Anavex Life Sciences Corp. (NASDAQ:AVXL) Q1 2023 Earnings Call Transcript February 7, 2023

Clint Tomlinson: Good morning, everyone. And welcome to the Anavex Life Sciences' Fiscal 2023 First Quarter Conference Call. My name is Clint Tomlinson, and I'll 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. Please note that this conference is being recorded. The call will also be available for replay on Anavex's website at www.anavex.com. With us today is Dr. Christopher Missling, President and Chief Executive Officer; and Sandra Boenisch, 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 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'd like to turn the call over to Dr. Missling.

Christopher Missling: Thank you, Clint. We appreciate everyone joining us on today's conference call to review our most recently reported financial results and to provide our business update. We are excited with the continued advancement of our lead product candidate ANAVEX 2-73 in Alzheimer disease and Rett syndrome as we maintain our attention on execution across each of our clinical programs, and overall business operations. We were very pleased to present top line data of the randomized double-blind placebo controlled Phase 2b/3 study for the treatment of early Alzheimer disease at the CTAD Congress 2022 on December 1. The trial met both co-primary and secondary endpoints showing statistically significant reduction of clinical decline as measured by those endpoints.

We are excited about the data and plan to submit the data for publication and peer reviewed medical journal in the near term. As a reminder, Alzheimer disease represents a growing burden to healthcare systems and societies worldwide. This disease is often multifactorial, and complex in nature. We believe that our precision medicine platform and novel central nervous system mechanism improve the chance of clinical success. We are pleased by the results of the placebo-controlled Phase 2b/3 Alzheimer disease trial, which data suggests that ANAVEX 2-73 blarcamesine, an orally available small molecule activator of the upstream sigma-1 receptor is pivotal to restoring neural cell homeostasis and promoting neuroplasticity and might be at the forefront of biomarker guided pathway based targeted precision medicine drug development.

louis-reed-pwcKF7L4-no-unsplash

We look forward to presenting the complete data set of the study as well as the other long-term study data of the other programs, including Parkinson disease, Dementia and Rett syndrome. With a deep portfolio of promising therapies, we believe that Anavex remains well positioned to address the urgent needs of patients affected by neurodegenerative in rare neurodevelopmental diseases. Going back to the Rett syndrome program, we announced recently on February 2 last week, the completion of enrollment of the randomized placebo-controlled EXCELLENCE Phase 2/3 study for the treatment of pediatric patients with Rett syndrome. We expect to announce top-line results from this study in the second half of this year. In Parkinson's disease Dementia, we are planning to announce the data from the 48-week open-label extension of the previously successfully completed Phase 2 study.

In other indications, recent communication with the FDA confirms our strategy to advance ANAVEX 2-73 for the treatment of Fragile X syndrome. We plan to initiate this trial soon, and we'll share more details about this clinical program in the near term as it becomes available. Further, pipeline expansion of the Anavex platform using gene biomarkers of response applying precision medicine of neurological disorders is expected, including planned initiation of an ANAVEX 2-73 imaging-focused Parkinson disease clinical study sponsored by the Michael J. Fox Foundation, a planned initiation of our Phase 2/3 three clinical trial for the treatment of a new rare disease indication and the planned initiation of ANAVEX 3-71 Phase 2 clinical trial for schizophrenia.

And last but not least, we expect several clinical publications involving ANAVEX 2-73 and ANAVEX 3-71 and a Rett syndrome burden of illness study. 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.

Sandra Boenisch : Thank you, Christopher, and good morning to everyone. We continue to demonstrate operating fiscally responsibly. During our first fiscal quarter, general and administrative expenses were $3.3 million, compared to $3.1 million for the comparable quarter of fiscal 2022. Our research and development expenses for the quarter were $12.1 million as compared to $8.7 million for the comparable quarter of fiscal 2022. Overall, we reported a net loss of $13 million or $0.17 per share, inclusive of $5.3 million in non-cash compensation items. Our cash position at December 31, 2022, was $143.6 million. During the quarter, we utilized cash and cash equivalents of $5.8 million to fund our operations. At our current cash utilization rate, we believe we have sufficient cash runway to fund operations and clinical programs beyond the next four years, consistent with guidance in previous quarters.

The increase in research and development expenses over the comparable period is primarily related to the expansion of our team and an associated increase in compensation and non-cash charges period-over-period as well as costs associated with our Phase 2b/3 study, ANAVEX 2-73-AD-004, and the manufacture of additional clinical trial supply for upcoming pipeline programs. Thank you. And now back to you, Christopher.

Christopher Missling : Thank you, Sandra. This is an exciting time for the company, and we remain on track for completion and readout of ongoing clinical trials and initiation of additional biomarker-driven precision medicine clinical trials as planned. I would like now to turn the call back to Clint for Q&A.

A - Clint Tomlinson : Thank you, Christopher. We will now begin the Q&A session The first question is going to come from Soumit Roy at Jones Research. You can go ahead, Soumit.

See also 10 Hot Insurance Stocks To Buy Now and 15 Best Dividend Leaders to Buy.

To continue reading the Q&A session, please click here.