Q2 2024 Dare Bioscience Inc Earnings Call

Leonardo: Welcome to the conference call hosted by Dare Bioscience to review the company's second quarter financial results and to provide a general business update. This call has been recorded. With us today from Dare are Sabrina Martusi Johnson, President and Chief Executive Officer, and MarDee Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton, please proceed.

Operator: Welcome to the conference call hosted by Dare Bioscience to review the company's second quarter financial results and to provide a general business update. This call has been recorded.

Speaker Change: Welcome to the conference call hosted by Daray Bioscience to review the company's second quarter financial results and to provide a general business update.

Unknown Executive: This call has been recorded. My name is Leonardo and I will be your refrigerator today.

Leonardo: My name is Leonardo, and I will be your operator today. With us today from Dare are Sabrina Martusi Johnson, President and Chief Executive Officer, and MarDee Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton, please proceed. Good afternoon, and welcome to the Dare Bioscience Financial Results and Business Update call for the quarter ended June 30, 2024. Today, we will review our second-quarter results and discuss developments and expectations for our pipeline and portfolio. I'd 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.

Leonardo: This call has been recorded. My name is Leonardo and I will be your operator today.

Unknown Executive: With us today, from Dare, are Sabrina Martici, Johnson, President and Ship Executive Officer, and MarDee Haring Layton, Ship Accounting Officer. Miss Haring Layton, please proceed.

Speaker Change: With us today from Daray are Sabrina Martusi.

Leonardo: Johnson, President and Chief Executive Officer, and Mardee Haring-Lehton, Chief Accounting Officer. Ms. Haring-Lehton, please proceed.

MarDee Haring Layton: Good afternoon and welcome to the Dare Bioscience financial results and business update call for the quarter ended June 30th, 2024. Today we will review our second quarter results and discuss developments and expectations for our pipeline and portfolio.

MarDee Haring: Good afternoon, and welcome to the Dare Bioscience Financial Results and Business Update call for the quarter ended June 30, 2024. Today, we will review our second quarter results and discuss developments and expectations for our pipeline and portfolio. I'd 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.

Mardee Haring-Lehton: Good afternoon and welcome to the Dari Bioscience Financial Results and Business Update call for the quarter ended June 30, 2024.

Mardee Haring-Lehton: Today, we will review our second quarter results and discuss developments and expectations for our pipeline and portfolio.

Leonardo: Any statements made during this call that are not statements of historical facts 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.

MarDee Haring: Any statements made during this call that are not statements of historical facts 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. 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's SEC filings, including on Form 10-Q for the quarter ended June 30, 2024, which was filed today.

MarDee Haring Layton: I'd like to remind you that today's discussion will include forward-looking statements within the meeting of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements.

Speaker Change: I'd 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.

Speaker Change: Any statements made during this call that are not statements of historical fact 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.

MarDee Haring-Layton: 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 on Form 10-Q for the quarter ended June 30, 2024, which was filed today. I would also like to point out that the content of this call includes time-sensitive information that is current as of today, August 12, 2024. The RA undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. I will now turn it over to Sabrina.

MarDee Haring Layton: Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including on Form 10-Q for the quarter ended June 30th, 2024, which was filed today.

Speaker Change: You should not place undue reliance on forward-looking statements.

Speaker Change: Board looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including on Form 10-Q for the quarter ended June 30, 2024, which was filed today.

MarDee Haring Layton: I would also like to point out that the content of this call includes time-sensitive information that is current as of today, August 12th, 2024. Sorry, undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

MarDee Haring: I would also like to point out that the content of this call includes time-sensitive information that is current as of today, August 12, 2024. DARE undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. I will now turn it over to Sabrina.

Sara: I would also like to point out that the content of this call includes time-sensitive information that is current as of today, August 12, 2024. SARA undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

MarDee Haring Layton: I will now turn it over to Sabrina. Thank you.

Sara: I will now turn it over to Sabrina.

Sabrina Johnson: I always like to start our quarterly calls by taking a minute to remind those of you who may be newer to the Dari story of our purpose and our mission. We believe Dari 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 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.

Sabrina Johnson: I always like to start our quarterly calls by taking a minute to remind those of you who may be newer to the Dari story of our purpose and our 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.

Sabrina Martusi Johnson: Thank you. I always like to start our quarterly calls by taking a minute to remind those of you who may be newer to the Dari story of our purpose and our 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.

Sabrina: Thank you.

Sabrina: I always like to start our quarterly calls by taking a minute to remind those of you who may be newer to the Dari story of our purpose and our mission.

Speaker Change: We believe Daray is the only publicly traded company focused solely on women's health, pharmaceutical product development broadly.

Speaker Change: 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.

Speaker Change: 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.

Sabrina 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 previously been applied to the indication in question for women. We believe we have the broadest portfolio of potential high-impact first-in-category product candidates to improve the health and well-being of women, many of which have already demonstrated proof of concept, and that our robust pipeline positions us for the short, medium, and long-term.

Sabrina 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 previously been applied to the indication in question for women. We believe we have the broadest portfolio of potential high-impact, first-in-category product candidates to improve the health and well-being of women, many of which have already demonstrated proof of concept, and that our robust pipeline positions us well for the short, medium, and long-term.

Sabrina Martusi 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 previously been applied to the indication in question for women. We believe we have the broadest portfolio of potential high-impact, first-in-category product candidates to improve the health and well-being of women, many of which have already demonstrated proof-of-concept, and that our robust pipeline positions us well for the short, medium, and long-term.

Speaker Change: by boldly addressing existing therapeutic gaps.

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 previously been applied to the indication in question for women.

Speaker Change: We believe we have the broadest portfolio of potential high-impact.

Speaker Change: First in category, Product Candidates.

Speaker Change: to improve the health and well-being of women, many of which have already demonstrated proof of concept and that our robust pipeline positions us well for the short, medium and long-term.

Sabrina Johnson: During our last update call, we discussed the strides we made last year to advance innovative therapies for women and the key milestone anticipated for 2020. in 2004. In addition to the continued commercialization of Zashiyato, Clinton, Mayas, and Foss State, Vaginal Gel, 2%, the first FDA-approved product to emerge from our portfolio and a treatment for bacterial vaginosis in females aged 12 and older that became available nationwide by prescription earlier this year via our collaborator, Organon. We also discussed anticipated milestones, focused on our first and category product candidates related to continuing to progress toward a phase 3 trial of Savannah Phil Cream, 3.6%, which has the potential to be the first FDA-approved treatment for female sexual arousal disorder, for which there are now FDA-approved treatments, and continuing to enroll in our phase 3 study of OvaPreen, our potentially first and category hormone-free monthly vaginal contraceptive candidate.

Sabrina Johnson: During our last update call, we discussed the strides we made last year to advance innovative therapies for women and the key milestones anticipated for 2024. In addition to the continued commercialization 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 aged 12 and older that became available nationwide by prescription earlier this year via our collaborator Organon. We also discussed anticipated milestones focused on our first-in-category product candidates related to continuing to progress toward a Phase III trial of sidenafil cream, 3.6%, which has the potential to be the first FDA-approved treatment for female sexual arousal disorder, for which there are no FDA-approved treatments, and continuing to enroll in our Phase III study of oviprene are potentially first-in-category hormone-free monthly intravaginal contraceptive candidates.

Sabrina Martusi Johnson: During our last update call, we discussed the strides we made last year to advance innovative therapies for women and the key milestones anticipated for 2021. In addition to the continued commercialization 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 aged 12 and older that became available nationwide by prescription earlier this year, via our collaborator.

Speaker Change: During our last 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: In addition to the continued commercialization of Zasciato Clindamycin Phosphate Vaginal Gel 2%,

Speaker Change: The first FDA-approved product to emerge from our portfolio and a treatment for bacterial vaginosis in females aged 12 and older that became available nationwide by prescription earlier this year via our collaborator Organon.

Sabrina Martusi Johnson: We also discussed anticipated milestones focused on our first-in-category product candidates related to continuing to progress toward a Phase III trial of sidenafil cream, 3.6%, which has the potential to be the first FDA-approved treatment for female sexual arousal disorder, for which there are no FDA-approved treatments, and continuing to enroll in our Phase 3 study of oviprene, a potentially first-in-category hormone-free monthly We'll also highlight today the status of, and what comes next for, our two product candidates in the menopause space, our monthly vaginal hormone therapy for hot flashes, and our hormone-free vaginal insert for sexual pleasure. Before I do, I'm going to first turn the call back over to our Chief Accounting Officer, MarDee, to review our second quarter financial results. Thanks, Sabrina, and thanks everyone for joining us today.

Speaker Change: We also discussed anticipated milestones.

Speaker Change: Focused on our first in category product candidates related to Continuing to progress toward a phase 3 trial of sidenafil cream 3.6 percent

Speaker Change: which has the potential to be the first FDA approved treatment for female sexual arousal disorder.

Speaker Change: For which there are no FDA approved treatments and continuing to enroll in our phase 3 study of oviprene are potentially first in category hormone free monthly intravaginal contraceptive candidates.

Sabrina Johnson: Today, we'll review our progress against the anticipated milestones for OvaPreen and Savannah Phil Cream, with the focus on providing context and metrics that are important for understanding the potential impact of these programs. We'll also highlight today the status of and what comes next for our two product candidates in the menopause space, our monthly vaginal hormone therapy for hot flashes and our hormone-free vaginal infant for sexual pain.

Sabrina Johnson: Today, we'll review our progress against the anticipated milestones for OverCream and Sobenafil Cream with a focus on providing context and metrics that are important to understanding the potential impact of these programs. We'll also highlight today the status of, and what comes next for, our two product candidates in the menopause space, our monthly vaginal hormone therapy for hot flashes, and our hormone-free vaginal insert for sexual pleasure. Before I do, I'm going to first turn the call back over to our Chief Accounting Officer, MarDee, to review our second quarter financial results.

Speaker Change: Today, we'll review our progress against the anticipated milestones for Overcream and Sobenafil Cream with a focus on providing context and metrics that are important to understanding the potential impact of these programs.

Speaker Change: We'll also highlight today the status of, and what comes next for, our two product candidates in the menopause space, our monthly vaginal hormone therapy for hot flashes, and our hormone-free vaginal insert for sexual pain.

MarDee Haring Layton: Before I do, I'm going to first turn the call back over to our Chief Accounting Officer, Marty, to review our second quarter financial results. Thanks, Sabrina, and thanks everyone for joining us today. I would now like to summarize Dari's financial results for the quarter ended June 30, 2024, which I will refer to as the second quarter. As Sabrina mentioned, Dari's business strategy is to assemble an advanced support folio 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.

Speaker Change: Before I do, I'm going to first turn the call back over to our Chief Accounting Officer, Mardee, to review our second quarter financial results.

MarDee Haring: Thanks, Sabrina. And thanks, everyone, for joining us today. I would now like to summarize Dare's financial results for the quarter ended June 30, 2024, which I will refer to as the second 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.

MarDee Haring-Layton: I would now like to summarize Dare's financial results for the quarter ended June 30, 2024, which I will refer to as the second 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.

Mardee Haring-Lehton: Thanks, Sabrina. And thanks, everyone, for joining us today. I would now like to summarize DARE's financial results for the quarter ended June 30, 2024, which I will refer to as the second quarter.

MarDee Haring: During the second quarter of 2024, our general and administrative expenses, or G&A, were approximately $2.4 million, which was a 16% decrease compared to Q2 2023, due primarily to reduced headcount and reduced professional services expense. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory, and other activities across our entire portfolio, were approximately $4.9 million for the second quarter, which is a 19% decrease compared to Q2 2023.

MarDee Haring-Layton: During the second quarter of 2024, our general and administrative expenses, or G&A, were approximately $2.4 million, which was a 16% decrease compared to Q2 2023, due primarily to reduced headcount and reduced professional services expense. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory, and other activities across our entire portfolio, were approximately $4.9 million for the second quarter, which is a 19% decrease compared to Q2 2023.

Mardee Haring-Lehton: As Sabrina mentioned, DAHRE'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.

MarDee Haring Layton: The investment required to build an advanced support folio includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development, or R&D expenses. During the second quarter of 2024, our general administrative expenses, or GNA, were approximately 2.4 million, which is a 16 percent decrease compared to Q2 2023, due primarily to reduce head count and reduce professional services expense. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory, and other activities across our entire portfolio, were approximately 4.9 million for the second quarter, which is a 19 percent decrease compared to Q2 2023.

Mardee Haring-Lehton: 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.

Speaker Change: During the second quarter of 2024, our general and administrative expenses, or G&A, were approximately $2.4 million, which is a 16% decrease compared to Q2 2023, due primarily to reduced headcount and reduced professional services expense.

Speaker Change: Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory, and other activities across our entire portfolio, were approximately $4.9 million for the second quarter, which is a 19% decrease compared to Q2 2023.

MarDee Haring Layton: As we guided previously this year, we continue to anticipate our full-year 2024 R&D expenses will be less than our 2023 R&D expenses. Our comprehensive income for the second quarter was approximately 12.9 million, driven by proceeds from the royalty monetization transaction we closed in April. We ended the second quarter with approximately 16.4 million in cash and cash equivalent, and had approximately 8.5 million shares of common stock outstanding as of August 9, which reflects the reverse stock split that was implemented on July 1, 2024. In April, we announced and closed a royalty monetization transaction with Zelma, in which DRA received 22 million in gross proceeds, and following a pre-specified total return to Zelma, Zelma will make upside-sharing milestone payments to DRA equal to 50 percent of all remaining cash flows sold to Zelma under the transaction.

MarDee Haring-Layton: As we guided previously this year, we continue to anticipate our full-year 2024 R&D expenses will be less than our 2023 R&D expenses. Our comprehensive income for the second quarter was approximately $12.9 million, driven by proceeds from the royalty monetization transaction we closed in April. We ended the second quarter with approximately $16.4 million in cash and cash equivalents and had approximately 8.5 million shares of common stock outstanding as of August 9th, which reflects the reverse stock split that was implemented on July 1st, 2024.

MarDee Haring: As we guided previously this year, we continue to anticipate our full-year 2024 R&D expenses will be less than our 2023 R&D expenses. Our comprehensive income for the second quarter was approximately $12.9 million, driven by proceeds from the royalty monetization transaction we closed in April. We ended the second quarter with approximately $16.4 million in cash and cash equivalents and had approximately 8.5 million shares of common stock outstanding as of August 9th, which reflects the reverse stock split that was implemented on July 1st, 2024.

Speaker Change: As we guided previously this year, we continue to anticipate our full year 2024 R&D expenses will be less than our 2023 R&D expenses.

Speaker Change: Our comprehensive income for the second quarter was approximately $12.9 million.

Speaker Change: driven by proceeds from the royalty monetization transaction we closed in April.

Speaker Change: We ended the second quarter with approximately $16.4 million in cash and cash equivalents and had approximately 8.5 million shares of common stock outstanding as of August 9, which reflects the reverse stock split that was implemented on July 1, 2024.

MarDee Haring-Layton: In April, we announced and closed 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. 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.

MarDee Haring: In April, we announced and closed 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. 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.

Speaker Change: In April, we announced and closed a royalty monetization transaction with Zoma in which Daray received $22 million in gross proceeds, and following a pre-specified total return to Zoma, Zoma will make upside sharing milestone payments to Daray equal to 50% of all remaining cash flows sold to Zoma under the transaction.

MarDee Haring Layton: This monetization of future net royalty and net milestone payments accelerates potential cash flows from the future commercial success of Zalciato, and ensures that DRA and our shareholders have the opportunity to participate meaningfully in Zalciato economics as commercialization progresses. This non-deludive financing provides DRA with a significant capital to help achieve our objectives and, importantly, allows us to focus on advancing our late-stage potential first-ing category, investigational products, over-cream, and salventful creams, both of which represent large-market opportunities. The structure of this transaction also underscores the significant potential of over-cream and salventful creams, with DRA retaining the significant majority of future economics and the ability to achieve attractive margins through retained net sales in all commercial milestones.

Speaker Change: This monetization of future net royalty and net milestone payments accelerates potential cash flows from the future commercial success of Zocciato and ensures that Daray and our shareholders have the opportunity to participate meaningfully in Zocciato economics as commercialization progresses.

MarDee Haring: This non-dilutive financing provides Dare with significant capital to help achieve its objectives and importantly allows us to focus on advancing our late-stage potential first-in-category investigational products, Ova-Cream and Sildenafil Cream, both of which represent large market opportunities. The structure of this transaction also underscores the significant potential of ovocrine and fuldenafilcrine with Dare retaining a significant majority of future economics and the ability to achieve attractive margins through retained net sales at all commercial milestones.

MarDee Haring-Layton: This non-dilutive financing provides Dare with significant capital to help achieve its objectives and, importantly, allows us to focus on advancing our late-stage potential first-in-category investigational products, Ova-Cream and Sildenafil Cream, both of which represent large market opportunities. The structure of this transaction also underscores the significant potential of ovocrine and fuldenofocrine with Dare retaining a significant majority of future economics and the ability to achieve attractive margins through retained net sales at all commercial milestones.

Speaker Change: This non-dilutive financing provides DARA with significant capital to help achieve our objectives and, importantly, allows us to focus on advancing our late-stage potential first-in-category investigational products, Ovacreen and Sildenafil cream, both of which represent large market opportunities.

Speaker Change: The structure of this transaction also underscores the significant potential of Ovacreen and Fildenafil cream, with DARA retaining the significant majority of future economics and the ability to achieve attractive margins through retained net sales in all commercial milestones.

MarDee Haring Layton: In the second quarter, we also received 1 million as the latest installment under our grant agreement with Foundation in support of our investigational contraceptive, Dare Lark 1. Under the terms of the grant agreement, DRA may receive a total of up to approximately 49 million to support non-clinical development of Dare Lark 1. This funding will allow us to advance the development of Dare Lark 1 through non-clinical proof of principal 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.

MarDee Haring-Layton: In the second quarter, we also received $1 million in the latest installment under our grant agreement with the Foundation in support of our investigational contraceptive, Dar-Lark-1. Under the terms of the grant agreement, DARA may receive a total of up to approximately $49 million to support the non-clinical development of Dar-Lark-1. This funding will allow us to advance the development of Dar-Lark-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, DARE has received approximately $29.3 million under the DARE LARC I grant agreement.

MarDee Haring: In the second quarter, we also received $1 million in the latest installment under our grant agreement with the Foundation in support of our investigational contraceptive, Dar-Lark-1. Under the terms of the grant agreement, DARA may receive a total of up to approximately $49 million to support the non-clinical development of Dar-Lark-1. This funding will allow us to advance the development of Dar-Lark-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.

Speaker Change: In the second quarter, we also received $1 million at the latest installment under our grant agreement with the foundation in support of our investigational contraceptive, DERLARC-1.

Speaker Change: Under the terms of the grant agreement, DARA may receive a total of up to approximately $49 million to support non-clinical development of DARELRK1.

Speaker Change: This funding will allow us to advance the development of DERLARC1 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.

MarDee Haring Layton: To date, DRA has received approximately 29.3 million under the Dare Lark 1 grant agreement. Together, the royalty financing and latest installment in grant funding represent our commitment to being creative, collaborative, and opportunistic, and seeking capital needed to meet our objectives and to build shareholder value.

MarDee Haring: To date, DARE has received approximately $29.3 million under the GARELARC-1 grant agreement. Together, the royalty financing and the latest installment in grant funding represent our commitment to being creative, collaborative, and opportunistic and seeking the capital needed to meet our objectives and to build shareholder value. We encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, and risk factors in our Form 10-Q for the quarter ended June 30th, 2024, which we filed this afternoon, as well as our annual Form 10-K for the year ended December 31st, 2023, which was filed on March 28th, 2024. I'd now like to return the call to Sabrina.

Speaker Change: To date, DARE has received approximately $29.3 million under the DARE LARC I grant agreement.

Sabrina Johnson: Great. Thank you, MarDee.

MarDee Haring-Layton: 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. We encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, and risk factors in our Form 10-Q for the quarter ended June 30, 2024, which we filed this afternoon, as well as our annual Form 10-K for the year ended December 31, 2023, which was filed on March 28, 2024. I'd now like to return the call to Sabrina.

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

MarDee Haring Layton: We encourage investors to review the more detailed discussion of our financial, financial condition, liquidity, capital resources, and risk factors in our Form 10-Q for the quarter ended June 30, 2024, which we filed this afternoon, as well as our annual Form 10-K for the year ended December 31, 2023, which was filed on March 28, 2024.

Speaker Change: We encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, and risk factors in our Form 10-Q for the quarter ended June 30, 2024, which we filed this afternoon, as well as our annual Form 10-K for the year ended December 31, 2023, which was filed on March 28, 2024.

Sabrina Johnson: I'd now like to return the call back over to Sabrina. Great, thank you, Marty. I'm now going to talk through our 2024 accomplishments to date and to participate in milestones with the focus on our late-stage candidates to the NFL Cream and Ova Cream. But first, I'll provide an update on our on-market asset, Zasciato. So, as a reminder, Zasciato, or clindamycin phosphate 2% vaginal gel, is indicated for the treatment of bacterial vaginosis in 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, notice time spent in place.

Sabrina Martusi Johnson: Great, thank you, MarDee. I'm now going to talk through our 2024 accomplishments to date and some anticipated milestones, with a focus on our late stage candidates for Benefil CREAM and OVIPR. But first, I'll provide an update on our on-market asset, Zosciato. As a reminder, Zosciato, or clindamycin phosphate 2% vaginal gel, is indicated for the treatment of bacterial vaginosis in females 12 years of age and older.

Sabrina Johnson: I'm now going to talk through our 2024 accomplishments to date and some anticipated milestones, with a focus on our late-stage candidates for Benefilcreme and Ovaprene. But first, I'll provide an update on our on-market asset, Zosciato. So, as a reminder, Zosciato, or clindamycin phosphate 2% vaginal gel, is indicated for the treatment of bacterial vaginosis in 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.

Speaker Change: I'd now like to return the call back over to Sabrina.

Sabrina: Great. Thank you, Mardee.

Sabrina: I'm now going to talk through our 2024 accomplishments to date and some anticipated milestones with the focus on our late-stage candidates to Benefield Cream and Obiprene.

Sabrina: But first, I'll provide an update on our on-market asset, Zashiato.

Sabrina: So, as a reminder, Zasciato, or clindamycin phosphate 2% vaginal gel, is indicated for the treatment of bacterial vaginosis in females 12 years of age and older.

Sabrina Martusi Johnson: 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 the first quarter of 2024, through our commercialization agreement with Organon, Dashiato will become available by prescription across the United States. The Organon Women's Health Sales Team continues to see steady month-over-month increases in total prescriptions of Zosciato and new prescriber volumes in line with the opportunity for a new branded entrant in the category.

Sabrina: 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 Johnson: In the first quarter of 2024, through our commercialization agreement with Oregonon, Zasciato became available by prescription across the United States. The Organ on Women's Health Sales team continues to see steady month-over-month increases in total prescriptions of Zasciato and new prescriber volumes in line with the opportunity for a new branded entrance in the category. There are positive signals related to strong clinical acceptance among early adopters with multiple uses among trialists paired with a positive patient reception, and the team continues to unlock access channels for a frictionist fulfillment experience for both patients and providers.

Sabrina Johnson: In the first quarter of 2024, through our commercialization agreement with Organon, Zasciato became available by prescription across the United States. The Organon Women's Health Sales Team continues to see steady month-over-month increases in total prescriptions of Zosciato and new prescriber volumes in line with the opportunity for a new branded entrant in the category. There are positive signals related to strong clinical acceptance among early adopters with multiple uses among trialists paired with positive patient reception, and the team continues to unlock access channels for a frictionless fulfillment experience for both patients and providers.

