On December 10, 2025 IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, reported that four abstracts featuring data from independent studies conducted by ProSense users were accepted and presented at the Radiological Society of North America’s ("RSNA") Annual Meeting, which took place from November 30 to December 4, 2025 in Chicago, Illinois.

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The RSNA’s Annual Meeting, the world’s largest radiology conference with around 50,000 attendees from 160 countries, is a prestigious global platform for presenting clinical data. The acceptance of four abstracts this year, each showcasing results achieved with IceCure’s technology, represents another significant international recognition of the effectiveness and growing adoption of ProSense by the medical community for the treatment of breast cancer.

"The broad range of independent studies conducted, peer reviewed, published and presented by ProSense users supports the widescale adoption of our cryoablation system and is highly encouraging for women who seek a non-surgical option," said Eyal Shamir, IceCure’s Chief Executive Officer. "At RSNA 2025, radiologists from across the U.S. and the globe gathered to learn about the latest technologies that can lead to better patient outcomes, and we are proud that ProSense was presented to these doctors. We continue to see growing interest in ProSense following the U.S. Food and Drug Administration’s ("FDA") recent marketing approval in low-risk breast cancer."

Independent studies presenting data on ProSense included the following:

1. Abstract Title: Ultrasound-guided Cryoablation for Breast Cancer in Non-Surgical Patients

Key Finding: PCA was successful in 100% of luminal cancers up to 2.5 cm

Researchers (Spain): Laura Abelairas Lopez, MD, Lucia Grana Lopez, MD, Laura Lopez, MD, Ignacio Fernandez Sobrado

Purpose: To present a single-center experience on the use of percutaneous cryoablation ("PCA") for the local control of breast cancer ("BC") in patients who elect not to undergo a surgery or were considered inoperable

Results: 73 women who were considered inoperable were treated under local anesthesia with PCA. 69 of them (median age 87 years, range 48-98 years) had at least one imaging examination performed 6 months after the procedure. Median tumor size was 23 mm, range 6-46 mm. The mean follow-up was 19.8 months (range 6-45 months). 60 patients were luminal BC, 3 were Her2 (+) and 8 were triple negative tumors. All luminal cancers received endocrine therapy. Complete tumoral necrosis was achieved in 56 tumors (81.2%). There was axillary progression in two triple negative BC. Recurrence in a different location was diagnosed in two patients. PCA was successful in 100% of luminal cancers up to 2.5 cm. No major complications were seen and the procedure was well tolerated.

Conclusions: Percutaneous cryoablation is a minimally invasive procedure, without significant complications. It could be a safe alternative to surgery for the management of early-stage breast cancer.

2. Abstract: Non-Surgical Treatment of Breast Cancer: A Comparison of Outcomes Between Cryoablation with Hormonal Therapy Versus Cryoablation Alone and Hormonal Therapy Alone in Patients Not Eligible for Surgery

Key Finding: Statistically significant difference between the Cryoablation-with-HT and the HT-only groups, expressing the added value of Cryoablation

Researchers (Italy): Federica Di Naro, MD, Sofia Elisabetta Baldi Giorgi, Francesca Pugliese, MD, Sofia Vidali, Tommaso Amadori, MD, Diego De Benedetto, Jacopo Nori Cucchiari

Purpose: To evaluate the most effective non-surgical treatment for breast cancer in surgery-ineligible patients, comparing ultrasound-guided Cryoablation combined with hormonal therapy (HT) versus Cryoablation alone and hormonal therapy alone

Results: 111 patients (mean age 81.2 years, ±11.3) not-suitable for surgery due to comorbidities and/or advanced age were enrolled, with a total of 125 biopsy-confirmed malignant breast lesions. Tumor size reduction was significantly different between the groups (P=0.0005), with greatest reduction in the Cryoablation-with-HT group (83.3%, mean reduction of 13.6 mm), followed by Cryoablation-only (61.7%, mean reduction of 8.2 mm), and HT-only (42.1%, mean reduction of 7.4 mm). Tumors with complete remission (CR, RECIST 1.1) were similar between the Cryoablation-with-HT and Cryoablation-only groups (74.4% and 78.3%, respectively), followed by the HT-only (36.1%). Pairwise comparisons revealed a significant difference between the Cryoablation-with-HT and the HT-only groups for Contrast-Enhanced Mammography ("CEM")-enhancement, size reduction (%), and CR, expressing the added value of Cryoablation (P=0.0041, P<0.0001 and P<0.0001, respectively).

