Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (January 2023)
54 slides from Dare Bioscience's investor presentation, Jan 9, 2023
Slide 1: Corporate Presentation: January 9, 2023
Dare Bioscience — G. DARE ; IN ITALIAN, IT MEANS “TO GIVE.” IN ENGLISH, IT MEANS “TO BE BOLD.” NASDAQ: DARE www.darebioscience.com Corporate Presentation: January 9, 2023 ©2023 Daré Bioscience | All rights reserved
Slide 2: Forward-Looking Statements; Disclaimers
ei) Forward-Looking Statements; Disclaimers eesianeomesnaenes TTT ETEETTELL EET EHH ee ee oe rk ee oe ee 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 presen
Slide 3: Health is Our Sole Focus
Health is Our Sole Focus Daré Bioscience is a biopharmaceutical company committed to addressing the lack of innovation in women’s health with differentiated products that address unmet needs primarily in the areas of contraception, fertility, vaginal, and reproductive, menopause, and sexual health.
Slide 4: Women's Health — An Efficient Investment Thesis
Health — An Efficient Investment Thesis We believe investment in women’s health Approximately 1% of healthcare research is will be efficient and invested in female-specific conditions disproportionately impactful: beyond oncology.* - Women’s Health products make up 27% of total blockbuster products
Slide 5: Women's Health — Compelling Markets Where Innovation Matters
Women’s Health — Compelling Markets Where Innovation Matters Contraception Vaginal Health ~73 million women ages 15-497 - Bacterial vaginosis affects ~21 million women in the US; as hormonal monthly IVR, NuvaRing, ~$900M at peak? but current Rx clinical cure rates 37-68%5 as hormonal IUD, Mirena fra
Slide 6: Daré Portfolio — The Big Ideas
Daré Portfolio — The Big Ideas* Contraception Ovaprene © - 1 Hormone-free, Monthly Contraceptive ADARE-204/214 - 15* 6 & 12-Month Injectable Contraceptive DARE-LARCa: - 1 Long-Acting, Reversible Personal Contraceptive System (grant funded program) DARE-RHa - Hormone-free contraceptive target for wom
Slide 7: Daré Bioscience: A Compelling Opportunity
Daré Bioscience: A Compelling Opportunity Upcoming Program Milestones* Meaningful market potential for differentiated products First-line or first-in-category product opportunities across the portfolio Diverse pipeline with independent outcomes One FDA-approved product and several clinical developme
Slide 8: Advancing Products Women Want - The Portfolio Snapshot
Advancing Products Women Want - The Portfolio Snapshot d doré PHASE 3/ REGULATORY FDA PRE-CIINICAL BHnee PHASE PIVOTAL SUBMISSION APPROVED XACIATO™ -* ORGANON NDA Approved Dec. 7, 2028 Sildenafil Cream, 3.6%" Female Sexual Arousal Disorder Phase 2b Study Completed Screening October 2022 DARE-HRT2" H
Slide 9: FDA Approved — XACIATO
FDA Approved — XACIATO XACIATO™ (Clindamycin Phosphate) Vaginal Gel, 2% NDA approved December 7, 2021 QIDP, Fast Track and Priority Review Designations Commercialization Collaborator -i# ORGANON * XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicat
Slide 10: Advancing Products Women Want - Late Stage Programs
Advancing Products Women Want - Late Stage Programs Ovaprene® Potential first-in-category hormone- Hormone-Free, Monthly Contraception : free contraception Pivotal Phase 3 Study to Commence 2023* a . . Self-administered intravaginal * Investigational hormone-free, monthly intravaginal contraceptive.
