CEL-SCI Announces Closing of $2.5 Million Offering

Rhea-AI Summary

CEL-SCI (NYSE American: CVM) has announced the closing of a $2.5 million best-efforts offering, consisting of 16,000,000 shares of common stock or pre-funded warrants. The offering's gross proceeds, before deducting placement agent fees and expenses, reached approximately $2,560,000.

The company plans to use the net proceeds to fund the continued development of Multikine, their cancer immunotherapy treatment, along with general corporate purposes and working capital. ThinkEquity served as the sole placement agent for this offering, which was conducted under CEL-SCI's effective shelf registration statement.

Multikine, which has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck cancer patients, is currently proceeding with a confirmatory Registration Study. This study will enroll 212 newly diagnosed patients with specific criteria, targeting a potential annual patient pool of about 100,000.

Positive

• FDA approved target patient selection criteria for Registration Study
• Large potential market with 100,000 annual eligible patients
• Multikine has FDA Orphan Drug designation

Negative

• Dilutive $2.5M offering impacts existing shareholders
• Company requires additional funding for operations
• Multikine still not FDA approved or licensed for sale

Insights

Financial Analyst

CEL-SCI's $2.5 million financing comes at a significant cost to existing shareholders. With 16 million new shares being issued at an implied price of approximately $0.16 per share—representing a 44% discount to the current $0.2841 share price—this financing is substantially dilutive for a company with only a $24.5 million market cap.

The $2.5 million raised appears insufficient for the planned 212-patient registration study for Multikine, their head and neck cancer immunotherapy. Clinical trials of this size typically require significantly more capital, suggesting this financing provides only runway extension and that additional dilutive financings may be necessary.

Several concerning elements stand out: the "best-efforts" structure rather than a firm commitment underwriting; the steep discount to market price; and the timing relative to their developmental stage. These factors typically signal weak institutional demand and challenging capital-raising conditions.

While the capital infusion allows continued operations in the near term, the structure and pricing suggest financial pressure that could further impact shareholder value. For a micro-cap biotech with ongoing clinical development costs, securing adequate financing without excessive dilution remains a critical challenge that this offering doesn't resolve.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the closing of its previously announced best-efforts offering of 16,000,000 shares of its common stock (or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof). Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, is approximately $2,560,000. All the shares and Pre-Funded Warrants in the offering were offered by the Company

The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital.

ThinkEquity acted as sole placement agent for the offering.

The securities were offered and sold pursuant to the Company’s currently effective shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 1, 2022, and declared effective on July 15, 2022. The offering was made by means of a prospectus supplement and accompanying prospectus describing the terms of the offering which have been filed with the SEC and available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41^st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful 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 before surgery, radiotherapy and chemotherapy have damaged it should provide the greatest possible impact 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 thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, 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, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.

The Company has operations 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," "anticipated," "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 projected. Such statements include, but are not limited to, statements about the use of proceeds. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250318221229/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

 

Source: CEL-SCI Corporation

FAQ

How much did CEL-SCI (CVM) raise in their latest offering?

CEL-SCI raised approximately $2.56 million in gross proceeds through an offering of 16 million shares of common stock or pre-funded warrants.

What will CEL-SCI use the $2.5 million offering proceeds for?

The proceeds will fund Multikine development, general corporate purposes, and working capital.

How many patients will be enrolled in CEL-SCI's Multikine Registration Study?

The Registration Study will enroll 212 newly diagnosed head and neck cancer patients with specific criteria.

What is the target patient population for CEL-SCI's Multikine treatment?

Multikine targets patients with locally advanced primary treatment naïve resectable head and neck cancer, with no lymph node involvement and low PD-L1 tumor expression.