Q1 2025 Dare Bioscience Inc Earnings Call
Gail: Welcome to the conference called hosted by Dare Bioscience to review the company's first quarter, 2025 financial results and to provide a business update. This call is being recorded. My name is Gail and I will be your operator today. With us today from Dare are Sabrina Martucci Johnson, President and Chief Executive Officer and MarDee Haring Layton, Chief Accounting Officer. Miss Haring Layton, please proceed.
Gail: Good afternoon and welcome to the Dare Bioscience Financial Result and Business Update call for the quarter ended March 31st, 2025.
Speaker Change: Today, we will review our results, discuss developments and expectations for our pipeline and portfolio, and discuss our recently announced expanded business strategy, leveraging a dual-pass strategy where we commercialize our proprietary formulations via 503B compounding.
Speaker Change: while continuing to seek FDA approval, as well as taking steps toward launching certain solutions as branded consumer health products that do not require prescription, in all cases to bring solutions to market as soon as practicable.
Speaker Change: I would like to remind you that today's discussion will include for looking statements within the Meaning of Federal Security blobs, which are made pursuant to the safe part of provisions of the private security litigation reform act of 1995.
Speaker Change: Any statements made during this call that are not statements an historical fact should be considered for looking statements?
Speaker Change: Actual results for 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.
Speaker Change: or looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our form 10Q for the quarter ended March 31st, 2025, which was filed today and our form 10K for the year ended December 31st, 2024.
Speaker Change: I would also like to point out that the content of this call includes time-sensitive information that is currently only as of today, May 13, 2025.
Speaker Change: Darae undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except it's required by law. I will now turn it over to Sabrina.
Sabrina Martucci-Johnson: Thank you and thank you everyone for joining the call today. We are excited to announce today that in addition to our proprietary Sedentifil Cream Formulation
Sabrina Martucci-Johnson: We are taking action to make three more solutions for women available commercially to regional probiotics in 2025 and are proprietary monthly hormones therapy in 2026.
Sabrina Martucci-Johnson: Making our form on therapy solutions available next year creates a commercial opportunity to daughter in the estimated $24.5 billion compounded form on therapy markets and enables women to have access to an evidence-based solution.
Sabrina Martucci-Johnson: As you can appreciate, four on-market products will exploit revenue generation and provide a past possibility. We expect to start recording revenue in the fourth quarter of this year.
Speaker Change: Everyone following the healthcare and biotech sectors knows that the first quarter of 2025 has been marked by distractions and disruptions for the overall healthcare and biotech sector.
Speaker Change: I'm proud that Dari's uniquely positioned to cut the noise and deliver value to all of our shareholders, women, health care providers, and investors who are all stakeholders in Dari.
Speaker Change: Today, Biopharmaceutical companies with relatively low risk assets, a competitive advantage, and a path toward near-term revenue are positioned to offer upside. We believe that is Dari today.
Speaker Change: Women's health is ripe for returns because it has been underfunded and fragmented.
Speaker Change: and with our recently announced expanded business strategy, we believe we are strongly positioned to deliver value and returns to all of our stakeholders with a business model that is nimble, allowing us to rapidly commercialize multiple products via multiple channels.
Speaker Change: We're no longer only seeking S.A.A. Global, we're leveraging a new type of strategy where we commercialize the S.A.S. to be compoundings while continuing to seek S.A.A. Global. We're also taking the next ones, launching certain solutions as branded consumer health products that do not require exception.
Speaker Change: at Johnnie Women's Health Center for Priority, it's a sole purpose and to acknowledge we are the only publicly traded company, so because solely on developing Serbian sex, it's a very broad range of conditions affecting women.
Speaker Change: Conception, Sexual Health, Health and Pain, Fertility, Infectious Disease, Sexual Health and Menopause.
Speaker Change: This technology is the only publicly traded company leveraging all available paths between essence-based solutions to market, reflecting where and how women are getting and paying for their share.
Speaker Change: As an FDA approved treatment, as a compounded product, as a consumer health product, it does not require prescription available via the health, online or the individual person visit with her health care provider.
Speaker Change: Our portfolio is compelling. And over the last months and the next months, we look forward to continuing to provide updates regarding strategic partnerships and collaborations to facilitate access to DRA on market brands for women across multiple channels.
Speaker Change: Today, I'll provide some perspective on these panels and the strategic relationships we're seeking to enter into to provide women with access to our evidence-based solutions from their trusted sources, where they get their medication and their healthcare solutions.
Speaker Change: I'll also provide a refresher on our potential first in category monthly and traditional hormone therapy. I probably can that we've been developing to really shift the hormone therapy landscape.
Speaker Change: Gap solutions for menopause symptoms have been rise to an explosion of untested supplements and therapies. We believe in delivering hormone therapy that has been rigorously studied to meet the needs of women and their doctors.
Speaker Change: Please keep in mind that bringing our proprietary Sidenitville cream formulation and our monthly international hormone therapy solution to market VF503B compounding will not impact the regulatory process or commercial opportunity for an FDA-approved product.
Speaker Change: Rather, if successful, it accelerates the availability of these proprietary formulations for healthcare providers and women, and it accelerates revenue.
I'll also give some background on the vaginal probiotics that we also intend to bring to market this year.
Speaker Change: Both of which, by the way, were identified via a grant we received from the Gates Foundation to evaluate the global probiotic manufacturer community and identify evidence-based formulation for manufacturer's following GMP.
Speaker Change: I'll also give a brief update on Overtrain, our novel investigational, hormone-free, monthly international contraceptive, the ongoing enrollment in the Pivotal Phase III contraceptive Advocacy Study, and our Data Safety Monitoring Board Interim Assessment, which is scheduled for July of this year.
Speaker Change: As well as other fair pedic development pipeline updates on Sydenafil and Dare HPV, which is our investigational product for the treatment of human patholoma virus infection, which is the virus that causes cervical cancer.
Speaker Change: Before I provide additional updates, I'm going to first turn it back over to our Chief Accounting Officer, MarDee, to review the first quarter of 2025 financial results.
Mardee Haring-Leighton: Thanks, Sabrina, and thanks everyone for joining us today. I would now like to summarize our financial results for the quarter-ended March 31st, 2025, which I will refer to as the first quarter.
Mardee Haring-Leighton: This is where Dari's business strategy is to assemble an advance of portfolio of differentiated treatment solutions that address meaningful unmet needs. We've identified in women's health and then to monetize the value of our portfolio's clinical and regulatory advances over the near and long-term.
Mardee Haring-Leighton: The investment required to build an example portfolio includes corporate overhead, portfolio, acquisition and maintenance costs, and ongoing research and development, or R&D expenses.
Mardee Haring-Leighton: During the first quarter of 2025, our general and administrative expenses were approximately 2.3 million, which is a 14% decrease compared to Q1 2024 due primarily to reduce stock-based compensation expense, reduce professional services expense, and reduce head count.
Mardee Haring-Leighton: We continue to maintain a lean and focus team and our managing overhead costs closely.
Mardee Haring-Leighton: Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory and other development program costs, were approximately 2.3 million, which is a 31% decrease compared to Q1 2024.
Mardee Haring-Leighton: Our comprehensive loss for the quarter was approximately $4.4 million. We ended the first quarter with approximately $10.3 million in cash and cash equivalent, and it worked in capital deficit of approximately $9.4 million.
Mardee Haring-Leighton: As of May 12, 2025, we had approximately 8.9 million shares of common stuff outstanding.
Sabrina Martucci-Johnson: We encourage the best to review the more detailed discussion of our financial condition with quiddity, capital resources, and risk factors in our form 10Q for the quarter ended March 31st, 2025, filed today. I would now like to turn the call back over to Sabrina.
