Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (June 2020)
38 slides from Dare Bioscience's investor presentation, Jun 8, 2020
Slide 1: Daré – To Be Bold
Exhibit 99.1 DARE IN ITALIAN, IT MEANS “ TO GIVE.” IN ENGLISH, IT MEANS “ TO BE BOLD.” June 8, 2020
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: We Are Accelerating Innovation in Women's Health
WE ARE ACCELERATING INNOVATION IN WOMEN’S HEALTH We're driven by a mission to accelerate a With clinical trials underway, our initial focus diverse portfolio of novel therapies for women areas include contraception, fertility, and that expand treatment options, improve sexual and vaginal health. out
Slide 4: Partnering is core to our strategy
We partner so we can… Accelerate exciting new products Develop new solutions to address persistent unmet needs Become a pipeline resource for large and emerging commercial companies Partnering is core to our strategy Drive new innovation We look for… Highly differentiated products with attractive ma
Slide 5: Product pipeline
PARTNERS PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 / PIVOTAL REGULATORY FILING DARE-BV1^ Bacterial Vaginosis Potential First-line Option for Bacterial Vaginosis (BV) Bio-adhesive gel, clindamycin 2% Ovaprene® Hormone-Free, Monthly Contraception First-in-category Hormone-Free Monthly Contraception Monthly
Slide 6: Anticipated topline data timeline 2020-2023
2020 2021 2022 2023 DARE-BV1^ Phase 3 Bacterial Vaginosis Topline Data Sildenafil Cream, 3.6%^ Phase 2b FSAD Topline Data Ovaprene® Pivotal Contraception Topline Data 6 Timeline reflects management’s current estimates and constitutes a forward-looking statement subject to qualifications noted elsewh
Slide 7: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
Slide 8: Bacterial Vaginosis – What is the clinical issue?
Bacterial Vaginosis (BV) - What is the clinical issue? Frequently recurring infection that can be difficult to treat • The most common vaginal infection in women ages 15-441 • Estimated to affect ~21 million women in the U.S.1 • Current prescription drugs are less than optimal with clinical cure rat
Slide 9: DARE-BV1 Proof of Concept Study
DARE-BV1 (WOMEN AGES 15-44) 1 Investigator Initiated Proof of Concept Study Clinical Bacteriologic Therapeutic Product (Amsel) Cure (Nugent) Cure Cure DARE-BV1 86% 57%* 57%* 2 Solosec® (secnidazole 2g oral granules) 53-68% 40-46% 35-40% Clindesse®3 clindamycin phosphate 41-64% 45-57% 30-42% Vaginal
Slide 10: DARE-BV1 Phase 3 study design
DARE-BV1 Single administration of DARE-BV1 or placebo N ~220 subjects (age 12 and above) Duration ~30 days per subject Diagnosis - Bacterial vaginosis Definitions: Primary Endpoint: Clinical Cure (Day 21-30): Resolution of the abnormal vaginal discharge associated with BV; Negative 10% KOH “whiff te
Slide 11: Ovaprene: Investigational Hormone-Free, Monthly Contraceptive
Ovaprene® Investigational Hormone-Free, Monthly Contraceptive 1 The U.S. contraceptive market size is projected to reach USD 9.6 billion by 2027 expanding at a CAGR of ~4.2% 2 ~37 million U.S. women of reproductive age are estimated to currently use a contraceptive method 1. Grand View Research repo
Slide 12: Contraception – what kinds of products are successful?
Contraception – what kinds of products are successful? 1 2 3 Mirena Mirena® Hormone IUD Lo Loestrin® NuvaRing® (levonorgestrel-releasing intrauterine system) 52mg (norethindrone acetate and ethinyl estradiol, ethinyl estradiol tablets) (etonogestrel/ethinyl estradiol vaginal ring) Physician inserted
Slide 13: What features are women seeking?
Contraception – what kinds of features are women seeking ? Effective pregnancy prevention Less Hormones • A majority of women prefer a monthly option with a lower hormone dose than the standard birth control pill.1 Convenient dosing forms • Independent surveys revealed that the vaginal ring has many
Slide 14: What products are hormone-free?
1,2 Contraception – what products are hormone-free? Least Effective Most Effective 14 1. Trussell J. Contraceptive Efficacy. In Hatcher RA, Trussell J, Nelson AL, Cates W, Kowal D, Policar M. Contraceptive Technology: Twentieth Revised Edition. New York, NY: Ardent Media, 2011. 2. http://www.contrac
Slide 15: What's missing from hormone-free options?
Contraception – what’s missing from hormone-free options? Least Effective Easy-to-use, monthly option with effectiveness approaching hormonal methods Most Effective 15
Slide 16: Ovaprene design features
Ovaprene® Investigational Hormone-Free, Monthly Contraceptive Desired Features of Birth Control Products:1-4 Design Features of Ovaprene:5-7 Physical Barrier 8 86% - 91% Expected Typical Use Effectiveness Three-dimensional, knitted polymer barrier + Efficacy Approaching Hormone Contraception No Horm
Slide 17: Ovaprene U.S. Regulatory Strategy
Ovaprene® Investigational Hormone-Free, Monthly Contraceptive U.S. Regulatory Strategy1 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 2 • Postcoital Test (PCT) Study - Com
Slide 18: Ovaprene Commercial License Agreement with Bayer
Ovaprene® Investigational Hormone-Free, Monthly Contraceptive Ovaprene Commercial License Agreement with Bayer1 Mirena® is the #1 January 2020 - Bayer, marketers of the $1 billion Mirena contraceptive franchise, and Daré prescribed IUD announced that the companies signed a license agreement under wh
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: FSAD – what is the clinical issue?
