Q3 2024 Dare Bioscience Inc Earnings Call
Unknown Executive, MarDee Haring
Unknown Executive, MarDee Haring
Desiree: Welcome to the conference call hosted by Daray 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.
Desiree: With us today from Daray are Sabrina Martucci Johnson, President and Chief Executive Officer, and MarDee Haring-Layton, Chief Accounting Officer.
Ms. Haring-Layton, please proceed.
Unknown Executive, MarDee Haring
Desiree: Good afternoon and welcome to the Dari Bioscience Financial Results and Business Update call for the quarter ended September 30, 2024.
Desiree: Today, we will review our third quarter results and discuss developments and expectations for our pipeline and portfolio.
Desiree: 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.
Desiree: due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter end of September 30, 2024, which was filed today.
Desiree: 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. The RA 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: 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.
Sabrina: We believe Jari 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.
Sabrina: And we remain dedicated to advancing disruptive products for the health and well-being of women through clinical development, regulatory review, and ultimately to market.
Sabrina: Our commitment and focus is to improve health outcomes in the lives of women by leveraging the basic science and pharmacology that is understood.
Sabrina: 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
Sabrina: Broadest portfolio of potentially high-impact, first-in-category product candidates to improve the health and well-being of women, many of which have already demonstrated proof-of-concept, and then our robust pipeline positions as well for the short, medium, and long term.
Sabrina: Our broad portfolio allows us to integrate clinical and regulatory learnings from across our knowledge base.
Sabrina: 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.
Sabrina: We continue to be excited about the increased attention on the health and well-being of women, including by the Advanced Research Projects Agency for Health, or ARPA-H.
Sabrina: 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.
Sabrina: for DARE-HPV, which is an innovative investigational treatment for human papillomavirus or HPV-related cervical diseases.
Sabrina: Essentially, all cervical cancer cases worldwide are caused by HPV infection.
Sabrina: And just this week, we announced an up to $10.7 million grant from the Bill and 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 DARA to expand the number of clinical sites.
Sabrina: in the Ongoing Overpreem Pivotal Study to Accelerate the Development Timeline.
Sabrina: 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 DARE stakeholders.
Sabrina: In addition to the continued commercialization by our collaborator Organon of Daciato, Clindamycin 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 aged 12 and older that is available by prescription nationwide.
Sabrina: We also continue to advance our first-in-category Phase 3 development candidates with ongoing enrollment in our Phase 3 study of oviprene at sites across the U.S.
Unknown Executive, MarDee Haring
Sabrina: and continued constructive interactions with the FDA focused on the lining on the Phase 3 program for Sidenafil Cream 3.6% in female sexual arousal disorder.
Sabrina: 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 3.
Sabrina: 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.
Sabrina: 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,
Sabrina: 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 DARI on track for meaningful milestones in 2025.
Sabrina: 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 Dara's financial results for the quarter ended September 30th, 2024, which I will refer to as the third quarter.
Speaker Change: As Sabrina mentioned, DARA's business strategy is to assemble and advance a portfolio of differentiated product candidates that address meaningful unmet needs.
Speaker Change: We've identified in women's health and then to monetize the value of our portfolios clinical and regulatory advances over the near and long term The investment required to build and advance a portfolio includes corporate overheads portfolio acquisition and maintenance costs and ongoing research and development or R&D expenses
Unknown Executive, MarDee Haring
Speaker Change: Our comprehensive loss for the third quarter was approximately $4 7 million. We ended the third quarter was approximately $11 2 million in cash and cash equivalents and had approximately $8 7 million shares of common stock outstanding as of November November 13th.
Speaker Change: 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.
Speaker Change: 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 but have been and may be issued under our purchase agreement acquired effective by the SEC and a final person.
Speaker Change: <unk> in connection Therewith is filed and the other conditions in the purchase agreement are satisfied.
