On May 18, 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 first quarter 2026 financial results and provided a corporate update.

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"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 (Free ASCO Whitepaper) 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: View Source
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 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 (Free ASCO Whitepaper) Annual Meeting taking place May 29 – June 2, 2026. The abstract is expected to be published on the ASCO (Free ASCO Whitepaper) 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: View Source." target="_blank" title="View Source." rel="nofollow">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
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: View Source
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.

(Press release, Alpha Tau Medical, MAY 18, 2026, View Source [SID1234665847])