The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: So obviously, I don't cover practice, but I cover UCB in Lundbeck, I'm quite familiar with the kind of epilepsy space. I know that you guys have the
EMBOLD trial and relutrigine, I think I pronounced that correctly, looking at the developmental epilepsies. Now this is an increasingly competitive
space with, Lundbeck acquiring Longboard, bexicaserin; with Fintepla, obviously, from UCB involved in Dravets and LGS. And obviously now Biogen,
Stokes, zorevunersen. So given this increasingly competitive landscape, what is it that gives you confidence around your product, around really
providing a differentiated offering?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: Yeah. And so in terms of the -- like that, I think, quite clearly lays out the proposition of the product itself in terms of what we're waiting for from
the Phase 3 EMBOLD study, like what should we really be looking to interpret, and how is enrollment progressing for that second registrational
cohort? Is that still on track for 1H '26?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: Just to the point about no one else being late stage, maybe if you could just kind of highlight then the difference between relutrigine and --
relutrigine and bexicaserin. Obviously, Longboard have been talking about trying to pursue a broad DEE label. And Fintepla hasn't been already
on the market, it's just Dravet, it's just LGS, looking to bring in [30k five]. Like where are you positioning within that current setup?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: That makes perfect sense. So then moving on, NBIX had a Nav1.6 asset which they discontinued. And so how confident are you in your assets, given
this apparent step back to the space, and is this coming -- comes down to a differentiation on the chemical motif or study design?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: Excellent. So maybe then moving to your kind of other developmental and epileptic encephalopathy products, you've got PRAX-222, which is
elsunersen. I believe you've been in conversations with the FDA. What's the latest feedback from those meetings you've been having? What's the
outlook there?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: Brilliant. And then I think one more is PRAX-020, which has recently -- I think we've just had progress on your partnership from UCB with like deciding
to buy into that asset. So what's the latest on timings there? How's that partnership progressing, given there's no approved treatments for that
KCNT1 epilepsy subset? How many patients might that reach?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: So then just double clicking on that kind of UCB relationship, obviously you have been working closely on this asset. UCB is the kind of leader within
the epilepsy field for a number of years. It's also trying to continue to innovate itself whilst Bimzelx is what's taking over most people's interest, but
Fintepla is doing a great job there, like Vimpat, Briviact, whatever. How do you see UCB's partnership as critical for your future relevance from a
commercial standpoint for your future product?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: Do you have any -- I mean, pardon the ignorance, but I mean, what other relationships do you have with them? What are the kind of terms of the
agreement that you've got for PRAX-020?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: Okay, and then maybe just on -- you've mentioned again that kind of KCNT1 is a relatively small subset of patients, very high unmet need. What
sort of proportion of the epilepsy market does that account for, in terms of those with unmet disease?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: So maybe then just coming back to relutrigine, given you are moving into these later stages, what is your commercialization plan for this asset?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: Understood. I think there's going to be one more slightly earlier phase product to really touch on for this session is vormatrigine, your PRAX-628
focal epilepsy product. So you've just had the Phase 2a results, and so what what is the update on that? How are you feeling about that product
going forward?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: Makes total sense. I do want to leave a little bit of time to talk about US tariffs and policy outlook, but maybe just one step back question, more
kind of ethereal. What it -- given you're focusing so much on the neurological space, it's a very hard area to change the treatment paradigm, you've
got some very exciting early stage assets, what is it that you guys do at Praxis that gives you that level of confidence that you can achieve what
others haven't?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: And so then just in the final minute of our chat today, could you just give me a little bit of an update on the US political and regulatory landscape
that you see? Kind of what are you expecting in terms of any potential supply chain disruptions or how FDA communication has changed with you
guys to date? And maybe just on the kind of NIH funding outlook, less problematic near term, but maybe over time that could have a bite?
Question: Charles Pitman-King - Barclays Capital Inc. - Analyst
: And then any final comments, Marcio?
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