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Investor releaseQuarter not tagged2026-03-28Preliminary Results for the Year Ended 31 December 2025
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Preliminary Results for the Year Ended 31 December 2025
March 27, 2026 Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company” or, together with its subsidiaries, the “Group”) Preliminary Results for the Year Ended 31 December 2025 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical-stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers, announces its audited preliminary results for the year ended 31 December 2025. For more information, please contact: Biodexa Pharmaceuticals PLC Stephen Stamp, CEO Fiona Sharp, CFO Tel: +44 (0)29 2048 0180 www.biodexapharma.com About Biodexa The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, MTX240 under development for Gastrointestinal Stromal Tumors (GIST) and tolimidone, under development for the treatment of type 1 diabetes. eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signaling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. MTX240 is a molecular glue, bringing two intracellular proteins, PDE3a and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT signaling. Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com. Forward-Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on managemen…Read full documentShow less
March 27, 2026 Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company” or, together with its subsidiaries, the “Group”) Preliminary Results for the Year Ended 31 December 2025 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical-stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers, announces its audited preliminary results for the year ended 31 December 2025. For more information, please contact: Biodexa Pharmaceuticals PLC Stephen Stamp, CEO Fiona Sharp, CFO Tel: +44 (0)29 2048 0180 www.biodexapharma.com About Biodexa The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, MTX240 under development for Gastrointestinal Stromal Tumors (GIST) and tolimidone, under development for the treatment of type 1 diabetes. eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signaling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. MTX240 is a molecular glue, bringing two intracellular proteins, PDE3a and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT signaling. Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com. Forward-Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising. INTRODUCTION Headquartered in Cardiff, UK, Biodexa is a NASDAQ listed biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers including Familial Adenomatous Polyposis (“FAP”) and Gastro Intestinal Stromal Tumors (“GIST”). Until last year, the Company had been developing MTX110 for rare/orphan brain cancers but, due to resource constraints, these programs have been de-prioritized and removed from the R&D pipeline. STRATEGY The Company’s transition from a drug delivery company to a higher value therapeutics company was completed in 2025. With the in-licensing of MTX240 from Otsuka Pharmaceutical Co., Limited (“Otsuka”) in February 2026, our pipeline is increasingly focused on gastrointestinal and oncology programs. All of our pipeline of assets are at clinical stage and, we believe, offer significant potential to improve outcomes for patients. Our priorities for 2026 are as follows: BUSINESS MODEL Having successfully broadened our internal pipeline, our business model is to add value to our development programs by advancing them through the clinic before seeking partners to complete late-stage studies and commercialize the products. Development Our intention is to build a balanced portfolio of clinical-stage development assets, ideally with a focus on gastrointestinal and oncology indications. eRapa was in-licensed in April 2024 and is undergoing a registrational Phase 3 trial in FAP together with an ongoing Phase 2 study in NMIBC. MTX240 was in-licensed in February 2026 as Phase 1 ready for GIST. Tolimidone, which was in-licensed in December 2023, is in Phase 2a and is being developed initially for T1D. Manufacturing We do not intend to establish our own manufacturing capabilities. For clinical trial supplies we utilize GMP-certified contract manufacturers. Commercialization Once proof-of-concept has been established, we intend to out-license our products to a partner who would complete the clinical development and subsequently market and sell them in the licensed territory. In addition to reimbursement of development costs, the partner would be expected to make milestone payments based on sales targets and royalty payments. Because the Phase 3 program for eRapa in FAP is substantially funded by a grant from CPRIT and an escrowed company match, commercialization of eRapa in FAP by the Company remains an option. Our development pipeline now includes four projects, all which are at clinical stage, as follows: CLINICAL-STAGE ASSETS eRapa eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signaling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis1. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune® (Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. Familial Adenomatous Polyposis (FAP) FAP is characterized as a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teenage years. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US2 and one in 11,300 to 37,600 in Europe3. eRapa has received Orphan Designation in the US and Europe. Importantly, mTOR has been shown to be over-activated in FAP polyps, thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. eRapa received FDA Fast Track designation in February 2025. The results of the Phase 2 study were presented at two leading scientific conferences in the second quarter of 2024. Following a positive Type C meeting with the FDA, the protocol for a registrational Phase 3 trial was finalized. The Phase 3 trial, branded “Serenta”, is a multi-center, double-blind, placebo-controlled study in high risk patients diagnosed with FAP. The study plans to recruit 168 patients randomized 2:1 drug:placebo across 30 or more sites in the US and Europe, with a primary endpoint being time to a defined progression free survival event. Quality of life measures will also be captured. The study is expected to recruit over 18 months and is supported by a non-dilutive grant of $20.0 million from CPRIT. Non-muscle Invasive Bladder Cancer (NMIBC) NMIBC refers to tumors found in the tissue that lines the inner surface of the bladder. The most common treatment is transurethral resection of the bladder tumor followed by intravesical Bacillus Calmette-Guerin (“BCG”) with chemotherapy depending upon assessment of risk of recurrence. NMIBC is the fourth most common cancer in men with an incidence of 10.1 per 100,000 in men and 2.5 per 100,000 in women4. An ongoing double-blind, placebo-controlled Phase 2 Investigator Initiated Trial (“IIT”) in NMIBC is fully enrolled at 166 patients with primary endpoints of safety/tolerability and relapse free survival after 12 months of treatment. The Phase 2 study is supported by a $2.8 million non-dilutive grant from the National Cancer Institute, part of the National Institutes of Health. MTX240 MTX240, discovered by Otsuka and originally coded OPB-171775, is a novel molecular glue we intend to develop initially for the treatment of GIST. MTX240’s molecular glue activity brings together two intracellular proteins, PDE3A and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT or PDGFR signaling. GIST is mostly driven by activating mutations in the KIT or PDGFR receptor tyrosine kinase. Although tyrosine kinase inhibitors (“TKIs”) such as imatinib, sunitinib, and regorafenib have significantly improved outcomes for GIST patients, resistance almost always develops through secondary KIT or PDGFR mutations or activation of alternative signaling pathways. This represents a substantial clinical challenge with limited therapeutic options for patients once they have cycled through the available TKIs. Molecular glue technology represents a novel approach that induces targeted protein interactions, offering a distinct mechanism of action to conventional tyrosine kinase inhibitors for GIST and by triggering cell death through an alternative MAPKinase pathway. MTX240 is designed to overcome the resistance mechanisms that render TKI-resistant GISTs refractory to conventional TKIs. Gastrointestinal Stromal Tumors (GIST) GIST is a rare gastrointestinal malignancy with approximately 6,000 diagnosed patients annually in the US5, with a significant unmet medical need for patients who develop TKI resistance. Approximately 10-15%. of GIST patients are either primarily refractory, or develop secondary resistance to available TKIs whereupon options for these patients remain limited. The global GIST market is valued at approximately $1.3 billion and is expected to grow at 6-10% annually through 20326, driven by rising incidence and emerging therapeutic options targeting treatment-resistant disease. GIST qualifies for orphan drug designation in major regulatory jurisdictions, offering potential regulatory advantages and incentives to support drug development. Tolimidone Tolimidone was originally discovered by Pfizer Inc. (“Pfizer”) and was developed through Phase 2 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 Phase 2a. Tolimidone is a selective activator of the enzyme Lyn kinase which increases phosphorylation of insulin substrate -1, thereby amplifying the signaling cascade initiated by the binding of insulin to its receptor. Type 1 Diabetes (T1D) In T1D, the body’s immune system attacks pancreatic beta cells such that they can no longer produce insulin which is required to regulate plasma glucose levels. The causes of T1D are not fully understood and there is currently no cure. Patients with T1D are dependent on daily administration of insulin (via injection or infusion). We are developing tolimidone for the treatment of T1D. As a Lyn kinase activator, tolimidone has been shown in preclinical experiments to have a role in beta cell survival and proliferation. If replicated in clinical studies, tolimidone could have the potential to be disease modifying and change the treatment paradigm for T1D. T1D affects approximately 8.4 million people worldwide and there are approximately 500,000 new diagnoses per annum7. CHIEF EXECUTIVE’S REVIEW Introduction In 2025, our primary focus was the successful initiation of the Phase 3 Serenta trial of eRapa in FAP. Considerable effort was also expended on due diligence and negotiation of the Licensing and Collaboration Agreement for MTX240 which was signed in early February 2026. R&D update eRapa We in-licensed eRapa, a proprietary formulation of rapamycin, from Rapamycin Holdings, Inc. d/b/a Emtora Biosciences, Inc. (“Emtora”) in April 2024. We made considerable progress with our Phase 3 program for eRapa in FAP during 2025 and achieved a number of important milestones as set out below. In March 2025 we announced the appointment of Precision for Medicine, LLC (“Precision”) as the CRO to manage the European component of our Phase 3 trial. With over 20 years of experience, Precision’s reputation is founded on its high-caliber, therapeutically specialized staff, experienced scientists and physicians, advanced specialty laboratories, and problem-solving capabilities. Precision has conducted 333 clinical trials in rare diseases and employs over 700 team members in Europe across 11 locations. Also, in March 2025 we reported that we had a productive Type C meeting with the FDA which included a discussion of the statistical plan, the safety database and, most importantly, a composite endpoint for the Phase 3 Serenta trial. FDA representatives from both Gastroenterology and Oncology Divisions provided valuable input into the proposed program, providing a clear path forward for finalization of the protocol. Following initiation of the first US clinical site in June 2025, the first US patient was enrolled in August 2025. In November 2025 we received approval from the EMA for our Clinical Trial Application for the Phase 3 trial and the first European patient was enrolled in December 2025. As of 16 March, there were 22 active clinical sites and 37 patients enrolled in the Serenta study. Other milestones achieved in 2025 included the receipt of Fast Track designation from FDA and Orphan Drug Designation from the EMA. The Phase 3 study is expected to take approximately 18 months to recruit all 168 patients and database lock will occur after 75 events which is expected to be in the second half of 2029. An ongoing double-blind, placebo-controlled Phase 2 IIT of eRapa in NMIBC has enrolled all 166 patients and is expected to read out in the third quarter of 2026. MTX240 In February 2026 we announced that we had entered into a License and Collaboration Agreement with Otsuka for MTX240. Under the terms of the license agreement we have exclusive rights to develop and commercialize MTX240 globally with the exception of Japan where Otsuka retains its rights. The agreement included a modest upfront fee and provides for one additional development milestone and low double-digit approval milestones. In addition, tiered royalties in the mid-single digit range are payable on net sales of MTX240. As a molecular glue, MTX240 has a unique mechanism of action compared with tyrosine kinase inhibitors, the current standard of care for GIST, all of which can eventually lose efficacy through continued mutation. MTX240’s novel mechanism may provide clinical benefit for a significant proportion of GIST patients, not only those who have developed resistance to TKIs. In patient derived xenograft (PDX) models, MTX240 has shown dose-dependent anti-tumor efficacy in imatinib and sunitinib resistant models irrespective of KIT mutation status. MTX240 benefits from composition of matter patents in the US, Europe, Japan and various other countries extending through 2037 excluding any patent term extension. Our first step is to manufacture clinical trial supplies of MTX240 and then initiate an open-label Phase 1b/2a study by year-end. The study is expected to be in two parts: a standard dose escalation part to determine a maximum tolerated dose followed by an extension part. The extension part is likely to enroll patients with TKI-resistant GIST. By focusing on this high-need population, we are aiming to rapidly validate MTX240’s potential to treat patients who do not, or no longer, respond to the current standard of care. Tolimidone In December 2023 we secured the global rights to develop and commercialize tolimidone. The product is supported by very substantial preclinical data, has been exposed to more than 700 patients and has demonstrated compelling preclinical data to support our chosen indication of T1D. As a first step in the planned continued clinical development of tolimidone, we initiated a Phase 2a dose confirmation IIT at the University of Alberta, Diabetes Institute with the first patient enrolled in June 2025. The Phase 2a study is open-label and is expected to enroll approximately 15 patients with T1D treated with tolimidone for three months with endpoints of change in C-peptide levels, HbA1c and number of hyperglycemic events. MTX110 Due to resource constraints, the MTX110 rare/orphan brain cancer programs were not funded in 2025 and, accordingly, have been removed from our development pipeline. Financings Promissory Note In December 2024 we issued an unsecured promissory note to C/M Capital Master Fund LP in the principal amount of $600,000 with a 10% original issue discount. The Note was an unsecured obligation with interest of 5% pa. and was fully repaid in December 2025. Equity Line of Credit (ELOC) In January 2025, we entered into a three-year $35.0 million ELOC with C/M Capital Master Fund, LP. During calendar 2025 we used the ELOC to raise approximately $8.9 million in gross proceeds. CPRIT grant In May 2025 we announced CPRIT had awarded an additional grant of $3.0 million, bringing the total to $20.0 million, to support the Phase 3 program of eRapa in FAP. Receipt of funds is conditional upon a 1:1 company match. Registered Offering In December 2025 we closed a registered offering of ADSs and pre-funded warrants at $3.28 per ADS to raise gross proceeds of $10.0 million. We also issued 6.10 million Series L warrants exercisable at $3.28 over five years. Further details of financings are included in “Financial Review”. Outlook Our primary focus for 2026 will be two-fold: first, continued acceleration of enrolment of patients in our registrational Phase 3 Serenta trial in the US and Europe and by adding additional countries and sites and second, manufacture of clinical supplies and initiation of a Phase 1b/2a study of MTX240 in GIST. As has been the case for the past few years, financing for small- and micro-cap biotech companies remains challenging. The $10.0 million registered offering in December 2025 extends our runway into 3Q26 and the $35.0 million ELOC we put in place in February 2025 provides a potential backstop source of capital. 1 Tian et al., mTOR Signaling in Cancer and mTOR Inhibitors in Solid Tumor Targeting Therapy, Int J Mol Sci. 2019 Feb; 20(3): 755 2 www.rarediseases.org 3. www.orpha.net 5 Zhu, H., et al. (2023). Update of epidemiology, survival and initial treatment in gastrointestinal stromal tumor: A population-based analysis. BMJ Open, 13(7), e072945. https://doi.org/10.1136/bmjopen-2023-072945 6 DataBridge Market Research. (2023). Gastrointestinal stromal tumor market size, trends and forecasts (2024-2032). Retrieved from https://www.databridgemarketresearch.com/reports/global-gastrointestinal-stromal-tumor-market 7 Medicina Apr 2023 FINANCIAL REVIEW Introduction Biodexa Pharmaceuticals PLC was incorporated as a company on 12 September 2014 and is domiciled in England and Wales. Financial analysis Key performance indicators Revenue Revenue for both periods was £Nil. The last of the Company’s R&D collaborations concluded in September 2023. Research and development expenditure R&D costs analyzed by development project indication were as follows: MTX230 eRapa Familial Adenomatous Polyposis costs are shown above net of grant income. This is analyzed as follows: Research and development costs were £3.96 million, a reduction of £1.48 million, or 27% on 2024 (2024: £5.44 million). The percentage of R&D costs as a percentage of operating costs reduced to 45% from 59% in the prior year. The reduction in R&D costs in 2025 predominately reflects a reduction in spend of £0.71 million on pre-clinical studies and manufacturing costs on MTX228, £0.60 million on the MTX110 MAGIC-G1 study in rGBM and £0.44 million on MTX230 eRapa (net of CPRIT grant income). The percentage of MTX230 (eRapa) costs that were able to be offset against grant funding during the period was 77% compared to 43% in 2024. We anticipate that over the life of the grant this will be 67%. Administrative costs Administrative costs in the year increased by £1.04 million to £4.84 million (2024: £3.79 million), an increase of 27%. The increase in administrative costs in the year is driven by foreign exchange movement of £0.44 million, an increase in professional fees of £0.73 million offset by a reduction in share-based payments of £0.10 million. In 2025 the Company expensed £1.72 million on legal and professional fees in connection with the successful financing transaction in December, the acquisition of the Otsuka license completed in 2026 and aborted acquisitions, and £0.37 million non- cash upfront commitment fee for the ELOC, this compares to £0.88m spent in 2024 on similar transactions. Staff costs During the year, the average number of staff decreased to 11 (2024: 13). Total staff cost increased 1% to £2.17 million (2024: £2.15 million), driven by the increase in wages and salaries of £0.14 million. Finance income and expense Finance income in 2025 and 2024 included gains in respect of an equity settled derivative financial liability of £2.30 million (2024: £3.22 million). The gains arose as a result of the fall in the Biodexa share price. In addition, the Company earned interest on cash deposits. Finance expense