UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
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METAVIA INC.
Table of Contents
Special Note Regarding Forward-Looking Statements | 2 | |
3 | ||
3 | ||
Condensed Consolidated Balance Sheets as of September 30, 2025 (Unaudited) and December 31, 2024 | 3 | |
4 | ||
5 | ||
6 | ||
Notes to the Condensed Consolidated Financial Statements (Unaudited) | 7 | |
Management’s Discussion and Analysis of Financial Condition and Results of Operations | 16 | |
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1
Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025 (this “Report”) to “we,” “us,” “the Company,” “MetaVia,” “the Registrant” and “our” refer to MetaVia Inc. and its subsidiaries.
Special Note Regarding Forward-Looking Statements
This Report contains “forward-looking statements” within the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation, our expectations regarding our ability to execute our commercial strategy; our expectations regarding the sufficiency of our existing cash on hand to fund our operations; the timeline for regulatory submissions, regulatory steps and potential regulatory approval of our current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co., Ltd., a related party (“Dong-A ST”), including the impact on our future financial and operating results; the ability to integrate the product candidates into our business in a timely and cost-efficient manner; the cooperation of our contract manufacturers, clinical study partners and others involved in the development of our current and future product candidates; our ability to initiate clinical trials on a timely basis; our planned clinical trials and our ability to recruit subjects for our clinical trials; the costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the changes in applicable laws or regulations; and the effects of changes to our stock price on the terms of the license agreement and any future fundraising and other risks and uncertainties described in this Report and in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (“2024 Form 10-K”), our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025 (the “Q1 2025 Form 10-Q”), and in our other filings with the Securities and Exchange Commission (the “SEC”).
Forward-looking statements are based on management’s current expectations and assumptions about future events, which are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict. These statements may be identified by words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. In addition, statements that “we believe,” “we expect,” “we anticipate” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Report and management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. We undertake no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results or expectations, except as required by law.
We operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for us to predict all risk factors and uncertainties. We may not achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation, the possibility that regulatory authorities do not accept our applications or approve the marketing of our products, the possibility we may be unable to raise the funds necessary for the development and commercialization of our products, and those described in this Report and our other filings with the SEC.
2
Part I - Financial Information
Item 1.Financial Statements
MetaVia Inc.
Condensed Consolidated Balance Sheets
(In thousands, except per share amounts)
As of | ||||||
September 30, 2025 | December 31, 2024 | |||||
(Unaudited) | ||||||
Assets | ||||||
Current assets | ||||||
Cash | $ | | $ | | ||
Prepaid expenses and other current assets | | | ||||
Total current assets |
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Property and equipment, net |
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Right-of-use asset | | | ||||
Other assets | | | ||||
Total assets | $ | | $ | | ||
Liabilities and stockholders’ equity | ||||||
Current liabilities | ||||||
Accounts payable | $ | | $ | | ||
Clinical trial accrued liabilities | | | ||||
Accrued expenses and other current liabilities |
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Warrant liabilities | | | ||||
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Lease liability, short-term | | | ||||
Total current liabilities |
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Lease liability, long-term | — | | ||||
Total liabilities |
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Commitments and contingencies | ||||||
Stockholders’ equity | ||||||
Preferred stock, $ | ||||||
Common stock, $ |
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Additional paid–in capital |
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Accumulated deficit |
| ( |
| ( | ||
Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | | ||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
MetaVia Inc.
