Major Overhang for ImmunoCellular (IMUC) Removed with CIRM Grant - Roth Capital

Roth Capital affirms ImmunoCellular Therapeutics (Nasdaq: IMUC) with a Buy rating and $3 price target after the company announced that the governing Board of the California Institute for Regenerative Medicine (CIRM), California's stem cell agency, has awarded the Company $19.9 million to support the ICT-107 phase 3 registration trial in patients with newly diagnosed glioblastoma.

Analyst Joseph Pantginis commented, We believe this is a significant achievement for IMUC and has removed a major overhang on the shares as the Phase III is now fully funded with current cash (2Q15 cash of $30.9 million) and this major grant. Recall the Phase III recently received a SPA from the FDA and is still slated to start in 4Q15. the study will enroll ~400 patients with HLA-A2 status at ~120 sites in the U.S., E.U. and Canada. The primary endpoint of the study is overall survival (OS) and is expected to begin late this quarter or early 4Q15. PFS is the main secondary endpoint as well as patient stratification by MGMT status and their OS outcomes.

In this Phase III, patients will be randomized following surgery and chemoradiation. An additional step of analysis post chemoradiation will be added in order to exclude progressive patients prior to randomization, which should help improve chances of success. The company expects full enrollment to take ~2 years and 2-3 additional years for the needed survival events to occur. Two interim analyses are planned, a futility analysis at 30% of events and an efficacy analysis at 66%. These are expected to occur at ~2 and ~2.5 years following the first patient randomized. With the potential of "time to data" representing another overhang, we expect the company to draw potential visibility from both ICT-121 and the Stem-to-T-Cell program.

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