- Tolerability and proof-of-mechanism for lead
candidate AVB-S6-500, a novel GAS6-AXL pathway inhibitor,
established in ongoing Phase 1 clinical study
Versartis, Inc. (NASDAQ:VSAR), and Aravive Biologics, Inc., today
jointly announced that they have entered into a definitive
agreement under which Aravive will merge with a wholly owned
subsidiary of Versartis in an all-stock transaction. The
transaction will result in a clinical stage, Nadsaq-listed company,
based in Houston, Texas, focused on the development of innovative
oncology therapeutics.
Aravive Biologics is a privately held clinical
stage biopharmaceutical company developing novel, highly selective
therapies designed to treat serious cancers and certain fibrotic
diseases.
Aravive’s lead program is focused on inhibition of the GAS6-AXL
signaling axis, which is a known target associated with the growth
and proliferation of multiple tumor types. In preclinical studies,
GAS6-AXL inhibition has shown activity, whether achieved by a
single agent or in combination with a variety of anticancer
therapies including radiation therapy, immuno-oncology agents, and
drugs that affect DNA replication and repair. Clinically, elevated
GAS6 levels have been associated with poor prognosis in cancer.
Aravive has established clinical proof-of mechanism for its
first-in-class drug candidate, demonstrating full GAS6
neutralization with AVB-S6-500, and plans to initiate an expanded
clinical development program combining it with standard of care
therapies in patients with a number of tumor types, initially in
ovarian cancers in the second half of 2018.
“Following an extensive and thorough review of strategic
options, we are very pleased to announce our agreement to merge
with Aravive. The transaction will provide Versartis stockholders
with a significant ownership stake in a promising biopharmaceutical
company with a novel approach that has the potential to enhance
therapeutic efficacy for patients facing a variety of resistant or
metastatic cancers,” said Jay Shepard, Chief Executive Officer of
Versartis. “The combined company offers a compelling pipeline, as
well as talent and financial resources to advance the clinical
development program to multiple important inflection points over
the next 24 months.”
Jay Shepard, President and Chief Executive Officer of Versartis,
will be Chief Executive Officer of the combined company, based in
Houston, Texas. Srinivas Akkaraju, M.D., Ph.D. will serve as
Chairman of the Board and Ray Tabibiazar, M.D., currently Aravive’s
Executive Chairman, will continue to serve on the Board of
Directors of the combined company. The remaining senior
management team will be comprised of current Aravive and Versartis
personnel. The board of the combined company is anticipated to be
comprised of seven representatives, with three designated by
Versartis, three designated by Aravive, and one independent
director mutually agreed by the companies.
“This proposed merger will provide Aravive with the financial
resources and experienced leadership to significantly advance the
company in its aim to build a successful, innovative oncology
business,” said Ray Tabibiazar, M.D., Executive Chairman of Aravive
Biologics. “Jay Shepard has the right qualities to helm the
combined company. He possesses significant operating experience
across the biotechnology and pharmaceutical industry including
commercial development in oncology, as well as experience leading
publicly traded companies and a successful M&A track record.
Moreover, Versartis’ development and commercial planning expertise,
as well as its operational proficiency, will complement the strong
scientific and clinical capabilities of the Aravive team.”
Aravive’s Lead Drug Candidate - AVB-S6-500
Aravive’s lead program is focused on GAS6-AXL signaling, a key
molecular pathway whose significance as a target in oncology
is supported by extensive research represented by more than 500
publications over the past 10 years. AVB-S6-500, Aravive’s lead
development candidate, is a novel decoy molecule that binds to GAS6
with very high affinity and selectivity, preventing it from binding
AXL and thus inhibiting AXL signaling. Aravive’s technology
originated in the Stanford University laboratories of Amato
Giaccia, Ph.D., scientific founder of Aravive, and colleagues at
Stanford University.
AVB-S6-500 is currently in a Phase 1 clinical study in
healthy volunteers, and Aravive is poised to expand its
development program for the drug candidate during the second
half of 2018, beginning with the Phase 1b portion of a Phase
1b/2 trial in ovarian cancer. Initial data from that
study and the initiation of additional studies in other
targeted tumor types overexpressing AXL are expected in
2019.
