In the recent conference call on November 14, 2024, Daré Bioscience, Inc. (DARE) provided an update on its third-quarter financial results and the progress of its women's health product pipeline. CEO Sabrina Martucci Johnson announced that the company secured over $20 million in non-dilutive funding, which will support the development of key products such as Ovaprene, a hormone-free contraceptive, and Sildenafil Cream for female sexual arousal disorder.
Despite reporting a comprehensive loss of $4.7 million for the quarter, the company highlighted a decrease in R&D and administrative expenses and a healthy cash position of $11.2 million. Daré is also collaborating with Bayer (OTC:BAYRY) and has received significant funding from ARPA-H and the Gates Foundation to advance its innovative treatments.
Key Takeaways
- Daré Bioscience focuses on developing products for women's health, with a portfolio covering contraception, sexual health, and other areas.
- The company received over $20 million in non-dilutive funding, including grants from ARPA-H and the Gates Foundation.
- Q3 saw a comprehensive loss of $4.7 million, but R&D and administrative expenses decreased significantly.
- Daré has a cash and equivalents balance of $11.2 million and an equity line agreement with Lincoln Park for $15 million in stock sales.
- Key products like Ovaprene and Sildenafil Cream are advancing through clinical trials.
- XACIATO, a treatment for bacterial vaginosis, is seeing a steady increase in prescriptions and has been added to Texas Medicaid's preferred drug list.
Company Outlook
- Daré is focused on advancing its portfolio of women's health products.
- The company is leveraging recent non-dilutive funding to drive innovation and stakeholder value.
- Collaboration with Bayer and funding from ARPA-H and the Gates Foundation are crucial to the company's progress.
Bearish Highlights
- The company reported a comprehensive loss of $4.7 million for the third quarter.
- Full funding is not yet secured for the commencement of all planned clinical trials.
Bullish Highlights
- Non-dilutive funding over $20 million will support product development and clinical trials.
- Prescription growth for XACIATO and its inclusion in Texas Medicaid's preferred drug list may signal increasing market acceptance.
- The addition of new clinical trial sites is expected to expedite enrollment and enhance participant diversity.
Misses
- While there is prescription growth for XACIATO, the company did report a comprehensive loss, indicating ongoing challenges in achieving profitability.
Q&A Highlights
- Discussions with the FDA are ongoing regarding the Sildenafil Cream Phase III study endpoints.
- The company is preparing operationally for trial initiation, pending funding and protocol alignment.
- Daré aims to begin the Ovaprene study in 2024, with the addition of new sites expected to improve enrollment efficiency.
- Each study in the sildefanil program is estimated to require $15 million in direct external costs.
Daré Bioscience's commitment to advancing women's health therapies was evident throughout the earnings call. The company's strategic focus on securing non-dilutive funding and collaborating with established partners like Bayer and Organon suggests a proactive approach to overcoming the challenges inherent in pharmaceutical development. As Daré continues to navigate the regulatory pathways and funding opportunities, the progress of its innovative products will be closely watched by stakeholders and industry observers alike.
InvestingPro Insights
Daré Bioscience's recent financial update and strategic developments can be further contextualized with insights from InvestingPro. The company's market capitalization stands at $30.47 million, reflecting its position as a small-cap player in the biotech sector. This valuation aligns with the company's current stage of product development and recent funding achievements.
InvestingPro data reveals that Daré's revenue for the last twelve months as of Q2 2023 was $2.84 million, which underscores the company's early-stage nature and the importance of the non-dilutive funding it has secured. The gross profit margin of -662.27% for the same period highlights the significant costs associated with research and development in the biotech industry, particularly for companies with products still in clinical trials.
Two relevant InvestingPro Tips provide additional context:
1. Daré is quickly burning through cash, which is consistent with the company's focus on advancing its product pipeline and the need for substantial funding to support clinical trials.
2. Analysts do not anticipate the company will be profitable this year, aligning with the reported comprehensive loss and the typical trajectory of biotech firms investing heavily in R&D.
These insights reinforce the importance of the $20 million in non-dilutive funding and the company's strategic partnerships for its future growth. Investors considering Daré Bioscience may find value in exploring the additional 5 tips available on InvestingPro to gain a more comprehensive understanding of the company's financial health and market position.
