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CEL-SCI (NYSE American: CVM) announced a best-efforts public offering of 16,130,000 shares of common stock (or pre-funded warrants) at $0.31 per share, expecting to raise approximately $5 million in gross proceeds. The offering is set to close on December 31, 2024, with ThinkEquity acting as sole placement agent.
The company plans to use the net proceeds to fund the continued development of Multikine, their first-line cancer therapy which has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck cancer patients. The FDA has approved CEL-SCI’s plans for a confirmatory Registration Study of 212 patients with newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer.
CEL-SCI (NYSE American: CVM) ha annunciato un’offerta pubblica a esforço migliori di 16.130.000 azioni ordinarie (o warrant pre-finanziati) a $0,31 per azione, prevedendo di raccogliere circa $5 milioni di proventi lordi. L’offerta dovrebbe chiudersi il 31 dicembre 2024, con ThinkEquity che funge da unico agente di collocamento.
La società prevede di utilizzare i proventi netti per finanziare lo sviluppo continuato di Multikine, la loro terapia contro il cancro di prima linea che ha ricevuto la designazione Orphan Drug dalla FDA per la terapia neoadiuvante nei pazienti con cancro della testa e del collo. La FDA ha approvato i piani di CEL-SCI per uno studio di registrazione di conferma su 212 pazienti con cancro della testa e del collo localmente avanzato, eseguibile privo di trattamento primario.
CEL-SCI (NYSE American: CVM) anunció una oferta pública de mejor esfuerzo de 16,130,000 acciones de acciones ordinarias (o warrants prefinanciados) a $0.31 por acción, esperando recaudar aproximadamente $5 millones en ingresos brutos. La oferta está programada para cerrar el 31 de diciembre de 2024, con ThinkEquity actuando como único agente de colocación.
La empresa planea utilizar los ingresos netos para financiar el desarrollo continuo de Multikine, su terapia de primera línea contra el cáncer que ha recibido la designación de Medicamento Huérfano de la FDA para terapia neoadyuvante en pacientes con cáncer de cabeza y cuello. La FDA ha aprobado los planes de CEL-SCI para un estudio de registro confirmatorio de 212 pacientes con cáncer de cabeza y cuello resecable, localmente avanzado y sin tratamiento previo.
CEL-SCI (NYSE American: CVM)는 $0.31 주당 16,130,000주의 보통주(또는 선불 워런트)의 최선의 공모를 발표하며, 약 $5 백만의 총 수익을 올릴 것으로 기대하고 있습니다. 이번 공모는 2024년 12월 31일에 종료될 예정이며, ThinkEquity가 유일한 배치 에이전트로 활동합니다.
회사는 순 수익을 사용하여 Multikine의 지속적인 개발을 지원할 계획입니다. 이는 FDA의 고형종양 치료제로서의 오르판 약물 지정을 받은 첫 번째 치료법입니다. FDA는 새롭게 진단된 지역 진행성이며 수술 가능한 암 치료를 위해 212명의 환자를 대상으로 하는 확인 등록 연구 계획을 CEL-SCI에 승인했습니다.
CEL-SCI (NYSE American: CVM) a annoncé une offre publique de 16 130 000 actions ordinaires (ou bons de souscription préfinancés) à 0,31 $ par action, s’attendant à lever environ 5 millions $ de produit brut. L’offre doit se clore le 31 décembre 2024, avec ThinkEquity agissant en tant qu’agent de placement exclusif.
L’entreprise prévoit d’utiliser les produits nets pour financer le développement continu de Multikine, leur traitement contre le cancer de première ligne qui a reçu la désignation de Médicament Orphelin par la FDA pour le traitement néoadjuvant chez les patients atteints de cancer de la tête et du cou. La FDA a approuvé les plans de CEL-SCI pour une étude d’enregistrement confirmatoire de 212 patients atteints de cancer de la tête et du cou, localement avancé et opérable mais n’ayant jamais été traités.
