Anavex Life Sciences Corp. (NASDAQ:AVXL) Q4 2022 Earnings Call Transcript
Anavex Life Sciences Corp. (NASDAQ:AVXL) Q4 2022 Earnings Call Transcript November 28, 2022
Anavex Life Sciences Corp. misses on earnings expectations. Reported EPS is $-0.18 EPS, expectations were $-0.16.
Clint Tomlinson: Welcome to the Anavex Life Sciences' Fiscal 2022 Fourth 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.
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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.
Dr. 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 a business update. We are excited with a 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 are planning to present top line data of the randomized, double-blind, placebo-controlled Phase 2b/3 study ANAVEX 2-73-AD-004 for the treatment of early Alzheimer disease in a late breaking oral presentation at the upcoming clinical trials on Alzheimer disease, CTAD Congress 2022 on December 1, 2022 at 4:30 PM Pacific Time in San Francisco, California.
In our Rett syndrome program, we are nearing completion of the randomized, placebo-controlled EXCELLENCE Phase 2/3 study for the treatment of paediatric patients with Rett syndrome. We expect to update on the complete enrollment accordingly. Earlier this month, we announced that the FDA granted Orphan Drug Designation to ANAVEX 2-73 for the treatment of Fragile X syndrome. Fragile X syndrome is the most common form of inherited intellectual disability and the most frequent single gene cause of autism spectrum disorder with an estimated population of approximately 62,500 in the U.S. and over 1 million worldwide. Recent guidance received from the FDA confirms our strategy to advance ANAVEX 2-73 for the treatment of Fragile X syndrome in our double-blind, randomized, placebo-controlled Phase 2/3 development program.
We will share more details about this clinical program as it becomes available. In August, we reported a relevant new peer-reviewed publication in the journal Science Translational Medicine titled Widespread cell stress and mitochondrial dysfunction occurs in patients with early Alzheimer disease. This publication provided further scientific evidence of the relevance of sigma-1 receptor activation as a compensatory mechanism to chronic CNS diseases. Further pipeline expansion of the Anavex platform using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need is expected, including; meeting with the FDA to discuss the ANAVEX 2-73 Parkinson disease program, including a pivotal Phase 3 study; a planned initiation of ANAVEX 2-73 imaging-focused Parkinson disease clinical trial sponsored by the Michael J.
Fox Foundation; a planned initiation of a Phase 2/3 clinical trial for the treatment of a new rare disease indication; and a planned initiation of ANAVEX 3-71 Phase 2 clinical trial for schizophrenia. 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.
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Sandra Boenisch : Thank you, Christopher, and good morning, everyone. During our fourth fiscal quarter, we reported a net loss of $14.3 million or $0.18 per share. The reported net loss includes $6 million in non-cash items. Our research and development expenses for the quarter were $11.4 million as compared to $9.4 million for the comparable quarter of fiscal 2021. General and administrative expenses were $3.9 million compared to $2.9 million for the comparable quarter of fiscal 2021. Our cash position on September 30, 2022 was $149.2 million. During the full fiscal year 2022, we utilized cash and cash equivalence of $24.2 million to fund our operations. Within our current cash utilization range, we believe we have a sufficient cash runway to fund operations and clinical programs beyond the next four years.
The overall increase in expenses over the comparable period is primarily related to the expansion of our team, and an associated increase in non-cash charges period over period. Thank you. And now, I'll return the call back to you, Christopher.
Dr. Christopher Missling : Thank you, Sandra. This is an exciting time neuroscience and rare disease drug development, and we remain on track for the readout of the placebo-controlled ANAVEX 2-73 Phase 2b/3 Alzheimer disease clinical trial, a condition of significant unmet need and economic burden for which there are only limited approved pharmacological treatment options, as well as initiating biomarker-driven precision medicine clinical studies as planned. I would like now to turn the call back to Clint for Q&A.
A - Clint Tomlinson: Thank you, Chris. We'll now begin the question and answer session. And our first question is coming from Charles Duncan from Cantor Fitzgerald.
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