On February 15, 2024 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments (Press release, Cel-Sci, FEB 15, 2024, View Source [SID1234640171]).
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Clinical and Corporate Developments include:
CEL-SCI identified the target head and neck cancer patient population for Multikine (Leukocyte Interleukin, Injection)* that will be the basis for the Company’s regulatory filings for marketing clearance. In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The target population, which saw its 5-year risk of death cut in half, can be identified prior to surgery upon diagnosis with tests that physicians routinely use in cancer screenings, a key finding for Multikine, which is a neoadjuvant therapy. A summary of Multikine’s results in the target population include the following:
73% survival for Multikine vs 45% in the control at 5 years
28% absolute survival benefit
Statistically significant p = 0.0015 and hazard ratio = 0.35
Tumor reduction rate >13% and tumor downstaging >35%
No safety signals or toxicities vs standard of care
Target population of an estimated 145,000 patients (global, annual) with newly diagnosed squamous cell carcinoma of the head and neck (SCCHN) who present with:
No lymph node involvement (via PET scan)
Low PD-L1 tumor expression (TPS<10) (via biopsy).
Physicians routinely assess these features at baseline; no extra tests needed. These features make it easy to write a label for Multikine, which is essential for drug approval
CEL-SCI estimates that low PD-L1 patients represent about 70% of locally advanced primary SCCHN patients
CEL-SCI issued a comprehensive Letter to Shareholders detailing the data reported on the efficacy of Multikine in the head and neck cancer target patient population
CEL-SCI’s cGMP state-of-the-art dedicated manufacturing facility commissioning was completed, a significant milestone toward a planned Biologics License Application (BLA) with several regulatory agencies for approval of Multikine. The Company’s manufacturing trade secrets, capabilities, and know-how are high-value key strategic assets that are very difficult for others to replicate.
The United Kingdom’s (UK) National Institute for Health and Care Excellence (NICE) selected Multikine to be evaluated as the potential new standard of care for SCCHN. NICE posted a detailed report from the UK’s National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK.
The European Medicines Agency’s (EMA) Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union (EU). The waiver is a big step forward for Multikine, as it removes a major hurdle on the path towards commercialization in Europe.
CEL-SCI plans to submit the target population data to the U.S. Food and Drug Administration (FDA) this quarter. Health Canada advised CEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions (NOCC) policy. Meetings with the UK regulators and the EMA are expected H1 2024.
"Following the identification of our focused patient population, backed by robust efficacy data, we have made progress with global regulators, including in the UK and EU where we expect meetings in the coming months. Our manufacturing facility is fully commissioned and should soon be ready for commercial-scale production," stated CEL-SCI CEO, Geert Kersten. "We are optimistic about working with regulators to get Multikine to the patients who need it. Statistically significant data demonstrate our target patient population can benefit from a longer life with Multikine."
Financial Results
The Company incurred a net operating loss of approximately $6.5 million for the three months ended December 31, 2023, approximately $2.6 million of which was non-cash expenses.
During the three months ended December 31, 2023, research and development expenses decreased by approximately $1.0 million, or 19%, compared to the three months ended December 31, 2022. During the three months ended December 31, 2023, general and administrative expenses decreased by approximately $0.1 million, or 6%, compared to the three months ended December 31, 2022.
CEL-SCI raised $5 million in November 2023 and $7.75 million in February 2024, both through public offerings of common stock.