Avecho to present at the ASX SMIDcaps Conference
Released
Released
Announcement PDF
Avecho Biotechnology Limited | ASX: AVE | ACN: 056 482 403 | ABN: 32 056 482 403
Unit 8A, 2A Westall Road, Hallmarc Business Park, Clayton VIC Australia 3168 avecho.com.au
ASX Announcement
23 September 2026
Avecho to present at the ASX SMIDcaps Conference
Melbourne, Australia, 23 September 2026: Avecho Biotechnology Limited (ASX: AVE) (“Avecho”
or “the Company”) is pleased to advise that CEO Dr Paul Gavin will present at the ASX SMIDcaps
Conference on Wednesday, 23 September 2026.
The Company’s presentation, which is attached to this announcement, provides an update on
Avecho’s Phase III CBD insomnia trial, which has passed the independent interim analysis, and
outlines the Company’s planned activities over the next 12 to 18 months.
For enquiries, please contact
Dr Paul Gavin
Chief Executive Officer
Avecho Biotechnology Limited
+61 3 9002 5000
This announcement has been authorised by the Board of Directors of Avecho Biotechnology Limited.
About Avecho
Avecho Biotechnology Limited develops and commercialises innovative Human and Animal Health
products using its proprietary drug delivery system called Tocopheryl Phosphate Mixture (TPM®
). TPM
is derived from Vitamin E using unique, proprietary and patented processes and is proven to enhance
the solubility and oral, dermal and transdermal absorption of drugs and nutrients.
Avecho’s lead asset is a proprietary cannabidiol (“CBD”) TPM soft-gel capsule demonstrated to increase
CBD absorption. The CBD soft-gel capsule is currently undergoing Phase III clinical development for
the treatment of insomnia.
See more here - avecho.com.au
About Insomnia
Insomnia is a sleep disorder defined as dissatisfaction with sleep quantity or quality associated with
difficulty initiating sleep, difficulty maintaining sleep and the inability to return to sleep on awakening.
It can manifest as a primary indication or be symptom of other disorders, including anxiety and
depression. Chronic insomnia is the most prevalent manifestation, characterised by insomnia symptoms
occurring at least three nights per week and for at least three months. Consequences of insomnia
include daytime sleepiness, poor memory function, decline in concentration with negative impacts on
social and work activities. Approximately 10-30% of the global population have symptoms of insomnia,
with 10-15% classified as chronic1
. Based on the current global population, up to 237M people are
affected by insomnia, with the sleep economy and sleep aids market estimated to reach US$950Bn by
20322
. In Australia, as many as ~60% of the population have at least some symptoms of insomnia
with a total cost to the Australian economy estimated to be A$19.1 billion3
. In August 2023, the
Australian Government issued a statement indicating that sleep health should be considered a national
priority as important as fitness and nutrition4
.
1
https://www.thegoodbody.com/insomnia-statistics/
2
https://finance.yahoo.com/news/sleep-economy-sleep-aids-market-133100851.html
3
https://www.deloitte.com/au/en/services/economics/analysis/rise-try-to-shine.html
4
https://www.health.gov.au/sites/default/files/2023-08/bedtime-reading-inquiry-into-sleep-health-awareness-in-australia.pdf
Avecho Biotechnology Limited | ASX: AVE | ACN: 056 482 403 | ABN: 32 056 482 403
Unit 8A, 2A Westall Road, Hallmarc Business Park, Clayton VIC Australia 3168 avecho.com.au
About Avecho’s Phase III Trial Program
The Company is currently conducting a pivotal (Phase III), multi-centre, randomized, double-blind,
placebo-controlled clinical trial evaluating the efficacy and safety of CBD TPM soft-gel capsules in adults
for use in the reduction of insomnia severity. The trial is the largest of its kind testing cannabidiol,
taking place at multiple sites around Australia. Aided by advice from international sleep and regulatory
experts, the trial has been designed to meet the requirements of the Australian Therapeutic Goods
Administration (“TGA”), US Food and Drug Agency and the European Medicines Agency. Trial
Participants will be randomly assigned to one of three groups to receive nightly doses of either 75mg
or 150mg of CBD, or a placebo for eight weeks. Participants will use validated questionnaires and daily
sleep diaries over the course of the study to record the duration and quality of their sleep.
