Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- BioAtla Inc (BCAB, Financial) reported promising clinical trial results for its drug candidate, Tab war 2 80 C Zy A THEIN, showing a total of 11 responses out of 29 evaluable patients with refractory head and neck cancer.
- The drug candidate received fast track designation from the FDA, highlighting its potential in addressing unmet medical needs.
- BioAtla Inc (BCAB) observed a median overall survival of approximately nine months in heavily pretreated head and neck cancer patients, which is competitive compared to current standard treatments.
- The company received supportive feedback from the FDA for its proposed pivotal trial design, potentially leading to accelerated marketing authorization.
- BioAtla Inc (BCAB) reported a significant decrease in research and development expenses, reflecting efficient prioritization of clinical programs and completion of preclinical development for certain assets.
Negative Points
- BioAtla Inc (BCAB) reported a net loss of $10.6 million for the quarter, despite recognizing $11 million in collaboration revenue.
- The company's cash and cash equivalents decreased significantly from $111.5 million at the end of 2023 to $56.5 million as of September 30, 2024.
- There is uncertainty regarding the sufficiency of cash to fund operations beyond early 2026, despite current projections.
- The company is still in the process of determining the most efficient path for a future pivotal trial for its cab actual A DC asset MBOM, indicating potential delays.
- BioAtla Inc (BCAB) is engaged in ongoing discussions for collaborations, which may impact timelines and resource allocation for its phase two assets.
Q & A Highlights
Q: Can you clarify if the focus for your pivotal trial remains on first-line BRAF mutated melanoma, and what are the patient enrollment criteria?
A: We initially identified BRAF mutated melanoma patients as a focus due to their unique benefit from CTLA-4 blockade. However, we have expanded our focus to include all first-line unresectable and metastatic melanoma patients. Our data shows tumor reductions in all eight patients treated, including those with BRAF mutations, supporting a broader patient population for the pivotal trial.
Q: How will you deploy your cash position as you move two programs into pivotal studies?
A: We plan to take one program forward ourselves and partner with another. We have sufficient capital to finalize dose optimization under Project Optimist, particularly for CTLA-4, and to keep all activities moving efficiently.
Q: Regarding the feedback for the Roar Two and CTLA-4 programs, what are the investigator treatment options and potential study start times?
A: For Roar Two, the investigator treatment options include cetuximab, docetaxel, or methotrexate. We anticipate starting both programs in 2025, with Roar Two ahead of CTLA-4. We are refining the timing as we progress.
Q: In the Roar Two frontline study, what is the total patient number needed, and how does it compare to previous trials like CheckMate 067?
A: We anticipate about 570 patients for the full approval endpoint of overall survival, with a smaller earlier look for accelerated approval based on response rate. This is smaller than the CheckMate 067 trial, which had 945 patients across three arms.
Q: For the RR Two program, will the limited randomized evaluation for dosing schedules be integrated into the pivotal study?
A: The FDA wants to see results from the limited randomized evaluation of dosing schedules. We see this as part of the phase three trial, but we need formal agreement from the agency on the dose once we present the data.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
