Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Shareholder Meeting (December 2019)
27 slides from Galectin Therapeutics's shareholder meeting presentation, Dec 4, 2019
Slide 1: Corporate Update – focused on NASH Cirrhosis
Corporate Update – focused on NASH Cirrhosis Annual Stockholders Meeting December 4, 2019 Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains 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,” “estimate,” “could,” “expect” and others
Slide 3: Outline of Today's Presentation
Outline of Today’s Presentation Belapectin (GR-MD-02) and NASH CIRRHOSIS Highlights of NASH-CX Phase 2 study The road to Adaptively-Designed (Phase 2b/Phase 3) NASH-RX trial start Regulatory input and recent FDA interactions Revised study design Benefits and risks Sites & study status Next steps Sum
Slide 4: Targeting NASH Cirrhosis – Cirrhosis Stage
Targeting NASH Cirrhosis – Cirrhosis Stage Progression to Cirrhosis (5%) Fatty Liver NASH: Cell Death Inflammation Fibrosis 80-100M 24-30M 3-5M Estimated US Prevalence 1.5-2.5M 1.5-2.5M Clinical Hemodynamic (HVPG, mmHg) Biological Compensated Compensated Decompensated No varices or complications Var
Slide 5: Critical Importance of Esophageal Varices in NASH Cirrhosis
Critical Importance of Esophageal Varices in NASH Cirrhosis Esophagus: No Varices Esophageal Varices Bleeding Esophageal Varices An important goal of treatment of patients with Stage 1, compensated cirrhosis without esophageal varices is to prevent progression to varices and complications “No varice
Slide 6: The NASH-CX Trial: Highlights of results
The NASH-CX TRIAL Highlights of results © 2019 Galectin Therapeutics | NASDAQ:GALT
Slide 7: Belapectin (GR-MD-02) Development Program: Summary
Belapectin (GR-MD-02) Development Program: Summary Gal-3 null mice are resistant to development of NASH 1 and liver fibrosis 1, 2 GR-MD-02 is a glycopolymer (polysaccharide), considered a Nonbiological Complex Drug (NBCD) that binds to galectin-3 protein, has strong global patent protection, and is
Slide 8: NASH-CX Clinical Trial Design
NASH-CX Clinical Trial Design1 Every other week infusion X 26 Placebo (54) GR-MD-02 2 mg/kg (54) GR-MD-02 8 mg/kg (54) NASH cirrhosis (biopsy) HVPG ≥ 6 mmHg No cirrhosis complications No or small varices HVPG2 Liver Biopsy3 FibroScan MBT4 Complications5 Endoscopy X X X X X X X X X X X X X X 1 All su
Slide 9: Patient Populations – NASH-CX
Patient Populations – NASH-CX Patients Screened: N = 290 Screening Failures N = 128 Baseline Esophageal Varices N = 80 (ITT/LOCF) No Baseline Esophageal Varices N = 81 (ITT/LOCF) 1 Discontinued before 1st dose 10 Discontinued during dosing without end of study HVPG CSPH N = 67 MPH N = 13 CSPH N = 41
Slide 10: NASH-CX: HVPG Primary Endpoint
n=54 NASH-CX: HVPG Primary Endpoint Total Patient Population Placebo GR-MD-02 2 mg/kg Mean ± SEM HVPG (mmHg) n=52 n=53 n=50 n=54 n=49 Mean Change From Baseline to Week 541 0.3 -0.37 -0.42 p=0.45 p=0.49 Baseline Week 54 Overall mean baseline HVPG=12.22 mmHg (No significant difference between groups a
Slide 11: NASH-CX Patients Without Varices at Baseline
n=33 NASH-CX Patients Without Varices at Baseline (50% of total population) Placebo GR-MD-02 2 mg/kg Mean ± SEM HVPG (mmHg) n=31 n=25 n=23 n=23 n=22 Mean Change From Baseline to Week 541 0.8 -1.08 0.15 p < 0.01 p = 0.36 Baseline Week 54 Overall mean baseline HVPG=10.6 mmHg (No significant difference
Slide 12: NASH-CX: Development of New Varices
NASH-CX: Development of New Varices © 2019 Galectin Therapeutics | NASDAQ:GALT Chi-Square analysis used for comparisons Among patients without varices at baseline, there were more new varices in the placebo group than in the GR2 group
Slide 13: NASH-CX: HVPG in Patients Without Varices and Mild Portal Hypertension
NASH-CX: HVPG in Patients Without Varices at Baseline and Mild Portal Hypertension Both the GR2 and GR8 treatment groups had a statistically significant effect on the percent change in HVPG in patients without varices and MPH © 2019 Galectin Therapeutics | NASDAQ:GALT
Slide 14: NASH-CX: HVPG in Patients Without Varices and CSPH
