Theratechnologies Inc T.TH

Full report from Doug Loe

[jeffm34]

https://leedejonesgable.com/wp-content/uploads/TH_2021_01_07.pdf

[jeffm34]

"We expect to revisit our assumption on preferred target indication for TH1902 once we have Phase I tumor response data to review, probably near end-of-F2022 if the trial commences enrollment in early FQ321 as Thera predicts." He's not expecting to see tumour response data until the end of 2022?  

[SPCEO1]

If you have followed Doug over the years, you know he always puts extended time lines in like this. I imagine he does it simply because almsot all trials seem to suffer delays one way or the other. As we know, the cancer phase I is now starting sometime in the second quarter rather than March, so it has already had a delay. And we don't know if that means its starts in April or June. Also

[Wino115]

I appreciate his conservatism on time, but his revenue numbers appear too high unless he knows something we don't.  He also uses a crazy 35% discount rate. Maybe those two things cancel each other out.  Anyway, my guess is he has a tiny audience and has zero impact.  I had noticed the slippage so hopefully it's only a month and not 3 months. The trial is posted, the CRO

[qwerty22]

The data will come in stages. The types of info that support approval are ORR, DOR, PFS etc (go learn the language of RECIST). Before that we certainly will start to get reports on safety and an efficacy signal as they get something meaningful but that will be on small numbers of patients maybe over several indications and there is no way to construct ORR etc from those. The first stage data

[Wino115]

Right, and I would assume TNBC is lead but that they would rank pancreatic and ovarian pretty close behind based on large population of unmet need.  I suppose you could say the same for colorectal, but like you say, they can't do it all in the first trial. They can clearly tackle them quickly thereafter and will be trialing TH1904 at some point. I guess you go for the ones where the

[jfm1330]

According to their Investor Day presentation, only 30% of pancreatic and colorectal cancers are overexpressing the Sortilin receptor. In my view they cannot go in phase II in these without a screening tool. Biopsies and histology tests would do that job, but it is hard to imagine biopsies being done on advanced cancer patients just to participate in a clinical trial. That with just 30% of chances

[Spartrap]

Not disagreeing with the usefulness of a screening tool at some point. But the (putative) secondary MOAs we talked about, VM disruption and IL-6/Progranulin pro CSC effect might not need significant Sortilin over expression. We could still see responses in terms of SD which are very valuable for aggressive cancers.

[qwerty22]

From what I understand sortilin on the cell surface is mostly restricted to the brain so we don't know how much sortilin on the surface of a cancer cell is required to trigger some of these effects you talk about, it might be minimal to start the signalling cascade. Making an assumption that high sortilin expression is required potentially loses you market, let the data decide this by taking

[Wino115]

Good point.  I think your approach is right.  In case someone doesn't have that old R& D day presentation, here's the slide.  I actually don't recall if this is the level of overexpression of Sortilin or is the percent of tumors in these cancers that overexpress Sortilin at what they consider a "high" level. Maybe JFM can recall what they mean here. 

[jfm1330]

In fact, the percentages in the Investor Day presentation are not about overexpression, it is just about expression, and it is already known that the more a cancer is advanced, the more the Sortilin receptor is expressed. Here is the link to the Investor Day presentation. https://www.theratech.com/wp-content/uploads/2019/10/Investor_Day_Nasdaq_Oct_23-1.pdf

[jfm1330]

You can have cancer cells at different stages of evolution within a tumor, but you won't have differences of stages between tumors in a same patient. Since cancer is an evolving disease with genetic mutations happening along the way, advanced cancers are by definition genetically heterogenous. Genetic heterogenicity means heterogenicity in protein expression (receptors, enzymes, etc...)

[qwerty22]

Not really, technically there is no lead at the moment. The results of Ph1 will determine which is the lead indication(s). At that point he can build his model around the market for those leads, I think he is right that you can't build a model based on all the indications in this first basket trial because it's unlikely all will proceed.  It seems their original plan was to go