in the 2024 and 2025 related to lease liabilities, discounted interest on deferred consideration and interest on the promissory note issued in December 2024. Taxation During 2025 and 2024 we recognized U.K research and development tax credits of £0.11 million and £0.25million in respect of R&D expenditure incurred. Capital expenditure Purchase of tangible fixed assets in 2025 was £2,000 (2024: £0.01 million) and related to the purchase of IT equipment. During the year the Company took the decision to de-commission its laboratory in Cardiff and disposed of the majority of its equipment. This is in line with the Company strategy as set out above. Cash flow Net cash outflow from operating activities in 2025 was £5.59 million (2024: outflow £12.26 million) driven by a net loss of £6.38 million (2024: loss £5.73 million) and after positive movements in working capital of £1.72 million (2024: negative £3.74 million), taxes received of £0.71 million (2024: £0.13 million), and other net negative adjustments for non-cash items totaling £1.63 million (2024: negative £2.93 million). Investing activities outflow in 2025 of £0.58 million (2024: outflow of £0.60 million) included purchases of property, plant and equipment of £2,000 (2024: £0.01 million) and payment of deferred consideration on the eRapa license of £0.69 million (2024: £0.77 million). These cash outflows are offset by interest income from bank deposits of £0.09 million (2024: £0.18 million). Financing activities inflow in 2025 of £13.04 million (2024: inflow of £8.56 million) was driven by receipts from share issues of £13.75 million (2024: £8.31 million) from use of the ELOC agreement, proceeds from the warrant inducement in May 2025 and proceeds from the registered offering in December 2025. This is offset by loan repayments (including interest) of £0.46 million and payments on lease liabilities of £0.25 million (2024: £0.19 million). As a result of the foregoing, net cash inflow for the year was £6.87 million (2024: outflow of £4.30 million). Change in ADS Ratio and Nominal Value of Ordinary Shares On 31 July 2025 the Company effected a change in the ratio of the Company’s Ordinary Shares from each ADS representing 10,000 Ordinary Shares to each ADS representing 100,000 Ordinary Shares. At a General Meeting on 11 June 2025, shareholders approved the subdivision and redesignation of the Company’s Issued Ordinary Shares of £0.00005 each into to one Ordinary Share of £0.000001 each and 49 ‘D’ Deferred Shares of £0.000001 each. The ‘D’ Deferred Shares have limited rights and are effectively valueless. On 18 March 2026 the Company announced a change in the ratio of the Company’s Ordinary Shares from each ADS representing 100,000 Ordinary Shares to each ADS representing 500,000 Ordinary Shares. Financings Equity Line of Credit (“ELOC”) In January 2025, we entered into a securities purchase agreement, or equity line of credit (“ELOC”), with the newly formed C/M. Under the terms of the ELOC, we have the right, but not the obligation, to sell to C/M from time to time up to $35 million of newly issued ADSs over a 36-month period, unless the ELOC is terminated. As consideration for the execution and delivery of the ELOC, we agreed to pay a commitment fee (“Commitment Fee”) of $875,000 in cash, of which (i) $612,500 was to be paid to C/M on signing the ELOC and (ii) the balance was to be paid pro rata, simultaneously with the delivery of any ADSs sold under the ELOC. We had the right to issue ADSs representing the value of the applicable portion of the Commitment Fee. We paid the initial Commitment Fee of $612,500 through the issuance of 140,080 Depositary Shares to the Purchaser. We may direct C/M to purchase a specified number of ADSs not to exceed $2.5 million on any given day, at a price based on a formula, typically 95% of the closing price on the prior day. As of 31 December 2025, the Company had raised gross proceeds of $8.92 million from the ELOC. Warrant Inducement In May 2025 we entered into letter agreements with certain holders of outstanding Series E, Series H, Series J and Series K warrants to reduce the exercise price of such warrants to $0.31 per share. The holders exercised an aggregate of 200,433 warrants representing the same number of ADSs. We received gross proceeds of approximately $62,000, before offering expenses. The Company did not issue new warrants to replace the exercised warrants and did not engage a placement agent to facilitate the transaction. Registered Offering In December 2025 we closed a Registered Offering with institutional investors for the sale of (i) an aggregate of 157,000 ADSs and (ii) an aggregate of 2,891,781 pre-funded warrants exercisable for Depositary Shares at a price per Depositary Share of $3.28 and a price per pre-funded warrant of $3.2799. The pre-funded warrants were exercisable immediately. In addition, we also issued and sold to investors Series L Warrants for 6,097,562 Depositary Shares at an exercise price of $3.28 per Depositary Share. The Series L Warrants are exercisable immediately and expire five years from the date of issuance. We received gross proceeds of $10 million before deducting placement agent’s fees and related offering expenses. Promissory Note The promissory note issued in December 2024 for $600,000 was fully repaid during the year. CPRIT Grant In May 2025 we announced that our collaboration partner, Emtora, had been awarded an additional grant of $3.0 million from CPRIT. The award brought the total grant awarded by CPRIT to support the registrational Phase 3 program of eRapa in FAP to $20.0 million. Access to the $3.0 million is conditioned on the Company providing a 1:1 match of $3.0 million. Going Concern – material uncertainty The Group and Company has experienced net losses and significant cash outflows from cash used in operating activities over the past years as it develops its portfolio. For the year ended 31 December 2025, the Group incurred a consolidated loss for the year of £6.38 million and negative cash flows from operations of £5.59 million. As of 31 December, 2025, the Group had an accumulated deficit of £155.81 million. The Group’s future viability is dependent on its ability to raise cash from financing activities to finance its development plans until milestones and/or royalties can be secured from partnering the Company’s assets. The Group’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. The Directors believe there are adequate options and time available to secure additional financing for the Company and after considering the uncertainties, the Directors consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements. The Group's consolidated financial statements have therefore been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As at 31 December 2025, the Group had cash and cash equivalents of £8.53 million. The Directors have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of the consolidated financial statements. These forecasts show that further financing will be required in Q3 2026 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. Pursuant to its $35 million Equity Line of Credit, or ELOC, as described above, the Company may direct C/M to purchase ADSs (subject to certain limitations) and receive proceeds in accordance with a formula price. There is no guarantee that the Company will be able to use the ELOC or rase from other financing to the extent necessary to finance the Company’s operations. As at 31 December 2025 $26.08 million remains undrawn from the ELOC. In the Directors’ opinion, the environment for financing of small and micro-cap biotech companies remains challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by Biodexa are likely to be dilutive. The Directors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Group. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any alternative courses of action to finance the Company would be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon the Group and Parent Company’s ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Company which are actionable before its cash resources run out then the Company will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities. Environmental matters, community, human rights issues and employees As at 31 December 2025 the Group had 11 employees, of whom 4 were routinely based at its offices in Cardiff, Accordingly the Company believes it has a relatively modest environmental impact. A number of policies and procedures governing expectations of ethical standards and the treatment of employees and other stakeholders are set out in the Company’s Employee Handbook. The Company has also established an anti-slavery policy pursuant to the Modern Slavery Act 2015. The Company strives to be an equal opportunity employer, irrespective of race or gender. At 31 December 2025, the number of male/female employees was 36%/64%, the number of male/female senior managers was 57%/43% and the number of male/female Directors was 80%/20%. Annual greenhouse gas emissions We measure our environmental performance by reporting our carbon footprint in terms of tonne CO2 equivalent. We report separately on our indirect emissions from consumption of electricity (Scope 2) and emissions consisting of employee travel in cars on Group business estimated on the basis of miles travelled (Scope 3). The Group have elected to monitor and report its energy efficiency using tonnes of CO2 per employee as an intensity ratio. Methodology In calculating the reported energy usage and equivalent greenhouse gas emissions the Group have referred to the HM Government Environment Reporting Guidelines and the GHG Reporting Protocol. A location-based allocation methodology was used to calculate electricity usage. The Group’s electricity costs for 2025 were approximately £16,000 (2024: £25,000). The kWh usage in the year was 54,380 (2024: 81,933). The Group has no immediate plans to improve energy efficiency. CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME For the year ended 31 December The notes form an integral part of these consolidated financial statements. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION At 31 December The notes form an integral part of these consolidated financial statements. CONSOLIDATED STATEMENTS OF CASH FLOWS For the year ended 31 December CONSOLIDATED STATEMENTS OF CASH FLOWS(CONTINUED) For the year ended 31 December The notes form an integral part of these consolidated financial statements. CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY For the year ended 31 December CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY(CONTINUED) NOTES FORMING PART OF THE FINANCIAL STATEMENTS For the year ended 31 December 2025 1. Basis of preparation The consolidated financial statements have been prepared in accordance with international accounting standards in conformity with the requirements of the Companies Act 2006, and they are prepared in accordance with international financial reporting standards. The consolidated financial statements have been prepared on a historical cost basis except that the following assets and liabilities are stated at their fair value: certain financial assets and financial liabilities measured at fair value, and liabilities for cash-settled share-based payments. The financial information contained in this final announcement does not constitute statutory financial statements as defined in Section 435 of the Companies Act 2006. The financial information has been extracted from the financial statements for the year ended 31 December 2025 which have been approved by the Board of Directors, and the comparative figures for the year ended 31 December 2024 and 31 December 2023 are based on the financial statements for that year. The financial statements for 2024 and 2023 have been delivered to the Registrar of Companies and the 2025 financial statements will be delivered after the Annual General Meeting. The auditor’s report for the Company’s 2025 Annual Report and Accounts was unqualified but did draw attention to the material uncertainty relating to going concern. The auditor’s report did not contain statements under s498(2) or (3) of the Companies Act 2006. Whilst the financial information included in this results announcement has been prepared in accordance with International Financial Reporting Standards (IFRSs) this announcement does not itself contain sufficient information to comply with IFRSs. The information in this results announcement was approved by the board on 27 March 2026. Going concern – material uncertainty The Group and Company has experienced net losses and significant cash outflows from cash used in operating activities over the past years as it develops its portfolio. For the year ended 31 December 2025, the Group incurred a consolidated loss for the year of £6.38 million and negative cash flows from operations of £5.59 million. As of 31 December 2025, the Group had an accumulated deficit of £155.81 million. The Group’s future viability is dependent on its ability to raise cash from financing activities to finance its development plans until milestones and/or royalties can be secured from partnering the Company’s assets. The Group’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. The Directors believe there are adequate options and time available to secure additional financing for the Company and after considering the uncertainties, the Directors consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements. The Group's consolidated financial statements have therefore been presented on a going concern basis, which contemplates the realisation of assets and the satisfaction of liabilities in the normal course of business. As at 31 December 2025, the Group had cash and cash equivalents of £8.53 million. The Directors have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of the consolidated financial statements. These forecasts show that further financing will be required in Q3 2026 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. Pursuant to its $35 million Equity Line of Credit, or ELOC, as described in the Finance Review, the Company may direct C/M to purchase ADSs (subject to certain limitations) and receive proceeds in accordance with a formula price There is no guarantee that the Company will be able to use the ELOC or raise from other financing to the extent necessary to finance the Company’s operations. As at 31 December 2025 $26.08 million remains undrawn from the ELOC. In the Directors’ opinion, the environment for financing of small and micro-cap biotech companies remains challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by Biodexa are likely to be dilutive. The Directors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Group. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any alternative courses of action to finance the Company would be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon the Group and Parent Company’s ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Company which are actionable before its cash resources run out then the Company will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities. Accounting for rRapa and CPRIT grant On 25 April 2024 the Company entered into a License and Collaboration Agreement (LCA) with Rapamycin Holdings, Inc. (d/b/a Emtora Biosciences). The LCA entered into with Emtora meets the definition of a Joint Arrangement under IFRS 11, specifically related to the FAP program. A jointly controlled escrow account was established on completion of the LCA. FAP program transactions eligible to be allocated against the CPRIT grant and match funding are processed through the escrow account, including the Company’s deposits of matching funds, as set out in the agreement, the receipt of grant funding from CPRIT and the payment of eligible R&D expenses. Although the CPRIT grant and R&D supplier contracts are with Emtora, the joint arrangement nature of the LCA results in Emtora being deemed to be acting as the Company’s agent. Accordingly, the Company recognises 100% of the grant and 100% of the R&D expenditure. The CPRIT grant recognised is on a 1 for 2 match basis for the first $17 million, the final $3 million is recognised on a 1 for 1 basis. In accordance with the Company’s accounting policy, the grant, as it is the re-imbursement of directly related costs, is credited to R&D costs in the same period in the Statements of Comprehensive Income. The escrow account is recognised within prepayments, CPRIT grant received in advance is recognised within deferred revenue and any grant not yet received is recognised in accrued income. The balances as at 31 December were as follows in relation to the FAP project: * prepayment reflects only the escrow account balance 2. Finance income and expense 3. Loss per share At a General Meeting on 1 June 2025, shareholders approved the subdivision and redesignation of the Company’s Issued Ordinary Shares of £0.00005 each into to one Ordinary Share of £0.000001 each and 49 ‘D’ Deferred Shares of £0.000001 each. The ‘D’ Deferred Shares have limited rights and are effectively valueless. The share sub-division and redesignation did not impact the calculation of the denominator as the number of Issued Ordinary Shares did not change. During the year the Company issued warrants that were accounted through the Warrant Reserve. The Company has considered the guidance set out in IAS 33 in calculating the denominator in connection with the issuance of Pre-Funded warrants. Management have recognised the warrants from the date of grant rather than the date of issue of the corresponding Ordinary Shares when calculating the denominator. The Group has made a loss in the current and previous periods presented, and therefore the options and warrants are anti-dilutive. As a result, diluted loss per share is presented on the same basis as basic loss per share. 4. Share capital At a General Meeting on 11 June 2025, shareholders approved the subdivision and redesignation of the Company’s Issued Ordinary Shares of £0.00005 each into to one Ordinary Share of £0.000001 each and 49 ‘D’ Deferred Shares of £0.000001 each. The ‘D’ Deferred Shares have limited rights and are effectively valueless. On 31 July 2025 the Company effected a ratio change in the number of Ordinary Shares represented by ADSs from 10,000 Ordinary Shares per ADS to 100,000 Ordinary Shares per ADS. In accordance with the Articles of Association for the Company adopted on 11 June 2025, the share capital of the Company consists of an unlimited number of ordinary shares of nominal value £0.000001 each. Ordinary and deferred shares were recorded as equity. 5. Related party transactions The Directors consider there to be no related party transactions during the periods reported other than Directors Remuneration. 6. Events after the reporting date On February 4, 2026, the Company announced that it had entered into a license and collaboration agreement (the “License Agreement”) with Otsuka Pharmaceutical Co., Ltd. (“Otsuka”), pursuant to which Otsuka granted the Company an exclusive, worldwide (excluding Japan) license (the “Licensed Territory”) to develop manufacture and commercialize OPB-171755, to be designated MTX240 (“MTX240”), a Phase 1-ready molecular glue therapeutic candidate, for all human therapeutic uses. The Company intends to initially develop MTX240 for the treatment of gastrointestinal stromal tumors. Pursuant to the License Agreement, the Company will be responsible for all development, manufacturing and commercialization activities for MTX240 in the Licensed Territory, and Otsuka will retain all rights to MTX240 in Japan. As consideration for the license, the Company made an upfront payment to Otsuka, and Otsuka is eligible to receive one-time development and regulatory milestones, as well as tiered royalties in the mid-single digits on the net sales of licensed products. The Company is also obligated to pay Otsuka a percentage of any sublicense income it receives, subject to certain exceptions. On 18 March 2026 the Company announced a change in the ratio of the Company’s Ordinary Shares from each ADS representing 100,000 Ordinary Shares to each ADS representing 500,000 Ordinary Shares.
Investor releaseQuarter not tagged2025-09-12Interim results for the six months ended June 30, 2025
GlobeNewswire
Interim results for the six months ended June 30, 2025
September 12, 2025 Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) Interim results for the six months ended June 30, 2025 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, today announces its unaudited interim results for the six months ended June 30, 2025 which will also be made available on the Company’s website at www.biodexapharma.com. OPERATIONAL HIGHLIGHTS The Company announced the following in the six months ended June 30, 2025: Allowance by the US Patent and Trademark Office of patent application No. 17/391-495 “Oral Rapamycin Nanoparticle Preparations and Use”, exclusively licensed to the Company by Emtora Biosciences . Appointment of Precision for Medicine, LLC as the clinical research organization to conduct the European component of the upcoming registrational Phase 3 study of eRapa in FAP. A successful Type C meeting with the US Food and Drug Administration regarding the protocol for the Company’s registrational Phase 3 study of eRapa in FAP. Orphan Drug Designation granted for eRapa in FAP by the European Commission. Recruitment of the first patient in a Phase 2a study of tolimidone in Type 1 Diabetes in an Investigator Initiated Trial conducted by the University of Alberta Diabetes Institute. Selection of ‘Serenta’ as the brand name for its Phase 3 clinical study of eRapa in FAP together with launch of a dedicated website, www.serentatrial.com, to provide information and resources for patients, caregivers, and healthcare professionals. Activation of the first clinical study site in the US for its Serenta trial in patients with FAP. Post period end: Filing of a Clinical Trial Application with the European Medicines Agency for its Serenta trial in patients with FAP. Enrolment of first patients in the Serenta trial by the Pan American Center for Oncology Trials in San Juan, Puerto Rico. FINANCIAL HIGHLIGHTS Commenting, Stephen Stamp, CEO and CFO, said “The first half was extremely productive. Having secured Fast Track designation and successfully negotiated our way through a Type C meeting with the FDA, in August we enrolled the first patients into our pivotal Serenta trial of eRapa in FAP. In parallel, we secured orphan designation from the European Commission for eRapa in FAP in Europe and filed a Cl…Read full documentShow less
September 12, 2025 Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) Interim results for the six months ended June 30, 2025 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, today announces its unaudited interim results for the six months ended June 30, 2025 which will also be made available on the Company’s website at www.biodexapharma.com. OPERATIONAL HIGHLIGHTS The Company announced the following in the six months ended June 30, 2025: Allowance by the US Patent and Trademark Office of patent application No. 17/391-495 “Oral Rapamycin Nanoparticle Preparations and Use”, exclusively licensed to the Company by Emtora Biosciences . Appointment of Precision for Medicine, LLC as the clinical research organization to conduct the European component of the upcoming registrational Phase 3 study of eRapa in FAP. A successful Type C meeting with the US Food and Drug Administration regarding the protocol for the Company’s registrational Phase 3 study of eRapa in FAP. Orphan Drug Designation granted for eRapa in FAP by the European Commission. Recruitment of the first patient in a Phase 2a study of tolimidone in Type 1 Diabetes in an Investigator Initiated Trial conducted by the University of Alberta Diabetes Institute. Selection of ‘Serenta’ as the brand name for its Phase 3 clinical study of eRapa in FAP together with launch of a dedicated website, www.serentatrial.com, to provide information and resources for patients, caregivers, and healthcare professionals. Activation of the first clinical study site in the US for its Serenta trial in patients with FAP. Post period end: Filing of a Clinical Trial Application with the European Medicines Agency for its Serenta trial in patients with FAP. Enrolment of first patients in the Serenta trial by the Pan American Center for Oncology Trials in San Juan, Puerto Rico. FINANCIAL HIGHLIGHTS Commenting, Stephen Stamp, CEO and CFO, said “The first half was extremely productive. Having secured Fast Track designation and successfully negotiated our way through a Type C meeting with the FDA, in August we enrolled the first patients into our pivotal Serenta trial of eRapa in FAP. In parallel, we secured orphan designation from the European Commission for eRapa in FAP in Europe and filed a Clinical Trial Application with the EMA, which sets us up to begin enrolment in the Serenta trial in Europe in the fourth quarter”. CHIEF EXECUTIVE’S REVIEW Our main focus in the first half of 2025 was on preparatory activities for the start of our registrational Phase 3 trial of eRapa in Familial Adenomatous Polyposis (“FAP”). R&D update In the first half of 2025 we materially advanced our R&D pipeline, moving eRapa in FAP into Phase 3 and tolimidone for Type 1 Diabetes (“T1D) into Phase 2: eRapa eRapa is a proprietary oral formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune®(Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. eRapa is protected by a number of issued patents which extend through 2035, with other pending applications potentially providing further protection beyond 2035. Familial Adenomatous Polyposis (“FAP”) FAP is an orphan indication characterized by a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP almost always leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation in the US and in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. An open-label Phase 2 study (NCT04230499) was conducted by Emtora in seven U.S. centres of excellence in 30 adult patients. Patients were sequentially enrolled into three dosing cohorts of 10 patients each for a 12-month treatment period: 0.5mg every other day (Cohort 1), 0.5mg daily every other week (Cohort 2), and 0.5mg daily (Cohort 3). Upper and lower endoscopic surveillance occurred at baseline and after six months. Primary endpoints were safety and tolerability of eRapa and percentage change from baseline in polyp burden, as measured by the aggregate of all polyp diameters. In May 2024 and June 2024, results of the Phase 2 study at six months and 12 months, respectively, were presented at prestigious scientific meetings by Carol Burke, MD, the Principal Investigator. In summary, at six months, eRapa appeared safe and well-tolerated with a significant 24% reduction in the total polyp burden at six months compared with baseline and an overall 83% non-progression rate. At 12 months, 21 of 28 (75%) patients were deemed to be non-progressors with a median reduction in polyp burden of 17%. In Cohort 2, the dosage regimen for Phase 3, eight of nine (89)% of patients were deemed non-progressors at 12 months with a median reduction in polyp burden of 29%. Over the course of 12 months, there were four related Grade 3 or higher and one related Serious Adverse Event reported during the trial and 95% compliance rate at 12 months. One patient was removed from the trial due to non-compliance. The Phase 3 registrational study (NCT06950385) is a double-blind placebo-controlled design, recruiting 168 high risk patients diagnosed with germline or phenotypic FAP. The primary clinical endpoint is first progression free survival event which will comprise composite endpoints including major surgery. We had a successful ‘Type C’ meeting with the FDA in January 2025 to finalise the protocol. The first clinical site was initiated in June 2025 and the first patients enrolled by the Pan American Center for Oncology Trials in San Juan, Puerto Rico in August 2025. Europe is following closely behind; our contract research organisation, Precision for Medicine, was appointed in March 2025. Orphan Drug Designation for eRapa in FAP was granted by the European Commission in May 2025. A Clinical Trial Application was filed with the European Medicines Agency for the Serenta trial in July 2025 which, if approved, will facilitate the start of patient recruitment in Europe in 4Q25. Non-muscle Invasive Bladder Cancer (“NMIBC”) NMIBC refers to tumors found in the tissue that lines the inner surface of the bladder. The most common treatment is transurethral resection of the bladder tumor followed by intravesical Bacillus Calmette-Guerin (“BCG”) with chemotherapy depending upon assessment of risk of recurrence. NMIBC is the fourth most common cancer in men with an incidence of 10.1 per 100,000 and 2.5 per 100,000 in women. The ongoing multi-centre, double-blind, placebo-controlled Phase 2 study in NMIBC (NCT04375813) is fully enrolled at 166 patients with primary endpoints of safety/tolerability and relapse free survival after 12 months of treatment. The study, which is supported by a $3.0 million non-dilutive grant from the National Cancer Institute, part of the National Institutes of Health, was transferred to the University of Texas, San Antonio as an Investigator Initiated Trial and is expected to read out in mid-2026. MTD228 - Tolimidone Tolimidone was originally discovered by Pfizer and was developed through Phase 2 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. Tolimidone is a selective activator of the enzyme Lyn kinase which increases phosphorylation of insulin substrate-1, thereby amplifying the signalling cascade initiated by the binding of insulin to its receptor. Type 1 Diabetes (“T1D”) Tolimidone’s potential utility in T1D has been demonstrated by several preclinical studies conducted by the University of Alberta, where Lyn kinase was identified as a key factor for beta cell survival and proliferation in in vitro and in vivo models. Most importantly, tolimidone appeared to induce proliferation in beta cells isolated from human cadavers. From a mechanism of action perspective, tolimidone has been shown to both prevent beta cell degradation and to stimulate beta cell proliferation. In a meta analysis of 1,202 articles and 193 studies, the incidence of T1D was shown to be 15 per 100,000 with a prevalence of 9.5 per 10,000 of the population. As a first step in the continued clinical development of tolimidone, a Phase 2a Investigator Initiated Trial (IIT) at the University of Alberta Diabetes Institute (NCT06474598) is designed to establish the minimum effective dose of tolimidone in patients with T1D. The study, enrolled the first patient in June 2025 and is expected to recruit 12 patients initially across three dose groups. The study will measure C-peptide levels (a marker for insulin) and HbA1c (a marker for blood glucose) after three months compared with baseline and the number of hyperglycemic events. MTX110 MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the brain tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. All three types of brain cancer being studied are orphan. Recurrent Glioblastoma (“rGBM”) Our Phase 1 MAGIC-G1 study (NCT05324501) of MTX110 in rGBM has completed the dose escalation part of the study with the recruitment of the fourth patient in Cohort A. Overall survival was reported as between 11 and 12 months. Glioblastoma virtually always recurs with median Progression Free Survival of 1.5–6.0 months and median Overall Survival of 2.0–9.0 months. Diffuse Midline Glioma (“DMG”) In February 2024 we announced headline data from a Phase 1 IIT study conducted by Columbia University in newly diagnosed patients with DMG. As this was the first ever study of repeated infusions to the pons via an implanted CED catheter, the primary objective of the study was safety and tolerability and, accordingly, the number of infusions was limited to two, each of 48 hours, seven days apart in nine patients. One patient suffered a severe adverse event assessed by the investigators as not related to the study drug. Although not powered to reliably demonstrate efficacy, median Overall Survival of patients in the study was 16.5 months compared with median survival rate in a cohort of 316 cases of 10.0 months. Study investigators subsequently presented the results of the trial at the 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) in Philadelphia, PA. Medulloblastoma An IIT Phase I study of MTX110 in medulloblastoma remains ongoing at the University of Texas. Due to resource constraints, MTX110 has been de-prioritised and there are no current development activities being undertaken. Financing Equity Line of Credit In January 2025, we entered into a securities purchase agreement, or equity line of credit (“ELOC”), with the newly formed C/M. Under the terms of the ELOC, we have the right, but not the obligation, to sell to C/M from time to time up to $35 million of newly issued ADSs over a 36-month period, unless the ELOC is terminated. As consideration for the execution and delivery of the ELOC, we agreed to pay a commitment fee (“Commitment Fee”) of $875,000 in cash, of which (i) $612,500 was to be paid to C/M on signing the ELOC and (ii) the balance was to be paid pro rata, simultaneously with the delivery of any ADSs sold under the ELOC. We had the right to issue ADSs representing the value of the applicable portion of the Commitment Fee. We paid the initial Commitment Fee of $612,500 through the issuance of 140,080 Depositary Shares to the Purchaser. We may direct C/M to purchase a specified number of ADSs not to exceed $2.5 million on any given day, at a price based on a formula, typically 95% of the closing price on the prior day. As of June 30, 2025, the Company had raised gross proceeds of $8.56 million from the ELOC. Warrant Inducement In May 2025 we entered into letter agreements with certain holders of outstanding Series E, Series H, Series J and Series K warrants to reduce the exercise price of such warrants to $0.31 per share. The holders exercised an aggregate of 200,433 warrants representing the same number of ADSs. We received gross proceeds of approximately $62,000, before offering expenses. The Company did not issue new warrants to replace the exercised warrants and did not engage a placement agent to facilitate the transaction. 