Q4 2024 Dare Bioscience Inc Earnings Call
Welcome to the conference call hosted by Dar Bioscience to review the company's 2024 financial results and to provide a business update.
This call is being recorded.
Joe: My name is Joe and I'll be your operator stay with us today from Dara or Sabrina.
Speaker Change: <unk> Johnson, President and Chief Executive Officer.
Speaker Change: And Marty Harry Legion, Chief Accounting Officer Hari later please proceed.
Speaker Change: Good afternoon, and welcome to the Dar Bioscience financial results and business update call for the year ended December 31, 2024 today, We will review our results discuss developments and expectations for our pipeline and portfolio and discuss our expanded business strategy to include 503 be compounding as a dual path approach.
Speaker Change: To bring some of our proprietary formulations to market as soon as practicable 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.
Speaker Change: Historical facts should be considered forward looking statements actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties you should not place undue reliance on forward looking statements forward looking statements are qualified in their entirety by the cautionary statements and the company that you see.
Speaker Change: Filings, including our Form 10-K for the year ended December 31, 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 March 31, 2025, sorry undertakes no obligation to update any forward looking statements to reflect new ones.
Sabrina: Formation or developments after this call except as required by law I will now turn it over to Sabrina.
Speaker Change: Thank you.
Speaker Change: Thank you all for joining the call today, we have a number of updates to cover and I'll start with the one that I expect to you like we are now excited to discuss which is our announcement today regarding our target to make our proprietary so Dennis Gilles cream formulation available this year.
Speaker Change: We use that to accelerate innovation in women's health and our goal is to fulfill the urgent need for access to evidence based treatment options with increasing demand for needed treatments designed for women, we're taking action to make our proprietary sudanophilic cream formulation available via prescription.
Speaker Change: Here as a compounded drug under section 503, B of the F. D. C. A because we believe women should not have to wait for access to our formulation when an alternative legal pathway via section 503 D is available while we continue to pursue FDA approval of our product candidate.
Speaker Change: After urging on the part of the health care community and hearing the demand for women, we are targeting to make our proprietary sudanophilic cream formulation available via 1503 be registered outsourcing facility partner in the fourth quarter of 2025.
Speaker Change: So Dan it jumps to tread citrate, which as you know is the same active ingredient in an erectile dysfunction drug for men appears on the S. E. T. H <unk> interim list of bulk drug substances. Its therefore eligible for this pathway.
Speaker Change: Health care providers prescribe compounded drugs to patients when an FDA approved drug is not available or medically appropriate to treat them.
Speaker Change: Well compounding most commonly occurs in pharmacies that are not subject to fda's current good manufacturing practice or cgmp regulations 503 be registered outsourcing facilities are a category of compounded <unk> established in 2013 by the drug quality and Security Act.
Speaker Change: Outsourcing facilities must be registered with the F. T. A they are subject to FDA inspections and are subject to increased quality standards, including compliance with cgmp regulations.
Speaker Change: Because we believe women shouldn't have to wait for access to needed medical treatment, making our proprietary sudanophilic cream formulation available via prescription via one partnered five or three be registered outsourcing facility is part of our dual path approach, meaning we will also continue to pursue FDA approval.
Speaker Change: Obviously, then it felt cream as a treatment for female sexual arousal disorder in women.
Speaker Change: Bringing our proprietary to them, it's a cream formulation to market via a five a three peat compounding will not impact the regulatory process or commercial opportunity for an FDA approved. She then its all crane product rather if successful it accelerates the availability of this proprietary formulation for a health care.
Speaker Change: Providers and the women seeking it and it accelerates revenue from this proprietary formulation and provides non dilutive source of capital to Dara.
Speaker Change: It could also provide a real world evidence and experience that we would seek to utilize to streamline the path to FDA approval of this burst in category candidate for an indication for which there are no FDA approved treatment options.
Speaker Change: We're a biopharmaceutical company driven by our mission to challenge the status quo, making women's health a priority.
Speaker Change: We believe that innovation does not have to start from scratch. Our goal is to bring to market as soon as practical practical innovative evidence based solutions that address decades of unmet needs in women's health and enhance outcomes and convenience primarily in the areas of contraception sexual health pelvic P.
Speaker Change: Jane fertility infectious disease digital health and menopause.
Speaker Change: The potential products, we identify in many cases already have clinical proof of concept or existing safety data for the active ingredient that we leverage this gives us optionality and flexibility in many cases in how we seek to bring their solutions to market in ways designed to all.
Speaker Change: Optimize access for women in a fiscally responsible manner.
Speaker Change: With growing awareness around menopause sexual health and vaginal health the conversation is shifting but access to real evidence based solutions still lags behind.
