NYRADA INC. — AGM Information 2022

Nov 20, 2022

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Annual General Meeting Presentation

James Bonnar Chief Executive Officer 21 November 2022│Sydney NSW

~~NYRADA INC (ASX:NYR) Authorised by Mr. John Moore, Non-Executive Chairman, on behalf of the Board.~~ ~~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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Commercially Focused Business Model

• Novel drugs for life threatening conditions with:

• High unmet clinical need

• Large market share potential

• Transitioning to a clinical stage company:

• Lead Programs entering Phase I H1 CY2023

• Strongly credentialed Board and Scientific Advisory Board:

• Track record of realising shareholder value

• Deep industry and drug development expertise

• Cash position of $9.9M (30 September 2022)

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~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Portfolio of Novel High Value Small Molecule Drugs

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	Indication	Aim	Target Market (US)	Status
Cardiovascular	Cholesterol	Best-in-class small molecule drug to	>18mPatients1	Phase I/IIa Study:
NYX-PCSK9i	Lowering	disrupt and broaden the class in CV		H1 CY2023
Oral PCSK9 inhibitor		management
Neurology	Brain Injury	First-in-class treatment to prevent	>3mPatients / year2	Phase I Study:
NYR-BI02		secondary brain injury following		H1 CY2023
TRPC 3/6/7 blocker		moderate-severe TBI, concussion,
		or stroke

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Cholesterol-Lowering Drug Program Novel small molecule PCSK9 Inhibitor

Cholesterol-Lowering Market Population, Problem, Opportunity

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

Drivers of Market Growth

• USD 18.8 billion in 2021 (USD 14.7 billion statin drugs)[4]

• Increasing rate of high cholesterol in patients

• Est. sales revenue USD 30 billion by 2027 ( CAGR 8% )[5]

• Awareness of the benefits of cholesterol-lowering drugs

• New treatment options entering the market

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Current PCSK9 Injectable Drugs Expensive and Inconvenient

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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

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Expensive to manufacture

Insurer / patient co-pay reluctance (US)

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•
•
•
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• Patient convenience : once per day oral treatment

Competitive advantages of a small molecule PCSK9 inhibitor

• Lower manufacturing cost

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

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Benchmarking Efficacy NYX-PCSK9i +/- Lipitor[®] in Transgenic Mouse Hyperlipidemia Model

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Study Objective:

Determine if additive reduction in total cholesterol can be achieved with combination statin therapy

• APOE*3Leiden.CETP mouse hyperlipidemia model

• Mouse treated for 35 days (50 mg/kg BID NYX-PCSK9i)

Results:

• NYX-PCSK9i + Lipitor[®] achieves 65% total cholesterol reduction

• No effect on body weight, food intake, liver enzymes

• Study published in Journal of Lipid Research (Oct 2022)

		% Difference in plasma cholesterol versus	% Difference in plasma cholesterol versus	% Difference in plasma cholesterol versus	% Difference in plasma cholesterol versus	% Difference in plasma cholesterol versus
		vehicle control (p-value)
Time (days)		7	14			35
NYX-PCSK9i		-18% (0.066)	-24%(0.002)			-46%(<0.001)
Lipitor®		-13% (0.275)	-15%(0.077)			-27%(<0.001)
NYX-PCSK9i + Lipitor®		-33%(<0.001)	-49%(<0.001)			-65%(<0.001)
bold =statistically significant

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~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Efficacy in Model of Atherosclerosis NYX-PCSK9i in Human Tissue-Engineered Blood Vessel Model[6]

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Study Design​

• Researchers at Duke University (US) used human stem cells to create tissue-engineered blood vessels (TEBVs), replicating early features of atherosclerosis

• Evaluated the effect of PCSK9 inhibitor drug on inflammation and atherosclerotic plaque formation​, a major cause of cardiovascular disease

Results:

• Optimised analog of NYX-PCSK9i reduced cell adhesion (blocking atherosclerotic plaque formation)

• Nyrada’s drug candidate reduced inflammatory response (cytokine levels) – a key driver of atherosclerosis

• Optimised analog of NYX-PCSK9i selected for Phase I

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No Drug
WT
P+
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With Drug
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2
Monocytes/cm
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~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Phase I/IIa Study Design

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• OBJECTIVES • Evaluate safety, tolerability, and pharmacokinetics of optimised NYX-PCSK9i in healthy volunteers and high cholesterol patients • Exploratory evaluation of cholesterol metabolism in high cholesterol patients

PARTICIPANTS

• 8 cohorts (6 active: 2 placebo per cohort)

• Cohorts 1-6 : 48 healthy volunteers

• Cohorts 7,8 : 16 high cholesterol patients,

• 8 taking statins

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Active arm
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Placebo

DESIGN

• Double-blind, randomised, placebo-controlled, dose escalation study

• Healthy volunteers :

Single ascending oral dose (Cohorts 1-6)

• High cholesterol patients :

• Once daily oral dose over 14-day treatment period (Cohort 7 no statins, Cohort 8 statin co-treatment)

• Pharmacokinetic and pathology samples will be collected at selected time points over the trial period for all subjects.

