Full Press Release Details
Bioscience Reports Second Quarter 2023 Financial Results and Provides a Company Update
Call and Webcast Today at 4:30 p.m. ET
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 |
DIEGO August 10, 2023 (GLOBE NEWSWIRE) - Dar Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation,
today reported financial results for the quarter ended June 30, 2023, and provided a company update.
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 Sabrina Martucci Johnson, President and CEO of Dar Bioscience. "The group receiving Sildenafil Cream in the RESPOND
study demonstrated improvements in arousal lubrication, orgasm and sexual desire, which persisted through the end of study assessment.
Based on data from the study, demonstrating improvement in multiple facets of female sexual dysfunction, and because there is no FDA-approved
product for the treatment of female sexual arousal disorder or female sexual interest/arousal disorder, Sildenafil Cream has the potential
to be a first-in-category product with a market opportunity comparable in size to the erectile dysfunction market."
also remain very enthusiastic about rest of 2023 given two highly anticipated milestones," said Ms. Johnson. "First, we are
on track to begin patient enrollment in what we believe will be the single pivotal Phase 3 study for Dar 's late-stage portfolio
candidate, Ovaprene, an investigational, hormone-free, monthly intravaginal contraceptive designed to be an easy-to-use monthly option
with effectiveness approaching hormonal methods and whose U.S. commercial rights are under a license agreement with Bayer. Second, we
are looking forward to the U.S. commercial launch of XACIATOTM by our global collaboration partner, Organon. Finally, later
this year we expect to announce the topline findings from our DARE-PDM1 Phase 1 trial, a multi-center, randomized, placebo-controlled,
double-blind, 3-arm parallel group study of approximately 36 healthy, premenopausal women with primary dysmenorrhea, also referred to
as menstrual cramps and pain. Prevalence rates of dysmenorrhea vary but range from 50% to 90%. Recent market research suggests that the
global market for dysmenorrhea treatment was valued at $13 billion in 2022 and is expected to increase to $28.5 billion by 2029¹."
In Review and 2H-2023 Anticipated Developments
| One FDA approved product, XACIATO TM | ||
| 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 |
(clindamycin phosphate) vaginal gel, 2%
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.
| 3Q-2022: $10.0 million cash payment received under commercial license agreement with Organon | ||
| 2H-2023 : $1.0 million cash received, and $1.8 million milestone anticipated upon 1 st 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 |
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 Research and 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. |
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. |
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 |
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 |
Highlights for the Quarter ended June 30, 2023
| Cash and cash equivalents: $13.3 million at June 30, 2023. | ||
| General and administrative expenses: $2.9 million in 2Q-2023 as compared to $2.8 million in 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 million in 2Q-2023 as compared to $6.8 million in 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. |
accessed 5 August 2023
accessed 5 August 2023
https://www.mayoclinic.org/diseases-conditions/bacterial-vaginosis/symptoms-causes/syc-20352279, accessed 5 August 2023
will host a conference call and live webcast today at 4:30 p.m. Eastern Time to review financial results for the quarter ended June 30,
2023 and to provide a company update.
access the conference call via phone, dial (800) 715-9871 (U.S.) or (646) 307-1963 (international). The conference ID number for the
call is 8451277. To listen to the event and view the presentation slides via live webcast, join from the Investors section of the Company's
website at http://ir.darebioscience.com under "Presentations, Events & Webcasts." Callers will be able to access
the presentation slides at the same location on the Company's website. Please log in approximately 5-10 minutes prior to the call
to register and to download and install any necessary software. The webcast and presentation slides will be archived under "Presentations,
Events & Webcasts" in the Investors section of the Company's website at http://ir.darebioscience.com and available
for replay until August 24, 2023.
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.
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. Dar '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 (FSAD) and/or female sexual interest/arousal disorder (FSIAD) utilizing
the active ingredient in Viagra ; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal
hormone therapy. To learn more about XACIATO, Dar 's full portfolio of women's health product candidates, and Dar 's
mission to deliver differentiated therapies for women, please visit www.darebioscience.com.
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), SEC filings, press releases, public conference calls and webcasts. Dar
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 and product candidates, clinical trials and other matters. The information Dar
posts on its investor relations website or through social media channels may be deemed to be material information. Dar encourages
investors, the media, and others interested in the company to review the information Dar 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 in the Investors section of Dar 's website.
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 U.S., including the timing of the first commercial sale of XACIATO, plans and expectations
with respect to Dar 's product candidates, including anticipated timing for commencement and conduct of clinical trials
and announcement of topline results, the potential for FDA approval of a product candidate based on a single pivotal clinical study,
the expectation that a product candidate could be a first-in-category product, and the potential market size and opportunity for a product
candidate, if approved. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Dar 's
actual results, performance or achievements to be materially different from future results, performance or achievements expressed or
implied by the forward-looking statements in this press release, including, without limitation, risk and uncertainties related to: Dar 's
ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue
as a going concern; Dar 's ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product
candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product
candidate; Dar 's ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to
meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety
and efficacy of its product candidates; Dar 's dependence on third parties to conduct clinical trials and manufacture and
supply clinical trial material and commercial product; the risk that positive findings in early clinical and/or nonclinical studies of
a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that
development of a product candidate requires more clinical or nonclinical studies than Dar anticipates; the loss of, or inability
to attract, key personnel; the effects of the COVID-19 pandemic, macroeconomic conditions and geopolitical events on Dar 's