Nyrada Inc - Annual Report 2022

NYRADA INC (ASX:NYR) 10 As part of its active intellectual property protection program, Nyrada has filed a provisional patent covering a library of molecules, including NYR-BI02, that block these TRPC channels. It is anticipated that the patent will have coverage in the US, Australia, and Europe. Outside of our collaboration with WRAIR, we are also evaluating the efficacy of our brain injury drug candidate in a well-established preclinical stroke model, the Photothrombotic Model of Ischemia, with results expected in the fourth quarter. This model was previously used by Nyrada to test the efficacy of its first-generation molecule, which showed a promising efficacy signal. Nyrada will initially test the efficacy of its NYR-BI02 molecule as a TRPC 3/6/7 channel blocker in a model of TBI via our existing collaboration with WRAIR. The efficacy study will use the penetrating traumatic brain injury (PTBI) model which has been developed by the WRAIR team to emulate penetrating head wounds on the battlefield. The complex nature of this study requires WRAIR to contribute considerable resources to enable its completion. Like many large research organisations globally, the ongoing COVID-19 pandemic has had an impact on some project timelines. The progression of this study is largely driven by availability of the necessary resources at WRAIR, and we expect this study to commence in the new year. Delays to the start of the TBI efficacy study will not impact the commencement of the Phase I first-in-human study as these studies can be run at the same time. The required safety, pharmacology and toxicology studies that will evaluate the safety and tolerability of Nyrada’s lead brain injury drug candidate remain on track to commence during the current quarter. With drug manufacture now complete, formulation development work is in progress to ensure a suitable dose form for intravenous administration. This will not affect the in vitro safety and toxicology studies but is necessary for the start of the in-vivo safety and toxicology studies. While continued pressure on the availability of GLP study slots at CROs due to the limited resources available during COVID-19 has made booking study slots difficult, we are in regular dialogue with the CROs to ensure these studies are progressed expeditiously. Data from these studies will determine the safe starting dose for the Phase I first-in-human study which is now expected to start in the first half of CY2023. The Phase I study will be run in Australia and will evaluate the safety and tolerability of NYR-BI02. The Phase I study will support the development of Nyrada’s drug in both TBI and stroke indications, significantly expanding the commercial opportunities potentially available to the Company. I am proud of what Nyrada has achieved this year. Our success is testament to the significant time and effort invested by our talented team. Nyrada’s transition to a clinical drug development company over the coming 6-12 months is a turning point. The team and I wish to thank you for your ongoing support and look forward to sharing news of our progress as the preclinical studies unfold and our programs advance towards the clinic. Yours Sincerely, James Bonnar CEO Nyrada Inc