Daré Bioscience
DARÉ
IN ITALIAN, IT MEANS "TO GIVE."
IN ENGLISH, IT MEANS "TO BE BOLD."
NASDAQ: DARE | Corporate Presentation: September 9, 2021 | ©2021 Daré Bioscience | All rights reserved |
www.darebioscience.com | ||
Forward-Looking Statements; Disclaimers
This presentation is for informational purposes only and is not an offer to sell or a solicitation of an offer to buy any securities of Daré Bioscience, Inc. ("Daré" or the "Company"). This presentation includes certain information obtained from trade and statistical services, third- party publications, and other sources. Daré has not independently verified such information and there can be no assurance as to its accuracy.
All statements in this presentation, other than statements of historical fact, are forward-looking statements within the meaning of federal securities laws. In some cases, you can identify forward-looking statements by terms such as "may," "will," "expect," "plan," "anticipate," "strategy," "designed," "could," "intend," "believe," "estimate," "target," or "potential," or the negative of these terms and other similar expressions. Such statements include, but are not limited to, statements relating to the clinical and market potential of Daré's product candidates, clinical trial advancement, timing and data, regulatory approval and commercialization, potential collaborations, benefits of a collaboration, pipeline expansion, and potential funding and financing transactions. As used in this presentation, "first-in-category" and "first-line" are forward-looking statements relating to market potential of a product candidate if it were to receive regulatory approval for the indication(s) for which it is being developed. None of the product candidates presented herein are approved for use outside of clinical trials. The timing of clinical trials, clinical trial data, FDA review and approval, collaborations and other milestones and events relating to development and commercialization of Daré's product candidates, other than those having occurred prior to the date of this presentation, are forward-looking statements. Forward-looking statements reflect management's estimates and expectations based on current information and involve risks, uncertainties and assumptions that may cause Daré's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements, including, without limitation, as a result of risks and uncertainties inherent in Daré's business and those described in Daré's most recent annual report on Form 10-K and quarterly report on form 10-Q filed with the Securities and Exchange Commission under the heading "Risk Factors." All forward-looking statements are current only as of the date of this presentation. Daré does not undertake any obligation to update any forward-looking statement in this presentation to reflect new information, future developments or otherwise, except as required by law.
All trademarks, service marks or trade names appearing in this presentation are the property of their respective owners. Unless specifically identified as such, Daré's use or display of third-party marks is not intended and does not indicate or imply any relationship with or endorsement or sponsorship of Daré by the third-party owner.
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Women's Health is Our Sole Focus
Daré Bioscience is a clinical-stage biopharmaceutical company committed to addressing the lack of innovation in women's health primarily in the areas of contraception, vaginal health, sexual health, and fertility.
We work to accelerate innovative product options in women's health that…
Expand treatment options, Enhance outcomes, and Improve ease of use for women.
We partner to…
Drive innovation and develop new solutions,
Accelerate novel products to address persistent unmet needs in a time and capital efficient manner, and
Become a pipeline resource for large and emerging commercial companies.
We look for differentiated investigational products with…
Attractive market opportunities + unmet medical needs,
Prior human proof-of-conceptand/or ability to leverage a 505(b)(2) regulatory pathway,
First-in-categoryor first-linepotential, and
Opportunity to personalize for women with novel, convenient routes of administration.
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Daré Bioscience: A Compelling Opportunity
Company Highlights
1 | Diverse pipeline with independent outcomes |
Several programs, including an NDA stage and four clinical | |
development stage or Phase 1-ready candidates utilizing different | |
APIs and targeting different indications | |
2 | Multiple novel delivery platforms |
Persistent unmet needs require creative new approaches | |
designed for her | |
3 | Compelling market potential |
First-line or first-in-category product opportunities across | |
the portfolio | |
4 | 505(b)(2) FDA pathway planned for most candidates |
Use of well-characterized APIs expected to mitigate | |
development risk, time, and cost | |
5 | Commercial value in women's health evidenced by recent |
transformational pharma transactions |
Program Milestones
2021 | ü | Sildenafil Cream, 3.6% Phase 2b |
study commence (female sexual | ||
arousal disorder) | ||
ü | DARE-BV1 NDA submission to FDA | |
(bacterial vaginosis) | ||
ü | DARE-HRT1 Phase 1 study topline | |
data (hormone therapy) | ||
● | DARE-VVA1 Phase 1 study | |
commence (vaginal atrophy | ||
treatment for women with breast | ||
cancer) | ||
● | DARE-BV1NDA PDUFA target * | |
2022 | ● | DARE-BV1 U.S. commercial launch |
● | Ovaprene® pivotal Phase 3 study | |
commence (hormone-free monthly | ||
contraception) | ||
● | DARE-VVA1 Phase 1 study topline | |
data | ||
● | DARE-FRT1 Phase 1 study | |
commence (preterm birth and IVF | ||
luteal phase support) |
• = currently anticipated timing
* Priority review designation granted by the FDA, PDUFA target action date is | 4 |
December 7, 2021
Advancing Products Women Want - Late Stage Programs
PARTNERS | Product | PRE- | PHASE 1 | PHASE 2 | PHASE 3 / | REGULATORY |
Candidate | CLINICAL | PIVOTAL | FILING | |||
DARE-BV1^ Bacterial Vaginosis- Phase 3 Topline Data Announced December 2020, NDA submitted 2Q2021, PDUFA target December 7, 2021
Investigational thermosetting bioadhesive hydrogel single-administration vaginal treatment for bacterial vaginosis. In the DARE-BVFREE Phase 3 study, DARE-BV1 demonstrated the potential for improved clinical cure rates versus current branded FDA-approved products for the treatment of bacterial vaginosis.
Ovaprene® Hormone-Free, Monthly Contraception-
Pivotal Phase 3 Study commence 2022
Investigational hormone-free monthly intravaginal contraceptive designed to be an easy-to-use monthly option with effectiveness approaching hormonal methods; commercial partnership agreement with Bayer. There are currently no FDA-approved monthly hormone-free contraceptives.
Sildenafil Cream, 3.6%^ Female Sexual Arousal Disorder-
Phase 2b study commence 2021
Investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical administration to treat FSAD. FSAD is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal during sexual activity, for which there are no FDA-approved treatments. Of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction in men.
^505(b)(2) regulatory pathway anticipated.
Potential first-line option for
bacterial vaginosis Bioadhesive gel, clindamycin 2%
Potential first-in-category contraception Self-administeredintravaginal drug/device
Potential first-in-category treatment for female sexual arousal disorder (FSAD)
Topical cream, same active ingredient as Viagra®
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Dare Bioscience Inc. published this content on 09 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 September 2021 16:01:02 UTC.