Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (September 2018)
42 slides from Dare Bioscience's investor presentation, Sep 5, 2018
Slide 1: Delivering innovation by daring to be different
Delivering innovation by daring to be different September 5, 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: Vision & Mission
Vision: To become the coordinating presence in women’s health. Mission: We achieve this by identifying, unlocking and advancing innovation that improves health outcomes and promotes a better quality of life for women. Vision & Mission
Slide 4: Daré Highlights
Daré Highlights Daring to be different A pure play biopharmaceutical company 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 portfoli
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 Overview
Portfolio 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. CDRH /
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: Innovation in Contraception
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 new innovation NuvaRing® Monthly, convenient vaginal ring product form. 201
Slide 9: The US Contraceptive Market is Large
The US Contraceptive Market is Large >$6 billion in US Rx sales of contraceptive products (2016).1 40 million women of reproductive age currently use a contraceptive method.2 Ready for Innovation 4 in 10 women not satisfied with their current method.2 ~50% of women opting for a shorter-acting revers
Slide 10: What Women Want from Birth Control
Women’s Preferences Effective Pregnancy Prevention Convenient Product Forms Independent surveys revealed that the vaginal ring has many of the features women deemed extremely important.1 Less Hormones A majority of women prefer a monthly option with a lower hormone dose than the pill.2 Methods not i
Slide 11: Innovation in Contraception - What's Missing?
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 insertio
Slide 12: Ovaprene: A New Contraceptive Opportunity
Ovaprene® A New Contraceptive Opportunity Monthly Non-Hormonal Opportunity
Slide 13: Ovaprene Non-hormonal, Monthly Vaginal Ring
Ovaprene® Non-hormonal, Monthly Vaginal Ring Spermiostatic Environment1 Achieved through a contraceptive-loaded silicone ring matrix. Releasing non-hormonal active Ferrous gluconate. Physical Barrier1 3-D, non-braided, fluid-permeable mesh barrier. Rx distribution (OB/GYN) – anticipated upon approva
Slide 14: Ovaprene Postcoital Assessment 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 the cervical mucus. No colposcopic abnor
Slide 15: Postcoital Test and U.S. Regulatory Strategy
Step 1 – Postcoital test (PCT) 2018 / 2019* The study is enrolling 50 couples. 25 women complete a total of 21 visits Evaluated over the course of five menstrual cycles. Each woman’s cervical mucus will be examined at several points during the study: Cycle 1 - Baseline (excludes the use of any produ
Slide 16: Features Desired in Birth Control vs Ovaprene Design
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) 15:497–506 Journal of Reproductive Medicine 2009; 54: 68
Slide 17: Women's Sexual Health & Wellness
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 18: 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 19: Female Sexual Arousal Disorder (FSAD)
Female Sexual Arousal Disorder (FSAD) FSAD is characterized primarily by an inability to attain or maintain sufficient physical sexual arousal; it is also characterized by distress or interpersonal difficulty.* Estimated 23-33% of women suffer from arousal disorder: Meta-analysis of 95 studies from
Slide 20: Topical 5% Sildenafil Citrate Cream for FSAD
Female Sexual Arousal Disorder (FSAD) Daré licensed the rights to Topical 5% Sildenafil Citrate Cream in February, 2018 for all women’s health indications related to female sexual dysfunction and female reproductive health. In a Phase 2a study, Topical 5% Sildenafil Citrate Cream formulation demonst
Slide 21: Sildenafil Clinical Study Results
† 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 22: Topical Sildenafil Cream Formulation Innovation
Female Sexual Arousal Disorder (FSAD) Topical 5% Sildenafil Citrate Cream – Formulation Innovation Topical 5% Sildenafil Citrate Cream 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
