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spk06: Welcome to the conference call hosted by DeRay Bioscience to review the company's financial results for the quarter ended March 31, 2022, and to provide a general business update. This call is being recorded. My name is Delphine, and I will be your operator. With us today are Ms. Sabrina Mertuti-Johnson, DeRay's President and Chief Executive Officer. Mr. John Fair, the RAISE Chief Strategy Officer, and Ms. Lisa Walters-Hofford, the RAISE Chief Financial Officer. Ms. Johnson, please proceed.
spk02: Thank you. Good afternoon and welcome to our first quarter of 2022 Financial Results and Business Update call for DARI Bioscience. Our plan today is to review our first quarter results, discuss development since our last call in March, and use the time to review our business strategy and highlight our objectives and milestones anticipated for 2022. Before I 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 facts 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 31st, 2021, which is filed on March 31st, 2022. I'd 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. DARI 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, DARI is solely and squarely focused in women's health. It's 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 will provide an update on the collaboration with Organon to commercialize Zosciato, clindamycin phosphate vaginal gel, 2%, and the launch targeted for later this year. The oviprene phase 3 clinical study that we look to initiate in collaboration with the NIH and with advisory support from our commercialization collaborator, Bayer, our Sidenafil Cream 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 the 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 Sidenafil for female sexual arousal disorder. 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 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 the 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 drug delivered via vaginal rings, a viscous hydrogel, a proprietary cream, a soft gel capsule, an 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 505B2 regulatory pathway. The 505B2 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 Zasciato, 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 to date with Organon for Zasciato and Bayer for Obaprene. In terms of process, we start with the persistent unmet need. 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 thus 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 DARI to accelerate their development as we did with Zasciato 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 to 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 put 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, Zasciato and Oviprene, 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 Zasciato's case, through FDA approval, and to collaborate with larger organizations with established sales forces 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 updates.
spk05: Thank you, Sabrina. I will start with bacterial vaginosis and our first FDA-approved product, Zasciato. 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 Zasciato 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 Zasciato to market and provide women across the US access to this important option. Under our license agreement with Organon to commercialize Zasciato, 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 Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in Q2 of 2022, and Zasciato is expected to be available commercially in the U.S. in Q4 of 2022. Moving on to OverPrint, our novel hormone-free monthly contraceptive candidate whose U.S. commercial rights are under a licensed agreement with Bayer, we are targeting commencement this year of what we expect to be the single pivotal study necessary to support a premarket approval submission to the FDA. In order to initiate the pivotal phase three study, we must have an FDA-approved IDE in place. We initiated the IDE process for oviprene 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 oviprene 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 Institutes of Health, NIH, together we are currently preparing for the pivotal phase three study of oviprene. Under our license agreement with Bayer to commercialize oviprene, DARE has access to Bayer's extensive clinical manufacturing and commercialization resources in an advisory capacity for approximately 80 hours per week, while DARE retains full control over oviprene's development and regulatory approval process. Bayer has the right to obtain exclusive rights to commercialize oviprene in the U.S. following the completion of the pivotal Phase III 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 IIb 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. DER-HRT1 is our unique intravaginal ring, or IVR, designed to deliver bioidentical 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 VVA-1. 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 vulval and vaginal atrophy, or VVA, in postmenopausal breast cancer survivors is estimated to be between 42% and 70%. We would like 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 of or at risk for hormone receptor-positive Brent's 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 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 three study start, which we're also very excited about, and two data readouts. And with that, I will now turn the call over to Lisa.
spk01: Thank you, John, and thanks to all of you for joining us today. I would now like to summarize DARI's financial results for the quarter ended March 31st, 2022, which I will refer to as the current quarter or the first quarter of 2022. As you know, DARI's business model is to assemble, advance, and monetize a portfolio of novel product candidates in women's health. As a result, our expenses consist of corporate overhead, portfolio acquisition and maintenance costs, and research and development, or R&D, activities. While our general 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 Overpre. Our comprehensive loss for the current quarter was approximately $8.4 million. We ended March 31st, 2022 with approximately $39.3 million in cash and cash equivalents. Subsequent to the end of the quarter, so from April 1st through May 10th, we received approximately $1.2 million in net proceeds from additional sales of stock under our ATM. In addition, as John just mentioned, JARE will receive a $10 million cash payment from Organon upon the closing of the transaction under the license agreement for Zasciato, which we currently expect to occur in this quarter. In addition, JARE will be entitled to receive a cash payment of $2.5 million upon the first commercial sale of Zasciato 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. Zasciato is expected to become available commercially in the U.S. in the fourth quarter of 2022. As of May 10th, Dari 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 values. 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 31st, 2022, which was filed this afternoon, so today, as well as our annual report on Form 10-K for the year ended December 31st, 2021, which was filed on March 31st of 2022. I would now like to turn the call over to our operators. So, Delphin, take it away.
spk06: Thank you, Lisa. Thank you for attending the conference call. We will now conduct a question and answer session. Everyone, to ask a question, you will need to press star 1 on your telephone keypad. Once again, press star 1. Our first question is from Zigbir Jalla of Broad Capital Partners. Please go ahead.
spk03: 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 Zosciato. As part of the commercial launch plans, can you kind of update us on where you are with the manufacturing process?
spk02: Yeah, definitely. And thanks for the questions and thanks for being on the call and for your comments. Yes. So as we had guided previously, so manufacturing activities to support the commercial launch are definitely underway. And as we had anticipated, those commercial supplies would be available, you know, 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 a 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, you know, we expect the transaction to close in the second quarter.
spk03: Thanks, Sabrina. And then the follow-up here is just for Obra Prene regarding next steps. Can you please clarify what those are? And then I know John commented on the sample size that might be necessary for And I just wanted to confirm if the FDA had okayed or you guys are still waiting to discuss those.
spk02: Yeah, great questions about oviprene. And so the IDE process with the FDA is a little bit different than what many of us are accustomed to with an IND process. So, for instance, in the case of oviprene, the IDE process is actually in part predicated on the pre-pivotal study that we did and the outcome of that study, which led to our collaboration with Bayer. So that actually all happened before you even get to the IDE phase. And then an IDE process, they allow the IDE process to include what's called pre-submission, IDE pre-submissions, so that you can actually have collaborative discussions with the FDA to address questions and to make sure that ultimately your IDE is really set up to support the IDE approval and that you have all the information that you need to to be successful to transitioning to a pivotal study that is going to meet their expectations for a PMA. And so that's the process that we initiated earlier this year. And so to your question, therefore, on the size of the pivotal study, yeah, the feedback that John shared in terms of that expectation around 200 subjects out to the 12-month time point, which is basically 13 cycles, 13 menstrual cycles. Women have more than one cycle, it turns out, per month. If you add them all up in a year, so it's 13 cycles. That is based on the discussions with the FDA and their communication expectations for the pivotal study. And so what's so important about us starting the process the way we did with the IDE is, as John also mentioned, we have a collaboration with the NIH, as well as with Bayer. And so starting this discussion process as part of the whole IDE, ultimately IDE approval process, and getting some clarification on both input we wanted to share with the FDA about what we'd like to be doing in the pivotal study based significantly on feedback from Bayer to support ultimate commercialization and from the NIH to support successful conduct. It allows us to have that discussion with the FDA. And then go back to our collaborators, Bayer and the NIH, so that as we're planning that pivotal study that we're going to be running in collaboration with the NIH, it allows us to really do a lot of work in preparation earlier than one might otherwise normally be able to start in terms of starting now to identify sites and speak with sites and ensure that they're going to be interested in the study and ensure that they're going to be able to execute against the study. And we're really excited to be working with the NIH and their clinical trial contraceptive network because of the experience that they have. So we look forward to giving more updates as this process proceeds and as we can give some more clarity on timing of the pivotal study start that we're targeting this year. But that hopefully gives a little more perspective on the background, the process with the FDA, And then importantly on, you know, the pivotal study design, kind of that big picture of design, which is really critical for us to understand as quickly as we could because that also, as you can appreciate, obviously feeds into just making sure we have manufacturing supply and, you know, and all the sites set up to really execute against a successful study.
spk03: Perfect. Thanks, Sabrina. And then the last one here, you know, with the market the way it is, folks are really you know, checking on cash balances and spend. And with the phase three study coming up, a lot of folks are kind of curious about, you know, what that financial obligation might be. And I know, you know, as part of the NIH agreement, the crowd agreement, you know, they could help offset some of those costs. And so we just wonder if you can put into, you know, clear terms as to, you know, what your financial obligation might be as it relates to the phase three overprint study. And then thanks again for taking my questions.
