Aurinia Pharmaceuticals (AUPH) is a clinical stage biopharmaceutical company focused on developing and comercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need, explains small cap expert Tom Bishop, editor of BI Research.
The company is currently developing voclosporin, an investigational drug, for the potential treatment of lupus nephritis, FSGS and Dry Eye Syndrome. Aurinia has shifted from an early stage company with one program to a late stage clinical company with multiple programs.
The 320-patient, global 52-week Phase III “AURORA” clinical trial to evaluate voclosporin for the treatment of lupus nephritis (LN), initiated in May of 2017, remains on track to complete enrollmentin Q4 2018.
In addition, the Company announced that a 20-patient “Phase II open-label study of voclosporin has also been initiated for the treatment of FSGS, a serious and potentially life-threatening kidney disease, which is a leading cause of nephrotic syndrome. There are currently no FDA or EMA approved therapies for FSGS.
Aurinia also expects to initiate a 4 week, 90-patient Phase 2a head-to-head tolerability study of voclosporin ophthalmic solution (VOS) versus Restasis for the treatment of dry eye in the coming weeks, with data due around year end.
The goal here is to find the best in class treatment option including showing if VOS is more tolerable than Restasis. An estimated 20 million people are affected by dry eye syndrome in the U.S. alone and a fair percentage are not able to tolerate Restasis.
Moreover, the global market opportunity is currently around $4-5 billion and heading toward $6-7 billion by 2025.
Net cash used in operating activities during Q1 was $14.4 million and cash totaled $159 million as of 3/31, which they believe will be enough to accomplish the foregoing clinical trials and last into 2020. The shares of this underappreciated company remain a buy.
