Drug Development and Clinical Trials - The company is developing GB0139, an inhaled small molecule inhibitor of galectin-3, for idiopathic pulmonary fibrosis (IPF), which affects approximately 100,000 people in the U.S.[63] - In the Phase 1b/2a GULLIVER-2 trial for GB1211 in patients with decompensated liver cirrhosis, statistically significant reductions in ALT (p<0.0005), AST (p<0.005), and GGT (p<0.05) were observed after 12 weeks of treatment[67] - The ongoing GALACTIC-1 trial for GB0139 has enrolled 144 patients, with topline results expected in August 2023, focusing on the annual rate of decline in forced vital capacity (FVC) over 52 weeks[65] - GB1211 has shown antifibrotic and anticancer activity in preclinical models and was well-tolerated in a Phase 1 trial involving 78 healthy volunteers[66] - In the MYLOX-1 trial for GB2064, four out of five patients experienced a ≥ 1-grade reduction in collagen fibrosis of the bone marrow after at least six months of treatment, indicating potential disease modification[74] - The company plans to conduct a Phase 2b trial for GB1211 in liver cirrhosis, pending additional financing or collaboration[67] - In the GALLANT-1 trial, initial results showed a partial response in patients receiving GB1211 in combination with atezolizumab, with tumor shrinkage of at least 30% observed[71] - The company has expanded its oncology focus and entered into an agreement for a Phase 2 trial evaluating GB1211 in combination with pembrolizumab for metastatic melanoma and HNSCC patients[72] - GB2064 is being developed as a disease-modifying therapy for myelofibrosis, with the potential to directly impact the fibrotic process[73] - The company is currently conducting three ongoing Phase 2 clinical trials, demonstrating a commitment to advancing its pipeline of novel therapeutics[62] - The MYLOX-1 trial has shown that 4 out of 8 evaluable patients experienced a ≥ 1 grade reduction in collagen fibrosis, indicating GB2064's clinically meaningful antifibrotic activity[76] Financial Performance - For the three months ended March 31, 2023, the net loss was $13.0 million, a decrease of 23.3% compared to a net loss of $16.9 million for the same period in 2022[94] - As of March 31, 2023, the company had $57.2 million in cash, cash equivalents, and marketable securities, expected to fund operations into the second half of 2024[79] - Research and development expenses for the three months ended March 31, 2023, were $10.4 million, down 21.7% from $13.2 million in the same period in 2022[94] - General and administrative expenses decreased to $3.1 million for the three months ended March 31, 2023, from $3.7 million in the same period in 2022, a reduction of 15.5%[96] - The company has not generated any product revenue to date and does not expect to do so until regulatory approval is obtained for its product candidates[80] - The company recorded a tax credit of $0.8 million for each of the three-month periods ended March 31, 2023, and 2022, related to research and development costs[86] - Other income for the three months ended March 31, 2023, was $0.5 million, a significant increase from a de minimis amount in the same period in 2022, primarily due to increased interest income and foreign exchange gains[97] - The company expects to continue incurring net losses and increased expenses as it advances its product candidates through clinical development and seeks regulatory approvals[78] - The company reported net losses of $13.0 million for the three months ended March 31, 2023, compared to $16.9 million for the same period in 2022, indicating a 23% improvement in net losses year-over-year[99] - As of March 31, 2023, the company had an accumulated deficit of $230.7 million and $57.2 million in cash, cash equivalents, and marketable securities[99] - Cash used in operating activities was $9.1 million for the three months ended March 31, 2023, compared to $6.8 million for the same period in 2022, reflecting an increase of 34%[101][102] - The company generated $1.4 million from investing activities during the three months ended March 31, 2023, contrasting with a cash outflow of $10.2 million in the same period of 2022[103][104] - Cash provided by financing activities was $23,000 for the three months ended March 31, 2023, with no financing activities reported in the same period of 2022[105] - The company expects its existing cash and marketable securities will be sufficient to fund operations into the second half of 2024, based on current operating plans[107] - The company anticipates continued increases in research and development expenses, general and administrative expenses, and capital expenditures[106] - The company plans to finance future operations through a combination of equity offerings, debt financings, and other capital sources, which may dilute existing stockholders' ownership[107] Tax and Regulatory Matters - The company has recorded a full valuation allowance against its net deferred tax assets, indicating that it is unlikely to realize these assets in the foreseeable future[120] - The company operates in multiple jurisdictions and is subject to audits from various tax authorities, requiring management's judgment in determining provisions for income taxes and deferred tax assets[122] - As an emerging growth company (EGC), the company can delay the adoption of certain accounting standards until they apply to private companies, which may affect comparability with other public companies[124] - The company may remain classified as an EGC until the end of the fiscal year following the fifth anniversary of its IPO, unless certain thresholds are met, such as a market value exceeding $700 million or annual gross revenues of $1.235 billion[126] - The company is classified as a smaller reporting company, with a market value of shares held by non-affiliates less than $700 million and annual revenue below $100 million[127] Economic and Operational Risks - The company monitors the impact of inflation on its expenses and resources, although its monetary assets are not directly affected by inflation[128] - The company intends to continue using its equipment and believes that inflation related to replacement costs will not materially affect operations[128] - The company is not required to provide quantitative and qualitative disclosures about market risk due to its classification as a smaller reporting company[129] - The ongoing economic challenges from COVID-19 and geopolitical tensions may adversely affect the company's financial condition and operations[82]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39655 GALECTO, INC. (Exact name of Registrant as specified in its Charter) | Delaware | 37-1957007 | | --- | --- | | (State or other ...

·♪Galecto First-in-class small-molecule anti-fibrotic and anti-cancer agents May 2021 Forward-looking statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding Galecto, Inc.'s (the "Company") strategy, future operations, future financial position, projected costs, prospects, plans, and objectives, are forward-looking statements. Su ...