Dare Bioscience Inc (DARE) 2025 Q3 法說會逐字稿

Welcome to the conference call hosted by Dare Bioscience to review the company's third quarter 2025 financial results and to provide a business update. This call is being recorded. My name is Jerko, 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. Haring-Layton, please proceed.

歡迎參加由Dare Bioscience主辦的電話會議，本次會議旨在回顧公司2025年第三季財務業績並提供業務最新進展。本次電話會議正在錄音。我是Jerko，今天將擔任本次會議的接線生。今天出席會議的Dare Bioscience代表有總裁兼執行長Sabrina Martucci Johnson女士和首席會計官MarDee Haring-Layton女士。 Haring-Layton女士，請開始。

Good afternoon and welcome to the Dare Bioscience financial results and business update call for the quarter ended September 30, 2025. Today, we will review our financial results, provide updates on our clinical pipeline, and discuss the continued execution of our expanded business strategy.

下午好，歡迎參加Dare Bioscience截至2025年9月30日的季度財務業績和業務更新電話會議。今天，我們將回顧我們的財務業績，提供臨床研發管線的最新進展，並討論我們不斷擴展的業務策略的持續執行情況。

That strategy includes a dual path approach commercializing proprietary formulations through 503B compounding while pursuing FDA approval and advancing select solutions as branded consumer health products that do not require a prescription. In all cases, our goal is to bring innovative women's health solutions to market as efficiently and quickly as possible.

此策略包括雙管齊下：一方面透過503B複配計畫將專有配方商業化，另一方面尋求FDA批准，並將部分解決方案以無需處方即可購買的品牌消費者保健產品形式推出。我們始終致力於以最高效、最快捷的方式將創新的女性健康解決方案推向市場。

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 fact should be considered forward-looking statements.

我想提醒各位，今天的討論將包含符合聯邦證券法定義的“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。本次電話會議中任何非歷史事實的陳述都應視為前瞻性陳述。

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 in the company's SEC filings, including our Form 10-Q, for the quarter ended September 30, 2025. Which was filed today in our Form 10-K for the year ended December 30, 2024.

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聲明中預期或暗示的內容有重大差異。您不應過度依賴前瞻性聲明。前瞻性聲明受本公司向美國證券交易委員會（SEC）提交的文件（包括截至2025年9月30日的季度報告10-Q表，以及今天提交的截至2024年12月30日的年度報告10-K表）中的警示性聲明的完整約束。

Please note that the content of this call includes time sensitive information that is current only as of today, November 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 would also like to point out that when we use the term 503B compounding during this discussion.

請注意，本次電話會議的內容包含時效性訊息，僅截至2025年11月13日有效。除法律要求外，Dare不承擔在本次電話會議後更新任何前瞻性聲明以反映新資訊或進展的義務。此外，我想指出，我們在本次討論中使用“503B複利”一詞時，請注意其含義。

We are referring to compounding drug products by outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetics Act using both drug substances on the FDA's interim Category One list. I will now turn the call over to Sabrina.

我們指的是透過外包機構，利用根據《聯邦食品、藥品和化妝品法案》第503B條註冊的機構，使用FDA臨時一級清單上的兩種藥物成分來配製藥品。現在我將把電話交給薩布麗娜。

Thank you, Mardee, and thank you everyone joining us today. Dare at an inflection point. The third quarter of 2025 reflects the continued acceleration of our dual path strategy as we focus on closing the gap in women's health between promising science and real-world solutions for women, generating near-term commercial revenue while advancing long-term innovation.

謝謝 Mardee，也謝謝今天所有到場的各位。我們正處於一個關鍵的轉折點。 2025 年第三季標誌著我們雙軌策略的持續加速推進，我們將致力於彌合女性健康領域中前景廣闊的科學成果與切實可行的解決方案之間的差距，在創造近期商業收益的同時，推進長期創新。

We remain on track to support the commercial availability of Dare to Play Sildenafil cream through a 503B outsourcing facility before the end of this year. This anticipated launch represents a major milestone, not just for Dare but for the field of women's sexual health, where innovation has historically lagged behind other therapeutic areas.

我們仍按計畫推進，將於今年年底前透過503B外包機制支援Dare to Play西地那非乳膏的商業化上市。此次上市不僅對Dare而言意義重大，對女性性健康領域也是如此，該領域的創新歷來落後於其他治療領域。

At the same time, we continue to advance our differentiated clinical pipeline, which includes primarily grant-funded programs targeting areas of significant unmet need, including contraception, human papillomavirus infection, and preterm birth. We believe this dual path approach enables us to unlock value efficiently by leveraging non-diutive capital and a disciplined investment strategy.

同時，我們持續推動差異化的臨床研發管線，其中主要包括由科研基金資助的項目，這些項目針對的是亟待滿足的重大醫療需求領域，例如避孕、人類乳突病毒感染和早產。我們相信，這種雙管齊下的策略能讓我們透過利用非債務資本和嚴謹的投資策略，有效率地釋放價值。

I'll walk you through several highlights from across our portfolio, but before doing so, I want to share reflections on our business model that I shared last week on a panel at the Milken Institute's Women's Health Network event when I was interviewed by former First Lady Doctor Jill Biden, who chairs the Milken Institute's Women's Health Network Steering Committee on which I serve.

我將帶您了解我們投資組合中的幾個亮點，但在那之前，我想分享一下我上週在米爾肯研究所女性健康網絡活動的一個小組討論中分享的關於我們商業模式的一些思考。當時，我接受了前第一夫人吉爾·拜登醫生的採訪，她擔任米爾肯研究所女性健康網絡指導委員會主席，而我也是該委員會的成員。

Dr. Biden asked me specifically how crossing traditional boundaries and partnering in new ways has helped Dare to stand out and grow. As you know Dare Bioscience is a purpose-driven health biotech with a sole focus on closing the gap between that promising science and those real-world solutions for women, from contraception to menopause, pelvic pain to fertility, Sexual health to infectious disease, we're working to close those critical gaps in care using science that serves her needs to specifically design, test, and deliver trusted medical grade solutions for women.

拜登博士特別問我，打破傳統界線、探索全新合作模式是如何幫助Dare脫穎而出、蓬勃發展的。如您所知，Dare Bioscience是一家以目標為導向的健康生物技術公司，專注於彌合前景廣闊的科學研究與女性實際解決方案之間的差距。從避孕到更年期，從骨盆腔疼痛到生育力，從性健康到傳染病，我們致力於運用科學滿足女性需求，設計、測試並提供值得信賴的醫用級解決方案，從而彌合這些關鍵的醫療缺口。

So in response to Dr. Biden's question, I shared that during my decades-long career in life sciences, I've seen a lot of innovation just sitting by the sidelines, right products with interesting proof of concept or science that we understood, but had not advanced in development, and that's what inspired me to create a company laser focused on accelerating the process from discovery through development to market.

因此，在回答拜登博士的問題時，我分享說，在我數十年的生命科學職業生涯中，我看到很多創新成果被擱置一旁，它們擁有正確的產品、有趣的概念驗證或我們理解的科學原理，但卻沒有推進開發，這激勵我創建一家專注於加速從發現到開發再到上市過程的公司。

And I wanted to do this specifically for innovations for health conditions affecting women, so women aren't left waiting for the care they need now and the way we accelerate it is specifically through collaborations.

我希望專門針對影響女性的健康狀況進行創新，這樣女性就不會再等待她們現在需要的護理，而我們加速這一進程的方式正是透過合作。

Women's health breakthroughs often start in academic labs or single product companies that lack all of the resources to translate ideas into products. So even when the science is solid, there's a disconnect between clinical development, regulatory approval, and how women actually access care and at Dare we are trying to bridge those gaps by connecting the dots early, by partnering early with the academic innovators and small companies, leveraging public funding sources like NIH, ARPA-H, and the Gates Foundation, and working directly and in parallel with clinicians and commercialization partners to ensure that solutions reach women quickly.

女性健康領域的突破性進展往往始於學術實驗室或單一產品公司，而這些機構往往缺乏將理念轉化為產品所需的全部資源。因此，即使科學基礎紮實，臨床開發、監管批准以及女性實際獲得醫療服務之間仍然存在脫節。在Dare，我們致力於彌合這些差距，透過早期整合各方資源，與學術創新者和小公司建立合作關係，利用美國國立衛生研究院 (NIH)、美國高級研究計畫署 (ARPA-H) 和蓋茲基金會等公共資金來源，並與臨床醫生和商業化合作夥伴直接協作，確保解決方案能夠迅速惠及女性。

At Dare we're turning that rigorous science into real world solutions delivered with urgency, and this is where I think women's health can lead the broader healthcare industry, not just follow it. By turning on their head the outdated models that separate research, funding, access, so we don't lose time and impact.

在Dare，我們致力於將嚴謹的科學研究轉化為切實可行的解決方案，並以緊迫的方式交付。我認為，女性健康可以引領整個醫療保健產業的發展，而不僅僅是跟隨它。我們要徹底顛覆那些將研究、資金和醫療服務割裂開來的過時模式，這樣才能避免浪費時間和精力，並產生更大的影響力。

So connecting the dots early, designing collaborations around the outcomes we want, which is to move promising science into the hands of women faster and Dare to Play Sildenafil cream is a great example of this.

因此，儘早建立聯繫，圍繞我們想要的結果設計合作，也就是更快地將有前景的科學成果送到女性手中，「敢於嘗試西地那非乳膏」就是一個很好的例子。

The idea started as a simple question, why should a well understood drug that helps blood flow in men not be available in a formulation designed for women?

這個想法源自於一個簡單的問題：為什麼一種對男性血液循環有益的藥物，不能有專為女性設計的配方呢？

We took a well-understood molecule with decades of safety and efficacy data in men, identified and added to our portfolio a topical formulation designed specifically for women.

我們選取了一種在男性中擁有數十年安全性和有效性數據的、已被充分了解的分子，並確定了一種專為女性設計的局部用藥配方，並將其添加到我們的產品組合中。

And tested it clinically to demonstrate effect. While we continue pursuing regulatory approval of what would be the first FDA approved treatment for arousal disorder in women, we are strategically partnering with a 503B outsourcing facility so that our proprietary formula can be accessible via prescription as a compounded drug this year. Women should not have to wait for access to this solution.

我們已透過臨床試驗驗證了其療效。目前，我們正積極尋求FDA批准該藥物，使其成為首個獲準用於治療女性性喚起障礙的FDA核准藥物。同時，我們正與一家503B外包機構建立策略合作夥伴關係，以便今年就能以複方藥物的形式透過處方取得我們的專利配方。女性不應再為獲得此解決方案而苦苦等待。

The channel allows us to accelerate women's access to our proprietary formula while discussions with the FDA continue on defining acceptable endpoints for a future FDA registration path.

該管道使我們能夠加快女性獲得我們專有配方的速度，同時我們繼續與 FDA 討論確定未來 FDA 註冊途徑的可接受終點。

The third quarter was a pivotal period for Dare as we advanced towards the commercial introduction of Dare to Play Sildenafil cream through the 503B outsourcing facility pathway, and our focus continues to be on execution. We remain on track for our 503B outsourcing facility partner to begin fulfilling prescriptions in select states in December.

第三季對Dare而言至關重要，我們正透過503B外包機制推進Dare to Play西地那非乳膏的商業化上市，目前我們仍專注於執行。我們的503B外包機制合作夥伴預計將在12月開始在部分州提供處方服務，我們對此仍保持著良好的預期。

In addition to the federal requirements overseen by the FDA, 503B outsourcing facilities are also subject to state-specific requirements, and we expect Dare to Sildenafil cream prescriptions will be available to be fulfilled in all 50 states in early 2026.

除了 FDA 監管的聯邦要求外，503B 外包機構還需遵守各州的具體要求，我們預計 Dare to Sildenafil 乳膏處方將於 2026 年初在所有 50 個州均可配藥。

This milestone will mark the first time a topical Sildenafil formulation designed specifically for women, manufactured in accordance with GMP requirements and supported by clinical data demonstrating increased genital blood flow within 10 minutes to 15 minutes of application and improvements in arousal sensation using clinically validated and FDA reviewed endpoints will be available for women.

