NeuroBo Pharmaceuticals(NRBO) - 2025 Q1 - Quarterly Report

Part I - Financial Information Item 1. Financial Statements (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 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] Condensed Consolidated Statements of Operations 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] - 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] Condensed Consolidated Statements of Changes in Stockholders' Equity 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] Condensed Consolidated Statements of Cash Flows 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] Notes to the Condensed Consolidated Financial Statements - 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] - 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] - 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] 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] - 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] - 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][103] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Analysis of MetaVia's financial condition and operations, covering drug candidate progress, key metrics, and ongoing going concern risk Research and development expenses - 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] 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] Results of operations 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] - 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] Going concern - 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] - These conditions raise substantial doubt about the company's ability to continue as a going concern within one year[103] - 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] Liquidity and capital resources - Primary use of cash is R&D activities, funded mainly through public offerings and private placements of equity and convertible securities[106] - Cash balance as of March 31, 2025, was $11.2 million[106] 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] - 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][75][78] - 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][80] - 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] Item 3. Quantitative and Qualitative Disclosures about Market Risk No applicable quantitative and qualitative disclosures about market risk are reported for the company Item 4. Controls and Procedures 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] - Material weaknesses identified include logical access over accounting software and lack of review over reconciliation of accrued clinical trial liabilities[118] - 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][126] Part II - Other Information Item 1. Legal Proceedings 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] Item 1A. Risk Factors 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] - 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] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities or use of proceeds were reported for the period Item 3. Default Upon Senior Securities No defaults upon senior securities were reported for the period Item 4. Mine Safety Disclosures Mine safety disclosures are not applicable to the company's operations Item 5. Other Information 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] Item 6. Exhibits 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][135]