Dare Bioscience Inc (DARE) 2025 Q2 法說會逐字稿

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

歡迎參加由達萊生物科學治療公司 (Darré Bioscience Therapeutics Company) 主辦的電話會議，會議將報告公司 2025 年第二季的財務業績並提供業務更新。本次電話會議正在錄音中。我叫傑里科 (Jericho)，今天將由我擔任接線生。今天，達萊的嘉賓包括總裁兼首席執行官薩布麗娜·馬圖奇·約翰遜 (Sabrina Martucci Johnson) 和首席會計官瑪蒂·哈林-萊頓 (MarDee Haring-Layton)。哈林-萊頓女士，請繼續。

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

下午好，歡迎參加 Daré Bioscience 2025 年 6 月 30 日結束季度的財務業績和業務更新電話會議。今天，我們將回顧我們的財務業績，提供臨床管線的最新情況，並討論我們擴大的業務策略的持續執行。

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.

此策略包含雙軌制：一方面透過503B配製將專有配方商業化，另一方面尋求FDA批准；另一方面，將部分解決方案推廣為無需處方的品牌消費者健康產品。在所有情況下，我們的目標都是盡可能有效率、快速地將創新的女性健康解決方案推向市場。

I would like to remind you that today's discussion will include forward-looking statements within the meaning of Federal Securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-looking statements.

我想提醒大家，今天的討論將包括聯邦證券法所定義的前瞻性陳述，這些陳述是根據 1995 年私人證券訴訟改革法案的安全港條款作出的。本次電話會議中所做的任何非歷史事實陳述都應被視為前瞻性陳述。

Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended June 30, 2025, which was filed today, and our Form 10-K for the year ended December 31, 2024.

由於已知和未知的風險和不確定性，實際結果或事件可能與這些陳述中預期或暗示的結果或事件有重大差異。您不應過度依賴前瞻性陳述。前瞻性陳述完全符合公司向美國證券交易委員會 (SEC) 提交的文件中警示性聲明的規定，包括我們今天提交的截至 2025 年 6 月 30 日的季度 10-Q 表，以及截至 2024 年 12 月 31 日的年度 10-K 表。

I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, August 14, 2025. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. I will now turn it over to Sabrina.

我還想指出，本次電話會議的內容包含截至2025年8月14日為止的時效性資訊。除非法律另有規定，否則Daré不承擔更新任何前瞻性聲明以反映本次電話會議後的新資訊或進展的義務。現在，我將把發言權交給Sabrina。

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

謝謝MarDee，也謝謝今天在座的各位。 Daré正處於一個轉折點。 2025年第二季度反映了我們雙路徑策略的持續加速，我們專注於縮小女性健康領域中前景光明的科學與切實可行的解決方案之間的差距，在創造短期商業收入的同時，推動女性健康領域的長期創新。

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

我們將繼續按計畫在今年第四季透過503B外包設施支援DARE to PLAY西地那非乳膏的商業化上市。此次預期的上市不僅對Dare而言是一個重要的里程碑，對女性性健康領域而言也是如此。女性性健康領域的創新歷來落後於其他治療領域。

At the same time, we continue to advance our differentiated clinical pipeline, which includes primarily grant-funded programs, targeting areas of significant unmet need, including contraception, HPV, and preterm birth. We believe this dual-path approach enables us to unlock value efficiently by leveraging non-dilutive capital and a disciplined investment strategy. Let me walk you through several highlights across our portfolio.

同時，我們持續推動差異化臨床管線，主要包括由撥款資助的項目，瞄準避孕、HPV和早產等亟待滿足的重大需求領域。我們相信，這種雙軌制模式能夠讓我們利用非稀釋性資本和嚴謹的投資策略，有效率地釋放價值。接下來，我將為您介紹我們投資組合中的幾個亮點。

First, DARE to PLAY Sildenafil cream, a near-term revenue opportunity. We remain on track to support a fourth quarter 2025 launch of -- (technical difficulty)

首先，DARE to PLAY 西地那非乳膏，這是一個短期收入機會。我們仍有望支持在2025年第四季推出…（技術難度）

I'm going to jump in here because we're having some technical difficulties. As Sabrina said, we remain on track to support a Q4 2025 launch of DARE to PLAY via a 503B outsourcing facility. This channel allows us to accelerate patient access to our proprietary formula while discussions with the FDA continue on defining acceptable endpoints for a future FDA registration path.

我得插播一下，因為我們遇到了一些技術難題。正如Sabrina所說，我們仍在按計劃透過503B外包服務支援DARE to PLAY在2025年第四季的上市。這個管道讓我們能夠加快患者獲得我們專有配方的速度，同時我們仍在與FDA繼續討論，以確定未來FDA註冊路徑的可接受終點。

In partnership with Rosy Wellness, we launched the first phase of our direct-to-patient awareness campaign. Feedback from this early effort reinforces the significant interest and unmet need in supporting women with arousal concerns.

我們與Rosy Wellness合作，啟動了第一階段的直接面向患者的認知宣傳活動。這項早期行動的回饋進一步印證了人們對支持女性性喚起問題的濃厚興趣，以及尚未滿足的需求。

On August 6, Daré hosted a provider-oriented webinar titled the DARE to PLAY Difference, The Sildenafil Cream That Raises the Bar in partnership with the National Association of Nurse Practitioners in Women's Health. This session featured renowned experts, Dr. Irwin Goldstein, Founding Editor of the Journal of Sexual Medicine; Sue Goldstein, former President of the International Society for the Study of Women's Sexual Health and Certified Sexual Educator; and Rose Hartzell-Cushanick, an AASECT-certified Sex Therapist.

8月6日，Daré與美國女性健康執業護理師協會（NAPHR）合作，舉辦了一場醫療服務提供者的網路研討會，主題為「DARE to PLAY 的差異：提升標準的西地那非乳膏」。本次研討會邀請了多位知名專家，包括《性醫學雜誌》創始編輯Irwin Goldstein博士、國際女性性健康研究學會前主席、認證性教育家Sue Goldstein，以及AASECT認證性治療師Rose Hartzell-Cushanick。

The discussion explored DARE to PLAY's formulation science, clinical evidence showing improved genital blood flow and arousal outcomes and critical clinician insights on why DARE to PLAY Sildenafil cream would set a new standard in women's arousal -- women's sexual arousal healthcare. The replay is available at daretoplaybio.com.

這次討論探討了 DARE to PLAY 的配方科學、臨床證據（表明其可改善生殖器血流和性喚起效果），以​​及臨床醫生對 DARE to PLAY 西地那非乳膏為何能為女性性喚起——女性性喚起醫療保健——樹立新標準的關鍵見解。重播可在 daretoplaybio.com 觀看。

This is a large under-recognized market where the promise of Sildenafil, the same active ingredient in an oral erectile dysfunction drug, is recognized, but the clinical evaluation of topical Sildenafil formulations has been lacking. We, therefore, believe DARE to PLAY Sildenafil cream is positioned to be the first meaningful prescription innovation in this category.

這是一個尚未被充分認識的龐大市場，其中西地那非（一種口服勃起功能障礙藥物的活性成分）的前景已得到認可，但外用西地那非製劑的臨床評估卻一直缺乏。因此，我們相信 DARE to PLAY 西地那非乳膏將成為該領域首個具有重大意義的處方創新產品。

We are excited about its potential as a near-term revenue driver. Please visit www.daretoplaybio.com for updates and access alerts so that you can be among the first to know when the only evidence-based Sildenafil cream formulation DARE to PLAY Sildenafil cream becomes available.

我們對其作為短期收入成長點的潛力感到興奮。請造訪 www.daretoplaybio.com 獲取最新資訊和提醒，以便第一時間了解唯一基於實證醫學的西地那非乳膏配方 DARE to PLAY 西地那非乳膏的上市時間。

Next on to Ovaprene Phase 3 trial update. Turning to Ovaprene, our potential first-in-category, hormone-free monthly contraceptive candidate. We announced this quarter that the independent Data and Safety Monitoring Board, or DSMB, reviewed interim data from the Phase 3 study and recommended that the trial continue as planned.

接下來是 Ovaprene 三期臨床試驗的更新。我們即將推出的 Ovaprene 是我們潛在的同類首創、無荷爾蒙月經避孕候選藥物。本季度，我們宣布獨立數據與安全監測委員會 (DSMB) 審查了三期研究的中期數據，並建議試驗按計劃繼續進行。

There were no new safety or tolerability concerns or serious safety concerns identified, and the interim pregnancy rate of women treated in the study was consistent with our expectations based on our prior postcoital test study of Ovaprene.

沒有發現新的安全性或耐受性問題或嚴重的安全性問題，研究中接受治療的女性的中期懷孕率與我們根據先前對 Ovaprene 進行的性交後測試研究所預期的一致。

These data support Ovaprene's potential to fill a significant gap in the contraception landscape, providing women with a non-hormonal user-controlled option without daily intervention. With millions of women in the US seeking effective hormone-free birth control, Ovaprene has the potential to address a significant unmet need and transform the contraceptive landscape. We look forward to the completion of the study and the final analysis of study endpoints, including the primary endpoint of pregnancy rate calculated using the Pearl Index.

這些數據表明，Ovaprene 有望填補避孕領域的重大空白，為女性提供無需每日幹預、使用者自主控制的非荷爾蒙避孕方案。鑑於美國數百萬女性正在尋求有效的無激素避孕方法，Ovaprene 預計將滿足一項尚未滿足的重大需求，並徹底改變避孕領域。我們期待研究的完成以及研究終點的最終分析，包括使用 Pearl 指數計算的懷孕率這一主要終點。

Recall that Bayer received the right to obtain exclusive US rights to commercialize the product following completion of the pivotal clinical trial if Bayer in its sole discretion, makes a $20 million payment to Daré. Daré may receive up to $310 million in commercial milestone payments, plus double-digit tiered royalties on net sales. The potential $20 million payment and royalty payments are subject to a third party's minority interest under royalty purchase agreement entered into in April 2024.

回顧一下，如果拜耳自行決定向達雷支付2000萬美元，拜耳將獲得在關鍵臨床試驗完成後在美國獨家商業化該產品的權利。達雷可能獲得高達3.1億美元的商業里程碑付款，以及兩位數的淨銷售額分級特許權使用費。根據2024年4月簽訂的特許權使用費購買協議，這2000萬美元的潛在付款和特許權使用費將取決於第三方的少數股權。

Next, DARE-HRT1 dual commercialization pathway. We are also excited to update you on DARE-HRT1, our proprietary intravaginal ring designed to deliver bio-identical estradiol and progesterone for monthly hormone therapy.

接下來是DARE-HRT1雙商業化途徑。我們也很高興向您介紹DARE-HRT1的最新進展，這是我們專有的陰道環，旨在為每月一次的荷爾蒙治療提供生物同質的雌二醇和孕酮。

We are pursuing both a traditional FDA approval path and a 503B compounding opportunity similar to our dual-path strategy for Sildenafil cream. We believe this approach allows us to accelerate patient access while continuing to generate the data necessary to seek FDA approval and support long-term value creation.

我們正尋求既有傳統的FDA審批路徑，又有503B複合機會，類似我們西地那非乳膏的雙路徑策略。我們相信，這種方法能夠加快患者用藥速度，同時持續產生申請FDA批准所需的數據，並支持長期價值創造。

DARE-HRT1 will be a unique solution in the estimated $4.5 billion compounded hormone therapy market, and we believe it could generate meaningful revenue alongside DARE to PLAY Sildenafil cream. We are targeting its availability via a 503B outsourcing facility in late 2026.

DARE-HRT1 將成為價值約 45 億美元的複合荷爾蒙治療市場中獨一無二的解決方案，我們相信它能夠與 DARE to PLAY 西地那非乳膏一起創造可觀的收入。我們計劃於 2026 年底透過 503B 外包服務提供此產品。

Next, vaginal probiotics represent our consumer health expansion. In parallel with our prescription portfolio, we are preparing to launch two non-prescription vaginal probiotics designed to support vaginal microbiome health.

接下來，陰道益生菌代表著我們消費者健康的擴展。除了處方產品組合外，我們正準備推出兩款非處方陰道益生菌，旨在支持陰道微生物群的健康。

At Daré, we believe women deserve access to the highest quality evidence-based products. Our goal is simple, to bridge the innovation gap and ensure that women have access to the tools to support their intimate health.

在 Daré，我們相信女性值得擁有最高品質的實證產品。我們的目標很簡單：彌補創新差距，確保女性能獲得維護私密健康的工具。

To that end, we seek to leverage innovative science-backed vaginal health approaches developed in Europe and already being used by women in countries where they are available. We look forward to bringing those products to women in the United States.

為此，我們致力於利用歐洲研發的、以科學為支撐的創新陰道保健方法，這些方法已在已涵蓋這些方法的國家被女性廣泛使用。我們期待將這些產品帶給美國女性。

These products will complement our prescription offerings and represent an important diversification of our commercial platform. We anticipate introducing them following the launch of DARE to PLAY, so please stay tuned to learn more later this year.

