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Investor releaseQuarter not tagged2026-08-10Alpha Tau Announces Second Quarter 2026 Financial Results and Provides Corporate Update
GlobeNewswire
Alpha Tau Announces Second Quarter 2026 Financial Results and Provides Corporate Update
- Groundbreaking interim results from the U.S. recurrent glioblastoma REGAIN trial demonstrated 100% local disease control and a 67% complete response rate, followed by FDA clearance to complete trial enrollment and to add two additional leading U.S. clinical sites - - Strategic collaboration with Tolmar to develop and commercialize Alpha DaRT® for prostate cancer in the United States, backed by a $20 million equity investment at a 25% premium, $15 million towards expanded U.S. manufacturing capacity, and up to $161.5 million in development, regulatory and commercial milestone payments for the first indication, as well as future ongoing Alpha DaRT supply agreement at 60% of net sales, subject to certain adjustments - - New pancreatic cancer data presented at Digestive Disease Week (DDW) 2026 and at the 2026 ASCO Annual Meeting demonstrated strong local disease control and encouraging median overall survival across chemotherapy-naive, second-line and heavily pretreated patient populations - - Completion of patient enrollment in the U.S. pivotal recurrent cutaneous squamous cell carcinoma (cSCC) ReSTART trial, with 88 patients enrolled, the Company’s first U.S. pivotal study to reach this milestone - - 100% objective response rate and 18.2-month median overall survival observed 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 - - Numerous additional milestones anticipated over the remainder of 2026, culminating in several of the Company’s most important clinical data readouts around year-end - - Cash, cash equivalents, short-term deposits and restricted deposits balance of $104.8 million provides runway for continued clinical advancement and commercial preparation - JERUSALEM, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (“Alpha Tau”, or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, reported second quarter 2026 financial results and provided a corporate update. “The second quarter of 2026 was without question the busiest and most consequential period in Alpha Tau’s history, and the momentum has only continued to accelerate since,” said Alpha Tau CEO Uzi Sofer. “In the space of a few weeks we reported groundbreaking interim results in recurrent glioblastoma, completed…Read full documentShow less
- Groundbreaking interim results from the U.S. recurrent glioblastoma REGAIN trial demonstrated 100% local disease control and a 67% complete response rate, followed by FDA clearance to complete trial enrollment and to add two additional leading U.S. clinical sites - - Strategic collaboration with Tolmar to develop and commercialize Alpha DaRT® for prostate cancer in the United States, backed by a $20 million equity investment at a 25% premium, $15 million towards expanded U.S. manufacturing capacity, and up to $161.5 million in development, regulatory and commercial milestone payments for the first indication, as well as future ongoing Alpha DaRT supply agreement at 60% of net sales, subject to certain adjustments - - New pancreatic cancer data presented at Digestive Disease Week (DDW) 2026 and at the 2026 ASCO Annual Meeting demonstrated strong local disease control and encouraging median overall survival across chemotherapy-naive, second-line and heavily pretreated patient populations - - Completion of patient enrollment in the U.S. pivotal recurrent cutaneous squamous cell carcinoma (cSCC) ReSTART trial, with 88 patients enrolled, the Company’s first U.S. pivotal study to reach this milestone - - 100% objective response rate and 18.2-month median overall survival observed 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 - - Numerous additional milestones anticipated over the remainder of 2026, culminating in several of the Company’s most important clinical data readouts around year-end - - Cash, cash equivalents, short-term deposits and restricted deposits balance of $104.8 million provides runway for continued clinical advancement and commercial preparation - JERUSALEM, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (“Alpha Tau”, or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, reported second quarter 2026 financial results and provided a corporate update. “The second quarter of 2026 was without question the busiest and most consequential period in Alpha Tau’s history, and the momentum has only continued to accelerate since,” said Alpha Tau CEO Uzi Sofer. “In the space of a few weeks we reported groundbreaking interim results in recurrent glioblastoma, completed enrollment in our first U.S. pivotal trial, presented compelling new pancreatic cancer survival data at both Digestive Disease Week and the ASCO Annual Meeting, and announced our first major U.S. commercial partnership. This Company continues to transform itself completely, from a single-asset clinical story into a broad, multi-indication platform with a partnered commercial pathway and a rapidly expanding global clinical footprint.” “What excites me most is that the pace is still building rather than slowing,” continued Mr. Sofer. “Since the close of the quarter, we have treated the first immunocompromised recurrent cSCC patient in our ADMIRE study at Banner MD Anderson Cancer Center, treated the first glioblastoma patient ever to receive Alpha DaRT outside of the United States, as well as our first patient to receive glioblastoma treatment using two distinct injection trajectories, both at Hadassah University Medical Center, and reported a 100% objective response rate with 18.2-month median overall survival in our head and neck combination study with pembrolizumab, surpassing that study’s pre-specified threshold for success. With REGAIN now cleared to complete enrollment across additional leading U.S. centers and ReSTART fully enrolled, we have a dense sequence of milestones ahead of us that will culminate in several of the most important data readouts in our history around the end of this year.” “We have been receiving myriad inbounds from academic and medical centers around the world, expressing interest in exploring Alpha DaRT in treating an ever broader list of cancer indications, and with that input we have identified the next key indications that will keep us busy in the coming months. In parallel, we remain focused on continually increasing our manufacturing capabilities, both in our existing facilities as well as in a new facility we aim to build for our collaboration with Tolmar.” “Our collaboration with Tolmar validates both the technology and the scale of the commercial opportunity ahead of us, and it materially strengthens our position. With a strong balance sheet of $104.8 million to support our continued momentum, we are well-resourced to press forward across every one of our strategic priorities and we aim to translate this extraordinary period of progress into meaningful impact for patients.” Recent Corporate Highlights: In July 2026, Alpha Tau reported 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), delivered in a podium presentation at the American Head and Neck Society (AHNS) 12th International Conference on Head and Neck Cancer in Boston. Among all nine evaluable patients, the combination produced a systemic objective response rate of 100%, including four complete responses and five partial responses, compared to just 19% 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 compared favorably with historical benchmarks for pembrolizumab monotherapy of 12.3 months and 3.2 months, respectively. No Alpha DaRT-associated serious adverse events were observed, and the study was stopped after the recruitment of 11 patients, having surpassed its pre-specified threshold for success. In July 2026, Alpha Tau announced the successful treatment of the first patient in its ADMIRE (Alpha DaRT Management for Immunocompromised patients with REcurrent cSCC) study, a clinical trial evaluating intratumoral Alpha DaRT in immunocompromised patients with recurrent cutaneous squamous cell carcinoma (cSCC), performed at Banner MD Anderson Cancer Center in Gilbert, Arizona. Immunosuppression is one of the strongest known risk factors for cSCC, and these patients are frequently excluded from clinical trials and often cannot safely receive checkpoint inhibitor immunotherapy. In June 2026, Alpha Tau announced the successful treatment with Alpha DaRT of the first glioblastoma patient in Israel, and the first ever such treatment outside of the United States, performed at Hadassah University Medical Center in Jerusalem. 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, and the procedure was completed safely and without unexpected complications. The patient was treated under the ALL protocol, the Company’s broad-access study at Hadassah open to patients with solid tumors in any location of the body amenable to Alpha DaRT source delivery. In June 2026, Alpha Tau announced that the FDA cleared the Company to proceed with enrollment of the final seven patients in its U.S. REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial, following the FDA’s review of a pre-specified interim safety report on the first three patients treated. Two additional leading U.S. academic cancer centers were also approved to participate in the trial, expanding geographic access and clinical expertise for this indication, and the Company recommenced patient recruitment immediately. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06910306 In June 2026, Alpha Tau and Tolmar International Ltd. announced a strategic collaboration agreement to develop and commercialize Alpha DaRT for the treatment of prostate cancer in the United States. Under the agreement, Tolmar holds exclusive rights to commercialize Alpha DaRT in the United States for prostate cancer indications for a term expected to extend for 20 years from first commercial sale, and also holds an option to expand into bladder cancer commercialization in the U.S., exercisable upon achievement of specified clinical criteria. At closing, Tolmar made a $20 million equity investment in Alpha Tau at $11.99 per share, a 25% premium to the 30-trading day volume-weighted average price prior to signature, and paid $15 million towards the construction of a new Alpha DaRT production facility in the U.S. The agreement further provides for up to $96.5 million in development and regulatory milestone payments for the initial indication and up to $65 million in commercial milestone payments. Alpha Tau will lead clinical development and be responsible for manufacturing and supply, with product sold to Tolmar at 60% of the onward net sales price, subject to certain adjustments. In June 2026, Alpha Tau announced positive overall survival and safety results from a pooled analysis of three prospective Phase I/II clinical studies evaluating Alpha DaRT in patients with pancreatic cancer, presented at the 2026 ASCO Annual Meeting. Patients treated with Alpha DaRT after first-line chemotherapy reached median overall survival of 11.2 months in metastatic disease and 11.1 months in locally advanced disease, measured from the date of trial enrollment, compared to approximately 4 to 6 months and approximately 9 months, respectively, with second-line chemotherapy based on published historical data. Treatment-associated adverse events were observed in 36% of subjects and Grade 3 or higher adverse events in 9% of subjects, with no treatment-related deaths, all Grade 3 or higher events resolved, and no chronic adverse events observed. In May 2026, Alpha Tau announced groundbreaking interim results as of May 3 from the U.S. REGAIN trial of Alpha DaRT in recurrent glioblastoma (GBM), conducted at The Ohio State University Comprehensive Cancer Center. In the first three patients treated, 100% local disease control, a 67% complete response rate (two complete responses and one stable disease with a 30% tumor reduction), and a favorable safety profile were observed, with only one associated grade 3 serious adverse event that resolved with administration of steroids. As of the data cut-off date, no patients had any local or distant recurrence or any residual symptoms from the procedure. In May 2026, Alpha Tau announced the completion of patient enrollment in its U.S. multicenter pivotal ReSTART trial of Alpha DaRT for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC), with 88 patients enrolled, making ReSTART the Company’s first U.S. pivotal study to complete enrollment - a critical milestone on the path toward potential FDA pre-market approval (PMA). Alpha DaRT has received Breakthrough Device Designation from the FDA for this indication, and the Company submitted the first module of its modular PMA application in January 2026. For more information, please see here: https://www.clinicaltrials.gov/study/NCT05323253 In May 2026, Alpha Tau treated the first patient in Italy with Alpha DaRT for locally advanced pancreatic cancer, in a feasibility and safety study conducted at the world-renowned Pancreas Institute of the University of Verona. The protocol is the first Alpha DaRT pancreatic cancer protocol worldwide to permit both endoscopic ultrasound (EUS)-guided and percutaneous delivery of Alpha DaRT sources, broadening physician access across multiple interventional specialties. In May 2026, Alpha Tau presented updated pooled results from two first-in-human pancreatic cancer trials at Digestive Disease Week (DDW) 2026, with 100% local disease control observed in evaluable patients and a favorable safety profile. The oral presentation, delivered in the Pancreatic Cancer I: Diagnosis and Treatment session, marked the first time clinical results of Alpha DaRT in pancreatic cancer have been featured at a major international gastroenterology conference. In April 2026, Alpha Tau announced FDA approval of an Investigational Device Exemption (IDE) supplement to expand its U.S. multicenter IMPACT pancreatic cancer pilot trial to include patients receiving gemcitabine with Abraxane® (nab-paclitaxel). The supplement also adds ten newly diagnosed patients - five with unresectable locally advanced and five with metastatic pancreatic adenocarcinoma - bringing total planned enrollment to 40 patients. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06698458 In April 2026, Alpha Tau successfully treated the first European pancreatic cancer patient with Alpha DaRT at CHU Grenoble Alpes, under the ACAPELLA multicenter trial in France evaluating Alpha DaRT in combination with capecitabine for patients with inoperable locally advanced pancreatic ductal adenocarcinoma who have completed first-line mFOLFIRINOX chemotherapy, a population for whom no standard consolidation therapy exists. Expected Upcoming Milestone Targets: Completion of patient recruitment in IMPACT pancreatic cancer pilot study in the U.S. in Q3 2026, with initial data targeted for late 2026 or early 2027. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06698458 Completion of patient recruitment in REGAIN recurrent GBM trial in the U.S. in the second half of 2026, with additional data expected to be released by around the end of 2026. For more information, please see here: https://clinicaltrials.gov/study/NCT06910306 First patient treated in U.S. locally recurrent prostate cancer pilot trial in the second half of 2026. For more information, please see here: https://clinicaltrials.gov/study/NCT07290998 Top-line data in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in late 2026 or early 2027. For more information, please see here: https://www.clinicaltrials.gov/study/NCT05323253 Financial Results for the Six Months Ended June 30, 2026 Research and Development expenses for the six months ended June 30, 2026 were $20.9 million, compared to $14.2 million for the same period in 2025, primarily due to increased employee compensation and benefits, including share-based compensation, increased clinical trial activity, and increased raw material purchases. Marketing expenses for the six months ended June 30, 2026 were $0.6 million, compared to $0.9 million for the same period in 2025, primarily due to decreased employee compensation and benefits. General and Administrative expenses for the six months ended June 30, 2026 were $5.7 million, compared to $3.9 million for the same period in 2025, primarily due to increased employee compensation and benefits, including share-based compensation, and higher professional fees. Financial expenses, net, for the six months ended June 30, 2026 were $41.4 million, compared to financial income, net, of $0.3 million for the same period in 2025, primarily due to the remeasurement of warrants liability as the public trading prices of the Company’s ordinary shares and publicly traded warrants rose over the period. For the six months ended June 30, 2026, the Company had a net loss of $68.8 million, or $0.76 per share, compared to a net loss of $18.8 million, or $0.25 per share, for the six months ended June 30, 2025. Balance Sheet Highlights As of June 30, 2026, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $104.8 million, compared to $76.9 million at December 31, 2025. 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 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. 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,” “aim,” “goal,” “designed to,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, milestone targets, beliefs, plans, including with respect to clinical trials and planned treatments, regulatory approvals and expected responses, strategic collaborations and the anticipated benefits thereof, plans for a new manufacturing facility, the intended therapeutic benefits or outcomes of the Company’s technology, future indication expansion, the Company’s strategic priorities and its ability to execute on them, the Company’s financial position and resources, studies, patient recruitment, projections, objectives, performance, our ability to commercialize, applications with regulatory bodies 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 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: [email protected] INTERIM CONSOLIDATED BALANCE SHEETSU.S. dollars in thousands INTERIM CONSOLIDATED BALANCE SHEETSU.S. dollars in thousands INTERIM CONSOLIDATED STATEMENTS OF OPERATIONSU.S. dollars in thousands (except share and per share data)
Investor releaseQuarter not tagged2026-06-11Alpha Tau Receives FDA Clearance to Complete Enrollment in REGAIN Recurrent Glioblastoma Trial and Add Two U.S. Clinical Sites; Early Interim Results Showed 100% Local Disease Control
GlobeNewswire
Alpha Tau Receives FDA Clearance to Complete Enrollment in REGAIN Recurrent Glioblastoma Trial and Add Two U.S. Clinical Sites; Early Interim Results Showed 100% Local Disease Control
- Following the pre-specified interim safety report and overwhelming demand from clinicians to treat patients as quickly as possible, Alpha Tau to resume recruitment immediately for the remaining seven patients in the trial - - Marks the latest in a series of regulatory successes in this indication, following FDA’s recognition of Alpha DaRT’s potential through its Breakthrough Device Designation for recurrent glioblastoma (GBM) and Alpha Tau’s selection for the FDA’s prestigious Total Product Life Cycle (TPLC) Advisory Program (TAP) - - With approximately 14,000 Americans newly diagnosed with glioblastoma each year and median survival after recurrence typically measured in months, Alpha DaRT® represents a potentially transformative new treatment option for patients with highly limited alternatives – - Two additional leading U.S. academic cancer centers are now approved to participate in the REGAIN trial, expanding geographic access and clinical expertise for this important indication - JERUSALEM, June 11, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) (“Alpha Tau”, or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company to proceed with enrollment of the final seven patients in its U.S. REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial, following the FDA’s review of a pre-specified interim safety report of the first three patients treated in the trial. The Company intends to recommence patient recruitment immediately, on the back of tremendous clinical interest in continuing the trial. As previously announced on May 11, 2026, interim results at the cutoff date of May 3, 2026 from the first three patients, treated between December 2025 and March 2026 at The Ohio State University Comprehensive Cancer Center (OSUCCC) in Columbus, Ohio, demonstrated 100% local disease control, a 67% complete response rate as defined by Response Assessment in Neuro-Oncology (RANO) criteria, and only one associated grade 3 serious adverse event (SAE), with no unanticipated associated SAEs observed. As of the data cut-off date, no patients had any local or distant recurrence or any residual symptoms from the procedure. This clearance to continue the trial is the latest in a series of successful regulatory submissio…Read full documentShow less
- Following the pre-specified interim safety report and overwhelming demand from clinicians to treat patients as quickly as possible, Alpha Tau to resume recruitment immediately for the remaining seven patients in the trial - - Marks the latest in a series of regulatory successes in this indication, following FDA’s recognition of Alpha DaRT’s potential through its Breakthrough Device Designation for recurrent glioblastoma (GBM) and Alpha Tau’s selection for the FDA’s prestigious Total Product Life Cycle (TPLC) Advisory Program (TAP) - - With approximately 14,000 Americans newly diagnosed with glioblastoma each year and median survival after recurrence typically measured in months, Alpha DaRT® represents a potentially transformative new treatment option for patients with highly limited alternatives – - Two additional leading U.S. academic cancer centers are now approved to participate in the REGAIN trial, expanding geographic access and clinical expertise for this important indication - JERUSALEM, June 11, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) (“Alpha Tau”, or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company to proceed with enrollment of the final seven patients in its U.S. REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial, following the FDA’s review of a pre-specified interim safety report of the first three patients treated in the trial. The Company intends to recommence patient recruitment immediately, on the back of tremendous clinical interest in continuing the trial. As previously announced on May 11, 2026, interim results at the cutoff date of May 3, 2026 from the first three patients, treated between December 2025 and March 2026 at The Ohio State University Comprehensive Cancer Center (OSUCCC) in Columbus, Ohio, demonstrated 100% local disease control, a 67% complete response rate as defined by Response Assessment in Neuro-Oncology (RANO) criteria, and only one associated grade 3 serious adverse event (SAE), with no unanticipated associated SAEs observed. As of the data cut-off date, no patients had any local or distant recurrence or any residual symptoms from the procedure. This clearance to continue the trial is the latest in a series of successful regulatory submissions to the FDA over more than four years with respect to exploring the use of Alpha DaRT in treating recurrent GBM. In October 2021, the Company was awarded Breakthrough Device Designation by the FDA for Alpha DaRT in recurrent glioblastoma, and in October 2024, the Company was accepted into the FDA’s prestigious Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot, a highly selective program designed to expedite patient access to highly promising medical devices by providing coveted access to FDA expertise and guidance throughout the device development process. In parallel with the FDA’s clearance to advance enrollment, Alpha Tau has received FDA authorization for two additional leading U.S. academic cancer centers to join the REGAIN trial as participating sites. The addition of these centers increases the geographic reach of the REGAIN trial, with the aim to broaden access for patients across the United States, and to bring additional multidisciplinary neuro-oncology expertise to the program. Uzi Sofer, CEO of Alpha Tau, commented, "Glioblastoma is one of the most devastating diagnoses in oncology and is a core strategic indication for the Company. Since the fantastic interim results we released last month from our first three recurrent GBM treatments, clinicians have been overwhelmingly demanding that we keep treating patients as quickly as possible. This clearance, combined with the expansion to additional leading U.S. centers, hopefully brings us meaningfully closer to making Alpha DaRT a real option for these patients." "I’m very gratified by the FDA’s review of the initial safety assessment and by its clearance to advance to full patient enrollment. What stands out in the early interim data from our first three patients is not just the magnitude of the responses, but their consistency," said Dr. Robert Den, Chief Medical Officer of Alpha Tau. "In recurrent GBM, where objective response rates with most systemic therapies rarely reach double digits, seeing two patients achieve complete disappearance of all enhancing tumor lesions on serial MRI scans as of the cutoff date, while the third showed meaningful tumor volume reduction, is a clinically significant and encouraging pattern. The adverse event profile was manageable: one grade 3 SAE, fully resolved, with no unanticipated toxicities. This is the kind of consistent, interpretable signal that gives us confidence as we advance to the next set of patients." About the REGAIN Study The REGAIN study is a prospective, open-label, single-arm interventional study designed to evaluate the feasibility and safety of Alpha DaRT for the potential treatment of recurrent glioblastoma. The clinical trial is expected to enroll up to ten U.S. patients with recurrent GBM not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment, following the Company’s promising results from pre-clinical studies. Additional information about the trial can be found at https://www.clinicaltrials.gov/study/NCT06910306 About Alpha Tau Medical Ltd. Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University. About Alpha DaRT® Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking statements. The Alpha DaRT treatment has not been approved in the US for commercialization or for use outside of an approved clinical trial. In addition, any statements or information that refer to the Alpha DaRT treatment in GBM patients, including the expected patient enrollment, benefits, safety, implementation, feasibility and go to market process, and other expectations, beliefs, plans, including with respect to clinical trials, regulatory approvals and studies, are forward-looking. All forward-looking statements are based upon Alpha Tau’s current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau’s ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau’s limited operating history; (iii) Alpha Tau’s incurrence of significant losses to date; (iv) Alpha Tau’s need for additional funding and ability to raise capital when needed; (v) Alpha Tau’s limited experience in medical device discovery and development; (vi) Alpha Tau’s dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau’s clinical studies to predict final study results; (viii) failure of Alpha Tau’s early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau’s ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau’s Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau’s exposure to patent infringement lawsuits; (xii) Alpha Tau’s ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq’s listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption “Risk Factors” in Alpha Tau’s annual report filed on form 20-F with the SEC on March 9, 2026, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau’s views as of any date subsequent to the date of this press release. Investor Relations Contact: [email protected]
Investor releaseQuarter not tagged2026-06-01Alpha Tau Announces Strong Overall Survival Results from Alpha DaRT® Pancreatic Cancer Studies Presented at 2026 ASCO Annual Meeting
GlobeNewswire
Alpha Tau Announces Strong Overall Survival Results from Alpha DaRT® Pancreatic Cancer Studies Presented at 2026 ASCO Annual Meeting
- Results reinforce the potential feasibility and safety of Alpha DaRT as a one-time, minimally invasive intratumoral treatment that fits naturally into the patient journey - - Pooled analysis of three prospective Phase I/II studies in locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) demonstrates encouraging median overall survival (mOS) across chemotherapy-naive, second-line, and heavily pretreated patient populations - - Patients treated with Alpha DaRT after 1st line chemotherapy reached median overall survival (mOS) of 11.2 and 11.1 months in metastatic and locally advanced disease, respectively, from the date of trial enrollment, compared to ~4 - 6 months for metastatic patients and ~ 9 months for locally advanced patients with second-line chemotherapy, based on published historical data - - Favorable safety profile observed across the Alpha DaRT trials, with treatment-associated adverse events reported in 36% of subjects and Grade ≥3 events in 9%, with no treatment-related deaths and no chronic toxicity; all Grade ≥3 events resolved - - Following these strong survival data, Company next turns to anticipated completion of recruitment in the multicenter U.S. IMPACT pancreatic cancer trial, which is exploring the ability of Alpha DaRT, in combination with initiation of front-line chemotherapy, to deliver a potent and focused local dose without exacerbating the harsh systemic side effects of standard chemotherapy - JERUSALEM, June 01, 2026 (GLOBE NEWSWIRE) -- 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 positive overall survival and safety results from a pooled analysis of three prospective Phase I/II clinical studies evaluating endoscopic ultrasound (EUS)-guided intratumoral Alpha DaRT treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). The results were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Pancreatic cancer remains one of the most lethal of all solid tumors, with a five-year survival rate of less than 10% and survival often measured in only months for patients with advanced disease. Treatment options are particularly limited for patients who are ineligible for chemotherapy or who have progressed through one or more line…Read full documentShow less
