1. BOSTON, Sept. 15, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that Hans Schambye, the Company's Chief Executive Officer, will be presenting on Tuesday, September 28, 2021 at 8:40 AM ET and will be available for 1x1 meetings on the same date.

    A live audio webcast will be available on the "Webcasts & Presentations" section of Galecto's Investor website at https://ir.galecto.com/news-and-events/events. A replay of the presentation will be available on this same website following the event.

    About Galecto
    Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based…

    BOSTON, Sept. 15, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that Hans Schambye, the Company's Chief Executive Officer, will be presenting on Tuesday, September 28, 2021 at 8:40 AM ET and will be available for 1x1 meetings on the same date.

    A live audio webcast will be available on the "Webcasts & Presentations" section of Galecto's Investor website at https://ir.galecto.com/news-and-events/events. A replay of the presentation will be available on this same website following the event.

    About Galecto

    Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 and LOXL2. Galecto has multiple ongoing Phase 2 clinical programs in fibrosis and cancer, including (i) an inhaled galectin-3 modulator (GB0139) in a phase 2b trial for the treatment of idiopathic pulmonary fibrosis (IPF); (ii) an orally active LOXL2 inhibitor (GB2064) in a phase 2 trial for the treatment of myelofibrosis; (iii) an orally active galectin-3 inhibitor (GB1211) in a phase 1b/2a trial in liver cirrhosis and expected to be evaluated in a phase 2 trial for the treatment of NSCLC in combination with an anti-PD1/-L1 product.

    Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com.

    For more information, contact:

    Galecto, Inc.

    Hans Schambye, CEO

    Jon Freve, CFO

    +45 70 70 52 10
     
     
     
      
    Investor Relations US

    Ashley R. Robinson

    arr@lifesciadvisors.com

    +1 617 430 7577
    Investor/Media Relations EU

    Sandya von der Weid

    svonderweid@lifesciadvisors.com

    +44 78 680 0538

     

     



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  2. BOSTON, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a publicly listed company focused on the development of novel treatments for fibrosis and cancer, today announced that the first patient has been treated with the galectin-3 inhibitor GB1211 in the Phase 1b/2a GULLIVER-2 trial. This trial marks the initiation of Galecto's clinical program for GB1211 in liver cirrhosis. Top line data from the full trial is expected in the second half of 2022.

    "We are very pleased with the continued momentum of our clinical programs and the start of this important study in liver cirrhosis," said Dr. Hans Schambye, CEO of Galecto. "The initiation of this trial follows our strategy of targeting indications with high unmet medical need based…

    BOSTON, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a publicly listed company focused on the development of novel treatments for fibrosis and cancer, today announced that the first patient has been treated with the galectin-3 inhibitor GB1211 in the Phase 1b/2a GULLIVER-2 trial. This trial marks the initiation of Galecto's clinical program for GB1211 in liver cirrhosis. Top line data from the full trial is expected in the second half of 2022.

    "We are very pleased with the continued momentum of our clinical programs and the start of this important study in liver cirrhosis," said Dr. Hans Schambye, CEO of Galecto. "The initiation of this trial follows our strategy of targeting indications with high unmet medical need based on solid biological evidence. Galecto now has three different drug candidates in three phase 2 clinical trials, highlighting the breadth of our product portfolio, and we plan to initiate a second Phase 2 trial of GB1211 in combination with a PD-1/-L1 checkpoint inhibitor for the treatment of non-small-cell lung cancer (NSCLC) during the first half of 2022."

    The GULLIVER-2 trial (NCT05009680) will assess the safety, tolerability, pharmacokinetics and efficacy of GB1211 in up to 54 participants, including liver cirrhosis patients with moderate or severe hepatic impairment (Child Pugh classes B and C). The trial will randomize liver cirrhosis patients of any etiology and evaluate the impact of GB1211 on liver fibrosis and liver function.

    Galectin-3 plays a key role in fibrosis development through cellular activation and the production of collagen, and Galecto has demonstrated that inhibiting the galectin-3 target with GB1211 reduces fibrosis in multiple animal models. Galectin-3 is elevated in cirrhosis patients and is a prognostic biomarker of hepatocellular carcinoma, a known complication of liver cirrhosis.

    It is estimated that more than 100 million patients suffer from liver cirrhosis worldwide and the mortality rate is high. There are no approved disease modifying therapies and liver transplantation remains the sole option for late stage liver cirrhosis.

    About GB1211

    Galecto is developing GB1211, an orally available potent galectin-3 inhibitor. GB1211 has the potential to treat multiple types of cancer and fibrotic diseases. Galecto's initial target indications for GB1211 are NSCLC, a cancer indication with a high unmet need, and liver cirrhosis, a severe, progressive disease that ultimately leads to liver failure.

    GB1211 demonstrated an anti-cancer effect and antifibrotic activity in multiple preclinical models and has successfully completed a Phase 1 trial in 78 healthy volunteers. In the Phase 1 trial, GB1211 was well-tolerated and had dose-dependent pharmacokinetics.

    About Galectin-3 in Liver Cirrhosis

    Galectin-3 has been shown to play a central role in fibrotic diseases, including liver cirrhosis. Preclinical evidence suggests that galectin-3 is required for TGF-beta-mediated activation of myofibroblasts and subsequent matrix production in liver fibrosis. Inhibition of galectin-3 reduces YKL-40, a chitin-like glycoprotein biomarker of liver fibrosis, and reduces the development of fibrosis.

    About Galecto

    Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 and LOXL2. Galecto has multiple ongoing Phase 2 clinical programs in fibrosis and cancer, including (i) an inhaled galectin-3 modulator (GB0139) in a phase 2b trial for the treatment of idiopathic pulmonary fibrosis (IPF); (ii) an orally active LOXL2 inhibitor (GB2064) in a phase 2 trial for the treatment of myelofibrosis; (iii) an orally active galectin-3 inhibitor (GB1211) in a phase 1b/2a trial in liver cirrhosis and expected to be evaluated in a phase 2 trial for the treatment of NSCLC in combination with an anti-PD1/-L1 product.

    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 the potential efficacy of GB1211; the timing of initiating clinical trials and providing topline data for Galecto's product candidates, including GB1211 in the GULLIVER-2 trial; and Galecto's focus and plans for clinical development of its product candidates and pipeline. 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 Galecto's most recent Annual Report on Form 10-K, filed with the SEC on March 29, 2021. 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:

    Galecto Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 
      
    Investors/USMedia/EU
    Ashley R. Robinson

    arr@lifesciadvisors.com
    Sandya von der Weid

    svonderweid@lifesciadvisors.com
    +1 617 430 7577

    +41 78 680 0538





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  3. BOSTON, Aug. 18, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the treatment of the first patient in a Phase 2a trial of its oral LOXL2 inhibitor GB2064 in myelofibrosis. Myelofibrosis, a form of chronic leukemia, is a rare type of blood cancer in which the normal bone marrow is destroyed by fibrous scar tissue that does not produce blood cells.

    The open label MYLOX-1 trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GB2064 in 16 patients over 9 months. The trial will also assess impact on fibrosis and quantification of the tissue targeting of GB2064, as…

    BOSTON, Aug. 18, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the treatment of the first patient in a Phase 2a trial of its oral LOXL2 inhibitor GB2064 in myelofibrosis. Myelofibrosis, a form of chronic leukemia, is a rare type of blood cancer in which the normal bone marrow is destroyed by fibrous scar tissue that does not produce blood cells.

    The open label MYLOX-1 trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GB2064 in 16 patients over 9 months. The trial will also assess impact on fibrosis and quantification of the tissue targeting of GB2064, as well as other aspects of clinical response in myelofibrosis.

    "We are very pleased to start this Phase 2a trial with GB2064 in myelofibrosis, which marks a further important milestone in the development of Galecto's exciting clinical pipeline. There is a significant unmet need in myelofibrosis, with very few therapeutic alternatives. Fibrosis in the tumor micro-environment remains unaddressed and LOXL2 inhibition could be disease modifying," said Dr. Hans Schambye, CEO of Galecto.

    The current standard of care for myelofibrosis is JAK inhibitors, but questions remain regarding side effects caused by the mechanism of action. LOXL-2 is an attractive target, as it is upregulated in myelofibrosis fibrotic tissue and plays a key role in fibrosis and disease progression in the tumor micro-environment. Focused inhibition of LOXL-2 is believed to be inherently safer than pan-inhibition of all LOX enzymes because some of the iso-enzymes potentially carry important liabilities. Galecto successfully completed the Phase 1 SAD/MAD study of GB2064 in healthy volunteers without observing any safety issues.

    Professor Srdan Verstovsek, MD, PhD of the University of Texas MD Anderson Cancer Center, and the principal investigator of the MYLOX-1 trial, added: "I have long been excited about the prospect of LOXL2 inhibitors in myelofibrosis, and with GB2064 we have a novel and elegant method of inhibiting the enzyme which plays a key fibrotic role. There are a significant number of patients who are in desperate need of novel treatment options and I look forward to further investigating the potential of GB2064 to address this."

    About Galecto

    Galecto is a clinical stage biotechnology company incorporated in the U.S. that is developing small molecule-based galectin inhibitors and the collagen cross-linking enzyme, LOXL2, inhibitors. Galecto has multiple clinical programs in fibrosis and cancer focused on galectin-3 and LOXL2, including an inhaled galectin-3 modulator (GB0139) currently in a phase 2b trial for the potential treatment of idiopathic pulmonary fibrosis.  The company's pipeline also includes an orally active galectin-3 inhibitor (GB1211) that is expected to be part of (i) a phase 2 trial for the potential treatment of NSCLC in combination with an anti-PD1/-L1 product and (ii) a phase 1b/2 trial in liver cirrhosis, as well as an orally active LOXL2 inhibitor (GB2064) that is expected to part of a phase 2 trial (the MYLOX-1 trial) for the potential treatment of myelofibrosis.

    Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com.

    The MYLOX-1 Trial

    The MYLOX-1 trial is an open label trial focusing on safety in patients who are intolerant to or ineligible for JAK1 inhibitor therapy. The trial will include safety measures as per the state of the art MRI for spleen size and bone marrow sampling for measurement of fibrosis and of drug presence.

    https://www.clinicaltrials.gov/ct2/show/NCT04679870

    About GB2064

    GB2064 is a pseudo-irreversible inhibitor of the LOXL2 enzyme, which means that high plasma concentrations will cancel the enzyme for a disproportionately longer time than the presence of the drug in plasma. This may mean that the risk of potential side effects due to drug remaining in the system could be avoided. GB2064 has been tested in healthy volunteers without finding dose limiting or dose-related tolerability issues.

    About LOXL2

    LOXL2 is an extracellular enzyme, which carries out cross-linking of collagen and elastin fibrils and thus contributes to building and strengthening of the fibrous matrix that is exaggerated in fibrotic disease.

    About Myelofibrosis

    Myelofibrosis is a blood cancer where the normal bone marrow loses its ability to produce life preserving blood cells like erythrocytes, platelets and white blood cells. The bone marrow is destroyed by fibrotic tissue and hence the name Myelofibrosis (myelo- means marrow). Bone marrow transplantation may be possible, but these patients are older and the risks of non-success is high. Therefore, medicines which can help patients to become transfusion free and live longer are needed.

