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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON MAY 30, 2000
REGISTRATION NO. 333-
================================================================================
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
VALENTIS, INC.
(Exact name of Registrant as specified in its charter)
DELAWARE 94-3156660
(State or other jurisdiction of (I.R.S. Employer Identification Number)
incorporation or organization)
863A MITTEN ROAD
BURLINGAME, CA 94010
(650) 697-1900
(Address, including zip code, and telephone number, including
area code, of Registrant's principal executive offices)
BENJAMIN F. MCGRAW, III
PRESIDENT AND CHIEF EXECUTIVE OFFICER
VALENTIS, INC.
863A MITTEN ROAD
BURLINGAME, CA 94010
(650) 697-1900
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Copies to:
ALAN C. MENDELSON, ESQ.
LATHAM & WATKINS
135 COMMONWEALTH DRIVE
MENLO PARK, CA 94025
(650) 328-4600
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
From time to time after this Registration Statement becomes effective.
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 in connection with dividend or interest
reinvestment plans, check the following box. /X/
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. / /
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. / /
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. / /
<TABLE>
<CAPTION>
CALCULATION OF REGISTRATION FEE
------------------------------------- -------------- ---------------------------- ------------------------------- ------------------
AMOUNT TO BE PROPOSED MAXIMUM OFFERING PROPOSED MAXIMUM AGGREGATE AMOUNT OF
TITLE OF SECURITIES TO BE REGISTERED REGISTERED PRICE PER SHARE (1) OFFERING PRICE (1) REGISTRATION FEE
------------------------------------- -------------- ---------------------------- ------------------------------- ------------------
<S> <C> <C> <C> <C>
Common Stock, $.001 par value.... 1,915,000 $7.40625 $14,182,968.75 $3,744.30
------------------------------------- -------------- ---------------------------- ------------------------------- ------------------
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(1) Estimated solely for the purpose of calculating the amount of the
registration fee pursuant to Rule 457(c) of the Securities Act of 1933. The
price per share and aggregate offering price are based upon the average of
the high and low sales price of Valentis' common stock on May 26, 2000 as
reported on the Nasdaq National Market. It is not known how many shares
will be purchased under this registration statement or at what price such
shares will be purchased.
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.
<PAGE>
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. THE
SELLING STOCKHOLDERS MAY NOT SELL THESE SECURITIES UNTIL THE REGISTRATION
STATEMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE.
THIS PROSPECTUS IS NOT AN OFFER TO SELL THESE SECURITIES AND IT IS NOT
SOLICITING AN OFFER TO BUY THESE SECURITIES IN ANY STATE WHERE THE OFFER OR
SALE IS NOT PERMITTED.
SUBJECT TO COMPLETION, DATED MAY 30, 2000
PROSPECTUS
1,915,000 SHARES
VALENTIS, INC.
COMMON STOCK
We are registering 1,915,000 shares of our common stock for resale by
the selling stockholders identified in this prospectus. We will not receive any
of the proceeds from the sale of shares by the selling stockholders. Our common
stock is listed on the Nasdaq National Market under the symbol "VLTS." The
closing sale price of our common stock, as reported on the Nasdaq National
Market on May 26, 2000, was $7.4375 per share.
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. SEE "RISK
FACTORS," BEGINNING ON PAGE 4.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS
PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
The date of this prospectus is ________, 2000.
<PAGE>
THIS PROSPECTUS IS PART OF A LARGER REGISTRATION STATEMENT WE FILED WITH THE
SEC. YOU SHOULD RELY ON THE INFORMATION INCORPORATED BY REFERENCE OR PROVIDED IN
THIS PROSPECTUS. WE HAVE NOT AUTHORIZED ANYONE ELSE TO PROVIDE YOU WITH
DIFFERENT INFORMATION. WE ARE NOT MAKING AN OFFER OF THESE SECURITIES IN ANY
STATE WHERE THE OFFER IS NOT PERMITTED. YOU SHOULD NOT ASSUME THAT THE
INFORMATION IN THIS PROSPECTUS IS ACCURATE AS OF ANY DATE OTHER THAN THE DATE ON
THE FRONT OF THE DOCUMENT.
WHERE YOU CAN GET MORE INFORMATION
We are a reporting company and file annual, quarterly and current
reports, proxy statements and other information with the SEC. You may read and
copy these reports, proxy statements and other information at the SEC's public
reference rooms in Washington, D.C., New York, NY and Chicago, IL. You can
request copies of these documents by writing to the SEC and paying a fee for the
copying cost. Please call the SEC at 1-800-SEC-0330 for more information about
the operation of the public reference rooms. Our SEC filings are also available
at the SEC's Web site at "http://www.sec.gov."
The SEC allows us to "incorporate by reference" information that we
file with them, which means that we can disclose important information to you by
referring you to those documents. The information incorporated by reference is
an important part of this prospectus, and information that we file later with
the SEC will automatically update and supersede this information. We incorporate
by reference the documents listed below and any future filings we will make with
the SEC under Section 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act
of 1934:
- Annual Report on Form 10-K for the year ended June 30, 1999;
- Quarterly Reports on Form 10-Q for the quarters ended September
30, 1999, December 31, 1999 and March 31, 2000;
- Proxy Statement for the annual meeting of stockholders held on
December 7, 1999;
- Current Reports on Form 8-K filed on November 9, 1999, February
4, 2000 and April 18, 2000; and
- Registration statement on Form 8-A, as amended, which includes a
description of our common stock.
You may request a copy of these filings at no cost, by writing or
telephoning us at the following address or telephone number:
Valentis, Inc.
863 Mitten Road
Burlingame, CA 94010
(650) 697-1900.
2.
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VALENTIS, INC.
Valentis, Inc. develops proprietary technologies and applies its
preclinical and early clinical development expertise to create novel
therapeutics. Our core technologies include multiple gene delivery and gene
expression systems and PEGylation technologies designed to improve the
safety, efficacy and dosing characteristics of genes, proteins, peptides,
peptidomimetics (peptide-like small molecules), antibodies and replicating
and non-replicating viruses. These technologies are covered by a broad patent
portfolio that includes issued U.S. and European claims. Our commercial
strategy is to enter into corporate collaborations for full-scale clinical
development and marketing and sales of products. We currently have corporate
collaborations with:
- Roche Holdings Ltd. ("Roche") for cancer immunotherapeutics;
- Eli Lilly & Co. ("Lilly") to develop treatments for breast and
ovarian cancer using the BRCA1 gene;
- Glaxo Wellcome plc ("Glaxo Wellcome") to develop a treatment for
cystic fibrosis using the CFTR gene;
- Heska Corporation ("Heska") for animal health;
- Transkaryotic Therapies Inc. for PEGylation of certain proteins;
- Onyx Pharmaceuticals Inc. for a PEGylated virus-based cancer
therapeutic;
- Bayer Corporation for a PEGylated Factor VIII; and
- DSM Biologics and Qiagen N.V. for plasmid manufacturing.
