Cel-Sci Corporation - CVM STOCK NEWS

CEL-SCI Corporation (AMEX: CVM) announced its financial results for the quarter ending December 31, 2022. Key highlights include successful clinical outcomes for Multikine, with five patients achieving complete cancer clearance and 40 demonstrating significant tumor reduction. The company prepares to submit a Biologic License Application (BLA) to the FDA, as its Phase 3 study shows a median overall survival improvement of 46.5 months for Multikine patients. Financially, CEL-SCI reported a net operating loss of $7.7 million and $18 million in cash reserves.

CEL-SCI Corporation (NYSE American: CVM) reported fiscal year 2022 results, focusing on the submission of a Biologics License Application for its product, Multikine, targeting advanced primary head and neck cancer. The Phase 3 trial showed significant survival benefits, with a median overall survival improvement of 46.5 months. Financially, the company had a net operating loss of $36.1 million. As of September 30, 2022, CEL-SCI was holding $22.7 million in cash. Despite challenges, the company aims to expedite its regulatory submission and leverage positive trial outcomes.

CEL-SCI Corporation (NYSE American: CVM) announced significant progress regarding its investigational drug Multikine for treating locally advanced primary squamous cell carcinoma of the head and neck. The Phase 3 trial showed a median overall survival improvement of 46.5 months, with 62.7% of patients alive after five years. Multikine is positioned as a neoadjuvant therapy, unlike competitors’ treatments, which are for recurrent tumors. Despite challenges due to limited resources compared to larger firms, the company remains committed to advancing Multikine’s approval for patient benefit.

CEL-SCI Corporation (NYSE American: CVM) reported significant findings from its Phase 3 IT-MATTERS study at the ESMO Annual Congress on September 10, 2022. The investigational drug Multikine showed promising results in treating locally advanced primary head and neck cancer, with 5 patients achieving complete tumor response after 3 weeks of treatment, confirmed at surgery. Additionally, 40 patients exhibited partial tumor reductions exceeding 30%. The findings indicate that early responses to Multikine treatment are prognostic for overall survival, supporting the company's plans for a Biologics License Application to the FDA.

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.