BioAtla, Inc. (NASDAQ:BCAB) is a global clinical-stage biotechnology company at the forefront of developing Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors. The company's innovative approach has positioned it as a leader in the field of targeted cancer therapies, with a diverse pipeline of promising drug candidates poised to transform the landscape of cancer care.
Business Overview and History
Founded in March 2007 as BioAtla, LLC, a Delaware limited liability company, BioAtla has established itself as a pioneer in the development of CAB technology, which allows for the selective activation of therapeutic antibodies in the tumor microenvironment. In July 2020, the company was converted to a Delaware corporation and renamed BioAtla, Inc. This groundbreaking platform has enabled the company to create a robust pipeline of CAB-based product candidates, each designed to tackle specific cancer targets with increased precision and reduced off-target effects.
Since its inception, BioAtla has focused substantially all of its resources on conducting research and development activities, including drug discovery, preclinical studies and clinical trials of its product candidates. This has included the ongoing Phase 2 clinical trials of mecbotamab vedotin (BA3011), ozuriftamab vedotin (BA3021), and evalstotug (BA3071), as well as the Phase 1 clinical trial of BA3182 CAB-EpCAM x CAB-CD3. The company has also worked to establish and maintain its intellectual property portfolio, manufacturing capabilities, and key personnel and collaborations.
Throughout its history, BioAtla has faced various challenges common to clinical-stage biotechnology companies. These have included delays in enrollment and completion of clinical trials, manufacturing issues, and regulatory uncertainties. The company has worked to navigate these obstacles through careful planning, strategic decision-making, and the development of its core CAB technology platform. BioAtla's ability to advance its pipeline and reach key milestones has been critical to its progress as a clinical-stage biopharmaceutical company.
Financial Overview
As a clinical-stage biotechnology company, BioAtla has yet to generate significant revenues from product sales. However, the company has demonstrated strong financial discipline, managing its cash resources effectively to support its research and development efforts. As of December 31, 2023, BioAtla reported a cash and cash equivalents balance of $111.5 million, providing a solid foundation to advance its pipeline.
The company's financial performance has been marked by consistent annual net losses, a common trend in the biotechnology industry as companies focus on research, development, and clinical trials before reaching commercialization. In the fiscal year ended December 31, 2023, BioAtla reported a net loss of $123.5 million, compared to a net loss of $106.5 million in the previous year. This reflects the company's ongoing investment in its pipeline and the inherent challenges of developing novel therapeutic approaches.
For the nine months ended September 30, 2024, BioAtla reported collaboration and other revenue of $11 million, which was generated from the company's September 2024 licensing agreement with Context Therapeutics for the development and commercialization of BA3361, a Nectin-4 x CD3 T cell engaging CAB bispecific antibody. Total operating expenses for the period were $68.7 million, primarily driven by $51.45 million in research and development expenses related to the advancement of the company's clinical-stage programs. BioAtla reported a net loss of $54.9 million for the first nine months of 2024.
In the most recent quarter (Q3 2024), BioAtla reported revenue of $11 million and a net loss of $10.6 million. The $11 million in revenue was from a license agreement with Context Therapeutics for the Nectin-4 x CD3 T cell engaging bispecific antibody BA3362.
Liquidity
Despite the net losses, BioAtla has maintained a healthy financial position, with a current ratio of 3.11 and a quick ratio of 3.11 as of September 30, 2024, indicating a strong liquidity profile. The company's cash burn rate, as measured by net cash used in operating activities, was $55.2 million for the nine months ended September 30, 2024, a significant improvement from the $74.1 million reported in the same period of the previous year.
As of September 30, 2024, BioAtla had cash and cash equivalents of $56.5 million, which the company expects will be sufficient to fund its ongoing operations into early 2026 as it continues to focus on the clinical development of its prioritized CAB programs. The debt-to-equity ratio stands at 0.05, reflecting a conservative capital structure.
Operational Highlights and Pipeline
BioAtla's pipeline is anchored by several promising CAB-based drug candidates, each targeting key cancer pathways and demonstrating encouraging results in clinical trials.
Ozuriftamab vedotin (CAB-ROR2-ADC)
This CAB-based antibody-drug conjugate (ADC) targeting the ROR2 receptor is being evaluated in a Phase 2 clinical trial for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). In the third quarter of 2024, BioAtla reported that the therapy demonstrated durable clinical responses, with a median overall survival of approximately 9 months (ongoing) in a heavily pretreated patient population.
