Form 8-K

8-K — GALECTIN THERAPEUTICS INC

Accession: 0001140361-26-021496

Filed: 2026-05-15

Period: 2026-05-15

CIK: 0001133416

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ef20073003_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20073003_ex99-1.htm)

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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 -

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20073003_ex99-1.htm · Sequence: 2

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.

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.

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.

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.

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.

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:

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).

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.

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.

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.

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.

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

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

)

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

Total stockholders’ deficit

(131,960

)

(127,918

)

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