Nyrada Inc - Annual Report 2022

NYRADA INC (ASX:NYR) 8 CEO Report Dear Fellow Shareholders, I am pleased to share our results and operating review for FY2022. The major operational challenge during the past 12 months has been the COVID-19 pandemic which has continued to disrupt global supply chains and logistics. While Nyrada’s drug manufacturing timelines were temporarily impacted by COVID-related lockdowns in Shanghai, China, delays were minimised because of the exceptional efforts of employees at the Contract Manufacturing Organisation (CMO) engaged by Nyrada, who worked tirelessly to recover time lost during the lockdown. Notwithstanding, we have continued to deliver promising preclinical results in both our Cholesterol-Lowering and Brain Injury Programs. In the Cholesterol-Lowering program, exploratory analysis conducted as part of a successful in vivo cholesterol efficacy study of drug candidate NYX-PCSK9i, delivered encouraging results that further support its mechanism of action in lowering cholesterol. Furthermore, in a novel human tissue-engineered model of atherosclerosis developed by researchers at Duke University, an optimised analogue of NYX-PCSK9i was shown to block the early phases of atherosclerosis, which is the chronic inflammatory response to elevated LDL-cholesterol leading to a build-up of plaque in the inner lining of the arteries. This analogue also exhibited superior pharmacokinetic parameters (improved absorption and distribution) in the study and accordingly, will be evaluated in Nyrada’s Phase I study in the first half of CY2023. The results of the atherosclerotic study are an exciting development in understanding the broader applications for PCSK9 inhibitors beyond lowering LDL-cholesterol, particularly as atherosclerotic plaque build-up is a major cause of cardiovascular disease. Additionally, there continues to be encouraging industry interest globally in the development of oral PCSK9 inhibitors, which clinicians consider to be an optimal approach to LDL-cholesterol lowering as an adjunct to statin treatment. Moreover, Nyrada’s lead brain injury drug candidate, NYR-BI02, a TRPC channel blocker, showed excellent oral bioavailability in an exploratory study, demonstrating it could potentially be administered as an oral treatment for concussion, in addition to intravenous dosing for severe traumatic brain injury (TBI) and stroke. The convenience of an oral dose form that can be administered in the field immediately after a concussion injury, without having to wait for hospitalisation, has the potential to significantly improve patient recovery outcomes. Given the significant interest in this area, these results open the door for the Company to potentially develop NYR-BI02 as an oral treatment for concussion as an additional program. Collectively, these results speak to the quality of the assets that the Nyrada team is developing, and their potential to positively impact patient lives as both programs advance towards the clinic. We are also encouraged by recent published preclinical research that highlights emerging opportunities in chronic heart and kidney disease indications for an orally bioavailable drug targeting TRPC 3/6/7 channels. Nyrada is reviewing these opportunities and considering next steps. “With the incidence of TBI increasing globally, this remains a large market with a significant unmet clinical need. Through our relationships with the world-class leading research teams at the Walter Reed Army Institute of Research (WRAIR) and UNSW Sydney (UNSW), Nyrada is in a unique position to develop the first drug to treat both TBI and stroke, with the potential to make a tangible difference in the quality of life of people affected by these injuries.”