Belenos Pipeline Updates: First Clinical Data from Lead Asset BEL512, a Long-lasting Bispecific Targeting TSLP and IL-13, Second Asset BEL336, a First-in-class Long-acting Bispecific Targeting OX40L and IL-13, Phase 1 to Start 1Q2026




Belenos Pipeline Updates: First Clinical Data from Lead Asset BEL512, a Long-lasting Bispecific Targeting TSLP and IL-13, Second Asset BEL336, a First-in-class Long-acting Bispecific Targeting OX40L and IL-13, Phase 1 to Start 1Q2026

SARASOTA, Fla.–(BUSINESS WIRE)–Belenos Biosciences Inc.:

• BEL512:
  • Support for Extended Dosing Intervals: Subcutaneous BEL512 (CM512) demonstrated long half-life of up to 70 days
  • Clinical Improvements: Patients dosed on Day 1, Day 15, and Day 29 achieved EASI-75 quickly at Week 6 and were maintained for over 12 weeks
  • Key Biomarker Suppression: Key biomarkers of inflammation decreased, including TARC, IgE, IL-13, TSLP, and eotaxin-3
  • Favorable Safety: Well-tolerated with no safety concerns identified, similar TEAE incidence across placebo and treatment groups
  • US Study Ongoing in Asthma, Broad Potential Across Multiple Indications: Belenos’ Proof-of-Concept study of ‘512 in patients with mild-moderate Asthma in the U.S. expected to readout in 2026. Five Phase 2 studies ongoing in China in Chronic Obstructive Pulmonary Disorder, asthma, Chronic Rhinosinusitis with Nasap Polyps, Chronic Spontaneous Urticaria and AD.
• BEL536:
  • First-in-Class Long-acting Bispecific Targeting OX40L/IL-13: CTN filed in Australia with target of initiating Phase 1 study in 1Q2026

Belenos Biosciences Inc., a private, clinical-stage biotechnology company today announced that its China partner Keymed Biosciences has reported topline results from a Phase 1b study (n=46) of BEL512 (CM512), exploring preliminary efficacy in patients with moderate-to-severe AD. Three treatments given over one month led to rapid, deep, and sustained improvements across all clinical endpoints, decreases in key inflammatory biomarkers, a favorable safety profile and pharmacokinetics supportive of long-interval dosing.

‘512 is a novel TSLP/IL-13 bispecific engineered with half-life extension. The Phase 1b testing two doses (300 mg and 600 mg) of BEL512 vs placebo highlighted significant and durable responses:

• EASI 75 300 mg group at week 6 of 50% vs 7% in placebo groups
• EASI 75 300 mg group at week 12 of 58% vs 21.4% in placebo groups
• EASI 90 300 mg group at week 12 of 41.7% vs 0% in placebo groups

These improvements were sustained through to week 24, 20 weeks after the last dose of ‘512. Both serum TSLP and IL-13 rapidly decreased after initial dose, reaching levels below the lower limit of quantification. TARC, eotaxin-3, CCL13, and IgE decreased after the first dose, and reductions were sustained through the 24 week study.

The Phase 1b study was conducted in China, and sponsored by Keymed Biosciences Ltd., (NCT06553209). It is the first study of a bispecific agent to report results in this patient population.

Belenos’ second asset, BEL536, is a first-in-class long-acting bispecific antibody developed by Keymed Biosciences and is being advanced into clinical studies by Belenos. By targeting OX40L and IL-13 it is designed to both treat symptoms and signs of disease rapidly through blockade of IL-13 and OX40L, but also with the intent of getting patients into durable disease remission.

“These first patient data underscore the potential ‘512 has to deliver rapid, deep, durable disease control,” said Donnie McGrath, MD, CEO of Belenos Biosciences Inc. “The arrival of the first patient data for ‘512, and the imminent start of our Phase 1 study for BEL536 represent significant milestones for the company. Looking ahead to the completion of our ‘512 asthma study in the U.S. and the multiple ‘512 phase 2 studies our partners at Keymed are conducting in China means that in 2026 the ‘512 program will have several clinical read-outs to support moving toward pivotal programs in 2027,” Dr. McGrath continued.

About Belenos

Founded in 2024, Belenos Biosciences is a clinical-stage biotechnology company developing transformative therapies with the goal to restore immune balance, improving clinical outcomes and achieving disease remission for patients with chronic inflammatory diseases. Belenos licensed all ex-China rights for BEL512 and BEL536 from Keymed Biosciences Ltd. www.belenosbio.com

Contacts

Megan Dow, Ph.D., COO

IR@belenosbio.com

Northwell’s Dr. Stacey E. Rosen delivers Presidential Address at the American Heart Association’s Scientific Sessions 2025




Northwell’s Dr. Stacey E. Rosen delivers Presidential Address at the American Heart Association’s Scientific Sessions 2025

NEW HYDE PARK, N.Y.–(BUSINESS WIRE)–Stacey E. Rosen, MD, a cardiologist and executive director of Northwell Health’s Katz Institute for Women’s Health and the 2025-2026 volunteer president of the American Heart Association, delivered a poignant and powerful Presidential Address at the opening of the Association’s Scientific Sessions 2025, which took place November 7-10. Her keynote speech, which kicked off the annual conference, challenged decades of male-centric research, outlining a transformative vision for the future of women’s cardiovascular and cerebrovascular health and calling for a fundamental shift in scientific inquiry and clinical practice.

Addressing an audience of more than 10,000 leading cardiologists, researchers, and media, Dr. Rosen opened with a compelling analogy of two babies, her son and daughter, born on the same day in 1992. She lamented how, historically, her son and other boys around the world would benefit from a vast body of sex-specific research, prevention strategies and treatment options, while for girls it was “not so much.”

