New Risk • Feb 26
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$1.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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$1.1m free cash flow). Share price has been highly volatile over the past 3 months (18% average weekly change). Shareholders have been substantially diluted in the past year (48% increase in shares outstanding). Revenue is less than US$1m (AU$624k revenue, or US$444k). Market cap is less than US$10m (AU$3.16m market cap, or US$2.25m). New Risk • Jan 20
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (47% increase in shares outstanding). Revenue is less than US$1m (AU$969k revenue, or US$653k). Market cap is less than US$10m (AU$3.76m market cap, or US$2.54m). Minor Risk Share price has been volatile over the past 3 months (14% average weekly change). New Risk • Nov 28
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 51% 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 Shareholders have been substantially diluted in the past year (51% increase in shares outstanding). Revenue is less than US$1m (AU$969k revenue, or US$633k). Market cap is less than US$10m (AU$3.76m market cap, or US$2.46m). Minor Risk Share price has been volatile over the past 3 months (19% average weekly change). Announcement • Nov 27
Anatara Lifesciences Ltd has completed a Follow-on Equity Offering in the amount of AUD 1.2 million. Anatara Lifesciences Ltd has completed a Follow-on Equity Offering in the amount of AUD 1.2 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 33,647,583
Price\Range: AUD 0.012
Discount Per Security: AUD 0.00072
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 59,685,751
Price\Range: AUD 0.012
Discount Per Security: AUD 0.00072
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 6,666,666
Price\Range: AUD 0.012
Transaction Features: Subsequent Direct Listing New Risk • Oct 28
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 28% 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 (23% average weekly change). Revenue is less than US$1m (AU$969k revenue, or US$638k). Market cap is less than US$10m (AU$3.46m market cap, or US$2.28m). Minor Risk Shareholders have been diluted in the past year (28% increase in shares outstanding). Announcement • Oct 02
Anatara Lifesciences Ltd has filed a Follow-on Equity Offering in the amount of AUD 1.2 million. Anatara Lifesciences Ltd has filed a Follow-on Equity Offering in the amount of AUD 1.2 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 33,647,583
Price\Range: AUD 0.012
Discount Per Security: AUD 0.00072
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 59,685,751
Price\Range: AUD 0.012
Discount Per Security: AUD 0.00072
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 6,666,666
Price\Range: AUD 0.012
Transaction Features: Subsequent Direct Listing Announcement • Sep 15
Anatara Lifesciences Ltd, Annual General Meeting, Nov 20, 2025 Anatara Lifesciences Ltd, Annual General Meeting, Nov 20, 2025. Announcement • Feb 28
Anatara Lifesciences Ltd Announces Board Changes Anatara Lifesciences announced the resignation of non-executive director Mr. Nicholas Haslam due to other business commitments, effective immediately. Mr. Jonathan Lindh has been appointed as a non-executive director that will accompany his continuing role as Company Secretary. Jonathan Lindh is a lawyer with over 15 years of legal and company secretarial experience. He has worked in private practice for Australian and international law firms, and for a boutique corporate advisory business. Jonathan has experience advising listed and unlisted private and public companies on a broad range of matters including mergers & acquisitions, divestments, capital raisings, joint ventures, supply/offtake agreements, foreign investment, corporate governance and corporate law issues. Jonathan has also served as company secretary of a number of ASX listed companies and other private and public companies operating in various industries. New Risk • Feb 26
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$1.9m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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$1.9m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m (AU$251k revenue, or US$158k). Market cap is less than US$10m (AU$11.7m market cap, or US$7.42m). Minor Risk Shareholders have been diluted in the past year (27% increase in shares outstanding). Announcement • Dec 20
Anatara Lifesciences Ltd has completed a Follow-on Equity Offering in the amount of AUD 0.2745 million. Anatara Lifesciences Ltd has completed a Follow-on Equity Offering in the amount of AUD 0.2745 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 5,490,000
Price\Range: AUD 0.05
Discount Per Security: AUD 0.003 Announcement • Nov 23