LOCATION &

DURATION

• Study will be conducted at a clinical trial centre in Australia in H1 CY2023

• The dosing period will be 1 day in healthy volunteers and 14 days in high cholesterol patients

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Day 1 Day 2 Day 3
Cohorts 1-6
Safety, Tolerability & PK
Cohorts 7-8
+ Exploratory Efficacy
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Day 14
Data
analysis
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*trial design subject to ethics approval

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATIO~~ N

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Acceleration of Clinical Program

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Phase I modified
Scale-up drug Combined Phase
to include high
manufacture I/IIa study to start
cholesterol
completed H1 CY2023
patients
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Accelerates
Speeds transition
efficacy
to Phase IIb and
assessment in
IND Application
target patient
with FDA
population
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 Smart and efficient use of capital

 Quick transition from Phase I/IIa to Phase IIb study, time saving of up to 12 months

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Program Milestones

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2H CY2020 1H CY2021 2H CY2021 2022 and Beyond JUL 2021 CY2022 - CY2023 DEC 2020 MAY 2021 DEC 2021 USPTO grants patent Preclinical studies to commence in NYX-PCSK9i shows Potent new drug for Nyrada’s US CRO appointed to H2 CY2022 57% reduction in total candidates identified PCSK9i inhibitor conduct preclinical Phase I first-in-human clinical trial cholesterol in mouse technology studies in US to commence H1 CY2023 study JULY 2020 JAN 2021 JUN 2021 AUG 2021 JUNE 2022 OCT 2022 NYX-PCSK9i NYX-PCSK9i well NYX-PCSK9i NYX-PCSK9i mechanism of EPO grants patent Efficacy study demonstrates ex vivo tolerated, lowers reduces total action confirmed following for Nyrada’s published in equivalency to Repatha[®] LDL cholesterol in cholesterol by 65% further exploratory analysis PCSK9i inhibitor Journal of Lipid and Praluent[®] a dose-dependent when given in technology Research manner combination with a statin, outperforms Lipitor[®] (atorvastatin, Pfizer) JULY 2022 Nyrada’s PCSK9 inhibitor blocks early stages of atherosclerosis in novel model at Duke University

~~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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Each year
+12.2 million
55 million
suffer a stroke [8]
Each year People are living with the effects
of medically treated TBI [7]
One drug class for stroke (tPA)
~5.5 million
suitable for >15% of patients
People suffer a severe TBI [7]
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TBI Treatment • USD 6.7 billion sales revenue in 2020 Market (US, UK, Europe, Japan)[9] • Sales revenue CAGR 5% to 2030[9] • Stroke Drug USD 3.4 billion global revenue in 2018[10] Market (tPA) • Sales revenue CAGR 7% to 2027[10]

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~~

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Brain Injury Trajectory, Patient Outcomes, Treatment Aims

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Primary Secondary Disability
Injury Injury Level
Hours Days Weeks Months
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- 11
5 Year Patient Outcomes following TBI
30%
26%
22% 22%
BECAME STAYED
DIED IMPROVED
WORSE THE SAME
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Data are US population estimates based on the TBIMS National Database. Data refer to people 16 years of age and older who received inpatient rehabilitation services for a primary diagnosis of TBI.

• Reduce secondary injury resulting from TBI or stroke

• Nyrada drug NYR-BI02 • Improve survivability, limit disability

• An acute 3-day intravenous treatment • Improve quality of life

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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TRPC 3/6/7 Ion Channels as a Therapeutic Target[12]

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• Glutamate release following brain injury results in calcium entry via TRPC ion channels

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• Excessive calcium build-up leads to neuronal cell death

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•
Blocking TRPC 3/6/7 ion channels is neuroprotective against secondary brain injury
Ca [2+]
TRPC 3/6/7
ion channels
Glutamate
Extracellular matrix
Plasma membrane mGluR
1/5
DAG
PLC-β
Gαq
Intracellular space
GTP
Ca [2+]
Neuronal death
(loss of brain function)
IP
3
Ca [2+]
IP R
3
Activation of astrocytes and microglia
(Neuroinflammation)
Endoplasmic Reticulum
Ca [2+] internal stores
2
PIP
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~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Proof of Concept Knockout Model shows Neuroprotection

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TTC Staining

Functional Improvement following Brain Injury in TRPC 3/6/7 KO Mice[13]

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Adapted from Chen et al. Mol. Neurobiol. 2017

• TRPC 3/6/7 KO mice have significantly smaller lesion sizes compared to WT

• TRPC 3/6/7 KO mice have significantly better neurological score compared to WT

• Nyrada molecule NYR-BI02 blocks TRPC3/6/7 channels (IC50 = 0.6 µM)

