Welcome to our dedicated page for MetaVia SEC filings (Ticker: MTVA), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
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MetaVia Inc. (MTVA) reported positive Phase 2a results for vanoglipel (DA-1241), a GPR119 agonist being studied for MASH, with data presented at AASLD The Liver Meeting 2025 in Washington, D.C.
After 16 weeks, mean HbA1c decreased by −0.54%p with monotherapy and −0.66%p with combination therapy. From a baseline of 6.99%, patients recorded HbA1c reductions of 0.37%p, 0.41%p, and 0.54%p at weeks 4, 8, and 16 (p < 0.05 vs. placebo). Vanoglipel significantly lowered plasma ALT in participants with baseline ALT between 40–200 U/L, improved steatosis by CAP and liver stiffness by VCTE, and showed better FAST and NIS‑4 scores. Biomarkers of cell death (CK18F/M30), inflammation (hs‑CRP, CCL2), and fibrosis (TIMP1) declined, and 100 mg reduced pathogenic plasma lipids.
The treatment was well tolerated across all groups, with no treatment‑emergent adverse events leading to discontinuation reported for vanoglipel; one discontinuation occurred in the placebo group.
MetaVia Inc. launched an at-the-market offering of up to $2,300,000 of Common Stock, to be sold from time to time through Ladenburg Thalmann under a Sales Agreement as “at the market offerings” under Rule 415.
Ladenburg will act as sales agent or principal and receive a commission of up to 3.0% of the aggregate gross sales price. MetaVia intends to use any net proceeds for working capital and general corporate purposes. Under General Instruction I.B.6 of Form S-3, the company notes a public float of $2,329,870 and is limited to selling no more than one‑third of its public float in any 12‑month period while below $75 million.
Shares outstanding were 24,214,788 as of September 30, 2025. The company illustrates that, assuming sales of 2,300,000 shares at $1.00, shares outstanding could reach 26,514,788 and new investors would see illustrative dilution of $0.69 per share. The filing also highlights Nasdaq minimum bid price deficiency risk and prior stockholder approval for a potential reverse split.
MetaVia Inc. filed an 8-K stating it posted an updated corporate presentation on its investor website and furnished it as Exhibit 99.1. The presentation may be used in investor communications and conferences.
The company noted the materials contain forward-looking statements and are subject to the cautionary statements in the exhibit and in its SEC reports.
MetaVia Inc. (MTVA) reported Q3 2025 results showing a narrower net loss and lower spending while advancing its cardiometabolic pipeline. Net loss was $3.38 million on total operating expenses of $3.48 million, driven by a sharp reduction in R&D. Cash ended the quarter at $14.28 million with warrant liabilities of $0.17 million and stockholders’ equity of $6.33 million.
The company disclosed that conditions raise substantial doubt about its ability to continue as a going concern, despite stating existing cash should fund operations into 2026. MetaVia strengthened liquidity with a May 2025 private placement (net proceeds $9.1 million) and, on November 6, entered an at‑the‑market program of up to $2.3 million (3% commission) under its S‑3 shelf. Development highlights include positive Phase 2a top‑line for Vanoglipel (DA‑1241) and ongoing DA‑1726 Phase 1 multidose work, with 48 mg cohort top‑line expected in Q4 2025. As of November 5, 2025, common shares outstanding were 24,214,788.
MetaVia Inc. (MTVA) furnished an Item 2.02 Form 8-K announcing financial results for the third quarter ended September 30, 2025 and providing a corporate update. The details are contained in a press release furnished as Exhibit 99.1.
The information is furnished and not deemed "filed" under Section 18 of the Exchange Act. The company included forward-looking statements cautions. The report was signed by President and CEO Hyung Heon Kim. MetaVia’s common stock trades on Nasdaq under ticker MTVA.
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