GALECTIN THERAPEUTICS INC

Previous wording

The Company also has completed a Hepatic Impairment Study, which ran in parallel with the phase 2b/3 trial as part of the development program. The Hepatic Impairment Study was conducted at three sites and involved approximately 40 patients (divided amongst normal healthy volunteers, and patients with hepatic impairment categorized as Child-Turcotte-Pugh (CTP) classes A (mild), B (moderate), and C (severe). Each subject received a single infusion of belapectin (4 mg/kg LBM) and their serum belapectin levels were monitored for up to approximately two weeks to define the effects of various stages of cirrhosis on serum belapectin levels. The tolerance and safety of belapectin was evaluated. Enrollment in this study was completed in February 2022, and the final results were presented the The Liver Meeting™ 2023, hosted by the American Association for the Study of Liver Diseases. The data indicated that belapectin exposure did not increase with the degree of hepatic insufficiency, a property that is consistent with the observed distribution of the drug into activated macrophages. Further details on this hepatic impairment study can be found onwww.clinicaltrials.gov study NCT04332432.

Current wording

The Company also has completed a Hepatic Impairment Study, which ran in parallel with the phase 2b/3 trial as part of the development program. The Hepatic Impairment Study was conducted at three sites and involved approximately 40 patients (divided amongst normal healthy volunteers, and patients with hepatic impairment categorized as Child-Turcotte-Pugh (CTP) classes A (mild), B (moderate), and C (severe). Each subject received a single infusion of belapectin (4 mg/kg LBM) and their serum belapectin levels were monitored for up to approximately two weeks to define the effects of various stages of cirrhosis on serum belapectin levels. The tolerance and safety of belapectin was evaluated. Enrollment in this study was completed in February 2022, and the final results were presented the The Liver Meeting™ 2023, hosted by the American Association for the Study of Liver Diseases. The data indicated that belapectin exposure did not increase with the degree of hepatic insufficiency, a property that is consistent with the observed distribution of the drug into activated macrophages. Further details on this hepatic impairment study can be found on www.clinicaltrials.gov study NCT04332432.

Previous wording

Three Months Ended March 31, 2024 Compared to Three Months Ended March 31, 2023

Current wording

Three and Six Months Ended June 30, 2024 Compared to Three and Six Months Ended June 30, 2023

Previous wording

Clinical activities decreased primarily due to timing of incurrence of expenditures related to our NAVIGATE clinical trial. Other research and development expenses increased primarily due to additional employees hired after the first quarter of 2023.

Current wording

Clinical activities increased primarily due to timing of incurrence of expenditures related to our NAVIGATE clinical trial. Other research and development expenses increased primarily due to additional employees hired after the first and second quarters of 2023.

Previous wording

General and administrative expenses consist primarily of salaries including stock-based compensation, legal and accounting fees, insurance, investor relations, business development and other office related expenses. The primary reasons for the increase in general and administrative expenses for the three-months ended March 31, 2024 as compared to the same period in 2023 is due to increases in compensation of $85,000 and in investor relations/business development of $95,000 partially offset by decrease in non-cash stock based compensation expenses of approximately $111,000.

Current wording

General and administrative expenses consist primarily of salaries including stock-based compensation, legal and accounting fees, insurance, investor relations, business development and other office related expenses. The primary reasons for the decrease in general and administrative expenses for the three-months ended June 30, 2024 as compared to the same period in 2023 is due to a decrease in stock compensation expense of $31,000 and a decrease in investor relations/business development of $95,000. The primary reasons for the decrease in general and administrative expenses for the six-months ended June 30, 2024 as compared to the same period in 2023 is due to a decrease in legal expense of $69,000 and a decrease in insurance expense of $65,000.

Previous wording

Since our inception on July 10, 2000, we have financed our operations from proceeds of public and private offerings of debt and equity. As of March 31, 2024, we raised a net total of $294.5 million from these offerings. At March 31, 2024, the Company had $23.6 million of unrestricted cash and cash equivalents in addition to $20 million remaining available under two lines of credit provided by our chairman available to fund future operations. The Company believes there is sufficient cash to fund currently planned operations at least through May 15, 2025. We will require more cash to fund our operations after May 15, 2025 and believe we will be able to obtain additional financing. The currently planned operations include costs related to our adaptively designed NAVIGATE Phase 2b/3 clinical trial. 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

Since our inception on July 10, 2000, we have financed our operations from proceeds of public and private offerings of debt and equity. As of March 31, 2024, we raised a net total of $304.5 million from these offerings. At June 30, 2024, the Company had $25.6 million of unrestricted cash and cash equivalents in addition to $10 million remaining available under two lines of credit provided by our chairman available to fund future operations. The Company believes there is sufficient cash to fund currently planned operations approximately through May 15, 2025. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of 12 months from the issuance date of this Form 10-Q. The ability of the Company to continue as a going concern is likely dependent on the results of the Interim Analysis of the Company’s NAVIGATE clinical trial expected in December 2024 and its ability to raise capital; however, the Company’s cash position may not be sufficient to support its daily operations in May 2025. We will require more cash to fund our operations after May 15, 2025 and believe we will be able to obtain additional financing. The currently planned operations include costs related to our adaptively designed NAVIGATE Phase 2b/3 clinical trial. 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.

Previous wording

Net cash used in operations increased by $1,312,000 to $12,105,000 for the three months ended March 31, 2024, as compared to $10,793,000 for the three months ended March 31, 2023. Cash operating expenses increased principally due to the preparations and expenses related to our NAVIGATE clinical trial with belapectin.

Current wording

Net cash used in operations decreased by $188,000 to $20,438,000 for the six months ended June 30, 2024, as compared to $20,626,000 for the six months ended June 30, 2023. Cash operating expenses decreased principally due to timing of payment of expenses related to our NAVIGATE clinical trial with belapectin.