Daré Bioscience, Inc. (DARE) CEO Sabrina Johnson on Q4 2018 Results - Earnings Call Transcript

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

Daré Bioscience, Inc. (NASDAQ:DARE) Q4 2018 Earnings Conference Call April 4, 2019 8:30 AM ET

Company Participants

Sabrina Martucci Johnson - President and CEO

Lisa Walters-Hoffert - CFO

John Fair - Chief Business Officer

Conference Call Participants

Yasmeen Rahimi - ROTH Capital Partners

Caroline Palomeque - Maxim Group

Brian Marckx - Zacks Investments Research


Welcome to the conference call hosted by Daré Bioscience to provide Financial Results for the Quarter Ended December 31, 2018, and a General Business Update. This call is being recorded. My name is Chris, and I’ll be your operator today.

With us today are Sabrina Martucci Johnson, Daré’s Chief Executive Officer; Lisa Walters-Hoffert, Daré’s Chief Financial Officer; and John Fair, Daré’s Chief Business Officer. Miss Johnson, please proceed.

Sabrina Martucci Johnson

Thank you. Welcome to our financial results and business update call for Daré Bioscience. It’s a pleasure to have the opportunity to talk about our 2018 results, our company highlights and upcoming milestones for 2019 and 2020.

Before we begin, I would like to remind you that today's discussion will include forward-looking statements within the meaning of Federal Securities Laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties.

You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company’s SEC filings, including our annual report on Form 10-K for the year ended December 31, 2018, which was filed earlier this week on Monday April 1st.

I'd also like to point out that the content of this call includes time sensitive information that is current only as of today, April 4, 2019. We undertake 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 wellbeing of women, primarily in the areas of contraception, vaginal health, sexual health and fertility. Our vision is to become the premier innovation accelerator in women's health. We achieve these by identifying, unlocking and advancing candidates with potential to be first-in-category, address persistent unmet needs and promote a better quality of life for women.

2018 was a transformative year for Daré, as we moved closer to our goal of building a preeminent company in women's health. During the year, we began to execute on our licensing, partnering and value creation strategy by adding to our portfolio, targeting areas where large numbers of women have needs that are not being sufficiently addressed, and where true innovation is required. We ended 2018 with a differentiated portfolio that we believe is well-positioned to drive upside.

Specifically, our strategy has been to build a portfolio with product candidates we believe are commercially viable and attractive to strategic partners, have a data package including a proof-of-concept study, and/or the ability to leverage the 505(b)(2) regulatory pathway, have the potential to be first-in-category and that address persistent unmet needs in women's health and have the ability to deliver products in a more personalized way for women.

We expect to deliver against multiple milestones over the next 12 to 24 months, including advancing our DARE-BV1 Bacterial Vaginosis or BV program into a Phase 3 clinical trial; announcing topline readouts from our two pre-pivotal programs, our ongoing post-coital test clinical study in Ovaprene in the second half of this year, 2019, and our planned Phase 2b clinical study of Sildenafil Cream in the fourth quarter of 2020; and moving preclinical programs into Phase 1 clinical development, including DARE-HRT1, an intervaginal ring or IVR that combines bio-identical estradiol and bio-identical progesterone to treat the vasomotor symptoms associated with menopause, as part of a hormone replacement therapy.

DARE-FRT1, a bio-identical progesterone, IVR for fertility and pregnancy maintenance and DARE-VVA1, vaginally administered tamoxifen for the treatment of vulvar and vaginal atrophy or VVA in patients with hormone receptor positive breast cancer.

I'd like to provide an update on some of these programs, summarizing both our accomplishments to date and our expectations for 2019. In addition, my colleagues, Lisa and John will provide a financial update and an update on our strategic partnering strategy.

First, Ovaprene, Ovaprene is a novel vaginal ring that has the potential to disrupt the contraceptive space by being the first non-hormonal women initiated contraceptive approved by the U.S. Food and Drug Administration or FDA, that is not in the moment or daily, and rather can be used on a cycle by cycle basis, giving women greater flexibility and control with the potential for efficacy approaching that of hormonal contraceptives.

As a reference, the first monthly hormonal vaginal ring, NuvaRing disrupted the contraceptive space in 2017, achieved 760 million in global sales. The Ovaprene post-coital test, or PCT clinical trial has proceeded as expecting and top line data are expected in the second half of 2019 this year. If positive we intend to prepare and file an investigational device exemption, or IDE with the FDA in order to commence a pivotal clinical trial with Ovaprene in 2020.

In March of this year, 2019, we received a notice of award for the second tranche of an NIH grant in the amount of over $982,000, bringing the total awarded to-date to slightly over $1.2 million. Grant funding is a form of non-dilutive capital that serves to offset our development costs and core to the Dare model, given our focus on persistent unmet needs to women's health, is to apply for and leverage that non-dilutive funding support, whenever feasible. We're thrilled to have the financial support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, a division of the NIH.

Sildenafil Cream, 3.6%; Sildenafil is the active ingredient in Viagra. Sildenafil Cream is a topically administered formulation of Sildenafil, designed to increase local blood flow and provide a potential improvement in genital arousal response and overall sexual experience for women. It has the potential to be the first product approved by the FDA for female sexual arousal disorder, or FSAD.

FSAD is the closest analogue in women to erectile dysfunction in men, a lack of physiological response. Our proprietary Sildenafil Cream formulation is specifically designed for use on demand, when she needs it, in a similar manner to Viagra for erectile dysfunction but as a topical cream versus an early administered product to minimize systemic exposure. Today, there are no FDA approved options for treating female sexual arousal disorder.

Last summer we met with the FDA to align on the development path forward for Sildenafil Cream. Based on that discussion, we're currently completing a non-interventional study intended to support the validity of specific patient reported outcome measures to assess efficacy of Sildenafil Cream and at-home portion of our Phase 2b clinical program. This study is an opportunity to get real world patient feedback on our proposed primary endpoint questions to ensure that women understand the questions and that we capture the symptoms that are most important and relevant for FSAD patient.

At the completion of the study this year, we will request a Type C meeting with the FDA to get feedback on whether the agency agrees that our proposed patient reported outcome questions are content valid for the target population, and to align on the endpoints for the at-home portion of the Phase 2b where women will have an opportunity to use the investigational product, as well as the Phase 3 program, such that the Phase 2b can be predictive to investors and potential corporate partners.

The timing of when we initiate the Phase 2b at-home trial will be influenced by the guidance we get from the FDA. Currently, we expect to commence the at-home portion of the Phase 2b by the end of 2019. And based on that timeline, we would expect to report top line data by the end of 2020.

Now transition to DARE-BV1, in December of 2018, we licensed the right to our third clinical candidate DARE-BV1 for bacterial vaginosis. DARE-BV1 is a proprietary solution to gel formulation, containing the antibiotic clindamycin and it's engineered to be administered in a single vaginal dose.

BV is the most commonly reported vaginal infection in women aged 15 to 44. The prevalence is estimated to be approximately 21 million women in the U.S. aged 14 to 49. With clinical cure rates currently ranging from 37% to 68%, current FDA approved prescription drugs for BV are not optimal. Thus there is significant opportunity for upside and market expansion, as evidenced by the most recent transaction in the category. Lupin, a subsidiary of -- India-based Lupin acquired Symbiomix, a maker of a novel antibiotic granular powder for the treatment of BV in a transaction valued at $150 million.

We believe the DARE-BV1 Phase 3 program will allow us to move into a leadership position in an area of great concern for both women and health care providers. If a clinical cure rate consistent with the pilot study, or 88% is demonstrated in the Phase 3 program, DARE-BV1 has the potential to provide a significant improvement in efficacy over currently marketed BV therapies. Further because BV is a vaginal ailment, many women and health care providers prefer a treatment administered directly to the infection site over treatments taken orally. This is particularly true for antibiotics, given the potential unwanted side effects that accompany oral systemic administration.