Sabrina: In the first quarter of 2024, through our commercialization agreement with Organon, Zosciato became available by prescription across the United States.

Speaker Change: The Organon Women's Health Sales Team continues to see steady month-over-month increases in total prescriptions of Zocciato and new prescriber volumes in line with the opportunity for a new branded entrant in the category.

Sabrina Martusi Johnson: There are positive signals related to strong clinical acceptance among early adopters with multiple uses among trialists paired with positive patient reception, and the team continues to unlock access channels for a frictionless fulfillment experience for both patients and providers.

Speaker Change: There are positive signals related to strong clinical acceptance among early adopters with multiple uses among trialists paired with a positive patient reception.

Speaker Change: And the team continues to unlock access channels for a frictionless fulfillment experience for both patients and providers.

Sabrina Johnson: I now like to provide an update on Sydenicel cream, 3.6 percent. So during the second quarter, we continued our interactions with the FDA on the development program for Sydenicel Cream as a treatment for female sexual arousal disorder, including with respect to the proposed efficacy endpoints to take forward into phase three development. The patient population and the endpoints we proposed to the FDA for phase three clinical development were those where our post-talk analyses for the phase two these study data showed that Sydenicel Cream demonstrated statistically significant and meaningful patient improvements. During the second quarter, we provided responsive materials to queries from the FDA regarding patient-reported outcomes and the qualitative assessment of within-patient clinically meaningful improvement that we saw in the phase two these study based on the participant exit interviews.

Sabrina Johnson: I'd now like to provide an update on Cidenafil Cream 3.6%. During the second quarter, we continued our interactions with the FDA on the development program for Civenafil cream as a treatment for female sexual arousal disorder, including with respect to the proposed efficacy endpoints to take forward into phase three development. The patient population and the endpoints we proposed to the FDA for Phase III clinical development were those where our post-hoc analyses of the Phase IIb study data showed that sidenafil cream demonstrated statistically significant and meaningful patient improvement.

Sabrina Martusi Johnson: I'd now like to provide an update on Civenafil Cream 3.6%. During the second quarter, we continued our interactions with the FDA on the development program for subenafilcrine as a treatment for female sexual arousal disorder, including with respect to the proposed efficacy endpoints to take forward into phase three development. The patient population and the endpoints we proposed to the FDA for Phase III clinical development were those where our post-hoc analyses of the Phase IIb study data showed that sidenafil cream demonstrated statistically significant and meaningful patient improvement.

Speaker Change: I'd now like to provide an update on Civenafil Cream 3.6%.

Speaker Change: So, during the second quarter, we continued our interactions with the FDA on the development program for Sidenafil cream as a treatment for female sexual arousal disorder, including with respect to the proposed efficacy endpoints to take forward into phase three development.

Speaker Change: The patient population and the endpoints we proposed to the FDA for Phase III clinical development were those where our post-hoc analyses for the Phase IIb study data showed that sidenafil cream demonstrated statistically significant and meaningful patient improvements.

Sabrina Martusi Johnson: During the second quarter, we provided responsive materials to queries from the FDA regarding patient-reported outcomes and the qualitative assessments of within-patient clinically meaningful improvements that we saw in the Phase IIb study based on participant exit and return. While the FDA indicated it anticipated providing additional feedback during the 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, its review is ongoing, and we look forward to providing updates on the FDA's feedback, the Phase III study design and plans, as well as any relevant updates on our collaboration strategy as they become available.

Sabrina Johnson: During the second quarter, we provided responsive materials to queries from the FDA regarding patient-reported outcomes and qualitative assessments of within-patient clinically meaningful improvements that we saw in the Phase IIb study based on the participant exit intervention. While the FDA indicated it anticipated providing additional feedback during the second quarter on the Phase 3 design, which would be the first ever Phase 3 pivotal study of a therapeutic candidate for the treatment of arousal disorder in women, its review is ongoing, and we look forward to providing updates on the FDA's feedback, the Phase 3 study design and plans, as well as any relevant updates on our collaboration strategy as they become available. In preparation for the initiation of Phase 3, during the second quarter, we completed the bid defense meetings with the CROs being considered for the Phase 3 studies and launched the manufacturing campaign to support Phase 3.

Speaker Change: During the second quarter, we provided responsive materials to queries from the FDA regarding patient-reported outcomes and the qualitative assessments of within-patient clinically meaningful improvements that we saw in the Phase IIb study based on the participant exit interviews.

Sabrina Johnson: While the FDA had indicated it anticipated providing additional feedback during the second quarter on the phase three design, which would be the first ever phase three pivotal study of a therapeutic candidate for the treatment of arousal disorder in women. Its review is ongoing, and we've looked forward to providing updates on the FDA's feedback, the phase three study design and plans, as well as any relevant updates on our collaboration strategy as they become available. And preparation for phase three initiation during the second quarter, we completed the big defense meetings with the CROs being considered for the phase three studies and launched the manufacturing campaign to support phase three.

Speaker Change: While the FDA had indicated it anticipated providing additional feedback during the second quarter on the phase three design, which would be the first ever phase three pivotal study of a therapeutic candidate for the treatment of arousal disorder in women.

Speaker Change: Its review is ongoing, and we look forward to providing updates on the FDA's feedback, the Phase 3 study design and plans, as well as any relevant updates on our collaboration strategy as they become available.

Sabrina Martusi Johnson: In preparation for the initiation of Phase III, during the second quarter, we completed the bid defense meetings with the CROs being considered for the Phase III studies and launched the manufacturing campaign to support Phase III. In terms of market and revenue potential, there are currently no FDA-approved treatments for any form of sexual arousal disorder in the United States. Meaningful Benefil Cream has the potential to be the first. Denafil 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, and market research suggests that approximately 20 million women in the U.S. experience symptoms of low or no sexual arousal.

Speaker Change: In preparation for Phase 3 initiation, during the second quarter, we completed the bid defense meetings with the CROs being considered for the Phase 3 studies and launched the manufacturing campaign to support Phase 3.

Sabrina Johnson: In terms of market and revenue potential, there are currently no FDA-approved treatments for any form of sexual arousal disorder in women. Meaning Sydenicel Cream has the potential to be the first. Sydenicel is the active ingredient in tablet form for oil 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. Market research suggests that approximately 20 million women in the US experience symptoms of low or no sexual arousal. In terms of probability of success, we've already demonstrated that Sydenicel Cream increased general blood tissue flow in quantitative studies, and as we previously shared, we've completed all of the study analyses and data from the exploratory phase to the respond clinical trial of Sydenicel Cream and identified the patient population that received the greatest benefit from Sydenicel Cream in their general arousal response.

Sabrina Johnson: In terms of market and revenue potential, there are currently no FDA-approved treatments for any form of sexual arousal disorder in women. Meaningful Benefil Cream has the potential to be the first. Zodenafil 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: In terms of market and revenue potential, there are currently no FDA-approved treatments for any form of sexual arousal disorder in women, meaning Civenafil cream has the potential to be the first.

Speaker Change: The Denafil 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.

Sabrina Johnson: And market research suggests that approximately 20 million women in the U.S. experience symptoms of low or no sexual arousal. In terms of probability of success, we've already demonstrated that Sevenafilcream increased genital blood flow in quantitative studies. And as we previously shared, we've completed all of the study analyses and data from the exploratory Phase 2b RESPOND clinical trial of sevenafilcream and identified the patient population that received the greatest benefit from SusanaPhil cream in their genital arousal response.

Speaker Change: And market research suggests that approximately 20 million women in the U.S. experience symptoms of low or no sexual arousal.

Sabrina Martusi Johnson: In terms of probability of success, we've already demonstrated that sedentafil cream increased genital blood flow in quantitative studies. And, as we previously shared, we've completed all of the study analyses and data from the Exploratory Phase 2b RESPOND clinical trial of sedentafil cream and identified the patient population that received the greatest benefit from Susanafil in their genital arousal response. The efficacy findings and details regarding this patient population were published in the Journal of Obstetrics and Gynecology, which is the official journal of the American College of Obstetrics and Gynecology, or ACOG, and were available open access online in June. Our publication was featured as the featured article in July for In the Green Room, which is the ACOG podcast. Our study was also spotlighted in an editorial in the.

Speaker Change: In terms of probability of success, we've already demonstrated that sedentafil cream increased genital blood tissue flow.

Speaker Change: in quantitative studies. And as we previously shared, we've completed all of the study analyses and data from the exploratory face-to-be-respond clinical trial of sudenafil cream and identified the patient population that received the greatest benefit from sudenafil cream in their genital arousal response.

Sabrina Johnson: The efficacy findings and details regarding this patient population were published in the Journal of Obstetrics and Gynecology, which is the official journal of the American College of Obstetrics and Gynecology, or ACOG. And were available open access online in June. And our publication was featured as the featured article in July for In the Green Room, which is the ACOG podcast. Our study was also spotlighted in an editorial in the journal. It's a distinct honor to be featured, and we are pleased to see the medical community selling engaged in these first of its kind data, ran such a significant unmet need.

Sabrina Johnson: The efficacy findings and details regarding this patient population were published in the Journal of Obstetrics and Gynecology, which is the official journal of the American College of Obstetrics and Gynecology, or ACOG, and were available open access online in June. Our publication was featured as the featured article in July for In the Green Room, which is the ACOG podcast. Our study was also spotlighted in an editorial in The Journal. It's a distinct honor to be featured, and we are pleased to see the medical community so engaged in these first-of-its-kind data around such a significant unmet need. We look forward to providing additional updates on the development program as they become available.

Speaker Change: The efficacy findings and details regarding this patient population were published in the Journal of Obstetrics and Gynecology Which is the official journal of the American College of Obstetrics and Gynecology or ACOG

Speaker Change: And we're available open access online in June.

Speaker Change: And our publication was featured as the featured article in July for In the Green Room, which is the ACOG podcast.

Speaker Change: Our study was also spotlighted in an editorial in the journal. It's a distinct honor to be featured and we are pleased to see the medical community so engaged in these first-of-its-kind data around such a significant unmet need.

Sabrina Martusi Johnson: It's a distinct honor to be featured, and we are pleased to see the medical community so engaged in these first-of-its-kind data around such a significant unmet need. We look forward to providing additional updates on the development program as they become available. In terms of Ovaprene, we also want to provide an update on the progress of the Phase 3 study of Ovaprene, which is our novel, investigational, hormone-free, monthly, intravaginal, contraceptive for which U.S. commercial rights are under a license agreement with

Sabrina Johnson: We look forward to providing additional updates on the development program as they are available.

Speaker Change: We look forward to providing additional updates on the development program as they are available.

Sabrina Johnson: In terms of overpring, we also want to provide an update on the advancement of the phase 3 study of overpring, which is our novel investigational hormone-free monthly international contraceptive, whose US commercial rights are under a license agreement with Dare. Non-commono contraception represents a significant commercial market opportunity, as there are currently no monthly hormone-free contraceptives approved by the FDA. Overpring has potential to be a disruptive product in the contraceptive category, and an important option for women who cannot use hormone-based birth control products, or prefer not to do so. Based on market research, approximately 35 million women in the US are potential candidates for overpring.

Sabrina Johnson: In terms of Ovaprene, we also want to provide an update on the progress of the Phase 3 study of Ovaprene, 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 as 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.

Speaker Change: In terms of Ovapreen, we also want to provide an update on the advancement of the Phase 3 study of Ovapreen, which is our novel investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer.

Sabrina Martusi Johnson: Non-hormonal contraception represents a significant commercial market opportunity, as there are currently no monthly hormone-free contraceptives approved by the FDA. Overprine 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.

Speaker Change: Non-hormonal contraception represents a significant commercial market opportunity as there are no currently no monthly hormone-free contraceptives approved by the FDA.

Speaker Change: Overpraying has 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 Martusi Johnson: Based on market research, approximately 35 million women in the U.S. are potential candidates for Obamacare. Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, of the National Institutes of Health, or NIA, We commenced patient enrollment in the Evergreen Pivotal Phase 3 clinical study in December of 2020, and recruitment is currently underway at 20 sites across the United States. And it's supported by a central advertising campaign for the study that launched in March of this year, March 2020. You can see the campaign materials by visiting our homepage.

