Full Press Release Details
Bioscience Selected to Receive $10 Million Award from ARPA-H's Sprint for Women's Health
is a potential first-in-category treatment for human papillomavirus (HPV)-related cervical disease which could change the treatment paradigm
for clinical HPV management.
all cervical cancer cases worldwide are caused by HPV infection.
DIEGO, October 23, 2024 (GLOBE NEWSWIRE) -- Dare Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for
the health and wellbeing of women, today announced that it has been selected by the Advanced Research Projects Agency for Health
(ARPA-H) as an awardee of the Sprint for Women's Health to address critical unmet challenges
in women's health, champion transformative innovations, and tackle health conditions that uniquely or disproportionately affect
women. Dare will receive $10 million in funding over two years through the Sprint for Women's Health launchpad track for
later-stage health solutions.
is an innovative investigational treatment for HPV-related cervical disease. Essentially all cervical cancers worldwide are caused by
HPV infection, and despite the advancements in HPV screening and vaccination, an estimated 100,000 women are still treated for cervical
precancer and an estimated 4,000 women still die from cervical cancer in the U.S. every year. Today, cervical precancers are monitored
until they reach a late stage, since the most common treatment is a surgery which removes part of the cervix; however, the surgery is
associated with an increased risk of preterm birth and sexual dysfunction and therefore is not recommended for patients with fertility
has the potential to be the first FDA-approved pharmaceutical intervention that could treat both late-stage cervical lesions as well
as earlier stage HPV-related cervical infections, which could change the paradigm around how HPV-related cervical diseases are clinically
managed today," said Sabrina Martucci Johnson, President and CEO of Dare Bioscience. "We are thrilled that ARPA-H shares
our vision for this product candidate's potential to transform the management of HPV-related cervical diseases with this at-home
strategy to control the virus that causes cervical cancer."
sought solutions within six topics of interest in women's health, and received an unprecedented response of submissions.
ARPA-H launched the Sprint for Women's Health in February, with First Lady Jill Biden announcing the funding as the first
major deliverable from the White House Initiative on Women's Health Research.
ARPA-H Sprint for Women's Health is conducted in collaboration with the Investor Catalyst Hub of ARPANET-H,
the agency's nationwide health innovation network that connects people, innovators, and institutions to accelerate better health
outcomes for everyone. Dare will work with an ARPA-H Program Manager and the Investor Catalyst Hub over two years to develop DARE-HPV,
receiving milestone-based payments aligned to research activities and performance objectives.
ARPA-H launchpad program accelerates transformative health solutions' path to impact by providing funding and market transition
support. As a launchpad performer, Dare will also work with an Entrepreneur-in-Residence and participate in Launchpad Accelerator,
which includes customized curriculum, virtual events, and in-person workshops to support performer market transition.
HPV-Related Cervical Diseases and DARE-HPV
papillomavirus (HPV) is the most common sexually transmitted infection in the United States. Essentially all cervical cancers worldwide
are caused by infection with one of 14 carcinogenic, or "high-risk" HPV types (hrHPV). While some HPV infections are transient,
persistent hrHPV infection can progress to cervical cancer through the persistence and progression of cervical lesions.
is an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert with the potential
to be a first-in-category treatment for HPV-related cervical diseases. There currently are no U.S. Food and Drug Administration (FDA)-approved,
non-surgical pharmaceutical interventions to treat high-grade cervical lesions (also called high-grade squamous intraepithelial lesions
(HSIL) or high-grade cervical intraepithelial neoplasia (CIN 2/3)) and no FDA-approved treatments for HPV infection. DARE-HPV has the
potential to be the first FDA-approved pharmaceutical intervention for the treatment of CIN and other HPV-related cervical pathologies.
the U.S., about 10% of women with HPV infection on their cervix will develop long-lasting HPV infections that put them at risk for cervical
cancer. The American Cancer Society estimates that approximately 13,820 new cases of invasive cervical cancer will be diagnosed and more
than 4,000 women will die from the disease in the U.S. in 2024. Additionally, each year in the U.S., an estimated 100,000 people are
treated for cervical precancer, of which approximately 74% are between the ages of 18-39 years, during prime childbearing and childrearing
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 to emerge from Dar 's portfolio of women's health product candidates is XACIATO
(clindamycin phosphate) vaginal gel 2%, 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. Organon commenced U.S. marketing of XACIATO in the
fourth quarter of 2023. 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, the active ingredient in Viagra , to treat female sexual arousal disorder (FSAD);
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.
Bioscience leadership has been named on the Medicine Maker's Power List and Endpoints News' Women in Biopharma 2022. In 2023,
Dar 's CEO was honored as one of Fierce Pharma's Most Influential People in Biopharma for Dar 's contributions
to innovation and advocacy in the women's health space.
Bioscience placed #1 in the Small Company category of the San Diego Business Journal's 2023 Best Places to Work Awards.
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 X (formerly 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 Dar 's
expectation that it will receive $10 million in funding from ARPA-H, DARE-HPV's potential as a safe and effective treatment for
HPV-related cervical diseases, the potential for DARE-HPV to be the first FDA-approved pharmaceutical intervention for treatment of late-stage
cervical lesions and other HPV-related cervical pathologies, and the potential market opportunity for DARE-HPV, if approved. As used
in this press release, the description of a product candidate as "first-in-category" is a forward-looking statement relating
to the potential of the candidate to represent a new category of product if it were to receive marketing approval for the indication
for which Dar is developing it. 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, risks and
uncertainties related to: Dar 's ability to achieve the product development and other milestones required for it to receive
payments under its ARPA-H funding award; 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 macroeconomic conditions, geopolitical
events, public health emergencies, and major disruptions in government operations on Dar 's operations, financial results
and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Dar 's
product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or
commercial collaborators; failure of Dar 's product or product candidates, if approved, to gain market acceptance or obtain
adequate coverage or reimbursement from third-party payers; Dar 's ability to retain its licensed rights to develop and
commercialize a product or product candidate; Dar 's ability to satisfy the monetary obligations and other requirements
in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its