Zelira Therapeutics Ltd. · ASX:ZLD
Zelira Therapeutics — Benzinga conference (May 2020)
27 slides from Zelira Therapeutics's conference presentation, May 2020
Slide 1: Zelira Therapeutics: A Leading Global Medicinal Cannabis Company
ZELIRA THERAPEUTICS A LEADING GLOBAL MEDICINAL CANNABIS COMPANY ASX: ZLD OTCQB: ZLDAF WWW.ZELIRATX.COM
Slide 2: Disclaimer & Important Notice
DISCLAIMER & IMPORTANT NOTICE Disclaimer This presentation has been prepared by Zelda Therapeutics Ltd ACN 103 782 378 (“Company”). It does not purport to contain all the information that a prospective investor may require in connection with any potential investment in the Company. You should not tr
Slide 3: Zelira Therapeutics
ZELIRA THERAPEUTICS • A publicly-listed biopharmaceutical company developing, and marketing clinically validated cannabis medicines • US, Australia and EU footprint to rapidly access the largest, most profitable & fastest growing cannabis markets • Leading pipeline of products in clinical developmen
Slide 4: Medicinal Cannabis: Accelerated Path to Market
MEDICINAL CANNABIS: ACCELERATED PATH TO MARKET Conventional Pharmaceutical Development Path 10 years to market, $1 Billion-expensive medicine Preclinical Clinical (Phase 1, 2 3) Registration Market Revenue starts $$ Emerging Market for Unregistered Cannabis Medicines Legal, safe & affordable, rapid
Slide 5: Zelira's Launch, Learn and Develop Model
ZELIRA’S “LAUNCH, LEARN AND DEVELOP” MODEL MARKET SURVEY TO IDENTIFY UNMET NEED HIGH QUALITY OBSERVATIONAL PATIENT DATA TRIALS LAUNCH & LEARN CLINICAL TRIALS PATIENT DATA FROM PATIENT RESPONSE DISPENSARIES TO PRODUCT 5
Slide 6: Differentiated Commercialization Model
DIFFERENTIATED COMMERCIALIZATION MODEL License or partner with leading Design key pre-clinical Value Adding and clinical studies Pharma/Biotech or distribution partner • Clinically validated Branding Attracts Revenues from Global • Proprietary formulations Price Premium Distribution/Licensing • GMP-
Slide 7: Zelira's Commercialization Strategy - USA
ZELIRA’S COMMERCIALIZATION STRATEGY - USA Access 4M patients1 Target MSO’s focused on medicinal cannabis Licensing (IP) • US$10BB market is >100X larger than Australia • Novel virtual distribution strategy to accelerate access to entire US market • HOPE™ Products licensed in PA and LA. • License pro
Slide 8: How Are We Different?
HOW ARE WE DIFFERENT? 8
Slide 9: Focus on Current Patient Needs = Large Addressable Market
FOCUS ON CURRENT PATIENT NEEDS = LARGE ADDRESSABLE MARKET Sleep Insomnia Anxiety Autism Pain Nausea Opioid Reduction Hope® Chronic Pain Inflammatory Skin Disorders Most common reasons patients use medicinal cannabis1. 1. Lintzeris, N et al., Medical Cannabis in Australia, 2016: the Cannabis as medic
Slide 10: Strong Intellectual Property Portfolio
STRONG INTELLECTUAL PROPERTY PORTFOLIO Patent Priority Date Filing • Seven patent families filed covering: Cancer August 2016 WO2018/023166 - Cancer* - Skin Disease (topical)* Skin Disease August 2016 WO2018/023164 - Sleep Disorders* Sleep Disorders August 2016 WO 2018/023163 - Cancer diagnostics* -
Slide 11: Strategic Focus on Disrupting Traditional Pharma Markets
STRATEGIC FOCUS ON DISRUPTING TRADITIONAL PHARMA MARKETS DIABETES ONCOLOGY PAIN ~US$330B TOTAL DRUG SPEND IN USA AUTSIM INSOMNIA Estimated annual cannabis substitution cost = $4.86 billion in 2019 (New Frontier Data1 ) Source: https://www.statista.com/statistics/238698/us-health-spending-leading-are
Slide 12: Dermatology Subsidiary
DERMATOLOGY SUBSIDIARY • Leverage the recognized brand and expertise of Karyn Grossman MD (Grossman Dermatology) to formulate and commercialize high quality, differentiated dermatology products for the dermatology subsidiary. • Dr. Grossman has 20% equity stake in the subsidiary. • Collaboration wil
Slide 13: Zelira's Diversified Revenue Model
ZELIRA’S DIVERSIFIED REVENUE MODEL LAUNCH & CLINICAL ORAL LEARN DERMATOLOGY HEALTH PHARMA TRIALS Autism Insomnia RX Toothpaste Pain Aged disorders Opioid Sparing Full Spec CBD Mouth Wash GI Autism OTC Consumer Brand 13
