Dare Bioscience Inc (DARE) 2025 Q1 法說會逐字稿

Welcome to the conference call hosted by Dare Bioscience to review the company's first quarter 2025 financial results and to provide a business update. This call is being recorded. My name is Gail, and I will be your operator today. With us today from Dare are Sabrina Martucci Johnson, President and Chief Executive Officer; and MarDee Haring-Layton, Chief Accounting Officer. Ms.

歡迎參加 Dare Bioscience 主辦的電話會議，回顧該公司 2025 年第一季的財務表現並提供業務更新。此通話正在錄音。我叫蓋爾，今天我將擔任您的接線生。今天與我們一起出席 Dare 活動的有總裁兼首席執行官 Sabrina Martucci Johnson 和首席會計官 MarDee Haring-Layton。多發性硬化症。

Haring-Layton, please proceed.

哈林-萊頓，請繼續。

Good afternoon, and welcome to the Dare Bioscience Financial Results and Business Update Call for the quarter ended March 31, 2025. Today, we will review our results, discuss developments and expectations for our pipeline and portfolio and discuss our recently announced expanded business strategy, leveraging a dual path strategy where we commercialize our proprietary formulations via 503B compounding while continuing to seek FDA approval as well as taking steps toward launching certain solutions as branded consumer health products that do not require a prescription, in all cases, to bring solutions to market as soon as practicable. I would like to remind you that today's discussion will include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements 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.

下午好，歡迎參加 Dare Bioscience 2025 年 3 月 31 日止季度財務業績和業務更新電話會議。今天，我們將回顧我們的業績，討論我們的產品線和產品組合的發展和預期，並討論我們最近宣布的擴大業務戰略，利用雙路徑戰略，通過 503B 複合將我們的專有配方商業化，同時繼續尋求 FDA 批准，並採取措施推出某些解決方案作為不需要處方的品牌消費者保健產品，在所有情況下，盡快將解決方案推向市場。我想提醒您，今天的討論將包括聯邦證券法所定義的前瞻性陳述，這些陳述是根據 1995 年《私人證券訴訟改革法案》的安全港條款作出的。本次電話會議中所做的任何非歷史事實陳述均應被視為前瞻性陳述。由於已知和未知的風險和不確定性，實際結果或事件可能與這些陳述預期或暗示的結果或事件有重大差異。

You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended March 31, 2025, which was filed today and our Form 10-K for the year ended December 31, 2024. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, May 13, 2025. 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.

您不應過度依賴前瞻性陳述。前瞻性陳述完全符合公司向美國證券交易委員會 (SEC) 提交的文件中警示性聲明的規定，包括我們今天提交的截至 2025 年 3 月 31 日的季度 10-Q 表和截至 2024 年 12 月 31 日的年度 10-K 表。我還想指出，本次通話的內容包含一些時效性訊息，這些訊息截至今天（2025 年 5 月 13 日）為止都是最新的。除非法律要求，否則 Dare 不承擔更新任何前瞻性聲明以反映本次電話會議後的新資訊或發展的責任。現在我將把發言權交給薩布麗娜。

Thank you, and thank you, everyone, for joining the call today. We are excited to announce today that in addition to our proprietary Sildenafil cream formulation, we are taking action to make 3 more solutions for women available commercially, 2 vaginal probiotics in 2025 and our proprietary monthly hormone therapy in 2026. Making our hormone therapy solution available next year creates a commercial opportunity for Dare in the estimated up to $4.5 billion compounded hormone therapy market and enables women to have access to an evidence-based solution. As you can appreciate, 4 on-market products will accelerate revenue generation and provide a path to profitability. We expect to start recording revenue in the fourth quarter of this year.

謝謝大家，也謝謝大家今天參加電話會議。今天，我們很高興地宣布，除了我們專有的西地那非乳膏配方外，我們還將採取行動，將另外 3 種女性解決方案推向市場，即 2025 年推出的 2 種陰道益生菌和 2026 年推出的我們專有的每月激素療法。我們的荷爾蒙治療解決方案將於明年上市，這將為 Dare 在價值高達 45 億美元的複合激素治療市場中創造商業機會，並使女性能夠獲得基於證據的解決方案。正如您所了解的，4 款上市產品將加速創造收入並提供獲利途徑。我們預計將於今年第四季開始記錄收入。

Anyone following the health care and biotech sectors knows that the first quarter of 2025 has been marked by distractions and disruptions for the overall health care and biotech sector. I'm proud that Dare is uniquely positioned to cut through the noise and deliver value to all of our shareholders, women, health care providers and investors who are all stakeholders in Dare. Today, biopharmaceutical companies with relatively low-risk assets, a competitive advantage and a path toward near-term revenue are positioned to offer upside. We believe that is Dare today. Women's health is ripe for returns because it has been underfunded and fragmented.

關注醫療保健和生物技術領域的人都知道，2025 年第一季度，整個醫療保健和生物技術領域都充滿了乾擾和混亂。我很自豪 Dare 擁有獨特的優勢，能夠消除乾擾，為所有股東、女性、醫療保健提供者和投資者（他們都是 Dare 的利益相關者）創造價值。如今，擁有相對低風險資產、競爭優勢和短期獲利途徑的生物製藥公司有望獲得上行空間。我們相信這就是今天的敢於挑戰。由於婦女健康領域資金不足且分散，因此亟待回報。

And with our recently announced expanded business strategy, we believe we are strongly positioned to deliver value and returns to all of our stakeholders with a business model that is nimble, allowing us to rapidly commercialize multiple products via multiple channels. We're no longer only seeking FDA approval. We're leveraging a dual path strategy where we commercialize via 503B compounding while continuing to seek FDA approval. We're also taking steps towards launching certain solutions as branded consumer health products that do not require a prescription. At Dare, women's health isn't just a priority.

透過我們最近宣布的擴大業務策略，我們相信，我們有能力透過靈活的業務模式為所有利害關係人創造價值和回報，使我們能夠透過多種管道快速將多種產品商業化。我們不再僅僅尋求 FDA 的批准。我們正在利用雙路徑策略，透過 503B 複合進行商業化，同時繼續尋求 FDA 批准。我們也正在採取措施，推出某些無需處方的品牌消費者保健產品。在 Dare，女性健康不僅僅是首要考慮的問題。

It's our sole purpose. And to our knowledge, we are the only publicly traded company focused solely on developing therapeutic products for a broad range of conditions affecting women, contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. And to our knowledge, we are the only publicly traded company leveraging all available paths to bring evidence-based solutions to market, reflecting where and how women are getting and paying for their care. as an FDA-approved treatment, as a compounded product, as a consumer health product that does not require a prescription available via telehealth, online or via an in-person visit with her health care provider. Our portfolio is compelling.