Sildenafil Cream, 3.6% FSAD - what is the clinical issue? Female Sexual Arousal Disorder (FSAD), is characterized primarily by an inability to attain or maintain sufficient genital arousal during sexual activity and, of the female sexual function disorders, is the analogous to erectile dysfunction (
Slide 21: FSAD – what is the incidence?
FSAD - what is the incidence? Meta-analysis of 95 studies from 2000-2014 indicated the prevalence of Female Sexual Dysfunction in premenopausal women worldwide is 40.9%, and difficulty with arousal alone is 23%.1 • 33% of women in the U.S. age 21 to 60 (approximately 20 million women), experience sy
Slide 22: Topically administered Sildenafil Cream
Sildenafil Cream, 3.6% Topically administered Sildenafil Cream1 is… • A PDE5 inhibitor utilized in ED medications for men (Viagra®), • Designed to increase local blood flow to provide an improvement in genital arousal response, • Applied topically, avoiding hepatic first-pass metabolism response res
Slide 23: Oral Viagra studies in women
Sildenafil Cream, 3.6% Statistically significant increases in Statistically significant improvement in Vaginal Pulse Amplitude (VPA)1 genital stimulation (FIEI)2 Pfizer VPA Clinical Lab Study – Oral Viagra Pfizer Clinical Field Study – Oral Viagra Mean and Maximum VPA† Improvement on FIEI Questions†
Slide 24: Phase 1 and Phase 2a studies
Sildenafil Cream, 3.6% 1 Phase 1 Study of SST-6007 (Sildenafil Cream, 3.6%) Phase 1 Study Normal healthy postmenopausal women were dosed with escalating doses of Sildenafil Cream, 3.6%, using a cross-over study design. • Sildenafil Cream had significantly lower systemic exposure compared to a 50 mg
Slide 25: Positive Data – Thermography Study
Sildenafil Cream, 3.6% Positive Data – Thermography Study* Positive findings for Sildenafil Cream, 3.6% (as shown in Figure 1.) Sildenafil Cream • Positive cognitive arousal responses were noted. • Significantly greater increases in genital temperature after application of Sildenafil Cream compared
Slide 26: Phase 2b – At Home Study
Sildenafil Cream, 3.6% Phase 2b – At Home Study The Phase 2b study is designed to evaluate Sildenafil Cream versus placebo over twelve weeks of dosing following both a non-drug and placebo run-in period. • In the Phase 2b study women will use Sildenafil Cream and placebo in their home setting. • Pri
Slide 27: Vaginal Drug Delivery
Vaginal Drug Delivery New prescription drug delivery options for women
Slide 28: Vaginal Drug Delivery Technology – IVR
Vaginal Drug Delivery Technology - IVR The Vaginal Route of Drug Administration1 • Vaginal drug delivery offers many potential advantages due to the large surface area, a dense network of blood vessels and high elasticity due to presence of smooth muscle fibers • Recognized advantages include: compa
Slide 29: DARE-HRT1 hormone replacement therapy IVR
Vaginal Drug Delivery Technology - IVR DARE-HRT1 A combination bio-identical estradiol + bio-identical progesterone IVR for hormone replacement therapy Hormone Replacement Therapy (HRT) HRT remains the most effective treatment for vasomotor symptoms Planned Phase 1 VMS/HRT STUDY (VMS) and the genito
Slide 30: DARE-FRT1 progesterone IVR
Vaginal Drug Delivery Technology - IVR DARE-FRT1 A bio-identical progesterone IVR for the prevention of preterm birth and IVF/fertility support Prevention of Preterm Birth (PTB) 6 The rate of premature birth in the United States rose in 2018 for the fourth straight year after a steady decline from 2
Slide 31: DARE-VVA1 vaginal tamoxifen
Vaginal Drug Delivery DARE-VVA1 A proprietary formulation of tamoxifen for vaginal administration Vulvar and vaginal atrophy (VVA) A chronic condition characterized by pain during intercourse, vaginal dryness and irritation Potential to be the first treatment specifically approved for the treatment
Slide 32: Vaginal Tamoxifen – Proof of Concept Study
Vaginal Drug Delivery 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 33: User-Controlled Long Acting Reversible Contraception / Microchips Technology
User-Controlled Long Acting Reversible Contraception (UC-LARC) / Microchips Technology
Slide 34: DARE-LARC1 design features
DARE-LARC1 User-Controlled Long Acting Reversible Contraception Design Features of the Technology: • Drug Storage • Individual doses are stored in micro-reservoir arrays • Reservoirs are hermetically sealed at room temperature • Thin membranes over each reservoir protect drug post-sealing • Drug Rel
Slide 35: DARE-LARC1 Gates Foundation funding
DARE-LARC1 User-Controlled Long Acting Reversible Contraception The Bill & Melinda Gates Foundation has strong interest in family planning. An estimated 215 million women in developing countries do not have access to contraception. Funding Grant to understand user needs and define the product concep
Slide 36: Daré Financial Summary
Daré Financial Summary Q1-2020 Financial Highlights: • Net cash raised from stock sales, warrant exercises and license fee: $7.9 million • Cash and equivalents (3/31/2020): $5.0 million Updates through May 12, 2020: • Net cash raised from stock sales: $2.0 million • Common shares o/s: 26.6 million •
Slide 37: Management Team and Board of Directors
MANAGEMENT TEAM BOARD OF DIRECTORS Sabrina Martucci Johnson MSc, MIM, President & CEO William Rastetter, PhD. Chairman David Friend, PhD, Chief Scientific Officer Cheryl Blanchard, PhD Lisa Walters-Hoffert, Chief Financial Officer Jessica Grossman, MD John Fair, Chief Strategy Officer Susan Kelley,
Slide 38: www.darebioscience.com
NASDAQ: DARE www.darebioscience.com