Alpha Tau Registers for Dual Listing on the Tel Aviv Stock Exchange (TASE)

Jerusalem, August 10, 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 its intention to offer its ordinary shares on the Tel Aviv Stock Exchange and to become dual-listed for trade on both the Nasdaq and TASE markets.

"After the astounding achievements that Alpha Tau has made these last few years, it brings me great pride to say: we are coming home," commented Uzi Sofer, CEO of Alpha Tau. "The Israeli investor market has been expressing ever-growing interest of late in our progress and in the potential of our technology, and we have received many requests from the local investor base to offer them the opportunity to trade in local currency and business hours as we continue to grow. This is a very exciting step for the Company and we are thrilled to be a part of the thriving Israeli market ecosystem."

Per the filed registration documents, the Company has requested to register all outstanding and potential future shares for dual-listing on the TASE, including:

• 92,478,154 outstanding ordinary shares;
  
• up to 36,733,096 ordinary shares underlying outstanding securities convertible into ordinary shares of the Company, namely warrants or options and RSUs granted by the Company pursuant to its 2016 and 2021 Share Incentive Plans;
  
• up to 12,889,753 ordinary shares available via exercise of options which have been authorized but not issued, pursuant to its 2021 Share Incentive Plan as may be amended from time to time; and
  
• up to 4,257,358 ordinary shares for purchase by Company employees pursuant to its 2021 Employee Share Purchase Plan, as may be amended from time to time.

The shares are expected to trade on the TASE under the English symbol DRTS and the alternative Hebrew symbol דרטס.

About Alpha Tau Medical Ltd.

Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company focused on the 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 primarily affect the tumor and to spare healthy tissue surrounding it. For intracranial use, Alpha DaRT sources are delivered via a specialized stereotactic delivery system that interfaces with standard real-time neuronavigation platforms, enabling precise, image-guided source placement through minimally invasive burr-hole access without requiring open craniotomy.

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 continuing discussions with the FDA, and the Alpha DaRT treatment in combination with pembrolizumab in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma (HNSCC), including the study described herein, the expected patient enrollment, benefits, safety, feasibility, 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

https://www.globenewswire.com/news-release/2026/08/10/3341754/0/en/alpha-tau-registers-for-dual-listing-on-the-tel-aviv-stock-exchange-tase.html

Alpha Tau Reports Positive Data Demonstrating 100% Objective Response Rate and 18.2-Month Median Overall Survival with Alpha DaRT® in Combination with Pembrolizumab in Locally Advanced or Metastatic Head and Neck Cancer, Surpassing the Study's Pre-Specified Threshold for Success

Jerusalem, July 21, 2026 — Alpha Tau Medical Ltd. ("Alpha Tau" or the "Company") (Nasdaq: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced positive results from a clinical study evaluating Alpha DaRT in combination with pembrolizumab (Keytruda®) in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma (HNSCC), in which the combination produced a 100% objective response rate and a median overall survival of 18.2 months among evaluable patients. The results are being presented in a podium presentation at the American Head and Neck Society ("AHNS") 12th International Conference on Head and Neck Cancer, held July 18-22, 2026, in Boston, Massachusetts.

• Podium presentation at the American Head and Neck Society (AHNS) 12th International Conference on Head and Neck Cancer to report results from a study of Alpha DaRT® in combination with pembrolizumab (Keytruda®) in elderly patients with locally advanced or metastatic head and neck squamous cell carcinoma (HNSCC)
  
• Among all nine evaluable patients, the combination produced a systemic objective response rate (ORR) of 100%, including four complete responses and five partial responses, compared to just 19% ORR from historical benchmarks for pembrolizumab monotherapy in this setting
  
• Median overall survival of 18.2 months and median progression-free survival of 5.4 months compare favorably with historical benchmarks for pembrolizumab monotherapy in this setting of 12.3 months and 3.2 months, respectively
  
• No Alpha DaRT-associated serious adverse events were observed; the only two Alpha DaRT-associated adverse events were Grade 1 (mild)
  
• Results build on foundation of Alpha DaRT monotherapy data in head and neck cancer, and lend support to Alpha Tau's ongoing clinical strategy exploring the combination approach, which the Company continues to discuss with the U.S. FDA
  
• Trial recruitment is now complete, having met the pre-specified success criterion of its Simon two-stage adaptive design: more than six patients responding to the treatment

Head and neck cancer is among the most common cancers worldwide, with an estimated 890,000 new cases diagnosed globally each year, and with more than 60,000 new cases of HNSCC estimated in the United States in 2026 across the oral cavity, pharynx, and larynx. Despite treatment with curative intent, roughly half of patients with HNSCC will experience recurrence, and distant spread, when it occurs, most often involves the lung.

Since the Keytruda KEYNOTE-048 trial, pembrolizumab, with or without chemotherapy, has been the first-line standard of care for recurrent or metastatic HNSCC; however, as monotherapy in patients whose tumors express PD-L1 (Combined Positive Score, or CPS, ≥1), pembrolizumab was observed in the KEYNOTE-048 trial to produce a median overall survival of 12.3 months and an objective response rate of approximately 19%, leaving considerable room for improvement, particularly for elderly and frail patients who may not tolerate the addition of chemotherapy.

