On September 11, 2026 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical-stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers, reported its unaudited interim results for the six months ended June 30, 2026 which will also be made available on the Company’s website at View Source .
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OPERATIONAL HIGHLIGHTS
The Company announced the following in the six months ended June 30, 2026:
· In-license of MTX240 (formerly OPB-171755) from Otsuka Pharmaceutical Co., Limited in February 2026 with a nominal upfront payment.
· Launch of a global Early Access Program for eRapa for FAP Patients through a strategic partnership with Tanner Pharma Group in March 2026.
· Approval from Health Canada to expand the Serenta trial into Canada in June 2026.
· Promotion of Fiona Sharp to Chief Financial Officer and Company Secretary, also joining the Board of Directors from January 2026.
Post period end:
· On July 1, 2026, the Company completed a fundraise raising gross proceeds of $3.5 million through a combination of a registered direct offering, warrant inducement and PIPE offering.
· As of the date of publication, 92 subjects, of a planned 168 subjects, have been enrolled in the Serenta trial.
FINANCIAL HIGHLIGHTS
· R&D costs increased to £2.92 million in 1H26 (1H25: £1.67 million) reflecting increased expenditure on the Serenta trial and manufacturing costs on the newly in-licensed MTX240 program.
· Administrative costs decreased to £1.74 million (1H25: £2.38 million) primarily as a result of foreign exchange movements.
· Net cash used in operating activities (after changes in working capital) in 1H26 was £4.61 million (1H25: £3.30 million).
· The Company’s cash balance at June 30, 2026 was £3.23 million.
Commenting, Stephen Stamp, CEO , said "We accomplished two main things in the first six months.
First, building on the advice we received from regulators, we accelerated enrolment into our registrational Phase 3 trial of eRapa in FAP. There are no approved therapeutics for FAP and passing the 50% enrolment in early August puts us significantly ahead of any competitive development programs.
Second, in-licensing MTX240 for GIST rounds out our GI cancer portfolio and, given its unique mechanism of action, has the potential to treat GIST patients irrespective of their KIT or PDGFR mutation. The Phase 1b/2a trial we are working to initiate is designed to establish a safe and effective dose as well as an efficacy signal before the end of 2027.
As always, financing remains a challenge for companies of our size."
CHIEF EXECUTIVE’S REVIEW
Our main focus in the first half of 2026 was on (1) expanding our registrational Phase 3 trial of eRapa in Familial Adenomatous Polyposis ("FAP") in Europe, and (2) initiating activities for the re-start of a Phase 1 trial of MTX240 in gastrointestinal stromal tumors ("GIST") which was in-licensed in early February 2026.
R&D update
In the first half of 2026 we progressed our Phase 3 trial of eRapa in FAP and added MTX240, a novel Phase 1 ready asset for the treatment of GIST. As of today, we have two active sponsored programs and two investigator initiated programs:
MTX230 – 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.
Familial Adenomatous Polyposis
FAP is characterized by a proliferation of polyps in the colon, duodenum 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 gastrointestinal tract remain the standard of care. If untreated, FAP almost always leads to colorectal cancer. 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 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.
Following encouraging results from an open label Phase 2 study, a Type C meeting with the FDA and scientific advice from the EMA, we initiated a registrational Phase 3 trial (NCT06950385) of eRapa in June 2025. The trial, branded "Serenta" is a double-blind placebo-controlled design, recruiting 168 high risk subjects diagnosed with germline or phenotypic FAP. The primary clinical endpoint is first progression free survival event which will comprise composite endpoints including major surgery. As of the date of publication, 92 subjects have been recruited in the trial across 19 centers in the US and 10 centers in five European countries. Two centers in Canada are expected to begin enrolling in 4Q26.
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 investigator initiated two-center, double-blind, placebo-controlled Phase 2 trial 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, is expected to read out in Q426.
MTX240 – molecular glue
We in-licensed global rights (excluding Japan) to MTX240 from Otsuka Pharmaceutical Co, Limited ("Otsuka") in early February 2026. Discovered by Otsuka and originally coded OPB-171755, MTX240 is a novel molecular glue we intend to develop for the treatment of GIST. Its unique mechanism of action 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 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 kinase inhibitors for GIST and by triggering cell death through an alternative pathway MTX240 is designed to overcome the resistance mechanisms that render TKI-resistant GISTs refractory to conventional kinase inhibitors.
Gastrointestinal Stromal Tumors (GIST)
GIST is a rare gastrointestinal malignancy affecting approximately 3,000-4,000 patients annually in the US, 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 2032, 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.
We are in the process of initiating activities for the re-start of a Phase 1 dose escalation and dose optimization trial, most likely an open label trail in GIST patients with no available therapeutic options. GMP clinical trial supplies are being developed and manufactured by Syngene International Limited. In the meantime, we are preparing regulatory submissions for a pre-IND meeting with the FDA.
MTD228 – Tolimidone
Tolimidone was originally discovered by Pfizer and was developed through Phase 2 for the treatment of gastric ulcers. 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")
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. Tolimidone appeared to induce proliferation in beta cells isolated from human cadavers. 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.
An ongoing Phase 2a investigator initiated trial 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.
