CEL-SCI Announces Pricing of $10.8 Million Offering

Rhea-AI Summary

CEL-SCI (NYSE American: CVM), a cancer immunotherapy company, has announced the pricing of a $10.8 million offering of 10,845,000 shares of common stock (or pre-funded warrants) at $1.00 per share. The offering, expected to close on July 29, 2024, aims to fund the development of Multikine, their lead investigational therapy, and general corporate purposes. ThinkEquity is acting as the sole placement agent for this best-efforts offering. CEL-SCI's Multikine has completed a pivotal Phase 3 clinical trial for head and neck cancer and received Orphan Drug Status from the FDA. The company plans to commence a confirmatory trial for Multikine, with enrollment expected to begin in Q4 2024.

Positive

• Raised $10.8 million through a stock offering
• Multikine completed a pivotal Phase 3 clinical trial for head and neck cancer
• Multikine received Orphan Drug Status from the FDA
• Confirmatory trial for Multikine planned to begin enrollment in Q4 2024

Negative

• Potential dilution of existing shareholders due to new stock offering
• Best-efforts offering structure may not guarantee full subscription

Insights

Financial Analyst

CEL-SCI's $10.8 million offering is a significant move that warrants attention. The company is pricing 10,845,000 shares of common stock (or pre-funded warrants) at $1.00 per share, which is a substantial dilution given the company's current market cap. This capital raise, while providing necessary funds, comes at a cost to existing shareholders.

The intended use of proceeds for Multikine development and general corporate purposes suggests that CEL-SCI is bolstering its financial position to support its lead candidate. However, investors should note that this dilution occurs at a relatively low price point, indicating potential market skepticism or urgency for funds.

The expected closing date of July 29, 2024, gives a clear timeline for the transaction. The involvement of ThinkEquity as the sole placement agent adds credibility to the offering, but also implies fees that will reduce the net proceeds available to CEL-SCI.

Investors should closely monitor how efficiently CEL-SCI utilizes these funds, particularly in advancing Multikine through its upcoming confirmatory trial. The success of this trial could be pivotal for the company's future and the potential return on this investment.

Biotechnology Research Analyst

CEL-SCI's focus on immunotherapy for cancer and infectious diseases positions it in a cutting-edge sector of biotechnology. The completion of Multikine's pivotal Phase 3 trial for head and neck cancer, coupled with its Orphan Drug Status from the FDA, are significant milestones that enhance the potential value proposition of the company.

The planned commencement of a confirmatory trial for Multikine in Q4 2024 is a critical next step. This trial could potentially validate the efficacy of Multikine and move it closer to market approval. The $10.8 million raised will be important in funding this trial, which is typically one of the most expensive stages of drug development.

However, investors should be aware that confirmatory trials can be risky. While the previous Phase 3 results were promising enough to warrant this next step, there's no guarantee of success. The outcome of this trial will likely have a substantial impact on CEL-SCI's future and stock performance.

It's also worth noting that while CEL-SCI is focusing on Multikine, having a diversified pipeline is often beneficial in biotech. Investors should keep an eye on any developments in CEL-SCI's other research areas, particularly in infectious diseases, which could provide additional value drivers for the company.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a cancer immunotherapy company, today announced the pricing of a best-efforts offering of 10,845,000 shares of its common stock (or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof). Each share of common stock (or Pre-Funded Warrant) is being sold at an offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). All of the shares and Pre-Funded Warrants in the offering are being offered by the Company. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be $10,845,000. The offering is expected to close on July 29, 2024, subject to satisfaction of customary closing conditions.

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 is acting as 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 (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. A prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, 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 is a clinical-stage biotechnology company focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company’s lead investigational therapy Multikine completed a pivotal Phase 3 clinical trial involving head and neck cancer, for which the Company has received Orphan Drug Status from the FDA. The Company will be commencing a confirmatory trial for Multikine, with enrollment expected to begin in Q4 2024. The Company has operations in Vienna, Virginia, and near Baltimore, Maryland. https://cel-sci.com/

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 terms, expected proceeds, use of proceeds and closing of the offering. 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, 2023. 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/20240726229829/en/

For Investor Relations Inquiries:

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

What is the pricing of CEL-SCI's (CVM) recent stock offering?

CEL-SCI (CVM) priced its recent stock offering at $1.00 per share for 10,845,000 shares of common stock or pre-funded warrants, aiming to raise $10.8 million.

When is CEL-SCI's (CVM) stock offering expected to close?

CEL-SCI's (CVM) stock offering is expected to close on July 29, 2024, subject to satisfaction of customary closing conditions.

What will CEL-SCI (CVM) use the proceeds from the stock offering for?

CEL-SCI (CVM) intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital.

What is the current status of CEL-SCI's (CVM) Multikine therapy?

CEL-SCI's (CVM) Multikine has completed a pivotal Phase 3 clinical trial for head and neck cancer, received Orphan Drug Status from the FDA, and is planning a confirmatory trial with enrollment expected to begin in Q4 2024.