Dare Bioscience, Inc. Q3 FY2021 Earnings Call

Welcome to the conference call hosted by Daré 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’ll be your operator today. With us today are Sabrina Martucci Johnson, Daré’s President and Chief Executive Officer; John Fair, Daré’s Chief Strategy Officer; and Lisa Walters-Hoffert, Daré’s Chief Financial Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon and welcome to our third quarter 2021 financial results and business update call for Daré Bioscience. Our plan today is to review last quarter’s results, discuss developments 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 I 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 provision to the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-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. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. Daré is solely and squarely focused on 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, having meaningful commercial opportunity, and in many instances can be developed via a 505(b)(2) 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 1 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 7, 2021. And we entered into a collaborative research and development agreement, also known as a CRADA, under which a pivotal Phase 3 clinical study of Ovaprene 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 1/2 clinical study of DARE-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 2b RESPOND study evaluating Sildenafil 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 DARE-BV1, plans to announce a commercial strategy for this bacterial vaginosis product candidate, and we expect to submit an investigational device exemption or IDE for Ovaprene to be able to commence the pivotal Phase 3 contraceptive trial in 2022. While our portfolio includes several programs, my comments today will focus on our NDA stage DARE-BV1 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-BVFREE Phase 3 study, a single vaginal dose of DARE-BV1 achieved clinical cure rates at 70% to 81%. Specifically, the DARE-BVFREE study met its primary endpoint, demonstrating that as a primary therapeutic intervention, a single vaginal dose of DARE-BV1 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 treated in the placebo group. Additionally, DARE-BV1 demonstrated clinical cure rates of 77% at the day 21 to 30 tested cure visit and 81% at the day seven 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. Under the QIDP designation, if approved, we expect DARE-BV1 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 DARE-BV1 in 2022, if approved, and we plan to announce our commercialization strategy for DARE-BV1 in the U.S. by year-end. Next in the sexual health category, I'll now provide an update on Sildenafil Cream 3.6%, which is our investigational product to address female sexual arousal disorder. In March of this year, we commenced our Phase 2b clinical study evaluating Sildenafil Cream as a formulation of Sildenafil for topical administration to treat female sexual arousal disorder. 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 than the erectile dysfunction market in both the U.S. and the rest of the world. If our clinical development is successful, Sildenafil Cream has the potential to be the first FDA approved FSAD treatment option. We are actively enrolling subjects in the Phase 2b RESPOND clinical study evaluating Sildenafil 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 size and then 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 Ovaprene, 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 Institutes of Health or NIH. This was for a pivotal Phase 3 study of Ovaprene. The CRADA reflects the NICHD’s continued support for the development of Ovaprene, and 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 3 study. Specifically, Ovaprene 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 Ovaprene is this pivotal Phase 3 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 Ovaprene. In order to initiate the pivotal Phase 3 study, we must have an FDA cleared IDE in place. We currently plan to file the IDE for Ovaprene by the end of 2021, pending the FDA’s review and clearance of the IDE to initiate the study in 2022. In terms of the pivotal study, Daré will be responsible for providing clinical supplies of Ovaprene and coordinating the interactions within preparing and submitting supportive regulatory documents to the FDA. Daré and NICHD together will each provide medical oversight for the trial and will work together to prepare the final report at the trial results. U.S. commercial rights for Ovaprene are under that license agreement with Bayer. Under the agreement, Daré 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 Ovaprene’s development and regulatory approval process. Bayer has the right to obtain that exclusive license to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by Daré and the NICHD, by making a $20 million payment to Daré. 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. who are approaching menopause, let's talk about our investigational hormone therapy product DARE-HRT1. 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 first 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 genital urinary syndrome associated with menopause. In June, we announced the positive top-line results from our Phase 1 clinical trial of DARE-HRT1 that we conducted in Australia. For some women, hormone therapy is a highly effective treatment for the symptoms associated with menopause, such as hot flashes and 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 an option, providing ease of use and continuous 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, 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(b)(2) 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 1 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 DARE-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 NIH funding to support a Phase 1 study of DARE-FRT1, and we will continue to provide updates as those activities advance. And finally, 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. 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 DARE-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-VVA1. DARE-VVA1 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 for hormone receptor positive breast cancer. So DARE-VVA1 may offer a solution for these women and for others for whom hormonal treatments are not an option. We currently expect to report top-line data from the DARE-VVA1 Phase 1/2 study during 2022. I will now turn the call over to John, to provide a strategic update on DARE-BV1.

