Theratechnologies Inc T.TH

Canaccord Warming Back Up to THTX?

[SPCEO1]

As we are painfully aware, the Canaccord analyst has had THTX in his penalty box for a long time. But he put out a prompt report this morning (recall it took him almost two weeks, which is incredible, to put out a report on THTX's last quarterly earnigns call) noting the start of the phase 1b which included a commitment to factor cancer into his model once proof of concept is seen.

When might that be seen? It could actually be earlier than we have been thinking in the phase 1b. If everything went perfectly optimally (which basically never happens) it would be possible we saw results from the second scans confirming preliminary efficacy by the end of June. How, you ask? Well, the pahse 1b got started earlier than we expected and some/all of the first three 300 mg dose patients may have rolled right into the phase 1b. If so, the phase 1b effectively started when those first three  patients got their first dose, which I am guessing occurred in late March since in mid April they had complete their first cycle of treatment (based on what was said on t he mid-April conference call). 

Now, I don't know the specific rules areound declaring preliminary signs of efficacy. First I have to assume you need at least two instances of tumor regression afer twelve weeks and two scans. This must have to be in the same cancer type as well. So, if two of those first three patients has the same cancer type and both showed tumor regression, then THTX can declare preliminary signs of efficacy, I think (any help with the rules around declaring preliminary signs of effcicacy from those in the know would be appreciated). The chances of all the conditions being met are tiny but it is fun to think about.  

My contact who mingled with the THTX honchos before the annual meeting yesterday heard there was to be a discussion at the board meeting following the AGM yesterday discussing some recent input from the investigators on the trial. Could that have been the results of the first scan? Were those reults positive or negative? We can only speculate but thereis a very small chance THTX is  already half way there to declaring preliminary efficacy.  
 
Then we can see how much credit Canaccord and the other analysts will give THTX for their cancer program. Whatever they give will be heavily discounted due to how early we are still in the testing program for TH-1902. But at least it will be something!

If you really want to keep dreaming, then hope that two of those first three 300mg patients had ovarian cancer and both show tumor regression. If that tumor regression is as good as seen with normal docetaxel patients where docetaxel is the first line of therapy for ovarian cancer, then things could speed up very quickly for TH-1902. A phase 2 study would be started pronto and, if TH-1902 was to reveal that it is better and safer than normal docetaxel treatments, it might get anaccelerated approval sometime in 2023 and it should then quickly become the first line treatment for ovarian cancer. 

OK, now it is time to come backdown to earth as the chances of any of that happening have to be 1 in 1000 or less. Everything would have to go right and that never happens, especially when you are dealing with very, very ill patients who have been through all sorts of cancer therapy already. 

Even so, we may get a preliminary efficacy signal sooner than we thought. but it likely will not be on the optimal type of cancer from our prespective, which I believe would be ovarian.

[jfm1330]

Remember Levesque last August said that as soon they would see efficacy they would report it. It was in phase Ia, so I don't think they need two patients with the same cancer type to report it. They just need scientifically solid results and the will to report it. Short term efficacy in my understanding is a partial response, and that means a tumor shrinkage of 30% or more per RECIST criterias

[SPCEO1]

The CMO reiterated they had to report preliminary signs of efficacy when they saw it. But it is all about exactly how that is defined. I have a high degree of confidence TH saw some indications of tumor shrinkage in phase 1a but they cannot say so other than on an anecdotal basis. For all they know, that shrinkage came from the new type of apple the patient was eating. So, they ahve to wait until

[qwerty22]

RECIST is all laid out here if you want to work your way through it. I think it's clear enough for non-experts if you want to have a go. https://project.eortc.org/recist/wp-content/uploads/sites/4/2015/03/RECISTGuidelines.pdf For me it's not a question of this being anecdotal. There are solid definitions of what constitutes a response, if you meet those definitions then you have a

[scarlet1967]

Nobody wants to hear hints but lets face it since the start of the trial March 2021 most likely half of the times they were collecting/analyzing data based on what they saw they have made some adjustments to 1b approached FDA and moving on now why they cant disclose anything more than MTD and what they saw was inline with the preclinical works? If they are aiming at 10 cycles and starting to enrol

[qwerty22]

Because we don't know exactly the circumstances of that "10 cycle" statement. It could have been nothing more than an unsupported aspiration. Some of us are running with it as though it's a solid target for this drug. This is little more than a rumour that seems to have transformed into a hard fact and now you seem to have decided that the most pressing concern is why they aren

[scarlet1967]

I dont think we ever agree on this subject as I said before scientists understand science salesman understand selling scientists/salesman sell the science.

