Daré Bioscience, Inc.
Q3 2019 Earnings Call Transcript

Published: 15 Nov 2019

[Operator:]

Welcome to the conference call hosted by Daré Bioscience to review financial results for the quarter ending September 30, 2019 and to provide a general business update. This call is being recorded. My name is Sarah and I will be your operator today. With us are Sabrina Martucci Johnson, Daré's President and Chief Executive Officer, John Fair, Chief Business Development Officer and Lisa Walters-Hoffert, Daré's Chief Financial Officer.Ms. Johnson, please proceed.

[Sabrina Martucci Johnson:]

Thank you and welcome to our financial results and business update call for Daré Bioscience. It's a pleasure to have the opportunity to talk about our third quarter results and our company highlights and upcoming milestones for the remainder of 2019 and 2020.Before I begin, I would like to remind you that today's discussion will include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical 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 September 30, 2019, which was filed on November 12.I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, November 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 squarely focused on improving the life and well-being of women, primarily in the areas of contraception, vaginal health, sexual health and fertility. We continue to deliver on our vision of becoming the premier accelerator of innovation in women's health by advancing our product candidates to meaningful value inflection points and delivering on key program milestones.On today's call, we will review the two important and exciting updates that we announced earlier this week, the results of our pre-pivotal clinical study of Ovaprene monthly hormone-free vaginal contraceptive candidate and our definitive merger agreement with Microchips Biotech to add an innovative drug delivery platform to our portfolio with the potential to bring truly game changing technology to multiple therapeutic areas including contraception. After we review these very recent development updates, we will spend some time discussing the progress of our late-stage assets, DARÉ-BV1 and Sildenafil Cream, 3.6% and the upcoming milestones you can expect in the balance of 2019 and 2020.Let's start with Ovaprene. We are extremely pleased to be able to share with you the top line findings of our Ovaprene postcoital test clinical trial, a pre-pivotal clinical study. There results are in line with our expectations for this product and sets the stage for filing the investigational device exemption or IDE application, which is an important step toward advancing the product into what we believe will be a single pivotal clinical trial. For investors that are new to the Daré story, the prescription contraceptive market is valued at more than $5 billion in the U.S. alone. What means for a company like ours that are actively innovating in this area is that a few market share points can deliver significant value.An independent analysis estimates that every 1% of the total prescription contraceptive market equals roughly $160 million in branded prescription value. So a product that is able to garner high single digit market share like Merck's monthly hormone contraceptive NuvaRing, for example, can deliver between $500 million and $1 billion of top line sales. Currently there aren't any effective, highly effective hormone free options available to women that are fully women controlled and designed to suit her lifestyle and life stage via convenient monthly dosing.This clear and persistent unmet need encouraged us to identify a product that could be a viable and effective new option and eventually led us to the Ovaprene hormone free monthly vaginal contraceptive. Ovaprene has an opportunity to be a truly disruptive technology. It has once-per-month convenience associated with Merck's monthly contraceptive NuvaRing which had global sales of over $900 million in 2018 and the potential to offer effectiveness in the same range of hormonal products but without the use of hormones.We believe that is important, because there are a significant number of women who are seeking alternatives to hormonal contraceptives. In some cases, they are contraindicated, meaning they are not able to take hormones because of an existing medical condition or they are unwilling to use hormones as their primary method of birth control. We believe these women can be very early adopters of the product, but we also anticipate that current users of hormonal birth control will be interested in Ovaprene since the classic side effects associated with hormones including weight gain, nausea and mood changes could be avoided, which is why we are so excited to review our top line Ovaprene PCT findings with you today on the call.To begin, a postcoital test or a PCT is a regular clinical trial designed to challenge a device like Ovaprene via a predicted surrogate marker for contraceptive effectiveness. It involves taking numerous samples from each subject's cervical mucus post-intercourse during ovulation which is the most vulnerable time for women in terms of conception. These samples are then analyzed by trained clinicians utilizing a high-powered microscope to determine the number of progressively motile sperm in the samples. The results are considered a surrogate for the contraceptive effectiveness thus fewer the sperm observed, the more effective the device is likely to be in terms of preventing pregnancy.As we stated in our recent press release, we are very excited to report that the PCT study met its primary endpoint. A 100% of women and across 100% of cycles in which Ovaprene was worn, Ovaprene prevented essentially all progressively motile sperm from reaching the cervix. To put this data into perspective, women enrolled in the study had a mean of 27.21 progressively motile sperm per high powered field in their baseline cycle. That's without the Ovaprene device. That means all of the women enrolled in the study had partners with viable sperm and sperm counts.Importantly, all the women enrolled in the study had normal ovulation cycles and samples were taken during peak ovulation, the most challenging time frame for a contraceptive device like Ovaprene. The top line results for Ovaprene revealed that women utilizing the Ovaprene device had a mean of 0.48 progressively motile sperm per high power field in their Ovaprene PCT cycles, with a median of zero progressively motile sperm.To put that in perspective, that means in this study, Ovaprene was nearly 100% effective at preventing progressively motile sperm from reaching the cervical canal cross all the women and all the cycles. Other contraceptive products that demonstrated no motile sperm in the cervical mucus in their PCT clinical studies of similar size went on to demonstrate typical use contraceptive effectiveness of 86% to 91% in pivotal studies evaluating pregnancy rates over a six month period, similar range to typical use effectiveness rates of hormonal methods like pills, patches and vaginal ring, such as the NuvaRing monthly vaginal ring that we discussed earlier.As we have previously communicated, the data from this study will be used to support an IDE filing with the Center for Devices and Radiological Health, a division of the U.S. Food and Drug Administration, that has been designated to review Ovaprene under the FDA's premarket approval process. Pending FDA review and clearance of the IDE, we plan to initiate a pivotal contraceptive effectiveness and safety study of Ovaprene in the second half of 2020. If successful, we expect that study to support marketing approval of Ovaprene in the United States, Europe and other countries worldwide.In addition to the outstanding news on Ovaprene this week, we also have another important and exciting update to share with you that will give us access to what we believe is another potentially game-changing drug-delivery technology platform. Right now, you may have seen the news detailing our agreement to acquire Microchips Biotech, an innovative biotechnology company that is working at the cutting edge of drug-delivery.The technology platform was developed by renowned MIT researchers, Dr. Robert Langer and Dr. Michael Cima and has received investment funding by leading healthcare and venture investors, including Polaris Venture Partners, MS Pace, Intersouth Partners and Teva Pharmaceuticals. The contraceptive development program in particular has been supported by up to $20.5 million in grant funding from the Bill and Melinda Gates Foundation to further refine and develop this long-acting user-controlled implantable contraceptive system designed to enable women to customize the regulation of their fertility by enabling and disabling the device, controlling the release of the active contraceptive agent remotely.I will ask our Chief Business Development Officer, John Fair, to provide a little more insight into the technology.

[John Fair:]

Thank you Sabrina. We believe the acquisition of this highly complementary product candidate will translate into immediate value creation for Daré. This program is fully funded through its current stage of preclinical development and is eligible to receive up to $2.5 million in additional funding from the Gates Foundation in 2020, which will cover the cost of ongoing preclinical development activities and when combined with amounts already received to-date, will bring the total grant funding to approximately $20.5 million. It's an important new technology for us in that there is truly nothing else like it on the development landscape and it doesn't compete with or in its current stage draw resources from any of the technologies we are currently developing for women's health.The technology is a microchip-based implant that is a self-contained hermetically-sealed drug device. The device in its final iteration is intended to be easy to implant and remove, store numerous therapeutic doses that can be delivered over months or years and deliver each dose on a precisely-timed, predetermined schedule to achieve the desired therapeutic effect. The device is designed to be controlled by the patient via a wireless remote and importantly for the contraceptive indication to be completely disabled by the patient for rapid return to fertility.We think of it as a user-controlled long-acting form of contraception akin to a contraceptive implant that has the innovation of being able to be turned off or on based on the needs and the desires of the user. The functionality should allow for convenient return to fertility, giving her the ability to resume her protection upon her discretion at some future date. It's an exciting new technology that we believe holds a tremendous amount of promise and is a great addition to our portfolio.With that, I will turn back over to Sabrina.

[Sabrina Martucci Johnson:]

