Theratechnologies Inc T.TH

Financial and others

[Garp1]

https://www.gurufocus.com/news/1476202/theratechnologies-reports-financial-results-for-the-second-quarter-of-fiscal-2021-and-provides-update-on-its-planned-phase-3-clinical-trial-in-nash

[palinc2000]

Disappointing sales and change of plans im Nash -start of Phase 3 Trial delayed and THTX looking for a partner in Nash due to higher Phase 3 costs

[Wino115]

Most important near term value driver is the statement that SORT1 progressing as planned and we get safety AND efficacy data in 4Qtr confirmed still.  NASH news is a trade off. EMA now 100% onboard, but adds more trial patients. As was speculated here, wait to see how cancer develops, take some time to know what's ahead of you, and engage a partner if you can get the right one that adds

[palinc2000]

Not  clear to me if the search for a partner has started or is in the process of being initiated... If not started yet why did they wait?

[scarlet1967]

It seems like it has started: "An external U.S.-based biopharma advisory firm has been retained to assist in identifying a potential partner."

[palinc2000]

I meant just recently like a few days ago or a moth or more

[palinc2000]

Contrary to my expectations only 197000 warrants were exercised,,,,,

[scarlet1967]

On oncology reading between lines the trial is progressing well. On NASH they  have completed the negotiations with both agencies and have EMA onboard. They need now to do an interim futility analysis on 400 of total 1100 patients for 18 months (75 to 100 HIV), post approval will include additional 1800 patients. So my take is the EMA wanted that interim analysis included in the trial process

[palinc2000]

I guess end of May was still in pandemic country which could explain sales,,,, Could the search for partners have been delayed till the interim futility analysis ( 400 patients) If there is no efficacy then the trial would presumably be stopped and t he costs till then would be lower than was originally expected,,,,

[scarlet1967]

They said they are exploring their options one would be to look for a partner, I think it's either they go alone but most likely with a partner and if so it seems like as it says the trial might get delayed! they won't start it including the futility analysis (which is part of overall phase 3 trial) until they find that partner which could be a company both in the US and Europe. My take is

[Wino115]

Maybe LSA is doing the banking too.  Securing the EMA blessing is also important for parthership potential.  We know there is some similar science with semaglutide/Novo Nordisk and perhaps someone approaching it with an anti-fibrotic. It may or may not happen.  On the plus side, you have safety out of the way, which has been a huge bug-bear for the trials.  So they're half

[qwerty22]

The search for a partner is just a positive spin on the fact that the program is parked, shelved, whatever you want to call it. Until something different happens. We really are in Hail Mary territory if it's relying on finding a partner, basically they can't get the market to finance this. I think you should think of this program as inactive until we get news to the contrary. 

[Wino115]

All fair points.  I don't think it's inactive though, that's strong words. PL mentioned they've drawn up a strategic roadmap for all options and plan to be a NASH company one way or the other.  As you say, one way could be small trial but I don't think they would do that given timing. They are still an early entrant, so don't underestimate that option value

[scarlet1967]

To claim the NASH is shelved or inactive is not correct, they have a ready to go program both in Europe and US which took almost two years to finalize as per partnership these deals will take long time to finalize, it won't happen overnight as per CEO they are currently talking to interested partners again as per CEO they certainly won't give it up absent suitable partners. 

[qwerty22]

There is NO PLAN to dose patients. You can't have a clinical program without patients. It's no longer a clinical program it's an asset sale.

[scarlet1967]

It's not a clinical program until it is, it's definitely an operational program part of their overall business. What they are doing  with that program is not shelving it but exploring various options. NASH is a massive market many companies starting from preclinical to various stages of trials spending huge amounts of funds chasing those financial opportunities. Now after two years of

[SPCEO1]

Qwerty, your very harsh view on NASH could be spot on but I think it is not sensible to consider different outcomes too. But, I am not too put out by this development because it is just another hint that the cancer trial is going well. If cancer looked like it was flopping, I suspect they would be less likely to partner in NASH. Cancer is the main driver short term anyway. We got only hood hints

[qwerty22]

This is simple and complicated. For this to be a clinical program they would have to have a plan to dose patients, biotech 101. They have no plan to dose patients, it's no longer a clinical program. That is shelved, it might get re-activated but it's shelved now. That seems pretty clear to me now. They aren't going to unlock value that way. What they've been signalling since the

