MetaVia Inc.

Previous wording

We are a clinical-stage biotechnology company focused primarily on developing novel pharmaceuticals to treat cardiometabolic diseases. MetaVia has two programs focused primarily on the treatment ofmetabolic dysfunction-associated steatohepatitis (“MASH”) and obesity.

Current wording

We are a clinical-stage biotechnology company focused primarily on developing novel pharmaceuticals to treat cardiometabolic diseases. MetaVia has two ongoing programs focused primarily on the treatment ofmetabolic dysfunction-associated steatohepatitis (“MASH”) and obesity.

Previous wording

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.

Current wording

While we primarily focus our financial resources and management’s attention on the development of Vanoglipel (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.

Previous wording

In December 2024, we announced positive top-line 16-week results from the two-part Phase 2a clinical trial in patients with presumed MASH. Part 1 of this Phase 2a trial is exploring DA-1241, a novel GPR119 agonist compared to placebo, while Part 2 is investigating the efficacy of DA-1241 in combination with sitagliptin, a DPP-4 inhibitor.

Current wording

In December 2024, we announced positive top-line 16-week results from the two-part Phase 2a clinical trial in patients with presumed MASH. Part 1 of this Phase 2a trial is exploring Vanoglipel (DA-1241), a novel GPR119 agonist compared to placebo, while Part 2 is investigating the efficacy of Vanoglipel (DA-1241) in combination with sitagliptin, a DPP-4 inhibitor.

Previous wording

We are currently working to schedule an end-of-Phase 2 meeting with the FDA. For additional information on DA-1241, 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, DA-1241 Treatment of MASH” in our 2024 Form 10-K.

Current wording

We are currently working to schedule an end-of-Phase 2 meeting with the Food and Drug Administration (“FDA”). For additional information on Vanoglipel (DA-1241), 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 2024 Form 10-K.

Previous wording

In September 2024, we announced positive top-line data from the single ascending dose Part 1 of our Phase 1 trial evaluating DA-1726. In April 2025, we announced positive top-line data from the multiple ascending dose (“MAD”) Part 2 study of our Phase 1 trial. In late June 2025, we began enrollment for a higher-dose cohort to assess the maximum tolerated dose and fully realize DA-1726's potential, as higher doses may also show a similar profile, while potentially demonstrating increased weight reduction. In July 2025, we dosed the first patient in the 48 mg, MAD cohort of our Phase 1 clinical trial of DA-1726. In August 2025, we administered the fifth dose for the first patient in the MAD cohort of our Phase 1 clinical trial of DA-1726. Top-line data of the 48 mg MAD cohort is expected in the fourth quarter of 2025.

Current wording

In June 2025, we began enrollment for a higher-dose MAD cohort to assess the maximum tolerated dose and fully realize DA-1726's potential, as higher doses may also show a similar profile, while potentially demonstrating increased weight reduction. We dosed the first patient in the 48 mg, MAD cohort of our Phase 1 clinical trial of DA-1726 in July 2025 and we extended the clinical trial for this 48 mg, MAD cohort to 8 weeks from 4 weeks to further explore the non-titrated maximum tolerated dose, explore safety and other primary, secondary and exploratory endpoints over a longer treatment duration, and evaluate longer-term early efficacy. Also, in August 2025, we administered the fifth dose for the first patient in the 48 mg, MAD cohort of our Phase 1 clinical trial of DA-1726. Top-line data of the 48 mg, MAD cohort is expected in the fourth quarter of 2025.

Previous wording

The successful development and commercialization of our product candidates are highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates. Additionally, because of the risks inherent in novel treatment discovery

Current wording

The successful development and commercialization of our product candidates are highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates. Additionally, because of the risks inherent in novel treatment discovery and development, we cannot reasonably estimate or know:

Previous wording

Our total operating expenses and loss from operations for the three months ended June 30, 2025 were $4.3 million, a decrease of $5.8 million, or 57.3%, compared to the three months ended June 30, 2024. This decrease was mainly attributable to lower R&D for the three months ended June 30, 2025. Our R&D expenses were $2.3 million for the three months ended June 30, 2025, a decrease of $5.8 million, or 71.3%, compared to the three months ended June 30, 2024. Ourgeneral and administrative expenses were $2.0 million for the three months ended June 30, 2025 and 2024.