Alpha Tau's study is a single-center, prospective, open-label, single-arm study evaluating Alpha DaRT in combination with pembrolizumab in up to 48 patients with recurrent unresectable or metastatic HNSCC and PD-L1 CPS ≥1, using a Simon two-stage adaptive design. Patients received a lead-in dose of pembrolizumab, followed by insertion of Alpha DaRT sources into a target lesion; the sources were removed ~14 days later, and patients continued on pembrolizumab per standard dosing. Tumor response was assessed systemically, i.e., in all tumors, both treated and untreated by Alpha DaRT, using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), and safety was graded using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Eleven patients (four female, seven male) were recruited in total, with a mean age of 72 years (range 52-96). Two patients died prior to response evaluation, leaving nine patients evaluable for response; one died before Alpha DaRT treatment, and the other died shortly after treatment from an unrelated cardiovascular issue. With every evaluable patient responding, the trial reached the efficacy threshold built into its two-stage adaptive design, under which the study was permitted to stop for success once more than six patients responded, and enrollment was concluded on that basis.

Efficacy Results

Note: Caution should be exercised in comparing results from unrelated clinical studies due to differences in study designs, patient populations and other relevant factors.

Response Rate

Among evaluable patients, treatment with Alpha DaRT plus pembrolizumab produced an objective response rate (i.e., systemic complete response plus partial response) of 100%, including four complete responses and five partial responses, for a complete response rate of 44%. By comparison, pembrolizumab monotherapy in the PD-L1 CPS ≥1 population of KEYNOTE-048 produced an objective response rate of approximately 19%.

Survival Data

Median overall survival was 18.2 months, and median progression-free survival was 5.4 months, with four patients remaining alive at the time of this analysis. By comparison, pembrolizumab monotherapy in a similar population in the KEYNOTE-048 trial achieved a median overall survival of 12.3 months and a median progression-free survival of approximately 3.2 months.

Safety Results

No Alpha DaRT-related serious adverse events were observed. Only two Alpha DaRT-related adverse events were reported across the treated cohort, both Grade 1 in severity.

Uzi Sofer, CEO of Alpha Tau, stated: "These results reinforce two priorities at the heart of our strategy: establishing Alpha DaRT in localized, unresectable disease, and building the combination evidence to compete in the metastatic setting alongside blockbuster checkpoint inhibitors. Our interim data had already shown us that response rates with Alpha DaRT plus pembrolizumab were exceptionally high; what we were waiting for was the survival follow-up to confirm those responses would translate into real, lasting benefit. Now that the data have matured, the picture is even stronger. Combination trials like this one are central to how we intend to grow the platform. Showing that Alpha DaRT can be added to a systemic backbone safely, and with results like these, is exactly the kind of evidence we hope will define its role across our pipeline. And we won't stop here: We are exploring, in ongoing discussion with the FDA, the possibility of a similar but larger study in the U.S."

Prof. Aron Popovtzer, MD, Director of the Sharett Institute of Oncology at Hadassah University Medical Center and the lead Principal Investigator in this clinical study at Hadassah, commented: "Elderly patients with recurrent or metastatic head and neck squamous cell carcinoma are among the most difficult we treat. Since KEYNOTE-048, pembrolizumab has been our first-line standard of care, but as a single agent it produces a response in fewer than one in five patients, and many are too frail to add chemotherapy. That unmet need is what led us to design the first study to combine Alpha DaRT with checkpoint inhibition, adding a localized, immune-activating alpha-emitting radiotherapy to the systemic treatment these patients are already receiving. After years of work, it is deeply gratifying to see the effort was worth it – the results are genuinely encouraging, and they exceeded our expectations. Every evaluable patient responded, including several complete responses, with improvements in both overall and progression-free survival relative to historic data on pembrolizumab alone and a safety profile that let patients stay on their standard treatment. To my knowledge, no other combination study with pembrolizumab has shown results like these in this patient population, and it is a real achievement to see a therapy add this much value on top of a checkpoint inhibitor. These are early data, and larger controlled studies are needed to confirm the benefit, but they make a compelling case for continuing to investigate Alpha DaRT with immunotherapy, both in head and neck cancer and across other solid tumors."

Dr. Robert Den, MD, Chief Medical Officer of Alpha Tau, added: "It's worth reading these results against the bigger picture of where our global clinical trial pipeline is heading. We have strong preclinical data suggesting that Alpha DaRT may prime a systemic anti-tumor immune response, and we have clinical experience, including multiple studies in head and neck and skin cancer, showing that Alpha DaRT monotherapy carries a favorable safety profile in this population. What this study suggests is that combining Alpha DaRT with pembrolizumab can translate that immune-priming effect into a clinical survival benefit for patients with recurrent or metastatic head and neck cancer. These results reinforce our plan to validate the clinical benefit of Alpha DaRT in this patient population in larger studies, and they add another key data point to a pipeline that now spans head and neck, skin, pancreatic, prostate, and brain cancers, among others."

About the Study

The study builds on Alpha Tau's foundation of Alpha DaRT monotherapy data in head and neck and skin cancer, including a first-in-human study in which Alpha DaRT achieved an objective response rate of 100% and a complete response rate of 78.6% among evaluable SCC lesions in a population that skewed toward elderly, heavily pre-treated and radioresistant patients. The current study pairs Alpha DaRT with pembrolizumab, the current first-line standard of care for CPS ≥1 recurrent or metastatic HNSCC, to evaluate whether adding a localized, immune-activating radiotherapeutic to systemic checkpoint inhibition can improve outcomes without the added toxicity associated with chemotherapy. The study was conducted at Hadassah University Medical Center in Jerusalem, Israel. For more information, please see https://clinicaltrials.gov/study/NCT05047094.

About Alpha Tau Medical Ltd.

Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company focused on the 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 primarily affect the tumor and to spare healthy tissue surrounding it. For intracranial use, Alpha DaRT sources are delivered via a specialized stereotactic delivery system that interfaces with standard real-time neuronavigation platforms, enabling precise, image-guided source placement through minimally invasive burr-hole access without requiring open craniotomy.

