Daré Bioscience, Inc. (NASDAQ:DARE) Q4 2022 Earnings Call Transcript

And that’s because there is an interplay. This should not be surprising for anyone. Again, no different than erectile dysfunction. There is a physical component to an arousal response. And then there’s an emotional, right, component, an interest level component. If you are not able to have a physical arousal response, a portion of the population will not be interested over time, right, because they’re no longer — it’s all related in some ways. And so there is a population, some studies have estimated at around 50% who have both arousal disorder and lack of interest. So similarly, we have attempted to conduct our Phase IIb study and our selection of the patient population and this is part of why we took time in rolling subjects and characterizing them and screening them so that we will actually be able to, with our data set, look at data a lot of different ways, women who only have arousal disorder, women who have a combination of arousal or lack of interest as well as other, right?

There’s women who have arousal disorder like so there’s lots of different permutations that we’re going to be able to look at and we’re super excited to be getting — it’s a big step for the field to be getting these data and there’s going to be a lot that we’re going to be able to dig into and then hopefully get ready for those interactions with the FDA on the next step. That was a long answer to your question and hopefully that covered it.

Operator: Your next question comes from the line of Douglas Tsao from H.C. Wainwright.

Douglas Tsao: Just maybe first on the Sildenafil Cream program. How are you thinking about the commercialization strategy? And what I mean specifically is, obviously with XACIATO and Ovaprene you’ve pursued partners. I know in the past, you’ve contemplated or said that you’re thinking about the right time to potentially become a commercial organization. When do you think you need to make that decision? Is that something that would be done like XACIATO after we have Phase III data and maybe not necessarily after approval but — or would this be something that potentially could happen before a Phase III program? And then also, as a final follow-up, just in terms of enrollment, you’re thinking about the Phase III. I understand your point about sort of looking at the data in terms of and cuts in terms of patients with arousal as well as lack of interest.

But is there — is one study enough to potentially sort of validate or give you confidence that you could enroll patients with sort of multiple manifestations of sexual dysfunction?

Sabrina Johnson: Great. Both of those great questions. I’m actually going to take them in the — I’m going to start with the second one and then I’ll talk about our go-forward strategy. They’re kind of tie together. So first of all, as you highlighted, — and that’s why we really refer to this as a Phase II exploratory study. There’s a lot we’re going to learn from this study being — it’s fantastic to be groundbreaking as we are in this way. It really affords you a lot of opportunities to pave the path that others will have to follow who come behind you. And so that’s definitely something that we’re going to be looking at closely here as we look at these data is how do we want to define the patient population. We want to define it at the best we can for our cream, our Sildenafil Cream and where this product is going to do well and do well in a way that whoever follows is going to have a hard time meeting.