January 05, 2026 Biodexa Pharmaceuticals PLC Appointment of Fiona Sharp to the Board as Chief Financial Officer and Company Secretary Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is delighted to announce the promotion of Fiona Sharp to Chief Financial Officer and Company Secretary along with her election to the Board of Directors of the ...

Core Viewpoint - Biodexa Pharmaceuticals PLC has announced a public offering priced at $10 million, aimed at funding its development programs and general corporate purposes [2][3]. Offering Details - The offering consists of 157,000 ADS Units, each comprising one American depositary share (representing 100,000 ordinary shares) and two Series L warrants [2]. - Additionally, there are 2,891,781 Pre-Funded Units, each consisting of one pre-funded warrant to purchase one ADS and two Series L Warrants [2]. - The public offering price for each ADS Unit is set at $3.28, while each Pre-Funded Unit is priced at $3.2799 [2]. Financial Proceeds - The expected gross proceeds from the offering, before deducting fees and expenses, are approximately $10 million [3]. - The net proceeds will be utilized for development programs, working capital, and other corporate purposes [3]. Closing and Agent Information - The offering is anticipated to close on December 19, 2025, pending customary closing conditions [4]. - Maxim Group LLC is acting as the sole placement agent for this offering [4]. 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]. Product Details - eRapa is an oral formulation of rapamycin, an mTOR inhibitor involved in cellular metabolism and tumorigenesis [8]. - Tolimidone is a selective inhibitor of Lyn kinase, showing potential for glycaemic control in diabetes [9]. - MTX110 is a formulation of panobinostat designed for direct delivery to tumors, bypassing the blood-brain barrier [10][11].

Registration No. 333-291598 As filed with the U.S. Securities and Exchange Commission on December 11, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO 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 Em ...

Core Viewpoint - Biodexa Pharmaceuticals has initiated the enrollment of the first three patients in Europe for its pivotal Phase 3 Serenta trial of eRapa, targeting familial adenomatous polyposis (FAP), a hereditary condition that significantly increases the risk of colorectal cancer if untreated [2][4]. Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and other products for various conditions [2][9]. Trial Details - The Serenta trial (NCT06950385) is a double-blind, placebo-controlled study involving 168 patients, with a randomization ratio of 2:1 for drug versus placebo, aimed at evaluating the safety and efficacy of eRapa in FAP patients [4]. - The trial has identified all study sites and is onboarding additional European sites in the Netherlands, Spain, Denmark, and Italy, with nine more expected to activate in the next 2-3 months [4]. - The trial is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas [4]. Disease Context - Familial adenomatous polyposis (FAP) is a rare inherited disorder leading to the development of numerous colorectal polyps and a near-100% lifetime risk of colorectal cancer if untreated, with a prevalence of 1 in 5,000 to 10,000 in the US and 1 in 11,300 to 37,600 in Europe [5]. - Current treatment options for FAP are limited, primarily involving surgical resection, highlighting the need for effective and less invasive therapies [5]. Product Information - eRapa is an oral capsule formulation of rapamycin (sirolimus), an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing rapamycin formulations [6][10]. - The rationale for using eRapa in FAP treatment is supported by the over-expression of mTOR in FAP polyps, indicating its potential effectiveness [6]. Funding and Support - The Cancer Prevention and Research Institute of Texas has awarded $2.9 billion in grants to support cancer research, with a total investment of $6 billion approved by Texas voters for cancer research and prevention [7].

Core Insights - Biodexa Pharmaceuticals has activated its first European site for the Phase 3 Serenta clinical trial evaluating eRapa in familial adenomatous polyposis (FAP), marking a significant milestone in expanding treatment options for European patients [1][2] Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative products for diseases with unmet medical needs, including eRapa for FAP and other therapies for type 1 diabetes and rare brain cancers [7] Clinical Trial Details - The Serenta trial is a randomized, double-blind, placebo-controlled study designed to assess the efficacy of eRapa in preventing disease progression in FAP patients, who face a near-100% risk of colorectal cancer by age 50 if untreated [3][4] - The trial began enrolling patients in the US in August 2025, with nine additional European sites expected to activate in the next 2-3 months across the Netherlands, Spain, Denmark, and Italy [3] Treatment Context - FAP is a rare inherited disorder characterized by the development of numerous colorectal polyps, leading to a significant unmet need for effective, less invasive therapies, as current standard care involves surgical resection [4] - eRapa, a proprietary oral formulation of rapamycin, is an mTOR inhibitor that targets the over-expression of mTOR in FAP polyps, providing a rationale for its use in treatment [5][8] Funding and Support - The advancement of the Serenta trial has been supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas, alongside collaborations with Emtora Biosciences and Precision for Medicine [2][6]

As filed with the U.S. Securities and Exchange Commission on November 17, 2025. 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) (State or Other Jurisdiction of Incorporation or Organization) England and Wales 2834 Not Applicable (Primary Standard Industrial Classification Code Number) (IRS Employer Identification No. ...

Core Viewpoint - Biodexa Pharmaceuticals has received approval from the European Medicines Agency (EMA) for a Clinical Trial Application (CTA) to initiate the Phase 3 Serenta trial for eRapa in patients with familial adenomatous polyposis (FAP), targeting a significant unmet medical need in a $7 billion market [2][5]. Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and other programs for type 1 diabetes and rare brain cancers [10][14]. Clinical Trial Details - The Serenta trial is a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of eRapa in FAP patients, with an expected enrollment of 168 patients in a 2:1 drug to placebo ratio [5]. - The trial will initially take place in Denmark, Germany, the Netherlands, and Spain, with Italy expected to be added later [3][4]. Market Potential - The addressable market for FAP treatment is estimated at $7 billion, highlighting the significant opportunity for Biodexa to be a first mover in this space [5]. Disease Background - Familial adenomatous polyposis (FAP) is a rare inherited disorder that leads to a near-100% lifetime risk of colorectal cancer if untreated, with no approved therapeutic options currently available [7]. - The prevalence of FAP is reported to be between 1 in 5,000 to 10,000 in the US and 1 in 11,300 to 37,600 in Europe, indicating a significant need for effective treatments [7]. Product Information - eRapa is an oral formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing forms of rapamycin [8][11].

Core Insights - Biodexa Pharmaceuticals PLC is hosting a breakfast symposium on "FAP mechanisms and Chemoprevention Trial Issues" at the CGA-IGC annual meeting in St Louis, MO from October 9-11, 2025 [2][3] - The symposium will feature Dr. Patrick Lynch as the guest speaker and will include an interactive panel discussion with experts from the University of Chicago and Washington University [3] - The event is significant for Biodexa as it coincides with the advancement of its Phase 3 Serenta trial for eRapa, aimed at addressing unmet medical needs in Familial Adenomatous Polyposis (FAP) [4] Company Overview - Biodexa is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and Non-Muscle Invasive Bladder Cancer, tolimidone for type 1 diabetes, and MTX110 for aggressive rare/orphan brain cancers [5] - eRapa is a proprietary oral formulation of rapamycin, an mTOR inhibitor, which plays a crucial role in cellular metabolism and tumorigenesis [6] - Tolimidone is a selective activator of Lyn kinase, showing potential for glycaemic control in diabetes [7] - MTX110 is a formulation of panobinostat designed for direct delivery to tumors, bypassing the blood-brain barrier [8] Research and Development Focus - The symposium reflects Biodexa's collaborative research approach and the growing scientific interest in advancing treatment options for FAP [4] - The Phase 3 Serenta trial represents a critical opportunity for Biodexa to potentially provide the first approved therapy for FAP patients, who currently have limited treatment options [4]

