Maxim Group Starts CASI Pharmaceuticals (CASI) at Buy
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Maxim Group initiates coverage on CASI Pharmaceuticals (NASDAQ: CASI) with a Buy rating and a price target of $4.00.
Analyst Gabrielle Zhou highlighted:
- CASI Pharmaceuticals is developing ENMD-2076 for Fibrolamellar Carcinoma (FLC), Ovarian Clear Cell Cancer (OCCC) and multiple solid tumors. ENMD-2076 is an orally available, "designer" molecule "built" for three modes of action: Angiogenesis Kinases, Aurora Kinases (cell proliferation), and Growth Factor Kinases (Fit-3, C-Kit, CSF1R).
- ENMD-2076 - proof of concept in man: Establishing a predictive biomarker. Preliminary results from a single-arm, single-agent (Canadian site) Phase II study (N=35) of ENMD-2076 in Ovarian Clear Cell Carcinoma (OCCC) were presented at ASCO. Data suggest patients negative for ARID1A (a biomarker) demonstrated higher progression-free survival (PFS).
- CASI recently announced the completion of the first stage of the two-part Phase II trial in Advanced Fibrolamellar Carcinoma (FLC), which allowed the company to advance to the second stage of the trial (primary endpoint of objective response for non-futility was met; interim analysis is underway). Both OCCC and FLC are orphan indications. If the data from Stage II are positive, it will help set the stage for a potential Phase II study expansion as a registration trial.
- Access to China. CASI is a U.S. company, but with Chinese expatriate management. Management sees the strategic opportunity to in-license U.S. therapeutics for the Chinese marketplace, with Zevalin, Marqibo and Evomela being the first. Over time, we believe they will contribute meaningful revenues (to offset the expense of U.S. drug development).
- Conclusion. CASI is a unique company with a designer therapeutic and a specialty pharma China-focused component. The lead asset ENMD-2076 is unique as a "designer" molecule with three modes of action. CASI is pursuing several niche indications with smart clinical trial designs that could generate proof of concept in man in 2017. We believe such data represent a value inflection for investors; with a sub-$100M market capitalization funded through multiple catalysts, we see a compelling risk/reward.
Shares of CASI Pharmaceuticals closed at $1.07 yesterday.
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