Sabrina Martucci-Johnson: Thank you. So, as we all know, we've been discussing, we are a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority.
Sabrina Martucci-Johnson: Our vision is to meet the increasing demand for evidence-based treatments with both uncompromising scientific rigor and rapid responsible commercialization.
Sabrina Martucci-Johnson: We believe that innovations does not have to start from scratch. Solutions that can address decades of unmet needs in women's health often already have clinical proof of concept for existing safety data for the active ingredient.
Sabrina Martucci-Johnson: We seek to leverage these data and insights in order to bring solutions to market rapidly in a fiscally responsible manner and in ways designed to optimize access for women.
Sabrina Martucci-Johnson: With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting, but access to real, evidence-based solutions still lags behind.
Sabrina Martucci-Johnson: As awareness grows, so does the demand for treatment options, and we are seeking to meet this moment by ensuring women have access to solutions that are not only needed but are evidence-based.
Specifically, despite the fact that the menopause society recommend hormone therapy,
Sabrina Martucci-Johnson: and recommends delivering estrogen and progesterone together for women with intact uterine.
Sabrina Martucci-Johnson: and despite the fact that the menopause society states that non-oral routes to the administration may offer potential advantages.
Sabrina Martucci-Johnson: There is no non-oral hormone therapy that meets those criteria that a woman could administer directly. Dare HRT1 is just that. It's an vaginal ring that a woman can self-administer just once a month.
Sabrina Martucci-Johnson: and Ligar Sedentico Cream Formulation. Dare HRT1 has been evaluated in rigorous toxicology studies and completed pharmacokinetic studies demonstrating the systemic levels of the hormone being administered as measured in the blood of postmenopausal women. Our clinical study findings specific to this proprietary formulation have been published in peer-reviewed journals.
Sabrina Martucci-Johnson: Making our hormone therapy solution available next year via 5x3B compounding crates, a commercial opportunity for Darae, as I mentioned, in the estimated up to $4.5 billion compounded hormone therapy market, and enables women to access this evidence-based solution.
Sabrina Martucci-Johnson: The two vaginal probiotics that we also intend to bring to market this year, as I noted up front, were identified via a grant we received from the Gates Foundation last year.
Sabrina Martucci-Johnson: It was a grant to evaluate the global probiotic manufacturer community and to identify evidence-based solutions and formulations for manufacturers following GMP.
Sabrina Martucci-Johnson: These two products were designed to restore a healthy vaginal microbiome.
Sabrina Martucci-Johnson: and have been evaluated and demonstrated effective in clinical studies in women outside of the United States in restoring a healthy vagremicrobial.
Sabrina Martucci-Johnson: But they are not yet available here and we want women in the US to also have access to these evidence-based vaginal probiotics and we intend to make them available as branded consumer health products later this year.
Sabrina Martucci-Johnson: So this is a good place for me to address the strategic partnerships and collaborations we intend to establish to facilitate access to Dare's on-market brands for women at cross multiple channels for both the prescription products via 503B compounding and branded consumer health products.
Sabrina Martucci-Johnson: As I stated at the beginning of the call, our goal is to bring evidence-based solutions to market, reflecting where and how women are getting and paying for their care.
Sabrina Martucci-Johnson: As I mentioned, that might be an FDA-approved treatment, a compounded product, a consumer health product that does not require prescription, might be available via telehealth, other online platforms, the end-in-person digit with your healthcare provider.
Sabrina Martucci-Johnson: We want men to access these products, these Dari on market brands, from the source they trust, and that reflects where and how they are currently selecting their solutions and getting their care today.
Sabrina Martucci-Johnson: It means partnering with telehealth providers that reflect Dore's mission of challenging the status quo and putting women's health first and that are committed to providing evidence-based solutions.
It means partnering with online retailers that provide complimentary off-brains.
Sabrina Martucci-Johnson: It means collaborating with online prescriptions and fillers so that our formulations are available on their platforms.