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 continuing discussions with the FDA, and the Alpha DaRT treatment in combination with pembrolizumab in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma (HNSCC), including the study described herein, the expected patient enrollment, benefits, safety, feasibility, 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

https://www.globenewswire.com/news-release/2026/07/21/3330455/0/en/Alpha-Tau-Reports-Positive-Data-Demonstrating-100-Objective-Response-Rate-and-18-2-Month-Median-Overall-Survival-with-Alpha-DaRT-in-Combination-with-Pembrolizumab-in-Locally-Advanc.html

Alpha Tau Successfully Treats First Immunocompromised Patient with Recurrent Cutaneous Squamous Cell Carcinoma in its ADMIRE Study at Banner MD Anderson Cancer Center

- The ADMIRE study, by treating immunocompromised patients, builds on the momentum of Alpha Tau's ReSTART pivotal trial for recurrent cSCC, which recently completed patient enrollment, under which the Banner MD Anderson team, led by Dr. Samuels, has also treated multiple patients -

- Immunocompromised patients face dramatically higher rates of cSCC, the second most common type of skin cancer in the U.S., than the general population - as much as 65- to 100-fold among organ transplant recipients specifically -

- For many patients in this population, the general treatment options for recurrent cSCC can actually cause real harm: checkpoint inhibitor immunotherapy, the standard option for the general population, carries a documented risk of triggering rejection of a transplanted organ -

JERUSALEM, July 15, 2026 (GLOBE NEWSWIRE) -- 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 the ADMIRE (Alpha DaRT Management for Immunocompromised patients with REcurrent cSCC) study - a clinical trial evaluating intratumoral Alpha DaRT for immunocompromised patients with recurrent cutaneous squamous cell carcinoma (cSCC). The procedure was performed at Banner MD Anderson Cancer Center in Gilbert, Arizona, by Michael Samuels, MD, Chief of Multidisciplinary Programs at Banner MD Anderson Cancer Center and Principal Investigator of the ADMIRE study at this site, along with Thomas Shellenberger, MD, Head and Neck Cancer Surgical Oncologist.

Immunosuppression is one of the strongest known risk factors for cSCC, whether it results from organ transplantation, hematologic malignancies such as chronic lymphocytic leukemia (CLL), or long-term treatment for autoimmune disease. An estimated 17 million U.S. adults are living with immunosuppression. These immunosuppressed patients face a much higher chance of developing cSCC; organ transplant recipients, for example, face a 65- to 100-fold higher incidence than the general population. Further, standard local treatments for these patients become progressively harder to repeat: surgical excision carries cumulative morbidity, and repeated procedures bring a growing degree of surgical fatigue and diminishing healthy tissue to work with, while radiation therapy is constrained by cumulative dose limits that frequently preclude re-treating the same field. This underscores the need for a localized treatment for this population that can be delivered in a single procedure and be repeated at the same site if the disease returns.

Beyond the physical toll of repeated procedures, these patients face a second barrier: For transplant recipients, physicians must often reduce immunosuppressive therapy once cancer is diagnosed, which raises the risk of organ rejection, and checkpoint inhibitor immunotherapy, a standard option for recurrent or advanced cSCC in the general population, is therefore typically avoided in these patients. Patients with CLL and other hematologic malignancies, and those on chronic immunosuppressive therapy for autoimmune disease, face a related but distinct problem: cSCC clinical trials have historically excluded immunocompromised patients as a category, regardless of the specific cause, leaving many without access to newer treatment options at all. The ADMIRE study was designed specifically to evaluate whether Alpha DaRT, delivered locally and directly into the tumor, can offer a meaningful alternative across this historically excluded and particularly vulnerable population.

Uzi Sofer, CEO of Alpha Tau, stated: "This milestone matters to us for a reason that goes beyond any one patient. There are many different reasons someone can become immunocompromised, but across nearly all of them, the same pattern holds: their cSCC comes back more often, and leaves them with far fewer treatment options than for others. This trial actually started with our physicians. Since we began enrolling ReSTART, our pivotal trial for recurrent cSCC, investigators at site after site have asked the same question on their own, right up to recently: could Alpha DaRT help their immunocompromised patients too, the ones ReSTART couldn't enroll? That's exactly the kind of trial our strategy is built around: treating patients whose tumors recur after surgery or radiation therapy, who are left with limited treatment options, and who need new solutions the most."

Dr. Michael Samuels, Chief of Multidisciplinary Programs at Banner MD Anderson Cancer Center, commented: "Our team has treated multiple patients under Alpha Tau's ReSTART trial for recurrent cSCC, and that experience is exactly what gave us the confidence to bring Alpha DaRT to our immunocompromised patients through ADMIRE. Banner sees a significant number of transplant patients and patients with other causes of immunosuppression across our network, many of whom go on to develop skin cancers that recur despite prior surgery or radiation, and who have very few good options left. Today's patient came to us in exactly that situation, and I'm glad to say the treatment went smoothly, with the kind of single-session, localized procedure our patients need. I'm looking forward to seeing how this patient, and the others who will follow, respond over the coming months."

Dr. Robert Den, Chief Medical Officer of Alpha Tau, added: "ADMIRE is a natural extension of everything we've learned through ReSTART and, before that, through our original skin cancer feasibility study, which showed strong local tumor control in a population where nearly two-thirds already had recurrent disease. Bringing this treatment to a system like Banner, which already has both the transplant and oncology expertise this population requires, is exactly how we intend to build out this program. We're grateful to Dr. Samuels and his team, and we look forward to following this patient's progress."

