Greenwich LifeSciences Provides Update Showing Continued Reduction in Recurrence Rate in the Open Label Arm of FLAMINGO-01

On March 17, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported a preliminary update showing a continued reduction in the recurrence rate in the fully enrolled, 250 patient, open label non-HLA-A*02 arm of FLAMINGO-01.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

6 Months of Additional Patient Data Since Last Update Shows Recurrence Rate of <1% per Year in Non-HLA-A*02 Patients Treated with GLSI-100, Following Completion of Primary Immunization Series (PIS)

This <1% Annual Recurrence Rate Observed in Non-HLA-A*02 Patients is Statistically Significantly Smaller Than a 4% Annual Recurrence Rate Over a Similar Time Period Observed in the Katherine Study (Kadcyla Treated Arm) Yielding an Approximately 70-80% Reduction in Recurrence Rate as Explained Below
The non-HLA-A*02 arm does not have a direct placebo comparator arm, thus a Kaplan Meier survival analysis is not possible, and the following method was used:

The <1% recurrence rate per year of these 250 treated patients after completing the PIS was compared to the expected historical recurrence rate per year reported for a similar population in the Katherine study who received TDM1 (Kadcyla), which is about 4% recurrences per year or higher in the initial years of the Katherine study. The majority of the treated patients in FLAMINGO-01 also received TDM1 followed by GLSI-100.

As of this data cut, the current recurrence rate of the non-HLA-A*02 patients treated with GLSI-100, following completion of the PIS over an average of 1.2 years of patient exposure, is statistically significantly smaller than a 4% annual recurrence rate over a similar time period observed in the Katherine study (0.7% versus 4% annual recurrence rate over 1.2 patient-years, 83% reduction in recurrence rate, Chi Square, p < 0.005). This preliminary data will continue to be updated and cleaned, so future and final results may vary. Future updates may be presented at upcoming conferences.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
Additional information about the non-HLA-A*02 arm follows:

Virtually all of the non-HLA-A*02 patients have completed the primary immunization series, which is the first 6 monthly vaccinations in the study.

Every 6 months approximately 110 patient-years are added to the non-HLA-A*02 patient data base.

Enhertu (T-DXd) treated patients can be enrolled in FLAMINGO-01. In the future, if Enhertu is approved for high risk patients in the adjuvant setting, more Enhertu treated patients could be enrolled in FLAMINGO-01 and may recur at a lower rate than if treated with Kadcyla. The recurrence rate assumptions in the design of FLAMINGO-01 include this possibility as well as other potential improvements in standard of care.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed compared to the recurrence rates comparable to those observed in the Katherine study of Kadcyla shows an approximately 70-80% reduction in recurrence rate.
This non-HLA-A*02 arm observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.

The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, MAR 17, 2026, View Source [SID1234663613])

Exact Sciences to Present New Molecular Residual Disease and Multi-Cancer Early Detection Data at AACR 2026

On March 17, 2026 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported four presentations at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighting new data in molecular residual disease (MRD) testing and multi-cancer early detection (MCED). The meeting will take place from April 17–22, 2026, in San Diego, CA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Exact Sciences will present new findings from the NSABP B-59/GBG-96-GeparDouze trial evaluating its tumor-informed circulating tumor DNA (ctDNA) test, Oncodetect, in early triple-negative breast cancer (TNBC), along with updated performance data from its multi-biomarker class MCED program supporting the Cancerguard test. Together, these results reinforce the company’s strategy to help detect cancer earlier and monitor disease after treatment.

"Our goal is to use molecular information to guide cancer care at every stage," said Jorge Garces, Ph.D., chief scientific officer at Exact Sciences. "By combining tumor-informed ctDNA analysis with multi-biomarker detection approaches, we’re building tools that give clinicians a clearer view of cancer biology and how disease evolves over time."

Detailed information on the AACR (Free AACR Whitepaper) presentations is provided below:

Expanding the clinical utility of MRD detection in breast and colorectal cancer

Title: Whole-exome sequencing tumor-informed circulating tumor DNA detection after completion of neoadjuvant treatment predicts non-pCR and distant recurrence in patients with early triple-negative breast cancer (TNBC)—Results from a sub-study of the NSABP B-59/GBG-96-GeparDouze Trial
Presenter: Dr. Marija Balic
Session: Saturday, April 18, 2026. Aiming for Cure: Perioperative Clinical Trials
Oral number: CT013
Key findings: Pre-surgery ctDNA status following neoadjuvant therapy (NAT) was strongly associated with both pathologic complete response (pCR) and distant recurrence-free interval (dRFI). These results highlight the potential utility of post-NAT presurgical ctDNA status as an early indicator of treatment resistance and risk stratification.

Title: Investigating the value of testing for actionable alterations and circulating tumor DNA in breast and colorectal cancers
Presenter: Dr. Gargi Basu
Session: Monday, April 20, 2026. Molecular/Cellular Biology and Genetics: Genomic Profiling to Understand Cancer Biology
Poster number: 3243
Location: Poster section 22
Key findings: Comprehensive tumor profiling identified actionable genomic alterations in nearly all breast and colorectal cancer patients tested for ctDNA. Approximately half of the samples had at least one alteration associated with FDA-approved therapies.

Advancing multi-cancer early detection with multi-biomarker innovation

Title: Performance of an optimized methylation-protein multi-cancer early detection (MCED) test classifier
Session: Sunday, April 19, 2026, Clinical Research, Early Detection Biomarkers 1
Poster number: 1109
Location: Poster section 43
Key findings: An optimized methylation–protein (MP V2) multi-cancer early detection classifier demonstrated improved early-stage sensitivity compared with the prior version while maintaining high specificity, supporting its potential to enhance detection of cancers at earlier, more treatable stages.

Title: The complementary contributions of methylation and protein biomarker classes in a multi-cancer early detection (MCED) test
Session: Sunday, April 19, 2026, Clinical Research, Early Detection Biomarkers 1
Poster number: 1108
Location: Poster section 43
Key findings: Results presented demonstrate that methylation and protein biomarker classes provide complementary and independent contributions to cancer signal detection, particularly in early-stage disease, supporting the value of a multi-biomarker approach in MCED testing.

(Press release, Exact Sciences, MAR 17, 2026, View Source [SID1234663612])

Evaxion to present new data at AACR Annual Meeting

On March 17, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology platform, reported two abstracts accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in San Diego, California, April 17-22, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

One abstract will include new biomarker and immunogenicity data for cancer vaccine EVX-01. Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer).

The data stems from the phase 2 trial investigating EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma. Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

The other abstract includes data on the use of AI-Immunology to identify endogenous retrovirus (ERV)-derived neoantigens to include in personalized vaccines to treat glioblastoma, a deadly brain cancer, for which limited therapeutic options exist.

In line with our strategy to identify potential partners and opportunities for both business partnerships and scientific collaborations, we will also participate in the AACR (Free AACR Whitepaper) Oncology Industry Partnering event taking place ahead of the annual meeting.

Presentations details:
Abstract title: AI-designed personalized neoantigen vaccine, EVX-01, induces durable de novo T-cell responses in advanced melanoma patients
Poster#: 7741
Session category: Clinical research
Session title: Immune response to therapies
Location: Poster section 42
Date/Time: April 22, 2026, at 9am-12pm CST/16-19 CET
Presenter: Mads Lausen Nielsen, PhD, Project Manager at Evaxion

Abstract title: Endogenous retrovirus-derived neoantigens enable a personalized cancer vaccine strategy for glioblastoma
Poster#: 6975
Session category: Immunology
Session title: Novel Models of Immunotherapy Response
Location: Poster section 8
Date/Time: April 22, 2026, at 9am-12pm CST/16-19 CET
Presenter: Megan Benz, Duke University Medical Center

(Press release, Evaxion, MAR 17, 2026, View Source [SID1234663611])

Co-PSMA data presented at EAU Annual Congress 2026 with manuscript accepted for publication in the European Urology Journal

On March 17, 2026 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 that the results from the Co-PSMA (NCT06907641)1 IIT were presented by Prof Louise Emmett (St Vincent’s Hospital Sydney) in an oral session at EAU Congress 2026, Europe’s largest urological conference, on the 16th March in London, UK2. The study data has also been accepted for publication in European Urology, the official journal of EAU with an impressive impact factor of 25.2.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Co-PSMA (Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy) was a Phase II IIT evaluating the performance of Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in a head-to-head comparison to SOC 68Ga-PSMA-11 in 50 patients with low PSA (0.2 – 0.75 ng/mL) who were candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy. 68Ga-PSMA-11 PET/CT was followed by 64Cu-SAR-bisPSMA PET/CT (at 1 hour and 24 hours post-injection, same-day and next-day imaging, respectively) on the same digital PET camera.1,3

