GB-1211

Partial response seen in three of five patients with advanced non-small cell lung cancer who received GB1211 100 mg plus atezolizumab for at least three weeksBOSTON, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today presented a poster with new and encouraging clinical data, including two additional partial responders, from the dose-finding Part A of its Phase 1b/2a trial (NCT05240131) (the GALLANT-1 trial) at the European Society of Medical Oncology (ESMO) Congress 2023 in Madrid, Spain. The GALLANT-1 trial is designed to study the combination of atezolizumab (Tecentriq®) and GB1211, Galecto’s first-in-class, oral small-molecule galectin-3 inhibitor candidate, in the first-line treatment of patients with metastatic/advanced non-small cell lung cancer (NSCLC). At the recommended Phase 2 dose level of 100 mg GB1211 twice daily, investigator-assessed objective tumor responses (defined as partial responses per RECIST criteria 1.1) were observed in three of five patients (60%) who received GB1211 for at least three weeks. Response rates of only 22–38% have been observed with atezolizumab monotherapy in the first-line treatment of advanced NSCLC, suggesting a potential benefit of adding GB1211 to atezolizumab. The Company believes that GALLANT-1 is the first clinical trial to show that combining an oral galectin-3 inhibitor with a checkpoint inhibitor may enhance the effect of checkpoint inhibitors. In addition, insights from early biomarker analyses revealed a trend showing that responders had increased levels of galectin-3 at baseline, and stable or decreasing galectin-3 levels during treatment. In contrast, patients with progressive disease demonstrated increasing levels of galectin-3 during treatment. This correlation suggests that the detection of galectin-3 levels could potentially be used to select and monitor patient populations. Overall, the combination of GB1211 100 mg and atezolizumab appeared to be well-tolerated, with predominantly Grade 1 and Grade 2 treatment emergent adverse effects observed. At the 200 mg twice daily dose-level, two severe dose-limiting skin reactions were observed that may indicate lymphocyte activation in line with the GB1211 mode of action, which resulted in a reduction to the 100 mg GB1211 dose level. Importantly, these skin rashes were not observed at the recommended Phase 2 dose level of 100 mg GB1211 twice daily. As part of Galecto’s recently announced strategic alternative process, Galecto has determined that it will not initiate Part B of the GALLANT-1 trial and will instead reallocate its resources to focus on the treatment of severe liver diseases. Galecto will continue to supply GB1211 100 mg for the upcoming investigator-initiated Phase 2 trial at Providence Portland Medical Center’s Earle A. Chiles Research Institute (EACRI). This trial, which is expected to be initiated in early 2024, will evaluate the safety and efficacy of GB1211 in combination with pembrolizumab (Keytruda®). Galecto plans to explore external options for partnering and/or funding additional oncology-focused activities for GB1211 as part of its strategic alternative process. Following the poster presentation at the ESMO Congress, the poster will be available on the Scientific Conferences page of Galecto’s investor relations website at https://ir.galecto.com/news-and-events/scientific-events. About GB1211 and Galectin-3 Mechanisms in CancerIncreased galectin-3 expression in tumors is linked to tumor growth, invasiveness and metastatic potential. In the tumor tissue, galectin-3 supports the creation of fibrosis, tumor proliferation, metastasis, and immune avoidance. Galectin-3 uses a host of mechanisms to increase tumor growth and metastasis. Furthermore, increased levels of galectin-3 in the tumor microenvironment facilitates tumor escape from the immune response by suppressing essential T-cell functions and activating tumor-protecting macrophages. Evidence suggests that galectin-3 can enhance PD-1 and PD-L1 binding and avert the interference of anti-PD-1/anti-PD-L1 therapies by blocking the binding of the antibodies to their respective targets. GB1211 is designed to counter these effects. About the GALLANT-1 trialThe Phase 1b/2a trial of GB1211 in combination with atezolizumab (Tecentriq®) was designed to be a randomized, double-blind, placebo-controlled trial in patients with NSCLC in the first-line setting. Part A of the GALLANT-1 trial was an open-label trial that determined the 100 mg dose of GB1211 to be the recommended dose in future oncology trials. Part B of the GALLANT-1 trial had been designed to evaluate safety and tumor shrinkage in NSCLC patients and explore tumor response rate based on RECIST criteria (version 1.1), clinical activity, and immune biomarkers. 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 Phase 2 clinical programs in fibrosis and cancer, including (i) an orally active LOXL2 inhibitor (GB2064) in a Phase 2a trial for the treatment of myelofibrosis; (ii) an orally active galectin-3 inhibitor (GB1211) in a recently completed Phase 1b/2a trial in liver cirrhosis; and (iii) 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 the potential safety and efficacy of GB1211; the timing of initiating clinical trials not being conducted by Galecto; and Galecto’s focus and plans for clinical development of its product candidates and pipeline. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto’s product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto’s filings with the Securities and Exchange Commission (SEC), including, 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

Galecto made no mention of whether its remaining clinical programs would be affected by the workforce restructuring or search for strategic alternatives. A month after halting work on an inhaled treatment for idiopathic pulmonary fibrosis in the wake of a phase 2 trial fail, Galecto is laying off 70% of its workforce as the Boston-based biotech mulls its options. The company has just completed a review of its business and is now conducting a “comprehensive exploration of strategic alternatives focused on maximizing shareholder value.” As is usual for biotechs in dire straits, the potential options include an acquisition, merger or yard sale of the company’s assets. Galecto made the usual caveat that it couldn’t guarantee that any transaction “will be completed on attractive terms, if at all.” But one thing that is for certain is that 29 employees—equivalent to 70% of the company’s entire workforce—will be heading out the door. The writing may have been on the wall for the biotech back in August, when Galecto announced that its small-molecule inhibitor of galectin-3, dubbed GB0139, failed to hit the trial’s primary endpoint of a demonstrating a slowing in decline in the volume of air exhaled from the lungs of patients with idiopathic pulmonary fibrosis. In fact, the average reduction in forced vital capacity was 316.6 ml among patients treated with a 3-mg daily dose of GB0139 for a year, compared to a less pronounced drop of 127.5 ml for those given placebo, meaning treated patients fared much worse. The drug had a bumpy ride to even get to this stage, with a data safety and monitoring board recommending in March 2021 that the company ax the 10-mg treatment arm after an “imbalance” in serious side effects was cropping up. With the 3-mg dose also coming up short last month, the biotech turned its attention to another galectin-3 inhibitor called GB1211, which is in development for liver cirrhosis. Galecto revealed at the time that it had recently wrapped a type C meeting with the FDA and was preparing for a placebo-controlled phase 2 trial in patients with decompensated nonalcoholic steatohepatitis (NASH) cirrhosis that it planned to launch early next year. There’s also an OXL2 inhibitor called GB2064 in a phase 2 trial for myelofibrosis. In its postmarket release yesterday, the company made no mention of whether these plans would be affected by the workforce restructuring or search for strategic alternatives. With $52.1 million in the bank as of the end of June, Galecto CEO Hans Schambye, M.D., Ph.D., had previously said he was optimistic about securing fresh capital to progress the NASH prospect.