We're preparing an IND for DARE-BV1 which we will need to file with the FDA in order to commence the Phase 3 clinical study as planned by the end of 2019. Commencing the study in the fourth quarter this year also gives us an opportunity to seek trial design feedback beyond the minimum requirements for FDA approval from key opinion leaders and the potential commercial partners that have expressed interest in the program. Following completion of Phase 3 study in approximately 250 women and assuming a successful outcome we'll seek to file a new drug application with the FDA in 2020.

DARE-HRT1, this is our fourth clinical stage candidate, due to end our Phase 1 clinical study this year. DARE-HRT1 is a combination of Bio-identical Estradiol and Bio-identical progesterone. It's an intervaginal ring for hormone replacement therapy following menopause. This novel IVR technology was originally developed by Dr. Robert Langer from MIT, and Dr. William Crowley from the Massachusetts General Hospital and Harvard Medical School.

DARE-HRT1 is being developed for hormone replacement therapy or HRT, to treat vasomotor symptoms or VMS, commonly called hot flashes and associated with menopause, as part of an HRT regimen. The North American Menopause Society or NAM consensus statements supports HRT in pre and post-menopausal women and recommends administering both estrogen to reduce symptoms and progesterone together to prevent thickening of the uterine wall in addition to recommending a non-oral route over an oral route.

The design of DARE-HRT1 is intended to allow the continuous delivery of bio-identical estradiol and bio-identical progesterone in one vaginal ring over a 28-day period. With more than 45 million women approaching menopause in the U.S., the demand for new innovation to treat VMS is accelerating at a rapid pace.

Our intention is to commence a Phase 1 study of DARE-HRT1 in approximately 30 women in Australia this year. We believe conducting a study in Australia will be cost efficient as we can leverage our existing subsidiary and its opportunity for a cash rebate of over 40% of the research expenses incurred in Australia. In addition, we expect to advance our novel IVR-based fertility program DARE-FRT1 into a human clinical study in approximately 12 to 18 months.

And finally, I'll talk about DARE-VVA1. And before I turn it over to Lisa, I want to summarize the results highlighted in the 2019 publication of clinical findings for Vaginal administered of tamoxifen in clinical and experimental obstetrics and gynecology. DARE-VVA1 is a proprietary formulation of tamoxifen for vaginal administration. It has the potential to be the first treatment specifically approved for the treatment of vulvar and vaginal atrophy in patients with hormone receptor positive breast cancer.

VVA is a chronic condition characterized by pain during intercourse, vaginal dryness and irritation. Most women used localized estrogen therapy, which is contra-indicated for the more than 2 million women diagnosed with risk of occurrence of hormone receptor positive breast cancer. We intend to develop this novel application of tamoxifen to mitigate the symptoms of VVA for patients risk or at risk for hormone receptor positive breast cancer, including women currently on anti-cancer therapy.

In fact, due to the aromatase inhibitors for the treatment of hormone receptor positive breast cancer, the prevalence of the VVA in breast cancer patients is reported to be up to 70%. A recent publication reported that a self-administered vaginal suppository containing tamoxifen administered to four healthy postmenopausal women with the VVA showed significant improvement in reducing vaginal PH and vaginal dryness without significant systemic absorption of tamoxifen.

We believe each of the candidates in our development portfolio has the potential to deliver a first-line therapy or first in category product, addressing a persistent unmet need in women's health. Before I summarize the upcoming milestones, I want to turn it over to Lisa and John to review financials and strategic partnerships.

I'll first turn it over to Lisa Walters-Hoffert, our CFO.

Lisa Walters-Hoffert

Thanks, Sabrina, and good morning everyone, and thank you for participating on this update call. I would now like to summarize Daré's results for the year ended December 31, 2018. Our primary activities have been and will continue to be focused on the research and development activities to advance our product candidates through value inflection and clinical milestones. Hence our financials do not include revenues, and instead consist primarily of corporate overhead, costs related to licensing or acquiring product candidates and research and development expenses.

During the year ended December 31, 2018, our general and administrative expenses were $4.7 million and our research and development expenses were $6.4 million. We incurred license expenses of $625,000 in connection with the expansion of our portfolio, including three innovative intervaginal rings from Juniper Pharmaceuticals, now Catalent and DARE-BV1 for bacterial vaginosis from Hammock Pharmaceuticals and MilanaPharm.

During 2018, we wrote off all of the goodwill that was created in connection with the merger transaction in 2017. And please note that the impairment charge of $5.2 million was a non-cash charge. I would also like to note that a comparison of our 2018 and 2017 financial results is difficult, given that we completed the business combination with Cerulean and Private Daré back in July of 2017.

So our financial statements for certain of the 2017 periods, actually represent the operations of Private Daré. In terms of non-dilutive sources of funding, as Sabrina mentioned, in 2018, we were awarded an NIH grant for up to $1.9 million in total, for the cost of Ovaprene post-coital test. In 2018, we were awarded and used the first tranche of approximately $225,000. On March 11 of this year we announced receipt of the second notice of award for an additional $980,000, bringing total awarded under the grants to date to $1.2 million.

Grant proceeds are recognized as a reduction to our research and development expenses. And we will continue to explore and apply for non-dilutive capital across our portfolio. Daré ended the year with approximately $6.8 million in cash. Our balance sheet consisted of 11.8 [ph] million common shares approximately 3.7 million warrants to purchase shares of our common stock and no debt. Management and our Board currently own over 20% of shares outstanding.

We believe our current resources are sufficient to fund our operations into the third quarter of 2019. And while we believe we are capital efficient, as we execute on our planned operations this year and move our clinical candidates forward, we will need to access additional capital and will continue to seek it from multiple sources. These include but are not limited to grants, foundation funding, collaboration agreements, and the issuance of equity.

On Monday, we announced that we were notified by NASDAQ that we had regained compliance with NASDAQ's minimum bid price requirement for continued listing. As a result that our closing bid price was greater than $1 for 10 consecutive business days. We were also notified that our previously reported non-compliance listening matter was now closed.

I would now like to turn the call over to John Fair, our Chief Business Officer.

John Fair

Thank you, Lisa. As Sabrina mentioned, 2019 is setting up to be a transformational year for Daré as we believe we are well positioned to capture value from our portfolio of women's health products. We are encouraged and excited with the level of interest and activity as it relates to our strategic partnering discussions. But we will remain very disciplined in our guidance and will only announce a strategic partnership or partnerships after we have arrived at a mutually agreed upon term and fully executed a transaction.

We continue to remain very bullish on the women's health sector. And we've seen a number of newcomers making significant advancements, both scientifically and commercially. And we remain encouraged that a number of larger companies are making direct investments and recommitting efforts to fully optimize the women's health portfolios.

As we've discussed in previous calls, and in numerous presentations, Daré has a strong commitment to the sector. We've been successful at identifying, acquiring and accelerating novel innovations, capable of addressing persistent unmet need, with a particular focus in the area of fertility management, which includes our contraceptive assets, as well as our progesterone ring for pregnancy maintenance, and overall vaginal health, which includes innovative products for FSAD, VBA, and VMS. We believe our business model, therefore is highly complementary to downstream strategic partners looking to create value by introducing new and differentiated products into these categories.

It's important to note that if approved, all of our products will be prescribed by OB/GYNs as the primary health care provider. So from a partner's point of view, they can maximize their commercial efforts by targeting this specific call point to create efficiencies as they take these products to market.

In closing, as Sabrina noted and part of our strategy we only acquire products that we believe are highly partnerable [ph], have an existing data package or regulatory advantage, or both, products that can be leveraged and delivered in a more personalized way for women, either through a vaginal ring, a topical cream, vaginal delivery by a gel or insert, and most importantly, products that address a persistent unmet need in their respective category.

We believe all of our products meet these four important criteria and therefore have the opportunity to make a meaningful impact on the health and wellbeing of women across a wide range of lifestyles and life stages.

With that, thank you for your time and your attention. I'll turn the call back over to Sabrina.

Sabrina Martucci Johnson

Thank you, John. We look forward to keeping you updated on the milestones expected in 2019 from Ovaprene and Sildenafil Cream programs, each of which has the potential to deliver a first in category product, addressing a persistent unmet need in women's health, as well as from our DARE-BV1 program in bacterial vaginosis and our IVR programs in hormone replacement and pregnancy maintenance; Vaginal tamoxifen for VBA and hormone receptor positive breast cancer as well as our long acting injectable contraceptive program and the CatSper contraceptive target.

Together these programs constitute arguably the most differentiated portfolio in women's health, and one that we believe is well-positioned to drive significant value in both the short and the long term.

As I mentioned at the beginning of the call, we expect to deliver against multiple milestones over the next 12 to 24 months, including advancing our DARE-BV1 bacterial vaginosis program into the Phase 3 trial, announcing top line readouts from our two pre-pivotal programs with potential to deliver first in category products, specifically our Ovaprene PCT trial in the second half of this year and the at-home portion of the Phase 2b study of Sildenafil Cream, in the fourth quarter of 2020; and moving three additional programs with first-in-category potential into Phase 1 clinical development, our HRT1 program this year and FRT1and VVA1 in 2020.

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

Question-and-Answer Session


Thank you. [Operator instructions] And our first question comes from the line of Yasmeen Rahimi with ROTH Capital Partners. Your line is now open.

Yasmeen Rahimi

Hi, team. Congrats on the continued progress. Two questions. Question one is, can you give us a little bit more color in regards to your trial design and size and potential closest time to readout for your BV program. And then second question is, can you enlighten us what your expectation is for the ovaprene data that's expected in the second half? And is there a little bit of a closer guidance in regards to timeline? Thank you.

Sabrina Martucci Johnson

Sure, yes, thank you, Yasmeen. Great question. This is Sabrina. In terms of that, the BV1 program, in terms of the design of the study and kind of timing and timelines for that, as you may be aware the FDA has addressed guidance documents that they put out in 2016, which is really quite clear in terms of what the basic requirements are for the treatment indication. It's really looking at the resolution of the clinical signs and symptoms of the condition at day 7 to 14. And then ideally following women out to day 21 to 30, for a secondary outcome measure where you look again at that ability to maintain that resolution of the clinical signs and symptoms.

And so from a design perspective, that is really sort of the basic of what's required for that indication. And in terms of structure of this study, the guidance document allows for either placebo controlled or active control comparator, and we've talked about -- our intent is to look at a placebo controlled study. In terms of size, therefore, the estimates are that about 250 women would be sufficient for that.

As I mentioned now, in my comments, one of the things that we are doing right now, and this is part of the reason to really target the fourth quarter this year for the start of that study is we have been seeking input from potential commercial partners that have expressed interest in the program.

This really helps us ensure that we're designing a Phase 2 program that not only meets the minimum FDA requirements, but really aligns with their view of how we can best position BV1 in the marketplace, given the unique characteristics that have been seen to-date in terms of the one-time dosing and the 88% cure rate that's been seen. And so those are some of the things that we're working on. And that's part of the timing.

In terms of the second part of your timeline question on that, we expect, as I mentioned, to start that study in the fourth quarter of this year. That would really indicate a data readout in 2020. And as I mentioned, our intent would be then to file the NDA in 2020 as well.

In terms of the second part of your question, which is really around ovaprene, and the ovaprene data readout, so we have guided second half of the year, we have not provided more clarity on exactly when that is at this point yet. We will do that at the time that we announce completion of enrollment. As we mentioned, trial is ongoing, and is on track to have that data readout then. It's a Post Coital Test study, so it's a very common type of study done with products of this nature, that have an ability to really impede the advancement of sperm into the cervix. That's really how the product is working.

