Slide 1: Transforming Women's Health
October 25, 2024 l dd TRANSFORMING WOMEN’S HEALTH We founded Daré Bioscience with the sole focus of putting women’s health first - to boldly address existing therapeutic gaps and give women the novel treatment options they want and need. IN ITALIAN, IT MEANS “TO GIVE.” IN ENGLISH, IT MEANS “TO BE BO
Slide 2: Forward-Looking Statements; Disclaimers
l » Forward-Looking Statements; Disclaimers 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
Slide 3: We are experts in developing women's health therapeutics
“ We are experts in developing women’s health therapeutics We have prioritized building strong relationships and delivering results, so collaborators can turn to us as new opportunities arise. Our broad portfolio allows us to integrate clinical and regulato gt 9 "Y clinical trials learnings from acr
Slide 4: Why invest in women?
Why invest in women? = We believe that investment in women’s health will be Women's He. An Efficient. efficient and Limited R&D Investment Large Commercial Opportunity * Only approximately 1% of * Women’s health products healthcare research make up 27% of total spending is invested in non- blockbust
Slide 5: Daré Bioscience Corporate Highlights
Daré Bioscience Corporate Highlights Infrastructure-light, partnering model Potential high-impact, first-in-category product candidates that represent large allows the Company to pursue a portfolio approach with several potential commercial products under the Daré umbrella Derisked regulatory strate
Slide 6: The Daré Value Proposition
“ The Daré Value Proposition We leverage the insights and efficiencies of a deep vertical to mitigate risk and efficiently bring high-impact products to market with commercial collaborators. We deploy established active pharmaceutical A, P : . . ...and we have completed successful clinical trials wi
Slide 7: Innovative Treatments That Women Want and Need
@ Innovative Treatments That Women Want and Need Our investigational products are some of the most potentially disruptive therapeutic candidates for women in decades ADDRESSABLE MARKET PHASE 3/ REGULATORY FDA ASSET* (millions of women) = PRE-CLINICAL PHASE 1 PHASE 2 PIVOTAL SUBMISSION APPROVED (clin
Slide 8: XACIATO (Clindamycin Phosphate) Vaginal Gel 2%
(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 (BV) in females 12 years of age and older* if In less than five years, Daré: 4 In-licensed the asset with a 30-pat
Slide 9: BV Market Opportunity
! “ BV Market Opportunity Bacterial vaginosis is the most common cause of vaginal symptoms among women#! women in the US are affected by BV [7] BV Prevalence 2 11) ( of U.S. women of reproductive 9 % age (14-49) are affected by BVE) drug treated population!) Existing Rx is suboptimal with clinical c
Slide 10: Ovaprene: Investigational hormone-free, monthly contraceptive
Invest ational iets horn ne-free, month Phase 3 contraceptive efficacy I'study curtently enrolling Daré’s Potential First-in-Category Contraceptive Product Pivotal Study Collaborator + Minority int Designed to be an easy-to-use monthly option with effectiveness approaching hormonal methods. There ar
Slide 11: Ovaprene - Potential Market Opportunity
D Ovaprene® - Potential Market Opportunity* 35 Million Women Potential Candidates for Ovaprene® 2 Million Current Hormonal Product Users 12 Million Current Non-Users Currently use no contraception * Sexually active Pill (10.3M) Injectable/patch (1.6M) Vaginal Ring (1.0M) Emergency contraception (0.0
Slide 12: Ovaprene - Pre-Pivotal Study
“ Ovaprene® - Pre-Pivotal Study * The Ovaprene® Pre-Pivotal Postcoital Test (PCT) study met its Ovaprene® Pre-Pivotal Study Results primary endpoint. 80 * In100% of women and cycles, Ovaprene prevented the requisite number of sperm from reaching the cervix. * Asuccessful cycle was defined as an aver
Slide 13: Ovaprene - U.S. Regulatory Strategy
Ovaprene® - U.S. Regulatory Strategy* Pivotal study design2 *Premarket approval (PMA) strategy; the Center for Devices and Radiological Health (CDRH) as lead review division. * This is a non-comparative study meaning all women will use Ovaprene — there is no Pivotal study enrollment placebo * Target
Slide 14: Potential First-in-Category Treatment for Female Sexual Arousal Disorder
Daré’s Potential First-in-Category Treatment for Female Sexual Arousal Disorder (FSAD) (> ] FSAD is characterized primarily by inability to attain or maintain sufficient genital arousal during sexual activity and is clinically analogous to erectile dysfunction in men. As with male erectile dysfuncti
Slide 15: Path Forward for Sildenafil Cream
t “ Path Forward for Sildenafil Cream Key Takeaways- Phase 2b Clinical Study * Phase 2b Clinical Study designed to evaluate Sildenafil Cream vs. placebo over 12 weeks * To Daré’s knowledge, first study specifically evaluating a potential therapy for treatment of FSAD * Post-hoc analyses showed that
Slide 16: Menopause is Having a Moment
Menopause is Having a Moment * The menopause market is a large and growing market, with more than 1 billion people worldwide expected to be in menopause by 20257. Approximately 51% of menopausal women experience moderate to severe vasomotor symptoms (VMS) or hot flashes.” The global market for menop
Slide 17: What Causes Menopause?
