UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 5, 2018
DARÉ BIOSCIENCE, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36395 | 20-4139823 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
3655 Nobel Drive, Suite 260
San Diego, CA 92122
(Address of Principal Executive Offices and Zip Code)
Registrant’s telephone number, including area code: (858) 926-7655
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 8.01 | Other Events. |
Included as Exhibit 99.1 to this report is a presentation about Daré Bioscience, Inc. (“Daré”) and its product candidates, dated September 5, 2018, which is incorporated herein by reference. Daré intends to use the presentation and its contents in various meetings with investors, securities analysts and others, commencing on September 5, 2018.
By filing this report, including the information contained in Exhibit 99.1 attached hereto, Daré makes no admission as to the materiality of any information in this report. The information contained in Exhibit 99.1 hereto is summary information that is intended to be considered in the context of Daré’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K filed on March 28, 2018 (as amended by the Form 10-K/A filed on April 30, 2018), Quarterly Reports on Form 10-Q filed on May 14, 2018 and August 13, 2018, and other public announcements that Daré makes, by press release or otherwise, from time to time. Daré undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as it believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases, or through other public disclosure.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description | |
| 99.1 | Corporate presentation, dated September 5, 2018 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| DARÉ BIOSCIENCE, INC. | ||||||
| Dated: September 5, 2018 | By: | /s/ Sabrina Martucci Johnson | ||||
| Name: | Sabrina Martucci Johnson | |||||
| Title: | President and Chief Executive Officer | |||||
Delivering innovation by daring to be different September 5, 2018 Exhibit 99.1
Forward Looking Statements 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 STATISTICAL SERVICES, THIRD PARTY PUBLICATIONS, AND OTHER SOURCES. DARÉ HAS NOT INDEPENDENTLY VERIFIED SUCH INFORMATION AND THERE CAN BE NO ASSURANCE AS TO ITS ACCURACY. ALL STATEMENTS IN This presentation, OTHER THAN STATEMENTS OF HISTORICAL FACT, ARE forward-looking statements within the meaning of federal securities laws. IN SOME CASES, YOU CAN IDENTIFY FORWARD-LOOKING STATEMENTS BY TERMS SUCH AS “MAY,” ”WILL,” “EXPECT,” “PLAN,” “ANTICIPATE,” “Strategy,” “designed,” “COULD,” “INTEND,” “BELIEVE,” “ESTIMATE,” “Target,” OR “POTENTIAL” AND OTHER SIMILAR EXPRESSIONS, OR THE NEGATIVE OF THESE TERMS. Forward-looking statements involve risks, uncertainties and assumptions that may cause DARÉ’S actual results, performance or achievements to be materially different from THOSE expressed or implied by the forward-looking statements, INCLUDING, WITHOUT LIMITATION risks and uncertainties relating to: the outcome or success of clinical trials; DARÉ’s ability to raise additional capital as needed; DARÉ’s ability TO OBTAIN AND MAINTAIN INTELLECTUAL PROPERTY PROTECTION FOR ITS PRODUCT CANDIDATES; DARÉ’S ABILITY TO DEVELOP product candidates ON THE TIMELINEs set forth HEREIN; and other risk factors described in DARÉ’s most recent annual report on form 10-K and quarterly report on form 10-q filed with the Securities and Exchange Commission. All forward-looking statements in this presentation are current only as of the date hereof and DARÉ does not undertake any obligation to update any forward-looking statement to reflect new information, future developments or otherwise, except as required by law.
Vision: To become the coordinating presence in women’s health. Mission: We achieve this by identifying, unlocking and advancing innovation that improves health outcomes and promotes a better quality of life for women. Vision & Mission
Daré Highlights Daring to be different A pure play biopharmaceutical company focused on improving the health and well being of women. Focused on targeted delivery of products to address persistent unmet needs in women’s health: Pregnancy Prevention Sexual Health Vaginal Health Fertility The portfolio is well positioned to drive upside value in the short and long term and each asset is positioned to be a first-in-category opportunity. Multiple milestones and value drivers expected over the next 12 - 24 months: Advancing our two Phase 2 programs, and Initiating development activities on Phase 1 and preclinical programs.
Coordinating Innovation in Women’s Health Daré is building a strong and strategic network to advance innovation in women’s health. Global Women's Health Market Worth $51 Billion by 2025 - CAGR: 3.9% 1 1. https://www.prnewswire.com/news-releases/womens-health-market-size-worth-513-billion-by-2025--cagr-39-grand-view-research-inc-651064753.html Women’s Health Network of Product Developers Women’s Health Network of Potential Commercial Partners* Strategic Science & Technologies *Company names and logos are for illustrative purposes only.
Portfolio Overview Timeline reflects management’s current estimates and constitutes a forward looking statement subject to qualifications elsewhere in the presentation. Actual development timeline may be substantially longer, and Daré is under no obligation to update or review this estimate. CDRH / Device Lead Innovative Women’s Health Pipeline ^505(b)(2). *Ovaprene Post Coital Test (PCT) is a pre-pivotal clinical study.. ‡HRT Phase 1 study to be conducted in Australia by Daré subsidiary. Ovaprene® (PCT)* Topline 2H 2019 Pregnancy Prevention (Contraception) Topical 5% Sildenafil Citrate Cream Topline 4Q 2020 Female Sexual Arousal Disorder DARE-HRT1^‡ Topline 2H 2019 Hormone Replacement Therapy Formerly JNP-0201 DARE-FRT1^ Preterm Birth / Infertility (IVF) Formerly JNP-0301 DARE-OAB1^ Overactive Bladder Formerly JNP-0101 DARE-VVA1^ Vulvar Vaginal Atrophy Formerly PT-101 DARE-RH1 Contraception Formerly CatSper ORB 204 & 214^ Contraception Topical Cream sildenafil IVR estradiol + progesterone Vaginal Insert SERM IVR natural progesterone IVR oxybutynin Injectable sustained release etonogestrel Barrier IVR ferrous gluconate Ca2+ Target
1. Global Market Insights, https://globenewswire.com/news-release/2016/05/19/841462/0/en/Contraceptives-Market-size-to-exceed-33-Billion-by-2023-Global-Market-Insights-Inc.html Contraception $32 billion global category1
Innovation in Contraception Advances in hormone products have largely focused on reducing the hormone dosage, adjusting or extending the duration of protection and optimizing methods of administration. Convenience is driving new innovation NuvaRing® Monthly, convenient vaginal ring product form. 2017 revenue: $761 million (Merck).5 Mirena® Physician inserted, long-acting. Low/locally delivered hormone IUS. 2017 revenue: $1.12 billion (Bayer).5 What’s Driving Innovation in Contraception 1. Lo Loestrin Fe contains a low-dose combination of two female hormones. https://www.loloestrin.com/loloestrin/about-lo-loestrin. Lo Loestrin® and its design are registered trademarks of Allergan Pharmaceuticals International Limited. 2. Minastrin https://www.minastrin24.com. Minastrin® is a registered trademark of Allergan Pharmaceuticals International Limited. 3. https://www.nuvaring.com/how-nuvaring-works/ 4. https://www.mirena-us.com/about-mirena/ 5. 2017 SEC Financial Filings 1 2 3 4
The US Contraceptive Market is Large >$6 billion in US Rx sales of contraceptive products (2016).1 40 million women of reproductive age currently use a contraceptive method.2 Ready for Innovation 4 in 10 women not satisfied with their current method.2 ~50% of women opting for a shorter-acting reversible method.3 Limited product mix in the OTC non-hormonal contraceptive category Most non-hormonal options are over the counter (OTC) and are not optimal in terms of effectiveness or convenience. Largest SKUs in the OTC channel are condoms and Plan-B.4 U.S. Contraceptive Market $6 Billion IMS NSP through Dec 2016 www.guttmacher.org, contraceptive fact sheet Ersek, J, Matern Child Health J (2011) 15:497–506 IRI Data
Women’s Preferences Effective Pregnancy Prevention Convenient Product Forms Independent surveys revealed that the vaginal ring has many of the features women deemed extremely important.1 Less Hormones A majority of women prefer a monthly option with a lower hormone dose than the pill.2 Methods not in the moment (noncoital) 75% of women who practice contraception currently use non-coital (not in the moment) methods.3 What Women Want from Birth Control Lessard, L,Perspectives on Sexual and Reproductive Health, Volume 44, Number 3,9-2012 Hooper, DJ, Clin Drug Investig. 2010;30(11):74963 https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states
Non-hormonal Products (marketed or in development) Spermicides / vaginal gels Least effective woman controlled. On-demand / pre-coital application. Condoms Effective, not woman controlled. On-demand / pre-coital application. Diaphragms Most effective woman controlled. On-demand / pre-coital insertion. Long-acting IUD Most effective. Requires physician insertion/removal. What’s Driving Innovation in Contraception Innovation in Contraception - What’s Missing? Non-hormonal, non-coital alternatives that are effective and easy to use. 100% Effective = 0% Risk of Pregnancy / vaginal gels Trussell J. Contraceptive Efficacy. In Hatcher RA, Trussell J, Nelson AL, Cates W, Kowal D, Policar M. Contraceptive Technology: Twentieth Revised Edition. New York, NY: Ardent Media, 2011. http://www.contraceptivetechnology.org/wp-content/uploads/2013/09/CTFailureTable.pdf 1 1,2 A non-hormonal, non-daily, woman controlled option with efficacy approaching traditional hormonal methods aligns well with consumer need states.
