Nyrada : Quarterly Activities Report & Appendix 4C

19 April 2022

Sydney, Australia

Nyrada Quarterly Activities Report & Appendix 4C

Highlights:

• • Brain Injury Program:

  • - Exploratory study shows new lead drug candidate NYR-BI02 could be taken orally, offers potential new treatment for concussion

  • - Minimal impact from COVID-related lockdowns in China

  • - Results from preclinical stroke model study expected mid Q2 CY2022

  • - Phase I study to commence in 2H CY2022, evaluating safety and tolerability of NYR-BI02 to support clinical development in TBI and stroke

• • Cholesterol-Lowering Program:

  • - COVID-related lockdowns in China impact drug manufacture by Shanghai-based CRO delaying start of preclinical studies to Q3 CY2022

  • - Phase I first-in-human study to commence late 2H CY2022

• • Robust cash position of A$11.3 million: includes R&D tax incentive rebate of A$1.3 million received in January 2022

Nyrada Inc (ASX: NYR), a preclinical stage, drug development company specialising in novel small molecule drugs to treat cardiovascular and neurological diseases is pleased to provide its Quarterly Activities Report and Appendix 4C for the period ending 31 March 2022, and a summary of progress for its Cholesterol-Lowering and Brain Injury Programs.

Commenting on the quarter, Nyrada CEO, James Bonnar said: "Notwithstanding the delay arising from the Shanghai lockdown, both of Nyrada's lead drug development programs remain on track to commence Phase I studies in the second half of this year. We are confident that the CRO we have engaged to manufacture sufficient quantities of our cholesterol-lowering drug is doing everything possible to minimise any further delays.

"The discovery during the quarter that our new lead brain injury drug candidate, NYR-BI02 could be developed as an oral drug to treat concussion was an exciting development for the Brain Injury Program, opening the door to pursue concussion as an indication for Nyrada's drug in addition to TBI and stroke. Pleasingly, the progress of our Brain Injury Program has been minimally impacted by the lockdown and we look forward to releasing the results of the preclinical stroke model study this quarter," added Mr. Bonnar.

Preclinical Program Update

Cholesterol-Lowering Program - PCSK9 inhibitor

Preclinical Studies

The scale-up manufacture of Nyrada's lead cholesterol-lowering drug candidate for the program's preclinical studies has been delayed due to the extended COVID-related lockdown in Shanghai, China. Employees of the Shanghai-based contract research organisation (CRO) engaged by Nyrada have not been able to access laboratory worksites while the lockdown remains in place.

The CRO has advised that as areas of Shanghai progressively emerge from lockdown, they anticipate staff will return to work by the end of April to recommence drug manufacturing. As a result of the delay, Nyrada expects to commence preclinical studies at Charles River Laboratories, Inc (Charles River) during Q3 CY2022.

The Company is monitoring the situation in Shanghai closely and will continue to keep investors and the market informed as new information becomes available. In the interim, Nyrada is exploring alternative manufacturing arrangements in the event there are further delays.

Phase I Study

Based on current information, Nyrada anticipates recruitment and dosing of the first participant to commence late in 2H CY2022, pending scale-up manufacturing of the drug and ethics committee approval of the study. The Nyrada team is in regular contact with the CRO, and both are working diligently to ensure progress continues at pace.

A key advantage of the Phase I study is not only will it measure the safety and tolerability of Nyrada's drug candidate, but it will also evaluate its efficacy by measuring changes in LDL or "bad" cholesterol levels in the blood through a simple blood test. Typically, a drug's efficacy is not assessed until it is evaluated in a Phase II study.

Brain Injury Program

Potential New Oral Treatment for Concussion

Recent exploratory pharmacokinetic studies undertaken as part of Nyrada's medicinal chemistry program revealed excellent oral bioavailability of NYR-BI02, the Company's newest brain injury drug candidate. NYR-BI02 is the result of modifications made to NYR-BI01, improving the compound's overall drug-like properties and it has been selected to advance into Nyrada's Phase I first-in-human study.

NYR-BI02's excellent oral bioavailability indicates that it has the potential to be administered orally to patients who suffer a concussion, where intravenous infusion is not preferred. The convenience of an oral dosage form that can be administered in the field immediately after a concussion injury, without having to wait for hospitalisation, has the potential to significantly improve patient outcomes.

While the Company remains focused on developing a drug to treat moderate to severe TBI and stroke which would be administered intravenously, given the potential to positively impact patient outcomes and market interest in this area, Nyrada may pursue NYR-BI02's development as an oral treatment for concussion as an additional program.

Preclinical Stroke Model Study

Nyrada engaged a China-based CRO to undertake the preclinical stroke model study, which as previously announced, has been delayed due to the COVID-related lockdown in Shanghai, China with laboratory staff unable to access worksites.

Based on the latest information from the CRO, results from the preclinical stroke model study are expected to be available mid Q2 CY2022.

TBI Efficacy Study Progress

Scale-up manufacturing of the Company's lead brain injury drug candidate, NYR-BI02 for the

TBI Efficacy Study has not been materially impacted by the COVID-related lockdown in Shanghai, China. Nyrada is in regular dialogue with the CRO, as well as the Walter Reed Army Institute of Research and UNSW Sydney. The Company will provide an update to the market should there be any further developments.

Phase I Study

The Phase I first-in-human study remains on track to commence in the second half of CY2022.

The study will be run in Australia and will evaluate the safety and tolerability of the Company's preferred brain injury drug candidate, NYR-BI02.

Corporate and Financial Summary

Cash Flow & Cash Position

Total cash operating outflows for the March 2022 quarter were approximately A$1.6 million (A$1.3 million in the prior quarter). The Company reported an overall net operating cash inflow of A$311,000 for the quarter, as a result of receiving the FY2021 R&D tax incentive rebate of A$1.3 million. The Company anticipates cash outflows in future quarters will increase as both Programs progress toward Phase I clinical trials.

Investor & Corporate Enquiries:	Company Secretary:
Laura Vize	David Franks
Investor Relations Manager	T: 02 8072 1400
T: 02 9498 3390	E:[e-mail]
E:[e-mail]
Media Enquiries:
Catherine Strong
Citadel-MAGNUS
T: 02 8234 0111
E:[e-mail]
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Nyrada Inc. Level 3, 828 Pacific Highway, Gordon NSW 2072	ARBN 625 401 818

The Company has a robust cash position of A$11.3 million as at 31 March 2022 (A$11.1 million as at 31 December 2021), providing the Company with sufficient cash reserves to complete Phase I studies in both its Brain Injury and Cholesterol-Lowering programs.

In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C was approximately A$141,000 and included Director fees.

-ENDS-

About Nyrada Inc

Nyrada is a preclinical stage, drug discovery and development company, specialising in novel small molecule drugs to treat cardiovascular and neurological diseases. The Company has two main programs, each targeting market sectors of significant size and considerable unmet clinical need. These are a cholesterol-lowering drug and a drug to treat brain injury, specifically traumatic brain injury and stroke. Nyrada Inc. ARBN 625 401 818 is a company incorporated in the state of Delaware, US, and the liability of its stockholders is limited.

www.nyrada.com

Authorised by Mr. John Moore, Non-Executive Chairman, on behalf of the Board.

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. Forward-looking 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.