With the acquisition of London-based PolyMASC Pharmaceuticals plc
("PolyMASC"), in August 1999, we expanded our delivery technologies and have a
more diversified portfolio of products in clinical and preclinical development.
The acquisition broadened our intellectual property portfolio in biologics
delivery, creating what is believed to be the first company offering a broad
array of technologies and intellectual property in biologics delivery. This
resulted in the issuance of approximately 4.2 million additional shares of our
common stock, valued at $19.8 million.
We now have a full range of delivery systems for biologic products,
including genes, proteins, peptides, peptidomimetics, antibodies and
replicating and non-replicating viruses. This expanded portfolio of delivery
technologies allows us to maintain our focus on creating improved versions of
currently marketed products as well as solving safety, efficacy and
compliance issues with proteins and antibodies in development. Our
technologies include clearly differentiated delivery systems for replicating
and non-replicating viruses.
PolyMASC, our wholly owned subsidiary, will continue to operate in its
London location and focus primarily on research and preclinical development of
PEGylation technologies and products.
Our executive offices are located at 863A Mitten Road, Burlingame, CA
94010, and our telephone number is (650) 697-1900.
All references to "PolyMASC" are to our wholly owned subsidiary,
PolyMASC Pharmaceuticals, plc. All references to "we," "us" or "our company" are
to Valentis, Inc.
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RISK FACTORS
DEVLOPMENT OF OUR PRODUCTS WILL TAKE SEVERAL MORE YEARS AND WILL REQUIRE
REGULATORY APPROVAL BEFORE THEY CAN BE SOLD
Because substantially all of our potential products currently are in
research, preclinical development, or the early stages of clinical testing,
revenues from sales of any products will not occur for at least the next several
years, if at all. We cannot be certain that any of our products will be safe and
effective or that we will obtain regulatory approvals. In addition, any products
that we develop may not be economical to manufacture on a commercial scale. Even
if we develop a product that becomes available for commercial sale, we cannot be
certain that consumers will accept the product.
If we cannot satisfy existing clinical and regulatory approval
requirements, we or one of our partners may not be able to market our products.
We may not obtain regulatory approval for the commercial sale of any of our
products, or be able to demonstrate that a potential product is safe and
effective for its intended use. We cannot be certain that we or our corporate
partners will be permitted to undertake clinical testing of our potential
products and, if we are successful in initiating clinical trials, we may
experience delays in conducting them.
While we have demonstrated some evidence that our gene delivery systems
have utility in preclinical studies, these results do not mean that the
resulting products will be safe and effective in humans. Our gene delivery
systems may have undesirable and unintended side effects or other
characteristics that may prevent or limit their use.
Gene-based therapies and enhanced delivery of pharmaceuticals based on
biologics are new and rapidly evolving technologies that are expected to undergo
significant technological changes in the future. Many other companies are
seeking to identify therapeutic genes and understand their function in the
development and progression of various diseases. However, only limited clinical
data are available regarding the safety and efficacy of gene-based therapeutics.
We are not aware of any gene-based therapeutic that has received marketing
approval from the United States Food and Drug Administration, or FDA, or foreign
regulatory authorities. As a result, clinical trials relating to gene-based
therapeutics may take longer to complete than clinical trials involving more
traditional pharmaceuticals.
We do not yet have products in the commercial markets. All of our
potential products are in preclinical development or in the early stages of
clinical testing. We cannot apply for regulatory approval of our potential
products until we have performed additional research and development and
testing. Our clinical trials may not demonstrate the safety and efficacy of our
potential products, and we may encounter unacceptable side effects or other
problems in the clinical trials. Should this occur, we may have to delay or
discontinue development of the potential product that causes the problem. After
a successful clinical trial, we cannot market products in the United States
until we receive regulatory approval. If we are able to gain regulatory approval
of our products after successful clinical trials and then commercialize and sell
those products, we may be unable to manufacture enough products to maintain our
business or secure additional financing to fund our operations.
WE HAVE A HISTORY OF LOSSES AND MAY NEVER BE PROFITABLE
We may never generate profits, and if we do become profitable, we may
be unable to sustain or increase profitability on a quarterly or annual basis.
As a result, the trading price of our stock could decline and you could lose all
or part of your investment.
Since our inception, we have engaged in research and development
activities. We have generated only small amounts of revenue and have
experienced significant operating losses since we began business. As of March
31, 2000, we have incurred losses from inception totaling $110.4 million. The
process of developing our products will require significant additional
research and development, preclinical testing, clinical trials and regulatory
approvals. These activities, together with general and administrative
expenses, are expected to result in operating losses for the foreseeable
future.
WE MUST BE ABLE TO CONTINUE TO SECURE ADDITIONAL FINANCING
Developing and commercializing our potential products will require
substantial additional financial resources. Because we cannot expect internally
generated cash flow to fund development and commercialization of our products,
we will look to outside sources for funding. These sources could involve one or
more of the following types of transactions:
- technology partnerships;
- technology sales;
- technology licenses;
- issuing debt; or
- sales of common or preferred stock.
4.
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Our future capital requirements will depend on many factors, including:
- scientific progress in its research and development programs;
- size and complexity of such programs;
- scope and results of preclinical studies and clinical trials;
- ability to establish and maintain corporate collaborations;
- time and costs involved in obtaining regulatory approvals;
- time and costs involved in filing, prosecuting and enforcing
patent claims;
- competing technological and market developments; and
- the cost of manufacturing material for preclinical, clinical and
commercial purposes.
We have financed our operations primarily through the sale of equity
securities and through corporate collaborations. We have not generated
significant royalty revenues from product sales, and we do not expect to receive
significant revenue from royalties for the foreseeable future, if ever. We
expect that our existing resources will enable us to maintain our operations
through at least the calendar year ending December 31, 2001. However, we may
require additional funding prior to such time.
We cannot be certain that additional financing to meet our funding
requirements will be available. Even if financing is available, the terms may
not be attractive. If we cannot obtain additional financing when needed or on
acceptable terms, we will be unable to fund continuing operations. In addition,
if we raise additional funds by issuing equity securities, our shareholders will
likely experience significant dilution of their ownership interest.
