• EDP-494 cyclophilin inhibitor for HCV will start phase-1 monotherapy trials in calendar 1Q16. ENTA’s eventual plan to is pair EDP-494 with an in-house nuke to make a 2-DAA HCV regimen for patients who are hard to treat due to the presence of RAVs from prior DAA treatment.
• ENTA’s FXR agonist for NASH will start phase-1 during 2016. This is the same drug class as ICPT’s OCA (#msg-111502128).
• During FY4Q15 (which predates any ABBV HCV sales in Japan), ENTA received V-Pak/Technivie/Viekirax royalties from ABBV at an annualized rate of $57M.
• ENTA’s pro forma cash balance at 9/30/15 was $253.8M. (This is comprised of $209.4M cash on hand; $14.4M in royalties earned but not yet received from ABBV; and the $30M milestone payment from ABBV for Viekirax approval in Japan.)
• ENTA expects to spend $40-50M on R&D during FY2016; however, inasmuch as ENTA is profitable and has an ample cash balance (see above), there are no plans to raise capital.