Dare Bioscience, Inc. Q1 FY2022 Earnings Call

Welcome to the conference call hosted by Dare Bioscience to review the company's financial results for the year ended March 31, 2022, and to provide a general business update. This call is being recorded. My name is Delfin, and I'll be your operator today. With us today are Ms. Sabrina Martucci Johnson, Dare's President and Chief Executive Officer; Mr. John Fair, Dare's Chief Strategy Officer; and Ms. Lisa Walters-Hoffert, Dare's Chief Financial Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon, and welcome to our First Quarter 2022 Financial Results and Business Update Call for Dare Bioscience. Our plan today is to review our first quarter results, discuss developments since our last call in March, and use the time to view our business strategy and highlight our objectives and milestones anticipated for 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 annual report on Form 10-K for the year ended December 31, 2021, which is filed on March 31, 2022. 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 12, 2022. Dare undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. As you know, Dare is solely and squarely focused on women's health. It is our belief that prioritizing women's health is not only good for the many women lacking effective or convenient therapeutic choices, but also for a broad set of stakeholders, including their families, partners, and of course, our shareholders. We typically use these calls to update you on the milestones we've achieved to date and the upcoming milestones that we anticipate, and we will do that today. We'll provide an update on the collaboration with Organon to commercialize XACIATO clindamycin phosphate vaginal gel, 2%. And the launch is targeted for later this year. The Ovaprene Phase 3 clinical study that we look to initiate in collaboration with the NIH and with advisory support from our commercialization collaborator, Bayer, our Sildenafil cream for female sexual arousal disorder, Phase 2b clinical study, and the two other programs with clinical readouts anticipated this year. However, before we do that in light of the strategic objectives we have already achieved, we're two for two, in terms of entering into commercialization collaboration agreements for our most advanced programs, we want to take a few minutes to clearly articulate the why and the how. Specifically, before providing portfolio and financial updates, I'd like to take a few minutes to review our business strategy and our approach to building value. We started a company because we recognized a few factors about this therapeutic category that are somewhat unique to women's health and together create a compelling opportunity. First, a number of persistent unmet needs in women's health continue to exist. Indications that are not life-threatening, but are life-altering and where therefore products that can improve outcomes and convenience can be compelling. Second, because of her unique biology, we believe that these persistent unmet needs can in many cases be addressed with a well-characterized active pharmaceutical ingredient, or API, delivered in a different way, such as vaginal versus oral or for an indication that has not yet been addressed in women, such as Sildenafil for female sexual arousal disorder. The use of well-characterized APIs is expected to mitigate development risk, time and cost, but by customizing the delivery route for her one can still have a first line or first in category opportunity with a meaningful commercial opportunity. Third, the companies with a robust commercial footprint in women's health often do not have a commensurate internal development effort in women's health. And thus, those companies tend to grow their portfolios through product licenses and acquisition. This gap creates an opportunity for developed focused companies in women's health, as evidenced by the transactions in the category, not just the licensing agreement that Dare has entered into with Organon and Bayer to date, but the other transactions these and other companies with a commercial footprint in women's health have also executed. As a result of these three factors, in the not quite five years since going public, we have assembled a portfolio of one FDA-approved product and seven investigational product candidates or potential product candidates entered into two commercialization collaborations, one with Organon and one with Bayer, and have done so with relatively modest capital deployment and leveraging SBIR NIH grants for four of our programs, an NIH collaborative research agreement for one of our programs and a foundation grant of nearly $50 million for one of our preclinical programs. Creating a diverse pipeline of product candidates that utilize different APIs or different delivery routes and target different indications such that the successful outcome for one product candidate is independent of the outcome of others has been a foundation to our strategy. Our strategy also involves selecting a candidate, both the drug and the delivery vehicle for each indication that represents an opportunity to personalize treatment options for women, both in terms of the unique biology of women and overall convenience for women. Our current portfolio includes drugs delivered via vaginal rings, a viscous hydrogel, a proprietary cream, a soft gel capsule and implant, and an injectable. Our current portfolio also includes numerous programs that utilize those well-characterized APIs and that therefore have been, or that we expect to develop via the FDA's 505(b)(2) regulatory pathway. The 505(b)(2) regulatory path has the potential to shorten the overall development time and cost to obtain a marketing approval in the U.S., as was the case with XACIATO, for which we attained FDA approval just three years after acquiring rights to the program and with just a single pivotal clinical study. We consider many factors when evaluating new product candidates for our portfolio. Since those factors ultimately impact potential funding, including non-dilutive funding for the development of those products, as well as commercialization strategies and opportunities to enter into collaborations such as those that we have already established today with Organon for XACIATO and Bayer for Ovaprene. In terms of process, we start with the persistent unmet needs. We talk to women, advocates, and healthcare providers to identify areas within women's health that have high unmet needs. In some cases, approved therapies for an indication exist, but the therapies are perceived as not sufficiently effective or convenient for the women using them. In other cases, there are no FDA-approved therapies for the indication. Once we identify an area of unmet need, we create a target product profile to address the need. The lens through which we evaluate each potential candidate is that it must have the potential to be a first line or first in category option and to achieve product revenues that would be attractive to a potential commercial collaborator, giving us optionality in terms of how we take the product to market if development is successful. Our portfolio has been built based on the unmet needs we identified and target product profiles we generated and by acquiring or in licensing candidates that we believe have the potential to meet the target product profile, and that demonstrate the characteristics, the features, the outcomes necessary to achieve a first line or first in category product for the indication. Because we seek to leverage well-characterized APIs in many cases, the prospective candidates have proof-of-concept data and are well-positioned for Dare to accelerate their development as we did with XACIATO via our development expertise and our clear commitment to women's health. Most of our current portfolio candidates have been in-licensed or acquired under a financial model designed to allow us to focus our capital on product development and give us flexibility that we need to achieve an accretive commercialization strategy. This model features modest or no upfront cash consideration, milestone payments, if and as candidates successfully advance through development. And if a candidate is ultimately approved, commercial payment obligations are intended to allow Dare to commercialize the product directly or with a commercial collaborator, an approach that defers a large portion of the potential consideration until a program has successfully advanced. And that contemplates potential commercial collaborators has enabled us to assemble a portfolio of eight assets, one FDA approved and seven in development in a cash-efficient manner, and puts us in the position to enter into the collaborations we have to date with Organon and Bayer. When we add a product candidate to our portfolio, we believe we will have the opportunity to launch it ourselves or to collaborate with a third party to fund and execute its commercialization. Ultimately, we select the approach that we believe will provide the greatest access to women and achieve the highest peak sales in the least amount of time because we believe that's best for all stakeholders, women, and our shareholders. Given the stage of our current portfolio and the market dynamics and the therapeutic categories for our most advanced programs XACIATO and Ovaprene, we believe the best avenue to generate value for Dare and its shareholders is via the external commercialization collaborations or out-license agreements, rather than attempting to commercialize these assets on our own. Opportunities to enter into such collaborations are ultimately contingent on developing differentiated products that demonstrate the potential to be first line or first in category. In summary, our business model involves identifying the areas of high unmet needs in women's health, identifying innovative solutions to address such needs, accelerating the innovation through development in a time and cost-efficient manner and executing on a commercialization strategy best suited to create value for our company and our shareholders. To date, we've elected to use our expertise and our funds to advance a portfolio of candidates through late-stage development and in the case of XACIATO, through FDA approval, and to collaborate with larger organizations with established salesforces and greater resources in women's health to conduct the market launch and ongoing commercialization efforts. I'll now turn it over to John for our portfolio update.

