VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2021, as well as key clinical and corporate developments.
Clinical and Corporate Developments include:
- During the first fiscal quarter, CEL-SCI completed the commercial scale build out of its dedicated current Good Manufacturing Practice (cGMP) facility in which it manufactures its investigational immunotherapy Multikine® (Leukocyte Interleukin, Injection)*. 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. Production capacity has been doubled to meet anticipated market demand for Multikine once it receives regulatory approval.
- Based on the results of its pivotal Phase 3 study, CEL-SCI intends to file a Biologic License Application (BLA) with the FDA for approval of the Multikine treatment regimen in locally advanced primary squamous cell carcinoma of the head and neck in patients scheduled to receive surgery and radiation as their primary treatments.
- CEL-SCI’s trial was conducted in over 20 countries in which marketing clearance applications may also be filed subsequent to FDA filing and/or approval.
- The 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. This is clearly an unmet medical need. The study showed great improvement in survival with no noted safety issues for these patients. The number of patients who could benefit from this treatment annually is large, estimated at about 211,000 globally.
- As of December 31, 2021, CEL-SCI had $37.1 million in cash and cash equivalents.
“Our current focus is in three primary areas, all of which are essential steps towards drug approval. First, we are assembling the clinical documentation required to obtain FDA approval of a Biologic Product License which will allow commercial marketing of Multikine, second, we are preparing and submitting our compelling data to peer review publications and third, on the production side, we are preparing the facility for FDA inspection as part of the Biologic Establishment License Application process. We look forward to providing updates on these essential steps as we reach milestones,” stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported a net loss available to common shareholders of approximately $8.8 million for the quarter ended December 31, 2021 versus a net loss of approximately $8.0 million for the quarter ended December 31, 2020.
During the quarter ended December 31, 2021, CEL-SCI completed a major upgrade of its leased manufacturing facility to prepare for the potential commercial production of Multikine. Total costs of this upgrade were approximately $11.1 million, of which the landlord of the property agreed to finance $2.4 million. The landlord financing is being repaid through increased lease payments over the remaining term of the lease.
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. 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 the Multikine treatment regimen plus surgery and radiation. When chemotherapy was added to the radiotherapy, the survival benefit was negated.
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
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2021 |
|
2020 |
||||||
Operating expenses: |
|
|||||||
Research and development |
$ |
6,083,167 |
|
$ |
5,414,760 |
|
||
General and administrative |
|
2,760,208 |
|
|
3,316,156 |
|
||
Total operating expenses |
|
8,843,375 |
|
|
8,730,916 |
|
||
|
|
|||||||
Operating loss |
|
(8,843,375 |
) |
|
(8,730,916 |
) |
||
Gain on derivative instruments |
|
364,596 |
|
|
932,836 |
|
||
Other non-operating gains |
|
(30,793 |
) |
|
121,606 |
|
||
Interest expense, net |
|
(273,034 |
) |
|
(260,390 |
) |
||
|
|
|||||||
Net loss |
|
(8,782,606 |
) |
|
(7,936,864 |
) |
||
Modification of warrants |
|
- |
|
|
(85,779 |
) |
||
|
|
|||||||
Net loss available to common shareholders |
$ |
(8,782,606 |
) |
$ |
(8,022,643 |
) |
||
Net loss per common share |
||||||||
BASIC and DILUTED |
$ |
(0.20 |
) |
$ |
(0.21 |
) |
||
Weighted average common shares outstanding |
||||||||
BASIC |
|
43,077,961 |
|
|
38,670,247 |
|
||
DILUTED |
|
43,083,420 |
|
|
38,767,286 |
|
||
