Washington, D.C. 20549







Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 15, 2021



(Exact name of registrant as specified in its charter)












(State or other jurisdiction

of incorporation)



File Number)


(I.R.S. Employer

Identification No.)

Ole Maaloes Vej 3

DK-2200 Copenhagen N


(Address of principal executive offices, including zip code)

(+45) 70 70 52 10

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(Former Name or Former Address, if Changed Since Last Report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:







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Common Stock, $0.00001 par value per share




The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  





Item 7.01. 

Regulation FD Disclosure.

On March 15, 2021, the Galecto, Inc. (the “Company”) issued a press release announcing the outcome of the independent Data Safety Monitoring Board interim review of the Company’s Phase 2b GALACTIC-1 study of GB0139 for the treatment of Idiopathic Pulmonary Fibrosis.  A copy of the press release is attached hereto as Exhibit 99.1.


The information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01.

Financial Statements and Exhibits.


(d) Exhibits












Press Release issued by the Company on March 15, 2021.










Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.













Galecto, Inc.





Date: March 15, 2021






/s/ Hans T. Schambye







Hans T. Schambye, M.D., Ph.D.







President and Chief Executive Officer




Exhibit 99.1


Galecto Announces Outcome of Data Safety Monitoring Board Interim Review of Phase 2b GALACTIC-1 Study of GB0139 for Idiopathic Pulmonary Fibrosis:

DSMB Recommends Study to Continue with Modifications


Galecto expects to continue dosing patients in the 3 mg arm, whereas the 10 mg arm and combinations with nintedanib or pirfenidone will be discontinued at the recommendation of the DSMB


Boston, Mar. 15, 2021Galecto, Inc. (NASDAQ: GLTO), a biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that an independent Data Safety Monitoring Board (DSMB) has completed its interim review of the company’s Phase 2b GALACTIC-1 study of GB0139 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). On Friday, March 12, the DSMB recommended that, based upon a safety analysis of the data, the company discontinue dosing and enrolling patients in the 10 mg arm along with patients in the 3 mg arm who are receiving combination treatment with the currently approved treatments of IPF, nintedanib and pirfenidone. We expect the 3 mg and placebo arms in patients who are not on concomitant nintedanib or pirfenidone will continue enrolling patients.


GALACTIC-1 is a 52-week randomized, double-blind, multicenter, parallel, placebo-controlled Phase 2b study being conducted across more than 100 centers globally, investigating the safety and efficacy of Galecto’s lead compound, GB0139, in patients with IPF. Initial unblinded data readout is anticipated in 2022.


The DSMB informed the company, based on unblinded safety and efficacy data, that there was an imbalance in the serious adverse experiences across the study groups, but not an imbalance between the groups in mortality. Galecto expects to continue recruiting patients who are not taking nintedanib or pirfenidone at screening and who would be randomized to receive GB0139 3 mg or placebo. The DSMB recommended the patients randomized to the 10mg group and all those taking nintedanib or pirfenidone should be discontinued from the study. Based on these recommendations, the Company plans to work with both the study investigators and the appropriate regulatory authorities to implement these changes promptly.


“Galecto is committed to patient safety and continuing the development of life changing treatments for patients with IPF. Around 50% of IPF patients in Europe and the US do not receive treatment with either pirfenidone or nintedanib, representing a very significant unmet medical need, as they have no available treatment options. Based on our prior phase 1b/2a study of GB0139 in IPF patients, we believe the 3 mg dose has the potential to be an effective clinical dose for these patients,” said Dr. Hans Schambye, CEO



of Galecto. He added “there is a very strong demand for a tolerable alternative to the approved therapies.”  


“We do not expect the recommended changes, which relate solely to the inhaled GB0139 in IPF, to impact any of our other planned trials. We continue to look forward to initiating three additional Phase 2 trials this year with our other clinical stage assets GB2064 (oral LOXL2 inhibitor) and GB1211 (oral Galectin-3 inhibitor). We anticipate completing enrollment in the GALACTIC-1 trial this year with initial data readout in 2022,” added Dr. Schambye.


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


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 GALACTIC-1 trial, including plans for continuing to enroll patients, working with investigators and regulatory authorities, the timing of completing enrollment and the initial unblinded data readout, Galecto’s focus and commitment, GB0139’s potential (including the effectiveness of the 3 mg dose), plans for clinical development (including the timing of their initiation) 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, their therapeutic potential and outcomes related to our clinical trials, our ability to modify the GALACTIC-1 trial protocol to the satisfaction of the FDA or other regulatory agencies, our ability to continue to enroll patients and complete the GALACTIC-1 trial with fewer dosage groups, the risk that FDA or other regulatory agency imposes a clinical hold on the GALACTIC-1 trial, having adequate funds and their use, and those additional risks and uncertainties 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





Ashley R. Robinson

Mary-Ann Chang

+1 617 775 5956

+44 7483 284 853