Liver Cirrhosis, Alcoholic

– A total of 11 scientific abstracts from Mallinckrodt's research for adults with HRS with rapid reduction in kidney function1 provide further insight into the clinical efficacy, safety, and real-world utility of TERLIVAZ treatment for appropriate patients – – Mallinckrodt's presence to include three oral presentations and one AASLD Poster of Distinction – DUBLIN, Nov. 8, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced the presentation of 11 scientific abstracts with findings from the latest clinical and health economics research with TERLIVAZ® (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 during the American Association for the Study of Liver Diseases (AASLD) 2023 Liver Meeting, taking place November 10-14, 2023 in Boston, MA. Continue Reading Video Showcasing Mallinckrodt Presence at AASLD View PDF HRS Infographic Experience the interactive Multichannel News Release here: Included among Mallinckrodt's breadth of data for adults with HRS with rapid reduction in kidney function1 are three oral presentations and one Poster of Distinction detailing research of clinical outcomes with TERLIVAZ2,3,4 and real-world health economics outcomes for TERLIVAZ-treated patients with comorbidities.5 TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.6 HRS involving rapid reduction in kidney function1 is estimated to affect more than 35,000 Americans annually and rates of HRS hospitalizations are increasing.7,8 Please see Limitation of Use and Important Safety Information, including Boxed Warning, below. "It is essential to continue research into the relationship between TERLIVAZ treatment and key factors impacting clinical outcomes, such as concomitant treatments, comorbidities, and real-world care environments, to provide further insights into the continued use of TERLIVAZ for patients with this critical condition," said Khurram Jamil, MD, Vice President, Hepatology, Clinical Development & Critical Care. "We are thrilled to be able to share findings from our 11 scientific presentations at this year's AASLD Liver Meeting with the medical community – a testament to the breadth and depth of Mallinckrodt's commitment to expanding our collective knowledge of HRS to help physicians diagnose and treat HRS patients as early and effectively as possible." Highlights of Mallinckrodt's 11 scientific presentations at the AASLD 2023 Liver Meeting include: Three Oral Presentations: Findings from a pooled analysis of the three largest-ever prospective studies to assess the safety and efficacy of TERLIVAZ in patients with HRS type 1 (HRS-1) in the U.S. and Canada (CONFIRM, REVERSE, and OT-0401) evaluating the impact of mean arterial pressure on HRS reversal from baseline to end of treatment with TERLIVAZ (Abstract #224).2 Health economics outcomes from a decision-analytic model projecting the benefit of TERLIVAZ treatment among patients with alcohol-related cirrhosis and HRS (Abstract #80).5 An analysis of the clinical outcomes associated with concomitant albumin dosing with TERLIVAZ for the treatment of HRS-acute kidney injury (HRS-AKI) (Abstract #211).3 One AASLD Poster of Distinction: Results from a post hoc analysis of the CONFIRM, REVERSE, and OT-0401 trials assessing the relationship between mean arterial pressure and TERLIVAZ in HRS-AKI reversal (Abstract #3052-A).4 Please see a complete list of Mallinckrodt-sponsored abstracts to be presented at the 2023 AASLD Liver Meeting here. Abstracts can also be found on the 2023 AASLD Liver Meeting website. Mallinckrodt will also be present at the meeting with an interactive Medical Affairs booth in the exhibit hall (Location D2825) throughout the duration of the meeting. Data collected in retrospective, pooled, database, or post hoc analyses may have errors or omissions. Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ. INDICATION AND LIMITATION OF USE TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit. IMPORTANT SAFETY INFORMATION WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO2) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%. Contraindications TERLIVAZ is contraindicated: In patients experiencing hypoxia or worsening respiratory symptoms. In patients with ongoing coronary, peripheral, or mesenteric ischemia. Warnings and Precautions Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients. Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments. Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms. Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure. Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed. For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks. Ischemic Events: TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions or cerebrovascular or ischemic disease. Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions. Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm when administered to a pregnant woman. If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus. Adverse Reactions The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea. Please click here to see full Prescribing Information, including Boxed Warning. About Hepatorenal Syndrome (HRS) Hepatorenal syndrome (HRS) involving rapid reduction in kidney function1 is an acute and life-threatening condition that occurs in people with advanced liver disease.6 HRS is classified into two distinct types – a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care and a more chronic type that progresses over weeks to months.6 HRS involving rapid reduction in kidney function1 is estimated to affect more than 35,000 Americans annually and rates of HRS hospitalizations are increasing.7,8 If left untreated, HRS with rapid reduction in kidney function1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.9,10 ABOUT MALLINCKRODT Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit . Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website. CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with regard to TERLIVAZ®, its potential to improve health and treatment outcomes, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the impact of Mallinckrodt's pending Chapter 11 cases; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with TERLIVAZ; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. CONTACT Media Inquiries Green Room Communications 954-816-6003 [email protected] Investor Relations Daniel J. Speciale Senior Vice President, Finance and Chief Financial Officer, Specialty Generics 314-654-3638 [email protected] Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2023 Mallinckrodt. US-2300796 11/23 References 1 TERLIVAZ® (terlipressin) for Injection. Prescribing Information. Mallinckrodt Hospital Products Inc. 2023. 2 Fricker ZP, et al. Improved Mean Arterial Pressure from Baseline to the End of Treatment with Terlipressin is Associated with Hepatorenal Syndrome Reversal: A Pooled Analysis of 3 Phase III Studies. Abstract to be presented in oral presentation at the American Association for the Study of Liver Diseases (AASLD) 2023 The Liver Meeting. November 2023. 3 Wong F, et al. Albumin Dosing with Terlipressin for the Treatment of HRS-AKI: A Double-Edged Sword. Abstract to be presented in oral presentation at the American Association for the Study of Liver Diseases (AASLD) 2023 The Liver Meeting. November 2023. 4 Cullaro G, et al. Understanding the Relationship Between Mean Arterial Pressure and Terlipressin in Hepatorenal Syndrome-Acute Kidney Injury Reversal: A Post Hoc Analysis of the CONFIRM, REVERSE, and OT-0401 Trials. Poster of Distinction to be presented in oral presentation at the American Association for the Study of Liver Diseases (AASLD) 2023 The Liver Meeting. November 2023. 5 Mumtaz K, et al. Decision-Analytic Model to Project the Benefit of Terlipressin Treatment Among Patients with Alcohol-Related Cirrhosis and HRS. Abstract to be presented in oral presentation at the American Association for the Study of Liver Diseases (AASLD) 2023 The Liver Meeting. November 2023. 6 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: . Accessed October 2023. 7 Data on file – Ref-06931. Mallinckrodt Pharmaceuticals. 8 Singh J, Dahiya DS, Kichloo A, Singh G, Khoshbin K, Shaka H. Hepatorenal Syndrome: A Nationwide Trend Analysis from 2008 to 2018. Annals of Med. 2021;53:1. doi.org/10/1080/07853890 9 Flamm, S.L., Brown, K., Wadei, H.M., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in the United States and the Potential of Terlipressin. Liver Transpl. 2021;27:1191-1202. . 10 Boyer TD, et al. Terlipressin Plus Albumin Is More Effective Than Albumin Alone in Improving Renal Function in Patients With Cirrhosis and Hepatorenal Syndrome Type 1. Gastroenterology. 2016;150:1579-1589. SOURCE Mallinckrodt plc

BOSTON, July 31, 2023 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company and world leader in galectin biology focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the quarter ended June 30, 2023. “Galecto has made strong clinical progress in the first half of the year, setting the stage for several important milestones during the rest of 2023. We completed dosing in our Phase 2b GALACTIC-1 trial of GB0139 in idiopathic pulmonary fibrosis in May and topline results are expected in August. In our oral galectin-3 program, GB1211, we are pleased to have completed dose-range finding in our Phase 1b/2a GALLANT-1 study in non-small cell lung cancer (NSCLC) patients. This allowed us to identify the GB1211 100 mg dose of this promising compound to be examined in combination with checkpoint inhibitors in future oncology trials,” said Hans Schambye, President and Chief Executive Officer of Galecto. “We are also looking forward to later this year reporting topline results from the Phase 2a MYLOX-1 trial of GB2064 and potential initiation of the Phase 2 NIH-sponsored and investigator-initiated GB1211 oncology