Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
On January 29, 2026, Alpha Tau Medical Ltd. (the
“Company”) issued a press release titled “Alpha Tau Issues Letter to Shareholders: Five Concurrent Trials in the U.S.
with Multiple Significant Value-Driving Milestones Ahead.” A copy of this press release is attached to this Form 6-K as Exhibit
99.1.
The information in this Report on Form 6-K, including
Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall
it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange
Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
Pursuant to the requirements of the Securities
Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
Exhibit 99.1
Alpha Tau Issues Letter to Shareholders: Five
Concurrent Trials in the U.S. with Multiple Significant Value-Driving Milestones Ahead
- Expecting very active 2026 from a clinical
perspective, including significant patient accrual completions and subsequent data readouts from ReSTART pivotal skin cancer trial as
well as trials in cancers of internal organs including the pancreas and brain -
- Ramping U.S. manufacturing for commercial
readiness -
Jerusalem, January 29, 2026 - Alpha Tau Medical
Ltd. (Nasdaq: DRTS, DRTSW) (“Alpha Tau”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®
today issued the following letter to shareholders:
Dear Shareholders,
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: https://www.clinicaltrials.gov/study/NCT05323253 |
| ● | Our multicenter study in immunocompromised patients with cSCC: https://www.clinicaltrials.gov/study/NCT06615635 |
| ● | Our IMPACT (Intratumoral Pancreatic Alpha Combination
Trial) multi-center pilot study in patients with newly-diagnosed pancreatic cancer in combination with chemotherapy: https://www.clinicaltrials.gov/study/NCT06698458 |
| ● | Our feasibility study in patients with recurrent glioblastoma multiforme
(GBM), a highly aggressive malignant brain tumor: https://www.clinicaltrials.gov/study/NCT06910306 |
| ● | Our pilot study in patients with locally recurrent prostate cancer: https://www.clinicaltrials.gov/study/NCT07290998 |
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 (https://www.alphatau.com/single-post/alpha-tau-announces-cornerstone-interim-data-across-multiple-clinical-trials-to-be-shared-at-r-d-upd)
and then recently reported from the Canadian study in more detail at the 2026 ASCO Gastrointestinal Cancers Symposium (https://www.alphatau.com/single-post/alpha-tau-reports-new-positive-results-in-two-upcoming-presentations-at-asco-gi-2026-symposium-showc),
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 (https://www.alphatau.com/single-post/alpha-tau-successfully-treats-first-patient-in-its-u-s-trial-for-patients-with-recurrent-glioblasto).
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 (https://www.alphatau.com/single-post/alpha-tau-announces-cornerstone-interim-data-across-multiple-clinical-trials-to-be-shared-at-r-d-upd).
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 (https://www.alphatau.com/single-post/alpha-tau-submits-first-pre-market-approval-module-to-the-fda-for-alpha-dart-for-the-treatment-of-r),
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 (https://www.alphatau.com/single-post/alpha-tau-announces-receipt-of-radioactive-material-license-for-its-new-hampshire-manufacturing-faci),
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.
Looking Ahead
2025 was certainly full of myriad challenges that the Company rose
to meet exceedingly well, and we expect 2026 to be a busy and challenging year too. Standing beside the excellent team we now have, from
our executives and managers to each of our employees, I am confident that G-d willing we will know how to reach the goals we have set
for ourselves and deliver outstanding successes.
Thank you for your continued support and confidence in Alpha Tau’s
mission. We look forward to sharing our continued progress throughout 2026.
Sincerely,
Uzi Sofer
Chief Executive Officer
Alpha Tau Medical Ltd.
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company
that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology
was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.
About Alpha DaRT®
Alpha DaRT (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.
Forward-Looking Statements
This letter includes “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “being,”
“will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking
statements. In addition, any statements or information that refer to expectations, beliefs, plans, including with respect to upcoming
milestones, planned trials, potential new applications and trials of the Alpha DaRT, trial preliminary results including the potential
of Alpha DaRT to be used an a broad set of tumors and related side effects, patient enrollment plans and restrictions, discussions with
the MHLW in Japan and potential results of these discussions, partnerships and engagement in pre-clinical work, manufacturing and other
efforts to increase our output and efficiency, expected financial position and execution of plans and potential future partnerships are
forward-looking. All forward-looking statements are based upon Alpha Tau’s current expectations and various assumptions. Alpha Tau
believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its
expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking
statements as a result of various important factors, including, without limitation: (i) Alpha Tau’s ability to receive regulatory
approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau’s limited operating history;
(iii) Alpha Tau’s incurrence of significant losses to date; (iv) Alpha Tau’s need for additional funding and ability to raise
capital when needed; (v) Alpha Tau’s limited experience in medical device discovery and development; (vi) Alpha Tau’s dependence
on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau’s clinical
studies to predict final study results; (viii) failure of Alpha Tau’s early clinical studies or preclinical studies to predict future
clinical studies; (ix) Alpha Tau’s ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha
Tau’s Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau’s exposure to patent infringement
lawsuits; (xii) Alpha Tau’s ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq’s
listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important
factors discussed under the caption “Risk Factors” in Alpha Tau’s annual report filed on form 20-F with the SEC on March
12, 2025, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important
factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this letter. Any
such forward-looking statements represent management’s estimates as of the date of this letter. While Alpha Tau may elect to update
such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if
subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau’s
views as of any date subsequent to the date of this letter.
Investor Relations Contact:
IR@alphatau.com
