Full Press Release Details
Bioscience Reports Third Quarter 2025 Financial Results and Provides Corporate Update
to PLAY Sildenafil Cream on Track to Launch Before Year End via 503B Pathway, Paving the Way for Near-Term Product Revenue
Interim DSMB Outcome for Ovaprene Phase 3 Study Supports Continued Enrollment
Grant-Funded Programs Advance, Including to Address HPV and Long-Acting as well as Non-Hormonal Contraception
Commercially Available Solutions for Women Expected Over the Next Two Years
| In addition to DARE to PLAY Sildenafil Cream , Commercialization of DARE to RESTORE Vaginal Probiotics in the Consumer Health Market Targeted to follow DARE to PLAY Sildenafil Cream availability and DARE to RECLAIM Monthly Hormone Therapy via 503B Compounding Pathway Targeted for Early 2027 | ||
| DARE to RECLAIM Will Establish Entry into the Estimated $4.5 Billion Compounded Hormone Therapy Market While Dar Continues Building Toward FDA-Approval Opportunity |
Call Today at 4:30 p.m. ET
2025 Highlights; Near-Term Revenue and Long-Term Value Creation Through Dual-Path Execution:
| On track for initial prescription fulfillment in December through a 503B-registered outsourcing facility | ||
| November 17th webinar to feature leading clinicians discussing clinical data and potential impact in women's sexual health; Registration and Access: https://cvent.me/KO1obd | ||
| Represents near-term revenue generation opportunity and an important proof point for the Company's 503B compounding strategy |
| Independent data safety monitoring board (DSMB) reviewed interim safety data in July 2025 and recommended the pivotal Phase 3 multicenter, single-arm, open-label study (ClinicalTrials.gov ID # NCT06127199) continue without modification | ||
| Interim pregnancy rate of women treated in the study was consistent with the Company's expectations based on prior postcoital test study of Ovaprene | ||
| Enrollment in the study is ongoing; primary endpoint is assessment of typical use pregnancy rate over 13 menstrual cycles (Pearl Index) |
| DARE-HPV : Currently funded by an ARPA-H award and NIH grant; in development as a novel intravaginal therapy to treat persistent high-risk genital human papillomavirus (HPV) infections in women and reduce risk of cervical disease | ||
| DARE-LARC1 : Preclinical development expected to be fully funded by a foundation grant; investigational long-acting contraceptive intended to offer multi-year protection with remote pause/resume capability; $6 million grant installment received in July 2025 and $4 million grant installment received in October 2025 | ||
| DARE-NHC : A preclinical research program that will aid in the identification and development of a novel non-hormonal intravaginal contraceptive product candidate. The grant funding supports activities to de-risk the development of a novel non-hormonal intravaginal contraceptive, suitable for and acceptable to women in low- and middle-income country settings who need or would prefer to use such a product to avoid an unplanned pregnancy. A $3.6 million installment under a November 2024 grant agreement is anticipated to be received in November 2025. |
| DARE to RESTORE : Targeted for availability in the first quarter of 2026, two non-prescription vaginal probiotics designed to support vaginal microbiome health, intended to be complementary to Dar 's prescription offerings | ||
| DARE to RECLAIM : Proprietary monthly bio-identical estradiol and progesterone intravaginal ring targeted to be available for prescription fulfillment in early 2027 via the 503B compounding pathway to accelerate patient access; Dar is continuing in parallel on pathway to seek FDA approval of DARE-HRT1 for the treatment of moderate-to-severe vasomotor symptoms due to menopause, conducting activities to enable submission of an Investigational New Drug (IND) application to the FDA for a pivotal Phase 3 clinical study. |
DIEGO, November 13, 2025 (GLOBE NEWSWIRE) - Dar Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company
solely focused on closing the gap in women's health between promising science and real-world solutions, today reported financial results
for the quarter ended September 30, 2025 and provided a company update.
is executing a disciplined, multi-pronged value creation strategy - preparing to generate revenue from DARE to PLAY Sildenafil
Cream beginning in December, while advancing a pipeline that spans both clinical innovation and near-term commercial solutions,"
said Sabrina Martucci Johnson, President and CEO of Dar Bioscience.
"With four women's health products expected to become commercially available over the next two years, and multiple grant-supported
programs, we believe Dar is well positioned to deliver meaningful impact for women and strong value creation for shareholders."
health remains an underfunded and underserved market - and we believe the coming weeks will represent a historic inflection point
for Dar and for women seeking new options. We are proud to lead with science, collaboration, and purpose," stated Johnson.
Highlights for the Quarter Ended September 30, 2025
| Cash Position: As of September 30, 2025, Dar had approximately $23.1 million in cash and cash equivalents, and working capital of approximately $3.8 million. | ||
| General and Administrative Expenses: $2.5 million in Q3 2025 compared to $2.0 million in Q3 2024, with the year-over-year change primarily attributable to increases in professional services expense and commercial-readiness expenses driven by execution against the Company's expanded business strategy, which includes earlier market access for select proprietary solutions via 503B compounding and bringing to market non-prescription consumer health products. | ||
| Research and Development (R&D) Expenses: $1.2 million in Q3 2025 compared to $2.7 million in Q3 2024, reflecting a decrease of 56%, primarily due to an increase in contra R&D expenses (reductions to R&D expenses due to non-dilutive funding awards), as well as decreases in manufacturing costs related to Ovaprene and in personnel costs, partially offset by increases in costs related development activities for other clinical- and preclinical-stage R&D programs, including DARE-HPV, DARE-LARC1, Sildenafil Cream, 3.6%, DARE to PLAY Sildenafil Cream, and DARE-PTB1. |
to Section 503B, 503B, 503B compounding, 503B compounding pathway, and similar terms refer to Section 503B of the Federal Food, Drug,
and Cosmetic Act (FDCA) and the production and supply of compounded drugs by Section 503B-registered outsourcing facilities without patient-specific
prescriptions in accordance with Section 503B. Dar encourages investors to review the more detailed discussion of its financial
condition, results of operations, liquidity, capital resources, and risk factors included in its Form 10-Q for the quarter ended September
30, 2025, filed today with the U.S. Securities and Exchange Commission (SEC).
