CEL-SCI Announces Pricing of $5 Million Public Offering
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 na茂ve resectable head and neck cancer.
CEL-SCI (NYSE American: CVM) ha annunciato un'offerta pubblica a esfor莽o 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 societ脿 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) anunci贸 una oferta p煤blica de mejor esfuerzo de 16,130,000 acciones de acciones ordinarias (o warrants prefinanciados) a $0.31 por acci贸n, esperando recaudar aproximadamente $5 millones en ingresos brutos. La oferta est谩 programada para cerrar el 31 de diciembre de 2024, con ThinkEquity actuando como 煤nico agente de colocaci贸n.
La empresa planea utilizar los ingresos netos para financiar el desarrollo continuo de Multikine, su terapia de primera l铆nea contra el c谩ncer que ha recibido la designaci贸n de Medicamento Hu茅rfano de la FDA para terapia neoadyuvante en pacientes con c谩ncer de cabeza y cuello. La FDA ha aprobado los planes de CEL-SCI para un estudio de registro confirmatorio de 212 pacientes con c谩ncer de cabeza y cuello resecable, localmente avanzado y sin tratamiento previo.
CEL-SCI (NYSE American: CVM)电 $0.31 欤茧嫻 16,130,000欤检潣 氤错喌欤(霕惖鐢 靹犽秷 鞗岆煱韸)鞚 斓滌劆鞚 瓿惦毳 氚滍憸頃橂┌, 鞎 $5 氚彪鞚 齑 靾橃澋鞚 鞓Υ 瓴冹溂搿 旮半寑頃橁碃 鞛堨姷雼堧嫟. 鞚措矆 瓿惦电 2024雲 12鞗 31鞚检棎 膦呺霅 鞓堨爼鞚措┌, ThinkEquity臧 鞙犾澕頃 氚办箻 鞐愳澊鞝勴姼搿 頇滊彊頃╇媹雼.
須岇偓电 靾 靾橃澋鞚 靷毄頃橃棳 Multikine鞚 歆靻嶌爜鞚 臧滊皽鞚 歆鞗愴暊 瓿勴殟鞛呺媹雼. 鞚吹鐢 FDA鞚 瓿犿槙膦呾枒 旃橂鞝滊靹滌潣 鞓るゴ韺 鞎诫 歆鞝曥潉 氚涭潃 觳 氩堨Ц 旃橂氩曥瀰雼堧嫟. FDA电 靸堧…瓴 歆勲嫧霅 歆鞐 歆勴枆靹膘澊氅 靾橃垹 臧電ロ暅 鞎 旃橂毳 鞙勴暣 212氇呾潣 頇橃瀽毳 雽靸侅溂搿 頃樀鐢 頇曥澑 霌彪 鞐瓣惮 瓿勴殟鞚 CEL-SCI鞐 鞀轨澑頄堨姷雼堧嫟.
CEL-SCI (NYSE American: CVM) a annonc茅 une offre publique de 16 130 000 actions ordinaires (ou bons de souscription pr茅financ茅s) 脿 0,31 $ par action, s'attendant 脿 lever environ 5 millions $ de produit brut. L'offre doit se clore le 31 d茅cembre 2024, avec ThinkEquity agissant en tant qu'agent de placement exclusif.
L'entreprise pr茅voit d'utiliser les produits nets pour financer le d茅veloppement continu de Multikine, leur traitement contre le cancer de premi猫re ligne qui a re莽u la d茅signation de M茅dicament Orphelin par la FDA pour le traitement n茅oadjuvant chez les patients atteints de cancer de la t锚te et du cou. La FDA a approuv茅 les plans de CEL-SCI pour une 茅tude d'enregistrement confirmatoire de 212 patients atteints de cancer de la t锚te et du cou, localement avanc茅 et op茅rable mais n'ayant jamais 茅t茅 trait茅s.
CEL-SCI (NYSE American: CVM) gab eine 枚ffentliche Angebotserkl盲rung f眉r 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 Bruttoerl枚sen 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 f眉r die neoadjuvante Therapie bei Patienten mit Kopf- und Halskrebs erhalten hat. Die FDA hat die Pl盲ne von CEL-SCI f眉r eine Best盲tigungsregistrierungsstudie von 212 Patienten mit neu diagnostiziertem lokal fortgeschrittenem prim盲r behandlungsnaiven resezierbaren Kopf- und Halskrebs genehmigt.
- 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
- 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
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.
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.
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.
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-na茂ve 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.
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鈥檚 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鈥檚 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 na茂ve 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, 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:
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
听
Source: CEL-SCI Corporation
FAQ
What is the size and price of CEL-SCI's (CVM) December 2023 public offering?
How will CEL-SCI (CVM) use the proceeds from its $5 million offering?
What is the target patient population for CEL-SCI's (CVM) Multikine Registration Study?
How many patients have been treated with CEL-SCI's (CVM) Multikine therapy?