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Gain Therapeutics, Inc. (GANX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was operationally solid with earlier-than-anticipated completion of Phase 1b enrollment for GT-02287 (16 participants as of June 30) and a 4Q 2025 target for 90-day functional and biomarker analyses, positioning Phase 2 planning for late 2025/early 2026 .
  • EPS of ($0.19) missed Wall Street consensus of ($0.17), while year-over-year losses narrowed on lower R&D and G&A vs Q2 2024; quarter-over-quarter losses increased with higher operating expenses tied to program progression (R&D +$0.5M QoQ; G&A +$0.2M QoQ) .
  • Liquidity declined to $6.7M at quarter-end, but July’s underwritten offering raised ~$7.0M gross (approx. $7.1M net cited by management), extending cash runway beyond Phase 1b completion and supporting IND submission by year-end 2025 .
  • Near-term stock drivers are the 4Q 2025 readouts (MDS-UPDRS and CSF biomarkers), potential approval to extend Phase 1b dosing beyond 90 days, and IND filing enabling U.S. Phase 2 sites .

What Went Well and What Went Wrong

What Went Well

  • Earlier-than-anticipated Phase 1b enrollment completion (16 participants by June 30), enabling consolidated 90-day biomarker analysis in 4Q 2025 and accelerating development timelines .
  • Management signaled growing clinician/patient engagement and requested dosing extension beyond 90 days; “We believe extending the dosing duration will also provide additional valuable feedback we can incorporate into our Phase 2 planning” — Gene Mack, President & CEO .
  • Financing executed immediately post-quarter for ~$7.0M gross proceeds (approx. $7.1M net), improving runway through key data catalysts and into Phase 2 planning .

What Went Wrong

  • EPS missed consensus by $0.02; actual ($0.19) vs ($0.17) consensus, as higher quarter-over-quarter operating expenses drove a larger net loss .
  • Cash declined from $9.07M (Q1) to $6.69M (Q2), underscoring the need for external funding ahead of Phase 2; FX losses of ~$0.62M also weighed on results .
  • No revenue and limited guidance granularity (no quantitative OpEx or margin guidance), which can constrain near-term estimate visibility for investors .

Financial Results

P&L and Expenses vs Prior Year and Prior Quarter

MetricQ2 2024Q1 2025Q2 2025
R&D Expense ($USD Millions)$4.40 $2.26 $2.76
G&A Expense ($USD Millions)$3.75 $2.11 $2.33
Total Operating Expenses ($USD Millions)$8.18 $4.37 $5.09
Net Loss ($USD Millions)$8.14 $4.53 $5.81
Diluted EPS ($USD)($0.42) ($0.16) ($0.19)

Liquidity and Capitalization

MetricQ4 2024Q1 2025Q2 2025
Cash and Equivalents ($USD Millions)$10.39 $9.07 $6.69
Shares Outstanding (Period-End)27,132,588 28,746,041 30,771,321

EPS vs Wall Street Consensus

MetricQ1 2025Q2 2025
EPS Actual ($USD)($0.16) ($0.19)
EPS Consensus Mean ($USD)($0.1667)*($0.1667)*
Revenue Consensus Mean ($USD Millions)$0.00*$0.00*

Values retrieved from S&P Global.*

KPIs (Clinical/Operational)

KPIQ4 2024Q1 2025Q2 2025
Phase 1b Enrollment (participants)Initiated dosing; target 15–20 Enrollment ongoing; target 15–20; completion by end of July 16 enrolled as of June 30; full enrollment expected ≤20
Trial Sites (Australia)Not disclosed7 sites 7 sites
DMC RecommendationNot disclosedNot disclosedContinue study; no dose changes; no serious TEAEs
90-day Readout Timing1st analysis expected end Q2 2025 1st biomarker analysis mid-2025 Consolidated functional and biomarker analysis expected 4Q 2025
Dosing Extension PlanNot disclosedNot disclosedRequest submitted to extend dosing beyond 90 days; update expected in coming weeks

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 1b 90-day biomarker/functional analysis4Q 2025First analysis: end Q2 2025 (Q4 2024 update); mid-2025 biomarker analysis (Q1 2025) Analysis of MDS-UPDRS functional changes and CSF biomarkers consolidated for 4Q 2025 Revised timing (later but consolidated scope)
IND submission (GT-02287)YE 2025IND submission by YE 2025 IND submission by YE 2025 (unchanged) Maintained
Phase 1b dosing duration2H 202590-day dosing per protocol Request submitted to extend dosing beyond 90 days; awaiting approval/update Potentially raised duration (pending)
Cash runway2H 2025Cash $9.07M (3/31/25), no runway comment July offering (~$7.0M gross; ~$7.1M net cited) extends runway beyond Phase 1b completion Improved runway

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript or call resources were found/publicly available .

