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

And so we’ll have top line data in the second quarter, as you talked about and then we’re looking to very shortly thereafter, have the full data set. And we’ve already lined up our advisers to be working with us as we kind of mine through that and prepare and request that end of Phase II meetings with the FDA. And as we always do, I alluded to already a lot of interactions with the FDA and we try to be super communicative. So we have already given the FDA know where we are on the program and that we look forward to speaking with them about the Phase III results. So our hope is that we will be able to move very quickly this year towards those conversations.

Operator: That concludes our question-and-answer session. Ms. Johnson, I turn the call back over to you.

Sabrina Johnson: Thank you. And I’m looking at the time and thank everyone for your time this afternoon to hear about our recent updates and our ongoing commitment to driving value for all of our stakeholders, the women, the health care providers, our shareholders, with our diversed portfolio, we really seek to bring to market differentiated prescription therapies that prioritize women’s health and wellbeing, expand those treatment options were not exist enhance the outcomes where current standard of care has meaningful sure comings and improve ease of use for women where a more compelling form factor can drive adoption. And as we talked about today, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility.

— and our focused efforts to deliver differentiated innovation in women’s health, as we talked about, it resulted in our 12 development stage programs across 9 distinct indications, the more than 5 milestones anticipated for this year 2023, the 3 candidates and are nearing Phase III development, our 2 potentially transformational collaborations with the leaders in women’s health product commercialization Organon and our first FDA-approved product, XACIATO. So as I mentioned at the onset of the call, it’s our belief that prioritizing women’s health is good for the many women lacking effective or convenient therapeutic choices and good for a broad set of stakeholders, including their families and partners and, of course, our shareholders. So we very much look forward to keeping you updated on our progress, on the milestones that I outlined earlier that we have anticipated for this year.

So we’re talking a lot about this Sildenafil Cream, Phase III RESPONSE study top line results, the U.S. launch is XACIATO by Organon, the initiation of our pivotal study of Ovaprene, the IND-related activities that we were talking about for DARE-HRT1 and DARE-VVA1 and importantly, the Phase III and Phase II, respectively, clinical study initiation plans and DARE-PDM1 Phase I study top line data that we’re looking forward to this year as well. So thank you for your time today. Thank you for following and thank you for those who asked all the great questions.

Operator: This concludes today’s conference call. You may now disconnect.