Dare Bioscience, Inc. · NASDAQ:DARE

Dare Bioscience — Investor Presentation (September 2023)

64 slides from Dare Bioscience's investor presentation, Sep 11, 2023

  1. Slide 1: Daré Bioscience: Women's Health is Our Sole Focus

    DARE IN ITALIAN, IT MEANS “TO GIVE.” o IN ENGLISH, IT MEANS “TO BE BOLD.” | care: Women At Daré Bioscience, 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 out

  2. Slide 2: Forward-Looking Statements; Disclaimers

    0) doré Forward-Looking Statements; Disclaimers This presentation is for informational purposes only and is not an offerto sell ora solicitation of an offer to buy any securities of Daré Bioscience, Inc, ("Daré" or the “Company”). Ths presentation includes certain information obtained from trade and

  3. Slide 3: Experienced Management & Board of Directors

    Experienced Management & Board of Directors Management & Board Experience Annie Thurman, MD, FACOG Media Director Robin Steele, JD, LLM. Sabrina Marto Johnson, Willian Rastettr, PAD se, MIM Gime Posen’ O POma eT. Ales John Fir = ¥ he ConmerdilOficer eoQiun Sateinnie payer Baxter — blogenidec esi Gro

  4. Slide 4: Advancing Products Women Want

    Advancing Products Women Want Daré Commercial Collboarators: How Daré Creates Value * Innovative women’s health pipeline with -# ORGANON multiple upcoming program milestones anticipated. Examples of emerging and large pharmaceutical companies with branded women’s health products. abbpvie Agile. Wasi

  5. Slide 5: Daré Bioscience: Women's Health is our Sole Focus

    Daré Bioscience: Women’s Health is our Sole Focus 7) 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 development stage candidate

  6. Slide 6: Women's Health — An Efficient Investment Thesis

    b doré 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

  7. Slide 7: Daré Portfolio — The Big Ideas

    0) doré e.. epost Health jenopause Daré Portfolio —The Big Ideas* @ ([Cohtraception Health Sexual Health (Cetttry Ovaprene® - ast Hormone-free, Monthly Contraceptive: + Pivotal Phase 3 subject enrollment to begin 40-2023" DARE-204/214 - ast 6 & 12-Month Injectable Contraceptive: Grantfunding [2)° DA

  8. Slide 8: Advancing Products Women Want - The Portfolio Snapshot

    dorébio b Advancing Products Women Want - The Portfolio Snapshot PRE PHASES/ REGULATORY FA Collaborators cxmcay ———_iPR PIVOTAL SUBMISSION __ APPROVED XAcIATO™ WIGRGANON NDA Approved Dec. 7, 2023. St ceemnrenmnereemen) yarjanee Hormane-re, Monthly Contraception wise NTTotalPhese 3 study IDE approved

  9. Slide 9: Advancing Products Women Want - The Portfolio Snapshot

    b Advancing Products Women Want - The Portfolio Snapshot dorébio PHASE) REGULATORY FDA PRE-CLINI PHASE » PHASE 2 eam E-CUINICAL a PIVOTAL SUBMISSION APPROVED. DARE-PDM:* Primary Oysmenottnes ‘ase 1 Study Commenced 2023, iD DARE204/214° ba 6 &12-Month bjectable Contraception phase 1 study Preparation

  10. Slide 10: FDA Approved — XACIATO

    0) ce 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 female patients 12 years of age and older.* + Daré’s first FDA-approve

  11. Slide 11: Late-Stage Programs: Ovaprene and Sildenafil Cream

    Advancing Pro cts Women Want Late-Stage Programs Contraception Colaborators <=". Ovaprene® sraresunsing “29 Investigational Hormone-Free, Monthly Contraceptive Pivotal Phase 3 Study to Commence 2023* Potential first-in-category hormone-free contraception + Self-administered intravaginal drug/device

