Daré Bioscience, Inc. (DARE) CEO Sabrina Martucci Johnson on Q1 2019 Results - Earnings Call Transcript

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About: Daré Bioscience, Inc. (DARE)
by: SA Transcripts
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Earning Call Audio

Daré Bioscience, Inc. (NASDAQ:DARE) Q1 2019 Earnings Conference Call May 14, 2019 4:30 PM ET

Company Participants

Sabrina Martucci Johnson - CEO

Lisa Walters-Hoffert - CFO

Conference Call Participants

Rachael Yang - ROTH Capital Partners

Jason McCarthy - Maxim Group

Brian Marckx - Zacks Investments Research

Operator

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 Stellando [ph], and I'll 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. Miss Johnson, please proceed.

Sabrina Martucci Johnson

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 019 results, and our company highlights and upcoming milestones in 2019 and 2020.

Before we begin, I would 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 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, 2018, and our quarterly report on Form 10-Q for the quarter ended March 31, 2019, which was filed today.

I'd 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 wellbeing 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 am excited to discuss in more detail with you today the progress we have made during the first four 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 positioned 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 3 and Phase 2 candidates. During the first quarter, we continued enrollment in the Post-Coital Test clinical trial of Ovaprene, our monthly non-hormonal 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 FDA later this year, at which we intend to obtain its guidance on the endpoints for our Phase 2b and Phase 3 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 3 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 highlights the relevance of those persistent unmet needs and how our portfolio candidates are uniquely poised to address them. I'll start with our Phase 3 program in Bacterial Vaginosis, and then will provide an update on our Phase 2 programs, our non-hormonal 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 1 and Pre-phase 1 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 under-diagnosed clinical condition characterized by a shift in vaginal flora, because there is 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 pre-term 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 the pregnancy, her baby is at 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 women'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 is a significant opportunity for upside and market expansion, and importantly for improved outcomes for women. DARE-BV1 is our Phase 3 product candidate in development as a treatment for BV. With the addition of DARE-BV1 drug portfolio, we have 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, and in our planned Phase 3 program if we are 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.

Jarosz is preparing our Investigational New Drug application or IND or DARE-BV1, which we will need to file with the U.S. Food and Drug Administration or FDA, in order to commence a Phase 3 clinical trial of DARE-BV1 as planned by the end of 2019. This timing also gives us an opportunity to see trial-designed 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 3 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 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 comparable efficacy without the use of hormones. According to Global Market Insights 2017 report, the global market size in 2024 for the non-hormonal on-demand category of condoms and diaphragms alone is expected to reach 15 billion, which we believe reflects the growing preference for non-hormonal contraceptive methods.

The Ovaprene Post-Coital Test or PCT clinical trial is proceeding as expected, and top line data are expected in the second-half of 2019. In advance to 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 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 one to greater than 20 per high-powered field is associated with higher rates of pregnancy, less than five 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 a pivotal study, evaluating pregnancy prevention, demonstrating a product's contraceptive effectiveness. In terms of the contraceptive effectiveness assessed in pivotal studies that followed historic PCT studies for other non-hormonal product candidates, for those that exhibited success in their PCT study, uniformly exhibiting below five progressively motile sperm per high powered feel. Six 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 typically use effectiveness rates of 91%. Thus, if history is predictive, a non-hormonal product candidate that performs well and it's PCT study should go on to generate typical use effectiveness rates in the pivotal studies 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 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 bring into 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 PDE-5 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 general arousal response and overall sexual experience for women. Similar to the way erectile dysfunction medications work by directing blood to the genitals taken before sex. Sildenafil Cream has the potential to be the first product approved by the FDA for FSAD. And FSAD is the closest analogue 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 experienced 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 are currently completing a non-intravaginal study intended to support the validity of specific patient reported outcome measures to assess efficacy of Sildenafil Cream and the at-home portion of our Phase 2b clinical study program. The timing of when we initiate the Phase 2b at-home trial will be influenced by the guidance we received from the FDA. Currently, we expect to commence the at-home portion of the Phase 2b study by the end of 2019. And based on that timeline, we would expect to report topline data by the end of 2020.

