Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (February 2023)
54 slides from Dare Bioscience's investor presentation, Feb 6, 2023
Slide 1: Corporate Presentation: February 6, 2023
; 7 : Exhibit 99.1 0) Dare Bioscience = DARE IN ITALIAN, IT MEANS “TO GIVE.” IN ENGLISH, IT MEANS “TO BE BOLD.” NASDAQ: DARE Corporate Presentation: February 6, 2023 ©2023 Daré Bioscience | All rights reserved www.darebioscience.com
Slide 2: Forward-Looking Statements; Disclaimers
HH MEETEE TEEPE] 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
Slide 3: Women's Health is Our Sole Focus
Women’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, vaginal, and reproductive, menopause, and sexual
Slide 4: Women's Health — An Efficient Investment Thesis
Women'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 p
Slide 5: Compelling Markets Where Innovation Matters
Women’s Heal Contraception ~73 million women ages 15-49 as hormonal monthly IVR, NuvaRing, ~$900M at peak? ast hormonal |UD, Mirena franchise, ~$2.2B at peak? a5" copper IUD, still ~$200M/yr 40 years post launch* Reproductive, Menopause, and Sexual Health - 47 million new entrants to menopause and p
Slide 6: Daré Portfolio — The Big Ideas
Daré Portfolio — The Big Ideas* Contraception Ovaprene ® -1* Hormone-free, Monthly Contraceptive ADARE-204/224 - 4 6 & 12-Month Injectable Contraceptive DARE-LARCa - a* Long-Acting, Reversible Personal Contraceptive System (grant funded program) DARE-RHa - Hormone-free contraceptive target for women
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 Diverse pipeline with independent outcomes One FDA-approved product and several clinical development stage candidates utilizing
Slide 8: Advancing Products Women Want - The Portfolio Snapshot
Advancing Products Women Want - The Portfolio Snapshot PHASE 3/ REGULATORY FDA PIVOTAL, SUBMISSION APPROVED ‘ — DD sacsses sti Female Sena roa Disorder ‘Phaze ab Study Completed Screening Octabers022 daré' PRE-CLINICAL PHASE. PHASE2 * Portfolio of numerous first-line and first-in-category product ca
Slide 9: FDA Approved — XACIATO
FDA Approved — XACIATO XACIATO™ (Clindamycin Phosphate) Vaginal Gel, 2% NDA approved December 7, 2023 QIDP, Fast Track and Priority Review Designations Commercialization Collaborator “fF ORGANON + XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicat
Slide 10: Advancing Products Women Want - Late Stage Programs
Advancing Products Women Want - Late Stage Programs Ovaprene” Hormone-Free, Monthly Contraception ) vin) jeer al ice mimi ree contraception Pivotal Phase 3 Study to Commence 2023* ante 2 Self-administered intravaginal ‘+ Investigational hormone free, monthly intravaginal contraceptive. drugidevice *
Slide 11: Advancing Products Women Want - Phase and Preclinical
Advancing Products Women Want - Phase 1 and Preclinical Pregnancy Maintenance Phase 2 Study Preparation Firstin-category progesterone delvary for pregnancy maintenance including the prevention of preterm birth (OARE-PTB3) {and for lteal phase support as pat of an IVF regimen (DARE-FRT2), IVR designe
Slide 12: Daré: Advancing Products Women Want
Daré: Advancing Products Women Want Innovative women's Every program, if Experienced Board of Directors Womens health health pipeline with | _~_approved, represents and Management Team with veddne rere multiple upcoming a potential first-line or - demonstrated success in clinical 9g ig mn i ; and pr
Slide 13: Experienced Management & Board of Directors
Experienced Management & Board of Directors Management Team Board of Directors Wiliam Rastettr, PhD a Greg Matz, PA Gomes Sabrina Martucci Johnson, MSc, MIM President & CEO John Fair Chief Strategy Officer Cheryl Blanchard, PhD Sophia N. Ononye-Onyia, PhD, MPH, MBA Walters-Hoffert Jessica Grossman,
Slide 14: Daré Financial Highlights
Daré Financial Highlights 30-2022 Snapshot: + Cash and equivalents 9/30/22: $40.4 M + Common shares o/s (11/9/22): 84.8 M + Warrants o/s: 1.4 M Funding sources: Non-dilutive Cash received: 30-2022 : ~s18.0M + Upfront license fee from Organon $10.0 M + Existing grant for DARE-LARCa: ~$8.0 M October 2
