Cellectar Biosciences to Report Full Year Financial Results and Host a Conference Call on Wednesday, March 4, 2026




Cellectar Biosciences to Report Full Year Financial Results and Host a Conference Call on Wednesday, March 4, 2026

FLORHAM PARK, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the Company will report financial results for the full year ended December 31, 2025, and provide a corporate update on March 4, 2026, at 8:30 a.m. Eastern Time.

A replay of the corporate presentation will be available on the Events section of the Company’s Investor Relations website.

About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical radiopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments that deliver improved efficacy and better safety.

The company’s product pipeline includes its lead assets: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope) for the treatment of hematologic and solid tumor cancers such as Waldenstrom’s macroglobulinemia (WM) and pediatric high grade gliomas; CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeting solid tumors, such as triple negative breast, lung and colorectal cancers; CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors with significant unmet need, such as pancreatic cancer; and proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.

Iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory WM and multiple myeloma (MM), non-Hodgkin’s lymphomas and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough Therapy, six Orphan Drug, five Rare Pediatric Drug and two Fast Track Designations for various cancer indications. The European Medicines Agency (EMA) has also granted iopofosine I 131 PRIME and orphan drug designations for the treatment of WM.

For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook.

Investor Contact:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com

Rivus Pharmaceuticals Appoints Jorge Bartolome as Chief Executive Officer




Rivus Pharmaceuticals Appoints Jorge Bartolome as Chief Executive Officer

Pharmaceutical veteran with extensive late-stage development and commercial experience to lead Rivus as it advances its pipeline of oral medicines that leverage energy expenditure for the treatment of MASH, obesity, and associated cardiometabolic diseases

CHARLOTTESVILLE, Va. and SOUTH SAN FRANCISCO, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) — Rivus Pharmaceuticals Inc., a clinical-stage biopharmaceutical company dedicated to treating MASH, obesity, and associated cardiometabolic diseases, today announced the appointment of Jorge Bartolome as Chief Executive Officer and member of the Board. He succeeds Allen Cunningham, a co-founder who will move to the role of Chief Operating Officer.

Mr. Bartolome has over 25 years of leadership experience in the pharmaceutical and biotechnology industry. With a proven track record of building high-performing organizations, he brings extensive leadership experience in late-stage clinical development, commercial launch, and sales and marketing. Before joining Rivus, he served as Chief Executive Officer and Director of AreteiaTx and earlier served as President of Janssen Canada (Johnson & Johnson) and held increasingly senior positions over 20 years at GSK.

“Rivus is embarking on an important stage of its journey as the company advances two potentially transformative oral medicines targeting MASH, obesity, and associated cardiometabolic diseases,” said Ian F. Smith, Co-Chair of the Board of Rivus Pharmaceuticals. “Jorge’s extensive pharmaceutical background in late-stage drug development and commercialization makes him the ideal leader for Rivus to navigate the unprecedented opportunity to treat MASH, obesity, and its co-morbidities. It is an exciting time at Rivus, a company on the forefront of the next era for obesity treatments, focused on energy expenditure and preservation of muscle for sustained metabolic health.”

“I am honored to lead this talented team as we drive Rivus forward as a company with multiple oral therapies to address the growing unmet patient needs in MASH, obesity, and associated cardiometabolic diseases,” said Jorge Bartolome, Chief Executive Officer and Director, Rivus Pharmaceuticals. “Rivus has made remarkable progress developing a best-in-class oral mitochondrial uncoupler HU6 through three Phase 2 trials that achieved their primary endpoints and demonstrated a favorable safety and tolerability profile. 2026 will be a pivotal year for Rivus as we advance HU6 in the AMPLIFY Phase 2 trial in MASH and prepare for our first clinical trial for RV-8451, our differentiated oral, muscle-preserving GLP-1, in obesity.”

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c999693b-65d5-4e13-9622-8175bc2f813a

Jorge Bartolome has over 25 years of leadership experience in the pharmaceutical and biotechnology industry. With a proven track record building high-performing organizations, he brings extensive leadership experience in late-stage clinical development, commercial launch, and sales and marketing. Previously, he served as Chief Executive Officer and Director of AreteiaTx, leading the company through positive Phase 3 trial data for a first-in-class oral therapy for asthma and COPD. Earlier, he served as President of Janssen Canada (Johnson & Johnson) after serving as Vice President, Cardiovascular business in the U.S. Mr. Bartolome began his career at GSK, serving in positions of increasing responsibility for over 20 years across North America, Asia, and Latin America, ultimately serving as Senior Vice President, Business Unit Leader in the U.S. for multiple therapeutic areas generating $8 billion in annual sales. He earned a B.A. in Economics from Duke University.

