Galmed Pharmaceuticals Ltd. · NASDAQ:GLMD
Galmed Pharmaceuticals — Investor Presentation (August 2020)
24 slides from Galmed Pharmaceuticals's investor presentation, Aug 6, 2020
Slide 1: Amilo-5 MER, Specific, Targeted Immune-Modulator for Chronic Inflammatory Diseases
Amilo - 5 MER, Specific, Targeted Immune - Modulator for the Treatment of Chronic Inflammatory Diseases
Slide 2: Forward Looking Statements and Disclaimer
2 Forward Looking Statements and Disclaimer Statements 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.
Slide 3: Amilo-5 MER Highlights
3 Amilo - 5 MER Highlights Amilo - 5 MER is a Differentiated, Specific and Selective Immune - Modulator • Amilo - 5 MER is a penta - peptide that prevents Serum Amyloid A (SAA) polymerization and aggregation • Prevention of SAA polymerization and aggregation results in shut down of chronic inflammat
Slide 4: How Was Amilo-5 MER Discovered?
4 How Was Amilo - 5 MER Discovered? Isolation of joint inflammatory cells Identification of the MTADV (Methionine, Threonine, Alanine, Aspartic acid, & Valine) sequence in the human CD 44 variant Searching in the protein data bank reveals two proteins that contains the complete sequence MTADV Produc
Slide 5: Pentapeptide Specifically Sequenced to Interfere with SAA Aggregation
5 Amilo - 5 MER is a Pentapeptide Specifically Sequenced to Interfere with SAA Aggregation to Prevent Inflammation SAA - a validated biomarker and target for acute and chronic inflammatory disease • SAA has pro - inflammatory properties only in it’s aggregated forms • Aggregated SAA is a key player
Slide 6: SAA – an Inducer and Biomarker of Chronic Inflammation
6 SAA – an Inducer and Biomarker of Chronic Inflammation Increased expression IL - 1 / IL - 6 / TNF - a Infection/Inflammation C - terminal Cleavage b sheet Configuration Fibril Deposition Fibroblast Monocyte IL - 8 INF - a IL - 1 b IL - 18 INF - g TNF - a IL - 6 Monocyte - Derived Supernatant T - c
Slide 7: Interferes with SAA Aggregation to Inhibit Chronic Inflammation
7 Amilo - 5 MER Interferes with SAA Aggregation to Inhibit Chronic Inflammation Pro Inflammatory Cytokines – Inflammation & Tissue Destruction Infection / Stimuli Macrophage SAA Aggregates SAA Aggregates Amilo - 5 MER – Interferes with inflammatory vicious cycle by prevention of SAA aggregation
Slide 8: Prevents SAA Aggregation
8 Amilo - 5 MER Prevents SAA Aggregation WITHOUT Amilo - 5 MER WITH Amilo - 5 MER * Research work performed in collaboration with Prof. Mary Cowman from New York University Video recording of Nanoparticle tracking analysis of SAA* Number of SAA aggregates above a certain size counted in defined fram
Slide 9: An Opportunity in Acute and Chronic Inflammatory Conditions: IBD, RA and COVID-19
Amilo - 5 MER, an Opportunity in Acute and Chronic Inflammatory Conditions: IBD, RA and COVID - 19
Slide 10: Inflammatory Bowel Disease (IBD)
10 Inflammatory Bowel Disease (IBD) • IBD (ulcerative colitis and Crohn’s disease) is a chronic lifelong disease • IBD results from the interaction between genetic, microbial and environmental factors • The treatment goal in IBD is to induce and maintain remission Colon with Crohn’s Disease Normal C
Slide 11: Current IBD Therapies are Modestly Successful due to Undesired Side Effects
11 Current IBD Therapies are Modestly Successful due to Undesired Side Effects Unmet need in the treatment of patients with mild to moderate IBD • Treatment of IBD aims to control symptoms sustain remission and reduce complications • Low risk patient – Step Up approach - less potent drug with good s
Slide 12: IBD, Current and Future Therapy Directions
12 IBD, Current and Future Therapy Directions • Current IBD market consists of low - cost generics as well as expensive biologics • Anti - TNFs are essentially effective drugs however, several issues limit their long - term use limitation 1 : • Systemic Immune - Suppression with associated side effe
Slide 13: Significantly Affects Clinical Symptoms in IBD Animal Model (TNBS)