“For too long, it was widely believed that human hearts were human hearts, and human brains were human brains,” Dr. Rosen explained, leading scientists to study men and simply apply any findings to women. This flawed approach persisted because, as she noted from discussions with leading experts in the past. “We didn’t think it mattered,” said Dr. Rosen, senior vice president of Women’s Health at Northwell.

Dr. Rosen traced the origins of this male-centric model back to the 1940s, highlighting how early population studies identifying risk factors for coronary artery disease predominantly included only men. While advancements led to decreasing heart disease mortality rates for men, women’s mortality rates continued to rise, eventually surpassing men’s, and the gap widened. This critical disparity spurred a series of pivotal initiatives, including the establishment of the NIH’s Office of Research in Women’s Health and groundbreaking studies that began to uncover sex-differentiated mechanisms of heart disease.

Despite significant progress, Dr. Rosen emphasized that serious questions remain, such as why women with diabetes have a markedly different risk factor profile than men, why women are more prone to migraines with aura (a stroke risk factor), and why mechanisms of sudden cardiac death differ by sex.

Her remarks ended with a powerful call for action and an appeal for broader engagement. Dr. Rosen stressed that improving women’s health requires more than just women scientists and clinicians.

“Women trying to answer these critical questions don’t need men merely as allies … what we really need are men as accomplices to improve the heart and brain health of women!” she asserted, challenging the audience to “make a name for yourself” by pursuing groundbreaking science in this vital area.

“Dr. Rosen’s Presidential Address was a bold and inspiring call to action that underscores the urgent need to transform how we approach women’s cardiovascular health,” said Nancy Brown, CEO of the American Heart Association. “Dr. Rosen has been a longtime volunteer and tireless advocate for the American Heart Association’s Go Red for Women movement and has championed initiatives like our Research Goes Red and the Go Red for Women Venture Fund. These programs are driving innovation, amplifying women’s voices and accelerating solutions that improve outcomes for all women.”

The American Heart Association’s Scientific Sessions is the world’s premier cardiovascular conference, bringing together basic scientists, clinicians, and researchers from across the globe. This annual event serves as a critical platform for presenting the latest groundbreaking science, research and advances in cardiovascular medicine. Attendees engage in learning, networking and collaboration, shaping the future of heart and brain health through the unveiling of new guidelines, pivotal trials and innovative therapies across a wide spectrum of specialties. Having taken the helm as the Association’s volunteer president in June, Dr. Rosen helps share insights to guide the strategic direction of various Association committees.

At Northwell, Dr. Rosen oversees Northwell’s Katz Institute for Women’s Health. Its mission is to improve the health of women throughout their lives, bridging the gap between wellness and personalized care delivery. With a dedicated focus on women, the Katz Institute offers a comprehensive approach and sets the standards for excellence in patient-centered women’s health care. It also serves as a convener and amplifier for all of Northwell’s women’s health initiatives, including supporting sex- and gender-specific research, providing expert, coordinated clinical care and educating the community on prevention and well-being.

About Northwell Health
Northwell is the largest not-for-profit health system in the Northeast, serving residents of New York and Connecticut with 28 hospitals, more than 1,000 outpatient facilities, 22,000 nurses and over 20,000 physicians. Northwell cares for more than three million people annually in the New York metro area, including Long Island, the Hudson Valley, western Connecticut and beyond, thanks to philanthropic support from our communities. Northwell is New York State’s largest private employer with over 104,000 employees – including members of Northwell Health Physician Partners and Nuvance Health Medical Practices – who are working to change health care for the better. Northwell, named a TIME100 Most Influential Companies 2025, is making breakthroughs in medicine at the Feinstein Institutes for Medical Research. Northwell is training the next generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and the Hofstra Northwell School of Nursing and Physician Assistant Studies. For information on our more than 100 medical specialties, visit Northwell.edu and follow us @NorthwellHealth on Facebook, X, Instagram and LinkedIn.

Contacts

Matthew Libassi

631-793-5325

mlibassi@northwell.edu

LIB Therapeutics Announces Results from Late Breaking Science Presentation at 2025 American Heart Association Meeting in New Orleans November 9, 2025




LIB Therapeutics Announces Results from Late Breaking Science Presentation at 2025 American Heart Association Meeting in New Orleans November 9, 2025

CINCINNATI–(BUSINESS WIRE)–LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep (Lerochol®), a novel, monthly, small dose third-generation PCSK9 inhibitor today announced results from Late Breaking Science presentations at the November 7-10th 2025 American Heart Association meeting in New Orleans.

• Long-term Efficacy and Safety of Lerodalcibep in the Open-label 72-week Extension Study of Subjects Previously on Inclisiran or Lerodalcibep in the LIBerate-VI Trial – Dr Evan Stein MD PhD November 9th

• Lerodalcibep demonstrated consistent long-term efficacy in those continued on the drug and was well tolerated, with no treatment related serious adverse events.
• 72-week primary endpoint; mean & absolute LDL-C reductions of 59.2% & 66.6 mg/dL respectively.
• Mean ApoB was reduced by 45.3% and median Lp(a) by 35.5%.
• Subjects switched from Inclisiran to Lerodalcibep had:

• Substantial additional LDL-C reductions from the end of the base trial of ~40% through week 48 and 30% lower through week 72.
• Additional large reductions in Apo B and Lp(a) and
• Significant increase in subjects achieving guideline LDL-C targets.

