Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (March 2023)
52 slides from Dare Bioscience's investor presentation, Mar 13, 2023
Slide 1: Daré Bioscience Corporate Presentation
= o Dare Bioscience — DARE IN ITALIAN, IT MEANS “TO GIVE.” IN ENGLISH, IT MEANS “TO BE BOLD.” NASDAQ: DARE Corporate Presentation: March 13, 2023 ©2023 Daré Bioscience | Allrights reserved www.darebioscience.com
Slide 2: Forward-Looking Statements; Disclaimers
EEE EE EEE EE | |} MEET | | Forward-Looking Statements; Disclaimers | Tt eee 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 || presentation includes ce
Slide 3: Daré Bioscience: Women's Health is our Sole Focus
Daré Bioscience: Women’s Health is our Sole Focus Meaningful market potential for differentiated products Addressing Compelling Markets First-line or first-in-category product opportunities across Where Innovation Matters the portfolio es ail sii sean vie eal FORE IVES Niering: ~$900M at peak ne -ap
Slide 4: An Efficient Investment Thesis
ent Thesis An Efficient Inves 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 Women’s He
Slide 5: Daré Portfolio — The Big Ideas
Daré Portfolio — The Big Ideas* (—__ Ovaprene® - 2% Hormone-free, Monthly Contraceptive © Pivotal Phase 3 study recruitment initiation mid-2023* DARE-LARC1 - 2% Long-Acting, Reversible Personal Contraceptive System (grant funded program) DARE-RHa - Hormone-free contraceptive target for women and men
Slide 6: Advancing Products Women Want - The Portfolio Snapshot
Advancing Products Women Want - The Portfolio Snapshot 0) daré’ PHASE 3/ REGULATORY FDA PRECLINICAL PHASE» sisal PIVOTAL SUBMISSION ‘APPROVED xacaro™ Ovaprene” an Hommene-e Monty Comocegion _Pivatal Phase 3 study recruitment initiation mid-2023* ‘rot hese Stay 1D spproved Sitdonafl ram, 3 656° hac S
Slide 7: FDA Approved - XACIATO
FDA Approved - XACIATO XACIATO™ (Clindamycin Phosphate) Vaginal Gel, 2% NDA approved December 7, 2021 QIDP, Fast Track and Priority Review Designations + XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis
Slide 8: Advancing Products Women Want - Late Stage Programs
Advancing Products Women Want - Late Stage Programs Ovaprene® Hormone-Free, Monthly Contraception cD Pivotal Phase 3 Study to Commence 2023* ¢ Investigational hormone-free, monthiy intravaginal contraceptive. * Designed to be an easy-to-use monthly option with effectiveness approaching hormonal meth
Slide 9: Advancing Products Women Want - Phase 1 and Preclinical
Advancing Products Women Want - Phase 1 and Preclinical 6 &12-Month Injectable Contraception Phase a Study Preparation Novel 6& a2-month injectable formulations of etonagestral being \Vulvarand Vaginal Atrophy Phase 2/2 Study Completed First.in-category hormone-free vaginal Lreatment for vulvar and
Slide 10: Daré: Advancing Products Women Want
Daré: Advancing Products Women Want heath ppetine with omens unceerecie Womens heath health pipeline ith |) approved, represents 9 wit | 77] generating more multiple upcoming a potential first-line or demonstrated success in clinical $ : i i and product development, interest as evidenced by program
Slide 11: Experienced Management & Board of Directors
Experienced Management & Board of Directors Management Team EFeEBTEEB Sabrina Martucci Johnson, MSc, MIM President & CEO John Fair Chief Commercial Officer Lisa Walters-Hoffert Chief Financial Officer David Friend, PhD Chief Scientific Officer Christine Mauck, MD, MPH Medical Director Annie Thurman,
Slide 12: Daré Financial Highlights
Daré Financial Highlights a ghlight Non-dilutive Cash received: 3Q-2022 : ~$18.0M + Upfront license fee from Organon $10.0 M 30-2022 Snapshot: + — Existing grant for DARE-LARCa: ~$8.0 M . October 2022 + Cash and equivalents 9/30/22: $40.4 M + Cashrebate, AU R&D program ($US) : ~s786,000 + Common sha
Slide 13: Upcoming Program Milestones
Daré — Working to Accelerate Innovation in Women’s Heal Ovaprene® (hormone-free monthly contraception) + Pivotal Phase 3 study recruitment initiation mid-2023 Upcoming Program Milestones*: XACIATO™ (clindamycin phosphate) vaginal gel, 2% + First commercial sale in 1H 2023 in the U.S. Sildenafil Crea
