Zelira Therapeutics Ltd. · ASX:ZLD
Zelira Therapeutics — Shareholder Meeting (November 2024)
12 slides from Zelira Therapeutics's shareholder meeting presentation, Nov 14, 2024
Slide 1: 2024 Annual Shareholders General Meeting Investor Briefing
ZELIRA THERAPEUTICS For personal use only 2024 Annual Shareholders General Meeting Investor Briefing 14 November 2024 ASX: ZLD OTCQB:ZLDAF zeliratx.com
Slide 2: Disclaimer & Important Notice
DISCLAIMER & IMPORTANT NOTICE Disclaimer Future Matters For personal use only 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: Overview of Zelira Therapeutics
Overview of Zelira Therapeutics For personal use only Global Markets Strategy Clinical Validation Focus Global Product Launch US, Australia, UK and EU footprint Leading pipeline of products in clinical Portfolio of branded, validated to rapidly access the largest, most development for insomnia, chro
Slide 4: FY24 Milestones
FY24 Milestones 2023 2024 17 Aug 23 8 Jan 24 First close of HOPE®-SPV funding Zelira’s HOPE® SPV receives US$819,000 US$3.25 million commitment, enabling the second tranche of funding initiation of HOPE® clinical trial For personal use only 15 Apr 24 Zelira receives $919,000 R&D Tax Incentive Scheme
Slide 5: Zelira's unique rapid commercialisation strategy
Zelira’s unique rapid commercialisation strategy For personal use only Launch Learn Develop Generate proprietary formulations Collect real-world patient data Patient data informs and de-risks design of clinical trial Launch products in global markets Refine product to meet patient needs Rapid path t
Slide 6: US FDA NDA Program: HOPE for irritability in PMS co-morbid with ASD
US FDA New Drug Approval (NDA) Program: HOPE® 1 for treatment of irritability in Phelan McDermid Syndrome (PMS) co-morbid with Autism Spectrum Disorder For personal use only Proprietary platform of Near-term development Clinically validated, highly cannabinoid medicine milestones de-risked ASD treat
Slide 7: Development pathway for HOPE Phelan McDermid Syndrome program
Development pathway for HOPE® 1 Phelan McDermid Syndrome (PMS) co-morbid with ASD program Phelan-McDermid Syndrome (PMS) Regulatory Pathway For personal use only Ultra-rare genetic condition caused by a deletion or change of Accelerated regulatory pathway strategy utilising existing pre- chromosome
Slide 8: ZYRAYDI (Enhanced Cannabinoid Capture and Dissolution Matrix)
ZYRAYDI™ (Enhanced Cannabinoid Capture and Dissolution Matrix) For personal use only DIFFICULTY WITH FORMULATION AND DEVELOPMENTS OF FREE FLOW CAP- CANNABINOID SULES AND TABLETS DUE TO NON • Breakthrough technology developed by Zelira DISTILLATE UNIFORMITY AND SEPARATING FROM POWDER BED • Solves the
Slide 9: Successful and positive FDA Pre-IND meeting
Successful and positive FDA Pre-IND meeting U.S. FDA responded quickly to Zelira’s Pre-IND meeting request, demonstrating the Agency’s engagement in advancing the HOPE® 1 Prompt FDA response For personal use only program Positive feedback on The FDA provided valuable guidance on the design of the IN
Slide 10: Full pathway to US-FDA in months
Full pathway to US-FDA in 36 months FDA - Orphan designation and IND opening 1 2 3 4 5 For personal use only TPP Pre-IND Phase 1/PK Phase II Factorial & Type C Meeting 4 - 6 months Dose Ranging 8 - 10 months Solidify target Preparation and PK study in healthy Phase II trial FDA Type C Meeting produc
Slide 11: HOPE development pathway for indications within ASD subset
HOPE® 1 and HOPE® 2 development pathway for indications within Autism Spectrum Disorder (ASD) subset Target Indication Subset Targets Co-morbid with ASD For personal use only 2024 2025 2026 2027 Initial focus IND and Phase 1/ Phase 2 Factorial Phase 3 Reduction in Irritability Phelan McDermid Syndro
Slide 12: 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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