CVM Cel Sci Corporation New

CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2021, as well as key clinical and corporate developments.

Clinical and Corporate Developments include:

• On June 28, 2021, CEL-SCI announced top line results from its 9.5 year global pivotal Phase 3 study for its immunotherapy Multikine® (Leukocyte Interleukin, Injection)* in head and neck cancer. The Phase 3 results showed a long-term 5-year overall survival (OS) benefit in the treatment arm receiving Multikine treatment regimen followed by surgery and radiation. This survival benefit was statistically significant, robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5-years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation): Multikine arm 62.7%, control arm 48.6% survival.

• The OS benefit of 14.1% at 5 years for this treatment arm exceeded the >10% OS benefit set out for the study population as a whole in the protocol. The OS results for this treatment arm were significant (two-sided p=0.0236, HR=0.68) and the survival effect increased over time. The results from the Phase 3 cancer study proved that Multikine met all of the protocol required benefits stated in the study protocol in patients in the treatment arm receiving surgery and radiation as their standard therapies. Based on the results of this pivotal Phase 3 study, CEL-SCI intends to file a Biologic License Application with U.S. Food and Drug Administration (FDA) for approval of this indication. We are assembling the information required to request a pre-BLA (Biologics License Application) meeting with the FDA to discuss the adequacy of the study results to support a license application and receive FDA input on any other issues that would have to be addressed for an approval to be granted.

• Worldwide there are approximately 890,000 newly diagnosed head and neck cancer patients of which CEL-SCI’s target population when filing for FDA approval is about 210,000 patients. That would mean that approximately 29,000 patients could be alive at 5-years if all 210,000 eligible patients received the Multikine treatment regimen followed by surgery and radiation compared to receiving surgery and radiation alone, the current treatment paradigm/SOC for these patients.

• CEL-SCI is near completion of the expansion of its existing dedicated cGMP manufacturing facility for Multikine. The construction, which began in 2020, will double the current facility’s capacity to accommodate two shifts for increased production of Multikine.

CEL-SCI raised net proceeds of $53.6 million during the nine months ended June 30, 2021 through the sale of common stock and the exercise of warrants and options. As of June 30, 2021, CEL-SCI had $47.1 million in cash, cash equivalents and U.S. Treasury Bills.

“The results of this 10-year landmark study proved our novel concept of cancer treatment, 1) that the use of our investigational cancer immunotherapy Multikine before the usual first cancer treatments (as neoadjuvant treatment) should significantly increase survival and 2) that a cancer drug can have a very favorable safety profile. Our Phase 3 study results are the first sign of real progress in the treatment of advanced primary head and neck cancer in many decades. We estimate about 210,000 patients per year globally who could potentially benefit from this drug once approved. Our goal is to seek FDA approval based on the data from our recently concluded pivotal Phase 3 study,” stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported an operating loss of $27.7 million for the nine months ended June 30, 2021, versus an operating loss of $20.5 million for the nine months ended June 30, 2020. CEL-SCI reported an operating loss of $10.5 million for the quarter ended June 30, 2021, versus an operating loss of $7.0 million for the quarter ended June 30, 2020.

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 pivotal 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 arms of the study. This study milestone occurred in late April 2020 and database lock occurred in December 2020. The study results announced in June 2021 showed excellent survival benefit for those patients who received Multikine treatment regimen plus surgery and radiation. When chemotherapy was added to radiotherapy following surgery the survival benefit was negated.

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.

CEL-SCI CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

NINE MONTHS ENDED JUNE 30, 2021 AND 2020

(UNAUDITED)

     

2021

2020

   

Grant income

 

$

-

 

$

530,106

 

   

Operating Expenses:

 

Research and development

 

 

17,818,373

 

 

12,680,430

 

General and administrative

 

 

9,902,120

 

 

8,389,821

 

Total operating expenses

 

 

27,720,493

 

 

21,070,251

 

 

 

 

Operating loss

 

 

(27,720,493

)

 

(20,540,145

)

   

Other income

 

 

(8,213

)

 

38,741

 

Loss on derivative instruments

 

 

(991,562

)

 

(3,565,347

)

Warrant inducement expense

 

 

-

 

 

(805,753

)

Other non-operating gains

 

 

1,436,473

 

 

774,245

 

Interest expense, net

 

 

(872,457

)

 

(777,898

)

 

 

 

Net loss

 

 

(28,156,252

)

 

(24,876,157

)

Modification of warrants

 

 

(350,861

)

 

(21,734

)

 

 

 

Net loss available to common shareholders

 

$

(28,507,113

)

$

(24,897,891

)

       

Net loss per common share - basic

 

$

(0.71

)

$

(0.69

)

Weighted average common shares outstanding - basic

 

 

39,907,624

 

 

36,230,092

 

   

Net loss per common share - diluted

 

$

(0.74

)

$

(0.69

)

Weighted average common shares outstanding - diluted

 

 

40,158,321

 

 

36,230,092

 

   

CEL-SCI CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

THREE MONTHS ENDED JUNE 30, 2021 AND 2020

(UNAUDITED)

     

2021

2020

   

Grant income

 

$

-

 

$

195,874

 

   

Operating Expenses:

 

Research and development

 

 

7,182,099

 

 

3,969,070

 

General and administrative

 

 

3,274,480

 

 

3,192,403

 

Total operating expenses

 

 

10,456,579

 

 

7,161,473

 

 

 

 

Operating loss

 

 

(10,456,579

)

 

(6,965,599

)

   

Other (expense) income

 

 

(8,213

)

 

1,845

 

Gain (loss) on derivative instruments

 

 

1,116,619

 

 

(1,282,829

)

Warrant inducement expense

 

 

-

 

 

(805,753

)

Other non-operating gains (losses)

 

 

761,237

 

 

(950,935

)

Interest expense, net

 

 

(351,332

)

 

(273,708

)

 

 

 

Net loss

 

 

(8,938,268

)

 

(10,276,979

)

Modification of warrants

 

 

(265,082

)

 

-

 

 

 

 

Net loss available to common shareholders

 

$

(9,203,350

)

$

(10,276,979

)

           

Net loss per common share - basic

 

$

(0.22

)

$

(0.27

)

Weighted average common shares outstanding - basic

 

 

41,020,485

 

 

37,453,539

 

   

Net loss per common share - diluted

 

$

(0.25

)

$

(0.27

)

Weighted average common shares outstanding - diluted

 

 

41,231,082

 

 

37,453,539

 

   

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20210816005105/en/

Gavin de Windt CEL-SCI Corporation (703) 506-9460