INmune Bio(US:INMB)2021-03-05 03:17Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for the year ended December 31, 2020, was approximately $12.1 million, compared to approximately $7.7 million for the year ended December 31, 2019 [32] - Research and development expenses totaled approximately $5.9 million for the year ended December 31, 2020, compared to approximately $3.3 million for the year ended December 31, 2019, primarily due to increased R&D activities related to clinical programs and manufacturing additional drug supply [32] - General administrative expenses were approximately $6.3 million for the year ended December 31, 2020, compared to $6 million for the year ended December 31, 2019 [33] - As of December 31, 2020, the company had cash and cash equivalents of approximately $22 million with no debt [33] Business Line Data and Key Metrics Changes - The company is developing XPro1595 for Alzheimer's disease and other CNS indications, with interim data showing a 40% reduction in neuroinflammation in a small preliminary data set [9][10] - In a phase 1 trial, 8 out of 9 patients were stable or had improved cognition over a three-month period, indicating potential efficacy of XPro1595 [17] - A phase 2 trial for treatment-resistant depression (TRD) is planned, supported by a $2.9 million NIH grant, leveraging insights from the Alzheimer's program [21][23] Market Data and Key Metrics Changes - The company plans to initiate a phase 2 trial of XPro1595 in treatment-resistant depression, targeting a subset of patients with biomarkers of inflammation [40] - The U.S. has an estimated 7 million patients with major depressive disorder resistant to current therapies, highlighting a significant unmet need in the market [24] Company Strategy and Development Direction - The company aims to start a blinded randomized placebo-controlled phase 2 clinical trial for XPro1595 in Alzheimer's disease in the second half of 2021 [19] - The strategy includes using biomarkers to improve the efficiency of drug development in psychiatric conditions, with a focus on neuroinflammation as a common pathology across various diseases [23][25] - The company is also exploring additional clinical programs in oncology and NASH, pending the resolution of COVID-19 related restrictions [31][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made in the neuroinflammation franchise, particularly following the compelling Alzheimer's disease data reported in January [36] - The company is closely monitoring the role of neuroinflammation in long COVID, indicating potential future research opportunities [59] Other Important Information - The company raised gross proceeds of approximately $28.4 million through its at-the-market facility, issuing 1,439,480 shares of common stock at a price of $20.17 [33] - The company plans to provide more clarity on the design and costs of the phase 2 trial for Alzheimer's disease as it approaches the milestone [35] Q&A Session Summary Question: Will the phase 1b trial see more patients or deeper analyses? - Management confirmed that both more patients and longer follow-up times will be included in the phase 1b trial [38] Question: How does the company view treatment-resistant depression (TRD) patients? - Management indicated that they will focus on TRD patients with biomarkers of inflammation, suggesting a subset of approximately one-third of TRD patients [40] Question: Are there different neuroinflammation biomarkers for TRD compared to Alzheimer's? - Management confirmed the use of a unique connectivity biomarker for TRD patients, alongside standard MRI biomarkers [44] Question: What additional data should be expected from the phase 1b Alzheimer's program? - Management mentioned exploring doses between current cohorts and emphasized the importance of determining the right dose before moving to phase 2 [50] Question: Will the Quellor trial have any impact on long COVID? - Management acknowledged the potential link between neuroinflammation and long COVID, indicating ongoing interest in this area [59] Question: How many patients have passed the 12-week period in the trial? - Management reported that all patients in the high-dose group have enrolled in the extension trial, with some already reaching their one-year anniversary [62]