CEL-SCI Reports Fiscal 2022 Financial Results and Clinical & Corporate Developments

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2022, as well as key clinical and corporate developments.

Clinical and Corporate Developments:

CEL-SCI’s main focus throughout fiscal year 2022 has been to complete and submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of Multikine®* (Leukocyte Interleukin, Injection) in the treatment of advanced primary head and neck cancer.

Current drug therapies for squamous cell carcinoma of the head and neck (SCCHN) from Merck and Bristol Myers Squibb (BMS) are approved as a last resort for recurrent tumors after treatments have failed or for patients who are not candidates for surgery. By contrast, Multikine is given to newly-diagnosed patients following initial diagnosis and ahead of surgery— it’s the first of its kind with substantial survival benefit in a randomized Phase 3 trial in locally advanced primary SCCHN.

• The Multikine treated study population who receive surgery and radiotherapy as their standard of care treatments showed the following advantages over control:
  • A median overall survival improvement of 46.5 months— nearly four years.
  • 62.7% of Multikine patients were alive after five years vs. 48.6% in the control.
  • Nearly one out of every six patients had their tumors shrink by more than 30% in just 3 weeks and prior to surgery.
  • Five patients had their tumors completely disappear in just 3 weeks and prior to surgery.
  • Tumor shrinkage/disappearance cut the death rate by a factor of three.

• CEL-SCI published and presented data from its pivotal randomized controlled Phase 3 Multikine head and neck cancer clinical trial at two prestigious cancer conferences.
  • 2022 ASCO Annual Meeting in Chicago, Illinois
    • “Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and neck (SCCHN): Using pretreatment data only.” – Abstract
    • “Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study.” – Abstract and Poster Presentation
  • European Society for Medical Oncology (ESMO) annual Congress in Paris, France
    • Early response to Neoadjuvant Leukocyte Interleukin Injection (LI) immunotherapy extends overall survival (OS) in locally advanced primary squamous cell carcinoma (SCC) of the head & neck (HN): the IT-MATTERS Study – Poster Presentation and Video Presentation
    • Histopathology (HP) biomarkers confirm Leukocyte Interleukin Injection (LI) treatment (Tx) outcome in naïve locally advanced primary head & neck squamous cell carcinoma (SCCHN) the IT-MATTERS Study – Poster Presentation

• Additional results from the Phase 3 clinical trial of Multikine in advanced primary head and neck cancer were posted to the U.S. government clinical trial website www.clinicaltrials.gov.

• CEL-SCI has submitted additional abstracts/manuscripts to be published/presented.

• CEL-SCI’s dedicated manufacturing facility in which it manufactures Multikine is being validated following the completion of its commercial scale build out during the first quarter of 2022. The construction was designed to ensure the facility will be compliant with all FDA GMP and European regulations.

• As of September 30, 2022, CEL-SCI had $22.7 million in cash and cash equivalents.

“We are the first to have achieved successful neoadjuvant (before surgery) immunotherapy in head and neck cancer. Keytruda and Opdivo, the two most successful cancer drugs today, have not shown a survival benefit as a neoadjuvant for advanced primary head and neck cancer, and the last FDA approval for this disease was decades ago. We have shown a very large improvement in survival for the patients scheduled to receive surgery and radiotherapy as their standard of care treatments. We have presented at top cancer conferences. We are very proud of this success, but I would like to increase the speed of our progress towards submitting a BLA and gaining marketing approval in the U.S. as well as in Canada. A number of factors are responsible for the rate at which we have been progressing. First, we have succeeded at something that has never been done successfully before—show improvement in survival from a neoadjuvant for advanced primary head and neck cancer patients. Second, the study that supports this achievement was long, enrolled a large number (928) of patients, and produced an extensive amount of data that had to be analyzed and interpreted. Third, because we are not a big pharma company with virtually unlimited staff and resources, we have not been able to complete our milestones as quickly as bigger companies would have done. But, as has always been the case with CEL-SCI, our tenacity gets the job done and done well. The Phase 3 study results bear this out. I am looking forward to a lot of positive activity and progress next year as we continue in our efforts to bring Multikine to market for patients with a severe unmet medical need,” stated CEL-SCI CEO, Geert Kersten.

Financial Results

CEL-SCI incurred a net operating loss of approximately $36.1 million for the twelve months ended September 30, 2022, of which approximately $11.4 million was non-cash expense including stock-based employee compensation and approximately $3.8 million in depreciation and amortization expense while cash spent was $18.2 million. The cash balance on September 30, 2022 was $22.7 million.

During the year ended September 30, 2022, research and development expenses increased by approximately $2.2 million, or 10%, and general and administrative expenses decreased by approximately $2.4 million, or 18%, compared to the year ended September 30, 2021.

CEL-SCI’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to CEL-SCI’s ability to continue as a going concern.

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.

CEL-SCI CORPORATION STATEMENTS OF OPERATIONS YEARS ENDED SEPTEMBER 30, 2022 and 2021
	2022		2021
Operating expenses:
Research and development	$	25,355,346	$	23,108,897
General & administrative		10,707,447		13,085,232
Total operating expenses		36,062,793		36,194,129
Operating loss		(36,062,793)		(36,194,129)
Other income (expense)		107,148		(8,213)
Gain (loss) on derivative instruments		366,791		(694,858)
Other non-operating (loss) gain		(30,793)		1,685,379
Interest expense, net		(1,081,034)		(1,149,288)
Net loss	$	(36,700,681)	$	(36,361,109)
Modification of warrants		(929,122)		(350,861)
Net loss available to common shareholders	$	(37,629,803)	$	(36,711,970)
Net loss per common share - basic	$	(0.87)	$	(0.90)
Weighted average common shares outstanding - basic		43,148,888		40,662,137
Net loss per common share - diluted	$	(0.87)	$	(0.93)
Weighted average common shares outstanding - diluted		43,148,888		40,694,248