ImmuPharma Initiates IND-Enabling Program for Kapiglucagon to treat Diabetes

May 5, 2026

ImmuPharma plc, (LSE AIM: IMM), the specialist drug discovery and development company, is pleased to announce the initiation of IND-enabling activities for its Kapiglucagon diabetes program, following the execution of a ‘Work Order’ with specialist pharmaceutical consultancy tranScrip Limited (“tranScrip”).

Under the agreement, tranScrip will support the development of the regulatory strategy and the preparation and execution of a pre-IND meeting with the FDA, including the preparation of an integrated briefing package and IND planning activities.

The program is expected to progress through a streamlined development pathway, with ImmuPharma evaluating a 505(b)(2) regulatory approach 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 the treatment of Type 1 diabetes (T1D), to overcome 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, which are expected to support the development of next-generation alternatives to current insulin-only pump devices. Through this innovation, ImmuPharma aims to contribute to next-generation diabetes care, in which artificial pancreas systems, may reduce disease burden while improving metabolic control and patient quality of life. The global Insulin Pump market is forecast to reach $13.6bn sales by 2035 (Source: Roots Analysis).

ImmuPharma believes Kapiglucagon represents an important strategic opportunity, alongside its lead asset, P140. ImmuPharma has previously stated that it has an accelerated development plan for Kapiglucagon, through a 505(b)(2) regulatory pathway (described in notes) and that the program is being supported by the recently approved funding initiative, which is intended to advance the asset over the next two years.

Next steps

Kapiglucagon has established a strong scientific rationale and a growing body of supporting manufacturing and preclinical data, which the Company believes provides a solid foundation for further development. A key milestone in the IND-enabling process will be a pre-IND meeting with the FDA to align on the regulatory pathway and the scope of the required Chemistry, Manufacturing and Controls (CMC), preclinical and clinical program. Following this meeting, ImmuPharma intends to progress towards IND submission and, subject to regulatory alignment, first-in-human studies to support the next stage of value creation for Kapiglucagon.

Dr Sébastien Goudreau, Chief Scientific Officer of ImmuPharma, said:

“The initiation of IND-enabling activities represents an important step in advancing Kapiglucagon towards clinical development. By establishing a clear regulatory pathway, we aim to efficiently and cost-effectively progress the program towards first-in-human studies and position it for future partnering opportunities.”

Mark Corbett, Chief Executive Officer of tranScrip, said:

“tranScrip is pleased to be working alongside ImmuPharma at this important stage of the Kapiglucagon program. By combining regulatory strategy with hands-on preparation for FDA interaction, we aim to help ImmuPharma move forward with clarity, confidence and momentum toward IND-enabling milestones.”

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Prodrug

What is a Prodrug?

A prodrug is a pharmacologically inactive or much less active compound that is converted inside the body (usually by metabolic enzymes) into the active drug that actually produces the therapeutic effect.

Lisa Baderoon

Non-Executive Director and Head of Investor Relations

Lisa has spent over 25 years working within the City of London being involved with a diverse portfolio of clients from a variety of sectors but with a leaning towards emerging, high growth businesses advising both private and public companies on their financial and corporate strategies aligned to stakeholder and investor interests, as well as a strong acumen in media communication. During this time, she has been involved in a multitude of client transactions spanning private fund raisings, Initial Public Offerings (IPOs), secondary high profile capital raisings and mergers and acquisitions both in the UK and internationally.

Lisa had a successful career spanning 20 years as a Partner at Buchanan Communications, one of the leading City financial public relations agencies. As one of the youngest Board members, she was involved in the successful five-year earnout, as part of Buchanan being acquired by the FTSE 100 rated WPP Plc in 1997.

Lisa founded Just B Communications Ltd in 2012 with the key objective of working with a more select number of clients and providing a greater degree of bespoke advisory services thus becoming more integral to the day to day corporate and strategic development for these businesses. She has successfully advised a number of public and private companies, at Board level, on corporate strategy, stakeholder and investor communications, capital raisings, dual listings, licensing and M&A. Media profiling, where required, has also played an important role in advisory activities.

Lisa was appointed Head of Investor Relations at ImmuPharma in 2012 and most recently appointed as a Non-Executive Director in July 2021.

Ketan Patel

Independent Non-Executive Director

Ketan is an experienced investment professional who brings extensive expertise in financial markets, with a particular focus on the UK healthcare and life science sectors. He has been a long-term investor in UK markets, working as both an analyst and Fund Manager, managing institutional, retail, and charity mandates. Ketan began his career at JP Morgan before moving to Insight Investment, where he served as a global Pharmaceutical and Healthcare analyst. He then spent over 20 years at EdenTree Investment Management, where he was responsible for UK equity and global equity income strategies, consistently delivering upper-quartile performance.

Ketan combines rigorous fundamental analysis with risk-focused investment strategies. He is also a published thought leader on sustainability and investment themes. Ketan is a CFA Charterholder and holds an MSc in Economic History from the London School of Economics, an MSc in Geography from King’s College London, and a BA (Hons) in History and Geography from Queen Mary University, London.

