CEL-SCI Corporation Reports $13.6 Million Net Loss, Prepares for Multikine Registration Study

CEL-SCI Corporation has reported its financial results for the six months ending March 31, 2025, revealing a net loss of approximately $13.6 million, a slight improvement from the $13.9 million loss recorded in the same period the previous year. The company's total operating expenses decreased to $13.3 million from $13.6 million, primarily due to a reduction in research and development costs, which fell to $8.4 million from $9.0 million. The decrease in R&D expenses was attributed to lower employee stock compensation expenses, offset by increased costs related to clinical studies and supplies.

In terms of revenue, CEL-SCI did not report any sales, consistent with its ongoing status as a clinical-stage biotechnology company focused on developing its lead investigational therapy, Multikine, for the treatment of head and neck cancer. The company continues to rely on financing activities to support its operations, raising approximately $7.6 million from the issuance of common stock and pre-funded warrants in March 2025. This follows a previous capital raise of $4.4 million in December 2024. As of March 31, 2025, the company had cash and cash equivalents of $1.9 million, down from $5.3 million at the same time last year.

Operationally, CEL-SCI has made significant strides in its clinical development efforts. The company is preparing for a confirmatory registration study of Multikine, which has shown promising results in extending survival rates for patients with advanced primary head and neck cancer. The FDA has indicated that CEL-SCI may proceed with this study, which will focus on a target population of approximately 100,000 patients worldwide. The company believes that Multikine's unique mechanism of action, administered before standard treatments, could address a significant unmet medical need in this patient group.

The company’s employee headcount has increased, with a weighted average of 84.5 million common shares outstanding as of March 31, 2025, compared to 52 million shares a year earlier. This increase reflects the company's ongoing efforts to attract talent and support its clinical and operational initiatives. CEL-SCI's management has expressed confidence in its ability to raise additional capital to fund its operations, although it acknowledges the uncertainty surrounding market conditions and the need for regulatory approvals.

Looking ahead, CEL-SCI plans to continue its focus on the development of Multikine and its other product candidates, while actively seeking partnerships and financing to support its clinical trials. The company has indicated that it may need to raise approximately $30 million to fund the upcoming confirmatory study. Despite the challenges, CEL-SCI remains optimistic about its prospects, particularly given the encouraging data from its Phase III trials and the potential for regulatory approval in the near future.