Daré Bioscience Reports First Quarter 2020 Financial Results and Provides Company Update
Conference Call Today at
“The first quarter was an active one for Daré, beginning with the commercial licensing agreement with Bayer for Ovaprene and continuing with important progress in advancing the development of each of our later-stage product candidates,” said
First Quarter 2020 Business Highlights
- Ovaprene® – License agreement with Bayer for the
U.S.commercial rights to our investigational hormone-free, monthly contraceptive.
- DARE-BV1 – FDA Fast Track Designation for the treatment of bacterial vaginosis; preparations for Phase 3 study this year.
- Sildenafil Cream, 3.6% – Positive data from thermography study presented at the
International Society for the Studyof Women’s Sexual Health(ISSWSH) Annual Meeting 2020.
First Quarter 2020 Financial Results
- General and administrative expenses were approximately
$1.9 millionfor the first quarter of 2020, as compared to approximately $1.3 millionfor the first quarter of 2019, with the increase due primarily to increased expenses for accounting, legal and professional services and higher personnel and insurance costs.
- Research and development expenses were approximately
$2.4million for the first quarter of 2020, as compared to approximately $1.7million for the first quarter of 2019. The increase was due primarily to expenses related to development activities for DARE-BV1, Ovaprene, DARE-HRT1, and DARE-VVA1, and for the microchip-based contraceptive program acquired in the fourth quarter of 2019, and increased personnel costs, with such expenses partially offset by grant funding related to both Ovaprene and the microchip-based contraceptive program.
- License expenses, which reflect payments due under Daré’s various product license agreements, were approximately
$12,500for the first quarter of 2020, as compared to $112,500for the first quarter of 2019.
- Comprehensive loss for the first quarter of 2020 was approximately $4.3 million, as compared to approximately $3.0 million for the same period in the prior year substantially due to a greater loss from operations in the first quarter of 2020.
- Net cash provided by financing activities for the first quarter of 2020 was approximately
$6.9 million and consisted of net proceeds from sales of common stock in “at-the-market” offerings and proceeds from exercises of warrants and options.
- Cash and cash equivalents were approximately
$5.0 millionat March 31, 2020, compared to approximately $4.8 millionat December 31, 2019.
- Third Notice of Award of approximately
$731,000in grant funding received from the National Institutes of Health for the Ovapreneprogram, with $428,000of that amount received after March 31, 2020as reimbursement of Ovaprene postcoital test clinical study expenses.
- Additional cash of approximately
$2.0 million(net of fees) raised after March 31, 2020from sales of common stock in “at-the-market” offerings. As of May 12, 2020, approximately 26.6 million shares of Daré common stock are outstanding.
- Execution of a purchase agreement with
Lincoln Park Capital Fund, LLCfor the potential sale of up to $15 millionin shares of Daré common stock over a 36-month period at times and in amounts controlled by Daré, subject to the satisfaction of conditions in and the limitations under the agreement.
- Announcement of a partnership agreement with
Health Decisions, Inc., a full-service contract research organization (CRO) with expertise in clinical development of women’s health products, intended to facilitate advancement of key Daré programs in a capital-efficient manner.
COVID-19 Update: Daré continues to monitor the pandemic, its associated restrictions and their potential effects on the company’s business, financial condition and results of operations, including the potential impacts on the company’s planned clinical trials and its ability to raise additional capital when needed. Due to rapidly evolving circumstances, Daré is unable to predict with any reasonable accuracy the full financial and business impact of the pandemic on its business, financial condition or results of operations at this time.
Daré will host a conference call and live webcast today at 4:30 p.m. Eastern Time 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 the advancement of 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 expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility.
Daré’s product portfolio includes potential first-in-category candidates in clinical development: Ovaprene®, a hormone-free, monthly contraceptive intravaginal ring 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 replacement 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 its investor relations 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 on its investor relations website (https://darebioscience.gcs-web.com/) 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,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Daré’s expectations for clinical development of its product candidates, including the timing of commencement and announcement of topline results of planned clinical studies of DARE-BV1, Sildenafil Cream, 3.6% and Ovaprene, the potential for regulatory approval to market DARE-BV1 and Ovaprene based on a single successful Phase 3 study or contraceptive effectiveness and safety clinical study, respectively, Daré’s ability to access up to
Investors on behalf of Daré
Media on behalf of Daré
|Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended
|General and administrative||$||1,861,765||$||1,277,180|
|Research and development expenses||2,379,804||1,693,391|
|Total operating expenses||4,254,069||3,083,071|
|Loss from operations||(4,254,069||)||(3,083,071||)|
|Foreign currency translation adjustments||$||(22,944||)||$||7,621|
|Loss per common share - basic and diluted||$||(0.18||)||$||(0.27||)|
|Weighted average number of common shares outstanding:|
|Basic and diluted||23,799,396||11,422,161|
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||5,047,325||$||4,780,107|
|Total stockholders' equity||$||3,214,183||$||440,826|
Source: Daré Bioscience, Inc.