Current wording

Our total operating expenses and loss from operations for the three months ended September 30, 2025 were $3.5 million, a decrease of $2.8 million, or 44.5%, compared to the three months ended September 30, 2024. This decrease was mainly attributable to lower R&D for the three months ended September 30, 2025. Our R&D expenses were $1.9 million for the three months ended September 30, 2025, a decrease of $2.6 million, or 57.6%, compared to the three months ended September 30, 2024. Ourgeneral and administrative expenses were $1.6 million for the three months ended September 30, 2025, a decrease of $0.2 million, or 10.4%, compared to the three months ended September 30, 2024.

Previous wording

The $5.8 million decrease in R&D expenses reflects decreased R&D activities related to the Phase 2a clinical trial for DA-1241 and decreased activities related to the Phase 1 trial for DA-1726 as compared to the three months ended June 30, 2024. Specifically, the decrease in R&D expenses was primarily attributable to (i) $2.4 million in lower direct R&D expenses related to DA-1241 product development, (ii) $3.4 million in lower direct R&D expenses related to DA-1726 product development, and (iii) $0.1 million in lower direct other R&D costs. These decreases were partially offset by an aggregate $0.1 million increase in indirect R&D expenses related to employee compensation and benefits, and consulting. Included in direct R&D costs were expenses totaling $1.3 million and $3.4 million for the three months ended June 30, 2025 and 2024, 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 $2.6 million decrease in R&D expenses reflects decreased R&D activities related to the Phase 2a clinical trial for Vanoglipel (DA-1241) and decreased activities related to the Phase 1 trial for DA-1726 as compared to the three months ended September 30, 2024. Specifically, the decrease in R&D expenses was primarily attributable to (i) $2.4 million in lower direct R&D expenses related to Vanoglipel (DA-1241) product development and (ii) $0.4 million in lower direct R&D expenses related to DA-1726 product development. These decreases were partially offset by (i) $0.1 million in higher direct other R&D costs and (ii) $0.1 million in higher indirect consulting expenses. Included in direct R&D costs (credits) were expenses totaling $0.2 million and $0.7 million for the three months ended September 30, 2025 and 2024, 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

Our total other income for thethree months ended June 30, 2025 were $0.3 million, an increase of $0.3 million, compared to the three months ended June 30, 2024. This was mainly attributable to the $0.3 million increase in the change in fair value of warrant liabilities. We recorded a gain of $0.2 million from the change in fair value of warrant liabilities during the three months ended June 30, 2025 compared to a loss of $0.1 million from the change in fair value of warrant liabilities during the three months ended June 30, 2024.

Current wording

Our total other income for thethree months ended September 30, 2025 was $0.1 million, a decrease of $0.5 million, compared to the three months ended September 30, 2024. This decrease was primarily attributable to (i) $0.2 million in lower interest income, net, due to lower cash balances and lower interest rates and (ii) approximately $0.4 million related to the change in fair value of warrant liabilities. We recorded a loss of $0.1 million from the change in fair value of warrant liabilities during the three months ended September 30, 2025 compared to a gain of $0.3 million from the change in fair value of warrant liabilities during the three months ended September 30, 2024.

Previous wording

For the three months ended June 30, 2025, we had a net loss of $4.0 million, or $0.26 per share of basic and diluted common stock, compared to a net loss of $10.0 million, or $1.85 per share of basic and diluted common stock for the three months ended June 30, 2024, primarily due to the factors described above.

Current wording

For the three months ended September 30, 2025, we had a net loss of $3.4 million, or $0.14 per share of basic and diluted common stock, compared to a net loss of $5.7 million, or $0.55 per share of basic and diluted common stock for the three months ended September 30, 2024, primarily due to the factors described above.

Previous wording

Our total operating expenses and loss from operations for the six months ended June 30, 2025 were $8.2 million, a decrease of $8.8 million, or 51.7%, compared to the six months ended June 30, 2024. This decrease was attributable to lower R&D and general and administrative expenses for the six months ended June 30, 2025. Our R&D expenses were $4.6 million for the six months ended June 30, 2025, a decrease of $8.3 million, or 64.2%, compared to the six months ended June 30, 2024. Ourgeneral and administrative expenses were $3.5 million for the six months ended June 30, 2025, a decrease of $0.4 million, or 11.2%, compared to the six months ended June 30, 2024.

