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Edited Transcript of DARE earnings conference call or presentation 14-May-19 8:30pm GMT

Q1 2019 Dare Bioscience Inc Earnings Call

Cambridge May 28, 2019 (Thomson StreetEvents) -- Edited Transcript of Dare Bioscience Inc earnings conference call or presentation Tuesday, May 14, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Lisa Walters-Hoffert

Daré Bioscience, Inc. - CFO

* Sabrina Martucci Johnson

Daré Bioscience, Inc. - President, CEO, Secretary & Director

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Conference Call Participants

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* Brian W. Marckx

Zacks Investment Research, Inc. - Director of Research and Senior Medical Technology, Medical Device & Diagnostics Analyst

* Jason Wesly McCarthy

Maxim Group LLC, Research Division - Senior MD

* Rachel Yang

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Presentation

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Operator [1]

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Welcome to the conference call hosted by Daré Bioscience to provide financial results for the quarter ended March 31, 2019, and a general business update. This call is being recorded. My name is Towanda, and I will be your operator today.

With us today is Sabrina Martucci Johnson, Daré's Chief Executive Officer; and Lisa Walters-Hoffert, Daré's Chief Financial Officer. Ms. Johnson, please proceed.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [2]

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Great. Thank you. Welcome to our financial results and business update call for Daré Bioscience. It's a pleasure to have the opportunity to talk about our first quarter results and our company highlights and upcoming milestones in 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 March 31, 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, May 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. Our vision is to become the premier innovation accelerator in women's health and to achieve this goal by identifying, unlocking and advancing candidates with potential to be first in category, address persistent unmet needs and promote a better quality of life for women.

We ended 2018 with a differentiated portfolio that we believe is well positioned to drive upside value by targeting areas where large numbers of women have needs that are not being sufficiently addressed and where true innovation will be rewarded. 2019 is focused on executing against a number of clinical and regulatory portfolio milestones, and I'm excited to discuss in more detail with you today the progress we've made during the first 4 months of the year and some of the milestones we expect in 2019 and 2020.

The first quarter was an active one for Daré and position us well for the year ahead. We believe our differentiated product candidate portfolio is well poised to drive value in 2019 and 2020 as we seek to execute against clinical and regulatory milestones, particularly with our Phase III and Phase II candidates. During the first quarter, we continued enrollment in the postcoital test clinical trial of Ovaprene, our monthly nonhormonal contraceptive candidate. And we remain on track to report top line data in the second half of 2019. In addition, work continued on the content validity patient-reported outcome study of Sildenafil Cream, 3.6%, positioning us to request a Type C Meeting with the FDA later this year at which we intend to obtain its guidance on the end points for our Phase IIb and Phase III clinical trials for female sexual arousal disorder. And finally, activities related to the clinical supply and regulatory requirements of our single-dose potential treatment for bacterial vaginosis, DARE-BV1, are underway to support initiation of a Phase III trial later this year.

We had an opportunity to attend the recent annual conference of the American College of Obstetricians and Gynecologists, or ACOG. So as we review for you our upcoming 2019 portfolio milestones, we will also share some of the important themes that came out of that meeting that highlight the relevance of those persistent unmet needs and how our portfolio candidates are uniquely poised to address them.

I'll start with our Phase III program in bacterial vaginosis, and then we'll provide an update on our Phase II programs, our nonhormonal monthly contraceptive, Ovaprene, and our Sildenafil Cream for the treatment of female sexual arousal disorder. I will wrap up with an overview of our Phase I and pre-Phase I programs in hormone replacement HRT1 and fertility FRT1 and treatment of vaginal atrophy in a hormone receptor-positive breast cancer population, VVA1.

