Registration No. 333-
As filed with the Securities and Exchange Commission on March 10, 1997
- --------------------------------------------------------------------------------
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
ARONEX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware 76-0196535
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
3400 Research Forest Drive
The Woodlands, Texas 77381
(281) 367-1666
(Address, including zip code, and telephone number,
including area code, of registrant's principal executive offices)
James M. Chubb, Ph.D.
President
Aronex Pharmaceuticals, Inc.
3400 Research Forest Drive
The Woodlands, Texas 77381
(281) 367-1666
(Name, address and telephone number, including area code, of agent for service)
With copies to:
Andrews & Kurth L.L.P.
2170 Buckthorne Place, Suite 150
The Woodlands, Texas 77380
(713) 220-4801
Attn.: Jeffrey L. Wade
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO PUBLIC: As soon
as practicable after the 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 only in connection with
dividend or interest reinvestment plans, please check the following box. /x/
If this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration 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 is expected to be made
pursuant to Rule 434, please check the following box. |_|
CALCULATION OF REGISTRATION FEE
Proposed Maximum Proposed
Title of Each Class of Shares Offering Maximum Aggregate Amount of
Securities to be Registered to be Registered Price Per Share (1) Offering Price (1) Registration Fee (1)
Common Stock, par value $.001
per share........................ 570,273 $8.00 $4,562,184 $1,383
(1) Pursuant to Rule 457(c), the registration fee is calculated based upon the
average of the high and low sale prices for the Common Stock reported by
the Nasdaq National Market on March 4, 1997.
-----------
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.
[LOGO AND NAME OF
ARONEX PHARMACEUTICALS, INC.]
570,273 Shares of
Common Stock
This prospectus relates to the offering of up to 570,273 shares (the
"Shares") of the Common Stock, par value $.001 per share ("Common Stock"), of
Aronex Pharmaceuticals, Inc., a Delaware corporation ("Aronex" or the
"Company"), by the selling stockholders named herein (the "Selling
Stockholders"). The Common Stock is quoted on the Nasdaq National Market under
the trading symbol "ARNX". On March 6, 1997, the last reported sale price of the
Common Stock on the Nasdaq National Market was $7.75 per share.
All or part of the Shares may be offered by the Selling Stockholders
from time to time for their own account in transactions on The Nasdaq National
Market, in negotiated transactions or otherwise at market prices prevailing at
the time of sale, at prices related to such prevailing market prices or at
negotiated prices. The Selling Stockholders may effect such transactions by
selling the Shares to or through broker-dealers and such broker-dealers may
receive compensation in the form of discounts, concessions or commission from
the Selling Stockholders or the purchasers of the Shares for whom such
broker-dealers may act as agent or to whom they sell as principal or both (which
compensation to a particular broker-dealer might be in excess of customary
commissions).
None of the proceeds from the sale of the Shares by the Selling
Stockholders will be received by the Company. The Company has agreed to bear
certain expenses in connection with the registration and sale of the Shares
being offered by the Selling Stockholders. The Selling Stockholders and any
broker-dealers participating in the distribution of the Shares may be deemed to
be "underwriters" within the meaning of the Securities Act of 1933, as amended
(the "Securities Act").
The Shares have not been registered for sale by the Selling
Stockholders under the securities laws of any state as of the date of this
Prospectus. Brokers or dealers effecting transactions in the Shares should
confirm registration thereof under the securities laws of the states in which
such transactions occur, or the existence of any exemption from registration.
THE COMMON STOCK OFFERED HEREBY INVOLVES A HIGH DEGREE OF RISK.
SEE "RISK FACTORS" WHICH BEGINS ON PAGE 5 OF THIS PROSPECTUS.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES
COMMISSION NOR HAS THE SECURITIES AND EXCHANGE
COMMISSION OR ANY STATE SECURITIES COMMISSION
PASSED UPON THE ACCURACY OR ADEQUACY OF
THIS PROSPECTUS. ANY REPRESENTATION TO
THE CONTRARY IS A CRIMINAL OFFENSE.
------------------------------------
The date of this Prospectus is March 10, 1997
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), and,
accordingly, files reports, proxy statements and other information with the
Securities and Exchange Commission (the "SEC"). Such reports, proxy statements
and other information filed with the SEC are available for inspection and
copying at the public reference facilities maintained by the SEC at Room 1024,
Judiciary Plaza, 450 Fifth Street, N.W., Washington, DC 20549, and at the SEC's
Regional Offices located at Citicorp Center, 500 West Madison Street, Suite
1400, Chicago, Illinois 60661 and at Seven World Trade Center, Suite 1300, New
York, New York 10048. Copies of such documents may also be obtained from the
Public Reference Section of the SEC at Judiciary Plaza, 450 Fifth Street, N.W.,
Washington, DC 20549, at prescribed rates. The SEC maintains a site on the World
Wide Web at http://www.sec.gov that contains reports, proxy statements and other
information regarding registrants that file electronically with the SEC. In
addition, such materials and other information concerning the Company can be
inspected at the National Association of Securities Dealers, Inc., 1735 K
Street, N.W., Washington, DC 20006.
The Company has filed with the SEC a registration statement (the
"Registration Statement") under the Securities Act of 1933, as amended (the
"Securities Act"), on Form S-3 with respect to the securities offered hereby.
This Prospectus does not contain all of the information set forth in the
Registration Statement and the exhibits thereto, certain parts of which are
omitted in accordance with the rules and regulations of the SEC. Statements made
in this Prospectus as to the contents of any contract, agreement or other
document referred to are not necessarily complete. With respect to each such
contract, agreement or other document filed as an exhibit to the Registration
Statement, reference is made to the exhibit for a more complete description of
the matter involved. The Registration Statement and any amendments thereto,
including exhibits filed or incorporated by reference as a part thereof, are
available for inspection and copying at the SEC's offices as described above.
DOCUMENTS INCORPORATED BY REFERENCE
The following documents, which have been filed by the Company with the
SEC, are incorporated by reference into this Prospectus:
1. The Annual Report on Form 10-K for the fiscal year ended
December 31, 1995, as amended; and
2. The Quarterly Report on Form 10-Q for the quarterly period
ended March 31, 1996;
3. The Quarterly Report on Form 10-Q for the quarterly period
ended June 30, 1996;
4. The Quarterly Report on Form 10-Q for the quarterly period
ended September 30, 1996; and
5. The description of the Common Stock contained in the
Company's Registration Statement on Form 8-A filed April 23,
1992, including any amendments and reports filed for the
purpose of updating such description.
All reports and documents filed by the Company pursuant to Section
13(a), 13(c), 14 or 15(d) of the Exchange Act, prior to the filing of a
post-effective amendment which indicates that all securities offered hereby have
been sold or which deregisters all securities then remaining unsold, shall be
deemed to be incorporated by reference herein and to be a part hereof from the
respective date of filing of such documents. Any statement contained herein or
in a document all or a portion of which is incorporated or deemed to be
incorporated by reference herein shall be deemed to be modified or superseded
for purposes of this Prospectus to the extent that a statement contained herein
or in any other subsequently filed document that also is or is deemed to be
incorporated by reference herein modifies or supersedes such statement. Any such
statement so modified or superseded shall not be deemed, except as so modified
or superseded, to constitute a part of this Prospectus.
THIS PROSPECTUS INCORPORATES DOCUMENTS BY REFERENCE WHICH ARE NOT
PRESENTED HEREIN OR DELIVERED HEREWITH. THE COMPANY HEREBY UNDERTAKES TO PROVIDE
WITHOUT CHARGE TO EACH PERSON, INCLUDING ANY BENEFICIAL
-2-
OWNER, TO WHOM A COPY OF THIS PROSPECTUS HAS BEEN DELIVERED, ON THE WRITTEN OR
ORAL REQUEST OF ANY SUCH PERSON, A COPY OF ANY AND ALL OF THE DOCUMENTS REFERRED
TO ABOVE WHICH HAVE BEEN OR MAY BE INCORPORATED IN THIS PROSPECTUS BY REFERENCE,
OTHER THAN EXHIBITS TO SUCH DOCUMENTS (UNLESS SUCH EXHIBITS ARE SPECIFICALLY
INCORPORATED BY REFERENCE INTO SUCH DOCUMENTS). SUCH REQUESTS FOR DOCUMENTS
SHOULD BE DIRECTED TO ARONEX PHARMACEUTICALS, INC., 3400 RESEARCH FOREST DRIVE,
THE WOODLANDS, TEXAS 77381, ATTENTION: INVESTOR RELATIONS, TELEPHONE NUMBER
(281) 367-1666.