Ovaprene® A New Contraceptive Opportunity Monthly Non-Hormonal Opportunity
Ovaprene® Non-hormonal, Monthly Vaginal Ring Spermiostatic Environment1 Achieved through a contraceptive-loaded silicone ring matrix. Releasing non-hormonal active Ferrous gluconate. Physical Barrier1 3-D, non-braided, fluid-permeable mesh barrier. Rx distribution (OB/GYN) – anticipated upon approval. Patent Protection1 12 issued patents worldwide (9 U.S.). IP coverage through August 2028. Potential extension to 2033. 1. Data on file Ovaprene® A New Contraceptive Opportunity
2009 - Postcoital Assessment:1 Open-label, single-arm, pilot safety and tolerability study. Published in the Journal of Reproductive Medicine, 2009. Patients: N= 21; all women completed one cycle of use. Results: Postcoital testing revealed no viable sperm in the cervical mucus. No colposcopic abnormalities, no significant changes in vaginal flora and no serious adverse effects observed. Ovaprene® Non-hormonal, Monthly Vaginal Ring Ovaprene successfully prevented sperm from reaching the cervical canal in a previous human postcoital test (PCT) clinical study. In PCT studies of similar size, products (diaphragms) with no motile sperm in the cervical mucus during their PCT assessments demonstrated “typical use” contraceptive effectiveness of 88% in pivotal contraceptive studies evaluating pregnancy rates over time. Journal of Reproductive Medicine 2009; 54: 685-690 Trussell J. Contraceptive Efficacy. In Hatcher RA, Trussell J, Nelson AL, Cates W, Kowal D, Policar M. Contraceptive Technology: Twentieth Revised Edition. New York, NY: Ardent Media, 2011. http://www.contraceptivetechnology.org/wp-content/uploads/2013/09/CTFailureTable.pdf 2,3 Ovaprene® A New Contraceptive Opportunity
Step 1 – Postcoital test (PCT) 2018 / 2019* The study is enrolling 50 couples. 25 women complete a total of 21 visits Evaluated over the course of five menstrual cycles. Each woman’s cervical mucus will be examined at several points during the study: Cycle 1 - Baseline (excludes the use of any product), Cycle 2 – Use of a barrier method (diaphragm), Cycles 3,4 and 5 - Ovaprene vaginal ring. Assess motile sperm per high powered field (HPF) in the cervical mucus, post coitus. Safety assessments, PK, acceptability, fit, and ease of use. *Anticipated regulatory pathway and timelines. Daré has not had any communications with the FDA regarding the specific PMA requirements for Ovaprene. Ovaprene® Non-hormonal, Monthly Vaginal Ring U.S. Regulatory Strategy PMA with CDRH (Medical Device Division) as lead review division. Pathway expected to be based on similar CDRH approvals - Example: Caya® diaphragm.* Step 2 – Pivotal Study 2020 / 2021* Single pivotal clinical (expected). N= ~250 completers over 6 months of use. Primary Endpoints: Safety & Efficacy Pregnancy probability. Secondary Endpoints: Acceptability /product fit/ ease of use. Assessments of vaginal health. Ovaprene® A New Contraceptive Opportunity Data from the study is expected to be available in the second half of 2019. If there is demonstration of feasibility in the PCT clinical trial, the Company intends to prepare and file an Investigational Device Exemption (IDE) with the FDA to commence a pivotal clinical trial to support marketing approvals of Ovaprene in the United States, Europe and other countries worldwide.
