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spk04: Welcome to the conference call hosted by Daray Bioscience to review the company's financial results for the quarter ended September 30, 2021 and to provide a general business update. This call is being recorded. My name is Abigail and I will be your operator today. With us today are Sabrina Martucci-Johnson, Daray's President and Chief Executive Officer, John Fair, Daray's Chief Strategy Officer, and Lisa Walters-Hoffert, the RAISE Chief Financial Officer. Ms. Johnson, please proceed.
spk02: Thank you. Good afternoon and welcome to our third quarter 2021 financial results and business update call for Dari Bioscience. Our plan today is to review last quarter's results, discuss development since our last call in August, and use the time to highlight objectives and milestones anticipated for the balance of 2021, as well as insights into 2022. Before we begin, I'd 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 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 September 30, 2021, which was 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 this call includes time-sensitive information that is current only as of today, November 10, 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 solely and squarely focused in women's health. Our strategy is to identify, develop, and bring to market a diverse portfolio of differentiated prescription therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health. Prioritizing women's health is, of course, good for women, and through this focused approach of addressing unmet needs with candidates that have the potential to be first-line or first-in-category options, have a meaningful commercial opportunity, and, in many instances, can be developed via a 505b2 regulatory path allowing us to move directly into later stage clinical development and potentially shortening the overall development cycle for the U.S., our strategy seeks to create value and yield benefits for all of our stakeholders. Significant progress on several key clinical and corporate initiatives with the portfolio was achieved during the third quarter, and we are actively advancing clinical development and strategic partnerships to maximize the value of our pipeline candidates. Specifically, this summer we announced a grant for up to $48.9 million over approximately five years to support one of our preclinical stage contraceptive programs. Positive phase one data for our hormone therapy product candidate, DARE-HRT1. The FDA accepted our NDA for DARE-BV1 for priority review with a PDUFA target date of December 7th, 2021. And we entered into a collaborative research and development agreement, also known as a CRADA, under which a pivotal Phase III clinical study of oviprene will be supported by the NICHD's contraceptive development program and conducted within its contraceptive clinical trials network. Additionally, in September, we initiated a Phase I-II clinical study of DER-VVA1, our proprietary investigational formulation of tamoxifen for intravaginal administration to treat vulvar and vaginal atrophy in women with or at risk for hormone receptor-positive breast cancer. And we're also continuing to enroll patients in our Phase IIb response study, evaluating Sidenafil cream, 3.6%, as a treatment for female sexual arousal disorder. And for this fourth quarter, we have three important objectives. The FDA's PDUFA action on our NDA for DERBV1, plans to announce a commercial strategy for this bacterial vaginosis product candidate, And we expect to submit an investigational device exemption or IDE for oviprene to be able to commence the pivotal phase three contraceptive trial in 2022. So while our portfolio includes several programs, my comments today will focus on our NDA stage DRBV1 program, our four clinical development stage candidates, all of which are utilizing different APIs and targeting different indications, bacterial vaginosis, sexual health, contraception, hormone therapy, and breast cancer survivorship vaginal atrophy treatment. So I'll start with DARE BV1, which is in the vaginal health category of bacterial vaginosis specifically, which impacts an estimated 21 million women in the United States alone. In the third quarter, as I mentioned, we announced that the FDA accepted for filing the NDA for DARE BV1 for the treatment of bacterial vaginosis, and they granted this application priority review and set a Prescription Drug User Fee Act or PDUFA date of December 7, 2021. As a reminder, the FDA grants priority review to applicants and applications for potential drugs that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment of a serious condition. And bacterial vaginosis is a condition that can cause serious health risks and very disruptive symptoms. It has always been our goal to bring to market a product with the potential to improve outcomes and convenience for millions of sufferers, and we believe DARE BV1 has demonstrated the potential to do that. Current FDA-approved branded products indicated for the treatment of bacterial vaginosis have clinical cure rates in the range of only 37% to 68%. In the DARE BV-free Phase III study, a single vaginal dose of Darabeev-1 achieved clinical cure rates of 70% to 81%. Specifically, the Darabeev-free study met its primary endpoint, demonstrating that as a primary therapeutic intervention, a single vaginal dose of Darabeev-1 was statistically superior to placebo at the day 21 to 30 test of cure visit in the modified intent to treat population. That was 70% compared to 36% of subjects clinically cured in the placebo group. And additionally, DARE BV1 demonstrated clinical cure rates of 77% at the day 21 to 30 test of cure visit and 81% at the day 7 to 14 assessment visit in the per-protocol population, compared to 43 and 30% for placebo cream, respectively. DARE BV1 has received both Qualified Infectious Disease Product, QIDP, and fast-track designations from the FDA for the treatment of bacterial vaginosis. And under the QIDP