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Cel-Sci Corporation (symbol: CVM) is at the forefront of biotechnology, dedicated to advancing immunotherapy solutions for cancer and infectious diseases. Established in 1983 and headquartered in Vienna, Virginia, Cel-Sci is committed to harnessing the power of the human immune system to combat a variety of health challenges.
The company's leading investigational immunotherapy, Multikine (Leukocyte Interleukin, Injection), is currently in Phase III clinical trials for the treatment of head and neck cancer. This breakthrough therapy aims to improve survival rates by leveraging the body's natural defenses.
In addition to Multikine, Cel-Sci is pioneering the Ligand Epitope Antigen Presentation System (LEAPS), a pre-clinical patented T-cell modulation process designed to stimulate the immune system to fight bacterial, viral, and parasitic infections, and conditions such as autoimmune diseases, allergies, transplantation rejections, and cancer. Their innovative pipeline includes LEAPS-H1N1-DC, as well as product candidates CEL-2000 and CEL-4000 for the treatment of rheumatoid arthritis. The company is also developing LEAPS COV-19 to address the COVID-19 pandemic, in collaboration with the University of Georgia's Center for Vaccines and Immunology.
Cel-Sci's core capabilities extend to drug discovery, research, development, and the manufacturing of complex biological substances. The company's multifaceted approach not only targets cancer but also seeks to provide solutions for a wide range of infectious and autoimmune diseases. By focusing on these areas, Cel-Sci aims to deliver groundbreaking treatments that can significantly improve patient outcomes and quality of life.
Recent achievements and ongoing projects underscore Cel-Sci's commitment to innovation and excellence in the biotechnology field. The company's robust pipeline and strategic collaborations position it as a significant player in the quest for effective immunotherapies, offering hope to millions affected by cancer and other debilitating conditions.
Stay updated with the latest news and developments from Cel-Sci Corporation to track their progress and breakthroughs in cancer and immunotherapy research.
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.
CEL-SCI Corporation (NYSE American: CVM) announced it will discuss its Phase 3 head and neck cancer trial results post its Annual Shareholder Meeting on July 1, 2021. The trial showed a significant 14.1% 5-year survival benefit (62.7% vs 48.6%) for patients receiving surgery plus radiotherapy after treatment with Multikine®. The company plans to file for FDA approval in this patient group. Multikine is an investigational immunotherapy designed to enhance immune response against cancer, manufactured under strict GMP standards.
CEL-SCI Corporation (NYSE American: CVM) announced results from a pivotal 9.5-year Phase 3 study of its immunotherapy Multikine for advanced primary squamous cell carcinoma of the head and neck. The treatment demonstrated a statistically significant 14.1% overall survival benefit (OS) at 5 years (62.7%) for patients not receiving chemotherapy. The study enrolled 928 patients across 78 sites, showing no safety issues. Although the overall trial did not meet the primary endpoint, the results for the chemotherapy-free subgroup warrant an FDA approval request, highlighting an unmet medical need for around 155,000 patients annually.
CEL-SCI Corporation (NYSE American: CVM) is hosting its Annual Shareholder Meeting on July 1, 2021, at 10:00 a.m. EDT. Participants can submit questions until June 29, 2021, at 5:00 p.m. EDT via email. Due to COVID-19 concerns, the meeting will be hybrid, held both in-person and virtually. CEL-SCI is focused on cancer immunotherapy with its lead product, Multikine, in a pivotal Phase 3 trial for head and neck cancer, having received FDA Orphan Drug Status.
CEL-SCI Corporation (NYSE American: CVM) has successfully closed the offering of 1,400,000 shares of its common stock at a price of $22.62 per share, amounting to approximately $31.7 million in gross proceeds. The underwriter, Kingswood Capital Markets, has a 30-day option to purchase an additional 210,000 shares to cover over-allotments. This offering was made under a 'shelf' registration statement with the SEC. CEL-SCI is focused on developing immunotherapy treatments, with its lead therapy, Multikine, in a pivotal Phase 3 trial for head and neck cancer.
CEL-SCI Corporation (NYSE American: CVM) announced an increased public offering of 1,400,000 shares of common stock at $22.62 per share, a 5% discount to the last closing price. The offering, expected to close around June 11, 2021, will fund the development of Multikine and other corporate purposes. Kingswood Capital Markets is the sole book-runner. The offering is registered under an S-3 shelf registration. Investors are reminded that the offering is subject to market conditions and other risks.
CEL-SCI Corporation (NYSE American: CVM) announced an underwriting agreement with Kingswood Capital Markets to sell a minimum of 1,000,000 shares at $22.62 per share, a 5% discount from the June 8, 2021 closing price. The offering is set to close around June 11, 2021, subject to customary conditions. A 30-day option is granted to purchase an additional 15%. Proceeds will fund the development of Multikine and other corporate purposes. The shares are offered under a "shelf" registration statement with the SEC.
CEL-SCI Corporation (NYSE American: CVM) announced its financial results for Q2 2021, reporting an operating loss of $8.5 million, up from $6.7 million in Q2 2020. For the six months ended March 31, 2021, losses reached $17.3 million, compared to $13.6 million in the prior year. The company is in the statistical analysis phase of its Phase 3 head and neck cancer study of Multikine, with plans for a commercial launch following the completion of its $10.6 million manufacturing facility upgrade.
CEL-SCI Corporation (NYSE American: CVM) reported its financial results for the quarter ending December 31, 2020, highlighting key clinical developments.
Notably, the Phase 3 head and neck cancer study for Multikine is in statistical analysis, following data lock completion. The company also expanded its cGMP facility to double production capacity. Financially, CEL-SCI recorded a net loss of approximately $7.9 million, compared to $5.5 million for the same quarter in 2019. Cash reserves stood at approximately $21.9 million as of December 31, 2020, bolstered by a public offering that raised about $13.6 million.