1H25 FINANCIAL REVIEW The unaudited results for the six months ended June 30, 2025 are discussed below: Key performance indicators (KPIs): Biodexa’s KPIs focus on the key areas of operating results, R&D spend and cash management. These measures provide information on the core R&D operations. Additional financial and non-financial KPIs may be adopted in due course. Revenues Revenue for both periods was £Nil. The last of the Company’s R&D collaborations concluded in September 2023. Research and Development R&D costs for 1H25 and 1H24, analysed by development project indication were as follows: R&D costs in 1H25 reduced by £0.52 million, or 24%, to £1.67 million compared with £2.19 million in 1H24. The percentage of R&D costs as a percentage of total operating costs decreased to 41% in the period from 52%. The reduction in R&D costs in 1H25 reflects a reduction in spend of £0.56 million on the MAGIC-G1 study in rGBM and preclinical studies offset by an increase in expenditure (net of CPRIT grant income) on MTX230 (eRapa). The percentage of MTX230 (eRapa) costs that were able to be offset against grant funding during the period was 82% and we anticipate that over the life of the grant this will be 67%. Administrative Costs Administrative costs in 1H25 increased by £0.34 million, or 17%, to £2.38 million from £2.03 million in 1H24. The increase in administrative costs in 1H25 is driven by a foreign exchange charge of £0.40 million in the period compared to a £0.06 million gain in 2024. This was offset by a reduction in transaction related costs of £0.13 million. Transaction costs in the period included a £0.37 million non- cash upfront commitment fee for the ELOC. Finance Income and Expense Finance income in 1H25 and 1H24 included gains in respect of an equity settled derivative financial liability of £0.15 million (1H24: £0.75 million). The gains arose as a result of the fall in the Biodexa share price. In addition, the Company earned interest on cash deposits. Finance expense in the period related to lease liabilities, discounted interest on deferred consideration and interest on the promissory note issued in December 2024. Cash Flows Cash outflows from operating activities in 1H25 were £3.30 million compared to £4.81 million in 1H24, driven by a net loss of £3.81 million (1H24: £3.31 million) and after negative working capital of £0.04 million (1H24: negative £0.87 million) and other positive non-cash items totalling £0.24 million (1H24: negative £0.63 million). Net cash used in investing activities in 1H25 of £0.34 million (1H24: outflow £0.75 million) resulted from the payment of deferred consideration on the eRapa licence of £0.37 million (1H24: £0.85 million) offset by £0.04 million of interest received (1H24: £0.10 million). Net cash generated from financing activities in 1H25 was £6.01 million (1H24: inflow £4.65 million), which was driven by £6.20 million proceeds from share issuances under the ELOC, £0.05 million net proceeds from a warrant inducement, offset by loan repayments (including interest) of £0.15 million and payments on lease liabilities of £0.10 million. Overall, cash increased by £2.37 million in 1H25 compared to a decrease of £0.92 million in 1H24. This resulted in a cash balance at June 30, 2025 of £4.04 million compared with £5.05 million at June 30, 2024 and £1.67 million at December 31, 2024. Going concern Biodexa has experienced net losses and significant cash outflows from cash used in operating activities over the past years as it develops its portfolio. For the six months to June 30, 2025, the Group incurred a consolidated loss from operations of £3.81 million (1H24: £3.31 million) and negative cash flows from operating activities of £3.30 million (1H24: £4.81 million). As of June 30, 2025, the Group had accumulated deficit of £154.13 million. The Group’s future viability is dependent on its ability to raise cash from financing activities to finance its development plans until commercialisation, generate cash from operating activities and to successfully obtain regulatory approval to allow marketing of its development products. The Group’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. The Directors believe there are adequate options and time available to secure additional financing for the Group and after considering the uncertainties, the Directors consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements. The Group’s consolidated financial statements have therefore been presented on a going concern basis, which contemplates the realisation of assets and the satisfaction of liabilities in the normal course of business. As at June 30, 2025, the Group had cash and cash equivalents of £4.03 million. The Directors have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of this interim financial information. These forecasts show that further financing will be required before the second quarter of 2026 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. Provided certain conditions are met, including the price of the Company’s ADSs quoted on NASDAQ being above $1.00, the Company may direct C/M to purchase ADSs and receive proceeds in accordance with a formula price for up to 36 months from January 2025. There is no guarantee that the Company will be able to use the ELOC to the extent necessary to finance the Company’s operations. In the Directors’ opinion, the environment for financing of small and micro-cap biotech companies remains challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by Biodexa are likely to be dilutive. The Directors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Group. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any of alternative courses of action to finance the Group would be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon the Group’s ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Group which are actionable before its cash resources run out then the Group will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities. Stephen Stamp Chief Executive Officer and Chief Financial Officer Consolidated Statements of Comprehensive Income For the six month period ended June 30 The accompanying notes form part of these financial statements Consolidated Statements of Financial Position The accompanying notes form part of these financial statements Consolidated Statements of Cash Flows For the six month period ended June 30 Consolidated Statements of Cash Flows (continued) For the six month period ended June 30 The accompanying notes form part of these financial statements Consolidated Statements of Changes in Equity (unaudited) The accompanying notes form part of these financial statements Notes Forming Part of The Consolidated Unaudited Interim Financial Information For the six month period ended June 30, 2025 1. Basis of preparation The unaudited interim consolidated financial information for the six months ended June 30, 2025 has been prepared following the recognition and measurement principles of the International Financial Reporting Standards, International Accounting Standards and Interpretations (collectively IFRS) issued by the International Accounting Standards Board (IASB), and as adopted by the UK and in accordance with International Accounting Standard 34 Interim Financial Reporting (‘IAS 34’). The interim consolidated financial information does not include all the information and disclosures required in the annual financial information and should be read in conjunction with the audited financial statements for the year ended December 31, 2024. The accounting policies adopted are consistent with those of the previous financial year and corresponding interim reporting periods. Book values approximate to fair value at June 30, 2025, June 30, 2024 and 31 December 31, 2024. The condensed interim financial information contained in this interim statement does not constitute statutory financial statements as defined by section 434(3) of the Companies Act 2006. The condensed interim financial information has not been audited. The comparative financial information for the six months ended June 30, 2024 and the year ended December 31, 2024 in this interim financial information does not constitute statutory financial statements for that period or year. The statutory financial statements for December 31, 2024 have been delivered to the UK Registrar of Companies. The auditor’s report on those accounts was unqualified and did not contain a statement under section 498(2) or 498(3) of the Companies Act 2006. The auditor’s report did draw attention to a material uncertainty related to going concern and the requirement, as of the date of the report, for additional funding to be raised by the Company by the fourth quarter of 2025. Biodexa Pharmaceutical’s annual reports may be downloaded from the Company’s website at https://biodexapharma.com/investors/financial-reports-and-presentations/#financial-reports or a copy may be obtained from 1 Caspian Point, Caspian Way, Cardiff CF10 4DQ. Going Concern – material uncertainty Biodexa has experienced net losses and significant cash outflows from cash used in operating activities over the past years as it develops its portfolio. For the six months to June 30, 2025, the Group incurred a consolidated loss from operations of £3.81million (1H24: loss £3.31 million) and negative cash flows from operating activities of £3.30 million (1H24 £4.81 million). As of June 30, 2025, the Group had accumulated deficit of £154.13 million. The Group’s future viability is dependent on its ability to raise cash from financing activities to finance its development plans until commercialisation, generate cash from operating activities and to successfully obtain regulatory approval to allow marketing of its development products. The Group’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. The Directors believe there are adequate options and time available to secure additional financing for the Group and after considering the uncertainties, the Directors consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements. The Group's consolidated financial statements have been presented on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As at June 30, 2025, the Group had cash and cash equivalents of £4.04 million. The Directors have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of this interim financial information. These forecasts show that further financing will be required before the second quarter of 2026 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. Provided certain conditions are met, including the price of the Company’s ADSs quoted on NASDAQ being above $1.00, the Company may direct C/M to purchase ADSs and receive proceeds in accordance with a formula price for up to 36 months from January 2025. There is no guarantee that the Company will be able to use the ELOC to the extent necessary to finance the Company’s operations. In the Directors’ opinion, the environment for financing of small and micro-cap biotech companies remains challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by Biodexa are likely to be dilutive. The Directors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Group. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any of alternative courses of action to finance the Company would be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon the Group’s ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Group which are actionable before its cash resources run out then the Group will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities. 2. Accounting for eRapa and CPRIT grant The License and Collaboration Agreement (“LCA”) entered into with Emtora in April 2024 meets the definition of a Joint Arrangement under IFRS 11, specifically related to the FAP program. A jointly controlled escrow account was established on completion of the LCA. All FAP program transactions are processed through the escrow account, including the Company’s deposits of matching funds, as set out in the agreement, the receipt of grant funding from CPRIT and the payment of eligible R&D expenses. Although the CPRIT grant and R&D supplier contracts are with Emtora, the joint arrangement nature of the LCA results in Emtora being deemed to be acting as the Company’s agent. Accordingly, the Company recognises 100% of the grant and 100% of the R&D expenditure. The CPRIT grant recognised is on a 1 for 2 match. In accordance with the Company’s accounting policy, the grant, as it is the re-imbursement of directly related costs, is credited to R&D costs in the same period in The Statements of Comprehensive Income. The escrow account is recognised within prepayments, CPRIT grant received in advance is recognised within deferred revenue and any grant not yet received is recognised in accrued income. In 1H25 the company recognised R&D costs of £0.5 million (1H24: £0.2 million) on the FAP project, made up of expenditure of £2.6 million (1H24: £0.5 million) netted against CPRIT grant of £2.1 million (1H24: £0.3 million). The balances in relation to the FAP project as at June 30 were as follows: * prepayment reflects only the escrow account balance 3. Finance income and expense The gain on the equity settled derivative financial liability in 1H25 and 1H24 arose as a result of the fall in the Biodexa share price. 4. Loss per share Basic loss per share amounts are calculated by dividing the net loss for the period from continuing operations, attributable to ordinary equity holders of the parent company, by the weighted average number of ordinary shares outstanding during the period. As the Group made a loss for the period the diluted loss per share is equal to the basic loss per share. At a General Meeting on 11 June 2025, shareholders approved the subdivision and redesignation of the Company’s Issued Ordinary Shares of £0.00005 each into to one Ordinary Share of £0.000001 each and 49 ‘D’ Deferred Shares of £0.000001 each. The ‘D’ Deferred Shares have limited rights and are effectively valueless. The share sub-division and redesignation did not impact the calculation of the denominator as the number of Issued Ordinary Shares did not change. The Company has considered the guidance set out in IAS 33 in calculating the denominator in connection with the issuance of Pre-Funded and Abeyance Shares. Management have recognised the warrants from the date of grant rather than the date of issue of the corresponding Ordinary Shares when calculating the denominator. The Group has made a loss in the current and previous periods presented, and therefore the options and warrants are anti-dilutive. As a result, diluted earnings per share is presented on the same basis as basic earnings per share. 5. Share capital and reserves Authorised, allotted and fully paid – classified as equity As at June 30, 2025 unaudited Number As at June 30, 2025 unaudited £ As at December 31, 2024 Number As at December 31, 2024 £ Ordinary shares of £0.000001 each 61,952,308,922 61,952 6,685,918,922 334,296 ‘A’ Deferred shares of £1 each 1,000,001 1,000,001 1,000,001 1,000,001 ‘B’ Deferred shares of £0.001 each 4,063,321,418 4,063,321 4,063,321,418 4,063,321 126,547,389,518 6,327,370 126,547,389,518 6,327,370 ‘D’ Deferred shares of £0.000001 each 2,482,747,137,178 2,482,747 - - Total 13,935,391 11,724,988 Ordinary and deferred shares were recorded as equity. At a General Meeting on 11 June 2025, shareholders approved the subdivision and redesignation of the Company’s Issued Ordinary Shares of £0.00005 each into to one Ordinary Share of £0.000001 each and 49 ‘D’ Deferred Shares of £0.000001 each. The ‘D’ Deferred Shares have limited rights and are effectively valueless. As at June 30, 2025 and December 31, 2024 the Company had 17,415 pre-funded warrants outstanding over ADS’s. These are recognised in the warrant reserve until exercise. In accordance with the Articles of Association for the Company adopted on 11 June 2025, the share capital of the Company consists of an unlimited number of ordinary shares of nominal value £0.000001 each. Ordinary and deferred shares were recorded as equity. 6. Related party transaction The Directors consider there to be no related party transactions during the periods reported other than Directors Remuneration. 7. Contingent liabilities The Company is in a dispute with a former advisor over fees. In the event the Company is unsuccessful in its dispute the amount due to the vendor is approximately $1.16 million, of which $0.82 million would be payable in cash and the remainder amount in warrants exercisable for our ADSs. The Directors note that in the event of an unfavourable resolution the Company would not be able to recoup the loss from another party. 8. Events after the reporting date On July 15, 2025, the Company announced a ratio change on its ADSs from one (1) ADS representing ten thousand (10,000) ordinary shares, to the new ratio of one (1) ADS representing one hundred thousand (100,000) ordinary shares (the "Ratio Change"). The effective date of the Ratio Change was July 31, 2025.
