Nyrada, Inc. · ASX:NYR
Nyrada — E&P Small Caps Health Care Conference 2022
27 slides from Nyrada's conference presentation, Sep 5, 2022
Slide 1: Presentation to E&P Small Caps Health Care Conference
5 September 2022 Sydney, Australia For personal use only Presentation to E&P Small Caps Health Care Conference Nyrada Inc (ASX: NYR) is pleased to provide shareholders and the market generally with the attached presentation that will be given by Nyrada CEO, James Bonnar, at the E&P Small Caps Health
Slide 2: Forward-Looking Statements
Forward-Looking Statements For personal use only This announcement may contain forward-looking statements. You can identify these statements by the fact they use words such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “pr
Slide 3: Improving Lives Through Innovation – Corporate Presentation
For personal use only Improving Lives Through Innovation Corporate Presentation James Bonnar - CEO September 2022 ASX: NYR NYRADA INC (ASX:NYR) Authorised by Mr. John Moore, Non-Executive 1 Chairman, on behalf of the Board. CORPORATE PRESENTATION
Slide 4: 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 5: 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 Study: NYX-PCSK9i lowering disrupt and broaden the class in CV H1 CY2023 Oral PCSK9 inhibitor manag
Slide 6: Commercially Focused Business Model
Commercially Focused Business Model For personal use only • Novel small molecule treatments for serious and life-threatening diseases Focus Area where there is unmet clinical need and large market share potential Development • Advance optimised drug candidates towards a key value inflection point of
Slide 7: Cholesterol-Lowering Drug Program
For personal use only Cholesterol-Lowering Drug Program Novel small molecule PCSK9 Inhibitor
Slide 8: 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 9: 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 10: Development of Drug Candidate NYX-PCSK9i
Development of Drug Candidate NYX-PCSK9i Discovery to Clinical Lead For personal use only Target Product Profile PCSK9 Protein LDLR binding surface • Small molecule suitable for once per day oral dosing (Difficult to drug) • Sufficiently potent in lowering LDL-C • Safety / toxicology profile consist
Slide 11: 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 achieved with combination statin therapy cholesterol reduction
Slide 12: 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 13: Program Milestones and Path to the Clinic
Program Milestones and Path to the Clinic For personal use only 2H CY2020 1H CY2021 2H CY2021 UPCOMING JUL 2021 DEC 2021 CY2022 - CY2023 DEC 2020 MAY 2021 USPTO Charles River Preclinical studies to commence NYX-PCSK9i shows Potent new drug grants patent for Laboratories in H2 CY2022 57% reduction in
Slide 14: Phase I Study Design
Phase I Study Design For personal use only OBJECTIVES • Evaluate safety, tolerability, and pharmacokinetics of NYX-PCSK9i • Measure changes in LDL-cholesterol DESIGN • Double-blind, randomised, placebo-controlled, PARTICIPANTS dose escalation study • 56 healthy volunteers (18 to 50 years) • Single a
Slide 15: Brain Injury Drug Program
For personal use only Brain Injury Drug Program Novel small molecule TRPC 3/6/7 blocker
Slide 16: 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 17: 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 18: 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 19: 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 20: Program Milestones and Path to the Clinic
Program Milestones and Path to the Clinic For personal use only 2H CY2020 CY2021 CY2022 – CY2023 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
Slide 21: 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 22: Corporate Snapshot
For personal use only Corporate Snapshot ASX:NYR NYRADA INC (ASX:NYR) 20 CORPORATE PRESENTATION
Slide 23: Corporate Snapshot
Corporate Snapshot For personal use only Key Metrics Market capitalisation A$24.2M (as at 2 September 2022) Share price A$0.155 (as at 02 September 2022) CDIs free float 156,008,700 Cash at bank 30 June 2022: A$10.8M • Adequate funding for Phase I studies ASX listing January 16, 2020 NYRADA INC (ASX
Slide 24: Management Team with Proven Industry Experience
Management Team with Proven Industry Experience For personal use only High calibre Board with proven track record in realising the value of biotech companies: • John Moore Chairman • Christopher Cox Non-Executive Director James Bonnar - CEO Cameron Jones - CFO Dr Benny Evison - CSO • Marcus Frampton
Slide 25: Summary
Summary For personal use only Best-in-class small molecule PCSK9 inhibitor • Oral, once per day dosing, patient convenience • Manufacturing and cost advantages over biologics and peptides • Can be administered with a statin to achieve additive therapeutic effect (monotherapy or combination) First-in
Slide 26: 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 27: 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) 25 CORPORATE PRESENTATION