Current wording

Our total operating expenses and loss from operations for the nine months ended September 30, 2025 were $11.7 million, a decrease of $11.6 million, or 49.8%, compared to the nine months ended September 30, 2024. This decrease was attributable to lower R&D and general and administrative expenses for the nine months ended September 30, 2025. Our R&D expenses were $6.6 million for the nine months ended September 30, 2025, a decrease of $10.9 million, or 62.5%, compared to the nine months ended September 30, 2024. Ourgeneral and administrative expenses were $5.1 million for the nine months ended September 30, 2025, a decrease of $0.6 million, or 11.0%, compared to the nine months ended September 30, 2024.

Previous wording

The following table summarizes our R&D expenses for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our R&D expenses for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

The $8.3 million decrease in R&D expenses reflects decreased R&D activities related to the Phase 2a clinical trial for DA-1241 and decreased activities related to the Phase 1 trial for DA-1726 as compared to the six months ended June 30, 2024. Specifically, the decrease in R&D expenses was primarily attributable to (i) $5.3 million in lower direct R&D expenses related to DA-1241 product development, (ii) $2.9 million in lower direct R&D expenses related to DA-1726 product development, and (iii) $0.3 million in lower direct other R&D costs. These decreases were partially offset by $0.2 million in higher indirect R&D expenses related to employee compensation and benefits. Included in direct R&D costs were expenses totaling $2.4 million and $3.6 million for the six months ended June 30, 2025 and 2024, 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 $10.9 million decrease in R&D expenses reflects decreased R&D activities related to the Phase 2a clinical trial for Vanoglipel (DA-1241) and decreased activities related to the Phase 1 trial for DA-1726 as compared to the nine months ended September 30, 2024. Specifically, the decrease in R&D expenses was primarily attributable to (i) $7.6 million in lower direct R&D expenses related to Vanoglipel (DA-1241) product development, (ii) $3.3 million in lower direct R&D expenses related to DA-1726 product development, and (iii) $0.1 million in lower direct other R&D costs. These decreases were partially offset by $0.1 million in higher indirect employee compensation and benefits cost and $0.1 million in higher indirect consulting expenses. Included in direct R&D costs were expenses totaling $2.6 million and $4.3 million for the nine months ended September 30, 2025 and 2024, 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 $0.4 million decrease ingeneral and administrative expenses was primarily attributable to (i) $0.7 million in lower consulting expenditures and (ii) $0.2 million in lower other G&A expenses. These decreases were partially offset by (i) $0.3 million in higher legal and professional fees and (ii) $0.2 million in higher employee compensation and benefits.

Current wording

The $0.6 million decrease ingeneral and administrative expenses was primarily attributable to (i) $0.9 million in lower consulting expenditures and (ii) $0.2 million in lower other general and administrative expenses. These decreases were partially offset by (i) $0.4 million in higher legal and professional fees and (ii) $0.1 million in higher employee compensation and benefits.

Previous wording

Our total other income for thesix months ended June 30, 2025 were $0.5 million, an increase of $0.3 million, compared to the six months ended June 30, 2024. This was attributable to the $0.5 million increase in the change in fair value of warrant liabilities, partially offset by $0.1 million in lower interest income. We recorded a gain of $0.2 million from the change in fair value of warrant liabilities during the six months ended June 30, 2025 compared to a loss of $0.2 million from the change in fair value of warrant liabilities during the six months ended June 30, 2024. The decrease in interest was due to lower average invested amount during the six months ended June 30, 2025 and lower interest rates.

Current wording

Our total other income for thenine months ended September 30, 2025 was $0.6 million, a decrease of $0.2 million, compared to the nine months ended September 30, 2024. This was attributable to $0.3 million in lower interest income, net, due to lower cash balances and lower interest rates, partially offset by a $0.1 million increase in gain from change in fair value of warrant liabilities. We recorded a gain of $0.2 million and $0.1 million from the change in fair value of warrant liabilities during the nine months ended September 30, 2025 and 2024, respectively.