Conclusions: Cryoablation with hormonal-therapy significantly reduces tumor size and residual disease more effectively than therapy alone, making it a promising option for patients not-eligible for surgery.

3. Abstract Title: Correlation of Lesion Conspicuity in Contrast-Enhanced Mammography (CEM) with Tru-Cut Scar Biopsy Results in the Assessment of Ultrasound-Guided Cryoablation Outcome

Key Finding: Significant association between biopsy and lesion conspicuity on CEM

Researchers (Spain): Federica Di Naro, MD, Francesca Pugliese, MD, Sofia Elisabetta Baldi Giorgi, Giuliano Migliaro, MD, Giulia Bicchierai, Chiara Bellini, MD, Jacopo Nori Cucchiari

Purpose: To evaluate the role of lesion conspicuity at 12-month CEM follow-up as a predictor of cryoablation outcome

Results: 79 patients (mean age 85.7 years old, ±6.0) with biopsy-proven malignant breast lesions ≤35 mm, underwent ultrasound-guided cryoablation. Among the 79 patients, 48 (60.8%) underwent both CEM and Biopsy at 12 months. Among them, 35 (61.4%) lesions showed no enhancement. Among the 22 (38.6%) lesions showing enhancement, 6 had low LC, 11 moderate LC, and 5 high LC. A significant fair agreement (Cohen’s Kappa coefficient = 0.32 [95% CI: 0.11-0.52]) between CEM and biopsy was shown. Fisher’s exact test P-value was 0.0003 reflecting a significant association between biopsy and conspicuity. Lesions with absent or low LC correlated with negative histology (B2), while lesions with residual malignant histology (B5) were associated with moderate-high LC. In assessing cryoablation efficacy, CEM demonstrated negative predictive value (NPV) of 100%, Sensitivity of 100%, Specificity of 68.6% and positive predictive value (PPV) of 27.3%.

Conclusions: Lower lesion conspicuity on CEM indicates higher cryoablation success, useful for follow-up.

4. Abstract Title: Imaging Findings After Cryoablation of Breast Cancer: Tips and Tricks to Know That the Procedure was Successful Without Biopsy

Researchers (Spain): Laura Abelairas Lopez, MD, Lucia Grana Lopez, MD, Laura Lopez, MD, Ignacio Fernandez Sobrado

Teaching Points: Described the findings on mammography, ultrasound, and CEM after PCA of breast BC, as well as the signs of residual tumor or recurrence.

About ProSense

The ProSense Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company’s website.

ProSense is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.

ProSense enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense opens the door to fast and convenient office-based procedures for breast tumors.

(Press release, IceCure Medical, DEC 10, 2025, View Source [SID1234661359])

On December 10, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IDE574, a potential first-in-class KAT6/7 dual inhibitor with high selectivity over related KAT5/8 enzymes. The company is targeting to begin a Phase 1 dose escalation trial of monotherapy IDE574 in the first quarter of 2026.

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"IDE574 is a promising potential first-in-class molecule that potently inhibits two tumor-promoting epigenetic modulators, KAT6 and KAT7, while sparing other structurally similar KAT family members. Preclinical studies demonstrate KAT6 and KAT7 collaboratively control lineage-specific tumorigenic transcription factor activity essential for tumor cell proliferation and survival. Dual KAT6/7 inhibition by IDE574 disrupts tumor lineage identity and delivers robust anti-tumor activity in patient-derived lung and breast cancer xenograft models dependent upon lineage-specific transcription factor activity," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences.

IDE574 is an equipotent, highly selective, small molecule dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7, both of which have been shown to support cancer cell survival. IND-enabling studies support the potential clinical evaluation of IDE574 monotherapy in patients with hormone receptor-positive breast cancer, lung adenocarcinoma as well as additional opportunities associated with lineage addiction. IDEAYA is targeting to share data from its preclinical work with IDE574 at a medical conference in the first half of 2026.

