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: Brian Abrahams - RBC Capital Markets - Analyst
: Hey, good morning. Thanks for taking my question. Can you elaborate a little bit more on some of the differences between the vendor that you
utilized for KOASTAL-1 and SAFER? And any changes in the site auditing and patient caps that you've utilized in KOASTAL-1 that you'll apply for
KOASTAL-2 and 3? Thanks.
Question: Brian Abrahams - RBC Capital Markets - Analyst
: Got it. Thanks, Josh. Thanks, Bill.
Question: Douglas Tsao - H. C. Wainwright & Co. - Analyst
: Hi, good morning. Thanks for taking the questions. I guess a couple for me. Maybe just as a starting point, I think it might be helpful if you could
provide some perspective in terms of how far along into enrollment KOASTAL-2 and 3 are right now? And just broadly, how impactful do you think
these changes could be? And then I guess I was just curious if in the work you did, you were able to identify anything that might have led to the
very distinct effect or differences in effect that we saw between male and female patients in KOASTAL-1?
Question: Douglas Tsao - H. C. Wainwright & Co. - Analyst
: Okay great thank you so much that's helpful.
Question: Paul Matteis - Stifel - Analyst
: Hey, thanks for taking the question. I guess one thing I'm a little bit confused about is during KOASTAL-1, the team was really confident that the
study was going well that it was well conducted. I remember talking to Henry about leveraging sites that were high-performing sites from the
Phase II study and using central raters. And so I guess as you look back or you look back to kind of your thought process six to nine months ago,
what do you think you missed while the study was going on?
What do you think led you to think the study was well conducted, when ultimately now in hindsight, it doesn't feel like it doesn't feel like it was.
And then just secondarily, on cash runway, certainly pretty tight with these studies. I understand that you're extending that guidance, which is
great to see. But what's your thought process there? And I guess how comfortable are you to go into these readouts with materially less than 12
months?
Question: Tess Romero - JP Morgan - Analyst
: Hi, good morning team. Thanks so much for taking our question.
So NMRA-266 has been on clinical hold for almost a year. Why has there not been an update? And can you provide a little bit of color on your latest
thinking on if the convulsions that were observed preclinically with the product or specific to the candidate itself? Thanks.
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