Slide 1: Corporate Presentation: November 3, 2022
) : : Exhibit 99.1 d Dare Bioscience an G. DARE IN ITALIAN, IT MEANS “TO GIVE.” IN ENGLISH, IT MEANS “TO BE BOLD.” NASDAQ: DARE www.darebioscience.com Corporate Presentation: November 3, 2022 ©2022 Daré Bioscience | All rights reserved
Slide 2: Forward-Looking Statements; Disclaimers
AL || Forward-Looking Statements; Disclaimers ee ee rk ee ce ee PEETTPEEEEETEEET ETE |) EP WINNIE HAIL 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 present
Slide 3: Women's Health is Our Sole Focus
en’s Health is Our Sole Focus Daré Bioscience is a biopharmaceutical company committed to addressing the lack of innovation in women’s health with differentiated products that address unmet needs primarily in the areas of contraception, fertility, and vaginal and sexual health. We work to accelerate
Slide 4: Women's Health — An Efficient Investment Thesis
en’s Health — An Efficient Investment Thesis We believe investment in women’s health Approximately 1% of healthcare research is will be efficient and invested in female-specific conditions disproportionately impactful: beyond oncology. - Women’s Health products make up 27% of total blockbuster produ
Slide 5: Women's Health — Compelling Markets Where Innovation Matters
Women’s Health — Compelling Markets Where Innovation Matte Contraception ~73 Million women ages 15-49* as hormonal monthly IVR, NuvaRing, ~$900M at peak? as hormonal IUD, Mirena franchise, ~$1.2B at peal? a copper IUD, still ~s200M/yr 40 years post launch* Sexual Health - No FDA approved product for
Slide 6: Daré Portfolio — The Big Ideas
Daré Portfolio — The Big Ideas* Contraception Ovaprene © - a Hormone-free, Monthly Contraceptive ADARE-204/214 - 15*6 & 12-Month Injectable Contraceptive DARE-LARCa - 1 Long-Acting, Reversible Personal Contraceptive System DARE-RHa - Hormone-free contraceptive target for women and men Sexual Health
Slide 7: Daré Bioscience: A Compelling Opportunity
Daré Bioscience: A Compelling Opportunity Meaningful market potential for differentiated products First-line or first-in-category product opportunities across the portfolio Remaining Program Milestones in 2022* Diverse pipeline with independent outcomes One FDA-approved product and several clinical
Slide 8: Advancing Products Women Want - The Portfolio Snapshot
Advancing Products Women Want - The Portfolio Snapshot d daré PHASE 3/ REGULATORY FDA ERE-CLINICAL BHASEs PHASE 2 PIVOTAL SUBMISSION APPROVED XACIATO™ “te ORGANON NDA Approved Dee. 7, 2028 z ‘Ovaprene® Ae Hormone-Free, Monthly Contraception 4 Pivotal Phase 3 Study IDE approved Sildenafil Cream, 3.6%
Slide 9: FDA Approved — XACIATO
FDA Approved — XACIATO XACIATO™ (Clindamycin Phosphate) Vaginal Gel, 2% NDA approved December 7, 2021 QIDP, Fast Track and Priority Review Designations Commercialization Collaborator “i ORGANON * XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicate
Slide 10: Advancing Products Women Want - Late Stage Programs
Advancing Products Women Want - Late Stage Programs Ovaprene® Hormone-Free, Monthly Contraception cr Potential first-inseategery hormone- Pivotal Phase 3 Study to Commence 2023* free contraception Self-administered intravaginal * Investigational hormone-free, monthly intravaginal contraceptive. drug
Slide 11: Advancing Products Women Want - Phase 1 and Preclinical
Advancing Products Women Want - Phase 1 and Preclinical Hormone Therapy - Phase 1 Completed; Pregnancy Maintenance Vulvar and Vaginal Atrophy Phase 1/2 Study Completed Phase a Study Preparation Phase 1/2 Study Commenced 1. First-in-category combination hormone delivery for 1. First-in-category proge
Slide 12: Daré: Advancing Products Women Want
Daré: Advancing Products Women Want Innovative women's Every program, if Experienced Board of Directors Woineiisiiealtt health pipeline with approved, represents and Management Team with eneratinamore i i ial first-li demonstrated success in clinical generating multiple upcoming a potential first-li