(Press release, Ideaya Biosciences, DEC 10, 2025, View Source [SID1234661358])

On December 10, 2025 Bantam Pharmaceutical, a clinical-stage company pioneering mitochondrial biology to develop first-in-class medicines for treating aggressive cancers, reported that the first patient was treated at The Princess Margaret Cancer Centre in Toronto, Canada in its Phase 1 clinical trial studying BTM-3566.

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This milestone is an important step as the company begins testing the safety, tolerability, and early signs of effectiveness of BTM-3566 in patients. BTM-3566 is a new type of medicine that targets aggressive cancers by modulating a stress pathway inside cells which may help patients whose cancer has worsened after other treatments.

This first-in-class small molecule works by activating the OMA1-ATF4 integrated stress response (ISR) pathway – a newly described mechanism that governs mitochondrial functions and how cells respond to stress. Instead of targeting an individual protein and its cancer-driver mutations, BTM-3566 specifically uses the machinery of the cancer cell to trigger cell death, making it an ideal treatment option for patients whose cancers no longer respond to standard therapies.

"Enrolling the first patient in our Phase 1 trial is a pivotal milestone in our clinical development efforts," said Michael Stocum, President & CEO of Bantam Pharmaceutical. "Princess Margaret Cancer Centre is an esteemed institution, and we are proud to collaborate with their expert investigators to advance this study for patients with limited treatment options."

Bantam’s Phase 1 program is active in both the U.S. and Canada to study BTM-3566 in lymphomas and solid tumors. The lymphoma cohort includes patients with relapsed/refractory mature B-cell lymphomas. The solid tumor cohort includes a broad range of cancers such as head and neck, lung, gastroesophageal/gastrointestinal, colorectal, sarcomas, uterine, renal and bladder, among others.

"Princess Margaret Cancer Centre is excited to be the first institution to enroll a patient in Bantam’s study of this novel therapeutic approach for those who no longer respond to standard treatments," said Dr. Albiruni Razak, Medical Oncology Lead, Sarcoma at the Princess Margaret Cancer Centre.

Bantam expects to have early information from the first patient available during J.P. Morgan Week in January 2026, along with a full summary of all non-clinical monotherapy and combination data underpinning its regulatory filings in the US and Canada.

For information about the ongoing U.S. trials, visit ClinicalTrials.gov and search NCT06792734 and NCT07266285. For information about the ongoing Canadian trial, visit ISRCTN.com and search ISRCTN15438979.

About BTM-3566

BTM-3566 is a first-in-class small molecule targeting aggressive cancers by activating the OMA1-ATF4 ISR pathway—a newly described mechanism that governs mitochondrial homeostasis and cell survival under stress. Unlike many therapies that target specific tumor mutations, this approach triggers intrinsic apoptotic pathways by modulating mitochondrial function, making it an ideal treatment option when patients progress.
In pre-clinical studies, BTM-3566 demonstrated potent anti-cancer activity, showing complete regressions in patient-derived xenograft (PDX) models of aggressive B-cell lymphomas, including double- and triple-hit DLBCL and in MCL PDX models from patient tumors that progressed on rituximab, BTK inhibitors and CAR-T therapies. BTM-3566 exhibits activity in solid tumors, including tumor regressions in multiple PDX models, where low FAM210B RNA expression is a potential biomarker for patient selection. BTM-3566 also exhibits strong synergy in combination with other drugs, including BH3 mimetics, hypomethylating agents and rituximab, enabling both monotherapy and combination development strategies.

(Press release, Bantam Pharmaceutical, DEC 10, 2025, View Source [SID1234661357])

On December 10, 2025 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported that the Company was selected for a Product Development Research Grant through The Cancer Prevention and Research Institute of Texas (CPRIT), an award valued at more than $7 million. The Company was selected for funding as one of nine awardees out of 164 applicants for its proposal titled ‘Advancing DOC1021: Phase 1/2 Refractory Melanoma Study,’ which aims to expand DOC1021 into early-stage clinical development in a third target indication.

