[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Galecto, Inc.'s unaudited condensed consolidated financial statements for Q2 2025, including balance sheets, statements of operations, and cash flows, reveal liquidity challenges and going concern doubt - Galecto, Inc. is a clinical-stage biotechnology company focused on developing small molecule inhibitors for cancer and severe liver diseases, undergoing a strategic shift in September 2023 to focus on **GB3226** and **GB1211** while discontinuing GB2064[31](index=31&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk) - The company's existing cash and cash equivalents of **$10.2 million** as of June 30, 2025, are **insufficient** to fund operations for the next twelve months, raising **substantial doubt** about its ability to continue as a **going concern**; management plans to raise additional capital[37](index=37&type=chunk)[41](index=41&type=chunk) Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change (2025 vs 2024) | | :-------------------------------- | :------------ | :---------------- | :-------------------- | | Cash and cash equivalents | $10,211 | $14,175 | $(3,964) | | Total current assets | $13,027 | $16,839 | $(3,812) | | Total assets | $13,691 | $17,132 | $(3,441) | | Total current liabilities | $2,629 | $1,197 | $1,432 | | Total liabilities | $2,738 | $1,301 | $1,437 | | Total stockholders' equity | $10,953 | $15,831 | $(4,878) | Condensed Consolidated Statements of Operations and Comprehensive Loss Highlights (in thousands) | Metric (Three Months Ended June 30) | 2025 | 2024 | Change (2025 vs 2024) | | :---------------------------------- | :-------- | :-------- | :-------------------- | | Research and development | $1,465 | $1,834 | $(369) (-20.1%) | | General and administrative | $1,956 | $2,775 | $(819) (-29.5%) | | Restructuring costs | $0 | $968 | $(968) (-100.0%) | | Total operating expenses | $3,421 | $5,577 | $(2,156) (-38.7%) | | Net loss | $(3,437) | $(5,338) | $1,901 (-35.6%) | | Net loss per common share (basic & diluted) | $(2.60) | $(4.92) | $2.32 | | Metric (Six Months Ended June 30) | 2025 | 2024 | Change (2025 vs 2024) | | :---------------------------------- | :-------- | :-------- | :-------------------- | | Research and development | $2,143 | $4,297 | $(2,154) (-50.1%) | | General and administrative | $3,877 | $6,053 | $(2,176) (-35.9%) | | Restructuring costs | $0 | $968 | $(968) (-100.0%) | | Total operating expenses | $6,020 | $11,318 | $(5,298) (-46.8%) | | Net loss | $(5,970) | $(10,815) | $4,845 (-44.8%) | | Net loss per common share (basic & diluted) | $(4.51) | $(9.97) | $5.46 | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric (Six Months Ended June 30) | 2025 | 2024 | Change (2025 vs 2024) | | :-------------------------------- | :-------- | :--------- | :-------------------- | | Net cash used in operating activities | $(4,676) | $(10,036) | $5,360 | | Net cash provided by investing activities | $0 | $11,650 | $(11,650) | | Net cash provided by financing activities | $0 | $0 | $0 | | Net increase (decrease) in cash and cash equivalents | $(4,676) | $1,614 | $(6,290) | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) [Notes to Unaudited Interim Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [1. DESCRIPTION OF BUSINESS, ORGANIZATION AND LIQUIDITY](index=11&type=section&id=1.%20DESCRIPTION%20OF%20BUSINESS,%20ORGANIZATION%20AND%20LIQUIDITY) [2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=13&type=section&id=2.%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) [3. PROPERTY AND EQUIPMENT, NET](index=14&type=section&id=3.%20PROPERTY%20AND%20EQUIPMENT,%20NET) [4. FAIR VALUE MEASUREMENTS](index=14&type=section&id=4.%20FAIR%20VALUE%20MEASUREMENTS) [5. PREPAID EXPENSES AND OTHER CURRENT ASSETS](index=15&type=section&id=5.%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) [6. LEASES](index=15&type=section&id=6.%20LEASES) [7. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES](index=16&type=section&id=7.%20ACCRUED%20EXPENSES%20AND%20OTHER%20CURRENT%20LIABILITIES) [8. COMMITMENTS AND CONTINGENCIES](index=16&type=section&id=8.%20COMMITMENTS%20AND%20CONTINGENCIES) [9. STOCKHOLDERS' EQUITY](index=16&type=section&id=9.%20STOCKHOLDERS'%20EQUITY) [10. INCOME TAXES](index=19&type=section&id=10.%20INCOME%20TAXES) [11. NET LOSS PER SHARE](index=19&type=section&id=11.%20NET%20LOSS%20PER%20SHARE) [12. SEGMENT REPORTING](index=19&type=section&id=12.%20SEGMENT%20REPORTING) [13. SUBSEQUENT EVENTS](index=20&type=section&id=13.%20SUBSEQUENT%20EVENTS) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Galecto's financial condition and operations, noting strategic shifts, ongoing losses, and capital needs - Galecto is a clinical-stage biotechnology company focused on developing novel small molecule therapeutics for cancer and liver diseases, with a strategic focus on **GB3226** and **GB1211** following a corporate restructuring in September 2023[79](index=79&type=chunk)[80](index=80&type=chunk) - Existing cash and cash equivalents are projected to fund preclinical development of **GB3226** into **2026**, including IND submission, but **substantial additional capital** is required for clinical development of **GB3226** and **GB1211**[81](index=81&type=chunk)[96](index=96&type=chunk) - **GB3226**, a dual ENL-YEATS and FLT3 inhibitor, is in preclinical development for **acute myeloid leukemia (AML)**, with an IND submission planned for **Q1 2026** and initial Phase 1a clinical data expected in **2027**[82](index=82&type=chunk)[83](index=83&type=chunk)[88](index=88&type=chunk) - **GB1211**, a selective oral galectin-3 inhibitor, is being evaluated in an investigator-initiated **Phase 2 trial** in combination with pembrolizumab for **metastatic melanoma and HNSCC**, following **promising partial responses** in the GALLANT-1 trial (Part A) with atezolizumab[89](index=89&type=chunk)[90](index=90&type=chunk)[92](index=92&type=chunk) Operating Expenses Comparison (in thousands) | Operating Expense | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (Amount) | Change (Percent) | | :---------------- | :------------------------------- | :------------------------------- | :-------------- | :--------------- | | R&D | $1,465 | $1,834 | $(369) | -20.1% | | G&A | $1,956 | $2,775 | $(819) | -29.5% | | Restructuring | $0 | $968 | $(968) | -100.0% | | Total | $3,421 | $5,577 | $(2,156) | -38.7% | | Operating Expense | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (Amount) | Change (Percent) | | :---------------- | :----------------------------- | :----------------------------- | :-------------- | :--------------- | | R&D | $2,143 | $4,297 | $(2,154) | -50.1% | | G&A | $3,877 | $6,053 | $(2,176) | -35.9% | | Restructuring | $0 | $968 | $(968) | -100.0% | | Total | $6,020 | $11,318 | $(5,298) | -46.8% | [Overview](index=21&type=section&id=Overview) [GB3226](index=21&type=section&id=GB3226) [GB1211](index=23&type=section&id=GB1211) [Financial Overview](index=24&type=section&id=Financial%20Overview) [Components of Operating Results](index=26&type=section&id=Components%20of%20Operating%20Results) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) [Critical Accounting Policies and Significant Judgments and Estimates](index=38&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) [Recently Adopted Accounting Pronouncements](index=42&type=section&id=Recently%20Adopted%20Accounting%20Pronouncements) [Emerging Growth Company and Smaller Reporting Company Status](index=42&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) [Effects of Inflation](index=42&type=section&id=Effects%20of%20Inflation) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Galecto, as a smaller reporting company, is exempt from providing quantitative and qualitative market risk disclosures - Galecto, Inc. is a **smaller reporting company** and is therefore **not required** to provide quantitative and qualitative disclosures about market risk[155](index=155&type=chunk) [Item 4. Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management found disclosure controls effective, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were **effective** at the **reasonable assurance level** as of June 30, 2025[156](index=156&type=chunk) - There have been **no material changes** in internal control over financial reporting during the most recently completed fiscal quarter[158](index=158&type=chunk) [PART II. OTHER INFORMATION](index=44&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) Galecto is not currently involved in any material legal matters or claims - The company is **not currently involved** in any **material legal matters or claims**[160](index=160&type=chunk) [Item 1A. Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) No material changes or additions to previously disclosed risk factors have occurred - **No material changes or additions** to the risk factors have occurred since the previous filings[161](index=161&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) IPO proceeds funded working capital and clinical development; no recent unregistered equity sales or repurchases - The company completed its **IPO** on **November 2, 2020**, raising **$86.3 million** in net proceeds[163](index=163&type=chunk) - As of **June 30, 2025**, **$79.5 million** of IPO net proceeds have been used for **general working capital** and funding **clinical development programs**, including **GB3226** and **GB1211**[164](index=164&type=chunk) - **No sales** under the **ATM Program** occurred during the reported periods, and there were **no purchases** of equity securities by the issuer or affiliated purchasers[124](index=124&type=chunk)[165](index=165&type=chunk) [Item 3. Defaults Upon Senior Securities](index=44&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Galecto reported no defaults upon senior securities - There were **no defaults** upon senior securities[166](index=166&type=chunk) [Item 4. Mine Safety Disclosures](index=44&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are **not applicable** to the company[167](index=167&type=chunk) [Item 5. Other Information](index=44&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - **No officers or directors** adopted, modified, or terminated any **Rule 10b5-1 or non-Rule 10b5-1 trading arrangements** during the three months ended June 30, 2025[168](index=168&type=chunk) [Item 6. Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certifications and XBRL documents - Exhibits include **certifications** from the Principal Executive Officer and Principal Financial Officer (31.1, 31.2, 32.1) and Inline **XBRL documents** (101.INS, 101.SCH, 104)[169](index=169&type=chunk)

