Bioatla Announces Q2 2024 Financial Results and Recent Progress
BioAtla, Inc., a global clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors, has released its financial results for the second quarter ending June 30, 2024, along with updates on its clinical programs.
Jay M. Short, Ph.D., Chairman, CEO, and co-founder of BioAtla, expressed satisfaction with the progress across the company's CAB portfolio, highlighting positive clinical responses and a notable safety profile in their Phase 2 assets. The FDA granted Fast Track Designation for ozuriftamab vedotin, which targets recurrent or metastatic head and neck cancer (SCCHN), and a meeting with the FDA is anticipated this year. Evalstotug demonstrated a low incidence and severity of immune-related adverse events in both Phase 1 and 2 studies, suggesting it could be a leading CTLA-4 antibody for treating multiple solid tumors. Additionally, mecbotamab vedotin showed promising results in NSCLC patients with KRAS mutations, hinting at potential overall survival benefits.
Key clinical developments include:
Ozuriftamab Vedotin (CAB-ROR2-ADC):
- Phase 2 trials for treatment-refractory SCCHN (NCT05271604) show 11 responses out of 29 evaluable patients across different dosing schedules.
- Fast Track Designation granted by the FDA, with data set to be presented at the European Society for Medical Oncology (ESMO) in September.
Evalstotug (CAB-CTLA-4 Antibody):
- Phase 1 and 2 trials (NCT05180799) showed a low rate of severe immune-related adverse events, with confirmed responses when combined with PD-1 inhibitors.
- No dose reductions occurred, and multiple patients have remained on therapy without progression for over a year.
- Data presentations are scheduled for the Society for Melanoma Research Congress in October and the Society for Immunotherapy of Cancer in November.
- Ongoing Phase 2 enrollment for first-line melanoma and NSCLC patients combined with pembrolizumab.
Mecbotamab Vedotin (CAB-AXL-ADC):
- Phase 2 trial in NSCLC (NCT04681131) showed anti-tumor activity in patients with KRAS mutations, including G12A, G12C, and G12V variants.
- Subgroup analysis revealed that AXL expression of ≥1% correlated with anti-tumor activity.
- One patient with a KRAS G12C mutation experienced a complete response for over two years.
CAB-EpCAM x CAB-CD3 T-cell Engager (BA3182):
- Phase 1/2 dose-escalation trial (NCT05808634) is ongoing and progressing, with a data readout expected in the second half of 2024.
Financial Performance:
- Research and development expenses dropped to $16.2 million, primarily due to the completion of pre-clinical development for Nectin-4 ADC and prioritization of clinical programs.
- General and administrative expenses decreased slightly to $5.8 million.
- The net loss for the second quarter was $21.1 million, down from $35.8 million in the same period last year.
- Cash and cash equivalents stood at $61.7 million, projected to fund operations through the third quarter of 2025.
The company remains on track to deliver multiple clinical readouts and position its programs for potentially registrational trials while continuing strategic collaboration discussions. BioAtla's management will host a conference call and webcast to discuss these results further.
BioAtla continues to develop innovative CAB-based therapies targeting various solid tumors, leveraging its proprietary technology to create more efficacious and safer treatment options, including ozuriftamab vedotin, evalstotug, mecbotamab vedotin, and BA3182. The company is also progressing with its next-generation CAB-Nectin4-ADC, BA3361.
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