BioAtla, Inc. (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 platform technology enables the creation of highly specific and selective antibody-based treatments, offering the potential to revolutionize cancer care.
Company History and Evolution BioAtla was formed in Delaware in March 2007 and was converted to a Delaware corporation in July 2020. The company has developed a proprietary platform for creating biologics, including its conditionally active biologics (CABs) technology. CABs have been designed to be active only under certain conditions found in diseased tissue, while remaining inactive in normal tissue.
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 includes the ongoing Phase 2 clinical trials of mecbotamab vedotin (BA3011), ozuriftamab vedotin (BA3021), and evalstotug (BA3071), as well as the ongoing Phase 1 clinical trial of BA3182 CAB-EpCAM x CAB-CD3. The company has also worked on establishing and maintaining its intellectual property portfolio, manufacturing clinical and research material through third parties, hiring personnel, and establishing product development and commercialization collaborations with third parties.
BioAtla has incurred significant losses to date, with a net loss of $123.5 million for the year ended December 31, 2023 and an accumulated deficit of $471.2 million as of September 30, 2024. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with the company's operations. BioAtla has not yet demonstrated the ability to successfully obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on its behalf, or conduct sales and marketing activities necessary for successful product commercialization.
Financial Performance and Liquidity As a clinical-stage biotechnology company, BioAtla's financial performance has been characterized by substantial research and development investments to advance its pipeline. For the fiscal year 2023, the company reported a net loss of $123.5 million, with no revenue generated. This reflects the company's focus on driving its product candidates through the rigorous clinical trial process. The company's operating cash flow (OCF) for 2023 was negative $104.02 million, and its free cash flow (FCF) was negative $104.11 million.
In the third quarter of 2024, BioAtla reported $11 million in collaboration and other revenue, primarily related to a licensing agreement for its BA3362 product candidate. This represents a significant improvement from the prior year period when the company did not generate any revenue. The net loss for Q3 2024 was $10.59 million, with an OCF and FCF of negative $5.13 million each. Research and development expenses for the quarter were $16.39 million, while general and administrative expenses totaled $5.88 million.
Despite the ongoing financial challenges, BioAtla has maintained a relatively strong balance sheet. As of September 30, 2024, the company had $56.5 million in cash and cash equivalents, down from $111.5 million at the end of 2023. This cash position is expected to fund the company's planned operations into early 2026, providing a runway to complete dose optimization for its lead programs and position them for potential registrational trials.
BioAtla's liquidity position has been supported by its ability to secure non-dilutive funding through collaborations and licensing agreements. In September 2024, the company announced a $133.5 million worldwide licensing agreement with Context Therapeutics for a preclinical CAB-based bispecific T-cell engager, showcasing the value of its proprietary technology platform.
The company's financial health is further reflected in its liquidity ratios. As of September 30, 2024, BioAtla had a debt-to-equity ratio of 0.0546, indicating a low level of debt relative to equity. Both the current ratio and quick ratio stood at 3.11, suggesting a strong ability to meet short-term obligations.
BioAtla operates primarily in the United States, and no specific information was provided about performance in other geographic markets. The company has not reported any scandals, short seller reports, or CEO departures that could impact its financial standing or market perception.
Clinical Pipeline and Regulatory Milestones BioAtla's pipeline is anchored by its lead programs, which have demonstrated promising results in advanced clinical trials. The CAB-ROR2-ADC ozuriftamab vedotin, being evaluated for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), has shown meaningful antitumor activity and a manageable tolerability profile in heavily pretreated patients. The company has provided updated data showing that the median duration of response for all confirmed responders is 4.4 months, and the median overall survival for these patients is now approximately 9 months, which is a significant improvement compared to the current standard of care.
The company recently received actionable feedback from the U.S. Food and Drug Administration (FDA) regarding the proposed pivotal trial design for ozuriftamab vedotin in second-line (2L) plus SCCHN. The FDA has expressed support for a randomized trial comparing ozuriftamab vedotin to investigator's choice of cetuximab, docetaxel, or methotrexate, with the potential to support an accelerated marketing authorization followed by confirmation of clinical benefit.
In the case of the CAB-CTLA-4 antibody evalstotug, BioAtla has reported encouraging results from its Phase 2 study in first-line unresectable or metastatic melanoma. All 8 patients treated with evalstotug in combination with a PD-1 inhibitor achieved tumor reduction, with 4 patients experiencing responses, including 1 complete response. Five patients received a 350-mg dosing level (equivalent to 5 mg/kg ipilimumab) and 3 received at least 700 mg (equivalent to 10 mg/kg ipilimumab). Importantly, the safety profile has demonstrated a relatively low incidence and severity of immune-related adverse events, a common challenge with CTLA-4 inhibitors.
The company has received FDA guidance on the ongoing dose optimization and control arm for the planned Phase 3 registrational trial of evalstotug in first-line metastatic or unresectable melanoma, which is anticipated to commence next year.
For the CAB-AXL-ADC mecbotamab vedotin, BioAtla continues to observe antitumor activity with multiple confirmed responses among 21 evaluable patients with tumors expressing mutant KRAS, across 9 different KRAS variants. The median overall survival is 12.6 months for mutant KRAS patients compared to 8.7 months for KRAS wild-type, indicating potential efficacy in this hard-to-treat patient population.
Risks and Challenges As a clinical-stage biotechnology company, BioAtla faces a range of risks and challenges inherent to the industry. The successful development and commercialization of its product candidates are subject to regulatory approvals, clinical trial outcomes, and competition from other innovative therapies. The company's reliance on third-party manufacturers and service providers also introduces operational and supply chain risks that must be carefully managed.
Additionally, BioAtla's financial position requires ongoing access to capital markets and strategic collaborations to fund its research and development efforts. Fluctuations in the company's cash position and the need for additional financing could impact its ability to execute its strategic plans.
Despite these challenges, BioAtla's innovative CAB platform, promising clinical results, and strong intellectual property portfolio position the company as a compelling player in the oncology drug development landscape. The company's continued focus on advancing its lead programs and building strategic partnerships will be critical in navigating the path forward.
Future Outlook BioAtla is maintaining its guidance for a potential near-term collaboration for at least one of its Phase II assets, which could provide additional non-dilutive funding and validation of its technology platform. The company's current cash position is expected to fund planned operations into early 2026, which management believes is sufficient to complete dose optimization for CAB-ROR2 and CAB-CTLA4, and position these programs for registrational trials in head and neck cancer and melanoma, respectively.
Conclusion BioAtla's pioneering work in Conditionally Active Biologics has the potential to transform cancer treatment. The company's clinical pipeline, led by the CAB-ROR2-ADC ozuriftamab vedotin and the CAB-CTLA-4 antibody evalstotug, has demonstrated encouraging results that underscore the promise of its innovative approach. As BioAtla navigates the regulatory landscape and continues to optimize its product candidates, the company's ability to secure strategic collaborations and maintain a strong financial position will be crucial to its long-term success. Investors and the broader oncology community will be closely watching BioAtla's progress as it strives to bring its transformative therapies to patients in need.