On August 14, 2025 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the three months ended June 30, 2025, as well as key recent clinical and corporate developments (Press release, Cel-Sci, AUG 14, 2025, View Source [SID1234655326]).
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"Commercial and regulatory momentum for Multikine is accelerating due to three driving factors—our partnership negotiations in Saudi Arabia, the increasing interest in CEL-SCI from investors in the Middle East, and continued recognition in the global scientific and regulatory community that PD-L1 is a valuable predictive marker for head and neck cancer," stated CEL-SCI CEO, Geert Kersten. "We are particularly encouraged about the potential for Multikine to become commercially available in Saudi Arabia in 2025. Should this happen, we believe it could support our regulatory and commercial efforts worldwide."
Corporate and Clinical Developments include:
CEL-SCI’s CEO and a Director of the Company each purchased a combined total of 32,116 shares of restricted common CEL-SCI stock in July 2025.
Gross proceeds of approximately $5.7 million were raised by CEL-SCI in July 2025 through the sale of 1,500,000 shares of common stock at an offering price of $3.82 per share, priced at-the-market under NYSE American rules. In May of 2025, the Company raised gross proceeds of $5 million through the sale of 2,000,000 shares of common stock priced at $2.50 per share.
CEL-SCI is set to sign a commercialization and regulatory partnership agreement with a leading Saudi Arabian pharmaceutical company for Multikine* (Leukocyte Interleukin, Injection) in the treatment of head and neck cancer in the Kingdom of Saudi Arabia. A Breakthrough Medicine Designation application for Multikine was filed by the pharma partner with the Saudi Food and Drug Authority (SFDA). According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of the Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia.
Several leading Saudi funds have expressed interest in investing in CEL-SCI, Multikine and/or a potential joint venture to serve the wider Middle East and North Africa (MENA) market. CEL-SCI’s offering with Multikine is in line with Saudi Arabia’s Vision 2030 initiative which seeks to make the Kingdom a global biotech hub. Given the SFDA’s 60-day timeline to make Multikine potentially available, in-country investors have expressed interest in bringing a much-needed cancer treatment to market while also supporting their nation’s health-tech goals.
A new study supports CEL-SCI’s strategy to seek early approval in the U.S. CEL-SCI is in final preparations before starting enrollment of its 212-patient Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients. The U.S. Food and Drug Administration (FDA) has given CEL-SCI the go-ahead for the study. CEL-SCI plans to seek early approval based on early tumor responses. A third-party study recently published in Cancer Cell titled "Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies" provides support for CEL-SCI’s approach. The concept that tumor responses predict survival has been acknowledged for many cancer types and has led to accelerated approval of many cancer drugs. The third-party study published in Cancer Cell gives further support that this is also true in the neoadjuvant pre-surgical immunotherapy treatment of head and neck cancer.
More data on PD-L1 as a predictive biomarker signals a clear regulatory pathway for Multikine in PLD-L1 negative patients. There is a growing body of data on PD-L1 as a predictive biomarker and diagnostic for cancer. In June, the FDA approved Merck’s KEYTRUDA (pembrolizumab), an anti-PD-L1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. Of note, the FDA granted Merck priority review in February 2025 and approval in June 2025 based on interim results. This sets a positive precedent for Multikine in PD-L1 low and negative patients. Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by only 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating improvement in overall survival.
Financial Results
During the three months ended June 30, 2025, net loss available to common shareholders was $5.7 million compared to $7.5 million in the prior year period. Basic and diluted net loss per common share was $1.36 for the three months ended June 30, 2025, compared to $4.18 for the three months ended June 30, 2024. In demonstration of his deep commitment to the Company and Multikine’s potential to significantly improve patient outcomes, CEO Geert Kersten has been and is currently working without taking a salary.