Our fourth clinical stage candidate expected to enter Phase 1 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 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 and peri and postmenopausal women, and recommends administering both estrogen to reduce symptoms and progesterone to prevent thickening of the uterine wall in a non-oral 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 and early menopausal women are statistically non-significant and are rare, or less than one in a 1000 women per year treatment, whereas the benefits can be quite meaningful. Benefits highlighted included reduction in all-cause motility, fractures, new onset diabetes mellitus, as well as being the most effective therapy for significantly reducing menopausal symptoms including vasomotor and vulvar and vaginal atrophy.

More than 45 million women approaching menopause in the United States, the demand for new innovation to treat the vasomotor symptoms is accelerating at a rapid pace. Our intention is to commence the Phase 1 study of DARE-HRT1 in approximately 30 women in Australia this year. We believe conducting the 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.

Lisa Walters-Hoffert

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 in clinical milestones. As such, our financials consists 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 for $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 recognize license expenses of 112,500 representing deferred fees due pursuant to our agreements related to air 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 point million in 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 in 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 are equally pleased with a group of investors who participated in the offering. The offering has 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 in foundation funding, collaboration agreements, strategic partnerships, and the issuance of equity.

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

Sabrina Martucci Johnson

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 and Bacterial Vaginosis, our IVR programs and hormone replacement and pregnancy maintenance and our Vaginal Tamoxifen for vaginal atrophy and with hormone receptor positive breast cancer population. Together, these programs constitute arguably the most differentiated portfolio in women's health and when 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 Phase 3 trial, announcing top line readout from our Ovaprene Post-Coital 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 2b study, which we expect can position us for a steady start before the end of 2019 and preparing three additional programs with first in category potential for Phase 1 clinical development, DARE-HRT1 in 2019 and DARE-FRT1 and DARE-VVA1 in 2020.

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

Question-and-Answer Session

Operator

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

Rachael Yang

Okay. Hi. Thank you for taking my questions. This is Rachael Yang for Yasmeen. Congratulations on your progress.

Sabrina Martucci Johnson

Thank you.

Rachael Yang

In the proof-of-concept studies for DARE-BV1 and the results show the clinical care of 88% percent versus a bacteriologic and therapeutic care of 57%, what are the meaningful difference between the clinical care and bacteriologic care, and is clinical care really a measure more used by physicians in the clinic?

Sabrina Martucci Johnson

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 endpoints that are used in clinical care, and the clinical care endpoints are really looking at the eradication -- 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 care is looking at really the improvement and elimination of those signs and symptoms.

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

Rachael Yang

Okay, thank you so much.

Sabrina Martucci Johnson

Yes.

Rachael Yang

So, Bacterial Vaginosis can affect both healthy women and pregnant women, and recent research has shown that changes in the microbiome are associated with the risks 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?

Sabrina Martucci Johnson

Yes, that's a great question. So, typically in a study like this, you would -- your primary goal is basically look for women that meet criteria for Bacterial Vaginosis, and I think some of the recent data like what you are 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 women is experiencing 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 her nuisance signs and symptoms of the condition. And so, we are really thrilled to see the presentation about the link between Bacterial Vaginosis and preterm birth, because we think it is really building awareness as to the importance of the 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 are where everyone hopes they can be. And so, we are 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 one-time administration is 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.

Rachael Yang

Okay, great. Thank you. Thank you so much.

Sabrina Martucci Johnson

Yes, you bet. Yes.

Rachael Yang

Can you also provide some color on the planned Phase 3 trial design for DARE-BV1? For example, like what will be the endpoint length 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 the proof-of-concept? And finally, can you now down the timeline to whether it's going to be closer to the third quarter or the fourth quarter?

Sabrina Martucci Johnson

Yes, definitely. So, in terms of the endpoint and trial design, the FDA put out a guidance documented 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 with women meets the criteria for Bacterial Vaginosis, then you should administer either placebo or therapeutics, in this case DARE-BV1 or placebo, and then she comes back into what's called the test of care visit, day seven to 14. That is your primary endpoint visit, and that's where you look at the signs and symptoms of the condition and you determine statistically then what proportion of women in the active group versus placebo group met that test of care criteria. As a secondary endpoint, you will also follow that women out to day 21 to 30 will sure come back in for another visit, and do the same kind of assessment. And so, the secondary endpoint you'll look at that continued clinical care out to day 21 to 30, and then bacteriologic care and therapeutic care are also secondary outcome measures. So that's really the FDA guidance on what's required for the treatment indication. And that therefore really use likes what your minimum study design in.

