MRM Health NV

GHENT, Belgium--( BUSINESS WIRE )-- MRM Health NV, a clinical-stage biopharmaceutical company developing innovative therapeutics for inflammatory, CNS and metabolic diseases, today announced the appointment of Grégoire Franoux, M.B.A., to the newly created role of Chief Business Officer. Concurrently, the company has strengthened its Board of Directors with the appointment of industry veteran Ron Robison, M.D. “ We are excited to have Grégoire join our executive team at this pivotal moment for MRM Health, on the cusp of late-stage clinical development for our lead candidate MH002 in ulcerative colitis and pouchitis, from our proprietary CORAL platform designed to harness the full power of the gut microbiome to develop effective and safe therapeutics,” said Sam Possemiers, Ph.D., Chief Executive Officer of MRM Health. “Grégoire’s extensive expertise in corporate development, combined with his strategic acumen, will be crucial as we continue to advance our pipeline and expand our reach. ” Mr. Franoux will lead the company’s business development and corporate strategy, focusing on forging strategic partnerships and driving growth. He brings 20 years of experience in strategic planning, licensing, business development and corporate finance within the biotechnology sector. He joins MRM Health from Belfius Bank, where he was spearheading Corporate Finance and Capital Markets activities in the Life Sciences sector. Prior to joining Belfius, Gregoire held senior business development positions at Oxurion, Gruenenthal GmbH and Flamel Technologies. He holds an M.S. in Biotechnology from ESIEE Paris, an M.S. in International Finance from IAE Aix-Marseille, and an Executive M.B.A. from INSEAD. “ It is an exciting time to join the MRM Health team as the company makes important progress advancing next-generation LBPs for inflammatory, CNS and metabolic diseases. I look forward to optimizing the value of MRM’s potentially life-altering therapies and delivering them to patients in need ,” commented Grégoire Franoux. In addition, MRM Health welcomes Ron Robison, M.D., to its Board of Directors. Ron, who previously served as Vice President at AbbVie, brings over three decades of experience in drug development and commercialization. Ron also served in global senior pharmaceutical R&D leadership roles at several organizations, including Mallinckrodt Medical, Sanofi/Sterling Winthrop, Nycomed, Amersham Health, Abbott and Head of R&D and Chief Medical Officer at Solvay Pharmaceuticals. Ron has overseen the approval of more than 20 new molecular entities worldwide with over ten innovative clinical indications obtained under FDA breakthrough therapy designation. Dr. Robison holds an M.D. from the Oregon Health Sciences University, an M.S. in Medical Informatics/Biomedical Engineering from the University of Utah, and a B.S. from Oregon State University. MRM Health Chairman Werner Cautreels added, “ We are thrilled to have Ron join our Board. His deep industry knowledge and experience progressing assets through clinical and global regulatory development will be invaluable as we continue to grow and develop potentially transformative therapies. ” -Ends- About MRM Health MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program MH002 is in preparation for pivotal clinical development in Ulcerative Colitis and/or in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL ® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD. For more information, please visit the website at www.mrmhealth.com .

Recent safety and efficacy data in both Ulcerative Colitis and Pouchitis continue to support MH002’s potential in indications characterized by mucosal damage and inflammation. GHENT, Belgium--(BUSINESS WIRE)-- MRM Health NV, a clinical-stage biopharmaceutical company developing innovative therapeutics for inflammatory, CNS and metabolic diseases, today announced it will present positive data for its lead asset, MH002, a live microbial consortium therapy for Inflammatory Bowel Diseases, in two oral presentations during the 2024 Digestive Disease Week® (DDW) meeting, being held May 18-21, 2024 in Washington, D.C. at the Walter E. Washington Convention Center. Late Breaker Presentation Details Session Title: IMIBD Late Breakers and Innovations in IBD Presentation Title: Safety and Efficacy of MH002, an Optimized Live Biotherapeutic Product, for the Treatment of Mild to Moderate Ulcerative Colitis: A First-in-Disease, Double-Blind, Randomized Clinical Trial Presenter: Séverine Vermeire, Ph.D., Principal Investigator and Scientific Advisor of MRM Health Date and Time: Sunday, May 19, 2024, 3:15 PM – 3:30 PM EDT Location: Ballroom B Poster of Distinction Presentation Details Session Title: Microbial Therapies for GI Disease Session Sponsor: AGA Presentation Title: MH002, an Optimized Live Biotherapeutic Product for the Treatment of Inflammatory Bowel Diseases, Has Mode-of-Actions Linked to Restoration of Intestinal Dysbiosis, Mucosal Integrity, and Immune Homeostasis Poster Number: Mo1919 Presenter: Sam Possemiers, Ph.D., Chief Executive Officer of MRM Health Date and Time: Monday, May 20, 2024, 12:30 PM – 1:30 PM EDT This poster has been selected by