September 2026 Quarterly Activities Report & Appendix 4C
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
28 October 2026
Avecho Quarterly Activities Report and Appendix 4C
Key Highlights
Recruitment and dosing recommenced for the final stage of the pivotal Phase III insomnia
trial, following the positive interim analysis announced in June.
Approximately 320 additional participants are expected to be enrolled to achieve the originally
planned target of 519 participants completing the study, allowing for withdrawals.
Experienced international biopharmaceutical executive Eve Williamson appointed as a
strategic business development consultant to support international licensing and partnering
activities.
Licensing discussions with multiple parties for territories outside Australia continued to
advance.
Cash position of $5.3 million at 30 September 2026.
Melbourne, Australia, 28 October 2026: Avecho Biotechnology Limited (ASX: AVE) (“Avecho” or
“the Company”) is pleased to present its Quarterly Activities Report and Appendix 4C for the quarter
ended 30 September 2026.
Recruitment Recommences for Final Stage of Phase III Insomnia Trial
During the quarter, Avecho recommenced recruitment for the second and final patient cohort of its
pivotal Phase III clinical trial evaluating its TPM®-enhanced cannabidiol (CBD) soft-gel capsule for
the treatment of insomnia.
Recommencement of recruitment follows the positive interim analysis announced in June 2026, when
the independent Data Monitoring Board (DMB) unanimously recommended that the study proceed to
its originally planned size of 519 participants, without any increase in sample size.
At the interim analysis, the DMB assessed unblinded data from the first 244 participants and
confirmed that the study had satisfied the pre-specified criteria required to proceed. The
recommendation to continue at the original sample size indicates that the study is tracking at least in
line with the assumptions used in its design. Avecho remains blinded to treatment allocations and
efficacy results, which will not be available until the study has been completed and the final data
analysed.
Approximately 320 additional participants are expected to be enrolled in the second cohort to achieve
the target of 519 participants completing the study, including sufficient additional participants to
replace those who withdraw.
Recruitment has recommenced through Avecho’s existing clinical site network, with additional sites
being progressively activated to support and accelerate enrolment. The Company is applying the
recruitment strategies, patient management processes and operational improvements optimised
during the first stage of the study. Once the additional sites are operational, Avecho expects
recruitment of the remaining participants to be completed within approximately 12 months.
The multi-centre, randomised, double-blind, placebo-controlled study evaluates nightly doses of 75mg
CBD, 150mg CBD or placebo over an eight-week treatment period. Participants complete validated
questionnaires and daily sleep diaries to assess changes in insomnia severity and sleep quality.
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
The interim safety review identified no serious adverse events among the 244 participants assessed
across the three treatment groups. The safety and tolerability profile remains an important
component of the product’s potential commercial positioning.
Successful completion of the Phase III trial would represent the final clinical step supporting an
application to the Australian Therapeutic Goods Administration (TGA) for registration of the CBD
TPM® capsule for the management of insomnia.
Japanese Patent Strengthens International Intellectual Property Portfolio
In August, Avecho announced that a patent covering its proprietary TPM®-enhanced CBD capsule
had been granted in Japan.
The Japanese grant follows corresponding patents in the United States and Europe, providing
protection across three major pharmaceutical markets. The granted patents provide protection
through to 2043 in the United States and 2041 in Europe and Japan. Japan is the world’s third-largest
pharmaceutical market, and insomnia is highly prevalent there, with published studies estimating that
it affects around 13–14% of adults, or approximately 14 million people.
The Japanese patent strengthens Avecho’s intellectual property position around its lead product and
supports its international development, commercialisation and regional licensing strategy.
Corresponding patent applications remain under review across other key commercial territories.
Corporate Updates
Appointment of Strategic Business Development Consultant
In August, Avecho appointed experienced international biopharmaceutical executive Ms Eve
Williamson as a strategic business development consultant.
Ms Williamson brings more than 20 years of experience in pharmaceutical business development,
licensing, portfolio strategy and commercial leadership. Most recently, she served as Vice President,
Global Head of Business Development at CSL Limited, where she led the identification and evaluation
of strategic product opportunities across CSL’s vaccine and cardio-renal portfolios.
Her experience includes licensing and acquisition activities, multidisciplinary due diligence and
development of strategic partnering proposals. She has also held senior commercial and business
development positions with bio-CSL, Phebra and Hospira, with experience across Australia, North
America, Europe and Asia.
Ms Williamson will work closely with Avecho’s Chief Executive Officer and management team to lead
business development strategy, including identifying, evaluating and progressing licensing,
partnering, co-development and commercialisation opportunities for the CBD TPM® soft-gel capsule.
Her responsibilities also include assessing opportunities to unlock value across the Company’s broader
asset portfolio.
