Core Viewpoint - Biodexa Pharmaceuticals PLC, a clinical-stage biopharmaceutical company, reported its preliminary results for the year ended December 31, 2025, focusing on innovative treatments for gastrointestinal cancers and type 1 diabetes [3][11]. Company Overview - Biodexa is headquartered in Cardiff, UK, and is listed on NASDAQ under the ticker BDRX. The company is developing products targeting gastrointestinal cancers, including Familial Adenomatous Polyposis (FAP) and Gastrointestinal Stromal Tumors (GIST) [3][11]. - The lead development programs include eRapa for FAP and Non-Muscle Invasive Bladder Cancer, MTX240 for GIST, and tolimidone for type 1 diabetes [3][11][12]. Development Pipeline - The company has transitioned from a drug delivery focus to a therapeutics company, with all pipeline assets currently at the clinical stage [12]. - The development pipeline includes: - eRapa: undergoing a Phase 3 trial for FAP and a Phase 2 study for Non-Muscle Invasive Bladder Cancer [16][19]. - MTX240: in-licensed from Otsuka, ready for Phase 1 studies targeting GIST [12][38]. - Tolimidone: in Phase 2a for type 1 diabetes, with potential disease-modifying effects [31][42]. Clinical Trials and Milestones - In 2025, significant milestones included the initiation of the Phase 3 Serenta trial for eRapa, with 168 patients expected to be enrolled across multiple sites in the US and Europe [23][37]. - The company received FDA Fast Track designation and Orphan Drug Designation for eRapa, enhancing its development prospects [37]. - The first patient in the Phase 3 trial was enrolled in August 2025, with European enrollment commencing in December 2025 [36][37]. Financial Overview - R&D expenditure for 2025 was £3.96 million, a decrease of 27.2% from £5.44 million in 2024, reflecting a strategic focus on key projects [53][55]. - The company reported a net cash inflow of £6.87 million for the year, compared to a net outflow of £4.30 million in 2024, indicating improved financial management [62][65]. - Administrative costs increased to £4.84 million, driven by professional fees and foreign exchange movements [56]. Market Potential - The global GIST market is valued at approximately $1.3 billion, with an expected growth rate of 6-10% annually through 2032, driven by rising incidence and new therapeutic options [28]. - There is a significant unmet medical need for GIST patients who develop resistance to existing treatments, positioning MTX240 as a potential solution [27][39]. Strategic Partnerships and Financing - The company entered a License and Collaboration Agreement with Otsuka for MTX240, which includes exclusive global development rights, excluding Japan [38]. - Biodexa secured a $20 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the Phase 3 program for eRapa, contingent on a company match [46][74].

Core Insights - Biodexa Pharmaceuticals has launched a Global Early Access Program for eRapa, aimed at patients with Familial Adenomatous Polyposis (FAP), through a partnership with Tanner Pharma Group [1][2][3] Company Overview - Biodexa Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative treatments for gastrointestinal cancers [1][7] - The company is headquartered in Cardiff, UK, and has a lead development program for eRapa, which is under development for FAP and Non-Muscle Invasive Bladder Cancer [7][11] Product Information - eRapa is an oral capsule formulation of rapamycin (sirolimus), an mTOR inhibitor, which plays a significant role in cellular metabolism, growth, and proliferation [4][8] - The rationale for using eRapa in treating FAP is supported by the over-expression of mTOR in FAP polyps [4][8] Clinical Development - Biodexa has initiated a double-blind, placebo-controlled Phase 3 trial for eRapa, planning to enroll 168 patients across 30 clinical sites in the US and Europe, with a 2:1 randomization of drug to placebo [4] - The Phase 3 program is backed by a $20 million grant from the Cancer Prevention and Research Institute of Texas [4] Market Context - FAP is characterized by a proliferation of polyps in the colon and/or rectum, typically occurring in mid-teens, with no currently approved therapeutic options available [3] - The incidence of FAP is reported to be one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe [3] Strategic Partnership - The partnership with Tanner Pharma Group aims to provide ethical access to eRapa for FAP patients globally, subject to local regulations and funding availability [2][5]