1H26 FINANCIAL REVIEW
The unaudited results for the six months ended June 30, 2026 are discussed below:
Key performance indicators (KPIs):
1H 2026 1H 2025 Change
R&D costs £2.92m £1.67m 75%
R&D as % of operating costs 63% 41% n/a
Net cash inflow/(outflow) for the period (£5.31m) £2.37m n/m
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 1H26 and 1H25, analyzed by development project indication were as follows:
Six months ended June 30 2026 2025
£’000 £’000
eRapa
Familial Adenomatous Polyposis 1,420 251
Non-muscle Invasive Bladder Cancer 2 127
Total eRapa 1,422 378
MTX240
GIST 295 -
Total MTX240 295 -
Tolimidone
Type 1 Diabetes 49 270
Total tolimidone 49 270
MTX110 (Panobinostat)
Diffuse Midline Glioma - -
Recurrent Glioblastoma 155 14
Medulloblastoma - -
Total MTX110 (Panobinostat) 155 14
Other preclinical - 1
R&D overheads 995 1,002
Total R&D 2,916 1,665
MTX230 eRapa Familial Adenomatous Polyposis costs are shown above net of grant income. For the six months ended June 30, this is analyzed as follows:
For period to 30 June 2026 2025
£’000 £’000
Grant income (2,818 ) (2,107 )
Gross costs 4,238 2,358
Net charge to income statement 1,420 251
% costs allocated against CPRIT grant 66 % 89 %
R&D costs in 1H26 increased by £1.25 million, or 75%, to £2.92 million compared with £1.67 million in 1H25. R&D costs as a percentage of total operating costs increased to 63% from 41%. The increase was predominantly due to increased activity on the MTX230 Serenta clinical trial, which increased by £1.04 million, and manufacturing costs on the Company’s new MTX240 program of £0.30 million. The percentage of MTX230 (eRapa) costs offset against grant funding during the period was 66%, compared with 89% in 1H25. The Company anticipates that this percentage will be 67% over the life of the grant.
Administrative Costs
Administrative costs in 1H26 decreased by £0.64 million, or 27%, to £1.74 million from £2.38 million in 1H25. The decrease was driven primarily by foreign exchange movements, with a gain of £0.08 million recognized in 1H26 compared with a charge of £0.40 million in 1H25. Professional fees also decreased by £0.12 million in the period.
Finance Income and Expense
Finance income in 1H26 included gains in respect of an equity-settled derivative financial liability of £2.38 million (1H25: £0.15 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 and discounted interest on deferred consideration.
Cash Flows
Cash outflows from operating activities in 1H26 were £4.61 million compared to £3.30 million in 1H25, driven by a net loss of £1.84 million (1H25: £3.81 million) and after negative working capital of £0.55 million (1H25: negative £0.04 million) and other negative non-cash items totaling £2.22 million (1H25: positive £0.24 million).
Net cash used in investing activities in 1H26 was £0.63 million (1H25: outflow of £0.34 million). This comprised £0.71 million of cash outflows relating to the purchase of the MTX240 license from Otsuka for total consideration of £0.37 million and the payment of deferred consideration on the eRapa license of £0.34 million (1H25: £0.37 million), offset by £0.09 million of interest received (1H25: £0.04 million).
Net cash used in financing activities in 1H26 was £0.07 million (1H25: inflow of £6.01 million), reflecting payments on lease liabilities.
Overall, cash decreased by £5.31 million in 1H26 compared with an increase of £2.37 million in 1H25. This resulted in a cash balance at June 30, 2026 of £3.23 million compared with £4.04 million at June 30, 2025 and £8.53 million at December 31, 2025.
Financing
On June 30, 2026, the Company entered into a securities purchase agreement utilizing its Registration Statement on Form F-3 to issue 82,809 ADSs and 200,143 pre-funded ADS warrants. In a concurrent Private Placement the Company agreed to issue 350,877 pre-funded ADS warrants. Each ADS was sold at an offering price of US$2.85, and each Pre-Funded Warrant was sold at an offering price of US$2.8499. In connection with the securities purchase agreement the Company agreed, upon receipt of Shareholder Approval, to issue 282,952 Series M Warrants and 701,754 Series N Warrants. The Series M and Series N Warrants have an exercise price of US$2.85 per ADS and have a term of five years from the date Shareholder Approval is obtained.
In addition, the Company entered into a warrant exercise inducement letter with a holder of Series L Warrants to purchase 609,756 ADSs at a reduced exercise price of US$2.85 per ADS. In consideration, the Company agreed, upon receipt of Shareholder Approval, to issue Series O Warrants to purchase an aggregate of 1,219,512 ADSs upon exercise of the existing warrants. The Series O Warrants have an exercise price of US$2.85 per ADS and a term of five years from the date Shareholder Approval is obtained.
The above transactions completed on July 1, 2026 and raised $3.5 million of gross proceeds.
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, 2026, the Group incurred a consolidated loss of £1.84 million (1H25: £3.81 million) and negative cash flows from operating activities of £4.61 million (1H25: £3.30 million). As of June 30, 2026, the Group had accumulated deficit of £157.60 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 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 realization of assets and the satisfaction of liabilities in the normal course of business.
As at June 30, 2026, the Group had cash and cash equivalents of £3.23 million. On July 1, 2026, the Company completed the financing transaction described above, raising gross proceeds of $3.5 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 during Q4 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 ("ELOC") entered into in 2025, 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 30 June 2026 $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 of alternative courses of action to finance the Group would be successful.
The Directors have also considered the potential impact of Nasdaq’s proposed minimum market value requirement. Although implementation of the proposed rule has been stayed pending full Commission review, Biodexa’s current market capitalization is below the announced $5 million threshold. If implemented, or if the Company otherwise failed to maintain compliance with Nasdaq listing requirements, this could adversely affect the Company’s ability to raise funds, reduce investor appetite and limit the strategic value of the Company’s Nasdaq listing in connection with potential merger or reverse merger opportunities.
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, the Group will no longer be a going concern. In such circumstances, the Group 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, assets would be stated at net realizable value, and liabilities would be accelerated to current liabilities.
(Press release, Biodexa Pharmaceuticals, SEP 11, 2026, View Source [SID1234670755])