Company Overview - Aravive is a clinical-stage company developing treatments for life-threatening diseases like cancer and fibrosis[4] - The company has a $20 million Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT)[4] - Multiple milestones are anticipated during 2020 & 2021[4] AVB-500 Clinical Program - AVB-500 is a first-in-class GAS6/AXL signaling pathway blocker[5] - Early proof-of-concept for anti-tumor activity was demonstrated in platinum-resistant ovarian cancer (PROC)[5] - The FDA granted fast-track designation to AVB-500[5] - Aravive completed Phase 1b and plans to initiate a Phase 2/3 trial for platinum-resistant ovarian cancer in 2H20/Q121[5] GAS6/AXL Pathway and AVB-500's Selectivity - AXL overexpression is linked to metastasis, poor survival, and drug resistance in many cancers[11] - AVB-500 has fM affinity to neutralize GAS6[15] - AVB-500 is a selective GAS6 inhibitor, unlike other AXL-targeting drugs in clinical development[16] Phase 1b Study Results - In the Phase 1b study, the RP2D (Recommended Phase 2 Dose) for AVB-500 was determined to be 15 mg/kg[24] - The overall response rate (ORR) in the PAC (paclitaxel) cohort was 35% (8/23), with 8.7% (2/23) achieving complete response (CR)[28] - The overall response rate (ORR) in the PLD (pegylated liposomal doxorubicin) cohort was 15% (4/26)[28] - Patients with trough levels above 13.8 mg/L showed improved clinical benefit[46] - In patients not previously treated with bevacizumab, the ORR with AVB-500 + PAC was 60% (6/10)[59] Planned Phase 2/3 Trial - Aravive is planning a randomized, double-blind, placebo-controlled Phase 2/3 trial to compare the efficacy and tolerability of AVB-500 + PAC versus PAC in platinum-resistant ovarian cancer[65, 66] Financial Status - Aravive has $60 million in cash and cash equivalents[72] - The company expects to fund its current operating plans into 2022 with the current cash, depending on the PROC P2/P3 design[73]
Aravive (ARAV) Investor Presentation - Slideshow