Slide 11: Advancing Products Women Want - Phase 1 and Preclinical
Advancing Products Women Want - Phase 1 and Preclinical Pregnancy Maintenance Phase a Study Preparation 1. First-in-category progesterone delivery for pregnancy maintenance including the prevention of preterm birth (DARE-PTBa) and for luteal phase support as part of an IVF regimen (DARE-FRTa). 2. IV
Slide 12: Daré: Advancing Products Women Want
Daré: Advancing Products Women Want Innovative women’s Every program, if Experienced Board of Directors wanieitsiiealth health pipeline with approved, represents and Management Team with eneratin i i ial fi i demonstrated success in clinical g gmere multiple upcoming a potential first-line or intere
Slide 13: Experienced Management & Board of Directors
Experienced Management & Board of Directors Management Team Board of Directors Zz BE Sabri rtucci Johi rabrina Ma RISEN William Rastetter, PhD = Chairman President & CEO John Fair Cheryl Blanchard, PhD Chief Strategy Officer Lisa Walters-Hoffert Chief Financial Officer Jessica Grossman, MD David Fri
Slide 14: Daré Financial Highlights
Daré Financial Highlights 3Q-2022 Snapshot: + Cash and equivalents 9/30/22: $40.4 M + Common shares o/s (11/9/22): 84.8 M + Warrants o/s: 1.4 M Funding sources: [Nori Cash received: > 30-2022 : ~$18.0M + Upfront license fee from Organon $10.0 M + Existing grant for DARE-LARC1: ~$8.0 M October 2022 +
Slide 15: Daré — Working to Accelerate Innovation in Women's Health
Daré —- Working to Accelerate Innovation in Women’s Health 7 Upcoming Program Milestones*: Ovaprene® (hormone-free monthly contraception) Pivotal Phase 3 study recruitment initiation mid-2023 XACIATO™ (clindamycin phosphate) vaginal gel, 2% + First commercial sale in 1H 2023 in the U.S. Sildenafil C
Slide 16: Commercialization Collaborator
Commercialization Collaborator:
Slide 17: Bacterial Vaginosis
Bacterial Vaginosis vr y ( { * Recurring infection, difficult to treat effectively » * Most common vaginal condition in women ages 15-44 _ * — Affects ~21 million women in the US? Clinical Issue ‘ rare ‘ ' a ' ' + Bacterial Vaginosis increases health risks?, including increased risk of preterm birth
Slide 18: XACIATO: Overview
XACIATO: Overview >» XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. > This marks the first FDA-approved product in Daré’s portfolio of potential QIDP, Fas
Slide 19: XACIATO - Commercial License Agreement with Organon
XACIATO - Commercial License Agreement with Organon? March 2022 — Organon and Daré announced they entered into an /— agreement whereby Organon will license * The license became effective June 2022. global rights to XACIATO. The license : ¢ Daré received a $10 million upfront payment from Organon bec
Slide 20: XACIATO Important Safety Information
XACIATO Important Safety Information* Indication XACIATO (clindamycin phosphate) vaginal gel is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. Dosage & Administer one applicatorful (5 g of gel containing 100 mg of clindamy
Slide 21: XACIATO Use in Special Populations
XACIATO Use in Special Populations* . + Other clindamycin vaginal products have been used to treat pregnant women during the second and Special third trimester. XACIATO has not been studied in pregnant women. However, based on the low Populations systemic absorption of XACIATO following the intravag
Slide 22: U.S. Commercialization Collaborator / Phase 3 Development Collaborator
" U.S. Commercialization Collaborator: (z** Phase 3 Development Collaborator:
Slide 23: Contraception: Large Market Opportunity
Contraception: Large Market Opportunity Women in the Reproductive Health & Successful Contraceptive Brands Peak Sales: Contraception Market Segment (over 60 million women) ‘Yeo Source: US Census Bureau, 2027 National Dataset (2036 is base population estimate for projection) https://www.census.govipr
Slide 24: Ovaprene Potential Market Opportunity
Ovap Potential Market Opportunity There are approximately 65 million women in the US Aged 15-447 30 Million Women? Not candidates for Ovaprene® Pty Currently use no el (20.3M) *Sterilization (10.5M) eInjectable (1.5M) Pregnant/postpartum/ seeking contraception *Vaginal Ring pregnancy (5.6M) Sexually
Slide 25: Contraception: What's Missing from Current Hormone-Free Options?
