Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (July 2019)
46 slides from Dare Bioscience's investor presentation, Jul 22, 2019
Slide 1: Accelerating innovation by daring to be different
Exhibit 99.1 Accelerating innovation by daring to be different July 22, 2019
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
Vision: To become the premier innovation accelerator in women’s health. Mission: We achieve this by identifying, unlocking and advancing candidates with potential to be first-in-category, address persistent unmet needs, and promote a better quality of life for women. 3
Slide 4: Daring to be different
Daring to be different • A pure play biopharmaceutical company focused on improving the health and well being of women. Our focus areas include: • Contraception / Pregnancy Prevention • Sexual Health • Vaginal Health • Fertility • Partnering is core to our licensing and value creation strategy: • Pr
Slide 5: Product candidate pipeline
Regulatory Pre-Clinical Phase 1 Phase 2 Phase 3 Filing Bio-Adhesive Gel ^ DARE-BV1 Phase 3 Initiation 4Q 2019 Potential First-line Option for Bacterial Vaginosis Clindamycin Barrier IVR ® Ovaprene (PCT)* Top line 4Q 2019 First-in-category Non-Hormonal, Monthly Contraception Ferrous gluconate CDRH /
Slide 6: Portfolio Timeline Overview
Portfolio Timeline Overview 2019 2020 2021 2022 2023 2024 Current Development Status ~ DARE-BV1^ U.S. Phase 3 Program Regulatory Review (Bacterial Vaginosis) U.S. ~ Ovaprene® Pivotal PCT* Study Regulatory Review (Contraception) CDRH / Device Lead ^ U.S. Sildenafil Cream, 3.6% Phase 2b Program Phase
Slide 7: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
DARE-BV1 (Formerly MP-101) Clindamycin 2% gel for Bacterial Vaginosis
Slide 8: DARE-BV1 Overview
DARE-BV1 Overview Bacterial Vaginosis (BV) 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 • 86% of evaluable subjects met clinical cure endpoint at Tes
Slide 9: Gel Delivery Technology
Gel Delivery Technology Features Description Innovative Product Profile Undergoes solution to gel (sol-to-gel) • Allows product to be easily and directly placed at the site of infection In-Situ Gelation transition using body temperature as • Increased viscosity following application keeping the prod
Slide 10: DARE-BV1 Proof of Principle Study Design
Bacterial Vaginosis DARE-BV1 Investigator Initiated Proof of Principle Study Design Study Objective: Study the Efficacy and Safety of DARE-BV1 in the Treatment of Bacterial Vaginosis (n = 30) Day 1 Day 7 - 14 Day 21 - 30 Baseline Visit Test-of-Cure Visit Continued Clinical Response Visit • Single do
Slide 11: DARE-BV1 Proof of Principle Results
Bacterial Vaginosis DARE-BV1 Investigator Initiated Proof of Principle Study Design A single dose of DARE-BV1 demonstrated high clinical cure rate compared to other approved products Product Clinical (Amsel) Cure Bacteriologic (Nugent) Therapeutic Cure Cure DARE-BV1 novel gel (clindamycin) 86% 57%*
Slide 12: DARE-BV1 Opportunity Overview
DARE-BV1 Bacterial Vaginosis Opportunity Overview DARE-BV1 offers an attractive value proposition based on our belief that it has a low clinical risk profile, low development and regulatory costs, and an attractive commercial opportunity Proof of principal study complete o 86% clinical cure rate in
Slide 13: Contraception
Contraception Expected to be a $33 billion global category by 20231 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
Slide 14: Ovaprene Overview
New Contraceptive Option 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)
Slide 15: Ovaprene: Hormone product innovation
New Contraceptive Option Ovaprene® Overview Advances in hormone products have largely focused on reducing the hormone dosage, adjusting or extending the duration of protection and optimizing methods of administration. 1 2 3 4 Mirena Reduction of hormones and convenient product forms are driving new
Slide 16: Women's Preferences
New Contraceptive Option Ovaprene® Overview Women’s Preferences 1. Effective Pregnancy Prevention 2. Convenient Product Forms • Independent surveys revealed that the vaginal ring has many of the features women deemed extremely important.1 3. Method Mix • >70% of women who practice contraception curr
