GALT

EX-99.1

2 ef20073003_ex99-1.htm

EXHIBIT 99.1

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 w

EX-99.1

2 ef20068722_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

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.”

2

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

•

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.

•

The NAVIGATE trial demonstrated:

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.

o

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).

o

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).

o

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.

3

o

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 suppor

falseGALECTIN THERAPEUTICS INC0001133416GANASDAQ00011334162025-11-142025-11-14

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):  November 14, 2025

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 $0.001 par value per share

GALT

The Nasdaq Stock Market

SECTION 2 – FINANCIAL INFORMATION

Item 2.02

Results of Operations and Financial Condition.

On November 14, 2025, Galectin Therapeutics Inc. (“Galectin Therapeutics”) issued a press release announcing its results of operations and financial condition as of and for the nine months ended September 30, 2025, and provided a business update. Galectin hereby incorporates by reference herein the information set forth in its press release dated November 14, 2025 (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, 2024, 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 November 14, 2025

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: November 14, 2025

By:

/s/ Jack W. Callicutt

Jack W. Callicutt

Chief Financial Officer

- 3 -