Slide 13: Experienced Management & Board of Directors
Experienced Management & Board of Directors Management Team Board of Directors pabrina Martucc so bnsoDy William Rastetter, PhD Greg Matz, CPA iS Chairman President & CEO John Fair Cheryl Blanchard, PhD Sophia N. Ononye-Onyia, PhD, Chief Strategy Officer MPH, MBA Lisa Walters-Hoffert Chief Financial
Slide 14: Daré Financial Highlights
Daré Financial Highlights a > Recent Updates: Snapshot: + 30-22 through 8/8/22: $18.0 M cash receivedas F described below Cash and equivalents 6/30/22: $32.1 M Organon global license agreement for XACIATO™: Common shares o/s (8/8/22): 84.7 M . o 20-22: agreement became effective Warrants o/s: 1.6 M
Slide 15: Daré — Working to Accelerate Innovation in Women's Health
Daré — Working to Accelerate Innovation in W Program Milestones remaining in 2022*: po Ovaprene® (hormone-free monthly contraception) Pivotal Phase 3 study investigator meeting 12/2022; recruitment initiation mid-2023* DARE-VVAs2 (vaginal atrophy treatment for women with breast cancer) Phase 1/2 stu
Slide 16: Commercialization Collaborator
Commercialization Collaborator:
Slide 17: Bacterial Vaginosis
Bacterial Vaginosis d (- ro Recurring infection, difficult to treat effectively >) * Most common vaginal condition in women ages 15-44 _ + — Affects ~21 million women in the US? Clinical Issue ‘ reer . , — ; , + Bacterial Vaginosis increases health risks2, including increased risk of preterm birth,
Slide 18: XACIATO: Overview
XACIATO: Overview » XACIATO [zah-she-AH-toe] (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. > This marks the first FDA-approved product in Daré’s portfolio of potential QIDP, Fast
Slide 19: XACIATO - Commercial License Agreement with Organon
XACIATO - Commercial License Agreement with Organon? March 2022 - Organon and Daré announced they entered into an /— agreement whereby Organon will license * The license became effective June 2022. global rights to XACIATO. The license : * Daré received a $10 million upfront payment from Organon bec
Slide 20: XACIATO Important Safety Information
XACIATO Important Safety Information* Indication XACIATO (clindamycin phosphate) vaginal gel is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. Dosage & Administer one applicatorful (5 g of gel containing 100 mg of clindamy
Slide 21: XACIATO Use in Special Populations
XACIATO Use in Special Populations* . * Other clindamycin vaginal products have been used to treat pregnant women during the second and Special third trimester. XACIATO has not been studied in pregnant women. However, based on the low Populations systemic absorption of XACIATO following the intravag
Slide 22: U.S. Commercialization Collaborator / Phase 3 Development Collaborator
U.S. Commercialization Collaborator: (49 Phase 3 Development Collaborator:
Slide 23: Contraception: Large Market Opportunity
Contraception: Large Market Opportunity Women in the Reproductive Health & Successful Contraceptive Brands Peak Sales: Contraception Market Segment (over 60 million women) Total us Femates Age 15-44 (millons) Source: US Census Bureau, 2027 National Dataset (2026 is base population estimate for proje
Slide 24: Ovaprene® - Potential Market Opportunity
Ovaprene® - Potential Market Opportunity There are approximately 65 million women in the US Aged 15-44? 30 Million Women? Not candidates for Ovaprene® @eceeeeeeeeen Currently use Pill (10.3M) *Sterilization (10.5M) no sinjectable (1.5M) *Pregnant/postpartum/ seeking contraception *Vaginal Ring pregn
Slide 25: Pregnancies Expected: Hormone-free Options
Pregnancies Expected Hormone-free Options ae (per 100 women) * Least Effective Spermicides >27 & Vaginal Gels? Condoms (male) 18 Diaphragms (with a spermicide) al) Easy-to-use monthly Effectiveness approaching option hormonal methods Copper IUD <1 Most Effective U.S. Food and Drug Administration Bir
Slide 26: Ovaprene® Investigational Hormone-Free, Monthly Contraceptive
