Dar Bioscience Reports First Quarter 2023 Financial Results and Provides a Company Update Conference Call and Webcast Today at 4:30 p.m. ET 2023 Anticipated Milestones: Sildenafil Cream, 3.6% for Female Sexual Arousal Di

Bioscience Reports First Quarter 2023 Financial Results and Provides a Company Update Conference Call and Webcast Today at 4:30

Anticipated Milestones:

DIEGO May 11, 2023 (GLOBE NEWSWIRE) - Dar Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation,

today reported financial results for the quarter ended March 31, 2023 and provided a company update.

focused efforts to deliver differentiated innovation in women's health have resulted in 12 development programs across nine distinct

indications, with at least five milestone events anticipated in 2023, three products in or nearing Phase 3 clinical development, two

potentially transformational collaborations with leaders in women's health product commercialization, Bayer and Organon, and one

FDA approved product, XACIATO," said Sabrina Martucci Johnson, President and CEO of Dar Bioscience.

am particularly excited about the second quarter of 2023 given our expectations for two meaningful milestones for Dar and for

women. First, we plan to announce topline data from our exploratory Phase 2b clinical study of Sildenafil Cream, 3.6%, our candidate

for female sexual arousal disorder, or FSAD, an indication for which there are no FDA-approved treatments. FSAD is analogous to erectile

dysfunction in men, and it is our belief that this market, in terms of the number of women suffering from and distressed by their lack

of physical genital arousal response, could be as large, or even larger, than the ED market for men. Second, we anticipate the commercial

launch in the U.S. of XACIATOTM for the treatment of bacterial vaginosis by our commercial collaborator, Organon," said

2023 In Review and Q2-Q4 2023 Anticipated Developments

(clindamycin phosphate) vaginal gel, 2%:

clear, colorless, viscous gel to be administered once intravaginally as a single dose for the treatment of bacterial vaginosis in female

patients 12 years of age and older. Please click here for full prescribing Information.

vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 23 million women in the U.S.1

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. In addition to being the most common type of vaginal infection in women of reproductive age and having

bothersome symptoms, bacterial vaginosis has been associated with certain increased health risks, including pre-term labor and infertility.1,

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

planned 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 the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD),

part of the National Institutes of Health (NIH).

proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra , for topical administration to treat

female sexual arousal disorder.

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

period for the treatment of menopausal symptoms, including moderate to severe vasomotor symptoms, as part of a menopause hormone therapy

proprietary, investigational formulation of tamoxifen for intravaginal administration to treat vulvar and vaginal atrophy in women without

the use of hormones.

Highlights for the Quarter ended March 31, 2023

https://www.cdc.gov/std/bv/stats.htm and https://www.census.gov/data/datasets/2017/demo/popproj/2017-popproj.html

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

31, 2023 and to provide a company update.

access the conference call via phone, dial (800) 715-9871 (U.S.) or (646) 307-1963 (international). The conference ID number for the

call is 7046999. 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 25,

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. XACIATO

is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. 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 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.

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 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,"

"contemplate," "project," "target," "objective," or the negative version of these words

and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to plans

and expectations with respect to Dar 's product candidates, including anticipated timing for commencement and conduct of

clinical trials and announcement of topline results, the potential for FDA approval of a product candidate based on a single pivotal

clinical study, the expectation that a product candidate could be a first-in-category product, and the potential market size and opportunity

for a product candidate, if approved, and expectations regarding the commercial launch of XACIATO in the U.S., including the strategy,

efforts and capabilities of Dar 's commercial collaborator and the timing of the first commercial sale of XACIATO. Forward-looking

statements involve known and unknown risks, uncertainties and other factors that may cause Dar 's actual results, performance

or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking

statements in this press release, including, without limitation, risk and uncertainties related to: Dar 's ability to raise

additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern;

Dar 's ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to

do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Dar 's

ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints,

to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates;

Dar 's dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial

product; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of

success in subsequent clinical and/or nonclinical studies of that candidate; the risk that development of a product candidate requires

more clinical or nonclinical studies than Dar anticipates; the loss of, or inability to attract, key personnel; the effects of

the COVID-19 pandemic, macroeconomic conditions and geopolitical events on Dar 's operations, financial results and condition,

and ability to achieve current plans and objectives, including the potential impact of the pandemic on Dar 's ability to

timely enroll, conduct and report results of its clinical trials and on the ability of third parties on which Dar relies to assist

in the conduct of its business to fulfill their contractual obligations to Dar ; the risk that developments by competitors make

Dar 's product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships

with development and/or commercial collaborators; failure of Dar 's product or product candidates, if approved, to gain

market acceptance or obtain adequate coverage or reimbursement from third-party payers; Dar 's ability to retain its licensed