這一里程碑標誌著首個專為女性設計的局部西地那非製劑將上市，該製劑按照GMP要求生產，並有臨床數據支持，證明塗抹後10至15分鐘內可增加生殖器血流量，並通過臨床驗證和FDA審查的終點指標改善性喚起感覺。

Our collaboration with the 503B manufacturing partner specializing in topical formulations, and [Midvantix], our pharmacy services and logistics partner, positions us to deliver high-quality, compliant, and scalable product access beginning this year.

我們與專門從事外用製劑的 503B 製造合作夥伴以及我們的藥房服務和物流合作夥伴 [Midvantix] 開展合作，使我們能夠從今年開始提供高品質、合規且可擴展的產品。

We are supporting the 503B launch through targeted medical education initiatives, patient and clinician resources on www.daretoplaybio.com, and engagement programs that emphasize the clinical differentiation and unmet need addressed by this innovation. We believe the product's positioning, science-backed, evidence-driven, and female-focused, sets a new benchmark for credibility in the female sexual wellness category.

我們正透過有針對性的醫學教育計劃、www.daretoplaybio.com 網站上的患者和臨床醫生資源，以及強調該創新產品臨床差異化優勢和未滿足需求的互動項目，支持該產品獲得 503B 認證。我們相信，該產品以科學為依據、以證據為驅動、以女性為中心，其定位為女性性健康領域樹立了新的信譽標竿。

Our next webinar titled The Dare to Play Difference, Sildenafil cream that raises the bar will feature renowned experts, Doctor Sheryl Kingsberg and Doctor James Simon, both former Presidents of the International Society for the Study of Women's Sexual Health and the Menopause Society.

我們下一場網路研討會的主題是“敢於嘗試的差異：西地那非乳膏提升標準”，將邀請著名專家謝麗爾·金斯伯格博士和詹姆斯·西蒙博士，他們都是國際女性性健康研究協會和更年期協會的前任主席。

The discussion will explore Dare to Play formulation science, clinical evidence showing improved genital blood flow and arousal outcomes, and critical clinician insights on why Dare to Play Sildenafil cream will set new standards in women's sexual arousal healthcare.

本次討論將探討 Dare to Play 的配方科學、臨床證據（顯示其可改善生殖器血流和性喚起效果）以及臨床醫生的重要見解，闡述為什麼 Dare to Play 西地那非乳膏將在女性性喚起保健領域樹立新標準。

You can find the link to join the webinar at https://cvent.me/KO1obd. Also on our website in the investor section.

您可以透過以下連結加入網路研討會：https://cvent.me/KO1obd。您也可以造訪我們網站的投資者關係版塊查看連結。

We believe this is a large under-recognized market where the promise of sildenafil, the same active ingredient in an oral erectile dysfunction drug, is recognized, but the clinical evaluation of topical Sildenafil formulations for women has been lacking. We therefore believe that Dare to PIay Sildenafil Cream is poised to be the first meaningful prescription innovation in this category. And we are excited about its potential as a near term revenue driver.

我們認為這是一個尚未被充分重視的龐大市場，西地那非（與口服勃起功能障礙藥物的活性成分相同）的潛力已得到認可，但針對女性外用西地那非製劑的臨床評估卻一直不足。因此，我們相信 Dare to PIay 西地那非乳膏有望成為該領域首個真正意義上的處方創新產品。我們對它有望在短期內帶來可觀的收入成長感到興奮。

Please visit the daretoplaybio.com website for product updates and access alerts so that you can be among the first to know when this only evidence-based Sildenafil cream formulation for women, Dare to Play Sildenafil cream, becomes available.

請造訪 daretoplaybio.com 網站獲取產品更新和訪問提醒，以便您能第一時間了解這款唯一基於循證醫學的女性專用西地那非乳膏配方——Dare to Play 西地那非乳膏上市的情況。

And following Dare to Play, we plan to expand our commercial portfolio with the introduction of our Dare to Restore product line, proprietary vaginal probiotic products designed to support the vaginal microbiome. Things which will not require a physician's prescription align with our broader vision to integrate clinically credible, evidence-based products into women's health routines, including select consumer health products.

繼「敢於玩樂」（Dare to Play）系列之後，我們計劃推出「敢於修復」（Dare to Restore）產品線，進一步拓展我們的商業產品組合。此系列產品為專有的陰道益生菌產品，旨在支持陰道微生物群的健康。無需醫生處方即可購買的產品，符合我們更廣泛的願景，即把具有臨床可信度和循證依據的產品融入女性的日常健康護理中，包括部分消費保健產品。

Our goal is simple, to bridge the innovation gap and ensure that women have access to the tools to support their intimate health. To that end, we seek to leverage innovative, science-backed vaginal health approaches developed in Europe and are already being used by women in countries where they're available, and we look forward to bringing these differentiated evidence-based products to women in the United States.

我們的目標很簡單，就是要彌補創新差距，確保女性能獲得維護私密健康的工具。為此，我們致力於推廣歐洲研發的、以科學為依據的創新陰道健康方法，這些方法目前已在相關國家得到應用。我們期待將這些差異化的、實證的產品帶給美國女性。

We're targeting to make to Dare to Restore vaginal probiotic products available in the US in the first quarter of 2026. We're also taking action to bring our combination estradiol and progesterone intravaginal ring to market via Section 503B as well.

我們的目標是在 2026 年第一季在美國推出 Dare to Restore 陰道益生菌產品。我們也將透過 503B 條款採取行動，將我們的雌二醇和黃體酮組合陰道環推向市場。

The compounded product will be branded as Dare to Reclaim and is designed for women to experience perimenopause and menopause. We're targeting to have Dare to Reclaim available in early 2027.

這款複合產品將命名為“Dare to Reclaim”，專為經歷圍絕經期和更年期的女性設計。我們計劃在2027年初推出「Dare to Reclaim」。

There are no FDA approved products that provide estradiol and progesterone together in a non-oral monthly form. We are pursuing both a traditional FDA approval path and a 503B compounding opportunity similar to our dual path strategy for Sildenafil cream. We believe this approach allows us to accelerate patient access while continuing to generate the data necessary to seek FDA approval and support longer-term value creation.

