Jon made clear at the AGM that the priority in spending is advancement of NNZ-2591.
The expected cost of the Phase 3 PMS trial, due to commence shortly, is said to be US$80-$90 m. Be it renovations or clinical trials- always allow for the higher estimate. So that’s A$140 m.
Jon also said that there are plans to speak with the FDA later this year to reach alignment on Phase 3 trial design for Pitt Hopkins syndrome and Angelman syndrome. If the Company chooses to move ahead with both trials, allow another A$280 m.
Also planned before the end of this year is a meeting with the FDA to work out the way forward for NNZ-2591 in HIE. The Company is keen on a single pivotal Phase 2/3 clinical trial. This is likely to have larger patient numbers than the other Phase 3 trials and potentially cost more.
It has also been stated that there are a couple of other indications, yet to be announced. Previously, Jon has said that he doesn’t intend to announce these indications until they are close to Phase 2 trials. So, provision probably needs to be made for at least two more Phase 2 trials.
Finally, the Company needs to keep going with its preclinical work identifying further suitable clinical candidates for NNZ-2591.
The cash position at 31/03 was A$341 m.
Allowing for ~A$20 m being spent on the SBB since then + two months expenditure the cash position might now be ~ A$315 m.
Even allowing for the royalties that will keep flowing in, I don’t believe that spending a further A$100m on SBB is prudent.
NEU Price at posting:
$13.97 Sentiment: Hold Disclosure: Held
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