Slide 23: FDA Type C Meeting Goals
Female Sexual Arousal Disorder (FSAD) TYPE C Meeting, 3Q 2018–our meeting goals: 1.Align with the agency on key aspects of the Phase 2b and the overall clinical program to support the planned NDA, including the patient reported outcome (PRO) assessments used to accurately diagnose FSAD, and the PRO
Slide 24: Primary Endpoints for Phase 2b
Female Sexual Arousal Disorder (FSAD) Primary Endpoints for Phase 2b: While the 2016 Draft Guidance1 on arousal disorder discusses the use of the Female Sexual Function Index (FSFI) arousal questions as a possible PRO instrument for evaluating arousal improvement ─ and suggests for FSAD co-primary e
Slide 25: Phase 2b Study Length and Patient Population
Female Sexual Arousal Disorder (FSAD) Length of study: The agency is agreeable to a 12-week Phase 2b trial to assess reasonable safety and preliminary efficacy. The 2016 Draft Guidance specifies 24 weeks for each of the two Phase 3 trials. Patient population: The agency confirmed that the 2016 Draft
Slide 26: 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 27: Innovative Vaginal Drug Delivery
$32 billion global category* Innovative Vaginal Drug Delivery Well characterized therapeutic options
Slide 28: IVR Technology
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 or control the release). Cu
Slide 29: HRT Market Overview
HRT Market Overview Hormone Replacement Therapy (HRT) Hormone therapy (HT) remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM) and has been shown to prevent bone loss and fracture.1 45M women in U.S. approaching or in menopause.2 2012 N
Slide 30: DARE-HRT1 Phase Overview
DARE-HRT1 Phase 1 Overview Hormone Replacement Therapy (HRT)1 For Treatment of Vasomotor Symptoms due to Menopause 1. Data on file Proposed Study: A Phase 1, Open-Label, 3-arm Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 (80 µg and 160 µg Estradiol/ 5 mg and 10 mg P
Slide 31: Vaginally Delivered Tamoxifen to treat VVA (DARE-VVA1)
Vaginally Delivered Tamoxifen to treat VVA in HR+ Breast Cancer Patients DARE-VVA1 (Formerly 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-positive (HR+) breast cancer.
Slide 32: Strategic Pre-Clinical Candidates
$32 billion global category* Strategic Pre-Clinical Candidates Contraceptives that address global gaps
Slide 33: Dare's Innovation Engine
Dare’s Innovation Engine Reproductive Health Public & Private Sector Funding "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 foundations
Slide 34: Value Creation in Women's Reproductive Health
Organization Funding Source / Donor Product Name License Holder / Partner Form Indication Annual Sales / Corporate Value1 The Population Council USAID Gates Foundation Therapeutics MD Ring Pregnancy Prevention $20M upon FDA approval; $20M first commercial batch, milestones + royalties 2018 USAID Par
Slide 35: DARE-RH1 (CatSper)
DARE-RH1 (CatSper) A Novel Approach To Male And Female Contraception. The identification of the CatSper target represents the potential to develop a novel class of non-hormonal contraceptive products for both men and women. The discovery of a sperm-specific ion channel, CatSper, was validated in ani
Slide 36: ORB-204 and ORB-214 Injectable Etonogestrel
ORB-204 and ORB-214, injectable etonogestrel1 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. Pre-clinical studies for the 6- a
Slide 37: Investment Highlights
Investment Highlights
Slide 38: Financial Profile
Background NASDAQ:DARE Publicly traded via reverse merger that closed July 19, 2017. Balance sheet, June 30, 2018: $12.4 million in cash. Non-dilutive NIH SBIR Award (Q2-2018): Daré received a Notice of Award for the first $224,665 of an anticipated $1.9 million in grant funding 11.4 million in comm
Slide 39: Management Team
Sabrina Martucci Johnson, MSc, MIM 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 Biosc
Slide 40: Experienced Board of Directors
Experienced Board of Directors 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, Alveo, Alios Biopharma Jessic
Slide 41: 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 42: www.darebioscience.com
www.darebioscience.com NASDAQ: DARE Trading as DARE since July 19, 2017
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