CEL-SCI (NYSE American: CVM) gab eine öffentliche Angebotserklärung für 16.130.000 Aktien des Stammkapitals (oder vorfinanzierte Warrants) zu einem Preis von $0,31 pro Aktie bekannt, mit der Erwartung, etwa $5 Millionen an Bruttoerlösen zu erzielen. Das Angebot soll am 31. Dezember 2024 geschlossen werden, wobei ThinkEquity als alleiniger Platzierungsagent fungiert.
Das Unternehmen plant, die Nettomittel zur Finanzierung der fortgesetzten Entwicklung von Multikine zu verwenden, ihrer erstmaligen Krebstherapie, die von der FDA den Status eines Waisenmedikaments für die neoadjuvante Therapie bei Patienten mit Kopf- und Halskrebs erhalten hat. Die FDA hat die Pläne von CEL-SCI für eine Bestätigungsregistrierungsstudie von 212 Patienten mit neu diagnostiziertem lokal fortgeschrittenem primär behandlungsnaiven resezierbaren Kopf- und Halskrebs genehmigt.
Positive
- FDA approval for confirmatory Registration Study with 212 patients
- Multikine has Orphan Drug designation from FDA
- Target market of approximately 100,000 patients annually
- $5 million capital raise to support Multikine development
Negative
- Dilutive offering of 16.13 million shares at $0.31 per share, significantly below recent trading prices
- Best-efforts offering structure indicates potential uncertainty in completing the full raise
- Additional funding may be needed for complete development program
Insights
<p>This <money>$5 million</money> public offering at <money>$0.31</money> per share represents significant dilution for existing shareholders, as it adds 16.13 million new shares to a company with a market cap of only <money>$45 million</money>. The pricing reflects a substantial discount to recent trading levels, indicating weak demand and challenging market conditions. The timing, coming at year-end, suggests urgent capital needs for their Multikine development program.</p><p>The use of pre-funded warrants alongside common stock is a complex financing structure typically employed when companies face difficulties raising capital through traditional means. This financing provides essential working capital but comes at a high cost to shareholder value. The dilution impact is particularly severe given the company’s small market capitalization.</p>
<p>The capital raise is important for advancing the 212-patient Registration Study for Multikine in head and neck cancer, targeting a specific subset of patients with no lymph node involvement and low PD-L1 expression. This narrow patient selection criteria, while potentially improving success chances, limits the addressable market to approximately 100,000 patients annually.</p><p>The FDA’s concurrence with the patient selection criteria and study design provides some validation, but the financing terms reflect market skepticism about Multikine’s commercial prospects despite its Orphan Drug designation. The focus on treatment-naïve patients in the neoadjuvant setting is scientifically sound, but the path to market remains challenging given the competitive landscape in head and neck cancer immunotherapy.</p>
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 a best-efforts public offering of 16,130,000 shares of its common stock (or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof). Each share of common stock (or Pre-Funded Warrant) is being sold at a public offering price of $0.31 per share (inclusive of the Pre-Funded Warrant exercise price). Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $5,000,000. The offering is expected to close on December 31, 2024, 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 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 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.
Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, 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 which will enroll 212 patients. CEL-SCI will enroll 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 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, 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/20241229624932/en/
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Source: CEL-SCI Corporation
FAQ
What is the size and price of CEL-SCI’s (CVM) December 2023 public offering?
CEL-SCI’s public offering consists of 16,130,000 shares priced at $0.31 per share, aiming to raise approximately $5 million in gross proceeds.
How will CEL-SCI (CVM) use the proceeds from its $5 million offering?
CEL-SCI will use the net proceeds to fund the continued development of Multikine, general corporate purposes, and working capital.
What is the target patient population for CEL-SCI’s (CVM) Multikine 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 and low PD-L1 tumor expression.
How many patients have been treated with CEL-SCI’s (CVM) Multikine therapy?
Multikine has been dosed in over 740 patients and has received FDA Orphan Drug designation for head and neck cancer therapy.
What is the market size for CEL-SCI’s (CVM) Multikine treatment?
The target patient population represents approximately 100,000 patients annually.