THERE IS INTENSE COMPETITION IN THE BIOLOGICS-BASED THERAPEUTICS MARKET
The pharmaceutical and biotechnology industries are highly competitive.
The intense competition and rapid technological change in our market may result
in pricing pressures and failure of our products to achieve market acceptance.
We are aware of several pharmaceutical and biotechnology companies
that are pursuing gene-based therapeutics or are incorporating PEGylated
technologies into new pharmaceuticals. Many of these companies are addressing
diseases that have been targeted by our corporate collaborators and us. We
are also aware that some of our corporate collaborators are developing
gene-based and PEGylated therapeutics with one or more of our competitors. We
also face competition from companies developing cell-based therapies and from
companies using more traditional approaches to treating human diseases. Most
of our competitors have substantially more experience and financial and
infrastructure resources than we do in the following areas:
- research and development;
- clinical trials;
- obtaining Food and Drug Administration and other regulatory
approvals; and
- manufacturing, marketing and distribution.
As competitors develop their technologies, they may develop proprietary
positions in a particular aspect of biologics delivery that could prevent us
from developing our products. Consequently, our competitors may be able to
commercialize new products more rapidly than we do, or manufacture and market
competitive products more successfully than we do. This could result in pricing
pressures or the failure of our products to achieve market acceptance.
Gene therapy and enhanced delivery of biologics are new and rapidly
evolving fields and are expected to continue to undergo significant and rapid
technological change. Rapid technological development by our competitors could
result in our actual and proposed technologies, products or processes losing
market share or becoming obsolete.
In addition, we face intense competition from other companies for
corporate collaborations, for establishing relationships with academic and
research institutions and for licenses to proprietary technology. Our
competitors may develop safer, more effective or less costly biologic delivery
systems, gene-based therapeutics or chemical-based therapies. In addition,
competitors may achieve superior patent protection or obtain regulatory approval
or product commercialization earlier than we can.
WE MUST ATTRACT AND RETAIN CORPORATE COLLABORATORS
Our business strategy is to attract business collaborators to fund
or conduct research and development, preclinical studies, clinical trials,
manufacturing, marketing and sales of our products. While we believe that our
collaborators will be motivated to develop, market and distribute potential
products based on our technologies, they may not commit sufficient resources
to commercializing our products on a timely basis. They may also pursue the
development or marketing of competing products. If our business collaborators
do not successfully market and distribute our products and we are unable to
develop sufficient marketing and distribution capabilities on our own, our
business will fail.
5.
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WE MUST ATTRACT AND RETAIN QUALIFIED EMPLOYEES AND CONSULTANTS
Our success will depend on our ability to retain our executive officers
and scientific staff to develop our potential products and formulate our
research and development strategy. We have programs in place to retain
personnel, including programs to create a positive work environment and
competitive compensation packages. Because competition for employees in our
field is intense, however, we may be unable to retain our existing personnel or
attract additional qualified employees. Our success also depends on the
continued availability of outside scientific collaborators to perform research
and develop processes to advance and augment our internal research efforts.
Competition for collaborators is intense. If we do not attract and retain
qualified personnel and scientific collaborators, and if we experience turnover
or difficulties recruiting new employees, our research and development programs
could be delayed and we could experience difficulties in generating sufficient
revenue to maintain our business.
WE MUST OBTAIN RIGHTS TO PROPRIETARY GENES, PROTEINS OR OTHER TECHNOLOGIES
We, and our corporate partners, are investigating the use of gene
sequences and proteins in our products. A number of these gene sequences and
proteins have been, or may be, patented by others. As a result, we may be
required to obtain licenses to those gene sequences, proteins or other
technologies. In addition, some of the products based on our gene or PEGylation
delivery systems will require the use of multiple proprietary technologies. We
may not be able to obtain a license to those technologies at reasonable terms,
if at all. As a consequence, we might be prohibited from developing potential
products or we might have to make cumulative royalty payments to several
companies. These cumulative royalties would reduce amounts paid to us and could
be make the costs of our products too expensive to introduce.
WE MAY BE UNABLE TO PROTECT OUR PATENTS AND PROPRIETARY RIGHTS
We may be unable to adequately protect our proprietary rights, which
may limit our ability to compete effectively. Our success will depend to a
significant degree on our ability to:
- obtain patents and licenses to patent rights;
- preserve trade secrets; and
- operate without infringing on the proprietary rights of others.
We own or have licenses to patents on a number of genes, processes,
practices and techniques critical to our present and potential products. If we
fail to obtain and maintain patent protection for our technologies, our
competitors may market competing products that threaten our market position. The
failure of our licensors to obtain and maintain patent protection for technology
they license to us could similarly harm our business. Patent positions in the
field of biotechnology are highly uncertain and involve complex legal,
scientific and factual questions. Our patent applications may not result in
issued patents. Even if we secure a patent, the patent may not afford adequate
protection against our competitors. Intellectual property claims and litigation
could subject us to significant liability for damages and invalidation of our
patent rights.
We also rely on unpatented trade secret technologies. Because these
technologies do not benefit from the protection of patents, we may be unable to
meaningfully protect these trade secret technologies from unauthorized use or
misappropriation by a third party.
As the biotechnology industry expands, the risks increase that other
companies may claim that our processes and potential products infringe on their
patents. Defending these claims would be costly and would likely divert
management's attention and resources away from our operations. If we infringe on
another company's patented processes or technology, we may have to pay damages
or obtain a license in order to continue manufacturing or marketing the affected
product or using the affected process. We may be unable to obtain a license on
acceptable terms.
OUR PRODUCTS MUST SATISFY GOVERNMENT REGULATIONS
We may not receive approval from regulatory authorities to market any
of our products. Also, delays or unexpected costs in obtaining approval of our
products or complying with governmental regulatory requirements could decrease
our ability to sell products, generate revenue and would make funding our
operations more difficult.
Prior to marketing any drug or biological product in the U.S., a
potential product must undergo rigorous preclinical studies and clinical trials.
In addition, the product must receive regulatory approval from the FDA.
Satisfaction of the FDA requirements typically takes several years or more and
costs a substantial amount of money. We cannot be certain that we will obtain
regulatory approval even if we devote substantial resources and time. The
regulatory process in the biologics delivery industry is costly, time-consuming
and subject to unpredictable delays. Accordingly, we cannot predict with any
certainty how long it will take or how much it will cost to obtain regulatory
approvals for clinical trials or for manufacturing or marketing our potential
products. Delays in bringing a potential product to market or unexpected costs
in obtaining regulatory approvals could decrease our ability to generate revenue
and make it more difficult to obtain additional financing necessary to fund our
operations.
