Tom Bishop

Tom Bishop inquired about the additional information to be included in the EMA resubmission, specifically regarding Aβ-Clear data, brain volume data, COL24A1, and OLE. He also asked why the existing data couldn't be submitted to the FDA sooner, if any trials are currently in progress, and for a near-term timeline for upcoming trials in schizophrenia, Parkinson's, and Fragile X.

Answer

President and CEO Christopher Missling detailed that the resubmission would include AD-004 study data, open-label study data, Aβ-Clear population data, and correlation of clinical efficacy with brain atrophy reduction, addressing conditional approval requirements. He clarified that FDA submission is in process and requires scheduled meetings. Currently, compassionate use programs for Rett Syndrome and Alzheimer's Disease are ongoing. He confirmed plans to advance studies in Parkinson's Disease, Fragile X Syndrome, schizophrenia, and another undisclosed indication.

Tom Bishop asked for more details on the additional information included in the EMA resubmission for blarcamesine, specifically regarding Aβ-Clear data, brain volume, COL24A1, and Open-Label Extension (OLE) data. He also questioned the timing of FDA data submission and the status and timelines for ongoing and planned clinical trials.

Answer

President and CEO Christopher Missling confirmed that the EMA resubmission would include AD-004 study data, OLE data, Aβ-Clear population data, and correlations between clinical efficacy and brain atrophy reduction, suggesting a re-articulation of the data's strength. He clarified that FDA data submission is in process, pending meeting scheduling. For trials, he stated only compassionate use programs for Rett Syndrome and Alzheimer's are currently ongoing, with plans for Parkinson's disease, Fragile X Syndrome, schizophrenia, and a new Alzheimer's trial (AD006) in the pipeline, but did not provide specific near-term timelines for new trial initiations.

Tom Bishop inquired about the CHMP's guidance on additional biomarker information for Blarcamesine, whether the ABCLEAR data could be included in the re-examination, the potential duration of a conditional trial if EMA approval is granted, Anavex's progress in exploring commercialization options with large pharma, and the mechanism of action for Collagen 24A1.

Answer

President and CEO Christopher Missling clarified that the CHMP seeks demonstration of Blarcamesine's benefit outweighing risks, suggesting objective biomarkers like brain atrophy could be helpful. He noted that Blarcamesine demonstrated less or halted brain shrinking, an objective marker of neurodegeneration, and that correlation between reduced atrophy and cognitive improvement would be presented. He emphasized the compelling clinical meaningful and significant improvements across various endpoints (CGI, quality of life, PIQ, MMSE, ADAS-Cog13, CDR-Sum of Boxes, ADCS-ADL) in ABCLEAR 2 and 3 populations, with 70% of patients showing a reversal of negative quality of life trajectory. He stated it's difficult to speculate on conditional trial duration but highlighted the significant unmet need. Anavex is expanding corporate development partnership activities, including presenting at a major conference in San Francisco. He explained that Collagen 24A1 is crucial for the extracellular matrix; its mutation impairs autophagy restoration, leading to a reduced response to Blarcamesine, while wild-type carriers (70% prevalence) show significant benefits, which will be published soon.

Tom Bishop from BI Research inquired about the specific biomarker data requested by the CHMP, particularly regarding brain atrophy and its correlation with cognition. He also asked if the compelling AbClear data could be included in the re-examination, the potential duration of a conditional trial if EMA approval is granted, Anavex's progress in exploring commercialization partnerships, and the mechanism of action for Collagen 24A1.

Answer

President and CEO Christopher Missling explained that objective biomarkers like brain atrophy, which Blarcamesine significantly impacts, will be crucial for the CHMP re-examination, along with correlation analysis to cognitive improvements. He highlighted the strong clinical and functional benefits observed across AbClear 2 and 3 populations, including a reversal of quality of life decline in 70% of patients. Missling noted the difficulty in speculating on conditional trial timelines but emphasized the unmet medical need and the company's focus on expanding corporate development and partnership activities. He detailed that Collagen 24A1, a key extracellular matrix component, influences Blarcamesine's efficacy, with wild-type patients showing significant benefits, a finding to be published soon.

Tom Bishop from BI Research asked for an update on the company's clinical trial pipeline beyond ANAVEX 3-71, a breakdown of the $10M in R&D spending, and the reasons for the delay in initiating a new Parkinson's disease study. He also questioned the status of the Rett syndrome program, the specifics of the EMA decision process, the potential go-to-market strategy in Europe, and the reason for the increase in non-cash compensation expenses.

Answer

President & CEO Dr. Christopher Missling clarified that while ANAVEX 3-71 is the only formal trial, blarcamesine is available via compassionate use in Australia. He attributed R&D costs to blarcamesine manufacturing (CMC), and preparations for future Parkinson's and Fragile X trials. The Parkinson's trial delay is to ensure a robust design that accounts for confounding variables like L-DOPA usage. On commercialization, he stated all options are open, from partnering to a solo launch. Principal Financial Officer Sandra Boenisch explained that higher non-cash compensation is a function of stock price at grant and vesting schedules.

