY REFERENCE
The following documents previously filed with the Commission are hereby
incorporated by reference into this Prospectus:
1. The Company's Annual Report on Form 10-K for the year ended
December 31, 1997 (File No. 0-18006);
2. The Company's Quarterly Report on Form 10-Q for the quarter ended
March 31, 1998;
3. The Company's Current Report on Form 8-K dated April 24, 1998;
4. The Company's Current Report on Form 8-K dated June 11, 1998;
5. The description of Immune Response Common Stock set forth in the
Registration Statement on Form 8-A filed on March 30, 1990; and
6. The description of the Preferred Stock Purchase rights for Series E
Participating Preferred Stock, par value $0.001, set forth in the Registration
Statement on Form 8-A filed on March 4, 1992.
All documents subsequently filed by Immune Response pursuant to Section
13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the termination of the
offering to which this Prospectus relates shall be deemed to be incorporated
by reference into this Prospectus and to be part of this Prospectus from the
date of filing thereof.
Any statement contained in a document incorporated by reference herein
shall be deemed to be modified or superseded for purposes of this Prospectus
and the Registration Statement of which it is a part to the extent that a
statement contained herein or in any other subsequently filed document which
also is incorporated herein modifies or replaces such statement. Any
statement so modified or superseded shall not be deemed, in its unmodified
form, to constitute a part of this Prospectus or such Registration Statement.
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Upon written or oral request, the Company will provide without charge to
each person to whom a copy of this Prospectus is delivered a copy of the
documents incorporated by reference herein (other than exhibits to such
documents unless such exhibits are specifically incorporated by reference
therein). Requests should be submitted in writing or by telephone at (760)
431-7080 to The Immune Response Corporation, at the principal executive
offices of the Company, 5935 Darwin Court, Carlsbad, California 92008.
SPECIAL NOTE REGARDING FORWARD-LOOKING INFORMATION
When used in this Prospectus, the words "intends to," "believes,"
"anticipates," "expects" and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are based
largely on the Company's expectations and are subject to a number of risks
and uncertainties, certain of which are beyond the Company's control. For a
discussion of certain of such risks, see "Risk Factors." These
forward-looking statements speak only as of the date of this Prospectus. The
Company expressly disclaims any obligation or undertaking to release publicly
any updates or revisions to any forward-looking statement contained herein to
reflect any change in the Company's expectations with regard thereto or any
change in events, conditions or circumstances on which any such statement is
based.
THE COMPANY
Immune Response is a biopharmaceutical company developing immune-based
therapies to induce specific T cell responses for the treatment of HIV,
autoimmune diseases and cancer. The Company is conducting clinical trials
for its immune-based therapies for HIV, rheumatoid arthritis, psoriasis,
multiple sclerosis, colon cancer and brain cancer and preclinical studies for
melanoma and prostate cancers. In addition, the Company is developing a
targeted delivery technology for gene therapy which is designed to enable the
intravenous injection of genes for delivery directly to the liver. The
Company's gene therapy program is currently focused on diseases of the liver
and is in preclinical studies for the treatment of hemophilia and hepatitis.
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RISK FACTORS
UNCERTAINTY OF PRODUCT DEVELOPMENT AND CLINICAL TESTING
The Company has not completed the development of any products and there can
be no assurance any products will be successfully developed. The Company has
been in existence since 1986, and to date only six of its product candidates
have entered clinical trials. The Company's potential immune-based therapies
for HIV, autoimmune disease, cancer and gene therapy products currently under
development will require significant additional research and development efforts
and regulatory approvals prior to potential commercialization. To achieve
profitable operations, the Company must successfully develop, manufacture,
introduce and market products. The Company's potential products may not prove
to be safe and effective in clinical trials, United States Food and Drug
Administration ("FDA") or other regulatory approvals may not be obtained and
such products may not achieve market acceptance.
The Company's potential HIV immune-based therapy, REMUNE, is in a Phase III
clinical endpoint trial designed to provide evidence of efficacy based on
clinical endpoints. The results of such clinical trial may not demonstrate that
REMUNE is safe and efficacious and, even if the results of the clinical trial
are considered successful by the Company, the FDA may require the Company to
conduct additional large scale clinical trials with REMUNE before the FDA will
consider approving REMUNE for commercial sale. Failure to successfully complete
the Phase III clinical endpoint trial in a timely fashion and a failure to
obtain FDA approval of REMUNE will materially and adversely affect the Company.
The results of the Phase III trial may not be consistent with Phase II
results. Even if the results of the Phase III trial are consistent with the
results of the Phase II trial, the FDA may not approve REMUNE for marketing. In
addition, REMUNE is being tested in a Phase II clinical trial in Thailand, in a
pediatric Phase I clinical trial in the United States and in combination trials
with approved HIV therapies in the United States and Spain. Failure of these
trials to demonstrate the safety and effectiveness of REMUNE could have a
material adverse effect on the regulatory approval process for this potential
product.
The Company's other potential immune-based therapies and gene therapy
technologies are at a much earlier stage of development than REMUNE. The
Company's gene therapy technology and certain of its technologies for the
treatment of cancer have not yet been tested in humans and human testing of
potential products based on such technologies may not be permitted by regulatory
authorities and, even if human testing is permitted, products based on such
technologies may not be developed and shown to be safe or efficacious.
