Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (December 2021)
46 slides from Dare Bioscience's investor presentation, Dec 8, 2021
Slide 1: Corporate Presentation: December 8, 2021
Daré Bioscience DARÉ IN ITALIAN, IT MEANS “TO GIVE.” IN ENGLISH, IT MEANS “TO BE BOLD.” NASDAQ: DARE www.darebioscience.com Corporate Presentation: December 8, 2021 ©2021 Daré Bioscience | All rights reserved Exhibit 99.1
Slide 2: Forward-Looking Statements; Disclaimers
Forward-Looking Statements; Disclaimers 2 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 st
Slide 3: Women's Health is Our Sole Focus
3 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 wom
Slide 4: Daré Bioscience: A Compelling Opportunity
1 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
Slide 5: Advancing Products Women Want – The Portfolio Snapshot
DARE-HRT1^ Hormone Therapy Phase 1 Study Topline Data Announced June 2021 DARE-FRT1^ Pregnancy Maintenance Phase 1 Study Preparation DARE-VVA1^ Vulvar and Vaginal Atrophy Phase 1 /2 Study Commenced 2021 DARE-LARC1^ Long-Acting, Reversible Personal Contraceptive System ADARE 204/214^ 6 & 12-Month Inj
Slide 6: Product candidates and partners
6 PARTNERS Product Candidate PRE- CLINICAL PHASE 1 PHASE 2 PHASE 3 / PIVOTAL REGULATORY FILING FDA approved XACIATOTM (clindamycin phosphate) vaginal gel, 2% Bacterial Vaginosis NDA approved Dec. 7, 2021 XACIATO is indicated for the treatment of bacterial vaginosis in females 12 years or older. See
Slide 7: Phase 1 and preclinical product candidates
DARE-HRT1^ Hormone Therapy - Phase 1 Study Completed DARE-FRT1^ Pregnancy Maintenance - Phase 1 Study Preparation DARE-VVA1^ Vulvar and Vaginal Atrophy – Phase 1/2 Study Commenced DARE-LARC1^ Long-Acting, Reversible Personal Contraceptive System ADARE 204/214^ 6 & 12-Month Injectable Contraception ^
Slide 8: Near Term Catalysts to Drive Value
8 Near Term Catalysts to Drive Value XACIATO 1. NDA approved December 7, 2021 2. Partnering discussions ongoing to support 2022 launch DARE-VVA1 1. Phase 1/2 commenced 3Q2021 2. Topline Phase 1/2 data anticipated 2022 Ovaprene 1. IDE submission planned for 4Q2021 2. Pivotal study commence anticipate
Slide 9: Women's health pipeline with milestones anticipated in 2022
9 Innovative women’s health pipeline with multiple clinical, regulatory and commercial milestones anticipated in 2022. Every program, if approved, represents a potential first-line or first-in-class product opportunity. Experienced Board of Directors and Management Team with demonstrated success in
Slide 10: Experienced Management & Board of Directors
10 Experienced Management & Board of Directors Sabrina Martucci Johnson MSc, MIM President & CEO John Fair Chief Strategy Officer Lisa Walters-Hoffert Chief Financial Officer David Friend, PhD Chief Scientific Officer Mary Jarosz, RPh, RAC, FTOPRA Global Head of Regulatory Affairs Mark Walters Vice
Slide 11: XACIATO (DARE-BV1) Clindamycin 2% gel for Bacterial Vaginosis
11 DARE- BV1 Clindamycin 2% gel for Bacterial Vaginosis XACIATOTM (Clindamycin Phosphate) Vaginal Gel, 2% FDA approved for the treatment of bacterial vaginosis, the most common vaginal infection in women of reproductive age Convenient, one-time intravaginal administration NDA approved December 7, 20
Slide 12: Bacterial Vaginosis increases health risk
12 1.https://www.cdc.gov/std/bv/stats.htm 2.Bacterial vaginosis product data: http://www.clindesse.com/pdf/PI.pdf; http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205223s000lbl.pdf; http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205223s000lbl.pdf 3.https://www.mayoclinic.org/disea
Slide 13: XACIATO: Overview
