UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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SECTION 7 – REGULATION FD
| Item 7.01 | Regulation FD Disclosure. |
On September 29, 2020, Galectin Therapeutics Inc. (the “Company) posted to its website a presentation which is attached hereto as Exhibit 99.1.
The information in this report is being furnished pursuant to this Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933 or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this report.
SECTION 9 – FINANCIAL STATEMENTS AND EXHIBITS
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description | |
| 99.1 | Corporate Overview Presentation, September 2020 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, Galectin Therapeutics Inc. has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Galectin Therapeutics Inc. | ||||||
| Date: September 29, 2020 | By: | /s/ Jack W. Callicutt | ||||
| Jack W. Callicutt | ||||||
| Chief Financial Officer | ||||||
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Corporate Overview September 2020 NASDAQ: GALT www.galectintherapeutics.com Exhibit 99.1
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,” “estimate,” “could,” “expect” and others. They are based on our current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding potential therapeutic benefits of our drugs, expectations, plans and timelines related to our clinical trials, supporting activities, potential partnering opportunities and estimated spending for 2020 and beyond. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, our trials and supporting CMC information may be impacted by COVID-19. We may experience delays in our trials, which could include enrollment delays. Future phases or future clinical studies may not begin or produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of our drugs are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. Strategies and spending projections may change. We may be unsuccessful in developing partnerships with other companies or obtaining capital that would allow us to complete our clinical trials or further develop and/or fund any future studies or trials. To date, we have incurred operating losses since our inception, and our future success may be impacted by our ability to manage costs and finance our continuing operations. For a discussion of additional factors impacting our business, see our Annual Report on Form 10-K for the year ended December 31, 2019, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements. Forward-looking statements
Overview NASH cirrhosis and belapectin NASH-CX results NASH-RX trial Summary Contents
Introduction by Joel Lewis
Conducting an adaptively-designed Phase 2b/3 trial of belapectin, a potent galectin-3 inhibitor, for the prevention of esophageal varices NASH cirrhosis (NASH-RX) First patient enrolled June 2020, first patient randomized August 2020 NASH market opportunity estimated to reach $35 - $40 billion/year by 2025* Efficacy observed in animal models and Phase 2b trial (NASH-CX) NASH-CX trial in patients with compensated cirrhosis and portal hypertension demonstrated that belapectin prevented the development of new esophageal varices in a population with a high degree of clinical unmet need with no available therapies and few in development Results of NASH-CX trial published in Gastroenterology (Chalasani, et. al. 2020) Belapectin has a robust IP portfolio (77+ granted and 27 pending patents) Composition of matter for complex carbohydrates and/or methods of use in treatment of fibrosis and other indications Patent applications filed for small molecule gal-3 inhibitors Experienced leadership * Deutsche Bank “NASH – the next big global epidemic in 10 years?” July 14, 2014 Galectin Overview
Over 35 years of relevant experience Solvay Pharmaceuticals, CEO Harold H. Shlevin, Ph.D., Former CEO and President, Consultant and Board Member Over 28 years of relevant experience Reach Health, CFO, Vystar Corporation, CFO, Corautus Genetics, Deloitte Jack W. Callicutt, CFO Over 35 years of relevant experience: Koor Biotechnologies, Charm Sciences, Glycogenesis, HU Medical School (Jerusalem), and Harvard University Eli Zomer, PhD, Pharm Development Over 31 years experience in clinical development, medical affairs & regulatory processes. UCB Inc., Abbott Laboratories, Solvay Pharmaceuticals Adam Allgood, Pharm D., Clinical Development Rex Horton, VP Regulatory Over 29 years of experience; Director Regulatory Affairs at Solvay Pharmaceuticals and Chelsea Therapeutics; Georgia Institute of Technology Head of regulation, quality assurance and manufacturing Pol F. Boudes, M.D.; Chief Medical Officer Over 25 years of experience in clinical drug development in immunology, endocrine, metabolic, orphan, and liver-related diseases, and he has contributed to the approval of multiple drugs, both in the US and globally, across a variety of therapeutic indications. Previous position was CMO of CymaBay Therapeutics Over 22 years of executive management experience: Uline, Inc.; Century America LLC; Deloitte & Touche Served on the Board of Directors since December 2017 Joel Lewis, CEO and President Strong, experienced management team
