Bioanalytical CRO partner for Kapiglucagon
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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.
10 August 2026
ImmuPharma PLC
("ImmuPharma" or the "Company")
ImmuPharma selects Kymos Group as bioanalytical CRO partner for Kapiglucagon
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 Kymos Germany/Prolytic ("Kymos Group"), a GLP-certified, GCP-compliant and FDA-inspected European contract research organisation ("CRO"), as bioanalytical CRO partner for its Kapiglucagon program.
The selection of Kymos Group represents a further important milestone in the progression of Kapiglucagon and is expected to support the bioanalytical work required for the program's non-clinical and clinical development.
Kymos Group will support the development and validation of regulated bioanalytical methods for Kapiglucagon, including subsequent analysis of samples generated during the nonclinical and Phase 1 clinical programs.
This development follows ImmuPharma's recent announcements regarding the appointment of Thermo Fisher as CMC partner and Bachem AG as API manufacturing partner for the Kapiglucagon program. The Kapiglucagon program is being advanced through a streamlined development strategy, with ImmuPharma evaluating a 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.
Dr Sébastien Goudreau, Chief Scientific Officer of ImmuPharma, said:
"We are pleased to appoint Kymos Group as bioanalytical CRO partner for the Kapiglucagon program. Kymos brings relevant peptide bioanalysis expertise and the capabilities required to support the program through its nonclinical and early clinical development. This appointment represents another important step in building the development infrastructure required to advance Kapiglucagon towards the clinic."
Joan Puig de Dou, Chief Executive Officer of Kymos Group, said:
"We are proud to support ImmuPharma in the development of Kapiglucagon, bringing our expertise in peptide bioanalysis to this promising program. Our company and team are fully committed to early-stage projects, empowering start-ups and biotech's with tailor-made support of the highest quality standards, as they advance through pre-clinical and clinical stages."
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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.
About Kymos Germany / Prolytic
Kymos Germany/Prolytic is the Frankfurt-based German bioanalytical site within the Kymos Group, specialising in pharmacokinetics and GLP/GCP-compliant bioanalysis for small molecules, biologics, nucleic acids, biomarkers, and related clinical and preclinical studies. Following its integration into Kymos in 2020, the business expanded Kymos' European bioanalytical platform and now serves pharma and biotech clients from its Frankfurt laboratory. For more information, please go to: www.kymos.com
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
CRO Contract Research Organisation
FDA U.S. Food and Drug Administration
IND Investigational New Drug
NDA New Drug Application
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