Slide 15: Upcoming Program Milestones
Dar to Accelerate Innovation in Women Ovaprene® (hormone-free monthly contraception) . + Pivotal Phase 3 study recruitment initiation mid-2023 Upcoming Program Milestones*: XACIATO™ (clindamycin phosphate) vaginal gel, 2% + First commercial sale in 2H 2023 in the U.S. Sildenafil Cream, 3.6% (female
Slide 16: Commercialization Collaborator
Commercialization Collaborator:
Slide 17: Bacterial Vaginosis
cterial Vaginosis Recurring infection, difficult to treat effectively ) + Most common vaginal condition in women ages 15-44 Clinical t + Affects ~21 million women in the US* Ileal yssve: + Bacterial Vaginosis increases health risks*, including increased risk of preterm birth, sexually transmitted in
Slide 18: XACIATO Overview
XACIA 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. ra > This marks the first FDA-approved product in Daré’s portfolio of potential QIDP, Fas
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 $20 million upfront payment from Organon became e
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 200 mg of clindamy
Slide 21: XACIATO Use in Special Populations
XACIATO Use in Special Populations* ‘5 + 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 intrava
Slide 22: U.S. Commercialization Collaborator
U.S. Commercialization Collaborator: Phase 3 Development Collaborator:
Slide 23: Contraception: Large Market Opportunity
Contraception: Large Market Opportunity Successful Contraceptive Brands Peak Sales: Women in the Reproductive Health & Contraception Market Segment (over 60 million women) . totem Age 1-44 ten) Source: US Census Bureau, 20:7 National Dataset (2036 is base population estimate for projection) hteps:iw
Slide 24: Ovaprene - Potential Market Opportunity
Ovaprene® - Potential Market Opportunity There are approximately 65 million women in the US Aged 15-442 35 Million Women?3 30 Million Women?3 Potential Candidates Not candidates for for Ovaprene® Ovaprene® 2 Million 22 Million Current > Covan: Atal Hormonal Product Users y 22 Million . *Currently us
Slide 25: Current Hormone-Free Options
trent Hormone-Free Options? Hormone-free Options Pregnancies Expected (per 100 women) ** Least Effective Spermicides = & Vaginal Gels? Condoms (male) 18 Diaphragms (with a spermicide) + Copper IUD. <a Most Effective 25
Slide 26: Ovaprene Investigational Hormone-Free, Monthly Contraceptive
Ovaprene® Investigational Hormone-Free, Monthly Contraceptive Physical Barrier® Three-dimensional, knitted polymer barrier Spermiostatic Environment® Desired Features of Birth Control Products" + Efficacy «Hormone Free «Convenience + Favorable Side Contraceptive-loaded silicone ring Effect Profile r
Slide 27: Ovaprene - Commercial License Agreement with Bayer
Ovaprene® - Commercial License Agreement with Bayer* January 2020 - Bayer, which markets the / Bayer 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 c
Slide 28: Ovaprene - Collaborative Research Agreement with NIH
Ovaprene?® - Collaborative Research Agreement with NIH* July 2021 Daré announced that funding and |, the pivotal Phase 3 study will be supported by the NICHD's Contraceptive Development Program which oversees the Contraceptive will be provided hy the National Institutes of Clinical Trial Network (CC
Slide 29: 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 Step a (Completed) +Postcoital Test (PCT) Clinical Study - Completed 40 2019 Step 2 (Ongoing) 1- FDA approval of investigational device exemption (I
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: Female Sexual Arousal Disorder (FSAD)
eCcl Female Sexual Arousal Disorder (FSAD) is characterized primarily by inability to attain or maintain sufficient genital arousal during sexual activity and, of female sexual function disorders, is most analogous to erectile dysfunction (ED) in men.* FSAD + HSDD. ical Issue The condition should be
Slide 32: FSAD — What is the incidence?
