5/13/2025

speaker
Clint
Conference Operator

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 the session, if you'd like to ask a question, please use the Q&A box or raise your hand. Please note this conference is being recorded, and 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 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 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 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. 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. Our portfolio of non-invasive targeted upstream precision compounds continues to advance with special focus on Alzheimer's disease and schizophrenia. We also continue to receive feedback from neurologists preferring convenient, orally available and clinically meaningful Alzheimer's disease treatment options, which can be assessed without logistical restrictions. In April, we were pleased to present open-label extension data of Blacar-Mezin for Alzheimer's disease at the ADPD 2025 conference. The data confirmed continued clinically meaningful benefit for early Alzheimer's disease patients. Once daily oral Blacarmazine demonstrated over three years of continuous treatment significant amelioration on clinical decline and shown continued clinically meaningful benefit for early Alzheimer's disease patients. Blacarmazine treated patients continued to accrue benefit through up to four years, as measured by the clinical endpoints ADAS-COG-13 and ADCS-ADL. Last month, Marwan Sabak, professor of neurology at Baroneurological Institute and chairman of Anavex's Life Sciences Advisory Board, gave an oral presentation titled, Oral Plaquamycin, Novel Mechanism for Alzheimer Disease. autophagy restoration through upstream SIGMA-1 activation, clinical efficacy phase 2b-3 trial, at the 9th International Conference on Alzheimer's Disease and Related Disorders in the Middle East. The meeting convened a wide range of healthcare professionals and community advocates from the Middle East and North Africa, USA, Europe, and other countries with an interest in epidemiology, clinical research, medicine, basic science, and healthcare advocacy related to Alzheimer's disease and related disorders in the region, specifically with an emphasis on region-specific healthcare delivery. With respect to schizophrenia, earlier this month we announced the successful completion of enrollment in our Phase 2 clinical study of Anavix 371 for the treatment of schizophrenia. The study has enrolled a total of 71 participants, with 16 participants in Part A and 55 participants in Part B. Part A of the study, which investigated multiple ascending doses, has been completed with encouraging preliminary safety and electroencephalography results, previously reported. Part B, which includes more participants and with a longer treatment duration, will provide more comprehensive clinical and biomarker data on the efficacy and safety of Anavex 371 in individuals with schizophrenia. We expect to report top-line data from the study in the second half of this year. Since our last update, we also expanded our scientific advisory board. In April, we announced the appointment of Professor Dr. Audrey Gabel, a specialist of predictive personalized medicine and digital healthcare in Alzheimer's disease and related disorders. to the ANAVEC Scientific Advisory Board. Dr. Cabell is a professor of neurology, neurologist and doctor in neurosciences at the Memory Resources Research Center, the Rare and Early Dementia Reference Center and the European Neurodegenerative Excellence Center of Montpellier University, France. Dr. Keppel is also a researcher at the Montpellier Institute of Neurosciences and member of the European Alzheimer Disease Consortium. And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Annevex, for a financial summary of the recently reported quarter.

speaker
Sandra Burnish
Principal Financial Officer

Thank you, Christopher. Good morning to everyone. I'm pleased to share with you today our second quarter financial results for our 2025 fiscal year. Our cash position on March 31st was $115.8 million and we had no debt. During the quarter, we utilized cash and cash equivalents of $5.9 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 ranges, a runway of approximately four years. During our most recent quarter, general and administrative expenses were 2.6 million as compared to 2.9 million for the comparable quarter of last year. Our research and development expenses for the quarter were 9.9 million as compared to 9.7 million for the comparable quarter of last year. And lastly, we reported a net loss of 11.2 million for the quarter, or 13 cents per share. Thank you, and now I will turn the call back over to Christopher.

Disclaimer

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