Belapectin data and $30.8M 2025 loss at Galectin (NASDAQ: GALT)
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Galectin Therapeutics Inc. reported full-year 2025 results showing a narrower loss while advancing its belapectin program for MASH cirrhosis and portal hypertension. Net loss was $30.8 million for 2025, improved from $47.0 million in 2024, as total operating expenses fell to $20.1 million from $42.4 million on sharply lower research and development spending.
Basic and diluted net loss per share improved to $0.48 from $0.76, with 63.9 million shares used in the 2025 per-share calculation. Cash and cash equivalents were $17.7 million at December 31, 2025, up from $15.1 million a year earlier, and the company highlighted an additional $10 million line of credit from its chairman, extending projected cash runway through April 2027.
Management emphasized encouraging biomarker and clinical signals from the NAVIGATE study supporting belapectin’s potential antifibrotic and disease‑modifying activity in MASH cirrhosis and portal hypertension. Multiple NAVIGATE abstracts, including an oral presentation, were accepted for the EASL Congress, and the company expects an FDA meeting in the second quarter of 2026 to discuss next steps for belapectin.
Positive
- None.
Negative
- None.
Insights
Losses narrowed and cash runway extended as belapectin data mature.
Galectin Therapeutics reduced its 2025 net loss to $30.8M from $47.0M, largely by cutting research and development from $36.6M to $14.3M. Operating expenses roughly halved, which improved per‑share loss to $0.48 from $0.76.
Cash and cash equivalents rose modestly to $17.7M, and a new $10M credit line from the chairman is expected to fund operations into April 2027. However, total liabilities increased to $145.7M, and stockholders’ equity remained deeply negative at $(127.9M), underscoring financial risk.
On the clinical side, management described additional NAVIGATE biomarker and liver stiffness signals that support belapectin’s potential antifibrotic effect in MASH cirrhosis with portal hypertension. An FDA meeting planned for Q2 2026 will be important for clarifying the required development pathway, while multiple accepted EASL presentations highlight scientific interest in the dataset.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Net loss 2025: $30.8M
Total operating expenses 2025: $20.1M
R&D expense 2025: $14.3M
+5 more
8 metrics
Net loss 2025
$30.8M
Year ended December 31, 2025, vs $47.0M in 2024
Total operating expenses 2025
$20.1M
Down from $42.4M in 2024, mainly lower R&D
R&D expense 2025
$14.3M
Year ended December 31, 2025; $36.6M in 2024
Net loss per share 2025
$0.48
Basic and diluted, vs $0.76 in 2024
Cash and cash equivalents
$17.7M
Balance at December 31, 2025; $15.1M at December 31, 2024
Total liabilities
$145.7M
As of December 31, 2025; $120.6M at December 31, 2024
Stockholders’ equity (deficit)
$(127.9M)
As of December 31, 2025; $(104.8M) in 2024
Additional credit line
$10M
Line of credit from chairman extending projected cash runway through April 2027
Key Terms
MASH cirrhosis, portal hypertension, NAVIGATE dataset, galectin-3 inhibition, +2 more
6 terms
MASH cirrhosis medical
"the NAVIGATE dataset in patients with MASH cirrhosis and portal hypertension"
portal hypertension medical
"MASH cirrhosis and portal hypertension. We are encouraged by the signals observed"
An increase in blood pressure in the portal venous system — the veins that carry blood from the intestines to the liver — usually caused by scarring or blockage in the liver that acts like a traffic jam in a pipe. It matters to investors because it drives demand for treatments, diagnostics and procedures, influences clinical trial outcomes and regulatory decisions, and can materially affect healthcare costs and a company’s commercial prospects in liver-related therapies.
galectin-3 inhibition medical
"strengthen the biological rationale for galectin-3 inhibition and support continued evaluation"
Fast Track designation regulatory
"for which it has Fast Track designation by the U.S. Food and Drug Administration"
A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.
disease-modifying effect medical
"supporting belapectin’s potential antifibrotic activity and disease-modifying effect"
Earnings Snapshot
Net loss: $30.8M
Year ended December 31, 2025
Net loss
$30.8M
Total operating expenses
$20.1M
Net loss per share
$0.48
Cash and cash equivalents
$17.7M
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): March 31, 2026
(Exact name of registrant as specified in its
charter)
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive office) (zip code)
Registrant’s telephone number, including area code: (678 ) 620-3186
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuant to Section 12(b) of
the Act:
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Title of each class
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Trading Symbol
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Name of each exchange on which registered
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SECTION 2 – FINANCIAL INFORMATION
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Item 2.02
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Results of Operations and Financial Condition.
