CEL-SCI Corp Stock Price, News & Analysis

CEL-SCI (CVM) reported fiscal year 2024 results and announced preparations for a 212-patient Confirmatory Registration Study for Multikine in head and neck cancer patients. The study, expected to complete enrollment by Q2 2026, focuses on PD-L1 low newly diagnosed patients.

Key financial results include a reduced net loss of $26.9 million compared to $32.2 million in 2023. Research and development expenses decreased 19% to $18.2 million, while general and administrative expenses fell 9% to $8.2 million.

The FDA has approved the confirmatory study based on previous Phase 3 results, where Multikine demonstrated 73% survival rate versus 45% in control patients at 5 years. The company plans to seek early approval based on pre-surgical response rates and aims to establish Multikine as the first new treatment in over 50 years for newly diagnosed locally advanced head and neck cancer.

CEL-SCI (NYSE American: CVM) has closed its previously announced best-efforts offering, raising approximately $5 million in gross proceeds through the sale of 16,130,000 shares of common stock (or pre-funded warrants) at $0.31 per share. The proceeds will fund the development of Multikine, a first-line cancer therapy that has received FDA Orphan Drug designation for head and neck cancer treatment, along with general corporate purposes and working capital. ThinkEquity served as the sole placement agent. The offering was conducted under the company's effective shelf registration statement. The company is preparing for a confirmatory Registration Study of 212 patients focusing on newly diagnosed head and neck cancer patients with specific criteria.

CEL-SCI (NYSE American: CVM) announced a best-efforts public offering of 16,130,000 shares of common stock (or pre-funded warrants) at $0.31 per share, expecting to raise approximately $5 million in gross proceeds. The offering is set to close on December 31, 2024, with ThinkEquity acting as sole placement agent.

The company plans to use the net proceeds to fund the continued development of Multikine, their first-line cancer therapy which has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck cancer patients. The FDA has approved CEL-SCI's plans for a confirmatory Registration Study of 212 patients with newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer.

CEL-SCI (NYSE American: CVM), a clinical stage cancer immunotherapy company, has announced its intention to conduct a best efforts public offering of common stock and/or pre-funded warrants. The company plans to use the net proceeds to fund the continued development of Multikine, general corporate purposes, and working capital. ThinkEquity is serving as the sole placement agent for the offering. The securities will be offered through a shelf registration statement on Form S-3 filed with the SEC. The completion, size, and terms of the offering are subject to market conditions and are not guaranteed.

CEL-SCI (NYSE American: CVM) has received FDA approval for a 212-patient confirmatory registration study of Multikine in head and neck cancer treatment. The study focuses on patients who showed a 73% survival rate with Multikine versus 45% in control groups during the prior Phase 3 study.

The study will target newly diagnosed locally advanced primary (stage III and IVa) head and neck cancer patients with no lymph node involvement and low PD-L1 tumor expression. Multikine demonstrated significant tumor regression in just three weeks of pre-surgical therapy, with five complete regressions observed in the Phase 3 study.

The selection criteria for the confirmatory study is supported by strong statistical significance (p=0.0015) in a large subgroup of 114 patients, and aligns with Multikine's biological mechanism of action.

CEL-SCI (NYSE: CVM) announced FDA agreement on using PD-L1 biomarker for patient selection in its upcoming Multikine Registration Study for head and neck cancer, starting Q1 2025. The study will focus on patients with low PD-L1 tumor expression, following promising results from a previous Phase 3 study where patients showed 73% vs. 45% five-year survival rate compared to control group. The new study will enroll approximately 212 patients with newly diagnosed locally advanced primary head and neck cancer without lymph node involvement. Multikine shows better effectiveness in patients with low PD-L1 expression, which represents about 70% of head and neck cancer cases.

CEL-SCI (NYSE American: CVM) announced potential positive implications for its immunotherapy Multikine® following a recent FDA Oncologic Drugs Advisory Committee (ODAC) meeting. The ODAC voted against the risk-benefit profile of PD-L1 inhibitors in various cancers for patients with low PD-L1 expression. This decision highlights a major treatment gap for low and negative PD-L1 cancer patients.

CEL-SCI's Multikine has shown survival benefit and favorable safety profile in a Phase 3 study of treatment-naïve resectable locally advanced head and neck cancer patients with low PD-L1 expression. The company believes Multikine is the only neoadjuvant immunotherapy demonstrating overall survival benefit in this population. CEL-SCI plans to use low PD-L1 expression as a selection criterion in its upcoming FDA confirmatory Registration Study.

CEL-SCI (NYSE American: CVM) has announced a renewed collaboration with Ergomed Clinical Research for its upcoming FDA confirmatory Registration Study of Multikine® in head and neck cancer. The study, set to enroll 212 newly diagnosed patients with locally advanced primary head and neck cancer, will focus on those with no lymph node involvement and low PD-L1 tumor expression. Ergomed will provide global comprehensive clinical operations support to ensure efficient trial execution.

This partnership builds on their previous successful collaboration in the largest Phase 3 trial ever conducted in head and neck cancer. CEL-SCI has also received pediatric waivers from the UK's MHRA and the EMA. The study is planned to commence in Q1 2025 across multiple countries. In prior studies, Multikine showed promising results, with a 5-year survival rate of 73% vs 45% in the control group for the target population.

CEL-SCI (NYSE American: CVM) reported new data from its Phase 3 study of Multikine® at the ESMO 2024 Congress. The data shows that Multikine increased the 5-year survival rate to 82.6% in locally advanced resectable head and neck cancer patients deemed low risk for recurrence, compared to 47.3% with standard care alone. The treatment also demonstrated a 73% reduction in overall risk of death (hazard ratio of 0.27).

These results are highly relevant to CEL-SCI's upcoming 212-patient confirmatory Registration Study, which has received FDA approval. The study will focus on patients with newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement and low PD-L1 tumor expression. The data suggests that better diagnostic technology, such as PET scans, could further optimize patient selection and improve Multikine's efficacy.