這些產品將補充我們的處方藥產品，並代表我們商業平台的重要多元化。我們預計將在 DARE to PLAY 推出後推出這些產品，敬請期待今年稍後的更多詳情。

Grant-funded clinical programs, innovation through efficiency. We continue to advance programs supported entirely by nondilutive funding awards. DARE-HPV is in development as a novel intravaginal therapy for persistent high-risk HPV infection. The program is currently funded through an ARPA-H award and NIH grant.

受資助的臨床項目，以效率驅動創新。我們持續推進完全由非稀釋性資助計畫支持的計畫。 DARE-HPV 正在開發中，旨在作為一種針對持續性高風險 HPV 感染的新型陰道內療法。該計畫目前由美國高級研究計劃局 (ARPA-H) 和美國國立衛生研究院 (NIH) 資助。

DARE-LARC1 is a preclinical stage long-acting contraceptive intended to offer multiyear protection with remote pause/resume control. A $6 million grant installment was received just last month. These programs target significant unmet needs and further differentiate our pipeline in women's health.

DARE-LARC1 是一種臨床前階段的長效避孕藥，旨在提供多年保護，並具備遠端暫停/恢復控制功能。上個月剛收到一筆 600 萬美元的撥款。這些項目旨在滿足尚未滿足的重大需求，並進一步凸顯了我們在女性健康領域的產品線差異化。

And now on to review the financial results for the recently completed quarter. I'd now like to summarize Daré's financial results for the quarter ended June 30, 2025, which I will refer to as the second quarter. We ended the quarter with approximately $5 million in cash and cash equivalents, and working capital deficit of approximately $12.6 million.

現在，我們來回顧一下最近結束的季度財務業績。現在，我想總結一下達萊截至2025年6月30日的季度（我稱之為第二季）的財務表現。本季末，我們的現金和現金等價物約為500萬美元，營運資金缺口約1,260萬美元。

After quarter end, we received approximately $17.6 million in net proceeds from sales of our common stock and a $6 million grant payment. This additional capital significantly strengthens our balance sheet, enhancing our ability to execute on our dual-path strategy.

季度末後，我們透過出售普通股獲得了約1,760萬美元的淨收益，並獲得了600萬美元的補助金。這筆額外資本顯著增強了我們的資產負債表，增強了我們執行雙路徑策略的能力。

G&A expenses were $2.4 million compared to $2.5 million in Q2 2024. The year-over-year change was primarily due to decreases in personnel costs, stock-based compensation expense, and general corporate overhead, partially offset by an increase in professional services expense.

一般及行政費用為 240 萬美元，而 2024 年第二季為 250 萬美元。年比變化主要是由於人事成本、股票薪酬費用和一般公司管理費用的減少，但專業服務費用的增加部分抵消了這一變化。

R&D expenses were $1.4 million, a 71% decrease versus Q2 2024, primarily due to an increase in contra R&D expenses or reductions to R&D expenses that we recognized due to non-dilutive funding awards as well as decreases in manufacturing costs related to Ovaprene and development costs related to Sildenafil cream, partially offset by increases in costs related to development activities for other clinical and preclinical R&D programs, including DARE-HPV and DARE-LARC1.

研發費用為 140 萬美元，較 2024 年第二季下降 71%，主要原因是由於非稀釋性資金獎勵導致的對銷研發費用增加或研發費用減少，以及與 Ovaprene 相關的製造成本和與西地那非乳膏相關的開發成本減少，但部分被與其他臨床和臨床前研發活動所增加的成本所增加的成本減少，但部分被與其他臨床和臨床前研發活動（包括 D-AREH1）的開發成本增加。

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

我們鼓勵投資者查看我們今天提交的截至 2025 年 6 月 30 日的季度 10-Q 表中有關我們的財務報表、財務狀況、流動性、資本資源和風險因素的更詳細討論。

Due to technical difficulties, we will not be able to hold the Q&A session today. So I will turn it back over to the operator.

由於技術故障，我們今天無法舉行問答環節。因此，我將把問題交還給接線員。

Thank you. And since there's no Q&A and that concludes our conference call for today. Thank you so much for joining, and you may now disconnect.

謝謝。由於沒有問答環節，我們今天的電話會議到此結束。非常感謝您的加入，現在您可以掛斷電話了。