Conference Call and Webcast Today at 4:30 p.m. ET
2023 Anticipated Milestones:
SAN DIEGO, May 11, 2023 (GLOBE NEWSWIRE) — Daré 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.
“Our 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 Daré Bioscience.
“I am particularly excited about the second quarter of 2023 given our expectations for two meaningful milestones for Daré 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 Ms. Johnson.
Q1 2023 In Review and Q2-Q4 2023 Anticipated Developments
Period | Portfolio Asset | Development/Outcome | |
Q1 | DARE-HRT1 | Announced positive topline pharmacokinetic (PK) data from Phase 1/2 clinical study | |
DARE-PDM1 | Commenced Phase 1 clinical study in Australia | ||
Q2 (expected) | Sildenafil Cream, 3.6% | Announcement of topline results of Phase 2b RESPOND clinical study | |
XACIATOTM | Commercial launch of XACIATO; first commercial sale milestone of $2.5 million | ||
Mid-2023 (expected) | Ovaprene® | Initiation of patient enrollment in pivotal study with NICHD | |
2023 (expected) | DARE-HRT1 | IND preparation and other activities to allow initiation of Phase 3 clinical study | |
DARE-PDM1 | Announcement of topline results of Phase 1 clinical study | ||
DARE-VVA1 | IND preparation and other activities to allow initiation of Phase 2 clinical study | ||
Portfolio Summary
XACIATOTM (clindamycin phosphate) vaginal gel, 2%:
A 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.
Bacterial 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, 2
Ovaprene®:
A novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare.
The 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).
Sildenafil Cream, 3.6%:
A proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical administration to treat female sexual arousal disorder.
DARE-HRT1:
A 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 regimen.
DARE-VVA1:
A proprietary, investigational formulation of tamoxifen for intravaginal administration to treat vulvar and vaginal atrophy in women without the use of hormones.
Financial Highlights for the Quarter ended March 31, 2023
1https://www.cdc.gov/std/bv/stats.htm and https://www.census.gov/data/datasets/2017/demo/popproj/2017-popproj.html
2https://www.mayoclinic.org/diseases-conditions/bacterial-vaginosis/symptoms-causes/syc-20352279
Conference Call
Daré 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.
To 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, 2023.
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.
Daré’s 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. 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 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, 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 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 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 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 Daré’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 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, risk 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 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 the COVID-19 pandemic, macroeconomic conditions and geopolitical events on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Daré’s ability to timely enroll, conduct and report results of its clinical trials and on the ability of third parties on which Daré relies to assist in the conduct of its business to fulfill their contractual obligations to Daré; 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; cyber attacks, security breaches 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:
Investors on behalf of Daré Bioscience, Inc.:
Lee Roth
Burns McClellan
lroth@burnsmc.com
212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:
Jake Robison
Evoke Canale
jake.robison@evokegroup.com
619.849.5383
Source: Daré Bioscience, Inc.
Daré Bioscience, Inc. and Subsidiaries | |||||||
Consolidated Statements of Operations and Comprehensive Loss | |||||||
(Unaudited) | |||||||
Three Months Ended March 31, | |||||||
2023 | 2022 | ||||||
Operating expenses | |||||||
General and administrative | $ | 3,337,426 | $ | 2,569,987 | |||
Research and development | 5,020,223 | 5,805,462 | |||||
License fee expense | 25,000 | 25,000 | |||||
Total operating expenses | 8,382,649 | 8,400,449 | |||||
Loss from operations | (8,382,649 | ) | (8,400,449 | ) | |||
Other income | 340,148 | 1,779 | |||||
Net loss | $ | (8,042,501 | ) | $ | (8,398,670 | ) | |
Foreign currency translation adjustments | (22,005 | ) | (9,150 | ) | |||
Comprehensive loss | $ | (8,064,506 | ) | $ | (8,407,820 | ) | |
Loss per common share – basic and diluted | $ | (0.09 | ) | $ | (0.10 | ) | |
Weighted average number of shares outstanding: | |||||||
Basic and diluted | 85,517,540 | 83,944,119 | |||||
Daré Bioscience, Inc. and Subsidiaries | |||||||
Condensed Consolidated Balance Sheets Data | |||||||
March 31, 2023 |
December 31, 2022 |
||||||
(unaudited) | |||||||
Cash and cash equivalents | $ | 19,829,404 | $ | 34,669,605 | |||
Working capital | $ | 5,174,001 | $ | 11,414,826 | |||
Total assets | $ | 30,366,676 | $ | 43,826,383 | |||
Total stockholders’ equity | $ | 4,971,600 | $ | 11,112,110 | |||
Lehi, Utah--(Newsfile Corp. - December 23, 2024) - As Saprea reflects on the accomplishments of…
Company Unveils the Biggest Topics of Global Optimism: Entertainment, AI and Healthcare. SEOUL, South Korea,…
NEWTOWN, Pa., Dec. 22, 2024 /PRNewswire/ -- The law firm of Edelson Lechtzin LLP is…
Miami, Florida--(Newsfile Corp. - December 21, 2024) - Amid the vibrant backdrop of Art Basel…
Daily Fit Notes, founded by Justin Brey in New York, launches a text-based subscription fitness…
MT. STERLING, Ohio, Dec. 20, 2024 /PRNewswire/ -- WillowWood, a global leader in prosthetic solutions,…