CEL-SCI Corporation Reports First Quarter Fiscal 2023 Financial Results

CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2022, as well as key clinical and corporate developments.

Clinical and Corporate Developments include:

• Multikine completely cleared cancer in 5 people with advanced head and neck cancer (locally advanced primary squamous cell carcinoma (SCC) of the head & neck (HN)) and 40 patients were partial responders whose tumors were reduced by more than 30% after 3 weeks of treatment with Multikine and prior to standard of care treatment.
  • Complete early tumor responses in 3 weeks have never before been reported in the scientific literature for locally advanced primary head and neck cancer according to medical experts and none were seen in the control group.
  • These data, from CEL-SCI’s Phase 3 head and neck cancer study, were presented by Dr. Philip Lavin in a video that was made public in October 2022. Dr. Lavin is a well-known biostatistician with a long history of supporting clinical trials for product registrations, reimbursements, and public health advancement. He has served on the faculty of Harvard Medical School at the Harvard School of Public Health for over 25 years and advised the U.S. Food and Drug Administration (FDA) from 1983 through 2015 on product approvals.
  • Images were presented in the video that clearly show tumors in patients’ oral cavity prior to treatment with Multikine and the disappearance of these tumors before any subsequent standard of care treatment, confirmed at surgery. The presentation and images can be seen here: LINK

• During the fiscal 2023 first quarter, CEL-SCI focused on assembling the vast body of clinical documentation of a Biologic License Application (BLA) required to obtain FDA approval for commercial marketing of Multikine. Data to be submitted from the Company’s Phase 3 global head and neck cancer of 928 patients include the following:
  • The Multikine-treated study population who received surgery and radiotherapy as their standard of care treatment showed significant advantages over the control group;
  • Nearly four years (46.5 months) median overall survival improvement;
  • 62.7% of Multikine patients were alive after five years vs. 48.6% in the control;
  • Complete tumor disappearance in five patients in just 3 weeks before surgery; and
  • Histopathology analysis showed evidence of Multikine’s mechanism of action at work.

• Data from the Company’s Phase 3 study have already been presented at the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) annual meetings in 2022. CEL-SCI continues to submit additional abstracts and manuscripts to peer-reviewed scientific journals and conferences for publishing and presentation. In fact, one of those submissions, which includes data CEL-SCI believes to be very important, is expected to be made public in the near future.

• The Company’s Multikine manufacturing facility is being prepared for inspection by the FDA in advance of Multikine’s commercial launch, pending FDA approval of a BLA.

• As of December 31, 2022, CEL-SCI had $18 million in cash and cash equivalents.

“We are hyper-focused on readying the vast body of data required to achieve a BLA approval from the FDA. Due to the unprecedented size, scope, length of study and nature of our Phase 3 study and the fact that Multikine is intended as a first-line treatment for primary, advanced head and neck cancer, the BLA submission has required tremendous time and effort, including expansion of the team to include independent medical and regulatory experts. We have shown a survival benefit for head and neck cancer patients with an immunotherapy given before surgery—this has never before been done. We are therefore starting from scratch. We remain highly energized and optimistic in our effort, because we believe Multikine can change the paradigm on cancer treatment and help a large number of patients. We look forward to providing updates as we reach milestones in the coming months,” stated CEL-SCI CEO, Geert Kersten.

Financial Results

The Company incurred a net operating loss of approximately $7.7 million for the three months ended December 31, 2022. This net operating loss consists of significant non-cash expenses including approximately $1.7 million in stock-based employee compensation, approximately $1.0 million in depreciation and amortization expense and approximately $0.2 million in other non-cash expenses. The net cash expenditures for the quarter were approximately $4.7 million.

During the three months ended December 31, 2022, research and development expenses decreased by approximately $0.7 million, or 11%, compared to the three months ended December 31, 2021. Major components of this decrease include approximately $0.9 million in employee stock compensation expense and $0.4 million in costs related to the Phase 3 clinical study. These decreases are offset by increases in costs incurred to prepare for the potential commercial sale of Multikine of approximately $0.4 million and other research and development costs of approximately $0.2 million.

During the three months ended December 31, 2022, general and administrative expenses decreased by approximately $0.5 million, or 18%, compared to the three months ended December 31, 2021.

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 studied patients who were newly diagnosed with locally 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 locally advanced primary head and neck cancer.

Multikine is designed to help the immune system “target” 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 test for 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.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

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 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, 2022. 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. 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.

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