MetaVia Inc.

**1.**Business, basis of presentation, new accounting standards and summary of significant accounting policies

General

MetaVia Inc. (the “Company”), a Delaware corporation, and its subsidiaries are referred to collectively in these notes to the financial statements of the Company as “MetaVia,” “we,” “our” and “us.” We are a clinical-stage biotechnology company focused primarily on developing novel pharmaceuticals to treat cardiometabolic diseases. We have two programs, vanoglipel and DA-1726, focused primarily on the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and obesity.

While we focus our financial resources and management’s attention on the development of vanoglipel and DA-1726, we also have four legacy therapeutic programs designed to impact a range of indications in viral, neurodegenerative and cardiometabolic diseases which we are not planning to advance development on and have, or continue to consider for, out-licensing and divestiture opportunities. In July 2024, we entered into an exclusive out-license agreement with MThera Pharma Co., LTD. (“MThera”) to provide MThera with the rights to one of our legacy therapeutic programs, NB-01, for the treatment of painful diabetic neuropathy.

Our operations consist principally of performing research and development (“R&D”) activities, which include preclinical development and clinical trials, and raising capital. Our activities are subject to significant risks and uncertainties, including failing to secure additional funding before sustainable revenues and profit from operations are achieved.

Going concern

As reflected in the condensed consolidated financial statements, we had$12.6 million in cash and cash equivalents as of June 30, 2026. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of$158.0 million as of June 30, 2026. We have incurred a net loss of$9.1 million and net cash used in operating activities of$8.0 million for the six months ended June 30, 2026. Due in large part to ongoing clinical trials, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern within one year from the issuance of these condensed consolidated financial statements.

We plan to continue to fund our operations through equity offerings, debt financing, the exercise of existing warrants, or other sources, potentially including collaborations, out-licensing and other similar arrangements. However, there can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all, or that the warrants issued in previously consummated offerings will be exercised. To the extent that we can raise additional funds by issuing equity securities or in the event our remaining warrants are exercised, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct our business. If we are unable to raise additional capital, we may slow down or stop our ongoing and planned clinical trials until such time as additional capital is raised and this may have a material adverse effect on the Company.

The determination as to whether we can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Our condensed consolidated financial statements have been prepared assuming that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities in the normal course of business.

**A.**Basis of presentation

We prepared the condensed consolidated financial statements following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“GAAP”) for complete financial statements can be condensed or omitted. However, except as disclosed herein, there has been no material change in the information disclosed in the notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (“2025 Form 10-K”).

Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these condensed consolidated financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the condensed consolidated financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in the condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in our 2025 Form 10-K. Certain amounts in the condensed consolidated financial statements and accompanying notes may not add up due to rounding, and all percentages have been calculated using unrounded amounts.

**B.**New accounting standards

Adoption of new accounting standards

New accounting standards or accounting standards updates were assessed and determined to be either not applicable or did not have a material impact on our consolidated financial statements or processes.

Accounting standards issued but not yet adopted

In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses to improve financial reporting by requiring that public business entities disclose additional information about specific expense categories in the notes to the consolidated financial statements at interim and annual reporting periods. The amendments in this ASU do not change or remove current expense disclosure requirements; however, the amendments affect where such information appears in the notes to the consolidated financial statements because entities are required to include certain current disclosures in the same tabular format disclosure as the other disaggregation requirements in the amendments. In January 2025, the FASB issued ASU 2025-01, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. This ASU is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods within annual reporting period beginning after December 15, 2027. Early adoption is permitted. We continue to evaluate the impact of adopting this ASU to our notes to the consolidated financial statements and processes.

Other recently issued accounting standards not yet adopted by us are not expected, upon adoption, to have a material impact on our consolidated financial statements.

**C.**Estimates and assumptions

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in our condensed consolidated financial statements relate to clinical trial costs and accruals, classification of warrants as derivative liability or equity, and the fair value of stock-based compensation and warrants. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.

**D.**Significant accounting policies

Our significant accounting policies are described in “Note 1. Business, basis of presentation, new accounting standards and summary of significant accounting policies” in the audited consolidated financial statements and notes thereto for the year ended December 31, 2025, which is included in our 2025 Form 10-K. Except for the following disclosure, there have been no material changes to our significant accounting policies.

Financial Instruments with Characteristics of Both Liabilities and Equity

We account for issued warrants either as a liability or equity in accordance with Accounting Standard Codification (“ASC”) 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, and ASC 815-40,

Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock. Under ASC 480-10, warrants are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number of shares. If warrants do not meet liability classification under ASC 480-10, we consider the requirements of ASC 815-40 to determine whether the warrants should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in other expense, net in the consolidated statements of operations as a gain or loss. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, we assess whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or under another applicable GAAP standard. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date.

