Avecho Biotechnology Limited · ASX:AVE
Avecho Biotechnology — Investor Presentation (October 2023)
14 slides from Avecho Biotechnology's investor presentation, Oct 13, 2023
Slide 1: Phase III Shareholder Webinar
OCTOBER 2023 For personal use only PHASE III SHAREHOLDER WEBINAR www.avecho.com.au | ASX:AVE
Slide 2: 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 3: Agenda
AGENDA For personal use only 1. Capital Raise 2. Phase III trial design & timeline 3. Recent third-party results; implications for Avecho’s trial May 2022 3 AVECHO BIOTECHNOLOGY October 2023 3
Slide 4: Capital Raise
CAPITAL RAISE AVE Corporate Summary1 For personal use only Entitlement Offer – $2M Total shares (including T2) 3.17 Bn • 323M New Shares issued to existing shareholders, raising approximately $2M (May) Total options (including T2)2 2.37 Bn • Allowed Phase III manufacturing activities to commence Cas
Slide 5: Pharmaceutical Cannabidiol Is Valuable
PHARMACEUTICAL CANNABIDIOL IS VALUABLE Only one pharmaceutical CBD product is approved by the FDA (Epidiolex®)1 For personal use only • Epidiolex was developed by GW Pharma • Approved for rare childhood epilepsy conditions2 – rarely prescribed • GW Pharma was acquired for $7.2Bn USD by Jazz Pharma (
Slide 6: Insomnia in Australia – Unique CBD Opportunity
INSOMNIA IN AUSTRALIA – UNIQUE CBD OPPORTUNITY Insomnia can be broadly defined as difficulty initiating or maintaining sleep For personal use only The TGA allows CBD products to be registered as over-the- counter (OTC) medicines1 for indications such as insomnia OTC medicines are available direct fr
Slide 7: Scientific Advisors
SCIENTIFIC ADVISORS Assoc Professor Darren Mansfield Professor Shantha Rajaratnam Deputy Director, Monash Health Deputy Director, Turner Institute for Brain and For personal use only − Director Sleep Service, Monash Health Mental Health − Expertise across full range of sleep disorders, − Academic He
Slide 8: Phase III Study Design
PHASE III STUDY DESIGN Based upon study design from recently approved insomnia medications (Dayvigo, Quviviq) 2 weeks 8 weeks 2 weeks For personal use only Treatment A – Placebo before bed Screening Compliance Treatment B – 75 mg CBD before bed Follow-up period Check Treatment C – 150 mg CBD before
Slide 9: Timelines to Interim Analysis - Major Go/No Go
TIMELINES TO INTERIM ANALYSIS - MAJOR GO/NO GO 2023 2024 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec For personal use only Funding Activities Manufacturing Activities Clinical supply Registration batches Stability Phase III Trial Results Database b
Slide 10: The Danger of the Placebo Response
THE DANGER OF THE PLACEBO RESPONSE • A placebo effect is when a patient reports improvement in their condition after taking a For personal use only pretend (placebo) medicine Finalised trial • Trials with subjective endpoints design and (like insomnia) have high placebo effects timing will be • thei
Slide 11: First Clinical Trial Results
FIRST CLINICAL TRIAL RESULTS For personal use only Sources: 1. https://www.cannabiz.com.au/blow-for-cann-group-as-over-the-counter-cbd-trial-fails-to-show-efficacy-for-sleep-disturbance/ 2. https://www.cannabiz.com.au/were-not-giving-up-says-new-cann-group-ceo-as-researchers-pore-over-clinical-trial
Slide 12: Most Recent Trial Results – BOD
MOST RECENT TRIAL RESULTS – BOD On 6 September 2023 BOD Science Limited (ASX:BOD) announced Trial results of its study assessing CBD for insomnia. BOD tested two doses BOD 2 Avecho Parameters of CBD (50mg & 100mg) versus placebo in 208 patients over 8 weeks1 For personal use only 75mg CBD and 150mg
Slide 13: The Opportunity Open for Avecho
THE OPPORTUNITY OPEN FOR AVECHO • After four Australian companies pursued Phase IIb/III clinicals in insomnia targeting TGA registration, three have completed trials and failed to meet their primary endpoint For personal use only This leaves Avecho as the last company of the initial group in active
Slide 14: For personal use only
For personal use only Register interest in participating in our Phase III insomnia study at the following link; Questions welcome via our InvestorHub platform. cbdinsomniastudy.com
Avecho Biotechnology — Investor Presentation (October 2023) on 6ix