Alpha Tau (DRTS) wins AHNS podium slot for Alpha DaRT and pembrolizumab head and neck cancer study

Rhea-AI Filing Summary

Alpha Tau Medical Ltd. reported that an abstract from its clinical trial combining its Alpha DaRT intratumoral alpha-radiation therapy with pembrolizumab in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma has been accepted for a podium presentation at the AHNS 12th International Conference on Head and Neck Cancer in Boston in July 2026.

The trial, conducted at Hadassah Medical Center in Jerusalem, evaluates Alpha DaRT as an add-on to standard-of-care immunotherapy, aiming to offer a new option for older patients who often cannot tolerate aggressive chemoradiation. Company executives and the lead investigator highlight prior monotherapy safety data and the scientific rationale for combining localized radiotherapy with systemic immunotherapy.

Key Terms

Alpha DaRT, pembrolizumab, head and neck squamous cell carcinoma, immune checkpoint inhibitors, +1 more

5 terms

Alpha DaRT medical

"developer of the innovative alpha-radiation cancer therapy Alpha DaRT"

pembrolizumab medical

"combination with pembrolizumab in elderly patients with locally advanced"

A cancer immunotherapy drug that helps the body’s immune system recognize and attack tumor cells by blocking a molecular “brake” that tumors use to hide. Investors watch it because regulatory approvals, clinical trial results, dosing rules, and competition directly affect potential sales, profit forecasts, and the valuation of companies that sell or license the drug—think of trial outcomes as checkpoint signs that can open or close a revenue road.

head and neck squamous cell carcinoma medical

"elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma"

A type of cancer that starts in the thin, flat cells that line the mouth, throat, voice box and upper airway; imagine the lining like roof shingles that, when damaged, can grow into a harmful lump. It matters to investors because its diagnosis, treatment options and regulatory approvals drive demand for drugs, tests and therapies—affecting clinical trial outcomes, market size, company valuations and the financial risk/reward of healthcare investments.

immune checkpoint inhibitors medical

"While the emergence of immune checkpoint inhibitors has expanded the therapeutic landscape"

Drugs that release the immune system’s natural “brakes,” allowing immune cells to recognize and attack cancer cells; imagine taking the safety off a guard dog so it can chase intruders. They matter to investors because they can become high-value treatments with large sales potential, but their commercial success depends on clinical trial results, regulatory approval, competition and side-effect management, which all affect a company’s valuation.

forward-looking statements regulatory

"This press release includes “forward-looking statements” within the meaning"

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.

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Form 6-K: How Foreign Companies Report to the SEC →

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 5, 2026, Alpha Tau Medical Ltd. (the “Company”) issued a press release titled “Alpha Tau Announces Upcoming Podium Presentation at the AHNS 12th International Conference on Head and Neck Cancer Showcasing Study Results of Alpha DaRT® Head and Neck Cancer Combination with Pembrolizumab.” 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.

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EXHIBIT INDEX

Exhibit No.		Description
99.1		Press release dated May 5, 2026.

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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 5, 2026	By:	/s/ Uzi Sofer
		Uzi Sofer
		Chief Executive Officer

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Exhibit 99.1

Alpha Tau Announces Upcoming Podium Presentation at the AHNS 12^th International Conference on Head and Neck Cancer Showcasing Study Results of Alpha DaRT^® Head and Neck Cancer Combination with Pembrolizumab

- Abstract from trial evaluating Alpha DaRT^® in combination with pembrolizumab in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma selected for podium presentation -

- The AHNS International Conference on Head and Neck Cancer is widely recognized as one of the premier global forums dedicated to advancing head and neck oncology -

- Clinical trial builds on Alpha DaRT monotherapy data generated across clinical studies in the United States, Europe, Israel, and Japan, and marks a key milestone in the Company’s combination therapy strategy -

- Head and neck cancer is the sixth most common malignancy worldwide, with elderly patients facing particularly limited treatment options and poor outcomes -

Jerusalem, May 5^th, 2026 - Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) (“Alpha Tau”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT^®, today announced that an abstract entitled “Management of Locally Advanced and Metastatic Head and Neck Squamous Cell Carcinoma in Elderly Patients Using Diffusing Alpha-Emitter Radiation Therapy in Combination with Pembrolizumab” has been accepted for podium presentation at the American Head and Neck Society (“AHNS”) 12^th International Conference on Head and Neck Cancer, taking place July 18-22, 2026, in Boston, Massachusetts. The presentation is scheduled to occur during the Proffered Papers session on Radiation and Adjuvant Therapies on Tuesday, July 21, 2026, 10:30 AM - 12:00 PM.

The AHNS International Conference on Head and Neck Cancer is one of the world’s premier forums dedicated to advancing multidisciplinary head and neck oncology, bringing together leading surgeons, oncologists, and researchers from across the globe. Selection for a podium presentation represents one of the highest distinctions at the conference, reserved for abstracts of particular scientific merit and clinical significance.

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common malignancy worldwide, with approximately 25-40% of patients diagnosed at age 70 or older. Elderly patients with locally advanced or metastatic disease face a particularly significant unmet medical need, as they are often ineligible for or unable to tolerate aggressive multimodal therapies, and available treatment options for this vulnerable population are associated with suboptimal survival outcomes. While the emergence of immune checkpoint inhibitors has expanded the therapeutic landscape for HNSCC, there remains a compelling rationale for combining localized intratumoral treatments with systemic immunotherapy to potentially enhance immune activation and improve clinical outcomes, particularly in patients for whom conventional approaches carry unacceptable toxicity.

The accepted abstract presents complete top-line data from a clinical study conducted at Hadassah Medical Center in Jerusalem, Israel, evaluating Alpha DaRT in combination with pembrolizumab in elderly patients with locally advanced and metastatic HNSCC, from which interim data had previously been presented at the Company’s R&D Day in January 2025. This study represents a natural evolution of Alpha Tau’s head and neck cancer program, building on a foundation of strong monotherapy data generated across clinical studies in the United States, Europe, Israel, and Japan. Preclinical research has strongly suggested that Alpha DaRT treatment may activate an immune response, providing a scientific rationale for combining it with checkpoint immunotherapy. In this combination approach, Alpha DaRT is designed to act as a localized intratumoral add-on to the patient’s standard-of-care immunotherapy regimen, without altering or interrupting the ongoing systemic treatment.

Uzi Sofer, CEO of Alpha Tau, stated, “The selection of our combination therapy abstract for a podium presentation at the AHNS International Conference is a strategic milestone for Alpha Tau. Our head and neck cancer program has matured significantly over recent years, with monotherapy studies across the United States, Europe, Israel, and Japan consistently demonstrating the strong safety profile of Alpha DaRT. Moving into combination with immunotherapy is a natural and deliberate next step in our strategy. Head and neck cancer remains a devastating disease with a profound burden on patients and their families, particularly for elderly patients who have limited treatment options and face poor prognoses. We believe the combination of a targeted intratumoral radiotherapeutic approach with systemic immunotherapy represents a highly promising frontier, and we are committed to advancing Alpha DaRT toward becoming a meaningful treatment option for these patients.”

Prof. Aron Popovtzer, MD, Director of the Sharett Institute of Oncology at Hadassah Medical Center and the lead Principal Investigator for Alpha DaRT clinical studies at Hadassah, commented, “The patient population in this study - elderly patients with locally advanced or metastatic head and neck squamous cell carcinoma - represents one of the most challenging groups in oncology. These patients often cannot tolerate aggressive chemoradiation, and their treatment options are severely limited. The procedure itself is straightforward, and Alpha DaRT is delivered as an add-on to the patient’s ongoing standard-of-care immunotherapy without requiring any changes to their existing treatment regimen. I look forward to presenting these data at the AHNS conference and to discussing the potential of this combination approach with colleagues from around the world.”

Robert B. Den, MD, Chief Medical Officer of Alpha Tau, stated, “This podium presentation at AHNS is an exciting achievement for our combination therapy program. The clinical trial landscape in head and neck cancer is increasingly focused on combining localized and systemic therapies to enhance immune activation, and numerous studies are exploring different intratumoral approaches alongside checkpoint inhibitors. What differentiates Alpha DaRT in this space is its safety profile: Across all of our head and neck cancer studies to date, we have generally observed acute, low-grade toxicities associated with Alpha DaRT, with no chronic effects reported. For patients and physicians alike, this is a critical consideration - the ability to add a potent intratumoral treatment without compounding the toxicity burden of existing systemic therapy. We believe this combination approach opens a compelling new pathway for patients who currently have very few options.”

About Alpha DaRT^®

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal intratumoral treatment of solid tumors. Alpha DaRT sources are inserted directly into the tumor, where they release short-lived therapeutic particles that disperse locally with the goal of destroying the tumor. Since the therapeutic effect is confined to a short distance, Alpha DaRT aims to mainly affect the tumor and to spare the healthy tissue around it.

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.

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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 head and neck cancer patients, including the potential benefits and associated risks, future applications and uses, the combination with pembrolizumab, and potential indication approvals, 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

3

FAQ

What did Alpha Tau Medical (DRTS) announce in its May 2026 Form 6-K?

Alpha Tau Medical announced that a clinical trial abstract on Alpha DaRT combined with pembrolizumab in elderly head and neck cancer patients was accepted for podium presentation at the AHNS 12th International Conference on Head and Neck Cancer in Boston in July 2026, highlighting complete top-line study data.

What patient population is featured in Alpha Tau Medical’s Alpha DaRT and pembrolizumab trial?

The trial focuses on elderly patients with locally advanced or metastatic head and neck squamous cell carcinoma. These patients often cannot tolerate aggressive chemoradiation and face limited treatment options and poor outcomes, making them a high-unmet-need group for potential combination approaches using localized radiation plus immunotherapy.

How is Alpha DaRT used in combination with pembrolizumab in the Alpha Tau (DRTS) study?

In the study, Alpha DaRT is delivered as a localized intratumoral add-on to the patient’s ongoing standard-of-care immunotherapy with pembrolizumab. It is designed not to interrupt or change systemic treatment, potentially enhancing immune activation while aiming to avoid significantly increasing overall toxicity burdens.

Why is the AHNS 12th International Conference podium presentation important for Alpha Tau Medical?

The AHNS International Conference is described as a premier global forum for head and neck oncology, and podium presentations are reserved for abstracts of high scientific and clinical merit. Acceptance signals recognition of the study’s importance and gives Alpha Tau a high-visibility platform to share its combination therapy data.

What prior data support Alpha Tau’s head and neck cancer program with Alpha DaRT?

The company notes that its combination trial builds on Alpha DaRT monotherapy data from clinical studies in the United States, Europe, Israel, and Japan. Across these head and neck cancer studies, management reports generally acute, low-grade toxicities and no chronic effects, supporting its exploration as an add-on intratumoral therapy.

What risks and uncertainties does Alpha Tau highlight regarding Alpha DaRT’s future development?

Alpha Tau includes forward-looking statements that depend on factors such as obtaining regulatory approvals, limited operating history, ongoing losses, funding needs, clinical trial enrollment, potential side effects, and patent issues. It cautions that preliminary or early clinical data may not predict final results or future regulatory or commercial success.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE DATED MAY 5, 2026 16.9 KB