GLTO Galecto Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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GB0139
Idiopathic pulmonary fibrosis (IPF)
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Phase 2b
Phase 2b
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|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
GB2064
Myelofibrosis
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Phase 2
Phase 2
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Phase 2 trial to be initiated early 2021.
|
|
GB1211
Nonalcoholic steatohepatitis (NASH)
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Phase 2a
Phase 2a
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Phase 2a trial to be initiated early 2021.
|
Latest News
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BOSTON, Feb. 09, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced Hans Schambye, the Company's Chief Executive Officer, will participate in multiple upcoming investor conferences. Dr. Schambye and Jon Freve, the Company's Chief Financial Officer, will be available for 1x1 meetings with investors at all meetings. Details are as follows:
SVB Leerink 10th Annual Global Healthcare Conference – Presenting on Wednesday, February 24, 2021 at 9:20 AM ET and hosting investor meetings on the same date
Credit Suisse London Global Healthcare Conference – Hosting investor meetings Tuesday, March 2 through Thursday, March 4, 2021
Oppenheimer 31st Annual Healthcare Conference – Presenting on Tuesday, March 16, 2021 at 8:00 AM ET and hosting investor meetings on the same date
A live webcast of the available presentations will be posted under the Investor section of the Company's website at www.galecto.com. A replay of each available presentation will be available for 30 days following the event.
About Galecto
Galecto (NASDAQ:GLTO) is a clinical stage biotechnology company incorporated in the U.S. with advanced programs in fibrosis and cancer centered on the development of small-molecule inhibitors of galectin-3 and lysyl oxidase-like 2, or LOXL2, which play key roles in regulating fibrosis. The Company's pipeline includes our lead product candidate, which is an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis. Our pipeline also includes two additional assets about to move into phase 2 studies.Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com.
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 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, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto's product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto's filings with the Securities and Exchange Commission. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.For more information, contact:
Galecto Inc. Hans Schambye, CEO
Jon Freve, CFO+45 70 70 52 10
Investors/US
Media/EUAshley R. Robinson
[email protected]Mary-Ann Chang
[email protected]+1 617 775 5956 +44 7483 284 853 
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BOSTON, Jan. 08, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc., (NASDAQ:GLTO) a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the appointment of Dr. Anne Prener to its Board of Directors.
"We warmly welcome Anne to our Board. She will be a tremendous asset with her deep experience and exceptional leadership qualities," said Hans Schambye, CEO of Galecto. "Anne brings to our Board a unique perspective after having served as CEO on several companies; she is an accomplished and seasoned executive, and we welcome her guidance."
Dr. Anne Prener noted, "I am delighted to join this dynamic company's Board of Directors. Galecto has an exciting pipeline of product candidates within fibrosis and cancer and a lead candidate in phase 2 for Idiopathic pulmonary fibrosis (IPF). After reviewing the accomplishments and the opportunities that lie ahead, I believe in management's vision and opportunity to make a meaningful difference in the lives of patients suffering from IPF."
Dr. Anne Prener has more than 25 years of leadership experience within life sciences companies, and currently serves as Chief Executive Officer of Imbria Inc. and as venture partner at SV Health Investors. Dr. Prener previously served as CEO of Freeline Ltd. Dr. Prener has led companies and teams across several therapeutic areas, including a focus on rare diseases. As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform. Prior to joining Freeline, she served as CEO of Gyroscope Therapeutics Ltd., a gene therapy company focused on eye diseases. Before that, Dr. Prener was Global Therapeutic Area Head of Hematology and Vice President, Clinical Research Hematology at Baxalta. During her time there, three new major product approvals in the U.S. and EU were secured along with a significant advancement in Baxalta's hematology portfolio. Earlier in her career, Dr. Prener held several positions of increasing responsibility at Novo Nordisk, most recently serving as Senior Vice President, Hemophilia R&D Portfolio, where she was instrumental in building a portfolio of late stage and commercial hemophilia products. Dr. Prener serves on the Boards of Directors of several life science companies, Rubius Therapeutics, Kaleido Bioscience and Renovacor. Dr. Prener holds a Ph.D. in epidemiology and an M.D., both from the University of Copenhagen.
About Galecto
Galecto (NASDAQ:GLTO) is a clinical stage biotechnology company incorporated in the U.S. with advanced programs in fibrosis and cancer centered on the development of small-molecule inhibitors of galectin-3 and lysyl oxidase-like 2, or LOXL2, which play key roles in regulating fibrosis. The company's pipeline includes our lead product candidate, which is an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis. Our pipeline also includes two additional assets about to move into phase 2 studies.Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com.
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 focus, GB0139's potential, plans for clinical development and potential to market, and Galecto's 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, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto's product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto's filings with the Securities and Exchange Commission. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.For more information, contact:
Galecto Inc. Hans Schambye, CEO Jon Freve, CFO +45 70 70 52 10 Investors/US Media/EU Ashley R. Robinson Mary-Ann Chang [email protected] [email protected] +1 617 775 5956 +44 7483 284 853 -
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BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that Hans Schambye, Chief Executive Officer, will participate in two panel discussions at the LifeSci Partners 10th Annual Healthcare Corporate Access Event, which is being held virtually from January 6-8 and 11-14.
The first panel, entitled "Separating the Wheat from the Chaff: Most Promising Novel Oncology Targets in Development", takes place on Thursday, January 7, 2021 at 8:00AM Eastern Standard Time. Investors can pre-register for this panel discussion here.
The second panel, titled "EU Companies IPO-ing in the US: Benefits of EU Companies Listing on NASDAQ", is also on Thursday, January 7, 2021 at 10AM EST. Investors can pre-register for this panel discussion here.
In addition, investors interested in meeting with our management team to learn more about Galecto and our pipeline can schedule a 1:1 to meet with us here.
About Galecto
Galecto is a clinical stage biotechnology company incorporated in the U.S. with advanced programs in fibrosis and cancer centered on galectin-3 and LOXL2. The company's pipeline includes an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis, as well as two additional assets about to move into phase 2.Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com.
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 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, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto's product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto's filings with the Securities and Exchange Commission. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.For more information, contact:
Galecto Inc. Hans Schambye, CEO
Jon Freve, CFO+45 70 70 52 10
Investors/US
Media/EUAshley R. Robinson
[email protected]Mary-Ann Chang
[email protected]+1 617 775 5956 +44 7483 284 853 
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Successfully completed listing on US Nasdaq and raised over $150 million during recent IPO and preceding crossover round
Funds to support preparations for potential EU conditional approval of GB0139 in IPF and multiple new Phase 2 clinical trials
BOSTON and COPENHAGEN, Denmark, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Galecto, Inc., a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the third quarter ended September 30, 2020 and provided a corporate update.
Recent Highlights
- Successfully completed an Initial Public Offering (IPO) with shares beginning trading on the Nasdaq Global Market on October 29, 2020 under the ticker symbol "GLTO." The Company raised approximately $150 million in total funds during the recent IPO and preceding crossover investment round.
- Published full results from its Phase 2a study of GB0139 in Idiopathic Pulmonary Fibrosis (IPF) in the peer-reviewed European Respiratory Journal. Data from the trial demonstrated inhaled GB0139 showed major effects on IPF biomarkers, including YKL-40 (which has been linked to IPF mortality) and CCL-18 (which has been linked to a decrease in lung function). These and several other biomarkers (PDGF-B, PAI-1, Galectin-3) were reduced in a dose dependent fashion from baseline in a consistent and statistically significant manner, with the strongest effects in the 10 mg dose group compared to placebo.
- Presented Phase 1 clinical data at the American Chemical Society (ACS) Fall virtual meeting on GB1211, the Company's potent and selective oral small molecule galectin-3 inhibitor, showing that it is well tolerated.
- Received Orphan Drug Designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for GB0139 in the treatment of IPF. The EMA cited clinically relevant biomarker data in IPF patients as a justification for the ODD designation, providing financial incentives to encourage the development of drugs to treat rare diseases.
