RE:RE:RE:RE:RE:RE:RE:The potential oncology collaboration..I think you've summarized the situation well. I, too, thought we'd see a gradual move up in anticipation. I think the reason we haven't seen that is that the 1a news really just de-risked safety (admittedly a big deal), and hinted at efficacy. We really do need to see more around efficacy to de-risk the most important remaining element prior to moving in to a larger trial. It will provide the necessary reassurance needed. Now, your question still stands --will that do anything for the stock? I think you answer what they (management) does need to spend some strategic time thinking about. It won't be enough just to hit the milestone in this investment environment. They do need to go more on the offensive around putting this program (Sort1) within many analogous oncology development projects (the ADCs, PDCs we've highlighted) so as to get the "idea" of what this is and can do can be more readily understood and put in it's place. Secondly, they need to then start talking about the market size, the revenue potential should their P2/3 succeed. They need to be that "zip-trader" or the "CNBC guy" and push it harder than they have in the past. Above all, and we and they know this, it would really help to get 1 or 2 better known bio/oncology analyst with some following to cover the stock. They can bring a bit of an audience, we can hope, and increase the size of the spigot -- more daily trading, higher demand, etc... But you are right in that the lack of audience means no anticipation around this end of 1b and possible efficacy. In fact, I think a science-based analyst looking at the pre-clinical, invivo and what we did get out of 1a could start to handicap some of the key issues. Certainly after some more data dumps (that they MUST do), the picture may start to appear. It's up to them to strategize on how best to articulate a convincing investment thesis based on that new knowledge around SORT1. Imagine, shortly you may be able to have bullet points like this (completely made up by me and facts can be wrong!): - Our thesis has always been that for advanced metastatic tumors, sortilin is highly over expressed and by using a PDC targeting it, we can within minutes of injection have TH1902 literally gain entry to most tumor cells with a chemo dose 7-10x the normal dose, and drop off it's chemo-bomb to kill the tumor cell. If this is the case, since very few healthy cells nor important body organs overexpress Sortilin, it should exhibit a very tolerable and safe profile despite the large chemo dose. This should allow a safe administration of a high dose over a longer period of time, thus improving efficacy in these patients who have exhausted all other treatments and whom have no current therapy to help them. This was our theory coming out of numerous academic institutions around the world and from our own 4 year of lab work on sortilin. - The previously proven pre-clinical theory has now moved into humans and we've seen conceptual proof around many of these major elements in this Phase 1 trial and look forward to further proving the concept in a larger Phase 2/3 trial for xxxxx cancer patients with no known treatments out there in the marketplace. - Phase 1 proved that the dosage used is safe. We have seen no major SAEs and have had patients on it as long as 30+ weeks with a dose that normally would need to be stopped after 12 weeks or they would risk death. - This occurs because Phase 1 PK/PD data showed roughly 90% of the PDC is internalized within tumor cells rapidly and is not floating free in the body being absorbed by sortilin in other organs. Importantly, TH1902 spares the normally destroyed bone marrow and white blood cells that create the typically therapy-stopping issue of neutropenia and severe infection. Having a patient receive the dose we give, for the time we have seen would normally cause life-threatening issues which we saw none of. These characteristics are novel and important in the field. They have not been replicated by any of the current commercialized ADCs in the oncology field, nor any PDCs that we are aware of. This is the theorized ground-breaking result we foresaw and why the FDA granted us fast-track authorization prior to initiating the Phase 1 trial. - The chemo is being introduced into the tumor as seen by the examples of tumor shrinkage, cancer marker regression and objective responses. We can also speculate, and look to further investigate, the anti-metastatic properties seen and our hypothesized view around TH1902 interrupting the vascular architecture that supports tumor growth. Our pre-clinical work showed both stem cell and vasculogenic mimicry were severely disrupted by TH1902 and theorized by the existence of sortilin being necessary for both vasculature lining and stem cell growth. By overcoming numerous resistance mechanisms that normally would not allow the chemo to kill off these cells, TH1902 is showing an effect. As our journal article last year showed, the cancer stem cell markers such as CD133 and CD44 measured in our various evaluable patient sets did show meaningful decreases on average. This increases our confidence that TH1902 is having an effect directly on CSC and VM. Phase 2 will further inform us of the power of this effect. -Phase 1 has allowed us to confirm many of the key elements around the original conceptual thesis --the drug is highly safe at the recommended dose, it allows a quick internalization of a chemo payload 7-10 times the normal dose, it allows for a much longer period of treatment --thus giving hope to these patients with no option left. Given the responses seen in this list of cancer types, we are moving ahead with FDA approval to immediately initiate Phase 2/3 confirmatory trials shortly. - These market combined represent revenue potential of $xx million annually, with no current therapy offered for refractory, heavily treated population we are testing. Over time, we would expect to other toxins to attach, other possible combinations with our therapy, and using our therapy at an earlier stage given it's safety, efficacy and anti-metastatic properties. The latter characteristic would be important to start earlier with many different cancer types. - As you can see, we have now moved decisively from the lab bench to the clinical bed based on solid success through just one trial phase. We look forward to an active schedule of data releases over the next year as we plan on informing the market around these trials in an expedient and transparent way now that we have reached the hurdle of proof of concept. Given we have definitively shown safety has been established and the fact the toxin being used is a well-known and used generic, we believe future issues should be well understood and further trials will should show consistent results with these Phase 1 results.