No person is authorized to give any information or to make any
representation not contained in this Prospectus, and, if given or made, such
information or representation must not be relied upon as having been authorized.
This Prospectus does not constitute an offer to sell, or a solicitation of an
offer to purchase, any of the securities offered by this Prospectus, or the
solicitation of a proxy, in any jurisdiction in which, or to any person to whom,
it is unlawful to make such offer or solicitation of an offer or proxy
solicitation. Neither the delivery of this Prospectus nor any distribution of
the securities offered hereby shall, under any circumstances, create any
implication that the information contained herein is correct as of any time
subsequent to the date hereof or that there has been no change in the affairs of
the Company since the date hereof.
--------------------------------------------
-3-
THE COMPANY
The following is qualified in its entirety by the more detailed
information appearing elsewhere in this Prospectus, and by the more detailed
information and financial statements, including notes thereto, included in the
Company's Annual Report on Form 10-K for the year ended December 31, 1995, as
amended, and in subsequent reports filed pursuant to Section 13 or 15(d) of the
Exchange Act, which are incorporated by reference herein.
Aronex is a leading biopharmaceutical company engaged in the discovery
and development of proprietary innovative medicines to treat cancer and
life-threatening infectious diseases. The Company's strategy is to discover and
develop medicines based upon either refinements of proven therapies or novel
mechanisms of action against specific disease targets. The Company has a
portfolio of clinical and preclinical products that it believes provides a
balanced development and commercialization risk profile. The Company believes
its focus on medicines for cancer and life-threatening infectious diseases for
which current therapy is inadequate will provide synergies in research,
development and product marketing, and will facilitate expedited
commercialization of its products.
Aronex currently has four products in various stages of ongoing
clinical development and a number of products in preclinical development. In
addition, the Company has proprietary technologies in drug discovery and drug
formulation that should continue to provide a significant research and
development pipeline. The Company's four products in ongoing clinical
development are listed below:
Clinical
Product Indications Status
NyotranTM Systemic Fungal Infections Phase III
AtragenTM Acute Promyelocytic Leukemia Phase II
Kaposi's Sarcoma (a skin cancer) Phase II/III
Annamycin Breast Cancer Phase I/II
ZintevirTM HIV Infection Phase I
The Company has strategic alliances and collaboration arrangements with
leading corporations and academic institutions, including alliances with
Boehringer Mannheim GmbH ("Boehringer Mannheim") and Genzyme Corporation
("Genzyme") and a collaboration with The University of Texas M.D. Anderson
Cancer Center ("MD Anderson").
The Company was incorporated in 1986 as Argus Pharmaceuticals, Inc.
("Argus"). Argus acquired Oncologix, Inc. ("Oncologix") and Triplex
Pharmaceutical Corporation ("Triplex") through a three-way merger (the
"Mergers") in September 1995, at which time Argus changed its name to Aronex
Pharmaceuticals, Inc. The merger of these three complementary companies
established an integrated company with the following characteristics: (i) a
clear therapeutic focus in cancer and life-threatening infectious diseases; (ii)
a well-defined and diverse portfolio of products at various stages of clinical
and preclinical development; (iii) a broad-based platform of synergistic
technologies and scientific expertise; (iv) a diverse group of corporate
partners and academic affiliations; and (v) an experienced team of scientific
and biopharmaceutical personnel who possess the ability to discover and develop
novel products, design and implement complex clinical trials, manage regulatory
issues, develop manufacturing processes and implement the commercialization of
products. Unless the context otherwise requires, references in this Prospectus
to "Aronex" and the "Company" refer to Aronex and its subsidiaries.
The Company's corporate headquarters is located at 3400 Research Forest
Drive, The Woodlands, Texas 77381, and its telephone number is (281) 367-1666.
-4-
RISK FACTORS
In evaluating the Company and its business, prospective investors
should consider carefully the following risk factors, together with the
information and financial data set forth in the reports and documents
incorporated by reference herein, prior to purchasing any shares of Common Stock
offered hereby.
Early Stage of Development; History of Operating Losses; Anticipation
of Future Losses. The Company is a development stage company. It has generated
no revenues from product sales, and it does not expect to generate revenue from
product sales for several years. As of September 30, 1996, the Company's
accumulated deficit was $50.6 million. To date, the Company has dedicated most
of its financial resources to the research and development of products, general
and administrative expenses, and the prosecution of patents and patent
applications. The Company expects to incur significant and increasing operating
losses for at least the next several years, primarily due to the expansion of
its research and development programs, including preclinical studies and
clinical trials, and costs associated with the commercialization of its products
if regulatory approvals are received. The Company's ability to achieve
profitability will depend, among other things, on successfully completing
development of its products, obtaining regulatory approvals, establishing
manufacturing, sales and marketing capabilities or collaborative arrangements,
and raising sufficient funds to finance its activities. There can be no
assurance that the Company will be able to achieve profitability or that
profitability, if achieved, can be sustained.
Future Capital Needs; Uncertainty of Additional Funding. The Company
has experienced negative cash flows from operations since its inception and has
funded its activities to date primarily from equity financings. The Company has
expended, and will continue to require, substantial funds to continue research
and development, including preclinical studies and clinical trials of its
products, and to commence sales and marketing efforts if United States Food and
Drug Administration (the "FDA") and other regulatory approvals are obtained. The
Company expects that its existing capital resources will be sufficient to fund
its capital requirements through mid-1998. Thereafter, the Company will need to
raise substantial additional capital to fund its operations. The Company's
capital requirements will depend on many factors, including the problems,
delays, expenses and complications frequently encountered by development stage
companies; the progress of the Company's research, development and clinical
trial programs; the extent and terms of any future collaborative research,
manufacturing, marketing or other funding arrangements; the costs and timing of
seeking regulatory approvals of the Company's products; the Company's ability to
obtain regulatory approvals; the success of the Company's sales and marketing
programs; costs of filing, prosecuting and defending and enforcing any patent
claims and other intellectual property rights; and changes in economic,
regulatory or competitive conditions or the Company's planned business.
Estimates about the adequacy of funding for the Company's activities are based
on certain assumptions, including the assumption that testing and regulatory
procedures relating to the Company's products can be conducted at projected
costs. There can be no assurance that changes in the Company's research and
development plans, acquisitions, or other events will not result in accelerated
or unexpected expenditures. To satisfy its capital requirements, the Company may
seek to raise additional funds in the public or private capital markets. The
Company's ability to raise additional funds in the public or private markets
will be adversely affected if the results of its current or future clinical
trials are not favorable. The Company may seek additional funding through
corporate collaborations and other financing vehicles. There can be no assurance
that any such funding will be available to the Company on favorable terms or at
all. If adequate funds are not available, the Company may be required to curtail
significantly one or more of its research or development programs, or it may be
required to obtain funds through arrangements with future collaborative partners
or others that may require the Company to relinquish rights to some or all of
its technologies or products. If the Company is successful in obtaining
additional financing, the terms of such financing may have the effect of
diluting or adversely affecting the holdings or the rights of the holders of the
Company's Common Stock.
-5-
Uncertainties Related to Clinical Trial Results. The FDA and other
regulatory authorities generally require that the safety and efficacy of a drug
be supported by results from adequate and well-controlled Phase III clinical
trials before approval for commercial sale. The Company has limited experience
in conducting and managing Phase III clinical trials. If the results of the
Company's clinical trials do not demonstrate the safety and efficacy of its
products in the treatment of patients suffering from the diseases for which such
products are being tested, the Company will not be able to submit a New Drug
Application ("NDA") to the FDA. Clinical trials conducted on a fast-track, or
expedited, basis may carry a higher risk that data will not be favorable or that
the FDA will not accept the NDA for submission than do Phase III clinical trials
developed from earlier clinical trials with large populations using similar
protocols. Even if the Company believes the Phase III clinical trials
demonstrate the safety and efficacy of a product in the treatment of disease,
the FDA and other regulatory authorities may not accept the Company's assessment
of the results. In either case, the Company may have to conduct additional
clinical trials in an effort to demonstrate the safety and efficacy of the
product. Without acceptable results and regulatory approval, the Company will
not be able to commercialize its products, which would have a material adverse
effect on the Company. There can be no assurance that the results of any of the
Company's clinical trials will be favorable or that its products will obtain
regulatory approval for commercialization.
