Anavex Life Sciences Corp.

Good morning, and welcome to the Anovex Life Sciences Fiscal 2024 Third 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 this conference is being recorded, and 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 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.

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 continue to meaningfully advance our differentiated precision medicine clinical program, highlighted by the recent presentation of comprehensive results from the Phase IIb-III clinical trial, Blacarmazine, 1 of X273, which were presented at the Alzheimer's Association International Conference, AAIC, showing that oral, once daily, black carmesine significantly slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and or associated neuroimaging adverse events. Full data from the black carmesine study in Alzheimer's disease phase 2B-3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal. The initiated process for submitting a marketing authorization application, MAA, to the European Medicine Agency, EMA, under the centralized procedure is underway, with full regulatory submission of Placarmazine expected in Q4 of 2024. The marketing authorization would allow direct market access throughout the European Union for oral black carmesine for the treatment of Alzheimer's disease. There are an estimated 7 million people in Europe with Alzheimer's disease, a number expected to double by 2030, according to the European Brain Council. Analysis of RNA sequencing, RNA-seq, which would reveal which genes are actively transcribed, or in other words, expressed in Alzheimer patients, in comparison between placebo and placarmazine of the placebo-controlled phase 2b-3 placarmazine trial in early Alzheimer disease, is underway. This data... might have relevant value since it may provide insight into Alzheimer disease pathology and how cells function in the presence of placebo or in the presence of lacamycin, respectively. Interim data is expected in the second half of 2024. In June, we completed the last patient last visit in the AttentionAD open label extension 96-week trial. Interim data from this trial is expected in the second half of 2024. The recent AAIC24 meeting resulted in constructive feedback, coupled with enthusiasm around our Alzheimer's disease program, strengthened by the recent addition of an experienced clinical team, which support Anavec's future plans. Educational outreach will continue as we work towards MAA submission and beyond. We are also pleased to report that the clinical team continues to beat the planned timelines in the ongoing phase two clinical trial of ANOVAX371 in schizophrenia patients. We have completed dosing of the first cohort and are mirroring the completion of enrollment of the second cohort of schizophrenia patients in path A of the trial. In Parkinson's disease, initiation of Anavex 273 phase 2B-3, a over six months trial, including biomarkers, which we believe may be key for understanding drug effects on Parkinson's disease pathology and account for the recently changing context in the field of Alzheimer's disease, of Parkinson's disease, is expected in the second half of 2024. In Rett Syndrome, an educational presentation was provided at the 2024 IRSF Rett Syndrome Scientific Meeting going from June 18 to June 19, 2024, which demonstrated the commitment of ARVEX to the Rett Syndrome community through direct engagement with patients and families. Positive and supportive feedback was received from families and investigators about the continued Anavax RAD syndrome program. Regarding Fragile X, new disease-specific translatable and objective biomarker data generated with Anavax 273 supporting the initiation of the Anavax 273 phase 2-3 clinical trial was presented at the 19 NFXF International Fragile X Conference. Meeting with the NF-FXF leadership team strengthened Anavec's relationship with the community, coupled with an increased awareness of Anavec's Fragile X Syndrome program by engaging with patients and families in attendance. We are also expecting the initiation of Anavec's 3 Phase 2-3 clinical trial in a new rare disease in the future. Finally, we are building medical affairs capabilities to expand education and physician support activities to ensure optimal medical impact, including continued clinical publications involving Annex 273 and Annex 371. And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Annex for a financial summary of the recently reported quarter.

Thank you, Christopher, and good morning to everyone. I am pleased to share with you today our third quarter financial results for our 2024 fiscal year. Our cash position at June 30th was $138.8 million, and we have no debt. During the quarter, we utilized cash and cash equivalents of $5.2 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 a cash runway of approximately four years. During our most recent quarter, general and administrative expenses were $2.9 million as compared to $2.8 million for the immediately preceding second quarter. Our research and development expenses for the quarter were $11.9 million as compared to $9.7 million for the immediately preceding second quarter. And lastly, we reported a net loss of 12.2 million for the quarter, which is 14 cents per share. Thank you, and now back to you, Christopher.