Roth Capital Maintains Buy On ImmunoCeulluar Following 2Q14 Results
In a research note published August 8th, Roth Capital analyst Joseph Pantginis maintained a Buy rating on ImmunoCellular Therapeutics (IMUC) with a $3 price target, following the release of the company’s second- quarter results, the company ended off the quarter with $25.7 million in cash. In addition to the company’s quarterly report the company will be conducting a meeting with the FDA to discuss the potential Phase III next steps for ICT-107 in front-line glioblastoma.
Pantginis wrote, “Following a positive Phase II update at ASCO in June 2014, the company is ready to move forward and receive important regulatory advice regarding the potential next steps for ICT-107. Pre-specified sub-population data from the Phase II study of ICT-107 in front-line glioblastoma showed that clinical benefit occurred in HLA-A2 patients, as well as showing clinical benefit in both methylated and unmethylated MGMT patients. Having these important answers, the company is now set to engage the FDA and EMEA regarding a potential Phase III path forward, in our opinion. The company is expected to meet with the FDA by the end of the summer and will soon decide what its communication strategy will be surrounding the outcome of these meetings. The Phase III manufacturing process is now complete and the company now has two manufacturing companies prepped in Europe if needed, which will only require a straightforward tech transfer. IMUC is in early partnering discussions with multiple parties who have taken note of both the Phase II results presented at ASCO as well as the potential for combining ICT-107 with checkpoint inhibitors. While not defined yet, the Phase III will likely only be in HLA-A2 patients (~50% of patient population) and be a randomized study with target enrollment of ~600 patients. The upcoming meeting with the FDA will be very important, in our opinion, by providing much needed visibility about the path forward for ICT-107 and views about the clinical benefit seen to date. We expect to receive follow-up survival data from the Phase II study at SNO in November.”
Pantginis added, “Using prospectively defined subgroups, IMUC identified a true addressable population for ICT-107 based on both HLA status and MGMT status. No drug to date has been able to show a positive benefit in unmethylated MGMT patients, but ICT-107 has and this can provide an important framework for upcoming regulatory activities to define next steps for the product.”
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Joseph Pantginis has a total average return of -8.3% and a 36.4% success rate. Pantginis has a -44.4% average return when recommending IMUC, and is ranked #3167 out of 3214 analysts.
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