Anatara Lifesciences Ltd has completed a Follow-on Equity Offering in the amount of AUD 0.75 million. Anatara Lifesciences Ltd has completed a Follow-on Equity Offering in the amount of AUD 0.75 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 15,000,000
Price\Range: AUD 0.05
Discount Per Security: AUD 0.003
Transaction Features: Subsequent Direct Listing Announcement • Sep 10
Anatara Lifesciences Ltd, Annual General Meeting, Nov 14, 2024 Anatara Lifesciences Ltd, Annual General Meeting, Nov 14, 2024. New Risk • Aug 06
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 16% 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 (16% average weekly change). Shareholders have been substantially diluted in the past year (61% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (AU$9.07m market cap, or US$5.88m). Announcement • Jul 11
Anatara Lifesciences Ltd has completed a Follow-on Equity Offering in the amount of AUD 1 million. Anatara Lifesciences Ltd has completed a Follow-on Equity Offering in the amount of AUD 1 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 23,250,000
Price\Range: AUD 0.04
Discount Per Security: AUD 0.0024
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,750,000
Price\Range: AUD 0.04
Discount Per Security: AUD 0.0024
Transaction Features: Subsequent Direct Listing New Risk • May 22
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 59% 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 Shareholders have been substantially diluted in the past year (59% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (AU$7.65m market cap, or US$5.10m). Minor Risk Share price has been volatile over the past 3 months (18% average weekly change). Announcement • May 01
Anatara Lifesciences Ltd has filed a Follow-on Equity Offering in the amount of AUD 1 million. Anatara Lifesciences Ltd has filed a Follow-on Equity Offering in the amount of AUD 1 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 23,250,000
Price\Range: AUD 0.04
Discount Per Security: AUD 0.0024
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,750,000
Price\Range: AUD 0.04
Discount Per Security: AUD 0.0024
Transaction Features: Subsequent Direct Listing New Risk • Apr 08
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 17% 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 Less than 1 year of cash runway based on free cash flow trend (-AU$1.5m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (AU$6.55m market cap, or US$4.32m). Minor Risk Shareholders have been diluted in the past year (40% increase in shares outstanding). New Risk • Dec 19
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 51% 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 Shareholders have been substantially diluted in the past year (51% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (AU$3.69m market cap, or US$2.49m). Announcement • Dec 11
Anatara Lifesciences Ltd has completed a Follow-on Equity Offering in the amount of AUD 1.315185 million. Anatara Lifesciences Ltd has completed a Follow-on Equity Offering in the amount of AUD 1.315185 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 16,343,136
Price\Range: AUD 0.022
Discount Per Security: AUD 0.00132
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 29,905,116
Price\Range: AUD 0.022
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 13,532,851
Price\Range: AUD 0.022
Transaction Features: Rights Offering New Risk • Dec 11
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 54% 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 Shareholders have been substantially diluted in the past year (54% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (AU$4.05m market cap, or US$2.66m). Board Change • Dec 04
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 3 non-independent directors. COO & Executive Director John Michailidis was the last director to join the board, commencing their role in 2023. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Nov 04
Anatara Lifesciences Ltd has filed a Follow-on Equity Offering in the amount of AUD 1.055331 million. Anatara Lifesciences Ltd has filed a Follow-on Equity Offering in the amount of AUD 1.055331 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 16,343,091
Price\Range: AUD 0.022
Discount Per Security: AUD 0.00132
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 31,626,500
Price\Range: AUD 0.022
Transaction Features: Rights Offering Announcement • Sep 20
Anatara Lifesciences Ltd, Annual General Meeting, Nov 10, 2023 Anatara Lifesciences Ltd, Annual General Meeting, Nov 10, 2023, at 10:00 AUS Central Standard Time. Board Change • Jul 20
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 Director Jane Ryan was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Dec 07