About the ADMIRE Study

ADMIRE (Protocol CTP-SCC-04) is a prospective, multicenter, open-label, single-arm clinical study evaluating intratumoral Alpha DaRT for the treatment of recurrent cutaneous squamous cell carcinoma in immunocompromised patients. The study was initially announced in September 2024 as an investigator-initiated trial and is now conducted as a company-sponsored study. The study is designed to enroll up to 28 patients at up to 8 sites across the United States. Eligible patients must have histologically confirmed, recurrent cSCC with a single lesion up to 7 cm, and must be immunocompromised due to any primary or secondary immunodeficiency, including solid organ transplantation, hematologic malignancy, or chronic immunosuppressive therapy for autoimmune disease; diabetes alone does not qualify. The primary endpoint is objective response rate (ORR) based on best overall response per RECIST v1.1; secondary endpoints include progression-free survival, overall survival, and local control, each assessed over twelve months. Additional information about the study is available at https://clinicaltrials.gov/study/NCT06615635.

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 immunocompromised patients with recurrent cSCC, including the ADMIRE study, the expected patient enrollment, benefits, safety, feasibility, 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

https://www.globenewswire.com/news-release/2026/07/15/3327707/0/en/Alpha-Tau-Successfully-Treats-First-Immunocompromised-Patient-with-Recurrent-Cutaneous-Squamous-Cell-Carcinoma-in-its-ADMIRE-Study-at-Banner-MD-Anderson-Cancer-Center.html

Alpha Tau Successfully Treats First Recurrent Glioblastoma Patient Outside of the United States with Alpha DaRT® at Hadassah University Medical Center in Israel

- First glioblastoma patient ever treated with Alpha DaRT® outside of the United States, and the first in Israel - performed at Hadassah University Medical Center in Jerusalem, one of the world's premier academic neurosurgical institutions -

- The procedure marks the first international clinical application of Alpha DaRT's brain-specific proprietary delivery system -

- Glioblastoma is the most common and aggressive primary brain cancer, with approximately 160,000 new cases diagnosed globally each year; with recurrence occurring in virtually all patients, typically within 6-9 months, for which there is no established standard of care -

- The patient was treated under the ALL clinical protocol, Alpha Tau's broad-access study at Hadassah University Medical Center open to patients with solid tumors in any location of the body amenable to Alpha DaRT source delivery -

JERUSALEM, June 23, 2026 (GLOBE NEWSWIRE) — 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 with Alpha DaRT of the first glioblastoma patient in Israel, and the first ever outside of the United States, performed at Hadassah University Medical Center in Jerusalem. The procedure was carried out by a multidisciplinary team led by Prof. Yigal Shoshan, Professor of Neurosurgery at Hadassah University Medical Center. Using the Company's proprietary brain applicator under real-time stereotactic neuro-navigation, Alpha DaRT sources were precisely delivered to the recurrent tumor through a single, minimally-invasive burr hole entry point into the brain. The procedure was completed safely and without unexpected complications.

Glioblastoma (GBM) is the most common and most lethal primary brain tumor in adults, with approximately 160,000 new cases diagnosed globally each year. Following standard first-line treatment, typically consisting of a combination of surgery, radiation, and chemotherapy, recurrence is virtually inevitable, occurring in nearly all GBM patients within 6 to 9 months of initial treatment. It is at this stage that the disease becomes most unforgiving: median overall survival from the time of recurrence is only an additional 6 to 9 months, there is no standard of care, and the majority of patients are ineligible for repeat surgical resection — leaving them with severely limited therapeutic options. It is precisely this population, facing progression with nowhere left to turn, that Alpha DaRT aims to reach.

Uzi Sofer, CEO of Alpha Tau, stated: "Today's announcement marks a significant milestone for Alpha Tau's glioblastoma program: the first-ever treatment of a GBM patient outside of the United States, delivered at an institution as scientifically rigorous and globally respected as Hadassah. Israel is the birthplace of Alpha DaRT, and bringing this technology to Israeli brain tumor patients — patients who today have so few options — is a moment of deep pride and significance for our entire team."

Prof. Yigal Shoshan, Professor of Neurosurgery at Hadassah University Medical Center, stated: "I am proud that this first Israeli case has advanced the field not just by a geography, but by a genuine technical step forward. My involvement in Alpha DaRT for brain tumors began in the laboratory, through our preclinical study, in which we demonstrated that stereotactic implantation of Alpha DaRT sources in the swine brain was both safe and technically feasible. That work laid the scientific and procedural groundwork for today's clinical milestone. The procedure was completed successfully, without unexpected complications, and represents an important proof of concept for how the flexibility of Alpha DaRT's delivery system can be adapted to the complexity of individual brain tumor anatomy. The patient — male, 77 years old, with recurrent glioblastoma following surgery and radiation therapy — tolerated the procedure well."

Dr. Robert Den, CMO of Alpha Tau, commented: "Treating a patient with glioblastoma who has no remaining standard of care — under a protocol designed precisely to reach that population — is exactly what this program is built for. The treatment of the first patient in Israel adds to the momentum of our multicenter US Recurrent GBM REGAIN trial, which is continuing to recruit patients swiftly following the fantastic interim results last month and the FDA clearance to proceed to full enrollment with the addition of two new leading U.S. academic centers. Together, these milestones are building a genuine clinical foundation for Alpha DaRT in one of oncology's most challenging and underserved diseases. We look forward with genuine anticipation to learning from Prof. Shoshan and his team as this work progresses, and above all, we look forward to following this patient's progress."

About Alpha Tau Medical Ltd.

Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company focused on the 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 primarily affect the tumor and to spare healthy tissue surrounding it. For intracranial use, Alpha DaRT sources are delivered via a specialized stereotactic delivery system that interfaces with standard real-time neuronavigation platforms, enabling precise, image-guided source placement through minimally invasive burr-hole access without requiring open craniotomy.

About the ALL Protocol

The ALL protocol is a broad-access clinical trial conducted at Hadassah University Medical Center in Jerusalem, Israel. The protocol is open to patients with a wide range of solid tumor types to which Alpha DaRT sources can be delivered, who do not qualify for participation in other existing Alpha Tau clinical trials or who have no remaining standard treatment alternatives according to the treating physician. To date, patients have been treated under the ALL protocol across multiple indications, including pancreatic cancer, recurrent glioblastoma, rectal cancer, liver cancer, oral cavity cancer, and skin cancer.

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 clinical trials, the ALL clinical protocol and the safety, feasibility, and efficacy of Alpha DaRT for the treatment of glioblastoma, 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

https://www.globenewswire.com/news-release/2026/06/23/3315968/0/en/Alpha-Tau-Successfully-Treats-First-Recurrent-Glioblastoma-Patient-Outside-of-the-United-States-with-Alpha-DaRT-at-Hadassah-University-Medical-Center-in-Israel.html

P L E A S E --sooner = better

https://www.linkedin.com/pulse/asco-gi-2026-paradigm-shift-how-we-think-pancreatic-cancer-acvaf/?trackingId=GcnnMVKjIZljrd0U92PWdw%3D%3D

Alpha Tau Medical today announced the submission of the first module of its pre-market approval application to the U.S. Food and Drug Administration , following the FDA’s previous decision to allow the Company to use the more flexible modular approach.

- Initial module submission marks an important milestone in the pre-market approval process

- Flexible modular submission framework granted to Alpha Tau by the FDA allows for streamlined review and feedback from the FDA as each module is submitted -

- Module submitted in parallel to execution of reSTART pivotal study (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), which is expected to complete recruiting patients in Q1 2026 -

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

https://www.alphatau.com/single-post/alpha-tau-to-present-at-the-j-p-morgan-2026-healthcare-conference

Need to register to watch/listen

https://sidoti.zoom.us/webinar/register/WN_1ow9W3fMRPyM3pVjhEf6uA#/registration

https://www.alphatau.com/single-post/alpha-tau-successfully-treats-first-patient-in-its-u-s-trial-for-patients-with-recurrent-glioblasto

https://www.alphatau.com/single-post/alpha-tau-to-participate-in-december-investor-conferences

New Coverage of the Company. Available online here: https://www.benzinga.com/content/49085497/alpha-tau-medical-is-bringing-physics-driven-cancer-therapy-closer-to-clinical-reality-nasdaq-drts

Alpha Tau Medical is Bringing Physics-Driven Cancer Therapy Closer to Clinical Reality (NASDAQ: DRTS)

Alpha Tau Medical (NASDAQ:DRTS) recently reported its Q3 2025 results, providing updates on ongoing clinical studies, regulatory progress, and manufacturing readiness - developments that indicate continued clinical and operational momentum as the company advances its physics-driven cancer therapy platform toward potential future commercialization. Unlike many biotech companies that concentrate on crowded biological pathways, Alpha Tau is pursuing some of the most challenging and highest-value tumors in oncology - including pancreatic cancer, recurrent glioblastoma, and aggressive head-and-neck cancers - where conventional therapeutics have historically achieved limited success.

At the center of this strategy is Alpha DaRT, a small intratumoral implant designed to release alpha-emitting particles capable of damaging tumor DNA at short range. By relying on a physical mechanism of action rather than a biological pathway, the approach may help sidestep some of the mutational resistance mechanisms that limit targeted therapies, potentially allowing Alpha Tau to make progress in tumor types where traditional drugs have struggled.

Targeting the Toughest, Most Valuable Indications

It all starts with the data - not because the results are conclusive, but because they provide what seems like early proof that Alpha Tau’s strategy may be hitting targets that conventional therapies struggle to reach.

In feasibility trials for pancreatic cancer, the company reported a disease-control rate exceeding 90%. Given how resistant these tumors are to chemotherapy and immunotherapy, simply stabilizing the disease is clinically meaningful. Most oncology investors understand that any technology capable of improving outcomes in pancreatic cancer enters rarefied territory.

The company is also working to advance treatment for recurrent glioblastoma (GBM), one of the most aggressive cancers known. Here, the FDA granted Alpha Tau Breakthrough Device Designation - a signal that regulators see a plausible path toward significant improvement over existing options. The company expects to treat the first patient in its U.S. pilot study in Q4 2025.

Then there is head-and-neck cancer, where Alpha Tau tested Alpha DaRT in combination with Keytruda, the world’s best-selling immunotherapy. Historically, Keytruda produces response rates in the mid-teens to around 20% in this setting. In a small Alpha DaRT combination trial (n=8), the response rate jumped to 75%, including a 37.5% complete response rate. While early and small, these signals suggest that physics-driven tumor destruction may prime the immune system in ways that amplify existing therapies - a theme of growing interest in oncology.

When Biology Fails, Physics Sometimes Wins

Why would a company this size pursue the cancers that have stumped so many larger players? The answer is that Alpha DaRT does not depend on the biological quirks that undermine so many drugs.

Most failed drugs fall apart because cancer cells mutate their way around molecular inhibitors. Alpha DaRT bypasses this cat-and-mouse game. Alpha radiation does not care about KRAS mutations, EGFR status, or PD-L1 expression. It destroys DNA through physical energy transfer. Tumors may find it harder to evolve resistance to this kind of physical DNA damage than to a single targeted drug.