Sabrina Johnson: Based on market research, approximately 35 million women in the U.S. are potential candidates for OBC. Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, of the National Institutes of Health, or NIAH, We commenced patient enrollment in the Evergreen Pivotal Phase 3 clinical study in December of 2020. Recruitment is currently underway at 20 sites across the United States, and it's supported by a central advertising campaign for the study that launched in March of this year, March twenty-two.

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

Sabrina Johnson: Working with study collaborators at the UNIS Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, of the National Institutes of Health, or NIH, recommence patient enrollment in the other pre-pivotal Phase 3 clinical study in December of 2023. Recruitment is currently underway at 20 sites across the United States, and it's supported by a central advertising campaign for the study that launched in March of this year, March 2024. You can see the campaign materials by visiting our website homepage. While there are 20 sites currently recruiting, it's clear that a subset of approximately half of those sites are the most successful in translating into study participants that considerable interest we have seen from women in response to the central advertising campaign.

Speaker Change: Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, of the National Institutes of Health, or NIH, we commenced patient enrollment in the Evergreen Pivotal Phase III clinical study in December of 2023.

Speaker Change: Recruitment is currently underway at 20 sites across the United States and it's supported by a central advertising campaign for the study that launched in March of this year, March 2024. You can see the campaign materials by visiting our website homepage.

Sabrina Johnson: You can see the campaign materials by visiting our website. While there are 20 sites currently recruiting, it's clear that a subset of approximately half of those sites is the most successful in translating the considerable interest we have seen from women in response to the central advertising. As a result, we have a range of enrollment projections that vary considerably based on the enrollment rates at our most successful sites versus those that are not enrolling at a similar pace.

Sabrina Martusi Johnson: While there are 20 sites currently recruiting, it's clear that a subset of approximately half of those sites are the most successful in translating the considerable interest we have seen from women in response to the central advertising. As a result, we have a range of enrollment projections that vary considerably based on the enrollment rates at our most successful sites versus those that are not enrolling at a similar site. As a reminder, this study aims to enroll sufficient participants across the study sites to have approximately 250 participants complete approximately 12 months, which is 13 menstrual cycles, of treatment, based on the current average enrollment rate across all of the 20 states. We anticipate that approximately 125 women will attend, which is half of our target number of participants. Feet to Stadby will complete approximately six months of product use by the end of the second quarter of 2025.

Speaker Change: While there are 20 sites currently recruiting, it's clear that a subset of approximately half of those sites are the most successful in translating into study participants that considerable interest we have seen from women in response to the central advertising campaign.

Sabrina Johnson: As a result, we have a range of enrollment projections that vary considerably based on the enrollment rates at our most successful sites versus those that are not enrolling at a similar pace. As a reminder, the study aims to enroll sufficient participants across the study sites to have approximately 250 participants complete approximately 12 months, which is 13 menstrual cycles of product use. Based on the current average enrollment rate across all of the 20 sites, 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 product used by the end of the second quarter in 2025.

Speaker Change: As a result, we have a range of enrollment projections that vary considerably based on the enrollment rates at our most successful sites versus those that are not enrolling at a similar pace.

Sabrina Johnson: As a reminder, this study aims to enroll sufficient participants across the study sites to have approximately 250 participants complete approximately 12 months, which is 13 menstrual cycles, of product development. Based on the current average enrollment rate across all of the 20 sites, we anticipate that approximately 125 women, which is half of our target number of participants, Lisa Walters, MarDee Haring, John Fair, Catherine Novack, MarDee Haring, Dare Bioscience, We are, of course, looking at strategies to ensure that all of the study sites are equally successful and productive, and look forward to providing updates on enrollment projections and rates as enrollment progresses in the coming quarter.

Speaker Change: As a reminder, this study aims to enroll sufficient participants across the study sites to have approximately 250 participants complete approximately 12 months, which is 13 menstrual cycles, of product use.

Speaker Change: Based on the current average enrollment rate across all of the 20 sites,

Speaker Change: We anticipate that approximately 125 women, which is half of our target number of participants.

Speaker Change: to complete the study, will complete approximately six months of product use by the end of the second quarter in 2025.

Sabrina Johnson: We are, of course, looking at strategies to ensure that all of the study sites are equally successful and productive, and look forward to providing updates on enrollment projections and rates as enrollment progresses in the coming quarters. Based on communications to date with the FDA, if successful, we believe that just this single registration study will be required to support a pre-market approval application submission with the FDA.

Sabrina Martusi Johnson: We are, of course, looking at strategies to ensure that all of the study sites are equally successful and productive and look forward to providing updates on enrollment projections and rates as enrollment progresses in the coming quarter. Based on communications to date with the FDA, if successful, we believe that just this single registration study will be required to support a premarket approval application with the FDA. I'd now like to turn to Dare HRT1 and Dare VBA because, lastly, given the unveiling earlier this year of a bipartisan Senate bill that would authorize $275 million to boost research, training, and public awareness around menopause and midlife women's health, an area that has often been too stigmatized, overlooked, and underfunded, we've been getting lots of questions about our menopause-related programs. Dare HRT1 is a potential first vaginal monthly therapy for the vasomotor symptoms of menopause.

Speaker Change: We are, of course, looking at strategies to ensure that all of the study sites are equally successful and productive, and look forward to providing updates on enrollment projections and rates as enrollment progresses in the coming quarters.

Sabrina Johnson: Based on communications to date with the FDA, if successful, we believe that just this single registration study will be required to support a premarket approval application submission with the FDA. I'd now like to turn to Dare HRT1 and Dare VBA. Because lastly, given the unveiling earlier this year of a bipartisan Senate bill that would authorize $275 million to boost research, training, and public awareness around menopause and midlife women's health issues, an area that has often been too stigmatized, overlooked, and underfunded, we've been getting lots of questions about our menopause-related programs.

Speaker Change: Based on communications to date with the FDA, if successful, we believe that just this single registration study will be required to support a premarket approval application submission with the FDA.

Sabrina Johnson: I now like to turn to dare HRT1 and dare VVA1 because lastly, given the unveiling earlier this year of a bipartisan Senate bill that would authorize 275 million to boost research, training, and public awareness around metaphors and mid-life women's health issues. An area that has often been too stigmatized, overlooked, and underfunded. We've been getting lots of questions about our menopause-related programs. Dare HRT1 is a potential first vaginal monthly therapy for the days and motor symptoms of menopause. This is a program we are preparing for the single phase three clinical study we believe will be required for approval via the FDA's 505(b)(2) pathway.

Speaker Change: I'd now like to turn to DARE HRT1 and DARE VVA1.

Speaker Change: Lastly, given the unveiling earlier this year of a bipartisan Senate bill that would authorize $275 million to boost research, training, and public awareness around menopause and midlife women's health issues.

Speaker Change: An area that has often been too stigmatized, overlooked, and underfunded, we've been getting lots of questions about our menopause-related programs.

Sabrina Johnson: Their HRT-1 is a potential first vaginal monthly therapy for the vasomotor symptoms of menopause. This is a program we are preparing for the single Phase III clinical study we believe will be required for approval via the FDA's 505B2 pathway. In addition, Dare VBA 1, which is our hormone-free vaginal candidate for sexual use due to the vulvar and vaginal atrophy, or VVA, associated with menopause, is phase two ready, and we're actively exploring opportunities to move this program forward.

Speaker Change: Their HRT-1 is a potential first vaginal monthly therapy for the vasomotor symptoms of menopause. This is a program we are preparing for the single phase three clinical study we believe will be required for approval via the FDA's 505 B2 pathway.

Sabrina Martusi Johnson: This is a program we are preparing for the single Phase 3 clinical study we believe will be required for approval via the FDA's 505B2 pathway. In addition, Dare VBA 1, which is our hormone-free vaginal candidate for sexual use due to the vulvar and vaginal atrophy, or VVA, associated with menopause, is phase two ready, and we're actively exploring opportunities to move this program forward. We're looking forward to seeing continued progress in the menopause space and the potential progress of this new bill, and we'll provide updates on our DARE-HRT1 and DARE-VDA1 programs as available.

Sabrina Johnson: In addition, dare VVA1, which is our hormone-free vaginal candidate for sexual pain due to the vulgar vaginal atrophy or VVA associated with menopause, is phase two ready, and we're actively exploring opportunities to move this program forward. We're looking forward to seeing continued progress in the menopause phase and potential progress of this new bill and will provide updates on our dare HRT1 and dare VVA1 programs as available.

Speaker Change: In addition, DARE-VVA-1, which is our hormone-free vaginal candidate for sexual pain due to the vulvar and vaginal atrophy, or VVA, associated with menopause, is Phase II ready, and we're actively exploring opportunities to move this program forward.

Sabrina Johnson: We're looking forward to seeing continued progress in the menopause space and potential progress with this new bill, and we'll provide updates on our DARE-HRT1 and DARE-VDA1 programs as available. In summary, we continue to progress our portfolio of potential first-in-category product candidates and look forward to providing more updates this year 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 Zosciato and Bayer for Ovaprene, to commercialize and deliver these treatments to as many women as possible. I'd now like to turn the call over to the operator for Q&A. Thank you. We will now begin the question and answer session.

Speaker Change: We're looking forward to seeing continued progress in the menopause space and potential progress of this new bill, and we'll provide updates on our DARE HRT-1 and DARE VDA-1 programs as available.

Sabrina Johnson: In summary, we continue to progress our portfolio of potential first and category product candidates and look forward to providing more updates this year as we work to advance some of the most potentially disruptive candidates for the health and well-being of women in decades, collaborating with leading companies, including Oregon on Frisciado and Bayer for overpring to commercialize and deliver these treatments to as many women as possible.

Sabrina Martusi Johnson: In summary, we continue to progress our portfolio of potential first-in-category product candidates and look forward to providing more updates this year 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 Zosciato and Bayer for Ovaprene, to commercialize and deliver these treatments to as many women as possible. I'd now like to turn the call over to the operator for Q&A.

Speaker Change: In summary, we continue to progress our portfolio of potential first-in-category product candidates and look forward to providing more updates this year as we work to advance some of the most potentially disruptive candidates for the health and well-being of women in decades.

Speaker Change: Collaborating with leading companies, including Organon for Zosciato and Bayer for Obiprene, to commercialize and deliver these treatments to as many women as possible.

Unknown Executive: I'd now like to turn the call over to the operator for Q&A. Thank you. We will now begin the question and answer session. At this time, I would like to remind everyone that in order to ask a question, press the star and then the number one on your telephone keypad. If you are called to ask your question and are listening by a loudspeaker on your device, please pick up your handset and ensure that your phone is not on with when asking your question.

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

Operator: Thank you. We will now begin the question and answer session. At this time, I would like to remind everyone that in order to ask a question, press the star and then the number one on your telephone keypad. If you are called upon to ask your question and are listening through a loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. We will pause for a moment to compile the question and answer roster. Your first question comes from the line of Catherine Novack of Jones Research. Please go ahead.

Sabrina Martusi Johnson: Thank you. We will now begin the question and answer session. At this time, I would like to remind everyone that in order to ask a question, press the star and then the number one on your telephone keypad. If you are called upon to ask your question and are listening through a loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question.

Speaker Change: Thank you. We will now begin the question and answer session. At this time, I would like to remind everyone in order to ask a question, press the star and then the number one on your telephone keypad.

Speaker Change: If you are called upon to ask your question and are listening by a loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question.

Unknown Executive: We will post for a moment to confide the question and answer roster.

Operator: We will pause for a moment to compile the question and answer roster. Your first question comes from the line of Catherine Novack of Jones Research. Please go ahead. Hi, good afternoon.

Speaker Change: We will pause for a moment to compile the question and answer roster.

