On August 10, 2026 Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), a clinical-stage biotechnology company developing small-molecule therapeutics targeting epigenetic and metabolic drivers of cancer, reported the peer-reviewed publication of preclinical data of Telomir-Zn suppressing tumor growth in prostate and triple-negative breast cancer (TNBC) models through selective modulation of intracellular iron and copper.

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The manuscript, titled "Telomir-Zn Modulates Intracellular Iron and Copper to Inhibit JmjC Histone Demethylases and Suppress Tumor Growth in Prostate and Triple-Negative Breast Cancer," has been published in the Journal of Oncology Research and Therapy, Volume 11, Issue 3. These preclinical findings provide the scientific foundation supporting advancement of Telomir-Zn toward the Company’s planned Phase 1/2 clinical trial in TNBC.

Publication Highlights

KDM Inhibition: The Target at the Core

Histone demethylases, or KDMs, specifically the KDM2, KDM5, and KDM6 families, are often overexpressed in aggressive cancers, where they can promote tumorigenesis by either silencing tumor-suppressor genes or activating oncogenic programs, depending on their substrate specificity and cellular context. Telomir-Zn targets these KDM enzymes by depleting the intracellular iron they require for catalytic activity. This study demonstrates that this KDM-targeting approach translates to meaningful anti-cancer activity.

Iron-Dependent Mechanism Proved

The study’s most critical finding was direct proof that Telomir-Zn’s anti-cancer activity depends on iron depletion. When researchers added iron back to treated TNBC cells, the compound’s killing effect was significantly reversed. This iron-rescue result eliminates alternative explanations and demonstrates the mechanism is real and specific, not a general toxin or off-target effect.

Selective Targeting of Cancer Over Normal Cells

Telomir-Zn killed iron-dependent TNBC cancer cells at low concentrations while leaving normal cells unharmed at concentrations more than 50-fold higher. This selectivity window demonstrates the compound preferentially targets cancer cells with elevated iron dependence, a hallmark of aggressive malignancies like TNBC.

Tumor Suppressor Gene Reactivation

In a prostate cancer model, oral Telomir-Zn suppressed tumor growth and reactivated silenced tumor-suppressor genes (STAT1, GSTP1, RASSF1A, CDKN2A, and MASPIN). In TNBC and prostate cancer, both elevated KDM activity and abnormal DNA methylation can silence tumor-suppressor genes through distinct but complementary epigenetic mechanisms. The compound works through an upstream mechanism distinct from approved drugs that target downstream epigenetic machinery.

Anti-Tumor and Anti-Metastatic Activity

In TNBC human xenograft models, Telomir-Zn reduced primary tumor size across several cell lines. In HCC1806 xenografts, the compound also significantly reduced metastatic dissemination, a critical finding, as most TNBC patients die from spread disease, not the primary tumor. In BT-549 xenografts, Telomir-Zn combined with paclitaxel produced significantly greater tumor reduction than either drug alone, a finding that suggests potential for combination therapy approaches in the clinic and positions Telomir-Zn as both a monotherapy and a chemotherapy partner. Notably, MDA-MB-231 xenografts did not respond, indicating heterogeneous sensitivity based on tumor-specific iron-metabolism features. It tells us that in the future we could be able to stratify patients based on personalized iron-handling signatures and potentially enrich for responders in future clinical development.

Why This Matters for Clinical Development

Triple-negative breast cancer remains a significant clinical challenge. Most patients receive chemotherapy as a backbone, with limited options for targeted or precision-based approaches. Current approved therapies and those in development address symptoms of epigenetic dysregulation but do not target the underlying metabolic drivers, specifically, the dysregulated iron homeostasis that fuels overactive KDM enzymes in iron-addicted cancers.

This publication establishes dysregulated KDM-driven epigenetic silencing as a fundamental cancer vulnerability that can be targeted through selective iron modulation. Unlike conventional epigenetic drugs that broadly inhibit methylation-modifying enzymes (DNMT or HDAC inhibitors), Telomir-Zn targets the upstream metabolic dependency, excess intracellular iron, that fuels KDM overactivity. By depleting labile iron and disabling KDM enzymes, the compound disrupts epigenetic silencing at its root, enabling tumor-suppressor reactivation. This mechanistically distinct approach addresses a therapeutic gap in the current TNBC treatment landscape.