Overview NASH cirrhosis and belapectin NASH-CX results NASH-RX trial Summary Contents
Galectin proteins’ ability to dimerize creates the opportunity for galectins to link glycoproteins and form a lattice structure on the cellular surface and to promote cell-cell and cell-matrix interactions Galectin-3 expression is up-regulated in established human fibrotic liver disease, and disruption of Galectin-3 can markedly reduce liver fibrosis (*) * Source: Henderson et al., PNAS, 2006. Central role of Gal-3 in multiple pathological processes Belapectin targets and disrupts the function of galectin-3, which plays a major role in the progression of fibrotic diseases
Fatty Liver NASH: Cell Death Inflammation Fibrosis 1 Garcia-Tsao, G., Friedman, S., Iredale, J., Prinzani, M. Hepatology. 2010;51:14451449 Compensated cirrhosis Decompensated cirrhosis Stage 1 Stage 2 Stage 3 and 4 No varices Varices develop Bleeding, ascites, encephalopathy Low one year mortality (1-3%) ~50% one year mortality ≥6 >10 >12 Portal pressure (mmHg) The majority of companies are focused on pre-cirrhotic NASH Few companies with Phase 2/3 trials in NASH cirrhosis There is currently no treatment for NASH cirrhosis, a progressive disease that may result in liver failure and increased mortality Unlike many companies in the NASH space, Galectin is focusing on the compensated cirrhotic patients
Overview NASH cirrhosis and belapectin NASH-CX results NASH-RX trial Summary Contents
4 Liver-related complications (varices/bleeding, ascites, hepatic encephalopathy, liver-related death, or transplant) Endpoints Baseline Week 54 Primary endpoint Portal pressure: HVPG2 ✔ ✔ Secondary endpoints Liver biopsy3 ✔ ✔ Endoscopy (varices) ✔ ✔ Complications4 ✔ ✔ 1 Subjects were enrolled across 36 sites in the US 2 HVPG = Hepatic Venous Pressure Gradient 3 Histologic staging & quantitative morphometry for collagen Major inclusion criteria NASH cirrhosis (biopsy) HVPG2 ≥ 6 mmHg No cirrhosis complications No or small varices (50:50) Every other week infusion x 26 Treatment #Patients Placebo 54 GR-MD-02 2 mg/kg/LBM 54 GR-MD-02 8 mg/kg/LBM 54 Dosing and administration LBM – Lean Body Mass NASH-CX was a randomized, double-blind, placebo-controlled phase 2b clinical trial that enrolled 162 NASH cirrhosis patients1 Phase 2b Trial design
Placebo belapectin 2 mg/kg.LBM belapectin 8 mg/kg.LBM 13 9 8 10 11 12 n=33 Baseline Week 54 n=31 Baseline n=25 Week 54 n=23 n=23 Baseline n=22 Week 54 HVPG (mmHg) Statistically significant effect of 2 mg/kg.LBM dose on change in HVPG at baseline Mean Change from Baseline to Week 541 0.8 mmHg -1.08 mmHg p = 0.01 0.15 mmHg ns 1 ITT with LOCF, ANCOVA with LSD Mean ± SEM The belapectin 2 mg/kg.LBM group showed a statistically significant reduction in HVPG from baseline to week 54 for patients without varices
Trial hit a clinically relevant endpoint related to patient outcomes 1 Chi Square Percent New Varices Formation Placebo belapectin 2 mg/kg.LBM 6/33 0/25 p = 0.02 20 15 10 5 0 18% 0% Significantly fewer new varices developed in treatment groups versus placebo, and no patients in the 2 mg/kg.LBM treatment group developed new varices
Portal hypertension (PH) is a critical, clinically important consequence of cirrhosis and responsible for the majority of associated complications Portal pressures of ≥10 mmHg (HVPG) are associated with increased risk of decompensation and mortality For patients with compensated cirrhosis and PH without varices, there are no specific therapies indicated for reducing PH and/or directly treating the underlying liver disease Beta-blockers may improve outcomes in patients with portal hypertension and varices, but likely do not prevent development of varices/disease progression in early stage cirrhosis patients Practice guidelines do not recommend beta-blockers for the prevention of esophageal varices Belapectin was safe and well tolerated in NASH-CX trial Dropout rate of 6% suggests the drug was well tolerated and patients were adherent Results of NASH-CX provide strong rationale for NASH-RX trial and selection of a primary endpoint of prevention of varices Sources: AASLD Practice Guidelines, Garcia-Tsao et al. HEPATOLOGY, VOL. 65, NO. 1, 2017; La Mura et al. World J Hepatol 2015 April 8; 7(4): 688-695 Baveno guidelines; Ripoll et al. GASTROENTEROLOGY 2007;133:481–488; Brunt, Semin Liver Dis., 2004; 24; UpToDate; Cordon, World J Gastrointest Endosc., 2012 312-322 Belapectin has demonstrated efficacy in a clinically meaningful endpoint where no current therapies exist