這是我們唯一的目的。據我們所知，我們是唯一一家專注於開發治療女性多種疾病的治療產品的上市公司，涉及避孕、性健康、骨盆疼痛、生育能力、傳染病、陰道健康和更年期等。據我們所知，我們是唯一一家利用所有可用途徑將循證解決方案推向市場的上市公司，反映了女性在哪裡以及如何獲得和支付她們的護理費用。作為 FDA 批准的治療方法，作為複合產品，作為不需要處方的消費者保健產品，可透過遠距醫療、線上或親自訪問她的醫療保健提供者獲得。我們的產品組合非常引人注目。

And over the last months and the next months, we look forward to continuing to provide updates regarding strategic partnerships and collaborations to facilitate access to Dare on market brands for women across multiple channels. Today, I'll provide some perspective on these channels and the strategic relationships we're seeking to enter into to provide women with access to our evidence-based solutions from their trusted sources, where they get their medication and their health care solutions. I'll also provide a refresher on our potential first-in-category monthly intravaginal hormone therapy, a product candidate we've been developing to really shift the hormone therapy landscape. Gaps in solutions for menopause symptoms have given rise to an explosion of untested supplements and therapies. We believe in delivering hormone therapy that has been rigorously studied to meet the needs of women and their doctors.

在過去的幾個月和接下來的幾個月裡，我們期待繼續提供有關策略合作夥伴關係和合作的最新訊息，以方便女性透過多種管道接觸 Dare 市場品牌。今天，我將就這些管道和我們正在尋求建立的策略關係提供一些看法，以便女性能夠從她們可信賴的來源獲得我們基於證據的解決方案，從她們那裡獲得藥物和醫療保健解決方案。我還將重新介紹我們潛在的首創月度陰道內荷爾蒙療法，這是我們一直在開發的候選產品，旨在真正改變荷爾蒙療法的格局。更年期症狀解決方案方面的差距導致未經檢驗的補充劑和療法大量湧現。我們相信，經過嚴格研究的荷爾蒙療法能夠滿足女性及其醫生的需求。

Please keep in mind that bringing our proprietary Sildenafil cream formulation and our monthly intravaginal hormone therapy solution to market via 503B compounding will not impact the regulatory process or commercial opportunity for an FDA-approved product. Rather, if successful, it accelerates the availability of these proprietary formulations for health care providers and women and it accelerates revenue. It can also provide real-world evidence and experience that we would seek to utilize to streamline the path to an FDA approval of these potential first-in-category candidates. I'll also give some background on the vaginal probiotics that we also intend to bring to market this year. Both of which, by the way, were identified via a grant we received from the Gates Foundation to evaluate the global probiotic manufacturer community and identify evidence-based formulations from manufacturers following GMP.

請記住，透過 503B 複合將我們專有的西地那非乳膏配方和每月陰道內荷爾蒙治療解決方案推向市場不會影響 FDA 批准產品的監管流程或商業機會。相反，如果成功的話，它將加速這些專有配方對醫療保健提供者和女性的普及，並增加收入。它還可以提供現實世界的證據和經驗，我們將利用這些證據和經驗來簡化 FDA 批准這些潛在的同類首創候選藥物的途徑。我也會介紹一些我們打算今年推向市場的陰道益生菌的背景資訊。順便說一下，這兩個都是透過我們從蓋茲基金會獲得的資助確定的，目的是評估全球益生菌製造商社區，並確定遵循 GMP 的製造商的循證配方。

I'll also give a brief update on Ovaprene, our novel investigational hormone-free monthly intravaginal contraceptive, the ongoing enrollment in the pivotal Phase III contraceptive efficacy study and our Data Safety Monitoring Board interim assessment, which is scheduled for July of this year as well as other therapeutic development pipeline updates on Sildenafil and Dare -HPV, which is our investigational product for the treatment of human papillomavirus infection, which is the virus that causes cervical cancer. Before I provide additional updates, I'm going to first turn it back over to our Chief Accounting Officer, Mardee, to review first quarter 2025 financial results.

我還將簡要介紹我們的新型研究性無激素月度陰道內避孕藥 Ovaprene、正在進行的關鍵性 III 期避孕效果研究的招募情況和我們計劃於今年 7 月進行的資料安全監測委員會中期評估，以及有關西地那非和 Dare -HPV 的其他治療開發管道更新，Dare -HPV 是我們用於治療人類乳頭瘤病毒感染（一種導致子宮頸癌病毒的研究產品。在我提供更多更新之前，我將首先將其交還給我們的首席會計官 Mardee，以審查 2025 年第一季的財務業績。

Thanks, Sabrina, and thanks, everyone, for joining us today. I would now like to summarize Dare's financial results for the quarter ended March 31, 2025, which I will refer to as the first quarter. Put simply, Dare's business strategy is to assemble and advance a portfolio of differentiated treatment solutions that address meaningful unmet needs we've identified in women's health and then to monetize the value of our portfolio of clinical and regulatory advances over the near and long term. The investment required to build and advance a portfolio includes corporate overhead, portfolio acquisition and maintenance costs and ongoing research and development or R&D expenses. During the first quarter of 2025, our general and administrative expenses were approximately $2.3 million, which is a 14% decrease compared to Q1 2024 due primarily to reduced stock-based compensation expense, reduced professional services expense and reduced headcount.

謝謝薩布麗娜，也謝謝大家今天的到來。現在，我想總結一下 Dare 截至 2025 年 3 月 31 日的季度財務業績，我將其稱為第一季。簡而言之，Dare 的業務策略是組建和推進一系列差異化治療解決方案，以滿足我們在女性健康領域發現的未滿足的重要需求，然後在短期和長期內將我們的臨床和監管進步組合的價值貨幣化。建立和推進投資組合所需的投資包括公司管理費用、投資組合收購和維護成本以及持續的研究和開發或研發費用。2025 年第一季度，我們的一般和行政費用約為 230 萬美元，與 2024 年第一季度相比下降了 14%，這主要是由於股票薪酬費用減少、專業服務費用減少和員工人數減少。

We continue to maintain a lean and focused team and are managing overhead costs closely. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory and other development program costs were approximately $2.3 million, which is a 31% decrease compared to Q1 2024. Our comprehensive loss for the quarter was approximately $4.4 million. We ended the first quarter with approximately $10.3 million in cash and cash equivalents and a working capital deficit of approximately $9.4 million. Dare remains committed to being creative, collaborative and opportunistic to build shareholder value, including by making certain proprietary formulations in the DA portfolio accessible via a prescription through the FDA's 503(b) pathway.

我們繼續保持精簡而專注的團隊，並密切管理管理費用。我們的研發費用根據臨床、臨床前、製造、監管和其他開發計劃成本而有所不同，約為 230 萬美元，與 2024 年第一季相比下降了 31%。本季我們的綜合虧損約為 440 萬美元。第一季結束時，我們的現金和現金等價物約為 1,030 萬美元，營運資金赤字約為 940 萬美元。Dare 始終致力於透過創新、協作和抓住機會來創造股東價值，包括透過 FDA 的 503(b) 途徑使 DA 產品組合中的某些專有配方可透過處方取得。

As of May 12, 2025, we had approximately 8.9 million shares of common stock outstanding. 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 March 31, 2025, filed today. I would now like to turn the call back over to Sabrina.

截至 2025 年 5 月 12 日，我們已發行約 890 萬股普通股。我們鼓勵投資者查看我們今天提交的截至 2025 年 3 月 31 日的季度 10-Q 表中有關我們財務狀況、流動性、資本資源和風險因素的更詳細討論。現在我想把電話轉回薩布麗娜。

Thank you. So as we all know, and we've been discussing, we are a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority. Our vision is to meet the increasing demand for evidence-based treatments with both uncompromising scientific rigor and rapid responsible commercialization. As a leader in women's health, we continuously hear from the health care providers and women themselves about the urgent need for faster access to trusted evidence-based treatments that women can afford. We believe that innovation does not have to start from scratch.