Core Insights - Biodexa Pharmaceuticals PLC reported its interim results for the six months ended June 30, 2025, highlighting significant operational and financial developments in its clinical pipeline and financial management [2][5][28]. Operational Highlights - The US Patent and Trademark Office granted a patent for "Oral Rapamycin Nanoparticle Preparations and Use," exclusively licensed to the company [4]. - Precision for Medicine, LLC was appointed to conduct the European component of the Phase 3 study of eRapa in Familial Adenomatous Polyposis (FAP) [4]. - The company successfully held a Type C meeting with the FDA regarding the protocol for the Phase 3 study of eRapa in FAP [4]. - eRapa received Orphan Drug Designation from the European Commission for FAP [4]. - The first patient was recruited in a Phase 2a study of tolimidone for Type 1 Diabetes [4]. - The company launched a dedicated website for the Serenta trial of eRapa in FAP [4]. - The first clinical study site for the Serenta trial was activated in the US [4]. - A Clinical Trial Application was filed with the European Medicines Agency for the Serenta trial [4]. - The company signed a $35 million Equity Line of Credit with C/M Capital Master Fund LP [4]. - Emtora Biosciences, a collaboration partner, received an additional grant of $3 million, totaling $20 million in non-dilutive funding for the Phase 3 program of eRapa in FAP [4]. Financial Highlights - R&D costs decreased to £1.67 million in 1H25 from £2.19 million in 1H24, reflecting a 24% reduction [10][32]. - Administrative costs increased to £2.38 million in 1H25 from £2.03 million in 1H24, driven by a foreign exchange charge [33]. - Net cash used in operating activities was £3.30 million in 1H25, down from £4.81 million in 1H24 [35]. - The company's cash balance at June 30, 2025, was £4.04 million [38]. - The company reported a consolidated loss from operations of £3.81 million in 1H25, compared to a loss of £3.31 million in 1H24 [55]. Research and Development Update - The company advanced its R&D pipeline, moving eRapa in FAP into Phase 3 and tolimidone for Type 1 Diabetes into Phase 2 [7]. - eRapa is a proprietary oral formulation of rapamycin, designed to improve bioavailability and reduce toxicity [9]. - The Phase 3 study of eRapa in FAP is a double-blind, placebo-controlled trial recruiting 168 high-risk patients [14]. - The ongoing Phase 2 study in Non-muscle Invasive Bladder Cancer is fully enrolled with 166 patients [16]. Financing Activities - The company raised gross proceeds of £8.56 million from the Equity Line of Credit as of June 30, 2025 [27]. - The company experienced a net cash inflow of £2.37 million in 1H25, compared to a net outflow of £0.92 million in 1H24 [38].

Core Insights - Biodexa Pharmaceuticals has enrolled the first two patients in its pivotal Phase 3 Serenta trial for eRapa, targeting familial adenomatous polyposis (FAP), a hereditary condition that significantly increases the risk of colorectal cancer [2][3] - The company aims to be the first mover in a $7.3 billion addressable market for FAP treatments, with eRapa being the only drug candidate currently in Phase 3 trials [3][8] Company Overview - Biodexa Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and other products for different conditions [2][10] - The company has received $20 million in grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the Serenta trial [3][9] Trial Details - The Serenta trial is a double-blind, placebo-controlled study involving 168 patients, with a randomization ratio of 2:1 for drug versus placebo [5] - The trial will be conducted across multiple sites, including 20 in the US and 10 in Europe, managed by LumaBridge and Precision for Medicine, respectively [5] Disease Context - Familial adenomatous polyposis (FAP) is characterized by the development of numerous colorectal polyps and a near-100% lifetime risk of colorectal cancer if untreated, highlighting the urgent need for effective therapies [6] - Current treatment options are limited to surgical interventions, underscoring the significance of developing non-surgical alternatives like eRapa [4][6] Market Opportunity - The estimated addressable market for eRapa in FAP is approximately $7.3 billion, based on prevalence rates and the median annual cost of approved non-biologic orphan drugs [8]