Thank you John. In the time that we have left, I wanted to highlight progress on our bacterial vaginosis or BV program DARÉ-BV1 including our Phase 3 preparations and timeline and Sildenafil Cream, 3.6%, our novel cream formulation of sildenafil with the potential to be the first FDA approved treatment option for female sexual arousal disorder. DARÉ-BV1 is a novel thermosetting bioadhesive hydrogel formulated with the 2% clindamycin, an antibiotic used to treat certain bacterial infections, including BV. DARÉ-BV1 is designed to be administered in a convenient single vaginal delivery application.The bioadhesive properties of DARÉ-BV1 are believed to prolong the duration of exposure to clindamycin relative to currently marketed creams potentially improving the rate of clinical effectiveness compared to existing FDA approved therapies. Current FDA approved therapies to BV have clinical cure rates ranging from 37% to 68%. In an investigative initiated proof of concept study that enrolled 30 women, DARÉ-BV1 demonstrated an 86% clinical cure rate in the 26 evaluable subjects at the test-of-cure visit after one administration.We plan to utilize the FDA's 505(b)(2) pathway to obtain marketing approval of DARÉ-BV1 for BV in the U.S. To that end, we are currently working on regulatory and startup activities that are necessary to commence a Phase 3 multi-center randomized double-blind placebo-controlled study in the U.S. and expect to initiate this study in early 2020. We plan to enroll approximately 219 women, the primary efficacy endpoint of the study will be clinical cure at evaluation visit to occur 21 to 30 days after a moment in the study with clinical cure defined as resolution of specified clinical signs and symptoms. If the Phase 3 and the non-clinical studies that we plan to conduct in parallel with the Phase 3 are successful, we expect to be in a position to file an NDA with the FDA in late 2020 or early 2021.To provide additional data in support of DARÉ-BV1 value proposition, we also plan to conduct an extension study, during which subjects will receive no additional treatment but will be evaluated 60 and 90 days post dosing with DARÉ-BV1 to evaluate the duration of response or a sustained clinical cure as compared to treatment with metronidazole vaginal gel which is the treatment that subjects in the Phase 3 study will receive if BV symptoms are not otherwise resolved. We anticipate that the extension study will provide important data to support DARÉ-BV1 as a differentiated treatment option with both commissioned and payors.Finally, I am excited to provide an update on our Sildenafil Cream, 3.6% program which incorporates sildenafil, the same active agreement ingredient in the male erectile dysfunction drug, Viagra. If approved, Sildenafil Cream could be the first FDA approved FSAD treatment option for women. Female sexual arousal disorder or FSAD, as I refer to it, is a condition characterized primarily by a persistent or recurrent inability to attain or maintain sufficient general arousal during sexual activity frequently resulting in distress or interpersonal difficulty.As with erectile dysfunction in men, FSAD in women is associated with insufficient blood flow to the genitalia. Sildenafil Cream is designed to increase general blood flow and provide improvements in the female genital arousal response while avoiding systemic side effects observed with oral formulations of sildenafil. We plan to leverage the existing data and established safety profile of sildenafil and the Viagra brand to utilize the FDA's 505(b)(2) pathway to obtain marketing approval of Sildenafil Cream in the U.S.During the third quarter of 2018, we had a Type C meeting with the FDA regarding the design of our Phase 2b clinical trial for sildenafil and the overall development program for this product candidate. Based on the FDA guidance we received from that meeting last year, we conducted a non-interventional study, intentional study intended to support the content validity of specific patient reported outcomes or PRO measures for subsequent clinical studies of Sildenafil Cream.The PRO content validity study which was completed in the third quarter of this year, 2019, was designed to identify and demonstrate which systems are the most important and relevant to our target population since these are the general arousal symptoms that we would want to assess in our Phase 2b trial in which subjects will use Sildenafil Cream and placebo cream in their home setting as well as our Phase 3 studies.Now that we have those results, the timing of initiation of the Phase 2b clinical trial will be influenced by the additional FDA guidance which we expect to receive prior to the end of 2019. In anticipation of that FDA guidance, we are conducting startup activities for the Phase 2b trial.In addition, we have performed and we will continue to perform additional clinical and non-clinical work that might be valuable or required to support the overall program such as the recently reported positive findings from a human clinical study using thermography to assess the pharmacodynamics of Sildenafil Cream in healthy women. The findings showed a statistically significant increase in genital temperature, a surrogate for general blood flow for Sildenafil Cream when compared to placebo and demonstrated that Sildenafil Cream elicits a quantifiable general response within 11 to 15 minutes of application. This study of six women also demonstrated statistically significant differences between Sildenafil Cream and placebo on measures of self-reported arousal. This is meaningful because self-reported arousal will be a component of the primary endpoint of the Phase 2b study.Before I turn the call over to Lisa Walters-Hoffert, our CFO, I would like to reiterate that we believe each candidate in our portfolio, those mentioned here today as well as those we did not discuss, has the potential to become either a first-line therapy or first-in-category solution or both and delivers on our mandate to address persistent unmet need in women's health,I will now turn the call over to Lisa to review our financials.

[Lisa Walters-Hoffert:]

Thanks Sabrina and thanks to all of you for participating on this update call. I would now like to summarize Daré's financial results for the third quarter ending 2019. As previously noted, Daré's primary operations have been and are expected to continue to be research and development to advance our portfolio of product candidates through clinical development and ultimately regulatory approval.During the quarter ended September 30, 2019, our expense included general corporate overhead, portfolio maintenance in the form of licensing fee accruals and expenses for research and development to advance these candidates towards clinical milestones. Daré's general and administrative expenses were approximately $1.3 million and our research and development expenses were approximately $2 million for the quarter. Most of our R&D expenses fell into the buckets that Sabrina just discussed, the Ovaprene and PCT clinical trial or to prepare for the initiation of the Phase 3 study of DARÉ-BV1, activities to advance our other programs and personnel costs.Our comprehensive loss for the quarter was approximately $3.4 million. We ended the third quarter with cash of approximately $2.4 million, 16.8 million common shares outstanding and approximately 3.7 million warrants to purchase shares of our common stock and no debt.As Sabrina mentioned, this past Monday and as disclosed more fully in footnote 11 of our 10-Q filed on Tuesday, Daré announced that it entered into an agreement and plan of merger with Microchips Biotech whereby if the merger closes, Microchips will become a wholly-owned subsidiary of Daré. This merger is expected to close on or before November 22, 2019.In addition to acquiring an exciting technology platform, a relationship with the Gates Foundation and a seasoned development team to complement our own at the time of closing, we expect Microchips cash and cash equivalents to be approximately $6.9 million and approximately $5.7 million of cash after the payment of transaction-related expenses. At closing, Daré will issue three million shares of its common stock in consideration of the cash and cash equivalents of Microchips plus liabilities and issue those shares to Microchips stockholders which, as Sabrina has just mentioned, include Polaris Venture Partners, MS Pace, Intersouth Partners and Teva Pharmaceuticals. We are thrilled to add these fundamental healthcare funds to our investor base.In addition, Daré has agreed to pay future contingent consideration for the achievement of specified funding, product development, regulatory and commercial milestones as well as tiered royalty payments. We expect that less than $1.3 million of this contingent consideration will become payable through the end of 2021. And such payments may be paid at our option in shares of our common stock or cash, subject to compliance with NASDAQ rules.In our recently filed 10-Q, we also noted that Daré continues to have a going concern as our existing resources will not be sufficient to fund our planned operations through November 2020. Again, we encourage our investors to review the more detailed discussion in our 10-Q file with the SEC on Tuesday relating to our definitive merger agreement with Microchips and our liquidity and capital resources and financial condition.I would now like to turn the call back to Sabrina.

[Sabrina Martucci Johnson:]

Thank you Lisa. So we continue to view 2019 as a transformational year for Daré and we believe we are well positioned to continue to create and capture value from our portfolio of women's health product candidates, particularly as we go into 2020 with the planned DARÉ-BV1 Phase 3 study initiation and the readout, Sildenafil Cream Phase 2b study initiation and Ovaprene pivotal study initiation. I also want to add that we continue to have productive conversations with potential strategic partners for our late and mid stage assets and we are encouraged by the number of companies that have indicated interest in one or more of our programs.As we have discussed, we will continue to evaluate those collaboration opportunities and the timing of such, partnerships in context of what we believe will drive the greatest value for our shareholders. Importantly, we believe that the level of interest in our portfolio from potential strategic partners from our earlier stage programs to our mid or late stage assets position us well to drive significant value in both the short and long term for investors and most importantly for women as well.We will now turn it over to the operator who will open the lines for Q&A.

[Operator:]

[Operator Instructions]. Our first question comes from the line of Yasmeen Rahimi with ROTH Capital Partners. Your line is now open.

[Rachael Yang:]

Hi. This is Rachael Yang, on for Yasmeen. Thank you for taking our questions. So first, can you walk us through how you determine acquisition of assets? What type of assets do you believe fit well within your current pipeline?

[Sabrina Martucci Johnson:]

Yes. Thank you for that question and the opportunity to give some clarity on that. So as we think about assets to add to our portfolio, they really have to meet four minimal criteria and ideally even more than that as the Microchips hit on a number of those. So first and foremost, they have to clearly address a persistent unmet need, because what's interesting to us is to add assets that have meaningful commercial viability and so that really means that they have to be addressing the needs that is not currently addressed today.Second, we love a program that has existing data and proof of concept and ideally even human proof of concept. Third, programs that have an opportunity to leverage an interesting regulatory pathway that we know from other areas really reduces your risk, meaning a 505(b)(2) pathway, are very, very interesting to us and that ties into our fourth category of importance which is, we look for programs that are really delivering products in ways that are unique for her and often that take advantages sometimes of unique female biology so that we can enhance convenience in outcome by sometimes avoiding systemic, meaning oral drug delivery.And so Microchips is a wonderful example of a technology and an opportunity that hit on all four those really important criteria. But beyond that, really went above and beyond, the incredible relationships that, kudos to the team at Microchips, that they had formed with the Bill and Melinda Gates Foundation to have the kind of support that the foundation has provided for that program is obviously a relationship that we are really thrilled to now personally have as a company and to take that program forward with that and an opportunity to have a program like this, as John and Lisa both noted in their comments, are funded, the next phases of development are funded. So it doesn't take away from other programs and other activities that we have here is a plus.And boy, icing on the cake is, it was a really wonderful opportunity to be able to in exchange for that cash that they have on hand to be able to issue our shares to investors like theirs that are now going to be Daré investors and that's really exciting for us as well. So hopefully that answers your question.

[Rachael Yang:]

That's very helpful. Thank you so much. And I have a follow-up. Can you walk us through how you plan on financing the Ovaprene Phase 3 program and which components of the trial designs are set in stone and which are up to negotiation?

[Sabrina Martucci Johnson:]

Yes. So thanks for that opportunity. I think I will use that opportunity to highlight some of the comments I made in my kind of closing remarks before we entered into Q&A. So we are very, very fortunate and I think it speaks to the work we have done to build a preeminent portfolio in women's health, the products that truly address persistent unmet need. We have been very, very fortunate to have productive conversations with potential strategic partners with a number of companies that have indicated interest in one or more of our programs and certainly Ovaprene is a program of interest given the opportunity it has to be such a potentially disruptive technology in the contraceptive category.But as I also mentioned, we are going to continue to evaluate these collaboration opportunities and really make a decision around the type of partnerships and the timing of such partnerships in the context of what we believe will drive the greatest value for our shareholders. So we look forward to keeping you updated on our progress on that and on the interest that we have across our portfolio.As it pertains to the clinical development program, filing an IDE is really our first opportunity and that process around an IDE filing is Daré's opportunity, really our first opportunity, to engage robustly with the FDA around that clinical development program. We obviously know from other products that have gone through that same division of the FDA, what they have typically done in their, what they have been required to do in their pivotal programs. Typically, it's been one pivotal study, six months in duration and evaluating up to about 250 subjects as completers at the end of that six months. So that's what's happened with other products.Obviously, Ovaprene is a very brand-new category of product. That's why it's so exciting and so interesting. It's the first once-a-month, hormone-free product. Everything else that's gone through that division of the FDA has been a spermicide, on-demand, a condom on-demand, a diaphragm on-demand. So we are really looking forward to having these interactions now with the FDA and providing clarity and guidance as we move forward on that program.