FSAD — What is the incidenc A \ 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%.* X AJ ‘a \ jarket research estimates: > 33% of US women aged 21 to 60 (~ 20 million women),
Slide 33: Sildenafil Cream, 3.6% - Product Profile
Sildenafil Cream, ct 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 2012.2 » Designed to increase local blood flow to provide improvement in genital arousal response. >
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 ou
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 Amplitude (VPA)? stimulation (FIE!)* ‘sensationifeeling in my genital (vaginal, labia, clitoris) area Pfizer VPA Clinical Lab Study -
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 2 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 3) Figure 1, Clitoral temperature change during the sexually explicit film *Positive cognitive arousal responses sidenafi ream were noted. oy Statistically significant greater Significantly greater increases
Slide 38: Potential First-In-Category 28-day intravaginal ring
Potential First-In-Category 28-day intravaginal ring combination bio-identical estradiol and bio-identical progesterone for hormone therapy for treatment of vasomotor symptoms due to menopause. There are no FDA approved options with both hormones in one monthly IVR. 38
Slide 39: 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 } So
Slide 40: DARE-HRT1
DARE-HR 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* Hormone Therapy (HT) HT remains the most effective
Slide 41: DARE-HRT1 Completed Phase 1/2 Study
DARE-HRT2 Completed Phase 1 STUDY ‘Phase 1, Open-Label, 3-arm Parallel Group Study to Evaluate the Pharmacokinetics (PK) and Safety of DARE-HRT2 (80 j1g and 160 ig Estrat and 8 mg Progesterone Intravaginal Rings) in Healthy Post-Menopausal Women. Vang The topline data from the study support DARE-HRT
Slide 42: DARE-HRT1 - U.S. Regulatory Strategy
DARE-HRT31 - U.S. Regulatory Strategy* Following clinical development, Daré intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol and progesterone, to utilize the U.S. Food and Drug Administration's (FDA) 505(b)(2) pathway to obtain marketing app
Slide 43: Phase 1 and Preclinical Programs
Phase 1 and Preclinical Programs New investigational prescription drug delivery options for women
Slide 44: Advancing Products Women Want - Phase 1 and Preclinical
Advancing Products Women Want - Phase 1 and Preclinical Pregnancy Maintenance Phase 2 Study Preparation Firstin-category progesterone delvary for pregnancy maintenance including the prevention of preterm birth (OARE-PTB3) {and for lteal phase support as pat of an IVF regimen (DARE-FRT2), IVR designe
Slide 45: 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. NH *sostba} candidate Preventi
Slide 46: DARE-VVA1
ARE-VVA2 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. Poten
Slide 47: DARE-VVA1 - Proof of Concept
DARE-VVAz - Proof of Concept This exploratory study* in four postmenopausal women diagnosed with VVA demonstrated that a self-administered vaginal suppository containing tamoxifen (2omg) dosed daily for one week and twice weekly for three months was effective in reducing vaginal pH and vaginal dryne
Slide 48: DARE-VVA1 Phase 1/2 Study
DARE-VVAz Phase 1/2 Study* Completed Phase 1/2 STUDY The Phase 2/2 study evaluated different doses of DARE-VVAa, a tamoxifen vaginal insert, in 27 post menopausal women with WA. The study was a randomized, multi-center, double-blind, parallel-arm, placebo-controlled, dose-ranging study that evaluate
Slide 49: DARE-PDM1
ARE-PDM1 Proprietary hydrogel formulation of diclofenac for vaginal administration. Alternative to oral nonsteroidal anti-inflammatory drugs (NSAIDs) and hormonal contraceptives, which often can produce undesirable side effects. There are currently no FDA-approved vaginal diclofenac treatment option
Slide 50: DARE 204/214
ARE 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. ~6
Slide 51: 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 52: 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 53: DARE-LBT
ARE Novel hydrogel formulation for delivery of live biotherapeutics to support vaginal health There are currently no FDA approved live biotherapeutics for vaginal health. Grant from the Bill & Melinda Gates Foundation for $584,986 to support acti s related to development of a vaginal thermosetting g
Slide 54: www.darebioscience.com
NASDAQ: DARE www-darebioscience.com (0) DARING TO BE DIFFERENT® AND ADVANCING daré PRODUCTS WOMEN WANT 54
Dare Bioscience — Investor Presentation (February 2023) on 6ix