NYRADA INC (ASX:NYR) 14 Significant changes in the state of affairs There were no significant changes in the state of affairs of the Consolidated Entity during the financial year. Financial results The loss for the Consolidated Entity after providing for income tax amounted to $4,845,671 (30 June 2024: $1,391,309). The cash position as at 30 June 2025 was $2,930,601 (30 June 2024: $4,769,374). Review of operations Over the course of the 2025 financial year, Nyrada remained firmly focused on its mission as a biotechnology company dedicated to developing next-generation small-molecule therapies targeting Transient Receptor Potential Canonical (TRPC) ion channels. Central to this mission was the continued advancement of the Company’s lead candidate, Xolatryp™ (formerly NYR-BI03), which achieved significant progress across both clinical and preclinical programs, signalling a pivotal chapter in Nyrada’s growth. Clinically, FY2025 marked a major milestone with the commencement of Nyrada’s first-in-human Phase I trial of Xolatryp, a first-in-class compound aimed at treating acute neurological and cardiovascular conditions. Conducted at Scientia Clinical Research and supported by Southern Star Research, the trial was designed to evaluate the safety, tolerability, and pharmacokinetics of Xolatryp in healthy volunteers. By 30 June, four of the six cohorts had reported, with the fifth cohort reporting shortly after the end of the financial year. Importantly, the trial proceeded without any dose-limiting toxicities, safety concerns, or unexpected adverse events. A key development during the year was the Human Research Ethics Committee’s approval of an amended trial protocol, allowing for the investigation of higher doses and an extended infusion duration. This amendment enhances the Company’s flexibility in shaping the design of future Phase II studies. Final data from the Phase I study remains on track for release in the first quarter of FY2026. Progress in preclinical research further reinforced the potential of Xolatryp. In April 2025, the Company announced the results of a study conducted in collaboration with the Walter Reed Army Institute of Research (WRAIR) and UNSW Sydney, assessing Xolatryp in a rodent model simulating penetrating traumatic brain injury (TBI), similar to those experienced by military personnel. The findings showed statistically significant neuroprotection, confirmed through blinded high-resolution MRI analysis. These results build on earlier rodent studies in which Xolatryp preserved 42% of brain tissue in the penumbra following an ischemic stroke. In addition to its neurological applications, Xolatryp also demonstrated powerful cardioprotective effects. In October 2024, Nyrada reported the outcome of a preclinical study in acute coronary injury, where Xolatryp provided an 86% cardioprotective benefit following myocardial ischemia-reperfusion. Subsequent echocardiography confirmed marked improvements in both cardiac structure and function. These findings were strengthened by a follow-up study announced in May 2025, which showed that a three-hour continuous administration of Xolatryp led to a 42% cardioprotective effect. Notably, the treatment significantly reduced biomarkers of cardiac injury and lowered the incidence of dangerous arrhythmias such as ventricular fibrillation and tachycardia—two of the leading causes of sudden cardiac death. Collectively, these outcomes highlight Xolatryp as a versatile therapeutic with promise in treating conditions where no FDA- approved treatments currently exist. With compelling preclinical evidence now established across ischemic stroke, TBI, and cardiac ischemiareperfusion injury models, Nyrada repositioned the compound under its new name, Xolatryp, to better align with its long-term clinical and commercial aspirations. The Company filed a trademark application for the new name and lodged a provisional patent covering the drug’s chemical structure. An international patent search later confirmed the novelty and inventiveness of Xolatryp, strengthening the Company’s intellectual property position and its leadership in TRPC-targeted drug development.
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