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Galectin Therapeutics (NASDAQ: GALT) trims Q1 2026 loss as R&D falls

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(Moderate)
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(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Galectin Therapeutics Inc. reported first-quarter 2026 results showing a smaller net loss while continuing to advance its belapectin program for MASH cirrhosis. For the three months ended March 31, 2026, net loss was $5.0 million compared with $9.6 million a year earlier, and basic and diluted net loss per share improved from $0.15 to $0.08.

Research and development expense declined to $2.2 million from $6.5 million, while general and administrative expense rose to $1.8 million from $1.4 million, leading to total operating expenses of $4.1 million versus $7.9 million. Cash and cash equivalents were $14.1 million as of March 31, 2026, down from $17.7 million at December 31, 2025, and stockholders’ deficit was $132.0 million.

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Insights

Galectin cut quarterly net loss mainly through lower R&D spending.

Galectin Therapeutics reported Q1 2026 net loss of $5.0M versus $9.6M a year earlier. The largest driver was research and development expense falling to $2.2M from $6.5M, while general and administrative costs increased modestly.

Total operating expenses declined to $4.1M from $7.9M, reducing the operating loss. However, cash and cash equivalents decreased from $17.7M at December 31, 2025 to $14.1M at March 31, 2026, and total liabilities remained high at $146.0M, alongside a stockholders’ deficit of $132.0M.

The company highlights continued work on its belapectin program in MASH cirrhosis, including further analysis of the NAVIGATE dataset and upcoming presentations at EASL later this month, plus a planned Type-C meeting with the FDA this quarter. Subsequent disclosures in company filings may provide more detail on how these clinical interactions influence future development plans.

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.
Net loss $5,046k Three months ended March 31, 2026 vs $9,631k in 2025
Basic and diluted net loss per share $0.08 Three months ended March 31, 2026; $0.15 in 2025
Research and development expense $2,231k Three months ended March 31, 2026; $6,485k in 2025
General and administrative expense $1,846k Three months ended March 31, 2026; $1,412k in 2025
Cash and cash equivalents $14,111k Balance at March 31, 2026; $17,720k at December 31, 2025
Total liabilities $145,996k As of March 31, 2026; $145,727k at December 31, 2025
Stockholders’ deficit $131,960k As of March 31, 2026; $127,918k at December 31, 2025
Shares used in EPS calculation 65,782k shares Basic and diluted, three months ended March 31, 2026
MASH cirrhosis medical
"NAVIGATE dataset in patients with MASH cirrhosis and portal hypertension."
galectin-3 medical
"Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of MASH and fibrosis."
Galectin-3 is a naturally occurring protein found in cells and blood that helps regulate inflammation, scarring (fibrosis), and cell growth; think of it as a cellular “smoke detector” that signals tissue stress or damage. Investors watch galectin-3 because it can serve as a biomarker for disease severity and prognosis—particularly in heart and fibrotic conditions—and because it is a potential target for diagnostics and new therapies, affecting market opportunity and clinical development risks.
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.
Type-C meeting regulatory
"our in-person Type-C meeting with FDA this quarter."
A type-c meeting is a routine regulatory discussion between a drug or medical device developer and a health authority to address issues not covered by more urgent or formal meeting types. It matters to investors because these meetings clarify development plans, data requirements and timelines—similar to a project check-in that can reveal whether a program is on track, likely to face delays, or needs more testing, all of which affect potential costs and future value.
NAVIGATE trial medical
"full analysis of the NAVIGATE trial data may not produce positive data;"
Net loss $5,046k
Basic and diluted net loss per share $0.08
Research and development expense $2,231k
Cash and cash equivalents $14,111k

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 
FORM 8-K
 

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported):  May 15, 2026



GALECTIN THERAPEUTICS INC.
 (Exact name of registrant as specified in its charter)



Nevada
001-31791
04-3562325
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(IRS Employer Identification No.)

4960 PEACHTREE INDUSTRIAL BOULEVARD, STE 240
NORCROSS, GA 30071
(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):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
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:

Title of each class
Trading
Symbol
Name of each exchange on which
registered
Common Stock $0.001par value per share
GALT
The Nasdaq Stock Market



SECTION 2 – FINANCIAL INFORMATION

Item 2.02
Results of Operations and Financial Condition.