Full transcript - Dare Bioscience Inc (DARE) Q3 2024:
Catherine Novack - JonesTrading :
Brian Kemp Dolliver - Brookline Capital Markets:
Douglas Tsao - H.C. Wainwright :
Operator: Welcome to the conference call hosted by Daré Bioscience to review the company's Third Quarter Financial Results and to provide a general business update. This call is being recorded. My name is Desiree and I will be your operator today. With us today from Daré are Sabrina Martucci Johnson, President and Chief Executive Officer and MarDee Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton. Please proceed.
MarDee Haring-Layton: Good afternoon and welcome to the Daré Bioscience financial results and business update call for the quarter ended September 30, 2024. Today we will review our third quarter results and discuss developments and expectations for our pipeline and portfolio. I would 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 cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended September 30, 2024 which was filed today. I would also like to point out that the content of this call includes time sensitive information that is current only as of today, November 14, 2024. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call except as required by law. I will now turn it over to Sabrina.
Sabrina Martucci Johnson: Thank you and thank you for joining the call today. We have a number of updates to cover including regarding the over $20 million in non-dilutive funding that we announced in just the last 30 days. So, we very much look forward to taking you through them. We believe Daré is the only publicly traded company focused solely on women's health pharmaceutical product development broadly across contraception, sexual health, pelvic pain, fertility, infectious disease and menopause. And we remain dedicated to advancing disruptive products for the health and wellbeing of women through clinical development, regulatory review and ultimately to market. Our commitment and focus is to improve health outcomes in the lives of women by leveraging the basic science and pharmacology that is understood about certain active pharmaceutical ingredients and marketed products to accelerate innovative treatments that women want and need by boldly addressing existing therapeutic gaps and we believe this is a competitive advantage. We believe we have the broadest portfolio of potentially high impact first and category product candidates to improve the health and wellbeing of women, many of which have already demonstrated proof of concept and that our robust pipeline positions us well for the short, medium and long-term. Our broad portfolio allows us to integrate clinical and regulatory learnings from across our knowledge base. And this is what has allowed us to conduct eight successful clinical trials to date and hold 25 FDA interactions across six product candidates in 2023 and 2024 alone. We continue to be excited about the increased attention on the health and wellbeing of women, including by the Advanced Research Projects Agency for Health or ARPA-H, as evidenced by their recent announcement related to the awardees of the ARPA-H Sprint for Women's Health and our announcement under that program of the $10 million award we were selected to receive for DARE-HPV, which is an innovative investigational treatment for human papillomavirus or HPV related cervical diseases. Essentially all cervical cancer cases worldwide are caused by HPV infection. And just this week we announced an up to $10.7 million grant from the Bill & Melinda Gates Foundation to support activities that will aid in the identification and development of novel non hormonal intravaginal contraceptive product candidates. And will also provide funding to allow Daré to expand the number of clinical sites in the ongoing Ovaprene pivotal study to accelerate the development timeline. We continue to execute on our mission to accelerate development of and bring to market innovative treatments that as I mentioned earlier, women want and need. And we do this by advancing our late-stage candidates, all of which represent a first in category opportunity as we seek to deliver value for all of Daré's stakeholders. In addition to the continued commercialization by our collaborator Organon of XACIATO clindomycin phosphate vaginal gel 2%, which is the first FDA approved product to emerge from our portfolio and which is a treatment for bacterial vaginosis in females age 12 and older that is available by prescription nationwide. We also continued to advance our first in category Phase III development candidates with ongoing enrollment in our Phase III study of Ovaprene at sites across the US and continued constructive interactions with the FDA focused on the lining on the Phase III program for Sildenafil Cream 3.6% in female sexual arousal disorder. As we've discussed before, despite its high prevalence, there are currently no FDA approved treatments for female sexual arousal disorder and we look forward to advancing this program into Phase III. Additionally, we are conducting activities in preparation for a Phase II clinical study of DARE-VVA1 and a Phase I study of DARE-PTB1 which is supported by a $2 million grant from NICHD, all of which I will cover briefly today. The progress across our portfolio, along with the $10.7 million grant announcement yesterday and the $10 million award from ARPA-H announced in October, the $15 million equity line arrangement we established with Lincoln Park Capital Fund LLC or Lincoln Park in October and the $22 million we secured in the non-dilutive strategic royalty financing in the second quarter put Daré on track for meaningful milestones in 2025. We have a number of updates on our development portfolio to that end that I will provide today. But before I do, I'm going to first turn it back over to our Chief Accounting Officer, MarDee, to review the third quarter financial results.