Core Insights - Biodexa Pharmaceuticals has launched a Global Early Access Program for eRapa, aimed at providing this investigational treatment to patients with Familial Adenomatous Polyposis (FAP) through a partnership with Tanner Pharma Group [1][2][3] Group 1: Company Overview - Biodexa Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative treatments for gastrointestinal cancers [1] - The company’s lead development programs include eRapa for FAP and Non-Muscle Invasive Bladder Cancer, MTX240 for Gastrointestinal Stromal Tumors, and tolimidone for type 1 diabetes [7] Group 2: eRapa Details - eRapa is an oral capsule formulation of rapamycin, an mTOR inhibitor, which plays a significant role in cellular metabolism, growth, and proliferation [4][8] - The drug has received Orphan Designation in the US, with plans to seek similar designation in Europe, and is based on the rationale that mTOR is over-expressed in FAP polyps [3][4] Group 3: Early Access Program - The Early Access Program will allow clinicians globally to prescribe eRapa to appropriate FAP patients, subject to local regulations and funding availability [2] - Biodexa aims to generate Real World Data to enhance understanding of the challenges faced by FAP patients [2] Group 4: Clinical Trials - A double-blind, placebo-controlled Phase 3 trial for eRapa is planned, involving 30 clinical sites across the US and Europe, with an enrollment target of 168 patients in a 2:1 randomization [4] - The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas [4] Group 5: Tanner Pharma Group - Tanner Pharma Group is a specialist pharmaceutical services provider that focuses on improving global access to medicines, supporting manufacturers in providing compliant access to innovative treatments [5]

Core Viewpoint - Biodexa Pharmaceuticals PLC has appointed Fiona Sharp as Chief Financial Officer and Company Secretary, promoting her to the Board of Directors, effective immediately [2][4]. Group 1: Leadership Changes - Fiona Sharp has been with Biodexa since December 2019, initially serving as Group Financial Controller, and has expanded her responsibilities to include many CFO duties [3]. - Stephen Stamp will step down from his roles as CFO and Company Secretary but will continue as Chief Executive Officer [4]. Group 2: Company Background - Biodexa Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs [5]. - The company's lead development programs include eRapa for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, tolimidone for type 1 diabetes, and MTX110 for aggressive rare/orphan brain cancer [5]. Group 3: Product Development - eRapa is an oral capsule formulation of rapamycin, an mTOR inhibitor that plays a significant role in cellular metabolism and tumorigenesis [6]. - Tolimidone is a selective inhibitor of Lyn kinase, showing potential as a first-in-class blood glucose modulating agent [6]. - MTX110 is a formulation of panobinostat designed for direct delivery to tumors, bypassing the blood-brain barrier to reduce systemic toxicity [7]. Group 4: Company Capabilities - Biodexa is supported by three proprietary drug delivery technologies aimed at enhancing the bio-delivery and bio-distribution of medicines [8].

Core Viewpoint - Biodexa Pharmaceuticals PLC is convening a General Meeting to propose four resolutions aimed at restructuring its share capital and enhancing its ability to issue new shares [2][6]. Group 1: Resolutions Proposed - The first resolution proposes the subdivision of each issued ordinary share from £0.001 to one ordinary share of £0.00005 and 19 C deferred shares of £0.00005 each [2][5]. - The second resolution seeks authorization for the Directors to allot equity securities up to a nominal value of £476,954.10, expiring at the conclusion of the Annual General Meeting in 2028 [3]. - The third resolution empowers the Directors to allot equity securities for cash without the application of Section 561 of the Companies Act, also expiring at the conclusion of the Annual General Meeting in 2028 [4]. - The fourth resolution aims to approve and adopt new articles of association, replacing the existing ones [5]. Group 2: Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs [7]. - The company's lead programs include eRapa for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, tolimidone for type 1 diabetes, and MTX110 for aggressive rare/orphan brain cancer [7][8][9][10]. - Biodexa utilizes proprietary drug delivery technologies to enhance the bio-delivery and bio-distribution of its medicines [11].

AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON JUNE 6, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Biodexa Pharmaceuticals PLC (Exact name of registrant as specified in its charter) England and Wales 2834 Not Applicable (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (IRS Employer Identification No.) 1 Caspian ...