Dare Bioscience, Inc. · NASDAQ:DARE
Dare Bioscience — Investor Presentation (January 2025)
39 slides from Dare Bioscience's investor presentation, Jan 13, 2025
Slide 1: Transforming Women's Health
January 13, 2025 l @ TRANSFORMING WOMEN’S HEALTH We founded Daré Bioscience with the sole focus of putting women’s health first -to boldly add feta merticgap women the novel pti y dd . IN ITALIAN, IT MEANS “TO GIVE.” IN ENGLISH, IT MEANS “TO BE BOLD.” d give J bioscience ©2025 Daré Bioscience | Allr
Slide 2: Forward-Looking Statements; Disclaimers
Forward-Looking Statements; Disclaimers " fon} : icitati iti é Bioscience, Inc. (“Daré” or the acompany) ial iintl int i i isti third icati doth Daré has not i fe d i In i may,” “will,” “expect,” “plan,” “anticipate,” “strategy,” “designed,” “could,” “intend,” “believe,” “estimate, target,” or “pote
Slide 3: Why invest in women?
Why invest in women? We believe that investment in women’s health will WOME ‘ Z be efficient and Limited R&D Investment Large Commercial Opportunity Only approximately 1% of Women’s health products healthcare research make up 27% of tota spending is invested in non- blockbuster products while oncolo
Slide 4: INNOVATION is:
INNOVATION is: when they talk about what th There's already a pill. So why are >40% of pregnancies inthe U.S. still unintended? Contraceptive Categories* Hormone-Free Options* F Cramping Barriers Heavy periods Not woman- Painful insertion controlled Women still lack options that fit their needs.
Slide 5: INNOVATION is:
INNOVATION is: Recognizing women’s health issues as ,not dismissing them as a “normal” part of life. = ‘© w Enlarged Chronic Back ww ww ydia Erectile sinoction Prostate Pain Dysfunction ' P Cervical HPV Painful Sex Infection leno, Urinary Incontinence "Let's "It just "Justa “Buy keep an happens bad
Slide 6: INNOVATION is:
INNOVATION is: Leveraging the learnings from existing therapeutics to gory pathway. 7 aT iT Tremale Sexual Sildenafil (oral) = arousal disorder a : Breast cancer Tamoxifen (oral) = sexual pain associated with menopaus' gi PY Ritonavir HIV (oral) => cancer Q £451 up 7 PI FDA approval. = - =! = = - >
Slide 7: Women's health-focused virtual care and new treatments
Women's health-focused Predicting virtual care platform pregnancy complications financing (2024) KINDBODY However, to truly transform women’s healthcare experience, the final pillar requiring investment is in the development of new safe and effective treatments.
Slide 8: We Are Leading Experts in Women's Health
D We Are Leading Experts in Women’s Health With a broad portfolio, we integrate clinical and regulatory Our commitment to strong relationshi Ps and and pro g trusted partner collaborators turnto for efficiency in developing impactful Deep w opportunities in women’s health lutions for women ca relati
Slide 9: 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 (mitlionsof US. PHASE3/ REGULATORY FDA ASSET! women) PRE-CLINICAL PHASE1
Slide 10: Daré's First FDA-Approved Product
4 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 (Clindamycin , Sa rimenele esl arell Collaborator -i3* ORGANO
Slide 11: Huge Gaps Remain in the Contraceptive Landscape
l D Huge Gaps Remain in the Contraceptive Landscape 6% of Americans currently © use a GLP-1(~20 million) 17 million ps.wonen hormonal contraception Current Non-Hormonal Users — Current Hormonal Users : We mi onue 1 women not seeking (Cando, withelrawal, spermicide) ei, Injectable, patch, rng, 35 mil
Slide 12: Fighting the Stigma Around Female Sexual Arousal Disorder (FSAD)
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 21to 60 are distressed from
Slide 13: When Fighting Stigma Becomes a Multi-Billion Dollar Industry
@ 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 HUMAN MALE ALFRED C KINSEY i Each male » However, there are still no FDA-approved treat
Slide 14: Menopause is Having a Moment
Menopause is Having a Moment + Th p tis ala g d i g market, with a be than 1 billi ted t 2025! Approximately 51% of menopausal women experience not flasnes. * The global market for menopausal products is growing rapidly, ata rate of more than 5%, rising from its 2021 level of about $15 billion to re
Slide 15: The Changing Perceptions Around Hormone Therapy (HT)
The C ng Perceptions Around Hormone Therapy (HT) Compounded "Bioidentical HT" women on d all Sul HT users in the U.S. 25 million’ Fromadne products* A generation of doctors and women are taught that HT is dangerous Without HT, many doctors are unsure of how to counsel menopausa patients on their sym
Slide 16: What Causes Menopause?
What Causes Menopause? Hormone therapy is recommended as the most effective treatment by th p for treatment of symptoms of p hot flashes. For VMS, the M p simultaneously, for i i i,and 5 | +, soe 4 potential advantages.” There are no FDA-approved products that combine both estradiol and progesterone
Slide 17: Safe and effective HPV treatments remain an unmet need
>6 million women While and screenings are diagnosed each year are important tools, safe and with high-risk HPV effective HPV treatments infections that could lead remain an unmet need. to cervical cancer.° Today, HPV infections are not treated upon diagnosis. This surgery is associated with an incre
Slide 18: Earlier Stage Programs with Grant Funding Enhance the Pipeline
D Australia R&D Cash Rebate Oi) DARE-PDM14 Pelvic Pain DARE 204/214 * 6 &12-Month Injectable Contraception DARE-FRT1/PTB1* Proterm birth (OARE-PTBI) and fortes! phase port as part of an IVF regimen (DARE-FRT1) DARE-LARC1% Long-Acting, Reversible Personal Foundation Grant As05(b)(2) regulatory pathwa
Slide 19: Upcoming Milestones
_Upcomin 2 = Phase 3 study enrollment ongoing = Phase 3 study updates « Phase 3 protocol submission reflecting the FDA’s recommendations planned for Q1 2025 = Phase 3 study start targeted for mid- 2025 Sildenafil Cream, 3.6% * Collaboration strategy = IND and Phase 2 study preparations, being suppor
Slide 20: Appendix
Slide 21: Daré Bioscience Corporate Highlights
novativ ducts for ealth and: .wellbeing of | women. allows the Company to pursue a portfolio approach with several potential commercial products under the Daré rella leveraging the 505(b)(2) pathway could accelerate clinical development timelines and allow the Company to advance programs in amore ca
Slide 22: Ovaprene: Investigational Monthly Hormone-Free Contraceptive
, 4 ka vestigatio ginal horm ee,monthly ntraceptive ase 3 contraceptive efficacy study Currently enrolling 2 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 mont
Slide 23: Ovaprene - Pre-Pivotal Study
l @ Ovaprene® - Pre-Pivotal Study The Ovaprene® Pre Pvetal Postcoital Test (PCT) study met its primary endpoi In 100% of women and seyetes, Ovaprene prevented the requisite number of sperm from reaching the cervix. A successful cycle was defined as an average of less than five (< 5) progressively mo
Slide 24: Ovaprene - U.S. Regulatory Strategy
l D 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. Pivotal study design? lead review division. * Thi
Slide 25: Ovaprene - Commercial License Agreement with Bayer
l @ Ovaprene® - Commercial License Agreement with Bayer B y Bayer, which kets the $1 per billion Mi i ise, and per E announced a4 Mirena? is the under which Bayer may Ovapren€ #1 prescribed ; ; ; j US once lUDinth approved by FDA’. We believe the licensing agreement with Bayer is validation of our b
Slide 26: Ovaprene - Potential U.S. Market Opportunity
l D Ovaprene® - Potential U.S. Market Opportunity*2 ion Women otential Candidates for 12 Million 12 Million < Current Non-Users Current Hormonal Product Users Currently use no contraception Pill (20, * Sexually active . net “ 6M) + Not seeking pregnancy inal Ring (2. Em wergeney contreception (0.03M
Slide 27: Daré's Potential First-in-Category Treatment for FSAD
as Daré’s Potential First-in-Category Treatment for Female =, Sexual Arousal Disorder (FSAD) 5 FSAD is characterized primarily by inability to attain or maintain 3 ke) ffici ital 1 duri g 1 activity. 53 o a FSAD should be distinguished | from other sexual disorders we characterized in the E32 desire
Slide 28: Path Forward for Sildenafil Cream
