Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (May 2021)
42 slides from Dare Bioscience's investor presentation, May 17, 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: May 17, 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: Women's Health is Our Sole Focus
Women’s Health is Our Sole Focus 3 Daré Bioscience is a clinical-stage biopharmaceutical company committed to addressing the lack of innovation in women’s health primarily in the areas of contraception, vaginal health, sexual health, and fertility. We work to accelerate innovative product options in
Slide 4: Daré Bioscience – A Compelling Opportunity
Daré Bioscience – A Compelling Opportunity 4 Company Highlights Diverse pipeline with independent outcomes – Several programs including an NDA stage and four clinical development stage or Phase 1-ready candidates utilizing different APIs and targeting different indications Multiple novel deliver
Slide 5: Advancing Products Women Want – Late Stage Programs
Advancing Products Women Want – Late Stage Programs 5 Potential first-line option for bacterial vaginosis Bioadhesive gel, clindamycin 2% Potential first-in-category contraception Self-administered intravaginal drug/device DARE-BV1^ Bacterial Vaginosis- Phase 3 Topline Data Announced December 2020,
Slide 6: Advancing Products Women Want – Phase 1 and Preclinical
Advancing Products Women Want – Phase 1 and Preclinical 6 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
Slide 7: Upcoming Milestones: Near Term Catalysts to Drive Value
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: Innovative women's health pipeline with multiple 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 9: Experienced Management & Board of Directors
Experienced Management & Board of Directors 9 Board of Directors William Rastetter, PhD Chairman Cheryl Blanchard, PhD Jessica Grossman, MD Susan Kelley, MD Greg Matz, CPA Sophia N. Ononye-Onyia, PhD, MPH, MBA Robin Steele, JD, LLM Sabrina Martucci Johnson MSc, MIM President & CEO Management Team Sa
Slide 10: 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 101. https://www.cdc.gov/std/bv/stats.htm
Slide 11: 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 12: 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 13: DARE-BV1: Potential for Improved Clinical Cure Rates vs. Current Branded Rx
DARE-BV1: Potential for Improved Clinical Cure Rates vs. Current Branded Rx 13 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 14: 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: • 71% at Day 21-30 (primary endpoint)
Slide 15: 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® 15
Slide 16: 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 17: FSAD – What Is the Incidence?
FSAD – What Is the Incidence? 17 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 18: 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 19: Sildenafil Cream, 3.6% - Phase 2b Ongoing
19 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 20: 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 21: 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 22: Thermography Study Design & Methodology
Demonstrated time to effect (See Figure 1) • Positive cognitive arousal responses were noted. • Significantly greater increases in genital temperature after application of Sildenafil Cream compared to placebo cream. • Significantly greater self-reported arousal responses reported during Sildenafil C
Slide 23: Ovaprene®: Hormone-Free, Monthly Birth Control
Ovaprene® Investigational potential first-in-category, hormone- free, monthly birth control Partnered with 23
Slide 24: Bayer License Agreement for Ovaprene
24 • 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 25: Contraception: Large Market Opportunity
Contraception: Large Market Opportunity 251. 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 26: 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 27: Contraception: What's Missing from Current Hormone-Free Options?
Contraception: What’s Missing from Current Hormone-Free Options? 27 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 28: Ovaprene® Investigational Hormone-Free, Monthly Contraceptive
Ovaprene® Investigational Hormone-Free, Monthly Contraceptive 28 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 29: Ovaprene Premarket approval (PMA) strategy
1. Anticipated regulatory pathway and timelines. 2. Mauck C, Vincent K. Biology of Reproduction, Volume 103, Issue 2, August 2020, Pages 437–444 • Postcoital Test (PCT) Study - Completed 4Q 2019 29 Premarket approval (PMA) strategy The Center for Devices and Radiological Health (CDRH) as lead review
Slide 30: Anticipated Milestones and Catalysts
Anticipated Milestones and Catalysts
Slide 31: Near Term Catalysts to Drive Value
Near Term Catalysts to Drive Value 2019 and 2020 Data and Alliances • June 2019 – Positive findings of Sildenafil Cream, 3.6% thermography clinical study • Nov. 2019 – Positive topline data for Ovaprene® postcoital test clinical study • Jan. 2020 – Exclusive licensing agreement with Bayer for Ovapre
Slide 32: Phase 1 and Preclinical Programs
New investigational prescription drug delivery options for women Phase 1 and Preclinical Programs
Slide 33: Advancing Products Women Want – Phase 1 and Preclinical
Advancing Products Women Want – Phase 1 and Preclinical 33 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 administratio
Slide 34: 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 35: 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 36: DARE-FRT1 Assisted Reproductive Technologies/IVF
DARE-FRT1 36 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 37: DARE-VVA1
DARE-VVA1 Potential to be the first therapeutic specifically approved for treatment of 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 estrogen therapy for VVA may be c
Slide 38: 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 39: DARE-LARC1 User-Controlled Long-Acting Reversible Contraception
DARE-LARC1 User-Controlled Long-Acting Reversible Contraception – levonorgestrel implant drug delivery technology is designed to store and precisely deliver hundreds of therapeutic doses over months or years in a single implant that can be wirelessly controlled. 39505(b)(2) candidate 1 1. Anticipate
Slide 40: Financial Summary
Financial Summary
Slide 41: 1Q-2021 Financial Highlights
1Q-2021 Financial Highlights: • Cash provided from financing activities: $11.4 million (net of fees) • Cash and equivalents (at 3/31/2021): $7.7 million April 1 through May 10, 2021 Update: • Cash provided from financing activities: $2.6 million (net of fees) • Common shares o/s: ~ 49.4 million shar
Slide 42: www.darebioscience.com
NASDAQ: DARE www.darebioscience.com DARING TO BE DIFFERENT® AND ADVANCING PRODUCTS WOMEN WANT 42