VIENNA, Va. - CEL-SCI Corporation (NYSE American: CVM), a biotech firm specializing in cancer immunotherapies, announced today a public offering of 10,845,000 shares priced at $1.00 each, with an expected gross of $10.8 million before fees and expenses. The offering, scheduled to close on July 29, 2024, includes common stock and pre-funded warrants.
The proceeds are earmarked for the development of Multikine, the company's leading investigational therapy, alongside general corporate needs and working capital. ThinkEquity is the sole placement agent for the transaction.
The shares and warrants are being offered under a previously filed SEC shelf registration statement. Prospective investors can access details through a prospectus supplement and accompanying base prospectus available on the SEC website or directly from ThinkEquity.
CEL-SCI's focus is on activating the immune system to combat cancer and infectious diseases. Multikine, which has received Orphan Drug Status from the FDA for head and neck cancer treatment, is set to enter a confirmatory trial in the final quarter of 2024.
The press release includes forward-looking statements regarding the offering's terms, anticipated proceeds, and closing, which are subject to market conditions and other factors that could impact the actual outcome.
This public offering announcement does not constitute an offer to sell or a solicitation of an offer to buy in any state or jurisdiction where such an offer or sale would be illegal before registration or qualification under the securities laws of any such jurisdiction. The information is based on a press release statement.
In other recent news, CEL-SCI Corporation has reported encouraging outcomes from a comprehensive bias analysis for its Phase 3 study of Multikine, a promising immunotherapy for head and neck cancer.
The analysis, involving 923 patients, confirmed no significant differences between the treatment and control groups, supporting the clinical effect of Multikine in extending patient survival. Following these results, the company is preparing to submit this data to regulatory agencies, including the FDA, for a confirmatory registration study.
In addition, the FDA has given the green light to CEL-SCI for a confirmatory Registration Study of Multikine. This approval allows CEL-SCI to proceed with a 212-patient study focusing on newly diagnosed patients with no lymph node involvement and low PD-L1 tumor expression, a group that showed a significant survival benefit in the Phase 3 study.
These are recent developments that highlight the progress CEL-SCI is making in the field of cancer immunotherapy. However, it is important to note that Multikine is still under investigation and has not yet been approved by the FDA or any other regulatory agency. As such, its safety and efficacy have not yet been established for any use.
InvestingPro Insights
CEL-SCI Corporation's recent move to bolster its financial position through a public offering comes at a challenging time for the company. InvestingPro data indicates a concerning financial performance with a gross profit of negative $19.98 million and an operating income, adjusted to negative $29.21 million, both for the last twelve months as of Q2 2024. Moreover, the company's EBITDA, although showing a growth of 13.79% in the same period, stands at negative $27.03 million, underscoring the financial hurdles CEL-SCI faces.
InvestingPro Tips highlight several key issues investors should be aware of. The company's stock has experienced significant volatility, with a 1-week price total return at negative 8.33% and a staggering 6-month price total return at negative 57.99%. This could indicate investor skepticism regarding the company's short-term prospects. The fact that analysts do not anticipate CEL-SCI will be profitable this year, coupled with weak gross profit margins, may raise concerns for potential investors considering the recent public offering.
For investors seeking a more comprehensive analysis, there are additional InvestingPro Tips available, which could provide deeper insights into CEL-SCI's financial health and market performance. To explore these further, visit https://www.investing.com/pro/CVM and remember to use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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