Thank you, Sabrina. I will start with bacterial vaginosis and our first FDA approved product XACIATO. Bacterial vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the U.S. The condition results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor and discharge. Organon shares our commitment to advance critically needed innovations in women's health. And we believe that Organon's commercial capabilities will ensure that XACIATO reaches women most impacted by this condition. Through its strong commercial capabilities and expertise in women's health, Organon is in a unique position to bring XACIATO to market and provide women across the U.S. access to this important option. Under our license agreement with Organon to commercialize XACIATO, Dare will receive a $10 million cash payment from Organon upon closing of the transaction and will be eligible to receive potential milestone payments of up to $182 million as well as tiered double-digit royalties based on net sales. Closing of the transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in Q2 of 2022, and XACIATO is expected to be available commercially in the U.S. in Q4 of 2022. Moving onto Ovaprene, our novel hormone-free monthly contraceptive candidate whose U.S. commercial rights are under a license agreement with Bayer, we are targeting commencement this year of what we expect to be the single pivotal study necessary to support a pre-market approval submission to the FDA. In order to initiate the pivotal Phase 3 study, we must have an FDA approved IDE in place. We initiated the IDE process for Ovaprene in early 2022 and pending the FDA's review and approval of the IDE, we seek to initiate the pivotal study in 2022. Based on communications with the FDA in terms of study, sample size and duration, we expect that at least 200 subjects completing 12 months of Ovaprene use will be adequate. Under our CRADA with the Eunice Kennedy Shriver National Institute of Health and Human Development, or NICHD, which is part of the National Institute of Health, NIH, together we are currently preparing for the pivotal Phase 3 study of Ovaprene. Under our license agreement with Bayer to commercialize Ovaprene, Dare has access to Bayer's extensive clinical manufacturing and commercialization resources in advisory capacity for approximately 80 hours per week, while Dare retains full control over Ovaprene's development and regulatory approval process. Bayer has the right to obtain exclusive rights to commercialize Ovaprene in the U.S. following the completion of the pivotal Phase 3 study by making a $20 million payment to Dare. Thereafter, Dare will be entitled to receive commercial milestone payments potentially totaling $310 million in addition to double-digit tiered royalties on net sales. Turning our attention to Sildenafil cream. It's our investigational product to address her version of erectile dysfunction, 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 for which there are currently no FDA approved therapeutics. We continue to enroll women in the Phase 2b RESPOND clinical study evaluating Sildenafil cream as a potential treatment for FSAD at sites across the country. Our study protocol has a planned interim analysis to evaluate power calculations and trial sizing. We expect to conduct that analysis this year after which we will provide guidance on anticipated timing for top-line data from the trial. DARE-HRT1 is our unique intravaginal ring, or IVR, designed to deliver bio-identical estradiol and progesterone continuously over a 28-day period as part of a hormone therapy regimen. We announced positive top-line results from our Phase 1 study of DARE-HRT1 in 2021. And in April of 2022, we announced the start of a new Phase 1/2 clinical study of DARE-HRT1. This open label study will evaluate the PK of lower and higher dose versions of DARE-HRT1, the same two versions evaluated in the first Phase 1 study in roughly 20 healthy postmenopausal women over approximately three consecutive months of use. The study will also collect safety, usability, acceptability, and symptom relief data. This study is being conducted in Australia by our Australian subsidiary to take advantage of the clinical and financial benefits of doing so. We expect to report top-line data from the Phase 1/2 study during the fourth quarter of 2022. And finally, we'll provide a brief update on DARE-VVA1. More than 3.8 million women in the U.S. have a history of breast cancer or are considered survivors. Hormone receptor-positive breast cancer is the most common type of breast cancer diagnosis and the prevalence of vulvar and vaginal atrophy, or VVA, in postmenopausal breast cancer survivors is estimated to be between 42% and 70%. We want to provide an option for these women. 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, as many of these women are not ideal candidates for standard estrogen-based interventions. We initiated a Phase 1/2 clinical study in Australia in the third quarter of 2021 for this breast cancer survivorship vaginal atrophy treatment program, and we expect to report top-line data from the DARE-VVA1 Phase 1/2 study during the second half of 2022. Thus, in terms of anticipated milestones for 2022, we look forward to keeping you updated on one product launch, which we're extremely excited about, one pivotal Phase 3 study start, which we are also very excited about, and two data readouts. And with that, I will now turn the call over to Lisa.

Thank you, John. And thanks to all of you for joining us today. I would now like to summarize Dare's financial results for the quarter ended March 31, 2022, which I will refer to as the current quarter or the first quarter of 2022. As you know, Dare'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. While our general and administrative expenses, or G&A, tend to be somewhat predictable throughout the year, our R&D expenses will vary with our clinical, preclinical, manufacturing, regulatory and other activities related to advancing our portfolio of candidates. So for the first quarter of 2022, our G&A expenses were approximately $2.6 million and our R&D expenses were approximately $5.8 million. The current quarter's R&D expenses were approximately 1% greater than the same period in 2021, and they primarily reflect the costs and activities related to the ongoing Sildenafil cream Phase 2b RESPOND clinical study and manufacturing and regulatory activities related to Ovaprene. Our comprehensive loss for the current quarter was approximately $8.4 million. We ended March 31, 2022 with approximately $39.3 million in cash and cash equivalents. Subsequent to the end of the quarter, so from April 1 through May 10, we received approximately $1.2 million in net proceeds from additional sales of stock under our ATM. In addition, as John just mentioned, Dare will receive a $10 million cash payment from Organon upon the closing of the transaction under the license agreement for XACIATO, which we currently expect to occur in this quarter. In addition, Dare will be entitled to receive a cash payment of $2.5 million upon the first commercial sale of XACIATO in the U.S., as well as potential future milestone payments of up to $180 million and tiered double-digit royalties based on net sales. XACIATO is expected to become available commercially in the U.S. in the fourth quarter of 2022. As of May 10, Dare had approximately 84.7 million shares of common stock outstanding. In closing, as we have said before, 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 investors to review the more detailed discussion of our financials and financial condition, our liquidity and capital resources, and our risk factors in our Form 10-Q for the quarter ended March 31, 2022, which was filed this afternoon, so today, as well as our annual report on Form 10-K for the year ended December 31, 2021, which was filed on March 31, 2022. I would now like to turn the call over to our operator, so Delfin, take it away.