- Results reinforce the potential feasibility and safety of Alpha DaRT as a one-time, minimally invasive intratumoral treatment that fits naturally into the patient journey - - Pooled analysis of three prospective Phase I/II studies in locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) demonstrates encouraging median overall survival (mOS) across chemotherapy-naive, second-line, and heavily pretreated patient populations - - Patients treated with Alpha DaRT after 1st line chemotherapy reached median overall survival (mOS) of 11.2 and 11.1 months in metastatic and locally advanced disease, respectively, from the date of trial enrollment, compared to ~4 - 6 months for metastatic patients and ~ 9 months for locally advanced patients with second-line chemotherapy, based on published historical data - - Favorable safety profile observed across the Alpha DaRT trials, with treatment-associated adverse events reported in 36% of subjects and Grade ≥3 events in 9%, with no treatment-related deaths and no chronic toxicity; all Grade ≥3 events resolved - - Following these strong survival data, Company next turns to anticipated completion of recruitment in the multicenter U.S. IMPACT pancreatic cancer trial, which is exploring the ability of Alpha DaRT, in combination with initiation of front-line chemotherapy, to deliver a potent and focused local dose without exacerbating the harsh systemic side effects of standard chemotherapy - JERUSALEM, June 01, 2026 (GLOBE NEWSWIRE) -- 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 positive overall survival and safety results from a pooled analysis of three prospective Phase I/II clinical studies evaluating endoscopic ultrasound (EUS)-guided intratumoral Alpha DaRT treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). The results were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Pancreatic cancer remains one of the most lethal of all solid tumors, with a five-year survival rate of less than 10% and survival often measured in only months for patients with advanced disease. Treatment options are particularly limited for patients who are ineligible for chemotherapy or who have progressed through one or more lines of systemic therapy, where historical survival is consistently poor and few effective interventions exist. The pooled, ad-hoc analysis combined safety and efficacy data from three studies, conducted at the Jewish General Hospital, at the Centre Hospitalier de l'Université de Montréal (CHUM) in Montreal, Canada, and at the Hadassah Medical Center in Jerusalem, Israel. The analysis included all patients who received the intended Alpha DaRT treatment, with a range of patients having undergone varying lines of prior chemotherapy. Survival was analyzed using the Kaplan-Meier method and assessed by disease stage (locally advanced versus metastatic) and by number of prior chemotherapy lines (zero, one, or two). Overall Survival 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. Alpha DaRT-treated patients who had received one prior line of chemotherapy achieved a median overall survival of 17.0 months in metastatic disease and 13.8 months in locally advanced disease, from the date of initiation of the prior line of chemotherapy. Alpha DaRT as second-line therapy, measured from study enrollment, achieved an mOS of 11.2 months in metastatic patients, while in the published literature, mOS for metastatic patients with second-line chemotherapy is reported to be ~ 4-6 months (from initiation of second-line chemotherapy), and for the locally advanced patients, achieved an mOS of 11.1 months, vs. ~9 months. Alpha DaRT-treated patients who had received two prior lines of chemotherapy - a heavily pretreated population for whom there is no established standard of care - achieved a median overall survival of 17.1 months in locally advanced disease and 11.3 months in metastatic disease, from the date of initiation of the second-line chemotherapy. Alpha DaRT as third-line therapy, measured from study enrollment, achieved an mOS of 7.9 months in metastatic patients, and for the locally advanced patients, achieved an mOS of 8.8 months, while in the published literature, mOS for patients with third-line chemotherapy is reported to be ~ 4-7 months (from the initiation of third-line chemotherapy). Patients who were treated with Alpha DaRT and who had not received any prior chemotherapy demonstrated mOS of 7.1 months from diagnosis in both locally advanced and metastatic diseases, which includes mOS of 6.3 and 5.8 months, from trial enrollment, for locally advanced and metastatic patients, respectively. Safety Results Alpha DaRT was observed to have a favorable safety profile. Treatment-associated adverse events were observed in 36% of subjects, and Grade ≥ 3 adverse events were observed in 9% of subjects, including biliary obstruction, abdominal pain, fever, liver enzyme imbalance, and bacteremia. Importantly, there were no treatment-related deaths, all Grade ≥ 3 adverse events resolved, and no chronic adverse events were observed. This safety profile is especially relevant in advanced pancreatic cancer, where patients are often frail and where the cumulative toxicity of ongoing systemic therapy can significantly compromise quality of life. A key differentiator of Alpha DaRT is its potential as a one-time, minimally invasive intratumoral administration, as compared to continuous oral or intravenous therapy. Uzi Sofer, CEO of Alpha Tau, stated: "I have always believed deeply in the potential of Alpha DaRT to be highly efficacious, but I say proudly that these results exceeded even my own expectations, and are an outstanding extension of the interim results in these first-in-human trials that we observed last year. To see this level of survival, achieved with a one-time treatment and without chronic side effects, in patients who today have so little to turn to, strengthens our resolve to bring Alpha DaRT to as many of these patients as possible, as quickly as we responsibly can. These first-in-human results are fantastic, and they demonstrate the potential of Alpha DaRT as a monotherapy, even when compared to standard-of-care chemotherapies. And now we are even more excited about the treatment design of our U.S. IMPACT trial. In treating pancreatic cancer, our goal is not to replace chemotherapy or other next-generation systemic therapies, our goal is to explore whether Alpha DaRT can serve as a compelling focused local therapy and add a concurrent therapeutic boost without exacerbating the harsh systemic side effects of standard chemotherapy regimens. We are excited about the advent of new systemic therapy options for pancreatic cancer patients, and given the safety profile observed thus far for Alpha DaRT, we believe there is compelling rationale for exploring further combination trials in the future with new systemic therapies as they become standard-of-care. Pancreatic cancer is one of the cruelest diagnoses, and these patients deserve therapies that deliver not only meaningful efficacy, but also a safety profile and treatment experience that respect their quality of life and fit into their journey rather than dominate it." Corey Miller, MD, MSc, Director of Therapeutic Endoscopy of the Division of Gastroenterology at the Jewish General Hospital, Assistant Professor of Medicine at McGill University, and Principal Investigator in Canada, commented: "As the first physician in the world to deliver Alpha DaRT into the pancreas using an endoscopic ultrasound-guided approach, seeing these results is genuinely extraordinary for me. I treated some of the very first patients in this program, and that trajectory, from the early procedures all the way through to receiving the survival outcome data with no observed chronic toxicity, has been truly fantastic to witness and a privilege to be a part of." Robert Den, MD, Chief Medical Officer of Alpha Tau, added: "These pooled survival and safety data provide extremely encouraging reinforcement of our clinical strategy which we are moving decisively to execute across a broad and increasingly global clinical program. Historically, local therapy has not played a big role in treating non-resectable pancreatic cancer due to poor clinical trial results secondary to limitations on dose escalation in the pancreas in light of the sensitive organs in the area, as well as the inability to dose chemotherapy at systemic therapy levels concurrently with local therapy. We seek to make local therapy an integral part of the treatment of pancreatic cancer, without compromising the ability to deliver systemic therapy concurrently. Our flagship multicenter IMPACT trial in the United States continues to advance, evaluating Alpha DaRT in combination with chemotherapy in patients with newly diagnosed unresectable pancreatic cancer. The ACAPELLA trial in France, evaluating Alpha DaRT alongside capecitabine in patients with locally advanced pancreatic cancer, is underway following the treatment of its first patient. And our work at the prestigious University of Verona's Pancreas Institute is extending the program to include a percutaneous delivery approach, broadening the range of patients who may be able to access this therapy. Together, these studies reflect a deliberate, methodical effort to generate the rigorous evidence needed to bring Alpha DaRT to patients with one of the most significant unmet needs in oncology." About the Studies The analysis presented is a pooled ad-hoc analysis of three prospective Phase I/II clinical studies conducted at centers in Canada and Israel, evaluating EUS-guided intratumoral Alpha DaRT in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma across varying lines of prior chemotherapy. The analysis included all cases that received the intended treatment. Survival analyses used the Kaplan-Meier method, measured from the time of enrollment or from the initiation of the previous line of chemotherapy, to death, and were analyzed by disease stage and number of prior chemotherapy lines (zero, one, or two). 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 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. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. The Alpha DaRT treatment has not been approved for commercialization or for use outside of an approved clinical trial. In addition, any statements or information that refer to the Alpha DaRT treatment in pancreatic patients, including the potential benefits and associated risks, safety, future applications and uses, the IMPACT study, the ACAPELLA study, the work at the University of Verona, and potential indication approvals, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's annual report filed on form 20-F with the SEC on March 9, 2026, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release. Investor Relations Contact: [email protected]
Investor releaseQuarter not tagged2026-05-18Alpha Tau Announces First Quarter 2026 Financial Results and Provides Corporate Update
GlobeNewswire
Alpha Tau Announces First Quarter 2026 Financial Results and Provides Corporate Update
- Groundbreaking interim results from U.S. REGAIN trial in recurrent glioblastoma demonstrate 100% local disease control, 67% complete response rate, and favorable safety profile - - Completion of patient enrollment in the U.S. pivotal ReSTART trial in recurrent cutaneous squamous cell carcinoma, the Company’s first U.S. pivotal study - - Pooled data from two pancreatic cancer trials presented at Digestive Disease Week (DDW) 2026 demonstrated 100% local disease control and favorable safety, the first oral presentation of Alpha DaRT® pancreatic data at a premier international gastroenterology conference - - Abstracts accepted for presentation at the 2026 ASCO Annual Meeting and at the AHNS 12th International Conference on Head and Neck Cancer, reflecting growing scientific recognition across multiple solid tumor indications - - FDA approval of an IDE supplement to expand the IMPACT pancreatic cancer trial to patients receiving gemcitabine with Abraxane® (nab-paclitaxel) and recruit additional patients - - First patient successfully treated for pancreatic cancer in Europe at CHU Grenoble Alpes under the multicenter ACAPELLA trial in France, and first patient successfully treated in Italy at the University of Verona’s Pancreas Institute - - Cash, cash equivalents, short-term deposits and restricted deposits balance of $80.2 million provides runway for continued clinical advancement and commercial preparation - JERUSALEM, May 18, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (“Alpha Tau”, or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, reported first quarter 2026 financial results and provided a corporate update. “The first quarter of 2026 has been a truly defining period for Alpha Tau, reflecting the convergence of two powerful dynamics that have been years in the making: the maturation of clinical data from our most advanced programs, and the global initiation of novel trials addressing some of the most pressing unmet needs in oncology,” said Alpha Tau CEO Uzi Sofer. “The groundbreaking interim results from our U.S. REGAIN trial in recurrent glioblastoma, with 100% local disease control and a 67% complete response rate as of May 3, represent powerful potential clinical benefit in patients facing a devastating disease with virtually no curative options. Our pancreatic cancer program has also…Read full documentShow less
- Groundbreaking interim results from U.S. REGAIN trial in recurrent glioblastoma demonstrate 100% local disease control, 67% complete response rate, and favorable safety profile - - Completion of patient enrollment in the U.S. pivotal ReSTART trial in recurrent cutaneous squamous cell carcinoma, the Company’s first U.S. pivotal study - - Pooled data from two pancreatic cancer trials presented at Digestive Disease Week (DDW) 2026 demonstrated 100% local disease control and favorable safety, the first oral presentation of Alpha DaRT® pancreatic data at a premier international gastroenterology conference - - Abstracts accepted for presentation at the 2026 ASCO Annual Meeting and at the AHNS 12th International Conference on Head and Neck Cancer, reflecting growing scientific recognition across multiple solid tumor indications - - FDA approval of an IDE supplement to expand the IMPACT pancreatic cancer trial to patients receiving gemcitabine with Abraxane® (nab-paclitaxel) and recruit additional patients - - First patient successfully treated for pancreatic cancer in Europe at CHU Grenoble Alpes under the multicenter ACAPELLA trial in France, and first patient successfully treated in Italy at the University of Verona’s Pancreas Institute - - Cash, cash equivalents, short-term deposits and restricted deposits balance of $80.2 million provides runway for continued clinical advancement and commercial preparation - JERUSALEM, May 18, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (“Alpha Tau”, or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, reported first quarter 2026 financial results and provided a corporate update. “The first quarter of 2026 has been a truly defining period for Alpha Tau, reflecting the convergence of two powerful dynamics that have been years in the making: the maturation of clinical data from our most advanced programs, and the global initiation of novel trials addressing some of the most pressing unmet needs in oncology,” said Alpha Tau CEO Uzi Sofer. “The groundbreaking interim results from our U.S. REGAIN trial in recurrent glioblastoma, with 100% local disease control and a 67% complete response rate as of May 3, represent powerful potential clinical benefit in patients facing a devastating disease with virtually no curative options. Our pancreatic cancer program has also continued to build compelling data, first with positive new results from our Montreal study presented at the ASCO Gastrointestinal Cancers Symposium, then with the oral presentation of pooled pancreatic data at Digestive Disease Week 2026, and most recently with the expansion of our IMPACT pancreatic trial to include patients receiving gemcitabine with Abraxane® (nab-paclitaxel).” “At the same time, we have continued to make significant strides toward commercialization on both sides of the Pacific, following our receipt of PMDA marketing approval in Japan for Alpha DaRT in unresectable locally advanced or locally recurrent head and neck cancer,” continued Mr. Sofer. “In Japan, we are working closely with our selected leading clinical centers to advance the post-market surveillance study that supports our marketing approval. In the United States, we are advancing steadily along our path to potential FDA approval, with the recent completion of patient enrollment with 88 patients in our pivotal ReSTART trial, our very first U.S. pivotal study to reach this milestone.” “Taken together, this quarter is a true culmination of years of disciplined execution across each of our strategic priorities. With a strong balance sheet with $80.2 million of liquidity to support our continued momentum, we aim to translate this remarkable progress into meaningful impact for patients.” Recent Corporate Highlights: In May 2026, Alpha Tau announced groundbreaking interim results as of May 3 from the U.S. REGAIN trial of Alpha DaRT in recurrent glioblastoma (GBM), conducted at The Ohio State University Comprehensive Cancer Center. In the first three patients treated, 100% local disease control, a 67% complete response rate (two complete responses and one stable disease with a 30% tumor reduction), and a favorable safety profile were observed, with only one associated grade 3 serious adverse event that resolved with administration of steroids. The REGAIN study is expected to enroll up to ten U.S. patients with recurrent GBM not amenable to surgical resection. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06910306 In May 2026, Alpha Tau announced the completion of patient enrollment in its U.S. multicenter pivotal ReSTART trial of Alpha DaRT for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC), with 88 patients enrolled, making ReSTART the Company’s first U.S. pivotal study to complete enrollment - a critical milestone on the path toward potential FDA pre-market approval (PMA). Alpha DaRT has received Breakthrough Device Designation from the FDA for this indication, and the Company submitted the first module of its modular PMA application in January 2026. For more information, please see here: https://www.clinicaltrials.gov/study/NCT05323253 In May 2026, Alpha Tau presented updated pooled results from two first-in-human pancreatic cancer trials at Digestive Disease Week (DDW) 2026, with 100% local disease control observed in evaluable patients and a favorable safety profile. The oral presentation, delivered in the Pancreatic Cancer I: Diagnosis and Treatment session, marked the first time clinical results of Alpha DaRT in pancreatic cancer have been featured at a major international gastroenterology conference. In May 2026, Alpha Tau treated the first patient in Italy with Alpha DaRT for locally advanced pancreatic cancer, in a feasibility and safety study conducted at the world-renowned Pancreas Institute of the University of Verona. The protocol is the first Alpha DaRT pancreatic cancer protocol worldwide to permit both endoscopic ultrasound (EUS)-guided and percutaneous delivery of Alpha DaRT sources, broadening physician access across multiple interventional specialties. In May 2026, Alpha Tau announced that an abstract entitled “Management of Locally Advanced and Metastatic Head and Neck Squamous Cell Carcinoma in Elderly Patients Using Diffusing Alpha-Emitter Radiation Therapy in Combination with Pembrolizumab” was accepted for podium presentation at the AHNS 12th International Conference on Head and Neck Cancer, taking place July 18-22, 2026 in Boston. The presentation reports complete top-line data from a clinical study conducted at Hadassah Medical Center, marking a key milestone in the Company’s combination therapy strategy. In April 2026, Alpha Tau announced that an abstract entitled “Combined Safety and Efficacy Results from Three Clinical Studies Evaluating Alpha Radiotherapy for Advanced Pancreatic Cancer,” presenting a pooled analysis of 58 patients across three prospective clinical studies conducted in Canada and Israel, was accepted for presentation at the 2026 ASCO Annual Meeting taking place May 29 - June 2, 2026. The abstract is expected to be published on the ASCO conference website on May 21, 2026. In April 2026, Alpha Tau announced FDA approval of an Investigational Device Exemption (IDE) supplement to expand its U.S. multicenter IMPACT pancreatic cancer pilot trial to include patients receiving gemcitabine with Abraxane® (nab-paclitaxel). The supplement also adds ten newly diagnosed patients - five with unresectable locally advanced and five with metastatic pancreatic adenocarcinoma - bringing total planned enrollment to 40 patients. Patient recruitment is now expected to complete in Q3 2026 to allow for site approvals and additional enrollment. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06698458. In April 2026, Alpha Tau successfully treated the first European pancreatic cancer patient with Alpha DaRT at CHU Grenoble Alpes, under the ACAPELLA multicenter trial in France evaluating Alpha DaRT in combination with capecitabine for patients with inoperable locally advanced pancreatic ductal adenocarcinoma who have completed first-line mFOLFIRINOX chemotherapy, a population for whom no standard consolidation therapy exists. Expected Upcoming Milestone Targets: Completion of patient recruitment in IMPACT pancreatic cancer pilot study in the U.S. in Q3 2026, with initial data targeted for late 2026 or early 2027. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06698458 Completion of patient recruitment in REGAIN recurrent GBM trial in the U.S. in the second half of 2026, with additional data expected to be released by around the end of 2026. For more information, please see here: https://clinicaltrials.gov/study/NCT06910306 Top-line data in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma around the end of 2026. For more information, please see here: https://www.clinicaltrials.gov/study/NCT05323253 Financial Results for the Three Months Ended March 31, 2026 Research and Development expenses for the three months ended March 31, 2026 were $11.0 million, compared to $7.2 million for the same period in 2025, primarily due to increased clinical trial activity, increased employee compensation and benefits, including share-based compensation, increased raw material purchases, and milestone payments associated with our receipt of PMDA marketing authorization in Japan. Marketing expenses for the three months ended March 31, 2026 were $0.2 million, compared to $0.5 million for the same period in 2025, primarily due to decreased employee compensation and benefits and marketing conference activities. General and Administrative expenses for the three months ended March 31, 2026 were $2.1 million, compared to $1.7 million for the same period in 2025, primarily due to increased employee compensation and benefits, including share-based compensation, and higher professional fees. Financial expenses, net, for the three months ended March 31, 2026 were $9.6 million, compared to financial income, net, of $0.7 million for the same period in 2025, primarily due to the remeasurement of warrants liability. For the three months ended March 31, 2026, the Company had a net loss of $22.9 million, or $0.26 per share, compared to a net loss of $8.7 million, or $0.12 per share, for the three months ended March 31, 2025. Balance Sheet Highlights As of March 31, 2026, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $80.2 million, compared to $76.9 million at December 31, 2025. 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 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. 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 expectations, milestone targets, beliefs, plans, including with respect to clinical trials and planned treatments, regulatory approvals and expected responses, studies, patient recruitment, projections, objectives, performance, our ability to commercialize, applications with regulatory bodies 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 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:[email protected]
Investor releaseQuarter not tagged2026-05-11Alpha Tau Announces Groundbreaking Interim Results from its U.S. Alpha DaRT® Recurrent Glioblastoma Trial, with 100% Local Disease Control, 67% Complete Response Rate, and Favorable Safety Profile Observed - Conference Call Scheduled for 8:30am ET
GlobeNewswire
Alpha Tau Announces Groundbreaking Interim Results from its U.S. Alpha DaRT® Recurrent Glioblastoma Trial, with 100% Local Disease Control, 67% Complete Response Rate, and Favorable Safety Profile Observed - Conference Call Scheduled for 8:30am ET
- Interim results from the first three brain cancer patients treated; two of whom demonstrated complete response, with total disappearance of all enhancing tumor lesions, per multiple MRI scans since treatment - - One associated grade 3 serious adverse event (SAE) was observed, since resolved - - According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months - - Conference call with principal investigator to be held today, Monday, May 11, 2026, at 8:30am ET - JERUSALEM, May 11, 2026 (GLOBE NEWSWIRE) -- 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 groundbreaking interim data from its U.S. trial of Alpha DaRT for patients with recurrent glioblastoma (GBM), also known as the REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial. In accordance with the FDA’s request for an interim safety analysis, results were analyzed after three patients were treated in the trial, with one patient treated in each of December 2025, February 2026 and March 2026. No unanticipated associated SAEs have been observed as of the cutoff date of May 3, 2026, and only one associated grade 3 SAE was observed: seizure with temporary paralysis, which resolved with the administration of steroids. In addition, as measured via regular MRI scans and defined by Response Assessment in Neuro-Oncology (RANO) criteria, the first two patients demonstrated a continued complete response, signifying the total disappearance of all enhancing tumor lesions, and the third patient demonstrated stable disease with a 30% decrease in tumor dimension. As of the cutoff date, no patients have any local or distant recurrence, or any residual symptoms from the procedure, and the patient has recovered from the associated SAE. The first three patients were treated at The Ohio State University Comprehensive Cancer Center (OSUCCC) in Columbus, Ohio, by a multidisciplinary team led by Principal Investigator and Radiation Oncologist Joshua D. Palmer, MD, Medical Physicist Michael Degnan, MS, DABR and Neurosurgeon J. Bradley Elder, MD, using a novel delivery approach designed specifically by Alpha Tau for intracranial use. "Today is a very important day for Alpha T…Read full documentShow less
- Interim results from the first three brain cancer patients treated; two of whom demonstrated complete response, with total disappearance of all enhancing tumor lesions, per multiple MRI scans since treatment - - One associated grade 3 serious adverse event (SAE) was observed, since resolved - - According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months - - Conference call with principal investigator to be held today, Monday, May 11, 2026, at 8:30am ET - JERUSALEM, May 11, 2026 (GLOBE NEWSWIRE) -- 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 groundbreaking interim data from its U.S. trial of Alpha DaRT for patients with recurrent glioblastoma (GBM), also known as the REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial. In accordance with the FDA’s request for an interim safety analysis, results were analyzed after three patients were treated in the trial, with one patient treated in each of December 2025, February 2026 and March 2026. No unanticipated associated SAEs have been observed as of the cutoff date of May 3, 2026, and only one associated grade 3 SAE was observed: seizure with temporary paralysis, which resolved with the administration of steroids. In addition, as measured via regular MRI scans and defined by Response Assessment in Neuro-Oncology (RANO) criteria, the first two patients demonstrated a continued complete response, signifying the total disappearance of all enhancing tumor lesions, and the third patient demonstrated stable disease with a 30% decrease in tumor dimension. As of the cutoff date, no patients have any local or distant recurrence, or any residual symptoms from the procedure, and the patient has recovered from the associated SAE. The first three patients were treated at The Ohio State University Comprehensive Cancer Center (OSUCCC) in Columbus, Ohio, by a multidisciplinary team led by Principal Investigator and Radiation Oncologist Joshua D. Palmer, MD, Medical Physicist Michael Degnan, MS, DABR and Neurosurgeon J. Bradley Elder, MD, using a novel delivery approach designed specifically by Alpha Tau for intracranial use. "Today is a very important day for Alpha Tau. These results confirm that we are on target with pursuing our core strategy of offering new treatment possibilities to those who need it most,” commented Uzi Sofer, CEO of Alpha Tau. “Glioblastoma is one of the most devastating diagnoses in oncology. Approximately 14,000 Americans are newly diagnosed each year, recurrence is virtually inevitable, and the five-year survival rate remains below 10% - once the disease returns, median survival is typically measured in only a handful of months. These results are extremely exciting and we look forward to continuing to treat patients in our recurrent glioblastoma trial, pending FDA confirmation following review of our safety report, and to expanding this work into further indications in brain cancer and other high-mortality settings where patients urgently need new approaches.” Dr. Joshua Palmer, Principal Investigator and Radiation Oncologist at the OSUCCC – James, commented: “Recurrent glioblastoma represents one of the most challenging patient populations we treat; often those who have already exhausted surgery, chemoradiation, and perhaps even re-irradiation. A 2023 meta-analysis of treatments available for recurrent GBM found objective response rates ranging from 3.4% for biologic agents and 6.1% for chemotherapies to 26.8% for antiangiogenic therapies, but nothing approaching the responses we’ve seen so far to Alpha DaRT. The physics of alpha emitters address a long-standing problem in CNS radiation oncology: escalating intratumoral dose without injuring sensitive and critical brain tissue. Hopefully seeing that translate into durable responses in our first patients is an important early signal, and I look forward to sharing further details about the patient journey with Alpha DaRT on the conference call later this morning. Watching these first several patients journey through therapy, and seeing their excellent responses and ability to get back to their lives so quickly, marks a critical moment in CNS oncology, in that we may have helped unlock a novel treatment for highly resistant brain tumors.” Dr. J. Bradley Elder, Director of Neurosurgical Oncology at the OSUCCC - James, added: “Recurrent glioblastoma sits at the limits of what conventional neurosurgery can offer. By the time these patients return to us with progressive disease, repeat resection often carries unacceptable risk. Tumors recur in sensitive areas of the brain, surgical scar tissue complicates safe re-entry, and each subsequent operation adds to the cumulative neurological burden a patient can tolerate. These results show that Alpha DaRT may give us a way to intervene precisely at that point. Because source placement leverages the same stereotactic navigation we use every day for brain biopsy, we can deliver this novel therapy within an established minimally invasive workflow rather than committing the patient to another more invasive procedure. Our initial patients have tolerated the procedure well, and seeing tumors we could no longer surgically address respond on follow-up imaging is exactly the outcome this approach was designed to enable.” Dr. Robert Den, Chief Medical Officer of Alpha Tau, added: "It is immensely gratifying to see these interim results of our recurrent glioblastoma protocol. In a disease where median survival after recurrence is typically under 12 months and where promising approaches have repeatedly failed to translate to successful outcomes, this profile of activity and tolerability gives us strong rationale to advance the trial toward full accrual." Conference Call on Monday, May 11, 2026 at 8:30am ET Alpha Tau will host a conference call with management, together with Dr. Joshua Palmer on May 11, 2026, at 8:30 am ET. To access the call, please register at https://alpha-tau-interim-results-conference-call.open-exchange.net/. An archived webcast will be available following the event. About the REGAIN Study The REGAIN study is a prospective, open-label, single arm interventional study designed to evaluate the feasibility and safety of Alpha DaRT for the potential treatment of recurrent glioblastoma. The clinical trial is expected to enroll up to ten U.S. patients with recurrent GBM not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment, following the Company’s promising results from pre-clinical studies. Additional information about the trial can be found at https://www.clinicaltrials.gov/study/NCT06910306 About Alpha Tau Medical Ltd. Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University. About Alpha DaRT® Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking statements. The Alpha DaRT treatment has not been approved in the US for commercialization or for use outside of an approved clinical trial. In addition, any statements or information that refer to the Alpha DaRT treatment in GBM patients, including the expected patient enrollment, benefits, safety, implementation, feasibility and go to market process, and other expectations, beliefs, plans, including with respect to clinical trials, regulatory approvals and studies, are forward-looking. All forward-looking statements are based upon Alpha Tau’s current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau’s ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau’s limited operating history; (iii) Alpha Tau’s incurrence of significant losses to date; (iv) Alpha Tau’s need for additional funding and ability to raise capital when needed; (v) Alpha Tau’s limited experience in medical device discovery and development; (vi) Alpha Tau’s dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau’s clinical studies to predict final study results; (viii) failure of Alpha Tau’s early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau’s ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau’s Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau’s exposure to patent infringement lawsuits; (xii) Alpha Tau’s ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq’s listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption “Risk Factors” in Alpha Tau’s annual report filed on form 20-F with the SEC on March 9, 2026, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau’s views as of any date subsequent to the date of this press release. CONTACT: Investor Relations Contact: [email protected]
Investor releaseQuarter not tagged2026-05-08Alpha Tau to Host Conference Call to Discuss Interim Results from First Three Patients Treated for Recurrent Glioblastoma
GlobeNewswire
Alpha Tau to Host Conference Call to Discuss Interim Results from First Three Patients Treated for Recurrent Glioblastoma
JERUSALEM, May 08, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT® today announced that it will host a conference call and webcast on Monday, May 11, 2026 at 8:30am ET to discuss interim clinical data from the first three patients treated in its U.S. trial of Alpha DaRT for patients with recurrent glioblastoma (GBM), also known as the REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial. Conference Call and Webcast Details Date: Monday, May 11, 2026 Time: 8:30am ET Web Access: https://alpha-tau-interim-results-conference-call.open-exchange.net/ An archived webcast will be available following the event. About the REGAIN Study The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment, following the Company’s promising results from pre-clinical studies. Additional information about the trial can be found at https://www.clinicaltrials.gov/study/NCT06910306 About Alpha Tau Medical Ltd. Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University. About Alpha DaRT® Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “will,” “plan,” “may,” “continue,” and similar expressions are inte…Read full documentShow less
JERUSALEM, May 08, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT® today announced that it will host a conference call and webcast on Monday, May 11, 2026 at 8:30am ET to discuss interim clinical data from the first three patients treated in its U.S. trial of Alpha DaRT for patients with recurrent glioblastoma (GBM), also known as the REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial. Conference Call and Webcast Details Date: Monday, May 11, 2026 Time: 8:30am ET Web Access: https://alpha-tau-interim-results-conference-call.open-exchange.net/ An archived webcast will be available following the event. About the REGAIN Study The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment, following the Company’s promising results from pre-clinical studies. Additional information about the trial can be found at https://www.clinicaltrials.gov/study/NCT06910306 About Alpha Tau Medical Ltd. Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University. About Alpha DaRT® Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to the Alpha DaRT treatment in GBM patients, including the expected patient enrollment, benefits, safety, implementation, feasibility and go to market process, and other expectations, beliefs, plans, including with respect to clinical trials, including the REGAIN study,, regulatory approvals and studies, are forward-looking. All forward-looking statements are based upon Alpha Tau’s current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau’s ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau’s limited operating history; (iii) Alpha Tau’s incurrence of significant losses to date; (iv) Alpha Tau’s need for additional funding and ability to raise capital when needed; (v) Alpha Tau’s limited experience in medical device discovery and development; (vi) Alpha Tau’s dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau’s clinical studies to predict final study results; (viii) failure of Alpha Tau’s early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau’s ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau’s Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau’s exposure to patent infringement lawsuits; (xii) Alpha Tau’s ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq’s listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption “Risk Factors” in Alpha Tau’s annual report filed on form 20-F with the SEC on March 9, 2026, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau’s views as of any date subsequent to the date of this press release. Investor Relations Contact: [email protected]
Investor releaseQuarter not tagged2026-05-05Alpha Tau Announces Upcoming Podium Presentation at the AHNS 12th International Conference on Head and Neck Cancer Showcasing Study Results of Alpha DaRT® Head and Neck Cancer Combination with Pembrolizumab
GlobeNewswire
Alpha Tau Announces Upcoming Podium Presentation at the AHNS 12th International Conference on Head and Neck Cancer Showcasing Study Results of Alpha DaRT® Head and Neck Cancer Combination with Pembrolizumab
- Abstract from trial evaluating Alpha DaRT® in combination with pembrolizumab in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma selected for podium presentation - - The AHNS International Conference on Head and Neck Cancer is widely recognized as one of the premier global forums dedicated to advancing head and neck oncology - - Clinical trial builds on Alpha DaRT monotherapy data generated across clinical studies in the United States, Europe, Israel, and Japan, and marks a key milestone in the Company’s combination therapy strategy - - Head and neck cancer is the sixth most common malignancy worldwide, with elderly patients facing particularly limited treatment options and poor outcomes - JERUSALEM, May 05, 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 that an abstract entitled “Management of Locally Advanced and Metastatic Head and Neck Squamous Cell Carcinoma in Elderly Patients Using Diffusing Alpha-Emitter Radiation Therapy in Combination with Pembrolizumab” has been accepted for podium presentation at the American Head and Neck Society (“AHNS”) 12th International Conference on Head and Neck Cancer, taking place July 18-22, 2026, in Boston, Massachusetts. The presentation is scheduled to occur during the Proffered Papers session on Radiation and Adjuvant Therapies on Tuesday, July 21, 2026, 10:30 AM - 12:00 PM. The AHNS International Conference on Head and Neck Cancer is one of the world’s premier forums dedicated to advancing multidisciplinary head and neck oncology, bringing together leading surgeons, oncologists, and researchers from across the globe. Selection for a podium presentation represents one of the highest distinctions at the conference, reserved for abstracts of particular scientific merit and clinical significance. Head and neck squamous cell carcinoma (HNSCC) is the sixth most common malignancy worldwide, with approximately 25-40% of patients diagnosed at age 70 or older. Elderly patients with locally advanced or metastatic disease face a particularly significant unmet medical need, as they are often ineligible for or unable to tolerate aggressive multimodal therapies, and available treatment options for this vulnerable population are associated with suboptimal sur…Read full documentShow less
- Abstract from trial evaluating Alpha DaRT® in combination with pembrolizumab in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma selected for podium presentation - - The AHNS International Conference on Head and Neck Cancer is widely recognized as one of the premier global forums dedicated to advancing head and neck oncology - - Clinical trial builds on Alpha DaRT monotherapy data generated across clinical studies in the United States, Europe, Israel, and Japan, and marks a key milestone in the Company’s combination therapy strategy - - Head and neck cancer is the sixth most common malignancy worldwide, with elderly patients facing particularly limited treatment options and poor outcomes - JERUSALEM, May 05, 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 that an abstract entitled “Management of Locally Advanced and Metastatic Head and Neck Squamous Cell Carcinoma in Elderly Patients Using Diffusing Alpha-Emitter Radiation Therapy in Combination with Pembrolizumab” has been accepted for podium presentation at the American Head and Neck Society (“AHNS”) 12th International Conference on Head and Neck Cancer, taking place July 18-22, 2026, in Boston, Massachusetts. The presentation is scheduled to occur during the Proffered Papers session on Radiation and Adjuvant Therapies on Tuesday, July 21, 2026, 10:30 AM - 12:00 PM. The AHNS International Conference on Head and Neck Cancer is one of the world’s premier forums dedicated to advancing multidisciplinary head and neck oncology, bringing together leading surgeons, oncologists, and researchers from across the globe. Selection for a podium presentation represents one of the highest distinctions at the conference, reserved for abstracts of particular scientific merit and clinical significance. Head and neck squamous cell carcinoma (HNSCC) is the sixth most common malignancy worldwide, with approximately 25-40% of patients diagnosed at age 70 or older. Elderly patients with locally advanced or metastatic disease face a particularly significant unmet medical need, as they are often ineligible for or unable to tolerate aggressive multimodal therapies, and available treatment options for this vulnerable population are associated with suboptimal survival outcomes. While the emergence of immune checkpoint inhibitors has expanded the therapeutic landscape for HNSCC, there remains a compelling rationale for combining localized intratumoral treatments with systemic immunotherapy to potentially enhance immune activation and improve clinical outcomes, particularly in patients for whom conventional approaches carry unacceptable toxicity. The accepted abstract presents complete top-line data from a clinical study conducted at Hadassah Medical Center in Jerusalem, Israel, evaluating Alpha DaRT in combination with pembrolizumab in elderly patients with locally advanced and metastatic HNSCC, from which interim data had previously been presented at the Company’s R&D Day in January 2025. This study represents a natural evolution of Alpha Tau’s head and neck cancer program, building on a foundation of strong monotherapy data generated across clinical studies in the United States, Europe, Israel, and Japan. Preclinical research has strongly suggested that Alpha DaRT treatment may activate an immune response, providing a scientific rationale for combining it with checkpoint immunotherapy. In this combination approach, Alpha DaRT is designed to act as a localized intratumoral add-on to the patient’s standard-of-care immunotherapy regimen, without altering or interrupting the ongoing systemic treatment. Uzi Sofer, CEO of Alpha Tau, stated, “The selection of our combination therapy abstract for a podium presentation at the AHNS International Conference is a strategic milestone for Alpha Tau. Our head and neck cancer program has matured significantly over recent years, with monotherapy studies across the United States, Europe, Israel, and Japan consistently demonstrating the strong safety profile of Alpha DaRT. Moving into combination with immunotherapy is a natural and deliberate next step in our strategy. Head and neck cancer remains a devastating disease with a profound burden on patients and their families, particularly for elderly patients who have limited treatment options and face poor prognoses. We believe the combination of a targeted intratumoral radiotherapeutic approach with systemic immunotherapy represents a highly promising frontier, and we are committed to advancing Alpha DaRT toward becoming a meaningful treatment option for these patients.” Prof. Aron Popovtzer, MD, Director of the Sharett Institute of Oncology at Hadassah Medical Center and the lead Principal Investigator for Alpha DaRT clinical studies at Hadassah, commented, “The patient population in this study - elderly patients with locally advanced or metastatic head and neck squamous cell carcinoma - represents one of the most challenging groups in oncology. These patients often cannot tolerate aggressive chemoradiation, and their treatment options are severely limited. The procedure itself is straightforward, and Alpha DaRT is delivered as an add-on to the patient’s ongoing standard-of-care immunotherapy without requiring any changes to their existing treatment regimen. I look forward to presenting these data at the AHNS conference and to discussing the potential of this combination approach with colleagues from around the world.” Robert B. Den, MD, Chief Medical Officer of Alpha Tau, stated, “This podium presentation at AHNS is an exciting achievement for our combination therapy program. The clinical trial landscape in head and neck cancer is increasingly focused on combining localized and systemic therapies to enhance immune activation, and numerous studies are exploring different intratumoral approaches alongside checkpoint inhibitors. What differentiates Alpha DaRT in this space is its safety profile: Across all of our head and neck cancer studies to date, we have generally observed acute, low-grade toxicities associated with Alpha DaRT, with no chronic effects reported. For patients and physicians alike, this is a critical consideration - the ability to add a potent intratumoral treatment without compounding the toxicity burden of existing systemic therapy. We believe this combination approach opens a compelling new pathway for patients who currently have very few options.” About Alpha DaRT® Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal intratumoral treatment of solid tumors. Alpha DaRT sources are inserted directly into the tumor, where they release short-lived therapeutic particles that disperse locally with the goal of destroying the tumor. Since the therapeutic effect is confined to a short distance, Alpha DaRT aims to mainly affect the tumor and to spare the healthy tissue around it. About Alpha Tau Medical Ltd. Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to the Alpha DaRT treatment in head and neck cancer patients, including the potential benefits and associated risks, future applications and uses, the combination with pembrolizumab, and potential indication approvals, are forward-looking. All forward-looking statements are based upon Alpha Tau’s current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau’s ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau’s limited operating history; (iii) Alpha Tau’s incurrence of significant losses to date; (iv) Alpha Tau’s need for additional funding and ability to raise capital when needed; (v) Alpha Tau’s limited experience in medical device discovery and development; (vi) Alpha Tau’s dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau’s clinical studies to predict final study results; (viii) failure of Alpha Tau’s early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau’s ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau’s Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau’s exposure to patent infringement lawsuits; (xii) Alpha Tau’s ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq’s listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption “Risk Factors” in Alpha Tau’s annual report filed on form 20-F with the SEC on March 9, 2026, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau’s views as of any date subsequent to the date of this press release. Investor Relations Contact: [email protected]
Investor releaseQuarter not tagged2026-04-27Alpha Tau Announces Presentation of Pancreatic Cancer Data at Upcoming ASCO Annual Meeting, Showcasing Combined Results from Three Alpha DaRT Pancreatic Cancer Studies
GlobeNewswire
Alpha Tau Announces Presentation of Pancreatic Cancer Data at Upcoming ASCO Annual Meeting, Showcasing Combined Results from Three Alpha DaRT Pancreatic Cancer Studies
- Abstract accepted at the American Society of Clinical Oncology (ASCO) Annual Meeting - the world’s largest and most prestigious medical oncology conference - - Pooled analysis combines safety and efficacy data from 58 patients across three prospective clinical studies conducted at centers in Canada and Israel - - Acceptance of abstract comes in the same year as presentations at the ASCO Gastrointestinal Cancers Symposium and at Digestive Disease Week (DDW), reflecting growing interest within the expert scientific community in Alpha DaRT pancreatic cancer clinical data - - Abstract to be published on ASCO conference website on May 21, 2026, at 5:00 PM ET - JERUSALEM, April 27, 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 that an abstract entitled “Combined Safety and Efficacy Results from Three Clinical Studies Evaluating Alpha Radiotherapy for Advanced Pancreatic Cancer” has been accepted at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 - June 2, 2026. The abstract is expected to be published on May 21, 2026, at 5:00 PM ET on the ASCO conference website at https://www.asco.org/annual-meeting. The ASCO Annual Meeting is widely regarded as the largest and most prestigious medical oncology conference in the world, attracting tens of thousands of leading oncologists, researchers, and healthcare professionals from across the globe. Abstract acceptance at ASCO is determined through a rigorous, peer-review process and represents recognition of the scientific merit and clinical relevance of the submitted research. The abstract presents a pooled analysis of safety and efficacy data from three prospective clinical studies evaluating endoscopic ultrasound (EUS)-guided intratumoral Alpha DaRT treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). The studies were conducted at the Jewish General Hospital and Centre Hospitalier de l'Université de Montréal (CHUM) in Montreal, Canada, and at the Hadassah Medical Center in Jerusalem, Israel, enrolling a combined total of 58 patients. Acceptance of the abstract at the ASCO Annual Meeting, together with abstract presentation at ASCO GI and Digestive Disease Week (DDW) this year, underscores the growing scient…Read full documentShow less
- Abstract accepted at the American Society of Clinical Oncology (ASCO) Annual Meeting - the world’s largest and most prestigious medical oncology conference - - Pooled analysis combines safety and efficacy data from 58 patients across three prospective clinical studies conducted at centers in Canada and Israel - - Acceptance of abstract comes in the same year as presentations at the ASCO Gastrointestinal Cancers Symposium and at Digestive Disease Week (DDW), reflecting growing interest within the expert scientific community in Alpha DaRT pancreatic cancer clinical data - - Abstract to be published on ASCO conference website on May 21, 2026, at 5:00 PM ET - JERUSALEM, April 27, 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 that an abstract entitled “Combined Safety and Efficacy Results from Three Clinical Studies Evaluating Alpha Radiotherapy for Advanced Pancreatic Cancer” has been accepted at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 - June 2, 2026. The abstract is expected to be published on May 21, 2026, at 5:00 PM ET on the ASCO conference website at https://www.asco.org/annual-meeting. The ASCO Annual Meeting is widely regarded as the largest and most prestigious medical oncology conference in the world, attracting tens of thousands of leading oncologists, researchers, and healthcare professionals from across the globe. Abstract acceptance at ASCO is determined through a rigorous, peer-review process and represents recognition of the scientific merit and clinical relevance of the submitted research. The abstract presents a pooled analysis of safety and efficacy data from three prospective clinical studies evaluating endoscopic ultrasound (EUS)-guided intratumoral Alpha DaRT treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). The studies were conducted at the Jewish General Hospital and Centre Hospitalier de l'Université de Montréal (CHUM) in Montreal, Canada, and at the Hadassah Medical Center in Jerusalem, Israel, enrolling a combined total of 58 patients. Acceptance of the abstract at the ASCO Annual Meeting, together with abstract presentation at ASCO GI and Digestive Disease Week (DDW) this year, underscores the growing scientific interest and momentum behind the Alpha DaRT pancreatic cancer program. Uzi Sofer, CEO of Alpha Tau, stated, “The acceptance of an abstract at the ASCO Annual Meeting is a wonderful milestone for Alpha Tau and a powerful endorsement of our pancreatic cancer strategy by some of the most prestigious leaders in the field. The continued recognition of our clinical program reflects the growing maturity and strength of our evidence base, and validates the strategic vision behind our multi-study approach to pancreatic cancer: to build one of the most comprehensive intratumoral radiotherapeutic clinical programs in pancreatic cancer worldwide.” Corey Miller, MD, MSc, Director of Therapeutic Endoscopy of the Division of Gastroenterology at the Jewish General Hospital, Assistant Professor of Medicine at McGill University, and the first and presenting author of the abstract, commented, “As the first physician to deliver Alpha DaRT into the pancreas using an endoscopic ultrasound-guided approach, it is deeply meaningful to see how far this program has come. What began as a first-in-human feasibility procedure has evolved into a robust clinical data set, made possible by the close collaboration between gastroenterology, medical oncology and radiation oncology teams. It is this combined effort that enabled the accrual of this cohort and the generation of comprehensive results now accepted at the world’s foremost oncology conference. The EUS-guided intratumoral approach has proven to be technically feasible and well-integrated into clinical workflows, and we look forward to sharing these findings with the global medical community when the abstract is published by ASCO and in the Journal of Clinical Oncology.” Robert B. Den, MD, Chief Medical Officer of Alpha Tau stated, “This ASCO acceptance is a significant validation of our growing pancreatic cancer clinical program at a critical time. The pooled analysis provides a strong foundation of clinical evidence, and we are actively building on this momentum. Our flagship multicenter IMPACT trial in the United States continues to advance, evaluating Alpha DaRT in combination with chemotherapy in patients with newly diagnosed unresectable pancreatic cancer. In addition, we recently treated the first patient in April in the ACAPELLA trial - a multicenter study in France evaluating Alpha DaRT alongside capecitabine in patients with locally advanced pancreatic cancer. Together, these studies represent an expanding and increasingly global clinical pipeline dedicated to addressing one of the most significant unmet needs in oncology.” About Alpha DaRT® Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal intratumoral treatment of solid tumors. Alpha DaRT sources are inserted directly into the tumor, where they release short-lived therapeutic particles that disperse locally with the goal of destroying the tumor. Since the therapeutic effect is confined to a short distance, Alpha DaRT aims to mainly affect the tumor and to spare the healthy tissue around it. About Alpha Tau Medical Ltd. Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University. 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 pancreatic patients, including the potential benefits and associated risks, future applications and uses, the IMPACT study, the ACAPELLA study, timing of the abstract publication, and potential indication approvals, are forward-looking. All forward-looking statements are based upon Alpha Tau’s current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau’s ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau’s limited operating history; (iii) Alpha Tau’s incurrence of significant losses to date; (iv) Alpha Tau’s need for additional funding and ability to raise capital when needed; (v) Alpha Tau’s limited experience in medical device discovery and development; (vi) Alpha Tau’s dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau’s clinical studies to predict final study results; (viii) failure of Alpha Tau’s early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau’s ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau’s Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau’s exposure to patent infringement lawsuits; (xii) Alpha Tau’s ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq’s listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption “Risk Factors” in Alpha Tau’s annual report filed on form 20-F with the SEC on March 9, 2026, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau’s views as of any date subsequent to the date of this press release. Investor Relations Contact: [email protected]
Investor releaseQuarter not tagged2026-03-10Alpha Tau Announces Full Year 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Alpha Tau Announces Full Year 2025 Financial Results and Provides Corporate Update
- Tremendous activity in recent months, including receipt of Japanese marketing approval, the fifth parallel U.S. trial approval, data from pancreatic cancer trials presented at ASCO GI Symposium, and the first brain cancer treatment - - Multiple meaningful milestones targeted in the coming months, including completion of patient recruitment in the U.S. pivotal ReSTART skin cancer trial, in the U.S. pilot IMPACT pancreatic cancer trial, and in the U.S. recurrent glioblastoma multiforme feasibility trial - - $76.9 million in cash, cash equivalents & deposits provides continued balance sheet strength for clinical advancement and commercial preparation - JERUSALEM, March 09, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, reported full year 2025 financial results and provided a corporate update. "The pace of progress at Alpha Tau today is unlike anything we’ve ever seen before," said Alpha Tau Chief Executive Officer Uzi Sofer. “With a slew of meaningful announcements in the past few months, culminating most recently with our receipt of marketing approval in Japan, our first outside of Israel, and with multiple meaningful milestones targeted for the coming months, we remain laser focused on execution. Clinical trial progress remains our highest priority, with an astounding five clinical trials approved in parallel in the U.S. At the same time, we continue to build out our manufacturing capabilities in New Hampshire as well as our pre-commercial preparations, while entertaining multiple tracks of strategic dialogue with partners who show increasing excitement about the ever-expanding prospects for Alpha DaRT.” Recent Corporate Highlights: Commercial-Scale U.S. Manufacturing Milestone: In October, Alpha Tau announced the receipt of a radioactive material license for its New Hampshire manufacturing facility, its first commercial-scale facility. The license paves the way for the introduction of radioactive material and continued positive momentum toward initiating Alpha DaRT treatment manufacturing onsite in 2026. 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. FDA Approval to Start Prostate Canc…Read full documentShow less