謝謝。眾所周知，我們一直在討論，我們是一家生物製藥公司，我們的使命是挑戰現狀，將女性健康放在首位。我們的願景是透過毫不妥協的科學嚴謹性和快速負責任的商業化來滿足日益增長的實證治療需求。作為女性健康領域的領導者，我們不斷聽到醫療保健提供者和女性自己的聲音，她們迫切需要更快地獲得女性能夠負擔得起的可信賴的循證治療。我們相信創新不一定要從零開始。

Solutions that can address decades of unmet needs in women's health often already have clinical proof of concept or existing safety data for the active ingredient. We seek to leverage these data and insights in order to bring solutions to market rapidly in a fiscally responsible manner and in ways designed to optimize access for women. With growing awareness around menopause, sexual health and vaginal health, the conversation is shifting, but access to real evidence-based solutions still lags behind. As awareness grows, so does the demand for treatment options, and we are seeking to meet this moment by ensuring women have access to solutions that are not only needed but are evidence-based. Like our Sildenafil cream formulation, our investigational hormone therapy, DARE-HRT1 is being developed in response to feedback from women and their health care providers.

能夠解決數十年來女性健康領域未滿足需求的解決方案通常已經具有臨床概念驗證或活性成分的現有安全數據。我們力求利用這些數據和見解，以財政負責的方式和旨在優化女性獲取途徑的方式快速將解決方案推向市場。隨著人們對更年期、性健康和陰道健康的認識不斷提高，討論的話題也在發生變化，但獲得真正的基於證據的解決方案的機會仍然落後。隨著人們認識的提高，對治療方案的需求也在增長，我們正在努力滿足這一需求，確保女性能夠獲得不僅是需要的而且有證據支持的解決方案。與我們的西地那非乳膏配方一樣，我們的研究性荷爾蒙療法 DARE-HRT1 也是根據女性及其醫療保健提供者的回饋而開發的。

Specifically, despite the fact that the Menopause Society recommends hormone therapy and recommends delivering estrogen and progesterone together for women with intact uterine and despite the fact that the Menopause Society states that nonoral routes of administration may offer potential advantages, there is no non-oral hormone therapy that meets those criteria that a woman can administer directly. DARE-HRT1 is just that. It's an intravaginal ring that a woman can self-administer just once a month. And like our Sidenail cream formulation, their HRT1 has been evaluated in rigorous toxicology studies and completed pharmacokinetic studies demonstrating the systemic levels of the hormones being administered as measured in the blood of postmenopausal women, our clinical study findings specific to this proprietary formulation have been published in peer-reviewed journals. Making our hormone therapy solution available next year via 503B compounding creates a commercial opportunity for Dare, as I mentioned, in the estimated up to $4.5 billion compounded hormone therapy market and enables women to access this evidence-based solution.

具體來說，儘管更年期協會建議激素療法，並建議對子宮完整的女性同時注射雌激素和孕激素，儘管更年期協會指出非口服給藥途徑可能具有潛在優勢，但目前還沒有任何非口服激素療法能夠滿足女性可以直接使用的標準。DARE-HRT1 就是這樣的。這是一種陰道環，女性每月只需自行使用一次。與我們的 Sidenail 霜配方一樣，他們的 HRT1 已經過嚴格的毒理學研究評估，並且已完成藥物動力學研究，證明了在停經後婦女血液中測量到的所施用激素的系統水平，我們針對該專有配方的臨床研究結果已發表在同行評審期刊上。正如我所提到的，明年透過 503B 複合療法推出我們的荷爾蒙治療解決方案將為 Dare 在價值高達 45 億美元的複合激素治療市場中創造商業機會，並使女性能夠獲得這種基於證據的解決方案。

And as with the menopause sector, gaps in solution in the vaginal health sector have similarly led to an explosion of untested supplements and therapies. The 2 vaginal probiotics that we also intend to bring to market this year, as I noted upfront, were identified via a grant we received from the Gates Foundation last year. It was a grant to evaluate the global probiotic manufacturer community and to identify evidence-based solutions and formulations for manufacturers following GMP. These 2 products were designed to restore a healthy vaginal microbiome and have been evaluated and demonstrated effective in clinical studies in women outside of the United States in restoring a healthy vaginal microbiome, but they are not yet available here. And we want women in the U.S.

與更年期領域一樣，陰道健康領域的解決方案的差距同樣導致了未經測試的補充劑和療法的激增。正如我之前提到的，我們還計劃在今年向市場推出兩種陰道益生菌，它們是透過去年我們從蓋茲基金會獲得的資助而確定的。這是一項資助，旨在評估全球益生菌製造商社區，並為遵循 GMP 的製造商確定基於證據的解決方案和配方。這兩種產品旨在恢復健康的陰道微生物群，並已在美國以外的女性臨床研究中得到評估並證明可有效恢復健康的陰道微生物群，但目前尚未在美國上市。我們希望美國有女性。

to also have access to these evidence-based vaginal probiotics, and we intend to make them available as branded consumer health products later this year. So this is a good place for me to address the strategic partnerships and collaborations we intend to establish to facilitate access to Dare's on-market brands for women across multiple channels for both the prescription products via 503B compounding and branded consumer health products. As I stated at the beginning of the call, our goal is to bring evidence-based solutions to market, reflecting where and how women are getting and paying for their care. As I mentioned, that might be an FDA-approved treatment, a compounded product, a consumer health product that does not require a prescription, might be available via telehealth, other online platforms via an in-person visit with their health care provider. We want women to access these products, these Dare on-market brands from the source they trust and that reflects where and how they are currently selecting their solutions and getting their care today.

也可以獲得這些基於證據的陰道益生菌，我們打算在今年稍後將它們作為品牌消費者保健產品推出。因此，這對我來說是一個很好的機會來談論我們打算建立的策略夥伴關係和合作關係，以促進女性透過多種管道獲得 Dare 的市場品牌，包括透過 503B 複合獲得的處方產品和品牌消費者保健產品。正如我在電話會議開始時所說，我們的目標是將基於證據的解決方案推向市場，反映女性在哪裡以及如何獲得和支付護理費用。正如我所提到的，這可能是一種經 FDA 批准的治療方法、一種複合產品、一種不需要處方的消費者保健產品，可以透過遠距醫療或其他線上平台透過與醫療保健提供者進行面對面訪問來獲得。我們希望女性能夠從她們信任的來源獲得這些產品、這些 Dare 市場品牌，並且這反映了她們目前在哪裡以及如何選擇解決方案並獲得護理。

So what does that mean in terms of our partnering strategy? It means partnering with telehealth providers that reflect Dare's mission of challenging the status quo and putting women's health first and that are committed to providing evidence-based solutions. It means partnering with online retailers that provide complementary offerings. It means collaborating with online prescription fulfillers so that our formulations are available on their platforms. And it means participating in medical conferences and continuing medical education programs so that the health care community is broadly aware of these evidence-based solutions as they consider their treatment guidelines.

那麼這對我們的合作策略來說意味著什麼呢？這意味著與遠距醫療提供者合作，體現 Dare 挑戰現狀、將女性健康放在首位的使命，並致力於提供基於證據的解決方案。這意味著與提供互補產品的線上零售商合作。這意味著與線上處方執行者合作，以便我們的配方可以在他們的平台上使用。這意味著參加醫學會議和繼續醫學教育計劃，以便醫療保健界在考慮治療指南時廣泛了解這些基於證據的解決方案。

Put simply, it means meeting women where they are, wherever they are. Therefore, don't expect just one strategic partnership, expect several. The delivery of health care and the purchase of health care solutions has changed dramatically over the last 5 years, and we would not be true to our corporate tagline, which is daring to be different if we did not lean into the latest trends in accessible health care and put partnerships and collaboration in place that reflect those trends. Finally, I should also note that like our Sildenafil cream and our monthly intravaginal hormone therapy formulations, there are other proprietary formulations in the DAA portfolio that we can make accessible via prescription through the 503(b) pathway. We are actively evaluating the dual path approach for some of our other proprietary formulations -- so that dual path again is to continue to pursue FDA approval of a product candidate for a treatment indication while simultaneously bringing that formulation to market via the 503(b) pathway as soon as practicable.

簡而言之，這意味著無論女性身在何處，都能與她們相遇。因此，不要只期待一個戰略夥伴關係，而要期待多個。過去五年來，醫療保健的提供方式和醫療保健解決方案的購買方式發生了巨大變化，如果我們不順應無障礙醫療保健的最新趨勢並建立反映這些趨勢的伙伴關係和合作關係，我們就無法真正實踐我們“敢於與眾不同”的企業口號。最後，我還應該指出，就像我們的西地那非乳膏和每月一次的陰道內荷爾蒙治療配方一樣，DAA 產品組合中還有其他專有配方，我們可以透過 503(b) 途徑透過處方提供。我們正在積極評估我們其他一些專有配方的雙路徑方法——因此，雙路徑再次是繼續尋求 FDA 對治療適應症候選產品的批准，同時盡快通過 503(b) 途徑將該配方推向市場。

We're taking this approach as part of our responsibility to women, to the health care community and to our shareholders and because we believe women should not have to wait for needed medical treatment solutions while they continue to pursue an FDA-approved path. Over the next months, we'll continue to provide additional updates, so please stay tuned. I'm now going to talk through our anticipated 2025 milestones for our therapeutic product candidates. I'll highlight Ovaprene, Sildenafil cream and DR-HPV in that regard. Ovaprene, again, is our novel investigational hormone-free monthly intravaginal contraceptive, whose commercial rights are under a license agreement with Bayer Healthcare.

我們採取這種方法是出於對女性、醫療保健界和股東的責任，因為我們相信女性不應該一邊等待所需的醫療治療方案，一邊繼續尋求 FDA 批准的治療途徑。在接下來的幾個月裡，我們將繼續提供更多更新，請繼續關注。我現在將討論我們治療產品候選產品預計在 2025 年實現的里程碑。在這方面，我將重點放在 Ovaprene、西地那非乳膏和 DR-HPV。再次強調，Ovaprene 是我們新型的、正在研究的無激素月度陰道避孕藥，其商業權利屬於與拜耳醫療集團簽訂的許可協議。

Enrollment is ongoing in the pivotal Phase III contraceptive efficacy study of vovaprenren. Recall that we announced an up to $10.7 million foundation nondilutive grant in November 2024, which supported the addition of 5 new investigator sites in the first quarter of this year. We've been really pleased with the pace of enrollment at those sites to date. But I will say, don't ask me because it's too early for me to predict enrollment rate for the remainder of the study. I will share, though, that we do not anticipate that the NICHD, those NIH contracted study sites will resume enrolling new participants under their existing NIH contracts.

Vovaprenren 的關鍵 III 期避孕效果研究的招募工作正在進行中。回想一下，我們在 2024 年 11 月宣布了一項高達 1,070 萬美元的基金會非稀釋性撥款，用於支持今年第一季增加 5 個新的研究站點。到目前為止，我們對這些站點的招生速度感到非常滿意。但我會說，不要問我，因為現在預測剩餘研究的入學率還為時過早。不過，我要說的是，我們預計 NICHD 和 NIH 簽約的研究機構不會根據現有的 NIH 合約恢復招募新參與者。

Review of the interim data by the study Safety Data Monitoring Board, which is an independent group of experts, which evaluates the safety and integrity of the study is scheduled for this July, July 2025, and we will provide an update following that meeting. Recall overall that the primary objective of the study is to assess the typical use pregnancy rate over 13 menstrual cycles or the estimated pearl index for Ovaprene. Secondary objectives are to assess Ovaprene's 13-cycle use cumulative pregnancy rate, safety, acceptability, product fit and ease of use and assessments of vaginal health. If successful, we expect the study to support the submission of a premarket approval application for Ovaprene to the FDA as well as regulatory filings in Europe and other countries worldwide to allow marketing approvals of Ovaprene. Regarding sildenafil as an investigational cream formulation of Sildenafil, which is the active ingredient in the oral erectile dysfunction drug for men for topical on-demand administration to treat female sexual arousal disorder, we have continued our interactions with the FDA regarding the planned Phase III study and expect more updates on Phase III design, development and collaboration strategy throughout 2025.

研究安全資料監測委員會（獨立的專家小組）計劃於今年 7 月（即 2025 年 7 月）對中期資料進行審查，以評估研究的安全性和完整性，我們將在會議結束後提供最新資訊。整體回想一下，研究的主要目的是評估 13 月經週期內的典型使用懷孕率或 Ovaprene 的估計珍珠指數。次要目標是評估 Ovaprene 的 13 個週期使用累積懷孕率、安全性、可接受性、產品適合性和易用性以及陰道健康評估。如果成功，我們預計該研究將支持向 FDA 提交 Ovaprene 的上市前批准申請以及在歐洲和世界其他國家提交監管文件，以獲得 Ovaprene 的營銷批准。關於西地那非，作為西地那非的一種研究性乳膏劑型，它是男性口服勃起功能障礙藥物中的活性成分，用於局部按需給藥以治療女性性喚起障礙，我們繼續與 FDA 就計劃中的 III 期研究進行互動，並期望在 2025 年全年獲得有關 III 期設計、開發和合作戰略的更多更新。

We're targeting submission of additional information requested by the FDA, along with the protocol and the statistical analysis plan for the Phase III study to get those to the FDA by the end of the second quarter of 2025. That's really immediately -- our immediate next step on this development program on our path to pursuing an FDA approval. For Dare-HPV, I will remind that in 2024, we were selected to receive an award of up to $10 million for the development of Dare-HPV, which is an innovative investigational treatment for HPV-related cervical diseases. And with the support of that funding, we're advancing DR-HPV towards a Phase II clinical study, which is supported with that funding. Essentially, all cervical cancer cases worldwide are caused by HPV infection.

我們的目標是提交 FDA 要求的補充資訊以及 III 期研究的方案和統計分析計劃，並在 2025 年第二季末之前將這些資訊提交給 FDA。這確實是我們立即採取的下一步行動——在尋求 FDA 批准的道路上，我們在這個開發計劃上採取了這項行動。對於 Dare-HPV，我要提醒的是，2024 年，我們被選中獲得高達 1000 萬美元的獎勵，用於開發 Dare-HPV，這是一種針對 HPV 相關子宮頸疾病的創新研究治療方法。在該資金的支持下，我們正在推進 DR-HPV 的 II 期臨床研究，該研究也得到了該資金的支持。本質上，全球所有子宮頸癌病例都是由HPV感染引起的。

And despite the fantastic advancement in HPV screening and vaccination in the U.S., an estimated 100,000 women are still treated for cervical precancer each year and an estimated 4,000 women are expected to die from cervical cancer in 2024. Today, cervical precancers are monitored until they reach a late stage since the most common treatment is surgery, which removes parts of the cervix. And that surgery is associated with an increased risk of preterm birth and sexual dysfunction. So it's not recommended for patients with fertility concerns. In the U.S., about 10% of women with HPV infection on the cervix will develop long-lasting HPV infections that put them at risk for cervical cancer.

儘管美國在 HPV 篩檢和疫苗接種方面取得了巨大進步，但據估計每年仍有 10 萬名女性接受子宮頸癌前病變治療，預計 2024 年將有 4,000 名女性死於子宮頸癌。如今，子宮頸癌前病變會一直受到監測，直到晚期，因為最常見的治療方法是手術，也就是切除部分子宮頸。而且手術會增加早產和性功能障礙的風險。因此不建議有生育問題的患者使用。在美國，大約 10% 的子宮頸感染 HPV 的女性會發展為長期 HPV 感染，使她們面臨子宮頸癌的風險。

Dare-HPV has the potential to be the first FDA-approved pharmaceutical intervention that could treat both genital HPV infections in women as well as late-stage cervical dysplasia and treat that infection, which would change the paradigm around how HPV-related cervical diseases are clinically managed today, preventing surgery, stopping the spread and transforming care for this critical health issue. And DARE-HPV is reflective of the type of development program we really like to advance at Dare. It's a first-in-category product, but it leverages active pharmaceutical ingredients that have been approved to treat other viral infections. Specifically, Dare-HPV is an investigational proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert with the potential to be this first-in-category treatment for HPV infection and HPV-related cervical diseases. We look forward to continuing to expect activities necessary to enable submission of the IND application to the FDA and for a Phase II randomized placebo-controlled double-blind clinical study of DIRE-HPV for clearance of high-risk HPV infection in women, all supported with the funding we received under that $10 million award.

Dare-HPV 有可能成為第一個獲得 FDA 批准的藥物幹預措施，既可以治療女性生殖器 HPV 感染，又可以治療晚期子宮頸發育不良，這將改變目前臨床治療 HPV 相關子宮頸疾病的模式，防止手術，阻止傳播，並轉變對這一關鍵健康問題的護理。DARE-HPV 體現了我們在 Dare 真正希望推進的開發計劃類型。它是同類產品中的首創產品，但它利用了已獲準用於治療其他病毒感染的活性藥物成分。具體來說，Dare-HPV 是一種研究性的專有固定劑量配方，由洛匹那韋和利托那韋組成，裝在軟凝膠陰道插入劑中，有可能成為治療 HPV 感染和 HPV 相關子宮頸疾病的首創藥物。我們期待繼續進行必要的活動，以便向 FDA 提交 IND 申請，並開展 DIRE-HPV 的 II 期隨機安慰劑對照雙盲臨床研究，以清除女性的高危險 HPV 感染，所有這些活動都將得到我們在該 1000 萬美元獎項下獲得的資金支持。

We're excited to be able to provide more updates in the coming months on our therapeutic development programs as well as our progress as we work to commercialize some of the most potentially disruptive candidates for the health and well-being of women in decades. I'd like to now turn the call over to the operator for Q&A.

我們很高興能夠在未來幾個月內提供更多關於我們的治療開發計劃以及我們致力於將幾十年來對女性健康和福祉最具破壞性的一些候選藥物商業化的進展的更新。現在我想將電話轉給接線員進行問答。

(Operator Instructions)

（操作員指示）

Douglas Tsao, H.C. Wainwright.

Douglas Tsao、H.C. Wainwright。

I guess, Sabrina, you said that we should anticipate several different partnerships in terms of sort of the compounded distribution and products. I'm just curious, would that be unique partnerships for each product? Or could you potentially have multiple partnerships for an individual product?

我想，薩布麗娜，您說過，我們應該在複合分銷和產品方面預期幾種不同的合作夥伴關係。我只是好奇，這是否是每種產品的獨特合作關係？或者您是否有可能針對單一產品建立多個合作夥伴關係？

Yes, that's a great question. Thanks for asking for the clarification. Both. So first of all, I want to start out that we would intend to have multiple partnerships for an individual product because we want to make sure, as I mentioned, that, that product is available in as many places as possible that makes sense in terms of where women are getting their care and that, like I said, meet our objectives in terms of criteria around that platform having the right commitment and the right access to women on their platforms and where they might have complementary products as well. So for an individual product, absolutely expect several relationships to support that brand, having as wide access as possible and as it makes sense for that particular product and that particular channel being supported.

是的，這是一個很好的問題。感謝您的澄清。兩個都。首先，我想說的是，我們打算為單一產品建立多個合作夥伴關係，因為正如我所提到的，我們希望確保該產品能夠在盡可能多的地方提供，這對於女性獲得護理來說是有意義的，並且就像我說過的，滿足我們的目標，即該平台擁有正確的承諾和在其平台上與女性的正確接觸機會，並且他們可能也有互補的產品。因此，對於單一產品而言，絕對需要有多種關係來支持該品牌，並盡可能廣泛地訪問該品牌，這對於特定產品和特定管道的支援是有意義的。

But also, as I think may be intuitive, but just in case it's not. These platforms that have built fantastic relationships with the patients and consumers that use their platforms, obviously, it's very compelling for them to have access to new products and especially evidence-based treatments and opportunities to partner with DAA, which is a leading pharmaceutical developer in the area of women's health. And so there are also interesting opportunities where DAA products, multiple DAA products could be available on an individual platform as well. So over the coming -- as I said, over the coming months, expect more news from us around this, more announcements around this. But the goal is to very simply make sure that these evidence-based treatments are available for the women who are seeking them and for the health care providers that want to provide them.

但同時，我認為這可能是直觀的，但以防萬一它不是。這些平台與使用其平台的患者和消費者建立了良好的關係，顯然，對於他們來說，獲得新產品，特別是循證治療方法，以及與 DAA（女性健康領域領先的製藥開發商）合作的機會非常有吸引力。因此，也存在有趣的機會，DAA 產品，多個 DAA 產品也可以在單一平台上使用。因此，正如我所說，在接下來的幾個月裡，我們將發布更多關於此的消息和公告。但我們的目標很簡單，就是確保尋求這些治療的女性和想要提供這些治療的醫療保健提供者能夠獲得這些實證治療。

And that means we want to make sure they are on as many platforms and via as many channels as possible. And that's what the relationships and collaborations and partnerships will reflect.

這意味著我們希望確保它們出現在盡可能多的平台和頻道上。這就是關係、合作和夥伴關係將反映的。

And I guess I'm just curious, when you think about -- and this is maybe specific to sildenafil cream, target being sort of in the market by the end of the year. Is there much that you need to do to ensure that there is sufficient manufacturing capacity for the product by year-end?

