Galectin Aligns With FDA on Belapectin Phase 3 Design
The company said it expects to submit the registrational protocol in the third quarter of 2026 after agreeing on a composite liver outcome endpoint and a single 2 mg/kg dose.
Galectin Therapeutics (GALT), a developer of therapeutics that target galectin proteins, said it reached an agreement with the U.S. Food and Drug Administration on the key elements of a planned Phase 3 trial of belapectin in MASH cirrhosis and portal hypertension, and expects to submit the registrational protocol in the third quarter of 2026.
The alignment covered the primary endpoint of a composite liver outcome, a blinded central review process for endoscopic assessment of esophageal varices, and the use of a single 2 mg/kg lean-body-mass dose of belapectin. Chief Executive Officer Joel Lewis said the company was working diligently toward that submission.
That regulatory path followed a first-quarter preview of an FDA Type C meeting in the second quarter. The agreement also pointed toward potential full approval of belapectin.
Belapectin is a complex carbohydrate drug that inhibits galectin-3, a protein involved in MASH and fibrosis. The lead program remains in MASH with cirrhosis and portal hypertension.
New analyses from the global NAVIGATE Phase 2b/3 trial were presented at the European Association for the Study of the Liver Congress in 2026. An oral presentation by Mazen Noureddin showed belapectin’s impact on fibrosis modulation in high-risk MASH cirrhosis, as reflected by changes in the Pro-C3/CTX-III ratio. Favorable shifts in that ratio were associated with reduced varices development and improvements in liver stiffness measurement and other fibrosis markers.
A poster by Naim Alkhouri, designated a TOP Poster by EASL in the portal hypertension session, included new analyses demonstrating risk reduction in clinically significant portal hypertension. The company published NAVIGATE efficacy results in Hepatology and its central endoscopy review process in Gastro Hep Advances. That review process will also be used in the planned registrational Phase 3 study.
In June 2026, the company hosted an advisory committee meeting with key opinion leaders at the inaugural SOLAR conference.
Research and development expenses were $2.1 million for the quarter ended June 30, 2026, compared with $3.3 million a year earlier. The decrease was primarily due to the timing of expenditures related to the NAVIGATE trial. General and administrative expenses were $1.8 million, versus $1.4 million a year earlier, primarily due to higher non-cash stock-based compensation. Total operating expenses were $4.0 million, producing an operating loss of $4.0 million versus $4.6 million a year earlier.
Net loss applicable to common stockholders was $9.2 million, or $0.14 a share, compared with $7.6 million, or $0.12 a share, a year earlier. The increase was primarily due to a $3.2 million charge for the change in fair value of derivative liabilities, versus a $1.1 million expense a year earlier. Interest expense was $2.0 million.
Cash and cash equivalents were $13.2 million as of June 30, 2026. The company had $10 million remaining available under a line of credit provided by its chairman and believed cash was sufficient to fund currently planned operations and research and development through June 2027.
After quarter-end, Chairman Richard Uihlein converted all outstanding principal and accrued interest under five of six line-of-credit facilities into 34,376,167 shares of common stock, effective July 31, 2026. The transaction eliminated approximately $105.8 million of debt, consisting of $91.0 million in principal and $14.8 million in accrued interest. The December 2025 facility remained undrawn and available. Lewis said the conversion significantly enhanced the capital structure by strengthening the balance sheet.
The registrational Phase 3 protocol submission for belapectin in advanced MASH cirrhosis with portal hypertension is anticipated in the third quarter of 2026.