5/10/2022

speaker
Clint Tomlinson
Conference Call Host

Good afternoon. Welcome to the N of X Life Sciences Fiscal 2022 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 will conduct a question and answer session. 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 Anavex's website at www.anavex.com. With us today is Dr. Christopher Misling, President and Chief Executive Officer, and Sandra Bonish, 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 the 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 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 would like to turn the call over to Dr. Misling.

speaker
Dr. Christopher Misling
President and Chief Executive Officer

Thank you, Clint. We appreciate everyone joining us today, conference call, to review our most recently reported financial results and to provide a business update. We are pleased with the continued advancement regarding our lead product candidate Anavex 273 in Alzheimer's disease and Rett syndrome as we maintain our attention on execution across each of our clinical programs and overall business operations. In the second half of 2022, we are expecting two pivotal top-line results readouts, including top-line results from the randomized placebo-controlled phase 2B-3 study, ANAVEX 273AD004, for the treatment of Alzheimer's disease, and from the randomized placebo-controlled excellence phase 2-3 study, ANAVEX 273RS330, for the treatment of patriotic patients with Rett syndrome. Next month, Anavex will host our R&D day for investors and analysts on Tuesday, June 21st, 2022. This R&D day will include presentations from the company's leadership team with a focus on the company's clinical development pipeline. Additional details will follow closer to the event. In July, a oral presentation of effects of the SIGMA-1 receptor agonist, Blacamecine , in a murine model of Fragile X syndrome, neurobehavioral phenotypes, and receptor occupancy will be presented at the 18th NFX-XF International Fragile X Conference, July 14 to 17, 2022, taking place in San Diego, California. Further pipeline expansion of the ANOVAX platform using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need is expected in 2022, including meeting with the FDA to discuss the ANOVAX273 Parkinson disease program, including a pivotal phase three study. Planned initiation of a Anavex 273 imaging-focused Parkinson's disease clinical study sponsored by the Michael J. Fox Foundation. And a planned initiation of a potentially pivotal phase 2-3 study in Fragile X, the most frequent genetic cause of autism spectrum disorder. and a planned initiation of a phase 2 slash 3 clinical trial for the treatment of a new rare disease indication, and planned initiation of ANAVEX 371 phase 2 clinical trial for frontal temporal dementia, schizophrenia, and Alzheimer's disease indications. 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.

speaker
Sandra Bonish
Principal Financial Officer

Thank you, Christopher, and good afternoon to everyone. During the quarter ended March 31, 2022, we continued to maintain fiscally responsible cash utilization as we expand and advance our pipeline. Our cash position at March 31, 2022, was $153.3 million, which we believe is sufficient cash runway to fund our operations and our clinical programs beyond the next four years. Our research and development expenses for the second quarter of fiscal 2022 were 8.6 million as compared to 6.7 million for the same quarter of fiscal 2021. General and administrative expenses were 2.9 million compared to 2.2 million in the comparable quarter of 2021. Overall, we reported a net loss of 10.4 million for the quarter, which is 14 cents per share. The overall increase compared to the previous year period is primarily related to an increase in non-cash compensation charges, period over period, which is driven by the addition of staff to manage and support our clinical studies and development. Thank you, and I'll turn the call back over to you, Christopher.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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