  12. Slide 12: Late-Stage Programs: DARE-HRT1 and DARE-VVA1

    Advancing Products Women Want Late-Stage Programs Menopause Vaginal Health DARE-HRT14 DARE-VVA14 Menopausal Hormone Therapy Vulvovaginal Atrophy (VVA) Phase 1 / 2 Study Completed Phase 1/ 2 Study Completed IND and Phase 3 Study Preparations Underway IND and Phase 2 Study Preparations Underway + Pote

  13. Slide 13: 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 a and Proof-of-Concept Studies Completed Activities to support IND filing to enable progression to Phase 2 clinical development underway * Potential first-in

  14. Slide 14: Phase 3 Stage Program: DARE-PDM1

    Advancing Products Women Want Phase 1 Stage Program Reproductive Health DARE-PDM14 Primary Dysmenorrhea Phase a Study Topline Data in 2023* + Potential first-in-category treatment for primary dysmenorrhea. + Proprietary hydrogel formulation of diclofenac for vaginal administration. + Alternative to

  15. Slide 15: Phase 1-Ready Programs

    Advancing Products Women Want Phase a-Ready Programs Contraception Fertility DARE 204/214/ S7tsunaioa [ys DARE-FRT1/PTBa4 srertfursina [ym 6 & 12-Month Injectable Contraception Pregnancy Maintenance Phase a Study Preparation Phase a Study Preparation + Novel 6 & 12-month injectable formulations of +

  16. Slide 16: Preclinical Stage Programs

    Advancing Pro cts Women Want Preclinical Stage Programs Contraception DARE-LARC4A4 Giant finding soundaion sont pc Long-Acting, Reversible Personal Contraceptive System + Potential first-in-category Levonorgestrel-releasing, long- acting contraceptive implant that a woman can turn on and off herself

  17. Slide 17: Preclinical Stage Programs

    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

  18. Slide 18: Preclinical Stage Programs

    Advancing Products Women Want Preclinical Stage Programs Fertility DARE-PTB2_ &iitsinaing E)-==~ 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-

  19. Slide 19: Daré — Working to Accelerate Innovation in Women's Health

    2. Daré —Working to Accelerate Innovation in Women’s Health Upcoming Program Milestones*: * XACIATO™ (clindamycin phosphate) vaginal gel, 2% * First commercial sale in 2023 * Ovaprene® (hormone-free monthly contraception) + Pivotal Phase 3 subject enrollment to begin 40-2023 * Sildenafil Cream, 3.6%

  20. Slide 20: XACIATO (Clindamycin Phosphate) Vaginal Gel, 2%

    doré XACIATO™ (Clindamycin Phosphate) Vaginal Gel, 2% One-time intravaginal administration 20

  21. Slide 21: Bacterial Vaginosis

    0) ee Bacterial Vaginosis Daré Innovation: XACIATO™ (Clindamycin Phosphate) Vaginal Gel, 2%* >) Clinical Issue 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

  22. Slide 22: 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. * Daré's first FDA-approved product. * Organon and Daré are working towards a 2023 U.S

  23. Slide 23: 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 global rights to XACIATO.* The license + Daré received a s20 million upfront became effective June 2022. payment in 30 2022 anda sa million . pa

  24. Slide 24: XACIATO Selected Safety Information

    © 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 range

  25. Slide 25: Ovaprene

    doré Ovaprene® Investigational potential first-in-category, hormone-free, monthly birth control © = US. Commercalization Collaborator Phase 3 Development Collaborator 25

  26. Slide 26: Contraception: Large Market Opportunity

    cos Contraception: Large Market Opportunity Women in the Reproductive Health & Contraception Market Segment (over 60 million women) Population of women 15-44 years by age: Us, 2020 + Physician inserted, long-acting, Age(years) us 5 us (Percent) (Count) vs10¥8 189 20200 40 2roreo26 soaayn 150 ro7a060