DDW as a “Poster of Distinction,” recognizing the top 10% of all AGA abstracts selected for poster presentation. Key findings that will be presented include: - The primary endpoint from a placebo-controlled Phase 2a trial in mild-to-moderate Ulcerative Colitis patients was met, with an excellent safety pro tolerance at a fixed dose of 400mg per day over 16 weeks administration. - Initial efficacy on disease activity was evidenced in clinically relevant parameters, including a 12% improvement in Mayo Endoscopic Severity (MES) score (p=0.05, 1-sided Wilcoxon rank sum test), while placebo worsened by 5%. Stool consistency significantly improved in the MH002 treatment group as from week 2 (p=0.006; 1-sided Student t-test). At the end of the eight-week period, 18% of subjects achieved clinical remission compared to 0% of the placebo group (Per-protocol analysis). In contrast to previous trials with other live biotherapeutics in UC, this study was performed successfully without vancomycin preconditioning. - At a mechanistic level, anti-inflammatory effect was demonstrated with a 42% decrease in median fecal calprotectin (a clinically relevant bowel inflammation marker) compared to 18% in placebo at week 8. Furthermore, microbiome restoration occurred in parallel with clinical effects, and differential gene expression analysis showed downregulation of genes involved in inflammation. These findings were in line with the mode-of-action of MH002 and linked to restoration of intestinal dysbiosis, mucosal integrity, and immune homeostasis. -Ends- About MH002 MH002 is currently the most advanced rationally designed live microbial consortium therapy in Inflammatory Bowel Diseases, having demonstrated safety and efficacy in phase 2a trials in both Ulcerative Colitis and Pouchitis. It was developed through MRM Health’s proprietary CORAL® Technology and comprises six well-characterized and safe commensal strains, selected and optimized to tackle key disease-driving mechanisms with enhanced potency, resiliency, and engraftment. MRM Health’s breakthrough scalable and standardized cGMP manufacturing platform allows for the manufacturing of complete consortia as a single drug substance. This ability of CORAL® to enable scalable, cost-effective manufacturing of complete optimized consortia in a single process is expected to provide both key regulatory and patient compliance advantages. About MRM Health MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program MH002 is in preparation for pivotal clinical development in Ulcerative Colitis and/or in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD. For more information, please visit the website at . View source version on businesswire.com: Contacts For further information please contact: MRM Health Dr Sam Possemiers – CEO Christiane Verhaegen – CFO Tel: +32.9.277.08.50 info@mrmhealth.com Stern Investor Relations Stephanie Ascher Stephanie.ascher@sternir.com +1 212-362-1200 Source: MRM Health View this news release online at:

Primary endpoint reached: safe and well tolerated, no evidence of adverse reactions related to MH002 when administered for 16 weeks Initial efficacy observed in clinically relevant parameters, including 17% significant improvement over placebo at week 8 in centrally-assessed Mayo Endoscopic Severity score (p=0.05) and significant improvement of stool consistency seen as from 2 weeks of treatment (p=0.006) At a mechanistic level, anti-inflammatory effects demonstrated by 42% decrease in median fecal calprotectin (a bowel inflammation marker) relative to placebo (18%) Full analysis and presentation of the data by end 2023; Progression to Phase 2/3 development initiated MH002 is currently the most advanced rationally-designed microbiome consortium therapy in the UC field GHENT, Belgium--(BUSINESS WIRE)-- MRM Health NV, a clinical-stage biopharmaceutical company focused on developing next-generation live microbiome consortia therapeutics, today reports positive topline results from its Phase 2a clinical trial with MH002 in mild-to-moderate Ulcerative Colitis (UC). MRM Health’s MH002-UC-201 study was a multi-center, double-blind, randomized, placebo-controlled trial in 45 UC patients at multiple clinical sites in Belgium, Poland and Czech Republic. The study was designed to evaluate safety (primary endpoint), initial efficacy and mechanistic effects of MH002 over eight weeks, with a further eight-week extension period. More information about the trial is available at clinicaltrialsregister.eu. The primary endpoint was met with an excellent safety pro tolerance at a fixed dose of 400mg per day over 16 weeks administration. Treatment-Emergent Adverse Events (TEAE) were reported in 35% of patients allocated to MH002 treatment compared to 57% when treated with placebo and there was no evidence of adverse reactions related to MH002. Initial efficacy on disease activity was evidenced in clinically relevant parameters, including a 12% improvement in Mayo Endoscopic Severity (MES) score (p=0.05, 1-sided Wilcoxon rank sum test), while placebo worsened by 5%. Stool consistency significantly improved in the MH002 treatment group as from week 2 (p=0.006; 1-sided Student t-test). At the