VIENNA, Va.–( BUSINESS WIRE )–CEL-SCI Corporation (CEL-SCI or the Company) (NYSE American: CVM), a clinical-stage cancer immunotherapy company, today announced that it intends to offer its shares of common stock for sale (and/or pre-funded warrants instead) in a public offering in the best way. The offer is subject to market conditions and there can be no assurance as to whether or when the offer will be completed, or the actual size or terms of the offer.
The Company intends to use the net proceeds of this offering to fund the continued development of Multikine, for general corporate purposes and working capital.
ThinkEquity is acting as the sole placement agent for the offering.
The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (SEC) on July 1, 2022 and declared in force on 15 July 2022. The offer will be made only through a written prospectus. A preliminary prospectus supplement and accompanying base prospectus describing the terms of the offering have been or will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street (NYSE:), 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and accompanying base prospectus and other documents filed by the Company with the SEC incorporated by reference in such preliminary prospectus supplement and accompanying prospectus, which provide more information about the Company and such offering.
This press release will not constitute an offer to sell or the solicitation of an offer to buy nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be illegal prior to registration or qualification under the securities laws of any such state or jurisdiction.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible effect on survival. Multikine is designed to help the immune system “target” the tumor at a time when the immune system is still relatively intact and therefore thought to be more capable of attacking the tumor.
Multikine (leukocyte interleukin, injection), a true first-line cancer therapy, has been dosed in more than 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 data from a completed Phase 3 randomized controlled trial, the FDA agreed with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory registration study that will enroll 212 patients. CEL-SCI will include newly diagnosed locally advanced primary treated patients with resectable head and neck cancer without lymph node involvement (as determined by PET scan) and with low tumor PD-L1 expression (as determined by biopsy), representing approximately 100,000 patients per year.
The company operates in Vienna, Virginia, and near/in Baltimore, Maryland.
Forward-looking statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words “intends”, “believes”, “expects”, “plans” and “expects” and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated. Such statements include, but are not limited to, statements about the proposed offer. Factors that could cause or contribute to such differences include the inability to replicate clinical results demonstrated in clinical studies, the timely development of any potential product that can be demonstrated to be safe and effective, obtaining necessary regulatory approvals, difficulties in manufacturing any of the Company’s products. potential products, the inability to raise the necessary capital and risk factors set forth from time to time in CEL-SCI’s filings with the Securities and Exchange Commission, including but not limited to the Annual Report on Form 10-K for the year ended March 30, September 2023. The Company undertakes no obligation to make public the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after this date or to reflect the occurrence of unforeseen events, unless required to do so applicable securities law.
Multikine (leukocyte interleukin, injection) is a trademark registered by CEL-SCI for this investigational therapy. This trademark is subject to review by the FDA in connection with the Company’s future anticipated regulatory submission for approval. Multikine is not licensed or approved for sale, exchange or substitution by the FDA or any other regulatory agency. Similarly, its safety or effectiveness has not been established for any use.
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Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Source: CEL-SCI Corporation
