CEL-SCI Corp Stock Price, News & Analysis

CEL-SCI Corporation (NYSE American: CVM) presented two posters at the European Society for Medical Oncology Congress on September 10, 2022, highlighting results from its pivotal Phase 3 IT-MATTERS study. This study, focusing on neoadjuvant Leukocyte Interleukin Injection for squamous cell carcinoma of the head and neck, showed early tumor response indicating overall survival benefits. Outcomes included 45 documented neoadjuvant responses, with significant advantages seen in lower risk patients, and promising biomarker analyses supporting Multikine efficacy.

CEL-SCI Corporation (NYSE American: CVM) reported significant results from its Phase 3 study of Multikine, an investigational cancer immunotherapy for head and neck cancer. The therapy demonstrated a notable reduction and elimination of tumors within three weeks for some patients. Furthermore, a nearly four-year median overall survival benefit was observed in the radiation-only group, with more than 80% of responders alive at the study's end. CEL-SCI plans to submit a major follow-up package to the FDA soon, addressing questions and comments received, highlighting the urgency for improved treatment options.

CEL-SCI Corporation (CVM) announced results from its pivotal Phase 3 IT-MATTERS trial for Multikine, an investigational immunotherapy for advanced primary head and neck cancer. The study demonstrated a 14.1% absolute overall survival (OS) advantage at five years for patients deemed lower risk for recurrence, with a median OS of 101.7 months compared to 55.2 months for standard treatment. Multikine showed a significant objective response rate and reduced death rates among responders. The proposed indication could benefit around 210,000 patients annually.

CEL-SCI Corporation (NYSE American: CVM) reported financial results for Q2 2022, with an operating loss of $8.7 million, improving from $10.5 million in Q2 2021. For the nine-month period, the loss was $27.1 million, down from $27.7 million year-over-year. Key clinical developments include two ASCO abstracts demonstrating Multikine's (Leukocyte Interleukin) significant survival benefit in head and neck cancer patients. The treatment showed a statistically significant tumor response before surgery, with a p-value of less than 0.00000000001. The company’s cGMP facility is undergoing validation, ensuring compliance with FDA and European regulations.

CEL-SCI Corporation (NYSE American: CVM) announces CEO Geert Kersten will participate in a Reddit AMA at 12:30 PM ET today to discuss Multikine and recent ASCO 2022 publications.

Multikine, designed to enhance immune response in patients with advanced head and neck cancer, received FDA Orphan Drug designation for neoadjuvant therapy. The ongoing Phase 3 study, initiated in 2011, enrolled 928 patients and aims to demonstrate a survival benefit. Previous results showed positive outcomes for patients treated with Multikine plus standard therapies, although adding chemotherapy negated benefits.

CEL-SCI Corporation (NYSE American: CVM) announced that CEO Geert Kersten will present at the LD Micro Invitational XII Conference on June 8, 2022, at 4:30 p.m. EDT in Westlake Village, CA. The conference runs from June 7-9, 2022. Interested parties can watch the presentation live at ldinv12.mysequire.com or on the CEL-SCI's Investor Relations website. CEL-SCI is advancing a Phase 3 cancer immunotherapy, Multikine, targeting advanced primary squamous cell carcinoma of the head and neck, with promising study results highlighting survival benefits.

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.