Theratechnologies Inc T.TH

RE:RE:RE:RE:RE:RE:RE:RE:Thank you

[qwerty22]

I have to say I mis-read what jfm wrote, I thought he'd said they would wait until the end of dose escalation. I actually completely agree with Jfm, when I wrote 6-9 months I meant from the start of the trial so that matches jfm's timeline of Fall.

What you write might be right but the absolute earliest they might get a report of a shrinking tumour, I don't think they report at that moment, they probably wait for several cycles and more than one data point to confirm what they they have. I guess what I meant was once they feel certain they have something to report then they'll report it.

Here's an example from Sutro's STR-002 trial.

They initiated in Mar 2019

https://www.sutrobio.com/sutro-biopharma-to-present-at-the-2019-aacr-nci-eortc-molecular-targets-and-cancer-therapeutics-conference/

Their first written report of an efficacy signal came in Oct 2019

https://www.sutrobio.com/sutro-biopharma-to-present-at-the-2019-aacr-nci-eortc-molecular-targets-and-cancer-therapeutics-conference/

Maybe they'd been hinting verbally in cc in between those dates, idk,  but nothing written, I imagine they where getting reports of shrinking tumours throughout that time period. They did report some of their pre-clinical stuff like stability/toxicology in between.

The first time they really start to report data that's a little more meaningful in terms of cohort statistics (20 patients) rather than individual instances of tumour shrinkage is Apr 2020, I guess this corresponds to completed enrolment of thtx's part 2 of Ph1. For me this is the point when the data starts to get interesting. The first reports of the drug shrinking tumours will be the first validation but the data doesn't really start to become meaningful until you start to talk about ORR etc. Even at that stage important aspects like duration of response will be missing. THTX's trial is different to Sutro in one respect that they are immediately going after multiple indications, whereas Sutro started just in Ovarian, that might mean it initially takes longer for THTX to accumulate enough data in one particular indication to get meaning for how the drug stacks up against other drugs but if it shows activity across several indications then we get a different sort of validation about the drugs versatility.

https://www.sutrobio.com/sutro-biopharma-announces-encouraging-interim-phase-1-clinical-data-for-a-dose-escalation-study-of-stro-002-antibody-drug-conjugate-in-ovarian-cancer/

I think after that you probably keep getting more reports but I think it's late 2020/early 2021 before they have what looks like a semi-complete Ph1 dataset (still ongoing though) which includes some duration info and which they used to initiate the Ph2 expansion. I think overall that look like a reasonable timetable.

So from initiation

6-9 months to get the first hint of a signal (they'll have it internally before that)
12-15 months to get the first Ph1 part 2 data
24 months to get to Ph2 although at that point they should start initiating trials by individual indications so if an indication in Ph1 part 2 enrols particularly quickly then maybe that can move to expanded enrolment quicker. In the early phases of cancer trials it looks like one phase rolls into another fairly rapidly and is just about expanding enrolment. Assuming good supporting data they can expand to 30+ patients fairly seamlessly.

As always it's going to depend on what the data looks like and how rapid it enrols. At least two of the docs in THTX's trial are experimental drug Phase 1 specialists so hopefully enrolment happens rapidly.



 

SPCEO1 wrote: Qwerty, you and JFM both know the science better than I do, obviously, but I do have some questions for you. You indicated I was too aggressive but then seemed to agree with what I was saying when you disagreed with JFM - am I missing something there? Do you agree or disagree with the possibility we may get some feedback about the pahse I trial from the dosing portion of the trial? Or are you saying I am correctly expecting them to give us some insight into the trial early but my timing on how early is too aggressive? Let's say the dose escalation study starts in mid-March. Three weeks later, in early April, the first patient is completed. I assume they do not move forward until there is no side-effects in the first patient in that three week period - do they typically wait longer than the three weeks before starting the next higher dose on the second patient? On the secnd patient, they will be done by the end of April. Then they will start the third patient, who will complete in late May. Are those assumptions correct? On any tumor response, how long should we expect to wait before TH can say anything definitive on that? 

On AACR, preclinical results may not move the needle much for scientists but it there is no denying that last year's presentation on VM moved investors, at least temporarily. That may have been bubble related, but the stock did trade an astronimical 7 million shares that day and closed 20% higher. So, that AACR data clearly had at least a short term impact on investors.
 

qwerty22 wrote:

SPCEO I think you are getting aggressive on your cancer expectations, from what you've written on timetables it looks optimistic. I disagree with Jfm I think they will announce efficacy signals as they appear. It seems to be how oncology proceeds. The fact that the regulatory process is more fluid, Ph2 can rapidly develop out of a Ph1 signal, makes these material facts so there's a real need to share. Not just that the high risk nature of cancer programs makes sharing data essential for the market.

