<PAGE>
As filed with the Securities and Exchange Commission on November 14, 2000
Registration No.
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--------------------------------------------------------------------------------
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
----------------
GenStar Therapeutics Corporation
(Formerly UroGen Corp.)
(Exact name of Registrant as specified in its charter)
----------------
Delaware
(State or other jurisdiction of incorporation or organization)
33-0687976
(I.R.S. Employer Identification Number)
10865 Altman Row
San Diego, CA 92121
(858) 450-5949
(Address, including zip code, and telephone number, including area code, of
Registrant's principal executive offices)
----------------
Robert E. Sobol, MD
Chief Executive Officer
GenStar Therapeutics Corporation
10865 Altman Row
San Diego, CA 92121
(858) 450-5949
(Name, address and telephone number of agent for service)
Copies to:
Dennis J. Doucette, Esq.
Luce Forward Hamilton & Scripps LLP
600 West Broadway, Suite 2600
San Diego, CA 92101
(619) 236-1414
----------------
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 reinvestment plans, please check the following box. [X]
If any of the securities being registered on this Form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box. [X]
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. [_]
Calculation of Registration Fee
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<TABLE>
<CAPTION>
Proposed
Proposed maximum
maximum aggregate
Title of each class of Amount to be offering price offering Amount of
securities to be registered registered(1) per unit(2) price(2) Registration fee
-----------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
Common Stock, $0.001 par value... 1,480,500 shares $12.50 $18,506,250 $4,886
</TABLE>
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(1) Represents the shares already issued plus estimated maximum number of
shares of the Common Stock of the Registrant which may be issued to the
Selling Security Holders upon exercise of the warrants for Common Stock. In
the event of a stock split, stock dividend or similar transaction involving
the Common Stock of the Registrant, in order to prevent dilution, the
number of shares registered shall be automatically increased to cover
additional shares in accordance with Rule 416 (a) under the Securities Act.
(2) Estimated solely for the purpose of calculating the registration fee in
accordance with Rule 457(c) under the Securities Act of 1933, as amended,
and based on the average of the bid and ask prices reported for such
securities on the American Stock Exchange on November 10, 2000.
----------------
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, as amended, or until the Registration Statement
shall become effective on such date as the Securities and Exchange Commission,
acting pursuant to said Section 8(a), may determine.
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<PAGE>
PROSPECTUS
GenStar Therapeutics Corporation
(Formerly UroGen Corp.)
1,480,500 Shares
Common Stock
----------------
The Selling Securityholders named on page 12 may offer for sale up to
1,480,500 shares of our common stock.
We will not receive any proceeds from the sale of the shares offered.
However, we may receive certain cash consideration in connection with exercises
of warrants.
The Selling Securityholders, directly, or through agents, brokers, dealers,
or underwriters to be designated, from time to time, may sell all or a portion
of the shares in one or more transactions or terms to be determined at the time
of sale. Any underwriters, brokers, dealers or agents may receive compensation
in the form of discounts, concessions or commissions from the Selling
Securityholders or commissions from purchases of shares for whom they may act
as agent.
On November 10, 2000, the closing price of our common stock, which is quoted
on the American Stock Exchange under the symbol "GNT," was $12.50 per share.
----------------
The common stock offered in this prospectus involves a high degree of risk.
See "risk factors" beginning on page 5.
----------------
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 November 14, 2000
<PAGE>
PROSPECTUS SUMMARY
You should read this summary together with the more detailed information and
our financial statements and notes appearing elsewhere in this prospectus.
GenStar Therapeutics Corporation
(Formerly UroGen Corp.)
We are a biotechnology company dedicated to the development of innovative
gene therapy products for the treatment of hemophilia, cancer and HIV/AIDS.
Gene therapy is technology that uses genetic materials as therapeutic agents to
treat disease. Gene therapy seeks to restore, augment or correct gene functions
either by the addition of normal genes or by neutralizing the activity of
defective genes. An essential requirement of gene therapy is a suitable
delivery system for introducing therapeutic genes into cells. Two major
approaches which have been used are viral and non-viral delivery systems, also
called vectors.
Prior to July 1998, we were a biotechnology company developing gene therapy
products for the diagnosis and treatment of prostate cancer. We had licensed
technology in this area and were evaluating gene delivery systems.
In July 1998, we acquired equipment from the gene therapy unit of Baxter
Healthcare Corporation together with exclusive rights to gene delivery
technologies in exchange for 1,841,219 shares of our common stock and 5,830
shares of our Series A Preferred Stock. The technology acquired from Baxter is
based upon gene transfer systems derived from a type of cold virus called an
adenovirus. We believe this adenoviral system provides superior gene transfer
efficiency and expression compared to other gene therapy approaches. Gene
expression is the biological process the body employs to make proteins from the
genetic code of DNA. High levels of gene expression mean that high levels of
proteins are made. The gene transfer system has been engineered to remove
nearly all of the original adenovirus genes which are then replaced with
therapeutic genes. These genetically engineered therapeutic viruses contain
less than 3% of the original adenovirus. We believe that removal of unwanted
adenoviral genes permits increased gene transfer capacity with a high level of
expression of the gene being delivered. In addition, there is improved safety
compared to standard gene transfer systems. Because these therapeutic viruses
are engineered to maximize the delivery of therapeutic genes, they are termed
"MAXIMUM-AD" vectors. These MAXIMUM-AD vectors retain the ability to infect
other cells and the efficient gene transfer characteristics of the original
adenoviruses. We believe that we have engineered capabilities into our MAXIMUM-
AD systems that provide for sustained, high level expression of the gene being
transferred. We believe our gene transfer and expression systems will advance
the capabilities of gene therapy for disease management, providing what we
believe to be efficient gene transfer and long term gene expression desired for
effective therapeutic treatments.
In May 2000, pursuant to a merger of Allegro Cell Systems, Inc. (Allegro)
into GenStar, we acquired all of the outstanding shares of Allegro in exchange
for 288,000 shares of our common stock, and an obligation to issue an
additional 12,000 shares of common stock. Allegro has a license to certain
technologies for the treatment and prevention of AIDS and for lentiviral gene
therapy.
The technology for the treatment of AIDS is based upon vaccination with a
genetically modified HIV virus. The modified virus is incapable of replication
and suitable for administration to humans. The modified virus is still capable
of infecting cells and expressing HIV genes resulting in the generation of
immune responses that eradicate HIV infected cells. The lentiviral gene therapy
delivery technology was designed for therapeutic applications.
