Welcome to our dedicated page for CEL-SCI news (Ticker: CVM), a resource for investors and traders seeking the latest updates and insights on CEL-SCI stock.
CEL-SCI Corporation (NYSE American: CVM) is a clinical stage cancer immunotherapy company whose news flow centers on the development, financing, and regulatory progress of its lead investigational product, Multikine (Leukocyte Interleukin, Injection). As a developer of biological products for head and neck cancer, CEL-SCI regularly issues updates on clinical plans, regulatory interactions, and capital markets activity that are relevant to investors and observers of the biotechnology sector.
News releases from CEL-SCI highlight key milestones for Multikine, including the completed Phase 3 study in head and neck cancer, the FDA’s concurrence on target patient selection criteria, and preparations for a 212-patient confirmatory Registration Study in newly diagnosed locally advanced head and neck cancer patients with specific PD-L1 and lymph node characteristics. The company also reports on efforts to seek early approval in the U.S. based on pre-surgical tumor response data and cites third-party scientific publications that support its development strategy.
CEL-SCI’s news coverage features international regulatory developments, particularly in the Kingdom of Saudi Arabia. The company has announced the filing of a Breakthrough Medicine Designation application for Multikine with the Saudi Food and Drug Authority through a local pharmaceutical partner, a Memorandum of Understanding for commercialization in Saudi Arabia, and growing interest from Saudi investment funds and potential joint ventures aligned with Saudi Arabia’s Vision 2030 and National Biotechnology Strategy.
In addition, CEL-SCI issues frequent updates on public offerings of common stock, including pricing and closing announcements, and related Form S-3 shelf registration usage. These items provide insight into how the company funds the continued development of Multikine, as well as its general corporate purposes and working capital. Visitors to this news page can review a chronological record of CEL-SCI’s clinical, regulatory, partnership, and financing announcements related to CVM.
CEL-SCI Corporation (NYSE American: CVM) has successfully closed the offering of 1,400,000 shares of its common stock at a price of $22.62 per share, amounting to approximately $31.7 million in gross proceeds. The underwriter, Kingswood Capital Markets, has a 30-day option to purchase an additional 210,000 shares to cover over-allotments. This offering was made under a 'shelf' registration statement with the SEC. CEL-SCI is focused on developing immunotherapy treatments, with its lead therapy, Multikine, in a pivotal Phase 3 trial for head and neck cancer.
CEL-SCI Corporation (NYSE American: CVM) announced an increased public offering of 1,400,000 shares of common stock at $22.62 per share, a 5% discount to the last closing price. The offering, expected to close around June 11, 2021, will fund the development of Multikine and other corporate purposes. Kingswood Capital Markets is the sole book-runner. The offering is registered under an S-3 shelf registration. Investors are reminded that the offering is subject to market conditions and other risks.
CEL-SCI Corporation (NYSE American: CVM) announced an underwriting agreement with Kingswood Capital Markets to sell a minimum of 1,000,000 shares at $22.62 per share, a 5% discount from the June 8, 2021 closing price. The offering is set to close around June 11, 2021, subject to customary conditions. A 30-day option is granted to purchase an additional 15%. Proceeds will fund the development of Multikine and other corporate purposes. The shares are offered under a "shelf" registration statement with the SEC.
CEL-SCI Corporation (NYSE American: CVM) announced its financial results for Q2 2021, reporting an operating loss of $8.5 million, up from $6.7 million in Q2 2020. For the six months ended March 31, 2021, losses reached $17.3 million, compared to $13.6 million in the prior year. The company is in the statistical analysis phase of its Phase 3 head and neck cancer study of Multikine, with plans for a commercial launch following the completion of its $10.6 million manufacturing facility upgrade.
CEL-SCI Corporation (NYSE American: CVM) reported its financial results for the quarter ending December 31, 2020, highlighting key clinical developments.
Notably, the Phase 3 head and neck cancer study for Multikine is in statistical analysis, following data lock completion. The company also expanded its cGMP facility to double production capacity. Financially, CEL-SCI recorded a net loss of approximately $7.9 million, compared to $5.5 million for the same quarter in 2019. Cash reserves stood at approximately $21.9 million as of December 31, 2020, bolstered by a public offering that raised about $13.6 million.
CEL-SCI Corporation (NYSE American: CVM) announced that CEO Geert Kersten will present at the 2021 H.C. Wainwright BIOCONNECT Virtual Conference from January 11-14, 2021. The presentation will be available on-demand starting January 11 at 6:00 AM ET. CEL-SCI's Phase 3 study focuses on Multikine, an investigational cancer immunotherapy specifically targeting advanced squamous cell carcinoma of the head and neck. The study aims to boost patients' immune responses before undergoing standard treatments, with 928 patients fully enrolled as of September 2016.
CEL-SCI Corporation (NYSE American: CVM) has issued a letter to shareholders emphasizing its investigational cancer immunotherapy, Multikine. The company aims to improve survival rates for head and neck cancer through early immune system activation before conventional treatments. It is finalizing results from a pivotal Phase 3 study, which has taken nearly a decade to complete. The letter highlights the complexity of the study, including past challenges with a CRO, and reassures stakeholders of ongoing FDA oversight and positive expectations for Multikine's efficacy.
CEL-SCI Corporation (CVM) reported its fiscal year 2020 results, highlighting key developments in its Phase 3 study of Multikine for head and neck cancer. The study reached a crucial milestone with 298 events, leading to data analysis. The company raised approximately $25.8 million in 2020 and an additional $14.7 million post-fiscal year. However, CEL-SCI recorded a net loss of $30.3 million, up from $22.1 million in 2019, primarily due to increased R&D and administrative expenses. The company is also advancing LEAPS immunotherapy for COVID-19 and rheumatoid arthritis.
CEL-SCI Corporation (NYSE American: CVM) announced its presentation at the 13th Annual LD Micro Main Event Conference on December 15, 2020, at 10:00 a.m. ET, featuring CEO Geert Kersten. The virtual presentation will include a 10-minute overview followed by a Q&A session. CEL-SCI's Phase 3 study of its investigational product, Multikine, aims to treat newly diagnosed advanced primary squamous cell carcinoma of the head and neck. It is noted as the largest Phase 3 study of its kind, fully enrolled with 928 patients. The study is currently in the statistical analysis phase.
CEL-SCI Corporation (NYSE American:CVM) announced its participation at the LD 500 investor conference on September 2, 2020, at 10:20 a.m. ET. CEO Geert Kersten will present to a virtual audience, with a live audio webcast available. CEL-SCI is conducting a Phase 3 study of Multikine for advanced primary squamous cell carcinoma of the head and neck, uniquely administering it before conventional therapies. The study has enrolled 928 patients, and data analysis is currently underway following 298 survival events in April 2020.
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