Daré Bioscience, Inc.
Q2 2019 Earnings Call Transcript

Published: 15 Aug 2019

[Operator:]

Welcome to the conference call hosted by Daré Bioscience to discuss financial results for the quarter ended June 30, 2019, and to provide a general business update. This call is being recorded. My name is Joel, and I will be your operator today.With us today are Sabrina Martucci Johnson, Daré's President and Chief Executive Officer; Lisa Walters-Hoffert, Daré's Chief Financial Officer; Dr. Christine Mauck, Daré's Medical Director; and Dr. David Friend, Daré's Chief Scientific Officer.Ms. Johnson, please proceed.

[Sabrina Martucci Johnson:]

Thank you and welcome to our financial results and business update call for Daré Bioscience. It's a pleasure to have the opportunity to talk about our second quarter results and Company highlights as well as our upcoming milestones for the remainder of 2019 and 2020.Before we begin, I'd like to remind you that today's discussion will include forward-looking statements within the meaning of 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 historic fact 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, 2018, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, 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 14, 2019. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.Daré is a Biopharmaceutical Company focused squarely on improving the life and well-being of women, primarily in the areas of contraception, vaginal health, sexual health and fertility. We're delivering on our vision of becoming the premier accelerator of innovation in women's health as we now have [technical difficulty] at various stages of the development continuum and across multiple therapeutic areas.For today's call, we will focus on our three later stage clinical product candidates; DARE-BV1, Ovaprene and Sildenafil Cream, 3.6%. Before we address each of these product opportunities, I do first want to take a moment to publicly acknowledge our Former Board Chair, Roger Hawley.Roger co-founded Daré and continues to be one of our biggest champions and he is still our largest individual shareholder. His support and guidance have been integral to the transformation of Daré from a one product, mid-stage, clinical development company to a uniquely positioned innovation accelerator with a highly diversified portfolio of differentiated product candidates.I am both personally and professionally grateful for all of his support and counsel over the last four years. And we are in a very fortunate position as we have gone from strength to strength as it relates to our Board Chair. Our new Board Chair, Bill Rastetter is a Veteran of the Biotech Industry and has been instrumental in leading companies to clinical, strategic partnering and commercial success.He has served as the Chief Executive and Chairman of the Board of numerous companies and he is also an active advisor to Investment Bank. Among his accomplishment, Bill served as a Chairman and CEO of IDEXX Pharmaceuticals and was instrumental in leading the multi-billion dollar merger of equals between IDEC and Biogen.He was Chairman of Illumina from 2005 to 2016 and was also Chairman and co-founder of Receptos, which was acquired by Celgene in 2015 for $7.2 billion. Rastetter holds a Ph.D. and a Masters of Arts in Chemistry from Harvard University and a Bachelor of Science in Chemistry from Massachusetts Institute of Technology. We are honored to have Bill help guide Daré through our next stage of growth and development.I’d now like to use the balance of the call to highlight our progress and focus specifically on our most advanced product candidates, DARE-BV1, Ovaprene and Sildenafil Cream. The first product candidate I'll discuss is DARE-BV1 for the treatment of bacterial vaginosis.On our last update call, we communicated that we are preparing an investigational new drug application or IND, for DARE-BV1 and that we would file the IND with the U.S. Food and Drug Administration or FDA in the second half of the year in order to commence a Phase III clinical study for DARE-BV1.I'm pleased to report that we remain on track to submit the IND and start our Phase III study before the end of 2019. Following the completion of the Phase III study and approximately 250 women and assuming a successful outcome, we will seek to file a new drug application with the FDA in 2020.We also announced on Monday of this week that DARE-BV1 has been granted Qualified Infectious Disease Product or QIDP designation by the FDA for the treatment of bacterial vaginosis in women.QIDP designation is available under the Title VIII of the Food and Drug Administration Safety and Innovation Act titled Generating Antibiotic Incentives Now or GAIN, which creates incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections.The primary incentive is a five-year exclusivity extension added to any exclusivity for which a QIDP qualifies upon FDA approval. Additionally, DARE-BV1's QIDP designation makes it eligible for Fast Track designation and Priority Review.Dr. Dave Friend, our Chief Scientific Officer is leading the BV program internally and I'll ask him to provide a bit of color on our scientific communication strategy and share some insights into the reaction you've received from the scientific community specific to DARE-BV1.For those have been following the Company, we will appreciate that we have been very active in both the scientific and medical communities with a variety of posters, publications and abstracts.And I'll let Dave give you some additional detail on this as well. Dave?