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On March 31, 2026, Galectin Therapeutics Inc. (“Galectin Therapeutics”) issued a press release
announcing its results of operations and financial condition as of and for the year ended December 31, 2025, and provided a business update. Galectin hereby incorporates by reference herein the information set forth in its press release dated March
31, 2026 (the “Press Release”), a copy of which is attached hereto as Exhibit 99.1.
Except for the historical information contained in this report, the statements made by Galectin Therapeutics are forward-looking statements that involve
risks and uncertainties. All such statements are subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. Galectin Therapeutics’ future financial performance could differ significantly from the expectations of
management and from results expressed or implied in the Press Release. Forward-looking statements in the Press Release are subject to certain risks and uncertainties described in the Press Release. For further information on other risk factors,
please refer to the “Risk Factors” contained in Galectin Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the Securities and Exchange Commission, and its subsequent filings with the SEC.
The information in this Item 2.02 is being furnished, not filed, pursuant to Item 2.02 of Form 8-K. Accordingly, the information in Item 2.02 of this
report, including the Press Release attached hereto as Exhibit 99.1, will not be incorporated by reference into any registration statement filed by Galectin under the Securities Act of 1933, as amended, unless specifically identified therein as being
incorporated therein by reference.
SECTION 9 – FINANCIAL STATEMENTS AND EXHIBITS
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Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits.
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Exhibit Number
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Description
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99.1
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Press Release dated March 31, 2026
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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.
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Galectin Therapeutics Inc.
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Date: March 31, 2026
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By:
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/s/ Jack W. Callicutt
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Jack W. Callicutt
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Chief Financial Officer
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Galectin Therapeutics Reports 2025 Financial Results and Provides Business Update
NORCROSS, Ga., March 31, 2026 (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, 2025.
Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said “We are at an important juncture for the belapectin development program. During 2025, we
made meaningful progress advancing the belapectin program and continuing our analysis of the NAVIGATE dataset in patients with MASH cirrhosis and portal hypertension. We are encouraged by the signals observed, including additional biomarkers from the
NAVIGATE dataset, and remain focused on evaluating the data as we engage with regulators, potential partners, and leading experts to determine the optimal path forward for the program.
Importantly, we also improved the Company’s financial position during the year, including securing an additional $10 million line of credit from our Chairman, Dick Uihlein,
to extend our projected cash runway through April 2027. Also, just very recently, we have strengthened our Board with the appointment of Dr. Henry Brem, an internationally recognized neurosurgeon-scientist
and leader in translational medicine, whose clinical development experience will be valuable as we advance the program. With no approved therapies currently available for patients with MASH cirrhosis, we believe belapectin has the potential
to address a significant unmet medical need and look forward to discussing the program with FDA.”
1
Khurram Jamil, M.D., Chief Medical Officer, added “The NAVIGATE dataset continues to provide encouraging insights supporting belapectin’s potential role in patients with MASH
cirrhosis and portal hypertension. In addition to the previously reported clinical finding of reduced varices incidence in the per-protocol population, additional biomarker analyses have demonstrated consistent signals across specialized markers of
fibrosis and noninvasive measures of liver stiffness, supporting belapectin’s potential antifibrotic activity and disease-modifying effect. These findings have been well received by the scientific community and were recently discussed by leading
hepatology experts during our March 10, 2026 virtual KOL event, where the data were reviewed in the context of disease progression and portal hypertension category risk in MASH cirrhosis. Taken together, these results further strengthen the biological
rationale for galectin-3 inhibition and support continued evaluation of belapectin as a potential therapy for patients with MASH cirrhosis, a population for whom there are currently no approved treatment options. We are excited about our upcoming FDA meeting in the second quarter of 2026 to align on the next steps for advancing the program. We are pleased to announce that multiple abstracts
from the NAVIGATE program have been accepted for presentations at the upcoming EASL Congress, including one oral presentation. This builds on our momentum from last year’s late-breaker presentation at EASL and oral presentation at AASLD 2025 and
reflects the continued interest from the scientific community in our unique and comprehensive dataset.”
