Galecto Reports Second Quarter Operating and Financial Results
Hans Schambye, CEO of
Dr. Schambye continued, “Beyond our fibrosis programs, we are excited about the advancement of our compounds for the treatment of cancer, beginning with GB1211, a potent small molecule selective oral galectin-3 inhibitor that we are developing for cancer (initially in NSCLC), as well as fibrosis (initially in liver cirrhosis). We believe that both our galectin-3 inhibitors and our collagen-cross linking enzyme, LOXL2, inhibitor could prove to be important tools in the treatment of cancer, as these compounds are designed to enhance the aggressiveness of the immune system on cancer tissue through changing the tumor microenvironment, and also provide direct anti-growth effects on cancer cells. We are on track to have our fibrosis and cancer product candidates in four separate Phase 2 clinical trials by early 2022.”
Recent Highlights & Developments
- Announced that
Galecto has resumed recruiting IPF patients in its GALACTIC-1 Phase 2b trial under a revised protocol that was submitted to theU.S. Food and Drug Administration and other regulatory bodies.Galecto believes that GB0139 is well positioned to address a significant unmet need for a safer and more efficacious treatment. - Announced the results of GB0139 in COVID-19 patients with compromised lung function, which confirmed that the compound was well-tolerated and showed target engagement and highly relevant biological effects.
Expected Upcoming Milestones
- Completion of enrollment in GALACTIC-1 Phase 2b clinical trial in IPF patients in 1H 2022
- Initiation of enrollment in three Phase 2 trials:
- MYLOX-1 trial (myelofibrosis) in Q3 2021
- GULLIVER-2 trial (liver cirrhosis) by Q4 2021
- GALLANT-1 trial (NSCLC) by Q2 2022
Second Quarter 2021 Financial Highlights
Cash, cash equivalents, and marketable securities as of
Research and development expenses were
General and administrative expenses were
Net loss attributable to common stockholders for the three months 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 the company’s observations from its COVID-19 study and the relation of such observations to the treatment of patients with compromised lung function or IPF; GB0139 being well positioned to address a significant unmet need for a safer and more efficacious treatment; the potential role of galectin-3 and LOXL2 inhibitors in the treatment of cancer; Galecto’s ability to complete of enrollment in GALACTIC-1 Phase 2b clinical trial in IPF patients in 1H 2022; Galecto’s initiation of enrollment in three Phase 2 trials: MYLOX-1 trial (myelofibrosis) in Q3 2021, GALLANT-1 trial (NSCLC) by Q2 2022 and GULLIVER-2 trial (liver cirrhosis) by Q4 2021; and Galecto’s expectation that it cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital requirements into the second half of 2024. Such forward-looking statements include statements about Galecto’s focus, plans for clinical development, 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,
For more information, contact:
Hans Schambye, CEO |
|
+45 70 70 52 10 | |
Investor Relations US |
Investor/Media Relations 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 | ||||
(unaudited) | |||||
Cash and cash equivalents | $ | 68,638 | $ | 163,582 | |
Marketable securities | 33,176 | — | |||
Prepaid expenses and other current assets | 5,895 | 5,713 | |||
Marketable securities, long-term | 35,860 | — | |||
Operating lease right-of-use assets | 1,075 | 885 | |||
Other assets | 2,178 | 1,416 | |||
Total assets | $ | 146,822 | $ | 171,596 | |
Current liabilities | $ | 4,755 | $ | 5,566 | |
Operating lease liabilities, noncurrent | 635 | 541 | |||
Total liabilities | 5,390 | 6,107 | |||
Total stockholders’ equity | 141,432 | 165,489 | |||
Total liabilities and stockholders' equity | $ | 146,822 | $ | 171,596 |
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
For the Three Months Ended |
For the Six Months Ended |
||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 8,635 | $ | 4,515 | $ | 18,625 | $ | 9,222 | |||||||
General and administrative | 3,633 | 1,823 | 7,195 | 2,946 | |||||||||||
Total operating expenses | 12,268 | 6,338 | 25,820 | 12,168 | |||||||||||
Loss from operations | (12,268 | ) | (6,338 | ) | (25,820 | ) | (12,168 | ) | |||||||
Total other income (expense), net | (34 | ) | 403 | 173 | 559 | ||||||||||
Net loss | (12,302 | ) | (5,935 | ) | (25,647 | ) | (11,609 | ) | |||||||
Net loss per common share, basic and diluted | $ | (0.49 | ) | $ | (22.83 | ) | $ | (1.02 | ) | $ | (44.66 | ) | |||
Weighted-average number of shares used in computing net loss per common share, basic and diluted | 25,261,832 | 259,966 | 25,261,832 | 259,966 | |||||||||||
Other comprehensive gain (loss), net of tax | 176 | 15 | (428 | ) | (195 | ) | |||||||||
Total comprehensive loss | $ | (12,126 | ) | $ | (5,920 | ) | $ | (26,075 | ) | $ | (11,804 | ) |
Source: Galecto, Inc.