Anavex Life Sciences Corp.

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, please use the Q&A box or raise your hand. Please note that 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 current information and expectations and involve a number of risks and uncertainties. We encourage you to review the company's filings with the SEC that include, 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. This conference call discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety, and there is no guarantee that any investigational uses of such products will successfully complete clinical development or gain health authority approval. And with that, I would like to turn the call over to Dr. Misson.

thank you clint and good morning everyone thank you for being with us today to review our q4 financial results and quarterly business update we are fully committed to bringing oral black carmesine and oral anavex 371 to patients We are dedicated to delivering on the value of our pipeline and maximizing its potential for patients, investors, and our employees. Over the coming months, we will continue to focus on progressing our clinical trials and regulatory actions. At the same time, we're aiming to expanding our collaborative initiatives and strategic partnership activities. As previously announced through our update on the status of the regulatory filing of black carmesine in Europe, we expect the CHMP to adopt a negative opinion on the MAA at its December meeting. We intend to request a re-examination of the CHMP opinion upon its formal adoption based on feedback and continued guidance from the CHMP, EMA and the Alzheimer's disease community. DMA procedures adopted by the CHMP allow an applicant to request re-examination of its decision, which would be undertaken by a different set of reviewers that conduct a new examination, independent from the first opinion. Our expert advisors, investigators, as well as patients and their caregivers encourage us in our commitment to continue working in partnership with global regulatory bodies to advance science and potentially new treatment options for patients and their families. As part of the MAA review process, we have successfully undergone a full good clinical practice GCP inspection of the trial data by EMA. The manufacturing package has passed the EMA review as well. A good clinical practice GCP inspection is an official review by a regulatory authority over clinical trials documents, facilities, records and other resources to ensure compliance with GCP guidelines. We are looking forward to working closely with EMA and other stakeholders to advance our investigational therapy for early Alzheimer disease. Importantly, we also announced that we had initial contacts with the authorities in the US regarding our Alzheimer's disease program and we intend to provide further updates on our interaction with the FDA as they become available. Going forward, we will provide both regulatory and clinical trial updates on Blacambizine in other indications such as Parkinson's disease, Rett syndrome and Fragile X. This will include the disclosure of planned future clinical trial designs as we continue to advance our therapeutic pipeline. During the most recent quarter, we announced several new scientific and medical publications which includes a peer-reviewed publication in the journal Neuroscience Letters, titled Prevention of Memory Impairment and Hippocampal Injury with Blacarmesine in an Alzheimer's Disease Model. This study shows that pretreatment with Blacarmesine prevented amyloid beta-induced memory impairment. and brain oxidative injury, suggesting that Blakamsin is an attractive candidate for Alzheimer disease pharmacological prevention. A peer-reviewed publication in the journal iScience ascertaining the precise autophagy mechanism of SIGMA-1 receptor through Blacarmesine activation, titled Conserved LIR-Specific Interaction of SIGMA-1 Receptor in GABA-Rub. A publication Oral Blacarmesine Phase 2b-3 Trial confirms identified precision medicine patient population significant broad clinical and quality-of-life improvements for early Alzheimer's disease patients to be available online as a preprint and in submission to a peer-reviewed medical journal. Anavex announced the latest published scientific results for Blacarmazine on all standard scales for measuring Alzheimer's disease and cognitive decline after 48 weeks The defined precision medicine population, ABCLIR3, consisting of early Alzheimer's disease patients with confirmed and progressed pathology, taking 30 mg once daily oral blaccharmazine, demonstrated barely detectable decline. This was comparable to minimally perceptible decline in prodromal, which is pre-dementia aging with adults. On October 29, we announced additional long-term clinical data for Blacarmazine. This new data demonstrated continued long-term benefit from oral Blacarmazine compared to decline observed in the Alzheimer Disease Neuroimaging Initiative Control Group, also called ADNI, a control group established by a clinical research project launched by NIH in 2004. In the intent-to-treat population, significantly less cognitive decline was observed for the black carmesine participants compared to the ADNI control group at 48 weeks, with a significant and clinically meaningful difference in mean change from baseline at a Coq13 total score of minus 2.68 points. Over the course of the open label extension study at time point 96 