Speaker Change: In October we also entered into a February agreement with a consortium management firm under which we are entitled to receive funding of up to $10 million and milestone based payments subject charge treatment over an approximately 24 month period of specified research activities and objectives relating to the advancement of our der HPV development Pro.
Speaker Change: Graham, including commencement of the phase III clinical study to evaluate the safety and preliminary efficacy of their HPV for the clearance of high risk HPV infection in women.
Speaker Change: I would agree and that was the result of our selection by ARPA H an agency within the U S Department of health and human services.
Awardee of ARPA Asia, Brent for Women's Health, which was announced by first Lady Joe Biden in February 2024, and is the first major deliverable of the White house initiatives have on women's Health research.
Speaker Change: 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 to fund activities related to the identification and development of a novel non hormonal intra vaginal conscious that.
<unk> product candidates and to add additional clinical study sites intended to accelerate the ongoing overprint pivotal study.
Speaker Change: These non dilutive funding agreements represent our commitment to being creative collaborative and opportunistic and see.
Speaker Change: The capital needed to meet our objective is to build shareholder value. We encourage investors to review the more detailed discussion of our financial our financial condition liquidity capital resources and risk factors in our Form 10-Q for the quarter ended September 32020 for 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: Thanks, Marty I'm now going to talk through our 'twenty 'twenty four accomplishments to date and importantly, with some perspective on how those frame anticipated milestones and with our focus as I mentioned upfront on the late stage candidate late stage candidates at NFL Kremen Overtrain.
Sabrina: But first I do want to provide an update on our on market assets, a shadow so as a reminders a shadow or clindamycin phosphate, 2% vaginal gel them 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.
Sabrina: 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 Oregon on Saar Shadow.
Sabrina: He came available by prescription across the United States.
Sabrina: We've been pleased with Oregon on to progress in this first year of launch as of October the Oregon on Women's health sales team continued to see steady month over month increases in total prescriptions. It's all shadow in line with the opportunity for a new branded entrants into the category and the team continues to work towards novel go to market.
Sabrina: Options and enhancements to ensure a frictionless experience for both patients and providers.
And we're going onto the access team continues to build on the successful coverage achieved at launch through additional wins them. For example, they had a recent addition to the preferred drug list for Texas, Medicaid with no prior off or step edits required and that provides access to an additional $4 1 million patients.
Sabrina: And Oregon on the Womens health field team remains focused on providing that shadow strong clinical value proposition to clinicians, who treat bacterial vaginosis and who continued to affirm their belief that unmet needs exist in this therapeutic area.
Speaker Change: I'll now turn to sit down and feel cream.
As I mentioned upfront, we have continued our constructive interactions with the FDA on the development program for Sudan info 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.
Speaker Change: 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 and 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 mean time, we have been making operational progress towards that planned phase III study.
Speaker Change: As you know there are currently no FDA approved treatments for any form of sexual arousal disorder in women, meaning so that is some cream has the potential to be the first and it's so danville is the active ingredient in tablet form for oral administration currently marketed under the brand name Viagra for the treatment of erectile.
Speaker Change: In men.
Speaker Change: And I don't need to remind you that was undoubtedly one of the most successful prescription products ever launched and market research suggests that 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 Oh, Overpraise wanted to provide an update on the advancement of the phase III study of overpaying, which is our novel investigational hormone free monthly Intervet General contraceptive and the commercial rights for the U S are under a license agreement with Bayer.
Speaker Change: So non hormonal contraception represents a significant commercial market opportunity and there are currently no monthly hormone free contraceptive approved by the F. D. A so overprint has the potential to be a disruptive product in the contraceptive category and an important option for women who cannot use.
Speaker Change: Moen base 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 over prime.
Speaker Change: Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child, Health, and human development or N. I C. H D of the National Institute of health or NIH, and our commercial collaborator Bayer we commenced patient enrollment in the evergreen pivotal phase III clinical study in December 2023.
And as you May recall women are followed over 13 cycles of 12 months of over prime use.
