Press Release
Daré Bioscience Reports Second Quarter 2024 Financial Results and Provides Company Update
Conference Call and Webcast Today at
Development Program Highlights and Anticipated 2024 Milestones
- 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 continued operational progress toward a planned Phase 3 study; additional FDA feedback forthcoming; Phase 3 design, development, and collaboration strategy updates
“In addition to the continued commercialization by our collaborator Organon of XACIATO™ (clindamycin phosphate) vaginal gel 2%, the first FDA-approved product to emerge from our portfolio and a treatment for bacterial vaginosis in females aged 12 and older* that is available by prescription nationwide, we continue to advance our first-in-category Phase 3 development candidates. Enrollment in our Phase 3 study of Ovaprene, our potentially first-in-category hormone-free monthly intravaginal contraceptive candidate, is ongoing at sites across the
*Please see below for important safety and other information.
Ovaprene® Phase 3 Study
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 20 sites across
Sildenafil Cream, 3.6% Progress toward Phase 3 Study
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 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 initial 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 Phase 3 program, as well as relevant updates on the initial Phase 3 study timing and Daré’s collaboration strategy as they become available.
Financial Highlights for the Quarter ended
- Cash and cash equivalents:
$16.4 million atJune 30, 2024 . InApril 2024 , Daré received$22 million in gross proceeds in a non-dilutive royalty monetization transaction withXOMA (US) LLC and a$1 million payment as the latest installment under an up to$49 million grant agreement with a foundation in support of nonclinical development of the investigational contraceptive, DARE-LARC1. To date, Daré has received approximately$29.3 million under the DARE-LARC1 grant agreement. - General and administrative expenses:
$2.4 million in 2Q-2024 as compared to$2.9 million in 2Q-2023, with the current quarter’s decrease primarily attributable to reduced headcount and reduced professional services expense. - Research and development (R&D) expenses:
$4.9 million in 2Q-2024 as compared to$6.0 million in 2Q-2023, a 19% decrease compared to Q2-2023, with the current quarter’s decrease primarily attributable to decreases in costs related to development activities for Sildenafil Cream as a result of the Phase 2b RESPOND clinical study completion inJune 2023 and decreases in costs related to development activities for our other programs, offset by increases in costs related to our ongoing pivotal Phase 3 clinical trial of Ovaprene.
Conference Call
Daré will host a conference call and live webcast today,
To access the conference call via phone, dial (646) 307-1952 (
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, costs and milestones, targeted indications, and anticipated regulatory approval pathways, the potential for FDA approval of Ovaprene 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. 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
Contacts:
Media and Investors on behalf of Daré
DareBioscience@dentonsglobaladvisors.com / 1.212.466.6450
Source: Daré
| Daré |
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| Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) | ||||||||
| (Unaudited) | ||||||||
| Three months ended |
||||||||
| 2024 | 2023 | |||||||
| Revenue | ||||||||
| Royalty revenue | $ | 22,438 | $ | - | ||||
| Total revenue | 22,438 | |||||||
| Operating expenses | ||||||||
| General and administrative | 2,448,130 | 2,920,672 | ||||||
| Research and development | 4,908,774 | 6,043,684 | ||||||
| License fee expense | 25,000 | 25,000 | ||||||
| Total operating expenses | 7,381,904 | 8,989,356 | ||||||
| Loss from operations | (7,359,466 | ) | (8,989,356 | ) | ||||
| Other income (expense) | ||||||||
| Sale of royalty and milestone rights, net | 20,379,376 | - | ||||||
| Other income (expense), net | (109,254 | ) | 227,124 | |||||
| Net income (loss) | $ | 12,910,656 | $ | (8,762,232 | ) | |||
| Foreign currency translation adjustments | $ | 14,563 | $ | (31,151 | ) | |||
| Comprehensive income (loss) | $ | 12,925,219 | $ | (8,793,383 | ) | |||
| Income (loss) per common share: | ||||||||
| Basic | $ | 1.53 | $ | (1.22 | ) | |||
| Diluted | $ | 1.52 | $ | (1.22 | ) | |||
| Weighted average number of shares outstanding: | ||||||||
| Basic | 8,411,242 | 7,200,260 | ||||||
| Diluted | 8,476,231 | 7,200,260 | ||||||
| Daré |
||||||||
| Condensed Consolidated Balance Sheets Data | ||||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 16,414,992 | $ | 10,476,056 | ||||
| Working capital (deficit) | $ | 6,239,522 | $ | (2,936,897 | ) | |||
| Total assets | $ | 23,606,239 | $ | 21,282,215 | ||||
| Total stockholders' equity (deficit) | $ | 2,671,506 | $ | (5,047,640 | ) | |||
Source: Daré Bioscience, Inc.