Q1 2024 Dare Bioscience Inc Earnings Call

Operator: Welcome to the conference call hosted by Dare Bioscience to review the company's first quarter financial results and to provide a general business update. This call is being recorded. With us today from Dare are Sabrina Martucci Johnson, President and Chief Executive Officer, and Marty Herring-Leighton, Chief Accounting Officer. Ms. Johnson, please proceed.

Welcome to the conference call hosted by Dar a bioscience to review the company's first quarter financial results and to provide the general business update. This call is being recorded my name is Alex and I will be your operator for today with US today from Dori are Sabrina Martucci Johnson rush at it in.

Speaker Change: Chief Executive Officer, and Marty Harrying, Leighton Chief Accounting Officer, Mr. Johnson. Please proceed.

Sabrina Martucci Johnson: Thank you. Good afternoon, and welcome to the Dare Bioscience Financial Results and Business Update Call for the quarter ended March 31st, 2024. Today we'll review our first quarter results and discuss developments and expectations from our pipeline and portfolio. I would like to remind you that today's discussion will include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Speaker Change: Thank you good afternoon, and welcome to the di Bioscience financial results and business update call for the quarter ended March 31st try 24 today, We'll review our first quarter results and discuss developments in expectations from our pipeline and portfolio.

Sabrina Martucci Johnson: Any statements made during this call that are not statements of historical fact should be considered forward-looking statements. However, actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties.

Marty Harrying: I would like to remind you that today's discussion will include forward looking statements within the meaning of the federal Securities laws, which are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of 1995.

Marty Harrying: Any statements made during this call that are not statements of historical facts should be considered forward looking statements.

Speaker Change: Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties.

Sabrina Martucci Johnson: 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 under March 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, May 14, 2024. DARI undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

Speaker Change: 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 ended March 31, 2024, which was filed today.

Speaker Change: I would also like to point out that the content of this call includes time sensitive information that is current only as of today may 14th 2024.

Speaker Change: Sorry undertakes no obligation to update any forward looking statements to reflect new information or developments. After this call except as required by law.

Sabrina Martucci Johnson: Before we begin today's update, I'd like to take a minute to remind those of you who may be newer to the Dare story of our purpose and mission. We believe Dare is the only publicly traded company focused solely on women's health and pharmaceutical product development broadly, 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. Our commitment and focus is to improve health outcomes and the lives of women by leveraging the basic science and pharmacology that is understood about certain active pharmaceutical ingredients and marketed products to accelerate innovative treatments that women want and need by boldly addressing existing therapeutic gaps.

Dar: Before we begin today's update I'd like to take a minute to remind those of you who may be newer to the Dar a story of our purpose and mission. We believe di is the only publicly traded company focused solely on women's health pharmaceutical product development broadly and we remain dedicated to advancing disruptive products for the.

Speaker Change: The health and wellbeing of women through clinical development regulatory review and ultimately to market.

Dar a: Our commitment and focus is to improve health outcomes and the lives of women by leveraging the basic science and pharmacology that is understood about certain active pharmaceutical ingredients and marketed products to accelerate innovative treatments that women want and need by boldly addressing existing therapeutic gaps.

Speaker Change: Yes.

Sabrina Martucci Johnson: We seek to optimize these treatments for our target indications to enhance outcomes, convenience, and side effect profile, or to address a novel indication where the pharmacology is well suited, but has not been previously applied to the indication in question for women. We believe we have assembled the broadest portfolio of potential high-impact, first-in-category product candidates, many of which have already demonstrated proof of concept, and that our robust pipeline positions us well for the short, medium, and long term.

Speaker Change: We seek to optimize these treatments for our target indications to enhance outcomes convenience and side effect profile or to address a novel indication where the pharmacology is well suited but has not been previously applied to the indication in question for women.

Speaker Change: We believe we have assembled the broadest portfolio of potential high impact first in category product candidates, many of which have already demonstrated proof of concept and that our robust pipeline positions us well for the short medium and long term.

Sabrina Martucci Johnson: On our recent full year 2023 financial results and update call, we discussed the strides we made last year to advance innovative therapies for women and the key milestones anticipated for 2024. So today, in addition to the continued commercialization by our collaborator Organon of Zasciato Clindamycin Phosphate Vaginal Gel 2%, the first FDA-approved product to emerge from our portfolio and a treatment for bacterial vaginosis in females age 12 and older that's now available by prescription nationwide.

Speaker Change: At our recent full year 2023 financial results and update call. We discussed the strides we made last year to advance innovative therapies for women and the key milestones anticipated for 2024.

Speaker Change: So today in addition to the continued commercialization by our collaborator, Oregon aren't Zasyadko clindamycin phosphate Bachelor gel, 2%. The first FDA approved product to emerge from our portfolio and a treatment for bacterial vaginosis and female age 12 and older. That's now available by prescription nationwide.

Sabrina Martucci Johnson: On that last call, we discussed anticipated 2024 milestones focused on our first in category product candidates relating to continued progress toward a phase three clinical trial of sidenafil cream 3.6% in female sexual arousal disorder for which there are no FDA-approved treatments, and enrollment in our Phase 3 study of oviprene, which could be a first in category hormone-free monthly intravaginal contraceptive candidate. Today we're going to cover our first quarter 2024 accomplishments, as well as some important recent highlights, including the $22 million non-dilutive strategic royalty financing we announced a couple weeks ago.

Speaker Change: On that last call. We discussed anticipated 2024 milestones focused on are first in category product candidates relating to continued progress toward a phase III clinical trial of a sedan. They feel crane three 6% in female sexual arousal disorder for which there are no FDA approved treatments.

Speaker Change: And enrollment in our phase III study of overpaying or potentially first in category hormone free monthly Intravascular contraceptive candidate.

Speaker Change: Today, we're going to cover our first quarter 2024 accomplishments as well as some important recent highlights, including the 22 million non dilutive strategic royalty financing, we announced a couple of weeks ago will also review our progress against the anticipated 2024 milestones providing com.

Sabrina Martucci Johnson: We'll also review our progress against the anticipated 2024 milestones, providing context and metrics that are important to our current and future shareholders, with a focus on those phase three candidates, Obiprene and Sildenafil cream. But before I do, I'm going to first turn it over to our Chief Accounting Officer, Marty, to review our first quarter financial results.

Sildenafil cream: On tax and metrics that are important to our current and future shareholders with a focus on those phase III candidates <unk> and Sildenafil cream.

Sildenafil cream: Before I do I'm going to first turn it over to our Chief Accounting Officer, Marty to review, our first quarter financial results.

Marty Herring-Leighton: Thanks, Sabrina. And thanks, everyone, for joining us today. I would now like to summarize Dare's financial results for the quarter-ended March 31, 2024, which I will refer to as the first quarter. As Sabrina mentioned, Dare's business strategy is to assemble and advance a portfolio of differentiated product candidates that address meaningful unmet needs we've identified in women's health, and then to monetize the value of our portfolio's clinical and regulatory advances over the near and long term. The investment required to build and advance a portfolio includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development, or R&D expenses.

Sildenafil cream: Sabrina and thanks, everyone for joining us today I would now like to summarize <unk> financial results for the quarter ended March 31, 2024, which I will refer to as the first quarter as Sabrina mentioned various business strategy is to assemble and advance a portfolio of differentiated product candidates that address meaningful unmet needs we've identified and.

