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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 jfm1330on Feb 18, 2022 2:18pm
164 Views
Post# 34442812

RE:RE:RE:Wow

RE:RE:RE:WowSo, finally, some people got more infos than the rest of us if what you say is true.  But if it's true, it's strange that they had to fight with a doctor about grade 2 toxicity in only one patient. The protocol clearly states that grade 2 toxicity is not dose limiting toxicity. Also, I still suspect that all comers and no prior testing for sortilin expression was a flaw in this protocol since I am quite sure that big diferences in sortilin expression can impact toxicity outcome. In other words, MTD would not be the same for a patient with high sortilin expression and high tumor burden, compare to patients on the lower side of this variable. Think about it, the dose is related to body size, expressed in "m2", so the bigger you are, the higher the dose they will give you in milligrams, but the same logic is not applied for tumor size, and sortilin expression on this or these tumors. I am quite sure this was an open door for confusion in the results.


SPCEO1 wrote: Based on feedback I got from people who spoke with management, thebest theory for why it has taken so long at the 420mg stage is that the first patient got sick, the doctor in charge of the trial wanted to step down to the lower dose, a debate ensued which TH eventually won, and they moved forward with three more patients at the 420mg level after a delay. I am piecing things together that may not be totally correct but I think that is a good guess for the reason for the slow progress. I also heard that at elast one patient was tested at the next level higher but I suspect they did hit some nastier side effects there and went back to the 420mg level. Again, I am piecing bits of info together so it may not be totally correct. Also, we know that one potential patient for the trial was told in early February that the trial was not taking any new patients. Of course, we do not know how much of a backlog of patients they may have had prior to that, so the trial may be still ongoing. 

Hopefully, we can stop guessing next week because they will share what has actually been going on in the trial. Here is how I would frame the possibilities for next week. 

Best case scenario: Trial is over, MTD is 420mg, some signs of efficacy seen and phase 1b starts next week - we should have some news on efficacy inphase 1b in three months.

Most Likely scenario - Trial is nearing its end, 420mg is looking like it will be the MTD, no news on signs of efficacy until we review all the data, phase 1b starting soon.

Worst case scenario - More delays in the trial due to issues at the 530mg level, months yet to go before MTD can be determined, no indication of efficacy seen so far.

jfm1330 wrote: You know like me that they cannot say stuff to a little group of investors or potential investors and not to the market as a whole. They decided to wait until the MTD is determined to do a press release, that's their choice. Now, it's taking so long that the quaterly CC will force them to give us some kind of an update on the trial. At least they will tell us at what dose they are right now and why it takes so long. I am not sure they will want to disclose efficacy data, positive or negative.

I think the actual low volumes are the consequence of how long this phase Ia is taking and the fact that they stated in the corporate presentation in January that they were still at 420 mg/m2. The delay is not the problem. The problem is that they were still at 420 mg/m2 in January. If they would have been at 742 mg/m2 it would have been another story. At least we could say, yes, it takes time, but they go to very a very high dose, but as far as we know, it is not the case.

They took three months to still be at the same dose, 420 mg/m2. This is confusing. They were at 420 mg/m2 at the beginning of November, and close to four months later, all we know is that are still at that same dose. Also, If I remember well, Levesque said in a call last summer that if they would see efficacy they would report it in the fall, and since then, we heard nothing. Is it because they are not seeing any efficacy signs or because they changed their minds and want to come out with a big news with full data, including correlation with sortilin expression?

There are other signs that seems to be positive, what you told us about positive meetings with big investors, hiring of a siRNA specialist and other hirings. But other than that we are in the dark, and the longer it takes, doubts creep in. So I think it's because of how long it takes that volume is low and SP drifting to lower level.

SPCEO1 wrote: It is nearly 1PM and less than 4,000 shares have traded in THTX today. With an important conference call next Thursday where there is a chance the company might give us a substantive update on the phase 1a, the lack of interest in the stock highlights management's utter failure in calling investors attention to the stock. It seems to me that management has done a pretty good job on most other fronts, but has really not even come close to figuring out how to manage the narrative investors hear about THTX. Of course, if you go several months saying nothing, there is not much managing that can be done! 

Nevertheless, as JFM repeatedly reminds us, the data will move the stock. But it would move further if TH got its act together in the all important area of cultivating an interested audience in the stock who was prepared to react in a big way to any big news the company shares. 

 




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