Contraception: What's Missing from Current Hormone-Free Options? Pregnancies Expected Hormone-free Options * (per 100 women) * Least Effective Spermicides >27 & Vaginal Gels? Condoms (male) 18 Diaphragms (with a spermicide) 2 Easy-to-use monthly Effectiveness approaching option hormonal methods Copp
Slide 26: Ovaprene Investigational Hormone-Free, Monthly Contraceptive
Ovaprene® Investigational Hormone-Free, Monthly Contraceptive Physical Barrier © Three-dimensional, knitted polymer barrier Spermiostatic Environment® Contraceptive-loaded silicone ring releasing non-hormonal active Ferrous gluconate Perspect ‘3Hooper, DJ, Clin Drug in Desired Features of Birth Cont
Slide 27: Ovaprene - Commercial License Agreement with Bayer
Ovaprene® - Commercial License Agreement with Bayer* January 2020 - Bayer, which markets the /caayer received the right to obtain exclusive US rights to $2 billion Mirena contraceptive franchise, commercialize the product, following completion of the and Daré announced the execution of a pivotal cli
Slide 28: Ovaprene - Collaborative Research Agreement with NIH
Ovaprene® - Collaborative Research Agreement with NIH? July 2021 — Daré announced that funding and ( -_ : + The pivotal Phase 3 study will be supported by the NICHD’s GliniGaloperaticis support ipr re races Contraceptive Development Program which oversees the Contraceptive Clinical Trial Network (CC
Slide 29: Ovaprene - U.S. Regulatory Strategy
Ovaprene® - U.S. Regulatory Strategy* Premarket approval (PMA) strategy — The Center for Devices and Radiological Health (CDRH) as lead review division Step 1 (Completed) Postcoital Test (PCT) Clinical Study - Completed 40 2019 Step 2 (Ongoing) a- FDA approval of investigational device exemption (ID
Slide 30: Potential First-In-Category Treatment for Female Sexual Arousal Disorder
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® 30
Slide 31: FSAD - The Clinical Issue
FSAD - The Clinical Issue Female Sexual Arousal Disorder (FSAD) is characterized The condition should be distinguished primarily by inability to attain or maintain sufficient genital from a general loss of interest in sexual arousal during sexual activity and, of female sexual function activity and
Slide 32: FSAD — What is the incidence?
FSAD — What is the incidence? Va 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%.* y, \ Market research estimates: > 33% of US women aged 21 to 60 (~ 20 million women), expe
Slide 33: Sildenafil Cream, 3.6% - Product Profile
Sildenafil Cream, 3.6% - Product Profile Topically administered investigational Sildenafil Cream?is... >A PDEs inhibitor utilized in ED medications for men — ED product Viagra® peaked at $2.05 billion in sales in 2012.7 > Designed to increase local blood flow to provide improvement in genital arousa
Slide 34: Sildenafil Cream, 3.6% - Phase 2b
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 o
Slide 35: Oral Sildenafil provided a compelling proof of concept for FSAD
Oral Sildenafil provided a compelling proof of concept for FSAD Statistically significant increases in Vaginal Pulse Statistically significant improvement in genital : : = i" + Question #2 - “After taking study medication, the Amplitude (VPA) stimulation (FIEI)* sensation/feeling in my genital (vagi
Slide 36: Sildenafil Cream, 3.6% - Phase 1 and Phase 2a Study Results
Sildenafil Cream, 3.6% - Phase 1 and Phase 2a Study Results Phase 1 Study of SST-6007 (Sildenafil Cream, 3.6%)? 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
Slide 37: Sildenafil Cream, 3.6% - Thermography Study Results
Sildenafil Cream, 3.6% - Thermography Study Results* Demonstrated time to effect (See Figure 1) Figure 1. Clitoral temperature change during the sexually explicit film Positive cognitive arousal responses Sildenafil Cream were noted. 25 Placebo Cream Significantly greater increases in genital temper
Slide 38: DARE-HRT1
Slide 39: The Vaginal Route of Drug Administration
The Vaginal Route of Drug Administration? > 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 to b
Slide 40: DARE-HRT1