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q2 2025)Trend
R&D execution (GT-02287)Phase 1b initiated; first analysis end Q2 2025 (Q4 2024) ; first biomarker analysis mid-2025; enrollment ongoing (Q1 2025) Target enrollment completed; 16 participants; consolidated 4Q 2025 analysis Execution progressing, timelines refined
Regulatory path (IND)Pre-IND engagement with FDA; IND by YE 2025 (Q4 2024) IND by YE 2025; expand Phase 2 to U.S. sites Maintained, broader U.S. site ambition
Dosing durationNot discussedRequest to extend beyond 90 days; update imminent Potentially expanded exposure window
Funding runwayCash $10.4M (12/31/24) ; $9.07M (3/31/25) $6.69M (6/30/25) plus ~$7.0M gross offering in July Runway extended via financing
Clinical engagementCAB formed; clinician support ramping (Q4 2024) Strong clinician/patient interest; screening extended to July 31 Increased external engagement

Management Commentary

  • “Reaching target enrollment in the Phase 1b study of GT-02287 during 2Q 2025 was an exciting achievement… we look forward to reporting the analysis of both functional changes and biomarker activity during 4Q 2025… planning the design of our Phase 2 clinical trial… already begun in earnest.” — Gene Mack, President & CEO .
  • “We are further encouraged by clinicians’ request to extend the screening window… and their support to extend the dosing duration… We believe extending the dosing duration will also provide additional valuable feedback we can incorporate into our Phase 2 planning.” — Gene Mack .
  • “The interest we have seen… underscores the significant unmet need for a disease-modifying therapy for Parkinson’s… We believe we are well-positioned to continue executing on our milestones.” — Gene Mack .
  • “The faster-than-anticipated enrollment means all those participants will reach their 90-day visit in time to facilitate biomarker analysis… by fourth quarter of this year instead of the first quarter of 2026.” — Gene Mack .

Q&A Highlights

  • No public Q2 2025 earnings call transcript or call resources were identified; therefore no Q&A highlights or clarifications beyond the press releases are available .
  • Notable press release clarifications: consolidated 4Q 2025 functional and biomarker analysis; dosing extension request; screening extended through July 31 .

Estimates Context

  • Q2 2025 EPS of ($0.19) missed consensus of ($0.17) by $0.02; Q1 2025 EPS was in line with consensus at ($0.16) .
  • Revenue consensus was $0.0 for both quarters, consistent with no reported revenues; investors should anchor models on OpEx, FX, and financing cadence until Phase 2 .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Near-term catalysts concentrated in 4Q 2025: MDS-UPDRS functional scores and CSF biomarker analysis from 90-day Phase 1b dosing; these will shape Phase 2 design and likely estimate revisions .
  • The EPS miss was modest; the quarter-over-quarter step-up in OpEx reflects program execution rather than deterioration in fundamentals; YoY OpEx declines demonstrate discipline via grant/tax credits .
  • July financing extended runway beyond Phase 1b; expect incremental capital ahead of Phase 2 unless partnering proceeds or non-dilutive funding increase .
  • Dosing extension (pending approval) could enhance risk/benefit characterization and strengthen Phase 2 protocol assumptions—focus on safety/tolerability and target engagement indicators .
  • Regulatory momentum intact: IND by YE 2025 and U.S. Phase 2 site expansion aim to broaden clinical footprint and investor interest .
  • Trading implication: stock likely tracks clinical/regulatory news flow; the 4Q 2025 readout is the decisive inflection; interim updates on dosing extension and IND progress are secondary catalysts .
  • Medium-term thesis: GT-02287’s disease-modifying potential and demonstrated target engagement (≥50% GCase activity increase in Phase 1) underpin optionality across PD subtypes and future indications; Phase 2 success is key to valuation upside .