Galecto Reports Operating and Financial Results for the Year Ended December 31, 2022
“2022 was an exciting year for us as we continued to progress our pipeline of small-molecule inhibitors of galectin-3 and LOXL2 and we now have three novel compounds in Phase 2 supported by positive clinical data. We are highly encouraged by the clinical results reported in 2022, including with GB1211 in decompensated liver cirrhosis and with GB2064 in myelofibrosis, which provide further evidence of the key roles of galectin-3 and LOXL2 in regulating fibrosis,” said Hans Schambye, CEO of
2022 Highlights
- Completed enrollment for the Phase 2b GALACTIC-1 trial of GB0139 in idiopathic pulmonary fibrosis (IPF) (Q2 2022)
- Initiated Phase 2a GALLANT-1 trial of GB1211 in combination with atezolizumab (Tecentriq®) for first-line treatment of non-small cell lung cancer (NSCLC) (Q2 2022)
- Announced positive intermediate data from the ongoing Phase 2a MYLOX-1 trial where four out of five evaluable patients who received GB2064 for at least six months experienced a ≥ 1-grade reduction in collagen fibrosis of the bone marrow (Q3 2022)
- Announced positive top-line results from the Phase 1b/2a GULLIVER-2 trial where GB1211 demonstrated a favorable tolerability profile and showed reduced signs of liver impairment in patients with decompensated cirrhosis (Q4 2022)
- Expanded oncology reach through a planned investigator-initiated Phase 2 trial with Providence Cancer Institute to evaluate GB1211 in combination with pembrolizumab (Keytruda®) in patients with metastatic melanoma and head and neck squamous cell carcinoma (HNSCC) (Q4 2022)
Anticipated 2023 Milestones
- Top-line results from Phase 2b GALACTIC-1 trial (IPF) (mid-2023)
- Interim safety data from Phase 2a GALLANT-1 trial (NSCLC) (Q2 2023)
- Top-line results from Phase 2a MYLOX-1 trial (myelofibrosis) (Q4 2023)
- Initiation of Phase 2 investigator-initiated GB1211 oncology trial (melanoma and HNSCC) (2H 2023)
Year Ended
Cash, cash equivalents, and investments as of
Research and development expenses were
General and administrative expenses were
Net loss attributable to common stockholders for the year ended
About
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 asset; the potential of Galecto’s product candidates to address significant areas of unmet need; 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,
For more information, contact:
Hans Schambye, CEO |
|
+45 70 70 52 10 | |
Investors/US | Media/EU |
arr@lifesciadvisors.com |
svonderweid@lifesciadvisors.com |
+1 617 430 7577 |
+41 78 680 0538 |
Condensed Consolidated Balance Sheets
(in thousands)
2022 | 2021 | ||||||
Cash and cash equivalents | $ | 32,786 | $ | 62,563 | |||
Marketable securities | 27,438 | 37,628 | |||||
Prepaid expenses and other current assets | 3,686 | 9,911 | |||||
Marketable securities, noncurrent | 5,832 | 9,048 | |||||
Operating lease right-of-use assets | 810 | 834 | |||||
Other assets, noncurrent | 2,636 | 2,231 | |||||
Total assets | $ | 73,188 | $ | 122,215 | |||
Current liabilities | $ | 11,107 | $ | 4,544 | |||
Operating lease liabilities, noncurrent | 328 | 448 | |||||
Total liabilities | 11,435 | 4,992 | |||||
Total stockholders’ equity | 61,753 | 117,223 | |||||
Total liabilities and stockholders' equity | $ | 73,188 | $ | 122,215 |
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
For the Year Ended |
|||||||
2022 | 2021 | ||||||
Operating expenses: | |||||||
Research and development | $ | 48,206 | $ | 38,488 | |||
General and administrative | 13,001 | 13,739 | |||||
Total operating expenses | 61,207 | 52,227 | |||||
Loss from operations | (61,207 | ) | (52,227 | ) | |||
Total other income (expense), net | (417 | ) | 475 | ||||
Net loss | $ | (61,624 | ) | $ | (51,752 | ) | |
Net loss per common share, basic and diluted | $ | (2.43 | ) | $ | (2.05 | ) | |
Weighted-average number of shares used in computing net loss per common share, basic and diluted | 25,409,123 | 25,261,832 | |||||
Other comprehensive gain (loss), net of tax | 76 | (994 | ) | ||||
Total comprehensive loss | $ | (61,548 | ) | $ | (52,746 | ) |
Source: Galecto, Inc.