Theratechnologies Inc T.TH

RE:RE:RE:RE:RE:RE:RE:Expectations too high. Reset your animus.

[Wino115]

Me in Red.

SPCEO1 wrote: Good points but let me push back some. The assumption of 50% dropping out of the trial in 1a is not something we have actual data on, right? I don't remember seeing that. It may be a fair assumption, but it is a guess as far as I am aware.  Correct, it's a guess and nothing was ever released saying that. I was roughing it in my head that at the end, they only had 6 patients carrying-on and overall there was around 15-18 in the trial. I didn't bother pulling out the old slide to actually count, but I think that's conservative.

Also, the target patients are supposed to be better than in the 1a on average so the efficacy results should be better. I just recall that on the clinicalgov site that part 1a and 1b each were basically the same except the latter specified exactly which type of cancer.  But both were"... advanced solid tumors refractory to standard care...".   Maybe it will be a less advance cohort, but it sounds like it's the same entry criteria --3 months to live, etc...  There's only one criteria section for both parts.

I think the general lack of energy on today's call and the evasivness on TH-1902 questions specifically tells us there may be more to it than what you are suggesting. TH could have been similarily evasive while still leaving us feeling like they have seen something in the early phase 1b patients, They did not do that. Their commentary today was at odds with their recent presentation at the Cantor conference where they indicated the "think they have the key to unlock cancer cells". That suggested excitement was building as a result of the phase 1b info they were seeing but somehow that excitement was not present today.  I would agree the "excitement" wasn't there. I guess I'm weighing it with other statements made within the last few days, like "eager to discuss results", etc... and realizing they just can't say much of anything until they hit the endpoint data and have it all checked, discuss with investigators, have next steps worked out, etc...  In other words, they didn't back track either so they're still eagerly awaiting it and stated everything is still progressing as planned.  The "planned" is to get the patients, get them many cycles, scan them etc..  I take your point that it's fair to say that if we hold them to the past comment, it means they cannot say with 100% certainty and with investigator input that they've conclusively gotten 2 or more 6 week+ scans showing RECIST 30% reductions or more.  Maybe we find out with this PDC it takes more like 3 to 4 scans to see those reductions given the advanced and refractory nature. Who knows? In many of the tumor vs time charts they've shown, it does appear sometimes it takes 3 or more to start seeing serious tumor reduction. In some of those cases, they're just moving tumors slowly down where the control and docetaxal ramp way up uncontrolled. A therapy that lowers tumor burden 5% every 2 weeks and you can take for a year is still a wildly good result for a patient.  Maybe that's what they have in some of these cases.  It's just not rapid in all cases, but it's working over time in a successful way.  We just don't know, but between that and the likely still small number ongoing, they didn't hit 2 in one tumor type. 

If the problem is low enrollment, they probably should have admitted to that as it would have left me feeling better about the situation and more hopeful about the future. You may remember that I was surprised my cousin was accepted into the trial given how bad off she already was. She looked like she had just walked out of a German concentration camp. So much so that a very kind women followed her out of the Gettysburg clinic on her first visit there about a month before she started treatment and gave her some flowers the clinic had to wish her well. She clearly saw how bad off she was and extended that kindness to her, which was a real blessing to my cousin. My sister was even afraid she might die in her car on the trip to Gettysburg. Fortuately, my cousin was not in any pain right upuntil the end. The point I am trying to make is she did not appear to an untrianed eye to have 3 months of life left and yet she was admitted to the trial. Did that reflect difficulty in recruiting patients?  Good points. I'm not sure there's any real "scientific" way to guess that but the oncologists certainly should be better at that. The only requirement is the patient is on the ECOG scale at 0-1, which means they can still walk and mildly take care of themselves. So the requirement is just you're not bedridden and the oncologist is guessing you can make it 3 months. I've always suspected that smaller shops with fewer trials probably just want to give them something. And the bigger sites like MD Anderson, Cedars Sinai and the two Midwest ones you are really competing for enrollees and you get the very final ones given what this is looking for. You probably also really need a strong and vocal advocate who informs all the doctors and pushes for enrollment. THTX is likely toward the bottom of those lists until the  target, peptide science and overall approach gains more traction. I noticed Funda-Bernstram (their lead PI) recently talked at a conference about new drugs and it was some other immunooncology drug she presented. Hopefully one day she'll be 100% on board pushing TH1902 but I think it needs this lab and primary endpoint certainty before the big ones really jump on board. I would hope P2 would go way, way quicker since there's fewer at that stage and, we hope, results may warrant that kind of exceitement. 

But I don't disagree it was way too low key and non-revealatory.  I guess I had started to rachet down my expectations thinking through the difficulty of the enrollee situation and would bet they probably have enrolled around half (25 or so) but don't have more than a dozen who are in to the scan process and probably spread around in cancer type. But  they absolutely missed a chance to keep the story rolling positively without saying a whole lot.  They should have discussed a few tidbits of the PK from 1a --how that's been informing the  trial --  an anecdote or two, something.  But it was just "on plan" and "eagerly awaiting".  

Wino115 wrote: It is, no doubt, but to be realistic let's recall that the requirements to enroll are still that you have to be heavily pre-treated and refractory to all standard treatment options. It's still just not a very easy population to deal with in any kind of trial.

For instance, let's just assume they see a good response rate of 40% but also have the same death or curtail rate as the 1a trial.  If they've enrolled 25 people in the last 5 months, then a good response rate would be 10 people responding. If the dropout rate due to death/life issues/etc.. is roughly 50% (which seems to be a conservative number based on 1a), then maybe you had 5 get to the point where 3-4-5 cycles showed 30% tumor reduction. What if each was a different cancer?  Then still no protocal extension.  

I just think that we're seeing, once again, the difficulty in testing your therapy on the kind of population necessary to prove your science up.  It's the right population to show amazing things, but it's got a much higher difficulty-rating based on patient baselines.  It sucks, but we'll just have to be patient ....

Bucknelly21 wrote: The main thing as rusty said, 5 months in and you dont have efficacy? That seems to be a little concerning to me