Financial Data and Key Metrics Changes - As of September 30, 2025, the company had $136.1 million in cash and marketable securities, expected to support clinical and operational activities into early 2027 [10] - R&D expenses for Q3 2025 were $22 million, a decrease from the prior year primarily due to reduced CRO costs associated with the ALTITUDE-AD clinical trial [10] - G&A expenses were $4.5 million in Q3 2025, down due to reductions in legal fees, audit, and recruiting expenses [10] - The company reported a loss from operations and a net loss of $26.5 million for the quarter [11] Business Line Data and Key Metrics Changes - The ALTITUDE-AD trial is progressing with 542 participants enrolled, and some are beginning to complete the placebo-controlled phase [4][5] - The open-label extension of the trial allows participants to receive sabirnetug at 35 mg per kg every four weeks for up to 52 weeks, aimed at gathering long-term safety and efficacy data [5] Market Data and Key Metrics Changes - The company is exploring a strategic collaboration with JCR Pharmaceuticals to develop an Alzheimer's disease product that combines A-beta oligomer selective antibody expertise with blood-brain barrier technology [6][8] Company Strategy and Development Direction - The company is focused on advancing the ALTITUDE-AD trial and the Enhanced Brain Delivery (EBD) program, targeting synaptotoxic A-beta oligomers for Alzheimer's treatment [4][11] - The addition of Dr. George Golembeski to the board is expected to enhance strategic initiatives and business development efforts [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of the ALTITUDE-AD trial and anticipates sharing top-line results in late 2026 [11] - The EBD program is seen as a potential next-generation product opportunity in Alzheimer's treatment [5][11] Other Important Information - The company plans to present data at upcoming medical conferences related to the EBD program [7] - A non-clinical data package, including a non-human primate study, is expected in early 2026 to inform decisions on advancing development candidates [8] Q&A Session Summary Question: What are the criteria for the early transferrin data for a go/no-go decision? - Management indicated that they are looking for a meaningful increase in overall exposure of sabirnetug in the brain, which could enhance efficacy and safety [15][16] Question: How does the Evoke trials impact the company's approach? - Management is monitoring the GLP-1 studies closely and believes that improved metabolic profiles could positively affect Alzheimer's patients [18] Question: Will both candidates in the shuttle program be advanced simultaneously? - It is too early to determine if one or both candidates will advance, as it will be data-dependent in early 2026 [36] Question: What biomarkers will be included in the non-clinical data package? - The data package will include preclinical studies on pharmacokinetics and biomarker profiles, including A-beta levels and synaptic markers [32][33] Question: What is the minimum expectation from the ALTITUDE-AD study? - The primary outcome will be assessed using the iADRS scale, and management is looking for a clear and demonstrable effect on clinical scales [40][42]