Galecto Reports Second Quarter 2025 Operating and Financial Results

Rhea-AI Summary

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.

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

Insights

Biotechnology Research Analyst

Galecto reports $10.2M cash position with runway into 2026, advancing AML drug GB3226 toward IND filing in Q1 2026.

Galecto's Q2 results reveal a critical cash position of $10.2 million, which the company estimates will fund operations into 2026. This timeline aligns precisely with their planned IND submission for lead candidate GB3226, but raises important sustainability questions beyond this milestone. The reduced quarterly net loss of $3.4 million (versus $5.3 million in Q2 2024) demonstrates improved capital efficiency, achieved through strategic reductions in both R&D ($1.5 million, down from $1.8 million) and G&A expenses ($2.0 million, down from $2.8 million).

The company's explicit acknowledgment that it will require "substantial additional capital" signals potential near-term financing activities that could impact shareholder value. Meanwhile, GB3226's preclinical profile as a dual ENL-YEATS and FLT3 inhibitor for AML represents a differentiated approach targeting menin-resistant populations. The company's strategic reallocation of resources - cutting personnel and clinical costs while increasing CMC investment by $0.7 million - indicates a disciplined focus on IND-enabling activities.

From an oncology development perspective, the decision to position GB3226 for both monotherapy and combination treatment across multiple genetic AML subtypes demonstrates a strategically sound approach to maximize the compound's clinical and commercial potential in a highly competitive landscape. However, the company's limited runway creates significant execution pressure to deliver compelling data that can attract either partnership interest or additional investment before cash depletion becomes critical.

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.