Slide 14: Commercialization Collaborator
Commercialization Collaborator:
Slide 15: Bacterial Vaginosis
acterial Vaginosis (+ — Recurring infection, difficult to treat effectively \ + Most common vaginal condition in women ages 15-44 Clinical Issue + — Estimated to affect ~23 million women in the US* + Bacterial Vaginosis increases health risks®, including increased risk of preterm birth, sexually tra
Slide 16: 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, first
Slide 17: 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 became effective June 2022. * Daré received a $10 million upfront p
Slide 18: 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 19: 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 20: U.S. Commercialization Collaborator / Phase 3 Development Collaborator
U.S. Commercialization Collaborator: (4s Phase 3 Development Collaborator:
Slide 21: Large Market Opportunity
Large Market Opportunity (Wamenrndtoramradiresvalttocthe Successful Contraceptive Brands Peak Sales: Contraception Market Segment (over 60 million women) : Tolls emai Age 54 tons) Source: US Census Bureau, 2017 National Dataset (2016s base population estimate for projection) hitpsypw-census.govfprog
Slide 22: Ovaprene Potential Market Opportunity
Ovapre' tential Market Opportunity There are approximately 65 million women in the US Aged 15-442 22 Million Current Non-Users *Currently use no contraception *Sexvally active *Not seeking pregnancy 35 Million Women? Potential Candidates for Ovaprene” aa Million Current Hormone-free Product Users Co
Slide 23: Contraception: What's Missing in Current Hormone-Free Options
Contraception: What Missing rrent Hormone-Free Options Hormone-free Options Pregnancies Expected (per 100 women) ** Least Effective Spermicides soy & Vaginal Gels? Condoms (male) cal Diaphragms (with a spermicide) a hormonal r Copper IUD <a Most Effective year oftyplel ee. Type
Slide 24: Ovaprene Investigational Hormone-Free, Monthly Contraceptive
Ovaprene® Investigational Hormone-Free, Monthly Contraceptive Desired Features of Physical Barrier ® Birth Control Products:** Design Features of Ovaprene:;? Three-dimensional, knitted polymer barrier +Efficacy 86% - 91% Expected Typical Use Effectiveness Approaching User-Controlled Hormone Contrace
Slide 25: Ovaprene - Commercial License Agreement with Bayer
Ovaprene® - Commercial License Agreement with Bayer* January 2020 - Bayer, which markets the $1 billion Mirena contraceptive franchise, and Daré announced the execution of a Bayer received the right to obtain exclusive US rights to commercialize the product, following completion of the pivotal clini
Slide 26: Ovaprene - Collaborative Research Agreement with NIH
Ovaprene?® - Collaborative Research Agreement with NIH* July 2022 - Daré announced that funding and (om pivotal Phase 3 study will be supported by the NICHD’s CIR oper tats suppor fete se ees Contraceptive Development Program which oversees the Contraceptive willbe provided! by the Nations! Institut
Slide 27: 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 ‘The PCT Clnieal Study Met its Primary Endpoint Ovaprene prevented the requisite number of sperm from reaching the cervix aerss all women and crept
Slide 28: 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® 28
Slide 29: FSAD: The Clinical Issue
FSA 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.* FSAD E HSDD The Clinical Issue The condition sho
Slide 30: What is the incidence of FSAD
What is the incidence FSA (- 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%.* % Market research estimates: > 33% of US women aged 21 to 60 (~ 20 million women), experience
Slide 31: 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.? Designed to increase local blood flow to provide improvement in genital arousal re
Slide 32: Sildenafil Cream, 3.6% - Phase 2b
