Theratechnologies Inc T.TH

Examples of efficacy from dose escalation studies

[Wino115]

Just as an example, here's what analyst says about two dose escalation trials in Phase 1 for Prelude Therapeutics.  The drug and cancers are different than what THTX is going after, but it does show that if they are doing scans around tumors, they may have data (even n=1 type data) that analysts are interested in.  Here's how Barclays looked at these two recent dose escalation data points in regards to valuation and de-risking.  Notice the number of responses isn't high.  They look at one anecdotal complete reponse in ovarian and brain cancer and use that to assess a higher probability of success for this trial

TRIAL 1: 
On clinical efficacy for PRT543, early Prelude responses in solid and hematologic tumor types help validate the approach for PRMT5 inhibition: 1) In solid tumors, initial Phase 1 data for PRT543 shows activity in HRD+ ovarian cancer, including one rapid and durable CR from first scan out to 9 months in a highly advanced patient. In 13 solid tumor patients, as of Sept 2020, Prelude has shown 1 CR (HRD+ ovarian cancer), 4 SDs (including 1 HRD+ ovarian), 4 PDs, and 4 awaiting assessment, and 2) In hematologic malignancies, of nine MF patients, there was an 11% (1/9) ORR and 89% (8/9) SDs. Of total evaluable hematologic patients (nine MF and two MDS), 73% (8/11) achieved SD.

 The fast response rate in ovarian, early in dose escalation is encouraging: The ovarian CR was at first scan with a drop in CA-125 to 2.6 U/mL (from 37.8 at baseline) and the second scan (eight weeks later) confirmed the CR with a final CA-125 of 4.6 U/mL. A third scan (at 24 weeks or ~six months) demonstrated continued CR and CA- 125 fell to 3.3 U/mL. The HRD+ ovarian patient with a CR has received nine months of therapy and remains a CR as of 12/16/20.

TRIAL 2:  Here's for their brain cancer trial:

For Prelude’s oral brain-penetrant PRMT5 inhibitor, Phase 1 dose escalation data shows 17% (1/6) PR in GBM – though small numbers, the response has deepened and confirmed, which is encouraging for early dose escalation data: Of six GBM patients reported so far, one refractory GBM patient had a PR with -66% reduction initially, with a subsequently reduction to -77% from baseline by week 18, confirming the PR. The GBM patient has received five months of therapy and remains in PR as of 12/16/20. We note that, overall, Phase 1 dose escalation data has been reported from 17 patients (10 solid tumors, 6 GBM, 1 pending diagnosis) of PRT811.

SO the analysts conclusion on these two dose escalation data points of 1 deep response from a patient is that it de-risks the trial:

In summary, at AACR-NCI-EORTC (Oct. 7-10), for Prelude’s PRMT5 inhibitors in Phase 1 dose escalation, we expect to see additional responses — up from 1 CR with PRT543 in ovarian cancer and 1 PR with PRT811 in GBM, as well as a favourable safety profile.

Upside/downside: We assign a 65% likelihood to positive results, potentially driving the stock up +15%, while negative results could drive the stock down -10%. For PRT811 in GBM, we project peak probability-adjusted sales of ~$685mn by 2028, or $10 of our $80 price target.

So THTX should look at these competitor releases and feel comfortable given as much data as they can around the dose escalation so that the concept and MOA is understood, the safety is understood and the way the drug may develop in the next phases may help.  They shouldn't be afraid to talk about scans and partial responses of even 1 if it's deep.  All this data, whatever it is, helps to understand where it stands and how we should adjust our left and right tails.  I hope they read what other companies do and how analysts may look at these things.

[realitycheck4u]

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[SPCEO1]

They likely are not giving any notable trial data yet because they are aiming at another fundraising at some point soon and are trying to hold as much good info as they can for that. Either there is no good info to report (which seems unlikely) or they are curating the info for a release at an optimal time in conjunction with a share sale. That is my best guess as to why they have taken the info

[palinc2000]

I would expect if they had market moving ''good" info  they would release it and not put a lid on it for months.....