Speaker Change: [inaudible]

Speaker Change: Episode 2

Catherine Novack: Your first question comes from the line of Catherine Novak of Jones Research. Please go ahead. Hi. Good afternoon. Congrats on all the progress this quarter. I wanted to ask again for overprinting. With the timing updates that you gave today, can you give us a sense of what implications this has for top-line readout? And then, given that this is single arm, do you have any plans for an interim look so we can see data a little bit sooner? Yeah, absolutely. There's a great question. We don't have timing yet for top line. You know, as I mentioned in the prepared remarks, there's a difference in enrollment rate between some of the sites.

Speaker Change: Your first question comes from the line of Katherine Novak of Jones Research. Please go ahead.

Catherine Novack: Congratulations on all the progress this quarter. I wanted to ask again about overprinting. With the timing updates that you gave today, can you give us a sense of what implications this has for top line readout? And then, given that this is single-arm, do you have any plans for an interim look so we can see data a little bit sooner? Yeah, absolutely. Those are great questions.

Catherine Novack: Hi, good afternoon. Congratulations on all the progress this quarter. I wanted to ask again about overprinting. With the timing updates that you gave today, can you give us a sense of what implications this has for top line readout? And then, given that this is single-arm, do you have any plans for an interim look so we can see data a little bit sooner? Yeah.

Katherine Novak: Hi, good afternoon. Congrats on all the progress this quarter. I wanted to ask again for overprinting.

Katherine Novak: With the timing updates that you gave today, can you give us a sense of what implication this has for top line readout? And then given that this is single arm, do you have any plans for an interim look so we can see data a little bit sooner?

Sabrina Johnson: Yeah, absolutely. Those are great questions.

Sabrina Martusi Johnson: We don't have timing yet for top line, you know, as I mentioned in the prepared remark. There's a difference in enrollment rates between some of the sites, and I want to be clear, there's not a difference in demand. So the central advertising campaign has been quite successful in terms of generating patient interest in the study quite equitably across the sites. There is just a difference in terms of how successful some of the sites are turning those women into study participants from that considerable interest.

Speaker Change: Yeah, absolutely. Those are great questions. We don't have timing yet for top line, you know, as I mentioned in the prepared remarks.

Sabrina Johnson: We don't have timing yet for top line. You know, as I mentioned in the prepared remarks, there's a difference in enrollment rates between some of the sites, and I want to be clear, there's not a difference in demand. So the central advertising campaign has been quite successful in terms of generating patient interest in the study quite equitably across the sites. There is just a difference in terms of how successful some of the sites are turning those women into study participants from that considerable interest.

Sabrina Johnson: And I want to be clear there's not a difference in demand. So the central advertising campaign has been quite successful in terms of generating patient interest in the study quite effectively across the site. It's just a difference in terms of how successful some of the sites are translating those the women into study participants from that considerable interest. And so we feel comfortable at this time, projecting when we'll have right half of the subjects having completed about halfway through right six months of their assessment. We definitely look forward to giving more updates, including an opportunity to do an interim analysis at that point.

Speaker Change: There's a difference in enrollment rate between some of the sites. And I want to be clear, there's not a difference in demand. So the central advertising campaign has been quite successful in terms of generating patient interest in the study.

Speaker Change: quite equitably across the sites. It's just a difference in terms of how successful some of the sites are translating the women into study participants.

Sabrina Johnson: And so we feel comfortable at this time projecting when we'll have, right, half of the subjects having completed about halfway through, right, six months of their assessments. We definitely look forward to giving more updates, including an opportunity to do an interim analysis at that point. But we're not prepared yet to give exact timing on the final top line. We really want to get a little further in enrollment and a little further in, you know, looking at some of these strategies we've been implementing to help all the sites be equally successful and productive in pulling those patients that have expressed interest forward.

Speaker Change: from that considerable interest. And so we feel comfortable at this time projecting when we'll have, right, half of the subjects having completed about halfway through, right, six months of their assessments.

Sabrina Martusi Johnson: And so we feel comfortable at this time projecting when we'll have, right, half of the subjects having completed about halfway through, right, six months of their assessments. We definitely look forward to giving more updates, including an opportunity to do an interim analysis at that point. But we're not prepared yet to give exact timing on the final top line.

Speaker Change: We definitely look forward to giving more updates, including an opportunity to do an interim analysis at that point, but we're not prepared yet to give exact timing on final top line. We really want to get a little further in enrollment and a little further in looking at some of these strategies we've been implementing to help all the sites be equally successful and productive in pulling those patients that have expressed interest forward.

Sabrina Johnson: But we're not prepared yet to give exact timing on final top line. We really want to get a little further in enrollment and a little further in, you know, looking at some of these strategies we've been implementing to help all the sites be equally successful. Productive, and pulling those patients that have expressed interest forward.

Sabrina Martusi Johnson: We really want to get a little further in enrollment and a little further in, you know, looking at some of these strategies we've been implementing to help all the sites, the Access Fund for Access, in pulling those patients that have expressed interest forward. Great. And then again, since this is a single-arm, can you remind us the typical use of the Pearl Index that would make this, you know, a commercially compelling asset? Yeah, it's a great question.

Sabrina Johnson: Great. And then again, since this is single arm, can you remind us that typical use Pearl Index that you that would make this, you know, commercially compelling asset? Yeah, it's a great question. So the non hormonal category for crunch, so for first of all, I should take a step back. So Pearl index is how contraceptive methods are evaluated by the FDA, and it's the metrics that use regardless of whether it's a hormonal product or a non hormonal product. And FDA-approved products have a very wide range of pearl indices. So most effective is one that's like an intrauterine device, right, which is implanted.

Sabrina Johnson: Great. And then again, since this is a single arm, can you remind us the typical use of the Pearl index that would make this, you know, a commercially compelling asset?

Speaker Change: Great. And then again, since this is single arm, can you remind us the typical use pearl index that you that would make this, you know, commercially compelling asset?

Sabrina Johnson: Yeah, it's a great question. So the non-hormonal category for, first of all, I should take a step back. So the Pearl Index is how contraceptive methods are evaluated by the FDA. And it's the metrics that's used regardless of whether it's a hormonal product or a non-hormonal product. And FDA-approved products have a very wide range of Pearl Index values.

Sabrina Martusi Johnson: So, the non-hormonal category for, first of all, I should take a step back. The Pearl Index is how contraceptive methods are evaluated by the FDA, and it's the metrics that's used regardless of whether it's a hormonal product or a non-hormonal product. And FDA-approved products have a very wide range of the Pearl Index. So, the most effective is one that's like an intrauterine device, right, which is implanted. And the least effective of the FDA-approved methods are spermicides or vaginal gels, which have a Perl index of 27 to 28.

Speaker Change: Yeah, it's a great question. So the non-hormonal category for, so first of all, I should take a step back. So Pearl Index is how contraceptive methods are evaluated by the FDA and it's the metrics that's used regardless of whether it's a hormonal product or a non-hormonal product.

Speaker Change: FTE approved products have a very wide range of PIRL indices.

Sabrina Johnson: So, the most effective is one that's like an intrauterine device, right, which is implanted. And the least effective of the FDA-approved methods are spermicides or vaginal gels, which have a Perl index of 27 to 28. So, it's a very broad range, and in the non-hormonal category, there really are not that many options, and the options that are available, other than the copper IUD, which is in that one range, the other options are at the other end of the spectrum, closer to the 27 to 28, or are in the 27 to 28 range.

Speaker Change: So most effective is one that's like an intrauterine device, right, which is implanted. And the least effective of the FDA approved methods are the spermicides or vaginal gels which have a Perl index in the 27 to 28 range.

Sabrina Johnson: And the least effective of the FDA-approved methods are the thermocides of vaginal gels, which have a Pearl index in the 27 to 28 range. So it's a very broad range. And in the non-hormonal category, there really are not that many options, and the options that are available other than the upper IUD, which is in that one range. The other options are at the other end of the spectrum, closer to the 27 to 28, or are the 27 to 28 range. So as we think about a product like Overpring, it would be the first product to be a once a month.

Sabrina Martusi Johnson: So, it's a very broad range, and in the non-hormonal category, there really are not that many options, and the options that are available, other than the copper IUD, which is in that one range, the other options are at the other end of the spectrum, closer to the 27 to 28, or are in the 27 to 28 range. As we think about a product like Ovaprene, it would be the first product to be once a month, so all the other non-hormonal products other than the copper IUD are peri-coital, meaning they're used in the method. Think condoms, think spermicide, so it would be different in that regard.

Speaker Change: So it's a very broad range and in the non-hormonal category, there really are not that many options and the options that are available other than the copper IUD, which is in that one.

Speaker Change: range. The other options are at the other end of the spectrum, closer to the 27 to 28, or are the 27 to 28 range. So,

Sabrina Johnson: As we think about a product like Ovaprene, it would be the first product to be once a month, so all the other non-hormonal products other than the copper IUD are peri-coital, meaning they're used in the method. Think condoms, think spermicide, so it would be different in that regard. And based on the... Pre-Pivotal Study data that's been generated, that study suggests that the surrogate marker that's been used for that study of contraceptive effectiveness has the potential to be in the same range as the hormonal methods, the short-acting hormonal methods, like pills, patches, and rings.

Speaker Change: As we think about a product like Ovaprene, it would be the first product to be a once a month. So all the other non-hormonal products other than the copper IUD are.

Sabrina Johnson: So all the other non-hormonal products that are in the upper IUD are pericoidal, meaning they're used in the method. Think condoms, think from the side. So it would be different in that regard. And based on the pre-pivotal study data that's been generated, that study suggests that the surrogate marker that's used for that study and contraceptive effectiveness, that it has the potential to be in the same range. As the hormonal methods, the short acting hormonal methods like pills, patches, rings. But the bar is fairly low, right, for the non-hormonal methods given what some of the other approved products are.

Speaker Change: Pericoidal, meaning they're used in the method, think condoms, think formicide. So it would be different in that regard. And based on the

Sabrina Martusi Johnson: And based on the... Pre-Pivotal Study data that's been generated, that study suggests that the surrogate marker that's been used for that study of contraceptive effectiveness has the potential to be in the same range as the hormonal methods, the short-acting hormonal methods like pills and patches. But the bar is fairly low, right, for the non-hormonal methods, given what some of the other approved products are. And that really means, from an acceptability perspective, there's really a wide range of efficacy that could be very acceptable for a method like Ovaprene, given that it also has convenience that none of the other non-hormonal methods have.

Speaker Change: pre-pivotal study data that's been generated, that study suggests that the surrogate marker that's used for that study in contraceptive effectiveness, that it has the potential to be in the same range as the hormonal methods, the short-acting hormonal methods, like pills, patches, rings.

Unknown Executive: Good afternoon and welcome to the Dare Bioscience financial results and business update call for the quarter ended June 30th, 2024. Today we will review our second quarter results and discuss developments and expectations for our pipeline and portfolio.

Sabrina Johnson: But the bar is fairly low, right, for the non-hormonal methods, given what some of the other approved products are. And that really means, from an acceptability perspective, there's really a wide range of efficacy that could be very acceptable for a method like Oviprene, given that it also has convenience that none of the other non-hormonal methods have. So the pre-pivotal data suggests that it has the opportunity for effectiveness in the same range as the short-acting or hormonal methods.

Speaker Change: But the bar is.

Unknown Executive: I'd like to remind you that today's discussion will include forward looking statements within the meeting of federal securities laws which are made pursuant to the safe harbor provisions of the private security litigation reform act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties.

Speaker Change: fairly low, right, for the non-hormonal methods, given what some of the other approved products are. And that really means, from an acceptability perspective, there's really a wide range of efficacy that could be very acceptable for a method like Ovaprene, given that it also has convenience.

Sabrina Johnson: And that really means, from an acceptability perspective, there's really a wide range of efficacy that could be very acceptable for methods like overpring, given that it also has convenience. But none of the other non-hormonal methods have. So the pre-pivotal data suggests that it has that opportunity for effectiveness in the same range as the short-acting hormonal methods. And then to your question, Catherine, the range in general, though, for non-hormonal methods is actually quite wide, which really speaks to you in the end. And you know, it's all about contraceptive methods that women will use. And that's why the FDA has approved such a wide range of contraceptive effectiveness.

