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NYRADA INC. AGM Information 2021

Nov 18, 2021

65469_rns_2021-11-18_4bd2c97b-97b4-4bb2-b82b-7e86aa50cc01.pdf

AGM Information

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Annual General Meeting Presentation

James Bonnar Chief Executive Officer 19 November 2021│Sydney NSW

~~Authorised by Mr. John Moore, Non-Executive Chairman, on behalf of the Board.~~ ~~1~~

~~NYRADA INC (ASX:NYR)~~

~~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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Company Overview

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  • Drug discoverer and early-stage developer

  • Two lead drug development programs with significant therapeutic and commercial potential:

  • Cholesterol-Lowering Program

  • Brain Injury Program

  • Lead drug development programs funded through Phase I

  • Collaborations with world leading institutions, Walter Reed Army Institute of Research (WRAIR) and UNSW Sydney

  • Cash position as at the end of Q1 FY2022 was $12.4M

  • Commercial business model focused on maximising the value of early-stage drug candidates

  • Well connected industry and research experts comprise Nyrada’s Board and Scientific Advisory Board (spanning US, Europe, Japan and Australia)

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

~~3~~

Vision & Strategy

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  • To improve lives and offer hope through innovation

  • We aim to deliver novel treatments for diseases where:

  • There is an unmet clinical need; or

  • Current treatments are suboptimal

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Our strategy is to advance highly optimised drug candidates towards a key value inflection point , such as an efficacy signal, and out-licence them early , where the risk reward equation is most favourable for Nyrada shareholders

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Cholesterol-Lowering Program

ASX:NYR

~~AGM PRESENTATION~~

~~NYRADA INC (ASX:NYR)~~

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High LDL Cholesterol and Cardiovascular Disease (CVD) Problem and key statistics

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High LDL cholesterol
a leading cause of CVD
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CVD responsible for Healthcare costs for CVD
1 in 4 deaths ~US$363B/year (US) [1]
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Statins are suboptimal for 70% of patients and often poorly tolerated

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62M US adults with 27M US adults take 19M unable to reach target
high LDL cholesterol [2] a statin drug [2] despite statin treatment [2]
Statins reduce risk of CVD but ~1 in 5 patients are statin intolerant, a key reason treatment is discontinued [3]
Intolerance symptoms include muscle pain, liver dysfunction, renal insufficiency, diabetes and eye conditions [4]
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  • 1 Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, et al. Heart disease and stroke statistics - 2021 update: A report from the American Heart Association, 2021; average annual indirect and direct CVD related costs estimated for 2016-17.

  • 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 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 Cai T, Abel L, Langford O, Monaghan G, Aronson J K, Stevens R J et al. Associations between statins and adverse events in primary prevention of cardiovascular disease: systematic review with pairwise, network, and dose-response metaanalyses, BMJ 2021

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Current PCSK9 inhibitors

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  • Effective as a single treatment or combined with a statin

  • × Expensive (~US$5,800/year) and require 2-4 weekly injections

  • Amgen and Sanofi/Regeneron reduced the price of their injectable PCSK9 inhibitors, Repatha® (evolocumab) and Praluent® (alirocumab) by 60%, supporting increased sales and patient uptake[1]

  • Repatha® sales grew 34% in FY2020 to US$887M[1]

  • Leqvio® (inclisiran, Novartis) recently approved in Europe[2]

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  • Three then six-monthly injections on top of statin treatment

  • Merck & Co announced results from two early clinical studies showing the first version of an oral PCSK9 inhibitor cholesterol-lowering medicine was well tolerated and highly effective at reducing high levels of LDL cholesterol[3]

  • Demonstrates industry interest in development of oral vs injectable PCSK9 inhibitors

  • Improved access to injectable PCSK9 inhibitors through government health benefit schemes:

  • Repatha® and Praluent® now funded under PBS (Australia) but only for patients with familial hypercholesterolemia[4]

  • Leqvio® to be funded by NHS in UK for 300,000 patients with negotiated discount (undisclosed) to list price of US$2,750 per dose[5]

1 Amgen press release dated 24 October 2018 , Regeneron press release dated 11 February 2019, FY2020 Amgen Annual Report, page 64 2 Novartis press release dated 11 December 2020

3 Results from clinical studies by Merck & Co. presented at the American Heart Association’s Scientific Sessions 2021, 15 November 2021

4 Sanofi press release dated 1 August 2021; Australian Federal Department of Health press release dated 1 May 2020

5 ‘Novartis finalizes deal to make new heart drug widely available in England’, Shoshana Dubnow, Biopharmadive, 1 September 2021

