MetaVia — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total operating expenses were $4.7 million for the quarter ended September 30, 2026, compared to $3.5 million in the same period in 2025.
• Research and development (R&D) expenses were $2.6 million for the quarter, up from $1.9 million in 2025, driven by higher direct R&D costs for DA-1726.
• General and administrative (G&A) expenses were $2.1 million for the quarter, up from $1.6 million in 2025, due to increased legal fees, consulting, and compensation.
• Net loss was $4.6 million ($0.69 per share) for the quarter, compared to a net loss of $3.4 million ($1.52 per share) in 2025.
• For the nine months ended September 30, 2026, total operating expenses were $14.1 million versus $11.7 million in 2025.
• Net loss for the nine months ended September 30, 2026, was $13.8 million ($2.36 per share), compared to $11.0 million ($6.93 per share) in 2025.
• Cash and cash equivalents were $8.8 million as of September 30, 2026, down from $10.3 million as of December 31, 2025.
• Total other income was $0.1 million for the quarter, unchanged from 2025; for the nine months, it decreased to $0.3 million from $0.6 million in 2025 due to lower interest income and warrant liability gains.
• Weighted average shares outstanding increased to 6,679,250 in the quarter from 2,219,625 in 2025.

Guidance and Future Outlook:

• Full data from Phase 1 Parts 3A and 3B for DA-1726 is expected in the first quarter of 2027.
• A 48-week Phase 2 study for DA-1726 in MetALD and ALD is targeted to begin in the second half of 2027.
• A Phase 2a proof-of-concept study for vanoglipel in combination with resmetirom for MASH is targeted to begin in the first half of 2027.
• MetaVia plans to schedule an End-of-Phase 2 meeting with the FDA before the end of 2026 to discuss the clinical development pathway for vanoglipel.

Business Segments and Product Lines:

• DA-1726 (oxyntomodulin analog) demonstrated a 68.1% placebo-adjusted reduction in liver fat and 13.5% placebo-adjusted weight loss after 16 weeks in Phase 1 Part 3B.
• All five participants with baseline steatosis in the DA-1726 Phase 1 Part 3B study achieved MRI-PDFF below 5%.
• DA-1726 showed a statistically significant 1.47 mg/dL placebo-adjusted reduction in uric acid after 16 weeks.
• DA-1726 achieved dose titration completion in the 16-week Phase 1 Part 3 study, with all active patients reaching the highest planned doses of 48 mg and 64 mg.
• Vanoglipel (DA-1241) is being advanced in combination with resmetirom for MASH, with a Phase 2a study targeting the first half of 2027.
• Preclinical data presented at ObesityWeek 2026 indicated DA-1726 demonstrated comparable weight loss and a distinct metabolic profile compared with Retatrutide.

Market and Competitive Landscape:

• The company highlighted the significant unmet medical need in treating metabolic dysfunction and alcohol-associated liver disease (MetALD) and alcohol-associated liver disease (ALD).
• MetaVia hosted an invitation-only Key Opinion Leader (KOL) dinner during AASLD's The Liver Meeting 2026 to discuss the evolving treatment landscape in MetALD.

Risks and Challenges:

• The company faces risks related to its history of net losses and the sufficiency of existing cash on hand to fund operations.
• Risks include the ability to raise additional capital, adverse global economic conditions, and the timeline for regulatory submissions.
• Potential risks involve the ability to obtain regulatory approval, execute commercial strategy, and complete clinical trials on a timely basis.
• The company notes risks associated with the license agreement with Dong-A ST Co., Ltd., including potential litigation or regulatory action costs.

Management Commentary and Tone:

• CEO Hyung Heon Kim stated that interim results provide important clinical support for DA-1726's potential to treat MetALD and ALD.
• The company appointed Sarah Browne, M.D., as Chief Medical Officer in October 2026 to lead clinical development, citing her experience in developing pemvidutide through Phase 2 and establishing Phase 3 strategies.
• Management expressed confidence in the liver-focused cardiometabolic profile of DA-1726, noting the preservation of lean tissue alongside fat and weight reduction.

Other Key Points:

• MetaVia reported a significant increase in weighted average shares outstanding from 2.2 million in Q3 2025 to 6.7 million in Q3 2026.
• Clinical trial accrued liabilities increased to $1.6 million as of September 30, 2026, from $79,000 as of December 31, 2025.
• Related party payables decreased to $2.1 million as of September 30, 2026, from $3.3 million as of December 31, 2025.
• Warrant liabilities decreased to $25,000 as of September 30, 2026, from $136,000 as of December 31, 2025.
• The company has 6,742,889 shares issued and outstanding as of September 30, 2026, compared to 2,308,294 as of December 31, 2025.