will host a conference call and live webcast today, November 13, 2025, at 4:30 p.m. Eastern Time to review its financial results for
the quarter ended September 30, 2025 and to provide a company update.
access the conference call via phone, dial (646) 307-1963 or (800) 715-9871 (toll free). The conference ID number for the call is 5794075.
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 November
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 Dar 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, Dar is working to close critical
gaps in care using science that serves her needs.
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. Dar was founded to change that.
As a female-led health biotech company, Dar 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.
learn more about Dar 's mission to deliver differentiated therapies for women and its innovation pipeline, please visit
Bioscience leadership has been named on the Medicine Maker's Power List and Endpoints News' Women in Biopharma and Dar 's
CEO has been honored as one of Fierce Pharma's Most Influential People in Biopharma for Dar 's contributions to innovation
and advocacy in the women's health space.
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), SEC filings, press releases, public conference calls and webcasts. Dar
will use these channels to distribute material information about the company and may also use social media to communicate important information
about the company, its finances, products and product candidates, clinical trials and other matters. The information Dar posts
on its investor relations website or through social media channels may be deemed to be material information. Dar encourages investors,
the media, and others interested in the company to review the information Dar posts in the Investors section of its website and
to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels
the company may use to communicate information will be posted in the Investors section of Dar 's website.
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 Dar 's go-to-market strategies; Dar 's plans and timing for making solutions
for women available by prescription in the U.S. as compounded drugs via Section 503B or without a prescription as branded consumer health
products; the market opportunity for those products and their ability to gain market acceptance; expected timing of revenue from sales
of those products; Dar 's intent to continue to pursue an FDA approval pathway for those product candidates it brings to
market under Section 503B; plans and expectations with respect to Dar 's product candidates, including clinical development
plans, trial design, timelines, costs, milestones, targeted indications, clinical trials and results, regulatory strategy, and U.S. Food
and Drug Administration (FDA) communications, submissions and review of applications; the clinical potential of and market opportunities
for Dar 's product candidates; Ovaprene's potential to be the first FDA-approved hormone-free intravaginal monthly
contraceptive; the importance of the DSMB's recommendation and the interim results from the ongoing Phase 3 clinical study of Ovaprene
to Dar and Ovaprene; expectations regarding existing collaborations; the sufficiency of non-dilutive grant and other financial
award funding to advance development of specified product candidates or programs, including through specified milestones; Dar 's
ability to meaningfully impact women and create value for its shareholders; and the potential impact of DARE to PLAY Sildenafil Cream
for Dar and women. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause
Dar 's actual results, performance or achievements to be materially different from future results, performance or achievements
expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties
related to: Dar 's reliance on Section 503B-registered outsourcing facilities and other third parties to bring DARE to PLAY
Sildenafil Cream and other solutions to market as compounded drugs or as consumer health products and facilitate access to such products
and the risk that those third parties do not perform as expected; difficulties in establishing and sustaining relationships with third-party
collaborators; the risk that the FDA could stop permitting Section 503B-registered outsourcing facilities to compound the drug substances
in the proprietary formulations Dar intends to bring or brings to market or changes the conditions under which those drug substances
may used in compounding or the compounded products may be distributed; the ability of Dar 's outsourcing facility partners
to maintain their registration with the FDA under Section 503B; the timing of establishing, and ability to maintain, state-required licensure
or registration to enable fulfillment of prescriptions for DARE to PLAY Sildenafil Cream and other solutions brought to market
via the Section 503B pathway; Dar 's inexperience, as a company, in and lack of infrastructure for commercializing products;
the degree of market demand and acceptance for the products Dar brings to market; competitive product launches; greater than
expected costs to bring compounded drug products to market and marketing costs; shifts in consumer spending or behavior; Dar 's
ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; Dar 's
dependence on grants and other financial awards from governmental entities and a private foundation; limitations on Dar 's
ability to raise additional capital through sales of its common stock or other equity securities due to restrictions under SEC and Nasdaq
rules and regulations or contractual limitation; Dar 's reliance on third parties to manufacture and conduct clinical trials
and preclinical studies of its product candidates and commercialize XACIATO (clindamycin phosphate) vaginal gel 2% and future
FDA-approved products, if any; the risk that the current regulatory pathway known as the FDA's 505(b)(2) pathway for drug product
approval in the U.S. is not available for a product candidate as Dar anticipates; Dar 's ability to develop, obtain
FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay
in starting, conducting and completing clinical trials of a product candidate and the inherent uncertainty of outcomes of clinical trials;
Dar 's ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established