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Delivering innovation by daring to be
different December 10, 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 as needed; DAR 's ability TO OBTAIN AND MAINTAIN INTELLECTUAL PROPERTY PROTECTION FOR ITS PRODUCT CANDIDATES; DAR 'S ABILITY TO DEVELOP product candidates ON 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.
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
Dar 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 the majority of assets are well positioned to be first-in-category opportunity. Multiple milestones and value drivers expected over the next 12 -
24 months: Advancing our Phase 3 and two Phase 2 programs, and Initiating development activities on Phase 1 and preclinical programs.
Coordinating Presence in Women's
Health Linking innovation to commercialization 1. https://www.prnewswire.com/news-releases/womens-health-market-size-worth-513-billion-by-2025--cagr-39-grand-view-research-inc-651064753.html Global Women's Health Market Worth $51 Billion by 2025 -
CAGR: 3.9% 1 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.
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. ^505(b)(2). *Ovaprene Post Coital Test (PCT) is a pre-pivotal clinical study.. HRT Phase 1 study to be conducted in Australia by Dar subsidiary. Barrier IVR Ferrous gluconate Non-Hormonal, Monthly Contraception Ovaprene
(PCT)* Top line 2H 2019 Topical Cream Sildenafil Female Sexual Arousal Disorder Sildenafil Cream, 3.6%^ Top line 4Q 2020 IVR Natural Estradiol + Natural progesterone Hormone Replacement Therapy DARE-HRT1^ Topline 2H 2019 Formerly JNP-0201
Vaginal Insert SERM Vulvar and Vaginal Atrophy (HR+ Breast Cancer Population) DARE-VVA1^ IVR Natural progesterone Pregnancy Maintenance (PTB & ART) DARE-FRT1^ IVR Oxybutynin Over-Active Bladder DARE-OAB1^ Ca2+ Target Non-Hormonal Male &
Female Contraceptive Target DARE-RH1 Injectable Etonogestrel 6 & 12 Month Injectable Contraception ORB 204 & 214^ Vaginal Gel Clindamycin Bacterial Vaginosis DARE-BV1^ Phase 3 Initiation 2H 2019 Formerly JNP-0301 Formerly JNP-0101 Formerly
PT-101 Formerly CatSper Formerly MP-101 CDRH / Device Lead
DARE-BV1 (Formerly MP-101) Clindamycin
2% gel for Bacterial Vaginosis
BV is the most commonly reported
vaginal infection in women ages 15-44.1 BV is characterized by a shift in the vaginal flora from the dominant Lactobacillus to a polymicrobial flora.2 BV has been associated with serious health issues, including preterm births, pelvic inflammatory
disease, increased susceptibility to sexual transmitted infections (including HIV infection) and other chronic health problems.1,2 A number of potential microbial pathogens, singly and in combinations, have been implicated in the disease process.
The list of possible agents includes Gardnerella, Atopobium, Prevotella, Peptostreptococcus, Mobiluncus, Sneathia, Leptotrichia, Mycoplasma, and BV-associated bacterium 1 (BVAB1) to BVAB3.1 Bacterial Vaginosis (BV) Symptoms & Causes of BV Center
for Disease Control and Prevention (CDC). www.cdc.gov/std/bv/stats.htm Onderdonk, A. et al. "The Human Microbiome during Bacterial Vaginosis," Clinical Microbiology Reviews, April 2016 Volume 29 Number 2
BV is characterized by the presence of
three of the following four criteria: Vaginal pH of >4.5 Clue cells on saline wet mount Release of a fish amine odor, A characteristic thin, homogenous vaginal discharge. In 1991, Nugent et al. described a Gram stain scoring system of vaginal
smears to diagnose BV. 1,3 The Nugent score is calculated by assessing for the presence of large gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small gram-variable rods (G. vaginalis morphotypes; scored
as 0 to 4), and curved gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2) and can range from 0 to 10. A score of 7 to 10 is consistent with BV. 1,3 BV is not considered to be a sexually transmitted infection, but it is more common in
women who are sexually active. Bacterial Vaginosis (BV) Symptoms & Causes of BV Sha, Beverly E., et al. "Utility of Amsel Criteria, Nugent Score, and Quantitative PCR for Gardnerella vaginalis, Mycoplasma hominis, and Lactobacillus spp.
for Diagnosis of Bacterial Vaginosis in Human Immunodeficiency Virus-Infected Women." JOURNAL OF CLINICAL MICROBIOLOGY, Sept. 2005, p. 4607-4612 https://www.keepherawesome.com/bacterial-vaginosis Wilson, J. "Managing recurrent
bacterial vaginosis." Sexually Transmitted Infections. 2004; 80(1): 8-11.. 2
In the US, an estimated 21 million
women aged 14-49 years (approximately 29%) are infected with BV.1,2 BV leads to symptoms including abnormal vaginal discharge and odor that are unpleasant and disrupt and interfere with a woman's relationships and general quality of life.
According to IMS/IQVIA data, the 2016 U.S. annual sales figures for BV prescriptions were in excess of $150 million including utilization of oral and vaginal forms of Clindamycin and Metronidazole.3 Starpharma's VivaGel has a PDUFA date
scheduled for January 2019 (BV treatment and prevention).4 Lupin's 1x oral Solosec launched in May of 2018.5 Bacterial Vaginosis Market Opportunity https://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm; Sucher, Allana et al.,
"Bacterial Vaginosis: A Review," US Pharmacist 2018: 43(9):32-33 IMS/IQVIA data (2016). Data on file https://www.biopharmcatalyst.com/calendars/pdufa-calendar
DARE-BV1 met clinical cure endpoint
in a proof-of-principle investigator initiated clinical study for the treatment of BV. Novel proprietary hydrogel-based drug delivery technology has been developed for use in intravaginal and urology applications. Designed to improve efficacy
through unique features: in-situ gelation, sustained erosion and adhesion at the site of administration. DARE-BV1 utilizes a proprietary drug delivery platform to deliver 2% clindamycin intravaginally. Novel formulation is designed to improve
efficacy following single administration due to optimal dual release sustained-erosion of clindamycin. Primary efficacy endpoint met in a proof-of-principle investigator initiated study in 30 women: 88% of evaluable subjects met clinical cure
endpoint at Test-of-Cure visit. 505(b)(2) regulatory pathway enables concise clinical development plan: NDA filing with FDA planned following successful completion of a single, ~250 subject pivotal study. Patents covering the licensed technology
have been granted with terms through 2028 and additional patents pending would have terms through 2035. Bacterial Vaginosis DARE-BV1 (Formerly MP-101) Opportunity Highlights
Bacterial Vaginosis DARE-BV1 (Formerly
MP-101) Proof of Principle Study Design Eligibility: Female subjects 18 years or older with confirmed clinical diagnosis of BV Primary Endpoint: Clinical Cure at Test-of-Cure visit (defined as resolution of clinical findings from baseline visit);
Secondary Endpoints: Proportion of patients with therapeutic and bacteriologic cures,1,2 Safety: Patients were questioned about their comfort level and adverse reactions they experienced. Day 1 Baseline Visit Day 7 - 14 Test-of-Cure Visit Day 21 -
30 Continued Clinical Response Visit Proof of Principle Study Design (n = 30) Single dose administered Tests Performed: Physiological symptoms pH Saline "wet mount" 10% KOH "whiff test" Urine pregnancy (if needed) Patients
questioned regarding comfort level & re-examined Tests Performed: Physiological symptoms pH Saline "wet mount" 10% KOH "whiff test" Urine pregnancy (if needed) Patients questioned regarding experience & re-examined
Tests Performed: Physiological symptoms pH Saline "wet mount" 10% KOH "whiff test" Urine pregnancy (if needed) Study Objective: Study the Efficacy and Safety of DARE-BV1 in the Treatment of Bacterial Vaginosis Therapeutic
cure was a composite endpoint, which required both clinical cure (defined as clinical cure: resolution of all 4 Amsel criteria) and bacteriologic cure (Nugent score < 4). Bacteriologic cure required a Nugent score < 4. Amsel & Gram Stain
Criteria: https://www.cdc.gov/std/tg2015/bv.htm
Bacterial Vaginosis DARE-BV1
(Formerly MP-101) Proof-of-Principle Study Summary 30 subjects; 26 subjects were evaluable Test-of-Cure Visit (Day 7 - 14): 88% (n = 23) subjects achieved clinical cure 5 of 9 subjects had therapeutic cure and 6 of 9 had bacteriologic cures
Continued Clinical Response Visit (Day 21 - 30): 92% (n = 24) subjects showed continued clinical cure 6 of 9 subjects had therapeutic cure and 7 of 9 had bacteriologic cures * Based on data from 9 evaluable patients
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=551e43d5-f700-4d6e-8029-026f8a8932ff&type=display http://www.clindesse.com/pdf/PI.pdf Efficacy of MP-101 gel for the Treatment of Bacterial Vaginosis Product Clinical Cure Nugent
Cure Therapeutic Cure MP-101 88% 67%* 55%* Solosec 1 62% 49% 37% Clindesse 2 42% 64% 56% Metronidazole vaginal gel, 1.3% 3 37% 20% 17% http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205223s000lbl.pdf A single dose of DARE-BV1
demonstrated high clinical cure rate compared to other approved products DARE-BV1
Bacterial Vaginosis DARE-BV1
(Formerly MP-101) Opportunity Highlights DARE-BV1 offers an attractive value proposition based on an established clinical profile of clindamycin, 505(b)(2) regulatory pathway and an attractive commercial opportunity. 505(b)(2) Regulatory Pathway
Single Phase 3 clinical trial planned for FDA approval Established Clinical Profile Vaginal application of DARE-BV1 (clindamycin phosphate 2%) has been shown to be safe and well tolerated Proof-of-principal study of DARE-BV1: Showed an 88% clinical
cure rate in BV patients Favorable efficacy profile over currently approved treatments Attractive Market Opportunity U.S. prevalence estimated to be ~21 million among women ages 14-49 Approved prescription drugs have clinical cure rates of <70%
Opportunity for significant upside and market expansion
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):749 63 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
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