Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (June 2018)
38 slides from Dare Bioscience's investor presentation, Jun 15, 2018
Slide 1: Delivering innovation by daring to be different
Delivering innovation by daring to be different June 15, 2018 Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements 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 SERVI
Slide 3: Mission & Vision
Mission & Vision To become the coordinating presence in women’s health by identifying and unlocking innovation that addresses unmet need. To develop and optimize a portfolio of novel therapies that improve health outcomes and promote a better quality of life for women.
Slide 4: Daré Highlights
Daré Highlights Daring to be different A pure play biopharmaceutical company squarely focused on improving the health and well being of women. Focused on targeted delivery of products to address persistent unmet needs in women’s health: Pregnancy Prevention Sexual Health Vaginal Health Fertility The
Slide 5: Coordinating Innovation in Women's Health
Coordinating Innovation in Women’s Health Daré is building a strong and strategic network to advance innovation in women’s health. Global Women's Health Market Worth $51 Billion by 2025 - CAGR: 3.9% 1 1. https://www.prnewswire.com/news-releases/womens-health-market-size-worth-513-billion-by-2025--ca
Slide 6: Portfolio Timeline Overview
Portfolio Timeline Overview Timeline reflects management’s current estimates and constitutes a forward looking statement subject to qualifications elsewhere in the presentation. Actual development timeline may be substantially longer, and Daré is under no obligation to update or review this estimate
Slide 7: Contraception $32 billion global category
1. Global Market Insights, https://globenewswire.com/news-release/2016/05/19/841462/0/en/Contraceptives-Market-size-to-exceed-33-Billion-by-2023-Global-Market-Insights-Inc.html Contraception $32 billion global category1
Slide 8: What's Driving Innovation in Contraception
What’s Driving Innovation in Contraception 5. 2017 SEC Financial Filings Innovation in Contraception Advances in hormone products have largely focused on reducing the hormone dosage, adjusting or extending the duration of protection and optimizing methods of administration. Convenience is driving ne
Slide 9: U.S. Contraceptive Market
U.S. Contraceptive Market IMS NSP through Dec 2016; : IRI 2013 Ersek, J, Matern Child Health J (2011) 15:497–506 www.guttmacher.org, contraceptive fact sheet Large Market Opportunity >$6 billion in US Rx sales of contraceptive products (2016).1 40 million women of reproductive age currently using a
Slide 10: Non-hormonal Products (marketed or in development)
Non-hormonal Products (marketed or in development) Spermicides / vaginal gels Least effective woman controlled On-demand / pre-coital application Condoms Effective, not woman controlled On-demand / pre-coital application Diaphragms Most effective woman controlled On-demand / pre-coital insertion Lon
Slide 11: What Women Want from Birth Control
What Women Want from Birth Control Women’s Preferences: Effective Pregnancy Prevention Convenient Product Forms 67% of women report that the vaginal ring has most of the features deemed extremely important.1 Less Hormones 85% of women would prefer a monthly option with a lower hormone dose than the
Slide 12: Ovaprene: A New Contraceptive Opportunity
Ovaprene® A New Contraceptive Opportunity Monthly Non-Hormonal Opportunity
Slide 13: Ovaprene Non-hormonal Vaginal Ring
Ovaprene Non-hormonal Vaginal Ring1 Monthly, Hormone Free – Contraception Silicone ring Fluid-permeable mesh barrier Spermiostatic Environment Achieved through a contraceptive-loaded silicone matrix releasing non-hormonal active: Ferrous gluconate Monthly intravaginal ring 1-Month ring convenience R