我想我只是好奇，當你想到——這也許是針對西地那非乳膏的，目標是在今年年底前上市。您需要做很多事情來確保到年底有足夠的產品生產能力嗎？

Another great question. So we definitely want to make sure that our 503B collaborator on this. So under 503B, just taking a step back for a second for everyone's benefit, under 503B, the product, the statutes, the product needs to be manufactured at a registered 503B facility. And therefore, we need to support our 503B facility in how to make our proprietary Sildenafil cream, right, get them that ready. This is GMP manufacturing.

又一個好問題。所以我們肯定希望確保我們的 503B 合作夥伴能夠做到這一點。因此，根據 503B，為了大家的利益，我們先退一步來說，根據 503B，產品、法規、產品需要在註冊的 503B 工廠生產。因此，我們需要支援我們的 503B 設施，以便生產我們專有的西地那非乳膏，對，讓他們做好準備。這是GMP生產。

This is not compounding at a pharmacy. This is at an outsourcing facility, which are regulated by FDA's GMP rules and subject to FDA inspection. And therefore, there are activities that need to happen for that manufacturer to be prepared to provide the product at the scale that we need. And that's why it's fourth quarter and not yesterday that we were launching this product. And that's really what that timing is for.

這不是在藥局配藥。這是一家外包工廠，受 FDA 的 GMP 規則監管並接受 FDA 檢查。因此，製造商需要採取一些行動，做好準備，以我們所需的規模提供產品。這就是為什麼我們是第四季而不是昨天才推出這款產品。這就是時機的真正意義。

And in addition to that, though, what that gives us is some nice time between now and then to do a lot of work around provider education and medical education with the support of the medical institutions that are very focused on sexual health of women and other platforms that are focused on education of providers that are focused in that field. And so what it allows us to do in terms of other preparations is to use this time to make sure that we're supporting those providers with education around disease state and also education around our specific Sildenafil cream formulation. And so those are really the 2 -- the 3 key sets of activities that are happening between now and this product being commercially available are: one, supporting our 503B manufacturer with all the support they need to make sure they're up and running, to your point, at the scale that we want to support this exciting brand. Two, it's the partnerships and collaborations that we've been talking about to ensure the availability of the product in multiple channels and platforms. And the third is that provider education.

除此之外，從現在起，我們還可以利用這段時間在關注女性性健康的醫療機構和其他關注該領域提供者教育的平台的支持下，開展大量有關提供者教育和醫學教育的工作。因此，就其他準備而言，我們可以利用這段時間確保為這些提供者提供有關疾病狀態的教育以及有關我們特定的西地那非乳膏配方的教育。因此，從現在到該產品上市之間，實際上正在進行 2 到 3 組關鍵活動：第一，為我們的 503B 製造商提供他們所需的所有支持，以確保他們能夠正常運轉，正如您所說，達到我們希望支持的這個令人興奮的品牌的規模。二是我們一直在談論的合作夥伴關係和協作，以確保產品在多個管道和平台上可用。第三是提供者教育。

So I will say a group of us are going to be at ACOG at the end of this week, which is the American College of Obstetrics and Gynecology Conference. It's the first time Dare has a booth at the conference and really we're there for education and to provide some education around what Dare is doing and what's coming soon from our portfolio.

所以我想說，我們一群人將在本週末參加 ACOG，即美國婦產科學院會議。這是 Dare 第一次在會議上設立展位，我們的目的實際上是進行教育，並提供一些有關 Dare 正在做的事情以及我們產品組合即將推出的產品的教育。

And Sabrina, if I can, one more. I'm just curious because I think you've been talking to potential partners around Sildenafil in terms of the sort of traditional FDA-approved track. I'm curious if you've gotten feedback from potential partners and reaction broadly from others in the sort of traditional pharmaceutical industry to you taking this step.

薩布麗娜，如果可以的話，再說一句。我只是很好奇，因為我認為您一直在就西地那非與潛在合作夥伴進行討論，討論的是傳統 FDA 批准的途徑。我很好奇，您是否得到了潛在合作夥伴的回饋，以及傳統製藥業其他人對您採取這一舉措的廣泛反應。

Yes, we definitely have. And I would say the feedback has been fantastic and complementary in terms of our really being open-minded and thoughtful and creative in how we get this product out there as quickly as possible. Everyone recognizes in pharma more than anyone that drug development can take a very long time, right, decades in some cases. And we've received a lot of super positive feedback from the industry and those players in terms of how we found a way to accelerate getting a product to market that health care providers are anxious to have. And so that women aren't waiting and they can actually get something that's evidence-based and has been studied for a condition for which they are seeking an option.

是的，我們確實有。我想說的是，我們在盡快推出這款產品方面確實保持了開放的心態、深思熟慮和創造性，因此得到的反饋非常棒，而且是互補的。在製藥業，每個人都比任何人都更清楚，藥物開發可能需要很長時間，在某些情況下甚至需要幾十年。我們從業界和參與者那裡得到了很多非常積極的回饋，告訴我們如何找到一種方法來加速將醫療保健提供者渴望的產品推向市場。這樣，女性就不需要等待，她們實際上就可以獲得一些基於證據且針對她們所尋求的治療方案進行研究的藥物。

And so the feedback has really been very, very positive. And it's definitely part of, frankly, what's inspired us to really look more broadly across our portfolio, the feedback from the health care providers, the feedback from women and importantly, the feedback from our peer drug developers.

因此反饋確實非常非常正面。坦白說，這絕對是激勵我們更廣泛地審視我們的產品組合、來自醫療保健提供者的反饋、來自女性的反饋以及更重要的是來自我們的同行藥物開發商的反饋的一部分。

Catherine Novack, Jones Research.

凱瑟琳‧諾瓦克，瓊斯研究公司。

Sabrina, this is Leona on for Catherine. I'll just start with Sildenafil Phase III, what additional information has the FDA requested? And then for Ovaprene, can you provide any additional information on the potential outcomes of the interim assessment? Will you have the opportunity to increase the sample size if needed?

薩布麗娜，這是凱瑟琳的扮演者利昂娜。我先從西地那非第三階段開始，FDA 還要求哪些額外資訊？然後對於 Ovaprene，您能否提供有關中期評估的潛在結果的任何其他資訊？如果需要的話，您是否有機會增加樣本量？

Yes, both great questions. So starting with Sildenafil, yes, to put that in context. So in April, we received additional input and information request from the FDA regarded our patient-reported outcomes psychometrics. And I don't expect everyone to know what psychometrics means. But basically, that it's about your questionnaires, the test VPS reliability, is it content valid or fit for purpose.

是的，這兩個問題都很好。是的，從西地那非開始，將其放在上下文中。因此，在四月份，我們收到了 FDA 針對我們的患者報告結果心理測量提出的額外意見和資訊請求。我並不指望每個人都知道心理測量的含義。但基本上，這與你的問卷有關，測試 VPS 可靠性，內容是否有效或是否適合目的。

These are specific terms that are used around patient-reported outcomes and specifically related to both what was done in the Phase II, but also importantly, what should be done in Phase III as part of that overall final validation. And that's something, by the way, that was anticipated to be part of the Phase III plan and has been discussed with the FDA. So as you can appreciate, the psychometric analysis, it has bearing on the efficacy endpoint and also the statistical analysis plan and just what's included in the Phase III study. So we've submitted information to the FDA in response to this. We're targeting submission of additional request information along with the actual protocol incorporating that and the statistical analysis plan for the Phase III, incorporating that to the FDA.

