Alpha Tau Medical (NASDAQ:DRTS) provided investors with a series of clinical, regulatory and financial updates, highlighting what company leadership described as “real and meaningful activity” over the past few months and setting expectations for multiple data readouts later in 2026. The discussion centered on progress across pancreatic cancer, glioblastoma (GBM), and the company’s pivotal U.S. skin cancer program, alongside a new approval in Japan and an evolving partnering landscape.
Technology overview and positioning
Management reiterated that Alpha Tau’s lead product, Alpha DaRT, is designed as a local intratumoral injection intended to deliver alpha particle radiation directly into tumors. The company described alpha radiation as more potent than conventional radiotherapy and said its approach enables dosing in microcuries rather than millicuries. According to the presentation, this lower dose level supports simpler logistics, including shipping via standard carriers and treatment in a regular clinical room without specialized radiation shielding infrastructure.
Pancreatic cancer: ASCO GI presentation and ongoing U.S. study
Alpha Tau highlighted a pancreatic cancer study led by clinicians in Montreal, with data presented at the ASCO Gastrointestinal Cancers Symposium in January. Management said the study received two presentations: one covering final patient data following completion of recruitment, and a second focused on immune effects.
In describing the final dataset, management said results were consistent with prior interim disclosures, including “fantastic safety” and disease control with response activity. The second presentation addressed immune findings; management said investigators compared patients’ immune systems before and after Alpha DaRT treatment to the pancreas and observed “no meaningful difference,” contrasting that with the immunosuppressive effects commonly associated with broader-field radiation therapies.
Separately, the company discussed its ongoing U.S. pancreatic cancer pilot study (described as “phase two-like”), launched in the second half of the prior year. Management said recruitment has progressed “very, very nicely,” citing limited alternatives for newly diagnosed pancreatic cancer patients. The company expects to finish treating patients in the next quarter and said it anticipates data in the second half of 2026.
Regulatory developments: modular PMA in the U.S. and approval in Japan
Alpha Tau said it has begun a “rolling submission” to the U.S. Food and Drug Administration using a Modular PMA pathway for its recurrent cutaneous squamous cell carcinoma (cSCC) pivotal program. Management said the company has already submitted preclinical/nonclinical components and plans to submit additional modules related to quality and manufacturing, with the clinical module expected after trial completion. The company framed the approach as a way to reduce review time by enabling the FDA to evaluate portions of the application before final clinical data are delivered.
In Japan, management reported that Alpha DaRT received approval for locally advanced unresectable head and neck cancer and locally recurrent head and neck cancer, calling it the company’s first approval outside Israel. Management noted the Japanese label was broader than expected based on the country’s pivotal study, which had focused on difficult recurrent patients. The company also credited support from six medical societies in Japan advocating for access to the technology.
The company said its immediate focus in Japan is meeting post-marketing surveillance (PMS) requirements set by the PMDA. Alpha Tau expects to treat 66 patients across five sites, working with partner HekaBio. Management also said the company plans to engage regulators on additional Japanese studies, with pancreatic cancer identified as a key area of interest given incidence levels described as high relative to population. In addition, Alpha Tau said it can now begin discussions with Japan’s Ministry of Health, Labor, and Welfare regarding reimbursement, including the possibility of reimbursement during the PMS period.
2026 milestones: skin cancer, GBM, and prostate study startup
Management characterized 2026 as a “transformative year,” pointing to three U.S. programs expected to reach key milestones:
- Recurrent cSCC pivotal study: The company said the trial is an 86-patient study with “single digits left” to treat, with last patient treatment expected in the next few weeks (around the end of the quarter or early April). Management expects data in the second half of 2026, noting the endpoints include response rate and six-month durability, implying final durability data may require 7–8 months after the last patient is treated.
- GBM pilot study: Alpha Tau said it began treating GBM patients in December and highlighted that the first patient went home the next day, with “95% coverage” of the tumor. The study is using a cautious dose-escalation approach, with three patients treated at a cadence of one per month followed by a safety review. Management said it expects to report this initial safety assessment next quarter and, if supportive, aims to complete recruitment in the second half of 2026.
- Pancreatic pilot study: The company reiterated expectations to complete treatment in the next quarter and report data in the second half of the year.
Alpha Tau also noted it had previously received FDA approval to conduct a study in locally recurrent prostate cancer and expects to begin treating patients in coming months as sites come online.
Commercial and partnering commentary; financial position
In discussing commercial potential for U.S. cSCC, management cited 1.8 million new cases annually in the U.S. and said the company is targeting more difficult cases rather than competing with routine surgical excision. Using literature estimates that roughly 3.5% of cases recur locally or spread to nodes, management sized its target opportunity at approximately 64,000 cases per year.
In Japan, management estimated the approved head and neck indications represent “a few hundred to low thousands” of patients annually. The company said it does not intend to conduct a large commercial launch in Japan near term and expects distribution to be handled by partners, currently HekaBio for PMS.
On partnerships, management said inbound interest has increased and described several categories under evaluation: geographic partnerships (including Japan), tumor-type commercialization arrangements (approached cautiously to avoid conflicting calls on the same physicians), combination work with checkpoint inhibitors based on early interim data previously disclosed, and collaborations with device and supply companies supporting delivery tools such as endoscopes, bronchoscopes, and biopsy needles.
Regarding operations, management said current military actions in the Middle East have not caused material disruptions, noting the company continues manufacturing and shipping treatments.
Finally, Alpha Tau reviewed its year-end financial position, reporting $77 million in cash and deposits at year-end and an operating burn rate of approximately $5 million to $6 million per quarter, excluding one-off capital expenditures tied to the first phase of facility construction in New Hampshire.
About Alpha Tau Medical (NASDAQ:DRTS)
Alpha Tau Medical Ltd. is a medical technology company headquartered in Ness Ziona, Israel, focused on developing targeted alpha-radiation therapies for the treatment of solid tumors. The company’s core innovation, known as Diffusing Alpha-emitters Radiation Therapy (DaRT), employs short-lived radioactive isotopes to deliver high-energy alpha particles directly within or adjacent to tumor tissues. By harnessing the potent cytotoxic effects of alpha radiation, Alpha Tau Medical aims to offer a novel approach to brachytherapy that can potentially overcome radioresistance and spare surrounding healthy tissue.
The company’s lead product, Alpha DaRT, is currently being evaluated in clinical studies for a range of indications including recurrent or metastatic head and neck cancers, skin cancers, and other solid tumors.