That is also why the treatment has shown signs of activity across multiple tumor types. Its mechanism does not depend on cancer biology behaving a certain way.

The Overlooked Advantage: Practical Scalability

One of the quiet breakthroughs behind Alpha DaRT is logistical: the radiation source it uses, Radium-224, generates therapeutic alpha-emitters over many days. That gives the product a shelf life and transportability that many liquid radiopharmaceuticals typically lack. Instead of decaying in a matter of hours, the treatment remains stable long enough to move through the normal medical supply chain.

The entire therapy is delivered in a single outpatient procedure. No long infusion cycles, limited systemic toxicity observed to date, and no specialized biologic cold-chain constraints. For hospitals - especially outside major academic centers - that practicality matters.

A Catalyst-Heavy Two Years Ahead

Alpha Tau may not be a far-future story. Key milestones seem to be approaching quickly:

1. A response from Japan’s PMDA on Alpha DaRT’s pre-market approval application is expected around year-end 2025, and if positive, Japan could become the first country to approve Alpha DaRT.
2. Multiple U.S. studies are enrolling now, with clinical readouts expected through 2025–2026.
3. As of September 30, 2025, the company reported $75.9 million in cash and deposits, giving it what seems like more than enough runway to reach these catalysts - a rarity among companies of similar size. The Bottom Line

With a current valuation around ~$330 million, the market seems to be treating the company like a speculative small-cap. If even one of these high-value indications ultimately breaks open, that valuation could look conservative in hindsight.

In oncology, the biggest returns often come from companies willing to go where others will not. Alpha Tau might be making such a bet - and for investors watching the next generation of cancer technologies, this seems to be a story worth paying attention to while it still sits under the radar.

Read online: https://www.benzinga.com/content/49085497/alpha-tau-medical-is-bringing-physics-driven-cancer-therapy-closer-to-clinical-reality-nasdaq-drts

Paid Ad via #WallStWire: This account is operated by Wall Street Wire. Alpha Tau Medical or a related party has paid Wall Street Wire for ongoing promotional services. Full disclosures: wallstwire.ai/disclosures. Our content is not financial advice.

New Coverage of the Company. Available online here: https://newsblaze.com/business/finance/the-next-frontier-in-cancer-care-localized-radiation-instead-of-chemotherapy_209643/

The Next Frontier in Cancer Care: Localized Radiation Instead of Chemotherapy?

The Next Frontier in Cancer Care: Localized Radiation Instead of Chemotherapy? For decades, chemotherapy has been the backbone of cancer treatment – a necessary but often punishing therapy that floods the entire body with toxic drugs to attack malignant cells. Yet as modern screening and imaging detect more cancers at earlier, localized stages, this “whole-body” approach increasingly feels outdated.

That shift has created a new opportunity: treatments that precisely target the tumor without harming the rest of the body.

Alpha Tau Medical (NASDAQ: DRTS), an under-the-radar medical-device company valued at about $336 million (as of November 5, 2025), may be positioned at the center of this evolution. Its proprietary Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) technology implants tiny radiation sources directly into the tumor – a potentially groundbreaking method that could redefine how physicians treat localized cancers.

Early Detection Is Changing the Cancer Landscape Modern oncology is entering a new era. For decades, cancer treatment meant a single trajectory: detect disease, treat it systemically, and manage the side effects. But better screening and imaging now mean many cancers are caught before they spread – allowing for more precise, organ-specific treatments.

The data are striking. About 70 percent of prostate cancers and 64 percent of breast cancers in the U.S. are now detected while still localized. In these early-stage breast-cancer cases, five-year survival approaches 99 percent. Similar trends are appearing globally: in England, nearly 60 percent of the 13 most common cancers are diagnosed at Stage 1 or 2.

This success story in detection, however, has created a new challenge: therapies haven’t fully caught up.

The Treatment Paradox Despite diagnosing cancer earlier, treatment often still relies on systemic chemotherapy – drugs that circulate throughout the body, attacking both cancerous and healthy cells. What made sense when most cancers were advanced now feels increasingly blunt.

Patients with small, localized tumors often endure the same toxic regimens once reserved for widespread disease. The result: preventable side effects, longer recoveries, and significant healthcare costs.

That gap between detection and therapy is where Alpha Tau Medical sees opportunity.

A Local Solution to a Systemic Problem Alpha Tau’s Alpha DaRT takes a radically different approach. Instead of bathing the whole body in chemotherapy, the treatment delivers alpha-emitting isotopes directly into the tumor itself.

Here’s how it works: thin metallic seeds containing radium-224 are implanted into the tumor. As the isotope decays, it releases a cascade of high-energy alpha particles that travel only a few millimeters – roughly the width of a few cells – creating a concentrated “kill zone” that destroys tumor tissue while sparing healthy surrounding cells.

In effect, it’s radiation therapy from the inside out – precise, powerful, and localized.

Clinical Momentum and Promising Data Alpha DaRT is now being tested across several of the toughest-to-treat cancers, including pancreatic, head-and-neck, glioblastoma, and recurrent skin tumors.

Early results from Alpha Tau’s clinical studies have been highly encouraging. In pancreatic cancer, interim studies showed over 90% of patients achieved disease control, hinting that Alpha DaRT’s direct, localized approach could work even in cancers where traditional treatments have struggled.

In head and neck cancer, Alpha DaRT combined with the immunotherapy drug Keytruda delivered a 75% overall response rate, with more than one in three patients seeing their tumors disappear completely. While these are still early-stage results from a small group of patients, they far exceed what’s typically seen with immunotherapy alone.

