NYSE:CVM
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Multikine Selected as Potential New Standard of Care
CEL-SCI Corporation (NYSE:CVM) provided a pleasant surprise earlier this week highlighting an announcement by the British National Institute for Health and Care Excellence (NICE). The Institute has selected Multikineto to be evaluated as the potential new standard of care for squamous cell carcinoma of the head and neck (SCCHN) in the UK. NICE is an executive non-departmental public body in England, attached to the Department of Health and Social Care which publishes guidelines for health technology and practice. It plays a key role in determining what new medicines, treatments and devices are funded by the National Health Services (NHS) in England.
Details of the selection were provided in a press release by CEL-SCI and a briefing developed by the National Institute for Health and Care Research Innovation Observatory.
NICE selected Multikine due to the lack of other effective therapies, high levels of disease recurrence For SCCHN and favorable safety profile for CEL-SCI’s product. The institute noted that five year survival rates are poor for SCCHN and that metastases are common with approved therapies. The associated briefing noted the “statistically significant 5-year survival benefit” with Multikine.
The selection is a feather in the cap for CEL-SCI and may presage a favorable review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). As a reminder, CEL-SCI made an October 5th announcement regarding its interaction with the agency to discuss a pathway for approval of Multikine for the treatment of head and neck cancer. The MHRA is an executive agency of the Department of Health and Social Care in the United Kingdom and responsible for ensuring that medicines and medical devices work and are acceptably safe. In addition to efforts with the MHRA, the company is also pursuing a pathway to approval with the FDA, EMA and Health Canada.
Capital Raise
A $5 million public offering of stock was closed on November 20th at an offering price of $2.00. 2,490,000 shares and no warrants were issued. The funds will be used to continue to develop Multikine and advance the regulatory submissions to multiple agencies as we have outlined in previous reports. ThinkEquity served as the sole book-runner for the offering.
CEL-SCI Milestones
➢ Presentation of poster at ECHNO – March 2023
➢ Pre-submission meeting with Health Canada – April 2023
➢ Presentation of poster at ESTRO – May 2023
➢ Presentation at AHNS – June 2022
➢ Public offering of common stock – July 2023
➢ Presentation at ESMO – October 2023
➢ Development of clinical study report – 2023
➢ Development of paper(s) for publication in peer reviewed journal – 2023
➢ NICE selection of Multikine for potential standard of care in SCCHN
➢ Feedback from various regulatory agencies – 2024
➢ Submission of license application to various agencies – 2024+
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