Alpha Tau Medical (DRTS) investor relations material

Key clinical trial updates

• Three major studies—ReSTART (skin cancer), IMPACT (pancreatic cancer), and REGAIN (brain cancer)—are progressing, with significant data readouts expected by year-end or early 2027.

• U.S. pivotal trial for recurrent cutaneous SCC completed patient treatment; data expected by year-end for FDA submission.

• FDA breakthrough designation and rolling application in place for SCC, expediting regulatory review.

• Pancreatic cancer trial expanded to 40 patients, with recruitment to finish next quarter and data expected by year-end.

• Glioblastoma study at Ohio State showed 2 of 3 patients with complete response; awaiting FDA clearance to treat more patients.

Product innovation and mechanism

• Local alpha radiation delivery via direct tumor injection using radium-224 enables targeted, efficient tumor cell killing.

• Mild to moderate, localized side effects observed; systemic side effects are minimal.

• Approved for use in Israel and recently in Japan for head and neck cancers, with post-marketing surveillance underway.

Immunotherapy and combination studies

• Combination with pembrolizumab (KEYTRUDA) in head and neck cancer showed higher systemic response rates than KEYTRUDA alone.

• Final results from this combination study to be presented at the American Head and Neck Society in summer 2026.

• Evidence of immune response activation, including T cell proliferation and abscopal effects, observed in both animal and human studies.