Galmed Pharmaceuticals Ltd. · NASDAQ:GLMD
Galmed Pharmaceuticals — Investor Presentation (June 2018)
25 slides from Galmed Pharmaceuticals's investor presentation, Jun 18, 2018
Slide 1: Galmed Pharmaceuticals | June 2018
‘ " « Pharmaceuticals GZ Galmed | June 2018
Slide 2: Safe Harbor and Disclaimer Statement
Safe Harbor and Disclaimer Statement This presentation contains forward - looking statements about our expectations, beliefs or intentions regarding, among other things, ou r product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from
Slide 3: Galmed Snapshot
Galmed Snapshot Galmed is advancing its lead compound, Aramchol™ towards registration with a focus on NASH, a market opportunity estimated to reach $ 35 - 40 B/ yr by 2025 * Experienced pharma leadership team We believe that data s upports c ontinued d evelopment of Aramchol™ 600mg to Phase 3 • Pre
Slide 4: Aramchol – NASH Disease Modification Potential
Aramchol ™ – NASH Disease Modification Potential Fast Track Designation for development of Aramchol ™ for NASH granted by FDA First - in - class, orally active, liver targeted SCD - 1 modulator Effects in animal models translated into human clinical data High safety margin and B/R ratio ~ 400 subjec
Slide 5: Leadership
Leadership Chaim Hurvitz CEO of CH Health; Previously, member of Teva’s senior management team and Board of directors. Carol L. Brosgart, M.D. Consultant to biotechnology companies in the areas of liver disease; Former director of Tobira Therapeutics. William S. Marth President & CEO of Albany Molec
Slide 6: Aramchol from Scientific Rationale to Clinical Results
Aramchol ™ from Scientific Rationale to Clinical Results SCD 1 Modulator - One Mechanism, Multiple Activities, Translated to Reduction in Liver Fat and Fibrosis
Slide 7: Effect of Aramchol on Oxidative Stress and Liver Injury
Oxidative Stress & Liver Injury Steatosis Glucose Serum FA FA FA Oxidation MUFA ER OxFA Mitochondria GSH/GSSG DG TG Lipid droplets CD36 DNL PX ROS Effect of ARAMCHOL PC ( 22 : 6 ) VLDL SCD - 1 IN MCD DIET MODEL 7
Slide 8: Aramchol - Antisteatogenic Effect - Translation from Animal Models to Human
Aramchol ™ - Antisteatogenic Effect - Translation from Animal Models to Human (phase 2 a and 2 b) ϴ Aramchol TM 5 mg/kg in mice and 300 mg in humans demonstrated statistically significant reduction of liver fat 1. Iruarrizaga-Lejarreta , Marta, et al. "Role of Aramchol in steatohepatitis and fibrosi
Slide 9: Aramchol – Antifibrogenic Translation from HSCs to Animal Models to Human Studies
Aramchol ™ – Antifibrogenic Translation from HSC’s (Collagen producing cells) to Animal Models to Human Studies 9 0 0.4 0.8 1.2 1.6 2 48h Relative Gene Expression SCD 1 in Hepatic Stellate Cells Vehicle Aramchol 10µM 0 2 4 6 8 10 12 48h Relative Gene Expression PPAR γ Vehicle Aramchol 10µM *** 0 0.5
Slide 10: Aramchol – Antifibrogenic Effect in TAA Animal Model
TAA + A ramchol™ 5 mg/kg TAA No Treatment Fibrosis Score (Masson & Goldner staining) Treatment Prevention 61.5 % 40 % R. Golan - Gerstl 1 , M. Valitsky 1 , R. Oren 1 , E. Brazovski 2 , L. Hayardeny 1 , S. Shimon Reif . "The anti - fibrotic effect of Aramchol on liver fibrosis in TAA animal model" (
Slide 11: ARREST Phase 2b: NASH resolution without worsening of fibrosis
In a one year, global Phase 2 b ARREST study, Galmed's Aramchol 600 mg achieved NASH resolution without worsening of fibrosis, one of two endpoints that may currently constitute a primary endpoint for a Phase 3 trial to support an FDA marketing application.
