ARQL - 2Q14 CC notes
1. With recent restructuring, cash runway has been extended another year (into 2017 now).
2. ARQL is now prioritizing ARQ092 (Akt inhibitor) over ARQ087 (FGFR inhibitor) because FGFR space very competitive and they feel they have better competitive positioning with ARQ092.
3. Regarding ongoing P3 tivantinib HCC trial, ARQL has taken steps to ensure accuracy of MET-high reading in patient tissue, which includes imposing time limitations on sample testing (within a week) and ensuring that the samples obtained contain high levels of HCC cells. Additionally, unlike in NSCLC, ARQL has found the borderline cases of MET-high and MET-low to be much fewer in HCC. It is apparently much clearer to distinguish between MET-high and MET-low in HCC.
4. The data in the P3 MARQUEE NSCLC trial has still not matured for the EGFR mutant sub-group.
5. Plan to present Phase 1a data on both ARQ092 and ARQ087 in November at EORTC. For 092, ARQL has seen a PR in lymphocytic lymphoma and long-term stable disease in neurocrine tumor of the pancreas, breast cancer, and osteosarcoma. There was also reference to pre-clinical 092 data being presented in October at the American Society of Human Genetics in a very rare and devastating disease outside of oncology.
6. ARQL believes front-line therapy in HCC from VEGF inhibitors enhances MET status and leads to more MET-high patients than MET-low. I.e., MET may be a resistance mechanism for VEGF inhibition.