Sabrina Martucci-Johnson: And it means participating in medical conferences and continuing medical education programs so that the healthcare community is broadly aware of these evidence-based solutions and they consider their treatment guidelines.
Sabrina Martucci-Johnson: It simply means meeting women where they are, wherever they are.
Sabrina Martucci-Johnson: The delivery of healthcare and the purchase of healthcare solutions has changed dramatically over the last five years and we would not be true to our corporate tagline which is daring to be different. If we did not lean into the latest trends in accessible healthcare and put partnerships and collaboration in place that reflect those trends.
Sabrina Martucci-Johnson: Finally, I should also note that Lyco-Sidenico Cream and our monthly International Hormone Therapy Formulations, there are other proprietary formulations in the DRA portfolio that we can make accessible via prescription through the 5.03B pathway.
Sabrina Martucci-Johnson: We are actively evaluating the dual path approach for some of our other proprietary formulations.
Sabrina Martucci-Johnson: So, that dual path again is to continue to pursue FDA approval of a product candidate for a treatment education while simultaneously bringing that formulation to market via the 503B pathway as soon as practicable.
Sabrina Martucci-Johnson: We're taking this approach as part of our responsibility to women, to the health care community and to our shareholders and because we believe women should not have to wait for needed medical treatment solutions while they continue to pursue an FDA approved path.
Sabrina Martucci-Johnson: Over the next months, we'll continue to provide additional updates, so please stay tuned.
Sabrina Martucci-Johnson: I'm now going to talk through our anticipated 2025 milestones for our therapeutic products, candidates I'll highlight overpring to the NFL Cream and Dare HPV in that regard.
Sabrina Martucci-Johnson: Overpreen again is our novel, investigational, hormone-free, monthly, interventional contraceptives whose commercial rights are under a license agreement with
Sabrina Martucci-Johnson: and Roman is on-going in the pivotal phase 3 contraceptive efficacy study of overpring. Recall that we announced an up to $10.7 million foundation, non-dilutive grant in November 2024, which supported the addition of five new investigator sites in the first quarter of this year.
Sabrina Martucci-Johnson: We've been really pleased with the pace of enrollment at those sites to date, but I will say don't ask me because it's too early for me to predict enrollment rate for the remainder of the study.
Sabrina Martucci-Johnson: I will share though that we do not anticipate that the NICHD, those NIH contracted study sites will resume enrolling new participants under their existing NIH contracts.
Sabrina Martucci-Johnson: Review of the Interim Data by the Study Safety Data Monitoring Board, which is an independent group of experts which evaluates the safety and integrity of the study, is scheduled for this July , July 2025, and we will provide an update following that meeting.
Sabrina Martucci-Johnson: Recall overall that the primary objective of the study is to assess the typical use pregnancy rate over 13 menstrual cycles, or the estimated pearl index for over frame.
Sabrina Martucci-Johnson: Secondary objectives are to assess overprone 13-cycle youth cumulative pregnancy rate, safety, acceptability, product fit, and ease of use, and assessment of vaginal health.
Sabrina Martucci-Johnson: It's successful. We expect the study to support the submission of a pre-market approval application for overprone to the FDA, as well as regulatory filings in Europe and other countries worldwide to allow marketing approval of overprone.
Sabrina Martucci-Johnson: Regarding Syventophyll as an investigational cream formulation of Syventophyll, which is the active ingredient in the oral erectile dysfunction drugs for men, for topical on-demand administration to treat female sexual arousal disorder, we have continued our interactions with the FDA regarding the plan phase 3 study.
Sabrina Martucci-Johnson: and expect more updates on Phase 3 design development and collaboration strategy throughout 2025. We're targeting submission of additional information requested by the FDA, along with a protocol and the statistical analysis plan for the Phase 3 study.
Sabrina Martucci-Johnson: To get those to the FDA by the end of the second quarter of 2025, that's really our immediate next step on this development program on our path to pursuing an FDA approval.
for Dare HPV.
