RE:RE:RE:RE:RE:RE:RE:RE:Financial and othersIt's not a clinical program until
it is, it's definitely an operational program part of their overall business. What they are doing with that program is not shelving it but exploring various options.
NASH is a massive market many companies starting from preclinical to various stages of trials spending huge amounts of funds chasing those financial opportunities. Now after two years of back and forth negotiations with both agencies they have a clear protocol ready to start so although NASH trials have been thus far unsuccessful a ready to go phase 3 protocol can create some interest from other companies specifically as there is apparently only 6 phase 3 trials for NASH. As an investment thesis the more unsuccessful trials the less appealing for investors but from a business standpoint the more trials failing the better.
qwerty22 wrote: There is NO PLAN to dose patients. You can't have a clinical program without patients. It's no longer a clinical program it's an asset sale.
scarlet1967 wrote: To claim the NASH is shelved or inactive is not correct, they have a ready to go program both in Europe and US which took almost two years to finalize as per partnership these deals will take long time to finalize, it won't happen overnight as per CEO they are currently talking to interested partners again as per CEO they certainly won't give it up absent suitable partners.
Wino115 wrote: All fair points. I don't think it's inactive though, that's strong words. PL mentioned they've drawn up a strategic roadmap for all options and plan to be a NASH company one way or the other. As you say, one way could be small trial but I don't think they would do that given timing. They are still an early entrant, so don't underestimate that option value.
But I think what they've done is to buy some time (perhaps what you mean with inactive) and in that time they may be transformed. Transformed enough to be highly confident they could pay the 25% higher cost if need be. So you discuss partnerships for 6-12 months, sign one of it makes sense, and in that time you know your forward financial situation a lot better around SORT1.
qwerty22 wrote:
The search for a partner is just a positive spin on the fact that the program is parked, shelved, whatever you want to call it. Until something different happens. We really are in Hail Mary territory if it's relying on finding a partner, basically they can't get the market to finance this. I think you should think of this program as inactive until we get news to the contrary.
"None futility" is just the recognition that they don't have anything to guide them on where the Ph3 endpoints will land. The Ph2 data set is incomplete. It's clearly more impactful that this is coming from the mouth of one of the regulators.
So they are going to do nothing until something happens. What this program clearly needs is to dose more patients and get the right data from those patients. I don't understand now that what they've been chasing has clearly hit an unpassable roadblock (unless a partner turns up) why don't they just commit to a smaller trial with the intention of getting a answer to the none futility issue, it wouldn't be 400 patients. I guess they don't want to tie the program to that trial for the next 2 years maybe that's not commercial viable either.
This program needs more data, it needs to dose more patients and that seems to be the one thing the company will not commit to atm.
palinc2000 wrote: I guess end of May was still in pandemic country which could explain sales,,,,
Could the search for partners have been delayed till the interim futility analysis ( 400 patients)
If there is no efficacy then the trial would presumably be stopped and t he costs till then would be lower than was originally expected,,,,
scarlet1967 wrote: On oncology reading between lines the trial is progressing well. On NASH they have completed the negotiations with both agencies and have EMA onboard. They need now to do an interim futility analysis on 400 of total 1100 patients for 18 months (75 to 100 HIV), post approval will include additional 1800 patients. So my take is the EMA wanted that interim analysis included in the trial process and the total patients increased for phase 3 from 900 to 1100 and post approval from 1100 to 1800 patients resulting in more costly trial. As a result the company would like to find a partner for the program. That would be the ideal situation not only it brings resources/credibility but de-risk the program. This could delay the launch of the trial.
They have about still 57 millions which is a positive surprise. The sales were not great but let's see what they have to say about sales going forward.
As predicted NASH is very much on the table and EMA is onboard, the reason for futility analysis might be to to get more biopsy confirmed fibrosis patients and most likely to convince EMA to accept their harmonized protocol.
The good stuff is EMA is onboard, they will looking to partner up for NASH, oncology is progressing well and they seem to have same amount of cash now as end of February. The bad stuff is more costly NASH and not unexpected less sales.
"Our Phase 1 clinical trial of TH1902 for the treatment of sortilin-expressing cancers progressed as planned during the quarter and we believe that we have developed a targeted peptide-drug conjugate that may potentially transform the way cancer is treated".
palinc2000 wrote: Disappointing sales and change of plans im Nash -start of Phase 3 Trial delayed and THTX looking for a partner in Nash due to higher Phase 3 costs