Dr Laurence Reilly MD, LLM

Senior Independent Non-Executive Director

Dr Laurence Reilly has been appointed as Senior independent Non-Executive Director and Chair of the Audit Committee. Dr Reilly brings extensive experience in managing late-stage clinical programs through to approval, in addition to commercial and business development experience.

He is currently Vice President of Research & Investments, working with Royalty Pharma, a New York based life science investment company focussing on acquisition of biopharmaceutical royalties and funding of innovation across the biopharmaceutical industry.

Through his consulting practice (Acumen Life Science Investment Consulting) Dr Reilly has provided strategic consulting and due-diligence services to biotech companies, life science venture capital and private equity clients. He also served as Chief Medical Officer for Cellectar Biosciences, New Jersey, a late-stage oncology biotech company. Prior to founding his consulting practice, Dr Reilly served as Chief Scientific Officer and Vice President at Avillion, a drug development company focused on the co-development and financing of drug candidates, where he was responsible for clinical and strategic oversight of co-development programs and partnering with both large pharma and biotech, including Pfizer, Merck KGaA and AstraZeneca. Dr. Reilly previously served as a Clinician – Clinical Development & Medical Oversight at Pfizer and at Lundbeck as Medical & Scientific Advisor.

Dr Reilly earned his medical degree from the University of Liverpool Medical School, U.K., and practiced as Neurosurgery Resident at Queen Elizabeth University Hospital in Birmingham. Dr Reilly also holds a Masters Degree in Law from De Montfort University, U.K.

Dr Tim Franklin PhD, MBA

Chief Operating Officer

Tim has 38 years’ experience in the biopharmaceutical industry. He worked in clinical research, sales & marketing, and global strategic marketing for Warner Lambert, Wellcome and SmithKline Beecham. He later moved to the capital markets where he became a top-ranked pharmaceuticals analyst at Dresdner Kleinwort investment bank. He applied his experience to stock selection at hedge funds and advised several small biotechnology companies on corporate and commercial strategy and access to capital. He holds a BSc in Medicinal Chemistry and a PhD in Pharmacology from Loughborough University and an MBA from Warwick Business School.

Dr Laura Mauran-Ambrosino Ph.D.

Head of R&D

Born in Montpellier, France, Dr. Mauran-Ambrosino obtained her PhD in Chemistry from the Université de Bordeaux as a CIFRE fellow under the co-supervision of Dr. Goudreau. She then conducted postdoctoral research in cell biology at the Centre Hospitalier Universitaire (CHU) Pellegrin in Bordeaux.

In 2018, she joined Ureka, where she established both the Biology and Analytical Chemistry departments. In 2021, she became Chief Scientific Officer of Ureka Pharma. Since 2025, Dr. Mauran-Ambrosino has served as Head of R&D of the ImmuPharma Group.

Dr. Mauran-Ambrosino was a key contributor to the development of several programs, including BioAMB, BioCIN, the P140 companion diagnostic, and Kapiglucagon.

Ashley Clarke ACA

Chief Financial Officer & Company Secretary

Ashley brings over a decade of experience in the financial sector. She began her career at a Big Four accounting firm and later advanced her professional expertise by earning her ACA qualification with a respected local firm.

Her professional journey is rooted in auditing, where she developed expertise working with a diverse portfolio of audit and non-audit clients across various industries. Ashley’s experience spans from supporting SMEs to managing large international group consolidations, giving her a comprehensive understanding of financial management across different business scales.

Ashley has been closely involved with the company’s accounts for several years via outsourced accountants, providing her with deep familiarity with its operations. Now, as Group CFO and Company Secretary, she is poised to leverage her extensive knowledge to drive strategic financial growth and ensure robust fiscal management.

Dr Sébastien R. Goudreau Ph.D.

Chief Scientific Officer

Born in Sherbrooke, Québec, Canada, Dr. Sébastien Goudreau obtained his PhD in Chemistry from the Université de Montréal as an NSERC fellow before conducting postdoctoral research at ETH Zürich as an FRQNT fellow. He later returned to Canada, where he co-founded FindMolecule Inc. and worked in the pharmaceutical industry.

Dr. Goudreau joined ImmuPharma in 2014 as Research Director and established the Ureka research laboratories in Bordeaux. Following the merger of ELRO and Ureka in 2019, he became Chief Scientific Officer of Ureka Pharma. In 2021, he was appointed Chief Executive Officer of ImmuPharma Biotech, and since 2025 he has served as Chief Scientific Officer of the ImmuPharma Group.

Dr. Goudreau and his team are credited with the discovery and development of several innovative programs, including BioAMB, BioCIN, the P140 companion diagnostic, and Kapiglucagon.

Tim McCarthy FCCA, MBA

Chief Executive Officer

Tim has 40 years’ international senior level business experience in high growth biotech, healthcare and technology companies. He is also Chairman of Incanthera plc. Tim was formerly Chairman of 4basebio plc and CEO and CFO of a number of UK public listed and private companies including, Alizyme plc and Peptide Therapeutics Group plc, and has a core understanding of AIM and its regulatory processes. Co-founding a number of healthcare and biotechnology companies, he has helped raise substantial amounts of equity capital and also advised and worked at Board level for a diverse range of companies internationally, in areas such as business strategy, mergers & acquisitions, due diligence and licensing.