[David Friend:]

Thank you, Sabrina. With respect to our DARE-BV1 program, we're excited to be moving this program into what we believe will be at single Phase III registrational trial and we're very active behind the scenes working with our partners on operationalizing, the clinical study and producing study supplies.Given the challenges in treating bacterial vaginosis, the reactions from the scientific and medical community to our product candidate have been very positive. I recently presented an abstract at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology, highlighting the investigator initiated proof-of-concept study for DARE-BV1. That led to our interest in the program and the data were well received.I presented the summary of the trial design inclusion criteria and topline findings from that investigator initiated study and found that there was a lot of enthusiasm for the product, particularly given the 86% clinical cure rate in a valuable patients seen at the day 7 to 14 visit, also known as a test-of-cure visit.Most physicians there were very familiar with BV and many express frustration with the marginal effectiveness of currently marketed products, particularly when delivered vaginally. If successful, we expect that the DARE-BV1 would become a welcome to new addition to the treatment armamentarium and a potential frontline option for the treatment of BV.As it relates to our broader scientific communication strategy, we continued to publish and present findings of our portfolio programs and scientific meetings and those submissions and presentations have been well received. In fact, we were recently awarded Best Abstract by the American Association of Pharmaceutical Scientists for our abstract highlighting vaginal tamoxifen as a potential new treatment option for vulvar and vaginal atrophy in a hormone receptor-positive breast cancer population.Other scientific and development updates are anticipated during the second half of this year, including our Ovaprene topline data readout in the fourth quarter. We will be sharing those updates with the investor and scientific communities when they become available.With that, I'll turn it back over to Sabrina.

[Sabrina Martucci Johnson:]

Thank you, Dave, and congratulations to you and your team for all of your hard work and well earned success. It's time to turn our attention to our exciting pre-pivotal product candidate, Ovaprene. Ovaprene is a novel vaginal ring that has the potential to disrupt the contraceptive space by being the only monthly non-hormonal woman-initiated contraceptive approved by the FDA.Ovaprene is designed to be used on a cycle-by-cycle basis, just like NuvaRing, giving women great flexibility and control, with the potential for efficacy, comparable to short acting hormonal methods, including products like NuvaRing without the use of hormones. We recently communicated that we had completed enrollment in the postcoital test study, or PCT study and that we are on track to have topline data in the fourth quarter.With us today is Dr. Christine Mauck, our Medical Director supervising the Ovaprene PCT study. I'd ask Christine to provide us with an update on the PCT study.And with that, I'll turn it over to you, Christine.

[Christine Mauck:]