13 Amilo - 5 MER Significantly Affects Clinical Symptoms in IBD animal model ( TNBS) STUDY Description: • Evaluation of Amilo - 5 MER’s anti-inflammatory properties was demonstrated in the IBD’s Gold standard model of colitis induced by TNBS in C 57 bl 6 mice. • TNBS model is well-characterized, rel
Slide 14: Significantly Affects Clinical Symptoms in IBD Animal Model (TNBS)
14 Amilo - 5 MER Significantly Affects Clinical Symptoms in IBD animal model ( TNBS) Amilo - 5 MER ( 15 mg/kg) exerts stronger anti-inflammatory effects at the macroscopic and histological levels compared to anti-TNF antibody considered benchmark in the treatment of colitis. * : p< 0.05 ** : p< 0.00
Slide 15: Reduces Pro-Inflammatory Cytokines in Animal Model for IBD
15 Amilo - 5 MER Reduces Pro - Inflammatory Cytokines in Animal Model for IBD ( TNBS) Amilo - 5 MER ( 15 mg/kg) Significantly Decreases IL - 1 b and IL - 6 gene expression Evaluation of the Colonic mRNA levels in TNBS - induced Colitis in Mice * : P< 0.05 * : P< 0.05
Slide 16: IBD Market Potential
16 1 IBD Market Potential 4 M people afflicted 1.4 M in US 700,000 Crohn’s 70 % require surgery 700 K 100 K Global sales forecast ( by 2026 ) Crohn’s Disease Ulcerative colitis $ 13.8 B $ 6.8 B Physicians visits Hospitalizations 1 Global Drug Forecast and Market Analysis to 2026
Slide 17: Significantly Affects Clinical Symptoms in RA (Collagen Induced Arthritis Model)
17 CIA Sick C 57 BL/ 6 Mouse 9 Days after Amilo - 5 MER treatment Immunization with collagen ( 200 μ g/mouse) and CFA Boost: Collagen ( 200 μ g/mouse) and CFA 3 weeks Onset of disease 1 - 3 days 1 2 3 4 5 6 7 8 9 10 Peptide Injections: Days after disease onset Protocol: Assay under blind manner Coll
Slide 18: Restores the Normal Anatomy of the Inflamed Joint
18 Amilo - 5 MER Restores the Normal Anatomy of the Inflamed Joint Following Amilo - 5 MER treatment Control A representative stained histopathological joint section from a mouse with CIA following 9 days treatment with Amilo - 5 MER). Pathology (blinded) assessment indicate a joint of a normal mous
Slide 19: Reduces Pro-Inflammatory Cytokines ex-vivo in Human PBMCs
19 Amilo - 5 MER Reduces Pro - Inflammatory Cytokines ex - vivo in Human PBMCs Amilo - 5 MER inhibits SAA ability to stimulate secretion of pro - inflammatory cytokines from white blood cells (designated peripheral blood mononuclear cells, PBMCs) *** : P< 0.001 **** : P< 0.0001
Slide 20: Preclinical Safety Studies in Support of First-in-Human Study Completed
20 Preclinical Safety Studies in Support of First - in - Human Study Completed Maximum Tolerated Dose (MTD) studies in mice and dogs • 7 day MTD in mice at doses up to 1000 mg/kg, in dogs up to 200 mg/kg: No adverse effects were noted • 28 - days in mice at doses up to 175 mg/kg, an in dogs at doses
Slide 21: Phase 1b/2a IBD Study Design
21 Amilo - 5 MER: Phase 1 b/ 2 a IBD Study Design • Planned Study Design: Randomized, double blind, placebo - controlled • Population: 88 subjects aged 18 - 64 with Inflammatory Bowel Disease (IBD) • Dosing: QD (once daily) doses; 4 cohorts; placebo controlled • Treatment duration: 12 weeks • Primar
Slide 22: Significant Near Term Anticipated Milestones
22 Significant Near Term Anticipated Milestones 2020 2021 Q 3 Q 4 1 H 2 H Initiation of Phase 1 a in the UK Topline data from Phase 1 a Initiation of Phase 1 b/ 2 a IND submission Topline data from Phase 1 b
Slide 23: Summary
23 Summary • Chronic and inflammatory diseases are characterized by significant elevation of SAA which is a bio marker and inducer of this process • SAA induces inflammation only in its aggregated form • SAA aggregation and polymerization is a specific target to reduce inflammation • Prevention of S
Slide 24: Targeting Pathological SAA Aggregation to Prevent Chronic Inflammation
24 Targeting Pathological SAA aggregation to prevent: chronic inflammation, lymphocyte infiltration, pro - inflammatory cytokine secretion and tissue destruction Immunological Imbalance of the Intestinal Mucosa Auto Immune and Chronic Inflammatory Diseases Amyloid Plaques activation of the o
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