Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (June 2021)
42 slides from Dare Bioscience's investor presentation, Jun 30, 2021
Slide 1: Corporate Presentation: June 30, 2021
Daré Bioscience DARÉ IN ITALIAN, IT MEANS “TO GIVE.” IN ENGLISH, IT MEANS “TO BE BOLD.” NASDAQ: DARE www.darebioscience.com Corporate Presentation: June 30, 2021 ©2021 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: Women's Health is Our Sole Focus
3 Women’s Health is Our Sole Focus 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
1 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 delivery platforms Persistent unmet needs require creative new approaches
Slide 5: Product candidate pipeline
5 PARTNERS Product Candidate PRE- CLINICAL PHASE 1 PHASE 2 PHASE 3 / PIVOTAL REGULATORY FILING DARE-BV1^ Bacterial Vaginosis- Phase 3 Topline Data Announced December 2020, NDA submitted 2Q2021 Novel, investigational thermosetting bioadhesive hydrogel single-administration vaginal treatment for bacte
Slide 6: Product candidate pipeline (continued)
6 DARE-HRT1^ Hormone Therapy - Phase 1 Study Complete DARE-FRT1^ Pregnancy Maintenance - Phase 1 Preparation DARE-VVA1^ Vulvar and Vaginal Atrophy – Phase 1 Preparation DARE-LARC1^ Long-Acting, Reversible Personal Contraceptive System ORB 204/214^ 6 & 12-Month Injectable Contraception ^505(b)(2) reg
Slide 7: Near Term Catalysts to Drive Value
Phase 1 Topline Data 7 Near Term Catalysts to Drive Value DARE-BV1 NDA submitted during 2Q2021 Potential PDUFA action by year end 2021* DARE-HRT1 Topline Phase 1 data reported 2Q2021 Sildenafil Cream, 3.6% Phase 2b commenced 1Q2021 Topline Phase 2b data targeted by year end 2021 Ovaprene IDE submiss
Slide 8: Women's health pipeline with multiple milestones and transactions
8 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 succe
Slide 9: Experienced Management & Board of Directors
9 Experienced Management & Board of Directors Sabrina Martucci Johnson MSc, MIM President & CEO John Fair Chief Strategy Officer Lisa Walters-Hoffert Chief Financial Officer David Friend, PhD Chief Scientific Officer Mary Jarosz, RPh, RAC, FTOPRA Global Head of Regulatory Affairs Mark Walters Vice P
Slide 10: DARE-BV1 Clindamycin 2% gel for Bacterial Vaginosis
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 NDA submitted 2Q 2021 1.https://www.cdc.g
Slide 11: Bacterial Vaginosis - What is the clinical issue?
11 1.https://www.cdc.gov/std/bv/stats.htm 2.Bacterial vaginosis product data: http://www.clindesse.com/pdf/PI.pdf; http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205223s000lbl.pdf; http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205223s000lbl.pdf 3.https://www.mayoclinic.org/disea
Slide 12: DARE-BV1 Phase 3 Study Design & Demographics
12 DARE-BV1- Phase 3 Study Design & Demographics1 DARE-BV1 is a thermosetting vaginal gel formulated with clindamycin phosphate 2%, a well-known and well-characterized antibiotic designed for prolonged, localized release. ➤DARE-BVFREE randomized 307 women at 32 centers across the US in a 2:1 ratio t
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 DARE-BV1 (Investigational) (clindamycin phosphate vaginal gel, 2%) 1 time, 5g applicator, applied vaginally DARE-BVFREE (Day 21-3
Slide 14: DARE-BV1: Looking Forward
14 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) and 76% at Day 7-14 in the mITT population, and rates of 78% at Day 21-30 and
Slide 15: Sildenafil Cream, 3.6%
15 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®
Slide 16: 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 distinguished from a general
Slide 17: FSAD – What Is the Incidence?
17 FSAD – What Is the Incidence? 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: Sildenafil Cream, 3.6% - Product Profile
18 Sildenafil Cream, 3.6% - Product Profile ➤A PDE5 inhibitor utilized in ED medications for men – ED product Viagra® peaked at $2.05 billion in sales in 2012.2 ➤Designed to increase local blood flow to provide improvement in genital arousal response. ➤Applied topically, avoiding hepatic first-pass
Slide 19: Sildenafil Cream, 3.6% - Phase 2b
19 Sildenafil Cream, 3.6% - Phase 2b ➤Compares Sildenafil Cream vs. placebo used in patients’ home setting. ➤Primary endpoint: patient reported outcome (PRO) instruments to measure improvement in localized genital sensations of arousal and reduction in FSAD related distress. ➤Several exploratory eff
Slide 20: Oral Sildenafil provided a compelling proof of concept for FSAD
20 Oral Sildenafil provided a compelling proof of concept for FSAD † Question #2 – “After taking study medication, the sensation/feeling in my genital (vaginal, labia, clitoris) area during intercourse or stimulation (foreplay) seemed to be: (a) more than before, (b) less than before, or (c) unchang
Slide 21: Sildenafil Cream Phase 1 and Phase 2a Study Results
21 Phase 1 Study 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 •
Slide 22: Sildenafil Cream, 3.6% - Thermography Study Results
22 Sildenafil Cream, 3.6% - Thermography Study Results 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-rep
Slide 23: Ovaprene®
23 Ovaprene® Investigational potential first-in- category, hormone-free, monthly birth control Partnered With
Slide 24: Ovaprene® - Commercial License Agreement with Bayer
24 Ovaprene® - Commercial License Agreement with Bayer1 January 2020 - Bayer, which markets the $1 billion Mirena contraceptive franchise, and Daré announced the execution of a license agreement under which Bayer may commercialize Ovaprene investigational contraceptive in the US once approved by FDA
Slide 25: Contraception: Large Market Opportunity
25 Contraception: Large Market Opportunity Women in the Reproductive Health & Contraception Market Segment (over 60 million women) Mirena® Hormone IUD (levonorgestrel-releasing intrauterine system) 52mg Physician inserted, long-acting. low/locally delivered hormone IUS 2019 worldwide sales: €1.2 bil
Slide 26: Ovaprene® - Potential Market Opportunity
26 Ovaprene® - Potential Market Opportunity There are approximately 65 million women in the US Aged 15-441 12 Million Current Non-Users 11 Million Current Hormone-free Product Users 12 Million Current Hormonal Product Users 35 Million Women2,3 Potential Candidates for Ovaprene •Pill (10.3M) •Injecta
Slide 27: Contraception: What's Missing from Current Hormone-Free Options?