Further information about the study can be found at ClinicalTrials.gov (Study Identifier: NCT05840822).
A successful Phase III trial is Avecho’s final clinical step in support of a submission to the TGA for
pharmaceutical registration of the CBD TPM soft-gel capsule for the management of insomnia. This
opportunity is particularly significant in Australia, where regulatory changes in 2020 allow for over-the-
counter sales of CBD products direct from pharmacy without a prescription, provided they gain
appropriate approvals. Avecho has an opportunity to be the first in this area as no other Phase III CBD
trials in Australia have succeeded. Initial projections estimated the Australian over-the-counter CBD
market would grow to over US$125M per annum5
.
Forward-Looking Statements
Certain statements in this announcement are forward looking statements. Forward-looking statements
can generally be identified by the use of words such as “anticipate”, “estimate”, “expect”, “project”,
“intend”, “plan”, “believe”, “target”, “may”, “assume” and words of similar import. These forward-
looking statements speak only as at the date of this announcement. These statements are based on
current expectations and beliefs and, by their nature, are subject to a number of known and unknown
risks and uncertainties that could cause the actual results, performances and achievements to differ
materially from any expected future results, performance or achievements expressed or implied by such
forward looking statements.
No representation, warranty or assurance (express or implied) is given or made by Avecho that the
forward-looking statements contained in this announcement are accurate, complete, reliable or
adequate or that they will be achieved or prove to be correct. Except for any statutory liability which
cannot be excluded, Avecho and its respective officers, employees and advisers expressly disclaim any
responsibility for the accuracy or completeness of the forward-looking statements and exclude all
liability whatsoever (including negligence) for any direct or indirect loss or damage which may be
suffered by any person as a consequence of any information in this announcement or any error or
omission therefrom.
Subject to any continuing obligation under applicable law or relevant listing rules of the ASX, Avecho
disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking
statements in these materials to reflect any change in expectations in relation to any forward-looking
statements or any change in events, conditions or circumstances on which any statement is based.
Nothing in these materials shall under any circumstances create an implication that there has been no
change in the affairs of Avecho since the date of the announcement.
Avecho’s major projects include delivering TPM enhanced injectable, oral and topical products for the
human health market, including the recently announced application of TPM to cannabinoids. The
Company is also developing TPM®
to enhance feed efficiency and health of livestock.
5
Fresh Leaf Analytics, Australian Medicinal Cannabis Market, H1 2021
Developing the first pharmaceutical
cannabidiol product for insomnia
www.avecho.com.au | ASX:AVE
ASX SMIDcaps Conference
September 2026
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 potential
applications for, Avecho’s TPM®
platform technology; (2) the
strength of Avecho‘s intellectual
property; (3) the timelines for
Avecho’s clinical trials and regulatory
processes for its different products;
(4) the scalability and efficiency of
manufacturing processes; (5)
revenue projections, market share
expectations, share price
expectations and capital
requirements.
Actual results may differ from the
expectations expressed in these
forward-looking statements, and the
differences may be material
(whether positive or negative).
The risks that may cause Avecho‘s
actual results, performance or
achievements to be materially
different from those expressed or
implied by such forward-looking
statements, include but are not
limited to: (1) risks inherent in the
development, approval and
commercialization of potential
products; (2) uncertainty of clinical
trial results or regulatory approvals
or clearances; (3) changes to
market trends or government laws
or regulations; (4) the potential
need for future capital; (5)
dependence upon collaborators; and
(6) protection of intellectual
property rights, among others.
Accordingly, you should not place
undue reliance on these forward-
looking statements.
Where Avecho sits today
https://avecho.com.au/wp-content/uploads/ave_euroz-hartleys_the-market-is-sleeping-on-this-one.pdf
Proprietary product
TPM-enhanced synthetic cannabidiol (CBD) capsule; IP protection to ~2043.
A registered pharmaceutical, not a medicinal-cannabis product.
De-risked in pivotal Phase III trial
Pivotal Phase III passed its independent interim analysis — the largest risk for
the study. Good safety profile. Dosing recommenced to conclude study.
Commercially validated
Sandoz — a global pharma major — licensed exclusive Australian rights after
extensive due diligence.