13 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. ➤ Prescribing information supports positioning of XACIATO as a first line option for
Slide 14: XACIATO – A Difference in the Lives of Women
14 XACIATO – A Difference in the Lives of Women “The FDA approval of XACIATO marks a major milestone not only for Daré as a company but, importantly, for the 21 million women impacted by bacterial vaginosis,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “It is our goal as a c
Slide 15: Important Safety Information
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 and Administration: Administer one applicatorful (5 g of gel containing 100 mg
Slide 16: XACIATO: Use in Specific Populations
Use in Specific Populations*: • Other clindamycin vaginal products have been used to treat pregnant women during the second and third trimester. XACIATO has not been studied in pregnant women. However, based on the low systemic absorption of XACIATO following the intravaginal route of administration
Slide 17: Ovaprene
17 Ovaprene® Investigational potential first-in-category, hormone-free, monthly birth control Partnered With
Slide 18: Ovaprene - Commercial License Agreement with Bayer
18 Ovaprene® - Commercial License Agreement with Bayer1 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 investigational contraceptive in the US once approved by FDA
Slide 19: Contraception: Large Market Opportunity
19 Contraception: Large Market Opportunity Women in the Reproductive Health & Contraception Market Segment (over 60 million women) Mirena® Hormone IUD (levonorgestrel-releasing intrauterine system) 52mg Physician inserted, long-acting. low/locally delivered hormone IUS 2019 worldwide sales: €1.2 bil
Slide 20: Ovaprene - Potential Market Opportunity
20 Ovaprene® - Potential Market Opportunity There are approximately 65 million women in the US Aged 15-441 12 Million Current Non-Users 11 Million Current Hormone-free Product Users 12 Million Current Hormonal Product Users 35 Million Women2,3 Potential Candidates for Ovaprene® •Pill (10.3M) •Inject
Slide 21: Contraception: What's Missing from Current Hormone-Free Options?
21 Contraception: What’s Missing from Current Hormone-Free Options? Hormone-free Options Pregnancies Expected (per 100 women) 1,* Spermicides & Vaginal Gels 2 Condoms (male) Diaphragms (with a spermicide) Easy-to-use monthly option Copper IUD >27 18 12 Effectiveness approaching hormonal methods <1 L
Slide 22: Ovaprene Investigational Hormone-Free, Monthly Contraceptive
22 Ovaprene® Investigational Hormone-Free, Monthly Contraceptive Spermiostatic Environment6 Contraceptive-loaded silicone ring releasing non-hormonal active Ferrous gluconate Physical Barrier 6 Three-dimensional, knitted polymer barrier 1.https://www.urban.org/urban-wire/women-want-effective-birth-c
Slide 23: Ovaprene - U.S. Regulatory Strategy
23 Ovaprene® - U.S. Regulatory Strategy1 Step 1 (Completed) •Postcoital Test (PCT) Clinical Study - Completed 4Q 2019 Step 2 (Ongoing) 1 - File investigational device exemption (IDE) 4Q2021 to support 2022 pivotal study start. 2 - Conduct pivotal study • ~250 completers up to 12 months of use • Prim
Slide 24: Ovaprene - Collaborative Research Agreement with NIH
24 Ovaprene® - Collaborative Research Agreement with NIH1 July 2021 – Daré announced that funding and clinical operations support for the Phase 3 will be provided by the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Under the
Slide 25: Sildenafil Cream, 3.6%
25 Sildenafil Cream, 3.6% 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®
Slide 26: FSAD – The Clinical Issue
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.* The condition should be distinguished from a general
Slide 27: FSAD – What is the incidence?