Anatara Lifesciences Ltd Announces board Changes Anatara Lifesciences Limited announced the following Board changes. As of 7 December 2022, Sue MacLeman will retire as Non-Executive Director at Anatara as foreshadowed at the Company's AGM in November. Sue joined the Anatara Board as Non-Executive Chair in August 2018, providing valuable guidance throughout the Company's transition beyond animal health to the clinical validation of gastrointestinal health products for humans. Sue has chaired the Audit and Risk Committee since stepping back from the Non-Executive Chair role in 2021. The Board sincerely thanks Sue for her commitment and guidance over the last four years. As of 7 December 2022, Nick Haslam has been appointed as Non-Executive Director at Anatara. Nick is a chartered accountant with ten years of experience in professional services within M&A and restructuring at PwC. Nick is currently the Chief Executive Officer of Plasma Shield Limited, an Australian medical device company. Additionally, Nick held commercial leadership roles within professional sports, which included scaling up KangaTech, a medical device and injury prevention business, with customers spread across Australia, the US and Europe. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. No highly experienced directors. Executive Chairman David Brookes was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Oct 04
Anatara Lifesciences Limited, Annual General Meeting, Nov 11, 2022 Anatara Lifesciences Limited, Annual General Meeting, Nov 11, 2022, at 12:00 AUS Eastern Standard Time. Announcement • Oct 03
Anatara Lifesciences Limited Provides Updates on 3FDC Clinical Trial Anatara Lifesciences provided an important operational update regarding the psychological functioning study being conducted by the CSIRO using 3FDC. 3FDC - Psychological functioning trial: The psychological functioning study being conducted by the CSIRO using 3FDC was in the process of recruiting 100 patients with mild to moderate levels of depression, anxiety, or stress symptoms indicated by the Depression, Anxiety and Stress Scale (DASS-21). During review of all Anatara clinical trials, it became apparent that the sample size required to detect a signal in this study may be higher than initially proposed to reach a reliable outcome. Whilst it is common for anxiety and depression trials to have high placebo responses, the Board of Anatara have elected to halt the study on the balance of outcome probability rather than considering a commitment to significant future costs. Whilst there remains a strong rationale regarding the influence on the "gut-brain" axis and the homeostasis of the microbiome, Anatara remains focused on the GaRP Irritable Bowel Syndrome (IBS) 200 patient clinical trial which the Company continues to prioritise, striving to achieve interim results by Q1CY2023. In line with the Company's vision, the IBS trial delivers on company's strategic imperative to develop and commercialise innovative, evidence-based products for gastrointestinal health. In addition, the Hospital Anxiety and Depression Scale (HADS) and Quality of Life (QOL) assessments within the questionnaire of the GaRP clinical trial will allow for preliminary analyses of the influence of the total GaRP components, in participants with gastrointestinal symptoms, on depression and anxiety. GaRP potentially has broad indications for use in conditions requiring a product to restore and maintain both the gastrointestinal tract lining and function, and the homeostasis of the microbiome. The GaRP-IBS trial data is anticipated to provide insight regarding the relationship of anxiety and depressive symptoms with gut disorders (which is in keeping with the general interest in the gut-brain axis) and provide preliminary information about progressing the use of the full GaRP complementary medicine, including the 3FDC components, for the indication of mild depression and/or anxiety in the future. Announcement • May 20
Anatara Lifesciences Updates on Progress of Clinical Trials in Psychological Functioning and Irritable Bowel Syndrome, Diarrhoea Subtype Anatara Lifesciences provided an update on progress of clinical trials in psychological functioning and irritable bowel syndrome, diarrhoea subtype (IBS-D). The Company also provides a brief operational update. Human clinical trials for IBS-D (GaRP) and psychological functioning (3FDC) Globally there is a high prevalence of digestive disorders requiring relief from both symptoms and the disease process, including irritable bowel syndrome (IBS). There is also increasing interest in the "gut- brain" axis and the influences of the microbiome. The GaRP and 3FDC complementary medicines provide a significant market opportunity to address these considerations whilst improving individuals' quality of life. The revised protocol for the IBS trial expands eligibility to all IBS subtypes other than IBS-C (constipation subtype). It required minor adjustments to the primary and secondary endpoints. With this change, the company will be able to re-screen more than 300 potential participants who were unable to enrol due to not having diarrhoea predominant IBS. The changed protocol will be updated in the recruitment website and the Obvio Health ClaimIt online portal and mobile app by 27 June. The revised protocol for the psychological functioning expands eligibility to participants with scores in the moderate range on a minimum of one of the DASS-21 subscales to also include participants with scores in the mild range on a minimum of two of the DASS-21 subscales. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. No highly experienced directors. Independent Non-Executive Chairman David Brookes was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Mar 31
