Wanted to share some DD, this is one of my favorite plays over the next 60 days. Tucatinib (ONT-380) HER2+mBc breast cancer.
Cash - raised in June and now have 81M cash on balance sheet. Catalysts- - Laddenburg 2016 Healthcare Conf 9/27 http://wsw.com/webcast/ladenburg2/casc/ - ESMO abstracts 9/28 - ESMO data Oct 7-11 - SABCS abstracts Nov 6 - SABCS Dec6-8 updated Triplet study data https://clinicaltrials.gov/ct2/show/NCT02614794?term=ONT-380&rank=2 - FDA $CASC will release meeting updates from their discussion with FDA regarding P2 HER2CLIMB Study and specifically trial design changes to "potentialy" re power the 180 patient on going study to be a registration trial. This is an important potential catalyst as it changes timeline and cash burn to get Tucatinib (ONT-380) to market.
ESMO and SABCS: I will focus on a few things as data comes out
ESMO abstracts that will be released Wednesday. - data on a small series of patients with skin disease and response rates in that subset - "trials in progress" update
* I don't expect ESMO to be a critical catalsyt, but should set the stock up for a run into SABSC and FDA study desing update. I veiw these events as potential valuation drivers.
SABCS - updated data on Triplet Study *it's SABCS that investors should focus on more so then ESMO. - update on FDA discussions
TDM-1 P1b study PFS- 8.2 months with response rate of 47%
Triplet Study P1b study - these patients are next stage after receiving TDM-1+ trastuzumab+ taxane
May-16 early data showed 58% objective response rate and PFS of 6.3. For ESMO/SABCS are we still seeing north of 50% response? PFS trends? 7 to 8 months would be excellent results. These response and PFS rates should read through to their P2/3 HER2CLIMB Study. The P2/3 HER2CIMB study started December-15 is 3rd line. Powered conservatively with control arm PFS est. of 4.5 months vs KOL estimates from prior studies in this patient population of 3-4.5 months (expected response rate for control of 18%). So in theory we might expect the control to be less then 4.5 months and less then 20% objective response. If Tucatinib ONTY-380 can maintain the early PFS of 6.3 months or even extend PFS towards 8 months with response rates over 40% investors will be rewarded. The above is what makes this asset interesting, in particular since the drug appears to work in patients with brain mets, a historically hard patient population to treat.
Those are my thoughts, $CASC is loaded with catalyst next 60 days and tutes have been loading up. I am targeting a move over $2, but what do I know...
-BioHunter @The_BioHunter This is not investment advise or anything but my thoughts.
Some relevant slides from their last presentation.
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