    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 the planned design of the MYLOX-1 trial, the future myelofibrosis market and Galecto's focus, plans for clinical development, product candidates and pipeline. 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 its most recent Annual Report on Form 10-K filed with the SEC on March 29, 2021. 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:

    Galecto Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 
      
    Investors/USMedia/EU
    Ashley R. Robinson

    arr@lifesciadvisors.com
    Sandya von der Weid

    svonderweid@lifesciadvisors.com
    +1 617 430 7577+41 78 680 0538



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  4. BOSTON, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the quarter ended June 30, 2021.

    Hans Schambye, CEO of Galecto, said, "During the second quarter we continued to focus on the execution of our fibrosis and cancer pipeline. Our clinical team was able to effectively work with regulatory authorities on a revised protocol for our Phase 2b GALACTIC-1 trial with GB0139, which allowed us to re-initiate recruitment. GB0139, our most advanced product candidate, is an inhaled small molecule inhibitor of galectin-3 for the treatment of idiopathic pulmonary fibrosis…

    BOSTON, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the quarter ended June 30, 2021.

    Hans Schambye, CEO of Galecto, said, "During the second quarter we continued to focus on the execution of our fibrosis and cancer pipeline. Our clinical team was able to effectively work with regulatory authorities on a revised protocol for our Phase 2b GALACTIC-1 trial with GB0139, which allowed us to re-initiate recruitment. GB0139, our most advanced product candidate, is an inhaled small molecule inhibitor of galectin-3 for the treatment of idiopathic pulmonary fibrosis (IPF). We were also encouraged by the results from a study of GB0139 in COVID-19 patients with compromised lung function. This study confirmed that GB0139 was generally well-tolerated, showed target engagement by reducing plasma galectin-3, had a positive trend on acute lung injury related to COVID-19 with signs of improved lung function and decreased levels of plasma biomarkers similar to those observed in our prior IPF trials. We believe this second data set of biomarkers in patients with compromised lung function strengthens the notion that inhaled GB0139 can rapidly and strongly affect key biological processes such as inflammation, coagulation and fibrosis."

    Dr. Schambye continued, "Beyond our fibrosis programs, we are excited about the advancement of our compounds for the treatment of cancer, beginning with GB1211, a potent small molecule selective oral galectin-3 inhibitor that we are developing for cancer (initially in NSCLC), as well as fibrosis (initially in liver cirrhosis). We believe that both our galectin-3 inhibitors and our collagen-cross linking enzyme, LOXL2, inhibitor could prove to be important tools in the treatment of cancer, as these compounds are designed to enhance the aggressiveness of the immune system on cancer tissue through changing the tumor microenvironment, and also provide direct anti-growth effects on cancer cells. We are on track to have our fibrosis and cancer product candidates in four separate Phase 2 clinical trials by early 2022."

    Recent Highlights & Developments

    • Announced that Galecto has resumed recruiting IPF patients in its GALACTIC-1 Phase 2b trial under a revised protocol that was submitted to the U.S. Food and Drug Administration and other regulatory bodies. Galecto believes that GB0139 is well positioned to address a significant unmet need for a safer and more efficacious treatment.
    • Announced the results of GB0139 in COVID-19 patients with compromised lung function, which confirmed that the compound was well-tolerated and showed target engagement and highly relevant biological effects.

    Expected Upcoming Milestones

    • Completion of enrollment in GALACTIC-1 Phase 2b clinical trial in IPF patients in 1H 2022
    • Initiation of enrollment in three Phase 2 trials:
      • MYLOX-1 trial (myelofibrosis) in Q3 2021
      • GULLIVER-2 trial (liver cirrhosis) by Q4 2021
      • GALLANT-1 trial (NSCLC) by Q2 2022

    Second Quarter 2021 Financial Highlights

    Cash, cash equivalents, and marketable securities as of June 30, 2021 were approximately $138 million. We currently expect that our cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital requirements into the second half of 2024.

    Research and development expenses were $8.6 million for the three months ended June 30, 2021, compared to $4.5 million for the three months ended June 30, 2020. The increase of $4.1 million was due primarily to increased clinical spending associated with the GALACTIC-1 study.

    General and administrative expenses were $3.6 million for the three months ended June 30, 2021, compared to $1.8 million for the three months ended June 30, 2020. The increase of $1.8 million was primarily related to public company costs and non-cash stock-based compensation.

    Net loss attributable to common stockholders for the three months ended June 30, 2021 was $12.3 million, or $(0.49) per basic and diluted share, compared with $5.9 million, or $(22.83) per basic and diluted share, for the prior year period.

    About Galecto

    Galecto is a clinical stage biotechnology company incorporated in the U.S. that is developing small molecule-based galectin inhibitors and the collagen cross-linking enzyme, LOXL2, inhibitors. Galecto has multiple clinical programs in fibrosis and cancer focused on galectin-3 and LOXL2, including an inhaled galectin-3 modulator (GB0139) currently in a phase 2b trial for the potential treatment of idiopathic pulmonary fibrosis. The company's pipeline also includes an orally active galectin-3 inhibitor (GB1211) that is expected to be part of (i) a phase 2 trial for the potential treatment of NSCLC in combination with an anti-PD1/-L1 product and (ii) a phase 1b/2a trial in liver cirrhosis, as well as an orally active LOXL2 inhibitor (GB2064) that is expected to part of a phase 2 trial for the potential treatment of myelofibrosis.

    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 the company's observations from its COVID-19 study and the relation of such observations to the treatment of patients with compromised lung function or IPF; GB0139 being well positioned to address a significant unmet need for a safer and more efficacious treatment; the potential role of galectin-3 and LOXL2 inhibitors in the treatment of cancer; Galecto's ability to complete of enrollment in GALACTIC-1 Phase 2b clinical trial in IPF patients in 1H 2022; Galecto's initiation of enrollment in three Phase 2 trials: MYLOX-1 trial (myelofibrosis) in Q3 2021, GALLANT-1 trial (NSCLC) by Q2 2022 and GULLIVER-2 trial (liver cirrhosis) by Q4 2021; and Galecto's expectation that it cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital requirements into the second half of 2024. Such forward-looking statements include statements about Galecto's focus, plans for clinical development, product candidates and pipeline. 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 29, 2021. 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:

    Galecto, Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 




    Investor Relations US




    Investor/Media Relations EU
    Ashley R. Robinson

    arr@lifesciadvisors.com
    Sandya von der Weid

    svonderweid@lifesciadvisors.com
    +1 617 430 7577+41 78 680 0538

    Financial Tables to Follow



    GALECTO, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)

     June 30, December 31,
     2021 2020
     (unaudited)  
    Cash and cash equivalents$68,638 $163,582
    Marketable securities 33,176  
    Prepaid expenses and other current assets 5,895  5,713
    Marketable securities, long-term 35,860  
    Operating lease right-of-use assets 1,075  885
    Other assets 2,178  1,416
    Total assets$146,822 $171,596
        
    Current liabilities$4,755 $5,566
    Operating lease liabilities, noncurrent 635  541
    Total liabilities 5,390  6,107
    Total stockholders' equity 141,432  165,489
    Total liabilities and stockholders' equity$146,822 $171,596





    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,
     For the Six Months Ended

    June 30,
      2021   2020   2021   2020 
    Operating expenses:       
    Research and development$8,635  $4,515  $18,625  $9,222 
    General and administrative 3,633   1,823   7,195   2,946 
    Total operating expenses 12,268   6,338   25,820   12,168 
    Loss from operations (12,268)  (6,338)  (25,820)  (12,168)
    Total other income (expense), net (34)  403   173   559 
    Net loss (12,302)  (5,935)  (25,647)  (11,609)
    Net loss per common share, basic and diluted$(0.49) $(22.83) $(1.02) $(44.66)
    Weighted-average number of shares used in computing net loss per common share, basic and diluted 25,261,832   259,966   25,261,832   259,966 
    Other comprehensive gain (loss), net of tax 176   15   (428)  (195)
    Total comprehensive loss$(12,126) $(5,920) $(26,075) $(11,804)


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  5. BOSTON, July 13, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a publicly listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that it has resumed recruitment in its Phase 2b GALACTIC-1 trial of GB0139 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) under a revised protocol that was submitted to the U.S. Food and Drug Administration and other regulatory bodies, including those in Australia, Germany, Spain and the United Kingdom. Following the recommendation from an independent Data Safety Monitoring Board in March 2021 to modify the GALACTIC-1 trial protocol, 38 patients continued treatment in this Phase 2b trial. Under the revised protocol, Galecto is now recruiting…

    BOSTON, July 13, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a publicly listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that it has resumed recruitment in its Phase 2b GALACTIC-1 trial of GB0139 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) under a revised protocol that was submitted to the U.S. Food and Drug Administration and other regulatory bodies, including those in Australia, Germany, Spain and the United Kingdom. Following the recommendation from an independent Data Safety Monitoring Board in March 2021 to modify the GALACTIC-1 trial protocol, 38 patients continued treatment in this Phase 2b trial. Under the revised protocol, Galecto is now recruiting additional patients who are not taking nintedanib or pirfenidone at screening, who will be randomized 2:1 to receive either GB0139 3 mg or placebo.

    GALACTIC-1 is a 52-week randomized, double-blind, multicenter, parallel, placebo-controlled Phase 2b trial being conducted across more than 100 centers globally, investigating the safety and efficacy of Galecto's lead inhaled compound, GB0139, in up to 210 patients with IPF. The revised trial design retains the same statistical powering to assess the primary endpoint of forced vital capacity (FVC) decline over 52 weeks. Galecto anticipates that topline data from the GALACTIC-1 trial will be available by mid-2023.

    "We are pleased to continue our Phase 2b GALACTIC-1 trial of GB0139 in IPF patients. We believe the 3 mg dose of GB0139, as a single agent, has the potential to be an effective and potentially life-changing treatment. In our previous study of GB0139 in IPF patients, we showed that the 3 mg dose is well-tolerated and easy to administer for the patients. We observed target engagement at that dose level, with a decrease in lung macrophage Galectin-3 levels, as well as reduction in a number of fibrosis biomarkers, including YKL-40, PDGF, and PAI-1. Additionally, we recently announced the results of GB0139 in COVID-19 patients with compromised lung function, which confirmed that the compound was well-tolerated and showed target engagement and highly relevant biological effects," said Dr. Hans Schambye, CEO of Galecto. "Around 50% of IPF patients in Europe and the US do not receive treatment with either pirfenidone or nintedanib, representing a significant unmet medical need. We are confident in the safety of the 3 mg GB0139 dose based on our previous clinical results and the blinded data in the GALACTIC-1 trial. We are looking forward to continuing to investigate this exciting drug candidate."

    GB0139

    GB0139 is the world's first small molecule galectin-3 inhibitor studied in man. The compound is not taken up via the oral route and is being developed as an inhaled therapeutic in Idiopathic Pulmonary Fibrosis (https://clinicaltrials.gov/ct2/show/NCT03832946). Early phase studies have shown that inhalation of GB0139 in healthy volunteers and in IPF patients is well tolerated, and the phase 2a IPF trial showed significant effects on several biomarkers linked to worse outcomes in IPF.

    About Galecto

    Galecto is a clinical stage biotechnology company incorporated in the U.S. that is developing small molecule-based galectin inhibitors and the collagen cross-linking enzyme, LOXL2, inhibitors. Galecto has multiple clinical programs in fibrosis and cancer focused on galectin-3 and LOXL2, including an inhaled galectin-3 modulator (GB0139) currently in a phase 2b trial for the potential treatment of idiopathic pulmonary fibrosis. The company's pipeline also includes an orally active galectin-3 inhibitor (GB1211) that is expected to be part of (i) a phase 2 trial for the potential treatment of NSCLC in combination with an anti-PD1 product and (ii) a phase 1b/2 trial in liver cirrhosis, as well as an orally active LOXL2 inhibitor (GB2064) that is expected to part of a phase 2 trial for the potential treatment of myelofibrosis. It is anticipated that enrollment for all of these trials will be initiated in 2021.

    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 the GALACTIC-1 trial, including plans for resuming enrollment of patients, the timing of completing enrollment and releasing topline data, as well as GB0139's potential (including the safety and effectiveness of the 3 mg dose). 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, their therapeutic potential and outcomes related to our clinical trials, our ability to continue to enroll patients and complete the GALACTIC-1 trial with fewer dosage groups, the risk that FDA or other regulatory agency imposes a clinical hold on the GALACTIC-1 trial, having adequate funds and their use, and those additional risks and uncertainties disclosed in Galecto's filings with the Securities and Exchange Commission. 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: 
      
    Galecto Inc. 
    Hans Schambye, CEO 
    Jon Freve, CFO 
    +45 70 70 52 10 
      
    Investors/USMedia/EU
    Ashley R. RobinsonMary-Ann Chang
    arr@lifesciadvisors.commchang@lifesciadvisors.com
    +1 617 430 7577+44 7483 284 853



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    • GB0139 significantly reduced oxygen flow requirements and improved several biomarkers for lung and systemic inflammation, liver function, tissue damage and coagulation
    • Data demonstrate potential of GB0139 in patients with viral-induced acute lung injury
    • Currently Galecto will prioritize resources for its four phase 2 trials in fibrosis and cancer

    BOSTON and COPENHAGEN, Denmark, June 22, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a publicly listed, clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced preliminary topline results from an investigator-initiated trial examining Galecto's inhaled galectin-3 inhibitor (GB0139). This trial included 41 hospitalized patients…

    • GB0139 significantly reduced oxygen flow requirements and improved several biomarkers for lung and systemic inflammation, liver function, tissue damage and coagulation

    • Data demonstrate potential of GB0139 in patients with viral-induced acute lung injury
    • Currently Galecto will prioritize resources for its four phase 2 trials in fibrosis and cancer

    BOSTON and COPENHAGEN, Denmark, June 22, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a publicly listed, clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced preliminary topline results from an investigator-initiated trial examining Galecto's inhaled galectin-3 inhibitor (GB0139). This trial included 41 hospitalized patients with COVID-19 infection who did not require mechanical ventilation, of which 20 were randomized to the GB0139 arm.

    GB0139, dosed at 10 mg twice a day for 2 days and subsequently once a day for up to 14 days, showed a favorable safety profile with no treatment-related serious adverse events reported. GB0139 had a positive trend on acute lung injury related to COVID-19, as patients who received GB0139 showed signs of improved lung function with a significant decline in oxygen flow requirements compared to patients only receiving standard of care (SOC), which included dexamethasone, remdesivir and anticoagulant therapy.

    GB0139 showed target engagement by reducing galectin-3 levels compared to SOC (p < 0.01). Patients with COVID-19 were able to inhale GB0139 and achieve consistent exposure of GB0139 at levels previously associated with systemic biomarker responses in IPF patients (including YKL-40 and PAI-1). Patients showed improved inflammation and coagulation biomarkers, including CXCL10, thrombocytes and reduced D-dimers, as well as improved biomarkers of liver function and tissue damage. While the severity of the disease at baseline was worse in patients receiving GB0139, these patients had similar outcomes to patients receiving only SOC.

    Bertil Lindmark, Chief Medical Officer of Galecto, stated, "Galectin-3 has been linked to several disease mechanisms in COVID-19 that correlate to disease severity. It is exciting to see improvements in anti-inflammatory, anti-thrombotic and organ function parameters over and above those seen in SOC. This illustrates the potential of galectin-3 inhibition in patients with acute lung injury and supports further assessment of GB0139 in viral-induced acute lung injury, including that caused by COVID-19."

    In a post-hoc subgroup analysis of patients with moderate to severe COVID-19 infection, there was a 21% reduction in mortality in patients treated with GB0139 vs SOC. Furthermore, patients had reductions in CXCL10, IL-6, IL-10 and TNFα, suggesting that GB0139 has the potential to counter the cytokine storm and prevent acute respiratory distress syndrome and multi-organ failure. GB0139 also reduced PAI-1 and YKL-40 levels – as previously observed in Galecto's phase 2a trial in IPF patients. These markers are associated with a high risk of thrombosis and fibrosis, suggesting that GB0139 may reduce lung fibrosis seen in COVID-19 patients. This data together suggests GB0139 could result in clinical improvement in moderate to severe COVID-19 patients by reducing inflammation, improving lung and other organ function and reducing the risk of cytokine storm and micro-thrombosis.

    Dr. Hans Schambye, President and Chief Executive Officer of Galecto, commented, "We were pleased that the safety and tolerability of GB0139 10 mg was further confirmed with early biomarker signs, which are in line with our previously reported IPF data. It is highly encouraging that we have now demonstrated in two separate clinical trials, IPF and COVID-19, that GB0139 can be dosed in patients with compromised lung function, and that the compound shows target engagement and highly relevant biological effects. Given the continued evolution of the COVID landscape, we believe that it is prudent to focus our financial and human resources on our exciting phase 2 pipeline of fibrosis and cancer treatments, including IPF, myelofibrosis, NSCLC and liver cirrhosis." Dr. Schambye added, "We will continue to pursue opportunities relating to viral-induced acute lung injury and also explore external options for partnering and/or funding additional COVID-19 activities."

    It is anticipated that additional data from this trial will be released at a scientific conference later in 2021.

    COVID-19 Trial

    In this open-label trial (https://clinicaltrials.gov/ct2/show/NCT04473053), 41 patients were randomized to receive either standard of care or inhaled GB0139 (dosed at 10 mg twice a day for 2 days and subsequently once a day for up to 14 days) plus standard of care, to evaluate the safety and tolerability of GB0139, pharmacokinetics, and its effects on clinical outcomes and biomarkers.

    About Galecto

    Galecto is a clinical stage biotechnology company incorporated in the U.S. that is developing small molecule-based galectin inhibitors and the collagen cross-linking enzyme, LOXL2, inhibitors. Galecto has multiple clinical programs in fibrosis and cancer focused on galectin-3 and LOXL2, including an inhaled galectin-3 modulator (GB0139) currently in a phase 2b trial for the potential treatment of idiopathic pulmonary fibrosis.  The company's pipeline also includes an orally active galectin-3 inhibitor (GB1211) that is expected to be part of (i) a phase 2 trial for the potential treatment of NSCLC in combination with an anti-PD1 product and (ii) a phase 1b/2 trial in liver cirrhosis, as well as an orally active LOXL2 inhibitor (GB2064) that is expected to part of a phase 2 trial for the potential treatment of myelofibrosis. It is anticipated that enrollment for all of these trials will be initiated in 2021.

            

    GB0139

    GB0139 is the world's first small molecule galectin-3 inhibitor studied in man. The compound is not taken up via the oral route and is being developed as an inhaled therapeutic in Idiopathic Pulmonary Fibrosis (https://clinicaltrials.gov/ct2/show/NCT03832946). Early phase studies have shown that inhalation of GB0139 in healthy volunteers and in IPF patients is well tolerated, and the phase 2a IPF study showed significant effects on several biomarkers linked to worse outcomes in IPF.

    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 the tolerability and efficacy of GB0139 in COVID-19 lung inflammation; the potential of galectin-3 inhibition in patients with acute lung injury; that GB0139 may reduce lung fibrosis seen in COVID-19 patients; that GB0139 has the potential to counter the cytokine storm and prevent acute respiratory distress syndrome and multi-organ failure; and Galecto's focus and plans for clinical development of its product candidates and pipeline. 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. 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:

    Galecto Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 


    Investors/US


    Media/EU
    Ashley R. Robinson

    arr@lifesciadvisors.com
    Mary-Ann Chang

    mchang@lifesciadvisors.com
    +1 617 775 5956+44 7483 284 853

     



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  6. BOSTON, June 02, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that it will host a key opinion leader (KOL) webinar on the myelofibrosis treatment landscape and the current and potential future treatments on Wednesday, June 9, 2021 at 8am Eastern Time.

    The webinar will feature a presentation by KOL Srdan Verstovsek, MD, Ph.D., UT MD Anderson Cancer Center, who will discuss the current treatment landscape and unmet medical need in treating patients with myelofibrosis, a fibrosis-related blood cancer. He will also discuss the opportunity for Galecto's GB2064 as a potential treatment option and Hans Schambye…

    BOSTON, June 02, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that it will host a key opinion leader (KOL) webinar on the myelofibrosis treatment landscape and the current and potential future treatments on Wednesday, June 9, 2021 at 8am Eastern Time.

    The webinar will feature a presentation by KOL Srdan Verstovsek, MD, Ph.D., UT MD Anderson Cancer Center, who will discuss the current treatment landscape and unmet medical need in treating patients with myelofibrosis, a fibrosis-related blood cancer. He will also discuss the opportunity for Galecto's GB2064 as a potential treatment option and Hans Schambye, Galecto's President and CEO, will update its development status.

    Dr. Verstovsek will be available to answer questions following the formal presentations with Galecto's management team.

    GB2064 is an oral LOXL2 inhibitor that the company plans to examine in a Phase 2a study for the treatment of myelofibrosis. LOXL-2 is upregulated in myelofibrosis fibrotic tissue and plays a key role in fibrosis and disease progression in the tumor micro-environment; and as such, inhibiting LOXL-2 may restore bone marrow function and be disease-modifying. The current standard of care for myelofibrosis is JAK inhibitors, but their use is limited by side effects and loss of efficacy in many patients.

    To register for the webinar, please click here.

    Dr. Srdan Verstovsek is the United Energy Resources, Inc., Professor of Medicine and a Professor in the Department of Leukemia, Division of Cancer Medicine, Director of the Hanns A. Pielenz Clinical Research Center for Myeloproliferative Neoplasms (MPN), and Chief of the Section for MPN at the University of Texas MD Anderson Cancer Center. He is also founder/Director of the largest MPN Clinical Research Center worldwide.

    Dr. Verstovsek has achieved international acclaim for his leadership in developing landmark MPN therapeutics. He has led more than 60 early/advanced phase clinical trials of novel MPN drugs including the clinical development of the JAK1/2 inhibitor fuxolitinib, the first FDA-approved drug for myelofibrosis. Currently, Dr. Verstovsek is leading several pivotal phase 3 trials for myelofibrosis medications.