l @ Path Forward for Sildenafil Cream Key Takeaways- Phase 2b Clinical Study Clinical Development Pian anc Commercialization Opportunity Cream vs. placebo over 12 weeks. hare . T ‘ ‘ it ifi FSAD. j treatment OF FOAL. . isti - poet : ‘anit Sildenafil imp d (P j i Cream in the U.S. i + End-of. i i let
Slide 29: Oral Sildenafil provided a proof of concept for FSAD
Oral Sildenafil provided a compelling proof of concept for FSAD Amplitude (VPA)! ini fo} Mean and Maximum VPAt P=0.093 + Twelve healthy premenopausal women were studied. Observed Number Improved (4) Statistically significant improvement in genital stimulation (FIEI)? ical Fie Oral \ Improvement on F
Slide 30: Overview of Phase 2b Study
l .) Overview of Phase 2b Study Phase 2b, Exploratory, Randomized, PI bo-Controlled, Trial of i 6% for the Treatment of Over 10,000 women ‘ ‘i f Randomization ; A Patient No Drug RunIn Single Blind Placebo Run In : - d to Patient Screening Enrollment (4 Weeks) (4 Weeks) Double-blind enroll in the (1
Slide 31: Phase 2b - Exploratory Post-Hoc Analyses
l D Phase 2b - Exploratory Post-Hoc Analyses* Pp, t. Poet. 7 7 1 Post-Ho roposed F pop f 1 Ta or . FSAD with or y Sildenafil Placebo such Cream 3.6% Cream Endpoint (N=33) (N=32) P value f acti 1, 3.6% Idb LS change (SE) LS change (SE) m + Inthe ITT population, alth h isti BL to Week 12 BL to Week 12
Slide 32: Sildenafil Cream, 3.6%: Phase 1 and Phase 2a Study Results
I )) Sildenafil Cream, 3.6% Phase 1 and Phase 2a Study Results Thermography Study Results* 3.6%)! + Demonstrated time to effect (11-15 minutes) Sildenafil Cream, 3.6%, sildenafil dose: + AUC -3-6% * Cmax-1-2% 15 of th i 2g): vestibule. + Easytouse + Readily absorbed y 3.6%)! minutes post dosing Phas
Slide 33: What Causes Menopause?
l -) What Causes Menopause? During perimenopause, the supply of ggs ina woman’s soe diminich a lati A Th duct: Symptoms of Menopause ee ~ as of g estrogen in particular f th p menopause.! Memory Issues Dercuty concontatingor | SP y expertencing memory apes. Sleep Disturbances (for illustrative purpo
Slide 34: Daré Menopause Programs
l D Daré Menopause Programs Hormone Therapy Product Candidate DARE-HRT1 Monthly Vaginal Ring for the Vasomotor Symptoms of Menopause Phase 1/ 1 1 1 y ha: udy underway. rv) Bioidentical estradiol & progesterone in one product v) a ighly . 9 form + Inthe Ph1/2 study, DARE-HRT1 demonstrated y symp’ men
Slide 35: DARE-HPV: 505(b)(2) regulatory pathway
8506(6)(2) reguiatory pathway a i © 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 ina sof
Slide 36: Safe and Effective HPV Treatments Remain an Unmet Need
4 Safe and Effective HPV Treatments Remain an Unmet Need HPV is the most common sexually transmitted infection in the United States. >11 millionwomen Today, : acquire a new infection th halate st th phpeuienddananivhail” oi a HIGH-RISK HPV INFECTIONS surgery whi k the equi arcinoge s N (CARCINOGENIC
Slide 37: Pelvic pain in women is often overlooked and undertreated
Pelvic pain in women is often overlooked and undertreated. + While DARE-I urrently for reg y app indication of pri imary iod pain), NSAID: p ; i ic pai d by many gynecologic conditions. y F, ; Chronic pelvic pain in women An estimated isassociated with Dysmenorrhea affects up to 50-90% OF >6.5 MILLI
Slide 38: XACIATO Selected Safety Information
ll @ XACIATO Selected Safety Information IATOi indi in indivi i history of itivi lindamyci lincomycin. tated it h DAD) h h p | ;- rl] ly 1 j including clindamycin and n gei ity ild diarrhea to fatal 5 Careful medical history is necessary since CDAD h dt over fter the administ I Dis ae or confirmed,
Slide 39: DIO
DIO INITALIAN, IT MEANS = IN ENGLISH, ITMEANS (0 >>
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