INmune Bio(US:INMB)2025-05-08 21:32Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for Q1 2025 was approximately $9.7 million, compared to approximately $11 million for the same period in 2024, indicating an improvement [26] - Research and development expenses totaled approximately $7.6 million for Q1 2025, down from approximately $8.7 million in Q1 2024 [26] - General and administrative expenses remained stable at approximately $2.3 million for both Q1 2025 and Q1 2024 [26] - As of March 31, 2025, the company had cash and cash equivalents of approximately $19.3 million, which is expected to fund operations through Q3 2025 [27] Business Line Data and Key Metrics Changes - The company is preparing to report top-line results from the MINDFUL phase two trial in early Alzheimer's disease, expected in mid to late June 2025 [6][16] - The market opportunity for EXPAREL in early Alzheimer's disease has increased to nearly 70% of early AD patients, up from the previously estimated 40% [7][8] - The safety profile of EXPAREL remains excellent, with no adverse events reported in the ongoing trial [9] Market Data and Key Metrics Changes - The approval of mecanumab in the EU and UK excludes patients with two copies of the APOE4 gene, creating an unmet need for EXPAREL therapy in this subgroup [10][11] - The evolving biomarker landscape in Alzheimer's disease, particularly the significance of p tau 217 levels, is expected to enhance the therapeutic response measurement in patients [12] Company Strategy and Development Direction - The company aims to position itself as a leader in targeting immune dysfunction that drives neuroinflammation in Alzheimer's disease [83][84] - The upcoming BLA filing for Cordstrom in 2026 is part of the company's strategy to address rare diseases, specifically recessive dystrophic epidermolysis bullosa (RDEB) [17][24] - The company is transitioning its manufacturing processes to optimize production for both Inkmune and Cordstrom, ensuring cost-effective scalability [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming MINDFUL trial results, which are anticipated to significantly impact the treatment landscape for early Alzheimer's disease [16][84] - The company is closely monitoring FDA developments and believes that the regulatory environment remains favorable for drug development [36] Other Important Information - The company raised approximately $2.1 million from the sale of common stock after the end of the quarter [27] - The company is also planning to initiate a phase two trial of EXPAREL in patients with treatment-resistant depression once NIH funding is secured [28] Q&A Session Summary Question: Can you walk us through the next steps for the program assuming a positive readout in June? - Management indicated that they would defer specific timelines until after the results and discussions with the FDA [32] Question: Can you comment on the turnover at the FDA and the review team for your program? - Management believes that the FDA remains on track and that the review team is stable [36] Question: How do you think investors will react if EMAC hits but CDR is equivocal? - Management emphasized that EMAC is the primary driver for cognitive changes and that they expect correlations with CDR [46][50] Question: What is the expected reduction in CDR for a trial of this size? - Management expressed confidence in their power calculations based on previous trials and the quality of their patient population [62][70] Question: Are you still on track to initiate the twelve-month open-label trial for Cordstrom? - Management confirmed that they are following FDA guidance and expect to submit an IND later this year [74]