Skip to main content

GALECTIN THERAPEUTICS INC

For the period ended Dec 31, 2024. Filed Mar 31, 2025.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Mar 31, 2025

GALT$3.46+10.2%Stored close · as of Nov 9, 2026

What changed in Risk Factors?

Read the current filing

Previous report: 10-K

Period ended 2023-12-31; filed 2024-03-29.

0001140361-24-016452

Item 1A. Risk Factors

Current report: 10-K

Period ended 2024-12-31; filed 2025-03-31.

0001140361-25-011169

Item 1A. Risk Factors

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 117 previous paragraphs and 120 current paragraphs.

114 unchanged; 3 reworded; 3 added; 0 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 58 previous and 58 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (3)

Current report

Our NAVIGATE trial was our only active clinical trial, and we currently do not have plans or funding to undertake another clinical trial.

Current report

In December 2024, we presented top-line results of the NAVIGATE clinical trial. The composite endpoint did not reach statistical significance. Because the data from NAVIGATE clinical trial did not reach statistical significance, we may determine not to conduct an additional clinical trial to test the efficacy of our drug candidate, belapectin. Furthermore, it will be difficult for us to raise the capital necessary for another clinical trial. The Company continues to analyze data from the 57 patients that completed 36 months of treatment prior to the ending of the trial in February 2025. While data from this group patient would not change the results of results of the NAVIGATE clinical trial, the Company believes that encouraging results from this group of patients may draw interest from potential strategic partners.

Current report

In 2024, we experienced net losses of $47.2 million, had no revenue from operations, and used $41.8 million in cash to fund our operations. Due to the current level of liquidity at December 31, 2024 and the projected shortfall to cover operating expenses requiring cash for a period of 12 months from the report date of the annual report, management has expressed substantial doubt as to our ability to continue as a going concern.
Reworded paragraphs (3)

Previous wording

We have incurred net losses in each year of operation since our inception in July 2000 and have no revenues. Our accumulated deficit as of December 31, 2023 was $354 million. We had $25.7 million of unrestricted cash as of December 31, 2023, $20 million remaining available under a line of credit provided by our chairman, Richard E. Uihlein, and an additional $10 million supplemental line of credit provided also by our chairman. The Company believes there is sufficient cash to fund currently planned operations at least through March 31, 2025. We will require more cash to fund our operations after December 31, 2024 and believe we will be able to obtain additional financing. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.

Current wording

We have incurred net losses in each year of operation since our inception in July 2000 and have no revenues. Our accumulated deficit as of December 31, 2023 was $354 million. We had $15.1 million of unrestricted cash as of December 31, 2024 and $6 million of available borrowings under a line of credit provided by our chairman. Additionally, in March 2025, we signed a new supplemental line of credit agreement with our chairman for an additional $5 million of available borrowings. The Company believes there is sufficient cash, including the $11 million under the two lines of credit, to fund currently planned operations through August 2025. We will require more cash to fund our operations after August 2025. There can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.

Previous wording

Pre-clinical studies and clinical trials are expensive, time-consuming and ultimately may not be successful. The results of pre-clinical and initial clinical testing of these products may not necessarily indicate the results that will be obtained from later or more extensive testing. Also, it is possible to suffer significant setbacks in advanced clinical trials, even after obtaining promising results in earlier trials. For example, although there was positive data from our NASH-CX Phase 2 trial for belapectin, it did not meet its primary endpoint. Similarly, our Phase 2a pilot trial NASH-FX for patients with advanced fibrosis, which explored three non-invasive imaging technologies, did not meet its primary endpoint. An interim analysis for our Phase 2b/3 clinical study, the NAVIGATE trial, is expected in the fourth quarter of 2024. We may engage others to conduct our clinical trials, including clinical research organizations and, possibly, government-sponsored agencies. Additional clinical trials may not start or be completed as we forecast and may not achieve the desired results. The time required to obtain FDA and other approvals is unpredictable but often can take years following the commencement of clinical trials, depending upon the complexity of the drug candidate.

Current wording

Pre-clinical studies and clinical trials are expensive, time-consuming and ultimately may not be successful. The results of pre-clinical and initial clinical testing of these products may not necessarily indicate the results that will be obtained from later or more extensive testing. Also, it is possible to suffer significant setbacks in advanced clinical trials, even after obtaining promising results in earlier trials. For example, although there was positive data from our NASH-CX Phase 2 trial for belapectin, it did not meet its primary endpoint. Similarly, our Phase 2a pilot trial NASH-FX for patients with advanced fibrosis, which explored three non-invasive imaging technologies, did not meet its primary endpoint. Top-line results from the NAVIGATE trial were presented in the December 2024. Again, while there was positive data, especially in the 2 mg cohort, the composite endpoint did not reach statistical significance. We may engage others to conduct our clinical trials, including clinical research organizations and, possibly, government-sponsored agencies. Additional clinical trials may not start or be completed as we forecast and may not achieve the desired results. The time required to obtain FDA and other approvals is unpredictable but often can take years following the commencement of clinical trials, depending upon the complexity of the drug candidate.

Previous wording

A significant percentage of our outstanding stock is held by a limited number of investors, including Richard E. Uihlein. Mr. Uihlein, the chairman of our board of directors, who beneficially owns approximately 16.6% of our outstanding common stock as of February 29, 2024 (which does not include any shares issuable upon exercise of options and warrants) and the 10X Fund, LP , which now owns 9.6% of the issued and outstanding shares of common stock of the Company as of February 29, 2024 (which does not include any shares issuable upon exercise of options and warrants). Mr. Uihlein is also an investor in the 10X Fund as a limited partner but is not deemed to be a beneficial owner of, or have a reportable interest in, any shares owned by 10X Fund. As a result of their ownership of shares of common stock, Mr. Uihlein and 10X Fund have and will have significant influence over corporate actions requiring stockholder approval, including the following actions:

Current wording

A significant percentage of our outstanding stock is held by a limited number of investors, including Richard E. Uihlein. Mr. Uihlein, the chairman of our board of directors, who beneficially owns approximately 16.4% of our outstanding common stock as of February 28, 2025 (which does not include any shares issuable upon exercise of options and warrants nor shares issuable upon conversion of convertible notes and lines of credit) and the 10X Fund, LP , which now owns 9.4% of the issued and outstanding shares of common stock of the Company as of February 28, 2025 (which does not include any shares issuable upon exercise of options and warrants). Mr. Uihlein is also an investor in the 10X Fund as a limited partner but is not deemed to be a beneficial owner of, or have a reportable interest in, any shares owned by 10X Fund. As a result of their ownership of shares of common stock, Mr. Uihlein and 10X Fund have and will have significant influence over corporate actions requiring stockholder approval, including the following actions: