Full Press Release Details
Bioscience Reports First Quarter 2024 Financial Results and Provides Company Update
Call and Webcast Today at 4:30 p.m. ET
Program Highlights and Anticipated 2024 Milestones
| Ovaprene hormone-free monthly intravaginal contraceptive candidate pivotal Phase 3 contraceptive efficacy study recruiting across the United States | ||
| Sildenafil Cream, 3.6% topical formulation of sildenafil being developed to treat female sexual arousal disorder successful completion of end-of-Phase 2 meeting with FDA; forthcoming additional FDA feedback; Phase 3 design, development, and collaboration strategy updates |
DIEGO May 14, 2024 (GLOBE NEWSWIRE) -- Dar Bioscience, Inc. (NASDAQ: DARE), a leader in innovation
for the health and wellbeing of women, today reported financial results for the quarter ended March 31, 2024 and provided a company update.
progress across our portfolio in the first quarter, along with the $22 million we secured in the non-dilutive strategic royalty financing
we announced a couple of weeks ago, puts Dar on track for meaningful milestones in 2024," said Sabrina Martucci Johnson,
President and CEO of Dar Bioscience. "In
addition to the continued commercialization by our collaborator Organon of XACIATO (clindamycin phosphate) vaginal gel 2%, the
first FDA-approved product to emerge from our portfolio and a treatment for bacterial vaginosis in females aged 12 and older* that is
available by prescription nationwide, we are pleased with the progress of our first-in-category Phase 3 development candidates. We continue
to enroll our Phase 3 study of Ovaprene, our potentially first-in-category hormone-free monthly intravaginal contraceptive candidate,
at sites across the U.S. and are thrilled with the response to the central advertising campaign that went live in March. We are also
progressing toward a Phase 3 trial of Sildenafil Cream 3.6% in female sexual arousal disorder, for which there are currently
no FDA-approved treatments. We are excited about the increased attention in the media, government, and grant making agencies on the
health and wellbeing of women, and continue to execute on our mission to accelerate development of and bring to market innovative
treatments that women want and need by advancing our late-stage candidates - all of which represent a first-in-category opportunity
- as we seek to deliver value for all Dar stakeholders."
see below for important safety and other information.
is a novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement
with Bayer HealthCare.
with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the
National Institutes of Health (NIH) and commercial collaborator Bayer, Dar commenced patient enrollment in the Ovaprene
pivotal Phase 3 clinical study in December 2023. Non-hormonal contraception represents a significant commercial market opportunity, and
there are currently no monthly, hormone-free contraceptives approved by the FDA. Ovaprene has potential to be a disruptive product
in the contraceptive category and an important option for women who cannot use hormone-based birth control products or prefer not to
is currently underway at 18 sites across the United States, supported by a central advertising campaign for the study that launched in
March 2024. Phase 3 study recruitment and data updates will be provided as relevant throughout 2024.
Cream, 3.6% Progress toward Phase 3 Study
Cream is a proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra , for topical on-demand
administration to treat female sexual arousal disorder.
has completed all study analyses of data from the exploratory Phase 2b RESPOND clinical study and held an end-of-Phase 2 meeting with
the FDA in December 2023. In prior quantitative studies, Sildenafil Cream increased genital tissue blood flow, and the Phase 2b at-home
study was specifically designed to identify the patient population that experienced the most meaningful improvement from Sildenafil Cream
and the questions to ask them that best reflect that improvement. The patient population and the endpoints identified in the Phase 2b
study and proposed to the FDA for Phase 3 clinical development were those where Dar 's post-hoc analyses of the Phase 2b
study data showed that Sildenafil Cream demonstrated statistically significant and meaningful patient improvement. Dar is continuing
to interact with the FDA as the FDA reviews, specifically, the data generated on the proposed endpoints to take forward into Phase 3
development. The FDA has indicated it anticipates providing additional feedback on the Phase 3 design in 2Q-2024.
planned Phase 3 study of Sildenafil Cream, 3.6% would be the first ever Phase 3 pivotal study of a therapeutic candidate for the treatment
of arousal disorder in women. Dar intends to provide updates on the FDA's feedback, Phase 3 study design and plans, as
well as any relevant updates on Dar 's collaboration strategy as available in 2024.
Highlights for the Quarter ended March 31, 2024
will host a conference call and live webcast today, May 14, 2024, at 4:30 p.m. Eastern Time to review financial results for the quarter
ended March 31, 2024 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 5582540. 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 "Presentations, Events & Webcasts" in
the Investors section of the company's website at http://ir.darebioscience.com and available for replay until May 28, 2024.
XACIATOTM (clindamycin phosphate) vaginal gel 2%
is indicated for the treatment of bacterial vaginosis in females 12 years and older. A single-dose user-filled disposable applicator
delivers 5g of vaginal gel containing 100mg of clindamycin.
is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin.
difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range
in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over 2 months
after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C.
difficile may need to be discontinued.
condoms are not recommended during treatment with XACIATO or for 7 days following treatment. During this time period, polyurethane condoms
may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Latex
or polyisoprene condoms should be used.
may result in the overgrowth of Candida spp. in the vagina resulting in vulvovaginal candidiasis, which may require antifungal treatment.
most common adverse reactions reported in >2% of patients and at a higher rate in the XACIATO group than in the placebo group were
vulvovaginal candidiasis and vulvovaginal discomfort.
has not been studied in pregnant women. However, based on the low systemic absorption of XACIATO following the intravaginal route of
administration in nonpregnant women, maternal use is not likely to result in significant fetal exposure to the drug.
are no data on the effect of clindamycin on milk production. The developmental and health benefits of breastfeeding should be considered
along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin
or from the underlying maternal condition.
see the Prescribing Information, Patient Information, and Instructions for Use.
Bioscience is a biopharmaceutical company committed to advancing innovative products for women's health. The company's mission
is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and
well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health,
menopause, sexual health and fertility.
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. Organon commenced U.S. marketing of XACIATO in the
fourth quarter of 2023. 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 Viagra , 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 XACIATO, Dar 's full portfolio of women's health product candidates, and Dar 's 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 2022. In 2023,
Dar 's CEO was 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. Dar Bioscience placed #1 in the Small Company category of the San
Diego Business Journal's 2023 Best Places to Work Awards.
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,"