Press Release
Daré Bioscience Reports Full Year 2023 Financial Results and Provides Company Update
2023 Highlights and Anticipated 2024 Milestones
- XACIATO™ (clindamycin phosphate) vaginal gel 2% is available by prescription in
the United States to treat bacterial vaginosis under license agreement with commercial collaborator Organon - Ovaprene® hormone-free monthly intravaginal contraceptive candidate pivotal Phase 3 contraceptive efficacy study recruiting across
the United States - Sildenafil Cream, 3.6% topical formulation of sildenafil being developed to treat female sexual arousal disorder successful completion of end-of-Phase 2 meeting with FDA; forthcoming additional FDA feedback; Phase 3 design, development, and collaboration strategy updates
“We are pleased with the incredible progress we made in 2023 with our late-stage candidates and on-market product, including the
In 2023, Daré announced the first shipment of XACIATO™ in connection with its launch in
XACIATO™
XACIATO (clindamycin phosphate) vaginal gel 2% is indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. Please see below for important safety and other information.
Bacterial vaginosis is the most common vaginal condition in women of reproductive age in
On
As an on-market product, XACIATO represents a non-dilutive source of revenue for Daré. Daré is eligible to receive double digit royalties based on net sales and up to
Ovaprene® Phase 3 Study Start
Ovaprene is a novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with
Working with study collaborators at the
Recruitment is currently underway at 17 sites across
Positive Data for Sildenafil Cream, 3.6%
Sildenafil Cream is a proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical on-demand administration to treat female sexual arousal disorder.
Daré has completed all study analyses of data from the exploratory Phase 2b RESPOND clinical study and held an end-of-Phase 2 meeting with the FDA in
Daré’s planned Phase 3 study of Sildenafil Cream, 3.6% would be the first ever Phase 3 pivotal study of a therapeutic candidate for the treatment of arousal disorder in women. Daré intends to provide updates on the FDA feedback, Phase 3 study design and plans, as well as any relevant updates on its collaboration strategy as available in 2024.
DARE-PDM1
A proprietary, investigational formulation of diclofenac for intravaginal administration to treat menstrual cramping pain (dysmenorrhea).
In
DARE-VVA1
A proprietary, investigational formulation of tamoxifen for intravaginal administration to treat sexual pain (dyspareunia) in women without the use of hormones.
In
With the IND clearance from the FDA, Daré can begin planning for an anticipated Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1. Such planning and preparatory activities are underway.
Financial Highlights for the Year Ended
- Cash and cash equivalents:
$10.5 million atDecember 31, 2023 . During 2023, Daré received approximately$4.7 million in nondilutive grant funding and also completed a$7.0 million registered direct offering in September and a$12.0 million royalty-backed financing structure in December, under which Daré received$5 million and may, in its sole discretion, elect to receive up to an additional$7 million in three tranches over time. - During 2023, Daré recognized total revenue of approximately
$2.8 million , which included a$1.0 million payment inJuly 2023 and an additional$1.8 million milestone payment inOctober 2023 from Daré's commercial collaborator Organon relating to XACIATO. Daré reported a net loss for 2023 of approximately$30.1 million . - General and administrative (G&A) expenses were approximately
$12.1 million for 2023, which was up approximately 8% compared to the prior year. Daré has made fiscal responsibility a top priority, maintaining a lean and focused team and managing overhead costs closely. To that end, Daré expects a reduction in 2024 G&A expenses to approximately$10.0 million (which, however, does not reflect$10 million in capital required to fund G&A expenses since approximately$3.0 million of projected 2024 G&A expenses is estimated accrual based non-cash expenses). - Research and development (R&D) expenses were approximately
$21.5 million in 2023, compared to approximately$30.0 million in the prior year, and primarily reflected the costs of the Phase 1 and Phase 2b studies of Sildenafil Cream, the Phase 1 study of DARE-PDM1, and manufacturing activities as well as preparing for and beginning enrollment in the Phase 3 study of Ovaprene. Currently in 2024, Daré's only active clinical study is the Phase 3 pivotal study of Ovaprene, for which Daré remitted in prior years all but$0.5 million of funds due to theNIH to support the study under theCooperative Research and Development Agreement (CRADA), and therefore, planned Ovaprene expenses in 2024 will be primarily associated with certain manufacturing activities. Apart from Ovaprene related expenses, currently projected 2024 R&D expenses are primarily carry-over/ close out expenses from the studies completed in 2023. Therefore, until such time as any additional late-stage clinical study is commenced, Daré expects 2024 R&D expenses to be considerably less than the 2023 R&D expenses.