27 Contraception: What’s Missing from Current Hormone-Free Options? Hormone-free Options Pregnancies Expected (per 100 women) 1,* Spermicides & Vaginal Gels 2 Condoms (male) Diaphragms (with a spermicide) Easy-to-use monthly option Copper IUD >27 18 12 Effectiveness approaching hormonal methods <1 L
Slide 28: Ovaprene® Investigational Hormone-Free, Monthly Contraceptive
28 Ovaprene® Investigational Hormone-Free, Monthly Contraceptive Spermiostatic Environment6 Contraceptive-loaded silicone ring releasing non-hormonal active Ferrous gluconate Physical Barrier 6 Three-dimensional, knitted polymer barrier 1.https://www.urban.org/urban-wire/women-want-effective-birth-c
Slide 29: Ovaprene® - U.S. Regulatory Strategy
29 Ovaprene® - U.S. Regulatory Strategy1 Step 1 (Completed) •Postcoital Test (PCT) Clinical Study - Completed 4Q 2019 Step 2 (Ongoing) 1 - File investigational device exemption (IDE) to support 1Q2022 pivotal study start. 2 - Conduct pivotal study • Six-month efficacy and safety data expected by yea
Slide 30: Milestones and Catalysts
30 Milestones and Catalysts
Slide 31: Near Term Catalysts to Drive Value
31 Near Term Catalysts to Drive Value 2019 and 2020 ✓ 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 Ovaprene ✓ May/Sept 20
Slide 32: Phase 1 and Preclinical Programs
32 Phase 1 and Preclinical Programs New investigational prescription drug delivery options for women
Slide 33: Phase 1 and Preclinical Programs pipeline
33 DARE-HRT1^ Hormone Therapy - Phase 1 Study Complete DARE-FRT1^ Pregnancy Maintenance - Phase 1 Preparation DARE-VVA1^ Vulvar and Vaginal Atrophy – Phase 1 Preparation DARE-LARC1^ Long-Acting, Reversible Personal Contraceptive System ORB 204/214^ 6 & 12-Month Injectable Contraception ^505(b)(2) re
Slide 34: Intravaginal Ring Technology (IVR) Highlights
34 Intravaginal Ring Technology (IVR) Highlights ➤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 comparable ease of administration and ability
Slide 35: DARE-HRT1 Hormone Therapy
35 DARE-HRT1 Combination bio-identical estradiol + bio-identical progesterone 28-day IVR for hormone therapy following menopause 45M women in U.S. approaching or in menopause1 Hormone Therapy (HT) HT remains the most effective treatment for vasomotor symptoms (VMS) and genitourinary syndrome of meno
Slide 36: DARE-FRT1 Pregnancy Maintenance
36 DARE-FRT1 Bio-identical progesterone 14-day IVR for prevention of preterm birth and luteal phase support as part of an IVF treatment plan Prevention of Preterm Birth (PTB) After steadily declining from 2007 to 2014, the US premature birth rate rose for the fourth straight year in 2018 with ~10% o
Slide 37: DARE-VVA1 Vulvar and Vaginal Atrophy
37 DARE-VVA1 Proprietary tamoxifen formulation for vaginal administration for vulvar and vaginal atrophy (VVA), a chronic condition characterized by pain during intercourse, vaginal dryness and irritation Potential to be the first therapeutic specifically approved for treatment of VVA in patients wi
Slide 38: DARE-VVA1 - Proof of Concept
38 Vaginal Tamoxifen Enrollment (Baseline) On Treatment (Month 3) Paired Difference (Baseline vs. Month 3) Median Vaginal pH Normal vaginal pH is usually less than 4.5.2 7.1 range 6.5 to 7.5 5.0 range 5.0 to 5.2 -2.0 median range -2.5 to -1.5 Lower pH value is a measure of symptom relief Vaginal Dry
Slide 39: DARE-LARC1 Funding
39 DARE-LARC1 Funding 2013 Funding 2014-2021 User-Controlled Long-Acting Reversible Personal Contraceptive System – levonorgestrel implant drug delivery system is designed to store and precisely deliver hundreds of therapeutic doses over months or years in a single implant that can be wirelessly con
Slide 40: Financial Summary
40 Financial Summary
Slide 41: Daré Financial Summary
41 Funding sources: •Since inception, we have raised cash through sale of equity securities, M&A transactions, warrant and option exercises, non-dilutive grants, and license fees •We endeavor to be creative and opportunistic in seeking capital required to advance our candidates, and to be efficient
Slide 42: Daring to Be Different and Advancing Products Women Want
42 DARING TO BE DIFFERENT® AND ADVANCING PRODUCTS WOMEN WANT NASDAQ: DARE www.darebioscience.com DARE TO BE BOLD