And a Post coital test study allows you to look at that, less than five progressively motile sperm has been determined to be really indicative of contraceptive effectiveness. And therefore the primary endpoint is really to look at the proportion of subjects that achieve that. And those are what you should expect, in terms of the data readout.

Success in that study is really what positions us to then file the IDE, which would allow us then to advance into that pivotal study in 2020, which is a really traditional type of contraceptive effect in this study where you'd actually be looking at pregnancy rates over time. So the PCT state doesn't look at pregnancy rates, it looks at the ability to block progressively motile sperm from getting to the cervix, and therefore having the ability to impregnate. And then the pivotal would actually look at contraceptive rates.

Yasmeen Rahimi

Thank you so much, team.

Sabrina Martucci Johnson

Thank you.

Lisa Walters-Hoffert

Thanks Yasmeen.


Thank you. And our next question comes from the line of Caroline Palomeque with Maxim Group. Your line is now open.

Caroline Palomeque

Good morning. Thanks for taking the question. So I'm wondering if you could talk more about your patient reported outcome end points components, and how they differ from what traditional FDA end points would be, and this is for the Sildenafil Cream program for the Phase 2b trial?

Sabrina Martucci Johnson

Yes, thank you for that. So female sexual arousal disorder, as I mentioned in the opening comments, and just to make sure everyone's clear on what it is, it is a -- it's a physiologic condition. So it really is a lack of an ability to attain or maintain sufficient sexual arousal and the result of that causes inter personal distress. So that's how the condition is diagnosed, that's how it's defined. And so a treatment for arousal disorder is really something that would address that.

In terms and specifically, therefore, really what women are experiencing is an inability to sense a sort of physical sensations, right, of genital arousal. And so as we think about a patient reported outcome, which is really the best way in a clinical trial setting to determine the patient's experience with the product, it's really looking at what types of questions can she answer that help understand that physical response, that general sensation response.

There are a number of validated questionnaires. We refer them sometimes as instruments. In the area of sexual dysfunction in sexual health and many of them have questions specifically around those genital sensations of arousal. And so as we think about this content validity study and developing a new patient reported outcome construct, specifically for FSAD, it's really looking at those already designed and drafted questions. And working with women, which is what we're doing right now to make sure we have a clear understanding of how those questions relate to their most bothersome symptoms, are they capturing that? And do they understand the questions?

And in the end, the goal of the content validity study, and then the follow-up meeting that we're planning to request with the FDA is really to ensure alignment, that we have questions in that patient reported outcome, they're really getting at those genital sensations of arousal that these women are not experiencing, that they understand the questions, and that it's really an endpoint that makes sense, specifically for Sildenafil Cream.

And that's a really important part of the guidance document that the FDA put out in 2016, about arousal disorder is that they're really looking for sponsors to identify a primary endpoint that is appropriate for the condition, but also appropriate for their drug. And therefore given how Sildenafil Cream works, that is really our focus.

Caroline Palomeque

Okay. Great. That's helpful. Then just one more question, how you're viewing the competitive space? And do you see any trends and potential partners, and then is there a certain profile that -- of companies that are interests -- are of interest to you? Thanks.

Sabrina Martucci Johnson

Yes, and sort of are you speaking in general or specifically to the arousal disorder space?

Caroline Palomeque

No, no, in general.

Sabrina Martucci Johnson

Okay, great. Okay. I figured, I just want to check. And yes, as John mentioned that, I'll let him talk a little bit about this too. But as John mentioned, there are a number of players in women's health space, and some have even made greater commitments to the category than they had historically. And so those are the kind of corporate partners that we find very interesting, because our portfolio, across the portfolio really can resonate with these partners. And John, anything you want to add to that?

John Fair

Yes, I would just echo that. I think we've really identified and messaged this on numerous occasions that we believe there's a market misalignment, that there is really great compelling innovation in early stages, and that commercial partners are really looking for later stage assets. So our role as the accelerator is the opportunity to develop those assets and really deliver innovation to those companies.

And the good news is there's a lot of new and emerging companies coming into women's health and really looking to build commercial capabilities. But there's also a number of large strategic partners that are still in the space and still looking for innovation. So we're really excited to be at this point at this stage.

