Full Press Release Details
Bioscience Reports First Quarter 2025 Financial Results and Provides Company Update
addition to its proprietary Sildenafil Cream formulation, Dar is taking action to make three other solutions for women available
commercially, two vaginal probiotics in 2025 and its proprietary monthly hormone therapy in 2026
Creates commercial opportunity in the estimated up to $4.5 billion compounded hormone therapy market, enabling women to access an evidence-based solution
Four on-market products will accelerate revenue generation and provide path to profitability
Dar expects to start recording revenue in the 4th quarter of this year
call today at 4:30 p.m. ET to discuss the further expanded business strategy to commercialize multiple solutions in 2025 and 2026
Cream, 3.6% an investigational topical formulation of sildenafil being developed to treat female sexual arousal disorder, targeting
availability via prescription as a Section 503B compounded drug this year
an investigational monthly intravaginal hormone therapy being developed to treat the vasomotor symptoms of menopause, targeting availability
via prescription as a Section 503B compounded drug next year
probiotics, designed to restore a healthy vaginal microbiome, targeting availability as branded consumer health products this year
a novel, investigational hormone-free monthly intravaginal contraceptive; enrollment ongoing in pivotal Phase 3 contraceptive efficacy
study; data safety monitoring board interim assessment scheduled for July 2025
DIEGO May 13, 2025 (GLOBE NEWSWIRE) - Dar Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company driven by a mission
to challenge the status quo, making women's health a priority, today reported financial results for the quarter ended March 31,
2025 and provided a company update.
first quarter of 2025 has been marked by distractions and disruptions for the overall healthcare and biotech sector. I am proud that
Dar is uniquely positioned to cut through the noise and deliver value to all of our stakeholders - women, healthcare providers,
and investors. Today, biopharmaceutical companies with relatively low risk assets, a competitive advantage and a path toward near-term
revenue are positioned to offer upside. We believe that is Dar today," said Sabrina Martucci Johnson, President and
CEO of Dar Bioscience. "Women's health is ripe for returns because it has been underfunded and fragmented -
and with our recently announced expanded business strategy, we believe we are uniquely positioned to deliver value and returns to all
of our stakeholders, with a business model that is nimble, allowing us to rapidly commercialize multiple products via multiple channels.
We are no longer only seeking FDA approval; we are leveraging a dual path strategy where we commercialize via 503B compounding while
continuing to seek FDA approval. We are also taking steps toward launching certain solutions as branded consumer health products that
do not require a prescription."
our knowledge, we are the only publicly traded company focused solely on developing therapeutic products for a broad range of conditions
affecting women - contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. And,
to our knowledge, we are the only publicly traded company leveraging all available paths to bring evidence-based solutions to market,
reflecting where and how women are getting and paying for their care - as an FDA-approved treatment, as a compounded product, as
a consumer health product that does not require a prescription - available via telehealth, online, or via an in-person visit with
her healthcare provider. Our portfolio is compelling and over the next months we look forward to providing updates regarding strategic
partnerships and collaborations to facilitate access to Dar on-market brands for women across multiple channels," said
Development Pipeline Highlights
a novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement
with Bayer HealthCare.
Cream, 3.6%, a proprietary, investigational cream formulation of sildenafil, the active ingredient in an oral erectile dysfunction
drug for men, for topical on-demand administration to treat female sexual arousal disorder (FSAD).
a proprietary, investigational fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment
of human papillomavirus (HPV)-related cervical diseases.
Highlights for the Quarter ended March 31, 2025
encourage investors to review the more detailed discussion of our financial statements, our financial condition, liquidity, capital resources,
and risk factors in our quarterly report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC today.
will host a conference call and live webcast today, May 13, 2025, at 4:30 p.m. Eastern Time to review financial results for the quarter
ended March 31, 2025 and to provide a company update.
access the conference call via phone, dial (646) 307-1963 (U.S.) or (800) 715-9871 (toll free). The conference ID number for the call
is 3461324. 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 May 27, 2025.
Bioscience is a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority. Dar
believes that innovation does not have to start from scratch. The company's goal is to bring to market as soon as practicable innovative
evidence-based solutions that address decades of unmet needs in women's health and enhance outcomes and convenience, primarily
in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. The potential
products Dar identifies, in many cases, already have clinical proof of concept or existing safety data for the active ingredient
that the company leverages. This provides optionality and flexibility, in many cases, in how Dar seeks to bring solutions to
market in ways designed to optimize access for women in a fiscally responsible manner.
first FDA-approved product to emerge from Dar 's portfolio of women's health product candidates is XACIATO
(clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients
12 years of age and older, which is under a global license agreement with Organon. Visit www.xaciato.com for information about XACIATO.
Dar 's portfolio also includes potential first-in-category candidates in clinical development: Ovaprene , a novel, hormone-free
monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel
cream formulation of sildenafil, the active ingredient in an oral erectile dysfunction drug for men, to treat female sexual arousal disorder
(FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn
more about Dar 's full portfolio of women's health product candidates and mission to deliver differentiated therapies
for women, please visit www.darebioscience.com.
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, product 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, product 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," "predict," "seek," "should," "would,"
"contemplate," "project," "target," "objective," "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 its proprietary formulations
available by prescription in the U.S. as compounded drugs via Section 503B of Federal Food, Drug, and Cosmetic Act (FDCA) and for launching
branded consumer health products; the market opportunity for those products and their ability to gain market acceptance; expected timing
of revenue from sales and that such sales will provide a path to profitability for Dar ; 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; potential strategic partnerships
and third-party collaborations; expectations regarding existing collaborations; and the amount and timing of Dar 's receipt
of funds under grant agreements. As used in this press release, "first-in-category" is a forward-looking statement relating
to the potential of a product candidate to represent a new category of product if it were to receive marketing approval for the indication
for which it is being developed because Dar believes it would address a need in women's health that is not being met by
existing FDA-approved products. 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 ability to raise additional capital when and as needed to execute its business strategy and continue
as a going concern; the risk of delisting of Dar 's common stock from Nasdaq; the effects of macroeconomic conditions, geopolitical