New Risk • May 04
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (189% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (US$18.5m market cap). Announcement • Apr 18
CEL-SCI Corporation has filed a Follow-on Equity Offering in the amount of $15 million. CEL-SCI Corporation has filed a Follow-on Equity Offering in the amount of $15 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,440,367
Price\Range: $4.36
Discount Per Security: $0.3052
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 3,440,367 Announcement • Dec 31
CEL-SCI Corporation Provides Clinical and Corporate Developments CEL-SCI Corporation announced that it is in final preparations to start enrollment of its 212-patient U.S. 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. Enrollment is expected to begin in Spring 2026. CEL-SCI plans to seek early approval based on early tumor response data which is expected by 2028. An application was submitted for Breakthrough Medicine Designation for Multikine in the treatment of head and neck cancer in Saudi Arabia as recommended by the Saudi Food and Drug Authority (SFDA). This was done in combination with a Saudi company, also as recommended by the SFDA. In response to an additional request, CEL-SCI also submitted a blueprint for its strategy to support and become a part of the Saudi Arabia's ambitious Vision 2030 goals to further advance the Kingdom's global leadership in biotechnology. CEL-SCI's cGMP dedicated manufacturing facility commissioning was validated and manufacturing of Multikine for the confirmatory Registration Study was completed, a significant milestone towards starting enrollment. Should Multikine receive regulatory clearance for patient access and sales in Saudi Arabia based on the Breakthrough Medicine Designation, CEL-SCI is ready to manufacture and ship doses to Saudi Arabia from its U.S. facility while diversifying its geographic manufacturing base with support from Saudi counterparts. CEL-SCI is working closely with Ergomed, a clinical research organization (CRO) with a strong track record of fast enrolment and high-quality study delivery, to complete the final preparations for its confirmatory Registration Study. Ergomed has been a strategic partner and collaborator for over 10 years and was instrumental in successfully completing the Phase 3 study. A new study supports CEL-SCI's strategy to seek early approval in the U.S. In June 2025, 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. Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study of 928 patients, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study which will enroll 212 patients. Factors that the data from the prior Phase 3 study will enroll 212 patients in the U.S.