Core Insights - Biodexa Pharmaceuticals PLC announced positive Phase 2 clinical trial results for eRapa™ in treating Familial Adenomatous Polyposis (FAP), with an overall 83% non-progression rate at six months and a statistically significant 24% reduction in polyp burden (p=0.04) [2][6][7] Company Overview - 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 treatments for type 1 diabetes and rare brain cancers [12][13] Clinical Trial Details - The Phase 2 study was an open-label trial conducted across seven U.S. centers, involving 30 adult patients with a median age of 43 years, assessing safety, tolerability, and polyp burden changes over a 12-month treatment period [4][5] - Patients were divided into three dosing cohorts, with the primary endpoints being safety and percentage change in polyp burden at six months [5] Results Summary - At six months, 78% of patients in the duodenum and 86% in the colorectum were classified as non-progressors, with a significant number showing partial response [6][7] - Only two drug-related Grade 3 Serious Adverse Events were reported, and 97% of patients remained on treatment at the six-month mark [6][7] About eRapa - eRapa is a proprietary oral formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing rapamycin formulations [8][14] - The drug has received Orphan Designation in the U.S. and plans to seek similar designation in Europe, targeting a significant unmet need in FAP treatment [9] Funding and Support - The study received partial funding of $20 million from the Cancer Prevention and Research Institute of Texas, which has invested significantly in cancer research and prevention initiatives [3][10]

April 30, 2024 Biodexa Pharmaceuticals PLC(“Biodexa” or the “Company”) Biodexa’s Licensor Emtora to Announce Phase 2 Clinical Trial Results of eRapa™ in Familial Adenomatous Polyposis to be Presented at Prestigious 2024 Digestive Disease Week Annual Meeting Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce that’s its licensor E ...

April 30, 2024 Biodexa Pharmaceuticals PLC("Biodexa" or the "Company") Biodexa's Licensor Emtora to Announce Phase 2 Clinical Trial Results of eRapa™ in Familial Adenomatous Polyposis to be Presented at Prestigious 2024 Digestive Disease Week Annual Meeting Biodexa Pharmaceuticals PLC, (NASDAQ:BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce that's its licensor Em ...

Oncology specialist Biodexa (NASDAQ:BDRX) soared on Friday as the company disclosed the entering of an exclusive worldwide license to develop and commercialize a key therapeutic. Fundamentally, the announcement sent BDRX stock flying up about 70% in the late afternoon session as the drug addresses a disease for which there are no approved therapeutic options.According to a Seeking Alpha report, Biodexa inked a deal with Rapamycin Holdings, which does business as Emtora Biosciences. The licensing centers on ...

April 26, 2024 Biodexa Pharmaceuticals PLC("Biodexa" or the "Company") Biodexa Enters Into Exclusive License to eRapa™, a Phase 3 Ready Asset for theTreatment of Familial Adenomatous Polyposis (FAP) Worldwide rights come with $17 million in non-dilutive grant funding for Pivotal Phase 3 trial in FAP An estimated 100,000 in U.S. and Europe are afflicted with FAP, precancerous polyps that typically lead to surgical removal of the colon and/or rectum In FAP, eRapa holds the potential of delaying or preventin ...

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 [726]. - The total exposure to credit risk is equal to the total value of financial assets held at year-end, with a loss allowance recognized for expected credit losses [729]. - The company aims to settle financial obligations as they become due, indicating a proactive approach to managing liquidity risk [734]. - The company does not hold any derivative instruments that expose it to material interest rate risk [733]. - The company does not enter into derivatives to manage credit risk, relying instead on high credit status banks for cash and cash equivalents [728]. - The company retains some cash balances in US Dollars to mitigate foreign exchange exposure related to its NASDAQ listing and US-based clinical studies [732]. Going Concern and Financing - Future viability depends on the ability to raise cash from financing activities, with a warning that failure to secure additional funding before Q4 2024 could jeopardize going concern status [735][737]. - The company acknowledges that the environment for financing small biotech companies remains challenging, which may present acquisition opportunities but could also lead to dilution [738]. - An explanatory paragraph regarding material uncertainty about the company's ability to continue as a going concern was included in the independent auditor's report for the year ended December 31, 2023 [739]. - The company has prepared cash flow forecasts for the next three years, indicating that further financing will be required within the next 12 months [737]. Internal Control and Disclosure - As of December 31, 2023, the company's disclosure controls and procedures were effective at a reasonable level of assurance [760]. - The management assessed the effectiveness of internal control over financial reporting as of December 31, 2023, concluding it was effective [763]. - There were no changes in internal control over financial reporting during the fiscal year ended December 31, 2023, that materially affected the internal control environment [764].

AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON MARCH 18, 2024 Registration No. 333- (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) 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) England and Wales 2834 Not Applicable (IRS Employer Identification No.) Caspian ...

Biodexa Pharmaceuticals PLC("Biodexa" or the "Company") Biodexa Announces Positive Top Line Phase I Clinical Trial Results for Diffuse Midline Glioma and Provides R&D Update Median Overall Survival of 16.5 Months vs 10.0 months in Comparable Cohort CARDIFF, United Kingdom, February 23, 2024 (GLOBE NEWSWIRE) – 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 including Type ...

Biodexa Pharmaceuticals PLC Biodexa Reports 12 Month Survival in MAGIC-G1 Study of MTX110 in Recurrent Glioblastoma Patients CARDIFF, United Kingdom, February 8, 2024 (GLOBE NEWSWIRE) -- 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 including Type 1 diabetes and rare/orphan brain cancers, today provided survival updates from its MAGIC-G1 stu ...

Biodexa Pharmaceuticals PLC Biodexa Announces Allowance of U.S. Patent Covering Tolimidone Biodexa plans to initiate a Phase 2 clinical program of tolimidone in Type 1 diabetes, following several preclinical studies demonstrating its role in beta cell survival Safety profile established in prior human studies of more than 700 patients CARDIFF, United Kingdom, February 7, 2024 (GLOBE NEWSWIRE) -- Biodexa Pharmaceuticals PLC ("Biodexa" or the "Company")(NASDAQ:BDRX), a clinical stage biopharmaceutical company ...