On December 9, 2025 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported updated clinical data from the ongoing frontline Acute Myeloid Leukemia (AML) triplet study (CA-4948-104) in a poster presentation at the 67th ASH (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper).

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The AML triplet study is evaluating the addition of emavusertib (ema) to the combination of venetoclax and azacitidine (ven-aza) in AML patients who have achieved complete remission on ven-aza but remain MRD-positive (MRD+), with the goal of enabling patients to achieve uMRD. The first two cohorts in the study evaluate patients who received emavusertib for either 7 or 14 days in a 28-day cycle, in addition to their ven-aza treatment regimen.

In the ASH (Free ASH Whitepaper) abstract, the company reported initial data showing 4 of 8 patients (50%) had achieved uMRD as of July 2, 2025. These data were updated in the poster presented at ASH (Free ASH Whitepaper) with 5 of 8 patients (62.5%) achieving uMRD, with no change in safety profile, as of October 12, 2025.

"These data are very promising and warrant further evaluation of additional triplet (ema/ven/aza) regimens to determine the optimal dose and schedule for safety and efficacy to improve patient outcomes in a difficult to treat population," said James Dentzer, Curis’s Chief Executive Officer.

(Press release, Curis, DEC 9, 2025, View Source [SID1234661310])

On December 9, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the acceptance of an abstract and poster on the Phase II DISCO trial (NCT04438304)1 data exploring 64Cu-SARTATE in patients with known or suspected neuroendocrine tumours (NETs) to the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium 2026 held on the 8-10th January. The abstract is titled "Diagnostic performance of 64Cu-SARTATE compared to 68Ga-DOTATATE in patients with known or suspected neuroendocrine tumors with focus on liver findings".

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The data to be presented builds on some of the previously announced results2 that 64Cu-SARTATE positron emission tomography (PET) / computed tomography (CT) lesion detection was substantially higher than that of the current standard-of-care (SOC), 68Ga-DOTATATE PET/CT. 64Cu-SARTATE was deemed safe and well tolerated. Out of 45 participants enrolled in the trial, only seven (15.6%) trial participants experienced a total of nine 64Cu-SARTATE-related adverse events: eight were Grade 1 and one was Grade 2, with most resolving within 2 days.

The mean number of lesions detected by 64Cu-SARTATE was approximately double that observed with 68Ga-DOTATATE (441 vs. 227 lesions, respectively; averages across readers and both PET/CT timepoints for 64Cu-SARTATE). Overall, a total of 238 discordant lesions (lesions that were only detected by one of the scans, either 64Cu-SARTATE or 68Ga-DOTATATE PET/CT) were identified in 34 subjects with scan pairs across all body regions, representing a large difference between detection abilities of the two agents. Of these discordant lesions, 223 were detected by 64Cu-SARTATE alone and only 15 by 68Ga-DOTATATE alone. Importantly, for the 122 discordant lesions with evaluable standard of truth ([SOT] biopsy and/or follow-up conventional imaging), the difference in sensitivity between the agents was highly significant, favouring 64Cu-SARTATE (the sensitivities of 64Cu-SARTATE vs. 68Ga-DOTATATE were 94.7% [95% CI 65.1, 99.5] and 5.4% [95% CI 0.5, 34.9], respectively; p<0.001). This clearly demonstrates the considerable difference in sensitivity between 64Cu-SARTATE and SOC imaging, based on lesions detected by either of the agents, showing that 64Cu-SARTATE detected significantly more additional true-positive lesions compared to 68Ga-DOTATATE in the same patients.

New data which is being presented at ASCO (Free ASCO Whitepaper) GI shows that the liver had the highest number of lesions detected by both tracers among all organs/regions assessed: 64Cu-SARTATE PET/CT scans showed 352 lesions while 68Ga-DOTATATE PET/CT only showed 180 lesions. The liver is the most common metastatic site for patients with gastroenteropancreatic (GEP)-NETs, and hepatic metastatic burden is clinically important as it is strongly associated with patient outcomes and significantly influences the clinical management of the disease3. Therefore, the enhanced diagnostic performance offered by 64Cu-SARTATE, especially in key organs such as the liver, may allow clinicians to make treatment decisions with a greater degree of accuracy and confidence, with direct impact on patient outcomes. A Phase III study of 64Cu-SARTATE is being planned.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are thrilled to continue generating valuable data, building further evidence of the best-in-class potential of our pipeline of products in development. As we are moving SARTATE towards commercialisation, it highlights our commitment to developing products for cancer indications with high unmet needs.