Sabrina Martusi Johnson: So the pre-pivotal data suggests that it has that opportunity for effectiveness in the same range as the short-acting or hormonal methods. And then, to your question, Catherine, the range, in general, though for non-hormonal methods is actually quite wide, which really speaks to, in the end, you know, what it's all about. Contraceptive methods that women will use, and that's why the FDA has approved such a wide range of contraceptive effectiveness. So there is a wide range, therefore, of acceptability and commercial viability for products like Ovaprim, particularly given that it would be the only once-a-month method that's available, right, non-pericordial method or non-implanted method that would be available in the hormone-free category.

Speaker Change: But none of the other non-hormonal methods have.

Speaker Change: So the pre-pivotal data suggested it has that opportunity for effectiveness in the same range as the short-acting or hormonal methods. And then to your question, Catherine, the range in general, though, for non-hormonal methods is actually quite wide.

Sabrina Johnson: And then to your question, Catherine, the range, in general, though, for non-hormonal methods is actually quite wide, which really speaks to, in the end, you know, it's all about contraceptive methods that women will use, and that's why the FDA has approved such a wide range of contraceptive effectiveness. So there's a wide range, therefore, of acceptability and commercial viability for products like Oviprene, particularly given that it would be the only once-a-month method that's available, right, non-pericordial method or non-implanted method that would be available in the hormone-free category.

Unknown Executive: 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 on form 10Q for the quarter ended June 30th, 2024 which was filed today.

Speaker Change: which really speaks to in the end, you know, it's all about.

Speaker Change: Contraceptive methods that women will use, and that's why the FDA has approved such a wide range of contraceptive effectiveness. So there's a wide range, therefore, of acceptability and commercial viability for a product like Ovaprene, particularly given that it would be the only once a month method that's available, non-pericordial method or non-implanted method that would be available in the hormone-free category.

Unknown Executive: I would also like to point out that the content of this call includes time sensitive information that is current as of today, August 12th, 2024. 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 Johnson: So there's a wide range, therefore, of acceptability and commercial viability for products like overpring, particularly given that it would be the only once-a-month method that's available, right. Non pericordal method or non implanted method that would be available in the hormonal free category.

Unknown Executive: I will now turn it over to Sabrina. Thank you.

Catherine Novack: This is great. That's helpful. Thank you. Looking forward to getting more updates from the program down the line. Absolutely. Thank you.

Operator: Great, that's helpful. Thank you. Looking forward to getting more updates from the program down the line. Absolutely. Thank you. Again, if you would like to ask a question, press the star and then the number one on your telephone keypad.

Sabrina Johnson: Great, that's helpful. Thank you. Looking forward to getting more updates from the program down the line.

Sabrina Johnson: I always like to start our quarterly calls by taking a minute to remind those of you who may be newer to the Dari story of our purpose and our mission. We believe Dari 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 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.

Speaker Change: Great, that's helpful. Thank you. Looking forward to getting more updates from the program down the line.

Sabrina Johnson: Absolutely. Thank you.

Speaker Change: Absolutely. Thank you.

Douglas Tsao: Again, if you would like to ask a question, press the star and then the number one on your telephone keypad. Here, next question comes from the line up: Douglas Tsao of HC, Wayne Wright, and Cole. Please go ahead. Hi, good afternoon. Nice to have you. Thank you for taking the questions. I guess Sabrina, in terms of your interactions with the FDA for this event also, a cream program.

Operator: Again, if you would like to ask a question, press the star and then the number one on your telephone keypad. Your next question comes from the line of Douglas Tsao of HC Wainwright & Co. Please go ahead.

Speaker Change: Again, if you would like to ask a question, press the star and then the number one on your telephone keypad. Your next question comes from the line of Douglas Chow of HC Wainwright & Co. Please go ahead.

Douglas Tsao: Your next question comes from the line of Douglas Tsao of HC Wainwright & Co. Please go ahead. Hi, good afternoon.

Douglas Tsao: Hi, good afternoon. Thanks for taking the questions. I guess, Sabrina, in terms of your interactions with the FDA for this event and the CREAM program, I guess, I'm just curious, are you... Unknown Speaker 06.10.15, anticipating another meeting being needed to sort of get this final alignment, or do you think your sort of interactions are sufficient to get this settled?

Douglas Tsao: Thanks for taking the questions. I guess, Sabrina, in terms of your interactions with the FDA for this adenosyl screen program, I guess, I'm just curious, are you... Unknown Speaker 00.00.00.00, anticipating another meeting being needed to sort of get this final alignment, or do you think your sort of interactions are sufficient to get this settled? Yeah, that's a great question.

Sabrina Johnson: I guess I'm just curious, are you anticipating another meeting being needed to sort of get this final alignment, or do you think your sort of interactions are sufficient to get this settled? Yeah, that's a great question. You know, it's definitely clear that, which we know, right, this is a first and category indication and a first and category product. And there's a lot of data for the FDA to go through. And there's also a lot of kind of key opinion leader support that we have provided to the FDA historically, right in terms of understanding of the indication, understanding of the outcome measures.

Douglas Chow: Anticipating another meeting being needed to sort of get this final alignment or do you think your sort of interactions are sufficient to get this settled?

Sabrina 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 previously been applied to the indication in question for women. We believe we have the broadest portfolio of potential high-impact first-in-category product candidates to improve the health and well-being of women, many of which have already demonstrated proof of concept and that our robust pipeline positions as well for the short, medium, and long-term.

Sabrina Johnson: Yeah, that's a great question. Um, you know, it's, it's definitely ** This is a test. Also, a lot of the kind of key opinion leader support that we have provided to the FDA historically, right, in terms of understanding of the indication, understanding of the outcome measures. So, you know, there may be questions or circumstances where that's helpful, but it's not clear at this time. Right now, the questions have really been straightforward in terms of, you know, kind of the typical things we're providing a lot of, as I said, information around those outcome measures and what's a clinically meaningful improvement. And there's a whole very specialized assessment in the patient-reported outcome world called the psychometric analysis and assessment that was done.

Sabrina Martusi Johnson: Um, you know, it's definitely, Make it clear, this is a first in category indication and a first in category product. And there's a lot of data for the FDA to go through, and there's also a lot of data. Kind of key opinion leader support that we have provided to the FDA historically, right, in terms of understanding of the indication, understanding of the outcome measures. So, you know, there may be questions or circumstances where that's helpful, not clear at this time.

Speaker Change: Yeah, Doug, that's a great question. Um, you know, it's it's definitely

Speaker Change: clear that, which we know, right, this is a first-in-category indication and a first-in-category product. And there's a lot of data for the FDA to go through. And there's also a lot of

Speaker Change: Kind of key opinion leader support that we have provided to the FDA historically, right? In terms of understanding of the indication, understanding of the outcome measures.

Sabrina Johnson: During our last update call, we discussed the strides we made last year to advance innovative therapies for women and the key milestone anticipated for 2020, in 2004. In addition to the continued commercialization of Zashiyato, Clinton, Mayas, and Foss State, Vaginal Gel, 2%, the first FDA approved product to emerge from our portfolio and a treatment for bacterial vaginosis in female aged 12 and older that became available nationwide by prescription earlier this year via our collaborator organon.

Sabrina Johnson: So, you know, there may be questions or circumstances where that's helpful, not clear at this time. Right now, the questions have really been straightforward in terms of, you know, kind of the typical things where we're providing a lot of, as I said, information around those outcome measures and what's the clinically meaningful improvement. There's a whole very specialized assessment in the patient-reported outcome world called the psychometric. Analysis and assessment that was done, so a lot of the information we're providing is really providing that color.

Speaker Change: So, you know, there may be questions or circumstances where that's helpful.

Sabrina Martusi Johnson: Right now, the questions have really been straightforward in terms of, you know, kind of the typical things we're providing a lot of, as I said, information around those outcome measures and what's a clinically meaningful improvement. And there's a whole very specialized assessment in the patient-reported outcome world called the psychometric analysis and assessment that was done.

Speaker Change: Not clear at this time. Right now, the questions have really been straightforward in terms of, you know, kind of the typical things we're providing a lot of, as I said, information around those outcome measures and what's the clinically meaningful improvement and.

Sabrina Johnson: We also discussed anticipated milestones, focused on our first and category product candidates related to continuing to progress toward a phase 3 trial of Savannah Phil Cream, 3.6%, which has the potential to be the first FDA approved treatment for female sexual arousal disorder, for which there are now FDA approved treatments, and continuing to enroll in our phase 3 study of OvaPreen, our potentially first and category hormone-free monthly vaginal contraceptive candidate.

Speaker Change: There's a whole very specialized assessment in the patient-reported outcome world called the psychometric analysis and assessment that was done. So a lot of the information we're providing is really providing that color.

Sabrina Martusi Johnson: So a lot of the information we're providing is really providing that color, but once that's determined, you know, we'll definitely be open to that. We have had a number of meetings with the FDA, and when we've had them in the past, they've definitely been super productive. So we're definitely open to that. But at this point, there's nothing definitive about that.

Sabrina Johnson: But to be determined, you know, we'll definitely be open to that. We today have had a number of meetings with the FDA, and when we've had them in the past, they've definitely been super productive, so we're definitely open to that.

Speaker Change: But to be determined, you know, we'll definitely be open to that. We to date have had a number of Meetings with the FDA and when we've had them in the past, they've definitely been super productive. So we're definitely open to that but at this point

Sabrina Johnson: So a lot of the information we're providing is really providing that color, but once that's determined, you know, we'll definitely be open to that. We, to date, have had a number of meetings with the FDA. And when we've had them in the past, they've definitely been super productive. So we're definitely open to that. But at this point, there's nothing definitive enough.

Sabrina Johnson: But at this point, you know, nothing definitive in that front.

Douglas Tsao: Okay, and just, you know, you obviously have a very rich pipeline with a lot of opportunities. I guess, how are you thinking about sort of prioritizing things in the context of your balance sheet and, you know, what you can afford to do right?

Sabrina Johnson: Okay, and just, you know, you obviously have a very rich pipeline with a lot of opportunities. I guess how are you thinking about sort of prioritizing things in the context of your balance sheet and, you know, what you can afford to do right now? Yeah, another great question. And so, as we've, you know, really been trying to highlight over pre and into the NFL, as are two, you know, either in phase three, as the pre and is or getting phase three ready as the NFL is, those have really been our priorities, both operationally, you know, in terms of where we put our bandwidth, but also obviously financially as well.

Douglas Tsao: Okay, and just, you know, you obviously have a very rich pipeline with a lot of opportunities. I guess, how are you thinking about sort of prioritizing things in the context of your balance sheet and, you know, what you can afford to do right? Yeah, another great question.

Speaker Change: You know, nothing definitive in that front.

Sabrina Johnson: Today, we'll review our progress against the anticipated milestones for OvaPreen and Savannah Phil Cream, with the focus on providing context and metrics that are important understanding the potential impact of these programs. We'll also highlight today the status of and what comes next for our two product candidates in the menopause space, our monthly vaginal hormone therapy for hot flashes and our hormone-free vaginal infant for sexual pain.

Speaker Change: Okay, and just, you know, you obviously have a very rich pipeline with a lot of opportunities. I guess, how are you thinking about sort of prioritizing things in the context of your balance sheet and, you know, what you can afford to do right now?

Sabrina Johnson: Yeah, another great question. So, we've, you know, really been trying to highlight OVAPreen and CedenaPhil as our two, either in phase three, as OVAPreen is, or getting phase three ready, as CedenaPhil is. Those have really been our priorities, both operationally, you know, in terms of where we put our bandwidth, but also, obviously, financially as well. And those, you know, those really remain our priority. However, to your point, we have a very deep pipeline, and particularly with a lot of the noise around menopause lately, we've been getting a lot of questions and interest broadly around our menopause programs that we have, the two that I highlighted today.