Thank you, Lisa. Thank you for attending the conference call. We will now conduct the question-and-answer session. Our first question is from Zegbah Jallah of ROTH Capital Partners. Please go ahead.

Hello. Thanks for taking my questions and thanks for really the thorough background on the company and the strategy. So, the first one for me here is just about XACIATO. As part of the commercial launch plans, can you kind of update us on where you are with the manufacturing process?

Yeah, definitely. And thanks for the questions and thanks for being on the call and for your comments. Yeah. So, as we had guided previously, manufacturing activities to support the commercial launch are definitely underway. And as we had anticipated, those commercial supplies would be available at the earliest in the summer timeframe. And so based on that, that's where the timing for the launch that we're working on in collaboration with Organon is in the fourth quarter. That's where that is aligned with. So, we are working closely with Organon on that as they prepare for the launch later this year. And to support that obviously, we expect the transaction to close in the second quarter.

Thanks Sabrina. And then, the follow-up here is just for Ovaprene regarding next steps. Can you please clarify what those are? And then, I know John commented on the sample size that might be necessary. And just wanted to confirm if the FDA had okayed or you guys are still waiting to discuss those.

Thank you for your questions about Ovaprene. The IDE process with the FDA differs from the IND process that many are familiar with. For Ovaprene, the IDE process is partly based on our pre-pivotal study results, which led to our collaboration with Bayer. This occurred before we entered the IDE phase. Additionally, the IDE process includes what's known as pre-submission, allowing for collaborative discussions with the FDA to clarify questions and ensure that the IDE is properly structured to support approval. This helps us gather the necessary information for a pivotal study that meets their PMA expectations. We began this process earlier this year. Regarding the pivotal study size, the feedback indicates an expectation of around 200 subjects over a 12-month period, corresponding to 13 cycles. This information is based on our discussions with the FDA about the pivotal study requirements. Starting the IDE process early, along with our collaborations with the NIH and Bayer, facilitates communication with the FDA. It also allows us to incorporate feedback from both collaborators for successful study conduct and commercialization. As we prepare for the pivotal study in conjunction with the NIH, we are excited about their experience and support. We anticipate providing further updates on the timing of the pivotal study start later this year. This background gives perspective on our interactions with the FDA and the design of the pivotal study, which is essential for us to move forward effectively, including ensuring manufacturing supply and site readiness for execution.

Perfect. Thanks Sabrina. Then the last one here, with the market the way it is, folks are really checking on cash balances and spend. And with a Phase 3 study coming up, a lot of folks are kind of curious about what the financial obligation might be. And I know, as part of the NIH agreement, the CRADA agreement, they could help offset some of those costs. And so, we just wonder if you can put into clear terms as to what your financial obligation might be as it relates to the Phase 3 Ovaprene study? And then thanks again for taking my questions.

Absolutely. Thank you for that. This is something that all companies are closely monitoring in the current market. We are fortunate to have strong collaborations and manageable infrastructure and capital requirements, especially in the context of our sector. To give some perspective, our general and administrative expenses were $2.6 million for the quarter, while it was $2.5 million for the prior quarter, indicating that our fixed cost G&A is around $10 million for the year. This is quite manageable, especially considering our cash balance of nearly $40 million for the quarter. Importantly, as you mentioned regarding Ovaprene, we have worked hard to secure non-dilutive funding where it strategically benefits our portfolio. This gives us substantial flexibility and positions us well in the current market. Additionally, having an FDA-approved product that Organon can launch is reassuring. For Ovaprene specifically, we have entered into a collaboration with the NIH, which shares the costs of the pivotal study. Dare's share of the clinical study costs is $5.5 million, with $5 million already paid to the NIH. These funds are part of the preparations for the trial this year, ensuring necessary resources are available for startup activities such as working with sites and finalizing protocols. We have plenty of flexibility with our cash burn and while we are advancing our portfolio of programs, the capital required to achieve our milestones is well within reach. The pivotal studies and two data readouts this year are being conducted in our subsidiary in Australia, which helps minimize expenses. We are well-positioned for all these initiatives and are grateful for your great question and sensitivity to these aspects.

