ANNUAL REPORT FY2025 7 CEO Report Dear Fellow CDI Holders, It is with great enthusiasm that I present this update on Nyrada’s progress over the 2025 financial year. This period has marked a transformative phase for the Company as we progressed from a discovery-stage biotech to a clinical-stage innovator. Our lead drug candidate, Xolatryp™ (formerly NYR-BI03), has made tremendous strides, and our achievements underscore a firm commitment to addressing critical unmet needs in both cardioprotection and neuroprotection. Just twelve months ago, we were concluding our preclinical safety studies. Today, I am pleased to report that Xolatryp has successfully completed its first-in-human Phase I clinical trial and is now positioned to enter Phase IIa development in the treatment of acute myocardial infarction (AMI). Xolatryp is a first-in-class small molecule inhibitor targeting TRPC3/6/7 ion channels—proteins that regulate calcium influx and play a central role in the pathophysiology of ischemic and mechanical injury to the heart and brain. Overactivation of these channels leads to calcium overload, cellular dysfunction, and ultimately cell death. By blocking this cascade, Xolatryp has demonstrated robust preclinical efficacy in models of stroke, traumatic brain injury (TBI), and ischemia-reperfusion injury. The Phase I trial, conducted at Scientia Clinical Research with the support of Southern Star Research, was designed to assess the safety, tolerability, and pharmacokinetics of Xolatryp in healthy volunteers. Following Human Research Ethics Committee (HREC) approval in February 2025, the study proceeded methodically through six cohorts. By 30 June, four cohorts had been completed, with the fifth and sixth reporting shortly after the end of the financial year. Importantly, the study encountered no dose-limiting toxicities, safety concerns, or unexpected adverse events. A notable development during the trial was the approval of an amended protocol, which enabled the exploration of higher doses and extended infusion durations. This flexibility enhances our ability to tailor the design of future Phase II studies and allows for a broader evaluation of Xolatryp's potential. Final data from the Phase I study is on track to be completed in the first quarter of FY2026. In October 2024, we reported the outcome of a preclinical study on acute myocardial injury, in which Xolatryp delivered an 86 percent cardioprotective benefit when Xolatryp is dosed over a 24-hour continuous infusion. A subsequent study in May 2025 further supported these findings, revealing that a three-hour continuous infusion resulted in a 42 percent reduction in cardiac injury. “I am pleased to report that Xolatryp™ has successfully completed its first-inhuman Phase I clinical trial and is now positioned to enter Phase IIa development in the treatment of acute myocardial infarction”
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