目前尚無獲得FDA批准的非口服、每月一次的雌二​​醇和孕酮聯合製劑。我們正在同時推進傳統的FDA審批途徑和503B複方製劑項目，類似於我們先前為西地那非乳膏制定的雙管齊下策略。我們相信，這種方法能夠加快患者用藥速度，同時持續累積申請FDA批准所需的數據，並支持長期價值創造。

Dare to Reclaim will be a one-of a-kind evidence-based solution in the estimated $4.5 billion dollar compounded hormone therapy market, and we believe it can generate meaningful revenue alongside Dare to Play Sildenafil cream. Our near-term commercial initiatives are designed not only to drive revenue but also to create a self-reinforcing ecosystem for growth.

Dare to Reclaim 將成為價值約 45 億美元的複合激素療法市場中獨一無二的循證解決方案，我們相信它能與 Dare to Play 西地那非乳膏一起創造可觀的收益。我們近期的商業措施不僅旨在推動營收成長，更旨在創造一個自我強化的成長生態系統。

The commercial experience, the brand awareness, the provider engagement generated through these products can position us to efficiently introduce additional pipeline candidates, including potential future FDA approved products. And by pursuing a balanced strategy that integrates short-term commercial execution with long-term R&D investment.

透過這些產品累積的商業經驗、品牌知名度和供應商互動，使我們能夠有效率地推出更多在研產品，包括未來可能獲得FDA批准的產品。同時，我們採取平衡的策略，將短期商業執行與長期研發投資結合。

We aim to reduce the reliance on dilutive capital and build a financially sustainable model for innovation in women's health. And our programs that are supported with grant funding, including work in contraception and HPV continue to advance with important [nonilutive] support.

我們的目標是減少對稀釋性資本的依賴，並為女性健康領域的創新建立一個財務可持續的模式。同時，我們獲得資助的項目，包括避孕和人類乳突病毒（HPV）方面的工作，也在重要的非稀釋性支持下繼續推進。

Let's start first with Ovaprene. Enrollment is ongoing in our pivotal phase 3 multi-enter single-arm non-comparative clinical study of Ovaprene to evaluate its effectiveness as a contraceptive along with its safety and acceptability. We intend to maintain active recruitment at five study sites supported by grant funding we received in November 2024.

我們先來說說Ovaprene。我們正在進行一項關鍵性的III期多中心單臂非對照臨床研究，旨在評估Ovaprene作為避孕藥的有效性、安全性和耐受性，目前正在招募受試者。我們計劃在五個研究中心繼續積極招募受試者，這些研究中心由我們於2024年11月獲得的資助支持。

We currently anticipate enrollment will be completed in 2026, and we plan and look forward to providing further updates regarding anticipated enrollment and study completion targets next year.

我們目前預計招募工作將於 2026 年完成，我們計劃並期待明年提供有關預期招募和研究完成目標的進一步更新。

We announced in July that the Independent Data Safety Monitoring Board reviewed the interim data from the phase 3 study and recommended that the trial continue as planned. There were no new safety or tolerability concerns or serious safety concerns identified, and the interim pregnancy rate of women treated in the study was consistent with our expectations based on our prior postcoital test study of Ovaprene.

我們在7月宣布，獨立資料安全監察委員會審查了3期研究的中期數據，並建議試驗按計畫繼續進行。未發現新的安全性或耐受性問題，也未發現嚴重安全問題，且研究中接受治療的女性的中期妊娠率與我們基於先前Ovaprene性交後試驗研究的預期一致。

These data support Ovaprene potential to fill a significant gap in the contraceptive landscape, providing women with a non-hormonal user-controlled option without daily interruption. With millions of women in the US seeking effective hormone-free birth control.

這些數據表明，Ovaprene 有潛力填補避孕領域的重大空白，為女性提供一種無需每日服用、可自行控制的非荷爾蒙避孕選擇。在美國，數百萬女性正在尋求有效的無激素避孕方法。

Ovaprene has the potential to address a significant [unmed] need and transform the contraceptive landscape. We look forward to the completion of the study and the final analysis of study endpoints, including the primary endpoint of pregnancy rate, which is calculated using the Pearl Index.

Ovaprene可望滿足一項重要的未開發藥物需求，並改變避孕領域的格局。我們期待這項研究的完成以及對研究終點的最終分析，包括使用Pearl指數計算的主要終點——懷孕率。

Recall that Bayer received the right to obtain exclusive US rights to commercialize the product following completion of this pivotal clinical trial if Bayer, in its sole discretion makes a $20 million payment to Dare. Dare may receive up to $310 million in commercial milestone payments plus double-digit tiered royalties on net sales.

請注意，如果拜耳自行決定向Dare支付2000萬美元，則拜耳將在完成這項關鍵性臨床試驗後獲得該產品在美國的獨家商業化權利。 Dare可能獲得高達3.1億美元的商業里程碑付款，以及基於淨銷售額的兩位數階梯式特許權使用費。

The potential $20 million payment and royalty payments are subject to a third-party's minority interest under a royalty purchase agreement entered into in April 2024. We're also continuing to advance programs supported entirely by non-diluted funding awards.

這筆潛在的 2000 萬美元款項和特許權使用費取決於第三方根據 2024 年 4 月簽訂的特許權使用費購買協議所持有的少數股權。我們也在繼續推進完全由未稀釋的資金獎勵支持的項目。

DARE-HPV is in development as a novel intravaginal therapy for persistent high-risk human papillomavirus infection. That's the virus that causes cervical cancer. The program is currently funded through an award from ARPA-H and an NIH grant.

DARE-HPV 正在研發中，是一種用於治療持續性高風險型人類乳突病毒感染的新型陰道內療法。這種病毒是導致子宮頸癌的罪魁禍首。該計畫目前由美國高級研究計畫署（ARPA-H）的撥款和美國國立衛生研究院（NIH）的資助。

DARE-LARC1 is a pre-clinical stage long-acting contraceptive intended to offer multi-year protection with remote pause resume control. A $6 million grant installment was received in July and a $4 million installment was just received last month.

DARE-LARC1 是一種處於臨床前階段的長效避孕藥，旨在提供多年保護，並具備遠端暫停/恢復控制功能。該計畫於 7 月收到 600 萬美元的撥款，上個月又收到 400 萬美元的撥款。

And their NHC is a preclinical research program that will aid in the identification and development of a novel non-hormonal intravaginal contraceptive product candidate. The grant funding supports activities to de-risk the development of a novel non-hormonal intravaginal contraceptive that can be suitable for and acceptable to women in low and middle income country settings who need or would prefer to use such a product to avoid an unplanned pregnancy.

