Quarterly Report for Quarter Ending September 30, 2026 (Form 10-Q)

MetaVia Inc.

Form 10-Q

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DA-1726

We initiated a Phase 1 clinical trial in 2024 with the goal of establishing the safety and tolerability of DA-1726 while exploring the mechanism of action and efficacy of DA-1726 in the treatment of obesity. This is the first-in-human clinical trial for DA-1726. We started Part 3a and Part 3b of the Phase 1 clinical trial in April 2026. Part 3a will be a one-step titration with 16 mg for four weeks and 48 mg for 12 weeks. Part 3b will be a two-step titration with 16 mg for four weeks, 32 mg for four weeks and 64 mg for eight weeks. These titration studies are to see if the graduated increase in dose can remove any moderate adverse effects from the 48 mg dose level and to seek DA-1726 at a higher dose level of 64 mg. We expect dose-dependent exploratory weight loss and other early signals in the exploratory endpoints with potential for best-in-class safety and tolerability. We expect to report full data from Part 3a and Part 3b in the first quarter of 2027.

For additional information on DA-1726, see "Part I, Item 1. Business, Our Pipeline, DA-1726 Treatment of Obesity" in our 2025 Form 10-K and our Current Reports on Form 8-K dated January 5, 2026, March 18, 2026, April 10, 2026, May 11, 2026, May 18, 2026, May 27, 2026, June 8, 2026, July 9, 2026, September 9, 2026, October 28, 2026, November 5, 2026 and November 12, 2026.

Recent developments

Key operating information

Our key operating information is described in "Key operating information" within "Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" in our 2025 Form 10-K. There have been no material changes to our key operating information.

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Results of operations

Three months ended September 30, 2026 compared to three months ended September 30, 2025

The following table summarizes our results of operations (in thousands, except share and per share amounts):

Total operating expenses and loss from operations

Our total operating expenses and loss from operations for the three months ended September 30, 2026 were $4.7 million, an increase of $1.2 million, or 35.1%, compared to the corresponding period in 2025. This increase was mainly attributable to higher R&D expenses and G&A expenses for the three months ended September 30, 2026. Our R&D expenses were $2.6 million for the three months ended September 30, 2026, an increase of $0.7 million, or 35.3%, compared to the corresponding period in 2025. Our G&A expenses were $2.1 million for the three months ended September 30, 2026, an increase of $0.5 million, or 34.8%, compared to the corresponding period in 2025.

The following table summarizes our R&D expenses for the three months ended September 30, 2026 and 2025 (in thousands):

The $0.7 million increase in R&D expenses reflects increased R&D activities related to the Phase 1 clinical trial for DA-1726 during the three months ended September 30, 2026 as compared to the corresponding period in 2025. Specifically, the increase in R&D expenses was primarily attributable to higher direct R&D expenses related to DA-1726 product development, partially offset by $0.2 million in lower indirect consulting expenses. Included in direct R&D costs were expenses totaling $0.3 million and $0.2 million for the three months ended September 30, 2026 and 2025, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party).

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The $0.5 million increase in G&A expenses was primarily attributable to (i) $0.2 million in higher legal and professional fees, (ii) $0.2 million in higher consulting expenditures and (iii) $0.1 million in higher employee compensation and benefits.

Total other income

Our total other income for the three months ended September 30, 2026 was $0.1 million, a decrease of less than $0.1 million, or 28.6%, compared to the corresponding period in 2025. This decrease was attributable to lower interest income, net, due primarily to lower balances of cash and cash equivalents, partially offset by a lower loss from the change in fair value of warrant liabilities.

Provision for income taxes

Our provision for income taxes and effective tax rate for the three months ended September 30, 2026 and 2025 were zero as we have recorded a full valuation allowance for the income tax benefits attributable to our pre-tax losses.