As many of you know, bacterial vaginosis, or BV, is an underdiagnosed clinical condition characterized by a shift in vaginal flora that causes a rise in vaginal pH and symptoms that range from none to very bothersome. So why is it important to effectively treat BV? Well, the health implications of BV include, but are not limited to, increased susceptibility to sexually transmitted infections and preterm birth. The Centers for Disease Control and Prevention estimates that 1 million pregnant women get BV each year. Pregnant women are at an increased risk for BV because of hormone changes that happen during pregnancy. If a woman has BV during pregnancy, her baby is at an increased risk for premature birth and low birth weight. Being born too early or too small can cause health problems for the baby. BV also can cause pelvic inflammatory diseases, also called PID. PID is an infection in the uterus that can increase a woman's risk of infertility or not being able to get pregnant. Unfortunately, with clinical cure rates ranging from 37% to 68%, current FDA-approved prescription drugs for BV are not optimal. Thus, there's a significant opportunity for upside and market expansion and, importantly, for improved outcomes for women.

DARE-BV1 is our Phase III product candidate in development as a treatment for BV. With the addition of DARE-BV1 to our portfolio, we've expanded the reach of our portfolio to address this persistent unmet need in the area of vaginal infections. DARE-BV1 is a single-administration proprietary thermosetting bio-adhesive gel containing the antibiotic clindamycin. In our planned Phase III program, if we're able to demonstrate a clinical cure rate consistent with the 86% cure rate generated in a previously conducted investigator-initiated pilot study, DARE-BV1 has the potential to become a frontline intervention for the treatment of BV. The CDC reports that BV is the most common vaginal infection in women ages 15 to 44. The prevalence of BV is estimated to be approximately 21 million women in the ages 14 to 49.

Daré is preparing our investigational new drug application, or IND, for DARE-BV1, which we will need to file with the U.S. Food and Drug Administration, or FDA, in order to commence a Phase III clinical trial of DARE-BV1 as planned by the end of 2019. This timing also gives us an opportunity to seek trial design feedback beyond the minimum requirements for FDA approval from key opinion leaders and the potential commercial partners that have already expressed interest in the program.

Following completion of the Phase III study of DARE-BV1 in approximately 250 women and assuming a successful outcome, we will seek to file a new drug application with the FDA in 2020. We believe that the addition of DARE-BV1 to the portfolio has moved us into a leadership position in an area of great concern for both women and health care providers.

The next product candidate I want to discuss is Ovaprene. Ovaprene is a novel vaginal ring that has the potential to disrupt the contraceptive space by being the only monthly nonhormonal 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 comparable efficacy without the use of hormones.

According to Global Market Insights 2017 report, the global market size in 2024 for the nonhormonal on-demand category of condoms and diaphragms alone is expected to reach $15 billion, which we believe reflects the growing preference for nonhormonal contraceptive methods.

The Ovaprene postcoital test, or PCT, clinical trial is proceeding as expected, and top line data are expected in the second half of 2019. In advance of that data readout this year, we want to take a moment to provide some perspective on the history of PCT studies and how they can help predict ultimate contraceptive effectiveness so that you're prepared for our upcoming data readout.

The PCT study has been used as a surrogate marker for contraceptive effectiveness. Based on the infertility research that demonstrated the range of motile sperm from greater than 1 to greater than 20 per high-powered field is associated with higher rates of pregnancy. Less than 5 progressively motile sperm per high-powered field is considered reflective of contraceptive effectiveness, and this is the criteria we've used in our Ovaprene study.

Following a successful PCT study is the pivotal study evaluating pregnancy prevention, demonstrating a product's contraceptive effectiveness. In terms of a contraceptive effectiveness assessed in pivotal studies that followed historic PCT studies for other nonhormonal product candidates, for those that exhibited success in their PCT study, uniformly exhibiting below 5 progressively motile sperm per high-powered field, 6 months typical-use effectiveness rates in preventing pregnancy varied from 86% to 91%. To provide some perspective, popular short-acting hormonal contraceptive methods, such as the birth control pill and NuvaRing, have 12 months typical-use effectiveness rates of 91%. Thus, if history is predictive, a nonhormonal product candidate that performs well in its PCT study should go on to generate typical-use effectiveness rates in the pivotal study that are considered highly effective.

