Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (October 2019)
30 slides from Dare Bioscience's investor presentation, Oct 2, 2019
Slide 1: Daré Bioscience: to become the coordinating presence in women's health
Exhibit 99.1 To become the coordinating presence in women's health. We achieve this by identifying, unlocking and advancing innovation that improves health outcomes and promotes a better quality of life for women DARE IN ITALIAN, IT MEANS “ TO GIVE.” IN ENGLISH, IT MEANS “ TO BE BOLD.” To us, Daré m
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: Partnering is key to our value creation strategy
Partnering is key to our value creation strategy. We in-license products that meet a strict profile and drive commercial optionality (launch, partner or co-promote): • Product candidates that are commercially viable and attractive to strategic partners • Candidates that have a data package including
Slide 4: Development pipeline
Regulatory Pre-Clinical Phase 1 Phase 2 Phase 3 Filing Bio-Adhesive Gel ^ Phase 3 Initiation 4Q 2019 Clindamycin DARE-BV1 Potential First-line Option for Bacterial Vaginosis Barrier IVR ® First-in-category Hormone-Free, Monthly Contraceptive Ferrous gluconate Ovaprene (PCT)*CDRH / Device Lead Top li
Slide 5: Executive Management Team and Board of Directors
EXECUTIVE MANAGEMENT TEAM BOARD OF DIRECTORS Sabrina Martucci Johnson MSc, MIM William Rastetter, PhD President & CEO Chairman David Friend, PhD Chief Scientific Officer Jessica Grossman, MD Lisa Walters-Hoffert Susan Kelley, MD Chief Financial Officer Mark Walters Greg Matz Vice President of Operat
Slide 6: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
DARE-BV1 (Formerly MP-101) Clindamycin 2% gel for Bacterial Vaginosis
Slide 7: DARE-BV1 Overview
DARE-BV1 Overview 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 Test-of-Cure visit after sin
Slide 8: DARE-BV1 Proof of Concept - Trial Design
DARE-BV1 Proof of Concept - Trial 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 dose administered • Patients questioned rega
Slide 9: DARE-BV1 Proof of Concept - Trial Results
DARE-BV1 Proof of Concept - Trial Results A single dose of DARE-BV1 demonstrated high clinical cure rate compared to other approved products Product Clinical Bacteriologic Therapeutic (Amsel) Cure (Nugent) Cure Cure DARE-BV1 novel gel (clindamycin) 86% 57%* 57%* 1 Solesec® (secnidazole 2g oral granu
Slide 10: DARE-BV1 Phase 3 Pivotal and Extension Studies
DARE-BV1-001: Phase 3 Pivotal Study DARE-BV1-002: Extension Study (Data Required for NDA Filing & FDA Approval) (Value Added Data for Publication & Market Access) Study Design: Study Design: • N = 250 (age 12 and above) • N = 219 • Duration = ~30 days per subject • Duration = 60 days (post DARE-BV1-
Slide 11: Ovaprene Hormone-Free, Monthly Contraceptive
Ovaprene® Hormone-Free, Monthly Contraceptive 1 The global contraceptive category is expected to reach $33 billion by 2023 1. https://www.globenewswire.com/news-release/2017/04/06/955073/0/en/Contraceptives-Market-worth-33bn-by-2023-Global-Market-Insights-Inc.html
Slide 12: Hormone product advances and contraceptive market sales
Advances in hormone products have largely focused on reducing the hormone dosage, adjusting or extending the duration of protection and optimizing methods of administration. Mirena Reduction of hormones and convenient product forms are driving new innovation • Lo Loestrin® • Pregnancy prevention wit
Slide 13: Women's Preferences
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 currently use non-coital (not in the moment) met
Slide 14: Missing: monthly, hormone-free alternatives
Missing from the product mix are monthly, 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” Condoms Effe
Slide 15: Ovaprene Hormone-Free, Monthly Vaginal Contraceptive
Ovaprene® Hormone-Free, Monthly Vaginal Contraceptive Spermiostatic Environment1 • Achieved through a contraceptive-loaded silicone ring • Releasing non-hormonal active Ferrous gluconate. Physical Barrier1 • 3-D, knitted polymer barrier. Successful Proof of Concept Study • Ovaprene demonstrated effe
Slide 16: Ovaprene postcoital test clinical study
Ovaprene successfully prevented sperm from reaching the cervical canal in a previous human postcoital test (PCT) clinical study. 1 • 2009 - Postcoital Assessment: 2,3 • Open-label, single-arm, pilot safety and tolerability study. • Published in the Journal of Reproductive Medicine, 2009. • Patients:
Slide 17: U.S. Regulatory Strategy
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)* Step 2 – Pivotal Study* • Patient recruitment completed 2Q 2019. • Single pivotal clinical
Slide 18: Features desired in birth control and Ovaprene design features
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 monthly rings for the convenience of a non-daily option. No Hormones in the API + Hormone Free Unique dual action MOA (spermiostatic & barri
Slide 19: Sildenafil Cream, 3.6% Female Sexual Arousal Disorder
Sildenafil Cream, 3.6% Female Sexual Arousal Disorder (FSAD) 1 World market for both male and female sexual dysfunction drugs will reach 7.7 billion in 2019 1. https://www.visiongain.com/sexual-dysfunction-drugs-market-will-reach-7-7bn-in-2019-predicts-a-new-visiongain-study/
Slide 20: Sildenafil Cream Successful Proof of Concept
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 profile 505(b)(2) Regulatory Pathway • Ability to leverage the s
Slide 21: No approved products for FSAD
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 disorders that comprise Female Sexual Dysfunction. Where HSDD
Slide 22: FSAD prevalence and characterization
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
Slide 23: Oral sildenafil (Viagra) efficacy in women
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 Clinical Lab Study – Oral Viagra Pfizer Clinical Field Study –
Slide 24: Phase 1 and Phase 2a studies of Sildenafil Cream
1 Phase 1 Study of SST-6007 (Sildenafil Cream, 3.6%) Sildenafil C T AUC Treatment N max max last Single Dose (ng/ml) (hr) (h*ng/ml) • Normal healthy postmenopausal women were dosed with Topical Sildenafil escalating doses of Sildenafil Cream, 3.6%, using a 20 35 mg 3.4 2.37 25.6 cross-over study des
Slide 25: 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 26: Content validity, Type C meeting and Phase 2b at-home study
Content Validity At Home Study Planned Type C Meeting 2b At Home Study Initiation Anticipated 2019 Completed (3Q 2019) 2019 Topline Data – 4Q 2020 • A content validity study is designed to help • Type C meeting to get feedback • The Phase 2b at-home study will allow ensure the concepts we plan to me
Slide 27: Sildenafil Cream upon approval
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 distinct and separate disorders that comprise Female Sexual Dysfunc
Slide 28: Financial Profile
Financial Profile NASDAQ: DARE Balance Sheet, June 30, 2019: • Cash: $5.6 million • Common shares: 16.7 million • Common stock warrants: 3.75 million • No debt March 2019: Second Notice of Award under non-dilutive NIH SBIR grant: • Grant providing up to $1.9 million in the aggregate for Ovaprene res
Slide 29: 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 Pivotal Regulatory Review (Contraception) PCT* Study Prep CDRH / Device Lead Sildenafil Cream, 3.6%^ Phase 3 U.S. Phas
Slide 30: www.darebioscience.com
NASDAQ: DARE www.darebioscience.com
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