Marty Herring-Leighton: During the first quarter of 2024, our general and administrative expenses were approximately $2.7 million. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory, and other R&D activities across our entire portfolio, were approximately $3.3 million for the first quarter, which is a 34% decrease compared to Q1 2023. Closeout costs related to the Phase 2b RESPOND clinical study of sildenafil cream and other clinical studies conducted in 2023 contributed significantly to our first quarter R&D expenses, which will not be the case in future quarters. Until we commence a Phase 3 clinical study of sildenafil cream, we expect R&D expenses for future quarters to be lower than our first quarter R&D expenses. Our comprehensive loss for the quarter was approximately $6.8 million.

Sabrina: Women's health and then to monetize the value of our portfolio of clinical and regulatory advances over the near and long term 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.

Sabrina: During the first quarter of 2024 of general and administrative expenses were approximately $2 $7 million or R&D expenses, which vary from period to period based on clinical preclinical manufacturing regulatory and other R&D activities across our entire portfolio were approximately $3 $3 million for the first quarter.

Sildenafil cream: Which is a 34% decrease compared to Q1 2023 closeout costs related to the phase two be respond clinical study of Sildenafil cream and other clinical studies conducted in 2023 contributed significantly to our first quarter R&D expenses, which will not be the case in future quarters until we commence a still.

Speaker Change: <unk> cream phase III clinical study, we expect R&D expenses for future quarters to be lower than the first quarter R&D expenses.

Speaker Change: Our comprehensive loss for the quarter was approximately $6 $8 million. We ended the first quarter with approximately $3 6 million in cash and cash equivalents and had approximately 101 million shares of common stock outstanding as of May 13th.

Marty Herring-Leighton: We ended the first quarter with approximately $3.6 million in cash and cash equivalents and had approximately 101 million shares of common stock outstanding as of May 13. We recently announced a royalty monetization transaction with Zoma, in which Dare received $22 million in gross proceeds, and following a pre-specified total return to Zoma, Zoma will make upside sharing milestone payments to Dare equal to 50% of all remaining cash flows sold to Zoma under the transaction.

XOMA: We recently announced a royalty monetization transaction with XOMA, and which <unk> received $22 million in gross proceeds and following a pre specified total return to XOMA XOMA will make upside sharing milestone payments to dara equal to 50% of all remaining cash flow sold to XOMA under the transaction.

Marty Herring-Leighton: This monetization of future net royalty and net milestone payments accelerates potential cash flows from the future commercial success of Zashiato and ensures that Dare and our shareholders have the opportunity to participate meaningfully in Zashiato economics as commercialization progresses. This non-dilutive financing provides significant capital to help achieve our objectives and importantly allows us to focus on advancing our Phase 3 investigational products Ovapreen and Sildenafil Cream, both of which represent large market, first in category opportunities.

Speaker Change: This monetization of future net royalty and milestone payments accelerates potential cash flows from the future commercial success of loss shadow It ensures that Dara and our shareholders have the opportunity to participate meaningfully in Sochi auto economics as commercialization progressive.

Dara: This non dilutive financing provides significant capital to help achieve our objective and importantly allows us to focus on advancing our phase III investigational products overprint unfilled NFL cream.

Dara: Both of which represent large market first in category opportunities.

Marty Herring-Leighton: The structure of this transaction also underscores the significant potential of Overcreen and Sildenafil cream with Dare retaining a significant majority of future economics and the ability to achieve attractive margins through retained net sales and all commercial milestones. In addition to this funding, we received total grant funding of approximately $1.8 million in January and April under our grant agreements with the Foundation in support of our investigational contraceptive, DARE-LARP1, and to fund activities related to bacteria-based live biotherapeutic product development.

Speaker Change: The structure of this transaction also underscores the significant potential.

Dara: <unk> and <unk>, which are a retaining the significant majority of future economics, and the ability to achieve attractive margins through retained net sales in all commercial milestones.

Speaker Change: In addition to this financing we received total grant funding of approximately $1.8 million in January and April under our grant agreements with a foundation in support of our investigational contraceptive Dare <unk>, one and to fund activities related to bacteria based live biotherapeutic product development.

Marty Herring-Leighton: DARA may receive up to a total of approximately $49 million under our grant agreement relating to DERLARC-1 to advance the development of DERLARC-1 through non-clinical proof of principle studies and other work to prepare for the submission of an investigational new drug application with the FDA, approval of which is required to begin testing in humans. To date, DARA has received approximately $29.4 million under the DERLARC-1 grant agreement. Together, the royalty financing and latest installment in grant funding represent our commitment to being creative, collaborative, and opportunistic in seeking the capital needed to meet our objectives and to build shareholder value.

Barry: Barry may receive up to a total of approximately $49 million under our grant agreement relating to Darryl arc won two advanced development of <unk>, one through non clinical proof of principle studies and other work to prepare for the submission of an investigational new drug application with the FDA approval of which is required to begin testing in humans.

Barry: To date Dara has received approximately $29 $4 million under the <unk> Grant agreement.

Dara: Together, the royalty financing and latest installment in grant funding represent our commitment to being creative collaborative and opportunistic in seeking the capital needed to meet our objectives and to build shareholder value.

Marty Herring-Leighton: We encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, and risk factors in our quarterly report on Form 10-Q for the quarter ended March 31st, 2024, which we filed this afternoon, as well as in our annual report on Form 10-K for the year ended December 31st, 2023, which was filed on March 28th, 2024. I would now like to turn the call back over to Sabrina. Thank you, Marty.

Dara: We encourage investors to review the more detailed discussion of our financials, our financial condition liquidity capital resources and risk factors in our quarterly report on Form 10-Q for the quarter ended March 31, 2020 for which we filed this afternoon as well as in our annual report on Form 10-K for the year ended December 31 2020.

Sabrina: Three which was filed on March 28, 2024, I would now like to turn the call back over to Sabrina. Thank you Marty.

Sabrina Martucci Johnson: I'm now going to talk through our first quarter 2024 accomplishments and some anticipated 2024 milestones, with a focus on our phase 3 assets, the Denafil cream and Ovapreen. But first, I'll provide an update on our on-market assets, Zosciato, Clindamycin, Phosphate, Vaginal Gel 2%, or just Zosciato. As a reminder, Tsao' 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.

Sabrina: And now I'm going to talk through our first quarter 2024 accomplishments and some anticipated 2024 milestones with a focus on our phase III assets at NFL cream and overpaying, but first I'll provide an update on our on market assets Shadow clindamycin phosphate vaginal gel, 2% or just das shadow.

unknown: As a reminder, <unk> shadow is indicated for the treatment of bacterial Vaginosis and females 12 years of age and older. 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 in.

Sabrina Martucci Johnson: In the first quarter of 2024, through our commercialization agreement with Organon, Zasciato became available by prescription across the United States. The Oregon Women's Health Sales team continues to see strong acceptance from clinicians who have tried multiple uses of Zasciato with their patients. This progressive ramp-up of trial from key health care provider targets continues to build momentum as we move through the first full year of launch. I'll now talk about sidenafil cream, 3.6%.

Oregon Zasyadko: The first quarter of 2024 through our commercialization agreement with Oregon on Saar Shadow became available by prescription across the United States.

Speaker Change: The Oregon on women's health sales team continues to see strong acceptance from clinicians who have tried with their patients multiple uses of <unk> in their practice.

Speaker Change: This progressive ramp up of trial from key health care provider targets continues to build momentum as we move through the first full year of launch.

Sabrina Martucci Johnson: During the first quarter, we also announced the successful completion of an end to phase two meeting with the FDA on the development of sidenafil cream as a treatment for female sexual arousal disorder. In terms of market and revenue potential, there are currently no FDA-approved treatments for any form of sexual arousal disorder in women, meaning sidenafil cream has the potential to be the first. Sidenafil is the active ingredient in tablet form for oral administration currently marketed under the brand name Viagra for the treatment of erectile dysfunction in men, which was undoubtedly one of the most successful prescription products ever launched.

