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NYRADA INC. AGM Information 2024

Nov 11, 2024

65469_rns_2024-11-11_0063069f-c6cd-4511-83b5-2acc444fc97d.pdf

AGM Information

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AGM Presentation

James Bonnar Chief Executive Officer

12 November 2024 | Sydney Australia

ASX:NYR

Improving Lives, Offering Hope

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

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Important Notice and Disclaimer

This presentation has been prepared by Nyrada Inc (“NYR” or “Company” ). It should not be considered as an offer or invitation to subscribe for, or purchase any securities in NYR, or as an inducement to purchase any securities in NYR. No agreement to subscribe for securities in NYR will be entered into on the basis of this presentation or any information, opinions or conclusions expressed in the course of this presentation.

This presentation is not a prospectus, product disclosure document, or other offering document under Australian law or under the law of any other jurisdiction. In particular, this presentation may not be released to US wire services or distributed in the United States.

This presentation does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States or to, or for the account or benefit of, US persons. The Company’s CDIs have not been, and will not be, registered under the US Securities Act or the securities laws of any state or other jurisdiction of the United States. The CDIs may not be offered, sold or otherwise transferred in the United States except in a transaction exempt from, or not subject to, the registration requirements of the US Securities Act of 1933 and the applicable securities laws of any state or other jurisdiction in the United States. No person in the United States may, directly or indirectly, participate in the Company’s Security Purchase Plan.

It has been prepared for information purposes only. This presentation contains general summary information and does not take into account the investment objectives, financial situation and particular needs of an individual investor. It is not a financial product advice, and the Company is not licensed to, and does not provide, financial advice.

This presentation may contain forward-looking statements which are identified by words such as ‘may’, ‘could’, ‘believes’, ‘estimates’, ‘targets’, ‘expects’, or ‘intends’ and other similar words that involve risks and uncertainties. These statements are based on an assessment of past and present economic and operating conditions, and on a number of assumptions regarding future events and actions that, as at the date of this presentation, are expected to take place.

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Such forward-looking statements do not guarantee of future performance and involve known and unknown risks, uncertainties, assumptions and other important factors many of which are beyond the control of the Company, its Directors and management.

Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, none of the Company, its Directors or officers can give, or gives, any assurance that the results, performance or achievements expressed or implied by the forwardlooking statements contained in this document will actually occur or that the assumptions on which those statements are based are exhaustive or will prove to be correct beyond the date of its making.

Readers are cautioned not to place undue reliance on these forward-looking statements. Except to the extent required by law, the Company has no intention to update or revise forward-looking statements, or to publish prospective financial information in the future, regardless of whether new information, future events or any other factors affect the information contained in this presentation.

Readers should make their own independent assessment of the information and take their own independent professional advice in relation to the information and any proposed action to be taken on the basis of the information. To the maximum extent permitted by law, the Company and its professional advisors and their related bodies corporate, affiliates and each of their respective directors, officers, management, employees, advisers and agents and any other person involved in the preparation of this presentation disclaim all liability and responsibility (including without limitation and liability arising from fault or negligence) for any direct or indirect loss or damage which may arise or be suffered through use of or reliance on anything contained in, or omitted from, this presentation. Neither the Company nor its advisors have any responsibility or obligation to update this presentation or inform the reader of any matter arising or coming to their notice after the date of this presentation document which may affect any matter referred to in the presentation.

About Nyrada

  • › Drug discovery and development company specialising in rational design of novel small molecule therapeutics.

  • › Nyrada’s lead drug candidate NYR-BI03:

  • › demonstrated strong preclinical efficacy protecting the brain from secondary injury following stroke.

  • › demonstrated strong preclinical efficacy in protecting heart following acute myocardial ischemia-reperfusion injury.

  • › preclinical TBI efficacy study with Walter Reed Army Institute of Research and UNSW in progress.

  • › Phase Ia Clinical Trial to commence end CY2024.

  • › Undertaking exploratory works for other indications and opportunities.

  • › Commercially focused business model and expert team.

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Vision and Strategy

Our Vision:

  • to become a high-growth pharmaceutical company specialising in the discovery and development of novel treatments

Our Strategy:

  • to develop treatments for diseases where there is an unmet clinical need, or where current treatments are suboptimal, and to monetise the value of these treatments through advancing clinical drug candidates towards out-licencing.

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Nyrada’s Lead Drug Candidate NYR-BI03

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First-in-Class with Novel Mechanism of Action

Significant Unmet Clinical Need and Market Opportunity

  • › NYR-BI03 is a first-in-class therapy.

  • › Targeting multiple indications.

  • › Novel mechanism of action.

  • › Australian developed innovation.

› Stroke, TBI and ischemiaReperfusion injury are leading causes of death and disability.

  • › Entering clinic in late CY2024.

  • › No current FDA approved drugs to treat these conditions.

