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 April 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 April 23, 2026, Alpha Tau Medical Ltd. (the
“Company”) issued two press releases titled “Alpha Tau Successfully Treats First Pancreatic Cancer Patient in Europe
with Alpha DaRT® in French Multicenter ACAPELLA Clinical Trial” and “Alpha Tau Announces FDA Approval of IDE Supplement
to Expand Alpha DaRT® IMPACT Trial to Patients with Pancreatic Cancer Receiving Gemcitabine with Abraxane® (Nab-Paclitaxel).”
A copy of both press releases are attached to this Form 6-K as Exhibit 99.1 and 99.2, respectively.
The information in this Report on Form 6-K, including
Exhibit 99.1 and 99.2 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.
EXHIBIT INDEX
| Exhibit No. |
|
Description |
| 99.1 |
|
Press release (ACAPELLA Clinical Trial) dated April 23, 2026. |
| 99.2 |
|
Press release (IMPACT Clinical Trial) dated April 23, 2026. |
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: April 23, 2026 |
By: |
/s/ Uzi Sofer |
| |
|
Uzi Sofer |
| |
|
Chief Executive Officer |
3
Exhibit 99.1
Alpha Tau Successfully Treats First
Pancreatic Cancer Patient in
Europe with Alpha DaRT® in French Multicenter ACAPELLA Clinical Trial
| – | ACAPELLA is the European multicenter clinical trial evaluating Alpha DaRT alpha-emitter radiotherapeutics combined with capecitabine
for inoperable LAPC patients who have completed first-line mFOLFIRINOX, a population for whom no standard consolidation therapy exists
and whose prognosis remains poor despite completing the best available systemic treatment |
| – | Approximately 30% of the estimated 140,000 Europeans diagnosed with pancreatic cancer each year present with locally advanced,
inoperable, non-metastatic disease |
| – | The trial is a key pillar of Alpha Tau’s global clinical expansion strategy in Europe, alongside the ongoing IMPACT multicenter
pancreatic cancer trial in the United States |
| – | First patient treatment at CHU Grenoble Alpes comes ahead of Digestive Disease Week (DDW) 2026 in Chicago (May 2-5), where Alpha
Tau’s pancreatic cancer program will be highlighted |
Jerusalem, April 23, 2026 - Alpha Tau Medical Ltd. (Nasdaq:
DRTS, DRTSW) (“Alpha Tau”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today
announced the successful treatment of the first patient in ACAPELLA (Alpha DaRT for CAncer of the PancrEas in Locally advanced Adenocarcinoma),
the Company’s European multicenter clinical trial evaluating Alpha DaRT combined with capecitabine for patients with inoperable
locally advanced pancreatic ductal adenocarcinoma (LAPC) who have completed first-line mFOLFIRINOX chemotherapy. The procedure was performed
at CHU Grenoble Alpes by Pr. Gaël Roth, Lead Investigator of ACAPELLA, and his team, marking the first use of Alpha DaRT for pancreatic
cancer in Europe.
Pancreatic ductal adenocarcinoma is among the most lethal malignancies
worldwide. Across Europe, approximately 140,000 new cases are diagnosed annually and nearly 132,000 deaths are recorded each year.¹
Approximately 30% of patients present with locally advanced disease - tumors that have infiltrated critical vascular structures but remain
confined without distant metastases, rendering surgery impossible.²ʾ³ This translates to an estimated 42,000 patients in
Europe and approximately 4,500 patients in France alone each year, facing a poor survival outlook. While first-line mFOLFIRINOX has extended
survival for patients who tolerate it, there is no established standard of care once induction is complete. Intensive chemotherapy cannot
be sustained indefinitely, and conversion towards surgical resection with systemic therapy alone remains rare, leaving most patients without
a treatment path forward.
Uzi Sofer, CEO of Alpha Tau, remarked: “Over forty
thousand Europeans each year are diagnosed with inoperable locally advanced pancreatic cancer, and even if there are some patients who
have managed to complete first-line chemotherapy, there remains no established next step, no standard treatment path, and an inevitable
progression for the great majority. That is the great unmet need ACAPELLA was designed to address. Together with the ongoing IMPACT multicenter
pancreatic cancer trial in the United States, the ACAPELLA trial represents Alpha Tau’s commitment to building a rigorous, global
clinical evidence base for intrapancreatic alpha-emitter radiotherapeutics to treat this terrible disease. The timing of this first patient
treatment, just ahead of Digestive Disease Week 2026 in Chicago, offers a welcome opportunity to engage with the global GI oncology community
about our exciting clinical progress.”