Condensed Consolidated Statements of Operations
(Unaudited - In thousands, except share and per share amounts)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||
Operating expenses |
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Research and development | $ | | $ | | $ | | $ | | ||||
General and administrative | | | | | ||||||||
Total operating expenses |
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Loss from operations |
| ( |
| ( |
| ( |
| ( | ||||
Other income (expense) | ||||||||||||
(Loss) gain from change in fair value of warrant liabilities | ( | | | | ||||||||
Interest income, net | | | | | ||||||||
Total other income | | | | | ||||||||
Loss before income taxes | ( | ( | ( | ( | ||||||||
Provision for income taxes | |
| | |
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Net loss and comprehensive net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Loss per share of common stock, basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Weighted average shares of common stock, basic and diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
MetaVia Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Equity
(Unaudited - In thousands)
Additional | |||||||||||||
Common Stock | Paid-In | Accumulated | Total | ||||||||||
Shares |
| Amount |
| Capital |
| Deficit |
| Equity | |||||
As of January 1, 2024 | | $ | | $ | | $ | ( | $ | | ||||
Stock-based compensation | — | — | | — | | ||||||||
Net loss | — | — | — | ( | ( | ||||||||
As of March 31, 2024 | | $ | | $ | | $ | ( | $ | | ||||
Issuance of common stock and warrants (Pre-funded, Series A and Series B), net of issuance costs of $ | | | | — | | ||||||||
Issuance of Placement Agent warrants | — | — | | — | | ||||||||
Issuance of common stock for vested restricted stock units | | — | — | — | — | ||||||||
Stock–based compensation | — | — | | — | | ||||||||
Net loss | — | — | — | ( | ( | ||||||||
As of June 30, 2024 | | $ | | $ | | $ | ( | $ | | ||||
Issuance costs in connection with the issuance of common stock and warrants (Pre-funded, Series A and Series B) | — | — | ( | — | ( | ||||||||
Issuance of common stock from exercise of warrants | | | — | — | | ||||||||
Issuance of common stock for vested restricted stock units | | — | ( | — | ( | ||||||||
Stock-based compensation | — | — | | — | | ||||||||
Net loss | — | — | — | ( | ( | ||||||||
As of September 30, 2024 | | $ | | $ | | $ | ( | $ | | ||||
As of January 1, 2025 | | $ | | $ | | $ | ( | $ | | ||||
Issuance of common stock for vested restricted stock units | | — | ( | — | ( | ||||||||
Stock-based compensation | — | — | | — | | ||||||||
Net loss | — | — | — | ( | ( | ||||||||
As of March 31, 2025 | | $ | | $ | | $ | ( | $ | | ||||
Issuance of common stock and pre-funded warrants, net of issuance costs of $ | | | | — | | ||||||||
Issuance of common stock for exercise of warrants | | | — | — | | ||||||||
Issuance of common stock for vested restricted stock units | | — | — | — | — | ||||||||
Stock-based compensation | — | — | | — | | ||||||||
Net loss | — | — | — | ( | ( | ||||||||
As of June 30, 2025 | | $ | | $ | | $ | ( | $ | | ||||
Issuance costs in connection with the issuance of common stock and pre-funded warrants | — | — | ( | — | ( | ||||||||
Issuance of common stock for vested restricted stock units | | — | — | — | — | ||||||||
Stock-based compensation | — | — | | — | | ||||||||
Net loss | — | — | — | ( | ( | ||||||||
As of September 30, 2025 | | $ | | $ | | $ | ( | $ | | ||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
MetaVia Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited - In thousands)
Nine Months Ended September 30, | ||||||
2025 | 2024 | |||||
Operating activities | ||||||
Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities | ||||||
Stock-based compensation |
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Non-cash lease charge | — | | ||||
Depreciation |
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Gain from change in fair value of warrant liabilities | ( | ( | ||||
Change in operating assets and liabilities | ||||||
Prepaid expenses and other assets |
| ( |
| ( | ||
Accounts payable |
| ( |
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Accrued and other liabilities |
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Net cash used in operating activities |
| ( |
| ( | ||
Investing activities | ||||||
Purchases of property and equipment |
| ( |
| ( | ||
Net cash used in investing activities |
| ( |
| ( | ||
Financing activities | ||||||
Proceeds from issuance of common stock and pre-funded warrants | | | ||||
Payments of issuance costs | ( | ( | ||||
Proceeds from exercise of warrants | | — | ||||
Payment of employee withholding taxes related to shares withheld from issuance for vested restricted stock units | ( | ( | ||||
Net cash provided by financing activities |
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Net decrease in cash |
| ( |
| ( | ||
Cash at beginning of period |
| |
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Cash at end of period | $ | | $ | | ||
Supplemental non-cash investing and financing transactions | ||||||
Unpaid issuance costs | $ | — | $ | | ||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
1.Business, basis of presentation, new accounting standards and summary of significant accounting policies
General
MetaVia Inc. (the “Company”), a Delaware corporation, and its subsidiaries are referred to collectively in these notes to the condensed consolidated financial statements of the Company as “MetaVia,” “we,” “our” and “us.” 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 of metabolic dysfunction-associated steatohepatitis (“MASH”) and obesity, Vanoglipel (DA-1241) and DA-1726.
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.
Our operations have consisted principally of performing research and development (“R&D”) activities, which include preclinical developments and clinical trials, and raising capital. Our activities are subject to significant risks and uncertainties, including failing to secure additional funding before sustainable revenues and profit from operations are achieved.
Going concern
As reflected in the condensed consolidated financial statements, we had $
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.
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 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.
A.Basis of presentation
We prepared the condensed consolidated financial statements following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“GAAP”) for complete financial statements can be condensed or omitted. However, except as disclosed herein, there has been no material change in the information disclosed in the notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (“2024 Form 10-K”).
7
Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these condensed consolidated financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the condensed consolidated financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in the condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in our 2024 Form 10-K. Certain amounts in the condensed consolidated financial statements and accompanying notes may not add up due to rounding, and all percentages have been calculated using unrounded amounts.
B.New accounting standards
Adoption of new accounting standards
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures to improve the transparency of income tax disclosures by amending the required rate reconciliation disclosures as well as requiring disclosure of income taxes paid disaggregated by jurisdiction. As amended, the rate reconciliation disclosure will be required to be presented in both percentages and reporting currency amounts, with consistent categories and greater disaggregation of information. This ASU also includes amendments intended to improve the effectiveness of income tax disclosures and eliminate certain existing disclosure requirements related to uncertain tax positions and unrecognized deferred tax liabilities. This ASU is effective for annual periods beginning after December 15, 2024. We do not expect the adoption of ASU 2023-09 to have a significant impact on our consolidated financial statements and accompanying notes for the year ended December 31, 2025.
Accounting standards issued but not yet adopted
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses to improve financial reporting by requiring that public business entities disclose additional information about specific expense categories in the notes to the consolidated financial statements at interim and annual reporting periods. The amendments in this ASU do not change or remove current expense disclosure requirements; however, the amendments affect where such information appears in the notes to the consolidated financial statements because entities are required to include certain current disclosures in the same tabular format disclosure as the other disaggregation requirements in the amendments. In January 2025, the FASB issued ASU 2025-01, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. This ASU is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods within annual reporting period beginning after December 15, 2027. Early adoption is permitted. We are currently evaluating the impact of adopting this ASU to our notes to the consolidated financial statements and processes.
Other recently issued accounting standards not yet adopted by us are not expected, upon adoption, to have a material impact on our condensed consolidated financial statements.
C.Estimates and assumptions
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 clinical trial costs and accruals, classification of warrants as derivative liability or equity, 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.
D.Significant accounting policies
Our significant accounting policies are described in “Note 1. Business, basis of presentation, new accounting standards and summary of significant accounting policies” in the audited consolidated financial statements and notes thereto for the year
8
ended December 31, 2024, which is included in our 2024 Form 10-K. Except as disclosed below, there have been no material changes to the Company’s significant accounting policies.
Segment reporting
We manage and operate as
2. Prepaid expenses and other current assets
Prepaid expenses and other current assets consist of the following (in thousands):
As of | ||||||
September 30, 2025 | December 31, 2024 | |||||
Insurance | $ | | $ | | ||
Deposits | | | ||||
Deferred expenses | | — | ||||
Prepaid non-income state taxes | | — | ||||
Prepaid clinical trial expenses | | — | ||||
Other prepaid expenses |
| |
| | ||
Total | $ | | $ | | ||
3. Property and equipment, net
Property and equipment, net consist of the following (in thousands):
As of | ||||||
September 30, 2025 | December 31, 2024 | |||||
Office equipment | $ | | $ | | ||
Less accumulated depreciation |
| ( |
| ( | ||
Property and equipment, net | $ | | $ | | ||
We recorded depreciation expense of $
4. Current liabilities
Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consist of the following (in thousands):
As of | ||||||
September 30, 2025 | December 31, 2024 | |||||
Employee related costs | $ | | $ | | ||
Professional service fees | | | ||||
Other |
| |
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Total | $ | | $ | | ||
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Warrant liabilities
Changes to our warrant liabilities are summarized as follows (in thousands):
Total | |||
As of January 1, 2024 | $ | | |
( | |||
As of September 30, 2024 | $ | | |
As of January 1, 2025 | $ | | |
( | |||
As of September 30, 2025 | $ | | |
Our warrant liabilities relate to the 2022 Series B warrants, which were issued in November 2022. These warrants are considered to be derivative instruments; accordingly, we recorded their estimated fair value as warrant liabilities. We estimated the fair value of these warrants using the trading market price of our common stock due to a cashless exercise provision of these warrants whereby
5.Related party
We entered into a license agreement with Dong-A ST Co., Ltd. (“Dong-A ST”) pursuant to which we received an exclusive global license (except for the territory of the Republic of Korea) for two proprietary compounds for specified indications (the “2022 License Agreement”) upon meeting certain financing milestones. The 2022 License Agreement covers the rights to Vanoglipel (DA-1241) for treatment of MASH and DA-1726 for treatment of obesity and MASH. The 2022 License Agreement also provides that we may develop Vanoglipel (DA-1241) for the treatment of type 2 diabetes mellitus.
In connection with the 2022 License Agreement, we entered into a shared services agreement with Dong-A ST (the “Shared Services Agreement”), relating to Vanoglipel (DA-1241) and DA-1726, pursuant to which Dong-A ST may provide technical support, preclinical development, and clinical trial support services on terms and conditions acceptable to both parties. In addition, the Shared Services Agreement provides that Dong-A ST will manufacture all of our clinical requirements of Vanoglipel (DA-1241) and DA-1726 under the terms provided in the Shared Services Agreement.
We incurred R&D expenses of $
For additional information on the 2022 License Agreement, the Shared Services Agreement and other agreements with Dong-A ST, refer to “Note 5. Related party” in the audited consolidated financial statements and notes thereto for the year ended December 31, 2024, which is included in our 2024 Form 10-K.
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6.Stockholders’ equity
Private Placement
In May 2025, we closed on a private placement offering with Dong-A ST, a related party, and Dong-A Socio Holdings Co., Ltd., an affiliate company of Dong-A ST, and received net proceeds of $
Each pre-funded warrant had an exercise price of $
Warrants
The following tables summarize our outstanding warrants:
Shares of Common Stock Issuable | ||||||||
for Outstanding Warrants | ||||||||
As of | Exercise | Expiration | ||||||
Warrant Issuance | September 30, 2025 | December 31, 2024 | Price | Date | ||||
July 2018 (1) | | | $ | July 2028 | ||||
April 2020 (1) | — | | $ | April 2025 | ||||
January 2021 (1) | | | $ | July 2026 | ||||
October 2021 (1) | — | | $ | April 2025 | ||||
November 2022 Series B (2) | | | $ | December 2027 | ||||
June 2024 Placement Agent (3) | | | $ | July 2026 | ||||
June 2024 Pre-Funded (4) | — | | $ | No expiration date | ||||
June 2024 Series A (5) | — | | $ | June 2025 | ||||
June 2024 Series B (6) | | | $ | September 2029 (latest date) | ||||
Total | | | ||||||
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Stock-based compensation
Stock-based compensation expense was included in general and administrative operating expense and research and development operating expense as follows (in thousands):
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||
General and administrative | $ | | $ | | $ | | $ | | ||||
Research and development | | | | | ||||||||
Total stock-based compensation | $ | | $ | | $ | | $ | | ||||
Stock-based award plans
Our Amended and Restated 2022 Equity Incentive Plan (the “2022 Plan”) provides for an automatic increase on January 1st of each year for a period of
Remaining shares of | ||||||
Stock | common stock available | |||||
Plan Name | Options | RSUs | for future issuance | |||
2019 Equity Incentive Plan | | — | — | |||
2021 Inducement Plan | — | — | | |||
2022 Plan | | | | |||
Total | | | |
For stock-based awards granted under our stock-based award plans as of September 30, 2025, unrecognized stock-based compensation costs totaled $
Restricted Stock Units
The following table summarizes the status of our outstanding restricted stock units (“RSUs”) and related transactions for the period presented as well as our vested and deferred release RSUs as of the beginning of the 2025 and September 30, 2025 (in thousands, except share and per share amounts):
Outstanding | Vested and Deferred Release | |||||||||||||||
Shares of | Average | Shares of | Average | |||||||||||||
Common Stock | Grant Date | Aggregate | Common Stock | Grant Date | Aggregate | |||||||||||
Issuable | Fair Value | Fair | Issuable | Fair Value | Intrinsic | |||||||||||
for RSUs | Price | Value | for RSUs | Price | Value | |||||||||||
As of January 1, 2025 | | | | | | | ||||||||||
Granted | | | ||||||||||||||
Forfeited | ( | | ||||||||||||||
Vested and released | ( | | | |||||||||||||
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As of September 30, 2025 | | $ | | $ | | | $ | | $ | |
Stock options
The following table summarizes the status of our outstanding and exercisable options and related transactions for the period presented (in thousands, except share and per share amounts):
Outstanding | Exercisable | |||||||||||||
Shares of | Weighted | Shares of | Weighted | |||||||||||
Common | Weighted | Average | Common | Weighted | Average | |||||||||
Stock | Average | Remaining | Stock | Average | Remaining | |||||||||
Issuable | Exercise | Contractual | Issuable | Exercise | Contractual | |||||||||
for Options | Price | Term (years) | for Options | Price | Term (years) | |||||||||
As of January 1, 2025 | | $ | | | $ | | ||||||||
Vested | | | ||||||||||||
As of September 30, 2025 | | $ | | | $ | | ||||||||
7.Significant segment expenses and loss before income taxes
The following table sets forth the significant segment expenses for our
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||
Operating expenses |
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|
|
| ||||||||
Research and development | ||||||||||||
Direct expenses - Vanoglipel (DA-1241) | $ | | $ | | $ | | $ | | ||||
Direct expenses - DA-1726 | | | | | ||||||||
Direct expenses - Other R&D costs (credits) (1) | | ( | | | ||||||||
Indirect expenses - employee compensation and benefits | | | | | ||||||||
Indirect expenses - consulting expenses | | | | | ||||||||
Total research and development | | | | | ||||||||
General and administrative | ||||||||||||
Legal and professional fees | | | | | ||||||||
Consulting | | | | | ||||||||
Employee compensation and benefits | | | | | ||||||||
Other (2) | | | | | ||||||||
Total general and administrative | | | | | ||||||||
Total operating expenses | | | | | ||||||||
Loss from operations | ( | ( | ( | ( | ||||||||
Total other income | | | | | ||||||||
Loss before income taxes | $ | ( | $ | ( | $ | ( | $ | ( | ||||
(1)Other R&D costs (credits) include clinical, non-clinical and preclinical services or other R&D expenses that are not attributable to a single product candidate.
(2)Other general and administrative expenses include insurance, software license fees, non-income state taxes, lease rental expenses and other general and administrative expenditures.
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8.Income taxes
We do not expect to pay any significant federal or state income taxes as a result of (i) the losses recorded during the nine months ended September 30, 2025, (ii) additional losses expected for the remainder of 2025, or (iii) net operating loss carry forwards from prior years.
We recorded a full valuation allowance of the net operating losses for the three and nine months ended September 30, 2025 and 2024. Accordingly, there were
In July 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted. The OBBBA makes permanent key elements of the Tax Cuts and Jobs Act of 2017, including 100% bonus depreciation, domestic research cost expensing and the business interest expense limitation, among other tax changes. Many of the tax provisions of the OBBBA are designed to accelerate tax deductions, and the new legislation has multiple effective dates, with certain provisions effective in 2025 and others in the future. We are currently evaluating the impact of the tax provisions of the OBBBA on our consolidated financial statements and accompanying notes.
9.Loss per share of common stock
The following table sets forth the computation of basic and diluted loss per share of common stock (in thousands, except share and per share amounts):
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||
Numerator: | ||||||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Denominator: | ||||||||||||
Weighted average shares of common stock, basic | ||||||||||||
Effect of dilutive securities | — | — | — | — | ||||||||
Weighted average shares of common stock, diluted | ||||||||||||
Loss per share of common stock, basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( | ||||
For each of the periods presented in the above table, our basic weighted average shares of common stock include any outstanding (i) Series B warrants issued in November 2022, (ii) pre-funded warrants in June 2024 and May 2025 and (iii) vested RSUs in which their release was deferred.
Since we reported a net loss for the three and nine months ended September 30, 2025 and 2024, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities. Therefore, our basic and diluted loss per share of common stock and our basic and diluted weighted average shares of common stock are the same for the three and nine months ended September 30, 2025 and 2024.
The following table sets forth the potentially dilutive securities that were not included in the calculation of diluted earnings per share of common stock as of and for the nine months ended September 30, 2025 and 2024:
As of | ||||
| September 30, 2025 | December 31, 2024 | ||
Stock options | | | ||
RSUs | | | ||
Warrants | | | ||
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10.Fair value of financial instruments
Fair value is a market-based measurement, not an entity specific measurement and is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three-level hierarchy:
Level 1: | Unadjusted quoted prices for identical assets or liabilities in active markets; |
Level 2: | Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, whether directly or indirectly, for substantially the full term of the asset or liability; and |
Level 3: Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.
The following table sets forth our financial assets and liabilities, subject to fair value measurements on a recurring basis, by level within the fair value hierarchy (in thousands):
As of September 30, 2025 | As of December 31, 2024 | |||||||||||||||||||||||
Description |
| Total |
| Level 1 |
| Level 2 |
| Level 3 |
| Total |
| Level 1 |
| Level 2 |
| Level 3 | ||||||||
Liabilities: | ||||||||||||||||||||||||
Warrant liabilities | $ | | $ | — | $ | | $ | — | $ | | $ | — | $ | | $ | — | ||||||||
Total | $ | | $ | — | $ | | $ | — | $ | | $ | — | $ | | $ | — | ||||||||
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Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and related notes included elsewhere in this Report and the audited financial statements and related notes for the fiscal year ended December 31, 2024 included in our 2024 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. MetaVia has two ongoing programs focused primarily on the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and obesity.
| ● | Vanoglipel (DA-1241) is a novel G-Protein-Coupled Receptor 119 (“GPR119”) agonist with development optionality as a standalone and/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 (DA-1241) has demonstrated beneficial effects on glucose, lipid profile and liver inflammation, as demonstrated during in-vivo preclinical studies. |
| ● | DA-1726 is a novel oxyntomodulin (“OXM”) 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 (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.
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 2024 Form 10-K.
Vanoglipel (DA-1241)
We are currently finalizing the Clinical Study Report on a Phase 2a clinical trial in the United States (“U.S.”). MASH Phase 2a is a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel arm clinical trial to establish safety and an early signal of efficacy in MASH as a next-generation competitive oral agent while we follow the trend for T2DM.
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.
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.
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DA-1726
We are currently conducting a Phase 1 trial in the U.S. The Phase 1 trial, a first-in-human trial, is a randomized, placebo-controlled, double-blind, two-part study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects.
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 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.
In November 2025, we presented new Phase 1 and pre-clinical data on DA-1726 in two poster presentations at ObesityWeek® 2025.
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, July 9, 2025, and August 6, 2025.
Recent developments
| ● | July 2025: Dosed the first patient in the 48 mg, MAD cohort of the Phase 1 clinical trial of DA-1726, a novel, dual OXM analog agonist that functions as a GLP1R and GCGR, for the treatment of obesity to further explore the maximum tolerated dose. Top-line data is expected in the fourth quarter of 2025. |
| ● | August 2025: Announced a research collaboration with Syntekabio, Inc., a leading artificial intelligence driven drug discovery company, to identify additional disease targets and optimize the therapeutic profile of Vanoglipel (DA-1241), MetaVia’s novel oral G-Protein-Coupled Receptor 119 (GPR119) agonist. |
| ● | August 2025: Administered the fifth dose for the first patient in the 48 mg, MAD cohort of the Phase 1 clinical trial of DA-1726. |
| ● | November 2025: Presented new Phase 1 and pre-clinical data on DA-1726 in two poster presentations at ObesityWeek® 2025. The Phase 1 data demonstrated favorable safety and tolerability, a newly characterized 32 mg pharmacokinetic (PK) profile supporting once-weekly dosing, and meaningful reductions in body weight and waist circumference following four weeks of treatment. Additionally, in a diet-induced obesity (DIO) mouse model, DA-1726 achieved comparable weight loss to pemvidutide with superior lipid-lowering efficacy. |
Key operating information
Except for the following disclosure and the financial amounts for the presented periods in this Report (see financial amounts in the below results of operations and the condensed consolidated balance sheets included elsewhere in this Report), there have been no material changes to our key operating information since December 31, 2024. Refer to our 2024 Form 10-K for a complete discussion of our key operating information.
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Research and development expenses
R&D expenses consist primarily of costs incurred in connection with the development of our product candidates. These expenses include:
Direct costs
| ● | expenses incurred in connection with the clinical development of our product candidates, including under agreements with third parties, such as clinical research organizations (“CROs”) and consultants; |
| ● | the cost of manufacturing and storing drug products for use in our preclinical studies and clinical trials, including under agreements with third parties, such as consultants and Clinical Manufacturing Organizations (“CMOs”); |
| ● | costs related to compliance with regulatory requirements; and |
| ● | payments made under third-party licensing agreements including the Shared Services Agreement with Dong-A ST (related party). |
Indirect costs
| ● | employee-related expenses, including salaries, related benefits and stock-based compensation, for employees engaged in research and development functions; and |
| ● | consulting and other expenses not directly tied to a product candidate. |
We recognize external development costs based on an evaluation of the progress toward completion of specific tasks using information provided to us by our service providers. This process involves reviewing contracts and purchase orders, communicating with our clinical research staff to identify services that have been performed on our behalf, and estimating the level of service provided and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense when the goods have been delivered or the services have been performed, or when it is no longer expected that the goods will be delivered, or the services rendered.
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.
Clinical development activities are central to our business model. We do not believe that our historical costs are indicative of the future costs associated with these programs, nor do they represent the costs of future programs we may initiate. Product candidates in later stages of clinical development generally have higher development costs than those in preclinical development or in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We have some control over the timing of these expenses, but costs may be difficult to control once clinical trials have commenced.
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:
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| • | the timing and progress of preclinical and clinical development activities; |
| • | the number and scope of preclinical and clinical programs that we decide to pursue; |
| • | our ability to maintain our current development programs and to establish new ones; |
| • | establishing an appropriate safety profile with IND-enabling studies; |
| • | successful patient enrollment in, and the initiation and completion of, clinical trials; |
| • | the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority; |
| • | the receipt of regulatory approvals from applicable regulatory authorities; |
| • | the timing, receipt and terms of any marketing approvals from applicable regulatory authorities; |
| • | our ability to establish new licensing or collaboration arrangements; |
| • | establishing agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if any of our product candidates is approved; |
| • | development and timely delivery of clinical-grade and commercial-grade drug formulations that can be used in our clinical trials and for commercial launch; |
| • | obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights; |
| • | launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others; |
| • | maintaining a continued acceptable safety profile of the product candidates following commercialization; or |
| • | the effect of competing technological and market developments. |
A change in the outcome of any of these variables with respect to the development of our product candidates could significantly change the costs and timing associated with the development of that product candidate.
Results of operations
Three months ended September 30, 2025 compared to three months ended September 30, 2024
The following table summarizes our results of operations (in thousands, except share and per share amounts):
Three Months Ended September 30, | ||||||
| 2025 | 2024 | ||||
Operating expenses | ||||||
Research and development | $ | 1,914 | $ | 4,517 | ||
General and administrative | 1,561 | 1,742 | ||||
Total operating expenses |
| 3,475 |
| 6,259 | ||
Loss from operations |
| (3,475) |
| (6,259) | ||
Other income (expense) | ||||||
(Loss) gain from change in fair value of warrant liabilities | (53) | 297 | ||||
Interest income, net | 151 | 310 | ||||
Total other income | 98 | 607 | ||||
Loss before income taxes | (3,377) | (5,652) | ||||
Provision for income taxes | — | — | ||||
Net loss | $ | (3,377) | $ | (5,652) | ||
Loss per share of common stock, basic and diluted | $ | (0.14) | $ | (0.55) | ||
Weighted average shares of common stock, basic and diluted |
| 24,415,876 |
| 10,214,087 | ||
Total operating expenses and loss from operations
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. Our general 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.
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The following table summarizes our R&D expenses for the three months ended September 30, 2025 and 2024 (in thousands):
Three Months Ended September 30, | ||||||
| 2025 | 2024 | ||||
Direct costs | ||||||
Vanoglipel (DA-1241) | $ | 190 | $ | 2,544 | ||
DA-1726 | 1,080 | 1,501 | ||||
Other R&D costs (credits) | 52 | (73) | ||||
Indirect costs | ||||||
Employee compensation and benefits | 351 | 369 | ||||
Consulting expenses | 241 | 176 | ||||
Total research and development | $ | 1,914 | $ | 4,517 | ||
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).
The $0.2 million decrease in general and administrative expenses was primarily attributable to (i) $0.1 million in lower consulting expenditures, (ii) $0.1 million in lower employee compensation and benefits, and (iii) $0.1 million in lower other general and administrative expenses. These decreases were partially offset by $0.1 million in higher legal and professional fees.
Total other income
Our total other income for the three 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.
Provision for income taxes
Our effective tax rate for the three 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.
Net loss
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.
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Nine months ended September 30, 2025 compared to nine months ended September 30, 2024
The following table summarizes our results of operations (in thousands, except share and per share amounts):
Nine Months Ended September 30, | ||||||
| 2025 | 2024 | ||||
Operating expenses | ||||||
Research and development | $ | 6,561 | $ | 17,495 | ||
General and administrative | 5,101 | 5,729 | ||||
Total operating expenses |
| 11,662 |
| 23,224 | ||
Loss from operations |
| (11,662) |
| (23,224) | ||
Other income | ||||||
Gain from change in fair value of warrant liabilities | 194 | 94 | ||||
Interest income, net | 425 | 711 | ||||
Total other income | 619 | 805 | ||||
Loss before income taxes | (11,043) | (22,419) | ||||
Provision for income taxes | — | — | ||||
Net loss | $ | (11,043) | $ | (22,419) | ||
Loss per share of common stock, basic and diluted | $ | (0.63) | $ | (3.24) | ||
Weighted average shares of common stock, basic and diluted |
| 17,517,322 |
| 6,922,338 | ||
Total operating expenses and loss from operations
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. Our general 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.
The following table summarizes our R&D expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Nine Months Ended September 30, | |||||||||
| 2025 | 2024 | |||||||
Direct costs | |||||||||
Vanoglipel (DA-1241) | $ | 758 | $ | 8,402 | |||||
DA-1726 | 4,088 | 7,435 | |||||||
Other R&D costs | 107 | 255 | |||||||
Indirect costs | |||||||||
Employee compensation and benefits | 1,301 | 1,161 | |||||||
Consulting expenses | 307 | 242 | |||||||
Total research and development | $ | 6,561 | $ | 17,495 | |||||
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).
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The $0.6 million decrease in general 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.
Total other income
Our total other income for the nine 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.
Provision for income taxes
Our effective tax rate for the nine 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.
Net loss
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.
Going concern
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.
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.
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 condensed consolidated financial statements have been prepared assuming that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities in the normal course of business.
Liquidity and capital resources
Our primary use of cash is to fund our R&D activities. We have funded our operations primarily through public offerings of our common stock and private placements of equity and convertible securities. As of September 30, 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
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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.
Private Placement
In May 2025, we closed on a private placement offering with Dong-A ST, a related party, and Dong-A Socio Holdings Co., Ltd., an affiliate company of Dong-A ST, and received gross proceeds of $10.0 million, before deducting the placement agent’s fees and related offering expenses. The private placement was comprised of (i) 9,479,345 shares of our common stock at a price of $0.71 per share and (ii) 4,605,162 pre-funded warrants to purchase up to an equivalent number of shares of our common stock at a price of $0.709 per pre-funded warrant. The pre-funded warrants had an exercise price of $0.001 per pre-funded warrant. For additional information, see “Note 6. Stockholders’ equity” to the condensed consolidated financial statements included elsewhere in this Report.
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).
Nine Months Ended September 30, | ||||||
| 2025 | 2024 | ||||
Net cash used in operating activities | $ | (10,841) | $ | (19,241) | ||
Net cash used in investing activities |
| (2) | (8) | |||
Net cash provided by financing activities |
| 9,103 | 18,483 | |||
Net decrease in cash | $ | (1,740) | $ | (766) | ||
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.
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.
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.
For additional details, see the condensed consolidated statements of cash flows in the condensed consolidated financial statements included elsewhere in this Report.
Critical accounting estimates
Our 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 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
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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, 2024. Refer to our 2024 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 condensed consolidated financial statements included in this Report.
Item 3.Quantitative and Qualitative Disclosures about Market Risk
Not applicable.
Item 4.Controls and Procedures
Evaluation of disclosure controls and procedures
As required by Rules 13a-15(b) and 15d-15(b) under the 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 September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Part II - Other Information
Item 1.Legal Proceedings
From time to time, we may be involved in various claims and legal proceedings arising out of our ordinary course of business. We are not currently a party to any claims or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business and condensed consolidated financial statements. Regardless of outcome, litigation can
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have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A.Risk Factors
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 2024 Form 10-K and in Part II, Item 1A of the Q1 2025 Form 10-Q, 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 2024 Form 10-K.
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3.Defaults Upon Senior Securities
None.
Item 4.Mine Safety Disclosures
Not applicable.
Item 5.Other Information
On November 6, 2025, the Company entered into an At The Market Offering Agreement (the “Sales Agreement”) with Ladenburg Thalmann & Co. Inc., as sales agent and/or principal (“Ladenburg”), pursuant to which the Company may offer and sell, from time to time through or to Ladenburg, shares of the Company’s common stock, par value $0.001, having an aggregate offering price of up to $2,300,000 (the “Shares”).
The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-278646) filed by the Company with the Securities and Exchange Commission (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.
Pursuant to the 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. The Company is not obligated to make any sales of the Shares under the Sales Agreement. The offering of Shares pursuant to the Sales Agreement will terminate upon the termination of the Sales Agreement by Ladenburg or the Company, as permitted therein.
The Company is obligated to pay Ladenburg an aggregate sales agent commission of 3.0% of the gross sales price of the Shares sold pursuant to the Sales Agreement. The Company will also reimburse Ladenburg for certain specified expenses in connection with entering into the Sales Agreement. The Sales Agreement contains customary representations and warranties and conditions to the placements of the Shares pursuant thereto.
The foregoing description of the material terms of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed as Exhibit 1.1 to this Report and is incorporated herein by reference. The opinion of the Company’s counsel regarding the validity of the Shares that will be issued pursuant to the Sales Agreement is also filed as Exhibit 5.1 to this Report.
This Report shall not constitute an offer to sell or the solicitation of an offer to buy the Shares discussed herein, nor shall there be any offer, solicitation, or sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
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Item 6.Exhibits
Exhibit Number |
| Description of Document |
1.1* | ||
3.1 | ||
3.2 | ||
3.3 | ||
3.4 | ||
3.5 | ||
3.6 | ||
3.7 | ||
5.1* | ||
31.1* | ||
31.2* | ||
32.1** | ||
32.2** | ||
101.INS* | Inline XBRL Instance Document | |
101.SCH* | Inline XBRL Taxonomy Extension Schema Document | |
101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
104* | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
*Filed herewith
**Furnished herewith
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Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized, on November 6, 2025.
METAVIA INC. | |||
/s/ Hyung Heon Kim | |||
Hyung Heon Kim | |||
President and Chief Executive Officer | |||
/s/ Marshall H. Woodworth | |||
Marshall H. Woodworth | |||
Chief Financial Officer | |||
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