Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (October 2020)
38 slides from Dare Bioscience's investor presentation, Oct 6, 2020
Slide 1: Exhibit 99.1 October 06, 2020
Exhibit 99.1 October 06, 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 partner so we can… Partnering is core to our strategy
We partner so we can… Accelerate exciting new products Develop new solutions to address persistent unmet needs Partnering is core to our strategy Become a pipeline resource for large and emerging commercial companies Partnering is core to our strategy Drive new innovation We look for… Highly differe
Slide 4: Product candidate 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) Bioadhesive gel, clindamycin 2% Ovaprene® Hormone-Free, Monthly Contraception First-in-category Hormone-Free Monthly Contraception Monthly,
Slide 5: Expected topline data timeline 2020-2023
2020 2021 2022 2023 DARE-BV1^ Phase 3 Bacterial Vaginosis Topline Data DARE-HRT1^ Phase 1 Hormone Replacement Therapy Topline Data Sildenafil Cream, 3.6%^ Phase 2b FSAD Topline Data Ovaprene® Pivotal Contraception Topline Data 5 Timeline reflects management’s current estimates and constitutes a forw
Slide 6: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
Slide 7: Bacterial Vaginosis (BV) - 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 8: 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%* Solosec®2 53-68% 40-46% 35-40% (secnidazole 2g oral granules) ®3 Clindesse clindamycin phosphate 41-64% 45-57% 30-42% Vaginal
Slide 9: DARE-BV1 Ongoing Phase 3 Study
DARE-BV1 (Ongoing Phase 3 Study) Single administration of DARE-BV1 or placebo N~280 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; Neg
Slide 10: 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 11: 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 12: Contraception: what features are women seeking?
Contraception: what features are women seeking? Effectiveness (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 of 2
Slide 13: Contraception: what products are hormone-free?
1,2 Contraception: what products are hormone-free? Least Effective Most Effective 13 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.contrace
Slide 14: Contraception: 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 14
Slide 15: 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 Three-dimensional, knitted polymer 86% - 91% Expected Typical Use Effectiveness barrier + Efficacy Approaching Hormone Contraception No Horm
Slide 16: 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 Ovaprene prevented the requisite nu
Slide 17: 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, marketer of the $1 billion Mirena contraceptive franchise, and prescribed IUD Daré announced that the companies signed a license agreement under whi
Slide 18: 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 19: 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 20: FSAD - what is the incidence?
Sildenafil Cream, 3.6% 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 Market research estimates: • 33% of women in the U.S. age 21 to
Slide 21: Topically administered Sildenafil Cream
Sildenafil Cream, 3.6% 1 Topically administered Sildenafil Cream 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 resu
Slide 22: Oral Viagra studies in women
Sildenafil Cream, 3.6% Statistically significant increases in Statistically significant improvement Vaginal Pulse Amplitude (VPA)1 in 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 23: Phase 1 and 2a Studies of Sildenafil Cream
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 24: 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 25: 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 26: Vaginal Drug Delivery
Vaginal Drug Delivery New prescription drug delivery options for women
Slide 27: 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 28: DARE-HRT1 combination hormone 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) Ongoing Phase 1 VMS/HRT STUDY HRT remains the most effective treatment for vasomotor symptoms (VMS) A Phase 1, Ope
Slide 29: 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) 2 After steadily declining from 2007 to 2014, the premature birth rate in the United States rose for the fourth straight y
Slide 30: DARE-VVA1 vaginal tamoxifen
Vaginal Drug Delivery Technology 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
Slide 31: Vaginal tamoxifen exploratory study
Vaginal Drug Delivery Technology 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 vaginal d
Slide 32: UC-LARC / Microchips Technology
User-Controlled Long Acting Reversible Contraception (UC-LARC) / Microchips Technology
Slide 33: DARE-LARC1 User-Controlled Long Acting Reversible Contraception
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 34: 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 35: Daré Financial Summary
Daré Financial Summary Q2-2020 Financial Highlights: • Net cash provided from financing activities* through 6/30/20: $11.0 million (net) • Cash and equivalents (as of 6/30/2020): $5.3 million Updates from July 1 through August 11, 2020: • Net cash provided by sales of stock and warrant exercises: $3
Slide 36: Daré Non-Dilutive Funding Sources
Daré Non-Dilutive Funding Sources Grant funding: • $1.9 million grant for Ovaprene R&D expenses from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a division of the National Institutes of Health (NIH). • Eunice Kennedy Shriver National Institute of Chil
Slide 37: Management Team & Board of Directors
Management Team & Board of Directors 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
Slide 38: Daring to be Different and advancing products women want
DARING TO BE DIFFERENT™AND ADVANCING PRODUCTS WOMEN WANT NASDAQ: DARE www.darebioscience.com
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