NeuroBo Pharmaceuticals(NRBO) - 2025 Q2 - Quarterly Report

Part I - Financial Information Item 1. Financial Statements (Unaudited) 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 | 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] - Total stockholders' equity increased by $1.7 million, reflecting new equity issuances[16] Condensed Consolidated Statements of Operations | 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] - 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] Condensed Consolidated Statements of Changes in Stockholders' Equity | 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] - The accumulated deficit increased by $7.7 million during the six months ended June 30, 2025, reflecting the net loss incurred[20] Condensed Consolidated Statements of Cash Flows | 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] - 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] Notes to the Condensed Consolidated Financial Statements (Unaudited) - 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] - 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] - 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] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses MetaVia's financial condition and operational results, highlighting decreased expenses, clinical progress, financing, and going concern status 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] - The company's operations primarily involve R&D activities, including preclinical and clinical trials, and capital raising, facing significant risks related to funding[71] DA-1241 Program Update - 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][73] - 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] DA-1726 Program Update - 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][78] - 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] - 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] Recent Developments - 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] - May 2025: Presented Phase 2a clinical trial data for DA-1241 in MASH, demonstrating hepatoprotective and glucose-regulating effects[82] - May 2025: Closed a private placement offering, receiving $10.0 million in gross proceeds[82] - June 2025: All outstanding pre-funded warrants issued in May 2025 were exercised for 4,605,162 shares of common stock[82] - July 2025: Dosed the first patient in the 48 mg, MAD cohort of the Phase 1 clinical trial of DA-1726[82] - August 2025: Announced a research collaboration with Syntekabio, Inc. to identify additional disease targets and optimize DA-1241's therapeutic profile[82] Research and Development Expenses | 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][95][101][102] - 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][102] Results of Operations | 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][101] - 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][107] Going Concern - 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] - 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] Liquidity and Capital Resources - MetaVia's primary use of cash is for R&D activities, funded mainly through public offerings and private placements of equity[111] - As of June 30, 2025, the company held $17.6 million in cash[111] - 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] Cash Flows | 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] - 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] Critical Accounting Estimates - 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][121] - There have been no material changes to critical accounting estimates and judgments since December 31, 2024[123] Recent Accounting Pronouncements - The company adopted ASU 2023-09 (Income Taxes) in December 2023, not expecting a significant impact on 2025 financial statements[34] - 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] Item 3. Quantitative and Qualitative Disclosures about Market Risk 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] Item 4. Controls and Procedures 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] - 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][128] - No other material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, beyond the remediation activities[132] Part II - Other Information Item 1. Legal Proceedings 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] Item 1A. Risk Factors 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] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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] Item 3. Default Upon Senior Securities MetaVia Inc. reports no defaults upon senior securities during the period - There were no defaults upon senior securities to report[136] Item 4. Mine Safety Disclosures This section states that mine safety disclosures are not applicable to MetaVia Inc. - Mine safety disclosures are not applicable to the company[137] Item 5. Other Information 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] Item 6. Exhibits 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][142] 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][145]