GLTO Galecto Inc.

4.81
-0.05  -1%
Previous Close 4.86
Open 4.86
52 Week Low 4.73
52 Week High 17.99
Market Cap $121,509,412
Shares 25,261,832
Float 19,593,903
Enterprise Value $13,397,503
Volume 53,825
Av. Daily Volume 50,771
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Upcoming Catalysts

Drug Stage Catalyst Date
GB0139
COVID-19
Phase 2
Phase 2
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GB0139
Idiopathic pulmonary fibrosis (IPF)
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
GB2064 (MYLOX-1)
Myelofibrosis
Phase 2
Phase 2
Phase 2 trial to be initiated 1H 2021.
GB1211 (GALLANT-1)
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Phase 2 trial to be initiated 2H 2021.
GB1211 (GULLIVER-2)
Liver cirrhosis
Phase 2a
Phase 2a
Phase 2a trial to be initiated 2H 2021

Latest News

  1. 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

    Mary-Ann Chang

    +1 617 775 5956+44 7483 284 853



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  2. 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

    Mary-Ann Chang

    +1 617 430 7577+44 7483 284 853



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  3. 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

    Mary-Ann Chang

    +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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  4. 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

    Mary-Ann Chang

    +1 617 775 5956+44 7483 284 853

     



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  5. 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

    Mary-Ann Chang

    +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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