RE:RE:RE:RE:RE:RE:RE:RE:Financial and othersTo me, this is a huge blow to PL's credibility. It was just weeks ago that he was messaging a firm start to dosing be the end of Q3, now dosing isn't on the radar. That does not sit well with me and even makes me start to question the oncology results. Mr Market has this one dialed in... Show me the results, because your talk (and/or lack thereof) is worthless.
jeffm34 wrote: It's a credibility issue. The company was quite adamant they were dosing patients in Q3. So what changed in their eyes?
Did they finally just realize what everyone else knew?
Did they wrongly assume they would have found a partner by now?
Did they think they could just do another round of financing to fund it on their own?
They claimed it was the 25% increase in cost. They still didn't have enough money to do it even at the lower cost.
qwerty22 wrote: This is simple and complicated.
For this to be a clinical program they would have to have a plan to dose patients, biotech 101. They have no plan to dose patients, it's no longer a clinical program. That is shelved, it might get re-activated but it's shelved now. That seems pretty clear to me now. They aren't going to unlock value that way. What they've been signalling since the move to general NASH has gone, parked. The market was right to be sceptical about that.
What this now is is an asset sale. They call it partnering but they want somebody else to move this program forward. The asset is Grinspoon's data set, the IP and the regulatory outcomes they've secured. I don't know if I ever said this out loud here but having seen how little the market wanted this program I had thought the package was really intended for partners or at the very least would be more appealing to partners. Just to be clear the market hates this, it's more appealing than that, I don't know exactly how appealing it is. I do think a pharma could more appreciate Grinspoon's data although I do think they'll see the holes, I think we know the warts and all on the data though. I think they will appreciate understanding where the regulator stand an awful lot, although we don't know the warts and all it's a lot clearer today. I don't think things need necessarily to be perfect for a partner, they'll think they can bring their own expertise to this asset, but they do need to have clarity and I hope that's what the company has achieved, some clarity.
The opportunities have significantly narrowed for NASH. The positive is they've put a package together. The negative is it's not good enough for them to proceed alone. It may be appealing to a partner but that's looking more like a Hail Mary play. They still look far from realizing any value in this asset.
I've written that and now had a different thought.
If the chased this alone it's -:
high risk, high reward, long, costly and probably unsupported financially. I pretty much thought that play never made sense, it's just annoying it took the company this long to admit it.
If they chase a partner it's
Pretty much no risk, much lower reward, little further extra capital investment and it might actually resolve quicker than a trial but they'd be giving up most of the value. Maybe a few tens of millions is better ploughed into cancer.
But to be clear that billion dollar asset (that never existed) did just disappear. Right?
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