CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended March 31, 2020 and provided an update on clinical developments:

  • On May 4, 2020, CEL-SCI announced it has been notified that it reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation for its pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Inj.) immunotherapy. The database is now being prepared for database lock. Once the database has been locked, the final analysis of the trial results can be performed.
  • In April 2020, the Independent Data Monitoring Committee (IDMC) for the Company's pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) performed a review of the study data and recommended to continue the trial without change. The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study.
  • In March 2020, CEL-SCI initiated the development of an immunotherapy with the potential to treat the COVID-19 coronavirus using its patented LEAPS peptide technology. CEL-SCI signed a collaboration agreement with the University of Georgia’s Center for Vaccines and Immunology to develop the LEAPS COVID-19 immunotherapy. Initial studies with COVID-19 corona virus aim to replicate prior successful preclinical experiments of LEAPS against H1N1pandemic flu in mice conducted with National Institutes for Allergies and Infectious Diseases (NIAID). These studies demonstrated improvement in both morbidity and mortality of animals treated with the LEAPS-H1N1 construct as compared to controls. We believe that our COVID 19 approach is unique for several reasons: 1) we focus on a non-changing part of the virus and 2) our immunotherapy has both anti-viral and anti-inflammatory attributes. The goal is to develop a more successful treatment for infected patients.
  • CEL-SCI raised approximately $16.1 million in gross proceeds during the six months ended March 31, 2020 through the sale of common stock through public offerings and the exercise of warrants.

“We have completed and will soon evaluate data from our pivotal global Phase 3 study, which is the world’s largest Phase 3 study in head and neck cancer. A successful study result will provide definitive proof of the concept established in our Phase 2 head and neck cancer studies, that immunotherapy should be given as the initial treatment of cancer right after diagnosis, before surgery, chemotherapy, and radiation which severely weaken the immune system. Should the study meet its primary endpoint, we expect CEL-SCI will gain the first FDA approval for a first-line treatment for advanced primary squamous cell carcinoma of the head and neck in about 60 years. We are grateful to all the patients, clinicians and investigators, clinical sites, and the entire team at CEL-SCI and our current CROs for completing this very large pivotal Phase 3 global study.” stated CEL-SCI CEO, Geert Kersten.

During the six months ended March 31, 2020, the Company’s cash increased by approximately $5.9 million. Significant components of this increase include approximately $12.9 million in net proceeds from the sale of common stock through public offerings and approximately $2.1 million in proceeds from the exercise of warrants and options, offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $8.0 million, approximately $0.8 million of equipment and leasehold improvement expenditures and approximately $0.4 million in lease payments.

CEL-SCI reported a net loss of $14.5 million for the six months ended March 31, 2020 versus a net loss of $5.2 million for the six months ended March 31, 2019. CEL-SCI reported a net loss of $9.0 million for the quarter ended March 31, 2020 versus a net loss of $6.4 million for the quarter ended March 31, 2019. The variance is largely due to the change in fair value of the derivative liabilities at the respective period ends. These changes were caused mainly by fluctuation in the share price of the Company’s common stock.

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, radiation and/or chemotherapy. 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 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 head and neck cancer. Per the study’s protocol, newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck were treated with the Multikine treatment regimen for 3 weeks prior to receiving the Standard of Care (SOC) which involves surgery, radiation or concurrent radiochemotherapy. 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. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups.

The Company’s LEAPS technology is being developed for rheumatoid arthritis and as a potential treatment of COVID-19 in hospitalized and at-high-risk patients. 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, including statements with respect to Multikine and the Phase 3 clinical trial of Multikine in patients with advanced primary squamous cell carcinoma of the head and neck. 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. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical trials or nonclinical 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 amended report on Form 10-K/A for the year ended September 30, 2019. 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, 2020 AND 2019

(UNAUDITED)

 

2020

2019

 

Grant income

$

334,232

 

$

277,183

 

 

Operating Expenses:

Research and development

 

8,598,960

 

 

6,304,260

 

General and administrative

 

5,197,418

 

 

3,313,985

 

Total operating expenses

 

13,796,378

 

 

9,618,245

 

 

 

Operating loss

 

(13,462,146

)

 

(9,341,062

)

 

Other income

 

36,896

 

 

36,127

 

(Loss)/gain on derivative instruments

 

(2,282,518

)

 

4,589,135

 

Other non-operating gains

 

1,725,180

 

 

421,353

 

Interest expense, net

 

(504,190

)

 

(907,332

)

Net loss

 

(14,486,778

)

 

(5,201,779

)

 

Modification of warrants

 

(21,734

)

 

-

 

 

Net loss available to common shareholders

$

(14,508,512

)

$

(5,201,779

)

   

Net loss per common share

BASIC

$

(0.41

)

$

(0.18

)

DILUTED

$

(0.41

)

$

(0.19

)

 

Weighted average common shares outstanding

BASIC

 

35,621,711

 

 

28,543,417

 

DILUTED

 

35,621,711

 

 

28,548,818

 

 

CEL-SCI CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

THREE MONTHS ENDED MARCH 31, 2020 AND 2019

(UNAUDITED)

 

2020

2019

 

Grant income

$

298,726

 

$

150,769

 

 

Operating Expenses:

Research and development

 

4,402,347

 

 

2,832,546

 

General and administrative

 

2,558,522

 

 

1,624,823

 

Total operating expenses

 

6,960,869

 

 

4,457,369

 

 

 

Operating loss

 

(6,662,143

)

 

(4,306,600

)

 

Other income

 

18,448

 

 

18,216

 

Loss on derivative instruments

 

(3,049,027

)

 

(967,171

)

Other non-operating gains (losses)

 

934,511

 

 

(730,823

)

Interest expense, net

 

(253,407

)

 

(461,303

)

Net loss

 

(9,011,618

)

 

(6,447,681

)

Modification of warrants

 

(21,734

)

 

-

 

 

Net loss available to common shareholders

$

(9,033,352

)

$

(6,447,681

)

   

Net loss per common share

BASIC

$

(0.25

)

$

(0.22

)

DILUTED

$

(0.25

)

$

(0.22

)

 

Weighted average common shares outstanding

BASIC

 

36,165,050

 

 

29,113,910

 

DILUTED

 

36,165,050

 

 

29,113,910

 

 

 

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

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