“The study is the first to assess a plasma binding PCSK9 inhibitor, Lerodalcibep, in patients switched from a hepatic PCSK9 synthesis inhibitor and which showed synergistic efficacy, further reducing LDL-C, Apo B and Lp(a) and increased patients ability to achieve the new more stringent LDL-C guideline targets,” said Dr. Evan Stein MD PhD, Chief Executive and Scientific Officer of LIB Therapeutics and continued. “The results are consistent with combined inhibition of circulating free PCSK9 from non-hepatic and reduced hepatic synthesis and provides an additional pathway to achieving treatment lipid goals in the many patients who cannot achieve them with current therapies. Significant additional studies are required to determine the optimal dosing frequency and safety of combining these therapies.”

About Lerodalcibep

Lerodalcibep is a novel, small protein-binding, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly, single small-volume, subcutaneous injection that will not require refrigeration at home or in travel. These features make Lerodalcibep a unique alternative to approved PCSK9 inhibitors. The anti-clockwise binding domain of Lerodalcibep is an 11-kDa polypeptide called an accenting, engineered for high-affinity subnanomolar binding to human PCSK9 and fused to human serum albumin to enhance plasma half-life.

In clinical trials, Lerodalcibep has demonstrated sustained LDL-C reductions of ≥60% in patients with, or at very-high or high risk of, cardiovascular disease (CVD) and ≥50% in those with heterozygous familial hypercholesterolemia (FH) who have more severe LDL-C elevations, and is expected to expand treatment options for the millions of patients around the world with CVD, including the 30 million individuals with VHF.

The global Phase 3 LIBerate program enrolled a diverse population of over 2,900 patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia. Lerodalcibep was dosed once monthly for up to 52 weeks in these key registration-enabling, placebo-controlled trials, and over 2,400 patients have continued in the 72-week open-label extension trial.

LIB submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) in December 2024, and received formal filing by FDA in February with an anticipated PDUFA date on target for mid December this year. LIB is seeking approval of Lerodalcibep (LEROCHOL®) as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Marketing Authorization Application was submitted to, and accepted by the European Medicines Agency in May with anticipated approval in June 2026.

About LIB Therapeutics Inc.

LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing Lerodalcibep to the millions of patients with cardiovascular disease and to the 30 million individuals with familial hypercholesterolemia (FH) around the world, who require additional large reductions in LDL-C, despite maximally tolerated stains and other lipid lowering agents, to achieve LDL-C goals.

For more information, please visit: www.libtherapeutics.com.

Contacts

Kate Caldwell

kcaldwell@libtherapeutics.com

U.S. Hemp Roundtable Strongly Opposes Proposed Senate Language to Recriminalize Hemp




U.S. Hemp Roundtable Strongly Opposes Proposed Senate Language to Recriminalize Hemp

WASHINGTON–(BUSINESS WIRE)–#HempHelps–The U.S. Hemp Roundtable issues the following statement regarding the proposed Senate language to recriminalize hemp products, condemning the harmful decision by Congress that threatens to eliminate America’s $28.4 billion hemp industry and jeopardizes more than 300,000 American jobs. If passed, this legislation would wipe out 95% of the industry, shuttering small businesses and American farms while costing states $1.5 billion in lost tax revenue.

Despite misleading claims this language protects non-intoxicating CBD products, the reality is that more than 90% of non-intoxicating hemp-derived products contain levels of THC that are greater than the proposed cap of .4 mg per container. As a result, seniors, veterans, and many other consumers who depend on hemp for their health and well-being would be violating federal law to purchase these products, disrupting their care and leaving them scrambling for potentially harmful alternatives.

While Congress pushes forward with this hemp-killing provision, the fight is far from over. Senator Rand Paul (R-KY) is submitting an emergency amendment to strike the hemp ban from the proposed legislation, a move fully supported by the hemp industry. His leadership offers a critical lifeline to thousands of American farmers, entrepreneurs, and consumers, and the industry stands united behind his efforts.

If the language passes, as-is, the hemp industry is committed to continuing the fight. During the one-year proposed moratorium, U.S. Hemp Roundtable will work closely with lawmakers to reverse the ban and replace it with responsible, science-based regulations that crackdown on misleading and purely synthetic products, create restrictions that keep products out of the hands of children, and promote standard manufacturing practices. Unlike these regulations, the current proposal fails to protect consumers and risks fueling a dangerous black market.

“Our industry is being used as a pawn as leaders work to reopen the government. Recriminalizing hemp will force American farms and businesses to close and disrupt the wellbeing of countless Americans who depend on hemp,” said Jonathan Miller, U.S. Hemp Roundtable General Counsel. “We support Senator Rand Paul’s efforts to push back on this language and will continue to fight alongside him for a regulated, safe, and robust hemp industry.”

# # #

About the U.S. Hemp Roundtable:

The U.S. Hemp Roundtable is a coalition of dozens of leading companies and organizations committed to safe hemp and CBD products. We proudly represent the industry’s major national grassroots organizations and are leading the way forward for hemp and CBD products through education and action.

Contacts

Media Contact
news@hempsupporter.com

Hepta Unveils First Multi-Omic Atlas of MASH, Linking Liver Pathway Biology to cfDNA Methylation in Blood




Hepta Unveils First Multi-Omic Atlas of MASH, Linking Liver Pathway Biology to cfDNA Methylation in Blood

Hepta’s liquid biopsy-native AI model links coordinated methylation and gene expression changes to fibrosis progression, showing that liver biology can be measured non-invasively from blood

FOSTER CITY, Calif.–(BUSINESS WIRE)–Hepta, a biotechnology company using transformer-based AI to decode the cell-free DNA (cfDNA) epigenome and detect organ-specific signals of chronic disease, today announced the creation of an unparalleled multi-omic atlas of metabolic dysfunction–associated steatohepatitis (MASH) in collaboration with Duke University. This work builds on Hepta’s expanded cfDNA studies with Mainz University and Akero Therapeutics’ Phase 3 clinical trial program, further strengthening the company’s partnerships across academic and clinical research.

The atlas integrates single-cell and bulk data across hundreds of liver samples, including gene expression, chromatin accessibility, and DNA methylation, paired with cfDNA methylation from matched blood plasma. Presented this week at AASLD’s The Liver Meeting, the atlas reveals how coordinated methylation and transcriptional programs drive inflammation and fibrosis and demonstrates that these same molecular signals are detectable in blood using Hepta’s liquid biopsy-native AI platform.

“In liver tissue, we observe pathway activity, gene expression, and cell type composition that are mediated by methylation across disease severity,” said Anna Mae Diehl, M.D., Florence McAlister Distinguished Professor of Medicine at Duke University. “Critically, those same signatures are measurable in plasma cfDNA, indicating that cfDNA methylation can serve as a faithful mirror of liver biology. That concordance supports cfDNA methylation as a plausible, non-invasive readout of pathway activities in liver disease, offering insights far deeper than traditional biomarkers.”

The MASH atlas maps how methylation governs pathway-level activity across hepatocytes, cholangiocytes, and stromal cells in the liver. The analysis shows the role of methylation in a broad dysregulation of metabolic, inflammatory, fibrogenic, and bile-acid pathways that track with fibrosis severity, including mechanisms targeted by emerging therapeutic classes such as GLP-1, FGF-21, and THR-β agonists. The MASH atlas also demonstrates that the same pathway signatures observed in liver tissue are reproducibly detectable in cfDNA circulating in blood, creating a molecular bridge between liver-tissue biology and liquid-biopsy measurement.

This foundational work, in addition to Hepta’s expanded cfDNA results spanning across multiple independent cohorts — including Duke University, Mainz University, and Akero Therapeutics’ phase 3 clinical trial program — was featured in Dr. Jörn Schattenberg’s presentation at the Precision Liver Symposium.

“Across independent cohorts, we see strong, consistent diagnostic performance from Hepta’s cfDNA methylation platform,” said Jörn Schattenberg, M.D., Director of the Metabolic Liver Research Center at Saarland University. “What’s striking is that the same readout also delivers deep biological insights. It’s not just a yes-or-no test; these signals reveal how repair and fibrosis programs evolve, which opens the door to earlier intervention and therapy guidance.”

Hepta’s transformer-based, liquid biopsy–native AI was specifically designed to resolve the complexity of cfDNA. The model interprets billions of cfDNA fragments in context, detecting subtle, distributed patterns that correspond to tissue-level changes. By decoding the entire cfDNA epigenetic landscape, the platform enables tissue-level biological interpretation from a standard blood draw.

While traditional panel biomarkers infer fibrosis indirectly, cfDNA methylation directly reads the gene-regulatory programs driving those changes. Together with the multi-omic atlas, these data represent the largest multi-cohort validation to date of cfDNA methylation as a biomarker in MASH and demonstrate how deep multi-omics can inform clinical translation.

“Our data demonstrate that cfDNA captures the molecular fingerprint of disrupted repair,” said Hamed Amini, Ph.D., Co-founder and CEO of Hepta. “The atlas establishes the biological foundation for our technology, showing that the same pathways we observe in tissue are encoded in blood. This work lays a foundation for biology-driven detection and for future therapeutic strategies that address the mechanisms behind liver damage and fibrosis.”

Hepta’s approach extends the frontier of liquid biopsy beyond oncology, positioning cfDNA methylation as a scalable molecular window into chronic disease biology and, potentially, a snapshot of full body health. The company is expanding its clinical studies to further validate cfDNA-based biomarkers for early detection, informing treatment strategies, and longitudinal monitoring across the care continuum.

About Hepta

Hepta detects chronic disease early by using cfDNA epigenetic analysis and AI to deliver accurate, non-invasive diagnostics at population scale. Founded by former Illumina, Grail and Google scientists, the company is backed by Felicis Ventures, Illumina Ventures, and SeaX Ventures. Hepta is proving that blood-based epigenetic biomarkers can replace invasive biopsies, enabling earlier and more accessible detection of diseases like MASH and laying the foundation for future applications across chronic diseases. For more information, visit www.hepta.bio.

Contacts

Media Contact
Patrick Schmidt

Consort Partners for Hepta

pr@hepta.bio

Medincell to Join MSCI World Small Cap Index, a Leading Global Benchmark




Medincell to Join MSCI World Small Cap Index, a Leading Global Benchmark

MONTPELLIER, France–(BUSINESS WIRE)–Medincell has been selected for inclusion in the Morgan Stanley Capital International (MSCI) World Small Cap Index, which encompasses the most liquid and high-performing small-cap companies across 23 developed markets.

Joining the MSCI World Small Cap Index reflects the strength of Medincell’s business model, its growth potential, and its commitment to innovation and social responsibility.

The inclusion will enhance Medincell’s visibility among institutional investors and index-tracking funds that follow MSCI indices.

The entry will become effective at the opening of trading on 24 November 2025.

About the MSCI World Small Cap Index

• The MSCI World Small Cap Index captures small-cap representation across 23 developed market countries. With approximately 3,840 constituents, the index covers about 14% of the free float-adjusted market capitalization in each country.
• For more information: https://www.msci.com/documents/10199/255599/msci-world-small-cap-index.pdf

About Medincell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable treatments across multiple therapeutic areas. Our innovative treatments are designed to ensure adherence to medical prescriptions, enhance the effectiveness and accessibility of medicines, and reduce their environmental impact.

