CEL-SCI Announces Pricing of $7.75 Million Public Offering of Common Stock

Rhea-AI Summary

CEL-SCI Corporation (CVM) announces a public offering of 3,875,000 shares of common stock at $2.00 per share, aiming to raise $7.75 million for further development of Multikine and general corporate purposes.

Insights

Financial Analyst

The announcement of CEL-SCI Corporation's public offering of common stock is a significant event that necessitates a thorough financial analysis. The pricing of shares at $2.00 for gross proceeds of $7.75 million indicates a strategic move to raise capital for the company's future endeavors, particularly the development of Multikine*. Considering the offering is expected to close on a future date, the immediate impact on the company's liquidity and cash reserves is a point of interest. Investors will be keen on the underwriting discounts and offering expenses, as these will affect the net proceeds and thereby the actual funding available for the company's stated purposes.

Furthermore, the use of a shelf registration statement suggests a pre-planned financing strategy, which may provide the company with flexibility to tap into the market opportunistically. However, the market's response to this offering will depend on the perceived value of Multikine* and the company's overall pipeline and prospects. The stock price reaction following this news will be a key indicator of investor sentiment. It is also essential to consider the dilutive effect of the offering on existing shareholders and how this might impact the stock's performance in the short to medium term.

Market Research Analyst

In the context of the biotechnology and pharmaceutical industry, capital raising through public offerings is a common strategy to fund research and development projects. The decision by CEL-SCI to allocate funds specifically for the development of Multikine* suggests a commitment to advancing their lead product, which is currently in Phase 3. Market analysts would assess the competitive landscape for cancer immunotherapies, evaluating how Multikine* fits within it and its potential market share based on efficacy, safety and the current stage of development.

Understanding the broader market dynamics, such as the demand for cancer immunotherapies and the funding environment for biotech firms, is crucial. The role of ThinkEquity as the sole book-running manager also warrants attention, as their reputation and execution capabilities can influence the offering's success. Analysts would examine historical offerings managed by ThinkEquity to gauge potential outcomes and investor interest levels. This event may serve as a bellwether for the industry's funding trends and investor confidence in biotech innovation.

Medical Research Analyst

From a medical research perspective, the progress of Multikine* through Phase 3 clinical trials is a critical juncture. The allocation of proceeds towards its development underscores the importance of this stage in bringing a new therapy to market. A medical research analyst would delve into the clinical trial data available, scrutinizing the drug's efficacy, safety profile and trial design. The potential impact on treatment paradigms for cancer, if Multikine* were to be approved, is of particular interest.

Furthermore, the implications of successful development could extend beyond the immediate financials. It could position CEL-SCI as a key player in the immunotherapy space, potentially leading to strategic partnerships or acquisition interest. The analyst would also consider the regulatory landscape, as FDA approval processes are stringent and any setbacks could significantly affect the company's valuation and future prospects. The long-term implications of this funding round, in terms of Multikine*'s path to market and the company's scientific credibility, are as consequential as the immediate financial impact.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of an offering of 3,875,000 shares of its common stock at an offering price of $2.00 per share, for gross proceeds of $7.75 million, before deducting underwriting discounts and offering expenses. All of the shares of common stock are being offered by the Company. The offering is expected to close on February 13, 2024, subject to satisfaction of customary closing conditions.

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

ThinkEquity is acting as sole book-running manager 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 has been or will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement, when available, and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such 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 while it is still intact 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. In a Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine administered first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. The Phase 3 study enrolled 928 patients. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.

After analyzing data from the Phase 3 study, we have better defined the target population, which is advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival data in the final target population, showing that Multikine cut the risk of death in half at five years vs control. We plan to submit the proposed study protocol to the FDA in Q1 2024, with the goal to get FDA buy-in for a confirmatory clinical trial, and also to discuss potential accelerated approval pathways.

Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

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 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/20240209945546/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

What is the ticker symbol of CEL-SCI Corporation?

The ticker symbol of CEL-SCI Corporation is CVM.

How many shares of common stock are being offered in the public offering?

CEL-SCI Corporation is offering 3,875,000 shares of its common stock.

What is the offering price per share in the public offering?

The offering price per share in the public offering is $2.00.

What is the expected gross proceeds from the public offering?

The public offering aims to raise gross proceeds of $7.75 million.

When is the expected closing date of the public offering?

The public offering is expected to close on February 13, 2024, subject to customary closing conditions.