Leukocyte interleukin (CEL-SCI)

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a clinical stage cancer immunotherapy company, today announced the pricing of a best-efforts offering of 1,500,000 shares of its common stock. Each share of common stock is being sold at an offering price of $3.82 per share, priced at-the-market under NYSE American rules. Total gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, are expected to be approximately $5.7 million. The offering is expected to close on July 14, 2025, 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 the 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 final 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, 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 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. 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 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, 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.

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced it has reached an agreement with one of Saudi Arabia’s premier pharmaceutical and healthcare companies for a partnership that spans regulatory and commercial activities for Multikine* (Leukocyte Interleukin, Injection) in the Kingdom of Saudia Arabia. The formal agreement is expected to be signed with the Saudi pharmaceutical partner which will file a Breakthrough Medicine Designation application for Multikine with the Saudi Food and Drug Authority (SFDA) in the coming weeks. According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of the Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia. Several leading Saudi funds have expressed interest in investing in Multikine, CEL-SCI, and/or a potential joint venture to serve the wider Middle East and North Africa (MENA) market. We are seeing a significant level of interest in Multikine and CEL-SCI amongst Saudi investment and healthcare leaders. What CEL-SCI offers is exactly in line with Saudi Arabia’s Vision 2030 initiative which seeks to make the Kingdom a global biotech hub. While CEL-SCI has the option of filing for Breakthrough Medicine Designation directly, the Company made a strategic decision to collaborate with its local partner for the regulatory filing and subsequent commercial distribution in Saudi Arabia. In a prior meeting with the SFDA, the Saudi regulatory agency provided guidance and encouragement to seek breakthrough approval for Multikine in head and neck cancer. CEL-SCI and its Saudi pharma partner believe that Multikine meets all requirements for Breakthrough Medicine Designation as published by the SFDA and are now developing a comprehensive commercialization plan. This plan leverages the partner’s deep expertise in the local healthcare market to rapidly take Multikine through regulatory approvals and into distribution. “We have been directly, and through our representative, First Berlin of Germany and its local Saudi representatives, engaging with medical, regulatory and financial experts in Saudi Arabia in preparation for the regulatory filing to the SFDA. These meetings and the support of leaders in the pharmaceutical industry, healthcare and other sectors in Saudi Arabia, are critical ingredients to bringing our cancer drug to market in the Kingdom. Several meetings have also occurred with some of the most important Saudi Arabian funds that have expressed interest in investing in CEL-SCI directly or the venture between CEL-SCI and our Saudi pharma partner,” stated CEL-SCI CEO, Geert Kersten. Martin Bailey, Managing Director and Founder of First Berlin, commented, “We are seeing a significant level of interest in Multikine and CEL-SCI amongst Saudi investment and healthcare leaders. What CEL-SCI offers is exactly in line with Saudi Arabia’s Vision 2030 initiative which seeks to make the Kingdom a global biotech hub. Given the SFDA’s short timeline, this is a near term opportunity for local in-country investors to help bring a much-needed cancer treatment to market while also supporting their nation’s health-tech goals.” Multikine is an immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. In the world’s largest head and neck cancer study spanning 20 countries, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone. The 5-year risk of death was halved from 55% to 27%. About the SFDA’s Breakthrough Medicine Program The SFDA Breakthrough Medicine Program aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia’s Vision 2030 initiative. The program is voluntary and based on early dialogue with drug developers to optimize development plans and speed up evaluation. The goal is to ensure that promising medicines are available as soon as it can be concluded that the medicines’ benefits justify their risks. Eligibility include having to fulfill all of the following four criteria in order to gain a Breakthrough Medicine Designation: Target serious debilitating or life-threatening conditions with unmet medical need. The medicinal product is likely to offer major advantage over methods currently used. The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance. The product is not registered at any regulatory authority at the time of submission of the designation request. 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. 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. 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, inability to receive necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, inability to finalize a partnering agreement 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.