CEL-SCI Corporation Reports Second Quarter Fiscal 2022 Financial Results

By: CEL-SCI Corporation via Business Wire

May 16, 2022 at 08:50 AM EDT

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

Clinical and Corporate Developments include:

The American Society of Clinical Oncology (ASCO) has accepted two abstracts related to CEL-SCI’s pivotal Phase 3 Multikine® (Leukocyte Interleukin, Injection)* head and neck cancer clinical trial for presentation at the 2022 ASCO Annual Meeting to be held June 3-7, 2022 in Chicago, Illinois. The abstract titles are:
- “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.”
- “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.”

Head and neck cancer patients who are scheduled to receive surgery and radiation as their first treatments have not seen a marked improvement in their treatment outcome in decades. CEL-SCI’s Phase 3 study showed great improvement in survival with no toxicity issues for these patients with a statistically significant, robust, and durable survival benefit of 14.1% at 5 years. This is clearly an unmet medical need for an estimated 211,000 people globally.

Additional results from the Phase 3 study of Multikine in advanced primary head and neck cancer have been submitted to the U.S. government clinical trial website www.clinicaltrials.gov. That data is expected to be released to the public in the near future.

CEL-SCI’s dedicated current Good Manufacturing Practice (cGMP) facility in which it manufactures Multikine is now undergoing validation following the completion of its commercial scale build out during the first quarter of 2022. The construction is designed to ensure the facility will be compliant with all U.S. Food and Drug Administration’s (FDA) and European cGMP regulations.

As of March 31, 2022, CEL-SCI had $34.3 million in cash and cash equivalents.

“ASCO’s annual meeting in June, with over 40,000 oncology professionals from over 100 countries expected, is one of the largest and most prominent oncology conferences. Our scientific team looks forward to presenting two abstracts there, and we expect a high level of interest based on Multikine’s results and the fact that outcomes have not improved for the head and neck cancer population in decades,” stated CEL-SCI CEO, Geert Kersten. “The conference is well timed to inform oncologists from around the world about Multikine ahead of our planned regulatory filing for approval.”

CEL-SCI reported an operating loss of $18.4 million for the six months ended March 31, 2022 versus an operating loss of $17.3 million for the six months ended March 31, 2021. CEL-SCI reported an operating loss of $9.6 million for the three months ended March 31, 2022 versus an operating loss of $8.5 million for the three months ended March 31, 2021. Net cash used in operating activities was $7.5 million for the six months ended March 31, 2022 which represents a decrease of $1.2 million compared to the six months ended March 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 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.

The Company’s LEAPS technology is being developed for rheumatoid arthritis. 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, 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.

CEL-SCI CORPORATION CONDENSED STATEMENTS OF OPERATIONS SIX MONTHS ENDED MARCH 31, 2022 AND 2021 (UNAUDITED)

	2022	2021

Operating expenses:
Research and development	$ 12,606,984	$ 10,636,274
General and administrative	5,788,250	6,627,640
Total operating expenses	18,395,234	17,263,914

Operating loss	(18,395,234)	(17,263,914)

Gain (loss) on derivative instruments	366,791	(2,108,181)
Other non-operating (loss) gain	(30,793)	675,236
Interest expense, net	(546,862)	(521,125)

Net loss	(18,606,098)	(19,217,984)
Modification of warrants	-	(85,779)

Net loss available to common shareholders	$ (18,606,098)	$ (19,303,763)


Net loss per common share - basic and diluted	$ (0.43)	$ (0.49)

Weighted average common shares outstanding - basic and diluted	43,100,070	39,351,194

CEL-SCI CORPORATION CONDENSED STATEMENTS OF OPERATIONS THREE MONTHS ENDED MARCH 31, 2022 AND 2021 (UNAUDITED)

	2022	2021

Operating Expenses:
Research and development	$ 6,523,817	$ 5,221,514
General and administrative	3,028,042	3,311,484
Total operating expenses	9,551,859	8,532,998

Operating loss	(9,551,859)	(8,532,998)

Gain (loss) on derivative instruments	2,195	(3,041,017)
Other non-operating gain	-	553,630
Interest expense, net	(273,828)	(260,735)

Net loss	$ (9,823,492)	$ (11,281,120)



Net loss per common share - basic and diluted	$ (0.23)	$ (0.28)

Weighted average common shares outstanding - basic and diluted	43,122,671	40,047,273

View source version on businesswire.com: https://www.businesswire.com/news/home/20220516005179/en/

Contacts

COMPANY CONTACT:

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

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CEL-SCI Corporation Reports Second Quarter Fiscal 2022 Financial Results

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