The systemic sclerosis phase II dosed its first patient a week earlier than the CF trial, with the company announcing on October 7 that it had dosed the first patient. This one spans 10 sites totaling 36 patients. Again this is a dose escalation study with a safety primary endpoint, but it also has a co-primary of change in Combined Response Index in diffuse cutaneous Systemic Sclerosis, or CRISS, which is an industry standard measurement used to determine severity and progress of the disease. This is a relatively short trial with top line expected also by December 2016, one year from now.
The final indication for dermatomyositis dosed its first patient back in July. Just like the systemic sclerosis trial, Corbus is going for two primaries endpoints on this one. The first is safety and tolerability, the second, a Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) measurement from baseline. The CDASI measurement is essentially a measurement of skin damage (dermatomyositis is associated with collagen degeneration), that will provide insight into the efficacy of the drug that the company can use to build on its safety data in determining the ideal dose for a phase III, assuming we get that far. This trial, though it began slightly earlier, will be complete the first half of 2017. It is funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health, so Corbus won’t be using its own capital.
And what about the recent insider and smart money buys? Over the past couple of months, Sean Moran, CFO of Corbus, has bought 15,000 shares, at a strike rate between $1.56-1.79. At the start of November, his total holding amounted to 60,250 shares, and now sits at 75,250, as per his latest December 12, 2015 purchase. A CFO would not increase his exposure to the company he leads if he did not believe it had some upside potential, and Moran’s consistent buying is a good sign that Corbus could be set for an upside revaluation near term.
The individual with the biggest position in CRBP is Sumner Burstein, whose total holding now comes in at 3,594,471 shares, giving him a 9.5% stake in the company. Burstein is the man behind the technology on which Resunab is based, and is the founder of Corbus. That he is willing to hold such a large position shows his belief that the drug will successfully make it to the market.
Another insider owner of interest is David Hochman, who sits on the board of directors at Corbus. Hochman is the man that cofounded, built and eventually sold Prolor Biotech to Dr. Phillip Frost’s OPKO Health (NYSE:OPK). He currently owns 657,200 shares of the company, amounting to a 1.75% stake.
From an institutional perspective, the organization with the biggest exposure to Corbus is Knoll Capital Management, LLC, which, during the third quarter of 2015, increased its holding by 1 million shares, to bring its ownership to 2.75 million shares, or 7.31% of the company. The second largest holding comes from Perceptive Advisors LLC, which increased its exposure by 380,000 shares last quarter, bringing the total holding to 1.25 million shares, or 3.3%.
Other notable funds that increased their exposure during the quarter include Vanguard Group (increased by 91,036 shares), BlackRock Int. Trust (increased by 180,607 shares) and Geode Capital Management (bought 91,235 shares to initiate a position). Full institutional ownership data is available here. Institutions that have maintained small positions in the company, but are worth mentioning by nature of their reputation in the space, include Morgan Stanley, DAFNA Capital Management and UBS Group AG.