    Dr. Verstovsek has published, 4 books, 24 book chapters, and more than 550 peer-reviewed original articles and reviews in leading medical journals such as the New England Journal of Medicine, Blood, Leukemia, and Lancet. Dr. Verstovsek holds 3 patents for cancer and leukemia treatments.

    Dr. Verstovsek's contributions in MPN have been globally recognized with numerous invitations as expert speaker/educator/Chair at significant national and international conferences. He regularly engages at multiple levels with MPN patients' advocacy groups/societies. He is Co-Founder/Executive Committee Member of the International Working Group for Myelofibrosis Treatment and Research. Dr. Verstovsek is the recipient of several distinguished awards, including the Otis W. and Pearl L. Walters Faculty Achievement Award in Clinical Research (2017), The University of Texas MD Anderson Cancer Center, and was elected as a member of American Society for Clinical Investigation in 2015.

    About Galecto

    Galecto is a clinical stage biotechnology company incorporated in the U.S. that is developing small molecule-based galectin inhibitors and the collagen cross-linking enzyme, LOXL2, inhibitors. Galecto has multiple clinical programs in fibrosis and cancer focused on galectin-3 and LOXL2, including an inhaled galectin-3 modulator (GB0139) currently in a phase 2b trial for the potential treatment of idiopathic pulmonary fibrosis.  The company's pipeline also includes an orally active galectin-3 inhibitor (GB1211) that is expected to be part of (i) a phase 2 trial for the potential treatment of NSCLC in combination with an anti-PD1 product and (ii) a phase 1b/2 trial in liver cirrhosis, as well as an orally active LOXL2 inhibitor (GB2064) that is expected to part of a phase 2 trial for the potential treatment of myelofibrosis. It is anticipated that enrollment for all of these trials will be initiated in 2021.  

    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 plans to examine GB2064 in a Phase 2a study for the treatment of myelofibrosis. 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. 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:

    Galecto Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 


    Investors/US


    Media/EU
    Ashley R. Robinson

    arr@lifesciadvisors.com
    Mary-Ann Chang

    mchang@lifesciadvisors.com
    +1 617 775 5956+44 7483 284 853



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  7. BOSTON, May 11, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that Garrett Winslow has joined the Company as Senior Vice President, General Counsel. In this role, Mr. Winslow will lead the Company's legal, compliance and enterprise risk management functions, reporting to Hans Schambye, CEO.

    Garrett Winslow brings to Galecto over 15 years of experience working with public companies in the life sciences industry. Prior to joining Galecto, he served as the General Counsel of Spring Bank Pharmaceuticals.  He was also a partner in the Corporate and Securities group at Mintz, Levin, Cohn, Ferris, Glovsky and…

    BOSTON, May 11, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that Garrett Winslow has joined the Company as Senior Vice President, General Counsel. In this role, Mr. Winslow will lead the Company's legal, compliance and enterprise risk management functions, reporting to Hans Schambye, CEO.

    Garrett Winslow brings to Galecto over 15 years of experience working with public companies in the life sciences industry. Prior to joining Galecto, he served as the General Counsel of Spring Bank Pharmaceuticals.  He was also a partner in the Corporate and Securities group at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. in Boston, Massachusetts, where he advised public and private companies on securities law compliance, corporate governance and transactional matters. Mr. Winslow received his Master's in Taxation from Boston University Law School, J.D. degree from Suffolk University Law School and B.A. degree in Business Administration from the University of Washington.

    "We are pleased to welcome Garrett to our senior management team. He is a talented and experienced executive with an in-depth knowledge of the healthcare industry. Importantly, Garrett brings broad legal and regulatory experience, which will help guide us as we progress our clinical development pipeline," said Dr. Hans Schambye, CEO of Galecto

    Mr. Winslow added, "I am excited to join Galecto at this point in their development. Galecto has a rich pipeline of assets moving into Phase 2 development that is supported by a strong balance sheet and a team with a proven ability to execute on its strategy. I look forward to contributing to its success."

    About Galecto

    Galecto is a clinical stage biotechnology company incorporated in the U.S. that is developing small molecule-based galectin inhibitors and the collagen cross-linking enzyme, LOXL2, inhibitors. Galecto has multiple clinical programs in fibrosis and cancer focused on galectin-3 and LOXL2, including an inhaled galectin-3 modulator (GB0139) currently in a phase 2b trial for the potential treatment of idiopathic pulmonary fibrosis.  The company's pipeline also includes an orally active galectin-3 inhibitor (GB1211) that is expected to be part of (i) a phase 2 trial for the potential treatment of NSCLC in combination with an anti-PD1 product and (ii) a phase 1b/2 trial in liver cirrhosis, as well as an orally active LOXL2 inhibitor (GB2064) that is expected to part of a phase 2 trial for the potential treatment of myelofibrosis. It is anticipated that enrollment for all of these trials will be initiated in 2021.  

    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 focus, plans for clinical development, product candidates and pipeline. 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. 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:

    Galecto Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 


    Investors/US
    Media/EU
    Ashley R. Robinson

    arr@lifesciadvisors.com
    Mary-Ann Chang

    mchang@lifesciadvisors.com
    +1 617 775 5956+44 7483 284 853



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  8. BOSTON, May 06, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that members of the Galecto executive team will participate in multiple upcoming investor events.

    Investor Conferences
    Hans Schambye, the Company's Chief Executive Officer, and Jonathan Freve, the Company's Chief Financial Officer, will be available for 1x1 meetings with investors at the following investor conferences:

    Bank of America Securities 2021 Virtual Healthcare Conference – Corporate Presentation on Wednesday, May 12 at 8 AM ET

    Jefferies Virtual Healthcare Conference – Corporate Presentation on Thursday, June 3 at 8:30 AM ET

    SVB Leerink

    BOSTON, May 06, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that members of the Galecto executive team will participate in multiple upcoming investor events.

    Investor Conferences

    Hans Schambye, the Company's Chief Executive Officer, and Jonathan Freve, the Company's Chief Financial Officer, will be available for 1x1 meetings with investors at the following investor conferences:

    Bank of America Securities 2021 Virtual Healthcare Conference – Corporate Presentation on Wednesday, May 12 at 8 AM ET

    Jefferies Virtual Healthcare Conference – Corporate Presentation on Thursday, June 3 at 8:30 AM ET

    SVB Leerink CybeRx Series: Liver Disease Day – Thursday, June 17

    LifeSci Advisors Nordic Biotech Summit – Tuesday, June 29

    Key Opinion Leader Event

    On Wednesday, June 9, Galecto will host a key opinion leader event to discuss the current treatment landscape and unmet clinical need for myelofibrosis, as well as the potential for GB2064, Galecto's LOXL2 inhibitor that is expected to enter a phase 2 trial in the current quarter.  

    A live webcast of the KOL event and available presentations will be posted under the Investor section of the Company's website at www.galecto.com. A replay of each available presentation will be available for 30 days following the event.

    About Galecto

    Galecto is a clinical stage biotechnology company incorporated in the U.S. that is developing small molecule-based galectin inhibitors and the collagen cross-linking enzyme, LOXL2, inhibitors. Galecto has multiple clinical programs in fibrosis and cancer focused on galectin-3 and LOXL2, including an inhaled galectin-3 modulator (GB0139) currently in a phase 2b trial for the potential treatment of idiopathic pulmonary fibrosis.  The company's pipeline also includes an orally active galectin-3 inhibitor (GB1211) that is expected to be part of (i) a phase 2 trial for the potential treatment of NSCLC in combination with an anti-PD1 product and (ii) a phase 1b/2 trial in liver cirrhosis, as well as an orally active LOXL2 inhibitor (GB2064) that is expected to part of a phase 2 trial for the potential treatment of myelofibrosis. It is anticipated that enrollment for all of these trials will be initiated in 2021.  

    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 the timing for initiation of enrollment in three separate Phase 2 trials for myelofibrosis, NSCLC, liver cirrhosis. Such forward-looking statements include statements about Galecto's focus, plans for clinical development, product candidates and pipeline. 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. 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:

    Galecto, Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 
      
    Investor Relations USInvestor/Media Relations EU
    Ashley R. Robinson

    arr@lifesciadvisors.com
    Mary-Ann Chang

    mchang@lifesciadvisors.com
    +1 617 430 7577+44 7483 284 853



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  9. BOSTON, May 04, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the period ended March 31, 2021 and provided a corporate update.

    "The first quarter was one of continued focus on our pipeline, as we look forward to initiating three Phase 2 trials this year and continue building upon our strategy," said Hans Schambye, CEO of Galecto. "As we evaluate and modify our ongoing GALACTIC-1 Phase 2b trial of GB0139 in IPF, we established additional validation of our platform, specifically the role of galectin-3 and its potential in new cancer indications, in a paper published in…

    BOSTON, May 04, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the period ended March 31, 2021 and provided a corporate update.

    "The first quarter was one of continued focus on our pipeline, as we look forward to initiating three Phase 2 trials this year and continue building upon our strategy," said Hans Schambye, CEO of Galecto. "As we evaluate and modify our ongoing GALACTIC-1 Phase 2b trial of GB0139 in IPF, we established additional validation of our platform, specifically the role of galectin-3 and its potential in new cancer indications, in a paper published in a peer-reviewed journal Gastric Cancer. The planned clinical study in non-small cell lung cancer (NSCLC) with our oral galectin-3 inhibitor GB 1211 is very exciting and we are pleased to have a balance sheet supporting development in these meaningful indications."

    Recent Highlights & Developments

    • Published a paper in Gastric Cancer, a joint official peer-reviewed journal of the International gastric Cancer Association and the Japanese Gastric Cancer Association.
    • Announced plans to work with both study investigators and appropriate regulatory authorities to modify and continue the GALACTIC-1 Phase 2b trial following the recommendation from a data safety monitoring board, maintaining our opportunity to demonstrate an effect in the treatment of IPF. We continue to believe that GB0139 is well positioned to address a significant unmet need for a safer and more efficacious treatment.
    • Hosted a well-attended Key Opinion Leader event discussing the current treatment landscape for IPF, the unmet clinical need, and the potential for GB0139. To access a recording of the event please visit the Event page on the Investor tab on Galecto's website or follow this link: https://ir.galecto.com/news-and-events/events

    Expected Upcoming Milestones

    • COVID data in early Q2 2021
    • Completion of enrollment in GALACTIC-1 Phase 2b clinical trial in IPF patients in 2H 2021
    • Initiation of enrollment in three Phase 2 trials:
      • MYLOX-1 trial (myelofibrosis) in 1H 2021
      • GALLANT-1 trial (NSCLC) in 2H 2021
      • GULLIVER-2 trial (liver cirrhosis) in 2H 2021

    Three Months Ended March 31, 2021 Financial Highlights

    Cash, cash equivalents, and investments as of March 31, 2021 were approximately $149 million. We currently expect that our cash and cash equivalents will be sufficient to fund our operating expenses and capital requirements into 2024.

    Research and development expenses were $10.0 million for the three months ended March 31, 2021, compared to $4.7 million for the three months ended March 31, 2020. The increase of $5.3 million was due primarily to increased clinical spending associated with the GALACTIC-1 study.