Potential immune-based therapies based on certain of the Company's autoimmune
technologies and certain of its cancer technologies are at an early stage of
clinical testing and such products may not be shown to be safe, efficacious or
receive regulatory approval.
The results of the Company's preclinical studies and clinical trials may
not be indicative of future clinical trial results. A commitment of substantial
resources to conduct time-consuming research, preclinical studies and clinical
trials, including the REMUNE Phase III clinical endpoint trial will be required
if the Company is to develop any products. Delays in planned patient enrollment
in the Company's current clinical trials or future clinical trials may result in
increased costs, program delays or both. None of the Company's potential
products may prove to be safe and effective in clinical trials, FDA or other
regulatory approvals may not be obtained or such products may not achieve market
acceptance. Any products resulting from these programs are not expected to be
successfully developed or commercially available for a number of years, if at
all.
Unacceptable toxicities or side effects may occur at any time in the course
of human clinical trials and, if any products are successfully developed and
approved for marketing, during commercial use of the Company's products. The
appearance of any such unacceptable toxicities or side effects could interrupt,
limit, delay or abort the development of any of the Company's products or, if
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previously approved, necessitate their withdrawal from the market. Furthermore,
disease resistance may limit the efficacy of the Company's potential products.
ADDITIONAL FINANCING REQUIREMENTS AND ACCESS TO CAPITAL
The Company will need to raise additional funds to conduct research and
development, preclinical studies and clinical trials necessary to bring its
potential products to market and establish manufacturing and marketing
capabilities. The Company anticipates that in 1998, the REMUNE clinical trials
will continue to represent a significant portion of the Company's overall
expenditures. The Company also anticipates that costs related to the
development of REMUNE will continue to increase as the Company approaches
possible commercialization. The anticipated costs with respect to REMUNE will
depend on many factors, including the results of interim analyses of the data
from the Phase III clinical endpoint trial, the availability of third party
reimbursement for expanded access protocols for REMUNE, the potential for
accelerated approval, the continuation of the Company's collaboration with
Agouron Pharmaceuticals, Inc. and certain other factors which will influence the
Company's determination of the appropriate continued investment of the Company's
financial resources in this program.
The Company's future capital requirements will depend on many factors,
including continued scientific progress in its research and development
programs, the scope and results of preclinical studies and clinical trials, the
time and costs involved in obtaining regulatory approvals, the costs involved in
filing, prosecuting and enforcing patent claims, competing technological and
market developments, the cost of manufacturing scale-up, effective
commercialization activities and arrangements and other factors not within the
Company's control. The Company intends to seek additional funding through
public or private financings, arrangements with corporate collaborators or other
sources. If funds are acquired through additional collaborations, the Company
will likely be required to relinquish some or all rights to products that the
Company may have otherwise developed itself. Adequate funds may not be
available when needed or on terms acceptable to the Company. Insufficient funds
may require the Company to scale back or eliminate some or all of its research
and development programs or license to third parties products or technologies
that the Company would otherwise seek to develop itself. The Company believes
that its existing resources, including interest thereon will enable the Company
to maintain its current and planned operations beyond 1998.
PATENTS AND PROPRIETARY TECHNOLOGY
The Company has filed, or participated as licensee, in the filing of a
number of patent applications in the United States and many international
countries. The Company files applications as appropriate for patents covering
its products and processes. The Company has been issued patents, or has
licensed patents, covering certain aspects of its proposed immune-based
therapies for HIV, autoimmune disease, cancer and gene therapy technologies.
The Company's success may depend in part on its ability to obtain patent
protection for its products and processes. The Company is aware that a group
working with Connetics Corporation has received a United States patent related
to autoimmune disease research that covers technology similar to that used by
the Company.
The Company may not be able to negotiate any necessary cross licenses, and
failure to do so could have a negative impact on the Company. The Company's
patent applications may not issue as patents and its issued patents, or any
patent that may be issued in the future, may not provide the Company with
adequate protection for the covered products, processes or technology.
The patent positions of biotechnology and pharmaceutical companies can be
highly uncertain, and involve complex legal and factual questions. Therefore,
the breadth of claims allowed in biotechnology and pharmaceutical patents cannot
be predicted. The Company also relies upon unpatented trade secrets and know
how, and others may independently develop substantially equivalent trade secrets
or know how. In addition, whether or not the Company's patents are issued, or
issued with limited coverage, others may receive patents which contain claims
applicable to the Company's product. Any of the Company's patents, or any
patents issued to the Company in the future, may not afford meaningful
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protection against competitors. Defending any such patent could be costly to
the Company, and the patent may not be held valid by a court of competent
jurisdiction.
The Company also relies on protecting its proprietary technology in part
through confidentiality agreements with its corporate collaborators, employees,
consultants and certain contractors. These agreements may be breached, the
Company may not have adequate remedies for any breach and the Company's trade
secrets may otherwise become known or independently discovered by its
competitors.
It is possible that the Company's products or processes will infringe, or
will be found to infringe, patents not owned or controlled by the Company, such
as the patent owned by Connetics Corporation. If any relevant claims of third-
party patents are upheld as valid and enforceable, the Company could be
prevented from practicing the subject matter claimed in such patents, or would
be required to obtain licenses or redesign its products or processes to avoid
infringement. Such licenses may not be available at all or on terms
commercially reasonable to the Company and the Company may not be able to
redesign its products or processes to avoid infringement. Litigation may be
necessary to defend against claims of infringement, to enforce patents issued to
the Company or to protect trade secrets. Such litigation could result in
substantial costs and diversion of management efforts regardless of the results
of such litigation and an adverse result could subject the Company to
significant liabilities to third parties, require disputed rights to be licensed
or require the Company to cease using such technology.