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Nyrada’s Program

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  • We are developing an oral PCSK9 inhibitor drug (taken as a pill) for the treatment of high LDL (bad) cholesterol levels in patients at risk of cardiovascular disease

  • Nyrada’s drug would replace expensive and inconvenient injectable PCSK9 inhibitor drugs and could be taken on its own or in combination with a statin

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

~~8~~

Program Milestones – FY2021 & FY2022

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Medicinal chemistry
program reveals new
potent drug NYX-PCSK9i
NYX-PCSK9i shows candidates mechanism of action
57% reduction in total confirmed by
cholesterol [1] increased plasma
Mid
Jan June July PCSK9 levels [1]
July CY
2020 2021 2021 2021
2022
1H FY2021 2H FY2021 1H FY2022 UPCOMING
Dec May US Patent & Trademark Aug
NYX-PCSK9i
2020 2021 Office issue first patent 2021
demonstrates
for Nyrada’s PCSK9i
equivalency to FDA
inhibitor technology
approved Repatha®
and Praluent®
NYX-PCSK9i reduces Completion of safety
NYX-PCSK9i well tolerated, total cholesterol by 65% pharmacology and toxicology
lowers LDL cholesterol in a when given in studies expected mid CY2022,
dose-dependent manner [1] combination with a statin, Phase I first in human study to
outperforms Lipitor® follow
(atorvastatin, Pfizer) [1]
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1 In vivo study conducted in specialised mouse model (APOE*3-Leiden.CTP) genetically modified to mimic human-like characteristics concerning cholesterol metabolism and cardiovascular health.

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Brain Injury Program

ASX:NYR

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Global Market with Large Unmet Need - Brain Injury After TBI or Stroke

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Nyrada is developing a neuroprotectant drug to reduce the impact of secondary brain injury in patients following a stroke or traumatic brain injury ( TBI ), which can occur following a motor vehicle accident, fall, or sporting injury.

TRAUMATIC BRAIN INJURY is a global problem affecting millions, yet there is no FDA approved drug available and treatment options are limited to neurosurgery and supportive care

  • 2.8 million TBIs in US[1 ]

  • 4.1 million TBIs globally (2020)[2]

  • 5.3M Americans living with brain injury[3]

  • 800,000 strokes annually (US)[3]

  • STROKE

  • 800,000 strokes annually (US)[4]

  • One drug class for stroke, suitable to less than 15% of patients

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- 5
5 Year Outcomes of Persons with TBI
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30%
26%
22% 22%
BECAME STAYED IMPROVED
DIED
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.

  • 1 Brain Injury Alliance (Connecticut): http://www.biact.org/understanding-brain-injury/brain-injury-facts-statistics

  • 2 Total TBIs in US, Germany, France, Italy, Spain, UK and Japan, Traumatic Brain Injury, Market Insight, Epidemiology and Market Forecast, DelveInsight, published January 2021 3 US Brain Injury Alliance: https://usbia.org/

  • 4 US Centers for Disease Control and Prevention: https://www.cdc.gov/stroke/index.htm

  • 5 ‘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

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

~~11~~

Reducing Secondary Brain Injury After TBI or Stroke First-ever drug to improve survivability and patient quality of life

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  • Treatment for secondary brain injury following TBI or Stroke

  • Administered intravenously (TBI and Stroke) or intranasally (Concussion)

  • Prevent cell death

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Primary Secondary Disability
Injury Injury Level
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  • Attenuate damaged brain volume

  • Improve survivability, limit disability, improve quality of life

  • In the US, UK, Europe and Japan alone, the size of the TBI market in 2020 was US$6.7 billion and estimated to grow at a CAGR of 5.54% between 2018–2030[1]

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  • Stroke market estimated to surpass US$3.5B by 2027[2]

HOURS

DAYS

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WEEKS MONTHS
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1 Traumatic Brain Injury, Market Insight, Epidemiology and Market Forecast, DelveInsight, published January 2021

2 Coherent Market Insights press release dated 10 May 2021

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

~~12~~

Program Milestones – FY2021 & FY2022

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Pilot work commenced to
Pilot study
Collaboration determine the baseline End 2H
July evaluating the secured with June injury signal in TBI animal CY CY
2020 intranasal route of delivery for WRAIR and 2021 models that are expected 2021 2022
UNSW Sydney to be used in the studies
drug candidates
1H FY2021 2H FY2021 UPCOMING
New, more potent
Nyrada Brain Injury Feb analogue of Nyrada’s Initial results from
Drug candidates
premier US Military Data published by successfully delivered by continuous intravenous 2021 (NYR-BI01) to be taken brain injury candidate, WRAIR’s animal TBI testing NYR-BI01 in
Health conference, US forward into studies with model are expected
injection, maintaining
Military Health System effective therapeutic levels WRAIR and UNSW before the end of 2021
Research Symposium in the brain, with no
adverse effects observed
Phase I first in human study
anticipated to commence
second half of 2022
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~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Corporate Update

