Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (January 2024)
37 slides from Dare Bioscience's investor presentation, Jan 8, 2024
Slide 1: Transforming Women's Health
b doré DARE IN ENGLISH, IT MEANS “TO BE BOLD.” Transforming IN ITALIAN, IT MEANS “TO GIVE.” Women’s Health We founded Daré Bioscience with the sole focus of putting women’s health first — to boldly address existing therapeutic gaps and give women the novel treatment options they want and need. Janua
Slide 2: Forward-Looking Statements; Disclaimers
doré Forward-Looking Statements; Disclaimers This presentation is for informational purposes only and is not an offer to sell ora 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 st
Slide 3: An Efficient Investment Thesis
doré Women’s Health An Efficient Investment Thesis Transforming women’s health by advancing high-impact, first-in-category product candidates that have already demonstrated proof of concept. Global R&D Commercial opportunity * Approximately 1% of We believe investment in women’s healthcare research
Slide 4: The Daré value proposition
b doré The Daré value proposition We leverage the insights and efficiencies of a deep vertical to mitigate risk and efficiently bring high-impact products to market with commercial collaborators We deploy established active pharmaceutical ..and we have completed successful clinical trials with six i
Slide 5: Innovative treatments that women want and need
0) Innovative treatments that women want and need Our investigational products are some of the most potentially disruptive therapeutic candidates for women in decades ADDRESSABLE MARKET ASSET (millions of women) a Gel to treat bacterial vaginosis 23 2 Monthly hormone-free contraceptive 35 3 Topical
Slide 6: Innovative treatments that women want and need
0) doré Innovative treatments that women want and need Our investigational products are some of the most potentially disruptive therapeutic candidates for women in decades ADDRESSABLE. PHASE3/ REGULATORY FDA ASSET MAREET — nee ra? PIVOTAL SUBMISSION APPROVED (millions of women) is ul aioe 2 (clindam
Slide 7: XACIATO (Clindamycin Phosphate) Vaginal Gel 2%
doré XACIATO™ (Clindamycin Phosphate) Vaginal Gel 2% Daré’s first FDA-approved product XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal gel 2% is a lincosamide antibacterial © «—— indicated for the treatment of bacterial vaginosis (BV) in females 12 In less than five years since licensing th
Slide 8: Ovaprene
doré Ovaprene® Investigational intravaginal hormone-free, monthly contraceptive Daré’s potential first-in-category contraceptive product Designed to be an easy-to-use monthly option with effectiveness approaching hormonal methods. — There are currently no FDA-approved monthly, hormone-free contracep
Slide 9: Sildenafil Cream, 3.6%
doré Sildenafil Cream, 3.6% Investigational topical formulation of the active ingredient in Viagra® Commercial Rights Not Yet Partnered Daré’s potential first-in- category treatment for female sexual arousal disorder (FSAD). There are currently no FDA approved treatments for FSAD. FSAD is characteri
Slide 10: Earlier Stage Programs with Grant Funding Enhance the Pipeline
Earlier Stage Programs with Grant Funding Enhance the Pipeline Vaginal diclofenac once-daily thermosetting hydrogel Etonogestrel contraceptive injection once every 6-12 months Bio-identical progesterone delivery via intravaginal ring Levonorgestrel releasing implant that can be remotely paused and r
Slide 11: Upcoming Milestones
doré Upcoming Milestones XACIATO™ (Clindamycin Phosphate) Vaginal Gel 2% — Quarterly sales and launch updates Ovaprene® — Phase 3 study recruitment and data updates Sildenafil Cream, 3.6% — End of Phase 2 meeting FDA feedback; Phase 3 design, development, and collaboration strategy updates u
Slide 12: Appendix
Appendix
Slide 13: XACIATO (Clindamycin Phosphate) Vaginal Gel 2%
doré XACIATO™ (Clindamycin Phosphate) Vaginal Gel 2% One-time intravaginal administration XACIATO is indicated for the treatment of bacterial vaginosis in females 12 years of age and older. See Full Prescribing Information for the safe and effective use of XACIATO. See XACIATO selected safety inform
Slide 14: Bacterial Vaginosis: Daré Innovation XACIATO
0) doré > Clinical Issue Bacterial Vaginosis Daré Innovation: XACIATO™ (Clindamycin Phosphate) Vaginal Gel 2%* Recurring infection, difficult to treat effectively Most common vaginal condition in women ages 15-44 Estimated to affect ~23 million women in the US» Bacterial Vaginosis increases health r
Slide 15: XACIATO Selected Safety Information
©. XACIATO Selected Safety Information + XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. + Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may rang
Slide 16: Ovaprene
b doré Ovaprene® Investigational potential first-in- category, hormone- free, monthly birth control BAYER) U.S. Commercialization Collaborator i) Phase 3 Development Collaborator 36
Slide 17: Contraception: Market Opportunity
i Contraception: Market Opportunity Successful Contraceptive Brands Peak Sales: Women in the Reproductive Health & Contraception Market Segment (over 60 million women) ay Population of women 15-44 years by ag Mirena® Hormone UD Le Loestrin® error naa te 56 (rrethindrnesertate andes US, 2020 "Piya in
Slide 18: Ovaprene Potential Market Opportunity
© Ovaprene® - Potential Market Opportunity»? Potential Candidates for Ovaprene® 22Miillion 22 Million Current Current Non-Users. Prod + Pill(ao.3M) + Injectable (2.5M) + Vaginal Ring (2.0M) + Patch (0.2M) Currently use no contraception + Sexually active + Not seeking pregnancy 22 Million Current Hor
Slide 19: Contraception: What's Missing from Current Hormone-Free Options?
Contraception: What's Missing from Current Hormone-Free Options? Pregnancies Expected Hormone-free Options (pera00 women) ** Least Effective Spermicides on & Vaginal Gels? v Condoms (male) 6 Diaphragms a with a spermicide) . ad (with cide) | ap Copper UD zi | Most Effective
Slide 20: Ovaprene Investigational Hormone-Free, Monthly Contraceptive
©. Ovaprene® Investigational Hormone-Free, Monthly Contraceptive Physical Barrier® Three-dimensional, knitted polymer barrier Spermiostatic Environment® Contraceptive-loaded silicone ring releasing non-hormonal active Ferrous gluconate Desired Features of Birth Control Products:*+ Design Features of
Slide 21: Ovaprene - Pre-Pivotal Study
Ovaprene® - Pre-Pivotal Study The Pre-pivotal Postcoital Test (PCT) Clinical Study Met its Primary Endpoint Ovaprene prevented the requisite number of sperm from reaching the cervix across all women and all cycles evaluated. Specifically, in 100% of women and cycles, an average of less than five (<
Slide 22: Ovaprene - Commercial License Agreement with Bayer
doré Ovaprene® - Commercial License Agreement with Bayer January 2020 - Bayer, which markets the $1 billion Mirena contraceptive franchise, and Daré announced the execution of a license agreement under which Bayer may commercialize Ovaprene Mirena’ is the # investigational contraceptive in the US on
Slide 23: Ovaprene - Collaborative Research Agreement with NIH
0) doré Ovaprene® - Collaborative Research Agreement with NIH "This collaboration between Daré and NICHD marks an important milestone in Women’s Healthcare Innovation. Women are at the center of everything we do and we are so pleased to continue to partner with Daré in support of our mission We're F
Slide 24: Ovaprene - U.S. Regulatory Strategy
Ovaprene® - U.S. Regulatory Strategy? Premarket approval (PMA) strategy The Center for Devices and Radiological Health (CDRH) as lead review division Based on our communications to date Pivotal study design: with the FDA, if successful, we believe This is a non-comparative study meaning all women wi
Slide 25: Sildenafil Cream, 3.6%
doré Sildenafil Cream, 3.6% Investigational topical formulation of the active ingredient in Viagra® Potential First-In-Category treatment for Female Sexual Arousal Disorder (FSAD) - there are no FDA approved treatments for FSAD Designed to increase local blood flow to promote improved genital arousa
Slide 26: FSAD - The Clinical Issue & Prevalence