他們的NHC計畫是一項臨床前研究計劃，旨在幫助識別和開發一種新型的非荷爾蒙陰道內避孕候選產品。此計畫資助的活動旨在降低新型非荷爾蒙陰道內避孕產品的研發風險，使其適用於中低收入國家需要或希望使用此類產品來避免意外懷孕的女性，並能被她們接受。

A $3.6 million dollar installment under a November 2024 grant agreement is anticipated to be received later this month. Together, these programs demonstrate our ability to leverage strategic collaborations, including with public funders and foundations to advance a portfolio that addresses meaningful gaps in women's health while maintaining disciplined capital allocation.

根據2024年11月簽署的撥款協議，預計本月稍後收到360萬美元的款項。這些計畫共同展現了我們利用策略合作（包括與公共資助機構和基金會的合作）的能力，從而推進一系列旨在解決女性健康領域重大缺口、同時保持穩健資金配置的計畫。

I'm now going to turn it back over to our Chief Accounting Officer Mardee to review the financial results for the recently completed quarter.

現在我將把這項工作交還給我們的首席會計官瑪迪，讓她審查最近一個季度的財務表現。

Thanks Sabrina and thanks everyone for joining us today. I would now like to summarize Dare's financial results for the quarter ended September 30, 2025, which I will refer to as the third quarter. We ended the quarter with approximately $23 million in cash and cash equivalents and working capital of approximately $3.8 million.

謝謝Sabrina，也謝謝各位今天蒞臨。現在，我想總結一下Dare截至2025年9月30日的季度財務業績，我將其稱為第三季。該季末，我們持有約2,300萬美元的現金及現金等價物，以及約380萬美元的營運資金。

During the third quarter, we received approximately $18.7 million in net proceeds from sales of our common stock and a total of $7.3 million in grant payments. This additional capital strengthened our balance sheet, enhancing our ability to execute on our dual path strategy.

第三季度，我們透過出售普通股獲得約1,870萬美元的淨收益，並收到總計730萬美元的補助金。這些額外資金增強了我們的資產負債表，提升了我們執行雙軌制策略的能力。

G&A expenses were $2.5 million compared to $2 million in Q3 2024. The year over year change was primarily due to increases in professional services expense and commercial readiness expenses driven by execution against our expanded business strategy.

一般及行政費用為 250 萬美元，而 2024 年第三季為 200 萬美元。年比變化的主要原因是專業服務費用和商業準備費用增加，這是由於我們擴大業務策略的實施所致。

R&D expenses were $1.2 million compared to $2.7 million in Q3 2024, a 56% decrease, primarily due to an increase in contra R&D expenses or reductions to R&D expenses that we recognized due to non-dilutive funding. As well as decreases in manufacturing costs related to Ovaprene and in personnel costs.

研發費用為120萬美元，而2024年第三季為270萬美元，年減56%，主要原因是研發費用抵減項增加或因非稀釋性融資而確認的研發費用減少，以及與Ovaprene相關的製造成本和人員成本的下降。

Partially offset by increases in costs related to development activities for other clinical and preclinical stage R&D programs, including DARE-HPV and DARE-LARC1, Sildenafil cream, 3.6%, Dare to Play Sildenafil cream, and DARE-PTB1.

部分被其他臨床和臨床前階段研發項目（包括 DARE-HPV 和 DARE-LARC1、3.6% 西地那非乳膏、Dare to Play 西地那非乳膏和 DARE-PTB1）的開發活動相關成本增加所抵消。

We encourage investors to review the more detailed discussion of our financial statements, our financial condition, liquidity, capital resources, and risk factors in our Form 10-Q for the quarter ended September 30, 2025 filed today.

我們鼓勵投資者查閱我們今天提交的截至 2025 年 9 月 30 日的季度 10-Q 表格，其中詳細討論了我們的財務報表、財務狀況、流動性、資本資源和風險因素。

I would now like to turn the call back to Sabrina.

現在我想把電話轉回薩布麗娜。

Thank you, Mardee and I'd actually like to turn the call over to the operator for a Q&A.

謝謝你，瑪迪，我其實想把電話轉給接線生進行問答環節。

Thank you, Sabrina. (Operator Instructions)

謝謝你，薩布麗娜。 （操作說明）

Catherine Novack, Jones.

凱瑟琳·諾瓦克，瓊斯。

Hi, good afternoon. Thanks for taking our questions. So the first one for me is if you can comment on your thoughts on FDA's recent reversal and guidance on hormone replacement therapy and me menopause, what feedback have you gotten, if any, since that decision was announced and what can you do to fill the treatment gap in the near term?

您好，下午好。感謝您回答我們的問題。我的第一個問題是，您能否談談您對FDA最近關於荷爾蒙替代療法和更年期治療的政策逆轉和指導意見的看法？自從該決定宣布以來，您收到了哪些回饋？您認為短期內可以採取哪些措施來填補治療空白？

Love that question. Thank you for asking. And we are thrilled, I'll start by saying we are thrilled. We were thrilled to see that change. We as a company, we're developing Dare to Reclaim, which is our hormone, menopause hormone therapy, vaginal ring that has estradiol and progesterone together in a single ring, once a month product and delivered non orally, which, is what the Menopause Society recommends and both of those hormones together for women without a uterus.

這個問題我很喜歡，謝謝你的提問。我們非常激動，首先我要說，我們真的非常激動。看到這樣的改變，我們感到無比欣慰。我們公司正在研發「敢於重塑自我」（Dare to Reclaim）這款產品，它是一種更年期激素療法，採用陰道環的形式，將雌二醇和孕酮合二為一，每月使用一次，無需口服。這正是更年期協會推薦的療法，尤其適合沒有子宮的女性。

And, as such, we've been attending the Menopause Society for years since we started this company and have been working on that program and have watched the presentations year over year over year. Really that have debunked the scientific research that has debunked some of the outcomes of the 2002 Women's Health Initiative that led to the initial black box warning.

