Chair's Address and CEO Presentation
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
26 May 2026
Chair’s Address & CEO Presentation
Melbourne, Australia, 26 May 2026: 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 26 May 2026 to be held at Grant Thornton Offices, Collins Square, Tower 5, Level
22, 727 Collins Street, Melbourne VIC 3008 at 1.00pm (AEST).
For enquiries, please contact
Naomi Lawrie
Company Secretary
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
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
Chair’s Address
Dear Shareholders,
I am pleased to welcome you to the 2026 Annual General Meeting of Avecho Biotechnology Limited.
When we met at last year's AGM, the Company had recently completed the licensing of the Australian
commercial rights for our TPM®-enhanced cannabidiol soft-gel capsule to Sandoz. At that time, I noted
the significance of partnering with a company of Sandoz's scale and expertise.
The twelve months since have been a period of steady execution against the program that partnership
made possible, alongside meaningful progress in the Company's corporate and financial position.
Corporate and financial position
The Company completed a $2.5 million placement in October 2025. This was followed by the receipt of
approximately $1.9 million from the expiry of the AVEOA options earlier this month, with a further R&D
tax credit anticipated in due course. Together, these provide the Company with a pro-forma cash
position of approximately A$6.6 million.
Our story has successfully caught the attention of new stockbroking and wealth management firms, in
additional to new institutional investors that we have welcomed to the register. As a result, Avecho's
market capitalisation has increased from $12.7 million at the last AGM to approximately $50 million
today.
Clinical execution
At the centre of the Company's activity is the Phase III clinical trial of our lead product in chronic
insomnia, conducted with the support of Sandoz.
Recruitment for the interim analysis closed ahead of target, with 244 patients randomised against an
original interim threshold of 210. The Company has also appointed an independent Data Monitoring
Board, which will oversee the interim analysis. Paul will speak in detail to the trial itself shortly.
The interim analysis is expected in late June. It is the next defined step in a program that has been
developed over several years, and the Company approaches it having completed the work it set out to
complete in advance of the read-out — operationally, financially, and in terms of the partnerships and
oversight now in place.
We will allow the data to speak for itself.
Conclusion and handover
On behalf of the Board, I would like to thank the entire Avecho team for their work over the past year,
and you, our shareholders, for your continued support as the Company approaches this next step.
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
I would also like to take the opportunity to thank Matt McNamara, who has made the decision to step
down from the Board after six years of service. Matt has been an important part of the Company during
the foundational development period of our CBD product, in addition to chairing our risk and audit
committees. We wish him well in his next endeavours.
I will now hand over to our Chief Executive Officer, Dr Paul Gavin, who will speak to the upcoming
read-out, the possible outcomes from the Data Monitoring Board, and the Company's plans for the
second half of 2026.
Thank you.
Dr Gregory Collier
Chairman of Avecho Biotechnology Limited
CEO Presentation
Tuesday 26th May 2026
www.avecho.com.au | ASX:AVE
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.
Coming into the Phase III interim analysis
Treatment Phase Complete Phase III insomnia trial
244 patients completed for the interim analysis — readout
late June 2026.
Significant Commercial Partner in place
Sandoz, world's largest generics pharma — US$3M upfront,
US$16M in milestones, 14–19% tiered royalties.
Active discussions with parties for additional territories.
Money in the bank
Proforma cash position of $6.6M , provides strong position
to execute deals following a positive interim readout
The market is starting to listen
Market cap ~4× since the 2025 AGM; Euroz Hartleys
initiated unsolicited research coverage.
The interim analysis arrives in five weeks. I'll spend today talking through how we got here and what comes next
W H E R E A V E C H O S I T S T O D A Y
Clear registration pathway with the TGA
Unique Australian OTC pathway for CBD; trial designed
and conducted for TGA submission.
Significant commercial potential in Australia
9.5M Australians experience insomnia; addressable market
potential >US$125M per annum.
Advancing every functional area of the business
Corporate
● $2.5M placement October 2025
● AVEOA options exercised May 2026 — $1.9M cash
● $2.0M R&D tax credit Q2 — pro-forma cash ~A$6.6M
● Capital structure simplified — options expired
Investor relations
● Market cap up ~4× since last AGM (~$12.7M → ~$49.8M)
● Active investor roadshows and engagement program
● Larger institutional investors joining the register
● Euroz Hartleys initiated independent research coverage
Business development
● Sandoz global team actively engaged on the program
● Active licensing discussions for ex-Australian territories
with additional parties
● Licensing discussions well progressed, expected post
interim outcome
Research & development
● 244 patients randomised — 16% above interim target
● Recruitment rate doubled vs 2024
● Independent Data Monitoring Board commenced Feb 2026
● US patent granted — protection to 2043 (EU in allowance)
T H E Y E A R B E H I N D U S
We closed recruitment ahead of target
244 patients randomised
16% above the 210-patient
interim analysis target
2×
randomisation rate
in 2025 vs 2024 — protocol
amendments and new sites
delivered
What the over-recruitment means
Greater statistical power
More patients means the interim analysis assesses efficacy from a more
robust dataset than the protocol originally required.
