Aurinia Pharmaceuticals Inc (AUPH)

[Lunacy_John Galt]

Aurinia is no longer just an LN focused company. Exciting news was released during the recent R&D day about venturing into new areas of interest. Overall this takes even more risk out of an already derisked clinical stage bio company while adding both short & long-term value to shareholders.

AUPH UPDATES:

AURORA LN TRIAL:
-Single Phase 3 trial (Duplicate of Ph2B)
-113 recruiting sites around the world and counting
-Expected completion date 2H-2018 & Top-line results expected 2H-2019
-Rolling NDA Submission 2H-2018 due to Fast Track Approval
-Conservative annual LN revenue: Approx. $1.4 billion

Oct. 20th R&D Day unveiled new exciting catalysts
-FSGS & MCD (Focal Segmental Glomerulonephritis & Minimal Change Disease)
-FSGS & MCD are causes of Nephrotic Syndrome
-Approx. 150,000 patients globally
-No approved treatments
-Reliant on off-label steroids and legacy CNIs (Cyclosporine)
-Ph2 POC trial expected 1H-2018 (Interim data release 2H-2018)
-Nephrotic Syndrome is an important unmet need

VOS (Voclosporin Ophthalmic Solution):
-VOS is a new nanomicellar aimed at treating DES (Dry Eye Syndrome)
-Market size is > 20 million patients in US along
-Improved potency, dosing, and tolerability compared to current standard of care (Restasis)
-Completed Ph1 human trial with small sample but promising efficacy vs. Restasis
-Licensed out VOS for canine use to Merck and completed animal studies
-IP to approx. 2031
-Ph2A trial to be conducted in 1H-2018 (H2H vs. Restasis)
-Low risk high reward opportunity
-2H-2018 AUPH will look to monetize VOS or conduct Ph2B