Investor releaseQuarter not tagged2025-06-27Results of Annual General Meeting
GlobeNewswire
Results of Annual General Meeting
June 27, 2023 Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) Results of Annual 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 that at its Annual General Meeting held yesterday, all resolutions put to the Company’s shareholders were duly passed. The full text of, inter alia, the resolutions proposed and passed at the Annual General Meeting can be found in the Notice of the Annual General Meeting on the Company's website at https://biodexapharma.com/investors/corporate-governance//#agms. About Biodexa Pharmaceuticals PLC Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non Muscle Invasive Bladder Cancer: tolimidone, under development as a for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-d…Read full documentShow less
June 27, 2023 Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) Results of Annual 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 that at its Annual General Meeting held yesterday, all resolutions put to the Company’s shareholders were duly passed. The full text of, inter alia, the resolutions proposed and passed at the Annual General Meeting can be found in the Notice of the Annual General Meeting on the Company's website at https://biodexapharma.com/investors/corporate-governance//#agms. About Biodexa Pharmaceuticals PLC Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non Muscle Invasive Bladder Cancer: tolimidone, under development as a for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com. Forward-Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.
Investor releaseQuarter not tagged2025-04-11Preliminary Results for the Year Ended 31 December 2024
GlobeNewswire
Preliminary Results for the Year Ended 31 December 2024
April 11, 2025 Biodexa Pharmaceuticals PLC(“Biodexa” or the “Company” or, together with its subsidiaries, the “Group”) Preliminary Results for the Year Ended 31 December 2024 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, announces its audited preliminary results for the year ended 31 December 2024. For more information, please contact: Biodexa Pharmaceuticals PLC Stephen Stamp, CEO, CFO Tel: +44 (0)29 2048 0180www.biodexapharma.com About Biodexa Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer; tolimidone, under development for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. eRapa is a proprietary oral formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Tolimidone is an orally delivered, potent and selective activator of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more informa…Read full documentShow less
April 11, 2025 Biodexa Pharmaceuticals PLC(“Biodexa” or the “Company” or, together with its subsidiaries, the “Group”) Preliminary Results for the Year Ended 31 December 2024 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, announces its audited preliminary results for the year ended 31 December 2024. For more information, please contact: Biodexa Pharmaceuticals PLC Stephen Stamp, CEO, CFO Tel: +44 (0)29 2048 0180www.biodexapharma.com About Biodexa Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer; tolimidone, under development for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications. eRapa is a proprietary oral formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Tolimidone is an orally delivered, potent and selective activator of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent. MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com. Forward-Looking Statements Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein. Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising. INTRODUCTION Headquartered in Cardiff, UK, with its American Depositary Shares (“ADSs”) quoted on the NASDAQ exchange in the US, Biodexa is a clinical-stage biotechnology company developing a pipeline of innovative products for the treatment of 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. STRATEGY The Company’s transition from a drug delivery company to a therapeutics company is now complete with a pipeline of assets, all of which are at clinical stage and, we believe, offer significant potential to improve outcomes for patients. Following the successful re-positioning of the Company in 2024, our priorities for 2025 reflect our new strategy as follows: BUSINESS MODEL Having successfully transitioned to a therapeutics company and broadened our internal pipeline, our business model is to add value to our development programmes by advancing them through the clinic before seeking partners to complete late-stage studies and commercialise the products. Development Our intention is to build a balanced portfolio of clinical-stage development assets, ideally with a focus on rare/orphan indications. eRapa was in-licensed in April 2024 as Phase 3 ready in FAP with an ongoing Phase 2 study in NMIBC. Tolimidone, which was in-licensed in December 2023, is a Phase 2 ready asset being developed initially for T1D. MTX110 is currently in Phase I development for three rare/orphan brain cancers. Manufacturing We do not intend to establish our own manufacturing capabilities. For clinical trial material we utilise GMP-certified contract manufacturers. Commercialisation Once proof-of-concept has been established, we intend to out-license our products to a partner who would complete the clinical development and subsequently market and sell them in the licensed territory. In addition to reimbursement of development costs, the partner would be expected to make milestone payments based on sales targets and royalty payments. Our development pipeline now includes five projects, all which are at clinical stage, as follows: CLINICAL-STAGE ASSETS eRapa eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis1. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune® (Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. Familial Adenomatous Polyposis (FAP)FAP is characterized as a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation in the US and we are in the process of seeking such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. ERapa received FDA Fast Track designation in February 2025. The results of the Phase 2 study were presented at two leading scientific conferences in the second quarter of 2024. Following a positive end of Phase 2 meeting with the FDA, we have requested a Type C meeting with the FDA to finalize the protocol for a Phase 3 multi-centre, double-blind, placebo-controlled study in FAP. The Phase 3 study, which is expected to be registrational, plans to recruit approximately 168 patients across thirty or more sites, with a primary endpoint being time to a defined progression free survival event. The study is expected to recruit over 18 months and is supported by a non-dilutive grant of $17.0 million from CPRIT. Non-muscle Invasive Bladder Cancer (NMIBC)NMIBC refers to tumors found in the tissue that lines the inner surface of the bladder. The most common treatment is transurethral resection of the bladder tumour followed by intravesical Bacillus Calmette-Guerin (“BCG”) with chemotherapy depending upon assessment of risk of recurrence. NMIBC is the fourth most common cancer in men with an incidence of 10.1 per 100,000 and 2.5 per 100,000 in women. Our ongoing multi-centre, double-blind, placebo-controlled Phase 2 study in NMIBC is expected to enrol up to 166 patients with primary endpoints of safety/tolerability and relapse free survival after 12 months of treatment. The Phase 2 study, which is supported by a $3.0 million non-dilutive grant from the National Cancer Institute, part of the National Institutes of Health, is expected to read out in the first half of 2025. Tolimidone Tolimidone was originally discovered by Pfizer Inc. (“Pfizer”) and was developed through Phase 2 for the treatment of gastric ulcers. Pfizer undertook a broad pre-clinical programme to characterise the pharmacology, pharmacokinetics, metabolism and toxicology of tolimidone. Pfizer discontinued development of the drug due to lack of efficacy for that indication in Phase 2. Tolimidone is a selective activator of the enzyme Lyn kinase which increases phosphorylation of insulin substrate -1, thereby amplifying the signalling cascade initiated by the binding of insulin to its receptor. Type 1 Diabetes (T1D)We intend to develop tolimidone for the treatment of T1D. As a Lyn kinase activator, tolimidone has been shown in preclinical experiments to have a role in beta cell survival and proliferation. If replicated in clinical studies, tolimidone could have the potential to be disease modifying and change the treatment paradigm for T1D. T1D affects approximately 8.4 million people worldwide and there are approximately 500,000 new diagnoses per annum.As a first step in the planned continued clinical development of tolimidone, we intend to initiate a Phase 2a dose confirmation study to establish the optimum dose of tolimidone in patients with T1D. The Phase 2a study will be open-label in approximately 15 patients with T1D treated over a period of three months with endpoints of change in C-peptide levels, HbA1c and number of hyperglycaemic events. MTX110 Using our MidaSolve technology in combination with panobinostat, an otherwise insoluble drug, MTX110 is designed for direct-to-tumour administration via a catheter system (Convection Enhanced Delivery, or “CED”) thereby bypassing the blood-brain barrier and allowing for high drug concentrations and broader drug distribution in and around the tumour while simultaneously minimising systemic toxicity and other side effects. Panobinostat is currently marketed under the brand Farydak® which is used orally in combination therapy for the treatment of multiple myeloma. We are currently researching the utility of MTX110 to proof-of-concept stage in three indications: Glioblastoma Multiforme (GBM)GBM is the most common and aggressive form of brain cancer in adults, usually occurring in the white matter of the cerebrum. Treatments include radiation, surgical resection and chemotherapy although, in almost all cases, tumours recur. There are approximately 2-3/100,000(1) population diagnoses of GBM per annum. Survival with standard of care treatment ranges from approximately 13 months in unmethylated MGMT patients to approximately 30 months in highly methylated MGMT patients(2). Once it has recurred, median survival is 6.5 months(3). During 2023 we completed recruitment of patients in the first cohort of a Phase I study to assess the utility of MTX110 in recurrent GBM. The Phase I study is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (“CED”) via implanted refillable pump and catheter. The study aims to recruit two cohorts, each with a minimum of four patients; the first cohort received MTX110 only and the second cohort will also receive MTX110 but, at the option of the treating clinician, the catheter may be re-positioned once recurrence occurs. Diffuse Midline Glioma (DMG)DMG tumours are located in the pons (middle) of the brain stem and are diffusely infiltrating. Occurring mostly in children, approximately 1,000 patients(4) worldwide are diagnosed with DIPG per annum and median survival is approximately 10 months(5). There is no effective treatment since surgical resection is not possible. The standard of care is radiotherapy, which transiently improves symptoms and survival. Chemotherapy does not improve survival and one likely reason is that many anti-cancer drugs cannot cross the blood-brain barrier to access the tumour. In October 2020, we reported the first-in-human study by the University of California, San Francisco (“UCSF”) of MTX110 in DMG using a CED system. The Phase I study established a recommended dose range for Phase II, a good safety and tolerability profile but also encouraging median survival data of 26 months in the seven patients treated. An additional Phase I Investigator Initiated Trial by Columbia University reported topline data in February 2024. Thereafter, we intend to explore the possibility of seeking an IND for a Phase II study of MTX110 in DMG. MedulloblastomaMedulloblastomas are malignant embryonal tumours that start in the cerebellum. They are invasive and, unlike most brain tumours, spread through the cerebrospinal fluid (“CSF”) and frequently metastasise to different locations in the brain and spinal cord. Treatments include resection, radiation and chemotherapy. Approximately 350 patients(6) are diagnosed with medulloblastoma per annum and 3,800 people are living with the disease in the US. The cumulative survival rate is approximately 60%, 52%, and 47% at 5 years, 10 years and 20 years, respectively(7); however, recurrence is nearly always fatal with no established standard of care. The University of Texas is undertaking a Phase I exploratory study in recurrent medulloblastoma patients using direct administration of MTX110 into the fourth ventricle, enabling it to circulate throughout the central spinal fluid. (1) American Association of Neurosurgeons. (2) Radke et al (2019). Predictive MGMT status in a homogeneous cohort of IDH wildtype glioblastoma patients. Acta Neuropathologica Communications 7:89 Online: https://doi.org/10.1186/s40478-019-0745-z. (3) J Neurooncol. 2017; 135(1): 183–192. (4) Louis DN, Ellison DW, et al. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol 2016; 131:803–820. (5) Jansen et al, 2015. Neuro-Oncology 17(1):160-166. (6) Aboian et al (2018). Neuro-Oncology Practice, Volume 5, Issue 4, December 2018. (7) Smoll NR (March 2012). ‘Relative survival of childhood and adult medulloblastomas and primitive neuroectodermal tumors (PNETs)’. Cancer. 118 (5): 1313–22. (8) https://my.clevelandclinic.org/health/diseases/22737-leptomeningeal-disease. CHIEF EXECUTIVE’S REVIEW Introduction During 2024, we took significant steps to diversify and advance our development pipeline by adding late-phase eRapa to tolimidone and MTX110 R&D programmes. The addition of eRapa is expected to enhance the Company's news flow and provide catalysts for financing as the two indications advance through the clinic. R&D update eRapa In April 2024 we licensed eRapa, a proprietary formulation of rapamycin, from Rapamycin Holdings, Inc. d/b/a Emtora Biosciences, Inc. (“Emtora”). Rapamycin is an mTOR inhibitor. As a central regulator of cell metabolism, growth, proliferation and survival, the mTOR pathway is activated during various cellular processes including tumour formation and angiogenesis. Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. On May 21, 2024, we announced six month results of the Phase 2 clinical trial of eRapa in FAP (NCT04230499) which were presented at the 2024 Digestive Disease Week annual meeting in Washington D.C. In the duodenum, 14/18 (78%) patients were non-progressors with 11/18 (61%) of these patients with PR. In the colorectum, 25/29 (86%) patients were non progressors including all with an intact colon; of these 15/29 (67%) patients demonstrated PR including 4 with an intact colon (see Figure 1 below). Only two drug-related Grade 3 Serious Adverse Events occurred during the trial (with no Grade 4 or 5 reported), and 97% of patients remained on treatment at six months. In summary, after six months’ treatment, eRapa appeared safe and well-tolerated with a significant 24% reduction in the total polyp burden at six months compared with baseline (p=0.04) and an overall 83% non-progression rate. On June 24, 2024, we announced 12 month results of the Phase 2 clinical trial which were presented at the 2024 InSIGHT bi-annual meeting in Barcelona. Overall, 21 of 28 (75%) patients were deemed to be non-progressors at 12 months with a median reduction in polyp burden of 17%. Over the course of 12 months, there were four related Grade 3 or higher and one related Serious Adverse Event reported during the trial and 95% compliance rate at 12 months. One patient was removed from the trial due to non-compliance. In summary, after 12 months’ treatment, eRapa appeared safe and well-tolerated with a median 17% reduction in the total polyp burden at 12 months compared with baseline and an overall 75% non-progression rate. The 89% non-progression rate and 29% median reduction in polyp burden observed in Cohort 2 will be the dosage regimen for Phase 3. The open-label Phase 2 study was conducted in seven U.S. centres of excellence in 30 adult patients with median age of 43 years with intact colon (n=6) or post-colectomy and ileo-rectal anastomosis and at least 10 adenomas in the rectal remanent (n=24). Patients were sequentially enrolled into three dosing cohorts of 10 patients each for a 12-month treatment period: 0.5mg every other day (Cohort 1), 0.5mg daily every other week (Cohort 2), and 0.5mg daily (Cohort 3). Upper and lower endoscopic surveillance occurred at baseline and after six months. Primary endpoints were the safety and tolerability of eRapa and percentage change from baseline in polyp burden, as measured by the aggregate of all polyp diameters. In February 2025, we announced that the FDA had granted Fast Track designation to eRapa in FAP. An ongoing Phase 2 study of eRapa in NMIBC is scheduled to report results in mid-2025. Tolimidone In December 2023, we secured the global rights to develop and commercialise tolimidone. The Phase II ready product is supported by very substantial preclinical data, has been exposed to more than 700 patients and has demonstrated compelling preclinical data to support our chosen indication of T1D. In T1D, the body’s immune system attacks pancreatic beta cells such that they can no longer produce insulin which is required to regulate plasma glucose levels. The causes of T1D are not fully understood and there is currently no cure. Patients with T1D are dependent on daily administration of insulin (via injection or infusion). Tolimidone is a Lyn kinase activator and its potential utility in T1D was first demonstrated by several ground-breaking preclinical studies conducted at the University of Alberta, where Lyn kinase was identified as a