- Strengthened is Board of Directors with the appointment Jayson Dallas, a seasoned executive with global experience in both the pharmaceutical and biotech industries.
"We have made tremendous progress both clinically and as a company, and are excited to have successfully completed our IPO in the US," said Hans Schambye, CEO of Galecto. "We are well positioned to execute on all of our strategic goals, and look forward to continue building on our momentum as we advance on our promising GB0139 product candidate and expand our clinical development pipeline with the initiation of three Phase 2 studies for other product candidates."
Third Quarter 2020 Financial Highlights
- Cash, cash equivalents, and investments as of September 30, 2020 were $85.3 million. As of November 30, 2020, cash, cash equivalents, and investments were $168.4 million, which includes the net proceeds raised in our recent IPO.
- Research and Development expenses for the three months ended September 30, 2020 were $7.7 million, compared to $3.7 million for the three months ended September 30, 2019. The increase of $4.0 million was primarily related to an increase in clinical expenses, including an increase in chemistry, manufacturing and control, or CMC, activities, and expenses related to our Phase 2b study of GB0129 and preparations for a Phase 2a study of GB1211.
- General and administrative expenses were $2.5 million for the three months ended September 30, 2020, compared to $1.2 million for the three months ended September 30, 2019. The increase of $1.3 million was primarily related to an increase in consultant costs, accounting fees, and an increase in personnel costs, partially offset by a decrease in legal fees.
- Net loss attributable to common stockholders for the three months ended September 30, 2020 was $14.4 million or ($55.25) per basic and diluted share, compared with $5.5 million, or ($21.18) per basic and diluted share, for the prior year period.
About Galecto
Galecto is a clinical stage biotechnology company with advanced programs in fibrosis and cancer centered on galectin-3 and LOXL2. The company's pipeline includes an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis, as well as two assets about to move into phase 2 targeting myelofibrosis, NASH and oncology. The Company is incorporated in the U.S. and has its operating headquarters in Copenhagen, Denmark.Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com.
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 focus, GB0139's potential, plans for clinical development and potential to market, and Galecto's 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, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto's product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto's filings with the Securities and Exchange Commission, including its Registration Statement on Form S-1. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
For more information, contact:Galecto Inc. LifeSci Advisors (media) Hans Schambye, CEO Mary-Ann Chang Jon Freve, CFO
+45 70 70 52 10+44 7483 284853 [email protected] [email protected] Financial Tables to Follow
GALECTO, INC.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)September 30, December 31, 2020 2019 Cash and cash equivalents $85,333 $11,294 Receivable on issuance of convertible preferred stock 5,473 39,669 Prepaid expenses and other current assets 5,337 5,117 Operating lease right-of-use assets 905 298 Other assets 1,106 231 Total assets $98,154 $56,609 Current liabilities $8,281 $7,927 Operating lease liabilities, noncurrent 589 211 Total liabilities 8,870 8,138 Total stockholders' equity 89,284 48,471 Total liabilities and stockholders' equity $98,154 $56,609 GALECTO, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(Unaudited)For the Three Months Ended
September 30,For the Nine Months Ended
September 30,2020 2019 2020 2019 Operating expenses: Research and development $7,651 $3,674 $16,874 $11,893 General and administrative 2,515 1,152 5,461 2,224 Total operating expenses 10,166 4,826 22,335 14,117 Loss from operations (10,166) (4,826) (22,335) (14,117) Total other income (expense), net (1,485) 721 (925) 2,033 Net loss (11,651) (4,105) (23,260) (12,084) Dividends on convertible preferred stock (2,713) (1,401) (7,648) (4,159) Net loss attributable to common stockholders $(14,364) $(5,506) $(30,908) $(16,243) Net loss per common share, basic and diluted $(55.25) $(21.18) $(118.89) $(62.48) Weighted-average number of shares used in computing net loss
per common share, basic and diluted259,966 259,966 259,966 259,966 Other comprehensive loss Net loss (11,651) (4,105) (23,260) (12,084) Currency translation 2,331 (2,059) 2,136 (2,140) Total comprehensive loss $(9,320) $(6,164) $(21,124) $(14,224) - Successfully completed an Initial Public Offering (IPO) with shares beginning trading on the Nasdaq Global Market on October 29, 2020 under the ticker symbol "GLTO." The Company raised approximately $150 million in total funds during the recent IPO and preceding crossover investment round.
