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 Insights - Biodexa Pharmaceuticals 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][2] - 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) [1][2] - eRapa is designed to improve the bioavailability and reduce toxicity associated with existing forms of rapamycin, leveraging nanotechnology and pH-sensitive polymers [2][5] 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 programs targeting type 1 diabetes and aggressive rare brain cancers [4][8] - The company has a proprietary oral tablet formulation of rapamycin, which acts as an mTOR inhibitor, targeting pathways involved in cellular metabolism and tumorigenesis [2][5] Funding and Support - CPRIT has awarded a total of $2.9 billion in grants to Texas research institutions, supporting cancer research and prevention initiatives, which includes funding for Biodexa's Phase 3 study [3] - The funding from CPRIT is matched by Biodexa's contributions of $8.5 million, demonstrating a strong commitment to advancing cancer treatment research [2]

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]

Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative products for diseases with unmet medical needs [6] - The company is listed on NASDAQ under the ticker BDRX [6] Upcoming Conference - Biodexa has been invited to present at the Emerging Growth Conference on February 19, 2025, at 09:40 AM Eastern time for a duration of 30 minutes [1][3] - The presentation will be led by CEO/CFO Stephen Stamp, who will also engage with the audience for questions [2] Product Pipeline - The company's lead development programs include: - eRapa, an oral tablet formulation of rapamycin for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer [6][7] - Tolimidone, a selective inhibitor of Lyn kinase for type 1 diabetes treatment [6][8] - MTX110, a formulation of the HDAC inhibitor panobinostat for aggressive rare/orphan brain cancer [6][9] Drug Delivery Technologies - Biodexa utilizes three proprietary drug delivery technologies aimed at enhancing the bio-delivery and bio-distribution of its medicines [10]

Core Insights - Biodexa Pharmaceuticals has received Fast Track designation from the US FDA for eRapa, a treatment for familial adenomatous polyposis (FAP), highlighting the urgent need for alternatives to surgical intervention [1][2] Group 1: eRapa and Its Development - eRapa is a proprietary encapsulated form of rapamycin, designed to address the unmet medical need for FAP, a condition that can lead to colorectal cancer if untreated [1][2] - The Phase 2 study of eRapa demonstrated a median 17% reduction in total polyp burden at 12 months compared to baseline, with a 75% non-progression rate overall [2] - In cohort 2 of the study, patients experienced an 89% non-progression rate and a 29% median reduction in polyp burden at 12 months, with a preferred dosing regimen of daily every other week for the upcoming Phase 3 study [2] Group 2: Familial Adenomatous Polyposis (FAP) - FAP is characterized by a proliferation of polyps in the colon and/or rectum, typically beginning in the mid-teens, with no approved therapeutic options currently available [3] - The prevalence of FAP is reported to be one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe, indicating a significant hereditary component [3] Group 3: Mechanism and Technology - eRapa functions as an mTOR inhibitor, which plays a crucial role in cellular metabolism, growth, and proliferation, and is over-expressed in FAP polyps [4][8] - The formulation of eRapa utilizes nanotechnology and pH-sensitive polymers to improve bioavailability and reduce toxicity associated with existing rapamycin forms [4] Group 4: 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 programs targeting type 1 diabetes and rare brain cancers [7]

Management Team Strengthening - Biodexa Pharmaceuticals PLC appointed Dr Gary A Shangold as Chief Medical Officer effective immediately [2] - Dr Shangold brings extensive experience across all phases of drug development in multiple therapeutic areas [4] - He previously served as Chief Medical Officer at Enteris BioPharma and Xanodyne Pharmaceuticals, and as CEO of NovaDel Pharma [4] - Dr Shangold holds an MD from Columbia University and completed residency and fellowship programs in Obstetrics & Gynecology and Reproductive Endocrinology [5] - He has approximately 10 years of experience in clinical and regulatory affairs at Johnson & Johnson's R W Johnson Pharmaceutical Research Institute [5] Company Overview - Biodexa is a clinical-stage biopharmaceutical company developing innovative products for diseases with unmet medical needs [8] - The company's lead development 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 cancers [8] - Biodexa utilizes three proprietary drug delivery technologies to improve bio-delivery and bio-distribution of medicines [12] - The company is headquartered in Cardiff, UK with an R&D facility [12] Product Pipeline - eRapa is an oral tablet formulation of rapamycin, an mTOR inhibitor that regulates cellular metabolism, growth, and proliferation [9] - Tolimidone is an oral Lyn kinase inhibitor that demonstrates glycemic control via insulin sensitization in animal models of diabetes [10] - MTX110 is a solubilized formulation of panobinostat, delivered via convection-enhanced delivery directly to tumor sites, bypassing the blood-brain barrier [11][12] Leadership Commentary - CEO Stephen Stamp emphasized the importance of Dr Shangold's expertise as Biodexa advances to later clinical stages, including a global Phase 3 registrational study in FAP [3] - Dr Shangold's previous experience includes securing two NDAs at Xanodyne Pharmaceuticals [3]

Core Viewpoint - Biodexa Pharmaceuticals Plc is under investigation for potential claims related to its securities following the release of concerning clinical trial data for its drug MX110, which has led to a significant drop in its stock price [1][2]. Investigation Details - On October 4, 2024, Biodexa reported updated data from a Phase 1 study of MX110 for recurrent glioblastoma, revealing that out of four patients in Cohort A, two have died, with overall survival times of 12 and 13 months for the remaining patients [2]. - Following this announcement, Biodexa's stock price decreased by $0.45, or 7.5%, closing at $5.55 per share on the same day [2]. Next Steps - Investors who have information related to the investigation or who purchased Biodexa securities are encouraged to assist by visiting the law firm's website [3]. Legal Representation - Bronstein, Gewirtz & Grossman, LLC operates on a contingency fee basis, meaning they will only seek reimbursement for expenses and attorney fees if they are successful in the case [4]. Firm Background - Bronstein, Gewirtz & Grossman, LLC is a recognized firm specializing in representing investors in securities fraud class actions and has successfully recovered hundreds of millions of dollars for investors [5].