Avecho Biotechnology Limited · ASX:AVE
Avecho Biotechnology — Shareholder Meeting (May 2022)
27 slides from Avecho Biotechnology's shareholder meeting presentation, May 30, 2022
Slide 1: Chair's Address & CEO Presentation
ASX Announcement 30 May 2022 Chair’s Address & CEO Presentation For personal use only Melbourne, Australia, 30 May 2022: 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 30
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 Company’s Annual General Meeting (AGM) today. For personal use only The last year has been defined by significant progress for our cannabinoid (CBD) programs. Our oral
Slide 3: Financial Outlook and Conclusion
Avecho’s work on cannabinoids continues to build value for the Company and these programs will remain the focus for our investment moving forward. We hope that the next year will see even further advancements. Financial Outlook Avecho has a secure balance sheet with sufficient resources to progress
Slide 4: Annual General Meeting 30th May 2022
ANNUAL GENERAL MEETING For personal use only 30TH MAY 2022 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: Fast Facts
FAST FACTS For personal use only • Building proprietary differentiated cannabinoid products with TPM® delivery technology • First 75 mg CBD capsule completed with Catalent, USA (May 2021) • Phase I PK study completed (Dec 2021) – characterised absorption • Australian Phase III trial for an insomnia
Slide 7: 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 4 AVECHO BIOTECHNOLOGY I May 2022 4
Slide 8: Legacy Programs
LEGACY PROGRAMS For personal use only HUMAN HEALTH ANIMAL HEALTH • AB Vista will not continue with TPM® • Multiple potential licensees undertaking due • AB Vista has its own internal product under diligence. development. • Multiple assets being considered • Study showed feeds containing TPM improve
Slide 9: Pharmaceutical CBD Capsule
For personal use only PHARMACEUTICAL CBD CAPSULE
Slide 10: Cannabinoids as Medicine
CANNABINOIDS AS MEDICINE For personal use only Medicinal cannabis extracts are being legalized around the world Some markets are also allowing consumer and recreational uses Unregistered medicinal cannabis products are being prescribed for a range of therapeutic indications. Normal R&D into formulat
Slide 11: The Problem with Cannabinoids
THE PROBLEM WITH CANNABINOIDS For personal use only Cannabinoids are oil soluble molecules with low solubility in water Oil soluble molecules have poor oral bioavailability, which is also true for cannabinoids (3-8% absorbed) This presents challenges for developing formulations that can deliver cann
Slide 12: Avecho's TPM Increases Cannabinoid Absorption
AVECHO’S TPM® INCREASES CANNABINOID ABSORPTION For personal use only CBD Solubility Increased oral absorption Increased topical absorption Increased CBD Solubility… With TPM Without TPM May 2022 9 AVECHO BIOTECHNOLOGY I May 2022 9
Slide 13: Pharmaceutical CBD TPM Capsule Complete
PHARMACEUTICAL CBD TPM CAPSULE COMPLETE For personal use only • Formulations developed over the last 2 years; increase CBD absorption in animal models • Capsule finalised at Catalent, USA (May 21) • 75 mg of ultra-pure, synthetic CBD (Purisys) per capsule • Product shows good stability (ongoing). •
Slide 14: Phase I Trial: Characterising CBD Absorption
PHASE I TRIAL: CHARACTERISING CBD ABSORPTION First Dose Second Dose For personal use only • Demonstrated single dose pharmacokinetic (PK) profiles of 75 mg and 150 mg oral CBD capsule - Primary objective • Demonstrated safety and tolerability, in addition to absorption of TPM - Secondary objectives
Slide 15: CBD for the Treatment of Insomnia
CBD FOR THE TREATMENT OF INSOMNIA For personal use only 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% Experi
Slide 16: Development Program (2022-23)
DEVELOPMENT PROGRAM (2022-23) For personal use only 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 stabi
Slide 17: Maximising Value from the CBD Product
MAXIMISING VALUE FROM THE CBD PRODUCT DEVELOPMENT For personal use only REMAINING DEVELOPMENT Global medical TGA Commercialise cannabis market CBD capsule Phase III (insomnia) registration d by Partner ~$7.8 Bn in 2020; for insomnia (ANZ) expected to be $30-50 Bn by 2027 Global cannabis market ~20 B
Slide 18: Cannabinoid Deals Already Signed
CANNABINOID DEALS ALREADY SIGNED For personal use only 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 w
Slide 19: New Dosage Forms
For personal use only NEW DOSAGE FORMS
Slide 20: Topical CBD TPM Gel: Phase II Osteoarthritis Trial
TOPICAL CBD TPM GEL: PHASE II OSTEOARTHRITIS TRIAL For personal use only Avecho has completed a Phase II clinical trial in collaboration with the Lambert Initiative testing a topical CBD gel in patients suffering osteoarthritis of the hand. • N=15 subjects applied a topical CBD gel to painful finger
Slide 21: Phase II: Topical CBD TPM Improves Pain and Grip Strength
PHASE II: TOPICAL CBD TPM IMPROVES PAIN AND GRIP STRENGTH For personal use only CHANGE OVER TIME 40% Baseline Active dosing period (30 days) • “Average Pain” significantly decreased over Treatment 30% Average Change from Baseline (%) stops the study period (p<0.001) 20% • “Maximum Pain” significantl
Slide 22: Growing Portfolio of Differentiated Cannabinoid Products
GROWING PORTFOLIO OF DIFFERENTIATED CANNABINOID PRODUCTS For personal use only 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
Slide 23: Company Overview
For personal use only COMPANY OVERVIEW
Slide 24: Company Snapshot
COMPANY SNAPSHOT For personal use only Holdings by Top 20 Shareholders Cash $2.44M1 R&D tax credit + $1M 8.0% As of 26th May; 56.4% 35.6% Shares 1,838M Market cap $31.2M Options/Performance Rights 217.3M Top 10 Top 11-20 All others 1 Quarter ending 31 March 2022 May 2022 21 AVECHO BIOTECHNOLOGY I Ma
Slide 25: Avecho Management & Board
AVECHO MANAGEMENT & BOARD For personal use only 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. Operat
Slide 26: News 2022
NEWS 2022 For personal use only • MANUFACTURING; complete scale-up of the CBD capsule, CMC dossier, registration batches • PHASE III INSOMNIA PROGRAM using oral CBD capsule; complete study design, initiate program for insomnia indication • Further PHASE II OSTEOARTHRITIS trial using topical gel • Co
Slide 27: 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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