Company NOT going at it alone. NEW ASH Press Presentation..
Management states company's assumption is for a collaboration/handoff of CYT387 into PHASE3.
Great News! Early Speculation was a possibility of company using their 80mil cash to fund PHASE3 on their own.Looks like that option is now off the table due to this compelling trial data and obvious Big Pharma interest in this asset..
they said it this morning. Here is Merrill's take - not very positive, to say the least, on the data, but positive on partnership:
Management confident in partnership
At the company's analyst event this morning, YMI expressed confidence that
near-term it would likely partner its Jak inhibitor CYT387 for myelofibrosis (MF),
and that it was no longer necessary for the company to advance Phase 3 on its
own. We look forward to more details on the partnership.
Presentation fails to address key issues
Updated Phase 1/2 results (N=166) for CYT387 were presented yesterday. We
found nothing new despite significantly more patients included in this analysis vs
the original 60 patients studied. In particular, we had wanted a more rigorous
analysis of patients with well documented transfusion history in order to interpret
transfusion independence data (68% transfusion independence rate, overall IWGMRT anemia response rate of 48%). YMI addressed concerns around IWG-MRT
criteria at the analyst event, noting that it has subsequently evaluated 56% of pts
using more stringent Delphi consensus criteria (requires 3 month pt history vs.
IWG-MRT criteria of 1 month) and has observed the same result as per IWG-MRT
Thought leaders underwhelmed
MF thought leaders we spoke with following the data expressed significant
disappointment in the presentation, and pointed out concerns around (1) poor
spleen response (37% at 6 mos in 166 pts), (2) neurotoxicity (specifically 25%
peripheral neuropathy plus 2 discontinuations on core study) and (3)
thrombocytopenia (45% incidence with 24% experiencing grade 3/4 symptoms)