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CVM: Clinical Trials Update

By John Vandermosten, CFA


As we have stated repeatedly, we believe that we are in the final stages of the Phase III IT-MATTERS trial for Multikine. This assessment is based on historical event rates which suggests the final event will take place in the next few months. In CEL-SCI Corporation’s (CVM) a recent update to clinicaltrials.gov, we noticed that the anticipated completion was changed from December 2017 to December 2020. We logged a call into management and asked for clarification and were informed that the change does not reflect any new information regarding anticipated timing beyond that fact that we are still waiting for final events. The previous date of December 2017 had passed and management was required to update the entry to reflect this. Management stated that the new anticipated completion date should read September 2019. This date was determined by adding three years to the date when the last patient was enrolled in September 2016. The company is aligning the estimated completion date with the required follow ups on surviving patients.

We remind investors that management is blinded as to the number of events until the targeted 298 events have occurred, and they have received no new information since our initiation in January. Beyond knowing that the trial has not yet experienced its final event, there is no new information as compared to the prior update of the study to clinicaltrials.gov back in November 2018.

We continue to believe that there is substantial upside to CEL-SCI on a risk adjusted basis, as represented by our $14 price target and substantially more if the trial results meet or exceed primary endpoint of overall survival of 10% greater than SOC alone. Other transactions in the immuno-oncology space, such as the examples we provided in our initiation for Loxo Oncology, Tesaro, Stemcentrix and others have yielded transactions in the billions, demonstrating the opportunity that exists for a proven asset. We see weakness today as a good opportunity to accumulate additional shares at a discount to recent trading price with no change in the potential for the stock.

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