CEL-SCI Corporation Issues Letter to Shareholders - Seite 4

We do not think the increased survival of the patients in our study is related to the dropout rate of patients either. While we are blinded to the study results, we have never heard from the CROs who run the study that the dropout rate is a problem. In addition, the actions by the Independent Data Monitoring Committee (IDMC) speak against that as well. The IDMC, which meets periodically to review the study and data in an unblinded manner (i.e., they see everything) is tasked with focusing on the following areas:

• Efficacy: to assess the primary efficacy measure as well as the conditional power and sample size
• Safety: to assess the magnitude of adverse events and monitor for safety concerns

In reviewing the conditional power and sample size the IDMC would be considering the dropout rate. If there was a problem with the dropout rate, then per the Charter the IDMC is required to tell us to enroll more patients. They have not done so. As recently as October 2019, the IDMC recommended “…to continue the trial until the appropriate number of events has occurred”. In their letter to us they said that they reviewed “…progression free and overall survival and limited demographic and safety data available for the aforementioned protocol.” This language tells us that they are following the guidelines outlined in their charter.

We are treating newly diagnosed cancer patients, hoping to improve the “intent to cure” treatment, and our Phase 3 trial is a very large event driven overall survival study, the ‘gold standard’ of studies for approval of cancer drugs. Patients have already been in our Phase 3 study between 3.5 and 9 years, and some people are asking how much longer our study will have to last. We knew from the start that since the study is event driven it might take longer to complete than we had estimated, however, it is taking even longer to complete than we thought. Many of our shareholders think that simply because it looks as if things are going well, the study should end before 298 events are reached so the product can be made available to help patients. This thinking is incorrect for our situation due to the event-driven study design.