Exhibit 99.1
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Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage Department of Neurosurgery, University Medical Center Mannheim, Ruprecht-Karls-University Heidelberg, Germany Director: Univ. Prof. Dr. Daniel Hänggi Hänggi D, Etminan N, Macdonald RL, Steiger HJ, Mayer SA, Aldrich F, Diringer MN, Hoh BJ, Mocco J, Strange P, Faleck HJ, Miller M for the NEWTON Investigators NEWTONNimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage
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Disclosure 2 PI worldwideScientific advisor / consultant: Edge Therapeutics
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Aneurysmal SAH Overview Aneurysmal subarachnoid hemorrhage Day 0 Day 7 3
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Nimodipine PLGA 70 µm microparticlesBiodegradable polymerSingle intraventricular injectionSustained-release formulation Nimodipine release for 21 daysTargeted delivery EG-1962 4
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Nimodipine PLGA 70 µm microparticlesBiodegradable polymerSingle intraventricular injectionSustained-release formulation Nimodipine release for 21 daysTargeted delivery EG-1962 EG-1962 5
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Phase 1/2 study: Safety, tolerability and pharmacokinetics of EG-1962 with enteral nimodipine Aneurysmal SAH Randomization Screening period EG-1962 Treatment period Follow-up period Day 0 Day 1 – 21 Day 30 Day 90 CT-scanSecondary Objective:Plasma CSF concentrations Standard of careEnteral nimodipineClipping or coiling GOSEmRSMoCABarthelNIHSSTICS NEWTON Study Design Trial registration: www.clinicaltrials.gov: NCT01893190 6 Hänggi D et al. Neurocrit Care, 2015 Identify maximum tolerated / feasible dose for pivotal phase 3 study (3:1 randomization EG-1962 or enteral nimodipine) Enteral nimodipine Clinical outcome at Day 90 (GOSE)Angiographic vasospasm, DCI, delayed cerebral infarctionUse of rescue therapyICU, hospital length of stay
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EG-1962 Cohorts 1 to 6 Enteral nimodipine 100 mg 200 mg 400 mg 600 mg 800 mg 1200 mg Total Demographic Variable (N=18) (N=9) (N=9) (N=9) (N=9) (N=9) (N=9) (N=54) Age Mean 56(+/-2) 64 (+/-3) 54(+/-3) 49(+/-5) 56(+/-4) 52(+/-4) 54(+/-3) 55(+/-8) Sex, n (%) Male 5 (28%) 1 (11%) 3 (33%) 5 (56%) 6 (67%) 7 (78%) 2 (22%) 24 (44%) Female 13 (72%) 8 (89%) 6 (67%) 4 (44%) 3 (33%) 2 (22%) 7 (78%) 30 (56%) NEWTON Demographics N = number of subjects randomized to treatment group and received treatment. 7
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NEWTON Safety Group Dose Deaths(unrelated) SAEs(related) Drug-related Hypotension DLTs EG-1962 100 mg 0 0 0 0 200 mg 2 0 0 0 400 mg 0 1 (Allergic Reaction) 0 1(ICP) 600 mg 0 0 0 0 800 mg 1 0 0 1 (ICP) 1200 mg 0 0 0 0 EG-1962 (n=54) All 3 (6%) 1 (2%) 0 (0%) Enteral nimodipine (n=18) 60 mg x 4 hours x 21 days 1 (6%) 0 (0%) 3 (17%) 8
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NEWTON Plasma nimodipine Concentration Note: Values are mean +/- …. 9
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56% Favorable Outcome(n = 5) 78% Favorable Outcome(n = 7) 67% Favorable Outcome(n = 6) 44% Favorable Outcome(n = 4) 56% Favorable Outcome(n = 5) Cohort 1 (100 mg; N = 9) enteral nimodipine(N = 18) Cohort 2(200 mg; N = 9) Cohort 3(400 mg; N = 9) 0% EG-1962 related hypotension Cohort 4(600 mg; N = 9) Cohort 5(800 mg; N = 9) NEWTON Clinical Outcome Dead Glasgow Outcome Scale (GOSE) – 90 Day Outcome Vegetative State Lower Severe Disability Upper Severe Disability Lower Moderate Disability Upper Moderate Disability Lower Good Recovery Upper Good Recovery 1 2 3 4 5 6 7 8 Unfavorable Outcome Favorable Outcome EG-1962 Active Control 17% (n = 3) related hypotension Favorable Outcome(n = 5) 28% 10
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56% Favorable Outcome(n = 5) 78% Favorable Outcome(n = 7) 67% Favorable Outcome(n = 6) 44% Favorable Outcome(n = 4) 56% Favorable Outcome(n = 5) enteral nimodipine(N = 18) 0% EG-1962 related hypotension NEWTON Clinical Outcome Dead Glasgow Outcome Scale (GOSE) – 90 Day Outcome Vegetative State Lower Severe Disability Upper Severe Disability Lower Moderate Disability Upper Moderate Disability Lower Good Recovery Upper Good Recovery 1 2 3 4 5 6 7 8 Unfavorable Outcome Favorable Outcome EG-1962 Active Control 17% (n = 3) related hypotension Cohorts 1-5(N = 45) Favorable Outcome(n = 5) 28% 60% Favorable Outcome(n = 27) 11
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EG-1962 Cohorts 1-5 (N = 45) NEWTON Exploratory Outcomes Vasospasm / DCI Cohort 1 (100 mg; N = 9) Enteral nimodipine(N = 18) Cohort 2(200 mg; N = 9) Cohort 3(400 mg; N = 9) Cohort 4(600 mg; N = 9) Cohort 5(800 mg; N = 9) (N = ) (5) (2) (4) (2) (2) (15) Delayed Cerebral Infarction (N = ) (1) (0) (0) (0) (2) (2) Rescue Therapy (N = ) (4) (1) (3) (1) (2) (10) (N = 15; 33% ) (N = 3; 7% ) (N = 11; 24% ) 12
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NEWTON Health Economics Reduced ICU Length of Stay (LoS)by 3.5 days Reduced Hospital LoS by 2.5 days Median ICU LoS Median Hospital LoS (n=45) (n=45) (n=18) (n=18) 13
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NEWTON Study All endpoints metMTD/MFD definedNo safety concerns Improved clinical outcomeLess rescue therapyReduced ICU and hospital length of stay 14
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NEWTON Study 15 Pivotal phase 3 study planned (US, Canada, Europe, Australasia)
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http://www.umm.uni-heidelberg.de/inst/nch/daniel.haenggi@medma.uni-heidelberg.de Department of Neurosurgery, University Medical Center Mannheim, Ruprecht-Karls-University Heidelberg, Germany Director: Univ. Prof. Dr. Daniel Hänggi Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage NEWTONNimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage