Dare Bioscience Inc (DARE) 2026 Q2 法說會逐字稿

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使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Hello, and welcome to the Daré Bioscience second quarter 2026 corporate update conference call and webcast. (Operator Instructions) Note that this webcast is being recorded at the company’s request, and a replay will be made available on the company’s website following the end of the event. Joining us today from Daré Bioscience are Sabrina Martucci Johnson, President and Chief Executive Officer, and MarDee Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton, please proceed.

    您好,歡迎參加 Daré Bioscience 2026 年第二季公司最新進展電話會議與網路直播。(接線員指示)請注意,本次網路直播係應公司要求進行錄製,活動結束後將於公司網站提供重播。今天與會的 Daré Bioscience 代表包括總裁兼執行長 Sabrina Martucci Johnson,以及首席會計長 MarDee Haring-Layton。Haring-Layton 女士,請開始。

  • Mardee Haring-layton - Chief Accounting Officer

    Mardee Haring-layton - Chief Accounting Officer

  • Good afternoon and welcome. Today, we will review our financial results, provide updates on our commercial products and clinical pipeline, and discuss the continued execution of our expanded business strategy. 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.

    各位下午好,歡迎各位。今天我們將回顧財務結果,更新商業化產品與臨床研發管線的進展,並討論我們擴大後之商業策略的持續執行。該策略包含雙軌並行的方法:一方面透過 503B 藥品調劑(compounding)將自有配方商業化,同時推進 FDA 核准;另一方面,將部分解決方案發展為不需處方的品牌化消費者健康產品。

  • In all cases, our goal is to bring innovative women’s health solutions to market as efficiently and quickly as possible. 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 actual statements of historical fact should be considered forward-looking statements.

    在所有情況下,我們的目標都是以最高效率、最快速度將創新的女性健康解決方案推向市場。我也要提醒各位,今天的討論將包含符合聯邦證券法所定義的前瞻性陳述,並依據 1995 年《私人證券訴訟改革法》(Private Securities Litigation Reform Act of 1995)的安全港條款作出。本次電話會議中任何非屬歷史事實的陳述,均應視為前瞻性陳述。

  • 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.

    由於已知與未知的風險與不確定性,實際結果或事件可能與這些陳述所預期或暗示者存在重大差異。您不應過度依賴前瞻性陳述。

  • Forward-looking statements are qualified in their entirety by the cautionary statements in the company’s SEC filings, including our quarterly report on Form 10-Q for the quarter ended June 30, 2026, which was filed today, and our annual report on Form 10-K for the year ended December 31, 2025.

    前瞻性陳述在其整體上均受公司向 SEC 提交文件中的警示性聲明所限制,包括我們截至 2026 年 6 月 30 日止季度的 10-Q 季度報告(已於今日提交),以及截至 2025 年 12 月 31 日止年度的 10-K 年度報告。

  • Please note that the content of this call includes time-sensitive information that is current only as of today, August 13, 2026. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

    另請注意,本次電話會議內容包含具時效性的資訊,僅截至今日(2026 年 8 月 13 日)為止為最新。除法律要求外,Daré 不承擔於本次會議後更新任何前瞻性陳述以反映新資訊或新發展之義務。

  • I would also like to point out that when we use the term 503B compounding during this discussion, we are referring to compounding drug products by outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act using bulk drug substances on the FDA’s interim Category 1 list.

    我也要指出,當我們在本次討論中使用「503B 調劑(503B compounding)」一詞時,係指由依《聯邦食品、藥品與化妝品法》(Federal Food, Drug, and Cosmetic Act)第 503B 條註冊之外包設施(outsourcing facilities),使用 FDA 臨時第 1 類(Category 1)清單上的散裝藥物原料(bulk drug substances)所進行的藥品調劑。

  • I would now like to turn the call over to Sabrina.

    現在我想把電話會議交給 Sabrina。

  • Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

    Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

  • Thank you, Marnie, and good afternoon, everyone, and thank you for joining us. For more than 10 years, Daré has been building towards this moment. We built Daré on a simple conviction. Women’s health is an investment-grade category, not a niche, not a side project. A category worth building, funding, and holding accountable for delivering the healthcare options women deserve.

    謝謝你,Marnie。各位下午好,也感謝各位加入我們。十多年來,Daré 一直在為此刻努力。我們以一個簡單的信念打造 Daré:女性健康是一個具投資等級的領域,不是利基市場,也不是附帶專案;這是一個值得投入建設、資金支持,並以問責方式確保能提供女性應得醫療選擇的領域。

  • Every asset we developed, every trial we ran, every grant we secured, every collaboration we’ve negotiated, all of it has been directed towards this one purpose, closing the gap between promising science and real-world solutions for women. Over the past few months, that strategy crossed an important threshold. We did not stop being a science-driven development company. We added something new, commercial execution. That distinction matters.

    我們開發的每一項資產、進行的每一項試驗、取得的每一筆補助、談成的每一項合作,全部都指向同一個目的:縮小有前景的科學與女性在真實世界可取得之解決方案之間的落差。過去幾個月,這項策略跨越了一個重要門檻。我們並未停止作為以科學驅動的研發公司;我們新增了一項能力:商業化執行。這個差異很重要。

  • Daré was built not only to develop differentiated solutions for women’s health, but to bring those solutions directly to the women who need them. With our first product that we are commercializing directly now on the market and a second approaching prescription dispensing, that vision is becoming a commercial reality. In June, we launched Flora Sync LF5, the first product in our DARE to RESTORE line.

    Daré 的成立不僅是為了開發具差異化的女性健康解決方案,更是為了將這些解決方案直接帶給需要的女性。隨著我們第一個由公司直接商業化的產品已上市、第二個產品也即將進入處方配藥(prescription dispensing)階段,這個願景正逐步成為商業現實。6 月,我們推出 Flora Sync LF5,這是我們 DARE to RESTORE 產品線的第一個產品。

  • It was Daré’s first product to enter the market directly via Daré and a milestone marking a new chapter for our company. At the same time, we continued advancing DARE to PLAY sildenafil cream toward prescription dispensing, which we are targeting to begin this quarter.