end of the eight-week period, 18% of subjects achieved clinical remission compared to 0% of the placebo group (Per-protocol analysis). As opposed to previous trials with other live biotherapeutics in UC, this study was performed successfully without vancomycin preconditioning. At a mechanistic level, anti-inflammatory effect was demonstrated with 42% decrease in median fecal calprotectin (a clinically relevant bowel inflammation marker) compared to 18% in placebo at week 8. “These early results indicate that MH002 is safe and well tolerated by patients, and has potential efficacy in mild-to-moderate UC patients who have not responded sufficiently to first-line treatment,” commented Séverine Vermeire, coordinating investigator of study MH002-UC-201 and Professor of Medicine at the KU Leuven, Belgium. “There is a significant absence of treatments for UC patients, particularly in this population, so I look forward to conducting the full analysis of the data and following MH002’s progression through the clinic.” Bruce Sands, Professor of Medicine at the Icahn School of Medicine at Mount Sinai, New York and paid consultant to MRM Health, added: “MH002’s mechanism of action and anti-inflammatory effect in UC look very promising, with the potential of a highly favorable benefit/risk balance, pending larger confirmatory studies. These topline results also suggest that this formulation could have applications across a wider range of other inflammatory bowel disorders, including pouchitis, in which MH002 is also being tested.” Full analysis and presentation of the data is expected by the end of 2023. The Company has initiated to progress the program into Phase 2/3 development. Ludo Haazen, Chief Medical Officer at MRM Health, added: “This first clinical study enables us to move forward with our clinical programme in UC. We are excited to see that MH002 differentiated in this early study significantly and consistently from placebo in clinically relevant parameters, including the centrally assessed MES, which was supported by the mechanistic parameters we have measured.” MH002 is currently the most advanced rationally-designed consortium therapy in the UC field. It was developed through MRM Health’s proprietary CORAL® Technology and comprises six well-characterized commensal strains, selected and optimized to tackle key disease-driving mechanisms with enhanced potency, resiliency, and engraftment. Production is via MRM Health’s breakthrough scalable and standardized cGMP manufacturing platform, allowing the manufacturing of complete consortia as a single drug substance. The ability of CORAL® to enable scalable, cost-effective manufacturing of complete optimized consortia in a single process is expected to provide both key regulatory and patient compliance advantages. In addition to the recently completed UC trial, MH002 is being tested in an ongoing multi-center, open label Phase 2 study enrolling patients with acute Pouchitis, a rare disease with high unmet medical need. Sam Possemiers, Chief Executive Officer at MRM Health, said: “These early clinical data are very important for the Company, since they further validate our proprietary CORAL® technology which underlies our portfolio of live biotherapeutic products. The data enables us to take the next steps in our business strategy where we will be engaging with regulatory agencies in all territories and potential new partners as well as driving forward the rest of our development portfolio.” -Ends- About MRM Health MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program MH002 is in preparation for pivotal clinical development in Ulcerative Colitis, upon obtaining positive clinical results in a phase 2a clinical trial, and is being evaluated in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD. For more information, please visit the website at . About IBD and UC Ulcerative colitis (UC) is a chronic, autoimmune, inflammatory bowel disease (IBD) characterized by mucosal inflammation of the colon resulting in debilitating diarrhea, abdominal pain, and rectal bleeding with significant impact on quality of life of patients and an increased risk of colorectal cancer development. Whereas many treatments exist and are in development for moderate-to-severe UC, only very limited options are available for mild-to-moderate disease. Current therapies have a merely symptomatic anti-inflammatory and/or an immunosuppressant effect and in many cases fail to induce enduring remission and/or cause potentially severe adverse events. These treatments also do not tackle what is considered as one of the core problems of UC, the overall poverty of microorganisms present in the gut of UC patients, also termed gut dysbiosis. MH002 is designed to enrich the gut microbiome of UC patients and thereby tackle what is considered a root cause of the disease. View source version on businesswire.com: Contacts For further information please contact: MRM Health Dr Sam Possemiers – CEO Christiane Verhaegen – CFO Tel: +32.9.277.08.50 info@mrmhealth.com Instinctif Partners (media) Melanie Toyne-Sewell Giulia Lasagni Tel: +44 207 457 2020 MRMHealth@instinctif.com Source: MRM Health NV View this news release online at: