MetaVia Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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Item 7.01. Regulation FD Disclosures.
On March 18, 2026, MetaVia Inc. (the “Company”) issued a press release announcing that the Institutional Review Board at Clinical Pharmacology of Miami has approved the Company’s Phase 1 Part 3 clinical trial of its lead asset, DA-1726, a novel, dual oxyntomodulin analog agonist targeting both GLP-1 and glucagon receptors. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”) and is incorporated herein by reference.
Information contained on or accessible through any website reference in the press release is not part of, or incorporated by reference in, this Report, and the inclusion of such website addresses in this Report by incorporation by reference of the press release is as inactive textual references only.
The information in Item 7.01 of this Report, including Exhibit 99.1 attached hereto, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. The Company’s submission of this Report shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.
Item 8.01. Other Events.
On March 18, 2026, the Company issued a press release announcing that the Institutional Review Board at Clinical Pharmacology of Miami has approved the Company’s Phase 1 Part 3 clinical trial of its lead asset, DA-1726, a novel, dual oxyntomodulin analog agonist targeting both GLP-1 and glucagon receptors. The Phase 1 Part 3 trial will enroll a total of 40 obese, otherwise healthy adult subjects, across two parts, with 20 subjects per part, randomized 4:1 (16 active; 4 placebo). Part 3A is designed to evaluate a one-step titration regimen with 16 mg for 4 weeks followed by 48 mg for 12 weeks, while Part 3B will evaluate a two-step titration regimen with 16 mg for 4 weeks, 32 mg for 4 weeks, and 64 mg for 8 weeks. The study will assess safety, tolerability, pharmacokinetics (“PK”), and pharmacodynamics of DA-1726. Primary endpoints include monitoring adverse events (“AEs”), serious adverse events, treatment-emergent adverse events, and AEs leading to treatment discontinuation. Secondary and exploratory endpoints include PK profiling and evaluation of metabolic, glycemic, lipid, and body composition measures, including weight, waist circumference, and body mass index, and other cardiometabolic measures. The Company plans to initiate initial dosing in April 2026, with data expected in the fourth quarter of 2026.
Forward-Looking Statements
This Report, including Exhibit 99.1 attached hereto, contains forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are based on current expectations and are not guarantees of future performance. Further the forward-looking statements are subject to the limitations listed in Exhibit 99.1 and in the other reports of the Company filed with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit |
| Exhibit Description |
99.1 | ||
104 | Cover Page Interactive Data File (embedded within Inline XBRL document). |
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| METAVIA INC. | ||
Date: March 18, 2026 | By: | /s/ Hyung Heon Kim | |
Hyung Heon Kim | |||
President and Chief Executive Officer | |||