The iron-rescue experiments provide the strongest possible proof that this mechanism is real and specific, enabling clinical strategies for patient selection based on iron-metabolism biomarkers. The preclinical anti-metastatic activity in HCC1806 xenografts is particularly noteworthy, as it suggests potential to address both primary tumor control and disseminated disease, a key unmet need in TNBC.

Management Commentary

"In several cancer types, cancer cells silence critical tumor-suppressor genes through abnormal DNA methylation, essentially turning off the cell’s brakes," said Dr. Itzchak Angel, Chief Scientific Advisor of Telomir. "Overactive KDM enzymes also play a role as important drivers of this epigenetic silencing. Current TNBC treatments address downstream consequences of this dysregulation but do not target the KDM-driven mechanism itself. Our data implicates that by reversing the abnormal methylation and by KDM inhibition, Telomir-Zn can reactivate these silenced tumor-suppressor genes, promoting cell killing. We’re seeing tumor suppression and, in some models, reduced metastatic spread. This is a mechanistically different approach to TNBC, and we believe it addresses a fundamental vulnerability that existing therapies don’t. We’re encouraged by the preclinical evidence and eager to test it in patients."

"Triple-negative breast cancer represents one of oncology’s most significant unmet needs," said Erez Aminov, CEO of Telomir. "Most patients with advanced disease have limited treatment options and poor survival outcomes. We’re excited to advance Telomir-Zn into our Phase 1/2 program under our active IND to test whether this approach can meaningfully improve outcomes for TNBC patients."

(Press release, Telomir Pharmaceutical, AUG 10, 2026, View Source [SID1234669922])

On August 10, 2026 NeOnc Technologies (NASDAQ: NTHI) reported one of its most closely watched weeks of 2026, with the clinical-stage CNS oncology company scheduled to unveil topline Phase 2a results for NEO100 on Wednesday, August 12, putting the spotlight squarely on data from the fully enrolled study evaluating intranasal NEO100 in patients with recurrent IDH1-mutant high-grade glioma. For a small-cap biotechnology company, a clinical readout of this significance can become a powerful near-term catalyst, particularly when investors are already positioning around a defined event.

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The company is developing NEO100, its proprietary formulation of purified perillyl alcohol, as an investigational treatment for central nervous system cancers. The upcoming presentation will focus on the topline analysis of an open-label Phase 2a study evaluating intranasal NEO100 in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma.

The August 12 presentation represents a major near-term catalyst, as NeOnc’s management team is expected to discuss efficacy and safety observations from the Phase 2a portion of the study, along with planned regulatory next steps.

Attention has also focused on insider activity and institutional ownership. Recent SEC filings show Chairman, President and CEO Amir Heshmatpour has invested more than $500,000 through open-market purchases, with insider buying approaching $1 million over the past year. Public filings also identify institutions including Bank of America, State Street, Barclays, and BlackRock among shareholders. Combined with previously disclosed financing facilities and multiple anticipated regulatory milestones during 2026, NeOnc remains closely watched within the CNS oncology sector.

The company has already positioned NEO100 within multiple expedited FDA development pathways, including Orphan Drug, Fast Track and Rare Pediatric Disease designations, adding further significance to the forthcoming clinical update if the topline results are supportive.

NeOnc has also expanded internationally after receiving a second Investigational New Drug (IND) authorization from the Department of Health – Abu Dhabi, allowing additional studies evaluating NEO100 for recurrent high-grade gliomas. The authorization complements the company’s previously announced UAE approval for NEO212, further expanding its international clinical footprint.

