November 24, 2025 Biodexa Activates First European Site for Registrational Phase 3 Serenta Trial in FAP Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) announced today that the University of Bonn, Germany is now actively screening patients for the Phase 3 Serenta clinical trial evaluating eRapa in familial adenomatous polyposis (FAP). This marks the first European site activation for the registrational Serenta trial, representing a major milestone in expanding FAP treatment options to European patients who curr ...

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].

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, contributing to the advancement of the trial [4][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 and less invasive therapies for FAP patients, 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 potentially providing further protection [8].