GLTO Galecto Inc.

3.38
-0.13  -4%
Previous Close 3.51
Open 3.5
52 Week Low 3.34
52 Week High 17.99
Market Cap $85,417,833
Shares 25,261,832
Float 19,593,903
Enterprise Value $-11,046,497
Volume 90,307
Av. Daily Volume 124,538
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
GB1211 (GULLIVER-2)
Liver cirrhosis
Phase 2a
Phase 2a
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
GB0139 (GALACTIC-1)
Idiopathic pulmonary fibrosis (IPF)
Phase 2b
Phase 2b
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
GB2064 (MYLOX-1)
Myelofibrosis
Phase 2
Phase 2
Phase 2 trial initiation of dosing announced August 18, 2021.
GB1211 (GALLANT-1)
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Phase 2 trial to be initiated 2Q 2022.
GB0139
COVID-19
Phase 2
Phase 2
Phase 2 top-line data released June 22, 2021. Will focus resources on other pipeline treatments.

Latest News

  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

     

     



    Primary Logo

    View Full Article Hide Full Article
  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





    Primary Logo

    View Full Article Hide Full Article
  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



    Primary Logo

    View Full Article Hide Full Article
  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)


    Primary Logo

    View Full Article Hide Full Article
  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



    Primary Logo

    View Full Article Hide Full Article
View All Galecto Inc. News