On December 20, 2018 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2018 (Press release, Cel-Sci, DEC 20, 2018, View Source [SID1234532199]). The Company also reported key clinical and corporate developments achieved during fiscal 2018.

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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. The Company is now awaiting final study results. 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 events have occurred in the two main comparator arms of the study and have been recorded in the study database. These final results could come soon since the last patients were treated in September 2016.
The Phase 3 head and neck cancer study’s Independent Data Monitoring Committee (IDMC) completed two reviews of the data from all 928 patients enrolled in the study in December 2017 and August 2018. The IDMC recommended continuing the study as constituted.
CEL-SCI won its arbitration against the clinical research organization (CRO) inVentiv that ran the Phase 3 head and neck cancer study from 2011-2013. The arbitrator ruled that inVentiv materially breached its contract with CEL-SCI. The arbitrator’s decision vindicated CEL-SCI. This successful conclusion ended a difficult period of time for CEL-SCI, and enabled the Company to move forward with a clean slate.
CEL-SCI started work designed to support the use of its first LEAPS vaccine product candidate, CEL-4000, in human studies for the treatment of rheumatoid arthritis, which will be conducted subject to an Investigational New Drug (IND) application. This work is supported by a $1.5 million grant received from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
CEL-SCI fortified its patent portfolio with three new patents for LEAPS and Multikine. The European Patent Office issued a new Multikine patent titled "A Method for Modulating HLA Class II Tumor Cell Surface Expression With A Cytokine Mixture". This patent addresses Multikine’s mechanism of action to make tumors more visible to the immune system. The U.S. Patent and Trademark Office allowed two new patents for the 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 raised approximately $21.4 million in gross proceeds during fiscal 2018 through the sale of stock and the exercise of warrants. This left CEL-SCI with about $10.3 million in cash on September 30, 2018.
"We are awaiting a readout of topline results from our Phase 3 head and neck cancer study, the largest of its kind in the world. Results are expected to be available soon. We cannot give a definite time table since we have to wait for 298 events to occur. If Multikine meets it primary endpoint, we believe it may change the way head and neck cancer is treated. We are hopeful that in addition to prolonging life for newly diagnosed patients, Multikine may significantly improve their quality of life by reaping the benefits of immunotherapy before surgery, chemotherapy and radiation therapy degrade their immune systems," stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported a net loss of $31.84 million in fiscal year 2018 versus a net loss of $14.36 million in fiscal 2017. The increased net loss in 2018 was mainly due to the non-cash derivative loss of approximately $8.6 million recorded during the year ended September 30, 2018 and the approximate $4.8 million non-cash portion of the interest expense. The derivative loss was the result of the change in fair value of the derivative liabilities due to an increase in CEL-SCI’s share price.

The Company’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the Company’s ability to continue as a going concern.