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NYRADA INC. — Capital/Financing Update 2024
Sep 8, 2024
65469_rns_2024-09-08_0e077256-fe2f-4347-b80b-8032dfe28a45.pdf
Capital/Financing Update
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09 September 2024
Sydney, Australia
Brain Injury Program GLP Studies Further Update 4
Highlights:
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Completed dog cardiovascular study provides ongoing data to support safety and tolerability of Nyrada’s lead Brain Injury drug candidate NYR-BI03.
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Study was satisfactorily completed under Good Laboratory Practice (GLP) conditions.
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Coupled with earlier hERG study, dog cardiovascular study completes the regulatory cardiac safety profiling of NYR-BI03.
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Nyrada will continue to 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) (“Nyrada or “Company”), a drug development company specialising in novel small molecule therapeutics provides an update on its Brain Injury program.
Nyrada is developing NYR-BI03, a first in class neuroprotection treatment for both stroke and traumatic brain injury (TBI). In February 2024, the Company reported preclinical stroke study results showing NYR-BI03 provided a statistically significant level of neuroprotection, rescuing 42% of brain injury in the penumbra region in treated animals.
In late 3QFY2024 (quarter ending March 2024), Good Laboratory Practice (GLP) studies commenced to assess safety and tolerability of NYR-BI03. In July 2024, Nyrada reported the results of hERG and AMES studies and in August 2024, Nyrada reported the results of rat CNS and respiratory studies. Today Nyrada can report that NYR-BI03 demonstrated safety and tolerability in a dog cardiovascular study.
Nyrada’s dog cardiovascular study assessed the effects of NYR-BI03 on heart function, blood pressure, and overall cardiovascular health via ECG. Coupled with the earlier hERG study, this dog cardiovascular study completes the regulatory cardiac safety profiling of NYR-BI03 necessary to commence a Phase I study.
Remaining brain injury program GLP studies will be analysed and reported as they become available.
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Nyrada Inc. Level 3, 828 Pacific Highway, Gordon NSW 2072
ARBN 625 401 818
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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).
| GLP Study | Reported |
|---|---|
| AMES | • 16 July2024 |
| hERG | • 16 July2024 |
| Rat CNS | • 06 August 2024 |
| Rat Respiratory | • 20 August 2024 |
| Dogcardiovascular safety | • 09 September 2024 |
| _In vitro_micronucleus | |
| _In vivo_micronucleus | |
| 14-dayDogToxicology | |
| 14-dayRat Toxicology |
-ENDS-
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Nyrada Inc. Level 3, 828 Pacific Highway, Gordon NSW 2072
ARBN 625 401 818
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About Nyrada Inc
Nyrada is a drug discovery and development company specialising in novel small molecule therapies. The Company has two main programs, each targeting market sectors of significant size and considerable unmet clinical need. These are a drug to treat brain injury, specifically traumatic brain injury and stroke, and a cholesterol lowering drug. Nyrada Inc. ARBN 625 401 818 is a company incorporated in the state of Delaware, US, and the liability of its stockholders is limited.
Authorised by Mr. John Moore, Non-Executive Chair on behalf of the Board.
Investor & Corporate Enquiries: Company Secretary: Dimitri Burshtein David Franks T: 02 9498 3390 T: 02 8072 1400 E: [email protected] E: [email protected]
Media Enquiries:
Catherine Strong Sodali & Co T: 02 8234 0111 E: [email protected]
Forward-Looking Statements
This announcement may contain forward-looking statements. You can identify these statements by the fact they use words such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “plan”, “should”, “target”, “will” or “would” or the negative of such terms or other similar expressions. Forward-looking statements are based on estimates, projections, and assumptions made by Nyrada about circumstances and events that have not yet taken place. Although Nyrada believes the forward-looking statements to be reasonable, they are not certain. Forwardlooking statements involve known and unknown risks, uncertainties and other factors that are in some cases beyond the Company’s control that could cause the actual results, performance, or achievements to differ materially from those expressed or implied by the forward-looking statement.
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Nyrada Inc. Level 3, 828 Pacific Highway, Gordon NSW 2072
ARBN 625 401 818