Sabrina Martucci-Johnson: I will remind that in 2024, we were selected to receive an award of up to 10 million.
Sabrina Martucci-Johnson: for the development of Dare HPB, which is an innovative, investigational treatment.
Sabrina Martucci-Johnson: for HPV-related cervical diseases. And with the support of that funding, we're advancing Dare HPV towards a phase 2 clinical study, which is supported with that funding.
Sabrina Martucci-Johnson: Essentially all cervical cancer cases worldwide are caused by HPV infection.
Sabrina Martucci-Johnson: and despite the fantastic advancement in HPV screening and vaccination in the US, an estimated 100,000 women are still treated for cervical pre-cancer each year, and an estimated 4,000 women are expected to die from cervical cancer in 2024.
Sabrina Martucci-Johnson: Today's cervical precancers are monitored until they reach a late stage, since the most common treatment is surgery, which removes parts of the search cervix.
Sabrina Martucci-Johnson: And that surgery is associated with an increased risk of preterm birth and sexual dysfunction so it's not recommended for patients with fertility concerns.
Sabrina Martucci-Johnson: In the US, about 10% of women with HPV infection on the surveys will develop long-lasting HPV infections that put them at risk for cervical cancer.
[inaudible]
Speaker Change: Dare HPV has the potential to be the first FDA-approved pharmaceutical intervention that could treat both general HPV infections in women as well as late-stage cervical dysplasia.
Speaker Change: and Treat That Infection which would change the paradigm around how HPV-related cervical diseases are clinically managed today, preventing surgery, stopping the spread, and transforming care for this critical health issue.
Speaker Change: And Dare's PV is reflective of the type of development program we really like to add to Dara. It's a first-in-category product, but it leverages active pharmaceutical ingredients that have been approved to treat other viral infections.
Speaker Change: Specifically, Dare H.P.V. is an investigational proprietary fixed-dose formulation of LePinnevier and Mitonnevier in a soft gel vaginal insert with the potential to be this first-in-category treatment for H.P.V. infection and H.P.V. related cervical diseases.
Speaker Change: We look forward to continuing to exact activities necessary to enable submission of the IND application to the FDA.
Speaker Change: and for a phase two randomized placebo controlled double-blind clinical study of dare HPV for clearance of high risk HPV infection in women, all supported with the funding we receive under that $10 million award.
Speaker Change: We're excited to be able to provide more updates in the coming months on our therapeutic development programs, as well as our progress as we work to commercialize some of the most potentially disruptive candidates for the health and well-being of women in decades.
Speaker Change: I'd like to now turn the call over to the operator for Q&A.
Speaker Change: Thank you Sabrina. At this time, I would like to remind everyone that in order to ask a question, press star, then the number one on your telephone t-pad. We will pause for just a moment to compile the Q&A roster.
Speaker Change: Let's see your first question. Come on from the line of Douglas Tsao with H.C. Wainwright. Please go ahead.
Douglas Tsao: Hi, good afternoon. Thanks for taking the questions. I guess, Sabrina, you said that we should anticipate several different partnerships in terms of sort of the compounded distribution of products. I'm just curious, would that be, you know,
Speaker Change: Unique Partnerships for each product or could you potentially have multiple partnerships for an individual product?
Speaker Change: Yeah, that's a great question. Thanks for asking for the clarification.
Speaker Change: Both. So, first of all, I want to start out that we would intend...
Speaker Change: to have multiple partnerships for an individual product because we want to make sure, as I mentioned, that that product is available in as many places as possible that makes sense in terms of where women are getting their care and that, like I said, meet our objectives in terms of criteria around.
Speaker Change: You know, that platform having the right commitment and the right access to women on their platforms and where they might have complimentary products as well. So for an individual product, absolutely expect
Speaker Change: Several relationships to support that brand having as wide access as possible and as it makes sense for that particular product and that particular channel being supported.