Thank you, Sabrina. Let me start off by saying that I've worked in Reproductive Health for many years and I've seen a wide variety of contraceptive products throughout my career. I've been involved in the program design and the clinical trials of a number of FDA approved birth control options. We got particularly excited about Ovaprene was the idea of something that is non-daily, hormone-free and women controlled. It's really challenging to find all three of those attributes in a single contraceptive option, which is why I think Ovaprene is such a compelling potential new addition to the field of contraception.Specifically Ovaprene is designed to provide a contraceptive effect consistent with the most effective barrier option, the diaphragm and commonly used short-acting hormonal options, such as contraceptive pill, patches and vaginal ring which provide 88% to 91% effectiveness in normal use also known as typical use.Today, hormone-free contraceptive products fall into two categories. The first category must be use at or shortly before intercourse, includes diaphragm, condoms, spermicides and multi-purpose gels and shows lower typical use contraceptive effectiveness as compared to hormonal methods. The second non-hormonal category includes long-acting copper IUDs, which while effective, must be administered by a physician and hence are not women controlled. If approved, Ovaprene would fill a gap in the current contraceptive mix.With respect to the PCT study, as Sabrina mentioned, we are on track to have an announced topline data in the fourth quarter. We're pleased with the trial operations, site and subject participation and the overall quality of the data being generated. We are fortunate to have some of the top reproductive health sites in the country participating in this study including Eastern Virginia Medical School, the Oregon Health & Science University, and the University of Pennsylvania. These institutions are known for their deep expertise in women's health and for conducting high quality clinical trials. We're delighted that they're participating in the study.Ovaprene has already been through a smaller version of this study and those findings were positive so we're encouraged to conclude our PCT study and share those results with you when they become available. If the current PCT study demonstrates less than five progressively motile sperm per high powered field in the cervical canal in most women and that Ovaprene can be safely worn over multiple weeks, we intends to prepare and file an Investigational Device Exemption with the FDA to commence a pivotal contraceptive clinical trial in women at risk for pregnancy in 2020.Our expectation at this point is that a successful pivotal clinical trial could support marketing approvals of Ovaprene in the United States, Europe, and other countries worldwide.And with that, I'll turn it back over to Sabrina.

[Sabrina Martucci Johnson:]

Thank you, Christine. And I'd like to acknowledge the work and the full clinical operations team with respect to our PCT trial. Their collected efforts have enabled us to hit our critical enrollment and PCT cycle targets to date. Thank you, Christine.Finally, I want to speak about our third later-stage product candidates Sildenafil Cream, which is being developed for the treatment of Female Sexual Arousal Disorder, also known as FSAD. We are in the final stages of completing our non-national content validity study that we [technical difficulty] the general arousal symptoms that will serve as the basis for the FSAD patient reported outcomes or PRO tool, which will be used to facilitate the diagnosis of and importantly the assessment of treatment effectiveness for FSAD in our Phase IIb as well as our Phase III studies.In our view, completing this study will be a significant derisking because it will position us to hold a Type C meeting with the FDA [technical difficulty] specific timing for moving into the at-home dosing stage of the Phase IIb program.Before I turn the call over to Lisa, I'd like to reiterate that we believe each candidate portfolio [technical difficultly] as well as those who've been discussed, has the potential to become either a first-line therapy or a first-in-category position or both and to deliver on our mission persistent at unmet need in the women's health.I'll now turn the call over to Lisa, our CFO to review the financials.

[Lisa Walters-Hoffert:]

Thank you, Sabrina, and thank you all for participating today on this update call. I would like to summarize Daré's results for the second quarter of 2019. As previously noted, Daré's primary activities have been and will continue to be research and development activities to advance our product portfolio through value inflection and clinical milestones. As such, our financials consist primarily of general, corporate overhead expense, costs related to acquiring and maintaining our product candidates and research and development expenses.During the quarter ended June 30, 2019, Daré's general and administrative expenses were $1.3 million, and our research and development expenses were $2.5 million. As the team just discussed, most of our R&D expenses reflect the costs related to the Ovaprene, PCT clinical trial and the content validity study for Sildenafil Cream 3.6% program and to a lesser extent work that we're doing on DARE-BV1 and DARE-HRT1.Our comprehensive loss for the quarter was $4.7 million of which $790,000 represented non-cash deemed dividend related to the reduction of the exercise price of certain of our outstanding warrants.We ended the second quarter of 2019 with cash of approximately $5.6 million, 16.7 million common shares outstanding, approximately $3.7 million warrants to purchase shares of our common stock and no debt.The underwritten public offering we completed in April generated net proceeds of approximately $5.2 million and put us in a position to execute on the development plans and programs during the second half of 2019 that Sabrina just described.We believe our cash at June 30 together with funding from our existing NIH grant, which serves to offset Ovaprene clinical development expenses will be sufficient to fund our planned operations into the first quarter of 2020.And while we believe we are capital efficient as we executed in our planned operations and move our clinical candidates forward, we will need to raise additional capital. We intend to continue to explore multiple options including, but not limited to grant and foundation funding, collaboration agreements, strategic partnerships, and the issuance of equity.I would now like to turn the call back over to Sabrina.

