Full Press Release Details
Bioscience Reports Third Quarter 2024 Financial Results and Provides Company Update
Call and Webcast Today at 4:30 p.m. ET
Program Highlights and Anticipated Milestones
| Ovaprene hormone-free monthly intravaginal contraceptive candidate - pivotal Phase 3 contraceptive efficacy study recruiting across the United States; foundation grant announced yesterday will provide funding to allow Dar to expand the number of clinical sites to accelerate the development timeline | |
| Sildenafil Cream, 3.6% topical formulation of sildenafil being developed to treat female sexual arousal disorder - continued operational progress toward a planned Phase 3 study, including constructive discussions with FDA; Phase 3 design, development, and collaboration strategy updates | |
| DARE-HPV proprietary, fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment of human papillomavirus (HPV)-related cervical diseases - conducting activities necessary to enable submission of an IND application to the FDA for a Phase 2, randomized, placebo-controlled, double-blind clinical study of DARE-HPV for clearance of high-risk HPV infection in women, which will be supported with funding Dar receives as an ARPA-H Sprint for Women's Health $10 million awardee | |
| DARE-VVA1 proprietary formulation of tamoxifen for intravaginal administration being developed as a hormone-free alternative to estrogen-based therapies for the treatment of moderate-to-severe dyspareunia, or pain during sexual intercourse - conducting activities in preparation for a Phase 2 clinical study of DARE-VVA1 based on Dar 's FDA-cleared IND | |
| DARE-PTB1 intravaginal ring designed to deliver bio-identical progesterone continuously for up to 14 days for the prevention of preterm birth - conducting activities necessary to enable submission of an IND application to the FDA for a Phase 1 clinical study, which will be supported by a $2 million grant from NICHD | |
| Foundation grant of up to approximately $10.7 million to fund activities related to the identification and development of a novel non-hormonal intravaginal contraceptive product candidate and to add additional clinical sites to accelerate the ongoing Ovaprene pivotal study. |
DIEGO November 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 September 30, 2024 and provided a company update.
continue to be excited about the increased attention on the health and wellbeing of women, including by the Advanced Research Projects
Agency for Health (ARPA-H) as evidenced by their recent announcement related to the awardees of the ARPA-H Sprint for Women's
Health and our announcement of the $10 million award we were selected to receive for DARE-HPV, an innovative investigational
treatment for HPV-related cervical diseases. Essentially all cervical cancer cases worldwide are caused by HPV infection. We are also
very pleased by the foundation's continued commitment to invest in the development of non-hormonal contraceptive methods as evidenced
by the grant we announced yesterday of up to approximately $10.7 million to fund activities related to our identification and development
of a novel non-hormonal intravaginal contraceptive product candidate and to add additional clinical sites to accelerate the ongoing Ovaprene
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. 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 continue to advance our first-in-category Phase 3 development
candidates with ongoing enrollment in our Phase 3 study of Ovaprene at sites across the U.S., and continued constructive interactions
with the FDA focused on aligning on the Phase 3 program for Sildenafil Cream 3.6% in female sexual arousal disorder. Despite its high
prevalence, there are currently no FDA-approved treatments for female sexual arousal disorder and we look forward to advancing this program
into Phase 3. Additionally, we are conducting activities in preparation for a Phase 2 clinical study of DARE-VVA1 and a Phase 1 study
of DARE-PTB1, which is supported by a $2 million grant from NICHD," said Sabrina Martucci Johnson, President and CEO of Dar
progress across our portfolio, along with the $10.7 million grant agreement announced yesterday, the $10 million award from ARPA-H announced
in October, the $15 million equity line arrangement we established with Lincoln Park Capital Fund, LLC in October, and the $22 million
we secured in the non-dilutive strategic royalty financing in the second quarter, put Dar on track for meaningful milestones
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 U.S. Food and Drug Administration (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 do so.
is currently proceeding at 10 sites across the United States, supported by a central advertising campaign for the study that launched
in March 2024. Based on the current average enrollment rate, Dar anticipates that approximately half of its target
number of participants to complete the study, or 125 women, will complete approximately 6 months of product use by the end of the second
quarter of 2025. The foundation grant announced yesterday will provide funding to allow Dar to expand the number of clinical
sites recruiting in the study, which is intended to accelerate the overall development timeline.
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 (FSAD).
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 proposed to the FDA for Phase
3 clinical development were those where Dar 's exploratory post-hoc analyses of the Phase 2b study data showed that Sildenafil
Cream demonstrated statistically significant and meaningful patient improvement. Ongoing discussions with the FDA are focused on aligning
on primary and secondary patient reported outcome endpoints for the Phase 3 studies as well as other data that might be required for
a new drug application (NDA) submission. Based on FDA feedback Dar has received, two successful Phase 3 clinical studies
of Sildenafil Cream will be required to support an NDA for Sildenafil Cream for the treatment of FSAD, and Dar anticipates
that each Phase 3 study will be approximately $15.0 million in direct costs. Dar will take into account its capital resources
before initiating a Phase 3 study.
planned initial 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 Phase 3 program, as well as relevant updates
on the initial Phase 3 study timing and Dar 's collaboration strategy as they become available.
Highlights for the Quarter ended September 30, 2024
| Cash and cash equivalents: $11.2 million at September 30, 2024. | ||
| General and administrative expenses: $2.0 million in 3Q-2024 as compared to $2.7 million in 3Q-2023, with the current quarter's decrease primarily attributable to reduced professional services expense and reduced commercial readiness expenses. | ||
| Research and development expenses: $2.7 million in 3Q-2024 as compared to $6.7 million in 3Q-2023, a 60% decrease compared to Q3-2023, with the current quarter's decrease primarily attributable to a decrease in costs related to development activities for Sildenafil Cream as a result of the Phase 2b RESPOND clinical study completion in June 2023, partially offset by increases in costs related to Ovaprene's development, including the ongoing pivotal Phase 3 clinical trial. |
will host a conference call and live webcast today, November 14, 2024, at 4:30 p.m. Eastern Time to review financial results for the
quarter ended September 30, 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 6400145. 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 November 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, sexual health, pelvic pain, fertility,
infectious diseases, and menopause.
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 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 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 2022. In 2023,