  27. Slide 27: Ovaprene - Potential Market Opportunity

    a Ovaprene® - Potential Market Opportunity»? 35: Women 30 Million Women Potential Candidates for Not candidates for Ovaprene” Ovaprene® 22 Million 32 Million Current Non-Users Hormonal Y Pill(20.3M) Injectable (5M) 7 Sterilization (205M) + Vaginal Ring (2.0M) Pregnantipostpartum/ seeking pregnancy (

  28. Slide 28: Contraception: What's Missing from Current Hormone-Free Options?

    @ Contraception: “What's Missing from Current Hormone-Free Options? Pregnancies Expected Hormone-free Options (per 200 women) ** Least Effective Spermicides >; & Vaginal Gels* D Condoms (male) Diaphragms Ld (with aspermicide) (@) Easy-to-use monthly option | copper UD « a2 aa Most Effective 28

  29. Slide 29: Ovaprene Investigational Hormone-Free, Monthly Contraceptive

    Ovaprene® Investigational Hormone-Free, Monthly Contraceptive Desired Features of Birth Control Products:* Design Features of Ovaprene:s? Physical Barrier" Threecimensiona +Efficac 86% - 91% Expected Typical Use Effectiveness sted pater barier uy Pie terrane s ' Approaching User-Controlled Hormone C

  30. Slide 30: Ovaprene - Commercial License Agreement with Bayer

    Ovaprene® - Commercial License Agreement with Ba * January 2020 - Bayer, which markets the $2 * Bayer received the right to obtain exclusive billion Mirena contraceptive franchise, and US rights to commercialize the product, Daré announced the execution of a license following completion of the pivot

  31. Slide 31: 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 CRA

  32. Slide 32: 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 motile

  33. Slide 33: 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 33

  34. Slide 34: 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-5 as lack of, or significantly

  35. Slide 35: 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 arousal

  36. Slide 36: Oral Sildenafil provided a compelling proof of concept for FSAD/FSIAD

    0) doré Oral Sildenafil provided a compelling proof of concept for FSAD/FSIAD ‘Statistically significant increases in Vaginal Pulse Amplitude (VPA)! Pfizer VPA Clinical Lab Study - Orat Viagra ‘Mean and Maxinnura VPAt i Poss q Z ‘Statistically significant improvement in genital stimulation (FIE1 Pfi

  37. Slide 37: Sildenafil Cream, 3.6% - Phase 1 and Phase 2a Study Results

    Sildenafil Cream, 3.6% - Phase 1 and Phase 2a Study Results Phase 2 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

  38. Slide 38: Sildenafil Cream, 3.6% - Thermography Study Results

    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-re

  39. Slide 39: Sildenafil Cream, 3.6% - Phase 2b RESPOND Study - Overview

    .2.. 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

  40. Slide 40: Sildenafil Cream, 3.6% - 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 assessmen

  41. Slide 41: 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. a

  42. Slide 42: Intravaginal Ring (IVR) Technology Highlights

    vaginal Ring (IVR chnology Highlights 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 smoo

  43. Slide 43: Vasomotor Symptoms of Menopause

    0) we Vasomotor Symptoms of Menopause Daré Innovation: DARE-HRTa Monthly Vaginal Ring In the US, over 45M women are estimated to be in or approaching menopause; symptoms can last up to a0 years* ~75% of menopausal women experience hot flashes? >) Clinical : Issue + 3in.5 menopausal women felt that t

  44. Slide 44: Menopause — Hormone Therapy Position Paper

    Menopause — Hormone Therapy Position Paper oY NAMS POSITION STATEMENT 3in4a NAMS 2022 hormone therapy position statement of Women weontersocr” The North American Menopause Society? say menopause has interfered with their Hormone therapy remains the most effective treatment for lives. 64% of women sa

  45. Slide 45: DARE-HRT1 Completed Phase 1 Study

    DARE-HRT1* Completed Phase 1 STUDY +? + Open-label, 3-arm, parallel group study evaluated the pharmacokinetics (PK) and safety of DARE-HRT1 in healthy postmenopausal women + First arm received one 28-day DARE-HRT2 IVR (17f2- estradiol (E2) 80 jigid with progesterone (Pa) 4 mg/d); second arm received