https://www.urban.org/urban-wire/women-want-effective-birth-control Lessard, L,Perspectives on Sexual and Reproductive Health, Volume 44, Number 3,9-2012 Hooper, DJ, Clin Drug Investig. 2010;30(11):74963 Ersek, J, Matern Child Health J (2011) 15:497–506 Journal of Reproductive Medicine 2009; 54: 685-690 Features Desired Most in Birth Control:1-4 Design Features of Ovaprene:5 Convenience (Easy to Use & Easy to Remember) Monthly Ring Product Form Women chose rings for the convenience of a non-daily option. Hormone Free No Hormones in the API Unique dual action MOA (spermiostatic & barrier). Efficacy Potential for Contraceptive Effectiveness at the Lower End of the Hormone Contraceptive Range. Favorable Side Effect Profile No Colposcopic Abnormalities No significant changes in vaginal flora. No serious adverse effects observed in prior published study. Easily Manage Fertility No Systemic Activity Inserted and removed without a provider. Immediate return to fertility. Ovaprene® A New Contraceptive Opportunity Ovaprene® Non-hormonal, Monthly Vaginal Ring
1. https://www.visiongain.com/Press_Release/911/Sexual-dysfunction-drugs-market-will-reach-7-7bn-in-2019 Female Sexual Arousal Disorder (FSAD) World market for both male and female sexual dysfunction drugs will reach 7.7 billion in 20191 Women’s Sexual Health & Wellness
Vulvar-Vaginal Atrophy Female Sexual Arousal Disorder (FSAD) Dyspareunia Hypoactive Sexual Desire Disorder (HSDD) Female Sexual Dysfunction (FSD) With its approval of Addyi®, FDA has now acknowledged and formally classified the distinct and separate disorders that comprise Female Sexual Dysfunction. Where HSDD is characterized primarily by a lack of sexual desire, FSAD is characterized primarily by an inability to attain or maintain sufficient physical sexual arousal. Female Sexual Dysfunction Market Landscape No Approved Products INTRAROSA is a registered trademark of Endoceutics, Inc. Imvexxy is a trademark of TherapeuticsMD, Inc. Osphena is a registered trademark of Duchesnay USA, Pennsylvania, USA. ESTRACE® is a registered trademark of Allergan Pharmaceuticals International Limited. Premarin is a registered trademark of Pfizer Inc. Addyi is a registered trademark of Sprout Pharmaceuticals, Inc. Bremelanotide is a registered trademark of Palatin Technologies, Inc.
Female Sexual Arousal Disorder (FSAD) FSAD is characterized primarily by an inability to attain or maintain sufficient physical sexual arousal; it is also characterized by distress or interpersonal difficulty.* Estimated 23-33% of women suffer from arousal disorder: Meta-analysis of 95 studies from 2000-2014 indicated the prevalence of Female Sexual Dysfunction in premenopausal women worldwide is 40.9%, and difficulty with arousal alone is 23%.1 33% of women in the U.S. age 21 to 60 (approximately 20 million women), experience symptoms of low or no sexual arousal.2,3 10 million women are considered distressed and actively seeking treatment.2 Female Sexual Arousal Disorder FSAD McCool et al. Sex Med Rev 2016;4:197-212. Ad Hoc Market Research: FSAD Prevalence Report (Oct 2015) conducted for SST LLC. Based on US Census projections for 2016. *Diagnostic and Statistical Manual 4th Edition Text Revision (DSM IV TR), defines female sexual arousal disorder as a persistent or recurrent inability to attain or to maintain until completion of the sexual activity, an adequate lubrication-swelling response of sexual excitement. The diagnostic criteria also state that the inability causes marked distress or interpersonal difficulty, is not better accounted for by another Axis I disorder (except another sexual dysfunction), and is not due exclusively to the direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general medical condition.
