Highest-materiality recent filing
Galectin reports Q2 net loss $9.2M; FDA agrees on Phase 3 design for belapectin
Net loss $9.2M ($0.14/share) vs $7.6M ($0.12/share) in Q2 2025; R&D $2.1M, G&A $1.8M.
Converted $91.0M principal + $14.8M accrued interest ($105.8M total) into 34,376,167 shares at ~$3.07 blended price.
Galectin reaches FDA agreement on Phase 3 endpoint for belapectin in MASH cirrhosis
FDA agreed on primary endpoint: composite liver outcome including prevention of large esophageal varices (>5 mm).
Galectin Q1 net loss narrows to $5.1M; belapectin data at EASL, FDA meeting ahead
Net loss of $5.1M ($0.08 per share) vs $9.6M ($0.15) in Q1 2025; R&D expense fell to $2.2M from $6.5M.
Galectin Therapeutics reports FY2025 net loss $31M; belapectin data for EASL upcoming
Net loss $31.0M ($0.48/share) vs $47.2M ($0.76) in 2024; R&D expense down to $14.3M from $36.6M.
Galectin Therapeutics receives FDA alignment on belapectin trial design; secures $10M credit line
FDA written response on belapectin shows alignment on patient population for registration trial; follow-up Type C meeting planned.
Galectin reports NAVIGATE biomarker data consistent with clinical benefit; FDA package submitted
In patients with ELF >11.3 (high-risk), new varices occurred in 22.7% on belapectin vs 42.9% on placebo.
Galectin reports Q3 net loss of $0.13/sh; cash $11.5M; NAVIGATE data submitted to FDA
Net loss of $8.2M ($0.13/share) vs $11.2M ($0.18/share) in Q3 2024; R&D spend down to $2.6M as NAVIGATE trial ended.
Galectin Therapeutics presents NAVIGATE trial: belapectin reduces varices, biomarkers improve
Belapectin 2 mg/kg reduced new varices vs placebo across all ELF risk categories at 18 months; in highest risk (ELF>11.3): 22.7% vs 42.9%.
Galectin Q2 net loss $7.6M ($0.12/sh); secures $10M credit line from chairman
Net loss applicable to common stockholders of $7.6M ($0.12 per share) vs $12.4M ($0.20) in Q2 2024.
Richard E. Uihlein provides up to $10M unsecured line of credit; draws through April 2026, principal & interest due Sept 30, 2026.
NAVIGATE trial: belapectin 2mg significantly reduces new varices in MASH cirrhosis patients
In per-protocol, belapectin 2mg reduced new varices incidence at 18 months (p=0.04) vs placebo.
Galectin Therapeutics Q1 net loss $9.6M; Belapectin shows liver stiffness reduction at EASL
Net loss for Q1 2025 was $9.6M ($0.15 per share) vs $11.5M ($0.19) in Q1 2024.
Belapectin shows 49.3% reduction in new varices in MASH cirrhosis patients at EASL 2025
Belapectin 2 mg/kg reduced new varices by 49.3% vs placebo (p=0.04) in per-protocol population (n=287).
Galectin Therapeutics reports FY2024 net loss of $47.2M; NAVIGATE varices reduction in per-protocol
Net loss $47.2M ($0.76/sh) vs $44.5M ($0.74/sh) in 2023; R&D spend $36.6M up from $32.1M.
Galectin reports 68.1% reduction in new varices with belapectin in U.S. patients from NAVIGATE trial
Per-protocol U.S. patients (n=186): 68.1% reduction in new varices with belapectin 2 mg vs placebo (p=0.02).
In ITT (N=355), primary composite endpoint not statistically significant; varices incidence reduced 43.2% with 2mg/kg vs placebo.
Net loss $11.2M ($0.18/share) vs $14.0M ($0.24) in Q3 2023; R&D expense $7.6M, G&A $1.5M.
NAVIGATE Phase 2b/3 trial of belapectin on track for interim top-line analysis in December 2024.
Net loss $11.5M ($0.19 per share) for Q1 2024, unchanged from Q1 2023.
Galectin Therapeutics reports FY2023 net loss of $44.8M; cash runway through March 2025
Net loss applicable to common stockholders of $44.8M ($0.74/share) vs $38.9M ($0.65/share) in FY2022.
Galectin Therapeutics Q3 net loss $14.0M ($0.24/share); chairman exercises warrants for $10M
Net loss $14.0M ($0.24 loss per share) vs $8.6M ($0.14) in Q3 2022; includes $3.6M non-cash deemed dividend from warrant modification.
Galectin Therapeutics Q3 net loss $14M; cash $20.4M; Chairman exercises warrants for $10M
Net loss $14.0M ($0.24/sh) vs $8.6M ($0.14/sh) YoY; includes $3.6M non-cash deemed dividend from warrant modification.
Galectin Q2 net loss $9.2M; NAVIGATE trial interim analysis expected Q4 2024
Net loss per share $0.15 for Q2 2023 vs $0.16 in Q2 2022; R&D expenses $7.4M down from $8.1M.
Galectin Therapeutics Q1 net loss widens to $11.5M; NAVIGATE trial fully enrolled with 357 patients
Net loss of $11.5M ($0.19/shr) vs $9.9M loss in Q1 2022, driven by higher R&D costs.
Galectin Therapeutics reports 2022 net loss of $38.9M; NAVIGATE trial on track
Net loss $38.9M ($0.65/share) vs $30.7M ($0.52) in 2021.
Galectin completes NAVIGATE randomization with 357 patients; topline results Q4 2024
Randomized 357 patients, exceeding initial target of ~315, in Phase 2b/3 belapectin study for NASH cirrhosis.
Galectin completes enrollment in NAVIGATE Phase 2b/3 belapectin study for NASH cirrhosis
309 patients randomized to date; expects 325-340 total by early March 2023.
Galectin reports Q3 2022 net loss $8.6M; NAVIGATE trial 88% enrolled
Net loss $8.6M ($0.14/sh) for Q3 2022, unchanged from Q3 2021.
FDA issued 'Study May Proceed' letter for Phase 2 trial of belapectin + pembrolizumab as first-line therapy for recurrent/metastatic PD-L1 positive head and neck squamous cell carcinoma.
Second DSMB meeting recommends study continue as designed without modifications.
Net loss applicable to common stockholders of $9.7M ($0.16/shr) vs $8.5M ($0.15/shr) in Q2 2021.
Galectin Therapeutics secures $60M credit line from chairman; CEO extends stock compensation
$60M unsecured line of credit from Chairman Richard Uihlein through July 31, 2024; principal & interest due Jan 31, 2026.
Galectin Therapeutics Q1 net loss $9.9M ($0.17/shr); cash runway through May 2023
Net loss of $9.9M for Q1 2022 vs $6.3M in Q1 2021; R&D spend rose to $8.1M (up from $4.9M) on NAVIGATE trial costs.
Dr. Jamil succeeds Dr. Pol Boudes as Chief Medical Officer of the Company, who resigned on July 26, 2024. Dr. Boudes’s last day of employment with the Company is August 1, 2024.
On August 1, 2024, Galectin Therapeutics Inc. (the “Company”) announced the promotion of Dr. Khurram Jamil to Chief Medical Officer effective immediately.
Max materiality 0.85 · Median 0.60 · Most common event other_material