Belapectin for MASH Cirrhosis and Portal Hypertension 2 Company introduction Joel Lewis CEO & President June 2025 Today's Agenda | 01 | Moderator Michael Cozart, LifeSci Consulting | | --- | --- | | 02 | Galectin Company Introduction Joel Lewis (CEO & President) | | 03 | Belapectin as Galectin-3 Inhibitor for MASH cirrhosis & Portal Hypertension Khurram Jamil, M.D. (CMO) | | 04 | Unmet Need & Patient Landscape Naga Chalasani, M.D. | | 05 | Khurram | | | Clinical Results – NAVIGATE Trial design & Results Nai ...

Summary of Galectin Therapeutics (GALT) Update / Briefing Company Overview - **Company**: Galectin Therapeutics (GALT) - **Focus**: Development of belapectin as a treatment for NASH cirrhosis and portal hypertension, addressing a significant unmet medical need [2][4] Industry Context - **Condition**: NASH cirrhosis is a leading cause of liver transplantation in the US, with an estimated 5 million adults affected, including 3.3 million with portal hypertension [8][9] - **Market Opportunity**: Belapectin is positioned as a first-in-class therapy for NASH cirrhosis, with peak sales potential estimated at $18 billion [15] Clinical Trial Insights - **Clinical Trials**: Multiple Phase IIb trials conducted, including the NAVIGATE trial, which focused on patients with NASH cirrhosis and portal hypertension [5][19] - **Mechanism of Action**: Belapectin is a Galectin-3 inhibitor, which has shown anti-inflammatory and anti-fibrotic effects in preclinical studies [5][6] NAVIGATE Trial Findings - **Patient Population**: Included patients with compensated NASH cirrhosis and portal hypertension, with no baseline varices [20][21] - **Primary Endpoint**: Focused on the development of esophageal varices and other hepatic decompensation events [22][36] - **Results**: - Statistically significant reduction in new varices in the belapectin 2 mg/kg group (11.3% vs. 22.3% in placebo) [27] - Reduction in liver stiffness observed, indicating less disease progression [28][30] - Safety profile comparable to placebo, with no significant adverse events reported [31][37] Key Opinion Leaders' Perspectives - **Expert Opinions**: KOLs emphasized the urgent need for effective therapies in the NASH cirrhosis population, highlighting belapectin's potential to fill this gap [8][9][12] - **Market Feedback**: Positive responses from payers and physicians regarding the clinical and economic benefits of belapectin [14] Additional Insights - **Endoscopic Endpoint**: The NAVIGATE trial utilized centrally adjudicated endoscopy videos to track variceal development, enhancing the reliability of results [39][41] - **Comparison with Other Therapies**: Belapectin targets a more advanced patient population compared to other investigational therapies, which often select for less severe cases [62][63] Conclusion - **Future Outlook**: Belapectin shows promise in addressing the unmet needs of patients with advanced NASH cirrhosis and portal hypertension, with a favorable safety profile and significant market potential [36][60]

NORCROSS, Ga., June 10, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin-3 for patients with MASH cirrhosis and portal hypertension, today announced that it will host a virtual key opinion leader (KOL) event on Monday, June 16, 2025 at 12:00 PM ET. To register, click here. The event will focus on the unmet need and current treatment landscape for metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertens ...

NORCROSS, Ga., May 15, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three months ended March 31, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated "This quarter, we remained laser-focused on advancing additional analyses for belapectin. I was extremely encouraged by the feedback we received last week at the ...

Exhibit 99.1 Galectin Therapeutics Reports 2024 Financial Results and Provides Business Update NORCROSS, Ga., May 15, 2025 (GLOBE NEWSWIRE) – Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three months ended March 31, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated "This quarter, we remained laser-focused on advancing additional an ...