Slide 14: Ovaprene Human Proof of Concept Study
Ovaprene Human Proof of Concept Study 2009 - Postcoital Assessment:1 Open-label, single-arm, pilot safety and tolerability study. Published in the Journal of Reproductive Medicine, 2009. Patients: N= 21; all women completed one cycle of use. Results: Postcoital testing revealed no viable sperm in th
Slide 15: Ovaprene Regulatory Strategy
Ovaprene Regulatory Strategy Step 1 – 2018 / 2019 - Postcoital test (PCT) The study is enrolling 50 couples, with the woman to be evaluated over the course of five menstrual cycles, with a target of having 25 women complete a total of 21 visits. Each woman’s cervical mucus will be measured at severa
Slide 16: Ovaprene Valuation Drivers (Potential)
Ovaprene™ Valuation Drivers (Potential) J.L. Schwartz et al. / Contraception 78 (2008) 237–244. Schwartz JL, Weiner DH, Lai JJ, et al. Contraceptive efficacy, safety, fit, and acceptability of SILCS, a novel single-size diaphragm. 2014. 2020 – 2H2021 2018 – 2H2019 PCT Clinical Trial Ex: Caya® trial
Slide 17: Ovaprene Summary
Ovaprene Summary What Women Want from Birth Control https://www.urban.org/urban-wire/women-want-effective-birth-control Lessard, L,Perspectives on Sexual and Reproductive Health, Volume 44, Number 3,9-2012 Hooper, DJ, Clin Drug Investig. 2010;30(11):74963 Ersek, J, Matern Child Health J (2011) 15:4
Slide 18: Women's Sexual Health & Wellness: FSAD
8 1. https://www.visiongain.com/Press_Release/911/Sexual-dysfunction-drugs-market-will-reach-7-7bn-in-2019 Female Sexual Arousal Disorder (FSAD) World market for both male and female sexual dysfunction drugs will reach 7.7 billion in 20191 Women’s Sexual Health & Wellness
Slide 19: Female Sexual Dysfunction Market Landscape
Vulvar-Vaginal Atrophy Female Sexual Arousal Disorder (FSAD) Dyspareunia Hypoactive Sexual Desire Disorder (HSDD) Female Sexual Dysfunction (FSD) With its approval of Addyi®, FDA has now acknowledged and formally classified the distinct and separate disorders that comprise Female Sexual Dysfunction.
Slide 20: Female Sexual Arousal Disorder (FSAD)
20 Female Sexual Arousal Disorder (FSAD) FSAD is characterized primarily by an inability to attain or maintain sufficient physical sexual arousal that causes distress or interpersonal difficulty. Estimated 23-33% of women with low arousal Meta-analysis of 95 studies from 2000-2014 indicated the prev
Slide 21: Topical Sildenafil for FSAD
21 In a Phase 2a study, Topical Sildenafil (SST-6007) formulation demonstrated an increase in blood flow to the vaginal tissue in both pre- and postmenopausal women with FSAD. Daré secured global rights to SST-6007 in February, 2018 for all women’s health indications related to female sexual dysfunc
Slide 22: Topical Sildenafil clinical data
† Twelve healthy premenopausal women were studied. P<0.05 P=0.093 P=0.015 P=0.017 † 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,
Slide 23: Topical Sildenafil for FSAD: SST Formulation Technology
Topical Sildenafil is designed to directly increase local blood flow to the genital tissue. Localized action, with minimal systemic uptake of the active drug.1 6 issued patents in the U.S. on the topical delivery of Sildenafil and other PDE-5 inhibitors. Leveraging the known therapeutic benefit of o
Slide 24: Regulatory Pathway
24 Regulatory Pathway Leverage 505(b)(2) regulatory pathway and established profile of Viagra® brand. Step 1 – 2018 / 2020 (Anticipated)* Phase 2b trial – targeted to commence 2H 2018. Communicate with the FDA, early 2H 2018. Objective is to engage with the FDA to establish consensus on Phase 2b and
Slide 25: Female Sexual Dysfunction Market Landscape
