I have a few issues with this Sandstone Analyst Report.
First, the analyst(s) responsible for the report is not identified.
Second, the analyst says that Neuren is focused on both neurodevelopmental and neurodegenerative disorders. Neuren’s focus, since quite some years now, is solely on neurodevelopmental disorders. And Jon Pilcher has recently confirmed that neurodevelopmental disorders will remain the Company’s focus.
Third, the analyst asserts that Neuren plans to take all four current indications through Phase 3 trials itself. I have certainly heard Jon Pilcher say that the Company wanted to get NNZ-2591 to patients as quickly as possible. I have also heard him say that Neuren could comfortably execute and fund two indications itself. But I have never heard him say that the Company is planning to run four Phase 3 trials concurrently over the next three years. Nor have I heard him provide details such as when the trials are likely to start, how big they’ll be, when they expect to finish etc. He has repeatedly declined to go into detail, consistently saying that “we need to meet with the FDA first”. Jon has stated that the post-Phase 2 meeting for PMS with the FDA will take place in Q3 but has refused to be more specific. He has also said that the Company doesn’t know when it will meet with the FDA for the End-of-Phase 2 PHS meeting.
Which brings me to my fourth point of concern – the analyst’s claim that the Company hopes to have all four proposed trials completed within the next three years. How, for example, will Prader-Willi Phase 3 be completed within just 3 years? The new Phase 2 PWS trial won’t commence until after the Q3 EOP2 meeting, so, at the earliest, in Q4 24. Even with a more efficient trial, allow at least 1 year until Phase 2 read out (Q4 25). Then, as seen already with trofinetide and NNZ-2591, allow at least a year for preparation of Phase 3 (Q4 26). Using Acadia’s PWS trial as guide, allow another 2-2.5 years until Phase 3 results (2029). That’s certainly more than 3 years. Then one needs to add a further 1 – 1.5 years for NDA submission preparation and review (2030). So I’m really not sure how the PWS drug can be on the market by the analyst’s expected date of 2028/2029.
Adding to my scepticism of the claimed Company plans to complete the four Phase 3 trials in-house over the next 3 years is Jon Pilcher’s statement that further indications are planned for clinical development but won’t be announced for "some months"; more specifically, until NEU is ready to commence Phase 2 trials. So NEU would be running those Phase 2 trials concurrently with four Phase 3 trials??
My final concern is the analyst’s claim that, should all Phase 3 trials be successful, “NEU aspires to almost double the royalty and milestone metrics it achieved for the US licensing of DayBue.” Strange, my recall is that the only thing that the Company has committed to is “achieving the best outcome for shareholders by pursuing value-adding opportunities to their fullest potential and…. continu (ing) to evaluate all options to achieve this as the events of this year unfold.”
In conclusion, I do not find it possible, yet alone probable, that Sandstone’s “insights” have been informed by Jon Pilcher.
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