designation, if approved, we expect DRBV1 will receive five years of market exclusivity in addition to the three years available for having generated new clinical data. We are in active strategic discussions and engaged in other activities to support a robust market launch of DRBV1 in 2022 if approved. And we plan to announce our commercialization strategy for DRBV1 in the U.S. by year end. John will provide some additional color in a moment. But before we do that, I want to talk a little bit about the other programs. So next, in the sexual health category, I'll now provide an update on sidenafil cream, 3.6%, which is our investigational product to address her version of erectile dysfunction. In March of this year, we commenced our Phase 2B clinical study evaluating sidenafil cream as an investigational cream formulation of sidenafil with the active ingredient that's 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 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, sidenafil cream has the potential to be the first FCA-approved FSAD treatment option. We are actively enrolling subjects in the Phase 2B RESPOND clinical study evaluating sidenafil cream as a potential treatment for FSAD at sites located across the United States. Our study protocol has planned an interim analysis to evaluate power calculations and trial sizings. And once we conduct that analysis, we'll be providing some guidance on the anticipated timing for the top line data readout from the trial. I'd now like to provide an update on our investigational product, Oviprene, a potential first in category option in the over $7 billion contraceptive category. So in the third quarter, as I mentioned, we announced a CRADA with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, which is part of the National Institute of Health, or NIH. This is for a pivotal Phase III study of oviprene. The CRADA reflects the NICHD's continued support for the development of oviprene and will allow us to leverage the tremendous development expertise of the NIH in contraceptive clinical studies and to share the costs of the pivotal Phase III study. Specifically, Oviprene is our novel hormone-free monthly contraceptive candidate whose commercial U.S. rights are under a license agreement with Bayer. The next stage of clinical development for Oviprene is this pivotal Phase III contraceptive study that we will conduct under the CRADA with NICHD. Grant funding previously provided by NICHD supported the conduct of our pre-pivotal clinical study of oviprene. In order to initiate the pivotal phase III study, we must have an FDA-cleared IDE in place. We currently plan to file the IDE for oviprene by the end of 2021 and, pending the FDA's review and clearance of the IDE, to initiate the study in 2022. In terms of the pivotal study, DARE will be responsible for providing clinical supplies of oviprene and coordinating the interactions with and preparing and submitting supportive regulatory documents to the FDA. DARE and NACHD together will each provide medical oversight for the trial and will work together to prepare the final report of the trial results. U.S. commercial rights for oviprene are under that license agreement with Bayer. Under the agreement, DARE receives access to Bayer's extensive clinical and market expertise through and up to approximately 80 hours per week in advisory support, while we retain control over Obaprene's development and regulatory approval process. Bayer has that right to obtain that exclusive license to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by DARE and the NICHD by making a $20 million payment to DARE. We will also be entitled to receive commercial milestone payments, potentially totaling $310 million, in addition to double-digit tiered royalties on net sales. Next, for the estimated 45 million women in the U.S. and are approaching menopause, let's talk about our investigational hormone therapy product, ARHRT1. We believe our unique intravaginal ring or IVR 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 improve convenience and outcomes across multiple indications. This IVR drug delivery technology was developed by Dr. Bob Langer from the Massachusetts Institute of Technology and Dr. William Crawley from Massachusetts General Hospital and Harvard Medical School. And the first application of this versatile technology that we've clinically tested is DARE HRT1, which specifically is an investigational 28-day intravaginal ring for hormone therapy containing bioidentical estradiol and bioidentical progesterone for the treatment of the vasomotor symptoms of menopause and the genitourinary syndrome associated with menopause. In June, we announced the positive top-line results from our Phase 1 clinical trial of DHRT1 that we conducted in Australia. For some women, hormone therapy is a highly effective treatment for the symptoms associated with menopause, such as the hot flashes and the vaginal dryness, and it may also prevent bone loss and fracture. So the delivery of hormone therapy over 28 consecutive days with no daily intervention supports DARE HRT1's potential to be a first-in-category offering and option, providing ease of use and continuous dosing to women suffering from menopausal syndrome. There are currently no FDA-approved products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple consecutive weeks, as is the design of DARE HRT1. Our clinical development strategy is to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, the estradiol and progesterone, and to seek approval using the 505 regulatory pathway in order to obtain marketing approval of DARE-HRT1 in the U.S. We are in the process of updating our regulatory and clinical development strategy given these positive Phase I data, and we will be providing guidance on next steps with this program as soon as possible. We've not yet commenced clinical testing of our second application of this novel IVR technology, specifically DER-FRT1, for the prevention of preterm birth and luteal phase support during IVF