Loading...
•
Dec 31, 2022
Bioatla Q4 2022 Earnings Report
BioAtla reported financial results for Q4 2022 and highlighted recent progress.
Key Takeaways
BioAtla reported a net loss of $27.5 million for the quarter ended December 31, 2022, compared to a net loss of $23.4 million for the same quarter in 2021. Cash and cash equivalents were $215.5 million as of December 31, 2022.
Cleared dose-limiting toxicity (DLT) observation period with more frequent, dose-intensive regimen of CAB-AXL BA3011; anticipated leiomyosarcoma (LMS) cohort readout in 2H23
Initiated the potentially registrational Phase 2, part 2 BA3011 Undifferentiated Pleomorphic Sarcoma (UPS) study in 1H23 including more frequent, dose-intensive regimens
Achieved First Patient In (FPI) for CAB-ROR2 BA3021 Phase 2 squamous cell carcinoma of the head & neck (SCCHN) study
Cleared DLT observation period for CAB-CTLA-4 (BA3071) 210mg (3mg/kg) Q3W in combination with nivolumab 3mg/kg Q3W; Phase 1 dose-escalation ongoing with data readout and initiation of Phase 2 both anticipated in 2H23
Bioatla
Bioatla
Forward Guidance
BioAtla anticipates several important milestones and value inflection points to be achieved and communicated throughout 2023.
Positive Outlook
- Advancement of Phase 2, part 2 potentially registrational BA3011 trial in NSCLC
- Completion of Phase 2 study for BA3021 in NSCLC enabling FDA discussions regarding a potential registrational trial
- Initiation of a phase 2 trial for BA3071
- Potential additional IND submissions for pre-clinical CAB bispecific and next generation ADC candidates in 2023 through 2024
- Cash balance of $215.5 million at year-end 2022 expected to provide funding into 2025
Challenges Ahead
- Potential delays in clinical and pre-clinical trials due to the global COVID-19 pandemic
- Other potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy
- Uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, or regulatory approval dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data
- Whether regulatory authorities will be satisfied with the design of and results from the clinical studies or take favorable regulatory actions based on results from the clinical studies
- Dependence on the success of our CAB technology platform