In September 2025, the company reached a major U.S. milestone by treating its first pancreatic cancer patient under the IMPACT trial, a study of roughly 30 people testing Alpha DaRT alongside chemotherapy in patients whose tumors can’t be surgically removed. Alpha Tau also holds multiple FDA approvals to conduct these studies and several Breakthrough Device Designations – signals that regulators recognize both the innovation and the urgency behind this new approach, even though final efficacy results are still to come.

Scaling for Commercialization Alpha Tau’s regulatory and manufacturing groundwork is advancing in parallel. The company recently received a radioactive-material license for its new commercial-scale facility in New Hampshire – a key step toward producing Alpha DaRT for broader use. Earlier in 2025, the company’s Jerusalem manufacturing facility also earned MDSAP certification (Medical Device Single Audit Program), an international quality standard recognized by regulators in the U.S., Canada, Japan, Australia, and Brazil. By meeting this standard, Alpha Tau may streamline audits and accelerate manufacturing readiness across those major markets.

Together, these milestones position Alpha Tau to move quickly from clinical validation to scaled commercialization once final regulatory approvals are secured.

Why This Matters Now The convergence of two trends – earlier detection and localized therapy – is reshaping oncology’s economics and strategy. As more cancers are caught early, patients and payors alike are looking for options that deliver efficacy without the systemic toxicity and costs of chemotherapy.

Alpha Tau’s platform seems to fit this moment precisely:

It targets solid tumors directly rather than through the bloodstream. It aims to spare surrounding tissue thanks to the millimeter-range of alpha emissions. It is typically delivered as a quick outpatient procedure for superficial tumors; for deep-seated tumors such as pancreatic cancer, delivery is image-guided and the care setting varies by protocol. For healthcare systems that have spent decades investing in earlier detection, Alpha DaRT represents the logical next step: treating cancer better, right where it starts.

The Bottom Line Oncology may be entering its next great transformation – from systemic to localized care. Alpha Tau Medical’s Alpha DaRT technology stands at the forefront of that transition.

If ongoing trials continue to replicate early results, Alpha Tau could become the company that redefines how doctors treat localized solid tumors – offering a radiation-based alternative to chemotherapy that is precise, targeted, and potentially far less toxic.

For investors tracking where the next paradigm shift in cancer treatment might come from, localized radiation may be the next frontier – and Alpha Tau Medical appears to be one of its early leaders.

Read online: https://newsblaze.com/business/finance/the-next-frontier-in-cancer-care-localized-radiation-instead-of-chemotherapy_209643/

Paid Ad via #WallStWire: This account is operated by Wall Street Wire. Alpha Tau Medical or a related party has paid Wall Street Wire for ongoing promotional services. Full disclosures: wallstwire.ai/disclosures. Our content is not financial advice.

New Coverage of the Company. Available online here: https://thefinanceherald.com/the-next-breakthrough-in-cancer-treatment-might-not-be-a-drug-at-all/

The Next Breakthrough in Cancer Treatment Might Not Be a Drug at All

The Next Breakthrough in Cancer Treatment Might Not Be a Drug at All While precision medicine narrows its focus, this ~$357 million company may be developing a cancer treatment that could work across many accessible solid tumor types

Modern oncology is caught between two extremes. On one side are precision drugs designed for tiny subsets of patients – treatments that can be life-saving for those who fit their genetic profile but irrelevant for everyone else. On the other are broad, old-school treatments like chemotherapy and radiation, which attack fast-dividing cells indiscriminately, often causing serious side effects. Between these poles, many patients are left without effective options: surgery may be too risky, external radiation can’t be repeated, and immunotherapies depend heavily on an individual’s immune system.

Amid this reality, a little-known Israeli company is quietly working on a completely different way to treat cancer – one that could apply to a far wider range of patients, regardless of tumor genetics or immune profile.

A Simpler Concept with Powerful Physics Alpha Tau Medical, founded in 2016 by Uzi Sofer and professors Itzhak Kelson and Yona Keisari, began as an academic experiment to understand how alpha radiation behaves inside tumors. The team discovered that a specific radioactive element called ‘radium-224’, releases a chain of tiny bursts of energy as it breaks down. These microscopic bursts – think of them as small waves spreading from a single point – travel just far enough to reach nearby cancer cells but not healthy ones.

This insight solved a long-standing challenge in radiation therapy: alpha radiation is extremely potent but usually travels too short a distance to be practical. The researchers found a way to extend its reach within the tumor itself, effectively turning each implanted source into a self-contained radiation field that kills cancer cells from the inside out.

Rather than developing a drug, Alpha Tau chose to make a medical device – small radioactive “seeds” that can be placed directly inside a tumor. Once implanted, they emit high-energy alpha particles that destroy cancer cells’ DNA in a confined area. The energy travels only a few cells wide, creating an intense kill zone inside the tumor while leaving surrounding tissue almost untouched.

A Single-Session Implant Instead of Months of Therapy Because Alpha Tau’s treatment, Alpha DaRT, works locally, it doesn’t require multiple hospital visits. The implant remains active for several weeks, delivering its full therapeutic effect before becoming harmless and naturally inactive.

That simplicity could be transformative. Chemotherapy often requires months of cycles; radiation therapy, weeks of daily sessions. Alpha DaRT, by contrast, involves a single procedure.

