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Galecto Reports Second Quarter 2025 Operating and Financial Results

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Galecto (NASDAQ: GLTO), a clinical-stage biotech company, reported Q2 2025 financial results and provided updates on its lead program. The company's primary focus is advancing GB3226, a dual ENL-YEATS and FLT3 inhibitor for AML treatment, with plans to submit an IND application to the FDA in Q1 2026.

Financial highlights include cash position of $10.2 million as of June 30, 2025, expected to fund operations into 2026. Q2 2025 saw a net loss of $3.4 million ($2.60 per share), improved from $5.3 million loss in Q2 2024. R&D expenses decreased to $1.5 million from $1.8 million, while G&A expenses reduced to $2.0 million from $2.8 million year-over-year.

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Positive

  • Preclinical data shows GB3226's significant efficacy improvements compared to current FLT3 and menin inhibitors
  • Net loss improved to $3.4 million from $5.3 million year-over-year
  • Operating expenses decreased with R&D down to $1.5M and G&A down to $2.0M

Negative

  • Company will require substantial additional capital for future operations
  • Limited cash runway extending only into 2026
  • Cash position of $10.2M indicates potential need for near-term financing

News Market Reaction

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On the day this news was published, GLTO declined NaN%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

BOSTON, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for oncology and liver diseases, announced its operating and financial results for the quarter ended June 30, 2025.

“We remain focused on advancing our lead program, GB3226, a dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of AML,” said Dr. Hans Schambye, CEO of Galecto. “Our goal is to submit an Investigational New Drug (IND) application to the FDA in Q1 2026, and we are actively advancing key IND-enabling activities across pharmacology, toxicology, and CMC to support a smooth transition into the clinic.”

Preclinical data to date support the therapeutic potential of GB3226 both as a monotherapy and in combination to address the menin-resistant population within AML. GB3326 has demonstrated significant improvements in efficacy compared to current FLT3 and menin inhibitors, showing activity across a broad spectrum of patient genotypes.

Second Quarter 2025 Financial Results

Cash and cash equivalents as of June 30, 2025, were approximately $10.2 million. The Company anticipates that its cash and cash equivalents will be sufficient to fund operating expenses and capital requirements into 2026, including the submission of an investigational new drug application for GB3226 to the FDA. However, the Company will require substantial additional capital to finance its operations, including future clinical development of its GB3226 and GB1211 programs.

Research and development expenses were $1.5 million for the three months ended June 30, 2025, compared to $1.8 million for the three months ended June 30, 2024. The decrease of $0.3 million was primarily related to decreased preclinical studies and clinical trial-related expenses of $0.1 million, decreased personnel costs of $0.6 million, and decreased consulting and other research and development costs of $0.3 million, offset by increased chemistry, manufacturing, and control costs of $0.7 million.

General and administrative expenses were $2.0 million for the three months ended June 30, 2025, compared to $2.8 million for the three months ended June 30, 2024. The decrease of $0.8 million was primarily related to decreased personnel costs of $0.3 million, decreased legal-related costs of $0.3 million, and decreased other general administrative costs of $0.2 million.

Net loss attributable to common stockholders for the quarter ended June 30, 2025, was $3.4 million or $(2.60) per basic and diluted share, compared with $5.3 million, or $(4.92) per basic and diluted share, for the prior year period.

About Galecto
Galecto is a clinical-stage biopharmaceutical company committed to realizing the promise of novel treatments for cancer and liver diseases. The Company’s pipeline consists of first-in-class small molecule drug candidates that target cancer and fibrosis signaling pathways, including (i) an orally active galectin-3 inhibitor (GB1211) for the treatment of liver cirrhosis; (ii) an orally active galectin-3 inhibitor (GB1211) in combination with a checkpoint inhibitor for various oncology indications; and (iii) a preclinical dual inhibitor of ENL-YEATS and FLT3 (GB3226) for multiple genetic subsets of AML. Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com.

Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about Galecto’s preclinical and clinical development plans for GB3226 and its potential to address challenging genetic subsets of AML and Galecto’s expectation that its cash and cash equivalents will be sufficient to fund its operating expenses and capital requirements into 2026, including the submission of an investigational new drug application for GB3226 to the FDA. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto’s product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, Galecto’s Annual Report on Form 10-K, as filed with the SEC on March 19, 2025, and Galecto’s Quarterly Report on Form 10-Q, as filed with the SEC on May 8, 2025. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

For more information, contact:

Investors/US
Sandya von der Weid
svonderweid@lifesciadvisors.com
+41 78 680 0538

 
GALECTO, INC.

Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
 
 June 30, December 31,
 2025 2024
 (unaudited)  
Cash and cash equivalents$10,211  $14,175 
Prepaid expenses and other current assets 2,816   2,664 
Operating lease right-of-use assets 75   73 
Other assets, noncurrent 589   220 
Total assets$13,691  $17,132 
    
Current liabilities$2,629  $1,197 
Operating lease liabilities, noncurrent 60   61 
Other liabilities, noncurrent 49   43 
Total liabilities 2,738   1,301 
Total stockholders’ equity 10,953   15,831 
Total liabilities and stockholders' equity$13,691  $17,132 


 
GALECTO, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
 
 For the Three
Months Ended
June 30,
 2025 2024
Operating expenses:   
Research and development$1,465  $1,834 
General and administrative 1,956   2,775 
Restructuring costs    968 
Total operating expenses 3,421   5,577 
Loss from operations (3,421)  (5,577)
Total other income (loss), net (12)  281 
Loss before income tax expense (3,433)  (5,296)
Income tax expense (4)  (42)
Net loss$(3,437) $(5,338)
Net loss per common share, basic and diluted$(2.60) $(4.92)
Weighted-average number of shares used in computing net loss per common share, basic and diluted 1,322,553   1,084,509 
Other comprehensive gain (loss), net of tax 509   (129)
Total comprehensive loss$(2,928) $(5,467)



FAQ

What is Galecto's (GLTO) cash position as of Q2 2025?

Galecto reported cash and cash equivalents of $10.2 million as of June 30, 2025, expected to fund operations into 2026.

What is the status of Galecto's GB3226 drug development program?

Galecto plans to submit an IND application to the FDA in Q1 2026 for GB3226, their dual ENL-YEATS and FLT3 inhibitor for AML treatment.

How did Galecto's Q2 2025 financial results compare to Q2 2024?

Galecto's net loss improved to $3.4 million ($2.60 per share) in Q2 2025 from $5.3 million ($4.92 per share) in Q2 2024, with reduced R&D and G&A expenses.

What are the main financial challenges facing Galecto (GLTO)?

Galecto will require substantial additional capital to finance operations and future clinical development of GB3226 and GB1211 programs beyond 2026.

What therapeutic advantages does Galecto's GB3226 show in preclinical studies?

GB3226 has demonstrated significant improvements in efficacy compared to current FLT3 and menin inhibitors, showing activity across a broad spectrum of AML patient genotypes.
Galecto Inc.

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