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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. 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. Its portfolio includes Phase I clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate (PDC), in patients with advanced ovarian cancer.


TSX:TH - Post by User

Comment by qwerty22on Aug 11, 2022 1:31pm
107 Views
Post# 34888865

RE:RE:RE:Tranche 3 by end 2023

RE:RE:RE:Tranche 3 by end 2023

I don't think we should be exactly looking for the traditional 'end of phase' milestones. The flexibility they have with the fda is very real and it should lead to a more fluid situation.

So for example an expansion to 25 within the boundaries of 1b should/could be a very strong sign. If it's on the back of a couple of efficacy signs within a particular cancer indication which would be the go/no go signal from the 10 then hopefully they release both the news of an expansion and at the same time the reasons why. This is how I'm imagining things going forward. I'm not overly concerned exactly when 1b ends because data should be flowing before that.


SPCEO1 wrote: That was a presentation to institutional investors, most of whom, maybe all of whom, cannot buy a stock with such a low market cap, such a low absolute price and where trading volume has evaporated. So, that presentation should be considered an investment for the future - get people introduced to TH-1902 and have them aware of TH's story so that when the time is ripe, they will act. 

Also, they did not announce any important new info yesterday and didn't really address the phase 1b in anything other than very general terms. So, I don't think anyone was expecting a strong stock price reaction given all that. But it was a decent presentation and covered a lot of ground in a short period of time so that those who were there (and we know at least one person was there since he walked in late and crossed in front of the camera!) or who were listening online got a pretty good overview of TH from Paul.

The stock will likely move significantly when/if they start announcing good cancer data. We should not expect much from the share price until that happens. Maybe a Chinese partnership happens first and helps a little but I am guessing there are good reasons that has not happened yet. Maybe they do acquire an additional revenue source but it is hard to see how that would move the needle on the stock price much. I can't see how TH would want to sign a partnership with a Western big pharma right now, prior to phase 1b data they seem to expect to be positive, and even then, Paul previously described what type of partnership that might be (not one where the big pharma takes total control of the drug). So,a lot of developments might take place before cancer info which we hope will be one of three eventual protocol amendments to take different cancer types to 25 patients in the phase 1b trial.

I mentioned yesterday that I w as not clear what Paul was trying to tell us about the length of the phase 1b, probably because TH is not sure themselves yet as it will depend on whether or not they have protocol extensions. But even if they do not, it was not clear to me if he thought the enrollment would conclude in March 2023 or if the trial would be over by then since the enrollment would be finalized by the end of the year. In drug trials, it is normally best to assume it will take longer than expected so let's assume the trial is completed by mid-year 2023. What we do not know is how long it will take if there are protocol amendments. Let's say there is a protocol amendment announced in early October for endometrial cancer. How long will it take for TH to recruit the extra 15 patients? Maybe that happens pretty quickly since the amendment would be indicative of efficacy being seen and that may attract patients. So, there is a chance that even though the 1b is ongoing, a phase 2 could get started in a particular cancer type that saw early indications of efficacy in phase 1b and also so quick enrollment in the expanded portion for that cancer. Just thinking out loud about the options.    
 

Bucknelly21 wrote: Looks like yesterday's presentation was a huge hit, we are already 187 shares lol




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