DARE-HRT1* Combination bio-identical estradiol + bio-identical progesterone 28-day IVR for hormone therapy following menopause. There are no FDA approved options with both hormones in one monthly IVR. Over 45M women in U.S. approaching or in menopause* (— > Hormone Therapy (HT) HT remains the most e
Slide 41: DARE-HRT1
DARE-HRT1* Completed Phase 1 STUDY A Phase 1, Open-Label, 3-arm Parallel Group Study to Evaluate the Pharmacokinetics (PK) and Safety of DARE-HRT31 (80 ug and 160 yg Estradiol/ 4 mg and 8 mg Progesterone Intravaginal Rings) in Healthy Post-Menopausal Women. The topline data from the study support DA
Slide 42: DARE-HRT1 - U.S. Regulatory Strategy
DARE-HRT3 - U.S. Regulatory Strategy* Following clinical development, Daré intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT2, estradiol and progesterone, to utilize the U.S. Food and Drug Administration's (FDA) 505(b)(2) pathway to obtain marketing appr
Slide 43: Phase 1 and Preclinical Programs
Phase 1 and Preclinical Programs New investigational prescription drug delivery options for women
Slide 44: Advancing Products Women Want - Phase 1 and Preclinical
Advancing Products Women Want - Phase 1 and Preclinical Pregnancy Maintenance Phase a Study Preparation 1. First-in-category progesterone delivery for pregnancy maintenance including the prevention of preterm birth (DARE-PTBa) and for luteal phase support as part of an IVF regimen (DARE-FRTa). 2. IV
Slide 45: DARE-FRT1 and DARE-PTB1
DARE-FRT1 and DARE-PTBa* Bio-identical progesterone 14-day IVR for prevention of preterm birth and luteal phase support as part of an IVF treatment plan. There are currently no FDA approved products marketed in the U.S. that do not require daily dosing of progesterone. i) *505(b)(2) candidate* Preve
Slide 46: DARE-VVA1
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. There are currently no FDA approved products labeled for VVA treatment in HR+ breast cancer. Pot
Slide 47: DARE-VVA1 - Proof of Concept
DARE-VVAz - Proof of Concept 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 dryne
Slide 48: DARE-VVA1 Phase 1/2 Study
DARE-VVAi Phase 1/2 Stu Completed Phase 1 / 2 STUDY The Phase 1/2 study evaluated different doses of DARE-VVAi1, a tamoxifen vaginal insert, in 17 postmenopausal women with VVA. The study was a randomized, multi-center, double-blind, parallel-arm, placebo-controlled, dose-ranging study that evaluate
Slide 49: DARE-PDM1
DARE-PDM1* Proprietary hydrogel formulation of diclofenac for vaginal administration. Alternative to oral nonsteroidal anti-inflammatory drugs (NSAIDs) and hormonal contraceptives, which often can produce undesirable side effects. There are currently no FDA-approved vaginal diclofenac treatment opti
Slide 50: ADARE 204/214
ADARE 204/214* Novel 6 & 12-month injectable formulations of etonogestrel being developed as a longer-acting, reversible method of contraception with a more predictable return to fertility. There are currently no FDA approved injectable contraceptives available indicated for 6-12 months protection.
Slide 51: DARE-LARC1
DARE-LARC1* Long-Acting, Reversible Personal Contraceptive System — levonorgestrel-releasing implant drug delivery system designed to store and precisely deliver hundreds of therapeutic doses over years that a woman can turn on and off herself, according to her own needs, without further healthcare
Slide 52: DARE-GML
DARE-GML Glycerol monolaurate (GML) is a naturally occurring fatty acid monoester that has shown broad antimicrobial activity, killing bacteria, fungi and viruses, and represents a new class of antimicrobial agents. GML has the potential to be a first-in-category multi-target antimicrobial. Bacteria
Slide 53: DARE-LBT
DARE-LBT Novel hydrogel formulation for delivery of live biotherapeutics to support vaginal health There are currently no FDA approved live biotherapeutics for vaginal health. Grant from the Bill & Melinda Gates Foundation for $584,986 to support activities related to development of a vaginal thermo
Slide 54: Daring to be Different and Advancing Products Women Want
NASDAQ: DARE www.darebioscience.com db DARING TO BE DIFFERENT° AND ADVANCING daré PRODUCTS WOMEN WANT 54
Dare Bioscience — Investor Presentation (January 2023) on 6ix