Galecto Reports First Quarter 2025 Operating and Financial Results

Rhea-AI Summary

Galecto (NASDAQ: GLTO) reported its Q1 2025 financial results and provided updates on its drug development programs. The company continues to advance GB3226, its dual ENL-YEATS and FLT3 inhibitor for acute myeloid leukemia (AML), with IND submission planned for Q1 2026. Preclinical data shows improved efficacy compared to existing treatments.

Financial highlights include:

• Cash position of $11.9 million as of March 31, 2025
• R&D expenses decreased to $0.7 million from $2.5 million year-over-year
• G&A expenses reduced to $1.9 million from $3.3 million year-over-year
• Net loss of $2.5 million ($1.92 per share) compared to $5.5 million ($5.05 per share) in Q1 2024

Positive

• Net loss decreased significantly to $2.5 million from $5.5 million year-over-year
• Operating expenses reduced substantially with R&D costs down by $1.8 million and G&A costs down by $1.4 million
• Cash runway extends into 2026, covering planned IND submission for GB3226

Negative

• Low cash position of only $11.9 million
• Company will require substantial additional capital to finance operations and future clinical development
• Significant reduction in R&D spending might impact development progress

Insights

Biotechnology Analyst

Galecto's GB3226 progressing toward 2026 IND filing with promising preclinical data, but faces significant financing needs ahead.

Galecto continues to advance GB3226, their dual ENL-YEATS and FLT3 inhibitor targeting acute myeloid leukemia (AML). The company remains on schedule for an IND submission in Q1 2026, with preclinical work progressing as planned. The mechanism is particularly interesting as it combines two important targets in AML treatment - the preclinical data reportedly shows improved efficacy compared to existing FLT3 inhibitors and menin inhibitors across multiple genetic subtypes of AML.

This dual-targeting approach could potentially address limitations of current therapies. FLT3 inhibitors like gilteritinib have shown clinical benefit but face resistance mechanisms, while menin inhibitors are still establishing their role in treatment paradigms. If GB3226 can demonstrate superior efficacy across broader genetic subtypes as claimed, it could position the compound favorably in a competitive landscape.

The company's 72% reduction in R&D expenses ($0.7M vs $2.5M year-over-year) reflects their narrowed pipeline focus but raises questions about development pace. With IND-enabling studies being the primary focus, the reduced spending likely represents completion of earlier discovery work and streamlined operations targeting the regulatory submission.

For AML patients, new therapeutic approaches remain urgently needed, as five-year survival rates hover around 29% despite recent advances. GB3226's potential as both monotherapy and combination agent could be significant if preclinical promises translate to clinical outcomes, but the road to market remains long with the company not yet in clinical stages.

Financial Analyst

Significant cost cutting has extended Galecto's runway into 2026, but financing overhang remains with $11.9M cash and IND filing approaching.

Galecto's Q1 2025 financials reveal a company executing substantial cost-reduction measures to extend runway toward its Q1 2026 IND milestone. Cash position stands at $11.9 million, which management projects will fund operations "into 2026" - notably covering the planned IND submission but requiring "substantial additional capital" thereafter.

The company has dramatically reduced quarterly expenses, with R&D spending down 72% to $0.7 million and G&A expenses down 42% to $1.9 million year-over-year. These reductions primarily came from decreased personnel costs ($1.9 million combined reduction), suggesting significant workforce restructuring. The quarterly burn rate of approximately $2.5 million mathematically supports the runway projection into early 2026.

Net loss narrowed to $2.5 million ($1.92 per share) from $5.5 million ($5.05 per share) in Q1 2024, reflecting these operational efficiencies. However, the explicit acknowledgment of needing substantial additional funding creates a financing overhang that will likely impact valuation as the IND filing approaches.

The quarterly spend reveals a company in conservation mode, with minimal R&D expenditure for a development-stage biotech. While this extends runway, it creates a quiet period with limited catalysts before the Q1 2026 IND milestone. The lack of announced partnerships or non-dilutive funding sources suggests equity financing will likely be needed, with timing dependent on market conditions and progress with preclinical development of GB3226.