trial.” Second Quarter and Other Recent Highlights Announced completion of dosing in the Company’s 52-week Phase 2b GALACTIC-1 study of GB0139 for the treatment of idiopathic pulmonary fibrosis (IPF). GB0139 is an investigational inhaled small molecule inhibitor of galectin-3 that is administered as a once-daily inhalation via a generic dry powder inhaler. GB0139 is designed to specifically target galectin-3, a main regulator of the fibrosis cascade. The overexpression of galectin-3 is ubiquitous in fibrotic tissue, including fibrotic lung tissue, and is linked to both disease severity and disease progression, as well as acute exacerbations of IPF. The Company expects to announce topline data from the GALACTIC-1 trial in August 2023, which will represent the third data readout from Galecto’s anti-fibrotic clinical pipeline in the last year.Completed Part A of the Phase 2a GALLANT-1 trial evaluating GB1211 in combination with atezolizumab for the treatment of non-small cell lung cancer (NSCLC). The GALLANT-1 trial is an open-label study to select the dose of GB1211, Galecto’s selective oral small molecule inhibitor of galectin-3, to be used in future trials to evaluate the safety and tumor shrinkage of the combination of GB1211 and checkpoint inhibitors. In connection with completing Part A of the GALLANT-1 trial we conducted an interim safety analysis from Part A of the trial where GB1211 exhibited a favorable safety and tolerability profile. The Safety Review Committee for the trial reviewed the results from Part A and recommended that we continue at the 100 mg twice daily dose of GB1211 in Part B and in combination with checkpoint inhibitors in future trials. Concluded FDA Type C meeting focused on the continued development of GB1211 for the treatment of compensated and decompensated cirrhosis due to non-alcoholic steatohepatitis (NASH) or alcohol-associated cirrhosis. As a result of this recent FDA Type C meeting, Galecto is planning a Phase 2 trial in patients with decompensated NASH cirrhosis. This trial is expected to be initiated in early 2024, subject to obtaining additional financing or collaborating with a third party.Presented a poster at the ATS 2023 International Conference in May highlighting new data on GB0139 in IPF patient-derived lung samples. The poster, entitled: “The Anti-Fibrotic Effect of GB0139, a Small Molecule Galectin-3 Inhibitor, in Precision Cut Lung Slices from Idiopathic Pulmonary Fibrosis Tissue,” showed GB0139 effected a concentration-dependent reduction in markers of fibrosis in comparison to currently approved IPF therapies, perfinidone and nintedanib. Expected Upcoming Milestones Topline results from Phase 2b GALACTIC-1 trial (IPF) with GB0139 in August 2023Topline results from Phase 2a MYLOX-1 trial (myelofibrosis) with GB2064 in 2H 2023Initiation of Phase 2 investigator-sponsored GB1211 oncology trial (melanoma and HNSCC) by Providence Cancer Institute in 2H 2023 Second Quarter 2023 Financial HighlightsCash, cash equivalents, and investments as of June 30, 2023 were approximately $52.1 million. The company anticipates that its cash, cash equivalents and investments will be sufficient to fund operating expenses and capital requirements into the second half of 2024. Research and development expenses were $8.1 million for the period ended June 30, 2023, compared to $13.7 million for the period ended June 30, 2022. The decrease of $5.6 million was due primarily to lower clinical spending based on timing of clinical trial activities. General and administrative expenses were $3.1 million for the period ended June 30, 2023, compared to $3.4 million for the period ended June 30, 2022. The decrease of $0.3 million was primarily related to decreased insurance costs and other various general and administrative costs. Net loss attributable to common stockholders for the period ended June 30, 2023 was $10.7 million or $(0.41) per basic and diluted share, compared with $16.9 million, or $(0.67) per basic and diluted share, for the prior year period. About GalectoGalecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 and LOXL2. Galecto has multiple ongoing Phase 2 clinical programs in fibrosis and cancer, including (i) an inhaled galectin-3 modulator (GB0139) in a Phase 2b trial for the treatment of idiopathic pulmonary fibrosis (IPF); (ii) an orally active LOXL2 inhibitor (GB2064) in a Phase 2a trial for the treatment of myelofibrosis; (iii) an orally active galectin-3 inhibitor (GB1211) in a recently completed Phase 1b/2a trial in liver cirrhosis; and (iv) an orally active galectin-3 inhibitor (GB1211) in combination with atezolizumab (Tecentriq®) in a separate Phase 2a trial for the treatment of NSCLC. 