DRTS Filings — Alpha Tau Medical Ltd.

DRTS Filings — Alpha Tau Medical Ltd. - FilingSpy

20-F · Fiscal year ended Dec 31, 2025 · SEC filing ↗

Alpha Tau's net loss widened to $42.6M as the pivotal ReSTART trial timeline slipped again, pushing top-line data into 2026.

The pivotal trial timeline slipped further, and the cash runway is now measured in months. Net loss widened to $42.6 million in 2025 from $31.8 million, driven by a 34% increase in R&D spending, while cash and equivalents fell to $12.2 million. The company must raise capital to reach its next data readout.

Key takeaways

The timeline for top-line results from the U.S. pivotal ReSTART trial for recurrent cutaneous squamous cell carcinoma has been delayed, with data now expected in 2026 rather than early 2026.
Net loss widened to $42.6 million from $31.8 million in 2024, as operating expenses rose and financial income declined.
Research and development expenses rose 34% to $36.2 million, driven by increased clinical trial activity, employee compensation, and raw material costs for the ReSTART trial.
Cash and equivalents fell to $12.2 million at year-end from $13.7 million, and free cash outflow was $32.8 million, up from $22.0 million in 2024.
The company received marketing approval in Japan for Alpha DaRT in unresectable head and neck cancer, its second regulatory authorization after Israel.
Interim data in pancreatic cancer showed an 18% and 91% , while a combination study with pembrolizumab in head and neck cancer showed a 75% systemic objective response rate.

What changed

The ReSTART trial timeline, previously flagged as a key watch item with top-line results expected in early 2026, has been pushed to an unspecified date in 2026.
The outcome of the Japanese pre-market approval application, flagged as pending in the 2024 filing, was resolved: Alpha Tau received marketing approval for recurrent head and neck cancer.
The cash runway, which management had stated would fund operations into 2026, is now under pressure as cash and equivalents fell to $12.2 million against a $32.8 million annual free cash outflow.

What to watch

The specific date in 2026 when top-line results from the ReSTART trial will be reported.
Any financing transaction or capital raise, given the $12.2 million cash balance and $32.8 million annual free cash outflow.
Progress on the FDA premarket approval application and whether the agency requires a PMA or de novo pathway.
Advancement of the pancreatic cancer and pembrolizumab combination programs toward registrational trials, following the interim data reported.

Section summaries

Quantitative and Qualitative Disclosures About Market Risk

Primary market risks are foreign currency exposure from Israeli operations and minimal interest rate risk from a small land-lease loan.

The company's main market risk is foreign currency exposure, primarily from operations in Israel where costs are in NIS but results are reported in USD.
During 2025, the USD strengthened against the NIS by approximately 12.5%, negatively impacting the USD cost of Israeli operations.
A hypothetical 10% unfavorable move in foreign exchange rates would have increased operating expenses by 5.6% in 2025 and 4.7% in 2024.
Interest rate risk is deemed immaterial as the company's only is a $6,352 loan from Bank Leumi for a Jerusalem land lease.

DRTS