GALECTIN THERAPEUTICS INC (GALT)·Q3 2025 Earnings Summary

Executive Summary

• EPS missed consensus modestly: Q3 diluted net loss per share was $(0.13) vs S&P Global consensus of $(0.11), driven by higher other expense (derivative fair value loss and interest), partially offset by lower R&D as NAVIGATE wound down . Consensus from S&P Global; see Estimates Context for disclaimer.*
• OpEx discipline and YoY improvement: Total operating expenses fell to $4.2m (vs $9.1m in Q3’24), narrowing net loss to $(8.2)m from $(11.2)m YoY, as trial costs declined post-NAVIGATE .
• Liquidity runway extended: Cash was $11.5m at 9/30, plus a $10m chairman-provided credit line; management reiterated funding for planned operations/R&D through June 30, 2026 .
• Clinical/data momentum and upcoming catalyst: New AASLD biomarker analyses reinforced belapectin’s antifibrotic profile (ELF, FibroScan, PRO‑C3, YKL‑40; Baveno VII risk improvement), and the NAVIGATE data package has been submitted to FDA with feedback expected by year-end—key potential stock catalyst .

What Went Well and What Went Wrong

What Went Well

• Strengthened clinical signal: At AASLD, 18‑month biomarker analyses showed consistent effects across FibroScan, ELF, PRO‑C3, and YKL‑40, supporting durable antifibrotic activity and dose response for belapectin 2 mg/kg; CEO: “We continue to see encouraging consistency across key biomarkers…supporting belapectin’s durable antifibrotic activity” .
• Risk stratification improvement: Using validated Baveno VII criteria, belapectin reduced the presence of CSPH with more patients transitioning to lower-risk categories vs placebo over 18 months .
• Regulatory engagement set: NAVIGATE data package submitted; management expects FDA feedback on next steps by year-end, advancing clarity on path forward .

What Went Wrong

• EPS miss vs consensus and other expense drag: Q3 diluted EPS $(0.13) vs $(0.11) consensus, pressured by higher other expense including $(2.2)m derivative fair value loss and $(1.8)m interest expense . Consensus from S&P Global.*
• Persistent stockholders’ deficit and rising liabilities: Stockholders’ deficit widened to $(125.3)m with total liabilities at $136.4m as of 9/30/25 .
• Partnering still pending: Management reiterated that advancing additional clinical programs (e.g., oncology) is largely dependent on securing a partner, keeping non-core pipeline optionality constrained .

Financial Results

Quarterly P&L (USD Millions except per-share)

YoY Comparison (Q3 2025 vs Q3 2024)

Balance Sheet Snapshot (USD Millions)

Note: On July 8, 2025, GALT added a $10m line of credit from its chairman; management expects cash to fund planned operations and R&D through June 30, 2026 .

EPS and Revenue vs S&P Global Consensus

Values retrieved from S&P Global.*
† Company reports no product revenue; quarterly statements present operating expenses and net loss without a revenue line .

Clinical and Program KPIs

• NAVIGATE LSM (FibroScan) worsening thresholds over 18 months (per-protocol):

  • 30% LSM increase: Placebo 23.9% (21/88) vs belapectin 2 mg 11.7% (11/94) vs 4 mg 14.9% (13/87) .

  • 10 kPa absolute increase: Placebo 12.5% (11/88) vs 2 mg 4.3% (4/94) vs 4 mg 10.3% (9/87) .

• Baveno VII CSPH category share change (baseline → 18 months):
  • CSPH: Placebo 34.2%→32.9% (−3.8%) vs 2 mg 33.3%→25.9% (−22.2%) .
  • Probable CSPH: Placebo 21.1%→15.8% (−25.1%) vs 2 mg 24.7%→17.3% (−30.0%) .
  • No/low-risk: Placebo 44.7%→51.3% (+14.8%) vs 2 mg 42.0%→56.8% (+35.2%) .
• AGILE‑4 composite risk: ~32% fewer belapectin 2 mg subjects had ≥20% worsening vs placebo at 18 months .

Guidance Changes

No revenue, margin, OpEx, OI&E, tax, or dividend guidance was provided in Q3 materials .

Earnings Call Themes & Trends

No Q3 2025 earnings call transcript was found in our document set (searched for “earnings-call-transcript” for GALT, none available).

Management Commentary

• “We continue to see encouraging consistency across key biomarkers—including FibroScan, ELF, and PRO‑C3—all supporting belapectin’s durable antifibrotic activity… We submitted the NAVIGATE data package to the FDA…with guidance anticipated by year-end.” — Joel Lewis, CEO .
• “Biomarker analyses provide compelling evidence of belapectin’s biological activity and durability… A clear dose-response [was] observed, reinforcing the biological rationale.” — Khurram Jamil, M.D., CMO .
• “Using Baveno VII… belapectin treatment reduced the presence of clinically significant portal hypertension (CSPH) and lowered the risk of hepatic decompensation… NAVIGATE enrolled one of the most advanced patient populations.” — Company update .

Q&A Highlights

• No Q3 2025 earnings call transcript or Q&A found; no call-based guidance clarifications available in our corpus (searched earnings-call-transcript for GALT; none returned).

Estimates Context

• Coverage remains minimal (1 estimate for EPS and revenue in Q2 and Q3), which limits the statistical significance of “beats/misses.” Q3 EPS $(0.13) vs S&P Global consensus $(0.11); Q2 EPS $(0.12) vs $(0.16) consensus. Revenue consensus was $0 for both quarters, consistent with pre-commercial status . Values retrieved from S&P Global.*
• Given higher other expense in Q3 (derivative fair value loss of $(2.21)m and interest expense of $(1.82)m), estimates may need to reflect volatility in non-operating items as the company manages its capital structure .

Key Takeaways for Investors

• Near-term binary catalyst: FDA feedback on the NAVIGATE data package by year-end could reset the regulatory path and partner interest .
• Clinical de-risking: Multi-biomarker concordance (ELF, FibroScan, PRO‑C3, YKL‑40), Baveno VII risk category improvements, and AGILE‑4 signal strengthen the mechanistic and clinical rationale for belapectin in advanced MASH cirrhosis -.
• Operating discipline: R&D spending is normalizing post-trial, halving OpEx YoY and narrowing losses; monitor sustainability of OpEx run-rate as regulatory workstreams continue .
• Liquidity adequate for planned milestones: $11.5m cash plus $10m credit line with runway through June 30, 2026; watch for additional capital or partnership milestones tied to FDA feedback .
• EPS can be noisy: Non-operating items (derivative fair value changes, interest expense) can drive quarterly EPS variance; Q3 miss vs S&P Global consensus was modest and largely below-the-line . Consensus from S&P Global.*
• Partnering remains a lever: Non-core programs (e.g., oncology) are contingent on partnership—FDA clarity could catalyze BD activity and reduce funding overhang .

Additional Relevant Press Releases (Q3 2025)

• AASLD 2025 participation with NAVIGATE oral/poster presentations, reinforcing visibility of belapectin data in portal hypertension and variceal outcomes -.
• Note: A September 12, 2025 release pertains to Galimedix Therapeutics’ GAL‑101 Phase 1 completion (Alzheimer’s); not a GALT asset and not financially impactful to GALT’s quarter based on available materials -.

Appendix: Source Documents

• Q3 2025 8‑K/Press Release and financial statements -
• Q2 2025 8‑K/Press Release and financial statements -
• Q1 2025 8‑K/Press Release and financial statements -
• AASLD 2025 participation press release -

Values retrieved from S&P Global for consensus figures and related comparisons.*