Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (October 2023)
56 slides from Dare Bioscience's investor presentation, Oct 16, 2023
Slide 1: Daré Bioscience: To Be Bold
DARE IN ITALIAN, IT MEANS “TO GIVE.” IN ENGLISH, IT MEANS “TO BE BOLD.” Women At Daré Bi lence, women’s health is Our Sole Focus. Innovation in women’s health needs to be a priority. We are working hard to identify and advance new therapies that provide additional choices and improve outcomes so tha
Slide 2: Forward-Looking Statements; Disclaimers
0) doré Forward-Looking Statements; Disclaimers This presentations or informational purposes only and isnot an offer to sel ora 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 — An Efficient Investment Thesis
me Women's Health — An Efficient Investment Thesis We believe investment in women’s health will Approximately 1% of healthcare research is invested be efficient and disproportionately impactful: in female-specific conditions beyond oncology.* - Women’s health products make up 27% of Women’s health c
Slide 4: Daré Portfolio — The Big Ideas
(Contraception (Bénat Health (eproduetve Health Menopause Sexual Health ve Daré Portfolio —The Big Ideas* @ Hormone-free, monthly contraceptive Long-acting injectable contraceptive Long-acting, reversible personal contraceptive system Hormone-free contraceptive target for women and men Hormone-free
Slide 5: Advancing Products Women Want: How Daré Creates Value
Advancing Products Women Want How Daré Creates Value Daré Commercial Collboarators * Innovative women’s health pipeline with <3) ~* ORGANON multiple upcoming program milestones anticipated. Examples of emerging and large pharmaceutical companies + Every program, if approved, represents a with brande
Slide 6: Advancing Products Women Want — The Portfolio Snapshot
b Advancing Products Women Want —The Portfolio Snapshot* doréoio PRE PHASES! REGULATORY FoR Collaborators cumican__PHASER_—_PHASE2—pyvoTat_ SUBMISSION __APPROVED fist commercial milestone achieved xAaciaTO™ A ORGANON — october 2023, Ovaprene® s+ Home Monthy Conception DD) “Procionseaswuy ie pproved
Slide 7: FDA Approved — XACIATO
2 FDA Approved —XACIATO gorcanen Commercialization Collaborator XACIATO™ (Clindamycin Phosphate) Vaginal Gel, 2% + XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in females 12 years of age and + The l
Slide 8: Late-Stage Programs: Ovaprene and Sildenafil Cream
Advancing Products Women Want Late-Stage Programs Contraception Goliaborator & (=~ Ovaprene® ceniindins © = Investigational Hormone-Free, Monthly Contraceptive Pivotal Phase 3 Study to Commence 2023* Potential first-in-category hormone-free contraception + Self-administered intravaginal drug/device
Slide 9: Late-Stage Programs: DARE-HRT1 and DARE-VVA1
Advancing Products Women Want Late-Stage Programs Menopause DARE-HRT14 Menopausal Hormone Therapy Phase 1/2 Study Completed IND and Phase 3 Study Preparations Underway * Potential first-in-category vaginal combination hormone delivery for treatment of vasomotor symptoms due to menopause * Self-admin
Slide 10: Phase 2-Ready Program: DARE-CIN
Advancing Products Women Want Phase 2-Ready Program Vaginal Health DARE-CIN (formerly R-131-2)4 Cervical intraepithelial neoplasia (CIN) Phase 1 and Proof-of-Concept Studies Completed Activities to support IND filing to enable progression to Phase 2 clinical development underway * Potential first-in
Slide 11: Earlier Stage Programs with Grant Funding Enhance the Pipeline
Earlier Stage Programs with Grant Funding Enhance the Pipeline PHASE3/ REGULATORY FoA ao PRECLINICAL PHASE PHASES PIVOTAL SUBMISSION APPROVED. DARE-POMa" [ll Primary Dysmenortiea phase study Commenced 2023 — DARE 204/214 i) 66812-Month injectable Contraception —ppae study Preparation DARE-FRTAIPTBS
Slide 12: Value Drivers
