MetaVia Inc.

Previous wording

The Company expects to have an end-of-Phase 2 meeting with the FDA in the first half of 2025. 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 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.

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. Currently, we are planning to add higher-dose cohorts 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. The enrollment for the additional cohorts is expected to begin in the third quarter of 2025 with data expected in the fourth quarter of 2025.

Current 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.

Previous wording

For additional information on DA-1726, see “Part I, Item 1. Business, Our Pipeline, DA-1726 Treatment of Obesity” in our 2024 Form 10-K, our Current Report on Form 8-K (“Form 8-K) dated April 15, 2025, and our Form 8-K dated April 22, 2025.

Current wording

For additional information on DA-1726, see “Part I, Item 1. Business, Our Pipeline, DA-1726 Treatment of Obesity” in our 2024 Form 10-K, and our Current Reports on Form 8-K dated April 15, 2025, April 22, 2025, and July 9, 2025.

Previous wording

Our direct R&D expenses consist primarily of external costs, such as fees paid to CROs, CMOs, research laboratories and outside consultants in connection with our clinical development, quality assurance and quality control processes, manufacturing, and clinical development activities. Our direct research and development expenses also include fees incurred under third-party license agreements, including the Shared Services Agreement with Dong-A ST (related party). We utilize our employee and infrastructure resources across multiple research and development projects. We do not allocate employee costs and costs associated with our facilities, including depreciation or other indirect costs, to specific product candidates because these costs are deployed across multiple programs and, as such, are not separately classified. We utilize internal resources to manage CRO and CMO activities. These employees work across multiple programs. Our direct R&D expenses consist of (i) expenses attributable to our product candidates and (ii) certain other R&D expenses, including non-clinical and preclinical services or other R&D expenses that are not attributable to a single product candidate. Our indirect R&D expenses consist of (i) employment-related expenses for compensation and benefits, which are internal costs and (ii) consulting expenses.

Current wording

Our direct R&D expenses consist primarily of external costs, such as fees paid to CROs, CMOs, research laboratories and outside consultants in connection with our clinical development, quality assurance and quality control processes, manufacturing, and clinical development activities. Our direct research and development expenses also include fees incurred under third-party license agreements, including the Shared Services Agreement with Dong-A ST (related party). We utilize our employee and infrastructure resources across multiple research and development projects. We do not allocate employee costs and costs associated with our facilities, including depreciation or other indirect costs, to specific product candidates because these costs are deployed across multiple programs and, as such, are not separately classified. We utilize internal resources to manage CRO and CMO activities. These employees work across multiple programs. Our direct R&D expenses consist of (i) expenses attributable to our product candidates and (ii) certain other R&D expenses, including clinical, non-clinical and preclinical services or other R&D expenses that are not attributable to a single product candidate. Our indirect R&D expenses consist of (i) employment-related expenses for compensation and benefits, which are internal costs and (ii) consulting expenses.

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

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

Previous wording

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:

Current wording

and development, we cannot reasonably estimate or know:

Previous wording

For the three months ended March 31, 2025, we had a net loss of $3.7 million, or $0.36 per share of basic and diluted common stock, compared to a net loss of $6.7 million, or $1.32 per share of basic and diluted common stock for the three months ended March 31, 2024, primarily due to the factors described above.

Current 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.

Previous wording

Our total operating expenses and loss from operations for the three months ended March 31, 2025 were $3.9 million, a decrease of $3.0 million, or 43.5%, compared to the three months ended March 31, 2024. This decrease was attributable to lower R&D and general and administrative expenses for the three months ended March 31, 2025. Our R&D expenses were $2.3 million for the three months ended March 31, 2025, a decrease of $2.6 million, or 52.5%, compared to the three months ended March 31, 2024. Ourgeneral and administrative expenses were $1.6 million for the three months ended March 31, 2025, a decrease of $0.4 million, or 21.1%, compared to the three months ended March 31, 2024.

Current 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.

Previous wording

The $2.6 million decrease in R&D expenses reflects decreased R&D activities related to the Phase 2a clinical trial for DA-1241 and increased activities related to the Phase 1 trial for DA-1726 as compared to the three months ended March 31, 2024. Specifically, the decrease in R&D expenses was primarily attributable to (i) $2.9 million in lower direct R&D expenses related to DA-1241 product development and (ii) $0.2 million in lower direct other R&D costs. These decreases were partially offset by (i) $0.5 million in higher direct R&D expenses related to DA-1726 product development and (ii) $0.1 million in higher indirect R&D expenses related to employee compensation and benefits. Included in direct R&D costs were expenses totaling $1.1 million and $0.2 million for the three months ended March 31, 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 $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).

Previous wording

The $0.4 million decrease ingeneral and administrative expenses was primarily attributable to (i) $0.4 million in lower consulting expenditures and (ii) $0.2 million in lower other G&A expenses. These decreases were partially offset by $0.2 million in higher employee compensation and benefits.

Current 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.

Previous wording

As reflected in the condensed consolidated financial statements, we had $11.2 million in cash as of March 31, 2025. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $139.5 million as of March 31, 2025. We have incurred a net loss of $3.7 million and net cash used in operating activities of $4.8 million for the three months ended March 31, 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 $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.

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 A and 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 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.

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, 2025, we had cash totaling $11.2 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 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

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

Previous wording

Net cash used in operating activities was $4.8 million for the three months ended March 31, 2025 and consisted of net loss of $3.7 million and net cash used in change 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. Net cash used in operating activities was $6.4 million for the three months ended March 31, 2024 and consisted of net loss of $6.7 million, partially offset by non-cash charges totaling $0.2 million, which was primarily related to stock-

Current 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.

Previous wording

We had no investing activities for the three months ended March 31, 2025. Net cash used in investing activities was less than $0.1 million for the three months ended March 31, 2024, related to the purchase of property and equipment.

Current 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.

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 liabilities. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.

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 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