Anatara Lifesciences Provides Clinical Trials Update Anatara Lifesciences provided an update on progress of clinical trials in psychological functioning and irritable bowel syndrome, diarrhoea subtype (IBS-D). Continuing recruitment for two human clinical trials with ethics approval: GaRP in Irritable Bowel Syndrome - diarrhoea subtype (IBS-D); Trial sites: Paratus Clinical Research (Brisbane, Canberra, Central Coast NSW, Western Sydney); CSIRO Nutrition and Health Research Clinic (Adelaide); Anticipated results: Interim August 2022; Final January 2023; 3FDC in psychological functioning (anxiety, depression, stress); Trial site: CSIRO Nutrition and Health Research Clinic (Adelaide); Anticipated results: Final late 2022; Exploring opportunities to bring forward anticipated dates for results; Further expansion of eligibility criteria for both trials; Anticipated addition of Melbourne site for IBS-D trial in May 2022. Announcement • Feb 17
Anatara Lifesciences Limited Provides Clinical Trials Update on Progress of Clinical Trials in Psychological Functioning and Irritable Bowel Syndrome, Diarrhoea Subtype Anatara Lifesciences provided an update on progress of clinical trials in psychological functioning and irritable bowel syndrome, diarrhoea subtype (IBS-D). Following successfulcompletion of the site initiation visit, recruitment will commence on 21 February 2022. The final study report is anticipated in late 2022. "This CSIRO site has also been initiated for the GaRP trial in IBS-D and recruitment has commenced. The interim report is anticipated in August 2022 and the final report in January 2023. Anatara's 3FDC is several of the components of the GaRP (Gastrointestinal reprogramming) complementary medicine. The 3FDC components are coated for targeted release predominately beyond the small intestine to allow delivery and influence in the large intestine. The 3FDC components are anticipated to have direct and indirect effects including assisting the homeostasis of a healthy microbiome. The delivery of these components and the microbiome influences are considered important for gut-brain axis balance, hence the 3FDC components have been selected to explore their effect on depression, anxiety and stress symptoms in otherwise healthy individuals. This randomised, double-blinded, placebo-controlled study into the effects of 3FDC in adults with moderate anxiety, stress or depression will be conducted at CSIRO's Nutrition and Health Research Clinic in Adelaide. Approximately 100 participants will be randomised in a 1:1 manner for treatment with 3FDC or a placebo, dosed twice a day for 6 weeks. Anatara's 3FDC components have been selected to explore their effect on mood, anxiety and stress in otherwise healthy individuals as the delivery of these components to the large intestine is considered likely to have beneficial effects on the gut-brain axis including positively influencing the homeostasis of the microbiome . Mood/relaxing supplements were 1,3 billion EUR in 2019 (Euromonitor's Health and Nutrition Survey Jan & Feb. 2020).1 About 19% U.S. adults have an anxiety disorder in any given year, and an estimated 31% have an anxiety disorder at some time in their lives, and depression is a medical condition that affects about 1 in 10 U.S. adults.2 An estimated 38.2% of the population of the EU member states (approximately 165 million people; 2010) met the criteria for a psychiatric disorder, while fewer than one-third received treatment for it (Wittchen et al., 2011).3 24% of U.S. adults with a mental illness report an unmet need for treatment. 40% or more of Americans treat themselves with CAM without professional supervision, often without disclosing it to their psychiatrist or primary care provider. People considering using CAM treatments need to make an informed decision, just as they would with any synthetic medication or other treatment, weighing the evidence about effectiveness, drug interactions, side effects, and less dangerous options, to come up with a risk/benefit assessment. Board Change • Feb 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. No highly experienced directors. Independent Non-Executive Chairman David Brookes was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Dec 16
