공고 • Jun 29
Avecho Biotechnology Limited Continues Recruitment for Phase III Insomnia Program Following Positive Interim Analysis Avecho Biotechnology Limited has announced it will continue with recruitment for its world-first Phase III insomnia program following a positive interim analysis evaluating its TPM®-enhanced cannabidiol (CBD) capsule. The interim analysis represents a major value-inflection point for the program, reducing clinical development risk and providing a defined pathway toward completion of the pivotal study. The independent Data Monitoring Board (DMB) has completed its review of the unblinded interim analysis data from the pivotal Phase III clinical trial. The DMB is comprised of independent experts in sleep medicine, clinical safety and biostatistics and is the only body with access to unblinded trial data. The DMB has unanimously recommended the trial continue to the full planned enrolment of 519 participants. The recommendation is highly encouraging as it confirms the study has satisfied the pre-specified criteria established in the trial protocol to progress beyond the interim analysis and continue recruitment of a second patient cohort. The interim analysis was conducted on data from 244 participants randomised across three treatment groups receiving nightly doses of either 150mg CBD, 75mg CBD or placebo in a TPM®-enhanced capsule over an eight-week treatment period. Safety data reviewed at the interim analysis further supported the program, with no serious adverse events (SAEs) recorded across the 244 participants. Tolerability is central to the commercial rationale for the product. The Company is currently conducting a pivotal (Phase III), multi-centre, randomised, 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). In 2025, Avecho licensed Australian commercial rights to the CBD TPM capsule to Sandoz under an agreement that included a USD 3 million upfront payment, potential development and commercial milestones of up to USD 16 million and tiered royalties on future sales. The positive interim analysis strengthens Avecho's commercial position and adds momentum to ongoing licensing discussions covering territories outside Australia. The Company believes the interim outcome enhances the attractiveness of the program to potential commercial partners and strengthens the product's positioning against existing sleep medications. Accordingly, progressing additional regional licensing agreements will be a key strategic priority as Avecho seeks to fund continued development while maximising shareholder value. The Company will also now look to engage with the FDA and other international regulatory agencies to determine the path forward for the product in specific geographies. 공고 • Apr 25
Avecho Biotechnology Limited, Annual General Meeting, May 26, 2026 Avecho Biotechnology Limited, Annual General Meeting, May 26, 2026. Location: grant thornton, collins square, tower 5, level 22, 727 collins stree, melbourne, vic 3008 Australia 공고 • Oct 23
Avecho Biotechnology Limited has completed a Follow-on Equity Offering in the amount of AUD 2.5 million. Avecho Biotechnology Limited has completed a Follow-on Equity Offering in the amount of AUD 2.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 500,000,000
Price\Range: AUD 0.005
Discount Per Security: AUD 0.0003
Transaction Features: Subsequent Direct Listing 공고 • Apr 24
Avecho Biotechnology Limited, Annual General Meeting, May 27, 2025 Avecho Biotechnology Limited, Annual General Meeting, May 27, 2025. Location: grant thornton offices at collins square, tower 5, level 22, 727 collins street, melbourne Australia Reported Earnings • Aug 30
First half 2024 earnings released: AU$0.001 loss per share (vs AU$0.001 loss in 1H 2023) First half 2024 results: AU$0.001 loss per share (in line with 1H 2023). Net loss: AU$2.18m (loss widened 2.2% from 1H 2023). Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has fallen by 59% per year, which means it is significantly lagging earnings. Reported Earnings • Mar 01
Full year 2023 earnings released: AU$0.001 loss per share (vs AU$0.001 loss in FY 2022) Full year 2023 results: AU$0.001 loss per share (in line with FY 2022). Net loss: AU$3.44m (loss widened 47% from FY 2022). Over the last 3 years on average, earnings per share has increased by 6% per year but the company’s share price has fallen by 54% per year, which means it is significantly lagging earnings. 공고 • Mar 01
Avecho Biotechnology Limited, Annual General Meeting, May 30, 2024 Avecho Biotechnology Limited, Annual General Meeting, May 30, 2024. New Risk • Nov 24
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 72% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (105% average daily change). Earnings have declined by 6.8% per year over the past 5 years. Shareholders have been substantially diluted in the past year (72% increase in shares outstanding). Revenue is less than US$1m (AU$817k revenue, or US$539k). Market cap is less than US$10m (€7.63m market cap, or US$8.35m). 공고 • Nov 23
Avecho Biotechnology Limited has completed a Follow-on Equity Offering in the amount of AUD 6.04685 million. Avecho Biotechnology Limited has completed a Follow-on Equity Offering in the amount of AUD 6.04685 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 536,803,333
Price\Range: AUD 0.006
Discount Per Security: AUD 0.00036
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 471,004,997
Price\Range: AUD 0.006
Discount Per Security: AUD 0.00036
Transaction Features: Subsequent Direct Listing Reported Earnings • Sep 04
