Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (February 2025)
41 slides from Dare Bioscience's investor presentation, Feb 10, 2025
Slide 1: Transforming Women's Health
February 10, 2025 d 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 need and deserve. IN ITALIAN, IT MEANS “TO GIVE.” IN ENGLISH, IT MEANS “TO BE B
Slide 2: Forward-Looking Statements; Disclaimers
» 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 discusses potential future drug and medical device prod
Slide 3: Why invest in women?
HEALTH "An Efficien’ Why invest in women? 1 We believe that investment in women’s health will be efficient and Limited R&D Investment Only approximately 1% of healthcare research spending is invested in non- oncologic female conditions." The global healthcare pipeline is comprised of less than 2% of
Slide 4: About Us
4 “ ABOUT US At Daré, we believe women’s health deserves dramatically increased attention, investment and innovation. Some of the most persistent unmet needs in women’s health are not yet solved simply because companies have not taken the time to address them. That’s why we founded Daré with the sol
Slide 5: Innovation is listening to women's needs
INNOVATION is: when they talk about what they need. There's already a pill. So why are >40% of pregnancies in the U.S. still unintended? ' ncylindex. html Contraceptive Categories* Hormone-Free Options* Requires Crampin; Barriers Heavy Biricds Not woman- consistent daily inful inserti controlled tem
Slide 6: Innovation is recognizing women's health issues
INNOVATION is: Recognizing women’s health issues as ,not dismissing them as a “normal” part of life. Be DB Chlamydia Enlarged Chronic Back Erectile Infection Prostate Pain Dysfunction Cervical HPV Urinary Pelvic Pain Painful Sex Infection i tosis, Menopause, Lf» y~ Py Ww id Ww "Let's "It just “Buy k
Slide 7: Innovation is leveraging learnings from existing therapeutics
INNOVATION is: Leveraging the learnings from existing therapeutics to We deploy established active pharmaceutical ingredients (APIs) in first-in- category candidates, allowing us to leverage the derisked 505(b)(2) regulatory pathway. Erectile dysfunction = Topical treatment for female sexual Sildena
Slide 8: Investment in women's health companies and the need for new treatments
S14M aN MIRVIE Women's health-focused Series A Predicting virtual care platform (2024) canary E-Te] Mh complications Series B (2022) vaginal health $125M "e088" OOVA SeriesA JNaiIts [Cory fertility tracking Fertility financing clinic network Wasa KINDBODY Vv-TREATMEM However, to truly transform X |
Slide 9: We Are Leading Experts in Women's Health
l @ We Are Leading Experts in Women’s Health With a broad portfolio, we integrate clinical and regulatory insights to drive innovation and 8 successful Clinical Our commitment to strong relationships and proven results positions us as the trusted partner collaborators turn to for efficiency in devel
Slide 10: In Development at Daré
In Development at Daré The First Monthly Hormone-Free Vaginal Contraceptive The most common non-hormonal option used by women today is the copper IUD, which can cause severe cramping and heavy periods. Daré’s investigational contraceptive seeks to offers a hormone-free, self-controlled alternative t
Slide 11: Revolutionizing Women's Health Therapeutics
I D Revolutionizing Women’s Health Therapeutics Our investigational products are some of the most potentially disruptive therapeutic candidates for women in decades, targeting unmet needs with innovative solutions. ADDRESSABLE Gomerecim PHASE 3/ REGULATORY FDA ASSET! women) PRE-CLINICAL PHASE1 PHASE
Slide 12: Daré's First FDA-Approved Product
_ Daré’s First FDA-Approved Product In less than five years, Daré: In-licensed the asset with a 30-patient proof-of-concept study Completed the pivotal clinical trial Achieved FDA approval Ensured product supply to support the U.S. launch (Clinda mycin y Commercialization Collaborator -i3* ORGANON P
Slide 13: Huge Gaps Remain in the Contraceptive Landscape
l » Huge Gaps Remain in the Contraceptive Landscape We lieve that ons of women have not found the contraceptive option that meets th 6% of Americans currently © use a GLP-1(~20 million) 17 million U.S. women use hormonal contraception Current Non-Hormonal Users — Current Hormonal Users eonge 1 king
Slide 14: Fighting the Stigma Around Female Sexual Arousal Disorder
Fighting the Stigma Around 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. 1 6% of women in the U.S. ages 21 to 60 are distressed fro
Slide 15: When Fighting Stigma Becomes a Multi-Billion Dollar Industry
ll @ When Fighting Stigma Becomes a Multi-Billion Dollar Industry Before Viagra®, erectile dysfunction (ED) was also dismissed and stigmatized and often considered to be a normal part of aging. SEXUAL BEHAVIOR IN The American Journal of Medicine May 1986, Vol. 80 THE HUMAN MALE ALFRED C. KINSEY “[Ol
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 2025'. Approximately 51% of menopausal women experience moderate to severe vasomotor symptoms (VMS) or hot flashes.? The global market for menopau
Slide 17: Misconceptions Around Hormone Therapy
ons Around Hormone Therapy (HT) Compounded "Bioidentical HT” Non-HT Supplements for ; + The term "bioidentical HT" began Menopause Symptoms A generation of doctors and as a marketing term for custom- women are taught that HT is compounded hormones. * Often contain herbal dangerous. + Not FDA-approve
Slide 18: What Causes Menopause?