2
<PAGE>
Our current activities consist of the development of the gene transfer
system in our Factor VIII MAXIMUM-AD product for hemophilia, our tumor killing
IL-3 viral vector product for prostate cancer, and AIDS and lentiviral gene
therapy development work. Three gene therapy products are under development: 1)
Factor VIII MAXIMUM-AD Vector for the treatment of hemophilia; 2) Tumor Killing
Interleukin-3 (IL-3) Adenoviral Vectors for the treatment of prostate cancer;
and 3) Lentivirus based vaccine for the treatment and prevention of HIV/AIDS.
The Factor VIII MAXIMUM-AD Vector for hemophilia is expected to provide a
greater duration of the normally occurring protein, Factor VIII, reducing
chronic bleeding and joint damage which are characteristic of this disorder.
The IL-3 adenoviral product is comprised of a mixture of two adenoviral vectors
which complement each other, resulting in replication of the virus in tumor
tissues, leading to the destruction of tumor cells, radiation sensitization and
anti-tumor immune responses for the treatment of prostate cancer. The
Lentivirus Vector is a genetically modified HIV virus in which the viral genes
nef and env have been eliminated, rendering the virus incapable of replication
and suitable for vaccinating humans. We anticipate defining additional uses for
our vector technology and potentially acquiring other technologies.
We were incorporated as UroGen Corp. in Delaware in June 1995 as a wholly-
owned subsidiary of Medstone International, Inc., a Delaware corporation. Our
business was formed from the molecular biology and small molecule
pharmaceuticals divisions of Medstone. We had operated as two divisions of
Medstone from July 1, 1991 to December 29, 1995 when Medstone transferred the
operations of these divisions into our company. On February 9, 1996, Medstone
distributed all of our outstanding stock to its shareholders by issuing a
dividend of one share of our common stock for each share of Medstone stock held
as of December 29, 1995. In March 2000, we changed our name from UroGen Corp.
to GenStar Therapeutics Corporation. Our principal executive offices are
located at 10865 Altman Row, San Diego, California 92121, and our telephone
number is (858) 450-5949.
3
<PAGE>
THE OFFERING
<TABLE>
<C> <S>
Common stock offered by GenStar................... None
Common stock offered by the selling stockholders.. 1,480,500 shares, including
513,500 shares issuable
upon exercise of the
warrants
Common stock outstanding after the offering....... 22,663,829 shares,
23,377,329 shares assuming
all 513,500 shares are
issued upon exercise of the
warrants
Use of proceeds................................... GenStar will not receive
proceeds from the sale of
the shares offered. The
warrants include a net
exercise provision.
Accordingly, we may not
receive significant
proceeds from exercise of
the warrants.
</TABLE>
The above number of shares outstanding after the offering is based on the
shares outstanding as of September 30, 2000. This number excludes:
. 4,450,583 shares subject to outstanding options at a weighted average
exercise price of $2.35 as of September 30, 2000.
. 2,629,117 shares issuable upon exercise of outstanding warrants, other
than those which are a subject of this prospectus, at a weighted average
exercise price of $0.64 per share as of September 30, 2000.
. An aggregate of 1,140,098 shares available for future issuance under our
stock option plans as of September 30, 2000.
Refer to "Risk Factors" for additional information.
4
<PAGE>
RISK FACTORS
An investment in our common stock involves a high degree of risk. You should
carefully consider the risks described below and the other information
contained in this prospectus before deciding to invest in our common stock. The
risks described below are not the only ones facing our company. Additional
risks not presently known to us or which we currently consider immaterial may
also adversely affect our business. If any of the following risks actually
happen, our business, financial condition and operating results could be
materially adversely affected. In this case, the trading price of our common
stock could decline, and you could lose part or all of your investment.
This prospectus contains forward-looking statements that involve risks and
uncertainties. The statements contained in this prospectus that are not purely
historical are forward-looking statements, including statements regarding our
expectations, beliefs, intentions or strategies regarding the future. All
forward-looking statements included in this document are based on information
available to GenStar on the date of this prospectus. Our actual results could
differ materially from those anticipated in these forward-looking statements as
a result of various factors, including those set forth in the following risk
factors and elsewhere in this prospectus.
GENSTAR RISKS
We will need substantial additional funding which may not be available to us
and may limit our growth.
Although we raised $25.3 million dollars in the first quarter of fiscal
2000, from which we expect to fund operations until the middle of 2002, our
operations to date have consumed substantial amounts of cash and have generated
insignificant revenues. The negative cash flow from operations is expected to
continue and to accelerate for at least the next four years. The development of
our products will require a commitment of substantial funds to conduct the
costly and time-consuming research, preclinical and clinical testing necessary
to bring our products to market and to establish manufacturing and marketing
capabilities. GenStar's future capital requirements will depend on many
factors:
. the progress of our research and development programs;
. the progress of preclinical and clinical testing;
. the time and cost involved in obtaining regulatory approvals;
. the cost of filing, prosecuting, defending and enforcing patent claims
and other intellectual property rights;
. competing technological and market developments; and
. our ability to establish collaborative and other arrangements with third
parties, such as licensing and manufacturing agreements.
Baxter has committed to fund the development of our hemophilia product under
the Developmental Collaboration Agreement until we treat the first patient in
Phase I clinical trials, at which time they will pay us a $2 million milestone
payment. We cannot be certain that we will ever receive the milestone payment.
We expect that our existing capital resources and the amounts committed by
Baxter will enable us to maintain our current and planned operations until the
middle of 2002. We will need to raise substantial additional capital to fund
our operations. We intend to seek this additional funding either through
collaborative arrangements or through public or private equity or debt
financings. We cannot be certain that additional financing will be available on
acceptable terms, or at all. If we raise additional funds by issuing equity
securities you will experience further dilution with respect to the stock
registered in this offering. If adequate funds are not available, we may be
required to delay or reduce the scope of our operations or to obtain funds
through arrangements with collaborative partners or others that may require us
to relinquish rights we may have acquired in the interim.
5
<PAGE>
We are in the early stage of product development. Our technology requires
additional research and development, clinical testing and regulatory clearances
prior to marketing our products. If any of our potential products fail, our
business may not succeed.
Our products are in the early stages of development. They will require
additional research and development, clinical testing and regulatory
clearances. We currently do not sell any products and do not expect to have any
products commercially available for at least four years. Our proposed products
are subject to the risks of failure inherent in the development of gene therapy
products based on innovative technologies.
As a result, we are not able to predict whether our research and development
activities will result in any commercially viable products or applications. In
our industry, the majority of the potential products fail to enter clinical
studies, and the majority of products entering clinical studies after achieving
promising preclinical results are not commercialized successfully.