Out of 29 evaluable patients, 11 responses were observed, including 6 confirmed responses and 1 ongoing complete response. The median duration of response for confirmed responders is 4.4 months. These results are particularly meaningful given the heavily pretreated patient population (median of 3 prior lines of therapy), compared to overall response rates of 6-13% and median overall survival of 5.1-6.9 months for current standard of care in less heavily pretreated patients.
The company has received actionable feedback from the FDA regarding a proposed pivotal trial in second-line (2L) plus SCCHN, providing a clear path forward for this program. The FDA is supportive of a proposed prospective randomized pivotal trial design evaluating ozuriftamab vedotin versus investigator's choice (cetuximab, docetaxel or methotrexate) in recurrent/metastatic head and neck cancer patients. The trial is designed to potentially support accelerated approval followed by confirmation of clinical benefit. A limited randomized evaluation of the Q2W and 2Q 3W dosing schedules for ozuriftamab vedotin is underway.
Evalstotug (CAB-CTLA-4)
BioAtla's CAB-CTLA-4 antibody candidate has shown promising results in a Phase 2 clinical trial in combination with a PD-1 inhibitor for the treatment of first-line unresectable or metastatic melanoma. In the third quarter of 2024, the company reported that all eight patients treated achieved tumor reduction, with four responders, including three partial responses and one complete response. Importantly, the therapy demonstrated a relatively low incidence and severity of immune-related adverse events, a key differentiating factor.
Five patients received a 350mg dose (5mg/kg ipi equivalent) and three received ≥700mg (≥10mg/kg ipi equivalent). The safety profile suggests a relatively low incidence and severity of immune-related adverse events. Intra-patient dose escalation has led to reattainment of disease control in some patients. The FDA has provided guidance on ongoing dose optimization and control arm to enable a Phase 3 registrational trial in first-line metastatic/unresectable melanoma, anticipated to start next year.
Mecbotamab vedotin (CAB-AXL-ADC)
This CAB-AXL-ADC has demonstrated antitumor activity and improved overall survival in a Phase 2 trial for the treatment of non-small cell lung cancer (NSCLC) expressing mutated KRAS (mKRAS) variants, compared to patients with KRAS wild-type tumors. BioAtla continues to observe responses across multiple KRAS mutation variants, supporting the potential for a pan-KRAS strategy in this indication.
The company reported continued observation of antitumor activity with multiple confirmed responses among 21 evaluable patients with KRAS-mutant tumors. The median overall survival was 12.6 months in KRAS-mutant patients versus 8.7 months in KRAS wild-type patients. BioAtla is determining the most efficient path forward for a future pivotal trial.
In addition to these lead programs, BioAtla's pipeline includes the CAB-EpCAM x CAB-CD3 T cell engager, BA3182, which is currently in a Phase 1 dose-escalation study. The company has also recently announced a worldwide license agreement for the preclinical CAB-Nectin-4 x CAB-CD3 bispecific T cell engager with Context Therapeutics, demonstrating the value of its proprietary platform. This agreement resulted in a $15 million upfront and near-term milestone payment received by BioAtla.
Risks and Challenges
As a clinical-stage biotechnology company, BioAtla faces several risks and challenges inherent to the industry. The success of its pipeline is contingent upon the successful completion of clinical trials, regulatory approvals, and eventual commercialization of its product candidates. Any setbacks or delays in the development process could have a significant impact on the company's financial performance and future prospects.
Additionally, BioAtla operates in a highly competitive landscape, with other biotechnology and pharmaceutical companies pursuing similar targeted cancer therapies. The company's ability to maintain its competitive edge and secure market share will be crucial to its long-term success.
Lastly, as a company primarily focused on research and development, BioAtla's financial performance is heavily dependent on its ability to secure additional funding, either through collaborations, partnerships, or future equity or debt offerings. Any challenges in raising capital could hamper the company's growth and limit its ability to advance its pipeline.
Conclusion
BioAtla's innovative approach to cancer treatment through its CAB technology has positioned the company as a promising player in the biotechnology industry. With a diverse pipeline of drug candidates targeting key cancer pathways, the company has the potential to make a significant impact on the lives of cancer patients, provided it can successfully navigate the challenges of clinical development and regulatory approval.
As BioAtla continues to advance its pipeline and execute on its strategic initiatives, investors will closely monitor the company's progress and its ability to translate its scientific advancements into tangible commercial success. The company's strong financial position and disciplined cash management provide a solid foundation for its continued growth and development, making it a compelling investment opportunity for those seeking exposure to the rapidly evolving field of targeted cancer therapies.