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GALECTIN THERAPEUTICS INC (GALT)·Q2 2025 Earnings Summary

Executive Summary

  • Losses narrowed materially as OpEx fell post-NAVIGATE: net loss applicable to common improved to $7.58M (−39% y/y) and EPS of −$0.12, better than −$0.20 y/y and −$0.15 q/q . Consensus EPS was −$0.16*, implying a ~$0.04 beat on lower R&D run-rate versus expectations .*
  • Operating discipline: R&D fell to $3.26M (from $9.81M y/y; $6.49M q/q) as NAVIGATE trial spending rolled off; G&A held stable at ~$1.36M .
  • Liquidity extended: cash was $13.77M at 6/30; a new $10M credit line from the Chairman (7/8) pushes runway to at least June 30, 2026 (management also referenced “second half of 2026”) .
  • Clinical narrative: additional NAVIGATE biomarker analyses show sustained liver stiffness benefits and lower variceal incidence at the 2 mg dose, supporting FDA engagement later this year and ongoing partnering discussions .

What Went Well and What Went Wrong

What Went Well

  • Material opex reset post-trial: Total operating expenses declined to $4.63M from $11.29M y/y and from $7.90M q/q, compressing the burn and narrowing the loss .
  • Positive clinical signal durability: Management highlighted sustained reductions in liver stiffness beyond 18 months and alignment with lower varices incidence in the 2 mg arm, reinforcing belapectin’s potential disease-modifying profile in MASH cirrhosis . Quote: “We believe it is especially promising that these findings remain robust in patients who received belapectin beyond 18 months...” — Joel Lewis, CEO .
  • Runway extension and support: New $10M line of credit from Chairman Richard E. Uihlein; company expects liquidity to fund planned ops into mid/2H 2026 .

What Went Wrong

  • No earnings call transcript available: We found no Q2 2025 earnings call transcript; limits visibility into Q&A clarifications (we searched 2025-07-01 to 2025-09-30 and full-year 2025 and found none) [List: 0 earnings-call-transcript].
  • Financing costs remain a headwind: Interest expense rose to $1.83M vs $1.27M y/y (though similar to $1.74M q/q), partially offsetting OpEx savings .
  • Equity deficit and liabilities: Stockholders’ equity deficit was $(118.89)M at 6/30/25 vs $(104.79)M at 12/31/24; total liabilities increased to $132.77M, underscoring reliance on external financing/partnerships .

Financial Results

P&L and Operating Metrics (oldest → newest)

MetricQ2 2024Q1 2025Q2 2025
Net Loss Applicable to Common ($M)$(12.44) $(9.61) $(7.58)
Diluted EPS ($)$(0.20) $(0.15) $(0.12)
Research & Development ($M)$9.81 $6.49 $3.26
General & Administrative ($M)$1.48 $1.41 $1.36
Total Operating Expenses ($M)$11.29 $7.90 $4.63
Interest Expense ($M)$1.27 $1.74 $1.83

Notes: Company remains pre-revenue; gross margin and segment metrics not applicable (no revenue line disclosed in the press release financials) .

Liquidity

MetricDec 31, 2024Mar 31, 2025Jun 30, 2025
Cash & Cash Equivalents ($M)$15.12 $7.43 $13.77
Credit Facility$6M available at 12/31/24 (line) $11M remaining availability at 3/31/25 New $10M line added 7/8/25

Actual vs Consensus (Q2 2025)

MetricConsensusActualSurprise
EPS$(0.16)*$(0.12) +$0.04 (beat)
Revenue ($M)$0.0*n/a (not disclosed in press release) n/a

Values marked with * were retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporate“Through August 2025” (as of Q1) “Through June 30, 2026” in financial highlights; CEO also said “second half of 2026” Raised (noting wording discrepancy)
Credit FacilitiesCorporate$11M remaining across two lines (3/31/25) New $10M line added 7/8/25 Increased financing capacity
Regulatory Next StepsBelapectin (MASH cirrhosis)Share additional biomarker data; engage partners Engage with FDA later this year; continue to explore strategic partnerships Timeline clarified
Data DisclosuresBelapectin (MASH cirrhosis)EASL 2025 presentation (May) with varices and FibroScan® analyses Additional biomarker analyses later this year Maintained cadence

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was found (no transcript documents in the quarter or in 2025) [List: 0 earnings-call-transcript]. Themes below reflect disclosures across earnings materials and press releases.

TopicQ4 2024 (Dec)Q1 2025 (May)Q2 2025 (Aug)Trend
R&D execution / belapectin efficacy2 mg reduced new varices ~49% in PPP; ITT favored but not significant; strong safety MMRM and FibroScan®: significant LSM reductions at W26, W52, W78; fewer patients with >30% worsening; clinical relevance reiterated Durability beyond 18 months; fewer clinically meaningful worsening events; LSM outcomes align with reduced varices; longitudinal data strengthens confidence Reinforcing efficacy signal at 2 mg
Regulatory engagementUpdates planned; assess next steps Preparing additional analyses; partner discussions referenced “Engaging with the FDA later this year” Moving toward regulatory dialogue
SafetyNo drug-related SAEs; AE/SAE rates comparable to placebo Safety profile consistent No new safety issues referenced Stable/positive
Financing runwayCash $27.1M; runway to May 2025 Cash $7.4M; runway to Aug 2025; $11M availability Cash $13.8M at 6/30; new $10M line; runway to at least 6/30/26 Improved runway
PartnershipsExplore partners Continue to engage potential partners “Continuing to explore strategic partnership opportunities” Ongoing

Management Commentary

  • Joel Lewis, CEO: “We believe it is especially promising that these findings remain robust in patients who received belapectin beyond 18 months, reinforcing our belief in the potential of belapectin to modify disease progression in this high-risk population.”
  • Joel Lewis, CEO: “Looking ahead, we remain focused on engaging with the U.S Food and Drug Administration later this year to discuss potential next steps for our program, while also continuing to explore strategic partnership opportunities.”
  • Khurram Jamil, M.D., CMO: “The updated analysis confirms less progression in the belapectin group, further supporting FibroScan® as a meaningful predictive biomarker in this setting.”
  • External KOLs on NAVIGATE (EASL 2025): “Belapectin clearly is showing benefit evidence across several clinically important endpoints and should be continued in clinical development.” — Dr. Naga Chalasani . “Reinforces belapectin’s potential… consistency in benefit with the 2 mg dose in this global study.” — Dr. Naim Alkhouri

Q&A Highlights

  • No Q2 2025 earnings call transcript was available in the period or for 2025; as such, there were no Q&A disclosures to analyze (we searched for “earnings-call-transcript” documents and found none) [List: 0 earnings-call-transcript].

Estimates Context

  • EPS beat: Actual −$0.12 vs consensus −$0.16*, a ~$0.04 upside likely driven by a steeper-than-modeled R&D step-down post-NAVIGATE wind-down .*
  • Revenue: Consensus $0.0*, consistent with a pre-revenue biotech profile; the company did not disclose a revenue line in the press release .*
  • Forward estimate implications: With R&D at $3.26M this quarter (vs $6.49M q/q; $9.81M y/y), the opex base is resetting lower, suggesting sell-side may update out-quarter loss forecasts to be less negative absent new trial starts .

Values marked with * were retrieved from S&P Global.

KPIs (Clinical and Operating)

KPIQ4 2024Q1 2025Q2 2025
Varices incidence reduction (PPP, 2 mg)~49% reduction vs placebo (p<0.05) Consistent with EASL presentations; 2 mg benefit reinforced Narrative emphasizes alignment of LSM and varices reduction; durability beyond 18 months
FibroScan® LSM (2 mg)Trends favorable; details pending Significant mean reductions at W26/W52/W78 (e.g., −4.60 kPa at W52; p<0.0001) Fewer patients with >5 kPa or >30% increases; durable effects into second 18-month period (LOCF)
SafetyNo drug-related SAEs; AEs/SAEs comparable across arms Maintained safety profile No new safety concerns discussed
Cash & equivalents$27.06M at 9/30/24 $7.43M at 3/31/25 $13.77M at 6/30/25; new $10M line in July

Guidance Changes (Detail)

  • Cash runway: Upgraded from “through August 2025” (Q1) to “through June 30, 2026,” with CEO language also referencing “second half of 2026” (note wording discrepancy between narrative and bullet) .
  • Regulatory: Management plans an FDA interaction later this year to discuss next steps for belapectin in MASH cirrhosis/portal hypertension .
  • Data cadence: Additional biomarker analyses planned for later this year; KOL webcast completed in June; EASL data presented in May .

Key Takeaways for Investors

  • The quarter showcased a structurally lower burn: OpEx down ~59% y/y to $4.63M and ~41% q/q, supporting a narrower loss and an EPS beat versus S&P Global consensus .*
  • Clinical momentum remains around the 2 mg dose: durability and biomarker convergence (LSM and varices incidence) strengthen the belapectin thesis ahead of planned FDA engagement .
  • Financing risk mitigated near term: new $10M line and extended runway to at least 6/30/26 provide time for regulatory interactions and partnering discussions .
  • Watch for catalysts: FDA feedback timeline in H2’25, additional biomarker disclosures, and any partnering developments could be stock-moving .
  • Estimate direction: With R&D trending lower post-NAVIGATE, Street EPS loss forecasts may move less negative unless new spend ramps for next-stage development .*
  • Risk balance: Interest expense and equity deficit remain substantial; partnership terms and regulatory clarity will be central to valuation .
  • Positioning: Near-term trading may hinge on FDA meeting visibility and subsequent clarity on registrational strategy; medium-term thesis tied to confirmation of 2 mg efficacy, safety, and pathway to approval/partner financing .

Values marked with * were retrieved from S&P Global.