RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Canaccord Warming Back Up to THTX?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 anyway over the past year (bad timelines on the phase 1a, Europe withdrawal, NASH delays). They also don't get a lot of basic,simple things right when it comes to IR, such as how they have always mishandled guidance. If TH-1902 turns out to be as effective as docetaxel, or more effective, and also safer so it can be given longer, then these fixable flaws will only hold the stock back a little. But I am in favor of optimization of the opportunity they have, so I would like things to move in a better direction as I have made plain for a long time. TH needs to get over their past failures, not overreact to them and move forward on the IR front by adopting a more sensible and open approach. I have done my part by posting here what I heard in my private meetings with them. They could do their part by simply bypassing me and going direct to all investors. Just do it! Share the full story with everyone. Christian is very good at explaining the science and answering investor questions - get him out in front of investors from time to time. He will build some investor credibility for TH!
SPCEO1 wrote: 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 Soleus voted in favor as well - had they not, she may not have been re-elected.
Alll that being said, TH is up this week while the XBI is down double digits for the week. So, if the weak effort the company is putting forth on marketing the stock was able to achieve that kind of outperformance this week, what would a good effort result in?
stockman75 wrote: Wonder if they are proud of the stock price and lack of confidence the market has in their company?
SPCEO1 wrote: 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 cost to it and it was a really big cost when the bubble was still bubbling. Right now, the cost is less because the sector has been devastated by the bubble's burst and it may not have made much of a difference evenif they acted like CYDY, which none of us would be happy about either.
scarlet1967 wrote: 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 investing world the possibility of financial prospects does matter. CYDY sold their bogus news so at some point their market cap was at $10 billions THTX on the other hand really is doing very pour job on thar front.
qwerty22 wrote: 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 wrote: 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 wrote: 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't prompting this fact. Well because it isn't a fact. It might be an aspiration based solely on hypotheticals.
Why it was ever said we probably will never know. It seems to me to be interesting as a piece of gossip and minor as an investable fact.
scarlet1967 wrote: 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 patients in several clinics in the US and Europe why not mentioning it on the PR? To me thats all good news so far but this low profile strategy has nothing to do with lack of professionalism in my opinion it is lack of interest in being transparent. The trial took longer than many anticipated for understandable reasons so it has been a long wait so their investors deserve much more than MTD is 300mg/m2 wait another year we keep you posted at the end of it. The company needs to feed their investors with much more than that. My understanding is based on those private calls the trial is progressing well I want the company to professionally market the news.
qwerty22 wrote: 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 response, if you don't then you don't. One confirmed partial response based on RECIST definitions IS proof of efficacy and I think the analysts will handle it as such. It doesn't answer all your questions but it gets us to the next step. For example the most pressing next question will be can the drug hit it's targets for 1b. It might tell you it has a chance but it's not a strong guide. What I think it does is allow you to move on from where we are now which is not knowing if this drug has ANY anti-tumour activity in patients to allow us and the analyst to start contemplating the next set of questions.
To me it's a very good sign that the company can differentiate between what is a widely accepted measure of what constitutes a solid efficacy signal and what is a hint at something good that might keep you enthused. Hints don't deserve press releases and when they start selling hints that's a red flag. To bring up an old friend this is exactly what I think cydy did in their cancer program. So not saying anything while all you have is hints is a mark of professionalism in my book. Presumably when they hit something that is defined by accepted industry standards like RECIST then they will tell us. To me these are the measures you judge them by. Any off the cuff remarks in a pre-meeting conversation are interesting to they don't mean a whole bunch yet.
SPCEO1 wrote: 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 they have two scans, six weeks apart showing tumor shrinkage.
I don't know how they handle the issue of multiple tumors as given the patients they are dealing with that is certainly an issue. I d oubt they have very many "clean" and easy tumor situations they are dealing with in these very ill patients and there must be some protocol for handling that. For example, with my dream of two of the three 300mg patients being ovarian cancer patients - even if this was so, comparing the results of TH-1902 on these heavily treated patients to new ovarian cancer patients just starting docetaxel as their first ever treatment isn't a fair fight. I am not sure how adjustments are made for such complications, or if any are even made. If anyone knows, please post how these things are handled.
jfm1330 wrote: 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.
That being said, sometimes it can be complicated. Reality and RECIST criterias are two different things. Somebody I know has a neuroendocrine cancer metastasized in the liver and in the bones. The primary tumor (small bowel) was surgically removed. So he only has metastatic cancer in his body, mainly in the liver, but with small tumors in the bones. After treatment his doctor told him that the biggest tumor in the liver shrinked by 30%, but it was harder to say for all the other smaller tumors. So probably a case like that would not qualified as a partial response per RECIST criterias, but on the other hand there is clearly efficacy. Since treatment, his cancer is stable, that is for 18 months now. So with cancer, doctors can see clear efficacy for them with their experience, but maybe a company cannot report it it as efficacy per strict scientific criterias. So maybe Thera are dealing with cases like that in advanced metastatic cancers.
SPCEO1 wrote: 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.