MetaVia Inc. (MTVA)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 delivered disciplined expense control: R&D fell to $1.914M and G&A to $1.561M, driving Total Operating Expenses down 44% year over year to $3.475M and narrowing net loss to $3.377M ($0.14 per share) .
• Cash ended at $14.3M, and management reiterated runway into 2026; dilution from warrant exercises increased weighted average shares, further lowering per-share loss versus 2024 .
• Clinical catalysts strengthened the narrative: DA-1726 Phase 1 PK supports once‑weekly dosing; an 8‑week 48 mg MAD cohort is underway with top-line data expected by year‑end 2025; vanoglipel (DA‑1241) presented positive 16‑week Phase 2a data at AASLD .
• Guidance/timing shift: MetaVia now targets an End‑of‑Phase‑2 FDA meeting for vanoglipel in 1H26 (vs. 1H25 in Q1) — a notable schedule delay to monitor .
• Near-term stock catalysts: DA‑1726 48 mg 8‑week readout (year‑end 2025) and continued visibility from AASLD/ObesityWeek data may drive sentiment; funding visibility into 2026 reduces near‑term financing overhang if timelines hold .

What Went Well and What Went Wrong

What Went Well

• DA‑1726 Phase 1 results reinforced best‑in‑class potential: linear, dose‑proportional exposure with ~80‑hour half‑life supporting once‑weekly dosing; 32 mg cohort achieved up to 6.3% weight loss and up to 3.9 inches waist reduction, sustained for two weeks post‑dosing .
• Expense discipline: R&D and G&A declined meaningfully YoY, compressing Total Operating Expenses and narrowing net loss per share to $0.14 .
• Management tone remained confident: “continued to make strong progress” advancing cardiometabolic portfolio; DA‑1726 viewed as “differentiated dual oxyntomodulin (OXM) analog agonist,” with 48 mg 8‑week cohort readout targeted by year‑end 2025 .

What Went Wrong

• Regulatory timing slippage: vanoglipel End‑of‑Phase‑2 FDA meeting shifted from 1H25 (Q1) to 1H26, extending the path to pivotal development and potential commercialization .
• Lower other income YoY reduced the non‑operating offset: total other income fell to $0.098M vs. $0.607M in Q3 2024, driven by lower interest income and warrant liability fair‑value change .
• Rising related‑party payables and continued pre‑revenue status underscore funding/execution risk beyond 2026 if timelines extend; cash declined from $17.6M in Q2 to $14.3M in Q3 .

Financial Results

Notes:

• MetaVia is pre‑revenue; Statements of Operations present operating expenses and other income without revenue recognition in the quarter .
• Cash runway into 2026 reiterated across quarters .

KPIs (Clinical and Program)

Guidance Changes

Earnings Call Themes & Trends

Note: An earnings call transcript for Q3 2025 was not available in the document set searched (earnings‑call‑transcript/other‑transcript returned no results) [ListDocuments results].

Management Commentary

• “During the third quarter and subsequently, we continued to make strong progress advancing our next‑generation cardiometabolic portfolio, highlighted by the Phase 1 data for DA‑1726 presented just recently at ObesityWeek 2025.” — Hyung Heon Kim, CEO .
• “Newly reported pharmacokinetic (PK) data showed linear, dose‑proportional exposure and an approximately 80‑hour half‑life, supporting the feasibility of once‑weekly dosing.” .
• “We expect to report results from [the 8‑week, 48 mg cohort] by year‑end, which will help inform the next stage of development and further demonstrate DA‑1726’s potential as a best‑in‑class treatment for obesity.” .
• “Vanoglipel (DA‑1241) ... demonstrated meaningful reductions in liver fat, inflammation and fibrosis... [and] dual anti‑inflammatory and anti‑fibrotic mechanisms...” .

Q&A Highlights

• No Q3 2025 earnings call transcript was found; therefore, Q&A themes and guidance clarifications are unavailable from primary sources (search returned no earnings‑call‑transcript/other‑transcript for MTVA in Oct–Nov 2025) [ListDocuments results].

Estimates Context

• S&P Global consensus estimates for Q3 2025 (EPS and Revenue) were unavailable via tool retrieval; MetaVia is a clinical‑stage, pre‑revenue biotech, so investor focus centers on OpEx, cash runway, and clinical timelines rather than quarterly revenue/EPS comparisons [GetEstimates result].
• Given the lack of consensus data, no beat/miss assessment versus Wall Street estimates can be made for Q3 2025 at this time.

Key Takeaways for Investors

• Expense control is a clear focus: OpEx declined to $3.475M, helping narrow net loss to $3.377M and loss per share to $0.14; monitor if this cadence sustains as clinical programs scale .
• Cash runway into 2026 provides near‑term operational flexibility; watch cash trajectory and any incremental financing needs tied to EoP2/pivotal planning .
• DA‑1726 has emerging differentiation: once‑weekly PK, non‑titrated dosing at 32 mg with clinically meaningful weight and waist reductions — a favorable tolerability profile vs. some GLP‑1s is a potential commercial angle if efficacy scales at 48 mg over 8 weeks .
• Vanoglipel’s multi‑pathway impact (glycemic, hepatic, lipidomic) is promising; however, the EoP2 timing delay to 1H26 introduces a longer path to pivotal studies and potential value inflection .
• Near‑term trading setup: year‑end DA‑1726 48 mg 8‑week readout is the primary catalyst; strong efficacy/tolerability could drive upside sentiment, while mixed results may weigh on the stock .
• Medium‑term thesis hinges on execution in obesity and MASH: scale-up risks, regulatory timelines, and capital needs beyond 2026 should be underwritten in position sizing and risk management .
• Continue monitoring partner/AI updates (Syntekabio) for optionality around DA‑1241 indications and differentiation pathways .