Aravive History
Since its founding in 2016, Aravive has raised over $11.4
million in venture capital and received a $20 million grant from
the Cancer Prevention & Research Institute of Texas (CPRIT),
the largest single corporate grant awarded by CPRIT to date. Under
the leadership of Dr. Tabibiazar, the company was named by
FierceBiotech as one of 2017’s Fierce 15 biotechnology companies,
designating it as one of the most promising private biotechnology
companies in the industry.
Proposed Transaction Details
Following the proposed merger, Versartis and Aravive equity
holders are each expected to own approximately 50 percent of the
combined company.
The transaction has been unanimously approved by the boards of
directors of both companies. The transaction is expected to close
during the second half of 2018, subject to approval by the
stockholders of both companies and the satisfaction or waiver of
other customary closing conditions.
Cowen acted as exclusive financial advisor to Versartis on the
proposed transaction and Cooley LLP served as legal counsel to
Versartis. Wedbush PacGrow acted as exclusive financial advisor to
Aravive on the proposed transaction and Gracin & Marlow, LLP
and Lowenstein Sandler LLP served as legal counsel to Aravive.
Organization
Upon the closing of the transaction, the merged company will
operate under the Aravive Inc. name, and the company’s common stock
is expected to continue to trade on NASDAQ under a new ticker
symbol to be announced at a later date.
A presentation summarizing the proposed merger and providing
additional background information will be filed on form 8-K and be
made available on the www.versartis.com website. Information on the
Versartis website is not part of this press release.
About Versartis, Inc.
Versartis, Inc. (NASDAQ:VSAR) is a biopharmaceutical company led
by a management team with rich experience and expertise
discovering, developing and commercializing innovative therapeutics
for the life sciences industry, including in the field of
oncology.
About Aravive Biologics, Inc.
Aravive Biologics is a privately held clinical stage
biopharmaceutical company developing novel, highly selective
therapies designed to treat serious cancers and certain fibrotic
diseases. The company’s lead program is focused on the GAS6-AXL
pathway. Aravive Biologics has generated strong preclinical data
for its lead drug candidate AVB-S6-500 in a variety of cancer
models and is currently conducting a Phase 1 clinical study. The
company is based in Houston, Texas, and receives support from the
Cancer Prevention & Research Institute of Texas (CPRIT). For
more information, please visit the company website at
www.aravive.com. Information on the Aravive website is not
part of this press release.
Forward-Looking Statements
This communication contains forward-looking statements
(including within the meaning of Section 21E of the United States
Securities Exchange Act of 1934, as amended, and Section 27A of the
United States Securities Act of 1933, as amended) concerning
Versartis, Aravive, the merger and other matters. These statements
may discuss goals, intentions and expectations as to future plans,
trends, events, results of operations or financial condition, or
otherwise, based on current beliefs of the management of Versartis,
as well as assumptions made by, and information currently available
to, management. Forward-looking statements generally include
statements that are predictive in nature and depend upon or refer
to future events or conditions, and include words such as “may,”
“will,” “should,” “would,” “expect,” “anticipate,” “plan,”
“likely,” “believe,” “estimate,” “project,” “intend,” and other
similar expressions among others. Statements that are not
historical facts are forward-looking statements. Forward-looking
statements included in this communication include statements
regarding the anticipated completion of the proposed merger and
Aravive’s planned clinical activities, including the initiation and
availability of data from clinical studies. Forward-looking
statements are based on current beliefs and assumptions that are
subject to risks and uncertainties and are not guarantees of future
performance. Actual results could differ materially from those
contained in any forward-looking statement as a result of various
factors, including, without limitation: the risk that the
conditions to the closing of the merger are not satisfied,
including the failure to timely or at all obtain stockholder
approval for the merger; uncertainties as to the timing of the
consummation of the merger and the ability of each of Versartis and
Aravive to consummate the merger; risks related to Versartis’s
ability to correctly estimate its operating expenses and its
expenses associated with the merger; risks related to the market
price of Versartis’s common stock relative to the exchange ratio;
the ability of Versartis or Aravive to protect their respective
intellectual property rights; competitive responses to the merger;
unexpected costs, charges or expenses resulting from the merger;
potential adverse reactions or changes to business relationships
resulting from the announcement or completion of the merger;
provisions in certificate of incorporation, bylaws and laws of
Delaware containing provisions that could delay or discourage a
change in control of the Company; and legislative, regulatory,
political and economic developments. The foregoing review of
important factors that could cause actual events to differ from
expectations should not be construed as exhaustive and should be
read in conjunction with statements that are included herein and
elsewhere, including the risk factors included in Versartis’s most
recent Annual Report on Form 10-K, Versartis’ recent Quarterly
Report on Form 10-Q and Current Reports on Form 8-K filed, each as
filed with or furnished to the SEC. Versartis can give no assurance
that the conditions to the merger will be satisfied. Except as
required by applicable law, Versartis undertakes no obligation to
revise or update any forward-looking statement, or to make any
other forward-looking statements, whether as a result of new
information, future events or otherwise.