Speaker Change: Recruitment is currently proceeding at a little more than 10 sites across the United States and that supported by a central advertising campaign for the study that launched in March of this year.
Speaker Change: As we discussed last quarter that particular subset of that of the total such studies sites that are ongoing in the trial have been the most successful and translating into study participants that considerable interests. We continue to see from women in response to the Central Africa tightening 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 product to use which is half of the full 12 months and 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 gonna add additional study sites and we expect that to accelerate the study.
Based on the communications to date with the F. D. A if successful we believe that just a single registration study would be required to support our pre market approval application submission with the F. D. A.
Speaker Change: So now onto the Dare HPV program, we mentioned at the start of the call and Marty mentioned, our announcement of the 10 million award that we were selected to receive for their H P V.
Speaker Change: 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.
Speaker Change: And unfortunately, despite the advancements in HPV screening and vaccination, which are fantastic in the United States. An estimated 100000 women are still treated for cervical pre cancer each year.
And even more unsettling an estimated 4000 women will die from cervical cancer in 'twenty to 'twenty four.
Speaker Change: Today cervical pre cancers are monitored until they reach the last stage since the most common treatment.
Speaker Change: Is surgery, which removed as part of the cervix.
Speaker Change: And that surgery is associated with an increased risk of preterm birth in sexual dysfunction, and therefore is not recommended for patients with for so fertility concerns.
Speaker Change: 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 theyre 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 manage today.
Dear H P. V is reflective of the type of development program, we'd like to advance at Dara, It's first in category, but it leverages active pharmaceutical ingredients that have been approved to treat other viral infections. So they are well known and understood specifically their H P. V is an investigational proprietary.
Speaker Change: Fixed dose formulation of lappin of ear and baton of ear in a soft gel vaginal insert with the potential as I mentioned to be very first in category treatment for HPV related cervical diseases.
Speaker Change: We look forward to conducting activities necessary to enable submission of an anda application to the F. T. A for a phase two randomized placebo control controlled double blind clinical study of Dare H P V for clearance of high risk HPV infection in women and all of that will be supported with the funding we received.
Speaker Change: As in ARPA H sprint for women's Health 10 million dollar awardee.
Speaker Change: Yeah.
Speaker Change: We also wanted to provide updates on two of our other first in category product opportunities there.
Speaker Change: Theyre BVA one is our proprietary formulation of tamoxifen for intra vaginal administration and its 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 were conducting activities in preparation.
Speaker Change: Ration for a phase two clinical trial of Dare V. A one based on our FDA cleared I N D for that use.
Speaker Change: And their P. T b, one as I mentioned up front, that's our international ring designed to deliver Bioidentical progesterone continuously over 14 days for the prevention of preterm birth were conducting activities necessary to enable submission of an I N D application to the F. T. A for a phase one clinical study.
Speaker Change: And that's supported by a 2 million dollar grant from NIH C. H D.
Speaker Change: That phase one study will also serve to support safety and PK for this progesterone Intraregional rang to also be investigated for luteal phase support as part of an I V F regimen.
Speaker Change: And finally, I did want to share a little bit more about the grant we just announced from the Bill and Melinda Gates Foundation.
Speaker Change: In addition to the important support for the Overprint clinical trial. The Grandma also support activities to read Derisk. The development of a novel non hormonal intervention contraceptive that could be suitable for women and acceptable for women in low and middle income countries settings, who need or prefer such a product to avoid.
Speaker Change: Nothing planned pregnancy.
Speaker Change: 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 non hormonal product development and our proven ability to advance development of differentiated product candidates to fill unmet needs in women's health.
Speaker Change: So we will receive as Marty outlined an initial payment of approximately $5 4 million under the grant agreement in 'twenty 'twenty four and then additional payments as is typical our 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 Each award, which is also 24 month period.
Speaker Change: For that 10 million disbursement. This 10.7 million disbursement is also over a 24 month period.