Business Development and Licensing Discussions
Following the interim analysis, Avecho has advanced licensing discussions with multiple
pharmaceutical companies for territories outside Australia, and these discussions continue to
progress. The appointment of Ms Williamson during the quarter has added dedicated senior capacity
to this process.
Avecho will also present at BIO-Europe in November 2026, where meetings with numerous
prospective partners are already scheduled.
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
Non-dilutive funding through licensing is the Company’s preferred means of funding the activation of
additional clinical sites to accelerate completion of the Phase III trial, and the Company is prioritising
these discussions accordingly. Licensing transactions of this kind are complex and their timing is not
within the Company’s sole control. While the Company is encouraged by the progress made, there is
no certainty that any transaction will be concluded, or as to its timing or terms. Avecho will keep the
market informed in accordance with its continuous disclosure obligations.
Avecho also continues to work with Sandoz on the activities required to support a future regulatory
submission to the TGA, and this work has gathered pace following the positive interim analysis.
Investor Engagement
Chief Executive Officer Dr Paul Gavin presented at the ASX SMIDcaps Conference on 23 September
2026. The presentation provided an update on the Phase III insomnia trial following the positive
interim analysis and recommencement of dosing. It also outlined the Company’s planned clinical,
manufacturing, regulatory and commercial activities over the following 12 to 18 months, including its
focus on international licensing opportunities.
Click here to view a replay of the presentation: https://www.youtube.com/watch?v=a3Fe-giZlsU
During and subsequent to the end of the quarter, Dr Gavin was also invited to participate in the
Monsoon Biotech Showcase, E&P Healthcare Conference, Canaccord Genuity Drug & Device
Conference and AusBiotech. At these events he presented to a range of institutional investors and
other market participants, in addition to conducting one-on-one meetings with selected fund
managers.
Cash Position
At 30 September 2026, Avecho held cash of $5.3 million, compared with $6.6 million at 30 June 2026.
Net cash used in operating activities during the quarter was $1.8 million.
Costs incurred during this period mainly related to the final stage of the Phase III clinical trial.
The Company received $477k under its R&D loan facility during the quarter, providing additional
funding pending receipt of its R&D tax incentive.
Payments to related parties and their associates during the quarter, as outlined in Section 6 of the
accompanying Appendix 4C, were $53,000. These payments relate to director fees.
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.
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
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
.
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.
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
5
Fresh Leaf Analytics, Australian Medicinal Cannabis Market, H1 2021
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
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.
Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 1
+ See chapter 19 of the ASX Listing Rules for defined terms.
Appendix 4C
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
AVECHO BIOTECHNOLOGY LIMITED
ABN Quarter ended (“current quarter”)
32 056 482 403 30 September 2026
Consolidated statement of cash flows Current quarter
$A’000
Year to date (9
months)
$A’000
1. Cash flows from operating activities
103 310
1.1 Receipts from customers
1.2 Payments for
(1,174) (2,446)
(a) research and development
(b) product manufacturing and operating
costs
(51) (84)
(c) advertising and marketing - -
(d) leased assets - -
(e) staff costs* (173) (557)
(f) administration and corporate costs
(g) patent portfolio costs
(424)
(54)
(889)
(138)
1.3 Dividends received (see note 3) - -
1.4 Interest received 5 11
1.5 Interest and other costs of finance paid (2) (6)
1.6 Income taxes paid - -
1.7 Government grants and tax incentives - -
1.8 Other (R&D tax incentive received) - 1,980
1.9 Net cash from / (used in) operating
activities
(1,770) (1,819)
*A percentage of staff costs are reallocated to payments for research and development, and product manufacturing and
operating costs.
2. Cash flows from investing activities
- -
2.1 Payments to acquire or for:
(a) entities
(b) businesses - -
(c) property, plant and equipment (22) (24)
(d) investments - -
(e) intellectual property - -
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 2
+ See chapter 19 of the ASX Listing Rules for defined terms.
Consolidated statement of cash flows Current quarter
$A’000
Year to date (9
months)
$A’000
(f) other non-current assets - -
2.2 Proceeds from disposal of:
- -
(a) entities
(b) businesses - -
(c) property, plant and equipment - -
(d) investments - -
(e) intellectual property - -
(f) other non-current assets - -
2.3 Cash flows from loans to other entities - -
2.4 Dividends received (see note 3) - -
2.5 Other (provide details if material) - -
2.6 Net cash from / (used in) investing
activities
(22) (24)
3. Cash flows from financing activities
- -
3.1 Proceeds from issues of equity securities
(excluding convertible debt securities)
3.2 Proceeds from issue of convertible debt
securities
- -
3.3 Proceeds from exercise of options - 2,104
3.4 Transaction costs related to issues of
equity securities or convertible debt
securities
- (21)
3.5 Proceeds from borrowings - -
3.6 Repayment of borrowings - -
3.7 Transaction costs related to loans and
borrowings
- -
3.8 Dividends paid - -
3.9(a) Other – Payment of principal element of
lease liabilities
(20) (60)
3.9(b)
3.9(c)
Others – R&D loan received
Others – R&D loan repayment (including
interest and fees)
477
-
2,056
(1,624)
3.10 Net cash from / (used in) financing
activities
457 2,455
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 3
+ See chapter 19 of the ASX Listing Rules for defined terms.