Net loss

For the three months ended September 30, 2026, we had a net loss of $4.6 million, or $0.69 per share of basic and diluted common stock, compared to a net loss of $3.4 million, or $1.52 per share of basic and diluted common stock for the corresponding period in 2025. The increase in net loss was primarily due to the factors described above.

Nine months ended September 30, 2026 compared to nine months ended September 30, 2025

The following table summarizes our results of operations (in thousands, except share and per share amounts):

Total operating expenses and loss from operations

Our total operating expenses and loss from operations for the nine months ended September 30, 2026 were $14.1 million, an increase of $2.4 million, or 20.9%, compared to the corresponding period in 2025. This increase was attributable to higher R&D and G&A expenses for the nine months ended September 30, 2026. Our R&D expenses were $8.2 million for the nine months ended September 30, 2026, an increase of $1.6 million, or 24.5%, compared to the corresponding period in 2025. Our G&A expenses were $5.9 million for the nine months ended September 30, 2026, an increase of approximately $0.8 million, or 16.3%, compared to the corresponding period in 2025.

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The following table summarizes our R&D expenses for the nine months ended September 30, 2026 and 2025 (in thousands):

The $1.6 million increase in R&D expenses reflects increased R&D activities related to the Phase 1 clinical trial for DA-1726 during the nine months ended September 30, 2026 as compared to the corresponding period in 2025. Specifically, the increase in R&D expenses was primarily attributable to $2.0 million in higher direct R&D expenses related to DA-1726 product development, partially offset by (i) $0.2 million in lower indirect consulting expenditures and (ii) $0.2 million in lower direct R&D expenses related to vanoglipel product development. Included in direct R&D costs were expenses totaling $1.2 million and $2.6 million for the nine months ended September 30, 2026 and 2025, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party).

The $0.8 million increase in G&A expenses was primarily attributable to (i) approximately $0.3 million in higher consulting expenditures, (ii) $0.2 million in higher legal and professional fees, (iii) $0.1 million higher employee compensation and benefits costs and (iv) $0.2 million in higher other G&A expenses, which was primarily related to higher franchise tax expenses.

Total other income

Our total other income for the nine months ended September 30, 2026 was $0.3 million, a decrease of approximately $0.3 million, or 44.9%, compared to the corresponding period in 2025. This decrease was attributable to (i) $0.1 million in lower gain from change in fair value of warrant liabilities and (ii) $0.2 million in lower interest income, net, due to lower balances of cash and cash equivalents and lower interest rates.

Provision for income taxes

Our provision for income taxes and effective tax rate for the nine months ended September 30, 2026 and 2025 were zero as we have recorded a full valuation allowance for the income tax benefits attributable to our pre-tax losses.

Net loss

For the nine months ended September 30, 2026, we had a net loss of $13.8 million, or $2.36 per share of basic and diluted common stock, compared to a net loss of $11.0 million, or $6.93 per share of basic and diluted common stock for the corresponding period in 2025. The increase in net loss was primarily due to the factors described above.

Going concern

As reflected in the unaudited condensed consolidated financial statements, we had $8.8 million in cash and cash equivalents as of September 30, 2026. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $162.6 million as of September 30, 2026. We have incurred a net loss of $13.8 million and net cash used in operating activities of $11.7 million for the nine months ended September 30, 2026. Due in large part to the 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 unaudited condensed consolidated financial statements.

We plan to continue to fund our operations from equity offerings, debt financing, exercise of existing warrants, or other sources,

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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 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 unaudited 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.

Liquidity and capital resources

Our primary use of cash is to fund our R&D activities. We have funded our operations primarily through public offerings of our common stock and private placements of equity and convertible securities. As of September 30, 2026, we had cash and cash equivalents totaling $8.8 million. We maintain cash and cash equivalents at a financial institution that at times may exceed the Federal Deposit Insurance Corporation insured limits of $0.25 million per bank. To date, we have not experienced any losses related to these funds. Our cash equivalents consist principally of money market funds and these securities are carried at cost, which approximates market fair value.

