CEL-SCI Announces Closing of $5 Million Offering
CEL-SCI (NYSE American: CVM) has closed its previously announced best-efforts offering, raising approximately $5 million in gross proceeds through the sale of 16,130,000 shares of common stock (or pre-funded warrants) at $0.31 per share. The proceeds will fund the development of Multikine, a first-line cancer therapy that has received FDA Orphan Drug designation for head and neck cancer treatment, along with general corporate purposes and working capital. ThinkEquity served as the sole placement agent. The offering was conducted under the company's effective shelf registration statement. The company is preparing for a confirmatory Registration Study of 212 patients focusing on newly diagnosed head and neck cancer patients with specific criteria.
CEL-SCI (NYSE American: CVM) ha concluso la sua offerta a migliore sforzo precedentemente annunciata, raccogliendo circa $5 milioni in proventi lordi attraverso la vendita di 16.130.000 azioni comuni (o warrant prefinanziati) a $0,31 per azione. I proventi finanzieranno lo sviluppo di Multikine, una terapia oncologica di prima linea che ha ricevuto la designazione di farmaco orfano dalla FDA per il trattamento del cancro della testa e del collo, insieme a fini aziendali generali e capitale di esercizio. ThinkEquity ha svolto il ruolo di unico agente di collocamento. L'offerta 猫 stata effettuata sotto la dichiarazione di registrazione efficace dell'azienda. L'azienda si sta preparando per uno studio di registrazione di conferma su 212 pazienti focalizzato su pazienti con cancro della testa e del collo appena diagnosticati con criteri specifici.
CEL-SCI (NYSE American: CVM) ha cerrado su oferta previa anunciada de mejores esfuerzos, recaudando aproximadamente $5 millones en ingresos brutos a trav茅s de la venta de 16.130.000 acciones comunes (o warrants prefinanciados) a $0.31 por acci贸n. Los ingresos financiar谩n el desarrollo de Multikine, una terapia contra el c谩ncer de primera l铆nea que ha recibido la designaci贸n de medicamento hu茅rfano por parte de la FDA para el tratamiento del c谩ncer de cabeza y cuello, junto con prop贸sitos corporativos generales y capital de trabajo. ThinkEquity actu贸 como el 煤nico agente de colocaci贸n. La oferta se llev贸 a cabo bajo la declaraci贸n de registro efectiva de la compa帽铆a. La compa帽铆a se est谩 preparando para un estudio de registro confirmatorio de 212 pacientes enfocado en pacientes reci茅n diagnosticados con c谩ncer de cabeza y cuello con criterios espec铆ficos.
CEL-SCI (NYSE American: CVM)電 鞚挫爠鞐 氚滍憸霅 斓滌劆鞚 雲鸽牓 鞝滉车鞚 膦呺頃橁碃 鞎 $5 氚彪鞚 16,130,000欤(霕愲姅 鞛愱笀 歆鞗愲悳 氤挫靹)鞚 氤错喌欤 毵り皝鞚 韱淀暣 欤茧嫻 $0.31鞐 氇笀頃橃榾鞀惦媹雼. 靾橃澋旮堨潃 FDA 瓿犾晞鞎 歆鞝曥潉 氚涭潃 Multikine鞚 臧滊皽鞚 歆鞗愴晿氅, 鞚措姅 毹鸽Μ鞕 氇╈潣 鞎 旃橂毳 鞙勴暅 觳 氩堨Ц 旃橂氩曥瀰雼堧嫟. 鞚茧皹 旮办梾 氇╈爜 氚 鞖挫榿 鞛愲掣瓿 頃粯 靷毄霅╇媹雼. ThinkEquity電 鞙犾澕頃 氚办箻 鞐愳澊鞝勴姼搿 頇滊彊頄堨姷雼堧嫟. 鞚 鞝滉车鞚 須岇偓鞚 鞙犿毃頃 靹犽皹 霌彪 觳洂靹滌棎 霐半澕 鞚措(鞏挫鞀惦媹雼. 鞚 須岇偓電 韸轨爼 旮办鞚 臧歆 靸堧 歆勲嫧霅 毹鸽Μ 氚 氇 鞎 頇橃瀽 212氇呾潉 雽靸侅溂搿 頃橂姅 頇曥澑 霌彪 鞐瓣惮毳 欷牍勴晿瓿 鞛堨姷雼堧嫟.