**2.**Prepaid expenses and other current assets

Prepaid expenses and other current assets consist of the following (in thousands):

**3.**Property and equipment, net

Property and equipment, net consist of the following(in thousands):

We recorded depreciation expense, which was included in G&A operating expenses in the accompanying condensed consolidated statements of operations, of $4 thousand and $9 thousand for the three and six months ended June 30, 2026, respectively, and $5 thousand and $9 thousand for the three and six months ended June 30, 2025, respectively.

**4.**Current liabilities

Clinical trial accrued liabilities

Clinical trial accrued liabilities was $2.8 million as of June 30, 2026 as compared to $0.1 million as of December 31, 2025. The increase of $2.7 million was due to timing of when the third-party clinical research organization (“CRO”) invoices us for services performed by the CRO. Additionally, the overall increase in clinical trial accrued liabilities reflects increased R&D activities in 2026 related to the Phase 1 clinical trial for DA-1726.

Accrued expenses and other current liabilities

Accrued expenses and other current liabilities consist of the following(in thousands):

Warrant liabilities

Changes to our warrant liabilities are summarized as follows (in thousands):

Our warrant liabilities relate to the 2022 Series B warrants, which were issued in November 2022. These warrants are considered to be derivative instruments; accordingly, we recorded their estimated fair value as warrant liabilities. We estimated the fair value of these warrants using the trading market price of our common stock due to a cashless exercise provision of these warrants whereby eight warrants can be exercised for one share of common stock forno additional consideration, which results in an effective per warrant exercise price ofzero.

5**.**Related party

We entered into a license agreement with Dong-A ST Co., Ltd. (“Dong-A ST”) pursuant to which we received an exclusive global license (except for the territory of the Republic of Korea) for two proprietary compounds for specified indications (the “2022 License Agreement”) upon meeting certain financing milestones. The 2022 License Agreement covers the rights to vanoglipel for treatment of MASH and DA-1726 for treatment of obesity and MASH. The 2022 License Agreement also provides that we may develop vanoglipel for the treatment oftype 2 diabetes mellitus.

In connection with the 2022 License Agreement, we entered into a shared services agreement with Dong-A ST (the “Shared Services Agreement”), relating to vanoglipel and DA-1726, pursuant to which Dong-A ST may provide technical support, preclinical development, and clinical trial support services on terms and conditions acceptable to both parties. In addition, the Shared Services Agreement provides that Dong-A ST will manufacture all of our clinical requirements of vanoglipel and DA-1726 under the terms provided in the Shared Services Agreement.

We incurred R&D expenses of$0.2 million and$0.9 million for the three and six months ended June 30, 2026, respectively, and$1.3 million and$2.4 million for the three and six months ended June 30, 2025, respectively, under the Shared Services Agreement, which are included in R&D operating expenses in the accompanying condensed consolidated statements of operations. Theaggregate amount payable to Dong-A ST was$1.9 million and$3.3 million as of June 30, 2026 and December 31, 2025, respectively, under the Shared Services Agreement, which are included in related party payable in the accompanying condensed consolidated balance sheets. Of the total amount payable to Dong-A ST as of June 30, 2026 (i)$1.4 million is payable in accordance with an invoice with extended terms in which approximately$0.7 million was due on June 30, 2026 and$0.7 million is due on September 30, 2026, (ii)$0.1 million is payable in accrued interest based on a fixed interest rate of 4.6% per annum, and (iii)$0.4 million is payable in clinical trial accrued liabilities. The amounts due on June 30, 2026 remains unpaid as of the date of issuance of these condensed consolidated financial statementsand have been included in current liabilities.

For additional information on the 2022 License Agreement, the Shared Services Agreement and other agreements with Dong-A ST, refer to “Note 5. Related party” in the audited consolidated financial statements and notes thereto for the year ended December 31, 2025, which is included in our 2025 Form 10-K.

**y****6.**Commitments and contingencies

Contingent payments and license agreements

We have certain contractual contingent payments under various merger or license agreements executed between 2019 and 2020 for our legacy therapeutic programs. Since we have discontinued the clinical development of our legacy therapeutic programs, we believe anycontractual payments to be paid by us or to be received by us under these agreements are remote. Therefore, as of June 30, 2026, no liabilities orassets were recorded in the accompanying consolidated financial statements for our legacy therapeutic programs.

Legal proceedings

From time to time, we may be involved in various claims and legal proceedings arising out of our ordinary course of business. We are not currently a party to any claims or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business and consolidated financial statements. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

**7.**Stockholders’ equity

Public offering

In January 2026, we closed on an underwritten public offering and received net proceeds of $7.1 million, pursuant to which we issued and sold, (i)1,006,870 Class A Units, with each Class A Unit consisting of (A)one share of common stock, (B)1.5 Series C Common Warrants to purchase 1.5 shares of common stock, and (C)1.5 Series D Common Warrants to purchase 1.5 shares of common stock, at a price of $3.10 per Class A Unit, and (ii)1,998,704 Class B Units, with each Class B Unit consisting of (A)one pre-funded warrant to purchaseone share of common stock, (B)1.5 Series C Common Warrants to purchase 1.5 shares of common stock, and (C)1.5 Series D Common Warrants to purchase 1.5 shares of common stock, at a purchase price of $3.099 per Class B Unit.

