CEL-SCI Announces Closing of $10.8 Million Offering

Rhea-AI Summary

CEL-SCI (NYSE American: CVM), a cancer immunotherapy company, has closed a $10.8 million offering of 10,845,000 shares of common stock (or pre-funded warrants) at $1.00 per share. The company plans to use the net proceeds to fund the development of Multikine, its lead investigational therapy, as well as for general corporate purposes and working capital. ThinkEquity acted as the sole placement agent for this best-efforts offering. CEL-SCI is preparing to commence a confirmatory trial for Multikine, with enrollment expected to begin in Q4 2024. The company's focus remains on activating the immune system to fight cancer and infectious diseases.

Positive

• Raised $10.8 million in gross proceeds through stock offering
• Funding secured for continued development of Multikine
• Confirmatory trial for Multikine planned to begin enrollment in Q4 2024

Negative

• Potential dilution of existing shareholders due to new stock issuance

Insights

Financial Analyst

CEL-SCI's $10.8 million offering is a significant move for this clinical-stage biotechnology company. The sale of 10,845,000 shares at $1.00 per share provides a important capital injection, bolstering their financial position. This funding is particularly important given the company's focus on developing Multikine, their lead immunotherapy candidate.

The offering's structure, including the option for pre-funded warrants, demonstrates flexibility in attracting investors. However, the $1.00 price point suggests some dilution for existing shareholders. The use of a shelf registration indicates the company's proactive approach to capital raising, allowing them to act quickly when market conditions are favorable.

Investors should note that while this capital raise strengthens CEL-SCI's balance sheet, it's important to monitor how efficiently the company utilizes these funds in advancing Multikine's development and supporting general operations. The planned Q4 2024 start for the confirmatory trial suggests a significant cash burn rate, making this funding essential for near-term operations.

Overall, this offering provides CEL-SCI with a financial runway to progress their clinical programs, but investors should closely watch for updates on Multikine's development and the company's cash management strategies in the coming quarters.

Biotechnology Research Analyst

CEL-SCI's focus on immunotherapy for cancer and infectious diseases places them in a highly competitive and rapidly evolving sector. The completion of Multikine's pivotal Phase 3 trial for head and neck cancer is a significant milestone, with the Orphan Drug Status from the FDA potentially offering market exclusivity and development incentives.

The planned confirmatory trial for Multikine, set to begin enrollment in Q4 2024, is a critical next step. This timeline suggests confidence in their data, but also indicates a lengthy process ahead before potential commercialization. Investors should be aware that the success of this confirmatory trial is important for CEL-SCI's future prospects.

The company's dual focus on cancer and infectious diseases could provide diversification, but also requires significant resources to advance multiple programs simultaneously. The $10.8 million raised, while substantial for a company of CEL-SCI's size, may only fund operations for a time given the high costs associated with late-stage clinical trials.

As the biotech sector faces increased scrutiny and funding challenges, CEL-SCI's ability to efficiently progress Multikine through regulatory hurdles will be paramount. Investors should closely monitor trial progress, any interim data releases and potential partnerships that could support the company's development efforts.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a cancer immunotherapy company, today announced the closing of its previously announced 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) was sold at an offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price), for gross proceeds of $10,845,000, before deducting placement agent fees and other offering expenses. 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 prospectus which have been filed with the SEC and available on the SEC’s website at www.sec.gov. You should read the applicable prospectus supplement and prospectus for more complete information about the Company and the offering. You may obtain these documents free of charge by visiting the SEC website at www.sec.gov. Alternatively, you may obtain copies by contacting ThinkEquity, 17 State Street, 41st 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 use of proceeds 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/20240729532240/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

 

Source: CEL-SCI Corporation

FAQ

How much did CEL-SCI (CVM) raise in its recent offering?

CEL-SCI (CVM) raised $10.8 million in gross proceeds through its recent offering of common stock and pre-funded warrants.

What is the intended use of the funds raised by CEL-SCI (CVM) in this offering?

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

When is CEL-SCI (CVM) expected to begin enrollment for the confirmatory trial of Multikine?

CEL-SCI (CVM) expects to begin enrollment for the confirmatory trial of Multikine in Q4 2024.

What is the main focus of CEL-SCI 's (CVM) research?

CEL-SCI (CVM) focuses on finding the best way to activate the immune system to fight cancer and infectious diseases.