Slide 14: Efficacy of ZTL-101 for Treating Chronic Insomnia
EFFICACY OF ZELIRA’S MEDICINAL CANNABIS FORMULATION (ZTL-101) FOR TREATING CHRONIC INSOMNIA WORLD’S FIRST PHASE 1A/2B CLINICAL TRIAL TARGETING SLEEP DISORDERS 14
Slide 15: Key Insomnia Stats - USA Market
KEY INSOMNIA STATS-USA MARKET Insomnia is the most common sleep disorder in America 30% 83% Of people who suffer from depression also experience symptoms of insomnia. Adults have ~60m symptoms of Affected by insomnia Nearly 50% insomnia Of adults > 60 suffer from symptoms of insomnia. Up to 10% Adul
Slide 16: Zelira: Insomnia Phase 1a/2b Trial
ZELIRA: INSOMNIA PHASE 1A/2B TRIAL A Study to Evaluate the Efficacy of Sublingual Cannabinoid Based Medicine Extract (ZTL-101) Compared with Placebo for the Treatment of Sleep Disorders Due to Insomnia Investigational Team: PI - Prof Peter Eastwood, Clinical Prof David Hillman, Ass Prof Nigel McArdl
Slide 17: ZTL-101 Met Primary and Secondary Endpoints
ZTL-101 MET PRIMARY AND SECONDARY ENDPOINTS Primary Endpoints Secondary Endpoints Improved Objective and Subjective SAFE Measures of Insomnia • No serious adverse events Statistically significant improvement in: • Adverse events mild and transient • Time spent asleep • Maximal dose well tolerated •
Slide 18: Patient Comments
PATIENT COMMENTS * Person Placebo ZTL-101 “Fell asleep and did not wake up in middle “Has zero effect on any insomnia.” of night…more than in past 22 years.” “Even with double doses for this “I haven't slept this well in a very long arm, still not sleeping.” time.” “Stayed awake for hours trying to
Slide 19: ZTL-101 Comparable to Current Sleep Medications
ZTL-101 COMPARABLE TO CURRENT SLEEP MEDICATIONS Criteria Temazepam Zolpidem Suvorexant Melatonin ZTL-101 (Temtabs®) (Stilnox®/Ambian®) (Belsomra®) Aspen Sanofi Merck Rapid Sleep Onset +/- ✓ ✓ X X Improved Sleep ✓ +/- X ✓ X Maintenance Increase Total Sleep ✓ ✓ ✓ ✓ X Improve ‘Quality of Sleep’ ✓ ✓ ✓ X
Slide 20: Summary for ZTL-101
SUMMARY FOR ZTL-101 • First clinically validated medicinal cannabis drug targeting chronic insomnia • Phase 1b/2b clinical trial successfully achieved all primary and secondary endpoints • ZTL-101: safe and tolerable • ZLT-101 is efficacious: Patients slept longer, slept sooner after waking, spent m
Slide 21: Corporate
CORPORATE 21
Slide 22: Corporate Snapshot
CORPORATE SNAPSHOT FINANCIALS (as at 30 April 2020) SHARE PRICE (as at 30 April 2020) AUD$ • Share Price $0.046 • 52w Range $0.022 - 0.091 • Current shares on issue 966m • Market Capitalization $44m CAPITAL STRUCTURE (Fully Diluted2) • Cash (Mar 2020) $4.02m Structure Major Shareholders • Cash Burn
Slide 23: Comparative Analysis
COMPARATIVE ANALYSIS CONFIDENTIAL. FOR INTERNAL REVIEW ONLY. DO NOT DISTRIBUTE. Market Cap Market Cap Revenue Company Name to Revenue Product & Development Status (USD) (2019) Ratio Approved for Sativex (MS spasticity) and Epidolex® (childhood epilepsy), GW Pharmaceuticals $3.0BB $311M 9.1x multiple
Slide 24: Board of Directors
BOARD OF DIRECTORS Osagie Imasogie Harry Karelis Dr Richard Hopkins Dr Oludare Odumosu Jason Peterson Lisa Gray Chairman of the Board Vice Chairman of the board CEO & Managing Director CEO & Managing Director USA Director Director EX-US • Over 30 years in the field of law, • Co-founder corporate adv
Slide 25: Rich Product Pipeline Launching in 2020
RICH PRODUCT PIPELINE LAUNCHING IN 2020 Launch Market 1H 2020 2H 2020 Revenues Autism Launched Insomnia (ZTL-101) (2020) Aged Disorder (2020) Dermatology (2021) Targeted Pain/GI (2021) 25
Slide 26: Upcoming Milestones
UPCOMING MILESTONES • Clinical Trial Results o Phase II Insomnia Trial - Successfully achieved primary and secondary endpoints. o Phase Ib Opioid Sparing Trial (Reports 1H 2020). Fully recruited. • International launch of multiple proprietary products o HOPE™ Grows for Autism® (Launched in US, Q3 20
Slide 27: Zelira Offers Exposure to Emerging Global Industry
ZELIRA THERAPEUTICS OFFERS INVESTORS EXPOSURE TO A RAPIDLY EMERGING GLOBAL INDUSTRY AT VERY ATTRACTIVE VALUATIONS AND SIGNIFICANT VALUE DRIVERS OVER THE NEXT 3-18 MONTHS 27