Speaker Change: As awareness grows so does the demand for treatment options. We are seeking to meet this moment by ensuring women have access to solutions that are not only needed, but our evidence based.
Speaker Change: A dar of women's health isn't just a priority. It is our purpose with a track record of FDA approved innovation and a commitment to scientific rigor, we continuously here from health care providers and women themselves about the urgent need for faster access to trusted evidence based treatments.
Speaker Change: Following the publication of our clinical studies findings demand for our sedan initial cream formulation has only grown reinforcing the critical need to bring our proprietary formulation to market as quickly as possible.
Speaker Change: To our knowledge, it's the only cream formulation of Sudan is so they can check all five of the following important boxes for health care providers and women.
Speaker Change: One our proprietary seed NFL cream formulation has completed toxicology studies, including reproductive toxicology.
Speaker Change: Two our proprietary Pseudocoel cream formulation has completed pharmacokinetic studies in both men and women.
Speaker Change: Three our proprietary suite NFL cream formulation is the only formulation to a completed randomized placebo controlled studies in women.
Speaker Change: For our clinical studies finding specific to this proprietary formulation have been published in peer reviewed journals and featured on the American College of Obstetricians and Gynecologists podcast.
Speaker Change: And five if our proprietary seed NFL cream formulation has brought to market by prescription under section 503, B. It would be manufactured by FDA registered outsourcing facility subject to increase quality standards, including cgmp regulations, as I mentioned and FDA inspections.
Speaker Change: We're committed to a strategy that optimizes for access in a fiscally responsible way we.
Speaker Change: We will focus our resources on provider to provider education about disease state and our proprietary formulation leveraging online resources, including web based ordering platforms and collaborations with telehealth platforms and providers.
Speaker Change: As such we do not anticipate needing to invest more than a million dollars to support the activities required to make our sildenafil cream formulation available via our partner <unk> registered outsourcing facility as an option for health care providers and women this year.
Speaker Change: We expect to start recording revenue and cash flow in the fourth quarter of this year.
Speaker Change: And we are targeting the second quarter of 2025 to provide an update on the strategic partnerships to achieve all of these objectives.
Speaker Change: I'd also like to add that like our suite NFL cream formulation. There are other proprietary formulations in the diary portfolio that we can make accessible via a prescription through the FDA 500 <unk> pathway.
Speaker Change: We are actively evaluating a dual path approach for some of our other proprietary formulations that is to continue to pursue FDA approval of our product candidate for a treatment indication while simultaneously, bringing our proprietary formulation to market via the section 500 <unk> pathway.
Speaker Change: 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 we continue to pursue FDA approval of our product candidates.
Speaker Change: In addition, we may also bring to market consumer health products that can be obtained without a physician's prescription.
Speaker Change: We are targeting the second quarter of 2025 to provide an update on timing and strategic partnerships to achieve these objectives as well.
Speaker Change: These initiatives reflect the five key elements of our business strategy.
Speaker Change: One accelerate innovation in women's health and bring our proprietary formulations and other assets to market as soon as we can utilizing all available pathways for the asset. This includes but is not limited to compounded drug under section 503 be FDA approved product.
Speaker Change: Or as a non prescription and consumer health product.
Speaker Change: To advance clinical development of the product candidate in our portfolio through mid to late stage clinical development or regulatory approval.
Speaker Change: We have a commitment to scientific rigor.
Speaker Change: Three pursue strategic collaborations to fund our business enhance our development and commercialization capabilities and or our commercial offerings optimizing for access in a fiscally responsible manner.
Our product candidates, we intend to develop and maintain strategic relationships with commercial stage companies that are leaders or emerging leaders in women's health as well as other entities, where we believe such collaborations will help fund our business or accelerate or otherwise improve upon our clinical development or regulatory stress.
Speaker Change: <unk>, a product manufacturing to our commercialization capabilities.
Speaker Change: For the fiber <unk> compounding opportunities, we intend to develop and maintain relationships with section 503 billion registered outsourcing facilities to help bring our proprietary formulations to market and make them available to the health care providers and women. So they don't have to wait for needed solutions.
Speaker Change: Four explore opportunities to expand our portfolio with evidence based solutions to improve women's health as our sole focus.
Speaker Change: While simultaneously advancing our current portfolio, we intend to continue to identify other important areas of unmet need in women's health and to explore opportunities to build our portfolio by acquiring or in licensing new programs that meet our selection criteria.
Speaker Change: And five to seek non dilutive sources of funding to support product development we.
We look forward to sharing more today regarding the up to $28 7 million in non dilutive funding that we became eligible to receive that we announced just as recently as the fourth quarter of 2024.
The diversity of our portfolio the progress, we're making in advancing our product candidates and the revenue opportunity from our proprietary suite NFL cream formulation based on our announcement today put diary on track for meaningful milestones in 2025.
Speaker Change: So before I provide additional updates on those anticipated milestones I'm going to first turn it back over to our Chief Accounting Officer, Marty to review our year end 2024 financial results.
Marty: Thanks, Sabrina and thanks, everyone for joining us today I would now like to summarize our financial results for the year ended December 31, 2024, which I'll refer to as the yearend results.
Marty: Simply dairy business strategy is to assemble and advance our portfolio of differentiated product candidates that address meaningful unmet needs. We've identified had women's health and then to monetize the value of our portfolio of clinical and regulatory advances over the near and long term.
Marty: The investment required to build and advance our portfolio includes corporate overhead portfolio acquisition and maintenance costs and ongoing research and development or R&D expenses.
Marty: During 2024, our general and administrative expenses were approximately $9 2 million, which is a 24% decrease compared to 2023 due primarily to reduced commercial readiness expenses and reduced head count we continue to maintain a lean and focused team and are managing overhead costs closely our R&D expenses.
Marty: Which vary from period to period based on clinical and preclinical manufacturing regulatory and other development program costs were approximately $14 2 million for 2024, which is a 34% decrease compared to 2023, we reported a comprehensive loss for 2020 for a $4 5 million.
Marty: And ended the year with approximately $15 7 million in cash and cash equivalents and working capital deficit of approximately $3 2 million as Sabrina mentioned in 2024, we entered into two new agreements for non dilutive funding awards, one from a federal agency and the other from the Gates foundation totaling up to 'twenty.
Marty: 7 million includes the royalty monetization transaction in which we received $22 million in gross proceeds together the royalty financing non dilutive funding agreements represent our commitment to being creative collaborative and opportunistic in seeking the capital needed to meet our objectives and to build shareholder value.
Marty: As of March 28, 2025, we had approximately $8 9 million shares of our common stock outstanding.
Marty: 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-K for the year ended December 31, 2020 for which we filed this afternoon I would now like to turn the call back over to Sabrina.
Marty: Thank you Marty and now I'm going to talk through the 2024 accomplishments and the anticipated 2025 milestones obviously with the focus on Sudanophilic cream, but also overcoming in phase III study first I'll provide an update on our on market asset Zasyadko. So as a reminder, our shadow or clindamycin phosphate 2% vaginal.
Marty: <unk> is our first FDA approved product to emerge from our portfolio. It's indicated for the treatment of bacterial vaginosis in females 12 years of age and older.
Marty: Colorless single dose vaginal gel that can be applied any time of day and it's formulated with the goal of limiting leakage and increasing natural retention time known as time spent in place.
In the first quarter of 2024 through our commercialization agreement with Oregon on that Shadow became available by prescription across the United States and we have been pleased with Oregon on its progress in this first year of watch.
Marty: In 2024, we entered into a strategic royalty financing with zama, wherein we received as Marty mentioned $22 million in gross proceeds at close as a result of this transaction I want to remind you that future payments related to the shadow we'd come directly from XOMA upon such time XOMA achieve the pre buy.
Marty: Slide total return on its investment demo would then be required to pay down or a 50% of each successive $22 million of domo received under the transaction agreement, we look forward to keeping you updated.
Marty: Now turning back to Sudan infill as I mentioned upfront after urging on the part of the health care community Andy hearing the demand from women, we're targeting to make our proprietary suite NFL cream formulation available by prescription from a fiber <unk> registered outsourcing facility in the fourth quarter of this year of 2020.
Marty: Five.
Marty: As I mentioned already in the second quarter of this year, we will provide an update on our strategic partnerships to achieve this objective.
Marty: This is part of our dual path approach I previously discussed because we believe women should not have to wait for needed treatments and solutions.
Marty: In terms of our continuing process of pursuing the FTA approval of Sildenafil cream as a treatment for female sexual arousal disorder. In December of 2024, we announced our plans for phase III development based on the constructive interactions we've been having with the FDA, including with respect to the co primary and secondary.
Marty: Because the endpoints for our phase III studies.
Our first phase III study of CIT NFL cream would be the first ever phase III pivotal study of a therapeutic candidate for the treatment of arousal disorder in women.
Marty: Pending review of additional forthcoming recommendations from the FDA that impact our statistical analysis plan for this study we plan to submit the protocol and the statistical analysis plan, reflecting the fda's recommendations to the FDA in the second quarter of this year.
Marty: They are currently as I mentioned, no FDA approved treatment for any form of sexual arousal disorder and women. So this means that to the NFL cream has the potential to be the first.
Marty: Market research suggests that approximately 33% of women and the ages in the U S and the ages of 21% to 60.
Experience symptoms of low or no sexual arousal and as a reminder, in 2021, when we ran the targeted ads on Facebook and Instagram for ours today, they feel cream phase <unk> clinical trial in 45 U S cities, we received over 10000 responses in the first 16.
Marty: Weeks alone.
Marty: We look forward to providing additional updates on all of our initiatives around our proprietary suite NFL cream formulation in the second quarter. This year.
Marty: Now turning to <unk>, we also want to provide an update on the advancement of the phase III study of Evergreen, which is our novel investigational hormone free monthly interventional contraceptive who's a U S. Commercial rights are under a license agreement with Bayer.
Marty: Non hormonal contraception represents a significant commercial market opportunity. There are currently no monthly hormone free contraceptive approved by the FDA.
Marty: <unk> has the potential to be a disruptive product in the contraceptive category, an important option for women, who cannot use hormone based birth control products or prefer not to do so and based on market research. We believe approximately 27 million women in the U S alone are potential candidates for <unk>.
Marty: Working with steady collaborators at the Eunice Kennedy Shriver National Institute of Child, Health, and human development or and I C. H D of the National Institute of health or NIH, and our commercial collaborator Bayer recommenced patient enrollment in the evergreen Phase III study in December of 2023 20 <unk>.
Marty: Nickel research sites from within the NFC Hd's contraceptive clinical trials network or CCT and were trained on the protocol and were initiated to start screening and enrolling participants in late 2023 and primarily early 2024.
Marty: Currently there are 15 active ni CH <unk> sites following enrolled participants in the study.
Marty: Enrollment is currently proceeding at five study sites outside of the CCT and there were initiated in 2025 funded by that grant we received in 2024 from the Gates Foundation to accelerate the overall study timeline.
Marty: We anticipate that approximately 125 women, which is half of our target number of participants to complete the study will complete approximately six months of over prime used by the end of the second quarter of 2025.
Marty: As you May recall this is a designated checkpoint for review of interim data by the study's data safety monitoring board or D. SMB, an independent group of experts, which evaluates the safety and integrity of the study.
Marty: Yeah.
Marty: I should note at this time that executive orders and other actions taken by the U S. Presidential administration in the first quarter of 2025 have negatively impacted the phase III study in <unk> ability to carry out its responsibilities under the credo.
Marty: Due to the uncertainty relating to federal contract and funding for research and development.
Marty: Croutons at CCT and sites has been paused to preserve funds that are already under those existing contracts between the CCT insights and Nic's D for the already enrolled subjects.
Marty: So at this time due to the uncertainty with the CCT and sites and because of the five new study sites. Only recently began participate enrollment we cannot reasonably predict the enrollment rate for the remainder of the phase III study or an estimated time for completion of enrollment.
Marty: But we look forward to providing updates as soon as we can this year on that and we definitely look forward to the review of the interim data by the DSM V. This summer.
Marty: I will stress the timing of which will not be affected by the current pause in recruitment at the CCT and site since those participants have already been enrolled.
Marty: I also want to remind you that based on communications to date with the FTA. If successful we believe that just this single registration study would be required to support our pre market approval application with the FDA.
And now let me turn to a couple of other programs in our portfolio very quickly as we wrap up.
First human papilloma virus in.
Marty: In 2024, we were selected to receive an award of up to $10 million for development of der HPV, which is our innovative investigational treatment for HPV related cervical diseases and with the support of that funding, we're advancing deere HPV towards the phase II clinical study SM.
Marty: Essentially all cervical cancers worldwide are caused by HPV infection and despite the advancements in HPV screening as well as vaccination in the U S. An estimated 100000 women are still treated for cervical pre cancer each year and an estimated 4000 women are expected to die.
Marty: From cervical cancer in 2024.
Marty: Today cervical pre cancers are monitored until they reach late stage since the most common treatment is surgery, which essentially just removes part of the cervix. However, the surgeries associated with an increased risk of preterm birth in sexual dysfunction, and therefore, it's not recommended for women with fertility concerns.
Marty: In the U S about 10% of women with HPV infection. Other service cervix will develop long lasting HPV infections that put them at risk for cervical cancer.
Marty: So Dara HPV has the potential to be the first FDA approved pharmaceutical intervention that can treat both general HPV infections in women as well as late stage cervical dysplasia pre cancers, which could change the paradigm around how HPV related cervical diseases are clinically manage today.
Marty: <unk>, preventing surgery, stopping the spread and transforming the care for this critical health issue.
Marty: Dear HPV is reflective of the type of development program, we like to advance to Dore, It's a first in category product, but it leverages active pharmaceutical ingredients that have been approved to treat other viral infections.
Marty: Specifically their HPV is an investigational proprietary fixed dose formulation of <unk> and <unk> in a soft gel vaginal insert. So it has the potential to be a first in category treatment for HPV infection, and HPV related cervical diseases doing using two well known antiviral agents.
Marty: We look forward to continuing to conduct 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.
Marty: Our HPV for the clearance of high risk HPV infection in women all supported with the funding we received under the $10 million reward.
Marty: I also want to briefly provide updates on a couple of other of our programs.
Marty: Specifically Deere BVA, one which is our proprietary formulation of tamoxifen for Intravascular administration being developed as a hormone free alternative to estrogen based therapies for the treatment of moderate to severe dyspareunia or pain during sexual intercourse.
Marty: We're conducting activities in preparation for our phase II clinical trial of Dare <unk> BVA, one based on our FDA cleared IND that happened last year. This is one of our product candidates intended to really shift the menopause treatment landscape gaps in solutions for menopause symptoms have given rise to an.
Marty: Closure of untested supplement and therapies, we believe that developing new FDA approved therapies to meet the needs of women and their doctors can shift the focus to rigorously studied safe and effective hormonal and non hormonal treatment options.
Marty: And they are P. TV, one which is our intraregional ring designed to deliver bioidentical progesterone continuously for up to 14 days for the prevention of preterm birth, which we are conducting activities necessary to enable an I N D. And then subsequently a phase one clinical study, which are and will be supported by a $2 million grant.
Marty: From an IC HD.
Marty: The phase one study I should point out would also serve to support the safety and pharmacokinetics for this progesterone intraregional rating to also be investigated for luteal phase support as part of an IVF regimen.
Marty: Our progesterone intraregional rain could reduce or eliminate the need for painful daily injections during IVF a potential game changer for women enduring this growing process. So.
Marty: In summary, we continue to accelerate innovation in women's health and seek to bring to market as soon as possible innovative evidence based solutions that address persistent unmet needs in areas of women's health that we believe represent compelling and meaningful market opportunities.
Marty: We plan to achieve this goal in ways that seek to optimize access to needed treatment solutions in a fiscally responsible manner as I've mentioned.
Speaker Change: <unk> expanding our business strategy to include section 500, <unk> compounding as a dual path approach to bring some of our proprietary formulations to market as soon as practical.
Speaker Change: We will continue to seek to advance the product candidates in our portfolio through mid to late stage clinical development of regulatory approval and to establish a leverage strategic partnerships and other collaborations to complete product development and commercialize the products and as I mentioned, we also may bring forward consumer market helped consumer health products.
Speaker Change: Market that can be obtained without a physician's prescription.
Speaker Change: We look forward to providing more updates on the above in the second quarter as we work to advance the commercialization strategies and some of the most and to commercialize some of the most potentially disruptive candidates for the health and wellbeing of women in decades.
Speaker Change: Now I'd like to turn the call over to the operator for Q&A.
Speaker Change: Thank you Sabrina we will now begin the question and answer session.
Speaker Change: Got it and I would like to ask a question. Please press star one on your telephone keypad ratio Hannan joined the queue.
Speaker Change: If you would like to withdraw your question simply press Star one again.
Speaker Change: Our first question comes from the line of Catherine Novak from Jones trading. Please go ahead.
Catherine Novak: Hi, good afternoon, congrats on the progress really exciting stuff happening with Sildenafil cream.
Speaker Change: I'm just curious you know.
Speaker Change: Theyre a precedent that we can look at for simultaneous five weekly IV compounding and running on F. D. A phase III study and how do you intend to balance the commercial population with the population targeted for phase III at the moment.
Speaker Change: Great question, and so we are aware of some precedence.
Speaker Change: <unk>.
Speaker Change: Not sure that remain positioned to kind of mentioned some of them here just based on things, we know, but I will say.
Speaker Change: We like to be novel [laughter].
Speaker Change: At Delray and be innovative and you know this definitely comes from that and also you know it's the time for it I think we are really stepping up to meet the time and finding ways to kind of cut through the noise right now.
Speaker Change: A path that can be taken right. It it kind of sells for three things. It enables women to have access to the formulation and the solution that people want and need it obviously creates a nice opportunity to accelerate revenue from this proprietary product.
Speaker Change: And that's obviously positive and it meets the demand of the health care providers and to your point there is an opportunity to do that in a way that does not compromise our ability to importantly seek an FDA approval for the treatment of this indication and we're very motivated to do that because we think that is also.
Speaker Change: Important to women and healthcare providers and so specifically.
Speaker Change: And the way that we can achieve that is a few fold one is making sure we're mindful of our pricing strategy and.
Speaker Change: And we will have more on this as the year progresses and be able to share more about this but really mindful of our pricing strategy that.
Speaker Change: Reflects our continuum of care right and allows someone to move very seamlessly from using the product today as a prescription.
Speaker Change: Available today via compounding.
Speaker Change: And then transitioning over time to an FDA approved products that would now be eligible for insurance coverage and so one is really being thoughtful about the pricing strategy too.
Speaker Change: Two it's being really thoughtful about how we collect real world evidence to support the process as I mentioned.
Speaker Change: In my prepared comments, we do believe there's a really interesting opportunity here for a first in category product like this where we're blazing the regulatory path to also utilize real world evidence and real world experience.
Speaker Change: To support actually the registration process and and you know the agencies moving in an interesting direction with some guidance draft guidance document around real world evidence.
Speaker Change: And then in addition, there are obviously things that we just want to be thoughtful of in terms of the conduct of our clinical trial right. So why participate in a placebo controlled trial, we have a risk of getting placebo. When you could just be getting the prescription today from your health care provider, but that can also be managed very thoughtfully by ensuring there is oh.
Speaker Change: <unk> label extension right, so a really nice opportunity for women to both help move the field of science.
Speaker Change: For their indication from which they are suffering but also have access for sure to the product for free for a period of time and so those are our key considerations right is making sure we're being really thoughtful on the regulatory side, which we are being very thoughtful in terms of our pricing strategy that ensures that continuum of care.
Speaker Change: It is very seamless for the health care provider and the woman and then third just thoughtful around structure of the phase III.
Speaker Change: Trial and operations of the study to ensure there's a motivation to participate in that when the product is already available.
Speaker Change: Got it.
Speaker Change: That makes sense and.
Speaker Change: On the over Preen front.
Speaker Change: Obviously, you know understanding.
Speaker Change: Why.
Speaker Change: We're not going to we're not going to be able to see enrollment at the.
Speaker Change: Alright recruitment the SEC Tien site, but.
Speaker Change: Thinking about the interim readout is this something where are.
Speaker Change: Are we going to be seen.
Speaker Change: Safety, primarily or some efficacy and how is the efficacy you expect it to be different at a six month look versus 12 months.
Speaker Change: Yeah. So the D F N B's mandate is really around safety.
Speaker Change: Right, that's really their their mandate.
Speaker Change: And.
However, obviously, our pregnancy contraceptive studies actually technically an adverse event right. So it doesn't safety mandate, but obviously they will.
Speaker Change: They are privy to kind of all relevant data.
Speaker Change: As part of their meeting, but safety is really the mandate of the DSM B is to look at the data from a safety perspective.
Speaker Change: And I've mentioned this before and I think it's worth highlighting again.
Speaker Change:
Speaker Change: Contraceptive studies.
Speaker Change: Studies have demonstrated over the years that whenever there is an opportunity to look at a contraceptive effect at kind of a six month time point versus a 12 month time points.
Speaker Change: The effectiveness rates always get better over time, and that's definitely been an important consideration for us and for our collaborator Bayer.
Speaker Change: As we think about you know looking at and any interim time point in the study and what that might mean.
So in terms of what you know what you should expect is obviously, we'll give an update that the DSM b.
Speaker Change: As happened, but in efficacy evaluation is not the focus of the D. SMB meeting its really its a data safety monitoring board meeting.
Speaker Change: Okay got it thanks for the clarification.
Alright, thanks, so much for taking my question Yeah.
Speaker Change: Yeah.
Speaker Change: Our next question.
Speaker Change: Comes from Douglas Tsao from H C Wainwright.
Got it.
Speaker Change: Hi, good afternoon, thanks for taking the questions.
Speaker Change: I guess Sabrina on the.
Speaker Change: Compounding strategy.
Speaker Change: I'm just curious how do you identify the partner that you anticipate working with or have you finalize that war.
Speaker Change: Have you are you still going through a process. I think you said you are going to announce it in Q2, how much I guess starts tomorrow.
Speaker Change: And I'm just curious from a.
Speaker Change: Promotion standpoint.
Speaker Change: How is this different than if you have an FDA approved product.
Doug: Yeah, two two fantastic question. Thank you Doug So first of all on the first.
Speaker Change: <unk>.
Speaker Change: I hope as you can expect we wouldn't be comfortable making this announcement today, if we didn't.
Speaker Change: Have great strides in place in terms of.
Speaker Change: All of the regulatory guidance, which kind of goes to Catherine's question, obviously about the dual path approach and really sort of validating that but also importantly to your point on feeling confident that we have a trusted <unk> outsourcing facility option.
Speaker Change: So we felt it was very important too to make light of this you know really announced and put out in the open. This this strategy today, given how far along we are in this process, but you.
Speaker Change: You will hear more.
Speaker Change: As we get into the second quarter around the partnerships to support it.
Speaker Change: But rest assured that obviously, that's something that we have spent time evaluating before we would even make this announcement today and ensuring that we have that trusted partner for supply.
Speaker Change: And then while enhancing that I already forgot your second second half of your question.
Speaker Change: Just to round. This yes promotion, yes, whats the difference which is a fantastic question and something that we've spent.
Speaker Change: A lot of time, working again with our fantastic regulatory law firm that we utilize to I understand right the rules and regulations around five or three b versus.
Speaker Change: An FDA approved product and and really the difference.
I think theres kind of two main differences to think about one is that <unk> products are not any compounded product by the three a or b.
Speaker Change: And they're different.
Speaker Change: Are not eligible for health insurance coverage and so women would be paying out of pocket pocket. They can use their health savings that the FSA plans.
Speaker Change: Usually to support that but they are not eligible for <unk>.
Speaker Change: Insurance plan coverage. So that's definitely a difference from the promotion side, it's really around.
Speaker Change: Claims right, we want to pursue the indication.
Speaker Change: For the treatment of female sexual arousal disorder, because until you have an indication.
Speaker Change: That indication is what allows you to make those treatment claims right youre, claiming safety and efficacy in a particular population.
Speaker Change: You have an indication statement.
Speaker Change: That indicates that you indicated for the treatment of female sexual arousal disorder in.
Speaker Change: Premenopausal women right and that is what we're very interested in seeking so there is the validation of that for our health care providers and their patients and theres the opportunity for insurance coverage.
Speaker Change: And there's the opportunity to make that treatment claim.
Speaker Change: But in terms of otherwise and promotion obviously there has been a lot.
Speaker Change: That has been completed importantly, with this formulation.
Speaker Change: We are absolutely you know.
Speaker Change: Allowed under kind of regulatory compliance rules.
Speaker Change: Loud to make sure that health care providers and women are aware of so obviously the fact that toxicology studies have been completed the Factset pharmacokinetic profile has been established the fact that Pharmacodynamic profile has been established in terms of you know we've established that it actually improves blood flow through the <unk>.
Speaker Change: Temperature to show that we can absolutely provide the placebo controlled clinical study.
Speaker Change: Reprints right, we can point to it's good manufacturing practices. We can talk about who we are as a company right, where a pharmaceutical company developing this product. This isn't a marketing brand right, where a rigorous scientific driven company. We can talk about the investment that's been made to date.
Speaker Change: Into the product and importantly, we can also provide them information about disease, we can provide information about the disease state.
Speaker Change: Female sexual arousal disorder, and really understanding all of this Doug and hearing.
Speaker Change: Really since last summer since our publication came out with the findings.
Speaker Change: <unk> been hearing more and more.
Speaker Change: The medical community wanting this option and not understanding why we couldn't make it available and so you know.
Speaker Change: We're really proud of what we've done at Dore to kind of step up and take action.
Speaker Change: To accelerate the availability so that people can habit and.
Speaker Change: And have it be available while we're continuing to pursue.
Speaker Change: The FDA approval for treatment, so hopefully that helps give a little more context on.
Speaker Change: You know there's a lot of information that can be made available and and we're really happy about that again, because it's important for people to have options and clear information about what they are and that they're backed by science.
Speaker Change: Okay, great. Thank you.
Speaker Change: Absolutely.
Speaker Change: Our next question comes from Ken.
Speaker Change: Tim Gallagher for Brookline capital markets. Please go ahead.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: <unk>.
Speaker Change: Yeah, just to build on the questions regarding small organic milk.
Speaker Change: You'll be sworn in the world are models that are out there and I'm thinking it would be.
Speaker Change: And then you also have the full data filled for men.
Speaker Change: Yes.
Speaker Change: You will.
Speaker Change: On the reimbursement.
Speaker Change: I think the other element to this is that your partner you're essentially going to be.
Speaker Change: Uh huh.
Speaker Change: To some extent outsourcing.
Speaker Change: Building awareness and promotion with your partner.
Speaker Change: Because a lot of this.
Speaker Change: Out of pocket, it's going to be very advertising or promotion.
Speaker Change:
Speaker Change: And so yes.
Speaker Change: That's going to be one of the key criteria to Dennis here.
Speaker Change: Hi, Dan I'm flying this what I think would be it sounds like will be an exclusive partnership.
Speaker Change: Yeah. So there are couple of ways to think about it. So you know we definitely think about it as an exclusive partnership in in terms of.
Speaker Change: Who are we going to work with to manufacture this proprietary formulation right in manufacturing compounding is basically its manufacturing right. That's what compounding is so who will be our <unk> partner.
Speaker Change: Outsourcing facility to handle the manufacturing as well as the.
Speaker Change: You know the fulfillment right of the prescription which also has to happen to the 500 <unk>.
Speaker Change: There is though nonetheless, an opportunity for us.
Speaker Change: And actually through the K O L community, the healthcare provider community to provide education about the product and support that through education.
Speaker Change: About the disease about our formulation some of the things I just outlined in terms of what is known about our formulation what is unique about our formulation.
Speaker Change: What's been evidenced to date and scientific resources available about the formulation. So we will definitely leverage that provider to provider.
Speaker Change: Opportunity around this product as I mentioned, because it's the healthcare community that.
Speaker Change: Really in large part is what triggered this to happen for US right is that that interest and that excitement about our product coming from an organization like Dore that is a very trusted pharmaceutical developer as the only.
Speaker Change: To our knowledge publicly traded company working broadly in women's health. There are a lot of health care providers that we have been working with across multiple programs. So there's a lot of support and interests. There to your point as you pointed out with some of these other examples. We're also really interested in meeting women, where they are today, where are people getting their health care treatment options today, primarily <unk>.
Speaker Change: Lot of it is online right through telehealth and through telehealth providers.
Speaker Change: And you know we want to kind of rise to the moment and also.
Speaker Change: Average that so more to follow on all the ways that to your point, we wanted to make sure women. No. This is available in all the resources available to us to do that.
Speaker Change: I think the important thing to understand and think about it is that we have an opportunity to do this in a way that is definitely kind of fiscally responsible for ourselves and our shareholders in terms of what our investment upfront needing to do this.
Speaker Change: In a way that then we can really focus on.
Speaker Change: The financial impact of the positive financial impact to Dore, and then not reinventing the wheel right. Our idea is to.
Speaker Change: To leverage existing platforms, and again telehealth solutions to meet women, where they are today and where theyre looking today for solutions for for this but to make sure that our seat NFL cream.
Speaker Change: Is an option for them and it's not right now obviously.
Speaker Change: Right.
Speaker Change: Yeah.
Speaker Change: Given that you have data you would be.
Speaker Change: You'd be exclusive to the market.
Speaker Change: This would not be a generic situations.
Speaker Change: That's right.
Speaker Change: Yeah, that's a really important thing to understand and obviously, we've had time to kind of really delve in and understand but.
Speaker Change: A compounded product it's not the same as a generic product a generic product is when there is already an FDA approved option that is no longer under regulatory exclusivity or intellectual property patent exclusivity and someone who has filed right in and two to have that generic be available a compounded product is really for this circumstance.
Speaker Change: <unk> right. When there is no FDA approved medication that meets the needs of the health care providers and the patients.
Speaker Change: Either.
Speaker Change: You know not approved at all are not approved in the dosage form and.
Speaker Change: And so that's where this fits very nicely in terms of being a being a solution and we definitely to our knowledge as I noted already are the only only.
Speaker Change: So then if youll cream that could possibly make they.
They have completed all of the things that we've done have made the statements that we can make around this formulation and I want to stress again, that's why the healthcare provider community has has been so interested in us making this available to meet the demand there having from their patients, but they really want a trusted source.
Speaker Change: That they can count on for <unk>.
Speaker Change: The product is.
Speaker Change: It's going to be the same every time rates are manufactured under GMP, where you've got that quality.
Speaker Change: Standard that's a requirement in a facility that meets all those FDA standards.
Speaker Change: And that they know.
Speaker Change: They can trust they know has been studied.
Speaker Change: Great. Thank you.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: That concludes the question and answer session.
Speaker Change: I turn the call back over to Sabrina Martucci Johnson for any additional or closing remarks.
Speaker Change: Thank you so I want to thank you all for taking the time. This afternoon to hear about the recent updates in our ongoing commitment to drive value for all of our stakeholders by accelerating innovation in women's health and as I've talked about a few times use utilizing all of the available pathways to bring to market innovative evidence based.
Speaker Change: <unk> is designed to provide additional choices and ease of use for women and as you heard today, we continue to make great progress and with our unique model. We believe we are well positioned to accelerate innovation for women, while also driving value for all of our stakeholders. We look forward to keeping you updated on our progress and thank you for your time today.
Speaker Change: <unk>.
Speaker Change: This concludes the meeting you may now disconnect.
Speaker Change: [music].