procedures. However, we have received a grant from the NIH for certain non-clinical activities with the potential for additional end-age funding to support a phase one study of DER-FRT1, and we will continue to provide updates as those activities advance. And finally, for the more than 3.8, as you know, more than 3.8 million women in the U.S. have a history of breast cancer. And hormone receptor positive is the most common type of breast cancer. And the prevalence of vulvar and vaginal atrophy in postmenopausal breast cancer survivors is estimated to be 42 to 70%. We would like to provide an option for those women. And that is in our program, Dear VVA1. As I mentioned in my opening remarks, we initiated a Phase 1-2 clinical trial in Australia in the third quarter for this breast cancer survivorship vaginal atrophy treatment program, DARE VVA-1. DARE VVA-1 is our proprietary investigational formulation of tamoxifen for vaginal administration to treat VVA. As a non-hormonal approach to addressing VVA, it could be an important option for women with a history of or at risk for hormone receptor-positive breast cancer. VVA is often the outcome of effective breast cancer treatments, and it can lead to vaginal discomfort, including painful intercourse, which, as you can imagine, causes significant distress. For many women, an appropriate treatment for VVA is supplemental estrogen. However, estrogen may pose a risk to women at risk for hormone receptor-positive breast cancer. So VVA-1, DARE VVA-1, may offer a solution for these women and for others for whom hormonal treatment is not an option. We currently expect to report top line data from the DARE VBA1 Phase 1-2 study during 2022. I will now turn the call over to John to provide a strategic update on DARE VBA1.
spk03: Thank you, Sabrina. The DARE VBA1 partnering process has been purposely aligned with the DARE VBA1 regulatory process. With the NDA for DARE BV1 under priority review by the FDA, we have accelerated the three main commercialization strategies under discussion, which 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, a second scenario where we strategically partner DARE BV1 but retain the option to have a role in the commercialization of the product, And a third scenario where we can play a direct and active role in commercialization, that includes being able to fully market the product through an introduction via partnership with a full service contract sales organization or CSO. All three options remain under active discussion as we approach the December 7th PDUFA target action date. And as a company, we reflected across our entire portfolio of product candidates, we are really focused on providing better therapeutic options for women. In the context of DARE BV1, we are motivated to find the right commercial structure for the brand because we believe it should be the new standard of care for the treatment of bacterial vaginosis. And as Sabrina previously mentioned, currently available FDA-approved treatment options for bacterial vaginosis work about half the time on average. What has been particularly insightful for us and our team based on real-time market insights that we mentioned during our previous update call is there's a fundamental underestimation of the effectiveness of the currently approved products both on the part of the healthcare providers and the payers. We believe this is likely due to the lack of innovation in the category and the lack of promotion for bacterial vaginosis products. And based on our market research and our current understanding of the market, it's our belief that Dara BV1 will be the top promoted brand in the category at the time of its launch if it's approved. That will give Dara BV1 commercial team, whether that's Dara or a partner, a dominant share of voice in the category. And that's an important point. As those of you who are familiar with pharmaceutical marketing can appreciate, being able to dominate share of voice is generally viewed as a key performance indicator for success. And in addition to being able to dominate share of voice, we expect the in-market messaging to feature the differences in clinical cure rates for DERA BV1 versus other FDA-approved products, as well as positive data on the patient experience. In our DARE BV-free study, we saw positive patient-reported data that suggests DARE BV-1 was able to rapidly resolve some of the most bothersome symptoms of bacterial vaginosis for patients, including the vaginal odor and vaginal discharge. When you add the potentially best-in-class clinical curates in the category with the opportunity for the patient to experience rapid relief of some of the most bothersome symptoms, all by the way achieved with a single administration, a one-time vaginal dose, We believe that the product is well positioned for success, pending ongoing discussions with the FDA and approval of our NDA. I'd also like to highlight another insight from the recent round of market research specific to payers. Payers, as many of you know, are absolutely critical to the success of any new product, and that's particularly true for women's health. And our research has shown that payers are very interested in a product that positively impacts patients who have been previously treated for bacterial vaginosis, or what you might call recurrent patients. The good news for us and for DARE BV1 is that the DARE BV3 study data suggests DARE BV1's potential to produce the same high clinical cure rate in recurrent patients as in patients who have never been treated for bacterial vaginosis. Therefore, any positive impact on recurrent patients is viewed as a key factor that could influence payer coverage considerations for DARE BV1. So in summary, we are encouraged with the progress of our discussion specific to DARE PV1 commercialization. We are excited about the prospect of bringing an important new therapeutic option to women and healthcare providers. And with that, I'm going to turn the call over to Lisa to give you a financial update.