Core Viewpoint - Galecto, Inc. reported its operating and financial results for Q1 2025, highlighting advancements in its drug development pipeline, particularly GB3226 for AML, and a significant reduction in operating expenses compared to the previous year [1][2]. Financial Performance - Cash and cash equivalents as of March 31, 2025, were approximately $11.9 million, down from $14.2 million as of December 31, 2024 [3][11]. - Research and development expenses decreased to $0.7 million in Q1 2025 from $2.5 million in Q1 2024, a reduction of $1.8 million attributed to lower preclinical studies and personnel costs [4]. - General and administrative expenses also fell to $1.9 million in Q1 2025 from $3.3 million in Q1 2024, a decrease of $1.4 million primarily due to reduced personnel and legal costs [5]. - The net loss attributable to common stockholders for Q1 2025 was $2.5 million, or $(1.92) per share, compared to a net loss of $5.5 million, or $(5.05) per share, in the prior year [6][12]. Drug Development Progress - The company is advancing GB3226, a dual ENL-YEATS and FLT3 inhibitor for AML, with preclinical studies showing significant efficacy improvements over current treatments [2]. - The planned IND submission for GB3226 is on track for Q1 2026, with expectations for the drug to serve as both a monotherapy and a combination therapy [2]. Company Overview - Galecto is focused on developing novel treatments for oncology and liver diseases, with a pipeline that includes first-in-class small molecule drug candidates targeting cancer and fibrosis [7].

