GAS6

Earlier this week, Aravive, a late-stage oncology company creating targeted therapies for advanced metastatic diseases, this week that it would be letting go of approximately 70% of its existing workforce. The decision came on the heels of the phase 3 AXLerate-OC trial results, where the investigational drug batiraxcept failed to meet its primary endpoint of progression-free survival for platinum-resistant ovarian cancer patients. The trial also no distinction in outcomes across the broader patient population, including those who had previously undergone bevacizumab treatment. The company's lead , batiraxcept is an ultra-high affinity decoy protein that binds to GAS6 and thereby prevents AXL signaling to inhibit metastasis and tumor growth and restore sensitivity to anti-cancer agents. The treatment has been granted Fast Track Designation by the U.S. FDA for both clear cell renal cell carcinoma and platinum-resistant ovarian cancer and Orphan Drug Designation for pancreatic ductal adenocarcinoma. In an effort to navigate the financial challenges that lay ahead, Aravive’s board of directors gave the green light to the layoffs. Aravive estimates that severance payments to departing employees will amount to about $900,000. Additionally, there's an expected expenditure of $300,000 to cover previously accrued paid time off. These financial outlays, totaling around $1.2 million, are anticipated to be mainly disbursed during the third quarter of fiscal year 2023. As the biotech grapples with these changes, it is actively exploring strategic alternatives to secure its future. These alternatives include seeking strategic partners or financing opportunities. But if Aravive doesn't secure the necessary capital or establish a strategic partnership promptly, it could be forced to halt its operations, liquidate its assets, and potentially enter bankruptcy proceedings. Other biotechs like Illumina and have recently announced layoffs as well. Illumina,a market leader in DNA sequencing equipment and has approximately 10,000 employees, also to close its San Diego facility.

Cash at the end of Q2 of approximately $18M (unaudited) is expected to be sufficient to fund operations into early Q4 2023 Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today announced that its Phase 3 AXLerate-OC trial evaluating the safety and efficacy of batiraxcept in platinum-resistant ovarian cancer did not meet its primary endpoint of progression-free survival (PFS) in the pre-specified subset of patients naïve to prior bevacizumab treatment. The trial did not show any difference between the two arms in the overall population (which included patients previously treated with bevacizumab). The Company will continue to evaluate the complete dataset and determine next steps in the development of batiraxcept. “We are conducting additional analyses on the AXLerate-OC Phase 3 trial to further evaluate the results of this study and determine the best path forward with our two other planned indications in renal cell carcinoma and pancreatic cancer,” said Gail McIntyre, Ph.D., DABT, Aravive’s President and Chief Executive Officer. “We want to thank the patients who participated in this trial, the clinical investigators, and the Aravive team for their hard work, as we continue to pursue our goal of finding innovative cancer treatments for patients in need. Key Findings from AXLerate-OC Study AXLerate-OC enrolled 366 patients, and randomization was stratified for prior bevacizumab treatment; 50% of patients received bevacizumab prior to study entry. The statistical analysis plan called for a hierarchical approach for the assessment of PFS first in the bevacizumab-naïve population and then in the overall cohort of patients. In the bevacizumab-naïve population (n=179), the median PFS in the batiraxcept plus paclitaxel arm was 5.4 months, compared to 5.4 months in the paclitaxel arm. In the overall population, the median PFS in the batiraxcept plus paclitaxel arm was 5.1 months, compared to 5.5 months in the paclitaxel arm. None of these differences were statistically different. The safety profile of batiraxcept was as expected from previous studies. No new safety signals were identified. “Although AXLerate-OC did not meet the primary endpoint, I look forward to working with Aravive to analyze the Phase 3 data and determine the most appropriate path to bring batiraxcept to those patients who may benefit most,” said Dr. Katherine Fuh, Associate Professor, UCSF Division of Gynecologic Oncology. About the Phase 3 PROC Trial The global, randomized, double-blind, placebo-controlled adaptive trial (GOG-3059/ENGOT OV-66) is designed to evaluate efficacy and safety of batiraxcept at a dose of 15 mg/kg in combination with paclitaxel. The trial enrolled 366 patients with high-grade serous ovarian cancer who have received one to four prior lines of therapy at approximately 165 sites in the U.S. and Europe. The primary endpoint for the trial is progression free survival and the secondary endpoint is overall survival. Exploratory endpoints include objective response rate, duration of response, quality of life, clinical benefit rate, pharmacokinetic and pharmacodynamic profile, and sAXL/GAS6 ratio. This trial was conducted in partnership with The GOG Foundation, Inc. (GOG-F), through the GOG Partners program in the USA and in partnership with the European Network for Gynecological Oncological Trial (ENGOT) groups in Europe. The Phase 3 trial is listed on clinicaltrials.gov NCT04729608. About Aravive Aravive, Inc. is a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease. Batiraxcept (formerly AVB-500), is an ultra-high affinity decoy protein that binds to GAS6, the sole ligand that activates AXL, thereby inhibiting metastasis and tumor growth, and restoring sensitivity to anti-cancer agents. Batiraxcept has been granted Fast Track Designation by the U.S. FDA for both clear cell renal cell carcinoma and platinum-resistant ovarian cancer and Orphan Drug Designation by the European Commission in platinum resistant recurrent ovarian cancer. The Company is based in Houston, Texas and received a Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT) in 2016. Additional information at www.aravive.com. The content above comes from the network. if any infringement, please contact us to modify.

Aravive ended the second quarter with $18 million in cash. Aravive’s phase 3 ovarian cancer trial has bombed, taking another chunk out of its share price. And, with cash down to $18 million at the end of the second quarter, the biotech has a matter of months to find a way out of its predicament.  The phase 3 trial enrolled 366 patients with platinum-resistant ovarian cancer. Half of the participants had taken Roche's Avastin before joining the trial. Patients received the chemotherapy paclitaxel or Aravive’s decoy protein batiraxcept plus paclitaxel. Aravive assessed progression-free survival (PFS) in Avastin-naive patients before analyzing the overall trial population.  Neither analysis painted batiraxcept in a positive light. In the bevacizumab-naive subgroup, PFS was the same, 5.4 months, in the batiraxcept and paclitaxel arms. Batiraxcept performed numerically worse than paclitaxel in the overall study population, with its median PFS clocking in at 5.1 months compared to 5.5 months in the control cohort. No new safety signals were identified.  Aravive is still evaluating the phase 3 data. The review will inform the next steps, which were supposed to include the initiation of a phase 3 trial in clear cell renal cancer in the second half of 2023. The failure in the lead indication has created uncertainty. “We are conducting additional analyses on the AXLerate-OC phase 3 trial to further evaluate the results of this study and determine the best path forward with our two other planned indications in renal cell carcinoma and pancreatic cancer,” Aravive CEO Gail McIntyre, Ph.D., said in a statement. Phase 1b/2 data on batiraxcept in pancreatic adenocarcinoma are due soon.  Aravive is running out of time. The biotech ended the second quarter with $18 million in cash, a sum it expects to fund operations until early in the fourth quarter. Batiraxcept is the only drug candidate in Aravive’s pipeline. The biotech bet its future on the candidate in the belief it represented a $3 billion revenue opportunity. The belief was underpinned by evidence that batiraxcept could improve outcomes in three indications by mimicking the AXL receptor and inhibiting the AXL/GAS6 pathway.