MarDee Haring-Layton: Thanks, Sabrina and thanks everyone for joining us today. I would now like to summarize Daré's financial results for the quarter ended September 30, 2024, which I will refer to as the third quarter. As Sabrina mentioned, Daré's business strategy is to assemble and advance a portfolio of differentiated product candidates 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. The investment required to build and advance a portfolio includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development or R&D expenses. During the third quarter of 2024, our general and administrative expenses were approximately $2 million, which is a 24% increase compared to Q3. I'm sorry, decrease compared to Q3 2023 due primarily to reduce professional services expenses and reduce commercial readiness expenses. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory and other activities across our entire portfolio were approximately $2.7 million for the third quarter, which is a 60% decrease compared to Q3 2023. As we guided previously, this year, we continue to anticipate our full year 2024 R&D expenses will be less than our 2023 R&D expenses. Our comprehensive loss for the third quarter was approximately $4.7 million. We ended the third quarter with approximately $11.2 million in cash and cash equivalents and had approximately $8.7 million shares of common stock outstanding as of November 13. In October, we entered into an equity line arrangement with Lincoln Park, pursuant to which we have the right, but not the obligation to sell to Lincoln Park and Lincoln Park is obligated to purchase up to $15 million of our common stock. Such sales of common stock, if any, will be subject to certain limitations and may occur from time to time at our sole discretion over the 24 month period commencing on the date that a registration statement covering the resale by Lincoln park of shares that have been and may be issued under our Purchase Agreement is declared effective by the SEC and a final prospectus in connection therewith is filed and the other conditions in the Purchase Agreement are satisfied. In October we also entered into a subaward agreement with a consortium management firm under which we are entitled to receive funding of up to $10 million in milestone based payments subject to our achievement over an approximately 24 month period of specified research activities and objectives relating to the advancement of our DARE-HPV development program, including commencement of a Phase II clinical study to evaluate the safety and preliminary efficacy of DARE-HPV for the clearance of high risk HPV infection in women. The subaward agreement was the result of our selection by ARPA-H, an agency within the U.S. department of Health and Human Services, as an awardee of ARPA-H's Sprint for Women's Health, which was announced by First Lady Jill Biden in February 2024 and as the first major deliverable of the White House Initiative on Women's Health Research. In addition, as Sabrina mentioned and I will share more about later, we announced yesterday that we entered into a grant agreement with the foundation for a grant of up to approximately $10.7 million, approximately $5.4 million of which we expect to receive this year. The fund activities related to the identification and development of a novel non hormonal intravaginal contraceptive product candidate and to add additional clinical study sites intended to accelerate the ongoing Ovaprene pivotal study. These non-dilutive funding agreements represent our commitment to being creative, collaborative and opportunistic and seeking the capital needed to meet our objectives and to build shareholder value. We encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources and risk factors and our Form 10-Q for the quarter ended September 30, 2024 which we filed this afternoon, as well as our annual Form 10-K for the year ended December 31, 2023 which was filed on March 28, 2024. I would now like to turn the call back over to Sabrina.
Sabrina Martucci Johnson: Thanks, MarDee. I'm now going to talk through our 2024 accomplishments to date and importantly with some perspective on how those frame anticipated milestones and with a focus, as I mentioned upfront on the late stage candidates Sildenafil Cream and Ovaprene. But first I do want to provide an update on our on-Market Asset XACIATO. So as a reminder, XACIATO or clindomycin phosphate 2% vaginal gel is the first FDA approved product to emerge from our portfolio. It's indicated, as I mentioned, upfront for the treatment of bacterial vaginosis in females 12 years of age and older. As you may recall, it's a colorless single-dose vaginal gel that can be applied at any time of day. And it's formulated with the goal of limiting leakage and increasing vaginal retention time, known as time spent in place. And in the first quarter of this year, of 2024, through our commercialization agreement with Organon, XACIATO became available by prescription across the United States. We've been pleased with Organon's progress in this first year of launch. As of October, the Organon women's health sales team continued to see steady month-over-month increases in total prescriptions of XACIATO, in line with the opportunity for a new branded entrant in the category. And the team continues to work towards novel go-to-market fulfillment options and enhancements to ensure a friction-less experience for both patients and providers. And Organon's access team continues to build on the successful coverage achieved at launch through additional wins. For example, they had a recent addition to the preferred drug list for Texas Medicaid with no prior auths or step edits required. And that provides access to an additional 4.1 million patients. And Organon's women's health sales team remains focused on providing XACIATO's strong clinical value proposition to clinicians who treat bacterial vaginosis and who continue to affirm their belief that unmet needs exist in this therapeutic area. I'll now turn to Sildefanil Cream. As I mentioned upfront, we have continued our constructive interactions with the FDA on the development program for Sildefanil Cream as a treatment for female sexual arousal disorder, including, importantly, with respect to the proposed efficacy endpoints to take forward into Phase III development. As we've mentioned several times, this would be the first ever Phase III pivotal study of a therapeutic candidate for the treatment of arousal disorder in women. We look forward to providing updates on the FDA's feedback, the Phase III study designs and plans, as well as any relevant updates on our collaboration strategy as they become available. In the meantime, we have been making operational progress towards that planned Phase III study. As you know, there are currently no FDA-approved treatments for any form of sexual arousal disorder in women, meaning Sildefanil Cream has the potential to be the first. And it's -- sildefanil is the active ingredient in tablet form for oral administration, currently marketed under the brand name Viagra for the treatment of erectile dysfunction in men. And I don't need to remind you, that was undoubtedly one of the most successful prescription products ever launched. And market research suggested approximately 20 million women in the U.S. experience symptoms of low or no sexual arousal. So, we look forward to providing additional updates on the development program as they are available. In terms of Ovaprene, wanted to provide an update on the advancement of the Phase III study of Ovaprene, which is our novel investigational hormone-free monthly intravaginal contraceptive. And the commercial rights for the U.S. are under a license agreement with Bayer. So nonhormonal contraception represents a significant commercial market opportunity. And there are currently no monthly hormone-free contraceptives approved by the FDA. So Ovaprene has the potential to be a disruptive product in the contraceptive category and an important option for women who cannot use hormone-based birth control products or prefer not to do so. Based on market research, approximately 35 million women in the U.S. alone are potential candidates for Ovaprene. Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD of the National Institute of Health, or NIH, and our commercial collaborator Bayer, we commenced the patient enrollment in the Ovaprene pivotal Phase III clinical study in December 2023. And as you may recall, women are followed over 13 cycles or 12 months of Ovaprene use. Recruitment is currently proceeding at a little more than 10 sites across the United States, and that's supported by a central advertising campaign for the study that launched in March of this year. As we discussed last quarter, that particular subset of the total substudy sites that are ongoing in the trial have been the most successful and translating into study participants that considerable interest we continue to see from women in response to the central advertising campaign. So based on the current average enrollment rate, we anticipate that approximately half of our target number of participants to complete the study or 125 women will complete approximately six months of product use, which is half of the full 12 months, by the end of the second quarter of 2025. With the grant funds we expect to receive this year under the grant agreement we just announced yesterday, we're going to add additional study sites, and we expect that to accelerate the study. Based on the communications to date with the FDA, if successful, we believe that just the single registration study would be required to support a premarket approval application submission with the