On May 18, 2021 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended March 31, 2021, as well as key clinical and corporate developments (Press release, Cel-Sci, MAY 18, 2021, View Source [SID1234580223]).
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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.