Sabrina Martusi Johnson: So, as we've, you know, really been trying to highlight OVAPreen and CedenaPhil as our two, either in phase three, as OVAPreen is, or getting phase three ready, as CedenaPhil is. Those have really been our priorities, both operationally, you know, in terms of where we put our bandwidth, but also, obviously, financially as well. And those, you know, those really remain our priority.

Speaker Change: Yeah, another great question. So, as we've, you know, really been trying to highlight Ovapreen and Sidenafil as our two, you know, either in phase three as Ovapreen is or getting phase three ready as Sidenafil is.

Marty: Before I do, I'm going to first turn the call back over to our Chief Accounting Officer Marty to review our second quarter financial results. Thanks, Sabrina, and thanks everyone for joining us today. I would now like to summarize Dari's financial results for the quarter ended June 30, 2024, which I will refer to as the second quarter. As Sabrina mentioned, Dari's business strategy is to assemble an advanced support folio 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.

Speaker Change: Those have really been our priorities, both operationally.

Speaker Change: you know, in terms of where we put our bandwidth, but also, obviously, financially as well. And those, you know, those really remain the priority. However, to your point, we have a very deep pipeline, and particularly with a lot of the noise around menopause lately, we've been getting a lot of questions and interest.

Sabrina Johnson: And those, you know, those really remain the priority. However, to your point, we have a very deep pipeline and, particularly with a lot of the noise around menopause lately. We've been getting a lot of questions and interest broadly around our menopause programs that we have the two that I highlighted today. So, we're also, you know, doing everything we can to make sure that we are advancing those programs as much as possible operationally by being very capital responsible and really focusing our priorities around over pre and into the NFL right now, responsibly with our. Capital.

Sabrina Martusi Johnson: However, to your point, we have a very deep pipeline, in particular with a lot of the noise around menopause lately. We've been getting a lot of questions and interest broadly around our menopause programs that we have, the two that I highlighted today. So, we're also, you know, doing everything we can to make sure that we are advancing those programs as much as possible operationally by being very capital responsible and really focusing our priorities around OVAPreen and CedenaPhil right now responsibly with our capital. Okay, great. Thank you so much. Absolutely not.

Speaker Change: Broadly around our menopause programs that we have, the two that I highlighted today. So we're also, you know, doing everything we can to make sure that we are

Sabrina Johnson: So, we're also, you know, doing everything we can to make sure that we are advancing those programs as much as possible operationally by being very capital responsible and really focusing our priorities around OVAPreen and CedenaPhil right now, responsibly with our capital. Okay, great. Thank you so much.

Speaker Change: Advancing those programs as much as possible operationally by being very capital responsible and really focusing our priorities around over premiums to benefit right now responsibly with our capital.

Marty: The investment required to build an advanced support folio includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development, or R&D expenses. During the second quarter of 2024, our general administrative expenses, or GNA, were approximately 2.4 million, which is a 16 percent decrease compared to Q2 2023, due primarily to reduce head count and reduce professional services expense. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory, and other activities across our entire portfolio, were approximately 4.9 million for the second quarter, which is a 19 percent decrease compared to Q2 2023.

Douglas Tsao: Okay, great. Thank you so much. Absolutely.

Speaker Change: Okay, great. Thank you so much.

Unknown Executive: That concludes our question and answer session.

Operator: That concludes our question and answer session. I would like to turn the call back over to Sabrina Matusi Johnson for any additional or closing remarks.

Operator: That concludes our question and answer session. I would like to turn the call back over to Sabrina Matusi Johnson for any additional or closing remarks.

Speaker Change: Absolutely.

Sabrina Johnson: I would like to turn the call back over to Sabrina Mathewsy Johnson for any additional or closing remarks. Great. Well, thank you all for taking the time this afternoon to hear about our recent updates and our ongoing commitment to drive value for all of our DRA stakeholders by identifying and advancing potential new therapies to provide additional choices, enhanced outcomes, and ease of use for women. As you heard today, we continue to make great progress and are excited for what the rest of this year holds for DRA. As we look ahead to the rest of 2024, we expect several milestones this year, including more of a printable study update to say indicated as we work to complete what we expect to be that single registration study.

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

Sabrina Johnson: Great, well thank you all for taking the time this afternoon to hear about our recent updates and our ongoing commitment to drive value for all of our D.A.R.E. stakeholders by identifying and advancing potential new therapies to provide additional choices, enhanced outcomes, and ease of use for women. As you heard today we continue to make great progress and are excited for what the rest of this year holds for D.A.R.E. As we look ahead to the rest of 2024 we expect several milestones this year including more of a pre-pivotal study updates as I indicated as we work to complete what we expect to be that single registration study and as we've just been talking about updates on our discussions with the FDA and the activities that we're doing to commence that phase three for our potential first and category treatment option for women with sexual arousal disorder to then it's all cream.

Sabrina Martusi Johnson: Well, thank you all for taking the time this afternoon to hear about our recent updates and our ongoing commitment to drive value for all of our DARI stakeholders by identifying and advancing potential new therapies to provide additional choices, enhanced outcomes, and ease of use for women. As you heard today, we continue to make great progress and are excited about what the rest of this year holds for DARE. As we look ahead to the rest of 2024, we expect several milestones this year, including more of the pre and pivotal study updates as I indicated, as we work to complete what we expect to be that single registration study.

Speaker Change: Great. Well, thank you all for taking the time this afternoon to hear about our recent updates and our ongoing commitment to drive value for all of our DARI stakeholders by identifying and advancing potential new therapies to provide additional choices, enhanced outcomes, and ease of use for women.

Sabrina Martusi Johnson: And as we've just been talking about, updates on our discussions with the FDA and the activities that we're doing to commence phase three for our potential first-in-category treatment option for women with sexual arousal disorder, Kadenophil cream. And as we also touched on at the end of the call, our unique model really has a deep pipeline and support from commercial collaborators, and therefore, we believe we're well positioned to accelerate innovation for women everywhere while also driving value for all of Dari's stakeholders. We look forward to keeping you updated on our progress towards the milestones we discussed today. Thank you. This concludes today's call. Thank you all for joining us. You may now disconnect.

Marty: As we guided previously this year, we continue to anticipate our full-year 2024 R&D expenses will be less than our 2023 R&D expenses. Our comprehensive income for the second quarter was approximately 12.9 million driven by proceeds from the royalty monetization transaction we closed in April. We ended the second quarter with approximately 16.4 million in cash and cash equivalent, and had approximately 8.5 million shares of common stock outstanding as of August 9, which reflects the reverse stock split that was implemented on July 1, 2024.

Speaker Change: As you heard today, we continue to make great progress and are excited for what the rest of this year holds for DARE. As we look ahead to the rest of 2024, we expect several milestones this year, including

Speaker Change: More of a pre and pivotal study updates, as I indicated, as we work to complete what we expect to be that single registration study. And as we've just been talking about, updates on our discussions with the FDA and the activities that we're doing to commence that phase three for our potential first in category treatment option for women with sexual arousal disorder. And I'm going to turn it back over to you, Dr. Haring.

Sabrina Johnson: And as we've just been talking about updates on our discussions with the FDA and the activities that we're doing to commence that phase three for our potential first and category treatment option for women with sexual levels disorder to then a fill cream. And as we also touched on at the end of the call, our unique model really also has deep pipeline and support of commercial collaborators, and therefore we believe we're well positioned to accelerate innovations for women everywhere while also driving value for all of DRA stakeholders. We look forward to keeping you updated on our progress towards the milestones we discussed today.

Sabrina Johnson: And as we also touched on at the end of the call, our unique model really has a deep pipeline and support from commercial collaborators, and therefore, we believe we're well positioned to accelerate innovation for women everywhere while also driving value for all of D.A.R.E.'s stakeholders. We look forward to keeping you updated on our progress towards the milestones we discussed today. Thank you.

Marty: In April, we announced and closed a royalty monetization transaction with Zelma, in which DRA received 22 million and gross proceeds, and following a pre-specified total return to Zelma, Zelma will make upside-sharing milestone payments to DRA equal to 50 percent of all remaining cash flows sold to Zelma under the transaction. This monetization of future net royalty and net milestone payments accelerates potential cash flows from the future commercial success of Zalciato, and ensures that DRA and our shareholders have the opportunity to participate meaningfully in Zalciato economics as commercialization progresses.

Dr. Haring: And as we also touched on at the end of the call, our unique model really also has a deep pipeline and support of commercial collaborators, and therefore we believe we're well positioned to accelerate innovation for women everywhere, while also driving value for all of DARI stakeholders.

Speaker Change: We look forward to keeping you updated on our progress towards the milestones we discussed today. Thank you.

Unknown Executive: Thank you. Thank you all for joining.

Operator: This concludes today's call. Thank you all for joining us. You may now disconnect.

Unknown Executive: You may now disconnect.

Speaker Change: Is that today's call? Thank you all for joining. You may now disconnect.

Marty: This non-deludive financing provides DRA with a significant capital to help achieve our objectives and, importantly, allows us to focus on advancing our late-stage potential first-ing category, investigational products, over-cream, and salventful creams, both of which represent large-market opportunities. The structure of this transaction also underscores the significant potential of over-cream and salventful creams with DRA retaining the significant majority of future economics and the ability to achieve attractive margins through retained net sales in all commercial milestones.

Marty: In the second quarter, we also received 1 million as the latest installment under our grant agreement with Foundation in support of our investigational contraceptive, Dare Lark 1. Under the terms of the grant agreement, DRA may receive a total of up to approximately 49 million to support non-clinical development of Dare Lark 1. This funding will allow us to advance the development of Dare Lark 1 through non-clinical proof of principal 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.

Marty: To date, DRA has received approximately 29.3 million under the Dare Lark 1 grant agreement. Together, the royalty financing and latest installment in grant funding represent our commitment to being creative, collaborative, and opportunistic, and seeking capital needed to meet our objectives and to build shareholder value.

Marty: We encourage investors to review the more detailed discussion of our financial, financial condition, liquidity, capital resources, and risk factors in our form 10Q for the quarter ended June 30, 2024, which we filed this afternoon, as well as our annual form 10K for the year ended December 31, 2023, which was filed on March 28, 2024.

Sabrina Johnson: I'd now like to return the call back over to Sabrina.

Sabrina Johnson: Great, thank you, Marty, I'm now going to talk through our 2024 accomplishments to date and to participate in milestones with the focus on our late-stage candidates to the NFL Cream and Ova Cream. But first, I'll provide an update on our on-market asset, Zasciato. So as a reminder, Zasciato, or clindamycin phosphate 2% vaginal gel, is indicated to the treatment of bacterial vaginosis in 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, notice time spent in place.

Sabrina Johnson: In the first quarter of 2024 through our commercialization agreement with Oregonon, Zasciato became available by prescription across the United States. The Organ on Women's Health Sales team continues to see steady month-over-month increases in total prescriptions of Zasciato and new prescriber volumes in line with the opportunity for a new branded entrance in the category. There are positive signals related to strong clinical acceptance among early adopters with multiple uses among trialists paired with a positive patient reception and the team continues to unlock access channels for a frictionist fulfillment experience for both patients and providers.

Sabrina Johnson: I now like to provide an update on Sydenicel Cream, 3.6 percent. So during the second quarter we continued our interactions with the FDA on the development program for Sydenicel Cream as a treatment for female sexual arousal disorder, including with respect to the proposed efficacy endpoints to take forward into phase three development. The patient population and the endpoints we proposed to the FDA for phase three clinical development were those where our post-talk analyses for the phase two these study data showed that Sydenicel Cream demonstrated statistically significant and meaningful patient improvements.

Sabrina Johnson: During the second quarter we provided responsive materials to queries from the FDA regarding patient reported outcomes and the qualitative assessment of within patient clinically meaningful improvement that we saw in the phase two these study based on the participant exit interviews. While the FDA had indicated it anticipated providing additional feedback during the second quarter on the phase three design which would be the first ever phase three pivotal study of a therapeutic candidate for the treatment of arousal disorder and women.