The results of preclinical studies and initial clinical trials of the
Company's products are not necessarily predictive of the results from
large-scale clinical trials. The Company must demonstrate through preclinical
studies and clinical trials that its products are safe and effective for use in
each target indication before the Company can obtain regulatory approvals for
the commercial sale of those products. These studies and trials may be very
costly and time-consuming. The speed with which the Company is able to enroll
patients in clinical trials is an important factor in determining how quickly
clinical trials may be completed. Many factors affect patient enrollment,
including the size of the patient population, the proximity of patients to
clinical sites, and the eligibility criteria for the study. A number of the
Company's clinical trial protocols are targeted at indications that have small
patient populations, which may make it difficult for the Company to enroll
enough patients to complete the trials. Delays in patient enrollment in the
trials may result in increased costs, program delays, or both, which could have
a material adverse effect on the Company. Even if the Company establishes the
safety and efficacy of its products and obtains FDA and other regulatory
approvals for its products, physicians may not prescribe the approved product.
The administration of any product the Company develops may produce
undesirable side effects in humans. The occurrence of side effects could
interrupt or delay clinical trials of products and could result in the FDA's or
other regulatory authorities' denying approval of the Company's products for any
or all targeted indications. The Company, the FDA or other regulatory
authorities may suspend or terminate clinical trials at any time. Even if the
Company receives FDA and other regulatory approvals, the Company's products may
later exhibit adverse effects that limit or prevent their widespread use or that
necessitate their withdrawal from the market. There can be no assurance that any
of the Company's products will be safe for human use.
Government Regulation; No Assurances of Regulatory Approval. The
Company's research and development activities, preclinical studies, clinical
trials, and the manufacturing and marketing of its products are subject to
extensive regulation by the FDA and other regulatory authorities in the United
States. These activities are also regulated in other countries where the Company
intends to test and market its products.
Before marketing, any drug developed by the Company must undergo an
extensive regulatory approval process. The regulatory process, which includes
preclinical studies and clinical trials of each compound to establish its safety
and efficacy, takes many years and requires the expenditure of substantial
resources. Data obtained from preclinical and clinical activities are
susceptible to varying interpretations which could delay, limit or prevent FDA
regulatory approval. Although the FDA may have been consulted in developing
protocols for clinical trials, that consultation provides no assurance that the
FDA will accept the clinical trials as adequate or well-controlled or accept the
results of those trials. Similarly, the FDA may determine that products are not
eligible for or will not receive expedited review, whether or not the FDA has
previously indicated that such products may be eligible for expedited review. In
addition, delays or rejections may be encountered based upon changes in FDA
policy for drug approval during the period of product development and FDA
regulatory review of each submitted NDA. Similar delays and rejections may also
be encountered in foreign countries. There can be no assurance that, even after
such time and expenditures, regulatory approval will be obtained for any drugs
developed by the Company. Moreover, if regulatory approval of a drug is granted,
such approval may entail
-6-
limitations on the indicated uses for which it may be marketed. Further, even if
such regulatory approval is obtained, a marketed drug, its manufacturer and its
manufacturing facilities are subject to continual review and periodic
inspections, and later discovery of previously unknown problems with a product,
manufacturer or facility may result in restrictions on the product or
manufacturers, including a withdrawal of the product from the market. Failure to
comply with the applicable regulatory requirements can, among other things,
result in fines, suspensions of regulatory approvals, product recalls, operating
restrictions and criminal prosecution. Further, additional government regulation
may be established that could prevent or delay regulatory approval of the
Company's products. A bill proposing comprehensive reform of FDA regulations has
been introduced in the United States Senate. This bill addresses many facets of
FDA regulations, including requirements for NDA approval, requirements for
supplemental approval, off-label information dissemination, and export
regulations. A counterpart bill is expected to be introduced into the United
States House of Representatives. It is not certain whether any such legislation
will be enacted into law, what form any law will take, or what effect any new
law would have on the Company.
The Company's business is also subject to regulation under state and
federal laws regarding environmental protection, hazardous substances control,
and exposure to blood-borne pathogens. These laws include the Occupational
Safety and Health Act, the Environmental Protection Act, and the Toxic Substance
Control Act. Any violation of, and the cost of compliance with, these laws and
regulations could adversely affect the Company. There can be no assurance that
statutes or regulations applicable to the Company's business will not be adopted
that impose substantial additional costs or otherwise materially adversely
affect the Company's operations.
Uncertainty of Protection for Patents and Proprietary Technology. The
Company's ability to commercialize any products will depend, in part, upon its
or its licensors' ability to obtain patents, enforce those patents, preserve
trade secrets, and operate without infringing upon the proprietary rights of
third parties. The patent positions of biotechnology and pharmaceutical
companies are highly uncertain and involve complex legal and factual questions.
Some of the United States patents and patent applications owned by or licensed
to the Company are method-of-use patents that cover the use of certain compounds
to treat specified conditions, and composition-of-matter patents are not
available for some of the Company's product candidates. The Company does not
have any patents or patent applications with respect to one of its products,
AR102. There can be no assurance that the patent applications licensed to or
owned by the Company will result in issued patents, that patent protection will
be secured for any particular technology, that any patents that have been or may
be issued to the Company or its licensors will be valid or enforceable, that any
patents will provide meaningful protection to the Company, that others will not
be able to design around the patents, or that the Company's patents will provide
a competitive advantage or have commercial application.
There can be no assurance that patents owned by or licensed to the
Company will not be challenged by others. The Company could incur substantial
costs in proceedings before the United States Patent Office and other regulatory
authorities, including interference proceedings. These proceedings could result
in adverse decisions about the patentability of the Company's inventions and
products as well as about the enforceability, validity or scope of protection
afforded by the patents. The Company is currently involved in an interference
proceeding before the United States Patent Office regarding AR726.
There can be no assurance that the manufacture, use or sale of the
Company's products will not infringe patent rights of others. The Company may be
unable to avoid infringement of those patents and may have to seek a license,
defend an infringement action, or challenge the validity of the patents in
court. There can be no assurance that a license will be available to the
Company, if at all, upon terms and conditions acceptable to the Company or that
the Company will prevail in any patent litigation. Patent litigation is costly
and time consuming, and there can be no assurance that the Company will have
sufficient resources to bring such litigation to a successful conclusion. If the
Company does not obtain a license under such patents, is found liable for
infringement, or is not able to have such patents declared invalid, the Company
may be liable for significant damages, may encounter significant delays in
bringing products to market, or may be precluded from participating in the
manufacture, use or sale of products or methods of treatment requiring such
licenses. There can be no assurance that the Company has identified United
States and foreign patents that pose a risk of infringement.
-7-
The Company also relies upon trade secrets and other unpatented
proprietary information in its product development activities. To the extent the
Company relies on trade secrets and unpatented know-how to maintain its
competitive technological position, there can be no assurance that others may
not independently develop the same or similar technologies. The Company seeks to
protect trade secrets and proprietary knowledge, in part through confidentiality
agreements with its employees, consultants, advisors and collaborators.
Nevertheless, these agreements may not effectively prevent disclosure of the
Company's confidential information and may not provide the Company with an
adequate remedy in the event of unauthorized disclosure of such information. If
the Company's employees, scientific consultants or collaborators develop
inventions or processes independently that may be applicable to the Company's
products, disputes may arise about ownership of proprietary rights to those
inventions and processes. Such inventions and processes will not necessarily
become the Company's property, but may remain the property of those persons or
their employers. Protracted and costly litigation could be necessary to enforce
and determine the scope of the Company's proprietary rights. Failure to obtain
or maintain patent and trade secret protection, for any reason, would have a
material adverse effect on the Company.
The Company engages in collaborations, sponsored research agreements,
licensing and other arrangements with academic researchers and institutions that
have received and may receive funding from United States government agencies. As
a result of these arrangements, the United States government or certain third
parties have rights in certain inventions developed during the course of the
performance of such collaborations and agreements as required by law or such
agreements.
Several bills affecting patent rights have been introduced in the
United States Congress. These bills address various aspects of patent law,
including publication, patent term, re-examination, subject matter and
enforceability. It is not certain whether any of these bills will be enacted
into law or what form new laws may take. Accordingly, the effect of legislative
change on the Company's intellectual property estate is uncertain.
