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

Technology overview and clinical rationale

• Alpha DaRT technology uses alpha radiation for local treatment of solid tumors, offering higher potency and efficiency than conventional gamma or beta radiation.

• The method involves injecting radium-224 coated sources into tumors, releasing alpha-emitting daughter isotopes that diffuse deeper, achieving a clinically useful range of about 5mm.

• Demonstrated potential applicability to nearly any solid tumor, with preclinical studies showing universal tumor response.

• Three core focus areas: localized unresectable tumors, high unmet need cancers (e.g., glioblastoma, pancreatic), and leveraging systemic immune response.

• Treatment may catalyze immune recognition, suggesting synergy with immunotherapies and potential for systemic effects.

Clinical data and trial progress

• U.S. skin cancer trial showed 100% complete response rate with mild, local side effects and no serious systemic toxicity.

• Pivotal U.S. study for recurrent squamous cell carcinoma of the skin is ongoing, with recruitment expected to finish by end of 2024 or early 2025.

• Pancreatic cancer trial in Canada demonstrated excellent safety and feasibility, with hints of efficacy even at suboptimal doses and a 60% disease control rate.

• Preclinical and early clinical data indicate immune-mediated effects, including regression of untreated tumors and synergy with checkpoint inhibitors.

• Additional trials underway in liver metastases, vulvar, prostate, breast, and lung cancers, with regulatory submissions in Israel and Japan.

Commercial outlook and financials

• Near 100% response rates in hard-to-treat cancers position the therapy as a compelling alternative to surgery, chemotherapy, and expensive immunotherapies.

• Target market includes high-risk and recurrent skin cancer cases, estimated at 150,000 new U.S. cases annually.

• Pricing expected to be competitive with advanced radiation therapies ($50,000–$70,000 per regimen), with ongoing assessment as data from other indications mature.

• Commercial preparations include reimbursement planning and sales force development, with U.S. launch targeted post-approval.

• Financially, the company maintains a lean burn rate (~$5M/quarter), with $74M cash on hand and at least two years of runway.