Full Press Release Details
Bioscience Reports Second 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 continued operational progress toward a planned Phase 3 study; additional FDA feedback forthcoming; Phase 3 design, development, and collaboration strategy updates |
DIEGO August 12, 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 June 30, 2024 and provided a company update.
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. Enrollment
in our Phase 3 study of Ovaprene, our potentially first-in-category hormone-free monthly intravaginal contraceptive candidate, is ongoing
at sites across the U.S. and we continue to see a robust response to the central advertising campaign that went live in March. We are
continuing our interactions with the FDA regarding the Phase 3 program for Sildenafil Cream 3.6% in female sexual arousal disorder.
While we await additional FDA feedback, we have been performing operational activities to support the planned Phase 3 program.
Despite its high prevalence, there are currently no FDA-approved treatments for female sexual arousal disorder," said
Sabrina Martucci Johnson, President and CEO of Dar Bioscience. "The progress across our portfolio, along with the $22 million
we secured in the non-dilutive strategic royalty financing we announced in the second quarter, puts Dar on track for meaningful
milestones in 2024. In addition, we are excited about the increased attention on the health and wellbeing of women, including by grant
making agencies, 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
is currently underway at 20 sites across the United States, supported by a central advertising campaign for the study that launched in
March 2024. Phase 3 study updates will be provided as relevant throughout 2024. Based on the current average enrollment rate across the
20 study sites, we anticipate that approximately half of our 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.
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.
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. Dar continues to interact with the FDA
on the development program for Sildenafil Cream as a treatment for female sexual arousal disorder, and is awaiting additional feedback
from the FDA on the proposed endpoints, as well as additional information on data that may be needed in an NDA submission to appropriately
qualify any ingredient (other than sildenafil) for the vaginal route of administration. Dar also requested clarification on the
safety database (size and duration exposure) that the FDA will require for an NDA submission. Initiating a Phase 3 study is contingent
on aligning with the FDA regarding the foregoing. Based on FDA feedback we have 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 we anticipate that each Phase
3 study will cost approximately $15.0 million. We will take into account our 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 June 30, 2024
| Cash and cash equivalents: $16.4 million at June 30, 2024. In April 2024, Dar received $22 million in gross proceeds in a non-dilutive royalty monetization transaction with XOMA (US) LLC and a $1 million payment as the latest installment under an up to $49 million grant agreement with a foundation in support of nonclinical development of the investigational contraceptive, DARE-LARC1. To date, Dar has received approximately $29.3 million under the DARE-LARC1 grant agreement. | ||
| General and administrative expenses: $2.4 million in 2Q-2024 as compared to $2.9 million in 2Q-2023, with the current quarter's decrease primarily attributable to reduced headcount and reduced professional services expense. | ||
| Research and development (R&D) expenses: $4.9 million in 2Q-2024 as compared to $6.0 million in 2Q-2023, a 19% decrease compared to Q2-2023, with the current quarter's decrease primarily attributable to decreases in costs related to development activities for Sildenafil Cream as a result of the Phase 2b RESPOND clinical study completion in June 2023 and decreases in costs related to development activities for our other programs, offset by increases in costs related to our ongoing pivotal Phase 3 clinical trial of Ovaprene. |
will host a conference call and live webcast today, August 12, 2024, at 4:30 p.m. Eastern Time to review financial results for the quarter
ended June 30, 2024 and to provide a company update.
access the conference call via phone, dial (646) 307-1952 (U.S.) or (888) 672-2415 (toll free). The conference ID number for the call
is 6756565. 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 August 26, 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