CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2020, as well as key clinical and corporate developments.
Clinical and Corporate Developments included:
- During fiscal 2020, the Independent Data Monitoring Committee (IDMC) for the Company's pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Injection) conducted an official review of the study data in October 2019 and April 2020, and recommended in each case that the trial continue until the appropriate number of events has occurred. CEL-SCI announced in early May 2020 that the study reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation and the process of data lock commenced. In December 2020, the study entered its final stage of statistical analysis of all study data.
- In preparation for potential marketing clearance, CEL-SCI began expanding and upgrading its dedicated cGMP facility in which it manufactures Multikine. The construction will double the facility’s capacity, accommodating two shifts for increased production of Multikine.
- CEL-SCI initiated the development of an immunotherapy with the potential to treat COVID-19 using the Company’s patented LEAPS peptide technology and signed a collaboration agreement with the University of Georgia (UGA) Center for Vaccines and Immunology to develop its LEAPS COV-19 immunotherapy during fiscal 2020. Following the end of fiscal 2020, in December 2020, CEL-SCI announced that its LEAPS COV-19 peptides, delivered as a therapeutic treatment following SARS-CoV-2 virus challenge, achieved a 40% survival rate in human ACE2 transgenic mouse models as compared to 0% survival in the two control groups in studies conducted at UGA Center for Vaccines and Immunology.
- The LEAPS platform technology was issued a patent from the European Patent Office titled “Method of Preparation and Composition of Peptide Constructs for Treatment of Rheumatoid Arthritis”. In addition to the treatment of COVID-19, the LEAPS platform technology is being developed as a potential therapeutic vaccine for rheumatoid arthritis supported by grants from the U.S. National Institutes of Health (NIH).
- CEL-SCI raised net proceeds of approximately $25.8 million during fiscal 2020 through the sale of common stock and the exercise of warrants and options. In December 2020, following the end of the 2020 fiscal year, CEL-SCI raised an additional $14.7 million.
“The aim of our Phase 3 pivotal study is to show that our immunotherapy Multikine can help head and neck cancer patients when administered right after diagnosis, before surgery, radio and chemotherapy have weakened the immune system. After a decade of running the world’s largest Phase 3 study in head and neck cancer, we are looking forward to hearing the final study results which will hopefully prove our concept. We are grateful to all the stakeholders who have patiently been on this long journey with us,” stated CEL-SCI CEO, Geert Kersten.
“While Multikine in the treatment of head and neck cancer is our immediate focus and opportunity, based on Phase 3 results, we may evaluate Multikine for the treatment of other cancers, concurrent with advancing our LEAPS therapeutic vaccine platform in COVID-19 and rheumatoid arthritis,” Kersten concluded.
CEL-SCI reported a net loss of $30.3 million in fiscal year 2020 versus a net loss of $22.1 million in fiscal year 2019. The increase in net loss was predominantly due to an increase in research and development expenses by approximately $5.2 million, or 41%, and an increase in general and administrative expenses by approximately $3.7 million, or 46%, compared to the year ended September 30, 2019.
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, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for the 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 head and neck cancer. Per the study’s protocol, newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck were treated with the Multikine treatment regimen right after diagnosis and prior to receiving the Standard of Care (SOC), which involves surgery, radiation or concurrent radiochemotherapy. 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 better be able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body’s immune system prior to SOC to attack the cancer. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups. This study milestone occurred in late April 2020. The study is currently in the statistical analysis phase.
The Company’s LEAPS technology is being developed for rheumatoid arthritis and as a potential treatment for COVID-19 infection. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
The Company’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the Company’s ability to continue as a going concern.
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, 2020. 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.
STATEMENTS OF OPERATIONS
YEARS ENDED SEPTEMBER 30, 2020 and 2019
Research and development
General and administrative
Total operating expenses
Loss on derivative instruments
Warrant inducement expense
Other non-operating gain
Interest expense, net
Modification of warrants
Net loss available to common shareholders
Net loss per common share, basic and diluted
Weighted average common shares outstanding, basic and diluted