5/9/2024

speaker
Clint Tomlinson
Conference Call Host

Good morning, and welcome to the Anovex Life Sciences Fiscal 2024 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, and during this session, if you would like to ask a question, 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 is Dr. Christopher Misling, President and Chief Executive Officer, and Sandra 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 SCC. This includes without limitation the company's forms 10K and 10Q, 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 would like to turn the call over to Dr. Mislan.

speaker
Dr. Christopher Misling
President and Chief Executive Officer

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. We are encouraged by the very recently issued FDA guidance for early Alzheimer's disease, which states that one cognitive measures alone, like others COG, could be a sufficient primary endpoint for early Alzheimer's disease. We appreciate this new guidance and believe this opens another possible pathway for us to move forward in parallel to the initiated process of market authorization application to the European Medicine Agency, EMA, for Blacarmazine for the treatment of Alzheimer's disease. which are already underway. Full data from the Blacarmazine study in Alzheimer's disease phase 2B-3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal. As well, analysis of RNA sequencing of the trial is underway, and interim data is expected by mid-2024. Concurrently, the AttentionAD open label extension trial is ongoing, and we expect to be able to share interim data in the second half of 2024. In RAD syndrome, continued positive real-world evidence feedback from RAD syndrome patients and caregivers participating in the ongoing open-label extension trial and compassionate use program for patients who participated in the excellence trial encourages us to continue our partnership with the RAD syndrome community and to proceed with a phase 3 12-week efficacy study. An educational presentation will be provided at the 2024 IRSF Rett Syndrome Scientific Meeting taking place this year, June 18 to 19, 2024. Regarding Parkinson's disease, initiation of a ANAVEX 273 Phase IIb-III six-month trial is expected in the second half of 2024. In Fragile X, new specific translatable and objective biomarker data generated with Anavex 273 supporting the initiation of the potentially pivotal Anavex 273 phase two slash three clinical trial will be presented at the 19th National Fragile X Foundation Conference taking place in July 25th to July 28th, 2024. Related to a new rare disease, we are also in preparation to initiate a potentially pivotal Anavax 273 phase two slash three trial. With respect to Anavax 371, we are quite pleased to provide an update that the placebo controlled phase two clinical trial of Anavax 371 for the treatment of schizophrenia. The study is well underway with the first cohort of schizophrenia patients being fully enrolled. We are also expecting further peer-reviewed clinical publications involving both Anavex 273 and Anavex 371. And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex, for a financial summary of the recently reported quarter.

speaker
Sandra Boenisch
Principal Financial Officer

Thank you, Christopher, and good morning to everyone. I'm pleased to share with you today our second quarter financial results for the 2024 fiscal year. Our cash position at March 31st was $139.4 million. During the quarter, we utilized cash and cash equivalents of $11.7 million in operating activities after taking into account changes in non-cash working capital accounts. At our current cash utilization rate, we believe we have cash runaway approximately four years. During our most recent quarter, our general administrative expenses were 2.8 million as compared to 2.6 million in the immediately preceding first quarter. Our research and development expenses for the quarter were 9.7 million as compared to 8.7 million for the immediately preceding first quarter. And lastly, we are reporting a net loss of 10.5 million for the quarter or 13 cents per share. And thank you. Now back 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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