Daré Bioscience
DARÉ
IN ITALIAN, IT MEANS "TO GIVE."
IN ENGLISH, IT MEANS "TO BE BOLD."
NASDAQ: DARE | Corporate Presentation: December 8, 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 products and 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" is a forward-looking statement 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: commercialization arrangements for XACIATOTM may not be established on a timely basis or acceptable terms; Daré's reliance on third parties for the commercialization of XACIATO; XACIATO may not be accepted by healthcare providers and patients; XACIATO may not obtain adequate coverage, pricing or reimbursement from third-party payors; risks and uncertainties inherent in Daré's ability to successfully develop, obtain regulatory approval for and monetize its product candidates; Daré's dependence on third parties to conduct clinical trials and manufacture its products and product candidates; Daré's need for additional capital to execute its business strategy; and those risks and uncertainties 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.
2
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, fertility, and vaginal and sexual health.
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-concept and/or ability to leverage a 505(b)(2) regulatory pathway,
First-in-category or first-line potential,
and
Opportunity to personalize for women with novel, convenient routes of administration.
3
Daré Bioscience: A Compelling Opportunity
Company Highlights
Diverse pipeline with independent outcomes
- One FDA-approved product and several clinical development stage or Phase 1- ready candidates utilizing different APIs and targeting different indications
Multiple novel delivery platforms
- Persistent unmet needs require creative new approaches designed for her
Compelling market potential
- First-lineor first-in-category product opportunities across the portfolio
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)
- DARE-BV1NDA submission to FDA (bacterial vaginosis)
- DARE-HRT1Phase 1 study topline data (hormone therapy)
- DARE-VVA1Phase 1/2 study commence (vaginal atrophy treatment for women with breast cancer)
- XACIATOTM (clindamycin phosphate) vaginal gel, 2% (f/k/a DARE-BV1) NDA approval
2022 | ● XACIATO U.S. commercial launch |
- Ovaprene® pivotal Phase 3 study commence (hormone-free monthly contraception)
- DARE-VVA1Phase 1/2 study topline data
- Sildenafil Cream, 3.6% Phase 2b study topline data target date announcement pending interim analysis for study sizing
- = currently anticipated timing
4
Advancing Products Women Want - The Portfolio Snapshot
PRE- | PHASE 1 | PHASE 2 | PHASE 3 / | REGULATORY | FDA Approved |
CLINICAL | PIVOTAL | FILING | |||
XACIATOTM Bacterial Vaginosis
NDA approved Dec. 7, 2021
Ovaprene® Hormone-Free, Monthly Contraception
Pivotal Phase 3 Study to Commence 2022*
Sildenafil Cream, 3.6% ^ Female Sexual Arousal Disorder
Phase 2b Study Commenced 2021
DARE-HRT1^ Hormone Therapy
Phase 1 Study Topline Data Announced June 2021
DARE-VVA1^ Vulvar and Vaginal Atrophy
Phase 1 /2 Study Commenced 2021
DARE-FRT1^ Pregnancy Maintenance
Phase 1 Study Preparation
DARE-LARC1^ Long-Acting, Reversible Personal
Contraceptive System
ADARE 204/214 ^ 6 & 12-Month
Injectable Contraception
DARE-RH1 Male or Female
Contraceptive Target | 5 |
^505(b)(2) regulatory pathway anticipated.
*Currently anticipated timing
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Dare Bioscience Inc. published this content on 08 December 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 December 2021 14:11:06 UTC.