August 18, 2025 Biodexa Announces Enrolment of First Patients into Pivotal Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP) Opportunity to be First Mover in $7.3Bn Addressable Market 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 pleased to announce the enrolment of the first two patients by the Pan American Center for Onc ...

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 activated the first clinical study site for its Phase 3 Serenta trial targeting familial adenomatous polyposis (FAP), marking a significant milestone in developing a new treatment option for this condition [1][3]. Group 1: Clinical Trial Details - The Serenta trial (NCT06950385) is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety and efficacy of eRapa in individuals diagnosed with FAP [2]. - The first clinical site in the US is now open and actively screening eligible participants for the trial [2]. Group 2: Company Achievements and Support - Biodexa's CEO, Stephen Stamp, highlighted the importance of the first clinical site activation following the Fast Track Designation and a positive Type C Meeting, emphasizing the collaborative efforts with Emtora Biosciences and LumaBridge [3]. - The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded $20 million in grant funding to support the eRapa program, showcasing significant financial backing for the initiative [3][6]. Group 3: Background on Familial Adenomatous Polyposis (FAP) - FAP is a rare inherited disorder characterized by the development of hundreds to thousands of colorectal polyps, with a near-100% lifetime risk of colorectal cancer if untreated [4]. - There is a significant unmet need for effective and less invasive therapies for FAP patients, as current standard care involves active surveillance and surgical resection [4]. Group 4: About eRapa - eRapa is a proprietary oral formulation of rapamycin (sirolimus), an mTOR inhibitor, which plays a crucial role in regulating cellular metabolism, growth, and proliferation [5][8]. - The formulation is designed to improve bioavailability and reduce toxicity associated with existing rapamycin forms, with patent protection extending through 2035 [5][11].

Core Viewpoint - Biodexa Pharmaceuticals PLC has announced the recruitment of the first patient in a Phase 2 study of tolimidone for Type 1 Diabetes, indicating progress in its clinical development pipeline [2][3]. Group 1: Study Details - The Phase 2 study is an Investigator Initiated Trial (IIT) conducted by the University of Alberta Diabetes Institute, focusing on measuring C-peptide levels and HbA1c after three months in 12 patients across three dose groups [3]. - The study aims to assess the number of hyperglycemic events and may expand in the future [3]. Group 2: Drug Background - Tolimidone was originally discovered by Pfizer and developed through Phase II for gastric ulcers but was discontinued due to lack of efficacy [5]. - It is a selective activator of Lyn kinase, which enhances insulin signaling by increasing phosphorylation of insulin substrate-1 [5][8]. - Preclinical studies at the University of Alberta have shown tolimidone's potential to induce beta cell proliferation, which is crucial for insulin production [4]. Group 3: Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including tolimidone for Type 1 Diabetes [6]. - The company's other lead programs include eRapa for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, and MTX110 for aggressive rare/orphan brain cancer [6].