NASH-CX: HVPG in Patients Without Varices at Baseline and Clinically Significant Portal Hypertension (HVPG >10 mmHg) © 2019 Galectin Therapeutics | NASDAQ:GALT Like the MPH group shown earlier, in patients with CSPH, the GR2 group showed a statistically significant reduction in HVPG when compared to
Slide 15: NASH-CX: Major Conclusions
NASH-CX: Major Conclusions GR-MD-02 had a statistically significant and clinically meaningful effect in reducing HVPG in patients with NASH cirrhosis who did not have baseline esophageal varices (50% of total patient population) Important drug effect in the total study population on liver biopsy, wi
Slide 16: Adaptively-Designed Phase 2b/3 Trial of Belapectin in NASH Cirrhosis
Adaptively-Designed Phase 2b/3 Trial of Belapectin in NASH Cirrhosis The NASH-RX trial © 2019 Galectin Therapeutics | NASDAQ:GALT
Slide 17: The Road to Phase 3 is often a Long Path
The Road to Phase 3 is often a Long Path © 2019 Galectin Therapeutics | NASDAQ:GALT There is light at the end of the tunnel
Slide 18: Road to Phase 3: Sequence of Events and Highlights
Road to Phase 3: Sequence of Events and Highlights Feb 2019 - FDA Meeting Purpose: Discuss potential surrogate endpoint of progression to varices for Phase 3 trial Indicated supportive of “the potential use of progression to varices as a surrogate endpoint and progression to large varices (or to sma
Slide 19: © 2019 Galectin Therapeutics | NASDAQ:GALT
© 2019 Galectin Therapeutics | NASDAQ:GALT
Slide 20: NASH-RX Adaptive Trial Design
GR-MD-02 4 mg N=75 - 100 Interim Analysis (DMC): to inform Phase 3 1◦ endpoint: incidence of varices (by EGD) Pre-planned adaptations Select optimal dose based on Ph2b data Randomize additional patients Incorporation of results of the HI study Key eligibility criteria NASH cirrhosis Without varices
Slide 21: NASH-RX: Segment 1 Features
NASH-RX: Segment 1 - Features Inclusion/Eligibility Criteria NASH cirrhosis No varices CTP score < 7 (Class A) Clinical signals suggesting portal hypertension with at least 2 of: Thrombocytopenia Spleen size ≥ 15 mm Evidence of collaterals by imaging Double-blind Duration 12-18 months (to be refined
Slide 22: Key Feature of NASH-RX Design at End of Segment
Key Feature of NASH-RX Design at End of Segment 1 Interim Analysis (DMC) to inform Phase 3 Interim Analysis informs: Primary EP: Incidence of varices Confirms dose selection from NASH-CX results and dose adjustment Informs a single dose into Phase 3 Event rate allows ‘right-sizing’ of Phase 3 e.g.,
Slide 23: NASH-RX: End of Segment
NASH-RX: End of Segment 2 Accelerated approval application Accelerated approval Primary Endpoint Development of new varices Secondary Endpoints Proportion of patients with large varices or red wales Varices requiring treatment Decompensation events All-cause mortality MELD > 15 in patients with base
Slide 24: NASH-RX: Adaptively-Designed P3 Trial Features, Benefits and Risks
NASH-RX: Adaptively-Designed P3 trial Feature, Benefits and Risks Study features potentially improving likelihood of showing Drug effects Clarity and reaffirmation of NASH-CX efficacy & safety Appropriate selection of dose – e.g., single dose (2 or 4 mg/kg) for P3 or both Hepatic Impairment study re
Slide 25: NASH-RX: Current Study Status
NASH-RX: Current Study Status Sites qualified by Covance ~130 sites in 12 countries Revisiting sites passed over due to biopsy, EGD testing frequency and HVPG requirements of earlier study design Sites being kept informed of status of study start Work completed for NASH-specific site network and num
Slide 26: NASH-RX: Additional Considerations & Next Steps
NASH-RX: Additional Considerations & Next Steps There is a delay due to modifying the protocol and resubmitting to FDA Change in first patient first visit to late Q1, 2020 Sites have been informed to maintain their interests Costs being reassessed Elimination of HVPG subgroup and reduced frequency o
Slide 27: Thank You
Thank You © 2019 Galectin Therapeutics | NASDAQ:GALT
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