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BioAtla and GATC Health Announce a $40 Million Special Purpose Vehicle (SPV) Transaction to Advance Ozuriftamab Vedotin (Oz-V) into a Registrational Trial for 2L+ Oropharyngeal Squamous Cell Carcinoma (OPSCC)

1. BioAtla secures $5 million for Oz-V clinical trials in OPSCC. 2. Final $35 million funding expected by Q1 2026, enabling Phase 3 trial. 3. BioAtla retains 65% ownership of Oz-V post SPV transaction. 4. Oz-V targets ROR2, significant for tumor progression and aging diseases. 5. Partnership may expand Oz-V applications to broader markets, over $7 billion.

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FAQ

Why Bullish?

The funding and continued development of Oz-V significantly improve BCAB’s growth prospects. Historical stock movements following similar clinical trial announcements show positive trends for biotech stocks.

How important is it?

The funding and clinical progress of Oz-V are crucial for BioAtla's growth and potential revenue generation, reflecting significant investor interest.

Why Long Term?

With Phase 3 initiation expected and potential market expansion, positive outcomes may drive sustained growth. Long-term data post-trial completion will clarify Oz-V’s market positioning.

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BioAtla and GATC Health Launch $40 Million SPV Transaction for Ozuriftamab Vedotin Development

On December 31, 2025, BioAtla, Inc. (Nasdaq: BCAB) announced a significant development in its pipeline aimed at treating oropharyngeal squamous cell carcinoma (OPSCC). The clinical-stage biotechnology firm has formed a special purpose vehicle (SPV) transaction with GATC Health Corp., securing an initial funding of $5 million and anticipating an additional $35 million to support the advancement of ozuriftamab vedotin (Oz-V) into a registrational Phase 3 trial targeting second-line (2L+) OPSCC.

Funding Details and Ownership Structure

The SPV transaction involves BioAtla receiving an upfront $5 million for operational and clinical trial expenses related to Oz-V, with the remainder of the financing expected to finalize in the first quarter of 2026. Following the completion of the SPV transaction, BioAtla will retain a 65% ownership stake in Oz-V across all solid tumor indications, while Inversagen AI, LLC will acquire a 35% ownership.

This innovative financing structure aims to enhance BioAtla’s equity value while enabling the exploration of broader applications for Oz-V, particularly in HPV-positive cancers, including cervical cancer, which offers a market opportunity exceeding $7 billion globally.

Phase 3 Trial and Treatment Implications

The upcoming Phase 3 trial for Oz-V is set to begin enrollment in early 2026. BioAtla will lead the trial's execution, aiming for potential accelerated approval. Dr. Jay M. Short, CEO of BioAtla, stated, “We are excited to announce this partnership for advancing Oz-V into Phase 3 development for the treatment of patients with OPSCC under this creative, single-asset financing structure...”

Oz-V targets the ROR2 receptor, a critical player in tumor progression and cellular senescence, thus linking it to aging-related diseases. According to Dr. Ian Jenkins, Chief Scientific Officer at GATC Health, “ROR2 is an attractive therapeutic target as it functions at the crossroads of cancer, senescence, and inflammation.” This dual action could pave the way for new therapies that are less harmful to beneficial senescent cells.

Strategic Collaborations and Future Prospects

BioAtla and GATC Health also plan to collaborate with Inversagen AI for the research and development of CAB senolytic therapies, maintaining BioAtla’s rights to the cancer therapeutic applications of these new innovations. “This is an important partnership for us as it provides a near-term commercial opportunity in OPSCC, as well as laying the foundation to advance our mission to cure age-related diseases,” said Jayson Uffens, CTO of GATC Health.

About Ozuriftamab Vedotin (Oz-V)

Oz-V (CAB-ROR2-ADC) is a conditionally and reversibly active antibody-drug conjugate targeting ROR2, a receptor involved in various solid tumors, including those in the head and neck. The FDA has granted Fast Track Designation for Oz-V, recognizing its potential in treating recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

The treatment is particularly relevant given the rising incidence of OPSCC, predominantly attributed to HPV infections, constituting around 80% of OPSCC cases in the U.S. The prognosis for those with recurrent or metastatic OPSCC who have exhausted standard treatments remains poor, underscoring the urgent need for new therapeutic options like Oz-V.

Conclusion

This partnership between BioAtla and GATC Health marks a pivotal moment in the battle against OPSCC and potentially other HPV-related cancers. With the innovative finance structure and strategic focus on ROR2, BCAB is positioned to lead advancements in oncology, particularly through the commercialization of Oz-V.

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