HISTORY OF OPERATING LOSSES
As of March 31, 1998, the Company had an accumulated deficit of $161.4
million. The Company has not generated revenues from the commercialization of
any products and expects to incur substantial net operating losses over the
next several years. The Company may not be able to generate sufficient product
revenue to become profitable at all or on a sustained basis. The Company
expects to have quarter-to-quarter fluctuations in expenses, some of which
could be significant, due to expanded research, development and clinical trial
activities.
LENGTHY APPROVAL PROCESS AND UNCERTAINTY OF GOVERNMENT REGULATORY REQUIREMENTS
Clinical testing, manufacture, promotion and sale of the Company's drug
products are subject to extensive regulation by numerous governmental
authorities in the United States, principally the FDA, and corresponding state
and foreign regulatory agencies. The Company believes that REMUNE and most of
its other potential immune-based therapies will be regulated by the FDA as
biological drug products under current regulations of the FDA. Biological
products must be shown to be safe, pure and potent (i.e., effective) and are
subject to the same regulatory requirements as nonbiological products under the
FDC Act, as amended by the FDA Modernization Act, except that a biological
product licensed under the Public Health Services Act ("PHS Act") is not
required to have an approved NDA under the Federal Food, Drug and Cosmetic Act
("FDC Act"). The FDA Modernization Act directed the FDA to take measures to
minimize the differences in the review and approval of marketing applications
for biological and nonbiological products. The FDA Modernization Act also made
significant revisions to the statutory requirements with regard to the approval
of new biological and nonbiological products. Among other things, the FDA
Modernization Act established a new statutory program for the approval of fast
track drugs, streamlined clinical research, and revised the content of product
approval applications and the FDA review process. The FDA is required to issue
regulations and guidelines in order to implement certain of these new
requirements. Until the FDA implements these regulations and guidelines, it is
impossible to predict the impact of the FDA Modernization Act on the review and
approval of any marketing applications that the Company may submit to the FDA.
The FDC Act, the PHS Act and other federal and state statutes and regulations
govern or influence the testing, manufacture, safety, effectiveness, labeling,
storage, recordkeeping, approval, advertising, distribution and promotion of
biological prescription drug products. Noncompliance with applicable
requirements can result in, among other things, fines, injunctions, seizure of
products, total or partial suspension of product marketing, failure of the
government to grant premarket approval, withdrawal of marketing approvals and
criminal prosecution.
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The regulatory process for new therapeutic drug products, including the
required preclinical studies and clinical testing, is lengthy and expensive and
there can be no assurance that necessary FDA clearances will be obtained in a
timely manner, if at all. The length of the clinical trial period and the
number of patients the FDA will require to be enrolled in the clinical trials in
order to establish the safety and efficacy of the Company's products are
uncertain. The Company may encounter significant delays or excessive costs in
its efforts to secure necessary approvals, and regulatory requirements are
evolving and uncertain. Future United States or foreign legislative or
administrative acts could also prevent or delay regulatory approval of the
Company's products. The Company may not be able to obtain the necessary
approvals for clinical trials, manufacturing or marketing of any of its products
under development. Even if commercial regulatory approvals are obtained, they
may include significant limitations on the indicated uses for which a product
may be marketed. In addition, a marketed product is subject to continual FDA
review. Later discovery of previously unknown problems or failure to comply
with the applicable regulatory requirements may result in restrictions on the
marketing of a product or withdrawal of the product from the market, as well as
possible civil or criminal sanctions.
The steps required before a biological drug product may be marketed in the
United States generally include preclinical studies and the filing of an IND
application with the FDA. Reports of results of preclinical studies and
clinical trials for biological drug products are submitted to the FDA in the
form of a Biologics Licensing Application ("BLA") for approval for marketing and
commercial shipment. Submission of a BLA does not assure FDA approval for
marketing. The BLA review process may take a number of years to complete,
although reviews of applications for treatments of AIDS, cancer and other life-
threatening diseases may be accelerated or expedited. Failure of the Company to
receive FDA marketing approval for REMUNE or any of its other products under
development on a timely basis could have a material adverse effect on the
Company's business, financial condition and results of operations. In addition
to obtaining approval for each biological drug product, an ELA usually must be
filed and approved by the FDA.
Among the other requirements for BLA approval is the requirement that
prospective manufacturers conform to the FDA's Good Manufacturing Practices
("GMP") requirements specifically for biological drugs, as well as for other
drugs. In complying with the FDA's GMP requirements, manufacturers must
continue to expend time, money and effort in production, recordkeeping and
quality control to assure that the product meets applicable specifications and
other requirements. Failure to comply with the FDA's drug GMP requirements
subjects the manufacturer to possible FDA regulatory action. The Company or its
contract manufacturers, if any, may not be able to maintain compliance with the
FDA's drug GMP requirements on a continuing basis. Failure to maintain such
compliance could have a material adverse effect on the Company's business,
financial condition and results of operations.
