MetaVia Inc. 8-K Filings

MetaVia Inc. reported second-quarter 2026 results and progress in its cardiometabolic pipeline, including obesity candidate DA-1726 and liver/metabolic candidate vanoglipel (DA-1241).

For the six months ended June 30, 2026, R&D expenses were approximately $5.6 million and G&A expenses were approximately $3.8 million, resulting in a net loss of approximately $9.1 million, or $1.69 per share, compared with a net loss of approximately $7.7 million a year earlier. Cash and cash equivalents were $12,634 thousand and total stockholders’ equity was $6,822 thousand as of June 30, 2026.

All active patients in both cohorts of the Phase 1 Part 3 study of DA-1726 reached the highest planned 48 mg and 64 mg dose levels, with 16-week topline data expected in the fourth quarter of 2026. Earlier Phase 1 data at 48 mg showed up to 9.1% mean weight loss after eight weeks, with reductions in waist circumference and encouraging liver-related findings. MetaVia also highlighted preclinical and clinical findings supporting vanoglipel as a potential combination backbone for metabolic and liver diseases.

MetaVia Inc. reported a key operational milestone in its obesity program. All enrolled active patients in Part 3 of its Phase 1 trial of DA-1726 have completed dose titration and are now receiving their highest target doses of 48 mg and 64 mg in the two cohorts.

Part 3 includes two 16-week titration regimens designed to test one-step and two-step dose escalation, with about 40 obese but otherwise healthy adults randomized 4:1 to active drug versus placebo. The company reiterated that topline data from this Phase 1 Part 3 study remain on track for release in the fourth quarter of 2026.

MetaVia highlighted earlier Phase 1 multiple ascending dose results where DA-1726 produced 9.1% mean weight loss at the 48 mg dose over 8 weeks, along with improvements in waist circumference, glycemic control, and early liver signals, supporting the potential of its dual GLP-1/glucagon mechanism in obesity and related metabolic disease.

MetaVia Inc. filed a Form 8-K to report a prospectus supplement tied to its existing at-the-market equity program. The company may sell up to $4,000,000 of common stock through or to Ladenburg Thalmann & Co. Inc. under a previously signed At The Market Offering Agreement.

Honigman LLP issued a legal opinion on the validity of the shares that may be issued under this arrangement, which is included as Exhibit 5.1. The filing clarifies that it is not itself an offer to sell securities and that any sales must comply with applicable state and federal securities laws.

MetaVia Inc. reported results from its virtual 2026 annual stockholder meeting. Stockholders approved a first amendment to the 2022 Equity Incentive Plan, increasing the shares available for grants by 200,000 shares of common stock while leaving all other plan terms unchanged.

All five proposals on the ballot passed. Two Class I directors were elected to terms ending at the 2029 annual meeting, stockholders ratified BDO USA, P.C. as independent auditor for the 2026 fiscal year, approved a Reverse Stock Split Proposal, the equity plan amendment, and an adjournment proposal. A total of 2,866,545 shares were present and entitled to vote, constituting a quorum.

MetaVia Inc. filed an 8-K to share new obesity and metabolic disease data presented at the ADA 2026 Scientific Sessions. Phase 1 results for once-weekly dual agonist DA-1726 showed a 6.1% mean body weight reduction at Day 26 and 9.1% at Day 54 in a 48 mg cohort, with mainly mild, transient gastrointestinal side effects and no treatment-related serious events. Waist circumference fell 9.8 cm and BMI declined 3.4 kg/m² by Day 54, supporting continued obesity development and higher-dose evaluation, with additional Phase 1 titration data expected in the fourth quarter of 2026. Preclinical studies of oral GPR119 agonist vanoglipel in combination with resmetirom or metformin demonstrated synergistic weight loss, liver-protective effects, and improved glycemic control in mouse models of MASH and type 2 diabetes, reinforcing its potential as a combination backbone.

MetaVia Inc. furnished an update on its obesity and liver-disease candidate DA-1726, sharing new Phase 1 results from a 48 mg cohort presented at EASL 2026. DA-1726 is a once-weekly dual GLP1R/GCGR agonist being developed for obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH).

In obese but otherwise healthy adults, once-weekly 48 mg DA-1726 without dose titration was generally well tolerated, with no serious adverse events, no treatment-related discontinuations and mainly mild-to-moderate, transient gastrointestinal side effects. No clinically meaningful changes in cardiovascular measures, including heart rate and QTcF, were seen despite glucagon receptor activation.

Participants on 48 mg DA-1726 achieved a mean body-weight reduction of 6.1% at Day 26 and 9.1% at Day 54, along with notable waist reductions. Exploratory FibroScan measures showed early, noninvasive signals of liver-related improvement versus placebo, supporting further evaluation of DA-1726 in obesity and MASH as ongoing Phase 1 titration studies continue.

MetaVia Inc. announced that three late-breaking abstracts on its cardiometabolic drug candidates DA-1726 and vanoglipel have been accepted for poster presentations at the American Diabetes Association’s 2026 Scientific Sessions in New Orleans from June 5–8, 2026.

DA-1726 is a once-weekly injectable dual GLP1R/GCGR agonist being studied for obesity and MASH. It is currently in a 16-week Phase 1 Part 3 titration study, following a Phase 1 multiple ascending dose trial where a 32 mg dose showed strong effects on weight, glucose, and waist circumference.

Vanoglipel is a GPR119 agonist in development for MASH and type 2 diabetes. Preclinical models showed improvements in liver fat, inflammation, fibrosis, and glucose control, and Phase 1a, 1b and 2a trials reported that vanoglipel was well tolerated with evidence of direct hepatic action and glucose lowering.

MetaVia Inc. reported first quarter 2026 results and highlighted progress for its obesity candidate DA-1726. In a Phase 1 8-week, non-titrated 48 mg cohort, DA-1726 achieved 9.1% weight loss with improved glucose control, waist reduction and liver benefit, with a favorable safety profile.

The company has dosed the first patient in Part 3 of its Phase 1 trial using 48 mg and 64 mg titration regimens, with data expected in the fourth quarter of 2026. For the quarter ended March 31, 2026, MetaVia reported a net loss of $3,823,000 versus $3,671,000 a year ago, and basic and diluted loss per share of $0.79 versus $3.93, reflecting a higher share count.

Cash and cash equivalents were $13,731,000 as of March 31, 2026 compared with $10,278,000 at year-end 2025, and stockholders’ equity increased to $9,073,000 from $5,333,000. The 8-K furnishes the earnings press release and an updated corporate presentation, which include additional clinical and financial details.

MetaVia Inc. furnished an update highlighting progress for its obesity drug candidate DA-1726. A late-breaking abstract on DA-1726, a dual oxyntomodulin analog targeting GLP-1 and glucagon receptors, has been accepted for a poster presentation at the EASL Congress 2026 in Barcelona.

The company notes DA-1726 is being evaluated in a 16-week Phase 1 Part 3 titration study aimed at optimizing higher dose levels and tolerability, with data expected in the fourth quarter of the year. Prior Phase 1 multiple ascending dose results in obesity showed best-in-class potential for weight loss, glucose control, and waist reduction compared to existing GLP-1 therapies in pre-clinical and early clinical work.

MetaVia Inc. has dosed the first patient in Part 3 of its Phase 1 trial of DA-1726, a dual GLP-1/glucagon agonist for obesity. This higher-dose study runs over 16 weeks and compares one-step titration to 48 mg with a two-step regimen reaching 64 mg in obese, otherwise healthy adults.

The company highlights earlier Phase 1 data showing approximately 9% weight loss at a 48 mg dose, with reductions in waist circumference, improved glycemic control, and early signs of liver benefit, alongside a favorable tolerability profile. Part 3 is designed to test whether higher therapeutic doses can be reached more quickly while maintaining tolerability, with data expected in the fourth quarter of 2026.

MetaVia Inc. filed a current report to let investors know it has posted an updated corporate presentation dated March 2026 on its investor relations website. The same presentation is attached as Exhibit 99.1 and may be used in future presentations, investor communications, or conferences.

The information in this report, including Exhibit 99.1, is furnished under Regulation FD and is not deemed filed for liability purposes under securities laws, unless specifically incorporated by reference elsewhere. The presentation contains forward-looking statements that are subject to important limitations and risk factors described in the company’s SEC reports.

MetaVia Inc. reported full-year 2025 results and a cardiometabolic pipeline update. Cash and cash equivalents were $10.3 million at year-end, and a January 2026 public offering raised $9.3 million, which together are expected to fund operations into the fourth quarter of 2026.

For 2025, MetaVia posted a net loss of $12.97 million, improving from a $27.59 million loss in 2024, as research and development expenses fell to $6.80 million from $21.55 million. Loss per share narrowed to $(7.35) from $(39.13), with 1.77 million weighted-average shares outstanding.

Lead obesity candidate DA-1726 showed 9.1% weight loss with improved glucose control and liver measures in a Phase 1 48 mg cohort, and is backed by 39 granted and pending patents with protection at least through 2041. A 16-week titration Phase 1 Part 3 study at 48 mg and 64 mg has IRB approval, with dosing expected to begin in April 2026 and data anticipated in the fourth quarter of 2026.

MetaVia Inc. filed an 8-K to report that an Institutional Review Board at Clinical Pharmacology of Miami has approved Phase 1 Part 3 of its obesity trial for lead drug DA-1726, a dual GLP-1 and glucagon receptor agonist. The 16-week study will enroll 40 obese but otherwise healthy adults in two cohorts, testing one-step titration up to 48 mg and two-step titration up to 64 mg. It will track safety, side effects, pharmacokinetics, and multiple metabolic and body composition measures. MetaVia plans to begin dosing in April 2026 and expects data in the fourth quarter of 2026, building on earlier Phase 1 results where the 48 mg dose produced about 9% weight loss and improved glucose and waist measures.

MetaVia Inc. filed an 8-K to disclose final 2025 cash bonuses for its top executives and to update its “Summary Compensation Table for 2025 and 2024.” The Compensation Committee approved discretionary cash bonuses for the company’s principal executive officer and other named executive officers for the fiscal year ended December 31, 2025.

For 2025, President and Chief Executive Officer Hyung Heon Kim received salary of $479,723, a bonus of $239,862, and total compensation of $756,328. Chief Financial Officer Marshall H. Woodworth received salary of $393,300, a bonus of $157,320, and total compensation of $562,985. For 2025, “All Other Compensation” for the named executives was related to health and welfare benefits paid by MetaVia.

MetaVia Inc. completed an underwritten public offering of Class A and Class B units, raising approximately $7.7 million in net proceeds. The company sold 1,006,870 Class A Units, each with one common share plus Series C and Series D common warrants, and 1,998,704 Class B Units, each with a pre-funded warrant plus additional Series C and Series D warrants. The Series C and Series D warrants are immediately exercisable at $3.10 per share, with the Series C warrants expiring five years after January 16, 2026 and the Series D warrants expiring two years after that date.

MetaVia plans to use the net proceeds for working capital and general corporate purposes, including continuing clinical development of its obesity candidate DA-1726. The underwriter received a 45-day over-allotment option for additional shares and warrants, which was fully exercised, and company executives and directors agreed to a 75-day lock-up on sales of company securities following the offering’s closing.

MetaVia Inc. (MTVA) reports that Nasdaq has granted the company a 180‑day extension, until May 26, 2026, to regain compliance with Nasdaq’s minimum bid price requirement, which calls for a closing bid of at least $1.00 per share for 10 consecutive business days. The extension follows an earlier notice that MetaVia’s stock had traded below $1.00 for 30 straight trading days.

MetaVia noted it had more than $5 million in stockholders’ equity as of September 30, 2025 and already has shareholder approval to implement a reverse stock split at a ratio between 1‑for‑5 and 1‑for‑30 at the board’s discretion. The company plans to monitor its share price and may use a reverse split to help restore compliance. If it does not regain compliance by the new deadline, its shares could be subject to delisting from Nasdaq, though the company would be able to appeal.

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. 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) 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.