Clinical Trials and Efficacy - The company has completed randomizations totaling 357 patients in the NAVIGATE trial, a Phase 2b/3 clinical study evaluating the safety and efficacy of belapectin for preventing esophageal varices in NASH cirrhosis patients [97]. - In the intent-to-treat population (N=355), the incidence of varices was reduced by 43.2% in the belapectin 2 mg/kg dose group compared to placebo, although the composite endpoint did not reach statistical significance [98]. - In the per-protocol population (n=287), the incidence of varices was reduced by 49.3% in the belapectin 2 mg/kg dose group, with a p-value of less than 0.05 [98]. - In the U.S. cohort (n=186), the incidence of varices was significantly reduced by 68.1% in patients treated with belapectin 2 mg compared to placebo (4 out of 60 vs 13 out of 62) [98]. - The Phase 2b NASH-CX trial enrolled 162 patients with compensated cirrhosis and portal hypertension, evaluating belapectin's safety and efficacy [113]. - In the NASH-CX trial, the mean change in hepatic venous pressure gradient (HVPG) was -0.37 mm Hg for the 2 mg/kg LBM dose and -0.42 mm Hg for the 8 mg/kg LBM dose, compared to a 0.3 mm Hg change in placebo [114]. - In patients without esophageal varices at baseline, the 2 mg/kg LBM dose of belapectin showed a statistically significant reduction in HVPG of -1.08 mm Hg (p<0.01) [115]. - The NASH-CX trial demonstrated a 0% incidence of new varices in the 2 mg/kg LBM group compared to 18% in the placebo group, indicating a significant clinical benefit [117]. - The NAVIGATE trial reported a 43.2% reduction in the incidence of varices in the belapectin 2 mg/kg group compared to placebo, although the composite endpoint did not reach statistical significance [122]. - In the per-protocol population of the NAVIGATE trial, the incidence of varices was reduced by 49.3% in the belapectin 2 mg/kg group (p<0.05) [122]. - The NAVIGATE trial showed a significant reduction of 68.1% in the incidence of varices in U.S. patients treated with belapectin 2 mg/kg (p=0.02) [122]. Safety Profile - The safety profile of belapectin remains encouraging, with rates of adverse events and serious adverse events comparable to placebo, and no drug-related serious adverse events reported in the NAVIGATE trial [99]. - The safety profile of belapectin in the NAVIGATE trial was comparable to placebo, with no drug-related serious adverse events reported [123]. - The Hepatic Impairment Study indicated that belapectin exposure did not increase with the degree of hepatic insufficiency, supporting its safety profile [130]. Financials and Expenses - Research and development expenses for Q1 2025 were $8,054,000, a decrease of $1,569,000 or 19.5% compared to Q1 2024 [136]. - Clinical activities expenses decreased from $5,872,000 in Q1 2024 to $4,466,000 in Q1 2025, primarily due to the timing of expenditures related to the NAVIGATE clinical trial [137]. - General and administrative expenses decreased by $182,000 or 11.4%, from $1,594,000 in Q1 2024 to $1,412,000 in Q1 2025 [140]. - As of March 31, 2025, the company had $7.4 million in unrestricted cash and cash equivalents, with an additional $11 million available under two lines of credit [141]. - Net cash used in operations decreased by $4,415,000 to $7,689,000 for Q1 2025 compared to $12,105,000 for Q1 2024 [142]. - The company has raised a net total of $314.5 million from public and private offerings since its inception [141]. Product Development and Future Plans - The company has a lead product candidate, belapectin, which has shown promise in treating liver fibrosis, severe skin disease, and cancer, particularly focusing on NASH cirrhosis and head and neck cancer [107]. - The company is pursuing a development pathway for belapectin in immuno-oncology, having filed a new IND with the FDA for advanced or metastatic head and neck cancer in combination with a PD-1 inhibitor [104]. - The company plans to file a Phase 2 trial with the FDA for belapectin in combination with an immune checkpoint inhibitor targeting recurrent or metastatic head and neck cancer [134]. - The company continues to analyze data from approximately 55 patients who completed 36 months of treatment, which may attract interest from potential strategic partners [100]. - The company has established a joint venture subsidiary, Galectin Sciences LLC, to develop small molecules that inhibit galectin-3, potentially expanding the uses of galectin-3 inhibitors beyond belapectin [103]. Combination Therapies - The Phase 1b trial combining belapectin with pembrolizumab (KEYTRUDA) showed a 50% objective response rate in advanced melanoma and a 33% response rate in head and neck cancer patients [133]. - The combination of belapectin with pembrolizumab may reduce autoimmune side effects associated with pembrolizumab [133]. Challenges and Limitations - The company is unable to provide accurate estimates for the costs and timing of bringing a drug candidate to market due to numerous variables [138].

