Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (January 2019)
47 slides from Dare Bioscience's investor presentation, Jan 7, 2019
Slide 1: Delivering innovation by daring to be different
Delivering innovation by daring to be different January 7, 2019 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 and Mission: What We Do
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. What We Do
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. At Daré, we focus on targeted delivery of products to address persistent unmet needs in women’s health. Our focus areas include: Pregnancy Prevention Sexual Health Va
Slide 5: Coordinating Presence in Women's Health
Coordinating Presence in Women’s Health Market Misalignment = A Value Creation Opportunity 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.
Slide 6: Portfolio 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: Portfolio Timeline Overview
Portfolio Timeline Overview ^505(b)(2). *Ovaprene Post Coital Test (PCT) is a pre-pivotal clinical study.. ‡HRT Phase 1 study to be conducted in Australia by Daré subsidiary. Ovaprene® (Contraception) PCT* Sildenafil Cream, 3.6%^ (FSAD) DARE-HRT1 ^‡ (Hormone Replacement Therapy) Formerly JNP-0201 Ph
Slide 8: Investment Highlights
Investment Highlights
Slide 9: 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: In Q2-2018, Daré received a Notice of Award for the first $224,665 of an anticipated $1.9 million in grant funding from a division
Slide 10: Management Team
Management Team Daré Bioscience Sabrina Martucci Johnson, MSc, MIM President and CEO Cypress Bioscience, WCG, Calibr Advanced Tissue Sciences, Baxter Healthcare Lisa Walters-Hoffert Chief Financial Officer ROTH Capital Partners, Citicorp Securities, Bank of America, Oppenheimer & Co. David Friend, P
Slide 11: 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 CooperSurgical, Cooper Companies, Hewlett Packard William Rastetter, PhD Cer
Slide 12: Program Overview
Program Overview
Slide 13: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
DARE-BV1 (Formerly MP-101) Clindamycin 2% gel for Bacterial Vaginosis
Slide 14: Successful Proof of Concept
Successful Proof of Concept Vaginal application of DARE-BV1 (clindamycin phosphate 2%) demonstrated effectiveness against BV in a proof-of-concept investigator initiated study in women (n=30):1 88% of evaluable subjects met clinical cure endpoint at Test-of-Cure visit after single dose administered
Slide 15: Bacterial Vaginosis Symptoms & Causes
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 16: BV diagnostic 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 B
Slide 17: 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 18: 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 19: 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 20: Contraception Expected to be a $33 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 Expected to be a $33 billion global category by 20231
Slide 21: Ovaprene Overview
Successful Proof of Concept Study Ovaprene demonstrated effectiveness in preventing sperm from entering the cervical canal in a proof-of-concept study in women (n=20):1 No viable sperm in the cervical mucus No colposcopic abnormalities CDRH (Device) Regulatory Pathway Single pivotal clinical trial e
Slide 22: 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 23: Women's Preferences
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 24: What's Missing in Contraception?
Spermicides / Vaginal Gels Effectiveness (72% Typical Use) Woman controlled Used “in the moment” Condoms Effectiveness (82% Typical Use) Not woman controlled Used “in the moment” Diaphragms Effectiveness (88% Typical Use) Woman controlled Used “in the moment” Long-acting IUD Effectiveness (99% Typic
Slide 25: 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 26: 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 27: 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 28: Features Desired Most 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 29: Female Sexual Arousal Disorder market
1. https://www.visiongain.com/sexual-dysfunction-drugs-market-will-reach-7-7bn-in-2019-predicts-a-new-visiongain-study/ 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 30: Sildenafil Cream, 3.6% Successful Proof of Concept
Successful Proof of Concept Sildenafil Cream, 3.6% cream improved genital blood flow in a proof-of-concept study (n=35):1 Efficacy signal observed in both pre and postmenopausal patients Excellent systemic/local safety and tolerability profile 505(b)(2) Regulatory Pathway Ability to leverage the saf
Slide 31: Female Sexual Dysfunction disorders and approved products
Vulvar-Vaginal Atrophy Female Sexual Arousal Disorder (FSAD) Dyspareunia Hypoactive Sexual Desire Disorder (HSDD) With its approval of Addyi®, FDA has now acknowledged and formally classified the distinct and separate disorders that comprise Female Sexual Dysfunction. Where HSDD is characterized pri
Slide 32: FSAD prevalence
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 2000-2014 indicated the prevalence of
Slide 33: Sildenafil clinical study 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 34: Formulation Innovation
Formulation Innovation Sildenafil Cream, 3.6% designed to directly increase local blood flow to the genital tissue. The formulation delivers localized action, with minimal systemic uptake of the active drug.1 Leveraging the known therapeutic benefit of oral sildenafil to stimulate increased blood fl
Slide 35: Phase 2b planning and Type C meeting
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 36: Female sexual dysfunction landscape
Vulvar-Vaginal Atrophy Female Sexual Arousal Disorder (FSAD) Dyspareunia Hypoactive Sexual Desire Disorder (HSDD) With its approval of Addyi®, FDA has now acknowledged and formally classified the distinct and separate disorders that comprise Female Sexual Dysfunction. Where HSDD is characterized pri
Slide 37: Innovative Vaginal Drug Delivery
$32 billion global category* Innovative Vaginal Drug Delivery Well characterized therapeutic options
Slide 38: Intravaginal Ring (IVR) Technology Platform
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 39: Hormone Replacement Therapy DARE-HRT1
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 statement supports HRT in peri- and post-menopausal women
Slide 40: Phase 1/2a DARE-HRT1 proposed study
Phase 1/2a - Hormone Replacement Therapy (HRT) DARE-HRT1 for the treatment of VMS due to menopause – combination bio-identical estradiol and progesterone in a convenient 28 day IVR Proposed Study: A Phase 1, Open-Label, 3-arm Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE
Slide 41: Vaginally Delivered Tamoxifen 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 42: Strategic Pre-Clinical Candidates
$32 billion global category* Strategic Pre-Clinical Candidates Contraceptives that address global gaps
Slide 43: Daré'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 44: Value Creation in Women's Reproductive Health
Organization Funding Source / Donor Product Name License Holder / Partner Form Indication Annual Sales / Corporate Value The Population Council USAID Gates Foundation Therapeutics MD Ring Pregnancy Prevention 2018 $20M upon FDA approval; $20M first commercial batch, milestones + royalties1 USAID Par
Slide 45: A Novel Approach To Male And Female Contraception
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 animal models where it
Slide 46: 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 47: Contact: www.darebioscience.com
www.darebioscience.com Corporate & Investor Communications NASDAQ: DARE Trading as DARE since July 20, 2017
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