On August 14, 2018 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2018 (Press release, Cel-Sci, AUG 14, 2018, View Source [SID1234528892]). The Company also reported key clinical and corporate developments achieved during the quarter.
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Clinical and Corporate Developments included:
CEL-SCI’s Phase 3 head and neck cancer study continued to follow all 928 patients. Enrollment was completed in September of 2016. Based on published survival data, we believe top line results may be available as soon as early 2019. All that remains to be done in this pivotal Phase 3 study, the largest in the world in head and neck cancer, is to continue to track patient survival until it can be determined if the primary endpoint has been met. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. SOC alone, will be determined after a total of 298 deaths have occurred in the two main comparator arms of the study and have been recorded in the study database.
The US Patent and Trademark Office allowed two new patents to CEL-SCI for the Company’s LEAPS platform technology. Titled "Method for Inducing an Immune Response and Formulations Thereof" and " Method for Inducing an Immune Response against avian, swine, Spanish, H1N1, H5N9 influenza viruses and formulations", these patents relate to methods for diagnosing, preventing, and treating disease by generating or modulating the immune response through the use of specific peptides.
CEL-SCI won the arbitration against the clinical research organization (CRO) that ran the Phase 3 head and neck cancer study from 2011-2013. The arbitrator ruled that the CRO materially breached its contract with CEL-SCI. The arbitrator’s decision has vindicated CEL-SCI. Many investment funds and analysts did not like the legal risk of this arbitration and now that the arbitration has been resolved in CEL-SCI’s favor, this should no longer be an impediment to investors and should result in renewed investment interest in CEL-SCI. With the arbitration completed, CEL-SCI moves forward with a clean slate.
"We are proud of having run the largest head and neck cancer Phase 3 study in the world, in an indication that has not seen a new drug approved by the FDA in over 60 years. This has not been easy for many reasons, including the fact that our approach to immunotherapy involves treating the patient when they first get diagnosed instead of using immunotherapy as a last ditch option for survival. Our approach meant a longer clinical trial period, with nearly one thousand patients enrolled. Despite the many challenges of this study, we believe the potential to bring a new immunotherapy to help save the lives of newly diagnosed cancer patients has been worth it," said CEL-SCI’s Chief Executive Officer, Geert Kersten. "As we look forward to a readout of the endpoint data which may happen in early 2019, we also continue to develop our LEAPS technology platform with the support of the U.S. National Institutes of Health. Should our Phase 3 results lead to marketing approval in head and neck cancer, we will also have the opportunity to purse clinical development and marketing approval of our immunotherapy in other cancer indications."
During the nine months ended June 30, 2018, the Company’s cash remained constant. Cash used in operations of approximately $9.1 million was offset by approximately $9.1 million in cash provided by financing activities. Sources of financing during the nine months included approximately $7.0 million in proceeds from the issuance of common stock and warrants and $2.1 million in proceeds from the exercise of warrants.
CEL-SCI reported an operating loss of ($4,070,363) for the quarter ended June 30, 2018 versus an operating loss of ($4,758,719) for the quarter ended June 30, 2017. The operating loss was ($13,187,538) for the nine months ended June 30, 2018 versus an operating loss of ($17,603,283) for the nine months ended June 30, 2017.