weeks, these two groups further diverged sharply with statistical significant differences in mean change in ADAS-COG 13 total score at 96 weeks of minus 6.41 points. The difference between groups continues to increase at 144 weeks to ADASCOG13 total score difference of minus 12.78 points. The results provide evidence of the significant beneficial therapeutic effect of black carmesine, which positively separates from the ADNI control group with duration of treatment. This significant beneficial therapeutic effect of Blacarmazine compared to decline observed in the ADNI control group translates into 17.8 months of time saved with oral Blacarmazine, allowing for longer independence of the patients by approximately over 1.5 years. Looking ahead, Anavex will be presenting additional data and scientific findings at upcoming conferences and in publications. These include the direct relationship between cognitive function and reduced brain region atrophy with black carmesine. oral black carmesin for early symptomatic Alzheimer's, robust effect size through precision medicine, and analysis of the Anavax 273 AD-004 randomized trial. Also, newly identified precision medicine gene, collagen 24A1, with over 70% prevalence, which establishes effective treatment of early Alzheimer's disease with black carmesine. And also, continued long-term benefit from oral black carmesine compared to delayed start analysis and decline compared to natural history studies. With regard to Anavex 371, in October, Anavex announced positive top-line results from its placebo-controlled Phase 2 clinical study, evaluating Anavex 371 for the treatment of schizophrenia in adults on stable antipsychotic medication. The study successfully achieved its primary endpoint, demonstrating that Arnavix 371 was safe and well tolerated. The safety profile was consistent with previous studies of Arnavix 371 in healthy volunteers, with no serious or severe treatment emergent adverse events reported in either Part A or Part B of the study. In addition to meeting the primary safety endpoint, secondary and exploratory analysis revealed encouraging trends in several outcome measures. Our other oral medicine candidate, Anavex 371, represents, therefore, a transformative opportunity in neuropsychiatric drug development. leveraging its unique dual sigma-1 agonist M1-PAM mechanism to address multiple high-value indications through a unified neuroinflammatory biomarker platform. Further detailed analysis of randomized, strictly double-blind and placebo-controlled clinical trial Anavex 371-SZ001 revealed very encouraging data in patients suffering from schizophrenia. Following successful Phase 2 results from the SZ001 study, while confirming the accident safety profile of Anorex 371, the study demonstrated reduction in GFAB and YLK40 neuroinflammatory markers. as a structural protein of astrocytes in the brain represents aberrant activation of astrocytes, the major brain glial cell lineage. Astrocytes participate in brain neural function in multiple ways. Amongst them, critical modulation of synaptic relay between neurons in neural circuits. Its dysfunction, a key pathogenesis mechanism in schizophrenia. This positions Anavex 371 to advance into pivotal trials with the once daily modified release oral tablet, enabling once daily dosing across depression and psychosis indications, where current therapies have failed or shown limited efficacy. In addition to schizophrenia, one high unmet need opportunity would be depression in Alzheimer disease, with currently no approved therapies. Up to 40% of people with Alzheimer experience significant depression, especially in early and middle stages of the disease. Depression in Alzheimer is associated with worse quality of life, accelerated cognitive decline and earlier onset of dementia symptoms. The neuroinflammatory biomarker strategy positions Anavax 371 to potentially achieve disease modification claims beyond symptomatic treatment, representing a paradigm shift in neuropsychiatric drug development. And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavax for a financial summary of the recently reported quarter.

Thank you, Christopher, and good morning to everyone here. I'm pleased to share with you today our fourth quarter financial results for our 2025 fiscal year. Our cash position on September 30th was $102.6 million, and we had no debt. During the quarter, we utilized cash and cash equivalents of $8.6 million in our operating activities after taking into account changes in non-cash working capital accounts. As of today, with the current cash balance of over 120 million, we anticipate that at the current cash utilization rate, our cash runway is more than three years. Our research and development expenses for the quarter were 7.3 million, as compared to 11.6 million in the comparable quarter of last year. General and administrative expenses were 3.5 million, as compared to 2.7 million for the comparable quarter of last year. Compared to the same quarter of fiscal 2024, we saw a decrease in operating expenses, mostly driven by the completion of a large manufacturing campaign of Blark-Hamazine and a decrease in clinical trial activities as a result of the completion of our open label extension studies and our Anavex 371 phase two study in schizophrenia. And lastly, we reported a net loss of 9.8 million for the quarter, which is 11 cents per share. Thank you, and now I will turn the call back to Christopher.