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
Ladies and gentlemen, thank you for standing by. Hello, and welcome to the conference call hosted by Dare Bioscience to review the company's first quarter 2026 financial results, and to provide a business update. This call is being recorded. My name is [King], and I will be your operator today.
各位女士、先生,感謝您稍候。您好,歡迎參加由 Dare Bioscience 主辦的電話會議,本次會議將回顧公司 2026 年第一季財務業績,並提供業務最新進展。本通話將被錄音。我叫 [King],今天將擔任您的接線員。
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.
今天與會的 Dare 團隊成員包括:總裁兼執行長 Sabrina Martucci Johnson,以及首席會計官 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 to the Dare Bioscience financial results and business update call for the quarter ended March 31, 2026. Today, we will review our financial results, provide updates on our clinical pipeline and discuss the continued execution of our expanded business strategy.
各位下午好,歡迎參加 Dare Bioscience 截至 2026 年 3 月 31 日止季度的財務業績與業務更新電話會議。今天我們將回顧財務結果,提供臨床產品線的最新進展,並討論我們擴大後的業務策略之持續執行。
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.
該策略包含雙軌並行:一方面透過 503B 調劑(compounding)將自有配方商業化,同時推進 FDA 核准;另一方面,將部分解決方案作為不需處方的品牌化消費者健康產品推進。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。
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.
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,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。
Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements.
本通話中任何非歷史事實的陳述,均應視為前瞻性陳述。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 March 31, 2026, which was filed today, and our annual report on Form 10-K for the year ended December 31, 2025. Please note that in the context of this call includes time-sensitive information that is current only as of today, May 14, 2026.
前瞻性陳述在其整體上均受公司向 SEC 申報文件中的警示性聲明所限制,包括我們今天提交的截至 2026 年 3 月 31 日止季度之 Form 10-Q 季度報告,以及截至 2025 年 12 月 31 日止年度之 Form 10-K 年度報告。另請注意,本次通話內容包含具時效性的資訊,僅以今日(2026 年 5 月 14 日)為準。
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, we are referring to compounding drug products by outsourcing facilities registered under Section 503B of the Federal Food, Drug and Cosmetic Act using both drug substances on the FDA's interim Category 1 list. I will now turn the call over to Sabrina.
除法律要求外,Dare 不承擔在本通話後更新任何前瞻性陳述以反映新資訊或新發展的義務。我也想指出,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)所進行的藥品調劑,並使用 FDA 暫行第 1 類(interim Category 1)清單上的藥物原料(drug substances)。接下來我將把電話交給 Sabrina。
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Great. Thank you, MarDee, and good afternoon, everyone, and thank you for joining us. I am taking the call today from New York in the middle of National Women's Health Week. And this year's theme, which is Prevention, Innovation and Impact, a new era in women's health, couldn't be more relevant to our discussion this afternoon.
很好。謝謝你,MarDee,各位下午好,也感謝大家加入。我今天在紐約參與本次電話會議,正值「全國女性健康週」(National Women's Health Week)期間。今年的主題是「預防、創新與影響:女性健康的新時代」,這與我們今天下午的討論再貼切不過。
Dare was built on the conviction that women's health is an investment-grade category, not a niche, not a nice to have, not a pink ribbon in a press release, it's a category worth building, funding and holding accountable for delivering to women the health care options they deserve.
Dare 的成立基於一個信念:女性健康是一個具投資等級的領域,而不是小眾、不是可有可無、也不是新聞稿裡的一條粉紅絲帶;這是一個值得打造、值得投入資金,並且應被要求對「為女性提供她們應得的醫療選擇」交付成果的領域。
And that is exactly what we're doing today and reporting on what we've built and where we're going. Over 10 years ago, we made a decision to focus exclusively on women's health, as you know, not as a sideline, not as a franchise within a broader portfolio, as our entire reason for existing.
而這正是我們今天正在做的事——並向各位報告我們已建立的成果以及未來方向。十多年前,我們做出決定,如各位所知,專注於女性健康——不是作為副業、不是作為更大產品組合中的一條產品線,而是作為我們存在的全部理由。
Every dollar raised, every clinical trial run, every regulatory submission prepared, every partnership negotiated, all of it for one purpose, building the company with the most comprehensive pipeline comprised exclusively of differentiated products for health issues and conditions that uniquely impact women.
每一美元的募資、每一項臨床試驗、每一份法規申報文件、每一項合作夥伴談判——全部都為了一個目的:打造一家公司,擁有最全面的產品線,且完全由具差異化的產品所構成,專注於那些獨特影響女性的健康議題與疾病狀況。
From contraception to menopause, sexual health to fertility, vaginal health to human papillomavirus, we're working to close critical gaps in care with science that meets her needs. And what distinguishes Dare is not just the breadth of the pipeline, but the strategy behind it, that disciplined approach to capital allocation that pairs nondilutive grant funding with focused development so that we can move multiple programs towards the clinic simultaneously.
從避孕到更年期,從性健康到生育力,從陰道健康到人類乳突病毒(HPV),我們致力以符合女性需求的科學來彌補照護上的關鍵缺口。Dare 的與眾不同不僅在於產品線的廣度,更在於其背後的策略——以嚴謹的資本配置方式,將非稀釋性的補助資金(nondilutive grant funding)與聚焦式開發相結合,使我們能同時推動多個專案邁向臨床階段。
So it's not a single product bet. It's a portfolio of strategy that's built from the ground up for one of the most chronically underfunded areas in all of medicine despite affecting half the world's population. And we're not a company that's just getting into women's health. What 10 years of commitment looks like is what is coming into view right now.
因此,這不是押注單一產品;而是一個策略性產品組合,從零開始打造,聚焦於醫學領域中長期資金最不足的領域之一——儘管它影響全球一半人口。我們也不是一家「剛開始進入」女性健康的公司。十年的承諾所帶來的成果,如今正逐步清晰呈現。
And I also want to be precise about what kind of company Dare is, because the women's health space is attracting more and more entrants and not all of them are building the same thing. This is a growing category of women's health platform companies that offer services, telehealth subscriptions, care navigation, clinical memberships.
我也想精確說明 Dare 是一家什麼樣的公司,因為女性健康領域正吸引越來越多新進者,而並非所有人都在打造同樣的東西。現在出現一類正在成長的女性健康平台公司,提供服務、遠距醫療訂閱、照護導引、臨床會員制等。
That's what's happening. And they make products available as part of the service experience. And we respect those companies and what they're doing. But that is not what Dare is. Dare is a product company. Our mission is to develop and bring to market clinically studied, differentiated women's health products, products with real data behind them, addressing gaps where, in our view, nothing adequate exists today.
這就是正在發生的趨勢。他們把產品作為服務體驗的一部分提供。我們尊重這些公司及其所做的事。但那不是 Dare。Dare 是一家產品公司。我們的使命是開發並將經臨床研究、具差異化的女性健康產品推向市場——這些產品背後有真實數據支撐,針對我們認為目前尚無足夠解方的缺口。
The DARE Health Hub and telehealth access we provide, their infrastructure built to put those products in the hands of women efficiently. Access is essential, but the products are the point. And that distinction matters, especially for clinicians.
我們提供的 DARE Health Hub 與遠距醫療(telehealth)取得管道,是為了讓這些產品能有效率地送到女性手中而建立的基礎設施。可近性(access)至關重要,但產品才是核心。而這種區別很重要,尤其對臨床醫師而言。
When a provider writes a prescription for DARE to PLAY, they are prescribing a specific formulation with published clinical data, not some generic compounded product and not a service bundle. We're building relationships with the clinical community that are grounded in the credibility of what's in our tubes or bottles. That's a very different conversation than one built around a subscription platform.
當醫療提供者為 DARE to PLAY 開立處方時,他們開的是一個具有已發表臨床數據的特定配方,而不是某種通用的調劑產品,也不是一個服務套組。我們與臨床社群建立的關係,根基在於我們的軟管或瓶罐裡裝的是什麼,以及其可信度。這與以訂閱平台為核心的對話非常不同。
To our knowledge, Dare Bioscience has the most robust development stage pipeline of any company in the world developing products exclusively for conditions that solely affect women. We have not been able to identify a company with a comparable portfolio. Products are protectable, products can generate recurring product revenue. Products can be partnered, products can be approved by the FDA. Products can be real-world solutions.
據我們所知,Dare Bioscience 擁有全球任何一家專注開發「僅影響女性之疾病狀況」產品的公司中,最強健的開發階段產品線。我們尚未能找到具有可比擬產品組合的公司。產品可受保護、可產生可重複的產品收入;產品可以對外合作、可以獲得 FDA 核准;產品可以成為真實世界的解決方案。
And a great way to illustrate our product model is to start with DARE to PLAY. Since our last call, one of the most meaningful events we participated in was the American College of Obstetricians and Gynecologists, or ACOG, their annual conference. And I want to share what happened there because I believe it signals something important about where DARE to PLAY is headed.
要說明我們的產品模式,一個很好的切入點是 DARE to PLAY。自上次電話會議以來,我們參與的最具意義的活動之一,是美國婦產科醫師學會(American College of Obstetricians and Gynecologists,簡稱 ACOG)的年度會議。我想分享我們在那裡發生的事情,因為我相信這預示著 DARE to PLAY 的發展方向有重要訊號。
The reception we received at ACOG for DARE to PLAY was enthusiastic. Health care providers attending, and that includes OB/GYNs, women's health specialists, sexual health clinicians. They were genuinely excited about the product. And I mean, genuinely, we literally had providers who were so enthusiastic about DARE to PLAY that they were writing prescriptions for each other on the spot at the booth.
在 ACOG,DARE to PLAY 所獲得的反應非常熱烈。與會的醫療提供者,包括婦產科醫師(OB/GYNs)、女性健康專科醫師、性健康臨床醫師,他們對產品感到由衷興奮。我所說的「由衷」是字面意思——我們真的有醫師在攤位現場因為對 DARE to PLAY 太興奮,而當場互相替彼此開立處方。
That's not a marketing anecdote. That's a signal. When experienced clinicians see patients every single day and have long lamented the absence of evidence-based options for women's sexual health, they see DARE to PLAY and immediately want it for themselves and their patients. It tells you something real about the unmet need and the credibility of our product. We also have clinicians approach us about stocking DARE to PLAY directly in their offices.
這不是行銷花絮,而是一個訊號。當經驗豐富、每天都在看診的臨床醫師,長期感嘆女性性健康缺乏以證據為基礎的選項時,他們看到 DARE to PLAY,立刻就想要給自己與病患使用。這反映了真實的未被滿足需求,以及我們產品的可信度。我們也有臨床醫師主動詢問,是否能在其診所直接備貨 DARE to PLAY。
That level of interest from the provider community is exactly what a new prescription option needs to build sustainable momentum, and we are actively working to support those discussions. Providers are becoming advocates, and that's how sustainable commercial momentum is built, not just relying on advertising, but through clinician conviction. DARE to PLAY is a first-of-its-kind topical arousal cream for women.
來自醫療提供者社群的這種興趣程度,正是新的處方選項建立可持續動能所需要的,我們也正積極推進並支持這些討論。醫療提供者正在成為倡議者,而可持續的商業動能正是如此建立——不僅依賴廣告,而是透過臨床醫師的信念。DARE to PLAY 是首創(first-of-its-kind)的女性外用喚起乳霜(topical arousal cream)。
To our knowledge, there is no other sildenafil topical cream manufactured under Good Manufacturing Practice requirements with clinical data demonstrating increased genital blood flow in 10 to 15 minutes and improvements in arousal, orgasm, desire as measured by clinically validated and FDA reviewed endpoints. As we've discussed before, men have had Viagra in their medicine cabinet for over 25 years.
據我們所知,目前沒有其他在符合優良製造規範(Good Manufacturing Practice)要求下生產的西地那非(sildenafil)外用乳霜,並具備臨床數據顯示可在 10 至 15 分鐘內增加生殖器血流,且在以經臨床驗證並經 FDA 審查的終點指標衡量下,改善喚起、高潮與慾望。如同我們先前討論過的,男性的藥櫃裡擺著威而鋼(Viagra)已超過 25 年。
Women have not had a sildenafil cream formulation clinically studied and developed specifically for them, until now. An estimated 20 million women in the United States report challenges related to genital arousal. And there's not a single FDA-approved therapy that directly addresses the need, not one. And while there's not yet an FDA-approved therapy, DARE to PLAY was designed to fill the void. And as MarDee mentioned upfront, we are making DARE to PLAY available as a Section 503B compounded product.
直到現在,女性一直沒有一款專為她們進行臨床研究並開發的西地那非乳膏配方。據估計,美國約有2,000萬名女性表示在生殖器喚起方面面臨挑戰。而且沒有任何一項獲FDA核准的療法能直接滿足這項需求,一項也沒有。雖然目前仍尚無FDA核准的療法,DARE to PLAY 的設計旨在填補這個空缺。正如 MarDee 一開始提到的,我們正將 DARE to PLAY 以《第503B條》調劑產品的形式提供。
I want to reiterate again what we hear from health care providers and women because they continue to tell us the same three things about DARE to PLAY that uniquely resonates with them: It works fast; it was genuinely built by biotech; and studied for them. We also hear that following those Good Manufacturing Practices around potency and quality guidelines, so they know exactly what they're getting every single time is important.
我想再次重申我們從醫療照護提供者與女性那裡聽到的回饋,因為她們持續告訴我們,DARE to PLAY 有三個特點特別能引起共鳴:起效快;確實是由生技公司打造;並且是為女性而研究。我們也聽到,遵循關於效價與品質指引的優良製造規範(GMP)很重要,這樣她們就能確切知道每一次拿到的是什麼。
And these are not baseless statements, they're what clinical data show and what compliance with GMP requirements validates. The pre-fulfillment prescribing for DARE to PLAY sildenafil cream, as you know, has been live across 50 states since February 2026, and the clinician response we continue to see is encouraging. Bravado, the 503B registered outsourcing facility for DARE to PLAY, they're targeting dispensing to begin this summer as they continue to complete the necessary state licensing and fulfillment preparations.
而這些並非毫無根據的說法,而是臨床數據所顯示、以及符合GMP要求所驗證的結果。如各位所知,DARE to PLAY 西地那非乳膏的預先履約處方自2026年2月起已在全美50州上線,我們持續看到的臨床醫師回應令人鼓舞。Bravado 作為 DARE to PLAY 的503B註冊外包製造機構,正以今年夏季開始配藥為目標,同時持續完成必要的州級執照與履約準備。
It's a significant milestone that we have been building toward. Our 503B commercial model is asset-light and digitally native by design. We drive that consumer awareness through targeted digital marketing. Women can access DARE to PLAY through telehealth without an in-person office visit. It's a discrete, convenient option.
這是一個我們一路努力建構而來的重要里程碑。我們的503B商業模式在設計上採取輕資產、數位原生。我們透過精準的數位行銷來提升消費者認知。女性可透過遠距醫療取得 DARE to PLAY,而無需親自到診所就診。這是一個低調且便利的選擇。
Medvantx handles the fulfillment and dispensing through the DARE Health Hub with the quality infrastructure they already have in place. And so I want to reiterate again about how we think about telehealth in our model. Telehealth is an access infrastructure. It's a critical tool for getting our products to the women who need them, but it's not the business model. We're not a subscription service.
Medvantx 透過 DARE Health Hub,利用其既有的品質基礎設施來負責履約與配藥。因此我想再次重申我們如何看待遠距醫療在我們模式中的角色。遠距醫療是一種「取得管道」的基礎設施。它是將我們的產品送達有需要女性的關鍵工具,但它不是商業模式。我們不是訂閱服務。
We're not a care navigation platform with the burden that those bring. We're a product company. We're using telehealth as one channel among several to deliver clinically studied differentiated solutions efficiently. That's also why the provider relationship matters so much to us. Health care providers, again, the OB/GYNs, the women's health specialists, the primary care physicians, are not a channel to us, they are our clinical partners.
我們也不是帶有相關負擔的照護導引平台。我們是一家產品公司。我們將遠距醫療作為多個通路之一,用以高效率地提供經臨床研究、具差異化的解決方案。這也是為什麼我們如此重視與醫療提供者的關係。醫療照護提供者——再次強調,包含婦產科醫師、女性健康專科醫師、基層照護醫師——對我們而言不是通路,而是我們的臨床合作夥伴。
When we say DARE to PLAY was built specifically for women and has been clinically studied in women, that means something to a provider in a way that a generic compounded cream does not. When a clinician at ACOG asks how to stock our product in her office, she is not asking about a service. She's asking about a product she believes in and she wants to offer her patients directly.
當我們說 DARE to PLAY 是專為女性打造,並且已在女性族群中完成臨床研究時,這對醫療提供者而言具有意義,是一般的調劑乳膏無法比擬的。當 ACOG 的臨床醫師詢問如何在她的診所備貨我們的產品時,她問的不是一項服務;她問的是一個她信任、並希望直接提供給病人的產品。
That's the kind of relationship we're building, and it's built on the credibility of the product itself. As we prove out what it costs to acquire a patient digitally, and how long they stay on the product and as dispensing commences this summer, we can add channels and scale the spend accordingly.
這正是我們正在建立的關係,而其基礎來自產品本身的可信度。隨著我們驗證以數位方式獲取病人的成本、她們使用產品的持續時間,並且在今年夏季開始配藥後,我們就能增加通路並相應擴大投入。
And as our commercial footprint grows, we expect additional strategic collaborations with telehealth provider platforms, right, other ones, platform distributors and clinical networks, all in the service of getting our products to more women faster. So stay tuned. And here is what makes our approach uniquely powerful.
隨著我們的商業版圖擴大,我們預期將與更多策略性合作夥伴展開合作,包括遠距醫療提供者平台(沒錯,其他平台)、平台型經銷商以及臨床網絡,目的都是讓我們的產品更快觸及更多女性。敬請期待。以下是使我們的方法具備獨特強大之處的關鍵。
While DARE to PLAY is available for pre-fulfillment today through that 503B compounding pathway, generating real prescribing data, building clinician relationships and creating that patient demand, we are simultaneously working to advance our sildenafil cream towards the 505(b)(2) NDA pathway for FDA approval. Both can happen at the same time, and that's the power of building our products around well-characterized chemical entities, compounds with established safety databases.
雖然 DARE to PLAY 目前可透過503B調劑途徑進行預先履約,並產生真實處方數據、建立臨床醫師關係與創造病人需求;我們同時也在推進西地那非乳膏走向505(b)(2) NDA途徑,以取得FDA核准。兩者可以同時進行,而這正是我們以特性明確的化學實體來打造產品的力量所在——也就是具有既有安全性資料庫的化合物。
We can start building a market for certain of our product candidates. We build that market while we build the regulatory file and the real-world data we generate through the 503B strategy, may ultimately strengthen our NDA submission. So to our knowledge, there is no company our size in women's health that has this kind of strategic flexibility, and it's a result of how deliberately we designed our pipeline.
我們可以先為部分產品候選建立市場;在建立市場的同時,也建立法規申報檔案。而我們透過503B策略所產生的真實世界數據,最終可能強化我們的NDA申請。據我們所知,在女性健康領域,沒有一家與我們同等規模的公司具備這樣的策略彈性,而這源自我們對產品線的刻意設計。
And I want to take a moment to highlight what I believe is an underappreciated milestone for Dare and one that will mark the second quarter as a milestone for our company. Flora Sync LF5, which is our first DARE to RESTORE vaginal probiotics depository, that we are launching commercially in June of 2026.
我想花點時間強調一個我認為市場低估的里程碑——對 Dare 而言,這也將使第二季成為公司的重要里程碑。Flora Sync LF5,也就是我們第一款 DARE to RESTORE 陰道益生菌栓劑,我們將於2026年6月正式商業上市。
Seeding campaigns, so these are things designed to build clinician awareness and drive initial consumer trial. Those are beginning now in May ahead of that commercial launch. We begin to expect recording revenue from Flora Sync LF5 in June. And this will mark the first time that we have recorded direct product revenue as a company. So it is a big milestone for our company and one that we believe changes how investors should think about our story.
所謂的種子推廣活動(seeding campaigns),也就是用來提升臨床醫師認知並帶動初期消費者試用的活動,將在5月、商業上市前就開始。我們預期在6月開始認列 Flora Sync LF5 的營收。這將是我們公司首次認列直接產品營收。因此,這對公司而言是重大里程碑,我們相信這也將改變投資人看待我們故事的方式。
The DARE to RESTORE products are probiotics designed to support vaginal microbiome balance. Flora Sync LF5 is a vaginal probiotic depository developed by Probiotical, one of the world's leading probiotic research companies. The formulation is based on scientific research into vaginal microbiome composition and health. It's been studied in a 100-person clinical trial, and the findings have been published in a peer-reviewed journal. Probiotical is the exclusive manufacturer using its proprietary LF5 strain.
DARE to RESTORE 產品是一系列益生菌,旨在支持陰道微生物群的平衡。Flora Sync LF5 是由 Probiotical 開發的陰道益生菌栓劑;Probiotical 是全球領先的益生菌研究公司之一。其配方基於對陰道微生物群組成與健康的科學研究。該產品已在一項100人臨床試驗中進行研究,研究結果並已發表於同儕審查期刊。Probiotical 使用其專有的 LF5 菌株,並為獨家製造商。
We believe that level of clinical evidence distinguishes Flora Sync LF5 from the majority of vaginal probiotic depositories on the market today. And we expect it to be an important differentiator as we build the DARE to RESTORE brand. We intend to distribute DARE to RESTORE products through the DARE Health Hub, where we believe they will be complementary to our 503B prescription offerings.
我們相信,這樣等級的臨床證據使 Flora Sync LF5 有別於目前市面上多數陰道益生菌栓劑。我們也預期,這將成為我們打造 DARE to RESTORE 品牌的重要差異化因素。我們計畫透過 DARE Health Hub 來分銷 DARE to RESTORE 產品,並相信它們將與我們的503B處方產品相互補強。
Health care providers may recommend DARE to RESTORE products alongside DARE to PLAY or other Dare products as part of a comprehensive approach to women's vaginal and sexual health. Intimacy and intercourse can be one of the biggest disruptors of the vaginal microbiome and DARE to RESTORE Flora Sync LF5 is a reset and reconnect solution focused on balance, confidence, comfort and intimacy wellness.
醫療照護提供者可能會將 DARE to RESTORE 產品與 DARE to PLAY 或其他 Dare 產品一併建議,作為女性陰道與性健康的整體性方案之一。親密行為與性交可能是陰道微生物群最主要的干擾因素之一,而 DARE to RESTORE Flora Sync LF5 是一項「重置並重新連結」的解決方案,聚焦於平衡、自信、舒適與親密健康。
Next, I'll walk you through other program updates and milestones we're targeting for 2026 and 2027. DARE to RECLAIM is our proprietary monthly intravaginal ring designed to deliver bioidentical estradiol and progesterone, targeting the estimated $2.5 billion to $4.5 billion compounded hormone therapy market.
接下來,我將帶各位了解我們在2026年與2027年鎖定的其他計畫更新與里程碑。DARE to RECLAIM 是我們專有的每月一次陰道內置環(intravaginal ring),設計用以遞送生物同質性(bioidentical)雌二醇與黃體素,目標市場為估計25億至45億美元的調劑型荷爾蒙治療市場。
Women are demanding alternatives to synthetic hormones. Bioidentical hormone therapy is a category on the rise, particularly with the removal of the black box warning. And we expect DARE to RECLAIM to be the first monthly intravaginal delivery solution in this space combining bio-identical estradiol and bio-identical progesterone.
女性正在要求合成荷爾蒙以外的替代方案。生物同質性荷爾蒙治療是一個正在成長的類別,尤其是在黑框警語移除之後。我們預期 DARE to RECLAIM 將成為此領域首個每月一次的陰道內遞送解決方案,同時結合生物同質性雌二醇與生物同質性黃體素。
We're targeting to have DARE to RECLAIM available for 503B prescription fulfillment in 2027, while simultaneously pursuing activities to support an NDA filing and a pivotal Phase III clinical study utilizing the dual path strategy. Imagine the first monthly bioidentical hormone therapy IVR, including both estradiol and progesterone together in an estimated $2.5 billion to $4.5 billion market.
我們的目標是在2027年讓 DARE to RECLAIM 可用於503B處方履約;同時,透過雙軌策略推進支持NDA申報的相關工作,以及一項關鍵性第三期臨床研究。想像一下:在估計25億至45億美元的市場中,首個每月一次的生物同質性荷爾蒙治療IVR,並將雌二醇與黃體素合併於同一產品中。
That's what DARE to RECLAIM is positioned to be. And investors can invest in that potential today. And Ovaprene. Ovaprene is our monthly, intravaginal, [Technical Difficulty] candidate. And earlier this week, we announced positive interim results from our ongoing Phase III clinical trial, and that's following the second planned interim analysis by the trial's independent Data Safety Monitoring Board, or DSMB.
這正是 DARE to RECLAIM 所定位要成為的產品。而投資人今天就可以投資於這樣的潛力。接著是 Ovaprene。Ovaprene 是我們每月一次、陰道內的,[Technical Difficulty] 候選產品。本週稍早,我們公布了正在進行的第三期臨床試驗之正向期中結果,該結果是在試驗的獨立資料安全監測委員會(Data Safety Monitoring Board,DSMB)完成第二次預定期中分析之後取得。
The DSMB reviewed interim data and recommended the study continue without modification for the second time. This second consecutive positive DSMB review reinforces Ovaprene's potential as a meaningful hormone-free contraceptive alternative as it advances through its Phase III trial. The interim data showed that approximately 9% of women treated in the study had experienced a pregnancy.
DSMB 審查了期中數據,並第二次建議研究在不作任何修改的情況下繼續進行。這是連續第二次獲得 DSMB 的正面審查,進一步強化 Ovaprene 作為具意義的無荷爾蒙避孕替代方案之潛力,並持續推進其第三期臨床試驗。期中數據顯示,研究中接受治療的女性約有 9% 曾發生懷孕。
That rate is consistent with our expectations based on the results of the pre-pivotal postcoital test clinical study, as well as the last DSMB meeting. There are no new types of adverse events or tolerability concerns identified, neither an increase or decrease in the frequency of adverse events, nor the emergence of new types of adverse events was observed with prolonged Ovaprene use.
該比率與我們基於關鍵性前之性交後測試(postcoital test)臨床研究結果,以及上一次 DSMB 會議所預期的一致。未發現任何新的不良事件類型或耐受性疑慮;在延長使用 Ovaprene 的情況下,既未觀察到不良事件發生頻率的增加或減少,也未出現新的不良事件類型。
Approximately 12% of participants discontinued the study due to vaginal odor. That's the most commonly reported product-related adverse event. That rate, though, is a 5% decrease compared to the data reviewed by the DSMB last summer in July of 2025. No serious adverse events related to the study device were identified and a majority of the participants who completed the study reported that they would be very likely or likely to use Ovaprene if it became available.
約有 12% 的受試者因陰道異味而退出研究。這是最常被回報、與產品相關的不良事件。不過,與 DSMB 於 2025 年 7 月去年夏天審查的數據相比,該比率下降了 5%。未發現與研究裝置相關的嚴重不良事件,且多數完成研究的受試者表示,若 Ovaprene 上市,她們「非常可能」或「可能」會使用 Ovaprene。
The DSMB reviewed data from 340 study subjects contributing nearly 1,800 menstrual cycles of safety data, and that's a meaningful proportion of the study's 2,500 cycle target. The study protocol calls for at least 2,500 cycles of exposure and 250 subjects completing 13 menstrual cycles of use.
DSMB 審查了來自 340 名研究受試者的數據,合計提供近 1,800 個月經週期的安全性數據,這已占研究 2,500 個週期目標的相當比例。研究方案要求至少 2,500 個暴露週期,並有 250 名受試者完成 13 個月經週期的使用。
Based on the current enrollment trends, we would expect to achieve the 2,500 cycles of exposure before 250 subjects complete 13 menstrual cycles of use. Importantly, the interim safety data suggests that prolonged product use was not associated with the emergence of new types of adverse events or an increased frequency of adverse events.
根據目前的入組趨勢,我們預期在 250 名受試者完成 13 個月經週期使用之前,就能達成 2,500 個暴露週期。重要的是,期中安全性數據顯示,延長使用產品並未與新型不良事件的出現或不良事件發生頻率的增加相關。
And we believe that may support the sufficiency of fewer than 250 subjects completing 13 cycles to evaluate Ovaprene's safety profile. And we do intend to engage with the FDA regarding these findings. So that's two consecutive positive DSMB reviews on Ovaprene and a pregnancy rate consistent with expectations, tolerability data that improved from the first interim look and a majority of users who say they would use it again.
我們認為,這可能支持以少於 250 名受試者完成 13 個週期,仍足以評估 Ovaprene 的安全性概況。我們也確實打算就這些發現與 FDA 進行溝通。因此,Ovaprene 已連續兩次獲得 DSMB 的正面審查;懷孕率符合預期;耐受性數據較第一次期中檢視有所改善;且多數使用者表示願意再次使用。
That's a differentiated potential first-in-category asset advancing through its pivotal clinical trial. There are currently no FDA-approved, hormone-free monthly intravaginal contraceptives. And a growing number of women, particularly younger women, are actively seeking alternatives to hormonal contraceptive. Ovaprene is designed to be the answer.
這是一項具差異化、潛在「同類首創」(first-in-category)的資產,正推進其關鍵性臨床試驗。目前尚無 FDA 核准的無荷爾蒙、每月一次的陰道內避孕產品。且越來越多女性,尤其是年輕女性,正積極尋找荷爾蒙避孕的替代方案。Ovaprene 的設計就是為了成為答案。
We currently expect to complete enrollment sufficient to achieve at least 2,500 cycles of exposure in 2026. And completing enrollment in 2026 puts the primary endpoint analysis within reach in 2027. Now a little bit about DARE-HPV. DARE-HPV is perhaps our most underappreciated development program. An estimated 6 million women in the United States alone acquire a high-risk HPV infection every single year.
我們目前預期在 2026 年完成足以達成至少 2,500 個暴露週期的入組。而在 2026 年完成入組,將使 2027 年進行主要終點分析變得可期。接下來簡要談談 DARE-HPV。DARE-HPV 可能是我們最被低估的開發計畫。僅在美國,每年估計就有 600 萬名女性感染高風險 HPV。
And today, every single one of them is being managed with watchful waiting or surgery. There is no drug therapy. That represents a completely untreated patient population with a clear clinical need and no existing direct competition in the pharmacologic space. High-risk HPV types are the underlying cause of virtually all cervical cancer cases in the United States, 99% of them.
而在今天,她們每一位都只能以「觀察等待」或手術方式管理。沒有任何藥物治療。這代表一個完全未被治療、具有明確臨床需求且在藥物領域沒有直接競爭者的病患族群。高風險 HPV 型別是美國幾乎所有子宮頸癌病例的根本原因,占 99%。
And for decades, women with persistent high-risk HPV infection have been told to watch and wait to monitor and hope that the virus clears on its own. If it doesn't, the only recourse has been surgery once those precancerous changes appear. As I mentioned, there's not a single FDA-approved pharmacologic treatment for high-risk HPV infection, not one, and we are developing one with ARPA-H funding.