PWIB123 wrote: One of the reasons why I was willing to put so much of my capital into this one stock was that I believed there would be multiple press releases, updates, and shareable information as THTX made progress through the various stages of the trials. Not only did management not give us much there, when there are press releases, there's virtually no reaction. So, my mindset has shifted to accept the fact I own a lottery ticket now. It will either work or it won't and the next big piece of news de-risking the unknown around if it is going to work should drive the price up, right? Except that now we are seeing major partnerships with other stocks in an early stage do nothing for that companies stock price. That gives me major pause.
Part of the de-risking for me was the odds that THTX would find lots of positive things to share along the way, regardless of total outcome in the end. For example, if the stock had been increasing along the way on the hopes and expectations of a huge breakthrough drug, and if my stock position was in the green, then if something in the final stages prevented THTX from getting approval or if there was a delay or major setback, that the stock price decline on that news would be insulated by the fact that it should've risen on the anticipation of something good. We do not have anything close to that. The stock is dropping to 52 week lows. News and no news alike is not moving the stock. And now we see another stock in a similar position even after major news.
THTX has killed investor sentiment and it makes one wonder if even news of a mjaor announcement like JNCE had would get ignored until there is certainty of success in the trials. And then I wonder how much success it will take. Moving to a Ph. 1b from a Ph. 1a did nothing. It should have at least moved us further along the scale. Yet, here we are at a much lower price point compared to when we were in the Ph. 1a. So, maybe an announcement of efficacy will all of sudden produce a ton of new investor interest, but I'm a little worried nothing will be enough, at least anytime soon. That's an unrealistically extreme position, I understand, but good grief, we are where we are today in spite of ourselves and the market isn't helping either.
When someone like a ZipTrader, who knows nothing about the stock, can move the price double digit percentages by making a 30 second comment, or the guy from Fox News that listed THTX as a flyer can drive the stock up significantly on one announcement, we know without a doubt that there are investors out there looking to place capital, even if they aren't the kind of long-term shareholders a company can rely on. We have proof it is possible for the stock to increase in value without concrete evidence of efficacy or proof of concept or a partnership or any other next requirement because the last bit of information wasn't good enough. THTX has to start telling their story differently. I think they realize how bad they've screwed up to this point with investors and are starting to do things a little differently, but it's clearly not enough. The market has spoken. It's not reasonable to simply accept the current valuation and wait it out. Our expectations should be putting pressure on the THTX management team. They have a lot to lose too and cannot be happy with all the lost money from their personal shares.
Lee430 wrote: If I recall correctly Thera historically drops on good news, maybe we will finaly break that cycle with good POC news.
PWIB123 wrote: I would've expected JNCE's stock to skyrocket on the news of their recent partnership. The stock continued to drop. Does that concern anyone for our next potential moves with THTX?
PWIB123 wrote: I believe Jounce Therapeutics (JNCE) was used as an example of a deal that would be celebrated. Does it worry anybody that there was no big stock price jump on the news of that deal? Quite the opposite, the stock is continuing to drop.
scarlet1967 wrote: I believe the trial designs can be modified to serve the purpose for instance multi-center clinical trials with diverse ethnicity so the data can be presented to various related/targeted regional authorities, for instance THTX could start collaborating with a Chinese partner running trials in China the results from those centers and other centers can be presented to Chinese and other relevant authorities outside China or they can of course let the Chinese run their own trials. Thats my undrestanding, possibly a bit more complex and then add the politics to the mix!!
Wino115 wrote: Should have listed on HKSE instead of NASDAQ. We'd have $3bil mkt cap by now. ;-)
I think a deal will come fairly quickly on the back of just announcing they will be filing at least one pivotal for a specific cancer. They can then get full value on that with a partner and the partner can get first look at anything else, knowing full well they'll have to pay "market" at that time on whatever that indication is. I am not totally familiar with Chineses "FDA-like" approval processes but I would think it's like most countries where trials are for specific uses only and based solely on trial data (perhaps globally but I don't know).