If the Ovaprene PCT trial is positive, we intend to prepare and file an investigational device exemption, or IDE, with the FDA in order to commence a pivotal pregnancy prevention clinical trial with Ovaprene in 2020. And if the pivotal trial is successful and Ovaprene receives the FDA approval, it could be the only monthly hormone-free product available in the market. As such, we believe that Ovaprene is well positioned to capture a significant share of the contraceptive market since research suggests that a majority of women prefer a monthly option, specifically with lower hormone doses than the pill.

We're also committed to bringing to market the first FDA-approved treatment for female sexual arousal disorder, or FSAD, and are developing Sildenafil Cream, 3.6% for this indication. Sildenafil, a PDE5 inhibitor, is the active ingredient in Viagra. Sildenafil Cream is a topically administered formulation of sildenafil designed to increase local blood flow and provide a potential improvement in genital arousal response and overall sexual experience for women, similar to the way erectile dysfunction medications work by directing blood to the genitals when taken before sex. Sildenafil Cream has the potential to be the first product approved by the FDA for FSAD. And FSAD is the closest analog in women to erectile dysfunction in men, a lack of physiological response.

Independent market research suggests that 33% of women in the U.S. ages 21 to 60 experience symptoms of low or no sexual arousal, and 16% or approximately 10 million women are distressed and are seeking a solution to improve their condition. Thus, we believe the market potential for an approved product to treat FSAD is substantial. To put it in context, the prevalence of complete erectile dysfunction, or ED, is estimated to be about only 5% of men aged 40 increases to about 15% at age 70.

Presentations at the ACOG conference really highlighted the meaningful distress that FSAD causes in women and the unfortunate lack of treatment options. Our proprietary Sildenafil Cream formulation is specifically designed for use on-demand when she needs it in a similar manner to Viagra for erectile dysfunction in men but as a topical cream versus an orally administered product to minimize side effects and other negative effects of oral systemic exposure.

We're currently completing a noninterventional study intended to support the validity of specific patient-reported outcome measures to assess efficacy of Sildenafil Cream in the at-home portion of our Phase IIb clinical study program. The timing of when we'll initiate the Phase IIb at-home trial will be influenced by the guidance we receive from the FDA. Currently, we expect to commence the at-home portion of the Phase IIb study by the end of 2019. And based on that time line, we would expect to report top line data by the end of 2020.

Our fourth clinical stage candidate expected to enter Phase I clinical study this year is DARE-HRT1, a combination bio-identical estradiol and bio-identical progesterone intravaginal ring for hormone replacement therapy, or HRT, following menopause. Our novel intravaginal ring technology being developed to address the vasomotor symptoms in menopause, or DARE-HRT1, was originally developed by Dr. Robert Langer from MIT, and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. The design of HRT1 is intended to allow the continuous delivery of bio-identical estradiol and bio-identical progesterone in one vaginal ring over a 28-day period.

Consistent with the guidance from the North American Menopause Society, or NAMS, which supports hormone replacement therapy in peri- and postmenopausal women and recommend administering both estrogen to reduce symptoms and progesterone to prevent thickening of the uterine wall in a nonoral route over an oral route when possible, data presented at the recent ACOG conference highlighted the benefits of hormone replacement therapy and the safety of such therapy. Specifically compared with placebo, the risks associated with hormone replacement therapy in early menopausal women are statistically nonsignificant and are rare or less than 1 in 1,000 women per year of treatment whereas the benefits can be quite meaningful. Benefits highlighted include a reduction in all-cause mortality, fractures, new-onset diabetes mellitus as well as being the most effective therapy for significantly reducing menopausal symptoms, including vasomotor and vulvar vaginal atrophy.

More than 45 million women approaching menopause in the United States, the demand for new innovation to treat the vasomotor system -- symptoms is accelerating at a rapid pace.