About Rivus Pharmaceuticals
Rivus Pharmaceuticals, Inc. is a clinical-stage biotechnology company advancing new oral investigational medicines for MASH (metabolic dysfunction-associated steatohepatitis), obesity, and associated cardiometabolic diseases. Rivus is developing oral small molecule therapeutics that are designed to increase energy expenditure for sustained, fat-selective, muscle-preserving weight loss. These medicines leverage validated mechanisms, including mitochondrial uncoupling and GLP-1 agonism, to address the limitations of current treatments for these chronic diseases that need new chronic treatment options. Rivus’ lead candidate HU6 is a potential best-in-class oral mitochondrial uncoupler that has demonstrated positive results in three Phase 2 clinical trials. In addition, Rivus has a research and discovery platform and is developing a pipeline of preclinical therapies, including RV-8451, a differentiated oral muscle-preserving GLP-1, for obesity. Follow Rivus on LinkedIn and X and visit www.rivuspharma.com.

CONTACT: Company Contact: 
Amy Figueroa, CFA
Rivus Pharmaceuticals
afigueroa@rivuspharma.com

Media Contact:
Matt Wright
Real Chemistry
mwright@realchemistry.com

Prime Medicine to Participate in Upcoming Investor Conferences




Prime Medicine to Participate in Upcoming Investor Conferences

CAMBRIDGE, Mass., Feb. 25, 2026 (GLOBE NEWSWIRE) — Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced that company management will participate in three upcoming conferences:

• TD Cowen 46^th Annual Health Care Conference: Fireside chat on Wednesday, March 4, 2026, at 1:10 p.m. ET in Boston, MA.
• 2026 Jefferies Biotech on the Beach Summit: Company management will host 1×1 meetings on Tuesday, March 10, 2026, in Miami Beach, FL.
• The Citizens Life Sciences Conference: Fireside chat on Wednesday, March 11, 2026, at 2:15 p.m. ET in Miami Beach, FL.

Live audio webcasts of the fireside chats will be available under “Events & Presentations” in the News & Events section of the Company’s website at www.primemedicine.com. Replays of each webcast will be available on the Prime Medicine website for 90 days following the event.

About Prime Medicine

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is deploying its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated one-time curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Taken together, Prime Editing’s versatile gene editing capabilities could unlock opportunities across thousands of potential indications.

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: liver, lung, and immunology and oncology. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. Over time, the Company intends to maximize Prime Editing’s broad and versatile therapeutic potential, as well as the modularity of the Prime Editing platform, to rapidly and efficiently expand beyond the diseases in its current pipeline, potentially including additional genetic diseases, immunological diseases, cancers, infectious diseases, and targeting genetic risk factors in common diseases, which collectively impact millions of people. For more information, please visit www.primemedicine.com.

© 2026 Prime Medicine, Inc. All rights reserved. PRIME MEDICINE, the Prime Medicine logos, and PASSIGE are trademarks of Prime Medicine, Inc. All other trademarks referred to herein are the property of their respective owners.

Investor and Media Contacts

Gregory Dearborn
Prime Medicine
857-209-0696
gdearborn@primemedicine.com 

Hannah Deresiewicz
Precision AQ
212-362-1200
hannah.deresiewicz@precisionaq.com

BrainsWay to Report Fourth Quarter and Full Year 2025 Financial Results on March 11, 2026




BrainsWay to Report Fourth Quarter and Full Year 2025 Financial Results on March 11, 2026

BURLINGTON, Mass. and JERUSALEM, Feb. 25, 2026 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation technologies, today announced that it will report its fourth quarter and full year 2025 financial results, as well as operational highlights, before the open of the U.S. financial markets on Wednesday, March 11, 2026. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

Conference Call Dial-In & Webcast Information

The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, https://investors.brainsway.com/events-and-presentations/event-calendar. Please access the Company’s website at least 10 minutes ahead of the conference call to register.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

Contacts:
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com

Investors:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com

Grace Therapeutics to Participate in the TD Cowen 46th Annual Health Care Conference




Grace Therapeutics to Participate in the TD Cowen 46th Annual Health Care Conference

PRINCETON, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) — Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that Chief Executive Officer Prashant Kohli will participate and present in TD Cowen’s 46^th Annual Health Care Conference, to be held March 2-4, 2026 in Boston, MA.