q What Causes Menopause? Symptoms of Menopause Memory Issues Difficulty concentrating or ‘experiencing memory lapses. Hot Flashes Sudden feeling of warmth with sweating and red skin, affects ~75% of menopausal women. ‘Also called vasomotor symptoms (VMS) Vaginal Dryness Reduced moisture and tissue e
Slide 18: Daré Menopause Programs
t dp Daré Menopause Programs Hormone Therapy Product Candidate DARE-HRT1 Monthly Vaginal Ring for the Vasomotor Symptoms of Menopause Phase 1/2 study completed; IND related activities to support a single Phase 3 study underway.” Bioidentical estradiol & progesterone in one product Highly acceptable,
Slide 19: DARE-HPV
© There are currently no FDA-approved, non-surgical pharmaceutical interventions to treat HPV-related cervical dysplasia. © There are no FDA-approved treatments for HPV infection. DARE-HPV is a proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert. © Phase 1 and
Slide 20: Safe and Effective HPV Treatments Remain an Unmet Need
@ Safe and Effective HPV Treatments Remain an Unmet Need . HPV-Related Cervical Di per year in the U.S.+ * HPVis the most common sexually transmitted infection in >11 million women the United States. acquire a new infection * Today, cervical precancers (dysplasia) are monitored until they reach alat
Slide 21: Earlier Stage Programs with Grant Funding Enhance the Pipeline
D Earlier Stage Programs with Grant Funding Enhance the Pipeline Australia R&D Cash Rebate = = i) Foundation grant up to “$49 Foundation Grant & pt ae NIH) oa '505(b)(2) regulatory pathway ADDRESSABLE MARKET - a 50% menstruating DARE-PDMa' women experience Pelvic Pain dysmenorrhea A DARE 204/234 22
Slide 22: Upcoming Milestones
Ovaprene® = Phase 3 study commenced 4O 2023 = Phase 3 study updates Sildenafil Cream, 3.6% = End-of-Phase 2 meeting with FDA occurred Dec. 2023 = Phase 3 program updates, including additional FDA feedback and initial Phase 3 study timing = Collaboration strategy DARE-HPV = IND and Phase 2 study prep
Slide 23: Appendix
( ©2024, ai Daré Bioscience | All rights reserved 3
Slide 24: Ovaprene: Hormone-free, monthly contraceptive
int A horm free, monthly ‘contraceptive Phase 3 contraceptive efficacy I'study curtently enrolling Daré’s Potential First-in-Category Contraceptive Product Designed to be an easy-to-use monthly option with effectiveness approaching hormonal methods. There are currently no FDA-approved monthly, hormo
Slide 25: Contraception: Market Opportunity
D Contraception: Market Opportunity Women in the Reproductive Health & Contraception Market Segment (over 60 million women) Population of women 15 - 44 years by age: US, 2020 Age (Years) US US (Percent) (Count) 15-19 yrs 15.9 10,266,332 20-29 yrs 24.0 21,918,026 30-39 yrs 34:3 22,159,866 40-44 yrs 1
Slide 26: Contraception: What's Missing from Current Hormone-Free Options?