Sabrina Johnson: Its review is ongoing and we've looked forward to providing updates on the FDA's feedback the phase three study design and plans as well as any relevant updates on our collaboration strategy as they become available. And preparation for phase three initiation during the second quarter we completed the big defense meetings with the CROs being considered for the phase three studies and launched the manufacturing campaign to support phase three. In terms of market and revenue potential there are currently no FDA approved treatments for any form of sexual arousal disorder in women.

Sabrina Johnson: Meaning Sydenicel Cream has the potential to be the first. Sydenicel is the active ingredient in tablet form for oil 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 and market research suggests that approximately 20 million women in the US experience symptoms of low or no sexual arousal. In terms of probability of success we've already demonstrated that Sydenicel Cream increased general blood tissue flow in quantitative studies and as we previously shared we've completed all of the study analyses and data from the exploratory phase to the respond clinical trial of Sydenicel Cream and identified the patient population that received the greatest benefit from Sydenicel Cream in their general arousal response.

Sabrina Johnson: The efficacy findings and details regarding this patient population were published in the Journal of Obstetrics and Gynecology which is the official Journal of the American College of Obstetrics and Gynecology or ACOG. And were available open access online in June. And our publication was featured as the featured article in July for In The Green Room, which is the ACOG podcast. Our study was also spotlighted in an editorial in the journal. It's a distinct honor to be featured and we are pleased to see the medical community selling engaged in these first of its kind data, ran such a significant unmet need.

Sabrina Johnson: We look forward to providing additional updates on the development program as they are available.

Sabrina Johnson: In terms of overpring, we also want to provide an update on the advancement of the phase 3 study of overpring, which is our novel investigational hormone-free monthly international contraceptive, whose US commercial rights are under a license agreement with Dare. Non-commono contraception represents a significant commercial market opportunity, as there are no currently no monthly hormone-free contraceptives approved by the FDA. Overpring has potential to be a disruptive product in the contraceptive category, and an important option for women who cannot use hormone-based birth control products, or prefer not to do so, based on market research approximately 35 million women in the US of potential candidates for overpring.

Sabrina Johnson: Working with study collaborators at the UNIS Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, of the National Institutes of Health, or NIH, recommence patient enrollment in the other pre-pivotal phase 3 clinical study in December of 2023. Recruitment is currently underway at 20 sites across the United States, and it's supported by a central advertising campaign for the study that launched in March of this year, March 2024. You can see the campaign materials by visiting our website homepage.

Sabrina Johnson: While there are 20 sites currently recruiting, it's clear that a subset of approximately half of those sites are the most successful in translating into study participants that considerable interest we have seen from women in response to the central advertising campaign. As a result, we have a range of enrollment projections that very considerably based on the enrollment rates at our most successful sites versus those that are not enrolling at a similar pace.

Sabrina Johnson: As a reminder, the study aims to enroll sufficient participants across the study sites to have approximately 250 participants complete approximately 12 months, which is 13 menstrual cycles of product use. Based on the current average enrollment rate across all of the 20 sites, 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 product used by the end of the second quarter in 2025.

Sabrina Johnson: We are, of course, looking at strategies to ensure that all of the study sites are equally successful and productive and look forward to providing updates on enrollment projections and rates as enrollment progresses in the coming quarters.

Sabrina Johnson: Based on communications to date with the FDA, if successful, we believe that just this single registration study will be required to support a pre-market approval application submission with the FDA.

Sabrina Johnson: I now like to turn to dare HRT1 and dare VVA1 because lastly, given the unveiling earlier this year of a bipartisan Senate bill that would authorize 275 million to boost research, training, and public awareness around metaphors and mid-life women's health issues. An area that has often been too stigmatized over looked and underfunded. We've been getting lots of questions about our menopause related programs. Dare HRT1 is a potential first vaginal monthly therapy for the days and motor symptoms of menopause.

Sabrina Johnson: This is a program we are preparing for the single phase three clinical study we believe will be required for approval via the FDA's 505B2 pathway. In addition, dare VVA1 which is our hormone free vaginal candidate for sexual pain due to the vulgar vaginal atrophy or VVA associated with menopause is phase two ready and we're actively exploring opportunities to move this program forward. We're looking forward to seeing continued progress in the menopause phase and potential progress of this new bill and will provide updates on our dare HRT1 and dare VVA1 programs as available.

Sabrina Johnson: In summary, we continue to progress our portfolio of potential first and category product candidates and look forward to providing more updates this year as we work to advance some of the most potentially disruptive candidates for the health and well-being of women in decades, collaborating with leading companies, including Oregon on Frisciado and Bayer for overpring to commercialize and deliver these treatments to as many women as possible.

Unknown Executive: I'd now like to turn the call over to the operator for Q&A. Thank you.

Unknown Executive: We will now begin the question and answer session. At this time, I would like to remind everyone in order to ask a question, press the star and then the number one on your telephone keypad. If you are called to ask your question and are listening by a loudspeaker on your device, please pick up your handset and ensure that your phone is not on with when asking your question. We will post for a moment to confide the question and answer roster.

Catherine Novack: Your first question comes from the line of Catherine Novak of Jones Research. Please go ahead. Hi. Good afternoon. Congrats on all the progress this quarter. I wanted to ask again for overprinting. With the timing updates that you gave today, can you give us a sense of what implications this has for top line readout? And then given that this is single arm, do you have any plans for an interim look so we can see data a little bit sooner?

Catherine Novack: Yeah, absolutely. There's a great question. We don't have timing yet for top line. You know, as I mentioned in the prepared remarks, there's a difference in enrollment rate between some of the sites. And I want to be clear there's not a difference in demand. So the central advertising campaign has been quite successful in terms of generating patient interest in the study quite effectively across the site. It's just a difference in terms of how successful some of the sites are translating those the women into study participants from that considerable interest.

Catherine Novack: And so we feel comfortable at this time, projecting when we'll have right half of the subjects having completed about halfway through right six months of their assessment. We definitely look forward to giving more updates, including an opportunity to do an interim analysis at that point. But we're not prepared yet to give exact timing on on final top line. We really want to get a little further in enrollment and and a little further in, you know, looking at some of these strategies we've been implementing to help all the sites be equally successful. Productive, and pulling those patients that have expressed interest forward.

Sabrina Johnson: Great. And then again, since this is single arm, can you remind us that typical use pearl index that you that would make this, you know, commercially compelling asset? Yeah, it's a great question. So the non hormonal category for crunch, so for first of all, I should take a step back. So pearl index is how contraceptive methods are evaluated by the FDA, and it's the metrics that use regardless of whether it's a hormonal product or a non hormonal product.

Sabrina Johnson: And FDA approved products have a very wide range of pearl indices. So most effective is one that's like an intrauterine device, right, which is implanted. And the least effective of the FDA approved methods are the thermocides of vaginal gels, which have a pearl index in the 27 to 28 range. So it's a very broad range. And in the non hormonal category, there really are not that many options and the options that are available other than the upper IUD, which is in that one range.

Sabrina Johnson: The other options are at the other end of the spectrum closer to the 27 to 28 or are the 27 to 28 range. So as we think about a product like overpring, it would be the first product to be a once a month. So all the other non hormonal products that are in the upper IUD are pericoidal, meaning they're used in the method, think condoms, think from the side. So it would be different in that regard.

Sabrina Johnson: And based on the pre-pivotal study data that's been generated, that study suggests that the surrogate marker that's used for that study and contraceptive effectiveness, that it has the potential to be in the same range. As the hormonal methods, the short acting hormonal methods like pills, patches, rings. But the bar is fairly low right for the non hormonal methods given what some of the other approved products are. And that really means from an acceptability perspective, there's really a wide range of efficacy that could be very acceptable for methods like overpring, given that it also has convenience.

Sabrina Johnson: But none of the other non hormonal methods have. So the pre-pivotal data suggests that it has that opportunity for effectiveness in the same range as the short acting hormonal methods. And then to your question Catherine, the range in general, though, for non hormonal methods is actually quite wide, which really speaks to you in the end. And you know, it's all about contraceptive methods that women will use. And that's why the FDA has approved such a wide range of contraceptive effectiveness.

Sabrina Johnson: So there's a wide range, therefore, of acceptability and commercial viability for products like overpring, particularly given that it would be the only once a month method that's available, right. Non pericordal method or non implanted method that would be available in the hormonal free category.

Catherine Novack: This is great. That's helpful. Thank you. Looking forward to getting more updates from the program down the line. Absolutely. Thank you. Again, if you would like to ask a question, press the star and then the number one on your telephone keypad.

Douglas Tsao: Here next question comes from the line up Douglas Tsao of HC, Wayne Wright and Cole, please go ahead. Hi, good afternoon. Nice to have you. Thank you for taking the questions. I guess Sabrina, in terms of your interactions with the FDA for this event also, a cream program. I guess I'm just curious, are you anticipating another meeting being needed to sort of get this final alignment or do you think your sort of interactions are sufficient to get this settled?

Douglas Tsao: Yeah, that's a great question. You know, it's definitely clear that, which we know, right, this is a first and category indication and a first and category product. And there's a lot of data for the FDA to go through. And there's also a lot of kind of key opinion leader support that we have provided to the FDA historically, right in terms of understanding of the indication, understanding of the outcome measures. So, you know, there may be questions or circumstances where that's helpful, not clear at this time.

Douglas Tsao: Right now, the questions have really been straightforward in terms of, you know, kind of the typical things where we're providing a lot of, as I said, information around those outcome measures and what's the clinically meaningful improvement and there's a whole very specialized assessment in the patient reported outcome world called the psychometric. Analysis and assessment that was done, so a lot of the information we're providing is really providing that color. But to be determined, you know, we'll definitely be open to that.

Douglas Tsao: We today have had a number of meetings with the FDA and when we've had them in the past, they've definitely been super productive, so we're definitely open to that. But at this point, you know, nothing definitive in that front. Okay, and just, you know, you obviously have a very rich pipeline with a lot of opportunities. I guess how are you thinking about sort of prioritizing things in the context of your balance sheet and, you know, what you can afford to do right now?

Douglas Tsao: Yeah, another great question. And so, as we've, you know, really been trying to highlight over pre and into the NFL as are two, you know, either in phase three, as the pre and is or getting phase three ready as the NFL is those have really been our priorities, both operationally, you know, in terms of where we put our bandwidth, but also obviously financially as well. And those, you know, those really remain the priority.

Douglas Tsao: However, to your point, we have a very deep pipeline and particular with a lot of the noise around menopause lately. We've been getting a lot of questions and interest broadly around our menopause programs that we have the two that I highlighted today. So, we're also, you know, doing everything we can to make sure that we are advancing those programs as much as possible operationally by being very capital responsible and really focusing our priorities around over pre and into the NFL right now, responsibly with our. Capital. Okay, great. Thank you so much. Absolutely.

Unknown Executive: That concludes our question and answer session.

Sabrina Johnson: I would like to turn the call back over to Sabrina Mathewsy Johnson for any additional or closing remarks. Great. Well, thank you all for taking the time this afternoon to hear about our recent updates and our ongoing commitment to drive value for all of our DRA stakeholders by identifying and advancing potential new therapies to provide additional choices, enhanced outcomes, and ease of use for women. As you heard today, we continue to make great progress and are excited for what the rest of this year holds for DRA.

Sabrina Johnson: As we look ahead to the rest of 2024, we expect several milestones this year, including more of a printable study update to say indicated as we work to complete what we expect to be that single registration study. And as we've just been talking about updates on our discussions with the FDA and the activities that we're doing to commence that phase three for our potential first and category treatment option for women with sexual levels disorder to then a fill cream.

Sabrina Johnson: And as we also touched on on the end at the end of the call, our unique model really also has deep pipeline and support of commercial collaborators and therefore we believe we're well positioned to accelerate innovations for women everywhere while also driving value for all of DRA stakeholders. We look forward to keeping you updated on our progress towards the milestones we discussed today.

Unknown Executive: Thank you. Thank you all for joining. You may now disconnect.