Female Sexual Arousal Disorder (FSAD) Daré licensed the rights to Topical 5% Sildenafil Citrate Cream in February, 2018 for all women’s health indications related to female sexual dysfunction and female reproductive health. In a Phase 2a study, Topical 5% Sildenafil Citrate Cream formulation demonstrated an increase in blood flow to the vaginal tissue in both pre- and postmenopausal women with FSAD. Topical 5% Sildenafil Citrate Cream FSAD
† Twelve healthy premenopausal women were studied. P<0.05 P=0.093 P=0.015 P=0.017 † Question #2 – “After taking study medication, the sensation/feeling in my genital (vaginal, labia, clitoris) area during intercourse or stimulation (foreplay) seemed to be: (a) more than before, (b) less than before, or (c) unchanged”. Question #4 – “After taking the study medication, intercourse and/or foreplay was: (a) pleasant and satisfying; better than before taking the study medication, (b) unpleasant; worse than before taking study medication, (c) unchanged; no difference, or (d) pleasant; but still not like it used to be or I would like it to be.” 202 postmenopausal women with FSAD who had protocol specified estradiol and free testosterone concentrations, and/or were receiving estrogen and/or androgen replacement therapy were studied. Pfizer VPA Clinical Lab Study – Oral Viagra® Pfizer Clinical Field Study – Oral Viagra® Pfizer Viagra® Studies Increased Blood Flow and Clinical Efficacy with Oral Sildenafil in Women Female Sexual Arousal Disorder (FSAD) Sildenafil Demonstrated Statistically Significant Results Statistically significant increases in Vaginal Pulse Amplitude (VPA)1 Statistically significant improvement in genital stimulation (FIEI)2 Female Intervention Efficacy Index (FIEI) The Enhancement of Vaginal Vasocongestion by Sildenafil in Healthy Premenopausal Women. Journal of Women’s Health & Gender-Based Medicine. Vol. 11, No. 4. 2002 Safety and Efficacy of Sildenafil Citrate for the Treatment of FSAD: A Double-Blind, Placebo Controlled Study. The Journal of Urology. Vol 170, 2333-2338, December 2003.
Female Sexual Arousal Disorder (FSAD) Topical 5% Sildenafil Citrate Cream – Formulation Innovation Topical 5% Sildenafil Citrate Cream designed to directly increase local blood flow to the genital tissue. Localized action, with minimal systemic uptake of the active drug.1 6 issued patents in the U.S. on the topical delivery of Sildenafil and other PDE-5 inhibitors. Leveraging the known therapeutic benefit of oral sildenafil to stimulate increased blood flow to the genital tissue. If approved, Topical 5% Sildenafil Citrate Cream may offer a safe, effective and ‘on demand’ solution to difficulties with sexual arousal. SST Formulation Technology 1. Data on file Topical 5% Sildenafil Citrate Cream FSAD
Female Sexual Arousal Disorder (FSAD) TYPE C Meeting, 3Q 2018–our meeting goals: 1.Align with the agency on key aspects of the Phase 2b and the overall clinical program to support the planned NDA, including the patient reported outcome (PRO) assessments used to accurately diagnose FSAD, and the PRO instruments to be used as primary efficacy endpoints for pivotal clinical studies, study duration, and the target patient population to be studied. 2. Review nonclinical and clinical information available to date and begin dialogue to determine what else may be required to support the conduct of the planned Phase 2b multiple-dose efficacy and safety clinical study and overall NDA. Topical 5% Sildenafil Citrate Cream FSAD
Female Sexual Arousal Disorder (FSAD) Primary Endpoints for Phase 2b: While the 2016 Draft Guidance1 on arousal disorder discusses the use of the Female Sexual Function Index (FSFI) arousal questions as a possible PRO instrument for evaluating arousal improvement ─ and suggests for FSAD co-primary endpoints of improvement in satisfactory sexual events and arousal ─ the agency is open to considering an alternative approach. A tangible result of our meeting was the agency’s receptivity to our proposal that the co-primary endpoints assess the most important and relevant symptoms of the disorder – lack of genital sensations of arousal (an adequate lubrication-swelling response of sexual excitement) and personal distress. We believe the agency is receptive to our alternative approach because of its openness to collaborate with drug development companies to establish reliable patient-reported outcome measures capable of discerning the effectiveness of the product being investigated for the indication. We agreed that our Phase 2b