FDA. So now on to the DARE-HPV program. We mentioned at the start of the call and MarDee mentioned our announcement of the $10 million award that we were selected to receive for DARE-HPV. As I mentioned, it's an innovative investigational treatment for HPV-related cervical diseases. And I can't stress enough that essentially all cervical cancer cases worldwide are caused by HPV infection. And unfortunately, despite the advancements in HPV screening and vaccination, which are fantastic, in the United States, an estimated 100,000 women are still treated for cervical precancer each year. And even more unsettling, an estimated 4,000 women will die from cervical cancer in 2024. Today, cervical precancers are monitored until they reach the last stage since the most common treatment is surgery, which removes part of the cervix. And that surgery is associated with an increased risk of preterm birth and sexual dysfunction, and therefore, is not recommended for patients with fertility concerns. In the U.S., about 10% of women with HPV infection on their cervix will develop long-lasting HPV infection that puts them at risk for cervical cancer. So, DARE-HPV has the potential to be the first FDA-approved pharmaceutical intervention that could treat both late-stage cervical lesions as well as earlier-stage HPV-related cervical infections. And that could really change the paradigm around how HPV-related cervical diseases are clinically managed today. Their HPV is reflective of the type of development program we like to advance at Daré. It's first in category, but it leverages active pharmaceutical ingredients that have been approved to treat other viral infections, so they're well known and understood. Specifically, DARE-HPV is an investigational proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert with the potential, as I mentioned, to be very first-in-category treatment for HPV-related cervical diseases. We look forward to conducting activities necessary to enable submission of an IND application to the FDA for a Phase II randomized placebo-controlled double-blind clinical study of DARE-HPV for clearance of high-risk HPV infection in women. And all of that will be supported with the funding we received as an ARPA-H Sprint for Women's Health $10 million awardee. We also wanted to provide updates on two of our other first-in-category product opportunities. DARE-VVA1 is our proprietary formulation of tamoxifen for intravaginal administration. And it's being developed as a hormone-free alternative to estrogen-based therapies for the treatment of moderate to severe dyspareunia, which is pain during sexual intercourse. And we're conducting activities in preparation for a Phase II clinical trial of DARE-VVA1 based on our FDA-cleared IND for that use. And DARE-PTB1, as I mentioned up front, that's our intravaginal ring designed to deliver bioidentical progesterone continuously over 14 days for the prevention of preterm birth. We're conducting activities necessary to enable submission of an IND application to the FDA for a Phase I clinical study. And that's supported by a $2 million grant from NICHD. That Phase I study will also serve to support safety and PK for this progesterone intervaginal ring to also be investigated for luteal phase support as part of an IVF regimen. And finally, I did want to share a little bit more about the grant we just announced from the Bill & Melinda Gates Foundation. In addition to the important support for the Ovaprene clinical trial, the grant will also support activities to derisk the development of a novel nonhormonal intravaginal contraceptive that could be suitable for women and acceptable for women in low- and middle-income country settings who need or prefer such a product to avoid unplanned pregnancy. We believe that we're the right organization to move innovations like these programs forward given our extensive experience in the contraceptive space, in particular, with novel nonhormonal product development and our proven ability to advance development of differentiated product candidates that fulfill unmet needs in women's health. So, we'll receive, as MarDee outlined, an initial payment of approximately $5.4 million under the grant agreement in 2024, and then additional payments, as is typical, are contingent upon our achievement of certain development and reporting milestones specified in the grant agreement, during the approximately 24 months period term of that grant agreement. So similar to the ARPA-H award, which is also a 24-month period, for that $10 million disbursement. This $10.7 million disbursement is also over a 24-month period. So in summary, we continue to progress our portfolio of potential first-in-category product candidates and look forward to providing more updates as we work to advance some of the most potentially disruptive candidates for the health and well-being of women in decades, collaborating with leading companies, including Organon for XACIATO and Bayer for Ovaprene, as well as funding agencies, to commercialize and deliver these treatments to as many women as possible. I'd now like to turn the call over to the operator for Q&A.
Operator: [Operator Instructions] From the line of Catherine Novack with Jones Trading. Your line is open.
Catherine Novack: Hi, good afternoon. Congrats on all the progress. Congrats especially on being able to expand or accelerate enrollment in the Ovaprene study. So, I just wanted to touch on the potential interim or the potential interim look by the end of 2Q '25. Is this something we're still expecting? And then what should we be looking for from this interim readout? Just safety? Or how much efficacy can we learn from an interim read?
