On January 29, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT reported the following letter to shareholders:
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Following an incredibly productive 2025, culminating in several significant announcements in recent weeks, I wish to share with you an updated comprehensive picture of Alpha Tau’s position and projected upcoming milestones, as we continue to push forward with our clinical, operational and pre-commercial development on a number of different fronts.
Extensive Ongoing Clinical Activity
The Company is currently conducting multiple significant clinical trials around the world, with five concurrently approved trials in the U.S.:
● Our ReSTART (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy) multi-center pivotal trial in patients with recurrent cutaneous squamous cell carcinoma (cSCC) , the second most common form of skin cancer: View Source
● Our multicenter study in immunocompromised patients with cSCC: View Source
● Our IMPACT (Intratumoral Pancreatic Alpha Combination Trial) multi-center pilot study in patients with newly-diagnosed pancreatic cancer in combination with chemotherapy: View Source
● Our feasibility study in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive malignant brain tumor: View Source
● Our pilot study in patients with locally recurrent prostate cancer: View Source
We are proud of our incredibly comprehensive clinical program, with Alpha DaRT being evaluated simultaneously across a number of indications. Our strategy of parallel exploration of multiple cancer types provides several opportunities for potential regulatory approval while seeking to demonstrate the platform’s broad applicability.
In addition, the Company has trials approved in France and Italy and is planning a large potential basket trial in the UK to evaluate our Alpha DaRT across numerous cancer types, alongside a number of ongoing feasibility studies in Israel. In particular, I would cite the ongoing trials in Israel treating patients with tumors of the prostate, lung and pancreas, as well as our TARGETS trial, which is open to patients with any type of malignant tumors of up to 7 cm in length, in lieu of ad hoc compassionate use treatments.
We also continue to maintain open and ongoing dialogue with the FDA, including in the context of regular quarterly meetings, as we continue to explore new potential applications and more comprehensive U.S. trials of the Alpha DaRT.
Continued Clinical Validation and Upcoming Milestones Across Expanded Indication Set
As you all know, the Company started its clinical evaluations by treating superficial tumors as a proof of concept, i.e., tumors of the skin or head and neck, and has acquired significant experience in the U.S., Europe, Japan and Israel. More recently, we have started receiving results from trials in internal organs, primarily pancreatic cancer, and continue to be encouraged by the potential of Alpha DaRT to deliver a potent but conformal dose of alpha radiation to a very a broad set of tumors with poor or no available alternatives.
Targeting Completion of Patient Recruitment in Pancreatic Cancer Study End of Q1 2026
In light of the encouraging data from the Company’s first-in-human studies in Canada and Israel in patients with pancreatic cancer, which was initially read out in interim form last year (View Source) and then recently reported from the Canadian study in more detail at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (View Source), we continue to conduct our IMPACT study with great clinician and patient interest, and are targeting the completion of patient accrual at the end of the first quarter of 2026 and initial results by the end of the year.
Expecting Initial GBM Results Around End of Q4 2026
Recently we reported the treatment of our first patient in GBM at Ohio State University (View Source). Per the protocol and in line with our conservative approach to carefully watching for any safety signals, we will limit our treatments to one patient per month for the first three patients, all at Ohio State University. To the extent that no safety concerns arise, we would anticipate the removal of enrollment restrictions as well as expansion to New York University as a second site in the trial, in which case we would target the completion of patient accrual for ten patients later in the year, with initial results targeted around year end 2026.
Potential Regulatory Approval in Japan
In addition, the Company is anticipating a response shortly from Japan’s Ministry of Health, Labour and Welfare regarding our application for approval of Alpha DaRT in the treatment of recurrent head & neck cancer. We are preparing for potential post-marketing surveillance requirements in Japan should the response be positive. A positive regulatory decision in Japan would mark Alpha DaRT’s first commercial approval outside of Israel, further validating our technology and regulatory strategy.
Alpha DaRT as a Combination Therapy with Checkpoint Inhibitors
The Company also anticipates exploring an additional clinical trial with the FDA in 2026, examining the combination of Alpha DaRT with checkpoint inhibitor therapeutics for patients with locally advanced or metastatic head & neck squamous cell carcinoma, on the back of fantastic interim data we released last year from a similar study conducted in Jerusalem, and we are hoping that this will become our sixth active trial in parallel in the U.S. We reported interim results in January 2025 from the clinical study conducted in Israel in this use case (View Source). This trial is incredibly important from a strategic perspective, as it reaches a very special population and also looks to demonstrate broader systemic relevance of Alpha DaRT treatment. While the majority of our clinical trials focus on the first two of our strategic pillars of focus (localized & unresectable tumors, and tumors of high unmet need), this is our first foray into exploring our third strategic pillar, the potential use of Alpha DaRT to provide systemic benefits to patients with metastatic tumors.
In parallel, the Company is also engaged in significant pre-clinical work in partnership with leading academic institutions, including Mayo Clinic, McGill University, Emory University and MD Anderson Cancer Center, exploring different combinations with immunotherapy, which we see as an important future direction for use of Alpha DaRT.
As such, we expect an incredibly busy year in 2026 from a clinical perspective, including significant data readouts from our ReSTART pivotal trial and trials in cancers of internal organs.
Commercial and Operational Readiness
We see tremendous importance to generating additional data on the use of Alpha DaRT in tumors of internal organs such as the pancreas and the brain, in order to support future decisions on launch sequencing in different indications. As we have reported in the past, we expect to complete recruitment of the ReSTART study in this quarter, and have started to submit modules of our Modular PMA to the FDA (View Source), and expect to complete the submission toward year end. Therefore, launch sequencing continues to present interesting strategic questions in light of the broad applicability of Alpha DaRT.
As we have reported in the past, the Company is currently manufacturing Alpha DaRT treatments in Jerusalem and Thorium-228 generators in Lawrence, MA, at a scale that can supply our clinical trials, validations and pre-clinical work. However, we have also reported the receipt of a radioactive license for the first phase of our Hudson, NH facility, which is being built in phases (View Source), and are currently working on equipping that first phase with the equipment needed for Alpha DaRT manufacturing.
At the same time, we continue to build out and adjust our organizational structure to prepare for future commercialization, including investments in scaling up manufacturing, in devices and accessories for mass production such as injection molds, in robotics and automation, and in development of new manufacturing methods that will increase our output and efficiency.
Well Financed and Positioned for Execution
Our cash burn rate has remained fairly stable to date other than some minor peaks associated with investment into our manufacturing capacity, and we remain confident that we can continue to execute on our current plans.
We continue to vigorously seek protection of our intellectual property, which we see as an important fruit of the extensive labors of our R&D teams, and key to protecting our future commercial potential. In 2025 alone, we filed over 60 new patent applications of different types around the world and were granted or allowed nearly 50 patents around the world.
In light of increasing recognition of the relevance of Alpha DaRT to the broader radiotherapy and oncology therapeutics landscapes, we see increased strategic dialogue with potential partners, across a number of potential areas for collaboration. We continue to entertain a number of interesting conversations, while not losing sight of our core focus on executing on our strategy.
(Press release, Alpha Tau Medical, JAN 29, 2026, View Source [SID1234662346])