Nyrada Inc - Annual Report 2021

Annual Report FY21 9 Brain Injury Program The Brain Injury Program has also been active in FY21. The team’s constant focus on optimising our compound to improve its drug-like characteristics has led to the development and selection of a new, more potent version of our brain injury candidate, called NYR-BI01, for our collaboration studies with WRAIR and UNSW. This new compound has improved solubility and tissue protein-binding properties while maintaining its potency in blocking calcium ion build-up in cells. This build-up of calcium ions would otherwise activate cell-death pathways and inflammation in the brain following brain injury. NYR-BI01 is also able to cross the blood-brain barrier at above therapeutic levels, meaning it can reach the area of the brain damaged by secondary brain injury (excitotoxicity). The development of this new, highly potent compound follows studies last year in which Nyrada achieved durable therapeutic levels of two compounds in the brain. Both were safe and well-tolerated with continuous intravenous infusion, the preferred route for patients suffering from moderate-severe traumatic brain injury and stroke. “The team has made significant progress in both our key drug development programs for Cholesterol- Lowering and Brain Injury, resulting in encouraging preclinical data that positions us well for completing the remaining safety and toxicology studies before we commence Phase I trials.” The team is now focused on completing the pilot work necessary before commencing the evaluation of NYR-BI01 in conjunction with WRAIR and UNSW in the third quarter of 2021. Nyrada expects the initial results of the collaboration studies to be reported before the end of the calendar year. We anticipate commencing the first-in-human Phase I study in the second half of calendar year 2022. Our successes and good progress have been the result of a great deal of hard work from our talented team and I’d like to thank them for their continued commitment. Despite the ongoing challenges presented by the COVID-19 pandemic, the team continues to work effectively to advance our Programs and there has been minimal disruption to operations at our key vendors. Nyrada’s outlook is extremely positive, with new studies starting and a strong pipeline of results ahead. On behalf of the team, I want to offer everyone our best wishes and thank you for your ongoing support. Yours sincerely, James Bonnar CEO Nyrada, Inc