Avecho Biotechnology Limited · ASX:AVE
Avecho Biotechnology — Shareholder Meeting (May 2021)
23 slides from Avecho Biotechnology's shareholder meeting presentation, May 31, 2021
Slide 1: Chair's Address & CEO Presentation
ASX Announcement 31 May 2021 ASX Market Announcements ASX Limited Level 4, North Tower, Rialto 525 Collins Street Melbourne VIC 3000 Chair’s Address & CEO Presentation Melbourne, Australia, 31 May 2021: Avecho Biotechnology Limited (ASX:AVE, “Avecho”, or “the Company”) attaches the Chair’s Address a
Slide 2: Dear Shareholders
Dear Shareholders, Before we enter into the formal business of the meeting, I would like to spend a few minutes reflecting on the progress and events of the year. This year, as our global community has navigated the public health challenges presented by COVID-19, the biotechnology sector has emerged
Slide 3: Year in review
The “fill formulation” encapsulated within the soft-gel is already being prescribed to patients in an observational study for patients undergoing therapy with medicinal cannabis. Exposure to patients in this study will be included in future TGA submissions to support the safety of the product, and w
Slide 4: Annual General Meeting
Annual General Meeting Monday, 31st May 2021 At 1:00pm www.avecho.com.au | ASX:AVE
Slide 5: Safe Harbour Statement
Safe Harbour Statement 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 to: (1) the safety or efficacy of, or poten
Slide 6: Year in review
i\vecho Year in review
Slide 7: Strategic Focus Presented June 2020
Strategic Focus Presented June 2020 Avecho has a clear, strategic focus to deliver on two fronts: Realise value from its portfolio of existing human Leverage its proprietary TPM® platform to develop and animal health assets new cannabinoid-based pharmaceuticals • Minimal investment going forward • T
Slide 8: Business Development – (Human Health Assets)
Business Development – (Human Health Assets) Engaged an external BD licensing firm (Simon Bennett and Associates; SBA) in July last year, to run an external business development and licensing campaign on the legacy human health products Outreach identified a number of companies with interest in vari
Slide 9: Business Development – (Animal Health Assets)
Business Development – (Animal Health Assets) TPM® has shown promise as an additive to feedstock: - improves feed efficiency for faster weight gain and stock turnover - improves meat quality and potential shelf life - can improve animal health and disease resistance - is a non-antibiotic alternative
Slide 10: 2020 Plan for developing TPM formulation of cannabinoids
2020 Plan for developing TPM® formulation of cannabinoids PROOF OF FORMULATION PRECLINICAL CLINICAL CONCEPT DEVELOPMENT STUDIES STUDIES COMPLETED IN PROGRESS LATE 2020 2021 Demonstrated that TPM® Initial formulations under Animal studies Human safety, can improve the solubility development in Denmar
Slide 11: TPM formulations increase oral bioavailability of CBD
TPM formulations increase oral bioavailability of CBD Research conducted at Bioneer:FARMA in Copenhagen Total CBD absorbed (AUC) Rats received a single oral dose of CBD and drug content measured in the blood over time. Absorption from TPM formulations compared against CBD in MCT (as sold to patients
Slide 12: 12 Month News flow communicated in June
12 Month News flow communicated in June Initial cannabinoid formulation development with TPM® Preclinical studies evaluating TPM® cannabinoids First-in-man studies using TPM®-formulated cannabinoids Disease-specific clinical trials using TPM®-cannabinoids Commercial licence or sale of one or more hu
Slide 13: Company Snapshot
Company Snapshot Shares 1,829M Avecho – YTD price and volume Market cap $31.1M ** * * * * * ** * ** 0.009 Options / Performance Rights 217.3M ** * * ** 0.008 0.007 Cash $5.74M1 0.006 0.005 0.004 Capital Raise $5.06M 0.003 0.002 230M new shares at 2.2c per share 0.001 Attached options 1:2, exercisabl
Slide 14: CBD soft-gel development
CBD soft-gel development Next 12 months
Slide 15: TGA Changes - Over-the-counter CBD
TGA Changes - Over-the-counter CBD In December 2020, the TGA advised that it would allow future CBD products to be registered as over-the- counter (S3) medicines. This would allow patients to buy CBD products directly from a pharmacy, without the need to consult a GP and get a prescription. However,
Slide 16: Oral Pharmaceutical CBD Soft-gel Product
Oral Pharmaceutical CBD Soft-gel Product • 75 mg CBD TPM soft-gel capsule developed at Catalent • Supports single dose or twice daily dosing under TGA S3 framework • Soft-gel capsules to be tested in Phase I PK study • Followed by pivotal Phase III study in Australia • Focusing on insomnia related S
Slide 17: Work required to support TGA registration
Work required to support TGA registration A registration dossier for product approval in Australia (and other territories) contains data related to the following categories; • Chemistry, manufacturing and controls (CMC) – can the finished product be manufactured reproducibly, to high pharmaceutical
Slide 18: Ongoing and planned development activities
Ongoing and planned development activities Regulatory • Development plan assembled for work required to register CBD soft-gel • TGA pre-submission meeting planned to validate development plans • Cannvalate/MCRC engaged to assemble pre-submission package. CMC • Catalent finalised development of initi
Slide 19: Broad timelines by activity
Broad timelines by activity Q1 2020 Q2 2020 Q3 2020 Q4 2020 H1 2021 H2 2021 Strategic Workshop TGA presubmission TGA Meeting (Cannvalate) package Regulatory Finalise clinical development plans TGA dosser assembly Submit? Develop/finalise CBD soft-gel product (Catalent) Pilot manufacturing run CMC Cl
Slide 20: Additional opportunities with third parties
Additional opportunities with third parties • Topical cannabinoid products; Interest in topical cannabinoid products from a growing number of companies/institutes. We have already shown TPM can increase the topical absorption of CBD. • Partnerships (academic and commercial); Providing TPM/cannabinoi
Slide 21: 12 Month News flow related to primary program
12 Month News flow related to primary program Results of TGA pre-submission meeting and resulting timelines Completion of US manufacturing program for soft-gel product Updates/Completion/Results of Phase I PK study Pivotal human study updates/conduct Commercial partnership, licencing deal (HH, AH, C
Slide 22: Questions
i\vecho Questions
Slide 23: Contact
Contact Dr Paul Gavin Chief Executive Officer +61 3 9002 5000 pgavin@avecho.com.au Melbourne Office Unit A8, 2A Westall Road Hallmarc Business Park Clayton VIC 3168 Australia Tel: +61 3 9002 5000 Email: info@avecho.com.au 20
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