Slide 17: Current Contraceptive Landscape
Current Contraceptive Landscape – what’s missing? ➢ Hormone-free alternatives that are effective and easy to use 1 Least Effective Methods Hormone Free Product Landscape Marketed or in development 1,2 Spermicides / Vaginal Gels Effectiveness (72% Typical Use) Woman controlled Used “in the moment” Co
Slide 18: Ovaprene Non-hormonal Monthly Vaginal Ring
New Contraceptive Option Ovaprene® Overview 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. R
Slide 19: Ovaprene postcoital test study
New Contraceptive Option Ovaprene® Overview Ovaprene successfully prevented sperm from reaching the cervical canal in a previous human postcoital test (PCT) clinical study. • 2009 - Postcoital Assessment:1 2,3 • Open-label, single-arm, pilot safety and tolerability study. • Published in the Journal
Slide 20: Ovaprene U.S. Regulatory Strategy
New Contraceptive Option Ovaprene® Overview U.S. Regulatory Strategy • PMA with CDRH (Medical Device Division) as lead review division. • Pathway expected to be based on similar CDRH approvals - Example: Caya® diaphragm.* Step 1 – Postcoital test (PCT) 2018 / 2019* Step 2 – Pivotal Study 2020 / 2021
Slide 21: Ovaprene features desired in birth control
New Contraceptive Option Ovaprene® Overview Features Desired Most in Birth Control:1-4 Design Features of Ovaprene:5,6 + Convenience Monthly Ring Product Form (Easy to Use & Easy to Remember) Women chose rings for the convenience of a non-daily option. + Hormone Free No Hormones in the API Unique du
Slide 22: Women's Sexual Health & Wellness
Women’s Sexual Health & Wellness Female Sexual Arousal Disorder (FSAD) World market for both male and female sexual dysfunction drugs will reach 7.7 billion in 20191 1. https://www.visiongain.com/sexual-dysfunction-drugs-market-will-reach-7-7bn-in-2019-predicts-a-new-visiongain-study/
Slide 23: Sildenafil Cream, 3.6% Overview
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream, 3.6% Successful Proof of Concept • Sildenafil Cream, 3.6% improved genital blood flow in a proof-of-concept study (n=31):1 • Efficacy signal observed in both pre and postmenopausal patients • Excellent systemic/local safety and tolerability pro
Slide 24: Female sexual dysfunction: no approved products for FSAD
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream, 3.6% Vulvar-Vaginal Hypoactive Sexual Female Sexual Arousal Dyspareunia Desire Disorder Atrophy Disorder (HSDD) (FSAD) No Approved Products With its approval of Addyi®, FDA has now acknowledged and formally classified the distinct and separate
Slide 25: FSAD prevalence
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream, 3.6% 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-a
Slide 26: Oral sildenafil efficacy in women
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream, 3.6% Increased blood flow and clinical efficacy with oral sildenafil (Viagra®) in women: • Statistically significant increases in Vaginal Pulse Amplitude (VPA)1 • Statistically significant improvement in genital stimulation (FIEI)2 Pfizer VPA C
Slide 27: Sildenafil Cream Phase 1 and 2a studies
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream, 3.6% Sildenafil C T AUC Treatment N max max last Phase 1 Study of SST-6007 (Sildenafil Cream, 3.6%)1 Single Dose (ng/ml) (hr) (h*ng/ml) • Normal healthy postmenopausal women were dosed with Topical Sildenafil 20 35 mg 3.4 2.37 25.6 escalating d
Slide 28: Positive Data - Thermography Study
Positive Data - Thermography Study “The results from the first six subjects to complete all assessments indicate the utility of thermography technology to detect statistically meaningful differences in genital temperature changes, a surrogate for genital blood flow, and support the ongoing evaluatio
Slide 29: Phase 2b Program
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream, 3.6% Phase 2b Program: 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. Content Validity At Home Study Planned Type C Mee
Slide 30: Sildenafil Cream upon approval