這些是圍繞著患者報告結果使用的特定術語，具體涉及第二階段所做的事情，但更重要的是，作為整體最終驗證的一部分，第三階段應該做的事情。順便說一句，這預計將成為第三階段計劃的一部分，並已與 FDA 進行討論。因此，正如您所理解的，心理測量分析與療效終點、統計分析計劃以及第三階段研究的內容有關。因此，我們已向 FDA 提交了有關此事的資訊。我們的目標是提交額外的請求資訊以及包含該資訊的實際協議和第三階段的統計分析計劃，並將其納入 FDA。

We're targeting by the end of this quarter. And that's why I'd say this is -- while we would like to target commencement and are targeting commencement of the Phase III study this year, that's really pending us getting this into the FDA and then obviously, their review and then any additional feedback we might get in response of this because obviously, we want the Phase III trial that is ultimately conducted to be very clearly reflective of everything the FDA needs to see in it in order for it to be supportive of registration. And then in terms of Ovaprene and the Data Safety Monitoring Board meeting that's scheduled for this July. So as the name is, it is a safety meeting. They're really looking at the safety and the integrity of the study.

我們的目標是在本季末實現。這就是為什麼我要說這一點——雖然我們希望今年開始併計劃開始第三階段的研究，但這實際上取決於我們將它提交給 FDA，然後顯然還要經過他們的審查，以及我們可能得到的任何其他反饋，因為顯然，我們希望最終進行的第三階段試驗能夠非常清楚地反映 FDA 需要看到的所有內容，以支持註冊。然後就 Ovaprene 和定於今年 7 月舉行的資料安全監測委員會會議而言。顧名思義，這是一場安全會議。他們確實關注研究的安全性和完整性。

That's what their charter requires them to do. And -- in terms of -- it's not an analysis and a planned review for sample size, but that's not their goal. And in fact, there will not be any statistical assessment of the primary endpoint of the study, and that's the kind of thing that would be needed if there was going to be a sample size change. It's really just looking at safety. Now having said that, and I've said this a few times, which I think is sometimes surprising to people, but 2 things.

這就是他們的章程要他們做的事。並且——就——而言，這不是對樣本量的分析和計劃審查，但這不是他們的目標。事實上，不會對研究的主要終點進行任何統計評估，而如果樣本量發生變化，就需要進行統計評估。這其實只是為了安全。現在我已經說過了，而且我已經說過幾次了，我認為這有時會讓人們感到驚訝，但有兩件事。

One, this is an open-label study. It is open label. Everyone is on Ovaprene. And two, a pregnancy in a contraceptive study is considered an adverse event. So they will be looking at those data in that context, but there will be no assessment of the actual Pearl index, which is the primary endpoint in the study.

首先，這是一項開放標籤研究。它是開放標籤的。每個人都在使用 Ovaprene。其次，避孕研究中的懷孕被視為不良事件。因此，他們會在這種背景下查看這些數據，但不會對實際的 Pearl 指數（即研究的主要終點）進行評估。

And there is no opportunity, therefore, to do any kind of sample study size changes based on that because there won't be any assessment of the primary endpoint.

因此，沒有機會基於此進行任何類型的樣本研究規模變更，因為不會對主要終點進行任何評估。

Great. And if I could just ask a couple more add-ons. For the compounding drugs, are you pursuing a dual path for all 4 of those products? I guess you've kind of answered this, but what kind of marketing and KOL outreach are you doing for the ones that were mentioned today, the probiotics and then the hormone therapy?

偉大的。我是否可以再問幾個附加問題？對於複方藥物，您是否對這四種產品都追求雙重途徑？我想您已經回答了這個問題，但是對於今天提到的益生菌和荷爾蒙療法，您正在做什麼樣的行銷和 KOL 推廣呢？

Yes. So to clarify, so sildenafil and the hormone therapy are both dual path products. So there are prescription. They'll be available via compounding under 503(b) statute as a prescription, and then we are pursuing a dual path and that we are continuing our efforts and activities to support ongoing development of those products through -- for both of them, it would be the 505(b)(2) regulatory pathway to get a treatment indication. For the vaginal probiotics, those are consumer health brands.

是的。因此需要澄清的是，西地那非和荷爾蒙療法都是雙途徑產品。所以有處方。它們將根據 503(b) 法規以處方形式透過配製提供，然後我們將採取雙重途徑，並將繼續我們的努力和活動來支持這些產品的持續開發 - 對於這兩種產品，都將透過 505(b)(2) 監管途徑獲得治療指徵。對陰道益生菌來說，這些都是消費者健康品牌。

So for products of that nature, while one could certainly choose to pursue an FDA approval for products of that nature to get some sort of treatment claim if they wanted, we're not interested in that. These are really products designed to restore a vaginal microbiome. And so that is not necessary, and there's no other work we're going to be doing on those other than making those available in the United States. And in terms of efforts to kind of educate and support the primary effort right now on the part of Dare is very much focused around Sildenafil. -- and then there'll be more efforts on the hormone therapy next year.

因此，對於此類產品，雖然人們當然可以選擇尋求 FDA 批准以獲得某種治療功效，但我們對此不感興趣。這些確實是旨在恢復陰道微生物群的產品。所以這不是必需的，除了在美國提供這些之外，我們不會做任何其他工作。在教育和支持方面，Dare 目前的主要努力集中在西地那非上——明年將在荷爾蒙療法方面做出更多努力。

The good news is it's all the same KOLs and it's all the same medical societies that really focus on both sexual health and menopause. And so we'll be focusing on education programs right now around Sildenafil and its availability. But we're also doing a lot to just awareness around Dare and what we are doing as a leader in ensuring that these evidence-based treatments take it to women and making sure that the health care providers are educated on them. So that will really be our focus in the near term, a lot of focus around Sildenafil and as we get into next year, even more focus on the hormone therapy as well. And then obviously, we're making -- the consumer health brand is a little bit of a different channel, although we do think that there are a lot of health care providers that are very interested in having a natural evidence-based solution that they can make available to their patients.

好消息是，所有 KOL 和醫學協會都真正關注性健康和更年期。因此，我們現在將重點放在有關西地那非及其可用性的教育計劃。但是，我們也在做大量工作來提高人們對 Dare 的認識，並作為領導者確保這些循證治療方法能夠惠及女性，並確保醫療保健提供者了解這些治療方法。因此，這確實會是我們近期的重點，重點關注西地那非，而進入明年，我們將更加關注荷爾蒙療法。顯然，我們正在打造——消費者健康品牌是一個略有不同的管道，儘管我們確實認為有許多醫療保健提供者對能夠為患者提供的自然循證解決方案非常感興趣。

So we will opportunistically make sure that they're educated on those as well.

因此，我們將抓住機會確保他們也接受這方面的教育。

(Operator Instructions)

（操作員指示）

Will Hidell, Brookline Capital Markets.

布魯克林資本市場 (Brookline Capital Markets) 的威爾希德爾 (Will Hidell)。

Sabrina, quick question regarding Ovaprene, the trial. Does the grant received in November cover cost to add additional sites? I know you mentioned in the Q about adding potentially 2 or 3 new sites. Does that grant cover those costs?