6.
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In addition, drug manufacturing facilities in the U.S. must comply with
the FDA's good manufacturing process regulations. Such facilities are subject to
periodic inspection by the FDA and state authorities. Manufacturers of biologics
also must comply with the FDA's general biological product standards and also
may be subject to state regulation. While we anticipate that we will be able to
manufacture product that meets these requirements, we may be unable to attain or
maintain compliance with current or future Good Manufacturing Practices
requirements. If we discover previously unknown problems after we receive
regulatory approval of a potential product or fail to comply with applicable
regulatory requirements, we may suffer restrictions on our ability to market the
product, including mandatory withdrawal of the product from the market. This, or
an unexpected increase in the cost of compliance, could decrease our ability to
generate revenue or become profitable.
WE MUST OBTAIN FOREIGN REGULATORY APPROVALS TO MAKE AND SELL PRODUCTS IN FOREIGN
COUNTRIES
We cannot be certain that we will obtain regulatory approvals in other
countries. In order to market our products outside the US, we, and our corporate
partners, must comply with numerous and varying regulatory requirements of other
countries regarding safety and quality. The approval procedures vary among
countries and can involve additional testing. The time required obtaining
approval in other countries might differ from that required obtaining FDA
approval. The regulatory approval process in other countries involves similar
risks to those associated with obtaining FDA approval set forth above. Approval
by the FDA does not ensure approval by the regulatory authorities of any other
country.
OUR PRODUCTS MUST BE ACCEPTED BY PHYSICIANS AND INSURERS
Concerns have arisen regarding the potential safety and efficacy of
gene-based therapeutics using viral delivery systems. While our gene delivery
systems do not contain viruses, these concerns could negatively affect
physicians' and health care payers' evaluations of our products. Physicians and
health care payers could conclude that our products or technologies are not safe
and effective. Our success is dependent on commercial acceptance of our
products. We believe that recommendations by physicians and health care payers
will be essential for commercial acceptance of our products. If products
developed the Company and our corporate partners are not commercially accepted
by patients, physicians or third-party payers, sales would be adversely
affected.
ADVERSE EVENTS IN THE FIELD OF GENE THERAPY MAY NEGATIVELY IMPACT REGULATORY
APPROVAL OR PUBLIC PERCEPTION OF OUR POTENTIAL PRODUCTS
The recent death of a patient undergoing a viral-based gene therapy has
been widely publicized. This death and other adverse events in the field of gene
therapy that may occur in the future could result in greater governmental
regulation of our potential products and potential regulatory delays relating to
the testing or approval of our potential products. For example, as a result of
this death, the Recombinant DNA Advisory Committee of the National Institutes of
Health may become more active in reviewing the clinical trials or proposed
clinical trials of all companies involved in gene therapy. It is uncertain what
effect this increased scrutiny will have on our product development efforts or
clinical trials.
The commercial success of our potential products will depend in part on
public acceptance of the use of gene therapy for the prevention or treatment of
human diseases. Public attitudes may be influenced by claims that gene therapy
is unsafe, and consequently our products may not gain the acceptance of the
public or the medical community. Negative public reaction to gene therapy in
general could result in greater government regulation and stricter labeling
requirements of gene therapy products, including any of our products, and could
cause a decrease in the demand for products we may develop.
OUR PRODUCTS MUST OBTAIN ADEQUATE REIMBURSEMENT
Even if we and our corporate partners succeed in bringing products to
market, we cannot be certain that reimbursement will be available. Sales volume
and price of any of our potential products will depend, in part, on the
availability of third-party reimbursement for the cost of such products and
related treatments. Reimbursement is generally provided by government health
administration authorities, private health insurers and other organizations.
Third-party payers are increasingly challenging the price of medical products
and services. Significant uncertainty exists as to the reimbursement status of
newly approved health care products. Even if reimbursement is available, payers'
reimbursement policies may adversely affect our corporate partners' ability to
sell such products on a profitable basis. If these corporate partners are unable
to profitably sell our products, our royalty revenue will be reduced.
THE SUCCESS OF OUR POTENTIAL PRODUCTS IN ANIMAL MODELS DOES NOT GUARANTEE THAT
THESE RESULTS WILL BE REPLICATED IN HUMANS
Even though our product candidates have shown successful results in
animal models, animals are different than humans and these results may not be
replicated in our clinical trials with humans. In addition, human clinical
results could be different from our expectations following our preclinical
studies with large animals. Consequently, you should not rely on the results in
our animal models as being predictive of the results that we will see in our
clinical trials with humans.
7.
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WE HAVE LIMITED EXPERIENCE IN CONDUCTING CLINICAL TRIALS, WHICH MAY CAUSE DELAYS
IN RECEIVING REGULATORY APPROVAL OF OUR POTENTIAL PRODUCTS
Clinical trials must meet FDA regulatory requirements. We have limited
experience in conducting the preclinical studies and clinical trials necessary
to obtain FDA regulatory approval. Consequently, we may encounter problems in
clinical trials that may cause us, or the FDA, to delay, suspend or terminate
these trials. Problems we may encounter include the chance that we may not be
able to conduct clinical trials at preferred sites, obtain sufficient test
subjects or begin or successfully complete clinical trials in a timely fashion,
if at all. Furthermore, the FDA may suspend clinical trials at any time if it
believes the subjects participating in trials are being exposed to unacceptable
health risks or if it finds deficiencies in the clinical trial process or
conduct of the investigation.
Failure to recruit patients could delay or prevent clinical trials of
our potential products, which could cause a delay or inability to introduce
products to market and a resulting decrease in our ability to generate revenue.
The timing of our clinical trials depends on the speed at which we can recruit
patients to participate in testing our products. Delays in recruiting or
enrolling patients to test our products could result in increased costs, delays
in advancing our product development, delays in proving the usefulness of our
technology or termination of the clinical trials altogether. If we are unable to
introduce potential products to market after successful clinical trials on a
timely basis, our ability to generate revenue may decrease and we may be unable
to secure additional financing.