First-mover market
Australia's Schedule 3 pathway lets a registered CBD product sell through
pharmacies. No product registered yet – the market is open.
AVE CORPORATE SUMMARY
Shares on issue 3.86 Bn
Cash (end June 2026) A$6.6 M
Market capitalization1 A$81.14 M
Broker coverage Euroz Hartleys
C O M P A N Y S N A P S H O T
1. At COB 17th September, 2026
Insomnia is a major
problem worldwide1
>850 million
people have clinically
significant insomnia
of people across the world
experience insomnia symptoms
10-30%
Broadly defined as difficulty initiating or
maintaining sleep
Insomnia can be a symptom of a range of other
disorders, particularly mental health and psychiatric
disorders, and can contribute to their onset or
exacerbation.
$US 5.2 billion
Insomnia market worth
In 20242
Mental Health worth
$US 375 Bn3
1. https://www.thegoodbody.com/insomnia-statistics/
2. https://www.marketresearchfuture.com/reports/insomnia-market-545#:~:text=How%20much%20is%20the%20insomnia,forecast%20period%2C%202024%2D2032
3. https://finance.yahoo.com/news/532-billion-mental-health-market-144800771.html
EFFICACY · on track?
• By recommending continuation at the original sample size —
not a larger one — the independent Board signalled that
assumptions on effect size and variability are tracking at least in
line with expectation.
• The study was powered on the assumption the product
performs comparably to approved insomnia medicines.
Take-away performance to date is tracking in line with
approved insomnia medications.
SAFETY · is it tolerable?
Approved insomnia medicines carry real burdens:
• Overdose toxicity, next-day impairment, dependence & tolerance
CBD-TPM interim cohort — benign.
No serious adverse events reported across the 244 participants
dosed, at both dose levels.
Take-away safety profile to date is competitive with
approved sleep drugs.
T H E D E - R I S K I N G E V E N T
Pivotal Phase III Trial passed the interim analysis
UNANIMOUS Independent DMB recommends the trial continue to 519 patients — sample size unchanged
• A registered CBD medicine can sell over the counter in
Australia — through pharmacies, no prescription
• No such product is registered yet — the market is open to the
first mover
• 9.5 million Australians experience insomnia symptoms
• Australians spend ~A$5 billion a year on OTC medicines; initial
forecasts for OTC CBD exceed US$125 million a year1
• Exclusive Australian rights
• US$3M upfront — received on signing
• US$16M in development milestones (pre-commercial)
• 14–19% tiered royalties on net sales
• Right of first refusal on ex-Australia territories
The Australian Opportunity
Sources:
1. Fresh Leaf Analytics, Australian Medicinal Cannabis Market, H1 2021
2. https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02920239-3A663194&v=undefined
Licensed to Sandoz – Key Terms2
Australia – First Mover Market
The first deal is always the hardest. Focus now on licensing the CBD capsule in larger global markets
T H E P L A N F R O M H E R E
Completing the trial — and the value ahead
~320
patients to complete
(includes spares)
~10 sites
identified & ready
~12 months
to trial completion
(once all sites open)
H2 2026 Recommence Trial
• Recommence dosing - Activate additional sites
• Pursue ex-Australia licensing deal(s)
• Commence engagement with overseas regulators (e.g. FDA, EMA)
• Manufacturing scale-up continues
2027 Complete Trial
• Pursue further licensing deals
• Complete Phase III dosing to the final patient
• Complete manufacturing work required for TGA submission
• Compile TGA submission dossier
• Develop product with partners in international territories
(specific territories may have their own requirements)
Take-away: A de-risked asset, operationally executing a pivotal Phase III, already partnered with further commercial deals ahead —
the next 12–18 months is a sequence of value inflections for shareholders.
8
Every part of our thesis has been independently validated
For years we have claimed big things for this product. At each step, an external body has validated those predictions. One piece of validation remained.
Preclinical
validated that
TPM Increased
CBD absorption
US, EU & Japan
Patent Office
validated that
Product is unique
TGA
validated that
Trial design &
submission
strategy are
sound
Sandoz
validated that
Data, trial
design,
commercial case
are compelling
Market
validated that
Story is good,
value will follow
Interim analysis
validated that
Effect tracking in
line with
expectations
June 2026
C L O S I N G A R G U M E N T
Questions Welcome
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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