RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:The potential oncology collaboration..Completely agree with you and glad you got the point of that post. Do listen to Reality here THTX mgmt. You really will do yourself and shareholders a huge disservice by not rehashing the full case of what you're doing with TH1902 for the single reason this understanding is completely gone from the market and you really need to build it back in to EVERY presentation and PR you do. Just keep repeating, repeating and repeating it. You will not be able to actually create a compeling and convincing INVESTMENT case without constantly reminding the market of
The Five Foundations of Sort1 Platform 1. Your original thesis from the day you bought Katana.
The Idea, bought cheaply. Safe, concentrated dose over long time frame --new way to deliver ANY cancer chemo.
2. What global academics and your pre-clinical all pointed at and proved invitro & invivo --
The Scientific Foundation 3. What you learned in P1 and hope to learn in P2/3 -
The Human Foundation.
4. The unique characteristics you've see --safety, durability, efficacy, unmet needs, anti-metastatic.
The New Paradigm/Market-Leader Foundation. 5. How it is novel, unique, first-of-kind and in high revenue markets. Why it WILL be used in hospitals and doctors can flexibly reach for it = $$$ --
The Financial Foundation Constantly reiterating
The Five Foundations, when you add all these up, you are making a massive and compelling
Investment Case for THTX A very simple exercise they should do now would be to write 1/2/3/4/5 as a 3-6 sentance statement and use it as the preface to any discussion around Sort1. Eventually, you can condense it down to one solid paragraph covering it all and use it as the preface for all the upcoming discussions from the oncology trials. By weaving these parts together into a very compelling and consistent WHOLE, it really makes for a more convincing story and investment case. Totally worth the effort in my book. They should not expect AT ALL that the market will just take a bland PR announcement and run with it. They need to use the art of marketing and sales, which Paul is good at.
The collective investment market has thrown Paul a massive amount of bricks, as we are close to 5 year lows. You have to use those bricks Paul.......
“A successful man is one who can lay a firm foundation with the bricks that others throw at him.” – David Brinkley
"You want a blue suit, turn on the blue light." Paul -- use those bricks to build powerful foundations in each area (1/2/3/4/5) and the market needs to be convinced beyond a doubt -- turn on the lights you know they want to see.
realitycheck4u wrote: TH Management - So let's say you get efficacy! Then what? Your PR news is not going to raise the share price. Why? Because you think people care, but the MARKET does not care. Sure some algorithms will pick it up - but no one cares. And it's because the story is just not at all being created. You throw bits and pieces. No one cares to sift through it over the past year. literally not even your BOD cares. They do not really get it. But worst of all, no one will understand if the PR said you have two cancers moving to PH2. Why? Because so does 100 other drug and research companies.
How are you different?
We know you are, but how does anyone else know?
You have been focusing on the science and trial. Great. But this is different.
You need a story. And you obviously do not know what that means - because we are the investors and you guys just do the science, management or PR stuff.
You need to really listen to what Wino wrote.
Wino's laid out the perfect story to ensure people give two sh*ts about TH1902.
Read below
Wino115 wrote: 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 scombined 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.