Jfm is right about the AACR data it really shouldn't move the story along much (that requires dosing patients) but I guess if it coincides with dosing the first patients then it might get attention from the market. After that I think we are only talking about "signals" from the Ph1 trial, efficacy and safety, hopefully both bullish. To know how this drug might fit in the wider treatment landscape is going to require expansion in whichever indications they choose to go after. Assuming positive data then they move to a pivotal, registrational trial. When the data is good these programs can develop rapidly, with more borderline data expect the usual slow progress of drug development.

I think at this stage we are talking signals in the next 6-9 months, I don't think those signals answer every important question so don't unlock all the potential value of the program, but that's something to argue about later in 2021.
 

 

jfm1330 wrote: I was talking about meaningful data. AACR we already know what it will be, good pre-clinical data in other cancers than those already published. On the clinical trial in oncology, I doubt they will rush publicly at the first early sign of efficacy, if it happens, in the dose escalation phase. They are likely to wait for data with the therapeutic dose. So it is likely to go to the fall. Clear protocol and timeline in NASH could help a bit, not much. News that EMA is on board with the final protocol could help a little more.

 

 

SPCEO1 wrote: It is certainly frustrating but I do not agree that they will not have any data to share before the Summer or Fall. Whatever issues remain outstanding with the FDA on NASH could be resolved well before that, removing any remaining uncertainty from skeptics on that front. On cancer, they are targetting speaking again at the AACR conference which is being held from April 9-14. They have laready signalled they have interesting things to say there (see th Novemebr press release on cancer) and the last time they spoke at this confernce, the stock traded 7 million shares in a day and jumped about 20%. Additionally, the phase I is scheduled to start sometime in March and it is an open label trial. If they are seeing something interesting happening, they can share that at any time. So, by May, they will be on their third dose escalation patient and perhaps they would share that they have yet to find their maximum tolerable dose and that the first two patients have seen their tumors begin to shrink.  

jfm1330 wrote: I understand your frustration with the RBC analyst, but the fact is that now he is no longer alone in his skeptic view of Thera. The management did not recognized that view in doing the financing, they recognized it was the general view of the market and made the financing to mitigate the financial risks. They know they won't have meaningful data to share before the summer or even the fall. It is a frustrating situation. I agree. But that's the reality and reality is very stubborn.

SPCEO1 wrote: It is one thing for RBC to have a heavily negative slant on every aspect of TH but it is quite another for the company to effectively confirm those negative views by doing an offering that put no value at all on their pipeline. The company did a lot of good things to put a very intriguing pipeline in place for very little shareholder funds expended but they fell flat on their face when trying to convince a hostile analyst like RBC that he needed to cheer up a bit and look at TH's propsects in a more balanced way. And it cost us dearly. I have no idea how much effort went into trying to bring Abrahms around to see things with even a tinge of optimism, but those efforts clearly failed. 

What happened with RBC is very, very unusual. RBC was granted the convert deal, RBC's analyst pitched the convert to his clients, then he takes a long time to write a report and when he does, he undermines (accurately as it turns out) the story he sold to his clients when he was pitching the convert deal. Then he kept his foot on the brake with TH throughout the entire time he covered it. Finally, he ceases coverage, maybe at the request of TH, who Iam sure, are really tired of his lopsided approach. This kind of thing just does not usually happen. But, of course, it happened to TH!

jfm1330 wrote: In a nutshell you have it. You wonder why the were forced into the last financing? You have it there. To agree or not is something else, but you have the widespread view in the market.

scarlet1967 wrote:

Theratechnologies Inc.

Discontinuing Research Coverage

Our view:

We are discontinuing research coverage of THTX due to reallocation of

analyst resources. Our final rating is Sector Perform with a final price target

of $2.00.

Investment summary

Our final rating on the stock is Sector Perform, and our final price target

is $2.00 / share.

Our view has been that sales of Trogarzo in HIV and Egrifta in lipodystrophy

provide stable cash flows to fund operations and additional pipeline

opportunities for the company, such as the upcoming NASH trial and

promising sortilin oncology program, and that recent commercial efforts

have yielded improvements. However, our view has been that the

current share price accurately balances unknowns about the long-term

competitiveness of Trogarzo, potential patent cliffs for Egrifta, high-risk

nature and unclear regulatory path for NASH, and early stage of the

oncology portfolio.