[SPCEO1]

Look how quickly you have forgotten what they did last year! Remember the press release with the news of the FDA approval of both the NASH phase III and cancer trials along with the 25% growth rate expectation for the legacy drug sales??? One of the drug trial approvals came before Christmas, the other after Christmas yet the company sat on both for a while and then added the fabrication about

[qwerty22]

I think what they have done with the timelines is they have given themselves until the end of the year for the data from this small number of patients to develop. If the drug is efficacious and they've picked up the right patients who can respond then what they should be seeing from late summer are efficacy signals emerging. Each new scan has the potential to add something important to the

[palinc2000]

Spceo wrote " Or they are just speking in an optimisitc manner that intentionally is creating a perception of success in the trial when no success has yet been seen? While they have shown a willingness to distort the truth in the past, I am hoping they learned from those mistakes. "  I must have missed the optimism about clinical results in Oncology.All I heard is optimism on&

[SPCEO1]

Below is a more comprehensive quote from my post which I believe better characterizes what I was saying than just the portion you quoted. Do you think that the way Paul has characterized the cancer phase 1a so far can't be described as optimistic? Granted he has given us no actual data on the phase 1a but he has clearly built expectations of a positive result with pretty effusive comments

[qwerty22]

I'm not sure it's a question of him being truthful or not. Everything Paul is doing is normal. He has to believe in the tech and when he's talking about the potential inevitably he's going to focus on the positives. When he's projecting forward he has to talk about the many places the program might go. I think it's also totally normal not to talk about what's happening

[palinc2000]

There has not been a single quote  from Paul in which he hints that the Phase 1 will be successful.This small trial the first using Thera s PDC in humans is ongoing ,,Even though it is an open label trial I dont think Paul can determine the outcome be it negative or positive. He might feel optimistic and he should ,,otherwise why undertake a Clinical Trial if you dont think it has a chance of

[SPCEO1]

I think you are trying to strain out a knat here. I agree that Paul has never said the phase 1 will be successful. But he sure has made many comments that raised expectations regarding TH-1902 generally. And I do think at this point that the company has sufficient information to know quite a bit about how the trial is going. As Wino showed wit Prelude, other companies do share information about

[palinc2000]

He has raised your expectations maybe but obviously he has not  raised expectations,I hope your interpretation of his comments prove to be factual

[SPCEO1]

The stock is up 50% so far in 2021 and I think it is obvious that the reason for that are the expectations for cancer. That would not have happened without Paul being part of the efforts to highlight expectations. Please don't think I believe that I think Paul has done something wrong in raising expectations. If he did so because he is aware of more about the success of the trial than we are

[Wino115]

Wouldn't we all agree that there's probably about $1.25-$1.50 or so for option value on the oncology platform in the share at this point? That's based on the market (and the marginal investor) assessing whatever positive facts they've figured out from the company and the scientific literature about what is known.  You have to think that option is worth more or you'd sell

[palinc2000]

I dont think the SP includes anything close to yoyr 1.25-1.50 ....That would leave a  zero or close to zero for Nash....  

[Wino115]

I agree with you that this is all debatable.  But just to recall my analysis, I didn't figure out that value based on the whole business and a sum of the parts valuation like a lot of the analysts do.  So I didn't value the HIV biz, NASH and then say the rest was option value which I think is how you're looking at it here. What I did was take actual revenue estimates from an

[SPCEO1]

First, let me say t hat  I think Palin is just flat out wrong that the market is giving value for NASH. The only analyst who has incorporated anything into their model for NASH is Mackie and they have very little influence over the stock price. The NASH KOL generated nothing for the stock. THTX's NASH entry is just not getting any respect from investors, largely because of t he backdoor

[stephanedodier]

Hi all, I like this board and the opinions. I think we do a good job together following this stock. Someone told me long time ago that the market was never wrong. The value given to a stock reflect the perceived value from the market.  I am long, and full of hope. I have no intention to sell any for the moment and I will give THTX 12 months, not one more. GLTA