Pr. Gaël Roth, MD PhD, Principal Investigator and Professor
of Gastrointestinal Oncology, expert in pancreatic cancer at CHU Grenoble Alpes, stated: “Being the first center in Europe
offering access to pancreatic cancer treatment with Alpha DaRT, a new innovative device aiming to improve patients’ outcome in such
a severe disease, is both a professional honor and a scientific responsibility. The procedure itself is straightforward - Alpha DaRT sources
are delivered directly into the pancreatic tumor under real-time endoscopic ultrasound guidance, in a single session, which for patients
who have already completed months of intensive chemotherapy is a meaningful advantage. CHU Grenoble Alpes brings together the expertise
in endoscopy and GI Oncology with strong activity in clinical and translational research that a study of this kind requires. I am proud
that this European effort begins here.”
Robert Den, MD, Chief Medical Officer of Alpha Tau, commented:
“With the first ACAPELLA treatment, two multicenter trials - one in the US and now one across Europe - are now advancing simultaneously,
marking a meaningful inflection point for Alpha DaRT in pancreatic cancer. ACAPELLA targets a precisely defined patient population that
has exhausted the maximum benefit available from current systemic options yet remains inoperable, and its embedded immune biomarker program
will help us understand how intrapancreatic alpha-emitter therapy potentially reshapes the tumor immune microenvironment - a question
with significant implications for the next generation of combination strategies.”
About ACAPELLA
ACAPELLA (Alpha DaRT for CAncer of the PancrEas in Locally advanced
Adenocarcinoma, Protocol CTP-PANC-04) is a prospective, interventional, open label, single-arm multicenter clinical trial enrolling up
to 40 patients with histologically confirmed inoperable locally advanced pancreatic ductal adenocarcinoma. Eligible patients must have
received 8 to 12 cycles of first-line mFOLFIRINOX and demonstrated stable disease or tumor response per RECIST v1.1, with a target lesion
of 5 cm or less in longest diameter amenable to Alpha DaRT source implantation and an ECOG performance status of 0 to 1.
In the trial, Alpha DaRT sources are delivered directly into the tumor
under real-time endoscopic ultrasound guidance. Three days following Alpha DaRT insertion, patients initiate oral capecitabine for two
months. Tumor resectability is assessed every two months, and follow-up extends to 12 months after the Alpha DaRT procedure. The trial
is to be conducted across multiple centers in France.
The primary objective is to evaluate the safety of Alpha DaRT in combination
with capecitabine, with the primary endpoint being the incidence of device-related serious adverse events graded per CTCAE v5.0 criteria.
Secondary endpoints include objective tumor response rate (per RECIST v1.1 criteria) at 2, 4, and 6 months; overall survival and progression
free survival at 12 months; and the rate of conversion to surgical resectability, including the percentage of patients achieving R0/R1
resection. Exploratory objectives include changes in SUVmax and CA 19-9, patient reported quality of life, and evaluation of treatment-associated
changes in the tumor immune microenvironment.
Additional information about the trial can be found at: https://clinicaltrials.gov/study/NCT06755359
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.
About CHU Grenoble Alpes and its GI Oncology Department
CHU Grenoble Alpes (CHUGA) is one of France’s
leading university hospital centers and a recognized site of excellence in digestive oncology. Its Hepato-gastroenterology and Digestive
Oncology Department diagnoses and treats the full spectrum of gastrointestinal malignancies, with deep expertise in pancreatic, biliary
tract, and liver cancers. The department conducts translational and clinical research in close collaboration with the Institute for Advanced
Biosciences (IAB - INSERM U1209/CNRS UMR 5309/Université Grenoble-Alpes) and the CEA Grenoble (Team BIOMICS, UA13 INSERM/CEA Grenoble/Université
Grenoble Alpes). Gael Roth and his team coordinate and participate in numerous national and international clinical trials in GI cancers
in collaboration with pharmaceutical companies or within the FFCD and PRODIGE cooperative groups. Gael Roth also contributes to French
and European oncology networks through the EORTC hepatobiliary and pancreatic cancer task forces, the development of French guidelines
for liver, biliary tract, and pancreatic cancers and the presidency of ACABi, the French association for the study of biliary tract cancers.
