Release Date: May 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- BioAtla Inc (BCAB, Financial) reported encouraging data readouts for CAB-ROR2 ADC in treatment-refractory head and neck cancer patients, with a 38% response rate and an 86% disease control rate.
- The company's CAB-CTLA-4 IO antibody showed promising safety results, allowing dose escalation to 700 mg and planning for a 1 gram dose, indicating potential for maximum activity in tumor environments.
- BioAtla Inc (BCAB) completed dosing in the first portion of a potentially registrational trial in undifferentiated pleomorphic sarcoma and plans to evaluate targeting prostate cancer patients.
- Financially, BioAtla Inc (BCAB) reported a decrease in R&D expenses due to the completion of certain preclinical developments and prioritization of clinical programs.
- BioAtla Inc (BCAB) has sufficient cash and cash equivalents to fund operations into the second half of 2025, providing stability for ongoing and planned clinical trials.
Negative Points
- The CAB-ROR2 ADC did not meet the internal efficacy bar for melanoma, leading to a decision not to explore more intensive regimens at this time.
- One patient discontinued treatment due to a treatment-related adverse event of peripheral neuropathy during the safety data cut in March.
- Despite the decrease in R&D expenses, the company reported a net loss of $23.2 million for the quarter ended March 31, 2024.
- Net cash used in operating activities increased in the first quarter of 2024 compared to the same period in 2023, indicating higher cash burn rates.
- The company faces the challenge of needing further follow-up to estimate the duration of response for its CAB-ROR2 ADC in head and neck cancer, which is critical for assessing long-term efficacy.
Q & A Highlights
Q: Can you elaborate on the duration of the confirmed responses that you're seeing with your CAB-AXL ADC in head and neck cancer today?
A: (Sheri Lydick, Chief Commercial Officer) We need further follow-up to estimate our duration of response accurately. However, the swimmer's plot on slide 29 of our corporate presentation gives a sense of the confirmed responses, particularly in patients treated with every other week dosing.
Q: Can you help us frame the expectation of response level and also the duration of response with the current standard of care in head-and-neck cancer today in second line or third line?
A: (Sheri Lydick, Chief Commercial Officer) In later lines, such as the fourth line where our study is positioned, the bar is exceptionally low. In the second line, the average response rate is around 13%, and you would expect a duration of about five months or more. Given the late lines we're in, the data is encouraging.
Q: Can you provide any color on the median follow-up that you might need before you meet with the FDA in the second half? And also, do you expect to start the next stage of recruiting in 2024 or it could be in early 2025?
A: (Sheri Lydick, Chief Commercial Officer) We've completed the dosing intended for the first portion of the potentially registrational trial. We aim to achieve multiple scans for each patient in the second half of this year, assuming continued encouraging data, which could allow us to start the next portion of the trial in late 2024.
Q: What feedback have you received from physicians on the CAB-AXL ADC data in head and neck cancer? Were there any patients who had seen any other ADC as a prior line of therapy?
A: (Richard Waldron, CFO) Feedback from physicians has been very positive, highlighting the tolerability and rapidity of response. There were no specific mentions of patients who had received other ADCs as prior therapy in the data reviewed.
Q: Regarding the CTLA-4 program, could you give us more details on the cancer types for the 20 patients in the monotherapy trial and the median cycle number of patients receiving the drug?
A: (Richard Waldron, CFO) The monotherapy trial included a broad range of melanomas and relapsed refractory carcinomas. We have treated three patients at the one gram dosing level, and we are looking forward to presenting more detailed results soon.
Q: For the CTLA-4 program, do you anticipate that the combination with pembrolizumab at one gram will have sufficient duration for you to make a decision about moving forward with the BRAF mutated melanoma study?
A: (Richard Waldron, CFO) Yes, we believe we will have sufficient follow-up to make informed decisions. We are currently dosing first-line patients without regard to BRAF mutation to gain additional experience at this dose level.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
