ANNUAL REPORT FY2024 19 Preclinical Traumatic Brain Injury Study Later in the financial year, Nyrada commenced a collaborative TBI study with its collaborative partners, the Walter Reed Army Institute of Research (WRAIR) and UNSW. This study evaluates the efficacy of NYR-BI03 in a rodent model of penetrating TBI, a proprietary model of WRAIR that simulates serious head injuries sustained by military service members. The study assesses the neuroprotective effects of NYR-BI03 following a penetrating TBI. Preclinical Safety Study Nyrada began Good Laboratory Practice (GLP) studies to assess the safety of NYR-BI03 in two animal species. Successful completion of these GLP studies is required before initiating a first-in-human Phase I clinical trial, scheduled for the quarter ending December 2024. In July 2024, Nyrada reported on the first tranche of GLP studies, demonstrating NYR-BI03's safety in two in vitro tests: • AMES (Bacterial Reverse Mutation) Test: Evaluated the mutagenicity and predicted genetic risks and potential carcinogenic effects of NYR-BI03. • hERG (Human Ether-a-go-go-related Gene) Test: Assessed the cardiovascular safety of NYR-BI03. The remaining GLP studies are ongoing and expected to be concluded soon, with results analysed and reported early in the quarter ending December 2024. Upon satisfactory completion of all GLP studies, Nyrada will submit a Human Research Ethics Application, aiming to commence the Phase I clinical trial in December 2024. Rebion Strategic Partnership In June, Nyrada was pleased to sign a Strategic Partnership Agreement with Boston-based medical device company Rebion, which uses Neural Performance Scanning technology to identify and monitor functional impairments in the brain stemming from disease or injury. This partnership focuses on advancing therapies and outcomes for TBI sufferers, including joint research, conference presentations, and applications for nondilutive funding grants. Cholesterol Lowering Program Early on in the 2024 financial year, Nyrada decided to not advance its cholesterol-lowering PCSK9 inhibitor drug NYX-1492 into clinical development following GLP study results. Low-cost background work continued throughout the year to explore development options for an effective and commercially viable PCSK9 inhibitor. These low-cost background works are ongoing. Nyrada continues to believe an oral small molecule PCSK9 inhibitor is an optimal approach for managing hypercholesterolemia, recognising its significant market potential. Financial summary Throughout the year, Nyrada maintained lean corporate operations, prioritising capital allocation towards research and development activities. Over 46% of net operating cash flow outflows were devoted to R&D. During the year, Nyrada raised a total of $1,965,000 equity capital (before costs), including $1,755,000 from new and existing professional and sophisticated investors, and $210,000 from board directors. In FY2024 the Company received a R&D tax incentive refund greater than the amount accrued by $2,232,325 for the period ending 30 June 2023, resulting in an increase in revenue. Consistent with prior years, the Company intends to lodge a claim under the Commonwealth Government’s Research and Development Tax Incentive scheme for research conducted in the 2024 financial year. It is estimated that Nyrada is eligible for a refund of $994,600, though the exact amount is uncertain. Any benefit received is expected in early the quarter ending December 2024.
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