doré 0) a) Value Dri >) Meaningful market potential for differentiated products First-line or first-in-category product opportunities across the portfolio ers >) Diverse pipeline with independent outcomes One FDA-approved product and several clinical development stage candidates utilizing different
Slide 13: Working to Accelerate Innovation in Women's Health: Upcoming Milestones
b doré Daré — Working to Accelerate Innovation in Women’s Health Upcoming Program Milestones*: Ovaprene® (hormone-free monthly contraception) * Pivotal Phase 3 subject enrollment to begin 40-2023 Sildenafil Cream, 3.6% (FSAD/FSIAD) * Activities related to psychometric analyses to further refine the
Slide 14: Appendix
Appendix
Slide 15: Daré Portfolio by Category
(Bena Health (eprotictne Health jenopause Sexual Health (Ferity Ovaprene® - ast hormone-free, monthly contraceptive: Comm + Pivotal Phase 3 subject enrollment to begin 4Q-2023° DARE-204/224 - 1st 6 & 12-Month injectable contraceptive: DARE-LARCs - ast Long-acting, reversible personal contraceptive s
Slide 16: XACIATO (Clindamycin Phosphate) Vaginal Gel, 2%
doré XACIATO™ (Clindamycin Phosphate) Vaginal Gel, 2% One-time intravaginal administration * ORGANON zation Collaborator 16
Slide 17: FDA Approved — XACIATO
2 FDA Approved —XACIATO XACIATO™ (Clindamycin Phosphate) Vaginal Gel, 2% + XACIATO [zah-she-AH-toe] (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in females 12 years of age and older.* + Daré’s first FDA-approved product. *
Slide 18: Bacterial Vaginosis: Daré Innovation XACIATO
0) doré > Clinical Issue Bacterial Vaginosis Daré Innovation: XACIATO™ (Clindamycin Phosphate) Vaginal Gel, 2%* Recurring infection, difficult to treat effectively Most common vaginal condition in women ages 15-44 Estimated to affect ~23 million women in the US* Bacterial Vaginosis increases health
Slide 19: XACIATO Selected Safety Information
2. XACIATO Selected Safety Information + XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. * Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may rang
Slide 20: Ovaprene
doré Ovaprene® Investigational potential first-in-category, hormone-free, monthly birth control ii) U.S. Commercialization Collaborator Phase 3 Development Collaborator 20
Slide 21: Contraception: Large Market Opportunity
ee Contraception: Large Market Opportunity Successful Contraceptive Brands Peak Sales: Women in the Reproductive Health & Contraception Market Segment (over 60 million women) oY blest fe Population of women 15-44 years by ag Mirena" Hormone 1UD cetecaint US, 2020 devragetrcesng interne er) m9 (norei
Slide 22: Ovaprene Potential Market Opportunity
me Ovaprene® - Potential Market Opportunity? 35 Million Women 30 Million Women Potential Candidates for Not candidates for Ovaprene® Oveprene” 22 Million Current Non-Users ¥ Pill(20.3M) + Sterilization (20.5M) Injectable .sM) Pregnent/postpartum/ seeking pregnancy (.6M) Vaginal Ring (2.0M) Never had
Slide 23: What's Missing from Current Hormone-Free Options?
@ Contraception: “~~ What's Missing from Current Hormone-Free Options? Pregnancies Expected Hormone-free Options (per 00 women) ** Least Effective Spermicides & Vaginal Gels? Pa) Condoms (eae) *6 Diaphragms Ld Kvitieepermicide) 2 | ° Vy Copper UD <a | Most Effective 23
Slide 24: Ovaprene Investigational Hormone-Free, Monthly Contraceptive
Ovaprene® Investigational Hormone-Free, Monthly Contraceptive Physical Barier® Desired Features of Birth Control Products:" Design Features of Ovaprene:s7 Three-dimensional, +Efficacy 86% - 91% Expected Typical Use Effectiveness Arte palymer baer Approaching User-Controlled Hormone Contraception Hor
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 license agreement under which Bayer may commercialize Ovaprene investigational contraceptive in the US once approved by FDA?.
