Cel-Sci Corporation - CVM STOCK NEWS

CEL-SCI (NYSE American: CVM) reported its Q3 fiscal 2024 financial results and key developments. Highlights include:

1. Positive bias analysis results for Multikine, supporting its role in increasing patient survival.

2. FDA approval for a confirmatory Registration Study of Multikine in head and neck cancer treatment.

3. Presentation at IDDST Congress showcasing Multikine's efficacy in patients with low tumor PD-L1 expression.

4. Board strengthening with new appointments.

5. R&D expenses decreased to $4.7 million from $5.7 million year-over-year.

6. G&A expenses reduced to $2.0 million from $2.5 million year-over-year.

7. Post-quarter equity fundraise of $10.85 million completed on July 29, 2024.

CEL-SCI (NYSE American: CVM), a cancer immunotherapy company, has closed a $10.8 million offering of 10,845,000 shares of common stock (or pre-funded warrants) at $1.00 per share. The company plans to use the net proceeds to fund the development of Multikine, its lead investigational therapy, as well as for general corporate purposes and working capital. ThinkEquity acted as the sole placement agent for this best-efforts offering. CEL-SCI is preparing to commence a confirmatory trial for Multikine, with enrollment expected to begin in Q4 2024. The company's focus remains on activating the immune system to fight cancer and infectious diseases.

CEL-SCI (NYSE American: CVM), a cancer immunotherapy company, has announced the pricing of a $10.8 million offering of 10,845,000 shares of common stock (or pre-funded warrants) at $1.00 per share. The offering, expected to close on July 29, 2024, aims to fund the development of Multikine, their lead investigational therapy, and general corporate purposes. ThinkEquity is acting as the sole placement agent for this best-efforts offering. CEL-SCI's Multikine has completed a pivotal Phase 3 clinical trial for head and neck cancer and received Orphan Drug Status from the FDA. The company plans to commence a confirmatory trial for Multikine, with enrollment expected to begin in Q4 2024.

CEL-SCI (NYSE American: CVM) reported positive results from a bias analysis for its Phase 3 study of Multikine in head and neck cancer treatment. The analysis showed no bias in the study, with comparable demographics and baseline characteristics between Multikine-treated and control arms. This supports the reliability of the study data, which demonstrated Multikine's efficacy in extending patient life.

Key findings include:

• 5-year survival rate of 73% in Multikine-treated patients vs. 45% in control group for the target population
• Hazard ratio of 0.35 with an upper limit of 0.66, suggesting a high chance of repeating the survival benefit
• No confounding baseline parameters detected

CEL-SCI is preparing to submit data to regulators for a 212-patient confirmatory registration study, agreed upon with the FDA.

CEL-SCI (NYSE American: CVM) has appointed Robert Watson as Chairperson of the Board. Watson, who joined the board in 2017, has an extensive background in the healthcare sector, particularly in capital formation and partnerships. He has facilitated over $750 million in transactions throughout his career.

Watson's appointment comes at a pivotal moment for CEL-SCI, as the company prepares for a confirmatory Registration Study for its immunotherapy drug, Multikine. The FDA approved this study based on positive efficacy and safety data from over 750 patients. Multikine showed a 73% survival rate compared to 45% in the control group at five years post-treatment.

The forthcoming study will enroll 212 patients with advanced primary head and neck cancer, a condition impacting an estimated 100,000 patients annually. Watson expressed confidence in confirming the drug’s efficacy and safety, emphasizing his commitment to CEL-SCI’s mission.

CEL-SCI announced promising data for its investigational drug Multikine at the IDDST Annual Congress in Budapest. Dr. Eyal Talor presented findings showing that Multikine significantly improves overall survival in head and neck cancer patients with low PD-L1 expression levels. Specifically, the 5-year survival rate for Multikine-treated patients was 73%, compared to 45% in the control group. The hazard ratio was 0.35, indicating a 5-year death risk reduction from 55% to 27%. The company is planning a confirmatory FDA registration study.

CEL-SCI announced that Dr. Giovanni Selvaggi, a renowned oncology expert, has joined as a Clinical Advisor. Dr. Selvaggi has been pivotal in the approval of lung cancer drugs such as Zykadia and Opdivo. CEL-SCI's Multikine immunotherapy has shown significant efficacy in head and neck cancer, improving 5-year survival to 73% compared to 45% in controls. The FDA has approved a confirmatory Registration Study for Multikine. Dr. Selvaggi will support CEL-SCI in navigating this trial, aiming for regulatory approval.

CEL-SCI (NYSE American: CVM) reported its Q2 fiscal 2024 financial results. Key clinical and corporate developments included FDA approval for a confirmatory Registration Study of Multikine in head and neck cancer, following strong Phase 3 results with a 28% survival benefit at 5 years. The new study will enroll 212 patients.

Financial highlights for the period ending March 31, 2024: R&D expenses decreased by $2.5M to $9M, G&A expenses increased slightly to $4.6M, and net loss narrowed by $2.2M to $14M. CEL-SCI also raised $7.75M through a public stock offering. Other notable developments: completion of a state-of-the-art manufacturing facility and a key waiver from the European Medicines Agency for Multikine's commercialization in Europe.

CEL-SCI has received FDA approval for a confirmatory study of its cancer immunotherapy Multikine for head and neck cancer patients, based on strong Phase 3 data showing a 73% survival rate with Multikine. The study will enroll 212 patients and aims to confirm the results of the Phase 3 trial, paving the way for potential approval. The FDA acknowledged the unmet need for improved therapies in this patient population, supporting approval for Multikine.