Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (April 2021)
48 slides from Dare Bioscience's investor presentation, Apr 8, 2021
Slide 1: User-Controlled Long-Acting Reversible Contraception Corporate Presentation
User-Controlled Long-Acting Reversible Contraception ©2021 Daré Bioscience | All rights reserved NASDAQ: DARE www.darebioscience.com Corporate Presentation: April 8, 2021 Daré Bioscience Exhibit 99.1
Slide 2: Forward-Looking Statements; Disclaimers
Forward-Looking Statements; Disclaimers 2 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 ST
Slide 3: Daré Bioscience - A Compelling Opportunity
Daré Bioscience - A Compelling Opportunity 3 Daré Bioscience is a clinical-stage biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that expand trea
Slide 4: Women's Health Is Our Sole Focus
Women’s Health Is Our Sole Focus 4 Working to accelerate innovative product options in women’s health by… • Identifying and advancing new therapies that provide additional choices • Enhancing outcomes • Improving ease of use We look for… • Differentiated investigational products with attractive mark
Slide 5: Partnering with Industry Leaders
Partnering with Industry Leaders 5 * We partner to… Drive innovation and develop new solutions Accelerate novel products to address persistent unmet needs Become a pipeline resource for large and emerging commercial companies We partner with…
Slide 6: Advancing Products Women Want
Advancing Products Women Want 6 Potential First-line Option for Bacterial Vaginosis Bioadhesive gel, clindamycin 2% First-in-category Hormone-Free Monthly Contraception Self-administered intravaginal drug/device DARE-BV1^ Bacterial Vaginosis- Phase 3 Topline Data Announced December 2020 Ovaprene® Ho
Slide 7: Upcoming Milestones
Upcoming Milestones Near Term Catalysts to Drive Value 7 DARE-BV1^ Bacterial Vaginosis Phase 3 Complete Sildenafil Cream, 3.6%^ FSAD Phase 2b Topline Data Ovaprene® Contraception Pivotal Study 6-month Data 2020 2021 2022 DARE-HRT1^‡ Hormone Therapy Phase 1 Topline Data Planned NDA Submission & FDA R
Slide 8: Experienced Management & Board of Directors
Experienced Management & Board of Directors 8 Board of Directors William Rastetter, PhD Chairman Cheryl Blanchard, PhD Jessica Grossman, MD Susan Kelley, MD Greg Matz, CPA Robin Steele, JD, LLM Sabrina Martucci Johnson MSc, MIM President & CEO Management Team Sabrina Martucci Johnson MSc, MIM Presid
Slide 9: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis Best-in-class curative potential for the most common1 vaginal infection in women of reproductive age, designed for convenient, one-time administration Planned NDA submission 2Q 2021 91. https://www.cdc.gov/std/bv/stats.htm
Slide 10: Bacterial Vaginosis - What Is the clinical issue?
Bacterial Vaginosis - What Is the clinical issue? Recurring infection, difficult to treat effectively • Most common vaginal infection in women ages 15-44, affecting ~21 million women in the US1 • Current Rx suboptimal: clinical cure rates of 37-68% 2 Bacterial Vaginosis increases health risk3 • Pret
Slide 11: DARE-BV1: Potential for Improved Clinical Cure Rates vs. Current Branded Rx
DARE-BV1: Potential for Improved Clinical Cure Rates vs. Current Branded Rx 11 Product Frequency, Dose, and Route of Administration Study Descriptions Clinical Cure Rates Randomized Placebo-Controlled Phase 3 Trial 1 Topline data DARE-BV1 (Investigational) 1 time, 5g applicator, applied vaginally DA
Slide 12: DARE-BV1 QIDP and Fast Track Designations: Looking Forward
DARE-BV1 Qualified Infectious Disease Product (QIDP) and Fast Track Designations DARE-BV1: Looking Forward DARE-BV1 delivered better clinical cure rate values than currently marketed FDA-approved products for treatment of bacterial vaginosis.1 DARE-BVFREE Study: • 70% at Day 21-30 (primary endpoint)
Slide 13: Sildenafil Cream, 3.6%
Sildenafil Cream, 3.6% Potential First-In-Category treatment for Female Sexual Arousal Disorder (FSAD), which has no FDA-approved therapies Novel cream formulation of sildenafil to treat FSAD, utilizing active ingredient in Viagra® 13
Slide 14: FSAD – The Clinical Issue
FSAD – The Clinical Issue Female Sexual Arousal Disorder (FSAD) is characterized primarily by inability to attain or maintain sufficient genital arousal during sexual activity and, of female sexual function disorders, is most analogous to erectile dysfunction (ED) in men.* The condition should be di
Slide 15: FSAD – What Is the Incidence?
