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spk07: Welcome to the conference call hosted by DARA Bioscience to review the company's financial results for the quarter ended March 31st, 2021 and to provide a general business update. This call is being recorded. My name is Ryan and I will be your operator today. With us today are Sabrina Martucci-Johnson, DARA's President and Chief Executive Officer, John Fair, DARA's Chief Strategy Officer, and Lisa Walters-Hofford, DARI's Chief Financial Officer. Ms. Johnson, please proceed.
spk02: Thank you. Good afternoon and welcome to our first quarter 2021 financial results and business update call for DARI Bioscience. Our plan today is to review the last quarter's results, discuss development since our last call in March, and use the time to highlight objectives and milestones anticipated for 2021. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical fact should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended March 31st, 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, 2021. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, May 13th, 2021. DARI undertakes no obligation to update any 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 lines, and have meaningful commercial opportunity. We currently have four clinical stage programs in the areas of vaginal health, sexual health, contraception, and menopause, and most of my remarks today will address these candidates. 2021 could prove to be a meaningful year for us. The advances and momentum in 2020 across the portfolio really set the stage for us to reach some important portfolio objectives in 2021. I'm going to start the call, and heads up, I'm also going to end the call with a summary of the potential meaningful development for DARI this year. This year alone, since there are many of them, and those of you new to the DARI story will likely appreciate hearing this list of 2020 milestones, 2021 milestones repeated. So first, in the area of bacterial vaginosis and vaginal health for our DARE BV1 program, during 2021, we intend to submit the NDA, enter into and announce a strategic commercialization agreement, and have a PDUFA goal date, which could result in FDA approval by year end. In the area of sexual health, specifically our Sidenafil CREAM program for female sexual arousal disorder, our Phase 2B clinical study is ongoing, and we seek to have top line data by the year end 2021. In the area of contraception, our oviprene program, we intend to file our investigational device exemption for oviprene application this year, or IDE, in the fourth quarter to enable a pivotal study start in 2022. And in the area of vaginal sexual health, specifically menopause, our DARE HRT1 program is in phase one, and we do anticipate having that study top line data this quarter, in quarter two. And then, additionally, I'm going to talk a little bit about our vaginal atrophy program in vaginal and sexual health, specifically for hormone receptor-positive breast cancer, where we seek to initiate a Phase I clinical trial later this year. So I'll start first with that vaginal health program, specifically bacterial vaginosis, our DRB1 program. So, as you know, we ended 2020 with an announcement of the positive top line data from the DRBV-free phase three study of DRBV-1 for the treatment of bacterial vaginosis. And as I mentioned, we're preparing to submit a new drug application or NDA with the FDA this quarter. Completing this clinical study on time and on budget, despite the operational constraints of the pandemic, was an accomplishment about which we are certainly proud. And it also allowed for some lessons learned that we're applying now to our sidenafil phase 2B study, and I'll address that shortly. For those of you who are new to DARI, I'd like to just take a minute to highlight the unique attributes of DARE-BB1, the positive results of our completed phase 3 study, and our next steps with the NDA submission and commercialization strategies. So, BB1 is a novel investigational thermosetting bioadhesive hydrogel. It's formulated with clindamycin clindamycin phosphate 2% as a first-line single administration vaginal treatment for bacterial vaginosis. Bacterial vaginosis is the most common vaginal condition in women of reproductive age, affecting 21 million women estimated in the United States. It causes very disruptive symptoms for her of vaginal odor and discharge, and it's importantly linked to health risks, including preterm birth, sexually transmitted infections, post-surgical infection, and pelvic inflammatory disease. Current FDA-approved treatments have clinical cure rates in the range of only 37% to 68%, leading to unresolved symptoms and linked to high rates of recurrence. For this reason, in 2018, we identified bacterial vaginosis as a persistent unmet need, impacting a large number of women, and we set about finding a potential solution. We selected DARE BV1 in light of the ability the bioadhesive hydrogel demonstrated in early clinical studies to keep the antibiotic clindamycin, which is a proven broad-spectrum antibiotic that is bacteriostatic and inhibits protein synthesis, resonant over multiple days. Simply put, in order for an antibiotic to be effective in the vaginal environment, it must remain present. We believe the single-dose convenience of this unique, clear bioadhesive hydrogel provided such an opportunity. And in our DARE BV3 phase 3 study, DARE BV1 demonstrated the potential for improved clinical cure rates versus current branded FDA-approved marketed vaginal and oral