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 ...

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 ...

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].