薩布麗娜，關於 Ovaprene 試驗的快速問題。11 月收到的撥款是否涵蓋增加額外站點的費用？我知道您在問題中提到可能增加 2 或 3 個新網站。這筆補助金能涵蓋這些費用嗎？

Yes. Thank you. Great question, too. Yes. So the way the grant works, it is really designed to cover the cost of adding a certain number of additional subjects to the study.

是的。謝謝。這也是個好問題。是的。因此，資助的運作方式實際上是為了支付在研究中增加一定數量的額外受試者的費用。

And we've focused initially on 5 sites, which, frankly, at the rates they're going, can be sufficient to add those additional subjects in a very reasonable time frame. So we're going to look at whether there are other sites that we need to open as well. Right now, we're really happy with the pace of enrollment at the 5 sites, but we definitely have some flexibility to add some additional sites as well.

我們最初重點關注 5 個站點，坦白說，以目前的速度，足以在非常合理的時間範圍內添加這些額外的主題。因此，我們將看看是否還有其他站點需要開放。目前，我們對這 5 個站點的招生速度感到非常滿意，但我們當然也可以靈活地添加一些其他站點。

Okay. Great. And then R&D came in a little lower than last quarter. Should we expect that number to continue going forward? Or should we see an uptick in that?

好的。偉大的。研發支出比上一季略低。我們是否應該預期這個數字會持續成長？或者我們應該看到它出現上升趨勢嗎？

Right now, thanks for asking for that clarification, by the way. Right now, the only ongoing study at this time is the Ovaprene study. And as we were just talking about, the activities right now are really funded with the grant funding we receive. We do have sometimes, and Mardee kind of alluded to this, other costs associated with Ovaprene and those were in, I think, the Q as well related to manufacturing, just other things that we're doing, obviously, to support the product and certain other activities that we might want to kind of lean into even related to the study, sometimes like advertising, things like that. But what you've seen in terms of those trends is really reflective of the fact that we don't have other ongoing studies at this time.

順便說一句，現在感謝您要求澄清。目前，唯一正在進行的研究是 Ovaprene 研究。正如我們剛才所說，目前的活動實際上是由我們收到的贈款資助的。我們確實有時會產生與 Ovaprene 相關的其他成本，Mardee 也提到了這一點，我認為這些成本也與製造有關，只是我們正在做的其他事情，顯然是為了支持產品和某些其他活動，我們可能想要傾向於甚至與研究相關的活動，有時像廣告之類的事情。但您看到的這些趨勢實際上反映了我們目前沒有其他正在進行的研究。

And so until we do, that's the kind of trend you should expect to continue to see until we have other studies going on at this time.

因此，在我們這樣做之前，這種趨勢應該會繼續存在，直到我們同時進行其他研究。

Okay. If I could ask one more. With Sildenafil cream, you mentioned, I think, last quarter that you needed about $1 million to get the 503B operations going. Does that apply to the additional products? Or will there be an additional cost?

好的。如果我可以再問一個。關於西地那非乳膏，我記得您上個季度提到過，需要大約 100 萬美元來啟動 503B 業務。這適用於附加產品嗎？或會產生額外費用？

That's another great question. Yes, that's very specific to Sildenafil. So that's really the cost associated with supporting our 503B manufacturer with the start-up tech transfer activities like that, that are needed to produce GMP Sildenafil cream product. There would be additional costs associated with production activities and tech transfer activities associated with the hormone therapy product. They're in a similar range as that, but it's because it's for those similar kinds of activities.

這又是一個很好的問題。是的，這與西地那非非常相關。因此，這實際上是支持我們的 503B 製造商開展生產 GMP 西地那非乳膏產品所需的啟動技術轉移活動的成本。與荷爾蒙治療產品相關的生產活動和技術轉移活動會產生額外的成本。它們處於相似的範圍內，但這是因為它們適用於類似的活動。

It's basically to ensure that the manufacturer under GMP has the opportunity to do all the things that are required under GMP and has all of the right equipment and things like that. So as we get closer, the Dare-HRT1, the hormone therapy product is really targeted for next year. So as we continue to progress on that and get closer, we'll be able to give even better guidance around that and what those costs are. But it's the same kind of ballpark, right? We're talking single-digit millions and not tens of millions.

這基本上是為了確保 GMP 下的製造商有機會完成 GMP 要求的所有事情，並擁有所有正確的設備等等。因此，隨著我們越來越接近，荷爾蒙治療產品 Dare-HRT1 確實計劃在明年推出。因此，隨著我們在這方面不斷取得進展並越來越接近目標，我們將能夠就此問題以及相關成本提供更好的指導。但它是同一種球場，對嗎？我們談論的是幾百萬，而不是幾千萬。

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

今天的問答環節到此結束。我想將電話轉回給薩布麗娜·馬圖奇·約翰遜，請她做任何補充或結束語。

Great. Well, thank you all for taking the time this afternoon and special thanks for the really thoughtful questions. I'll close with basically the same comment I made upfront. repetition is important sometimes, which is that Dare is uniquely positioned to cut through the noise and deliver value to all of our stakeholders, women, health care providers and investors. Today, biopharmaceutical companies with relatively low-risk assets, a competitive advantage and a path towards near-term revenue are positioned to offer upside.

偉大的。好吧，感謝大家今天下午抽出時間，特別感謝你們提出這些非常有想法的問題。最後，我將以我一開始所做的相同評論作為結束。重複有時很重要，這意味著 Dare 具有獨特的優勢，可以消除噪音並為我們所有的利害關係人、女性、醫療保健提供者和投資者創造價值。如今，擁有相對低風險資產、競爭優勢和短期獲利途徑的生物製藥公司有望獲得上行空間。

And as I said upfront, we believe that is Dare today. I can't stress enough that women's health is ripe for returns. It has been so underfunded and fragmented. And with our recently announced expanded business strategy, we believe we're uniquely positioned to deliver that value and returns to all of the stakeholders. With this business model that I hope you will agree is nimble, allowing us to rapidly commercialize multiple products via multiple channels.

正如我之前所說的，我們相信這就是今天的挑戰。我再怎麼強調也不為過，女性的健康已經到了值得回報的階段。它一直資金嚴重不足，而且支離破碎。透過我們最近宣布的擴大業務策略，我們相信我們擁有獨特的優勢，可以為所有利害關係人提供價值和回報。我希望你們會同意這種商業模式非常靈活，它使我們能夠透過多種管道快速將多種產品商業化。

Four on-market products will accelerate revenue generation and provide a path to profitability, and we expect to start recording revenue in the fourth quarter of this year. The portfolio is compelling. And over the next months, as I've said, we look forward to providing updates regarding strategic partnerships and collaborations to facilitate access to our on-market brands for women across multiple channels. Thank you for listening today and for your support.

四種上市產品將加速創收並提供獲利途徑，我們預計今年第四季開始記錄收入。該產品組合非常引人注目。正如我所說，在接下來的幾個月裡，我們期待提供有關戰略合作夥伴關係和合作的最新信息，以方便女性透過多種管道獲得我們的市場品牌。感謝您今天的收聽和支持。

Thank you, everyone, and that concludes today's call. Thank you all for joining. You may now disconnect. Have a nice day ahead.

謝謝大家，今天的電話會議到此結束。感謝大家的加入。您現在可以斷開連線。祝您有個愉快的一天。