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,”
“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 the ACAPELLA trial, the safety, feasibility, and efficacy of Alpha DaRT in locally advanced pancreatic cancer, the potential
for tumor conversion to resectability, and the Company’s global clinical expansion strategy, including any underlying assumptions,
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
Exhibit 99.2
Alpha Tau Announces FDA Approval of IDE Supplement
to Expand Alpha DaRT® IMPACT
Trial to Patients with Pancreatic Cancer Receiving Gemcitabine with Abraxane®
(Nab-Paclitaxel)
- IDE supplement expands trial to the other
primary standard-of-care chemotherapy for pancreatic cancer patients, alongside mFOLFIRINOX -
- IDE supplement
also expands total trial size from 30 to 40 patients -
- Study explores Alpha DaRT combined with chemotherapy
in patients with newly diagnosed unresectable locally advanced or metastatic pancreatic adenocarcinoma –
- This pilot study is a key part of Alpha Tau’s
broader strategy to bring Alpha DaRT to cancer patients with some of the highest unmet needs -
Jerusalem, April 23, 2026 - Alpha Tau
Medical Ltd. (Nasdaq: DRTS, DRTSW) (“Alpha Tau”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®
today announced that the FDA has approved an Investigational Device Exemption (IDE) supplement to its U.S. multi-center pancreatic cancer
pilot study, known as IMPACT (Intratumoral Pancreatic Alpha Combination Trial), evaluating the safety, feasibility, and efficacy
of Alpha DaRT in combination with chemotherapy for patients with newly diagnosed unresectable locally advanced or metastatic pancreatic
adenocarcinoma.
The IDE supplement expands the trial to allow ten additional newly
diagnosed patients receiving gemcitabine/nab-paclitaxel together with Alpha DaRT, five of whom with unresectable locally advanced pancreatic
cancer and five with metastatic pancreatic cancer. Together with the previous IDE approval to recruit 30 patients in this trial for treatment with Alpha DaRT together with mFOLFIRINOX, the IMPACT trial is now expected to recruit a total of 40 patients.
Uzi Sofer, CEO of Alpha Tau, stated, “Approval by the FDA to
expand this important trial is wonderful news. The trial remains a key objective of ours as we seek to progress a new treatment for such
a devastating cancer. In 2026 we are seeing increasing focus on our pancreatic cancer clinical program, with numerous presentations at
leading medical conferences. While patient recruitment and interest remain strong, and we have been on track to finish patient recruitment
for IMPACT during Q2 2026, we now expect recruitment to finish in Q3 2026 as we will need to secure clinical site approvals for the change and recruit the additional patients.”
“We see tremendous value in exploring the integration of Alpha
DaRT with gemcitabine/nab-paclitaxel chemotherapy in both locally advanced and metastatic pancreatic cancer, to investigate whether the
Alpha DART can be safely combined with systemic therapy in this setting,” commented Robert Den, MD, Chief Medical Officer of Alpha
Tau. “Expanding our trial to include patients receiving either of the leading standard-of-care first-line chemotherapies offers
us a broader potential development path to use Alpha DaRT in treating this terrible disease.”
About the IMPACT Study
The IMPACT study aims to enroll up to 40 patients, comprising 20 patients
with inoperable locally advanced disease and 20 patients with metastatic disease, across multiple centers in the U.S., Canada and Israel.
Eligible patients must have newly diagnosed, histologically confirmed
pancreatic adenocarcinoma and must be inoperable, non-irradiated, and either chemotherapy-naïve or within the first four cycles of
their initial chemotherapy regimen.
Patients will continue receiving their standard-of-care chemotherapy
throughout the study (mFOLFIRINOX or gemcitabine/nab-paclitaxel), and Alpha DaRT sources will be implanted into the primary tumor using
ultrasound-guided endoscopy. Follow-up will continue up to 6 months after enrollment.
The primary objectives of the study are to assess the feasibility of
Alpha DaRT source implantation and to evaluate its safety and tolerability, specifically monitoring for Grade 3 or higher adverse events
related to the device. Secondary objectives include evaluating local tumor response using RECIST criteria and/or volumetric imaging, measuring
time to local progression, monitoring progression-free survival and overall survival, and collecting patient-reported outcomes related
to pain control. In addition, patients with inoperable locally advanced disease will be evaluated based on the percentage
of patients who become surgically resectable after treatment with Alpha DaRT. Additional information about the IMPACT trial can be found
at https://clinicaltrials.gov/study/NCT06698458.
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,”
“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 the IMPACT trial, the safety, feasibility, and efficacy of Alpha DaRT in locally advanced or metastatic pancreatic cancer
and the Company’s global clinical expansion strategy, including any underlying assumptions, 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