These treatments combine active pharmaceutical ingredients with our proprietary BEPO^® technology, which enables controlled drug delivery at therapeutic levels for several days, weeks, or months following a subcutaneous or local injection of a small, fully bioresorbable deposit.

The first treatment based on BEPO^® technology was approved for schizophrenia by the FDA in April 2023 and is now marketed in the United States by Teva under the name UZEDY^® (BEPO^® technology is licensed to Teva under the name SteadyTeq™).

Our investigational pipeline includes numerous innovative therapeutic candidates in various stages of development, from formulation to Phase 3 clinical trials. We collaborate with leading pharmaceutical companies and foundations to advance global health through new treatment options.

Headquartered in Montpellier, France, Medincell employs over 140 people representing more than 25 nationalities.

UZEDY^® and SteadyTeq™ are trademarks of Teva Pharmaceuticals.

www.medincell.com

Contacts

David Heuzé
Head of Corporate and Financial Communications, and ESG

david.heuze@Medincell.com / +33 (0)6 83 25 21 86

Grace Kim
Chief Strategy Officer, U.S. Finance

grace.kim@medincell.com / +1 (646) 991-4023

Nicolas Mérigeau / Arthur Rouillé
Media Relations

Medincell@newcap.eu / +33 (0)1 44 71 94 94

Louis-Victor Delouvrier / Alban Dufumier
Investor Relations France

Medincell@newcap.eu / +33 (0)1 44 71 94 94

Elevance Health Foundation Invites Applications for $5 Million Patient Safety Prize Through New Community Action Leadership Initiative




Elevance Health Foundation Invites Applications for $5 Million Patient Safety Prize Through New Community Action Leadership Initiative

Applications open December 9 for innovative solutions to improve patient safety in three key areas: medication safety, fall prevention, and health literacy.

INDIANAPOLIS–(BUSINESS WIRE)–Elevance Health Foundation today announced that applications will open December 9, 2025, for its inaugural $5 million Patient Safety Prize. With a focus on improving health literacy, eliminating medication errors, and preventing patient falls, the Prize invites changemakers to submit transformational solutions that improve safety, advance quality of care, and enhance outcomes for vulnerable populations.

As part of the Community Action Leadership (CAL) initiative, the inaugural Patient Safety Prize advances the Foundation’s mission to drive community-based innovation that addresses critical health challenges. Unlike traditional grantmaking, this unique take on philanthropy will cultivate collaboration among external thought leaders while continuing to cement the Foundation’s role as a catalyst for positive change in the community.

A diverse array of nonprofits, healthcare institutions, technology companies, patient advocacy groups, and thought leaders are encouraged to apply for a share of the $5 million prize pool, which will recognize and accelerate their initiatives.

“Patient safety is one of the most pressing challenges facing our healthcare system today. Too often, preventable harm impacts already disadvantaged communities,” said Shantanu Agrawal, M.D., Chief Health Officer, Elevance Health. “Through the Community Action Leadership Patient Safety Prize initiative, we are creating a platform for bold, innovative solutions that can reduce harm, improve outcomes, and make healthcare safer, more accessible, and more responsive to the needs of every patient. We look forward to seeing the transformational solutions that emerge from this inaugural challenge.”

Patient safety events disproportionately impact socially vulnerable communities and are often preventable. The Centers for Disease Control and Prevention (CDC) reports that more than 1.5 million Americans visit emergency departments each year due to adverse drug events, while the Agency for Healthcare Research and Quality (AHRQ) estimates 700,000 to 1 million patient falls occur in U.S. hospitals annually. The Center for Health Care Strategies (CHCS) also finds that nearly nine in ten adults struggle with health literacy, increasing the risk of preventable harm.

The Patient Safety Prize initiative was announced at the National Academy of Medicine (NAM)’s November Meeting, “The Future of Patient Safety: A New Paradigm.” With support from the NAM, Elevance Health Foundation will be convening a distinguished panel of experts to evaluate Prize submissions. Building on the foundation of the NAM’s landmark work, including “To Err is Human,” the Foundation aims to advance innovative, evidence-based solutions that expand access to safer, higher-quality care and improve health care experiences for all communities.

To learn more about the Patient Safety Prize and access the RFP when it goes live on December 9, 2025, please visit www.patientsafetyprize.org. Applicants must complete their registration by March 17, 2026, and submit their proposal by April 7, 2026, to be considered.

About Elevance Health Foundation

Elevance Health Foundation is the philanthropic arm of Elevance Health Inc. The Foundation works to improve the health of the socially vulnerable through partnerships and programs in our communities with an emphasis on maternal-infant health; behavioral health; and food as medicine. Through its key areas of focus, the Foundation also strategically aligns with Elevance Health’s focus on community health and becoming a lifetime, trusted health partner that is fueled by its purpose to improve the health of humanity. To learn more about Elevance Health Foundation, please visit www.elevancehealth.foundation or follow us @ElevanceFND on X and Elevance Health Foundation on Facebook.

