Anavex Life Sciences Corp.

Welcome to the Anovex Life Sciences Fiscal 2023 Second 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'll 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, this conference is being recorded. The call will be available for replay on Anovex's website at www.anovex.com. With us today, Dr. Christopher Misling, President and Chief Executive Officer, and Sondra Burnish, 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. And this includes without limitation, the company's forms 10K and 10Q, which identify specific factors that may cause actual events or results 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 good morning, everyone. Thank you for being with us today to review our most recently reported financial results and to provide our quarterly business update. Recent positive clinical study results and FDA approvals through the accelerated approval pathway are positive for the Alzheimer's disease community, especially for patients, families, and caregivers who fight every day against this devastating disease. We look forward to presenting, including in a scientific journal once available, the complete data set of the Phase 2b-3 Alzheimer's disease trial of Anavex 273, Blacarmazine, a convenient once-daily oral small molecule activator of the upstream Sigma-1 receptor. involved in restoring neural cell homeostasis and promoting neuroplasticity, which might be at the forefront of patient-centric next-generation biomarker-guided precision medicine Alzheimer's disease treatments. With newly available preliminary efficacy results of surrogate biomarkers, we consider initiating discussions with regulatory agencies for accelerated approval pathway for Anavax273. In parallel, we plan to proceed with the initiation of a confirmatory Alzheimer disease study. We also look forward to making meaningful advances in our neurodevelopmental and other neurodegenerative precision medicine portfolio this year. In February, we announced completion of enrollment in the Excellence Phase 2-3 study, RS003, for the treatment of patriotic diseases. patients with Rett syndrome. We expect to announce top-line results from this potentially pivotal clinical trial in the second half of 2023. At the end of March, we reported the preliminary data of the 48-week open-label extension Parkinson's disease dementia clinical trial. The open-label study demonstrated the longitudinal beneficial effect of underVEX273 on the pre-specified primary and secondary objectives, as well as on the planned primary and key secondary endpoints. It is encouraging that the patient's clinical symptoms consistently improved longitudinally over time during the extension phase under active underVEX273 treatment. This data suggests that ANAVEX273 has the potential to slow and potentially reverse the life-altering symptoms of Parkinson's disease, an urgent unmet global need. Following on these promising results, we intend to use the same endpoints in a forthcoming pivotal study of ANAVEX273 in Parkinson's disease. Further, pipeline expansion of the Anavex platform using gene biomarkers of response, applying precision medicine for neurological disorders is expected, including planned initiation of a Anavex 273 imaging-focused Parkinson's study, which is sponsored by the Michael J. Fox Foundation, a planned initiation of a potentially pivotal Anavex 273 phase 2-3 clinical trial in Frederick syndrome, a planned initiation of an Anvix 371 Phase II clinical trial in schizophrenia. a planned initiation of a potentially pivotal ANOVAX203 phase two slash three clinical trial for the treatment of a new rare disease indication, and several clinical publications involving ANOVAX273, ANOVAX371, and a Rett syndrome burden of illness study. In conjunction with these planned developments, we continue to expand and strengthen our team to support our objectives, including adding a former FDA statistical team leader as head of biostatistics, as well as other industry professionals to manage and support our studies. Finally, we are pleased with the recent expansion of the patent portfolio for Anavex 2.3 into the indication of hypertension. Hypertension or high blood pressure affects nearly half of adults in the United States. especially within our aging society. This new patent will add to our already robust patent portfolio relating to Arnavix 273 and further demonstrates our strong overall commitment to protecting a full range of commercial opportunities of our product portfolio. And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Arnavix for a brief financial summary of the recently reported quarter.

Thank you, Christopher. Good morning to everyone. I am pleased to share with you today our second quarter financial results. During our most recent quarter, general and administrative expenses remained consistent year over year at 2.9 million. Our research and development expenses for the quarter were 11.3 million as compared to 8.6 million for the comparable quarter of fiscal 2022. The increase in research and development was primarily a result of expanding our team as well as an increase in drug manufacturing activities and development for future clinical and potential market supply. Overall, we reported a net loss of 13.1 million, which is 17 cents per share, inclusive of 4.8 million in non-cash items. Our cash position on March 31st was 153.5 million. During the quarter, we utilized cash and cash equivalents of 8.5 million to fund our operations. At these current cash utilization rates, we believe we have sufficient cash runway to fund operations and clinical programs beyond the next four years, consistent with guidance that we've provided in previous quarters. Thank you, and now back to you, Christopher.