27 FSAD – What is the incidence? 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%.1 Market research estimates: ➤33% of US women aged 21 to 60 (~ 20 million women), experience
Slide 28: Sildenafil Cream, 3.6% - Product Profile
28 Sildenafil Cream, 3.6% - Product Profile ➤A PDE5 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. ➤Applied topically, avoiding hepatic first-pass
Slide 29: Sildenafil Cream, 3.6% - Phase 2b
29 Sildenafil Cream, 3.6% - Phase 2b ➤Compares Sildenafil Cream vs. placebo used in patients’ home setting. ➤Primary endpoint: patient reported outcome (PRO) instruments to measure improvement in localized genital sensations of arousal and reduction in FSAD related distress. ➤Several exploratory eff
Slide 30: Oral Sildenafil provided a compelling proof of concept for FSAD
30 Oral Sildenafil provided a compelling proof of concept for FSAD † Question #2 – “After taking study medication, the sensation/feeling in my genital (vaginal, labia, clitoris) area during intercourse or stimulation (foreplay) seemed to be: (a) more than before, (b) less than before, or (c) unchang
Slide 31: Sildenafil Cream - Phase 1 and Phase 2a Study Results
31 Phase 1 Study Phase 1 Study of SST-6007 (Sildenafil Cream, 3.6%)1 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 compared to a 50 mg oral sildenafil dose •
Slide 32: Sildenafil Cream, 3.6% - Thermography Study Results
32 Sildenafil Cream, 3.6% - Thermography Study Results Demonstrated time to effect (See Figure 1) •Positive cognitive arousal responses were noted. •Significantly greater increases in genital temperature after application of Sildenafil Cream compared to placebo cream. •Significantly greater self-rep
Slide 33: Milestones and Catalysts
Milestones and Catalysts 33
Slide 34: Daré – Working to Accelerate Innovation in Women's Health
34 Daré – Working to Accelerate Innovation in Women’s Health 2019 and 2020 Positive findings of Sildenafil Cream, 3.6% thermography clinical study Positive topline data for Ovaprene® postcoital test clinical study Exclusive licensing agreement with Bayer for Ovaprene Strategic partnerships w
Slide 35: Phase 1 and Preclinical Programs
35 Phase 1 and Preclinical Programs New investigational prescription drug delivery options for women 35
Slide 36: Phase 1 and Preclinical Product Candidates
DARE-HRT1^ Hormone Therapy - Phase 1 Study Completed DARE-FRT1^ Pregnancy Maintenance - Phase 1 Study Preparation DARE-VVA1^ Vulvar and Vaginal Atrophy – Phase 1/2 Study Commenced DARE-LARC1^ Long-Acting, Reversible Personal Contraceptive System ADARE 204/214^ 6 & 12-Month Injectable Contraception ^
Slide 37: Intravaginal Ring (IVR) Technology Highlights
37 Intravaginal Ring (IVR) Technology Highlights ➤Vaginal drug delivery offers many potential advantages due to large surface area, dense network of blood vessels and high elasticity due to presence of smooth muscle fibers. ➤Recognized advantages include comparable ease of administration and ability
Slide 38: DARE-HRT1
38 DARE-HRT1 Combination bio-identical estradiol + bio-identical progesterone 28-day IVR for hormone therapy following menopause 45M women in U.S. approaching or in menopause1 Hormone Therapy (HT) HT remains the most effective treatment for vasomotor symptoms (VMS) and genitourinary syndrome of meno
Slide 39: DARE-FRT1
39 DARE-FRT1 Bio-identical progesterone 14-day IVR for prevention of preterm birth and luteal phase support as part of an IVF treatment plan Prevention of Preterm Birth (PTB) After steadily declining from 2007 to 20142, the US premature birth rate rose for the fourth straight year in 2018 with ~10%
Slide 40: DARE-VVA1
40 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 Potential to be the first therapeutic specifically approved for treatment of VVA in patients wi
Slide 41: DARE-VVA1 - Proof of Concept
41 Vaginal Tamoxifen Enrollment (Baseline) On Treatment (Month 3) Paired Difference (Baseline vs. Month 3) Median Vaginal pH Normal vaginal pH is usually less than 4.5.2 7.1 range 6.5 to 7.5 5.0 range 5.0 to 5.2 -2.0 median range -2.5 to -1.5 Lower pH value is a measure of symptom relief Vaginal Dry
Slide 42: DARE-VVA1 – Phase 1/2 Study
42 DARE-VVA1 – Phase 1/2 Study Phase 1/2 study1 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 e
Slide 43: DARE-LARC1
43 DARE-LARC1 Through June 2021 June 2021 – Nov. 2026 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
Slide 44: Financial Summary
44 Financial Summary
Slide 45: Daré Financial Summary Sept. 30, 2021
45 Funding sources: •Since inception, we have raised cash through sale of equity securities, M&A transactions, warrant and option exercises, non- dilutive grants, and license fees •We endeavor to be creative and opportunistic in seeking capital required to advance our candidates, and to be efficient
Slide 46: Daring to Be Different and Advancing Products Women Want
46 DARING TO BE DIFFERENT® AND ADVANCING PRODUCTS WOMEN WANT NASDAQ: DARE www.darebioscience.com DARE TO BE BOLD
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