    這是 Daré 首次透過 Daré 直接進入市場的產品,也是標誌公司邁入新篇章的重要里程碑。同時,我們持續推進 DARE to PLAY 西地那非(sildenafil)乳膏朝處方配藥邁進,目標是在本季開始。

  • One product is launched and a second product is approaching dispensing, and a commercial platform is now live, and that is what makes this quarter different. We are still in the early stages of commercialization, and our priority is disciplined execution.

    一項產品已上市、第二項產品即將開始配藥,而商業化平台也已上線,這正是本季與以往不同之處。我們仍處於商業化的早期階段,我們的首要任務是有紀律地執行。

  • The infrastructure, the relationships, and the capabilities we are putting in place today are designed to support efficient, repeatable growth as our commercial portfolio expands. The transition is real. Daré now has products moving from pipeline into the market and a strategy designed so that each launch strengthens that platform for the next.

    我們今天正在建立的基礎設施、合作關係與能力,旨在隨著商業產品組合擴大,支援高效率、可複製的成長。這項轉型是真實的。Daré 現在已有產品從研發管線走向市場,且我們的策略設計使得每一次上市都能強化平台,為下一次上市奠定更好的基礎。

  • Let me begin with Flora Sync LF5. Flora Sync LF5 is a non-hormonal probiotic vaginal capsule designed to support vaginal microbiome balance, moisture, and comfort. Available without a prescription, it is formulated with a form of Lactobacillus fermentum LF5, a proprietary strain backed by more than 30 years of probiotic research.

    我先從 Flora Sync LF5 開始。Flora Sync LF5 是一款非荷爾蒙的益生菌陰道膠囊,旨在支持陰道微生物相(vaginal microbiome)的平衡、保濕與舒適。該產品無需處方即可取得,其配方含有 Lactobacillus fermentum LF5 的一種形式,這是一株專有菌株,並有超過 30 年的益生菌研究作為支持。

  • What differentiates Flora Sync LF5 is the science behind it. Flora Sync LF5 was evaluated in a randomized clinical study involving 100 women, with results published in a peer-reviewed journal. That level of product-specific clinical research is unusual in a category where consumers frequently encounter products with limited supporting evidence.

    Flora Sync LF5 的差異化在於其背後的科學基礎。Flora Sync LF5 曾在一項隨機臨床研究中評估,研究納入 100 名女性,結果並已發表於同儕審查期刊。對於一個消費者經常遇到支持證據有限產品的品類而言,如此針對特定產品的臨床研究水準並不常見。

  • We believe this creates a meaningful commercial opportunity. One survey found that approximately 65% of women aged 18 to 65 feel insecure about their vaginal scent. Flora Sync LF5 does not need to reach the entire market to become a meaningful product for Daré. Even modest penetration could generate significant commercial value, particularly when considering the potential for repeat use.

    我們相信這帶來了具意義的商業機會。一項調查發現,約有 65% 的 18 至 65 歲女性對其陰道氣味感到不安。Flora Sync LF5 不需要觸及整個市場,就能成為 Daré 的重要產品。即使是適度的市場滲透,也可能帶來可觀的商業價值,特別是考量到重複使用的潛力。

  • Flora Sync LF5 was priced with accessibility and ongoing use in mind. We believe it has potential to become part of a woman’s regular vaginal care routine, creating an opportunity to drive initial trial, encourage recurring demand, and build lasting consumer relationships.

    Flora Sync LF5 的定價考量了可負擔性與持續使用。我們相信它有潛力成為女性日常陰道護理的一部分,從而創造推動首次試用、促進持續性需求並建立長期消費者關係的機會。

  • Let me now turn to DARE to PLAY sildenafil cream, our proprietary topical sildenafil cream designed for women, which addresses a large and deeply underserved area of women’s health. An estimated 20 million women in the US experience symptoms of low or no sexual arousal. Yet there is no currently FDA-approved treatment specifically indicated for female sexual arousal disorder.

    接著談 DARE to PLAY 西地那非乳膏。我們的專有外用西地那非乳膏是為女性設計,聚焦於女性健康中一個龐大且長期被忽視的領域。據估計,美國約有 2,000 萬名女性出現性喚起低下或缺乏的症狀。然而,目前尚無任何 FDA 核准、且明確適應症為女性性喚起障礙(female sexual arousal disorder)的治療。

  • Women have waited far too long for solutions developed around their physiology, experiences, and needs. In clinical studies of our formulation, we observed increased genital blood flow and improvements in arousal sensations.

    女性等待以其生理、經驗與需求為核心所開發的解決方案,已經太久了。在我們配方的臨床研究中,我們觀察到生殖器血流增加,以及喚起感受的改善。

  • The formulation was well-tolerated by both users and their partners in our Phase IIb study, and no serious safety concerns were reported. By improving physical arousal sensation, DARE to PLAY sildenafil cream is designed to support a more positive and responsive sexual experience.

    在我們的第 IIb 期研究中,該配方對使用者及其伴侶均具有良好耐受性,且未報告任何嚴重的安全性疑慮。透過改善身體喚起的感受,DARE to PLAY 西地那非乳膏旨在支持更正向、反應更佳的性體驗。

  • At a price of $99 per tube, which provides for about 10 uses, the estimated addressable population of 20 million women represents a total market opportunity of approximately $2 billion. Even modest market penetration could create meaningful commercial value in an area with limited female-specific treatment options.

    以每條 99 美元的價格計算(約可使用 10 次),估計可觸及的 2,000 萬名女性族群代表約 20 億美元的整體市場機會。即使是適度的市場滲透,也可能在女性專屬治療選項有限的領域創造具意義的商業價值。

  • Initially, we intended to make DARE to PLAY sildenafil cream available by prescription as a 503B compounded product while continuing to pursue the 505(b)(2) regulatory pathway toward potential FDA approval. You might ask, why the dual-path regulatory strategy? The reason is that while the compounded pathway offers a capital-efficient way to enter the market, FDA approval would represent an opportunity for women to have an FDA-approved option, as men do.

