Daré Bioscience Reports Second Quarter 2023 Financial Results and Provides a Company Update
Conference Call and Webcast Today at
Second Half 2023 Anticipated Milestones (target indication(s)):
- XACIATO™ First Commercial Sale
- Ovaprene® (hormone-free monthly contraception) – Pivotal Phase 3 Contraceptive Efficacy Study – Patient Enrollment to Begin 4Q2023
- Sildenafil Cream, 3.6% (female sexual arousal disorder and female sexual interest/arousal disorder) - preparations for end-of-Phase 2 meeting with FDA
- DARE-PDM1 (primary dysmenorrhea) – Phase 1 Clinical Study Topline Data
- Menopause programs: IND related activities for DARE-HRT1 (vasomotor symptoms of menopause) and DARE-VVA1 (vulvovaginal atrophy, a common condition in postmenopausal women, including those whose menopause resulted from receiving certain breast cancer treatments); Phase 3 and Phase 2 clinical study initiation plans, respectively
“We are particularly proud of the milestone we reached in June – the announcement of the topline data from our exploratory Phase 2b RESPOND study evaluating topical Sildenafil Cream, 3.6% as a treatment for female sexual arousal disorder. This study was the first at-home, Phase 2 clinical study by a pharmaceutical drug development company to address a distressing condition for women that is analogous to erectile dysfunction for men utilizing a novel topical cream formulation of sildenafil, the active ingredient in Viagra®,” said
“We also remain very enthusiastic about rest of 2023 given two highly anticipated milestones,” said
1H-2023 In Review and 2H-2023 Anticipated Developments
||DARE-HRT1||Announced positive topline pharmacokinetic (PK) data from Phase 1/2 clinical study|
|DARE-PDM1||Commenced Phase 1 clinical study|
|2Q-2023||Sildenafil Cream, 3.6%||Announced positive topline results of exploratory Phase 2b RESPOND clinical study|
||XACIATO™||First commercial sale|
|Ovaprene®||Initiation of enrollment in pivotal contraceptive study conducted with NICHD|
|Sildenafil Cream, 3.6%||Preparation for end-of-Phase 2 meeting with FDA|
|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|
|DARE-HRT1||IND preparation and other activities to allow initiation of Phase 3 clinical study|
Daré Portfolio Summary
- One FDA approved product, XACIATO™
- 13 development programs across 9 distinct indications
- 3 products in, or nearing, Phase 3 clinical development
- Key XACIATO, Sildenafil Cream, and Ovaprene milestones anticipated during 2H-2023
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. Please click here for full prescribing information.
$10.0 millioncash payment received under commercial license agreement with Organon
$1.0 millioncash received, and $1.8 millionmilestone anticipated upon 1st commercial sale
Bacterial vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 23 million women in the
U.S.2 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. 2, 3
A novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with
- 4Q-2022: Investigator meeting held (with NICHD) for the pivotal Phase 3 clinical study
- 4Q-2023: Anticipated initiation of subject enrollment in the pivotal Phase 3 clinical study, a single arm, open-label contraceptive efficacy study over 12-months of use (13 menstrual cycles)
The pivotal Phase 3 clinical study will be conducted under a
Cooperative Researchand 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.
Sildenafil Cream, 3.6%
A proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical on-demand administration to treat female sexual arousal disorder and/or female sexual interest/arousal disorder.
- 2Q-2023: Initiated Phase 1 thermography study with expected completion in 2023
- 2Q-2023: Announced positive topline data from exploratory Phase 2b RESPOND clinical study
Activities related to psychometric analyses to further refine the measures and resulting endpoints from the Phase 2b RESPOND study for use in a Phase 3 pivotal clinical study and preparations for data review in an end-of-Phase 2 meeting with the FDA are underway.
A unique, investigational intravaginal ring designed to deliver bio-identical estradiol and progesterone continuously over a 28-day period for the treatment of moderate to severe vasomotor symptoms, as part of menopausal hormone therapy.
- 4Q-2022: Positive topline efficacy data reported from Phase 1/2 clinical study
- 1Q-2023: Positive topline PK data reported from Phase 1/2 clinical study, and plans to progress to a single Phase 3 study announced
- 2H-2023: Activities underway to support an Investigational New Drug application (IND) submission and Phase 3 clinical study initiation
A proprietary, investigational formulation of tamoxifen for intravaginal administration to treat vulvovaginal atrophy in women without the use of hormones.
- 4Q-2022: Positive topline safety, tolerability, PK and pharmacodynamics data reported from Phase 1/2 clinical study
- 2H-2023: Activities underway to support IND submission and Phase 2 clinical study initiation
Financial Highlights for the Quarter ended
- Cash and cash equivalents:
$13.3 millionat June 30, 2023.
- General and administrative expenses:
$2.9 millionin 2Q-2023 as compared to $2.8 millionin 2Q-2022, with the current quarter’s increase primarily attributable to increases in personnel costs, professional services expense, and stock-based compensation expense, partially offset by decreases in general corporate overhead expenses.
- Research and development expenses:
$6.0 millionin 2Q-2023 as compared to $6.8 millionin 2Q-2022, with the current quarter’s decrease primarily attributable to decreases in expenses related to our Sildenafil Cream Phase 2b RESPOND clinical study, and clinical trial and manufacturing and regulatory activities for Ovaprene, partially offset by increases in costs related to development activities for our Phase 1 and Phase 1-ready programs.
2 https://www.cdc.gov/std/bv/stats.htm and https://www.census.gov/data/datasets/2017/demo/popproj/2017-popproj.html, accessed
3 https://www.mayoclinic.org/diseases-conditions/bacterial-vaginosis/symptoms-causes/syc-20352279, accessed
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
To access the conference call via phone, dial (800) 715-9871 (
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. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose
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),
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 expectations regarding the commercial launch of XACIATO in the
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Media on behalf of Daré Bioscience, Inc.:
|Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)|
|Three months ended
|License fee revenue||$||-||$||10,000,000|
|General and administrative||2,920,672||2,792,894|
|Research and development||6,043,684||6,797,784|
|License fee expense||25,000||25,000|
|Total operating expenses||8,989,356||9,615,678|
|Income (loss) from operations||(8,989,356||)||384,322|
|Net income (loss)||$||(8,762,232||)||$||413,998|
|Foreign currency translation adjustments||$||(31,151||)||$||(135,869||)|
|Comprehensive income (loss)||$||(8,793,383||)||$||278,129|
|Income (loss) per common share:|
|Weighted average number of shares outstanding:|
|Condensed Consolidated Balance Sheets Data|
|Cash and cash equivalents||$||13,329,101||$||34,669,605|
|Total stockholders' equity (deficit)||$||(2,719,402||)||$||11,112,110|
Source: Daré Bioscience, Inc.