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

Q2 2019 Dare Bioscience Inc Earnings Call

Cambridge Sep 13, 2019 (Thomson StreetEvents) -- Edited Transcript of Dare Bioscience Inc earnings conference call or presentation Wednesday, August 14, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Christine K. Mauck

CONRAD - Medical Consultant

* David Friend

Daré Bioscience, Inc. - Chief Scientific Officer

* John Fair

Daré Bioscience, Inc. - Chief Business Officer

* 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

* James Francis Molloy

Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst

* Jason Howard Kolbert

Dawson James Securities, Inc., Research Division - Director of Research

* Joanne Lee

Maxim Group LLC, Research Division - Equity Research Associate

* Yasmeen Rahimi

Roth Capital Partners, LLC, Research Division - MD, Senior Research Analyst & Co-Head of Biotechnology Research

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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 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 Joelle, and I'll 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.

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

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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 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 June 30, 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, 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 (inaudible) 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 (inaudible) product candidates at various [visits] and development continuum and across multiple therapeutic areas.

For today's call, we'll focus on our 3 later-stage clinical product candidates: DARE-BV1, Ovaprene and Sildenafil Cream, 3.6%.

Before we address each of these product opportunities, I just 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 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 4 years. And we're 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 is also an active adviser to investment bank. Among his accomplishment, Bill served as the Chairman and CEO of Idec Pharmaceuticals with instrumental -- and was instrumental in leading the multibillion-dollar merger of equals between Idec and Biogen. He was Chairman of Illumina from 2005 to 2016, and was also (inaudible) the co-founder of Receptos, which was acquired by Celgene in 2015 for $7.2 billion. Bill holds a PhD 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 in 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 5-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 we've received from the scientific community specific to DARE-BV1.

For those who 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?

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David Friend, Daré Bioscience, Inc. - Chief Scientific Officer [3]

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Thank you, Sabrina. With respect to our DARE-BV1 program, we're excited to be moving this program into what we believe will be a single Phase III registration 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 feeding bacterial vaginosis, the reactions from the scientific and medical community for 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 top line 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 evaluable patients seen at the day 7 to 14 visit, also known as the test-of-cure visit. Most physicians there were very familiar with BV and many expressed 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 front-line option for the treatment of BV.

As it relates to our broader scientific communication strategy, we continue to publish and present findings of our portfolio of 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 top line 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.

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

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Thank you, Dave, and congratulations to you and your team for all of your hard work and well-earned success.

We would like to turn our attention to our exciting prepivotal product candidate, Ovaprene. Ovaprene is a novel vaginal ring that has the potential to disrupt the contraceptive space by being (inaudible) initiated contraceptive approved by the FDA. Ovaprene is designed to be used on a cycle-by-cycle basis, just like a NuvaRing, giving greater flexibility and control with a 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 top line data in the fourth quarter.

With us today is Dr. Christine Mauck, our Medical Director, supervising the Ovaprene PCT study. I've asked Christine to provide us with an update on the PCT study.

And with that, I'll turn it over to you, Christine.

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Christine K. Mauck, CONRAD - Medical Consultant [5]

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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 have been involved in the program design and the clinical trials of a number of FDA-approved birth control options. What got me particularly excited about Ovaprene was the idea of something that is nondaily, hormone-free and hormone controlled. It's really challenging to find all 3 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 pills, patches and vaginal rings, which provide 88% to 91% effectiveness in normal use, also known as typical use.

Today, hormone-free contraceptive products fall into 2 categories. The first category must be used at or shortly before intercourse, include diaphragms, condoms, spermicides and multipurpose gels and shows lower typically used contraceptive effectiveness as compared to hormonal methods.

The second nonhormonal category includes long-acting copper IUDs, which while effective must be administered by a physician and, hence, are not woman 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 and announce top line 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're fortunate to have some of the top reproductive health sites in the country participating in the 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 5 progressively motile sperm per high-power field in the cervical canal in those women and that Ovaprene can be safely worn over multiple weeks, we intend 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.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [6]

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Thanks, Christine. And I'd like to acknowledge additional work of Christine and the full clinical operations team with respect to our PCT trial. Their collective 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 -- thank you, I want to speak about our third later-stage product candidate 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 noninterventional content validity study that we commenced late last year.

