Good . My name is Joanne, and I will be your conference operator today. At this time, I would like to welcome everyone to the Dare Bioscience, Inc. Q2 2022 Conference Call. [Operator Instructions]. Ms. Johnson, you may begin your conference.

Wonderful. Thank you. Good afternoon, and welcome to our Second Quarter 2022 Financial Results and Business Update Call for Dare Bioscience. Our plan today is to review our second quarter results, discuss development since our last call in May and use the time to review our business strategy and highlight our objectives and milestones anticipated for the rest of 2022. Before we begin, I would like to remind you that today's discussion will include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our annual report on Form 10-K for the year ended December 31, 2021, which was filed on March 31, 2022, and our quarterly report on Form 10-Q for the quarter ended June 30, 2022, which was filed today. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, August 9, 2022. Dare undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. As you know, Dare is solely and squarely focused in women's health. It is our belief that prioritizing women's health is not only good for the many women lacking effective or convenient therapeutic choices, but also for a broad set of stakeholders, including their…

Thanks, Sabrina. Given the stage of our current portfolio and market dynamics in the therapeutic categories, specific to XACIATO and Ovaprene, we believe the best avenue to generate value for Dare and its shareholders is via external commercialization collaboration or out-license agreements rather than attempting to commercialize these assets on our own. Opportunity to enter into such collaborations are ultimately contingent upon developing differentiated products that demonstrate the potential to be first line or first in category. So let me begin with bacterial vaginosis and our first FDA-approved product XACIATO. As we've mentioned on previous calls, bacterial vaginosis is the most common cause of vaginitis worldwide and is estimated to impact approximately 21 million women in the U.S. The condition is a result of an overgrowth of bacteria, including Gardnerella vaginitis, an anaerobic bacteria, which disrupts the balance of natural vaginal microbiome and can result in symptoms such as vaginal odor and discharge. Organon, our global collaborator for XACIATO, shares our commitment to advance critically needed innovations in women's health, and we believe that Organon's unique focus on women's health, coupled with their strong commercial capabilities, will ensure that XACIATO reaches the women most impacted by this condition. We believe that Organon is uniquely positioned to bring XACIATO to market and drive patient and provider awareness and utilization of XACIATO based on its unique and differentiated product characteristics. Under our license agreement with Organon to commercialize XACIATO, we received a $10 million cash payment from Organon after the license became effective in June. And we are also eligible to receive potential milestone payments of up to $182.5 million as well as tiered double-digit royalties based on net sales. XACIATO is expected to be available commercially in the U.S. in the fourth quarter of this year. While we are still very…

Thank you, John, and thanks, everyone, for joining us today. I would now like to summarize Dare's financial results for the quarter ended June 30, 2022, which I will refer to as the current quarter or the second quarter of 2022. Dare's business model is comprised of 2 parts. The first is to assemble and advance a portfolio of differentiated product candidates that address meaningful unmet needs that we've identified in women's health. The investment required to do this includes corporate overhead, portfolio acquisition and maintenance costs and ongoing research and development or R&D expenses. The second part of our model involves monetizing the value of our portfolio's clinical and regulatory events over the near and long term. There are many ways to do this and generate value from products with differentiated outcomes and one approach includes securing payments upfront and over time in the form of license fees, commercial milestones and royalties on net product sales. For Dare, this occurred during the second quarter of 2022, when we recognized revenue of $10 million from the upfront license fee due in connection with the closing of our global license agreement for XACIATO with Organon. As my colleagues have mentioned, Dare will be entitled to receive additional milestones and royalties once XACIATO is commercially launched. But back to the current quarter. Our general and administrative or G&A expenses were approximately $2.8 million. Our R&D expenses, which vary from quarter-to-quarter based on our clinical, preclinical manufacturing, regulatory and other portfolio activities were approximately $6.8 million. The current quarter's R&D expenses were actually about $0.5 million less than the comparable period for 2021 and primarily reflected the cost of the ongoing Sildenafil Cream Phase IIb RESPOND clinical trial and manufacturing and regulatory affairs activities related to Ovaprene. We ended the current quarter with…

[Operator Instructions]. And your first question comes from the line of Douglas Tsao with H.C. Wainwright. Your next question comes from the line of Kumar Raja with Brookline Capital Markets.

I'm for Kumar. Can you share any insights updates regarding the trial? Like how are the patients responding, the safety profile? Whatever you can share?

