Theratechnologies Inc T.TH

Quick Summary

[scarlet1967]

 

 

Oncology:

No DLTs so far at 300mg/m2, 3 patients already have been treated with the drug, three additional patients are enrolled they are planning to start the Phase1b(basket trial)by the end of the May. CEO and CMO are very encouraged by preclinical results and planning to seek accelerated approval for one or more indications if results are promising so they can commercialize the drug as soon as possible. They believed the drug is safe at 300mg/m2 which is the equivalent of up to 10 times of intra cellular concentration of Docetaxel alone and that will be the RP2D for phase 1b and possibly later stages of the trial.

They are talking to Chinese companies but it seems they want to see efficacy results before entering any partnership.

NASH:

The CEO stated the potentials for their NASH asset is based on three elements, MOA(what they believe they already have and would like to prove it by initiating the phase2b/3 trial ), overcoming the manufacturing issue for F8(competitive administration method) which should be resolved anytime before end of 2022 and resolving the funding either by partnership agreement or none dilutive fund rising. They are still waiting for the agency’s feed back on the proposed phase2b/3 trial design

which is expected in few weeks.

Sales and cash:

Egrifta is doing very well with good margins.

Trogarzo’s sales seems to be stagnant however they are trying to commercialize the drug in several more European jurisdictions including France, they rejected Germany’s reimbursement proposal as it wasn’t feasible.

Despite setting up the infrastructure for Trogarzo’s commercializations and ongoing R&D expenses they still have about 34 millions compared with 40 millions last quarter. 

Overall they seem positive on the oncology and sales. As for NASH it seems like they are planning to go ahead with it despite the manufacturing issues.

 

 

 

[Wino115]

One important fact Marsolais slipped in to his discussion was that the importance of the new pre-clinical data was twofold -- one, the CSC data showed (essentially proved) that using sort1 does bypass resistance since nothing works on CSC --at least in vivo.  Second, showing the additional chemo and chemo combo both performing better than carboplat alone, along with the VM/anti-metastatic

[PWIB123]

I listened to the call this morning, and I must say I walked away feeling very optimistic about the future.  I do not have a scientific background, and I thought it was easy to understand what they were explaining.  I thought the call was excellent and provided more clarity on things I've read speculated here.  I'm still not at all happy about the way they've approached

[qwerty22]

Hard to see that making much difference short/medium term to the clinical program. It would require a whole new different set of trials than the ones they envisage now. Bigger, longer, more expensive. It's probably more of a bargaining tool in partnership discussions. Something to help potentials see the scope of this drug. I'm not sure this is exactly right but I think we should be

[Wino115]

I would agree, but just pointed it out because if any new biotech/cancer analysts were to start covering it, they would model out and discount back the various markets they think they can ultimately penetrate - even if they are a a few years further down the road from the lead indications.  If they formalize thinking about it this way for further studies later, it would actually have an

[jfm1330]

Highly frustrated with the answer from Marsolais when asked to corrolate what we know from preclinical and what he sees in phase Ia. He totally refused to answer the question coming back again to his freaking mice results. He said it was prematured to talk about what is going on in the phase Ia. Damn, it started a year ago and he is unable just the shed a little bit of light on what is going on in

[qwerty22]

I've spent several decades bashing my head against brick walls in trying to move preclinical and clinical programs forward. I see efficacy in the clinical trial as a brick wall that they haven't yet brought down but which can be with the next patient or the one after that ........ I think they are clearly signposting where to find the clinical efficacy, it's in the future (1b

[MAC7824]

First time poster, long time reader.  Invested in THTX (formally THERF) since 2014. I appreciate all of the insight from the posters as it has been very helpful to keep my attention on this company since THTX has done a very poor job of communicating.   I totally agree with this post, JFM. One sense I have gotten from this board is that we have been hopeful for "

[stockman75]

Good post MAC7824. I agree the confidence/positivity is normal for a board and management so we can't read too much into what they say. Even if things are looking a little bleak (and I don't think reality is bleak with oncology) management still wants to believe that the good news is around the corner just like us investors. They too will have confirmation bias. Christian is great at what

[Biobob]

I think it's encouraging and conforting to see 1. guidance confirmation 2. More hints of having something material in Th1902 3. Non dilutive approach to financing... encouraging.

[Wino115]

We are all tired of the wait...in fact, way past tired and well on to the end of our rope!  First, I'm a little disappointed all the questions thrown up here were not thrown over to management -or at least they weren't asked.  The question referred to by JFM was mine and I was hoping that the way I worded it would allow them to talk about what they've seen without having to

[qwerty22]

The drug if it's going to work has to have an efficacious dose, at the moment hopes rest on 300mg/mm2. My guesstimate is once they have enrolled the last 6 patients they will have 13 evaluable patients that have recieved 1 or more doses above 300. I've seen companies report responders from those sorts of numbers. I think Sutro and bcyc both did that. But you are right, not having efficacy

[SPCEO1]

One thing I am trying to get better at is stating precisely things around the question of efficacy because I think how it has been often loosely talked about by speed typing people like myself has contributed to what some of us actually mean. For me, there are three categories odf efficacy that we are talking about and I am going to name them so we can use that going forward.  1.) Efficacy -

[jfm1330]

To put it in a nutshell, I was very annoyed to hear them talking about TH1902 at 300 mg/m2 in humans allowing 10 times more docetaxel in cancer cells than the recommended 80 mg/m2 of docetaxel alone, as if it was a reality. If it's a reality you should have clear efficacy data on humans and not say we will have to wait until phase Ib to see that. Add to that the fact that some patients got at

[qwerty22]

1) I wouldn't talk about it in this way. There won't be a placebo arm and drug arm and there won't be stat sig to calculate between those arms. What happens is there will be an ORR and PFS number that will be agreed upon in advance as the target but with wiggle room depending on the toxicity profile. Sometimes analysts come out with what they think the ORR target is for a particular

[SPCEO1]

Very, very helpful - thanks! I have no experience with a cancer drug going through trials so all the nomenclature and procedures are new to me. If I understand you correctly, there is almost nothing that you would see in the phase 1a that would convince you of anything related to efficacy. Is that correct? So we should just stop talking about it regarding the phase 1a altogether as there is

[jeffm34]

What might be helpful is the types of cancers the patients in the phase 1a trial have.  Some of the patients will have cancers that do not over express sortilin therefore will not respond. Some of the patients will have been given a subtherapeutic dose therefore no likely response. Some of them might have only received 1 cycle of treatment therefore unlikely to see a response. What are the

[SPCEO1]

It is hard to disagree with JFM's frustration in this post of his. It  is a first class rant and on point. Still, I have some comments, thoughts and questions as can be seen in red below: 

[Momo25]

Every argument JFM made about his disappointment and dissatisfaction in regard with the company attitude and its evident absence of communication is faced by a counter argument from Speceo who made his feet in Paul Lvesque shoes. Incredible ! isn't it ?

[SPCEO1]

What is incredible is that you apparently cannot read very well. Stop distorting and try to actually add some value to this top flight message board. We are all happy here to debate whatever negative sceario you want to put forward as we do alot of that already. I am not sure what purpose distorting things serves though.

[qwerty22]

All JFM is doing is bemoaning the lack of clinical trial data. I don't see anybody, even SPCEO, countering that. What do you do once you realize you don't have the data you really want? Seems to me SPCEO goes looking for other things (like the ex-Pfizer advisor being onboard). Something both Jfm and me don't do so much. Maybe the differences of opinion comes from looking at the problem