Our intention is to commence the Phase I study of DARE-HRT1 in approximately 30 women in Australia this year. We believe conducting this study in Australia will be cost efficient as we can leverage our existing subsidiary and its opportunity for a cash rebate of over 40% of the research expenses incurred in Australia. We believe each candidate in our clinical stage portfolio as well as our preclinical candidates that we do not yet discuss today has the potential to deliver a first-line therapy or first-in-category product addressing a persistent unmet need in women's health.

Before I summarize the upcoming milestones again, I want to turn the call over to Lisa to review the financials.

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Lisa Walters-Hoffert, Daré Bioscience, Inc. - CFO [3]

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Thank you, Sabrina, and thank you all for participating on this update call. I would now like to summarize Daré's results for the first 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 candidates through value inflection and clinical milestones. As such, our financials consist primarily of general or corporate overhead expense, costs related to acquiring and maintaining our product candidates and research and development expenses.

During the quarter ended March 31, 2019, Daré's general and administrative expenses were $1.3 million, and our research and development expenses were $1.7 million. Our R&D expenses were primarily attributable to the costs related to the development activities for Ovaprene and Sildenafil Cream, 3.6% and, to a lesser extent, DARE-BV1 and DARE-HRT1. In addition, during the first quarter, we recognized license expenses of $112,500, representing deferred fees due pursuant to our agreements related to DARE-BV1. Our comprehensive loss for the quarter was approximately $3 million.

We ended the first quarter of 2019 with cash of approximately $3.5 million, [11.4 million] common shares outstanding, approximately $3.7 million warrants to purchase shares of common stock and no debt. In April, we completed an underwritten public offering of our common stock and sold an aggregate of about 5.26 million shares for gross proceeds of $5.8 million and net proceeds of approximately $5.2 million. The offering increased our common stock outstanding to approximately 16.7 million shares.

Given the landscape of other financing transactions we've seen completed for companies of our size, I would like to note that Daré was quite pleased to complete an offering comprised solely of common shares under our existing Form S-3 shelf registration statement, and we were equally pleased with the group of investors who participated in the offering. The offering had put us in a position to execute on the 2019 development plans and programs that Sabrina just described. We believe our cash at March 31, together with the proceeds from the public underwritten offering and approximately $982,000 available through the NIH grant for the Ovaprene clinical development expense, will be sufficient to fund our planned operations into the first quarter of next year or 2020. While we believe we are capital efficient as we execute on our planned operations and move these clinical candidates forward, we will need to access additional capital. We intend to explore multiple options for doing so, including, but not limited to, grant and foundation funding, collaboration agreements, strategic partnerships and the issuance of equity.

I would like to now turn the call back over to Sabrina.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [4]

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Great. Thank you, Lisa. 2019 is setting up to be a transformational year for Daré as we believe we are well positioned to capture value from our portfolio of women's health product candidates. And we are encouraged and excited with the level of interest and activity as it relates to our strategic partnering efforts. We look forward to keeping you updated on the clinical and regulatory milestones expected in 2019 from our Ovaprene and Sildenafil Cream programs, each of which has the potential to deliver a first-in-category product addressing a persistent unmet need in women's health as well as from our DARE-BV1 program in bacterial vaginosis, our IVR programs in hormone replacement and pregnancy maintenance and our vaginal tamoxifen for vaginal atrophy and NET hormone receptor-positive breast cancer population. Together, 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 ultimately for women.

As I mentioned at the beginning of the call, we expect to deliver against multiple clinical and regulatory milestones this year alone, specifically advancing our DARE-BV1 bacterial vaginosis program into a Phase III trial; announcing top line readout from our Ovaprene postcoital test trial in the second half of 2019; completing the content validity study for Sildenafil Cream and engaging with the FDA on the primary endpoint for the at-home portion of our Phase IIb study, which we expect can position us for a study start before the end of 2019; and preparing 3 additional programs with first-in-category potential for Phase I clinical development, DARE-HRT1 in 2019 and DARE-FRT1 and DARE-VVA1 in 2020.