[jeffm34]

It's a credibility issue.  The company was quite adamant they were dosing patients in Q3.  So what changed in their eyes?  Did they finally just realize what everyone else knew?  Did they wrongly assume they would have found a partner by now? Did they think they could just do another round of financing to fund it on their own?  They claimed it was the 25% increase in

[SABBOBCAT]

To me, this is a huge blow to PL's credibility. It was just weeks ago that he was messaging a firm start to dosing be the end of Q3, now dosing isn't on the radar. That does not sit well with me and even makes me start to question the oncology results. Mr Market has this one dialed in... Show me the results, because your talk (and/or lack thereof) is worthless.

[jeffm34]

The apparent lack of good advice and guidance coming from the board room on many fronts is glaring.  I don't believe they have what's needed to make this a successful company.  

[qwerty22]

There are different ways to look at this. I don't think internals fully explain all this. The NASH drug development environment looks terrible atm. The speed with which NGM pulled the plug on their program suggests they couldn't run away from the risk in NASH fast enough. I think that external risk and market confusion around NASH is playing a part in this decision. But that is something

[scarlet1967]

They got the EMA onboard by altering the original trial design which will cost more, the partnership idea was discussed during the chat with concord so it's not a u-turn as some suggested, the added cost might just tip it over but again they "certainly " won't give it up absent partners, why should they? Yes their oncology program can be approved but that won't happen

[canadapiet]

When i talked to mrs. Gibson and suggested the possibility of partnering,  she said it would be a pitty to partner and give away "the bulk of profits"... ...????!!!!! They wanted to keep it inhouse and go it alone!   scarlet1967 - (7/15/2021 12:29:16 PM)  RE:RE:RE:RE:RE:RE:RE:RE:Financial and others They got the EMA onboard by altering the original trial

[scarlet1967]

Yes that was then and their plan has changed, again the partnership idea isn't new as it was even mentioned few months ago they have reassessed and now they are open to it from the beginning of the process which is a good thing, one has to evaluate and reevaluate business decisions based on the educated potential  best possible outcome.Again they are not ruling out anything at the moment,

[canadapiet]

When you declare the go alone strategy a few months back and now you tell the investor community you search a partner, it is a sign of weakness!!!!  It will be like that horrible O O ! Nobody is waiting to be the partner, so they will get AGAIN a low ball partnership......!!!! Bad management!  scarlet1967 - (7/15/2021 1:14:55 PM)  RE:RE:RE:RE:RE:RE:RE:RE:RE:RE

[bfw]

Which company has worse management? THTX or GLPG? The latter had hihgly touted management but has sunk like the provervial rock. Down about 75% since its peak. Ouch! bfw

[canadapiet]

Hahaha,  bad comparisan mister bfw!!!  GLPG was "screwed" by the FDA with their RA Filgotinib. It is approved in Europe and Japan, so give me the reason why not in the US ! Oh, don't, i know allready, ABBV was in the room .............! TH lied in the past and with new management it is more of the same! Glad i sold my 9.500 shares for 4,80 CAD !  Mister P L says

[bfw]

Hmm...so GLPG's inferior stock performance can be blamed on the FDA ;) Oh well, as long as you are happy being down about 70% in a year or back to 5 year lows. For reference, TH was $2.55 5 years ago. I'm not happy with that performance either but at least it is up on a 5 year basis. Perhaps time to give Paul a chance to execute. bfw

[canadapiet]

I am not happy, especially not for the patients! First, blaming the FDA for sure. Must think about DDS(Labopharm) a long time ago. They had 2 good trials fase 3 but not good enough for the FDA, so they had to do another trial. DDS was  finished. And big pharma was satisfied!  So is ABBV satisfied now with their "humira" etc Second, i wrote times ago that the bulk af my GLPG

[canadapiet]

Forgot point 4  canadapiet - (7/16/2021 10:30:48 AM)  RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Financial and others I am not happy, especially not for the patients! First, blaming the FDA for sure. Must think about DDS(Labopharm) a long time ago. They had 2 good trials fase 3 but not good enough for the FDA, so they had

[qwerty22]

Paul can say what he wants about the future of NASH because like the rest of us he doesn't have a Crystal Ball, he just needs to stay vague and plausible. What we actually know is they won't be dosing patients until something changes. That might be the right commercial decision given the circumstances but it doesn't help move the stock. Milestones matter and we just got a less than

[Wino115]

Have to say QWERTY, your questioning and head-scratching around the program was good objective analysis and ultimately right.  I wonder if they would have gone solo with just the FDA and no additional costs?  The statements make it seem like maybe.  But I think they still would have as they've seen their plate fill up with oncology very rapidly.  EMA harmonization was

[SPCEO1]

While today's news does give Qwerty's view additional credence, I am not yet ready to throw the towel in on NASH as he is. Let's give management some time to see if they can come up with something worthwhile. Paul put as nice a bow on this as he could to make it look pretty but I don't get the sense they are entering this situation from a position of strength. But, who knows, maybe

[scarlet1967]

They have the dosing and Tesamorelin is safe, how many drugs have been pulled from market during post approval phase or behind due to safety? Today's market reaction imo if based on NASH news was not warranted as there were zero credit built in the valuation for the program. The fact that EMA is onboard and that was a big issue for many is positive news , the fact that harmonized protocol is

[jfm1330]

Today's news on NASH has nothing to do with the validity of using tesamorelin to treat it. The rationale behind it remains the same and it is still scientifically sound. What changed is that the number of patients they will need to enroll is mch higer than expected, and experience from other companies showed how hard it is to run a NASH trial that is robust and reliable. There is an inherent

[qwerty22]

I realize I'm being super negative.  To me it's really about the circumstance in which things are happening. Grinspoon's data looks fantastic in supporting a final exploratory trial to get that none futility info. In a straight Ph3 the holes are all I see and a lot of the positivity is lost. The data hasn't changed but what you are asking it to do has. The same is true

[palinc2000]

Found this in the first page of the MD&A .....OF THE Second Quarter Does this make sense ? In addition to the risks inherent to the conduct of clinical trials, there exist risks that the FDA will not approve tesamorelin for the treatment of NASH without the Company having substantial evidence and data from the conduct of Phase 2 clinical trials evaluating tesamorelin for the treatment of NASH

[Wino115]

I think some of that is CYA and some of that reflects the Ocaliva situation and the somewhat fluid nature of endpoints, biopsy readings, etc.. with NASH and the regulators.  You need to leave a lot of wiggle room since it's still all developing. The regulators have agreed to their trial plan according to today's discussion.  So that is all they can go on.

[scarlet1967]

Well the NASH is on hold is shelved is inactive! The Trogarzo market is much smaller as the docts only prescribe it when patients' current regime fails, lipo is cosmetic so the only this company has a "preclinical" oncology program. Is that all it takes to stay invested in THTX? It's good to remember they got the letter May proceed from FDA based on 900 patients in phase 3 and

[1998novl]

Well said Scarlett you nailed it. The negativity on this board is mind boggling at times. 

[Bucknelly21]

It is but people are tired of these antics from Thtx and to be honest I am too about to sell a large position 

[qwerty22]

Their internal clinical program is shelved, yesterday they told you they won't be dosing patients. That path for growing the asset has gone. It's not that difficult. I get you want to hang on to Paul's words but he told you what the actions will be and you seem to be ignoring. It's now an asset sale only. That fact means the opportunities for moving this program forward have

[PinnacleX]

This post has been removed in accordance with Community Policy

[PinnacleX]

This post has been removed in accordance with Community Policy

[juniper88]

Maybe.  But if the cancer trial does really well and the market responds accordingly, perhaps financing the NASH trial becomes possible again.

[qwerty22]

You're not getting the important details on NASH. It was never the case the EMA would say a straight "No". You'd only get that with a hazardous safety signal. The EMA would always agree with something. What the company is announcing today is the EMA have agreed to a program that the company finds commercially unviable, the company is not prepared to activate. That's not a

[SABBOBCAT]

I hate to say it, but you're right, the NASH program is done. You don't go out and say your looking for a partner in a quarterly call, you simply go and do it. They hired for a partnership role 8 months ago and there is nothing to show for it. We are dead in the water on NASH