Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (March 2020)
40 slides from Dare Bioscience's investor presentation, Mar 16, 2020
Slide 1: Daré Bioscience: mission in women's health
Exhibit 99.1 To become th rdinating 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 means
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: Product candidate pipeline
PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING Phase 3 - 2020 DARE-BV1^ Bacterial Vaginosis Potential First-line Option for Bacterial Vaginosis (BV) Bio-adhesive gel, clindamycin 2% Pivotal Study Start - 2H 2020 Ovaprene® Hormone-Free, Monthly Contraception First-in-category Hormone-Free, Mo
Slide 5: Portfolio Timeline Overview
Portfolio Timeline Overview 2020 2021 2022 2023 2024 DARE-BV1^ U.S. Phase 3 Program Bacterial Vaginosis Regulatory Review Ovaprene® PCT Study IDE & Pivotal Pivotal Clinical Study U.S. Contraception Completed Preparation Regulatory Review CDRH / Device Lead Sildenafil Cream, 3.6%^ Phase 3 Program U.S
Slide 6: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
Slide 7: DARE-BV1 highlights: proof of concept, pathway, market
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 single dose administe
Slide 8: DARE-BV1 Proof of Concept – Clinical Trial Design
DARE-BV1 Proof of Concept – Clinical 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 questi
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 FDA-approved products1 Product Clinical Bacteriologic Therapeutic (Amsel) Cure (Nugent) Cure Cure DARE-BV1 novel gel (clindamycin) 86% 57%* 57%* Solosec®2 (secnidazole 2g oral granule
Slide 10: DARE-BV1-001: Phase 3 Clinical Study Design
DARE-BV1-001: Phase 3 Clinical Study Design* • N = ~220 (age 12 and above) • Duration = ~30 days per subject Phase 3 Clinical Study Design • Diagnosis = Bacterial vaginosis Day 7 – 14 Day 21 – 30 Study Objectives: Day 1 Secondary Endpoint Primary Endpoint Baseline Visit (Test-of-Cure Visit) (Test-of
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: Advances in hormone contraceptive products
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 Mirena Reduction of hormones and convenient product forms are driving new innovation • Mirena® Product Family • Physicia
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 successful postcoital test study
Ovaprene® Hormone-Free, Monthly Vaginal Contraceptive Successful postcoital test (PCT) Study using Predictive Contraceptive Endpoint Physical Barrier1 • The PCT Clinical Study Met its Primary Endpoint Three-dimensional, knitted polymer barrier • Specifically, in 100% of women and cycles, an average
Slide 16: U.S. Regulatory Strategy
U.S. Regulatory Strategy* Premarket approval (PMA) with the Center for Devices and Radiological Health (CDRH) as lead review division Step 1 (Completed) The PCT Clinical Study Met its Primary Endpoint • PCT Study - Completed 4Q 2019 Ovaprene prevented the requisite number of sperm from reaching the
Slide 17: Design Features of Ovaprene
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 18: Ovaprene Commercial License Agreement with Bayer
Ovaprene® Commercial License Agreement with Bayer • January 13, 2020 Bayer, marketers of the $1 billion Mirena contraceptive franchise, and Daré announced that the companies signed a license agreement under which Bayer may commercialize Ovaprene in the United States once approved by the FDA. • Bayer
Slide 19: Sildenafil Cream, 3.6% Female Sexual Arousal Disorder
Sildenafil Cream, 3.6% Female Sexual Arousal Disorder (FSAD) 1 The global female sexual dysfunction treatment market is expected to grow at ~37% CAGR from 2019 - 2023 1. https://www.businesswire.com/news/home/20190628005277/en/Global-Female-Sexual-Dysfunction-Treatment-Market-2019-2023
Slide 20: Sildenafil Cream: proof of concept, pathway, market
Successful Proof of Concept • Sildenafil Cream, 3.6% improved genital blood flow (n=31)1 and increased genital temperature (n=6)2 in proof of concept studies • Efficacy signal observed in both pre and postmenopausal patients • Excellent systemic/local safety and tolerability profile 505(b)(2) Regula
Slide 21: Female sexual dysfunction disorders landscape