因此，自從公司成立以來，我們多年來一直參加更年期協會的活動，並參與該項目，年復一年地觀看他們的演講。這些演講確實駁斥了2002年婦女健康倡議的部分研究結果，而這些結果正是導致最初發布黑框警告的原因。

And new data that are citing the potential benefits, right, of hormone therapy, where the recommendations continue to be, if you have a uterus, both hormones together, progesterone for endometrial protection, estradiol.

新的數據顯示了荷爾蒙療法的潛在益處，對吧？目前的建議仍然是，如果你有子宮，同時使用兩種荷爾蒙：黃體素用於保護子宮內膜，雌二醇。

For the effectiveness, ideally micronized bioidentical non-oral forms, but demonstrating improvements in recent studies that have shown improvements in bone health, in brain health, and in cardiovascular health. So the field -- the scientific field has moved forward. The clinicians have moved forward, but sadly they have not had trusted solutions.

就療效而言，理想的非口服生物同源微粉化製劑是最佳選擇，但近期研究表明，此類製劑在改善骨骼健康、大腦健康和心血管健康方面均有所進步。因此，科學領域取得了進展，臨床醫生也取得了進展，但遺憾的是，他們尚未找到值得信賴的解決方案。

For menopause hormone therapy, and the products that are available have, that are FDA approved. There's an oral form approved with the two hormones together, and then there are single product, patches like estradiol patches or, vaginal products and then progesterone that one could take separately.

更年期荷爾蒙療法目前有多種產品，均已獲得FDA批准。其中一種是口服製劑，同時含有兩種荷爾蒙；此外還有單方製劑，例如雌二醇貼片或陰道製劑；以及可單獨服用的黃體素。

But all those estrogen products have that black box warning that creates fear, frankly, for women in taking those products and, In many cases, really unwarranted fear given what the newer data and the newer interpretation of the [2000 and 2] findings say. So that's a long way of saying we are so happy.

但所有這些雌激素產品都有黑框警告，坦白說，這會讓服用這些產品的女性感到恐懼，而且在很多情況下，鑑於更新的數據以及對[2000 年和 2002 年]研究結果的更新解讀，這種恐懼其實是沒有必要的。所以，說了這麼多，其實就是想表達我們非常高興。

I can tell you I'm at, I'm currently today at the International Society for the Study of Women's Sexual Health, which is a sexual health focused conference, but healthcare providers here who know we are working on our hormone therapy, vaginal ring have come by to make sure to see us and tell us how happy they are about the outcome and how hopeful they are in terms of what they think that will mean for our product when it's available and women, having access to something like that.

我可以告訴大家，我今天正在參加國際女性性健康研究協會的會議，這是一個以性健康為重點的會議。這裡的醫療保健提供者知道我們正在研發荷爾蒙療法和陰道環，他們特意過來和我們見面，告訴我們他們對研究結果感到非常高興，並對我們產品上市後能為女性帶來的影響充滿希望。

So we are really happy to see the FDA and we're happy to see, FDA commissioner, really talking about this, right, and elevating this issue and doing something that will make a product, available to more women that can benefit from it.

所以我們很高興看到美國食品藥物管理局（FDA）以及FDA局長認真討論這個問題，並提升這個問題的關注度，採取一些措施，使更多能夠從中受益的女性能夠獲得該產品。

Got it. And is this, you mentioned it will be available early 2027. Will that also be. Through a compounder or is there a path to make this an FDA? .

明白了。您提到這款產品將於2027年初上市。屆時也是透過配藥廠銷售，還是需要獲得FDA批准？

Both, so we're, when I talk about 2027, we're talking specifically about that opportunity to pursue a similar strategy like we're doing with Dare to Play and Sildenafil cream where we partner with a third-party 503B outsourcing facility, in this case that would have the capabilities to manufacture a product of this nature.

兩者兼有，所以當我談到 2027 年時，我們具體指的是有機會採取與 Dare to Play 和 Sildenafil 乳膏類似的策略，即與第三方 503B 外包機構合作，在這種情況下，該機構將有能力生產此類產品。

We are continuing our process with the FDA, we, you may recall that we had announced, a while ago now that the FDA was, aligned that only one phase 3 trial would be required to support the registration for this product.

我們正在繼續與 FDA 進行溝通。您可能還記得，我們​​之前宣布過，FDA 同意只需要一項 3 期試驗即可支持該產品的註冊。

But we had not yet filed the NDA, the [IND] or continued with that program where we're waiting to work out some additional details on the phase redesign and requirements with the FDA. So that process is ongoing and certainly as we have updates, we will announce those updates, but we do see that there is an opportunity that we can pursue similarly to get this product into the hands of women.

但我們尚未提交新藥申請（NDA）或研究性新藥申請（IND），也未繼續推進該項目，目前我們正在與FDA商討階段性調整和相關要求的更多細節。因此，該流程仍在進行中，一旦有任何進展，我們一定會及時公佈。但我們確實看到了一個機會，可以透過類似的途徑，讓更多女性能夠用上這款產品。

Faster, right, and get that access for this evidence-based product, while that FDA process is still ongoing.

更快，對吧？趁著FDA審批流程還在進行中，盡快讓這款有科學根據的產品獲得市場進入。

Got it. And now just thinking about now that you have. A decent amount of cash runway. How do you think about prioritizing the R&D programs that you are, that are in clinical development for FDA approval?

明白了。現在你們有了相當可觀的現金儲備，你們打算如何安排那些正在進行臨床開發以獲得FDA批准的研發項目的優先順序呢？

Yeah, it's a great question. So we're really prioritizing right now, if you think about our our activities, it's definitely everything we've been talking about Dare to Play, Sildenafil cream, and getting that out there. Some of these opportunities that we've been talking about, just like the Dare to Reclaim, estradiol, progesterone, vaginal ring, the Dare to Restore vaginal probiotics, getting those to market.

是的，這是一個很好的問題。所以，我們現在的優先事項，如果你看看我們正在進行的活動，你會發現絕對是我們一直在討論的「敢於嘗試」（Dare to Play）計畫、西地那非乳膏，以及盡快將它們推向市場。我們一直在討論的一些機會，例如「敢於重塑」（Dare to Reclaim）計畫、雌二醇、孕酮、陰道環、「敢於修復」（Dare to Restore）陰道益生菌，也正在努力將它們推向市場。

I talked about a number of our grant-funded, fully or partially grant-funded programs. Those are definitely a priority. So I'm talking about Ovaprene, which is in phase 3, the DARE-HPV product, which is, we're working towards filing that IND and getting into phase 2. That's what that ARPA-H and NIH funding supports and as well as DARE-LARC1, which is pre-clinical, and now also getting to do a lot more activities on what we call [NHC], that non-hormonal contraceptive, technology.

