BioAtla, Inc. Q3 FY2024 earnings call

• Clinical program updates:
  • Ozuriftamab vedotin in head and neck cancer: 29 evaluable patients had 11 responses, 6 confirmed; median duration of response 4.4 months, median overall survival ~9 months; granted Fast Track designation; FDA supportive of pivotal trial design.
  • Evalstotug in melanoma: Phase II study in first-line unresectable/metastatic melanoma; 8 patients treated achieved tumor reduction; 4 responders including 3 partial and 1 complete response; FDA guidance received for Phase III trial.
  • Mecbotamab vedotin in NSCLC: Evaluable patients with MK-RAS variants showed antitumor activity; median overall survival 12.6 months vs 8.7 months for wild-type; manageable safety profile.
  • CAB-EpCAM T cell engager: Phase I/II dose escalation progressing; maximally tolerated dose not reached; data readout expected mid-2025.
  • License agreement with Context Therapeutics: Out-licensed preclinical asset; focus on lead clinical care programs.

Research and development expenses for Q3 2024 were $16.4 million, down from $28.4 million in Q3 2023 due to completion of preclinical development for Nectin-4 ADC and prioritization of clinical programs. General and administrative expenses were $5.9 million in Q3 2024, down from $6.6 million in Q3 2023, primarily due to lower stock-based compensation. Net loss for Q3 2024 was $10.6 million, compared to a net loss of $33.3 million in Q3 2023. Cash and cash equivalents as of September 30, 2024, were $56.5 million. Revenue was recognized from the exclusive worldwide license agreement with Context Therapeutics, with up to $133.5 million in aggregate payments including $15 million in upfront and near-term milestone payments.

• Cash and cash equivalents expected to fund operations into early 2026, sufficient to complete dose optimization for ROR2 and CTLA4 programs and maintain near-term guidance for strategic collaboration with at least one Phase II asset.
  • Goal to take one Phase II program in-house and one through a partner.

Forward-looking statements subject to various risks, assumptions, and uncertainties described in SEC filings, including risks related to clinical trial outcomes, regulatory approval, cash sufficiency, and R&D expenses.

Q: Regarding focus on first-line BRAF mutated melanoma for pivotal trial and patient enrollment criteria.

A: Eric Sievers stated they expanded to all first-line unresectable and metastatic melanoma, including BRAF mutated, with 8 patients in study experiencing tumor reductions.

Q: How will cash be deployed into moving two programs into pivotal studies?

A: Jay Short mentioned maintaining guidance on near-term Phase 2 collaboration, with capital to handle dose optimization for CTLA4 and other activities.

Q: Feedback on ROR2 and CTLA programs, including time to study start and dose for melanoma.

A: Eric Sievers discussed ROR2 limited randomized evaluation of dosing schedules and dose response in CTLA4 with project optimis.

Q: ROR2 limited randomized evaluation of Q2W and 2Q 3W dosing schedule integration into pivotal study.

A: Eric Sievers said it's part of the Phase III with agency agreement on dose and evaluating schedules.

Q: Cash position including upfront payment from Context.

A: Richard Waldron said cash position includes the upfront payment and is sufficient to carry into 2026 with collaboration discussions.