Cel-Sci Corporation - CVM STOCK NEWS

CEL-SCI Corporation (NYSE American: CVM) presented its poster on the IT-MATTERS study at the ASCO 2022 Annual Meeting in Chicago, discussing the immunotherapy Multikine®'s role in extending overall survival for low-risk locally advanced squamous cell carcinoma of the head and neck. The findings indicate a 14.1% overall survival advantage over standard care after five years, with significant safety results. CEL-SCI plans to submit a Biologic License Application to the FDA based on this Phase 3 study, which is considered the largest of its kind for this indication.

CEL-SCI Corporation (NYSE American: CVM) announced the publication of two abstracts at the ASCO Annual Meeting, which will be presented by Dr. Eyal Talor. The abstracts focus on the pivotal Phase 3 Multikine clinical trial for head and neck cancer, highlighting a study that shows immunotherapy can extend overall survival in low-risk patients. The Phase 3 study, which began in 2011 and enrolled 928 patients, aims to prove survival benefits by monitoring death events.

Multikine, a unique investigational product, received Orphan Drug designation from the FDA for its neoadjuvant therapy approach.

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.