The Company believes its proprietary GeneDrug and cancer treatment
therapies will likely be regulated as biological products. As with the
Company's other potential products, the gene therapy and cancer products will be
subject to extensive FDA regulation throughout the product development process,
and any of these products may not be approved for marketing by the FDA on a
timely basis, if at all.
The FDA Modernization Act also amended the FDC Act to permit expanded
access to individuals and larger groups to unapproved new therapeutic and
diagnostic products. Although the new law largely codifies existing FDA
regulations in this area, it expands access to all investigational therapies
under certain conditions. Although the FDA has granted expanded access to
REMUNE for those patients who are ineligible to enroll in the Phase III clinical
endpoint trial, the FDA has to date not designated expanded access protocols for
REMUNE as "treatment" protocols. Either expanded access or a treatment protocol
designation might permit third party reimbursement of some of the costs
associated with making REMUNE available to patients in such an expanded access
context. The FDA may not determine that REMUNE meets all of the FDA's criteria
for use of an investigational drug for treatment use and, even if the product is
allowed for treatment use, third party payers may not provide reimbursement for
the costs of treatment with REMUNE.
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The FDA also has issued regulations to accelerate the approval of or to
expedite the review of new biological drug products for serious or life-
threatening illnesses that provide meaningful therapeutic benefit to patients
over existing treatments. Under the accelerated approval program, the FDA may
grant marketing approval for a biological or nonbiological drug product earlier
than would normally be the case. In addition to the accelerated approval
process, the FDA has established procedures designed to expedite the
development, evaluation and marketing of new therapies intended to treat persons
with life-threatening and severely debilitating illnesses, especially when no
satisfactory alternative therapy exists. In addition, the FDA Modernization Act
established a new statutory program for the approval of fast track drugs,
including biological products. The FDA may not consider REMUNE or any other of
the Company's products under development to be an appropriate candidate for
accelerated approval, expedited review or fast track designation.
To market any drug products outside of the United States, the Company is
also subject to numerous and varying foreign regulatory requirements,
implemented by foreign health authorities, governing the design and conduct of
human clinical trials and marketing approval. The approval procedure varies
among countries and can involve additional testing, and the time required to
obtain approval may differ from that required to obtain FDA approval. The
foreign regulatory approval process includes all of the risks associated with
obtaining FDA approval set forth above, and approval by the FDA does not ensure
approval by the health authorities of any other country.
TECHNOLOGICAL CHANGE AND COMPETITION
The biotechnology industry continues to undergo rapid change and
competition is intense in the fields of HIV, autoimmune disease, cancer and gene
therapy, and such competition is expected to increase. The Company will compete
with fully integrated pharmaceutical companies, small biotechnology companies,
universities and research organizations. Competitors may succeed in developing
technologies and products that are more effective than any which have been or
are being developed by the Company or which would render the Company's
technology and products obsolete and noncompetitive. Many of the Company's
competitors have substantially greater experience, financial and technical
resources and production, marketing and development capabilities than the
Company. Accordingly, certain of the Company's competitors may succeed in
obtaining regulatory approval for products more rapidly or effectively than the
Company. If the Company commences commercial sales of its products, it will
also be competing with respect to manufacturing efficiency and sales and
marketing capabilities, areas in which it currently has no experience.
Competitors may develop and commercialize more effective or affordable products.
DEPENDENCE ON THIRD PARTIES
The Company's strategy for the research, development and commercialization
of its products requires entering into various arrangements with corporate
collaborators, licensors, licensees and others, and the Company's commercial
success is dependent upon these outside parties performing their respective
contractual responsibilities, including the analysis of the data generated in
the Company's clinical trials. The amount and timing of resources such third
parties will devote to these activities may not be within the control of the
Company. There can be no assurance that such parties will perform their
obligations as expected and the failure of third parties to perform their
obligations would have a material adverse effect on the Company. Although the
Company has collaborative agreements with several universities and research
institutions, the Company's agreement with Bayer and its binding Letter of
Intent with Agouron Pharmaceuticals, Inc. are the only collaborative agreements
that provide the Company with contract revenue. These collaborations may not
result in the development of any commercial products. Immune Response intends
to seek additional collaborative arrangements to develop and commercialize
certain of its products. The Company may not be able to negotiate collaborative
arrangements on favorable terms, or at all, in the future and its current or
future collaborative arrangements may not be successful.
DEPENDENCE ON KEY PERSONNEL
Since its inception, Immune Response has relied on the technical and
management skills of its experienced staff. The Company does not maintain key
man life insurance on any of its personnel. The Company's success also
-9-
<PAGE>
depends in large part upon its ability to attract and retain highly qualified
scientific and management personnel. The Company faces competition for such
personnel from other companies, academic institutions, government entities
and other organizations. The Company may not be successful in hiring or
retaining requisite personnel.
LACK OF COMMERCIAL MANUFACTURING AND MARKETING EXPERIENCE
The Company has a manufacturing facility for REMUNE located in King of
Prussia, Pennsylvania, and a pilot manufacturing facility in Carlsbad,
California for its other products. The Company has not yet manufactured its
product candidates in commercial quantities. The Company may not be able to
make the transition from manufacturing clinical trial quantities to commercial
production quantities successfully or be able to arrange for contract
manufacturing. The Company believes it will be able to manufacture REMUNE for
initial commercialization, if the product obtains FDA approval, but it has not
yet demonstrated the capability to manufacture REMUNE in commercial quantities,
or its autoimmune disease, cancer and gene therapy treatments in large-scale
clinical or commercial quantities. The Company has no experience in the sales,
marketing and distribution of pharmaceutical products. The Company may not be
able to establish sales, marketing and distribution capabilities or make
arrangements with its collaborators, licensees or others to perform such
activities and such efforts may not be successful. The Company's products may
not be successfully commercialized even, if they are developed and approved for
commercialization.
