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Gain Therapeutics, Inc. (GANX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 delivered an EPS beat vs Wall Street: diluted EPS of -$0.16 vs consensus -$0.17; revenue remained at de minimis levels typical for development-stage biotech, consistent with expectations. Bolded beat reflects narrower loss than forecasted. *
  • Operating discipline continued: R&D expenses decreased to $2.26M (-$0.20M YoY), while G&A increased modestly to $2.11M (+$0.24M YoY); net loss was -$4.53M versus -$4.01M in Q1 2024. Cash and equivalents were $9.07M, down from $10.39M at 12/31/24.
  • Clinical catalysts remain the primary stock drivers: Phase 1b of GT-02287 in Parkinson’s dosed first participant in March; first biomarker analysis is expected mid-2025, completion targeted for 4Q25, and IND submission by year-end 2025.
  • Near-term investor focus: mid-2025 biomarker readout, Phase 2 planning in 2H25, and funding strategy to support extended development; management reiterated ongoing FDA engagement and IND timing.

What Went Well and What Went Wrong

What Went Well

  • EPS beat: GAAP diluted EPS -$0.16 versus consensus -$0.17, reflecting tighter-than-expected loss per share. Management emphasized operational optimization and grant/tax credits supporting R&D. *
  • Execution milestones: Initiated dosing in Phase 1b PD study in March; seven sites in Australia enrolling; first biomarker analysis expected mid-2025—management views the readout as mechanistic validation and a value inflection point.
  • Strategic momentum: Formation of Clinical Advisory Board and continued FDA dialogue, aiming for IND by year-end; preparation for Phase 2 in 2H25.

What Went Wrong

  • Cash drawdown: Cash/equivalents declined to $9.07M at 3/31/25 from $10.39M at 12/31/24, reflecting operating burn ahead of critical clinical milestones.
  • Net loss widened YoY: Net loss rose to -$4.53M from -$4.01M in Q1 2024, driven by FX and lower interest income, despite R&D optimization and grant/tax benefits.
  • No earnings call/Q&A: The company did not file a Q1 2025 earnings call transcript, limiting real-time guidance elaboration and investor Q&A color. [ListDocuments: earnings-call-transcript found 0]

Financial Results

EPS, Net Loss, and Cash Trend (USD)

MetricQ3 2024Q4 2024Q1 2025
Diluted EPS - Continuing Operations ($)-0.17 -0.14*-0.16
Net Income - (IS) ($USD Millions)-$4.49 -$3.77*-$4.53
Cash And Equivalents ($USD Millions)$12.05 $10.39 $9.07

Note: Asterisked values retrieved from S&P Global.

Operating Expenses (USD) – YoY for Q1

MetricQ1 2024Q1 2025
Research and Development ($USD Millions)$2.51 $2.26
General and Administrative ($USD Millions)$1.87 $2.11
Total Operating Expenses ($USD Millions)$4.38 $4.37

Revenue vs Estimates (USD)

MetricQ3 2024Q4 2024Q1 2025Q1 2025 Consensus
Revenues ($USD Millions)$0.00 ——$0.00

Note: Revenue is typically immaterial for development-stage biotech; Q4 2024 and Q1 2025 revenue were not specifically disclosed in company materials. Consensus values retrieved from S&P Global.

EBITDA and Operating Cash Flow (USD)

MetricQ3 2024Q4 2024Q1 2025
EBITDA ($USD Millions)—-$3.32*-$4.36*
Cash from Operations ($USD Millions)—-$3.45*-$3.82 [GetFinancials]*

Note: Asterisked values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious Guidance (Q4 2024)Current Guidance (Q1 2025)Change
Phase 1b first analysis (biomarkers)Mid-2025End of Q2 2025 Mid-2025 Maintained timing within mid-2025 window
Phase 1b completion4Q25Not explicitly statedCompletion expected 4Q25 New specificity (completion timing)
IND submission (U.S.)2025 YEIND by year-end 2025 IND by year-end 2025 Maintained
FDA engagement2025Pre-IND meeting by YE 2024; expand to U.S. Continued engagement; IND YE 2025 Maintained
Capital runway (context)Through interim analysisSufficient through 2Q 2025 interim analysis Not reiterated in Q1 PR; cash $9.07M Not updated in Q1 PR (context unchanged)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2: Q3 2024)Previous Mentions (Q-1: Q4 2024)Current Period (Q1 2025)Trend
GT-02287 clinical developmentPhase 1 showed ≥53% GCase activity increase; Phase 1b initiation targeted by YE 2024 First participant dosed; first analysis expected end Q2 2025 Phase 1b enrollment ongoing; first biomarker analysis mid-2025; completion 4Q25 Steady progress; timelines broadly maintained
Regulatory/INDPre-IND meeting scheduled by YE 2024 Pre-IND engagement commenced; plan to expand Phase 2 to U.S.; IND YE 2025 Continued FDA engagement; IND YE 2025 Consistent, reinforcing
R&D executionPreclinical data on mitochondrial health; robust dossier expansion Additional Phase 1 safety/exposure data highlighted; advisory board formed Mechanistic biomarker focus; advisory board established Building evidence base
Financing/runwayCash $12.0M at 9/30/24 Cash $10.4M at 12/31/24; runway through interim analysis in 2Q 2025 conveyed in Feb letter Cash $9.07M at 3/31/25 Cash trending lower; focus on partnership/financing optionality
External validationScientific presentations (MDS, MJFF, Neuroscience) Continued conference engagement Ongoing scientific engagement (IAPRD, AD/PD) Sustained visibility

Management Commentary

  • “The first quarter of 2025 marked yet another exciting milestone for Gain with the first administration of GT-02287… We look forward to sharing results from a first biomarker analysis… mid-2025… and anticipate IND submission by year end.” — Gene Mack, President & CEO.
  • “We look forward to incorporating what we learn from the Phase 1b into our Phase 2 planning for GT-02287 in 2H25.” — Gene Mack.
  • Feb letter: “We expect this cash amount to be sufficient to finance operations through our interim analysis… during 2Q 2025… we remain opportunistic with respect to licensing partners and other financing.” — Gene Mack.

Q&A Highlights

  • No Q1 2025 earnings call transcript was filed; therefore, no Q&A disclosures are available for the period. [ListDocuments: earnings-call-transcript found 0]

Estimates Context

  • Q1 2025 diluted EPS came in at -$0.16 vs consensus -$0.17, a beat; revenue was in line with $0.00 consensus typical of development stage firms.*
  • With the near-term catalyst being the Phase 1b biomarker analysis, estimate revisions are more likely to respond to clinical data readouts than incremental opex shifts.*
  • Street coverage remains limited (# of EPS estimates: 3; revenue: 4), amplifying potential volatility around clinical events and financing updates.*

Note: Values retrieved from S&P Global.

Key Takeaways for Investors

  • EPS beat (-$0.16 vs -$0.17) despite minimal revenue baseline underscores ongoing cost control and grant/tax support in R&D. *
  • Clinical execution is on track: first biomarker analysis mid-2025, completion in 4Q25, Phase 2 planning in 2H25, and IND by YE 2025—these are the principal stock catalysts.
  • Cash decreased to $9.07M at quarter-end; expect continued focus on non-dilutive funding/licensing optionality and capital planning around Phase 2.
  • Management reiterated mechanistic thesis for GT-02287 (GCase stabilization/chaperoning with multi-compartment neuroprotection), potentially widening applicability beyond GBA1-PD into idiopathic PD.
  • Near-term trading implications: anticipate heightened event risk into mid-2025 biomarker readout; limited sell-side coverage may amplify move magnitude on new data.*
  • Medium-term thesis: success in biomarker endpoints and favorable safety/tolerability could accelerate Phase 2 timelines and partnering interest; regulatory path appears aligned per ongoing FDA engagement.
  • Monitor opex cadence and FX/interest income volatility given their impact on quarterly net loss variability; cash runway updates and any financing actions will be critical ahead of expanded Phase 2 work.

Appendix: Detailed Data Tables

EPS vs Consensus

MetricQ3 2024Q4 2024Q1 2025Q1 2025 Consensus
Diluted EPS - Continuing Operations ($)-0.17 -0.14*-0.16 -0.17

Note: Asterisked values retrieved from S&P Global.

Net Loss (USD Millions)

MetricQ3 2024Q4 2024Q1 2025
Net Income - (IS)-$4.49 -$3.77*-$4.53

Note: Asterisked values retrieved from S&P Global.

Cash and Equivalents (USD Millions)

MetricQ3 2024Q4 2024Q1 2025
Cash And Equivalents$12.05 $10.39 $9.07

Operating Expenses – YoY Q1 (USD Millions)

MetricQ1 2024Q1 2025Change
Research and Development$2.51 $2.26 -$0.25
General and Administrative$1.87 $2.11 +$0.24
Total Operating Expenses$4.38 $4.37 -$0.01

Selected Quarterly Disclosures

MetricQ3 2024Q4 2024Q1 2025
Weighted Avg Shares (Basic & Diluted)26.53M 27.13M 28.69M
Interest Income, net ($USD)$0.11M $0.36M $0.04M
FX Gain/(Loss), net ($USD)-$0.12M $0.12M -$0.10M

References:

  • Q1 2025 press release and financials:
  • Q1 2025 8-K and Exhibit 99.1:
  • Q4 2024 press release and 8-K:
  • Q3 2024 8-K and financials:
  • Phase 1b dosing announcement:
  • Shareholder letter:

Asterisked values retrieved from S&P Global.