Vivesto (VIVE) Status Update summary

Strategic focus and transformation

• Shifted from broad R&D to a focused oncology-driven biotech, targeting both human and veterinary medicine with advanced delivery technologies.

• Dual-track strategy in human and veterinary oncology offers multiple value creation paths and positions the company at an inflection point.

• Strong ownership backing and operational discipline support sustainable growth and scientific impact.

Project portfolio and clinical progress

• Paccal Vet (dogs): Ongoing pilot study in hemangiosarcoma shows median survival nearly doubled to 138 days, with positive interim results; top-line data expected Q2 2026.

• Positive interim results show Paccal Vet extends overall survival in dogs with Stage I-II splenic hemangiosarcoma after splenectomy compared to historical controls; 11 dogs included in interim analysis, 13 enrolled out of 18 required, at eight clinical sites in the US.

• Paccal Vet (cats): Dose-finding study underway, with promising tolerability and early clinical responses; top-line data expected H1 2026.

• Cantrixil: Preclinical studies in AML and other hematological cancers show strong effects, including synergy with standard of care agents and efficacy in resistant cell lines and animal models.

• Apealea: Licensed to Shida Pharma for China, with future milestones and royalties anticipated after regulatory and production steps.

Market opportunity and commercial strategy

• Veterinary oncology market is rapidly growing, driven by pet humanization, willingness to pay, and limited competition; estimated $40B annual growth in companion animal health.

• Paccal Vet targets a large market, with 1 in 3 dogs developing cancer and pricing benchmarked at $3,000–$3,500 per treatment.

• Cantrixil addresses a $3.7B AML market with high unmet need, especially in relapsed/refractory patients; potential pricing aligned with leading therapies.

• No approved drugs exist for splenic hemangiosarcoma in dogs post-splenectomy; human drugs are used off-label.

• Paccal Vet uses proprietary XR-17 technology, improving solubility and reducing side effects compared to traditional formulations.