Avecho Biotechnology Limited · ASX:AVE
Avecho Biotechnology — Investor Presentation (April 2023)
32 slides from Avecho Biotechnology's investor presentation, Apr 3, 2023
Slide 1: Entitlement Offer to Fund Pivotal Phase III Clinical Trial
APRIL 2023 ENTITLEMENT OFFER TO FUND PIVOTAL PHASE III CLINICAL TRIAL www.avecho.com.au | ASX:AVE
Slide 2: Disclaimer
DISCLAIMER This presentation is issued by Avecho Biotechnology Limited (ASX: AVE) (Avecho or the Company) in Parties do not make and do not purport to make any statement in this presentation and there is no statement relation to a pro rata non-renounceable entitlement offer of new fully paid ordinar
Slide 3: Fast Facts
FAST FACTS • Avecho is developing pharmaceutical cannabinoid products using TPM® delivery technology • First 75 mg CBD capsule completed with Catalent, USA (May 2021) • First human clinical trial (Phase I PK) completed (Dec 2021) – characterised absorption • Pivotal Phase III clinical trial ready to
Slide 4: Clear Strategic Focus
CLEAR STRATEGIC FOCUS 1. Complete Phase III clinical trial testing proprietary pharmaceutical CBD capsule containing TPM 2. Commercialise this, and other TPM cannabinoid products, in multiple markets May 2022 4 AVECHO BIOTECHNOLOGY April 2023 4
Slide 5: Cannabinoids as Medicine
CANNABINOIDS AS MEDICINE • Medicinal cannabis extracts are being legalized around the world • Some markets are allowing consumer and recreational uses • Unregistered medicinal cannabis products are being prescribed for a range of therapeutic indications • Normal R&D into formulation development has
Slide 6: The Problem with Cannabinoids
THE PROBLEM WITH CANNABINOIDS Cannabinoids have very poor oral bioavailability; only ~6% of ingested cannabinoids are absorbed This presents challenges for developing formulations that can deliver cannabinoids to the body efficiently Increasing cannabinoid bioavailability has become a focus for many
Slide 7: Avecho's TPM Provides a Solution
AVECHO’S TPM® PROVIDES A SOLUTION TPM is Avecho’s proprietary phosphorylated vitamin E product Propofol TPM® TPM encapsulates drug molecules to improve their: - solubility - stability - oral bioavailability - dermal/transdermal delivery TPM has an excellent safety profile making it ideal for drug re
Slide 8: Avecho's TPM Solubilizes Cannabinoids
AVECHO’S TPM SOLUBILIZES CANNABINOIDS Cannabidiol* Solubility Increased solubility with TPM leads to…. Increased CBD Solubility… Oral Increased oral absorption Topical Increased topical absorption With TPM Without TPM *Cannabidiol (CBD) is the main non-psychoactive cannabinoid in cannabis. May 2022
Slide 9: TPM Increases Oral Absorption of CBD
TPM INCREASES ORAL ABSORPTION OF CBD Total cannabidiol absorbed (AUC) in rats Cannabidiol absorption profile in dogs Rodent studies conducted at Bioneer:FARMA in Dog studies conducted at Labcorp in the UK Copenhagen ✓ Increases in AUC produced by TPM formulations ✓ Increases in AUC produced by TPM f
Slide 10: Cannabis Market Overview
CANNABIS MARKET OVERVIEW Global Legal Cannabis Market • Legal use permitted (adult or medical) in 30 countries • Valued at $17.8 billion USD in 2021 • North America accounted for the largest revenue share, 65.0% in 2021 Despite the global value of the • Projected compound annual growth rate (CAGR) o
Slide 11: Pharmaceutical Cannabidiol is Valuable
PHARMACEUTICAL CANNABIDIOL IS VALUABLE There is currently only one pharmaceutical CBD product approved by the FDA (Epidiolex) • Epidiolex® was developed by GW Pharma • It is approved by the FDA for rare childhood epilepsy conditions • GW Pharma was acquired for $7.2Bn USD by Jazz Pharma (2021) to ob
Slide 12: 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. • OTC medicines are available direct from a pharmacist without a prescription, a significant commercial advantage over the
Slide 13: Pharmaceutical CBD TPM Capsule Complete
PHARMACEUTICAL CBD TPM CAPSULE COMPLETE • Formulations developed by Avecho over the last 3 years; increase CBD absorption in animal models (rodent and dog) • Capsule design finalised at Catalent, USA (May 21) • 75 mg of ultra-pure, synthetic CBD (Purisys) per capsule • Product shows good pharmaceuti
Slide 14: CBD for the Treatment of Insomnia
CBD FOR THE TREATMENT OF INSOMNIA Insomnia can be broadly defined as difficulty initiating or maintaining sleep. 40% of Australians getting less sleep than they need Growing body of prescribing information suggesting that CBD may alleviate the symptoms of insomnia. 59.4% Experience symptoms 3-4 time
Slide 15: Clinical Trial Design Expertise is Critical
CLINICAL TRIAL DESIGN EXPERTISE IS CRITICAL • A placebo effect is when a patient reports 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 be • The placebo effect
