Bioatla (BCAB) Jefferies 2024 Global Healthcare Conference summary

Pipeline and clinical updates

• Focused on conditionally active biologics (CABs) for targeted cancer therapy, with three main programs: CAB CTLA-4, CAB-ROR2, and strategic collaborations.

• CAB CTLA-4 shows encouraging efficacy and safety, with plans to initiate a registrational trial by year-end targeting melanoma, especially BRAF-mutant patients.

• CAB-ROR2 in head and neck cancer has 11 responses out of 29 evaluable patients, with 6 confirmed responses; ongoing FDA discussions for monotherapy and combination therapy.

• AXL ADC mecbotamab vedotin in undifferentiated pleomorphic sarcoma (UPS) is progressing, with FDA meetings planned to confirm an accelerated registrational path.

• Strategic partnership discussions are ongoing, aiming for collaboration in the second half of the year to support clinical development.

Recent data and competitive landscape

• Phase I data for evalstotug (BA3071) presented at ASCO showed durable responses and a favorable safety profile compared to marketed CTLA-4 products.

• Cleared the 1-gram dose level for evalstotug, planning to discuss this with the FDA for pivotal trials in melanoma.

• Competitive landscape at ASCO highlighted the need for safer CTLA-4 regimens; current drug aims to address toxicity issues seen in other triplet therapies.

• Phase II data for ozuriftamab vedotin in head and neck cancer showed 11 responses among 29 evaluable patients, with 6 confirmed, including one complete remission.

• Bar for efficacy in refractory head and neck cancer is a 25% response rate and 4-6 months duration; current data seen as promising for second-line and beyond.

Financials, milestones, and outlook

• Current cash position supports operations into the second half of 2025, aided by reduced expenses as trials wind down.

• Five key drivers for the year: evalstotug monotherapy data, evalstotug/pembro combo data, FDA feedback for three programs, strategic collaboration, and phase I data for a dual CAB EpCAM T-cell engager.

• R&D day planned for mid-July to present new data and updates.

• UPS market opportunity estimated at $500 million peak sales, with potential for label expansion across all soft tissue sarcomas.

• Strategic collaboration remains a top corporate goal to support pivotal trial initiation.