products for the treatment of bacterial vaginosis. Specifically, in the modified intent to treat population, The clinical cure rates for DRBV1 were 70% at the test of cure visit, which occurred 21 to 30 days after study drug administration. That was the primary endpoint. And 76% at the assessment visit that occurred 7 to 14 days after study drug administration. Importantly, in the per protocol population, which includes only those patients in the modified intent to treat population who didn't have a major protocol violation or who didn't receive or received any other bacterial vaginosis therapy for any reason, the clinical cure rates in that group were 77% at day 21 to 30 and 81% at day 7 to 14. And further, these results were achieved in what we believe was a representative patient population including a large proportion of patients who reported having one or more episodes of bacterial vaginosis in the 12 months before they were randomized into the study. Specifically, 75% of the intent-to-treat population reported at least one prior episode of bacterial vaginosis in the 12 months before the study. And nonetheless, the DRBV1 demonstrated the 70% clinical cure rate at day 21 to 30 in this population. And in addition, this was the first study conducted under the new 2019 FDA guidance for bacterial vaginosis treatment. The new guidelines required that all subjects in the MITT population not only meet the clinical diagnostic criteria for bacterial vaginosis, but at baseline, they also had to meet the bacterial morphology classification or Nugent score of at least seven reflective of bacterial vaginosis. So given these data, we believe DRBV1 is positioned to be an important first-line option for the treatment of bacterial vaginosis. And as mentioned, we're planning to submit that NDA to the FDA this quarter, Q2. Members of our team have, before joining DARE, been involved in numerous successful NDA submissions, but we're excited now at DARE to be submitting our first NDA as a company. DARE BV1 has both fast track and qualified infectious disease product designations. This allows for a priority review request at the time of the NDA submission. If our request is granted by the FDA, the NDA could have a PDUFA action date by the end of 2021. A 2021 FDA approval would allow for commercialization of DARE BV1 in 2022. Thus, ongoing strategic discussions and other activities to support a robust market introduction DRBV1 in 2022 if approved or underway. This year we plan to finalize and announce the commercialization strategy for DRBV1 in the U.S. I should note that we expect the launch strategy to be relatively straightforward given that antibiotics are frequently used to treat bacterial infections and vaginal administration of a drug for vaginal bacterial infection like bacterial vaginosis is common and often preferred by both clinicians and patients. since it provides a targeted localized treatment versus a systemic exposure to antibiotics. So we believe this ability to leverage existing knowledge may expand our options for commercializing Dear BV1, and John's going to discuss this in greater detail shortly. And he'll provide additional insights on how we seek to capture maximum strategic value for our shareholders in our approach to the process. I'm now going to transition to sexual health and specifically speak about our sidenafil cream program and the Phase IIb study that's ongoing. So sidenafil cream is an investigational cream formulation of sidenafil, which is the active ingredient in Viagra. Our formulation has been developed for topical administration to treat female sexual arousal disorder. Female sexual arousal disorder, or FSAD, is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal response during sexual activity and of the various types of female sexual dysfunction disorders, it's the most analogous to erectile dysfunction in men. FSAD similarly 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. There are no FDA-approved products today to treat FSAD, despite the fact that FSAD market is estimated to be as significant, if not more so, than the erectile dysfunction market in both the U.S. and the rest of the world. In March of this year, we commenced the Phase 2B RESPOND clinical study evaluating Sidenafil cream as a potential treatment for FSAD. We're targeting completion of the study and having top-line data by year-end 2021. If clinical development is successful, sedentafil cream has the potential to be the first FDA-approved FSAD treatment option. The Phase 2b response study will evaluate sedentafil cream compared to placebo in pre- and perimenopausal women over a period of 12 weeks at home. They use the product at home, and this will follow both a non-drug and a placebo run-in period. Patient-reported outcome or PRO instruments will be used to screen eligible women with FSAD and to measure achievement at the primary efficacy endpoint, namely improvement in that localized general sensation of arousal response and reduction in the distress that women with FSAD experience. In the months ahead, we will provide updates on our progress towards having top-line data by year-end. Women have suffered far too long without viable interventions to address FSAD, so we're excited to be working at the cutting edge of research focused on women's sexual health and to advance a potential first-in-category treatment option for women. I'm now going to transition to talk about oviprene in the contraceptive category. So oviprene is our novel investigational hormone-free monthly intravaginal