Daré Bioscience Reports Third Quarter 2021 Financial Results and Provides a Company Update
Significant progress on several key clinical and corporate initiatives with the portfolio during the third quarter, including DARE-BV1 NDA acceptance and Ovaprene NIH CRADA for the pivotal Phase 3
Actively advancing clinical development and strategic partnerships to maximize value of pipeline candidates
Conference Call and Webcast Today at
“We’ve continued to make significant progress on several key clinical and strategic corporate initiatives with our portfolio during a rather challenging year,” said
4Q 2021 Key Portfolio Objectives
- DARE-BV1: PDUFA target action date for the NDA of
December 7, 2021
- DARE-BV1: Announce
- Ovaprene®: Submit Investigational Device Exemption (IDE) to the FDA for pivotal clinical study
Portfolio Accomplishments and Expectations for 2021 – 2022
- Daré innovation: Novel, investigational thermosetting bioadhesive hydrogel formulated with clindamycin phosphate 2% as a first-line, single-administration treatment for bacterial vaginosis
- New Drug Application (NDA) accepted for filing and granted priority review by the FDA in 3Q 2021
- PDUFA target action date of
December 7, 2021
U.S.commercialization strategy in 4Q 2021
- Robust market introduction in 1H 2022, if approved
- Sildenafil Cream, 3.6%:
- Daré innovation: Proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical administration to treat female sexual arousal disorder (FSAD)
- Continue Phase 2b RESPOND clinical study in 2021 and 2022
- Daré innovation: Novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer
Announced Collaborative Researchand Development Agreement (CRADA) for a pivotal Phase 3 study in the U.S.with Eunice Kennedy Shriver National Institute of Child Health and Human Development(NICHD), a division of the National Institutes of Health(NIH), in 3Q 2021
- Submit IDE to the FDA for a pivotal Phase 3 clinical study in the
U.S.in 4Q 2021
- Commence the pivotal Phase 3 clinical study in 2022
- Daré innovation: Unique, investigational 28-day intravaginal ring (IVR) containing bio-identical estradiol and bio-identical progesterone for the treatment of vasomotor symptoms and genitourinary syndrome associated with menopause
- Submit data from the Phase 1 clinical study for publication in a peer-reviewed journal and scope our development strategy for DARE-HRT1.
- Daré innovation: Proprietary, investigational formulation of tamoxifen for intravaginal administration to treat vulvar and vaginal atrophy (VVA) in women with or at risk for hormone-receptor positive breast cancer
- Initiated a Phase 1/2 clinical study in
Australiain 3Q 2021
- Report topline data of Phase 1/2 study in 2022
Financial Highlights for period ended
- Cash and cash equivalents:
$45.6 millionat September 30, 2021, compared to $4.7 millionat December 31, 2020.
- Net cash from financing activities during the nine months ended
September 30, 2021was approximately $59.8 million, primarily provided by net proceeds from sales of common stock under the company’s at-the-market offering programs.
- General and administrative expenses were approximately
$2.2 millionin 3Q 2021, as compared to $1.4 millionin 3Q 2020, with the increase primarily attributable to higher costs and expenses in professional services, commercial readiness, personnel, stock-based compensation and insurance.
- Research and development expenses were approximately
$10.4 millionin 3Q 2021, as compared to approximately $6.2 millionin 3Q 2020. The $4.2 millionincrease was primarily attributable to the ongoing Sildenafil Cream, 3.6% Phase 2b RESPOND clinical trial and manufacturing and regulatory affairs activities for Ovaprene®.
- Comprehensive loss for 3Q 2021 was approximately
$12.7 million, as compared to approximately $7.6 millionfor 3Q 2020.
Recent Financial Developments
- As of
November 8, 2021, approximately 76.6 million shares of Daré common stock were outstanding.
Daré will host a conference call and live webcast today at 4:30 p.m. ET to review the company's financial results for the quarter ended
To access the conference call via phone, dial (844) 831-3031 (
About Daré Bioscience
Daré Bioscience is a clinical-stage 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 product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly 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®; DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2% to treat bacterial vaginosis via a single application; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause. To learn more about Daré’s full portfolio of women’s health product candidates, and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.
Daré may announce material information about its finances, 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 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 on the investor relations page of Daré’s website mentioned above.
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,” 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 the belief that current clinical development activities and work being done with strategic partners will maximize the value of Daré’s product candidates, expectations for Daré’s product candidates in 2021 and 2022, including potential FDA approval of the DARE-BV1 NDA, anticipated timing of announcing the commercial strategy for and the commercial launch of DARE-BV1 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
|General and administrative||$||2,211,334||$||1,353,069||$||5,949,299||$||4,772,382|
|Research and development expenses||10,432,603||6,203,753||23,501,098||14,131,007|
|Total operating expenses||12,668,937||7,581,822||29,525,397||18,961,722|
|Loss from operations||(12,668,937||)||(7,581,822||)||(29,525,397||)||(18,961,722||)|
|Other income (expense)||1,508||(986||)||1,686||2,454|
|Gain on loan extinguishment of note payable||-||-||369,887||-|
|Deemed dividend from trigger of down round provision feature||-||(6,863||)||-||(6,863||)|
|Net loss to common shareholders||$||(12,667,429||)||$||(7,589,671||)||$||(29,153,824||)||$||(18,966,131||)|
|Foreign currency translation adjustments||(63,281||)||672||(79,002||)||(10,182||)|
|Loss per common share - basic and diluted||$||(0.18||)||$||(0.24||)||$||(0.45||)||$||(0.69||)|
|Weighted average number of common shares outstanding:|
|Basic and diluted||70,775,508||31,588,152||64,196,162||27,381,508|
|Condensed Consolidated Balance Sheet Data|
|Cash and cash equivalents||$||45,570,781||$||4,669,467|
|Working capital (deficit)||$||32,336,068||$||(676,689||)|
|Total stockholders' equity (deficit)||$||31,888,591||$||(1,151,733||)|
Source: Daré Bioscience, Inc.