Anatara Lifesciences Limited Provides Update on Progress of Clinical Trials in Psychological Functioning and Irritable Bowel Syndrome Anatara Lifesciences Limited provided an update on progress of clinical trials in psychological functioning and irritable bowel syndrome, diarrhoea subtype (IBS-D). On 16 November at the AGM, Anatara anticipated commencing recruitment for the psychological functioning trial by the end of November and interim results for the IBS-D trial in April 2022. Anatara is adding an additional site in Adelaide for the IBS-D trial which will target recruitment of up to 50 participants and has engaged Evrima, a specialist in patient identification and recruitment. Evrima will support Anatara's IBS-D trial by both direct-to-patient and direct-to-clinician channels. Direct-to-patient will increase community awareness via social media, digital marketing campaigns and radio advertising. Direct-to-clinician will generate awareness within the GP community, as well as through the use of their proprietary software to identify potentially eligible patients via electronic health records in Australia. 3FDC is one of the components of Anatara's GaRP (Gastrointestinal reprogramming) complementary medicine. GaRP is a combination of two different minitablets, which is under investigation in another study focused on diarrhoea predominant Irritable bowel syndrome (IBS-D). The different minitablets in the formulation target different parts of the gastrointestinal tract. 3FDC is targeted to release at the junction between the small and large intestine (ileocecal junction) and exert its effects on the microbiome in the large intestine. Since restoration of a healthy microbiome is considered important for gut-brain axis balance, the 3FDC components have been selected to explore their effect on depression, anxiety and stress symptoms in otherwise healthy individuals. Announcement • Jun 01
Anatara Lifesciences Provides This Update on Clinical Trial Activities Anatara Lifesciences provided this update on clinical trial activities. Anatara has strong pre-clinical data to support GaRP use in IBS, the most commonly diagnosed gastrointestinal condition and a significant cost burden on health care. In February, Anatara announced that it had received Human Research Ethics Committee approval to undertake a clinical trial of GaRP for participants with irritable bowel syndrome - diarrhoea subtype (IBS-D), having completed the required pre-clinical safety and efficacy testing. The company now anticipates launching the trial recruitment website and screening of subjects for enrolment in the trial within the next two weeks. Recruitment for phase one of this trial is anticipated to be completed in December 2021 following which a futility analysis will be undertaken to determine which dose of GaRP will progress in phase two of this trial. In April, Anatara advised that it had received Human Research Ethics Committee approval to undertake a clinical trial on the effects of 3FDC dietary supplementation on psychological functioning in an adult population, in collaboration with CSIRO. 3FDC is one of the components of Anatara's GaRP dietary supplement that exerts its effects due to absorption characteristics and influence on the microbiome in the large intestine. The gut-brain axis balance is considered important for depression, anxiety and stress symptoms in otherwise healthy individuals. The components of 3FDC and the delivery coating target the complex physiology of these considerations by ensuring the components are able to influence the important and relevant section of the GIT (gastrointestinal tract or `gut'). The CSIRO team will develop the work guidelines and initiate recruitment with the aim of dosing the first participants in the third quarter of calendar year 2021. Anatara anticipates commencing screening of subjects in August 2021. Recent Insider Transactions • Apr 16
Insider recently sold AU$177k worth of stock On the 13th of April, Tracey Mynott sold around 811k shares on-market at roughly AU$0.22 per share. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. Reported Earnings • Feb 24
First half 2021 earnings released: AU$0.016 loss per share (vs AU$0.036 loss in 1H 2020) First half 2021 results: Net loss: AU$1.03m (loss narrowed 43% from 1H 2020). Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Announcement • Feb 08
