Galecto Reports Third Quarter Operating and Financial Results
“The recent release of positive results from two clinical trials, our Phase 1b/2a GULLIVER-2 trial in decompensated liver cirrhosis and our Phase 2a MYLOX-1 trial in myelofibrosis, has created significant momentum for
- Highlighted by two late-breaking presentations at the AASLD Liver Meeting® 2022, announced positive top-line results from the Phase 1b/2a GULLIVER-2 trial of GB1211, Galecto’s first-in-class, oral small molecule galectin-3 inhibitor candidate, where GB1211 demonstrated a favorable tolerability profile and showed reduced signs of liver impairment in patients with decompensated cirrhosis.
- Announced positive intermediate assessment results from the ongoing Phase 2a MYLOX-1 trial of GB2064, Galecto’s first-in-class, LOXL2 inhibitor candidate, for the treatment of myelofibrosis, 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, an improvement suggesting that GB2064 could impact the progression of the disease and be disease modifying.
- Poster presentation highlighting results from the intermediate assessment of the MYLOX-1 trial to be featured at the 64th
American Society of Hematology(ASH) Annual Meeting and Exposition on December 10-13, 2022in New Orleans, LA.
- Expanded Galecto’s oncology reach by entering into a collaboration agreement for an investigator-initiated Phase 2 trial with
Providence Cancer Instituteto evaluate GB1211 in combination with pembrolizumab (Keytruda®) in patients with metastatic melanoma and head and neck squamous cell carcinoma (HNSCC).
- Published article in the
September 2022 Journal of Medicinal Chemistrydemonstrating that GB1211, the first orally available galectin-3 inhibitor for the treatment of fibrotic disease, is a potent inhibitor of liver and lung fibrosis in both in vitro and in vivo models.
Expected Upcoming Milestones
- Top-line results from Phase 2b GALACTIC-1 trial (IPF) in mid-2023.
- Interim safety data from Phase 2a GALLANT-1 trial (NSCLC) by Q1 2023.
- Initiation of Phase 2 investigator-initiated GB1211 oncology trial (melanoma and HNSCC) by
Providence Cancer Institutein 2023.
Third Quarter 2022 Financial Highlights
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 three months ended
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 assets; Galecto’s plans for timing of initiating and planned readouts of its clinical trials; 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|
|+1 617 430 7577
||+41 78 680 0538|
Financial Tables to Follow
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||28,336||$||62,563|
|Prepaid expenses and other current assets||2,115||9,911|
|Marketable securities, noncurrent||6,829||9,048|
|Operating lease right-of-use assets||852||834|
|Other assets, noncurrent||3,145||2,231|
|Operating lease liabilities, noncurrent||440||448|
|Total stockholders’ equity||72,727||117,223|
|Total liabilities and stockholders' equity||$||82,025||$||122,215|
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
|For the Three Months Ended
||For the Nine Months Ended
|Research and development||$||10,494||$||9,748||$||37,436||$||28,373|
|General and administrative||3,128||3,191||10,246||10,386|
|Total operating expenses||13,622||12,939||47,682||38,759|
|Loss from operations||(13,622||)||(12,939||)||(47,682||)||(38,759||)|
|Total other income (expense), net||(108||)||243||127||416|
|Net loss per common share, basic and diluted||$||(0.54||)||$||(0.50||)||$||(1.88||)||$||(1.52||)|
|Weighted-average number of shares used in computing net loss per common share, basic and diluted||25,491,786||25,261,832||25,342,153||25,261,832|
|Other comprehensive gain (loss), net of tax||(426||)||(335||)||(1,605||)||(763||)|
|Total comprehensive loss||$||(14,156||)||$||(13,031||)||$||(49,160||)||$||(39,106||)|
Source: Galecto, Inc.