contraceptive. As you'll likely recall, we entered into a commercial partnership agreement with Bayer in January of last year, and since that time, we've been working in collaboration with Bayer to prepare for the next stage of clinical development, which is a pivotal contraceptive study. People often ask about Bayer's level of involvement with the program right now, and as you may recall, under the terms of the agreement, Bayer provides up to two full-time equivalents for advisory support, or put another way, that's up to 80 hours per week of advisory support on the program. So our teams meet multiple times each week, and the meetings include interactions across functional areas, including manufacturing, clinical, regulatory, medical affairs, and importantly, commercialization planning. The ongoing work is designed to ensure that, pending successful completion of the pivotal study and FDA approval, we are ready as partners. Unlike DRBV1, where the pre-commercial activities in the bacterial vaginosis space we expect to be straightforward, The list for oviprene will likely be a little heavier given that it's a disruptive product for which there are no comparable products on the market today. Prior to the launch of Mirena, Bayer needed to prepare the market for the introduction of what was then a revolutionary hormone intrauterine device. Today, Mirena is a popular contraceptive brand with annual revenue of the Mirena family of products exceeding a billion dollars. So likewise, we expect oviprene will require education and pre-commercialization activities. which is why we selected Bayer as the commercial partner for our unique investigational monthly non-hormonal intravaginal contraceptive Overprene and why we entered into that partnership when we did in advance of the pivotal study. Our next significant regulatory step for Overprene involves filing an IDE with the FDA, as we must have an approved IDE in place in order to initiate our pivotal contraceptive study. and one pivotal contraceptive study is necessary for approved registration. So our current plan is to file the IDE for oviprene in the fourth quarter of this year. We are designing the pivotal study to evaluate the use of oviprene over a period of at least six months and up to 12 months, and pending the clearance of the IDE, the pivotal phase three clinical study commencement is planned for the first quarter of next year, 2022, enabling a six-month data readout by the end of 2022. I want to talk a little bit now about the HRT1 program in menopause and then briefly on FRT1 for preterm birth and then VVA1. So our 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, which can improve convenience and outcomes across multiple indications. as exemplified by the programs we're advancing today. The IVR technology was developed by Drs. Bob Langer from MIT and Bill Crawley from the Massachusetts General Hospital and Harvard Medical School. And the first application of this technology that we are clinically testing is what we call their HRT1 which is an investigational 28-day intravaginal ring containing bioidentical estradiol and bioidentical progesterone delivered together for the treatment of the vasomotor and the genitourinary syndromes associated with menopause. Earlier this year, we announced that enrollment in that Phase I study that we're conducting in Australia is complete. The objective of the Phase I is to evaluate the ability of DRHRT1 to achieve its dual release objectives as well as the ability of the IVR technology in general to release two different active drugs at two different rates as targeted. And we expect to report those top-line data this quarter. Our second application of the same technology platform is DARE-FRT1, which is an investigational intravaginal ring being developed to deliver bioidentical progesterone alone over a 14-day period. And that's for the prevention of preterm birth as well as blood or luteal phase support as part of an IVF or in vitro fertilization regimen. You may recall that we were granted an award in 2020 by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, which is a division of the NIH. to support our preclinical development activities for DER-FRT1, and that we may be eligible to receive up to approximately $2.3 million in total in grant funding to support the continued development, including the Phase 1 clinical trial that we're targeting for 2022. And before I turn it over to my colleagues, finally, I just want to mention a little bit about the DER-VVA1 Phase 1 study, since we are planning to commence that this year. So DARE VVA-1 is our proprietary investigational formulation of tamoxifen for vaginal administration to treat vulvar and vaginal atrophy or VVA in a non-hormonal approach to addressing VVA. It could be an important option for women with or at risk for hormone receptor-positive breast cancer. VVA is often the outcome of an effective breast cancer treatment regimen, and so one of the unpleasant side effects of VVA is painful intercourse. For many women, an appropriate treatment for VBA is supplemental estrogen. However, estrogen may pose a risk to women at risk for hormone receptor-positive breast cancer. Thus, our DARE VBA-1 may offer a solution for these women and others for whom hormonal treatment is not an option for their VBA. We plan to commence that Phase I clinical trial in the second half of this year in Australia, thus also leveraging our Australian subsidiary in this specific I'm now going to turn the call over to John to provide a business and corporate partnership update.