We'll disclose the study (inaudible) 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 of (inaudible) because they will position us to hold a Type C meeting with the FDA to review successive filings, which is aligned with the FDA (inaudible). We will continue to provide (inaudible) 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 category portfolio (inaudible) as well as those that have been discussed has the potential of becoming either a first-line therapy or a first-in-category solution or both and to deliver on our mission to (inaudible) persistent unmet need in women's health.

I'll now turn the call over to Lisa, our CFO, to review the financials.

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Lisa Walters-Hoffert, Daré Bioscience, Inc. - CFO [7]

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Thank you, Sabrina, and thank you all for participating today on the 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, the works that we are doing on DARE-BV1 and DARE-HRT1. Our comprehensive loss for the quarter was $4.7 million of which $790,000 represented a noncash deemed dividend related to the reduction of the exercised 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 execute on our planned operations and move our clinical candidates forward, we will need to raise additional capital.

We continue -- intend to continue to explore multiple options, including, but not limited to, grant and foundation funding, collaboration agreement, strategic partnerships and the issuance of equity.

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

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [8]

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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 a 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 for the treatment of bacterial vaginosis; from our non-daily, hormone-free contraceptive candidate, Ovaprene; and from our first-in-category treatment opportunity for FSAD (inaudible) program.

Together with our Phase I clinical stage and preclinical 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'll open the lines for 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 Yasmeen Rahimi with Roth Capital Partners.

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Yasmeen Rahimi, Roth Capital Partners, LLC, Research Division - MD, Senior Research Analyst & Co-Head of Biotechnology Research [2]

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Congratulations on QIDP. So 2 questions for you. Question one is, can you remind us what are the components of the BV pivotal trial that are set in stone? And which elements remain for debate? And then the second question is on the postcoital test. Can you walk us sort of through what your expectations are? And then followed by walk us through how filing with the device division differs from the traditional FDA pathway that in relation to the contraception drug development, that will be very helpful.

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

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Yasmeen, this is (inaudible) so for the BV bacterial vaginosis program (inaudible) as it relates to bacterial vaginosis, and our program will, of course, very much align 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 our draft guidance kind of [approval] from a trial design perspective following that guidance document in terms of the bare minimum of what's required for the program. Some of things that worth (inaudible) 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 (inaudible) historically is, are there ways to capture some additional data in the Phase IIb trial. None of which required for approval that might help guide physicians on what to expect from a treatment that (inaudible) 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, but hopefully, from a bare minimum that gives you a perspective either relatively short studies and that you're really only following women for about a month because this is an acute treatment.

And as it pertains to Ovaprene and the postcoital test study with Ovaprene, as Christine mentioned, the primary endpoint is looking for less than 5 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 those studies, those products with those -- studies with those products that have shown less than 5 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 Chris was talking about.

And in terms of your question from a regulatory perspective, 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, with the device division of the FDA, there is a few things to keep in mind. One is the postcoital test (inaudible) becomes an important [method] 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 the next step would be to file and submit the IDE. And then in terms of what the device division typically looks for is the

(technical difficulty)

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John Fair, Daré Bioscience, Inc. - Chief Business Officer [4]

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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, Yasmeen. So the other 2 components of going the CDRH pathway versus the CDER pathway is the size of the trial will likely be smaller to our belief, 250 women and a single-phase, single-arm study. And then the length of the trial is likely going to be shorter as well. So likely 7 cycles or 6 months versus your traditional 13 cycles or 1 year study for CDER.

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Operator [5]

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And our next question comes from Jason Kolbert with Dawson James.

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Jason Howard Kolbert, Dawson James Securities, Inc., Research Division - Director of Research [6]

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I have several questions across several areas. I want to pick up on what Yasmeen 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 and BD, in terms of extending the runway? Why don't we deal with the finances first?

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

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Yes. And this is Sabrina. And John definitely jump in if I break up.

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John Fair, Daré Bioscience, Inc. - Chief Business Officer [8]

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

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

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Yes. Well, thank you for letting me know. So I'll answer 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

(technical difficulty)

for equity financing...

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John Fair, Daré Bioscience, Inc. - Chief Business Officer [10]

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

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [11]

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

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John Fair, Daré Bioscience, Inc. - Chief Business Officer [12]

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Yes, yes, for sure. Thanks, Jason. Yes. So I think we're -- broadly speaking, we feel very comfortable where we are 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 the full data readout, which we think is a very big catalyst for the company and a value driver. In terms of getting Daré-BV funded and underway in study initiation and study start, we feel very comfortable with that. And Sildenafil, as 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 catalysts in the very near future, we have a lot of optionality as it relates to attracting more capital to the company. And maybe I'll ask Lisa to make some comments around that.