We'll now turn it over to the operator, who will open the lines for the Q&A.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Yasmeen Rahimi with Roth Capital.

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Rachel Yang, [2]

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This is Rachel Yang on for Yasmeen. Congratulations on your progress.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [3]

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Thank you.

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Rachel Yang, [4]

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In the proof-of-concept study for DARE-BV1, the results show the clinical cure of 88% versus bacteriologic and therapeutic cure of 57%. What are the meaningful differences between clinical cure and bacteriologic cure? And is clinical cure rate a measure more used by physicians in the clinic?

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [5]

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Yes. That's a great question. This is Sabrina. Thank you for that. So in the treatment guidelines that actually the FDA puts out for clinical programs that are being evaluated for treatment, and to your point, when you think about the way that clinicians in the real world are managing bacterial vaginosis and how they and their patients are looking at improvements, all of that points to the end points that are used in clinical cure. And the clinical cure end points are really looking at the eradication of the -- basically elimination of the signs and symptoms of the disorder, which include both nuisance symptoms that she experiences, such as odor and discharge as well as specific changes in pH or type of cells that can be present in the presence of bacterial vaginosis.

So clinical cure is looking at really the improvement and elimination of those signs and symptoms. Bacteriologic and therapeutic cure rates are used as secondary end points, if you look at the FDA guidance for bacterial vaginosis studies. And those take into account in the context of a bacteriologic cure actual improvement in looking at the types of bacteria that are present based on an assessment of the bacteria morphology. And then a therapeutic cure looks at what proportion. And basically, you get a Nugent score based on that. And then therapeutic cure looks at what proportion of women experienced both a clinical cure, meaning improvement in their signs and symptoms of the condition, as well as that bacteriologic cure, that Nugent score. And so both the FDA and clinicians recognize that the clinical cure is what is most meaningful to women and from a health care perspective. So that's really your primary end point, it is looking at that improvement in the signs and symptoms. And that would be the primary end point in our clinical program as well.

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Rachel Yang, [6]

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Okay. So bacterial vaginosis can affect both healthy women and pregnant women, and recent research had shown that the changes in the microbiome are associated with the risk for preterm birth. So how has the potential wide-ranging use of DARE-BV1 affected your thinking over the inclusion and exclusion criteria for this upcoming pivotal study?

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [7]

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Yes. That's a great question. So typically, in a study like this, you would -- your primary goal is to basically look for women that meet the criteria for bacterial vaginosis. And I think some of the recent data like what you're saying that we talked about today that was presented at the ACOG conference by the March of Dimes really highlights, I think, the importance of treating bacterial vaginosis. And sometimes, with conditions like these, we get very focused on what the woman has experienced and what feels like nuisance effects as opposed to really taking a step back and understanding the important outcomes that are more far-reaching than just to nuisance signs and symptoms of the conditions. And so we're really thrilled to see the presentation about the link between bacterial vaginosis and preterm birth because we think it's just really building awareness as to the importance of really managing the condition effectively. And unfortunately, with the treatments that are out there today, it's very difficult for physicians to manage it effectively because the cure rates just aren't where everyone hopes it can be. And so we're really hopeful that a product like this has the potential to have really far-reaching benefit and obviously something that's delivered vaginally and on-demand with a onetime administration that's very favorable in terms of both the convenience but also because it really limits any kind of systemic exposure, which is obviously a benefit in any population that you may be studying.

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Rachel Yang, [8]

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Fine. Great. Absolutely. So can you also provide some color on the planned Phase III trial design for DARE-BV1? For example, like what will be the end points, lengths, doses? Are those going to be very similar to the proof-of-concept trial? And will there be any like major differences between the upcoming trial and proofs of concept? And finally, can you narrow down the time line to whether it's going to be closer to the third quarter or the fourth quarter?

