Financial Data and Key Metrics Changes - Cash and cash equivalents as of September 30, 2023, were 215.5 million as of December 31, 2022, with expectations to fund operations into the second half of 2025 [20] - Research and development expenses for Q3 2023 were 19.8 million in Q3 2022, primarily due to clinical product development expenses [20] - General and administrative expenses were 6.3 million in Q3 2022 [21] - Net loss for Q3 2023 was 25.8 million in Q3 2022 [21] Business Line Data and Key Metrics Changes - BA3011 Phase II study in non-small cell lung cancer showed an objective response rate of 27.8% among patients previously treated with PD-1 therapy [7] - In patients with EGFR wild-type, non-squamous lung cancer, 33.3% had a partial response to BA3011 monotherapy [7] - BA3021, a CAB-ROR2-ADC, completed enrollment of approximately 20 patients in both lung cancer and melanoma studies, with early responses observed [11] Market Data and Key Metrics Changes - AXL expression in lung cancer is associated with poor prognosis, with patients in the study having a median of three prior lines of therapy [8] - The company is exploring the potential clinical benefits of BA3011 in AXL TmPS negative patients, which could broaden market opportunities [8] Company Strategy and Development Direction - The company aims to form strategic collaborations with major pharmaceutical partners to accelerate the development of selected assets [6] - Focus remains on delivering innovative therapies to cancer patients with significant unmet medical needs, particularly through the CAB platform [10] Management's Comments on Operating Environment and Future Outlook - Management received verbal FDA feedback supportive of a registrational path for BA3011 in lung cancer, with formal written feedback expected soon [26] - The company believes that the CAB platform demonstrates compelling clinical efficacy and safety across multiple therapeutic targets [23] Other Important Information - Dr. Bin Zhang joined as Senior Vice President, Head of Clinical Development and Operations, bringing over 20 years of experience in oncology drug development [18] - An abstract on BA3011 was accepted for presentation at the IASLC conference in December [19] Q&A Session Summary Question: Feedback on registrational path for BA3011 - Management received clear and actionable items from the FDA regarding the registrational path and expects to communicate more details in December [26] Question: Details on IASLC conference presentation - A standard poster presentation will include data sets, including spider plots and swimmers plots, with updates on combination therapy and more frequent dosing data [28][29] Question: Competition in non-small cell lung cancer - Management noted that responses at low AXL expression levels hint at broader market opportunities, with ongoing evaluations of AXL negative patients [33][35] Question: Data sharing for non-small cell lung cancer - Management confirmed that data on non-small cell lung cancer will be shared at an upcoming meeting, with a focus on prioritizing AXL lung for that indication [37] Question: Enrollment status for bispecific candidate BA3182 - Enrollment is progressing well, with the study actively dosing and showing positive early results [43]
BioAtla(BCAB) - 2023 Q3 - Earnings Call Transcript