drugset / Press release

Nyrada Successfully Completes Cardioprotection Pilot Study

2026-06-03 · Nyrada Pty Ltd · original nyrada.com ↗

Page 1 Nyrada Inc. Level 22/23, Salesforce Tower, 180 George Street, Sydney NSW 2000 ARBN 625 401 818 3 June 2026 Sydney, Australia Nyrada Successfully Completes Cardioprotection Pilot Study Highlights: • Nyrada has successfully completed a pilot preclinical study evaluating repeated subcutaneous dosing of its lead drug candidate Xolatryp® in combination with doxorubicin. • Preliminary biomarker data showed numerically lower mean cardiac troponin I, a clinically relevant marker of cardiac injury, in the 12 mg/kg/day and 36 mg/kg/day treatment groups relative to the doxorubicin plus vehicle control group. • The study confirmed the feasibility and tolerability of the intended subcutaneous dosing regimen and will inform dose selection for Nyrada’s larger cardiomyopathy (cardioprotection) study. Nyrada Inc (ASX:NYR) , a clinical -stage biotechnology company focused on developing Transient Receptor Potential Canonical (TRPC) ion channel inhibitors to treat a range of medical conditions, today provides results of a pilot preclinical cardioprotection study. Background and Anthracycline Induced Cardiotoxicity Following from Nyrada’s assessment of Xolatryp as an adjunct in anthracycline -treated cancers, the Company initiated a further pilot study to guide the design of its larger cardiomyopathy (cardioprotection) study. Anthracycline drugs have a long -established role in the oncology; however, their clinical use can be limited by cumulative, dose -dependent cardiac injury. There remains a recognised need for therapies that may reduce this cardiotoxicity without compromising anti -tumour activity. The objective of Nyrada’s work is to evaluate wheth er Xolatryp may have a cardioprotective role in the setting of anthracycline chemotherapy. Study Design and Key Outcomes The pilot study was designed to assess the feasibility and tolerability of repeated subcutaneous Xolatryp dosing in combination with doxorubicin, and to inform dose selection for subsequent efficacy studies. This pilot study was not designed or powered to demonstrate statistical significance for an efficacy readout. Mice received doxorubicin at 5 mg/kg intravenously once weekly for two weeks, together with Xolatryp administered subcutaneously four times daily for three consecutive days at 12 mg/kg/day and 36 mg/kg/day. Page 2 Nyrada Inc. Level 22/23, Salesforce Tower, 180 George Street, Sydney NSW 2000 ARBN 625 401 818 The planned dosing regimen was completed as designed, supporting the feasibility of repeated subcutaneous administration in preclinical studies to achieve sustained systemic exposure relevant to the intended clinical intravenous dosing paradigm. Xolatryp was generally well tolerated across all dose levels evaluated, with no unexpected safety observations during the study. Cardiac troponin I (cTnI) was measured at study completion. Results Preliminary biomarker findings demonstrated numerically lower mean cTnI levels in the 12 mg/kg/day and 36 mg/kg/day Xolatryp treatment groups compared with the doxorubicin plus vehicle control group (Figure 1). These findings provide initial evidence supporting further investigation of Xolatryp's potential cardioprotective activity in the setting of anthracycline chemotherapy. Vehicle control Doxorubicin (5 mg/kg) + Vehicle Doxorubicin + Xolatryp (12 mg/kg/day) Doxorubicin + Xolatryp (36 mg/kg/day) 0 10 20 30 40 Plasma Cardiac Troponin I following Treatment with Doxorubicin and Xolatryp pg/mL Figure 1. Plasma cardiac troponin I (cTnI) concentrations following doxorubicin administration and treatment with Xolatryp. Mean plasma cTnI levels (± SEM) (n = 3 per group) measured at the end of a two-week pilot study evaluating the feasibility of repeated subcutaneous Xolatryp dosing in combination with doxorubicin. Page 3 Nyrada Inc. Level 22/23, Salesforce Tower, 180 George Street, Sydney NSW 2000 ARBN 625 401 818 No significant or dose -dependent alterations were seen in body weight or liver enzymes, indicating that the combination drug therapy was well-tolerated. Conclusion and Next Steps The results of this pilot study will be used to finalise the design of Nyrada’s larger and adequately powered cardiomyopathy study. This larger study is intended to evaluate approximately 12 animals per group over a five -week treatment period using clinically relevant doxorubicin exposure, with comprehensive cardiac assessments including biomarkers, cardiac function and histopathology. The study is designed to further define the dose -response relationship and to evaluate the potential of Xolatryp to mitigate anthracycline -induced cardiac injury. While dosing in the cardiomyopathy study will be subcutaneous, this is a proxy for intravenous dosing in a clinical setting. It is expected that the results for this study will be available in 3Q CY2026. About Xolatryp Xolatryp is a small-molecule inhibitor of TRPC3/6/7 channels designed to limit excessive Ca²⁺ entry related to multiple disease pathologies. A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics has been successfully completed and a Phase IIa clinical trial has commenced to assess the safety and preliminary efficacy of Xolatryp in reducing cardiac reperfusion injury in patients with ST-Elevation Myocardial Infarction (STEMI) undergoing PCI. – ENDs – Page 4 Nyrada Inc. Level 22/23, Salesforce Tower, 180 George Street, Sydney NSW 2000 ARBN 625 401 818 About Nyrada Inc. Nyrada Inc. is a clinical -stage biotechnology company focused on the discovery and development of innovative small -molecule therapies, specifically targeting Transient Receptor Potential Canonical (TRPC) ion channels. The company’s lead candidate, Xolatryp®, has shown efficacy in preclinical cardioprotection, neuroprotection, and oncology models and has completed a first-in-human Phase I clinical trial. A Phase IIa clinical trial has commenced to assess the safety and preliminary efficacy of Xolatryp in reducing cardiac reperfusion injury in patients with ST -Elevation Myocardial Infarction (STEMI) undergoing PCI . Nyrada Inc. (ARBN 625 401 818) is incorporated in Delaware, US, with limited liability for its stockholders. www.nyrada.com Authorised by James Bonnar, Managing Director and CEO, on behalf of the Board. Investor & Media Enquiries: Company Secretary: Dimitri Burshtein David Franks T: 0491 789 391 T: 02 8072 1400 E: [email protected] E: [email protected] Page 5 Nyrada Inc. Level 22/23, Salesforce Tower, 180 George Street, Sydney NSW 2000 ARBN 625 401 818 Forward-Looking Statements This announcement may contain forward -looking statements. You can identify these statements by the fact they use words such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project ”, “plan”, “should”, “target”, “will” or “would” or the negative of such terms or other similar expressions. Forward -looking statements are based on estimates, projections, and assumptions made by Nyrada about circumstances and events that have not yet taken place. Although Nyrada believes the forward -looking statements to be reasonable, they are not certain. Forward -looking statements involve known and unknown risks, uncertainties and other factors that are in some cases beyond the Company’s control (including but not limited to the COVID-19 pandemic) that could cause the actual results, performance, or achievements to differ materially from those expressed or implied by the forward-looking statement.

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