On May 15, 2026, Galectin Therapeutics Inc. (“Galectin Therapeutics”) issued a press release announcing its results of operations and financial condition as of and for the three months ended March 31, 2026, and provided a business update. Galectin hereby incorporates by reference herein the information set forth in its press release dated May 15, 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

Item 9.01
Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number
Description
   
99.1
Press Release dated May 15, 2026
   
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)

- 2 -

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: May 15, 2026
By:
 /s/ Jack W. Callicutt
 

 
Jack W. Callicutt
 

 
Chief Financial Officer
 


- 3 -


Exhibit 99.1
 
 
Galectin Therapeutics Reports March 31, 2026 Financial Results and Provides Business Update
 
NORCROSS, Ga., May 15, 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 three months ended March 31, 2026.

“We continue to make meaningful progress advancing the belapectin program and further analyzing the NAVIGATE dataset in patients with MASH cirrhosis and portal hypertension. The additional analyses, including biomarker data, continue to support the potential of belapectin to impact disease progression in this high-risk population. We are looking forward to our upcoming data presentations at EASL later this month and our in-person Type-C meeting with FDA this quarter.  Additionally, we remain focused on engaging with potential partners and leading experts to help determine the optimal path forward.  This is an extremely exciting and consequential time in the Company’s history, and we will share updates as soon as possible.” said Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics.
 
Belapectin Program Highlights
Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of MASH and fibrosis.

1

MASH Cirrhosis


NAVIGATE Phase 2b/3 trial (NCT04365868) is a global, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of belapectin intravenously either belapectin 2 mg/kg of lean body mass (LBM) (n=119), 4 mg/kg/LBM (n=118) or placebo (n=118) every other week for 18 months for the prevention of esophageal varices in MASH cirrhosis.


Additional analyses from the NAVIGATE trial, including biomarker data, continue to support the potential of belapectin to impact disease progression in this high-risk population.

o
Statistically significant reductions in liver stiffness measurements (LSM), assessed by FibroScan®, were observed in the belapectin 2 mg/kg treatment arm at Weeks 26, 52 and 78, based on Mixed Model for Repeated Measures (MMRM) analyses of all clean and verified data collected throughout the study.

o
Treatment with belapectin was associated with a reduction in the proportion of patients experiencing clinically meaningful worsening in liver stiffness compared to placebo, including fewer patients with >30% increases from baseline (11.7% vs. 23.9%; p=0.03) and fewer patients with combined increases of >10 kPa and >30% over the 18-month treatment period.

o
These thresholds are clinically meaningful and associated with increased risk of liver-related complications, and the findings are consistent with a reduction in fibrosis progression, with placebo-treated patients continuing to demonstrate expected disease worsening over time.

2

Q1 2026 Corporate Highlights


Announced the appointment of Dr. Henry Brem to its Board of Directors in January 2026, further strengthening governance and strategic oversight.


Hosted a virtual key opinion leader (KOL) event in March 2026 focused on MASH cirrhosis and the clinical development of belapectin.

Upcoming Catalysts


Additional biomarker analyses from the NAVIGATE trial, including evaluation of belapectin’s impact on liver stiffness and fibrogenesis, will be presented in oral and poster presentations at the European Association for the Study of the Liver Congress in Barcelona, Spain:

o
Oral presentation by Mazen Noureddin: “Belapectin reduces varices development in high-risk MASH cirrhosis by modulating fibrogenesis balance as reflected by Pro-C3/CTX-III ratio” (Abstract REG26-611; Saturday, May 30, 2026, 10:15 AM–11:30 AM CET).

o
Poster presentation by Naim Alkhouri: “Risk reduction in clinically significant portal hypertension with belapectin in advanced MASH cirrhosis: results from the NAVIGATE trial” (Abstract REG26-612; Thursday, May 28, 2026, 8:30 AM–5:00 PM CET).


Upcoming FDA meeting to align on next steps for advancing the belapectin program and informing future clinical development plans in 2Q 2026.

3

Q1 2026 Financial Highlights


As of March 31, 2026, the Company had $14.1 million of cash and cash equivalents.  Additionally, the Company has $10 million remaining available under a line of credit provided by its chairman of the board to fund operations.  The Company believes it has sufficient cash to fund currently planned operations and research and development activities through May 2027.