program should commence with a content validity study to demonstrate that the symptoms we plan to assess are the most important and relevant to our target population. Because our plan is for the endpoints used in the Phase 2b to reflect the endpoints used in the Phase 3 trials, after the qualitative study is completed and before the Phase 2b at-home trial is initiated, we will request a Type C meeting to get feedback on whether the agency agrees that the PRO instruments are content valid for the target population. Topical 5% Sildenafil Citrate Cream FSAD The 2016 Draft Guidance for Industry –Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment (the 2016 Draft Guidance)
Female Sexual Arousal Disorder (FSAD) Length of study: The agency is agreeable to a 12-week Phase 2b trial to assess reasonable safety and preliminary efficacy. The 2016 Draft Guidance specifies 24 weeks for each of the two Phase 3 trials. Patient population: The agency confirmed that the 2016 Draft Guidance reflects its expectations regarding patient population to be studied (menopause status and concomitant conditions). Inclusion and exclusion criteria should reflect the population anticipated to use the drug, if approved. Further, the FDA reiterated its position that efficacy should be established separately in pre- and post-menopausal women to enable an adequate benefit/risk determination. As noted in the 2016 Draft Guidance, sponsors can choose to study pre- and postmenopausal women in separate trials or study these populations within the same trial, however, efficacy should be demonstrated for each group. In summary: We will commence Phase 2b related activities this year, as planned, with the initiation of the content validity PRO study, In parallel, we will continue to explore additional clinical and non-clinical work that might be valuable or required to support the overall program and the anticipated design of the Phase 2b, We plan to have follow up communications with the agency, as requested, that specifically address the adequacy of the data package generated before initiating the Phase 2b at-home trial. Topical 5% Sildenafil Citrate Cream FSAD
Vulvar-Vaginal Atrophy Female Sexual Arousal Disorder (FSAD) Dyspareunia Hypoactive Sexual Desire Disorder (HSDD) Female Sexual Dysfunction (FSD) With its approval of Addyi®, FDA has now acknowledged and formally classified the distinct and separate disorders that comprise Female Sexual Dysfunction. Where HSDD is characterized primarily by a lack of sexual desire, FSAD is characterized primarily by an inability to attain and/or maintain sufficient physical sexual arousal. Female Sexual Dysfunction Market Landscape INTRAROSA is a registered trademark of Endoceutics, Inc. Imvexxy is a trademark of TherapeuticsMD, Inc. Osphena is a registered trademark of Duchesnay USA, Pennsylvania, USA. ESTRACE® is a registered trademark of Allergan Pharmaceuticals International Limited. Premarin is a registered trademark of Pfizer Inc. Addyi is a registered trademark of Sprout Pharmaceuticals, Inc. Bremelanotide is a registered trademark of Palatin Technologies, Inc.
$32 billion global category* Innovative Vaginal Drug Delivery Well characterized therapeutic options
Features of the Juniper intravaginal ring technology include: Sustained drug delivery. Variable dosing and duration. Single or multiple drug delivery via a solid ethylene vinyl acetate polymer matrix (without the need for a membrane or reservoir to contain the active drug or control the release). Current 505(b)(2) candidates licensed from Juniper include: DARE-OAB1 Formerly JNP-0101, an oxybutynin ring for the treatment of overactive bladder; DARE-HRT1 Formerly JNP-0201, a combination estradiol + progesterone ring for hormone replacement therapy. DARE-FRT1 Formerly JNP-0301, a natural progesterone ring for the prevention of preterm birth and for fertility support as part of an IVF treatment plan. IVR Technology http://www.ibtimes.com/robert-langer-top-mit-biomedical-engineer-father-30-companies-how-launch-successful-2141263 https://reproendo.mgh.harvard.edu/programs/research-investigators/dr-william-crowley/ Daré has an exclusive, global license to Juniper’s novel IVR technology originally developed by Dr. Robert Langer from MIT and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. Intravaginal Ring (IVR) Technology Platform Daré’s exclusive license covers all rings in development as well as additional applications of the intravaginal ring technology platform in other therapeutic areas.