[Rachael Yang:]

Great. Thank you so much and congrats on your progress.

[Sabrina Martucci Johnson:]

Thank you.

[Lisa Walters-Hoffert:]

Thank you.

[Operator:]

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

[Joanne Lee:]

Hi guys. This is Joanne Lee, on for Jason. Thanks for taking the question. Regarding the acquisition of Microchips Biotech, I was wondering if you could go over some of the details on the ongoing contraceptive implant program, which I understand is being fully funded? And then some further guidance on its pathway to approval?

[Sabrina Martucci Johnson:]

Yes. So that development program is still in the preclinical stage. The technology has been through a human study which is, like I say we like products that have been through proof of concept to show kind of proof of concept for the technology within the contraceptive areas in the preclinical stage of the development and really at this stage in a development program, there is really two core focus areas of activities. One is obviously around the technology itself and optimizing the device design and the release profiles and things like that.So typically as you would do for any, think about any kind preclinical program and often what you are doing at that phase in development as you are preparing to go into human clinical studies. So that really includes the animal work as well as design work that would be done at this stage in the development program. As well as it's a great opportunity to also do market research with women to really understand how she would like to use a technology like this to make sure we are achieving all those design objectives. So that hopefully gives you a sense of how we are thinking about these next phases of development.I am trying to remember if there was more to your questions.

[Lisa Walters-Hoffert:]

Yes. And you did ask about the funding. So in our press release and in the Q, we announced that they had, there was available funding up to $20.5 million. Approximately $17.9 million, so call it $18 million has been issued and granted to date. So there is another $2.5 million, which as Sabrina noted, if received will fund their operations into 2021. so what's nice about that program is it did come with existing funding which was a great opportunity for Daré.

[Sabrina Martucci Johnson:]

And really to fund those next female phases of activity including that animal work.

[Jason McCarthy:]

Okay. Hi guys. This is Jason. I am actually on the call too. I just wanted to jump in with another question. I don't if you are aware, just like an hour ago, Agile's hormonal contraceptives, they got the PDUFA extended all the way till February, I think which was unexpected. Can you discuss just a little bit may be your views on the FDA's willingness or efforts to really bring more women's health products and specifically contraceptives to approval and into the market?

[Sabrina Martucci Johnson:]

Yes. It's a great question. Thank you for giving us the opportunity to talk about the field and I think frankly it also gives us an opportunity to talk a little bit about our business model at Daré. So as we talked about our portfolio and this is true whether I am talking to you about BV1 or Ovaprene or Sildenafil Cream or I can keep going, we have worked and the Microchips program, we have worked very, very hard as we have designed and built our portfolio to achieve a couple of objectives. One being, I didn't mention but I probably should have on the call, it's an n interesting portfolio design. Because we constantly while we are hitting our operational targets and milestones for you all investors, we are also, it's kind of tiered as you think about data, clinical and regulatory kind of events across the portfolio. So I think 's is interesting in a portfolio structure.But to your specific question about the FDA and their interest in approving products for women. We strongly believe that they absolutely are interested in approving products for women and ensuring that women have products to address clearly defined persistent unmet needs. And I can speak to our sildenafil program. As you know we had a Type C meeting last year. We are having ongoing discussions obviously with the agency which is why we feel we will have clarity as we go into the year.So there is definitely interest and enthusiasm working with sponsors to bring new products to market for women. So we as a company don't doubt for a second that willingness. I will say, from a risk and portfolio design perspective, we have tended to lean towards again areas where there is a very clear persistent unmet need, meaning that there is no other product in the category that could be considered to be exactly or even marginally equivalent to our program, right.So BV1, one-time administration of clindamycin. So while there's other clindamycin creams and while there is even another one-time cream, it's a cream. It's not a clear gel. This is a bioadhesive. If you look at Ovaprene, it's the first ever hormone free once a month contraceptive. If you look at sildenafil, it's the first product being developed for arousal disorder where there is nothing else in the category approved.And while that, I do not mean to imply in any way that means anything as a slam dunk, right, you always have to work with the agency and your product in the end, the benefits have to outweigh the risks, it's definitely a certain type of conversation with the agency where they are looking at a category where there is nothing else available for someone as opposed to when they are looking at a category and there is a perception that there may be something similar enough that your offering isn't quite as differentiated.So why don't I end it there because we are 100% rooting for Agile and really want to see them be successful because we do think that their product is interesting and that it will be an important and nice addition to the armamentarium that's available today. But hopefully, that gives some context for us, for Daré how we built our portfolio and how we are looking at our FDA interactions.

[Jason McCarthy:]

Okay. Great. Thank you Sabrina.

[Sabrina Martucci Johnson:]

Yes.

[Operator:]

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

[Jason Kolbert:]

Hi guys. Thanks so much. Most of my questions have been answered. But what I would like to focus on two areas. One is, Lisa, you talked about the fact that you spent $3.4 million in the quarter. You ended with $2.4 million in cash. Plus the acquisition, essentially is a finance, a non-dilutive financing. Help me understand, all other things being the same, what your cash runway looks like today?