NEO100 comprises a patented composition of a proprietary synthesis of Perillyl Alcohol (POH) that our research suggests has several beneficial actions for Central Nervous System (CNS)-based disease applications, including:

Regulates neurologic pathways associated with tumor cell growth.
Bypasses the BBB via its small molecular size when delivered intranasally.
Creates a temporary BBB opening when delivered intra-arterially, enabling larger molecule therapeutics to pass.
Acts as an effective therapeutic for brain cancers in high concentrations.
Serves as a solvent for traditional large-molecule therapeutics at low concentrations, allowing them to bypass the BBB.
Can be conjugated with other CNS therapeutics to create compound formulations with higher BBB penetration and greater effect on brain cancer.
Perillyl Alcohol (POH) is a naturally occurring substance found in the essential oils of plants, such as citrus. It is already FDA-approved as a flavoring food agent.

POH has been shown to have antitumor activity against various cancer types including gliomas. POH induces apoptosis in tumor cells without affecting normal cells and can revert tumor cells to a differentiated state.

In the NEO100 Phase 1/2a trial, NEO100 has been shown to potentially positively impact the treatment of Grade IV gliomas. Grade IV gliomas are among the most aggressive and deadly forms of brain cancers, and patients with this form of cancer face a grim prognosis. Only a quarter of newly diagnosed Glioblastoma patients survive for 24 months, and fewer than 10 percent survive more than five years.

Because of its small lipophilic molecular size, NEO100 can permeate the Blood-Brain-Barrier and therefore allow delivery of itself or a combinatorial therapeutic directly to a tumor site.

Since our clinical trial and research has demonstrated that NEO100 potentially permeates across the Blood Brain Barrier (BBB), three forms of delivery can be used to administer NEO100 or any of its conjugates.

Internasal Delivery – NEO100 can be delivered intranasal through the trigeminal pathway to bypass the BBB. This ability allows NEO100 to be used for local targeted delivery to the brain eliminating the issues associated with oral and intravenous delivery methods.

Permeable BBB Delivery – Since NEO100 is a small, lipophilic (fat-soluble) molecule, it can permeate the BBB which primarily targets the restriction of entry for large molecule substances (pathogens, viruses) and water-soluble compounds.

Intra-Arterial Delivery – NEO100 can be delivered intrathecally through a catheter positioned in the arterial pathway which feeds the tumor and is injected into the tumor site where it would be absorbed through the BBB into the tumor.

The upcoming readout should therefore provide a much clearer view of where NEO100 stands clinically and what the next stage of development could look like.

Investor Conference Call Details

Date: Wednesday, August 12, 2026
Time: 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time
Webcast: Live Webcast
Investor Relations: NeOnc Technologies Investor Relations

A replay will be available on the company’s investor relations website shortly after the presentation.

Featured Participants

Amir Heshmatpour — Executive Chairman, President and Chief Executive Officer
Thomas C. Chen, MD, PhD — Founder, Chief Medical Officer and Chief Scientific Officer
Josh Neman, PhD — Chief Clinical Officer
Keithly Garnett — Chief Financial Officer
With topline Phase 2a data now just days away, August 12 is shaping up as one of the most closely watched dates on NeOnc’s 2026 calendar.

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(Press release, Neonc, AUG 10, 2026, View Source [SID1234669921])

On August 10, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on August 7, 2026, regarding its New Drug Application (NDA) for 177Lu-edotreotide (ITM-11), an investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

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The CRL stated that the FDA is unable to approve the NDA in its present form and cited CMC- and third-party commercial facility-related items that must be addressed before the application can be approved.

The FDA did not identify any concerns regarding the clinical or nonclinical data package or safety profile of ITM-11. ITM is reviewing the agency’s feedback and assessing the appropriate next steps with the relevant external parties.

The Company remains confident in the potential of ITM-11 and is reviewing the FDA’s feedback to determine the most appropriate path forward. The Company intends to resubmit to complete the review of the NDA.

"Our confidence in ITM-11’s therapeutic potential has not wavered, and we are committed to working closely with the FDA and our partners to address the items outlined in the CRL," said Dr. Andrew Cavey, chief executive officer of ITM. "Our pivotal COMPETE trial data package stands, and our goal remains unchanged as we work toward bringing ITM-11 to patients living with advanced GEP-NETs."

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is an investigational product and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. It is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.

(Press release, ITM Isotopen Technologien Munchen, AUG 10, 2026, View Source [SID1234669920])

On August 10, 2026 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported financial and operating results for the second quarter ended June 30, 2026.

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"Our commitment to transforming the metastatic breast cancer treatment paradigm remains resolute as we continue to advance palazestrant as a potentially differentiated endocrine therapy across multiple regimens. Importantly, enrollment in our pivotal OPERA-01 Phase 3 trial is complete and we now expect to report top-line data in the first quarter of 2027," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Beyond palazestrant, we made significant progress with OP-3136, our novel KAT6 inhibitor. The initial monotherapy Phase 1 data, presented at ASCO (Free ASCO Whitepaper), demonstrated that OP-3136 was well-tolerated and showed evidence of anti-tumor activity across multiple dose levels and various tumor types. These data, taken together with our first clinical collaboration for OP-3136, established with Bayer to evaluate OP-3136 in combination with darolutamide in metastatic castration-resistant prostate cancer, reinforce our confidence in its potential as a best-in-class, differentiated option for patients with advanced solid tumors."

Bohen continued, "Supported by a strong balance sheet, we are intently focused on execution in the second half of the year as we ramp preparations for our first potential commercial launch of palazestrant as a monotherapy, work to establish palazestrant as a potential combination agent of choice in breast cancer, and continue our transformation into a fully integrated oncology company."

Recent Progress

Completed enrollment in the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in patients with second or third-line estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC).
Presented initial Phase 1 clinical data for OP-3136 as a monotherapy in multiple solid tumor types and a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- MBC at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Announced a clinical trial collaboration and supply agreement with Bayer to evaluate OP-3136 in combination with darolutamide, Bayer’s androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC).
Completed enrollment in the Phase 1b/2 study of palazestrant in combination with atirmociclib in ER+/HER2- MBC.
Advanced enrollment in the pivotal Phase 3 OPERA-02 trial and the Phase 1 study of OP-3136 as a monotherapy and in combination with fulvestrant and palazestrant in ER+/HER2- MBC.
Anticipated Upcoming Events

Initiate enrollment in the Phase 1b/2 study evaluating OP-3136 in combination with darolutamide in mCRPC in collaboration with Bayer in the fourth quarter of 2026.
Report top-line data from the pivotal Phase 3 OPERA-01 trial in the first quarter of 2027.
Second Quarter 2026 Financial Results
Cash, cash equivalents, and marketable securities as of June 30, 2026, were $461.1 million.

Net loss for the quarter ended June 30, 2026 was $63.2 million, as compared to $43.8 million for the quarter ended June 30, 2025. The increase in net loss for the second quarter was related to higher spending on clinical development and research and corporate-related activities related to late-stage clinical trials for palazestrant and the advancement of OP-3136.

GAAP research and development (R&D) expenses were $57.8 million for the quarter ended June 30, 2026, as compared to $43.9 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and increased personnel-related costs to support expanding development activities, including an increase in non-cash stock-based compensation expense of $5.2 million, mainly due to higher grant prices in 2026 and higher headcount. These increases were partially offset by the $10.0 million milestone expense related to the Aurigene agreement that was recognized in the same period in 2025.

Non-GAAP R&D expenses were $48.9 million for the quarter ended June 30, 2026, excluding $8.9 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $40.2 million for the quarter ended June 30, 2025, excluding $3.7 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $9.4 million for the quarter ended June 30, 2026, as compared to $4.0 million for the quarter ended June 30, 2025. The increase in G&A expenses was primarily due to higher corporate-related costs that reflect continued investment in personnel and corporate infrastructure to support our expanding late-stage clinical development activities and anticipated future commercial operations, including an increase in non-cash stock-based compensation expense of $3.0 million, mainly due to higher grant prices in 2026, and an increase in professional fees of $1.8 million.

Non-GAAP G&A expenses were $5.4 million for the quarter ended June 30, 2026, excluding $4.0 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended June 30, 2025, excluding $1.0 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

(Press release, Olema Oncology, AUG 10, 2026, View Source [SID1234669919])

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])