[Sabrina Martucci Johnson:]

Thank you, Lisa. The first half of 2019 has been transformational for Daré and we believe we're well positioned to continue to create and capture value from our portfolio of women's health product candidates. We're encouraged and excited with the level of interest and activity as it relates to our strategic partnering efforts.And we look forward to keeping you updated on the clinical and regulatory milestones expected in the second half of 2019 from DARE-BV1 in bacterial vaginosis from my non-Daré hormone-free contraceptive candidate Ovaprene and provide first and category treatment opportunity for FSAD program.Together with our Phase I clinical stage and pre-clinical assets, these programs constitute arguably the most differentiated portfolio in women's health. And one that we believe is well positioned to drive significant value in both the short and the long-term for investors and most importantly for women.We'll now turn it over to the operator who opened the lines for Q&A.

[Operator:]

Thank you for attending the conference call. [Operator Instructions] Our first question comes from Yasmeen Rahimi with ROTH Capital Partners. Your line is now open.

[Yasmeen Rahimi:]

Hi, team. Thank you for the updates. Congratulations on QIDP. So two questions for you, question one is, can you remind us what are the components of the BV pivotal trial that are [indiscernible] remain for debate? And then the second question is on the postcoital test. Can you walk us sort of through what are your expectations are and then followed by walk us through how filing with the device division differs from the traditional FDA pathway that in all – in relation to the contraception drug development? That would be very helpful. Thank you.

[Sabrina Martucci Johnson:]

And so for the BV, bacterial vaginosis program [technical difficulty] as it relates to bacterial vaginosis and our program will of course very much aligned with that in terms of evaluating women at the day 7 to 14 visit as well as the day 21, which is very consistent with the draft guidance. And so from a trial design perspective, following that guidance document in terms of the bare minimum of what's required for the program.Some of the things that [technical difficulty] given the really interesting findings that came out of the investigator initiated study and particularly that cure rate of 86%, which is higher than what's been seen other that treatments, and historically is [technical difficulty] some additional data in the [technical difficulty] none of what's required for approval that might help guide physicians on what to expect on the treatment that [technical difficulty] cure rate than what's been available historically, vaginally.So as we continue to refine that, as we've mentioned before, we've been in discussions with potential strategic partners around the program, particularly as it relates to that Phase III and the design of that Phase III, we will provide some additional updates before the study starts that from a bare minimum that gives you a perspective. These are relatively short studies and you're really only following women for about a month because this is an acute treatment.And as it pertains to Ovaprene and postcoital test study with Ovaprene as Christine mentioned, the primary endpoint is looking for less than five progressively motile sperm, and we know from historic postcoital test studies for products that have gone on to do a contraceptive pivotal effectiveness study similar to what we would anticipate doing next.That does studies those products, which is [technical difficulty] products that have shown less than five progressively motile sperm, those products have gone on to have typical use pregnancy effectiveness rates of 86% to 91%. So right in that range of the hormonal short-acting methods like Christine was talking about.And in terms of your question from a regulatory perspective of – with the device division leading the review of Ovaprene, how is that different from what one might have expected with the drug division of the FDA, basically the device division of the FDA there's a few things to keep in mind.One is, postcoital test becomes an important – of our IDE, which is the IND equivalent essentially for the device division of the FDA. So we actually will be filing our IDE pending successful completion of this postcoital test study. So that next step would be to file and submit the IDE. And then in terms of what the device division typically looks for [technical difficulty].