So the VVA1 trial is our Phase I/II study that's going on right now in Australia for our vaginal atrophy program. And just to give you a little more perspective on maybe what that trial is, right, and what we're looking at in that trial. So first of all, that the active that we're studying in that case is actually tamoxifen, which is a -- as I mentioned earlier, a known chemical entity, that is often used as part of a breast cancer treatment regimen, in this case is being delivered vaginally. And the reason why is tamoxifen has a really interesting profile. It acts as an estrogen antagonist in the breast, but an estrogen agonist vaginally. So it makes it a really interesting chemical entity to consider for this condition. And prior to the Phase I/II study, there was actually a proof-of-concept study that was run just using a not necessarily optimally formulated vaginal tamoxifen, but looking at tamoxifen delivered vaginally and specifically in that proof-of-concept study that's been published and they got us really excited about the opportunity. What they showed was some important improvements. So they showed improvements in vaginal pH. So that's often one of the challenges with vaginal atrophy, the vaginal pH rises, and that can lead to other complications in terms of the vaginal microbiome. And also improvement in vaginal dryness. And so since that really exciting proof-of-concept study, what we have done is obviously worked to optimize the formulation. And then in this Phase I/II study, we're actually looking at women -- a cohort of women, including women with a history of breast cancer. And we're actually looking at a number of different treatment groups. So we're looking at 4 different dose levels and placebo. And so these women will be able to…

One more -- one question regarding the -- like could you provide some color to the rate of enrollment in the ongoing HRT1 trial? Like how many sites do you have activated? And do you plan to add more sites to it?

Yes. So the HRT1 study is -- and similarly, is a Phase I/II trial, evaluating our vaginal ring for hormone therapy. We have already completed a Phase I study, which I point out simply because the study that we've already completed is relevant to your question a couple of ways. So first of all, the study that's already been completed with HRT1 really already demonstrated the PK profile and importantly, demonstrated its potential to be effective in both the vaginal atrophy as well as the vasomotor symptoms of menopause because we looked at -- we know the therapeutic dose levels of those hormones. And so that has already been demonstrated. What we wanted to do in this study is give women an opportunity to actually use the product for 3 months in a row with a 28-day vaginal ring. So 3, she'll get to use it 3 different times, 3 different rings over the course of 3 months, and we are looking at the same 2 doses again. It's about 20 women. They are all postmenopausal. So again, these are women that are in menopause. And so similarly to what I talked about with the VVA1 study, we'll be looking at safety, usability, acceptability as well as symptom release data. So very similarly, we're asking them about their most bothersome symptoms of menopause before they come in and then we're going to ask them how they're doing, after 3 months of using the product. So again, not powered for efficacy, but will give us some nice signs. In terms of the site, we do a number of our Phase I studies in Australia, very cost effective, right, because of the Australian R&D cash rebate. And we actually have a few sites, and Australia is not huge. So we have a few sites that we work with across our studies in Australia, so it's the same sites. And as John mentioned in his comments, what we found quite interesting, and I think it says a lot about the product is women who had been in the prior Phase I asked the -- at the end of that study, said, "My gosh, can't we just keep using this? No, you can't. But they asked to be notified of any future study. So many of the participants in this study already had experience with the product because they were in the prior -- prior Phase I study. So we don't need to really add any additional sites. So at this point, we're following the subjects in the trial, and then we expect, as I mentioned, that top line data readout in the fourth quarter.

[Operator Instructions]. There are no further questions. I will now turn the call back over to Ms. Johnson for closing remarks.

Great. Well, thank you so much for taking the time this afternoon to hear about the recent updates and our ongoing commitment to drive value for all of our stakeholders, the women, the health care providers and our shareholders. With our diverse portfolio, we seek to bring to market differentiated prescription therapies that really prioritize women's health and well-being and expand those treatment options where not exist, enhance the outcomes where current standard of care has meaningful shortcomings and improve ease of use for women, where a more compelling form factor can drive adoption primarily in the areas as we've been discussing of contraception, vaginal health, sexual health and facility and where we think there are really compelling market opportunities. Today, we have 7 candidates in various stages of development and 1 FDA-approved product expected to be launched commercially in the fourth quarter of this year. So we look forward to keeping you updated on our progress against the important 2022 objectives and milestones we set for all of our candidates under development as well as the activities with Organon regarding the XACIATO launch. So thank you for tuning into the call today and for all of your support.

This concludes today's conference call. You may now disconnect.