- Tremendous activity in recent months, including receipt of Japanese marketing approval, the fifth parallel U.S. trial approval, data from pancreatic cancer trials presented at ASCO GI Symposium, and the first brain cancer treatment - - Multiple meaningful milestones targeted in the coming months, including completion of patient recruitment in the U.S. pivotal ReSTART skin cancer trial, in the U.S. pilot IMPACT pancreatic cancer trial, and in the U.S. recurrent glioblastoma multiforme feasibility trial - - $76.9 million in cash, cash equivalents & deposits provides continued balance sheet strength for clinical advancement and commercial preparation - JERUSALEM, March 09, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, reported full year 2025 financial results and provided a corporate update. "The pace of progress at Alpha Tau today is unlike anything we’ve ever seen before," said Alpha Tau Chief Executive Officer Uzi Sofer. “With a slew of meaningful announcements in the past few months, culminating most recently with our receipt of marketing approval in Japan, our first outside of Israel, and with multiple meaningful milestones targeted for the coming months, we remain laser focused on execution. Clinical trial progress remains our highest priority, with an astounding five clinical trials approved in parallel in the U.S. At the same time, we continue to build out our manufacturing capabilities in New Hampshire as well as our pre-commercial preparations, while entertaining multiple tracks of strategic dialogue with partners who show increasing excitement about the ever-expanding prospects for Alpha DaRT.” Recent Corporate Highlights: Commercial-Scale U.S. Manufacturing Milestone: In October, Alpha Tau announced the receipt of a radioactive material license for its New Hampshire manufacturing facility, its first commercial-scale facility. The license paves the way for the introduction of radioactive material and continued positive momentum toward initiating Alpha DaRT treatment manufacturing onsite in 2026. 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. FDA Approval to Start Prostate Cancer Trial: In December, Alpha Tau announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with locally recurrent prostate cancer using the Company’s Alpha DaRT technology. According to the National Cancer Institute, over 300,000 new cases of prostate cancer were expected to be diagnosed in 2025, and clinical literature indicates that up to 15% of patients treated with external beam radiation therapy can develop local recurrence within 15 years of treatment. The clinical trial is expected to enroll up to 12 U.S. patients with locally recurrent prostate cancer who have demonstrated biochemical recurrence by the Phoenix definition (a rise of PSA levels by 2 ng/mL from the PSA nadir). For more information, please see here: https://clinicaltrials.gov/study/NCT07290998 First Patient Treated in U.S. Brain Cancer Trial: In December, Alpha Tau treated its first patient in its pilot study for the treatment of patients with recurrent glioblastoma multiforme (GBM) using the Alpha DaRT technology. According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months, and 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. For more information, please see here: https://clinicaltrials.gov/study/NCT06910306 First Module Submitted to FDA as Part of Application for Marketing Authorization in Skin Cancer: In January, the Company announced the submission of the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA), following the FDA’s previous decision to allow the Company to use the more flexible modular approach. The Company submitted the module with respect to non-clinical studies as part of an application for the use of Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer, for patients not indicated for surgery or standard radiation therapy, and for whom no curative systemic treatment is available. New Positive Data in Pancreatic Cancer Presented at ASCO: In January, investigators from the Company’s first-in-human pancreatic cancer study in Montreal, Canada exploring the use of Alpha DaRT in treating pancreatic ductal adenocarcinoma (PDAC) were awarded two separate presentations at the 2026 ASCO Gastrointestinal Cancers Symposium showcasing results from the trial. The results demonstrated a 22% objective response rate (ORR) and an 81% disease control rate (DCR) across all 32 patients treated in the study, or 23% ORR and 87% DCR when excluding the first two patients, who were deliberately given low dosages in order to examine feasibility and safety only. In addition, investigators presented results showing the immune-preserving profile of Alpha DaRT in PDAC, based on immune markers as well as inflammatory indices known to be negative prognostic indicators, and which typically worsen after other forms of radiation therapy. Received Marketing Approval in Japan for Head and Neck Cancer: In February, Alpha Tau announced the receipt of Japanese marketing approval for Alpha DaRT in unresectable locally advanced or locally recurrent head and neck cancer, marking the first regulatory approval of the Alpha DaRT platform outside Israel. As part of the approval, Alpha Tau will need to conduct a post-market surveillance (PMS) study enrolling 66 patients in total at five selected leading clinical centers in Japan, and the Company’s immediate focus is on working closely with Japanese clinicians to complete the PMS study and to generate high-quality clinical data in patients with unresectable locally advanced or locally recurrent disease. Expected Upcoming Milestone Targets: Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma at the end of Q1 2026. For more information, please see here: https://www.clinicaltrials.gov/study/NCT05323253 Completion of patient recruitment in pancreatic cancer pilot study in the U.S. in Q2 2026. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06698458 Initial safety readout from the first three patients in the recurrent GBM trial in Q2 2026, and completion of patient recruitment in the second half of 2026. For more information, please see here: https://clinicaltrials.gov/study/NCT06910306 Financial results for year ended December 31, 2025 R&D expenses for the year ended December 31, 2025 were $32.1 million, compared to $27.0 million for the same period in 2024, due to increased employee compensation and benefits, increased costs of raw materials, and increased third-party contractor expenses (including clinical trial sites). Marketing expenses for the year ended December 31, 2025 were $1.9 million, compared to $2.3 million for the same period in 2024, due to decreased compensation expenses and travel abroad. G&A expenses for the year ended December 31, 2025 were $8.4 million, compared to $6.7 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation, and increased professional fees (including legal and IR expenses). Financial expense, net, for the year ended December 31, 2025 was $0.2 million, compared to $4.3 million financial income, net, for the same period in 2024, due to a decrease in income from remeasurement of warrants and in interest from bank deposits as well as increased expense from changes in foreign exchange rates. For the year ended December 31, 2025, the Company had a net loss of $42.6 million, or $0.53 per share, compared to a net loss of $31.8 million, or $0.45 per share, in the year ending December 31, 2024. Balance Sheet Highlights As of December 31, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $76.9 million, compared to $62.9 million at December 31, 2024. Annual Report Availability Alpha Tau’s Annual Report on Form 20-F for the fiscal year ended December 31, 2025, has been filed today with the Securities and Exchange Commission. The Annual Report on Form 20-F can be accessed on the Investor Relations section of Alpha Tau’s website at https://www.alphatau.com and on the SEC’s website at www.sec.gov. 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 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. 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, regulatory approvals and studies, the NH facility and its manufacturing capabilities, study recruitment, the post-market surveillance study, potential partnerships, projections, objectives, performance, , 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. CONTACT: Investor Relations Contact: [email protected]
Investor releaseQuarter not tagged2026-01-06Alpha Tau Reports New Positive Results in Two Upcoming Presentations at ASCO GI 2026 Symposium Showcasing Immune-Preservation and High Disease Control in Montreal Pancreatic Cancer Alpha DaRT® Study
GlobeNewswire
Alpha Tau Reports New Positive Results in Two Upcoming Presentations at ASCO GI 2026 Symposium Showcasing Immune-Preservation and High Disease Control in Montreal Pancreatic Cancer Alpha DaRT® Study
- Final results from first pancreatic cancer study in Montreal demonstrate 81% disease control rate, or 87% excluding the first two patients - - Immune markers demonstrate immune system preservation not typical of conventional radiation therapy treatments, as well as potential anti-inflammatory effect - - Alpha DaRT currently being studied together with first-line chemotherapy in U.S. multi-center pilot trial for newly diagnosed pancreatic cancer - JERUSALEM, Jan. 06, 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 release of final results from its first-in-human pancreatic cancer study in Montreal, Canada exploring the use of Alpha DaRT in treating pancreatic ductal adenocarcinoma (PDAC). The results have been published as two abstracts and will be presented at the upcoming 2026 ASCO Gastrointestinal Cancers Symposium in San Francisco, January 8 – 10, 2026. Study Principal Investigator Corey Miller, MD, MSc, Director of Therapeutic Endoscopy of the Division of Gastroenterology of the JGH, Assistant Professor of Medicine at McGill University, Associate Researcher at the Lady Davis Institute, will lead a presentation entitled “Feasibility, Safety and Efficacy of Endoscopic Ultrasound-Guided Alpha Radiotherapy for Advanced Pancreatic Cancer: A Pilot Study” with final clinical results of the Company’s trial. In the trial, 32 patients with Stage II, III or IV PDAC were treated, many of whom had one or more prior rounds of chemotherapy. The results demonstrate a 22% objective response rate (ORR) and an 81% disease control rate (DCR) across all 32 patients treated in the study, or 23% ORR and 87% DCR when excluding the first two patients, who were deliberately given low dosages in order to examine feasibility and safety only. The Company is further exploring the use of Alpha DaRT in treating PDAC in 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, as well as in other clinical studies in Europe. Additional information about the IMPACT trial can be found at https://clin…Read full documentShow less
- Final results from first pancreatic cancer study in Montreal demonstrate 81% disease control rate, or 87% excluding the first two patients - - Immune markers demonstrate immune system preservation not typical of conventional radiation therapy treatments, as well as potential anti-inflammatory effect - - Alpha DaRT currently being studied together with first-line chemotherapy in U.S. multi-center pilot trial for newly diagnosed pancreatic cancer - JERUSALEM, Jan. 06, 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 release of final results from its first-in-human pancreatic cancer study in Montreal, Canada exploring the use of Alpha DaRT in treating pancreatic ductal adenocarcinoma (PDAC). The results have been published as two abstracts and will be presented at the upcoming 2026 ASCO Gastrointestinal Cancers Symposium in San Francisco, January 8 – 10, 2026. Study Principal Investigator Corey Miller, MD, MSc, Director of Therapeutic Endoscopy of the Division of Gastroenterology of the JGH, Assistant Professor of Medicine at McGill University, Associate Researcher at the Lady Davis Institute, will lead a presentation entitled “Feasibility, Safety and Efficacy of Endoscopic Ultrasound-Guided Alpha Radiotherapy for Advanced Pancreatic Cancer: A Pilot Study” with final clinical results of the Company’s trial. In the trial, 32 patients with Stage II, III or IV PDAC were treated, many of whom had one or more prior rounds of chemotherapy. The results demonstrate a 22% objective response rate (ORR) and an 81% disease control rate (DCR) across all 32 patients treated in the study, or 23% ORR and 87% DCR when excluding the first two patients, who were deliberately given low dosages in order to examine feasibility and safety only. The Company is further exploring the use of Alpha DaRT in treating PDAC in 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, as well as in other clinical studies in Europe. Additional information about the IMPACT trial can be found at https://clinicaltrials.gov/study/NCT06698458. “We are very excited about the results of the study, in which we were the first clinicians to deliver Alpha DaRT via endoscopic ultrasound into the pancreas,” added Dr. Miller. “The results indicate that Alpha DaRT is a technically feasible treatment of pancreatic cancer, with a strong safety profile and encouraging local disease control. We look forward to further exploration of the use of Alpha DaRT for PDAC patients in the IMPACT trial as well as future trials, with the potential to generate a meaningful data set focused on a specific patient population with newly diagnosed disease.” In addition, in a presentation entitled “Inflammatory and Immune Marker Dynamics following Intratumoral Alpha DaRT for Pancreatic Cancer”, Kim Anh Ma, MD, Assistant Professor of Oncology at Jewish General Hospital in Montreal, will present results showing the immune-preserving profile of Alpha DaRT in PDAC, based on immune markers as well as inflammatory indices known to be negative prognostic indicators, and which typically worsen after other forms of radiation therapy. In a study of 23 PDAC patients treated with Alpha DaRT who had complete laboratory data, one month following Alpha DaRT treatment, investigators observed no significant change in Neutrophil-to-Lymphocyte Ratio, Platelet-to-Lymphocyte Ratio, CD4/CD8 T-cell ratio, or C-Reactive Protein levels, demonstrating immune system preservation not typical of conventional radiation therapy treatments. Moreover, low post-treatment levels of some of these indices were associated with favorable disease control. Furthermore, a dramatic drop in levels of IL-6 cytokine (p<0.000001), a key mediator of inflammation, suggested a potential reduced inflammatory effect. Dr. Ma noted, “It is quite unique to find a radiation therapy with reduced inflammatory profile and no observed increase in negative prognostic factors, typically linked to radiation-induced lymphopenia. This may enable, or even support, other systemic therapies, such as immunotherapy, and may also help explain anecdotes where systemic response to chemotherapy appeared to improve after insertion of Alpha DaRT into the primary tumor in the pancreas.” Uzi Sofer, CEO of Alpha Tau, stated, “Exploring the treatment of pancreatic cancer remains a cornerstone of our strategy for Alpha DaRT, with multiple clinical trials being pursued in parallel, led by our flagship IMPACT trial, which continues to see an excellent pace of recruitment. We look forward to generating further data in this indication in 2026 and forging ahead toward a potential future approval in this key indication.” 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 pancreatic patients, including the potential benefits and associated risks, future applications and uses, the IMPACT study and potential indication approvals , are forward-looking. All forward-looking statements are based upon Alpha Tau’s current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau’s ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau’s limited operating history; (iii) Alpha Tau’s incurrence of significant losses to date; (iv) Alpha Tau’s need for additional funding and ability to raise capital when needed; (v) Alpha Tau’s limited experience in medical device discovery and development; (vi) Alpha Tau’s dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau’s clinical studies to predict final study results; (viii) failure of Alpha Tau’s early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau’s ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau’s Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau’s exposure to patent infringement lawsuits; (xii) Alpha Tau’s ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq’s listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption “Risk Factors” in Alpha Tau’s annual report filed on form 20-F with the SEC on March 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. Investor Relations Contact: [email protected]
Investor releaseQuarter not tagged2025-11-21Alpha Tau Announces Third Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Alpha Tau Announces Third Quarter 2025 Financial Results and Provides Corporate Update