[John Fair:]

Hi, everyone. This is John Fair with Daré, Chief Business Officer. Sabrina is actually on the road, so her phone is breaking up a little bit. I'm going to try to just fill in the gaps on that last answer you guys mean. So the other two components of going to CDRH pathway versus the CDAR pathway is the size of the trial will likely be smaller to our belief, 250 women and a single phase, a single arm study, and that the length of the trial is likely going to be shorter as well. So likely seven cycles or six months versus your traditional 13 cycles or one-year study for a CDAR.

[Yasmeen Rahimi:]

Awesome. Thank you.

[Sabrina Martucci Johnson:]

Thank you, John. That was helpful thing.

[John Fair:]

You're welcome.

[Operator:]

Thank you. And our next question comes from Jason Kolbert with Dawson James. Your line is now open.

[Jason Kolbert:]

Thank you so much. I have several questions across several areas. I want to pick up on what Rahimi was talking about in terms of kind of the approval pathway, but very briefly, can you just talk with me about, you laid out some catalysts in the press release and I want to make sure I get them dialed in precisely. And I'd like to understand given the tightness of the cash balance, are you looking at other sources of capital partnerships in BD in terms of extending the runway? Why don't we deal with the finances first?

[Sabrina Martucci Johnson:]

Yes. This is Sabrina, and John definitely jump in if I break up.

[Jason Kolbert:]

It's made the call really tough by the way because you're cutting in and out a lot, but so what?

[Sabrina Martucci Johnson:]

Yes. Well thank you for letting me know. So I'll enter briefly and then obviously, John and team follow-up if necessary. But in terms of financing strategy, so first of all, as Lisa mentioned, we look at multiple sources of capital as we think about financing the company and importantly given the catalyst that we have coming up, we're also in a very different place as it pertains to investor interest in the company given the late-stage portfolio and the number of upcoming milestones as well as interest from strategic potential partners. And so as we think about financing the company, that really creates a lot of optionality for us and really gives us a lot of flexibility to think about getting the best [technical difficulty] from equity financing…

[Jason Kolbert:]

Sorry, you broke up that we lost you like the last minute there.

[Sabrina Martucci Johnson:]

All right. John, do you want to pick up on that and Lisa?

[John Fair:]

Yes, for sure. Thanks Jason. Yes, so I think we're broadly speaking, we feel very comfortable, very odd relative to those catalysts that we've identified in terms of the cash runway and being able to get to the end of our PCT study with a full data readout which you think is a very big catalyst for the company and a value driver. In terms of getting DARE-BV funded and underway and study initiation study start. We feel very comfortable with that.And so of course we've guided, we're finishing our content validity program and we're getting ready to move into the Phase IIb at-home. So we feel very comfortable with achieving those catalysts based on what's currently available to us. And then to kind of dovetail on what Sabrina was saying because of these, we think really value driving catalyst in the very near future, we have a lot of optionality as relates to attracting more capital to the company and maybe I’ll ask Lisa to make some comments around that.

[Lisa Walters-Hoffert:]

Yes. And I just really did kind of reiterate what Sabrina said; with so nice about our portfolio is it does lend itself to a variety of different types of financings. One is of course, the sale of equity, which we have done opportunistically over the last couple of years.Also as John and Sabrina have said, as these candidates advanced and we have additional data and also color and clarity on clinical development and makes them more attractive to potential partners. And then last but not least, I'm a big fan of grant funding. It's a wonderful way to keep the portfolio moving ahead in a non-dilutive way to shareholders. So rest assured as a CFO, we are looking at all three options constantly and trying to figure out the best path forward for shareholders.

[Jason Kolbert:]

And can I ask a kind of sensitive question because you really are dedicated to women's health and Ovaprene, not just Ovaprene, but FSAD has the potential to kind of change the paradigm. How timely is this and does that matter? I mean in the era of the MeToo Movement, is that something that could potentially impact partnering?