    起初,我們原本打算在持續推進 505(b)(2) 法規途徑、以期獲得 FDA 潛在核准的同時,先以 503B 複方產品的處方形式提供 DARE to PLAY 西地那非乳膏。你可能會問,為什麼要採取雙軌法規策略?原因在於,複方途徑提供了一種資本效率較高的方式進入市場,而 FDA 核准則代表女性也能像男性一樣,擁有一個 FDA 核准的選項。

  • An FDA-approved product could provide greater confidence among patients and prescribers and support broader commercial adoption because FDA-approved products can be administered as treatments and considered for coverage by payers. It could also strengthen our competitive position to create a more durable and valuable commercial franchise.

    一項獲 FDA 核准的產品可在患者與處方醫師之間建立更高的信心,並支持更廣泛的商業採用,因為 FDA 核准產品可作為治療方式使用,且可被付款方納入給付評估。它也能強化我們的競爭地位,打造更具持久性與價值的商業特許經營。

  • And in this way, the compounded product can provide an efficient path to early market entry while pursuing FDA approval is designed to unlock the potential of the product as the potential first FDA-approved product to treat female sexual arousal disorder. Although DARE to PLAY sildenafil cream is not yet dispensing, interested customers can already begin the simple process of obtaining a prescription.

    透過這種方式,複方產品可提供一條高效率的早期上市路徑;而追求 FDA 核准則旨在釋放該產品的潛力,使其有機會成為首個用於治療女性性喚起障礙的 FDA 核准產品。雖然 DARE to PLAY 西地那非乳膏尚未開始配藥,但有興趣的客戶已可開始進行取得處方的簡單流程。

  • While it’s still early, I’m encouraged by what we’re seeing in terms of geography of prescriptions being written, a healthy split between office providers and telehealth, and repeat prescriptions from providers. Dispensing is targeted to begin this quarter.

    雖然仍處於早期階段,但就處方開立的地理分布、診所端醫療提供者與遠距醫療之間的健康比例分布,以及醫療提供者的重複開立處方而言,我對目前看到的情況感到鼓舞。配藥預計於本季開始。

  • Let’s now turn to our commercial strategy. It begins with providers. OBGYNs and women’s health specialists are trusted voices, and their conviction can drive both product awareness and appropriate patient use. Digital marketing expands that reach by educating women directly and helping us identify the messages and audience that converts most efficiently. Telehealth creates convenient access and national reach, and the DARE Health Hub brings education, product access, fulfillment, and ongoing engagement into one central destination.

    接下來談談我們的商業策略。策略起點是醫療提供者。婦產科醫師(OBGYN)與女性健康專科是值得信賴的聲音,他們的信念能同時推動產品認知與適當的患者使用。數位行銷透過直接教育女性來擴大觸及,並協助我們辨識轉換效率最高的訊息與受眾。遠距醫療提供便利的取得途徑與全國性觸及,而 DARE Health Hub 則把教育、產品取得、履約交付與持續互動整合到一個核心目的地。

  • Our recently announced collaboration with MyMenopauseRx further expands that ecosystem through an established women’s health telehealth platform. Additionally, this collaboration highlights how we plan to engage with other telehealth platforms, where women can receive a prescription for DARE to PLAY sildenafil cream. The DARE Health Hub serves as the foundation of our commercial strategy.

    我們近期宣布與 MyMenopauseRx 的合作,透過一個既有的女性健康遠距醫療平台,進一步擴大該生態系。此外,這項合作也凸顯我們計畫如何與其他遠距醫療平台互動,讓女性可取得 DARE to PLAY 西地那非乳膏的處方。DARE Health Hub 是我們商業策略的基礎。

  • For patients, the DARE Health Hub creates a central destination where women can learn about our products, understand which solutions may be relevant to their needs, and navigate the path to access. It brings together education, product discovery, telehealth connectivity, fulfillment, and ongoing engagement in a convenient and cohesive experience.

    對患者而言,DARE Health Hub 打造一個核心目的地,讓女性能了解我們的產品、理解哪些解決方案可能與其需求相關,並引導其完成取得途徑。它把教育、產品探索、遠距醫療連結、履約交付與持續互動整合成便利且一致的體驗。

  • For Daré, the DARE Health Hub creates a direct connection with the women we serve. It gives us greater visibility into the full customer journey, from initial awareness and product evaluation through purchase, fulfillment, repeat use, and engagement with additional products across our portfolio. The DARE Health Hub also allows us to maintain that relationship beyond a single transaction.

    對 Daré 而言,DARE Health Hub 建立了與我們所服務女性之間的直接連結。它讓我們能更清楚掌握完整的客戶旅程,從最初的認知與產品評估,到購買、履約交付、重複使用,以及與我們產品組合中其他產品的互動。DARE Health Hub 也使我們能在單次交易之外維持這段關係。

  • As women return for information, additional support, or repeat purchases, we have the opportunity to build trust, deepen engagement, and introduce other Daré products that may address their needs at different stages of life. As our portfolio grows from vaginal health to sexual health and over time, menopause, each product can benefit from the same digital infrastructure, provider relationships, and expanding customer base.

    當女性回來尋求資訊、額外支持或重複購買時,我們就有機會建立信任、深化互動,並介紹其他可能在不同人生階段滿足其需求的 Daré 產品。隨著我們的產品組合從陰道健康擴展到性健康,並隨時間推進至更年期領域,每一項產品都能受益於相同的數位基礎設施、醫療提供者關係與不斷擴大的客戶基礎。

  • We believe that shared foundation can make each successive launch more efficient while increasing the long-term value of the platform as a whole. We are also building awareness through trusted voices in women’s health.

    我們相信,這個共享的基礎能讓後續每一次上市更有效率,同時提升整體平台的長期價值。我們也正透過女性健康領域中值得信賴的聲音來建立認知。

  • Podcasts, clinician conversations, and influencer interviews allow us to engage women in credible, relevant settings where they are already seeking information about their health. These channels help translate awareness into action by educating women, introducing them to Daré products, and creating clear pathways into the Daré ecosystem.

    Podcast、臨床醫師對談與意見領袖訪談,讓我們能在可信且相關的情境中與女性互動,而她們本就會在這些場域尋找健康資訊。這些渠道透過教育女性、介紹 Daré 產品,並建立清晰的導流路徑進入 Daré 生態系,協助把認知轉化為行動。

  • These conversations have also reinforced the need we set out to address. We are hearing firsthand that women are actively seeking solutions developed specifically for them, and they want better information, greater access, and credible options they can trust. That response has been encouraging, and it validates both the products we are bringing forward and the commercial approach that we are building around them.

    這些對話也再次強化了我們著手解決的需求。我們第一手聽到女性正積極尋找專為她們開發的解決方案,她們希望獲得更好的資訊、更高的可及性,以及可信賴的可靠選項。這樣的回饋令人鼓舞,也驗證了我們正在推進的產品,以及我們圍繞這些產品所建立的商業方法。

  • That brings me to how we will evaluate performance during the early launch period. We are focused on three primary groups of commercial indicators, each designed to give us a clear view of how demand is developing and where we are seeing the strongest opportunities to scale.

    接下來談談我們將如何在早期上市期間評估表現。我們聚焦於三大類商業指標,每一類都旨在讓我們清楚掌握需求如何發展,以及我們在哪些方面看到最強的擴張機會。

  • The first is consumer adoption. Initial interest is important, but the stronger measure is whether that interest converts into a purchase and whether a positive initial experience leads to recurring demand. These indicators will help us understand who our customers are, how they discover our products, and what drives them to return.

    第一類是消費者採用。初期興趣固然重要,但更強的衡量方式是該興趣是否轉化為購買,以及正向的初次體驗是否帶來重複需求。這些指標將幫助我們了解客戶是誰、他們如何發現我們的產品,以及驅動他們回流的因素。

  • The second is provider adoption. Providers play an important role in establishing credibility and connecting women with appropriate solutions. Initial provider trial is a positive first step, but consistent prescribing, recommending, and stocking will be indicators that our products are becoming part of routine clinical practice.

    第二類是醫療提供者採用。醫療提供者在建立可信度並將女性連結到適當解決方案方面扮演重要角色。初期的醫療提供者試用是正向的第一步,但持續開立處方、推薦與備貨,將是我們產品正在成為日常臨床實務一部分的指標。

  • And the third is commercial efficiency, which will help us determine which channels are producing the strongest results, where additional investment is warranted, and how effectively we’re translating commercial spending into sustained customer demand.

    第三類是商業效率,這將幫助我們判斷哪些渠道帶來最強成果、哪些地方值得追加投資,以及我們把商業支出轉化為可持續客戶需求的效率如何。

  • Taken together, these indicators will provide a comprehensive view of adoption, customer behavior, and the efficiency of our commercial model. For 2026, our objective is disciplined execution and commercial validation.

    綜合而言,這些指標將提供對採用情況、客戶行為,以及我們商業模式效率的全面視角。對 2026 年而言,我們的目標是有紀律的執行與商業驗證。

  • We’re establishing the performance benchmarks, customer relationships, and repeatable processes needed to support stronger and more efficient growth in 2027 and beyond. I’d now like to highlight several of our other programs where we have made important progress recently.

    我們正在建立績效基準、客戶關係與可複製的流程,以支持 2027 年及其後更強且更有效率的成長。接下來我想重點說明我們其他幾個近期取得重要進展的計畫。

  • Ovaprene, our investigational hormone-free monthly intravaginal contraceptive, continues to advance through its pivotal Phase III study. During the quarter, we reported positive interim results, and the independent Data Safety Monitoring Board recommended that the study continue without modification.

    Ovaprene——我們的研究用、無荷爾蒙每月一次陰道內避孕產品——持續推進其關鍵性第三期(Phase III)研究。本季我們公布了正向的期中結果,且獨立資料安全監測委員會(DSMB)建議研究在不作修改的情況下繼續進行。

  • We expect to enroll sufficient subjects in 2026 to achieve at least 2,500 menstrual cycles of exposure in 2027, supporting a top-line data announcement in 2027. We expect to complete enrollment with between 450 to 500 participants, but less than 250 completers, which was the original FDA-requested target. In August of 2026 this year, the FDA approved our proposed protocol amendment to remove the expectation of 250 completers. While in this approval, FDA continued to strongly recommend a minimum of 250 completers and expressed belief that it may be necessary to adequately characterize the safety of Ovaprene.

    我們預期在 2026 年招募足夠受試者,以在 2027 年達成至少 2,500 個月經週期的暴露量,並支持於 2027 年公布主要(top-line)數據。我們預期完成招募的人數介於 450 至 500 名參與者之間,但完成者(completers)將少於 250 人;而 250 名完成者原本是 FDA 要求的目標。今年 2026 年 8 月,FDA 核准了我們提出的方案修訂,移除對 250 名完成者的期待。然而在此核准中,FDA 仍強烈建議至少要有 250 名完成者,並表示相信這可能是充分刻畫 Ovaprene 安全性所必需的。

  • Based on the interim safety data reviewed by the DSMB, including the absence of new types of adverse events or increased frequency of adverse events with prolonged use, and the study’s expected achievement of at least 2,500 menstrual cycles of exposure, we believe the amended protocol will generate sufficient safety data to support a pre-market approval submission.

    根據 DSMB 審查的期中安全性資料,包括未出現新的不良事件類型,或在延長使用下不良事件發生頻率增加,以及研究預期可達成至少 2,500 個月經週期的暴露量,我們相信修訂後的方案將產生足夠的安全性資料,以支持提交上市前核准(PMA)申請。

  • We plan to continue to engage with the FDA on this point. With no FDA-approved monthly hormone-free intravaginal contraceptive currently available, Ovaprene has the potential to offer women an important new option in a category where meaningful innovation remains limited.

    我們計畫就此議題持續與 FDA 溝通。由於目前尚無 FDA 核准的每月一次、無荷爾蒙的陰道內避孕產品可用,Ovaprene 有潛力在一個實質創新仍相對有限的類別中,為女性提供一個重要的新選項。

  • We also initiated a Phase II study of DARE-HPV, and that’s expected to enroll approximately 100 women with persistent high-risk HPV infection, with top-line results expected in 2027. The Phase II study is supported by a contract funded by ARPA-H.

    我們也啟動了 DARE-HPV 的第二期(Phase II)研究,預計將招募約 100 名持續高風險 HPV 感染的女性,並預期於 2027 年取得主要(top-line)結果。該第二期研究由 ARPA-H 資助的合約所支持。

  • During the quarter, in addition to the funding under the contract through ARPA-H, we also received a funding award notice for a second $1 million tranche from the NIAID, bringing the total funding across the project period that began in December 2024 to $2 million. DARE to RECLAIM, an estradiol progesterone intravaginal ring, represents another important opportunity. Activities to support commercial availability through 503B compounding pathway are underway, with dispensing targeted to begin in 2027.

    在本季度,除了透過 ARPA-H 合約所提供的資金外,我們也收到來自 NIAID 的第二筆 100 萬美元分期資金授予通知,使自 2024 年 12 月開始之專案期間的總資金達到 200 萬美元。DARE to RECLAIM(雌二醇/黃體酮陰道內環)代表另一項重要機會。目前正進行支援透過 503B 調劑(compounding)途徑實現商業供應的相關活動,目標於 2027 年開始配藥發放。

  • Turning to our earlier-stage pipeline, these programs extend across contraception, pelvic pain, preterm birth, and other areas where women continue to face significant unmet needs and represent multiple opportunities to expand our commercial portfolio and create value over time.

    接著談我們較早期的研發管線,這些計畫涵蓋避孕、骨盆疼痛、早產,以及其他女性仍面臨重大未被滿足需求的領域,並代表多項機會,可隨時間擴大我們的商業產品組合並創造價值。

  • Importantly, we’re advancing many of these programs through collaborations and non-dilutive funding. Our NIH and Bill & Melinda Gates Foundation funding contracts, as well as relationships with organizations including Theramex, the University of Copenhagen, and Australia’s Research and Development Incentives program, allow us to access external expertise and capital while maintaining a disciplined approach to investment. I’d now like to hand the call back over to Marty for a financial update.

    重要的是,我們正透過合作與非稀釋性資金推進其中許多計畫。我們與 NIH 及比爾與梅琳達・蓋茲基金會的資助合約,以及與包括 Theramex、哥本哈根大學與澳洲研發激勵計畫等機構的合作關係,使我們能在維持嚴謹投資紀律的同時,取得外部專業與資金。我現在想把電話交回給 Marty,請他提供財務更新。

  • Mardee Haring-layton - Chief Accounting Officer

    Mardee Haring-layton - Chief Accounting Officer

  • Thank you, Sabrina. We ended the quarter with approximately $12.6 million in cash and cash equivalents as of June 30, 2026, and a working capital deficit of approximately $0.2 million. Our working capital is calculated as current assets less current liabilities, which included a deferred grant funding liability of approximately $15 million.

    謝謝你,Sabrina。截至 2026 年 6 月 30 日,我們在本季度末持有約 1,260 萬美元的現金及約當現金,營運資金赤字約 20 萬美元。我們的營運資金係以流動資產減去流動負債計算,其中包含約 1,500 萬美元的遞延補助款資金負債。

  • Total revenue for the second quarter was approximately $0.2 million, compared with approximately negative $21,000 in the same period last year. As you recall from last year, we had an accounting adjustment related to XACIATO royalties.

    第二季總營收約為 20 萬美元,相較去年同期約為負 2.1 萬美元。如各位記得,去年我們有一項與 XACIATO 權利金相關的會計調整。

  • Revenue for the second quarter 2026 consisted solely of research and development services and royalty revenue. Because Flora Sync LF5 sales began in July, our second quarter results do not include revenue from that product. Selling, general and administrative expenses were approximately $2.6 million, compared with approximately $2.4 million in the second quarter of 2025.

    2026 年第二季營收僅包含研發服務與權利金收入。由於 Flora Sync LF5 的銷售於 7 月才開始,我們第二季的結果不包含該產品的營收。銷售、一般及行政費用約為 260 萬美元,相較 2025 年第二季約為 240 萬美元。

  • The increase primarily reflects a non-cash write-down of previously deferred offering costs, along with investments in personnel and commercial readiness activities supporting our expanded business strategy. These increases were partially offset by lower professional services and stock-based compensation expenses.

    增加主要反映先前遞延發行成本的非現金減記,以及在人員與支援我們擴大業務策略之商業就緒活動上的投資。上述增加部分被較低的專業服務費用與股份基礎給付費用所抵銷。

  • Research and development expense decreased to approximately $0.2 million from approximately $1.4 million in the prior year period. The decrease reflects significant contra R&D expense associated with non-dilutive funding that offset direct program costs, as well as lower spending across several programs. This demonstrates the value of our non-dilutive funding strategy and our continued focus on disciplined capital allocation.

    研發費用由去年同期約 140 萬美元降至約 20 萬美元。下降反映與非稀釋性資金相關的顯著研發費用抵減(contra R&D expense),其抵銷了直接的專案成本,以及多個計畫支出降低。這展現了我們非稀釋性資金策略的價值,以及我們持續聚焦於嚴謹資本配置。

  • Net loss for the quarter improved to approximately $3 million, compared with a loss of approximately $4 million in the prior year period. Looking ahead, we began recording revenue from Flora Sync LF5 sales in July and expect to begin recording revenue from DARE to PLAY Sildenafil Cream in the third quarter.

    本季淨損改善至約 300 萬美元,相較去年同期約 400 萬美元的虧損。展望未來,我們已於 7 月開始認列 Flora Sync LF5 銷售收入,並預期於第三季開始認列 DARE to PLAY 西地那非乳膏(Sildenafil Cream)的收入。

  • With revenue from DARE to RECLAIM estradiol progesterone IVR targeted to begin in 2027. We are building toward a diversified multi-product revenue profile across 2026 and 2027. As always, I encourage investors to review our quarterly report on Form 10-Q, filed today with the SEC, for more detailed discussion of our financial results, liquidity, and capital resources and risk factors.

    而 DARE to RECLAIM 雌二醇/黃體酮陰道內環(IVR)的收入目標於 2027 年開始認列。我們正朝向在 2026 年與 2027 年建立多元化、多產品的營收結構邁進。一如既往,我鼓勵投資人查閱我們今日向 SEC 提交的 Form 10-Q 季報,以取得對我們財務結果、流動性與資本資源及風險因素更詳細的討論。

  • Back to you, Sabrina.

    交回給你,Sabrina。

  • Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

    Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

  • Thank you, Marty. Daré is entering an important new phase in its evolution, with commercial execution underway and multiple opportunities to create value across the portfolio. We now have our first directly commercialized product on the market, and DARE to PLAY Sildenafil Cream is approaching prescription dispensing and a commercial platform designed to support the products that follow. This is the foundation of a scalable multi-product business focused exclusively on addressing significant unmet needs in women’s health.

    謝謝你,Marty。Daré 正進入其演進過程中的重要新階段,商業執行已在進行中,且在整體產品組合上有多項創造價值的機會。我們現在已有第一個由我們直接商業化的產品上市,而 DARE to PLAY 西地那非乳膏正接近處方配藥發放,同時我們也建立了一個商業平台,用以支援後續產品。這是可擴展的多產品業務基礎,專注於解決女性健康領域重大且未被滿足的需求。

  • At the same time, our development pipeline continues to advance. Together with our earlier-stage programs, these assets provide multiple clinical, regulatory, and commercial milestones ahead. By combining focused commercial investment with strategic collaborations and meaningful non-dilutive funding, we can continue advancing a broad portfolio while directing resources towards the programs and activities with the greatest potential to create value.

    同時,我們的研發管線持續推進。連同我們較早期的計畫,這些資產在未來將帶來多項臨床、法規與商業里程碑。透過結合聚焦的商業投資、策略性合作以及具意義的非稀釋性資金,我們能持續推進廣泛的產品組合,同時將資源導向最有潛力創造價值的計畫與活動。

  • What makes this moment different is that the pieces are now coming together. We believe this positions Daré to build commercial momentum, reach more women with differentiated solutions, and create meaningful long-term value for patients and shareholders.

    此刻之所以不同,在於各個拼圖如今正逐步到位。我們相信,這使 Daré 能夠建立商業動能,以具差異化的解決方案觸及更多女性,並為病患與股東創造具意義的長期價值。

  • I will now turn the call back to the operator for any questions.

    我現在把電話交回給接線員,進行提問。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Douglas Tsao, H.C. Wainwright.

    Douglas Tsao,H.C. Wainwright。

  • Douglas Tsao - Analyst

    Douglas Tsao - Analyst

  • Hi. Hi. Can you hear me? Can you hear me?

    嗨。嗨。你聽得到我嗎?你聽得到我嗎?

  • Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

    Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

  • Yes.

    聽得到。

  • Douglas Tsao - Analyst

    Douglas Tsao - Analyst

  • Okay, great. Hi, Sabrina. Thanks, and congrats on the progress.

    好,太好了。嗨,Sabrina。謝謝,也恭喜你們的進展。

  • Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

    Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

  • Hi.

    嗨。

  • Douglas Tsao - Analyst

    Douglas Tsao - Analyst

  • I guess just maybe as a starting point, I think it’d be helpful to hear your thoughts on the near term commercial portfolio. I mean, FloraSync and DARE to PLAY as well as DARE to RECLAIM, because in a lot of ways, when I think that these products, they sort of have very different profiles, from an end user, and perhaps somewhat have different needs from a promotion standpoint.

    我想也許先從一個起點開始,我覺得聽聽你對短期商業產品組合的看法會很有幫助。我的意思是,FloraSync、DARE to PLAY 以及 DARE to RECLAIM,因為在很多方面,當我想到這些產品時,它們從終端使用者角度來看有相當不同的特性,而且在推廣層面可能也有些不同的需求。

  • I’m curious how you sort of think about pulling those together. Do you sort of anticipate building a Daré brand or do you think that these products should have their own brand that sort of stands on their own? Thank you.

    我很好奇你如何把它們整合在一起思考。你是否預期建立一個 Daré 品牌,或是你認為這些產品應該各自擁有能獨立成立的品牌?謝謝。

  • Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

    Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

  • Yeah, great question, and thank you for asking about that. While on the one hand they definitely are different, right? FloraSync LF5 is a non-prescription probiotic. DARE to PLAY Sildenafil Cream is an arousal cream, and it’s prescription. DARE to RECLAIM estradiol progesterone intravaginal ring is specifically for menopause hormone therapy.

    是的,這是個很好的問題,也謝謝你提出。從一方面來看,它們確實不同,對吧?FloraSync LF5 是非處方的益生菌。DARE to PLAY 西地那非乳膏是一種喚起(arousal)乳膏,而且是處方產品。DARE to RECLAIM 雌二醇/黃體酮陰道內環則是專門用於更年期荷爾蒙治療。

  • On the one hand, yes, there may be overlap between the women using the products and in some cases they may be distinct users. What all of the products have in common is that they’re all based on clinical evidence, they’re all based on credible science. They’re all products that can be very easily understood and talked about, and kind of digested by both women directly, but also healthcare providers. That’s really distinct.

    一方面,是的,使用這些產品的女性之間可能有重疊,而在某些情況下也可能是不同的使用者。所有產品的共同點在於:它們都以臨床證據為基礎,都建立在可信的科學之上。它們也都是非常容易被理解、被討論的產品,無論是女性直接面對,或是醫療照護提供者,都能夠消化與溝通。這點非常獨特。

  • To your question about the Daré brand, we do think the Daré brand is very important because, to our knowledge, we remain the only biotech company working broadly and solely across women’s health therapeutics to bring solutions like this to market.

    至於你問到 Daré 品牌,我們確實認為 Daré 品牌非常重要,因為據我們所知,我們仍是唯一一家在女性健康治療領域進行廣泛且專注(solely)布局的生技公司,致力於將這類解決方案推向市場。

  • We have a very, very strong and credible brand with the healthcare provider community, and we are really leveraging that brand to the consumer community as well. We do think it’s really important, and in fact, that’s why all the products have DARE, which is our ticker symbol, have DARE in the name, and we love that kind of play on words and that opportunity to brand that way.

    我們在醫療照護提供者社群中擁有非常、非常強而可信的品牌,而我們也正把這個品牌延伸到消費者社群。我們確實認為這非常重要;事實上,這也是為什麼所有產品名稱中都包含 DARE(我們的股票代號),我們喜歡這種文字上的巧思,以及以這種方式進行品牌塑造的機會。

  • In terms of the strategy, and I talked about this a little bit in the remarks, it really allows us to build awareness through a very focused and measurable approach that prioritizes whatever channels are most efficient for these consumer campaigns, as well as really focusing on the healthcare provider engagement. That is, I think, something unique that we can do given the credible science behind our products.

    就策略而言,我在發言中也稍微提到,這確實讓我們能以非常聚焦且可衡量的方法來建立認知度,優先選擇對這些消費者行銷活動最有效率的各種渠道,同時也真正聚焦於醫療照護提供者的互動。我認為,鑑於我們產品背後具可信度的科學基礎,這是我們能做到的一項獨特之處。

  • Then making sure that across the portfolio, we are really targeting digital marketing and patient education and leveraging the DARE Health Hub as that one central commercial platform for that, so that we can make sure that we are reaching women that are actively seeking solutions. It allows us also to kind of look at the different channels and allocate capital accordingly. I think the approach is really working.

    接著,確保在整個產品組合中,我們真正鎖定數位行銷與病患教育,並運用 DARE Health Hub 作為單一的核心商業平台來承載這些工作,如此我們就能確保觸及正在積極尋求解決方案的女性。這也讓我們能檢視不同渠道並據此配置資本。我認為這個方法確實奏效。

  • What we have seen with DARE to PLAY Sildenafil Cream, even though it is not dispensing yet, is that, as I mentioned, there is a really nice healthy mix between prescriptions coming in from providers that are writing those prescriptions for patients that they are seeing, either in their offices or through their dedicated telehealth practices. We are also seeing a really nice mix of women that are going through the telehealth option that we provide on the DARE Health Hub.

    我們在 DARE to PLAY 西地那非乳膏(Sildenafil Cream)上看到的是,儘管目前尚未開始配藥,但如我所提到的,來自醫療提供者的處方與組合相當健康;這些提供者會為他們正在看診的病患開立處方,不論是在診間或透過其專門的遠距醫療(telehealth)服務。我們也看到一個很不錯的組合:有不少女性透過我們在 DARE Health Hub 上提供的遠距醫療選項進行。

  • That really means that we are reaching women kind of where they are seeking their information. If they are getting their information and they are looking for solutions online and directly, they are likely going to be using our telehealth option on the DARE Health Hub. Or if they already have maybe a trusted healthcare provider resource, it is great to see that those providers are writing as well.

    這確實意味著,我們是在女性尋找資訊的所在之處觸及她們。如果她們透過網路與直接管道取得資訊並尋找解決方案,她們很可能會使用我們在 DARE Health Hub 上的遠距醫療選項。或者,如果她們已經有可能信任的醫療照護提供者資源,也很高興看到這些提供者同樣在開立處方。

  • So I know that was a long answer to your question, but hopefully that gives you some sense that there really is a through line between the products, and that through line is that credible science, and that is the Daré brand, and we really think that that brand is so important. It is really one of the big differentiators for us as a company, and importantly, our products for women.

    所以我知道這對你的問題來說是個很長的回答,但希望能讓你感受到,產品之間確實有一條清晰的主線,而那條主線就是可信的科學基礎,以及 Daré 品牌;我們真的認為這個品牌非常重要。它確實是我們作為一家公司的重要差異化因素之一,更重要的是,對我們面向女性的產品而言也是如此。

  • Douglas Tsao - Analyst

    Douglas Tsao - Analyst

  • Frida, do you think that that brand is going to resonate more with clinicians, or do you ultimately see that as a brand that you would like to have resonate with patients?

    Frida,你認為這個品牌會更能引起臨床醫師的共鳴,還是你最終希望它作為一個能與病患產生共鳴的品牌?

  • Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

    Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

  • Yeah. Really with both. We have those established relationships across the women’s health healthcare community. Obviously that’s been a place we’ve been able to lean into right away. Then we’ve been using those relationships, obviously, to educate providers and have them educate each other. They’re definitely a trusted source for women.

    是的,兩者都會。我們在女性健康的醫療照護社群中已建立起這些既有關係。顯然,那一直是我們能立刻著力的地方。接著我們也運用這些關係,當然,是用來教育醫療提供者,並讓他們彼此教育。他們絕對是女性信任的資訊來源。

  • But we can also leverage those same relationships through those influencer providers, trusted sources of information online so that we can build our brand directly with women. Obviously, the providers know us today, already. We’re building that brand with women through a lot of these initiatives that are going live right now that we talked about.

