Dar Bioscience Reports Second Quarter 2022 Financial Results and Provides a Company Update

Bioscience Reports Second Quarter 2022 Financial Results and

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

DIEGO, August 9, 2022 (GLOBE NEWSWIRE) - Dar Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation,

today reported financial results for the quarter ended June 30, 2022 and provided a company update.

the second quarter, we closed our global license agreement with Organon to commercialize XACIATO, an FDA-approved treatment for females

12 years of age and older with bacterial vaginosis, and recognized our first revenue of $10 million under the agreement. The teams at

Dar and Organon have been working diligently and collaboratively toward the targeted commercial launch of XACIATO in the U.S.

during the fourth quarter of 2022. Both companies remain highly committed to introducing a new therapeutic option for treating this condition,

which is estimated to affect approximately 21 million women,1" said Sabrina Martucci Johnson, President and CEO of Dar

vaginosis is the most common cause of vaginitis worldwide.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.2

during the second quarter, we continued to advance our other portfolio candidates. Two Phase 1/2 studies are ongoing: DARE-VVA1, our

non-hormonal treatment for vulvar and vaginal atrophy for women with or at risk for hormone receptor positive breast cancer, using a

novel vaginal administration of tamoxifen; and DARE-HRT1, an intravaginal ring to provide bio-identical hormone therapy for the treatment

of menopausal systems with one IVR delivering both progesterone and estradiol together over 28 days. Both studies are being conducted

in Australia, allowing us to take advantage of the Australian research and development cash rebate program. Both the DARE-VVA1 and the

DARE-HRT1 studies are on track to report topline data in the fourth quarter of 2022. We are advancing the regulatory activities needed

to initiate the pivotal Phase 3 study of Ovaprene planned to commence later this year. Finally, we continue to enroll and treat

patients in our ongoing Phase 2b RESPOND clinical study for female sexual arousal disorder, with an interim analysis for study sizing

planned for this year. "

Key Portfolio Objectives

Portfolio Accomplishments and FY-2022 Expectations

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.

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

proprietary, investigational formulation of tamoxifen for vaginal administration to treat vulvar and vaginal atrophy in women with or

at risk for hormone-receptor positive breast cancer.

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

for the treatment of menopausal symptoms, including vasomotor symptoms, as part of hormone therapy following menopause.

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

to treat female sexual arousal disorder.

Highlights for the Quarter ended June 30, 2022

Events from July 1, 2022 through August 8, 2022

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

2022 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 3817141. 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. To access the replay, please call (800) 770-2030 (U.S.) or (609) 800-9909 (international).

The conference ID number for the replay is 3817141. The call and webcast replay will be available until August 23, 2022.

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, fertility, and vaginal and sexual

first FDA-approved product, XACIATOTM (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 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 hormone therapy following menopause. 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 expectations

regarding the timing of when XACIATO will be commercially available in the U.S. and plans and expectations with respect to Dar 's

product candidates, including anticipated timing for commencement and conduct of clinical trials and clinical trial data readouts for

Dar 's product candidates. 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 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; 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; 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 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 developments by competitors make Dar 's product or

product candidates less competitive or obsolete; failure to timely establish or maintain third-party partnerships or collaborations to

develop and/or commercialize Dar 's product and Dar 's product candidates, if approved; failure of Dar 's