Contacts

Media Contact
Shelby Kaiser

Elevance Health Foundation

shelby.kaiser@elevancehealth.com

Abselion Launches His-tagged Protein Quantification Kit and Sensors for Amperia at PEGS Europe 2025




Abselion Launches His-tagged Protein Quantification Kit and Sensors for Amperia at PEGS Europe 2025

• Ready-to-use solution, developed in collaboration with GenScript, offers rapid and reliable quantification of His-tagged proteins
• Broadens Amperia’s applications across recombinant protein research, screening, and development
• Abselion to showcase kit alongside Amperia platform at PEGS Europe in Lisbon, Portugal from 11–13 November

CAMBRIDGE, England–(BUSINESS WIRE)–#Abselion–Abselion, a pioneering life sciences technology company focused on simplifying biomolecule quantification, has expanded its Amperia™ assay portfolio with the launch of its Tagged Protein Quantification Kit | His-tag and Tagged Protein Sensor | His-tag Quantification. The novel assay, developed with GenScript’s THE™ His Tag Monoclonal Antibodies, provides researchers with a ready-to-use solution for rapid, reliable measurement of His-tagged proteins. This launch marks a significant milestone in extending Amperia, beyond antibody and AAV assays, into the wider field of recombinant protein analysis, enabling researchers to generate high-quality data more quickly and dependably across expression, optimisation, and development workflows.

His-tags are among the most widely used affinity tags, supporting purification and detection of recombinant proteins expressed in bacterial, insect, and mammalian systems. Quantification often involves ELISA, gels, or spectrophotometric methods, which can be time-consuming, variable, or less effective, particularly when working with crude samples. Abselion’s Tagged Protein Quantification Kit provides a fast, reproducible, and ready-to-use alternative for drug discovery, structural biology, therapeutic research, and bioprocess development workflows.

Abselion’s Amperia benchtop platform is a simple-to-use solution that uses redox electrochemical detection for rapid and accurate automated quantification of a range of biomolecules, without optics or fluidics. The new assay runs in a premix competition format, within Amperia’s intuitive, software-controlled workflow, to quantify His-tagged proteins directly from crude or purified samples without specialist training.

Each kit includes pre-coated sensor strips, together with assay plates, detection reagents, and buffers in a complete, ready-to-use package. At the core of the new kit are electrochemical sensor strips pre-coated with GenScript’s validated antibodies, immobilised on the sensor surface. These high affinity antibodies offer broad reactivity across common His-tag variants and expression systems for enhanced assay robustness. Incorporating these directly onto the strip reduces manual handling steps and the need for additional assay development or optimisation, improving usability and supporting more consistent performance.

In parallel to the complete Tagged Protein Quantification Kit | His-tag for guided, automated workflows, Abselion has also launched the Tagged Protein Sensor | His-tag Quantification as a standalone consumable pack. This provides direct access to the antibody-coated sensor strips, offering additional flexibility for a wide range of His-tag assays on the Amperia platform.

Dr Ruizhi Wang, CEO and Founder, Abselion, said: “The His-tag launch is one of the first affinity-based, electrochemical, automated kits for crude samples and marks an important step in extending Amperia into one of the most widely used areas of protein science. By combining GenScript’s trusted antibody technology with our ready-to-use design, we are giving researchers faster, more dependable ways to quantify His-tagged proteins directly from complex samples. Together with the flexibility of a standalone sensor option, this reflects Abselion’s mission to make high-quality protein quantification more practical and accessible to meet the needs of scientists across research, development and bioprocessing.”

Higgins Qin, Senior Director, Protein & Antibody R&D, GenScript, added: “Our THE His Tag Monoclonal Antibodies are recognised for their high affinity and broad applicability across recombinant protein workflows. Incorporating these into Abselion’s Amperia system provides researchers with a solution that simplifies His-tag quantification and supports consistent measurement from crude through to purified samples. We are pleased to see GenScript’s trusted antibody technology applied in an innovative format that makes protein analysis more reliable and accessible.”

For further information about Abselion’s Tagged Protein Quantification Kit | His-tag and Tagged Protein Sensor | His-tag, please visit: https://www.abselion.com/assay-kits and https://www.abselion.com/sensors/. To download the application notes “Enabling His-tagged Protein Analysis in Expression Workflows” and “Use Case: His-tag Protein Expression Screening from Crude Lysates” or case study “VIB Nanobody Core validates Amperia™ for rapid his-tag nanobody quantification”, please visit: https://www.abselion.com/resources/.

Meet the Abselion team at PEGS Europe from 11–13 November in Lisbon, Portugal (Booth #416) to learn more.

Please contact Codon Communications for high-resolution images.

Contacts

Codon Communications
Dr Michelle Ricketts

Tel: +44 7789 053885

Email: michelle.ricketts@codoncommunications.com

Vir Biotechnology Announces AASLD The Liver Meeting® Presentation & New England Journal of Medicine Publication of Phase 2 Data Demonstrating Tobevibart & Elebsiran Combination Deliver High Rates of Undetectable HDV RNA with Favorable Safety Profile




Vir Biotechnology Announces AASLD The Liver Meeting® Presentation & New England Journal of Medicine Publication of Phase 2 Data Demonstrating Tobevibart & Elebsiran Combination Deliver High Rates of Undetectable HDV RNA with Favorable Safety Profile

• SOLSTICE trial data demonstrate that 66% of chronic hepatitis delta participants receiving a monthly dose of tobevibart and elebsiran achieved undetectable HDV RNA at Week 48
• Combination well-tolerated: No grade 3 or higher treatment-related adverse events and no treatment-related discontinuations
• ECLIPSE registrational program evaluating the combination of tobevibart and elebsiran for chronic hepatitis delta fully underway, with topline data expected in the first quarter of 2027
• Data presented at AASLD The Liver Meeting® and simultaneously published in the New England Journal of Medicine

SAN FRANCISCO–(BUSINESS WIRE)–Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that Week 48 endpoint analysis from the Company’s Phase 2 SOLSTICE trial for chronic hepatitis delta (CHD) demonstrated that participants receiving a monthly dose of the combination of tobevibart and elebsiran achieved robust and sustained rates of hepatitis delta virus (HDV) RNA target not detected (TND), including those participants with cirrhosis and high baseline HDV RNA. The combination also showed alanine aminotransferase (ALT) reductions over time and a favorable safety profile. These data were presented in an oral session at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting ^®, in Washington, D.C., and simultaneously published in the New England Journal of Medicine.

