Biodexa Announces Partnership With Syngene To Manufacture MTX240 GMP Clinical Trial Supplies

Biodexa Announces Partnership with Syngene
To Manufacture MTX240 GMP Clinical Trial Supplies

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) (“Biodexa” or“Company”), a clinical stage biopharmaceutical company developing a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers, is pleased to announce that it has partnered with Syngene International Ltd (BSE: 539268, NSE: SYNGENE) (“Syngene”) for the manufacture of both MTX240 active pharmaceutical ingredient and dosage form.

Commenting, Dan Palmer, Vice President, Technology at Biodexa said“We are delighted to be partnering with Syngene for the second time. Syngene manufactured tolimidone dosage form for us on time and on budget and, given the license for MTX240 from Otsuka was only signed in early February, they have once again demonstrated their responsiveness and flexibility in designing a program to manufacture GMP product within only a few weeks”

About MTX240, its Unique Mechanism of Action, Clinical Rationale and Next Steps
Molecular glue technology represents a novel approach that induces targeted protein interactions, offering a distinct mechanism of action to conventional kinase inhibitors for rare oncology indications.

Gastrointestinal Stromal Tumors (“GIST”) is mostly driven by activating mutations in the KIT and/or PDGFR receptor tyrosine kinase. While tyrosine kinase inhibitors (TKIs) such as imatinib, sunitinib, and regorafenib are reported to have significantly improved outcomes for GIST patients, resistance almost always develops through secondary KIT or PDGFR mutations or activation of alternative signalling pathways. This represents a substantial clinical challenge with limited therapeutic options for patients once they have cycled through the available TKIs.

MTX240 acts as 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 signalling. By triggering cell death through this alternative pathway, MTX240 is designed to overcome the resistance mechanisms that render TKI-resistant GISTs refractory to conventional kinase inhibitors. This novel mechanism may provide clinical benefit for a significant proportion of GIST patients, not only those who have developed resistance to TKIs.

Biodexa is planning to file an IND and initiate a Phase 1b/2a study towards the end of the year. The study will likely be in two parts: a dose escalation part to establish a safe and tolerable dose followed by an expansion part designed to generate an efficacy signal in TKI-resistant GIST patients.

For more information, please contact:

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, 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 signalling 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 signalling.

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 glycaemic 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 .

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.

MENAFN02042026004107003653ID1110935330