So in summary, we continued 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 Oregon on for Josh Shadow and bear for overprint.
Speaker Change: <unk> 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.
Speaker Change: Sabrina will now begin the question and answer session. If you have dialed in and would like to ask a question. Please press star one on your telephone keypad duration has joined the queue.
Speaker Change: If you would like to withdraw your question simply press Star one again if.
Speaker Change: If you are called upon to ask your question and our listening via speaker phone or device. Please pick up your handset to ensure that your phone is not amusement asking a question again fresh Saar wants to join the queue.
Speaker Change: From the line of Catherine Nowak with Jones trading your line is open.
Catherine Nowak: Hi, good afternoon, congrats on all the progress.
Catherine Nowak: So, especially on.
Catherine Nowak: You know being able to expand or accelerate enrollment in the Overplaying study. So just wanted to touch on.
Speaker Change: Potential interim or a potential interim look and <unk> 25 is this something where you're still expecting and then what should we be looking for from this interim readout.
Speaker Change: Safety or how much efficacy can we can we learn from an interim read but yeah. Katherine that's a great question. So thanks for asking and first of all and thank you for the congratulations on the on the non dilutive funding. We got it's 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.
Speaker Change: That right now all of the sites or through the N. I C. H D's clinical trial contraceptive networks, it's going to be really great to be able to add some additional sites to give them experience as well right with with the product outside of that and the opportunity to you know.
Speaker Change: Go even faster with the program. So we're thrilled about that in terms of you know getting partway through that that important enrollment milestone and in and kind of having that critical you know halfway mark in terms of subjects and time in this study it's definitely an important place for us to to look at.
Speaker Change: The data as people.
Speaker Change: 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. There, they're all getting active part product, there's no placebo control them and that does create interesting opportunities like this to continue to look at safety. We do you have a data safety monitoring.
Speaker Change: Ward as well as other considerations throughout the course of the study.
Speaker Change: 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 bear them on as well as we think this through as well as obviously.
Speaker Change: The data safety monitoring.
Speaker Change: Board and charter for it for the program and the reason I say that is that.
Speaker Change: This is a 12 months or 13 cycle Ultimate contraceptive study and there's a lot of data to indicate that contraceptive rates I'm just get better freight over time. So that's one of the things we're going to have to think about in terms of you know, what we'd look at and and how any sort of disclosure.
Speaker Change: Would be handled around that so more to come on that it's it's an active and ongoing discussion with our you know commercialization collaborator. So a bear so we will we will give more updates on that as we get closer.
Speaker Change: Great and then just one more on.
Speaker Change: 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 what's still outstanding when it comes to your FDA interactions do you need any additional information or are you you know did.
Speaker Change: Do they have anything else that they need from you in order to move this along.
Yeah more great question. So first of all what I mean in terms of operational progress is.
Speaker Change: I'm kind of taking a step back and actually going to the second part of your question around discussions with the F. D. A.
Speaker Change: Really our discussions with the FTA have importantly, very much been focused on you know at the end of phase two they're always focused on big picture right I'll, what I'll do we need for the NDA submission of course, that's an important part of end of phase two but in a circumstance like this when you're pursuing development of a first in category product for which.
Speaker Change: You know the the first in category fantastic opportunities because no one's done this before him 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.
Speaker Change: To monitor what's important to demonstrate them. So really that's been 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 you know we've we've shared before that the expectation is to.
Speaker Change: Phase III trials to support registration, but you know the detail around what exactly does that entail and what it's going to be required. So that's really where the focus has been and the phase two data is so rich there as you know it was a learning experience for everyone in terms of the patient population the endpoints.
Speaker Change: No, 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 [laughter] and these interactions you know it. It's it's not like you did get to just you know called the F. D. A every day [laughter] and have a conversation so.
