Bioatla Q1 2024 Earnings Report
Key Takeaways
BioAtla reported a net loss of $23.2 million for the first quarter ended March 31, 2024, compared to a net loss of $27.5 million for the same quarter in 2023. The company's cash and cash equivalents were $80.6 million as of March 31, 2024, expected to fund operations into the second half of 2025.
Ozuriftamab vedotin Phase 2 data in SCCHN showed multiple confirmed responses and a manageable safety profile; anticipate FDA meeting for potential registrational trial in 2H 2024.
Evalstotug Phase 1 study progressing well with initial Phase 2 monotherapy data readout on track for 2Q 2024; anticipate FDA meeting for first-line melanoma potential registrational trial in 2H 2024.
Mecbotamab vedotin initial 20 patients in Phase 2 UPS study enrolled; anticipate FDA meeting to discuss the remaining trial portion in 2H 2024.
Cash balance of $80.6 million as of March 31, 2024, is expected to fund operations into 2H 2025.
Bioatla
Bioatla
Forward Guidance
BioAtla anticipates several milestones throughout the remainder of the year, including FDA meetings for potential registrational trials and data readouts from ongoing clinical trials.
Positive Outlook
- Anticipate FDA meeting in 2H 2024 for potential registrational trial in SCCHN for ozuriftamab vedotin.
- Expect to clear DLT observation period at 1 gram (14.2 mg/kg) for evalstotug in 2Q 2024.
- Initial Phase 2 monotherapy data readout for evalstotug is on track for 2Q 2024.
- Currently enrolling first-line melanoma and first-line NSCLC patients at 700 mg in combination with pembrolizumab and in combination with pembrolizumab plus chemotherapy, respectively; on track for data readout in 2H 2024
- Anticipate FDA meeting in 2H 2024 for potential registrational trial in first-line, metastatic or unresectable, BRAF-mutated melanoma for evalstotug.
Challenges Ahead
- Potential delays in clinical and pre-clinical trials.
- Uncertainties inherent in research and development.
- Dependence on the success of the CAB technology platform.
- Reliance on third parties for the manufacture and supply of product candidates.
- Potential adverse impacts due to any resurgence of COVID-19 and its variants.