GLTO

GLTO US Stock
$5.25
Open: $4.57 High: $5.35 Low: $4.57 Close: $5.243
Range: 2021-06-23 - 2021-06-24
Volume: 5,056,416
Market: Open
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  • Galecto's GB0139 Shows Favorable Safety In COVID-19 Patients, But Plans To Focus On Fibrosis, Cancer Programs

    Amid the continued evolution of the COVID-19 landscape, Galecto Inc (NASDAQ: GLTO) said it would focus on the Phase 2 pipeline of fibrosis and cancer treatments, despite announcing positive preliminary topline results from an investigator-initiated trial examining GB0139 in COVID-19. The trial included 41 hospitalized patients who did not require mechanical ventilation, of which 20 were randomized to the GB0139 arm. GB0139 showed a favorable safety profile with no treatment-related serious adver

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  • Galecto’s GB0139 Shows Favorable Safety and Tolerability Profile with Promising Changes in Efficacy Markers in Hospitalized COVID-19 Patients

    GB0139 significantly reduced oxygen flow requirements and improved several biomarkers for lung and systemic inflammation, liver function, tissue damage and coagulationData demonstrate potential of GB0139 in patients with viral-induced acute lung injuryCurrently 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 f

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  • Orphazyme stock's rocket ride leads to 20 volatility halts, Galecto stock halted 7 times

    Shares of Orphazyme A/S blasted 383.8% higher, enough to make the Denmark-based biopharmaceutical company's stock by far the biggest gainer listed on major U.S. exchanges, prior to a trading halt. The stock, which was up as much as 1,387% at its intraday high of $77.77, was halted for volatility for the 20th time Thursday at 3:24 p.m. Eastern with the last trade at $25.30, and remains halted. The stock's rally gave the company a market capitalization of $884.3 million. The company confirmed that

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  • Galecto Hosting Expert Perspectives Webinar on the Current Myelofibrosis Treatment Landscape and Potential Future Treatments

    Webinar on Wednesday, June 9th @ 8amETBOSTON, 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.

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  • Galecto Appoints Garrett Winslow as General Counsel

    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 GalectoGalecto 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 StatementsCertain 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, CEOJon Freve, CFO +45 70 70 52 10 Investors/USMedia/EUAshley R. Robinsonarr@lifesciadvisors.comMary-Ann Changmchang@lifesciadvisors.com+1 617 775 5956+44 7483 284 853

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  • Galecto to Present at Upcoming Investor Conferences and Host Myelofibrosis Key Opinion Leader Event

    Myelofibrosis KOL event to be held on Wednesday, June 9, 2021 at 8:00am ETBOSTON, 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 ConferencesHans 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 EventOn 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 GalectoGalecto 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 StatementsCertain 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, CEOJon Freve, CFO +45 70 70 52 10 Investor Relations USInvestor/Media Relations EUAshley R. Robinsonarr@lifesciadvisors.comMary-Ann Changmchang@lifesciadvisors.com+1 617 430 7577+44 7483 284 853

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  • Galecto Reports First Quarter Financial Results and Provides a Corporate Update

    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 2021Completion of enrollment in GALACTIC-1 Phase 2b clinical trial in IPF patients in 2H 2021Initiation of enrollment in three Phase 2 trials: MYLOX-1 trial (myelofibrosis) in 1H 2021GALLANT-1 trial (NSCLC) in 2H 2021GULLIVER-2 trial (liver cirrhosis) in 2H 2021 Three Months Ended March 31, 2021 Financial HighlightsCash, 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 GalectoGalecto 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 StatementsCertain 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, CEOJon Freve, CFO +45 70 70 52 10 Investor Relations USInvestor/Media Relations EUAshley R. Robinsonarr@lifesciadvisors.comMary-Ann Changmchang@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 $163,582Marketable securities 36,081 —Prepaid expenses and other current assets 6,568 5,713Marketable securities, long-term 38,576 —Operating lease right-of-use assets 933 885Other assets 2,244 1,416Total assets$158,655 $171,596 Current liabilities$5,540 $5,566Operating lease liabilities, noncurrent 544 541Total liabilities 6,084 6,107Total stockholders’ equity 152,571 165,489Total 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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  • Do Institutions Own Galecto, Inc. (NASDAQ:GLTO) Shares?

    The big shareholder groups in Galecto, Inc. ( NASDAQ:GLTO ) have power over the company. Institutions will often hold...