Slide 16: Phase III Study Design
PHASE III STUDY DESIGN Based upon study design from FDA approved insomnia medications 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. Compared to recent stu
Slide 17: Remaining Development Program (2023-24)
REMAINING DEVELOPMENT PROGRAM (2023-24) Chemistry, Manufacturing and Control (CMC) • Further CMOs engaged for access to other markets (complete) • Manufacturing scale up to registration batch (1/10th commercial scale) size (ongoing) • Registration batches to be submitted for formal stability (Q2 202
Slide 18: Maximising Value from the CBD Product Development
MAXIMISING VALUE FROM THE CBD PRODUCT DEVELOPMENT REMAINING DEVELOPMENT TGA Commercialised CBD capsule Phase III registration by Partner (insomnia) for insomnia (ANZ) • While investing in insomnia, Avecho can license the CBD Further Licenses, product for different indications, territories of markets
Slide 19: Cannabinoid Deals Already Signed
CANNABINOID DEALS ALREADY SIGNED CBD capsule for arthritis • CBD capsule licensed (Dec 2021) for arthritis indication (osteo and rheumatoid arthritis), to Perland (Medterra Pharma) • Medterra are one of the most successful consumer CBD companies in the United States • Perland will pay for all develo
Slide 20: Further Product Portfolio
FURTHER PRODUCT PORTFOLIO
Slide 21: Portfolio of Differentiated Cannabinoid Products
PORTFOLIO OF DIFFERENTIATED CANNABINOID PRODUCTS Partner Phase II or Product Therapeutic (Geography) Preclinical Phase I Observation Phase III Marketed Area al Study CBD Capsule Sleep TBD (ANZ) CBD Capsule Further indications TBD CBD Capsule Arthritis Perland (ROW) CBD Topical Gel Osteoarthritis TBD
Slide 22: 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 • Positive results from any of these studies will lead to compelling commercial opportunities. Produ
Slide 23: Recent Pharma Deals
RECENT PHARMA DEALS Topical Ibuprofen TPM gel licensed to Perrigo for US market • Perrigo are a leading global consumer company, with brands including Vitamin K TPM® Herron, Nicotinell and OsteoEze • Perrigo to begin clinical development of Avecho’s topical ibuprofen gel for the US market in a pain
Slide 24: Key Value Drivers 2023
KEY VALUE DRIVERS 2023 • PHASE III INSOMNIA TRIAL using oral CBD capsule. Significant re-rate point for the company • Further PHASE II OSTEOARTHRITIS trial using topical CBD gel • Up to FIVE ADDITIONAL CLINICAL TRIALS funded by third parties using TPM products • Commercial PARTNERING/LICENSING oppor
Slide 25: Company Snapshot
COMPANY SNAPSHOT Holdings by Top 20 Shareholders Cash $1.47M1 8.58% As of 31st March; 57.46% 33.95% Shares 1,838M Market cap $16.54M Options 220.3M Top 10 Top 11-20 All others 1 As of 31 December 2022 May 2022 25 AVECHO BIOTECHNOLOGY April 2023 25
Slide 26: Avecho Management & Board
AVECHO MANAGEMENT & BOARD Dr Paul Gavin Dr Roksan Libinaki Melanie Leydin Chief Executive Officer Chief Operating Officer CFO & Company Secretary − 20+ yrs Avecho − 20+ yrs Avecho − 25+yrs accounting; 15+ yrs − Ex- AVE CSO − Exec MBA Co-Sec − Inventor TPM® platform − Co. Operations and clinical − In
Slide 27: The Entitlement Offer
THE ENTITLEMENT OFFER
Slide 28: Rights Issue Overview
RIGHTS ISSUE OVERVIEW Avecho is launching a non-renounceable entitlement offer to provide existing shareholders the opportunity to invest in driving next steps across our highly promising Phase III clinical program. • Under the entitlement offer, all eligible shareholders can subscribe for new AVE s
Slide 29: Use of Funds
USE OF FUNDS The Entitlement Offer will raise up to approximately $11 million AUD. Manufacturing – $1.3M AUD • GMP manufacture of CBD soft-gel capsule for use in Phase III clinical trials and registration batches for formal stability Phase III clinical trial - $9.35M AUD • Main study costs including
Slide 30: Risks
RISKS This section discloses some of the key risks attaching to an investment in Avecho. Before investing or increasing your investment in Avecho, you should consider whether this investment is suitable for you having regard to publicly available information and your personal circumstances and follo
Slide 31: Risks
RISKS Commercial risk The development and commercialisation of Avecho’s technology is subject to an inherent risk of failure, including the possibility that the products developed by Avecho may fail to demonstrate any material benefit or advancement in brain optimisation or mental health well being,
Slide 32: Questions Welcome
QUESTIONS WELCOME Dr Paul Gavin Chief Executive Officer T. +61 3 9002 5000 E. pgavin@avecho.com.au Avecho Investor Hub https://ave.freshamplify.com/welcome
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