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MI

MetaVia Inc. (MTVA)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 reduced operating expenses and narrowed net loss: net loss was $3.67M ($0.36 per share) vs $6.71M ($1.32) in Q1 2024; cash was $11.2M at quarter-end, and the $10.0M private placement extends runway into 2026 .
  • DA-1726 (GLP-1/glucagon dual agonist) Phase 1 MAD Part 2 showed compelling signals: maximum weight loss of 6.3% and mean of 4.3% at 32 mg without titration, favorable cardiovascular profile (no QTcF prolongation; mean heart rate decreased in most cohorts); higher-dose cohorts planned to define MTD .
  • DA-1241 (GPR119 agonist) Phase 2a 16-week data presented at EASL: significant ALT reduction (-22.8 U/L), CAP improvement (23.0 dB/m), improved FAST score, and glycemic control; end-of-Phase 2 FDA meeting targeted in H1 2025 .
  • Stock reaction catalysts: Q4 2025 readouts from additional DA-1726 cohorts; funding clarity and ongoing DA-1241 regulatory interactions support near-term narrative .

What Went Well and What Went Wrong

What Went Well

  • “We are now well capitalized into 2026 after a successful private placement of $10 million… The data reinforce DA-1726’s strong potential as a best-in-class therapy,” CEO Hyung Heon Kim (weight loss max -6.3%, mean -4.3%; early satiety 83%; waist -1.6 inches mean, -3.9 inches max; fasted glucose max -18 mg/dL; no QTcF prolongation) .
  • DA-1241 delivered significant multi-dimensional improvements in presumed MASH patients (ALT -22.8 U/L; CAP -23.0 dB/m; FAST declined; inflammation and fibrosis biomarkers improved; HbA1c reductions up to 1.08%p in T2D subgroup), and was well tolerated .
  • Operating discipline: R&D expense cut to $2.33M and G&A to $1.56M in Q1 2025, driving total OpEx down to $3.89M and narrowing net loss vs prior year .

What Went Wrong

  • No product revenue; the company remains pre-commercial with losses from operations equal to total operating expenses (no revenue line reported) .
  • Cash declined to $11.2M from $16.0M at year-end, highlighting funding dependence on external capital (alleviated by $10.0M private placement) .
  • GI-related AEs observed at 32 mg DA-1726 (vomiting 50%, nausea 33.3%, constipation 33.3% at cohort-level), though largely mild/transient; continued need to validate tolerability at higher doses and longer durations .

Financial Results

Income Statement (Quarterly)

MetricQ1 2024Q1 2025
Revenue ($USD Millions)$0.0 $0.0
R&D Expense ($USD Millions)$4.904 $2.327
G&A Expense ($USD Millions)$1.977 $1.559
Total Operating Expenses ($USD Millions)$6.881 $3.886
Other Income ($USD Millions)$0.167 $0.215
Net Loss ($USD Millions)$(6.714) $(3.671)
Diluted EPS ($USD)$(1.32) $(0.36)
Weighted Avg Shares (Basic & Diluted)5,089,408 10,264,202

Notes: No revenue reported (pre-commercial). Margin metrics are not meaningful given zero revenue .

Balance Sheet Snapshots

MetricDec 31, 2024Mar 31, 2025
Cash and Equivalents ($USD Millions)$16.017 $11.190
Total Assets ($USD Millions)$16.260 $12.127
Total Liabilities ($USD Millions)$8.329 $7.747
Stockholders’ Equity ($USD Millions)$7.931 $4.380
Accounts Payable ($USD Millions)$3.879 $3.054
Clinical Trial Accrued Liabilities ($USD Millions)$1.696 $1.230
Related Party Payable ($USD Millions)$1.472 $2.375
Warrant Liabilities ($USD Millions)$0.361 $0.274

Pipeline KPIs (Clinical Signals This Quarter)

KPIPeriod/SettingValue
DA-1726 Weight Loss (Max, 32 mg)Phase 1 MAD, Day 26-6.3%
DA-1726 Weight Loss (Mean, 32 mg)Phase 1 MAD, Day 26-4.3%
DA-1726 Fasted Glucose (Max)Phase 1 MAD, Day 26-18 mg/dL
DA-1726 Waist Circumference (Mean/Max)Phase 1 MAD-1.6 in mean; -3.9 in max
DA-1726 CardiovascularPhase 1 MADNo QTcF prolongation; mean HR decreased in most cohorts
DA-1241 ALT ReductionPhase 2a 16-week-22.8 U/L (100 mg)
DA-1241 CAP ImprovementPhase 2a 16-week-23.0 dB/m
DA-1241 HbA1c ReductionPhase 2a 16-weekUp to -1.08%p in T2D subgroup

Estimate Comparison

MetricConsensus (S&P Global)Actual Q1 2025
EPS ($USD)N/A*$(0.36)
Revenue ($USD Millions)N/A*$0.0

*S&P Global analyst consensus data unavailable for MTVA Q1 2025. Values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayOperations fundingInto Q3 2025 Into 2026 (with $10.0M private placement) Raised
DA-1726 Additional SAD/MAD Cohorts (MTD)Start/Data timingNot specified previouslyBegin Q3 2025; data Q4 2025 New/Specified
DA-1241 End-of-Phase 2 MeetingTimingH1 2025 targeted H1 2025 expected Maintained
Financial Guidance (Revenue/Margins/OpEx)FY/Q2+None provided None provided Maintained

Earnings Call Themes & Trends

Note: No earnings call transcript was available; themes reflect management’s press releases.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q1 2025)Trend
DA-1726 efficacy & tolerabilityAnticipated MAD Part 2 data; intent to add cohorts to explore MTD Reported MAD Part 2 with strong weight loss, glucose, waist reduction; plan higher-dose cohorts; favorable CV safety Strengthening efficacy signals; advancing dose exploration
DA-1241 MASH programPositive topline 16-week results; plan EOP2 meeting Detailed EASL poster: ALT/CAP/FAST/NIS-4 improvements; glycemic control; well tolerated Continued progress; expanding clinical validation
Funding & runway$16.0M cash; runway into Q3 2025 $10.0M private placement; runway into 2026 Improved capital position
Regulatory interactionsEOP2 meeting planned H1 2025 EOP2 expected H1 2025 On track
Safety (CV/HR/QTcF)Not highlightedNo QTcF prolongation; mean HR declined in most cohorts despite dual agonism Favorable safety narrative

Management Commentary

  • “We are now well capitalized into 2026 after a successful private placement of $10 million… [DA-1726]… dose-dependent weight loss, reaching a maximum reduction of 6.3% and a mean reduction of 4.3% at the 32 mg dose at Day 26… cardiovascular safety remained favorable, with no QTcF prolongation and a decrease in mean heart rate across most cohorts” — Hyung Heon Kim, President & CEO .
  • “Building on these encouraging findings, we are initiating higher-dose cohorts to identify the maximum tolerated dose and further unlock DA-1726’s full therapeutic potential” — Hyung Heon Kim .
  • “The full data from our Phase 2 clinical study… confirm that DA-1241 is the first oral GPR119 agonist to demonstrate both hepatoprotective and glucose-regulating effects… significantly reduced key markers of liver injury, inflammation, and fibrosis… efficiently improved glycemic control” — Hyung Heon Kim .

Q&A Highlights

  • No formal Q&A transcript was published; key clarifications are embedded in press releases: DA-1726 higher-dose cohorts and Phase 1 Part 3 including Wegovy early drop-outs to evaluate tolerability and efficacy; cardiovascular profile characterized as favorable in Phase 1 .
  • DA-1241 regulatory path: end-of-Phase 2 meeting planned/expected H1 2025; poster detailed biomarker and NIT improvements .

Estimates Context

  • S&P Global Wall Street consensus for Q1 2025 EPS and Revenue was unavailable for MTVA; hence estimate comparisons are not shown. Actual EPS was $(0.36) and revenue $0.0 for Q1 2025 . Values retrieved from S&P Global.

Key Takeaways for Investors

  • Operating discipline drove a significantly narrower quarterly loss; with no product revenue, cost control remains the lever to manage cash burn .
  • The $10.0M private placement and reduced OpEx extend runway into 2026, reducing near-term financing overhang and enabling execution of planned DA-1726 higher-dose cohorts and DA-1241 regulatory steps .
  • DA-1726 signals (weight loss, glucose, waist reduction) and favorable CV profile de-risk tolerability; upcoming higher-dose data in Q4 2025 is a pivotal near-term catalyst .
  • DA-1241’s multidimensional improvements (ALT, CAP, FAST, inflammation/fibrosis biomarkers, HbA1c) strengthen its potential differentiation in MASH; EOP2 meeting in H1 2025 could frame Phase 3 path .
  • Share count increased vs prior year, and related party payable rose QoQ; monitor dilution risk and cost-sharing dynamics alongside clinical progress .
  • With no revenue and consensus estimates unavailable, trading likely hinges on clinical/newsflow timing: DA-1726 MTD cohorts (Q3/Q4 2025), DA-1241 FDA interactions, and further funding visibility .
  • Actionable: Position sizing should reflect binary trial milestones; consider catalysts calendar and runway through 2026 to balance event risk and optionality .