For the transition period from _______________ to _______________ Commission File Number: 001-39655 GALECTO, INC. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact Name of Registrant as Specified in its Charter) | Delaware | 37-195700 ...

Completed strategic review to focus on oncology and liver diseases with the acquisition of global rights to GB3226 (formerly BRM-1420), a dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of AML from Bridge MedicinesGB3226 on track for IND submission in Q1 2026Phase 2 investigator-initiated trial (IIT) of GB1211 in combination with pembrolizumab (Keytruda®) in metastatic melanoma and head and neck squamous cell carcinoma continues to enroll patients BOSTON, March 19, 2025 (GLOBE NEWSWIRE) -- Ga ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39655 GALECTO, INC. (Exact name of Registrant as specified in its Charter) | Delaware | 37-1957007 | | --- | --- | | (State or other ...

BOSTON, Feb. 06, 2025 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for cancer and severe liver diseases, today announced that the Company management team will participate in the following upcoming investor conferences: Oppenheimer 35th Annual Healthcare Life Sciences ConferenceFormat: Corporate Presentation and One-on-One MeetingsDate and Time: Wednesday, February 12 at 8:40-9:10 AM Location: Virtual A live webcast of ...

The price trend for Galecto, Inc. (GLTO) has been bearish lately and the stock has lost 5.8% over the past two weeks. However, the formation of a hammer chart pattern in its last trading session indicates that the stock could witness a trend reversal soon, as bulls might have gained significant control over the price to help it find support.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street an ...

-  Completed strategic review to focus on oncology and severe liver diseases -  Announced acquisition of global rights to BRM-1420, a dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of AML from Bridge Medicines -  Appointed Dr. Amy Wechsler to the Board of Directors and Matthew Kronmiller as Executive Vice President of Strategy and Chief Business Officer BOSTON, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of ...

BOSTON, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for cancer and fibrosis, today announced the appointment of Dr. Amy Wechsler to its Board of Directors. Dr. Wechsler brings a unique combination of expertise and a proven track record of leadership in the healthcare industry. "We are thrilled to welcome Dr. Wechsler to our Board of Directors," said Dr. Carl Goldfischer, Chair of the Board of Galecto. " ...

Core Insights - Galecto, Inc. is refocusing its strategy on cancer and liver disease, utilizing its clinical-stage asset GB1211, which has shown positive results in non-small cell lung cancer and decompensated cirrhosis studies [1][2] - The company has acquired global rights to BRM-1420, a novel dual ENL-YEATS and FLT3 inhibitor, which has demonstrated potential for enhanced clinical effectiveness in treating multiple genetic subsets of acute myeloid leukemia (AML) [1][2] - BRM-1420 has shown synergistic effects with standard-of-care therapies in preclinical models, addressing significant unmet medical needs in AML [1][5] Company Strategy - The strategic review concluded that focusing on GB1211 and acquiring complementary assets like BRM-1420 would maximize value and improve patient outcomes [2] - The acquisition of BRM-1420 involved issuing 62,594 shares of common stock and 160,562 shares of newly-issued Series A preferred stock convertible into common stock, representing approximately 12.8% of Galecto's common stock [2][3] Pipeline Development - Galecto plans to file an Investigational New Drug (IND) application for BRM-1420 in the US by late 2025 or early 2026, with subsequent clinical studies in AML patients [6] - The company continues to develop GB1211, which is currently in a Phase 2 trial in combination with pembrolizumab for treating unresectable or metastatic melanoma and recurrent or metastatic head and neck squamous cell carcinoma [7][8] - Galecto has decided not to advance its LOXL-2 inhibitor candidate GB2064 at this time as part of its strategic review [9] Product Details - BRM-1420 is a selective inhibitor targeting multiple genetic subsets of AML, showing potent activity in various cell lines and potential for superior efficacy compared to existing treatments [5] - The drug targets mutations that account for over 30% of the AML patient population, addressing significant treatment challenges [5]