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NYRADA INC. AGM Information 2023

Nov 19, 2023

65469_rns_2023-11-19_3b2f49ae-0845-49e3-a6d2-331829b500f7.pdf

AGM Information

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~~NYRADA INC (ASX:NYR) 1 AGM PRESENTATION~~

Important Notice & Disclaimer

This presentation has been prepared by Nyrada Inc (NYR or the Company ). It should not be considered as an offer or invitation to subscribe for, or purchase any shares in NYR, or as an inducement to purchase any shares 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. 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. 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.

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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 forward-looking 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.

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Nyrada’s Vision, Strategy, and Values

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Our vision

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

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Our strategy
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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-licensing.

Advancing our strategy

Delivering upon our vision and strategy through our two current target markets - for brain injury via a TRPC ion channel blocker, and for cholesterol-lowering via an oral PKSK9 inhibitor.

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Better Health Improving patient health is at the heart of Outcomes everything we do. We say what we mean and deliver on our promises, both to each other and our Straight Talking stakeholders. We are transparent and act with integrity in everything we do. We accept our differences and recognise that Diversity is a a variety of experiences and backgrounds Strength creates a stronger team. We know we achieve more working together than alone. We leverage insights and outside-the-box Innovation thinking to turn complex problems into simple Excellence solutions. We seek to push the boundaries to truly see what’s possible. We are quick to anticipate obstacles and can pivot and adapt to ensure we stay on course. Resilience

We are quick to anticipate obstacles and can pivot and adapt to ensure we stay on course. We are agile in our thinking and embrace different points of view.

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

~~3~~

Commercially Focused Business Model with Structural Strengths

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We aim to create value for patients and shareholders by advancing optimized, clinic-stage drug candidates towards out-licensing.

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Lean, scalable Experienced Large molecule Attractive Highly capable team operating governing and library operating with strong small model advisory environment – molecule Med-Chem boards patent protection, expertise R&D rebate

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Key Programs and Target Markets

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Drug Candidate Indication Aim Target Market (US) Status
Neurology
TRPC 3/6/7 blocker
Brain Injury First-in-class treatment to prevent
secondary brain injury following
moderate-severe TBI, concussion,
or stroke
>3mPatients / year1 GLP Studies ongoing
Phase I Study:
2H CY2024
Cardiovascular
Oral PCSK9 inhibitor
Cholesterol
Lowering
Best-in-class small molecule drug
to disrupt and broaden the class
in CV management
>18mPatients2 Analogue library review
Low-cost background
works

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Brain Injury Drug Program

Novel small molecule TRPC 3/6/7 blocker

Brain Injury Market Population, Problem, Opportunity

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55 million
Each year People are living with the effects
of medically assessed TBI [3]
~5.5 million
People suffer a severe TBI [3]
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Each year
+12.2 million
suffer a stroke [4]
One drug class for stroke (tPA)
suitable for >15% of patients
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  • TBI Treatment • USD 6.7 billion sales revenue in 2020 Market (US, UK, Europe, Japan)[5]

  • Sales revenue CAGR 5% to 2030[5]

  • Stroke Drug USD 3.4 billion global revenue in 2018[6] Market (tPA) • Sales revenue CAGR 7% to 2027[6]

Problem and Opportunity

  • Unmet clinical need with no approved drugs for TBI and limited treatment options for stroke

  • Effective treatment will improve patient outcomes and reduce high costs associated with long-term care of brain injury survivors

  • Moderate to severe TBI is an orphan indication

Nyrada is developing a first-in-class neuroprotectant drug to prevent secondary injury

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

~~7~~

Brain Injury Trajectory, Patient Outcomes, Treatment Aims

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Serial reconstruction from MRI
Primary Secondary Disability
Injury Injury Level
30 mins
BECAME STAYED
DIED
WORSE THE SAME
72 hours IMPROVED
Hours Days Weeks Months
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Nyrada drug NYR-BI03

An acute 3-day intravenous treatment

Reduce secondary injury resulting from TBI or stroke

  • Improve survivability, limit disability

  • Improve quality of life

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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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

  • 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

PARTICIPANTS

  • Male and female healthy volunteers

  • 18 – 50 years age

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Cohort number Dose administered
1 Low dose single bolus
2 Medium dose single bolus
Active arm
3 High dose
Placebo 4 Low dose continuous infusion (72 hrs)
5 High dose continuous infusion (72 hrs)
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LOCATION & • Study will be conducted at a clinical trial centre in Australia 2H CY2024 DURATION • The study duration will vary between 1 – 4 days

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Day 1 Day 2 Day 3
Cohorts 1, 2 & 3 Bolus Day 7 Safety assessment
delivery
Cohorts 4 & 5 Day 10 Safety assessment
Continuous infusion
trial design subject to ethics approval
NYRADA INC (ASX:NYR) 9 AGM PRESENTATION
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Cholesterol Lowering Drug Program Novel small molecule PCSK9 Inhibitor

