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spk07: Thank you all for standing by, and welcome to the conference call hosted by Dare Bioscience to review the company's financial results for the quarter ended June 30, 2021, and to provide a general business update. Please note that this call is being recorded. This is Jesse, and I'll be your operator today. With us today are Sabrina Martucci-Johnson, Dare's President and Chief Executive Officer, John Fair, Dare's Chief Strategy Officer, and Lisa Walters-Hofford, DARI's Chief Financial Officer. Ms. Johnson, please proceed.
spk04: Thank you. Good afternoon and welcome to our second quarter 2021 financial results and business update call for DARI Bioscience. Our plan today is to review last quarter's results, discuss developments since our last call in May, and use the time to highlight objectives and milestones anticipated for the balance of 2021. Before I 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 fact should be considered forward-looking statements. Actual results or events to differ materially from those anticipated are implied by these statements due to known and unknown risks and uncertainties. You should not place any reliance on forward-looking statements. Board-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter-ended June 30, 2021, which is filed today, as well as our annual report on Form 10-K for the year-ended December 31, 2020, filed on March 30, 2021. I would also like to point out that the content of today's call includes time-sensitive information that is current only after today, August 12, 2021. DARI undertakes no obligation to update forward-looking statements to reflect new information or developments after this call, except as required by law. DARI is a leader in women's health innovation, and we are squarely focused on improving the lives and well-being of women. Our value creation strategy is to accelerate availability of new prescription products for women by selecting and advancing product candidates that we believe have the potential to be first in category and first line and have meaningful commercial opportunities. We currently have four clinical stage programs in the areas of vaginal health, sexual health, contraception, and menopause, and one product in the breast cancer supportive care category soon to enter phase one. And most of my remarks today will address these candidates. The first half of 2021 has been quite eventful for DARE. And the announcements we were able to make over the last two months have been the type of updates that every CEO enjoys making. We announced positive Phase I data for our hormone therapy products, an up to $48.9 million grant over the course of five years for one of our preclinical contraceptive programs, a collaborative research agreement with the NIH to co-financially support and co-conduct our Phase III study for investigational contraceptive otoprene, And just this week, we announced the FDA's acceptance and priority review of our NDA for our bacterial vaginosis product candidate, with a December 7, 2021, producer target action date. It has definitely been a meaningful few months for DARI, and we hope it will continue to prove to be a meaningful year for us, given what we have yet to come. With that backdrop, I'll now provide some additional context on those accomplishments and specifically dive deeper on the relevant updates related to our four clinical stage programs, as well as that supportive care cancer program. In the vaginal health category of bacterial vaginosis, which impacts an estimated 21 million women in the United States, I'll start with DARE BV1. During the second quarter of 2021, and in line with our guidance, we submitted a new drug application, or NDA, to the FDA. We requested a priority review at that time of submission. We announced that the FDA accepted for filing the NDA for DRV-1 for the treatment of actuarial vaginosis, and the FDA granted this application priority review and set a Prescription Drug User Fee Act, or PDSA, date of December 7, 2021 for the target completion of its review of the NDA. The FDA grants priority review to applications for potential drugs that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment of a serious condition. The NDA we filed is supported by positive results from the DARE BV3 Phase III randomized, multi-center, double-blinded, placebo-controlled clinical trial evaluating DARE BV1 in women diagnosed with bacterial vaginosis, a condition that can cause serious health effects and risk and is very disruptive in terms of the symptoms. And as I mentioned, it's estimated to affect approximately 21 million women in the United States. DER-BB-1 is an investigational thermosetting bioadhesive hydrogel containing chondomycin phosphate 2% that's designed as a one-time vaginally administered treatment for bacterial vaginances. The acceptance of this NDA marks a major milestone, not only for Daria as a company, but importantly for the millions of women that are impacted by bacterial vaginosis. It is our goal as a company to bring to market products and products like this that have the potential to improve outcomes and convenience for women. As DARE-BV1 demonstrated, it has the potential to do in the phase three study. where a single vaginal dose of DARE BV1 achieved clinical cure rates in the range of 70 to 81%. Specifically, the results from the DARE BV3 study demonstrated DARE BV1's potential to improve clinical cure rates in a convenient one-time dose compared to those of currently FDA-approved branded products indicated for the treatment of bacterial vaginosis. Patients in the study were evaluated during three clinic visits. Day 1, which is screening and randomization, Day 7 to 14, which is an interim assessment visit, and Day 21 to 30, which was the test of cure visit. This study met its primary endpoint, demonstrating that as a primary therapeutic intervention, a single vaginal dose of DRBB1 was statistically superior to placebo at that Day 21 to 30 assessment in the modified intent-to-treat population, specifically 70% compared to 36% of subjects clinically cured. Additionally, DARE BV1 demonstrated clinical cure rates of 77% at days 21 to 30 and 81% at days 7 to 14 in the per-protocol population, compared to 43% and 30% for placebo clean, respectively. Current FDA-approved products have clinical cure rates in the range of only 37% to 68%. DARE BV1 has received both Qualified Infectious Disease Product, or QIDP, as well as fast-track designations from the FDA for the treatment of bacterial vaginosis. Under the QIDP designation, if approved, we expect DRVV1 will receive five