NASH-CX is the first clinical trial to show positive results in compensated NASH cirrhosis without esophageal varices Reduction of portal pressure in a relevant subgroup of patients Improvement in liver cell death, a key component of NASH Prevention of new esophageal varices Belapectin was safe and well-tolerated FDA indicated its support for progression to varices as a surrogate endpoint and progression to large varices (or to small varices with a weal) as a component of a composite clinical benefit endpoint The assessment of varices is part of Standard of Care and can easily be assessed with endoscopy 50% of cirrhotic NASH patients do not have varices when diagnosed Further awareness of NASH should increase the number of cirrhotic patients who will need varices prevention These results support advancement of the development program to Phase 3 Summary of NASH-CX trial
Overview NASH cirrhosis and belapectin NASH-CX results NASH-RX trial Summary Contents
NASH cirrhosis Patients with NASH cirrhosis have the greatest immediate medical need This population is not being addressed by most drug developers, who focus on the prevention of NASH cirrhosis using liver biopsies as an efficacy endpoint An innovative seamless, adaptive Phase 2b/3 clinical trial developed with leading NASH experts Progression to varices is a potential surrogate endpoint Progression to large varices is a component of a composite clinical endpoint NASH cirrhosis patients with portal hypertension are at risk of developing esophageal varices which may bleed and are then life-threatening Approximately 130 sites in 12 countries and 315 patients in Phase 2b portion of the trial before a planned interim analysis Adaptively Designed Phase 2b/3 NASH-RX Trial Overview
Belapectin Phase 2b/3 Adaptively Designed Trial Belapectin 4 mg/kg LBM N = 105 Belapectin 2 mg/kg LBM N = 105 N = 140 new patients switch to 4 mg/kg LBM Placebo N = 105 N = 70 new patients Sample size re-estimation Interim Analysis to Inform Phase 3 1° endpoint: development of new varices Final Analysis 1° endpoint: development of new varices 2° endpoints: Proportion of patients with large varices or red wales Varices requiring treatment Hepatic decompensation events All-cause mortality MELD ≥ 15 Liver transplant non-invasive biomarkers Key Eligibility Criteria: 1). Nash cirrhosis 2). No varices 3). CTP Scores <= 7 4). Portal hypertension, at least 2: Thrombocytopenia Spleen ≥ 15cm Collaterals by imaging
Key clinical study milestones: First patient enrolled June 2020, first patient randomized August 2020 Global study: overall ~500 patients, ~130+ sites, 12 countries in North America, Europe, Asia and Australia; First segment before Interim Analysis will be ~315 patients Recruitment period for phase 2b portion estimated: ~ 12 – 14 months Key inclusion criteria NASH cirrhosis (baseline or historical liver biopsy) Clinical sign of portal hypertension No esophageal varices (esophago-gastro endoscopy) Interim analysis phase 2b expected ~Q2 2023 Galectin Phase 2b/3 trial – NASH-RX summary
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 baseline MELD<12 Liver transplant Biomarkers Informs Phase 4 features – sizing, duration NASH-RX: End of Phase 2b or 3 Accelerated approval application
Overview NASH cirrhosis and belapectin NASH-CX results NASH-RX trial Summary Contents
NASH Cirrhosis is a major unmet medical need with a large potential market NASH-CX trial is first positive phase 2 clinical data in a subset of patients without esophageal varices Belapectin was safe and well-tolerated and improved portal pressure and reduced development of varices GALT is competitively well positioned in the industry Large, experienced global CRO conducting the NASH-RX trial Phase 3 study: First Patient enrolled June 2020; Interim Analysis Data analysis expected Q2 2023 Combination cancer immunotherapy (Providence Cancer Institute) Galectin-3 important in cancer immunity with encouraging early clinical results Large potential to improve results of cancer immunotherapy – trial continuing Belapectin is a novel galectin-3 inhibitor that targets macrophages (a key driver in cirrhosis) and may improve multiple fibrotic diseases Summary of drug development program
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