“Achieving undetectable HDV RNA is a key endpoint in clinical trials, and HDV RNA undetectability is associated with better outcomes for people living with chronic hepatitis delta,” said Tarik Asselah, M.D., Ph.D., Professor of Hepatology at the Hôpital Beaujon, APHP, Clichy, France, and at the University of Paris-Cité, and Head of the unit Viral Hepatitis UMR1149 at INSERM, France. “The combination of tobevibart and elebsiran has consistently demonstrated impressive hepatitis delta virologic suppression in the SOLSTICE Phase 2 trial, and these 48-week data are encouraging as they continue to support its potential to deliver meaningful patient benefit.”

Data demonstrate that 66% (21/32) of participants with CHD receiving a monthly dose of the combination of tobevibart and elebsiran achieved and sustained HDV RNA TND at 48 weeks. Additionally, approximately 90% of participants achieved reduction in hepatitis B surface antigen (HBsAg) to values <10 IU/mL by Week 48. HBsAg reduction indicates suppression of the fundamental biologic mechanisms that HDV requires for viral replication. ALT was normalized in 56% (18/32) of participants by Week 48. The combination was well-tolerated, with no grade 3 or higher treatment-related adverse events and no treatment-related discontinuations. Most treatment-related adverse events were generally mild to moderate and transient.

The combination of tobevibart and elebsiran is currently being evaluated in Vir Biotechnology’s ECLIPSE registrational program for the treatment of CHD, which includes three randomized, controlled trials. ECLIPSE 1 has completed enrollment ahead of the Company’s expectations. Topline results from ECLIPSE 1, 2, and 3 are expected in the first quarter of 2027.

“The 48-week data from the SOLSTICE Phase 2 trial presented at AASLD’s The Liver Meeting® reinforce our confidence that a monthly dose of the combination of tobevibart and elebsiran can deliver meaningful patient benefit with convenient dosing, and I am proud to see the caliber of our data recognized by our publication in the prestigious New England Journal of Medicine,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “We are committed to advancing our registrational ECLIPSE program efficiently with the goal of addressing the critical unmet needs of the hepatitis delta community.”

CHD is the most severe form of chronic viral hepatitis,¹ recently classified as carcinogenic by the International Agency for Research on Cancer.² People living with the disease rapidly progress to cirrhosis, liver failure³ and liver-related death.¹ There are currently no approved treatments in the U.S., and options are limited in the European Union and globally. The objective is to eliminate the virus, and tobevibart in combination with elebsiran offers the potential to achieve this by tackling the viral lifecycle through multiple mechanisms.

The significant unmet need in CHD and the potential for the combination of tobevibart and elebsiran to provide a much-needed treatment option has been recognized by the U.S. Food and Drug Administration (FDA) with Breakthrough Therapy and Fast Track designations, and by the European Medicines Agency (EMA) with Priority Medicines (PRIME) and orphan drug designations.

About the ECLIPSE Registrational Program

ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 (NCT06903338) is a Phase 3 trial evaluating the safety and efficacy of tobevibart in combination with elebsiran compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 (NCT07128550) is a Phase 3 trial that will evaluate the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 (NCT07142811) is a Phase 2b head-to-head trial to evaluate tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets.

About Tobevibart and Elebsiran

Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.

About Vir Biotechnology, Inc.

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website.

References:

¹ NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis D – NIDDK (nih.gov), accessed September 2025

² Karagas, Margaret R et al., Carcinogenicity of hepatitis D virus, human cytomegalovirus, and Merkel cell polyomavirus, The Lancet Oncology, Volume 26, Issue 8, 994 – 995.

³ CDC What is Hepatitis D – FAQ | CDC, accessed September 2025

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of the combination of tobevibart and elebsiran to treat CHD and Vir Biotechnology’s belief that monthly dosing of the combination can deliver meaningful patient benefit and address the critical unmet needs of the hepatitis delta community; Vir Biotechnology’s clinical development plans and expectations for the ECLIPSE Phase 3 registrational program, including protocols for and enrollment into ongoing and planned clinical trials, target endpoints and data readouts (including the expectation of topline data for all three trials in the first quarter of 2027); Vir Biotechnology’s strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology’s planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology’s competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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Virion Therapeutics Reports Progress Towards HBV Functional Cure with Sustained and Continued HBsAg Declines up to One Year After a Single VRON-0200 Dose From its Phase 1b Study at AASLD’s The Liver Meeting® 2025




Virion Therapeutics Reports Progress Towards HBV Functional Cure with Sustained and Continued HBsAg Declines up to One Year After a Single VRON-0200 Dose From its Phase 1b Study at AASLD’s The Liver Meeting® 2025