Consolidated statement of cash flows Current quarter
$A’000
Year to date (9
months)
$A’000
4. Net increase / (decrease) in cash and
cash equivalents for the period
6,610 4,663
4.1 Cash and cash equivalents at beginning of
period
4.2 Net cash from / (used in) operating
activities (item 1.9 above)
(1,770) (1,819)
4.3 Net cash from / (used in) investing activities
(item 2.6 above) (22) (24)
4.4 Net cash from / (used in) financing activities
(item 3.10 above)
457 2,455
4.5 Effect of movement in exchange rates on
cash held
- -
4.6 Cash and cash equivalents at end of
period
5,275 5,275
5. Reconciliation of cash and cash
equivalents
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
Current quarter
$A’000
Previous quarter
$A’000
5.1 Bank balances 5,275 6,610
5.2 Call deposits - -
5.3 Bank overdrafts - -
5.4 Other (provide details) - -
5.5 Cash and cash equivalents at end of
quarter (should equal item 4.6 above)
5,275 6,610
6. Payments to related parties of the entity and their
associates
Current quarter
$A'000
6.1 Aggregate amount of payments to related parties and their
associates included in item 1
(53)
6.2 Aggregate amount of payments to related parties and their
associates included in item 2
-
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an
explanation for, such payments.
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 4
+ See chapter 19 of the ASX Listing Rules for defined terms.
7. Financing facilities
Note: the term “facility’ includes all forms of financing
arrangements available to the entity.
Add notes as necessary for an understanding of the
sources of finance available to the entity.
Total facility
amount at quarter
end
$A’000
Amount drawn at
quarter end
$A’000
7.1 Loan facilities - -
7.2 Credit standby arrangements - -
7.3 Other (please specify) - -
7.4 Total financing facilities - -
7.5 Unused financing facilities available at quarter end -
7.6 Include in the box below a description of each facility above, including the lender, interest
rate, maturity date and whether it is secured or unsecured. If any additional financing
facilities have been entered into or are proposed to be entered into after quarter end,
include a note providing details of those facilities as well.
N/A
8. Estimated cash available for future operating activities $A’000
8.1 Net cash from / (used in) operating activities (item 1.9) (1,770)
8.2 Cash and cash equivalents at quarter end (item 4.6) 5,275
8.3 Unused finance facilities available at quarter end (item 7.5) -
8.4 Total available funding (item 8.2 + item 8.3) 5,275
8.5 Estimated quarters of funding available (item 8.4 divided by
item 8.1)
2.98
Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as “N/A”. Otherwise, a
figure for the estimated quarters of funding available must be included in item 8.5.
8.6 If item 8.5 is less than 2 quarters, please provide answers to the following questions:
8.6.1 Does the entity expect that it will continue to have the current level of net operating
cash flows for the time being and, if not, why not?
Answer: N/A
8.6.2 Has the entity taken any steps, or does it propose to take any steps, to raise further
cash to fund its operations and, if so, what are those steps and how likely does it
believe that they will be successful?
Answer: N/A
8.6.3 Does the entity expect to be able to continue its operations and to meet its business
objectives and, if so, on what basis?
Answer: N/A
Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered.
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ASX Listing Rules Appendix 4C (17/07/20) Page 5
+ See chapter 19 of the ASX Listing Rules for defined terms.
Compliance statement
1 This statement has been prepared in accordance with accounting standards and policies
which comply with Listing Rule 19.11A.
2 This statement gives a true and fair view of the matters disclosed.
Date: 28 October 2026
Authorised by: the Board of Avecho Biotechnology Limited
(Name of body or officer authorising release – see note 4)
Notes
1. This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the
entity’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An
entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is
encouraged to do so.
2. If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions
in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been
prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the
corresponding equivalent standard applies to this report.
3. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities,
depending on the accounting policy of the entity.
4. If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”.
If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the
[name of board committee – eg Audit and Risk Committee]”. If it has been authorised for release to the market by a
disclosure committee, you can insert here: “By the Disclosure Committee”.
5. If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as
complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and
Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial
records of the entity have been properly maintained, that this report complies with the appropriate accounting standards
and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a
sound system of risk management and internal control which is operating effectively.
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