    General and administrative expenses were $3.6 million for the three months ended March 31, 2021, compared to $1.1 million for the three months ended March 31, 2020. The increase of $2.5 million was primarily related to public company costs and non-cash stock-based compensation.

    Net loss attributable to common stockholders for the three months ended March 31, 2021 was $13.3 million, or $(0.53) per basic and diluted share, compared with $5.7 million, or $(21.83) per basic and diluted share, for the prior year period.

    About Galecto

    Galecto is a clinical stage biotechnology company incorporated in the U.S. that is developing small molecule-based galectin inhibitors and the collagen cross-linking enzyme, LOXL2, inhibitors. Galecto has multiple clinical programs in fibrosis and cancer focused on galectin-3 and LOXL2, including an inhaled galectin-3 modulator (GB0139) currently in a phase 2b trial for the potential treatment of idiopathic pulmonary fibrosis.  The company's pipeline also includes an orally active galectin-3 inhibitor (GB1211) that is expected to be part of (i) a phase 2 trial for the potential treatment of NSCLC in combination with an anti-PD1 product and (ii) a phase 1b/2 trial in liver cirrhosis, as well as an orally active LOXL2 inhibitor (GB2064) that is expected to part of a phase 2 trial for the potential treatment of myelofibrosis. It is anticipated that enrollment for all of these trials will be initiated in 2021.  

    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 the role of galectin-3 and its potential in new cancer indications; the announcement of COVID data in early Q2 2021; our plans to work with both study investigators and appropriate regulatory authorities to modify and continue the GALACTIC-1 Phase 2b trial following the recommendation from a data safety monitoring board and our ability to complete of enrollment in GALACTIC-1 Phase 2b clinical trial in IPF patients in 2H 2021; our initiation of enrollment in three Phase 2 trials: MYLOX-1 trial (myelofibrosis) in 1H 2021, GALLANT-1 trial (NSCLC) in 2H 2021 and GULLIVER-2 trial (liver cirrhosis) in 2H 2021; and our expectation that our cash and cash equivalents will be sufficient to fund our operating expenses and capital requirements into 2024. Such forward-looking statements include statements about Galecto's focus, plans for clinical development, product candidates and pipeline. 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. 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:

    Galecto, Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 


    Investor Relations US


    Investor/Media Relations EU
    Ashley R. Robinson

    arr@lifesciadvisors.com
    Mary-Ann Chang

    mchang@lifesciadvisors.com
    +1 617 775 5956+44 7483 284 853



    Financial Tables to Follow



    GALECTO, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)

     March 31, December 31,
     2021 2020
     (unaudited)  
    Cash and cash equivalents$74,253 $163,582
    Marketable securities 36,081  
    Prepaid expenses and other current assets 6,568  5,713
    Marketable securities, long-term 38,576  
    Operating lease right-of-use assets 933  885
    Other assets 2,244  1,416
    Total assets$158,655 $171,596
        
    Current liabilities$5,540 $5,566
    Operating lease liabilities, noncurrent 544  541
    Total liabilities 6,084  6,107
    Total stockholders' equity 152,571  165,489
    Total liabilities and stockholders' equity$158,655 $171,596
        



    GALECTO, INC.


    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share amounts)

    (unaudited)

     Three Months Ended March 31,
      2021   2020 
    Operating expenses:   
    Research and development$9,990  $4,707 
    General and administrative 3,562   1,123 
    Total operating expenses 13,552   5,830 
    Loss from operations (13,552)  (5,830)
    Total other income (expense), net 207   156 
    Net loss (13,345)  (5,674)
    Net loss per common share, basic and diluted$(0.53) $(21.83)
    Weighted-average number of shares used in computing net loss per common share, basic and diluted 25,261,832   259,966 
    Other comprehensive loss:   
    Net loss (13,345)  (5,674)
    Currency translation loss (524)  (210)
    Unrealized loss on marketable securities (80)   
    Total comprehensive loss$(13,949) $(5,884)
        


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  10. BOSTON, April 15, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the publication of a paper in Gastric Cancer, a joint official peer-reviewed journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, demonstrating the key role galectin-3 plays in gastric cancer.

    The paper, entitled "Crosstalk between WNT and STAT3 is mediated by galectin‑3 in tumor progression", outlines how galectin-3 promotes cancer cell growth through the well-established STAT3-WNT pathway. This paper adds to the growing literature indicating a linkage between high levels of galectin-3 in the tumor…

    BOSTON, April 15, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the publication of a paper in Gastric Cancer, a joint official peer-reviewed journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, demonstrating the key role galectin-3 plays in gastric cancer.

    The paper, entitled "Crosstalk between WNT and STAT3 is mediated by galectin‑3 in tumor progression", outlines how galectin-3 promotes cancer cell growth through the well-established STAT3-WNT pathway. This paper adds to the growing literature indicating a linkage between high levels of galectin-3 in the tumor micro-environment of several cancers, promoting cancer growth, cancer spread and leading to worse prognosis.

    The preclinical research published in Gastric Cancer demonstrates that GB1107, one of Galecto's galectin-3 inhibitors optimized for mouse galectin-3, is potent in inhibiting the cancer promoting effects of galectin-3. The scientific work is a collaboration between Yonsei University and Chosun University, both in South Korea, Lund University and Galecto.

    "We detected increased levels of galectin-3 and STAT3 phosphorylation in the stomach tissues of WNT1-overexpressing mouse models. Furthermore, high expression levels and co-localization of β-catenin, pSTAT3, and galectin-3 in patients with advanced gastric cancer were correlated with a poorer prognosis," said Kyung-Hee Chun, PhD, Professor at Yonsei University and the corresponding author of the paper.

    Dr. Hans Schambye, CEO of Galecto added, "This research is very exciting as it outlines a potential new cancer indication in which galectin-3 plays a key role. In this preclinical study, GB1107, our orally active galectin-3 inhibitor optimized for murine activity, demonstrated the ability to inhibit tumor growth in orthotopic gastric cancer-bearing mice. We believe these data together with existing data on the role of galectin-3 in cancer provide a solid basis for exploring clinical application of our galectin-3 inhibitors in gastric cancer therapy."

    "Galecto is planning to initiate a clinical study in Non-Small-Cell Lung Cancer (NSCLC) with our clinical phase oral galectin-3 inhibitor GB1211, a close analog of the murine GB1107. The promising effects seen in this preclinical study in gastric cancer support the belief that our galectin-3 inhibitors may have broad applicability in many cancer types," continued Dr. Schambye.

    About Galecto

    Galecto is a clinical stage biotechnology company incorporated in the U.S. with advanced programs in fibrosis and cancer centered on galectin-3 and LOXL2. The company's pipeline includes an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis, as well as two additional assets about to move into phase 2.

    Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com.

    About GB1211

    Galecto is developing GB1211, an orally active, specific galectin-3 inhibitor, as a first-in-class direct anti-fibrotic and anti-cancer agent. Phase 1 studies with GB1211 have been successfully completed and Galecto is planning to initiate clinical studies with GB1211 for the treatment of NSCLC and liver cirrhosis in 2021.

    About galectin-3

    Galectin-3 is a member of the galectin family of galactoside binding lectins. Galectin-3 exists both intra- and extracellularly and binds to glycosylated proteins. Galectin-3 has been shown to play a central role in the development and progression of fibrosis and cancer. Abolition of galectin-3 expression in knockout animals or pharmacological blockade using Galecto's inhibitors lead to a dramatic reduction or even prevention of fibrosis and cancer.

    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 focus, plans for clinical development, product candidates and pipeline. 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. 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:

    Galecto Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 




    Investors/US




    Media/EU
    Ashley R. Robinson

    arr@lifesciadvisors.com
    Mary-Ann Chang

    mchang@lifesciadvisors.com
    +1 617 775 5956+44 7483 284 853

     



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  11. BOSTON, March 29, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the year ended December 31, 2020 and provided a corporate update.

    "2020 was an extraordinary year for Galecto, culminating with our successful IPO. This strengthened our balance sheet, brought in new investors, and will allow us to make important progress across all our pipeline assets," said Hans Schambye, CEO of Galecto. "This year, we are planning to initiate three Phase 2 trials, in addition to executing our Phase 2b trial in IPF, a large orphan indication with a clear need for safer and more efficacious…

    BOSTON, March 29, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the year ended December 31, 2020 and provided a corporate update.

    "2020 was an extraordinary year for Galecto, culminating with our successful IPO. This strengthened our balance sheet, brought in new investors, and will allow us to make important progress across all our pipeline assets," said Hans Schambye, CEO of Galecto. "This year, we are planning to initiate three Phase 2 trials, in addition to executing our Phase 2b trial in IPF, a large orphan indication with a clear need for safer and more efficacious treatment options. We firmly believe that GB0139, our inhalable, once-daily therapy, has the potential to provide patients with a convenient, effective treatment for this debilitating and fatal disease. We are also excited about the potential of our other drug candidates to help patients with serious illnesses."

    Recent Highlights & Developments

    • Successfully completed an Initial Public Offering (IPO) with shares beginning trading on the Nasdaq Global Market on October 29, 2020 under the ticker symbol "GLTO." The Company raised approximately $160 million in total funds during the recent IPO and preceding crossover investment round.
    • Strengthened its Board of Directors with the appointments of Dr. Jayson Dallas and Dr. Anne Prener, both seasoned executives with global experience in the pharmaceutical and biotech industries.
    • Published a paper detailing full results from a Phase 2a study of GB0139 in Idiopathic Pulmonary Fibrosis (IPF) in the peer-reviewed publication European Respiratory Journal. The study highlights the effect of inhaled GB0139 on the plasma levels of highly relevant disease biomarkers in IPF patients.
    • Announced plans to work with both the study investigators and the appropriate regulatory authorities to modify and continue the GALACTIC-1 Phase 2b trial following the recommendation from a data safety monitoring board, keeping the opportunity to demonstrate an effect in the treatment of IPF. We continue to believe that GB0139 is well positioned to address a significant unmet need for a safer and more efficacious treatment.

    Expected Upcoming Milestones

    • COVID data in early Q2 2021
    • Completion of enrollment in GALACTIC-1 Phase 2b clinical trial in IPF patients in 2H 2021
    • Initiation of enrollment in three Phase 2 trials:
      • MYLOX-1 trial (myelofibrosis) in 1H 2021
      • GALLANT-1 trial (NSCLC) in 2H 2021
      • GULLIVER-2 trial (liver cirrhosis) in 2H 2021

    Year Ended December 31, 2020 Financial Highlights

    Cash, cash equivalents, and investments as of December 31, 2020 were approximately $164 million. We currently expect that our cash and cash equivalents will be sufficient to fund our operating expenses and capital requirements into 2024.

    Research and development expenses were $24.6 million for the year ended December 31, 2020, compared to $19.7 million for the year ended December 31, 2019. The increase of $4.9 million was due primarily to increased clinical spending associated with the GALACTIC-1 study.

    General and administrative expenses were $9.0 million for the year ended December 31, 2020, compared to $2.4 million for the year ended December 31, 2019. The increase of $6.6M was primarily related to the October 2020 IPO and other public company costs.

    Net loss attributable to common stockholders for the year ended December 31, 2020 was $34.8 million or $(7.62) per basic and diluted share, compared with $42.1 million, or $(161.82) per basic and diluted share, for the prior year period.