HRT Market Overview Hormone Replacement Therapy (HRT) Hormone therapy (HT) remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM) and has been shown to prevent bone loss and fracture.1 45M women in U.S. approaching or in menopause.2 2012 NAMS consensus statement supports HRT in peri- and post-menopausal women.3 NAMS recommends Non-oral route over oral.3 ~$1.5 B Compounded $660M FDA-approved The 2017 hormone therapy position statement of The North American Menopause Society; Menopause: The Journal of The North American Menopause Society Vol. 24, No. 7, pp. 728-753 U.S. Census Bureau, Population Division. Table 2. 2015 to 2060 (NP2012-T2). Released Dec. 2012. Menopause, Vol. 19, No. 3, 2012. U.S. 2014. Source: Symphony Health Solutions Report
DARE-HRT1 Phase 1 Overview Hormone Replacement Therapy (HRT)1 For Treatment of Vasomotor Symptoms due to Menopause 1. Data on file Proposed Study: A Phase 1, Open-Label, 3-arm Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 (80 µg and 160 µg Estradiol/ 5 mg and 10 mg Progesterone Intravaginal Rings) in Healthy Post-Menopausal Women. Primary Objectives: To describe the PK parameters over 28 days using two different dose combinations of DARE-HRT1 Intravaginal ring (IVR): Estradiol 80 µg/Progesterone 5 mg IVR Estradiol 160 µg/Progesterone 10 mg IVR Identify the steady-state PK after 28 days of each DARE-HRT1 N=60
Vaginally Delivered Tamoxifen to treat VVA in HR+ Breast Cancer Patients DARE-VVA1 (Formerly PT-101) A proprietary vaginal formulation of tamoxifen, has the potential to be a first-in-class treatment for vulvar and vaginal atrophy (VVA) in patients with hormone-receptor-positive (HR+) breast cancer. VVA is a chronic condition characterized by pain during intercourse, vaginal dryness and irritation. Most women use localized estrogen therapy which is contraindicated for more than two million women diagnosed with, or at risk of recurrence of, ER-positive and PR-positive breast cancer.1 Daré intends to develop this novel local application of tamoxifen to mitigate the symptoms of VVA for patients with or at risk for hormone-receptor-positive breast cancer, including women currently on anti-cancer therapy. Due to the use of aromatase inhibitors for the treatment of HR+ breast cancer, the prevalence of VVA in postmenopausal breast cancer patients is reported to be between 42 and 70 percent.2 If approved, DARE-VVA1 has the potential to be the first treatment specifically developed for VVA in patients with hormone-receptor positive breast cancer. DARE-VVA1 Vaginally Delivered Tamoxifen for VVA https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2800285/#S16title Clinical Breast Cancer: https://www.sciencedirect.com/science/article/pii/S1526820917300952
$32 billion global category* Strategic Pre-Clinical Candidates Contraceptives that address global gaps
Dare’s Innovation Engine Reproductive Health Public & Private Sector Funding "Innovative partnerships increase access to family planning, helping more women plan their lives and shape their futures.” Chris Elias, President Global Development Program, Bill & Melinda Gates Foundation Major foundations contribute hundreds of millions of dollars to fund new innovation in women’s reproductive health. Daré has emerged as the coordinating presence among these organizations and is well positioned to partner on the product candidates with significant market potential. Development organizations screen and advance promising new innovation.
Organization Funding Source / Donor Product Name License Holder / Partner Form Indication Annual Sales / Corporate Value1 The Population Council USAID Gates Foundation Therapeutics MD Ring Pregnancy Prevention $20M upon FDA approval; $20M first commercial batch, milestones + royalties 2018 USAID Paragard Cooper Surgical IUD Pregnancy Prevention Cooper Surgical $1.1B Acquisition from Teva 2017 USAID Mirena Bayer IUS Pregnancy Prevention >$1.1B (Global sales) 2018 USAID Jadelle Bayer Implant Pregnancy Prevention ~$400M (Global sales) Medicines360 Large Anonymous Donor Liletta Allergan IUS Pregnancy Prevention $50M upfront; $125M milestones + royalties, 2013 Value Creation in Women’s Reproductive Health Addressing Global Gaps in Contraception 1 SEC Filing/IMS Data Annovera
