Nyrada GLP Studies Update

Highlights:

•Two key safety studies have provided data to support safety and tolerability of Nyrada’s lead Brain Injury drug candidate NYR-BI03.
•Both AMES and hERG in vitro studies were completed under Good Laboratory Practice (GLP) conditions with NYR-BI03 demonstrating requisite safety and tolerability.
•Nyrada will report on remaining GLP study results and remains on track to commence first in-human Phase I clinical trial for NYR-BI03 in late CY2024.

Nyrada Inc (ASX: NYR) released a Good Laboratory Practice (GLP) update for its lead Brain Injury drug candidate NYR-B103.

In late 3QFY2024 (quarter ending March 2024), GLP studies commenced to assess safety and tolerability of NYR-BI03. It is pleasing to report that NYR-BI03 demonstrated requisite safety in two (in vitro) studies: Mainly:

1.AMES (Bacterial Reverse Mutation) test – evaluated the mutagenicity and predicted the genetic risks and potential carcinogenic effects of NYR-BI03.

2.hERG (Human Ether-a-go-go-related Gene) test – evaluated the cardiovascular safety of NYR-BI03.

The remaining GLP studies are ongoing and are expected to be concluded this month, after which results will be analysed and reported as they become available.

Subject to satisfactory completion of all GLP studies, Nyrada will submit a Human Research Ethics Application with the expectation of commencing its first in human Phase I clinical trial in late 2QFY2025 (quarter ending December 2024).