MetaVia Inc.

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and related notes included elsewhere in this Report and the audited financial statements and related notes included in our 2025 Form 10-K. This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. See “Special Note Regarding Forward-Looking Statements.” Our actual results may differ materially from those contained in or implied by any forward-looking statements as a result of various factors, including, but not limited to, the risks and uncertainties described under Part II, Item 1A. Risk Factors, elsewhere in this Report.

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and related notes included elsewhere in this Report and the audited financial statements and related notes included in our 2025 Form 10-K. This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. See “Special Note Regarding Forward-Looking Statements.” Our actual results may differ materially from those contained in or implied by any forward-looking statements as a result of various factors, including, but not limited to, the risks and uncertainties described under Part II, Item 1A. Risk Factors, elsewhere in this Report. Certain amounts in the following discussion and analysis may not add up due to rounding, and all percentages have been calculated using unrounded amounts.

Previous wording

We initiated a Phase 2a clinical trial in 2023 with the goal of establishing the mechanism of action and efficacy of vanoglipel in the treatment of MASH and to evaluate trends for T2DM. This is the first-in-human MASH clinical trial for vanoglipel. We are expecting to finalize the Clinical Study Report of the Phase 2a clinical trial in the first half of 2026. We are also currently working to schedule an end-of-Phase 2a meeting with the Food and Drug Administration.

Current wording

We initiated a Phase 2a clinical trial in 2023 with the goal of establishing the mechanism of action and efficacy of vanoglipel in the treatment of MASH and to evaluate trends for T2DM. This is the first-in-human MASH clinical trial for vanoglipel. We are expecting to finalize the Clinical Study Report of the Phase 2a clinical trial in the fourth quarter of 2026. We are also currently working to schedule an end-of-Phase 2 meeting with the Food and Drug Administration to discuss the clinical development pathway for the vanoglipel combination therapy.

Previous wording

For additional information on vanoglipel, including an overview of the top-line 16-week results from the two-part Phase 2a clinical trial, see “Part I, Item 1. Business, Our Pipeline, vanoglipel (DA-1241) Treatment of MASH” in our 2025 Form 10-K.

Current wording

For additional information on vanoglipel, including an overview of the top-line 16-week results from the two-part Phase 2a clinical trial, see “Part I, Item 1. Business, Our Pipeline, vanoglipel (DA-1241) Treatment of MASH” in our 2025 Form 10-K and our Current Reports on Form 8-Ks dated May 18, 2026 and June 8, 2026.

Previous wording

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 it 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. The data readout for both Part 3a and Part 3b is planned for the fourth quarter of 2026.

Current wording

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. The data readout for both Part 3a and Part 3b is planned for the fourth quarter of 2026.

Previous wording

Our total operating expenses and loss from operations for the three months ended March 31, 2026 were $4.0 million, an increase of approximately $0.1 million, or 3.6%, compared to the corresponding period in 2025. This increase was mainly attributable to higher general and administrative (“G&A”) expensesfor the three months ended March 31, 2026, partially offset by lower R&D expenses. Our R&D expenses were $2.1 million for the three months ended March 31, 2026, a decrease of $0.2 million, or 9.7%, compared to the corresponding period in 2025. Our G&A expenses were $1.9 million for the three months ended March 31, 2026, an increase of approximately $0.4 million, or 23.4%, compared to the corresponding period in 2025.

Current wording

Our total operating expenses and loss from operations for the three months ended June 30, 2026 were $5.4 million, an increase of approximately $1.1 million, or 25.2%, compared to the corresponding period in 2025. This increase was mainly attributable to higher R&Dexpensesfor the three months ended June 30, 2026, partially offset by lower general and administrative (“G&A”) expenses. Our R&D expenses were $3.5 million for the three months ended June 30, 2026, an increase of $1.2 million, or 49.9%, compared to the corresponding period in 2025. Our G&A expenses were $1.9 million for the three months ended June 30, 2026, a decrease of approximately $0.1 million, or 3.7%, compared to the corresponding period in 2025.

Previous wording

Our total other income for thethree months ended March 31, 2026 was $0.2 million, consistent with the corresponding period in 2025.

Current wording

Our total other income for thethree months ended June 30, 2026 was $0.1 million, a decrease of $0.2 million, or 77.5%, compared to the corresponding period in 2025. This decrease was attributable to an approximately $0.2 million negative impact from the change in fair value of warrant liabilities due to the impact of our common stock’s decline in stock price and approximately $0.1 million in lower interest income, net, due to lower balances of cash and cash equivalents and lower interest rates.

Previous wording

For the three months ended March 31, 2026, we had a net loss of $3.8 million, or $0.79 per share of basic and diluted common stock, compared to a net loss of $3.7 million, or $3.93 per share of basic and diluted common stock forthe corresponding period in 2025, primarily due to the factors described above.