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Lisa Walters-Hoffert, Daré Bioscience, Inc. - CFO [13]

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Yes. No, and I just really kind of reiterate what's already been said. What's 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 John and Sabrina have said, as these candidates advance and we have additional data and also color and clarity on clinical development, it makes them more attractive to potential partners. And then last, but not least, I am a big fan of grant funding. It's a wonderful way to keep the portfolio moving ahead in a nondilutive way to shareholders. So rest assured, as the CFO, we are looking at all 3 options constantly and trying to figure out the best path forward for shareholders.

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Jason Howard Kolbert, Dawson James Securities, Inc., Research Division - Director of Research [14]

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And can I ask a kind of sensitive question because you really are dedicated to women's health, and Ovaprene -- not just Ovaprene, but as it has the potential to kind of change the paradigm, how timely is this? And does that matter? I mean in the era of the Me Too movement, is that something that could potentially impact partnering?

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John Fair, Daré Bioscience, Inc. - Chief Business Officer [15]

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Yes. So I'll start on that. I think you 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 is a tremendous amount of options and variety out there, but there's still a lot of unmet needs, 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 nondaily, that's under her control. These are all things that to your point really play into women's empowerment and 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 is 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. There -- we've looked at the data in incidence and prevalence and FSAD, which is an 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. Okay?

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Jason Howard Kolbert, Dawson James Securities, Inc., Research Division - Director of Research [16]

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And one last question regarding the QIDP designation and its linkage to Fast Track status -- 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 potential partner?

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John Fair, Daré Bioscience, Inc. - Chief Business Officer [17]

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Yes. Agreed, and we were very, very -- go ahead, Sabrina. It sounds like you're back.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [18]

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Right. I'm hopefully back. I'm just going to say, yes, so basically as we pursue through the regulatory process, those were 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 5 years of exclusivity to potential partners.

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Jason Howard Kolbert, Dawson James Securities, Inc., Research Division - Director of Research [19]

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

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [20]

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Correct. That is our understanding.

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Christine K. Mauck, CONRAD - Medical Consultant [21]

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

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John Fair, Daré Bioscience, Inc. - Chief Business Officer [22]

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Thanks, Chris.

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Christine K. Mauck, CONRAD - Medical Consultant [23]

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Okay.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [24]

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Thank you.

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Operator [25]

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And our next question comes from Jason McCarthy with Maxim Group.

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Joanne Lee, Maxim Group LLC, Research Division - Equity Research Associate [26]

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This is Joanne Lee on the line for Jason. Congratulations on a great progress this quarter. 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 size, eligibility criterion, et cetera? And following that, could you shed some color on the patient-reported outcome measurements that are being utilized to assess efficacy in FSAD?

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [27]

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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 the FDA because as you can imagine, (inaudible) outcome, the end point is really

(technical difficulty)

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John Fair, Daré Bioscience, Inc. - Chief Business Officer [28]

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Yes. So I'll pick up on that, Joanne. So we have not publicly disclosed the design of the Phase IIb because, again, this is a -- since this is a new area and it's essentially a new domain for the agency, we want to make sure that we are -- 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 and 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 the tool or process by which we need to review with the FDA and get greater alignment and clarity before we move that one forward, so we have -- again, we have not disclosed exactly what the PRO components are at this point.

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Joanne Lee, Maxim Group LLC, Research Division - Equity Research Associate [29]

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Okay. Great. And what will be the time line surrounding the Phase II trial? Could we expect top line 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?

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John Fair, Daré Bioscience, Inc. - Chief Business Officer [30]

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Yes, we're -- there you go, Sabrina.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [31]

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(inaudible) so I'm back. So in terms of the timing, we'll definitely update, as we've mentioned today, we're in the final stages of that study. So as soon as we can, we'll update on the completion of that. And the FDA, when we -- that was in the last Type C meeting, already agreed to this next Type C meeting. So really it'll 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 be definitely be providing it. But based on our current expectations, we believe that we are still on a path that could allow us to start this study this year. But as soon as we have more information, we'll definitely provide it.

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Joanne Lee, Maxim Group LLC, Research Division - Equity Research Associate [32]

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Great. And my last question is related to Ovaprene. There are some clear honest 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?

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [33]

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Yes. Do you want to -- John, do you want to start? I can start, but if I cut off again, just jump in.

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John Fair, Daré Bioscience, Inc. - Chief Business Officer [34]

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Yes, you should start.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [35]

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Perfect. Okay. So in terms of the design of the study, (inaudible) one of the main differences is really duration of study, our expectation is and size. So fewer subjects and shorter duration is the

(inaudible) the size in terms of the primary endpoint, you're still looking at pregnancy rate, that is what you look at in the contraceptive studies. And with a product like Ovaprene, what's nice is that it's once a month product. So from a compliance perspective of what she has to do in the study. It's just once a month. She inserts it post menses, she leaves it in place until her next menstrual cycle and removes it. And so that definitely helps 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 were participating in a different study.

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Joanne Lee, Maxim Group LLC, Research Division - Equity Research Associate [36]

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Congrats on the progress.

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [37]

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Thank you.

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Operator [38]

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And our next question comes from Jim Molloy with Alliance Global Partners.

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James Francis Molloy, Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst [39]

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My apologies if this has been asked already. I'm bouncing between a couple of calls. But on the FSAD, I think Joanne may have stolen my thunder on 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 question, and that sort of thing. Is that something we have to wait for the meeting with the FDA?

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [40]

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Yes. You have to wait for the meeting with the FDA. And I will say that even that we may be 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 what we can say is that, as John mentioned, it's very much focused on the general sensations at arousal. So what is her most bothersome symptoms when it comes to those general sensations at arousal, what is she most concerned about, what is she bearing 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.

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James Francis Molloy, Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst [41]

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Got it. And then on the -- I know you guys are -- obviously, a number of programs are ongoing. You'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 trial? What will the next couple that you guys will be looking to potentially advance next into sort of Phase I?

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [42]

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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 while they are preclinical, they are leveraging the 505(b)(2) regulatory pathway and as a result can advance fairly quickly into that clinical phase. And so really next step 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 bioidentical estradiol and progesterone together in 1 ring. So it's really the only product right now in development that's delivering those hormones for hormone replacement in the way that Menopause Society and the medical institutions recommend. So we're 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, our vaginal tamoxifen as well as our fertility vaginal ring, FRT1, with bioidentical progesterone. Both of those are just teed up in terms of manufacturing activities so that we can work for advancing those into the Phase I clinic next year. So those are really our goals with those programs in terms of the next phase that will be moving into the clinic.

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Operator [43]

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And our final question comes from Brian Marckx with Zacks Investment.

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Brian W. Marckx, Zacks Investment Research, Inc. - Director of Research and Senior Medical Technology, Medical Device & Diagnostics Analyst [44]

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

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [45]

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Yes. That's a great question. So the way that study works, obviously, we've got through recruitment, like everyone (inaudible) one of the very important factors in participating in this study is that the couple have to demonstrate that enough about the presence of any product can make 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 enough 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 the assessments they go through. It's actually 5 cycles of assessments, 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 they were going to have data in the fourth quarter.

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Brian W. Marckx, Zacks Investment Research, Inc. - Director of Research and Senior Medical Technology, Medical Device & Diagnostics Analyst [46]

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Okay. And Sabrina, I think you'd mentioned before that you expect 25 couples, I believe, in the study. What is the -- just given that this is a PCT study is somewhat nonconventional as it goes for just typical drug or device study, I mean, just the design, does that increase -- potentially increase the risk that the dropout rate may be 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 be -- to have this sufficient data at the end?

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [47]

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Sure, sure. Great question. So typical PCT studies are in the range of 15 to 30. So we target -- but it doesn't have to be 25 but 25 is what we targeted. Generally, in contraceptive studies and definitely in PCT studies have higher dropout rates than you may see in other therapeutic areas as sometimes as high as 50% dropout rate. So that's definitely conservatively what we wanted to plan for so that we could comfortably ensure that while our goal is 25, we're really looking for somewhere between 15 to 30 women completing both assessments in the study. She actually goes through 2 different Ovaprene PCT assessments. It's actually much more robust than been done with any other products. So we are targeting 25 completing both, but really the goal is kind of in that 15 to 30 range.

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Operator [48]

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

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Sabrina Martucci Johnson, Daré Bioscience, Inc. - President, CEO, Secretary & Director [49]

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Well, thank you, and thank you, everyone, for taking the time this afternoon and apologies if my line was a little bit disruptive for a 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.

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Operator [50]

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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.