Speaker Change: Okay.

Speaker Change: I will now talk about to the NFL Crane three 6% during the first quarter. We also announced the successful completion of an end of phase two meeting with the FDA on the development of Sudan is a cream as a treatment for female sexual arousal disorder and.

NFL Crane: In terms of market and revenue potential there are currently no FDA approved treatments for any form of sexual arousal disorder in women, meaning <unk> cream has the potential to be the first.

Market researcher: So then it fills the active ingredient in tablet form for oral administration currently marketed under the brand name Viagra for the treatment of erectile dysfunction in men, which wasn't out every one of the most successful prescription products ever launched market research suggests that approximately 20 million women in the United States.

Sabrina Martucci Johnson: Market research suggests that approximately 20 million women in the United States experience symptoms of low or no sexual arousal. In terms of probability of success, we've already demonstrated that sodenophilcrene increased genital tissue blood flow in quantitative studies. And as we most recently shared during our full year 2023 results call, we also completed all study analyses of data from the exploratory phase to be the respond clinical study of sodenophilcrene. The patient population and the endpoints identified in the phase 2b study and proposed to the FDA for phase 3 clinical development were those where post hoc analyses of the phase 2b study data showed that sildenafil cream demonstrated both statistically significant and meaningful patient improvement.

NFL Crane: Symptoms of low or no sexual arousal.

Speaker Change: In terms of probability of success, we've already demonstrated that seat NFL crane increase genital tissue blood flow and quantitative studies and as we most recently shared during our full year 2023 results call. We also completed all study analyses of data from the exploratory phase <unk> respond clinical study.

NFL Crane: Absolute NFL crane.

Speaker Change: The patient population and the endpoints identified in the phase <unk> study and proposed to the FDA for phase III clinical development.

unknown: Those were post hoc analyses of the phase <unk> study data showed that <unk> cream demonstrated both statistically significant and meaningful within patient improvement.

Sabrina Martucci Johnson: We are continuing to interact with the FDA as the agency reviews specifically the data generated on the proposed endpoints to take forward into Phase 3 development. The FDA has indicated that it anticipates providing additional feedback during this second quarter on the Phase III design, which would be the first-ever Phase III pivotal study of a therapeutic candidate for the treatment of arousal disorder in women. We look forward to providing updates on the FDA's feedback, phase three study design and plans, as well as any relevant updates on our collaboration strategy as they become available this year.

FDA: We are continuing to interact with the FDA as the agency reviews, specifically the data generated on the proposed to endpoints to take forward into phase III development.

FDA: The FDA has indicated that it anticipates, providing additional feedback during this second quarter on the phase III design, which would be the first ever phase III pivotal study of a therapeutic candidate for the treatment of arousal disorder in women.

FDA: We look forward to providing updates on the FDA feedback phase III study design and plans as well as any relevant updates on our collaboration strategy as available this year.

Sabrina Martucci Johnson: And now to end, We also want to provide an update on the Phase 3 study of Opaprene, which is our novel, investigational, hormone-free, monthly, intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer. Non-hormonal contraception represents a significant commercial market opportunity, and there are currently no monthly hormone-free contraceptives approved by the FDA. Overpraying has the potential to be a disruptive product in the contraceptive category and an important option for women who cannot use hormone-based birth control products or prefer not to do so.

FDA: And now to <unk>.

Speaker Change: We also want to provide an update on the phase III study of <unk>, which is our novel investigational hormone free monthly intra vaginal contraceptive.

Speaker Change: Whose U S commercial rights are under a license agreement with Bayer.

Bayer: Non hormonal contraception represents a significant commercial market opportunity and there are currently no monthly hormone free contraceptive approved by the FDA.

Bayer: <unk> has the potential to be a disruptive product in the contraceptive category and an important option for women, who cannot use hormone based birth control products or prefer not to do so.

Sabrina Martucci Johnson: Based on market research, approximately 35 million women in the US are potential candidates for oviparine. Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, of the National Institute of Health, or NIH, we commenced patient enrollment in the Oviprene Pivotal Phase III clinical study in December 2023. Recruitment is currently underway at 18 sites across the United States and is supported by a central advertising campaign for the study that launched in March of this year. You can find a link to the campaign materials by visiting our homepage.

Speaker Change: Based on market research approximately 35 million women in the U S are potential candidates for <unk>.

Speaker Change: Working with steady collaborators at the Eunice Kennedy Shriver National Institute of Child, Health, and human development or Nics D of the National Institute of health or NIH, we commenced patient enrollment in the evergreen pivotal phase III clinical study in December 2023.

Speaker Change: Recruitment is currently underway at 18 sites across the United States and is supported by a central advertising campaign for the study that launched in March of this year.

Speaker Change: You can find a link to the campaign materials by visit by visiting our website homepage, we were thrilled to see how many women responded immediately to our call to join the hormone free Revolution. When we launched the campaign in March.

Sabrina Martucci Johnson: We were thrilled to see how many women responded immediately to our call to join the hormone-free revolution when we launched the campaign in March by checking if they qualified to participate in the study. We plan to provide updates on the anticipated timing for study completion, which involves 12 months of product use, as enrollment progresses, and will also provide recruitment and any relevant data updates in the coming quarters. Based on communications to date with the FDA, if successful, we believe that just the single registration study will be required to support a premarket approval application with the FDA.

Speaker Change: <unk> checking if they qualified to participate in the study.

Speaker Change: We plan to provide updates on anticipated timing for study completion, which involves 12 months of product to use as enrolment progresses and will also provide recruitment and any relevant data updates in the coming quarters.

Speaker Change: Based on communications to date with the FDA. If successful we believe that just the single registration study will be required to support our pre market approval application submission with the FDA.

Sabrina Martucci Johnson: And lastly, we announced in the first quarter that we achieved technological proof of concept for our preclinical candidate that Marty was talking about earlier, Dare Lark One, and importantly, for its underlying innovative drug delivery platform, which is designed to store and precisely deliver therapeutic doses of drugs over months or years through a single implanted device. This milestone reflects the drug delivery platform's transformative potential in not only women's health but also in various conditions outside of women's health where treatment requires frequent dosing or regular injections.

Marty: And lastly, we announced in the first quarter that we achieve technological proof of concept for our preclinical candidate that Marty was talking about earlier <unk>, one and importantly for its underlying innovative drug delivery platform, which is designed to store and precisely deliver therapeutic dose.

Marty: This is a drug over months or years through a single implanted device.

Marty: This milestone reflects the drug delivery platforms transformative potential in not only women's health, but as well as various conditions outside of women's health, where treatment requires frequent dosing our regular injections.

Sabrina Martucci Johnson: We are developing the DARE-LARC1 implant, which utilizes this proprietary drug delivery platform as a user-controlled, long-acting, reversible contraceptive solution designed to combine the benefits of long-acting, reversible contraceptives with the flexibility of shorter-acting methods. But we see the potential of this drug delivery platform technology to transform treatment for certain other chronic conditions as well. With this milestone, we are excited to begin strategic discussions with pharmaceutical companies working to address chronic conditions such as diabetes, obesity, and other conditions requiring precise and prolonged treatment, leveraging the platform's potential to precisely deliver a wide array of active pharmaceutical ingredients over longer durations with a lower burden for patients.

Marty: We are developing the <unk> implant, which utilizes proprietary drug delivery platform as a user controlled long acting reversible contraceptive solution designed to combine the benefits of long acting reversible contraceptive with the flexibility of shorter acting methods, but we see the potential.