Vulvar-Vaginal Atrophy Female Sexual Arousal Disorder (FSAD) Dyspareunia Hypoactive Sexual Desire Disorder (HSDD) Female Sexual Dysfunction (FSD) Where HSDD is characterized primarily by a lack of sexual desire, FSAD is characterized primarily by an inability to attain and/or maintain sufficient phy
Slide 26: Strategic Pre-Clinical Candidates: Vaginal delivery
26 $32 billion global category* Strategic Pre-Clinical Candidates Vaginal delivery of well characterized therapeutics
Slide 27: IVR Technology (Juniper)
27 IVR Technology (Juniper) Features of the Juniper intravaginal ring technology include: Sustained drug delivery. Variable dosing and duration. Single or multiple drug delivery via a solid ethylene vinyl acetate polymer matrix (without the need for a membrane or reservoir to contain the active drug
Slide 28: PT-101 Vaginally Delivered Tamoxifen for VVA
28 PT-101 Vaginally Delivered Tamoxifen for VVA Vaginally Delivered Tamoxifen to treat VVA in HR+ Breast Cancer Patients PT-101, a proprietary vaginal formulation of tamoxifen, has the potential to be a first-in-class treatment for vulvar and vaginal atrophy (VVA) in patients with hormone-receptor-p
Slide 29: Strategic Pre-Clinical Candidates: Contraceptives
29 $32 billion global category* Strategic Pre-Clinical Candidates Contraceptives that address global gaps
Slide 30: Daré's Innovation Engine
Dare’s Innovation Engine Reproductive Health Public & Private Sector Funding 30 "Innovative partnerships increase access to family planning, helping more women plan their lives and shape their futures.“ Chris Elias, President Global Development Program, Bill & Melinda Gates Foundation Major foundati
Slide 31: Value Creation: Addressing Global Gaps in Contraception
Value Creation Addressing Global Gaps in Contraception Organization Funding Source / Donor Product Name License Holder / Partner Form Indication Annual Sales / Corporate Value The Population Council USAID Paragard Teva & Cooper Surgical IUD Pregnancy Prevention $1.1B Acquisition, 2017 USAID Mirena B
Slide 32: Long-acting Injectable ORB-204 and ORB-214
32 Long-acting Injectable ORB-204 and ORB-214, injectable etonogestrel 1 The initial development on Orbis’ long-acting injectable contraceptive program was carried out under a subcontract funded by Family Health International (FHI 360) through a grant from the Bill & Melinda Gates Foundation. Precis
Slide 33: Investment Highlights
Investment Highlights 33
Slide 34: Financial Profile
34 Financial Profile Background: NASDAQ:DARE Publicly traded via reverse merger that closed July 19, 2017 Balance sheet, March 31, 2018: $15.6 million cash Non-dilutive funding NIH Funding Award April 30, 2018 Daré received a Notice of Award for the first $224,665 of the anticipated $1.9 million in
Slide 35: Management Team
Sabrina Martucci Johnson President and CEO Cypress Bioscience, WCG Advanced Tissue Sciences, Baxter Healthcare Lisa Walters-Hoffert Chief Financial Officer ROTH Capital Partners, Citicorp Securities, Bank of America, Oppenheimer & Co. David Friend, PhD Chief Scientific Officer Evofem Biosciences, CO
Slide 36: Experienced Board of Directors
Experienced Board of Directors 36 Roger Hawley (Chairman) Zogenix, Alios Biopharma, InterMune, Elan Corporation Susan Kelley, MD Cerulean, Bayer, BMS, ArQule William Rastetter, PhD Cerulean, GRAIL, Receptos, Illumina, IDEC Robin Steele, JD, LLM InterMune, Elan Corporation, Alvea, Alios Biopharma Jes
Slide 37: Daré: Management Summary
Daré: Management Summary Daré Highlights Value Drivers Corporate Strategy: To be the primary coordinating presence in women’s sexual & reproductive health Organizational Execution: Working with the top product developers as well as publicly and privately funded entities to evaluate, identify and adv
Slide 38: For more information
858-926-7655 innovations@darebioscience.com www.darebioscience.com For more information: NASDAQ:DARE