Ovaprene® Investigational Hormone-Free, Monthly Contraceptive Desired Features of Physical Barrier © Birth Control Products: « Design Features of Ovaprene:>” Three-dimensional, . knitted polymer barrier +Efficacy 86% - 91% Expected Typical Use Effectiveness Approaching User-Controlled Hormone Contra
Slide 27: Ovaprene® - Commercial License Agreement with Bayer
Ovaprene® - Commercial License Agreement with Bayer* January 2020 - Bayer, which markets the ( oaayee received the right to obtain exclusive US rights to $1 billion Mirena contraceptive franchise, commercialize the product, following completion of the and Daré announced the execution of a pivotal cl
Slide 28: Ovaprene® - Collaborative Research Agreement with NIH
Ovaprene® - Collaborative Research Agreement with NIH* July 2024 — Dare announced that funding and (... pivotal Phase 3 study will be supported by the NICHD’s clinical operations support for the Phase 3 will be provided by the National Institutes of Health’s Eunice Kennedy Shriver National Institute
Slide 29: Ovaprene® - U.S. Regulatory Strategy
2.Mauck C., Vincent K. Biology of Reproduction, Volume Ovaprene® - U.S. Regulatory Strategy* Premarket approval (PMA) strategy — The Center for Devices and Radiological Health (CDRH) as lead review division Step 1 (Completed) Postcoital Test (PCT) Clinical Study - Completed 40 2019 Step 2 (Ongoing)
Slide 30: Potential First-In-Category treatment for Female Sexual Arousal Disorder
Potential First-In-Category treatment for Female Sexual Arousal Disorder (FSAD), which has no FDA-approved therapies Novel cream formulation of sildenafil to treat FSAD, utilizing active ingredient in Viagra® 30
Slide 31: FSAD - The Clinical Issue
FSAD - The Clinical Issue Female Sexual Arousal Disorder (FSAD) is characterized The condition should be distinguished primarily by inability to attain or maintain sufficient genital from a general loss of interest in sexual arousal during sexual activity and, of female sexual function activity and
Slide 32: FSAD — What is the incidence?
FSAD — What is the incidence? a Y Meta-analysis of 95 studies from 2000-2014 indicated prevalence of Female Sexual Dysfunction in premenopausal women worldwide is 41%, and difficulty with arousal alone is 23%.* y \ Market research estimates: > 33% of US women aged 21 to 60 (~ 20 million women), expe
Slide 33: Sildenafil Cream, 3.6% - Product Profile
Sildenafil Cream, 3.6% - Product Profile Topically administered investigational Sildenafil Cream? is... >A PDEs inhibitor utilized in ED medications for men — ED product Viagra® peaked at $2.05 billion in sales in 2012.? > Designed to increase local blood flow to provide improvement in genital arous
Slide 34: Sildenafil Cream, 3.6% - Phase 2b
Sildenafil Cream, 3.6% - Phase 2b Ongoing Phase 2b clinical study aims to evaluate Sildenafil Cream vs. placebo over 12 weeks of dosing following both a non-drug and placebo run-in period. > Compares Sildenafil Cream vs. placebo used in patients’ home setting. »> Primary endpoint: patient reported o
Slide 35: Oral Sildenafil provided a compelling proof of concept for FSAD
Oral Sildenafil provided a compelling proof of concept for FSAD Statistically significant increases in Vaginal Pulse Statistically significant improvement in genital ; ; + Question #2 - “After taking study medication, the Amplitude (VPA)* stimulation (FIEI)* sensation/feeling in my genital (vaginal,
Slide 36: Sildenafil Cream, 3.6% - Phase 1 and Phase 2a Study Results
Sildenafil Cream, 3.6% - Phase 1 and Phase 2a Study Results Phase 1 Study of SST-6007 (Sildenafil Cream, 3.6%)? 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 exposure
Slide 37: Sildenafil Cream, 3.6% - Thermography Study Results
Sildenafil Cream, 3.6% - Thermography Study Results* Demonstrated time to effect (See Figure 2) Figure 1. Clitoral temperature change during the sexually explicit film Positive cognitive arousal responses sildenafil Cream were noted. 25 Significantly greater increases in genital Placebo Cream temper