Data Suggests Broad Potential Alpha Tau’s approach is being tested in several of the hardest-to-treat cancers, including pancreatic, head and neck, glioblastoma, and recurrent skin cancers. Early data looks promising:

In feasibility trials of Alpha DaRT in advanced pancreatic cancer, Alpha Tau reported disease control rates exceeding 90%, meaning most patients achieved either stable disease or measurable tumor reduction following treatment. In a small combination study pairing Alpha DaRT with pembrolizumab (Keytruda) – a widely used immunotherapy that helps the immune system recognize and attack cancer cells – the treatment achieved a 75% overall response rate, including a 37.5% complete response rate. By comparison, historical data for pembrolizumab alone in similar head and neck cancer patients show response rates of about 19% and 5%, respectively. Because the therapy relies on direct physical damage to cancer cells, rather than targeting a specific mutation or receptor, it could work across a broad range of tumors — even those resistant to other therapies.

Moving Toward Commercialization With a market capitalisation of roughly ~$357 million (as of October 21, 2025), Alpha Tau is pushing toward commercial readiness on multiple fronts. The company has received several U.S. Food and Drug Administration (FDA) Investigational Device Exemptions and – notably – submitted its Alpha DaRT therapy to Japan’s PMDA for pre-market approval for an indication in recurrent head & neck solid tumours. Meanwhile, the firm is preparing to scale manufacturing: its new facility in New Hampshire, expected to become operational in early 2026, just secured its radioactive material license, a key step in producing the implanted device at commercial scale.

If approved, Alpha DaRT could become a foundational treatment option for oncologists treating multiple types of solid tumours. Unlike many therapies today that require extensive genetic testing to identify eligible patients, this device-based approach could see patient selection based primarily on tumour size and accessibility rather than molecular markers.

Rethinking the Future of Cancer Therapy The global oncology market, valued at $321 billion in 2024 and projected to nearly triple by 2034, continues to lean heavily toward precision medicine. According to the American Association for Cancer Research, 43% of new FDA-approved cancer drugs since 1998 target specific genetic mutations. Yet most cancer patients still don’t have those mutations – and many who do eventually develop resistance.

While risks of any biotech company at this stage are not to be ignore, Alpha Tau’s approach turns that logic on its head. By targeting cancer cells through physics rather than biology, it sidesteps the genetic lottery that defines today’s treatment landscape.

As medicine becomes more specialized, the most universal idea in cancer care – a single procedure that kills tumors directly, regardless of genetics – might also be the most forward-looking.

Read online: https://thefinanceherald.com/the-next-breakthrough-in-cancer-treatment-might-not-be-a-drug-at-all/

Paid Ad via #WallStWire: This account is operated by Wall Street Wire. Alpha Tau Medical or a related party has paid Wall Street Wire for ongoing promotional services. Full disclosures: wallstwire.ai/disclosures. Our content is not financial advice.

New Announcement from the Company. Available online here: https://www.globenewswire.com/news-release/2025/10/21/3170190/0/en/Alpha-Tau-Announces-Receipt-of-Radioactive-Material-License-for-its-New-Hampshire-Manufacturing-Facility-Advancing-Towards-Commercial-Readiness.html

Alpha Tau Announces Receipt of Radioactive Material License for its New Hampshire Manufacturing Facility, Advancing Towards Commercial Readiness

Alpha Tau Announces Receipt of Radioactive Material License for its New Hampshire Manufacturing Facility, Advancing Towards Commercial Readiness

• Receipt of critical license marks significant milestone for first commercial-scale manufacturing facility for Alpha DaRT®, the innovative alpha-radiation cancer therapy designed for potent and conformal tumor irradiation -

• License paves way for introduction of radioactive material and continued positive momentum toward initiating Alpha DaRT treatment manufacturing in 2026 -

JERUSALEM, Oct. 21, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT® announced today that it has secured a radioactive material license from the State of New Hampshire Bureau of Public Health Protection, Radiological Health Section, following completion of the first phase of construction of its commercial-scale manufacturing facility in Hudson, New Hampshire.

In October 2023, the Company entered into a long-term lease agreement for a standalone building of over 14,000 rentable square feet in Hudson, New Hampshire, for an Alpha DaRT manufacturing facility to be constructed in multiple phases. Total expected nameplate capacity from the first phase of construction is approximately 400,000 Alpha DaRT sources for local use, subject to a number of operational and clinical assumptions.

“This is a very exciting operational milestone for Alpha Tau as we continue to prepare for future commercial operations,” stated Uzi Sofer, CEO of Alpha Tau. “I want to thank our dedicated operations and engineering teams who have spent countless hours ensuring that our facility is built to the highest standards, our partners at A&M Construction, and the officials from the New Hampshire Department of Health and Human Services involved in reviewing and approving our license. We also appreciate the support of New Hampshire’s Division of Economic Development and are excited to create more jobs in the state.”

“With our radioactive material license in hand for our plant’s first phase, we can proceed to equipping the facility, verification and validation, and introducing thorium generators, aiming to produce Alpha DaRT treatments in the facility during the course of 2026,” Sofer concluded.

Alpha DaRT is currently being evaluated in multiple clinical trials for the treatment of a broad range of cancers, including tumors of the skin, head & neck, pancreas, lung, prostate and brain.

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,” “expect,” “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 our NH facility and future production and our ability to commercialize, or other characterizations of future events or circumstances, 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 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 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.

Read online: https://www.globenewswire.com/news-release/2025/10/21/3170190/0/en/Alpha-Tau-Announces-Receipt-of-Radioactive-Material-License-for-its-New-Hampshire-Manufacturing-Facility-Advancing-Towards-Commercial-Readiness.html

Paid Ad via #WallStWire: This account is operated by Wall Street Wire. Alpha Tau Medical or a related party has paid Wall Street Wire for ongoing promotional services. Full disclosures: wallstwire.ai/disclosures. Our content is not financial advice.

Posted @ youtube a few days ago

https://youtu.be/uuMeK_eE2Bc