We have limited manufacturing experience and marketing experience, which may
impair the sale of our products.
We cannot guarantee that we will be able to develop manufacturing or
marketing capabilities successfully, either on our own or through third
parties. To date, we have engaged only in the development of pharmaceutical
technology and products, and have more limited experience in manufacturing or
procuring products in commercial quantities or in marketing pharmaceutical
products. We have only limited experience in conducting clinical trials and
other later-stage phases of the regulatory approval process. We cannot be
certain that we will be able to engage successfully in any of these activities
for any of the products we attempt to commercialize.
Our business is expanding rapidly and our business prospects may suffer if
we are not able to effectively manage the growth of our operations, retain
employees and successfully integrate new personnel.
We currently plan to expand our operations to include development of our
prostate cancer, AIDS and lentiviral gene therapy programs and other programs
yet to be identified. Additionally, while we currently have a manufacturing
facility to produce material for Phase I and II clinical trials, if we decide
to establish a commercial-scale manufacturing facility, we will require
substantial additional funds and personnel and will be required to comply with
extensive regulations applicable to such a facility. This growth may strain our
management and operations. Our ability to manage such growth depends on the
ability of our officers and key employees to:
. broaden our management team and to attract, hire and retain skilled
employees;
. implement and improve our operational, management information and
financial control systems;
. expand, train and manage our employee base; and
. develop additional expertise among existing management personnel.
We depend on future collaborations with others, which may be difficult to
obtain, and our revenues may depend on the efforts of third parties.
Our strategy for the development, clinical testing, manufacturing and
commercialization of our products includes entering into various collaborations
with corporate partners, licensors, licensees and others. We have entered into
a distribution agreement with Baxter Healthcare Corporation under which Baxter
has the exclusive right to market, sell and distribute the hemophilia product.
Therefore, any revenues we may receive from the hemophilia product are
dependent on the efforts of Baxter. To the extent that we enter into additional
co-promotion, distribution or other licensing arrangements, any revenues we
receive will depend on the efforts of the other parties in these arrangements.
6
<PAGE>
We may not be able to negotiate these collaborative arrangements on
acceptable terms, if at all. Even if we enter into these collaborative
arrangements, they may not be successful. If we are unable to establish these
arrangements, we would need to raise additional capital to undertake these
activities at our own expense. In addition, we may encounter significant delays
in introducing our products into some markets or find that the development,
manufacture or sale of our products in these markets is adversely affected by
the absence of these collaborative agreements.
We are a development stage company with a limited operating history; we
expect continued losses and may never become profitable.
We are considered a development stage company because we have not yet
generated revenues from sales. From our inception in July 1991 through
September 30, 2000, we have incurred cumulative losses of approximately $22.9
million, almost all of which consisted of research and development and general
and administrative expenses. We expect our losses to increase in the future as
we begin our clinical trials and increase our research and development
activities. It is possible that we may never achieve significant revenues or
become profitable.
Even if we eventually generate revenues from sales, we expect to incur
significant operating losses over the next several years. Our ability to become
profitable and to achieve long-term success will depend on:
. the time and expense necessary to develop our proposed products;
. whether and how quickly we can obtain regulatory approvals for proposed
products; and
. our success in bringing these products to market.
Inability to protect our technologies through patent protection could allow
our competitors to exploit our proprietary products and technologies.
We actively pursue patent protection for our proprietary products and
technologies. We hold or have licensed rights to two U.S. patents and currently
have or have licensed rights to 14 U.S. patent applications pending and several
foreign patent applications pending. In addition, we have numerous foreign
patent applications pending corresponding to our U.S. patents. However, our
patents may not protect us against our competitors. We may be required to file
suit to protect our patents, and we cannot be certain that we will have the
resources necessary to pursue such litigation or otherwise protect our patent
rights.
We also rely on trade secret protection for our unpatented proprietary
technology. However, trade secrets are difficult to protect. Others could
develop substantially equivalent information or gain access to our trade
secrets.
We have a policy requiring that our employees and consultants execute
proprietary information agreements upon commencement of employment or
consulting relationships. These agreements provide that all confidential
information developed or made known to the individual during the course of the
relationship must be kept confidential except in specified circumstances.
However, these agreements may not successfully protect our trade secrets or
other proprietary information.
Others could assert claims against us based on their patents. Claims could
seek damages as well as an injunction prohibiting clinical testing,
manufacturing and marketing of the product at issue. If any of these actions
are successful, in addition to any potential liability for damages, we could be
required to obtain a license in order to continue to manufacture or market the
product at issue. It is possible that any license required under any patent
would not be made available on acceptable terms, if at all. There has been, and
we believe that there will continue to be, significant litigation in the
pharmaceutical industry regarding patent and other intellectual property
rights. If we become involved in any litigation, a substantial portion of our
financial and personnel resources could be consumed, regardless of the outcome
of litigation.
7
<PAGE>
Competition for highly-skilled personnel is intense and the success of our
business depends on our ability to attract and retain key personnel.
Our future success, if any, depends to a significant degree upon the
continued service of key technical and senior management personnel,
particularly Paul D. Quadros and Robert E. Sobol, MD, the loss of whose
services might significantly delay our product development and
commercialization efforts. We do not have agreements with Mr. Quadros or Mr.
Sobol which would assure retention of their services for more than sixty days.
We will also need substantial additional expertise in the areas of
manufacturing, marketing and finance, among others, in order to achieve our
business objectives. Competition for qualified personnel is intense, and the
loss of key personnel or the inability to attract and retain the additional
skilled personnel required for the expansion of our business could damage our
business.
INDUSTRY RISKS
Clinical trials are designed to test the safety and efficacy of our
potential products in human subjects. Successful clinical trials depend on the
complexity of the potential product and the rate of patient enrollment. If the
clinical trials are not successful, we will incur additional expense and/or our
potential products may not be approved for sale.
Extensive and costly clinical testing will be necessary to assess the safety
and efficacy of our potential products. The rate of completion of clinical
trials depends on, among other factors, the type, novelty and complexity of the
product and the rate of patient enrollment. Patient enrollment is a function of
many factors, including:
. the nature of the clinical trial protocols;
. the existence of competing protocols;
. size of the patient population;
. proximity of patients to clinical sites; and
. eligibility criteria for the study.
Our initial clinical trial will be for our hemophilia product. There are
other companies conducting clinical trials in patients with hemophilia. As a
result, we must compete with them for clinical sites, physicians and the
limited number of patients with hemophilia who fulfill the stringent
requirements for participation in clinical trials. Delays in patient enrollment
will increase costs and delay the introduction of our potential products,
thereby harming our business and financial condition.
Even if we successfully enroll subjects in our clinical trials, we cannot
guarantee they will respond to our potential products. If we do not comply with
the U.S. Food and Drug Administration regulations applicable to clinical
trials, our trials could be delayed, suspended or canceled, or the FDA might
not accept the results of our trials. The potential for adverse results exists
with any clinical trial. The FDA may suspend clinical trials at any time if it
concludes that the subjects participating in our trials are being exposed to
unacceptable health risks. Further, we cannot assure you that human clinical
testing will show any current or future product candidate to be safe and
effective or assure you that if approved, such products would be accepted or
successful in the marketplace.
We face intense competition and must cope with rapid technological change,
which may adversely affect earnings and financial condition and/or render our
potential products obsolete.
We are engaged in gene transfer research, which is a rapidly changing field.
Existing products and therapies to treat hemophilia and prostate disorders will
compete directly with the products that we are seeking to develop and market.
Competition from fully integrated pharmaceutical companies and more established
8
<PAGE>
biotechnology companies is expected to increase. Most of these companies have
significantly greater financial resources and expertise than we do in the
following areas:
. research and development;
. manufacturing;
. preclinical and clinical testing;
. obtaining regulatory approvals; and
. marketing.
Smaller companies may also prove to be significant competitors, particularly
through collaborative arrangements with large pharmaceutical companies. Many of
these competitors have significant products approved or in development and
operate large, well-funded research and development programs.
Academic institutions, governmental agencies and other public and private
research organizations also conduct research, seek patent protection and
establish collaborative arrangements for product and clinical development and
marketing. These companies and institutions also compete with us in recruiting
and retaining highly qualified scientific and management personnel.
In addition, our competitors may develop more effective or more affordable
products, or achieve earlier patent protection or product commercialization and
market penetration than we will. Additionally, technologies developed by our
competitors may render our potential products uneconomical or obsolete, and we
may not be successful in marketing our potential products against competitors.
We need to comply with significant government regulation to obtain product
approvals and to market products after approvals. Compliance with government
regulation can be a costly and time consuming process, with no assurance of
ultimate approval. If these approvals are not obtained, we will not be able to
sell our potential products.
Various agencies in the United States and abroad regulate the testing,
manufacturing, labeling, distribution, marketing and advertising of proposed
products and ongoing research and development activities. The U.S. Food and
Drug Administration, the U.S. National Institutes of Health and comparable
agencies in foreign countries impose many requirements on the introduction of
new pharmaceutical products through lengthy and detailed clinical testing
procedures, and other costly and time consuming compliance procedures. These
requirements make it difficult to estimate when our potential products will be
commercially available, if at all.
Our potential products will require substantial clinical trials and FDA
review as new drugs. We cannot predict with certainty when we might submit any
of our proposed products currently under development for regulatory review.
Once we submit a product for review, we cannot guarantee that FDA or other
regulatory approvals will be granted on a timely basis, if at all.
If we are delayed or fail to obtain required approvals, our business and
results of operations would be damaged. If we fail to comply with regulatory
requirements, either prior to approval or in marketing our products after
approval, we could be subject to regulatory or judicial enforcement actions.
These actions could result in:
. product recalls or seizures;
. injunctions;
. civil penalties;
. criminal prosecution;
. refusal to approve new products and withdrawal of existing approvals; and
. enhanced exposure to product liabilities.
9
<PAGE>
If we sell our products outside the U.S., we will be subject to regulatory
requirements governing these sales. These requirements vary widely from
country to country and could delay introduction of our products in those
countries.
The pricing of our product may depend on third-party payors, whose
reimbursement and/or cost control policies may limit the revenues from our
products.
In both domestic and foreign markets, sales of our products, if any, will
depend, in part, on the extent to which third-party payors, including
government agencies such as Medicare, managed care providers and private
health insurers will reimburse users for the costs of our products and any
related treatments. If those who buy our products are not adequately
reimbursed, they may forego or reduce use.
Third-party payors are engaged in ongoing efforts to reduce the costs of
pharmaceutical products. In the United States, an increasing emphasis on
managed care and consolidation of hospital purchasing has and is expected to
continue to place pressure on pharmaceutical prices, and may reduce the prices
we can charge for our potential products. In many major foreign markets,
pricing approval is required before sales can commence and prices are often
set by governmental authorities. These price controls are subject to change at
unpredictable times. Market acceptance of our potential products will be
severely curtailed if adequate coverage and reimbursement levels are not
provided by governmental authorities and private third-party payors.
We face the risk of product liability claims, which could affect our
earnings and financial condition.
Our business will expose us to potential product liability risks that are
inherent in the testing, manufacturing and marketing of human therapeutic
products. Product liability results from harm to patients using our potential
product that was Either not communicated as a potential side-effect, or was
more extreme than communicated. We will require all patients enrolled in the
clinical trials to sign consents, which explain the risks involved with
participating in the trial. The consents, however, provide only a limited
level of protection and product liability insurance will be required. We may
not be able to obtain and maintain product liability insurance for all of our
clinical trials. We may not be able to obtain or maintain product liability
insurance in the future on acceptable terms or with adequate coverage against
potential liabilities which would expose us to potential product liability.
Accidents related to hazardous materials used in our research and
development efforts could subject us to significant liability.
Our research and development efforts involve the controlled use of
radioactive and hazardous materials and biological hazardous materials, such
as isopropyl alcohol, ethanol, bromides and viruses. Although we believe that
our safety procedures for handling and disposing of these materials comply
with the standards prescribed by state and federal regulations, the risk of
accidental contamination or injury from these materials cannot be completely
eliminated. In the event of an accident, we could be held liable for any
damages that result and any liability could exceed our resources.
RISKS RELATED TO THIS OFFERING
There may be an adverse impact on the value of your investment from shares
eligible for future sale.
Sales of shares of our common stock in the public market, including shares
being registered in this prospectus and shares which will be issued when stock
options are exercised, could have an adverse effect on the market price of our
common stock. The common stock being registered for resale in this prospectus
represents 7% of our total outstanding shares, assuming exercise of all of the
warrants being registered. Sales of this stock might also make it more
difficult for us to sell equity securities and equity-related securities in
the future at a time and price that is acceptable.
10
<PAGE>
USE OF PROCEEDS
We will not receive proceeds from the sale of the common stock offered in
this prospectus. The maximum amount we could receive upon exercise of the
warrants is $385,125. However, the warrants include a "net exercise" provision,
where the investors can elect to receive fewer shares upon exercise rather than
pay the exercise price in cash. Accordingly, we may not receive significant
proceeds from the exercise of the warrants. In addition, as the warrants can be
exercised at any time until January 21, 2005 and are exercisable at the option
of the holder, we cannot predict when we might receive any cash proceeds, if at
all. Any amount we do receive will be used for general working capital
purposes.
11
<PAGE>
SELLING SECURITYHOLDERS
The following table sets forth information with respect to each Selling
Securityholder, the respective number of shares of common stock beneficially
owned by them as of the date of this prospectus, the number of shares offered
for their respective accounts, and the percentage of and amount of shares
beneficially owned by each Selling Securityholder. All of these shares were
held of record with sole voting and investment power, subject to applicable
community property laws, by the named individual and/or by his/her spouse,
except as indicated in the footnotes below. For each Selling Securityholder,
the number of shares beneficially owned includes shares issuable upon exercise
of warrants for which the underlying shares are covered by this prospectus.
Because the Selling Securityholders may offer all or some portion of the shares
of common stock being offered pursuant to this prospectus, no estimate can be
given as to the amount of the common stock that will be held by the Selling
Securityholders upon termination of any sales. None of the Selling
Securityholders has had any position, office or other material relationship
with us in the past three years.
<TABLE>
<CAPTION>
Shares
Beneficially Owned
Assuming All
Shares Number Shares Offered
Beneficially of are Sold
Owned Prior Shares ------------------
Selling Securityholders to Sale(1) Offered Number Percent (%)
----------------------- ------------ ------- ------ -----------
<S> <C> <C> <C> <C>
Wayne Rothbaum(2)..................... 640,500 640,500 -- --
Mitchell Silber(3).................... 540,000 540,000 -- --
Wong-Stall Family Trust............... 234,000 234,000 -- --
Drs. Malcolm Mitchell and June Kan
Mitchell............................. 27,000 27,000 -- --
Craig S. Andrews...................... 22,500 22,500 -- --
Dr. Tina Nova......................... 1,500 1,500 -- --
Eric Poeschla......................... 1,500 1,500 -- --
David Looney.......................... 1,500 1,500 -- --
Shellwater & Co.(4)................... 12,000 12,000 -- --
</TABLE>
--------
(1) Pursuant to the rules of the Commission, shares of common stock which an
individual or group has a right to acquire within 60 days pursuant to the
exercise of options or warrants or other convertible securities are deemed
to be outstanding for the purpose of computing the percentage of ownership
of such individual or group, but are not deemed to be outstanding for the
purpose of computing the percentage ownership of any other person sharing
in the stocks.
(2) Includes 363,500 shares issuable upon exercise of presently outstanding
warrants for common stock.
(3) Includes 150,000 shares issuable upon exercise of presently outstanding
warrants for common stock.
(4) Shellwater & Co. (an affiliate of the regents of the University of
California) has the right to acquire 12,000 shares of common stock pursuant
to the terms of the merger with Allegro.
12
<PAGE>
PLAN OF DISTRIBUTION
We will not receive any of the proceeds of the sale of the shares offered in
this prospectus. The shares of common stock may be sold from time to time to
purchasers directly by the Selling Securityholders. Alternatively, the Selling
Securityholders may from time to time offer the shares through brokers, dealers
or agents who may receive compensation in the form of discounts, concessions or
commissions from the Selling Securityholders and/or the purchasers of the
shares for whom they may act as agent. The Selling Securityholders and any such
brokers, dealers or agents who participate in the distribution of the shares
may be deemed to be "underwriters" and any profits on the sale of the shares by
them and any discounts, commissions or concessions received by any such
brokers, dealers or agents might be deemed to be underwriting discounts and
commissions under the Securities Act. To the extent the Selling Securityholders
may be deemed to be underwriters, the Selling Securityholders may be subject to
certain statutory liabilities, including, but not limited to, under Sections
11, 12 and 17 of the Securities Act and Rule 10b-5 under the Exchange Act.
The shares offered hereby may be sold from time to time in one or more
transactions at fixed prices, at prevailing market prices at the time of sale,
at varying prices determined at the time of sale or at negotiated prices. The
shares may be sold by one or more of the following methods, without limitation:
. a block trade in which the broker or dealer so engaged will attempt to
sell the shares as agent but may position and resell a portion of the
block as principal to facilitate the transaction;
. purchases by a broker or dealer as principal and resale by such broker or
dealer for its account pursuant to this prospectus;
. ordinary brokerage transactions and transactions in which the broker
solicits purchasers;
. an exchange distribution in accordance with the rules of such exchange;
. face-to-face transactions between sellers and purchasers without a
broker-dealer and;
. through the writing of options.
At any time a particular offer of the shares is made, a revised prospectus
or prospectus supplement, if required, will be distributed which will set forth
the aggregate amount and type of shares being offered and the terms of the
offering, including the name or names of any underwriters, dealers or agents,
any discounts, commissions, concessions and other items constituting
compensation from the Selling Securityholders and any discounts, commissions or
concessions allowed or are allowed or paid to dealers. The prospectus
supplement and, if necessary, a post-effective amendment to the registration
statement of which this prospectus is a part, will be filed with the Commission
to reflect the disclosure of additional information with respect to the
distribution of the Securities. In addition, the shares covered by this
prospectus may be sold in private transactions or under Rule 144 rather than
pursuant to this prospectus.
To the best of our knowledge, there are currently no plans, arrangement or
understandings between any Selling Securityholders and any broker, dealer,
agent or underwriter regarding the sale of the shares by the Selling
Securityholders. There is no assurance that any Selling Securityholder will
sell any or all of the shares offered by it hereunder or that any such Selling
Securityholder will not transfer, devise or gift such Securities by other means
not described in this prospectus.
The Selling Securityholders and any other person participating in such
distribution will be subject to applicable provisions of the Exchange Act and
the rules and regulations thereunder, including, without limitation, Regulation
M which may limit the timing of purchases and sales of any of the shares by the
Selling Securityholders and any other such person. Furthermore, Regulation M of
the Exchange Act may restrict the ability of any person engaged in the
distribution of the shares to engage in market-making activities with respect
to the particular shares being distributed for a period of up to five business
days prior to the
13
<PAGE>
commencement of such distribution. All of the foregoing may affect the
marketability of the shares and the ability of any person or entity to engage
in market-making activities with respect to the shares.
