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CEL-SCI’s operations are based in Vienna, Virginia, and near Baltimore, Maryland. The company’s forward-looking statements in the press release acknowledge the inherent risks and uncertainties in the development of pharmaceutical products and the capital markets. Financial metrics from InvestingPro underscore these challenges, with an EBITDA of -$23.94 million in the last twelve months and analysts projecting continued losses for the current fiscal year. Unlock comprehensive financial analysis and 12 additional ProTips with an InvestingPro subscription. Financial metrics from InvestingPro underscore these challenges, with an EBITDA of -$23.94 million in the last twelve months and analysts projecting continued losses for the current fiscal year. Unlock comprehensive financial analysis and 12 additional ProTips with an InvestingPro subscription.
CEL-SCI’s operations are based in Vienna, Virginia, and near Baltimore, Maryland. The company’s forward-looking statements in the press release acknowledge the inherent risks and uncertainties in the development of pharmaceutical products and the capital markets. Financial metrics from InvestingPro underscore these challenges, with an EBITDA of -$23.94 million in the last twelve months and analysts projecting continued losses for the current fiscal year. Unlock comprehensive financial analysis and 12 additional ProTips with an InvestingPro subscription.
Multikine, an investigational therapy, is designed to stimulate the immune system to target tumors before the onset of surgery, radiotherapy, and chemotherapy. The therapy has been administered to over 740 patients and has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for neoadjuvant therapy in specific head and neck cancer cases. Following results from a Phase 3 study, the FDA has agreed to the company’s patient selection criteria for a confirmatory Registration Study.
The securities are being offered pursuant to a shelf registration statement filed with the SEC on July 1, 2022, and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus, with a preliminary prospectus supplement and accompanying base prospectus filed with the SEC.
CEL-SCI’s operations are based in Vienna, Virginia, and near Baltimore, Maryland. The company’s forward-looking statements in the press release acknowledge the inherent risks and uncertainties in the development of pharmaceutical products and the capital markets.
This article is based on a press release statement, and it is important to note that Multikine has not been approved by the FDA or any other regulatory agency, and its safety and efficacy have not been established for any use. The company’s future regulatory submissions and the potential approval of Multikine are subject to FDA review.
In other recent news, CEL-SCI Corporation has completed its application for Breakthrough Medicine Designation for its cancer immunotherapy drug, Multikine, with the Saudi Food and Drug Authority (SFDA). This designation could expedite patient access to Multikine in Saudi Arabia, where head and neck cancers are a significant concern. The company is also preparing to submit a regulatory filing for Conditional Approval of Multikine, following a positive meeting with the SFDA and promising Phase 3 study data. Additionally, CEL-SCI’s Board of Directors has approved a 1-for-30 stock combination, which will take effect soon, converting every 30 shares of existing common stock into one share. This move is intended to attract more investor interest by addressing the company’s current low stock price. CEL-SCI continues to engage in discussions for potential partnerships to secure non-dilutive funding for its confirmatory Registration Study of Multikine. The FDA has provided feedback on the Statistical Analysis Plan for this study, indicating no further response is needed from CEL-SCI. Multikine has shown significant survival benefits in clinical trials, with a 5-year survival rate of 73% for treated patients compared to 45% for those receiving standard care alone.
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