Kura Oncology reported Q2 2025 financial results, with a focus on its lead asset, tipifarnib. The company plans to submit a new drug application to the FDA in Q4 2025 for the treatment of HRAS-mutated head and neck squamous cell carcinoma. Kura Oncology also discussed its ongoing Phase 1 trial for the treatment of adult patients with relapsed/refractory T-Cell lymphoma.
Kura Oncology (NASDAQ: KURA) reported its second-quarter 2025 financial results, highlighting progress in its oncology pipeline and a focus on its lead asset, tipifarnib. The company aims to submit a new drug application (NDA) to the FDA in Q4 2025 for the treatment of HRAS-mutated head and neck squamous cell carcinoma. Additionally, Kura Oncology discussed its ongoing Phase 1 trial for the treatment of adult patients with relapsed/refractory T-Cell lymphoma.
Financial Highlights
Kura Oncology reported a net loss of $66.1 million for Q2 2025, with research and development (R&D) expenses of $62.8 million and general and administrative (G&A) expenses of $25.2 million. The company ended the quarter with $630.7 million in cash, cash equivalents, and short-term investments, extending its cash runway into 2027 [1].
Tipifarnib and HRAS-mutated Head and Neck Squamous Cell Carcinoma
Kura Oncology is planning to submit an NDA for tipifarnib in Q4 2025 to the FDA for the treatment of HRAS-mutated head and neck squamous cell carcinoma. The company's focus on this indication is part of its broader strategy to leverage the potential of menin inhibition in various cancer types [1].
T-Cell Lymphoma Trial
The company is also conducting a Phase 1 trial (KURRENT-HN) for the treatment of adult patients with relapsed/refractory T-Cell lymphoma. This trial is evaluating tipifarnib in combination with alpelisib, a PIK3CA inhibitor, for patients with PIK3CA-dependent head and neck squamous cell carcinoma [1].
Pipeline and Future Prospects
Kura Oncology's pipeline includes several promising candidates, with three clinical abstracts accepted for presentation at the 2025 ESMO Congress. The company is also planning to initiate two Phase 3 trials in frontline AML settings in the second half of 2025 [1].
References
[1] https://www.stocktitan.net/news/KURA/kura-oncology-reports-second-quarter-2025-financial-mmr9u8q8zsnk.html
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