First half 2023 earnings released: AU$0.001 loss per share (vs AU$0 in 1H 2022) First half 2023 results: AU$0.001 loss per share (further deteriorated from AU$0 in 1H 2022). Revenue: AU$446.4k (down 41% from 1H 2022). Net loss: AU$2.13m (loss widened 174% from 1H 2022). Over the last 3 years on average, earnings per share has increased by 2% per year but the company’s share price has fallen by 21% per year, which means it is significantly lagging earnings. New Risk • Sep 01
New major risk - Revenue and earnings growth Earnings have declined by 6.8% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (91% average daily change). Earnings have declined by 6.8% per year over the past 5 years. Revenue is less than US$1m (AU$817k revenue, or US$527k). Market cap is less than US$10m (€7.75m market cap, or US$8.36m). Minor Risk Shareholders have been diluted in the past year (18% increase in shares outstanding). Reported Earnings • Mar 04
Full year 2022 earnings released: AU$0.001 loss per share (vs AU$0.002 loss in FY 2021) Full year 2022 results: AU$0.001 loss per share (improved from AU$0.002 loss in FY 2021). Revenue: AU$1.13m (up 42% from FY 2021). Net loss: AU$2.34m (loss narrowed 31% from FY 2021). Over the last 3 years on average, earnings per share has fallen by 23% per year but the company’s share price has increased by 71% per year, which means it is well ahead of earnings. 공고 • Jan 12
Athenex Submits Avecho's Phytonadione to FDA Pre-IND Avecho Biotechnology Limited announced that its TPM®-enhanced Vitamin K (phytonadione) injectable product has been presented to the FDA by Athenex Pharmaceutical Division, LLC in a pre- Investigational New Drug (pre-IND) meeting request. Phytonadione (Vitamin K1) injections are used to treat bleeding or clotting problems caused by Vitamin K deficiency, reactions to certain medications, or other medical conditions that lead tothinning of the blood. It is routinely administered to infants at birth as a prophylactic, providing protection against bleeding, and in 2021 the US had an overall adult and pediatric approximate market size of USD 87 million, with over 4.9 million units sold. Phytonadione is an insoluble oil that requiresformulation with an emulsifying agent in order to dissolve the drug in a formulation suitable for injection. These excipients are typically hydrogenated castor oil (Cremophor EL) or polysorbate, both of which are associated with adverse side effects when given by injection. In lieu of the adverse excipients traditionally used, Athenex has interest in commercialising Avecho's phytonadione formulation, that uses TPM® to dissolve and solubilise the drug. The FDA's feedback to the pre-IND submission will define the amount of development work remaining before a New Drug Application (NDA) for the product could be filed with the FDA for formal review. If the FDA response to the pre-IND submission is generally favorable, and the remaining development work is commercially feasible, the parties will proceed to a license and development agreement to complete the phytonadione product development work for the NDA submission to the US FDA and product commercialisation. The final commercial terms of a subsequent agreement will be determined once FDA feedback is received. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 2 non-independent directors. Independent Non-Executive Chairman Greg Collier was the last independent director to join the board, commencing their role in 2015. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 30
First half 2022 earnings released: EPS: AU$0 (vs AU$0.001 loss in 1H 2021) First half 2022 results: EPS: AU$0 (up from AU$0.001 loss in 1H 2021). Revenue: AU$758.2k (up 185% from 1H 2021). Net loss: AU$777.7k (loss narrowed 55% from 1H 2021). Over the last 3 years on average, earnings per share has fallen by 57% per year but the company’s share price has increased by 100% per year, which means it is well ahead of earnings. Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 2 non-independent directors. Independent Non-Executive Chairman Greg Collier was the last independent director to join the board, commencing their role in 2015. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Reported Earnings • Mar 01
Full year 2021 earnings: Revenues miss analyst expectations Full year 2021 results: Revenue: AU$793.6k (up 106% from FY 2020). Net loss: AU$3.42m (loss widened 30% from FY 2020). Revenue missed analyst estimates by 41%. Reported Earnings • Aug 29
First half 2021 earnings released: AU$0.001 loss per share (vs AU$0.001 loss in 1H 2020) First half 2021 results: Net loss: AU$1.74m (loss widened 99% from 1H 2020). Executive Departure • Jun 08
Non-Independent Non-Executive Director David Segal has left the company On the 31st of May, David Segal's tenure as Non-Independent Non-Executive Director ended after 5.0 years in the role. We don't have any record of a personal shareholding under David's name. David is the only executive to leave the company over the last 12 months. Reported Earnings • Mar 30
Full year 2020 earnings released: AU$0.002 loss per share (vs AU$0.001 profit in FY 2019) The company reported a poor full year result with weaker earnings, revenues and control over costs. Full year 2020 results: Revenue: AU$384.6k (down 91% from FY 2019). Net loss: AU$2.63m (down 410% from profit in FY 2019). Reported Earnings • Feb 28
Full year 2020 earnings released: AU$0.002 loss per share (vs AU$0.001 profit in FY 2019) The company reported a poor full year result with weaker earnings, revenues and control over costs. Full year 2020 results: Revenue: AU$384.6k (down 91% from FY 2019). Net loss: AU$2.63m (down 410% from profit in FY 2019).