years of market exclusivity in addition to the three years available for having generated new clinical data. Ongoing strategic discussions and other activities to support a robust market launch of DRVV1 in 2022, if approved, are underway and we plan to finalize and announce the commercialization strategy for JRBV1 in the U.S. by year-end. John will be providing additional color in a moment. In the sexual health category, I'll now provide an update on Sedentifocrene 3.6%, our investigational product to address her version of erectile dysfunction. In March of this year, we commenced our Phase IIb clinical study evaluating Sedentifocrene an investigational cream formulation of sidenafil, the active ingredient in Viagra, for topical administration to treat female sexual arousal disorder, or FSAD. FSAD is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal during sexual activity. And of the various types of female sexual dysfunction disorders, it is most analogous to erectile dysfunction in men. FSAD represents a large unmet need, with an estimated 10 million women in the U.S. experiencing distress from symptoms of low or no sexual arousal and actively seeking treatment. No FDA-approved products exist today to treat FSAD, despite the fact that the FSAD market is estimated to be as significant, if not more so, as the erectile dysfunction market in both the U.S. and the rest of the world. If our clinical development is successful, Sudentico Cream has the potential to be the first FDA-approved FSAV treatment option. We are actively enrolling subjects into the Phase IIb Respond clinical study, evaluating Sudentico Cream as a potential treatment for FSAV at sites located across the country. During our last call, we said we would continue to provide updates on the progress of the Phase IIb Respond study and the potential impact of COVID-19 are unexpected timelines. We are monitoring this closely and particularly given the evolving COVID-19 guidance and case loads across the country, we feel it's challenging to confirm anticipated timing for the top line data readout until we complete the planned interim analysis to determine the ultimate size of the study. We've recently seen the pace of enrollment at certain sites decline because of those sites being in locations where the caseloads are higher and adhering to government guidelines recommending reductions or changes in their operations intended to reduce the spread of COVID-19. Due to the impact potentially on the pace of enrollment overall for the trial resulting from governmental recommendations or orders intending to reduce the spread of COVID-19 or from other effects related to COVID-19, We cannot predict with reasonable certainty at this time when the interim analysis will be conducted or when we'll report top line data from the trial. As we have done to date, we will continue to provide updates as the trial continues and we can better project timelines. Now, I'd like to provide an update on our investigational product, Ova3, a potential first in category option in the over $7 billion U.S. contraceptive category. Last month, we announced that we entered into a cooperative research and development agreement, which is also known as a CRADA, with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, NICHD for short, which is part of the National Institute of Health, or NIH. This is for the pivotal phase three study of oviprene. The CRADA will allow us to leverage the tremendous development expertise of the NIH in contraceptive clinical studies and to share the cost of the pivotal phase three study. Oviprene is our novel hormone-free monthly contraceptive candidate whose U.S. commercial rights are under a license agreement with Bayer. The next stage of clinical development for Oviprene is this pivotal phase three contraceptive study that we will be conducting under the creator with the NICHD. Grant funding was previously provided by NICHD, and it supported the conduct of our pre-pivotal clinical study of oviprene. The current agreement reflects the NICHD's continued support for the development of oviprene and will allow us to leverage the contraceptive clinical trial expertise of NICHD while also sharing this cause for the Phase III study with NICHD. Specifically, the study will be supported by NICHD's Contraceptive Development Program, or CDP. The CDP oversees the Contraceptive Clinical Trial Network, or CCTN, which was established in 1996 to conduct studies of investigational contraceptives. And the study will be conducted with the CCTN with this NICHD contractor health decision. DARE will be responsible for providing the clinical supplies of oviprene and coordinating interactions with and preparing and submitting supportive regulatory documentation to the FDA. DARE and NICHD will each provide medical oversight for the trial and final data review and analysis and will work together to prepare the final reports and trial results. Under the CRADA, we, DARE, have agreed to contribute $5.5 million towards the total estimated cost to conduct the Pivotal Phase III study, and the NICHD will be responsible for the remaining costs related to the conduct of the study. And they will manage the payment of expenses to help decisions, the clinical trial sites, and the other parties involved with the study. Lisa will discuss this arrangement in more detail shortly. As I mentioned earlier, the U.S. commercial rights program are under a license agreement with Bayer. Bayer and Dari entered into this exclusive license agreement for the commercial rights to Oviprene in January 2020. Under the agreement, we received access to Bayer's extensive clinical and market expertise through up to approximately 80 hours per week in advisory support, and we maintained control over Oviprene's development and regulatory approval process. Bayer has the right to obtain exclusive rights to commercialize the product in the U.S. following the completion of the pivotal clinical trial being undertaken by us with the NACHD. If Bayer, in its sole discretion, makes the payment to DARI of $20 million, which we intend to apply to reimbursement of our portion of the clinical study and manufacturing cost of the program. And at that point, the exclusive license to commercialize oviprene in the U.S. will become effective. We will also be entitled to receive commercial milestone payments, potentially totaling $310 million, in addition to double-digit tiered royalties on net sales. In order to initiate this pivotal Phase III study, we must have an FDA-cleared investigational device exemption, or IDE, in place. We currently plan to file an IDE for oviprene in the fourth