key factor for beta cell survival and proliferation in vitro and in vivo models. Tolimidone was shown to both prevent beta cell degradation and to stimulate beta cell proliferation. The Phase 2a study will be open-label and include three doses with approximately 15 patients studied over three months with a follow up period. End points are expected to include C-peptide levels (a marker for insulin), HbA1c levels (a marker for plasma glucose) and a number of severe hyperglycaemic events. Thereafter, we expect to follow up by a double-blind, placebo-controlled Phase IIb study in approximately 40-45 patients with similar clinical endpoints. MTX110 In October 2023, we announced completion of recruitment of Cohort A of our ongoing open-label Phase I dose-escalation study, which is designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by CED via implanted refillable pump and catheter. Because no drug-related adverse events were observed within the first 30 days from the start of treatment, the minimum number of four patients were recruited into Cohort A. Patient #1 received weekly infusions of 60µM of MTX110 and Patients # 2, 3 and 4 each received 90µM, the expected optimum dose. The study site reported 12 months of survival from the start of the treatment in the 1st patient (OS=12 months). We initially began developing MTX110 for DMG, the ultra-rare, highly aggressive and inoperable form of childhood brain cancer. In February 2024 we announced the results of a Phase I study conducted by Columbia University Irving Medical Center. As this was the first ever study of repeated infusions to the pons via an implanted CED catheter, the primary objective of the study was safety and tolerability and, accordingly, the number of infusions was limited to two, each of 48 hours, 7 days apart. Nine patients were treated in the study (30 µM group, n=3; 60 µM group, n=4; 90 µM group (optimal dose), n=2). One patient in the 60 µM group suffered a severe adverse event assessed by the investigators as not related to the study drug but related to the infusion and tumour anatomy. Although the study was not powered to reliably demonstrate efficacy, median overall survival (“OS”) of patients in the study was 16.5 months. In October 2023, we announced completed recruitment of four patients into cohort A of its Phase 1 study of MTX110 (also known as MAGIC-G1 study) (NCT 05324501) in patients with rGBM. MAGIC-G1 is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. Patients received MTX110 via intermittent repeated CED infusions. The status of patients in Cohort A was as follows: Patients #1 and #2 had deceased with overall survival (OS) since start of treatment of 12 months and 13 months, respectively. Patients #3 and #4 remained in post-study follow-up. Patient #3 had progression free survival (PFS) of six months and OS at that time of 13 months since start of treatment. Patient #4 has not yet had confirmed progression and had PFS and OS of 12 months since start of treatment. We are also evaluating the utility of MTX110 in medulloblastoma in a pilot study at the University of Texas. Financings Warrant Inducement In May 2024, we entered into agreements with certain investors that were holders of 1,572,674 of our outstanding Series E Warrants exercisable for $2.20 per Depositary Share and an aggregate of 2,463,477 of our Series F Warrants exercisable for $2.20 per Depositary Share, or Series F Warrants. The holders agreed to exercise the Series E Warrants and Series F Warrants, as applicable, at a reduced exercise price of $1.50 per Depositary Share. Upon closing of the transaction we issued 3,104,566 Depositary Shares to the Holders, with the remaining 931,585 Depositary Shares remaining unissued but held in abeyance until we receive notice from the holders that the remaining shares may be issued in compliance with the beneficial ownership limitation. In consideration for the immediate exercise of the Series E Warrants and/or Series F Warrants for cash, we issued one replacement Series G Warrant for each Series E Warrant exercised, and one replacement Series H Warrant for each Series F Warrant exercised. The Series G and Series H Warrants were exercisable immediately and expire after five years and one year, respectively. We received gross proceeds of approximately $6.05 million from the warrant exercise, prior to deducting the warrant inducement agent fees and other expenses. Registered Direct Offering and Concurrent Private Placement In July 2024, we closed a Registered Direct Offering and Private Placement with certain institutional investors for the sale of (i) an aggregate of 5,050,808 Depositary Shares, and (ii) an aggregate of 278,975 pre-funded warrants exercisable for Depositary Shares at a price per Depositary Share of $0.94, and a price per Pre-Funded Warrant of $0.9399. The Pre-Funded Warrants were exercisable immediately. In addition, in a concurrent Private Placement, we issued and sold to the Investors (i) Series J Warrants exercisable for 5,329,783 Depositary Shares, and (ii) Series K Warrants, exercisable for 5,329,783 Depositary Shares. The Series J and Series K Warrants are exercisable immediately and expire after one year and five years respectively and are all exercisable at an exercise price of $25.00 per Depositary Share. We received aggregate gross proceeds of $5.0 million before deducting the placement agent’s fees and related offering expenses. Promissory Note In December 2024 we issued an unsecured promissory note to C/M Capital Master Fund LP in the principal amount of $600,000 at a 10% original issue discount. The Note is an unsecured obligation of the Company and bears interest at an annual rate of 5% and has a maturity date of one year. The Note includes a monthly repayment schedule, with the entire principal amount of the Note, plus interest, being repaid by December 2025. We received the $540,000 pursuant to the Note in December 2024. Outlook We expect two major clinical milestones in 2025; the initiation of our Phase 3 registrational study of eRapa in FAP and, the initiation of an IIT of tolimidone in T1D at the University of Alberta. As has been the case for the past three years, financing for small- and micro-cap biotech companies remains challenging. The $35 million Equity Line of Credit (“ELOC”) we put in place in February 2025 provides a welcome backstop source of capital as we seek non-dilutive sources of capital from out-licensing territorial rights to our development assets and/or additional grant funding. FINANCIAL REVIEW Introduction Biodexa Pharmaceuticals PLC was incorporated as a company on 12 September 2014 and is domiciled in England and Wales. Financial analysis Key performance indicators Revenue In the year ended 31 December 2024, Biodexa did not generate any gross revenue (2023: £0.38 million). Customer revenue in 2023 was derived entirely from the Group’s R&D collaboration agreements with Janssen which ceased in September 2023. Research and development expenditure Research and development costs were £5.44 million, an increase of £1.37 million, or 34% on 2023 (2023: £4.07 million). The percentage of R&D costs as a percentage of operating costs also increased to 59% from 48% in the prior year. The increase in the year reflects the Directors decisions to acquire licenses for clinical stage assets, tolimidone in December 2023 and eRapa in April 2024, resulting in clinical expenditure of £1.09 million and £1.91 million respectively, this is offset by reduced spend of £1.10 million on the MAGIC-G1 study in rGBM. As a result of the re-focus on clinical stage assets there was a reduction in pre-clinical expense of £0.31 million. Personnel costs also reduced by £0.25 million in the year. Administrative costs Administrative costs in the year reduced by £0.55 million to £3.79 million (2023: £4.34 million), a decrease of 13%. The decrease in administrative costs in the year is driven by a positive reversal in foreign exchange of £0.26 million, a reduction in professional fees of £0.55 million offset by an increase in share-based payments of £0.22 million. In 2024 the Company expensed £0.88 million on legal and professional fees in connection with the successful financing transactions in the year, the acquisition of the eRapa licence in April 2024 and aborted acquisitions, this compares to £1.31m spent in 2023 on similar transactions. Staff costs During the year, the average number of staff decreased to 13 (2023: 21), reflecting the cost reduction program undertaken in March 2023. Total staff cost increased 4% to £2.15 million (2023: £2.06 million), driven by the increase in share-based payment charge of £0.22 million. Taxation During 2024 and 2023 we recognised U.K research and development tax credits of £0.25 million and £0.41million in respect of R&D expenditure incurred. Capital expenditure Purchase of tangible fixed assets in 2024 was £0.01 million (2023: £0.03 million) and related to investment in laboratory equipment. In addition, in April 2024, the Company purchased an intangible asset being the global rights to develop and commercialise eRapa for total consideration of £2.71 million, this was satisfied £0.77 million in cash, £0.22 million by the issue of ordinary shares and deferred consideration of £1.72 million yet to be paid. Cash flow Net cash outflow from operating activities in 2024 was £12.26 million (2023: outflow £6.83 million) driven by a net loss of £5.73 million (2023: loss £7.08 million) and after negative movements in working capital of £3.74 million (2023: negative £0.05 million), taxes received of £0.13 million (2023: £0.84 million), and other net negative adjustments for non-cash items totalling £2.93 million (2023: negative £0.54 million). Investing activities outflow in 2024 of £0.60 million (2023: outflow of £0.27 million) included purchases of property, plant and equipment of £0.01 million (2023: £0.03 million), purchase of eRapa licence for total consideration of £2.71 million including cash of £0.77 million. These cash outflows are offset by interest income from bank deposits of £0.18 million (2023: £0.07 million). Financing activities inflow in 2024 of £8.56 million (2023: inflow of £10.23 million) was driven by receipts from share issues of £8.31 million (2023: £10.43 million) and receipt from issuance of promissory note £0.43 million (2023: £Nil). The other principal outflows related payments on lease liabilities of £0.19 million (2023: £0.19 million and interest paid of £Nil (2023: £0.01million). As a result of the foregoing, net cash outflow for the year was £4.30 million (2023: inflow of £3.14 million). Regained Compliance with NASDAQ In August 2024, we received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC notifying us that NASDAQ had determined to delist our securities from the NASDAQ Capital Market because our securities had a closing bid price below $1.00 for 30 consecutive business days, We requested a hearing, which automatically stayed any suspension or delisting action pending the hearing. The hearing took place on 8 October 2024 and on 7 November 2024, we were notified that the Hearings Panel had determined that we had regained compliance with the Minimum Bid Price Requirement. Change in ADS Ratio and Nominal Value of Ordinary Shares On 4 October 2024 the Company effected a change in the ratio of the Company’s Ordinary Shares from each ADS representing 400 Ordinary Shares to each ADS representing 10,000 Ordinary Shares. At a General Meeting on 22 November 2024, shareholders approved the subdivision and redesignation of the Company’s Issued Ordinary Shares of £0.001 each into to one Ordinary Share of £0.00005 each and 19 ‘C’ Deferred Shares of £0.00005 each. The ‘C’ Deferred Shares have limited rights and are effectively valueless. January 2025 Committed Equity Financing – Equity Line of Credit (“ELOC”) On 17 January, 2025, we entered into an ELOC with C/M Capital Master Fund LP (“C/M”) pursuant to which we have the right, but not the obligation, to sell to C/M, and C/M is obligated to purchase, up to $35.0 million of newly issued ADSs for a period of 36 months from Commencement Date. As consideration for the Seller Shareholder’s execution and delivery of the Purchase Agreement, we have agreed to pay to the Selling Shareholder a Commitment Fee of $875,000 in cash or in ADSs. At any time after the Commencement Date, we may direct C/M to purchase a specified number of ADSs, or a Fixed Purchase, not to exceed $200,000, at a purchase price equal to the lesser of 95% of (i) the daily volume weighted average price, or VWAP, of the Depositary Shares for the five trading days immediately preceding the applicable Purchase Date for such Fixed Purchase and (ii) the lowest sale price of an ADS Share on the trading day immediately preceding the Purchase Date. In addition, we may also direct C/M to purchase an additional number of ADSs in an amount up to the VWAP Purchase Maximum Amount (as defined in the Purchase Agreement), or a VWAP Purchase, at a purchase price equal to the lesser of 95% of (i) the closing price of an ADS on the trading day immediately preceding the applicable VWAP Purchase Date and (ii) the VWAP during the period on the applicable VWAP Purchase Date beginning at the opening of trading and ending at the VWAP Purchase Termination Time (as defined in the Purchase Agreement). Lastly, we may also direct C/M to purchase an Additional VWAP Purchase at a purchase price equal to the lesser of 95% of (i) the closing price of an ADS on the trading day immediately preceding the applicable Additional VWAP Purchase Date and (ii) the VWAP during the Additional VWAP Purchase Period (as defined in the Purchase Agreement) on the applicable Additional VWAP Purchase Date. Under the Purchase Agreement, the aggregate amount of Purchase Shares submitted in any single or combination of VWAP Purchase notices and/or Additional VWAP Purchase notices on a particular date require a payment from C/M to us not exceeding $2.5 million. C/M is not obligated to purchase any ADSs pursuant to the Purchase Agreement if, when aggregated with all other securities then beneficially owned by C/M would result in C/M beneficially owning Ordinary Shares (represented by Depositary Shares) in excess of 9.99% of the then-outstanding Ordinary Shares. The net proceeds under the Purchase Agreement to us will depend on the frequency and prices at which we sell Depositary Shares to the Selling Shareholder. We expect that any proceeds received by us from such sales to the Selling Shareholder will be used to fund our development programs, for working capital and other general corporate purposes. Going Concern – material uncertainty The Group and Company has experienced net losses and significant cash outflows from cash used in operating activities over the past years as it develops its portfolio. For the year ended 31 December 2024, the Group incurred a consolidated loss for the year of £5.73 million and negative cash flows from operations of £12.26 million. As of 31 December, 2024, the Group had an accumulated deficit of £150.42 million. The Group’s future viability is dependent on its ability to raise cash from financing activities to finance its development plans until milestones and/or royalties can be secured from partnering the Company’s assets. The Group’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. The Directors believe there are adequate options and time available to secure additional financing for the Company and after considering the uncertainties, the Directors consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements. The Group's consolidated financial statements have therefore been presented on a going concern basis, which contemplates the realisation of assets and the satisfaction of liabilities in the normal course of business. As at 31 December 2024, the Group had cash and cash equivalents of £1.67 million. The Directors have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of the consolidated financial statements. These forecasts show that further financing will be required before Q4 2025 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. Pursuant to its $35 million Equity Line of Credit, or ELOC, as described above, the Company may direct C/M to purchase ADSs (subject to certain limitations) and receive proceeds in accordance with a formula price for up to 36 months from the Commencement Date. There is no guarantee that the Company will be able to use the ELOC to the extent necessary to finance the Company’s operations. In the Directors’ opinion, the environment for financing of small and micro-cap biotech companies remains challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by Biodexa are likely to be dilutive. The Directors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Group. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any alternative courses of action to finance the Company would be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon the Group and Parent Company’s ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Company which are actionable before its cash resources run out then the Company will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities. Macro-economic environment The invasion by the Russian Federation military in Ukraine in early 2022 and the ongoing Israeli/Palestinian conflict in the Middle East has had a destabilising impact on the global economy. Although there has been no immediate impact on the Group, it is not possible to assess the medium- and long-term impact of these conflicts on the Group and the global economy generally. In addition, U.S. President Trump has increased, and has indicated his willingness to continue to increase, the use of tariffs by the U.S. to accomplish certain U.S. policy goals. Such tariffs and any countermeasures could increase the cost of raw materials and components necessary for our operations, disrupt our supply chain and create additional operational challenges. Further, it is possible that government policy changes and related uncertainty about policy changes could increase market volatility. Because of these dynamics, we cannot predict the impact of any future changes to the U.S.’s or other countries’ trading relationships or the impact of new laws or regulations adopted by the U.S. or other countries on our business. Such changes in tariffs and trade regulations could have a material adverse effect on our financial condition, results of operations and cash flows. Environmental matters, community, human rights issues and employees As at 31 December 2024 the Group had 11 employees, of whom 5 were routinely based at its offices in Cardiff, Accordingly the Company believes it has a relatively modest environmental impact. All materials imported into the Company’s laboratories are assessed for safety purposes and appropriate handling and storage safeguards imposed as necessary. Any small quantities of hazardous materials are removed by licensed waste management contractors. A number of policies and procedures governing expectations of ethical standards and the treatment of employees and other stakeholders are set out in the Company’s Employee Handbook. The Company has also established an anti-slavery policy pursuant to the Modern Slavery Act 2015. The Company strives to be an equal opportunity employer, irrespective of race or gender. At 31 December 2024, the number of male/female employees was 27%/73%, the number of male/female senior managers was 60%/40% and the number of male/female Directors was 80%/20%. Annual greenhouse gas emissions We measure our environmental performance by reporting our carbon footprint in terms of tonne CO2 equivalent. We report separately on our indirect emissions from consumption of electricity (Scope 2) and emissions consisting of employee travel in cars on Group business estimated on the basis of miles travelled (Scope 3). The Group have elected to monitor and report its energy efficiency using tonnes of CO2 per employee as an intensity ratio. Methodology In calculating the reported energy usage and equivalent greenhouse gas emissions the Group have referred to the HM Government Environment Reporting Guidelines and the GHG Reporting Protocol. A location-based allocation methodology was used to calculate electricity usage. The Group’s electricity costs for 2024 were approximately £25,000 (2023: £30,000). The kWh usage in the year was 81,933 (2023: 87,780). The Group has no immediate plans to improve energy efficiency. CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME For the year ended 31 December The notes form an integral part of these consolidated financial statements. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION At 31 December The notes form an integral part of these consolidated financial statements. CONSOLIDATED STATEMENTS OF CASH FLOWS For the year ended 31 December CONSOLIDATED STATEMENTS OF CASH FLOWS(CONTINUED) For the year ended 31 December The notes form an integral part of these consolidated financial statements. CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY For the year ended 31 December CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY(CONTINUED) NOTES FORMING PART OF THE FINANCIAL STATEMENTS For the year ended 31 December 2024 1. Basis of preparation The consolidated financial statements have been prepared in accordance with international accounting standards in conformity with the requirements of the Companies Act 2006, and they are prepared in accordance with international financial reporting standards. The consolidated financial statements have been prepared on a historical cost basis except that the following assets and liabilities are stated at their fair value: certain financial assets and financial liabilities measured at fair value, and liabilities for cash-settled share-based payments. The financial information contained in this final announcement does not constitute statutory financial statements as defined in Section 435 of the Companies Act 2006. The financial information has been extracted from the financial statements for the year ended 31 December 2024 which have been approved by the Board of Directors, and the comparative figures for the year ended 31 December 2023 and 31 December 2022 are based on the financial statements for that year. The financial statements for 2023 and 2022 have been delivered to the Registrar of Companies and the 2024 financial statements will be delivered after the Annual General Meeting. The auditor’s report for the Company’s 2024 Annual Report and Accounts was unqualified but did draw attention to the material uncertainty relating to going concern. The auditor’s report did not contain statements under s498(2) or (3) of the Companies Act 2006. Whilst the financial information included in this results announcement has been prepared in accordance with International Financial Reporting Standards (IFRSs) this announcement does not itself contain sufficient information to comply with IFRSs. The information in this results announcement was approved by the board on 10 April 2025. Going concern – material uncertainty The Group and Company has experienced net losses and significant cash outflows from cash used in operating activities over the past years as it develops its portfolio. For the year ended 31 December 2024, the Group incurred a consolidated loss for the year of £5.73 million and negative cash flows from operations of £12.26 million. As of 31 December 2024, the Group had an accumulated deficit of £150.42 million. The Group’s future viability is dependent on its ability to raise cash from financing activities to finance its development plans until milestones and/or royalties can be secured from partnering the Company’s assets. The Group’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. The Directors believe there are adequate options and time available to secure additional financing for the Company and after considering the uncertainties, the Directors consider it is appropriate to continue to adopt the going concern basis in preparing these financial statements. The Group's consolidated financial statements have therefore been presented on a going concern basis, which contemplates the realisation of assets and the satisfaction of liabilities in the normal course of business. As at 31 December 2024, the Group had cash and cash equivalents of £1.67 million. The Directors have prepared cash flow forecasts and considered the cash flow requirement for the Group for the next three years including the period 12 months from the date of approval of the consolidated financial statements. These forecasts show that further financing will be required before Q4 2025 assuming, inter alia, that certain development programs and other operating activities continue as currently planned. Pursuant to its $35 million Equity Line of Credit, or ELOC, as described in the Finance Review, the Company may direct C/M to purchase ADSs (subject to certain limitations) and receive proceeds in accordance with a formula price for up to 36 months from the Commencement Date. There is no guarantee that the Company will be able to use the ELOC to the extent necessary to finance the Company’s operations. In the Directors’ opinion, the environment for financing of small and micro-cap biotech companies remains challenging. While this may present acquisition and/or merger opportunities with other companies with limited or no access to financing, as noted above, any attendant financings by Biodexa are likely to be dilutive. The Directors continue to evaluate financing options, including those connected to acquisitions and/or mergers, potentially available to the Group. Any alternatives considered are contingent upon the agreement of counterparties and accordingly, there can be no assurance that any alternative courses of action to finance the Company would be successful. This requirement for additional financing in the short term represents a material uncertainty that may cast significant doubt upon the Group and Parent Company’s ability to continue as a going concern. Should it become evident in the future that there are no realistic financing options available to the Company which are actionable before its cash resources run out then the Company will no longer be a going concern. In such circumstances, we would no longer be able to prepare financial statements under paragraph 25 of IAS 1. Instead, the financial statements would be prepared on a liquidation basis and assets would be stated at net realizable value and all liabilities would be accelerated to current liabilities. 2. Accounting for eRapa and CPRIT grant On 25 April 2024 the Company entered into a License and Collaboration Agreement (LCA) with Rapamycin Holdings, Inc. (d/b/a Emtora Biosciences). The LCA entered into with Emtora meets the definition of a Joint Arrangement under IFRS 11, specifically related to the FAP program. A jointly controlled escrow account was established on completion of the LCA. All FAP program transactions are processed through the escrow account, including the Company’s deposits of matching funds, as set out in the agreement, the receipt of grant funding from CPRIT and the payment of eligible R&D expenses. Although the CPRIT grant and R&D supplier contracts are with Emtora, the joint arrangement nature of the LCA results in Emtora being deemed to be acting as the Company’s agent. Accordingly, the Company recognises 100% of the grant and 100% of the R&D expenditure. The CPRIT grant recognised is on a 1 for 2 match over the period of the grant, but can vary between periods. In accordance with the Company’s accounting policy, the grant, as it is the re-imbursement of directly related costs, is credited to R&D costs in the same period in the Statements of Comprehensive Income. The escrow account is recognised within prepayments, CPRIT grant received in advance is recognised within deferred revenue and any grant not yet received is recognised in accrued income. In 2024 the Company recognised R&D costs of £1.24 million on the FAP project, this was made up of expenditure of £2.45 million netted against CPRIT grant income of £1.21 million. The balances as at 31 December 2024 were as follows in relation to the FAP project: Prepayments £6.11 millionDeferred revenue £1.47 million 3. Finance income and expense The gain on the equity settled derivative financial liability in 2024, 2023 and 2022 arose as a result of the movement in share price. 4. Taxation The reasons for the difference between the actual tax credit for the year and the standard rate of corporation tax in the United Kingdom applied to losses for the year are as follows: The taxation credit arises on the enhanced research and development tax credits accrued for the respective periods. 5. Loss per share At a General Meeting on 22 November 2024, shareholders approved the subdivision and redesignation of the Company’s Issued Ordinary Shares of £0.001 each into to one Ordinary Share of £0.00005 each and 19 ‘C’ Deferred Shares of £0.00005 each. The ‘B’ Deferred Shares have limited rights and are effectively valueless. The share sub-division and redesignation did not impact the calculation of the denominator as the number of Issued Ordinary Shares did not change. During the year the Company issued warrants that were accounted through the Warrant Reserve as detailed in note 10. The Company has considered the guidance set out in IAS 33 in calculating the denominator in connection with the issuance of Pre-Funded warrants and abeyance shares as disclosed in note 10. Management have recognised the warrants from the date of grant rather than the date of issue of the corresponding Ordinary Shares when calculating the denominator. The Group has made a loss in the current and previous periods presented, and therefore the options and warrants are anti-dilutive. As a result, diluted loss per share is presented on the same basis as basic loss per share. 6. Intangible Assets The individual intangible asset which is material to the financial statements is as follows: *asset is not yet in use and has not started amortising On 25 April 2024 the Company entered into a LCA with Emtora, relating to the license of eRapa. In consideration for the License, the Company made an upfront payment of 15,1261 ADSs (equal to five percent of our then outstanding Ordinary Shares, calculated on a fully-diluted basis). In addition, a promissory note previously issued by Emtora in favour of the Company in the amount of $0.25 million was forgiven and certain historical liabilities relating to their on-going FAP and NMIBC programs were settled. The Company is also obligated to make quarterly payments to Emtora of $0.25 million less 75% of any research sales by Emtora until the handover trigger event occurs. The obligation meets the definition of a financial liability in accordance with IAS32 and is measured at fair value in accordance with IFRS9. Management have estimated the expected liability to be $3.1 million and the present value as $2.5 million. In addition, the Company is also responsible for up to $31.5 million in sales milestones within the first six months of commercial sale of a first-approved indication of eRapa in certain markets, with decreasing milestones for subsequent approvals for additional indications. There is also a one-time $10.0 million milestone payable upon cumulative net sales of $1.0 billion. Further, the Company is also obligated to pay Emtora single digit tiered royalties on net sales of eRapa, in addition to honouring Emtora’s legacy royalty obligations and paying Emtora fees related to income derived from sublicensing and partnering of eRapa. The LCA also provides the Company with the exclusive option to acquire all of the capital stock of Emtora on commercially reasonable terms in the 90 days after acceptance of the filing of an NDA by the U.S. Food and Drug Administration (the “FDA”). If the Company does not exercise the option, it would be required to make additional quarterly payments until the first commercial sale of the product. 1 Number of ADSs have been adjusted to reflect the ADS ratio change on 4 October 2024 7. Deferred Consideration The Company is obligated to make quarterly payments to Emtora of $0.25 million less 75% of any research sales by Emtora until the handover trigger event occurs. The obligation meets the definition of a financial liability in accordance with IAS32 and is measured at fair value in accordance with IFRS9. Management have estimated the expected liability to be $3.1 million and the present value as $2.5 million. This financial liability is measured on Level 3, the fair value is derived using a discounted cash flow approach. The discount rate applied to the obligation was 11.64% (2023: n/a). A 1% increase or decrease in the discount rate would decrease or increase the liability by approximately £0.03 million (2023: n/a) and £0.03 million (2023: n/a), respectively. An increase in the liability would result in a loss in the revaluation of financial instruments, while a decrease would result in a gain. There were no transfers between Level 1 and 2 in the period. 8. Borrowings Book values approximate to fair value at 31 December 2024, 2023 and 2022. Promissory note In December 2024 the Company issued a Promissory Note to C/M Capital Master Fund, LP in the aggregate principal amount of $600,000 at a 10% original issue discount. The Note is an unsecured obligation of the Company and bears interest at an annual rate of 5%, which may be increased under certain circumstances, and has a maturity date of one year from the Issuance Date. The Note includes a monthly repayment schedule, with the entire principal amount of the Note, plus accrued and unpaid interest, due and payable by the Company on the date that is twelve months from the Issuance Date. The Note may be prepaid prior to the Maturity Date without penalty. Additionally, prior to the Maturity Date and while the Note remains outstanding, upon the occurrence of each and every bona fide transaction or series of transactions conducted by the Company wherein the principal purpose of the Company is to raise capital, pursuant to which the Company issues and sells securities for an amount of gross proceeds equal to or greater than $500,000, the Company shall be obligated to utilize 25% of the gross proceeds from such Financing Event to prepay the Note, which repayment shall be due concurrently or immediately following the closing of such Financing Event. The Company received $540,000 pursuant to the Promissory Note on 24 December 2024. 