Sabrina Martucci Johnson

Thanks for your great question.

Caroline Palomeque

Thank you.


Thank you. [Operator Instructions] And our next question comes from the line of Brian Marckx with Zacks Investments Research. Your line is now open.

Brian Marckx

Good morning. Sabrina, what is your expectation of what you'll need to support the IND for BV1? And anything in addition to the 30 patient pilot study?

Sabrina Martucci Johnson

Yeah, so great question. And we've said previously that the prior sponsor, basically the licensor of the technology has had communications with the agency and based on those discussions, really it's putting the document together. It's not a matter of literally generating new information per se. It's really compiling the document. And as now having taken over the program, one of the things that it allows us to do is think about long term commercial manufacturing and having an opportunity to work with a long term commercial manufacturer and incorporating that right in the IND as well.

But in terms of any new studies that are anticipated to be required, that's not the expectation based on the prior communication.

Brian Marckx

Okay. And the 2016 FDA draft guidance states that typically, and I'm kind of paraphrasing here, two trials are recommended. And it sounds like you're expecting only one trial. Was that part of the feedback that was gathered from the pre-IND meeting with the FDA?

Sabrina Martucci Johnson

Right. That's a great -- another great question. And yes, we've guided before that basically, based on that prior communication the indication was that just one Phase 3 trial would be required. That's not abnormal by the way for a product like this. Clindamycin is already approved at a 2% formulation for vaginal form for bacterial vaginosis. So this is this is a 505(b)(2) program in a very traditional sense. There's regulations around how product can be reviewed.

So we're administering the same drug that's already approved for the indication, but in a novel delivery technology that the technology itself is why we believe the clinical findings were better than what's been seen historically with this exact same active ingredient. But it is a product that's already been approved. And that's one of the values of the 505(b)(2) regulatory pathway sometimes is that it can have that ability to decrease your time and potential cost to market.

Brian Marckx

Sabrina, were the discussions of the previous owner, BV1, did those take place before or after the 2016 draft guidance was published?

Sabrina Martucci Johnson

Yeah, that's a fair question. And we haven't stated specifically when they took place other than to say we believe that they are very relevant to today's environment.

Brian Marckx

Okay. And then then one last one in terms of the comparator or placebo, you mentioned that you expect to use a placebo in the pivotal study. Is there any implications relative to the label or indications with using the placebo versus using an active control?

Sabrina Martucci Johnson

Another good question. If you look at most of the other studies that have been done in the category they are placebo controlled studies. And so that really is the norm. And as I mentioned in the opening comments, one of the things that we've been doing and taking the opportunity this time to do before we commence the program is really speak with both KOLs and potential commercial partners about the study design.

And certainly the control vehicle is an important part of any of these conversations, both with health care providers in terms of how they expect to use the product and can product it compare the data across other products in the category as well as of course, as I noted, the potential partners that would be looking to take this product to market potentially.

And really across the board, feedback has been that placebo control is adequate. That is the norm. The design of these studies is very consistent again, because there's been the guidance document and frankly, even before the guidance document in terms of how these studies were conducted and run, and what was being evaluated is very consistent. And so unlike some therapeutic categories where trials -- the trial designs can be very different, or end points might be very different across particular treatment regimens is really not the case here and that’s one of the reasons that placebo controlled really is adequate.

Brian Marckx

Okay, all right. Thank you very much.

Sabrina Martucci Johnson

Yeah, absolutely.


Thank you and I am not showing any further questions at this time. I would now like to turn the call back to Sabrina Martucci Johnson, Chief Executive Officer for any further remarks.

Sabrina Martucci Johnson

Great, well thank you. Really just want to thank everyone for taking the time this morning. We absolutely appreciate it and we sincerely look forward to keeping you updated on our progress this year. Thank you.


Ladies and gentlemen, thank you for participating in today’s conference. This does conclude today’s program. You may all disconnect and everyone have a great day.