GALECTIN THERAPEUTICS INC

Galectin Therapeutics Inc. is a clinical stage biopharmaceutical company engaged in drug research and development to create new therapies for fibrotic disease, cancer and selected other diseases. The company's drug candidates are based on its method of targeting galectin proteins, particularly galectin-3, which are key mediators of biologic and pathologic functions. The company focuses on diseases with serious, life-threatening consequences and those where current treatment options are limited, specifically in metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis and certain cancer indications.

The company faces intense competition in the biotechnology and pharmaceutical industries from major multinational pharmaceutical and chemical companies, specialized biotechnology firms, and universities and other research institutions. Many of these competitors possess greater financial and other resources, larger research and development staffs and more effective marketing and manufacturing organizations. The company expects increased competition in the area of galectins fueled by a nearly exponential increase in the publication rate of research papers on galectins.

The company generates no revenue from operations as it is a development stage company. Its strategy is to establish and implement clinical development programs that add value to its business in the shortest period of time possible and to seek strategic partners when one of its programs becomes advanced and requires significant additional resources. The company relies on third-party contract research organizations and other vendors to support its clinical trials, and it does not intend to establish internal facilities for the manufacture of its products for clinical or commercial production.

The company's lead galectin-3 inhibitor is belapectin (GR-MD-02), which has been demonstrated in preclinical models to reverse liver fibrosis and cirrhosis and in clinical studies to decrease portal hypertension and prevent the development of esophageal varices. Belapectin has the potential to treat many diseases due to galectin-3's involvement in multiple key biological pathways such as fibrosis, immune cell function and immunity, cell differentiation, cell growth, and apoptosis. The company is using its galectin-3 inhibitor to treat advanced liver fibrosis and liver cirrhosis in MASH patients, having completed two Phase 1 clinical studies, a Phase 2 clinical study in MASH patients with advanced fibrosis (NASH-FX) and a second Phase 2b clinical trial in MASH patients with compensated cirrhosis and portal hypertension (NASH-CX).

The company also has a development pathway in immuno-oncology following a previous successful collaboration with Providence Portland Cancer Center. In 2022, the company filed a new IND with FDA for advanced or metastatic head and neck cancer using belapectin in combination with a checkpoint (PD-1) inhibitor and received a Study May Proceed letter, though the proposed phase 2 trial commencement is dependent on timing of financing. Additionally, through its majority-owned joint venture subsidiary, Galectin Sciences LLC, the company has a discovery program developing small molecules that inhibit galectin-3 and may afford alternative oral drug delivery, with three chemical series of composition of matter patents having been filed.

In December 2024, the company presented top-line results of the NAVIGATE clinical trial. In the intent-to-treat (ITT) population (N=355), while the incidence of varices was 43.2% reduced in the belapectin 2 mg/kg dose group vs placebo, the composite endpoint did not reach statistical significance. In the per-protocol population (PPP) (n=287), the incidence of varices was reduced by 49.3% (compared to the targeted 52.5% reduction) in the belapectin 2 mg/kg dose group (p-value < 0.05). The company further analyzed the two thirds of the completer patients in the NAVIGATE trial enrolled in the U.S. (n=186), where the incidence of varices was significantly reduced by 68.1% (p=0.02) in patients treated with belapectin 2 mg (4 out of 60) vs placebo (13 out of 62). In December 2025, the company announced it will pursue a follow-up Type C meeting with the FDA to finalize remaining components of the next clinical trial design. During 2025, the company received $21,000,000 in proceeds under a convertible line of credit provided by its chairman, $2.3 million in proceeds from exercises of stock options and purchase warrants, and $3.2 million in net proceeds from issuance of shares under its At the Market sales program.

For the year ended December 31, 2025, the company reported a net loss of $30,836,000 ¹ and a net loss applicable to common stockholders of $30,974,000 ², compared to a net loss of $47,047,000 ³ and net loss applicable to common stockholders of $47,200,000 ⁴ in 2024. Basic and diluted net loss per share was $0.48 ⁵ in 2025 versus $0.76 ⁶ in 2024. Total operating expenses decreased to $20,085,000 ⁷ from $42,433,000 ⁸ in the prior year, driven by a reduction in research and development expenses from $36,571,000 ⁹ to $14,290,000 ¹⁰. The company had $17,720,000 ¹¹ of unrestricted cash and cash equivalents as of December 31, 2025, compared to $15,120,000 ¹² at December 31, 2024.

The company believes there is sufficient cash, including $10 million ¹³ under the line of credit provided by its chairman, to fund currently planned operations through April 2027 ¹⁴. The company will require more cash to fund its operations after April 2027, and there can be no assurance that it will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to the company.