[qwerty22]

We both agree on your statement. What we disagree on is whether the "10 cycle" thing is a scientific fact or just a rumour flying around this board. If it's a hypothetical turned into a scientific fact by this board then it has no place in a THTX PR. You want it in a PR and I'm suggesting it might be little more than gossip, consider that as a possibility.

[scarlet1967]

Thats why I want the company to solidify those hypotheses by speaking publicly about it. I dont think if correct the CMO would just make that comment based on thin air. Like yourself I want to know the facts but so early in the process there will be many hypotheses and there is nothing wrong to talk about it after all if those hypotheses become facts they are real financial potentials and in

[SPCEO1]

Moreover, I think TH is proud of how they are handling communications despite the obvious shortcomings and our constant berating them for how they do things. From my perspective, they are taking the most conservative stance you can on the continuum of stances that could be taken but they think they are in the middle of the road. And it is not helpful at all to investors like ourselves. There is a

[scarlet1967]

I think we have to differentiate the selling and the product. CYDY sold well their none existing product a scam so at the end they had to face the music if THTX would sell their prospects effectively I dont believe they would end up like CYDY. So in my opinion that was a miss going forward one has to hope they would get their act together but with this board and the chairwoman its more like a

[stockman75]

Wonder if they are proud of the stock price and lack of confidence the market has in their company? 

[SPCEO1]

I don't think they are proud about the stock price but they do not seem as alarmed about it as would be appropriate. Maybe after the Chairwoman has time to contemplate the votes against her at the AGM, the stock price, and marketing the stock more effectively, will get a higher priority. We voted in favor of the Chairwoman - had we not, she would have been in the low 60% range. I am assuming

[Biobob]

Maybe Th will be the only ten bagger this year... it was TSX60 top gainer back in 2018.. listen if oil went to zero and interest rates negatives and AMC and Bitcoin to the sky.. nothing, nothing is impossible.

[SPCEO1]

I believe one of the reasons for TH's hyper-conservatism in pitching their stock to investors is the result of the credibility problem they built up over time primarily with Egrifta and Trogarzo sales disappointments as well as the ONO and their overreaction to all that. Yet, despite heading to the conservative end of the IR spectrum, they still managed to add to that credibility problem

[SPCEO1]

On the 10 cycles thing - here is what I wrote in my notes, "10 cycles @ 300mg - won't see cumulative toxicity"  The CMO was the one who made that statement. I did not take this as a fact TH had already established but as a goal they were shooting for and one he thought Thb could achieve. But that is true of a lot of things thatnever get achieved, so no one should be banking on

[realitycheck4u]

This post has been removed in accordance with Community Policy

[realitycheck4u]

This post has been removed in accordance with Community Policy

[juniper88]

In clinical trial they have target lessions.  Only those count in whether or not the patient has a reponse, stable or progression.   That said, with my my the target lessions only grew by 5 to 10%, so technically stable disease for the purpose of the trial.  She could have stayed on for another six weeks to confirm.  But she had bad side effects and non-target lessions

[qwerty22]

Based on RECIST the rule is for you to call something a CONFIRMED response you need two scans to show a response and they need to be done at least 4 weeks apart (in our case probably 6 weeks I.e two cycles). An UNCONFIRMED response would be after just the first scan. Response means greater than 30% tumour shrinkage. My idea on scans (I don't know where I get this) is that they scan at the

[Wino115]

I've posted a few analyst comments on various P1 and P2 oncology drugs and you'll recall that there were a few where responses were very low --1 to 3 PR's and CR's out of a sample of 10-15 where analysts jumped up and down saying it essentially proved to them there could be a market for the drug.  It was usually accompanied by the type of tumor or receptor readings the patient