[Lisa Walters-Hoffert:]

Yes. And thanks for the question. We don't provide specific runway guidance because on a quarterly basis or even on an annual basis. We did say we don't have through 2020 of November of next year. But as you pointed out though that, the $2.4 million and then the net $5.7 million that we acquired, some of that's going to go to cover the Microchips ongoing research and development activities, preclinical that Sabrina described. But the excess funds, we can use. We will be acquiring them. So I wish I could be more specific, but that's kind of as much as I can say right now.

[Sabrina Martucci Johnson:]

Yes. And I think what I would add to that, Jason and thank you for asking that question because one of the things we are very proud of as a company and I think again it bodes well for our investors, if you look at how much we have accomplished with how little we spend is we are incredibly capital efficient and really try to focus our spend on things that can drive value inflection. So most of the money we bring in goes to clinical and regulatory milestones events. And we leverage grant funding wherever we can. So the Ovaprene program is really to this point essentially funded by the NIH, which we are incredibly thankful for the support of the NIH for that program.So I think what you can see going forward is that we are very, as a company culture we are very capital efficiency minded and I think what you can expect from us going forward is that same sort of low overhead burn that we have showed historically and that we will continue to be creative in funding sources like the Gates Foundation opportunity around Microchips, the NIH opportunity that we have had around Ovaprene and as we look at forward-looking continue to be as creative as we can in terms of funding strategy to achieve as much as we can with as much non-dilutive capital as possible and when we are using equity capital that we are incredibly mindful in how that spends and that it's really driving value.

[Jason Kolbert:]

Good. And I get that and I think that comes through and I think that's an important element of the acquisition that you made. So I understand that. Can we talk a little bit about the linkage between business development and kind of the up and coming proof of concept status, if you will, of Ovaprene, BV1, sildenafil? And kind of just individually next catalyst, where you are on proof of concept and what the BD level of interest is on those three programs in particular?

[Sabrina Martucci Johnson:]

Yes. I can't stress enough and I will put it on all bold, better if I could, just how incredibly fortunate and frankly validating it is to see the level of interest that we continue to have in our portfolio really across the programs and the interest that there has been in the programs. We just came back from BIO-Europe. We are always doing these kinds of partnering meetings, John and I. And so we are super excited about that level of interest. And we are having that level of interest right now in the portfolio because, to your point, we have got three programs, each of which is at an interesting value inflection point.Ovaprene having reported out the kind of data that we just reported, given the field the PCT studies and how robust our PCT study is and how predictive these kind of studies are of highly effective contraceptive methods, clearly being the first potential monthly hormone-free contraceptive, lots of interest in Ovaprene obviously. But the same goes for our BV1 program and our sildenafil program. I mean BV1 with the level of effectiveness that it has the potential to deliver and how quickly and efficiently, to your point, we can get through that Phase 3 and have a clinical readout in 2020, which is an important milestone for that program around a commercial partner obviously is going to want Phase 3 data and the NDA filing. For a program at that stage of development that's a really interesting milestone that we have coming up right in 2020.And for our Sildenafil Cream, getting through these discussions that started last year with the FDA and that we are continuing this quarter, that's an important milestone for the Sildenafil Cream program that I can't emphasize enough. This is the first potential product for treatment of female sexual arousal disorder, which is her version of erectile dysfunction. There are actually more women with arousal disorder than there are me with erectile dysfunction and they are just as distressed and just as motivated. And getting through the discussions with the FDA which provides clarity for the Phase 2b and Phase 3 program is a really important event for that program as will be getting through that Phase 2b study. Once we get through that Phase 2b study, really, hopefully demonstrating success against those patient reported outcomes of general arousal sensations that's an incredible milestone for the company and we are planning on running that study in 2020.

[Jason Kolbert:]

Congratulations on all the progress. It's really exciting. I have to believe that the BD level of interest among specialty pharma and even some of the large pharmas have got to be really, really high. It would be interesting to see a deal come together.

[Sabrina Martucci Johnson:]

Thank you.

[John Fair:]

Thank you.

[Sabrina Martucci Johnson:]

We feel the same. So like I said, it's very validating to have the kind of interest that we have.

[Operator:]

Thank you. Our next question comes from the line of Jim Molloy with Alliance Global Partners. Your line is now open.

[Jim Molloy:]

Hi guys. Thanks for taking my question. I had a quick question on the Microchips, following up on that a little bit. Could you talk a little about what the extent the costs are to get to the next key catalyst and the cash that comes in and the potential for additional cash from the Bill and Melinda Gates Foundation? Does that cover it? Or will there be a need for additional capital? And is there an option for the Bill and Melinda Gates Foundation kick in additional capital?

[Sabrina Martucci Johnson:]

Great. Great question. So as Lisa mentioned and I will reinforce that, the Bill and Melinda Gates Foundation, the funding level of the collaboration has been $20.5 million. Not all of that has already been received. So I think that's yes in answer. As she noted, about $18 million has come in to-date and there is about $2.5 million of ongoing funding that's already just part of that current grant agreement. Obviously we can't speak to what the future looks like but this certainly fits into the kind of programs that the foundation has been interested in supporting truly disruptive technologies in the contraceptive stage that allow the opportunity for a super highly effective contraceptive method. Implants are by far the most effective contraceptive method that gives her the ability to control her family planning and fertility. So we really look forward to that ongoing relationship and feel very good and that the activities really that we described and kind of getting through this next phases including the next phase of funding that can come in next year into that current grant really is sufficient to get to that point. And then obviously, upon success, we will look forward to continuing to secure funding as appropriate for that program.

