Galmed Pharmaceuticals Ltd. · NASDAQ:GLMD
Galmed Pharmaceuticals — Investor Presentation (January 2018)
28 slides from Galmed Pharmaceuticals's investor presentation, Jan 3, 2018
Slide 1: Aramchol: Treating NASH through prevention and reversal of fibrosis
Aramchol ™ Treating NASH through prevention and reversal of fibrosis January 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 thing s, our product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, fr
Slide 3: Overview
Overview Scientific Rationale Clinical Data Corporate Overview
Slide 4: Galmed Snapshot
Galmed Snapshot Aramchol™ demonstrates anti - steatosis and anti - fibrotic effects consistently in all pre clinical models ( in - vitro and in - vivo ) 4 Galmed is advancing its lead compound, Aramchol™ towards registration with a focus on NASH SteatoFibrosis , a market opportunity estimated to rea
Slide 5: Aramchol – NASH Disease Modification Potential
Aramchol ™ – NASH Disease Modification Potential 5 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 subj
Slide 6: Seasoned Management Team
Seasoned Management Team Guy Nehemya , Adv., MBA, VP Operations Yael Hollander, Adv .,MBA , VP, Legal Affairs & Strategy Yohai Stenzler , CPA , MBA , CFO + 10 years of experience, Senior Clinical Program Leader at Teva Pharmaceuticals Dr. Tali Gorfine , M.D., CMO + 16 years of experience in drug dev
Slide 7: Scientific Rationale
Overview Scientific Rationale Clinical Data Corporate Overview
Slide 8: Pathways of NASH
8 Metabolism (Steatosis) Cell stress Apoptosis Collagen Production (Fibrosis) Inflammation Metabolism (Steatosis) Vitamin E CCR 2 - CCR 5 Galectin ARAMCHOL™ De - compensated Cirrhosis/ HCC Pathophysiology of NASH ASK 1 Caspase PPARs GLP - 1 FXR FGF 21 SCD 1 Aramchol™ Reduces Key Pathologies Pathways
Slide 9: Data Demonstrating Beneficial Effect of Aramchol on NASH
Hepatology 2003 ; 38:436 - 442 Archives of Biochemistry and Biophysics 471 ( 2008 ) 63 – 71 European Journal of Gastroenterology & Hepatology 2008 , 20:1205 – 1213 Archives of Medical Research 41 ( 2010 ) 397 - 404 9 Data Demonstrating Beneficial Effect of Aramchol™ on NASH
Slide 10: Data Support Improvement in Liver Steatosis & Inflammation
MCD 0.1 % Diet н Aramchol™ 5 mg/kg MCD 0.1% Diet MCD diet model is one of the most commonly used animal models of NASH, as it induces a liver pathology that resembles the sequence and progression of liver pathology seen in human. 10 52.6 % 86.4 % 79 % Iruarrizaga-Lejarreta , Marta, et al. "Role of A
Slide 11: Data Support Improvement in Liver Fibrosis
Collagen extract from livers of MCD diet mice treated with Aramchol Control MCD 0.1 % MCD 0.1 % +A ramchol™ 5 mg/kg Collagen Type 1 11 Iruarrizaga-Lejarreta , Marta, et al. "Role of Aramchol in steatohepatitis and fibrosis in mice. "Hepatology Communications 1.9 (2017): 911 - 927. 43.5 % 38 % Data S
Slide 12: Data Support Direct Effect on Prevention of Liver Fibrosis
12 TAA + A ramchol™ 5 mg/kg TAA No Treatment Fibrosis Score (Masson & Goldner staining) 40 % Data Support Direct Effect on Prevention of Liver Fibrosis Effect in the TAA model is considered to best predict efficacy in human R. Golan - Gerstl 1 , M. Valitsky 1 , R. Oren 1 , E. Brazovski 2 , L. Hayard
Slide 13: Aramchol Unique MoA on Collagen Producing Cells
MoA Suggesting Major Role of Aramchol™ in Fibrosis Cell number – Methylenblue (OD 620 nm) Relative Absorption COL 1 A 1 mRNA expression (a. u.) Stellate Cell Collagen Production – mRNA Stellate Cell Proliferation – Cell Number 58.9 % 41 % 13 Aramchol™ - Unique MoA to Show Effect on Collagen Producin
Slide 14: Role of ROS and glutathione in fibrogenesis
