INmune Bio(US:INMB)2024-05-09 20:05Financial Performance - The company reported a net loss of $11.0 million for the three months ended March 31, 2024[113]. - For the three months ended March 31, 2024, the company reported revenues of $14,000, a decrease of 63.16% from $38,000 in the same period of 2023[127]. - The net loss for the three months ended March 31, 2024, was $11.0 million, compared to a net loss of $6.5 million for the same period in 2023, representing an increase of 68.5%[133]. - Total operating expenses for the three months ended March 31, 2024, were $11.0 million, an increase of 70.8% from $6.5 million in the same period of 2023[126]. - The company used approximately $7.5 million in cash for operating activities during the three months ended March 31, 2024, compared to $1.1 million in the same period of 2023[145]. - Cash and cash equivalents decreased to $26.0 million as of March 31, 2024, down from $51.0 million at the end of the same period in 2023[143]. - As of March 31, 2024, the company had cash and cash equivalents of $26.0 million, down from $35.8 million as of December 31, 2023[113]. - The company has incurred losses in each period since inception, raising substantial doubt about its ability to continue as a going concern[114]. Research and Development - The company plans to initiate a Phase II trial for Alzheimer's disease (AD) with 201 patients enrolled in a 2:1 ratio (XPro vs placebo)[108]. - In the Phase I trial for AD, XPro demonstrated a decrease in inflammatory cytokines in the cerebrospinal fluid (CSF) by 84% for neurofilament light chain, 46% for phospho Tau 217, and 91% for VILIP-1 after three months of therapy[107]. - The company received a $2.9 million award from the National Institute of Mental Health (NIMH) to treat treatment-resistant depression (TRD) with XPro[110]. - The Phase I/II trial using INKmune for metastatic castrate-resistant prostate cancer (mCPRC) is expected to be fully enrolled by the first half of 2025, with top-line data available six months later[112]. - The company anticipates significant increases in research and development expenses as it advances more product candidates through clinical development[123]. - Research and development expenses increased to approximately $8.7 million for the three months ended March 31, 2024, compared to $4.1 million for the same period in 2023, reflecting a 111.4% increase[129]. Financing Activities - The company sold 198,364 shares of common stock at an average price of $10.56 for gross proceeds of approximately $2.1 million under the ATM offering from April 4, 2024, to May 6, 2024[134]. - The company raised approximately $4.8 million from the sale of 571,592 shares of common stock and warrants on April 19, 2024[135]. - The company raised approximately $9.7 million from the sale of 986,000 shares of common stock and warrants on April 24, 2024[136]. - The Company repaid $2.5 million of its debt during the three months ended March 31, 2024[147]. Regulatory and Compliance - The company qualifies as an "emerging growth company" under the JOBS Act, allowing for reduced disclosure requirements[115]. - The Company is classified as a "smaller reporting company" and is not required to provide certain market risk disclosures[150]. - There have been no material changes in critical accounting policies and estimates during the three months ended March 31, 2024[148]. Future Plans - The company plans to apply for an accelerated pathway for XPro in 2024, potentially qualifying for Fast Track status[109]. - The company has completed an open-label dose escalation trial for INB03 in cancer patients with metastatic solid tumors, demonstrating safety and pharmacodynamic endpoints[106].