DARE-RH1 (CatSper) A Novel Approach To Male And Female Contraception. The identification of the CatSper target represents the potential to develop a novel class of non-hormonal contraceptive products for both men and women. The discovery of a sperm-specific ion channel, CatSper, was validated in animal models where it was demonstrated that male mice lacking CatSper have poor sperm motility. CatSper proteins are ion channels expressed solely in the membranes of sperm flagellum and are essential to sperm motility. Pre-clinical research has demonstrated CatSper mediates hyperactive motility of sperm. Sperm hyperactivity is necessary to penetrate the physical barrier known as the zona pellucida which encloses the ovum and protects the egg.1 The contraceptive benefit of targeting CatSper is achieved by inhibiting sperm hyperactivity and preventing egg fertilization. DARE-RH1 CatSper Contraception http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0028359
ORB-204 and ORB-214, injectable etonogestrel1 The initial development on Orbis’ long-acting injectable contraceptive program was carried out under a subcontract funded by Family Health International (FHI 360) through a grant from the Bill & Melinda Gates Foundation. Pre-clinical studies for the 6- and 12- month formulations have been completed to date: Establishing pharmacokinetics and pharmacodynamics profiles. An injectable contraceptive is designed to provide discreet, non-invasive protection over several months Limitations of the currently marketed injectable contraceptive: provides contraceptive protection for only three months, and can delay the ability to get pregnant for up to ten months after receiving the injection. Target product profile of long-acting injectable Prolonged duration (6 to 12 months), improved ease of use, with an improved side effect profile and predictable return to fertility. Long-acting Injectable Contraception 1. Data on file
Investment Highlights
Background NASDAQ:DARE Publicly traded via reverse merger that closed July 19, 2017. Balance sheet, June 30, 2018: $12.4 million in cash. Non-dilutive NIH SBIR Award (Q2-2018): Daré received a Notice of Award for the first $224,665 of an anticipated $1.9 million in grant funding 11.4 million in common shares and 3.7 million warrants No debt. Financial Profile
Sabrina Martucci Johnson, MSc, MIM President and CEO Cypress Bioscience, WCG Advanced Tissue Sciences, Baxter Healthcare Lisa Walters-Hoffert Chief Financial Officer ROTH Capital Partners, Citicorp Securities, Bank of America, Oppenheimer & Co. David Friend, PhD Chief Scientific Officer Evofem Biosciences, CONRAD, Elan Corporation John Fair, MA Chief Business Officer Evofem Biosciences, WCG, Gemini Healthcare, NPA Mark Walters Vice President, Operations Pacira, SkyePharma, Alliance Pharmaceuticals, American Home Products Mary Jarosz, RPh, RAC, FTOPRA Global Head of Regulatory Affairs Evofem Biosciences, WCG, Abbott Laboratories Christine Mauck, MD, MPH Medical Director CONRAD, Population Council, RW Johnson, FDA Bridget Martell, MD, MA Medical Affairs Juniper Pharmaceuticals, Purdue Pharma, Pfizer Nadene Zack, MSc Sr. Director Clinical Operations Retrophin, Aragon, Cypress Bioscience, Pfizer Experienced Team to Move the Field Forward
Experienced Board of Directors Roger Hawley (Chairman) Zogenix, Alios Biopharma, InterMune, Elan Corporation Susan Kelley, MD Cerulean, Bayer, BMS, ArQule William Rastetter, PhD Cerulean, GRAIL, Receptos, Illumina, IDEC Robin Steele, JD, LLM InterMune, Elan Corporation, Alveo, Alios Biopharma Jessica Grossman, M.D. Medicines360, Sense4Baby, Johnson & Johnson Sabrina Martucci Johnson, MSc, MIM Cypress Bioscience, WCG, Advanced Tissue Sciences, Baxter Healthcare
Portfolio Timeline Overview Timeline reflects management’s current estimates and constitutes a forward looking statement subject to qualifications elsewhere in the presentation. Actual development timeline may be substantially longer, and Daré is under no obligation to update or review this estimate. Ovaprene (Contraception) PCT Pivotal Regulatory Filing Potential Launch Topical 5%Sildenafil Citrate Cream^ (FSAD) Longer-Acting Injectable^ ORB- 204 ORB- 214 Vaginal Drug Delivery^ DARE-FRT1 DARE-OAB1 DARE-VVA1 Phase 3 DARE-HRT1^ (Hormone Replacement Therapy) Formerly JNP-0201 Phase 1 CDRH / Device Lead Hormone-free Contraception DARE-RH1 Pre-Clinical & Strategic Development Options Phase 2b Regulatory Filing ^505(b)(2). Two Phase 3 Trials 2019 2021 2022 2018 2020 2023
www.darebioscience.com NASDAQ: DARE Trading as DARE since July 19, 2017