Zelira Therapeutics Ltd. · ASX:ZLD
Zelira Therapeutics — Investor Presentation (February 2023)
15 slides from Zelira Therapeutics's investor presentation, Feb 22, 2023
Slide 1: Zelira secures US$8.6M cornerstone funding for HOPE 1 US FDA clinical trials
For personal use only ZELIRA THERAPEUTICS Zelira secures US $8.6M cornerstone funding for HOPE® 1 US FDA clinical trials for Autism Spectrum Disorder (ASD) Investor Briefing February 2023 ASX: ZLD OTCQB:ZLDAF zeliratx.com
Slide 2: Disclaimer & Important Notice
DISCLAIMER & IMPORTANT NOTICE For personal use only Disclaimer Future Matters This presentation has been prepared by Zelira affairs, financial position or prospects of the Company. This presentation contains reference to certain intentions, Therapeutics Ltd ACN 103 782 378 (“Company”). It The Compan
Slide 3: Zelira's Unique Rapid Commercialisation Strategy – Key to Success
ZELIRA’S UNIQUE RAPID COMMERCIALISATION STRATEGY – KEY TO SUCCESS For personal use only Launch Generate proprietary formulations Launch products in global markets Rapid path to revenues Low Capex model Learn Collect real-world patient data Refine product to meet patient needs Real-time response to m
Slide 4: Background on Autism Spectrum Disorder (ASD)
Background on Autism Spectrum Disorder (ASD) For personal use only Prevalence • About 1 in 44 children have been identified with autism spectrum disorder (ASD) according to estimates from CDC’s Autism and Developmental Disabilities Monitoring (ADDM) Network • The CDC estimates that 5,437,988 (2.21%)
Slide 5: HOPE - Real World Evidence
HOPE® - Real World Evidence For personal use only Autism patients report HOPE® Grows For Autism improvement in symptoms video showing a before and quality of life with and after experience on Zelira Therapeutics’ HOPE® cannabinoid medication Launch & Learn Video of Australian Autism Spectrum Disorde
Slide 6: Zelira sponsored – HOPE Longitudinal, Real-world Data Study
Zelira sponsored – HOPE® 1 Longitudinal, Real-world Data Study For personal use only Clinical Global Impression (CGI) Global Improvement and Efficacy scores Improvements in CGI Global were of Emerald HOPE® patients observed with generally increasing improvements the CGI Global Improvement longer the
Slide 7: HOPE For US FDA Clinical Trials
HOPE® 1 For US FDA Clinical Trials For personal use only HOPE® launched in Over 9 Million doses All sales in the US are Proprietary HOPE® 1 product Pennsylvania in 2020 of HOPE® dispensed out of pocket payments currently on the market as and subsequently in Pennsylvania by parents that buy a tinctur
Slide 8: Enhanced Distillate Capture and Dissolution Matrix (EDCDM)
Enhanced Distillate Capture and Dissolution Matrix (EDCDM) For personal use only DIFFICULTY WITH FORMULATION AND DEVELOPMENTS OF FREE FLOW Distillate into CANNABINOID POWDER-BASED CAPSULES AND TABLETS DUE TO NON-UNIFORMITY capsules and PROBLEM DISTILLATE AND SEPARATING FROM POWDER BED tablets, R GLO
Slide 9: Pathway to US FDA NDA
Pathway to US FDA NDA For personal use only 1 2 3 4 5 TPP Pre-IND & IND Opening Phase II POC Type C Solidify Target ODD Successful Proof-of-Concept Meeting Product Profile Application opening of IND Phase II Trial Preparation and Commencement FDA Type C submission of Meeting Pre-IND & ODD post-Ph II
Slide 10: Summary of Strategy and Timeline
Summary of Strategy and Timeline For personal use only 2023 2024 2025 2026 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Duration SEPT SEPT SEPT SEPT MAR MAR MAR MAR NOV NOV NOV NOV MAY MAY MAY MAY AUG AUG AUG AUG OCT OCT OCT OCT DEC DEC DEC DEC APR APR APR APR JUN JUN JUN JUN JAN JAN JAN JAN FEB
Slide 11: SPV Structure
SPV Structure Binding term sheet from Cantheon Capital LLC (Cantheon) to provide an initial US $8.6M cornerstone funding for Zelira to conduct FDA For personal use only Phase 2 and Phase 3 clinical trials for Zelira’s proprietary and patented protected HOPE® 1 product (Term Sheet), via a special pur
Slide 12: iNGENū
iNGENū For personal use only Globally focused Contract Research Organization working exclusively in the cannabinoid and psychedelic space. Zelira HOPE® 1 SPV has appointed iNGENū CRO Pty Ltd (iNGENū) as its Contract Research Organisation (CRO) to lead the clinical validation and regulatory registrat
Slide 13: Zelira's Portfolio of Clinically Validated Assets
ZELIRA’S PORTFOLIO OF CLINICALLY VALIDATED ASSETS For personal use only Autism Insomnia Oral Care Dermatology Neuropathy Targeted Pain Platform PRODUCT HOPE® ZENIVOL® SprinJene RAF FIVE™ ITURA™ Technology CBD ZYRADI™ (EDCDM) & Novel Encapsulation 2020 2020 2021 2021 2021 2021 2022 DATE OF IRB approv
Slide 14: Zelira Patent Portfolio
Zelira Patent Portfolio A significant distinction of the Zelira strategy 41 For personal use only patents granted is our investment in patent protection Therapeutic Area Granted/Allowed Under Prosecution/Examination Cancer compositions 8 13 Skin compositions 4 8 Sleep compositions 8 27 26 Cancer pro
Slide 15: Thank You
For personal use only Thank You Zelira Therapeutics Phone +1-484-630-0650 Email info@zeliratx.com zeliratx.com
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