Sildenafil Cream, 3.6% - Phase 2b Ongoing exploratory 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: patien
Slide 33: 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 z + Queso 2 - “After taking study medication, the ‘Amplitude (VPA)? stimulation (FIED senstonfsing in my gantal (gina, labia, cits) ar
Slide 34: 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 Phase 1 Study of SST-6007 (Sildenafil Cream, 3.6%)" . . Parameter Treatment Level Normal healthy postmenopausal women were dosed with escalating aa creer aqcem maces doses of Sildenafil Cream, 3.6%, using a cross-over study de
Slide 35: Sildenafil Cream, 3.6% - Thermography Study Results
Sildenafil Cream, 3.6% - Thermography Study Results* Demonstrated time to effect (See Figure 2) Figure 1. Clitoral temperature change during the sexually explicit film «Positive cognitive arousal responses ‘sildenafil Cream were noted. 2s Significantly greater increases in genital temperature after
Slide 36: Potential First-In-Category 28-day intravaginal ring
Potential First-In-Category 28-day intravaginal ring combination bio-identical estradiol and bio-identical progesterone for hormone therapy for treatment of vasomotor symptoms due to menopause. There are no FDA approved options with both hormones in one monthly IVR. 36
Slide 37: Intravaginal Ring (IVR) Technology
A.B Sharma, CP, “Routes famine of si Intravaginal 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
Slide 38: DARE-HRT1
RE-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 effectiv
Slide 39: DARE-HRT1 Completed Phase 1/2 Study
DARE-HRT1* Completed Phase 1 STUDY ‘APhase 2, Open-Label, 3-arm Parallel Group Study to Evaluate the Pharmacokinetics (PK) and Safety of DARE-HRT1 (80 ig and 160 ig Estradiol/ 4.mg and 8 mg Progesterone intravaginal Rings) in Healthy Post-Menopausal Women The topline data from the study support DARE
Slide 40: DARE-HRT1 U.S. Regulatory Strategy
DARE- alias U.S. Regulatory Strategy* Following clinical development, Daré intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRTa1, estradiol and progesterone, to utilize the U.S. Food and Drug Administration's (FDA) 505(b)(2) pathway to obtain marketing app
Slide 41: Phase 1 and Preclinical Programs
Phase 1 and Preclinical Programs New investigational prescription drug delivery options for women
Slide 42: Advancing Products Women Want - Phase 1 and Preclinical
Advancing Products Women Want - Phase 1 and Preclinical 6 &12-Month Injectable Contraception Phase a Study Preparation Novel 6& a2-month injectable formulations of etonagestral being \Vulvarand Vaginal Atrophy Phase 2/2 Study Completed First.in-category hormone-free vaginal Lreatment for vulvar and
Slide 43: DARE-VVA1
RE-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. Potent
Slide 44: DARE-VVA1 - Proof of Concept
DARE-VVAsz - Proof of Concept This exploratory study* in four postmenopausal women diagnosed with VA 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 45: DARE-VVA1 Phase 1/2 Study
DARE-VVAz Phase 1/2 Study* Completed Phase a / 2 STUDY The Phase a/2 study evaluated different doses of DARE-VVAi, a tamoxifen vaginal insert, in 27 postmenopausal women with VA. The study was a randomized, multi-center, double-blind, parallel-arm, placebo-controlled, dose-ranging study that evaluat
Slide 46: DARE-PDM1
AARE-PDM 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 option
Slide 47: DARE-FRT1 and DARE-PTB1
AARE-FRT1 and DARE-PTB1* 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. *sostaicaniatet Preve n of Pre
Slide 48: DARE 204/214
ARE 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, ~6
Slide 49: 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 50: DARE-GML
AARE-GM 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. Bacterial
Slide 51: DARE-LBT
ARE-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 thermos
Slide 52: Daring to be Different and Advancing Products Women Want
NASDAQ: DARE www.darebioscience.com 0) DARING TO BE DIFFERENT® AND ADVANCING doré! PRODUCTS WOMEN WANT 52