The manufacture of the Company's products involves a number of steps and
requires compliance with stringent quality control specifications imposed by the
Company itself and by the FDA. Moreover, the Company's products can only be
manufactured in a facility that has undergone a satisfactory inspection by the
FDA. For these reasons, the Company would not be able quickly to replace its
manufacturing capacity if it were unable to use its manufacturing facilities as
a result of a fire, natural disaster (including an earthquake), equipment
failure or other difficulty, or if such facilities are deemed not in compliance
with the FDA's drug GMP requirements and the non-compliance could not be rapidly
rectified. The Company's inability or reduced capacity to manufacture its
products would have a material adverse effect on the Company's business and
results of operations.
The Company may enter into arrangements with contract manufacturing
companies to expand its own production capacity in order to meet requirements
for its products, or to attempt to improve manufacturing efficiency. If the
Company chooses to contract for manufacturing services and encounters delays or
difficulties in establishing relationships with manufacturers to produce,
package and distribute its finished products, clinical trials, market
introduction and subsequent sales of such products would be adversely affected.
Further, contract manufacturers must also operate in compliance with the FDA's
drug GMP requirements; failure to do so could result in, among other things, the
disruption of product supplies. Until recently, biologic product licenses could
not be held by any company unless it performed significant manufacturing
operations. The FDA recently amended its regulations in this regard, and the
Company believes that under these new regulations it can now hold licenses for
its biological products without performing significant manufacturing steps.
Nonetheless, the Company's potential dependence upon third parties for the
manufacture of its products may adversely affect the Company's profit margins
and its ability to develop and deliver such products on a timely and competitive
basis.
UNCERTAINTY OF PRODUCT PRICING, REIMBURSEMENT AND RELATED MATTERS
The Company's ability to earn sufficient returns on its products will
depend in part on the extent to which reimbursement for the costs of such
products and related treatments will be available from government health
administration authorities, private health coverage insurers, managed care
organizations and other organizations. Third party payors are increasingly
challenging the price of medical products and services. If purchasers or users
of the Company's products are not able to obtain adequate reimbursement for the
cost of using such products, they may forego or reduce such use. Significant
uncertainty exists as to the reimbursement status of newly approved health care
products, and adequate third party coverage may not be available. Failure to
obtain appropriate reimbursement would have a material adverse effect on the
Company.
-10-
<PAGE>
PRODUCT LIABILITY EXPOSURE
The Company faces an inherent business risk of exposure to product
liability and other claims in the event that the development or use of its
technology or prospective products is alleged to have resulted in adverse
effects. While the Company has taken, and will continue to take, what it
believes are appropriate precautions, there can be no assurance that it will
avoid significant liability exposure. Although the Company currently carries
product liability insurance for clinical trials, there can be no assurance that
the Company has sufficient coverage, or can obtain sufficient coverage, at a
reasonable cost. An inability to obtain product liability insurance at
acceptable cost or to otherwise protect against potential product liability
claims could prevent or inhibit the commercialization of products developed by
the Company. A product liability claim could have a material adverse effect on
the Company's business, financial condition and results of operations.
HAZARDOUS MATERIALS/ENVIRONMENTAL MATTERS
Although the Company does not currently manufacture commercial quantities
of its product candidates, it produces limited quantities of such products for
its clinical trials. The Company's research and development processes involve
the controlled storage, use and disposal of hazardous materials, biological
hazardous materials and radioactive compounds. The Company is subject to
federal, state and local laws and regulations governing the use, manufacture,
storage, handling and disposal of such materials and certain waste products.
Although the Company believes that its safety procedures for handling and
disposing of such materials comply with the standards prescribed by such laws
and regulations, the risk of accidental contamination or injury from these
materials cannot be completely eliminated. In the event of such an accident,
the Company could be held liable for any damages that result, and any such
liability could exceed the resources of the Company. The Company may be
required to incur significant costs to comply with current or future
environmental laws and regulations and the operations, business or assets of the
Company may be materially and adversely affected by current or future
environmental laws or regulations.
SUBORDINATION OF COMMON STOCK TO PREFERRED STOCK
The Company's Common Stock is expressly subordinate to the Company's
Series F Convertible Preferred Stock in the event of the liquidation,
dissolution or winding up of the Company. If the Company were to cease
operations and liquidate its assets, there may not be any remaining value
available for distribution to the holders of Common Stock after providing for
the Series F Convertible Preferred Stock liquidation preference.