spk02: Absolutely. Thank you for that. So obviously, right, this is something that I think all companies in today's market landscape are paying close attention to. And honestly, it's markets like these where, you know, we're grateful to have the kind of collaborations that we have and to have, frankly, the kind of infrastructure and capital requirements that we have, which are really, really, really manageable in the context of the sector in general. So I'll start first with just, as Lisa mentioned, just to give some perspective. GNA, $2.6 million for the quarter, $2.5 million for the quarter. So that gives you some perspective. Our fixed cost GNA is about $10 million for the year, right? So very manageable, particularly given our cash balance that Lisa talked about, the almost $40 million for the quarter, and then on top of that, the monies that are expected to come in just from the closing and the first commercial sale under Zasciato. But in addition to that, importantly, is what you touched on in terms of the question around oviprene. Part of what we have also really worked hard to do is to secure non-dilutive funding wherever it strategically makes sense for the portfolio, and that also creates a situation where our cash balances and the cash we have on hand, you know, just gives us a lot of flexibility and puts us in a position to endure the kind of market that we are all dealing with right now, and not to mention, you know, obviously having an FDA-approved product that, you know, has the ability to launch feels good, too. So specifically for oviprene, we entered into a collaboration with the NIH, which has us sharing the cost. of that pivotal study. And importantly, DARE's portion of the conduct cost of the clinical study is $5.5 million, five of which has already been paid, basically, to the NIH, right? So those funds have already gone to the NIH because that's part of preparing for the trial. commencement this year is ensuring that those resources are in, but it's essentially like an escrow account so that they can start utilizing the resources for the various startup activities that I talked about, like working with the sites, finalizing the protocol, all of that good stuff. So, you know, we have a lot of flexibility with our burn. We have a portfolio of programs that, yes, on the one hand we're advancing, but on the other hand the capital required to do so and hit the milestones that we've been talking about this year, the Pivotal Study Start, the two data readouts we have this year, both of which are being conducted in a subsidiary in Australia, which minimizes expenses as best you can for Phase 1 because the overall costs are lower. We're really well positioned for all of that and beyond. So thank you for asking. Great question. And we definitely appreciate the sensitivity to that.
spk06: Thank you. And our next question is with Douglas Tsao from H.C. Wainwright. Please go ahead, sir.
spk04: Good afternoon. Thanks for taking the questions. Sabrina, just curious, you referenced having access to the NIH network for executing the overprint study. I'm just curious, from an operational standpoint, how much do you think that will impact ultimately accelerate your enrollment versus what you would have maybe done on a standalone basis or without it?
spk02: Yeah, thank you. I like that question, and it's timely because we just had a lot of great meetings that kind of drive home why collaborations like this are more than just the money that they bring to the table. Because it was the ACOG conference last week, the American College of and gynecologists, and so it was a nice opportunity to connect with some of our collaborators. And the value of collaborating with the NIH on something like that is that the NIH, and particularly their group that does these and their contraceptive clinical trials network, is a group that participates in a number of clinical trials. in contraception specifically, frankly, more than DARE or even our partner like Bayer, right, more than we as individual companies would be doing on our own because they get to see trials across different organizations and different funding institutions. And then having that coordinated through the NIH in a way that an individual collaborator would not be able to share certain insights with us, you know, from an NIH perspective, there are insights that big picture the NIH can share. So what it's really allowed us to do is have information and insights around operational strategy for the trial that as effective as DARI can be, and I think we've shown that we can be very effective with our execution on the Zasciato phase three trial in 2020 during COVID, We can certainly be effective and navigate those things, but having that kind of insight is helpful. So, for instance, they've been able to talk with us around enrollment rates and dropout rates and give us a sense of, at a site level and at a high level, what they've seen across different trials. in terms of expectations. Nothing proprietary. They don't share anything inappropriate with us, but they're able to have that big picture perspective to guide our strategies. So all of that has been really helpful. And to your point, Doug, it's insights that if we were operating individually with those sites, we wouldn't have at the same level.
spk04: And then just another question, if I might. a little bit of a follow-up maybe to the prior question just around the broader capital markets. And, you know, you obviously have a number of product candidates, even beyond, you know, sort of what you would have thought a year ago, we would have thought of your sort of 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 freer capital environment to advance? And I'm not sure if that makes sense.
