2/12/2025

speaker
Clint Tomlinson
Host

Good morning, everyone, and welcome to the Anovex Life Sciences Fiscal 2025 First 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, and 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. 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 Sondra Burnish, Principal Financial Officer. Before we begin, please note that 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. Misling.

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. I would like to point out that we are receiving growing support from stakeholders for the potential to advance a novel precision medicine treatment for early Alzheimer's disease with convenient oral dosing and with potential clinical meaningful benefit. We are excited to be potentially making a difference for individuals suffering from Alzheimer's disease by presenting a scalable treatment alternative alongside the ease of oral administration. Last month, we provided top-line, long-term data from the Phase 2b-3 Attention-AD open-label extension trial. The data demonstrated that over three years of continuous treatment with Plaquamizine significantly reduced clinical decline, showing continued clinical meaningful benefit for early Alzheimer's disease patients. Also in January, we announced that the Journal of Prevention of Alzheimer's Disease, JPAT, published a peer-reviewed detailed results from the Phase 2B-3 study, evaluating oral blacarmezine for the treatment of early Alzheimer's disease. one stately oral black carmesine, demonstrating a safety profile with no associated neuroimaging adverse events, significantly slowed clinical progression by 36.3% at 48 weeks with black carmesine group, as well as the pre-specified sigma-1 wild-type gene group by 49.8% at 48 weeks on the pre-specified primary cognitive endpoint, ADAS-COG-13, respectively. The peer-reviewed publication of this data underscores the significance of the findings for both the scientific community and those focused on Alzheimer's disease. Alzheimer's disease is a highly complex condition, and this dataset plays a crucial role in advancing our understanding of the Phase IIb-III results. We are grateful for the dedication from participants, their families and the sites for taking part in this important study. Finally, at the end of January, we announced that ANAVEX was issued a new composition of meta US patent expected to remain in force at least until July 2039 entitled A2-73 Crystalline Polymorph Compositions of Meta and Methods of Use Thereof from the United States Patent and Trademark Office. This new patent claims crystalline forms of the dehydrogen phosphate salt of Anavex 273 freebase, as well as transdermal patches and etheric coded oral dosage forms, including the same for neuroprotection and treatment of neurodegenerative disorders, including Alzheimer's disease, Parkinson's disease, and other disorders. The issuance of this US patent again showcases our expertise in identifying and pursuing novel therapeutic forms and formulations that are rooted in science. With respect to Anavex 371, which will now include more participants at the longer treatment duration within Part B, Anavex expects data from the ongoing Part B of the placebo-controlled Phase II study in schizophrenia in the first half of 2025. And now I would like to direct the call to Sander Boenisch, Principal Financial Officer of Arnavex, for a financial summary of the recently reported quarter.

speaker
Sondra Burnish
Principal Financial Officer

Thank you, Christopher. Good morning, everyone. I'm pleased to share with you today our first quarter financial results for the 2025 fiscal year. Our cash position at December 31st was $120.8 million, and we had no debt. During the quarter, we utilized cash and cash equivalents of $12.1 million in operating activities after taking into account changes in non-cash working capital accounts. As of quarter end, we anticipate at the current cash utilization rate and range a runway of approximately four years. During our most recent quarter, general and administrative expenses were $3.1 million as compared to $2.7 million for the comparable first quarter. Our research and development expenses for the quarter were $10.4 million as compared to $8.7 million for the comparable first quarter. And lastly, we reported a net loss of $12.1 million for the quarter, or $0.14 per share. Thanks, and 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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