Anavex Life Sciences Corp.

Welcome to the Anovex Life Sciences fiscal 2022 first quarter conference call. My name is Clint Tomlinson, and I will be your host for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. And during this session, if you would like to ask a question, please use the Q&A box or raise your hand. Please note that this conference is being recorded. The call will be available for replay on Anovex's website at www.anovex.com. With us today is Dr. Christopher Misling, President and Chief Executive Officer, and Sandra Bonish, our Principal Financial Officer. Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. We encourage you to review the company's filings with the SEC. This includes, without limitation, the company's forms 10-K and 10-Q, which identify the specific factors that may cause actual results or even events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, risks inherent in the development and or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. And with that, I would like to turn the call over to Dr. Misling.

Thank you, Clint. And we appreciate everyone joining us on today's conference call to review our most recently reported financial results and to provide a business update. The first quarter marked significant progress across our portfolio. highlighted by the positive top-line results of the randomized placebo-controlled avatar phase three study for the treatment of adult patients with Rett syndrome, and the positive top-line results from the placebo-controlled phase one study of ANAVEX 371, which is in development for the treatment of neurodegenerative diseases, including FDD, frontodermature, and the clinical data-driven evidence of efficacy and safety of our broad Sigma-1 platform portfolio. which allows us to plan and to expand further into the rare disease space, including implementing expanded access for dull patients with Rett syndrome and underserved population. At the same time, We are advancing both ANOVAX273 and ANOVAX371 in the planned studies with the goal to driving meaningful growth across our broad Sigma-1 platform portfolio to deliver transformational treatments for patients with both degenerative and developmental neurological disorders around the world. Starting with our lead drug candidate, 273, we reported positive top-line results from the second randomized placebo-controlled Avada Phase III study for the treatment of adult patients with Rett syndrome. This study met its primary and secondary efficacy and safety endpoints. with consistent and clinically meaningful improvements in all efficacy measures of Rett syndrome symptoms. Convenient once-daily oral liquid doses of up to 30 mg of ANVEX273 were also well tolerated with good medication compliance. Based on the results of the Avatar phase three study and the prior successful US phase two study in adult patients with Rett syndrome, Anavex is now planning to meet with the FDA to discuss the approval pathway. Topline results from the placebo-controlled excellence phase 2-3 study for the treatment of patriotic patients with Rett syndrome are expected in second half of 2022. The extension of the expected duration of enrollment is based on recent country and local government requirements for children to have full COVID-19 vaccination prior to joining a clinical trial, which includes our patriotic excellence trial. This phase 2-3 study in pediatric patients with RAD syndrome age 5 to 17 will evaluate the safety and efficacy of 273 in approximately 84 patients over a 12-week treatment period, including Anavex 273-specific precision medicine biomarkers. Regarding our Alzheimer's disease program, top-line results from the randomized placebo-controlled phase 2B-3, Anavex 273-AD004 study for the treatment of Alzheimer's disease are also expected in the second half of 2022. The 509 patients late stage phase 2B-3 study in patients with Alzheimer's disease is taking place at 52 sites across North America, Europe, and Australia using ADAS-COG for cognition and ADCS-ADL for activities of daily living and function as primary endpoints. This clinical trial is measuring efficacy, tolerability and safety of two different ones daily oral 273 doses or placebo. The current data allows us to expand in parallel our Anavex platform pipeline using gene variant markers of response, applying precision medicine for neurological disorders with unmet medical need, which are expected in 2022. That includes the planned initiation of Anavex 203 imaging-focused Parkinson's disease clinical study, a planned initiation of a potential pivotal phase II slash III study in fragile X syndrome, the most frequent genetic cause of autism spectrum disorder, and a planned initiation of a phase II slash III clinical trial for the treatment of a new rare disease indication. As well, last month, Anavex reported positive top line results from the placebo control phase one, Anavex 371 clinical trial, in development for the treatment of neurodegenerative diseases, including FTD, frontotemporal dementia, for which Anavex 371 has been granted orphan drug designation by the FDA. The study reached primary and secondary endpoints of safety with no serious adverse events or dose limiting toxicity observed. Anavex 371 was well tolerated in all cohorts receiving Anavex 371 in single doses ranging from 5 mg to 200 mg daily with no serious adverse events and no significant lab abnormalities in any subject. Based on these results in Anavex 371's preclinical profile, we intend to advance 371 into a biomarker-driven clinical development dementia program for the treatment of FTD, frontotemporal dementia, schizophrenia, and Alzheimer's disease, evaluating longitudinal effect of treatment with Anavex 371. We believe that the results of these studies could serve as the basis for advancing into respective registration studies in the US. And now, I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex, for a brief financial summary of the recently reported quarter.

Thank you, Christopher. And good afternoon to everyone on the call. Our cash position at December 31, 2021, was 151.1 million, which we believe is sufficient cash runway to fund operations and clinical programs beyond 2025. For the first quarter, cash utilized in operations was 3.5 million. We reported a net loss of 10.9 million for the quarter, or 14 cents per share, inclusive of non-cash compensation charges of 3.9 million. compared to net loss of 7.9 million or 12 cents per share, inclusive of non-cash compensation of 0.9 million for the comparable quarter of fiscal 2021. Our research and development expenses for the first quarter of fiscal 2022 were 8.7 million as compared to 7.9 million for the first quarter of fiscal 2021. General and administrative expenses were 3.1 million compared to 1.5 million for the comparable quarter of fiscal 2021. In both cases, the increases are primarily related to an increase in non-cash compensation charges of 1.7 million for research and development and 1.3 million for general and administrative expenses, period over period. These increases in non-cash compensation are mainly driven by the addition of staff to manage and support our clinical studies and development. Thank you, and I'll turn it back over to Christopher.