VIENNA, Va., December 22, 2021--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2021, as well as key clinical and corporate developments.
Clinical and Corporate Developments included:
On October 22, 2021, CEL-SCI announced it completed the commercial scale expansion of its dedicated current Good Manufacturing Practice (cGMP) facility in which it manufactures its immunotherapy Multikine® (Leukocyte Interleukin, Injection)*. The construction, which began in 2020, was designed to ensure it will be compliant with all requirements of the U.S. Food and Drug Administration’s (FDA) and European cGMP regulations as the facility’s production capacity has been doubled to meet anticipated market demand for Multikine once it receives regulatory approval.
On June 28, 2021, CEL-SCI announced top line results from its 9.5 year global pivotal Phase 3 study for Multikine in head and neck cancer. The Phase 3 results showed a long-term 5-year overall survival (OS) benefit in the treatment arm receiving Multikine treatment regimen followed by surgery and radiation. This survival benefit was statistically significant (two-sided p=0.0236, HR=0.68), robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5-years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation): the Multikine treatment arm showed 62.7% overall survival versus the control arm which showed only 48.6% overall survival.
The OS benefit of 14.1% at 5 years for this treatment arm exceeded the 10% OS benefit set out for the study population in the protocol. The results from the Phase 3 cancer study proved that Multikine met all of protocol required benefits stated in the study protocol in patients in the treatment arm receiving surgery and radiation as their standard therapies.
Based on the results of this pivotal Phase 3 study, CEL-SCI intends to file a Biologic License Application with the FDA for approval of the Multikine treatment regimen in advanced primary squamous cell carcinoma of the head and neck patients scheduled to receive surgery and radiation as their primary treatments. CEL-SCI’s trial was conducted in over 20 countries in which marketing clearance applications may also be filed subsequent to FDA filing and/or approval.
CEL-SCI raised net proceeds of approximately $54.1 million during fiscal 2021 through the sale of common stock and the exercise of warrants and options. As of September 30, 2021, CEL-SCI had $42.2 million in cash, cash equivalents and U.S. Treasury Bills.
"Having conducted and completed the largest ever study in head and neck cancer, we are filing for regulatory approval with confidence that Multikine extends life in this severely unmet medical need. Our team has delivered and continues to work hard at preparing our BLA filing, validating and preparing our manufacturing facility for commercial production and publishing our data in peer reviewed journals. With a solid cash runway, we are optimistic about the future and the potential for Multikine to improve the lives of head and neck cancer patients and their families," stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported a net loss of $36.4 million in fiscal year 2021 versus a net loss of $30.3 million in fiscal year 2020. The increase in net loss was predominantly due to an increase in research and development expenses by approximately $5.3 million, or 30%, and an increase in general and administrative expenses by approximately $1.4 million, or 12%, compared to the year ended September 30, 2020. With the conclusion of the Phase 3 study, the expenditures for fiscal 2022 are expected to be lower.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine first, BEFORE they received surgery and radiotherapy or surgery plus concurrent radiotherapy and chemotherapy (the current standard of care for these patients). This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. 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. CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of advanced primary head and neck cancer.
Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. The Phase 3 study was started in early 2011 and was fully enrolled with 928 patients in September 2016. To prove an overall survival benefit, the study required CEL-SCI to wait until at least 298 (deaths) events had occurred among the two main comparator groups. This study milestone occurred in late April 2020 and database lock occurred in December 2020. The study results announced in June 2021 showed excellent survival benefit for those patients who received the Multikine treatment regimen plus surgery and radiation. When chemotherapy was added to the radiotherapy, the survival benefit was negated.
The Company’s LEAPS technology is being developed for rheumatoid arthritis. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
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 CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2021. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
STATEMENTS OF OPERATIONS
YEARS ENDED SEPTEMBER 30, 2021 and 2020
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Gavin de Windt