VOLATILITY OF STOCK PRICE AND ABSENCE OF DIVIDENDS
The market price of Immune Response's common stock, like that of the common
stock of many other biopharmaceutical companies, has been and is likely to be
highly volatile. Factors such as the results of preclinical studies and
clinical trials by the Company, its collaborators or its competitors, other
evidence of the safety or efficacy of products of the Company or its
competitors, announcements of technological innovations or new products by the
Company or its competitors, governmental regulatory actions, changes or
announcements in reimbursement policies, developments with the Company's
collaborators, developments concerning patent or other proprietary rights of the
Company or its competitors (including litigation), concern as to the safety of
the Company's products, period-to-period fluctuations in the Company's operating
results, changes in estimates of the Company's performance by securities
analysts, market conditions for biopharmaceutical stocks in general and other
factors not within the control of the Company could have a significant adverse
impact on the market price of the common stock. The Company has never paid cash
dividends on its common stock and does not anticipate paying any cash dividends
in the foreseeable future.
EFFECT OF CERTAIN ANTI-TAKEOVER PROVISIONS
The Company's Certificate of Incorporation and Bylaws include provisions
that could discourage potential takeover attempts and make attempts by
stockholders to change management more difficult. The approval of 66 2/3
-11-
<PAGE>
percent of the Company's voting stock is required to approve certain
transactions and to take certain stockholder actions, including the calling of
special meetings of stockholders and the amendment of any of the anti-takeover
provisions contained in the Company's Certificate of Incorporation. Further,
pursuant to the terms of its stockholder rights plan, the Company has
distributed a dividend of one right for each outstanding share of common stock.
These rights will cause substantial dilution to the ownership of a person or
group that attempts to acquire the Company on terms not approved by the Board of
Directors and may have the effect of deterring hostile takeover attempts.
USE OF PROCEEDS
The Company will not receive any proceeds from the sale of the Shares
offered hereby.
INCOME TAX CONSIDERATIONS
Each prospective purchaser should consult his or her own tax advisor with
respect to the income tax issues and consequences of holding and disposing of
the Common Stock.
-12-
<PAGE>
SELLING STOCKHOLDERS
As of June 30, 1998 there were four (4) Selling Stockholders, as set forth
below. Share ownership information is based solely upon either information
furnished to the Company or reports furnished to the Company by the respective
individuals or entities, as the case may be, pursuant to the rules of the
Commission:
<TABLE>
<CAPTION>
Percentage of
Common Stock to be
Shares of Common Held After Sale
Stock Issuable Upon Assuming Full
Conversion of the Conversion of
Series F Convertible Series F Convertible
Preferred Stock Number of Preferred Stock and
Held at Shares Being Sale of
Selling Stockholders May 15, 1998(1) Offered(1) Common Stock
- ----------------------------------- -------------------- ---------------- ----------------
<S> <C> <C> <C>
Themis Partners L.P. . . . . . . . 167,022 167,022 0
Heracles Fund . . . . . . . . . . . 508,173 508,173 0
Brown Simpson Strategic
Growth Fund, Ltd. . . . . . . . . 28,429 28,429 0
Brown Simpson Strategic
Growth Fund, L.P. . . . . . . . . 7,107 7,107 0
</TABLE>
__________
(1) Excludes additional shares of Common Stock which would be issuable to the
Selling Stockholders upon conversion of the Series F Convertible Preferred
Stock if the conversion price is adjusted downward pursuant to the terms of
the Series F Convertible Preferred Stock and excludes shares of Common
Stock which will be issuable to the Selling Stockholders to pay the
dividend of 7.5% per annum payable on the Series F Convertible Preferred
Stock.
There has been no material relationship between the Selling Stockholders
and the Company in the past three years except as a result of ownership of the
Series F Convertible Preferred Stock.
PLAN OF DISTRIBUTION
The Shares are being offered on behalf of the Selling Stockholders, and
the Company will not receive any proceeds from the offering. The Shares may
be sold or distributed from time to time by the Selling Stockholders, or by
pledgees, donees or transferees of, or other successors in interest to, the
Selling Stockholders, directly to one or more purchasers (including pledgees)
or through brokers dealers or underwriters who may act solely as agents or
may acquire Shares as principals, at market prices prevailing at the time of
sale, at prices related to such prevailing market prices, at negotiated
prices, or at fixed prices, which may be changed. The distribution of the
Shares may be effected in one or more of the following methods: (i) ordinary
brokers' transactions, which may include long or short sales; (ii)
transactions involving cross or block trades or otherwise on the Nasdaq
National Market or such other exchange or market on which the Common Stock is
listed for trading; (iii) purchases by brokers, dealers or underwriters as
principal and resale by purchasers for their own accounts pursuant to this
Prospectus; (iv) "at the market" to or through market makers or into an
existing market for the Common Shares; (v) in other ways not involving market
makers or established trading markets, including direct sales to purchasers
or sales effected through agents; (vi) through transactions in options, swaps
or other derivatives (whether exchange-listed or otherwise); or (vii) any
combination of the foregoing, or by any other legally available means. In
addition, the Selling Stockholders or their successors in interest may enter
into hedging transactions with broker-dealers who may engage in short sales
of Shares in the course of hedging the positions they assume with the Selling
Stockholders. The Selling Stockholders or its successors in interest may
also enter into option or other transactions with broker-dealers that require
the delivery by such broker-dealers of the Shares, in which Shares may
-13-
<PAGE>
be resold thereafter pursuant to this Prospectus. The Selling Stockholders
or their successors in interest may also pledge shares as collateral for
margin accounts and such shares could be resold pursuant to the terms of such
accounts.
Brokers, dealers, underwriters or agents participating in the
distribution of the Shares as agents may receive compensation in the form of
commissions, discounts or concessions from the Selling Stockholders and/or
purchasers of the Shares for whom such broker-dealers may act as agent, or to
whom they may sell as principal, or both (which compensation as to a
particular broker-dealer may be less than or in excess of customary
commissions). The Selling Stockholders and any broker-dealers who act in
connection with the sale of Shares hereunder may be deemed to be
"Underwriters" within the meaning of the Securities Act, and any commissions
they receive and proceeds of any sale of Shares may be deemed to be
underwriting discounts and commission under the Securities Act. Neither the
Company nor the Selling Stockholders can presently estimate the amount of
such compensation. The Company knows of no existing arrangement between the
Selling Stockholders, any other stockholder, broker, dealer, underwriter or
agent relating to the sale or distribution of the Shares.
The Shares may not be sold by the Selling Stockholders. To the extent
required, (i) the Shares to be sold hereby, (ii) the name of the Selling
Stockholders, (iii) the purchase price, (iv) the name of any such agent,
dealer or underwriter, (v) any applicable commissions, discounts or other
terms constituting compensation with respect to a particular offer, (vi)
disclosure that such broker or dealer did not conduct any investigation to
verify information set out or incorporated by reference in this Prospectus
and (vii) other facts material to the transaction will be set forth in an
accompanying Prospectus Supplement.
All expenses (estimated to be $60,000) of the registration of the Common
Stock covered by this Prospectus will be borne by the Company pursuant to
preexisting agreements, except that the Company will not pay any Selling
Stockholder's underwriting discounts or selling commissions.
The Company has agreed to indemnify the Selling Stockholders against
certain liabilities in connection with this registration, including
liabilities under the Securities Act.
In order to comply with certain states securities laws, if applicable,
the Common Stock will not be sold in a particular state unless such
securities have been registered or qualified for sale in such state or any
exemption from registration or qualification is available and complied with.
LEGAL MATTERS
Certain legal matters with respect to the validity of the Shares offered
hereby are being passed upon for the Company by Pillsbury Madison & Sutro LLP,
San Francisco, California. A partner of Pillsbury Madison & Sutro LLP owns
15,000 shares of Common Stock and an option to acquire 20,000 shares of Common
Stock.
EXPERTS
The consolidated financial statements of Immune Response appearing in
Immune Response's Annual Report (Form 10-K) for the year ended December 31,
1997 have been audited by Arthur Andersen LLP, independent auditors, as set
forth in their report thereon included therein and incorporated herein by
reference. Such consolidated financial statements are incorporated herein by
reference in reliance upon the authority of such firms as experts in
accounting and auditing.
-14-
<PAGE>
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
No dealer, salesperson or any other person has been authorized to give any
information or to make any representation not contained in this Prospectus in
connection with the offer made by this Prospectus and, if given or made, such
information or representation must not be relied upon as having been authorized
by the Company or the Selling Stockholders. This Prospectus does not constitute
an offer to sell or a solicitation of an offer to buy any securities other than
the registered securities to which it relates, or an offer in any jurisdiction
to any person to whom it is unlawful to make such an offer in such jurisdiction.
Neither the delivery of this Prospectus nor any sale made hereunder shall, under
any circumstances, create any implication that the information contained herein
is correct at any time subsequent to the date hereof.
------------------------
TABLE OF CONTENTS
<TABLE>
<CAPTION>
Page
-----
<S> <C>
Available Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Documents Incorporated by Reference. . . . . . . . . . . . . . . . . . . . . . 3
Special Note Regarding Forward-looking
Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
The Company. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Use of Proceeds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Income Tax Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . .12
Selling Stockholders . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Plan of Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Legal Matters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Experts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
</TABLE>
1,700,000 Shares
Common Stock
THE IMMUNE
RESPONSE CORPORATION
----------------------------
PROSPECTUS
----------------------------
July __, 1998
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the various expenses in connection with the
sale and distribution of the securities being registered hereby, other than
underwriting discounts and commissions. All amounts are estimated except the
Securities and Exchange Commission registration fee and the Nasdaq National
Market listing fee.
<TABLE>
<CAPTION>
Amount
----------
<S> <C>
SEC registration fee....................... $ 5,705
Blue Sky fees and expenses................. 1,000
Accounting fees and expenses............... 5,000
Legal fees and expenses.................... 20,000
Registrar and transfer agent's fees........ 1,000
NNM listing fee............................ 17,500
Miscellaneous fees and expenses............ 9,795
---------
Total $ 60,000
---------
---------
</TABLE>
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 145 of the Delaware General Corporation Law (the "Delaware GCL")
permits the Company's board of directors to indemnify any person against
expenses (including attorneys' fees), judgments, fines and amounts paid in
settlement actually and reasonably incurred by him in connection with any
threatened, pending or completed action, suit or proceeding in which such
person is made a party by reason of his being or having been a director,
officer, employee or agent of the Company, in terms sufficiently broad to
permit such indemnification under certain circumstances for liabilities
(including reimbursement for expenses incurred) arising under the Securities
Act of 1933, as amended (the "Act"). The Delaware GCL provides that
indemnification pursuant to its provisions is not exclusive of other rights
of indemnification to which a person may be entitled under any by-law,
agreement, vote of stockholders or disinterested directors, or otherwise.
Article VII of the Company's Restated Certificate of Incorporation, as
amended, and Article V of the Company's Bylaws, provide for indemnification
of the Company's directors, officers, employees and other agents to the
maximum extent permitted by law.
