- Tremendous activity in recent months, including receipt of Japanese marketing approval, the fifth parallel U.S. trial approval, data from pancreatic cancer trials presented at ASCO GI Symposium, and the first brain cancer treatment -
- Multiple meaningful milestones targeted in the coming months, including completion of patient recruitment in the U.S. pivotal ReSTART skin cancer trial, in the U.S. pilot IMPACT pancreatic cancer trial, and in the U.S. recurrent glioblastoma multiforme feasibility trial -
- $76.9 million in cash, cash equivalents & deposits provides continued balance sheet strength for clinical advancement and commercial preparation -
JERUSALEM, March 09, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT$(R)$ , reported full year 2025 financial results and provided a corporate update.
"The pace of progress at Alpha Tau today is unlike anything we've ever seen before," said Alpha Tau Chief Executive Officer Uzi Sofer. "With a slew of meaningful announcements in the past few months, culminating most recently with our receipt of marketing approval in Japan, our first outside of Israel, and with multiple meaningful milestones targeted for the coming months, we remain laser focused on execution. Clinical trial progress remains our highest priority, with an astounding five clinical trials approved in parallel in the U.S. At the same time, we continue to build out our manufacturing capabilities in New Hampshire as well as our pre-commercial preparations, while entertaining multiple tracks of strategic dialogue with partners who show increasing excitement about the ever-expanding prospects for Alpha DaRT."
Recent Corporate Highlights:
-- Commercial-Scale U.S. Manufacturing Milestone: In October, Alpha Tau
announced the receipt of a radioactive material license for its New
Hampshire manufacturing facility, its first commercial-scale facility.
The license paves the way for the introduction of radioactive material
and continued positive momentum toward initiating Alpha DaRT treatment
manufacturing onsite in 2026. Total expected nameplate capacity from the
first phase of construction is approximately 400,000 Alpha DaRT sources
for local use, subject to a number of operational and clinical
assumptions.
-- FDA Approval to Start Prostate Cancer Trial: In December, Alpha Tau
announced that the FDA has approved an Investigational Device Exemption
$(IDE)$ application to initiate a pilot study for the treatment of patients
with locally recurrent prostate cancer using the Company's Alpha DaRT
technology. According to the National Cancer Institute, over 300,000 new
cases of prostate cancer were expected to be diagnosed in 2025, and
clinical literature indicates that up to 15% of patients treated with
external beam radiation therapy can develop local recurrence within 15
years of treatment. The clinical trial is expected to enroll up to 12
U.S. patients with locally recurrent prostate cancer who have
demonstrated biochemical recurrence by the Phoenix definition (a rise of
PSA levels by 2 ng/mL from the PSA nadir). For more information, please
see here: https://clinicaltrials.gov/study/NCT07290998
-- First Patient Treated in U.S. Brain Cancer Trial: In December, Alpha Tau
treated its first patient in its pilot study for the treatment of
patients with recurrent glioblastoma multiforme (GBM) using the Alpha
DaRT technology. According to the National Brain Tumor Society,
glioblastoma is one of the most complex, deadly, and treatment-resistant
cancers, with an estimated average survival rate of only 8 months, and
this pilot study is a key part of Alpha Tau's broader strategy to bring
Alpha DaRT to cancer patients with some of the highest unmet needs. For
more information, please see here:
https://clinicaltrials.gov/study/NCT06910306
-- First Module Submitted to FDA as Part of Application for Marketing
Authorization in Skin Cancer: In January, the Company announced the
submission of the first module of its pre-market approval (PMA)
application to the U.S. Food and Drug Administration (FDA), following the
FDA's previous decision to allow the Company to use the more flexible
modular approach. The Company submitted the module with respect to
non-clinical studies as part of an application for the use of Alpha DaRT
in treating recurrent cutaneous squamous cell carcinoma (cSCC), the
second most common form of skin cancer, for patients not indicated for
surgery or standard radiation therapy, and for whom no curative systemic
treatment is available.