Speaker Change: All of this drug delivery platform technology to transform treatment for certain other chronic conditions as well. So with this milestone we are excited to begin strategic discussions with pharmaceutical companies working to address chronic conditions, such as diabetes obesity and other conditions requiring precise.

Marty: And prolonged treatment leveraging the platform's potential to precisely deliver a wide array of active pharmaceutical ingredients over longer durations with a lower burden for patients and as Marty mentioned earlier current development of <unk>. One implant technology is supported by an up to $49 million Foundation Grant.

Sabrina Martucci Johnson: And as Marty mentioned earlier, the current development of DARE-LARC1 implant technology is supported by an up to $49 million foundation grant. Dare Lark One and our other grant-funded product candidates; they enhance our portfolio, and we look forward to providing relevant updates on Dare Lark One and the other ongoing grant-funded programs as relevant this year. So, in summary, we're excited about the progress we've made this year and are looking forward to providing more updates as we work to advance some of the most potentially disruptive candidates for the health and well-being of women in decades, collaborating with leading companies, including Organon for Zasciato and Bayer for Ovaprene, to commercialize and deliver these treatments to as many women as possible. So I'd now like to turn the call over to the operator for Q&A.

Marty: <unk>, one and our other grant funded product candidates they enhanced our portfolio and we look forward to providing relevant updates on <unk>, one and the other ongoing grant funded programs as relevant this year.

Marty: So in summary, we're excited about the progress we've made this year and are looking 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 organizers or shadow and bear for Overtrain to commercialize and deliver these.

Speaker Change: Treatment to as many women as possible.

Operator: So I'd now like to turn the call over to the operator for Q&A.

Operator: Thank you, Sabrina. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again. If you are called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. Again, press star 1 to join the queue. When your first question comes from the line of Douglas Tsao with H.E. Wainwright, please go ahead.

Operator: Thank you Sabrina we 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 to raise your hand and joined the queue. If you would like to withdraw your question simply press Star. One again, if you are called upon to ask your question and our listening via loudspeaker.

Operator: On your device lease pick up your handset and ensure that your phone is not on mute when asking your question again press star one to join the queue and your first question comes from the line of Douglas Tsao with H C. Wainwright. Please go ahead.

Douglas Dylan Tsao: Hi, good afternoon. And thanks for taking the questions. I guess, Sabrina, you're looking now for some additional feedback from FDA on sidenosal cream. Can you just maybe help us walk through some of the steps that would be needed to initiate that phase three? Thank you.

Douglas Dylan Tsao: Hi, good afternoon, and thanks for taking my questions I guess Irina you're looking now for some additional feedback from FDA on sedan also cream I mean can you just maybe help us walk through some of the steps that would be needed to initiate that phase III. Thank you yeah.

Sabrina Martucci Johnson: Yeah, Doug, thanks. Great question. So, yes, as I mentioned, we're waiting for some feedback so that we can, you know, make sure we're aligned on the final phase through design and the endpoints for that, and important things like endpoint hierarchy and all of that, but to your question, what we're trying to do is make sure that all of the other activities that are required to start up a clinical trial are being done.

Doug: Yeah, Doug Thanks, Great question. So, yes, so as I mentioned, where we're waiting for some feedback so that we can make sure. We're aligned on the final phase III design.

Doug: The endpoints for that and important things like endpoint hierarchy, and all of that but to your question. What we're trying to do is make sure that all of the other activities that are required to startup a clinical trial.

Speaker Change: That we're doing everything we can to make sure that we are ready. So those activities include things such as.

Sabrina Martucci Johnson: We can to make sure that we are ready. So those activities include things such as, you know, selecting your CRO, right? And having your study budget and materials in place. You know, making sure we have a clear line of sight into the sites that we want to use. Now, obviously, we had the experience of the phase 2B study, so that's helpful in terms of selecting sites because we know the sites we used in that study and who we want to continue, but just making sure we're ready from that regard, making sure that we're ready with clinical supplies, materials, right, the investigational product, and placebo to test in the trial.

Speaker Change: Selecting your sciarra, right and having your study budget and materials in place.

Speaker Change: Making sure we have a clear line of sight into these sites that we want to use now obviously, we had the experience of the phase <unk> study. So thats helpful. In terms of selecting sites because we know the sites we used in that study and who we want to continue but just making sure we're ready from that regard, making sure that we're ready with.

Speaker Change: <unk> supplies materials.

Speaker Change: Right, the investigational product and placebo to test in the trial.

Sabrina Martucci Johnson: So those are the activities that are underway and that we really started earlier this year, quite frankly, and that are well underway to make sure that as soon as we get the feedback from the FDA, we are ready to move as quickly as reasonably possible to proceed, and there isn't some other, right, some other gating activity that we have not yet completed.

Speaker Change: So those are the activities that are underway and that we really started earlier this year quite frankly.

Speaker Change: We are well underway to make sure that as soon as we get the feedback from the FDA that we are ready to move as quickly as reasonable to proceed and there isn't some other Reits. Some other gating activity that we had not yet completed.

Douglas Dylan Tsao: Okay, great. That's helpful. And then maybe on overpraying, you know, maybe just help us understand when we should sort of start to think about sort of getting initial data or just the final readout from a timing standpoint.

Speaker Change: Okay, Great. That's helpful. And then just maybe on <unk>.

FDA Representative: Maybe just help us understand when we should start to think about sort of getting initial data or just the final read out from a timing standpoint. Thank you yeah, great. Yeah. Great question. So so that trial for those who may not be as familiar to the trial.

Sabrina Martucci Johnson: Thank you. Yeah. Great. Yeah. Great question.

Sabrina Martucci Johnson: So, the trial, for those who may not be as familiar, is a 12-month study, meaning the subjects in the study, our goal is to follow them, to have them use Ovapreen over the course of 12 months, and we'd like to have around 200, 250 women complete 12 months of use with the product. And so we started, as I mentioned, we started enrolling the subjects at the end of last year.

Speaker Change: Is it 12 months steady meaning the subjects.

Speaker Change: In this study our goal is to follow them to have them use overtrain.

Speaker Change: Over the course of 12 months.

Speaker Change: And and we'd like to have around 200 250 women complete.

Speaker Change: 12 months of use with the product.

Speaker Change: And so we started as I mentioned, we started enrolling the subject at the end of last year.

Sabrina Martucci Johnson: And the advertising campaign, which is important in studies like this, went live in March. And as I mentioned in my comments, we were definitely very happy with how much responsiveness we saw to the advertising campaign, which really leverages, like, as you can imagine, social media platforms to make sure people are aware of the study and can, you know, can reach out to express their interests and then matches them to sites.

Speaker Change: And the advertising campaign, which is important in studies like this it went live in March and as I mentioned in my comments, we are definitely very happy with how much responsiveness, we saw to the advertisement campaign, which really leverages like as you can imagine social media platforms to make sure people are aware of the study.

Speaker Change: <unk> and.

Speaker Change: Can can reach out to express their interest and then matches them to sites.

Sabrina Martucci Johnson: So with the ad campaign just going live in March, it's a little bit early for us to give very specific guidance, which we do want to do and give some perspective on, you know, timelines and when we expect all that. But having said that, we are very happy with how the advertising campaign has been going and the responsiveness that we're seeing to it. And the reason all of that is important, and Doug's question about the timelines is important, is because this is an open-label study, meaning everyone is single-arm. Everyone is on OVAPREAN.

Speaker Change: So with the AD campaign is going live in in March it's a little bit early for us to give very specific guidance, which we do want to do.

Speaker Change: And give some perspective on <unk>.

Douglas Dylan Tsao: Timelines and when we expect all of that but having said that we are very happy with how the advertising campaign has been going and the responsiveness that we're seeing to the advertising campaign and the reason all of that is important and in Doug's question about the timelines are important is because this is.