"Patients with NETs are often misdiagnosed and experience delays in receiving the correct diagnosis, which may lead to the identification of their cancer at later stages4. Visualising NET lesions earlier and more accurately at various stages of disease, especially in a critical organ like the liver, may have a significant impact on patient outcomes as it equips clinicians with crucial information on disease burden, helping to determine an optimal treatment plan.

"There are currently two key approved agents in the NETs PET imaging space, 68Ga-DOTATATE and 64Cu-DOTATATE, and both have substantial limitations when it comes to providing accurate and timely disease identification. These two products utilise the same chelator (i.e. cage), called DOTA, to hold diagnostic radioisotopes, while binding somatostatin receptor 2 (SSTR2), which is highly expressed in NETs. The key difference between the two agents is the isotope used to image patients, gallium-68 or copper-64. As we have seen with 68Ga-DOTATATE in the DISCO trial, its sensitivity was very low among discordant lesions, meaning several lesions would go undetected until they grew larger in size, if at all. This limitation is primarily due to the short half-life of gallium-68 which underpins the requirement for imaging within 1 hour post-administration. We have seen first-hand that once radiopharmaceutical products are administered, they take time to find the lesion whilst also needing to clear from non-target organs, providing greater contrast, known as tumour-to-background ratio5. Having greater contrast is especially important to identify smaller or more difficult to find cancers. This is where the benefits of using copper-64 with its longer half-life play an important role. However, despite using copper-64, 64Cu-DOTATATE has an important disadvantage where the DOTA chelator leaks copper in vivo6. Free copper-64 isotopes then accumulate in the liver, creating substantial background noise on PET scans which renders identification of lesions in the liver challenging. This is a key drawback with important clinical implications, as the presence of liver metastatic lesions is a notable prognostic factor in survival of these NET patients3.

"64Cu-SARTATE offers considerable advantages compared to approved SSRT2-targeted imaging agents, addressing some of their fundamental limitations and potentially providing patients and clinicians a chance to more accurately identify disease. As with all our products, we continue to rely on strong scientific foundations to develop 64Cu-SARTATE, design its clinical trials and progress the agent towards commercialisation. While employing the same SSTR2 targeting molecule as the existing competitors, which have established safety and efficacy, we have circumvented the issue of copper leakage with the sarcophagine (SAR) cage, enabling optimal imaging timepoints. The proprietary SAR Technology, developed through outstanding Australian benchtop science from the Australian National University and the University of Melbourne, is able to securely hold copper, ensuring there is minimal background in the liver. The combination of optimal imaging timepoints, enabled by copper-64, and secure chelating of the isotopes, made possible by the SAR Technology, is what clearly differentiates 64Cu-SARTATE from the competition, with the benefit of earlier and/or more accurate identification of lesions in NETs.

"With the improved diagnostic performance of 64Cu-SARTATE, based on data generated to date, and the potential of improving treatment outcomes of patients with NETs through reliable and accurate disease identification, we are already planning a registrational Phase III trial of 64Cu-SARTATE in NETs, aiming to expedite this unique agent to market."

About DISCO trial
DISCO is a "Diagnostic Imaging Study of 64COpper-SARTATE Using PET on Patients with Known or Suspected Neuroendocrine Tumours". It assessed the performance of Clarity’s SARTATE imaging product as a potential new method to diagnose and manage NETs. The trial aimed to build on earlier clinical experience with 64Cu-SARTATE in patients with NETs, which demonstrated that the diagnostic has excellent imaging characteristics and suggested that 64Cu-SARTATE PET/CT provides comparable or superior lesion detection to 68Ga-DOTATATE PET/CT in all patients, especially in the liver5.

DISCO recruited 45 participants with Gastroenteropancreatic NETs (GEP-NETs) across 4 sites in Australia, comparing the diagnostic performance of 64Cu-SARTATE PET at an average of 4 hours (between 3 and 5 hours) and approximately 20 hours post-administration (same-day and next-day imaging, respectively) to the current SOC, 68Ga-DOTATATE PET. Out of the 45, there were 41 participants with known NETs and 4 cases of suspected NETs. Most subjects had stage 3 or 4 disease.

Participants were required to have undergone a pre-study 68Ga-DOTATATE PET/CT scan within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE as part of their routine clinical care.