9. Derivative financial liability – current Equity settled derivative financial liability is a liability that is not to be settled for cash. The Company issues warrants in the ADSs of the Company as part of registered direct offerings and private placements in the US. The number of ADSs to be issued when exercised is fixed, however the exercise price is denominated in US Dollars being different to the functional currency of the Company. Therefore, the warrants are classified as equity settled derivative financial liabilities recognised at fair value through the profit and loss account (‘FVTPL’). The financial liability is valued using the Black-Scholes model in 2024 and 2023, in previous periods the Monte Carlo model was used. The change in methodology is as result of the Company de-listing from AIM in 2023 and no longer needing to consider foreign exchange movements in the fair value calculation. Financial liabilities at FVTPL are stated at fair value, with any gains or losses arising on re-measurement recognised in profit or loss. The net gain or loss recognised in profit or loss incorporates any interest paid on the financial liability and is included in the ‘finance income’ or ‘finance expense’ lines item in the income statement. A key input in the valuation of the instrument is the Company share price. Details of the warrants are as follows: July 2024 warrants In July 2024 the Company issued 213,188 Series J ADS Warrants and 213,188 Series K warrants as part of the Registered Direct Offering and Concurrent Private Placement in the US. May 2024 warrants In May 2024 the Company issued 94,358 Series G ADS Warrants and 147,805 Series H warrants as part of the Warrant Inducement in the US. December 2023 warrants In December 2023 the Company issued 119,998 Series E ADS Warrants and 119,996 Series F ADS Warrants as part of the Registered Offering in the US. The Series F warrants expired on 23 December 2024. May 2023 warrants In June 2023 the Company issued 11,059 Series D ADS Warrants as part of a registered direct offering and private placement in the US after securing shareholder approval. May 2020 warrants In May 2020 the Company issued 30 ADS warrants as part of a registered direct offering in the US. October 2019 warrants In October 2019 the Company issued 15 ADS warrants as part of a registered direct offering in the US. Warrant re-price On 22 July 2024 the Company agreed to reduce the exercise price of the Company’s existing Series E warrants, Series G warrants and Series H warrants held by those investors who participated in the Registered Direct Offering and Concurrent Private Placement to $25.00 per ADS. *Number and original price of warrants have been adjusted to reflect the share consolidation and ratio change of ADS’s to ordinary shares that occurred on 24 March 2023 and the ratio change of ADS’s to ordinary shares on 26 September 2022, 5 July 2023 and 4 October 2024. DARA warrants and share options The Group also assumed fully vested warrants and share options on the acquisition of DARA Biosciences, Inc. (which took place in 2015). The number of ordinary shares to be issued when exercised is fixed, however the exercise prices are denominated in US Dollars. The warrants are classified equity settled derivative financial liabilities and accounted for in the same way as those detailed above. The financial liability is valued using the Black-Scholes option pricing model. The exercise price of the outstanding options is $8,771,300.00. The following table details the outstanding warrants over ADSs and ordinary shares as at 31 December and also the movement in the year: *Number and original price of warrants have been adjusted to reflect the share consolidation and ratio change of ADS’s to ordinary shares that occurred on 24 March 2023 and the ratio change of ADS’s to ordinary shares on 26 September 2022, 5 July 2023 and 4 October 2024. 10. Share capital and reserves At a General Meeting on 22 November 2024, shareholders approved the subdivision and redesignation of the Company’s Issued Ordinary Shares of £0.001 each into to one Ordinary Share of £0.00005 each and 19 ‘C’ Deferred Shares of £0.00005 each. The ‘C’ Deferred Shares have limited rights and are effectively valueless. On 22 July 2024 the Company entered into Registered Direct Offering, as insufficient share premium was recognised in relation to the transaction the remaining transaction costs have been charged to retained earnings. On 4 October 2024 the Company effected a ratio change in the number of Ordinary Shares represented by ADSs from 400 Ordinary Shares per ADS to 10,000 Ordinary Shares per ADS. During the year the Company issued the following warrants over ADSs, and these were recognised in the warrant reserve until exercise: Numbers of warrants and related exercise prices are after the impact of the ADS ratio changes on 4 October 2024. In accordance with the Articles of Association for the Company adopted on 22 November 2024, the share capital of the Company consists of an unlimited number of ordinary shares of nominal value £0.00005 each. Ordinary and deferred shares were recorded as equity. Rights attaching to the shares following the incorporation of Biodexa Pharmaceuticals plc Shares classified as equityThe holders of ordinary shares in the capital of the Company have the following rights: (a) to receive notice of, to attend and to vote at all general meetings of the Company, in which case shareholders shall have one vote for each share of which he is the holder; and, (b) to receive such dividend as is declared by the Board on each share held. The holders of both classes of deferred shares in the capital of the Company: (a) shall not be entitled to receive notice of or to attend or speak at any general meeting of the Company or to vote on any resolution to be proposed at any general meeting of the Company; and (b) shall not be entitled to receive any dividend or other distribution of out of the profits of the Company. In the event of a distribution of assets, the deferred shareholders shall receive the nominal amount paid up on such share after the holder of each ordinary share shall have received (in cash or specie) the amount paid up or credited as paid up on such ordinary share together with an additional payment of £100 per share. The Company has the authority to purchase the deferred shares and may require the holder of the deferred shares to sell them for a price not exceeding 1p for all the deferred shares. 11. Related party transaction The Directors consider there to be no related party transactions during the periods reported other than Directors Remuneration. 12. Contingent liabilities The Company entered into an Arrangement Agreement with Bioasis on 13 December 2022 as amended on 18 December 2022. Under the agreement the Company agreed to acquire the entire issued share capital of Bioasis for consideration of, in aggregate, approximately C$7.4 million (c£4.4 million). The agreement was subject to shareholder approval. On January 23, 2023 at the General Meeting to approve the Arrangement Agreement none of the special resolutions were passed and, accordingly, the acquisition of Bioasis did not proceed. Under the agreement the Company agreed to reimburse Bioasis US$225,000 for expenses relating to the transaction should the Company’s shareholders not approve the transaction. On March 3, 2023 the Company advised Bioasis that it would offset this liability against the $500,000 loan it advanced to them during December 2022 and January 2023. As at 31 December 2023 and 31 December 2022 the Company had a contingent liability of $225,000 in relation to this potential liability. As at 31 December 2024 the Company no longer believes it has a contingent liability. 13. Events after the reporting date On 17 January, 2025, we entered into an ELOC with C/M Capital Master Fund LP (“C/M”) pursuant to which we have the right, but not the obligation, to sell to C/M, and C/M is obligated to purchase, up to $35.0 million of newly issued ADSs for a period of 36 months from Commencement Date. As consideration for the Seller Shareholder’s execution and delivery of the Purchase Agreement, we have agreed to pay to the Selling Shareholder a Commitment Fee of $875,000 in cash or in ADSs. At any time after the Commencement Date, we may direct C/M to purchase a specified number of ADSs, or a Fixed Purchase, not to exceed $200,000, at a purchase price equal to the lesser of 95% of (i) the daily volume weighted average price, or VWAP, of the Depositary Shares for the five trading days immediately preceding the applicable Purchase Date for such Fixed Purchase and (ii) the lowest sale price of an ADS Share on the trading day immediately preceding the Purchase Date. In addition, we may also direct C/M to purchase an additional number of ADSs in an amount up to the VWAP Purchase Maximum Amount (as defined in the Purchase Agreement), or a VWAP Purchase, at a purchase price equal to the lesser of 95% of (i) the closing price of an ADS on the trading day immediately preceding the applicable VWAP Purchase Date and (ii) the VWAP during the period on the applicable VWAP Purchase Date beginning at the opening of trading and ending at the VWAP Purchase Termination Time (as defined in the Purchase Agreement). Lastly, we may also direct C/M to purchase an Additional VWAP Purchase at a purchase price equal to the lesser of 95% of (i) the closing price of an ADS on the trading day immediately preceding the applicable Additional VWAP Purchase Date and (ii) the VWAP during the Additional VWAP Purchase Period (as defined in the Purchase Agreement) on the applicable Additional VWAP Purchase Date. Under the Purchase Agreement, the aggregate amount of Purchase Shares submitted in any single or combination of VWAP Purchase notices and/or Additional VWAP Purchase notices on a particular date require a payment from C/M to us not exceeding $2.5 million. C/M is not obligated to purchase any ADSs pursuant to the Purchase Agreement if, when aggregated with all other securities then beneficially owned by C/M would result in C/M beneficially owning Ordinary Shares (represented by Depositary Shares) in excess of 9.99% of the then-outstanding Ordinary Shares. The net proceeds under the Purchase Agreement to us will depend on the frequency and prices at which we sell Depositary Shares to C/M. We expect that any proceeds received by us from such sales to C/M will be used to fund our development programs, for working capital and other general corporate purposes.
Investor releaseQuarter not tagged2025-03-19With Fast Track Designation in Hand, a Successful Protocol Discussion with FDA, and CROs in Place, Biodexa is on Track to Initiate its Funded Phase 3 Trial in FAP Next Quarter
ACCESS Newswire
With Fast Track Designation in Hand, a Successful Protocol Discussion with FDA, and CROs in Place, Biodexa is on Track to Initiate its Funded Phase 3 Trial in FAP Next Quarter
CARDIFF, UNITED KINGDOM / ACCESS Newswire / March 19, 2025 / 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, is making progress in readying the launch of a phase 3 trial for eRapa, its proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP). In just the last few weeks, Biodexa received Fast Track designation from the FDA, conducted a successful Type C (pre-Phase 3 protocol finalization) meeting with the FDA and appointed a clinical research organization (CRO) to conduct the European component of its registrational Phase 3 trial. A CRO for the U.S. component was appointed earlier. FAP is an inherited condition that puts people at a much greater risk of developing colon cancer. With FAP, hundreds or thousands of precancerous polyps grow throughout the gastrointestinal tract. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. People with FAP, which usually appears in the patient's mid-teens, end up eventually having their entire colon removed. If left untreated there is a high likelihood the person will develop colon or rectum cancer. Biodexa hopes to help with eRapa, a proprietary oral tablet formulation of rapamycin, also known as sirolimus, which slows down the mTOR (mammalian Target Of Rapamycin) protein. "Too much mTOR has been linked to cancer and has been shown to be over-expressed in FAP polyps - thereby underscoring the rationale for using an mTOR inhibitor like eRapa to treat FAP", noted Stephen Stamp, Biodexa's CEO and CFO. Phase 3 Study Commencing Next Quarter Biodexa, which has already received Fast Track designation by the FDA for the drug, completed a successful Phase 2 trial of eRapa, demonstrating a 17% median decrease in overall polyp burden and an overall non-progression rate of 75%. Biodexa said patients in cohort 2, the dosage regimen that will be used in Phase 3, experienced an 89% non-progression rate and 29% median reduction in polyp burden at 12 months compared with baseline. The Phase 3 study will be a double-blind placebo-controlled design recruiting approximately 168 high-risk patients diagnosed with germline or ph…Read full documentShow less
CARDIFF, UNITED KINGDOM / ACCESS Newswire / March 19, 2025 / 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, is making progress in readying the launch of a phase 3 trial for eRapa, its proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP). In just the last few weeks, Biodexa received Fast Track designation from the FDA, conducted a successful Type C (pre-Phase 3 protocol finalization) meeting with the FDA and appointed a clinical research organization (CRO) to conduct the European component of its registrational Phase 3 trial. A CRO for the U.S. component was appointed earlier. FAP is an inherited condition that puts people at a much greater risk of developing colon cancer. With FAP, hundreds or thousands of precancerous polyps grow throughout the gastrointestinal tract. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. People with FAP, which usually appears in the patient's mid-teens, end up eventually having their entire colon removed. If left untreated there is a high likelihood the person will develop colon or rectum cancer. Biodexa hopes to help with eRapa, a proprietary oral tablet formulation of rapamycin, also known as sirolimus, which slows down the mTOR (mammalian Target Of Rapamycin) protein. "Too much mTOR has been linked to cancer and has been shown to be over-expressed in FAP polyps - thereby underscoring the rationale for using an mTOR inhibitor like eRapa to treat FAP", noted Stephen Stamp, Biodexa's CEO and CFO. Phase 3 Study Commencing Next Quarter Biodexa, which has already received Fast Track designation by the FDA for the drug, completed a successful Phase 2 trial of eRapa, demonstrating a 17% median decrease in overall polyp burden and an overall non-progression rate of 75%. Biodexa said patients in cohort 2, the dosage regimen that will be used in Phase 3, experienced an 89% non-progression rate and 29% median reduction in polyp burden at 12 months compared with baseline. The Phase 3 study will be a double-blind placebo-controlled design recruiting approximately 168 high-risk patients diagnosed with germline or phenotypic FAP. It is expected the study will be conducted in about 30 clinical sites across the U.S. and Europe. That Phase 3 trial is getting closer to a launch following on the heels of what the company says was a successful Type C meeting with the FDA. During the meeting with FDA representatives from both the gastroenterology and oncology divisions, Biodexa and the FDA discussed the company's statistical plan, the safety database and a composite endpoint for the Phase 3 study. As a result of that meeting, Biodexa believes it has a clear path forward for the initiation of the U.S. Phase 3 study next quarter. "With no approved products for FAP, we were pleased to collaborate with FDA and our U.S. CRO, LumaBridge, to define the regulatory pathway for eRapa in FAP," said Gary Shangold, MD, Chief Medical Officer of Biodexa. "Agreement on the composite endpoint, in particular, clears the path to finalize the protocol, recruit the U.S. sites and begin patient enrollment." The Phase 3 program is substantially funded by a $17 million grant from the Cancer Prevention Research Institute of Texas, which has been matched 1:2 by Biodexa contributions of $8.5 million for a total funding of $25.5 million. U.S. and European CROs On Board Biodexa previously appointed LumaBridge to conduct the study in the U.S. and just tapped Precision for Medicine as the CRO to conduct the European component of the upcoming registrational Phase 3 study of eRapa in FAP. LumaBridge was founded in 2014 to help advance the development of novel immunotherapies in the fight against cancer. Building on the founders' 3 decades of combined experience in academic and military research, LumaBridge offers full outsourced clinical trial support across the entire timeline of clinical development, including consultation on clinical development strategy, as well as special capabilities in military research. Over the 11 years since its founding, LumaBridge has made a significant impact in the advancement of immuno-oncology therapies, supporting a substantial number of trials and projects for over 30 clients. Precision for Medicine is focused on rare diseases and has a stated mission to accelerate the pathway for complex drug development. Precision for Medicine has been conducting studies for over twenty years and according to Biodexa is known for its high-caliber, therapeutically specialized staff, experienced scientists and physicians, advanced specialty laboratories and problem-solving capabilities. Precision for Medicine has conducted 333 clinical trials in rare diseases and employs over 700 team members in Europe across 11 locations, Biodexa shared in a press release. With thousands of new cases of FAP each year, people in Europe and America suffering from this disease need relief. Biodexa is aiming to deliver that, and with its phase 3 study about to get underway, that may happen sooner rather than later. Featured photo by National Cancer InstituteonUnsplash. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Click here for more information on Biodexa Pharmaceuticals. Contact:Stephen Stamp, CEO, [email protected] Important notice, please read: The information and statistical data contained herein may contain forward-looking statements that reflect the company's intentions, expectations, assumptions, or beliefs concerning future events, including, but not limited to, expectations with respect to FDA and other regulatory bodies approval of new products, technology, and product development milestones, the ability of the company to leverage its product development and negotiate favorable collaborative agreements, the commencement of sales, the size of market opportunities with respect to the company's product candidates and sufficiency of the company's cash flow for future liquidity and capital resource needs and other risks identified in the Risk Factor Section of the company's Annual Report and any subsequent reports filed with the SEC. We do not undertake to advise you as to any change in this information. The forward-looking statements are qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the company's research and development programs. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Biodexa Pharmaceuticals PLC to provide investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein. SOURCE: Biodexa Pharmaceuticals PLC View the original press release on ACCESS Newswire

