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Thermo Fisher CDMO selected for Kapiglucagon pro
ImmuPharma PLC has selected Thermo Fisher Scientific as its drug product contract development and manufacturing organisation for its Kapiglucagon program, a significant Chemistry, Manufacturing and Controls milestone expected to support pharmaceutical development and IND-enabling preparations. This follows the appointment of Bachem AG as the API manufacturing partner, and ImmuPharma is evaluating a potential 505(b)(2) regulatory pathway in the United States for Kapiglucagon, a proprietary glucagon prodrug for Type 1 diabetes. The company has also secured funding to advance the asset over the next two years, with the goal of progressing towards IND submission and first-in-human studies. Disclaimer*
About this update from Immupharma Plc
This announcement contains inside information for the purposes of the UK Market Abuse Regulations ('UK MAR'). Upon publication of this announcement, this inside information (as defined in UK MAR) is now considered to be in the public domain. The person responsible for arranging the release of this announcement on behalf of the Company is tim mccarthy, Chief Executive Officer. 22 July 2026 ImmuPharma PLC ("ImmuPharma" or the "Company") ImmuPharma selects Thermo Fisher Scientific drug product CDMO for Kapiglucagon program ImmuPharma plc (LSE AIM: IMM), the specialist drug discovery and development company, is pleased to announce that, following a competitive tender process, it has selected Thermo Fisher Scientific, the world leader in serving science, as its drug product ("DP") and contract development and manufacturing organisation ("CDMO") for its Kapiglucagon program. Thermo Fisher's Patheon pharma services is a leading global pharmaceutical development and manufacturing organization, supporting pharmaceutical and biotechnology companies from early-stage development through to commercial supply. The selection of Thermo Fisher represents an important Chemistry, Manufacturing and Controls ("CMC") milestone for the Kapiglucagon program and is expected to support the next stages of pharmaceutical development and IND-enabling preparation. This development follows the Company's recent announcement regarding the appointment of Bachem AG as API manufacturing partner for the Kapiglucagon program. The program is being advanced through a streamlined development strategy, with ImmuPharma evaluating a potential 505(b)(2) regulatory pathway in the United States, leveraging existing data on native glucagon, subject to FDA confirmation. About Kapiglucagon Kapiglucagon is a proprietary glucagon prodrug being developed for Type 1 diabetes ("T1D") applications, with a focus on overcoming the inherent physicochemical limitations of native glucagon. The program is designed to improve solubility and formulation stability, with potential application in dual-hormone artificial pancreas systems and other glucagon-based therapeutic settings. ImmuPharma believes Kapiglucagon represents an important strategic opportunity alongside its lead asset, P140. The Company has previously stated that it intends to pursue an accelerated development plan for Kapiglucagon, including evaluation of a 505(b)(2) regulatory pathway, and that the program is supported by the recently approved funding initiative intended to advance the asset over the next two years. Next steps The selection of Thermo Fisher is expected to support the DP workstream of the Kapiglucagon CMC program. In parallel, ImmuPharma intends to continue advancing the regulatory and development strategy for Kapiglucagon, including future regulatory interactions and, subject to alignment with health authorities, progression towards IND submission and first-in-human studies. Dr Sébastien Goudreau, Chief Scientific Officer of ImmuPharma, said: " We are pleased to select Thermo Fisher as DP CDMO for the Kapiglucagon program. This represents an important step in strengthening the CMC foundation of the program as we continue to advance Kapiglucagon toward clinical development. " Jennifer Cannon, President, Commercial, Biopharma Services, Thermo Fisher Scientific, said: "We are pleased to collaborate with ImmuPharma on the Kapiglucagon program. Our team is committed to helping customers advance innovative therapies by providing the development and manufacturing expertise needed to advance programs efficiently through key development milestones. We look forward to supporting ImmuPharma as the program progresses." For further information please contact: ImmuPharma PLC ( www.immupharma.co.uk ) Tim McCarthy, Chief Executive Officer Lisa Baderoon, Head of Investor Relations +44 (0) 207 206 2650 + 44 (0) 7721 413496 SPARK Advisory Partners Limited (NOMAD) Neil Baldwin Stanford Capital Partners (Joint Broker) Patrick Claridge, Bob Pountney SI Capital (Joint Broker) Nick Emerson +44 (0) 203 36 8 3550 +44 (0) 20 3650 3650 +44 (0) 1483 413500 Notes to Editors About ImmuPharma PLC ImmuPharma PLC (LSE AIM: IMM) is a specialty biopharmaceutical company that discovers and develops peptide-based therapeutics. The Company's portfolio includes novel peptide therapeutics for autoimmune diseases and anti-infectives. For additional information about ImmuPharma please visit www.immupharma.co.uk . ImmuPharma's LEI (Legal Entity Identifier) code: 213800VZKGHXC7VUS895. Kapiglucagon: A Stable Next-Generation Glucagon Prodrug for Diabetes Kapiglucagon has been developed to address the key pharmaceutical limitations associated with native glucagon. It is a water-soluble glucagon prodrug designed to maintain high stability in aqueous solution while regenerating native glucagon in vivo following subcutaneous administration. Unlike native glucagon, which rapidly aggregates and forms fibrils in solution, Kapiglucagon demonstrates excellent solubility and formulation stability, enabling the development of clean, saline-based formulations that do not clog pump-based delivery systems. This improved physicochemical profile makes Kapiglucagon particularly well suited for continuous or intermittent delivery in advanced diabetes technologies, including next-generation artificial pancreas systems. By combining the therapeutic activity of native glucagon with a formulation that overcomes its inherent instability, Kapiglucagon has the potential to provide more reliable and practical dual-hormone automated glucose control solutions for patients with Type 1 Diabetes and avoid the long-term health complications of inadequate blood glucose control. ImmuPharma's vision is to position Kapiglucagon as a key enabling solution for next-generation artificial pancreas technologies. By overcoming the long-standing instability of native glucagon in aqueous formulations, Kapiglucagon offers the potential to deliver a stable, pump-compatible glucagon source, allowing dual-hormone closed-loop systems to operate safely and effectively. Through this innovation, ImmuPharma aims to contribute to a new generation of diabetes care in which artificial pancreas systems can significantly reduce the daily burden of disease while improving metabolic control and patient quality of life . About 505(b)(2) regulatory approval A 505(b)(2) is a U.S. FDA drug approval pathway that sits between a full NDA and a generic. The 505(b)(2) approval route allows a company to obtain approval for a modified version of an existing drug by relying partly on data which the FDA already has for the reference product, in this case a glucagon brand. The timeframe, cost and clinical study requirements for completing such a program may be considerably reduced compared to a normal NDA (new drug application) that follows a full 505(b)(1) NDA development pathway. A (PTE) Patent Term Extension of 5 years may also be applied to the existing patent life of Kapiglucagon which could result in a patent expiry extension to 2043. Kapiglucagon has established a strong scientific rationale and a growing body of supporting CMC and preclinical data, which the Company believes provides a solid foundation for further development. The first step is expected to be a Pre-IND meeting with the FDA to align on the proposed regulatory pathway and the scope of the required CMC, preclinical and clinical program. Following this interaction, the Company intends to advance the remaining development activities, including IND-enabling work, with the objective of entering a focused clinical study designed to generate safety, pharmacokinetic and pharmacodynamic data to support the next stage of value creation for Kapiglucagon. Glossary CMC Chemistry, Manufacturing and Controls CDMO Contract Development and Manufacturing Organisation FDA U.S. Food and Drug Administration IND Investigational New Drug NDA New Drug Application