INmune Bio(US:INMB)2024-08-01 20:05Financial Performance - The company reported a net loss of $20.8 million for the six months ended June 30, 2024, with cash and cash equivalents of $31.1 million as of that date [89]. - The net loss for the three months ended June 30, 2024, was $9.7 million, compared to a net loss of $6.5 million in the same period of 2023, representing an increase of $3.2 million [101]. - The company reported a recurring net loss of $20.8 million for the six months ended June 30, 2024, compared to a loss of $13.0 million for the same period in 2023, indicating a significant increase in losses [120][121]. - Cash and cash equivalents at the end of the period were $31.1 million, down from $47.8 million at the end of June 2023, reflecting a decrease of approximately 35% [119]. - Operating activities used approximately $15.4 million in cash during the six months ended June 30, 2024, primarily driven by the net loss, which was partially offset by non-cash stock-based compensation of $4.1 million [120]. - The net cash used in operating activities for the six months ended June 30, 2024, was $15.4 million, compared to $4.3 million for the same period in 2023 [112]. - The company anticipates that its current cash and cash equivalents will be insufficient to sustain operations for the next year, raising substantial doubt about its ability to continue as a going concern [116]. Research and Development - The DN-TNF platform is in a Phase 2 trial for Alzheimer's disease, showing a 84% decrease in neurofilament light chain, a 46% decrease in phospho Tau 217, and a 91% decrease in VILIP-1 after three months of therapy [82]. - The Phase II trial for early Alzheimer's disease includes 201 patients, with a primary endpoint of Early/mild Alzheimer's Cognitive Composite (EMACC) and secondary endpoints including CDR-SB [83]. - The company received a $2.9 million award from the National Institute of Mental Health to treat treatment-resistant depression (TRD) with XPro, expecting to initiate a clinical trial in the second half of 2024 [86]. - INKmune therapy was shown to be safe in a Phase I trial for high-risk MDS/AML, inducing memory-like NK cells in patients' circulation for up to four months [87]. - The Phase I/II trial 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 [88]. - The company plans to apply for an accelerated approval pathway for XPro in 2024, with potential eligibility for Break Through status after the Phase II trial in 2025 [85]. - The company anticipates that its research and development expenses will increase significantly for the foreseeable future due to the advancement of multiple product candidates [97]. - Research and development expenses for the three months ended June 30, 2024, were approximately $7.1 million, an increase of $2.9 million compared to $4.1 million in the same period of 2023 [103]. - For the six months ended June 30, 2024, research and development expenses were approximately $15.7 million, compared to $8.3 million in 2023, an increase of $7.5 million [108]. Operating Expenses - The total operating expenses for the three months ended June 30, 2024, were $9.9 million, up from $6.5 million in 2023, reflecting an increase of $3.4 million [101]. - The company expects to continue incurring significant expenses and increasing operating losses as it advances its product candidates through clinical development [98]. Financing and Capital Management - 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 during the six months ending June 30, 2024 [112]. - The company raised approximately $15.5 million through the sale of common stock during the six months ended June 30, 2024, which included net proceeds of approximately $2.0 million from its ATM program [122]. - The company plans to finance operations through various means, including public or private equity sales, debt financing, and potential government funding, but there are no assurances that additional capital will be available on favorable terms [117][118]. - The company is exploring strategic alliances and licensing arrangements as part of its financing strategies to support product development [118]. - The company repaid $5.0 million of its debt during the six months ended June 30, 2024, indicating a focus on managing liabilities [122]. Company Status and Compliance - The company has incurred losses in each period since inception, raising substantial doubt about its ability to continue as a going concern [90]. - The company qualifies as an "emerging growth company" under the JOBS Act, allowing for reduced disclosure requirements [91]. - The company has not reported any material changes in its critical accounting policies and estimates during the six months ended June 30, 2024 [123].