Thank you. And our next question is with Douglas Tsao from H.C. Wainwright. Please go ahead, sir.

Good afternoon. Thanks for taking the questions. Sabrina, I'm just curious, you've referenced having access to the NIH network for executing the Ovaprene study. I'm just curious from an operational standpoint, how much do you think that will ultimately accelerate your enrollment versus what you would have maybe done on a standalone basis or without it?

Thank you for the question, which is very timely. We just had a series of productive meetings that emphasize why collaborations like ours extend beyond financial benefits. At the recent ACOG conference, we had a great opportunity to connect with our collaborators. Partnering with the NIH is particularly valuable because their group managing contraceptive clinical trials is involved in numerous trials specifically related to contraception. This means they participate in more trials than we could individually, which provides us insights from a broad range of organizations and funding sources. The NIH can share important insights that individual collaborators might not be able to. This collaboration has given us operational strategies and information that enhance our effectiveness. For instance, they've provided insights into enrollment and dropout rates, helping us understand expectations at various trial sites. While they don't share proprietary information, their broader perspective has been crucial for guiding our strategy. Overall, these insights have been very beneficial, and if we were working independently with those sites, we wouldn't have access to such valuable information.

And then just another question, if I may. A little bit of a follow-up maybe to the prior question just around the broader capital markets. You obviously have a number of product candidates even beyond sort of what you would have thought. A year ago, we'd have thought of you should have lead assets and you have a number sort of right behind them. Does the current situation affect sort of how you evaluate data? Does it make you more conservative about what you might see? Does that mean that some programs might have a higher hurdle than perhaps in a three-year capital environment to advance? And I am not sure if that makes sense.

Yeah. It absolutely does make sense. And I would say one of the things that we have always tried to do from day one is be thoughtful and capital efficient. And what that means, that doesn't mean literally be inexpensive. What that means is doing exactly what you're talking about every day, right? Every day is a new day, looking at the information in hand real-time, right? What is the best way to deploy capital today? Does this program still stand up? Is this program still truly differentiated? Are these data supportive of that? Are we going to be able to secure a commercialization strategy that is truly accretive for this product? Where does it stand in the competitive landscape? Is it still holding up? So, we do that real-time. And we've navigated challenging times before, where we had to make decisions around which programs to push after, which programs to go slower, whether it was based on new information we wanted to generate or based on the environment. I mean, I go back to COVID 2020, and that seems like 100 years ago now. But when that year started, we weren't flushed with capital. We had to make decisions of what to do with the capital that we had in the best way to create shareholder value. And we decided to move quickly with our XACIATO program and go ahead and execute effectively on that Phase 3 trial. We also decided that it makes sense to move quickly on our HRT1 program and generate that Phase 1 data because for a program like that, Phase 1 data is proof-of-concept that you have ultimately a product that can advance and we paused that year. You may remember, we didn't think that was the right year to start the Sildenafil Phase 2b. We had reached alignment with the FDA on what that program would take, but we were worried about starting that trial in such an uncertain COVID environment. So, we've had to do this real-time. And the beauty of having the kind of portfolio that we have is that we have that ability to pivot, in ways that a company maybe without as rich of a portfolio might be a little more constrained to do. We have an opportunity to pivot, to deploy capital in a way where we can still be advancing things, we can still be creating value, but doing it responsibly with the capital on hand and doing it responsibly without having to take measures that maybe aren't as favorable for our shareholders, but still creating value. And the other leg of that is playing against our assets; non-dilutive funding whenever we can. We have now received grants for four different programs from the NIH. We have a foundation grant of almost $50 million. Those grants are primarily directed at our preclinical programs and to help advance those programs with the exception of Ovaprene, where the NIH funded our external cost of our pre-pivotal study, and we have the NIH collaboration for Ovaprene. So, Doug, we look at it every way. We look at it at prioritizing the capital responsibly against programs in a particular environment that we think are best suited to create value in that environment. We look at the opportunity for grants. And then sometimes, yes, we look at potentially not pedal to the metal, but not as fast as we maybe could have in a different environment, and we have the flexibility to execute against all three of those tools.