• NYR-BI02 will be tested in models of TBI (WRAIR) and stroke CY2023

~~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-BI02

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 H1 CY2023 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
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*trial design subject to ethics approval

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Program Milestones

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2H CY2020 CY2021
FEB 2021
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• Collaboration secured with WRAIR and UNSW Sydney

JUL 2020

JUN 2021

• Nyrada Brain Injury Data published at the premier US Military Health conference, US Military Health System Research Symposium

• New, more potent analog of Nyrada’s brain injury candidate identified (NYR-BI01)

• Pilot work to optimise PTBI model, drug formulation and delivery, and MRI scanning, (WRAIR & UNSW Sydney)

• Drug candidates successfully delivered by continuous intravenous infusion, maintaining effective therapeutic levels in the brain, with no adverse effects observed

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• Pilot study evaluating the intranasal route of delivery for drug candidates

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CY2022 and Beyond

• MAR 2022 MAY 2022 • NYR-BI02 • Provisional selected for patent Phase I study application filed

UPCOMING

• Brain injury drug candidate testing in preclinical model of stroke in Q4 CY2022

• Complete PTBI efficacy study

• Phase I first-in-human study anticipated to commence first half of CY2023

• Study will support Phase II development in Moderate-severe TBI and stroke (acute IV dosing)

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Targeting Non-Dilutive Funding

Walter Reed Army Institute of Research (WRAIR)

• Pursuing opportunities for post Phase I funding

• Potential support for clinical development available through Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI):

• Access to >20 clinical trial sites at Level 1 Trauma Centres at US Hospitals

• Close ties with US Department of Defense (DoD)

• Pivotal in providing non-dilutive funding to support TBI drug development

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• TBI continues to be primary focus of WRAIR and US DoD

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~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Corporate Snapshot

ASX:NYR

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Corporate Overview

Key Metrics Market capitalisation A$18.7M (as at 18 November 2022) Share price A$0.12 (as at 18 November 2022) CDIs free float 156,008,700 Cash at bank 30 September 2022: • A$9.9M Funded to pursue Phase clinical development in CY2023 ASX listing January 16, 2020

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~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Upcoming Newsflow[*]

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Cholesterol-Lowering
Program Start of Phase I Study
Phase I Study
initial results
Read-outs from
Preclinical safety Final results of
preclinical safety and
and toxicology Phase I Study
toxicology studies
studies started
Q4 H1 H2 H1
CY2022 CY2023 CY2023 CY2024
Preclinical stroke Final results of
model study Phase I Study
Read-outs from
Phase I Study
preclinical safety
initial results
and toxicology
Preclinical safety
studies Phase I Study
and toxicology
commences
studies started
Brain Injury Program TBI Efficacy Study
with WRAIR
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*Estimated timings and subject to change

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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FY2022 Financial Performance

Highlights

• Nyrada ended FY2022 with cash of $10.8M

• Cash position as at the end of Q1 FY2023 was $9.9M

• R&D Tax Incentive refund of ~$1.2M received in November 2022, further boosting capital resources

• Well funded to pursue Phase I clinical development in CY2023

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Operating Results Summary

	FY2022 (A$)	FY2021 (A$)
R&D Costs	1,835,072	2,175,050
Corporate and admin expenses	699,653	895,839
Share-based payment expense	966,951	1,111,622
Professional services expense	338,841	509,842
Employment benefits expense	1,000,030	929,931

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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References

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• 1 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

• 2 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

• 3 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

• 4 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

• 5 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

• 6 Adapted from Zhang et al. Nat Commun. 2020. 11(1): 5426 and modified from Nature cell biology, 17(8), 994-1003

• 7 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

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

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

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

• 11 ‘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

• 12 Jeon J, Bu F, Sun G, Tian J,Ting S, Li J,Aronowski J, Birnbaumer L, Freichel M, and Zhu MX (2020). Contribution of TRPC Channels in Neuronal Excitotoxicity Associated With Neurodegenerative Disease and Ischemic Stroke. Front Cell Dev Biol. doi: 10.3389/fcell.2020.618663

• 13 Chen X, Lu M, He X, Ma L, Birnbaumer L, and Liao, Y. (2017). TRPC3/6/7 knockdown protects the brain from cerebral ischemia injury via astrocyte apoptosis inhibition and effects on NF-small ka, CyrillicB translocation. Mol. Neurobiol. 54, 7555–7566. doi: 10.1007/s12035-016-0227-2

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Brain Injury Solution Cholesterol-Lowering Animation Animation

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@nyrada_inc @nyrada_inc ASX:NYR info@nyrada.com ~~NYRADA INC (ASX:NYR) 26~~

www.nyrada.com ~~AGM PRESENTATION~~