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) reported its financial results for the quarter ending March 31, 2022, revealing an operating loss of $9.6 million, up from $8.5 million in Q1 2021. The company highlighted two accepted abstracts for its Multikine® head and neck cancer trial, demonstrating a statistically significant survival benefit of 14.1% at five years. As of March 31, 2022, CEL-SCI had $34.3 million in cash. The company’s cGMP facility is undergoing validation to meet FDA and European regulations, with a regulatory filing for Multikine anticipated soon.
CEL-SCI Corporation (NYSE American: CVM) announced acceptance of two abstracts related to its Phase 3 clinical trial for head and neck cancer at the American Society of Clinical Oncology (ASCO) meeting from June 3-7, 2022, in Chicago, IL. Over 890,000 new cases of head and neck cancer are diagnosed annually worldwide, with 68,000 in the U.S. CEL-SCI's Multikine, an investigational immunotherapy, targets early intervention before conventional treatments, aiming to enhance survival rates. The pivotal study enrolled 928 patients, marking it as the largest of its kind globally.
CEL-SCI Corporation (NYSE American: CVM) reported its financial results for Q1 ended December 31, 2021. Highlights include the completion of a cGMP facility to double Multikine's production capacity in anticipation of regulatory approval. The company plans to file a Biologic License Application based on promising Phase 3 study results showing a significant survival benefit for head and neck cancer patients. However, net loss for the quarter rose to $8.8 million from $8.0 million year-over-year, with total operating expenses reaching $8.8 million.
CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2021, revealing a net loss of $36.4 million, up from $30.3 million in 2020. The increase in the loss was driven by a 30% rise in R&D expenses, totaling $23.1 million, and a 12% increase in general and administrative costs. Despite this, CEL-SCI successfully completed the expansion of its cGMP manufacturing facility for Multikine, which is crucial for its anticipated regulatory approval. The company raised approximately $54.1 million in 2021 and ended the fiscal year with $42.2 million in cash and equivalents.
CEL-SCI Corporation (NYSE American: CVM) has completed an expansion of its dedicated Multikine manufacturing facility in Vienna, Virginia. This expansion, a result of an $11 million investment, doubles production capacity to meet expected market demand following a potential Biologics License Application (BLA) for Multikine. The renovations ensure compliance with FDA standards and anticipate hiring additional staff. Multikine is being studied as a neoadjuvant treatment for advanced primary head and neck cancer, with positive results from a pivotal Phase 3 study reported in June 2021.
CEL-SCI Corporation (CVM) announced its financial results for the quarter ending June 30, 2021, highlighting a significant milestone in its Phase 3 study of Multikine for head and neck cancer. The study demonstrated a 14.1% improvement in 5-year overall survival for patients treated with Multikine compared to controls. CEL-SCI plans to file a Biologic License Application with the FDA, targeting approximately 210,000 patients annually. The company reported an operating loss of $27.7 million for the nine months ending June 30, 2021, a rise from $20.5 million in the previous year.
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.
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