INmune Bio(US:INMB)2020-05-15 02:07Financial Data and Key Metrics Changes - The net loss attributable to common stockholders for Q1 2020 was $2.1 million, compared to $1.9 million for Q1 2019 [30] - Research and Development expenses totaled approximately $0.8 million for Q1 2020, compared to approximately $0.6 million for Q1 2019 [30] - General and administrative expenses were approximately $1.3 million in both Q1 2020 and Q1 2019 [31] - As of March 31, 2020, the company had cash and cash equivalents of approximately $5.9 million with no debt [31] Business Line Data and Key Metrics Changes - The DN-TNF Platform includes four therapeutic programs: INB03 for cancer, LIVNate for NASH, Quellor for COVID-19 complications, and XPro1595 for Alzheimer's disease [7][8] - The XPro1595 program is expected to have data for review in October 2020 [13] - The INB03 program targets women with metastatic HER2+ breast cancer, with a planned Phase 2 trial informed by recent research [15][16] Market Data and Key Metrics Changes - The NK Priming Platform, INKmune, is being studied in solid tumors and hematologic malignancies, with delays due to the COVID-19 pandemic [24][28] - The company is focusing on enrolling patients in high-risk MDS and ovarian cancer trials, with expectations for patient enrollment in 2021 [28][35] Company Strategy and Development Direction - The company is prioritizing programs that can bring value to investors and make a difference at the bedside [82] - The strategic assessment led to the initiation of the Quellor program targeting cytokine storms related to COVID-19 [8] - The company is exploring non-dilutive funding options to support clinical trials [12][33] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism about meeting clinical trial goals despite challenges posed by the COVID-19 pandemic [28][70] - The FDA has been responsive and supportive in the context of COVID-19, facilitating trial designs [70] - The company is monitoring the evolving situation regarding COVID-19 and its impact on patient populations [57][70] Other Important Information - The company has signed an agreement with KBI Biopharma for drug manufacturing to support expanding clinical programs [23][55] - The company is preparing for a potential pediatric plan related to COVID-19 complications, considering the role of TNF inhibitors [64] Q&A Session Summary Question: Concerns about Lapatinib's commercial viability - Management acknowledged the challenges in restoring Lapatinib sensitivity but emphasized the importance of addressing trastuzumab resistance in treatment strategies [38][39] Question: R&D expense trends - Management indicated ongoing evaluations of costs related to the COVID trial, with potential expenses ranging from $3 million to $5 million [42][43] Question: Drug product availability for COVID study - Management confirmed sufficient drug supply for the COVID trial and outlined a two-step Phase 2 trial design with a total of 360 patients [47][48] Question: Timing of COVID-19 trial - Management noted that the trial's timing depends on FDA approval and the severity of COVID-19 in the U.S. [70][71] Question: Plans for Kawasaki-like disease in pediatrics - Management is closely monitoring developments related to Kawasaki-like disease and sees potential for their drug in this context [63][64] Question: Alzheimer's disease program details - Management provided insights into the Phase I trial design, focusing on biomarkers of inflammation and cognitive outcomes [75][78]