Market Overview

U.S. FDA Grants Fast Track Designation to Aravive Biologics' AVB-S6-500


Aravive Biologics, Inc. announced today that the U.S. Food and Drug
Administration has granted Fast Track Designation to AVB-S6-500 as a
potential treatment for platinum-resistant recurrent ovarian cancer.

"Gaining Fast Track Designation is an important recognition of the
potential that AVB-S6-500 has to offer to meet a critical unmet medical
need for patients with recurrent ovarian cancer," said Ray Tabibiazar,
M.D., Executive Chairman of Aravive Biologics. "We look forward to
initiating the Phase 1b portion of our planned Phase 1b/2 study
combining AVB-S6-500 with standard-of care therapies in patients with
platinum-resistant ovarian cancer before the end of the year."

The FDA's Fast Track Designation is intended to facilitate development
and expedite review of drugs to treat serious conditions and fill an
unmet medical need. The purpose is to get important new drugs to the
patient earlier.

"We are very pleased that the FDA has granted Fast Track status to
AVB-S6-500," said Gail McIntyre Ph.D., DABT, Senior Vice President of
R&D at Aravive. "This important designation is based on the promising
safety and activity observed to-date with AVB-S6-500, and we look
forward to working closely with the FDA as we advance its development in
ovarian cancer."

About AVB-S6-500

AVB-S6-500 is a novel high-affinity, soluble Fc-fusion protein designed
to block the activation of the GAS6-AXL signaling pathway by
intercepting the binding of GAS6 to its receptor AXL. Research has shown
GAS6-AXL signaling to be a key molecular pathway that promotes tumor
growth and metastases, as well as immune evasion and resistance to other
anticancer agents. AXL and GAS6 expression correlate with poor prognosis
in cancer. Results of a Phase 1 study of AVB-S6-500 in healthy
volunteers showed a favorable safety profile, with no reported serious
or dose-limiting adverse events. Moreover, results of that trial showed
a dose-related reduction of circulating free GAS6, a measurement that
Aravive anticipates will be highly useful as a biomarker to better
monitor the therapeutic responses and potentially to better select
responder patient populations. A reduction in this biomarker has
correlated to anti-tumor activity in preclinical animal studies. In
preclinical studies, GAS6-AXL inhibition has shown activity, whether
achieved by a single agent (including AVB-S6-500) or through
combinations of a variety of anticancer therapies including radiation
therapy, immuno-oncology agents, and drugs that affect DNA replication
and repair. GAS6/AXL inhibition has also shown potential as a strategy
for the treatment of certain fibrotic diseases.

About Aravive Biologics

Aravive Biologics is a clinical stage pharmaceutical company focused on
developing novel, highly selective therapies designed to treat serious
cancers and certain fibrotic diseases. The company's primary therapeutic
focus is the GAS6-AXL pathway, where AXL receptor signaling plays a
critical role in multiple types of malignancies by promoting metastasis
and cancer cell survival. Aravive Biologics has generated strong
preclinical data for its lead drug candidate AVB-S6-500 in a variety of
cancer models and recently completed a Phase 1 clinical study that
established proof of mechanism at all doses tested in human subjects and
suppressed serum GAS6 for at least one week. The company is based in
Houston, Texas, and receives support from the Cancer Prevention &
Research Institute of Texas (CPRIT). On June 3, 2018, Aravive entered
into an Agreement and Plan of Merger and Reorganization with Versartis,
Inc., and its wholly owned subsidiary Velo Merger Sub, Inc. For more
information, please visit our website at
Information contained on or accessed through our web site is not part of
this press release.

Forward Looking Statement

This press release contains forward-looking statements. Forward-looking
statements contained in this press release include, without limitation,
statements regarding the timing of the initiation of the Phase1b portion
of the Phase1b/ Phase 2 clinical trial, inhibition of the GAS6-AXL
pathway as a strategy for the treatment of certain fibrotic diseases,
and dose-related reduction of circulating free GAS6 being a measurement
that will be highly useful as a biomarker of drug activity in future
clinical studies and the benefits to be derived from Fast Track
Designation. These forward-looking statements are not guarantees of
future performance and involve a number of unknown risks, assumptions,
uncertainties and factors that are beyond our control, including, but
not limited to, the potential of AVB-S6-500's mechanism of action in
additional clinical trials to represent a novel approach to inhibiting
tumor growth and metastasis, as well as address tumor immune evasion and
resistance to other anticancer agents, use of the GAS6 assay as a
valuable biomarker of drug activity for future clinical studies, the
potential of the inhibition of the GAS6-AXL signaling pathway to
overcome tumor resistance and increase the efficacy of a variety of
anticancer agents, the potential of GAS6-AXL inhibition as a strategy
for the treatment of certain fibrotic diseases, the potential of
AVB-S6-500 in a variety of solid tumors and acute myeloid leukemia, the
ability of AVB-S6-500 to treat cancer, the ability of AVB-S6-500 to
demonstrate safety and efficacy in future clinical trials, as well as
clinical results that are consistent with prior in vitro results and
Phase 1 clinical trial results, the ability to enroll patients and
complete clinical trials on time and achieve desired results and
benefits, our ability to obtain regulatory approvals for
commercialization of product candidates or to comply with ongoing
regulatory requirements, regulatory limitations relating to our ability
to promote or commercialize our product candidates for specific
indications, acceptance of our product candidates in the marketplace and
the successful development, marketing or sale of products, our ability
to maintain our license agreements, the continued maintenance and growth
of our patent estate, our ability to establish and maintain
collaborations, our ability to obtain or maintain the capital or grants
necessary to fund our research and development activities, our ability
to retain our key scientists or management personnel and our ability to
consummate the merger with Versartis, Inc. All forward-looking
statements are based on our expectations and assumptions as of the date
of this press release. Actual results may differ materially from these
forward-looking statements. Except as required by law, we expressly
disclaim any responsibility to update any forward-looking statement
contained herein, whether as a result of new information, future events
or otherwise.

Additional Information and Where to Find It

In connection with the proposed transaction pursuant to the terms of the
Agreement and Plan of Merger and Reorganization, dated as of June 3,
2018, by and among Versartis, Inc., Velo Merger Sub, Inc. and Aravive
Biologics, Versartis filed relevant materials with the Securities and
Exchange Commission, or the SEC, including a registration statement on
Form S-4 that contains a preliminary proxy statement/prospectus.
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
In addition, Versartis and Aravive investors and shareholders will be
able to obtain free copies of the definitive 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 definitive 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 Biologics, 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 the registration
statement on Form S-4 filed with the SEC on August 3, 2018 as well as
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
definitive proxy statement/prospectus relating to the merger when it is
filed with the SEC. These documents can be obtained free of charge from
the sources indicated above. This communication is not intended to and
does not constitute 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.

View Comments and Join the Discussion!