Nyrada Inc - Annual Report 2021

Annual Report FY21 5 Chairman’s Letter Dear Shareholders, It is with pleasure that I present Nyrada’s Annual Report for the financial year ended 30 June 2021, our first full year of operation as an ASX listed company, and one in which a great deal of progress has been made. Nyrada is a pharmaceutical company specialising in drug discovery and early-stage drug development. We focus on diseases with significant market size and considerable unmet patient need. Specifically, our drug candidates target cholesterol-lowering and brain injury prevention. Our strategy is to advance highly optimised drug candidates towards a key value inflection point, such as an efficacy signal, and out-license them early to large pharma, where the risk-reward equation is most favourable for Nyrada shareholders. Coupled with judicious capital allocation, this strategy facilitates a high growth model focused on maximising shareholder value. We have two core drug development programs that are both advancing well: our Cholesterol-Lowering Program and Brain Injury Program. Both Programs completed multiple preclinical studies during the year, culminating in the selection of optimised lead drug candidates to take forward into Phase I human trials. We are currently running the remaining necessary preclinical studies as we prepare to transition to a clinical-stage pharmaceutical company. The lead product candidate for our Cholesterol-Lowering Program is a PCSK9 inhibitor, called NYX-PCSK9i. It is designed to help patients with high LDL (“bad”) cholesterol achieve their target cholesterol levels. It has the potential to provide a convenient and cost-competitive oral therapy (in the form of a pill) for the 70% of patients at risk of cardiovascular disease who struggle to reach their target LDL cholesterol level despite taking a statin, such as Lipitor® (atorvastatin, Pfizer). Our aim is to help patients reduce their risk of cardiovascular disease (heart attack and stroke) which is responsible for 1-in-4 deaths in the US alone. At present, patients can augment their statin therapy with a monoclonal PCSK9 antibody drug, however, these are delivered by subcutaneous injection and are both inconvenient and expensive. We expect to commence a first-in-human Phase I clinical trial in Australia in mid-2022, to evaluate if NYX-PCSK9i lowers LDL cholesterol in healthy human volunteers. A positive efficacy signal from this study would form the basis of business development discussions with potential industry partners to out-license the drug. Nyrada’s Brain Injury Program is advancing a neuroprotectant drug, called NYR-BI01, to limit the secondary brain injury that occurs in the hours and days following a traumatic brain injury, concussion, or stroke, known as excitotoxicity. Each year in the US alone, 2.8million people suffer a traumatic brain injury and ~0.8 million suffer a stroke. “Our strategy is to advance highly optimised drug candidates towards a key value inflection point, such as an efficacy signal, and out-license them early to large pharma, where the risk-reward equation is most favourable for Nyrada shareholders. Coupled with judicious capital allocation, this strategy facilitates a high growth model focused on maximising shareholder value.”