spk01: Thank you, John. And thank you all for joining us today. I would now like to summarize DARE's financial results for the period ending September 30th, 2021. As you know, Derry'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 September 30, 2021, DARE's general administrative expenses were approximately $2.2 million, and our R&D expenses were approximately $10.7 million. The quarter's increase in R&D expenses compared with the same period in 2020 primarily reflects increases in the cost of clinical, regulatory affairs, and other development activities related to the ongoing self-beneful cream 3.6% phase 2b respond clinical trial and manufacturing and regulatory activities for overprint. Our comprehensive loss for the quarter was approximately $13 million. During the nine months ended September 30th, 2021, net cash proceeds from financing activities were approximately $59.8 million and primarily reflected sales of stock under our ATM program. We ended the quarter with approximately $45.6 million in cash and cash equivalents. As of November 8th, 2021, we have approximately 76.6 million shares of common stock outstanding. I'd like to take a moment to highlight a few other arrangements that we expect will favorably impact our cash burn going forward. As we've discussed in the past, recall that under Australia's current Research and Development Tax Incentive Program, eligible companies conducting research and development activities in Australia may be eligible to file for and receive up to 43.5% of their eligible expenses as a cash payment the following year. We intend to apply for the maximum amount allowed for reimbursement under the program in early 2022 based on our allowable R&D expenses related to the DARE HRT-1 and the DARE VBA-1 clinical trials that were ongoing in this current year, 2021. Second, as Sabrina had mentioned, under the CRADA with the NICHD, DARIUSC agreed to contribute $5.5 million between July 2021 and April 1st, 2023, toward the total estimated cost to conduct the phase three pivotal clinical study of overprime. To date, we have paid $1.5 million of that amount. DARI will also be responsible for providing the clinical surprise of overprime for the study, and the NICHD will be responsible for the other costs related to the conduct of the pivotal study, and will also manage the payment of expenses to third parties. We believe the NICHD's contraceptive trial experience and financial support should allow for the completion of the oviprene pivotal study in an efficient and cost-efficient manner. Finally, grants have continued to be an 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 also encourage all investors to review the more detailed discussion of our financials and financial condition, our liquidity and capital resources, our risk factors in our Form 10-Q for the quarter ended September 30th, 2021, which we filed today. as well as in our annual report on Form 10-K for the year-ended December 31, 2020 that was filed on March 30. I would now like to turn the call over to the operator for questions and answers.
spk04: Thank you for attending the conference call. To ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound or hash key. Please stand by while we compile the Q&A roster. Again, you will need to press star one on your telephone. Our first question comes from the line of stake, Vejala, with Ross Capital Partners. Your line is now open.
spk05: Thanks for taking my question, and congrats on the progress, and thanks for the nice update. I just have three quick ones. I'm just going to ask them all at once. I think the first one is just what's needed to be completed for the IDE for overprint, and then the second one is is for the FSAD program or the response study. I was just wondering if you could comment on the endpoints being used since, as you noted, Sabrina, this will be the first therapy approved for FSAD, so just on the pros you're using and things like that. And then lastly, on the IVR technology, just wondering if you plan to do some additional patient, not patient, but investor education and things like that since this is now being used. forth two programs, and I don't know, maybe are you even considering perhaps using it for a third?