quarter of this year, and then pending the FDA's review and clearance of the IDE, we intend to initiate that pivotal phase study in 2022. Next, for the estimated 45 million women in the U.S. who are approaching or in menopause, let's talk about our investigational hormone therapy product, DARE HRT1. So during the second quarter and in line with our guidance, we reported the positive top line data from our phase one clinical study of DRHRT1, which we conducted in Australia. We believe this unique intravaginal ring platform technology offers a versatile drug delivery system in women's health with the potential to deliver different active drugs at different rates and thereby improving convenience and outcomes potentially across multiple indications. The IVR drug delivery technology was originally developed by Dr. Robert Meiner from MIT and Dr. Lynn Crowley from the Massachusetts General Hospital and Harvard Medical School. And this first application of this versatile technology that's being clinically tested is the state DARE HRT1 use of it, which is an investigational 28-day intravaginal delivery of hormone therapy via the ring. And the ring contains both, in this case, bioidentical estradiol and bioidentical progesterone for the treatment of the vasomotor symptoms and the genitourinary symptoms and syndrome associated with menopause. On June 28th, we announced the positive top-line results from our Phase I clinical study of DRHRT1 Australia. That randomized, open-label, three-arm parallel group Phase I study was designed to evaluate the pharmacokinetics of DRHRT1 in approximately 30 healthy postmenopausal women with intact uterine. The primary objective of the study was to describe these pharmacokinetic or PK parameters of two different dose combinations over 28 days. Secondary objectives of the study were to assess the safety and tolerability of DHRT1 and to compare the systemic exposure of the estradiol, which importantly is the active form of the therapeutic hormone therapeutic hormone replacement purposes as well as estrone and progesterone from their HRT1 over 28 days and compare those against a combination of FDA approved oral estrogen and oral progesterone products evaluated in that same phase one study. The levels of estradiol released from both the lower and higher dose formulation in their HRT1 evaluated in the study achieved or exceeded the levels that were targeted for hormone therapy. Target levels of estradiol for hormone therapy for either the vasomotor symptoms or the vaginal symptoms of menopause were established by reviewing PK levels that have been published for FDA-approved products for most of the treatment of EMS as well as the genitourinary symptoms of menopause. And based on the estradiol PK data in DARE-HRT1 in the Phase 1 study, the results support the potential of DARE-HRT1 as an effective hormone therapy for both vasomotor symptoms and vaginal symptoms associated with menopause. The levels of progesterone importantly released from both versions of DARE HRT1 evaluation study also met the objectives of releasing progesterone. And specifically, progesterone is used in hormone therapy to reduce the impact of estrogen on non-target sites, such as the endometrium, and to prevent estrogen-induced endometrial hyperplasia. In addition, the treatment was well tolerated with the most common of adverse events consisting of vaginal systems that are consistent with other vaginal products. DER-HRT1 also had a high level of accessibility in the study with over 80% of subjects on either the low or high dose versions of HRT1 product reporting the IVR as comfortable or very comfortable. And additionally, over 80% of the subjects in each dose group stated that they were either somewhat or very likely to use the IVR for a women's health condition or disease if she needed it. For some women, hormone therapy is a highly effective treatment for the symptoms associated with menopause, like the hot flashes and the vaginal dryness, and it may also prevent bone loss and fracture. The delivery of hormone therapy over 28 consecutive days with no daily intervention supports DARE HRT1's potential to be a first-in-category option, offering ease of use and continuing dosing to women suffering from menopausal symptoms. There are currently no FDA-approved products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple consecutive weeks. We plan on submitting that data from that Phase I clinical study for publication in a peer-reviewed journal. And our clinical development strategy is to leverage the existing safety and efficacy data on the active ingredients in DRHRT1, the estradiol and the progesterone, and to utilize the FDA's 505 pathway in order to obtain marketing approval of DRHRT1 in the U.S. We are in the process of updating our regulatory and clinical development strategy given these positive Phase I data. and will provide guidance on the next step with this program as soon as possible. And finally, before I turn it over to John and Lisa, I want to talk about the approximately 3.8 million women in the U.S. who have a history of breast cancer. Hormone receptor positive, of those women, hormone receptor positive is the most common type of breast cancer. And the prevalence of vulvar and vaginal atrophy, or VVA, in postmenopausal breast cancer survivors is estimated to be 42 to 70 percent. We would like to provide a supportive care option for those women, DARE VBA-1. So as I mentioned in my opening remarks, we plan on initiating a phase one clinical study later this year in Australia for this breast cancer supportive care program, DARE VBA-1. Your VBA-1 is our proprietary investigational formulation of tamoxifen for vaginal administration to treat vaginal atrophy. As a non-hormonal approach to addressing vaginal atrophy, it can be an important option for the women with a history of or at risk for hormone receptor-positive breast cancer. VBA is often the outcome of affected breast cancer treatments, and one of the unpleasant side effects of VBA is painful intercourse. For many women, an appropriate treatment for BVA is supplemental estrogen. However, estrogen may pose a risk to the women at risk for hormone receptor-positive breast cancer, and hence, DARE BVA-1 may offer a solution for these women and others for whom hormonal treatment is not an option. We plan to commence that Phase I clinical study in the second half of this year in Australia and look forward to providing updates on the progress of that program. I'll now turn it over to John to provide a business and corporate partnership update on our two latest stage programs, specifically DARE BV1 and Evaprene.