Anatara Lifesciences Receives Ethics Approval to Start IBS Trial Anatara Lifesciences advised that it is has received Human Research Ethics Committee (HREC) approval to undertake a clinical trial of its Gastrointestinal Re-Programming complementary medicine (GaRP) in participants with irritable bowel syndrome diarrhoea subtype (IBS-D). Ethics approval is confirmation Anatara has completed the necessary pre-clinical safety and efficacy testing of GaRP required to commence human clinical studies. Now that HREC approval of the protocol has been received, the company is able to immediately undertake site initiation procedures a prerequisite for patient recruitment which is planned for March 2021. This randomised, double-blind, placebo-controlled study will be conducted in two stages as a virtual study using ObvioHealth Australia's ClaimIt platform. This involves minimal on-site visits and participants completing most assessments online. Up to 6 sites will be established by Sonic Clinical Trials and approximately 200 participants enrolled. GenesisCare Clinical CRO will provide medical advisory and medical monitoring services whereas Microba will provide microbiome testing using shotgun metagenomic sequencing and proprietary bioinformatics. The study design consists of two stages, with an interim analysis between stages. Following interim analysis, one dose will be selected, and the remaining participants recruited in a 1:1 randomisation protocol. For each participant in each stage, the study will last for 12 weeks; including 8 weeks of treatment, preceded by a 2-week screening/baseline period and followed by a 2-week washout period. Measurements will include a number of surveys including the IBS specific surveys: IBS-SSS (severity scoring system), IBS QoL (quality of life) and IBS-AR (adequate relief) and Bristol Stool Form Scale. Announcement • Feb 02
Anatara Lifesciences Announces Successful Poultry Trial Anatara Lifesciences announced successful completion of the poultry challenge trial Efficacy of ANR-pf on the performance of broilers subject to subclinical and necrotic enteritis challenges. ANR-pf is Anatara's proprietary enriched
formulation for poultry in water, designed to allow the full delivery of key additives in a quick and flexible formulation for poultry in water, designed to allow the full delivery of key additives in a quick and flexible
dosing method on-farm even when stock illness is a concern. The study was a randomised, placebo controlled trial. The parameters analysed were bird weight gain (WG), feed intake (FI), feed conversion ratio (FCR), and more complex analysis such as an intestinal lesion score of necrosis and ulceration, and oocyst count in the excreta. Necrotic enteritis (NE) in broiler chickens is a common disease found in all poultry-growing areas of the
world which can be controlled by antibiotics. Increasing concerns regarding antibiotic resistance and the presence of drug residues in bacteria during animal production have led many countries to ban the use of antibiotic growth promoters in animal feed. There is a consensus that the sub-clinical form of the disease is more important than the clinical form because it may persist in broiler flocks without overt clinical manifestation. Moreover, due to the large hidden economic costs associated with sub-clinical NE, and also because of the high risk of pathogen transfer to the food chain, this problem is perceived amongst the industry and public health experts as a major issue. With a European ban and worldwide phasing-out of in-feed antibiotics, the focus on alternative strategies has increased to secure chicken health and thus the efficiency of poultry production. In the presence of a necrotic enteritis challenge, ANR-pf in water provides a positive effect on both performance and health as measured by lesion scores and the shedding of oocysts compared to untreated birds. Lesion scores measure the extent of necrosis and ulceration resulting from necrotic enteritis. Oocysts are a stage in the life cycle of coccidian parasites. An oocyst count is a measure of the extent of coccidiosis. Mild coccidiosis is a predisposing factor to induce necrotic enteritis. When analysed over the entire experimental period (0-35 days), treatment with ANR-pf in water provided benefit when compared to untreated birds in weight gain (p=0.007), feed intake (p=0.039), as well as lesion scores in both the jejunum (p=0.040) and ileum (p=0.035), and oocyst shedding (p <0.05). The difference in feed conversion rate was also improved, though failed to reach statistical significance. Announcement • Nov 30
Anatara Lifesciences Limited Announces Cessation of Tracie Elizabeth Ramsdale as Director Anatara Lifesciences Limited announced that Tracie Elizabeth Ramsdale ceased to be director of the company. Date that director ceased to be director is 26 November 2020. Announcement • Oct 19
Anatara Lifesciences Limited Announces Retirement of Tracie Ramsdale as Non-Executive Director Anatara Lifesciences announced that Dr. Tracie Ramsdale is retiring by rotation at the upcoming AGM in accordance with Listing Rule 14.5 and rule 19.3(a) of the Company's constitution. Dr. Ramsdale is not seeking re-election. Announcement • Aug 28
Anatara Lifesciences Limited Auditor Raises 'Going Concern' Doubt Anatara Lifesciences Limited filed its Annual on Aug 24, 2020 for the period ending Jun 30, 2020. In this report its auditor, Grant Thornton, gave an unqualified opinion expressing doubt that the company can continue as a going concern.