What Causes Menopause? Hormone therapy is recommended as the most effective treatment by the Menopause Society for treatment of the vasomotor symptoms of menopause (VMS) or hot flashes. For the treatment of VMS, the Menopause Society recommends delivering estrogen and progesterone, simultaneously, f
Slide 19: >6 million women diagnosed yearly with high-risk HPV
>6 million women are diagnosed each year with high-risk HPV infections that could lead to cervical cancer.’ Today, HPV infections are not treated upon diagnosis. While vaccinations and screenings are important tools, safe and effective HPV treatments remain an unmet need. HPV infections and cervical
Slide 20: Earlier Stage Programs with Grant Funding Enhance the Pipeline
» Earlier Stage Programs with Grant Funding Enhance the Pipeline Australia RED Cash Rebate | NIH) cia Foundation grant up to~$49M. Foundation Grant @ COPENHAGEN DARE-PDM14 Pelvic Pain DARE 204/214 4 6 &12-Month Injectable Contraception DARE-FRT1/PTB14 Preterm birth (DARE-PTBI) and for luteal phase s
Slide 21: Upcoming study milestones
= Phase 3 study enrollment ongoing = Phase 3 study updates = Phase 3 protocol submission reflecting the FDA’s recommendations planned for Q1 2025 Sildenafil Cream, 3.6% « Phase 3 study start targeted for mid- 2025 = Collaboration strategy = IND and Phase 2 study preparations DARE-HPV
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Slide 23: Daré Bioscience Corporate Highlights
allows the Company to pursue a portfolio approach with several potential commercial products under the Daré umbrella novative - q leveraging th ¢ ucts for 505(b)(2) oektanats our’ accelerate clinical development timelines and allow the Company to advance programs in amore capital efficient way compa
Slide 24: Ovaprene: Potential First-in-Category Contraceptive
_-Investigatio intravaginal hormo 1a ee, monthly ntraceptive ase 3 contraceptive efficacy study Currently 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-appr
Slide 25: Ovaprene - Pre-Pivotal Study
l @ Ovaprene® - Pre-Pivotal Study * The Ovaprene® Pre-Pivotal Postcoital Test (PCT) study Ovaprene® Pre-Pivotal Study Results met its primary endpoint. ; 80 * In100% of women and cycles, Ovaprene prevented the | 70 requisite number of sperm from reaching the cervix. FE © « Asuccessful cycle was defi
Slide 26: Ovaprene - U.S. Regulatory Strategy
l » Ovaprene® - U.S. Regulatory Strategy! Based on our communications to date with the FDA, if successful, we believe only this single ongoing registration study will be sufficient to support a premarket approval application submission* with the FDA. *Premarket approval (PMA) strategy; the Center fo
Slide 27: Ovaprene - Commercial License Agreement with Bayer
| @ Ovaprene® - Commercial License Agreement with Bayer January 2020 - Bayer, which markets the $1 BAYER billion Mirena contraceptive franchise, and Daré announced the execution of a license agreement Mircametetn under which Bayer may commercialize Ovaprene #1 prescribed investigational contraceptiv
Slide 28: Ovaprene - Potential U.S. Market Opportunity
D Ovaprene® - Potential U.S. Market Opportunity”? 35 Million Women Potential Candidates for Ovaprene® 32 Million aaiililiem Current Non-Users Current Hormonal Product Users Currently use no contraception + Pill(10.3M) * Sexually active + Injectable/patch (1.6M) Not seeking pregnancy Vaginal Ring (1.
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 should be distinguished from other se
Slide 30: Path Forward for Sildenafil Cream
! D Path Forward for Sildenafil Cream Key Takeaways- Phase 2b Clinical Study + The Phase 2b Clinical Study was designed to evaluate Sildenafil Cream vs. placebo over 12 weeks. + To Daré’s knowledge, this was the first study specifically evaluating a potential therapy for treatment of FSAD. + Post-ho
Slide 31: Oral Sildenafil provided a proof of concept for FSAD
l » Oral Sildenafil provided a compelling proof of concept for FSAD ignificant i in genital - - — stimulation (FIEN)? + Question #2 - “After taking study medication, the Pfizer Clinical Field Study - Oral Viagra sensation/feeling in my genital (vaginal, labia, clitoris) area during intercourse or st
Slide 32: Overview of Phase 2b Study
l .) 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 7 q Rand
Slide 33: Phase 2b - Exploratory Post-Hoc Analyses
l D Phase 2b - Exploratory Post-Hoc Analyses* Post-Hoc Analysis Results from Proposed Phase 3 population: + Post-hoc analyses were conducted on enrolment FSAD with or without concomitant decreased desire female sexual dysfunction diagnosis category so that efficacy could be evaluated in the study su
Slide 34: Sildenafil Cream, 3.6% Phase 1 and Phase 2a Study Results
I ) 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 35: What Causes Menopause?
! -) What Causes Menopause? During perimenopause, the supply of mature eggs in a woman’s ovaries diminishes and ovulation becomes irregular. The production Symptoms of Menopause 9g Proc of estrogen and progesterone also decreases. The changes in estrogen in particular cause most of the symptoms of m
Slide 36: Daré Menopause Programs
d 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.* iv) Bioidentical estradiol & progesterone in one product rv) Highly accep
Slide 37: DARE-HPV
“ *506(b)(2) regulatory pathway anticipated, a © 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 rito
Slide 38: Safe and Effective HPV Treatments Remain an Unmet Need
q Safe and Effective HPV Treatments Remain an Unmet Need HPV-Related Cervical Diseases per year in the U.S.’ + HPV is the most common sexually transmitted infection in the United States. >11 million women A acquire a new infection + Today, cervical precancers (dysplasia) are monitored until they rea
Slide 39: Pelvic pain in women is often overlooked and undertreated
Pelvic pain in women is often overlooked and undertreated. While DARE-PDM1 is currently being developed for regulatory approval for the indication of primary dysmenorrhea (period pain), NSAIDs are a key component to the multimodal treatment approaches for pelvic pain caused by many gynecologic condi
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 ran
Slide 41: DIO
DIO IN ITALIAN, ITMEANS IN ENGLISH, IT MEANS =
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