Previous wording

Our effective tax rate for thesix months ended June 30, 2025 and 2024 was zero percent as we have recorded a full valuation allowance for the income tax benefits attributable to our pre-tax losses.

Current wording

Our effective tax rate for thenine months ended September 30, 2025 and 2024 was zero percent as we have recorded a full valuation allowance for the income tax benefits attributable to our pre-tax losses.

Previous wording

For the six months ended June 30, 2025, we had a net loss of $7.7 million, or $0.60 per share of basic and diluted common stock, compared to a net loss of $16.8 million, or $3.19 per share of basic and diluted common stock for the six months ended June 30, 2024, primarily due to the factors described above.

Current wording

For the nine months ended September 30, 2025, we had a net loss of $11.0 million, or $0.63 per share of basic and diluted common stock, compared to a net loss of $22.4 million, or $3.24 per share of basic and diluted common stock for the nine months ended September 30, 2024, primarily due to the factors described above.

Previous wording

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.

Current wording

As reflected in the condensed consolidated financial statements, we had $14.3 million in cash as of September 30, 2025. We believe that our existing cash will be sufficient to fund our operations into 2026. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $146.9 million as of September 30, 2025. We have incurred a net loss of $11.0 million and net cash used in operating activities of $10.8 million for the nine months ended September 30, 2025. 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 condensed consolidated financial statements.

Previous wording

We believe that our existing cash will be sufficient to fund our operations into 2026. 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.

Current 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 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.

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 June 30, 2025, we had cash totaling $17.6 million. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $250 thousand per bank. Our cash balance includes liquid insured deposits, which are obligations

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 September 30, 2025, we had cash totaling $14.3 million. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $250 thousand per bank. Our cash balance includes liquid insured deposits, which are obligations

Previous wording

of the program banks in which the deposits are held and qualify for FDIC insurance protection per depositor in each recognized legal category of account ownership in accordance with the rules of the FDIC. To date, we have not experienced any losses related to these funds.

Current wording

of the banks in which the deposits are held and which qualify for FDIC insurance protection in accordance with the rules of the FDIC. To date, we have not experienced any losses related to these funds.

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 was $7.9 million for the six months ended June 30, 2025 and consisted of net loss of $7.7 million and net cash used in change in operating assets and liabilities of $0.2 million. Net cash used in operating activities was $13.7 million for the six months ended June 30, 2024 and consisted of net loss of $16.8 million, partially offset by net cash provided by changes in operating assets and liabilities of $2.6 million and non-cash charges totaling $0.5 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 was $10.8 million for the nine months ended September 30, 2025 and 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 change in fair value of warrant liabilities. Net cash used in operating activities was $19.2 million for the nine months ended September 30, 2024 and consisted of net loss of $22.4 million, partially offset by net cash provided by changes in operating assets and liabilities of $2.9 million and non-cash charges totaling $0.3 million, which was primarily related to stock-based compensation and change in fair value of warrant liabilities.

Previous wording

Net cash used in investing activities, related to the purchase of property and equipment, was less than $0.1 million for the six months ended June 30, 2025 and 2024.

Current wording

Net cash used in investing activities, related to the purchase of property and equipment, was less than $0.1 million for the nine months ended September 30, 2025 and 2024.

Previous wording

Net cash provided by financing activities was $9.5 million for the six months ended June 30, 2025, which primarily consisted of gross proceeds of $10.0 million from an equity offering in May 2025, net of payment of issuance cost of $0.5 million. Net cash provided by financing activities of $19.2 million for the six months ended June 30, 2024, which primarily consisted of gross proceeds of $20.0 million from an equity offering in June 2024, net of payment of issuance cost of $0.8 million.

Current wording

Net cash provided by financing activities was $9.1 million for the nine months ended September 30, 2025, which primarily consisted of gross proceeds of $10.0 million from an equity offering in May 2025, net of payment of issuance cost of $0.9 million. Net cash provided by financing activities of $18.5 million for the nine months ended September 30, 2024, which primarily consisted of gross proceeds of $20.0 million from an equity offering in June 2024, net of payment of issuance cost of $1.5 million.

Previous wording

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 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

Current wording

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 accrued expenses and the fair value of