Speaker Change: But also, as I think maybe intuitive, but just in case it's not
Speaker Change: You know, these platforms that have dealt fantastic relationships with the patients and consumers that use their platforms.
Obviously, it's very compelling for them.
to have access to new products.
and especially evidence-based treatments.
Speaker Change: and Opportunities to partner with Darae, which is leading pharmaceutical developer in the area of women's health. And so, there are also interesting opportunities where Darae products, multiple Darae products could be available on an individual platform as well.
Speaker Change: So, you know, over the coming, as I said over the coming months, expect, you know, more news from us around this, more announcements around this. But the goal is to very simply make sure that.
Speaker Change: These evidence-based treatments are available for the women who are seeking them and for the health care providers that want to provide them. And that means we want to make sure they are on as many platforms and via as many channels as possible. And that's what relationships and collaborations and partnerships will reflect.
Speaker Change: And I guess I'm just curious when you think about, and this is maybe specific to Sadafile Cream, you know, target being sort of in the market by the end of the year, is there much that you need to do to ensure that there is sufficient manufacturing capacity for the product, you know, by your end?
Speaker Change: Another great question. So, we definitely want to make sure that our 503D collaborator on this. So, under 503D
Speaker Change: Just taking a step back for a second, for everyone's benefit. Under 503B, the product, the statutes, the product needs to be manufactured at a registered 503B facility.
Speaker Change: and therefore, you know, we need to support our 503B facility.
Speaker Change: and how to make our proprietary studentical cream right, get them back ready. This is GMP manufacturing, this is not compounding at a pharmacy, this is at an outsourcing facility, which you're regulated by FDA's GMP rules and subject to FDA inspections.
Speaker Change: We need to happen for that manufacturer to be prepared to provide the product at the scale that we need and that's why it's fourth quarter and not yesterday that we were launching this product.
and that's really what that timing is for.
Speaker Change: And in addition to that, though, what that gives us is some nice time between now and then, to do a lot of work around provider education and medical education with the support of the medical institutions that are very focused on sexual health of women.
Speaker Change: and other platforms that are focused on education of providers that are focused in that field. And so what it allows us to do in terms of other preparations.
Speaker Change: is to use this time to make sure that we're supporting those providers with education around disease state, and also education around our specifics, so then it will
Speaker Change: and so those are really the two, you know, the three key sets of activities that are happening between now and this product being commercially available are one supporting our 503B manufacturer.
Speaker Change: with all the supports they need to make sure they're up and running to your point at the scale that we want to support this exciting brand, too. It's the partnerships and collaborations that we've been talking about to ensure the availability of the product.
Speaker Change: Multiple channels and platforms. And the third is that provider, you know, provider education.
Speaker Change: So I will say a group of us are going to be at ACOG, the end of this week, which is the American College of Stetrics and Gynecology Conference.
Speaker Change: It's the first time Darae has a booth at the conference and really we're there for education and to provide some education around what Darae is doing and what's coming soon from our portfolio.
Speaker Change: Sabrina, if I can, one more. I'm just curious because I think you've been talking to potential partners around the dental cream in terms of the traditional FDA approved track. I'm curious if you've gotten feedback from potential partners in reaction broadly from others in the traditional pharmaceutical industry to you taking this step. Thank you.
Speaker Change: Yeah, we definitely have. And I would say, you know, the feedback has been...
Speaker Change: Fantastic and complimentary in terms of our really being open-minded and thoughtful and creative in how we get this product out there as quickly as possible. Everyone.
recognizes and
Speaker Change: Farmer, more than anyone, that drug development can take a very long time, right? Decades in some cases?
Speaker Change: and so that women aren't waiting and they can actually get something that's evidence-based and has been studied.
for a condition for which they are seeking an option. And so the feedback has really been...
Speaker Change: very, very positive. And it's definitely part of, frankly, what's inspired us to really look more broadly across our portfolio, the feedback from the healthcare providers, the feedback from women, and importantly, the feedback from our peer drug developers.
