CEL-SCI Corporation Reports First Quarter Fiscal 2024 Financial Results
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. InOctober 2023 , the new data were presented at the 2023European Society for Medical Oncology (ESMO) 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’sNational 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 theUK .
-
The European Medicines Agency’s (EMA) Paediatric Committee granted
CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in theEuropean Union (EU). The waiver is a big step forward for Multikine, as it removes a major hurdle on the path towards commercialization inEurope .
-
CEL-SCI plans to submit the target population data to theU.S. Food and Drug Administration (FDA) this quarter.Health Canada advisedCEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions (NOCC) policy. Meetings with theUK 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
Financial Results
The Company incurred a net operating loss of approximately
During the three months ended
About
After analyzing data from the Phase 3 study, we have better defined the target population, which is advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival data in the final target population, showing that Multikine cut the risk of death in half at five years vs control. We plan to submit the proposed study protocol to the FDA in Q1 2024, with the goal to get FDA buy-in for a confirmatory clinical trial, and also to discuss potential accelerated approval pathways.
Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
The Company has operations in
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in
* Multikine (Leukocyte Interleukin, Injection) is the trademark that
CONDENSED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED (UNAUDITED) |
|||||||
2023 |
|
2022 |
|||||
Operating expenses: |
|||||||
Research and development |
$ |
4,352,509 |
|
$ |
5,392,546 |
|
|
General and administrative |
|
2,133,378 |
|
|
2,258,003 |
|
|
Total operating expenses |
|
6,485,887 |
|
|
7,650,549 |
|
|
|
|
||||||
Operating loss |
|
(6,485,887 |
) |
|
(7,650,549 |
) |
|
Interest expense, net |
|
(197,696 |
) |
|
(152,789 |
) |
|
Other expense |
|
(25,941 |
) |
|
|
(50,171 |
) |
|
|
||||||
Net loss |
|
(6,709,524 |
) |
|
(7,853,509 |
) |
|
Modification of warrants |
|
- |
|
|
(171,552 |
) |
|
|
|
||||||
Net loss available to common shareholders |
$ |
(6,709,524 |
) |
$ |
(8,025,061 |
) |
|
Net loss per common share – basic and diluted |
$ |
(0.14 |
) |
$ |
(0.18 |
) |
|
Weighted average common shares outstanding – basic and diluted |
|
48,470,600 |
|
|
43,440,387 |
|
|
|
|||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240215017088/en/
(703) 506-9460
Source: