Full Press Release Details
Delivering innovation by daring to be
different June 15, 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 DAR BIOSCIENCE, INC. ("DAR " OR THE "COMPANY"). THIS PRESENTATION INCLUDES CERTAIN
INFORMATION OBTAINED FROM TRADE AND STATISTICAL SERVICES, THIRD PARTY PUBLICATIONS, AND OTHER SOURCES. DAR 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 DAR '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; DAR 's ability to raise additional
capital if and as needed; DAR 's ability to maintain and protect its intellectual property; DAR 'S ABILITY TO DEVELOP product candidates AT THE COST AND IN THE TIMELINEs set forth HEREIN; and other risk factors described in
DAR '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 DAR
does not undertake any obligation to update any forward-looking statement to reflect new information, future developments or otherwise, except as required by law.
Mission & Vision To become the
coordinating presence in women's health by identifying and unlocking innovation that addresses unmet need. To develop and optimize a portfolio of novel therapies that improve health outcomes and promote a better quality of life for women.
Dar Highlights Daring to be
different A pure play biopharmaceutical company squarely 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. Multiple milestones and value drivers expected between mid-2018 and late-2019 from two Phase 2 programs, each positioned to be first in
Coordinating Innovation in
Women's Health Dar 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 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 Dar is under no obligation to
update or review this estimate. 2018 Ovaprene (Contraception) Strategic Development Options 2019 2020 2021 2022 PCT Pivotal Regulatory Filing Potential Launch 2023 CDRH / Device Lead Phase 2 Phase 3 Regulatory Filing Potential Launch Topical
Sildenafil (FSAD) 505 (b) (2) ORB- 204 & ORB- 214 IVR Technology Vaginal Tamoxifen VVA 505 (b) (2)
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
What's Driving Innovation in
Contraception 5. 2017 SEC Financial Filings 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 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
1. Lo Loestrin Fe contains a low-dose combination of two female hormones. https://www.loloestrin.com/loloestrin/about-lo-loestrin 2. Minastrin https://www.minastrin24.com/ 3. https://www.nuvaring.com/how-nuvaring-works/ 4.
U.S. Contraceptive Market IMS NSP
through Dec 2016; : IRI 2013 Ersek, J, Matern Child Health J (2011) 15:497-506 www.guttmacher.org, contraceptive fact sheet Large Market Opportunity >$6 billion in US Rx sales of contraceptive products (2016).1 40 million women of
reproductive age currently using a contraceptive method. 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. Over the Counter (OTC) channel options are not optimal. Largest SKUs in the OTC channel are condoms and Plan-B.
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
What Women Want from Birth Control
Women's Preferences: Effective Pregnancy Prevention Convenient Product Forms 67% of women report that the vaginal ring has most of the features deemed extremely important.1 Less Hormones 85% of women would prefer a monthly option with a lower
hormone dose than the pill.2 Non-Daily & Non-Coital Options 80% currently use a non-coital dependent method avoiding interruption at the time of intercourse.3 Lessard, L,Perspectives on Sexual and Reproductive Health, Volume 44, Number 3,9-2012
Hooper, DJ, Clin Drug Investig. 2010;30(11):749 63 Ersek, J, Matern Child Health J (2011) 15:497-506 A non-hormonal, non-daily 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 Vaginal Ring1
Monthly, Hormone Free - Contraception Silicone ring Fluid-permeable mesh barrier Spermiostatic Environment Achieved through a contraceptive-loaded silicone matrix releasing non-hormonal active: Ferrous gluconate Monthly intravaginal ring
1-Month ring convenience Rx (OB/GYN) - upon approval Patent Protection 12 issued patents worldwide (9 U.S.) IP coverage through August 2028 Potential extension to 2033 Ovaprene New Contraceptive Opportunity 1. Data on file
Ovaprene Human Proof of Concept
Study 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 successfully prevented sperm from reaching the cervical canal in a previous human
postcoital test 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 Regulatory Strategy Step 1
- 2018 / 2019 - Postcoital test (PCT) The study is enrolling 50 couples, with the woman to be evaluated over the course of five menstrual cycles, with a target of having 25 women complete a total of 21 visits. Each woman's cervical mucus
will be measured at several points during the study: Cycle 1 - Baseline measurement (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 *Dare has not had any communications with the FDA regarding the specific PMA requirements for Ovaprene. 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. 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 - 2020 / 2021 (Anticipated)* 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 Valuation Drivers
(Potential) J.L. Schwartz et al. / Contraception 78 (2008) 237-244. Schwartz JL, Weiner DH, Lai JJ, et al. Contraceptive efficacy, safety, fit, and acceptability of SILCS, a novel single-size diaphragm. 2014. 2020 - 2H2021 2018 -
2H2019 PCT Clinical Trial Ex: Caya trial duration(1) - 14 months start to finish, including recruitment Pivotal Clinical Trial Ex: Caya trial duration (2) - 18 months start to finish, including recruitment 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 Dar is under no obligation to update or
review this estimate. 2H 2019 2H 2021 Year
Ovaprene Summary What Women Want
from Birth Control 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):749 63 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 Oral 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 Easily inserted and removed without a
provider. Immediate return to fertility.
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 and/or maintain sufficient physical sexual arousal. 19 Female Sexual Dysfunction Market Landscape No
20 Female Sexual Arousal Disorder
(FSAD) FSAD is characterized primarily by an inability to attain or maintain sufficient physical sexual arousal that causes distress or interpersonal difficulty. Estimated 23-33% of women with low arousal 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 distressed and actively seeking treatment 2 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.
21 In a Phase 2a study, Topical
Sildenafil (SST-6007) formulation demonstrated an increase in blood flow to the vaginal tissue in both pre- and postmenopausal women with FSAD. Dar secured global rights to SST-6007 in February, 2018 for all women's health indications
related to female sexual dysfunction and female reproductive health. Anticipate commencing a Phase 2b clinical trial 2H2018. Topical Sildenafil for FSAD Dar Secured Global Rights to SST-6007 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 Dar is under no obligation to update or review this
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: (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 22 Pfizer Viagra
Studies Increased Blood Flow and Clinical Efficacy with Oral Sildenafil in Women 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.
Topical Sildenafil is 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 Sildenafil may offer a safe, effective and on demand' solution to difficulties with sexual arousal. SST Formulation
Technology Topical Sildenafil for FSAD Leveraging SST Proprietary Technology 23 1. Data on file