Pursuant to the Registration Rights Agreement entered into in connection
with the offer and sale of the Notes by the Company, each of the Company and
the Selling Securityholders will be indemnified by the other against certain
liabilities, including certain liabilities under the Securities Act, or will be
entitled to contribution in connection therewith.
GenStar has agreed to pay substantially all of the expenses incidental to
the registration, offering and sale of the Securities to the public other than
commissions, fees and discounts of underwriters, brokers, dealers and agents.
LEGAL MATTERS
The validity of the Common Stock being offered hereby will be passed upon
for us by Luce Forward Hamilton & Scripps LLP, San Diego, California.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The Commission allows us to "incorporate by reference" into this prospectus
the documents we file with them, which means that we can disclose important
information to you by referring you to these documents. The information that we
incorporate by reference into this prospectus is considered to be part of this
prospectus, and information that we file later with the Commission
automatically updates and supersedes any information in this prospectus. We
incorporate by reference into this prospectus the documents listed below:
. Annual Report on Form 10-KSB for the fiscal year ended December 31, 1999,
as filed with the Commission on March 30, 2000, under Section 13(a) of
the Securities Exchange Act of 1934, as amended (the "Exchange Act");
. Current Report on Form 8-K, as filed with the Commission on April 11,
2000;
. The description of our common stock contained in our Registration
Statement on Form 8-A, as filed with the Commission on April 17, 2000
under the Exchange Act, including any amendment or report filed for the
purpose of updating such description;
. Quarterly Reports on Form 10-QSB for the quarterly periods ended March
31, 2000 and June 30, 2000, as filed with the Commission on May 9, 2000
and August 4, 2000, respectively, under the Exchange Act;
. All other reports filed by us under Section 13(a) or 15(d) of the
Securities Exchange Act of 1934 since the end of our fiscal year ended
December 31, 1999.
All documents we have filed with the Commission under Sections 13(a), 13(c),
14 or 15(d) of the Securities Exchange Act of 1934 subsequent to the date of
this prospectus and prior to the filing of a post-effective amendment
indicating that all securities offered have been sold (or which re-registers
all securities then remaining unsold), are deemed to be incorporated in this
prospectus by this reference and to be made a part of this prospectus from the
date of filing of such documents.
We will provide, without charge, upon written or oral request of any person,
including a beneficial owner, to whom a copy of this prospectus is delivered, a
copy of any or all of the foregoing documents and information that has been or
may be incorporated in this prospectus by reference. Requests for such
documents and information should be directed to GenStar Therapeutics
Corporation, Attention: Carin Sandvik, Corporate Controller and Corporate
Secretary, 10865 Altman Row, San Diego, California 92121, telephone number
(858) 450-5949.
14
<PAGE>
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational requirements of the Securities Exchange
Act of 1934, as amended, and in accordance therewith file reports, proxy and
information statements, and other information with the Commission. Such
reports, proxy and information statements, and other information filed by us
can be inspected and copied at the public reference facilities maintained by
the Commission at Room 1024, 450 Fifth Street, N.W., Washington, D.C. 20549, as
well as the regional offices of the Commission located at Citicorp Center, 500
West Madison Street, Suite 1400, Chicago, Illinois 60661, and Seven World Trade
Center, Suite 1300, New York, New York 10048. Copies of such material can be
obtained from the Public Reference Section of the Commission at 450 Fifth
Street, N.W., Washington, D.C. 20549 at prescribed rates. You may obtain
information on the operation of Public Reference Room by calling the SEC at 1-
800-SEC-0330. Such reports, proxy statements and other information can also be
inspected at the offices of the National Association of Securities Dealers,
Inc. at 1735 K Street, N.W., Washington, D.C. 20006. The Commission maintains a
World Wide Web site that contains reports, proxy and information statements,
and other information that are filed through the Commission's Electronic Data
Gathering, Analysis and Retrieval System. This Web site can be accessed at
http://www.sec.gov.
We have filed with the Commission a Registration Statement on Form S-3 under
the Securities Act with respect to the common stock offered in this prospectus.
This prospectus does not contain all of the information set forth in the
registration statement and the exhibits and schedules thereto, certain parts of
which are omitted in accordance with the rules and regulations of the
Commission. For further information with respect to us, 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 described above.
15
<PAGE>
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No dealer, salesman or any other person has been authorized to give any
information or to make any representations other than those contained in this
Prospectus, in connection with the offer made by this Prospectus, and, if
given or made, such information or representations must not be relied upon as
having been authorized by the corporation. Neither the delivery of this
Prospectus nor any sale made hereunder shall, under any circumstances, create
an implication that there has been no change in the affairs of the corporation
since the date hereof. This Prospectus does not constitute an offer or
solicitation by anyone in any jurisdiction in which such offer or solicitation
is not authorized or in which the person making such offer or solicitation is
not authorized to do so or to anyone to whom it is unlawful to make such offer
or solicitation in such jurisdiction.
---------------
TABLE OF CONTENTS
<TABLE>
<CAPTION>
Page
----
<S> <C>
Prospectus Summary......................................................... 2
GenStar Therapeutics Corporation........................................... 2
The Offering............................................................... 4
Risk Factors............................................................... 5
Use of Proceeds............................................................ 11
Selling Securityholders.................................................... 12
Plan of Distribution....................................................... 13
Legal Matters.............................................................. 14
Incorporation of Certain Documents by Reference............................ 14
Where you can find more information........................................ 15
</TABLE>
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GenStar Therapeutics Corporation
1,480,500 Shares of Common Stock
---------------
PROSPECTUS
---------------
November 14, 2000
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the various expenses payable by us in
connection with the sale and distribution of the securities being registered
hereby. Normal commission expenses and brokerage fees are payable individually
by the Selling Securityholders. All amounts are estimated except the Securities
and Exchange Commission registration fee.
<TABLE>
<CAPTION>
Amount
-------
<S> <C>
SEC registration fee................................................ $ 4,886
Accounting fees and expenses........................................ 5,000
Legal fees and expenses............................................. 8,000
Printing expenses................................................... 3,000
Miscellaneous fees and expenses..................................... 1,000
-------
Total............................................................. $21,886
=======
</TABLE>
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Under Section 145 of the Delaware General Corporation Law, we have broad
powers to indemnify our directors and officers against liabilities they may
incur in such capacities, including liabilities under Securities Act. Our
Bylaws provide that we will indemnify our directors and executive officers and
may indemnify other officers to the fullest extent permitted by law. Under our
Bylaws, indemnified parties are entitled to indemnification for negligence,
gross negligence and otherwise to the fullest extent permitted by law. The
Bylaws also require us to advance litigation expenses in the case of
stockholder derivative actions or other actions. The indemnified party is
required to repay such advances if it is ultimately determined that the
indemnified party is not entitled to indemnification.