    About Galecto

    Galecto (NASDAQ:GLTO) is a clinical stage biotechnology company incorporated in the U.S. with advanced programs in fibrosis and cancer centered on the development of small-molecule inhibitors of galectin-3 and lysyl oxidase-like 2, or LOXL2, which play key roles in regulating fibrosis. The company's pipeline includes our lead product candidate, which is an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis. Our pipeline also includes two additional assets about to move into phase 2 studies.

    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 our ability to make progress across all our pipeline assets, our plans to initiate three Phase 2 trials, in addition to executing our Phase 2b trial in IPF, GB0139's potential to provide patients with a convenient, effective treatment for IPF, GBO1039's positioning to address an unmet need for a safer and more efficacious treatment option, the potential of our other drug candidates to help patients with serious illnesses, our plans for the GALACTIC-1 trial, including plans for continuing to enroll patients, working with investigators and regulatory authorities, and the timing of completing enrollment, expected upcoming milestones (including the expected timing of data and the completion and initiation of trial enrollment), Galecto's focus and commitment, GB0139's potential, plans for clinical development (including the timing of their initiation) of MYLOX-1, GALLANT-1 and GULLIVER-2 trials and potential to market, Galecto's product candidates and pipeline, and our expectation that our cash and cash equivalents will be sufficient to fund our operating expenses and capital requirements into 2024. 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, their therapeutic potential and outcomes related to our clinical trials, our ability to modify the GALACTIC-1 trial protocol to the satisfaction of the FDA or other regulatory agencies, our ability to continue to enroll patients and complete the GALACTIC-1 trial with fewer dosage groups, the risk that FDA or other regulatory agency imposes a clinical hold on the GALACTIC-1 trial, having adequate funds and their use, and those additional risks and uncertainties disclosed in Galecto's filings with the Securities and Exchange Commission. 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.

    Galecto, Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 


    Investor Relations US


    Investor/Media Relations EU
    Ashley R. Robinson

    arr@lifesciadvisors.com
    Mary-Ann Chang

    mchang@lifesciadvisors.com
    +1 617 775 5956+44 7483 284 853

    Financial Tables to Follow

    GALECTO, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)

     December 31,
     2020 2019
    Cash and cash equivalents$163,582 $11,294
    Receivable on issuance of convertible preferred stock 39,669
    Prepaid expenses and other current assets5,713 5,117
    Operating lease right-of-use assets885 298
    Other assets1,416 231
    Total assets$171,596 $56,609
        
    Current liabilities$5,566 7,927
    Operating lease liabilities, noncurrent541 211
    Total liabilities6,107 8,138
    Total stockholders' equity165,489 48,471
    Total liabilities and stockholders' equity$171,596 $56,609



    GALECTO, INC.


    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share amounts)

     For the Year Ended

    December 30,

     
      2020   2019 
    Operating expenses:     
    Research and development$24,627  $19,738 
    Purchased in-process research and development  $16,788 
    General and administrative9,010  2,445 
    Total operating expenses33,637  38,971 
    Loss from operations(33,637) (38,971)
    Total other income (expense), net(1,200) 2,464 
    Net loss(34,837) (36,507)
    Dividends on convertible preferred stock  (5,560)
    Net loss attributable to common stockholders$(34,837) $(42,067)
    Net loss per common share, basic and diluted$(7.62) $(161.82)
    Weighted-average number of shares used in computing net loss per common share, basic and diluted4,572,702  259,966 
    Other comprehensive loss     
    Net loss(34,837) (36,507)
    Currency translation gain (loss)3,125  (806)
    Total comprehensive loss$(31,712) $(37,313)

     



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  12. BOSTON, March 23, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced it will host an expert perspectives panel on the evolving treatment landscape for idiopathic pulmonary fibrosis (IPF) and the potential for GB0139 on Tuesday, March 30, 2021 at 2pm Eastern Time.

    The webinar will feature a presentation by Key Opinion Leader (KOL) Toby Maher, MD, University of Southern California, who will discuss the current treatment landscape and unmet medical need in treating patients with IPF, as well as the clinical meaning of the exciting biomarker data on GB0139 recently published in the European Respiratory Journal, which showed marked…

    BOSTON, March 23, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced it will host an expert perspectives panel on the evolving treatment landscape for idiopathic pulmonary fibrosis (IPF) and the potential for GB0139 on Tuesday, March 30, 2021 at 2pm Eastern Time.

    The webinar will feature a presentation by Key Opinion Leader (KOL) Toby Maher, MD, University of Southern California, who will discuss the current treatment landscape and unmet medical need in treating patients with IPF, as well as the clinical meaning of the exciting biomarker data on GB0139 recently published in the European Respiratory Journal, which showed marked impact on several IPF biomarkers. GB0139 is Galecto's inhalable, once-daily treatment for IPF, the most advanced treatment in development for IPF, in phase 2b trial with results expected in 2022.

    Galecto Chief Executive Officer Hans Schambye will also give an update on GB0139 following the phase 2b trial modification and be available for questions with Bertil Lindmark, Galecto's Chief Medical Officer, Tariq Sethi, Galecto Co-founder and Professor Emeritus, King's College London, and Dr. Maher following the formal presentations.

    To register for the webinar, please click here. A replay will be archived for 30 days after the webinar.

    Professor Toby Maher is Professor of Clinical Medicine at the Keck School of Medicine at the University of Southern California. Additionally, Prof Maher is British Lung Foundation Chair in Respiratory Research and National Institute for Health Research (NIHR) Clinician Scientist. He is Professor of Interstitial Lung Disease and heads up the Fibrosis Research Group at the National Heart and Lung Institute, Imperial College, London. He is also an honorary Consultant Respiratory Physician on the Interstitial Lung Disease Unit, Royal Brompton Hospital and is Director of the NIHR Respiratory CRF and Director of Respiratory Research at Royal Brompton Hospital.

    His research interests include: biomarker discovery, the lung microbiome and host immune response in the pathogenesis of IPF and clinical trials in interstitial lung disease. He has been involved in >50 trials in fibrotic lung disease from phase 1b through to phase 4 and including those assessing IPF, scleroderma, rheumatoid arthritis and inflammatory myositis. Overall, he has recruited >1000 patients into interventional studies. He has given expert opinion to FDA and EMA.

    He is an associate editor for American Journal of Respiratory and Critical Care Medicine and is on the international advisory board for Lancet Respiratory Medicine. He has authored over 260 papers and book chapters on pulmonary fibrosis.

    About Galecto

    Galecto (NASDAQ:GLTO) is a clinical stage biotechnology company incorporated in the U.S. with advanced programs in fibrosis and cancer centered on the development of small-molecule inhibitors of galectin-3 and lysyl oxidase-like 2, or LOXL2, which play key roles in regulating fibrosis. The company's pipeline includes our lead product candidate, which is an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis. Our pipeline also includes two additional assets about to move into phase 2 studies.

    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 the Phase 2b clinical trial for GB0139, including plans for modification of such trial and the expected date of results, Galecto's focus and commitment, GB0139's potential, plans for clinical development (including the timing of their initiation) and potential to market, and Galecto's product candidates and pipeline. 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, their therapeutic potential and outcomes related to our clinical trials, our ability to modify the GALACTIC-1 trial protocol to the satisfaction of the FDA or other regulatory agencies, our ability to continue to enroll patients and complete the GALACTIC-1 trial with fewer dosage groups, the risk that FDA or other regulatory agency imposes a clinical hold on the GALACTIC-1 trial, having adequate funds and their use, and those additional risks and uncertainties disclosed in Galecto's filings with the Securities and Exchange Commission. 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:

    Galecto, Inc. 
    Hans Schambye, CEO

     
    Jon Freve, CFO 
    +45 70 70 52 10 
      
    Investors/USMedia/EU
    Ashley R. Robinson

    Mary-Ann Chang

    arr@lifesciadvisors.commchang@lifesciadvisors.com
    +1 617 430 7577+44 7483 284 853


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  13. BOSTON, March 15, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that an independent Data Safety Monitoring Board (DSMB) has completed its interim review of the company's Phase 2b GALACTIC-1 study of GB0139 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). On Friday, March 12, the DSMB recommended that, based upon a safety analysis of the data, the company discontinue dosing and enrolling patients in the 10 mg arm along with patients in the 3 mg arm who are receiving combination treatment with the currently approved treatments of IPF, nintedanib and pirfenidone. We expect the 3 mg and placebo arms in patients who are…

    BOSTON, March 15, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that an independent Data Safety Monitoring Board (DSMB) has completed its interim review of the company's Phase 2b GALACTIC-1 study of GB0139 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). On Friday, March 12, the DSMB recommended that, based upon a safety analysis of the data, the company discontinue dosing and enrolling patients in the 10 mg arm along with patients in the 3 mg arm who are receiving combination treatment with the currently approved treatments of IPF, nintedanib and pirfenidone. We expect the 3 mg and placebo arms in patients who are not on concomitant nintedanib or pirfenidone will continue enrolling patients.

    GALACTIC-1 is a 52-week randomized, double-blind, multicenter, parallel, placebo-controlled Phase 2b study being conducted across more than 100 centers globally, investigating the safety and efficacy of Galecto's lead compound, GB0139, in patients with IPF. Initial unblinded data readout is anticipated in 2022.

    The DSMB informed the company, based on unblinded safety and efficacy data, that there was an imbalance in the serious adverse experiences across the study groups, but not an imbalance between the groups in mortality. Galecto expects to continue recruiting patients who are not taking nintedanib or pirfenidone at screening and who would be randomized to receive GB0139 3 mg or placebo. The DSMB recommended the patients randomized to the 10mg group and all those taking nintedanib or pirfenidone should be discontinued from the study. Based on these recommendations, the Company plans to work with both the study investigators and the appropriate regulatory authorities to implement these changes promptly.

    "Galecto is committed to patient safety and continuing the development of life changing treatments for patients with IPF. Around 50% of IPF patients in Europe and the US do not receive treatment with either pirfenidone or nintedanib, representing a very significant unmet medical need, as they have no available treatment options. Based on our prior phase 1b/2a study of GB0139 in IPF patients, we believe the 3 mg dose has the potential to be an effective clinical dose for these patients," said Dr. Hans Schambye, CEO of Galecto. He added "there is a very strong demand for a tolerable alternative to the approved therapies."

    "We do not expect the recommended changes, which relate solely to the inhaled GB0139 in IPF, to impact any of our other planned trials. We continue to look forward to initiating three additional Phase 2 trials this year with our other clinical stage assets GB2064 (oral LOXL2 inhibitor) and GB1211 (oral Galectin-3 inhibitor). We anticipate completing enrollment in the GALACTIC-1 trial this year with initial data readout in 2022," added Dr. Schambye.

    About Galecto

    Galecto (NASDAQ:GLTO) is a clinical stage biotechnology company incorporated in the U.S. with advanced programs in fibrosis and cancer centered on the development of small-molecule inhibitors of galectin-3 and lysyl oxidase-like 2, or LOXL2, which play key roles in regulating fibrosis. The company's pipeline includes our lead product candidate, which is an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis. Our pipeline also includes two additional assets about to move into phase 2 studies.