Core Viewpoint - Biodexa Pharmaceuticals PLC is providing an update on its financial position and the progress of its eRapa Phase 3 program, which targets Familial Adenomatous Polyposis (FAP) and highlights the significant market opportunity for its innovative treatments [2][3][7]. Financial Position - As of May 29, 2025, the company had cash resources totaling $10.1 million, which includes $5.7 million in cash at bank and $4.4 million in escrow for the eRapa Phase 3 program. Additionally, there is an undrawn CPRIT grant of $11.9 million for the same program, and the company has a debt of $0.5 million. The company projects sufficient working capital to fund operations into the first quarter of 2026 [3]. Issued Shares and Market Capitalization - The total number of ordinary shares outstanding as of May 29, 2025, is 50,506,308,922, equivalent to 5,050,630 American Depositary Shares (ADSs). The market capitalization based on the closing share price of $1.06 per ADS is approximately $5.4 million [4]. eRapa Phase 3 Program - The Phase 3 study of eRapa for FAP is in the final stages of implementation, involving a double-blind placebo-controlled trial with 168 patients, randomized in a 2:1 ratio of drug to placebo. The study will take place across approximately 30 clinical sites in the US and Europe, with recruitment expected to begin shortly [5]. About FAP - Familial Adenomatous Polyposis (FAP) is characterized by the proliferation of polyps in the colon and/or rectum, typically starting in mid-teens. There are currently no approved therapeutic options for FAP patients, making the development of eRapa particularly significant [6]. Market Opportunity - The addressable market for eRapa in FAP is estimated at approximately $7.3 billion, based on the lowest prevalence estimates in the US and Europe, with adult populations of approximately 258 million and 358 million, respectively. The median annual cost of approved non-biologic orphan drugs in the US is $206,176 [7]. About eRapa - eRapa is a proprietary oral tablet formulation of rapamycin (sirolimus), an mTOR inhibitor. It is designed to improve bioavailability and reduce toxicity associated with existing forms of rapamycin. Phase 2 study results indicated eRapa was safe and well-tolerated, showing a median 17% reduction in total polyp burden at 12 months compared to baseline [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].

Core Viewpoint - Biodexa Pharmaceuticals has received an additional $3.0 million grant from CPRIT, bringing the total funding for the eRapa Phase 3 program to $20.0 million, aimed at treating familial adenomatous polyposis (FAP) [1][2]. Group 1: Grant and Funding - The additional grant from CPRIT will facilitate the inclusion of more clinical sites and accelerate patient recruitment for the eRapa Phase 3 program [2]. - CPRIT has awarded a total of $2.9 billion in grants to Texas research institutions, supporting various research programs and generating over $5.7 billion in additional investments [2]. Group 2: eRapa Phase 3 Program - The Phase 3 study of eRapa in FAP will involve 168 patients in a double-blind placebo-controlled trial, with a 2:1 randomization of drug to placebo [3]. - The study is expected to be conducted across approximately 30 clinical sites in the US and Europe, with recruitment anticipated to begin in the coming weeks [3]. Group 3: Familial Adenomatous Polyposis (FAP) - FAP is characterized by the proliferation of polyps in the colon and/or rectum, typically starting in mid-teens, with no approved therapeutic options currently available [4]. - 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 hereditary component [4]. Group 4: Market Opportunity - The combined addressable market for eRapa in FAP is estimated at approximately $7.3 billion, based on the lowest prevalence estimates and the adult populations in the US and Europe [5]. Group 5: About eRapa - eRapa is an oral tablet formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing forms of rapamycin [6][7]. - Data from the Phase 2 study indicated eRapa was safe and well-tolerated, showing a median 17% reduction in total polyp burden at 12 months compared to baseline [7].

Financial Risks - The company is exposed to various financial risks, including market risk, credit risk, and liquidity risk, with a focus on minimizing adverse effects on financial performance [686]. - The total exposure to credit risk is equal to the total value of financial assets held at year-end, with a loss allowance for expected credit losses recognized [689]. - The company does not hold any derivative instruments that expose it to material interest rate risk [694]. - Liquidity risk arises from the management of working capital, with the aim to settle balances as they become due [695]. Financing Needs - The company has a $35.0 million Equity Line of Credit (ELOC) with an investor, which may be utilized for financing over a period of up to 36 months [698]. - Future financing will be required before Q4 2025 to support ongoing development programs and operations [698]. - Cash flow forecasts indicate that further financing will be necessary to meet operational needs [698]. - The company acknowledges that the environment for financing small and micro-cap biotech companies remains challenging, which may present acquisition opportunities [698]. Going Concern - There is a material uncertainty regarding the ability to continue as a going concern, as highlighted by the independent registered public accounting firm's report [699]. - The company’s ability to continue operations depends on obtaining additional capital or disposing of assets, with no assurance of timely or favorable terms [700]. ADR and Tax Obligations - ADR holders must pay any taxes or governmental charges related to their Depositary Shares or ADRs [714]. - The depositary has the right to deduct unpaid taxes from cash distributions or sell deposited securities to cover tax obligations [714]. - ADR holders agree to indemnify the depositary and its agents against claims from governmental authorities regarding taxes and penalties [715].

