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Alpha Tau (NASDAQ: DRTS) to review early REGAIN glioblastoma trial data

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Alpha Tau Medical Ltd. is hosting a conference call and webcast on May 11, 2026 at 8:30am ET to discuss interim clinical data from the first three patients treated in its U.S. REGAIN trial for recurrent glioblastoma. The REGAIN study is a feasibility and safety trial expected to enroll up to ten U.S. patients with recurrent glioblastoma that cannot be surgically removed and have previously received central nervous system radiation. Alpha Tau develops Alpha DaRT, which delivers radium‑224 directly into solid tumors so its short‑lived decay products emit high‑energy alpha particles aimed at destroying tumor tissue while sparing nearby healthy tissue.

Positive

  • None.

Negative

  • None.
Conference call time May 11, 2026 at 8:30am ET Timing of REGAIN interim data webcast
Initial patients discussed First three patients Interim REGAIN trial data set for call
Planned REGAIN enrollment Up to ten U.S. patients Target size of recurrent glioblastoma trial
recurrent glioblastoma medical
"its U.S. trial of Alpha DaRT for patients with recurrent glioblastoma (GBM)"
Recurrent glioblastoma is a form of aggressive brain cancer that has returned or progressed after initial treatment, such as surgery, radiation or chemotherapy. It matters to investors because it represents a high unmet medical need with limited treatment options, so successful new therapies can change patient outcomes, command premium prices, and drive clinical, regulatory and commercial value—while failures carry significant clinical and financial risk.
Alpha DaRT medical
"the developer of the innovative alpha-radiation cancer therapy Alpha DaRT"
Diffusing Alpha-emitters Radiation Therapy medical
"Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent"
forward-looking statements regulatory
"This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995."
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
feasibility and safety medical
"The primary objective of the study is to evaluate the feasibility and safety of the treatment"
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 6-K

 

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO SECTION 13A-16 OR 15D-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of May 2026

 

Commission File Number: 001-41316

 

 

 

Alpha Tau Medical Ltd.

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

Kiryat HaMada St. 5

Jerusalem, Israel 9777605

+972 (3) 577-4115

(Address of principal executive offices)

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒         Form 40-F

 

 

 

 

 

 

CONTENTS

 

On May 8, 2026, Alpha Tau Medical Ltd. (the “Company”) issued a press release titled “Alpha Tau to Host Conference Call to Discuss Interim Results from First Three Patients Treated for Recurrent Glioblastoma.” 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.

 

1

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
99.1   Press release dated May 8, 2026.

 

2

 

 

SIGNATURES

 

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.

 

  Alpha Tau Medical Ltd.
     
Date: May 8, 2026 By: /s/ Uzi Sofer
    Uzi Sofer
    Chief Executive Officer

 

3

 

Exhibit 99.1

 

Alpha Tau to Host Conference Call to Discuss Interim Results from First Three Patients Treated for Recurrent Glioblastoma

 

Jerusalem, May 8, 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 it will host a conference call and webcast on Monday, May 11, 2026 at 8:30am ET to discuss interim clinical data from the first three patients treated in its U.S. trial of Alpha DaRT for patients with recurrent glioblastoma (GBM), also known as the REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial.

 

Conference Call and Webcast Details

 

·Date: Monday, May 11, 2026

 

·Time: 8:30am ET

 

·Web Access: https://alpha-tau-interim-results-conference-call.open-exchange.net/

 

An archived webcast will be available following the event.

 

About the REGAIN Study

 

The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma 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. 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, including the REGAIN study,, 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

 

FAQ

What did Alpha Tau Medical (DRTS) announce in this Form 6-K?

Alpha Tau Medical announced a conference call and webcast to discuss interim data from the first three patients in its REGAIN trial for recurrent glioblastoma, highlighting early clinical experience with its Alpha DaRT alpha-radiation therapy in a difficult brain cancer setting.

When will Alpha Tau’s REGAIN trial conference call take place?

The REGAIN trial conference call will be held on May 11, 2026 at 8:30am ET. Alpha Tau will review interim clinical data from the first three recurrent glioblastoma patients treated with its Alpha DaRT therapy during this webcasted event.

What is the REGAIN trial that Alpha Tau Medical is running?

The REGAIN trial is a U.S. clinical study of Alpha DaRT in recurrent glioblastoma, expected to enroll up to ten patients. It focuses on individuals whose tumors cannot be surgically removed and who previously received central nervous system radiation therapy.

What is Alpha DaRT therapy developed by Alpha Tau Medical?

Alpha DaRT, or Diffusing Alpha-emitters Radiation Therapy, delivers radium-224 sources directly into solid tumors. As radium decays, short-lived daughters emit high-energy alpha particles designed to destroy tumor cells while limiting radiation exposure to surrounding healthy tissue.

What is the primary goal of Alpha Tau’s REGAIN glioblastoma study?

The primary goal of the REGAIN study is to evaluate the feasibility and safety of Alpha DaRT in recurrent glioblastoma patients. The trial builds on promising pre-clinical results and will assess how the intratumoral alpha-radiation treatment performs in this initial U.S. patient group.

What type of company is Alpha Tau Medical (DRTS)?

Alpha Tau Medical is an Israeli oncology therapeutics company founded in 2016 that focuses on research, development and potential commercialization of Alpha DaRT. Its technology, developed at Tel Aviv University, targets solid tumors using localized alpha-radiation delivered directly inside the tumor mass.

Filing Exhibits & Attachments

1 document