spk03: 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 GARABV1's 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 to deliver the best clinical curates 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 BV1's differentiated product profile gives us a lot of optionality as it 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 range from a full-out license, where DARE would likely be eligible to receive milestones and royalty payments, but where DARE has no role in commercialization, through to a scenario where DARE 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 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.
spk01: Thanks, John. Hey, everybody, and thanks for joining our call today. I would now like to summarize DARI's financial results for the quarter ended March 31, 2021. As you know, 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 March 31st, 2021, DARI'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 salvinofil cream, DER-BV1, oviprene, and DER-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 exercises. We ended the quarter with approximately $7.7 million in cash and cash equivalents. Between April 1st and May 10th, DARI received additional net cash proceeds of approximately $2.6 million from sales of our common stock. Following these activities and as of May 10th, 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. There are two areas I'd like to highlight. The first is grants. Grants have been an attractive source of non-diluted funding for DARE, 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 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 Larrink. 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 conditions, our liquidity and capital resources, and our risk factors in our Form 10-Q for the quarter ended March 31st, 2021 that 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, 2021. I would now like to turn the call over to the operator for Q&A.
spk07: Thank you for attending the conference call. At this time, if you do have a question, you can press star, then the number one on your telephone keypad for any questions. Again, that's star one for any questions. And our first question comes from Zygma Jala from Roth Capital Partners.
spk05: Hi, guys. Thanks for the update. I can't believe you almost have four clinical programs. Really exciting. I think just a few questions. The first one, starting with DARI BV1, just kind of wanted to have you guys perhaps elaborate on, you know, the market opportunity, you know, and how you imagine your drug being positioned. I think some of the things you mentioned was, you know, antibiotics being commonly used, you know, this is non-systemic, but I was just wondering if you could provide some clarity for folks on the line in terms of, you know, how you foresee this being positioned and how big this market is.
spk02: Yeah, that's a great question. Thank you for it. And let me give some perspective on the market and on specifically really DRBV1 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 percent, 15 to 20 percent, depending on the data that you look at, are 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 been 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, the cure rates for the products that are available today are 37% to 68%. But some 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 are 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, stand out 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 bioadhesive, 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 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 response. perception in the study. We look 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 as 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 on this team that you want to add to that?
spk03: 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. You know, we're delivering it in a convenient one-time dose. We have the highest clinical cure rates. The study was done in a heavily pretreated population and still demonstrated the highest clinical cure rates. When we revealed this kind of a profile to providers, as an example, or payers, it really resonates. So, you know, we are very excited. We don't want to over guide, but we are very excited about the opportunity.
spk02: Perfect. Maybe one more, maybe one more question and then we'll move on.
spk05: Yeah, yeah, definitely. I think the other one for me is just about DHR T1, just trying to figure out, you know, what we should be looking for in the readout that's coming up shortly.