In addition, our Certificate of Incorporation provides that, pursuant to
Delaware law, our directors shall not be liable for monetary damages for breach
of the directors' fiduciary duty of care to us and our stockholders. This
provision in the Certificate of Incorporation does not eliminate the duty of
care, and in appropriate circumstances equitable remedies such as injunctive or
other forms of non-monetary relief will remain available under Delaware law. In
addition, each director is subject to liability for breach of the director's
duty of loyalty to us for acts or omissions not in good faith or involving
intentional misconduct, for knowing violation of law, for actions leading to
improper personal benefit to the director, and for payment of dividends or
approval of stock repurchases or redemptions that are unlawful under Delaware
law. The provision also does not affect a director's responsibilities under any
other law, such as federal securities laws or state or federal environmental
laws.
We have entered into indemnity agreements with each of our directors and
executive officers. Such indemnity agreements contain provisions that are in
some respects broader than the specific indemnification provisions contained in
Delaware law.
The foregoing summaries are necessarily subject to the complete text of the
statute, the Certificate of Incorporation, the Bylaws and agreements referred
to above and are qualified in their entirety by reference thereto.
Reference is made to the form of Note and Warrant Purchase Agreements
included below as Exhibits 10.9 and 10.11 for provisions regarding
indemnification of our officers, directors and controlling persons against
liabilities, including liabilities under the Securities Act.
II-1
<PAGE>
ITEM 16. EXHIBITS
<TABLE>
<CAPTION>
Exhibit No. Description
----------- -----------
<C> <S>
2.1 Distribution Agreement between the Company and Medstone
International Inc.(1)
2.2 Asset Purchase Agreement, dated as of February 28, 1998, UroGen
and Baxter Healthcare Corporation(2)
2.3 Amendment to Asset Purchase Agreement, dated as of May 27, 1998,
between UroGen and Baxter(2)
3.1 Certificate of Incorporation of the Company(1)
3.2 Bylaws of the Company(1)
3.3 Certificate of Designation of Preferences and Rights of Series A
Preferred Stock of UroGen(2)
3.4 Certificate of Designation of Preferences and Rights of Series B
Preferred Stock of UroGen(2)
3.5 Certificate of Designation of Preferences and Rights of Series C
Preferred Stock of UroGen(2)
3.6 Certificate of Amendment of the Restated Certificate of
Incorporation(4)
5.1 Opinion of Luce, Forward, Hamilton & Scripps LLP regarding the
legality of securities being registered
10.1 Contribution Agreement between the Company and Medstone
International, Inc. dated October 31, 1995(1)
10.2 Form of Indemnification Agreement(1)
10.3 UroGen Corp. 1995 Stock Plan(1)
10.4 UroGen Corp. 1995 Director Option Plan(1)
10.5 License Agreement, dated March 5, 1997, between UroGen and The
Immune Response Corporation(3)
10.6 Amendment to License Agreement, dated January 29, 1999, between
UroGen and The Immune Response Corporation(3)
10.7 License Agreement, dated November 5, 1997, by and among UroGen,
Sidney Kimmel Cancer Center and Daniel A. Mercola, M.D., Ph.D.(3)
10.8 License Agreement, dated September 20, 1996 between UroGen and The
Regents of the University of California(3)
10.9 Form of Note and Warrant Purchase Agreement, dated July 8, 1998
between UroGen and various investors(3)
10.10 Warrant Certificate, dated July 31, 1997, between UroGen and
Robert E. Sobol(3)
10.11 Distribution Agreement, dated July 8, 1998, by and among UroGen
and Baxter(2)
10.12 Investor Rights Agreement, dated July 8, 1998, between UroGen and
Baxter(2)
10.13 Developmental Collaboration Agreement, dated July 8, 1998 between
UroGen and Baxter(2)
10.14 Credit Agreement, dated July 8, 1998, between UroGen and Baxter(2)
10.15 Technology License Agreement, dated July 8, 1998, between UroGen
and Baxter(2)
10.16 Form of Note and Warrant Purchase Agreement, dated April 28, 1999
between UroGen and various investors(3)
10.17 UroGen Corp. 1999 Stock Plan(5)
10.18 Form of Common Stock and Warrant Purchase Agreement dated January
21, 2000 between UroGen and various investors(5)
10.19 Form of Common Stock Purchase Agreement dated January 21, 2000
between UroGen and various investors(5)
</TABLE>
II-2
<PAGE>
<TABLE>
<C> <S>
10.20 Form of Common Stock Purchase Agreement dated February 22, 2000 between
UroGen and various investors(4)
10.21 Acquisition Agreement and Plan of Merger by and among GenStar
Therapeutics Corporation and Allegro Cell Systems, Inc. dated May 15,
2000
10.22 Registration Rights Agreement dated May 15, 2000
10.23 License Agreement between Allegro Cell Systems, Inc. and The Regents of
the University of California dated May 8, 2000
23.1 Consent of Ernst & Young LLP, Independent Auditors
23.2 Consent of Luce, Forward, Hamilton & Scripps (in the opinion filed as
Exhibit 5.1 hereto)
24.1 Power of Attorney (contained on page II-5 hereto)
27 Financial Data Schedule(4)
</TABLE>
--------
(1) Previously filed with the Company's Application for Registration on Form
10-SB dated February 9, 1996.
(2) Previously filed with the Company's Current Report on Form 8-K dated July
23, 1998.
(3) Previously filed with the Company's Annual Report on Form 10-KSB/A dated
May 24, 1999.
(4) Previously filed with the Company's Annual Report on Form 10-KSB dated
March 30, 2000.
(5) Previously filed with this Registration Statement
ITEM 17. UNDERTAKINGS
(a) The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made,
a post-effective amendment to the 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 this 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 (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a
fundamental change in the information set forth in the Registration
Statement. Notwithstanding the foregoing, any increase or decrease in
volume of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any deviation
from the low or high and of the estimated maximum offering range may be
reflected in the form of prospectus filed with the Commission pursuant
to Rule 424(b) if, in the aggregate, the changes in volume and price
represent no more than 20 percent change in the maximum aggregate
offering price, set forth in the "Calculation of Registration Fee"
table in the effective registration statement; and
(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.
(2) That, for the purpose of determining any liability under the Act,
each such 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.
II-3
<PAGE>
(3) To file a post-effective amendment to remove from registration any
of the securities that remain unsold at the end of the offering.
