Nyrada Inc - Annual Report 2022

NYRADA INC (ASX:NYR) 16 Principal activities Nyrada is a preclinical stage, drug discovery and development company, specialising in novel small molecule drugs to treat cardiovascular and neurological diseases. The Company’s two lead programs are focused on Cholesterol-Lowering and Brain Injury, each targeting market sectors of significant size and unmet clinical need. These programs are developing an oral, small molecule Cholesterol-Lowering drug, and a drug to reduce secondary brain damage following a stroke or traumatic brain injury (TBI). Nyrada is a Company incorporated in the state of Delaware, US and is listed on the Australian Securities Exchange (ASX:NYR). 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 $3,959,661 (30 June 2021: $3,539,253). The year ended 30 June 2022 operating results included the following: • Research and Development Tax Incentive refund of $1,048,333 relating to the accrued FY2022 refund (2021: $2,286,022 relating to the FY2020/2021 refund of $1,309,650 and received FY2019/2020 refund of $976,372). • Research and development costs of $1,835,072 (FY2021: $2,175,050); • Corporate and administration expenses of $699,653 (FY2021: $895,839); • Share based payment expense of $966,951 (FY2021: $1,111,622); • Professional services expense of $338,841 (FY2021: $509,842); and • Employee benefits expense of $1,000,030 (FY2021: $929,931) The cash position as at 30 June 2022 was $10,816,039 (30 June 2021: $13,750,743). Review of operations During the 2022 financial year, Nyrada continued to advance its two lead drug development programs: • Cholesterol-Lowering Program: an oral PCSK9 inhibitor drug for the treatment of high blood LDL-cholesterol levels in patients at risk of cardiovascular disease, where statin drugs are poorly tolerated (monotherapy) or ineffective (single pill combination treatment). • Brain Injury Program: a neuroprotectant drug to reduce the impact of secondary brain injury in patients following a stroke or TBI, such as can occur following a motor vehicle accident, fall, or sporting injury. Strong results from both of these programs over the course of the year positions the Company well for the clinical studies ahead. Breaking new ground in the development of a once-per-day, oral cholesterol-lowering drug Nyrada’s oral PCSK9 inhibitor drug creates the potential for a next generation alternative to expensive and inconvenient PCSK9 injectable drugs. During FY2022, Nyrada’s Cholesterol-Lowering Program continued to deliver impressive preclinical results. In August 2021, exploratory analysis results from an in vivo cholesterol efficacy study showed NYX-PCSK9i significantly increased plasma PCSK9 levels, supporting the mechanism of action of Nyrada’s compound in lowering cholesterol. The 35-day study used a specialised mouse model genetically modified to better reflect the way in which humans metabolise cholesterol. NYX-PCSK9i was dosed at 50mg/kg as a monotherapy and in combination with the statin drug Lipitor® (atorvastatin, Pfizer) with no adverse effects identified. Treatment with NYX-PCSK9i also significantly increased the number of LDL receptors responsible for removing cholesterol from the bloodstream, with further analysis revealing Nyrada’s compound enhances cholesterol clearance from the body.