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Biotech / Medical : IMUC- ImmunoCellular Therapeutics

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From: Geney	7/9/2012 1:21:12 PM
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*Summer Street Research Partners Company Update* IMUC (BUY, $8) — Enrollment in the GBM Phase IIb Trial Will Conclude this Quarter ImmunoCellular (IMUC-BUY) — Enrollment in the GBM Phase IIb Trial Will Conclude this Quarter: IMUC announced it is expanding its ICT-107 phase IIb trial from 102 patients up to 123 patients. Patients have glioblastoma multiforme (GBM) and are HLA-A1/A2 positive. There are currently 231 patients enrolled in the study, and more than 105 patients have either been treated or are scheduled to be randomized and treated over the next few weeks. The addition of these patients may shorten the time to reach the primary endpoint, a composite of overall survival (OS) and progression-free survival (PFS), by 2.5 months. The company estimates that the trial will be complete in 4Q13. The trial has 80% power to show a six-month improvement in OS. If the OS is greater than one year the results will mostly likely occur in 2014. An interim analysis is expected when 32 events have been observed, which we expect in 1Q13. This analysis is primarily a safety go/no-go. There is a remote possibility that the study could be stopped. However, the hurdle is very high and the P value would have to be below 0.001. We forecast ICT-107 sales of $34MM in 2016, rising to $576MM in 2021. Approximately 10,000 new GBM patients are diagnosed annually. About 80% undergo surgery and 70% of patients have the HLA A1 and A2 status required for the vaccine to work. This leaves ~6,000 available patients to be treated annually. Our YE12 price target is $8. Our price target is based on a 30x multiple of our 2018 EPS estimate of $1.80 discounted by 35%. REIT: BUY Price Target $8

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