Sabrina Martucci Johnson: Yes. Catherine, that's a great question. So, thanks for asking. And first of all, thank you for the congratulations on the nondilutive funding we got. It's a really nice addition to be able to add some sites, additional sites to the study. And we're really excited to do that. Right now all of the sites are through the NICHD's clinical trial contraceptive network. So, it's going to be really great to be able to add some additional sites to give them experience as well, right, with the product outside of that and the opportunity to go even faster with the program. So, we're thrilled about that. In terms of getting partway through that important enrollment milestone and kind of having that critical halfway mark in terms of subjects and time in this study, it's definitely an important place for us to look at the data. As people may or may not recall, this is open label. That's standard for any contraceptive trial in that everyone in the study, just for ethical reasons, right, they're all getting active product. There's no placebo control. And that does create interesting opportunities like this to continue to look at safety. We do have a data safety monitoring board, as well as other considerations throughout the course of the study, evaluating it. In terms of exactly what information will be reviewed at that time and what may be made publicly available and how that will be handled, that's really something that we are working closely with our commercialization collaborator with Bayer on as well as we think this through as well as, obviously, the data safety monitoring board and charter for the program. And the reason I say that is that this is a 12-month or 13-cycle ultimate contraceptive study, and there's a lot of data to indicate that contraceptive rates just get better, right, over time. So that's one of the things we're going to have to think about in terms of what we look at and how any sort of disclosure would be handled around that. So more to come on that. It's an active and ongoing discussion with our commercialization collaborator, so Bayer. So, we will give more updates on that as we get closer.
Catherine Novack: Great. And then just one more on sildefanil. Can you share a little bit more about what you mean by operational progress towards Phase III? And if you can let us know what's still outstanding when it comes to your FDA interaction? Do you need additional information? Or are you -- do they have anything else that they need from you in order to move this along?
Sabrina Martucci Johnson: Yes. More great question. So, first of all, I mean, in terms of operational progress is, kind of taking a step back and actually going to the second part of your question around discussions with the FDA. Really our discussions with the FDA have, importantly, very much been focused on -- at the end of Phase II, they're always focused on big picture, right, what all do we need for the NDA submission, of course. That's an important part of end of Phase II. But in a circumstance like this, when you're pursuing development of a first-in-category product for which the first-in-category fantastic opportunity is because no one has done this before. And so a lot of the focus is really on what should be the appropriate endpoints, right, for a Phase III program, what's important to monitor, what's important to demonstrate. So really that's then a lot of the focus of the conversation and what does that Phase III program look like, right? What are the expectations in terms of efficacy and safety from that Phase III program? And we've shared before that the expectation is to Phase III trials to support registration. But the detail around what exactly does that entail and what's going to be required. So that's really where the focus has been. And the Phase II data is so rich. There's -- it was a learning experience for everyone in terms of the patient population, the endpoints, where they see improvement, where they want to see improvement. And so, it's really just going through all that. So frankly, more than anything, it's just time. And these interactions, it's not likely to get to just call the FDA every day and have a conversation. So, it's very sort of processed in terms of how communication goes back and forth. So really just going through that, answering questions, getting feedback, and aligning. But as I said up front, it's been very constructive. We've been very pleased with how constructive the FDA has been in collaborating with us and wanting very much to also get us to the place where we can be ready to go, but making sure they understand how important it is to us and our shareholders that there's great alignment on the expectations for Phase III. So that's where we're really trying to ensure, importantly, around expectations for success, so that we can clearly communicate those and we all know what we're working towards. In terms of then operational readiness, it's really around making sure that, as soon as we reach that alignment, we're ready to go. So where do you go in the things that we can control, such as making sure CRO that we want to work with, making sure we know the sites that we want to work with, making sure that we have drug supply so that we're not waiting to manufacture something. So those are all the things, right, that are completely within our control and that we've been doing to make sure that we are operationally ready such that all we're waiting for is having that Phase III protocol that we know everyone is aligned on so that we can then initiate the process to go. Obviously, we always have to think about financial considerations, which is also why we've tried to make sure that we're ready for that as well in terms of some of the structures that MarDee talked about that we've put in place.
Catherine Novack: Got it. That makes sense. Definitely looking forward to hearing some of those updates when you're able to share them. Thanks again for taking my questions. Congrats on all the progress.
Operator: Thank you. Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is open.
Sabrina Martucci Johnson: Hello?
Operator: Mr. Douglas Tsao, I think your microphone is on mute. All right. Our next question comes from the line of Kemp Dolliver from Brookline Capital Markets. Your line is open.
Brian Kemp Dolliver: Thank you. I'm definitely not on mute. So, a couple of questions, if I may. With the Ovaprene trial and this potential interim look, you're -- obviously, it wouldn't be at a point where you would stop the trial early. So what specific actions might follow from doing that analysis?