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

ASX:NYR

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FY2021 Financial Performance

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Highlights

  • Nyrada ended FY2021 with cash of $13.8M

  • Cash position as at the end of Q1 FY2022 was $12.4M

  • R&D Tax Incentive refund of $2.3M relating to the accrued FY2021 refund of $1.3M and received FY2020 refund of $1.0M

  • Anticipate R&D Tax Incentive refund of $1.3M in Q4 CY2021, further boosting capital resources

  • Capital raise of $11.5M completed via a two-tranche Placement, with strong demand from new and existing shareholders

Operating Results Summary

FY2021 (A$) FY2020 (A$)
R&D Costs 2,175,050 1,399,999
Corporate and admin expenses 895,839 571,862
Share-based payment expense 1,111,622 2,204,324
Professional services expense 509,842 1,005,316
Employment benefits expense 929,931 1,342,993
  • Placement proceeds will be used to fund Phase I clinical trials for both programs, and enable further proof-of-concept studies

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Strong Intellectual Property Position

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  • In July 2021, the US Patent & Trademark Office granted Nyrada’s first patent for the CholesterolLowering Program’s PCSK9i inhibitor, with an expiry date of 16 March 2038

  • The composition of matter patent protects Nyrada’s intellectual property for its PCSK9 inhibitor technology in the US and marks an important achievement in our active IP strategy

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~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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COVID Update

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  • No significant impact on operations despite multiple government mandated COVID-19 lockdowns in Sydney and Melbourne

  • Successfully transitioned to remote working model

  • Team appreciate greater flexibility, leading to enhanced productivity and morale

  • Remote working model reduces fixed costs and frees up capital to invest back into R&D activities

  • Minimal disruption to CROs engaged overseas to undertake preclinical studies (China, India)

  • Relaxation of COVID-19 restrictions including international travel will allow for greater focus on in-person investor engagement, and conference presentations (market and industry) in CY2022

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Scientific Advisory Board

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Professor Gary Housley Chair, M.Sc Ph.D

Professor David Burke MD, DSc, AC

Chair in Physiology (UNSW) and founding Director of the Translational Neuroscience Facility.

Professor of Neurology at Royal Prince Alfred Hospital and Sydney Medical School (USYD).

Pioneered the science behind Nyrada’s Brain Injury Program.

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Professor Gilles Lambert

Ph.D

Professor in Cell Biology at

University of La Réunion Medical School (France) and group leader, Inserm laboratory of Diabetes & Atherothrombosis of the University Hospital of La Réunion.

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Professor Junichi Nabekura, Ph.D

Professor of Physiology and Neuroscience and Director General of the National Institute of Physiological Sciences, a leading research institution in Japan.

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Dr. Jim Palmer Ph.D

More than 30 years of experience in drug discovery programs targeting oncology, cardiovascular, inflammation, joint and bone disease, and infectious diseases.

~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Key Metrics & Timing of Phase I Studies

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Market capitalisation $36.6M (as at 18 November 2021) Share price $0.235 (as at 18 November 2021) CDIs free float 122,902,847 CDIs 24 months escrow 33,105,853 Cash at bank 30 Sept 2021 A$12.4M ASX listing January 16, 2020

1H 2H CY2022 CY2022

Program Pathways to Phase I Cholesterol-Lowering Program Expect to enter clinic following completion of preclinical studies in Mid CY2022 Brain Injury Program Expect to enter clinic in 2H CY2022

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~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Reporting on Program Milestones Anticipated upcoming news flow

  • Cholesterol-Lowering Anticipated completion of safety pharmacology Program and toxicology studies expected mid-CY2022

  • Mid-CY2022

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  • Phase I first in human studies to follow once preclinical studies are complete (to be run in Australia)

  • Brain Injury Program • Initial results from testing NYR-BI01 in WRAIR’s • Before end animal TBI model of CY2021

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  • Phase I first in human studies anticipated to • 2H CY2022 commence second half of 2022 (to be run in Australia)

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~~NYRADA INC (ASX:NYR)~~

~~AGM PRESENTATION~~

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Questions?

Brain Injury Solution Cholesterol-Lowering Animation Animation

@nyrada_inc

~~NYRADA INC (ASX:NYR)~~

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@nyrada_inc

ASX:NYR [email protected]

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www.nyrada.com

~~AGM PRESENTATION~~

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www.nyrada.com

~~NYRADA INC (ASX:NYR)~~

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~~AGM PRESENTATION~~