Release Details
Daré Bioscience Reports First Quarter 2026 Financial Results and Provides Business Update
Company Highlights Second Positive DSMB Review of Interim Data from Ovaprene® Phase 3 Clinical Trial, DARE to PLAY™ Anticipated Dispensing Commencement and Flora Sync LF5™ Commercial Launch Summer 2026; First Product Revenue Expected in
Conference Call and Webcast Today at
“We are hosting our financial results and business update call from
“Daré is a product company. Its mission is to develop and bring to market clinically-studied and differentiated women’s health products – products with clinical data behind them, addressing gaps where in our view little to no adequate options exist today. The DARE Health Hub and its telehealth infrastructure are built to put those products in women’s hands efficiently and discreetly. Telehealth is an access tool; the products are the point. We believe product revenue from these commercially launched products, alongside capital raised through equity financing and non-dilutive grant funding, will give Daré a complementary capital structure to continue developing the next generation of first-in-category solutions for women,” continued
2026 FIRST QUARTER BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS
DARE to PLAY™ Sildenafil Cream
DARE to PLAY is a first-of-its-kind topical sildenafil cream for women. To the company’s knowledge, there is no other sildenafil cream manufactured under current Good Manufacturing Practice (cGMP) requirements with clinical data demonstrating increased genital blood flow in 10 to 15 minutes, and improvement in arousal, orgasm, and desire measured by clinically-validated and FDA-reviewed endpoints. An estimated 20 million women in
While there is not yet an FDA-approved therapy, DARE to PLAY was designed to fill that void. Daré is making DARE to PLAY available as a Section 503B compounded product.¹
- Daré participated in the
American College of Obstetricians and Gynecologists (ACOG) annual conference during the first quarter of 2026, generating interest from the healthcare provider community. - The provider community’s response at ACOG reinforces Daré’s belief that DARE to PLAY addresses a significant, long-standing unmet need in women’s sexual health, and that clinician advocacy will be a key driver of commercial momentum.
Dispensing Anticipated to Commence Summer 2026
- Pre-fulfillment prescribing has been available nationwide in all 50 states since
February 11, 2026 , with women accessing DARE to PLAY through the DARE Health Hub.2 Bravado Pharmaceuticals , the 503B-registered outsourcing facility for DARE to PLAY, is targeting the commencement of national dispensing this summer, in the third quarter of 2026, as Bravado advances state licensing and fulfillment preparations.- Product differentiation: To Daré’s knowledge, DARE to PLAY is the only clinically studied sildenafil cream for women, demonstrated to increase genital blood flow within approximately 10 minutes of application and manufactured in accordance with FDA’s cGMP regulations, which better ensure consistent potency and quality.
- Dual-path strategy: While making DARE to PLAY available as a 503B compounded product, Daré is simultaneously working to advance its sildenafil cream formulation toward the 505(b)(2) NDA pathway.3
- Product-first commercial model: Daré’s commercial approach is built around the differentiation of its products, not around a services or subscription model. The DARE Health Hub and telehealth access are infrastructure designed to connect women efficiently to Daré’s products. The company’s provider-focused strategy reflects this priority: clinicians who prescribe DARE to PLAY are prescribing a specific, clinically studied formulation.
- Daré’s 503B commercial model is asset-light in that it’s built around targeted digital awareness campaigns, telehealth access through the DARE Health Hub, and
Medvantx fulfillment infrastructure. As the commercial channel matures, Daré will look to add strategic collaborations with additional telehealth platforms, platform distributors, and clinical networks.
DARE to RESTORE™ — First Product Revenue Milestone Approaching
Daré is building the DARE to RESTORE brand family of consumer health products designed to support vaginal microbiome balance. The company’s first DARE to RESTORE product, Flora Sync LF5™ – a vaginal probiotic suppository developed by Probiotical, one of the world’s leading probiotic research companies – is expected to launch commercially in
- First product revenue milestone: The anticipated commencement of Flora Sync LF5 sales in
June 2026 is expected to mark the first time Daré Bioscience will record direct product revenue – a historic milestone for the company. - Seeding campaigns begin in May: Ahead of the commercial launch, Daré is initiating seeding campaigns in
May 2026 to build clinician awareness and drive initial consumer trial. - Product differentiation: The Flora Sync LF5 formulation is based on scientific research into vaginal microbiome composition and health, has been studied in a 100-person human clinical trial, and findings have been published in a peer-reviewed journal. Probiotical is the exclusive manufacturer using its proprietary LF5 probiotic strain. Daré believes this level of clinical evidence distinguishes Flora Sync LF5 from the majority of vaginal probiotic suppositories on the market today.
- Daré intends to distribute Flora Sync LF5 through the DARE Health Hub as a complement to its 503B prescription offerings. The company expects to continue exploring opportunities to expand the DARE to RESTORE product line through additional collaborations with Probiotical.
DARE to RECLAIM™ — Monthly Bio-Identical Hormone Therapy
DARE to RECLAIM, a proprietary monthly intravaginal ring (IVR) formulation of bio-identical 17β-estradiol and bio-identical progesterone (known as DARE-HRT1), is designed to be a non-oral, monthly, hormone therapy product – targeting the estimated
Daré is targeting to have DARE to RECLAIM available for prescription fulfillment in the
Ovaprene® — Investigational Hormone-Free Monthly Intravaginal Contraceptive
On
- Approximately 9% of women treated in the study had experienced a pregnancy, consistent with the company’s expectations based on the results of the pre-pivotal postcoital test clinical study of Ovaprene.
- No new types of adverse events or tolerability concerns were identified. Neither an increase in the frequency of adverse events nor the emergence of new types of adverse events was observed with prolonged Ovaprene use. No serious adverse events related to the study device were identified.
- Approximately 12% of participants discontinued the study due to vaginal odor, the most commonly reported product-related adverse event, a 5% decrease compared to data reviewed by the DSMB in
July 2025 . - User acceptance: A majority of participants who had completed the study reported they would be very likely or likely to use Ovaprene if it became available.
- Data basis: The DSMB reviewed data from 339 study subjects contributing 1,789 menstrual cycles of safety data, representing a meaningful proportion of the study’s 2,500-cycle target.
- Enrollment timing: The study protocol calls for at least 2,500 cycles of exposure and at least 250 subjects completing 13 menstrual cycles of use. Based on current enrollment trends, the company expects to achieve 2,500 cycles of exposure before 250 subjects complete 13 menstrual cycles of use. The company believes the interim safety data may support the sufficiency of fewer than 250 subjects completing 13 menstrual cycles of use to evaluate Ovaprene’s safety profile. The company intends to engage with FDA regarding these findings. The company currently expects to complete enrollment sufficient to achieve at least 2,500 cycles of exposure in 2026. Completing enrollment in 2026 would put the primary endpoint analysis within reach in 2027.
DARE-HPV — Potential First Therapeutic for High-Risk HPV Infection
DARE-HPV is Daré’s investigational therapeutic candidate targeting high-risk human papillomavirus (HPV) infection, the underlying cause of virtually all cervical cancer cases in
With ARPA-H funding and FDA clearance of the company’s IND application in
Additional Pipeline Programs
Daré continues to advance a broad pipeline of women’s health programs supported substantially by non-dilutive grant funding, including:
- DARE-PTB1: A bio-identical progesterone intravaginal ring candidate targeting reduction of preterm birth risk in at-risk women, supported by an extended funding award from the
National Institutes of Health (NIH) announced inMarch 2026 . - DARE-LARC1, Casea S4, and DARE-NHC: Programs for development of potential first-in-category contraceptive candidates, advancing entirely with grant funding, including activities to identify and develop a novel non-hormonal intravaginal contraceptive candidate suitable for women in low- and middle-income country settings.
POTENTIAL CATALYSTS
Daré is targeting the following milestones in 2026 and 2027:
- DARE to PLAY dispensing to commence in summer 2026 as Bravado completes state licensing and fulfillment preparations
- Additional commercial and telehealth collaborations for DARE to PLAY as the commercial channel matures, building on strong clinician engagement at ACOG
- Flora Sync LF5 (DARE to RESTORE product family) commercial launch in
June 2026 , with first product revenue expected at that time, marking an important first step in building a multi-product revenue profile - DARE to RECLAIM dispensing to commence in 2027, with IND application preparatory activities for DARE-HRT1 ongoing pursuant to the company’s dual-path strategy
- Ovaprene Phase 3 clinical study– second positive DSMB review of interim data announced
May 12, 2026 ; enrollment expected to complete in 2026 to achieve at least 2,500 menstrual cycles of exposure, putting a 2027 primary endpoint analysis within reach; company intends to engage with FDA regarding study protocol - DARE-HPV advancing into Phase 2 clinical study in
May 2026 with ARPA-H funding
“Daré is not a single-event binary bet. This is a portfolio with multiple potential catalysts, multiple pathways to value, and multiple ways to win. With our upcoming revenue milestones, we are now frequently asked whether Daré is now a commercial company or an R&D company. The answer is yes to both, and we believe that’s a strength. As a product company, we develop clinically-studied and differentiated solutions and work to get them into the hands of women and the providers who care for them via the fastest eligible pathways to market. Product revenue is not a pivot away from our science. It is an additional source of capital that reinforces it. Grants. Equity financings. And now product revenue. Three legs of a capital structure to enable building without depending on any one source alone,” said
¹ Compounded drug products are not approved by the
² The pre-fulfillment prescription period for DARE to PLAY is the timeframe during which women may complete a telehealth consultation or in-person clinician visit and have a prescription written and received at
3 Reference to the 505(b)(2) NDA pathway refers to Section 505(b)(2) of the FDCA, which enables an applicant to rely, in part, on the FDA’s prior findings of safety and efficacy data for an existing product, or published literature, in support of its new drug application (NDA).
4 Casea S is being evaluated in a Phase 1 clinical trial sponsored by FHI 360 (NCT05174884), with the support of a private foundation grant. Daré is not currently developing this asset but may exercise rights to do so in
FINANCIAL RESULTS FOR FIRST QUARTER 2026 AND HIGHLIGHTS
Cash Position
As of
Revenue
Revenue of approximately
Cost of Revenues
Cost of revenues for the three months ended
Operating Expenses
Selling, general and administrative expenses were approximately
R&D expenses were approximately
Revenue Outlook
Daré expects to begin recording product revenue from DARE to PLAY this summer, in the third quarter of 2026. Flora Sync LF5 consumer health product revenue is expected to begin in
Daré encourages investors to review the detailed discussion of its financial statements, financial condition, liquidity, capital resources, and risk factors in its Quarterly Report on Form 10-Q for the quarter ended
CONFERENCE CALL
Daré will host a conference call and live webcast today,
To access the conference call via phone, dial (646) 307-1963 or (800) 715-9871 (toll free). The conference ID number for the call is 2531472. The live webcast can be accessed under “Presentations, Events & Webcasts” in the Investors section of the company’s website at http://ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast will be archived under the same section of the company’s website and available for replay until
ABOUT DARÉ BIOSCIENCE
Daré Bioscience is a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions. Every innovation Daré advances is based in advanced science and backed by rigorous, peer-reviewed research. From contraception to menopause, pelvic pain to fertility, vaginal health to infectious disease, Daré is working to close critical gaps in care using science that serves her needs.
For decades, women have been told to “wait it out” or “live with it,” while innovations that could improve their quality of life languish in the regulatory or funding pipeline. With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting. However, access to real, evidence-based solutions continues to lag. Daré was founded to change that. As a female-led health biotech company, Daré is accelerating the development of credible, science-based solutions that meet the high standards of clinical rigor – randomized, controlled trials; validated endpoints; peer-reviewed publications; and current Good Manufacturing Practice (cGMP) requirements.
To learn more about Daré’s mission to deliver differentiated therapies for women and its innovation pipeline, please visit www.darebioscience.com.
Daré may announce material information about its finances, products and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com),
FORWARD-LOOKING STATEMENTS
Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “positioned,” “pursue,” “seek,” “execute,” “prepare,” “should,” “would,” “target,” “on track,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Daré’s go-to-market strategies; Daré’s plans and timing for making solutions for women available by prescription in the
CONTACTS
Daré Bioscience Investor Relations
innovations@darebioscience.com
Source: Daré
Daré
| Daré |
|||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||
| (Unaudited) | |||||||
| Three Months Ended |
|||||||
| 2026 | 2025 | ||||||
| Revenue | |||||||
| Research and development services and royalty revenue | $ | 152,455 | $ | 25,427 | |||
| Total revenue | 152,455 | 25,427 | |||||
| Cost of revenues | 242,325 | - | |||||
| Operating expenses | |||||||
| Selling, general and administrative | 2,248,566 | 2,309,164 | |||||
| Research and development | 660,462 | 2,297,381 | |||||
| Total operating expenses | 2,909,028 | 4,606,545 | |||||
| Loss from operations | (2,998,898 | ) | (4,581,118 | ) | |||
| Other (expense) income | (991 | ) | 202,811 | ||||
| Net loss | $ | (2,999,889 | ) | $ | (4,378,307 | ) | |
| Foreign currency translation adjustments | 44,542 | 13,090 | |||||
| Comprehensive loss | $ | (2,955,347 | ) | $ | (4,365,217 | ) | |
| Loss per common share - basic and diluted | $ | (0.20 | ) | $ | (0.50 | ) | |
| Weighted average number of shares outstanding: | |||||||
| Basic and diluted | 14,522,835 | 8,759,053 | |||||
| Daré |
|||||||
| Condensed Consolidated Balance Sheets Data | |||||||
(unaudited) |
|||||||
| Cash and cash equivalents | $ | 18,519,784 | $ | 24,711,356 | |||
| Working capital | $ | 540,124 | $ | 3,378,192 | |||
| Total assets | $ | 27,828,414 | $ | 32,474,563 | |||
| Total stockholders' equity | $ | 734,451 | $ | 2,842,634 | |||
Source: Daré Bioscience, Inc.