Strict inclusion criteria maintained
Additional patients met the same rigorous eligibility requirements — no
shortcuts to hit the number.
Recruitment momentum at closure
A surge of eligible patients in the closing weeks delivered the over-target
outcome
P H A S E I I I R E C R U I T M E N T
The market is listening
P H A S E I I I R E C R U I T M E N T
The result of telling a consistent story
~4× re-rate since the 2025 AGM | ~$12.7M → ~$49.8M
Active institutional engagement programme
● Multiple investor roadshows in 2025–26
● New institutional investors on the register
● Capital structure simplified post option expiry
● All eyes are on the June result
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Market
capitalisation
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US patent granted; European patent in allowance
US protection to 2043 • EU grant expected to follow • Covers proprietary cannabinoid soft-gel formulation
Coverage protects Avecho's proprietary cannabidiol soft-gel formulation — the combination of TPM, cannabinoid and lipid that makes the
product unique — in two of the world's largest pharmaceutical markets.
Importantly, the patents extend beyond CBD to formulations incorporating other cannabinoids, opening optionality for future products on
the same platform.
Strengthens ex-Australia
licensing
International licensing discussions
reinforced by demonstrable IP
protection in two of the largest
pharmaceutical markets
US grant secured
USPTO has granted the patent —
formal protection in place to 2043
Extends Avecho's moat
Avecho's TPM IP is a competitive
moat that prevents the future launch
of generic copies
I N T E L L E C T U A L P R O P E R T Y
US patent granted — protection to 2043
12 months on
Australian commercial rights signed
March 2025
US$3M upfront received
US$16M in development milestones
14–19% tiered royalties on net sales
10-year development and licensing
agreement
Right of first refusal for ex-Australian
rights
Twelve months in — a deeper partnership than the
paper
Team and resourcing
Our experience: Sandoz has
assigned a substantial team to the
program — broader than we
anticipated when the deal was
signed.
Working with the partner
Clinical, manufacturing and
regulatory conversations are now
active with Sandoz counterparts —
well beyond contract administration.
Commercial readiness
Sandoz brings an Australian field
sales team, pharmacy
relationships, and national
distribution — infrastructure that
activates on TGA approval.
Strategic option on ex-
Australia
Sandoz holds a right of first
refusal over territories outside
Australia — shaping our parallel
global licensing conversations.
Twelve months in, we view the partnership as materially
deeper than the contract on paper.
Management and Board
Company Snapshot
AVE Corporate Summary
Total shares 3.83 Bn
Total options1 0.16 Bn
Cash (end Q1 2026)
+ Options Exercised (May)
+ R&D tax credits Q2 2026
Proforma Cash
A$4.3 M
$1.9M
$2.0M
$6.6M
52 week high/low
MCAP2
0.3c – 1.4c
A$49.79 M
1 Staff LTI plan
2 As of May 22nd 2026
Top 20 Shareholders = 35.53%
Dr Paul Gavin Chief Executive Officer
Dr Roksan Libinaki Chief Operating Officer
Dr Greg Collier Chairman
Dr Ross Murdoch Non-Executive Director
Ms Kathy Connell Non-Executive Director
Ms Naomi Lawrie Company Secretary
FIVE WEEKS AWAY
T H E I N T E R I M A N A L Y S I S
244 participants randomised for the interim cohort
3 arms 75mg CBD | 150mg CBD | placebo
8 weeks of nightly dosing per participant
2 endpoints Insomnia Severity Index (ISI) + subjective sleep efficiency (sSE)
Blinded patients, investigators and Avecho all blinded to allocation
Insomnia —
what we're treating
Difficulty falling or staying asleep
Affects ~10-30% of Australians
No approved OTC pharmaceutical
product currently available in Australia
for ongoing use
Australia's unique Schedule 3 OTC
pathway for CBD opens a first-mover
commercial opportunity
2
T H E T R I A L
Phase III design — what we're testing
Largest CBD insomnia trial globally; designed to support a TGA submission on positive completion.
What the interim analysis is
1
What gets tested
The interim analysis examines whether the CBD
TPM® capsule is improving sleep in the 244
patients dosed to date — measured using two
independent primary endpoints (ISI and sSE).
Either endpoint succeeding is sufficient.
2
Who decides
An independent Data Monitoring Board reviews
the unblinded data. The DMB is independent of
Avecho and the trial investigators. Avecho
remains fully blinded throughout the process.