[John Fair:]

Yes. So I'll start on that. I think you've hit the nail on the head. I really think we are at the right place at the right time when it comes to bringing these really novel products to market, especially in areas where we think there's still persistent unmet needs.So even in contraception, there's a tremendous amount of options and variety out there, but there's still a lot of unmet need, especially when you're looking at a hormone-free option and a hormone-free option that can deliver an effectiveness number that's getting close to the hormone-based options and something that's non-daily that's under her control. These are all things that your to point really play into.Women's empowerment really being able to control her fertility on her time and her schedule and the way that she wants. As it relates to FSAD, we think there is a tremendous just untapped market there and there's an unmet need for sure. There is no FDA approved product for this segment and we believe if we're successful, this is going to be a very important product for women.We've looked at the data in incidence and prevalence and FSAD, which is analogous to erectile dysfunction in men, is as big as an opportunity as it is in the male population. So that means there's a lot of women now kind of suffering with symptoms and not having great therapeutic interventions to really address those symptoms. So we agree with you 100%. This is the – we are at the right place at the right time.

[Jason Kolbert:]

Okay. Thanks John. And one last question regarding the QIDP designation and its linkage to Fast Track and Priority Review status, can you help me understand what the next steps are to kind of get that on? Because it seems to me that would be something that would make the product even more attractive to a potential partner?

[John Fair:]

Yes, agreed. And we were very, very – go ahead Sabrina. It sounds like you're back.

[Sabrina Martucci Johnson:]

Well, I'm hopefully back. I was just going to say, yes. So, basically as we proceed through the regulatory process, those are the things that will be available to us. As we file the IND and then the NDA that's when some of those things can be formally granted. But having the QIDP status basically makes us eligible for them. So we are super excited about them because to your point, Jason, that definitely makes it a more interesting product that as well as the additional five years of exclusivity to potential partners.

[Jason Kolbert:]

So Sabrina, what you're saying is that there's some bureaucratic dotting of i's and crossing of t's, but provided everything comes together, you should essentially receive Fast Track and Priority Review designation.

[Sabrina Martucci Johnson:]

Correct. That is our understanding.

[Jason Kolbert:]

Okay. Thanks guys. Really it's great to see all the progress. I am so happy the following this Company. Thank you so much.

[John Fair:]

Thanks Jason.

[Sabrina Martucci Johnson:]

Thank you.

[Christine Mauck:]

This is Christine. If I can interject, I got cut off and I am back on. I apologize.

[John Fair:]

Thanks Christine.

[Sabrina Martucci Johnson:]

Okay.

[Christine Mauck:]

Thank you.

[Operator:]

Thank you. And our next question comes from Jason McCarthy with Maxim Group. Your line is now open.

[Joanne Lee:]

Hi, good afternoon. This is Joanne Lee on the line for Jason. Thanks for taking my questions and congratulations on a great progress this quarter.

[Sabrina Martucci Johnson:]

Thank you.

[Joanne Lee:]

So my first question is on the Phase IIb trial for Sildenafil. Could you give us some more granularity on the trial design, namely patient's size, eligibility criteria and et cetera, and following that, could you share some color on the patient reported outcome measurements that are being utilized to assess efficacy in FSAD?

[Sabrina Martucci Johnson:]

Yes, sure. This is Sabrina. I'll start and obviously if I get cut out again team will jump in. But in terms of the Phase IIb design that's something we're still working through with FDA because as you can imagine [technical difficultly] outcome the end point is really…

[John Fair:]

Yes. So I'll pick up on that Joanne. So that we have not publicly disclosed the design of the Phase IIb because again this is a – since it's a new area and it's essentially a new domain for the agency, we want to make sure that we have great alignment around the PRO tool that we're going to be bringing into that at-home section, the Phase IIb section, as well as the Phase III.So we have not disclosed that yet, but as when we're able to, we will for sure. And then in terms of the PRO just know that we are working very hard to develop a very specific PRO for FSAD. So that actually addresses the signs and symptoms and most meaningful and most bothersome symptoms of FSAD as it relates to women who are in the category. That is also – in the tool or a process by which we need to review with the FDA and get greater alignment and clarity before we move that one forward. So again, we have not disclosed exactly what the PRO components are at this point.