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"We are honored to have CPRIT’s support as we bring DOC1021 into a new and critically underserved indication," said Jay Hartenbach, President and COO of Diakonos Oncology. "Across more than two dozen preclinical tumor models and multiple clinical indications, our personalized dendritic cell vaccine platform has shown a consistent pattern of potent immune activation and efficacy. With CPRIT’s support, we are now able to evaluate whether these same immune mechanisms can also benefit patients with refractory melanoma, a population with significant unmet medical need."

Melanoma is a serious and often aggressive form of skin cancer that arises from melanocytes, the pigment-producing cells in the skin. While many cases can be treated effectively when detected early, some patients experience disease progression despite available therapies such as immune checkpoint inhibitors or targeted therapies. In the case of refractory melanoma, the disease no longer responds to immune checkpoint inhibitors, resulting in limited options and poor clinical outcomes. Diakonos’ planned Phase 1/2 study will evaluate the safety and preliminary efficacy of DOC1021, along with ctDNA and immune biomarker responses, in this particularly high-need patient population.

"Despite the remarkable progress made with targeted therapies and immune checkpoint inhibitors, patients with refractory melanoma still have very limited options," said Ryan J. Sullivan, MD, Director of the Cutaneous Medical Oncology Program at Massachusetts General Brigham Cancer Institute. "DOC1021’s personalized dendritic cell approach, which presents each patient’s own tumor antigens in a viral-mimicking context, offers a compelling new way to re-engage the immune system against tumors that have escaped standard therapies. This trial will allow us to rigorously evaluate whether that biology can translate into meaningful benefit for this high-risk patient population."

Enrollment in the Phase 1 clinical study of DOC1021 for patients with refractory melanoma is expected to begin in January 2026, representing an important step forward in the Company’s efforts to advance this investigational therapy into early-stage clinical development.

About DOC1021

DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that uniquely combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.

The unique double-loading approach, which mimics a viral infection, unlocks a synergistic and exponentially more powerful tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient’s immune cells for manufacturing and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 allows for simple administration in the outpatient setting and broad reach via community cancer centers.

Diakonos currently has two active clinical trials with DOC102, a Phase 1 pancreatic cancer study (NCT04157127) and a Phase 2 glioblastoma (GBM) study (NCT06805305). Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs, in October 2023 and May 2024, respectively. The company also received Orphan Drug Designation for the GBM program in January 2024. The refractory melanoma Phase 1/2 study with DOC1021 will be initiated with the facilitation and support of the Cancer Prevention and Research Institute of Texas (CPRIT).

(Press release, Diakonos Oncology, DEC 10, 2025, View Source [SID1234661356])

On December 10, 2025 at the San Antonio Breast Cancer Symposium (SABCS), researchers reported the initial findings from a major multi-year collaboration between the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and Caris Life Sciences (Caris) focused on transforming recurrence risk assessment in early-stage breast cancer through artificial intelligence (AI). The public-private partnership pairs ECOG-ACRIN’s extensive clinical trial expertise and biorepository resources with Caris’ comprehensive MI Cancer Seek whole exome and whole transcriptome profiling, whole slide imaging, and advanced machine learning platforms.

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The research teams developed multimodal models to more precisely stratify recurrence risk in early-stage breast cancer. The models integrate histopathologic imaging, clinical, and molecular data generated from TAILORx, one of the world’s largest and most rigorously annotated breast cancer research repositories. This level of multimodal integration is unprecedented at this scale in early breast cancer prognostication.

Early-stage breast cancer represents a large and heterogeneous patient population in which treatment decisions frequently hinge on uncertain recurrence risk. Of the approximately 310,720 new cases diagnosed in the United States each year, an estimated 60% are early-stage (American Cancer Society), underscoring the broad application and clinical relevance of more accurate and individualized risk assessment.

"Realized through collaboration between ECOG-ACRIN, NCI, and Caris Life Sciences, this public-private partnership represents a methodological, logistical, and collaborative integration of datasets from the historically impactful TAILORx trial to further extend the benefits for breast cancer patients," said ECOG-ACRIN Group Co-Chair Peter J. O’Dwyer, MD. "The advance in personalized medicine afforded in this work, in turn, helps to advance the potential of AI to refine treatment and improve outcomes."

