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 condensed consolidated financial statements of the Company as “MetaVia,” “we,” “our” and “us.”We are a clinical-stage biotechnology company focused primarily ondeveloping novel pharmaceuticals to treat cardiometabolic diseases. MetaVia has two programs focused primarily on the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and obesity, DA-1241 and DA-1726.

While we primarily focus our financial resources and management’s attention on the development of DA-1241 and DA-1726, we also have four legacy therapeutic programs designed to impact a range of indications in viral, neurodegenerative and cardiometabolic diseases on which we are not planning to advance development and have, or continue to consider for, out-licensing and divestiture opportunities.

Our operations have consisted principally of performing research and development (“R&D”) activities, which include preclinical developments 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$17.6 million in cash as of June 30, 2025. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $143.5 million as of June 30, 2025. We have incurred a net loss of$7.7 million and net cash used in operating activities of$7.9 million for the six months ended June 30, 2025. Due in large part to the ongoing Phase 2a clinical trial for DA-1241 and Phase 1 clinical trial for DA-1726, 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 from equity offerings, debt financing, 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 Series B warrants issued in June 2024 will be exercised. To the extent that we can raise additional funds by issuing equity securities or in the event our existing 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 us.

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, 2024 (“2024 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 2024 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

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures to improve the transparency of income tax disclosures by amending the required rate reconciliation disclosures as well as requiring disclosure of income taxes paid disaggregated by jurisdiction. As amended, the rate reconciliation disclosure will be required to be presented in both percentages and reporting currency amounts, with consistent categories and greater disaggregation of information. This ASU also includes amendments intended to improve the effectiveness of income tax disclosures and eliminate certain existing disclosure requirements related to uncertain tax positions and unrecognized deferred tax liabilities. This ASU iseffective for annual periods beginning after December 15, 2024. We do not expect the adoption of ASU 2023-09 to have a significant impact on our consolidated financial statements and accompanying notes for the year ended December 31, 2025.

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 225-01, 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 are currently evaluating 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 condensed 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, 2024, which is included in our 2024 Form 10-K. Except as disclosed below, there have been no material changes to the Company’s significant accounting policies.

Segment reporting

We manage and operate asone reportable segment, which is principally the business of development of pharmaceutical products, withone geographic location in the United States. We do not operate separate lines of business with respect to each pharmaceutical product being studied in a clinical environment. 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.

**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 of $5 thousand and $9 thousand for the three and six months ended June 30, 2025 and $6 thousand and $10 thousand for the three and six months ended June 30, 2024, which was included in general and administrative operating expenses in the accompanying condensed consolidated statements of operations.

**4.**Current liabilities

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 DA-1241 for treatment of MASH and DA-1726 for treatment of obesity and MASH. The 2022 License Agreement also provides that we may develop DA-1241 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 DA-1241 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 DA-1241 and DA-1726 under the terms provided in the Shared Services Agreement.

We incurred R&D expenses of$1.3 million and$2.4 million for the three and six months ended June 30, 2025, respectively,$3.4 million and$3.6 million for the three and six months ended June 30, 2024, respectively, under the Shared Services Agreement, which are included in operating expenses: research and development in the accompanying condensed consolidated statements of operations. Theaggregate amount payable to Dong-A ST is$3.7 million and$1.5 million as of June 30, 2025 and December 31, 2024, respectively, under the Shared Services Agreement, which are included in related party payable in the accompanying condensed consolidated balance sheets.

For additional information on the 2022 License Agreement, the Shared Service 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, 2024, which is included in our 2024 Form 10-K.

**6.**Stockholders’ equity

Private Placement

In May 2025, we closed on a private placement offering with Dong-A ST, a related party, 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)9,479,345 shares of

our common stock for a purchase price of $0.71 per share, and (ii)4,605,162 pre-funded warrants to purchase up to an equivalent number of shares of our common stock for a purchase price of $0.709 per pre-funded warrant.

Each pre-funded warrant had an exercise price of $0.001 per share, and was exercisable beginning on the effective date of receiving stockholder approval for the issuance of the shares of common stock underlying the pre-funded warrants, which was received on June 30, 2025. All pre-funded warrants issued in May 2025 were exercised on June 30, 2025 for an equivalent number of shares of our common stock.

Warrants

The following tables summarize our outstanding warrants:

(1)The number of outstanding and exercisable warrants is equal to the number of shares of common stock issuable for outstanding warrants. Additionally, the 159 warrants issued in April 2020 and the 15,390 warrants issued in October 2021 expired unexercised in April 2025.

(3)These warrants are exercisable at any time from September 18, 2024 (“Stockholder Approval Date”) and expire in July 2026.

(4)These warrants are exercisable immediately upon their issuance in June 2024 and are considered to be perpetual warrants without any expiration date. Additionally, in the second quarter of 2025,1,430,000 pre-funded warrants were exercised for an equivalent number of shares of our common stock.

(5)These warrants were exercisable at any time from the Stockholder Approval Date and expire in June 2025. Additionally, the 5,089,660 Series A warrants issued in June 2024 expired unexercised in June 2025.

(6)These warrants were exercisable at any time from the Stockholder Approval Date and expired on the earlier of (i) thefive-year anniversary of the Stockholder Approval Date and (ii) thesix months anniversary following the date on which the Company publicly announce the receiving of positive Phase 1, Part 3 data readout for DA-1726.

Stock-based compensation

Stock-based compensation expense was included in general and administrative operating expense and research and development operating expense as follows(in thousands):

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 2025, the 2022 Plan automatically increased the aggregate number of shares of common stock that may be issued pursuant to Awards by 1,694,929 shares. The following table summarizes the outstanding awards issued pursuant to our stock-based award plans and inducement plan as of June 30, 2025 and the remaining shares of common stock available for future issuance:

For stock-based awards granted under our stock-based award plans as of June 30, 2025, unrecognized stock-based compensation costs totaled $0.4 million. The unrecognized stock-based costs are expected to be recognized as an expense over a weighted average period of 1.3 years.

Restricted Stock Units

The following table summarizes the status of our restricted stock units (“ RSUs”) and related transactions for the period presented (in thousands, except share and per share amounts):

Stock options

The following table summarizes the status of our outstanding and exercisable options and related transactions for the period presented (in thousands, except share and per share amounts):

**7.**Significant segment expenses

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

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

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

8**.**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 six months ended June 30, 2025, (ii) additional losses expected for the remainder of 2025, 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, 2025 and 2024. Accordingly, there wereno benefits for income taxes recorded for the three and six months ended June 30, 2025 and

2024. Additionally, as of June 30, 2025 and December 31, 2024, we maintain a full valuation allowance for all deferred tax assets.

**9.**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 in June 2024 and May 2025 and (iii) vested RSUs in which their release was deferred.

Since we reported a net loss for the three and six months ended June 30, 2025 and 2024, 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 three and six months ended June 30, 2025 and 2024.

The following table sets forth the potentially dilutive securities that were not included in the calculation of diluted earnings per share of common stock as of and for the six months ended June 30, 2025 and 2024:

**10.**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):