ANNUAL REPORT FY23 17 Financial results The loss for the Consolidated Entity after providing for income tax amounted to $7,781,692 (30 June 2022: $3,959,661). The year ended 30 June 2023 operating results included the following: • Research and Development Tax Incentive refund of $1,309,407 relating to the accrued FY2023 refund (2022: $1,048,333 relating to the accrued FY2022 refund). • Research and development costs of $6,411,264 (FY2022: $1,835,072); • Corporate and administration expenses of $641,117 (FY2022: $699,653); • Share based payment expense of $541,214 (FY2022: $966,951); • Professional services expense of $409,523 (FY2022: $338,841); and • Employee benefits expense of $1,100,136 (FY2022: $1,000,030) The cash position as at 30 June 2023 was $3,708,761 (30 June 2022: $10,816,039). Review of operations During the financial year concluded 30 June 2023, Nyrada continued to advance its two lead drug development programs: • Cholesterol Lowering Program - an oral PCSK9 inhibitor drug for the management of high blood LDL-cholesterol levels in patients at risk of cardiovascular disease, where statin drugs are poorly tolerated or ineffective; and • Brain Injury Program - a TRPC channel blocking neuroprotectant drug to reduce the impact of secondary brain injury in patients following a stroke or traumatic brain injury, a sudden and external shock which can disrupt the normal functioning of the brain. Cholesterol Lowering Program Preclinical Studies During the 2023 financial year, Nyrada undertook Good Laboratory Practice (GLP) safety and toxicology studies of its cholesterol lowering PCSK9 inhibitor drug NYX-1492 (PCSK9i). These studies are required by regulators to assess the safety and tolerability of drug candidate prior to commencing in-human clinical trials. In late June 2023, however, the Company received news of an adverse signal in one of the 11 mandatory GLP safety and toxicology studies. The finding occurred in a small number of animals which were otherwise healthy and were only detected following microscopic analysis. Following consultation with the Contract Research Organisation (CRO) that performed the GLP studies, and a subsequent review by the Company’s Scientific Advisory Board (SAB), it was concluded that NYX-1492 will not be advanced into clinical development for cholesterol management. Nyrada has maintained its commitment to developing an oral small molecule PCSK9 inhibitor drug, developing a plan to assess alternative candidates that are structurally differentiated from NYX-1492. As part of this process, alternative candidates will be screened with a view to preclude the identified toxicity issue. No costs for the now deferred Phase I/IIa clinical trial were incurred. Brain Injury Program Preclinical Studies During the 2023 financial year, GLP studies on NYR-BI02 were undertaken. These studies showed that NYR-BI02 was a potent blocker of canonical transient receptor potential (TRPC) ion channels, limiting excitotoxicity and secondary brain damage following a traumatic brain injury (TBI) or stroke. However, NYR-BI02 demonstrated a sub-optimal safety profile for continuous dosing in patients with these conditions. Following review, NYR-BI03, a closely related analogue of NYR-BI02, was identified as having a superior safety profile for continuous intravenous dosing. This, coupled with superior potency on TRPC ion channel target, led to NYR-BI03’s selection as Nyrada’s new lead brain injury drug candidate. NYR-BI03 will also be the agent used for preclinical efficacy testing in the Walter Reed Army Institute of Research (WRAIR) TBI model, and separately in a CRO strokemodel. The strokemodel will be used to study the efficacy of NYR-BI03 in blocking three key channels (TRPC 3,6,7).
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