OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-37809 METAVIA INC. (Exact name of Registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 (Mark One) Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 Table of Contents Not applicable (Former name, former add ...

Exhibit 99.1 MetaVia Reports Second Quarter 2025 Financial Results and Provides Corporate Update Dosed the First Patient in the 8-Week 48 mg MAD Cohort of its Phase 1 Clinical Trial to Further Explore Maximum Tolerated Dose of DA-1726 for the Treatment of Obesity; Top-Line Data Expected in the Fourth Quarter of 2025 Signed AI-Driven Collaboration with Syntekabio to Explore Additional Indications for DA-1241 Beyond MASH $17.6 Million in Cash at End of Second Quarter is Expected to Fund the Company Into 2026 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 (Mark One) Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Table of Contents (857) 702-9600 (Registrant's telephone number, including area code) Not applicable (Former name, former address and former fiscal year, if ...

Exhibit 99.1 MetaVia Reports First Quarter 2025 Financial Results and Provides Corporate Update Announced Positive Top-Line Phase 1 MAD Trial Results for DA-1726 in Obesity, Demonstrating Compelling Weight Loss and Best-in-Class Potential for Glucose Control, Waist Reduction and Tolerability Additional Cohorts Planned to Determine Maximum Tolerated Dose of DA- 1726 Successfully Completed a Private Placement Resulting in $10 Million in Gross Proceeds $11.2 Million in Cash at End of First Quarter, With the Ad ...

Financial Performance - As of December 31, 2024, the company reported a net loss of $27.6 million and an accumulated deficit of $135.9 million[186]. - The company has not generated any revenue to date and does not anticipate generating significant revenue until marketing approval for its product candidates is obtained[187]. - The company expects R&D expenses to increase due to planned clinical trials for product candidates, leading to continued significant losses from operating activities[187]. - The company believes its existing cash will fund operations into the third quarter of 2025, but additional capital may be required, which could dilute existing stockholders[189]. - The company has outstanding warrants to purchase 14,483,792 shares of common stock, which could result in dilution for existing shareholders if exercised[193]. - The company is obligated to make milestone payments and royalties under the 2022 License Agreement, which may strain financial resources if milestones are achieved[204]. - Adverse global economic conditions, including inflation and rising interest rates, could negatively impact the company's ability to raise capital and its overall business[196]. Product Development and Regulatory Approval - The company is focused on developing DA-1241 for MASH, a market with limited competition, but regulatory approval may be costly and time-consuming[201]. - DA-1241 and DA-1726 require successful completion of several clinical trials to demonstrate efficacy and safety before submitting an NDA to the FDA[206]. - The approval process for DA-1241 and DA-1726 is complex, lengthy, and uncertain, with potential delays or denials due to various factors including trial design disagreements and insufficient data[207]. - There is no guarantee that DA-1241 and DA-1726 will receive regulatory approval, even if successful in clinical trials, and they may be approved for limited indications[208]. - Clinical trials may be delayed, suspended, or terminated for various reasons, which could increase costs and slow down product development[222]. - Undesirable side effects from product candidates could lead to delays in marketing approval or result in more restrictive labels[216]. - Delays in clinical trials could jeopardize the ability to submit marketing approval applications and generate revenues from product sales[221]. Market and Competitive Landscape - The company faces substantial competition in the development and commercialization of new products, with many competitors having greater financial and technical resources[231]. - There is only one approved treatment for MASH, while various therapeutics are used off-label, indicating a competitive landscape with multiple companies developing products for MASH[232]. - The commercial success of the company's product candidates will depend on market acceptance among hospitals, physicians, patients, and healthcare payors[236]. - Coverage and adequate reimbursement from government and private payors are critical for the acceptance of any approved product candidates[240]. - The company must demonstrate compelling advantages of its products over existing treatments to achieve market success[230]. Strategic and Operational Risks - The company may seek collaboration arrangements with biopharmaceutical companies for the development or commercialization of current and potential future drug candidates, facing significant competition in establishing these collaborations[225]. - The company faces substantial liabilities from product liability lawsuits, which could disrupt business operations and divert management's attention[246]. - The company relies on collaborative partners for the development of product candidates, which subjects it to risks related to resource allocation and potential competition[250]. - Establishing sales and marketing capabilities is costly and time-consuming, potentially delaying product launches and incurring unnecessary expenses[252]. - The company is highly dependent on retaining qualified scientific, technical, and managerial personnel, with intense competition for such talent in the pharmaceutical field[310]. Intellectual Property and Legal Risks - The company relies on trade secrets, patents, copyright, and trademark laws for intellectual property protection, which may offer limited protection[288]. - The uncertainty surrounding patent positions in the pharmaceutical and biotechnology sectors can lead to litigation, affecting the commercial value of patents[290]. - The company may face challenges in enforcing its intellectual property rights globally, particularly in jurisdictions with weaker protections[294]. - Legal proceedings related to intellectual property could be expensive and time-consuming, potentially diverting resources from core business activities[303]. - The company may be subject to claims regarding the wrongful use of trade secrets from former employers of its employees, which could lead to costly litigation[305]. Compliance and Regulatory Environment - The company is subject to various healthcare laws and regulations, which could expose it to significant penalties and operational restrictions[262]. - Compliance with export and import controls, anti-corruption laws, and anti-money laundering regulations is essential, as violations could result in severe consequences for the company[265]. - Legislative changes may increase the difficulty and cost of obtaining marketing approval, affecting the company's ability to profitably sell products[259]. - Governments outside the U.S. impose strict price controls, which may adversely affect the company's revenues[261]. Financial and Operational Management - The company has identified material weaknesses in its internal control over financial reporting, particularly related to management review over clinical trial accruals[333]. - The company has regained compliance with Nasdaq's Minimum Bid Price Requirement of $1.00 per share for thirty consecutive business days, but there is no assurance of maintaining compliance[329]. - The company does not anticipate declaring or paying any cash dividends in the foreseeable future, focusing instead on retaining earnings for business development[348]. - The company is classified as a "smaller reporting company," allowing it to take advantage of reduced reporting requirements, which may affect the attractiveness of its common stock to investors[331]. - The company faces risks related to system failures, cyber security incidents, and natural disasters that could disrupt operations and increase costs[335]. Future Outlook and Growth Challenges - The company intends to market its product candidates outside of the U.S., which exposes it to various international business risks, including regulatory compliance and market entry challenges[313]. - The pharmaceutical industry is characterized by rapid technological changes, which could render the company's products obsolete or uncompetitive[315]. - The company may not develop additional proprietary technologies that are patentable, which could impact its competitive position[310]. - The company may experience decreased demand for products, reputational damage, and significant litigation costs due to product liability claims[248]. - Future acquisitions or mergers may disrupt the company’s operations and could lead to dilution of stockholder value[279].

Financial Performance - MetaVia reported a net loss of $27.6 million for the year ended December 31, 2024, or $3.56 per share, compared to a net loss of $12.5 million, or $2.46 per share, for the year ended December 31, 2023[12]. - The net loss for the year was $27.592 million in 2024, compared to a net loss of $12.470 million in 2023, indicating a 121% increase in losses[18]. - Loss per share of common stock increased to $3.56 in 2024 from $2.46 in 2023, reflecting a 44.8% increase[18]. - Loss before income taxes increased to $27.592 million in 2024 from $12.470 million in 2023, representing a 121% increase[18]. Expenses - Research and Development (R&D) expenses increased to approximately $21.6 million for the year ended December 31, 2024, from approximately $9.2 million in 2023, reflecting a $12.4 million increase primarily due to higher clinical trial expenditures[8]. - Research and development expenses increased significantly to $21.553 million in 2024 from $9.158 million in 2023, representing a 135% increase[18]. - Total operating expenses for the year ended December 31, 2024, were approximately $28.8 million, up from approximately $15.9 million in 2023, marking an increase of approximately $12.9 million[12]. - Total operating expenses rose to $28.809 million in 2024, up from $15.886 million in 2023, marking an increase of 81%[18]. - General and administrative expenses rose to $7.256 million in 2024 from $6.728 million in 2023, an increase of 7.8%[18]. Income and Assets - The company reported approximately $1.2 million in other income for the year ended December 31, 2024, down from approximately $3.4 million in 2023, primarily due to a lower gain related to the change in fair value of warrant liabilities[12]. - Total other income decreased to $1.217 million in 2024 from $3.416 million in 2023, a decline of 64%[18]. - Change in fair value of warrant liabilities decreased to $297 thousand in 2024 from $2.955 million in 2023, a decline of 90%[18]. - Interest income increased to $920 thousand in 2024 from $461 thousand in 2023, showing a growth of 99%[18]. - MetaVia's total assets decreased to $16.3 million as of December 31, 2024, from $22.8 million as of December 31, 2023[16]. Clinical Trials and Developments - DA-1241 achieved a statistically significant reduction in alanine transaminase (ALT) levels at weeks 4 and 8 in a Phase 2a clinical trial, with positive results also in secondary endpoints including hemoglobin A1C (HbA1C) levels[8]. - Top-line data from the MAD Part 2 study of DA-1726 is expected in April 2025, with plans for an early proof-of-concept study to commence in Q4 2025[8]. - The company plans to present the complete data set from the Phase 2a clinical trial of DA-1241 at a major medical meeting in 2025 and anticipates an end-of-Phase 2 meeting with the FDA in the first half of 2025[4]. Corporate Changes - MetaVia's common stock began trading on the Nasdaq under the new ticker symbol "MTVA" following a strategic realignment and name change from "NeuroBo Pharmaceuticals, Inc." in November 2024[8].

Core Viewpoint - NeuroBo Pharmaceuticals, Inc. is undergoing a corporate name change to "MetaVia Inc." and will begin trading under the new Nasdaq ticker symbol "MTVA" effective November 29, 2024, as part of a strategic realignment ahead of significant clinical milestones [1][2][3] Company Overview - NeuroBo Pharmaceuticals is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, currently developing DA-1726 for obesity treatment and DA-1241 for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [5] Financial Position - The company remains well-funded following a successful financing round in June 2024, raising up to $70 million in aggregate gross proceeds, which includes $20 million upfront and $50 million in clinical milestone-based warrants [3] Clinical Development - Data from the Phase 2a clinical trial for DA-1241, a GPR119 agonist for MASH treatment, is expected to be reported in December 2024 [4] - Top-line data from the Phase 1 clinical trial of DA-1726, a dual agonist for obesity treatment, is anticipated in the first quarter of 2025 [4] - DA-1726 is believed to have a better tolerability profile compared to currently marketed GLP-1 agonists, potentially making it a best-in-class obesity drug [4]

Company Overview - NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases [3] - The company is developing DA-1726 for obesity treatment and DA-1241 for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [3] - DA-1726 is a novel oxyntomodulin (OXM) analogue acting as a dual agonist for glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), potentially leading to superior weight loss compared to selective GLP1R agonists [3] - DA-1241 is a G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of gut peptides GLP-1, GIP, and PYY, showing positive effects on liver inflammation, lipid metabolism, weight loss, and glucose metabolism in preclinical studies [3] Investor Engagement - NeuroBo Pharmaceuticals will participate in the Life Science Virtual Investor Forum on November 14, 2024, with presentations by CEO Hyung Heon Kim and CFO Marshall H. Woodworth [1] - The company will also present at the Winter 2024 Investor Summit Virtual on November 21, 2024, with the same management team [1] - Interested parties can register for the conferences to listen to presentations or schedule one-on-one meetings [1][2]

Financial Performance - Total operating expenses for the three months ended September 30, 2024, were $6.3 million, an increase of $2.4 million, or 60.8%, compared to the same period in 2023[89]. - Net loss for the three months ended September 30, 2024, was $5.7 million, or $0.55 per share, compared to a net loss of $3.8 million, or $0.75 per share for the same period in 2023[94]. - Total operating expenses for the nine months ended September 30, 2024, were $23.2 million, an increase of $13.0 million, or 127.3%, compared to the same period in 2023[95]. - Net loss for the nine months ended September 30, 2024, was $22.4 million, or $3.24 per share, compared to a net loss of $7.2 million, or $1.41 per share for the same period in 2023[100]. - Cash balance as of September 30, 2024, was $21.7 million, with an accumulated deficit of $130.7 million[102]. - Net cash used in operating activities was $19.3 million for the nine months ended September 30, 2024, compared to $7.4 million for the same period in 2023[108]. - Net cash provided by financing activities was $18.5 million for the nine months ended September 30, 2024, compared to net cash used of $0.1 million in 2023[110]. Research and Development - Research and development expenses for the three months ended September 30, 2024, were $4.5 million, an increase of $2.2 million, or 97.1%, compared to the same period in 2023[90]. - Research and development expenses for the nine months ended September 30, 2024, were $17.5 million, an increase of $12.2 million compared to the same period in 2023[95]. - R&D expenses increased by $12.2 million, or 230.5%, to $17.5 million for the nine months ended September 30, 2024, primarily due to clinical trial activities for DA-1241 and DA-1726[96]. - DA-1241 is currently in a Phase 2a trial for the treatment of MASH, with 109 patients randomized and top-line results expected in December 2024[77]. - DA-1726 is in a Phase 1 trial for obesity, with 45 subjects randomized in the single ascending dose study, which was found to be safe and well tolerated[80]. - A joint research agreement was signed with ImmunoForge to develop a long-acting formulation of DA-1726 utilizing ELP technology[84]. - An exclusive out-license agreement was signed with MThera for the development and commercialization of NB-01 for painful diabetic neuropathy[85]. Income and Expenses - Total other income for the three months ended September 30, 2024, was $0.6 million, an increase of $0.5 million, or 709.3%, compared to the same period in 2023[92]. - Total other income decreased by $2.3 million, or 73.7%, to $0.8 million for the nine months ended September 30, 2024, primarily due to lower gains from warrant liabilities[99]. - General and administrative expenses rose by $0.8 million, or 16.3%, to $5.7 million for the nine months ended September 30, 2024, mainly due to higher employee compensation[98]. Future Outlook - The company expects to continue incurring net losses and negative cash flows from operating activities for the foreseeable future due to ongoing clinical trials[102]. - The company plans to fund operations through equity offerings, debt financings, or collaborations, but there is no assurance of obtaining financing on acceptable terms[103]. Legal and Compliance - Material weaknesses in internal control over financial reporting have been identified, and remediation efforts are ongoing[119]. - NeuroBo Pharmaceuticals is not currently involved in any claims or legal proceedings that are likely to have a material adverse effect on its business[125]. - The company acknowledges that litigation can have an adverse impact due to defense and settlement costs, as well as diversion of management resources[125]. - Management believes that current legal proceedings will not materially affect the company's financial position[125]. - The company is engaged in ordinary course business activities that may lead to various claims and legal proceedings[125]. - There is an emphasis on the potential adverse impacts of litigation, highlighting risk management considerations[125]. - The company maintains a proactive stance in monitoring legal risks associated with its operations[125]. - No specific financial figures or performance metrics were disclosed in the legal proceedings section[125]. - The company continues to prioritize its core business despite potential legal challenges[125]. - Management resources may be diverted due to litigation, which could impact operational efficiency[125].

Financial Performance - NeuroBo Pharmaceuticals reported a net loss of approximately $5.7 million for Q3 2024, or $0.55 per share, compared to a net loss of approximately $3.8 million, or $0.75 per share, in Q3 2023[13]. - The net loss for the three months ended September 30, 2024, was $5,652 thousand, compared to a net loss of $3,818 thousand for the same period in 2023, reflecting an increase in loss of approximately 48.0%[24]. - The loss per share for the three months ended September 30, 2024, was $(0.55), compared to $(0.75) for the same period in 2023[24]. Research and Development - Research and Development (R&D) expenses for Q3 2024 were approximately $4.5 million, up from approximately $2.3 million in Q3 2023, reflecting increased activities for DA-1241 and DA-1726[7]. - R&D expenses for the nine months ended September 30, 2024, were approximately $17.5 million, compared to $5.3 million for the same period in 2023, reflecting increased clinical trial expenditures[8]. - Research and development expenses for the three months ended September 30, 2024, were $4,517 thousand, up 97.2% from $2,292 thousand for the same period in 2023[24]. - Positive top-line data from the SAD Part 1 of the Phase 1 trial of DA-1726 indicated favorable safety and tolerability, with 45 participants showing no serious adverse events[5]. - Top-line results from the Phase 2a trial of DA-1241 for the treatment of MASH are expected in December 2024[6]. - The last patient visit in the MAD study Part 2 for DA-1726 is expected in Q4 2024, with top-line data anticipated in Q1 2025[6]. - The company plans to initiate Part 3 of the Phase 1 clinical trial for DA-1726 in Q3 2025, following the completion of Part 2[4]. - A joint research agreement was signed with Dong-A ST and ImmunoForge to develop a long-acting, once-monthly formulation of DA-1726[3]. Financial Position - The company had approximately $21.7 million in cash as of September 30, 2024, expected to fund operations into Q3 2025[15]. - Total current assets decreased from $22,512 thousand as of December 31, 2023, to $21,935 thousand as of September 30, 2024, a decline of approximately 2.56%[21]. - Total liabilities increased from $6,096 thousand as of December 31, 2023, to $9,193 thousand as of September 30, 2024, representing an increase of approximately 50.00%[22]. - Total stockholders' equity decreased from $16,685 thousand as of December 31, 2023, to $12,953 thousand as of September 30, 2024, a decline of approximately 22.4%[23]. Other Income and Expenses - Total other income for Q3 2024 was approximately $0.6 million, compared to $0.1 million in Q3 2023, primarily due to a gain related to the change in fair value of warrant liabilities[11]. - Total operating expenses rose to $6,259 thousand for the three months ended September 30, 2024, compared to $3,893 thousand for the same period in 2023, an increase of approximately 60.7%[24]. - The change in fair value of warrant liabilities resulted in an income of $297 thousand for the three months ended September 30, 2024, compared to an expense of $(87) thousand for the same period in 2023[24]. - Interest income increased to $310 thousand for the three months ended September 30, 2024, from $162 thousand for the same period in 2023, an increase of approximately 91.4%[24].