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 purchase 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 purchase price of $3.099 per Class B Unit.

Each pre-funded warrant had an exercise price of $0.001 per share, and was immediately exercisable and would 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 Common Warrants and Series D Common Warrants are fixed priced and do not contain any variable pricing features or alternative exercise provisions.

The following table provides information on the warrants exercised during the nine months ended September 30, 2026:

MetaVia Inc.

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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"). The offer and sale of the shares of common stock pursuant to the ATM Program 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 and July 2, 2026 pursuant to Rule 424(b) under the Securities Act.

From November 2025 to June 2026, we sold 529,707 shares of common stock for an aggregate sale price of $2.1 million under the ATM Program and received net proceeds of $1.6 million, net of sales agent commission and related offering expenses. The remaining $0.2 million amount under the ATM Program for the offer and sale of shares of our common stock was increased to $4.0 million on July 2, 2026. During the three months ended September 30, 2026, we sold 114,059 shares of common stock for an aggregate sale price of $0.2 million under the ATM Program and received net proceeds of $5 thousand, net of sales agent commission and related offering expenses. As of September 30, 2026, we had $3.8 million remaining under the ATM Program in which we may offer and sell shares of our common stock. For the nine months ended September 30, 2026, we sold 536,978 shares of common stock for an aggregate sale price of $1.1 million under the ATM Program and received net proceeds of $0.7 million, net of sales agent commission and related offering expenses.

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.

Cash flows

The principal use of cash in operating activities is to fund our current expenditures in support of our R&D activities. Financing activities currently represent the principal source of our cash flow. The following table reflects the major categories of cash flows (in thousands).

Net cash used in operating activities for the nine months ended September 30, 2026 was approximately $11.7 million and primarily attributable to net loss of $13.8 million, partially offset by changes in operating assets and liabilities of approximately $1.5 million and non-cash charges totaling approximately $0.5 million, which was primarily related to stock-based compensation, non-cash professional services expenses and change in fair value of warrant liabilities. Net cash used in operating activities for the nine months ended September 30, 2025 was $10.8 million and primarily consisted of net loss of $11.0 million, partially offset by non-cash charges totaling $0.2 million, which was primarily related to stock-based compensation and non-cash professional services expenses, net of gain from change in fair value of warrant liabilities.

Net cash flows used in investing activities for the nine months ended September 30, 2026 and 2025 were minimal and related to the purchase of property and equipment.

Net cash provided by financing activities for the nine months ended September 30, 2026 was $10.3 million and primarily attributable to gross proceeds of (i) $9.3 million from an underwritten public offering in January 2026, (ii) $1.1 million from

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the sale of common stock under the ATM Sales Agreement and (iii) $2.4 million from exercise of warrants. Partially offsetting these gross proceeds was an aggregate payment of approximately $2.6 million in issuance costs in connection with the sale of common stock and warrants under an underwritten public offering and under an at the ATM Program. Net cash provided by financing activities for the nine months ended September 30, 2025 was $9.1 million and primarily consisted of gross proceeds of $10.0 million from the May 2025 private placement offering, partially offset by the payment of $0.9 million of issuance costs in connection with the May 2025 private placement offering.

For additional details, see the unaudited condensed consolidated statements of cash flows in the unaudited condensed consolidated financial statements included elsewhere in this Report.

Critical accounting estimates

Our unaudited condensed consolidated financial statements included in this Report have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP").

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 unaudited condensed consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in our unaudited condensed consolidated financial statements relate to accrued expenses 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.

There have been no material changes to our critical accounting estimates and judgments since December 31, 2025. Refer to our 2025 Form 10-K for a complete discussion of our critical accounting estimates and judgments.

Recent accounting pronouncements

Information regarding (i) adoption of new accounting standards and (ii) accounting standards issued but not yet adopted is included in "Note 1. Business, basis of presentation, new accounting standards and summary of significant accounting policies" to the unaudited condensed consolidated financial statements included in this Report.

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