Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (December 2020)
40 slides from Dare Bioscience's investor presentation, Dec 9, 2020
Slide 1: Daré Bioscience December 9, 2020
December 9, 2020©2020 Daré Bioscience | All rights reserved 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: Partnering is core to our strategy
3 Partnering is core to our strategy We look for… Highly differentiated products with attractive market opportunities Proof-of-concept and/or the ability to leverage a 505(b)(2) regulatory pathway First-in-category or first-line opportunities Personalized for women (non-systemic delivery) We partner
Slide 4: Product candidate overview
First-in-category Hormone-Free Vaginal Treatment for VVA Proprietary formulation of tamoxifen for vaginal administration Timeline reflects management’s current estimates and constitutes a forward-looking statement subject to qualifications noted elsewhere in this presentation. Actual development tim
Slide 5: Development timeline 2020-2022
Timeline reflects management’s current estimates and constitutes a forward-looking statement subject to qualifications noted elsewhere in this presentation. Actual development timelines may be substantially longer, and Daré is under no obligation to update or review these estimates. ^505(b)(2) regul
Slide 6: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
Slide 7: 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 8: 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 9: DARE-BVFREE Phase 3 Study results
• The primary endpoint for the study was clinical cure of bacterial vaginosis determined at the Day 21-30 visit in the modified intent-to-treat (mITT) study population (N=180) 1. • The study met its primary endpoint demonstrating that a single administration of DARE-BV1 proved statistically superior
Slide 10: DARE-BV1 Branded Rx Comparison
DARE-BV1(Branded Rx Comparison) 10 1. Data on file 2. SOLOSEC PRESCRIBING INFORMATION https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=551e43d5-f700-4d6e-8029-026f8a8932ff&type=display 3. Clindesse PRESCRIBING INFORMATION https://www.clindesse.com/pdf/PI.pdf 4. Nuvessa PRESCRIBING INFO
Slide 11: DARE-BV1 QIDP and Fast Track Designation
• Daré expects to have a pre-NDA meeting with the FDA in early 2021 and to submit an NDA during the first half of 2021. • DARE-BV1 received both Fast Track and Qualified Infectious Disease Product designations from the FDA for the treatment of bacterial vaginosis. Given these designations, the NDA m
Slide 12: Ovaprene 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 13: Contraception: what kinds of products are successful?
Contraception: what kinds of products are successful? 13 Mirena 1. 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-30
Slide 14: Contraception: what features are women seeking?
1. Hooper, DJ, Clin Drug Investig. 2010;30(11):74963 2. Lessard, L,Perspectives on Sexual and Reproductive Health, Volume 44, Number 3,9-2012 3. https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states Contraception: what features are women seeking? Effectiveness (pregnancy prevention)
Slide 15: Contraception: what products are hormone-free?
1. U.S. Food and Drug Administration Birth Control Guide: https://www.fda.gov/consumers/free-publications-women/birth-control-chart 2. U.S. Food and Drug Administration Drug Data Prescribing information for a recently approved vaginal gel, Phexxi™ provides that in a multicenter, open-label, single-a
Slide 16: Contraception: what's missing from hormone-free options?
