Nyrada's Quarterly Report Highlights Brain Injury Drug Progress and Strategic Partnerships
NYR (NYR) Share Update July 2024 Tuesday 9th
Nyrada Announces Progress on Brain Injury Drug and Strategic Partnerships
Nyrada Inc. (ASX:NYR), a drug development company specializing in novel small molecule therapeutics, has released its Quarterly Activities Report and Appendix 4C for the period ending June 30, 2024. The report highlights significant progress in the development of its brain injury drug candidate NYR-BI03 and the establishment of a strategic partnership with Rebion.
Instant Summary:
- Nyrada on track for Phase I clinical trial of NYR-BI03 in 2QFY2025.
- GLP safety testing studies for NYR-BI03 ongoing, with results to be disclosed from 1QFY2025.
- Strategic partnership with Rebion to enhance brain injury therapy research and outcomes.
- Successful CDI subscription raising A$0.21 million.
- Cash position of A$4.77 million as of June 30, 2024.
Brain Injury Program
Nyrada is developing NYR-BI03, a first-in-class neuroprotection treatment for traumatic brain injury (TBI) and stroke. In February 2024, preclinical stroke study results showed NYR-BI03 provided a statistically significant level of neuroprotection, rescuing 42% of brain injury in the penumbra region in treated animals.
Following these promising results, Nyrada commenced Good Laboratory Practice (GLP) studies in late 3QFY2024 to assess the safety of NYR-BI03 in two animal species. The completion of these GLP studies is a prerequisite for the first-in-human clinical Phase I study, scheduled for 2QFY2025.
GLP Studies
The GLP safety assessment of NYR-BI03 includes several studies: hERG (Human Ether-a-go-go-related Gene), AMES (Bacterial Reverse Mutation Test), CNS (Central Nervous System), cardiovascular and respiratory safety, in vitro and in vivo micronucleus, and 14-day toxicity studies in two animal species. Results from the hERG and AMES studies are expected in the coming weeks, with CNS and respiratory study results to follow soon after. All study results are anticipated to be reported by early 2QFY2025.
Walter Reed Traumatic Brain Injury (TBI) Study
Nyrada's collaborative TBI study with the Walter Reed Army Institute of Research (WRAIR) began in early 4QFY2024. This study assesses the efficacy of NYR-BI03 in a rodent model of penetrating traumatic brain injury (PTBI), mimicking serious head injuries suffered by military service members. Results from this study are expected before the end of 1QFY2025.
Rebion Strategic Partnership
In late June 2024, Nyrada signed a Strategic Partnership Agreement with Boston-based medical device development company Rebion. Rebion uses Neural Performance Scanning technology to identify and monitor functional impairments in the brain from disease or injury. This partnership aims to advance therapies and outcomes for TBI sufferers through joint research, conference presentations, and applications for non-dilutive funding grants.
Phase I Human Clinical Trial
Subject to the successful completion of GLP studies, Nyrada plans to commence a first-in-human Phase I clinical trial for NYR-BI03 in 2QFY2025. This trial will assess the safety of NYR-BI03 in healthy human volunteers, confirming the safe dose range for subsequent clinical trials. Data from the stroke study, WRAIR TBI study, GLP studies, and Phase I trial will support a Phase II efficacy trial of NYR-BI03 for both stroke and TBI indications in humans.
Corporate and Financial Update
As of June 30, 2024, Nyrada had a cash position of A$4.77 million, down from A$5.60 million on March 31, 2024. The company's cash balance was bolstered during the June quarter by A$0.21 million from the issue of CDIs to Nyrada's Chair and Non-Executive Directors, on the same terms as those investors who participated in the March 2024 capital raise (A$0.075 per CDI).
Total cash operating outflows for the June 2024 quarter were approximately A$1.05 million, offset by approximately $35,000 in interest income received. The company plans to lodge an application under the Australian Government's R&D Tax incentive program for research and development expenditure undertaken in the 2024 financial year, with an estimate of the refund to be provided in Nyrada's audited financial results in August 2024.
The progress in the development of NYR-BI03 and the strategic partnership with Rebion are significant milestones for Nyrada. The commencement of Phase I clinical trials and successful GLP studies could positively impact Nyrada's stock, attracting investor interest and potentially increasing the stock price. The company's strong cash position and strategic partnerships further enhance its growth prospects.
Investor Reaction:
Investors and analysts have reacted positively to Nyrada's advancements. The strategic partnership with Rebion is seen as a strong move to enhance research capabilities and outcomes for brain injury therapies. The upcoming Phase I clinical trial is also viewed as a critical step towards bringing NYR-BI03 to market.
Conclusion:
Investors should closely monitor Nyrada's progress in the coming months, particularly the results of the GLP studies and the commencement of the Phase I clinical trial. The company's strategic initiatives and robust cash position make it a promising candidate in the drug development sector.