Mr. Kohli’s presentation is schedule for March 4, 2026 at 10:30 AM Eastern Time. To register for the webcast, click here. An archived replay will be available for 90 days following the event.

In addition, Mr. Kohli will participate in one-on-one and group investor meetings.

About aneurysmal Subarachnoid Hemorrhage (aSAH)

aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm in the brain. The result is a relatively uncommon type of stroke (aSAH) that accounts for about 5% of all strokes and an estimated 42,500 U.S. hospital treated patients.

About GTx-104

GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for IV infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.

About Grace Therapeutics

Grace Therapeutics, Inc. (Grace Therapeutics or the Company) is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’ novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutic’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States if certain conditions are met at NDA approval, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’ lead clinical asset, GTx-104, is an IV infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull.

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

For more information, please contact:

Grace Therapeutics Contact:

Prashant Kohli
Chief Executive Officer
Tel: 609-322-1602
Email: info@gracetx.com
www.gracetx.com

Investor Relations:

LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com

Novo Nordisk and Vivtex partner to develop next-generation oral medicines for obesity and diabetes




Novo Nordisk and Vivtex partner to develop next-generation oral medicines for obesity and diabetes

• Partnership will leverage Vivtex’s proprietary technologies built to identify optimal oral formulations for peptide and protein therapeutics with improved bioavailability
• Novo Nordisk will lead global development and commercialization, and Vivtex is eligible to receive up to 2.1 billion US dollars, as well as royalties on net sales of future products
• Partnership expands Vivtex’s platform to metabolic diseases and supports Novo Nordisk’s mission to deliver scalable and innovative medicines to people with obesity and diabetes

Bagsværd, Denmark and Boston, MA, US, 25 February 2026 – Novo Nordisk and Vivtex Corporation today announced a partnership to develop next-generation oral biologic medicines for obesity, diabetes and associated comorbidities.

Under the agreement, Vivtex will license select oral drug-delivery technologies to Novo Nordisk, while Vivtex is eligible to receive upfront consideration, research funding and milestone payments totalling up to 2.1 billion US dollars, and tiered royalties on future product sales.

“Novo Nordisk has been at the forefront of innovation in protein and peptide engineering for several decades, and not least within oral formulation of peptides. We launched the first-ever oral biologic more than five years ago and have recently launched the world’s first oral biologic for obesity,” said Brian Vandahl, senior vice president, Therapeutics Discovery, at Novo Nordisk. “We continue to push the boundaries of science through both internal and external innovation to fulfil our mission of treating millions more people living with obesity and diabetes and their associated comorbidities.”

The collaboration aims to enable the oral delivery of biologic drug candidates that are traditionally limited to injectable administration due to poor absorption in the gastrointestinal tract. The partnership combines Novo Nordisk’s deep expertise in peptide and protein therapeutics with Vivtex’s proprietary gastrointestinal screening and formulation platform to identify next-generation oral therapeutics.

“Making biologics oral has been one of the most difficult challenges in drug delivery,” said Thomas von Erlach, Ph.D., CEO and co-founder of Vivtex. “Vivtex was founded to systematically solve this problem by integrating high-throughput experimentation with computational and AI-enabled analytics. Partnering with Novo Nordisk allows us to apply our platform across important metabolic disease areas, with the goal of enabling oral therapies that would otherwise require injection.”

Vivtex’s platform combines multiple proprietary gastrointestinal screening assays, drug-delivery technologies, and computational simulation and AI capabilities to optimize the oral delivery of biologic medicines. The platform is designed to achieve high oral bioavailability and consistent in-human performance.

Following research and formulation selection, Novo Nordisk will assume responsibility for global development, regulatory activities, manufacturing, and commercialization of any resulting products.

