CEL-SCI (CVM) - 2021 Q3 - Quarterly Report

Clinical Trials and Product Development - The Phase 3 study of Multikine showed a 5-year overall survival benefit of 14.1% compared to the control group, translating to a 29% improvement (Multikine arm 62.7% vs control arm 48.6%) [130] - The company plans to seek FDA approval for Multikine, targeting an annual patient population of approximately 210,000 for advanced primary head and neck cancer [132] - The company has developed a pre-clinical technology called LEAPS, with potential applications for rheumatoid arthritis and COVID-19 treatment [134] Financial Performance and Expenses - Research and development expenses increased by approximately $5.1 million, or 41%, for the nine months ended June 30, 2021, primarily due to ongoing Phase 3 clinical trial costs [150] - The company incurred approximately $62.6 million in direct costs for the Phase 3 clinical trial as of June 30, 2021, with an estimated additional $4.3 million required to complete the trial [139] - General and administrative expenses rose by approximately $1.5 million, or 18%, for the nine months ended June 30, 2021, mainly due to increased employee stock compensation [151] - The company has spent approximately $7.9 million on upgrading its manufacturing facility to prepare for potential commercial production [147] - The gain on derivative instruments increased by approximately $2.6 million for the nine months ended June 30, 2021, reflecting changes in the fair value of derivative liabilities [152] - The company reported a cash increase of approximately $20.4 million during the nine months ended June 30, 2021, driven by $47.2 million in net proceeds from common stock sales [142] Capital and Financial Condition - The company anticipates needing to raise additional capital to support ongoing operations and product development efforts [137] - The Company bases its financial condition and results of operations on unaudited condensed financial statements [157] - Critical accounting estimates include operating leases and stock-based compensation, which significantly affect financial reporting [158] - The Company does not believe it has significant exposures to market risk [159]