Manufacturing Uncertainties; Reliance on Third-Party Suppliers. The
Company does not operate and does not currently plan to operate manufacturing
facilities for the production of its products in commercial quantities, and it
intends to contract with third parties for the manufacture and supply of its
products. There can be no assurance that the Company will be able to obtain
supplies of its products from third-party suppliers on terms or in quantities
acceptable to the Company. Also, the Company's dependence on third parties for
the manufacture of its products may adversely affect the Company's product
margins and its ability to develop and deliver products on a timely basis. Any
such third-party suppliers or any manufacturing facility the Company establishes
will be required to meet FDA manufacturing requirements. FDA certification of
manufacturing facilities for a drug is a prerequisite to approval of an NDA for
that drug. The Company may encounter significant delays in obtaining supplies
from third-party manufacturers or experience interruptions in its supplies. If
the Company is unable to obtain adequate supplies, its business would be
materially adversely affected.
Lack of Sales and Marketing Experience. The Company does not have any
experience in sales, marketing or distribution. To market any of its products,
the Company must develop a sales and marketing force with supporting
distribution capability or enter into marketing and distribution arrangements
with a company that has an established capability. Significant additional
expenditures will be required for the Company to develop such capabilities. The
Company has entered into license agreements with Boehringer Mannheim with
respect to AR209 and with Genzyme with respect to AtragenTM, and it plans to
enter into marketing agreements with one or more other pharmaceutical companies
to market other products that it may develop. To the extent the Company relies
upon licensing, marketing or distribution arrangements with others, any revenues
the Company receives will depend upon the efforts of third parties. There can be
no assurance that any third party will market the Company's products
successfully or that any third-party collaboration will be on terms favorable to
the Company. If any marketing partner does not market a product successfully,
the Company's business would be materially adversely affected. There can be no
assurance that the Company will be able to establish sales, marketing and
distribution capabilities or that it or its collaborators will be successful in
gaining market acceptance for any products that the Company may develop. The
Company's failure to establish marketing capabilities or to enter into marketing
arrangements with third parties would have a material adverse effect on the
Company.
-8-
Risks Associated with Collaborative Arrangements. The Company's product
development and commercialization strategy involves the Company entering into
various arrangements with corporate, government and academic collaborators,
licensors, licensees and others. As a consequence, the Company's success may
depend on the success of these other parties in performing their
responsibilities. There can be no assurance that the Company will be able to
establish additional collaborative arrangements or license agreements that are
necessary or desirable for the Company to develop and commercialize its products
or that any such collaborative agreement or license agreement will be
successful. Some of the Company's collaborative agreements and license
agreements provide for milestone payments to the Company, and others require the
Company to pay milestone payments to others. No assurance can be given that the
Company will achieve the milestones that trigger payments to the Company, nor
can assurance be given that payments by the Company will result in the
development of marketable products. No assurance can be given that any current
or future collaborative arrangement will be renewed at the end of its term or
will be renewed on terms as favorable to the Company as its original terms.
Competition and Technological Change. The Company is engaged in
pharmaceutical product development characterized by extensive research efforts
and rapid technological progress. Many established biotechnology and
pharmaceutical companies, universities and other research institutions with
resources significantly greater than the Company's may develop products that
directly compete with the Company's products. Those entities may succeed in
developing products, including liposomes and lipid-based products, that are
safer, more effective or less costly than the Company's products. Even if the
Company's products should prove to be more effective than those developed by
other companies, other companies may be more successful than the Company because
of greater financial resources, greater experience in conducting preclinical and
clinical trials and obtaining regulatory approval, stronger sales and marketing
efforts, earlier receipt of approval for competing products and other factors.
If the Company commences significant commercial sales of its products, it or its
collaborators will compete in areas in which the Company has little or no
experience such as manufacturing and marketing. There can be no assurance that
the Company's products, if commercialized, will be accepted and prescribed by
healthcare professionals.
Some of the Company's competitors are active in the development of
liposome and lipid-based research and product development to treat cancer and
certain fungal infections. Those competitors include SEQUUS Pharmaceuticals,
Inc., NeXstar Pharmaceuticals, Inc. and The Liposome Company, Inc. Some of those
companies' products have regulatory approval in the United States and other
countries. Any marketing of these and other products that treat disease
indications targeted by the Company could adversely affect the market acceptance
of the Company's products as a result of the established market recognition and
physician familiarity with the competing product. The presence of directly
competitive products could also result in more intense price competition than
might otherwise exist, which could have a material adverse effect on the
Company's financial condition and results of operations. The Company believes
that competition will be intense for all of its products.
No Assurance of Adequate Third-Party Reimbursement. The Company's
ability to commercialize its products successfully will depend in part on the
extent to which appropriate reimbursement levels for the cost of the products
and related treatment are obtained from government authorities, private health
insurers and other organizations, such as health maintenance organizations
("HMOs"). Third-party payors are increasingly challenging the prices charged for
medical products and services. Accordingly, if less costly drugs are available,
third-party payors may not authorize reimbursement for the Company's products
even if they offer advantages in safety or efficacy. Also, the trend toward
managed healthcare and government insurance programs could significantly
influence the purchase of healthcare services and products, resulting in lower
prices and reducing demand for the Company's products. The cost containment
measures that healthcare providers are instituting and any healthcare reform
could affect the Company's ability to sell its products and may have a material
adverse effect on the Company.
There can be no assurance that reimbursement in the United States or
foreign countries will be available for any of the Company's products, that any
reimbursement granted will be maintained, or that limits on reimbursement
available from third-party payors will not reduce the demand for, or negatively
affect the price of, the Company's products. The unavailability or inadequacy of
third-party reimbursement for the Company's products would have a material
adverse effect on the Company. The Company is unable to forecast what additional
legislation or regulation relating to the
-9-
healthcare industry or third-party coverage and reimbursement may be enacted in
the future, or what effect the legislation or regulation would have on the
Company's business.
Potential Product Liability; Availability of Insurance. The Company
risks exposure to product liability claims if the use of its products is alleged
to have an adverse effect on subjects or patients. This risk exists for products
tested in human clinical trials as well as products that are sold commercially.
There can be no assurance that product liability claims, if made, would not
result in a recall of the Company's products or a change in the indications for
which they may be used. The Company maintains product liability insurance
coverage for claims arising from the use of its products in clinical trials.
There can be no assurance that this coverage will be adequate to cover claims.
Product liability insurance is becoming increasingly expensive, and no assurance
can be given that the Company will be able to maintain such insurance, obtain
additional insurance, or obtain insurance at a reasonable cost or in sufficient
amounts to protect the Company against losses that could have a material adverse
effect on the Company.
Control by Existing Stockholders. As of March 1, 1997, directors,
executive officers, certain stockholders of the Company who are parties to a
stockholders agreement and their respective affiliates beneficially owned
approximately 34.1% of the Company's outstanding Common Stock. Stockholders
holding 4,834,808 shares (approximately 33.3% of the Company's outstanding
stock) of the Common Stock are parties to a stockholders agreement pursuant to
which they have agreed to vote their shares for the election of directors
designated by certain groups among the parties to such agreement. In addition,
the Company has agreed to nominate for election only those directors designated
by parties to that stockholders agreement. The stockholders agreement terminates
on September 11, 1997. Accordingly, these stockholders, individually and as a
group, may be able to determine the composition of the board of directors and
may be able to influence the outcome of other stockholder votes, including votes
concerning the adoption or amendment of provisions in the Company's Amended and
Restated Certificate of Incorporation (the "Certificate of Incorporation") and
the approval of mergers and other significant corporate transactions. The
existence of these levels of ownership concentrated in a few persons makes it
unlikely that any other holder of Common Stock will be able to affect the
management or direction of the Company. These factors, along with the factors
described in "-- Anti-Takeover Provisions," may also have the effect of delaying
or preventing a change in the management or voting control of the Company. See
"Description of the Company's Securities -- Stockholders Agreement."
Dependence on Key Personnel. The success of the Company depends in
large part on the Company's ability to attract and retain highly qualified
scientific and management personnel. The Company faces competition for such
personnel from other companies, research and academic institutions, government
entities and other organizations. There can be no assurance that the Company
will be successful in hiring or retaining key personnel.