Slide 26: Ovaprene Collaborative Research Agreement with NIH
Ovaprene® - Collaborative Research Agreement with NIH + July 2021 - Daré announced that funding and clinical operations support for the Phase 3 will be provided by the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) under the CR
Slide 27: Ovaprene U.S. Regulatory Strategy
Ovaprene® - U.S. Regulatory Strategy? The PCT Clinical Study Met its Primary Endpoint Ovaprene prevented the requisite number of sperm from reaching the cervix across all women and all cycles evaluated. Specifically, in 100% of women and cycles, an average of less than five (< 5) progressively motil
Slide 28: Sildenafil Cream, 3.6%
doré Sildenafil Cream, 3.6% Potential First-In-Category treatment for Female Sexual Arousal Disorder (FSAD), and/or Female Sexual Interest/Arousal Disorder (FSIAD), which have no FDA-approved therapies 28
Slide 29: FSAD/FSIAD — The Clinical Issue & Prevalence
FSAD/FSIAD —The Clinical Issue & Prevalence + Female Sexual Arousal Disorder (FSAD) is characterized primarily by inability to attain or maintain sufficient genital arousal during sexual activity and, Female Sexual Interest/Arousal Disorder (FSIAD) is defined in the DSM-s as lack of, or significantl
Slide 30: Sildenafil Cream, 3.6% - Product Profile
.2.. Sildenafil Cream, 3.6% - Product Profile Topically-administered investigational Sildenafil Cream? is... * APDEs 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 promote improved genital arousa
Slide 31: Oral Sildenafil Provided a Proof of Concept for FSAD/FSIAD
0) doré Oral Sildenafil provided a compelling proof of concept for FSAD/FSIAD Statistically significant increasesin Vaginal Pulse Amplitude (VPA)! Pfizer VPA Clinical Lab Study Oral Viagra ‘Mean and Maximum VPAt gare kgt) + Tue hath premenopesl men restied ‘Statistically significant improvement in g
Slide 32: Sildenafil Cream 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 expos
Slide 33: Sildenafil Cream Demonstrated Time to Effect
Sildenafil Cream, 3.6% - 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 rep
Slide 34: Sildenafil Cream Phase 2b RESPOND Study Overview
.©.. Sildenafil Cream, 3.6% - Phase 2b RESPOND Study - Overview Exploratory Phase 2b clinical study designed to evaluate Sildenafil Cream vs. placebo over 12 weeks of double-blinded dosing following both a non-drug and placebo run-in period * Compared Sildenafil Cream vs. placebo used in patients’ h
Slide 35: Sildenafil Cream Phase 2b RESPOND Study Highlights
.2.. Sildenafil Cream, 3.6% - Phase 2b RESPOND Study — Highlights Positive findings from the exploratory Phase 2b RESPOND study of Sildenafil Cream, 3.6% in women with Female Sexual Arousal Disorder support continued development of Sildenafil Cream and selection of proposed primary endpoint assessme
Slide 36: DARE-HRT1
doré DARE-HRT1 Potential first-in-category 28-day intravaginal ring (IVR) combination bio-identical estradiol and bio- identical progesterone menopausal hormone therapy for treatment of vasomotor symptoms 36
Slide 37: Intravaginal Ring Technology Highlights
Intravaginal Ring (IV chnology Highlig The Vaginal Route of Drug Administration* Our IVR Technology Design Features: * Vaginal drug delivery offers many potential + Sustained drug delivery advantages due to large surface area, dense network of blood vessels and high elasticity due to presence of smo
Slide 38: Vasomotor Symptoms of Menopause: DARE-HRT1 Monthly Vaginal Ring
0) doré Vasomotor Symptoms of Menopause Daré Innovation: DARE-HRT1 Monthly Vaginal Ring + Inthe US, over 45M women are estimated to be in or approaching menopause; symptoms can last up to 10 years* >) Clinical + ~75% of menopausal women experience hot flashes* Issue + 3in5 menopausal women felt that
Slide 39: Menopause Society Hormone Therapy Position Statement
ause — Hormone Therapy Position Paper The Menopause Society~ {eoxng he Comenron THE MENOPAUSE SOCIETY POSITION STATEMENT 2022 hormone therapy position statement of The Menopause Society? Hormone therapy remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome
Slide 40: DARE-HRT1 Completed Phase 1/2 Study
DARE-HRT1* Completed Phase 1 STUDY +2 Open-label, 3-arm, parallel group study evaluated the pharmacokinetics (PK) and safety of DARE-HRT3 in healthy postmenopausal women First arm received one 28-day DARE-HRT1 IVR (17B2- estradiol (E2) 80 g/d with progesterone (Pa) 4 mg/d); second arm received one 2
Slide 41: DARE-HRT1 U.S. Regulatory Strategy
doré ® DARE-HRT1- U.S. Regulatory Strategy* Following clinical development, Daré intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRTa, estradiol and progesterone, to utilize the FDA's 505(b)(2) pathway to obtain marketing approval of DARE-HRT1 in the U.S.
