Topadur Pharma AG

Zurich, Switzerland, September 09, 2025 – Topadur Pharma AG today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational therapy TOP-N53 for the treatment of digital ulcers in patients with systemic sclerosis. Systemic sclerosis is a rare, life-threatening autoimmune disease characterized by fibrosis, vascular damage, and chronic digital ulcers that severely impair patients’ quality of life. Currently, there is no approved therapy for the treatment of digital ulcers in systemic sclerosis patients, highlighting the urgent need for new therapeutic options. With Orphan Drug Designation now granted by both the FDA and the European Medicines Agency (EMA), Topadur has achieved two major milestones. These designations provide development incentives, including market exclusivity and enhanced regulatory guidance in both the U.S. and Europe. “This important recognition from the FDA underscores the urgent unmet need in systemic sclerosis and validates our innovative approach with TOP-N53’s unique bifunctional mechanism,” said Reto Naef, Founder and President of the Board at Topadur Pharma AG. Topadur is currently conducting a Phase 2a clinical trial evaluating TOP-N53 in patients with systemic sclerosis-related digital ulcers. To support recruitment and strengthen the clinical dataset, the company is expanding the study by including selected clinical centers. “Digital ulcers are a particularly severe manifestation of systemic sclerosis, and effective targeted treatments are urgently needed. Innovative approaches such as TOP-N53 could represent an important step toward improving care for these patients,” said Professor Oliver Distler, M.D., Zurich, Switzerland. About TOP-N53 TOP-N53 is a first-in-class bifunctional small molecule designed to address both vascular dysfunction and impaired tissue regeneration in systemic sclerosis. By combining nitric oxide donation with phosphodiesterase-5 (PDE5) inhibition, TOP-N53 aims to improve blood flow and promote wound healing, offering patients a novel therapeutic option. The topical administration of TOP-N53 enables maximal therapeutic efficacy directly at the site of the ulcer, while minimizing systemic drug exposure. About Topadur Pharma AG Topadur Pharma AG is a Swiss clinical-stage biopharmaceutical company dedicated to developing transformative therapies in regenerative medicine, aging-related and rare diseases. Topadur is advancing breakthrough treatments designed to improve patient outcomes and enhance quality of life for people with high unmet medical needs worldwide. For more information regarding Topadur, please visit: www.topadur.com Contact Jaan Strang Communications +41 44 755 44 66 jaan.strang@topadur.com DISCLAIMER This communication does not constitute an offer or invitation to subscribe for or purchase any securities of TOPADUR PHARMA AG. This publication may contain certain forward-looking statements and assessments or intentions concerning the company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place reliance on these statements, particularly not in connection with any contract or investment decision. The company disclaims any obligation to update these forward-looking statements, assessments or intentions. ‍ ‍ ‍ ‍

Topadur Pharma AG, a Swiss biopharmaceutical company developing innovative therapies for aging-related diseases, announces the appointment of Professor Thierry Carrel, MD, to its Board of Directors. Professor Carrel is one of Switzerland’s most accomplished cardiac surgeons. His expertise in clinical needs, regulatory navigation, and innovative technologies will provide strategic direction as Topadur moves into its next growth phase. His appointment reinforces Topadur’s commitment to delivering novel therapies through science-driven innovation. “We are honored to welcome Professor Carrel to our Board,” said Dr. Reto Naef, Chairman of the Board and interim CEO of Topadur. “With his exceptional background in academic medicine, cardiovascular surgery, and his experience with global medical innovations, Professor Carrel brings valuable expertise to our team. His contributions come at a time when Topadur is advancing multiple drug candidates through pre-clinical and clinical stages toward first-in-human efficacy data.” Professor Carrel studied medicine at the Universities of Fribourg and Bern, obtaining his MD in 1985 and completing his habilitation at the University of Zurich in 1993. He served as Full Professor and Chairman of the renowned Department of Cardiovascular Surgery at the University of Bern from 1999 until 2020. Throughout his distinguished career, Professor Carrel has performed, taught, or supervised more than 12,000 surgical procedures. He has supported many professorial careers and has authored or co-authored over 850 scientific papers. His contributions to global cardiovascular innovation extend beyond academia. He has co-founded successful medtech start-ups, including Swiss Cardio Technologies AG and CoreMedic GmbH, and has played an advisory role with numerous cutting-edge companies such as Novostia SA, Xeltis, and Abbott Cardiovascular. Professor Carrel also has a long-standing commitment to humanitarian work, leading pediatric cardiac missions in Russia, Morocco, Uzbekistan, and Mongolia. “I’m very honoured to join Topadur, a very innovative biotech company that develops highly promising molecules for the treatment of several diseases affecting an increasing number of patients. The mechanism of tissue healing occurs mainly through a physiological process, which consists in improving blood flow in the smallest vessels. This is exactly what the aging population is waiting for.” About Topadur Topadur is a patient-oriented Swiss biopharmaceutical company developing disruptive therapies for aging-associated diseases. Topadur has developed the DualTOP® technology platform consisting of new dual-acting drugs that increase cGMP levels to stimulate microcirculation, enable tissue regeneration, and avoid local oxygen deficiency. Topadur’s R&D portfolio includes promising development candidates in wound healing, medical aesthetics and oncology. For more information regarding Topadur, please visit: www.Topadur.com

