Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (July 2018)
40 slides from Galectin Therapeutics's investor presentation, July 2018
Slide 1: GR-MD-02: Phase III Galectin-3 Inhibitor
GR-MD-02: Phase III Galectin-3 Inhibitor July 2018 NASDAQ: GALT www.galectintherapeutics.com 2018 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance and use words such as “may,” “
Slide 3: Galectin is a development stage biotech company with an experienced team
Galectin is a development stage biotech company with an experienced team Harold H. Shlevin, Ph.D., CEO and President Jack W. Callicut, CFO • Over 34 years of relevant experience • Solvay Pharmaceuticals, CEO • Over 27 years of relevant experience • CIBA Vision Ophthalmics (n/k/a Novartis Vision), SV
Slide 4: Galectin Therapeutics is developing treatments where the galectin-3 protein is implicated in disease
Galectin Therapeutics is developing treatments where the galectin-3 protein is implicated in disease Key Highlights ▪ Clinically meaningful improvement shown in Phase 2 study in primary program, NASH cirrhosis without varices • First randomized clinical trial of any drug to demonstrate statistically
Slide 5: GR-MD-02 targets and disrupts the function of galectin-3
GR-MD-02 targets and disrupts the function of galectin-3, which plays a major role in diseases that involve scarring of organs ▪ GR-MD-02 is a complex carbohydrate drug that binds to galectin-3 proteins and disrupts their function ▪ Galectin-3 plays a major role in diseases that involve scarring of
Slide 6: Contents
Contents ▪ NASH Cirrhosis ▪ Cancer Immunotherapy Combination ▪ Psoriasis and Atopic Dermatitis ▪ Summary ▪ Appendix 6 2018 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com
Slide 7: There is currently no treatment for NASH cirrhosis
There is currently no treatment for NASH cirrhosis, a progressive disease that can lead to significant mortality Compensated Cirrhosis Decompensated Cirrhosis Stage 1 Stage 2 Stage 3 and 4 NASH: No Varices Varices Develop Bleeding, Ascites, Encephalopathy Cell Death Fatty Liver Inflammation Fibrosis
Slide 8: Patients with NASH cirrhosis without varices have a high degree of unmet need
Patients with NASH cirrhosis without varices are at high risk for severe complications and have a high degree of unmet need Compensated Cirrhosis Decompensated Cirrhosis Significance of Targeting NASH Cirrhosis Stage 1 Stage 2 Stage 3 and 4 without Varices:NASH: No Varices Varices Develop Bleeding,
Slide 9: GR-MD-02 targets the ~230,000 NASH patients with cirrhosis and without varices
GR-MD-02 targets the ~230,000 NASH patients with cirrhosis and without varices Addressable Patient Population (2018 estimates, US and EU5) 1 2 3 4 Diagnosed NASH patients Diagnosed NASH patients Adult NASH patients Diagnosed NASH patients Population w/ cirrhosis with cirrhosis w/o varices ~23M ~9M ~
Slide 10: NASH-CX phase 2b trial design
NASH-CX was a randomized, double-blind, placebo-controlled phase 2b clinical trial that enrolled 162 NASH cirrhosis patients1 Phase 2b Trial Design Major Inclusion Criteria Dosing and Administration ○ NASH cirrhosis (biopsy) ○ No cirrhosis complications Every other ○ HVPG2 ≥ 6 mmHg ○ No or small var
Slide 11: Statistically significant reduction in HVPG for patients without varices
The GR-MD-02 2 mg/kg group showed a statistically significant reduction in HVPG from baseline to week 54 for patients without varices Mean Change from 0.8 -1.08 0.15 Baseline to Week 541 p <0.01 ns 13 Statistically 12 HVPG (mmHg) significant effect of 2 mg/kg dose 11 on change in HVPG at 10 baseline
Slide 12: 43% of patients without varices in 2mg/kg group showed clinically relevant HVPG decrease
43% of patients without varices in the GR-MD-02 2mg/kg group showed a ≥2 mmHg and ≥20% decrease from baseline compared to 13% in the placebo group Percentage of Patients Who Had a Clinically Relevant Reduction in HVPG With: • ≥ 2 mmHg Decrease From Baseline AND • ≥ 20% Decrease From Baseline p = 0.0
Slide 13: Change in Hepatocyte Ballooning Score at Week 54
Patients in the 2 mg/kg treatment group showed statistically significant improvement of liver cell death on liver biopsy1 p = 0.03 p = 0.09 0.4 Ballooning Score at Week 54 Change in Hepatocyte In the total 0.2 population there was improvement in cell death, a n=54 n=54 critical feature of NASH 0.0 n
Slide 14: Significantly fewer new varices developed in treatment groups
Significantly fewer new varices developed in treatment groups versus placebo, and no patients in the 2 mg/kg treatment group developed new varices 20 p = 0.02 Percent New Varices Formation 15 Trial hit a clinically relevant endpoint 10 related to patient outcomes 5 6/33 0/25 0 Placebo GR-MD-02 2 mg/
Slide 15: GR-MD-02 demonstrated efficacy in two clinically meaningful endpoints
GR-MD-02 has demonstrated efficacy in two clinically meaningful endpoints, where no current therapies exist ▪ Portal hypertension (PH) is a critical, clinically important consequence of cirrhosis and responsible for the majority of associated complications • Portal pressures of ≥10 mmHg are associat
Slide 16: GR-MD-02 was safe and well-tolerated
GR-MD-02 was safe and well-tolerated ▪ No differences between treatment groups in the number of patients with treatment emergent adverse events (AEs), grade 3/4 AEs, serious adverse events (SAE), or grade 3/4 laboratory abnormalities ▪ All but 2 SAEs were unrelated to study drug; 2 patients in 8 mg/
Slide 17: Phase 3-ready development trajectory
Positive effects of GR-MD-02 shown in a subset of patients in the NASH-CX trial has allowed the company to reach its current Phase 3-ready development trajectory Trial Design After incorporating advice and Target Patient Population guidance from the FDA, Galectin • Patients with NASH cirrhosis witho
Slide 18: Summary of GR-MD-02 in NASH Cirrhosis
Summary of GR-MD-02 in NASH Cirrhosis ▪ NASH-CX is the first clinical trial to show positive results in compensated NASH cirrhosis without esophageal varices • Clinically meaningful effect in reducing portal pressure in a subgroup of patients • Improvement in liver cell death, a key component of NAS
Slide 19: Contents
Contents ▪ NASH Cirrhosis ▪ Cancer Immunotherapy Combination ▪ Psoriasis and Atopic Dermatitis ▪ Summary ▪ Appendix 19 2018 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com
Slide 20: GR-MD-02 novel mechanism of action in combination immunotherapy
GR-MD-02 is believed to provide a novel mechanism of action with potentially important advantages in combination immunotherapy Galectin-3 secreted by cancer cells into the tumor microenvironment reduces the ability of immune system to fight cancer Even with newly approved drugs, a substantial unmet
Slide 21: Gal-3 effect on cancer cells, macrophages, and T-cells
Gal-3 has an effect on cancer cells, macrophages, and T-cells in the tumor microenvironment Gal-3 is produced by both tumor cells and 1 2 macrophages and has multiple effects, including: 1▪ Promoting angiogenesis and metastasis of cancer cells 2▪ Promoting macrophage M2 polarization, increasing 3 ch
Slide 22: GR-MD-02 appears to augment anti-tumor activity of immunotherapies
The galectin-3 inhibitor GR-MD-02 appears to augment the anti-tumor activity of cancer immunotherapies ▪ As a result of the multipronged effect on the immune system, a galectin-3 inhibitor could have synergistic effects with other immunotherapies ▪ Pre-clinical studies have shown positive effects on
Slide 23: Phase 1B trial of GR-MD-02 plus pembrolizumab
Phase 1B trial was initiated of GR-MD-02 plus pembrolizumab (KEYTRUDA) in patients with metastatic melanoma and other cancers GR-MD-02 used in combination with a flat dose (200 mg) of pembrolizumab in the following patients: • Metastatic melanoma with progression after other treatment including pemb
Slide 24: Response rate of 62.5% in melanoma with GR-MD-02 plus pembrolizumab
Response rate of 62.5% in melanoma for patients on GR-MD-02 plus pembrolizumab compares favorably to 33% best response of pembro alone Waterfall plot of best objective clinical response post treatment (RECIST 1.1) * Historic BR for prembolizumab (Keytruda) in melanoma alone * Head and Neck CA 24 201
Slide 25: CT scan shows resolution of intramuscular melanoma deposit
CT scan shows resolution of a large, intramuscular melanoma deposit Baseline Day 85 25 2018 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com
Slide 26: Multiple PET scan detected melanoma deposits resolved
Multiple PET scan detected melanoma deposits resolved Baseline Day 169 Multiple tumors in legs All tumors resolved 26 2018 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com
Slide 27: Multiple PET scan detected melanoma deposits resolved
Multiple PET scan detected melanoma deposits resolved Baseline Day 169 All tumors resolved: Multiple tumors normal contrast seen throughout body in heart, kidneys and (red arrows) bladder 27 2018 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com
Slide 28: Potential additional indications beyond melanoma
Potential additional indications in which to approach oncology market, beyond melanoma 1▪ “Hot” Tumors: highly immunogenic T cell responsive tumors with medium/ high somatic mutation rate • GR-MD-02 could address needs of patients un-responsive or resistant to PD-1 treatment 2▪ “Warm” Tumors: tumors
Slide 29: GR-MD-02 in Combination Cancer Immunotherapy
GR-MD-02 in Combination Cancer Immunotherapy ▪ As a galectin-3 inhibitor, GR-MD-02 may represent a novel mechanism of action that is believed to be differentiated from the many other drugs being tested ▪ Potentially important advantages in combination immunotherapy • Enhancement of activity with mul
Slide 30: Contents
Contents ▪ NASH Cirrhosis ▪ Cancer Immunotherapy Combination ▪ Psoriasis and Atopic Dermatitis ▪ Summary ▪ Appendix 30 2018 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com
Slide 31: GR-MD-02 has shown activity in moderate-to-severe plaque psoriasis
GR-MD-02 has shown activity in moderate-to-severe plaque psoriasis Reduction in PASI over Time in Patients Treated ▪ GR-MD-02 inhibits galectin-3, a protein that with GR-MD-02 binds to galactose containing glycoproteins and modulates inflammatory responses and is linked to the expression of targets
Slide 32: Contents
Contents ▪ NASH Cirrhosis ▪ Cancer Immunotherapy Combination ▪ Psoriasis and Atopic Dermatitis ▪ Summary ▪ Appendix 32 2018 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com
Slide 33: Summary of Drug Development Program
Summary of Drug Development Program ▪ GR-MD-02 is a novel antigalectin-3 drug that may modulate the immune system and may improve multiple diseases ▪ NASH Cirrhosis is a major unmet medical need with a large potential market • Galectin-3 is important in development of NASH cirrhosis • NASH-CX trial
Slide 34: Additional Information
Additional Information Company Website: ▪ http://galectintherapeutics.com/ Recent Filings: ▪ 8K June 12, 2018: https://www.sec.gov/Archives/edgar/data/1133416/0001193125 18190059/d600642d8k.htm ▪ 10Q March 31, 2018: https://www.sec.gov/Archives/edgar/data/1133416/0001193125 18160824/d711808d10q.htm
Slide 35: Contents
Contents ▪ NASH Cirrhosis ▪ Cancer Immunotherapy Combination ▪ Psoriasis and Atopic Dermatitis ▪ Summary ▪ Appendix 35 2018 Galectin Therapeutics | NASDAQ: GALT For more information, see galectintherapeutics.com
Slide 36: Patient Populations: Total Group
NASH-CX Trial Patient Populations: Total Group N = 290 Patients Screened N = 128 Screening Failures N = 162 Patients Randomized N = 54 N = 54 N = 54 Placebo (PLB) 2 mg/kg GR-MD-02 (GR2) 8 mg/kg GR-MD-02 (GR8) N=3 N= 2 N=6 Discontinued Treatment Discontinued Treatment Discontinued Treatment AE (1) AE
Slide 37: Patient Populations Based on Esophageal Varices
NASH-CX Trial Patient Populations Based on Esophageal Varices Patients Screened: N = 290 Definitions: Screening Failures N = 128 ITT = Intention to Treat ITT/LOCF = ITT/Last Observation Carried Forward mITT= ITT with end of study HVPG Patients Randomized: N = 162 1 Discontinued before 1st dose PP =
Slide 38: Study Demographics & Baseline Assessments
NASH-CX Trial Study Demographics & Baseline Assessments Total Placebo GR2 GR8 (n=162) (n=54) (n=54) (n=54) Age, years; median (IQR) 59 (52, 65) 59 (53, 64) 60 (53, 65) 58 (51, 63) Female, n (%) 113 (70) 36 (67) 34 (63) 43 (79) Non-Hispanic White, n (%) 132 (81) 46 (85) 46 (85) 40 (74) BMI, kg/m2; me
Slide 39: Baseline HVPG (mmHg) in Patient Groups
NASH-CX Trial Baseline HVPG (mmHg) in Patient Groups GR2 Total Placebo GR8 Mean ± SD Mean ± SD (n) Mean ± SD (n) Mean ± SD (n) (n) Full Analysis Set 12.2 ± 4.2 (162) 11.6 ± 4.0 (54) 12.4 ± 4.3 (54) 12.7 ± 4.2 (54) CSPH Sub-group 14.3 ± 3.4 (108) 14 ± 3.1 (33) 14.2 ± 3.9 (37) 14.8 ± 3.1 (38) MPH Sub-
Slide 40: Pembrolizumab plus GR-MD-02 Patients: Cohorts 1 and 2
Pembro + GR- MD-02 IO Trial Pembrolizumab plus GR-MD-02 Patients: Cohorts 1 and 2 Cohort Diagnosis Gender Age Disease Sites Prior Treatments Response 1 Melanoma Male 76 Subcutaneous (SQ), lung Surgery/IL-2/RT/oncolytic virus/Yervoy PR 1 Melanoma Female 63 SQ, muscle, lymph node (LN) Interferon/Yervo
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