Avecho Biotechnology Limited · ASX:AVE
Avecho Biotechnology — Shareholder Meeting (May 2023)
21 slides from Avecho Biotechnology's shareholder meeting presentation, May 23, 2023
Slide 1: ASX Announcement: Chair's Address & CEO Presentation
ASX Announcement 23 May 2023 Chair’s Address & CEO Presentation Melbourne, Australia, 23 May 2023 - Avecho Biotechnology Limited (ASX: AVE, “Avecho”, or “the Company”) attaches the Chair’s Address and the Chief Executive Officer’s Presentation for the Annual General Meeting of 23 May 2023 to be held
Slide 2: Chair's Address
Chair’s Address Dear Shareholders, I am pleased to share a Company update on behalf of Avecho Biotechnology Limited to coincide with our Annual General Meeting (“AGM”) today. This year has been important for the Company. We have completed all the necessary steps and built on our expertise in the cli
Slide 3: Chair's Address (continued)
The topical CBG TPM® formulation has already been earmarked for a subsequent Phase II clinical trial with the Lambert Initiative, with the trial documentation currently under development. Most recently, the Company has begun to develop THC gummies with TPM. These early prototypes are already generat
Slide 4: Annual General Meeting 23rd May 2023
ANNUAL GENERAL MEETING 23RD MAY 2023 For personal use only www.avecho.com.au | ASX:AVE
Slide 5: Safe Harbour Statement
SAFE HARBOUR STATEMENT AVECHO BIOTECHNOLOGY For personal use only This presentation, and any representations made before, during or after the presentation, may include forward- looking statements that are inherently subject to risks and uncertainties. These statements relate to, but are not limited
Slide 6: Clear Strategic Focus
CLEAR STRATEGIC FOCUS For personal use only 1. Develop, TGA register and commercialise a proprietary pharmaceutical CBD capsule containing TPM 2. License this and other TPM cannabinoid dosage forms in multiple indications, territories and markets May 2022 3 AVECHO BIOTECHNOLOGY May 2023 3
Slide 7: The Global Cannabis Market Is Already Huge
THE GLOBAL CANNABIS MARKET IS ALREADY HUGE Global Legal Cannabis Market For personal use only • Legal use (medicinal or adult) in 30 countries • Valued at $17.8 billion USD in 2021 • 65.0% of the market in North America in 2021 Despite the global value of the • Projected compound annual growth rate
Slide 8: Avecho's TPM Provides Commercial Differentiation
AVECHO’S TPM® PROVIDES COMMERCIAL DIFFERENTIATION Cannabinoids such as cannabidiol (CBD) are lipid For personal use only Increased oral CBD absorption soluble molecules with poor oral absorption (~6%) TPM increases absorption of lipids, including cannabinoids Increasing cannabinoid absorption produc
Slide 9: Pharmaceutical Cannabidiol Is Valuable
PHARMACEUTICAL CANNABIDIOL IS VALUABLE Only one pharmaceutical CBD product is approved by the FDA (Epidiolex ®) For personal use only • Epidiolex was developed by GW Pharma • Approved for rare childhood epilepsy conditions – rarely prescribed • GW Pharma was acquired for $7.2Bn USD by Jazz Pharma (2
Slide 10: CBD for the Treatment of Insomnia
CBD FOR THE TREATMENT OF INSOMNIA Insomnia is defined as difficulty initiating or maintaining sleep 40% of Australians getting less sleep than they For personal use only Growing body of prescribing information suggesting that CBD need may alleviate the symptoms of insomnia. 59.4% Experience symptoms
Slide 11: Unique Australian Opportunity
UNIQUE AUSTRALIAN OPPORTUNITY • The Australian Therapeutic Goods Association (TGA) has allowed pharmaceutical CBD products to be registered as over-the-counter (OTC) medicines. For personal use only • OTC medicines are available direct from a pharmacist without a prescription, a significant commerci
Slide 12: Clinical Trial Design Expertise Is Critical
CLINICAL TRIAL DESIGN EXPERTISE IS CRITICAL • A placebo effect is when a patient reports For personal use only improvement in their condition after taking a pretend (placebo) medicine Finalised trial • design Trials with subjective endpoints (likeand insomnia) have high placebo effects timing will b
Slide 13: Phase III Study Design
PHASE III STUDY DESIGN Based upon study design from FDA approved insomnia medications For personal use only Assessments include; Avecho’s Phase III insomnia trial has been • Daily sleep diary to record nightly sleep. designed to maximise the chance of success. • Sleep questionnaire every two weeks.
Slide 14: Phase III Trial Costs – Capital Raise
PHASE III TRIAL COSTS – CAPITAL RAISE For personal use only Cap Raise for ~$11M AUD* Chemistry, Manufacturing and Control (CMC) – (~$1.3M AUD) Two parts; • Entitlement Offer to Pivotal Phase III clinical trial – (~$11M AUD) Shareholders TOTAL • Placement of shortfall to • $~12.3M AUD new investors *
Slide 15: Capital Raise Progress
CAPITAL RAISE PROGRESS Entitlement offer – Existing Shareholders For personal use only • ~323M New Shares and ~486M New Options issued, raising approximately $2M • Interest for a further ~$1M in shortfall from existing sophisticated and institutional shareholders • ~$2M received is enough to commenc
Slide 16: Remaining Development Program (2023-24)
REMAINING DEVELOPMENT PROGRAM (2023-24) Chemistry, Manufacturing and Control (CMC) • Further CMOs engaged for access to other markets (complete) For personal use only • Manufacturing scale up to registration batch (1/10th commercial scale) size (ongoing) • Registration batches to be submitted for fo
Slide 17: New Partnerships
NEW PARTNERSHIPS Perrigo to develop AVE’s ibuprofen gel for US market For personal use only Athenex considering TPM injectables. Have taken Vitamin K TPM to FDA pre-IND Arthur Group to develop TPM oncology injectables Lambert to conduct two clinical trials with AVE’s CBD capsule. Also partnering on
Slide 18: Multiple Clinical Trials in 2023
MULTIPLE CLINICAL TRIALS IN 2023 Avecho products will be in multiple clinical trials in 2023, the majority funded by third parties. • Continuous news across multiple products and multiple indications For personal use only • Positive results from any of these studies will lead to compelling commercia
Slide 19: Company Snapshot (Mid Raise)
COMPANY SNAPSHOT (MID RAISE) Cash $0.924M1 Holdings by Top 20 Shareholders For personal use only + $0.627M (tax refund) + $2M (entitlement offer) 15.0% 52.4% As of 22nd May; 32.6% Shares 2,162M Market cap ~$12.9M Options 706M Top 10 Top 11-20 All others 1 As of 31 March 2023 May 2022 16 AVECHO BIOTE
Slide 20: Value Drivers
VALUE DRIVERS • Pivotal Phase III trial for an insomnia indication ready to go For personal use only • Ethics approval received, manufacturing activities commenced • CBD capsule targeting over-the-counter registration in Australia, followed by ROW • Huge potential commercial opportunity • Proprietar
Slide 21: Questions Welcome
QUESTIONS WELCOME For personal use only Dr Paul Gavin Chief Executive Officer T. +61 3 9002 5000 E. pgavin@avecho.com.au Melbourne Office Unit A8, 2A Westall Road Hallmarc Business Park Clayton VIC 3168 Australia T: +61 3 9002 5000 E: info@avecho.com.au
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