Shares Eligible for Future Sale; Registration Rights. Sales of a
substantial number of shares of Common Stock in the public market following this
offering could adversely affect the market price for the Common Stock. Of the
14,597,247 shares of Common Stock outstanding as of December 31, 1996,
13,617,390 shares are eligible for sale without restriction under the Securities
Act (except for shares held by affiliates of the Company and certain former
affiliates of Triplex and Oncologix whose shares may be sold subject to the
volume limitations and certain other requirements of Rule 144 under the
Securities Act), and 979,857 shares are restricted securities that may not be
resold unless such resale is registered under the Securities Act or it is made
under Rule 144 or another exemption from registration under the Securities Act.
The holders of 5,985,919 shares of Common Stock have agreed not to sell such
shares until March 11, 1997 without the consent of the Company, except under
certain circumstances. Some investors have the right to require the Company to
register the public resale of their shares. Any such sales may have an adverse
effect on the price of the Company's Common Stock and could impair the Company's
ability to raise capital through offerings of equity securities. See
"Description of the Company's Securities -- Registration Rights."
Contingent Stock Rights; Absence of Dividends. Pursuant to the terms
of the mergers in which the Company acquired Triplex and Oncologix, the Company
is obligated to issue shares of Common Stock to certain former securityholders
of Triplex and Oncologix contingent upon the occurrence of certain events. These
rights may result in the issuance of up to an aggregate of $10.1 million of
Common Stock, valued for such purpose at the current market value of
-10-
the Common Stock at the time the event requiring issuance of such shares occurs.
See "Description of the Company's Securities -- Contingent Stock Rights." The
Company does not anticipate paying cash dividends in the foreseeable future.
Limited Trading Volumes; Possible Stock Price Volatility. The
historical trading volume of the Company's Common Stock has been limited. There
can be no assurance that an active public market for the Common Stock will
develop or be sustained. The trading price of the Common Stock and the price at
which the Company may sell securities in the future could be subject to large
fluctuations in response to announcements of research activities, technological
innovations or new products by the Company or its competitors, changes in
government regulations, developments concerning proprietary rights, quarterly
variations in operating results, litigation, clinical trials of products,
approval or denial of NDAs, general market conditions, the liquidity of the
Company and its ability to raise additional funds and other events. The market
price of the Common Stock, and the market prices for securities of emerging
biotechnology companies generally, have experienced extreme fluctuations in
recent years. These fluctuations have sometimes been unrelated to the operating
performance of the affected companies. These market fluctuations as well as
general fluctuations in the stock markets may also affect the price of the
Common Stock.
Anti-Takeover Provisions. The Company's Certificate of Incorporation
(i) provides for staggered terms of office for directors; (ii) requires certain
procedures to be followed and time periods to be met for any stockholder to
propose matters to be considered at annual meetings of stockholders, including
nominating directors for election at those meetings; (iii) prohibits
stockholders from calling special meetings of stockholders; and (iv) authorizes
the Board of Directors of the Company to issue up to 10,000,000 shares of
preferred stock without stockholder approval and to set the rights, preferences
and other designations, including voting rights, of those shares as the Board of
Directors may determine. These provisions, alone or in combination with each
other and with the matters described in "-- Control by Existing Stockholders,"
may discourage transactions involving actual or potential changes of control of
the Company, including transactions that otherwise could involve payment of a
premium over prevailing market prices to holders of Common Stock. The Company
also is subject to provisions of the Delaware General Corporation Law that may
make some business combinations more difficult. See "Description of the
Company's Securities --Certain Provisions of the Company's Charter and Bylaws
and Delaware Law."
Forward-Looking Statements and Associated Risks. This Prospectus
contains forward-looking statements. The words "anticipate," "believe,"
"expect," "estimate," "project" and similar expressions are intended to identify
forward-looking statements. Such statements reflect the Company's current views
with respect to future events and financial performance and are subject to
certain risks, uncertainties and assumptions, including the risk factors set
forth above. Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, expected, estimated or projected.
-11-
USE OF PROCEEDS
None of the proceeds from the sale of the Shares by the Selling
Stockholders will be received by the Company. The Company has agreed to bear
certain expenses in connection with the registration and sale of the Shares
being offered by the Selling Stockholders.
SELLING STOCKHOLDERS
The following table sets forth the name of each Selling Stockholder,
the number of shares of Common Stock beneficially owned by each Selling
Stockholder as of the date of this Prospectus, the number of shares of Common
Stock being offered by each Selling Stockholder hereby, and the percentage of
the Company's Common Stock to be beneficially owned by each Selling Stockholder
after the offering (assuming that all shares subject to this Prospectus are
sold). Common Stock ownership information is based solely upon reports furnished
to the Company by the respective Selling Stockholders pursuant to the rules of
the Commission.
Number of Shares of Number of Shares Percentage of
Common Stock of Common Stock Common Stock
Beneficially Owned Covered by this Beneficially Owned
Prior to Offering Prospectus After Offering
HealthCare Ventures I, L.P............... 255,132 255,132 *
HealthCare Ventures II, L.P.............. 199,391 199,391 *
HealthCare Ventures III, L.P............. 404,651 74,028 2.3%
HealthCare Ventures IV, L.P.............. 118,651 21,722 *
Marc E. Lippman.......................... 8,339 8,339 *
Michael L. Berman........................ 3,928 3,928 *
Ronald R. Baker.......................... 3,267 3,267 *
Nancy Howar.............................. 2,516 2,516 *
Prickett, Jones, Elliott, Kristol
& Schnee.............................. 1,950 1,950 *
- ---------------------------
* Less than one percent.
-12-
PLAN OF DISTRIBUTION
The Selling Stockholders may offer the shares of Common Stock subject
to this Prospectus from time to time for their own account in transactions on
The Nasdaq National Market, in negotiated transactions or otherwise, at market
prices prevailing at the time of sale, at prices related to such prevailing
market prices or at negotiated prices. The Selling Stockholders may effect such
transactions by selling the shares to or through broker-dealers and such
broker-dealers may receive compensation in the form of discounts, concessions or
commissions from the Selling Stockholders or the purchasers of the shares for
whom such broker-dealers may act as agent or to whom they sell as principal or
both (which compensation to a particular broker-dealer might be in excess of
customary commissions). The methods by which the shares may be sold include (i)
a block trade (which may involve crosses) in which the broker or dealer so
engaged will attempt to sell the securities as agent but may position and resell
a portion of the block as principal to facilitate the transaction; (ii)
purchases by a broker or dealer as principal and resale by such broker or dealer
for its account pursuant to this Prospectus; (iii) ordinary brokerage
transactions and transactions in which the broker solicits purchasers; and (iv)
privately negotiated transactions.
None of the proceeds from the sale of the shares of Common Stock
subject to this Prospectus by the Selling Stockholders will be received by the
Company. The Company has agreed to bear certain expenses in connection with the
registration and sale of the shares being offered by the Selling Stockholders.
The Selling Stockholders and any broker-dealers participating in the
distribution of the shares of Common Stock subject to this Prospectus may be
deemed to be "underwriters" within the meaning of the Securities Act.
The shares of Common Stock subject to this Prospectus have not been
registered for sale by the Selling Stockholders under the securities laws of any
state as of the date of this Prospectus. Brokers or dealers effecting
transactions in the shares should confirm registration thereof under the
securities laws of the states in which such transactions occur, or the existence
of any exemption from registration.
If underwriters are used in any offering of shares of Common Stock, the
underwriter or underwriters with respect to such offering will be named in a
Prospectus Supplement. Only underwriters named in a Prospectus Supplement will
be deemed to be underwriters in connection with the shares of Common Stock
offered thereby. Firms not so named will have no direct or indirect
participation in the underwriting of such Common Stock, although such a firm may
participate in the distribution of such Common Stock under circumstances
entitling it to a dealer's commission. Unless otherwise set forth in the
Prospectus Supplement relating to such offering, any underwriting agreement
pertaining to any offering of shares of Common Stock will (i) entitle the
underwriters to indemnification by the Company and the Selling Stockholders
against certain civil liabilities under the Securities Act; (ii) provide that
the obligations of the underwriters will be subject to certain conditions
precedent; and (iii) provide that the underwriters will be obligated to purchase
all shares of such Common Stock so offered if any shares are purchased. If
underwriters are used in any offering of Common Stock, the names of such
underwriters, the anticipated date of delivery and other material terms of the
transaction will be set forth in the Prospectus Supplement relating to such
offering.
Underwriters, brokers and dealers may engage in transactions with or
perform services for the Company in the ordinary course of business.
Offers to purchase Common Stock may be solicited, and sales thereof may
be made, by the Selling Stockholders directly to one or more purchasers in fixed
price offerings, in negotiated transactions, at market prices prevailing at the
time of sale or at prices related to such market prices. Certain of such
purchasers may be deemed to be underwriters with respect to any resale by them
of Common Stock so acquired. This Prospectus may be delivered by any such
purchaser in connection with any such resales. Such resales may be through
underwriters, brokers or dealers, or directly to one or more purchasers, all in
the manner described above.
-13-
DESCRIPTION OF THE COMPANY'S SECURITIES
GENERAL
The Company's Certificate of Incorporation provides for authorized
capital stock of 85,000,000 shares, consisting of 75,000,000 shares of common
stock, par value $0.001 per share, and 10,000,000 shares of preferred stock, par
value $0.001 per share. The following summary description of the capital stock
of the Company is qualified in its entirety by reference to the Certificate of
Incorporation, a copy of which is filed as an exhibit to the Registration
Statement of which this Prospectus is a part.
COMMON STOCK
Holders of Common Stock are entitled to one vote per share in the
election of directors and on all other matters on which stockholders are
entitled or permitted to vote. Holders of Common Stock are not entitled to
cumulative voting rights. Therefore, holders of a majority of the shares voting
for the election of directors can elect all the directors. Subject to the terms
of any outstanding series of Preferred Stock, the holders of Common Stock are
entitled to dividends in such amounts and at such times as may be declared by
the Company's Board of Directors out of funds legally available therefor. Upon
liquidation or dissolution, holders of Common Stock are entitled to share
ratably in all net assets available for distribution to stockholders after
payment of any liquidation preferences to holders of Preferred Stock. Holders of
Common Stock have no redemption, conversion or preemptive rights.
PREFERRED STOCK
The Board of Directors has the authority to cause the Company to issue
up to the authorized number of shares of Preferred Stock in one or more series,
to designate the number of shares constituting any series, and to fix the
rights, preferences, privileges and restrictions thereof, including dividend
rights, voting rights, redemption and conversion rights and liquidation
preferences of such series, without further action by the stockholders. The
issuance of Preferred Stock with voting and conversion rights may adversely
affect the voting power of the holders of the Common Stock. The Company has no
present plan to issue any shares of Preferred Stock.
WARRANTS
As of December 31, 1996, Aronex had outstanding warrants issued in
connection with financing transactions to purchase an aggregate of 60,624 shares
of Common Stock. In addition, as of December 31, 1996, Aronex had outstanding
Warrants issued in connection with the September 1995 merger with Oncologix to
purchase an aggregate of approximately 3.2 million shares of Common Stock. The
Oncologix Warrants are not transferable except under certain limited
circumstances. Each Warrant entitles the holder thereof to purchase a total of
one share of Common Stock and is subject to a Series A Exercise, a Series B
Exercise and a Series C Exercise. Subject to certain exceptions, holders of
Warrants were required to exercise the Series A Exercise, in whole but not in
part, prior to December 28, 1995 (January 2, 1996 after allowance of a five day
grace period).
The holders who exercised the Series A Exercise have the right, prior
to June 11, 1998, to exercise the Series B Exercise, in whole but not in part,
at an effective exercise price of $8.00 per share. In the event the Series B
Exercise has been exercised by a holder, then prior to December 11, 1999, the
Series C Exercise may be exercised, in whole but not in part, at an effective
exercise price of $12.00 per share of Common Stock. The holders of Warrants
outstanding as of December 31, 1996 have the right to purchase an aggregate of
approximately 1.4 million shares of Common Stock upon the Series B Exercise, and
an aggregate of approximately 1.8 million shares of Common Stock upon the Series
C Exercise (assuming the full exercise of the Series B Exercise by the holders
of outstanding Oncologix Warrants).
Aronex has the right, at its option, to convert a Series B or Series C
Exercise into a "cashless" exercise based on the value of a Series B or Series C
Exercise (equal to the fair market value per share of the Common Stock less the
exercise price per share) divided by the market price of the Common Stock at the
time of exercise.
-14-
CONTINGENT STOCK RIGHTS
In connection with the Triplex merger, the Company issued contingent
rights (the "Triplex Contingent Stock Rights") to the former holders of Triplex
stock and options entitling them to receive additional shares of Common Stock
upon the occurrence of certain events. The Triplex Contingent Stock Rights
entitle the former Triplex stock and option holders to receive shares of Common
Stock with an aggregate fair market value at the time of issuance of $5.0
million (subject to certain adjustments) if the Company either (i) enters into
an agreement on or before September 11, 1997 with respect to the licensing of
ZintevirTM whereby the Company receives at least $5.0 million in cash or an
unconditional binding commitment for at least $5.0 million or (ii) obtains data
from clinical trials of ZintevirTM on or before September 11, 2000 that the
Company's Board of Directors determines to be sufficient to file an NDA. In
addition, the Triplex Contingent Stock Rights entitle the former Triplex stock
and option holders to receive shares of Common Stock with an aggregate fair
market value at the time of issuance of $3.0 million if the Company does not
receive a minimum of $5.0 million in equity milestone payments from Genzyme on
or before September 11, 1997 with respect to the development of TretinoinLF. In
no event, however, shall more than 3,500,097 shares of Common Stock (subject to
adjustments in the event of stock splits, stock dividends or reclassification of
the Common Stock) be issued pursuant to the Triplex Contingent Stock Rights.
In connection with the Oncologix merger, the Company issued contingent
rights (the "Oncologix Contingent Stock Rights") to certain Oncologix investors
entitling them to receive additional shares of Common Stock upon the occurrence
of certain events. The Oncologix Contingent Stock Rights entitle such former
Oncologix investors to receive shares of Common Stock with a fair market value
at the time of issuance of approximately $2.1 million if the Company receives at
least $5.0 million in cash or an unconditional binding commitment for at least
$5.0 million on or before September 11, 1997 relating to certain products,
including AR102 and AR209. In no event, however, shall more than 2,135,000
shares of Common Stock (subject to certain adjustments) be issued pursuant to
the Oncologix Contingent Stock Rights.
CERTAIN PROVISIONS OF THE COMPANY'S CHARTER AND BYLAWS AND DELAWARE LAW
Certain provisions of the Certificate of Incorporation and Bylaws are
intended to enhance the likelihood of continuity and stability in the Board of
Directors of the Company and in its policies, but might have the effect of
delaying or preventing a change in control of the Company and may make more
difficult the removal of incumbent management even if such transactions could be
beneficial to the interests of stockholders. Set forth below is a summary
description of such provisions:
Authority to Issue Preferred Stock. The Company's Certificate of
Incorporation authorizes the Board of Directors, without stockholder approval,
to establish and to issue shares of one or more series of preferred stock, each
such series having such voting rights, dividend rates, liquidation, redemption,
conversion and other rights as may be fixed by the Board.
Stockholder Actions and Meetings. The Company's Bylaws direct that
special meetings of the stockholders may only be called by a majority of the
members of the Board of Directors, the Chairman of the Board of Directors, the
President of the Company or the holders of not less than 30 percent of the total
voting power of all shares of the Company's capital stock entitled to vote in
the election of directors. The Bylaws further provide that stockholders'
nominations to the Board of Directors and other stockholder business proposed to
be transacted at stockholder meetings must be timely received by the Company in
a proper written form which meets the prescribed content requirements. The
Certificate of Incorporation and Bylaws of the Company prohibit stockholders
from taking any action by written consent.
Classification of Directors. The Company's Certificate of
Incorporation and Bylaws provide that the directors of the Company shall be
divided into three classes as equal in number as possible serving three-year
terms.
Limitation of Director Liability. Section 102(b)(7) of the Delaware
General Corporation Law ("Section 102(b)") authorizes corporations to limit or
eliminate the personal liability of directors to corporations and their
stockholders for monetary damages for breach of directors' fiduciary duty of
care. Although Section 102(b) does not
-15-
change directors' duty of care, it enables corporations to limit available
relief to equitable remedies such as injunction or rescission. The Company's
Certificate of Incorporation limits the liability of directors to the Company or
its stockholders (in their capacity as directors but not in their capacity as
officers) to the fullest extent permitted by Section 102(b). Specifically,
directors of the Company will not be personally liable for monetary damages for
breach of a director's fiduciary duty as a director, except for liability: (i)
for any breach of the director's duty of loyalty to the Company or its
stockholders, (ii) for acts or omissions not in good faith or which involve
intentional misconduct or a knowing violation of law, (iii) for unlawful
payments of dividends or unlawful stock repurchases or redemptions as provided
in Section 174 of the Delaware General Corporation Law or (iv) for any
transaction from which the director derived an improper personal benefit.