數十年來,持續性感染高風險 HPV 的女性被告知只能觀察與等待,監測並期望病毒自行清除。若未清除,一旦出現癌前病變,唯一的手段就是手術。如我所述,目前沒有任何一項 FDA 核准的高風險 HPV 感染藥物治療,一項也沒有,而我們正透過 ARPA-H 資助來開發一項治療。
So with that ARPA-H funding and FDA clearance of our IND application, which happened in February of this year, we are now preparing to advance DARE-HPV into a Phase II clinical study in May this month. DARE-HPV has the potential to be the first pharmaceutical therapeutic and one of the largest unaddressed infectious disease markets affecting women globally.
因此,在 ARPA-H 資助以及 FDA 對我們 IND 申請的核准(發生於今年 2 月)之下,我們正準備於本月 5 月推進 DARE-HPV 進入第二期臨床研究。DARE-HPV 有潛力成為首個藥物治療方案,並切入全球影響女性、但仍是最大未被滿足之一的感染性疾病市場。
Significant addressed market, grant-funded development, advancing into Phase II clinical development, that's exactly the kind of asset that gets rerated when investors discover it, and we believe very few have. Other potential first-in-category contraceptive candidates that we are currently developing are supported entirely with grant funding.
龐大的可服務市場、以補助金資助的開發、推進至第二期臨床開發——這正是那種當投資人發現後會被重新評價(rerated)的資產,而我們相信目前真正注意到的人非常少。我們目前正在開發的其他潛在同類首創避孕候選產品,亦完全由補助金支持。
That's DARE-LARC1, Casea S, and DARE-NHC, and they are all continuing to advance. We also have an extended NIH-funded award for DARE-PTB1, which is our bio-identical progesterone intravaginal ring candidate aiming to reduce the risk of preterm birth in at-risk women. The pipeline was deliberately built to address the most persistent gaps from preterm birth to HPV-associated disease to sexual health and beyond.
包括 DARE-LARC1、Casea S,以及 DARE-NHC,且都在持續推進。我們也獲得 NIH 延長資助,用於 DARE-PTB1——這是我們的生物同質性黃體素(bio-identical progesterone)陰道內環候選產品,目標是降低高風險女性早產的風險。我們的產品線是有意識地建立,以填補從早產、HPV 相關疾病到性健康等領域最持久的缺口,並延伸至更多需求。
And every dollar of grant funding we secure, it's a dollar that moves us closer to putting better options in the hands of women without diluting our shareholders. And I now want to speak directly to every investor on the call, institutional, retail and anyone who's listening to the replay. As I mentioned upfront, I'm joining this call from and during the National Women's Health Week in New York. And as I said upfront, the context matters.
我們取得的每一美元補助金,都是在不稀釋股東權益的前提下,讓我們更接近把更好的選擇交到女性手中。我現在想直接對電話會議上的每一位投資人——機構投資人、散戶,以及任何收聽重播的人——說幾句。如我一開始提到的,我是在紐約、於全國女性健康週期間加入這通電話會議。而如我先前所說,脈絡很重要。
Women's health is an investment-grade category, and we believe Dare is the investment-grade vehicle to capture what is still a dramatically underfunded opportunity. We're not here because it's the right week to say that, we're here because we have spent over 10 years proving it.
女性健康是一個具投資等級(investment-grade)的類別,而我們相信 Dare 是捕捉這個仍然嚴重資金不足之機會的投資等級載體。我們不是因為這一週說這些話才在這裡;我們在這裡,是因為我們用超過 10 年的時間證明了這一點。
We built the portfolio with clinical rigor, disciplined capital management and that unwavering commitment to women who have been underserved by the health care system for far, far too long. And right now, in mid-2026, we're at that moment where all that investment converges into action. The products are coming live, and we expect to record the first direct product revenue this quarter.
我們以臨床嚴謹性、嚴律的資本管理,以及對長期被醫療體系嚴重忽視的女性之堅定承諾,建立了這個產品組合。而就在 2026 年年中,我們正處於那個所有投入匯聚成行動的時刻。產品正要正式上線,我們預期本季將記錄第一筆直接產品營收。
Demand is building, the data are coming, and we're poised for partnerships. Women represent half of that global population and approximately 80% of all U.S. health care purchasing decisions are made by women. Conditions that solely affect women, the very conditions for which we are developing treatments, they're attracting less than 1% of private health care investment. Yet women's health drugs represent 27% of all blockbuster pharmaceutical products, and that's not even including GLP-1s.
需求正在累積、數據正在到來,我們也已蓄勢待發以促成合作夥伴關係。女性占全球人口的一半,而美國約 80% 的醫療保健採購決策由女性做出。僅影響女性的疾病——也正是我們正在開發治療的那些疾病——吸引到的民間醫療投資不到 1%。然而,女性健康藥物占所有重磅藥品(blockbuster)產品的 27%,這還不包含 GLP-1。
That's not a niche. That's a market failure that created a gap, and that's the gap that Dare was built to address. And I want to also address a question that we hear as we're approaching commercialization. I get asked, are we an R&D company or are we a commercial company? And I answer, yes.
那不是利基市場。那是一種市場失靈所造成的缺口,而 Dare 正是為了填補這個缺口而建立。我也想回應一個在我們接近商業化時常被問到的問題:我們是研發公司,還是商業公司?我的回答是:是的。
We're in the business of getting first-in-category products into the hands of women who need them. That requires both. We will not stop developing. We have a pipeline that includes potential first-in-category programs across contraception, APV -- HPV, hormone therapy and vaginal health, all advancing, many with nondilutive funding. That R&D engine is running.
我們的業務是把同類首創產品交到需要的女性手中。這需要兩者兼具。我們不會停止開發。我們的產品線涵蓋避孕、APV -- HPV、荷爾蒙治療與陰道健康等多個潛在同類首創計畫,皆在推進中,且許多採用非稀釋性資金支持。我們的研發引擎正在運轉。
And starting in June, that engine will be joined by a commercial engine, generating product revenue. And here is how I want investors to think about that. Product revenue is not a pivot, it's not a change of identity, it's another source of capital, and it's a value driver. Grant funding, equity financings and our product revenue, they are three distinct complementary sources of capital that together let us continue building without depending on any one of them alone.
而從 6 月開始,這個引擎將加入一個商業引擎,帶來產品營收。我希望投資人這樣看待:產品營收不是轉向,不是身分改變;它是另一個資本來源,也是價值驅動因素。補助金、股權融資與產品營收,是三個彼此區隔但互補的資本來源,合在一起讓我們能持續建設,而不必單獨依賴其中任何一項。
And we don't need to choose between R&D and commercial. We're building a company that does both because the women we're working for, they need both, the science and the products. And we intend to deliver on both fronts simultaneously.
我們不需要在研發與商業化之間二選一。我們正在打造一家兩者兼具的公司,因為我們所服務的女性需要兩者:科學與產品。我們也打算在兩個面向同時交付成果。
And here's what we're targeting to deliver, again, as a recap, DARE to PLAY dispensing. We're targeting commencement nationally this summer via Bravado as our 503B outsourcing facility partner. DARE to RESTORE, Flora Sync LF5 being the first such probiotic.
以下是我們的交付目標,作為再次回顧:DARE to PLAY 的配藥(dispensing)。我們的目標是今年夏天透過 Bravado(作為我們的 503B 外包製造設施合作夥伴)在全國範圍啟動。DARE to RESTORE,Flora Sync LF5 作為首款此類益生菌。
The seeding campaigns are beginning this month in May, the commercial launch and first product revenue is expected in June. Again, I want to reinforce an important first step in building a multiproduct revenue profile for Dare. Additional DARE to PLAY collaborations, as I said, stay tuned, commercial and telehealth collaborators to be announced as our channel infrastructure matures.
種子推廣活動將於本月 5 月開始,商業上市與首筆產品營收預計在 6 月實現。再次強調,這是 Dare 建立多產品營收版圖的重要第一步。正如我所說,更多 DARE to PLAY 的合作案,敬請期待;隨著我們通路基礎建設日趨成熟,商業與遠距醫療合作夥伴也將陸續公布。
DARE to RECLAIM dispensing, we are continuing to target 2027 for another 503B outsourcing facility with IND preparatory activities for what we've often referred to as DARE-HRT1, right, our hormone therapy product, ongoing pursuant to our dual path strategy. Ovaprene, again, I want to reiterate that second positive DSMB review just happened and was just announced this week.
關於 DARE to RECLAIM 的調劑(dispensing),我們仍以 2027 年為目標,推進另一座 503B 外包製造設施,同時依循我們的雙軌策略,持續進行我們常稱為 DARE-HRT1(也就是荷爾蒙治療產品)的 IND 前置準備工作。至於 Ovaprene,我想再次重申:第二次正向的 DSMB 審查剛剛完成,並已於本週對外宣布。
The enrollment expected to complete this year to achieve that 2,500 cycles of exposure. That puts 2027 primary endpoint analysis within reach. And as I mentioned, we do plan on FDA engagement regarding those interim findings and study protocol. And then DARE-HPV, that Phase II, we're preparing that right now with that ARPA-H funding, we're looking to start this month. So stay tuned on that.
預計今年可完成收案,以達成 2,500 個暴露週期(cycles of exposure)。這使得 2027 年進行主要終點分析(primary endpoint analysis)變得可望達成。正如我提到的,我們也計畫就這些期中發現與研究方案與 FDA 進行互動。接著是 DARE-HPV 的第二期(Phase II),我們正利用 ARPA-H 的資金進行準備,預計本月啟動,敬請期待。
And hopefully, what you get with all of that is that we are not a single event binary bet, it's a portfolio with multiple catalysts and multiple pathways to value, multiple ways to win. With every prescription written for DARE to PLAY, we're building a real-world data set. Every Ovaprene patient enrolled in our Phase III moves us closer to data that will attract partners. And every clinician who prescribes one of our products can become an advocate for the next. We're building a platform, not just a single product.
希望透過以上內容,大家能理解我們並非押注單一事件的二元結果,而是一個具備多個催化劑與多條價值實現路徑的產品組合,有多種致勝方式。每開出一張 DARE to PLAY 的處方,我們就在建立一套真實世界資料(real-world data)集。每一位納入我們第三期(Phase III)的 Ovaprene 受試者,都讓我們更接近能吸引合作夥伴的數據。而每一位開立我們其中一項產品的臨床醫師,都可能成為下一項產品的倡議者。我們正在打造的是一個平台,而不只是單一產品。
And that year of clinical data on our specific formulations, that's data that a competitor can't replicate overnight. Established and growing relationships with telehealth providers, specialty pharmacies, clinical KOLs in women's sexual health and vaginal health right now, including that clinician community we engage with at ACOG and all the groundwork we're laying for the 505(b)(2) regular pathway that we believe will provide an opportunity to protect our market position after the 503B market matures.
而針對我們特定配方所累積的一年臨床數據,是競爭對手無法在一夕之間複製的。當前我們也已與遠距醫療供應商、專科藥局、女性性健康與陰道健康領域的臨床 KOL 建立並持續深化合作關係,包括我們在 ACOG 所接觸並互動的臨床社群;同時,我們也在為 505(b)(2) 的常規途徑(regular pathway)鋪路,我們相信在 503B 市場成熟後,這將提供保護我們市場地位的機會。
And the brands, DARE to PLAY, DARE to RESTORE, DARE to RECLAIM that we're talking about right now, they're built around a clear resonant identity with women. We're operating at a moment when the cultural and commercial conversation about women's health has never been louder. The fintech and women's health services sectors are attracting serious capital.
而我們目前談到的品牌——DARE to PLAY、DARE to RESTORE、DARE to RECLAIM——都建立在與女性產生共鳴、清晰一致的品牌識別之上。我們正處於一個關鍵時點:關於女性健康的文化與商業對話聲量前所未有地高。金融科技(fintech)與女性健康服務領域正吸引大量資本投入。
Women are demanding that health care take their needs seriously. The rising tide is bringing many entrants, services, platforms, subscription models, there's real investment flowing in the category, and we think that is a good thing for awareness. And we also think it matters enormously what kind of company is doing the building. Services can be copied, subscriptions can be undercut, but clinical data, that speaks for itself. Products can be real-world solutions.
女性正在要求醫療體系嚴肅看待她們的需求。這股上升浪潮帶來許多新進者、服務、平台與訂閱模式,類別中確實有大量投資流入,我們認為這對提升認知是好事。同時,我們也認為「由什麼樣的公司來打造」至關重要。服務可以被複製,訂閱可以被削價競爭,但臨床數據會自己說話。產品可以成為真實世界的解決方案。
And we're a product company with a pipeline that is not reactive to a trend. We foresaw the trend, and it's exactly what the trend is calling for. As I said on the last earnings call, the tide is rising in women's health, and Dare has been building its pipeline at low tide. So investors want to be in before the water rises and are looking at our company right now.
而我們是一家產品公司,我們的產品線並非對趨勢的被動反應。我們預見了這個趨勢,而我們所做的正是這個趨勢所呼喚的。正如我在上一季財報電話會議所說,女性健康的潮水正在上升,而 Dare 在低潮時就已開始打造產品線。因此,投資人希望在水位上升前就先進場,並正在關注我們公司。
And with that, I'll turn it over to Mardee to give a financial review.
接下來我把時間交給 Mardee,請她進行財務回顧。
Mardee Haring-layton - Chief Accounting Officer
Mardee Haring-layton - Chief Accounting Officer
Thanks, Sabrina. Good afternoon, everyone. I'll now walk through our financial results for the quarter ended March 31, 2026, and provide context on our balance sheet and forward financial positioning. We ended the quarter with approximately $18.5 million in cash and cash equivalents and working capital of approximately $0.5 million. As a reminder, we continue to benefit from meaningful, nondilutive capital sources that help us advance our pipeline.
謝謝你,Sabrina。各位下午好。接下來我將說明截至 2026 年 3 月 31 日止季度的財務結果,並就我們的資產負債表與未來財務定位提供背景說明。本季結束時,我們持有約 1,850 萬美元的現金及約當現金,營運資金約 50 萬美元。提醒各位,我們持續受益於具實質意義、且不稀釋股權的資金來源,協助我們推進產品線。
In 2025, we received approximately $13.6 million from the Gates Foundation, $4.5 million under our ARPA-H Award and $1.3 million from NIH grant reimbursements. In February 2026, we received an additional $2 million under our ARPA-H Award. These sources have allowed us to advance multiple programs simultaneously while managing shareholder dilution responsibly.
在 2025 年,我們自蓋茲基金會(Gates Foundation)取得約 1,360 萬美元、依據 ARPA-H 獎助計畫取得 450 萬美元,並自 NIH 補助款報銷取得 130 萬美元。2026 年 2 月,我們在 ARPA-H 獎助計畫下又額外取得 200 萬美元。這些資金來源使我們能在負責任地管理股東稀釋的同時,同步推進多個專案。
Selling, general and administrative, or SG&A expenses for the first quarter of 2026 were approximately $2.2 million compared to approximately $2.3 million in the first quarter of 2025. The year-over-year decrease was primarily attributable to decreases in personnel costs, offset by increases in professional services and commercial readiness expenses, including preparations to bring DARE to PLAY and Flora Sync LF5, to market and stock-based compensation expense.
2026 年第一季的銷售、一般及行政(SG&A)費用約為 220 萬美元,較 2025 年第一季約 230 萬美元略降。年對年下降主要來自人事成本降低,但部分被專業服務費與商業化準備費用增加所抵銷,其中包括為將 DARE to PLAY 與 Flora Sync LF5 推向市場所做的準備,以及以股份為基礎的薪酬費用。
Research and development or R&D expenses were approximately $0.7 million for the first quarter of 2026 compared to approximately $2.3 million in the first quarter of 2025. I want to again highlight an important feature of our R&D expense reporting. We recognize nondilutive funding awards as contra R&D expense, meaning grant funding directly offsets our reported R&D costs.
2026 年第一季的研發(R&D)費用約為 70 萬美元,較 2025 年第一季約 230 萬美元下降。我想再次強調我們研發費用揭露的一個重要特點:我們將不稀釋股權的資助款(nondilutive funding awards)認列為研發費用的抵減項(contra R&D expense),也就是補助資金會直接抵銷我們所報告的研發成本。
Contra R&D expense related to grant funding was approximately $3.5 million for the first quarter of 2026 compared to approximately $3.1 million for the first quarter of 2025. This means our actual total R&D investment when you add back contra R&D amounts is meaningfully greater than the R&D expense line alone reflects.
與補助資金相關的研發費用抵減項(contra R&D expense)在 2026 年第一季約為 350 萬美元,2025 年第一季約為 310 萬美元。這表示,若將研發抵減項加回,我們實際的研發總投入顯著高於僅從研發費用科目所看到的數字。
We believe this is an important dynamic for investors to understand when evaluating the true scale of our R&D investment. We expect to begin recording product revenue from DARE to PLAY in the third quarter of 2026. Flora Sync LF5 consumer health product revenue is expected to begin in June 2026. We are targeting DARE to RECLAIM revenue to begin in 2027.
我們認為,投資人在評估我們研發投入的真實規模時,理解這個動態非常重要。我們預期將於 2026 年第三季開始認列 DARE to PLAY 的產品營收。Flora Sync LF5 消費者健康產品的營收預計於 2026 年 6 月開始。我們的目標是讓 DARE to RECLAIM 的營收於 2027 年開始。
We are building toward a multiproduct revenue profile that diversifies and grows across 2026 and 2027. The initiation of direct product revenue in June 2026 for the first time in the company's history is a milestone we have worked hard to reach and one that we are proud to be approaching. I want to offer a perspective on what product revenue means strategically.
我們正朝向多產品營收結構邁進,並在 2026 年與 2027 年間實現分散與成長。公司史上首次於 2026 年 6 月啟動直接產品營收,是我們努力已久、即將達成且引以為傲的里程碑。我想就「產品營收」在策略上的意義提供一些觀點。
Dare has funded its development through a combination of equity financings and nondilutive grant funding. Product revenue will add a third leg to that stool, a capital source tied directly to the value we are delivering to patients and clinicians, one that we expect to grow as our commercial footprint grows and that reinforces the development mission rather than competing with it.
Dare 的研發資金來源主要來自股權融資與不稀釋股權的補助資金。產品營收將為這張「三腳凳」增加第三隻腳——一個直接與我們為病患與臨床醫師所提供價值相連結的資金來源;我們預期它會隨著商業版圖擴大而成長,並強化研發使命,而非與之競爭。
We encourage investors to review the more detailed discussion of our financial statements, financial condition, liquidity, capital resources and risk factors in our Form 10-Q for the quarter ended March 31, 2026, filed today.
我們也鼓勵投資人查閱我們今日提交的截至 2026 年 3 月 31 日止季度 Form 10-Q,其中對財務報表、財務狀況、流動性、資本資源與風險因素有更詳細的討論。
Operator, please open the line for questions.
接線員,請開放提問。
Operator
Operator
(Operator Instructions)
(接線員指示)
Kemp Dolliver, Brookline Capital Markets.
Kemp Dolliver,Brookline Capital Markets。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
Great. A couple of questions. First, with regard to the Ovaprene trial and the interplay between enrollment phase and cycles. Sabrina, what kind of impact could this have on the timing of the readout? Just to get a sense as to whether this is a matter of just a couple of months or whether it's potentially something more significant than that? Thank you.
很好。我有幾個問題。第一個,關於 Ovaprene 試驗,以及收案階段與週期(cycles)之間的相互影響。Sabrina,這對讀出(readout)時間點可能造成多大影響?我想了解這大概只是幾個月的差異,還是可能更顯著?謝謝。
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Yeah, no, that's a fantastic question. So, if you're just doing the simple math, right, 250 women completing 13 cycles, right, that's a lot more, not a lot more, but it's more than 2,500 cycles, or 250 women completing 12 months, right, might be the easier way to do it, the math quick in your head. And so, obviously, it makes a difference.
是的,這確實是個很好的問題。所以,如果你只是做簡單的數學計算,對吧,250 位女性完成 13 個週期,對吧,那會是超過 2,500 個週期——不是多很多,但確實會超過;或者換個更容易心算的方式:250 位女性完成 12 個月。很顯然,這會造成差異。
What you're looking for with a product like this, I mean, part of the reason, right, in clinical development we have targets is you don't know what you're going to see from a safety signal, what you might see over time. Oviprine is very much a first in category product. It's the first ever once a month vaginal product, non-hormonal vaginal product that women are experiencing.
對於這類產品,你要觀察的是——我的意思是,臨床開發之所以會設定目標,部分原因在於你不知道安全性訊號會呈現什麼樣貌、以及隨時間推移可能會看到什麼。Oviprine 非常明顯是同類首創(first in category)的產品。這是女性首次體驗的「每月一次」陰道用、非荷爾蒙的陰道產品。
And so what's exciting about the data that we've seen to date, and having the DSMB look at it, is that we're not seeing a change in that safety signal over time. We're not seeing, any modifications in terms of types of adverse events or when they're happening over the course of the women that have completed the 13 cycles to date.
因此,迄今為止我們所看到的數據,以及讓 DSMB 審視這些數據令人振奮之處在於,我們沒有看到該安全性訊號隨時間出現變化。我們沒有看到不良事件類型或其發生時間點有任何改變,這是就目前已完成 13 個週期的女性受試者而言。
And so, yes, it can make a difference in terms of timing of, completing the follow-up with the women in terms of timing in 2027, right, when we could be able to target that readout. At this point, I can't give you more specific insights than that. We do want to engage with the FDA on what we've seen now because we think it's really promising and, we'd love to share it with them and get their perspective.
所以,是的,這可能會在時間安排上產生影響,例如在 2027 年完成對女性受試者的隨訪時間點,對吧,屆時我們可能可以鎖定那個讀出時間。目前我無法提供比這更具體的見解。我們確實希望就我們目前看到的結果與 FDA 進行交流,因為我們認為這非常有前景,而且我們也很希望與他們分享並聽取他們的看法。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
Okay. That's fair enough. Switching to DARE to PLAY. The launch has slipped some as we've gone along. It looks like you're now closer to the finish line. What have been the factors that have impacted the timing of getting to the point where you can do nationwide fulfillment?
好的。這樣說也合理。切換到 DARE to PLAY。隨著進展,上市時程有些延後。看起來你們現在更接近終點線了。有哪些因素影響了你們達到可進行全國履約(fulfillment)的時間點?
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Yeah. We're really trying to work closely with our partner, I refer to them as partner, but the 503B outsourcing facility, Bravado, that really is doing the work, right? They're the ones doing the manufacturing. They're the ones really that have to ensure that they're commercially ready.
是的。我們確實在努力與合作夥伴密切合作——我稱他們為合作夥伴,但實際上是 503B 外包製造機構 Bravado,真正執行工作的就是他們,對吧?他們負責製造。他們也必須確保已具備商業化準備。
And that obviously involves GMP, right, Good Manufacturing Practices, having the readiness to supply the product and meet commercial demand, obviously critical. The other piece of it, though, is state-specific registration activities that a 503B outsourcing facility is required to do. They've been doing a fantastic job with that.
而這顯然涉及 GMP,也就是優良製造規範,必須具備供應產品並滿足商業需求的準備度,這當然至關重要。不過,另一個部分是 503B 外包機構必須進行各州特定的註冊作業。他們在這方面做得非常出色。
Most 503B facilities are not registered across the country. So they have been going through that process. They're up to, I think it's 28 or so registrations at this time. So it's really balancing all of those factors. And we want to prioritize doing this right, right, and making sure that when the product becomes commercially available via the dispensing, that everything is ready on the Bravado side to ensure that they can have that quality and consistency of supply and that it's meeting the demand.
多數 503B 機構並未在全國各州完成註冊。因此他們一直在推進這個流程。目前他們已完成大約 28 個左右的註冊。所以這真的是在平衡所有這些因素。我們希望優先把事情做對,對吧,並確保當產品透過配藥(dispensing)方式正式商業化供應時,Bravado 端的一切都已就緒,以確保供應的品質與一致性,並能滿足需求。
So that's really what it's coming down to and that as many women -- when it becomes commercially available initially, that as many women across the company -- across the country can access it as possible. There are some states that simply will not allow dispensing in their state until they can review data from other states showing like shipping and quality standards. So there are some states that are going to be a little behind.
所以歸根結底就是這些因素,以及在一開始商業化供應時,讓盡可能多的女性——在全國各地——都能取得。有些州在允許其州內配藥之前,必須先審查其他州的數據,例如運輸與品質標準的證明。因此有些州的進度會稍微落後一些。
But it's -- That's all what's behind it.
但——這些就是背後的原因。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
Okay. Great. Thank you. I'll let someone else jump in.
好的。很好。謝謝你。我讓其他人接著提問。
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Thanks for the questions.
謝謝你的提問。
Operator
Operator
(Operator Instructions)
(接線員指示)
Kemp Dolliver, Brookline Capital Markets.
Kemp Dolliver,Brookline Capital Markets。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
Thanks for taking the follow-up. Just quickly, how are you thinking about the cash runway at this point?
謝謝讓我追問。簡單問一下,你們目前如何看待現金可支撐期間(cash runway)?
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Yeah. So as we said in the 10-Q when you get to the details on that, our cash, we have cash that's for grant-funded activities, right, because we have a lot of grant funding that we receive for a number of our programs and then cash that we can use for general operating activities.
是的。正如我們在 10-Q 中所說,當你看到其中細節時,我們的現金分為:用於補助金資助活動的現金,對吧,因為我們有許多計畫會收到大量補助金資金;以及可用於一般營運活動的現金。
And without the impact of obviously any of these revenue opportunities that we're talking about, if you just like looked in the vacuum at where we are on cash, we will need to raise. We don't have 12 months of capital from that perspective. And so it's always something that we're looking at.
在不考慮我們正在談論的任何營收機會影響的情況下,如果你只是在真空狀態下看我們目前的現金狀況,我們將需要募資。從那個角度來看,我們沒有 12 個月的資金。因此這一直是我們在關注的事情。
Obviously, that doesn't take into consideration the revenue inflows that we project for the products, that's just cash in hand today without any of that looking. And then also the other piece of it is the grant-funded activities, those activities, there's always kind of future disbursements that come with those grants as well.
當然,這並未把我們對產品所預估的營收流入納入考量;那只是以今天手上的現金、且不把那些因素納入來看。另外一部分是補助金資助活動,這些活動通常也會伴隨補助金的後續撥款。
So I know sometimes it's confusing when people are looking at our cash and our grant liability to try to understand where things are. Some of it's the GAAP accounting piece of it that means things don't always line up. But those are the two ways we use our capital. It's for the grant-funded activities and then it's for operations like supporting the DARE to PLAY launch, supporting DARE to RESTORE.
所以我知道,有時候大家在看我們的現金與補助金負債時,會對整體狀況感到困惑。部分原因在於 GAAP 會計處理,使得數字不一定完全對得上。但我們使用資本主要有兩種方式:用於補助金資助活動,以及用於營運,例如支持 DARE to PLAY 的上市、支持 DARE to RESTORE。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
So it's fair to say it's at least a couple -- it may not be 12 months, but it's a couple of quarters?
所以可以說至少還有幾個——可能不到 12 個月,但大概還有幾個季度?
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Yeah.
是的。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
Great. Thank you.
很好。謝謝。
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Thank you.
謝謝。
Operator
Operator
That concludes the question-and-answer session. I would like to turn the call back over to Sabrina Martucci Johnson for closing remarks. Please go ahead.
問答環節到此結束。我想把電話交回給 Sabrina Martucci Johnson 作結語。請開始。
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Sabrina Martucci Johnson - Chief Executive Officer, President, and Director
Absolutely. Thank you. Well, thank you, everyone, for participating today. As we talked a little bit about, women's health has been dismissed, it's been deprioritized, it's been underfunded for generations. And the conditions that we address at Dare, arousal, vaginal health, menopause, contraception, HPV, these affect hundreds of millions of women worldwide. They're not rare diseases. They're common experiences that have been met far too often with inadequate options, clinical dismissal or simply nothing at all.
當然。謝謝。也謝謝各位今天的參與。正如我們稍早提到的,女性健康長期以來被忽視、被降低優先順序,並且世世代代資金不足。而我們在 Dare 所關注的狀況——性喚起、陰道健康、更年期、避孕、HPV——影響全球數以億計的女性。這些不是罕見疾病,而是普遍的經驗,但太常面對的是不足的選項、臨床上的忽視,或甚至什麼都沒有。
And we're founded on the belief that women deserve better, and that belief has guided every decision we've made, including the decision to be a product company to do the hard, rigorous work of developing the clinical data and building formulations that providers and patients can trust. That choice was deliberate. And clinician and patient awareness of DARE to PLAY is growing.
我們的創立基於一個信念:女性值得更好的照護,而這個信念引導了我們做出的每一個決策,包括選擇成為一家產品公司,去做艱難且嚴謹的工作——建立臨床數據並打造讓醫療提供者與患者可以信賴的配方。這個選擇是刻意為之。而臨床醫師與患者對 DARE to PLAY 的認知正在提升。
As I mentioned, we saw those providers at ACOG who are already writing prescriptions and asking us how to stock the product in their offices. As we just mentioned, dispensing is targeted for this summer. And that -- the Flora Sync LF5, the seeding campaigns are beginning and commercial launch and first product revenues targeted for June.
如我所提到的,我們在 ACOG 看到那些已經在開立處方、並詢問我們如何在診所備貨的醫療提供者。正如我們剛剛提到的,配藥(dispensing)目標是在今年夏天。而——Flora Sync LF5 的種子推廣活動正在開始,商業上市與首批產品營收目標在 6 月。
We talked a lot about that interim data from our Ovaprene Phase III trial that we just received, that second consecutive DSMB review. And Ovaprene is a product that could be the first FDA-approved, hormone-free, monthly contraceptive. And I highlighted a few things about the pipeline behind it, which is deep and differentiated and advancing.
我們也談了很多關於我們剛收到的 Ovaprene 第三期試驗的期中數據,也就是連續第二次的 DSMB 審查。Ovaprene 可能成為第一個獲 FDA 核准、無荷爾蒙、每月使用的避孕產品。我也強調了其後方的產品線(pipeline)的一些重點:深度足、差異化明顯,且正在推進。
A commercial company and an R&D company, we're entering a phase where both are true for us simultaneously and where product revenue becomes just one more source of capital to fund the science that will produce the next generation of solutions that will, in turn, generate revenue. And that's the model working exactly as we designed it.
作為一家商業公司與一家研發公司,我們正進入一個階段:這兩者將同時成立,而產品營收也將成為另一個資本來源,用以資助科學研發;而科學研發將產出下一代解決方案,進而帶來營收。這個模式正如我們設計的那樣運作。
We built the company to change how women experience health care, and that change is beginning in earnest right now. And I just thank all of you for your confidence and for being owners. We believe the assets we hold, the catalysts ahead and the window of time we're in, represent a compelling opportunity, and we intend to execute on it.
我們打造這家公司,是為了改變女性體驗醫療照護的方式,而這個改變現在正真正開始加速。我也感謝各位的信任,以及作為股東的支持。我們相信我們所持有的資產、即將到來的催化劑,以及我們所處的時間窗口,代表一個極具吸引力的機會,而我們也打算全力執行。
And June 2026 may be the month investors look back on as the moment that we became that revenue stage company and without ever stopping being a science-driven one. So thank you for your time today, and I look forward to keeping you updated.
而 2026 年 6 月,或許會成為投資人回頭看時認為:那就是我們成為營收階段公司的一刻,同時也從未停止作為一家以科學驅動的公司。謝謝各位今天的時間,我也期待持續向各位更新進展。
Operator
Operator
Thank you so much. Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.
非常感謝。各位女士、先生,今天的電話會議到此結束。感謝各位參與。您現在可以掛線。