– Tolerability and proof-of-mechanism for lead candidate AVB-S6-500, a novel GAS6-AXL pathway inhibitor, established in ongoing Phase 1 clinical study

– Multi-study clinical development program in combination with standard of care therapies in tumor types overexpressing GAS6-AXL expected to begin in H2 2018, initially in patients with ovarian cancer

MENLO PARK, CA and HOUSTON, TX, USA I June 04, 2018 I 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.

SOURCE: Versartis