Female Sexual Arousal Disorder (FSAD) Sildenafil Cream, 3.6% Hypoactive Sexual Vulvar-Vaginal Female Sexual Arousal Dyspareunia Desire Disorder Atrophy Disorder (HSDD) (FSAD) Sildenafil Cream, 3.6% Upon Approval With its approval of Addyi®, FDA has now acknowledged and formally classified the distin
Slide 31: Innovative Vaginal Drug Delivery
$32 billion global category* Innovative Vaginal Drug Delivery Well characterized therapeutic options
Slide 32: Intravaginal Ring Technology Platform
Intravaginal Ring (IVR) Technology Platform Daré has an exclusive, global license to novel IVR technology originally developed by Dr. Robert Langer from MIT and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School that has been further developed by Juniper Pharmaceutica
Slide 33: DARE-HRT1 Hormone Replacement Therapy
Hormone Replacement Therapy (HRT) DARE-HRT1 (bio-identical estradiol + bio-identical progesterone) HRT remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM) and has been shown $2.2 Billion U.S. Market4 to prevent bone loss and fracture.1
Slide 34: DARE-HRT1 Phase 1
Hormone Replacement Therapy (HRT) DARE-HRT1 (bio-identical estradiol + bio-identical progesterone) Phase 1 - 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 Para
Slide 35: Pregnancy Maintenance DARE-FRT1
Pregnancy Maintenance DARE-FRT1 (bio-identical progesterone) • Prevention of Pre-term Birth (PTB) • In the US, approximately 12% of pregnancies are preterm (less than 37 weeks)1 • Standard interventions include steroids, hormones and tocolytic agents to stop/slow the frequency and duration of contra
Slide 36: Vaginally Delivered Tamoxifen for VVA
Vaginally Delivered Tamoxifen for VVA DARE-VVA1 Vaginally Delivered Tamoxifen to treat VVA in HR+ Breast Cancer Patients • DARE-VVA1 (Formerly PT-101) • A proprietary formulation of tamoxifen for vaginal administration. • Potential to be the first treatment specifically approved for the treatment of
Slide 37: Vaginal Tamoxifen Proof of Concept Study
Vaginal Tamoxifen – Proof of Concept Study1 This exploratory study in four postmenopausal women diagnosed with VVA demonstrated that a self-administered vaginal suppository containing tamoxifen (20mg) dosed daily for one week and twice weekly for three months was effective in reducing vaginal pH and
Slide 38: Strategic Pre-Clinical Candidates
$32 billion global category* Strategic Pre-Clinical Candidates Contraceptives that address global gaps
Slide 39: A New Long Acting Contraceptive Option
A New Long Acting Contraceptive Option Microparticle 6 & 12 Month Injectable Contraception ORB-204 and ORB-214, injectable etonogestrel The initial development on Orbis’ long-acting injectable contraceptive program was carried out under a subcontract funded by Family Health International (FHI 360) t
Slide 40: A New Contraceptive Target DARE-RH1 CatSper
A New Contraceptive Target 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,
Slide 41: Investment Highlights
Investment Highlights
Slide 42: Financial Profile
Financial Profile NASDAQ: DARE Balance Sheet, March 31, 2019*: • Cash: $3.5 million • Common shares: 11.42 million • Common stock warrants: 3.75 million • No debt *April 2019: Underwritten public offering of 5.3 million common shares for net proceeds of approximately $5.2 million. March 2019: Second
Slide 43: Management Team
Management Team
Slide 44: Management Team
Management Team Daré Bioscience Sabrina Martucci Johnson, MSc, MIM Lisa Walters-Hoffert David Friend, PhD John Fair President & CEO Chief Financial Officer Chief Scientific Officer Chief Business Officer Cypress Bioscience, Calibr, ROTH Capital Partners, Evofem Biosciences, CONRAD, Evofem LLC, WCG,
Slide 45: Board of Directors
Board of Directors Daré Bioscience William Rastetter, PhD Jessica Grossman, MD Susan Kelley, MD Chairman Neurocrine Biosciences, IDEC, Medicines360, Sense4Baby, Bayer, BMS, ArQule, Cerulean GRAIL, Receptos, Illumina, Cerulean Johnson & Johnson Greg Matz Robin Steele, JD, LLM Sabrina Martucci Johnson
Slide 46: Corporate & Investor Communications
Corporate & Investor Communications NASDAQ: DARE Trading as DARE since July 20, 2017 @DareBioscience www.darebioscience.com 46