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  • Galecto (GLTO) Enters Oversold Territory

    Galecto (GLTO) has been on a bit of a cold streak lately, but there might be light at the end of the tunnel for this overlooked stock

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  • Galectin-3 has a key role in Gastric Cancer

    Galecto Announces Publication of Paper in the Gastric Cancer JournalBOSTON, 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 GalectoGalecto 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 GB1211Galecto 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-3Galectin-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 StatementsCertain 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, CEOJon Freve, CFO +45 70 70 52 10 Investors/USMedia/EUAshley R. Robinsonarr@lifesciadvisors.comMary-Ann Changmchang@lifesciadvisors.com+1 617 775 5956+44 7483 284 853

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  • Galecto Reports Financial Results for the Year Ended December 31, 2020 and Provides a Corporate Update

    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 2021Completion of enrollment in GALACTIC-1 Phase 2b clinical trial in IPF patients in 2H 2021Initiation of enrollment in three Phase 2 trials: MYLOX-1 trial (myelofibrosis) in 1H 2021GALLANT-1 trial (NSCLC) in 2H 2021GULLIVER-2 trial (liver cirrhosis) in 2H 2021 Year Ended December 31, 2020 Financial HighlightsCash, 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 GalectoGalecto (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 StatementsCertain 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, CEOJon Freve, CFO +45 70 70 52 10 Investor Relations USInvestor/Media Relations EUAshley R. Robinsonarr@lifesciadvisors.comMary-Ann Changmchang@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 2019Cash and cash equivalents$163,582 $11,294Receivable on issuance of convertible preferred stock— 39,669Prepaid expenses and other current assets5,713 5,117Operating lease right-of-use assets885 298Other assets1,416 231Total assets$171,596 $56,609 Current liabilities$5,566 7,927Operating lease liabilities, noncurrent541 211Total liabilities6,107 8,138Total stockholders’ equity165,489 48,471Total 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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  • UPDATE: Galecto Hosting Expert Perspective Panel on the Evolving Treatment Landscape for Idiopathic Pulmonary Fibrosis and Potential for GB0139

    Tuesday, March 30, 2021 @ 2pm Eastern TimeBOSTON, 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 GalectoGalecto (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 StatementsCertain 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, CEOJon Freve, CFO +45 70 70 52 10 Investors/USMedia/EUAshley R. Robinsonarr@lifesciadvisors.comMary-Ann Changmchang@lifesciadvisors.com+1 617 430 7577+44 7483 284 853

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  • Galecto Hosting Expert Perspective Panel on the Evolving Treatment Landscape for Idiopathic Pulmonary Fibrosis and Potential for GB0139

    Tuesday, March 30, 2021 @ 2pm Eastern Time.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 GalectoGalecto (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 StatementsCertain 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/EUAshley R. RobinsonMary-Ann Changarr@lifesciadvisors.commchang@lifesciadvisors.com+1 617 430 7577+44 7483 284 853

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  • Galecto Announces Outcome of Data Safety Monitoring Board Interim Review of Phase 2b GALACTIC-1 Study of GB0139 for Idiopathic Pulmonary Fibrosis: DSMB Recommends Study to Continue with Modifications

    Galecto expects to continue dosing patients in the 3 mg arm, whereas the 10 mg arm and combinations with nintedanib or pirfenidone will be discontinued at the recommendation of the DSMBBOSTON, 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 GalectoGalecto (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 StatementsCertain 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, CEOJon Freve, CFO +45 70 70 52 10 Investors/USMedia/EUAshley R. Robinsonarr@lifesciadvisors.comMary-Ann Changmchang@lifesciadvisors.com+1 617 775 5956+44 7483 284 853

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  • Galecto to Present at Upcoming Investor Conferences

    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 GalectoGalecto (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 StatementsCertain 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, CEOJon Freve, CFO +45 70 70 52 10 Investors/USMedia/EUAshley R. Robinsonarr@lifesciadvisors.comMary-Ann Changmchang@lifesciadvisors.com+1 617 775 5956+44 7483 284 853

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  • We Think Galecto (NASDAQ:GLTO) Can Afford To Drive Business Growth

    There's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...

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  • Galecto Appoints Anne Prener to its Board of Directors

    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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  • Galecto to Take Part in Two Panel Discussions at the LifeSci Partners 10th Annual Healthcare Corporate Access Event

    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.comMary-Ann Chang mchang@lifesciadvisors.com +1 617 775 5956+44 7483 284 853

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  • Galecto Reports Third Quarter 2020 Operating & Financial Results and Provides a Corporate Update

    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 trialsBOSTON 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) $(62.48) Weighted-average number of shares used in computing net loss per common share, basic and diluted259,966 259,966 259,966 259,966 Other comprehensive loss        Net loss(11,651) (4,105) (23,260) (12,084) Currency translation2,331 (2,059) 2,136 (2,140) Total comprehensive loss$(9,320) $(6,164) $(21,124) $(14,224)

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  • Galecto Publishes GB0139 Phase 2a Idiopathic Pulmonary Fibrosis (IPF) Results in European Respiratory Journal, Showing Marked Impact on Several IPF Biomarkers

    * 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 StatementsCertain 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 FreveMary-Ann Chang +45 70 70 52 10+44 7483 284 853 info@galecto.com mchang@lifesciadvisors.com

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