Current wording

For the three months ended June 30, 2026, we had a net loss of $5.3 million, or $0.90 per share of basic and diluted common stock, compared to a net loss of $4.0 million, or $2.87 per share of basic and diluted common stock forthe corresponding period in 2025, primarily due to the factors described above.

Previous wording

The $0.2 million decrease in R&D expenses reflects decreased R&D activities related to the Phase 2a clinical trial for vanoglipel during the three months ended March 31, 2026 as compared to the corresponding period in 2025. Specifically, the decrease in R&D expenses was primarily attributable to (i) $0.1 million in lower direct R&D expenses related to vanoglipel product development and (ii) $0.1 million in lower indirect employee compensation and benefits costs. Included in direct R&D costs were expenses totaling $0.7 million and $1.1 million for the three months ended March 31, 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).

Current wording

The $0.9 million increase in R&D expenses reflects increased R&D activities related to the Phase 1 clinical trial for DA-1726 during the six months ended June 30, 2026 as compared to the corresponding period in 2025. Specifically, the increase in R&D expenses was primarily attributable to $1.2 million in higher direct R&D expenses related to DA-1726 product development, partially offset by (i) $0.2 million in lower direct R&D expenses related to vanoglipel product development and (ii) $0.1 million in lower indirect employee compensation and benefits costs. Included in direct R&D costs were expenses totaling $0.9 million and $2.4 million for the six months ended June 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).

Previous wording

The approximately $0.4 million increase in G&A expenses was primarily attributable to (i) approximately $0.1 million in higher consulting expenditures, (ii) approximately $0.1 million in higher franchise tax expenses, and (iii) $0.1 million in higher legal and professional fees.

Current wording

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

Previous wording

cash used in operating activities of $4.3 million for the three months ended March 31, 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.

Current wording

As reflected in the unaudited 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 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.

Previous wording

We plan to continue to fund our operations from equity offerings, debt financing, 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 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.

Current wording

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.

Previous wording

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 March 31, 2026, we had cash and cash equivalents totaling $13.7 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 bank money market accounts and these securities are carried at cost, which approximates market value.

Current wording

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 June 30, 2026, we had cash and cash equivalents totaling $12.6 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 bank money market accounts and these securities are carried at cost, which approximates market value.

Previous wording

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 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.

Current wording

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.

Previous wording

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 may 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 is 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 to be filed with the SEC on November 6, 2025 pursuant to Rule 424(b) under the Securities Act.

Current wording

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.

Previous wording

In March 2026, we sold 216,625 shares of common stock under the ATM Program and received net proceeds of $0.3 million, net of sales agent commission and related offering expenses. As of March 31, 2026, we have $0.8 million remaining under the ATM Program in which we may offer and sell shares of our common stock.

Current wording

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.

Previous wording

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).

Current wording

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.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2026 was approximately $4.3 million and primarily attributable to net loss of $3.8 million and net cash used in changes in operating assets and liabilities of $0.4 million. Net cash used in operating activities for the three months ended March 31, 2025 was $4.8 million and primarily attributable to net loss of $3.7 million and net cash used in changes in operating assets and liabilities of $1.2 million, partially offset by non-cash charges totaling $0.1 million, which was primarily related to stock-based compensation and change in fair value of warrant liabilities.

Current wording

Net cash used in operating activities for the six months ended June 30, 2026 was approximately $8.0 million and primarily attributable to net loss of $9.1 million, partially offset by changes in operating assets and liabilities of $0.8 million and non-cash charges totaling $0.3 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 six months ended June 30, 2025 was $7.9 million and primarily attributable to net loss of $7.7 million and net cash used in changes in operating assets and liabilities of $0.2 million.

Previous wording

There were no cash flows used in or provided by investing activities for three months ended March 31, 2026 and 2025.

Current wording

There were no cash flows used in or provided by investing activities for the six months ended June 30, 2026 while cash used in investing activities for the six months ended June 30, 2025 was minimal and related to the purchase of property and equipment.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2026 was $7.7 million and primarily attributable to gross proceeds of (i) $9.3 million from an underwritten public offering in January 2026 and (ii) $0.3 million from the sale of common stock under the ATM Sales Agreement. Partially offsetting these gross proceeds was an aggregate payment of $1.9 million in issuance costs in connection with the sale of common stock and warrants under an underwritten public offering and under an at the market offering agreement. Net cash used in financing activities for the three months ended March 31, 2025 was less than $0.1 million, related to the payment of employee withholding taxes related to shares withheld from the issuance of vested restricted stock units.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $10.4 million and primarily attributable to gross proceeds of (i) $9.3 million from an underwritten public offering in January 2026, (ii) $0.9 million from 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 $2.3 million in issuance costs in connection with the sale of common stock and warrants under an underwritten public offering and under an at the market offering agreement. Net cash provided by financing activities for the six months ended June 30, 2025 was $9.5 million and primarily attributable to gross proceeds of $10.0 million from the