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."

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

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