Full Press Release Details
Bioscience Reports Full Year 2023 Financial Results and Provides Company Update
Call and Webcast Today at 4:30 p.m. ET
Highlights and Anticipated 2024 Milestones
| XACIATO (clindamycin phosphate) vaginal gel 2% is available by prescription in the United States to treat bacterial vaginosis under license agreement with commercial collaborator Organon | |
| 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 March 28, 2024 (GLOBE NEWSWIRE) - Dar Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation,
today reported financial results for the year ended December 31, 2023 and provided a company update.
are pleased with the incredible progress we made in 2023 with our late-stage candidates and on-market product, including the U.S. launch
of XACIATO , Sildenafil Cream Phase 2b study completion and Ovaprene Phase 3 study commencement, which put us on track for meaningful
milestones in 2024 across multiple programs. In addition, we are excited about the increased attention that women's health has
received more broadly," said Sabrina Martucci Johnson, President and CEO of Dar Bioscience. "I had the pleasure of
attending in person both the ARPA-H Sprint for Women's Health announcement event in Boston in February and the White House reception
in March in honor of Women's History Month where President Biden signed an executive order dedicated to advancing women's
health research, and it is encouraging to see further, comprehensive action aimed at increasing investments in women's health.
They bring focus to and financial support for the entire ecosystem working to boldly innovate for women. We look forward to continuing
to execute on our mission to accelerate development of and bring to market innovative treatments that women want and need, and to evaluate
a wide range of financing opportunities to fund our robust portfolio. Our 2023 achievements demonstrate our commitment to advancing our
late-stage candidates - all of which represent a first-in-category opportunity - while seeking to continue to deliver value
for all Dar stakeholders."
2023, Dar announced the first shipment of XACIATO in connection with its launch in the United States, had 15 interactions
with the U.S. Food and Drug Administration (FDA) across six product candidates / indications, commenced the Phase 3 clinical study for
its hormone-free monthly intravaginal contraceptive candidate Ovaprene, completed the Phase 2b study of its investigational Sildenafil
Cream product for female sexual arousal disorder and the Phase 1 study of its investigational vaginal diclofenac product DARE-PDM1 for
menstrual pain, and received IND clearance for DARE-VVA1, its hormone-free candidate for sexual pain.
U.S. Launch Underway
(clindamycin phosphate) vaginal gel 2% is indicated for the treatment of bacterial vaginosis in female patients 12 years of age and
older. Please see below for important safety and other information.
vaginosis is the most common vaginal condition in women of reproductive age in the United States, affecting approximately 23 million
women. The condition results from an overgrowth of certain bacteria, which upsets the balance of the natural vaginal microbiome and can
lead to symptoms of odor and discharge. Bacterial vaginosis may self-resolve in up to 30% of women, but most symptomatic women require
treatment. If left untreated, bacterial vaginosis may lead to serious complications. Bacterial vaginosis has also been shown to disproportionately
affect non-Hispanic Black and Mexican American women.
October 16, 2023, Dar announced the first shipment of XACIATO in connection with its launch in the U.S., triggering a
$1.8 million first commercial milestone payment from collaborator Organon. XACIATO provides a new therapeutic option for the millions
of women suffering from bacterial vaginosis in the U.S. On January 10, 2024, Organon announced that XACIATO is available nationwide by
prescription to treat bacterial vaginosis.
an on-market product, XACIATO represents a non-dilutive source of revenue for Dar . Dar is eligible to receive double
digit royalties based on net sales and up to $180 million in potential milestone payments from Organon. Quarterly revenue and launch
updates will be provided throughout 2024.
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 17 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.
Data for Sildenafil Cream, 3.6%
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 feedback, Phase 3 study design and plans, as well as
any relevant updates on its collaboration strategy as available in 2024.
proprietary, investigational formulation of diclofenac for intravaginal administration to treat menstrual cramping pain (dysmenorrhea).
