Nyrada Inc. provided an update on the progress of its Brain Injury Program. Preclinical Studies: Formulation Development: The formulation development work necessary to ensure Nyrada can deliver an optimal dose form suitable for intravenous administration of brain injury drug candidate is progressing well. This work is essential for the upcoming in vivo safety and toxicology studies, the scheduled Phase I trial and stroke model study.

Safety Toxicology and Pharmacology Studies: As previously announced, the in vitro safety and toxicology studies have started and continue to advance as anticipated, with in vivo studies to follow. The required in vitro and in vivo preclinical studies will be used to evaluate the safety and tolerability of Nyrada's drug. This is a necessary part of the drug development process given Nyrada's candidate has not been tested in humans.

Data from these studies will determine the safe starting dose for the Phase I study. Stroke Model Study: The efficacy of Nyrada's brain injury drug candidate is being evaluated in a well-established preclinical stroke model. This model was previously used by Nyrada to test the efficacy of its first-generation molecule, which showed a promising efficacy signal.

The Company previously indicated that this study would be undertaken in the latter part of Fourth Quarter CY2022, with results expected early in the new year. However, additional time has been required to progress the formulation development work, resulting in a slight delay to the commencement of the stroke model study. Nyrada now expects the results of the stroke model study to be available during the first quarter of this year.

The stroke study is outside of the work being undertaken as part of Nyrada's collaboration with the Walter Reed Army Institute of Research (WRAIR) and UNSW Sydney. WRAIR's focus remains solely on developing a drug to mitigate the impact of TBI on military service members. Phase I Study: The Company's expectations as to the commencement of a Phase I first-in-human study for its Brain Injury Program remain unchanged, with the study to start in the first half of CY2023.

The study will evaluate the safety and tolerability of Nyrada's brain injury drug candidate and will be run in Australia.