Sabrina Martucci Johnson: Yes, it's a great question. So what the DSM is charged with is really obviously monitoring safety. So that's routine. And this is a great question. That's why there's obviously been discussion around it. One can look as it's open label. So, one can take a look. Obviously, you don't -- there's no value in doing that until you've got -- you're kind of far enough in the study to have enough patients and cycles in order to look at anything, frankly, safety or efficacy perspective. And so there isn't anything specific beyond that that I can say at this time. It's one of those situations where one can. And the reason that time point is also important is it is sort of the partway through, right, the study. And there really -- there isn't any contraceptive product, at least to my knowledge, that's ever been studied for less than that time period, right? You need a certain number of cycles and six months, at least, looking at these methods. And so that's why that time point for us has been something we've thought about. And when are we going to be there, right? It's an important sort of milestone. I wish I had a clear question for you. Like I said upfront, there are things that we have to think about in terms of what we look at then and what we do with that information given what we know very well in the literature about contraceptive studies and how there can be changes in the Pro Index between six and 13 months, always getting better over that time frame. So that does raise considerations and particularly also for our commercialization partner, Bayer. So more to follow as we get closer. Importantly, we obviously will be doing our DSM safety assessments and that's also an important one at that point as well.
Brian Kemp Dolliver: Okay. That's great. And just stay on that particular trial for the moment. So you have 10 sites now. You're going to have some additional funding available. How many additional sites do you intend to add?
Sabrina Martucci Johnson: Yes, that's a great question. And just to be clear, too, we have there's 20 total sites under the clinical trial contraceptive network under the NIH. And all of these sites have been involved in the study and obviously would have active patients that are continuing to be followed. We are focusing now recruitment efforts on a little more than half, so a little more than 10, of the sites that, as I mentioned on the August call and kind of reiterated today, have really been quite exceptional in terms of how they've translate the interest from the patient from women in the study into study participants. So we want to be thoughtful with the resources that we have together under our collaborative research agreement with the NIH that really covers those sites in the study. And so that's why as we think about forward-looking recruitment, we're really focused on that 10-plus sites through that CCTN group of sites. The additional funding will likely allow us to add a handful of sites to the study which, for a study of this size and just given how many sites we've had and how many have been really are active, really efficient enrollers that can have a meaningful impact. So that's why we're super excited about being able to do it. And it allows us to add sites that are outside of the CCTN network. We've been honored and really happy to be working with the CCTN network, the clinical -- Contraceptive Clinical Trial Network that works closely with the NIH. But we've also had fantastic experience with community-based sites that have worked with us on all of our other studies. They were in our XACIATO study, they've been in our sildefanil study. So, we're also very excited to get a chance to work with some of them on Ovaprene as well because they've been very anxious to do so.
Brian Kemp Dolliver: Great. And my last question relates to sildefanil and just to think about the potential time frame once you get FDA alignment and with the operational requirements and certainly having funding. So if we just think of funding as being the most gating factor here, if you were to get funding, say, next month, how soon do you think you'd be able to initiate the trial?
Sabrina Martucci Johnson: Yes, another great question. I mean, really, if you think about operation -- like study start-up, we've done as much as we can upfront but there's still operational things that we're -- that take not days, but weeks, and some of them several weeks, around contracting the sites, things we can't do even though -- we know who we want to work with. You can't do until you have the final protocol going through IRB. So those are those things that will go as fast as we can. But there is traditional study start-up that some of those things we cannot do until we have the final protocol. So that, to your point, on protocol and funding, then it's just those traditional study start-up activities that can often take a couple to a few months, realistically, with site initiations as well.
Brian Kemp Dolliver: So a start next year is possible?
Sabrina Martucci Johnson: Absolutely. Yes, absolutely. Yes. Once we get that final protocol aligned with the FDA, then yes, then it's down to your point, obviously, always have to think about the money, importantly. But then it's really just that operational study start-up, things like the IRB, site contracts, and the site initiation.
Brian Kemp Dolliver: Great, thank you.
Operator: Next (LON:NXT) question from Douglas Tsao with H.C. Wainwright. Your line is now open.
Douglas Tsao: Hi, good afternoon. Can you hear me this time?
Sabrina Martucci Johnson: Yes, yes. Thank you.