doré FSAD-The Clinical Issue & Prevalence Female Sexual Arousal Disorder (FSAD) is characterized primarily by inability to attain or maintain sufficient genital arousal during sexual activity. Of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction
Slide 27: Oral Sildenafil provided a compelling proof of concept for FSAD
0) doré Oral Sildenafil provided a compelling proof of concept for FSAD ‘Statistically significant increases in Vaginal Pulse Amplitude (VPA): Pfizer VPA Clinical Lab Study ~ Oral Viagra ‘Mean and Maximus VPAt Statistically significant improvement in genital stimulation (FED) Pfizer Clinical Field S
Slide 28: Sildenafil Cream, 3.6% - Phase 1 and Phase 2a Study Results
doré Sildenafil Cream, 3.6% - Phase 1 and Phase 2a Study Results Phase a Study of SST-6007 (Sildenafil Cream, 3.696)* Normal healthy postmenopausal women were dosed with escalating doses of Sildenafil Cream, 3.6%, using a cross-over study design Sildenafil Cream had significantly lower systemic expo
Slide 29: Sildenafil Cream, 3.6% - Thermography Study Results
0) \~* Sildenafil Cream, 3.6% - Thermography Study Results* Demonstrated time to effect (11-15 minutes) Positive cognitive arousal responses were noted. Significantly greater increases in genital temperature after application of Sildenafil Cream compared to placebo cream Significantly greater self-r
Slide 30: Overview of Phase 2b Study
© Overview of Phase 2b Study Phase 2b, Exploratory, Randomized, Placebo-Controlled, Trial of Sildenafil Cream 3.6% for the Treatment of Female Sexual Arousal Disorder in Healthy Premenopausal Women (#NCT04948151) - N=200 Randomized, 101 Sildenafil Cream vs 99 Placebo Active | Over 10,000 women _ app
Slide 31: Phase 2b Study Objectives Overview
doré | Phase 2b Study Objectives Overview * The Phase 2b was not only the first at-home study with Sildenafil Cream, 3.6%, it was the first study specifically evaluating a potential therapy for FSAD as an indication. * As such, the objectives included: * Characterization of sexual response impacted
Slide 32: Phase 2b Post-Hoc Analyses
Phase 2b Post-Hoc Analyses Informal post-hoc analyses were conducted on enrollment FSD diagnosis category so that efficacy could be evaluated in the study sub-populations based on concomitant diagnoses, such that the patient population most likely to benefit from the mechanism of action of Sildenafi
Slide 33: DARE-HRT1
doré DARE-HRT14 Investigational monthly menopausal hormone therapy ‘gos(b)(2) regulatory pathway anticipated. Potential first-in-category vaginal combination hormone delivery for treatment of vasomotor symptoms due to menopause Self-administered 28-day IVR Intravaginal ring (IVR) designed to release
Slide 34: Vasomotor Symptoms of Menopause
0) doré > Vasomotor Symptoms of Menopause Daré Innovation: DARE-HRT1 Monthly Vaginal Ring Inthe US, over 45M women are estimated to be in or approaching menopause; symptoms can last up to 10 years* Clinical + 75% of menopausal women experience hot flashes? Issue + 3 ins menopausal women felt that th
Slide 35: DARE-VVA1
doré DARE-VVA14 Investigational hormone-free vaginal insert for dyspareunia ‘gos(b)(2) regulatory pathway anticipated. Potential first-in-category hormone-free intravaginal treatment for painful intercourse (dyspareunia) associated with vulvar and vaginal atrophy (VVA). Proprietary formulation of ta
Slide 36: DARE-CIN
doré DARE-CIN“ Investigational anti- viral vaginal insert for HPV infection and cervical intraepithelial neoplasia (CIN) ‘sos(b)(2) regulatory pathway anticipated Potential first-in-category, non-surgical, pharmaceutical intervention for the treatment of CIN and other HPV-related pathologies. Propri
Slide 37: Transforming Women's Health
b doré DARE IN ENGLISH, IT MEANS “TO BE BOLD.” Transforming IN ITALIAN, IT MEANS “TO GIVE.” Women’s Health We founded Daré Bioscience with the sole focus of putting women’s health first — to boldly address existing therapeutic gaps and give women the novel treatment options they want and need. Janua
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