3
What we'll learn
The DMB will recommend one of three outcomes:
1) Positive - Continue the trial with a second
cohort of patients - confirmed sample size
2) Positive - Stop the trial for efficacy
3) Negative - stop the trial for futility
We acknowledge the interim analysis represents a binary outcome for the insomnia program —
and we approach it with realistic, evidence-based confidence in the trial's design.
U N D E R S T A N D I N G T H E R E A D O U T
3
From recruitment closed to interim result
2 March 2026
Recruitment
closed
May 2026
Dosing complete
(244 patients,
8 week treatment)
May 2026
Database locked,
statistical analysis
commences
4
June 2026
DMB conducts
data review
5
Late June 2026
DMB delivers
findings to Avecho
★
Late June 2026
Avecho announces
result to ASX
Independent Data Monitoring Board (DMB)
• External sleep, safety and biostatistical experts
• Independent of Avecho and trial investigators
• Met first time February 2026 to confirm charter and process
Avecho, trial sites and trial investigators remain fully blinded throughout. The DMB is the sole body with access to unblinded
interim data -- standard best practice for pivotal placebo-controlled trials.
P R O C E S S T O R E A D O U T
4
Why this trial is positioned to deliver a clinical signal
Three key design features have been built into this trial specifically to maximise the probability of a successful result
01
Two independent primary endpoints
1) Insomnia Severity Index (ISI)
2) Subjective Sleep Efficiency (sSE)
Only one needs to work for trial success.
02
Adaptive design interim analysis
The interim analysis can recalibrate the
trial, adjusting the required patient
numbers during the study to ensure the
result is conclusive.
03
Placebo-effect control mechanisms
The protocol is designed to minimise
damage from the placebo response —
improving the chance that genuine drug
effect is detected cleanly.
Supporting design features
150mg
Maximum allowed OTC
dose tested
519
Largest CBD insomnia
trial globally
8 weeks
Treatment duration per
patient
ISI ≥ 15
Tight inclusion criteria
FDA + EMA
Trial designed to global
standards
T R I A L D E S I G N
5
Three possible outcomes
Stop for efficacy -- positive
Upside scenario — not expected, but
possible
The drug/trial is working so well results
are highly statistically significant after
244 patients. The DMB can recommend
stopping the trial early, declaring Phase
III successful.
Stop for futility -- negative
The drug is not showing the
required effect
Dosing of further patients ceases —
preserving shareholder capital. The CBD
asset retains commercial value for
alternative indications.
The expected positive result is continuing the trial to 519 patients.
Stop-for-efficacy is upside, not the expectation.
W H A T H A P P E N S A F T E R T H E R E A D O U T
Trial continues -- positive
Base case positive outcome — this
is what we are aiming for
The drug/trial is working, with an
observable difference between treatment
and placebo. DMB recommends
continuing the trial with a confirmed
sample size needed to reach statistical
significance at completion.
6
Continuing the trial — how we fund it, how we execute
The base case requires ~300 additional patients. The two questions shareholders will ask: how much, and how long?
How we fund it
● Priority: pharmaceutical licensing
deal for an ex-Australian territory —
upfront fees from licensing would
fund Phase III completion.
● Capital raise as an alternative – but
plenty of time to focus on deals
● Decision driven by what's in
Avecho’s/shareholders' best
interests at the time
How we accelerate
● ~300 additional patients required
to complete the trial
● Plan to open ~10 additional clinical
sites — already identified
● With additional sites engaged,
recruitment expected to take ~12
months
● Lessons from interim recruitment
fully embedded in completion plan
What runs in parallel
● TGA dossier construction (with
Sandoz)
● Manufacturing scale-up continues
— funded from earlier placement
● Further ex-Australia licensing
conversations progress to closure
● Engagement with international
regulators (e.g. FDA) for global
pathway optionality
B A S E C A S E I N D E T A I L
Next 12 months — milestones and triggers
Now → Late June 2026
Interim analysis readout
● Dosing complete; database locked
● Statistical analysis
● DMB data review
● Formal DMB meeting - results
● Avecho announces result to ASX
H2 2026
Post-readout activation
● Pursue further licensing deals
● Open additional trial sites and
recommence dosing
● Potential engagement with overseas
regulators (e.g. FDA)
● Manufacturing scale-up continues
2027
Trial completion and submission
readiness
● Complete Phase III dosing to final
patient
● Complete manufacturing work
required for TGA submission
● Compile and finalise TGA submission
dossier
● Continue international partner
development
A S S U M I N G S U C C E S S
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 remains.
Preclinical
validated that
TPM Increased
CBD absorption
US 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
Product works
for the indication
June 2026
The next piece of validation arrives in June
17
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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