- Alpha DaRT pancreatic cancer patient treatments underway in U.S. multi-center pilot study - - Newly received radioactive material license for New Hampshire facility positions the Company for continued advancement towards commercial readiness - - Multiple meaningful milestones targeted in the coming months, including completion of patient recruitment in the U.S. pivotal ReSTART trial - - Cash, cash equivalents & deposits balance of $75.9 million provides runway for continued clinical advancement and commercial preparation - JERUSALEM, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, reported third quarter 2025 financial results and provided a corporate update. "The third quarter has seen a fantastic continuation of our accelerating momentum at Alpha Tau, as the pace of patient treatments continues to rise, and we draw increased interest from our peers in the industry" said Alpha Tau Chief Executive Officer Uzi Sofer. “Receiving the radioactive license approval in New Hampshire was a significant milestone in our push for operational commercial readiness, and we are continuing to develop that facility for use in treating patients in the U.S., Canada, and elsewhere, having invested almost $2 million into the facility in Q3. We are very happy with the rate of recruitment in our U.S. multi-center pilot study in pancreatic cancer, and look forward to some potential targeted near-term milestones, including a forthcoming response from the PMDA to our request for marketing authorization in Japan in treating recurrent head & neck cancer, and treating our first patients with glioblastoma multiforme (GBM) shortly. With four IDEs currently active for trials in the U.S., we are continuing to explore with the FDA other potential U.S. trial initiations, potentially in prostate cancer or head & neck cancers.” Recent Corporate Highlights: In September, Alpha Tau announced the treatment of the first patient in its U.S. multi-center pancreatic cancer clinical trial. The trial is expected to enroll up to 30 patients with newly diagnosed pancreatic cancer, in two cohorts: 15 patients with locally advanced disease, and 15 patients with metastatic disease. Patients will receive mFOLFIRINOX chemotherapy together with the Alpha DaRT treatment. Up…Read full documentShow less
- Alpha DaRT pancreatic cancer patient treatments underway in U.S. multi-center pilot study - - Newly received radioactive material license for New Hampshire facility positions the Company for continued advancement towards commercial readiness - - Multiple meaningful milestones targeted in the coming months, including completion of patient recruitment in the U.S. pivotal ReSTART trial - - Cash, cash equivalents & deposits balance of $75.9 million provides runway for continued clinical advancement and commercial preparation - JERUSALEM, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, reported third quarter 2025 financial results and provided a corporate update. "The third quarter has seen a fantastic continuation of our accelerating momentum at Alpha Tau, as the pace of patient treatments continues to rise, and we draw increased interest from our peers in the industry" said Alpha Tau Chief Executive Officer Uzi Sofer. “Receiving the radioactive license approval in New Hampshire was a significant milestone in our push for operational commercial readiness, and we are continuing to develop that facility for use in treating patients in the U.S., Canada, and elsewhere, having invested almost $2 million into the facility in Q3. We are very happy with the rate of recruitment in our U.S. multi-center pilot study in pancreatic cancer, and look forward to some potential targeted near-term milestones, including a forthcoming response from the PMDA to our request for marketing authorization in Japan in treating recurrent head & neck cancer, and treating our first patients with glioblastoma multiforme (GBM) shortly. With four IDEs currently active for trials in the U.S., we are continuing to explore with the FDA other potential U.S. trial initiations, potentially in prostate cancer or head & neck cancers.” Recent Corporate Highlights: In September, Alpha Tau announced the treatment of the first patient in its U.S. multi-center pancreatic cancer clinical trial. The trial is expected to enroll up to 30 patients with newly diagnosed pancreatic cancer, in two cohorts: 15 patients with locally advanced disease, and 15 patients with metastatic disease. Patients will receive mFOLFIRINOX chemotherapy together with the Alpha DaRT treatment. Up to 87% of newly diagnosed pancreatic cancer patients are considered inoperable at diagnosis and face a dismal prognosis, with limited benefit from existing therapies, and the 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. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06698458 In October, Alpha Tau announced the receipt of a radioactive material license for its New Hampshire manufacturing facility, its first commercial-scale facility. The license paves the way for the introduction of radioactive material and continued positive momentum toward initiating Alpha DaRT treatment manufacturing onsite in 2026. 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. Expected Upcoming Milestone Targets: First patient treated in U.S. GBM pilot study in Q4 2025. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06910306 Response from Japan's PMDA around year end 2025 to the application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer. Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q1 2026. For more information, please see here: https://www.clinicaltrials.gov/study/NCT05323253 Completion of patient recruitment in pancreatic cancer pilot study in the U.S. by the end of Q1 2026. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06698458 Financial Results for Nine Months Ended September 30, 2025 Research and Development expenses for the nine months ended September 30, 2025 were $22.5 million, compared to $19.5 million for the same period in 2024, primarily due to an increase in employee compensation and benefits, costs of raw materials and third-party contractor expenses, reflecting increased clinical activities, as well as decreased government grants, offset by lower share-based compensation expenses and travel expenses. Marketing expenses for the nine months ended September 30, 2025 were $1.4 million, compared to $1.7 million for the same period in 2024, due to decreased employee compensation and benefits and decreased marketing conference activities and travel expenses. General and Administrative expenses for the nine months ended September 30, 2025 were $5.8 million, compared to $4.6 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation and professional fees (including legal and IR expenses), offset by a decrease in travel expenses and D&O insurance costs. Financial expense, net, for the nine months ended September 30, 2025 was $0.6 million, compared to financial income, net, of $3.5 million for the same period in 2024, primarily due to an increase in the remeasurement of warrants, a decrease in interest from bank deposits, and changes in foreign exchange rates. For the nine months ended September 30, 2025, the Company had a net loss of $30.5 million, or $0.39 per share, compared to a net loss of $22.3 million, or $0.32 per share, in the nine months ended September 30, 2024. Balance Sheet Highlights As of September 30, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $75.9 million, compared to $62.9 million at December 31, 2024. 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 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. 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 expectations, beliefs, plans, including with respect to clinical trials and planned treatments, regulatory approvals and expected responses, studies, the construction of our NH facility and expected production capacity, patient recruitment, projections, objectives, performance, our ability to commercialize, applications with regulatory bodies 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. Investor Relations Contact: [email protected]
Investor releaseQuarter not tagged2025-08-12Alpha Tau Announces Second Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Alpha Tau Announces Second Quarter 2025 Financial Results and Provides Corporate Update
- FDA approval of IDE to conduct a U.S. pilot study exploring the use of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive brain cancer - - Multiple U.S. clinical trials, including pancreatic cancer and GBM pilot studies, positioned for imminent patient treatment initiation during the remainder of 2025 - - Secured $36.9 million through a strategic equity offering at market price from Oramed, while concurrently entering into a strategic IR/PR alliance - - Cash, cash equivalents & deposits balance of $83.3 million provides runway for continued clinical advancement and commercial preparation - JERUSALEM, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, reported second quarter 2025 financial results and provided a corporate update. "The Company's focus activities continue to coalesce, with an increasing emphasis on U.S. clinical trials, priority indications in internal organs, and preparations for commercial scale-up," said Alpha Tau Chief Executive Officer Uzi Sofer. "All four U.S. IDEs are active: Our pivotal skin cancer ReSTART (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy) trial continues to recruit patients actively and is nearing completion; we expect to commence treatment shortly in our trial in immunocompromised patients as well as the pilot IMPACT (Intratumoral Pancreatic Alpha Combination Trial) study; and the GBM study should initiate later in 2025. In parallel we are also deepening our focus on pancreatic cancer, with studies expected to launch shortly in France and Italy. And our push towards commercialization continues: a PMDA response is expected imminently, potentially opening up new commercial opportunities for the Company, and we expect to complete our first phase of construction shortly in our commercial-scale facility in Hudson, New Hampshire, which should be ready to manufacture Alpha DaRT treatments in early 2026." Recent Corporate Highlights: ·In April, Alpha Tau announced receipt of an IDE from the FDA to conduct a U.S. pilot study of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive brain cancer with an estimated average survival rate of only 8 months. The clinical trial is expected to enroll up to ten U.S. pati…Read full documentShow less
- FDA approval of IDE to conduct a U.S. pilot study exploring the use of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive brain cancer - - Multiple U.S. clinical trials, including pancreatic cancer and GBM pilot studies, positioned for imminent patient treatment initiation during the remainder of 2025 - - Secured $36.9 million through a strategic equity offering at market price from Oramed, while concurrently entering into a strategic IR/PR alliance - - Cash, cash equivalents & deposits balance of $83.3 million provides runway for continued clinical advancement and commercial preparation - JERUSALEM, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, reported second quarter 2025 financial results and provided a corporate update. "The Company's focus activities continue to coalesce, with an increasing emphasis on U.S. clinical trials, priority indications in internal organs, and preparations for commercial scale-up," said Alpha Tau Chief Executive Officer Uzi Sofer. "All four U.S. IDEs are active: Our pivotal skin cancer ReSTART (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy) trial continues to recruit patients actively and is nearing completion; we expect to commence treatment shortly in our trial in immunocompromised patients as well as the pilot IMPACT (Intratumoral Pancreatic Alpha Combination Trial) study; and the GBM study should initiate later in 2025. In parallel we are also deepening our focus on pancreatic cancer, with studies expected to launch shortly in France and Italy. And our push towards commercialization continues: a PMDA response is expected imminently, potentially opening up new commercial opportunities for the Company, and we expect to complete our first phase of construction shortly in our commercial-scale facility in Hudson, New Hampshire, which should be ready to manufacture Alpha DaRT treatments in early 2026." Recent Corporate Highlights: ·In April, Alpha Tau announced receipt of an IDE from the FDA to conduct a U.S. pilot study of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive brain cancer with an estimated average survival rate of only 8 months. The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation, building on the Breakthrough Device Designation received from the FDA for this indication. In April, Alpha Tau announced the completion of a $36.9 million registered direct financing from, and strategic public marketing alliance with, an affiliate of Oramed Pharmaceuticals, Inc. (Oramed). Oramed CEO, President and Chairman Nadav Kidron has also joined the Alpha Tau Board of Directors, bringing years of public company biotech experience. Expected Upcoming Milestone Targets: First patient enrolled in pancreatic cancer pilot study in the U.S. in Q3 2025. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06698458 First patient treated in U.S. GBM pilot study in H2 2025. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06910306 Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in H2 2025. For more information, please see here: https://www.clinicaltrials.gov/study/NCT05323253 Response from Japan's PMDA in H2 2025 to application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer. First phase of Hudson, NH facility becomes operational in early 2026. Financial Results for Six Months Ended June 30, 2025 Research and Development expenses for the six months ended June 30, 2025 were $14.2 million, compared to $13.3 million for the same period in 2024, primarily due to an increase in employee compensation and benefits and third-party contractor expenses, reflecting increased clinical activities, as well as decreased government grants, offset by lower costs of raw materials, share-based compensation expenses and travel expenses. Marketing expenses for the six months ended June 30, 2025 were $0.9 million, compared to $1.1 million for the same period in 2024, due to decreased employee compensation and benefits and decreased marketing conference activities. General and Administrative expenses for the six months ended June 30, 2025 were $3.9 million, compared to $3.0 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation and professional fees (including legal, financing and IR expenses), offset by a decrease in travel expenses and D&O insurance costs. Financial income, net, for the six months ended June 30, 2025 was $0.3 million, compared to $2.1 million for the same period in 2024, primarily due to a decrease in interest from bank deposits, and changes in foreign exchange rates. For the six months ended June 30, 2025, the Company had a net loss of $18.8 million, or $0.25 per share, compared to a net loss of $15.4 million, or $0.22 per share, in the six months ended June 30, 2024. Balance Sheet Highlights As of June 30, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $83.3 million, compared to $62.9 million at December 31, 2024. 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 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. 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, regulatory approvals and studies, the construction of our NH facility, projections, objectives, performance, our ability to commercialize, applications with regulatory bodies 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. Investor Relations Contact: [email protected]

