INmune Bio, Inc. reported a net loss of $42.1 million for the fiscal year ending December 31, 2024, an increase from a loss of $30.0 million in the previous year. The company's revenue decreased significantly, generating only $14,000 compared to $155,000 in 2023, primarily from the sale of mesenchymal stem cells (MSCs) to a single customer in the United Kingdom. General and administrative expenses slightly decreased to $9.5 million, while research and development expenses rose sharply to $33.2 million, reflecting increased costs associated with clinical trials for its Alzheimer’s disease treatment, XPro1595, and other product candidates.

The company has made notable progress in its clinical development programs. XPro1595 has completed Phase I trials and is currently in a Phase II trial for early Alzheimer’s disease, with enrollment completed in late 2024. The INKmune program is in an open-label Phase II trial for metastatic castrate-resistant prostate cancer, while CORDStrom, a pooled human umbilical cord mesenchymal stem cell product, has completed a pivotal trial for treating recessive dystrophic epidermolysis bullosa (RDEB). The company plans to submit a Biologics License Application (BLA) for CORDStrom in late 2025 or early 2026.

As of December 31, 2024, INmune Bio had cash and cash equivalents of $20.9 million, down from $35.8 million the previous year. The company reported negative cash flows from operating activities of $33.4 million, indicating a need for additional capital to sustain operations. INmune Bio has raised funds through various means, including the sale of common stock, with gross proceeds of approximately $13 million from a registered direct offering in September 2024. However, the company expressed substantial doubt about its ability to continue as a going concern without securing further financing.

The company’s workforce consisted of 22 full-time employees as of the end of 2024, with operations primarily based in the United States, the United Kingdom, and Australia. INmune Bio is focused on leveraging its proprietary technologies to develop therapies targeting diseases associated with innate immune dysfunction, including cancer and neurodegenerative disorders. The outlook remains cautious, as the company anticipates continued operating losses and the need for additional funding to advance its clinical programs and achieve regulatory approvals.

About Inmune Bio, Inc.

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