Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (December 2018)
47 slides from Dare Bioscience's investor presentation, Dec 10, 2018
Slide 1: Delivering innovation by daring to be different
Delivering innovation by daring to be different December 10, 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 Presence in Women's Health
Coordinating Presence in Women’s Health Linking innovation to commercialization 1. https://www.prnewswire.com/news-releases/womens-health-market-size-worth-513-billion-by-2025--cagr-39-grand-view-research-inc-651064753.html Global Women's Health Market Worth $51 Billion by 2025 - CAGR: 3.9% 1 Women’
Slide 6: Product pipeline timeline
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. ^505(b)(2). *Ovaprene Post
Slide 7: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
DARE-BV1 (Formerly MP-101) Clindamycin 2% gel for Bacterial Vaginosis
Slide 8: Bacterial Vaginosis (BV) Symptoms & Causes of BV
BV is the most commonly reported vaginal infection in women ages 15-44.1 BV is characterized by a shift in the vaginal flora from the dominant Lactobacillus to a polymicrobial flora.2 BV has been associated with serious health issues, including preterm births, pelvic inflammatory disease, increased
Slide 9: Bacterial Vaginosis diagnosis criteria
BV is characterized by the presence of three of the following four criteria: Vaginal pH of >4.5 Clue cells on saline wet mount Release of a fish amine odor, A characteristic thin, homogenous vaginal discharge. In 1991, Nugent et al. described a Gram stain scoring system of vaginal smears to diagnose
Slide 10: Bacterial Vaginosis Market Opportunity
In the US, an estimated 21 million women aged 14-49 years (approximately 29%) are infected with BV.1,2 BV leads to symptoms including abnormal vaginal discharge and odor that are unpleasant and disrupt and interfere with a woman’s relationships and general quality of life. According to IMS/IQVIA dat
Slide 11: DARE-BV1 proof-of-principle overview
DARE-BV1 met clinical cure endpoint in a proof-of-principle investigator initiated clinical study for the treatment of BV. Novel proprietary hydrogel-based drug delivery technology has been developed for use in intravaginal and urology applications. Designed to improve efficacy through unique featur
Slide 12: DARE-BV1 Proof of Principle Study Design
Bacterial Vaginosis DARE-BV1 (Formerly MP-101) Proof of Principle Study Design Eligibility: Female subjects 18 years or older with confirmed clinical diagnosis of BV Primary Endpoint: Clinical Cure at Test-of-Cure visit (defined as resolution of clinical findings from baseline visit); Secondary Endp
Slide 13: DARE-BV1 Proof-of-Principle Study Summary
Bacterial Vaginosis DARE-BV1 (Formerly MP-101) Proof-of-Principle Study Summary 30 subjects; 26 subjects were evaluable Test-of-Cure Visit (Day 7 – 14): 88% (n = 23) subjects achieved clinical cure 5 of 9 subjects had therapeutic cure and 6 of 9 had bacteriologic cures Continued Clinical Response Vi
Slide 14: DARE-BV1 Opportunity Highlights
Bacterial Vaginosis DARE-BV1 (Formerly MP-101) Opportunity Highlights DARE-BV1 offers an attractive value proposition based on an established clinical profile of clindamycin, 505(b)(2) regulatory pathway and an attractive commercial opportunity. 505(b)(2) Regulatory Pathway Single Phase 3 clinical t
Slide 15: 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 16: 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 17: 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 18: 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 19: 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 20: Ovaprene: A New Contraceptive Opportunity
Ovaprene® A New Contraceptive Opportunity Monthly Non-Hormonal Opportunity
Slide 21: 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 22: Ovaprene 2009 Postcoital Assessment
2009 - Postcoital Assessment:1 Open-label, single-arm, pilot safety and tolerability study. Published in the Journal of Reproductive Medicine, 2009. Patients: N= 20; all women completed one cycle of use. Results: Postcoital testing revealed no viable sperm in the cervical mucus. No colposcopic abnor
Slide 23: 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 24: Features desired in birth control and 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 25: 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 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: 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 28: Oral sildenafil clinical study data in FSAD
† 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 29: Sildenafil Cream, 3.6% Formulation Innovation
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream, 3.6% – Formulation Innovation Sildenafil Cream, 3.6% 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
Slide 30: Sildenafil Cream development plan
Continue to explore additional clinical and non-clinical work that might be valuable or required to support the overall program and the anticipated design of the Phase 2b. Planned Type C Meeting Content Validity Initiated (4Q 2018) At Home Study 2b At Home Study Topline Data – 4Q 2020 A content vali
Slide 31: 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 32: Innovative Vaginal Drug Delivery
$32 billion global category* Innovative Vaginal Drug Delivery Well characterized therapeutic options
Slide 33: 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 34: HRT Market Overview
HRT Market Overview Hormone Replacement Therapy (HRT) HRT 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 NAMS consensus sta
Slide 35: DARE-HRT1 Phase Overview
DARE-HRT1 Phase 1 Overview Hormone Replacement Therapy (HRT) DARE-HRT1 for the treatment of VMS due to menopause 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 Progesterone Intrav
Slide 36: DARE-VVA1 Vaginally Delivered Tamoxifen
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 37: Strategic Pre-Clinical Candidates
$32 billion global category* Strategic Pre-Clinical Candidates Contraceptives that address global gaps
Slide 38: 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 39: 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 40: 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 41: 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 42: Investment Highlights
Investment Highlights
Slide 43: Financial Profile
Background NASDAQ:DARE Publicly traded via reverse merger that closed July 19, 2017. Balance sheet, September 30, 2018: $9.5 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
Slide 44: 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 45: Board of Directors
Roger Hawley (Chairman) Zogenix, Alios Biopharma, Cypress Bioscience, InterMune, Elan Corporation, GSK Jessica Grossman, MD Medicines360, Sense4Baby, Johnson & Johnson Susan Kelley, MD Cerulean, Bayer, BMS, ArQule Greg Matz Cooper Companies, CooperVision, Hewlett Packard William Rastetter, PhD Cerul
Slide 46: 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 47: Corporate & Investor Communications
www.darebioscience.com Corporate & Investor Communications Daré Bioscience NASDAQ: DARE Trading as DARE since July 20, 2017
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