我談到了我們一些由撥款資助的項目，包括全部或部分撥款資助的項目。這些項目絕對是我們的優先事項。例如，Ovaprene 目前處於三期臨床試驗階段；DARE-HPV 產品，我們正在努力提交新藥臨床試驗申請（IND）並進入二期臨床試驗。 ARPA-H 和 NIH 的撥款支持了這些計畫；此外，DARE-LARC1 目前處於臨床前階段；我們現在也正在進行更多關於我們稱之為 [NHC] 的非荷爾蒙避孕技術的研究工作。

So those are definitely a priority. And then as we think about, the programs that require, Additional, right? R&D investment, we're really looking those -- looking at those one on one on one by one, and we're really trying to prioritize those opportunities where we have a very clear path to market, so that means we've got that regulatory roadmap.

所以這些肯定是優先事項。然後，當我們考慮那些需要額外研發投入的項目時，我們正在逐一審視這些項目，並努力優先考慮那些擁有非常清晰的市場路徑的機會，這意味著我們已經有了相應的監管路線圖。

Outlined with the FDA, which remember for us it is a process. These are all first in category products, so they all take discussion with the FDA, but we will prioritize those opportunities as you might expect, right, for shareholders, the ones where we have a clear path forward, the market opportunity is clear robust, and we can clearly execute against that.

我們已經與FDA溝通過，請記住，這對我們來說是一個流程。這些都是同類首創產品，因此都需要與FDA進行討論，但正如您所預期的，我們會優先考慮那些我們擁有清晰發展路徑、市場機會明確且前景廣闊，並且我們能夠有效執行的項目，這對股東來說至關重要。

So more to follow, but I would say right now big focus on these programs that have, grant funding that has really helped propelling them forward and, Ovaprene and DARE-HPV are later stage programs in that regard as well.

後續還有更多進展，但我想說，目前重點是那些獲得撥款資助的項目，這些資助確實幫助推動了它們的進展，而 Ovaprene 和 DARE-HPV 在這方面也是後期項目。

Got it, thanks, Sabrina. Thanks for taking our questions.

明白了，謝謝你，薩布麗娜。謝謝你回答我們的問題。

Kemp Dolliver from Brookline Capital Markets.

來自布魯克林資本市場的肯普·多利弗。

Great, thank you. I have two separate and different questions.

太好了，謝謝。我還有兩個不同的問題。

First with regard to Dare to Play, you have the partnership with Rosy Wellness, and I'm wondering what other similar partnerships you have in mind to essentially increase awareness because I think, There are about 250,000 people using Rosy Wellness at least based on what they've disclosed, and it sounds like you need to have broader partnerships to really tap this market.

首先，關於「敢於玩樂」項目，你們與Rosy Wellness建立了合作關係。我想知道你們還有哪些類似的合作計畫來提高知名度，因為根據Rosy Wellness揭露的數據，至少有25萬人使用他們的產品。聽起來你們需要更廣泛的合作才能真正開拓這個市場。

Yeah, so there are it's a great question. So there are a few different things that we're looking at as we think about the Dare to Play product and as we think about awareness, right? So one pillar of that is around clinician awareness, provider awareness, that is has been pretty easy to tap into, quite frankly, just because, one is timing, kind of great time of year to be doing this.

是的，這是一個很好的問題。我們在考慮「敢於嘗試」產品以及提高公眾意識時，會關注幾個不同的方面，對吧？其中一個支柱是提高臨床醫生和醫療服務提供者的意識，坦白說，這方面很容易做到，原因有二：一是時機，現在是開展這項工作的絕佳時機。

It's the time of year where the providers that are most relevant to a product like this are having all their meetings. Things menopause society, sexual health meeting, nurse practitioners and women's health, we're at all of those, plus the webinar and events we're doing with the thought leaders. So that really helps us get in front of a lot of the providers that are important.

每年這個時候，與我們產品最相關的醫療服務提供者都會召開各種會議。例如更年期協會、性健康會議、執業護理師會議和女性健康會議，我們都會參加，此外，我們還會與產業領袖一起舉辦網路研討會和活動。這確實有助於我們接觸到許多重要的醫療服務提供者。

One of the other pillars is awareness in terms of really ease of prescribing, right, and having a health portal and an online health portal that makes it very easy for someone who has a prescription. To get their prescription, as well as people that maybe don't have a prescription yet and need access to telehealth, and we're really doing that through our relationship with [Midvantix].

另一個支柱是提高人們對處方便捷性的認識，對吧？我們需要一個健康入口網站和一個線上健康入口網站，讓已經持有處方的人能夠輕鬆取得處方，同時也為那些可能還沒有處方但需要遠距醫療服務的人提供幫助。我們正在透過與[Midvantix]的合作來實現這一點。

So Midvantix has the has the ability to take in those prescriptions to manage that prescription inflow, manage the cash pay piece, very straightforward portal that will be available right as we start fulfilling prescriptions in December for people.

因此，Midvantix 能夠接收這些處方，管理處方流入，管理現金支付部分，這是一個非常簡單的入口網站，當我們在 12 月開始為人們配藥時，網站就會上線。

To get, but also a connectivity with the telehealth resource for those women that don't have that, and then we're supplementing all of that, then there will be additional, like we, there are additional places right where the product's going to be showing up in partnerships we're really prioritizing those for when we have availability in all 50 states and we have that full availability across the country.

為了獲得這些服務，我們也為那些沒有遠距醫療資源的女性提供連接，然後我們會補充所有這些服務，然後還會有其他方面，例如，我們的產品將在其他合作管道中出現，我們正在優先考慮這些管道，以便在所有 50 個州都提供產品，並在全國範圍內全面覆蓋。

But I would say the other thing that is also really helpful in the near term is. Using online advertising opportunities, right think platforms like Facebook and Instagram and other social media tools like podcasts, appropriate sexual health influencers that have a large community of followers. So you will also start seeing Google Ads where relevant. You'll also start seeing, more and more of that as the product becomes available and particularly as we go into the new year.

