Alpha Tau Medical (DRTS) Sidoti Small-Cap Virtual Conference summary

Clinical and scientific updates

• Developed a method to deliver alpha particles directly into tumors, offering a potent, localized radiation therapy with minimal systemic side effects.

• Demonstrated efficacy across 20+ tumor types in animals and several in humans, with no tumor type unresponsive so far.

• Achieved regulatory milestones: approved in Israel for SCC of skin and oral cavity, PMDA approval pending in Japan, and pivotal US trial underway for recurrent skin cancer.

• US pivotal trial for skin cancer is under FDA breakthrough designation, aiming for approval as early as late next year.

• Focused on high-risk, later-line patients, targeting about 64,000 US cases annually for skin cancer.

Expansion into metastatic and high unmet need cancers

• Observed immune responses in metastatic patients, with some untreated tumors regressing after local therapy.

• Combination study with Keytruda in head and neck cancer showed a 37.5% complete response rate and 75% objective response, far exceeding historical Keytruda results.

• Case studies highlight systemic effects, including a 96-year-old woman with complete regression of untreated tumors.

• Running trials in pancreas, liver, lung, prostate, and soon brain, focusing on cancers with limited treatment options.

Pancreatic cancer trial results and plans

• Initial data from 41 pancreatic cancer patients showed nearly 20% response and almost 100% disease control.

• Median survival for non-chemo patients doubled to 7.5 months; post-FOLFIRINOX patients exceeded 15 months survival.

• Post-second-line chemo patients had 23 months survival, much higher than expected.

• FDA approved a new US trial for newly diagnosed locally advanced or metastatic pancreatic cancer, combining FOLFIRINOX and Alpha DaRT.