CEL-SCI Announces Closing of $7.75 Million Public Offering of Common Stock
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Insights
The recent public offering by CEL-SCI Corporation signifies a strategic move to bolster the company's financial position. With the capital raised amounting to $7.75 million, it's clear that the company is aiming to enhance its liquidity to support ongoing projects, particularly the development of Multikine. This immunotherapy treatment has the potential to be a game-changer in the oncology market, which is why the investment in its development is critical.
From a financial perspective, the offering price at $2.00 per share is a pivotal figure. Investors would benefit from understanding how this price compares to the current market valuation and historical prices. A lower offering price can sometimes indicate a need for quick capital at the expense of potential dilution of existing shares. It's also important to note the role of ThinkEquity as the sole book-running manager, which suggests confidence in their ability to manage the offering effectively.
When considering the long-term implications, stakeholders should monitor the company's burn rate and the progress of Multikine's development. Success in clinical trials could lead to significant appreciation in the company's stock value, while any setbacks could have the opposite effect. The use of a shelf registration statement also provides flexibility for the company to offer securities in the future without the need for a new registration, allowing for more agile capital raising strategies.
The capital infusion into CEL-SCI's Multikine development is a critical factor for the biotechnology and pharmaceutical industry watchers. Multikine represents a new class of cancer immunotherapy, aiming to stimulate the immune system to fight cancer. Its Phase 3 status indicates that it is in the late stages of clinical trials, which are pivotal in determining efficacy and safety before potential FDA approval.
For stakeholders, the success of Multikine could mean a breakthrough in treatment options for cancer patients, which in turn could lead to a significant market share in the immunotherapy segment. The financial investment in its development is a testament to the company's commitment to bringing this treatment to market. However, it's imperative to evaluate the clinical data and trial results critically as they will be the primary drivers of the product's success or failure.
The allocation of funds from the offering to general corporate purposes and working capital also suggests a broader strategic plan to stabilize the company's operations while focusing on its core project. The balance between funding research and maintaining operational efficiency is a delicate one that requires careful monitoring.
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 acted as sole book-running manager 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
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
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.
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Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
www.cel-sci.com
Source: CEL-SCI Corporation
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