16 Most Effective Number of pregnancies expected (per 100 women) * >27 (greater than 27 pregnancies) 18 12 <1 (less than 1 pregnancy) Spermicides & Vaginal Gels Condoms (male) Diaphragms (with a spermicide) Copper IUD 2 * The pregnancy rates tell you the number of pregnancies expected per 100 women
Slide 17: Ovaprene Investigational Hormone-Free, Monthly Contraceptive
Ovaprene® Investigational Hormone-Free, Monthly Contraceptive 17 Spermiostatic Environment 6 Contraceptive-loaded silicone ring releasing non-hormonal active Ferrous gluconate Physical Barrier 6 Three-dimensional, knitted polymer barrier Desired Features of Birth Control Products:1-4 Design Features
Slide 18: Ovaprene U.S. Regulatory Strategy
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 19: Ovaprene Commercial License Agreement with Bayer
Ovaprene Commercial License Agreement with Bayer 1 19 • Bayer received the right to obtain exclusive rights to commercialize the product in the U.S. following completion of the pivotal clinical trial if Bayer, in its sole discretion, makes payment to Daré of $20 million. • Daré may receive up to $31
Slide 20: Female Sexual Arousal Disorder market
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 21: 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 most analogous to erectile dysfunction
Slide 22: 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 Market research estimates: • 33% of women in the U.S. age 21 to 60 (approximately 20 mi
Slide 23: Sildenafil Cream, 3.6%
1. Sildenafil Cream, 3.6%, (formerly SST-6007) Sildenafil Cream, 3.6% 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, avoidin
Slide 24: Oral Viagra data in women (VPA and FIEI)
0 1 2 3 4 5 6 7 Mean (Erotic) Maximum (Erotic) V a g in a l P u ls e A m p li tu d 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 s e rv e d N u m b e r Im p ro v e d (% ) Improve
Slide 25: Phase 1 and 2a Studies of Sildenafil Cream
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 26: Positive Data – Thermography Study
Positive Data – Thermography Study* Positive findings for Sildenafil Cream, 3.6% (as shown in 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. • Signifi
Slide 27: Phase 2b – At Home Study
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. • Primary endpoint patient r
Slide 28: Vaginal Drug Delivery
New investigational prescription drug delivery options for women Vaginal Drug Delivery
Slide 29: Vaginal Drug Delivery Technology - IVR
Vaginal Drug Delivery Technology - IVR The Vaginal Route of Drug Administration 1 • 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: comp
Slide 30: IVR: Hormone Replacement Therapy (HRT)
1. Anticipated regulatory pathway. Daré has not had any communications with the FDA regarding the specific marketing approval requirements for DARE-HRT1 or DARE-FRT1 2. The 2017 hormone therapy position statement of The North American Menopause Society; Menopause: The Journal of The North American M
Slide 31: IVR: Assisted Reproductive Technologies (ART)/IVF
Vaginal Drug Delivery Technology - IVR 31 Assisted Reproductive Technologies (ART)/IVF As women wait longer to have children, they increase their risk of infertility. • An estimated 12-15% of couples are unable to conceive after 1-year of unprotected sex. • Approximately 20% of U.S. women have their
Slide 32: Vaginal Drug Delivery: VVA in HR+ breast cancer
Vaginal Drug Delivery Technology Potential to be the first treatment specifically approved for the treatment of vulvar and vaginal atrophy (VVA) in patients with hormone-receptor positive (HR+) breast cancer. • Approximately 3.8 million women in the U.S. have a history of breast cancer and HR+ is th
Slide 33: Exploratory study of vaginal tamoxifen in VVA
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 dryness. In addition, systemic abs
Slide 34: User-Controlled Long-Acting Reversible Contraception (UC-LARC) / Microchips Technology
(UC-LARC) / Microchips Technology User-Controlled Long-Acting Reversible Contraception
Slide 35: 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 36: DARE-LARC1 and Bill & Melinda Gates Foundation funding
DARE-LARC1 User-Controlled Long Acting Reversible Contraception 36 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. Grant funding to date: $20.5m Grant to understand user needs and
Slide 37: Daré Financial Summary
Q3-2020 Financial Highlights: • Cash provided from financing activities* through 9/30/20: $16.7 million (net) • Cash and equivalents (as of 9/30/20): $5.4 million Updates from October 1 through November 11, 2020: • Cash provided by sales of stock: $4.5 million (net) • Common shares o/s: ~ 38 million
Slide 38: Grant funding
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 Child Health and Human Development (NI
Slide 39: Management Team & Board of Directors
WE ARE DELIVERING INNOVATION BY DARING TO BE DIFFERENT® Management Team & Board of Directors 39 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 MANAGE
Slide 40: www.darebioscience.com
NASDAQ: DARE www.darebioscience.com DARING TO BE DIFFERENT ™ AND ADVANCING PRODUCTS WOMEN WANT
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