Duyuru • 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. New Risk • Jun 25
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Australian stocks, typically moving 20% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Earnings have declined by 5.9% per year over the past 5 years. Revenue is less than US$1m (AU$1.2m revenue, or US$854k). Minor Risks Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (AU$80.4m market cap, or US$55.5m). Duyuru • 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 Reported Earnings • Mar 02
Full year 2025 earnings released: AU$0.001 loss per share (vs AU$0.001 loss in FY 2024) Full year 2025 results: AU$0.001 loss per share (in line with FY 2024). Revenue: AU$1.24m (up 9.3% from FY 2024). Net loss: AU$4.42m (loss widened 42% from FY 2024). Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has remained flat, which means it is significantly lagging earnings. New Risk • Nov 24
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 16% This is considered a minor 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 (22% average weekly change). Earnings have declined by 5.3% per year over the past 5 years. Revenue is less than US$1m (AU$1.4m revenue, or US$891k). Minor Risks Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (AU$25.7m market cap, or US$16.6m). Duyuru • 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 Reported Earnings • Aug 31
First half 2025 earnings released: AU$0.001 loss per share (vs AU$0.001 loss in 1H 2024) First half 2025 results: AU$0.001 loss per share (in line with 1H 2024). Revenue: AU$560.1k (up 79% from 1H 2024). Net loss: AU$2.68m (loss widened 23% from 1H 2024). 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 16% per year, which means it is significantly lagging earnings. Duyuru • 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 New Risk • Mar 28
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$15.8m (US$9.99m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$4.0m free cash flow). Share price has been highly volatile over the past 3 months (33% average weekly change). Earnings have declined by 15% per year over the past 5 years. Revenue is less than US$1m (AU$1.1m revenue, or US$714k). Market cap is less than US$10m (AU$15.8m market cap, or US$9.99m). Reported Earnings • Mar 01
Full year 2024 earnings released: AU$0.001 loss per share (vs AU$0.002 loss in FY 2023) Full year 2024 results: AU$0.001 loss per share (improved from AU$0.002 loss in FY 2023). Revenue: AU$1.13m (up 139% from FY 2023). Net loss: AU$3.12m (loss narrowed 9.2% from FY 2023). Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings. 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 44% 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 42% per year, which means it is significantly lagging earnings. Duyuru • 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 (35% average weekly 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$536k). Market cap is less than US$10m (AU$12.7m market cap, or US$8.32m). Duyuru • 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 05
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 7% per year, which means it is significantly lagging earnings. Reported Earnings • Mar 03
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 44% per year, which means it is well ahead of earnings. Duyuru • 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. Duyuru • Dec 24
Avecho Biotechnology Limited Receives Ethics Approval for its Pivotal Phase III Clinical Trial Testing its Oral CBD Softgel Capsule for Insomnia Avecho Biotechnology Limited announced it has received ethics approval for its pivotal Phase III clinical trial testing its oral CBD softgel capsule for insomnia. The study will be a multicenter study conducted in up to 10 sites around Australia. The lead site will be Monash Medical Centre in Melbourne, Australia under the supervision of Principal Investigator, Associate Professor Darren Mansfield, Deputy Director of Monash Health. The study will enrol 540 patients across three treatment groups to compare nightly CBD doses of 75 and 150 mg CBD with placebo over an 8 week dosing period. The study will have two primary endpoints: To investigate the effect of the administration of 75 mg and 150 mg per day CBD TPM® capsules versus placebo on reductions in insomnia severity after 8 weeks of treatment, as measured by the Insomnia Severity Index (ISI), and; To investigate the effect of the administration of 75 mg and 150 mg per day CBD TPM® capsules versus placebo on reductions in insomnia severity after 8 weeks of treatment, as measured by subjective sleep efficiency. Avecho has already established the single dose absorption profile from its softgel capsule, but blood will be collected across the 8 week study period to establish the steady state CBD concentrations after longer periods of dosing. The study will incorporate an interim analysis after roughly 300 patients have been dosed to conduct a powering and futility assessment. The powering calculation will be used to confirm the number of patients required to complete the study. The futility assessment will be used to determine whether there is any effect present in the study, or whether it should be terminated early. 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. Duyuru • Sep 19
Avecho Biotechnology Limited Announces Interim Results from Comparative Pharmacokinetic Studies Conducted in the Uk Avecho Biotechnology Limited announced interim results from comparative pharmacokinetic studies conducted in the UK, showing that Avecho's oral cannabidiol ("CBD") product under development has increased bioavailability compared to Epidiolex®, the only FDA approved CBD product. The current study characterized and compared the CBD absorption profile from single dose of (i) the Avecho TPM® CBD formulation, (ii) CBD dissolved in the simple oil vehicle (MCT), (iii) the commercial Epidiolex® formulation and (iv) a formulation with TPM® dissolved directly into the commercial Epidiolex® formulation (Epidiolex + TPM®). All test formulations were administered to fasted dogs via oral gavage and characterized over 24 hours. The average area-under-the-curve ("AUC") of the CBD absorption profile and peak plasma concentration (Cmax) were calculated for each formulation. AUC represents the amount of drug absorbed after administration and is used to compare relative drug absorption between treatments. Both AUC and Cmax are standard measurements used to characterise drug absorption. Study results: Avecho's clinical CBD TPM® formulation produced higher average AUC and Cmax than the CBD MCT control and the commercial Epidiolex® formulation. The Avecho CBD formulation increased average AUC by 4 and average Cmax 2.5 times when compared to Epidiolex®. The Epidiolex® + TPM® formulation increased average AUC by 4 times and average Cmax by 3 times when compared to Epidiolex®. No symptoms of gastro-intestinal ("GI") irritation were observed for the clinical Avecho CBD formulation or the Epidiolex® + TPM® formulation, despite the four-times increase in average CBD absorption. The study is ongoing and will now assess the absorption of these formulations when accompanied by a meal; a factor known to increase the absorption of CBD. While the increased bioavailability produced by formulations containing TPM® is important, it was equally significant that the increase in absorption from TPM® formulations did not produce any observable GI issues. Increasing the dose of CBD products, including Epidiolex®, can cause diarrhea and GI distress. This GI irritation can be prohibitive for indications requiring high doses of CBD, and industry has been looking for a way to increase the CBD dose without increasing the associated irritation. Dogs are an especially sensitive model for the assessment of GI irritation. No GI irritation was observed for the Avecho formulation or the Epidiolex + TPM® in dogs, despite the four-fold increase in CBD absorption. TPM® formulations may therefore be appropriate in the future for indications that require very high doses of CBD. The increased absorption of the Avecho CBD formulation versus controls has now reproduced across two independent animal models; rodent and dog. These results validate the Company's choice of formulation for use in human trials seeking low dose CBD approval, and gives the product maximal chance of success in the upcoming Phase III. 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 26% 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. Duyuru • Mar 29
Avecho Biotechnology Limited Announces Positive Results for Its Phase IIa Study Avecho Biotechnology Limited announced positive results for its Phase IIa Study (the Study) examining the effects of its topically applied CBD formulation on the symptoms of osteoarthritis (OA). The Study was run by Principal Investigator, Dr. Daniel Lewis, from the Daniel Lewis Rheumatology Centre; and Co-Investigator, Professor Iain McGregor, from the Lambert Initiative, Australia's leading research group for the discovery, development, and optimisation of safe cannabinoid therapeutics. Hand OA is a common, painful, progressive, and irreversible condition that significantly impairs hand strength and function. There are limited treatment options available and current therapies primarily involve symptom relief and preservation of function. Systemic administration of CBD has shown promise in animal models of OA, however, topical therapeutics are of particular interest in diseases such as OA due to their targeted application and avoidance of first-pass metabolism. Four week treatment with the company's proprietary topical CBD formulation resulted in highly significant improvements (p<0.001) in patient observed (i) reductions in pain, (ii) increases in grip strength, (iii) improvements in hand functionality, (iv) self-reported stiffness of the fingers and (v) self-reported anxiety. Phase IIa Study Clinical Trial Results: The single-centre proof-of-concept trial investigated the effects of a topical CBD gel on symptomatic, painful OA of the hand, affecting the fingers and/or thumb. A group of 15 patients applied the company's proprietary TPM® formulation daily to the affected joints of a single hand. The Study was run over a 6 week period, including 1 week of baseline measurements, 4 weeks of treatment, and a subsequent 1 week of washout after the conclusion of dosing. Participants were asked to complete a range of daily assessments. The primary outcome measure was the change from baseline in daily hand pain (average and maximum) as measured by the 10-point Numeric Pain Rating Scale (NPRS). The secondary objectives involved hand functionality including grip strength measured daily via an electronic squeeze ball dynamometer connected via Bluetooth to a smartphone-based recording app, and the Functional Index for Hand Osteoarthritis (FIHOA) score, completed at baseline and weekly until study exit. The reduction in pain scores was highly significant (p<.001) for both the average daily NPRS pain scores (1.32-point difference, baseline = 4.38,) and maximum daily NPRS pain scores (1.62-point difference, baseline = 5.57). Improvements in grip strength and functionality were also highly significant (p<0.001) with functionality measurements (relative to the baseline) in the treated hand markedly improving during the first week of treatment and being maintained over the 4-week dosing period. Most participants also saw improvements in functional index for hand osteoarthritis (FIHOA) functionality scores with treatment. Weekly declines in self-reported stiffness of the fingers and anxiety were also reported, with these changes over time also statistically significant (p<0.001) by the end of week 4. Duyuru • Mar 01