spk06: Thank you, Sabrina. Now that the NDA for DARE BV1 has been accepted for filing by the FDA and priority review has been granted, we anticipate acceleration across the three main commercialization strategies we've been progressing in parallel, given that the DARE BV1 partnering process has been strategically and purposefully aligned with the DARA BV1 regulatory process. Those scenarios include a straight-out license to a strategic partner where the partner is solely responsible for commercialization in exchange for milestone and royalty payments to DARA based on the revenue generated by the product, a second scenario where we strategically partner DARA BV1 but retain the option to have a role in the commercialization of the product, and finally, a scenario where we can play a direct and active role in commercialization that includes influencing the go-to-market and planning strategy, including the market introduction, through a strategic partnership with a full-service contract sales organization. All three options are currently under discussion. Principally, and in the context of DARA VV1, and really across all of our product candidates, we are focused on doing what's best for women, which is to ensure that these products have broad commercial access And that benefits all of our stakeholders, specifically our investors. We will use this lens to help guide us through our process and to solidify the best strategic opportunity for the introduction of DARE BV1, if approved. As many of you know, women diagnosed with bacterial vaginosis are challenged, often routinely, to find interventions that can rapidly address the signs and symptoms of the infection and also address and resolve the underlying infection itself. currently available FDA approved treatment options work about half the time on average. It's our belief that DERA BV1's product profile will appeal to both patients and providers as it has the potential to provide a clinically meaningful improvement over currently approved FDA products, particularly in terms of a better opportunity for a clinical cure, which includes resolutions of the signs and the symptoms of the infection. And in parallel with our strategic partnering discussions for DERA BV1, We are actively executing other commercial introduction work streams, such as manufacturing and market access, with the goal of allowing us and our strategic partner to execute against a robust 2022 launch should we receive FDA approval in December of this year. In summary, we are encouraged with the progress of the DARE BV1 program, and we are excited at the prospect of bringing this important new therapeutic option to women and providers And we believe that we are well positioned to communicate our definitive commercialization strategy before the end of this year. So I'd also like to take a moment to highlight the ongoing partnership with Bayer for our hormone-free monthly contraception product candidate, Overprime. We are delighted to report that the partnership is progressing as well, if not better, than we could have expected. Bayer, as part of their commitment to provide up to two full-time equivalents in an advisory capacity to support the development stage of the program, has been actively supporting DARE across all of the key functional areas, including CMC, regulatory, as well as strategic planning to inform downstream commercialization to optimize the introduction of this exciting new product candidate if it's approved. As I'm sure many of you know, Bayer is a worldwide leader in the conscious effort category, and that was one of the key drivers behind our decision to partner Overprime at this stage of clinical development. We believe that our Overprime partnership with Bayer is a clear example of our commitment to doing what is best for our stakeholders, our shareholders, and for women, which is core to our strategy here at DARE. So we look forward to keeping you updated on the BEAR partnership as well as other key strategic initiatives here at DARE. And with that, I will now turn the call over to Lisa to give you a financial update.