The primary endpoint of the Co-PSMA study was to assess the difference in mean per patient lesion number. Using a paired means test, a sample size of 50 provided power of 90% to detect a minimum alternative mean difference greater than zero of 0.432. Secondary endpoints included management impact questionnaires between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 and accuracy of the PET findings determined using a comprehensive reference standard, including biopsy, response to targeted treatment without androgen deprivation therapy (ADT), PSA rise without treatment or corroborative imaging.

Overall, 64Cu-SAR-bisPSMA PET/CT (24-hour imaging) was found to identify a higher number of disease recurrences than 68Ga-PSMA-11 PET/CT with substantial management impact and a high true positive rate in men with BCR post-radical prostatectomy.

Participants enrolled had a median PSA of 0.43 (IQR: 0.31 – 0.63) and 74% had an International Society of Urological Pathologists (ISUP) grade of 3 or higher. The mean per-patient lesion for 64Cu-SAR-bisPSMA (24–hour imaging) was 1.26, compared to 0.48 for 68Ga-PSMA-11, with a difference of 0.78 (95%CI: 0.52 – 1.04), ratio 2.63 (95%CI: 1.64 – 4.20) (p <0.0001). In total, 68Ga-PSMA-11 identified 24 lesions across all participants, while 24-hour 64Cu-SAR-bisPSMA imaging detected 63 lesions (representative image in Figure 1). The increase in the number of lesions identified by 64Cu-SAR-bisPSMA was noted in the prostatic bed region (local recurrence), pelvic/extra-pelvic lymph nodes and bone .

On a per patient level, 36% (18/50) of participants were positive on 68Ga-PSMA-11 PET/CT, compared to 78% (39/50) on 64Cu-SAR-bisPSMA PET/CT (next-day imaging). Planned patient management changed following the assessment of the 64Cu-SAR-bisPSMA scans in 22/50 (44%) trial participants. Among the participants with an evaluable standard of truth (SOT), the true positive rate was 71% for 24-hour 64Cu-SAR-bisPSMA (24/34) compared to 29% (10/34) for 68Ga-PSMA-11. The false negative rate was 21% for 24-hour 64Cu-SAR-bisPSMA (7/34) vs. 65% for 68Ga-PSMA-11 (22/34).

These results from the Co-PSMA IIT further build on the growing body of evidence demonstrating that 64Cu-SAR-bisPSMA improves the detection of prostate cancer compared to the current SOC PSMA PET agents which have lower sensitivity in patients with low PSA levels4,5. In the Phase II COBRA trial, 64Cu-SAR-bisPSMA was evaluated in patients with BCR who had a negative or equivocal scan at study entry. Among participants with a follow-up SOC PSMA PET, 90% were positive on 24-hour 64Cu-SAR-bisPSMA PET compared with only 60% on SOC PSMA PET. Overall, next-day imaging with 64Cu-SAR-bisPSMA identified more than 2.6 times lesions than SOC PSMA PET6. The COBRA data, combined with the Co-PSMA IIT results, will complement the anticipated findings from the Phase III registrational trial, AMPLIFY, which recently reached its target number of participants7. Together, they are intended to be submitted to the US FDA for a market authorisation of 64Cu-SAR-bisPSMA in patients with BCR of prostate cancer.

Prof Louise Emmett (St Vincent’s Hospital Sydney), Principal Investigator in the Co-PSMA trial, commented, "Head-to-head trials are very important in helping clinicians determine the most appropriate products for their patients. The Co-PSMA study shows that a novel PSMA-targeted PET agent like 64Cu-SAR-bisPSMA can deliver improved imaging performance compared to other SOC PSMA agents. In Co-PSMA, 64Cu-SAR-bisPSMA at 24 hours identified more sites of recurrence and directly informed personalised treatment decisions, highlighting its potential to improve outcomes in prostate cancer patients with BCR."