14 • The generation of ROS is well - known to play an important role in producing liver injury and initiating hepatic fibrogenesis . • ROS damages lipids, proteins and DNA, induces necrosis and apoptosis and amplifies the inflammatory response, all key factors in fibrogenesis . • Among the arsenal o
Slide 15: Clinical Data
Overview Scientific Rationale Clinical Data Corporate Overview
Slide 16: Phase IIa Study Design
A Phase 2 , Multicenter, Double - blind, Randomized, Placebo - Controlled Study on the Effect of Aramchol™ on Liver Triglycerides Concentration in Patients with Steatosis due to Non Alcoholic Fatty Liver Disease (NAFLD) or Non Alcoholic Steatohepatitis (NASH)* 1 6 Study Arms 300 mg; 100 mg; Placebo
Slide 17: Phase IIa Efficacy and Safety
Phase IIa Efficacy and Safety Overall and most frequent events ( > 2 patients in any group) Percent relative change in liver TG levels, baseline and end of treatment Aramchol 300 mg N = 20 n (%) Aramchol 100 mg N = 20 n (%) Placebo N = 20 n (%) Patients with AE(s) 9 (45.0) 8 (40.0) 11 (55.0) Preferr
Slide 18: ARREST Phase IIb Study
ARREST – AR amachol™ for RE solution of ST eatohepatitis A Phase IIb, 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 18 Design: Multicenter, randomized, double - blind, p
Slide 19: ARREST Baseline Histology
AR R EST Baseline Histolog y 70% of patients have NAS > 5 60 % of patients have fibrosis stage 2 and 3 3 % 36 % 20 % 40 % 1% 0 1 2 3 4 30 % 41% 19 % 8 % 2 % 4 5 6 7 8 NAS score NAS = NAFLD Activity Score, ranges from 0 - 8 and is composed of the unweighted sum of three histological components: st
Slide 20: What About Combinations?
What About Combinations? ✓ Aramchol ™ is an ideal candidate for combination treatment Fibrotic NASH is a complex disease resulting from the interplay of numerous, interconnected damage pathways. Combination therapies are justified by complimentary MoA’s: • metabolic • inflammatory • fibrotic 20 Aram
Slide 21: ARRIVE Study in HIV-associated NAFLD
Aramchol TM versus placebo in the treatment of HIV - associated nonalcoholic fatty liver disease and lipodystrophy : A randomized, double - blinded, allocation - concealed, placebo controlled clinical trial . An investigator - initiated study conducted at the NAFLD Research Center, University of Cal
Slide 22: Corporate Overview
Overview Scientific Rationale Clinical Data Corporate Overview
Slide 23: Corporate Overview: Financial, Ownership, Intellectual Property
Corporate Overview s Financial Ownership Structure ( 1 ) Intellectual Property • 16 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 US Prov
Slide 24: Estimation of 2025 NASH Drug-Treated Patient Population
Estimation of 2025 NASH D rug - T reated P atient P opulation (US+EU 5 ) Description/Assumptions Source Value Driver Adult pop . size of countries EU 5 & US ; Linear yearly pop . growth rates 2013 to 2035 ; Adult pop . ( 20 - 70 years) is only relevant age group Intl. Diabetes Federation + 0.14 %
Slide 25: Key Takeaways About Galmed
5 Key Takeaways About Galmed 25 Experienced leadership Data from Phase IIa ARRIVE Study and Phase IIb ARREST Study expected in Q 1 & Q 2 2018 , respectively The effect on steatosis has been demonstrated in humans in a Phase IIa study with a significant reduction in liver fat demonstrated by MRS Aram
Slide 26: Thank you!
Thank you! NASDAQ: GLMD @ Galmed
Slide 27: Aramchol Reduces Established Fibrosis in MCD Diet Animal Model
Aramchol™ Reduces Established EASL Fibrosis in MCD Diet Animal Model ne | AT Seas a
Slide 28: Anti Fibrotic Effect of Aramchol in TAA Animal Model
EASL The Anti Fibrotic Effect of Aramchol™ on Liver Fibrosis in TAA Animal Model RESULTS Saree SN pisowcoplc tration core Ot KNOWLEDGEMENTS
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