Highlights from the Data Presentation

• VRON-0200 was safe and well tolerated, with no serious treatment-related adverse events, treatment discontinuations, or treatment-related clinical laboratory abnormalities reported
• In the majority of patients (83%; 19/23), a single intramuscular VRON-0200 dose, added to standard of care antiviral therapy, induced anti-HBV immune activation and restoration, with HBsAg declines beginning at Day 28; these HBsAg declines were sustained and/or continued to decline up to one year after VRON-0200 treatment, with 47% of patients (9/19) achieving greater than a 50% reduction (4 patients had a 1 log₁₀ IU/mL or greater decline) at Day 360
• A single VRON-0200 prime dose, followed by the addition of monthly doses of investigational antivirals initiated 28 days later, produced rapid and profound HBsAg declines (<2 IU/mL) in all patients (n=7); at Week 20, three of six patients achieved complete HBsAg loss, one within 7 days of the first combination dose
• The “Spark and Fan” model where an upfront VRON-0200 “spark” dose “primes” an anti-HBV immune response which is then “fanned” (aka boosted) by an antiviral regimen that removes the virus (e.g., HBsAg), could make VRON-0200 the foundational backbone agent to a wide range of future Functional Cure treatments

PHILADELPHIA–(BUSINESS WIRE)–Virion Therapeutics, LLC, a clinical-stage biotechnology company, developing novel T cell-based immunotherapies that utilize checkpoint modifiers, today announced at AASLD’s The Liver Meeting^®, in Washington DC, that a single intramuscular dose of VRON-0200, its novel, first-in-class, immunotherapy for HBV Functional Cure, induced HBV-specific immune activation, restoration, and HBsAg declines, that were sustained and/or continued up to one-year post dosing, in the majority of chronically HBV-infected treated patients. The data, presented as an oral presentation, by Dr. Grace Wong, M.D., from the Chinese University of Hong Kong, also highlighted VRON-0200’s ongoing favorable safety and tolerability profile, and rapid and profound HBsAg declines when VRON-0200 was combined with an investigational antiviral regimen.

Professor Grace Wong, M.D., from the Chinese University of Hong Kong, and one of the study investigators commented: “Current and investigational HBV Functional Cure treatments have been limited by their inability to restore a patient’s own immune responses against the virus. As a result, once treatment is discontinued, and the antiviral agents are no longer present, viral rebound typically occurs. What makes these data so exciting is that not only was a single, well tolerated VRON-0200 dose, alone, able to restore broad anti-HBV immune responses in the majority of chronically HBV-infected patients, but these responses were sustained, and/or improved, up to one year after end of treatment. VRON-0200’s ability to restore a patient’s own anti-HBV responses, with the potential for sustained viral control after antiviral treatment ends, is a significant advance for the field and opens up a wide range of possible future Functional Cure treatment options.”

“These new VRON-0200 clinical study data highlight its potential as a key component in future HBV Functional Cure regimens,” said Dr. Sue Currie, COO of Virion, and one of the study authors. “Off treatment viral rebound has been the “Achilles heel” for every HBV Functional Cure regimen to date. A single VRON-0200 dose alone was able to “Spark” a new and sustained anti-HBV response that could offer a solution to treatment rebound. This novel and exciting approach, where a patient’s own immune response is “sparked” (i.e. primed) with VRON-0200, and then “fanned” (aka boosted) by the removal of the HBV virus, position VRON-0200 to be the foundational backbone agent for new combination therapies that could produce meaningful Functional Cure rates for the almost 260 million persons living with chronic HBV worldwide. A Phase 2b SPARK-B trial for HBV Functional Cure is in development and will use the “Spark and Fan” approach to evaluate VRON-0200 in combination with an investigational antiviral.”

Professor Ed Gane, M.D., from the University of Auckland, and one of the study investigators, noted: “Sustained viral control after finite treatment is difficult to achieve with current HBV Functional Cure regimens, including those containing pegylated interferon. What is particularly exciting about these VRON-0200 data are that, in the majority of patients, most infected at birth, VRON-0200 was not only able to activate and restore an HBV-specific immune response, but also, these HBsAg responses were sustained and further reduced even one year after end of VRON-0200 dosing. These sustained anti-HBV immune responses, after finite treatment, could provide a solution for long-term prevention of viral rebound and ultimately get us closer to meaningful Functional Cure rates.”

The presentation is available for download at www.VirionTx.com and more details of this study can be found at ClinicalTrials.gov (Identifier: NCT06070051).

About Chronic Hepatitis B

Despite a preventative vaccine, cases of chronic hepatitis B (CHB) continue to rise, with an estimated 254 million persons infected worldwide and 1.1 million deaths per year from HBV-related liver complications. Chronic HBV remains a global health issue with a high unmet medical need, since there is no cure available. The current standard of care requires lifelong antiviral therapy to maintain control of the virus.

About VRON-0200

VRON-0200 is an investigational therapeutic immunotherapy designed with the goal of providing a functional cure for chronic HBV infection. Clinical data from an ongoing Phase 1b trial have shown VRON-0200 to be safe and well tolerated, and, when given as a single intramuscular dose, was immunogenic, and able to “Spark” anti-HBV activity in chronically HBV-infected patients on nucleos(t)ide therapy alone, and, also, when administered first and given with combination antiviral therapies. These results suggest the potential of VRON-0200 to be the key backbone agent, in combination HBV functional cure regimens.

About Virion Therapeutics (Virion)

Virion Therapeutics, LLC is a clinical-stage company developing novel immunotherapies that utilize proprietary checkpoint modifiers to enhance/restore, broaden, and elicit sustained immune responses, with the goal to cure cancer and chronic infectious diseases. Virion has since developed a robust pipeline, including its lead VRON-0200 clinical program, and several additional IND-enabling programs, such as its VRON-0300 oncology program for advanced solid tumors, leveraging its proprietary platform technologies.

To learn more, visit www.VirionTx.com

Contacts

Virion Therapeutics, LLC, Dr. Sue Currie, Chief Operating Officer

scurrie@viriontx.com
1-800-841-9303