FSAD – What Is the Incidence? 15 Meta-analysis of 95 studies from 2000-2014 indicated prevalence of Female Sexual Dysfunction in premenopausal women worldwide is 41%, and difficulty with arousal alone is 23%.1 Market research estimates: • 33% of US women aged 21 to 60 (~ 20 million women), experienc
Slide 16: There are no FDA-approved treatments for FSAD
There are no FDA-approved treatments for FSAD 1. Sildenafil Cream, 3.6%, (formerly SST-6007) 2. https://qz.com/quartzy/1238783/its-the-20th-anniversary-of-viagra-heres-how-its-changed-the-world/#:~:text=Annual%20sales%20of%20Viagra%20peaked,Viagra%20is%20set%20to%20expire . Sildenafil Cream, 3.6% -
Slide 17: Sildenafil Cream, 3.6% - Phase 2b
17 Sildenafil Cream, 3.6% - Phase 2b Ongoing Phase 2b clinical study aims to evaluate Sildenafil Cream vs. placebo over 12 weeks of dosing following both a non-drug and placebo run-in period. • Compares Sildenafil Cream vs. placebo used in patients’ home setting. • Primary endpoint: patient reported
Slide 18: Ovaprene
Ovaprene® Investigational potential first-in-category, hormone- free, monthly birth control Partnered with 18
Slide 19: Bayer licensing agreement terms
19 • Bayer received the right to obtain exclusive US rights to commercialize the product, following completion of the pivotal clinical trial if Bayer, in its sole discretion, pays Daré $20 million. • Daré may receive up to $310 million in commercial milestone payments, plus double- digit, tiered roy
Slide 20: Contraception: Large Market Opportunity
Contraception: Large Market Opportunity 201. https://www.bayer.com/en/bayer-ag-annual-report-2019.pdfx. Includes sales for Mirena®, Kyleena® and Jaydess® / Skyla® 2. https://www.prnewswire.com/news-releases/allergan-reports-fourth-quarter-and-full-year-2019-financial-results-301001646.html 3. https:
Slide 21: Ovaprene - Potential Market Opportunity
Ovaprene® - Potential Market Opportunity 1. Source: CDC National Survey for Family Growth,2013-2015 dataset, cdc.gov. 2. Market research study conducted in 2019 for Daré Bioscience 3. Contraceptive use data applied to 2019 population data from US Census There are approximately 65 million women in th
Slide 22: Contraception: What's Missing from Current Hormone-Free Options?
Contraception: What’s Missing from Current Hormone-Free Options? 22 Most Effective Pregnancies Expected (per 100 women) 1,* >27 18 12 <1 Spermicides & Vaginal Gels Condoms (male) Diaphragms (with a spermicide) Copper IUD 2 * Pregnancy rates tell you the number of pregnancies expected per 100 women d
Slide 23: Ovaprene Investigational Hormone-Free, Monthly Contraceptive
Ovaprene® Investigational Hormone-Free, Monthly Contraceptive 23 1. https://www.urban.org/urban-wire/women-want-effective-birth-control 2. Lessard, L,Perspectives on Sexual and Reproductive Health, Volume 44, Number 3,9-2012 3. Hooper, DJ, Clin Drug Investig. 2010;30(11):74963 4. Ersek, J, Matern Ch
Slide 24: Early-Stage Portfolio
Early-Stage Portfolio Innovative prescription drug delivery programs DARE-HRT1 DARE-FRT1 DARE-VVA1 DARE-LARC1 DARE-RH1 ORB 204 & 214 24
Slide 25: Advancing Products Women Want
Advancing Products Women Want 25 PARTNERS Product Candidate PRE-CLINICAL PHASE 1 PHASE 2 First-in-category hormone-free vaginal treatment for VVA in a hormone-receptor positive, breast cancer patient population. Proprietary formulation of tamoxifen for vaginal administration. DARE-HRT1^‡ Hormone The
Slide 26: Summary of pipeline and milestones
• Innovative women’s health pipeline with multiple clinical, regulatory and commercial milestones anticipated in 2021-2022. • Every program, if approved, represents a potential first-line or first-in-class product opportunity. • Experienced Board of Directors and Management Team with demonstrated su
Slide 27: Appendix
NASDAQ: DARE www.darebioscience.com DARING TO BE DIFFERENT® AND ADVANCING PRODUCTS WOMEN WANT Appendix 27
Slide 28: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
Slide 29: DARE-BV1 Phase 3 Study Design & Demographics
N=307 subjects enrolled (age 15 and above) Duration ~30 days per subject Diagnosis - Bacterial vaginosis Definitions: Primary Endpoint: Clinical Cure (Day 21-30 visit): Resolution of the abnormal vaginal discharge associated with BV; Negative 10% KOH “whiff test”; Clue cells < 20% of the total epith
Slide 30: DARE-BVFREE Phase 3 Study results
• The study’s primary endpoint was clinical cure of bacterial vaginosis determined at Day 21- 30 visit in the modified intent-to-treat (mITT) study population (N=180). 1 • The study met its primary endpoint, demonstrating single administration of DARE-BV1 proved statistically superior to placebo (p-
Slide 31: Investigational Hormone-Free, Monthly Contraceptive
