Anavex Life Sciences Corp. (AVXL) Earnings Call Transcript & Summary

Welcome to the Anavex Life Sciences Corp. Business Update Conference Call. [Operator Instructions] I would now like to turn the conference over to Alex Arzeno with SCR Investor Relations. Please go ahead.

Hello, everyone, and thank you for joining us on the call today. Before we begin, let me remind you that we will make forward-looking statements on this call, and actual results may differ materially from those expressed or implied in these statements. These statements are made as of today, September 9, 2026, and we undertake no obligation to update them, except as required by law. Please refer to our SEC filings for a detailed discussion of the risks and uncertainties affecting our business. I will now turn the call over to the Chair of the Board of Directors for Anavex Life Sciences, Dr. Jiong Ma. Jiong, please go ahead.

Thank you, Alex. Hello, everyone. I have had privilege of serving as Board Chair at Anavex since 2023, but I have been part of the Board of Directors since 2021. There is a shared passion among all of us at Anavex, the Board, management, and employee. That is to advance blarcamesine ANAVEX 2-73 forward to help patients, families, communities suffering from central nervous system diseases with high unmet medical needs. On behalf of the Board, we would like to thank everyone for their continued support and understanding during this critical transition period. We were able to file our 10-Qs in late August. Now we're back in compliance with Nasdaq. We are excited to conduct a brief call today to outline the company's path forward on all three indications: Alzheimer's, Rett syndrome, and Fragile X syndrome. We plan to return to our regular cadence of quarterly conference calls, including Q&A, when we conduct our fourth quarter call in November. Our intent today is to let shareholders hear directly from Dr. Terrie Kellmeyer. Since being named as interim CEO in early May, she and her team have been working diligently and efficiently on our new strategy forward. I will turn the call over to her now.

Thanks, Jiong. It is both a privilege and a responsibility to speak to you today as the interim CEO of Anavex. I have been eager to address our shareholders, and I am excited about the platform given to me today to do just that. I want to be direct about 3 things from the outset: where Anavex stands today, the company's path forward, and the foundation we have to execute our strategy with confidence. Our conviction in blarcamesine has not wavered, and if anything, our confidence has only deepened. We stand firmly behind blarcamesine's potential, and the scientific evidence continues to support a promising path forward. We acknowledge there was a delay in the company's second and third quarter 10-Qs, which was the result of the termination of our former CEO and the ensuing review by the Special Committee. As a result of that review, management, in consultation with the Audit Committee of the Board, reassessed the effectiveness of the company's disclosure controls and procedures and its internal control over financial reporting as of our fiscal year ended September 30, 2025. We concluded that certain deficiencies constitute a material weakness, and as a result, we also concluded that our disclosure controls and procedures were not effective. We have developed a remediation plan that will be overseen by our Audit Committee. The plan is further detailed in our Form 10-K/A filed on August 28. We are now current in our SEC reporting obligations, and we were pleased to receive official confirmation from Nasdaq last week that the company has regained compliance with Nasdaq rules. This is a strategic pivot point for the company, and going forward, we will be executing against a clear, focused development plan. I have spent my entire career in drug development. Over nearly 3 decades, I have built and led clinical and regulatory functions across the full life cycle of drug development, from IND through approval and commercialization, at companies large and small, across multiple therapeutic areas. I understand how to work collaboratively with regulators, how to build a strong and regulatory-compliant scientific and clinical plan, and how to lead the team to execute it. That is the experience that I have been bringing to bear each day as we are charting a path forward for blarcamesine. Now onto the science. I have spent the last several years immersed in the science and clinical data behind blarcamesine ANAVEX 2-73, our oral sigma-1 receptor agonist and lead investigational asset. The sigma-1 receptor modulation is a biologically plausible mechanism with relevance across neurodegeneration and neurodevelopment, and the data generated to date have given us reason to continue investigating blarcamesine across Alzheimer's disease, Rett syndrome, and Fragile X syndrome. I know this program intimately: its strengths, its data, and I know what is needed to advance it. Advancing blarcamesine for the treatment of early Alzheimer's disease is our top priority, and our focus is now on engagement with the FDA to align on a clear U.S. regulatory path. We have taken the regulatory feedback we recently received from the EMA as constructive guidance, and we are incorporating it into our planned discussions with the FDA regarding our Phase III study design and the overall development program for blarcamesine. Our goal is to now achieve a strong, well-aligned study design across both regulatory agencies. I'd also like to mention that we recently refreshed and streamlined our Scientific Advisory Board. We now have a focused group of Alzheimer's disease key opinion leaders and treating physicians to help us advance our lead program forward. As Jiong mentioned, we have also committed to 2 other indications that we believe have the greatest chance for success: Rett syndrome and Fragile X syndrome. With the FDA having already granted Orphan Drug Designation, Rare Pediatric Disease Designation, and Fast Track Designation for blarcamesine in Rett syndrome, we believe we have a solid foundation to move forward with initiating a Phase III study for adult participants, while working with the FDA in parallel to align on the inclusion of pediatric participants. In fact, I'm happy to announce that we've just heard back from the FDA, and we have been granted a meeting with the agency to discuss adding our pediatric population to our Phase III study. This is great news and progress toward our overall goal of aligning with the FDA on all of our programs. When looking at the Fragile X program, we believe in the potential here. We have begun allocating resources to our Fragile X clinical program. The IND for Fragile X syndrome is expected to be submitted in the next couple of weeks and will be supported by the Orphan Drug Designation already granted by the FDA. We've heard questions from investors about the status of our programs for schizophrenia and Parkinson's disease. We have paused development on these indications, and given our cash on hand, and to be fiscally responsible, we've decided to focus our resources on the programs that we believe have the greatest potential for success, which are the 3 core indications we have laid out. We believe this is the strongest strategy to create long-term shareholder value. Our mandate is straightforward: focus the company, apply rigorous discipline, and let the data lead every decision, while providing transparent updates on the progress being made across all 3 indications. Anavex enters this next phase with a strong cash balance and no long-term debt. We expect to be disciplined stewards of capital, investing where the science and regulatory pathway are clearest, building the right team to support our programs, and focusing on the opportunities that we believe will create long-term value for shareholders. We will move in an efficient and effective manner, putting our cash toward activities that we believe will yield results that will make us an attractive investment and potential partner. To support our endeavors, we plan on attending scientific conferences, as noted in our third quarter earnings press release. We are also beginning to build out an investor conference calendar to engage with the appropriate audiences. Next, I want to take a moment to speak directly to our long-term shareholders, as well as our covering analysts and partners. Many of you have supported Anavex through years of hope, uncertainty and disappointment, and you have never lost your belief in the underlying mission of this company. I know that the communication you received in the past felt incomplete, overly optimistic, or disconnected from the level of detail you deserved as supporters of the company. I want to be direct with you. That is not the standard we intend to operate by going forward. We intend to earn back your trust through clear communication, decisive action, and a strategy built around giving our programs the best chance of reaching patients. That starts with a credible regulatory road map. We are committed to giving you a clear view of how we are prioritizing resources, time lines, regulatory interactions and next steps across our programs and the jurisdictions in which we operate. We will avoid ambiguity, overstatement, and unexplained silence and we will not leave you guessing about the status of our programs. Even when the news is difficult, you should expect direct and disciplined communication from this team, delivered candidly, confidently, and with humility. Above all, we are holding ourselves to a new standard of accountability, transparency, statistical rigor, strategic openness, and respect for our shareholders. We firmly believe that we can right this ship. I now want to take a moment to recognize the team at Anavex. Through a period of significant uncertainty, our people have continued to show up, support the science, conduct rigorous clinical work, truly demonstrating the commitment we all have to the company's future. That kind of dedication is not something you can manufacture. It reflects a genuine belief in what we are doing, and why it matters. I am proud to lead a team of talented individuals who remain focused on the work, even when the path is not easy, and I am committed to earning and sustaining their trust as we move forward together. In addition to our talented internal team, we are actively building our leadership team with experienced leaders with relevant clinical trial and regulatory experience to support our goals. At the heart of everything we do are the people we are working for. Nearly all of us have been touched in some way by Alzheimer's disease, be it a parent, a grandparent, a neighbor, or a friend. We understand the particular heartbreak of watching someone you love slowly become unreachable. For families living with rare diseases like Rett syndrome and Fragile X syndrome, the challenges are no less profound. These are often children, and the parents and caregivers who love them are counting on the science to move faster, to do better, and to not give up. We take that responsibility seriously; it is not an abstraction for us. It is the reason we come to work. The patients living with Alzheimer's disease, Rett syndrome, and Fragile X syndrome deserve a company that is focused, honest, and relentless, and that is what I intend to deliver. In closing, we appreciate all participants taking the time to listen in on our call today. We will be speaking to the market again on our 2026 fiscal fourth-quarter and year-end earnings call in November. Here, we will provide a more comprehensive update on our progress and go into more detail on future milestones. In the meantime, we will update the market with any material progress via press releases. Please do not hesitate to contact our Investor Relations team with any questions, comments, or concerns. They are received, read, and reviewed. Thank you.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.