On February 14, 2022 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended December 31, 2021, as well as key clinical and corporate developments (Press release, Cel-Sci, FEB 14, 2022, View Source [SID1234608087]).

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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.