但我認為，近期內另一個非常有幫助的方法是利用網路廣告機會，例如Facebook、Instagram等主流平台，以及其他社群媒體工具，例如播客，還有那些擁有大量粉絲的性健康領域意見領袖。你也會開始在相關的地方看到Google廣告。隨著產品上市，尤其是在新的一年裡，你會看到越來越多的這類廣告。

So those are the kind of things, to be looking for and then once we have that availability across the country, then it's a great opportunity for some of these additional types of, relationships where right where it can be available via their platforms as well.

所以這些都是我們需要關注的事情，一旦我們在全國範圍內實現了這一點，那麼對於其他類型的合作關係來說，這將是一個絕佳的機會，因為這些合作關係也可以透過他們的平台來實現。

So stay tuned, more to follow, right now we've really been prioritizing [clinician], right making sure the healthcare providers that see these women today are well aware of this product and know exactly how to prescribe it, that they have all the tools that they need, and then also making sure that that patient experience in terms of that online portal through Midvantix is seamless and a wonderful experience.

敬請期待，後續還有更多內容。目前，我們一直優先考慮[臨床醫生]，確保今天接診這些女性的醫療保健提供者充分了解該產品，並確切地知道如何開處方，確保他們擁有所需的所有工具，同時還要確保患者通過 Midvantix 在線門戶網站獲得的體驗流暢且美好。

Great, that's very helpful. The second question is the ATM and whether there's additional capacity left on it.

太好了，這很有幫助。第二個問題是關於自動櫃員機，看看裡面是否還有剩餘的現金。

Yeah, so we are, [Dare] is subject to baby shelf. So for those who aren't familiar, it has to do with what our market cap is, and that does limit, how much is available under a resource, like the ATM. And so, baby shelf limitations. I think you can kind of do the math with the amount that Mardee, talked about that came in during the last quarter. We are limited therefore, with baby shelf restrictions in terms of being able to actually use an ATM today.

是的，所以[Dare]確實受到“嬰兒貨架”的限制。對於不太了解的人來說，這和我們的市值有關，市值會限制某些資源（如ATM）的可用數量。這就是所謂的「嬰兒貨架」限制。我想你可以根據Mardee提到的上個季度的收入來估算一下。因此，由於「嬰兒貨架」的限制，我們今天實際使用ATM的能力是有限的。

Super, thank You.

太好了，謝謝。

Thank you. Great Questions.

謝謝。問得好。

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

問答環節到此結束。現在我將電話交還給薩布麗娜·馬圖奇·約翰遜，請她補充或作總結發言。

Great. Well, thank you everyone for joining us this afternoon and, hopefully, you're coming away with a good understanding that we are executing a multi-pronged value creation strategy. We're preparing for revenue generation via Dare to Play and Sildenafil cream starting in the fourth quarter and advancing a rich clinical pipeline and doing so with a fiscal discipline and access to significant non-dilutive capital.

太好了。感謝各位今天下午蒞臨，希望大家能充分理解我們正在實施的多管齊下的價值創造策略。我們正準備從第四季開始透過「敢於嘗試」（Dare to Play）和西地那非乳膏（Sildenafil cream）實現營收成長，同時推進豐富的臨床研發管線，並始終秉持嚴謹的財務紀律，同時擁有充足的非稀釋性資本。

And with four commercially available solutions for women on the horizon, one expected to begin generating revenue in this fourth quarter, and multiple product candidates advancing in clinical and pre-clinical development. We believe it's a compelling time for investors to take a fresh look at Dare.

隨著四款面向女性的商用解決方案即將上市，其中一款預計將於第四季度開始產生收益，以及多款候選產品正在推進臨床和臨床前開發，我們認為現在是投資者重新審視 Dare 的絕佳時機。

Dare is uniquely positioned to cut through the noise. In today's biopharma landscape, companies with relatively low-risk assets, differentiated science, and a clear path to near-term revenue are in rare supply, and we believe Dare, is one of those rare opportunities.

Dare公司擁有獨特的優勢，能夠脫穎而出。在當今的生物製藥領域，擁有風險相對較低的資產、差異化的科學技術以及清晰的近期盈利路徑的公司寥寥無幾，而我們相信Dare公司正是這樣一家難得的投資機會。

And women's health is a market that has long been underfunded and underserved, and therefore that means it is ripe for value creation. With our recently expanded business strategy, we're well positioned to bring multiple products to market efficiently via both prescription and nonprescription channels and generate meaningful return for stakeholders.

女性健康市場長期以來資金不足、服務欠缺，因此蘊藏著巨大的價值創造潛力。憑藉我們近期拓展的業務策略，我們已做好充分準備，透過處方藥和非處方藥管道高效地將多種產品推向市場，並為利害關係人創造可觀的回報。

We believe our nimble model enables us to commercialize through 503B compounding, pursue FDA approvals, and launch branded consumer health solutions all in parallel. And we believe the coming weeks will represent a historic moment for Dare and for women seeking new options, and we're proud to be leading the science, collaboration and purpose and are excited to begin making Dare to Play available through the 503B channel, which is on track for December.

我們相信，我們靈活的模式能夠讓我們透過503B計畫進行商業化，同時推進FDA審批，並推出自有品牌的消費者健康解決方案。我們相信，未來幾週對於Dare以及尋求新選擇的女性而言，都將是一個歷史性的時刻。我們很自豪能夠引領科學、合作與目標的實現，並期待Dare to Play能夠透過503B管道上市，預計12月按計畫啟動。

We expect initial revenue recognition in the fourth quarter this year and believe our commercial portfolio will serve as a robust foundation, providing a path to profitability. So, I thank our team, our partners, and our shareholders for all the continued confidence and support.

我們預計今年第四季確認首筆收入，並相信我們的商業組合將構成堅實的基礎，為實現盈利鋪平道路。因此，我衷心感謝我們的團隊、合作夥伴和股東們一直以來的信任與支持。

Thank you so much.

太感謝了。

This concludes today's conference call. You may now disconnect.

今天的電話會議到此結束。您可以掛斷電話了。