Investigational Hormone-Free, Monthly Contraceptive The U.S. contraceptive market size is projected to reach USD 9.6 billion by 2027 expanding at a CAGR of ~4.2% ~37 million U.S. women of reproductive age are estimated to currently use a contraceptive method 1. Grand View Research report, Feb 2020,
Slide 32: Ovaprene regulatory pathway and pivotal study
1. Anticipated regulatory pathway and timelines. 2. In PCT studies of similar size, products (diaphragms) that demonstrated no motile sperm in the cervical mucus during PCT assessments later demonstrated “typical use” contraceptive effectiveness of 86-91% in pivotal contraceptive studies evaluating
Slide 33: Female Sexual Arousal Disorder (FSAD)
1. https://www.businesswire.com/news/home/20190628005277/en/Global-Female-Sexual-Dysfunction-Treatment-Market-2019-2023 Female Sexual Arousal Disorder (FSAD) The global female sexual dysfunction treatment market is expected to grow at ~37% CAGR from 2019 - 2023 1 Sildenafil Cream, 3.6%
Slide 34: Mean and Maximum VPA; Improvement on FIEI Questions
0 1 2 3 4 5 6 7 Mean (Erotic) Maximum (Erotic) V a g in a l P ul se A m p lit ud e (m V ) Mean and Maximum VPA† Placebo Oral Viagra® † Twelve healthy premenopausal women were studied. P<0.05 P=0.093 0 10 20 30 40 50 60 70 Question 2 Question 4 O b se rv ed N um b er Im p ro ve d (% ) Improvement on
Slide 35: Sildenafil Cream, 3.6% - Phase 1/2a Study Results
Phase 1 Study of SST-6007 (Sildenafil Cream, 3.6%)1 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 oral sildenafil dose • AUC – 3-6% • Cm
Slide 36: Thermography Study Design & Methodology
Positive Data- (See Figure 1) • Positive cognitive arousal responses were noted. • Significantly greater increases in genital temperature after application of Sildenafil Cream compared to placebo cream and no cream. • Significantly greater self-reported arousal responses reported during Sildenafil C
Slide 37: Vaginal Drug Delivery
New investigational prescription drug delivery options for women Vaginal Drug Delivery
Slide 38: Intravaginal Ring Technology (IVR) Highlights
Intravaginal Ring Technology (IVR) Highlights The Vaginal Route of Drug Administration1 • Vaginal drug delivery offers many potential advantages due to large surface area, dense network of blood vessels and high elasticity due to presence of smooth muscle fibers. • Recognized advantages include comp
Slide 39: DARE-HRT1 Hormone Therapy
1. U.S. Census Bureau, Population Division. Table 2. 2015 to 2060 (NP2012-T2). Released Dec. 2012. 2. The 2017 hormone therapy position statement of The North American Menopause Society; Menopause: The Journal of The North American Menopause Society Vol. 24, No. 7, pp. 728-753, https://www.menopause
Slide 40: DARE-FRT1 Assisted Reproductive Technologies
DARE-FRT1 40 Assisted Reproductive Technologies (ART)/IVF As women wait longer to have children, infertility risk increases • ~12-15% of couples cannot conceive after 1-year of unprotected sex. • ~20% of US women have their first child after age 35; ~1/3 of couples in which the woman is older than 3
Slide 41: DARE-VVA1
DARE-VVA1 Potential to be the first therapeutic specifically approved for treatment of vulvar and vaginal atrophy (VVA) in patients with hormone-receptor positive (HR+) breast cancer. • Approximately 3.8 million US women have a history of breast cancer; HR+ is the most common type.2 • Localized estr
Slide 42: Exploratory study of vaginal tamoxifen in VVA
This exploratory study1 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 dryness. In addition, systemic ab
Slide 43: User-Controlled Long-Acting Reversible Contraception / Microchips Technology
(UC-LARC) / Microchips Technology User-Controlled Long-Acting Reversible Contraception
Slide 44: DARE-LARC1: Design Features of the Technology
DARE-LARC1: Design Features of the Technology User-Controlled Long-Acting Reversible Contraception • Drug Storage • Individual doses stored in micro-reservoir arrays • Reservoirs are hermetically sealed at room temperature • Thin membranes over each reservoir protect drug post-sealing • Drug Release
Slide 45: DARE-LARC1 Grant Funding
DARE-LARC1 Grant Funding 45 The Bill & Melinda Gates Foundation has strong interest in family planning ~215 million women in developing countries lack access to contraception Grant funding to date: $20.5m Grant to understand user needs and define the product conceptFunding 2013 Favorable response fr
Slide 46: Financial Summary
Financial Summary
Slide 47: Daré Financial Summary
FY 2020 Financial Highlights: • Cash provided from financing activities* through 12/31/20: $25.1 million (net of fees) • Cash and equivalents (as of 12/31/20): $4.7 million 1Q2021 Update (January 1 to March 29, 2021): • Cash provided by sales of common stock: $11.3M (net of fees) • Common shares o/s
Slide 48: www.darebioscience.com
NASDAQ: DARE www.darebioscience.com DARING TO BE DIFFERENT® AND ADVANCING PRODUCTS WOMEN WANT 48