NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Q4 2022 Earnings Call Transcript

Jonathan Javitt: You just said something very important and it’s one of the early things that FDA guided us on when we first met with them. It’s pretty well known that suicidality comes and goes and it may not be something that patients talk about as readily as symptoms of depression. So, the guidance we got from FDA early on because our original thought was that our primary indication we be the suicidality score. The guidance we got from FDA was to make the primary endpoint for our studies that measures depression scale. And the exact words, if you’re able to prove that you improve depression in this population of patients who have suicidality, who have been excluded from previous trials, where there is no antidepressant that’s indicated for use, no oral antidepressant because there’s been some encouraging data with Johnson & Johnson does ketamine product, but there’s no oral antidepressant that’s indicated for use in these patients with suicidality, that’s great.

That’s enough to win. And if at the same time, were able to show that the secondary endpoint of improvement on the CGI suicidality scale is also significantly better than the comparator drug. Well, that’s even better. But that’s why our primary endpoint is the measures depression scale.

Vernon Bernadino: Thank you. I appreciate that. And I am very hopeful for you and the patients out there. Thanks again for taking my question.

Stephen Willard: Thank you, Vernon.

Operator: The next question comes from Ed Woo of Ascendiant Capital. Please go ahead.

Ed Woo: Yes, congratulations on the progress and also on the DSMB readout. Do we anticipate any more readouts or any interim data for either one of your studies this year?

Jonathan Javitt: We do expect that the DSMB is going to look at the data again at some point I would guess before the end of Q3, but they haven’t told us exactly when that readout is going to be, but they’re going to be monitoring the study in an ongoing way to the extent that there are safety signals emerge, they might look sooner. But they’re working with us very closely because this is a population of patients who are actively at risk of self-harm, which is why they’ve been excluded from trials of ordinary antidepressants.

Ed Woo: Great. Well, thanks for answering my questions and I wish you guys good luck. Thank you.

Stephen Willard: Thank you.

Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Suzanne Messere for closing remarks.

Suzanne Messere: Thank you, Danielle, and thank you everyone for participating. That is all the time we have for questions. Thank you again. This concludes the NRx Pharmaceuticals’ full year 2022 results conference call.

Operator: The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.