Biodexa announces the allowance of American patents covering the preparations of oral rapamicin nanoparticles (“Erapa”) and use

February 24, 2025

BIODEXA announces the allowance of American patent coverage

Preparations of oral rapamicin nanoparticles (“Erapa”) and use

Biodexa intends to initiate a recording study in Phase 3 of Erapa in

Family adenomatous polyposis (FAP) next quarter

Biodexa Pharmaceuticals PLC (“Biodexa” or “Company”) (NASDAQ: BDRX), a biopharmaceutical company in a clinical stage that develops an innovative products for the treatment of diseases with unsatisfied medical needs, today announced that the American patent and the Office of the brand A permit the permit license permit has the patent application no. 17/391.495 entitled “Preparations and uses of nanoparticles with oral rapamicin”, which was licensed exclusively at Biodexa by Rapamycin Holdings, Inc. D/B/A Emtora Biosciences, together with other patents, in a transaction that closed in April 2024. The patent is to be issued on March 4, 2025 and, in the absence of any patent extensions, they are expected to expire in March 2034.

Stephen Stamp, CEO and CFO of Biodexa, commented “FDA has already given the designation of orphan drugs for our most advanced program, Erapa in FAP, which gives the exclusivity of the seven years in the US approval. This patent offers an additional layer of Exclusivity welcome for exclusivity The new drug formulation erase while investigating additional indications.

About Erapa

Erase is a formulation of the oral rapamicin tablet, also known as Syrolimus. Rapamicin is a mtor (mAmmalian TArget Af Rapamicin inhibitor). Mtor has proven to have a significant role in the signal path that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis³. It is important that Mtor has proven to be excessively expressed in FAP polyps – thus emphasizing the reason for using a strong and safe MTOR inhibitor, such as Erapa, to treat FAP. Rapamicin is approved in the US for rejection of organs in renal transplantation as Rapamune® (PFIZER). By using pH sensitive nanotechnology and polymers, the EPA is designed to approach poor bioavailability, variable pharmacokinetics and toxicity, in general, associated with currently available rapamicin forms. The convincing data of six months from a phase 2 study on Erapa in FAP were presented at the Digestive Disease Week in April 2024 and 12 months were presented in Insight, Barcelona in June 2024. A 3th phase study in approximately 30 The US and Europe centers are expected to start recruiting the next quarter. Phase 3 program is substantially funded by a subsidy of $ 17.0 million from the Cancer Institute in Texas (CPRIT), which was associated with contributions of the company of $ 8.5 million.

Institute for Cancer Prevention and Research in Texas

So far, CPRIT has awarded $ 2.9 billion in subsidies to Texas research institutions through its academic research, prevention and product development programs. CPRIT recruited 237 distinguished researchers, supported the establishment, extension or relocation of 43 companies in Texas and generated over $ 5.7 billion in additional public and private investments. CPRIT funding has advanced scientific and clinical knowledge and has provided 7.4 million life rescue and early detection cancer services, which have reached Texani from all 254 counties. On November 5, 2019, Voters in Texas overwhelmed a constitutional amendment to provide additional $ 3 billion for CPRIT for a total investment of $ 6 billion in cancer research and prevention. Learn more at https://cprit.texas.gov/.

About Biodexa Pharmaceuticals PLC

Biodexa Pharmaceuticals PLC (listed on Nasdaq: BDRX) is a biopharmaceutical company in a clinical stage that develops an innovative products for the treatment of diseases with unsatisfied medical needs. The main development programs of the company include the EPAPA, developing for family adenomatous polyposis and non-muscular invasive bladder cancer; Tolimidone, developing for the treatment of type 1 diabetes; and MTX110, which is studied in aggressive indications of rare/orphan brain cancer.

Erase is a formulation of the oral rapamicin tablet, also known as Syrolimus. Rapamicin is a mtor (mAmmalian TArget Af Rapamicin inhibitor). It has been shown that MTOR has a significant role in the signal path that regulates cellular metabolism, growth and proliferation and is activated during tumorige.

Tolimidone is an oral, powerful and selective inhibitor of Lyn Kinasei. Lyn is a member of the SRC family of Tirosine Kinases, which is mainly expressed in hematopoietic cells, in neuronal tissues, liver and adipose tissue. Tolimidone demonstrates glycemic control by sensitizing insulin in diabetes animal models and has the potential to become the first agent of blood glucose.

The MTX110 is a solubilized formulation of the Histone deacethylase inhibitor (HDAC), Panobinostate. This owner formulation allows the delivery of the product by improved delivery with convection (CED) at chemotherapeutic doses directly on the tumor site, by passionate about blood-brain and potential barrier avoiding systemic toxicity.

Biodexa is supported by three own technologies for drug administration, focused on improving bio-livi-livation and distribution of drug bio-distribution. Biodexa’s headquarters and research and development facility is in Cardiff, UK. For more information, visit www.biodexapharma.com.

Prospective statements

Certain statements in this announcement may be “prospective statements” in the sense of legislation in the United Kingdom and/or the United States. Such statements are made in accordance with the provisions regarding the safe port of the private law of the 1995 private disputes and are based on the faith or interpretation of the management. It can be identified by using words such as “plans”, “expectations” or “do not anticipate” or “believe”, or variations of such words and phrases or statements that certain actions, events or results “,” can ” , “Could”, “would be”, “could” or “will be taken”, “appear” or “to be done”. Prospective statements and information are subject to various known and unknown risks and uncertainties, many of them being beyond the ability of the company to control or predict, which can determine their real results, performance or achievements are significantly different from those expressed or involved by This and are developed based on assumptions about such risks, uncertainties and other factors established here.

Reference should be made to those documents that Biodexa will submit from time to time or ads that can be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could determine the real results. to differ significantly material from those contained in any pros or prospective statements. These prospective statements only speak from the date of this ad. All subsequent written and oral prospective statements by or in connection with Biodexa are expressly qualified entirely by the above -mentioned statements. Unless it can be requested in accordance with the relevant laws in the United States, Biodexa assumes no obligation to update or review public in the event of prospective statements due to new information, future events or events that occur.