spk02: 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. Every day is a new day, looking at the information in hand real time. What is the best way to deploy my 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? We do that real time. We've navigated challenging times before where we had to make decisions around which programs to push faster, which programs to 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 flush 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 Zasciato program and go ahead and execute effectively on that phase three trial. We also decided that it makes sense to move quickly on our HRT1 program and generate that phase one data because for a program like that, phase one 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 Sidenafil 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, you know, 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 deploying against our assets non-dilutive funding whenever we can. We have now received four different – we have received grants for four different programs now 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 oviprene where the NIH funded our external cost of our pre-pivotal study. And we have the NIH collaboration for oviprene. You know, Doug, we look at it every way. We look at it at prioritizing the capital responsibly against the 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, you know, 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.
spk04: Okay, great. Thank you so much. That's super helpful.
spk02: Yes.
spk06: Thank you. And our next question is with Kumar Raja, Brookline Capital Markets. Please go ahead, sir.
spk07: Thanks for taking my question. So one more on OOPRIN. 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?
spk02: Yeah, great question. So in terms of the IDE process, that process is proceeding. We don't typically give too much detail about our discussions, ongoing discussions with the FDA. Other than to say what matters about the process is that we've been working with the FDA and on a process that really aligns with the second part of your question, our plans to commence the pivotal study. And so that process is very much aligned with when we have been talking with the NIH and with the sites and just the plans on when we'd like to commence the more serious obviously enrollment activities that you can't commence until the ID is approved. So the timeline that we have been working with and with the FDA on is very much aligned with that. And in terms of that, one of the reasons that we wanted to start the process with the FDA and have as our first item on the list getting input from the FDA on the pivotal protocol and making sure that what we were planning was aligned with their expectations for a pivotal study that would support an ultimate PMA was so that, to your point, we could start doing work now, you know, with the NIH, with the collaborator sites to you know, with that clarity on the protocol that you can't do without that clarity on the protocol. So we've already been talking with the sites and talking with the NIH and working with them, you know, collaboratively to get ready for the study, but in terms of specifics, you know, we'll have more to guide on later this year, but it's on target to support that pivotal study start this year.
spk07: Okay. And with regard to Xasiato, 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?
spk02: Yes, so under our agreement with Organon, they're responsible for all those things. Those are all activities that Organon will deploy against, and that's the value of having an Organon as a partner is their expertise and their capabilities there. I can say this quite comfortably about both of our collaborations with Organon and with Bayer. These are wonderful collaborators. They really value what DARI brings to the table. They value our insights and our input, and we get to have a nice participating seat at the table around these commercialization strategies and discussions and things like that. Ultimately, Organon will execute it. It's Organon's plan to execute Anzacchiato, and we want it to be Organon's plan to execute because that's why we picked them, was for that ability. But it's really wonderful how truly collaborative they are, and our partnership with Bayer is also in terms of, you know, really allowing Dare to be not a financial participant in the process, because we're going to uncover all of that, but to have a seat at the table to give our insights and expertise that we've gained working so closely on the product.
spk07: And one more on the recent grant from NICHD for this work on long-acting injectable hormonal contraception. So what is the timeline in terms of when this gets funded? And when do you think you will have data from these studies?
spk02: Yeah, great question. So as I mentioned, you know, and a couple of us touched on, you know, 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? We're 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 grants for oviprene and our DER-LARC1 implant, and this is for the DER 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 some 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 one 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, you know, be interested in it, and also, like, the duration of the contraceptive action, you know, is 12 months really needed, is six months sufficient, so that we can make sure that we're designing a phase one program and beyond as this program is getting developed. you know, advance to that, that really is going to be differentiated commercially strong. And going back to all the points I made up front 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.
spk07: Great. Thanks so much.
spk02: Awesome. Thank you.
spk06: 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.
spk02: 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 DARI's stakeholders, the women, the health care providers, and our shareholders. With our diverse portfolio, we seek to bring to market differentiated prescription therapies that prioritize women's health and well-being, 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 22 objectives and milestones we've set for our candidates under development, as well as activities with Organon that we've been discussing regarding the Zosciato launch. So thank you for taking the time this afternoon. We look forward to keeping you updated.
spk06: And this includes today's conference call. Thank you, everyone, for your participation. You may now all disconnect.
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