spk02: Another 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 for 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 administering hormone therapy, which the North American Menopause Society says 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 that'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 at some 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 one. It's a PK study. So we're looking to demonstrate the appropriate levels of the hormones, and we do have comparator 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 one. 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, you know, any safety findings in the study and some sense of how the women in the study accepted the technology. But again, congrats on the progress. Thank you.
spk07: And the next question we have comes from Doug Taub from HC Wainwright.
spk04: Hi, everyone. Chris Bialis here on for Doug. I got two quick ones. The first one is about the BV1 NDA. So, as I'm sure you're aware, there's a huge agency backlog on the pre-approval inspections. How do you think that could potentially affect your NDA approval? And does the prior review put you ahead in the queue compared to some of the standard reviews?
spk02: Yeah, really interesting question. So, you know, 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. 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, you know, serious unmet need and to make it possible to have, you know, more timely interactions with the agency and thus, you know, 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, you know, 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.
spk04: Got you. And then just one quick one about the overprint IDE. You said you're on track for submission for 4Q. What, if any, are the gating events for this submission?
spk02: Another great question today is, So as some of you may remember with oviprene, you know, we had originally been looking at filing VID 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 oviprene is It's the lead review division for Obaprene, 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 CDER, 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've really used those interactions and have taken the time to do non-clinical and manufacturing-related activities to support the 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 part 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 that was a trial probably best started in 2022. You know, even though the world is opening up and we clearly felt comfortable starting the sidenafil study this year, and obviously we felt very comfortable last year running bacterial vaginosis, contraception is a little different. So for all of those reasons, everything was timed along those lines. And so the IGE filing is timed based on given the plans then of the work we wanted to do to support the ID submission and kind of how we could time it given a 2022 start and working backwards from that, you know, that's how we came up to the fourth quarter. So it's manufacturing, it's, you know, non-clinical activities, it's writing, you know, it's all of that, you know, 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.
spk04: Awesome. Thanks so much for the caller.
spk02: Yeah, absolutely.
spk07: And the next question that we do have on the line comes from Shubendu Sanway from Bookline.
spk06: Hi, I'm Shubendu calling in for Kumar from Bookline. Thanks for the update. With regards to the phase 2B response study of serigenic cream for FSAG, 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?
spk02: Yes, yeah, 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, you know, is a PDE5 inhibitor, which should have some utility in this condition. So in terms of next steps, the Phase 2B is really designed to demonstrate, obviously, 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, you know, 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 you know, 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 III 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 III, 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 a 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, you know, there's the phase three program to run, and then from a commercialization perspective, assuming positive outcome on the phase two, 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, you know, 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, DARE, 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 Obaprene partnership, as we're looking at BV1, and absolutely, you know, as we hopefully get to a successful sedentafil phase TB, that's exactly how we'll be looking at that program given what's coming behind it as well. So definitely more to follow on that, but thank you for the question.
spk06: That's very helpful. Thank you so much. Just one more question. I'm just curious of the advantages of organizing a VBA trial in Australia compared to U.S.?
spk02: Yeah, 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 a clinical trial in Australia with programs like ours. As you know, we leverage that 505 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 non-clinical 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 II. 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.
spk01: Yeah, 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 that 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 the 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 of 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.
spk02: Yeah, so you'll see that whenever it makes sense, you know, it is our strategy to run the Phase 1s 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. if required under those grants. But otherwise, Australia is a really attractive option for us.
spk06: Sounds great. Thank you so much for taking my questions.
spk02: Thank you.
spk07: And at this time, there are no other questions. Thank you. So I would like to turn it back to Sabrina.
spk02: 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 DARI stakeholders. So, in closing, 2021, as you're hearing, is a year with a number of potential meaningful developments for DARE, 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 in our bacterial vaginosis program, we're intending to submit that NDA, enter into and announce a strategic commercialization agreement, and hopefully have a PDUFA goal date, which could result in an FDA approval by year end. With our sexual health program, Sudenafil 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 Oviprene, 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 one 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 one clinical study with our 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.
spk07: And this does conclude today's call. You may now disconnect.
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