Zurich-Schlieren, Switzerland, October 18th, 2024 Topadur Pharma AG, a Swiss clinical-stage biotechnology company, today announces the appointments of PD Dr. Matthias Schäfer as Chief Innovation Officer (CIO) and Prof. Dr. Jay Siegel as Chief Research Officer (CRO). Matthias Schäfer is a seasoned international leader, who uniquely combines management skills with in-depth experience in biomedical research from which he developed products and strategies with sustainable economic success. Previously, he held leadership positions as Senior Manager, Director and Business Unit Head in the healthcare industry along with an assignment as consultant and as lecturer at ETH Zurich. He holds a PhD in Biology and completed several Executive Business Trainings e.g. at the St. Gallen Management Institute (SGMI). Matthias Schäfer: “Topadur has an innovative pipeline of drug candidates with highly effective mode of action, demonstrating significant potential as disruptive therapies of various diseases with a high medical need. I am excited to support the Topadur team in advancing the product development toward market entry with my expertise and enthusiasm”. Jay Siegel brings to Topadur over 40 years of experience in molecular design and chemical synthesis research. He was previously Dean of a School of Pharmaceutical Science and Technology and Director of a Laboratory for Process Research on the synthesis of API for the Pharmaceutical Market. He earned his PhD at Princeton, did Fulbright studies at ETH, and completed a postdoc with JM Lehn at Strasbourg. Jay held a professor/director position at the University of Zurich for over 11 years. He is most recently Senior Advisor to the President of the University of Hong Kong. Jay Siegel: “I have followed the development of Topadur and its drug pipeline for over a decade. The special physical and biological properties of these bioactive molecules present a great promise for the future of targeted therapies and multiple action agents. I am confident there are positive materials in hand and on the developmentary horizon.” “I’m excited to announce Matthias Schäfer and Jay Siegel's appointment. Together, they bring profound knowledge and sound experience in business development within healthcare. Matthias and Jay will significantly strengthen our team, adding complementary expertise. Currently, Jay has a mandate as a consultant with Topadur and will take over the full-time CRO role from early next year upon completing his current obligations in Hong Kong,” said Pascal Brenneisen, CEO Topadur Pharma AG. About Topadur Topadur is a patient-oriented biotech company developing disruptive therapies for aging diseases. The Swiss-based biotech company developed the DualTOP™ technology platform consisting of new dual-acting drugs that increase cGMP levels to stimulate microcirculation, enable tissue regeneration, and avoid local oxygen deficiency. Topadur’s R&D portfolio consists of promising development candidates in regenerative medicine, oncology, ophthalmology and medical aesthetics. The DualTOP™ technology will contribute to promoting long healthy life. For more information regarding Topadur Pharma AG, please visit: www.topadur.com Contact Jaan Strang Head Project Management +41 44 755 44 66 jaan.strang@topadur.com DISCLAIMER This communication does not constitute an offer or invitation to subscribe for or purchase any securities of TOPADUR PHARMA AG. This publication may contain certain forward-looking statements and assessments or intentions concerning the company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place reliance on these statements, particularly not in connection with any contract or investment decision. The company disclaims any obligation to update these forward-looking statements, assessments or intentions. ‍