Daré Bioscience Regains Compliance with Nasdaq Minimum Bid Price Rule

Rhea-AI Summary

Daré Bioscience (NASDAQ: DARE) has regained compliance with Nasdaq's minimum bid price rule, as announced on July 19, 2024. The company's stock closed at $1.00 or higher for 10 consecutive trading sessions, meeting the Nasdaq Listing Rule 5550(a)(2) requirement. CEO Sabrina Martucci Johnson expressed enthusiasm about this development, stating it strengthens the company's market position and enhances its ability to advance its vision.

Johnson also provided updates on key programs in Daré's portfolio:

• Ongoing enrollment in the pivotal Phase 3 study of Ovaprene®, a potential first-in-category hormone-free monthly intravaginal contraceptive
• Continued activities supporting progression toward a Phase 3 trial of Sildenafil Cream, 3.6% for female sexual arousal disorder, an area with no current FDA-approved treatments

The company remains focused on accelerating the development of innovative treatments for women's health, with an emphasis on first-in-category opportunities.

Positive

• Regained compliance with Nasdaq's minimum bid price rule, avoiding potential delisting
• Ongoing enrollment in pivotal Phase 3 study for Ovaprene®, a potential first-in-category contraceptive
• Progressing towards Phase 3 trial for Sildenafil Cream, 3.6% in female sexual arousal disorder

Negative

• None.

SAN DIEGO, July 19, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, announced that it was notified by the Nasdaq Office of General Counsel that the Company regained compliance with the minimum bid price requirement in Nasdaq Listing Rule 5550(a)(2) as a result of the closing bid price of the Company’s common stock being $1.00 per share or greater for 10 consecutive trading sessions and that the matter is closed.

“We are thrilled to announce that we have regained compliance with the Nasdaq minimum bid price rule,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “This strengthens our position in the market and enhances our ability to drive our vision forward. We look forward to the opportunity to accelerate our development efforts on key programs in our portfolio and to ultimately provide great therapeutic options for women.”

“We continue to enroll participants in our pivotal Phase 3 study of Ovaprene^®, our potentially first-in-category hormone-free monthly intravaginal contraceptive candidate, at sites across the U.S.,” Johnson continued. “We are also continuing activities to support progressing toward a Phase 3 trial of Sildenafil Cream, 3.6% in female sexual arousal disorder, for which there are currently no FDA-approved treatments. We continue to execute on our mission to accelerate development of and bring to market innovative treatments that women want and need by advancing our late-stage candidates – all of which represent a first-in-category opportunity – as we seek to deliver value for all Daré stakeholders.”

About Daré Bioscience
Daré 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.

The first FDA-approved product to emerge from Daré’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. Organon commenced U.S. marketing of XACIATO in the fourth quarter of 2023. Daré’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 XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s mission to deliver differentiated therapies for women, please visit www.darebioscience.com.

Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards.

Daré 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. Daré 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 Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré 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 Daré’s website.

Forward-Looking Statements
Daré 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 Daré’s product candidates, including clinical development plans, targeted indications, the potential for FDA approval of Ovaprene based on a single pivotal clinical study, and the expectation that a product candidate could be a first-in-category product. 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 Daré is developing it. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’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: Daré’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; Daré’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; Daré’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; Daré’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 the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts:

Media and Investors on behalf of Daré Bioscience, Inc:

Camilla White / Simona Kormanikova
Dentons Global Advisors
DareBioscience@dentonsglobaladvisors.com / 1.212.466.6450

Source: Daré Bioscience, Inc.

FAQ

What did Daré Bioscience (DARE) announce on July 19, 2024?

Daré Bioscience announced that it regained compliance with Nasdaq's minimum bid price rule, as its stock closed at $1.00 or higher for 10 consecutive trading sessions.

What is the current status of Daré Bioscience's (DARE) Ovaprene® clinical trial?

Daré Bioscience is currently enrolling participants in the pivotal Phase 3 study of Ovaprene®, their potentially first-in-category hormone-free monthly intravaginal contraceptive candidate.

What is Daré Bioscience (DARE) developing for female sexual arousal disorder?

Daré Bioscience is developing Sildenafil Cream, 3.6% for female sexual arousal disorder and is progressing towards a Phase 3 trial for this product.

How does regaining Nasdaq compliance benefit Daré Bioscience (DARE)?

Regaining Nasdaq compliance strengthens Daré Bioscience's position in the market, enhances its ability to drive its vision forward, and allows the company to focus on accelerating development efforts for key programs in its portfolio.