Across analytic evaluations, the multimodal AI models demonstrated enhanced prognostic performance compared to existing recurrence-risk assessment methods, highlighting their potential to support more personalized treatment decision-making in early-stage breast cancer.

"By integrating imaging, clinical data, and molecular profiling, we are advancing beyond single-dimension diagnostics to deliver a more precise and comprehensive understanding of recurrence risk in breast cancer," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "The development of these models underscores the transformative power of multimodal AI and machine learning in precision oncology."

Both AI models-including development approaches, integrated biomarker features, and demonstrated prognostic improvements- were presented in today’s SABCS sessions.

Multimodal Artificial Intelligence (AI) Models Integrating Image, Clinical, and Molecular Data for Predicting Early and Late Breast Cancer Recurrence in TAILORx, presented by Joseph A. Sparano, MD (Mount Sinai Tisch Cancer Center). Late-Breaking Abstract GS1-08 was presented during SABCS General Session 1.

In this project, researchers developed and prospectively validated a multimodal model integrating pathomic imaging (I), clinical (C), and expanded molecular (M+) data from 4,462 TAILORx tumor specimens. The expanded M+ gene expression panel includes 42 tumor genes associated with breast cancer recurrence derived from five commercially available gene assays, including the Oncotype DX (ODX) 21-gene recurrence score and a set of highly variable genes. Based on the results of the TAILORx trial, ODX is widely used in clinical practice for its prognostic information on recurrence and predictive information on chemotherapy benefit; however, its ability to forecast recurrence beyond the 5-year mark is limited.

The findings from this study will ultimately provide crucial support for the development of a new diagnostic test for women with HR-positive, HER2-negative, node-negative breast cancer that more accurately estimates recurrence risk, especially late recurrence 5 or more years after diagnosis.

"Although the TAILORx trial was the first randomized trial to establish the role of the 21-gene recurrence score to guide chemotherapy use in early breast cancer, our goal was to take one step further in personalizing cancer therapy by developing a new diagnostic test using tumor specimens derived from the trial," said Dr. Sparano.

Dr. Sparano noted that the team developed an AI model that evaluates not only tumor gene expression but also uses deep learning of digitized H&E slides used for routine pathologic assessment to provide better prognostic information about cancer recurrence risk.

"We found that the expanded gene panel was a strong predictor of early recurrence within 5 years after diagnosis, the pathomic imaging was a strong predictor of late recurrence after 5 years, and when combined, a test which added both features to the prognostic information provided by clinicopathologic factors was the strongest predictor of distant recurrence out to 15 years," he said.

A Multimodal-Multitask Deep Learning Model Trained in NSABP B-42 and Validated in TAILORx for Late Distant Recurrence Risk in HR+ Early Breast Cancer, presented by Eleftherios (Terry) Mamounas, MD, MPH (NSABP Foundation, Inc. and AdventHealth Cancer Institute). Abstract RF3-07 was presented during SABCS Rapid Fire Session 3.

Patients with early-stage, hormone receptor–positive (HR+) breast cancer are at risk for distant recurrence several years after diagnosis and initial treatment, making long-term risk assessment critical. Assessment of clinical factors alone (tumor size, grade, node status) is insufficient for precise risk stratification. Furthermore, there is a lack of personalized tools to guide decisions about the use of extended endocrine therapy (EET) beyond the standard 5 years.

Dr. Mamounas presented a multimodal–multitask deep learning algorithm designed to estimate late distant recurrence (DR) risk and help identify patients most likely to benefit from EET. Originally developed and validated in the NSABP B-42 randomized phase 3 trial, the model demonstrated strong prognostic performance, identifying those with minimal recurrence risk after a standard 5-year course of adjuvant endocrine therapy who could be spared additional treatment.

The ECOG-ACRIN/Caris research team conducted a new external validation study of the model in 4,300 patients from the TAILORx trial. In TAILORx, the model demonstrated robust late distant recurrence prognostication independent of other known prognostic factors, supporting its potential clinical utility as a scalable, cost-effective alternative to genomic assays using routine H&E and clinical data.

(Press release, ECOG-ACRIN, DEC 10, 2025, View Source [SID1234661355])