BOSTON, May 08, 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 March 31, 2025.

“During the first quarter, we continued to advance GB3226, our dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of AML,” said Dr. Hans Schambye, CEO of Galecto. “We continued preclinical studies to support our planned IND submission, which remains on track for Q1 2026. To date, preclinical data have shown significant improvement in efficacy compared to current FLT3 and menin inhibitors, with activity across a broad spectrum of patient genotypes. We believe GB3226 has the potential not only as a monotherapy but also as a powerful combination agent with existing standard of care and emerging therapies, offering new hope for patients with AML. We look forward to advancing GB3226 through IND-enabling studies and into clinical development in 2026.”

First Quarter 2025 Financial Results

Cash and cash equivalents as of March 31, 2025 were approximately $11.9 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 $0.7 million for the three months ended March 31, 2025, compared to $2.5 million for the three months ended March 31, 2024. The decrease of $1.8 million was primarily related to decreased preclinical studies and clinical trial-related expenses of $0.3 million, decreased personnel costs of $1.2 million and decreased consulting and other research and development costs of $0.3 million.

General and administrative expenses were $1.9 million for the quarter ended March 31, 2025, compared to $3.3 million for the quarter ended March 31, 2024. The decrease of $1.4 million was primarily related to decreased personnel costs of $0.7 million, decreased legal related costs of $0.5 million and decreased other general administrative costs of $0.2 million.

Net loss attributable to common stockholders for the quarter ended March 31, 2025, was $2.5 million or $(1.92) per basic and diluted share, compared with $5.5 million, or $(5.05) 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 (BRM-1420) 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; Galecto’s belief that GB3226 could be used as a monotherapy and in combination with other therapeutic agents, 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)
	March 31,				December 31,
		2025				2024
	(unaudited)
Cash and cash equivalents	$	11,939			$	14,175
Prepaid expenses and other current assets		2,984				2,664
Operating lease right-of-use assets		73				73
Other assets, noncurrent		369				220
Total assets	$	15,365			$	17,132
Current liabilities	$	1,551			$	1,197
Operating lease liabilities, noncurrent		60				61
Other liabilities, noncurrent		45				43
Total liabilities		1,656				1,301
Total stockholders’ equity		13,709				15,831
Total liabilities and stockholders' equity	$	15,365			$	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 March 31,
		2025				2024
Operating expenses:
Research and development	$	678			$	2,463
General and administrative		1,921				3,278
Total operating expenses		2,599				5,741
Loss from operations		(2,599	)			(5,741	)
Total other income, net		68				264
Loss before income tax expense		(2,531	)			(5,477	)
Income tax expense		(2	)			—
Net loss	$	(2,533	)		$	(5,477	)
Net loss per common share, basic and diluted	$	(1.92	)		$	(5.05	)
Weighted-average number of shares used in computing net loss per common share, basic and diluted		1,322,011				1,084,509
Other comprehensive gain (loss), net of tax		203				(54	)
Total comprehensive loss	$	(2,330	)		$	(5,531	)

FAQ

What is Galecto's (GLTO) cash position as of Q1 2025?

Galecto reported cash and cash equivalents of $11.9 million as of March 31, 2025, which is expected to fund operations into 2026.

How much did Galecto (GLTO) lose in Q1 2025?

Galecto reported a net loss of $2.5 million, or $1.92 per basic and diluted share, for Q1 2025.

What is GB3226 and when does Galecto plan to submit its IND?

GB3226 is Galecto's dual ENL-YEATS and FLT3 inhibitor for AML treatment. The company plans to submit an IND application to the FDA in Q1 2026.

How did Galecto's operating expenses change in Q1 2025 compared to Q1 2024?

R&D expenses decreased from $2.5M to $0.7M, and G&A expenses decreased from $3.3M to $1.9M compared to Q1 2024.

Will Galecto need additional funding for its operations?

Yes, the company stated it will require substantial additional capital to finance its operations, including future clinical development of GB3226 and GB1211 programs.