Full Press Release Details
Biodexa Pharmaceuticals PLC
("Biodexa" or the "Company" or, together
with its subsidiaries, the "Group")
Preliminary Results for the Year Ended 31 December 2023
Biodexa Pharmaceuticals PLC (NASDAQ: BDRX), a clinical stage
biopharmaceutical company developing a pipeline of products aimed at primary and metastatic cancers of the brain, announces its audited
preliminary results for the year ended 31 December 2023.
For more information, please contact:
| Biodexa Pharmaceuticals PLC |
| Stephen Stamp, CEO, CFO |
| Tel: +44 (0)29 2048 0180 |
| www.biodexapharma.com |
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 programmes include tolimidone, under development as a novel agent for the
treatment of type 1 diabetes and MTX110, which is being studied in aggressive rare/orphan brain cancer indications.
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 tumour, by-passing the blood-brain barrier and potentially avoiding
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
are forward-looking statements or information (collectively, forward-looking statements). Biodexa hereby provides cautionary statements
identifying important factors that could cause the actual results to differ materially from those projected in the forward-looking statements.
Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance
(often, but not always, through the use of words or phrases such as "may", "is expected to", "anticipates",
"estimates", "intends", "plans", "projection", "could", "vision",
"goals", "objective" and "outlook") are not historical facts and may be forward-looking and may involve
estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in the
forward-looking statements.
By their nature, forward-looking statements involve numerous
assumptions, inherent risks and uncertainties, both general and specific, which contribute to the possibility that the predicted outcomes
may not occur or may be delayed. The risks, uncertainties and other factors many of which are beyond the control of Biodexa, that could
influence actual results include, but are not limited to: a limited operating history; regulatory risks; substantial capital and liquidity
requirements; financing risks and dilution to shareholders; competition; reliance on management and dependence on key personnel; conflicts
of interest of management; exposure to potential litigation, and other factors beyond the control of Biodexa.
Forward looking statements are based on estimates and assumptions
made by management in light of their experience of historical trends, current conditions and expected future developments, as well as
factors that are believed to be appropriate. Such factors include, among others, Biodexa's future product revenues, stage of development,
additional capital requirements, risks associated with the completion and timing of clinical trials and obtaining regulatory approval
to market Biodexa's products, the ability to protect its intellectual property, dependence upon collaborative partners, changes
in government regulation or regulatory approval processes and rapid technological change in the industry. These factors should be considered
carefully and readers are cautioned to not place undue reliance on such forward-looking statements.
Further, any forward-looking statement
speaks only as of the date on which such statement is made, and, except as required by applicable law, Biodexa undertakes no obligation
to update any forward-looking statement to reflect events or circumstances after the date on which such statements are made or to reflect
the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all such
factors and to assess in advance the impact of each such factor on the business of the Company or the extent to which any factor, or combination
of factors, may cause actual results to differ materially from those contained in any forward-looking statement.
Comparisons of results for current and any prior periods are
not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as
historical data. You should, however, review the factors and risks we describe in the reports we will file from time to time with the
US Securities and Exchange Commission after the date of this announcement. As a result of these factors, we cannot assure you that the
forward-looking statements in this announcement will prove to be accurate. Furthermore, if our forward-looking statements prove to be
inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should
not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in
any specified timeframe, or at all.
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 Type 1 diabetes and rare / orphan brain cancers.
The Company de-listed from the AIM market as of 26 April 2023.
In the course of seeking additional funding for the Company,
it became clear that raising significant funds for a drug delivery platform company was going to be difficult, if not impossible, in the
then prevailing financial markets. Accordingly, we decided to re-position the Company as a therapeutics company and began looking for
assets to complement our MTX110 programmes.
Following the re-positioning of the Company, our priorities
for 2024 reflect our modified strategy as follows:
| Strategic Imperatives | Progress in 2023 | Priorities for 2024 |
| Advance our clinical -stage assets through to proof-of-concept data | We announced the completion of recruitment into Cohort A of our MAGIC-G1 study of MTX110 in patients with recurrent glioblastoma (rGBM). In an Investigator Initiated Trial, Columbia University completed recruitment of a Phase I study of MTX110 in patients with Diffuse Midline Glioma (DMG). | In respect of our Phase I study in rGBM, deliver interim safety and efficacy data (in the form of Progression Free Survival data) in respect of Cohort A patients and begin recruitment of Cohort B patients. Initiate recruitment of a Phase IIa dose confirmation study of tolimidone in Type 1 diabetes patients. Seek an IND from FDA to commence a Phase II study of MTX110 in DMG. |
| Develop and broaden our drug development pipeline | We in-licensed tolimidone, a Phase II ready asset with very substantial preclinical and toxicology data which has been studied in over 700 patients. In preclinical experiments, tolimidone showed potential to be disease modifying in Type 1 diabetes. We initiated a new research programme, coded MTD217, to explore the potential for MTX110 in combination with an OXPHOS inhibitor for the treatment of Leptomeningeal Disease, a severe complication of solid cancers with metastasis in the leptomeningeal space of the CNS. | Generate in vitro data to support the disease modifying potential of tolimidone in Type 1 diabetes. Generate in vitro and in vivo data to demonstrate the effectiveness of MTD217 in Leptomeningeal Disease models. Seek additional pre-IND and/or clinical-stage assets to acquire or in-license. Expand further our patent portfolio to cover new inventions and divisionals to strengthen existing patent families. |
| Provide a healthy and stimulating environment in which our staff members can continue to thrive | We have been compliant with ISO 9001 since 2014. Implement the new COSHH assessment procedures developed in 2023. | Continue to monitor third party advice and regulation to maintain a safe environment for our staff members. Develop individualised learning programmes for staff members through participation in conferences, webinars and/or training programmes. |
In order to make the Company more investable and secure additional
financing, the Board decided to re-position the Company as a therapeutics (as opposed to drug delivery) company in early 2023. As a result,
the delivery of proof-of-concept clinical data is the primary focus of our business model going forward.
Our intention is to build a balanced portfolio of clinical-stage
development assets, ideally with a focus on rare / orphan indications. Tolimidone, which was in-licensed in December 2023, is a Phase
II ready asset which we intend to develop for Type 1 diabetes. MTX110 is currently in Phase I development for three rare / orphan brain
Our aim is to develop our clinical assets to proof of concept
stage before securing partners to undertake the most expensive, later stage development.
We do not intend to establish
our own manufacturing capabilities. For clinical trial material we utilise GMP-certified contract manufacturers.
Once proof-of-concept has been established, we intend to seek
to 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, four of
which are at clinical stage, as follows:
CLINICAL-STAGE ASSETS
Tolimidone was originally discovered
by Pfizer Inc. ("Pfizer") and was developed through Phase II for the treatment of gastric ulcers. Pfizer undertook a broad
pre-clinical program 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 II. 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.
We intend to develop tolimidone for the treatment of Type-1
diabetes ("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
As a first step in the planned continued