SNTA - 1Q12 CC notes
[I actually more than doubled my existing SNTA position based on this CC. Some of the risks include me reading too much into what management (primarily the CEO) said during the call. SNTA management has had a long history of overpromising and underdelivering on ganetespib, including calls for a partnership. I did find the statements and vibe interesting during this call, though.]
1. Based on a "strong early signal of activity" during the GALAXY trial, SNTA expects to meet with the FDA and advance to the Phase 3 portion of the GALAXY trial at the end of this year.
2. SNTA expects the Phase 3 portion of the GALAXY trial will not be an "all comers" trial. This tells me SNTA only sees a signal in sub-defined NSCLC patient group(s), and not broadly across all NSCLC types. Management stated that the signals they are seeing are consistent with their incoming hypothesis and pre-specified analysis.
3. Sounds like a detailed update of GALAXY data will be presented in September at ESMO, though a more top-line PR may be issued later this quarter.
4. At about the 14-minute mark of the CC, in response to a question about utility of ganetespib against melanoma, CEO notes the potential but makes it clear that the focus of SNTA is on lung cancer. CEO states that it's extremely rare to get very strong results in 2nd line lung cancer and this would be the first time SNTA has positive outcome in final results "if things continue the way they are going" and "it looks very encouraging right now."
5. SNTA has received over 100 RSVPs in last 2 weeks for ASCO. SNTA has received meeting requests from nearly every major pharma for ASCO and will meet with pretty much all of them over the next month or two. SNTA expects to give further guidance later this year on partnering.
6. At about the 27-minute mark, CEO states that the ganetespib signal in the GALAXY trial "came quite early, almost surprisingly early, because it was quite strong" and it's "coming in pre-specified population and analysis defined when [they] went into the trial." [Obvious question is what exactly the signal is and is it sufficient for approval and does it represent a meaningful benefit? I am going to go out on a limb and guess that SNTA is seeing the signal in KRAS NSCLC. Key will be seeing more specific detail, presumably in September at ESMO, of the results.]
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