Thanks for taking my question. So, one more on Ovaprene. Where are you in terms of this pre-submission collaboration? Are we getting closer to the end of that, and you guys are ready to move forward with the IDE filing? And once the IDE is cleared, how quickly are you able to start the clinical trials?

The IDE process is moving forward. We usually don't share many specifics about our interactions with the FDA, but it's important to note that we are engaged in a process that aligns with our plans to initiate the pivotal study. This process is coordinated with our discussions with the NIH and the sites, and it sets the timeline for when we plan to start. The more intensive enrollment activities will only begin once the IDE is approved. Our timeline with the FDA is aligned with this goal. One of our primary objectives in starting the process with the FDA was to seek their input on the pivotal protocol, ensuring that our approach meets their expectations for a pivotal study that supports a future PMA. This clarity on the protocol is essential for us to begin our collaborative efforts with the NIH and the collaborating sites. We are already in discussions with the sites and the NIH to prepare for the study. While we will provide more specifics later this year, we are on track to support the start of the pivotal study this year.

Okay. And with regard to XACIATO pre-commercialization activities, like payer interaction, thinking about pricing, is Organon taking care of all of those or how much involvement are you guys having right now with regard to that?

Under our agreement with Organon, they are responsible for all these activities. The benefit of partnering with Organon lies in their expertise and capabilities. I can confidently say that both of our collaborations with Organon and Bayer are excellent; they appreciate what Dare contributes. They value our insights and input, allowing us to have a significant role in discussions about commercialization strategies. Ultimately, Organon is set to execute the plan for XACIATO, which is why we chose them for their capabilities. Their collaborative approach is truly impressive. Our partnership with Bayer similarly allows Dare to provide insights and expertise gained from closely working on the product without being a financial participant in the process.

And one more on the recent grant from NICHD for this work on long-acting injectable hormonal contraception.

Yeah. Great question. So, as I mentioned, and a couple of us touched on there a few times today, grant funding is really useful, as a wonderful tool to allow us to continue to advance, particularly our preclinical programs, right? Those are great dollars, non-dilutive dollars to be able to put against that. And this particular grant from the NIH, so it's actually our third contraceptive program to get a grant from the NIH, we received NIH SBIR grant for Ovaprene and our DARE-LARC1 implant, and this is for the ADARE injectable contraceptive that we have in preclinical development. It's being developed as the opportunity to deliver a six-month or a 12-month hormonal contraceptive via just one or two injections per year, whether it's a six-month or a 12-month. And this particular grant was to really get more insights as we're preparing. It's in preclinical stages now, but we're always trying to gear up and get ready to move into Phase 1 and beyond. This particular grant is to make sure we're really clear on understanding user preferences, where an innovation like this will fall in the method mix, the women most likely to be interested in it and also, like the duration of the contraceptive action is 12 months really needed; is six months sufficient so that we can make sure that we are designing a Phase 1 program and beyond as this program is getting advanced to, that really is going to be differentiated and commercially strong. And going back to all the points I made upfront in the opening comments, making sure that it's positioned well as a differentiated product that gives us a lot of optionality around commercialization collaboration. So, this is intended to gather some of that data from a market perspective that can be very, very, very helpful and influential in those discussions, and we're getting ready to go right away.

Great. Thanks so much.

Awesome. Thank you.

Thank you. There are no more questions on the queue. And with that, I will turn the call over back to Ms. Johnson for the closing remarks.

Great. Well, thank you all for taking the time this afternoon to hear about our recent updates and our ongoing commitment to drive value for all of Dare's stakeholders: the women, the healthcare providers, and our shareholders. With our diverse portfolio, we seek to bring to market differentiated prescription therapies that prioritize women's health and wellbeing, expand treatment options and improve outcomes, primarily in the areas of contraception, fertility, vaginal and sexual health. And today, as we've discussed, we have seven candidates in various stages of development and one FDA approved product expected to launch commercially in the fourth quarter of this year. We sincerely look forward to keeping you updated on our progress against the important 2022 objectives and milestones we set for our candidates under development, as well as activities with Organon that we've been discussing regarding the XACIATO launch. So, thank you for taking the time this afternoon. We look forward to keeping you updated.

And this concludes today's conference call. Thank you everyone for your participation. You may now all disconnect.