On August 10, 2026 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.
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"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 (Free ASCO Whitepaper) 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: View Source
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 (Free ASCO Whitepaper) 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: View Source
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: View Source
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: View Source
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: View Source
First patient treated in U.S. locally recurrent prostate cancer pilot trial in the second half of 2026. For more information, please see here: View Source
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: View Source
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.
(Press release, Alpha Tau Medical, AUG 10, 2026, View Source [SID1234669918])