Hormone Mediated CNS Mediated PDE5 Inhibitor Vulvar-Vaginal Hypoactive Sexual Female Sexual Dyspareunia Desire Disorder Atrophy (HSDD) Arousal Disorder (FSAD) No Approved Products Of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men
Slide 22: FSAD prevalence and characteristics
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) studies 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, Phase 2b
Content Validity Type C Meeting Phase 2b At Home Study Completed 3Q 2019 Completed 4Q 2019 Initiation Planned 2020 • A content validity study was designed to help • Type C meeting with the FDA • The Phase 2b at-home study will allow ensure the concepts we plan to measure are completed and alignment
Slide 27: Sildenafil Cream positioning upon approval
Hormone Mediated CNS Mediated PDE5 Inhibitor Vulvar-Vaginal Hypoactive Sexual Female Sexual Dyspareunia Desire Disorder Atrophy (HSDD) Arousal Disorder (FSAD) Sildenafil Cream, 3.6% Upon Approval With its approval of Addyi®, FDA acknowledged and formally classified the distinct and separate disorder
Slide 28: Microchips Program: User-Controlled Long Acting Reversible Contraception
Microchips Program User-Controlled Long Acting Reversible Contraception (UC-LARC)
Slide 29: How the Microchips Technology is Designed to Work
How the Microchips Technology is Designed to Work Drug Storage • Individual doses are stored in micro-reservoir arrays • Reservoirs are hermetically sealed at room temperature • Thin metallic membranes over each reservoir protect drug post-sealing Drug Release • Drug doses are initiated automaticall
Slide 30: Bill & Melinda Gates Foundation funding and interest
The Bill & Melinda Gates Foundation has strong interest in family planning. An estimated 215m women in developing countries don’t have access to contraception. Funding Grant to understand user needs and define the product concept 2013 Favorable response from Sub-Saharan Africa – Sub-dermal implant u
Slide 31: Innovative Vaginal Drug Delivery Technology
Innovative Vaginal Drug Delivery Technology Well characterized therapeutic options for innovation in Women’s Health 1
Slide 32: Intravaginal Ring (IVR) Technology Platform
INTRAVAGINAL RING (IVR) TECHNOLOGY PLATFORM Innovation in Drug Delivery • Features of the 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 membra
Slide 33: DARE-HRT1 Treating Vasomotor / Menopause Related Symptoms
DARE-HRT1 (bio-identical estradiol / bio-identical progesterone) DARE-HRT1 - Treating Vasomotor / Menopause Related Symptoms 4 Hormone Replacement Therapy (HRT) remains the most effective treatment for $2.2 Billion U.S. Market vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM
Slide 34: DARE-HRT1 Phase 1 VMS/HRT Study
DARE-HRT1 (bio-identical estradiol / bio-identical progesterone) Phase 1 – VMS/HRT STUDY 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 Eval
Slide 35: DARE-FRT1 Pregnancy Maintenance
DARE-FRT1 (bio-identical progesterone) Pregnancy Maintenance • 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: DARE-VVA1 Vaginally Delivered Tamoxifen
DARE-VVA1 (Tamoxifen) Vaginally Delivered Tamoxifen to treat VVA in Hormone-Receptor Positive (HR+) Breast Cancer Patients • DARE-VVA1 • A proprietary formulation of tamoxifen for vaginal administration. • Potential to be the first treatment specifically approved for the treatment of vulvar and vagi
Slide 37: Vaginal Tamoxifen – Proof of Concept Study
DARE-VVA1 (Tamoxifen) 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 r
Slide 38: Microchips acquisition, cash raised and grants
NASDAQ: DARE Q4-2019: Acquisition of Microchips Biotech • Closing cash acquired (less transaction related expenses): $5.7 million • Issuance of ~3 million DARE common shares • Cash resources that are not committed to funding the contraceptive program activities under the grant from the Bill & Melind
Slide 39: 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 Cheryl Blanchard, PhD Chief Scientific Officer Lisa Walters-Hoffert Jessica Grossman, MD Chief Financial Officer John Fair Susan Kelley, MD Chief Business
Slide 40: www.darebioscience.com
NASDAQ: DARE www.darebioscience.com