[Jim Molloy:]

Right. My apologies. Of course, I mean in addition to the $2.5 million that's left on the current grant, but I guess we will see if that will come in or not. And I see on their website from a while ago, it looks like they had a deal with Teva from back in the day. Is that something that is ongoing? Or can you talk a little about Microchips' relationships?

[Sabrina Martucci Johnson:]

Yes. So the technology is really an interesting one that has a lot of utility and promise, as I mentioned kind of upfront, outside of the contraceptive field. The contraceptive field is a really great one actually to spend the time and effort on doing this kind of work on, because we know there are drugs that can release over long periods of time and are stable in that environments. So it's a great place to do kind of this stage of work on the program and think about as first indications. But there are absolutely other therapeutic areas.So Teva, at one point, was involved in the program and had some support for the program, as you noted and clearly also they are now an investor getting some of our Daré shares. So I think there are other opportunities like that for those kind of collaborations to continue to support the ongoing development of the program. And particularly as we think about other therapeutic areas, we are very focused on women's health obviously here at Daré but an implant like this is agnostic to gender.You can put an implant in men or in women. And so certainly hopefully from the answers we just gave around business development in general here at Daré, we are partnering, we are all about partnering appropriately and non-dilutive capital that these kind of opportunities bring. So we will absolutely also look at other areas where this technology could have utility and look for those kind of partnering opportunities as well.

[Jim Molloy:]

One last question, then I will hop back in the queue. One the BV1, you make clear you are looking for data for your Phase 3 top line in 2020. When do you have to start that trial by to get that 2020 data?

[Sabrina Martucci Johnson:]

Really, right now, the plans are, we are already doing a lot of the startup activities that are associated and the plan is actually to start the trial in 2020 and that timeline is what supports us having the data in that year. It's a relatively simply short study. So, as I mentioned, the primary endpoint visit is day 21 to 30. I should be clear that that pivotal study, not the extension study that I talked about, which goes out to another 60 days. But just that pivotal phase, that's day 21 to 30, that's the part that we need for the NDA filing. So you know, as you can the guess, given how short the study is, you can start the study. There is a lot of leeway on when to start the study in 2020 to have a data readout in 2020.

[Jim Molloy:]

Great. Thank you for taking the questions.

[Sabrina Martucci Johnson:]

Yes. You bet.

[Operator:]

Thank you. Our next question comes from the line of Brian Marckx with Zacks Investment Research. Your line is now open.

[Brian Marckx:]

Hi everybody. And congrats on all the progress. Sabrina, I wondered on BV1, whether there is any regulatory or site or patient signoffs that you need before you can start that study?

[Sabrina Martucci Johnson:]

Yes. So great questions. So as we had mentioned in the past that that program, one of the things that we had do as a company was file our own IND, because the prior work had been investigator initiated. So we have to file a Daré IND. So that's obviously an important step in the program and the timeline that we talked about reflects that process of the IND filing and clearance.And then yes, an important thing in a study like this is obviously the patient consents and particularly in a study this one where they have an active infection and they are going to get an investigational treatment. So a big part of operationally, successfully running a study like this is setting appropriate expectations around when they can have something else, if our product or placebo, that's what you really worry about in these studies because patients are going to be randomized to placebo and you want to give them comfort that don't worry, we will you give something if you are randomized to placebo over time to manage your infection.And so operationally, those important discussions and consent is a piece of it. And so as we look at starting up that study, part of the activities that, for instance, one does now before you literally get going is look at obviously all those protocol considerations you have to take and to make sure that you are going to be able to roll the right kind of women and keep them in and get them comfortable that they are going to have treatment.But a big piece of it is enrolling the right sites. And fortunately, there have been other BV studies. We have a good sense of who the sites need to be in the United States and that have really good experience with these kind of infectious disease type studies where you really have to have a placebo control but want to make sure that women have stay in and that they are going to get treatment over time, if they were randomized to placebo. So thanks for asking about that.

[Brian Marckx:]

Yes. I appreciate the detailed answer. Relative to the extension study of the BV1, is that a certainty that you are going to run the extension portion of it? Or is that a, to be determined? And then also on that, are those results some thing, you do conduct that portion of it, something that you will announce? You are certain that you will announce?

[Sabrina Martucci Johnson:]

Yes. Thanks for asking that clarifying question. So right now, the intent is to conduct the extension study. It's something that we have looked at based on work we have done with payors, work we have done with and were be done with, to some of the earlier questions on potential partners, right, potential commercial partners for this program. What might be interesting for them to see that really helps differentiate the program. So as this program progresses, we will continue to provide clearer and clearer kind of guidance, as we did with Ovaprene, if you think back to that program on when we are going to have different clinical readouts, when things are starting.But right now, given how inexpensive that component of this study is, again I refer you to the Q. It has really nice detailed information around the clinical program and the cost. But given the low incremental cost for that extension study but the significant upside it can provide in terms payor, relationship of payors and potential partners, it certainly is in our plans and we look forward to being able to get some clear guidance on exactly when we would expect that data as well.