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "Science underpins the entirety of our biotechnology sector, and as a science-driven organisation, nothing makes us more proud than to see our products progress from the Australian benchtop to now generating excellent results in the clinic and having this substantiated and quantified to the highest standard through the scientific method. We applaud the independent work of Prof Louise Emmett and her team at St Vincent’s Hospital in Sydney who chose to progress this trial in such detail, leading to the acceptance of the data in European Urology, a top-tier journal with a high impact factor of 25.2.

"The high quality of these data now adds to the substantial body of evidence supporting our product, the optimised SAR-bisPSMA. The discovery and pre-clinical work has been previously circulated in numerous journals, including publications by our long-term collaborator, Prof Paul Donnelly, sharing his seminal work on the sarcophagine (SAR) chelator as well as on the SARTATE, SAR-Bombesin and the optimised SAR-bisPSMA agents in 2023 in Chemical Reviews8, one of the highest impact factor journals in chemistry with a 5-year impact factor of 67.5.

"The extraordinary quality of the academic research is coupled with the feverish pace of commercialisation where our registrational Phase III trials, AMPLIFY and CLARIFY, are nearing completion. We have recently shared that AMPLIFY reached its target number of participants with rising or detectable PSA after initial definitive treatment at clinical sites across the US and Australia in just 9 months since imaging the first patient7, and we look forward to collecting and analysing the final study data. Combined with results from the Co-PSMA and COBRA trials, we believe it will constitute a compelling application for approval of 64Cu-SAR-bisPSMA by regulatory authorities for the BCR indication. Armed with three Fast Track Designations for the one SAR-bisPSMA agent, we are ready to work closely with the US FDA to get it to patients in need as soon as possible, and we look forward to more positive interactions with the Agency on this journey. As always, we will continue updating the market on the progress of our bisPSMA program, including significant milestones in the AMPLIFY, CLARIFY and SECuRE trials, as well as on the supply chain and regulatory developments as we enter the market with our first product."

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary SAR technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide9. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates there will be about 333,830 new cases of prostate cancer in the US in 2026 and around 36,320 deaths from the disease.

(Press release, Clarity Pharmaceuticals, MAR 17, 2026, View Source [SID1234663610])

Can-Fite Expands Namodenoson anti-Obesity Franchise with Israeli Patent Allowance

On March 17, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that the Israeli Patent Office has allowed its patent application No. 284463, titled "An A3 Adenosine Receptor Ligand for Use for Achieving a Fat Loss Effect." The allowed patent covers the use of A3 adenosine receptor (A3AR) agonists, including the Company’s lead drug candidate Namodenoson, for inducing fat loss and treating obesity and related metabolic disorders.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This allowance represents a key addition to Can-Fite’s expanding global intellectual property portfolio around Namodenoson’s anti-obesity activity and follows similar patent advancements in other major jurisdictions including the US, Canada and Australia, strengthening the Company’s worldwide protection strategy. Recently the technology granted scientific recognition upon coming up with a breakthrough publication of peer-reviewed study in the International Journal of Obesity, demonstrating the anti-obesity effect of namodenoson (View Source ).

The global obesity therapeutics market is experiencing rapid growth, driven by increasing prevalence and the success of GLP-1 receptor agonists. However, current treatments are often associated with limitations including gastrointestinal side effects and high cost. Namodenoson, a highly selective A3AR agonist, offers a differentiated mechanism of action, targeting key pathways involved in adipogenesis, inflammation, and metabolic regulation. Preclinical and clinical studies have demonstrated its potential to reduce fat accumulation and improve metabolic profiles, positioning it as a promising candidate in the expanding obesity treatment landscape.

"With the allowance of this patent in Israel, we continue to build and strengthen our intellectual property portfolio around Namodenoson’s anti-obesity activity," said Dr. Pnina Fishman, Chairperson and Chief Scientific Officer of Can-Fite. "Given the significant unmet need and rapid growth of the obesity market, we believe Namodenoson’s unique mechanism and established safety profile position it as an attractive candidate for development and potential partnering opportunities."

The global obesity treatment market is projected to reach $60.5 billion by 2030, growing at a compound annual growth rate (CAGR) of approximately 22%, driven by increasing disease prevalence and demand for safe, effective oral therapies.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

(Press release, Can-Fite BioPharma, MAR 17, 2026, View Source [SID1234663609])