THE RESULTS OF OUR EARLY CLINICAL TRIALS ARE BASED ON A SMALL NUMBER OF PATIENTS
OVER A SHORT PERIOD OF TIME, AND OUR SUCCESS MAY NOT BE INDICATIVE OF RESULTS IN
A LARGE NUMBER OF PATIENTS OR HAVE LASTING EFFECTS
Results in early phases of clinical testing are based upon limited
numbers of patients. Actual results with more data points may show less
favorable results. In addition, we do not yet know if these early results will
have a lasting effect. If a larger population of patients does not experience
similar results, or if these results do not have a lasting effect, our product
candidates may not receive approval from the FDA. In addition, any report of
clinical trial results that are below the expectations of financial analysts or
investors would most likely cause our stock price to drop dramatically.
WE MUST DEMONSTRATE LARGE SCALE MANUFACTURING CAPABILITIES
Our limited manufacturing experience may compromise our ability to
successfully introduce our potential products.
Although we entered into a strategic collaboration with DSM Biologics
and Qiagen N.V. for manufacturing and supplying plasmid DNA to the gene therapy
industry, neither DSM nor any third party has successfully manufactured plasmid
DNA on a large-scale commercial basis. The collaboration has the potential to
create the first manufacturing facilities that can produce high-quality,
ultra-pure material for plasmid-based therapeutics on every scale, from
preclinical toxicology studies to commercial products. DSM will have full
responsibility for manufacturing material to be marketed to any company or
institution working in the field of gene therapy. We will depend on DSM for
commercial-scale manufacturing of our products. DSM may be unable to develop
adequate manufacturing capabilities for commercial-scale quantities of
gene-based therapeutic products. If DSM or third parties are unable to establish
and maintain large-scale manufacturing capabilities, we will be unable to
introduce sufficient product to sustain our business.
DELAWARE LAW AND OUR CHARTER COULD MAKE THE ACQUISITION OF OUR COMPANY BY
ANOTHER COMPANY MORE DIFFICULT
We are incorporated in the State of Delaware. Provisions of Delaware
law applicable to our company could delay a merger, tender offer or proxy
contest or make such a transaction more difficult. State laws prohibit a
Delaware corporation from engaging in any business combination with any
interested stockholder for a period of three years from the date the person
became an interested stockholder unless a number of conditions are met. In
addition, our Board of Directors may issue shares of preferred stock without
Valentis stockholder approval. The rights of our common stockholders may be
decreased by the rights of the any future preferred stockholders. In addition,
we have:
- classified board of directors;
- no right of stockholders to act by written consent without a
meeting;
- advance stockholder notice required to nominate directors and
raise matters at the annual stockholders meeting;
- no cumulative voting in the election of directors; and
- removal of directors only for cause and with a two-thirds vote of
the issued Valentis Common Stock.
These provisions could delay, defer or prevent a change in control of
our company or limit the price that investors might be willing to pay in the
future for shares of our Common Stock.
8.
<PAGE>
OUR INSURANCE MAY NOT BE ADEQUATE
The costs of product liability claims and product recalls could exceed
the amount of our insurance, which could significantly harm our results of
operations or our reputation and result in a decline in the value of our stock.
Our business activities expose us to the risk of liability claims or
product recalls and any adverse publicity that might result from a liability
claim against us. We currently have only limited amounts of product liability
insurance, and the amounts of claims against us may exceed our insurance
coverage. Product liability insurance is expensive and may not continue to be
available on acceptable terms. A product liability claim not covered by
insurance or in excess of our insurance or a product recall could significantly
harm our financial results or our reputation. Either of these could result in a
decrease in our stock price, and you could lose all or part of your investment.
THERE ARE RISKS ASSOCIATED WITH ACQUIRING OTHER COMPANIES
Part of the Company's strategy is to grow through mergers and
acquisitions of products, companies and businesses, and we intend in the
future to pursue additional acquisitions of complementary product lines,
technologies and businesses. We may have to issue debt or equity securities
to pay for future acquisitions, which could be dilutive to existing
shareholders. We have also incurred and may continue to incur certain
liabilities or other expenses in connection with acquisitions, which have and
could continue to materially adversely affect our business, financial
condition and results of operations. In addition, mergers and acquisitions
involve numerous other risks, including:
- difficulties assimilating the operations, personnel, technologies
and products of the acquired companies;
- diversion of management's attention from other business concerns;
- the potential loss of key employees of the acquired companies.
For these reasons, we cannot be certain what effect existing or future
acquisitions may have on our business, financial condition and results of
operations.
WE MUST COMPLETE THE INTEGRATION OF A COMPANY IN A FOREIGN COUNTRY
Our acquisition of PolyMASC in August 1999 involves the integration
of two companies that previously operated independently. The difficulties are
exacerbated by the fact that the two companies are located at three different
sites on two different continents separated by economic, governmental and
cultural differences. We have no prior experience integrating a European
operation. Difficulties in the integration process may include:
- diversion of management from the business of the combined
company;
- potential incompatibility of business cultures;
- problems associated with integration of management information
and reporting systems;
- potential inability to coordinate research and development
efforts successfully; and
- operating the combined company at three different sites in
California, Texas and England.
WE USE HAZARDOUS MATERIALS
Our research and development activities involve the controlled use of
hazardous materials. Although we believe that our safety procedures for handling
and disposing of these materials comply with applicable laws and regulations, we
cannot eliminate the risk of accidental contamination or injury from hazardous
materials. If a hazardous material accident occurred, we would be liable for any
resulting damages. This liability could exceed our financial resources.
Additionally, hazardous materials are subject to regulatory oversight. Accidents
unrelated to our operations could cause federal, state or local regulatory
agencies to restrict our access to hazardous materials needed in our research
and development efforts. If our access to these materials is limited, we could
experience delays in our research and development programs. Paying damages or
experiencing delays caused by restricted access could reduce our ability to
generate revenues and make it more difficult to fund our operations.
THE STOCK MARKET IS VOLATILE AND OUR STOCK PRICE COULD DECLINE
Market fluctuations or volatility could cause the market price of our
common stock to decline. In recent years the stock market in general and the
market for biotechnology- related companies in particular have experienced
extreme price and volume fluctuations, often unrelated to the operating
performances of the affected companies. Our common stock has experienced, and is
9.
<PAGE>
likely to continue to experience, these fluctuations in price, regardless of our
performance. These fluctuations could cause the market price of our common stock
to decline.
WE HAVE NEVER PAID DIVIDENDS.
We have never paid any cash dividends and do not anticipate paying cash
dividends in the foreseeable future.
10.