Thank you, Sabrina. The DARE-BV1 partnering process has been purposely aligned with the DARE-BV1 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 Daré; a second scenario where we strategically partner DARE-BV1, but retain the option to have a role in the commercialization of the product; and the third scenario where we can play a direct and active role in commercialization, including 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 7 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. 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 DARE-BV1 will be the top promoted brand in the category at the time of its launch if it's approved. That will give DARE-BV1 commercial team, whether that's Daré or a partner, a dominant share voice in a category, and that's an important point, as those of you who are familiar with pharmaceutical marketing can appreciate being able to dominate share voice is generally viewed as a key performance indicator for success. In addition to being able to dominate share voice, we expect the end market messaging to feature the differences in clinical cure rates for DARE-BV1 versus other FDA approved products, as well as positive data on the patient experience. In our DARE-BVFREE study, we saw positive patient-reported data that suggests DARE-BV1 was able to rapidly resolve some of the most bothersome symptoms of bacterial vaginosis for patients, including vaginal odor and vaginal discharge. When you add the potentially best-in-class clinical cure rates in the category with the opportunity for the patient to experience rapid relief of some of the most bothersome symptoms, all 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. Our research has shown that payers are very interested in products that positively impact 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-BVFREE study data suggests DARE-BV1’s potential to produce the same high clinical cure 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 discussions specific to DARE-BV1 commercialization. We are excited about the prospect of bringing important new therapeutic options to women and healthcare providers. And with that, I'm going to turn the call over to Lisa, to give you a financial update.

Thank you, John. And thank you all for joining us today. I would now like to summarize Daré’s financial results for the period ending September 30, 2021. As you know, Daré’s business model is to assemble, advance, and monetize a portfolio of novel product candidates in women's health. As a result, our expenses 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, Daré’s general and 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 Sildenafil Cream 3.6% Phase 2b RESPOND clinical trial, and manufacturing and regulatory activities for Ovaprene. Our comprehensive loss for the quarter was approximately $13 million. During the nine months ended September 30, 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 8, 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-HRT1 and the DARE-VVA1 clinical trials that were ongoing in this current year 2021. Second, as Sabrina had mentioned, under the CRADA with the NICHD, Daré agreed to contribute $5.5 million between July 2021 and April 1, 2023, for the total estimated cost to conduct the Phase 3 pivotal clinical study of Ovaprene. To date, we have paid $1.5 million of that amount. Daré will also be responsible for providing the clinical supplies of Ovaprene for this study, and the NICHD will be responsible for the other costs related to the conduct of the pivotal study, and we'll 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 Ovaprene pivotal study in an efficient and cost-efficient manner. Finally, grants have continued to be an attractive source of non-dilutive funding for Daré, 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, and our risk factors in our Form 10-Q for the quarter ended September 30, 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.

Our first question comes from the line of Zegbeh Jallah with ROTH Capital Partners. Your line is now open.

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 Ovaprene? And then the second one 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 some of 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 investor education and things like that, since this is now being used for two programs. And I don't know maybe are you even considering perhaps using it with third?

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 Ovaprene IDE, the easiest way to think about it, because it's a little backwards from how we normally think about things in drug development. But the IDE is in many ways similar to an IND. I know it sounds backwards, because we've already completed a human study with Ovaprene. And that wouldn't happen if you were on the drug side. But the device division leads the review of Ovaprene as a combination product. And so the IDE follows the completion of that pre-pivotal study that we did. But the way to think about it is it has 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 a Phase 3 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, what's actually really nice about working with the device division leading the review of the FDA is that both divisions are wonderful. But the device division is they provide the sponsor opportunities to engage with them multiple times if you'd like 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 this kind of conversations just to make sure we are clear on what the expectations are for what goes in an IDE. But the bottom line is it's quite similar to an IND. 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 Sildenafil, 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. 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 symptoms and captures importantly improvements in those most bothersome symptoms of the condition. And so in the case of female sexual arousal disorder, distress is one of her most bothersome aspects of the condition and it's linked to the diagnosis. So, 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 mental component and 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 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 clearer understanding from this trial of what does she really notice in terms of what's happening, and how is that reflected in a response for her, and it's really designed to allow us to advance and design the best Phase 3 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 published data on your power calculations, but FDA allowed the sponsors this kind of an opportunity for an interim analysis for powering specifically around the use of new endpoints like that. So we obviously wanted to take advantage of that. Then, 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 anytime 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 anytime 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 DARE-HRT1, for estradiol and progesterone. But without first-pass 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.

Thank you.

Our next question comes from the line of Chris Bialas with H.C. Wainwright. Your line is now open.

Hey everyone. How are you all doing? Thanks so much for taking my question. So I just have two. The first is, we're getting pretty close to the BV1 PDUFA date, and hopefully the commercialization. But it looks like the SG&A spend is 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.

