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: Laura Chico - Wedbush Securities Inc - Analyst
: Good morning. Thanks very much for taking the question. Just two for me. With respect to the Phase 2a readout, has the bar for seizure reductions
increased in the refractory focal population? We've seen some recent readouts there. So just curious, as you're heading into the Phase 2a, how
should we think about the bar for success for OV329?
And then second, given the safety tolerability profile, I think it certainly makes sense to explore a 7-mg dose, but wondering what additional data
you might have to support that? Thank you very much.
Question: Laura Chico - Wedbush Securities Inc - Analyst
: And just on the 7-mg dose, I guess, any additional data that gives you confidence there? Thank you.
Question: Laura Chico - Wedbush Securities Inc - Analyst
: Thank you.
Question: Ritu Baral - Cowen and Company LLC - Analyst
: Good morning guys. Hi, Meg, thanks for taking the questions. So back to seizure reduction, can you give us any more detail about this open-label
seizure-reduction study that you guys are thinking about? Will it similarly have no titration? And as we put all of this biomarker data together and
how you guys have comped it to vigabatrin, what sort of level of seizure reduction is that pointing to in this open label? And then I have a follow-up.
Question: Ritu Baral - Cowen and Company LLC - Analyst
: What are the assumptions for top-line data from that open label?
Question: Ritu Baral - Cowen and Company LLC - Analyst
: Got it. And then the when, like when do you think the -- when could you gather sort of the full seizure-reduction effect from 329, would that give
us from that open label? I'm wondering if that's like an 8-week endpoint or a 12-week endpoint. And would that allow us -- allow investors to see
seizure-reduction activity, say, in 2026?
Question: Ritu Baral - Cowen and Company LLC - Analyst
: Understood. And then last question, going back to what Laura said about the 7 milligram. So it sounds like you are confident that that 7 milligram
is getting you to the sort of ceiling effect of that pharmacodynamic range. I'm just wondering what other options may be in play given that very,
very clean safety profile that you have. It obviously changes the risk-benefit profile if that side effect profile remains that clean, the ability to dose
up.
Question: Ritu Baral - Cowen and Company LLC - Analyst
: Great, thanks for taking all the questions.
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OCTOBER 03, 2025 / 12:30PM, OVID.OQ - Ovid Therapeutics Inc to Discuss OV329 Phase 1 Topline Results
Question: Madison El-Saadi - B. Riley Securities Holdings Inc - Analyst
: Hey, thanks for taking our question and congrats on the data and a very nice presentation of the data set. Maybe on the 7-mg dose, would you
expect this dose to ensure all the treated patients kind of reach that area under the curve threshold that is needed to achieve benefit based on
your PK responder rate analysis? And then maybe on side effects, could you comment on the metallic taste? I believe there was one sedation. Is
this something that kind of resolved after a couple of doses? Thanks.
Question: Madison El-Saadi - B. Riley Securities Holdings Inc - Analyst
: That sounds very helpful. Thank you.
Question: Myles Minter - William Blair Capital Partners - Analyst
: Thanks, everyone. Congrats on the data. I had two on the data and then just one on the 7-milligram dose. So the first one is on the cortical silent
period data. You've shown a 10.4% increase in the FDI muscles, 6.7% in the [ABP]. Just wondering how that compares to Dr. Rotenberg's expectations
for that particular data that he announced at R&D Day.
And then the second is on the LICI. I think in the placebo arm for the FDI muscle that may have been numerically larger, the improvement there
than we saw with 329. So is that just low-end numbers, noise in the data there? I just wanted that explained.
And then finally, on the 7-milligram dose, is that pretty much just bringing forward the time to steady-state concentration as well? And are there
any sort of drug-drug interactions that we should be aware of considering, I would imagine these FOS patients are probably going to have three
or more concomitant meds if you enroll them. Thanks very much.
Question: Myles Minter - William Blair Capital Partners - Analyst
: It was, just any sort of drug-drug interactions that we should be aware of?
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OCTOBER 03, 2025 / 12:30PM, OVID.OQ - Ovid Therapeutics Inc to Discuss OV329 Phase 1 Topline Results
Question: Myles Minter - William Blair Capital Partners - Analyst
: Thanks very much for the questions. Congrats.
Question: Jay Olson - Oppenheimer & Co Inc - Analyst
: Thank you for providing this comprehensive update and congrats on the impressive results for OV329. Looking ahead to your proof-of-concept
study in focal onset seizures, could you please talk about lessons learned from previous focal onset seizure trials, especially with regards to managing
placebo response?
And how do the differentiating features of OV329 translate into potential clinical benefits versus other GABAergic anticonvulsants? And we have
a follow-on question if we could, please.
Question: Jay Olson - Oppenheimer & Co Inc - Analyst
: Great, thank you. That's super helpful. And I just want to follow up on the safety comments. It seems like today's findings support a level of ocular
safety that could preclude the warning for loss of vision and the requirement for ocular monitoring that vigabatrin has. So we're curious if that
clean ocular safety would eventually enable earlier lines of treatment with 329.
Question: Jay Olson - Oppenheimer & Co Inc - Analyst
: Excellent. Congrats again. Thanks for taking out the questions.
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