CEL-SCI Announces Pricing of $2.5 Million Offering
CEL-SCI (NYSE American: CVM) has announced a best-efforts offering of 16,000,000 shares of common stock or pre-funded warrants, expected to raise approximately $2.56 million in gross proceeds. The offering is set to close on March 18, 2025, with ThinkEquity acting as sole placement agent.
The company plans to use the net proceeds to fund the continued development of Multikine, their cancer immunotherapy treatment, along with general corporate purposes and working capital. The securities will be offered through a shelf registration statement on Form S-3.
Multikine, which has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck cancer patients, has been administered to over 740 patients. The FDA has approved a confirmatory Registration Study that will enroll 212 newly diagnosed head and neck cancer patients with specific criteria, targeting a potential annual patient pool of about 100,000.
CEL-SCI (NYSE American: CVM) ha annunciato un'offerta a migliori sforzi di 16.000.000 azioni di azioni ordinarie o di warrant pre-finanziati, che ci si aspetta raccolga circa 2,56 milioni di dollari in proventi lordi. L'offerta si chiuderà il 18 marzo 2025, con ThinkEquity che agirà come unico agente di collocamento.
L'azienda prevede di utilizzare i proventi netti per finanziare lo sviluppo continuato di Multikine, il loro trattamento immunoterapico contro il cancro, insieme a scopi aziendali generali e capitale circolante. I titoli saranno offerti tramite una dichiarazione di registrazione di shelf sul modulo S-3.
Multikine, che ha ricevuto la designazione di Farmaco Orfano dalla FDA per la terapia neoadiuvante nei pazienti con cancro testa-collo, è stato somministrato a oltre 740 pazienti. La FDA ha approvato uno studio di registrazione confermativo che arruolerà 212 pazienti con cancro testa-collo recentemente diagnosticati con criteri specifici, mirando a un potenziale pool annuale di pazienti di circa 100.000.
CEL-SCI (NYSE American: CVM) ha anunciado una oferta de mejores esfuerzos de 16.000.000 de acciones de acciones ordinarias o warrants prefinanciados, que se espera recaude aproximadamente 2,56 millones de dólares en ingresos brutos. La oferta se cerrará el 18 de marzo de 2025, con ThinkEquity actuando como único agente de colocación.
La empresa planea utilizar los ingresos netos para financiar el desarrollo continuo de Multikine, su tratamiento de inmunoterapia contra el cáncer, junto con propósitos corporativos generales y capital de trabajo. Los valores se ofrecerán a través de una declaración de registro en estantería en el formulario S-3.
Multikine, que ha recibido la designación de Medicamento Huérfano por parte de la FDA para terapia neoadyuvante en pacientes con cáncer de cabeza y cuello, se ha administrado a más de 740 pacientes. La FDA ha aprobado un estudio de registro confirmatorio que inscribirá a 212 pacientes con cáncer de cabeza y cuello recién diagnosticados con criterios específicos, apuntando a un potencial grupo anual de pacientes de alrededor de 100.000.
CEL-SCI (NYSE American: CVM)는 16,000,000주(주식 또는 선매도권)의 최선의 노력을 기울이는 공모를 발표했으며, 이는 약 256만 달러의 총 수익을 올릴 것으로 예상됩니다. 이 공모는 2025년 3월 18일에 종료될 예정이며, ThinkEquity가 단독 배치 대행사로 활동합니다.
회사는 순수익을 사용하여 Multikine의 지속적인 개발을 자금 지원하고, 일반 기업 목적 및 운영 자본에 사용할 계획입니다. 증권은 S-3 양식에 따른 선반 등록 성명을 통해 제공됩니다.
Multikine은 FDA로부터 두경부암 환자에 대한 신보조요법으로 고아약 지정 승인을 받았으며, 740명 이상의 환자에게 투여되었습니다. FDA는 특정 기준을 충족하는 212명의 새로 진단된 두경부암 환자를 모집할 확인 연구를 승인했으며, 연간 약 100,000명의 잠재적 환자 풀을 목표로 하고 있습니다.
