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Tuesday, January 21, 2020

H.C. Wainwright Starts CEL-SCI (CVM) at Buy

Analyst Vernon Bernardino initiates coverage on CEL-SCI (NYSE: CVM) with a Buy rating and a price target of $18.00.
The analyst commented, “CEL-SCI is a clinical-stage biotechnology company focused on developing therapies that activate the immune system to fight cancer and infectious diseases. We are bullish on CEL-SCI shares based on: (1) the potential for lead product Multikine, a patented defined mixture of 14 human cytokines, to be the first neoadjuvant cancer drug to improve survival in head and neck (HN) cancer patients by its administration prior to surgery and initiation of conventional treatment; and (2) Independent Data Monitoring Committee (IDMC) recommendation for advancement of the ongoing Phase 3 clinical trial that we believe suggests a favorable outcome in Multikine-treated patients. While IDMC updates generally provide limited insight into the status of an ongoing clinical trial, the Multikine Phase 3 trial was initiated in 2011 and has been ongoing for approximately eight years, with the last patient enrolled in 2016. We believe reviews the IDMC conducted in 2019 point to an overall survival (OS) benefit with Multikine, and thus, we do not look for the next IDMC review, expected in 2Q20, as required for further confirmation. At this point, we believe ethical issues may need to be considering in continuing the Phase 3 trial, and look for CEL-SCI to pursue a discussion with the FDA and EMA for a regulatory decision that results in the Phase 3 trial being unblinded in 2H20. We believe the potential for Multikine to achieve better survival outcomes remains underappreciated. Therefore, we initiate coverage with a Buy rating and $18 price target.”

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