Slide 42: DARE-VVA1
doré DARE-VVA1 Potential first-in-category hormone-free vaginal treatment for VVA. Proprietary formulation of tamoxifen for intravaginal administration 42
Slide 43: DARE-VVA1: Proprietary Tamoxifen Formulation for Intravaginal Use
© DARE-VVA1* Proprietary tamoxifen formulation for intravaginal ration for vulvovaginal atrophy (VVA), a chronic condition characterized by pain during intercourse, vaginal dryness and irritation. * There are currently no FDA-approved vaginal, hormone- free treatments for VVA. * Approximately 4 mill
Slide 44: DARE-VVA1 Proof of Concept
2. 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
Slide 45: DARE-VVA1 Phase 1/2 Study
2 DARE-VVAs Phase 1/2 Study Completed Phase 1 / 2 Study Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVAu: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy* Objective: + This study aimed to measure safety, systemic pharmacokinetics
Slide 46: DARE-CIN (formerly R-132-2)
doré DARE-CIN (formerly R-132-2) Potential first-in-category non-surgical, pharmaceutical intervention for the treatment of CIN2+. Proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert.
Slide 47: DARE-CIN Lopinavir and Ritonavir Vaginal Insert
© DARE-CIN* geneiynso-nnniionsinagaia DARE-CIN is a proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert being developed for the treatment of CIN, also referred to as cervical dysplasia, and other HPV-related pathologies. * There are currently no FDA-approved, p
Slide 48: DARE-CIN Proof of Concept
© DARE-CIN¥ geneiynso-nnniionninagaina Proof of Concept * ASingle-Arm, Proof-Of-Concept Trial of Lopinavir/Ritonavir? as a Treatment for HPV-Related Pre- Invasive Cervical Disease.? + Atotal of 23 women with HSIL* were treated with lopinavir/ritonavir during which time no adverse reactions were repo
Slide 49: HPV Associated Conditions In the United States
2 HPV Associated Conditions In the United States . HPV Infections? HPV Infections + ~42.5 M Americans infected with HPV + ~13 M new infections annually Low-Grade Dysplasia Low-Grade Dysplasia (esate * ~1.5 M women diagnosed annually High-Grade Dysplasia? * 196,000 CIN2+ cases annually (74% were wome
Slide 50: DARE-PDM1 Primary Dysmenorrhea
Advancing Products Women Want Phase 1 Stage Program Reproductive Health DARE-PDM1*4 Primary Dysmenorrhea Phase 1 Study Topline Data in 2023* + Potential first-in-category treatment for primary dysmenorrhea. + Proprietary hydrogel formulation of diclofenac for vaginal administration. * Alternative to
Slide 51: Phase 1-Ready Programs
Advancing Products Women Want Phase 1-Ready Programs Contraception Fertility DARE 204/2144 Sentfinding [I -ss=~ DARE-FRTa/PTBa" Seantsuncina [SY 6 & 12-Month Injectable Contraception Pregnancy Maintenance Phase 1 Study Preparation Phase 1 Study Preparation * Novel 6 & 12-month injectable formulation
Slide 52: Preclinical Stage Programs: DARE-LARC1 and DARE-LBT
Advancing Products Women Want Preclinical Stage Programs Contraception DARE-LARC34/ Stent funding foundation grant Way) =~ Long-Acting, Reversible Personal Contraceptive System * Potential first-in-category Levonorgestrel-releasing, long- acting contraceptive implant that a woman can turn on and off
Slide 53: Preclinical Stage Programs: DARE-GML and DARE-RH1
Advancing Products Women Want Preclinical Stage Programs Vaginal Health Contraception DARE-GML DARE-RH1 Novel Antimicrobial Glycerol Monolaurate (GML) Male or Female Contraceptive Target + Anaturally occurring fatty acid monoester that has * Apotential new rapidly reversible, non-hormonal shown broa
Slide 54: Preclinical Stage Programs: DARE-PTB2
Advancing Products Women Want Preclinical Stage Programs Fertility DARE-PTB2. eaninnaina ED) Prevention and Treatment of Idiopathic Preterm Birth (PTB) * Potential new approach for the prevention and treatment of idiopathic PTB through a stress response protein target. * Grant funding for proof-of-c
Slide 55: Experienced Management & Board of Directors
Experienced Management & Board of Directors Sabrina Martucci Johnson, sc, MIM President CFO John Fale ‘Chit Commer Ofer Lisa Walters Hoffer. hit nana Offer David Friend, PRD Chie Scent ofc Christine Mauck, MD, MPH Medial Drector ‘Annie Thurman, MD, FACOG Mesa rector Marke Walters Vie Presiden of Ope
Slide 56: Daré Bioscience: To Be Bold
DARE IN ITALIAN, IT MEANS “TO GIVE.” IN ENGLISH, IT MEANS “TO BE BOLD.” Women At Daré Bi lence, women’s health is Our Sole Focus. Innovation in women’s health needs to be a priority. We are working hard to identify and advance new therapies that provide additional choices and improve outcomes so tha
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