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- The ERJ Paper shows major effects on biomarkers in IPF, linked to mortality and to fall in FVC
- The inhaled GB0139 significantly reduced key plasma biomarkers from baseline vs placebo over 2 weeks
- GB0139 is being investigated in the 450 patients, 52 week GALACTIC-1 Phase 2b/3 trial in IPF
BOSTON and COPENHAGEN, Denmark, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Galecto, Inc., a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, announced today the publication of a paper detailing full results from a phase 2a study of GB0139 in Idiopathic Pulmonary Fibrosis (IPF) in the peer-reviewed publication European Respiratory Journal.
The study highlights the effect of inhaled GB0139 in IPF patients on the plasma levels of highly relevant disease biomarkers, in particular YKL-40 and CCL-18, which have been shown to have prognostic significance in IPF (YKL-40 linked to IPF mortality and CCL-18 linked to fall in lung function – FVC). These and several other biomarkers (PDGF-B, PAI-1, Galectin-3) were reduced in a dose dependent fashion from baseline in a consistent and statistically significant manner, with the strongest effects in the 10 mg dose group compared to placebo.
Hans Schambye, CEO of Galecto, said: "We are excited that the study showed that with intervention with our inhaled small molecule therapy GB0139 in the lungs of IPF patients, we see fast onset and major reduction in a series of biomarkers known as drivers of lung fibrosis and linked to IPF mortality. GB0139's concerted and marked impact on these biomarkers support its potential to make a significant difference in the treatment of IPF, and we are looking forward to advancing it further through clinical development and potentially to market."
GB0139, an inhaled small molecule inhibitor of galectin-3, a protein known to play a central role in fibrosis in several organs, has received Orphan Drug Designation (ODD) from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of IPF. The EMA cited clinically relevant biomarker data, in particular the significant reduction of YKL-40 in IPF patients, as a justification for the ODD designation. GB0139 was shown to be safe and well tolerated in healthy subjects and IPF patients in the phase 2a trial, and dose dependently suppressed expression of galectin-3, a protein known to play a central role in fibrosis in several organs, on alveolar macrophages.
"The availability of multiple biomarkers of IPF pathogenesis means physicians can not only monitor the progression of disease but also differentiate the effects of different treatments. The lockstep reduction in five biomarkers – PDGF-BB, PAI-1, Galectin-3, CCL18 and YKL-40 – in patients treated with TD139, but not with placebo, is an encouraging early sign that will require clinical confirmation," said Toby Maher, one of the authors of the paper and Professor at Royal Brompton Hospital, Imperial College London and University of Southern California.
Galecto is now investigating GB0139 (formerly TD139) in the Phase 2b/3 GALACTIC-1 clinical trial in IPF. The trial is a pivotal size, randomized, double-blind, multicenter, parallel, placebo-controlled study across more than 100 centers in the U.S., the EU, and Canada, designed to evaluate the efficacy and safety of GB0139 in 450 subjects with IPF over 52 weeks.
About Galecto
Galecto is a clinical stage biotechnology company with advanced programs in fibrosis and cancer centered on galectin-3 and LOXL2. The company's pipeline includes an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis, as well as two assets about to move into phase 2 targeting myelofibrosis, NASH and oncology. The Company is incorporated in the U.S. and has its operating headquarters in Copenhagen, Denmark.Further information can be found at www.galecto.com.
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 focus, GB0139's potential, plans for clinical development and potential to market, and Galecto's 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, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto's product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto's filings with the Securities and Exchange Commission, including its Registration Statement on Form S-1. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
For more information, contact:Galecto Inc. LifeSci Advisors (media) Hans Schambye, CEO
Jon FreveMary-Ann Chang +45 70 70 52 10 +44 7483 284 853 [email protected] [email protected]