Nyrada Inc - Annual Report 2023

NYRADA INC (ASX:NYR) 10 CEO Report Dear Fellow Shareholders, It is my pleasure again to provide to you with this update on Nyrada’s results and operations for the 2023 financial year. I wish to thank all shareholders for your ongoing support. Our drug development programs remain focused on areas of substantial unmet clinical need where few if any, effective or well-tolerated therapies exist. The Nyrada team and I are firmly committed to our strategy and success of the Company. Every day we work and strive to find solutions to important health issues for patients that are underserved by existing treatments available. Through this patient focus, we also aim to create value for our investors and broader stakeholders. This is the strategic foundation upon which our Cholesterol Lowering and Brain Injury programs sit, with the work put in during the 2023 year setting us up for a stronger 2024. The target markets for these programs are significant and growing. Cholesterol Lowering Program 2023 was a very active year for the Company’s cholesterol lowering program. All necessary formulation work, toxicology, safety, and pharmacology studies were undertaken for NYX-1492 (PCSK9i), the Company’s cholesterol-lowering PCSK9 inhibitor drug candidate. Early into the 28-day in vivo Good Laboratory Practice (GLP) toxicology study, the Company was encouraged by preliminary results. However, late in June 2023, the Company was advised of an adverse signal in one of the 11 required studies. This finding occurred in a small number of animals which were otherwise healthy and was only detected following microscopic analysis. Consequently, it was concluded that NYX-1492 will not be advanced into clinical development for cholesterol management. Such setbacks, whilst unfortunate and frustrating, are ultimately a normal part of the scientific discovery process. The Company is currently screening alternative PCSK9 inhibitor candidates that preclude the identified toxicity issue and are structurally differentiated from NYX-1492. Nyrada remains committed to developing an oral small molecule PCSK9 inhibitor drug. The market opportunity is significant and underserved with current injectable treatments that are both expensive and inconvenient. Accelerated by demographic, lifestyle, and dietary changes, the market size for statins, the most common current treatment for cholesterol lowering reached US$14.9 billion in 20221 and is expected to reach US$22.2 billion by 20302. Brain Injury Program Our brain injury program continues to show great promise. The market size for secondary brain injury treatments is difficult to accurately quantify because there are no products available. Nyrada’s candidate drug is a novel treatment and pioneering in this sense. However, it is estimated that some 2.8 million persons in the US experience sport and recreation related traumatic brain injury (TBI) annually, while globally 15 million people suffer a stroke every year. The opportunities to reduce the long-term consequences of stroke or TBI are significant. “This is the strategic foundation upon which our Cholesterol Lowering and Brain Injury programs sit, with the work put in during the 2023 year setting us up for a stronger 2024. The target markets for these programs are significant and growing.” 1. https://www.imarcgroup.com/statin-market#:~:text=Market%20Overview%3A,3.2%25%20during%202023%2D2028. 2. https://www.databridgemarketresearch.com/reports/global-statin-market

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