HOUSTON, Feb. 16, 2021 (GLOBE NEWSWIRE) — Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative therapeutics, today announced that it has entered into a securities purchase agreement with Eshelman Ventures, LLC to sell 2,875,000 shares of common stock at a price of $7.29 per share in a registered direct offering. Aravive expects to receive gross proceeds of approximately $21.0 million from this offering. Eshelman Ventures, LLC is an entity wholly-owned by Fredric N. Eshelman, Pharm.D., chairman of Aravive’s Board of Directors.
“Dr. Eshelman’s support reinforces our confidence in the potential of AVB-500 to address the unmet needs of patients with ovarian and renal cancer,” said Gail McIntyre, Ph.D., chief executive officer of Aravive. “We look forward to initiating the pivotal Phase 3 registrational trial of AVB-500 in platinum resistant ovarian cancer in the coming weeks and reporting on the first interim analysis expected early next year.”
Proceeds from the registered direct offering will be used primarily to continue clinical development of AVB-500 in platinum resistant ovarian cancer and clear cell renal cell carcinoma, and for general corporate purposes. The offering is expected to close on or about February 18, 2021, subject to customary closing conditions.
The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (“SEC”) on September 4, 2020 and declared effective by the SEC on November 20, 2020. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov .
This press release shall not constitute an offer to sell nor the solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Aravive, Inc. is a clinical-stage oncology company developing transformative therapeutics designed to halt the progression of life-threatening diseases. Aravive is based in Houston, Texas and received a Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT) in 2016. Aravive’s lead product candidate, AVB-500, is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth. Aravive successfully completed a Phase 1b trial of AVB-500 in platinum resistant ovarian cancer and plans to initiate a pivotal Phase 3 trial of AVB-500 at a dose of 15 mg/kg. While the Phase 1b trial of AVB-500 in platinum resistant ovarian cancer was a safety trial and not powered to demonstrate efficacy, all 5 patients in the 15 mg/kg cohort experienced clinical benefit, with 1 complete response, 2 partial responses, and 2 stable disease. The Company has initiated and is recruiting for its Phase 1b/2 trial in patients with clear cell renal cell carcinoma.
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions and includes statements regarding the timing, closing and use of proceeds of the registered direct offering, the timing of the initiation and reporting of the results of the pivotal Phase 3 registrational trial of AVB-500 in platinum resistant ovarian cancer and the potential of AVB-500 to address the unmet needs of patients with ovarian and renal cancer. Forward-looking statements are based on current beliefs and assumptions, are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those contained in any forward-looking statement as a result of various factors, including, but not limited to, risks and uncertainties related to: our ability to recruit patients for a Phase 1b/Phase 2 trial of AVB-500 in clear cell renal cell carcinoma as planned, our ability to initiate a Phase 3 trial of AVB-500 in platinum-resistant carcinoma as planned, the impact of COVID-19 on the Company’s clinical strategy, clinical trials, supply chain and fundraising, the Company’s ability to expand development into additional oncology indications, the Company’s dependence upon AVB-500, AVB-500’s ability to have favorable results in clinical trials and ISTs, the clinical trials of AVB-500 having results that are as favorable as those of preclinical and clinical trials, the ability to receive regulatory approval, potential delays in the Company’s clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients especially in light of the COVID-19 pandemic; the risk that AVB-500 may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that the Company may encounter difficulties in manufacturing AVB-500; if AVB-500 is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing the Company’s intellectual property rights; the Company’s reliance on its licensor of intellectual property and financing needs. 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 the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, recent Current Reports on Form 8-K and subsequent filings with the SEC. Except as required by applicable law, the Company 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.
Sheryl Seapy, W2O
Luke Heagle, W2O