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 ability to make progress across its clinical pipeline of assets, Galecto’s anticipated timelines for its clinical trials investigating GB0139, GB1211 and GB2064, and Galecto’s expectation that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital requirements into the second half 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 and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, Galecto’s Annual Report on Form 10-K, as filed with the SEC on March 9, 2023. 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. RobinsonSandya von der Weidarr@lifesciadvisors.comsvonderweid@lifesciadvisors.com+1 617 430 7577+41 78 680 0538 Financial Tables to Follow GALECTO, INC.Condensed Consolidated Balance Sheets(in thousands) June 30, December 31, 2023 2022 (unaudited) Cash and cash equivalents$22,956 $32,786Marketable securities 29,168 27,438Prepaid expenses and other current assets 3,238 3,686Marketable securities, noncurrent 0 5,832Operating lease right-of-use assets 633 810Other assets, noncurrent 2,808 2,636Total assets$58,803 $73,188 Current liabilities$14,897 $11,107Operating lease liabilities, noncurrent 206 328Total liabilities 15,103 11,435Total stockholders’ equity 43,700 61,753Total liabilities and stockholders' equity$58,803 $73,188 GALECTO, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)(unaudited) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022Operating expenses: Research and development$8,089 $13,707 $18,451 $26,942 General and administrative 3,070 3,414 6,200 7,118 Total operating expenses 11,159 17,121 24,651 34,060 Loss from operations (11,159) (17,121) (24,651) (34,060)Total other income, net 415 234 913 235 Net loss$(10,744) $(16,887) $(23,738) $(33,825)Net loss per common share, basic and diluted$(0.41) $(0.67) $(0.91) $(1.34)Weighted-average number of shares used in computing net loss per common share, basic and diluted 26,375,076 25,270,314 26,025,929 25,266,096 Other comprehensive gain (loss), net of tax (10) (804) 107 (1,179)Total comprehensive loss$(10,754) $(17,691) $(23,631) $(35,004)

BOSTON, July 31, 2023 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company and world leader in galectin biology focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the quarter ended June 30, 2023. “Galecto has made strong clinical progress in the first half of the year, setting the stage for several important milestones during the rest of 2023. We completed dosing in our Phase 2b GALACTIC-1 trial of GB0139 in idiopathic pulmonary fibrosis in May and topline results are expected in August. In our oral galectin-3 program, GB1211, we are pleased to have completed dose-range finding in our Phase 1b/2a GALLANT-1 study in non-small cell lung cancer (NSCLC) patients. This allowed us to identify the GB1211 100 mg dose of this promising compound to be examined in combination with checkpoint inhibitors in future oncology trials,” said Hans Schambye, President and Chief Executive Officer of Galecto. “We are also looking forward to later this year reporting topline results from the Phase 2a MYLOX-1 trial of GB2064 and potential initiation of the Phase 2 NIH-sponsored and investigator-initiated GB1211 oncology trial.” Second Quarter and Other Recent Highlights Announced completion of dosing in the Company’s 52-week Phase 2b GALACTIC-1 study of GB0139 for the treatment of idiopathic pulmonary fibrosis (IPF). GB0139 is an investigational inhaled small molecule inhibitor of galectin-3 that is administered as a once-daily inhalation via a generic dry powder inhaler. GB0139 is designed to specifically target galectin-3, a main regulator of the fibrosis cascade. The overexpression of galectin-3 is ubiquitous in fibrotic tissue, including fibrotic lung tissue, and is linked to both disease severity and disease progression, as well as acute exacerbations of IPF. The Company expects to announce topline data from the GALACTIC-1 trial in August 2023, which will represent the third data readout from Galecto’s anti-fibrotic clinical pipeline in the last year. Completed Part A of the Phase 2a GALLANT-1 trial evaluating GB1211 in combination with atezolizumab for the treatment of non-small cell lung cancer (NSCLC). The GALLANT-1 trial is an open-label study to select the dose of GB1211, Galecto’s selective oral small molecule inhibitor of galectin-3, to be used in future trials to evaluate the safety and tumor shrinkage of the combination of GB1211 and checkpoint inhibitors. In connection with completing Part A of the GALLANT-1 trial we conducted an interim safety analysis from Part A of the trial where GB1211 exhibited a favorable safety and tolerability profile. The Safety Review Committee for the trial reviewed the results from Part A and recommended that we continue at the 100 mg twice daily dose of GB1211 in Part B and in combination with checkpoint inhibitors in future trials. Concluded FDA Type C meeting focused on the continued development of GB1211 for the treatment of compensated and decompensated cirrhosis due to non-alcoholic steatohepatitis (NASH) or alcohol-associated cirrhosis. As a result of this recent FDA