CEL-SCI (NYSE American: CVM) a cl么tur茅 son offre annonc茅e par le biais des meilleurs efforts, levant environ $5 millions de produits bruts gr芒ce 脿 la vente de 16.130.000 actions ordinaires (ou bons d'option pr茅financ茅s) 脿 0,31 $ par action. Les produits financeront le d茅veloppement de Multikine, une th茅rapie anticanc茅reuse de premi猫re ligne qui a re莽u la d茅signation de m茅dicament orphelin de la FDA pour le traitement du cancer de la t锚te et du cou, ainsi que des fins commerciales g茅n茅rales et un fonds de roulement. ThinkEquity a agi en tant qu'agent de placement exclusif. L'offre a 茅t茅 r茅alis茅e sous la d茅claration d'enregistrement de l'entreprise effective. L'entreprise se pr茅pare 脿 une 茅tude de validation de l'enregistrement portant sur 212 patients ax茅e sur des patients r茅cemment diagnostiqu茅s avec un cancer de la t锚te et du cou r茅pondant 脿 certains crit猫res.
CEL-SCI (NYSE American: CVM) hat sein zuvor angek眉ndigtes Angebot erfolgreicher Bem眉hungen abgeschlossen und rund $5 Millionen an Bruttoeinnahmen durch den Verkauf von 16.130.000 Stammaktien (oder vorfinanzierten Optionsscheinen) zu einem Preis von $0,31 pro Aktie gesammelt. Die Einnahmen flie脽en in die Entwicklung von Multikine, einer Erstlinientherapie gegen Krebs, die von der FDA die Orphan Drug-Bezeichnung f眉r die Behandlung von Kopf- und Halskrebs erhalten hat, sowie in allgemeine Unternehmenszwecke und Betriebskapital. ThinkEquity fungierte als alleiniger Platzierungsagent. Das Angebot wurde gem盲脽 dem effektiven Shelf-Registrierungsstatement des Unternehmens durchgef眉hrt. Das Unternehmen bereitet sich auf eine best盲tigende Registrierungstudie mit 212 Patienten vor, die sich auf neu diagnostizierte Patienten mit Kopf- und Halskrebs mit bestimmten Kriterien konzentriert.
- Secured $5 million in funding through stock offering
- FDA approved confirmatory Registration Study for Multikine
- Maintains Orphan Drug designation for head and neck cancer therapy
- Significant shareholder dilution through 16.13 million new shares
- Low share price of $0.31 indicates market weakness
- Additional capital may be needed for future operations
Insights
The
The offering's structure using pre-funded warrants suggests institutional investors wanted downside protection, indicating cautious sentiment about near-term prospects. The use of ThinkEquity as the sole placement agent, rather than a larger investment bank, also reflects institutional interest. The primary concern is whether this capital will be sufficient for meaningful clinical progress, given the company's historical burn rate and the costs associated with the planned 212-patient registration study.
The funding secured will support the confirmatory Registration Study for Multikine in head and neck cancer, targeting a highly specific patient population: newly diagnosed, locally advanced, treatment-na茂ve patients with no lymph node involvement and low PD-L1 expression. This precise patient selection, endorsed by the FDA, represents a strategic pivot to focus on approximately 100,000 annual cases where Multikine may demonstrate optimal efficacy.
The regulatory pathway appears derisked with FDA's concurrence on patient selection criteria, though the narrow patient population could impact commercial potential. The immunotherapy approach of boosting the immune system before it's compromised by standard treatments is mechanistically sound, but previous clinical setbacks have created market skepticism. The 212-patient study size is relatively modest for a registration trial, suggesting efficient capital deployment, but also highlighting the need for compelling efficacy data to overcome historical challenges.
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 acted as sole placement agent for the offering.
The securities were offered and sold pursuant to the Company鈥檚 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 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 use of proceeds 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.
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Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Source: CEL-SCI Corporation
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