Alpha Tau Medical (DRTS) investor relations material

Key clinical and technological updates

• Achieved first patient treatment in recurrent glioblastoma at Ohio State University, marking a milestone in brain cancer therapy.

• Pivotal study in recurrent skin cancer in the U.S. aims to finish patient recruitment in Q1 2026, with data expected later that year for FDA submission.

• FDA approved a new pilot study for pancreatic cancer, with strong interim data showing over 90% disease control and promising survival trends.

• Fifth concurrent IDE trial approved in the U.S., now including locally recurrent prostate cancer.

• Early data from a combination study with Keytruda showed all evaluable patients responded, suggesting enhanced systemic anti-tumor immunity.

Scientific and clinical rationale

• Alpha particle-based therapy enables highly localized, potent tumor cell killing with minimal impact on healthy tissue.

• Unique delivery system extends the effective range of alpha particles within tumors, overcoming previous limitations.

• Demonstrated strong safety profile in hundreds of patients, with only mild, localized side effects.

• Preclinical and clinical evidence suggests potential for broad applicability across solid tumor types.

• Observed abscopal effects and synergy with immunotherapy, indicating possible systemic benefits.

Regulatory and commercial progress

• Approval in Israel for skin and head and neck cancers; Japan submission pending with a decision expected within weeks.

• U.S. pivotal study in skin cancer is the main focus for first commercial launch, targeting high-value, difficult-to-treat cases.

• Commercial-scale manufacturing facility in New Hampshire completed first phase and received radioactive license.

• Company maintains a strong cash position with $76 million at Q3 and a quarterly burn rate of about $5 million.

• First major commercial launch anticipated in the U.S. around 2027, with potential for earlier or broader launches depending on trial outcomes.