Miehm hosted "fireside" chat with Cormack today in NYC (appropriate given the weather) and here are the highlights:
1. No changes to the timeline, end of 2013, for SYNERGY date presentation;
2. No significant disruptions to TEVA agreement and commitment to programme;
3. The evolving nature of prostate cancer treatments should have little impact on OGXI's strategy of introducing products (011 and 427) as improving treatment resistance for future an current therapeutics is more complementary than competitive
4. High levels of excitement around 427 bladder cancer trial but date not likely until end of 2014 but significant OS improvements could be the first for the indication in over 6 decades(!!!!!) (that is my emphasis, not Miehm)
5. Potential partnerships for 427 nearing meaningful discussions as data from multiple trials continue (!!!!!)(sorry, me again)
6. The company has cash of 80 ml and market cap of 175 ml which translates into a tech value of a company with a phase III trial nearly complete of under 100 ml
7. An interesting and overlooked opportunity in the oncology space
"1. No changes to the timeline, end of 2013, for SYNERGY date presentation;"
I may need to relisten to the webcast but I think I got the sense that the # of events required for data readout is expected to be by (the end of) 2013. The top line data presentation, which requires ~2-3m of analysis, may or may not be in 2013.
Summer nails it again. From today's PR (with the same point repeated in Cormack's presentation):
"The expected timing of results is based on a pre-specified number of death events that is projected to occur in the fourth quarter of 2013, with data results expected to be announced in the first half of 2014."
That could mean we'll get interim results on the P2 trial of 427 with Zytiga, which OGXI has said it hopes to present at ASCO GU next February, before we get results in SYNERGY. Which makes planning for how to hedge the SYNERGY results, by buying puts or otherwise, a little more complicated.
The only other news I caught today was that they've been granted fast track status for the P3 study of 011 in lung cancer.