Indemnification. To the maximum extent permitted by law, the Company's
Certificate of Incorporation and Bylaws provide for mandatory indemnification of
directors, and permit indemnification of officers, employees and agents of the
Company against all expense, liability and loss to which they may become subject
or which they may incur as a result of being or having been a director, officer,
employee or agent of the Company. In addition, the Company must advance or
reimburse directors, and may advance or reimburse officers, employees and agents
for expenses incurred by them in connection with indemnifiable claims.
Section 203 of the Delaware General Corporation Law ("Section 203")
generally provides that a stockholder acquiring more than 15 percent of the
outstanding voting stock of a corporation subject to the statute (an "Interested
Stockholder") but less than 85 percent of such stock may not engage in certain
"Business Combinations" with the corporation for a period of three years after
the date on which the stockholder became an Interested Stockholder unless (i)
prior to such date, the corporation's board of directors approved either the
Business Combination or the transaction in which the stockholder became an
Interested Stockholder, or (ii) the Business Combination is approved by the
corporation's board of directors and authorized at a stockholders' meeting by a
vote of at least two-thirds of the corporation's outstanding voting stock not
owned by the Interested Stockholder. Under Section 203, these restrictions will
not apply to certain Business Combinations proposed by an Interested Stockholder
following the earlier of the announcement or notification of one of certain
extraordinary transactions involving the corporation and a person who was not an
Interested Stockholder during the previous three years or who became an
Interested Stockholder with the approval of the corporation's board of
directors, if such extraordinary transaction is approved or not opposed by a
majority of the directors who were directors prior to any person becoming an
Interested Stockholder during the previous three years or were recommended for
election or elected to succeed such directors by a majority of such directors.
Section 203 defines the term "Business Combination" to encompass a wide
variety of transactions with or caused by an Interested Stockholder, including
transactions in which the Interested Stockholder receives or could receive a
benefit on other than a pro rata basis with other stockholders, such as mergers,
certain asset sales, certain issuances of additional shares to the Interested
Stockholder, transactions with the corporation which increase the proportionate
interest in the corporation directly or indirectly owned by the Interested
Stockholder, or transactions in which the Interested Stockholder receives
certain other benefits.
The provisions of Section 203, together with the ability of the
Company's Board of Directors to issue Preferred Stock without further
stockholder action, could delay or frustrate the removal of incumbent directors
or a change in control of the Company. The provisions also could discourage,
impede or prevent a merger, tender offer or proxy contest, even if such event
would be favorable to the interests of stockholders. The Company's stockholders,
by adopting an amendment to the Company's Certificate of Incorporation or
Bylaws, may elect not to be governed by Section 203 effective 12 months after
such adoption. Neither the Company's Certificate of Incorporation nor Bylaws
currently exclude the Company from the restrictions imposed by Section 203.
-16-
TRANSFER AGENT
The transfer agent and registrar for the Common Stock is American Stock
Transfer & Trust Company.
STOCKHOLDERS AGREEMENT
The Company and certain of its stockholders who hold an aggregate of
approximately [4,834,808] shares of Common Stock, are parties to a Stockholders
Agreement which provides that the Board of Directors of Aronex shall consist of
nine members, divided into three classes designated as Class I, Class II and
Class III. The Stockholders Agreement provides that of the nine directors, three
shall be designated by certain former Triplex stockholders, three shall be
designated by certain former Argus stockholders, one shall be designated by
Genzyme, one shall be designated by certain former Oncologix stockholders, and
one shall be the president of the Company elected by the Board of Directors.
Such agreement further provides that the three directors designated by the
former Triplex stockholders shall be equally apportioned among the three
director classes so that one of such directors shall be included in each class.
Any vacancy occurring on the board by reason of death, disability or retirement,
resignation, removal or otherwise shall be filled by a new director designated
by the stockholders who are entitled to designate the director who is no longer
on the board. Of the Company's current directors, Ronald J. Brenner and Gregory
F. Zaic are designees of the former Triplex stockholders, Gabriel
Lopez-Berestein, George B. Mackaness and Martin P. Sutter are designees of the
former Argus stockholders and Geoffrey F. Cox is the designee of Genzyme; James
M. Chubb serves as a member of the board as the Company's President. The Board
of Directors currently has two vacancies, one of which the former Oncologix
stockholders are entitled to designate and the other of which the former Triplex
stockholders are entitled to designate. Each stockholder who is a party of the
Stockholders Agreement has agreed to vote all of his shares of Common Stock in
favor of the election as a director of the individuals designated for election
in accordance with the Stockholders Agreement. The Stockholders Agreement shall
continue in effect until the later of (i) the completion of the second annual
meeting of stockholders of the Company after September 11, 1995 and (ii)
September 11, 1997. See "Risk Factors -- Control by Existing Stockholders."
REGISTRATION RIGHTS
The Company entered into registration rights agreements dated September
1, 1986 with Dr. Jim Klostergaard and Dr. Gabriel Lopez-Berestein. Pursuant to
such Agreements, Drs. Klostergaard and Lopez-Berestein have unlimited
"piggyback" registration rights with respect to the shares of Common Stock owned
by them. These registration rights are subject to certain conditions and
limitations, including the right of the underwriters to restrict the number of
shares offered in a registration.
Pursuant to a registration rights agreement dated August 2, 1989,
holders of approximately 2,447,500 shares of Common Stock and of warrants to
purchase 60,624 shares of Common Stock have the right to demand up to three
registrations of the Registrable Securities (as defined) under the Securities
Act and unlimited piggyback registration rights. These demand registration
rights are subject to certain conditions and limitations, including the right of
the underwriters to limit the number of shares offered in such registration and
to require a lock-up of shares not included in such registration and the right
of the Company to refuse a registration under certain conditions, such as the
six-month period immediately following effectiveness of a registration statement
and the ninety-day period preceding an expected filing of a registration
statement. If the Company proposes an offering of Registrable Securities, either
for its own account or for other stockholders exercising such registration
rights, the other holders of these rights are entitled to notice of the
contemplated registration and an opportunity to include their securities in such
registration. The Company must use its best efforts to effect such registration,
with certain limitations. Furthermore, the Company is required to pay the
associated registration expenses, excluding the underwriting discounts and sales
commissions, for the holders exercising such registration rights.
In addition, Genzyme has one demand registration right, which requires
Aronex to register all shares of Common Stock Genzyme currently holds or may
acquire in the future. Genzyme has agreed not to sell its shares of Common Stock
prior to March 11, 1997, subject to certain exceptions.
-17-
In connection with the Triplex merger, the Company granted the former
stockholders of Triplex unlimited piggyback registration rights which provide
that, if Aronex proposes an offering of Common Stock, either for its own account
or for other stockholders exercising registration rights, the holders of the
rights are entitled to notice of the contemplated registration and an
opportunity to include their Aronex Common Stock in such registration, subject
to certain limitations. These registration rights have been or will be waived in
connection with this offering.
LEGAL MATTERS
Certain legal matters with respect to the validity of the Common Stock
offered hereby are being passed on for the Company by Andrews & Kurth, L.L.P.,
The Woodlands, Texas.
EXPERTS
The financial statements incorporated by reference in this Registration
Statement from the Company's Annual Report on Form 10-K for the year ended
December 31, 1995, as amended, have been audited by Arthur Andersen LLP,
independent public accountants, as indicated in their report with respect
thereto, and are incorporated by reference herein in reliance upon the authority
of said firm as experts in giving said report.
-18-
No dealer, salesperson or other person has been authorized to give any
information or to make any representations other than those contained in or
incorporated by reference 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. Neither the delivery of this
Prospectus nor any sale made hereunder shall, under any circumstances, create
any implication that there has been no change in the affairs of the Company
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 is not qualified to
do so or to any person to whom it is unlawful to make such solicitation.
---------------------------
[LOGO AND NAME OF
ARONEX PHARMACEUTICALS, INC.]