Douglas Tsao: Okay. Sabrina, I'm just curious in terms of the Ovaprene study and the addition of these new sites. How quickly do you anticipate them sort of being able to enroll study in the trial? And ultimately sort of do you have a sense of what percentage of the total enrollment might come from these sites? And will there be sort of different types of patients that will be added by going outside of the CCTN network?
Sabrina Martucci Johnson: Yes, more great question. So, as I kind of alluded to in the last question from Kemp, these are sites that we've identified that we would like to add to the study are sites that we've had great experiences with in the past and have a nice track record with. Some of them have done both our bacterial vaginosis study as well as the sildefanil study. Some of them just did one of those studies. But what that translates into is like we've contracted with them before. We've worked with them before. So, we -- there are going to be efficiencies that would be very different than if we were going out to like brand-new sites that we don't know. So our expectation is that, again, this is still it's weeks, right? It's not days. It's weeks, to get through this process. But our expectation is we're going to work really quickly to get those sites up and going as quickly as possible. So I've been going as quick as possible in the new year, right? We're going to use this time now through the end of the year to work quickly with them, and we know who they are that we want to work with. And in terms of your also great question around is it going to bring into the study different types of subjects, we're also always looking at demographics as well, in terms of the women that are enrolling in the study. And we do want to ensure we are hitting some diversity objectives in different parts of the country as well that we're allowing to participate in the study. So, it also does give us some additional, I think, kind of opportunity in that regard as well that we want to be very thoughtful about and leveraging. And then in terms of what proportion of the subjects could they contribute to the study, these are, again, these are sites that have performed very well for us historically in terms of translating, like in the sildefanil study, translating again interest into participants. And that's not trivial by the way. And the Clinical Trial Contraceptive Network sites have been great and just some of them are better than others for this particular study. And so that's what it's going to come down to, is sort of how the interest is there. And we're selecting sites that have shown us in the past can be very -- including in past contraceptive studies that they've run, can be very efficient in translating someone who's interested and meets the eligibility criteria for the study into a study participant. And if they do that well, they can make a meaningful -- we're not so far along in the study that they can't make a meaningful contribution. They can still make a meaningful contribution to the study participants. And we think that would be great in terms of also just overall diversity in the study, and diversity of sites.
Douglas Tsao: That's helpful. And Sabrina, you did mention sort of the amount of funding that would be needed to -- for the -- to complete the sildefanil program. I'm just curious about how some thoughts on how much of that you need upfront to begin the program?
Sabrina Martucci Johnson: Yes. I mean this is the -- I would say particular study, an individual study, we're estimating, based on all the conversations we've been having with the FDA and as well as the CRO, it's about $15 million of sort of direct external costs related to each of the study. So that's $30 million in total, if you add the two together. So certainly, there's not an expectation that we would want to make sure we had $30 million before we started. But a particular trial is $15 million, and so 15 is an important number, for us to think about. Now having said that, this is not -- it's, obviously, it's not a life-threatening condition, and it's -- the expectation is it's going to be a fairly -- it's a shorter study period for the women who are participating. So there, you can be creative around that in terms of how much you literally need upfront before you start because it's just a short period of time you can keep enrolling and completing right, people. So those are all things we're going to look at the time. But I think the important thing is to understand that we don't need $30 million. But an individual study is $15 million, and we'd want to make sure we feel very confident, even if not all of that is there upfront, that we feel very confident that we're going to be able to continue the women through the study.
Douglas Tsao: Okay, great. Thank you so much. That's helpful.
Operator: That concludes the question-and-answer session. I would like to turn the call back over to Sabrina Martucci Johnson for any additional or closing remarks.
Sabrina Martucci Johnson: Thanks. 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 Daré's stakeholders by identifying and advancing potential new therapies to provide additional choices and, hence, outcome and ease of use for women. As you heard today, we continue to make great progress. And with our unique model, including being able to leverage a lot of nondilutive funding that we just brought in over the last month, and the support of our commercial collaborators, we believe we're well positioned to accelerate innovation for women everywhere, while also driving value for all of Daré stakeholders. So, we look forward to keeping you updated on our progress, and we thank you for listening today.
Operator: Ladies and gentlemen, this concludes today's conference call. You may now disconnect.
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