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 develops cancer immunotherapy programs centered on Multikine (Leukocyte Interleukin, Injection), an investigational neoadjuvant therapy for squamous cell carcinoma of the head and neck. Company news commonly covers Multikine regulatory interactions, FDA Orphan Drug designation for neoadjuvant use, confirmatory registration-study preparation, and the company's positioning of the therapy before surgery, radiation, and chemotherapy.
Updates also include financial results, public equity offerings used to fund Multikine development, investor presentations, and regional commercialization or regulatory-affairs agreements, including activity in Saudi Arabia. CEL-SCI's disclosures often connect clinical development with working-capital needs and potential international market access.
CEL-SCI Corporation (NYSE American: CVM) reported significant results from its Phase 3 trial of Multikine in advanced primary head and neck cancer, demonstrating a 14.1% increase in 5-year survival rates (62.7% vs 48.6%) for patients receiving the therapy plus standard treatment. The company plans to file for FDA approval based on these findings. Multikine is an investigational immunotherapy containing multiple cytokines, aimed at enhancing the immune response before surgery and radiotherapy. The discussion of results took place at the Annual Shareholder Meeting on July 1, 2021.
CEL-SCI Corporation (NYSE American: CVM) announced it will discuss its Phase 3 head and neck cancer trial results post its Annual Shareholder Meeting on July 1, 2021. The trial showed a significant 14.1% 5-year survival benefit (62.7% vs 48.6%) for patients receiving surgery plus radiotherapy after treatment with Multikine®. The company plans to file for FDA approval in this patient group. Multikine is an investigational immunotherapy designed to enhance immune response against cancer, manufactured under strict GMP standards.
CEL-SCI Corporation (NYSE American: CVM) announced results from a pivotal 9.5-year Phase 3 study of its immunotherapy Multikine for advanced primary squamous cell carcinoma of the head and neck. The treatment demonstrated a statistically significant 14.1% overall survival benefit (OS) at 5 years (62.7%) for patients not receiving chemotherapy. The study enrolled 928 patients across 78 sites, showing no safety issues. Although the overall trial did not meet the primary endpoint, the results for the chemotherapy-free subgroup warrant an FDA approval request, highlighting an unmet medical need for around 155,000 patients annually.
CEL-SCI Corporation (NYSE American: CVM) is hosting its Annual Shareholder Meeting on July 1, 2021, at 10:00 a.m. EDT. Participants can submit questions until June 29, 2021, at 5:00 p.m. EDT via email. Due to COVID-19 concerns, the meeting will be hybrid, held both in-person and virtually. CEL-SCI is focused on cancer immunotherapy with its lead product, Multikine, in a pivotal Phase 3 trial for head and neck cancer, having received FDA Orphan Drug Status.
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.