Replies to post #188320 on Biotech Values

[mcbio]

Re: ARQL 4Q14 CC (notes)

1. Based on recent enrollment rates in P3 METIV-HCC trial for tivantinib, ARQL expects the interim analysis to occur in the "first part" of 2016.

2. During Q&A, a caller asked about expected OS for tivantinib arm and control arm. The caller asked if 7-8 months is still expectation for tivantinib arm and if any recent data had changed expectations for the control arm. Management didn't really address the tivantinib arm so I assume 7-8 months is their expectation. For the control arm, expectation for OS is 4-6 months. Anyone have any comment on how much wiggle room there is in those expectations to get a positive outcome? Would 7 months OS for tivantinib vs., say, 5 months OS for control arm likely be a positive outcome?

3. At least as it relates to oncology indications, management clearly seems to me to be more interested in ARQ087 (FGFR inhibitor) than ARQ092 (Akt inhibitor). ARQL seems to be seeing the most efficacy for 087 in cholangiocarcinoma and that's the indication they seem to be focused on for P2. Biggest efficacy seems to be in cholangiocarcinoma patients with FGFR translocation. While management noted this is a smaller indication, it is more of an unmet need and could lead to quicker approval path. For 092, it seems like ARQL is more excited about the non-oncology orphan indications (starting with Proteus Syndrome where supposed to dose first patient end of 2Q).