Dar Bioscience Reports Third Quarter 2023 Financial Results and Provides Company Update Conference Call and Webcast Today at 4:30 p.m. ET What to Expect for the Remainder of 2023 XACIATO : receipt of $1.8 million trigger

Bioscience Reports Third Quarter 2023 Financial Results and Provides Company Update

Call and Webcast Today at 4:30 p.m. ET

to Expect for the Remainder of 2023

DIEGO November 9, 2023 (GLOBE NEWSWIRE) - Dar Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation,

today reported financial results for the quarter ended September 30, 2023 and provided a company update.

are pleased with the incredible progress we have made since the beginning of the third quarter, including the U.S. launch of XACIATO

and moving several of our product candidates forward, further positioning the company for long-term success," said Sabrina Martucci

Johnson, President and CEO of Dar Bioscience. "The fourth quarter is also proving to be a busy one for Dar , and

we remain on track to have multiple meaningful milestones by the end of 2023 as we execute on our mission to accelerate development of

and bring to market innovative treatments that women want and need."

U.S. Launch Underway

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.

Toward Ovaprene Phase 3 Study Start

additional progress working 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 Bayer, Dar remains on target to commence patient enrollment

in the Ovaprene pivotal Phase 3 clinical study in the fourth quarter of this year. 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 is an investigational monthly, intravaginal, hormone-free contraceptive with

the 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.

Positive Data for Sildenafil Cream, 3.6%

has completed all study analyses of data from the exploratory Phase 2b RESPOND clinical study in preparation for the upcoming end-of-Phase

2 FDA meeting in the fourth quarter of this year. On November 2, 2023, the company reported additional positive data from the Phase 2b

RESPOND study, which indicate that Dar can use its Phase 2b study approach in Phase 3. Specifically, Dar plans to propose

a Phase 3 clinical study with the same co-primary endpoint structure used in the Phase 2b RESPOND study, which assesses arousal sensation

and evaluates concerns related to difficulties with sexual arousal, and will propose evaluating Sildenafil Cream, 3.6% in a broader patient

population of women that includes women with female sexual arousal disorder (FSAD) as well as those with arousal plus desire disorder

(female sexual interest/arousal disorder, or FSIAD). Dar 's 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.

(clindamycin phosphate) vaginal gel 2%

lincosamide antibacterial 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. The condition results from an overgrowth

of 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

novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with

pivotal Phase 3 clinical study will be conducted under a Cooperative Research and Development Agreement with the U.S. Department of Health

and Human Services, as represented by NICHD, part of the NIH.

proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra , for topical on-demand

administration to treat female sexual arousal disorder and/or female sexual interest/arousal disorder.

unique, investigational intravaginal ring designed to deliver bio-identical estradiol and progesterone continuously over a 28-day period

for the treatment of moderate to severe vasomotor symptoms, as part of menopausal hormone therapy.

proprietary, investigational formulation of tamoxifen for intravaginal administration to treat vulvovaginal atrophy in women without

the use of hormones.

Highlights for the Quarter ended September 30, 2023

will host a conference call and live webcast today, November 9, 2023, at 4:30 p.m. Eastern Time to review financial results for the quarter

ended September 30, 2023 and to provide a company update.

access the conference call via phone, dial (888) 596-4144 (U.S.) or (646) 968-2525 (international). The conference ID number for the

call is 2750536. 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

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, XACIATO (clindamycin phosphate) vaginal gel 2% is 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. 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 to treat female sexual arousal disorder (FSAD) and/or female sexual interest/arousal disorder (FSIAD)

utilizing the active ingredient in Viagra ; 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