Positive Preliminary Data from Phase 1b Trial Evaluating Batiraxcept (AVB-500) in Combination with Cabozantinib for Treatment of Clear Cell Renal Cell Carcinoma

• 7 of 16 (44%) patients achieved best overall response of partial response
• Confirmed response in 5 of 7 (71%) patients who had at least 16 weeks of follow-up
• 14 of 16 (88%) patients demonstrated tumor decrease from baseline
• Batiraxcept has been well-tolerated with no dose-limiting toxicities

“We are encouraged by batiraxcept's early profile in patients with clear cell renal cell carcinoma,” said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. “The current response rate of batiraxcept in combination with cabozantinib is encouraging. Cabozantinib alone produces response rates between 17-28% in a similar population. In heavily pretreated patients, batiraxcept demonstrates clinical activity across the 15 mg/kg and 20 mg/kg doses with a tolerable safety profile. These results reinforce our confidence in the potential of batiraxcept to improve outcomes across multiple types of cancer by targeting the GAS6/AXL signaling pathway. We look forward to initiating the Phase 2 trial in the fourth quarter of 2021 and building on these promising data.”

• Analysis of all safety data demonstrates that batiraxcept has been well-tolerated with no dose-limiting toxicities.
• There have been no batiraxcept-related serious adverse events reported to date.
• There were no batiraxcept-related Grade 4 or 5 adverse events.
• 3 patients experienced Grade 3 adverse events considered by the investigator as potentially being related to both batiraxcept and cabozantinib.
  • At the batiraxcept 15 mg/kg dose, 1 patient experienced transient hypertension and 1 patient experienced transient thrombocytopenia. Both events resolved while still receiving batiraxcept.
  • At the batiraxcept 20 mg/kg dose, 1 patient experienced a thromboembolic event, small bowel obstruction, abdominal pain and vomiting. The bowel obstruction, abdominal pain and vomiting resolved while the patient continued batiraxcept treatment.
  • All events are known adverse events associated with cabozantinib use.

• PK analyses indicate that batiraxcept trough levels were above the minimally efficacious concentration (MEC) of 13.8 mg/L prior to cycle 2 day 1 in the first 10 efficacy-evaluable patients.

• Best overall response of partial response was observed in 7 of 16 (44%) evaluable patients across both dose levels. 9 of 16 (56%) patients had a best overall response of stable disease. No patients had progressive disease at their first radiological exam.
• 7 of 16 patients have had at least 16 weeks of follow up (at least two post-baseline radiological exams). 5 of the 7 (71%) patients have confirmed partial responses and 2 of the 7 (29%) patients achieved confirmed stable disease.
• 88% (14/16) of patients had tumor decrease from baseline.
• 4 patients had 1 or more target lesions completely disappear. 3 patients were treated with batiraxcept 15 mg/kg and cabozantinib and 1 patient was treated with batiraxcept 20 mg/kg and cabozantinib.
• 2 patients had target lesions decrease from baseline by more than 76%. 1 patient was treated with batiraxcept 15 mg/kg and 1 patient was treated with batiraxcept 20 mg/kg.
• This clinical activity was observed despite cabozantinib dose reductions with median cabozantinib dose intensity of 41 mg (68% of 60 mg prescribed dose).

• Title: A Phase 1b/2 randomized study of AVB-S6-500 in combination with cabozantinib versus cabozantinib alone in patients with advanced clear cell renal cell carcinoma who have received front-line treatment
• Presenter: Reshma Rangwala, M.D., Ph.D., Chief Medical Officer of Aravive
• Date: November 13, 2021
• Time: 7:00 a.m. – 8:30 p.m. ET
• Location: Hall E