Galectin Therapeutics (GALT 0.27%), a clinical-stage biotech firm focused on liver fibrosis and cancer, reported its second quarter 2025 results on August 14, 2025. The most significant news was a lower-than-expected GAAP loss per share of $0.12 and reduced expenses as Galectin advanced its NAVIGATE trial for belapectin, an investigational therapy for MASH cirrhosis. GAAP net loss per share was ($0.12), outperforming analyst GAAP EPS estimates of ($0.16). This improvement stems largely from lower research and development spending following a key clinical milestone. There was no revenue. Overall, the company tightened costs following the main phase of its flagship trial, maintained enough liquidity for near-term activities, and updated investors on progress toward strategic and regulatory goals.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | ($0.12) | ($0.16) | ($0.20) | N/A |
| Revenue (GAAP) | $0.0 | $0.0 | $0.0 | 0% |
| Research and Development Expense | $3.3 million | $9.8 million | (66.3%) | |
| General and Administrative Expense | $1.4 million | $1.5 million | (6.7%) | |
| Cash and Cash Equivalents | $13.8 million | $15.1 million(Dec 31, 2024) | -8.6% |
Source: Analyst estimates for the quarter provided by FactSet.
Overview of the Business and Focus Areas
Galectin Therapeutics is a biotechnology company developing novel therapies that target galectins, which are proteins linked to immune and fibrotic diseases. Its main program is belapectin, an intravenous galectin-3 inhibitor drug candidate being tested as a potential treatment for patients with cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH), especially those at risk of esophageal varices, which are dangerous vein enlargements in the esophagus caused by advanced liver disease.
The business centers on advancing belapectin through clinical trials, protecting related intellectual property, and seeking partners to help develop and possibly commercialize its therapies. Success depends on clinical trial outcomes, regulatory processes, partnership formation, and securing capital. Current priorities include engagement with the United States Food and Drug Administration (FDA) for late-stage trial feedback, further analysis and presentation of trial biomarker data.
Quarterly Developments and Performance Drivers
Research and development expense declined to $3.3 million from $9.8 million a year ago, primarily due to the timing of expenditures related to the NAVIGATE clinical trial, which ended in the first quarter of 2025. Research and development expense (GAAP) declined to $3.3 million from $9.8 million compared to Q2 2024. As noted by management, the decrease reflects the timing of major spending on the NAVIGATE clinical trial, which ended its active enrollment in Q1 2025. General and administrative expenses (GAAP) were $1.4 million, down from $1.5 million for Q2 2024.
The company reported no revenue, which is typical for development-stage biotechnology firms that do not yet have approved products on the market. The net loss applicable to common shareholders (GAAP) improved from $12.4 million in Q2 2024 to $7.6 million. This better result led the company to beat bottom-line expectations, with a GAAP per-share loss of ($0.12) versus analyst forecasts of ($0.16).
Financial flexibility was supported by cash and equivalents of $13.8 million as of June 30, 2025. In July, the company added a $10 million line of credit from its chairman, an insider, reinforcing the ability to fund planned operations through at least June 2026. This arrangement underscores the ongoing funding support from internal stakeholders.
No material one-time events, asset sales, or new collaborative agreements were announced during the quarter. The company’s negative shareholders’ equity (GAAP) stands at ($118.9 million) as of June 30, 2025, up from ($104.8 million) at December 31, 2024, reflecting ongoing operational losses.
Belapectin: Clinical Progress and Industry Context
The main product candidate, belapectin, is an intravenously administered galectin-3 inhibitor drug intended to reduce fibrosis and prevent complications in patients with advanced liver disease due to MASH. During the quarter, management updated investors on results from the pivotal NAVIGATE Phase 2b/3 trial. The most recent data continues to show encouraging signals in key biomarkers, specifically liver stiffness, which is a recognized indicator of fibrosis progression and future liver complications.
Results presented at the European Association for the Study of the Liver (EASL) Congress in May 2025 showed that patients receiving the 2 mg dose of belapectin had fewer increases in liver stiffness compared to placebo. At 18 months, only 11.7% of patients in the 2 mg group had a substantial increase in liver stiffness, versus 23.9% for placebo, corresponding to a relative reduction of 49.3% in the per-protocol population (PPP) of the NAVIGATE trial, as presented in December 2024. This lower rate of liver stiffness progression observed in the 18-month analysis of the NAVIGATE trial was viewed as a positive clinical signal, though it is important to note that the primary composite efficacy endpoint of the NAVIGATE study was not statistically met in the top-line results presented in December 2024. Biomarker responses and the effect on esophageal varices, however, remain highlights for further regulatory discussion.
Galectin continues to position its intellectual property portfolio as a company asset, with belapectin benefiting from Fast Track status designated by the FDA. This designation is intended to speed development and review of drugs for serious conditions.
The company remains focused on engagement with the FDA to determine possible next steps for belapectin, either toward additional trials or a potential path to approval. Management indicated plans to present additional biomarker data later this year, hoping these results will support future regulatory conversations and attract potential strategic partners. To date, however, there has been no progress on partnership formation or expansion of late-stage development beyond belapectin’s main indication. The field for MASH and cirrhosis treatments remains highly competitive, with several companies—many using monoclonal antibody or protein-based therapies—seeking similar outcomes.
Looking Ahead: Guidance and Watch Factors
Management reiterated that cash and available credit facilities should support planned operations through June 2026, assuming current research activities and spending levels. There was no quarterly or annual financial guidance, nor any forecast for revenue or partnership milestones. Investors are advised to watch for additional clinical and biomarker updates as well as clarity on regulatory milestones, given that no firm timeline for a potential new drug application has been announced.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
