BCAB

Key Points - Jay M. Short:

• In advanced stages to finalize a strategic transaction by year-end.
• Achieved FDA alignment on the phase three OSV registrational trial design for OPSCC, including dosing regimen, comparator arm, and approval endpoints.
• Achieved a development milestone under the license agreement with Context Therapeutics related to the dual CAB Nectin 4 TCE program.

Eric L. Sievers:

• OSV phase two data showed an overall response rate of 45% and a median overall survival of 11.6 months in late-line patients.
• Dual CAB EpCAM T cell engager presented preliminary data at ESMO with manageable safety profile and signs of tumor reductions.
• MEKV phase two trial in soft tissue sarcomas showed median overall survival of 21.5 months, consistent with prolonged overall survival in mutant KRAS non-small cell lung cancer.

Sheri Lydick:

• OPSCC is a steadily growing indication with up to 80% of cases in the US caused by HPV, projected to be the most common subtype of head and neck cancer in the US by 2030.
• Estimated worldwide peak sales of OSFI to be approximately $800 million in second-line and later OPS alone, with the total worldwide OPSCC market projected to reach $3 billion by 2032 and the broader HPV-positive solid tumor market exceeding $7 billion globally.

- BioAtla expects to see key clinical trial readout in 2026 for the dual CAB EpCAM T cell engager program.

- Preparing for initiation of the OSV phase three study and remains on track to advance this program, aiming to initiate early next year.

As of 09/30/2025, BioAtla, Inc. had $8.3 million in cash and cash equivalents. For the third quarter ended 09/30/2025, the net loss was $15.8 million compared to a net loss of $10.6 million in the same quarter of 2024. Research and development (R&D) expenses were $9.5 million for the quarter ended 09/30/2025, down from $16.4 million in the same quarter of 2024. General and administrative (G&A) expenses were $4.2 million for the quarter ended 09/30/2025, compared to $5.9 million in the same quarter of 2024.

- Statements made during the call include forward-looking statements subject to various risks and uncertainties, such as risks related to clinical trial results, regulatory approval path, sufficiency of cash and cash equivalents, and R&D and G&A expenses. These risks and uncertainties are described in BioAtla's filings with the SEC, including the most recent quarterly report on Form 10-Q and other subsequent filings.

Q: For the ROR2 program, could you give more color around the patient number side by the agency to getting an accelerated approval readout there and about stratification in the control arm?

A: Eric L. Sievers responded that for full approval, approximately 300 patients prospectively randomized and stratified are looked at, and for accelerated approval, it's an interim analysis earlier. Stratification factors include P16 and local regional disease.

Q: For the 3182, could you tell us about the data readout expected next year?

A: Eric L. Sievers stated that they anticipate data output in the first half of next year, with comprehensive reporting on additional dose and schedule evaluations over the next few months.