RE:The real quick story of TheraRereading myself, I was obviously talking about the biotech boom of the 2000 decade. But this mistake shows how old Thera is, and how old I am...
Another thing I can say, is that Thera made three big mistakes with tesamorelin. First they did not get the patent protection right, that was a huge mistake, and you needed to read the annual information form to learn about it after the facts. The second big mistake was the F1 formulation that was used for commercial launch, and for many years after that. That was another big mistake. That being said, their third big mistake is a proof they knew that they messed up with the F1 formulation. They developped better formulations around 2012, I think they had F2, F4 and F8. But they waited a very long time to make bioequivalency studies and replace F1. For that matter, F8 is still not in place 10 years after its development by the company.
So looking back at these past mistakes, you will better understand why I insist so much on confirming sortilin overexpression as soon as possible. Also, why I want them to start working on a imaging version of their PDC. I was advocating for Ga68-DOTA-TH19P01, but my recent readings lead me to think that Cu64 would be a better isotope to use because it has a much longer half life than Ga68. So it would allow to do the SPECT scans in any hospital with SPECT scanner, while in the case of Ga68, only research hospitals with a cyclotron, like CHUS in Sherbrooke can do it, because the imaging PDC with Ga68 needs to be injected shortly after final addition of the isotope on it.
Anyway. Add to that my personnal experience with therapy and scanning involving PDCs, and it is one more reason why I know very well how important it is. Also, when I was treated with Lu177-Dotatate, the injected dose was adjusted to my tumor load and my renal clearance capacity. So it was a personalized treatment better than Lutathera which is a fixed dose of the same PDC.
I know that TH1902 is very early in its development and that it would be foolish to think that Thera could be where they are with Lu177-Dotatate, but as I showed with the F1 formulation for tesamorelin, they need to be proactive as soon as they will have a clear proof of concept. Tesamorelin (Egrifta) is a clear proof that getting a drug approved is not the end of the road. They need to play chess and think three or four moves ahead. I know i repeat myself, but you cannot develop a targeted therapy without aiming that one day you will be able to clearly assess the sortilin expression and distribution in tumors and healthy organs and tissues.
Again, I got liver biopsy and whole body tumor imaging, the difference between the two procedures is night and day. I understand that some biopsies are easier to make than liver biopsies, but still. When you think about the future of the SORT1+ platform, it must include an imaging PDC. Animal work could be started right now at low cost. You could start collaboration with experts in this field. Also, a corporate presentation that would include the fact that they are working at developing such an imaging tool would make it much more convincing. Somebody with a scientific background would read it and say that this company is professionnal and very serious. Right now, at least in what they released publicly, it looks a bit amateurish with their approch based on sortilin overexpression probability. They, at least, must send the signal that are working to change that as soon as possible.
jfm1330 wrote: Theratechnologies, founded in 1993.
For many years they had no labs, they were buying patents from academic inventions, the patent to N-Hexenoyl; GRF (1-44), later called tesamorelin, and commercial name Egrifta was one of those patents. In the begining they were all over the place, they worked on a cancer treatment against leukemia that ended up in nothing, they started a medical device division, I remember they had an electronic stethoscope and other stuff. In the biotech boom in the 80s they were able to raise money. They started pushing tesamorelin as their lead drug, they also worked on a GLP-1 analog but were late in the game behind big competition so they dropped it after phase I. They bought a peptide desing company called Pharma-G, and hired the founder of this company as CSO. Nothing never came out of that acquisition.
Then, around 2010 they got tesamorelin approved by the FDA for a small indication, HIV lipodystrophy, and the company was forced into a partnership with EMD Serono over a patent that Serono had. So instead of a legal fight over that Serono patent, they concluded a partnership. Sales of Egrifta by EMD Serono were small, Thera was losing money in that bad deal because they still had to pay to run phase IV post-approval clinical trials and manufacturing. They also had manufacturing problems around 2012. They hired a new CEO, John Huss, a former big pharma executive. A financing in the US failed at that time when the company was on NASDAQ. It was the last window for the company to get a good amount of money without too much dilution. After that everything went south. They were low on money because of the failed financing, so they had to lay off about 80% of their employees. Went close to bankruptcy. Were savec by some tax credits reimbusment for the governments. The new CEO, long time CFO, Luc Tanguay managed to save the company in a deal to buy back from Serono the full rights to Egrifta. Then he managed to get the right to Taimed's Ibalizumab (Trogarzo) which, at the time, was about to enter phase III trial.
Trogarzo was finally approved by FDA in March 2018. The stock price went to 14$ (CAN) in May and June on high volume. Then it started to go down, and down, and down, and the sales of Trogarzo were minimal in the US. In other words a commercial failure. Thera also bought the rights for Europe, another failure. During all that time they managed to have Egrifta minimally profitable, and in Ferbruary 2019, Thera bought Katana Bioscience, a university startup with an oncology platform based on the peptide-drug conjugate aiming at a receptor called sortilin. The technology was still at the preclinical stage. Thera bought it for a few million dollars with the intent of investing in its clinical development.
Now we are in August 2022, Trogarzo is still a commercial failure, Egrifta is marginally profitable, the first PDC out of the SORT1 platform is in phase Ib with some efficacy signs out of a very long phase Ia. The phase Ib for this targeted therapy is done right now without screening patients for target receptor overexpression, which is the basic concept of the whole thing. So they run their trial based on probability of receptor overexpression. Not great.
So. If you are an investor new to Thera, and you do your due diligence on the history of this company, with what is publicly known right now, would want to buy the stock? At this time, with the long history of of failures and underachievments of this company, and what is publicly known at this time, do you think there is a reasonable way to honestly present things to make an appealing investment opportunity? Turn it the way you want, all lies on convincing oncology results, and at this point, there is so much noise in the phase Ia results, and there will be so much noise in the phase Ib results, that you really need to have a scientific background to understand what is known of the situation, and on top of that, you need faith. You need to believe that the little efficacy signal in all the noise is a real signal. You need to believe that they have something, and that once they will be able to reduce the noise significantly, the efficacy signal will be clear as day, and that it will be clear to everybody that they have a future FDA approved drug in their hands and maybe more than one drug because of the platform. But at this point, this positive scenario is not obvious at all.
So that's Thera yesterday and today. Sorry, but they need a dramaticly positive news in oncology to change the story and make it attractive.