[canadapiet]

Their past history!!! They are a company with 2 products on the market that do NOT generate enough money to make the company profitable! Just recently, they became a R&D company with those 2 other possibilities.  One with the old Egrifta, years on the market and just now research for NASH??, and a molecule from the deal with Katana, very early in the proces!  So it is obvious the

[realitycheck4u]

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[Wino115]

I would also point out that some of what may come from a dose escalation and even the extension trial that is perceived as "negative" is something that would not derail the SORT1 program completely. For instance, it they see it really only works best in late stage, or in mTNBC or where SORT1 was expressed at a super high level, then that's knowledge to ascertain the conditions the

[Wino115]

Edit: "I have to believe all those scientific studies since they were done in HUMANS (not studies)."

[scarlet1967]

"They've already mentioned immunotherapy drugs," I think that's very interesting as paul said they will be looking at immunology and their PDC to see there is a synergy. 

[qwerty22]

It's worth looking at how much interest that early ovarian data from Sept 2020 caused. After the data release they announced their IPO. This was initially priced at $18 to raise $150 mil, they ended up raising $181 mil. The SP shot up after that to as high as $88 over the rest of 2020 and they ended up with a 2nd financing in Jan 2021 at $60. Pretty good for 1 CR

[Wino115]

We can only hope!!!  I suppose it does show you what you guys have pointed out many times -- any decent signals around Proof of Concept are huge at this early stage in de-risking future trial risks. That 3% overall approval rate for oncology trials moves significantly.  That's the kind of reaction I would hope to see.

[qwerty22]

It's worth looking at how much interest that early ovarian data from Sept 2020 caused. After the data release they announced their IPO. This was initially priced at $18 to raise $150 mil, they ended up raising $181 mil. The SP shot up after that to as high as $88 over the rest of 2020 and they ended up with a 2nd financing in Jan 2021 at $60. Pretty good for 1 CR!  

[SPCEO1]

Take a look at the brokers that were involved in those stock offerings: Goldman Sachs, Morgan Stanley, BOA/ML and Barclays. That is a big reason why they got great stock performance. THTX, if they do indeed have something in cancer that could transform the way the disease is treated and if it truly is a platform that could have broad application, they had better be talking to these same brokers

[SPCEO1]

Prelude also has a market cap of about $1.5 billion with $343  million in cash on the balance sheet. That c ash should last them until 2023. They have no other programs (such as THTX's NASH) and no approved drugs. Just dose escalation studies on their cancer compounds exactly like THTX. Anyone else tired of seeing Taimed, CYDY, AKRO, IVA and Prelude (among many others) all selling at

[scarlet1967]

This has been ongoing problem with THTX, same board with the same way of thinking now Paul a sale man tries to make a change but ultimately the board is running the show. Their strategy to create value by haunting analysts for years hasn't worked/changed.Your friend in few seconds was more successful to move the stock than THTX's efforts in the last few years. Why? because he had a broad

[CreatingApe]

Mr Spceo, I think what should be done if they continue to fail is exactly what should have been done last time they screwed us on an offering... we should vote off a couple of the useless board members getting paid to sit around some meetings and make poor decisions on our behalf. We have that power, and this time around ( if things are poorly managed again in the next few months leading to

[qwerty22]

I agree that's strong market backing. You should have a conversation with Paul. Check his aspirations around this important issue are as high as his aspirations for the clinical program. Ask if they've done the ground work with these bigger guys.   Who is meant to be the lead in this process? Dubuc? Does he have the imagination or skills to land these types of deals? It'

[Wino115]

If no one in management can start those conversations with bulge bracket firms post solid data, that's where you would normally lean on Board members for proper introductions.  Other than Mr. Molson, I'm not sure there's someone there with a 100% lock on getting numerous "right" pepole on a call or meeting.  If not, use your large institutional investors for laying

[qwerty22]

Seems like without signs and signals on any front (clinical, financial, investor relations) you can take your pick of any one of them you think are going to give us pain. Probably should go off grid until the end of the year.