Instil Bio reports Q2 financials, '2510 IND cleared by US FDA.

• Instil Bio cleared US IND for AXN-2510/IMM2510 • US clinical trial initiation anticipated by end of 2025 • Updated '2510 monotherapy data in squamous-NSCLC to be presented at IASLC's 2025 WCLC • Instil Bio reports Q2 2025 financial results and corporate update • Appointed Jamie Freedman, M.D., Ph.D., as Chief Medical Officer • ImmuneOnco announces preliminary safety and efficacy data for '2510 in lung cancer

Instil Bio (Nasdaq: TIL) reported its second quarter 2025 financial results and corporate updates, highlighting significant milestones achieved by the company. The biopharmaceutical firm secured FDA clearance for its Investigational New Drug (IND) application for AXN-2510/IMM2510, enabling the initiation of a U.S. clinical trial before the end of 2025. This regulatory milestone marks a critical step in Instil Bio's clinical development strategy, particularly as it builds upon preliminary data from Chinese trials conducted by collaborator ImmuneOnco.

The company appointed Jamie Freedman, M.D., Ph.D., as Chief Medical Officer in June, bringing new leadership to the clinical development efforts at a pivotal time. Additionally, updated '2510 monotherapy data in squamous-NSCLC will be presented at the IASLC's 2025 World Conference on Lung Cancer in September, providing valuable insights into the clinical potential of Instil's lead asset.

On the financial front, Instil Bio maintains a cash position of $103.6 million, consisting of $7.7 million in cash and equivalents, $0.2 million in restricted cash, $84.1 million in marketable securities, and $11.7 million in long-term investments, as of June 30, 2025. This cash position is expected to fund operations beyond 2026. However, the company reported a non-GAAP net loss per share of $2.88 for Q2 2025, indicating a 41% deterioration compared to Q2 2024. The increased loss stems from higher R&D expenses and substantial restructuring charges, with in-process R&D expenses of $10.0 million and R&D expenses of $6.7 million recorded in Q2 2025.

While general and administrative expenses decreased to $6.2 million from $10.7 million year-over-year, the overall financial trajectory remains challenging. Investors should monitor the upcoming presentation of updated '2510 monotherapy data in squamous-NSCLC at the World Conference on Lung Cancer in September, which could provide valuable insights into the clinical potential of Instil's lead asset.

References:
[1] https://www.stocktitan.net/news/TIL/instil-bio-reports-second-quarter-2025-financial-results-and-dkknvahxsozq.html