VIENNA, Va. - CEL-SCI Corporation (NYSE American: CVM) today revealed new data from its completed Phase 3 study of Multikine, indicating a substantial increase in the 5-year survival rate for a specific patient group with head and neck cancer. The findings were presented at the European Society for Medical Oncology (ESMO) 2024 Congress over the weekend.
The data focuses on patients with newly diagnosed, locally advanced primary head and neck cancer who are at low risk for recurrence post-surgery and, according to National Comprehensive Cancer Network (NCCN) guidelines, would not typically receive chemotherapy after surgery. In this subgroup, patients treated with Multikine before surgery saw a 5-year survival rate of 82.6%, compared to 47.3% for those who received the standard of care alone.
CEL-SCI's analysis of the Phase 3 study, which involved 923 patients, showed that those at low risk for recurrence had a median overall survival benefit of nearly four years over the control group. The upcoming confirmatory Registration Study, greenlit by the FDA, will target this patient population, which showed the most significant benefit.
The company's CEO, Geert Kersten, commented on the potential of improved diagnostic techniques, such as PET scans, to further enhance patient selection and, by extension, survival outcomes. The confirmatory study will utilize PET scans to refine patient selection criteria.
The presented data also highlighted a 73% reduction in the overall risk of death for the low-risk patient group treated with Multikine, with a hazard ratio of 0.27. CEL-SCI's Chief Scientific Officer, Dr. Eyal Talor, emphasized that the selection criteria developed for the upcoming study have already demonstrated an overall survival advantage.
CEL-SCI Corporation is focused on innovative therapies that boost the immune system to fight cancer. Multikine is designed to be administered before surgery to help the immune system target the tumor more effectively. The company is preparing for the confirmatory Registration Study, which is expected to enroll 212 patients.
These findings are based on a press release statement and have not been independently verified. Multikine has not been approved by the FDA or any other regulatory agency. The safety and efficacy of the treatment have yet to be established for any use.
In other recent news, CEL-SCI Corporation has made significant strides in the development of its investigational cancer treatment, Multikine. The UK's Healthcare Products Regulatory Agency granted a pediatric study waiver for Multikine, eliminating the need for trials in patients under 18 as part of the UK marketing approval process. Additionally, the FDA has agreed to the company's patient selection criteria for a forthcoming Registration Study, which will enroll 212 patients.
In terms of funding, CEL-SCI announced a public offering of 10,845,000 shares, priced at $1.00 each, with projected gross proceeds of $10.8 million. These funds are earmarked for the development of Multikine and general corporate needs. ThinkEquity is the sole placement agent for the transaction.
Moreover, the company reported encouraging outcomes from a comprehensive bias analysis for its Phase 3 study of Multikine. This analysis found no significant differences between the treatment and control groups, supporting Multikine's clinical effect in extending patient survival.
It's important to note these are recent developments and that Multikine is still under investigation. Its safety and efficacy have not yet been established for any use. Despite these advancements, CEL-SCI Corporation cautions that it cannot guarantee the ability to replicate clinical results or obtain necessary regulatory approvals.
InvestingPro Insights
In light of CEL-SCI Corporation's promising clinical trial results, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, CEL-SCI's gross profit for the last twelve months as of Q3 2024 stands at a negative $18.95 million. This figure aligns with one of the InvestingPro Tips highlighting the company's weak gross profit margins. Moreover, the data reveals an operating loss of $27.7 million and an EBITDA of negative $25.52 million for the same period, underscoring the financial challenges the company faces.
Despite these financial metrics, CEL-SCI's stock has experienced a significant return over the last week, with a 20.75% increase in price total return, and a strong return over the last month at 13.27%. This positive market response could be reflective of investor optimism following the recent clinical trial news. However, it's important to note that the company's net income is expected to drop this year, and analysts do not anticipate profitability for the year, as suggested by additional InvestingPro Tips.
For investors seeking to delve deeper into CEL-SCI's financials and stock performance, there are additional InvestingPro Tips available, including insights into the company's debt levels and liquidity concerns. Specifically, the tip regarding short-term obligations exceeding liquid assets may be of interest to those evaluating the company's immediate financial stability. In total, there are 9 additional InvestingPro Tips accessible to provide a comprehensive analysis of CEL-SCI, which can be found at https://www.investing.com/pro/CVM.
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