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One Drug

NYR-BI03

Commencing Phase Ia clinical trial in late CY2024

Two Three Applications Markets

STROKE

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Neuroprotection

~ US$52.2 billion by 2032[2]

TRAUMATIC BRAIN INJURY

~US$5.5 billion by 2034[4]

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Cardioprotection

MYOCARDIAL INFARCTION

~US$3.7 billion by 2032[5]

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Neuroprotection – Stroke and TBI

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Serial reconstruction from MRI

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Secondary
Disability
30 mins Primary Injury Injury Level
BECAME STAYED THE
DIED
WORSE SAME
72 hoursIMPROVED
Hours Days Weeks Months
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Nyrada drug NYR-BI03 An acute 3-day intravenous treatment

Reduce secondary injury resulting from stroke or TBI

  • Improve survivability, limit disability

  • Improve quality of life

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Cardioprotection

Key Preclinical Results:

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NYR-BI03 showed strong efficacy limiting cardiovascular damage resulting from myocardial ischemia-reperfusion (IR) injury

  • 86% Cardioprotection

  • 43% increase in left ventricular ejection fraction

  • 50% increase in fractional shortening

Key blood biomarker markers assessed

  • 42% decrease in AST levels

  • 45% decrease in LDH levels

  • 32% decrease in Troponin I

Superior efficacy compared to FDA-approved, Captopril

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Indicative Phase I Study Design

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OBJECTIVES To assess the safety, tolerability, and pharmacokinetics of NYR-BI03

DESIGN

  • Randomised, double-blind placebo –controlled, dose escalation design

PARTICIPANTS

  • Male and female healthy volunteers

  • • 18 – 50 years age


18 – 50 years age

5 cohorts; 8 participants each
cohort; 6:2 active and placebo
treatments

3 cohorts will be single ascending
doses

2 cohorts will be given
continuous infusion doses
Active
arm
Placebo
Cohort
number
Dose administered
1 Low dose single bolus
2 Medium dose single bolus
3 High dose
4 Low dose continuous infusion (72 hrs)
5 High dose continuous infusion (72 hrs)

LOCATION & • Study will be conducted at a clinical trial centre in Australia expected to commence 4QCY2024 DURATION • Study duration will vary between 1 – 4 days

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Day 1 Day 2 Day 3
Cohorts 1, 2 & 3 Day 7 Safety assessment
Bolus delivery
Cohorts 4 & 5 Day 10 Safety assessment
Continuous infusion
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*trial design subject to ethics approval

Financial Overview and Outlook

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FY2024 Highlights and FY2025 Outlook

Operating Results Summary

  • Resources

  • › Cash balance of AU$2.98 million at 30 September 2024

  • › Expected R&D rebate of AU$1.38 million subject to Government Agency Review

  • › AU$3.36 million (before costs) in new equity capital raised in October 2024.

  • › Target AU$1.00 million (before costs) SPP to close in December 2024

FY2024 FY2023
(AU$) (AU$)
R&D Costs
Corporate and admin
expenses
2,030,502
577,842
6,411,264
641,117
Share-based payment expense 358,074 541,214
Professional services expense 477,948 409,523
Employment benefits expense 1,127,500 1,100,136
  • Programs

  • › Demonstrated preclinical neuroprotection and cardioprotection

  • › NYR-BI03 commencing Phase I clinical trial in late 2024

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Conclusion

  • Summary

  • › Pioneering transient receptor potential canonical (TRPC) channel blocking therapies.

  • › First-in-class neuroprotection and cardioprotection therapy with novel mode of action.

  • › One drug asset targeting two significant therapeutic areas and three lar e markets. g

  • News Flow

  • › Late CY2024 - NYR-BI03 Clinical Trial Commencement

  • › Earl CY2025 - WRAIR TBI stud readout y y

  • › 1HCY2025 - Progressive updates on NYR-BI03 Clinical Trial

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References

  • 1 – World Health Organization - https://www.emro.who.int/health-topics/stroke-cerebrovascularaccident/index.html#:~:text=Annually%2C%2015%20million%20people%20worldwide,cause%20i s%20high%20blood%20pressure

  • 2 – Databridge Market Research - https://www.databridgemarketresearch.com/reports/globalstroke-market .

  • 3 – National Academy of Sciences - https://nap.nationalacademies.org/catalog/25394/traumaticbrain-injury-a-roadmap-for-accelerating-progress

  • 4 – Databridge Market Research - https://www.databridgemarketresearch.com/reports/globaltraumatic-brain-injuries-treatment-market

  • 5 – Spherical Insights – https://www.globenewswire.com/en/news-

  • release/2023/05/30/2678779/0/en/Global-Myocardial-Infarction-Market-Size-To-Grow-USD-3-7Billion-By-2032-CAGR-of-6-8.html

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@nyrada_inc @nyrada_inc [email protected] www.nyrada.com

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