The company is pursuing a follow-up Type C meeting with the FDA to finalize remaining components of the next clinical trial design for belapectin. However, the company is only in the preliminary process of advancing belapectin towards clinical development in a pivotal Phase 3 clinical trial, and cannot provide any certainty that a Phase 3 clinical trial will be attempted or completed. A Phase 3 clinical trial would require substantial additional funding, regulatory alignment with the FDA, successful resolution of trial design issues, and other factors that are uncertain at this time.

The company is also pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in immuno-oncology. In 2022, the company filed a new IND with FDA for advanced or metastatic head and neck cancer using belapectin in combination with a checkpoint (PD-1) inhibitor and received a Study May Proceed letter. The proposed phase 2 trial commencement is dependent on timing of financing, and the company is reviewing options for financing this trial which will determine when such trial could commence.

Research and development expenses decreased to $14,290,000 ¹⁵ in 2025 from $36,571,000 ¹⁶ in 2024, primarily due to costs winding down related to the NAVIGATE clinical trial activities and a decrease in costs related to contract manufacturing of belapectin. General and administrative expenses were relatively stable at $5,795,000 ¹⁷ in 2025 compared to $5,862,000 ¹⁸ in 2024.

The company does not intend to establish internal facilities for the manufacture of its products for clinical or commercial production, and instead relies on third-party manufacturers on a purchase-order basis from one of two primary well-known and established pharmaceutical suppliers that meet FDA requirements. The company has experienced, and may experience in the future, certain delays related to global supply chain issues with certain components necessary to manufacture belapectin. As of February 28, 2026, the company had nine full-time employees, six of whom are involved primarily in management of research and development and clinical trials and three who were involved primarily in management and administration.

Expenditures for research and development were $14.3 million ¹⁹ and $36.6 million ²⁰ for the years ended December 31, 2025 and 2024, respectively. There were no equipment purchases or other investing activities in 2025 or 2024. Net cash provided by financing activities was $26,475,000 ²¹ during 2025 as compared to $31,227,000 ²² during 2024. In 2025, the company received $21,000,000 ²³ in proceeds under a convertible line of credit provided by its chairman, $2.3 million ²⁴ in proceeds from exercises of stock options and purchase warrants, and $3.2 million ²⁵ in net proceeds from issuance of shares under its At the Market sales program.

The company's NAVIGATE trial was its only active clinical trial, and the composite endpoint did not reach statistical significance. Because the data from the NAVIGATE clinical trial did not reach statistical significance, the company may determine not to conduct an additional clinical trial to test the efficacy of its drug candidate, belapectin. The company has from time to time faced substantial doubt about its ability to continue as a going concern, and in 2025 experienced net losses of $29.7 million ²⁶, had no revenue from operations, and used $23.9 million ²⁷ in cash to fund its operations.

The company is significantly dependent on Mr. Uihlein, the chairman of its board of directors, for financing, and there is no assurance that he will continue to provide funding. As of December 31, 2025, Mr. Uihlein has provided the company with a line of credit and has made significant equity investments in the company. Mr. Uihlein is under no contractual obligation to provide additional financing to the company beyond his existing commitments, and there can be no assurance that he will continue to provide funding in the future.

The company has incurred net losses in each year of operation since its inception in July 2000 and has no revenues, with an accumulated deficit as of December 31, 2025 of $431 million ²⁸. The company had $17.7 million ²⁹ of unrestricted cash as of December 31, 2025 and $10 million ³⁰ of available borrowings under a line of credit provided by its chairman, and believes there is sufficient cash to fund currently planned operations through April 2027 ³¹, but will require more cash after that date. The company is significantly dependent on Mr. Uihlein for financing, and there is no assurance that he will continue to provide funding. The NAVIGATE trial was the company's only active clinical trial, and the composite endpoint did not reach statistical significance, meaning the company may determine not to conduct an additional clinical trial to test the efficacy of belapectin. The company has identified a material weakness in its internal control over financial reporting related to the valuation of derivative liabilities associated with contingent interest on convertible notes payable.

Management's message emphasizes the company's focus on advancing belapectin for the treatment of MASH cirrhosis and head and neck cancer, highlighting the positive data from the NAVIGATE trial in the per-protocol population and the U.S. subgroup despite the composite endpoint not reaching statistical significance in the ITT population. Management states that the company will pursue a follow-up Type C meeting with the FDA to finalize remaining components of the next clinical trial design. The strategic priorities emphasized for the period ahead include seeking strategic partners when programs become advanced and require significant additional resources, and reviewing options for financing the proposed phase 2 trial in head and neck cancer, which will determine when such trial could commence.