    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 the GALACTIC-1 trial, including plans for continuing to enroll patients, working with investigators and regulatory authorities, the timing of completing enrollment and the initial unblinded data readout, Galecto's focus and commitment, GB0139's potential (including the effectiveness of the 3 mg dose), plans for clinical development (including the timing of their initiation) and potential to market, and Galecto's product candidates and pipeline. 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, their therapeutic potential and outcomes related to our clinical trials, our ability to modify the GALACTIC-1 trial protocol to the satisfaction of the FDA or other regulatory agencies, our ability to continue to enroll patients and complete the GALACTIC-1 trial with fewer dosage groups, the risk that FDA or other regulatory agency imposes a clinical hold on the GALACTIC-1 trial, having adequate funds and their use, and those additional risks and uncertainties disclosed in Galecto's filings with the Securities and Exchange Commission. 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:

    Galecto Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 
      
    Investors/USMedia/EU
    Ashley R. Robinson

    arr@lifesciadvisors.com

    Mary-Ann Chang

    mchang@lifesciadvisors.com

    +1 617 775 5956+44 7483 284 853



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  14. BOSTON, Feb. 09, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced Hans Schambye, the Company's Chief Executive Officer, will participate in multiple upcoming investor conferences. Dr. Schambye and Jon Freve, the Company's Chief Financial Officer, will be available for 1x1 meetings with investors at all meetings. Details are as follows:

    SVB Leerink 10th Annual Global Healthcare Conference – Presenting on Wednesday, February 24, 2021 at 9:20 AM ET and hosting investor meetings on the same date

    Credit Suisse London Global Healthcare Conference – Hosting investor meetings Tuesday, March 2 through Thursday, March 4, 2021

    BOSTON, Feb. 09, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced Hans Schambye, the Company's Chief Executive Officer, will participate in multiple upcoming investor conferences. Dr. Schambye and Jon Freve, the Company's Chief Financial Officer, will be available for 1x1 meetings with investors at all meetings. Details are as follows:

    SVB Leerink 10th Annual Global Healthcare Conference – Presenting on Wednesday, February 24, 2021 at 9:20 AM ET and hosting investor meetings on the same date

    Credit Suisse London Global Healthcare Conference – Hosting investor meetings Tuesday, March 2 through Thursday, March 4, 2021

    Oppenheimer 31st Annual Healthcare Conference – Presenting on Tuesday, March 16, 2021 at 8:00 AM ET and hosting investor meetings on the same date

    A live webcast of the available presentations will be posted under the Investor section of the Company's website at www.galecto.com. A replay of each available presentation will be available for 30 days following the event.

    About Galecto

    Galecto (NASDAQ:GLTO) is a clinical stage biotechnology company incorporated in the U.S. with advanced programs in fibrosis and cancer centered on the development of small-molecule inhibitors of galectin-3 and lysyl oxidase-like 2, or LOXL2, which play key roles in regulating fibrosis. The Company's pipeline includes our lead product candidate, which is an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis. Our pipeline also includes two additional assets about to move into phase 2 studies.

    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 focus, plans for clinical development, product candidates and pipeline. 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. 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:

    Galecto Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 


    Investors/US


    Media/EU
    Ashley R. Robinson

    arr@lifesciadvisors.com
    Mary-Ann Chang

    mchang@lifesciadvisors.com
    +1 617 775 5956+44 7483 284 853



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  15. BOSTON, Jan. 08, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc., (NASDAQ:GLTO) a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the appointment of Dr. Anne Prener to its Board of Directors.

    "We warmly welcome Anne to our Board. She will be a tremendous asset with her deep experience and exceptional leadership qualities," said Hans Schambye, CEO of Galecto. "Anne brings to our Board a unique perspective after having served as CEO on several companies; she is an accomplished and seasoned executive, and we welcome her guidance."

    Dr. Anne Prener noted, "I am delighted to join this dynamic company's Board of Directors. Galecto has an exciting pipeline of product…

    BOSTON, Jan. 08, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc., (NASDAQ:GLTO) a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the appointment of Dr. Anne Prener to its Board of Directors.

    "We warmly welcome Anne to our Board. She will be a tremendous asset with her deep experience and exceptional leadership qualities," said Hans Schambye, CEO of Galecto. "Anne brings to our Board a unique perspective after having served as CEO on several companies; she is an accomplished and seasoned executive, and we welcome her guidance."

    Dr. Anne Prener noted, "I am delighted to join this dynamic company's Board of Directors. Galecto has an exciting pipeline of product candidates within fibrosis and cancer and a lead candidate in phase 2 for Idiopathic pulmonary fibrosis (IPF). After reviewing the accomplishments and the opportunities that lie ahead, I believe in management's vision and opportunity to make a meaningful difference in the lives of patients suffering from IPF."

    Dr. Anne Prener has more than 25 years of leadership experience within life sciences companies, and currently serves as Chief Executive Officer of Imbria Inc. and as venture partner at SV Health Investors. Dr. Prener previously served as CEO of Freeline Ltd. Dr. Prener has led companies and teams across several therapeutic areas, including a focus on rare diseases. As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform. Prior to joining Freeline, she served as CEO of Gyroscope Therapeutics Ltd., a gene therapy company focused on eye diseases. Before that, Dr. Prener was Global Therapeutic Area Head of Hematology and Vice President, Clinical Research Hematology at Baxalta. During her time there, three new major product approvals in the U.S. and EU were secured along with a significant advancement in Baxalta's hematology portfolio. Earlier in her career, Dr. Prener held several positions of increasing responsibility at Novo Nordisk, most recently serving as Senior Vice President, Hemophilia R&D Portfolio, where she was instrumental in building a portfolio of late stage and commercial hemophilia products. Dr. Prener serves on the Boards of Directors of several life science companies, Rubius Therapeutics, Kaleido Bioscience and Renovacor. Dr. Prener holds a Ph.D. in epidemiology and an M.D., both from the University of Copenhagen.

    About Galecto

    Galecto (NASDAQ:GLTO) is a clinical stage biotechnology company incorporated in the U.S. with advanced programs in fibrosis and cancer centered on the development of small-molecule inhibitors of galectin-3 and lysyl oxidase-like 2, or LOXL2, which play key roles in regulating fibrosis. The company's pipeline includes our lead product candidate, which is an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis. Our pipeline also includes two additional assets about to move into phase 2 studies.

    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 focus, GB0139's potential, plans for clinical development and potential to market, and Galecto's product candidates and pipeline. 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. 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:

    Galecto Inc. 
    Hans Schambye, CEO

     
    Jon Freve, CFO 
    +45 70 70 52 10 
      
    Investors/USMedia/EU
    Ashley R. RobinsonMary-Ann Chang
    arr@lifesciadvisors.com

    mchang@lifesciadvisors.com

    +1 617 775 5956+44 7483 284 853



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  16. BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that Hans Schambye, Chief Executive Officer, will participate in two panel discussions at the LifeSci Partners 10th Annual Healthcare Corporate Access Event, which is being held virtually from January 6-8 and 11-14.

    The first panel, entitled "Separating the Wheat from the Chaff: Most Promising Novel Oncology Targets in Development", takes place on Thursday, January 7, 2021 at 8:00AM Eastern Standard Time. Investors can pre-register for this panel discussion here.

    The second panel, titled "EU Companies IPO-ing in the US: Benefits of…

    BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that Hans Schambye, Chief Executive Officer, will participate in two panel discussions at the LifeSci Partners 10th Annual Healthcare Corporate Access Event, which is being held virtually from January 6-8 and 11-14.

    The first panel, entitled "Separating the Wheat from the Chaff: Most Promising Novel Oncology Targets in Development", takes place on Thursday, January 7, 2021 at 8:00AM Eastern Standard Time. Investors can pre-register for this panel discussion here.

    The second panel, titled "EU Companies IPO-ing in the US: Benefits of EU Companies Listing on NASDAQ", is also on Thursday, January 7, 2021 at 10AM EST. Investors can pre-register for this panel discussion here.

    In addition, investors interested in meeting with our management team to learn more about Galecto and our pipeline can schedule a 1:1 to meet with us here.

    About Galecto

    Galecto is a clinical stage biotechnology company incorporated in the U.S. with advanced programs in fibrosis and cancer centered on galectin-3 and LOXL2. The company's pipeline includes an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis, as well as two additional assets about to move into phase 2.

    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 focus, plans for clinical development, product candidates and pipeline. 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. 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:

    Galecto Inc. 
    Hans Schambye, CEO

    Jon Freve, CFO
     
    +45 70 70 52 10 




    Investors/US




    Media/EU
    Ashley R. Robinson

    arr@lifesciadvisors.com
    Mary-Ann Chang

    mchang@lifesciadvisors.com
    +1 617 775 5956+44 7483 284 853



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  17. Successfully completed listing on US Nasdaq and raised over $150 million during recent IPO and preceding crossover round

    Funds to support preparations for potential EU conditional approval of GB0139 in IPF and multiple new Phase 2 clinical trials

    BOSTON and COPENHAGEN, Denmark, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Galecto, Inc., a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the third quarter ended September 30, 2020 and provided a corporate update.

    Recent Highlights

    • Successfully completed an Initial Public Offering (IPO) with shares beginning trading on the Nasdaq Global Market on October 29, 2020 under the ticker symbol…

    Successfully completed listing on US Nasdaq and raised over $150 million during recent IPO and preceding crossover round

    Funds to support preparations for potential EU conditional approval of GB0139 in IPF and multiple new Phase 2 clinical trials

    BOSTON and COPENHAGEN, Denmark, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Galecto, Inc., a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the third quarter ended September 30, 2020 and provided a corporate update.

    Recent Highlights

    • Successfully completed an Initial Public Offering (IPO) with shares beginning trading on the Nasdaq Global Market on October 29, 2020 under the ticker symbol "GLTO." The Company raised approximately $150 million in total funds during the recent IPO and preceding crossover investment round.



    • Published full results from its Phase 2a study of GB0139 in Idiopathic Pulmonary Fibrosis (IPF) in the peer-reviewed European Respiratory Journal. Data from the trial demonstrated inhaled GB0139 showed major effects on IPF biomarkers, including YKL-40 (which has been linked to IPF mortality) and CCL-18 (which has been linked to a decrease in lung function). These and several other biomarkers (PDGF-B, PAI-1, Galectin-3) were reduced in a dose dependent fashion from baseline in a consistent and statistically significant manner, with the strongest effects in the 10 mg dose group compared to placebo.



    • Presented Phase 1 clinical data at the American Chemical Society (ACS) Fall virtual meeting on GB1211, the Company's potent and selective oral small molecule galectin-3 inhibitor, showing that it is well tolerated.



    • Received Orphan Drug Designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for GB0139 in the treatment of IPF. The EMA cited clinically relevant biomarker data in IPF patients as a justification for the ODD designation, providing financial incentives to encourage the development of drugs to treat rare diseases.



    • Strengthened is Board of Directors with the appointment Jayson Dallas, a seasoned executive with global experience in both the pharmaceutical and biotech industries.

    "We have made tremendous progress both clinically and as a company, and are excited to have successfully completed our IPO in the US," said Hans Schambye, CEO of Galecto. "We are well positioned to execute on all of our strategic goals, and look forward to continue building on our momentum as we advance on our promising GB0139 product candidate and expand our clinical development pipeline with the initiation of three Phase 2 studies for other product candidates."

