Daré Bioscience Reports Third Quarter 2022 Financial Results and Provides a Company Update
September 30, 2022: $40.4 millionin cash and cash equivalents
- Ovaprene®: IDE approval from FDA for pivotal Phase 3 study; additional study design considerations being reviewed and implemented to further position the study as the single pivotal study for marketing approval
- DARE-HRT1: Positive topline efficacy data from Phase 1/2 clinical study
- Sildenafil Cream, 3.6%: Completion of subject screening for Phase 2b RESPOND clinical study
Conference Call and Webcast Today at
“During the third quarter, we received
“During the past two months, we had several positive developments related to our clinical-stage candidates. In October, we announced the FDA’s approval of our Investigational Device Exemption application allowing us to conduct a single arm, open-label pivotal contraceptive efficacy study of Ovaprene. We are currently reviewing and implementing additional FDA study design considerations to further position the study to serve as the single pivotal study necessary to support a premarket approval submission to the FDA. In October, we also announced positive topline efficacy data from our Phase 1/2 clinical study of DARE-HRT1, an investigational intravaginal ring to provide bio-identical hormone therapy for the treatment of menopausal symptoms with one IVR delivering both bio-identical progesterone and bio-identical estradiol together over 28 days. In November, we announced the completion of subject screening for our exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% for female sexual arousal disorder and are targeting the second quarter of 2023 to announce topline data.”
“Finally, the teams at Daré and Organon have been diligently working toward a commercial launch of XACIATO in the
2H-2022 Portfolio Accomplishments and 1H-2023 Objectives
- Ovaprene: FDA approved IDE application for pivotal study; investigator meeting for pivotal study to be held in 4Q-2022; initiation of subject recruitment targeted for mid-2023
- DARE-HRT1: Phase 1/2 clinical study topline efficacy data announced 4Q-2022; topline pharmacokinetics (PK) data expected later in 4Q-2022
- DARE-VVA1: Phase 1/2 clinical study topline data expected in 4Q-2022
- Sildenafil Cream, 3.6%: Subject screening completed for Phase 2b RESPOND clinical study in 4Q-2022; topline data targeted for 2Q-2023
- XACIATO: Organon market access team is meeting with
U.S.customers now to review XACIATO and obtain competitive coverage in the bacterial vaginosis marketplace; first commercial sale of XACIATO expected in 1H-2023 in the U.S.
- XACIATO™ (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.
$10 millioncash payment received under license agreement with Organon to commercialize XACIATO
- 4Q-2022: Organon market access team is meeting with
U.S.customers now to review XACIATO and obtain competitive coverage in the bacterial vaginosis marketplace
- 1H-2023: First commercial sale expected
Bacterial vaginosis is the most common cause of vaginitis worldwide. 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
A novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with
- 4Q-2022: FDA approved an Investigational Device Exemption (IDE) application for a single arm, open-label pivotal contraceptive efficacy study over 12-months (13 menstrual cycles) and provided additional study design considerations
- 4Q-2022 (December): Investigator meeting for the pivotal Phase 3 clinical study
- Mid-year 2023: Initiation of subject recruitment for the pivotal Phase 3 clinical study
The planned pivotal Phase 3 clinical study will be conducted under a
- 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.
- 4Q-2022: Completed subject screening for Phase 2b RESPOND clinical study
- 2Q-2023: Topline data announcement targeted for Phase 2b clinical study
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 vasomotor symptoms, as part of hormone therapy following menopause.
- 2Q-2022: Phase 1/2 clinical study initiated in
Australiato evaluate the pharmacokinetics of two versions of DARE-HRT1 and to collect safety, usability, acceptability and symptom-relief data
- 4Q-2022: Positive topline efficacy data reported from Phase 1/2 clinical study; topline PK data expected later in 4Q-2022
A proprietary, investigational formulation of tamoxifen for vaginal administration to treat vulvar and vaginal atrophy in women with or at risk for hormone-receptor positive breast cancer.
- 3Q-2021: Phase 1/2 clinical study initiated in
- 4Q-2022: Topline data from Phase 1/2 clinical study anticipated
Financial Highlights for the Quarter ended
- Cash and cash equivalents:
$40.4 millionat September 30, 2022, compared to $51.7 millionat December 31, 2021.
- General and administrative expenses:
$2.7 millionin 3Q-2022, as compared to $2.2 millionin 3Q-2021, with the current quarter’s increase primarily attributable to an increase in professional services expense.
- Research and development expenses:
$4.5 millionin 3Q-2022, as compared to $10.4 million3Q-2021, with the current quarter’s decrease primarily attributable to decreases in expenses related to the ongoing Sildenafil Cream, 3.6% Phase 2b RESPOND clinical trial, manufacturing and regulatory affairs activities related to Ovaprene, costs related to development activities for XACIATO as a result of the completion of the Phase 3 clinical trial for XACIATO in December 2020, and costs related to development activities for our preclinical programs and Phase 1 and Phase 1-ready programs.
- As of
November 9, 2022: 84.8 million shares of common stock outstanding.
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, fertility, and vaginal and sexual health.
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 hormone therapy following menopause. 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),
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 sources of funding the Company’s operations, plans and expectations with respect to Daré’s product candidates, including anticipated timing for commencement and conduct of clinical trials and clinical trial data readouts and the potential for FDA approval of a product candidate based on a single pivotal clinical study, and expectations regarding the commercial launch of XACIATO in the
Investors on behalf of Daré
Media on behalf of Daré Bioscience, Inc.:
|Consolidated Statements of Operations and Comprehensive Loss|
|Three months ended
||Nine months ended
|License fee revenue||$||—||$||—||$||10,000,000||$||—|
|General and administrative||$||2,651,543||$||2,211,334||$||8,014,424||$||5,949,299|
|Research and development||4,462,250||10,432,603||17,065,497||23,501,098|
|License fee expense||25,000||25,000||75,000||75,000|
|Total operating expenses||7,138,793||12,668,937||25,154,921||29,525,397|
|Loss from operations||(7,138,793||)||(12,668,937||)||(15,154,921||)||(29,525,397||)|
|Gain on extinguishment of note payable||$||0||$||0||0||369,887|
|Foreign currency translation adjustments||$||(230,748||)||$||(63,281||)||$||(375,767||)||$||(79,002||)|
|Loss per common share - basic and diluted||$||(0.08||)||$||(0.18||)||$||(0.18||)||$||(0.45||)|
|Weighted average number of shares outstanding:|
|Basic and diluted||84,822,516||70,775,508||85,553,134||64,196,162|
|Condensed Consolidated Balance Sheets Data|
|Cash and cash equivalents||$||40,389,546||$||51,674,087|
|Total stockholders' equity||$||26,343,772||$||38,754,321|
Source: Daré Bioscience, Inc.