    但我們也能透過那些具影響力的醫療提供者,將同樣的關係延伸到線上作為可信的資訊來源,從而直接與女性建立我們的品牌。顯然,醫療提供者今天已經認識我們了。我們正透過我們談到、且現在正在上線的許多計畫與行動,來與女性建立這個品牌。

  • Douglas Tsao - Analyst

    Douglas Tsao - Analyst

  • Okay. That’s very helpful. If I can, just one more question on DARE to RECLAIM, because I think that that’s a product opportunity that’s not that far away, but has a lot of tailwinds going for it, in particular, some of the regulatory action in terms of removing sort of warnings around hormone replacement therapy. Obviously, there are millions of scripts written for hormone replacement therapy every year. How do you sort of think about converting them from often compounded products, oral products, et cetera, to DARE to RECLAIM? Thank you.

    好的。這非常有幫助。如果可以的話,我還想再問一個關於 DARE to RECLAIM 的問題,因為我認為那是一個不算太遙遠的產品機會,而且有很多順風因素,特別是監管層面的一些動作,例如移除與荷爾蒙替代療法相關的某些警語。顯然,每年都有數百萬張荷爾蒙替代療法的處方。你們如何看待把它們從常見的調劑配製(compounded)產品、口服產品等等,轉換到 DARE to RECLAIM?謝謝。

  • Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

    Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

  • Thank you for asking about that, by the way. I love talking about this product. I know I didn’t talk about it so much in the opening remarks because they’re obviously so focused on what’s happening today. As you mentioned, this is something we’re targeting to have on market in 2027.

    順帶一提,謝謝你問到這個。我很喜歡談這個產品。我知道我在開場發言中沒有談太多,因為開場顯然更聚焦於當下正在發生的事情。如你所提到的,我們的目標是讓它在 2027 年上市。

  • I think the best way to describe how we’re thinking about it and how the healthcare provider community is thinking about it is, I just had a call a little bit ago with one of the clinicians that was very instrumental and has been very much seen in all the press and talk about removing the black box warning from the hormone therapy products. She can’t wait for DARE to RECLAIM to be available because, as she keeps reminding me, they just don’t have anything like this available today.

    我認為,描述我們如何思考、以及醫療照護提供者社群如何思考的最佳方式是:我不久前才與一位臨床醫師通話,她在媒體報導與討論中非常關鍵,也一直被視為推動移除荷爾蒙治療產品黑框警語(black box warning)的重要人物。她迫不及待希望 DARE to RECLAIM 能上市,因為如她不斷提醒我的,他們目前真的沒有任何類似的產品可用。

  • With the clinical evidence that we’re generating, the pharmacokinetic levels of both estradiol, this is basically what is going to resolve the symptoms, and the progesterone, which is there for endometrial safety, that have been demonstrated through pharmacokinetics to be the levels that are needed, and in a non-oral form, and it’s clinically studied. She keeps highlighting, my gosh, can’t you go faster? There’s a shortage of patches.

    就我們正在產生的臨床證據而言,雌二醇(estradiol)的藥物動力學(pharmacokinetic)濃度——基本上這就是將解決症狀的關鍵——以及黃體素(progesterone)的藥物動力學濃度——其目的在於子宮內膜安全性——已透過藥物動力學證明達到所需的濃度水準,而且是非口服形式,並且經過臨床研究。她一直強調:天啊,你們不能更快一點嗎?貼片還短缺。

  • We’re cobbling together these care solutions for our patients, patches for the estrogen and some other dosing regimen for the progesterone, and it’s cumbersome and it’s clunky. We are super excited. I think, again, this is one where the product is going to do the work. The product’s already done the work to demonstrate the pharmacokinetics, to demonstrate the data.

    我們正在為病患拼湊這些照護方案:用貼片提供雌激素,再用其他給藥方案提供黃體素;這既麻煩又不順。我們非常興奮。我想,再次強調,這是一個產品本身就會發揮作用的案例。這個產品已經完成了它該做的工作:證明藥物動力學、證明數據。

  • The product has been responsive to what The Menopause Society and the medical community have been asking for. We definitely think this is one where the product’s going to do the heavy lift in terms of moving patients, moving women from something that is not as easy to use, that is not as convenient, and does not follow the recommendations of The Menopause Society in such a clear way, to a product that does.

    這個產品回應了 The Menopause Society(更年期學會)以及醫學界一直在要求的內容。我們確實認為,這將是一個產品本身能在推動病患轉換上扮演主要角色的案例:把病患、把女性,從不那麼容易使用、不那麼便利、且無法如此清楚遵循 The Menopause Society 建議的方案,轉換到一個能做到這些的產品上。

  • Operator

    Operator

  • Okay, great. Thank you so much.

    好的,很棒。非常感謝。

  • Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

    Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

  • We can’t move fast enough on this one. Yeah. Thank you, Doug.

    我們在這個項目上怎麼快都不夠快。是的。謝謝你,Doug。

  • Operator

    Operator

  • Thank you. We have reached the end of the Q&A session. I will now turn the call back over to Sabrina Martucci Johnson for closing remarks.

    謝謝。問答環節到此結束。我現在把電話交回給 Sabrina Martucci Johnson 作結語。

  • Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

    Sabrina Martucci Johnson - Chief Executive Officer, President, and Director

  • Great. Well, thank you so much. As we close, I really want to take another moment to share how excited we are here at Daré. We’ve worked for years to develop solutions that address meaningful gaps in women’s health, and it is incredibly rewarding to see that work reaching women while our broader portfolio continues to advance. We believe this is the beginning of an important new chapter for Daré, and we look forward to sharing our continued progress with you.

    太好了。非常感謝。在結束之前,我真的想再花點時間分享我們在 Daré 有多麼興奮。我們多年來致力於開發能填補女性健康重要缺口的解決方案,而看到這些成果觸及女性、同時我們更廣泛的產品組合持續推進,令人非常欣慰。我們相信這是 Daré 一個重要新篇章的開始,也期待與各位分享我們後續的持續進展。

  • Operator

    Operator

  • The meeting has now concluded. Thank you all for joining this conference, and you may now disconnect.

    會議現在結束。感謝各位參加本次電話會議,您現在可以掛線。