Nyrada Inc - Annual Report 2021

Annual Report FY21 17 Developing a drug to block secondary brain damage following a stroke or traumatic brain injury Nyrada’s Brain Injury Program saw significant progress with its neuroprotectant drug designed to limit secondary brain injury. This area of research is attracting significant international industry attention. Nyrada’s Brain Injury Program data was selected for publication in an abstract at the US Military Health System Research Symposium in July 2020. This event is the US Department of Defense’s foremost scientific meeting for presenting new scientific knowledge resulting from military research and development. Also in July 2020, Nyrada’s preclinical pharmacokinetics study saw its brain injury drug candidates successfully delivered by continuous intravenous injection. Both candidates reached and maintained effective therapeutic levels in the brain, resulting in the desired pharmacokinetic profiles for clinical studies. Continuous intravenous injection is the preferred administration route for patients who suffer a stroke or sustain a moderate or severe TBI. In addition, Nyrada performed a pilot study evaluating the intranasal route of delivery for its drug candidates. This is the preferred route of treatment for patients with mild TBI and concussion injury, which is common in sports. Aligned with Nyrada’s business model to collaborate and partner early, the Company achieved a key milestone announcing a new collaboration with the Walter Reed Army Institute of Research (WRAIR) and the University of New South Wales, Sydney (UNSW). The collaboration studies aim to examine the efficacy of a lead preclinical neuroprotection compound to interrupt and minimise the excitotoxicity process responsible for secondary damage to the brain in TBI, which can lead to a doubling of the injury size in the days following a TBI event. Most recently in June 2021, Nyrada selected a new, more potent analogue of its brain injury candidate, called NYR-BI01, to be taken forward into the studies with WRAIR and UNSW. NYR-BI01 showed improved potency, along with excellent pharmacokinetic properties and blood-brain barrier penetration. Drug levels in the brain were significantly higher than those required to deliver a therapeutic effect and NYR-BI01 was well-tolerated throughout the 72-hour study. Importantly, the study duration aligns with the therapeutic window for preventing secondary brain injury in patients. Together with WRAIR and UNSW, pilot work has commenced to determine the baseline injury signal in TBI animal models that are expected to be used in the studies. The animal models are highly specialised and mimic moderate to severe injury in humans. The injury is measured using multiple MRI techniques, which are commonly used in the clinical setting to assess injury localisation and volume in patients. Following this pilot work, Nyrada anticipates testing of NYR-BI01 in the TBI models at WRAIR will commence in the third quarter of 2021, with the initial results expected before the end of the year. The Company anticipates commencing the first-in-human Phase I study in the second half of CY2022. Intellectual Property After the reporting period, in July 2021, Nyrada was granted its first patent for the Cholesterol Lowering Program’s PCSK9i inhibitor by the United States Patent and Trademark Office (USPTO). The composition of matter patent protects Nyrada’s intellectual property (IP) around its PCSK9 inhibitor technology in the US and marks an important achievement in its active IP strategy. The patent number is 11091466 and its expiry date is 16 March 2038. Capital Raise Following encouraging preclinical results from both programs, Nyrada raised $11.5 million via a two-tranche Placement, with strong demand from existing and new investors. The issue of stock in tranche two was approved at the Company’s June 2021 Extraordinary General Meeting. Importantly, the proceeds will be used to fund the planned Phase I clinical trials for both the Cholesterol-Lowering and Brain Injury drug development programs, and enable further proof-of-concept studies to evaluate existing drug candidates in additional therapeutic areas to deliver shareholder value.