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Belapectin Program Highlights
Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein involved in fibrosis and inflammation associated with MASH and portal hypertension.
MASH Cirrhosis
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NAVIGATE Phase 2b/3 trial (NCT04365868) is a
global, randomized, double-blind, placebo-controlled study evaluating belapectin administered intravenously at 2 mg/kg or 4 mg/kg of lean body mass (LBM) versus placebo every two weeks for 18 months for the prevention of esophageal varices in
patients with MASH cirrhosis.
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The NAVIGATE trial demonstrated:
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| o |
In the intent-to-treat population (n=355), the incidence of varices at 18 months was 43.2% lower in patients treated with belapectin 2 mg/kg compared with placebo, although the
composite endpoint did not reach statistical significance.
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In the per-protocol population (n=287), belapectin 2 mg/kg reduced the incidence of varices by 49.3% versus placebo (nominal p = 0.04).
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In U.S. patients within the per-protocol population (n=186), belapectin 2 mg/kg reduced the incidence of varices by 68.1% compared with placebo (p = 0.02).
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Safety results showed a similar proportion of treatment-emergent adverse events, serious adverse events, and discontinuations across treatment groups, with no drug-related serious
adverse events observed.
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3
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Additional 18-month NAVIGATE biomarker analyses presented in 2025 demonstrated consistent effects across multiple non-invasive markers of fibrosis and disease progression, including
FibroScan® liver stiffness measurement, ELF score, and PRO-C3, further supporting belapectin’s potential antifibrotic and disease-modifying activity in patients with compensated MASH cirrhosis and portal hypertension.
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Additional mechanistic analyses, including YKL-40 and PRO-C4, further supported belapectin’s biological activity, with findings consistent with reduced inflammation
and fibrogenesis.
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Analyses using validated Baveno VII criteria suggested belapectin treatment was associated with improvements in portal hypertension risk categories and a reduced risk
of hepatic decompensation compared with placebo.
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In March 2026, the Company hosted a virtual KOL event featuring leading hepatology experts who reviewed additional NAVIGATE biomarker findings and discussed their
implications for disease progression and portal hypertension risk in MASH cirrhosis.
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The Company will present new NAVIGATE trial analyses at EASL 2026 (May 27–30, 2026), including an oral presentation on reduced varices based on favorable changes in markers of
fibrosis formation and resolution (PRO-C3/CTX-III), and a poster presentation on risk reduction in clinically significant portal hypertension in advanced MASH cirrhosis.
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Full Year 2025 Financial Highlights
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As of December 31, 2025, the Company had $17.7 million of unrestricted cash and cash equivalents in addition to $10 million available under a line of credit provided
by our chairman to fund future operations. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through April 2027.
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4
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Research and development expenses for the year ended December 31, 2025 were $14.3 million compared with $36.6 million for the year ended December 31, 2024. The
decrease was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities.
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General and administrative expenses for the year ended December 31, 2025 were $5.8 million, compared to $5.9 million for the year ended December 31, 2024.
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For the year ended December 31, 2025, the Company reported a net loss applicable to common stockholders of $31.0 million, or ($0.48) per share, compared to a net loss
applicable to common stockholders of $47.2 million, or ($0.76) per share, for the year ended December 31, 2024. The decrease is largely due to a decrease in research and development costs due to the conclusion of the NAVIGATE trial.
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These results are included in the Company's Annual Report on Form 10-K, which has
been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.
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About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug belapectin is a
carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development
program is in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis, or NASH) with cirrhosis, the most advanced form of
MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical need and a significant drug development opportunity. Additional development programs are in treatment of combination immunotherapy for advanced head and neck cancers and other
malignancies. Advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to
achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release 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”, “look forward”, “believe”, “hope” and others. They are based on management’s 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 the hope that Galectin’s development program for belapectin will lead to the first therapy for the
treatment of MASH, formerly known as NASH, with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ
materially from those discussed in the forward-looking statements include, among others, full analysis of the NAVIGATE trial data may not produce positive data; Galectin may not be successful in developing effective treatments and/or obtaining the
requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company’s
current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and
marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be
unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully
develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December
31, 2025, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
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Company Contact:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
Investors Relations Contacts:
Kevin Gardner
kgardner@lifesciadvisors.com
Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin
Therapeutics’ galectin-3 inhibitor belapectin.
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Condensed Consolidated Statements of Operations
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Year Ended
December 31,
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2025
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2024
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Operating expenses:
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Research and development
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$
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14,290
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$
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36,571
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General and administrative
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5,795
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5,862
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Total operating expenses
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20,085
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42,433
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Total operating loss
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(20,085
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)
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(42,433
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)
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Other income (expense):
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Interest income
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126
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336
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Interest expense
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(7,329
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)
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(5,540
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)
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Change in fair value of derivatives
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(3,548
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)
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590
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Total other income
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(10,751
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)
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(4,614
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)
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Net loss
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$
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(30,836
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)
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$
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(47,047
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)
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Preferred stock dividends
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(138
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)
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(153
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)
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Warrant modification
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||||||||
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Net loss applicable to common stock
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$
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(30,974
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)
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$
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(47,200
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)
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Basic and diluted net loss per share
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$
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(0.48
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)
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$
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(0.76
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)
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||
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Shares used in computing basic and diluted net loss per share
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63,903
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62,309
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Condensed Consolidated Balance Sheet Data
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December 31, 2025
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December 31, 2024
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|||||||
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(in thousands)
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||||||||
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Cash and cash equivalents
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$
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17,720
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$
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15,120
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Total assets
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19,532
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17,495
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Total current liabilities
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8,030
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35,409
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Total liabilities
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145,727
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120,565
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Total redeemable, convertible preferred stock
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1,723
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1,723
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Total stockholders’ equity (deficit)
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$
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(127,918
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)
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$
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(104,793
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)
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# # #
8
FAQ
How did Galectin Therapeutics (GALT) perform financially in 2025?
Galectin Therapeutics reported a 2025 net loss of $30.8 million, an improvement from $47.0 million in 2024. Total operating expenses fell to $20.1 million, down from $42.4 million, mainly due to significantly lower research and development spending during the year.
What were Galectin Therapeutics’ 2025 R&D and G&A expenses?
In 2025, research and development expenses were $14.3 million, down from $36.6 million in 2024, while general and administrative expenses remained stable at $5.8 million versus $5.9 million in 2024. This sharp R&D reduction drove the substantial decline in total operating expenses.
What is Galectin Therapeutics’ cash position and runway after 2025?
At December 31, 2025, Galectin Therapeutics held $17.7 million in cash and cash equivalents, up from $15.1 million a year earlier. Management also highlighted a new $10 million credit line from the chairman, extending projected cash runway through April 2027.
How is Galectin Therapeutics advancing the belapectin program for MASH cirrhosis?
The company reported encouraging NAVIGATE data, including reduced varices incidence in a per‑protocol group and biomarker signals consistent with antifibrotic activity. Multiple NAVIGATE abstracts, including an oral presentation, were accepted for the EASL Congress, and an FDA meeting is planned in Q2 2026.
What are Galectin Therapeutics’ key balance sheet figures at year-end 2025?
At December 31, 2025, total assets were $19.5 million and total liabilities were $145.7 million. Stockholders’ equity was a deficit of $(127.9 million), compared with a $(104.8 million) deficit at the end of 2024, reflecting ongoing cumulative losses.
Filing Exhibits & Attachments
4 documents
Galectin Therapeutics Inc
NASDAQ:GALT
GALT Rankings
GALT Latest News
GALT Latest SEC Filings
Mar 31, 2026
[10-K] GALECTIN THERAPEUTICS INC Files Annual Report