Anatara Lifesciences : Appendix 4C and Q2 FY22 Activities Report

ASX Release

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"We are anticipating that recruitment for both our human clinical trials for 3FDC and GaRP will take place from mid-February 2022 at the CSIRO site and other recruitment pathways for the GaRP trial are being continually reviewed and reinforced."

Anatara strengthens the team with new appointments

Michael Pryor and Simon Erskine were appointed to progress the Company's commercialisation activities in the gastrointestinal health space.

Mr Erskine joined as Chief Development Officer, with more than 10 years' experience working within the biotechnology, IVD (in vitro diagnostic) medical devices and molecular diagnostic industries. He has held numerous research and development roles including product and clinical development, regulatory affairs and quality assurance, and has successfully translated early-stage research into commercial products for the Australian, European, Canadian and US markets.

Mr Pryor's most recent role was Commercial Manager (ANZ) at MENARNI Group where he led a highly successful team, driving sales, market share and profit growth within the pharmacy channel. Mr Pryor has developed an intimate understanding of the Australian pharmacy channel and has worked across a wide range of therapeutic areas, including gut health.

The appointments of Michael and Simon will play a key role in expanding Anatara's position as an emerging leader in evidence-based gut health solutions.

Clinical trials update

IBS-D

The IBS-D study consists of two stages (Stage 1, Stage 2), with an interim analysis between stages. Stage 1 will assess the safety, tolerability and efficacy of two different strengths of GaRP against placebo in a 1:1:1 randomisation protocol. Following interim analysis, one dose will be selected, and the remaining participants recruited in a 1:1 randomisation protocol. Of the 200 planned participants, at least 90 will enrol in stage 1, and 110 participants will enrol in stage 2. 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.

Anatara continues to take actions to recover trial participants in the IBS-D trial. Potential trial participants were previously excluded as their IBS Symptom Severity Scores (IBS-SSS) were marginally higher than the trial inclusion criteria, however, Anatara applied for, and received, ethics approval to modify the criteria which has now expanded the pool of potential patients.

Recruitment has commenced, but has been significantly hindered by the impact of Omicron, with Anatara adding an additional site in Adelaide for the IBS-D trial but recruitment has been delayed into February 2022 . This new site will target recruitment of up to 50 participants. The Company has also 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.

Anatara Lifesciences Limited

Registered Office

Level 3, 62 Lygon Street, Carlton South, VIC, 3053, Australia

Administration and R&D

343 Royal Parade, Parkville, Melbourne, VIC 3052, Australia Email info@anatara.com | Website anataralifesciences.com

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Psychological functioning

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.

Commenting on progress made towards the human clinical studies, CEO Steve Lydeamore said,

"While we anticipated a pause in recruiting over the Christmas break, as well as the potential impact of diet and lifestyle during that period, investigational product was not received from India in time to commence recruitment for the psychological functioning trial prior to Christmas.

"Following this, the recent escalation in COVID-19 cases means that IBS-D recruitment at the new Adelaide site will not commence until the end of February due to COVID-19 restrictions at CSIRO's Adelaide facility. The CSIRO advised of the need to push back the timeframes to allow appropriate management of staff and resources during the Omicron COVID-19 uncertainty. For the same reason the start date of the 3FDC trial is delayed until the end of February.

"There is a major unmet need and significant market opportunity for an evidence-based complementary medicine for IBS. Anatara's GaRP has demonstrated that it has the potential to manage the devastating symptoms experienced by IBD and IBS patients, by addressing processes that contribute to the pathophysiology of these chronic bowel conditions. Although we're experiencing temporary delays due to COVID-19, we remain highly optimistic that our technology has the potential to make a substantial positive impact to gastrointestinal health and we look forward to the resumption of recruitment activities next month."

Summary of Q2 FY22 cashflows

The Company's cash plus term deposits at the end of the quarter stood at $2.56 million (30 September 2021: $2.53 million), which comprised cash at bank of $1.56 million and $1.00 million in term deposits. During December the Company received an R&D Tax Incentive of $736k.

Net cash inflow during the quarter was $0.05 million. Staff, Admin and Corporate cash outflow of $0.59 million was 2.4% higher than the prior quarter.

Aggregate payments to related parties and their associates during the quarter was $68,000 which includes directors' fees and superannuation.

Anatara Lifesciences Limited

Registered Office

Level 3, 62 Lygon Street, Carlton South, VIC, 3053, Australia

Administration and R&D

343 Royal Parade, Parkville, Melbourne, VIC 3052, Australia Email info@anatara.com | Website anataralifesciences.com

Anatara Lifesciences Limited

Registered Office

Level 3, 62 Lygon Street, Carlton South, VIC, 3053, Australia

Administration and R&D

343 Royal Parade, Parkville, Melbourne, VIC 3052, Australia Email info@anatara.com | Website anataralifesciences.com