INmune Bio(US:INMB)2024-05-12 00:58Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for Q1 2024 was approximately $11 million, compared to approximately $6.5 million for the same period last year, indicating increased scale in clinical programs [63] - Research and development expenses totaled approximately $8.7 million for the quarter, up from approximately $4.1 million in the comparable period [39] - Cash and cash equivalents as of March 31, 2024, were approximately $26 million, which does not include recent capital raises, and is expected to fund operations into 2025 [64] Business Line Data and Key Metrics Changes - The company continues to enroll patients globally in the early Phase II trial for Alzheimer's disease (AD02), with expectations to meet target enrollment by mid-2024 [7][20] - The INKmune program is progressing with three centers currently enrolling patients, and a fourth center opening soon, with Phase I expected to complete by September 2024 [33] Market Data and Key Metrics Changes - The company raised $14.5 million in gross proceeds from two equity offerings, issuing approximately 1.5 million shares of common stock [37] - The average price per share in the recent offerings was $8.35 and $9.84 [37] Company Strategy and Development Direction - The company aims to apply for fast-track approval for XPro based on preclinical and Phase I data, with potential for breakthrough status after completing the Phase II clinical trial [15] - Future development will focus on treatment-resistant depression as the next indication beyond Alzheimer's disease [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing Phase II trial and the potential for accelerated approval pathways, emphasizing the importance of neuroinflammation in Alzheimer's disease [28][92] - The company is committed to completing the Phase II trial and achieving positive readouts, which will inform future resource allocation and development strategies [110] Other Important Information - The company has closed enrollment for the Phase II open-label extension, with some patients continuing to receive treatment under compassionate use [76] - Management highlighted the ethical considerations of having patients on placebo for extended periods, advocating for a more efficient trial design [51] Q&A Session All Questions and Answers Question: What is the expected mix of patients in the ongoing Phase II trial for early Alzheimer's? - The trial aims for a mix close to 50-50 between mild cognitive impairment and mild Alzheimer's patients, with a two-to-one ratio of active to placebo [73][74] Question: Will there be plans to share data from the open-label extension study? - The company has not yet determined the best way to analyze the open-label extension data due to the complexity of patient entry conditions [75] Question: What are the expectations regarding the FDA's acceptance of neuroinflammation biomarkers? - The FDA is expected to focus on traditional Alzheimer's biomarkers like amyloid and tau, rather than neuroinflammation [79] Question: Is there a chance for conditional approval post Phase II if results are strong? - There is a possibility for expedited pathways if the results are extraordinary, but management remains cautious about predictions [83] Question: What is the timeline for the treatment-resistant depression trial? - The company aims to open the IND and enroll the first patient in the second half of the year, with updates expected as resources allow [109]