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Cholesterol Lowering Market Population, Problem, Opportunity

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56 million
18.4 million
between ages 40 and 75 Unable to achieve
treatment eligible
LDL-C target despite taking a statin [1]
62.6 million
27.4 million 1 in 5 patients
Americans have high cholesterol [1] statin intolerant [3]
taking a statin [1]
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Global Cholesterol Drugs Market

Drivers of Market Growth

  • USD 18.8 billion in 2021 (USD 14.7 billion statin drugs)[8]

  • Increasing rate of high cholesterol in patients

  • Est. sales revenue USD 30 billion by 2027 ( CAGR 8% )[9]

  • Awareness of the benefits of cholesterol-lowering drugs

  • New treatment options entering the market

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

~~11~~

Current PCSK9 Injectable Drugs Expensive and Inconvenient

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Competitive advantages of a small molecule PCSK9 inhibitor

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Effective when combined with statin treatment

Expensive US$5,800 to US$6,500 per year

Inconvenient for patient / poor compliance

Expensive to manufacture

Insurer / patient co-pay reluctance (US)

  • Patient convenience : once per day oral treatment

  • Lower manufacturing cost

  • Dose form can be combined with a statin (single pill)

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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~~NYRADA INC (ASX:NYR) 13 AGM PRESENTATION~~

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Corporate
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Financial Overview and Outlook

FY2023 Highlights and FY2024 Outlook

  • Resources:

  • Cash balance of $3.7M at end of June 2023

  • Cash balance of $2.3M at end of September 2023

  • R&D Tax Incentive refund of approximately $3.2M anticipated subject to Government Agency review.

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Operating Results Summary

FY2023 (A$) FY2022 (A$)
R&D Costs 6,411,264 1,835,072
Corporate and admin expenses 641,117 699,653
Share-based payment expense
Professional services expense
541,214
409,523
966,951
338,841
Employment benefits expense 1,100,136 1,000,030
  • Programs

  • Advancing Brain Injury program candidate (NYX-BI03) to GLP testing and clinic

  • Cholesterol Lowering program development reset

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Summary & News Flow

  • Brain Injury • Completion of candidate GLP studies of NYXBI03

  • Expected commencement of Phase I clinical trial for NYX-BI03 H2 CY2024

  • Cholesterol Lowering • Review of analogue library

  • Low-cost background works

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Corporate
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  • Ongoing cost management initiatives

  • Non dilutive funding applications in US and AU

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~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Thank you for your attention and your support!

Questions?

~~AGM PRESENTATION~~

~~NYRADA INC (ASX:NYR)~~

~~16~~

References

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  • 1 Brain Injury Alliance (Connecticut): http://www.biact.org/understanding-brain-injury/brain-injury-facts-statistics and US Centers for Disease Control and Prevention: https://www.cdc.gov/stroke/facts.htm

  • 2 Wong ND et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US. J Clin Lipidology. 2016

  • 3 National Academies of Sciences, Engineering, and Medicine 2022. Traumatic Brain Injury: A Roadmap for Accelerating Progress. Washington, DC: The National Academies Press. https://doi.org/10.17226/25394

  • 4 World Stroke Organisation (WSO): Global Stroke Factsheet 2022,Valery L Feigin et al, International Journal of Stroke 2022, Vol. 17(1) 18–29

  • 5 Global Traumatic Brain Injury Market to 2030 - Insight, Epidemiology and Forecast by ResearchAndMarkets.com

  • 6 Stroke Treatment Market Insight and Trends 2027 - TMR (transparencymarketresearch.com)

  • 7 ‘Moderate to Severe Traumatic is a Lifelong Condition’, CDC publication available at: https://www.cdc.gov/traumaticbraininjury/pdf/moderate_to_severe_tbi_lifelong-a.pdf

  • 8 Management of Statin Intolerance in 2018: Still More Questions Than Answers, Toth PP, Patti AM, Giglio RV, Nikolic D, Castellino G, Rizzo M, Banach M. Am J Cardiovasc Drugs. 2018 Jun;18(3):157-173

  • 9 Cholesterol Lowering Drug Market Research Report by Disease Type, Class of Drug, Distribution Channels, Region - Global Forecast to 2027 - Cumulative Impact of COVID-19, July 2022 and Global Statin Market – Industry Trends and Forecast to 2029, Data Bridge Market Research

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Brain Injury Solution Cholesterol-Lowering Animation Animation Authorised by Mr. John Moore, Non-Executive Chair, on behalf of the Board. @nyrada_inc @nyrada_inc ASX:NYR [email protected] www.nyrada.com ~~NYRADA INC (ASX:NYR) 18 AGM PRESENTATION~~