D Contraception: What's Missing from Current Hormone-Free Options? G 7 O ° Hormone-free Options Anti-sperm vaginal contraceptives {includes spermicides and other anti-sperm agents) Diaphragms (with spermicide) Condoms (male) Copper |UD Pregnancies Expected (per 100 women) *? 21-28 17 3B <1 Mast Effe
Slide 27: Ovaprene - Commercial License Agreement with Bayer
l @ Ovaprene® - Commercial License Agreement with Bayer B January 2020 - Bayer, which markets the $1 billion A i ; A A BAYER Mirena contraceptive franchise, and Daré E announced the execution of a license agreement under which Bayer may commercialize Ovaprene —Mirena®is the #1 investigational contra
Slide 28: Ovaprene - Collaborative Research Agreement with NIH
I D Ovaprene® - Collaborative Research Agreement with NIH "This collaboration between Daré and NICHD marks an important milestone in Women’s Healthcare Innovation. Women are at the center of everything we do and we are so pleased to continue to partner with Daré in support of our mission We’re For H
Slide 29: Potential First-in-Category Treatment for FSAD
Daré’s Potential First-in-Category Treatment for Female Sexual Arousal Disorder (FSAD) Female Sexual Arousal Disorder FSAD Market Analysis FSAD is characterized primarily by inability to attain or maintain sufficient genital arousal during sexual activity. FSAD is clinically analogous to erectile dy
Slide 30: 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 Amplitude (VPA)* istic signi i in genital stin ion (FlEI)2 * Question #2 — “After taking study medication, the Pfizer VPA Clinical Lab Study Oral Viagra Pfizer Clinical Field Study
Slide 31: Overview of Phase 2b Study
D Overview of Phase 2b Study Phase 2b, Exploratory, Randomized, Placebo-Controlled, Trial of Sildenafil Cream 3.6% for the Treatment of Female Sexual Arousal Disorder in Healthy Premenopausal Women (#NCT04948151) — N=200 Randomized, 101 Sildenafil Cream vs 99 Placebo Over 10,000 women i; ‘ jl Random
Slide 32: Phase 2b - Exploratory Post-Hoc Analyses
l “ Phase 2b — Exploratory Post-Hoc Analyses* Post-hoc analyses were conducted on enrollment female sexual dysfunction diagnosis category so that efficacy could be evaluated in the study sub-populations based on concomitant diagnoses, such that the patient population most likely to benefit from the
Slide 33: Sildenafil Cream, 3.6%: Phase 1 and Phase 2a Study Results
D 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 exposure c
Slide 34: DARE-HRT1: Menopausal hormone therapy
ausal hormone therapy 4505(b)(2) regulatory pathway anticipated. Potential first-in-category vaginal combination hormone delivery for treatment of vasomotor symptoms due to menopause. Intravaginal ring (IVR) designed to release bio- identical estradiol and bio-identical progesterone over 28 days. Se
Slide 35: Vasomotor Symptoms of Menopause
> Vasomotor Symptoms of Menopause Daré Innovation: DARE-HRT1 Monthly Vaginal Ring In the US, over 45M women are estimated to be in or approaching menopause; symptoms can last up to 10 Clinical years* Issue * ~75% of menopausal women experience hot flashes? * 3in 5 menopausal women felt that they wer
Slide 36: Menopause - Renewing the Market Opportunity
“ Menopause — Renewing the Market Opportunity US Estimated HT Patients? Prior to the 2002 WHI report, the Premarin family of products achieved ~$2B in peak revenue, led by sales of the combination HRT products Prempro and Premphase.’ The WHI report caused hormone therapy market to collapse. While su
Slide 37: Menopause - Hormone Therapy Position Paper
l dp Menopause — Hormone Therapy Position Paper THE MENOPAUSE SOCIETY The POSITION STATEMENT pe 2022 hormone therapy position statement of The Menopause Society? Hormone therapy remains the most effective treatment for VMS and the genitourinary syndrome of menopause and has been shown to prevent bon
Slide 38: VMS Competitive Landscape
t dp VMS Competitive Landscape Sponsor / Manufacturer Development Phase Dose Form API Other Considerations DARE-HRT1 Daré Bioscience IND and Phase 3 preparations Monthly vaginal ring Bioidentical estradiol and progesterone Hormone therapy remains the most effective treatment for VMS and has been sho
Slide 39: DARE-PDM1: NSAID vaginal gel for female pelvic pain
Investigationa nonsteroidal anti- inflammatory drug (NSAID) vaginal gel for use in female pelvic pain A505(b)(2) regulatory pathway anticipated Pelvic pain in women is often overlooked and undertreated. While DARE-PDMz1 is currently being developed for regulatory approval for the indication of prima
Slide 40: 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 in
Slide 41: DIO
DIO IN ITALIAN, ITMEANS IN ENGLISH, IT MEANS =