Daré Bioscience, Inc.
Q1 2021 Earnings Call Transcript

Published: 13 May 2021

[Operator:]

Welcome to the conference call hosted by Daré Bioscience to review the Company’s Financial Results for the Quarter Ended March 31, 2021, and to provide a General Business Update. This call is being recorded. My name is Ryan, and I’ll be your operator today. With us today are Sabrina Martucci Johnson, Daré’s President and Chief Executive Officer; John Fair, Daré’s Chief Strategy Officer; and Lisa Walters-Hoffert, Daré’s Chief Financial Officer. Ms. Johnson, please proceed.

[Sabrina Martucci Johnson:]

Thank you. Good afternoon and welcome to our first quarter 2021 financial results and business update call for Daré Bioscience. Our plan today is to review the last quarter’s results, discuss developments since our last call in March and use the time to highlight objectives and milestones anticipated for 2021.

[John Fair:]

Thank you, Sabrina. With our first NDA submission plan for later this quarter, we are entering an exciting time for DARE-BV1. As noted during our March call, we are advancing our partnership discussions in parallel with DARE-BV1 regulatory developments and believe that we are well positioned to execute a definitive commercialization agreement and to announce our commercialization strategy before the end of this year. We believe that there is broad clinician awareness of bacterial vaginosis, and based on stakeholders, we've spoken to we believe that this category is ready for a new, potentially more effective and more convenient prescription option than what is currently available. It's our belief that a one-time vaginally delivered product with the potential deliver the best clinical cure rates in the category will be a welcomed addition to the bacterial vaginosis diagnosis and treatment plan for the healthcare providers who routinely diagnose and treat the serious and often persistent condition. As we discussed on our last call, DARE-BV1s differentiated product profile gives us a lot of optionality as relates to how we go-to-market and in the interest of doing the right thing by patients and other key stakeholders, we are exploring all options to make sure we identify the most effective way to get the product into the hands of patients, if we have regulatory success. These options reign from a full out license where Daré would likely be eligible to receive milestones and royalty payments, but where Daré has no role in commercialization through to a scenario where Daré plays a more active role in commercialization. And in addition to planning for the go-to market strategy in the U.S., we are actively exploring commercialization options with potential partners outside of the U.S. So we look forward to continuing to keep you apprised of our partnership progress for both the U.S. and ex-U.S. opportunities. And with that, I will turn it over to Lisa for a financial update.

[Lisa Walters-Hoffert:]

Thanks, John. Hey everybody, and thanks for joining our call today. I would now like to summarize Daré's financial results for the quarter ended March 31, 2021. As you know, the Daré's business model is to assemble advance and monetize a portfolio of novel product candidates in women's health. As a result, our expenses consists of corporate overhead, portfolio acquisition and maintenance costs and research and development or R&D activities to advance our candidates through clinical and regulatory milestones, including approval. For the quarter ended March 31, 2021, Daré's general and administrative expenses were approximately $1.9 million. And research and development expenses were approximately $5.7 million. The quarter’s increase in R&D expenses compared to the same period in 2020 primarily reflects increases related in the costs, related to clinical, regulatory affairs and other development activities related to Sildenafil Cream, DARE-BV1, Ovaprene and DARE-HRT1. Our comprehensive loss for the quarter was approximately $7.3 million. During the first quarter of 2021, net cash proceeds from financing activities were approximately $11.4 million and represented net proceeds from sales of common stock under our ATM program, equity line and warrant exercise. We ended the quarter with approximately $7.7 million in cash and cash equivalent. Between April 1 and May 10, Daré received additional net cash proceeds of approximately $2.6 million from sales of our common stock. Following these activities, and as of May 10, 2021, we had approximately 49.4 million shares of common stock outstanding. During the balance of 2021, we will seek to continue to manage our cash resources efficiently and to access capital in a thoughtful manner. And there were two areas, I'd like to highlight. The first is grants. Grants have been an attractive source of non-dilutive funding for Daré, and we recognize grant funding in the statement of operations as a rejection to our R&D expense. We will continue to use our existing grants for allowable expenses and to intend to explore and to apply for additional grant funding. Second is our S3 shelf registration statement. We intend to explore a variety of financing options for our company using our existing S3. In addition to the ATM program that is currently in place with SVB Leerink. Lastly, we will endeavor to be creative and opportunistic in seeking the capital we need to build value to advance our candidates. We encourage investors to review the more detailed discussion of our financials and financial condition, our liquidity and capital resources and our risk factors in our Form 10-Q for the quarter ended March 31, 2021 that we filed today, as well as our annual report on Form 10-K for the year ended December 31, 2020, that was filed on March 30, 2021. I would now like to turn the call over to the operator for Q&A.

[Operator:]

And our first question comes from the line of Zegbeh Jallah from ROTH Capital Partners.

[Zegbeh Jallah:]

Thanks for the update. Can't believe you almost have four clinical programs, really exciting. I think just a few questions. The first one starting with DARE-BV1, just kind of want to have you guys perhaps elaborate on the market opportunity, and how you imagine your drug being positioned I think some of the things you mentioned was, antibiotics being commonly used, this is non-systemic, but I was just wondering if you can just provide some clarity for folks on the line in terms of, how you proceed as the imposition and how big this market is?

[Sabrina Martucci Johnson:]

Yes. That's a great question. Thank you for it. And let me give some perspective on the market and on specifically, really DARE-BV1 and some of the differentiating factors with the product. So as I noted, there are 21 million women in the United States with bacterial vaginosis and about 15% – 15% to 20%, depending on the data that you look at are in the healthcare system and are actively seeking treatment. So those are definitely the immediate target patient population that one would be going after. It's a highly recurrent condition. So 50% of women have recurrent disease and 60% of women have had treated for at least one episode in the last 12 months and so highly recurrent condition and that tends to be very representative of the patients who are seeking treatment. So that's the market landscape today. And as I mentioned that the cure rates for the products that are available today are 37% to 68%. But it's an important notes there, as we mentioned, many clinicians and patients really prefer a vaginal treatment for a vaginal condition. Particularly, when you're dealing with antibiotics and you're dealing with something recurrent, right? You're wanting to avoid systemic exposure to antibiotics whenever possible, right? Just as a medical society and patient group. So vaginal is really preferred. And if you look at the vaginal methods, the cure rates of the currently marketed FDA approved vaginal methods of 37% to 64%, but just 37% to 53% on that intent to treat basis. And that 64% is per protocol. So as you heard our data, they're standalone just right there, standout against the pack, in terms of the cure rates that we saw. So on a modified intent to treat basis, compared to that 37% to 53%, we saw 70% – of the vaginal products, we saw 70% or 76%, if you're looking at the day 7 to 14 and on that per protocol basis, instead of the 64%, we're seeing 77% to 81%. So the product really stands out in terms of the ability to demonstrate a cure. So that's first and foremost, but importantly, it's also super convenient. It's a single administration, it's a clear vaginal gel, and it is very bio-adhesive meaning it really stays in place. And that's why likely we're seeing the cure rate that we do. So in terms of differentiating in the marketplace, those are going to be two important factors. You also saw in the cure rates, how the response rate at day 7 to 14. We were also very excited about just the patient perception in the study. We looked to share more about some of these findings and publications, but it was very well received by the patient population in the study. And they had a really positive response in their electronic diaries to the product as well. So we're really excited about this product is one where providing clinicians with the right opportunities to prescribe it for their patients and patients to try it. We're very optimistic about what they're going to see and experience and very different from the other treatments that are available for them today. And anything I missed team that you want to add to that?

[John Fair:]

I would just add, I mean, if you look at the product profile, this product really solves for a lot of the problems that currently exist for women who are experiencing bacterial vaginosis. We're delivering it in the convenient one-time dose. We have the highest clinical cure rates. The study was done in a heavily pretreated population and still this demonstrates the highest clinical cure rates. When we revealed this kind of a profile to providers as an example, or payers, it really resonates. So we are very excited. We don't want to over guide, but we were very excited about the opportunity.

[Sabrina Martucci Johnson:]

Perfect. And maybe one more question. And then we'll move on.

[Zegbeh Jallah:]

Yes, yes, definitely. I think the other one for me is just about DARE-HRT1 to try to figure out, what we should be looking for in the readout that's coming up shortly.

[Sabrina Martucci Johnson:]

Okay. That’s a great question. Thank you for asking. So indulge me, I'm going to take a step back on the HRT1 program and just share a couple other things about this program, which is why we're so excited about it, which is, it's a 28-day vaginal ring. So it's designed her to leave it in place for 28 days, and it's delivering estradiol and progesterone together, which are the two hormones that if you're administrating hormone therapy, which the North American Menopause Society recommends for women who are suffering from the vasomotor symptoms of menopause and the genitourinary syndrome of menopause as a treatment, because there are a number of benefits of hormone therapy. But they're really recommending a non-oral route whenever possible. And so this product is to our knowledge, the first it's really following those recommendations and administering the product in a way that's convenient for her. So it's vaginal. So one time every 28 days, and it's that non-oral and with both of the hormones together, which is also what they recommend. And hopefully it's one of the lowest effective dose possible of the two hormones. So in terms of what you should expect from the study it's really designed as a Phase 1, it's a PK-study. So we're looking to demonstrate the appropriate levels of the hormones, and we do have comparative products that we're comparing to in the trial, so that we can get a sense of how the PK holds up against those products in the Phase 1. But we did also have some safety and acceptability assessments as well. So as we report the data, you should expect to hear about the PK findings, which is obviously first and foremost important, but also any safety findings in the study and some sense of how the women in this study excepted the technology.

[Zegbeh Jallah:]

Thanks and congrats on the progress.

[Sabrina Martucci Johnson:]

Thank you.

[Operator:]

And the next question, we have come from Doug Tsao from H.C. Wainwright.

[Chris Bialas:]

Hi everyone, Chris Bialas is here on for Doug. I got two quick ones. The first one is about the BV1 NDA. So I'm sure you're aware there's a huge agency backlog on the pre-approval inspections. And how do you think that could potentially affect your NDA approval and does the prior – sorry on the prior review puts you ahead in the queue compared to some of the standard reviews?

[Sabrina Martucci Johnson:]

Yes, really interesting question. So I will say it's been interesting, because we are dealing with the infectious disease division, right at the FDA. This is a serious infectious disease condition. In fact, we have qualified infectious disease product designation, and fast track. And those designations really are designed to help sponsors that are working in an area where there really has been an identified serious unmet need and to make it possible to have more timely interactions with the agency. And that's we're also able to apply as you noted for the priority review. So to date, I can only speak to date, we have found the interactions to absolutely be timely responsive as one would hope. Developing a program like this with the agency, and we haven't felt any sort of implications of the busyness at the agency and specifically the potential busyness of the specific division that we're working with during a global pandemic and with all they're dealing with. So we haven't seen that obviously can't know what's to come, but at least from what we've experienced to date, we haven't felt that to date. And then from a manufacturing perspective, obviously, we're doing everything we need to do to be ready. And as you know, sometimes depending on the manufacturer, they don't always do those inspections, right. They can opt to not deem that necessary for your product. So they do have some optionality as an agency as well in terms of how to approach it for a program like this, given some of the other designations that we have, if it's relevant to do so and if it becomes necessary, for instance.

[Chris Bialas:]

Got you. And then just one quick one about the Ovaprene IDE, you said you're on track for submission for 4Q. What, if any, are the gating events for this submission?

[Sabrina Martucci Johnson:]

Another great question today. So as some of you may remember with Ovaprene, we had originally been looking at filing the IDE last year. And for a number of reasons, primarily obviously, associated with kind of world events, it really created an opportunity for us to take a step back and take advantage of some of the opportunities that are actually a little bit unique with the device division of the FDA, which is where Ovaprene is – it's the lead review division for the Ovaprene, where they provide an opportunity for a sponsor, if a sponsor so chooses to have interactions with the agency in preparation for the IDE. And it's a little bit different than what happens with SEDAR, where you get your kind of pre-IND meeting and you get your one shot. So you're allowed to have a little more interaction with the agency. And so we definitely, took advantage of that process so that we could to your point, do work for the IDE that maybe we wouldn't have otherwise felt was necessary. But may have been relevant down the road or may have been relevant for the PMA or could have even implications on how the pivotal study looks. And so we really use as interactions that have taken the time to do nonclinical and manufacturing related activities to support this submission. And then based on those plans, the submission timing was really related to those activities as well as kind of a mindset on our product, that for a contraceptive study where you have to enroll women who are willing to get pregnant, right? Even though you’re demonstrating hopefully the effectiveness of your contraceptive, you enroll women at risk of pregnancy for a number of factors as well. We felt that was a trial probably best started in 2022. Even though the world is opening up and we’re clearly felt comfortable starting the Sildenafil study this year. And obviously we felt very comfortable last year of running bacterial vaginosis. Contraception’s a little different. So for all of those reasons, everything was timed along those lines. And so the IDE filing is timed based on given the plans then of the work we wanted to do to support the IDE submission and kind of how we could time it given a 2022 start and working backwards from that that’s how we came up to the fourth quarter. So it’s manufacturing, it’s nonclinical activities, it’s writing, it’s all of that leading up to most importantly a 2022 start, which was looking at having some data readout by the end of 2022. So that’s how we got to that timeline.

[Chris Bialas:]

Awesome. Thanks so much for the color.

[Sabrina Martucci Johnson:]

Yeah, absolutely.

[Operator:]

And the next question that we do have on the line comes from line of Shivendu Seneroy from Brookline.

[Unidentified Analyst:]

I am Subhendu calling in for Kumar from Brookline. Thanks for the update. With regards to the Phase 2b RESPOND study of Sildenafil cream for FSAD, assuming the results at the end of 2021 are in line with expectations. Could you please provide some color about your future plans, including plans for commercialization of the product?

[Sabrina Martucci Johnson:]

Yes. Thanks for asking about that program. It’s definitely one that we’re quite enthusiastic about here, given the unmet needs in the category and given that we’re using the same active that’s in Viagra and it’s a PD-5 inhibitor, which should have some utility in this condition. So in terms of next steps, the Phase 2b is really designed to demonstrate efficacy of the product and is also designed to allow us to evaluate a number of different endpoints. So as I mentioned up front, we are the first sponsor moving forward against this indication, I’ve been working with the FDA on this because there are no FDA approved treatments. And so as a result, it’s been a very collaborative process with the FDA around designing a Phase 2b that allows us to have obviously the pre-declared – the declared primary endpoint, but also a number of secondary and exploratory endpoints so that these data can really become the basis for planning the Phase 3 program and going forward from there. So this study is a 12 week study. The FDA guidance documents give some guidance on what’s required for female sexual arousal disorder in Phase 3. But this study itself is going to be very much providing a lens for us of what to take forward into Phase 3. In terms of endpoint could be the same, could be one of the exploratory that we take forward into Phase 3. And then we’ll also provide some input into duration of study. So the guidance document currently says 24 weeks for Phase 3. But we’ll have some nice insights into 12 week study and how that looks for this indication, which is different from some of the other female sexual dysfunction indications that have been studied previously, which are more psychological and need more time. So in terms of then what comes next is there’s the Phase 3 program to run. And then from a commercialization perspective, assuming positive outcome on the Phase 2, we expect to have a lot of optionality with this program in terms of partnering opportunities, decisions that we can make on whether we involve a strategic partner in the development, whether we involve a strategic partner in commercialization, whether we take it forward on our own. And frankly, that’s a nice point for me to make about the portfolio in general. What’s really interesting about our portfolio, we think as a company and having built such a diverse portfolio with so many independent outcomes, different programs for different indications at different stages of development, it really gives us a lot of optionality. We’ve really structured a portfolio that allows us as a company Daré with our stakeholders – our shareholders, to decide what is the best way to create value and we can do that on a program basis and on an aggregate basis. Is it to partner? Is it to go alone? Is it to co-develop? Is it to develop on our own? And that’s really the lens that we’ve been using as we’ve looked at the Ovaprene partnership, as we’re looking at BV1. And absolutely, as we hopefully get to a successful Sildenafil Phase 2b, that’s exactly how we’ll be looking at that program given what’s coming behind as well. So definitely more to follow on that, but thank you for the question.