Tom Bishop from BI Research asked about the company's current clinical trial activity, the allocation of its R&D spending, the status of its pipeline programs including Parkinson's, Rett syndrome, and Fragile X, the EMA decision process, potential commercialization plans, and the reason for the increase in non-cash compensation expenses.

Answer

President & CEO Dr. Christopher Missling confirmed ANAVEX 3-71 is the main active trial and that R&D spending is directed towards blarcamesine manufacturing (CMC) and preparations for future Parkinson's and Fragile X studies. He explained the Parkinson's trial design is being carefully considered due to disease complexity. Principal Financial Officer Sandra Boenisch clarified that higher non-cash compensation is a function of stock price at grant and vesting schedules. Dr. Missling added that all commercialization options, including partnering or going solo in Europe, remain open.

Inquired about the specifics of the schizophrenia trial, the company's European pre-launch strategy for blarcamesine, regulatory plans for other countries, the timeline to potential revenue, and manufacturing status.

Answer

The schizophrenia trial's Part B has a 28-day treatment duration. For a European launch, the company is exploring both partnerships and an independent sales force. Regulatory discussions with the UK, Canada, and Australia are planned to run in parallel with the EMA review. Post-approval revenue could start quickly in some EU countries, and the drug is already being manufactured in the US with a large launch inventory ready.

Tom Bishop from BI Research asked for clarification on the schizophrenia trial's duration, pre-launch commercialization plans for blarcamesine in Europe, the distinction between ANAVEX 3-71 and blarcamesine, regulatory plans for other countries, the potential timeline to revenue post-approval, and manufacturing details.

Answer

President and CEO Dr. Christopher Missling clarified that the longer duration for the schizophrenia trial's Part B is 28 days. For European commercialization, he explained Anavex is exploring partnerships and the option of building its own sales force via CROs, with the final decision based on maximizing shareholder value. He confirmed ANAVEX 3-71 is a different molecule from blarcamesine. Dr. Missling noted that the company plans to engage with regulators in the U.K., Canada, and Australia in parallel with the EMA review. Post-approval revenue could begin quickly in some EU countries, and the company has a large launch inventory manufactured in the U.S.

Tom Bishop of H.C. Wainwright & Co. inquired about several key topics, including the expected timeline for a European regulatory decision on blarcamesine, the status of discussions with the FDA, and potential interest from pharmaceutical partners for commercialization. He also asked for updates on the ANAVEX 3-71 trial in schizophrenia, the Rett syndrome program, the Parkinson's disease program, and the significance of a recently issued crystalline patent. Further questions covered upcoming catalysts and the nature of the 'increasing support' mentioned by the company.

Answer

Dr. Christopher Missling, President and CEO, stated that feedback on the European filing for blarcamesine is expected by the end of the year. He confirmed that partnership discussions are ongoing and that the company has sufficient drug supply for a potential launch, with the path forward to be determined by shareholder value. Dr. Missling highlighted the significance of the new patent, which covers the API used in all major trials and extends protection to at least 2039. He provided updates on the pipeline, noting ANAVEX 3-71 schizophrenia data is expected in H1 2025, a new Rett syndrome study is planned, and a Parkinson's program update is forthcoming. He also confirmed plans for a meeting with the FDA.

Tom Bishop of H.C. Wainwright & Co. inquired about several key topics, including the expected timeline for a European regulatory decision on blarcamesine, upcoming catalysts like the ANAVEX 3-71 trial, the status of the Rett syndrome and Parkinson's disease programs, the significance of a new crystalline patent, and the nature of interest from stakeholders and potential pharmaceutical partners.

Answer

Dr. Christopher Missling, President and CEO, stated that feedback from the EMA's 210-day review is expected by the end of the year. He highlighted upcoming catalysts including ANAVEX 3-71 schizophrenia data in H1 2025 and detailed ATTENTION-AD data in April. Dr. Missling confirmed that partnership discussions are ongoing, a new Rett syndrome study is planned, and the new patent is highly significant as it covers the API used in all prior trials, extending protection to at least 2039. He also noted plans for a meeting with the FDA regarding blarcamesine for Alzheimer's.

Tom Bishop of BI Research asked for management's perspective on the recent stock sell-off tied to tech sector news, questioning if the market's negative reaction was unfounded given that Sterling's underlying data center business appears to be accelerating.

Answer

CEO Joseph Cutillo agreed the market reaction was unfounded, stating that regardless of the specific technologies used, data centers must be built, which is Sterling's core business. He relayed that direct conversations with customers confirm they are not backing down and, if anything, are moving faster. He expressed his personal view that recent geopolitical events will ultimately drive more, not less, technology development and construction within the U.S.