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Aravive, Inc. (Nasdaq: ARAV) is a late clinical-stage oncology company committed to developing targeted therapeutics for the treatment of metastatic diseases. With its headquarters in Houston, Texas, the company is at the forefront of cancer research aiming to improve the quality of life and outcomes for patients battling severe forms of cancer.
The company's lead product candidate, batiraxcept (formerly AVB-500), is an ultra-high affinity decoy protein designed to inhibit AXL receptor signaling by binding to its ligand GAS6. This mechanism is intended to prevent tumor growth and metastasis, as well as to restore sensitivity to existing anti-cancer therapies. Batiraxcept has received Fast Track Designation from the U.S. FDA for both clear cell renal cell carcinoma and platinum-resistant ovarian cancer, along with Orphan Drug Designation from the European Commission for platinum-resistant recurrent ovarian cancer.
Despite recent challenges, such as the Phase 3 AXLerate-OC trial not meeting its primary endpoint in platinum-resistant ovarian cancer, Aravive remains committed to analyzing the complete dataset and determining the next steps for their other indications in renal cell carcinoma and pancreatic cancer. The Phase 3 trial involved 366 patients and aimed to evaluate the efficacy and safety of batiraxcept in combination with paclitaxel.
Aravive collaborates with renowned research groups, including The GOG Foundation, Inc. in the U.S. and the European Network for Gynecological Oncological Trials (ENGOT) in Europe. Funded by a Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT) in 2016, the company continues to innovate in the field of oncology.
For more information on their ongoing research and development efforts, please visit their website at www.aravive.com.
Aravive, Inc. (Nasdaq: ARAV) has announced the presentation of two poster abstracts at the ASCO 2022 Annual Meeting scheduled from June 3-7, 2022. Notably, abstract 4511 will be featured in an oral presentation, highlighting a Phase 1b/2 study of batiraxcept (AVB-S6-500) combined with cabozantinib for advanced clear cell renal cell carcinoma. The second abstract, TPS4599, will be presented as a Trials in Progress poster. Both abstracts focus on innovative treatment approaches for metastatic disease, reinforcing Aravive's commitment to developing targeted oncology therapeutics.
Aravive, Inc. (Nasdaq: ARAV) announced the successful closing of a registered direct offering totaling approximately $10 million. This offering involved the sale of 4,850,241 shares of common stock and an equivalent number of warrants, priced at $2.005 per share for one investor and $2.325 for Eshelman Ventures, LLC. The proceeds are earmarked for the clinical development of batiraxcept in treating platinum-resistant ovarian cancer and clear cell renal cell carcinoma. The offering reflects Aravive's strategic focus on advancing its oncology pipeline.
Aravive, Inc. (Nasdaq: ARAV) reported progress in its clinical trials for batiraxcept, targeting ovarian, kidney, and pancreatic cancers. The company dosed its first patient in the Phase 2 trial for clear cell renal cell carcinoma (ccRCC) in January 2022 and plans to report preliminary data in 2Q’22. Aravive strengthened its financial position with a $20 million investment from Eshelman Ventures and a healthcare-focused investor, enhancing its cash runway into 1Q’23. For 2021, Aravive generated $7.4 million in revenue but reported a net loss of $39.2 million.
Aravive, Inc. (Nasdaq: ARAV) has announced a registered direct offering of 4,850,241 shares of common stock and warrants, raising approximately $10 million. The shares are priced at $2.005 and $2.325 for two investors. The net proceeds will be used for the clinical development of batiraxcept, targeting platinum-resistant ovarian cancer and clear cell renal cell carcinoma. H.C. Wainwright & Co. is the exclusive placement agent. The offering is expected to close on or about March 31, 2022, subject to customary conditions.
Aravive, Inc. (Nasdaq: ARAV) announced the appointment of Scott Dove, Ph.D. as Chief Operating Officer. With over 20 years in drug development, Dr. Dove's experience includes leadership roles at PPD and Allergan. His expertise is expected to be crucial as Aravive progresses through a pivotal year, with significant clinical milestones on the horizon for its lead compound, batiraxcept. Topline data from the Phase 3 trial in platinum-resistant ovarian cancer is anticipated in the second quarter of 2023, making this a vital period for the company's growth and value maximization.
Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology firm, announced that CEO Gail McIntyre will participate in the 34th Annual ROTH Conference on March 14, 2022, at 8:30 am PT. The event will take place at The Ritz Carlton, Dana Point, California. McIntyre and CFO Vinay Shah will also hold one-on-one meetings on the same day. Aravive is advancing treatments targeting metastatic disease, with its lead candidate, batiraxcept, showing promise in clinical trials for ovarian cancer and other cancers. A live webcast of the presentation will be accessible on their website.
Aravive, Inc. (NASDAQ: ARAV) announced promising data from its Phase 1b/2 trial of batiraxcept for clear cell renal cell carcinoma (ccRCC). The trial showed a 46% overall response rate in the intent-to-treat (ITT) population and a 63% response rate in patients with high sAXL/GAS6 biomarkers. A 79% six-month progression-free survival (PFS) rate was observed in the ITT group, while the biomarker high subgroup demonstrated a 91% PFS rate. No dose-limiting toxicities were reported, supporting further investigation of batiraxcept in combination with cabozantinib.
Aravive, Inc. (Nasdaq: ARAV) plans to present updated exposure-response analyses from its Phase 1b trials for platinum-resistant ovarian cancer and clear cell renal cancer at the AACR annual meeting from April 8-13, 2022. The presentation, titled "Exposure-Response Analysis of Batiraxcept and Application to Recommended Phase 2 Dose in Platinum-Resistant Ovarian and Clear Cell Renal Cancers," will be delivered virtually on April 8, 2022. Batiraxcept, an ultra-high affinity decoy protein, targets metastatic disease and has received Fast Track Designation from the FDA.
Aravive, Inc. (Nasdaq: ARAV) has initiated the Phase 2 portion of its Phase 1b/2 study for batiraxcept, targeting clear cell renal cell carcinoma (ccRCC). The first patient has been dosed, and the trial aims for an enrollment of 55 patients across three parts, assessing batiraxcept in combination with existing therapies. Preliminary data indicates promising safety and activity, which supports this advancement. Batiraxcept is also being evaluated in other trials and has received Fast Track and Orphan Drug designations for various indications.
Aravive, Inc. (Nasdaq: ARAV) announced a significant investment from Chairman Fred Eshelman, who agreed to purchase a pre-funded warrant for 4,545,455 shares at $2.20 each, raising approximately $10 million. This infusion bolsters the company's financial position ahead of key clinical milestones in 2022 related to its lead product candidate, batiraxcept, which targets metastatic disease. Eshelman has transitioned to Executive Chairman, enhancing strategic leadership. His ownership of 18.2% may require shareholder approval for warrant exercise if it exceeds 20% of voting power.
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