<PAGE>
FORWARD-LOOKING STATEMENTS
This prospectus, including the documents that we incorporate by
reference, contains forward-looking statements within the meaning of Section 27A
of the Securities Act and Section 21E of the Exchange Act. Any statements about
our expectations, beliefs, plans, objectives, assumptions or future events or
performance are not historical facts and may be forward-looking. These
statements are often, but not always, made through the use of words or phrases
such as "anticipate," "estimate," "plans," "projects," "continuing," "ongoing,"
"expects," "management believes," "we believe," "we intend" and similar words or
phrases. Accordingly, these statements involve estimates, assumptions and
uncertainties which could cause actual results to differ materially from those
expressed in them. Any forward-looking statements are qualified in their
entirety by reference to the factors discussed in this prospectus or
incorporated by reference.
Because the factors discussed in this prospectus or incorporated by
reference could cause actual results or outcomes to differ materially from those
expressed in any forward-looking statements made by us or on behalf of the
company, you should not place undue reliance on any such forward-looking
statements. Further, any forward-looking statement speaks only as of the date on
which it is made, and we undertake no obligation to update any forward-looking
statement or statements to reflect events or circumstances after the date on
which such statement is made or to reflect the occurrence of unanticipated
events. New factors emerge from time to time, and it is not possible for us to
predict which will arise. In addition, we cannot assess the impact of each
factor on our business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those contained in
any forward-looking statements.
USE OF PROCEEDS
We will not receive any proceeds from the sale of the shares of common
stock offered by the selling stockholders.
11.
<PAGE>
SELLING STOCKHOLDERS
We are registering for resale certain shares of our common stock held
by the selling stockholders identified below. The following table sets forth:
- the name of the selling stockholders;
- the number and percent of shares of our common stock that the
selling stockholders beneficially owned prior to the offering for
resale of any of the shares of our common stock being registered
by the registration statement of which this prospectus is a part;
- the number of shares of our common stock that may be offered for
resale for the account of the selling stockholders pursuant to
this prospectus; and
- the number and percent of shares of our common stock to be held
by the selling stockholders after the offering of the resale
shares (assuming all of the resale shares are sold by the selling
stockholders).
This information is based upon information provided by each
respective selling stockholder, schedules 13G and other public documents
filed with the SEC, and assumes the sale of all of the resale shares by the
selling stockholders. The term "selling stockholders" includes the
stockholders listed below and their transferees, pledgees, donees or other
successors. The applicable percentages of ownership are based on an aggregate
of 29,039,331 shares of common stock issued and outstanding as of May 30,
2000.
<TABLE>
<CAPTION>
SHARES BENEFICIALLY OWNED SHARES BENEFICIALLY OWNED
PRIOR TO OFFERING NUMBER OF SHARES AFTER OFFERING
SELLING STOCKHOLDERS NUMBER PERCENT BEING OFFERED NUMBER PERCENT
----------- -------------- ------------------ ------------ --------------
<S> <C> <C> <C> <C> <C>
STATE OF WISCONSIN INVESTMENT BOARD 1,031,030 3.6 % 500,000 531,030 1.8 %
121 East Wilson Street
Madison, WI 53702
BSI SA - LUGANO - SWITZERLAND 2,400,000 8.3 % 300,000 2,100,000 7.2 %
Via Magatti 2
6900 Lugano
Switzerland
BANCA INTERMOBILIARE DE INVESTIMENTI E 860,000 3.0 % 200,000 660,000 2.3 %
GESTIONI
Via Cransei No. 7 - 70121 Torino
Italy
COMPANIA INTERNACIONAL FINANCIERA SA 200,000 * 200,000 - *
c/o Back Office Solutions
31 bd Helvetique
CH-1244 Geneve 3
Switzerland
BAYSTAR CAPITAL LP 120,000 * 120,000 - *
425 Market Street, 22nd Floor
San Francisco, CA 94105
BAYSTAR INTERNATIONAL LTD 80,000 * 80,000 - *
425 Market Street, 22nd Floor
San Francisco, CA 94105
LEONARDO CAPITAL FUND 442,200 * 120,000 322,200 *
c/o Park Place Capital
25 St. James Street
London SW1 A1HA
England
12.
<PAGE>
MUNDER HEALTHCARE FUND 120,000 * 120,000 - *
Framlington Asset Management
155 Bishopsgate
London EC2M 3XJ
England
MERLIN BIOMED L.P. 150,000 * 60,000 90,000 *
230 Park Avenue, Suite 928
New York, NY 10169
MERLIN BIOMED INT'L, LTD 170,000 * 60,000 110,000 *
230 Park Avenue, Suite 928
New York, NY 10169
FINSBURY LIFE SCIENCES INVESTMENT TRUST PLC 188,757 * 34,391 154,366 *
12 Appold Street
London EC2A 2AW
England
FINSBURY TECHNOLOGY TRUST PLC 140,559 * 25,609 114,950 *
12 Appold Street
London EC2A 2AW
England
AL-BANK AL-SAUDI AL-ALAMI LTD 20,000 * 20,000 - *
One Knightsbridge
London SW1X 7XS
England
WERNER LIVING TRUST DATED 6/4/91 27,500 * 27,500 - *
THOMAS WERNER, TRUSTEE
c/o Main Street Advisors
3110 Main Street, Suite 300
Santa Monica, CA 90405
UNITED OAK, INC. 27,500 * 27,500 - *
c/o Main Street Advisors
3110 Main Street, Suite 300
Santa Monica, CA 90405
JEAN GOUTAL 8,000 * 6,000 2,000 *
c/o Main Street Advisors
3110 Main Street, Suite 300
Santa Monica, CA 90405
WACHTER FAMILY TRUST DATED 3/1/96 18,700 * 6,000 12,700 *
PAUL WACHTER, TRUSTEE
c/o Main Street Advisors
3110 Main Street, Suite 300
Santa Monica, CA 90405
DAVID CAPELL 4,000 * 4,000 - *
c/o Main Street Advisors
3110 Main Street, Suite 300
Santa Monica, CA 90405
GREGORY ALEXANDER 4,000 * 4,000 - *
c/o Main Street Advisors
3110 Main Street, Suite 300
Santa Monica, CA 90405
</TABLE>
* Less than 1%
13.
<PAGE>
PLAN OF DISTRIBUTION
The shares of common stock may be sold from time to time by the selling
stockholders in one or more transactions at fixed prices, at market prices at
the time of sale, at varying prices determined at the time of sale or at
negotiated prices. The selling stockholders may offer their shares of common
stock in one or more of the following transactions:
- on any national securities exchange or quotation service at which
the common stock may be listed or quoted at the time of sale,
including the Nasdaq National Market;
- in the over-the-counter market;
- in private transactions;
- through options; and
- by pledge to secure debts and other obligations, or a combination
of any of the above transactions.
