Galecto Reports Financial Results for the Year Ended December 31, 2021
Continued pipeline progress with three potentially first-in-class product candidates
Strong cash position with cash runway into 2H 2024
“During 2021, we made significant progress with our pipeline as we advanced two additional product candidates, GB2064 for myelofibrosis and GB1211 for liver cirrhosis, to Phase 2 clinical testing. With these trials and our ongoing Phase 2b GALACTIC-1 trial for idiopathic pulmonary fibrosis (IPF), we now have three separate ongoing Phase 2 clinical trials and expect to initiate a fourth Phase 2 clinical trial of GB1211 for non-small cell lung cancer (NSCLC) in the first half of 2022,” said Hans Schambye, CEO of
Recent Highlights
- Announced clinical collaboration with Roche for Galecto’s upcoming Phase 2a GALLANT-1 trial of GB1211 in combination with Tecentriq® (atezolizumab) for first-line NSCLC.
- Completed Part 1 and initiated Part 2 and Part 3 of the GULLIVER-2 trial in liver cirrhosis. Part 2 of the trial is designed to assess the effect of 12-week dosing of GB1211 on a wide series of biological markers of hepatic function and structure in participants with moderate hepatic impairment; and Part 3 of the GULLIVER-2 trial is designed to evaluate patients with liver cirrhosis and severe hepatic impairment.
- Strengthened management team with the addition of
Stephanie Oestreich , PhD, MPA, as Chief Business Officer.
Expected Upcoming Milestones
- Completion of enrollment of approximately 141 IPF patients in the GALACTIC-1 Phase 2b clinical trial in Q2 2022.
- Initiation of enrollment in Phase 2a GALLANT-1 trial of GB1211 in combination with Tecentriq® in first-line Non-Small-Cell
Lung Cancer in Q2 2022. - Completion of enrollment in MYLOX-1 Phase 2a trial and GULLIVER-2 Phase 1b/2a trial in Q2 2022.
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; Galecto’s plans for timing of completing enrollment in its GALACTIC-1, MYLOX-1 and GULLIVER-2 trials; Galecto’s plans for initiating its GALLANT-1 trial, 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 |
Financial Tables to Follow
Condensed Consolidated Balance Sheets
(in thousands)
| 2021 | 2020 | ||||
| Cash and cash equivalents | $ | 62,563 | $ | 163,582 | |
| Marketable securities | 37,628 | — | |||
| Prepaid expenses and other current assets | 9,911 | 5,713 | |||
| Marketable securities, long-term | 9,048 | — | |||
| Operating lease right-of-use assets | 834 | 885 | |||
| Other assets | 2,231 | 1,416 | |||
| Total assets | $ | 122,215 | $ | 171,596 | |
| Current liabilities | $ | 4,544 | $ | 5,566 | |
| Operating lease liabilities, noncurrent | 448 | 541 | |||
| Total liabilities | 4,992 | 6,107 | |||
| Total stockholders’ equity | 117,223 | 165,489 | |||
| Total liabilities and stockholders' equity | $ | 122,215 | $ | 171,596 | |
| $ | — | $ | — | ||
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
| For the Year Ended |
||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 38,488 | $ | 24,627 | ||||
| General and administrative | 13,739 | 9,010 | ||||||
| Total operating expenses | 52,227 | 33,637 | ||||||
| Loss from operations | (52,227 | ) | (33,637 | ) | ||||
| Total other income (expense), net | 475 | (1,200 | ) | |||||
| Net loss | $ | (51,752 | ) | $ | (34,837 | ) | ||
| Net loss per common share, basic and diluted | $ | (2.05 | ) | $ | (7.62 | ) | ||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 25,261,832 | 4,572,702 | ||||||
| Other comprehensive gain (loss), net of tax | (994 | ) | 3,125 | |||||
| Total comprehensive loss | $ | (52,746 | ) | $ | (31,712 | ) | ||
Source: Galecto, Inc.