CEL-SCI (NYSE American: CVM) a annoncé une offre à meilleur effort de 16 000 000 d'actions ordinaires ou de bons de souscription préfinancés, qui devrait rapporter environ 2,56 millions de dollars de produits bruts. L'offre doit se clôturer le 18 mars 2025, avec ThinkEquity agissant en tant qu'agent de placement unique.
L'entreprise prévoit d'utiliser le produit net pour financer le développement continu de Multikine, leur traitement d'immunothérapie contre le cancer, ainsi que pour des fins d'entreprise générales et du fonds de roulement. Les titres seront offerts par le biais d'une déclaration d'enregistrement de type shelf sur le formulaire S-3.
Multikine, qui a reçu la désignation de médicament orphelin par la FDA pour la thérapie néoadjuvante chez les patients atteints de cancer de la tête et du cou, a été administré à plus de 740 patients. La FDA a approuvé une étude d'enregistrement confirmatoire qui recrutera 212 patients récemment diagnostiqués avec un cancer de la tête et du cou selon des critères spécifiques, visant un potentiel groupe annuel de patients d'environ 100 000.
CEL-SCI (NYSE American: CVM) hat ein Angebot von 16.000.000 Aktien von Stammaktien oder vorfinanzierten Warrants angekündigt, das voraussichtlich etwa 2,56 Millionen Dollar an Bruttoeinnahmen einbringen wird. Das Angebot wird am 18. März 2025 geschlossen, wobei ThinkEquity als alleiniger Platzierungsagent fungiert.
Das Unternehmen plant, die Nettomittel zur Finanzierung der fortgesetzten Entwicklung von Multikine, ihrer Krebsimmuntherapie, sowie für allgemeine Unternehmenszwecke und Betriebskapital zu verwenden. Die Wertpapiere werden über eine Shelf-Registrierungserklärung auf dem Formular S-3 angeboten.
Multikine, das von der FDA die Orphan-Drug-Bezeichnung für neoadjuvante Therapie bei Patienten mit Kopf-Hals-Krebs erhalten hat, wurde bereits mehr als 740 Patienten verabreicht. Die FDA hat eine bestätigende Zulassungsstudie genehmigt, die 212 neu diagnostizierte Patienten mit Kopf-Hals-Krebs mit spezifischen Kriterien einschreiben wird, mit dem Ziel einer potenziellen jährlichen Patientenzahl von etwa 100.000.
- FDA approval received for confirmatory Registration Study
- Orphan Drug designation from FDA for Multikine
- Large potential patient pool of 100,000 annually for target criteria
- Dilutive $2.56M stock offering affecting current shareholders
- Additional capital raising may be needed for ongoing operations
- Product still in development phase with no guaranteed approval
Insights
CEL-SCI's announcement of a
This financing comes at a particularly challenging time for the company with its tiny market cap of just
The stated use of proceeds for "continued development of Multikine, general corporate purposes, and working capital" suggests the company is primarily raising funds to sustain operations rather than for strategic growth initiatives. The timing and pricing of this offering strongly indicate CEL-SCI is facing immediate capital needs, which is concerning given its long-running clinical development program for Multikine.
While the funds will provide short-term operational runway, the extremely dilutive nature of this offering and the significant discount required to attract investors reflects poorly on the company's financial strength and market position. This financing appears necessary for survival rather than value creation.
CEL-SCI's financing announcement must be evaluated in the context of its ongoing clinical development of Multikine, their immunotherapy candidate for head and neck cancer. The FDA has already concurred with CEL-SCI's target patient selection criteria for a confirmatory Registration Study involving 212 patients with specific characteristics - notably those with no lymph node involvement and low PD-L1 tumor expression.
This
The company's strategy of administering Multikine before surgery, radiotherapy, and chemotherapy represents an interesting scientific approach aimed at leveraging a relatively intact immune system. However, the need for this highly dilutive financing raises questions about previous clinical results and investor confidence in the program.
While Multikine has received Orphan Drug designation and has been dosed in over 740 patients, the need for this confirmatory study after completing a previous Phase 3 trial suggests complex regulatory interactions. The severely discounted offering indicates market skepticism about the probability of clinical and commercial success, despite the scientific merit of the approach. This financing will help continue the program but at significant cost to existing shareholders.
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
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. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.
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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250317508129/en/
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Source: CEL-SCI Corporation
FAQ
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