This forward from the annual report was signed not just by JP but by the chairman of the board.
" achieving the best outcome for shareholders by pursuing value-adding opportunities to their fullest potential."
This indicated to me the majority opinion of the board, (the Chairman wouldn't have signed off on this statement otherwise), is the take 2591 through ph3 for at least PMS, and maybe doing a few more ph2 trials for other indication before accepting any TO offers.
Perhaps, but it depends on how many value-added activities the Board feels need to be pursued and how far the Board thinks they should be pursued.
I would think that, at a minimum, the Board would be aiming to achieve the following:
So, it seems likely to me that all of these “value-adds” will be in place by the end of Q3, so any time after that presents as a potential exit point for the Company, in my view.
- Success in a second Phase 2 trial of NNZ-2591. This not only increases the value of the Pitt Hopkins asset but also allows greater confidence in results seen in the first PMS trial and increases the likelihood of success in further NNz-2591 trials. This point will be reached by the end of this quarter, if Pitt Hopkins results deliver. Another opportunity presents by the end of Q3, if Angelman results deliver.
- Completion of non-clinical (toxicology) studies necessary for Phase 3. This has already been done.
- Manufacturing of commercial-standard doses necessary for Phase 3. This has already commenced.
- FDA go-ahead for Phase 3 PMS trial design. Meeting is planned for Q3.
- Expand preclinical data in further indications of NNZ-2591. The Company has already been working on this. The fact that they are now talking about this suggests to me that some success has already been seen and we are likely to hear more before the end of Q3.
The alternative, as you suggested, means waiting an additional 2+ years.
While I think that Neuren could afford to go it alone for Phase 3 PMS (and that’s important for bargaining from a position of strength were any T/O negotiations to occur pre-Phase 3), it would chew up most of NEU’s cash reserves and does not come without risk.
As for taking a partner for Phase 3 PMS, I actually see that as potentially devaluing any future T/O offer.
In summary, from Q4 is the T/O sweet spot in my view.
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