In addition, the Company has entered into separate indemnification
agreements with its directors and officers that will require the Company,
among other things, to indemnify them against certain liabilities that may
arise by reason of their status or service as directors or officers to the
fullest extent not prohibited by law.
II-1
<PAGE>
ITEM 16. EXHIBITS
<TABLE>
<CAPTION>
Exhibit
Number Description of Document*
- ------- --------------------------------------
<S> <C>
5.1(1) Opinion of Pillsbury Madison & Sutro LLP
regarding the legality of the securities being
registered.
10.1(2) Securities Purchase Agreement dated as of
April 24, 1998 by and among the Company and the
Selling Stockholders.
10.2(2) Registration Rights Agreement dated as of
April 24, 1998 by and among the Company and the
Selling Stockholders.
23.1 Consent of independent public accountants.
23.2 Consent of Pillsbury Madison & Sutro LLP
(included in its opinion filed as Exhibit 5.1 to
this Registration Statement).
24.1(1) Power of Attorney.
</TABLE>
__________
* Parenthetical references after description of exhibits relate to the
exhibit number under which exhibits were initially filed.
(1) Previously filed.
(2) Incorporated by reference to the exhibits of the same number to the
Company's Report on Form 8-K dated April 24, 1998 (Commission File
No. 0-18006).
ITEM 17. UNDERTAKINGS
Insofar as indemnification for liabilities arising under the Securities
Act of 1933, as amended (the "Act"), may be permitted to directors, officers
and controlling persons of the Company pursuant to the foregoing provisions,
or otherwise, the Company 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 Company of expenses incurred or paid by a director, officer or
controlling person of the Company 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 Company 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.
The undersigned Company 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 Act; (ii) to
reflect in the prospectus any facts or events arising after the effective
date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a
fundamental change in the information set forth in this Registration
Statement; and (iii) to include any material information with respect to
the plan of distribution not previously disclosed in this Registration
Statement or any material change to such information in this Registration
Statement; provided, however, that paragraphs (i) and (ii) do not apply if
the information required to be included in
II-2
<PAGE>
a post-effective amendment by those paragraphs is contained in periodic
reports filed by the Registrant pursuant to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934, as amended (the "Exchange Act")
that are incorporated by reference in this Registration Statement.
(2) That, for the purpose of determining any liability under the
Act, each post-effective amendment that contains a form of prospectus
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.
(4) For purposes of determining any liability under the Act, each
filing of the Registrant's annual report pursuant to Section 13(a) or
Section 15(d) of the Exchange Act which is incorporated by reference in
this 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.
II-3
<PAGE>
SIGNATURES
----------
Pursuant to the requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-3, and has duly caused this Amendment to
Registration Statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in the City of Carlsbad, State of California, July 8, 1998.
THE IMMUNE RESPONSE CORPORATION
By /s/ Charles J. Cashion
------------------------------------------
Charles J. Cashion, Senior Vice President,
Finance and Administration, Chief
Financial Officer, Secretary and Treasurer
POWER OF ATTORNEY
Pursuant to the requirements of the Securities Act of 1933, this Amendment
to 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>
* President, Chief Executive Officer and July 8, 1998
---------------------- Director (Principal Executive Officer)
Dennis J. Carlo, Ph.D.
/s/ Charles J. Cashion Senior Vice President, Finance and July 8, 1998
---------------------- Administration, Chief Financial
Charles J. Cashion Officer, Secretary and Treasurer
(Principal Financial and Principal
Accounting Officer)
</TABLE>
II-4
<PAGE>
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
* Chairman of the Board July 8, 1998
----------------------
James B. Glavin
---------------------- Director July __, 1998
Kevin B. Kimberlin
---------------------- Director July __, 1998
Melvin Perelman
* Director July 8, 1998
----------------------
John Simon
* Director July 8, 1998
----------------------
William M. Sullivan
* Director July 8, 1998
----------------------
Philip M. Young
*By /s/ Charles J. Cashion
- --------------------------
Charles J. Cashion
Attorney-in-Fact
</TABLE>
II-5
<PAGE>
EXHIBIT INDEX
-------------
<TABLE>
<CAPTION>
Exhibit
Number Description of Document*
- ------- ----------------------------------------------------------
<S> <C>
5.1(1) Opinion of Pillsbury Madison & Sutro LLP regarding the
legality of the securities being registered.
10.1(2) Securities Purchase Agreement dated as of April 24, 1998 by
and among the Company and the Selling Stockholders.
10.2(2) Registration Rights Agreement dated as of April 24, 1998 by
and among the Company and the Selling Stockholders.
23.1 Consent of independent public accountants.
23.2 Consent of Pillsbury Madison & Sutro LLP (included in its
opinion filed as Exhibit 5.1 to this Registration Statement).
24.1(1) Power of Attorney.
</TABLE>
__________
(2) Incorporated by reference to the exhibits of the same number to the
Company's Report on Form 8-K dated April 24, 1998 (Commission File
No. 0-18006).
<PAGE>
EXHIBIT 23.1
CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS
As independent public accountants, we hereby consent to the incorporation
by reference in this registration statement of our report dated January 19, 1998
included in The Immune Response Corporation's Form 10-K for the year ended
December 31, 1997 and to all references to our Firm included in this
registration statement.
San Diego, California
July 7, 1998
