Dare Bioscience (NASDAQ:DARE) said it is preparing to enter a new phase as a revenue-generating company while continuing to advance a women’s health development pipeline supported in part by non-dilutive funding.
On a conference call reviewing first-quarter 2026 results, President and Chief Executive Officer Sabrina Johnson said the company expects its first direct product revenue to begin in June with the launch of Flora Sync LF5, a vaginal probiotic suppository under the DARE to RESTORE brand. The company is also targeting the start of national dispensing for DARE to PLAY, its sildenafil topical cream for women, this summer through a 503B outsourcing facility partner.
Company outlines dual-path commercialization strategy
Dare said it is pursuing what it described as a dual-path approach: making certain proprietary formulations available through 503B compounding while also advancing products toward potential FDA approval. Chief Accounting Officer MarDee Haring-Layton said the company uses the term 503B compounding to refer to drug products compounded 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.
Johnson emphasized that Dare views itself as a product company rather than a telehealth or subscription platform. She said the DARE Health Hub and telehealth access are intended to help put products in patients’ hands, but “the products are the point.”
DARE to PLAY, a sildenafil topical cream intended to address female arousal challenges, has been available for pre-fulfillment prescribing across all 50 states since February 2026, Johnson said. She cited clinician interest at the American College of Obstetricians and Gynecologists annual conference, including providers asking about stocking the product in their offices.
Dispensing has not yet begun. Johnson said Bravado, the 503B-registered outsourcing facility for DARE to PLAY, is targeting dispensing this summer as it completes state licensing and fulfillment preparations. In response to an analyst question, Johnson said Bravado had approximately 28 state registrations at the time of the call and that some states may require data from other states before allowing dispensing.
Flora Sync LF5 expected to mark first direct product revenue
Johnson said Flora Sync LF5 is expected to launch commercially in June 2026, with clinician awareness and consumer trial campaigns beginning in May. She said this would mark the first time Dare records direct product revenue.
Flora Sync LF5 is a vaginal probiotic suppository developed by Probiotical and based on research into vaginal microbiome composition and health, according to Johnson. She said the product has been studied in a 100-person clinical trial, with findings published in a peer-reviewed journal.
The company expects DARE to RESTORE products to be distributed through the DARE Health Hub and positioned as complementary to its prescription offerings.
Ovaprene trial continues after second DSMB review
Dare also highlighted its ongoing Phase 3 trial of Ovaprene, a monthly hormone-free intravaginal contraceptive candidate. Johnson said an independent data safety monitoring board recommended the study continue without modification for the second time after reviewing interim data.
According to Johnson, interim data showed that approximately 9% of women treated in the study had experienced a pregnancy, a rate she said was consistent with the company’s expectations based on earlier results and the prior DSMB review. She said no new types of adverse events or tolerability concerns were identified, and no serious adverse events related to the study device were observed.
Johnson said approximately 12% of participants discontinued due to vaginal odor, the most commonly reported product-related adverse event, down by 5 percentage points compared with the data reviewed by the DSMB in July 2025. She also said a majority of participants who completed the study reported they would be very likely or likely to use Ovaprene if it became available.
The trial protocol calls for at least 2,500 cycles of exposure and 250 subjects completing 13 menstrual cycles of use. Johnson said current enrollment trends suggest the company expects to achieve the 2,500-cycle exposure target before 250 subjects complete 13 cycles. Dare intends to engage with the FDA regarding the interim findings and the study protocol. The company expects to complete enrollment sufficient to achieve at least 2,500 cycles of exposure in 2026, which Johnson said could put the primary endpoint analysis within reach in 2027.
Pipeline updates include hormone therapy and HPV programs
Johnson said Dare continues to target 2027 for 503B prescription fulfillment of DARE to RECLAIM, its proprietary monthly intravaginal ring designed to deliver bioidentical estradiol and progesterone. The company is also pursuing activities to support an NDA filing and a pivotal Phase 3 clinical study for the product.
Dare is also preparing to advance DARE-HPV into a Phase 2 clinical study in May 2026, Johnson said. She said the program, supported by ARPA-H funding, received FDA clearance of its investigational new drug application in February.
Other programs cited on the call included grant-funded contraceptive candidates DARE-LARC1, Casea S3 and DARE-NHC, as well as DARE-PTB1, a bioidentical progesterone intravaginal ring candidate being developed to reduce the risk of preterm birth in at-risk women.
Cash, expenses and runway
Haring-Layton said Dare ended the first quarter with approximately $18.5 million in cash and cash equivalents and working capital of about $500,000. She said the company received approximately $13.6 million from the Gates Foundation, $4.5 million under its ARPA-H award and $1.3 million from NIH grant reimbursements in 2025. In February 2026, Dare received an additional $2 million under its ARPA-H award.
First-quarter selling, general and administrative expenses were approximately $2.2 million, down from approximately $2.3 million in the prior-year quarter. Haring-Layton said the decrease was primarily due to lower personnel costs, partially offset by increases in professional services, commercial readiness expenses and stock-based compensation.
Research and development expenses were approximately $700,000 in the first quarter, compared with approximately $2.3 million a year earlier. Haring-Layton said Dare records non-dilutive funding awards as contra R&D expense, directly offsetting reported R&D costs. Contra R&D expense related to grant funding was approximately $3.5 million in the quarter, compared with approximately $3.1 million in the first quarter of 2025.
In the question-and-answer session, Johnson said that excluding potential revenue inflows and future grant disbursements, the company does not have 12 months of capital on hand and will need to raise capital. Asked whether the current runway was at least a couple of quarters, Johnson replied, “Yes.”
Dare said it expects DARE to PLAY product revenue to begin in the third quarter of 2026, Flora Sync LF5 revenue to begin in June 2026 and DARE to RECLAIM revenue to begin in 2027.
About Dare Bioscience (NASDAQ:DARE)
Dare Bioscience, Inc is a clinical-stage biopharmaceutical company focused on developing innovative therapies for women’s reproductive health. The company’s flagship development candidate is Ovaprene, a monthly, self-administered, non-hormonal contraceptive vaginal ring designed to offer an alternative to traditional hormone-based birth control methods. Through its proprietary intravaginal drug delivery platform, Dare seeks to address unmet medical needs in gynecology and contraception with products that prioritize efficacy, safety and ease of use.
In addition to its lead contraceptive program, Dare is advancing a pipeline of early-stage assets aimed at treating gynecologic conditions through local, non-systemic drug delivery.
