Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
On June 11, 2026, Alpha Tau Medical Ltd. (the
“Company”) issued a press release titled “Alpha Tau Receives FDA Clearance to Complete Enrollment in REGAIN Recurrent
Glioblastoma Trial and Add Two U.S. Clinical Sites; Early Interim Results Showed 100% Local Disease Control” 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 Receives FDA Clearance to Complete
Enrollment in REGAIN Recurrent Glioblastoma Trial and Add Two U.S. Clinical Sites; Early Interim Results Showed 100% Local Disease Control
- Following the pre-specified interim safety report and overwhelming
demand from clinicians to treat patients as quickly as possible, Alpha Tau to resume recruitment immediately for the remaining seven patients
in the trial -
- Marks the latest in a series of regulatory successes in this indication,
following FDA’s recognition of Alpha DaRT’s potential through its Breakthrough Device Designation for recurrent glioblastoma
(GBM) and Alpha Tau’s selection for the FDA’s prestigious Total Product Life Cycle (TPLC) Advisory Program (TAP) -
- With approximately 14,000 Americans newly diagnosed with glioblastoma
each year and median survival after recurrence typically measured in months, Alpha DaRT® represents a potentially transformative new
treatment option for patients with highly limited alternatives –
- Two additional leading U.S. academic cancer centers are now approved
to participate in the REGAIN trial, expanding geographic access and clinical expertise for this important indication -
Jerusalem, June 11, 2026 -- Alpha Tau Medical
Ltd. (Nasdaq: DRTS, DRTSW) (“Alpha Tau”, or the “Company”), the developer of the innovative alpha-radiation cancer
therapy Alpha DaRT®, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company to proceed with enrollment
of the final seven patients in its U.S. REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial,
following the FDA’s review of a pre-specified interim safety report of the first three patients treated in the trial. The Company
intends to recommence patient recruitment immediately, on the back of tremendous clinical interest in continuing the trial.
As previously announced on May 11, 2026, interim
results at the cutoff date of May 3, 2026 from the first three patients, treated between December 2025 and March 2026 at The Ohio State
University Comprehensive Cancer Center (OSUCCC) in Columbus, Ohio, demonstrated 100% local disease control, a 67% complete response rate
as defined by Response Assessment in Neuro-Oncology (RANO) criteria, and only one associated grade 3 serious adverse event (SAE), with
no unanticipated associated SAEs observed. As of the data cut-off date, no patients had any local or distant recurrence or any residual
symptoms from the procedure.
This clearance to continue the trial is the latest
in a series of successful regulatory submissions to the FDA over more than four years with respect to exploring the use of Alpha DaRT
in treating recurrent GBM. In October 2021, the Company was awarded Breakthrough Device Designation by the FDA for Alpha DaRT in recurrent
glioblastoma, and in October 2024, the Company was accepted into the FDA’s prestigious Total Product Life Cycle (TPLC) Advisory
Program (TAP) Pilot, a highly selective program designed to expedite patient access to highly promising medical devices by providing coveted
access to FDA expertise and guidance throughout the device development process.
In parallel with the FDA’s clearance to
advance enrollment, Alpha Tau has received FDA authorization for two additional leading U.S. academic cancer centers to join the REGAIN
trial as participating sites. The addition of these centers increases the geographic reach of the REGAIN trial, with the aim to broaden
access for patients across the United States, and to bring additional multidisciplinary neuro-oncology expertise to the program.
Uzi Sofer, CEO of Alpha Tau, commented,
“Glioblastoma is one of the most devastating diagnoses in oncology and is a core strategic indication for the Company. Since the
fantastic interim results we released last month from our first three recurrent GBM treatments, clinicians have been overwhelmingly demanding
that we keep treating patients as quickly as possible. This clearance, combined with the expansion to additional leading U.S. centers,
hopefully brings us meaningfully closer to making Alpha DaRT a real option for these patients.”
“I’m very gratified by the FDA’s
review of the initial safety assessment and by its clearance to advance to full patient enrollment. What stands out in the early interim
data from our first three patients is not just the magnitude of the responses, but their consistency,” said Dr. Robert Den,
Chief Medical Officer of Alpha Tau. “In recurrent GBM, where objective response rates with most systemic therapies rarely reach double
digits, seeing two patients achieve complete disappearance of all enhancing tumor lesions on serial MRI scans as of the cutoff date, while
the third showed meaningful tumor volume reduction, is a clinically significant and encouraging pattern. The adverse event profile was
manageable: one grade 3 SAE, fully resolved, with no unanticipated toxicities. This is the kind of consistent, interpretable signal that
gives us confidence as we advance to the next set of patients.”
About the REGAIN Study
The REGAIN study is a prospective, open-label,
single-arm interventional study designed to evaluate the feasibility and safety of Alpha DaRT for the potential treatment of recurrent
glioblastoma. The clinical trial is expected to enroll up to ten U.S. patients with recurrent GBM not amenable for surgical resection
who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility
and safety of the treatment, following the Company’s promising results from pre-clinical studies. Additional information about the
trial can be found at https://www.clinicaltrials.gov/study/NCT06910306
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 press release includes “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,”
“will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking
statements. The Alpha DaRT treatment has not been approved in the US for commercialization or for use outside of an approved clinical
trial. In addition, any statements or information that refer to the Alpha DaRT treatment in GBM patients, including the expected patient
enrollment, benefits, safety, implementation, feasibility and go to market process, and other expectations, beliefs, plans, including
with respect to clinical trials, regulatory approvals and studies, 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 9, 2026, 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 press release. Any such forward-looking statements represent
management’s estimates as of the date of this press release. 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 press release.
Investor Relations Contact:
IR@alphatau.com