As I mentioned, one of the reasons that we are looking to the timing that has us starting the trial later this year, and we have indicated that actually we are 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 that 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 will provide a little more guidance about what that might look like at that time.

Rachael Yang

Okay, great. Thank you so much, and congratulations once again on your progress.

Sabrina Martucci Johnson

Thank you. Thank you very much.

Operator

Thank you. Our next question comes from the line of Jason McCarthy with Maxim Group. Your line is open.

Jason McCarthy

Hey, thanks for taking the question, and congrats on the progress this quarter.

Sabrina Martucci Johnson

Thank you.

Jason McCarthy

So, I would like to see as we are approaching the data from the post-coital study, like to see if you could give us an idea what a pivotal trial for Ovaprene might look like? Then, what sort of endpoints you could look at, and what kind of a trial size you need?

Sabrina Martucci Johnson

Yes, that's a great question and thank you for that. So, as we think about a trial size for product like Ovaprene, the first thing to keep in mind is that Ovaprene because of its nature, given that it's a non-hormonal product with -- it's a combination product with the barrier component as well as release a locally acting spermiostatic agent. The FDA has determined that the device division of the FDA should leave the review of this product, because in terms of the safety consideration it's much more analogous to other types of non-hormonal products at the agency on the device side is accustomed to reviewing as opposed to hormonal products that typically the drug side of the agency used to reviewing. And that's really important because that likely will really influence what the pivotal study would 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 s diaphragm, so it's a peri-coital 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 stage 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 six months in duration, where they're looking at rates of pregnancy over the course of that six months, and often they've had about 250 subjects make it out to that six months time point based on dropout rates that are typical in contraceptive studies, you're often maybe enrolling closer to 450 or 500 women that to get out to that about 250 completers at six months. So that's our preliminary thinking about what the pivotal study should look like, and the plans would be based on the timeline we talked about today, our expectation would be 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.

Jason McCarthy

All right, thank you very much.

Sabrina Martucci Johnson

Yes, thank you, great question.

Operator

[Operator Instructions] Our next question comes from the line of Brian Marckx with Zacks Investments Research. Your line is open.

Brian Marckx

Hi, Sabrina and Lisa. Regarding topical Sildenafil, I believe in November you announced the start of a thermographic feasibility study…

Sabrina Martucci Johnson

Yes.

Brian Marckx

-- I'm wondering if you can talk about the status of that, and exactly what is it that you hope to learn from it?

Sabrina Martucci Johnson

Yes, that's a great question. So, thermography is a basically using a camera to assess heat, changes in temperature in body tissues. And it has been used as another way of looking at what 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 to 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 we've used in the 2A 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 -- our great candidates pursue from a side effect profile for women, oral Viagra did increase blood flow to the general 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's also increased blood flow to the vaginal tissue.

So, we have 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 till 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 it just drug loaded self, you know, fears are not with the ability to detect temperature changes. So, that study is actually ongoing. We've been conducting 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, you know, as that progresses, and that certainly hopeful that we might have some great learnings come out of that, but that's still ongoing at this point in time.

Brian Marckx

Sabrina, is this potentially -- does this potentially related to an endpoint in the upcoming study?

Sabrina Martucci Johnson

Yes, great question. No, it does not. So, it's a great laboratory assessment. So if you think about it thermography studies you have to do them in a special lab set up with the special kind of camera, it's intrusive for the women quite frankly to participate in a study like that, and the Phase 2b and Phase 3 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 deal around erectile dysfunction, where they actually looked at rigidity as opposed to man taking the product at home and using it in their home setting and reporting on their ability to have the kind of general response that they want. Our studies are going to be very similar in that regard, and I think of it as thermography is an interesting potential tool that we can use outside of the clinical study, international setting outside of that to maybe understand a little bit more about how the drug works as opposed to our Phase 2b and Phase 3, where the women will actually get to use the product in home with her 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 symptom, the genital arousal response, and that they understand the questions that we're asking. So, the entireness in the Phase 2b and Phase 3 studies, we will be using this questionnaire-based approach to understand the women's experience on the drug, very much analogous to have an erectile dysfunction studies you looked at that questions and many answered about their experience using the product.

Brian Marckx

Okay. Thanks, Sabrina.

Sabrina Martucci Johnson

Yes, no, great question.

Operator

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

Sabrina Martucci Johnson

Great. Well, thank you so much 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.

Operator

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