Core Viewpoint - Biodexa Pharmaceuticals PLC reported its preliminary results for the year ended December 31, 2024, highlighting its focus on developing innovative biopharmaceutical products for unmet medical needs, with significant advancements in its clinical pipeline, particularly eRapa, tolimidone, and MTX110 [3][10]. Company Overview - Biodexa Pharmaceuticals PLC is a clinical-stage biopharmaceutical company headquartered in Cardiff, UK, focusing on innovative treatments for diseases with unmet medical needs, including Familial Adenomatous Polyposis (FAP), Non-Muscle Invasive Bladder Cancer (NMIBC), Type 1 Diabetes (T1D), and rare/orphan brain cancers [3][10]. Development Pipeline - The company has transitioned from a drug delivery focus to a therapeutics company, with a pipeline of clinical-stage assets including eRapa, tolimidone, and MTX110, which are expected to improve patient outcomes [11][13]. - eRapa is a proprietary oral formulation of rapamycin, currently in Phase 2 studies for FAP and NMIBC, with plans for a Phase 3 study in FAP expected to recruit approximately 168 patients [18][19]. - Tolimidone, a Lyn kinase activator, is being developed for T1D, with a Phase 2a study planned to confirm dosing in T1D patients [22][23]. - MTX110, designed for direct-to-tumor administration, is in Phase I development for aggressive brain cancers, including glioblastoma and diffuse midline glioma [24][26]. Financial Performance - In 2024, the company reported no gross revenue, a decrease from £0.38 million in 2023, primarily due to the cessation of collaboration agreements [56][58]. - Research and development expenditure increased by 34% to £5.44 million, reflecting investments in clinical-stage assets [60]. - The company experienced a net cash outflow of £4.30 million for the year, compared to an inflow of £3.14 million in 2023, indicating ongoing financial challenges [66][68]. Financing Activities - Biodexa raised a total of $11.1 million from financings in May and July 2024, and secured a $17 million grant from the Cancer Prevention and Research Institute of Texas to support eRapa development [12][49]. - The company entered into an Equity Line of Credit (ELOC) for up to $35 million to support its development programs [72][83]. Regulatory and Compliance - eRapa received FDA Fast Track designation in February 2025, indicating its potential to address significant unmet medical needs in FAP [38]. - The company regained compliance with NASDAQ listing requirements after addressing a previous delisting notification [69].

Core Insights - Biodexa Pharmaceuticals announced a successful Type C meeting with the FDA regarding the Phase 3 program for eRapa in familial adenomatous polyposis (FAP) [1][2] - The Phase 3 study is substantially funded by a $17.0 million grant from CPRIT and an $8.5 million company match [1][3] 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 [7][11] - eRapa is a proprietary oral formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing rapamycin formulations [4][8] Phase 3 Study Details - The planned Phase 3 study will be a double-blind placebo-controlled trial involving 168 patients, randomized in a 2:1 ratio of drug to placebo, conducted across approximately 30 clinical sites in the US and Europe [3][4] - The US component will be managed by LumaBridge, while the European component will be conducted by Precision for Medicine LLC [3] Regulatory Pathway - The Type C meeting followed a productive End of Phase 2 meeting and discussions on the statistical plan, safety database, and composite endpoint for the Phase 3 study [2][4] - The agreement on the composite endpoint allows the company to finalize the protocol and begin patient recruitment in the US [4] Clinical Data - Phase 2 data showed eRapa to be safe and well-tolerated, with a median 17% reduction in total polyp burden at 12 months and a 75% non-progression rate overall [4][8] - In cohort 2, patients experienced an 89% non-progression rate and a 29% median reduction in polyp burden at 12 months [4]