Conference Call
Daré will host a conference call and live webcast today,
To access the conference call via phone, dial (646) 307-1963 (
About XACIATOTM (clindamycin phosphate) vaginal gel 2%
XACIATO is indicated for the treatment of bacterial vaginosis in females 12 years and older. A single-dose user-filled disposable applicator delivers 5g of vaginal gel containing 100mg of clindamycin.
Selected Safety Information
XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.
Polyurethane condoms are not recommended during treatment with XACIATO or for 7 days following treatment. During this time period, polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Latex or polyisoprene condoms should be used.
XACIATO may result in the overgrowth of Candida spp. in the vagina resulting in vulvovaginal candidiasis, which may require antifungal treatment.
The most common adverse reactions reported in >2% of patients and at a higher rate in the XACIATO group than in the placebo group were vulvovaginal candidiasis and vulvovaginal discomfort.
XACIATO has not been studied in pregnant women. However, based on the low systemic absorption of XACIATO following the intravaginal route of administration in nonpregnant women, maternal use is not likely to result in significant fetal exposure to the drug.
There are no data on the effect of clindamycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.
Please see the Prescribing Information, Patient Information, and Instructions for Use.
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
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
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),
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, trial design, timelines and milestones, targeted indications, and anticipated regulatory approval pathways, 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, the potential market size and opportunity for a product candidate, if approved, and financial projections for 2024. 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
Contacts:
Media and Investors on behalf of Daré
DareBioscience@dentonsglobaladvisors.com / 1.212.466.6450
Source: Daré
| Consolidated Statement of Operations and Comprehensive Loss | ||||||||
| Years Ended |
||||||||
| 2023 | 2022 | |||||||
| Revenue | ||||||||
| License fee revenue | $ | 1,000,000 | $ | 10,000,000 | ||||
| Milestone revenue | 1,800,000 | - | ||||||
| Royalty revenue | 7,885 | - | ||||||
| Total revenue | 2,807,885 | 10,000,000 | ||||||
| Operating expenses | ||||||||
| General and administrative | 12,109,691 | 11,243,271 | ||||||
| Research and development | 21,538,074 | 30,042,217 | ||||||
| License fee expense | 100,000 | 100,000 | ||||||
| Total operating expenses | 33,747,765 | 41,385,488 | ||||||
| Loss from operations | (30,939,880 | ) | (31,385,488 | ) | ||||
| Other income | 778,489 | 437,750 | ||||||
| Net loss | $ | (30,161,391 | ) | $ | (30,947,738 | ) | ||
| Net loss to common shareholders | (30,161,391 | ) | (30,947,738 | ) | ||||
| Foreign currency translation adjustments | (9,585 | ) | (196,338 | ) | ||||
| Comprehensive loss | $ | (30,170,976 | ) | $ | (31,144,076 | ) | ||
| Loss per common share - basic and diluted | $ | (0.35 | ) | $ | (0.37 | ) | ||
| Weighted average number of common shares outstanding: | ||||||||
| Basic and diluted | 87,303,701 | 84,571,805 | ||||||
| Consolidated Balance Sheets Data | ||||||||
| 2023 | 2022 | |||||||
| Cash and cash equivalents | $ | 10,476,056 | $ | 34,669,605 | ||||
| Working capital (deficit) | $ | (2,936,897 | ) | $ | 11,414,826 | |||
| Total assets | $ | 21,282,215 | $ | 43,826,383 | ||||
| Total liabilities | $ | 26,329,855 | $ | 32,714,273 | ||||
| Total stockholders' equity (deficit) | $ | (5,047,640 | ) | $ | 11,112,110 | |||
Source: Daré Bioscience, Inc.