Sirolimus

LONDON--( BUSINESS WIRE )-- Elixir Medical , a developer of disruptive technologies to treat cardiovascular disease, today announced the INFINITY-SWEDEHEART Randomized Controlled Trial (RCT) comparing the novel DynamX ® Coronary Bioadaptor System with the contemporary Resolute Onyx ™ zotarolimus drug-eluting stent (DES) met its primary endpoint of target lesion failure (TLF) non-inferiority (2.35% versus 2.77%; p<0.001) at 12 months. The data were presented as a late-breaking Hot Line session at the European Society of Cardiology (ESC) Congress 2024 in London. “ The DynamX bioadaptor represents a significant clinical advancement in the treatment of coronary artery disease with a unique mechanism of action six months following the percutaneous coronary intervention (PCI) procedure,” said principal investigator David Erlinge, M.D., Ph.D., and head of the Cardiology Department at Lund University, Lund, Sweden. “ Each year millions of patients undergo PCI globally, and while a very safe procedure, the implantation of stents has been associated with an annual recurring adverse event rate. Sustained reduction and plateauing of these recurring adverse clinical events would create a major benefit over the lifetime of a patient.” Clinical results from the 2,400-patient INFINITY-SWEDEHEART study demonstrated: TLF of 2.35% versus 2.77% met non-inferiority (p<0.001) at 12 months for DynamX bioadaptor and Resolute Onyx DES, respectively. The low TLF with DynamX was driven by numerically low adverse events across components of the composite endpoint with DynamX compared to Resolute Onyx DES, respectively: Target vessel myocardial infarction (TV-MI) (1.27% versus 1.52%) Ischemia-driven target lesion revascularization (ID-TLR) (1.27% versus 2.11%) Cardiovascular death (0.59% versus 0.50%) Target vessel failure (TVF) at 12 months was also lower at 3.03% versus 3.52%, for DynamX compared to DES, respectively. Landmark analysis 1 : Pre-specified landmark analyses of TLF and TVF after six months demonstrated: Statistically significant reduction in TLF with DynamX (0.2% versus 1.3%, p=0.003) Statistically significant reduction in TVF with DynamX (0.6% versus 1.8%, p=0.008) These event rates were driven by reduction across all components of these composite endpoints “ The results of our trial strongly support the clinical impact of the Bioadaptor in coronary artery disease treatment, with a potential to significantly reduce the recurring adverse event risk after percutaneous coronary intervention in a population representative of everyday clinical practice,” said study chair Stefan James, M.D., Ph.D., and Professor of Cardiology at Uppsala University, Sweden. “ The Bioadaptor technology has proven to be able to do this through its unique design and mechanism of action of restoring hemodynamic modulation of a diseased artery. The DynamX bioadaptor was recently granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for an indication to improve coronary luminal diameter, restore hemodynamic modulation, and reduce plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The bioadaptor has a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore more normal vessel biology. Locked phase: The bioadaptor establishes maximum flow lumen to restore blood flow. Unlocked/Separation phase: Unique to the bioadaptor, after six months, helical strands unlock and separate to allow adaptive remodeling of the vessel to maintain the established blood flow lumen. Adaptive dynamic support phase: The three—now independent—helical strands continue to provide essential support as the bioadaptor re-establishes vessel hemodynamic modulation through restoration of pulsatility, compliance and adaptive blood flow volume. “ Results from the INFINITY-SWEDEHEART trial validate in a broad, more clinically complex patient population what we’ve shown previously in BIOADAPTOR RCT and several mechanistic and investigator-initiated studies – consistency of low and plateauing adverse event rates after the unlocking of the bioadaptor at six months,” said Motasim Sirhan, CEO of Elixir Medical. “ We are thrilled by the results from the landmark analysis data after six months showing statistically significant reduction in TLF and TVF versus DES. As an innovation-driven company, these data further validate the bioadaptor’s unique mechanism of action and its advantage in treating coronary artery disease to improve the standard of care for our patients.” About the INFINITY-SWEDEHEART Trial The INFINITY-SWEDEHEART Trial is a prospective, multi-center, single-blind, randomized (1:1), registry-based clinical trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 2,400 patients. The trial is executed in partnership with the ongoing SWEDEHEART registry program in Sweden, a national collaborative research program launched in 2009 to support the evidence-based development of therapies for heart disease. Study management is conducted in collaboration with Uppsala Clinical Research Center (UCR), a non-profit organization providing clinical research services for the development and improvement of health care in Sweden and worldwide. DynamX Coronary Bioadaptor System The DynamX bioadaptor is designated by the FDA as a breakthrough technology and is the first coronary implant designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, adaptive increase in blood flow volume, and to provide plaque stabilization and regression. With this unique mechanism of action (MOA), the bioadaptor addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds translating to remarkably low clinical event rates that plateau after six months as demonstrated in two randomized controlled trials, BIOADAPTOR-RCT (N=445) and INFINITY-SWEDEHEART (N=2,400). The DynamX Coronary Bioadaptor System is CE-marked. Not available for sale in the U.S. About Elixir Medical Elixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at www.elixirmedical.com and on LinkedIn and X . Reference: 1 Erlinge, D., Andersson, J., Fröbert, O., Törnerud, M., Böhm, F., Held, C., Elek, C., Sirhan, M., Oldgren, J., & James, S. (2024). Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent. American Heart Journal, 277, 1-10. https://doi.org/10.1016/j.ahj.2024.07.016

August 30, 2024 Biodexa Pharmaceuticals PLC(“Biodexa” or the “Company”)Receipt of Nasdaq Delisting Determination Plans to Appeal 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, announced today that on August 27, 2024, it received a Staff Determination letter (the “Letter”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company of the Staff’s determination to delist the Company’s securities from The Nasdaq Capital Market because the Company’s securities have had a closing bid price below $1.00 for 30 consecutive business days, which triggers a notice of delisting pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Rule”). Normally, a company would be afforded a 180-calendar day period to demonstrate compliance with the Rule. However, pursuant to Listing Rule 5810(c)(3)(A)(iv), the Company is not eligible for any compliance period specified in Rule 5810(c)(3)(A) because the Company effected reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one. Accordingly, and as described in the Letter, unless the Company timely requests a hearing before a Hearings Panel (the “Panel”), the Company’s securities would be subject to suspension/delisting. Accordingly, the Company intends to timely request a hearing before the Panel. The hearing request will automatically stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. 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 Blader 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 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 signaling 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 including, but not limited to, the anticipated net proceeds, and the anticipated use of proceeds therefrom, and projected cash runway. 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.