Douglas Dylan Tsao: An open label study, meaning everyone is single.

Douglas Dylan Tsao: Everyone is an overprint.

Sabrina Martucci Johnson: And so, obviously, having a line of sight into how enrollment is going gives us an opportunity to understand if there's an opportunity to look at interim data and when that'll happen, and when the final data will come. So, at this point, you know, what I can definitively say definitively, given that we didn't start recruiting until the end of last year, is that we certainly don't expect to have final data this year.

Douglas Dylan Tsao: And so obviously, having a line of sight into how enrollment is going.

Douglas Dylan Tsao: It gives us an opportunity to understand if there is an opportunity to look at interim data and when that will happen and when the final data will come. So at this point, what I can say definitively given that we didn't start recruiting until the end of last year is that we certainly.

Speaker Change: We don't anticipate to have final data this year.

Sabrina Martucci Johnson: You know, that wouldn't really be feasible given the timeline of the study, but we definitely hope to have some meaningful updates that we can share this year. And then, as we get a little bit further with the live enrollment and the ad campaign, we'll be able to give better guidance as to exactly when we expect the last patient out. Okay, great. Thank you so much. That's really helpful. Yeah.

Douglas Dylan Tsao: That wouldn't really be PS.

Speaker Change: These are all given the timeline that the study, but we definitely hope to have some meaningful updates that we can share. This year and then as we get a little bit further with the live enrolment with the AD campaign will be able to give better guidance as to exactly when we expect when we would anticipate last patient out.

Douglas Dylan Tsao: Okay, great. Thank you so much that's really helpful. Thank you.

Sabrina Martucci Johnson: Yeah, thank you.

Kemp Bolivar: Your next question comes from the line of Kemp Bolivar with Brooklyn Capital Markets. Please go ahead.

Douglas Dylan Tsao: Your next question comes from the line of Camp Bolivar with clean capital markets lease go ahead.

Douglas Dylan Tsao: Okay.

Kemp Bolivar: Okay, thank you. I want to ask a couple of questions regarding the balancing act now between your current funding and your plans because there's some language in the 10 Q that's pretty sobering regarding The Cash Runway, but at the same time, your current spending levels, in theory, could get you past 12 months and possibly to the overprint readout. You know, based on the step down, we'll likely see an R&D expense and the fact that you really don't have much; you have a small remaining obligation for the over pre trial. So how should we think about the spending and what we're able to get? Where you're able to get with the readouts, particularly with the Zoma financing in place. Yeah.

Douglas Dylan Tsao: Thanks.

Douglas Dylan Tsao: Hum.

Douglas Dylan Tsao: Okay.

Sabrina Martucci Johnson: Yeah, thank you. Great, great question.

Speaker Change: I wanted to ask a couple of questions regarding the.

Speaker Change: Youre balancing act now between your current funding plans because there was some language in the 10-Q, that's pretty sober.

Speaker Change: Regarding.

Speaker Change: The cash runway, but at the same time.

Speaker Change: Your current spending levels.

Speaker Change: CRE could get you.

CRE: Past 12 months and possibly to the over create readout.

CRE: Yeah.

CRE: Based on the step down will likely see an R&D expense and the fact that you really don't have much smaller.

Speaker Change: Painting obligation for the over three trials. So how should we think about the spending in wood.

Speaker Change: We were able to get.

Speaker Change: Were you able to get with Readouts.

Speaker Change: Particularly with the XOMA financing in place.

Sabrina Martucci Johnson: And so, you know, as Marty mentioned in her comments and you noted, R&D spending, until we start the Sidenafil trial, because of the nature of our arrangement on Oviprene and the funds we had already remitted to the NIH under a collaborative research agreement, as you noted, there's not a lot left that we've already committed to spend on that. There's another $500,000 payment on that. But otherwise, right, the R&D spend, as Marty noted, is significantly reduced compared to last year until we start a Sidenafil phase three study.

Speaker Change: Yeah, I think you have great great question, and so as Marty mentioned in her comments and you noted.

Marty: R&D spending until we start to Sudan infill trial because of the nature of our arrangement on Overtrain and the funds we had already remitted to the NIH under a collaborative research agreement as you noted.

Marty: Theres not a lot left that we've already committed to.

Marty: To spend on that there is another $500000 payment on that.

Marty: Otherwise raise the R&D spend as Marty noted is significantly reduced compared to last year.

Speaker Change: Until we start <unk>.

Sabrina Martucci Johnson: And as I was, you know, mentioning in the response to Doug's questions, we want to be prepared to move on that as quickly as we can. And a single phase three study, our expectations at this point, at least based on what we know today, are around 15 million. So you know, when you look at, you know, just our baseline burn, which we, you know, in our last call had provided some guidance that the expected gna this year was about 10 million for the year, right?

Doug: <unk> phase III study and as I was mentioning in that in the response to Doug's question, we want to be prepared to move on that as quickly as we can and a single phase III study.

Speaker Change: Our expectation at this point at least based on what we know today.

Speaker Change: Around $15 million.

Speaker Change: So when you look at.

Doug: Just our baseline burn, which we in our last call had provided some guidance that our expected G&A. This year was about $10 million.

Doug: For the year right. When you start to is taking all of that into consideration from R&D $22 million is absolutely impactful and to your point really gets us.

Sabrina Martucci Johnson: When you start just taking all of that into consideration, smart D 22 million is absolutely impactful. And to your point, really gets us just some very important milestones in terms of over preening, you know, progressing, opportunities potentially to look at some of that interim data, timing, and even, to your point, depending on how enrollment goes, you know, even further than that, but we want to be very clear, in our communication that a single Sidenafil trial is $15 million.

Speaker Change:

Speaker Change: Some very important milestones in terms of.

Speaker Change: Overpaying progressing.

Speaker Change: Opportunities potentially to look at some of that interim data timing and even to your point, depending on how enrollment goes.

Speaker Change: Even further than that.

Speaker Change: But we wanted to be very clear right in our communication that a single suite NFL trial is $15 million in the scheme of things is that a lot. When you think about the potential of like what viagra did.

Sabrina Martucci Johnson: In the scheme of things, is that a lot when you think about the potential of something like what Viagra did, you know, in the marketplace? No, but we do want to make sure we're being clear in our communication, given that dollar amount in relation to the $22 million.

Speaker Change: In the marketplace no, but we do want to make sure we're being clear in our communication given given that dollar amount in relation to the $22 million.

Kemp Bolivar: That's very helpful. And to be clear, does that $15 million include the activities you're engaged in now before?

Speaker Change: Great. Thank you very helpful and then to be clear.

Speaker Change: Is that $15 million include the activities you're engaged in now prior to.

Speaker Change: Initiation.

Sabrina Martucci Johnson: It does because the $15 million does include things like manufacturing, right, the cost of manufacturing the product for the clinical trials, you know, certain startup, right, site startup activities. It's what we expect the all-in number to be.

Speaker Change: It does because the $15 million does include things like manufacturing right the cost of manufacturing the product for the clinical trials.

Speaker Change: Certain startup right site startup activities.

Speaker Change: It's what we expect the all in number to be.

Kemp Bolivar: Okay, and Assuming the feedback from FDA is not surprising, and you're there, only minor hiccups along the way with preparation, when do you think is a reasonable expectation for initiating the trial? Because it looks like that early 2025 is reasonable, but maybe you can start early in 2024. Yes.

Speaker Change: Okay and.

Speaker Change: Yeah.

Speaker Change: Assuming the feedback from FDA is not surprising.

Speaker Change: There are only minor hiccups, along the way with preparation.

Speaker Change: When do you, what's your reasonable expectation for initiating the trial because it looks like.

Speaker Change: Early 2025 is reasonable, but maybe you can start early.

Speaker Change: 2024.

Sabrina Martucci Johnson: Yeah, that's definitely our hope. That's a great way to look at it, right?

Speaker Change: Yeah, that's definitely our hope that's a great way to look at it right like we're trying to just make sure that we've checked all the boxes that we can check until we have that final protocol and then being able to move as quickly as we can once we have the protocol.

Sabrina Martucci Johnson: Like we're trying to just make sure that we've checked all the boxes that we can check until we have that final protocol. And then, you know, being able to move as quickly as we can once we have the protocol. But, you know, there are startup activities, right? You got to contract with all the sites.

Speaker Change: But there.

Speaker Change: There is startup activities right you've got a contract with all the site. There are things we can't do until we have a final protocol.

Sabrina Martucci Johnson: There are things we can't do until we have a final protocol, so our intent is to move as fast as we possibly can. That's our objective. That's our goal. And so, you know, we'd love to be in a position to do that this year. But it definitely, to your point, is predicated on the timing of getting the comments back from the FDA, and, you know, and hopefully they're clear, as you noted, so that we can move very quickly. But like I said up front, we're trying to make sure that we have ticked off every other activity so that we're ready to sprint.

Speaker Change: So our intent is to move as fast as we possibly can and that's our objective that's our goal.

Speaker Change: And so you know we.

Speaker Change: We'd love to be in a position to do that this year, but it definitely to your point is predicated on timing of getting the comments back from the FDA and.

Speaker Change: And hopefully they are clear.

Speaker Change: As you noted so that we can move very quickly, but like I said upfront. We're trying to make sure that we have kicked off every other activities. So that so that we're ready to sprint.

Sabrina Martucci Johnson: Okay, and you have the flexibility to delay initiating the trial until you have, say, more certainty around your runway. Oh, absolutely. It's all within our control.

Speaker Change: Okay, and you have the flexibility to.

Speaker Change: Delay initiating the trial until you have to say.

Speaker Change: More certainty around your runway Oh, absolutely, it's all within our control right. So the things that we're doing now or are not significant in terms of expenses, but they're important activities.

Sabrina Martucci Johnson: Oh, absolutely. It's all within our control, right? So the things that we're doing now are not significant in terms of expenses, but they're important activities, you know, so that we are ready to go at our choice, right? At the timing, completely 100% at our discretion. Great, thank you. Yeah, thank you for the great question.

Speaker Change: So that we are ready to go.

Speaker Change: At our choice.

Speaker Change: Right at the timing completely 100% in our discretion.

Speaker Change: Okay.

Speaker Change: Great. Thank you.

Speaker Change: Yeah. Thank you for the great questions.

Catherine Clare Novack: Your next question comes from the line of Catherine Novack with Jones Research. Please go ahead.

Speaker Change: Your next question comes from the line of Catherine Novack with Jones Research. Please go ahead.

Catherine Clare Novack: Hey, good afternoon. Just another one on the phildenafil trial, the potential phase three trial. Can you remind us what you are still waiting on with regard to feedback? We know that you were aligned previously on indication and study population. So what endpoints are you proposing and then, the timing, is this a 12 week study or are you, would it potentially be longer or shorter? What's the duration?

Speaker Change: Hey, good afternoon.

Catherine Clare Novack: Just another one on the still does spill trial of a potential phase III trial.

Speaker Change: Can you remind us what you are still waiting on with regard to feedback. We know that you were allying previously on indication study population.

Catherine Clare Novack: What endpoints are you proposing and then.

Catherine Clare Novack: The timing is this a 12 week study or are you would it potentially.

Catherine Clare Novack: Actually be longer or shorter whats the duration.

Sabrina Martucci Johnson: Yeah, great questions and a great, great reminder to sort of refresh everyone on where we feel we already have great clarity from the FDA based on our December meeting. And we're really given that this is the 1st phase 3 study of its kind where, reasonably, the FDA needs a little more time to go through all of the information we provided. So, to your question.

Catherine Clare Novack: Yeah.

Catherine Clare Novack: Question then great.

Catherine Clare Novack: Great reminder, just sort of refresh everyone on where we feel we already have great clarity from the FDA based on our December meeting and were.

Speaker Change: Really given that this is the first phase III study of its kind where reasonably the FDA needed a little more time to go through all of the information we provided.

Sabrina Martucci Johnson: So, 1st of all, importantly, the patient population and the indication statement, and the duration of the efficacy period have all been agreed with the FDA. So, the indication statement is treatment of female sexual arousal disorder. So, very straightforward.

Speaker Change: To your question. So first of all importantly, the patient population and the indication statement and the duration of the efficacy period.

Speaker Change: Have all been agreed with the FDA. So the indication statement is treatment of female sexual arousal disorder to very straightforward to.

Sabrina Martucci Johnson: The patient population is women with female sexual arousal disorder, including women who may, as a result of their arousal disorder, have a decrease in desire. That's very common. It's not only common in female sexual arousal disorder. It's the same thing that happens in erectile dysfunction. So very common for an arousal dysfunction to lead to a decrease in desire. So that's the patient population

Speaker Change: The patient population are women with female sexual arousal disorder include.

Speaker Change: Including women, who may as a result of their arousal disorder have a decrease in desire.

Speaker Change: That's very common.

Speaker Change: It's not only coming in female sexual arousal disorder. It's the same thing that happens in erectile dysfunction.

Speaker Change: So very common for us.

Speaker Change: Ralph will just dysfunction to lead to a decrease in desire.

Speaker Change: So that's the patient population and then in terms of the duration of the efficacy assessment.

Sabrina Martucci Johnson: And then in terms of the duration of the efficacy assessment, the FDA guidance document for conditions of this nature, which actually includes a few different sexual dysfunctions, but arousal disorder is in there, suggests that 24-week studies may be necessary for Phase III, but based on our end-of-phase II meeting with the FDA and, frankly, just the number of sexual events that women had in our study and our ability to show how much data you can capture in So those are places where we've got good clarity, and that does, by the way, give us a lot in terms of that's part of why we're able to get so much prepared right now, because things like that, you know, for the duration that are needed, where we still have some outstanding questions in a couple areas.

Speaker Change: The FDA guidance document for conditions of this nature. It actually includes a few different sexual dysfunction, but arousal disorder is in there.

Speaker Change: Suggest that 24 week studies may be necessary for phase III.

Speaker Change: Based on our end of phase two meeting with the FDA and.

Speaker Change: Frankly, just the number of sexual events that we've had in our study and our ability to show how much data you can capture in a 12 week period in terms of experiences with the product.

Speaker Change: FDA was comfortable that you know an adequately powered 12 week efficacy study would be sufficient. So those are places where we've got good clarity and that does by the way gives us a lot in terms of if thats part of why we're able to get so much prepped right now because that tells you a lot in terms of funding right.

Speaker Change: Things like that.

Speaker Change: For the duration that are needed where we are we still have some outstanding questions or in a couple of areas.

Sabrina Martucci Johnson: One is just really understanding, you know, what ultimately may be necessary also to support safety and exposure data on the product. So, we included partners, for instance, in our phase to be study to see exposure to partners, right? We have the 12 week safety data from that.

Speaker Change: One is just really understanding.

Speaker Change: What ultimately may be necessary also to support.

Speaker Change: Safety and exposure data on the on the product. So we included partners for instance, in our phase <unk> study to see exposure to partners right. We have the 12 week safety data from that so we want to make sure. We are clearly aligned on any expectations in that regard.

Sabrina Martucci Johnson: So we want to make sure we're clearly aligned on any expectations in that regard. And then second, we want to make sure that you know we're clearly aligned on the endpoints. And so your question was around, so what have we suggested?

Speaker Change: And then second.

Speaker Change #102: We want to make sure that we are clearly aligned on the endpoint and so your question was around so what have we suggested so just as a reminder, the phase <unk> study.

Sabrina Martucci Johnson: So just as a reminder, in the Phase IIb study, the primary endpoint in the Phase IIb study was actually a co-primary endpoint; we had sections of a questionnaire called the sexual function questionnaire, and we asked specifically the arousal sensation questions from that questionnaire as part of our co-primary. It's four questions about genital sensations of arousal, so physical things that a woman is going to be feeling in her genital tissue. They're questions that are really highly linked to what happens when you get increased blood flow to the area, which is what sildenafil does.

Speaker Change:

Speaker Change: The primary endpoint in the phase <unk> was actually a co primary endpoint.

Speaker Change: We had.

Speaker Change #100: Sections of a questionnaire called the sexual function questionnaire, we asked specifically the arousal sensations questions from that questionnaire is part of our co primary it's four questions about genital sensations of arousal, so physical things that a woman is going to be feeling.

Speaker Change: In her genital tissue their questions that are really highly linked to what happens when you get increased blood flow to the area, which is what <unk> does.

Sabrina Martucci Johnson: We also asked a particular question about distress. The diagnostic criteria for erectile dysfunction and female sexual arousal disorder include the inability to attain or maintain the physical genital arousal response in men and women, respectively, of those indications, but in both cases, it also indicates that that dysfunction causes personal distress.

Speaker Change: But we also asked a particular question about distress. So the diagnostic criteria for erectile dysfunction and female sexual arousal disorder include that inability to obtain or maintain the physical genital arousal response and men or women respectively. Those indications.

Speaker Change: But also in both cases also indicates that that dysfunction causes personal distress. So in our phase <unk>. We had a question about distress. So part of what we've said and then we had a number of exploratory endpoints questions about desire or questions about orgasm.

Sabrina Martucci Johnson: In phase 2B, we had a question about distress. Then we had a number of exploratory endpoints, questions about desire, and questions about orgasm. And lots of other different particular questions about distress. We chose in the phase to be a particular question about concern, but that same questionnaire has questions about guilt and feeling inadequate, and being stressed about the condition. It has 15 total questions. So part of what we presented to phase, for phase three to the FDA, is a very robust analysis of the phase two B data that includes what's called psychometric analysis.

Speaker Change: And lots of other different particular questions about distress, we chose in the phase two be a particular question about concern, but that same questionnaire has questions about guilt and feeling inadequate and being stressed.

Speaker Change: About the condition is 15 total questions. So part of what we presented to the phase for the phase III to the FDA is a very robust analysis of the phase <unk> data that includes what's called the psychometric analysis. It's part of validating all of these different patient reported outcomes and we've made a recommendation of that.

Sabrina Martucci Johnson: It's part of validating all these different patient-reported outcomes. And we've made our recommendation of the hierarchy, right? For example, this is an arousal disorder. So obviously, the arousal sensations should continue to be a part of the primary. But other than that, what really belongs in the secondary?

Speaker Change #101: Hi, Archie right.

Speaker Change: This is arousal disorder. So obviously the arousal sensations should continue to be a part of the primary.

Speaker Change: But other than that what really belongs in the secondary.

Sabrina Martucci Johnson: And we saw improvements in orgasm. We saw improvements in desire. And we saw improvements on multiple questions from the Interpersonal Difficulty and Distress Scale.

Speaker Change: And we saw improvements in orgasm, we saw improvements in desire we saw improvements in multiple questions for.

Speaker Change: The interpersonal difficulty in distress scale.

Sabrina Martucci Johnson: So, you know, we'd like to have an opportunity to collect and include in our trial and include as potential to include in the label as many of these other aspects of the condition as possible. So that is what, you know, the FDA is reviewing right now. And for each of those, we've established through exit interviews from our phase two, what is a clinically meaningful improvement, it's not just enough to have a statistical improvement, but what matters, you know, to the woman. And so that's what the FDA is looking at right now, our proposal for, you know, arousal sensations clearly should be primary, but then what goes into secondary? And if there's a hierarchy, what's that hierarchy?

Speaker Change: So we'd like to have an opportunity to collect.

Speaker Change: And include in our trial and include as potential to include in the label as many of these.

Speaker Change: Other aspects of the condition as possible. So that is what the FDA is reviewing right now is.

Speaker Change: And for each of those we've established through exit interviews from our phase two what is a clinically meaningful improvement it's not just enough to have a statistical improvement, but what matters.

Speaker Change: To the woman and so that's what the FDA is looking at right now our proposal for arousal sensations clearly should be primary, but then what goes into secondary and if theres a hierarchy what's that hierarchy.

Sabrina Martucci Johnson: And our focus has been on all these different aspects of the sexual experience where we saw a clinically meaningful improvement; we're interested in including those in our phase three study if possible. So sorry for the long response, but hopefully that helps, you know, very clearly outline why we're excited about the data we generated in phase two but also why it takes a little time for the FDA to go through right through all of this. This is all brand new. We're the first sponsor that has ever done anything like this.

Speaker Change: And our focus has been on all of these different aspects of the sexual experience, where we saw a clinically meaningful improvement we're interested in including those in our phase III study of possible.

Speaker Change: So sorry for the long response, but hopefully that helps.

Speaker Change: Clearly outlined.

Speaker Change: Why were excited about the data we generated in phase two but also why it takes a little time for the FDA to go through right go through all of this this is all brand new where the first sponsor that ever did anything like this.

Catherine Clare Novack: Yeah, no, thanks. That's, that's helpful. Looking forward to FDA feedback, hopefully, later this quarter. And then just one more question on the Dare LARC.

Speaker Change: Yeah.

Speaker Change #103: That's helpful looking forward to FDA feedback hopefully later this quarter.

Speaker Change #104: And then just one more question on the Darling larch.

Speaker Change #104: Yes.

Speaker Change #105: So really interesting technology.

Catherine Clare Novack: You know, that's a really interesting technology. And I'm just curious, you know, what does the clinical program like that look for like that? You know, is it comparable to, let's say, what Implanon or Nexplanon looked at? Are you also trying to test the pause and resuming dosing? Yeah.

Speaker Change #105: And I'm just curious.

Speaker Change #105: What is the clinical program like that look more like that.

Speaker Change #103: Comparable to let's say what.

Speaker Change #103: And pulled out and put on a next one on looked at or are you also trying to test the.

Speaker Change #106: The pause.

Speaker Change #103: And.

Speaker Change #103: Assuming dosing.

Sabrina Martucci Johnson: Yeah, that's a great question. So we've started to obviously do work on what the ultimate clinical program looks like and and started to You know map out kind of that engagement with the FDA around that But to the first part of your question the contraceptive effectiveness part is yes It's it's going to look very much like what an explanon right any sort of implant hormone releasing implant product looks like where you're able to establish through phase one what your relevant doses of those hormones are and then typically move straight into a contraceptive effectiveness study because you have demonstrated that you have the hormones at the right level and then you Continue to you know, you you do have to study so similar to like what those products do is you tend to like get your Approval in increments, right?

Speaker Change #107: Yeah. That's a great question. So we have started to obviously to work on what the ultimate clinical program.

Speaker Change #103: Looks like and started too.

Speaker Change #103: Map out kind of that engagement with the FTAA around that.

Speaker Change #103: But to the first part of your question. The contraceptive effectiveness part is yes, it's going to look very much like what an excellent on rate any sort of implant hormone releasing implant product.

Speaker Change #103: It looks like where you are able to establish through phase one what you're relevant doses of those hormones are and then typically move straight into a contraceptive effectiveness study because you've demonstrated that you have the hormones at the right level and then you continue to.

Speaker Change #113: You do have to study so similar to like what those products do is you tend to like get your approval in increments rights you might first go after a one year two year three year rate duration, and then you keep following the women to keep extending your years.

Sabrina Martucci Johnson: So you might first go after a one-year, two-year, three-year duration, right? And then you keep following the women to keep extending your years of effectiveness, so very analogous to what you know the hormone-releasing products have done and like the next one on as well going for their five-year. So So that's, you know, so from that piece, the piece that And then, non-clinically, we've already demonstrated like the pause open, you know, open on demand. But that will definitely be part of the conversation with the FDA in terms of what demonstration of that in vivo, right? It will be sufficient to show that in phase 1. Right, or would that need to be part of any phase three regimen as well?

Speaker Change #103: Of effectiveness, so very analogous to what the hormone releasing products have done and Mike next one on as well gone for their five year. So.

Speaker Change #103: So that's so.

Speaker Change #103: From that piece the piece that.

Speaker Change #103: And then non clinically we have already demonstrated like the pause open open on demand.

Speaker Change #103: The component of the pause resume but that will be a piece that will definitely be part of the conversation with the FDA in terms of what.

Speaker Change #103: Demonstration of that in vivo right.

Speaker Change #103: Will be sufficient to show that in phase one.

Speaker Change #111: Right or would that be need to be part of any phase III regimen as well.

Catherine Clare Novack: Got it. Okay. Thanks for taking my questions.

Speaker Change #108: Got it.

Speaker Change #111: Okay. Thanks for taking my questions.

Sabrina Martucci Johnson: Great, thank you.

Speaker Change #109: Great. Thank you.

Operator: That concludes the Q&A session. I would like to turn the call back over to Sabrina Martucci-Johnson for any additional or closing remarks.

Speaker Change #116: That concludes the question and answer session I would like to turn the call back over to Sabrina Martucci Johnson for any additional or closing remarks.

Sabrina Martucci Johnson: Thank you. Well, I really appreciated the great questions, and I do have some closing comments.

Speaker Change #114: Thank you well I really appreciate the great questions and I do have some closing comments first of all to thank everyone for taking the time.

Sabrina Martucci Johnson: First of all, to thank everyone for taking the time to hear about the recent updates and our ongoing commitment to drive value for all of our DARI stakeholders by identifying and advancing potential new therapies to provide additional choices, enhance outcomes, and ease of use for women. And, you know, building on the momentum of 2023, there's no doubt that it's an incredible time to be working in women's health, quite frankly. We continue to be excited about the increased attention to this space through the various White House initiatives and our active participation in them, including the ARPA-H ideation event that we attended in February of this year, and the executive order signing at the White House in March.

Speaker Change #109: To hear about the recent updates in our ongoing commitment to drive value for all of our stakeholders by identifying and advancing potential new therapies to provide additional choices enhance outcomes and ease of use for women.

Speaker Change #109: And building on the momentum of 2023, there is no doubt that it's an incredible time to be working in women's health quite frankly, we continue to be excited about the increased attention on the space through the various white house initiatives and our active participation in them.

Speaker Change #110: <unk> the ARPA HIV aviation event that we attended in February of this year, the executive order signing at the White House in March and Additionally, we're thrilled to see the recent unveiling of a bipartisan Senate Bill that would authorize $275 million to boost research training in public awareness around men.

Sabrina Martucci Johnson: And additionally, we're thrilled to see the recent unveiling of a bipartisan Senate bill that would authorize $275 million to boost research, training, and public awareness around menopause specifically and midlife women's health issues, an area that is often stigmatized and overlooked and underfunded, and that is particularly relevant to us, given that our work on DARE HRT1, which while it was not the focus of today's call, is a program that we It's a potential first vaginal monthly therapy for the vasomotor symptoms of menopause, as well as our Phase 2 Ready Dare VVA1, our hormone-free vaginal candidate for sexual pain related to menopause.

Speaker Change #110: <unk>, specifically in midlife women's health issues and.

Speaker Change #110: An area that is often stigmatized and overlooked and underfunded and that is particularly relevant to us given that our work on <unk>, one which while it was not the focus of today's call is a program that we are also preparing for phase III, it's a potential first vaginal monthly therapy.

Speaker Change #110: <unk> for the visa motor symptoms of menopause.

Speaker Change #110: As well as our phase III ready <unk> BVA, one R hormone free vaginal candidate for sexual pain related to menopause. So we're looking forward to seeing continued progress in the enterprise space and the potential progress of this new bill.

Sabrina Martucci Johnson: So we're looking forward to seeing continued progress in the menopause space and the potential progress of this new bill. Earlier this month, we were also selected as a member or spokesperson of the Investor Catalyst Hub, which is the regional hub of ARPA-NetH, the nationwide health innovation network launched by ARPA-H. Through our participation, we get access to potential funding and flexible contracting for faster award execution compared to traditional government contracts

Speaker Change #110: Earlier. This month, we were also selected as a member spoke of the Investor catalyst hub, which is the regional hub ARPA net H the nationwide health innovation network launched by ARPA H.

Speaker Change #110: Through our participation, we get access to potential funding and flexible contracting for faster award execution compared to traditional government contracts.

Sabrina Martucci Johnson: We can provide input on ARPA-H challenge areas and priorities and really help to ensure that women's health remains at the forefront of innovation. So these moments truly show just how much can be accomplished by bringing focus and investment to the entire ecosystem so that we can boldly innovate for women. And as you heard today, we're making great progress, and we're excited about what the rest of this year holds for DARE. As we look ahead to the rest of the year, we expect several milestones this year, including, as we've been talking about, OverPREEN and the Pivotal Study update.

Speaker Change #110: We can provide input on ARPA H challenge areas and priorities and really help to ensure that women's health remains at the forefront of innovation. So these moments truly showed just how much can be accomplished by bringing focus and investment to the entire ecosystem. So that we can boldly innovate for women.

Speaker Change #110: And as you heard today were making great progress and we're excited for what the rest of this year holds for DRA as we look ahead to the rest of the year, we expect several milestones.

Speaker Change #110: This year, including as we've been talking about over Crane and the pivotal study updates.

Sabrina Martucci Johnson: As we're working to complete what we expect to be the single registration study and are definitely looking forward to giving updates on our discussions with the FDA and the activities to commence our Phase III for our potential first-in-category treatment option for female sexual arousal disorders, Sidenafil cream. With our unique model and the support of our commercial collaborators through all of that, we believe we're well positioned to accelerate innovation for women, while also driving value for all of our DARE stakeholders. And we look forward to keeping you updated on our progress toward the milestones we discussed today. So, thank you.

Speaker Change #115: As we're working to complete where we expect to be the single registration study and are definitely looking forward to giving updates on our discussions with the FDA and the activities to commence our phase III for our potential first in category treatment option for female sexual arousal disorder should NFL cream, so our unique model and.

Speaker Change #115: The support of our commercial collaborators through all of that we believe we're well positioned.

Speaker Change #115: To accelerate innovation for women, while also driving value for all of our dairy stakeholders and we look forward to keeping you updated on our progress towards the milestones we discussed today. So thank you.

Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining us. You may now disconnect.

Speaker Change #117: And gentlemen that concludes today's call. Thank you all for joining you may now disconnect.

Speaker Change #115: Okay.

Speaker Change #115: [music].

Speaker Change #115: Yeah.

Speaker Change #115: [music].

Speaker Change #115: Okay.

Speaker Change #115: [music].