June 25, 2025 Biodexa Announces Activation of First Clinical Study Site for Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP) 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 activation of the first clinical study site for its Serenta trial in patients with familial adenomatous polyposis (FAP). The tria ...

Tolimidone was originally discovered by Pfizer Inc. ("Pfizer") and was developed through Phase II for the treatment of gastric ulcers. Pfizer undertook a broad pre-clinical program to characterize the pharmacology, pharmacokinetics, metabolism and toxicology of tolimidone. Pfizer discontinued development of the drug due to lack of efficacy for that indication in a Phase 2 clinical trial. Tolimidone is a selective activator of the enzyme Lyn kinase which increases phosphorylation of insulin substrate -1, the ...

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].

May 22, 2025 Biodexa Pharmaceuticals PLC(“Biodexa” or the “Company”) Notice of General Meeting Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs announces a Notice of a General Meeting to be held at the Company’s offices, 1 Caspian Point, Caspian Way, Cardiff, CF10 4DQ on 11 June 2025 at 1.00pm was posted to shareholders today. The Board of Directors is proposing four res ...

May 22, 2025 Biodexa Announces Award of Additional $3.0M Grant from CPRIT to Support Registrational eRapa Phase 3 Program in FAP Brings Total CPRIT Grant Funding for eRapa Phase 3 Program to $20.0M 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, today announced its collaboration partner, Rapamycin Holdings, Inc. d/b/a Emtora Biosciences (“Em ...

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]

Core Viewpoint - Biodexa Pharmaceuticals is advancing its clinical development of eRapa for Familial Adenomatous Polyposis (FAP) by appointing Precision for Medicine as the CRO for the European component of a Phase 3 study, which is set to begin next quarter [1][2]. Group 1: Study Details - The Phase 3 study of eRapa will be a double-blind placebo-controlled trial involving 168 patients, with a randomization ratio of 2:1 for drug versus placebo [2]. - The study is expected to take place at approximately 30 clinical sites across the US and Europe [2]. Group 2: Company Background - 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 conditions [5]. - The company is headquartered in Cardiff, UK, and is listed on NASDAQ under the ticker BDRX [5][9]. Group 3: eRapa Overview - eRapa is a proprietary oral formulation of rapamycin, an mTOR inhibitor, which plays a significant role in regulating cellular metabolism and is over-expressed in FAP polyps [4][6]. - The formulation aims to improve bioavailability and reduce toxicity associated with existing rapamycin products [4]. Group 4: Precision for Medicine - Precision for Medicine, appointed as the CRO, specializes in rare diseases and has conducted 333 clinical trials, employing over 700 staff across 11 locations in Europe [3].

Core Points - Biodexa Pharmaceuticals PLC has received allowance for a U.S. patent covering its oral rapamycin nanoparticle preparations, known as eRapa, which is set to issue on March 4, 2025, and is expected to expire in March 2034 [1] - The company plans to initiate a Phase 3 registrational study of eRapa in Familial Adenomatous Polyposis (FAP) in the next quarter, with substantial funding from a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT) [2] - eRapa is a proprietary oral formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity associated with existing rapamycin formulations [2][5] Company Overview - Biodexa is a clinical stage biopharmaceutical company focused on developing innovative products for diseases with unmet medical needs, with lead programs including eRapa for FAP and non-muscle invasive bladder cancer, tolimidone for type 1 diabetes, and MTX110 for aggressive rare brain cancers [4][8] - The company is headquartered in Cardiff, UK, and utilizes proprietary drug delivery technologies to enhance the bio-distribution of its medicines [8] Funding and Research Impact - CPRIT has awarded $2.9 billion in grants to Texas research institutions, supporting significant advancements in cancer research and prevention, which includes funding for Biodexa's Phase 3 study [3] - The funding from CPRIT has generated over $5.7 billion in additional public and private investment, highlighting the importance of such grants in advancing scientific knowledge and clinical applications [3]