Dar Bioscience Announces Phase 3 Plans for Sildenafil Cream, 3.6%, in the Treatment of Female Sexual Arousal Disorder (FSAD) FSAD is clinically analogous to erectile dysfunction in men. To date, there are no FDA-approved

Bioscience Announces Phase 3 Plans for Sildenafil Cream, 3.6%, in the Treatment of Female Sexual Arousal Disorder (FSAD)

is clinically analogous to erectile dysfunction in men.

date, there are no FDA-approved pharmacological treatments for FSAD; Dar 's Sildenafil Cream has the potential to receive

the first FDA approval for FSAD.

research estimates approximately 10 million women in the U.S. are distressed from experiencing symptoms associated with FSAD and are

actively seeking solutions to improve their condition.

DIEGO, December 16, 2024 (GLOBE NEWSWIRE) - Dare Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and

wellbeing of women, and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery

company, today announced plans for a Phase 3 study of Sildenafil Cream, 3.6%, an investigational topical cream formulation of sildenafil

being developed as an on-demand treatment for female sexual arousal disorder (FSAD), reflecting U.S. Food and Drug Administration (FDA)

feedback for safety and efficacy evaluations to support the indication of treatment of FSAD in premenopausal women.

have appreciated the FDA's collaboration on the Phase 3 design for this novel therapeutic indication for women," said Sabrina

Martucci Johnson, President and CEO of Dar Bioscience. "While increased attention has been focused on female sexual dysfunctions

over the past several years, no pharmacologic options have yet been FDA approved for FSAD, a condition which significantly compromises

a woman's ability to have a pleasurable sexual experience. We are excited about the potential for Dar 's Sildenafil

Cream formulation to address this critical unmet need in women's sexual health, and that there is a clear path forward on how to

evaluate the safety and efficacy of this novel formulation of the same active in Viagra so that women may have access to a safe,

effective and on demand' solution to difficulties with sexual arousal allowing for a more intense and enjoyable sexual experience."

an immediate next step, Dar will submit the protocol and statistical analysis plan for an adequate and well-controlled Phase

3 clinical study, reflecting the FDA's recommendations, to the FDA in the first quarter of 2025, and is targeting mid-2025 for

commencement of the Phase 3 study.

second confirmatory Phase 3 study will be required to support the New Drug Application (NDA) submission.

Sildenafil Cream's potential to be the first FDA-approved product for FSAD, Dar is poised to create a new market category

within the female sexual dysfunction space.

FSAD and Sildenafil Cream, 3.6%

as described in the DSM-IV, is a condition characterized primarily by a persistent or recurrent inability to attain or maintain sufficient

genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal

difficulty. FSAD is clinically analogous to erectile dysfunction (ED) in men. As with ED in men, FSAD is associated with insufficient

blood flow to the genitalia. To date, there are no FDA-approved pharmacological treatments for FSAD.

a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand

name Viagra for the treatment of ED in men. Sildenafil Cream, 3.6% (Sildenafil Cream) is an investigational, proprietary cream formulation

of sildenafil designed for topical administration to the vulvar-vaginal tissue on demand to increase genital blood flow and provide improvements

in the female genital arousal response, while avoiding systemic side effects observed with oral formulations of sildenafil.

research suggests that 16% of women in the U.S. ages 21 to 60, or approximately 10 million women, are distressed from experiencing symptoms

associated with FSAD, including lack of or low sexual arousal, and are actively seeking solutions to improve their condition. In comparison,

the prevalence of complete ED in men is estimated to be about 5% of men at age 40, increasing to about 15% at age 70.

Sildenafil Cream, 3.6% Exploratory Phase 2b RESPOND Study

exploratory Phase 2b RESPOND study was specifically designed to identify the patient population that experienced the most meaningful

improvement from Sildenafil Cream and the questions to ask them, or the patient-reported outcome (PRO) measures, that best reflect that

improvement, to inform Phase 3 design for this potential first-in-category treatment for FSAD. As previously announced, safety and efficacy

data from the Phase 2b RESPOND study have been published in The Journal of Sexual Medicine and Obstetrics & Gynecology,

with the previously completed Phase 2b RESPOND study, the planned Phase 3 study will include a 12-week double-blind treatment period

evaluating Sildenafil Cream compared to placebo cream.

to previously approved treatments for ED in men, the Phase 3 study will have co-primary efficacy endpoints. Clinical programs for approved

ED products have evaluated three co-primary endpoints specific to sexual arousal. For FSAD, the FDA has recommended a clinical program

consistent with the Phase 2b RESPOND study, where only two co-primary endpoints were included - one assessing arousal sensations

and one assessing associated distress, where distress is included as a co-primary endpoint to support the treatment effect of Sildenafil

Cream. The Sildenafil Cream Phase 3 study will include the same co-primary endpoints for arousal sensations and associated distress used

in the Phase 2b RESPOND study.

addition, secondary endpoints to assess improvement in orgasm, desire, and distress and interpersonal difficulties will be included,

as they were in the Phase 2b RESPOND study. Claims of treatment benefit of the symptoms (but not the indications of Hypoactive Sexual

Desire Disorder or Female Orgasmic Dysfunction) can be pursued via clear endpoint definition and formal statistical testing with adjustment

for multiplicity, including a plan to control the type 1 error rate, which Dar plans to include in its protocol and statistical

analysis plan for the Phase 3 study.

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, sexual health, pelvic pain, fertility,

infectious diseases, and menopause.

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. Visit www.xaciato.com for information about XACIATO.

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 Dar 's

full portfolio of women's health product candidates and 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

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 X (formerly 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 the

therapeutic potential and safety profile of Sildenafil Cream, Dar 's plans for continued clinical development of Sildenafil

Cream, including Phase 3 trial design and statistical analysis plan and the timing of commencing the first Phase 3 study, Dar 's

expectations that the Phase 3 trial design and statistical analysis plan will reflect the FDA's recommendations and have the characteristics

of an adequate and well-controlled clinical study, the anticipated pathway for FDA approval of Sildenafil Cream for the treatment of

FSAD in premenopausal women, the potential for Sildenafil Cream to be the first FDA-approved treatment for FSAD, and the potential market

opportunity for Sildenafil Cream. As used in this press release, the description of a product candidate as "first-in-category"

is a forward-looking statement relating to the potential of the candidate to represent a new category of product if it were to receive

marketing approval for the indication for which Dar is developing it. 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, risks and uncertainties related to: potential insufficiency of Dar 's capital resources to advance the

development of its product candidates, including Sildenafil Cream for the treatment of FSAD, on communicated timelines, or at all; failure

or delay in starting, conducting and completing clinical trials of a product candidate, including the first Phase 3 clinical study of

Sildenafil Cream, including due to lack of sufficient capital resources; 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 inherent uncertainty