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [9]

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Yes, definitely. So in terms of the end points and the trial design, the FDA put out a guidance document in 2016 that really lays out very nicely what the minimum requirements are. We will certainly pursue those. And so based on those requirements, you have a -- you establish that the woman meets the criteria for bacterial vaginosis, then you should administer either placebo or therapeutics, so in this case, DARE-BV1 or placebo. And then she comes back into what's called the test-of-cure visit at day 7 to 14. That is your primary end point visit, and that's where you look at those signs and symptoms of the condition and you determine statistically then what proportion of women in the active group versus placebo group met the test-of-cure criteria.

As a secondary end point, you'll also follow that woman out to day 21 to 30 where she'll come back in for another visit and do the same kind of assessment. And so as the secondary end point, you'll look at that continued clinical cure out to day 21 to 30. And then, bacteriologic cure and therapeutic cure are also secondary outcome measures.

So that's really the FDA guidance on what's required for the treatment indication and then -- and that therefore really reflects kind of what our minimum study design is.

As I mentioned, one of the reasons that we're looking to the timing that has us starting the trial later this year, and we have indicated that, actually, we're looking at starting in the fourth quarter of this year. So one of the reasons that we think that timing is really interesting and works very well for us is it's really given us an opportunity to talk to key opinion leaders as well as potential commercial partners who have already expressed an interest in the program and explore with them what enhancements beyond the very basic trial design that's required from an FDA perspective might be interesting for DARE-BV1 and might really highlight some of the unique attributes and features about the program. So as we get closer to initiating the start of the study, we'll provide a little more guidance about what that might look like at that time.

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Operator [10]

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Our next question comes from the line of Jason McCarthy with Maxim Group.

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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [11]

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Congrats on the progress this quarter.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [12]

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Thank you.

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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [13]

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So I'd like to see -- as we're approaching the data from the postcoital study, I'd like to see if you could give us an idea of what a pivotal trial for Ovaprene might look like, then what sort of end points you could look at and what kind of a trial size you'd need.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [14]

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Yes. That's a great question, and thank you for that. So as we think about a trial size for a product like Ovaprene, the first thing to keep in mind is that Ovaprene, because of its nature given that it's a nonhormonal product with -- it's a combination product with a barrier component as well as release of a locally acting spermiostatic agent, the FDA has determined that the device division of the FDA should lead the review of this product because in terms of the safety consideration, it's much more analogous to other types of nonhormonal products that the agency on the device side is more accustomed to reviewing as opposed to hormonal products that typically the drug side of the agency is used to reviewing. And that's really important because that likely will really influence what the pivotal study will look like.

So to be clear, in terms of a next step, if the PCT is successful, the next step will be to file our investigational device exemption with the FDA to commence that pivotal clinical trial. And that really is an important step and also us engaging with the agency around the design of the pivotal study. However, even in advance of that, we can give you a sense of what we think that pathway may look like really based on similar approvals and reviews that have been done through the device division of the FDA for contraceptive products. And specifically, we can look at the Caya diaphragm, which is the most recently approved product to be reviewed by that division of the FDA. It is a diaphragm, so it's pericoital method, meaning it's used on-demand in the moment as opposed to Ovaprene, which is once a month. But we believe that, nonetheless, given that it's the most recent product to go through the FDA, that it's a good surrogate for us to look at in terms of expected pivotal study design. And so based on those prior reviews by the device division, it's typically one pivotal study, so one contraceptive effectiveness study. They typically are 6 months in duration where they're looking at rates of pregnancy over the course of that 6 months. And often, they've had about 250 subjects make it out to that 6 months' time point. Based on dropout rates that are typical in contraceptive studies, you're often maybe enrolling closer to 450 or 500 women to get out to that about 250 completers at 6 months.

So that's our preliminary thinking about what the pivotal study should look like. And the plans would be -- based on the time line we talked about today, our expectation would be that, that would start in 2020 and run through 2021, putting us in a position to file in '22 for an approval in '23 based on our current expectations.

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Operator [15]

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(Operator Instructions) Our next question comes from the line of Brian Marckx with Zacks Investment Research.