Slide 12: Aramchol Across Modalities
Aramchol ™ Across Modalities 12 -5 -4 -3 -2 -1 0 1 2 Placebo (N=41) Aramchol 400 (N=90) Aramchol 600 (N=83) Change from Baseline in Mean Liver Fat Liver fat - Mean Change from Baseline 24.4 % 36.7 % 47.0 % 0% 10% 20% 30% 40% 50% Placebo (N=41) Aramchol 400 (N=90) Aramchol 600 (N=83) MRI Responders -
Slide 13: Phase 2b Study: ARREST
Phase 2b Study: ARREST ARamachol ™ for REsolution of Steatohepatitis A Phase 2 b, double blind randomized, controlled clinical trial, to evaluate the efficacy and safety of two Aramchol TM doses versus placebo in patients with Non - Alcoholic Steatohepatitis (NCT 02279524 ) Design: Multicenter, glob
Slide 14: Subjects Disposition
Subjects Disposition 247 - No. of Subjects Randomized and included in ITT Placebo N= 48 Aramchol 400 N= 101 Aramchol 600 N= 98 41 (85.4%) Normal Termination 7 – Early Termination: • 3 - Withdrawal of Consent • 2 - Adverse Event • 0 - Lost to FU • 0 - Other Reason • 2 - Disallowed Medications 90 ( 89
Slide 15: Pre-defined Analysis Sets
Pre - defined Analysis Sets Randomized (ITT) (N= 247 ) Aramchol 400 (N= 101 ) Placebo (N= 48 ) FAS - MRI = 214 Aramchol 400 (N= 90 ) Aramchol 600 (N= 98 ) Aramchol 600 (N=83) Placebo (N = 41 ) FAS - biopsy = 198 Aramchol 400 (N= 80 ) Aramchol 600 (N= 78 ) Placebo (N =40) ITT= 247 • Statistical analy
Slide 16: Change from Baseline in Liver Fat (MRS)
Change from Baseline in Liver Fat (MRS) -5 -4 -3 -2 -1 0 1 2 Placebo (N=41) Aramchol 400 (N=90) Aramchol 600 (N=83) Change from Baseline in Mean Liver Fat Mean change from Baseline in Liver fat Aramchol 400 vs. Pbo p=0.0450 Aramchol 600 vs. Pbo p=0.0655 24.4 % 36.7 % 47.0 % 0% 5% 10% 15% 20% 25% 30%
Slide 17: NASH Resolution
NASH Resolution 5.0 % 7.5 % 16.7 % 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% Placebo (N=40) Aramchol 400 (N=80) Aramchol 600 (N=78) Proportion of patients Aramchol 400 vs. Pbo p= 0.4955 Aramchol 600 vs. Pbo p= 0.0514 Significantly more patients treated with Aramchol™ 600mg showed NASH resolution without wo
Slide 18: Fibrosis Improvement
Fibrosis Improvement 17.5 % 21.3 % 29.5 % 0% 5% 10% 15% 20% 25% 30% 35% Placebo (N=40) Aramchol 400 (N=80) Aramchol 600 (N=78) Proportion of patients Fibrosis Improvement (≥1 stage) Without Worsening of NASH Aramchol 400 vs. Pbo p= 0.8425 Aramchol 600 vs. Pbo p= 0.2110 More patients with fibrosis im
Slide 19: Change from Baseline in ALT
Change from Baseline to week 52 in ALT (U/L) -25.0 -20.0 -15.0 -10.0 -5.0 0.0 5.0 10.0 15.0 20.0 Change from Baseline Placebo Aramchol 400 Aramchol 600 Change from Baseline in ALT (U/L) Week 52 Week 40 Week 24 Week 52 Analyses Aramchol 400 vs. Pbo : p= 0.0002 Aramchol 600 vs. Pbo : p<. 0001 A statis
Slide 20: Change from Baseline in AST
Change from Baseline to week 52 in AST (U/L) A statistically significant reduction in AST with Aramchol™ 400 mg and 600 mg -15.0 -10.0 -5.0 0.0 5.0 10.0 15.0 Change from Baseline Placebo Aramchol 400 Aramchol 600 Change from Baseline in AST (U/L) Week 52 Week 40 Week 24 Week 52 Analyses Aramchol 400
Slide 21: Aramchol's safety and tolerability
Aramchol’s safety and tolerability • Good tolerability • Early terminations due to AEs occurred in 4.2 %, 3.0 % and 4.1 % in placebo, Aramchol 400 mg and 600 mg arms respectively • SAEs reported in 12.5 %, 8.9 % and 9.2 % of patients in placebo, Aramchol 400 mg and 600 mg arms respectively • No clus
Slide 22: Conclusions
Conclusions • ARREST was a placebo - controlled, one year global phase 2 b study in 247 biopsy - proven NASH patients with risk factors • Study results are compelling for Aramchol™ 600 mg demonstrating: • A significant effect on NASH resolution without worsening of fibrosis, one of two endpoints tha
Slide 23: Totality of data supports advancing Aramchol to a pivotal study
We presented here a set of data that speaks to the potential effect of Aramchol™ on multiple pathologies in NASH as measured by different modalities, MRS, biopsy and liver enzymes The totality of the data together with the good safety profile and tolerability gives us confidence in advancing Aramcho
Slide 24: Corporate Overview
Corporate Overview s* Financial Intellectual Property • 10 Patent Families • Areas of Focus: NASH, Combinations, Chemistry of Aramchol™, New Indications • Patent family (WO 2002 / 2083147 ) for use of Aramchol™ for the treatment of fatty liver granted worldwide. • 2 patent families ( 2017 ) for the
Slide 25: Thank You!
Thank You! NASDAQ: GLMD @ Galmed Phorm
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