Anatara Lifesciences : Appendix 4C and Q3 FY22 Activities Report

ASX Release

Anatara Lifesciences Appendix 4C and Q3 FY22 Activities Report

Key highlights for Q3 FY22

• • Commencement of recruitment for clinical trials at CSIRO Nutrition and Health Research Clinic (Adelaide) for 3FDC in adults with mild to moderate depression, anxiety or stress

  • o Trial eligibility expanded to include participants with scores in the mild range on a minimum of one of the DASS-21 subscales (depression, anxiety, stress)

• • CSIRO Nutrition and Health Research Clinic (Adelaide) site commenced recruiting for GaRP in irritable bowel syndrome - subtype diarrhoea (IBS-D)

• • Considering additional opportunities to deliver anticipated dates for results

  • o Recruitment for GaRP in IBS-D expected to commence in Melbourne in May

  • o Further expansion of eligibility criteria for GaRP trial

• • Actively evaluating opportunities to broaden gastrointestinal health pipeline

MELBOURNE, 29 April 2022: Anatara Lifesciences (ASX: ANR), a developer of evidence-based solutions for gastrointestinal diseases in animals and humans, is pleased to provide this activities report for the quarter ending 31 March 2022 (Q3 FY22), along with the Company's Appendix 4C cash flow report.

Commenting on the quarter, CEO Steve Lydeamore said, "We are really pleased with the progress made over the quarter and excited that our clinical trials in 3FDC and GaRP in IBS-D were able to commence in Adelaide. 3FDC trials began following the successful completion of the site initiation visit, and a report on 3FDC in adult participants is expected to be delivered in late 2022.

"The Interim report for the GaRP trial in ISB-D is anticipated to be delivered in August 2022 and the final report in January 2023. Commencement of recruitment in Melbourne is anticipated to occur in May, which will help to accelerate our progress.

"While we are delighted with the response to recruitment activities to date, to further accelerate the progress of the GaRP trial, we are working with the usual regulatory authorities to allow broadening of eligibility to enhance enrolment.

"There are significant market opportunities in addressing irritable bowel syndrome and psychological health issues, while improving individuals' quality of life. There is a high prevalence of these disorders in society. Our human trials are anticipated to be impactful, as we aim towards commercialising our evidence-based solutions. During the quarter we explored opportunities to broaden our gastrointestinal health pipeline, which has yielded a number of attractive opportunities that we are evaluating."

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.

CEO Steve Lydeamore commented, "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 IBS and IBD patients, by addressing processes that contribute to the pathophysiology of these chronic bowel conditions." Anatara's GaRP complementary medicine is being developed to specifically target two human gastrointestinal disorders, irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD). IBS is the most common GI condition affecting approximately 11% of the global population while IBD affects an estimated five million people globally.

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 the 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.

CEO Steve Lydeamore commented, "There is a major unmet need and significant market opportunity for an evidence-based complementary medicine for stress, anxiety and depression. According to Beyond Blue a quarter of Australians will experience an anxiety condition in their lifetime. I am excited that Anatara's 3FDC dietary supplement may be of benefit to some of the many who experience these conditions. It is gratifying that Anatara's focus on gut health and integrity has allowed us to capitalise on our research in IBS with the potential to address other conditions that have microbiome considerations, such as those related to the "gut-brain axis" and including immune system inter-relationships. The current study has the potential, not only to help those suffering mood disorders, but to significantly add to our understanding of GaRP in non-IBS participants."

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 percent of U.S. adults have an anxiety disorder in any given year, and an estimated 31 percent 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.4 40% or more of Americans treat themselves with complementary and alternative medicine (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.5

1pharmalinea:https://pharmalinea.com/wp-content/uploads/2020/01/Stress-supplements-opportunity-news.pdf

• 2 National Center for Complementary and Integrative Health:https://www.nccih.nih.gov/health

• 3 Wemrell M et. al (2020) Issues in Mental Health Nursing, Volume 41:https://doi.org/10.1080/01612840.2020.1744203

• 4 Mental Health America:https://www.mhanational.org/issues/state-mental-health-america

• 5 Mental Health America:https://www.mhanational.org/sites/default/files/MHA_CAM.pdf

  Summary of Q3 FY22 cashflows

  The Company's cash plus term deposits at the end of the quarter stood at $1.69 million (31 December 2021: $2.56 million), which comprised cash at bank of $1.19 million and $0.50 million in term deposits.

  Net cash used in operating activities during the quarter was $0.81 million. Staff, Admin and Corporate cash outflow of $0.39 million was 33% lower than the prior quarter.

  Aggregate payments to related parties and their associates during the quarter was $46,000, a reduction of 32%, which includes directors' fees and superannuation.

  For more information please contact:

  General inquiries
  Steven Lydeamore CEO, Anatara Lifesciences Ltd +61 (0) 438 027 172slydeamore@anatara.com	Michael Pryor Head of Business Development and Marketing Communications +61 (0) 437 132 122mpryor@anatara.com

  About Anatara Lifesciences Ltd

  Anatara Lifesciences Ltd (ASX:ANR) is developing and commercialising innovative, evidence-based products for gastrointestinal health where there is significant unmet need. Anatara is a life sciences company with expertise in developing products for human and animal health. Anatara is focused on building a pipeline of human gastrointestinal health products. Underlying this product development program is our commitment to delivering real outcomes for patients and strong value for our shareholders.

Disclaimer

The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Anatara Lifesciences Ltd, ACN 145 239 872 (Company). In preparing this presentation, the Company did not take into account the investment objectives, financial situation, and particular needs of any particular investor. Further advice should be obtained from a professional investment adviser before taking any action on any information dealt with in the presentation. Those acting upon any information without advice do so entirely at their own risk. Whilst this presentation is based on information from sources which are considered reliable, no representation or warranty, express or implied, is made or given by or on behalf of the Company, any of its directors, or any other person about the accuracy, completeness or fairness of the information or opinions contained in this presentation. No responsibility or liability is accepted by any of them for that information or those opinions or for any errors, omissions, misstatements (negligent or otherwise) or for any communication written or otherwise, contained or referred to in this presentation. Neither the Company nor any of its directors, officers, employees, advisers, associated persons or subsidiaries are liable for any direct, indirect or consequential loss or damage suffered by any person as a result of relying upon any statement in this presentation or any document supplied with this presentation, or by any future communications in connection with those documents and all of those losses and damages are expressly disclaimed. Any opinions expressed reflect the Company's position at the date of this presentation and are subject to change.

Rule 4.7B

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

Name of entity

Anatara Lifesciences Ltd (ASX: ANR)

ABN

41 145 239 872

Quarter ended ("current quarter")

31 March 2022

2.

Cash flows from investing activities

2.1

Payments to acquire or for:

Appendix 4C

Quarterly cash flow report for entities subject to Listing Rule 4.7B

4.

Net increase / (decrease) in cash and cash equivalents for the period

4.1

Cash and cash equivalents at beginning of period

4.2

Net cash from / (used in) operating activities (item 1.9 above)

4.3

Net cash from / (used in) investing activities (item 2.6 above)

2,558

3,423

(811)

(1,656)

(47)

(54)

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