No Offer or Solicitation
This communication is not intended to and does not constitute an
offer to sell or the solicitation of an offer to subscribe for or
buy or an invitation to purchase or subscribe for any securities or
the solicitation of any vote in any jurisdiction pursuant to the
merger or otherwise, nor shall there be any sale, issuance or
transfer of securities in any jurisdiction in contravention of
applicable law. No offer of securities shall be made except by
means of a prospectus meeting the requirements of Section 10 of the
United States Securities Act of 1933, as amended. Subject to
certain exceptions to be approved by the relevant regulators or
certain facts to be ascertained, the public offer will not be made
directly or indirectly, in or into any jurisdiction where to do so
would constitute a violation of the laws of such jurisdiction, or
by use of the mails or by any means or instrumentality (including
without limitation, facsimile transmission, telephone and the
internet) of interstate or foreign commerce, or any facility of a
national securities exchange, of any such jurisdiction.
Important Additional Information Will be Filed with the
SEC
This communication relates to the proposed transaction pursuant
to the terms of the Agreement and Plan of Merger, dated as of June
3, 2018, by and among Versartis, Inc., Velo Merger Sub, Inc. and
Aravive Biologics, Inc. In connection with the proposed
transaction between Versartis and Aravive, Versartis intends to
file relevant materials with the SEC, including a registration
statement that will contain a proxy statement and prospectus.
VERSARTIS URGES INVESTORS AND STOCKHOLDERS TO READ THESE
MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME
AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT
VERSARTIS, THE MERGER AND RELATED MATTERS. Investors and
shareholders will be able to obtain free copies of the proxy
statement, prospectus and other documents filed by Versartis with
the SEC (when they become available) through the website maintained
by the SEC at www.sec.gov. In addition, investors and shareholders
will be able to obtain free copies of the proxy statement,
prospectus and other documents filed by Versartis with the SEC by
contacting Versartis, Inc., 1020 Marsh Road, Menlo Park, California
94025, Attention: Corporate Secretary. Investors and stockholders
are urged to read the proxy statement, prospectus and the other
relevant materials when they become available before making any
voting or investment decision with respect to the merger.
Participants in the Solicitation
Versartis and Aravive, and each of their respective directors
and executive officers and certain of their other members of
management and employees, may be deemed to be participants in the
solicitation of proxies in connection with the merger. Information
about Versartis’s directors and executive officers is included in
Versartis’s Annual Report on Form 10-K for the year ended December
31, 2017, filed with the SEC on March 6, 2018, and the Form 10-K/A
filed with the SEC on April 11, 2018. Additional information
regarding these persons and their interests in the merger will be
included in the proxy statement relating to the merger when it is
filed with the SEC. These documents can be obtained free of charge
from the sources indicated above.
Contacts:
Versartis, Inc.:Paul WestbergChief Business Officer(650)
963-8585pwestberg@versartis.com
Christine Labaree (650) 600-1697 clabaree@evergreencomms.com
Aravive Biologics, Inc.:Vinay ShahChief Financial
OfficerVinay@aravive.com
Joan E. KureczkaJoan@bioscribe.com(415) 690-0210
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