Nyrada, Inc. · ASX:NYR
Nyrada — Shareholder Meeting (November 2022)
26 slides from Nyrada's shareholder meeting presentation, Nov 21, 2022
Slide 1: Annual General Meeting Presentation
For personal use only 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 1 Chairman, on behalf of the Board. AGM PRESENTATION
Slide 2: Important Notice & Disclaimer
Important Notice & Disclaimer For personal use only This presentation has been prepared by Nyrada Inc (NYR or the Company). It should Although the Company believes that the expectations reflected in the forward-looking not be considered as an offer or invitation to subscribe for, or purchase any sha
Slide 3: Commercially Focused Business Model
Commercially Focused Business Model For personal use only • 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
Slide 4: Portfolio of Novel High Value Small Molecule Drugs
Portfolio of Novel High Value Small Molecule Drugs For personal use only Target Indication Aim Status Market (US) Cardiovascular Cholesterol Best-in-class small molecule drug to >18m Patients1 Phase I/IIa Study: NYX-PCSK9i Lowering disrupt and broaden the class in CV H1 CY2023 Oral PCSK9 inhibitor m
Slide 5: Cholesterol-Lowering Drug Program
For personal use only Cholesterol-Lowering Drug Program Novel small molecule PCSK9 Inhibitor
Slide 6: Cholesterol-Lowering Market
Cholesterol-Lowering Market Population, Problem, Opportunity For personal use only 56 million 18.4 million between ages 40 and 75 Unable to achieve treatment eligible LDL-C target despite taking a statin1 62.6 million 27.4 million 1 in 5 patients Americans have high cholesterol1 statin intolerant3 t
Slide 7: Current PCSK9 Injectable Drugs
Current PCSK9 Injectable Drugs Expensive and Inconvenient For personal use only 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: on
Slide 8: Benchmarking Efficacy
Benchmarking Efficacy NYX-PCSK9i +/- Lipitor® in Transgenic Mouse Hyperlipidemia Model For personal use only Study Objective: Results: Determine if additive reduction in total cholesterol can be • NYX-PCSK9i + Lipitor® achieves 65% total cholesterol achieved with combination statin therapy reduction
Slide 9: Efficacy in Model of Atherosclerosis
Efficacy in Model of Atherosclerosis NYX-PCSK9i in Human Tissue-Engineered Blood Vessel Model6 For personal use only Study Design Results: • Researchers at Duke University (US) used human stem cells • Optimised analog of NYX-PCSK9i reduced cell to create tissue-engineered blood vessels (TEBVs), adh
Slide 10: Phase I/IIa Study Design
Phase I/IIa Study Design For personal use only 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 acti
Slide 11: Acceleration of Clinical Program
Acceleration of Clinical Program For personal use only Accelerates Phase I modified Speeds transition Scale-up drug Combined Phase efficacy to include high to Phase IIb and manufacture I/IIa study to start assessment in cholesterol IND Application completed H1 CY2023 target patient patients with FDA
Slide 12: Program Milestones
Program Milestones For personal use only 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 candida
Slide 13: Brain Injury Drug Program
For personal use only Brain Injury Drug Program Novel small molecule TRPC 3/6/7 blocker
Slide 14: Brain Injury Market
Brain Injury Market Population, Problem, Opportunity For personal use only Each year 55 million +12.2 million suffer a stroke8 Each year People are living with the effects of medically treated TBI7 One drug class for stroke (tPA) ~5.5 million suitable for >15% of patients People suffer a severe TBI7
Slide 15: Brain Injury Trajectory, Patient Outcomes, Treatment Aims
Brain Injury Trajectory, Patient Outcomes, Treatment Aims For personal use only Primary Secondary Disability Injury Injury Level 5-Year Patient Outcomes following TBI11 30% 26% 22% 22% BECAME STAYED DIED WORSE IMPROVED THE SAME Data are US population estimates based on the TBIMS National Database. D
Slide 16: TRPC 3/6/7 Ion Channels as a Therapeutic Target
TRPC 3/6/7 Ion Channels as a Therapeutic Target12 For personal use only • Glutamate release following brain injury results in calcium entry via TRPC ion channels • Excessive calcium build-up leads to neuronal cell death • Blocking TRPC 3/6/7 ion channels is neuroprotective against secondary brain in
Slide 17: Proof of Concept
Proof of Concept Knockout Model shows Neuroprotection For personal use only TTC Staining Functional Improvement following Brain Injury in TRPC 3/6/7 KO Mice13 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 mic
Slide 18: Phase I Study Design
Phase I Study Design For personal use only OBJECTIVES To assess the safety, tolerability, and pharmacokinetics of NYR-BI02 DESIGN • Randomised, double-blind placebo – PARTICIPANTS controlled, dose escalation design • Male and female healthy volunteers • 5 cohorts; 8 participants each cohort; • 18 –
Slide 19: Program Milestones
Program Milestones For personal use only 2H CY2020 CY2021 CY2022 and Beyond MAR 2022 MAY 2022 FEB 2021 • NYR-BI02 • Provisional • Collaboration secured with selected for patent WRAIR and UNSW Sydney Phase I study application filed JUL 2020 JUN 2021 UPCOMING • Nyrada Brain Injury Data published at th
Slide 20: Targeting Non-Dilutive Funding
Targeting Non-Dilutive Funding Walter Reed Army Institute of Research (WRAIR) For personal use only • 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): • A
Slide 21: Corporate Snapshot
For personal use only Corporate Snapshot ASX:NYR NYRADA INC (ASX:NYR) 21 AGM PRESENTATION
Slide 22: Corporate Overview
Corporate Overview For personal use only 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: • Funded to pursue Phase clinical A$9.9M development in CY2023 ASX listing January 16, 2
Slide 23: Upcoming Newsflow
Upcoming Newsflow* For personal use only Cholesterol-Lowering Program Start of Phase I Study Phase I Study Read-outs from initial results Preclinical safety preclinical safety and Final results of and toxicology toxicology studies Phase I Study studies started Q4 H1 H2 H1 CY2022 CY2023 CY2023 CY2024
Slide 24: FY2022 Financial Performance
FY2022 Financial Performance For personal use only Highlights Operating Results Summary • Nyrada ended FY2022 with cash of $10.8M FY2022 (A$) FY2021 (A$) • Cash position as at the end of Q1 FY2023 was $9.9M R&D Costs 1,835,072 2,175,050 • R&D Tax Incentive refund of ~$1.2M received in Corporate and
Slide 25: References
References For personal use only 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.
Slide 26: For personal use only
For personal use only Brain Injury Solution Cholesterol-Lowering Animation Animation @nyrada_inc @nyrada_inc ASX:NYR info@nyrada.com www.nyrada.com NYRADA INC (ASX:NYR) 26 AGM PRESENTATION