Speaker Change: Okay, great. Thank you so much. I'll start to buy the queue.
[inaudible]
Speaker Change: Here next question comes from the line of Catherine Novack, with a Jones research. Please go ahead.
Speaker Change: Hello. Hi, Sabrina. This is Gleona on for Catherine. Thank you for taking our questions. I'll just start with Sildana Phil, phase three. What additional information has the FDA requested? Can you provide any additional information on?
Speaker Change: In April , we received additional input and information requests from the FDA, regarded our patient-reported outcomes psychometrics, and I don't expect everyone to know what psychometrics means, but basically that's...
Speaker Change: It's about your questionnaires, the test BTS reliability, the content valid or fit for purpose. These are specific terms that are used around stationary reported outcomes.
Speaker Change: and specifically related to both what was done in the Phase 2, but also important me what should be done in Phase 3 as part of that overall final validation, and that's something by the way that was anticipated to be part of the Phase 3 plan and has been discussed
So, um...
Speaker Change: Submission of additional request information along with the actual protocol incorporating that and the statistical analysis plan to the phase three incorporating that to the FDA. We're targeting by the end of this quarter.
Speaker Change: and that's why I say this is, you know, while we would like to target commencement and our targeting commencement of the phase three study, you know, this year, that's really pending as getting this into the FDA and then obviously their review and then any additional feedback we might get in response to this.
Speaker Change: Because obviously we want to face three trials that is ultimately conducted to be very clearly reflective of everything the FDA needs to see in it in order for it to be supportive of registration.
and then in terms of-
Speaker Change: In terms of, you know, it's not an analysis.
Speaker Change: and a planned review for a sample size, so that's not their goal, and in fact, there will not be any statistical assessment.
Speaker Change: of the primary endpoint of the study, and that's the kind of thing that would be needed if there's going to be a sample size change. It's really just looking at safety. Now, having said that, and I've said this a few times, which I think is sometimes surprising.
Speaker Change: to people but two things, one, this is an open label study, it is open label, everyone is on over screen, and two, a pregnancy in a contraceptive study is considered an adverse
Speaker Change: which is the primary endpoint in the study. And there is no opportunity, therefore, to do any kind of sample study size changes based on that because there won't be any assessment of the primary endpoint.
Speaker Change: Great. Thank you so much. And if I could just ask a couple more add-on. Sure. For the compounding drugs, are you pursuing a dual path for all four of those products?
Speaker Change: I guess you've kind of answered this, but what kind of marketing and KL outreach are you doing for the ones that were mentioned today, the probiotics and the hormone therapy?
Yeah, so to clarify, so Sedanisil and the Hormone Therapy.
Speaker Change: to support ongoing development of this product for both of them. It would be the 505B2 regulatory pathway to get a treatment education.
Speaker Change: Plain, if they wanted, we're not interested in that. These are really products designed to restore a vaginal microbiome. And so that is not necessary and there's no other work we're going to be doing on those other than making those available.
in the United States.
Speaker Change: and in terms of efforts to kind of educate and support.
Speaker Change: and then there'll be more efforts on the hormone therapy next year. The good news is it's all the same KOLs and it's all the same medical societies that really focus on those sexual health and menopause.
Speaker Change: And so, we'll be focusing on education programs right now around Sylvain Estell and Iced Adil Ability, but we're also doing a lot to just...
Speaker Change: Awareness Around Dartre, and what we are doing as a leader in ensuring that these evidence-based treatments take it to women and making sure that the healthcare providers are educated on them. So that will really be our focus in the near term, a lot of focus around Sudanese ill and as we get into next year, even more focus on the hormone therapy as well.
Speaker Change: and then obviously, you know, we're making, you know, the consumer health brands is a little bit of a different channel. Although we do think that there are a lot of healthcare providers that are very interested in having a natural evidence-based solution that they can make available to their patients. So we will opportunistically make sure that they're educated on those as well. Thank you very much.
Great. Thank you so much.
Speaker Change: Once again, if you would like to ask a question, press star, one on the telephone keypad.
Speaker Change: Casey, your next question comes from the line of Will Hydeau with Brookline Capital Markets. Please go ahead.
Will Heidel: Hey, Sabrina. Quick question regarding overpring the trial. Does the grant received in November cover cost to add additional sight to me, mentioned in that queue?
Speaker Change: Yeah, thank you. Great question, too. Yeah, so the way that the grant works is really designed to cover the cost of adding a certain number of additional subjects to the study. And we've focused initially on five sites, which frankly, at the rate they're going.
Speaker Change: can be sufficient to add those additional subjects in a very reasonable time frame. So we're going to look at whether there are other sites that we need to open as well. Right now, we're really happy with the pace of enrollment at the five sites, but we definitely have some flexibility to add some additional sites as well.
Okay, great. And then...
Speaker Change: R&D came in a little lower than last quarter. We expect that number to continue going forward or should we see an uptick in that.
Speaker Change: Right now, thanks for asking for that clarification, by the way. Right now, the only ongoing study at this time is the overpring study, and as we are just talking about
Mardee Haring-Leighton: You know, the activities right now are really funded with the grant funding we receive. We do have sometimes, and MarDee kind of eluded this other cost associated with overpring in those rooms. I think the key as well related to manufacturing, just other things that we're doing, obviously to support the product.
Mardee Haring-Leighton: and certain other activities that we might want to kind of lean into even related to the studies sometimes.
Sabrina Haring, Sabrina Johnson
Mardee Haring-Leighton: That's the kind of trend you should expect to continue to see until we have other studies going on at this time.
Okay, thank you. If I get asked one more, um...
with...
Mardee Haring-Leighton: Sold in a Phil Cream. You mentioned, I think, last quarter that you needed about a million dollars to get the 503B operations going. Is that...
Apply to the additional products or will there be an additional cost?
Mardee Haring-Leighton: Oh, that's another great question. Yeah, that's very specific to Savannahville. So that's really the cost associated with supporting our 5-5-3-B manufacturer with the startup text transfer activities like that that are needed to produce GMP, you know, Savannahville cream product. There would be additional costs associated with
Mardee Haring-Leighton: Production Activities and Tech Transfer Activities associated with the Hormel Therapy Product.
They're in a similar range.
Mardee Haring-Leighton: Things like that. So, as we get closer, the Dare HRT1, the Hormone Therapy product, is really targeted for next year. So, as we continue to progress on that and get closer, we'll be able to give even better guidance around that and what those costs are.
Mardee Haring-Leighton: Okay, thank you. But it's the same kind of ballpark, right? We're talking single-digit millions and not tens of millions.
Speaker Change: From that concludes our Q&A session for today. I would like to turn the call back over to Sabrina for any additional or close remarks.
Sabrina Martucci-Johnson: Well, thank you all for taking the time this afternoon and special thanks for the really thoughtful questions. I'll close with basically the same comment I made up front, our repetitions important sometimes, which is that Dari is uniquely positioned to cut through the noise and deliver value to all of our stakeholders, women, healthcare providers, and investors.
Sabrina Martucci-Johnson: Today, biopharmaceutical companies with relatively low risk assets, a competitive advantage, and a path towards near-term revenue are positioned to offer upside, and as I said up front, we believe that is Dara today.
Sabrina Martucci-Johnson: with this business model that I hope you will agree is nimble, allowing us to rapidly commercialize multiple products via multiple channels.
Sabrina Martucci-Johnson: or on-market products will accelerate revenue generation and provide a pass to profitability and we expect to start recording revenue in the fourth quarter of this year.
Sabrina Martucci-Johnson: The portfolio is compelling, and over the next month, as I've said, we look forward to providing updates regarding strategic partnerships and collaborations to facilitate access to our on-market brands for women across multiple channels.
Thank you for listening today and for your support.