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BioAtla(BCAB) - 2025 Q3 - Earnings Call Transcript
2025-11-13 22:30
Financial Data and Key Metrics Changes - As of September 30, 2025, the company reported cash and cash equivalents of $8.3 million, which does not include a recent $2 million milestone payment received in October 2025 [12] - The net loss for the third quarter of 2025 was $15.8 million, an increase from a net loss of $10.6 million in the same quarter of 2024, primarily due to the absence of collaboration revenue recorded in 2024 [12][13] - Research and development (R&D) expenses decreased to $9.5 million in Q3 2025 from $16.4 million in Q3 2024, driven by reduced program development costs and lower headcount-related expenses [13] - General and administrative (G&A) expenses were $4.2 million for Q3 2025, down from $5.9 million in Q3 2024, attributed to reduced personnel costs [14] Business Line Data and Key Metrics Changes - The company is preparing to initiate a phase 3 study for OSV, which has shown promising clinical activity in heavily pretreated patients with HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) [5][7] - The dual CAB, EpCAM, T-cell engager program is progressing well, with preliminary data indicating a manageable safety profile and encouraging signs of tumor reductions across various indications [10] Market Data and Key Metrics Changes - The worldwide peak sales estimate for OSV in second-line and later OPSCC is approximately $800 million, with the total worldwide OPSCC market projected to reach $3 billion by 2032 [7] - The broader HPV-positive solid tumor market, including cervical cancer, is valued at over $7 billion globally [8] Company Strategy and Development Direction - The company is in advanced stages to finalize a strategic transaction with a potential partner by year-end, indicating a focus on collaboration and partnerships [4][5] - The company aims to address critical unmet needs in oncology through its prioritized programs, particularly the dual CAB, EpCAM, TCE program, which has the potential to treat over 1 million adenocarcinoma cancer patients annually [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming phase 3 trial for OPSCC, which addresses a significant unmet need and represents a substantial commercial opportunity [15] - The company anticipates key clinical trial readouts in the first half of next year, with several important events related to its programs throughout 2026 [15] Other Important Information - The company achieved FDA alignment on the phase 3 OSV registrational trial design, which includes dual primary endpoints of overall response rate and overall survival [4][5] - A development milestone was achieved under the license agreement with Context Therapeutics, validating the T-cell engager platform [5] Q&A Session Summary Question: Can you provide details on the patient number for the ROR-2 program's phase 3 study and control arm stratification? - The pivotal trial design for full approval involves approximately 300 patients, with an interim analysis for accelerated approval occurring earlier [18][19] Question: What data can be expected from the 3182 program next year? - The next data output is anticipated in the first half of next year, with comprehensive reporting on additional dose and schedule evaluations [21][22]