    Third Quarter 2020 Financial Highlights

    • Cash, cash equivalents, and investments as of September 30, 2020 were $85.3 million. As of November 30, 2020, cash, cash equivalents, and investments were $168.4 million, which includes the net proceeds raised in our recent IPO.



    • Research and Development expenses for the three months ended September 30, 2020 were $7.7 million, compared to $3.7 million for the three months ended September 30, 2019. The increase of $4.0 million was primarily related to an increase in clinical expenses, including an increase in chemistry, manufacturing and control, or CMC, activities, and expenses related to our Phase 2b study of GB0129 and preparations for a Phase 2a study of GB1211.



    • General and administrative expenses were $2.5 million for the three months ended September 30, 2020, compared to $1.2 million for the three months ended September 30, 2019. The increase of $1.3 million was primarily related to an increase in consultant costs, accounting fees, and an increase in personnel costs, partially offset by a decrease in legal fees.



    • Net loss attributable to common stockholders for the three months ended September 30, 2020 was $14.4 million or ($55.25) per basic and diluted share, compared with $5.5 million, or ($21.18) per basic and diluted share, for the prior year period.

    About Galecto

    Galecto is a clinical stage biotechnology company with advanced programs in fibrosis and cancer centered on galectin-3 and LOXL2. The company's pipeline includes an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis, as well as two assets about to move into phase 2 targeting myelofibrosis, NASH and oncology. The Company is incorporated in the U.S. and has its operating headquarters in Copenhagen, Denmark.

    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 focus, GB0139's potential, plans for clinical development and potential to market, and Galecto's product candidates and pipeline. 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, including its Registration Statement on Form S-1. 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:

    Galecto Inc.LifeSci Advisors (media)
    Hans Schambye, CEOMary-Ann Chang
    Jon Freve, CFO

    +45 70 70 52 10
    +44 7483 284853
    info@galecto.com



    mchang@lifesciadvisors.com



    Financial Tables to Follow

    GALECTO, INC.

    Condensed Consolidated Balance Sheets

    (in thousands, except share and per share amounts)

    (Unaudited)

     September 30, December 31,
     2020 2019
    Cash and cash equivalents$85,333 $11,294
    Receivable on issuance of convertible preferred stock5,473 39,669
    Prepaid expenses and other current assets5,337 5,117
    Operating lease right-of-use assets905 298
    Other assets1,106 231
    Total assets$98,154 $56,609
        
    Current liabilities$8,281 $7,927
    Operating lease liabilities, noncurrent589 211
    Total liabilities8,870 8,138
    Total stockholders' equity89,284 48,471
    Total liabilities and stockholders' equity$98,154 $56,609
        

    GALECTO, INC.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share amounts)

    (Unaudited)

     For the Three Months Ended

    September 30,
     For the Nine Months Ended

    September 30,
     2020 2019 2020 2019
    Operating expenses:       
    Research and development$7,651 $3,674 $16,874 $11,893
    General and administrative2,515 1,152 5,461 2,224
    Total operating expenses10,166 4,826 22,335 14,117
    Loss from operations(10,166) (4,826) (22,335) (14,117)
    Total other income (expense), net(1,485) 721 (925) 2,033
    Net loss(11,651) (4,105) (23,260) (12,084)
    Dividends on convertible preferred stock(2,713) (1,401) (7,648) (4,159)
    Net loss attributable to common stockholders$(14,364) $(5,506) $(30,908) $(16,243)
    Net loss per common share, basic and diluted$(55.25) $(21.18) $(118.89) $(62.48)
    Weighted-average number of shares used in computing net loss

    per common share, basic and diluted
    259,966 259,966 259,966 259,966
    Other comprehensive loss       
    Net loss(11,651) (4,105) (23,260) (12,084)
    Currency translation2,331 (2,059) 2,136 (2,140)
    Total comprehensive loss$(9,320) $(6,164) $(21,124) $(14,224)
            

     



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    • The ERJ Paper shows major effects on biomarkers in IPF, linked to mortality and to fall in FVC
    • The inhaled GB0139 significantly reduced key plasma biomarkers from baseline vs placebo over 2 weeks
    • GB0139 is being investigated in the 450 patients, 52 week GALACTIC-1 Phase 2b/3 trial in IPF

    BOSTON and COPENHAGEN, Denmark, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Galecto, Inc., a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, announced today the publication of a paper detailing full results from a phase 2a study of GB0139 in Idiopathic Pulmonary Fibrosis (IPF) in the peer-reviewed publication European Respiratory Journal.

    The study highlights the effect of inhaled GB0139 in IPF patients on the…

    • The ERJ Paper shows major effects on biomarkers in IPF, linked to mortality and to fall in FVC
    • The inhaled GB0139 significantly reduced key plasma biomarkers from baseline vs placebo over 2 weeks
    • GB0139 is being investigated in the 450 patients, 52 week GALACTIC-1 Phase 2b/3 trial in IPF

    BOSTON and COPENHAGEN, Denmark, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Galecto, Inc., a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, announced today the publication of a paper detailing full results from a phase 2a study of GB0139 in Idiopathic Pulmonary Fibrosis (IPF) in the peer-reviewed publication European Respiratory Journal.

    The study highlights the effect of inhaled GB0139 in IPF patients on the plasma levels of highly relevant disease biomarkers, in particular YKL-40 and CCL-18, which have been shown to have prognostic significance in IPF (YKL-40 linked to IPF mortality and CCL-18 linked to fall in lung function – FVC). These and several other biomarkers (PDGF-B, PAI-1, Galectin-3) were reduced in a dose dependent fashion from baseline in a consistent and statistically significant manner, with the strongest effects in the 10 mg dose group compared to placebo.

    Hans Schambye, CEO of Galecto, said: "We are excited that the study showed that with intervention with our inhaled small molecule therapy GB0139 in the lungs of IPF patients, we see fast onset and major reduction in a series of biomarkers known as drivers of lung fibrosis and linked to IPF mortality. GB0139's concerted and marked impact on these biomarkers support its potential to make a significant difference in the treatment of IPF, and we are looking forward to advancing it further through clinical development and potentially to market."

    GB0139, an inhaled small molecule inhibitor of galectin-3, a protein known to play a central role in fibrosis in several organs, has received Orphan Drug Designation (ODD) from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of IPF. The EMA cited clinically relevant biomarker data, in particular the significant reduction of YKL-40 in IPF patients, as a justification for the ODD designation. GB0139 was shown to be safe and well tolerated in healthy subjects and IPF patients in the phase 2a trial, and dose dependently suppressed expression of galectin-3, a protein known to play a central role in fibrosis in several organs, on alveolar macrophages.

    "The availability of multiple biomarkers of IPF pathogenesis means physicians can not only monitor the progression of disease but also differentiate the effects of different treatments. The lockstep reduction in five biomarkers – PDGF-BB, PAI-1, Galectin-3, CCL18 and YKL-40 – in patients treated with TD139, but not with placebo, is an encouraging early sign that will require clinical confirmation," said Toby Maher, one of the authors of the paper and Professor at Royal Brompton Hospital, Imperial College London and University of Southern California.

    Galecto is now investigating GB0139 (formerly TD139) in the Phase 2b/3 GALACTIC-1 clinical trial in IPF. The trial is a pivotal size, randomized, double-blind, multicenter, parallel, placebo-controlled study across more than 100 centers in the U.S., the EU, and Canada, designed to evaluate the efficacy and safety of GB0139 in 450 subjects with IPF over 52 weeks.

    About Galecto

    Galecto is a clinical stage biotechnology company with advanced programs in fibrosis and cancer centered on galectin-3 and LOXL2. The company's pipeline includes an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis, as well as two assets about to move into phase 2 targeting myelofibrosis, NASH and oncology. The Company is incorporated in the U.S. and has its operating headquarters in Copenhagen, Denmark.

    Further information can be found at 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 focus, GB0139's potential, plans for clinical development and potential to market, and Galecto's product candidates and pipeline. 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, including its Registration Statement on Form S-1. 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:

    Galecto Inc.LifeSci Advisors (media)
    Hans Schambye, CEO

    Jon Freve
    Mary-Ann Chang
    +45 70 70 52 10+44 7483 284 853
    info@galecto.com

    mchang@lifesciadvisors.com



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    • Has extensive experience in pharma and biotech in U.S., Europe and globally
    • Galecto completed U.S. initial public offering and plans to initiate three Phase 2 trials in the coming months

    BOSTON and COPENHAGEN, Denmark, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that senior healthcare executive Jayson Dallas has joined its Board of Directors, effective November 19.

    Jayson Dallas has extensive experience in both pharmaceutical and biotech industries in the U.S., Europe and globally, most recently as Chief Executive Officer of the California-based Aimmune Therapeutics, acquired by Nestlé Health Science…

    • Has extensive experience in pharma and biotech in U.S., Europe and globally

    • Galecto completed U.S. initial public offering and plans to initiate three Phase 2 trials in the coming months

    BOSTON and COPENHAGEN, Denmark, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that senior healthcare executive Jayson Dallas has joined its Board of Directors, effective November 19.

    Jayson Dallas has extensive experience in both pharmaceutical and biotech industries in the U.S., Europe and globally, most recently as Chief Executive Officer of the California-based Aimmune Therapeutics, acquired by Nestlé Health Science this year. He is a member of the Board of Directors of Arena Pharmaceuticals and has previously served in senior roles for companies including Pfizer, Novartis, Roche and Ultragenyx Pharmaceuticals. His experience spans multiple therapeutic categories and covers new product launches, licensing and managing product portfolios.

    Hans Schambye, CEO of Galecto, said: "I am delighted to welcome Jayson to the Galecto Board of Directors. His expertise in all aspects of the healthcare industry, from biotech to big pharma and drug development to commercialization, will be an important source of knowledge and guidance for Galecto as we continue through an exciting period of growth. Following our successful initial public offering in the U.S., we are well positioned to continue advancing our promising GB0139 product candidate and expand our clinical development pipeline with the initiation of three Phase 2 studies for other product candidates in the coming months."

    Jayson Dallas said: "It is an honor to join the Board of Directors of Galecto at such an important and dynamic moment in its history. I look forward to leveraging my industry experience to assist as Galecto advances its exciting products through clinical development and potentially to market, in order to address significant unmet medical needs."

    About Galecto

    Galecto is a clinical stage biotechnology company with advanced programs in fibrosis and cancer centered on galectin-3 and LOXL2. The company's pipeline includes an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis, as well as two assets about to move into phase 2 targeting myelofibrosis, NASH and oncology. The company is incorporated in the U.S. and has its operating headquarters in Copenhagen, Denmark. Further information can be found at 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 clinical trial plans, the significance and participation of a new board member, Galecto's growth, and Galecto's products and pipeline. 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, including its Registration Statement on Form S-1. 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:

    Galecto Inc.LifeSci Advisors (media)
    Hans Schambye, CEO

    Mary-Ann Chang
    Jon Freve, CFO 
    +45 70 70 52 10+44 7483 284 853
    info@galecto.com

    mchang@lifesciadvisors.com



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