Great question on that. And really, that's because of something that we've mentioned a couple of 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 a lot of that is really around the patient journey, the landscape, the paperwork, 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 Daré, more to follow on that as we shine some light on that.

Okay, great. Thank you. And then just one on Ovaprene, really. So you're mentioning that you can get this feedback for the IDE from the FDA. Have you heard anything so far? What's kind of looked like? And regarding the trial you said in 2022, so should we expect top-line data by the end of the year or by the end of ‘22?

Thank you for the question. We have previously mentioned that we've utilized the FDA's pre-submission meetings for our IDE. To clarify, these meetings are high-level discussions where the FDA doesn't review anything directly. It's similar to a pre-IND meeting where we can outline our plans, and they can provide general feedback on whether our approach makes sense. The actual review occurs when the IDE is officially submitted. The device division's submission process often involves iterations; our aim is to submit before the year ends. The FDA can respond in various ways: they might request additional information for resubmission, ask us to complete certain tasks without needing a full resubmission, or they could simply approve us to move forward with Phase 3. Ovaprene is particularly exciting because it could be a game-changer in contraception. However, as a novel product, the FDA will closely evaluate the design of our pivotal study. While the drug division usually requires studies lasting 12 months, the device division typically looks for six-month durations but isn't used to evaluating monthly products. Regarding when we can expect data, we'll have a clearer understanding after the FDA reviews our IDE and provides feedback. Contraceptive trials are often open-label, allowing the sponsor to analyze data without penalties and conduct interim analyses. As we gain more insight into the FDA's expectations, we will be better positioned to project what can be achieved in 2022. For now, we expect to initiate the trial in 2022, pending the FDA's clearance of our IDE. As we progress, we will share more detailed timeline guidance.

Awesome. Thank you so much.

Our next question comes from the line of Kumar Raja with Brookline. Your line is now open.

Hi, I am Shubendu for Kumar. Thanks for the update. With regards to the Phase 3 Ovaprene trials that are planned next year, I was just wondering how do you see the patient enrollment progressing given that we are still seeing the effects of the pandemic. You may have had discussions with NIH. Could you please provide some color on that?

Thanks for the great questions. We have indeed been in discussions with the NIH. At the beginning of the pandemic in March 2020, the NIH noticed that enrollment in other contraceptive studies was significantly impacted. They even halted some of their contraceptive development programs during that time because many women were hesitant to participate in clinical trials amid the uncertainty of the pandemic and the absence of vaccines. We recognized that trying to run our trial in 2020 was not advisable, and we were unsure if it would be appropriate in 2021 as well. However, we have confidence in the NIH and, based on our planning conversations with them, we both agree that by 2022, with the resumption of other programs in contraceptive clinical development and the progress in their enrollment, it would be reasonable to consider starting a contraceptive clinical trial. We do recognize that circumstances may continue to change, but we are hopeful that the COVID situation will become easier to manage, which leads us to believe that initiating this trial in 2022 should be feasible.

I understand. That was useful. Thank you. Just another quick question. With regards to the VVA study in Australia, this is early, but are you planning for a potential Phase 3 in Australia? And how similar are the regulatory requirements here in the U.S. with that in Australia?

We really appreciate our collaborators in Australia, including certain clinical research organizations and sites in women's health. They have been exceptional partners for our Phase 1 and Phase 1/2 trials, like the VVA1 study. Australia would also be a great location for several sites for a larger Phase 2 or Phase 3 program. However, it's not feasible to think about enrolling an entire clinical trial there due to the limited population and the scarcity of specialized investigators in women's health. Currently, we're working with those collaborators for later-stage trials, and Australia is certainly a valuable venue for participation in those trials. Our success in running Phase 1 programs in Australia is largely due to the nature of our studies, as we typically use known active ingredients rather than new chemical entities. This allows us to navigate a regulatory process that is much simpler than what is needed in the U.S., where approvals require a more extensive IND process. In Australia, the approval mainly involves an ethics committee review, which is much quicker and involves less paperwork. As we move to later-stage trials in Australia, the requirements align more closely with U.S. standards, but the tax incentive, particularly the R&D rebate, still makes Australia attractive for later-stage programs. We're keen to conduct as much of our Phase 1 work there as possible because of the 43% rebate, and generally, it is less expensive to run these programs, leading to significant financial advantages.

Thank you for taking my questions.

Great. Thank you. Those are great questions as well.

As there are no further questions, I'll now turn the call back over to Ms. Johnson, for closing remarks.

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 and those milestones, and specifically also regarding the milestones that we believe will set to achieve important objectives across the portfolio in 2022 and beyond. So, thank you so much. And we look forward to keeping you updated.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.