About Vivtex Corporation
Vivtex Corporation is a biotechnology company transforming the oral delivery of therapeutics. Founded by MIT scientists Drs. Thomas von Erlach, Giovanni Traverso, and Robert S. Langer, Vivtex has developed a robotics-driven platform that integrates its proprietary GI-ORIS™ high-throughput screening system — a “GI tract on a chip” — whole-gastrointestinal tissue robotic interface published in Nature Biomedical Engineering, with AI-enabled computational modeling to design and optimize orally delivered therapeutics, including biologics, for predictable human performance. The platform enables rapid screening of thousands of formulations per day and has demonstrated near-perfect correlation with human intestinal absorption, substantially outperforming conventional in vitro models. Vivtex partners with leading biotechnology and pharmaceutical companies to advance clinical programs and expand patient access to convenient, effective oral therapies.  Vivtex operates in Cambridge, Massachusetts, USA, and Schlieren, Switzerland. For more information, visit www.vivtex.com.

About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 68,800 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, X, LinkedIn and YouTube.

Contacts for further information

Attachment

• PR260225-Vivtex.

ITM to Announce Phase 3 COMPETE Trial Post-Hoc Subgroup Analysis in Pancreatic Neuroendocrine Tumors and Host Satellite Symposium at ENETS 2026




ITM to Announce Phase 3 COMPETE Trial Post-Hoc Subgroup Analysis in Pancreatic Neuroendocrine Tumors and Host Satellite Symposium at ENETS 2026

Garching / Munich, February 25, 2026 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that it will provide further exploratory and post-hoc subgroup analysis data focusing on Pancreatic Neuroendocrine Tumors from its Phase 3 COMPETE trial in an oral presentation at the 23nd Annual European Neuroendocrine Tumor Society (ENETS) Conference, held from March 4 – March 6, 2026 in Kraków, Poland. The company will also host a conference booth (#6) and an interactive symposium on March 5, 2026, bringing together leading experts in radiopharmaceutical oncology to share their perspectives on key challenges and emerging clinical approaches for the treatment of neuroendocrine tumors (NETs).

Oral Presentation Details
Title: ¹⁷⁷Lu-edotreotide for the Treatment of Pancreatic Neuroendocrine Tumours: A Subgroup Analysis from the COMPETE Study
Presentation ID: D54
Session: Clinical science | Session 2B: Abstract session
Date and Time: Thursday, March 5, 11:50–11:57 AM (CET)
Location: Theatre Hall S2, ICE Kraków Congress Centre
Presenter: Prof. Dr. Thomas Walter, Medical Oncologist, Lyon, France

Satellite Symposium Details
Title: Vote and Learn: Radiopharmaceutical Therapy in NETs
Date and Time: Thursday, March 5, 07:45–08:45 AM (CET)
Location: Theatre Hall S2, ICE Kraków Congress Centre
Presenters: Dr. Francesca Spada, Medical Oncologist, Milano, Italy; Prof. Christophe Deroose, Nuclear Medicine Physician, Leuven, Belgium; Prof. Simron Singh, Medical Oncologist, Toronto, Canada

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

About ITM Isotope Technologies Munich SE
ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply of medical radioisotopes. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com

ITM Contact
Corporate Communications
Kathleen Noonan/Julia Westermeir
Phone: +49 89 329 8986 1500
Email: communications@itm-radiopharma.com

Investor Relations
Ben Orzelek
Phone: +49 89 329 8986 1009
Email: investors@itm-radiopharma.com

Attachment

• ITM to Announce Phase 3 COMPETE Trial Post-Hoc Subgroup Analysis in Pancreatic Neuroendocrine Tumors and Host Satellite Symposium at ENETS 2026

Synklino announces publication in American Journal of Transplantation highlighting proof-of-concept for SYN002 in eliminating CMV in human kidneys




Synklino announces publication in American Journal of Transplantation highlighting proof-of-concept for SYN002 in eliminating CMV in human kidneys

• Preclinical data demonstrate >90% reduction in human cytomegalovirus (HCMV) reactivation from latency, establishing proof-of-concept for SYN002 in human kidneys
• Data published in the American Journal of Transplantation and to be presented as a poster at the Cutting Edge of Transplantation (CEoT) Summit, Scottsdale, Arizona, 26–28 February 2026
• Regulatory clearance granted by both UK MHRA and Health Canada for a Phase 1 clinical trial of SYN002, with Canadian study to be conducted independently by Dr. Atul Humar at UHN, Toronto

COPENHAGEN, Denmark, Feb. 25, 2026 (GLOBE NEWSWIRE) — Synklino A/S, a Danish biotechnology company pioneering transformative therapies to improve kidney transplantation outcomes through better CMV prevention, today announces the publication of a preclinical study in the American Journal of Transplantation. The study titled Inhibition of cytomegalovirus reactivation by ex vivo treatment of human kidneys with the SYN002 immunotoxin is available on open access here.