About SARTATE
SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express SSTR2, such as NETs. Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu-SARTATE) or copper-67 (67Cu) for therapy (67Cu-SARTATE).

Disclaimer
64Cu-SARTATE is an unregistered product. The safety and efficacy of 64Cu-SARTATE have not been assessed by health authorities such as the US Food and Drug Administration or the Therapeutic Goods Administration. There is no guarantee that this product will become commercially available.

About NETs
NETs, also known as well-differentiated neuroendocrine neoplasms or carcinoids, represent a heterogeneous group of malignant transformations of cells of the diffuse neuroendocrine system7. They most commonly occur in the gastrointestinal tract (48%), lung (25%), and pancreas (9%), but may also originate in other areas, including the breast, prostate, thymus and skin8. NETs can either be benign or malignant, as well as non-functional and functional9. NETs traditionally have been considered uncommon; however, the incidence has been increasing as a worldwide phenomenon10.

Overall, it is estimated that more than 20,000 people in the United States are diagnosed with a NET each year11, and approximately 190,000 people are living with this diagnosis12. Patients with NETs present with subtle clinical symptoms, which can lead to a delay in diagnosis of more than 4 years13. As such, about 30-75% of NETs patients have distant metastases at the time of diagnosis14. A 10-year relative survival rate for patients with metastatic GEP-NETs is 3–36%.

(Press release, Clarity Pharmaceuticals, DEC 9, 2025, View Source [SID1234661309])

On December 9, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Bristol Myers Squibb Company (NYSE: BMY, "BMS") reported the first interim data from a global randomized Phase 2 trial (NCT06449222) evaluating pumitamig (BNT327/BMS986545), an investigational bispecific antibody targeting PD-L1 and VEGF-A, plus chemotherapy in patients with locally advanced/metastatic triple-negative breast cancer ("TNBC") irrespective of PD-L1 expression levels.

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The data showed encouraging anti-tumor responses and a manageable safety profile for pumitamig plus chemotherapy in first-line and second-line treatment setting. The data will be presented at the 2025 San Antonio Breast Cancer Symposium ("SABCS").

"Triple-negative breast cancer is a highly aggressive disease with a poor prognosis and 5-year survival rate of just 15% in advanced stages.1 There remains an urgent need for new treatment options – particularly for patients with PD-L1 low or negative tumors (CPS<10), a subgroup for whom the current standard of care is chemotherapy alone and existing PD-(L)1 inhibitors have historically shown limited benefit," said Peter Schmid, M.D., Ph.D., Lead Investigator and Director of the Breast Cancer Centre at St. Bartholomew’s Hospital, London, UK. "The anti-tumor efficacy observed in this interim analysis is encouraging and supports the ongoing investigation of pumitamig in the Phase 3 ROSETTA BREAST-01 trial."

The trial evaluated pumitamig in two dose levels and in combination with four different chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic TNBC. In Cohort 1, reported in this analysis, patients received pumitamig (15 or 20 mg/kg Q2W) plus nab-paclitaxel until disease progression or unacceptable toxicity. In Cohort 2, patients received the flat-dose equivalent of 20 mg/kg in combination with three different chemotherapy regimens (Arm 1: paclitaxel; Arm 2: gemcitabine + carboplatin; Arm 3: eribulin).

The interim analysis at the October 1, 2025 data cut-off included 74 patients with 1L/2L+ locally advanced/metastatic TNBC who received pumitamig in combination with standard of care chemotherapy. Key data highlights are provided below:

Efficacy:

Among 39 efficacy-evaluable first-line and second-line patients, all in Cohort 1, the confirmed objective response rate ("cORR") was 61.5% (24/39), the unconfirmed objective response rate ("uORR") was 71.8% (28/39) and the disease control rate ("DCR") was 92.3% (36/39).
Efficacy was encouraging across dose levels, PD-L1 expression levels and lines of treatment and higher doses correlated with higher response (dose levels: uORR: 63.2% at 15 mg/kg dose; 80.0% at 20 mg/kg dose; PD-L1 expression levels: uORR: 70.6% in CPS ≥10; 70.6% in CPS <10; lines of treatment: uORR: 76.5% in 1L and 68.2% in 2L).
The progression-free survival ("PFS") rate at 9 months was 59.3%. Median PFS, median duration of response ("DOR") and median overall survival ("OS") were not mature at the time of analysis.
Safety:

Pumitamig plus chemotherapy demonstrated a manageable safety profile in both Cohorts in combination with all four chemotherapy regimens.
Grade ≥3 treatment-related adverse events (TRAEs) were reported in 17/40 (42.54%) and 13/34 (38.2%) patients in Cohorts 1 and 2, respectively, with no pumitamig-related deaths reported.
"We are encouraged by these first locally advanced/metastatic TNBC data from a global patient population that indicate the potential of pumitamig in patients with advanced TNBC irrespective of PD-L1 status," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "The activity we see in TNBC is consistent with findings in other solid tumors and further supports the pan-tumor potential of pumitamig, which we are advancing together with BMS in a broad development program that also includes novel/novel combination regimens."

"These data add to the growing evidence from global pumitamig studies across multiple indications," said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology, Cell Therapy at Bristol Myers Squibb. "The encouraging results are especially meaningful in patients with PD-L1 low or negative tumors (CPS<10), representing the potential of pumitamig to deliver meaningful benefit across PD-L1 expression levels, including patients who historically have had fewer effective treatments."

A global randomized Phase 3 trial, ROSETTA-BREAST-01 (NCT07173751), is evaluating pumitamig plus chemotherapy versus placebo plus chemotherapy in patients with previously untreated locally advanced/metastatic TNBC determined ineligible for PD-(L)1 therapy based on PD-L1 negative disease. Pumitamig is also being studied in more than 20 clinical trials as monotherapy, in combination with chemotherapy, or with other novel treatment modalities in more than 10 solid tumor indications.

About the BNT327-02 Phase 2 clinical trial
The global randomized, open-label Phase 2 clinical trial (BNT327-02; NCT06449222) evaluated pumitamig (BNT327/ BMS986545) in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic TNBC. In Cohort 1, patients received pumitamig Q2W (15 or 20 mg/kg) plus chemotherapy (nab-paclitaxel) until disease progression or unacceptable toxicity. In Cohort 2, patients received the flat dose equivalent of 20 mg/kg in combination with chemotherapy (Arm 1: paclitaxel Q2W; Arm 2: gemcitabine + carboplatin Q3W; Arm 3: eribulin Q3W). The primary endpoints of the trial were objective response rate (ORR) per investigator’s assessment (RECIST 1.1), change in tumor size and early tumor shrinkage, and safety per NCI CTCAE v5.0. Secondary endpoints include duration of response (DoR), disease control rate (DCR), progression free survival (PFS) and overall survival (OS).

About Triple-Negative Breast Cancer
Triple-negative breast cancer (TNBC), which is defined by a lack of hormone receptors (estrogen or progesterone) and HER2 protein, accounts for about 10-15% of all invasive breast cancer cases.1 It is an aggressive type of breast cancer that tends to grow and spread faster and has a worse prognosis compared to other breast cancer types. The addition of PD-(L)1 immune checkpoint inhibitors to chemotherapy for the first-line treatment of TNBC has improved outcomes in patients with high levels of PD-L1 expression (CPS ≥ 10) on the surface of tumor cells, but many patients experience relapse. In addition, for patients with PD-L1 negative TNBC (CPS<10), the current standard of care is chemotherapy alone, as other PD-(L)1 inhibitors have historically demonstrated poor efficacy in this subgroup. The 5-year survival rate for patients with advanced TNBC is only 15%, emphasizing the need for new treatment options.1

About pumitamig (also known as BNT327 or BMS986545)
Pumitamig is a novel investigational bispecific antibody, jointly developed by BioNTech and BMS, combining two complementary, validated mechanisms in oncology into one single molecule. Pumitamig combines PD-L1 checkpoint inhibition aimed at restoring T cells’ ability to recognize and destroy tumor cells with the neutralization of VEGF-A. The blocking of VEGF-A is aimed at reversing the tumor’s immuno-suppressive effect in its microenvironment and cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), with the intention of preventing the tumor from growing and proliferating. Pumitamig may be differentiated via its mechanism of action of targeting PD-L1 on tumor cells to localize anti-VEGF activity within the tumor microenvironment, aiming to enhance therapeutic precision and minimize systemic exposure.