spk01: Thanks, John. Hey, everyone. Thanks for joining us today. I would now like to summarize DARE's financial results for the quarter ended June 30th, 2021. DARI's business model is to assemble, advance, and monetize a portfolio of novel product candidates in women's health. As a result, our expenses consist 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 June 30th, 2021, DARE's general and administrative expenses were approximately $1.8 million, and our R&D expenses were approximately $7.3 million. The quarter's increase in R&D expenses compared to the same period in 2020 primarily reflects increased costs of clinical, regulatory affairs, and other development activities related to sildenafil cream, DARE-BV1, oviprene, and DARE-HRT1. Our comprehensive loss for the quarter was approximately $9.2 million. During the six months ended June 30, 2021, net cash proceeds raised from financing activities were approximately $24.6 million and reflected sales of common stock under our ATM program, equity line, and warrant exercises. We ended the quarter with approximately $9.1 million in cash and cash equivalents. Subsequent to the quarter's end, between July 1st and August 10th, 2021, DARE received additional net cash proceeds of approximately $25.4 million from sales of common stock under our ATM program. In addition, in July, we received an initial cash payment of approximately $11.4 million in non-dilutive grant funding to support the development of DARE LARC-1. The entire grant award is for up to $48.9 million, with future payments contingent upon the DARA LARC-1 program achieving specified development and reporting milestones. As of August 10th, 2021, we had approximately 70.5 million shares of common stock outstanding. I'd like to take a few moments to highlight a few other arrangements that we expect will favorably impact our cash burn going forward. So first, recall that under Australia's current Research and Development Tax Incentive Program, eligible companies conducting R&D activities in Australia may file for and receive up to 43.5% of their eligible expenses as a cash payment in the following year. We completed our DARE-HRT Phase 1 study in Q2 and intend to initiate our DARE-VVA Phase 1 study in 2021. both conducted through our Australia subsidiary. During the first half of this year in 2021, we received a cash payment of $250,000, and that is in US dollar value, in connection with DARE HRT-1 study expenses that we incurred last year in 2020. We intend to apply for the maximum amount eligible for reimbursement under the program in early 2022 based on allowable R&D expenses related to DARE HRT-1 and DARE VBA-1 incurred this year in 2021. Second, as Sabrina discussed a bit earlier, in July, we announced a Cooperative Research and Development Agreement, or ACREDA, with the NICHD for the pivotal phase three study of oviprene. The agreement will allow DARE to leverage the tremendous contraceptive clinical trial expertise of the NICHD while also sharing the costs of the phase three pivotal study. Under the CRADA, DARE has agreed to contribute $5.5 million between July 2021 and April 1, 2023 toward the total estimated cost to conduct the Pivotal Phase III study. The NICHD will be responsible for the other costs related to the conduct of the Pivotal study and will manage the payment of expenses to third parties. We believe the NICHD's contraceptive trial experience and financial support will allow for the completion of the oviprene pivotal Phase III study in an efficient and cost-effective manner. Third, grants have been a very attractive source of non-dilutive funding for DARE, and we will continue to use our existing grants for allowable expenses and to explore and apply for additional grant funding in the future. In closing, we will endeavor to be creative, collaborative, and opportunistic in seeking the capital necessary to advance our candidates and build shareholder value. We encourage all investors to review the more detailed discussion of our financials and financial conditions, our liquidity and capital resources, and our risk factors in our Form 10-Q for the quarter ended June 30th, 2021, which was filed today, as well as our annual report, on Form 10-K for the year ended December 31st, 2020 that was filed on March 30th of 2021. I would now like to turn the call back over to Jesse, our operator.
spk07: Thank you, speakers. Participants, we will now begin the question and answer session. To ask a question over the phone, you may press the star key followed by the number one. To withdraw your request, you may press the pound key. Again, that's star 1 to ask a question or the pound key to withdraw your request. First question is from the line of Zeghbi Jala of Roth Capital Partners. Your line is now open.
spk03: Hi, thanks for taking my question. Just have a few here. I think the first is for Diary BV1. So congrats on the Biduva date that's happening before the end of the year. We're just kind of curious if the approval process is going to include an inspection of your manufacturing facility. And then we're also just curious as to who's doing the manufacturing of the product.
spk04: Hi, thanks for the question. Yeah, so in terms of whether, you know, it'll include an inspection, you know, those are done at the discretion of the FDA. Often there are pre-approval inspections. They're not always held. So at this time, you know, given that we just received the NDA acceptance to file, I'm not really in a position to answer that question, but definitely would be happy to keep people updated over time. And then we have not disclosed the manufacture of this product other than to say it's a third-party contract manufacturer that we use that is really an expert in the manufacturing of vaginal creams and gels. That's what they do for business. And they have, you know, this is not their first time through a process like this, so they were very well-versed in commercialization and FDA potential inspections.
spk03: Thanks, Sabrina. And then John also mentioned some manufacturing efforts and market assets efforts. Can you elaborate on that, if possible, for DARA BV1 and how you are thinking about that also in terms of, I suppose, helping with the partnership that's upcoming or giving you more leverage, I suppose?
