NeuroBo Pharmaceuticals(NRBO) - 2025 Q2 - Quarterly Results

Executive Summary & Corporate Update 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 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] - 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] - DA-1241 (MASH) preclinical data indicates synergistic effects with FGF21 analogues (e.g., Efruxifermin) in reducing hepatic fat, inflammation, and fibrosis[3][4][5] - DA-1241's 16-week Phase 2a results demonstrate hepatoprotective and glycemic regulatory effects via anti-inflammatory and anti-fibrotic pathways[5] - AI-driven collaboration with Syntekabio established to explore additional indications for DA-1241 beyond MASH using their DeepMatcher® AI platform[5] - Company is well-capitalized with a $10 million private placement in May, with cash flow projected to support operations until 2026[3] Second Quarter 2025 and Subsequent Highlights 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] - August 2025: Research collaboration announced with Syntekabio, Inc. to identify additional disease targets for DA-1241 beyond MASH and optimize its therapeutic properties[6] - 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] - 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] - 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] - 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] - 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][7] Anticipated Clinical Milestones This section outlines upcoming key clinical development milestones for MetaVia's lead product candidates, DA-1726 and DA-1241 DA-1726 in Obesity 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] DA-1241 in MASH 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] Financial Results 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 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] 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] 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] 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] 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] Consolidated Balance Sheets 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 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 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 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] - 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] - 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] Forward Looking Statements 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 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] - 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] - 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] - The company undertakes no obligation to publicly update or revise any forward-looking statements, unless required by law[15][16] 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 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] - Investor Relations Contact: Michael Miller of Rx Communications Group, Phone: +1-917-633-6086, Email: mmiller@rxir.com[17]