Data presentation included efficacy and biomarker analyses from the NAVIGATE trial (n=287). Belapectin 2 mg/kg demonstrated a statistically significant reduction in new varices at 18 months in the per-protocol population (p=0.04). Significantly fewer patients in the belapectin treatment arms experienced worsening of liver stiffness as measured by FibroScan®, reinforcing the potential beneficial effect of belapectin in halting the progression of MASH cirrhosis. NORCROSS, Ga., May 12, 2025 (GLOBE NEWSWIRE) -- ...

NORCROSS, Ga., April 15, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin-3 for patients with MASH cirrhosis and portal hypertension, today announced that it will attend the EASL 2025 meeting and deliver a scientific presentation in the late-breaking oral presentation session. The meeting will be held May 7-10, 2025, in Amsterdam, Netherlands. "We are excited that data from our NAVIGATE study, evaluating belapectin, a galectin-3 in ...

NORCROSS, Ga., March 31, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2024. Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. NASH Cirrhosis Full Year 2024 Financial Highlights As of December 31, 2024, the Company had $15.1 million of unrestricte ...

Financial Performance - Net cash used in operations increased by $8,802,000 to $41,767,000 for 2024, compared to $32,965,000 for 2023[188] - Net cash used in operations increased by $1,909,000 to $32,965,000 in 2023 compared to $31,056,000 in 2022, driven by increased research and development expenses[191] - Net cash provided by financing activities was $31,227,000 in 2024, a decrease from $40,033,000 in 2023, primarily due to changes in transactions[190] - In 2023, the company received $40,033,000 in financing, up from $10,000,000 in 2022, with $30,000,000 from a convertible line of credit and $10,000,000 from stock purchase warrants[192] Research and Development - Research and development expenses for 2024 were $36,571,000, a decrease of 13.8% compared to $32,130,000 in 2023[174] - Clinical program expenses increased to $29,079,000 in 2024 from $23,942,000 in 2023, primarily due to NAVIGATE clinical trial activities[175] - Research and development expenses are charged as incurred, with significant costs related to the NAVIGATE clinical trial and third-party contract research organizations[199] Cash Position and Financing - As of December 31, 2024, the company had $15.1 million in unrestricted cash and cash equivalents, plus $6 million available under a line of credit[187] - The company has raised a net total of $314.5 million from public and private offerings since its inception[187] - The company believes it has sufficient cash to fund operations through August 2025, but will require additional financing thereafter[187] Clinical Trials - The NAVIGATE trial is currently the only active clinical trial, with no plans or funding for additional trials at this time[173] - The company has engaged outside vendors for clinical trial services, which are typically cancellable on 30 days notice[195] Operating Expenses - General and administrative expenses decreased by 1.3% to $5,942,000 in 2024 from $5,862,000 in 2023[178] - Stock-based compensation is measured at grant date fair value and recognized over the service period, with estimates for potential forfeitures included[200] - The company entered into an operating lease for office space in Norcross, GA, with an average rate of approximately $4,250 per month, effective from March 1, 2022[193] Market Risks and Losses - The company has incurred significant operating losses since inception and cannot assure future revenue generation[171] - The company is not exposed to significant market risks as of December 31, 2024, and 2023[201] - The company has not created any off-balance sheet entities that could materially affect liquidity or capital resources[196]