Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for Q3 2025 was approximately $6.5 million, a decrease from approximately $12.1 million in Q3 2024 [24] - Research and development expenses totaled approximately $4.9 million for Q3 2025, down from approximately $10.1 million in the same period of 2024 [24] - General and administrative expenses were approximately $2.5 million for Q3 2025, compared to approximately $2.2 million in Q3 2024 [24] - As of September 30, 2025, the company had cash and cash equivalents of approximately $27.7 million, sufficient to fund operations into Q4 2026 [24] Business Line Data and Key Metrics Changes - The Cordstrom program is preparing for submission for marketing approval in the UK and US, with significant improvements noted in patients suffering from recessive dystrophic epidermolysis bullosa (RDEB) [5][10] - The EXPRO platform is focused on treating neuroinflammation in Alzheimer's disease, with a manuscript detailing Phase 2 Mindful trial results submitted for peer-reviewed publication [8][20] - The Incuboom program completed its Phase 2 trial in prostate cancer ahead of schedule, meeting the primary endpoint and two of three secondary endpoints [9][18] Market Data and Key Metrics Changes - The company is optimistic about the regulatory environment, with plans to file a Marketing Authorization Application (MAA) in the UK and a Biologics License Application (BLA) in the US for Cordstrom [10][26] - There is a significant unmet need in the RDEB market, with current treatments being expensive and not widely available through the NHS [60] Company Strategy and Development Direction - The company aims to advance its three drug platforms in parallel to provide strength and opportunity, with a focus on achieving key development milestones [10] - Cordstrom is viewed as a platform opportunity with potential applications in various diseases beyond RDEB, including cancer [8][10] - The EXPRO platform is positioned to address gaps in Alzheimer's treatment, particularly for patients with strong inflammatory profiles [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the next couple of years, expecting to demonstrate the success of their efforts through key development milestones [5] - The company is focused on regulatory alignment and advancing discussions with potential partners to support late-stage clinical development [20] - Management acknowledged the challenges in Alzheimer's drug development but remains confident in EXPRO's potential as a differentiated therapy [22] Other Important Information - The company has relocated to rented CGMP manufacturing space compliant with commercial production as a licensed medicine [16] - The Phase 2 Mindful trial results indicate that longer treatment durations with EXPRO are associated with greater improvements in neuropsychiatric symptoms [21] Q&A Session Summary Question: What are the biggest questions for the end of Phase 2 meeting with the FDA? - Management indicated that questions will focus on EMAC, enrichment biomarkers, and the safety database required for commercialization [32] Question: How are partnership discussions progressing for EXPRO? - Management noted that discussions are ongoing but are waiting for regulatory feedback and more data before aggressive partnering [36] Question: What is the current treatment paradigm for RDEB in the UK? - Management clarified that there is no RDEB-specific treatment available through the NHS, and Cordstrom is expected to fill this gap with a systemic effect [60] Question: What is the cash runway for upcoming milestones? - The current cash position is expected to support operations through Q4 2026, with significant milestones anticipated in early 2026 [67]

Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for the year ended December 31, 2024, was approximately $42.1 million, compared to approximately $30 million for 2023, indicating a significant increase in losses [41] - Research and development expenses totaled approximately $33.2 million for the year ended December 31, 2024, compared with approximately $20.3 million for 2023, reflecting a substantial increase in investment in R&D [41] - General and administrative expenses were approximately $9.5 million for the year ended December 31, 2024, compared with approximately $9.6 million for 2023, showing a slight decrease [41] - As of December 31, 2024, the company had cash and cash equivalents of approximately $20.9 million, with an additional $5.4 million raised since year-end through the use of the ATM [42] Business Line Data and Key Metrics Changes - The ADO2 trial for Alzheimer's disease enrolled 208 patients across eight countries, with nearly 800 patients screened, indicating a rigorous patient selection process [15][16] - The CARE-PC trial using IncMUNE for treating metastatic prostate cancer has made steady progress, with completion of dosing in the Phase 1 dose escalation part and ongoing dosing in the Phase 2 part [18] Market Data and Key Metrics Changes - The company has pivoted to solid tumors with the INCMUNE platform, believing that future opportunities are greater in this area compared to hematologic diseases [17] Company Strategy and Development Direction - The company aims to challenge the traditional amyloid-centric paradigm of Alzheimer's disease treatment by focusing on neuroinflammation as a primary driver [14][35] - The addition of Cordstrom has introduced a third therapeutic platform, which is expected to accelerate the timeline to becoming a commercial entity [37] - The company plans to file a Biologics License Application (BLA) for Cordstrom in the first quarter of next year, marking a significant milestone towards revenue generation [45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming results from the ADO2 trial, viewing it as a potential catalyst for a paradigm shift in Alzheimer's treatment [35][36] - The company is focused on achieving primary clinical objectives while remaining cost-prudent, with expectations of sufficient cash to fund operations through Q3 2025 [42][43] Other Important Information - The company has received orphan drug status and rare pediatric disease designation for Cordstrom, differentiating it from other therapies by providing a systemic disease-modifying approach [22] Q&A Session Summary Question: Is the 12-month open-label trial required for filing? - Management indicated that they have access to all clinical data from the current trial and believe it will be adequate for a BLA submission [51] Question: Will the EMAC and CDR results be staggered? - Both EMAC and CDR results will be released simultaneously when the data becomes public [56][57] Question: Are there any dropouts in the Phase II trial? - Dropouts are less than expected, primarily due to typical elderly-related issues rather than drug efficacy or safety concerns [76] Question: How does the company plan to commercialize Cordstrom? - The company aims to move forward independently but may seek a partner for distribution and marketing as they approach commercialization [82][83] Question: Will the BLA for Cordstrom be filed in the UK and US? - The company expects to have all necessary data ready for filing in the first quarter of 2025, with ongoing preparations for both markets [90][91]