More than 1,400 patients have been treated with pumitamig in clinical trials to date. More than 20 clinical trials are currently ongoing or planned to evaluate pumitamig either as a monotherapy or in combination with other treatment modalities targeting different oncogenic pathways in more than 10 solid tumor indications. Multiple global trials are ongoing or planned to start, including five global clinical trials with registrational potential evaluating pumitamig plus chemotherapy compared to standard of care treatments in first-line small cell lung cancer (ROSETTA LUNG-01; NCT06712355), first-line non-small cell lung cancer (ROSETTA LUNG-02; NCT06712316), first-line triple-negative breast cancer (ROSETTA BREAST-01, NCT07173751), first-line microsatellite stable colorectal cancer (ROSETTA CRC-203; NCT07221357), and first-line gastric cancer (ROSETTA GASTRIC-204, NCT07221149). Additional trials are ongoing exploring novel treatment combinations of pumitamig, including combinations with BioNTech’s proprietary antibody-drug conjugate candidates ("ADCs") or immunomodulator candidates.

(Press release, BioNTech, DEC 9, 2025, View Source [SID1234661308])

On December 9, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported that it has entered into a securities purchase agreement with new and existing healthcare focused investors and certain insiders of the Company to sell an aggregate of 2,623,023 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 2,623,023 shares of common stock, in a private placement priced at-the-market under Nasdaq rules (the "Offering"). The combined effective offering price for each share of common stock (or pre-funded warrant in-lieu thereof) and accompanying warrant to be issued is $1.165. The warrants to be issued will have an exercise price of $1.04 per share, will be exercisable immediately upon issuance, and will expire on the five-year anniversary of the earlier of the effectiveness date of the registration statement covering the resale of the securities purchased in the Offering and the date the shares underlying the warrants are eligible for resale under Rule 144.

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The gross proceeds to the Company from the Offering are estimated to be approximately $3.1 million before deducting the placement agent’s fees and other estimated Offering expenses. The Company intends to use the upfront net proceeds from the private placement for general corporate purposes and for research and development expenses. The Company believes the aggregate net proceeds from the Offering will be sufficient to fund the Company into 2027 based on current projections. The Offering is expected to close on or about December 10, 2025, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent in connection with the Offering.

The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

(Press release, Aprea, DEC 9, 2025, View Source [SID1234661307])

On December 9, 2025 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT reported that the first patient has been treated in its pilot study for the treatment of patients with recurrent glioblastoma multiforme (GBM) using the Alpha DaRT technology.

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Uzi Sofer, CEO of Alpha Tau, stated, "This is a historic day for Alpha Tau and for GBM patients around the world, with the first treatment ever of a brain cancer using Alpha DaRT. Given the devastating prognosis of GBM, and its high rate of rapid recurrences, generally within 6-9 months, there is a desperate need for new local therapies with an appropriate safety profile for such a critical and sensitive area like the brain. This pilot study is a key part of our broader strategy to bring Alpha DaRT to cancer patients with some of the highest unmet needs, supported by the FDA’s Breakthrough Device Designation and acceptance into the FDA’s prestigious Total Product Life Cycle Advisory Program designed to accelerate the Alpha DaRT treatment to market and to GBM patients who may stand to benefit greatly."

The first patient was treated at The Ohio State University Center 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 for intracranial use.

Dr. Joshua Palmer, commented: "Patients with recurrent glioblastoma face one of the most difficult cancer diagnoses in medicine. There is an urgent unmet need for new therapeutic approaches that can be delivered locally while minimizing harm to surrounding healthy brain tissue. Intratumoral alpha-emitting radiotherapeutics such as Alpha DaRT offer a highly compelling novel scientific approach by delivering potent, short-range radiation precisely where it is needed most."

Dr. J. Bradley Elder, who led the procedure with Dr. Palmer, added: "From a technical standpoint, this procedure demonstrated excellent feasibility. The novel delivery device allowed us to place the Alpha DaRT sources in a precise radial configuration that achieved more than 95% coverage of the tumor volume. Importantly, the system integrates seamlessly as an add-on to the standard brain navigation platform that I use routinely in surgery, making it simple to adopt without disrupting existing workflow."

"This achievement represents the culmination of many years of dedicated teamwork within Alpha Tau – including extensive preclinical research, developing a unique delivery system designed specifically to integrate seamlessly into a standard neurosurgical workflow and, of course, partnership with our wonderful clinical collaborators at OSU," commented Dr. Robert Den, Chief Medical Officer of Alpha Tau. "This is a transformational patient-centric moment of great scientific and clinical significance for the entire field of neuro-oncology."

About the 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 View Source

(Press release, Alpha Tau Medical, DEC 9, 2025, View Source [SID1234661306])