Daré Bioscience, Inc. (NASDAQ:DARE) Q4 2023 Earnings Call Transcript

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So we are still undergoing the activities that the FDA has communicated to us that are needed to support that IND. And so until we do — and that’s ongoing, so as soon as we have an update on that, we will definitely provide that update and then that timing will, obviously, be important in determining next steps. But the next steps with that program would be after IND submission, its next phase would be to go into a single Phase 3 registration study. And then in terms of VVA1, as I mentioned, and as you noted, so we have the IND application that is cleared and was supported by our Phase 1/2 results that we had generated last year. So at this stage, I mean, we’re definitely doing activities that would support preparations to moving into a Phase 2 study in terms of identifying clinical sites, protocol preparations, things like that.

We don’t plan to conduct the Phase 2 study until after we secure additional capital that would support it. But the next phase of that program would be the Phase 2, and as part of our IND process, we got really great feedback from the FDA on the Phase 2 design so that we could ensure that that would put the product where it needs to be to advance after that and really leverage kind of this first in category opportunity as a non-hormonal product for sexual pain. And I think this is…

Will Hidell: Okay. Thank you.

Sabrina Martucci Johnson: Yeah. Absolutely. Yeah. So, doing all we can to get them ready to move forward.

Will Hidell: Yeah. Thank you.

Sabrina Martucci Johnson: Absolutely.

Operator: And with that, that concludes the question-and-answer session. I would like to turn the call back over to Sabrina Martucci Johnson for any additional or closing remarks.

Sabrina Martucci Johnson: Well, thank you. Thanks for taking the time this afternoon and the afternoon before the holiday, sort of holiday weekend for some. So thank you for taking the time to hear about our recent updates and our ongoing commitment to drive value for all of Daré’s stakeholders by transforming women’s health. As you heard today, we made important progress in 2023 with our novel investigational treatment options that have the potential to expand choices and improve health outcomes. And we continue to work towards the goal of bringing innovative new treatments to market every day. We expect to have numerous 2024 milestones, including the quarterly revenue updates on XACIATO as that launch progresses this year, Ovaprene pivotal study updates as we work to complete what we expect will be a single registration study and updates on our discussions with the FDA and activities to commence Phase 3 for our potential first-in-category treatment option for women with female sexual arousal disorders, our Sildenafil Cream program.

And while not the focus of today’s call, our grant-funded product candidates enhance the portfolio and we look forward to providing relevant updates on those ongoing programs as well this year. With our unique model, support of our commercial collaborators and focus on fiscal responsibility, we believe we’re well positioned to accelerate innovation for women in a manner that also drives shareholder value. We look forward to keeping you updated on our progress towards the milestones we discussed today. Thank you again for your time and your questions.

Operator: Thank you. And that does conclude today’s presentation. Thank you for your participation today and you may now disconnect.

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