spk04: Yeah, definitely. So, as John noted, you know, we very purposely have been managing our commercial addition strategy partnership process in parallel with the regulatory process, which really puts us in a nice strategic position that we are, you know, kind of fortunate to be able to do with a product like this, given the understanding of the indication and and also the work that we can be doing in parallel to ensure that no matter which approach we then strategically take, the product is well set up to be successful. And so on the manufacturing front, you know, that really means continuing to work with our third party, which is very easy for us to do because they are a third-party manufacturer, and therefore it's very easy to get things ready and then, you know, hand that off to someone if that makes sense. And so that includes all of the work that we would need to basically have the commercial supplies ready to support any sort of regulatory process, inspection process at the manufacturer, and the scaling and everything that's needed to ensure that commercial supply is ready when we are ready to launch the product and and have labeling and all that good stuff. So there's all that work obviously ongoing with our manufacturer. And then work that happens behind the scenes to support that, right, to support a market introduction in terms of sterilization and things like that that need to happen. So all of that is going on on the commercial side in terms of manufacturing. And then on the market access side, which we all know is such an important factor in consideration, there's work that frankly no matter what path we take to launching this product is going to serve the product well to have in place. And maybe, John, if I can turn it over to you to just say a couple words about the landscape analysis, market access, some of that work that we're doing to prepare for that.
spk06: Yeah, sure. And thanks for the question. So, yeah, we really, really view this as fundamental to the strategic launch of the asset, whether that's, you know, any of the scenarios that we've outlined during the call. So, you know, we want to be prepared to understand the patient journey. We want to be prepared to understand the market access levers we're going to need to pull, you know, when the product makes it to market, whether that's in context or in conjunction with a partner. And we also want to understand the landscape that we're going into. Now, the good news is a lot of this is already well known and well understood. I mean, that's the The beauty of bacterial vaginosis is it's a very well-known, very well-understood therapeutic category. So for us, it's really finding that way to differentiate the product in context of the segment we're talking to. So whether that's a payer, whether that's a provider, whether that's a patient. And that's really what this work is going to support moving forward.
spk03: Thanks, Sean. And then just another follow-up there. I think the third scenario you mentioned for commercialization is was perhaps influencing the market strategy. And so I was just wondering if you were to, you know, kind of have your own sales team, how long do you think that could take to, you know, get the product out there? Meaning how do you think it will impact the product launch or the timing of the launch? And then how many sales folks do you think you're going to need to have on board for this product?
spk04: Yeah, so maybe I'll answer this on a high-level basis. And then we should probably wrap up your questions, which have been great, so that someone else can get in. But in terms of a high level, let me just say a couple words about this. So in terms of timing of launch, really we've been managing this process. So whichever one of these potential paths we choose in the end, the timing really would be the same in terms of the launch timing. So part of what we've been wanting and hoping we're communicating clearly is that because of the nature of this product and the nature of the therapeutic category, we have the luxury of being able to time the product process for strategic commercialization in parallel with the regulatory process and not negatively impact the launch timing. So nicely, whichever way we go, the timeline is really the same. In terms of what would be required to launch, I also wanted to make sure one thing is clear, which is, you know, as we think about the launch of this product, and frankly this pertains to nearly every program in our portfolio, it's the same call point, meaning we're talking about the same universe of nurse practitioners and clinicians, physicians, that manage these indications. And in some cases, some might be a little bit higher decile than others, depending on the indication, but it's really the same call universe. And so it also, you know, that's one of the reasons that we have the flexibility of thinking about strategically what might make sense in terms of inactive participation by DARE in the BV1 commercialization, because we have a whole portfolio of other women's health products behind BV1, which have that same call point. And we believe that there are ways that if we were electing to move forward with the strategic partnership scenario with the contract sales organization, that there would be a way to do this responsibly, financially, and economically, and strategically. And so beyond that, that's really at this point all I'm prepared to say in terms of the strategy until we have more to reveal specifically. I'd like to be able to get specific. But hopefully that gives you a little bit of context of how we're thinking about it, how we're thinking about the market, how we're thinking about the launch. And importantly, that, you know, we're moving a process forward in a way that we believe is best for the product, best for DARE, best for our shareholders. And that includes in a manner that doesn't, you know, delay a launch or negatively impact a launch timing.
spk03: Thanks, Sabrina.
spk07: Next question is from the line of Doug Tao of HC Wainwright. Your line is now open.
spk03: Hello?
spk07: Again, Doug Tao of HC Wainwright. Your line is open.
spk02: Hi. Can everyone hear me?
spk04: Yes, yes.
spk02: Yeah. Hey, everyone. Chris Bialis here on for Doug Sao. So congrats on the quarter, particularly on the NDA acceptance. So we just have two questions. The first is, can you give us some more detail on how the overprint IDE process is going? And, you know, aside from the cost savings, what do you see as the main benefit of the collaborative research and development agreement? And how do you think it's going to impact the study? And then I have one more after that.
spk04: Great. Great question, and thanks for asking about that oviprene arrangement. So I'll start first with the IDE. You know, we're progressing with those activities to file the IDE. It really is a matter of pulling together the non-clinical and manufacturing-related information. We've shared before that we really do you know, evidential silver lining of the COVID time, particularly, you know, last year to take advantage of opportunities to have interactions with the FDA as we're planning the evergreen program. And so the IDE filing is really a culmination of those discussions and the work that came out of it. So that's underway. And as we mentioned, we're planning to get that filed in the fourth quarter of this year. And along those lines, you know, we have been obviously speaking with the NIH and NICHD specifically for some time about oviprene. As I mentioned in my opening remarks, they funded through a grant the pre-pivotal study that frankly led to our partnership with Bayer on this program. And so they've been involved with oviprene from a DARE perspective from our clinical work from day one on the program. had been very, you know, helpful throughout that process. And so when the opportunity arose, when it was clear that there was an interest on their part to continue that collaboration into the pivotal study, it was clearly a really positive outcome for the program. And I'll tell you specifically why, and it really falls into three categories. So one, obviously, we talked about is the financial support. You know, we embrace non-relative funding strategically for our programs and clearly did so in this case as well. It's a great opportunity to offset some of our costs, and particularly in light of the financial arrangement then that we have with Bayer downstream. So, and our ability to maintain control over the clinical trial. So, that's obviously positive, but the other two reasons that the collaboration is so positive have to do with first kind of planning for success and then executing for success. So planning for success is really the work that we're working with them now. You asked about the IDE filing, and part of that IDE submission that goes in is, of course, the Pivotal Study Protocol. And being able to work with the NIH on the actual protocol design, along with Bayer, we have now just significantly increase the NAN power and women power on designing that phase three trial and really thinking about, from the VAER perspective, all of the things that we're going to want to have from a commercial lens, right, to make sure the brand has the robust opportunity it deserves. But from the NIH perspective, because their clinical trials network has had so much experience running clinical trials across a variety of different types of studies and types of products, they're bringing to the protocol design that lens of what's been successful, what's been challenging, what they would like to see happen with oviprene, what we in VAERS should like to see happen with oviprene. So there's that benefit in terms of what's going actually into the IDE. And then there's executing for success. And executing for success is really going to be helped by the fact that we get to leverage our already existing great relationship with Health Decisions. They have worked with us to date on all of our clinical development programs. And so we have a very strong, as you may remember, strategic partnership with Health Decisions. So through this collaboration, we get to work with Health Decisions again on the execution because that's who the NIH likes to work with as well for their contraceptive programs. And then we'll have their whole contraceptive clinical trials network, very experienced clinical trialists in contraception specifically as sites for the study. So we believe all of those factors you know, obviously the financial support, but importantly the operational support that we get to tap into both before the ID is submitted and then subsequently for the trial conduct is why this was such a great strategic relationship for us to have for the phase three.
spk02: Awesome. Thank you. That was very helpful. So just one quick one. You know, you mentioned about your core competency is getting this type of non-diluted funding, and, you know, you made these two major announcements over the last, month or so. So can you kind of tell us a little bit more about your strategy for securing such funding? How much effort do you devote to this? And should we expect any more such funding in the near future? Thanks.
spk04: Thank you. That's a wonderful question. And we are We're humble at DARI, but we are very proud of these accomplishments because these are not, these kinds of relationships and the kind of funding that came forward through both of these relationships that we're talking about, the $48.9 million for the Dear Mark I program and then the co-funding from the NIH for the Evergreen Phase III, those are not trivial amounts, obviously. And the work that goes into establishing those relationships, the diligence that those parties do on us and our ability to execute is quite considerable. And so it's not just a matter of time and patience and submitting, but it's also a matter of, frankly, DARE executing and our track record of execution that has really enabled those kind of relationships at those kind of levels with funding. And so it certainly is an ongoing part of our strategy, as Lisa touched on. You know, we really like to look at all sources of funding that can help advance our portfolio. We are, you know, we have assembled a portfolio of very interesting potential first in category products across a variety of indications. many of which have this opportunity for non-diluted funding. So we do continue to apply. As you notice, we tend to wait to break the news until we know we got the grant, even though these kinds of efforts are not just days and months, but years in the making. And so we, you know, clearly it's something we've focused on across the portfolio, and we are certainly hopeful that we will continue to be successful.
spk02: Awesome. Thank you very much.
spk04: Yes.
spk07: Next question is from the line of Kumar Raja of Brookline Capital Markets. Your line is now open.
spk05: Congratulations on all the progress, and thanks for taking my questions. First, with regard to BV1, do you expect an ad comm meeting? And also in terms of – labeling discussions and label expectations, when is that expected to take place, and how is that going to impact your strategy in terms of partnership?