[Joanne Lee:]

Okay, great. And what will be the timeline surrounding the Phase II trial? Could we expect topline data for the content validity component in the third quarter and how soon after the study's completion will the second Type C meeting with the FDA take place?

[Sabrina Martucci Johnson:]

Yes. I can carry on that. So in terms of timing we are definitely updated as we mentioned today when the final stages of that study. So as soon as we can, we'll update on the completion of that. And the FDA with them last Type C meeting already agreed to this next Type C meeting. So really it will just be a matter of finalizing the results and getting in front of them. But as soon as we have clarity and information, we will definitely be providing it. But based on our current expectations we believe that we are still on a task that could allow us to start the study this year. But as soon as we have more information we will definitely provide it.

[Joanne Lee:]

Great. Thank you. And my last question is related to Ovaprene. There are some clear differences between Ovaprene and hormonal based options in the contraceptive space, which could have a significant impact on the design for the upcoming pivotal trial. Could you explain to us how would these differences be beneficial for Ovaprene?

[Sabrina Martucci Johnson:]

Yes. John, do you want to start – I can start, but if I cut up again, just jump in, right.

[John Fair:]

You should start.

[Sabrina Martucci Johnson:]

Perfect. Okay. So in terms of the design of the study is [technical difficulty] the main differences is really duration of study, our expectation is and size, so fewer subjects and shorter duration of study [technical difficulty] in terms of primary endpoint. You're still looking at pregnancy rates.That is what you look at in the contraceptive studies and with a product like Ovaprene, it's once a month products from a compliance perspective of what she has to do in the study, it's just once a month. She inserts it [indiscernible], she leaves it in place until her next menstrual cycle and remove that.And so that definitely helps you not only in the real world, but also from a clinical trial perspective. So some of those nuances will definitely make a difference as we're conducting the clinical study because the burden on the subject from a product use perspective is less than what she might be accustomed to if she was participating in a different study.

[Joanne Lee:]

Great. Thank you for walking us through that. And again, congrats on the progress.

[Sabrina Martucci Johnson:]

Thank you.

[Operator:]

Thank you. And our next question comes from Jim Molloy with Alliance Global Partners. Your line is now open.

[James Molloy:]

Hey, guys. Thanks for taking my question. My apology if this has been asked already, I’m bouncing between a couple call. But on the FSAD, I think [indiscernible] this one actually. I was wondering about the questionnaire and what details can you give on sort of the final – have you come down to the final questions and that sort of thing? Is that something we have to wait for the meeting with the FDA?

[Sabrina Martucci Johnson:]

Yes. You'll have to wait for the meeting with the FDA, and I’ll say that even though we maybe a little coy because we really feel like it's a competitive advantage to have gone through this process with the FDA. And so we're not going to give all the details out.But we can say is that as John mentioned, is very much focused on the general sensations that are available. So what are some of those bothersome symptoms when it comes to those general sensation arousal? What is she most concerned about? What is she very in tune with? And we want to make sure those are the symptoms that we're capturing.So again, the general symptoms that would likely be mediated by blood flow, because that's what Sildenafil does. And we want to make sure we're capturing her most bothersome of those symptoms. So that's really going to be core of what we've been looking at in a content validity.

[James Molloy:]

Got it. Thank you for that. And then on the – I know you guys are – obviously number of programs are ongoing. We've got a pretty deep bench of preclinical things. What would be potentially next? Should you have enough money or enough capital to sort of run the next trials? What would be the next couple that you guys be looking at potential advance next into sort of Phase I?

[Sabrina Martucci Johnson:]

Yes. Thanks for that question and thanks for appreciating that. We do have a great bench in terms of our preclinical portfolio. And what's really exciting about a number of those programs is that while they're preclinical, they're leveraging the 505(b)(2) regulatory pathway. And as a result can advance fairly quickly into that clinical phase.And so really next up to think about would be our HRT1 program, which is our hormone replacement program. It's the first ever 28-day vaginal ring with both bio-identical estradiol and progesterone together in one ring. So it's really the only product right now in development is delivering those hormones for hormone replacement in the way that menopause society and the medical institutions recommend. So we are excited to move that into a Phase I and we're working towards initiating that this year.And then our vaginal atrophy program for breast cancer survivors for vaginal atrophy in that population or vaginal tamoxifen as well as our fertility vaginal ring, FRT1 with bio-identical progesterone. Both of those are just teed up in terms of manufacturing activities, so that we can look for advancing those into the Phase I clinic next year. So those are really our goals with those programs in terms of the next year that will be moving into the clinic.

[James Molloy:]

Great. Thank you for taking the questions.

[Sabrina Martucci Johnson:]

You bet.

[Operator:]

Thank you. And our final question comes from Brian Marckx with Zacks Investment. Your line is now open.

[Brian Marckx:]

Hi, everybody. I apologize if you've addressed these also in between calls. Relative to the Ovaprene and the PCT study just kind of wanting to get a status update. You put out a press release on June 26, I believe in it, use the language “completed recruitment.” So just wanted to get some clarification on – does that mean that the final patient or what you expect to be the final patient has enrolled in the study and actually began the study?

[Sabrina Martucci Johnson:]

Yes. That’s a great question. So the way the study works, obviously we go through recruitment like everyone does. But one of the very important factors in participating in this study is that the couple has to demonstrate that enough [technical difficultly] presence of any product can make it into the cervix. And so that's actually a criteria for enrollment. So completing recruitment, we completed basically getting all the patients in the queue.Some of those subjects will have dropped out and did drop out because they just didn't demonstrate and that’s sperm at their baseline assessment. But those of them that did, yes, they were enrolled in the study. So at this stage, we're basically taking all the subjects through all of the assessments they go through.It's actually five cycles of assessment, including that baseline. That's the criteria for them to actually get to participate. And based on that timing, that's how we feel confident that we're going to have data in the fourth quarter.

[Brian Marckx:]

Okay. And Sabrina, I think you had mentioned before that you expect 25 couples, I believe in the study.

[Sabrina Martucci Johnson:]

Yes.

[Brian Marckx:]

What is the – just given that this is a PCT study is somewhat non-conventional as it goes for just a typical drug or device study, just the design. Does that increase – potentially increase the risk that the dropout rate maybe higher. And then relative to that as well, do you have to over enroll to get to 25 or is 25 not – do you need less than 25 couples, I guess for – to have this sufficient data at the end?

[Sabrina Martucci Johnson:]

Sure. Great question. So typical PCT study are in the range of 15 to 30, so targeted [technical difficultly] but it doesn't have to be 25. The 25 is what we targeted. And generally in contraceptive studies and definitely in PCT study, the highest dropout rate, then you may see in other therapeutic areas.So sometimes as high as 50% drop out rates. So that's definitely conservatively what we wanted to plan for so that we could comfortably ensure that our goal is 25. We're really looking for somewhere between 15 to 30.Women completing both [technical difficultly] she actually goes through two different Ovaprene PCT assessment is actually much more robust than done with any other product. So we are targeting 25 completing both, but really the goal is kind of in that 15 to 30 range.

[Brian Marckx:]

Okay. All right. Thank you very much.

[Sabrina Martucci Johnson:]

Yes. Thank you. Great question.

[Operator:]

Thank you. This concludes today's question-and-answer session. I’d now like to turn the call back over to Sabrina Martucci Johnson for closing remarks.

[Sabrina Martucci Johnson:]

Well, thank you. And thank you everyone for taking the time this afternoon. And apologies if my mime was a little bit structured for part of the call. We really do appreciate the opportunity to give the update and definitely look forward to keeping you updated on our progress this year. Thank you.

[Operator:]

Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program and you may all disconnect. Everyone have a wonderful day.