CEL-SCI Corporation Reports Second Quarter Fiscal 2021 Financial Results

Rhea-AI Summary

CEL-SCI Corporation (NYSE American: CVM) announced its financial results for Q2 2021, reporting an operating loss of $8.5 million, up from $6.7 million in Q2 2020. For the six months ended March 31, 2021, losses reached $17.3 million, compared to $13.6 million in the prior year. The company is in the statistical analysis phase of its Phase 3 head and neck cancer study of Multikine, with plans for a commercial launch following the completion of its $10.6 million manufacturing facility upgrade.

Positive

• Completion of Phase 3 study database lock for head and neck cancer.
• Expansion of cGMP manufacturing facility to double capacity.
• Independent contractors conducting statistical analysis for FDA requirements.

Negative

• Operating loss increased to $8.5 million for the quarter.
• Phase 3 study took longer to reach required patient events.
• Total operating loss of $17.3 million for the six months.

CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended March 31, 2021, as well as key clinical and corporate developments.

Clinical and Corporate Developments include:

• In December 2020, CEL-SCI stated that its pivotal Phase 3 head and neck cancer study completed database lock and entered the statistical analysis phase. CEL-SCI remains blinded to the study data and is not involved in the analysis process which is conducted by independent contractors. The statistical analysis plan follows the protocol stated objectives and is designed to meet FDA requirements to define safety and efficacy, those clinical benefits that Multikine might provide for patients newly diagnosed with advanced primary (not yet treated) squamous cell carcinoma of the head and neck.

• In preparation for the anticipated commercial launch of Multikine, CEL-SCI has been expanding and upgrading its dedicated cGMP manufacturing facility for Multikine. The construction, which began in 2020, is expected to be completed soon and will double the facility’s capacity to accommodate two shifts for increased production of Multikine.

“We believed in cancer immunotherapy when few did. We were the first to administer an immunotherapy drug right after diagnosis, ahead of surgery, radiation and chemotherapy, because we believe that the activation of an anti-tumor response by the immune system is best achieved before standard therapies damage it. We believe that it is possible to develop a non-toxic cancer drug. Our Phase 3 study took years longer than expected because it took longer than expected to reach the required number of events (patient deaths) in the comparator arms of the study. It is all about the final data,” stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported an operating loss of $17.3 million for the six months ended March 31, 2021 versus an operating loss of $13.6 million for the six months ended March 31, 2020. CEL-SCI reported an operating loss of $8.5 million for the quarter ended March 31, 2021 versus an operating loss of $6.7 million for the quarter ended March 31, 2020.

During the six and three months ended March 31, 2021, CEL-SCI incurred approximately $6.9 million and $3.3 million, respectively, in capitalized costs to upgrade its manufacturing facility to prepare for the potential commercial production of Multikine. Total estimated costs of this upgrade are approximately $10.6 million, of which approximately $9.5 million has been incurred through March 31, 2021. The landlord of the property has agreed to finance the final $2.4 million of costs and allow for the repayment through increased lease payments beginning March 1, 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, are treated with the investigational product Multikine first, BEFORE they received surgery, radiation or chemoradiotherapy (the current standard of care [SOC] 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), 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 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 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 completed enrollment with 928 patients in September 2016. To prove an overall survival benefit, the study required CEL-SCI to wait until 298 (death) 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.

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, 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.

CEL-SCI CORPORATION CONDENSED STATEMENTS OF OPERATIONS SIX MONTHS ENDED MARCH 31, 2021 AND 2020 (UNAUDITED)
	2021			2020
Grant income	$	-		$	334,232
Operating Expenses:
Research and development		10,636,274			8,711,360
General and administrative		6,627,640			5,197,418
Total operating expenses		17,263,914			13,908,778
Operating loss		(17,263,914)			(13,574,546)
Other income		-			36,896
Loss on derivative instruments		(2,108,181)			(2,282,518)
Other non-operating gains		675,236			1,725,180
Interest expense, net		(521,125)			(504,190)
Net loss		(19,217,984)			(14,599,178)
Modification of warrants		(85,779)			(21,734)
Net loss available to common shareholders	$	(19,303,763)		$	(14,620,912)
Net loss per common share - basic and diluted	$	(0.49)		$	(0.41)
Weighted average common shares outstanding - basic and diluted		39,351,194			35,621,711

CEL-SCI CORPORATION CONDENSED STATEMENTS OF OPERATIONS THREE MONTHS ENDED MARCH 31, 2021 AND 2020 (UNAUDITED)
	2021			2020
Grant income	$	-		$	298,726
Operating Expenses:
Research and development		5,221,514			4,458,547
General and administrative		3,311,484			2,558,522
Total operating expenses		8,532,998			7,017,069
Operating loss		(8,532,998)			(6,718,343)
Other income		-			18,448
Loss on derivative instruments		(3,041,017)			(3,049,027)
Other non-operating gains		553,630			934,511
Interest expense, net		(260,735)			(253,407)
Net loss		(11,281,120)			(9,067,818)
Modification of warrants		-			(21,734)
Net loss available to common shareholders	$	(11,281,120)		$	(9,089,552)
Net loss per common share - basic and diluted	$	(0.28)		$	(0.25)
Weighted average common shares outstanding - basic and diluted		40,047,273			36,165,050

 

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FAQ

What were CEL-SCI's financial results for the quarter ended March 31, 2021?

CEL-SCI reported an operating loss of $8.5 million for Q2 2021, compared to $6.7 million for Q2 2020.

What are the key developments from CEL-SCI's recent press release?

Key developments include the completion of the Phase 3 study database lock for Multikine and upgrades to its manufacturing facility.

What is the current status of CEL-SCI's Phase 3 cancer study?

The study has completed database lock and is now in the statistical analysis phase, conducted by independent contractors.

How much is CEL-SCI investing in its manufacturing facility upgrade?

CEL-SCI has incurred approximately $9.5 million of the estimated $10.6 million for the facility upgrade as of March 31, 2021.