Table of Contents 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 September 30, 2025 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) Delaware 47-2389984 (State or othe ...

Exhibit 99.1 MetaVia Reports Third 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 Non-Titrated Maximum Tolerated Dose of DA- 1726 for the Treatment of Obesity; Top-Line Data Expected by Year-End 2025 $14.3 Million in Cash at End of Third Quarter is Expected to Fund the Company Into 2026 CAMBRIDGE, Mass., November 6, 2025 – MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company f ...

[Part I - Financial Information](index=3&type=section&id=Part%20I%20Financial%20Information) [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents MetaVia Inc.'s unaudited condensed consolidated financial statements for periods ended June 30, 2025, and December 31, 2024, including balance sheets, statements of operations, changes in stockholders' equity, cash flows, and explanatory notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Metric | June 30, 2025 (Unaudited) (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------------------- | :------------------------------- | | **Assets** | | | | Cash | $17,589 | $16,017 | | Total current assets | $18,315 | $16,072 | | Total assets | $18,459 | $16,260 | | **Liabilities** | | | | Total current liabilities | $8,820 | $8,271 | | Total liabilities | $8,835 | $8,329 | | **Stockholders' Equity** | | | | Total stockholders' equity | $9,624 | $7,931 | | Total liabilities and stockholders' equity | $18,459 | $16,260 | - Total assets increased by **$2.2 million** from December 31, 2024, to June 30, 2025, primarily driven by an increase in cash and prepaid expenses[16](index=16&type=chunk) - Total stockholders' equity increased by **$1.7 million**, reflecting new equity issuances[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--------------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Research and development | $2,320 | $8,074 | $4,647 | $12,978 | | General and administrative | $1,981 | $2,010 | $3,540 | $3,987 | | Total operating expenses | $4,301 | $10,084 | $8,187 | $16,965 | | Loss from operations | $(4,301) | $(10,084) | $(8,187) | $(16,965) | | Net loss | $(3,995) | $(10,053) | $(7,666) | $(16,767) | | Loss per share (basic and diluted) | $(0.26) | $(1.85) | $(0.60) | $(3.19) | - Net loss significantly decreased for both the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily due to reduced R&D expenses[18](index=18&type=chunk) - Loss per share improved from **$(1.85)** to **$(0.26)** for the three months and from **$(3.19)** to **$(0.60)** for the six months ended June 30, 2025, reflecting lower net loss and an increased weighted average share count[18](index=18&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) | Metric | As of January 1, 2025 (in thousands) | As of June 30, 2025 (in thousands) | | :-------------------------------- | :----------------------------------- | :--------------------------------- | | Common Stock (Amount) | $9 | $24 | | Additional Paid-In Capital | $143,779 | $153,123 | | Accumulated Deficit | $(135,857) | $(143,523) | | Total Equity | $7,931 | $9,624 | - Total stockholders' equity increased from **$7.9 million** at January 1, 2025, to **$9.6 million** at June 30, 2025, primarily due to the issuance of common stock and pre-funded warrants, net of issuance costs, totaling **$9.1 million**[20](index=20&type=chunk) - The accumulated deficit increased by **$7.7 million** during the six months ended June 30, 2025, reflecting the net loss incurred[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(7,886) | $(13,693) | | Net cash used in investing activities | $(2) | $(8) | | Net cash provided by financing activities | $9,460 | $19,200 | | Net increase in cash | $1,572 | $5,499 | | Cash at end of period | $17,589 | $27,934 | - Net cash used in operating activities decreased by **$5.8 million**, from **$13.7 million** in 2024 to **$7.9 million** in 2025, primarily due to a lower net loss[23](index=23&type=chunk) - Net cash provided by financing activities decreased by **$9.7 million**, from **$19.2 million** in 2024 to **$9.5 million** in 2025, reflecting lower proceeds from equity offerings[23](index=23&type=chunk) [Notes to the Condensed Consolidated Financial Statements (Unaudited)](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) - MetaVia Inc. is a clinical-stage biotechnology company focused on developing novel pharmaceuticals for cardiometabolic diseases, with primary programs DA-1241 (MASH) and DA-1726 (obesity and MASH)[25](index=25&type=chunk) - The company has an accumulated deficit of **$143.5 million** as of June 30, 2025, and expects continued net losses and negative cash flows, raising substantial doubt about its ability to continue as a going concern[28](index=28&type=chunk) - In May 2025, MetaVia closed a private placement offering with Dong-A ST and an affiliate, receiving net proceeds of **$9.1 million** from the issuance of common stock and pre-funded warrants[49](index=49&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses MetaVia's financial condition and operational results, highlighting decreased expenses, clinical progress, financing, and going concern status [Overview](index=19&type=section&id=Overview) - MetaVia Inc. is a clinical-stage biotechnology company focused on developing novel pharmaceuticals for cardiometabolic diseases, with two primary programs: DA-1241 for MASH and DA-1726 for obesity and MASH[69](index=69&type=chunk) - The company's operations primarily involve R&D activities, including preclinical and clinical trials, and capital raising, facing significant risks related to funding[71](index=71&type=chunk) [DA-1241 Program Update](index=19&type=section&id=DA-1241) - MetaVia is finalizing the Clinical Study Report for a Phase 2a clinical trial of DA-1241 in the U.S. for MASH, following positive top-line 16-week results announced in December 2024[72](index=72&type=chunk)[73](index=73&type=chunk) - DA-1241 is a novel GPR119 agonist with potential as a standalone or combination therapy for MASH and Type 2 Diabetes Mellitus, demonstrating beneficial effects on glucose, lipid profile, and liver inflammation in preclinical studies[75](index=75&type=chunk) [DA-1726 Program Update](index=21&type=section&id=DA-1726) - MetaVia is conducting a Phase 1 trial for DA-1726 in the U.S. for obesity, having announced positive top-line data from both single and multiple ascending dose parts in September 2024 and April 2025, respectively[77](index=77&type=chunk)[78](index=78&type=chunk) - Enrollment for a higher-dose (48 mg) MAD cohort began in late June 2025, with top-line data expected in Q4 2025, to assess maximum tolerated dose and potential for increased weight reduction[78](index=78&type=chunk) - DA-1726 is a novel oxyntomodulin analog agonist functioning as a GLP-1R and GCGR dual agonist, designed for once-weekly subcutaneous administration to reduce appetite and increase energy expenditure for weight loss[75](index=75&type=chunk) [Recent Developments](index=21&type=section&id=Recent%20developments) - April 2025: Announced positive results from the MAD Part 2 of the Phase 1 clinical trial of DA-1726 (8 mg to 32 mg range)[82](index=82&type=chunk) - May 2025: Presented Phase 2a clinical trial data for DA-1241 in MASH, demonstrating hepatoprotective and glucose-regulating effects[82](index=82&type=chunk) - May 2025: Closed a private placement offering, receiving **$10.0 million** in gross proceeds[82](index=82&type=chunk) - June 2025: All outstanding pre-funded warrants issued in May 2025 were exercised for **4,605,162 shares** of common stock[82](index=82&type=chunk) - July 2025: Dosed the first patient in the 48 mg, MAD cohort of the Phase 1 clinical trial of DA-1726[82](index=82&type=chunk) - August 2025: Announced a research collaboration with Syntekabio, Inc. to identify additional disease targets and optimize DA-1241's therapeutic profile[82](index=82&type=chunk) [Research and Development Expenses](index=23&type=section&id=Research%20and%20development%20expenses) | R&D Expense Category | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Direct expenses - DA-1241 | $277 | $2,663 | $568 | $5,858 | | Direct expenses - DA-1726 | $1,529 | $4,905 | $3,008 | $5,934 | | Total research and development | $2,320 | $8,074 | $4,647 | $12,978 | - Total R&D expenses decreased by **$5.8 million** (71.3%) for the three months and **$8.3 million** (64.2%) for the six months ended June 30, 2025, compared to the prior year, primarily due to decreased activities for DA-1241 and DA-1726 clinical trials[94](index=94&type=chunk)[95](index=95&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) - Direct R&D costs included **$1.3 million** (Q2 2025) and **$2.4 million** (YTD Q2 2025) in expenses under the Shared Services Agreement with Dong-A ST for investigational drug manufacturing and preclinical costs[95](index=95&type=chunk)[102](index=102&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20operations) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--------------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Total operating expenses | $4,301 | $10,084 | $8,187 | $16,965 | | Loss from operations | $(4,301) | $(10,084) | $(8,187) | $(16,965) | | Total other income | $306 | $31 | $521 | $198 | | Net loss | $(3,995) | $(10,053) | $(7,666) | $(16,767) | | Loss per share (basic and diluted) | $(0.26) | $(1.85) | $(0.60) | $(3.19) | - Total operating expenses decreased by **57.3%** for the three months and **51.7%** for the six months ended June 30, 2025, primarily due to lower R&D expenses[94](index=94&type=chunk)[101](index=101&type=chunk) - Net loss decreased by **$6.1 million** for the three months and **$9.1 million** for the six months ended June 30, 2025, compared to the prior year, driven by reduced operating expenses and a gain from the change in fair value of warrant liabilities[98](index=98&type=chunk)[107](index=107&type=chunk) [Going Concern](index=28&type=section&id=Going%20concern) - As of June 30, 2025, MetaVia had **$17.6 million** in cash and an accumulated deficit of **$143.5 million**, with ongoing net losses and negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern[108](index=108&type=chunk) - The company believes existing cash will fund operations into 2026 but plans to seek additional funding through equity offerings, debt financing, or collaborations, with no assurance of obtaining such financing on acceptable terms[109](index=109&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20capital%20resources) - MetaVia's primary use of cash is for R&D activities, funded mainly through public offerings and private placements of equity[111](index=111&type=chunk) - As of June 30, 2025, the company held **$17.6 million** in cash[111](index=111&type=chunk) - In May 2025, a private placement with Dong-A ST and an affiliate generated **$10.0 million** in gross proceeds from common stock and pre-funded warrant issuances[114](index=114&type=chunk) [Cash Flows](index=30&type=section&id=Cash%20flows) | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(7,886) | $(13,693) | | Net cash used in investing activities | $(2) | $(8) | | Net cash provided by financing activities | $9,460 | $19,200 | | Net increase in cash | $1,572 | $5,499 | - Net cash used in operating activities decreased by **$5.8 million** year-over-year, primarily due to a reduced net loss[116](index=116&type=chunk) - Net cash provided by financing activities decreased by **$9.7 million** year-over-year, mainly due to lower proceeds from equity offerings in 2025 compared to 2024[118](index=118&type=chunk) [Critical Accounting Estimates](index=30&type=section&id=Critical%20accounting%20estimates) - Key accounting estimates include clinical trial costs and accruals, classification of warrants as derivative liability or equity, and the fair value of stock-based compensation and warrants[37](index=37&type=chunk)[121](index=121&type=chunk) - There have been no material changes to critical accounting estimates and judgments since December 31, 2024[123](index=123&type=chunk) [Recent Accounting Pronouncements](index=31&type=section&id=Recent%20accounting%20pronouncements) - The company adopted ASU 2023-09 (Income Taxes) in December 2023, not expecting a significant impact on 2025 financial statements[34](index=34&type=chunk) - ASU 2024-03 (Expense Disaggregation Disclosures) was issued in November 2024, effective for annual periods beginning after December 15, 2026, and is currently being evaluated for its impact[35](index=35&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section states that there are no applicable quantitative and qualitative disclosures about market risk for MetaVia Inc. in this report - The company has no applicable quantitative and qualitative disclosures about market risk[125](index=125&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management confirmed effective disclosure controls and procedures as of June 30, 2025, with prior internal control weaknesses remediated - Disclosure controls and procedures were evaluated as effective as of June 30, 2025[126](index=126&type=chunk) - Previously identified material weaknesses regarding logical access over accounting software and lack of review over reconciliation of accrued clinical trial liabilities have been remediated through implemented controls[127](index=127&type=chunk)[128](index=128&type=chunk) - No other material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, beyond the remediation activities[132](index=132&type=chunk) [Part II - Other Information](index=25&type=section&id=Part%20II%20Other%20Information) [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) MetaVia Inc. is not currently a party to any legal claims or proceedings that management believes would have a material adverse effect on its business or financial statements - The company is not currently involved in any legal proceedings deemed to have a material adverse effect on its business or financial statements[133](index=133&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the comprehensive list of risk factors detailed in the 2024 Form 10-K and Q1 2025 Form 10-Q, noting that there have been no material changes to these risks since the 2024 Form 10-K - No material changes to the company's risk factors have occurred since the 2024 Form 10-K[134](index=134&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) MetaVia Inc. reports no unregistered sales of equity securities or use of proceeds during the period - There were no unregistered sales of equity securities or use of proceeds to report[135](index=135&type=chunk) [Item 3. Default Upon Senior Securities](index=33&type=section&id=Item%203.%20Default%20Upon%20Senior%20Securities) MetaVia Inc. reports no defaults upon senior securities during the period - There were no defaults upon senior securities to report[136](index=136&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable to MetaVia Inc. - Mine safety disclosures are not applicable to the company[137](index=137&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) During the three months ended June 30, 2025, no directors or Section 16 officers adopted or terminated any Rule 10b5-1(c) trading arrangements for Company securities - No directors or Section 16 officers adopted or terminated Rule 10b5-1(c) trading arrangements during the three months ended June 30, 2025[138](index=138&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) All Form 10-Q exhibits are listed, including corporate governance, warrant forms, private placement agreements, and required certifications - The exhibits include various corporate documents such as the Certificate of Incorporation, Bylaws, Form of Pre-Funded Warrant, Securities Purchase Agreement, Placement Agency Agreement, Registration Rights Agreement, and certifications from the Principal Executive Officer and Principal Financial Officer[140](index=140&type=chunk)[142](index=142&type=chunk) [Signatures](index=36&type=section&id=Signatures) - The report was signed on August 7, 2025, by Hyung Heon Kim, President and Chief Executive Officer, and Marshall H. Woodworth, Chief Financial Officer[144](index=144&type=chunk)[145](index=145&type=chunk)

[Executive Summary & Corporate Update](index=1&type=section&id=Executive%20Summary%20%26%20Corporate%20Update) This section provides an overview of MetaVia's strategic progress, key clinical developments, and financial updates, highlighting advancements in its cardiovascular metabolic assets and capital position [CEO Statement & Strategic Overview](index=1&type=section&id=CEO%20Statement%20%26%20Strategic%20Overview) MetaVia's CEO highlights significant clinical progress for DA-1726 and DA-1241, including extended Phase 1 trials and AI-driven collaborations, supported by a $10 million private placement extending cash runway to 2026 - DA-1726 (obesity) clinical development progresses with the initiation of the 48mg MAD Phase 1 trial, extended to 8 weeks to assess long-term efficacy and safety, while exploring the maximum tolerated dose[3](index=3&type=chunk) - DA-1726 at 32mg dose showed favorable efficacy and safety: average **4.3% weight loss** (Day 26), average **1.6-inch waist circumference reduction** (Day 33), fasting glucose reduction up to **18 mg/dL**, good cardiovascular safety, and mild, transient, infrequent GI side effects[3](index=3&type=chunk) - DA-1241 (MASH) preclinical data indicates synergistic effects with FGF21 analogues (e.g., Efruxifermin) in reducing hepatic fat, inflammation, and fibrosis[3](index=3&type=chunk)[4](index=4&type=chunk)[5](index=5&type=chunk) - DA-1241's 16-week Phase 2a results demonstrate hepatoprotective and glycemic regulatory effects via anti-inflammatory and anti-fibrotic pathways[5](index=5&type=chunk) - AI-driven collaboration with Syntekabio established to explore additional indications for DA-1241 beyond MASH using their DeepMatcher® AI platform[5](index=5&type=chunk) - Company is well-capitalized with a **$10 million private placement** in May, with cash flow projected to support operations until **2026**[3](index=3&type=chunk) [Second Quarter 2025 and Subsequent Highlights](index=3&type=section&id=Second%20Quarter%202025%20and%20Subsequent%20Highlights) This section outlines key events from Q2 2025 and beyond, including DA-1726 dosing, AI collaboration, DA-1241 data release, and a $10 million private placement with warrant exercise - August 2025: First patient in the 8-week extended 48mg MAD cohort of the DA-1726 Phase 1 clinical trial for obesity completed fifth dose, aiming to further explore maximum tolerated dose, safety, and early efficacy[6](index=6&type=chunk) - August 2025: Research collaboration announced with Syntekabio, Inc. to identify additional disease targets for DA-1241 beyond MASH and optimize its therapeutic properties[6](index=6&type=chunk) - July 2025: First patient in the 4-week 48mg MAD cohort of the DA-1726 Phase 1 clinical trial for obesity completed dosing, further exploring the maximum tolerated dose[6](index=6&type=chunk) - June 2025: All outstanding prepaid warrants issued in May 2025 were exercised, converting into **4,605,162 shares** of the company's common stock[6](index=6&type=chunk) - May 2025: Completed a private placement with affiliate Dong-A ST and its parent Dong-A Socio Holdings Co., Ltd., raising **$10 million** in gross proceeds[6](index=6&type=chunk) - May 2025: 16-week Phase 2a clinical trial data for DA-1241 in patients with suspected MASH presented at EASL Congress 2025, showing significant reduction in plasma ALT levels (average **22.8 U/L decrease**), **23.0 dB/m improvement** in CAP score, and improvements in FAST score and NIS-4[6](index=6&type=chunk) - April 2025: Additional positive topline results from the 4-week MAD Part 2 of the DA-1726 Phase 1 clinical trial for obesity announced, showing a dose-dependent trend in weight loss across 8mg to 32mg doses, with no clinically significant increases in heart rate or QTcF[6](index=6&type=chunk)[7](index=7&type=chunk) [Anticipated Clinical Milestones](index=4&type=section&id=Anticipated%20Clinical%20Milestones) This section outlines upcoming key clinical development milestones for MetaVia's lead product candidates, DA-1726 and DA-1241 [DA-1726 in Obesity](index=4&type=section&id=DA-1726%20in%20Obesity) Data from the 8-week 48mg MAD cohort of DA-1726 for obesity is expected in Q4 2025, aiming to determine the maximum tolerated dose - Data from the DA-1726 8-week 48mg MAD cohort is anticipated in **Q4 2025** to explore the maximum tolerated dose[10](index=10&type=chunk) [DA-1241 in MASH](index=4&type=section&id=DA-1241%20in%20MASH) The company is actively working to schedule a Phase 2 end-of-study meeting with the FDA to advance DA-1241's regulatory process for MASH treatment - The company is currently focused on scheduling a Phase 2 end-of-study meeting with the FDA for DA-1241[10](index=10&type=chunk) [Financial Results](index=4&type=section&id=Financial%20Results) This section details MetaVia's financial performance, including significant reductions in operating expenses and net loss, alongside an improved cash position [Second Quarter Financial and Operating Results](index=4&type=section&id=Second%20Quarter%20Financial%20and%20Operating%20Results) MetaVia achieved significant operating expense reductions in Q2 and H1 2025, primarily driven by decreased R&D, leading to a narrower net loss and increased cash balance, projected to support operations until 2026 Research and Development Expenses | Metric | Q2 2025 (Million USD) | Q2 2024 (Million USD) | Change (Million USD) | Change % | | :--- | :---: | :---: | :---: | :---: | | R&D Expenses | 2.3 | 8.1 | -5.8 | -71.6% | | Metric | H1 2025 (Million USD) | H1 2024 (Million USD) | Change (Million USD) | Change % | | :--- | :---: | :---: | :---: | :---: | | R&D Expenses | 4.6 | 13.0 | -8.3 | -63.8% | - R&D expenses significantly decreased, primarily due to a **$2.4 million** (Q2) / **$5.3 million** (H1) reduction in direct R&D expenses related to DA-1241 product development, and a **$3.4 million** (Q2) / **$2.9 million** (H1) reduction related to DA-1726 product development[9](index=9&type=chunk) General and Administrative Expenses | Metric | Q2 2025 (Million USD) | Q2 2024 (Million USD) | Change (Million USD) | Change % | | :--- | :---: | :---: | :---: | :---: | | G&A Expenses | 2.0 | 2.0 | 0.0 | 0.0% | | Metric | H1 2025 (Million USD) | H1 2024 (Million USD) | Change (Million USD) | Change % | | :--- | :---: | :---: | :---: | :---: | | G&A Expenses | 3.5 | 4.0 | -0.4 | -10.0% | - The decrease in H1 G&A expenses was primarily due to a **$0.7 million** reduction in consulting expenses and a **$0.2 million** reduction in other general and administrative expenses, partially offset by a **$0.3 million** increase in legal and professional fees and a **$0.2 million** increase in employee compensation and benefits[11](index=11&type=chunk) Total Operating Expenses | Metric | Q2 2025 (Million USD) | Q2 2024 (Million USD) | Change (Million USD) | Change % | | :--- | :---: | :---: | :---: | :---: | | Total Operating Expenses | 4.3 | 10.1 | -5.8 | -57.4% | | Metric | H1 2025 (Million USD) | H1 2024 (Million USD) | Change (Million USD) | Change % | | :--- | :---: | :---: | :---: | :---: | | Total Operating Expenses | 8.2 | 17.0 | -8.8 | -51.8% | - The decrease in total operating expenses was primarily attributable to the reduction in R&D expenses[11](index=11&type=chunk) Total Other Income | Metric | Q2 2025 (Million USD) | Q2 2024 (Million USD) | Change (Million USD) | Change % | | :--- | :---: | :---: | :---: | :---: | | Other Income | 0.3 | 0.031 | +0.3 | +867.7% | | Metric | H1 2025 (Million USD) | H1 2024 (Million USD) | Change (Million USD) | Change % | | :--- | :---: | :---: | :---: | :---: | | Other Income | 0.5 | 0.2 | +0.3 | +150.0% | - The increase in other income was primarily due to a gain from the change in fair value of warrant liability, recording a **$0.2 million** gain in Q2 2025 compared to a **$0.1 million** loss in the prior year period[11](index=11&type=chunk) Net Loss and EPS | Metric | Q2 2025 | Q2 2024 | Change | Change % | | :--- | :---: | :---: | :---: | :---: | | Net Loss (Million USD) | 4.0 | 10.1 | -6.1 | -60.4% | | Basic and Diluted Loss Per Share | 0.26 | 1.85 | -1.59 | -85.9% | | Weighted Average Common Shares (Shares) | 15,287,278 | 5,428,906 | +9,858,372 | +181.6% | | Metric | H1 2025 | H1 2024 | Change | Change % | | :--- | :---: | :---: | :---: | :---: | | Net Loss (Million USD) | 7.7 | 16.8 | -9.1 | -54.2% | | Basic and Diluted Loss Per Share | 0.60 | 3.19 | -2.59 | -81.2% | | Weighted Average Common Shares (Shares) | 12,789,616 | 5,259,939 | +7,529,677 | +143.1% | Cash Position | Metric | June 30, 2025 (Million USD) | December 31, 2024 (Million USD) | Change (Million USD) | Change % | | :--- | :---: | :---: | :---: | :---: | | Cash | 17.6 | 16.0 | +1.6 | +10.0% | - The company anticipates its cash position is sufficient to support operations until **2026**[12](index=12&type=chunk) [Consolidated Balance Sheets](index=8&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, MetaVia's consolidated balance sheet shows cash increased to $17.589 million, total assets reached $18.459 million, while accounts payable and clinical trial accruals decreased, but related party payables significantly increased, and total stockholders' equity rose to $9.624 million Consolidated Balance Sheets (Selected) | Metric (Thousand USD) | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :---: | :---: | | **Assets** | | | | Cash | 17,589 | 16,017 | | Prepaid expenses and other current assets | 726 | 55 | | **Total current assets** | **18,315** | **16,072** | | Property and equipment, net | 27 | 34 | | Right-of-use assets | 96 | 133 | | Other assets | 21 | 21 | | **Total assets** | **18,459** | **16,260** | | **Liabilities and Stockholders' Equity** | | | | Accounts payable | 2,875 | 3,879 | | Clinical trial accrued liabilities | 1,463 | 1,696 | | Accrued expenses and other current liabilities | 610 | 785 | | Warrant liability | 114 | 361 | | Related party payables | 3,675 | 1,472 | | Short-term lease liabilities | 83 | 78 | | **Total current liabilities** | **8,820** | **8,271** | | Long-term lease liabilities | 15 | 58 | | **Total liabilities** | **8,835** | **8,329** | | Common stock | 24 | 9 | | Additional paid-in capital | 153,123 | 143,779 | | Accumulated deficit | (143,523) | (135,857) | | **Total stockholders' equity** | **9,624** | **7,931** | | **Total liabilities and stockholders' equity** | **18,459** | **16,260** | [Consolidated Statements of Operations](index=9&type=section&id=Consolidated%20Statements%20of%20Operations) MetaVia significantly reduced operating and net losses in Q2 and H1 2025, driven by lower R&D and G&A expenses, alongside increased other income from warrant liability fair value changes, resulting in a narrower loss per share despite increased weighted average shares Consolidated Statements of Operations (Selected) | Metric (Thousand USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :---: | :---: | :---: | :---: | | **Operating Expenses** | | | | | | Research and development | 2,320 | 8,074 | 4,647 | 12,978 | | General and administrative | 1,981 | 2,010 | 3,540 | 3,987 | | **Total operating expenses** | **4,301** | **10,084** | **8,187** | **16,965** | | **Operating loss** | **(4,301)** | **(10,084)** | **(8,187)** | **(16,965)** | | **Other income (expense)** | | | | | | Gain (loss) from change in fair value of warrant liability | 160 | (133) | 247 | (203) | | Interest income | 146 | 164 | 274 | 401 | | **Total other income** | **306** | **31** | **521** | **198** | | **Loss before income taxes** | **(3,995)** | **(10,053)** | **(7,666)** | **(16,767)** | | **Net loss and comprehensive net loss** | **(3,995)** | **(10,053)** | **(7,666)** | **(16,767)** | | **Loss per common share, basic and diluted** | **(0.26)** | **(1.85)** | **(0.60)** | **(3.19)** | | **Weighted average common shares, basic and diluted** | **15,287,278** | **5,428,906** | **12,789,616** | **5,259,939** | [About MetaVia](index=6&type=section&id=About%20MetaVia) This section provides an overview of MetaVia Inc., a clinical-stage biotechnology company focused on cardiovascular metabolic diseases, and its lead product candidates, DA-1726 for obesity and DA-1241 for MASH [Company Overview and Product Candidates](index=6&type=section&id=Company%20Overview%20and%20Product%20Candidates) MetaVia Inc. is a clinical-stage biotech company focused on cardiovascular metabolic diseases, developing DA-1726 for obesity (GLP1R/GCGR dual agonist) and DA-1241 for MASH (GPR119 agonist), both showing promising clinical results - MetaVia Inc. is a clinical-stage biotechnology company focused on transformative therapies for cardiovascular metabolic diseases[13](index=13&type=chunk) - DA-1726 is a novel glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist for obesity, showing optimal potential in weight loss, glycemic control, and waist circumference reduction in Phase 1 trials[13](index=13&type=chunk) - DA-1241 is a novel G protein-coupled receptor 119 (GPR119) agonist for metabolic dysfunction-associated steatohepatitis (MASH), demonstrating positive effects on hepatic inflammation, lipid metabolism, weight loss, and glucose metabolism in preclinical and Phase 2a studies[13](index=13&type=chunk) [Forward Looking Statements](index=6&type=section&id=Forward%20Looking%20Statements) This section contains forward-looking statements based on current expectations and assumptions, subject to risks and uncertainties that may cause actual results to differ materially, with no obligation to update unless legally required [Disclaimer on Future Events](index=6&type=section&id=Disclaimer%20on%20Future%20Events) This section contains forward-looking statements about future events, conditions, or circumstances, based on current expectations and assumptions, subject to risks and uncertainties that may cause actual results to differ materially, with no obligation to update unless legally required - Certain statements in this press release may constitute forward-looking statements, subject to the Private Securities Litigation Reform Act of 1995[15](index=15&type=chunk) - Forward-looking statements are predictions of future events based on current expectations and assumptions, subject to risks and uncertainties that may cause actual future events to differ materially from the statements[15](index=15&type=chunk) - Risk factors include the company's ability to execute its business strategy, sufficiency of existing cash, regulatory submission timelines, ability to obtain regulatory approvals, collaboration with contract manufacturers and clinical research partners, potential negative interactions of product candidates, ability to initiate and complete clinical trials in a timely manner, ability to enroll subjects, consistency of clinical trial results with preclinical and prior trial results, costs associated with licensing agreements, and changes in laws and regulations[15](index=15&type=chunk) - The company undertakes no obligation to publicly update or revise any forward-looking statements, unless required by law[15](index=15&type=chunk)[16](index=16&type=chunk) [Contacts](index=7&type=section&id=Contacts) This section provides contact information for MetaVia's corporate and investor relations, including the Chief Financial Officer and an investor relations representative [Company and Investor Relations Contacts](index=7&type=section&id=Company%20and%20Investor%20Relations%20Contacts) This section provides contact details for MetaVia's Chief Financial Officer, Marshall H. Woodworth, and investor relations representative, Michael Miller of Rx Communications Group - MetaVia Company Contact: Marshall H. Woodworth, Chief Financial Officer, Phone: **+1-857-299-1033**, Email: **marshall.woodworth@metaviatx.com**[17](index=17&type=chunk) - Investor Relations Contact: Michael Miller of Rx Communications Group, Phone: **+1-917-633-6086**, Email: **mmiller@rxir.com**[17](index=17&type=chunk)

Part I - Financial Information [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) MetaVia Inc.'s unaudited financial statements report a $3.7 million net loss for the quarter, highlighting going concern risk from continued losses [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets | Metric | March 31, 2025 (Unaudited) (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------------------- | :------------------------------- | | Cash | $11,190 | $16,017 | | Total current assets | $11,961 | $16,072 | | Total assets | $12,127 | $16,260 | | Total current liabilities | $7,710 | $8,271 | | Total liabilities | $7,747 | $8,329 | | Total stockholders' equity | $4,380 | $7,931 | - **Cash decreased by $4,827 thousand** from December 31, 2024, to March 31, 2025[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Condensed Consolidated Statements of Operations | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | | Research and development expenses | $2,327 | $4,904 | | General and administrative expenses | $1,559 | $1,977 | | Total operating expenses | $3,886 | $6,881 | | Loss from operations | $(3,886) | $(6,881) | | Net loss | $(3,671) | $(6,714) | | Loss per share (basic and diluted) | $(0.36) | $(1.32) | | Weighted average shares outstanding | 10,264,202 | 5,089,408 | - **Net loss decreased by $3,043 thousand (45.3%)** from $6,714 thousand in Q1 2024 to $3,671 thousand in Q1 2025[17](index=17&type=chunk) - **Loss per share decreased from $(1.32) in Q1 2024 to $(0.36) in Q1 2025**, despite a significant increase in weighted average shares outstanding[17](index=17&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Condensed Consolidated Statements of Changes in Stockholders' Equity | Metric | As of January 1, 2025 (in thousands) | As of March 31, 2025 (in thousands) | | :-------------------------- | :----------------------------------- | :---------------------------------- | | Common Stock (Amount) | $9 | $9 | | Additional Paid-In Capital | $143,779 | $143,899 | | Accumulated Deficit | $(135,857) | $(139,528) | | Total Equity | $7,931 | $4,380 | - **Total stockholders' equity decreased from $7,931 thousand at January 1, 2025, to $4,380 thousand at March 31, 2025**, primarily due to the net loss of $3,671 thousand[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows | Cash Flow Activity | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Net cash used in operating activities | $(4,815) | $(6,442) | | Net cash used in investing activities | $0 | $(5) | | Net cash used in financing activities | $(12) | $0 | | **Net decrease in cash** | **$(4,827)** | **$(6,447)** | - **Net cash used in operating activities decreased by $1,627 thousand**, from $6,442 thousand in Q1 2024 to $4,815 thousand in Q1 2025[24](index=24&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) - **The company is a clinical-stage biotechnology company focused on developing novel pharmaceuticals for cardiometabolic diseases, with primary programs DA-1241 (MASH) and DA-1726 (obesity and MASH)**[26](index=26&type=chunk) - As of March 31, 2025, the company had **$11.2 million in cash** and an accumulated deficit of **$139.5 million**, indicating **substantial doubt about its ability to continue as a going concern**[29](index=29&type=chunk) - The company plans to fund operations through equity offerings, debt financing, or collaborations, but there is **no assurance of obtaining financing on acceptable terms**[30](index=30&type=chunk) Outstanding Warrants as of March 31, 2025: | Warrant Issuance | Shares of Common Stock Issuable | Exercise Price | | :--------------- | :------------------------------ | :------------- | | July 2018 | 6 | $44,820.000 | | April 2020 | 159 | $3,000.000 | | January 2021 | 10,421 | $1,447.200 | | October 2021 | 15,390 | $900.000 | | November 2022 Series B | 177,938 | $0.000 | | June 2024 Placement Agent | 127,227 | $4.913 | | June 2024 Pre-Funded | 1,430,000 | $0.001 | | June 2024 Series A | 5,089,060 | $3.930 | | June 2024 Series B | 7,633,591 | $3.930 | | **Total** | **14,483,792** | | - On May 14, 2025, the company closed a private placement transaction with Dong-A ST and its parent company, raising **$10.0 million in gross proceeds** through the sale of common stock and pre-funded warrants[67](index=67&type=chunk) - **MetaVia Inc. is a clinical-stage biotechnology company focused on cardiometabolic diseases, primarily MASH and obesity, with two main programs: DA-1241 and DA-1726**[26](index=26&type=chunk) - The company has experienced **net losses and negative cash flows from operating activities** since its inception, with an **accumulated deficit of $139.5 million** as of March 31, 2025, raising **substantial doubt about its ability to continue as a going concern**[29](index=29&type=chunk)[103](index=103&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Analysis of MetaVia's financial condition and operations, covering drug candidate progress, key metrics, and ongoing going concern risk [Research and development expenses](index=20&type=section&id=Research%20and%20development%20expenses) - **R&D expenses decreased by $2.6 million (52.5%) to $2.3 million** for the three months ended March 31, 2025, compared to $4.9 million in the prior year[96](index=96&type=chunk) Research and Development Expenses (in thousands): | Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Direct costs - DA-1241 | $291 | $3,195 | | Direct costs - DA-1726 | $1,479 | $1,029 | | Other R&D costs | $25 | $219 | | Indirect costs - Employee comp. & benefits | $509 | $406 | | Indirect costs - Consulting expenses | $23 | $55 | | **Total R&D** | **$2,327** | **$4,904** | - The decrease in R&D was primarily due to a **$2.9 million reduction in DA-1241 direct R&D expenses**, partially offset by a **$0.5 million increase in DA-1726 direct R&D expenses**[97](index=97&type=chunk) [Results of operations](index=22&type=section&id=Results%20of%20operations) Summary of Results of Operations (in thousands, except per share amounts): | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Total operating expenses | $3,886 | $6,881 | | Loss from operations | $(3,886) | $(6,881) | | Total other income | $215 | $167 | | Net loss | $(3,671) | $(6,714) | | Loss per share (basic and diluted) | $(0.36) | $(1.32) | | Weighted average shares outstanding | 10,264,202 | 5,089,408 | - **Total operating expenses decreased by $3.0 million (43.5%) to $3.9 million**, driven by lower R&D and general and administrative expenses[96](index=96&type=chunk) - **Net loss decreased to $3.7 million ($0.36 per share) in Q1 2025 from $6.7 million ($1.32 per share) in Q1 2024**[101](index=101&type=chunk) [Going concern](index=25&type=section&id=Going%20concern) - As of March 31, 2025, the company had **$11.2 million in cash** and an **accumulated deficit of $139.5 million**, with a **net loss of $3.7 million** and **$4.8 million net cash used in operating activities** for the quarter[103](index=103&type=chunk) - These conditions raise **substantial doubt about the company's ability to continue as a going concern** within one year[103](index=103&type=chunk) - Management believes existing cash will fund operations into 2026 but plans to seek additional funding through equity, debt, or collaborations, with **no assurance of success**[104](index=104&type=chunk) [Liquidity and capital resources](index=25&type=section&id=Liquidity%20and%20capital%20resources) - **Primary use of cash is R&D activities**, funded mainly through public offerings and private placements of equity and convertible securities[106](index=106&type=chunk) - **Cash balance as of March 31, 2025, was $11.2 million**[106](index=106&type=chunk) Cash Flows (in thousands): | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(4,815) | $(6,442) | | Net cash used in investing activities | $0 | $(5) | | Net cash used in financing activities | $(12) | $0 | | **Net decrease in cash** | **$(4,827)** | **$(6,447)** | - **MetaVia is a clinical-stage biotechnology company focused on cardiometabolic diseases, with DA-1241 (MASH) and DA-1726 (obesity/MASH) as primary programs**[71](index=71&type=chunk) - DA-1241: Finalizing Clinical Study Report for Phase 2a trial in MASH, with **positive top-line 16-week results announced in December 2024**. An **end-of-Phase 2 meeting with the FDA is expected in H1 2025**[74](index=74&type=chunk)[75](index=75&type=chunk)[78](index=78&type=chunk) - DA-1726: Conducting a Phase 1 trial for obesity. **Positive top-line data from single ascending dose (Part 1) announced in September 2024, and multiple ascending dose (Part 2) in April 2025**. Planning higher-dose cohorts for Q3 2025, with **data expected in Q4 2025**[79](index=79&type=chunk)[80](index=80&type=chunk) - Recent developments include **positive Phase 1 results for DA-1726**, exercise of pre-funded warrants, presentation of DA-1241 Phase 2a data, and a **$10.0 million private placement with Dong-A ST in May 2025**[84](index=84&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) No applicable quantitative and qualitative disclosures about market risk are reported for the company [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were ineffective due to material weaknesses in internal control over financial reporting; remediation is ongoing - **Disclosure controls and procedures were not effective as of March 31, 2025, due to material weaknesses in internal control over financial reporting**[117](index=117&type=chunk) - **Material weaknesses identified include logical access over accounting software and lack of review over reconciliation of accrued clinical trial liabilities**[118](index=118&type=chunk) - **Remediation efforts, including enhanced controls for logical access and review of accrued clinical trial liabilities, were implemented in Q1 2025 and are expected to be fully remediated in 2025 after sufficient testing**[121](index=121&type=chunk)[126](index=126&type=chunk) Part II - Other Information [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to materially affect its business or financial statements - **MetaVia is not currently involved in any legal proceedings deemed to have a material adverse effect on its business or financial statements**[125](index=125&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company's business, financial condition, and operating results can be significantly affected by changes in U.S. trade policy - **Changes in and uncertainty surrounding U.S. trade policy could materially impact the company's business, financial condition, and results of operations**[129](index=129&type=chunk) - Potential impacts include **increased costs of materials, production process disruptions, and supply chain delays**, which could hinder product development, clinical trials, and regulatory approval[129](index=129&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period [Item 3. Default Upon Senior Securities](index=29&type=section&id=Item%203.%20Default%20Upon%20Senior%20Securities) No defaults upon senior securities were reported for the period [Item 4. Mine Safety Disclosures](index=29&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company's operations [Item 5. Other Information](index=29&type=section&id=Item%205.%20Other%20Information) No directors or Section 16 officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - **No directors or Section 16 officers adopted or terminated Rule 10b5-1 trading arrangements during the three months ended March 31, 2025**[133](index=133&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including amendments to corporate documents and certifications - **Exhibits include amendments to the Certificate of Incorporation and Bylaws, certifications (31.1, 31.2, 32.1, 32.2), and Inline XBRL documents**[133](index=133&type=chunk)[135](index=135&type=chunk)

[Executive Summary & Corporate Update](index=1&type=section&id=Executive%20Summary%20%26%20Corporate%20Update) MetaVia reported positive Phase 1 MAD results for DA-1726 in obesity, positive Phase 2a results for DA-1241 in MASH, and secured $10 million in private placement [Q1 2025 Key Achievements](index=1&type=section&id=Q1%202025%20Key%20Achievements) MetaVia reported positive Phase 1 MAD results for DA-1726 in obesity, showing significant weight loss and best-in-class potential, completed a $10 million private placement, and announced positive 16-week Phase 2a results for DA-1241 in MASH - DA-1726 Phase 1 MAD trial for obesity achieved positive topline results, demonstrating significant weight loss and best-in-class potential[2](index=2&type=chunk)[3](index=3&type=chunk) - Successfully completed a private placement, raising **$10 million** in gross proceeds[2](index=2&type=chunk)[3](index=3&type=chunk) - As of Q1 end, the company held **$11.2 million** in cash, with an additional **$10 million** from private placement, projected to fund operations into **2026**[2](index=2&type=chunk)[9](index=9&type=chunk) - Announced positive 16-week Phase 2a clinical trial results for DA-1241 in MASH[3](index=3&type=chunk)[4](index=4&type=chunk) [DA-1726 (Obesity) Clinical Progress](index=1&type=section&id=DA-1726%20(Obesity)%20Clinical%20Progress) DA-1726 Phase 1 MAD trial showed dose-dependent weight loss, significant waist circumference reduction, improved fasting glucose without hypoglycemia, and good safety with mild GI side effects - At the **32 mg** dose, DA-1726 achieved a maximum **6.3%** weight loss and an average **4.3%** weight loss by Day 26 (p=0.0005)[3](index=3&type=chunk) - **83%** of patients reported early satiety at the **32 mg** dose[3](index=3&type=chunk) - Waist circumference decreased by an average of **1.6 inches** and a maximum of **3.9 inches** by Day 33[3](index=3&type=chunk) - Fasting blood glucose decreased by up to **-18 mg/dL** with no hypoglycemic events[3](index=3&type=chunk) - Good cardiovascular safety (no QTcF prolongation, average heart rate decrease in most cohorts), with mild, transient, and infrequent gastrointestinal side effects[3](index=3&type=chunk) [DA-1241 (MASH) Clinical Progress](index=3&type=section&id=DA-1241%20(MASH)%20Clinical%20Progress) DA-1241 Phase 2a trial for MASH patients showed significant reductions in liver injury, inflammation, and fibrosis markers, improved non-invasive liver assessments, and enhanced glycemic control with good safety - DA-1241 significantly reduced plasma ALT levels, with an average decrease of **22.8 U/L** at 16 weeks[7](index=7&type=chunk) - Controlled Attenuation Parameter (CAP) score improved by **23.0 dB/m**, indicating reduced liver fat content[7](index=7&type=chunk) - Improvements in FibroScan-AST (FAST) score and NIS-4 support benefits for liver health[7](index=7&type=chunk) - DA-1241 is the first oral GPR119 agonist to demonstrate dual liver protection and glycemic regulation with good safety[4](index=4&type=chunk) [Recent Highlights and Future Milestones](index=3&type=section&id=Recent%20Highlights%20and%20Future%20Milestones) MetaVia anticipates clinical milestones for DA-1726 and DA-1241, alongside recent corporate and financial achievements including a $10 million private placement [Anticipated Clinical Milestones](index=3&type=section&id=Anticipated%20Clinical%20Milestones) MetaVia plans additional SAD/MAD cohorts for DA-1726 in Q3 2025 with data in Q4 2025, and an FDA Phase 2 end-of-phase meeting for DA-1241 in H1 2025 - DA-1726 (Obesity): Additional SAD/MAD cohorts are expected to commence in **Q3 2025** to explore maximum tolerated dose, with data anticipated in **Q4 2025**[6](index=6&type=chunk) - DA-1241 (MASH): The company anticipates an end-of-Phase 2 meeting with the FDA in **H1 2025**[9](index=9&type=chunk) [Corporate and Financial Highlights (Q4 2024 & Subsequent)](index=3&type=section&id=Corporate%20and%20Financial%20Highlights%20(Q4%202024%20%26%20Subsequent)) Recent highlights include a $10 million private placement in May 2025, DA-1241 Phase 2a data presentation at EASL, positive DA-1726 Phase 1 results, and exercise of prepaid warrants in April 2025 - **May 2025**: Completed a private placement, raising **$10 million** in gross proceeds[7](index=7&type=chunk) - **May 2025**: Presented 16-week Phase 2a clinical trial data for DA-1241 in MASH patients as a late-breaking poster at the **2025 EASL Congress**[7](index=7&type=chunk) - **April 2025**: Reported additional positive topline results from the **4-week MAD Part 2** of the DA-1726 Phase 1 clinical trial for obesity, further demonstrating its best-in-class potential[7](index=7&type=chunk) - **April 2025**: Reported the exercise of issued and outstanding prepaid warrants for **1,430,000** shares of the company's common stock, with no prepaid warrants outstanding thereafter[7](index=7&type=chunk) [First Quarter 2025 Financial Results](index=4&type=section&id=First%20Quarter%202025%20Financial%20Results) MetaVia significantly reduced net loss in Q1 2025 to $3.7 million, driven by lower operating expenses, and expects funding to last until 2026 [Q1 2025 Financial Performance Overview](index=4&type=section&id=Q1%202025%20Financial%20Performance%20Overview) MetaVia's Q1 2025 net loss significantly decreased to $3.7 million from $6.7 million in Q1 2024, primarily due to reduced R&D and G&A expenses, with $11.2 million cash at quarter-end Net Loss | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :-------------------------------- | :--------------------- | :--------------------- | :------------- | | Net Loss | $(3,671) | $(6,714) | $(3,043) | | Loss per share (basic & diluted) | $(0.36) | $(1.32) | $(0.96) | | Weighted average shares outstanding | 10,264,202 | 5,089,408 | +5,174,794 | Total Operating Expenses | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :-------------------- | :--------------------- | :--------------------- | :------------- | | Total Operating Expenses | $3,886 | $6,881 | $(2,995) | - Cash was **$11.2 million** as of March 31, 2025, compared to **$16.0 million** as of December 31, 2024[9](index=9&type=chunk)[15](index=15&type=chunk) - The company expects its cash position, combined with proceeds from the private placement, to fund operations into **2026**[9](index=9&type=chunk) [Research and Development (R&D) Expenses](index=4&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) Q1 2025 R&D expenses decreased by $2.6 million year-over-year to $2.3 million, primarily due to reduced DA-1241 development costs, partially offset by increased DA-1726 development and personnel expenses R&D Expenses | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :-------------------- | :--------------------- | :--------------------- | :------------- | | R&D Expenses | $2,327 | $4,904 | $(2,577) | - Primary reductions: **$2.9 million** decrease in direct R&D expenses for DA-1241 product development and **$0.2 million** decrease in other direct R&D costs[9](index=9&type=chunk) - Partially offset by increases: **$0.5 million** in direct R&D expenses for DA-1726 product development and **$0.1 million** in indirect R&D expenses related to employee compensation and benefits[9](index=9&type=chunk) - Expenses related to investigational drug manufacturing, non-clinical, and preclinical costs under the shared services agreement with Dong-A (related party) were **$1.1 million** in Q1 2025, compared to **$0.2 million** in Q1 2024[9](index=9&type=chunk) [General and Administrative (G&A) Expenses](index=4&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) Q1 2025 G&A expenses decreased by $0.4 million year-over-year to $1.6 million, mainly due to reduced consulting and other G&A expenses, partially offset by increased employee compensation G&A Expenses | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :-------------------- | :--------------------- | :--------------------- | :------------- | | G&A Expenses | $1,559 | $1,977 | $(418) | - Primary reductions: **$0.4 million** decrease in consulting expenses and **$0.2 million** decrease in other G&A expenses[9](index=9&type=chunk) - Partially offset by increases: **$0.2 million** in employee compensation and benefits[9](index=9&type=chunk) [Total Operating Expenses](index=4&type=section&id=Total%20Operating%20Expenses) Total operating expenses in Q1 2025 were approximately $3.9 million, a $3.0 million decrease from Q1 2024, driven by lower R&D and G&A expenses Total Operating Expenses | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :-------------------- | :--------------------- | :--------------------- | :------------- | | Total Operating Expenses | $3,886 | $6,881 | $(2,995) | - Reduction attributed to lower research and development and general and administrative expenses[9](index=9&type=chunk) [Other Income and Net Loss](index=4&type=section&id=Other%20Income%20and%20Net%20Loss) Q1 2025 other income remained consistent at $0.2 million, with a net increase from warrant liability fair value changes offset by lower interest income; net loss significantly improved to $3.7 million Other Income | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :-------------------- | :--------------------- | :--------------------- | :------------- | | Total Other Income | $215 | $167 | $48 | - Net increase in gain from changes in fair value of warrant liability was partially offset by a decrease in interest income[9](index=9&type=chunk) Net Loss | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :-------------------- | :--------------------- | :--------------------- | :------------- | | Net Loss | $(3,671) | $(6,714) | $(3,043) | [Cash Position and Funding Outlook](index=4&type=section&id=Cash%20Position%20and%20Funding%20Outlook) MetaVia held $11.2 million in cash as of March 31, 2025, a decrease from $16.0 million, but expects funding to support operations until 2026 with the $10 million private placement - Cash balance was **$11.2 million** as of March 31, 2025[9](index=9&type=chunk)[15](index=15&type=chunk) - Cash balance was **$16.0 million** as of December 31, 2024[9](index=9&type=chunk)[15](index=15&type=chunk) - Projected funding period: Including proceeds from the private placement, operations are expected to be funded into **2026**[9](index=9&type=chunk) [Company Profile](index=5&type=section&id=Company%20Profile) MetaVia Inc. is a clinical-stage biotech company focused on cardiovascular metabolic diseases, developing DA-1726 for obesity and DA-1241 for MASH [About MetaVia Inc.](index=5&type=section&id=About%20MetaVia%20Inc.) MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiovascular metabolic diseases with its pipeline, including DA-1726 for obesity and DA-1241 for MASH - MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiovascular metabolic diseases[10](index=10&type=chunk) - The company is currently developing DA-1726 for obesity and DA-1241 for metabolic dysfunction-associated steatohepatitis (MASH)[10](index=10&type=chunk) [Product Descriptions](index=5&type=section&id=Product%20Descriptions) DA-1726 is a novel GLP1R/GCGR dual agonist for weight loss, while DA-1241 is a GPR119 agonist promoting gut peptide release with positive effects on liver inflammation, lipid metabolism, and glucose control - DA-1726 is a novel glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist, designed to achieve superior weight loss by reducing food intake and increasing energy expenditure[10](index=10&type=chunk) - DA-1241 is a novel G protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY[10](index=10&type=chunk) - In preclinical and Phase 2a clinical studies, DA-1241 has shown positive effects on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, liver inflammation, and fibrosis while improving glycemic control[10](index=10&type=chunk) [Legal and Investor Information](index=5&type=section&id=Legal%20and%20Investor%20Information) This section provides standard forward-looking statements disclaimers and contact information for MetaVia's CFO and investor relations [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section contains standard disclaimers regarding forward-looking statements, emphasizing risks and uncertainties that may cause actual future events to differ materially from expectations, with no obligation to update unless legally required - Forward-looking statements are predictions, projections, and other statements about future events based on current expectations and assumptions, and are therefore subject to risks and uncertainties[12](index=12&type=chunk) - Many factors could cause actual future events to differ materially from forward-looking statements, including MetaVia's ability to execute its business strategy, sufficiency of existing cash to fund operations, regulatory submission timelines, ability to obtain regulatory approvals, and realization of benefits from the license agreement with Dong-A ST Co. Ltd[12](index=12&type=chunk) - Unless required by law, MetaVia undertakes no obligation to publicly update or revise any forward-looking statements[12](index=12&type=chunk) [Contacts](index=6&type=section&id=Contacts) This section provides contact details for MetaVia's Chief Financial Officer and investor relations inquiries through Rx Communications Group - MetaVia Chief Financial Officer: Marshall H. Woodworth, Phone: **+1-857-299-1033**, Email: marshall.woodworth@metaviatx.com[13](index=13&type=chunk) - Rx Communications Group: Michael Miller, Phone: **+1-917-633-6086**, Email: mmiller@rxir.com[13](index=13&type=chunk) [Consolidated Financial Statements](index=7&type=section&id=Consolidated%20Financial%20Statements) This section presents MetaVia's consolidated balance sheets and statements of operations, highlighting changes in assets, liabilities, equity, and net loss for Q1 2025 [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $12.1 million from $16.3 million, primarily due to reduced cash, while total liabilities decreased to $7.7 million and total stockholders' equity decreased to $4.4 million Total Assets | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | Change | | :-------------------- | :---------------------------- | :----------------------------- | :----- | | Total Assets | $12,127 | $16,260 | $(4,133) | | Cash | $11,190 | $16,017 | $(4,827) | Total Liabilities | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | Change | | :-------------------- | :---------------------------- | :----------------------------- | :----- | | Total Liabilities | $7,747 | $8,329 | $(582) | Total Stockholders' Equity | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | Change | | :-------------------- | :---------------------------- | :----------------------------- | :----- | | Total Stockholders' Equity | $4,380 | $7,931 | $(3,551) | [Consolidated Statements of Operations](index=8&type=section&id=Consolidated%20Statements%20of%20Operations) Q1 2025 net loss significantly improved to $3.7 million from $6.7 million in Q1 2024, driven by a $3.0 million reduction in total operating expenses, with loss per share decreasing to $0.36 despite increased weighted average shares outstanding Net Loss | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :-------------------------------- | :--------------------- | :--------------------- | :------------- | | Net Loss | $(3,671) | $(6,714) | $(3,043) | Total Operating Expenses | Metric | Q1 2025 (in thousands) | Q1 2024 (in thousands) | Change (YoY) | | :-------------------- | :--------------------- | :--------------------- | :------------- | | Total Operating Expenses | $3,886 | $6,881 | $(2,995) | Loss per share (basic & diluted) | Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :-------------------------------- | :------ | :------ | :----------- | | Loss per share | $(0.36) | $(1.32) | $(0.96) | Weighted average common shares (basic & diluted) | Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :-------------------------------- | :---------- | :---------- | :----------- | | Weighted average shares | 10,264,202 | 5,089,408 | +5,174,794 |

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]