-- New Positive Data in Pancreatic Cancer Presented at ASCO: In January,
investigators from the Company's first-in-human pancreatic cancer study
in Montreal, Canada exploring the use of Alpha DaRT in treating
pancreatic ductal adenocarcinoma (PDAC) were awarded two separate
presentations at the 2026 ASCO Gastrointestinal Cancers Symposium
showcasing results from the trial. The results demonstrated a 22%
objective response rate $(ORR)$ and an 81% disease control rate (DCR)
across all 32 patients treated in the study, or 23% ORR and 87% DCR when
excluding the first two patients, who were deliberately given low dosages
in order to examine feasibility and safety only. In addition,
investigators presented results showing the immune-preserving profile of
Alpha DaRT in PDAC, based on immune markers as well as inflammatory
indices known to be negative prognostic indicators, and which typically
worsen after other forms of radiation therapy.
-- Received Marketing Approval in Japan for Head and Neck Cancer: In
February, Alpha Tau announced the receipt of Japanese marketing approval
for Alpha DaRT in unresectable locally advanced or locally recurrent head
and neck cancer, marking the first regulatory approval of the Alpha DaRT
platform outside Israel. As part of the approval, Alpha Tau will need to
conduct a post-market surveillance (PMS) study enrolling 66 patients in
total at five selected leading clinical centers in Japan, and the
Company's immediate focus is on working closely with Japanese clinicians
to complete the PMS study and to generate high-quality clinical data in
patients with unresectable locally advanced or locally recurrent disease.
Expected Upcoming Milestone Targets:
-- Completion of patient recruitment in the ReSTART pivotal U.S.
multi-center trial in recurrent cutaneous squamous cell carcinoma at the
end of Q1 2026. For more information, please see here:
https://www.clinicaltrials.gov/study/NCT05323253
-- Completion of patient recruitment in pancreatic cancer pilot study in the
U.S. in Q2 2026. For more information, please see here:
https://www.clinicaltrials.gov/study/NCT06698458
-- Initial safety readout from the first three patients in the recurrent GBM
trial in Q2 2026, and completion of patient recruitment in the second
half of 2026. For more information, please see here:
https://clinicaltrials.gov/study/NCT06910306
Financial results for year ended December 31, 2025
R&D expenses for the year ended December 31, 2025 were $32.1 million, compared to $27.0 million for the same period in 2024, due to increased employee compensation and benefits, increased costs of raw materials, and increased third-party contractor expenses (including clinical trial sites).
Marketing expenses for the year ended December 31, 2025 were $1.9 million, compared to $2.3 million for the same period in 2024, due to decreased compensation expenses and travel abroad.
G&A expenses for the year ended December 31, 2025 were $8.4 million, compared to $6.7 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation, and increased professional fees (including legal and IR expenses).
Financial expense, net, for the year ended December 31, 2025 was $0.2 million, compared to $4.3 million financial income, net, for the same period in 2024, due to a decrease in income from remeasurement of warrants and in interest from bank deposits as well as increased expense from changes in foreign exchange rates.
For the year ended December 31, 2025, the Company had a net loss of $42.6 million, or $0.53 per share, compared to a net loss of $31.8 million, or $0.45 per share, in the year ending December 31, 2024.
Balance Sheet Highlights
As of December 31, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $76.9 million, compared to $62.9 million at December 31, 2024.
Annual Report Availability
Alpha Tau's Annual Report on Form 20-F for the fiscal year ended December 31, 2025, has been filed today with the Securities and Exchange Commission. The Annual Report on Form 20-F can be accessed on the Investor Relations section of Alpha Tau's website at https://www.alphatau.com and on the SEC's website at www.sec.gov.
About Alpha DaRT(R)
Alpha DaRT(R) (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.
About Alpha Tau Medical Ltd.
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March 09, 2026 16:02 ET (20:02 GMT)