The preclinical data published in the American Journal of Transplantation will be presented in the form of a poster at the Cutting Edge of Transplantation (CEoT) Summit held in Scottsdale, Arizona, from 26–28 February 2026.

The poster will include data on the safety and feasibility of the administration of SYN002 to human kidneys during normothermic machine perfusion (NMP), as well as data on the efficacy of eliminating latently infected cells from the treated kidneys. The data provide compelling proof-of-concept that SYN002 is highly efficacious and safe and that the use of SYN002 in this setting can be expected to provide clinical benefit. In the treated kidneys, reactivation from latency was reduced by >90%, compared with no reduction in the control group.

Ian McGowan, MD PhD, Chief Medical Officer, Synklino, commented: “The publication of these data in the American Journal of Transplantation represents an important validation of our approach. Despite standard of care prophylaxis, approximately 30% of patients who receive a CMV-positive donor organ still experience CMV reactivation. These findings demonstrate that SYN002 has the potential to fundamentally change how CMV is managed in transplantation, by intervening at the donor organ level before transplantation takes place.”

Establishment of the proof-of-concept follows regulatory clearance granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for a Phase 1 clinical trial of SYN002 in kidney transplantation. In Canada, Health Canada has granted regulatory clearance for an investigator-sponsored Phase 1 study to be conducted independently by Dr. Atul Humar at the Ajmera Transplant Centre, University Health Network (UHN), Toronto, one of the world’s leading transplant centres, with first patient enrolment expected in April 2026.

Thomas Kledal, Chief Executive Officer, Synklino, said: “We are highly encouraged by the preclinical data which establish proof-of-concept for SYN002 in eliminating CMV from donor kidneys prior to transplantation. Following the recent CTA approvals in both the UK and Canada, these data add to our momentum in our mission to advance SYN002 into the clinic and bring a much-needed treatment to kidney transplant patients. This is a pivotal time for us, and we are looking forward to the next major milestones.”

For further information please contact:

Optimum Strategic Communications
Mary Clark | Isabelle Abdou | Vareen Outhonesack
Email: Synklino@optimumcomms.com
Tel: +44 20 3922 0900

About Synklino
Synklino is a Danish biotechnology company pioneering transformative therapies to improve kidney transplantation outcomes through better CMV prevention. Our first-in-class breakthrough drug candidate, SYN002, is a therapeutic fusion protein designed to eliminate both active and latent CMV infection in donated organs through ex vivo organ perfusion, offering a proactive and life-changing therapy for immunocompromised transplant recipients. Following regulatory CTA approval, SYN002 is expected to enter clinical development in kidney transplantation in the second quarter of 2026.

Background

Cytomegalovirus (CMV) is the main agent involved in infectious complications following transplant surgery, and a major risk for morbidity and increased hospital readmissions. CMV is a chronic viral infection found in more than 60% of humans worldwide. A healthy individual’s immune system confines the virus to an inactive but persistent state; however, in transplant patients with suppressed immune systems, CMV emerges from latency and significantly impacts morbidity and mortality. CMV increases transplant costs by up to 50% due to long-term hospitalizations and requires difficult courses of treatment. CMV-infected organs constitute a key risk for CMV infection and complications in all transplant recipients at the time of transplantation, regardless of the recipient’s CMV status. No currently marketed or pipeline drugs can cure CMV, and current drugs can be associated with the risk of developing resistance to CMV-therapies.

SYN002 is a therapeutic fusion protein, uniquely targeting both latent and lytic CMV- infected cells. SYN002 is expected to be highly efficacious and potent compared to standard of care antiviral therapeutics which only target active (lytic) infection. Given the compound’s unique mechanism of action, SYN002 has the potential to eliminate the risk of CMV infection in immunocompromised transplant recipients who would otherwise receive a CMV-infected organ. In preclinical studies SYN002 has been shown to be fast-acting with full efficacy anticipated within the few hours that the organ is treated ex vivo (pre transplantation).