[Unidentified Analyst:]

That’s very helpful. Thank you so much. Just one more question, I’m just curious of the advantages of organizing our VVA trial in Australia as compared to U.S.

[Sabrina Martucci Johnson:]

Yes. So thanks for asking that as well. So Australia provides some really interesting opportunities that we just touched on briefly in this call, but we’ve mentioned in some other calls, which is you can proceed with the clinical trial in Australia with programs like ours. As you know, we leverage that 505(b)(2) regulatory pathway pretty heavily across our portfolio, which means we are dealing with well understood, well-known actives. We’re just applying them either in novel dosage forms or novel indications to create these first in category opportunities. But what that means, if you’re going to run a clinical program in Australia, it means you can actually run a human clinical program without the equivalent of the time and paperwork and often additional nonclinical studies that are required for an IND submission in the U.S. So it allows you to actually run things in parallel, get that human data in parallel or before you’re doing some of the other work that would be needed for an IND submission. And that human study actually becomes part of your IND and supportive of your IND submission, which can also mean that you’re then expediting, advancing the program in the United States into Phase 2. Therefore, so it offers a lot of advantages from that perspective, just from a time perspective. But it also offers cost advantages. We have a subsidiary in Australia and I’ll let Lisa chat right now a little bit, just to give you a sense of the kind of rebate structure, cash rebates that we get from having that subsidiary in Australia when we do research there.

[Lisa Walters-Hoffert:]

Yes. And just echoing what Sabrina said, the cash advantages of Australia, first of all, the expenses in general are a little bit lower for conducting a clinical study. But the government has an R&D tax incentive program in place for certain programs and certain activities. So we have to track, but we at the end of the year can apply for basically a refund on a portion of the expenses that we – expense during the course of a year. And it can be up to 43.5% that’s the current kind of maximum rebate. So as Sabrina said, the ability to start the trial a little earlier, because some of the regulatory issues and then also the cash cost of that being a little bit lower, it really makes a lot of sense to do some of our earlier studies there, if we can.

[Sabrina Martucci Johnson:]

Yes. So you’ll see that whenever it makes sense. It is our strategy to run the Phase 1’s whenever we can in Australia. Now with FRT1, we have the nice grant potential from the NIH up to $2.3 million to fund the Phase 1 in the U.S. So when we get non-dilutive funding like that, and it’s paid for, we absolutely will do that in the U.S. as required under those grants. But otherwise, Australia is a really attractive option for us.

[Unidentified Analyst:]

Sounds great. Thank you so much for taking my questions.

[Sabrina Martucci Johnson:]

Thank you.

[Operator:]

And at this time there are no other questions. Thank you. So I would like to turn it back to Sabrina.

[Sabrina Martucci Johnson:]

Great. Well, thank you. And thank you all for taking the time this afternoon to hear about the recent updates and our strategies to improve options and health outcomes for women and our ongoing commitment to drive value for all of our Daré’s stakeholders. So in closing, 2021 as your hearing, is a year with a number of potential meaningful developments for Daré. All independent of each other across the portfolio and I’d like to take a moment to summarize them. So with DARE-BV1, so we’re – which is a bacterial vaginosis program, we’re intending to submit that NDA, enter into and announced this strategic commercialization agreement, and hopefully have a PDUFA goal date, which could result in an FDA approval by year end. With our sexual health programs, Sildenafil cream, for female sexual arousal disorder. As we were just talking about our Phase 2b clinical study is ongoing, and we are hopeful of having top-line data by year end. With Ovaprene also as we discussed, we’re going to be filing – our intent is to file that IDE in the fourth quarter to enable a pivotal study start in 2022, as we discussed. And then as we were talking about with our menopause program, DARE-HRT1, that Phase 1 clinical study top-line data readout is expected this quarter. So keep an eye out for that. And then as we were just discussing, we are very much looking forward to starting that Phase 1 clinical study with DARE-VVA1 program for women seeking a non-hormonal approach to vaginal atrophy, including women with hormone receptor positive breast cancer. So watch for that as well this year. And we look forward to keeping you updated on our progress against these important 2021 objectives throughout the year. Thank you again for your time today.

[Operator:]

And this does conclude today’s call. You may now disconnect.