RE:RE:RE:RE:RE:RE:RE:Sec filing for 150000000$ Shelf Offering With ADCs getting approved with SN38 it may just be they think it offers something better than Doxorubicin. It's fine that Dox was used as a test system in the R&D phase and never goes to IND and the clinic. I do think SN38 brings something a little different to the platform given it's a much more toxic molecule that can't be used in a 'naked' form. I don't think it necessarily says anything about th1902 maybe just that they are thinking about the appeal of the SORT1 technology as a platform. If they back up Paul's comments about siRNA with some R&D with that molecule class then I would be comfortable that they are just exploring the broad applicability of the tech.
If there is no efficacy yet I expect it's raising nerves but it shouldn't be leading them to think it's a dud.
SPCEO1 wrote: I beleieve this is just a required update to the original shelf offering's prospectus and it is in addition to the ATM, just as the shelf and ATM have co-existed already. So, they have different ways they could go with financing should the choose to do so, a decision that will be driven by the phase 1a results and the board's willingness to risk it in NASH when no other partner appears to be rushing to fund their trial (but one was willing to spend really big bucks to fund an earlier trial from a competitor - not a good look for TH).
I have not had time to read it yet but perhaps the only new news was the re-allocation of pre-clinical resources away from TH-1904 and towards SN32? If that is correct, does that suggest they are moving forward in a natural progression because of what they are seeing in TH-1902's phase 1 or they are changing strategy towards a more powerful chemo because they are not seeing the efficacy they had hoped to see so far with TH-1902?
palinc2000 wrote: Thx for comparing the wording
I must admit that I did not see that coming at least not during this week,
Legally I think this is in addition to the ATM but I may be wrong
qwerty22 wrote: And this is the wording in the atm. So this is in addition to ATM?
palinc2000 wrote:
The conduct of the Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH in the general population will be costly and the Corporation has decided to secure additional resources, including finding a partner, prior to initiating such clinical trial, all of which will result in a postponement of the initiation of such trial. Although the Corporation has begun the search for a potential partner, there can be no assurance that a partner will be found or that a partnership agreement will be entered into on terms satisfactory to the Corporation. If a partner is not found, the Corporation will need to look for alternatives to secure additional resources but there can be no guarantee that the Corporation will secure such resources in an amount sufficient to initiate its Phase 3 clinical trial. Moreover, the Corporation has no meaningful Phase 2 clinical data evaluating tesamorelin for the treatment of NASH in the general population and any results obtained from the conduct of one Phase 3 clinical trial will have to show substantial evidence that tesamorelin is safe and effective for the treatment of NASH in the general population. Finally, the Corporation’s decision to design its Phase 3 clinical trial to meet the FDA’s primary endpoints may prevent the Corporation from seeking approval of tesamorelin for the treatment of NASH in the general population from the EMA since the primary endpoint for this agency is different from that of the FDA. If the Corporation is unable to secure additional resources to initiate its Phase 3 clinical trial, the conduct of such trial could be cancelled. If the Corporation is unable to meet the endpoints of its Phase 3 clinical trial, it will not receive approval for tesamorelin for the treatment of NASH in the general population. And, even if the Corporation meets the endpoints of Part 1 of the Phase 3 clinical trial and obtains a conditional approval letter from the FDA, the Corporation could lose such approval if Part 2 of the Phase 3 clinical trial is unable to show evidence on the resolution of certain clinical outcomes. If the conduct of the clinical trial is cancelled, or if the Corporation does not receive approval for tesamorelin for the treatment of NASH in the general population, its potential long-term revenues, growth and prospects will be materially adversely affected.