Alpha Tau Medical (DRTS) 44th Annual J.P. Morgan Healthcare Conference summary

Key technology and clinical approach

• Developed a local intratumoral cancer treatment using alpha particles, overcoming previous limitations in range and delivery by leveraging radium-224 decay chains for deeper tumor penetration.

• Treatment delivers potent, conformal radiation with minimal systemic exposure, using microcurie doses and standard clinical workflows.

• Demonstrated broad applicability across tumor types, with no observed resistance in preclinical studies.

• Focused on three core areas: late-line localized tumors, metastatic settings with immune activation, and high unmet need cancers like GBM and pancreatic cancer.

• Technology allows for repeat treatments and is agnostic to tumor antigens or mutations.

Clinical milestones and data highlights

• Five U.S. clinical trials ongoing, with pivotal studies in skin cancer, pilot studies in pancreatic cancer, and feasibility in glioblastoma, all targeting recruitment completion in the first half of the year and data in the second half.

• Achieved 100% complete response rate in a U.S. pilot study for recurrent cutaneous SCC, with no serious adverse events.

• Interim data in metastatic head and neck cancer showed systemic responses and high complete response rates when combined with pembrolizumab, far exceeding historical controls.

• Pancreatic cancer interim data showed median overall survival significantly above literature benchmarks in multiple patient subgroups.

• First patient treated in GBM trial showed over 95% tumor coverage and no side effects, with rapid post-procedure recovery.

Regulatory and commercial progress

• Approved for marketing in Israel for squamous cell carcinoma; awaiting imminent approval decision in Japan for head and neck cancer.

• U.S. pivotal skin cancer study using a modular PMA process, with technical file already submitted and ongoing FDA discussions.

• Breakthrough designation in several indications, facilitating faster regulatory and reimbursement pathways.

• Engaged in FDA's TAP program for GBM, providing access to regulatory and commercial advisory resources.

• Manufacturing expansion underway, with a new commercial facility in New Hampshire targeting 15,000 patient capacity per year.