spk02: Thank you, first of all. Those are great, great questions, all three of them, and really happy to have the opportunity to answer them. So first of all, on the oviprene IDE, the easiest way to think about it, because it's a little backwards of how we normally think about things in drug development, but – and The IDE is in many ways similar to an IND. I know it sounds backwards because we've already completed a human study with oviprene, and that wouldn't happen if you were on the drug side, but the device division leads the review of oviprene as a combination product. And so the IDE follows that completion of that pre-pivotal study that we did. But the way to think about it is it has you know, kind of all the aspects in it that you would expect to have in an IND to give the agency comfort that we would be going into, you know, a phase three trial. And so all the kind of manufacturing, the non-clinical, and in this case also our human proof of concept pre-pivotal study that we conducted. So all of that goes into the IDE. And I've mentioned on previous calls that What's actually really nice about working with the device division leading the review of the FDA, although both divisions are wonderful, but the device division is they provide the sponsor opportunities to engage with them multiple times if you elect to before you even file your IDE. So they have a different set of meeting standards. So it's helpful for a sponsor to have those kind of conversations just to make sure we're clear on what the expectations are for what goes in an IDE. But bottom line, it's quite similar to an IND, and our plan is right now to work on getting that into the FDA before the end of this year so that we can basically start the study during 2022. So it's a little bit of an artificial deadline for ourselves because we're planning to start the study next year, but our goal is to get it in before the end of the year. In terms of the Sidenafil program and the question you had on the primary endpoints, you're correct. As I mentioned, as the first sponsor working on a program like this in collaboration with the FDA, one of the important aspects of that was the time we spent aligning with the FDA on the primary endpoint, and not just that, but actually the studies we conducted in women with female sexual arousal disorder called content validity studies to design the primary endpoint. And the objective in any patient-reported outcome is that you identify something that the patient can answer, in this case she can answer, that identifies and reflects her most bothersome and captures, importantly, improvement in those most bothersome symptoms of the condition. And so in the case of female sexual arousal disorder, distress is actually one of her most bothersome aspects of the condition, and it's linked to the diagnosis. Again, I can't say often enough how similar it is to erectile dysfunction. So just like erectile dysfunction has a physical component in men in terms of the lack of sexual response, to activity, there's also that sort of mental component of the distress that it causes. So very analogous. So our primary endpoint is a co-primary endpoint that will evaluate her level of distress with her sexual response. And then importantly, again, as analogous as we can be, it's looking at that physical genital arousal response that she is experiencing. And so that is the co-primary endpoint It's based on a lot of historic data, frankly, in the sexual dysfunction field across a variety of different sexual dysfunction indications and reflects the content validity work to target those specific questions that really reflect what's most bothersome to her. That's the primary endpoint, but because this is a phase 2b and because the FDA is very collaborative with the sponsor that's doing something new like this, This trial includes a number of secondary and exploratory endpoints as well, so that we can really get a clear understanding from this trial of, you know, what does she really notice in terms of what's happening? How is that reflected in a response for her? And it's really designed to allow us to advance and design the best Phase III program possible. And that interim analysis is designed really for powering reasons, that because when you're using a patient-reported outcome for the first time, You make estimates based on lots of nice published data on your power calculations, but FDA allows sponsors this kind of an opportunity for an interim analysis for powering specifically around the use of new endpoints like this. So we obviously wanted to take advantage of that. Third, your question was around the IVR technology and educating investors. It's great feedback. We really should take an opportunity to do that. It's a great technology that was, as I mentioned, developed initially by Bob Langer at MIT and Bill Crowley, and it's really designed to give a lot of flexibility in how you deliver a product vaginally to women. It's a great platform technology any time you want to deliver something over weeks or months. and that's really how we're leveraging it, and to your point, yes, these are the first two places that we're looking to use the technology, but we do view it as a platform in our portfolio as a way to deliver drugs any time you're thinking about something she may need over multiple days because it provides the convenience of not having to have daily dosing. It provides the convenience of still able to achieve systemic therapeutic levels of drugs, as we've demonstrated with HRT1 for estradiol and progesterone, but without first-path metabolism, so often can avoid certain side effects or dosing limitations that might otherwise be present. But we will continue, as the programs advance, to really educate about the technology because it's truly a platform in our portfolio. And thanks for the three great questions.
spk05: You're welcome.
