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. ...

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]

Financial Performance - Revenue for both periods was £Nil, as the last of the company's R&D collaborations concluded in September 2023[31]. - The Group incurred a consolidated loss from operations of £3.81 million in 1H25, compared to £3.31 million in 1H24[40]. - For the six months ended June 30, 2025, the Group incurred a consolidated loss from operations of £3.81 million, compared to a loss of £3.31 million in the same period of 2024[57]. - Basic and diluted loss per share for 1H25 was £(0.0002), compared to £(0.001) in 1H24, with a significant increase in the weighted average number of ordinary shares used in the calculation[70]. Research and Development (R&D) Costs - R&D costs decreased to £1.67 million in 1H25, down 24% from £2.19 million in 1H24, reflecting a reduction in spending on the MAGIC-G1 study[6]. - R&D costs represented 41% of operating costs in 1H25, down from 52% in 1H24[31]. - R&D costs in 1H25 decreased by £0.52 million, or 24%, to £1.67 million compared to £2.19 million in 1H24, with R&D costs as a percentage of total operating costs dropping to 41% from 52%[33]. - The Group recognized R&D costs of £0.5 million for the FAP project in 1H25, up from £0.2 million in 1H24, with total expenditure of £2.6 million netted against a CPRIT grant of £2.1 million[65]. Cash Flow and Financing - Net cash used in operating activities in 1H25 was £3.30 million, an improvement from £4.81 million in 1H24[6]. - Cash outflows from operating activities in 1H25 were £3.30 million, an improvement from £4.81 million in 1H24, driven by a net loss of £3.81 million[36]. - The company achieved a net cash inflow of £2.37 million for the period, compared to a net outflow of £0.92 million in 1H24[31]. - Net cash generated from financing activities in 1H25 was £6.01 million, up from £4.65 million in 1H24, primarily due to £6.20 million proceeds from share issuances[38]. - Overall cash increased by £2.37 million in 1H25, resulting in a cash balance of £4.04 million as of June 30, 2025[39]. - As of June 30, 2025, the Group had cash and cash equivalents of £4.04 million, indicating a need for further financing before the second quarter of 2026[60]. - The Directors believe there are adequate options to secure additional financing, although the environment for financing small biotech companies remains challenging[44]. - The requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt on the Group's ability to continue as a going concern[45]. - The Directors believe there are adequate options and time available to secure additional financing, despite the challenging environment for small and micro-cap biotech companies[61]. Assets and Liabilities - As of June 30, 2025, the Group had an accumulated deficit of £154.13 million[40]. - As of June 30, 2025, the Group's accumulated deficit stood at £154.13 million[57]. - The Group's total assets as of June 30, 2025, were £14.82 million, with total liabilities of £3.39 million[48]. - As of June 30, 2025, the total share capital and reserves amounted to £13,935,391, compared to £11,724,988 as of December 31, 2024, indicating an increase of approximately 19%[73]. Share Capital and Structure - The company has 61,952,308,922 ordinary shares of £0.000001 each authorized and fully paid as of June 30, 2025[73]. - The company has 17,415 pre-funded warrants outstanding over ADSs, which are recognized in the warrant reserve until exercise[75]. - The company’s issued ordinary shares were subdivided and redesignated on June 11, 2025, into one ordinary share of £0.000001 each and 49 'D' deferred shares of £0.000001 each[74]. - The 'D' deferred shares have limited rights and are effectively valueless[74]. - The total number of 'C' deferred shares as of June 30, 2025, was 126,547,389,518, valued at £6,327,370[73]. - The company’s total authorized share capital includes various classes of shares, with 'D' deferred shares totaling 2,482,747,137,178[73]. Regulatory and Legal Matters - The company received Orphan Drug Designation for eRapa in FAP from the European Commission in May 2025[3]. - The first patients were enrolled in the pivotal Serenta trial of eRapa in FAP in August 2025[5]. - The company is in a dispute with a former advisor over fees, with a potential liability of approximately $1.16 million, of which $0.82 million would be payable in cash[77]. - On July 15, 2025, the company announced a ratio change on its ADSs from one ADS representing 10,000 ordinary shares to one ADS representing 100,000 ordinary shares, effective July 31, 2025[78].

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 Viewpoint - Biodexa Pharmaceuticals PLC Unsponsored ADR (BDRX) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is primarily driven by changes in a company's earnings picture, with the Zacks Consensus Estimate reflecting EPS estimates from sell-side analysts [2]. - The recent upgrade for Biodexa Pharmaceuticals suggests an improvement in its earnings outlook, which could lead to increased buying pressure and a rise in stock price [4][6]. Impact of Earnings Estimate Revisions - There is a strong correlation between changes in earnings estimates and near-term stock price movements, with institutional investors using these estimates to determine fair value [5][7]. - Biodexa Pharmaceuticals has seen a 90% increase in its Zacks Consensus Estimate over the past three months, indicating a positive trend in earnings expectations [9]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of generating significant returns for top-rated stocks [8][10]. - The upgrade to Zacks Rank 2 places Biodexa in the top 20% of Zacks-covered stocks, suggesting it is well-positioned for potential market-beating returns in the near term [11].

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]

Core Viewpoint - Biodexa Pharmaceuticals PLC has announced a change in the ratio of its American Depositary Receipts (ADR), effective July 31, 2025, which will convert one ADR from representing 10,000 ordinary shares to representing 100,000 ordinary shares [2][3]. Group 1: ADR Ratio Change - The ratio change will function as a one-for-ten reverse ADR split for existing ADR holders, with the exchange occurring automatically [3]. - The previous ADRs will be cancelled, and new ADRs will be issued by JPMorgan Chase Bank, N.A., the depositary bank for the company's ADR program [3]. Group 2: Total Voting Rights - The total number of issued ordinary shares of Biodexa will remain unchanged at 61,952,308,922 shares following the ratio change [4]. - After the ratio change, there will be 619,523 ADRs outstanding [4].

Core Viewpoint - Biodexa Pharmaceuticals has filed a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) for its Phase 3 Serenta trial 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 conditions [2][11]. - The company has received Fast Track Designation from the FDA and Orphan Drug designation in Europe for its eRapa program [4]. Clinical Trial Details - The Serenta trial (NCT06950385) is a randomized, double-blind, placebo-controlled Phase 3 study aimed at evaluating the safety and efficacy of eRapa in FAP patients [5]. - The trial will initially cover clinical sites in Denmark, Germany, Netherlands, and Spain, with Italy expected to be added later [3]. Funding and Support - The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded $20 million in grant funding to support the eRapa program [4]. - CPRIT has a history of significant investment in cancer research, having awarded $2.9 billion in grants to date [9]. Disease Context - Familial adenomatous polyposis (FAP) is characterized by the development of hundreds to thousands of colorectal polyps, leading to a near-100% lifetime risk of colorectal cancer if untreated [7]. - There is a significant unmet need for effective therapies for FAP, as current treatment options primarily involve surgical resection [7]. Product Information - eRapa is a proprietary oral formulation of rapamycin (sirolimus), an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing formulations [8][12]. - The product is protected by multiple patents extending through 2035, with additional applications pending [8].