Avecho Biotechnology Limited Announces Dosing Commencement for CBD Topical Osteoarthritis Study in collaboration with the Lambert Initiative Avecho Biotechnology Limited announced that it has commenced patient dosing for its Phase IIa Study examining whether topically applied cannabidiol (CBD) can provide relief from symptoms of osteoarthritis. The proof-of-concept Study is being run by Principal Investigator, Dr. Daniel Lewis, from the Daniel Lewis Rheumatology Centre and Co-Investigator, and Professor Iain McGregor, from the Lambert Iniative, Australia's leading research group for the discovery, development, and optimisation of safe cannabinoid therapeutics. The Study uses one of Avecho's proprietary formulation vehicles incorporating its TPM® technology. This formulation has already been shown to increase the dermal absorption of CBD in laboratory experiments by five times. Fifteen patients suffering painful arthritis of the fingers or thumb have successfully completed their baseline assessments and have now begun their treatment regimen. The topical formulation will be applied to painful joints of the fingers and/or thumb each day over a four week period. Assessment will include pain scores, functional scores, and assessments of grip strength using a dynamometer. High level results from the Study are expected Second Quarter 2022. Positive results would support the further clinical development of a topical CBD product. 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%. Duyuru • Dec 08
Avecho Biotechnology Limited Releases Results for Its Australian Phase I PK Study Characterizing the Absorption Profile of Cannabidiol from Avecho's Proprietary CBD Soft-Gel Product Avecho Biotechnology Limited released results for its Australian Phase I PK study characterizing the absorption profile of cannabidiol (CBD) from Avecho's proprietary CBD soft-gel product. The primary objective of the study was to determine the single dose pharmacokinetics (PK) of cannabidiol absorbed from a single 75 mg and 150 mg oral dose from proprietary CBD soft-gel products. This information is required for future product registration with the TGA or FDA. The 75 mg and 150 mg doses align with the TGA's down-scheduling of CBD, which has specified that future over-the-counter CBD products must have a maximum daily dose of 150 mg. The Study was conducted at CMAX in Adelaide with 16 healthy volunteers. Subjects received both doses over a period of two weeks, with each dose preceded by an overnight fast. Blood samples were collected for 48 hours after each dose and assayed for CBD content. All 16 subjects completed both treatment periods. The CBD absorption profile and pharmacokinetic parameters of both the 75 mg and 150 mg doses were well characterised. There was a linear relationship between doses with the average amount of drug absorbed from the 150 mg dose being approximately double that of the 75 mg dose. The two doses exhibit minor differences in delivery profile, with mean peak plasma concentrations for the 75 mg dose appearing 2 hours after dosing, whereas peak plasma concentrations for the 150 mg dose were evident three hours after dosing. The absorption period of the 150 mg dose was also longer, with CBD detected in the blood one week after dosing. Both doses of the CBD soft-gel were well tolerated, with all adverse events characterised as mild and no adverse events of concern related to the study medication. Duyuru • Sep 15
Avecho Commences Enrolment for Phase I Human Clinical Trial Measuring CBD Absorption Avecho Biotechnology Limited provided an update on the progress of its Australian Phase I pharmacokinetic (PK) study designed to characterise the absorption profile of cannabidiol (CBD) from its CBD soft-gel product, announcing enrolment of the first healthy volunteers. The Study will support Avecho's strategic focus of developing pharmaceutical CBD products that leverage its proprietary TPM formulations. The Study will assess Avecho's 75 mg CBD soft-gel product, which has been developed and manufactured by Catalent Inc. at its facility in Florida, US. Subjects in the study will receive two separate doses over a period of two weeks, with dosing due to begin in early October. The Study has been designed to form a key piece of a future regulatory submission, as well as to inform ongoing research and development for Avecho's CBD product portfolio and potential commercial partnerships in this space. 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. Duyuru • May 21
Avecho Biotechnology Limited Completes Pharmaceutical CBD Soft-Gel Product Avecho Biotechnology Limited has announced that the appointed manufacturer of its cannabidiol (CBD) soft-gel product, Catalent, has completed the composition and design of the dosage form intended for registration with the TGA. Avecho has previously developed prototype CBD oil formulations with increased bioavailability, and has engaged Catalent, a leading global provider of advanced drug delivery technologies, development, and manufacturing solutions, to adapt these into pharmaceutically acceptable soft-gel capsules. These CBD capsules will be used in Avecho's upcoming clinical trial campaign which includes Phase I and a pivotal efficacy study, and are the planned dosage form to be registered with the TGA. Avecho's leading prototype CBD oil formulation was refined at Catalent's St. Petersburg, Florida facility in the U.S. The refinements are designed to ensure the formulations are appropriate for inclusion in commercial capsule manufacturing lines, are compatible with candidate gelatin capsules, and most importantly, have appropriate physical and chemical stability. Commercially appropriate stability is critical given the Company's intention to register the finished product with the TGA. The finalised composition will contain 75 mg of CBD per soft-gel capsule. Reported Earnings • Mar 29