  46. Slide 46: DARE-HRT1 - U.S. Regulatory Strategy

    © 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-HRT4, estradiol and progesterone, to utilize the FDA's 505(b)(2) pathway to obtain marketing approval of DARE-HRT1 in the U.S. * Da

  47. Slide 47: DARE-VVA1

    doré DARE-VVA1 Potential first-in-category hormone-free vaginal treatment for WA. Proprietary formulation of tamoxifen for intravaginal administration. 47

  48. Slide 48: DARE-VVA1

    © DARE-VVA1* Proprietary tamoxifen formulation for intravaginal administration 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

  49. Slide 49: DARE-VVA1 - Proof of Concept

    © DARE-VVA1- 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 d

  50. Slide 50: DARE-VVA1 Phase 1/2 Study

    © DARE-VVA2 Phase 2/2 Study Completed Phase 1/ 2 Study Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVAz: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy* Objective: + This study aimed to measure safety, systemic pharmacokinetics a

  51. Slide 51: DARE-CIN

    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. 51

  52. Slide 52: DARE-CIN

    b © DARE-CIN* tenciynssioaniansnagnina 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,

  53. Slide 53: DARE-CIN - Proof of Concept

    b © DARE-CIN* tenciynssioaniansnagnina Proof of Concept * ASingle-Arm, Proof-Of-Concept Trial of Lopinavir/Ritonavirt 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 repor

  54. Slide 54: 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 [LSIL/CIN4] Cenvcol Low-Grade Dysplasi. + ~1.5 M women diagnosed annually High-Grade Dysplasia? * 196,000 CIN2+ cases annually (74%

  55. Slide 55: Phase 1 & Phase 1-Ready Programs; Preclinical Programs

    Phase 1 & Phase 1-Ready Programs Preclinical Programs 55

  56. Slide 56: Advancing Products Women Want: Phase 1 & Phase 1 Ready Programs

    0) doré Advancing Products Women Want Phase a & Phase a Ready Programs DARE-PDM1" Primary Dysmenorthea Phase 1 Study Commenced DARE 204/214” {68 12-Month Injectable Contraception Phase 1 Study Preparation DARE-FRT1/PTBI" Pregnancy Maintenance Phase 1 Study Preparation 2. Fesvincatagory weamnent fr p

  57. Slide 57: DARE-PDM1

    © DARE-PDM1* Proprietary hydrogel formulation of diclofenac for vaginal administration. Alternative to oral nonsteroidal antiinflammatory drugs (NSAIDs) and hormonal contraceptives, which often can produce undesirable side effects. + There are currently no FDA-approved vaginal diclofenac treatment o

  58. Slide 58: DARE-FRT1 and DARE-PTB1

    doré ® DARE-FRT2 and DARE-PTB1* Bio-identical progesterone up to 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. Prevention of Pre

  59. Slide 59: DARE 204/214

    © DARE 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 of prot

  60. Slide 60: DARE-LARC1

    © DARE-LARC1* Sen aman ome EB) =~ * 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, with

  61. Slide 61: 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 bea first-in-category multi-target antimicrobial. + Bacte

  62. Slide 62: DARE-LBT

    © DARE-LBT {foundation grant 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 developm

  63. Slide 63: DARE-PTB2

    © DARE-PTB2 —— Proof-of-concept target validation studies in support of a new approach for the prevention and treatment of idiopathic PTB. There are currently no marketed, FDA-approved products indicated for the prevention of preterm birth. + Grant from the Eunice Kennedy Shriver National Institute

  64. Slide 64: Daré Bioscience: Women's Health is Our Sole Focus

    DARE IN ITALIAN, IT MEANS “TO GIVE.” o IN ENGLISH, IT MEANS “TO BE BOLD.” | care: Women At Daré Bioscience, 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 out

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