December 2023, Dar announced positive topline results from the Phase 1 study evaluating the pharmacokinetics (PK), safety, and
exploratory efficacy of DARE-PDM1. DARE-PDM1 is an investigational product designed to deliver diclofenac, a nonsteroidal anti-inflammatory
drug (NSAID), vaginally via the company's proprietary hydrogel to treat primary dysmenorrhea, which is defined as painful menstruation
in women with normal pelvic anatomy. DARE-PDM1 has the potential to be a first-in-category product, delivering diclofenac in a convenient
vaginal format that may extend the duration of menstrual pain relief provided by and reduce the risks associated with the oral delivery
of NSAIDs. Based on the positive results, Dar is evaluating next steps in the development program.
proprietary, investigational formulation of tamoxifen for intravaginal administration to treat sexual pain (dyspareunia) in women without
the use of hormones.
December 2023, Dar announced that the FDA cleared its investigational new drug (IND) application for DARE-VVA1, a novel intravaginal
proprietary formulation of tamoxifen being developed as a non-hormonal treatment option for moderate to severe dyspareunia, a symptom
of vulvar and vaginal atrophy (VVA) associated with menopause. Products containing estrogen are commonly used to treat VVA, but some
women cannot or choose not to use these products, including those with a history of hormone-receptor positive (HR+) breast cancer.
the IND clearance from the FDA, Dar can begin planning for an anticipated Phase 2 randomized, double-blinded, placebo-controlled,
dose-finding clinical study of DARE-VVA1. Such planning and preparatory activities are underway.
Highlights for the Year Ended December 31, 2023 and 2024 Projections
| Cash and cash equivalents: $10.5 million at December 31, 2023. During 2023, Dar received approximately $4.7 million in nondilutive grant funding and also completed a $7.0 million registered direct offering in September and a $12.0 million royalty-backed financing structure in December, under which Dar received $5 million and may, in its sole discretion, elect to receive up to an additional $7 million in three tranches over time. | |
| During 2023, Dar recognized total revenue of approximately $2.8 million, which included a $1.0 million payment in July 2023 and an additional $1.8 million milestone payment in October 2023 from Dar 's commercial collaborator Organon relating to XACIATO. Dar reported a net loss for 2023 of approximately $30.1 million. | |
| General and administrative (G&A) expenses were approximately $12.1 million for 2023, which was up approximately 8% compared to the prior year. Dar has made fiscal responsibility a top priority, maintaining a lean and focused team and managing overhead costs closely. To that end, Dar expects a reduction in 2024 G&A expenses to approximately $10.0 million (which, however, does not reflect $10 million in capital required to fund G&A expenses since approximately $3.0 million of projected 2024 G&A expenses is estimated accrual based non-cash expenses). | |
| Research and development (R&D) expenses were approximately $21.5 million in 2023, compared to approximately $30.0 million in the prior year, and primarily reflected the costs of the Phase 1 and Phase 2b studies of Sildenafil Cream, the Phase 1 study of DARE-PDM1, and manufacturing activities as well as preparing for and beginning enrollment in the Phase 3 study of Ovaprene. Currently in 2024, Dar 's only active clinical study is the Phase 3 pivotal study of Ovaprene, for which Dar remitted in prior years all but $0.5 million of funds due to the NIH to support the study under the Cooperative Research and Development Agreement (CRADA), and therefore, planned Ovaprene expenses in 2024 will be primarily associated with certain manufacturing activities. Apart from Ovaprene related expenses, currently projected 2024 R&D expenses are primarily carry-over/ close out expenses from the studies completed in 2023. Therefore, until such time as any additional late-stage clinical study is commenced, Dar expects 2024 R&D expenses to be considerably less than the 2023 R&D expenses. |
will host a conference call and live webcast today, March 28, 2024, at 4:30 p.m. Eastern Time to review financial results for the year
ended December 31, 2023 and to provide a company update.
access the conference call via phone, dial (646) 307-1963 (U.S.) or (800) 715-9871 (international). The conference ID number for the
call is 7156675. 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 April 11, 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