Slide 38: Phase 1 and Preclinical Programs
Phase 1 and Preclinical Programs New investigational prescription drug delivery options for women
Slide 39: Advancing Products Women Want - Phase 1 and Preclinical
Advancing Products Women Want - Phase 1 and Preclinical Hormone Therapy - Phase 1 Completed; Pregnancy Maintenance Vulvar and Vaginal Atrophy Phase 1/2 Study Completed Phase a Study Preparation Phase 1/2 Study Commenced 1. First-in-category combination hormone delivery for 1. First-in-category proge
Slide 40: Intravaginal Ring (IVR) Technology Highlights
Intravaginal Ring (IVR) Technology Highlights The Vaginal Route of Drug Administration? Our IVR Technology — Design Features: > Vaginal drug delivery offers many > Sustained drug delivery, potential advantages due to large surface area, dense network of blood vessels and high elasticity due to } Sol
Slide 41: DARE-HRT1
DARE-HRT1* Combination bio-identical estradiol + bio-identical progesterone 28-day IVR for hormone therapy following menopause. There are no FDA approved options with both hormones in one monthly IVR. Over 45M women in U.S. approaching or in menopause* a > Hormone Therapy (HT) HT remains the most ef
Slide 42: DARE-HRT1
DARE-HRT1* Completed Phase 1 STUDY A Phase 1, Open-Label, 3-arm Parallel Group Study to Evaluate the Pharmacokinetics (PK) and Safety of DARE-HRT1 (80 yg and 160 yg Estradiol/ 4 mg and 8 mg Progesterone Intravaginal Rings) in Healthy Post-Menopausal Women. The topline data from the study support DAR
Slide 43: DARE-FRT1 and DARE-PTB1
DARE-FRT1 and DARE-PTBa* Bio-identical progesterone 14-day IVR for prevention of preterm birth and luteal phase support as part of an IVF treatment plan. There are currently no FDA approved products marketed in the U.S. that do not require daily dosing of progesterone. {) +*505(b)(2) candidate* Prev
Slide 44: DARE-VVA1
DARE-VVA1* Proprietary tamoxifen formulation for vaginal administration for vulvar and vaginal atrophy (VVA), a chronic condition characterized by pain during intercourse, vaginal dryness and irritation. There are currently no FDA approved products labeled for VVA treatment in HR+ breast cancer. Pot
Slide 45: DARE-VVA1 - Proof of Concept
DARE-VVAsz - Proof of Concept This exploratory study? in four postmenopausal women diagnosed with VVA demonstrated that a self-administered vaginal suppository containing tamoxifen (20mg) dosed daily for one week and twice weekly for three months was effective in reducing vaginal pH and vaginal dryn
Slide 46: DARE-VVA1 - Phase 1/2 Study
DARE-VVAz - Phase 1/2 Study Phase 1/2 study’ is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of DARE-VVA1 in postmenopausal participants with moderate to severe VVA and is being conducted by the Company’s wholly owned subsidiary in Australia. * The Phase 1/2 study will eval
Slide 47: ADARE 204/214
ADARE 204/214* Novel 6 & 12-month injectable formulations of etonogestrel being developed as a longer-acting, reversible method of contraception with a more predictable return to fertility. There are currently no FDA approved injectable contraceptives available indicated for 6-12 months protection.
Slide 48: DARE-LARC1
DARE-LARC1* Long-Acting, Reversible Personal Contraceptive System — levonorgestrel-releasing implant drug delivery system designed to store and precisely deliver hundreds of therapeutic doses over years that a woman can turn on and off herself, according to her own needs, without further healthcare
Slide 49: DARE-GML
DARE-GML Glycerol monolaurate (GML) is a naturally occurring fatty acid monoester that has shown broad antimicrobial activity, killing bacteria, fungi and viruses, and represents a new class of antimicrobial agents. GML has the potential to be a first-in-category multi-target antimicrobial. Bacteria
Slide 50: Daring to Be Different and Advancing Products Women Want
NASDAQ: DARE www.darebioscience.com “) DARING TO BE DIFFERENT® AND ADVANCING daré PRODUCTS WOMEN WANT 50