Alpha Tau Medical (DRTS) R&D Day 2025 summary

Pipeline overview and program updates

• Alpha DaRT technology is being developed for localized, high unmet need, and metastatic solid tumors, including SCC, H&N SCC, prostate, GBM, pancreatic, liver, breast, and rectal cancers, with no observed resistance across tumor types.

• Clinical trials are ongoing or planned in the US, Canada, Israel, France, Europe, and Japan, spanning multiple indications and clinical phases.

• FDA Breakthrough Device Designation has been received for skin cancer and GBM applications.

• First-in-human studies for liver metastases and combination with checkpoint inhibitors are underway.

• Augmented reality navigation for DaRT delivery is in development with academic partners.

Clinical trial data and development milestones

• Pancreatic cancer trials (n=41) show 97% disease control rate (excluding underdosed patients), 100% feasibility in source delivery, and strong safety profile, with median overall survival up to 23 months in certain subgroups.

• Early data in liver metastases show technical feasibility, tumor shrinkage in both treated and untreated lesions, no device-related adverse events, and evidence of immune activation.

• Combination trial with pembrolizumab in H&N SCC shows all evaluable patients responded (3 complete, 3 partial in first 8 patients), with 75% objective response rate and 37.5% complete responses, and only mild device-related AEs.

• Reirradiation case studies in lung and rectal cancer demonstrate high efficacy, tumor shrinkage, and minimal toxicity, even in previously irradiated tissues.

• Pivotal US trial for recurrent cutaneous SCC targets completion in Q3 2025 and FDA submission in H1 2026.

R&D strategy and innovation priorities

• Emphasis on expanding Alpha DaRT to high unmet need and metastatic indications, leveraging immune effects and combination with immunotherapies.

• Ongoing development of novel delivery devices, digital navigation, and real-time tumor visualization tools, with collaborative grants and partnerships.

• Focus on minimally invasive, outpatient procedures to lower barriers to adoption.

• Plans to initiate new studies in the US for pancreatic cancer, GBM, and head and neck cancer in combination with immunotherapy.