Type C meeting, Galecto is planning a Phase 2 trial in patients with decompensated NASH cirrhosis. This trial is expected to be initiated in early 2024, subject to obtaining additional financing or collaborating with a third party. Presented a poster at the ATS 2023 International Conference in May highlighting new data on GB0139 in IPF patient-derived lung samples. The poster, entitled: “The Anti-Fibrotic Effect of GB0139, a Small Molecule Galectin-3 Inhibitor, in Precision Cut Lung Slices from Idiopathic Pulmonary Fibrosis Tissue,” showed GB0139 effected a concentration-dependent reduction in markers of fibrosis in comparison to currently approved IPF therapies, perfinidone and nintedanib. Expected Upcoming Milestones Topline results from Phase 2b GALACTIC-1 trial (IPF) with GB0139 in August 2023 Topline results from Phase 2a MYLOX-1 trial (myelofibrosis) with GB2064 in 2H 2023 Initiation of Phase 2 investigator-sponsored GB1211 oncology trial (melanoma and HNSCC) by Providence Cancer Institute in 2H 2023 Second Quarter 2023 Financial Highlights Cash, cash equivalents, and investments as of June 30, 2023 were approximately $52.1 million. The company anticipates that its cash, cash equivalents and investments will be sufficient to fund operating expenses and capital requirements into the second half of 2024. Research and development expenses were $8.1 million for the period ended June 30, 2023, compared to $13.7 million for the period ended June 30, 2022. The decrease of $5.6 million was due primarily to lower clinical spending based on timing of clinical trial activities. General and administrative expenses were $3.1 million for the period ended June 30, 2023, compared to $3.4 million for the period ended June 30, 2022. The decrease of $0.3 million was primarily related to decreased insurance costs and other various general and administrative costs. Net loss attributable to common stockholders for the period ended June 30, 2023 was $10.7 million or $(0.41) per basic and diluted share, compared with $16.9 million, or $(0.67) per basic and diluted share, for the prior year period. About Galecto Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 and LOXL2. Galecto has multiple ongoing Phase 2 clinical programs in fibrosis and cancer, including (i) an inhaled galectin-3 modulator (GB0139) in a Phase 2b trial for the treatment of idiopathic pulmonary fibrosis (IPF); (ii) an orally active LOXL2 inhibitor (GB2064) in a Phase 2a trial for the treatment of myelofibrosis; (iii) an orally active galectin-3 inhibitor (GB1211) in a recently completed Phase 1b/2a trial in liver cirrhosis; and (iv) an orally active galectin-3 inhibitor (GB1211) in combination with atezolizumab (Tecentriq®) in a separate Phase 2a trial for the treatment of NSCLC. Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit . 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 ability to make progress across its clinical pipeline of assets, Galecto’s anticipated timelines for its clinical trials investigating GB0139, GB1211 and GB2064, and Galecto’s expectation that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital requirements into the second half 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 and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, Galecto’s Annual Report on Form 10-K, as filed with the SEC on March 9, 2023. 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 Sandya von der Weid arr@lifesciadvisors.com svonderweid@lifesciadvisors.com +1 617 430 7577 +41 78 680 0538 Financial Tables to Follow GALECTO, INC. Condensed Consolidated Balance Sheets (in thousands) June 30, December 31, 2023 2022 (unaudited) Cash and cash equivalents $ 22,956 $ 32,786 Marketable securities 29,168 27,438 Prepaid expenses and other current assets 3,238 3,686 Marketable securities, noncurrent 0 5,832 Operating lease right-of-use assets 633 810 Other assets, noncurrent 2,808 2,636 Total assets $ 58,803 $ 73,188 Current liabilities $ 14,897 $ 11,107 Operating lease liabilities, noncurrent 206 328 Total liabilities 15,103 11,435 Total stockholders’ equity 43,700 61,753 Total liabilities and stockholders' equity $ 58,803 $ 73,188 GALECTO, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Operating expenses: Research and development $ 8,089 $ 13,707 $ 18,451 $ 26,942 General and administrative 3,070 3,414 6,200 7,118 Total operating expenses 11,159 17,121 24,651 34,060 Loss from operations (11,159 ) (17,121 ) (24,651 ) (34,060 ) Total other income, net 415 234 913 235 Net loss $ (10,744 ) $ (16,887 ) $ (23,738 ) $ (33,825 ) Net loss per common share, basic and diluted $ (0.41 ) $ (0.67 ) $ (0.91 ) $ (1.34 ) Weighted-average number of shares used in computing net loss per common share, basic and diluted 26,375,076 25,270,314 26,025,929 25,266,096 Other comprehensive gain (loss), net of tax (10 ) (804 ) 107 (1,179 ) Total comprehensive loss $ (10,754 ) $ (17,691 ) $ (23,631 ) $ (35,004 )