Daré Bioscience Reports Third Quarter 2019 Financial Results and Provides Company Update
“The third quarter was marked by tremendous progress for Daré and positioned us to reach a number of milestones in the fourth quarter of 2019 and into 2020,” said
“In the third quarter, we also advanced our DARE-BV1 and Sildenafil Cream, 3.6% programs,” continued Ms. Johnson. ”We completed the non-interventional study to support the content validity of patient reported outcome measures for our Phase 2b and Phase 3 clinical studies of Sildenafil Cream, 3.6%, our novel cream formulation of sildenafil with potential to be the first
“This week, we were also pleased to have announced a definitive agreement to acquire Microchips Biotech, including its innovative contraceptive program supported by up to
- Cash and cash equivalents:
-- As of September 30, 2019, cash and cash equivalents were approximately
March 2019, Daré received a Notice of Award for an additional $982,851of the anticipated $1.9 milliongrant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The grant serves to offset certain Ovaprene development expenses, and during the third quarter, Daré recorded grant funding of approximately $231,000as a reduction to research and development expense.
- General and administrative expenses were approximately
$1.3 millionfor the third quarter of 2019, as compared to approximately $1.2million for the same period in 2018.
- Research and development expenses were approximately
$2.0million for the third quarter of 2019, as compared to approximately $1.4million for the same period in 2018. The increase is primarily attributable to costs related to development of DARE‑BV1 and Ovaprene, including activities to prepare for the Phase 3 clinical study of DARE‑BV1 and to conduct the PCT clinical study of Ovaprene, and personnel costs.
- License expenses for the third quarter of 2019 were approximately
$133,000, as compared to zero for the same period in 2018. These expenses reflect accruals of fees payable under license agreements that Daré entered into in 2018 relating to the DARE-BV1 program and the intravaginal ring drug delivery technology programs, including DARE-HRT1 and DARE-FRT1.
- Daré reported a comprehensive loss of approximately $3.4 million for the third quarter of 2019, as compared to approximately $2.6 million for the same period in 2018. The increase is primarily due to the increases in the company’s operating expenses summarized above.
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 September 30, 2019 and to provide a company update.
To access the conference call via phone, dial (844) 831-3031 (U.S.) or (443) 637-1284 (international). The conference ID number for the call 3154847. The live webcast can be accessed under “Events & Presentations" in the Investor Relations section of the company's website at www.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. To access the replay, please call (855) 859-2056 (U.S.) or (404) 537-3406. The conference ID number for the replay is 3154847. The call and webcast replay will be available until November 21, 2019.
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 vaginal contraceptive; 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 the company's website mentioned above.
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,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating Daré’s plans to initiate a contraceptive effectiveness and safety study of Ovaprene in the second half of 2020 and the potential for that study to be a pivotal study, consummation of the merger transaction with Microchips, the anticipated amount of Microchips’ cash balance at the time of closing of the transaction, the potential for up to
Investors on behalf of Daré
Media on behalf of Daré
Source: Daré Bioscience
|Daré Bioscience, Inc. and Subsidiaries|
|Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended
September 30, 2019
|Nine Months Ended
September 30, 2019
|General and administrative||1,318,986||$||1,175,049||3,903,545||$||3,635,413|
|Research and development expenses||1,966,230||1,446,548||6,172,192||4,750,823|
|Impairment of goodwill||-||-||-||5,187,519|
|Total operating expenses||3,418,549||2,621,597||10,484,070||13,923,755|
|Loss from operations||(3,418,549||)||(2,621,597||)||(10,484,070||)||(13,923,755||)|
|Other income (expense)||25,471||47,122||86,703||101,492|
|Deemed dividend from trigger of down round provision feature||$||-||$||-||$||(789,594||)||$||-|
|Net loss to common shareholders||$||(3,393,078||)||$||(2,574,475||)||$||(11,186,961||)||$||(13,822,263||)|
|Foreign currency translation adjustments||$||(15,378||)||$||(18,721||)||$||(15,674||)||$||(59,952||)|
|Loss per common share - basic and diluted||$||(0.20||)||$||(0.23||)||$||(0.76||)||$||(1.32||)|
|Weighted average number of common shares outstanding:|
|Basic and diluted||16,683,411||11,422,161||14,756,213||10,499,982|
|Daré Bioscience, Inc. and Subsidiaries|
|Consolidated Balance Sheets|
|September 30, 2019||December 31, 2018|
|Cash and cash equivalents||$||2,435,120||$||6,805,889|
|Total stockholders' equity||$||1,809,992||$||6,726,620|
Source: Dare Bioscience, Inc.