Nyrada, Inc. · ASX:NYR
Nyrada — Investor Presentation (June 2022)
28 slides from Nyrada's investor presentation, June 2022
Slide 1: Corporate Presentation
Improving Lives Through Innovation Corporate Presentation James Bonnar - CEO June 2022 ASX: NYR Authorised by Mr. John Moore, Non-Executive Chairman, on behalf of the Board. NYRADA INC (ASX:NYR) 1 CORPORATE PRESENTATION
Slide 2: Important Notice & Disclaimer
Important Notice & Disclaimer 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 shares in statements are
Slide 3: Portfolio of Novel High Value Small Molecule Drugs
Portfolio of Novel High Value Small Molecule Drugs 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 late CY2022 Oral PCSK9 inhibitor management Neurology Brai
Slide 4: Commercially Focused Business Model
Commercially Focused Business Model • 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 optimized drug candidates towards a key value inflection point of Objective confirming
Slide 5: Cholesterol-Lowering Drug Program
Cholesterol-Lowering Drug Program Novel small molecule PCSK9 Inhibitor
Slide 6: Cholesterol-Lowering Market
Cholesterol-Lowering Market Population, Problem, Opportunity 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 taking a statin1 Global
Slide 7: Current PCSK9 Injectable Drugs
Current PCSK9 Injectable Drugs Expensive and Inconvenient 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 • Patient convenience: once per day oral treatment C
Slide 8: Development of Drug Candidate NYX-PCSK9i
Development of Drug Candidate NYX-PCSK9i Discovery to Clinical Lead LDLR binding surface Target Product Profile (Difficult to drug) • Small molecule suitable for once per day oral dosing • Sufficiently potent in lowering LDL-C • Safety / toxicology profile consistent with chronic dosing • PCSK9 vali
Slide 9: Benchmarking Efficacy
Benchmarking Efficacy NYX-PCSK9i in Human Lymphocyte Cells • NYX-PCSK9i shows equivalency to Repatha® and Praluent® in human lymphocytes • LDLR retention confirmed with/without a statin, supporting NYX-PCSK9i use alone or in combination with statin - Mevastatin + Mevastatin % LDLR retention p-value
Slide 10: Benchmarking Efficacy
Benchmarking Efficacy NYX-PCSK9i +/- Lipitor® in Transgenic Mouse Hyperlipidemia Model 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 • APOE*3Leiden.CETP m
Slide 11: Program Milestones and Path to the Clinic
Program Milestones and Path to the Clinic 2H CY2020 1H CY2021 2H CY2021 UPCOMING JUL 2021 DEC 2021 CY 2022 DEC 2020 MAY 2021 USPTO Charles River Preclinical studies to commence NYX-PCSK9i shows Potent new drug grants patent for Laboratories in Q3 CY2022 57% reduction in total candidates Nyrada’s app
Slide 12: Phase I Study Design
Phase I Study Design OBJECTIVES • Evaluate safety, tolerability, and pharmacokinetics of NYX-PCSK9i • Measure changes in LDL cholesterol DESIGN • Double-blind, randomized, placebo-controlled, PARTICIPANTS dose escalation study • 56 healthy volunteers (18 to 50 years) • Single ascending oral dose (Co
Slide 13: Brain Injury Drug Program
Brain Injury Drug Program Novel small molecule TRPC 3/6/7 blocker
Slide 14: Brain Injury Market
Brain Injury Market Population, Problem, Opportunity Each year 5.3 million 800 thousand Americans suffer a stroke8 Each year Americans live with a post-TBI disability7 One drug class for stroke (tPA) 2.8 million suitable for >15% of patients Americans suffer a TBI6 Problem and Opportunity TBI Treatm
Slide 15: Brain Injury Trajectory, Patient Outcomes, Treatment Aims
Brain Injury Trajectory, Patient Outcomes, Treatment Aims 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. Data refer to people 16
Slide 16: TRPC 3/6/7 Ion Channels as a Therapeutic Target
TRPC 3/6/7 Ion Channels as a Therapeutic Target12 • Excessive glutamate release causes cell depolarization leading to Ca2+ buildup • Ca2+ entry via TRPC 3/6/7 ion channels is a major contributor to excitotoxicity • TRPC 3/6/7 channels expressed in neurons, astrocytes, platelets, vascular endothelial
Slide 17: Early Discovery Molecule shows Neuroprotection
Proof of Concept Early Discovery Molecule shows Neuroprotection NYX-104 shows Neuroprotection in a Photothrombotic Mouse Model • First generation molecule NYX-104 p < 0.01 p < 0.025 reduced Ca2+ entry via the TRPC ion channel (target upstream of TRPC Protection channel but unknown) Expansion from co
Slide 18: Proof of Concept
Proof of Concept Knockout Model shows Neuroprotection 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 mice have significantly b
Slide 19: Nyrada's Brain Injury Drug NYR-BI02
Nyrada’s Brain Injury Drug NYR-BI02 ADME-PK Profile Mean Plasma Concentration-Time Profile of NYR-BI02 in Mice NYR-BI02 advanced to efficacy studies IV-4.2 mg/kg, plasma in collaboration with WRAIR. IC50 • Nanomolar potent TRPC 3/6/7 blocker • Intact blood-brain barrier penetration (>50%) • ADME-PK
Slide 20: Program Milestones and Path to the Clinic
Program Milestones and Path to the Clinic 2H CY2020 CY2021 CY2022 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 the • New, m
Slide 21: Phase I Study Design
Phase I Study Design OBJECTIVES To assess the safety, tolerability, and pharmacokinetics of NYR-BI02 DESIGN • Randomized, double-blind placebo – PARTICIPANTS controlled, dose escalation design • Male and female healthy volunteers • 5 cohorts; 8 participants each cohort; • 18 – 50 years age 6:2 activ
Slide 22: Corporate Snapshot
Corporate Snapshot ASX:NYR NYRADA INC (ASX:NYR) 22 CORPORATE PRESENTATION
Slide 23: Corporate Snapshot
Corporate Snapshot Key Metrics Market capitalisation A$23.4M (US$16.9M) (as at 06 June 2022) Share price A$0.15 (US$0.11) (as at 06 June 2022) CDIs free float 156,008,700 Cash at bank 31 March 2022: A$11.3M (US$8.1M) • 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 Supported by specialist advisers: • Prof Gilles Lambert Cholesterol-lowering program • Prof Gary Housley Brain injury program • Dr Jim Palmer Medicinal Chemist James Bonnar - CEO Cameron Jones - CFO Dr Benny Evison - CSO • Business executive with 25 ye
Slide 25: International High Caliber Board
International High Caliber Board • Nyrada operates under the direction of a board of international caliber • Strong track record in finding and realizing the John Moore Dr Ian Dixon Peter Marks Non-Executive Chairman Non-Executive Director Non-Executive Director value of biotech companies • Experien
Slide 26: Summary
Summary 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-class treatment to pr
Slide 27: References
References 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-brai
Slide 28: ASX:NYR
Brain Injury Solution Cholesterol-Lowering Animation Animation @nyrada_inc @nyrada_inc ASX:NYR info@nyrada.com www.nyrada.com NYRADA INC (ASX:NYR) 28 CORPORATE PRESENTATION