Announcement • May 06
ImmuPharma PLC Initiates IND-Enabling Program for Kapiglucagon to Treat Diabetes ImmuPharma PLC initiated IND-enabling activities for its Kapiglucagon diabetes program, following the execution of a 'Work Order' with specialist pharmaceutical consultancy tranScrip Limited. 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. 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. The global Insulin Pump market is forecast to reach $13.6 billion sales by 2035. ImmuPharma has previously stated that it has an accelerated development plan for Kapiglucagon, through a 505(b)(2) regulatory pathway 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. 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. 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. 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. New Risk • Apr 09
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 25% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported June 2025 fiscal period end). Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (UK£29.0m market cap, or US$38.9m). Announcement • Mar 28
ImmuPharma PLC Provides Update on P140 Program Patent Progress and Supporting Data ImmuPharma PLC had received a first Combined Search and Examination Report in relation to its United Kingdom patent application for P140, filed in September 2025. The supportive response is as expected by management at this stage of the patent examination process and represents an important positive milestone in the ongoing progress of the application. ImmuPharma intends, in due course, to build on this filing through a Patent Cooperation Treaty ("PCT") application, with a view to seeking protection in key commercial territories. In parallel, ImmuPharma has completed a new study, intended to provide further supporting data for the patent application. The study was designed to stress test the associated diagnostic test and strengthen the statistical significance of the supporting dataset. The results were positive and supportive of the patent application. The scientific team is preparing a scientific manuscript describing the P140 technology platform and its mechanism of action, including recent supporting data. The Company intends to submit the manuscript to a peer-reviewed journal in due course. Following publication, the findings will be shared more broadly with the scientific community. P140 remains a core value driver for ImmuPharma. The Company continues to progress discussions with a number of potential partners, including under signed confidentiality agreements. The management team also attended the Bio-Europe Spring healthcare event in Lisbon this week, where a number of meetings were held in relation to P140. ImmuPharma remains focused on completing a value-enhancing licensing deal in 2026. ImmuPharma will provide further updates on the P140 program as appropriate. 
