MetaVia Inc.: Form 10-Q for the period ended Jun 30, 2026

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.

Overview

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

• Vanoglipel is a novel G-Protein-Coupled Receptor 119 (“GPR119”) agonist with development optionality as a standalone or combination therapy for both MASH and Type 2 Diabetes Mellitus (“T2DM”). Agonism of GPR119 in the gut promotes the release of key gut peptides, glucagon-like peptide 1 (“GLP-1”), glucagon-dependent insulinotropic polypeptide receptor, and peptide YY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. Vanoglipel has demonstrated beneficial effects on glucose, lipid profile and liver inflammation, as demonstrated during in-vivo preclinical studies.
• DA-1726 is a novel oxyntomodulin analog agonist functioning as a GLP-1 receptor (“GLP1R”) and glucagon receptor (“GCGR”) dual agonist for the treatment of obesity that is designed to be administered once weekly subcutaneously. With the activation of the dual agonist, weight loss may be achieved by GLP1R reducing appetite while GCGR increases energy expenditure.

While we primarily focus our financial resources and management’s attention on the development of vanoglipel 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 includes preclinical developments and clinical trials, and raising capital. Our activities are subject to significant risks and uncertainties, such as failing to secure additional funding before sustainable revenues and profit from operations are achieved. For more information on our business and product candidates, see “Part I, Item 1. Business” in our 2025 Form 10-K.

Vanoglipel

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.

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.

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

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-Ks dated January 5, 2026, March 18, 2026, April 10, 2026, May 11, 2026, May 18, 2026, May 27, 2026, June 8, 2026 and July 9, 2026.

Recent developments

• April 2026: Dosed the first patient in the Phase 1, Part 3 clinical trial for DA-1726 in obese, otherwise healthy adults using one-step titration to 48 mg and two-step titration to 64 mg to safely achieve higher target doses and optimize tolerability.
• May 2026: Presented additional data from the 48 mg Phase 1 clinical trial of DA-1726 at the European Association for the Study of the Liver Congress 2026 (EASL 2026), which was held May 27-30 in Barcelona, Spain, demonstrating up to 9.1% mean body weight reduction without evidence of plateau and exploratory improvements in liver-related biomarkers, supporting the potential of DA-1726 in obesity and MASH.
• June 2026: Presented new late-breaking data at the American Diabetes Association’s (ADA) 2026 Scientific Sessions, which was held in New Orleans, Louisiana, United States, supporting DA-1726's differentiated obesity profile and demonstrating the combination potential of vanoglipel with resmetirom in MASH and metformin in type 2 diabetes.
• July 2026: Announced the completion of dose titration in the 16-week, Phase 1 Part 3 study of DA-1726, with all active patients successfully reaching the highest planned dose levels of 48 mg and 64 mg.

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.

Results of operations

Three months ended June 30, 2026 compared to three months ended June 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 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&D expenses for 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.

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

The $1.2 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 June 30, 2026 as compared to the corresponding period in 2025. Specifically, the increase in R&D expenses was mainly attributable to higher direct R&D expenses related to DA-1726 product development. Included in direct R&D costs were expenses totaling $0.2 million and $1.3 million for the three 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).

The approximately $0.1 million decrease in G&A expenses was primarily attributable to lower legal and professional fees.

Total other income

Our total other income for the three 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.

Provision for income taxes

Our provision for income taxes and effective tax rate for the three months ended June 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 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 for the corresponding period in 2025, primarily due to the factors described above.

Six months ended June 30, 2026 compared to six months ended June 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 six months ended June 30, 2026 were $9.4 million, an increase of approximately $1.2 million, or 14.9%, compared to the corresponding period in 2025. This increase was attributable to higher R&D and G&A expenses for the six months ended June 30, 2026. Our R&D expenses were $5.6 million for the six months ended June 30, 2026, an increase of $0.9 million, or 20.1%, compared to the corresponding period in 2025. Our G&A expenses were $3.8 million for the six months ended June 30, 2026, an increase of approximately $0.3 million, or 8.2%, compared to the corresponding period in 2025.

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

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).

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.

Total other income

Our total other income for the six months ended June 30, 2026 was $0.3 million, a decrease of approximately $0.3 million, or 48.0%, compared to the corresponding period in 2025. This decrease was attributable to (i) approximately $0.1 million in lower gain from change in fair value of warrant liabilities due to the impact of our common stock’s decline in stock price and (ii) approximately $0.1 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 six months ended June 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 six months ended June 30, 2026, we had a net loss of $9.1 million, or $1.69 per share of basic and diluted common stock, compared to a net loss of $7.7 million, or $6.59 per share of basic and diluted common stock for the corresponding period in 2025, primarily due to the factors described above.

Going concern

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.

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 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 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.

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 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. 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 three and six months ended June 30, 2026:

23

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”) 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.

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.

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.

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 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.

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.

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

May 2025 private placement offering, partially offset by the payment of $0.5 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.

Evaluation of disclosure controls and procedures

As required by Rules 13a-15(b) and 15d-15(b) under Section 21E of the Exchange Act, our management, with the participation of our principal executive officer (“PEO”) and principal financial officer (“PFO”), evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Report. Based upon that evaluation, our PEO and PFO concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Report.

Inherent limitations of disclosure controls and procedures

Our management, including our PEO and PFO, does not expect that our disclosure controls and procedures will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate.

Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Changes in internal control over financial reporting

There have been no changes in our internal control over financial reporting during the quarter ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Our business, financial condition and operating results can be affected by a number of factors, whether currently known or unknown, including but not limited to those described under the heading “Risk Factors” in Part I, Item 1A of the 2025 Form 10-K, any one or more of which could, directly or indirectly, cause our actual financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating results. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating results and stock price. There have been no material changes to our risk factors since the 2025 Form 10-K.