Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (September 2019)
40 slides from Dare Bioscience's investor presentation, Sep 9, 2019
Slide 1: Exhibit 99.1 September 9, 2019
Exhibit 99.1 September 9, 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 partner in women’s health working to address persistent unmet need in women’s health. Mission: We plan to achieve this by utilizing a novel innovation acceleration model that we believe enables us to identify and advance unique and differentiated product candidates capa
Slide 4: Partnering is key to our licensing and value creation strategy
Partnering is key to our licensing and value creation strategy: • Product candidates that are commercially viable and attractive to strategic partners • Candidates that have a data package including a proof-of-concept and/or the ability to leverage a 505(b)(2) regulatory pathway • Candidates with th
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 Clindamycin Potential First-line Option for Bacterial Vaginosis Barrier IVR ® Ovaprene (PCT)* CDRH / Device Lead Top line 4Q 2019 Hormone-Free, Monthly Contraceptive Ferrous gluconate First-i
Slide 6: Portfolio Timeline Overview
Portfolio Timeline Overview 2019 2020 2021 2022 2023 2024 Current Development Status ~ DARE-BV1^ U.S. Regulatory Review (Bacterial Vaginosis) Phase 3 Program U.S. Ovaprene® Pivotal ~ PCT* Study Regulatory Review (Contraception) CDRH / Device Lead Sildenafil Cream, 3.6%^ Phase 3 U.S. Phase 2b Program
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) Successful Proof of Concept
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 Test-of-Cure visit af
Slide 9: Bacterial Vaginosis (BV) Study Design
Bacterial Vaginosis (BV) 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 regarding • Patients
Slide 10: DARE-BV1 clinical cure rate compared to approved products
Bacterial Vaginosis (BV) 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 granules) 53-68% 40-46
Slide 11: Ovaprene Hormone-Free, Monthly Contraceptive
Ovaprene® Hormone-Free, Monthly Contraceptive 1 The global contraceptive category is expected to reach $33 billion by 2031 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 12: Advances in hormone products and reduction of hormones
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 from the product mix: 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 prior 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) 2018 / 2019* Step 2 – Pivotal Study 2020 / 2021* • Patient recruitment completed 2Q 2019. •
Slide 18: Features Desired in Birth Control and Ovaprene Design
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 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) increased blood flow and 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, 3.6%
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: Phase 2b Program
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 Meeting 2b At Home Study Initiation Anticipated 2019 Completed (
Slide 27: Sildenafil Cream, 3.6% 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: Innovative Vaginal Drug Delivery
Innovative Vaginal Drug Delivery Well characterized therapeutic options for innovation in Women’s Health 1
Slide 29: 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 30: 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 $2.2 Billion U.S. Market treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM
Slide 31: 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 32: 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 33: DARE-VVA1 Vaginally Delivered Tamoxifen
DARE-VVA1 (Tamoxifen) Vaginally Delivered Tamoxifen to treat VVA in Hormone Receptor Positive (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
Slide 34: 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 35: Investment Highlights
Investment Highlights
Slide 36: 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 37: Management Team
Management Team
Slide 38: Executive Team
EXECUTIVE TEAM 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, Advanced Tissue S
Slide 39: Board of Directors
BOARD OF DIRECTORS 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 CooperSurgical
Slide 40: Corporate & Investor Communications
Corporate & Investor Communications NASDAQ: DARE Trading as DARE since July 20, 2017 www.darebioscience.com 40
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