TRx Biosciences Limited

DESyne BDS Plus system with site-specific antithrombotic therapeutic (TRx) significantly reduced the risk of TLF versus conventional drug-eluting stent through 12-months First site-specific antithrombotic therapeutic with two anticoagulants and an anti-proliferative mTOR inhibitor designed to reduce the burden of managing ischemic and thrombotic risk in cardiovascular interventions PARIS--(BUSINESS WIRE)-- Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced significant positive 12-month clinical data from the DESyne BDS Plus Randomized Controlled Trial (RCT) evaluating DESyne BDS Plus, the world’s first triple drug-eluting coronary implant with site-specific antithrombotic therapeutic (TRx) coating versus a contemporary, durable polymer drug-eluting stent (DES). The data demonstrated a statistically significant lower TLF rate with DESyne BDS Plus than contemporary DES. The data were presented at a late-breaking clinical session during the EuroPCR 2024 conference in Paris. “The current standard of care of combining oral antithrombotic therapies continues to pose serious challenges, especially in patients who are at high thrombotic risk and high bleeding risk, as managing the tradeoff between ischemic and bleeding risks is logistically unsustainable for healthcare providers and often results in delay of essential treatment decisions,” said Alexandre Abizaid, M.D., Ph.D., interventional cardiologist at Instituto do Coração (InCor) in Sao Paulo, Brazil. “These exciting results from the DESyne BDS Plus RCT demonstrate the sustained superiority in safety and efficacy of DESyne BDS Plus compared to a standard of care DES and underscore the potential for site-specific anti-thrombotic therapeutic (TRx) as a promising solution that effectively addresses the compromises we have to make between bleeding and thrombosis when using systemic drug therapies.” 12-month clinical results demonstrated safety and efficacy of DESyne BDS Plus: Significantly lower TLF rate of 2.1% for DESyne BDS Plus compared to 9.3% for contemporary DES, p=0.03. No definite or probable stent thrombosis, cardiovascular death, or target vessel myocardial infarction (TV-MI), were observed in DESyne BDS Plus treated patients Previously presented data found that the study’s primary endpoint was met (pnon-inferiority<0.001); TLF at day three or at hospital discharge, whichever came first, which was 0.0% for DESyne BDS Plus treated patients versus 5.0% for patients treated with the contemporary durable polymer DES. DESyne BDS Plus has a bioresorbable coating containing three drugs: two anticoagulants (rivaroxaban and argatroban) and an antiproliferative mTOR inhibitor (sirolimus) designed for delivery of site-specific antithrombotic therapeutic. The coronary implant with TRx therapeutic is designed to reduce thrombotic risk while eliminating the negative side effect of bleeding associated with oral anti-thrombotic use and to effectively help address the challenge of logistically managing ischemic and bleeding risk in at-risk PCI patient populations. “We are thrilled with the statistically significant 12-month clinical outcomes of the TRx platform validating the improved safety and effectiveness of site-specific TRx therapeutic for coronary PCI treatment,” said Motasim Sirhan, CEO of Elixir Medical. “Site-specific antithrombotic therapy can be a more effective approach to addressing ischemic risk without the risk and complications of bleeding associated with oral anti-thrombotics.” Coronary artery disease is the leading cause of death for men and women in most racial and ethnic groups in the U.S.1 While PCI has positively impacted mortality rates,2 procedure and device related risks remain. Stent thrombosis after PCI is associated with large territory myocardial infarction (MI) events and poor outcomes, with death rates as high as 50% for early (<30 days) thrombosis cases.3 Management of ischemic and thrombotic risk requires medication adherence, but only 60% of patients are adherent to their prescribed cardiovascular medications which can lead to an increased risk of cardiovascular events or mortality by 20% or 35%, respectively.4 In addition, 3.5% of patients undergo non-cardiac surgery within six months of PCI procedure requiring careful management of thrombotic and bleeding risk by healthcare providers.5 About the DESyne BDS Trial The DESyne BDS Plus Randomized Clinical Trial (RCT) is a prospective, multicenter, single-blind study evaluating the safety, effectiveness, and performance of the DESyne BDS Plus Triple Drug-Eluting Coronary Implant compared to DESyne X2 Drug-Eluting Coronary Stent System in the treatment of de novo native coronary artery lesions. The trial includes 202 patients across 14 sites in Europe, New Zealand, and Brazil. An imaging subset of 58 patients had angiographic and optical coherence tomography (OCT) assessment completed in the first six months. Data collection will continue through three years. About TRx TRx is the world’s first triple-drug site-specific antithrombotic therapeutic using two anticoagulants (rivaroxaban and argatroban) and an antiproliferative mTOR inhibitor, sirolimus. The therapy was designed to address challenges associated with oral anti-thrombotics requiring a compromise between ischemic and bleeding risk, making it difficult and unsustainable for healthcare providers to manage patient needs. 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 technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at and on LinkedIn and X. References: Heart Disease Facts | CdC.gov. (2023, May 15). Centers for Disease Control and Prevention. Liza Chacko, James P. Howard, Christopher Rajkumar, Alexandra N. Nowbar, Christopher Kane, Dina Mahdi, Michael Foley, Matthew Shun-Shin, Graham Cole, Sayan Sen, Rasha Al-Lamee, Darrel P. Francis and Yousif Ahmad, Effects of Percutaneous Coronary Intervention on Death and Myocardial Infarction Stratified by Stable and Unstable Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials, Cardiovascular Quality and Outcomes. 2020 Lawton et al. 2021 ACC/AHA/SCAI Coronary Revascularization Guideline. Chen Chen, MD, 1 Xiaoqing Li, MD, 1 Yuhao Su, MD, 1 Zhigang You, MD, PhD, 1 Rong Wan, PhD, 2 and Kui Hong, MD, PhD. Adherence with cardiovascular medications and the outcomes in patients with coronary arterial disease: “Real‐world” evidence. Clinical Cardiology. September 18, 2022. Smilowitz et al. Risks of Non-Cardiac Surgery Early after Percutaneous Coronary Intervention. Am Heart J. 2019 November; 217: 64–71. View source version on businesswire.com: Contacts Emma Yang, Health+Commerce Email: emma@healthandcommerce.com Source: Elixir Medical Corporation View this news release online at:

Arecor Therapeutics plc(“Arecor” or the “Company”) ARECOR AND MEDTRONIC DIABETES ESTABLISH COLLABORATION TO DEVELOP A NOVEL THERMOSTABLE INSULIN FOR IMPLANTABLE PUMP DELIVERY Medtronic to fund Arecor’s development of Arestat™ enabled novel, high concentration, thermostable insulin, specifically tailored for use in combination with a next-generation implantable pump Cambridge, UK, 9 May 2024: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today’s therapies to enable healthier lives, today announced a research collaboration with Medtronic plc (NYSE: MDT), a global leader in healthcare technology, to develop a novel, high concentration, thermostable insulin for use by Medtronic’s Diabetes business in a next-generation implantable pump. This new insulin has the potential to bring significant advancements in the current insulin treatment options for a small population of patients who have limited options for controlling their diabetes with traditional therapy. This collaboration has the potential to allow for the continued care of these patients with an insulin that may minimise the need for pump maintenance interventions and expand the utility for physicians, whilst saving healthcare costs. Sarah Howell, Chief Executive Officer of Arecor, said: “Our leadership in this field has been demonstrated through our best-in-class ultra-rapid acting clinical development programmes (AT278 & AT247). Within the diabetes field more broadly we are seeing the rise of innovative delivery devices, including longer-wear and miniaturised pumps that are continually improving treatment options for patients. We are excited to play our part in this progress with the development of a highly differentiated insulin with the potential to transform treatment for an extremely vulnerable patient group. This collaboration is one of many we hope to enable, to further enhance the benefits of these next-generation devices.” Gary Dulak, Senior Director, New Venture Programs Medtronic Diabetes, said: “Medtronic Diabetes is a pioneer in implantable insulin pump systems for people living with type 1 diabetes, who are unable to tolerate conventional therapy that delivers insulin subcutaneously (under the skin). With intraperitoneal therapy via an implantable insulin pump system, insulin delivery is targeted for direct absorption by the liver via the implantable pump. We are pleased to collaborate with Arecor to explore new ways to develop this critical therapeutic option for the subset of individuals who may benefit from it.” This announcement contains inside information for the purposes of the retained UK version of the EU Market Abuse Regulation (EU) 596/2014 (“UK MAR”). Product not approved by the FDA for any use and not available for research or commercial use in the US. -ENDS- For more information, please contact: Arecor Therapeutics plcwww.arecor.comDr Sarah Howell, Chief Executive OfficerTel: +44 (0) 1223 426060Email: info@arecor.com Susan Lowther, Chief Financial OfficerTel: +44 (0) 1223 426060Email: info@arecor.com Panmure Gordon (UK) Limited (NOMAD and Broker) Freddy Crossley, Emma Earl (Corporate Finance)Rupert Dearden (Corporate Broking)Tel: +44 (0) 20 7886 2500 WG Partners LLP (Financial Advisor) Nigel Barnes, Satheesh NadarajahDavid Wilson, Claes SpangTel: +44 (0)203 705 9321 ICR Consilium Chris Gardner, David Daley, Lindsey NevilleTel: +44 (0) 20 3709 5700Email: arecor@consilium-comms.com Notes to Editors About Arecor Arecor Therapeutics plc is a globally focused biopharmaceutical company transforming patient care by bringing innovative medicines to market through the enhancement of existing therapeutic products. By applying our innovative proprietary technology platform, Arestat™, we are developing an internal portfolio of proprietary products in diabetes and other indications, as well as working with leading pharmaceutical and biotechnology companies to deliver therapeutic products. The Arestat™ platform is supported by an extensive patent portfolio. The collaboration adds to Arecor’s broad programme of diabetes focused activities, led by its two lead proprietary clinical development programmes – AT278 and AT247, two ultra-rapid acting insulin candidates that offer the potential to simplify and improve blood glucose control for people living with diabetes and could enable the development of next- generation miniaturised insulin delivery systems and a fully closed loop artificial pancreas system. In March 2024, Arecor established a research collaboration with TRx Biosciences for the formulation development of an oral glucagon-like peptide-1 (GLP-1) receptor agonist product that would provide a more convenient treatment option for patients with diabetes and obesity. The Group’s specialty pharmaceutical business, Tetris Pharma, commercialises Ogluo®, a glucagon prefilled autoinjector pen for patients living with diabetes suffering from severe hypoglycaemia. For further details please see our website, www.arecor.com