Aravive Investor Presentation Deck slide image

Aravive Investor Presentation Deck

Batiraxcept Phase 3 Registrational Trial Design in ccRCC FDA Recommendation: Integrated P2/3 study with interim analyses to look at futility in the biomarker low population and ORR for potential accelerated approval with PFS endpoint for full approval. Full protocol and statistical plan in preparation for submission to FDA. Provides opportunity for accelerated approval and full approval in one study Final PFS analysis conducted in the ITT and the biomarker high population to increase chance for success. Endpoint Assessment: PFS per RECIST V1.1; radiological imaging every 8 weeks N - 360 Key Eligibility Criteria Histologically confirmed metastatic ccRCC Progressed on/after a front-line treatment regimen • Patients who previously were treated with cabozantinib are excluded | ■ ■ ECOG 0-1 Stratifications: IMDC category Prior therapy (10/10 vs 10/TKI) Prior lines of therapy Biomarker Batiraxcept + Cabozantinib 1:1 Randomization Dosing: Batiraxcept 15 mg/kg q 2 weeks + cabozantinib 60mg every day, dosed per package insert Cabozantinib Interim Analyses 6mos after -160 Patients Enrolled Futility ORR in biomarker high population for Accelerated Approval i 1 Endpoints ¹ PFS in the biomarker high population (if low biomarker patients not discontinued for futility) • PFS in the ITT population • OS secondary endpoint • Initiation planned mid'23 BLA= biologics license application, ECOG = Eastern Cooperative Oncology Group (ECOG) Performance Status, IMDC = International Metastatic RCC Database onsortium (Risk), 10 = Immuno-oncology, ITT inte to treat (population), ORR = Overall response rate, PFS-progression-free survival, TKI = tyrosine kinase inhibitor ¹PFS will be assessed by blinded independent central review (BICR) 26
View entire presentation