Each pre-funded warrant has an exercise price of$0.001 per share and is immediately exercisable and will expire when exercised in full. Each Series C Common Warrant and Series D Common Warrant has an exercise price of$3.10 per whole share of common stock, subject to certain adjustments, are immediately exercisable, and will expire on January 16, 2031 and January 16, 2028, respectively. Under the Series C Common Warrant and the Series D Common Warrant, we may not affect the exercise of any such warrants, and a holder will not be entitled to exercise any portion of any such warrants, which, upon giving effect to such exercise, would cause the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates) to exceed the beneficial ownership limitation contained therein. The Series D Common Warrants are callable at our option following the release of a positive data readout for our Phase 1, Part 3 clinical trial for DA-1726 via a widely disseminated press release, subject to the satisfaction of certain conditions. The Series C and Series D Common Warrants are fixed priced and do not contain any variable pricing features or alternative exercise provisions. Based on the terms of the pre-funded warrants, the Series C Common Warrants and Series D Common Warrants, we have concluded that the accounting classification of these warrants is to be stockholders’ equity.

The following table provides information on the warrants exercised during the three and six months ended June 30, 2026:

At the market offering

In November 2025, we entered into an At The Market Offering Agreement (the “ATM Sales Agreement”) with Ladenburg Thalmann & Co. Inc., as sales agent and/or principal (“Ladenburg”), pursuant to which we could offer and sell, from time to time through or to Ladenburg, shares of our common stock having an aggregate offering price of up to $2.3 million (the “ATM Program”) through June 30, 2026. The offer and sale of the shares of common stock pursuant to the ATM Program through June 30, 2026 was made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-278646) filed with the SEC on April 12, 2024, and declared effective by the SEC on April 23, 2024, as supplemented by a prospectus supplement filed with the SEC on November 6, 2025 pursuant to Rule 424(b) under the Securities Act.

Pursuant to the ATM Sales Agreement, Ladenburg may sell the shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act. We are not obligated to make any sales of the shares under the ATM Sales Agreement. The offering of shares pursuant to the ATM Sales Agreement will terminate upon the termination of the ATM Sales Agreement by Ladenburg or us, as permitted therein. We are obligated to pay Ladenburg an aggregate sales agent commission of 3.0% of the gross sales price of the shares sold pursuant to the ATM Sales Agreement. We will also reimburse Ladenburg for certain specified expenses in connection with entering into the ATM Sales Agreement, which contains customary representations and warranties and conditions to the placements of the shares pursuant thereto.

In 2026, we sold 422,919 shares of common stock under the ATM Program and received net proceeds of $0.7 million, net of sales agent commission and related offering expenses. As of June 30, 2026, we had $0.2 million remaining under the ATM Program in which we may offer and sell shares of our common stock. On July 2, 2026, we increased the size of the ATM Program to allow the offer and sale of shares of our common stock having an aggregate offering price of up to $4.0 million.

Private placement

In May 2025, we closed on a private placement offering with Dong-A ST and Dong-A Socio Holdings Co., Ltd., an affiliate company of Dong-A ST, and received net proceeds of $9.1 million, net of placement agent cash fees of $0.4 million and related offering expenses of $0.5 million. The private placement offering was comprised of (i)861,758 shares of our common stock for a purchase price of $7.81 per share, and (ii)418,651 pre-funded warrants to purchase up to an equivalent number of shares of our common stock for a purchase price of $7.799 per pre-funded warrant.

Each pre-funded warrant had an exercise price of $0.011 per share, and was exercisable beginning on June 30, 2025, which was the effective date of receiving stockholder approval for the issuance of the shares of common stock underlying the pre-funded warrants. Thereafter, on the same date, all pre-funded warrants were exercised for an equivalent number of shares of our common stock.

Common stock issued for professional services

In May 2026, we issued 50,000 shares of common stock based on a closing price of $2.89 per share on the date of issuance to a vendor for business advisory services provided by the vendor. Accordingly, we recorded an expense of approximately $0.1 million during the three and six months ended June 30, 2026, which was included in G&A operating expenses.

Warrants

The following table summarizes our outstanding warrants:

(1)These warrants have a cashless exercise provision whereby the warrants can be exercised for common stock forno additional consideration, which renders the$264.00 per warrant exercise price to bezero.