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Brian W. Marckx, Zacks Investment Research, Inc. - Director of Research and Senior Medical Technology, Medical Device & Diagnostics Analyst [16]

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Sabrina and Lisa, regarding topical Sildenafil, I believe, in November, you announced the start of a thermographic feasibility study. I'm wondering if you can talk about the status of that and exactly what is it that you hope to learn from it.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [17]

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Yes. That's a great question. So thermography is -- basically it's using a camera to assess heat changes in temperature in body tissues, and it has been used as another way of looking at blood flow into the vaginal tissue or into any tissue, but it's been used specifically as a way in sexual dysfunction studies without a drug intervention, just sexual dysfunction studies, to look at a sexual response based on blood flow to the vaginal tissue.

It's really a different approach than the one that was used in the IIa that's already been completed for Sildenafil. You may remember that similar to what was done with oral Viagra in women, that demonstrated that oral Viagra, while it was troubling from a side effect profile and not a great candidate to pursue from a side effect profile for women, oral Viagra did increase blood flow to the genital tissue when evaluated with a vaginal probe. And Sildenafil, our cream, went through the same study looking at the vaginal probe, blood flow changes to show that it also increased blood flow to the vaginal tissue. So we've already done that study.

But thermography is a different approach to doing that, that can actually allow you a little more robustly to look at time course to that change in temperature and therefore, that change in blood flow. So we were interested in exploring whether you could actually pursue something like thermography with an investigational drug. So it's really a pilot study to see if just drug load itself interferes or not with the ability to detect temperature changes. So that study is actually still ongoing. We've been conducting it at one site, and it's an ongoing study. It's actually in healthy women, so these are not women with arousal disorder. It's really an opportunity, like I said, to see whether thermography might have some insightful findings for us as it relates to Sildenafil Cream. We will definitely keep people updated as that progresses and certainly hopeful that we might have some great learnings come out of that, but that's still ongoing at this point in time.

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Brian W. Marckx, Zacks Investment Research, Inc. - Director of Research and Senior Medical Technology, Medical Device & Diagnostics Analyst [18]

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Sabrina, is this potentially -- does this potentially relate to an end point in the upcoming studies?

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [19]

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Yes. Great question. No, it does not. So it's a great laboratory assessment. So if you think about it, the thermography studies, you have to do them in a special lab setup with a special kind of camera. It's a bit intrusive for the woman, quite frankly, to participate in a study like that. And the Phase IIb and Phase III programs are really meant to assess the performance of the product in a much more natural in-house setting. And so thermography is very analogous to some of the types of studies that they were able to do around erectile dysfunction where they actually looked at rigidity as opposed to men taking the product at home and using it in a home setting and reporting on their ability to have the kind of genital response that they want.

Our settings are going to be very similar in that regard, and think of it as thermography is an interesting potential tool that we can use outside of the clinical study in an at-home setting outside of that to maybe understand a little bit more about how the drug works as opposed to our Phase IIb and Phase III where the women will actually get to use the product at home with their partners in a very natural environment. And the content validity study that we're doing right now is really designed to help us hone in on the best questions to ask these women to make sure that we're capturing their most bothersome symptoms and improvement in their most bothersome symptoms of genital arousal response and that they understand the questions that we're asking. So the intent is, in the Phase IIb and Phase III studies, we will be using this questionnaire-based approach to understand the women's experience on the drug, very much analogous to how in erectile dysfunction studies you looked at, questions that the men answered about their experience using the product.

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Operator [20]

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I'm showing no further questions at this time. I would now like to turn the call back over to Sabrina for closing remarks.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [21]

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Great. Well, thank you so much to all of you for taking the time this afternoon and hearing our updates. We definitely look forward to keeping you updated on our progress, and thank you for your interest.

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Operator [22]

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Ladies and gentlemen, thank you for participating in today's conference. That concludes the call. You may now disconnect. Everyone, have a wonderful day.