Speaker Change: It's you know, it's very sort of process in terms of how communication goes back and forth. So it's really just going through that answering questions getting feedback and I'm you know in the mining, but as I said up front. It's been very constructive we've been you know very pleased with how constructive the F. D. A has been.
Speaker Change: Then in collaborating with us and wanting very much to also get us to the place.
Speaker Change: 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 what we're really trying to insure them you know importantly around.
Speaker Change: Expectations for success.
Speaker Change: So that we can clearly communicate those and we all know what we're working towards in terms of their than operational readiness, it's really around making sure that as soon as we reach that alignment.
Speaker Change: We're ready to go so ready to go and the things that you know we can control such as making sure C. R. O that we want to work with making sure. We know the sites that we want to work with them you know, making sure that we have drug supply them. So that you know we're not waiting to manufacture.
Speaker Change: Or something so those are all the things right that that are completely within our control and that we've been doing to make sure that we are you know operationally ready such that all we're waiting for is <unk>.
Having.
Speaker Change: That phase III protocol that we know everyone's aligned on.
Speaker Change: So that we can then you know initiate the process to go obviously, we always have to think about.
Speaker Change: You know 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.
Speaker Change: Some of the structures that Marty talked about that we've put in place.
Speaker Change: Got it that makes sense definitely looking forward to hearing some of those updates when you're able to share them.
Speaker Change: Thanks again for taking my questions. Congrats on all the progress. Thank you.
Speaker Change: Our next question comes from the line of Douglas Tsao with H C. Wainwright. Your line is open.
Speaker Change: Hello.
Speaker Change: Mr. Douglas Tsao I think your microphone is on mute.
Speaker Change: Alright. Our next question comes from the line of Ken Oliver.
From Brookline capital markets. Your line is open.
Yeah.
Speaker Change: Thank you I'm definitely not on mute.
Speaker Change: [laughter]. So you know a couple of questions.
Speaker Change: If I may.
Speaker Change: You know with yogurt Marine trial.
Speaker Change: Potential interim look.
Speaker Change:
Speaker Change: Yes.
Speaker Change: Obviously, it wouldn't be at a point, where you would.
Speaker Change: Rob could trial early so what it says.
Speaker Change: Big actions might fall follow from.
Speaker Change: Youre doing that analysis.
Speaker Change: Yeah. It's a great question. So you know with the D. S. M is charged with is really obviously monitoring safety. So that's routine and and it's a great question and that's part of why there's obviously been discussion around it one can look because it's open label.
Speaker Change: So one can you know take could take a look obviously you you don't there's no value in doing that until you've got you.
Speaker Change: You know you're kind of far enough in the end in the study to have enough patients in cycles.
You know in order to to to look at anything frankly safety or efficacy perspective, and and so there isn't anything specific beyond that that I can say at this time, it's it's one of those situations, where one can and and the reason that time point is also important is you know it is.
Speaker Change: Sort of the.
Speaker Change: You know partway through the study and they're they're really there isn't any.
Contraceptive product at least to my knowledge that's.
Speaker Change: Ever been studied for less than that time period, right you need a certain number of cycles in six months at least I'm looking at these methods and so that's why that time point you know for us its been something you know we've thought about and when are we going to be there right. It's an important sort of milestone you know I wish I had it clear.
Speaker Change: Question for you like I said up front. There there are things that you know we have to think about in terms of you know what we look at that 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 Pearl index between six and 13 months always getting.
Speaker Change: Better you know over that time frame. So that does you know raised considerations and particularly also for our commercialization partner Bayer So.
Speaker Change: More to follow as we get closer importantly, you know, we obviously will be you know doing R. R. T. S. M safety assessments and that's also an important win at that point as well.
Okay, that's great and just.
Speaker Change: That particular trial for the moment.
Speaker Change: So you have 10 sites now youre going to have some additional funding available how many additional sites.
Do you intend to add.
Speaker Change: Yeah. That's a great question, so and just to be clear too we have theres Theres 20 total sites under the clinical trial contraceptive network under the NIH and you know all of those sites have been involved in this study and obviously you know would have active patients that are.
Speaker Change: <unk> to be followed we are focusing now recruitment efforts on them a little more than half so a little more than 10 mm 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 translate.
Speaker Change: The interest from the patients and from women in the study into study participants. So you know we want to be thoughtful with the resources that we have together under a collaborative research agreement with the NIH that really covers those sites in the study and so that's why as we think about forward.
Speaker Change: Looking recruitment, we're really focused on that that 10, plus sites through that C. C T and group of sites. The additional funding will you know likely allow us to add you know a handful of sites.
Speaker Change: You know to the study, which for a study of this size and just give it a how many sites. We've we've had and how many have been really are our active you know a really efficient and rollers that you now 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.
Speaker Change: And besides that or outside of the C. C. T N network, we've been honored him and really happy to be working with the C. C. T N network the clinical contraceptive clinical trial networks at work so closely with the NIH, but we've also had fantastic experience with.
Speaker Change: The community based sites that have worked with us on all of our other studies. They ran ours a shadow study they've been and understood that initial study. So we're also very excited to get a chance to work with some of them an overprint as well because they've been very anxious to do so.
Speaker Change: Great and my last question relates to slow.
Speaker Change: And just to think about the potential timeframe.
Speaker Change:
Once you get FDA.
Speaker Change: Alignment.
Speaker Change: Hmm.
Speaker Change: The operational requirements.
Speaker Change: Certainly having one thing.
Speaker Change: We just need to get funding as being the most gating factor here.
Speaker Change: Have you already get funding say next few months.
How soon do you think you'd be able to.
Speaker Change: You initiate the trial.
Speaker Change: Yeah. Another great question I mean, really if you think about operations like studies start up we've done as much as we can upfront, but they're still operational things that you know where where that take you know not days, but weeks and and you know some of them several weeks around contracting besides things he can't do even though we knew.
Speaker Change: Who we want to work with you can't do until you have the final protocol going through IRB you know so so those are those things that.
You know, we'll go as fast as we can but there is traditional studies start up that.
Speaker Change: Some of those things we cannot do until we have the final protocol. So that to your point you know on protocol and funding. You know then it's just says traditional study startup activities that.
Speaker Change: You know can often take a couple to a few months realistically with site initiations as well.
Speaker Change: So it would start next year is possible.
Speaker Change: Absolutely, yes, absolutely.
Yeah. Once we get that final protocol you know.
Speaker Change: Aligned with the F. D. A then yeah then it's down to your point, obviously always have to think about the money importantly, but then it's really just that operational studies start up things like the higher beta site contracts and the said initiations.
Speaker Change: Okay.
Speaker Change: Thank you.
Thanks.
Speaker Change: Next question from Douglas Tsao with H C. Wainwright. Your line is now open.
Speaker Change: Hi, Good afternoon can you hear.
Speaker Change: Jeremy This is Tom yes, yes. Thank you okay.
Sabrina I'm just curious in terms of Overprint study. The addition of these new sites.
How quickly do you anticipate them sort of being able to.
Enroll studies.
Speaker Change: In the trial and ultimately.
Speaker Change: Do you have a sense of what percentage of the total enrollment might come from.
Speaker Change: Besides an either or.
Speaker Change: Sure.
Speaker Change:
Speaker Change: Different types of patients that will be added by going outside of the CPM.
Speaker Change: Okay.
Speaker Change: Yeah more great questions. So you know as I kind of alluded to in the last question you know from from Camp. These are you know 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 them you know some.
Speaker Change: Of them have done both our bacterial vaginosis study as well as to sit NFL studies. Some of them. Just did one you know of those studies, but what that translates into is like we've contracted with them before we've worked with them before so we they're are going to be efficiencies that would be very different than if we were going out to like brand new sites.
Speaker Change: That we don't know so our expectation is that you know again. This is still it's weeks right. It's not days, it's weeks to get through this process, but our expectation is you know we're going to work really quickly to get those sites up and going as quickly as possible you know I've been going through.
Speaker Change: As possible in the new year right, we're going to use this time now through the end of the year or two to work quickly with them and we know who they are that we want to work with and in terms of your you're also great question around is going to bring into the study you know different types of subjects you know, where we're also always looking at demographics as well.
Speaker Change: In terms of you know the women that are enrolling in the study and we do want to ensure we are you know hitting some diversity objectives in different parts of the country as well that you know, we're allowing them to participate in the studies to it also does give us.
Speaker Change: You know some additional.
Speaker Change: I think kind of opportunity in that regard as well that we want to be very thoughtful about in and leveraging and then in terms of you know what proportion of the subjects them could they contribute to the study.
Speaker Change: So these are again these are sites that have performed very.
Speaker Change: Very well for us historically in terms of translating them like in the Sudan NFL study translating again interest into participants and that's not trivial by the way and you know the the clinical trial contraceptive network sites have been great and and just some of them are better than that at that at others for this particular.
Speaker Change: <unk> study.
Speaker Change: 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 to can be very including in past contraceptive studies that they've run can be very efficient.
Speaker Change: In translating someone who's interested and meets the eligibility criteria for the study into a study participants.
And you know if they do that well they can make a meaningful you know when we're not so far along in the study that they can't make a meaningful contribution they can still make a meaningful contribution.
Speaker Change: Two the study participants and and we think that would be great. In terms of also just overall diversity in the study.
Speaker Change: Diversity of site.
Speaker Change: Okay. That's helpful and Sabrina Hugh Hugh you did mention sort of the amount of funding that would be needed to fully complete.
Speaker Change: To complete this identical program I'm, just curious about how some thoughts on.
Speaker Change: How much of that you need upfront to begin a program.
Speaker Change: Yeah.
Speaker Change: Yeah I mean this is you know the.
Speaker Change: You know I would say at a particular study and individuals' study, we're estimating based on all the conversations we've been having with the F D E and M as well as the CRO.
Speaker Change: It's about 15 million you know have a sort of direct external costs related to the to each of the studies. So that's 30 in total if you add the two together. So you know certainly there's not an expectation that we'd want to make sure. We had 30 million before we started them, but you know it.
Speaker Change: The trial is $15 million and so 15 is an important number for us to think about now having said that this is not.
You know, it's obviously, it's on a life threatening condition and it's you know the expectation is it's going to be out a fairly you know it's a shorter study period, you know for the women who are participating.
Speaker Change: So.
Speaker Change: You know there you can be creative around that in terms of how much you literally need upfront before you start because it's such a short period of time, you can you know keep enrolling and completing right people. So those are all things we're going to look at at the time, but I think the important thing is to understand that we don't need 30 million.
Speaker Change: But an individual study is $15 million and we'd want to make sure you know we feel very confident I'm, even if not all of that is there upfront that we feel very confident that you know we're going to be able to continue the women through the study.
Speaker Change: Okay, great. Thank you so much that's helpful.
Speaker Change: Yeah.
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.
Speaker Change: Well. Thank you all for taking the time this afternoon to hear about a recent updates in our ongoing commitment to drive value for all of <unk> stakeholders by identifying and advancing potential new therapies to provide additional choices and hence outcome and ease of use for women and as you heard today, we continue to make great progress and with our Uni.
Speaker Change: <unk> model, including being able to leverage them you know a lot of non dilutive funding that we just brought in over the last months.
Speaker Change: And the support of our commercial collaborators, we believe are well positioned to accelerate innovation for women everywhere, while also driving value for all of <unk> stakeholders. So we look forward to keeping you updated on our progress and we thank you for listening today.
Speaker Change: Yeah.
Ladies and gentlemen. This concludes today's conference call you may now disconnect.
Speaker Change: [music].