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Theratechnologies Inc T.TH

Alternate Symbol(s):  THTX

Theratechnologies Inc. is a Canada-based clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of therapies addressing unmet medical needs. It markets prescription products for people with human immunodeficiency viruses (HIV) in the United States. The Company's research pipeline focuses on specialized therapies addressing unmet medical needs in HIV, nonalcoholic steatohepatitis (NASH) and oncology. Its medicines include Trogarzo and EGRIFTA SV (tesamorelin for injection). Trogarzo (ibalizumab-uiyk) injection is a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. It blocks viral entry into host cells while preserving normal immunologic function. The Company is also investigating an intramuscular method of administration of Trogarzo. EGRIFTA SV (tesamorelin for injection) is approved in the United States for the reduction of excess abdominal fat in people with HIV who have lipodystrophy.


TSX:TH - Post by User

Comment by qwerty22on Jul 15, 2021 3:32pm
141 Views
Post# 33553612

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Volume pickup last 45 mins

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Volume pickup last 45 mins

I wanted an interim readout as part of a COMMERCIALLY VIABLE TRIAL. I know you see how massively important that is. That's not some trivial part of the puzzle. What we have is a piece of paper with a plan on it not an active clinical program.

I knew it all along they wouldn't put all the necessary pieces together but in my naivety I held on to some hope of a creative solution. A partnership might still be that creative solution but the path has now narrowed. It's no good to just say everything is still on the table because it isn't, some options disappeared today. And the possibility for NASH to add to the value of the company in the foreseeable future has also now gone.

Anyway it's not killing the stock today. The market had set it's expectations about right. We didn't.


scarlet1967 wrote: The NASH protocol including the futility part is harmonized and completed. That's all they said that's what they have managed to put together to get both agencies onboard if they had resources they most likely would have waited with the partnership but they are although with good cost management lately still not flooded with $$. That's why this is to me a business decision. The risks to go alone with the program outweighs the return so they want to bring in a partner as the costs are higher than anticipated. You always wanted them to add an intrim
arn with biopsy confirmed fibrosis patients now they did that yet you see this as inactive protocol? 

qwerty22 wrote:

"none futility". What does that mean? They have to prove none futility because they don't yet have data supporting none futility. That's a clinical thing, or the lack of a clinical thing. That is what they are telling us is adding to costs. Basically more patients. Of course clinical assessment is part of the business decision. They are actually saying it's central to this decision.
 

 

scarlet1967 wrote: We have agreed and disagreed on many things but I have to agree with your assessment. They are very confident about oncology thus far, they are screening patients at all centres and by now they should have been well above the MTD for docetaxel equal to 230mg/m2 of their ODC. The NASH decision is a business decision not based on clinical assessment.

 

jfm1330 wrote: Just a week ago I wrote that. So I told you in advance. What happened today is what I saw coming, the news is just out sooner than I expected. I listened to the call before commenting... It was clear to me, but it is even clearer now, they really think they have something groudbreaking in oncology.

In the press release it is written this:

The first half of 2021 has been marked by progress across our R&D pipeline of novel compounds. Our Phase 1 clinical trial of TH1902 for the treatment of sortilin-expressing cancers progressed as planned during the quarter and we believe that we have developed a targeted peptide-drug conjugate that may potentially transform the way cancer is treated.

This is an enourmous statement and Levesque reiterated it directly from his mouth in his presentation. He is not saying it could potentially transform the way triple negativer breast cancer can be treated, or another specific cancer type. No. His statement his much broader than that it applies to how it could transform the way cancer is treated in general, and we know that many cancer type are overexpressing sortilin, and we know that this expression only intensifies as a cancer is progessing to more advanced stages.

All that to say that oncolgy is now clearly the leading program of the company. The one with the most potential, the less expensive to clinically develop, the one with the quickest path to market, and the one, by far, with the better potential for expansion, as it could work in so many cancer types and with so many PDCs variations with different cytotoxic agents. If SORT1 is as good as it looks it could be, a company like Thera will have its hands full just developing it to its complete potential. I don't see them hadling NASH on top of oncology. And if SORT1 is as good as it looks it could be, it will be a incredibly profitable asset.  So why would Thera go in NASH all by itself in this case? It would not make sense. That does not mean that the NASH program could not be a success, but the investment necessary just to validate that is huge.

I think the news today is a reaction to an evolving situation. Marsolais at the end of the call confirmed that they will for sure go above the MTD of free docetaxel with TH1902. The timeline they gave for interim results in Q4 is also pointing in that direction. As I wrote here before, remember that they already have interesting data on human about the way TH1902 is behaving in the human body, and remember that they have fast track designation from the FDA. So, I think that they already know the pharmacokinetics of the drug in humans and that is boosting their confidence level for what will follow.



jfm1330 wrote: A possible NASH approval would come only in four to five years and it would cost a lot of money to get there and it will not drive the SP until some positive interim data. Oncology is a totally different ball game. If it works, the will be a flow of interim data and news, partnerships with proprietary drugs, new PDCs with generic drugs or radioisotopes, and a lot of different new clinical trials on different types of cancer, breakthrough therapy, accelerated approval, etc...

If oncology is really a breakthrough technology, I would not be surprised to see them drop NASH or to partner it if they can find a company willing to invest in it. We are not there yet. It will all depend on potential good results in oncology and how good these results could be.


CreatingApe wrote:
what do you think...With a marketing ace from PFIZER as our new CEO? Also do you think a life saving cancer treatment and life saving nash treatment will sell more easily than a niche drug for people who have HIV and want tighter stomachs?? Tired of the Thera cant sell drugs complaints. This is a whole other ball game now. New leader and targeting much more aggresive markets. If either drug gets approval we hit the lottery.

 

 

 

 




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