Ex vivo organ perfusion is the treatment of an organ after it has been removed from the donor, and prior to transplantation. Ex vivo organ care has evolved from storage on ice into dynamic reconditioning using machine perfusion. Continuous flushing of donor organs with fluids during machine perfusion allows enhanced preservation with assessment of critical organ function parameters. Organ perfusion enables improvements in organ function by supplementing blood products or solutions that contain important nutrients, cells, and therapeutics, such as SYN002. Ex vivo machine perfusion increases the number of organs available for transplantation, ultimately improving the chance for a life-saving outcome for patients with end stage renal failure.

Novonesis delivered strong organic sales growth of 7% in 2025




Novonesis delivered strong organic sales growth of 7% in 2025

COPENHAGEN, Denmark – February 26, 2026. Novonesis delivered strong organic sales growth of 7% and an adjusted EBITDA margin of 37.1% in 2025. The company expects a good start to 2026 and a good year overall. 

Ester Baiget, President & CEO: 

“In 2025, we continued to deliver strong organic sales growth. We achieved 7% growth, an adjusted EBITDA margin of 37.1% and a strong cash flow – despite currency headwinds. Growth was broad-based across sales areas and markets, with particularly strong performance in Emerging Markets. As a pure biosolutions player, Novonesis uniquely combines deep understanding of customers, innovation leadership and world-class scale capabilities, driving performance and strengthening resilience. In 2026, we expect another good year, with growth across all sales areas and margin expansion. We continue to execute on our strategy, positioning us to firmly deliver on our 2030 targets and beyond.”

Highlights of our full-year 2025 results:

• Broad-based organic sales growth of 7% (Q4: 4%) including the negative impact of exiting certain countries of ~1%-point (Q4: ~2%-points). Price contributed ~1%-point (Q4: ~1%-point) and sales synergies contributed ~1%-point (Q4: ~1%-point).
• Food & Health at 8% organic sales growth (Q4: 7%) including the negative impact of exiting certain countries of ~3%-points (Q4: ~5%-
points). Planetary Health at 6% organic sales growth (Q4: 2%, including double-digit growth in Energy). 
• Emerging Markets grew 9% organically (Q4: 1%) including the exit from certain countries. Developed Markets grew 6% organically (Q4: 6%).
• Adjusted EBITDA margin at 37.1% (Q4: 36.6%), up by 100 bps (Q4: up by 40 bps) including one-off expenses in Q4 and currency headwinds
for both the quarter and the year. Adjusted gross margin at 59.1% (Q4: 59.9%) up by 240bps (Q4: up by 250bps).
• Adjusted net profit increased by 17% (Q4: flat).
• NIBD/EBITDA at 1.9x, and free cash flow before acquisitions at EUR 770.4 million, or 19% of sales.
• Proposed dividend of DKK 4.25/share. DKK 2.25/share interim dividend paid Aug. 27, 2025. 2025 pay-out ratio of 58.4% of adj. net profit.
• 33 new product launches in 2025 (Q4: 14). New innovations launched over the last 5 years made up 25% of sales.
• Achievement of all six environmental and social targets for 2025 and on track for future commitments. 
• 2026 outlook: Organic sales growth between 5-7% with a good start to the year expected against a strong 2025 comparable. The outlook includes some uncertainty of potential lower consumer sentiment for the year. The outlook also includes ~1%-point from positive pricing and ~1%-point from sales synergies as well as close to 1%-point negative impact from exiting certain countries. The outlook for the 
adjusted EBITDA margin is between 37-38% with an expected margin expansion, including currency headwinds of ~50 bps vs 2025. 

Here is the link to the investor call on Novonesis full-year results for 2025: Novonesis Full-year financial statement for 2025 and annual report 2025

Get in touch

Line Fedders
Senior Media Relation Manager

media-relations@novonesis.com
+45 30 77 13 99

Tobias Bjorklund
Head of Investor Relations

tobb@novonesis.com

Attachment

• 2026-01-12m-2025-highlights_final

Incentive programs for the Executive Leadership Team, the Senior Leadership Team and directors, and other employees




Incentive programs for the Executive Leadership Team, the Senior Leadership Team and directors, and other employees

Please read the full announcement in PDF

Attachment

• 2026_02_LTI