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). Over the last 3 years on average, earnings per share has increased by 77% per year but the company’s share price has only increased by 19% per year, which means it is significantly lagging earnings growth. 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). Over the last 3 years on average, earnings per share has increased by 77% per year but the company’s share price has only increased by 16% per year, which means it is significantly lagging earnings growth. Duyuru • Dec 25
Avecho Biotechnology Begins Human Trial on CBD Product Avecho Biotechnology Limited announced it has begun participation in running observational study of medicinal cannabis products, the CA Clinics Observational Study (CACOS). Avecho will test the performance of its enhanced oral cannabidiol (CBD) TPM formulation in human patients being prescribed medicinal cannabis for a range of indications. Avecho's oral CBD TPM formulation has been shown to increase the oral bioavailability of CBD in animal models and will be tested for the first time in humans in the CACOS study. The company aims to gather real world feedback on how the product performs in patients currently utilising medicinal cannabis therapy across a range of indications. Performance will be compared against commonly prescribed CBD formulations. Recruitment for the study will begin immediately, and continue on an ongoing basis throughout 2021 to maximize the number of patients dosed with both the CBD TPM and commercial comparator formulations. The CACOS study aims to recruit a total of 3,000 patients nationwide through a network of medicinal cannabis prescribing clinics and will utilise questionnaires to examine the side effects, dosage response, and treatment satisfaction of medicinal cannabis formulations on patients' health status. Data generated will help shape the future development and clinical indications for the company's pharmaceutical CBD products, whilst also exploring the potential for SAS-B prescribing. Increasing the absorption of cannabinoids will allow for differentiated cannabinoid products on market, with greater therapeutic potential and/or reduced cost to patients, which is timely given the changing regulatory landscape for these products in Australia. Earlier this month, the TGA made its down-scheduling of CBD official. In the future, registered CBD products with a maximum dose of 150 mg/day may be available to purchase directly from a pharmacist without a prescription. The CACOS study forms the companion piece to a Phase I clinical trial currently scheduled to begin toward the end of First Quarter 2021. The Phase I trial will assess the absorption of CBD from the Avecho product. Together, the data from these studies will direct the pharmaceutical CBD TPM formulation towards the most appropriate clinical indications for product registration. Duyuru • Oct 19
Avecho Biotechnology Limited Provides TPM Cannabinoid Development Program Update Avecho Biotechnology Limited announced that it is proceeding to the next phase of its recently announced cannabinoid development program - human clinical trials. This decision is supported by positive results from preliminary in vivo studies which confirmed significantly increased cannabidiol (CBD) bioavailability from oral TPM® cannabidiol formulations in rats.
The development program consists of three main components; (i) in vitro testing in simulated gastro-intestinal digestions, (ii) animal studies to assess in vivo bioavailability of candidate formulations, and (iii) subsequent human trials testing the best formulations. Researchers at Bioneer:FARMA, located within the University of Copenhagen, had previously completed the in-vitro testing, demonstrating that formulations containing TPM® significantly increased CBD solubility during gastric and intestinal in vitro digestion. In the subsequent study,
single doses of these same formulations were administered to rats using an oral gavage to characterise the CBD absorption profile over 24 hours. The average area-under-the-curve (AUC) of the CBD absorption profile and peak plasma concentration (Cmax) were calculated for each formulation. AUC and Cmax are standard measurements used to characterize drug absorption. For this study, they were used to compare the amount of CBD absorbed between different formulations. CBD absorption from formulations containing TPM® was compared against a commonly prescribed CBD product comprising CBD at 100 mg/ml. Study results: All TPM® formulations produced higher mean AUC and Cmax than the commercial CBD
formulation. Increases in AUC produced by TPM® formulations ranged from 4-40 times. Increases in Cmax produced by TPM® formulations ranged from 6-41 times. These increases were statistically significant for the best performing TPM® formulations. Further animal work may be conducted, but the dramatic increases in CBD absorption are already sufficiently compelling to initiate formal human clinical trials. Planning for these studies is already underway, with dosing expected to begin first quarter of 2021. 