(2)These warrants expire on the earlier of September 18, 2029 and thesix months anniversary following the date on which we publicly announce a positive data readout for our Phase 1, Part 3 clinical trial for DA-1726.

(3)These warrants are callable at our option following the release of a positive data readout for our Phase 1, Part 3 clinical trial for DA-1726 via a widely disseminated press release, subject to the satisfaction of certain conditions.

Stock-based compensation

Stock-based award plans

Our Amended and Restated 2022 Equity Incentive Plan (the “2022 Plan”) provides for an automatic increase on January 1st of each year for a period ofeight years commencing on January 1, 2025 and ending on (and including) January 1, 2032, of the aggregate number of shares of common stock that may be issued pursuant to Awards (as defined in the 2022 Plan) to an amount equal to 10% of the Fully Diluted Shares (as defined in the 2022 Plan) as of the last day of the preceding calendar year. Accordingly, in January 2026, the 2022 Plan automatically increased the aggregate number of shares of common stock that may be issued pursuant to Awards by 94,236 shares.

In June 2026, at our 2026 virtual annual meeting of stockholders, the Company’s stockholders approved the first amendment to the 2022 Plan (the “First Amendment”), which was previously approved by the Board of Directors of the Company. The First Amendment became effective upon stockholder approval, and provides for an increase in the aggregate number of shares of our common stock that may be issued pursuant to the 2022 Plan by 200,000 shares. Except as amended by the First Amendment, the other terms of the 2022 Plan remain in full force and effect.

The following table summarizes the outstanding awards issued pursuant to our stock-based award plans and inducement plan as of June 30, 2026 and the remaining shares of common stock available for future issuance:

Restricted Stock Units

The following table summarizes the status of our outstanding restricted stock units (“RSUs”) and related transactions for the period presented, as well as our vested and deferred release RSUs as of January 1, 2026 and June 30, 2026 (in thousands, except share and per share amounts):

Stock-based compensation expense

Stock-based compensation expense was included in operating expenses as follows(in thousands):

For stock-based awards granted under our stock-based award plans as of June 30, 2026, unrecognized stock-based compensation costs totaled $0.6 million. The unrecognized stock-based costs are expected to be recognized as an expense over a weighted average period of 1.2 years.

8**.**Significant segment expenses and loss before income taxes

We manage and operate asone reportable segment, which is principally the business of development of pharmaceutical products, with one geographic location in the U.S. We do not operate separate lines of business with respect to each pharmaceutical product being studied. Our Chief Operating Decision Maker (“CODM”) is our chief executive officer. The CODM manages the Company’s operations on a consolidated basis for the purpose of allocating resources. The measure of performance used by the CODM to assess segment performance is reported on the consolidated statements of operations as loss from operations and net loss. Since the Company only hasone reportable segment, our CODM does not need to decide on how to allocate resources between segments. The measure of segment assets is reported on the consolidated balance sheets as total assets.

The following table sets forth the significant segment expenses for ourone reportable segment (in thousands):

(1)Other R&D expenses include clinical, non-clinical and preclinical services and other R&D expenditures that are not attributable to a single product candidate.

(2)Other G&A expenses include insurance, software license fees, non-income state taxes, lease rental expenses and other G&A expenditures.

9**.**Income taxes

We do not expect to pay any significant federal or state income taxes as a result of (i) the losses recorded during the three and six months ended June 30, 2026, (ii) additional losses expected for the remainder of 2026, or (iii) net operating loss carry forwards from prior years.

We recorded a full valuation allowance of the net operating losses for the three and six months ended June 30, 2026 and 2025. Accordingly, there wereno benefits for income taxes recorded for the three and six months ended June 30, 2026 and 2025. Additionally, as of June 30, 2026 and December 31, 2025, we maintain a full valuation allowance for all deferred tax assets.

**10.**Loss per share of common stock

The following table sets forth the computation of basic and diluted loss per share of common stock(in thousands, except share and per share amounts):

For each of the periods presented in the above table, our basic weighted average shares of common stock include any outstanding (i) Series B warrants issued in November 2022, (ii) pre-funded warrants issued in June 2024, May 2025 and January 2026 and (iii) vested RSUs in which their release were deferred.

Since we reported a net loss for the three and six months ended June 30, 2026 and 2025, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities. Therefore, our basic and diluted loss per share of common stock and our basic and diluted weighted average shares of common stock are the same for the three and six months ended June 30, 2026 and 2025.

The following table sets forth the potentially dilutive securities that were not included in the calculation of diluted earnings per share of common stock for three and six months ended June 30, 2026 and 2025:

**11.**Fair value of financial instruments

Fair value is a market-based measurement, not an entity specific measurement and is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three-level hierarchy:

Level 3: Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.

The following table sets forth our financial assets and liabilities, subject to fair value measurements on a recurring basis, by level within the fair value hierarchy(in thousands):