RE:RE:RE:RE:RE:Quick Summary We are all tired of the wait...in fact, way past tired and well on to the end of our rope! First, I'm a little disappointed all the questions thrown up here were not thrown over to management -or at least they weren't asked. The question referred to by JFM was mine and I was hoping that the way I worded it would allow them to talk about what they've seen without having to give any actual human data. There was a general answer which was positive, but I would have also preferred a few more specifics like --we've seen this repeated, this stronger, this weaker, doing what we thought, not doing what we thought here, etc... Nevertheless, you all should have asked your tough questions on the timeline, why believe it now, etc... Maybe send them off to Dubuc and you'll get answers from them.
I had also thought we were all passed thinking you'd see actual efficacy and it was more what parts of the data they've collected can inform us around the conceptual parts of the program working in humans as they worked in mice. It may not be efficacy, but we may be able to conclude facts around target hit vs. target miss, internalization vs. free float chemo, what side effects to look out for with multiple cycles, etc...
The trial protocal does say they will have all the PK/PD data and that's part of the endpoint data discussed. I think it's secondary if there was any ability to do useful scans and RECIST data, although that is listed in the trial protocol. Getting anything more than the dose, safety data around various SAEs and some of the pharmaco data is the baseline of what they should release once they are done. They have to release it and would likely see the investigators publish it at some point. So I think we will see data on those three aspects (dose, safety data, PK/PD) and maybe even some of the sortilin correlation data if it means anything. It will help us think about the issues around the drug, but efficacy was more or less always going to come from the basket trial where they'd have the right cancer types, have measured sortilin expression data, have enough patients to make a meaningful conclusion, and they don't have to be at the end of their life (I think the inclusion may just be something like had 3+ prior lines). There may be additional data around how they did with combating metastices, etc...
I think if you're frustrated, you should definitely ask those questions at the annual since you just lost your chance, and perhaps we shouldn't look for data they weren't 100% sure they'd even be able to collect.
I'm definitely in the "more confident" side of the equation listening to today's presentation and absorbing some of what they said. But I completely agree that they need to provide far more factual human data to investors in order for us to understand where the program is --but I think we'll get some of that shortly. Given that the share doesn't really incorporate even the option value of the oncology program in the price at this point, there's no harm for them in doing so and there can only be upside as I see it. Information is needed in the market to clarify the massive uncertainty the last 12 months of trial has caused and they need to discuss everything about the 1a once it's done and be super clear on 1b and why it will ramp as they believe.
stockman75 wrote: Good post MAC7824. I agree the confidence/positivity is normal for a board and management so we can't read too much into what they say. Even if things are looking a little bleak (and I don't think reality is bleak with oncology) management still wants to believe that the good news is around the corner just like us investors. They too will have confirmation bias. Christian is great at what he does. He has poured a ton into the program. Do you think even if he were seeing things go a bit off course in the trial he would just accept it? Or would he rather look back at his clinical data for reassurance? Could that be what is going on? Maybe I don't know it is all speculation but there are many narratives we can spin and until we see the hard convincing data in humans that is what it all is... just speculation.
Personally I am frustrated with the slowiness and delays. It is hard to sit by and watch our investment just sit and languish without knowing for certain what is going on behind the curtains and likely Thera is also trying to understand the data and get true sense of how the drug is working. Again many narritives. It is just too early and things move to slow for us investors who have been patient for a very long time with the company.. and so we wait a bit longer.
MAC7824 wrote: First time poster, long time reader. Invested in THTX (formally THERF) since 2014. I appreciate all of the insight from the posters as it has been very helpful to keep my attention on this company since THTX has done a very poor job of communicating.
I totally agree with this post, JFM. One sense I have gotten from this board is that we have been hopeful for "preliminary signs of efficacy" from Phase 1a for around 6 months now. Around that time, I spent time researching how many other companies going through a Phase 1a with a FDA fast-track designation actually release "preliminary signs of efficacy" for a trial focused on safety, and found it was incredibly rare for a company to do so. Additionally, I do not agree with this board trying to glean bits of truth from management regarding preliminary signs of efficacy, as one of the primary jobs of externally facing employees (CEO, CFO, etc.) of THTX is to act as a salesman of the company. Every company tries to sound optimistic during their earnings calls, and that is their job to do so. I think it is foolish to expect that a company that is new to the oncology scene would be the rare exception to release any signs of efficacy prior to the Phase 1b being totally finished. The wise company would hold off on releasing any data until it is absolutely bullet-proof, and I expect THTX to do that.
Having said that, I am still optimistic that THTX is on-to something in oncology. As I have read on this board previously, there are MANY companies that do not make it passed Phase 1a safety trials in oncology, and I think that should be celebrated. I anticipate there will be a small price bump in the stock price once the Phase 1a PR is sent out. I do not, however, based on today's call, believe that this board should hold out any hope for efficacy data prior to the end of Phase 1b, and anticipate THTX will shift it's tone from focusing on pre-clinical efficacy to potential future avenues now that TH1902 is deemed as safe. I also agree with JFM's point regarding the explanation around repeatedly missing timelines. Based on the evidence we have thus far, what expectation is there that the Phase 1b will not be delayed significantly? My approach to THTX's timelines over the last eight years has been to listen to it, and add at least 3 months (and sometimes 6 months) to each timeline they provide, which has been more in-line with reality.
Thank you all for the posts and I will go back to just reading now!