spk04: Yeah, great, great question. So I think the first part, it broke up a tiny bit for me, but I think you have to be expected a panel meeting. You know, BB-1, there's a guidance document out. It's a pretty straightforward indication, so it's not something we would anticipate. In terms of the, you know, labeling and what we might expect in labeling and how that impacts the partnering strategy, you know, what I would say on that is that, again, there are approved products for bacterial vaginosis, so one can definitely look at the, you know, the approved products in terms of what is typical to go into, you know, the label. particularly Section 14 around the clinical outcomes. And so that's definitely helpful for us. It has sort of ranged and evolved over the years as different products have been approved over time. And so that certainly is something that we're looking at and we'd like to take into consideration. But clearly we can look at the existing product labels to get a sense of of how the information is typically communicated. And it is typically communicated in those labels along the lines of what we shared with the cure rates for the primary endpoint, which is typically that modified intent to treat population at a test of cure visit, which in our case is day 21 to 30. But in some cases, it's been day 7 to 14, depending on the product and the time at which it was approved. So in terms of how our labeling can impact the partnering process, Again, what I would say is we've been very thoughtfully managing this process and managing it in parallel with certain regulatory milestones and objectives as we've been advancing the program through this process. We will definitely keep everyone updated. You know, we've guided that we expect to have something that we can share with you more definitively around the commercialization strategy to support that 2022 launch by the end of this year. And that certainly aligns with, you know, this regulatory process.
spk05: Okay. And with regard to overprint, as you think about the pivotal trial, how are you thinking in terms of expectations for the PERL index and And also, what are your thoughts on potential exclusion criteria there?
spk04: Yeah, so nice question about how we think about the clinical outcomes with oviprene. And so the study that we have conducted to date, the post-coital test study, which is the pre-pivotal study, it uses a surrogate marker for contraceptive effectiveness. And so at this point in time, those are really the best data we can point to to what we would expect to how we would expect it to perform. It uses the likely, typically used effectiveness rates is what those, that pre-pivotal post-coital test study is predictive of. And so when we look at the outcome of that study and then we look at other contraceptive studies that have been published that have done the pre-pivotal post-coital test type study and then it's gone on to run full pregnancy prevention contraceptive effectiveness studies, the findings would be indicative of a product that should have a typical use effectiveness of 86 to 91%. So that puts it just right below the range of hormonal methods, which are 91% typical use effectiveness method. So that's what the PCT trial, the post-coital test trial that we ran would be predictive of. In terms of You know, the actual pregnancy prevention rate, which, by the way, affecting this rate, which tends to be kind of the typically is affected in this rate is like the inverse of your proline death. So we will know that definitively once we conduct the clinical trial that we've been talking about, the phase three. But based on the pre-pivotal, that's the range that we would be predicting based on those outcomes. And for the non-hormonal methods, I should add, that would be quite promising. I mean, this is one of the reasons that there's so much interest by a variety of parties like there at the NIH and Avoprene. It's because for the non-hormonal methods, apart from the intrauterine device, which is implanted, it's challenging to achieve that level of effectiveness. The only products that have ever historically done that are the diaphragms. They're the only product. Vaginal gels or vaginal spermicides do not have that level. They've got a 27 pearl index. You know, condoms do not have that level. They do a little bit better. They're 82% effective. But, you know, so only diaphragms have been able to achieve it, but they're a periportal method. So the ability to achieve that kind of effectiveness level with a once a month product would be quite promising for the field. And we're certainly hopeful that Overtrain will deliver the way that the post-quotas study predicted.
spk05: And in terms of the exclusion criteria?
spk04: Oh, sorry. Yeah. So that should be fairly what we've been looking at is fairly standard criteria. for contraceptive studies. So they're pretty usual in terms of the expectations both on what's required for inclusion and exclusion. And so we right now are expecting that it will quite closely mirror, you know, pending obviously feedback from the FDA, but what we're looking at would quite closely mirror other contraceptive effectiveness studies.
spk05: Okay, great. Thank you so much.
spk04: Yep.
spk07: Thank you, participants. I'll now turn the call back over to Sabrina Johnson for final remarks.
spk04: Well, thank you, everyone, for taking the time this afternoon for the call, for the great questions. We really appreciate that you took the time to hear about our recent updates, our strategies to improve options and help outcomes for women. That's what we're doing. And our ongoing commitment to drive value for all of our stakeholders. So in closing, 2021, the year was a number of potential meaningful developments for DARI, some of which we already accomplished and talked about today, and some of which are yet to come. And so during the remainder of the year, we definitely look forward to keeping you updated on our progress against the important 2021 objectives and regarding the milestones that we believe will set us up to achieve important objectives across the portfolio in 2022 and beyond as well. So thank you for your time today.
spk07: And that concludes today's conference. Thank you all for joining.
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