[Brian Marckx:]

Okay. Great. Thank you.

[Sabrina Martucci Johnson:]

Yes.

[Lisa Walters-Hoffert:]

Thanks Brian.

[Operator:]

Thank you. Our next question comes from the line of Suzanne Maloney [ph] with Catalysts Partners. Your line is now open.

[Unidentified Analyst:]

Hi. Thanks so much for the update and congratulations on the successful completion of the Ovaprene postcoital study. I share your enthusiasm for the asset. I was trying to keep track the different license fees that you guys have to pay and I was curious whether any of the licensing fees to ADVA kick in now that you have successfully completed the postcoital study?

[Sabrina Martucci Johnson:]

Yes. We haven't given that level, thanks for the question, typically for competitive reasons, we don't give that level of guidance. We request confidential treatment with the SEC when we file our agreement so that specific timing of milestone events and what are those specific to the milestone events is not disclosed. So we really never be in a position, at this point in the process, to give that level of specificity around what might trigger a milestone payment and what it might be. What we have disclosed however because we understand it's important for investors and people interested in the company to understand is what in aggregate the milestones, both clinical and commercial, might look like. I have to admit I don't have it right in front of me but we did disclose for that program is, I can look it up quickly, I think it's under --

[Lisa Walters-Hoffert:]

I think it's about $14 million.

[Sabrina Martucci Johnson:]

Yes. It's about --

[Lisa Walters-Hoffert:]

I am sorry. I am going to jump in here. About $14 million and we tried to break this down between clinical, regulatory and commercial because you lump them all together and it gets to the -- yes.

[Sabrina Martucci Johnson:]

Even for people, I guess, all of us.

[Lisa Walters-Hoffert:]

Yes.

[Sabrina Martucci Johnson:]

Yes. So it's about $14 million to $15 million.

[Lisa Walters-Hoffert:]

Right.

[Sabrina Martucci Johnson:]

Of clinical. And that's again for competitive reasons, that's the only disclosure we have given.

[Unidentified Analyst:]

Okay. And all my other questions have been asked and answered. So that was the only one I had left.

[Lisa Walters-Hoffert:]

Thank you.

[Sabrina Martucci Johnson:]

Thank you.

[Unidentified Analyst:]

Thank you.

[Operator:]

Thank you. Our last question comes from the line of Nathan Weinstein with Aegis Capital. Your line is now open.

[Nathan Weinstein:]

Hi. Thanks for taking my question and there were definitely some good questions asked before. And so actually what I was hoping to ask was on a macro level, looking at the women's health market. In terms of the investment activity you have seen, how the market in general is growing? And then in particular, whether over time you guys have seen greater interest from ESG-focused investment funds in this space? Thank you.

[Sabrina Martucci Johnson:]

I am not sure I understood the last part of the question.

[Nathan Weinstein:]

ESG?

[Sabrina Martucci Johnson:]

Can you repeat, Nathan? I am sorry to make you repeat it. But could you repeat it?

[Nathan Weinstein:]

Yes. Can you hear me now?

[Sabrina Martucci Johnson:]

Yes. Thank you. If you could repeat it, that would be awesome. Thank you.

[Nathan Weinstein:]

Yes. So the last part of the question was, over time, whether you have seen greater interest from ESG-focused investment funds with you guys in the space in general?

[Sabrina Martucci Johnson:]

And Nathan, define ESG, just to make sure we are thinking about this properly.

[Nathan Weinstein:]

So ESG would be environmental, social --

[Sabrina Martucci Johnson:]

Got it. We thought that that's what you were referring to. Yes. So it's interesting because at Daré as a company receives a little more visibility and people understand the impact of the work we are doing. That is a category of investors that is interesting and intriguing to us. And in fact, I did go and attend the social capital impact investor's conference in San Francisco in September, SOCAP, which is really an interesting opportunity to get in front of investors that have that mandate. It's interesting because we don't fit totally neatly into the buckets that they typically invest in because often it's environment or things like that. But they had a healthcare sector representation at that conference and it really was an interesting opportunity to understand the funds that are looking for things like this. And I think given our focus in women's health and there are some other interesting aspects of Daré as a company that's often appealing to these kind of funds which not only are women's health focused, but a female CEO, majority female Board as a publicly traded company, we tick some interesting boxes for funds that are looking for an investment that feels very good to them. So we are really pleased that we starting to get some notice in those circles as well. So thanks for asking that question.

[Nathan Weinstein:]

Yes. Thanks for the perspective.

[Sabrina Martucci Johnson:]

Yes.

[Operator:]

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

[Sabrina Martucci Johnson:]

Well, thank you. And I really want to appreciate everyone's time this afternoon and particularly the really thoughtful questions that we got today because I think there are great opportunity for us hopefully to provide a little more clarity around our portfolio, our programs, our partnering opportunities, our strategies, our upcoming clinical and regulatory advance not only this year but as we go into next year as well. And with that in mind, we are absolutely looking forward to keeping you updated on our progress. So thank you all.

[Operator:]

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.