spk04: Our next question comes from the line of Chris Bialas with HSC Wainwright. Your line is now open.
spk06: Hey, everyone. How are you all doing? Thanks so much for taking my question. So I actually have two. The first is, you know, we're getting pretty close to this BV1 KADUFA date and hopefully the commercialization. But it looks like the SG&A spend has only modestly increased in this quarter. So how should we think about that in 4Q and beyond, kind of given the timing? And then I have one more.
spk02: Great. Well, great question on that. And really, that's because of something that we've mentioned a couple times previously, but maybe I can give a little more color around. As John highlighted, we obviously are doing certain activities to prepare for an ultimate, hopefully, commercial launch of that product pending FDA approval of the NDA. And And a lot of that is really around the patient journey, the landscape, the payer work that John highlighted nicely on today's call. But a lot of the real activities come in a product like this after you have the final labeling from the FDA. So there are certain manufacturing activities that simply are not feasible until we have the final label from the FDA. and really the procurement and development of the promotional pieces and things like that. And because we're in strategic discussions as well around commercialization strategy, there's no need for us to ramp kind of personnel or anything like that, right? So really the way to think about it is a lot of those activities will come after the PDUFA date. And really because the partnering strategy will have such a significant impact on what, if any, of those expenses are borne by DARE. More to follow on that as we shine some light on that.
spk06: Okay, great. Thank you. And then just one on overprinting, really. So you're mentioning, you know, that you can get this feedback for the ID from the FDA. Have you heard anything so far? What's kind of that looked like? And regarding the trial, you said in a 2022. So should we expect top line data by the end of the year, or by the end of 2022?
spk02: Yeah, great, great, great question. So, we have shared previously that we have taken advantage of this process that the FDA Device Division allows for what's called pre-submission meetings with them for your IDE. Now, to be clear, they're high-level meetings. They don't, under the pre-submission process, the FDA doesn't actually review anything. You know, it's most analogous to a pre-IND kind of meeting process where you get to tell the FDA what you're thinking, you know, what you're planning, and they tell you kind of big picture conceptually. Does that make sense? Is that a good idea or not? But really, the review of the IDE happens when you submit it. The device division is also different from the drug division in the sense that it is very common for an IDE submission process to be iterative, meaning that you submit, they finally, you know, so our goal is to submit before the end of the year, the FDA reviews, and they can come back to you in a few ways. They can come back to you and say, hey, we were really hoping to see XYZ, please resubmit, right, go do that and resubmit before we let you start your phase three trial. That's actually very, very common. to happen. Second is they could tell you, you know, we need you to do X, Y, Z, but just go ahead and do that and submit it to us. And as soon as you do that, you're good to go. You don't have to resubmit the full IDE. Or third, they can say, you know, great job. You're good to go. Go start the phase three. Oviprene is a very, I mean, what's exciting about oviprene is how completely novel and disruptive it has the potential to be in the contraceptive category. But as a novel product, one of the things that, you know, will certainly be an area of consideration of the FDA is the final design of that pivotal study. So drug division typically requires 12-month studies. Device division typically requires six-month studies. But the device division is not typically accustomed to looking at monthly products. Most of the device division products are things like condoms and, you know, diaphragms that are on-demand products, whereas the drug division is more accustomed to that. So to your question on when to expect data, we're going to know a lot more about that after the FDA has an opportunity to review our IDE and gives us definitive feedback. You know, there's clear reviews on typically a number of cycles and things like that that you need to study, but in terms of duration for really a safety perspective, we're not going to know that. But typically, contraceptive trials are open label, which does provide the sponsor an opportunity to look at data without, you know, kind of statistical penalties you'd have otherwise. and share, you know, to pick points and times to do kind of interim analysis and share them. And so certainly as we learn more about the FDA expectations, we will be able to guide more around what is going to be possible, you know, or not in 2022. And so at this point, all we can really say is that we plan to initiate in 2022 pending the FDA clearance of that IDE. And once we get further into that process, we'll be able to provide a lot more guidance around timelines.
spk06: Awesome. Thank you so much.
spk02: Yeah.
spk04: And as a reminder, to ask a question, you will need to press star 1 on your telephone. Our next question comes from the line of Kumar Raha with Brookline. Her line is now open.