If required, we will distribute a supplement to this prospectus to
describe material changes in the terms of the offering.
The shares of common stock described in this prospectus may be sold
from time to time directly by the selling stockholders. Alternatively, the
selling stockholders may from time to time offer shares of common stock to or
through underwriters, broker/dealers or agents. The selling stockholders and any
underwriters, broker/dealers or agents that participate in the distribution of
the shares of common stock may be deemed to be "underwriters" within the meaning
of the Securities Act of 1933. Any profits on the resale of shares of common
stock and any compensation received by any underwriter, broker/dealer or agent
may be deemed to be underwriting discounts and commissions under the Securities
Act of 1933.
Any shares covered by this prospectus which qualify for sale pursuant
to Rule 144 under the Securities Act of 1933 may be sold under rule 144 rather
than under the terms of this prospectus. The selling stockholders may not sell
all of the shares. The selling stockholders may transfer, will or gift such
shares by other means not described in this prospectus.
To comply with the securities laws of certain jurisdictions, the common
stock must be offered or sold only through registered or licensed brokers or
dealers. In addition, in certain jurisdictions, the common stock may not be
offered or sold unless they have been registered or qualified for sale or an
exemption is available and complied with.
Under the Securities Exchange Act of 1934, any person engaged in a
distribution of the common stock may not simultaneously engage in market-making
activities with respect to the common stock for nine business days prior to the
start of the distribution. In addition, each selling stockholder and any other
person participating in a distribution will be subject to the Securities
Exchange Act of 1934 which may limit the timing of purchases and sales of common
stock by the selling stockholders or any such other person. These factors may
affect the marketability of the common stock and the ability of brokers or
dealers to engage in market-making activities.
All expenses of this registration will be paid by Valentis. These
expenses include the SEC's filing fees and fees under state securities or "blue
sky" laws. We estimate that our expenses in connection with this offering will
be approximately $60,000. All expenses for the issuance of a supplement to
this prospectus, when requested by selling stockholder(s), will be paid by the
requesting stockholder(s).
LEGAL MATTERS
Latham & Watkins, Menlo Park, California will give its opinion that the
shares offered in this prospectus have been validly issued and are fully paid
and nonassessable. A partner of Latham & Watkins holds an aggregate of 300
shares of common stock of Valentis.
EXPERTS
Ernst & Young LLP, independent auditors, have audited our financial
statements included in our Annual Report on Form 10-K for the year ended June
30, 1999, as set forth in their report, which is incorporated by reference in
this prospectus and elsewhere in this registration statement. Our financial
statements are incorporated by reference in reliance on Ernst & Young LLP's
report, given on their authority as experts in accounting and auditing.
14.
<PAGE>
YOU SHOULD RELY ONLY ON THE INFORMATION CONTAINED IN THIS PROSPECTUS. WE HAVE
NOT AUTHORIZED ANYONE TO PROVIDE YOU WITH INFORMATION DIFFERENT FROM THAT
CONTAINED IN THIS PROSPECTUS OR ANY PROSPECTUS SUPPLEMENT. THIS PROSPECTUS IS
NOT AN OFFER OF THESE SECURITIES IN ANY JURISDICTION WHERE AN OFFER AND SALE IS
NOT PERMITTED. THE INFORMATION CONTAINED IN THIS PROSPECTUS IS ACCURATE ONLY AS
OF THE DATE OF THIS PROSPECTUS, REGARDLESS OF THE TIME OF DELIVERY OF THIS
PROSPECTUS OR ANY SALE OF OUR COMMON STOCK.
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
----
<S> <C>
WHERE YOU CAN GET MORE INFORMATION........................................... 2
VALENTIS, INC................................................................ 3
RISK FACTORS................................................................. 4
FORWARD-LOOKING STATEMENTS................................................... 11
USE OF PROCEEDS.............................................................. 11
SELLING STOCKHOLDERS......................................................... 12
PLAN OF DISTRIBUTION......................................................... 14
LEGAL MATTERS................................................................ 14
EXPERTS...................................................................... 14
</TABLE>
1,915,000 SHARES
COMMON STOCK
VALENTIS, INC.
PROSPECTUS
_________________, 2000
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The expenses in connection with the issuance and distribution of the
securities being registered are set forth in the following table (all amounts
except the registration fee and the listing fee are estimated):
<TABLE>
<S> <C>
SEC Registration Fee.................................... $ 3,744.30
Nasdaq National Market Listing Fee...................... $17,500.00
Legal fees and expenses................................. $25,000.00
Accounting fees and expenses............................ $10,000.00
Transfer agent fees..................................... $ 3,000.00
----------
Total.......................................... $59,244.30
==========
</TABLE>
ITEM 15. INDEMNIFICATION OF OFFICERS AND DIRECTORS.
The Registrant's Certificate of Incorporation and Bylaws include
provisions to (i) eliminate the personal liability of its directors for monetary
damages resulting from breaches of their fiduciary duty to the extent permitted
by Section 102(b)(7) of the DGCL and (ii) require the Registrant to indemnify
its directors and officers to the fullest extent permitted by applicable law,
including circumstances in which indemnification is otherwise discretionary.
Pursuant to Section 145 of the DGCL, a corporation generally has the power to
indemnify its present and former directors, officers, employees and agents
against expenses incurred by them in connection with any suit to which they are
or are threatened to be made, a party by reason of their serving in such
positions so long as they acted in good faith and in a manner they reasonably
believed to be in or not opposed to, the best interests of the corporation and
with respect to any criminal action, they had no reasonable cause to believe
their conduct was unlawful. The Registrant believes that these provisions are
necessary to attract and retain qualified persons as directors and officers.
These provisions do not eliminate the directors' or officers' duty of care, and,
in appropriate circumstances, equitable remedies such as injunctive or other
forms of non-monetary relief will remain available under the DGCL. In addition,
each director will continue to be subject to liability pursuant to Section 174
of the DGCL, for breach of the director's duty of loyalty to the Registrant, for
acts or omissions not in good faith or involving intentional misconduct, for
knowing violations of law, for acts or omissions that the director believes to
be contrary to the best interests of the Registrant or its stockholders, for any
transaction from which the director derived an improper personal benefit, for
acts or omissions involving a reckless disregard for the director's duty to the
Registrant or its stockholders when the director was aware or should have been
aware of a risk of serious injury to the Registrant or its stockholders, for
acts or omission that constitute an unexcused pattern of inattention that
amounts to an abdication of the director's duty to the Registrant or its
stockholders, for improper transactions between the director and the Registrant
and for improper loans to directors and officers. The provision also does not
affect a director's responsibilities under any other law, such as the federal
securities law or state or federal environmental laws.