570,273 Shares of
Common Stock
----------
PROSPECTUS
----------
TABLE OF CONTENTS
Page
Available Information........................ 2
Documents Incorporated by Reference.......... 2
The Company.................................. 4
Risk Factors................................. 5
Use of Proceeds.............................. 12
Selling Stockholders......................... 12
Plan of Distribution......................... 13
Description of the Company's
Securities................................... 14
Legal Matters................................ 18
Experts...................................... 18
MARCH 7, 1997
------------------------------------------------------
-19-
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
Set forth below are the expenses expected to be incurred in connection
with the issuance and distribution of the securities registered hereby. With the
exception of the Securities and Exchange Commission registration fee, the
amounts set forth below are estimates and consist exclusively of expenses
incurred in connection with this amendment on Form S-3:
Securities and Exchange Commission registration fee............... $ 1,383
Printing and engraving expenses................................... 1,000
Legal fees and expenses........................................... 6,000
Accounting fees and expenses...................................... 5,000
Blue Sky fees and expenses........................................ --
Miscellaneous expenses............................................ 1,617
---------
Total.................................................... $ 15,000
- ---------------------------
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 145 of the Delaware General Corporation Law ("DGCL"), inter
alia, empowers a Delaware corporation to indemnify any person who was or is a
party or is threatened to be made a party to any threatened, pending or
completed action, suit or proceeding (other than an action by or in the right of
the corporation) by reason of the fact that such person is or was a director,
officer, employee or agent of the corporation, or is or was serving at the
request of the corporation as a director, officer, employee or agent of another
corporation or other enterprise, against expenses (including attorneys' fees),
judgments, fines and amounts paid in settlement actually and reasonably incurred
by him in connection with such action, suit or proceeding if he acted in good
faith and in a manner he reasonably believed to be in or not opposed to the best
interests of the corporation, and, with respect to any criminal action or
proceeding, had no reasonable cause to believe his conduct was unlawful. Similar
indemnity is authorized for such persons against expenses (including attorneys'
fees) actually and reasonably incurred in connection with the defense or
settlement of any such threatened, pending or completed action or suit if such
person acted in good faith and in a manner he reasonably believed to be in or
not opposed to the best interests of the corporation, and provided further that
(unless a court of competent jurisdiction otherwise provides) such person shall
not have been adjudged liable to the corporation. Any such indemnification may
be made only as authorized in each specific case upon a determination by the
stockholders or disinterested directors or by independent legal counsel in a
written opinion that indemnification is proper because the indemnitee has met
the applicable standard of conduct.
Section 145 further authorizes a corporation to purchase and maintain
insurance on behalf of any person who is or was a director, officer, employee or
agent of the corporation, or is or was serving at the request of the corporation
as a director, officer, employee or agent of another corporation or enterprise,
against any liability asserted against him and incurred by him in any such
capacity, or arising out of his status as such, whether or not the corporation
would otherwise have the power to indemnify him under Section 145. The Company
maintains policies insuring its and its subsidiaries' officers and directors
against certain liabilities for actions taken in such capacities, including
liabilities under the Securities Act of 1933, as amended (the "Securities Act").
Article VIII of the Amended and Restated Certificate of Incorporation
of the Company and Article VII of the Bylaws of the Company provide for
indemnification of the directors of the Company to the full extent permitted by
law, as now in effect or later amended. Article VII of the Bylaws also permits
the indemnification to the same extent of officers, employees or agents of the
Company if, and to the extent, authorized by the Board of Directors. In
addition, the Bylaws provide for indemnification against expenses incurred by a
director to be paid by the Company at reasonable intervals in
II-1
advance of the final disposition of such action, suit or proceeding upon receipt
of an undertaking by or on behalf of the director or officer to repay such
amount if it shall be ultimately determined that he is not entitled to be
indemnified by the Company. The Bylaws further provide for a contractual cause
of action on the part of directors of the Company for indemnification claims
that have not been paid by the Company.
The Company also has provided liability insurance for each director and
officer for certain losses arising from claims or charges made against them
while acting in their capacities as directors or officers of the Company.
Article VII of the Company's Amended and Restated Certificate of
Incorporation, as amended, limits under certain circumstances the liability of
the Company's directors for a breach of their fiduciary duty as directors. These
provisions do not eliminate the liability of a director (i) for a breach of the
director's duty of loyalty to the Company or its stockholders, (ii) for acts or
omissions not in good faith or that involve intentional misconduct or a knowing
violation of law, (iii) under Section 174 of the DGCL (relating to the
declaration of dividends and purchase or redemption of shares in violation of
the DGCL) or (iv) for any transaction from which the director derived an
improper personal benefit.
Item 16. Exhibits
4.1 Form of Common Stock Certificate (incorporated by reference to
Exhibit 4.1 to the Company's Quarterly Report on Form 10-Q for the
quarterly period ended June 30, 1996).
*5.1 Opinion of Andrews & Kurth L.L.P.
*23.1 Consent of Arthur Andersen LLP
*23.2 Consent of Andrews & Kurth L.L.P. (included in Exhibit 5.1)
*24.1 Powers of Attorney (included as part of the signature page of this
Registration Statement).
- ----------------------
* Filed herewith.
II-2
Item 17. Undertakings
(1) The undersigned registrant hereby undertakes:
(a) To file, during any period in which offers or sales are
being made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section
10(a)(3) of the Securities Act of 1933, as amended
(the "Securities Act");
(ii) To reflect in the prospectus any facts or events
arising after the effective date of the
Registration Statement (or the most recent
post-effective amendment thereof) which,
individually or in the aggregate, represent a
fundamental change in the information set forth in
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
end of the estimated maximum offering range may be
reflected in the form of prospectus filed with the
Commission pursuant to Rule 424(b) (ss. 230.424(b)
of this chapter) if, in the aggregate, the changes
in volume and price represent no more than a 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 this Registration Statement or any
material change to such information in the
Registration Statement.
(b) That, for the purpose of determining any liability under
the Securities Act of 1933, each such post-effective amendment shall be
deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
(c) To remove from registration by means of a post-effective
amendment any of the securities being registered which remain unsold at
the termination of the offering.
(2) The undersigned registrant hereby undertakes that, for
purposes of determining any liability under the Securities Act of 1933, each
filing of the registrant's annual report pursuant to section 13(a) or section
15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing
of an employee benefit plan's annual report pursuant to section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
(3) 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 by paid by a director officer or controlling
person 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 its
against public policy as expressed in the Act and will be governed by the final
adjudication of such issue.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1933,
the Registrant certifies that is 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 The Woodlands, State of Texas on the 7th day of
March, 1997.
ARONEX PHARMACEUTICALS, INC.
By: /s/ James M. Chubb
-----------------------------------
James M. Chubb
President
KNOW ALL MEN BY THESE PRESENTS, that each of the undersigned officers
and directors of Aronex Pharmaceuticals, Inc. (the "Company") hereby constitutes
and appoints James M. Chubb and Terance A. Murnane, or either of them (with full
power to each of them to act alone), his true and lawful attorney-in-fact and
agent, with full power of substitution and resubstitution, for him and on his
behalf and in his name, place and stead, in any and all capacities, to sign,
execute and file this Registration Statement under the Securities Act of 1933,
as amended, and any or all amendments (including, without limitation,
post-effective amendments), with all exhibits and any and all documents required
to be filed with respect thereto, with the Securities and Exchange Commission or
any regulatory authority, granting unto such attorneys-in-fact and agents, and
each of them acting alone, full power and authority to do and perform each and
every act and thing requisite and necessary to be done in and about the premises
in order to effectuate the same, as fully to all intents and purposes as he
himself might or could do if personally present, hereby ratifying and confirming
all that such attorneys-in-fact and agents, or any of them, or their substitute
or substitutes, may lawfully do or cause to be done.
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.
Signature Title Date
/s/ James M. Chubb President March 7, 1997
- ----------------------------------------
James M. Chubb (Principal Executive Officer)
/s/ Terance A. Murnane Controller March 7, 1997
- ----------------------------------------
Terance A. Murnane (Principal Financial and Accounting Officer)
/s/ Martin P. Sutter Chairman of the Board of Directors March 7, 1997
- ----------------------------------------
Martin P. Sutter
/s/ Gabriel Lopez-Berestein Director March 7, 1997
Gabriel Lopez-Berestein
/s/ Ronald J. Brenner Director March 7, 1997
- ----------------------------------------
Ronald J. Brenner
- ---------------------------------------- Director March , 1997
Geoffrey F. Cox
/s/ George B. Mackaness Director March 7, 1997
- ----------------------------------------
George B. Mackaness
- ---------------------------------------- Director March , 1997
Gregory F. Zaic
II-4