Research and development expenses for the quarter ended March 31, 2026 were $2.2 million compared with $6.5 million for the same period in 2025. The decrease was primarily due to timing of incurrence of expenditures related to our NAVIGATE clinical trial.


General and administrative expenses for the quarter ended March 31, 2026 were $1.8 million, compared to $1.4 million for the quarter ended March 31, 2025.  The increase was primarily due to an increase in non-cash, stock-based compensation expense.


For the quarter ended quarter ended March 31, 2026, the Company reported a net loss applicable to common stockholders of $5.1 million, or ($0.08) per share, compared to a net loss applicable to common stockholders of $9.6 million, or ($0.15) per share for the quarter ended March 31, 2025.


These results are included in the Company's Quarterly Report on Form 10-Q as of and for the period ended March 31, 2026, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

4

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.

5

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.

Company Contact:

Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com

Investors Relations Contacts:
Kevin Gardner
kgardner@lifesciadvisors.com

6

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.

7

Condensed Consolidated Statements of Operations
 
   
Three Months Ended
March 31,
 
   
2026
   
2025
 
             
Operating expenses:
           
             
Research and development
 
$
2,231
   
$
6,485
 
General and administrative
   
1,846
     
1,412
 
Total operating expenses
   
4,077
     
7,897
 
Total operating loss
   
(4,077
)
   
(7,897
)
Other income (expense):
               
Interest income
   
36
     
35
 
Interest expense
   
(1,988
)
   
(1,744
)
Change in fair value of derivatives
   
983
     
(25
)
Total other income
   
(969
)
   
(1,734
)
                 
Net loss
 
$
(5,046
)
 
$
(9,631
)
Preferred stock dividends
   
(21
)
   
26
 
                 
Net loss applicable to common stock
 
$
(5,067
)
 
$
(9,605
)
Basic and diluted net loss per share
 
$
(0.08
)
 
$
(0.15
)
Shares used in computing basic and diluted net loss per share
   
65,782
     
63,204
 

Condensed Consolidated Balance Sheet Data
 
   
March 31, 2026
   
December 31, 2025
 
   
(in thousands)
 
Cash and cash equivalents
 
$
14,111
   
$
17,720
 
Total assets
   
15,759
     
19,532
 
Total current liabilities
   
7,307
     
8,030
 
Total liabilities
   
145,996
     
145,727
 
Total redeemable, convertible preferred stock
   
1,723
     
1,723
 
Total stockholders’ deficit
 
$
(131,960
)
 
$
(127,918
)

#   #   #


8

FAQ

How did Galectin Therapeutics (GALT) perform financially in Q1 2026?

Galectin Therapeutics reported a smaller net loss in Q1 2026. Net loss was $5.0 million versus $9.6 million in Q1 2025, and basic and diluted net loss per share improved from $0.15 to $0.08, mainly reflecting lower research and development spending.

What were Galectin Therapeutics’ key operating expenses in Q1 2026?

Operating expenses decreased substantially in Q1 2026. Research and development was $2.2 million compared with $6.5 million a year earlier, while general and administrative expense rose to $1.8 million from $1.4 million, bringing total operating expenses to $4.1 million.

What is Galectin Therapeutics’ cash position as of March 31, 2026?

As of March 31, 2026, Galectin Therapeutics held $14.1 million in cash and cash equivalents. This compares with $17.7 million at December 31, 2025, indicating the company used cash during the quarter while continuing development of its belapectin clinical programs.

What does the Q1 2026 balance sheet show for Galectin Therapeutics’ liabilities and equity?

At March 31, 2026, Galectin Therapeutics reported $146.0 million in total liabilities and a stockholders’ deficit of $132.0 million. Total assets were $15.8 million, and redeemable, convertible preferred stock was $1.7 million, reflecting a highly leveraged capital structure.

What updates did Galectin Therapeutics provide on the belapectin program?

The company reported continued progress in its belapectin program for MASH cirrhosis. Management is further analyzing the NAVIGATE dataset, preparing data presentations at EASL, and planning an in-person Type-C meeting with the FDA during the quarter to discuss the path forward.

Does Galectin Therapeutics have any regulatory designations for belapectin?

Yes. Belapectin, Galectin Therapeutics’ lead drug targeting galectin-3, has Fast Track designation from the U.S. Food and Drug Administration. The lead development program focuses on patients with metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis, an advanced form of liver fibrosis.

Filing Exhibits & Attachments

4 documents