The Registrant has entered into indemnity agreements with each of its
directors and executive officers that require the Registrant to indemnify such
persons against expenses, judgments, fines, settlements and other amounts
incurred (including expenses of a derivative action) in connection with any
proceeding, whether actual or threatened, to which any such person may be made a
party by reason of the fact that such person is or was a director or an
executive officer of the Registrant or any of its affiliated enterprises,
provided such person acted in good faith and in a manner such person reasonably
believed to be in or not opposed to the best interests of the Registrant and,
with respect to any criminal proceeding, had no reasonable cause to believe his
conduct was unlawful. The indemnification agreements also set forth certain
procedures that will apply in the event of a claim for indemnification
thereunder.
At present, there is no pending litigation or proceeding involving a
director or officer of the Registrant as to which indemnification is being
sought nor is the Registrant aware of any threatened litigation that may result
in claims for indemnification by any officer or director.
The Registrant has an insurance policy covering the officers and
directors of the Registrant with respect to certain liabilities, including
liabilities arising under the Securities Act or otherwise.
II-1.
<PAGE>
ITEM 16. EXHIBITS.
(a) Exhibits.
EXHIBIT NO. DESCRIPTION
-------------- ---------------------------------------------------------------
4.1 Share Purchase Agreement between the Registrant and the selling
stockholders, dated as of April 6, 2000
5.1 Opinion of Latham & Watkins.
10.1 Reference is made to Exhibit 4.1 above.
23.1 Consent of Ernst & Young, LLP, Independent Auditors.
23.2 Consent of Latham & Watkins. Reference is made to Exhibit 5.1.
24.1 Power of Attorney. Reference is made to page II-4.
ITEM 17. UNDERTAKINGS.
The undersigned Registrant hereby undertakes:
(1) To file, during any period during which offers or sales are
being made, a post-effective amendment to this registration statement;
(i) To include any prospectus required by Section 10(a)(3) of
the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising
after the effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate,
represent a fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or any decrease in volume
of securities offered (if the total dollar value of securities offered would not
exceed that which was registered) and any deviation from the low end or high end
of the estimated maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b) if, in the
aggregate, the changes in volume and price represent no more than 20% change in
the maximum aggregate offering price set forth in the "Calculation of
Registration Fee" table in the effective registration statement.
(iii) To include any material information with respect to the
plan of distribution not previously disclosed in the registration statement or
any material change to such information in the registration statement.
provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) do not apply if the
information required to be included in a post-effective amendment by those
paragraphs is contained in periodic reports filed with or furnished to the
Commission by the registrant pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934 that are incorporated by reference in the registration
statement.
(2) That, for purposes of determining liability under the
Securities Act of 1933, each such post-effective amendment shall be deemed to be
a new registration statement relating to the securities to be offered therein,
and the offering of such securities at that time shall be deemed to be an
initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective
amendment any of the securities being registered which shall remain unsold at
the termination of the offering.
The undersigned Registrant hereby undertakes that, for purposes of determining
any liability under the Securities Act of 1933, each filing of the registrant's
annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act
of 1934 (and, where applicable, each filing of an employee benefit plan's annual
report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is
incorporated by reference in the registration statement shall be deemed to be a
new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities Act may
be permitted to directors, officers and controlling persons of the registrant
pursuant to provisions described in Item 15, or otherwise, the registrant has
been advised that in the
II-2.
<PAGE>
opinion of the Securities and Exchange Commission such indemnification is
against public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the registrant of expenses incurred or
paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Securities Act and will be governed by the final
adjudication of such issue.
II-3.
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-3 and has duly caused this registration
statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Burlingame, State of California, on May 30, 2000.
VALENTIS, INC.
By: /s/ Benjamin F. McGraw, III
----------------------------------
Benjamin F. McGraw, III,
President and Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears
below constitutes and appoints Benjamin F. McGraw, III, his or her true and
lawful attorney-in-fact and agent, with full power of substitution and
resubstitution, for him or her and in his name, place and stead, in any and all
capacities, to sign any and all amendments (including post-effective amendments)
to this registration statement, and to file the same, with all exhibits thereto,
and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, full power and
authority to do and perform each and every act and thing requisite and necessary
to be done in connection therewith, as fully to all intents and purposes as he
or she might or could do in person, hereby ratifying and confirming all that
said attorney-in-fact and agent or his or her substitutes or substitute, may
lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this registration
statement has been signed by the following persons in the capacities and on the
dates indicated.
<TABLE>
<CAPTION>
SIGNATURES TITLE DATE
----------------------------------------- ----------------------------------------------------- --------------------
<S> <C> <C>
/s/ Benjamin F. McGraw, III Chairman, Chief Executive Office and May 30, 2000
----------------------------------------- President
Benjamin F. McGraw, III (Principal Executive Office)
/s/ Bennet L. Weintraub Vice President, Finance and Chief May 29, 2000
----------------------------------------- Financial Officer (Principal Financial and
Bennet L. Weintraub Accounting Officer)
/s/ Patrick G. Enright Director May 30, 2000
-----------------------------------------
Patrick G. Enright
/s/ Mark McDade Director May 30, 2000
-----------------------------------------
Mark McDade
Director
-----------------------------------------
Raju Kucherlapati
/s/ Bert W. O'Malley Director May 30, 2000
-------------------------------------------
Bert W. O'Malley
/s/ Arthur M. Pappas Director May 30, 2000
-------------------------------------------
Arthur M. Pappas
Director
-------------------------------------------
Gillian E. Francis
/s/ Stanley T. Crooke Director May 30, 2000
-------------------------------------------
Stanley T. Crooke
</TABLE>
II-4.
<PAGE>
<TABLE>
<CAPTION>
EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION
------------- ---------------------------------------------------------------
<S> <C>
4.1 Share Purchase Agreement between the Registrant and the selling
stockholders, dated as of April 6, 2000.
5.1 Opinion of Latham & Watkins.
10.1 Reference is made to Exhibit 4.1 above.
23.1 Consent of Ernst & Young, LLP, Independent Auditors.
23.2 Consent of Latham & Watkins. Reference is made to Exhibit 5.1.
24.1 Power of Attorney. Reference is made to page II-4.
</TABLE>
1.