(b) Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to directors, officers and controlling persons of
the Registrant pursuant to the foregoing provisions, or otherwise, the
Registrant has been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the
Act and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
Registrant of expenses incurred or paid by a director, officer or controlling
person of the Registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person in
connection with the securities being registered, the Registrant will, unless in
the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
II-4
<PAGE>
SIGNATURES
In accordance with 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 authorized this
Registration Statement to be signed on its behalf by the undersigned, in the
City of San Diego, State of California, on the 14th day of November 2000.
Genstar Therapeutics Corporation
/s/ *
By: _________________________________
Chief Executive Officer and
Director
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears
below appoints Paul D. Quadros, Robert E. Sobol and Carin D. Sandvik, and each
of them his/her true and lawful attorneys-in-fact and agent with full power of
substitution and resubstitution, for him/her and in his/her name, place and
stead, in any and all capacities, to sign any and all amendments to this
Registration Statement, including any post-effective amendments as well as any
related registration statement (or amendment thereto) filed in reliance upon
Rule 462(b) under the Securities Act of 1933, and to file the same, with all
exhibits thereto, and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto said attorney-in-fact and
agents, and each of them, full power and authority to do and perform each and
every act and thing requisite or necessary to be done in and about the
premises, as fully to all intents and purposes as he might or could do in
person, hereby ratifying and confirming all that said attorney-in-fact and
agents or any of them, or their or his substitute or substitutes, 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>
Name Title Date
---- ----- ----
<S> <C> <C>
/s/ * Chairman of the Board, November 14, 2000
______________________________________ Chief Financial Officer
and Director (Principal
Financial Officer)
/s/ * Chief Executive Officer November 14, 2000
______________________________________ and Director
/s/ * President November 14, 2000
______________________________________
/s/ * Senior Vice President, November 14, 2000
______________________________________ Chief Scientific Officer
and Director
/s/ Carin D. Sandvik Corporate Controller and November 14, 2000
______________________________________ Corporate Secretary
(Principal Accounting
Officer)
/s/ * Director November 14, 2000
______________________________________
</TABLE>
II-5
<PAGE>
<TABLE>
<CAPTION>
Name Title Date
---- ----- ----
<S> <C> <C>
/s/ * Director November 14, 2000
______________________________________
/s/ * Director November 14, 2000
______________________________________
*By: /s/ Carin D. Sandvik
______________________________________
Carin D. Sandvik
Attorney-in-Fact
</TABLE>
II-6
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibit No. Description
----------- -----------
<C> <S>
2.1 Distribution Agreement between the Company and Medstone
International Inc.(1)
2.2 Asset Purchase Agreement, dated as of February 28, 1998, UroGen
and Baxter Healthcare Corporation(2)
2.3 Amendment to Asset Purchase Agreement, dated as of May 27, 1998,
between UroGen and Baxter(2)
3.1 Certificate of Incorporation of the Company(1)
3.2 Bylaws of the Company(1)
3.3 Certificate of Designation of Preferences and Rights of Series A
Preferred Stock of UroGen(2)
3.4 Certificate of Designation of Preferences and Rights of Series B
Preferred Stock of UroGen(2)
3.5 Certificate of Designation of Preferences and Rights of Series C
Preferred Stock of UroGen(2)
3.6 Certificate of Amendment of the Restated Certificate of
Incorporation(4)
5.1 Opinion of Luce, Forward, Hamilton & Scripps LLP regarding the
legality of securities being registered
10.1 Contribution Agreement between the Company and Medstone
International, Inc. dated October 31, 1995(1)
10.2 Form of Indemnification Agreement(1)
10.3 UroGen Corp. 1995 Stock Plan(1)
10.4 UroGen Corp. 1995 Director Option Plan(1)
10.5 License Agreement, dated March 5, 1997, between UroGen and The
Immune Response Corporation(3)
10.6 Amendment to License Agreement, dated January 29, 1999, between
UroGen and The Immune Response Corporation(3)
10.7 License Agreement, dated November 5, 1997, by and among UroGen,
Sidney Kimmel Cancer Center and Daniel A. Mercola, M.D., Ph.D.(3)
10.8 License Agreement, dated September 20, 1996 between UroGen and The
Regents of the University of California(3)
10.9 Form of Note and Warrant Purchase Agreement, dated July 8, 1998
between UroGen and various investors(3)
10.10 Warrant Certificate, dated July 31, 1997, between UroGen and
Robert E. Sobol(3)
10.11 Distribution Agreement, dated July 8, 1998, by and among UroGen
and Baxter(2)
10.12 Investor Rights Agreement, dated July 8, 1998, between UroGen and
Baxter(2)
10.13 Developmental Collaboration Agreement, dated July 8, 1998 between
UroGen and Baxter(2)
10.14 Credit Agreement, dated July 8, 1998, between UroGen and Baxter(2)
10.15 Technology License Agreement, dated July 8, 1998, between UroGen
and Baxter(2)
10.16 Form of Note and Warrant Purchase Agreement, dated April 28, 1999
between UroGen and various investors(3)
10.17 UroGen Corp. 1999 Stock Plan(5)
10.18 Form of Common Stock and Warrant Purchase Agreement dated January
21, 2000 between UroGen and various investors(5)
10.19 Form of Common Stock Purchase Agreement dated January 21, 2000
between UroGen and various investors(5)
</TABLE>
<PAGE>
<TABLE>
<C> <S>
10.20 Form of Common Stock Purchase Agreement dated February 22, 2000 between
UroGen and various investors(4)
10.21 Acquisition Agreement and Plan of Merger by and among GenStar
Therapeutics Corporation and Allegro Cell Systems, Inc. dated May 15,
2000
10.22 Registration Rights Agreement dated May 15, 2000
10.23 License Agreement between Allegro Cell Systems, Inc. and The Regents of
the University of California dated May 8, 2000
23.1 Consent of Ernst & Young LLP, Independent Auditors
23.2 Consent of Luce, Forward, Hamilton & Scripps (in the opinion filed as
Exhibit 5.1 hereto)
24.1 Power of Attorney (contained on page II-5 hereto)
27 Financial Data Schedule(4)
</TABLE>
--------
(1) Previously filed with the Company's Application for Registration on Form
10-SB dated February 9, 1996.
(2) Previously filed with the Company's Current Report on Form 8-K dated July
23, 1998.
(3) Previously filed with the Company's Annual Report on Form 10-KSB/A dated
May 24, 1999.
(4) Previously filed with the Company's Annual Report on Form 10-KSB dated
March 30, 2000.
(5) Previously filed with this Registration Statement