spk07: Hi. I'm for Kumar. Thanks for the update. With regards to the phase two pre-trial better plan next year, I was just wondering how do you see the patient enrollment progressing, given that we are still seeing effects of the pandemic? You may have had discussions with NIH. Could you please provide some color on that?
spk02: Yeah, thanks. Thanks. All the questions today have been so great. Really great question. And we absolutely have been having that discussion with the NIH because, interestingly, at the beginning of the pandemic, the NIH found in other contraceptive studies that they had going at that time that it actually, and now I'm talking about, you know, March of 2020 when we went into shutdown. and sheltering in place, they found that it had a very significant impact on enrollment. And in fact, they halted certain of their contraceptive development programs at that time because simply as one might anticipate, women were not comfortable at that time contemplating a contraceptive clinical trial in the midst of a pandemic where there weren't vaccines and there was a lot of uncertainty. And importantly, there were a lot of shelter-in-place mandates Clearly, we're still in a strange world as it pertains to COVID. And so certainly as a company, we certainly did not want to contemplate trying to run this trial in 2020. And quite frankly, we weren't sure that it would be the right thing to do in 2021 either. Right? That's some of our planning and timing. You know, but we do believe in the NIH, you know, I can't obviously speak for the NIH, but I can speak to our planning conversations with them is that we both feel comfortable that, you know, in 2022 and given other programs that have resumed in the contraceptive clinical development category, and how enrollment is going with those studies, that it is quite reasonable to go ahead and think about starting a contraceptive clinical trial at that time. Having said all of that, we see it, right, changes real time. So, but hopefully, you know, we're reaching a point where the COVID situation is hopefully only going to get a little easier to manage and predict. But that's the thinking right now is that it should be feasible to go ahead and start a trial like this in 2022.
spk07: Right. I understand. That was useful. Thank you.
spk00: Yeah.
spk07: Just another quick question. With regards to the VBA study in Australia, this is early, but are you planning for a potential phase three in Australia? And how similar are the regulatory requirements here in the U.S. with that in Australia? Yeah.
spk02: Yeah, so I will say we really love our collaborators in Australia. We have certain clinical research organizations that we work with there and then sites, you know, in women's health that we work with there. And they are exceptional collaborators for Phase I and even a Phase I-II trial like the VBA-1 study. And it would also be an exceptional place to consider having sites, a couple sites, right, couple to a few sites for a phase two, a bigger phase two or phase three program. Not really feasible to really think about your entire, right, clinical trial enrolling there. Just they don't have the population and they don't have the number of investigators that are really specialized in women's health. Those are the ones that we're working with right now to conduct, you know, later stage trials. But it's absolutely a great venue to be a participant. in a later stage trial. And what works so beautifully about the phase one stage programs and why we have been so, I would say, prolific in running our phase one programs in Australia is because you can, and because of the nature of our programs, we're often using a known active ingredient, right? Not a new chemical entity, but a known. It allows us to pursue a regulatory process that's very different from what you'd have to undergo into the U.S. before you can get into phase one. And specifically, It's simply an ethics committee review, so much more expeditious and the paperwork burden is much less than what's required for an IND. But as you advance into later stage trials in Australia, not so much. Then it gets to be kind of the same as what's required in the US, but it still has the benefit of that wonderful tax incentive, the R&D rebate that Lisa outlined. So it will always be a place that we consider for sites for later stage programs, but it is a place that we are trying to do as much of our phase one work there as possible because it makes it, you know, it's 43% specifically on the rebate, but the reality is things are less expensive there in general. So a lot of real financial benefits to conducting our phase one programs there.
spk07: Thank you. Thank you for taking my questions.
spk02: Great. Thank you. Those are great questions as well.
spk04: And there are no further questions. I'll now turn the call back over to Ms. Jensen for closing remarks.
spk02: Thank you. Thank you so much. I really appreciate everyone taking the time this afternoon to hear about our updates and our ongoing commitment to really drive value for all of our shareholders and stakeholders. And in closing, hopefully you've gotten a sense that 2021 has been so far a year with a number of meaningful developments and more potential meaningful developments, so some of which we've already accomplished and some of which are yet to come. And so during the remainder of the year, we really look forward to keeping you updated on our progress against the remaining important 2021 objectives. those milestones, and specifically also regarding the milestones that we believe will set us up to achieve important objectives across the portfolio in 2022 and beyond. So thank you so much, and we look forward to keeping you updated.
spk04: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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