NeuroBo Pharmaceuticals(NRBO) - 2025 Q1 - Quarterly Results

Executive Summary & Corporate Update 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 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][3] - Successfully completed a private placement, raising $10 million in gross proceeds[2][3] - 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][9] - Announced positive 16-week Phase 2a clinical trial results for DA-1241 in MASH[3][4] DA-1726 (Obesity) Clinical Progress 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] - 83% of patients reported early satiety at the 32 mg dose[3] - Waist circumference decreased by an average of 1.6 inches and a maximum of 3.9 inches by Day 33[3] - Fasting blood glucose decreased by up to -18 mg/dL with no hypoglycemic events[3] - Good cardiovascular safety (no QTcF prolongation, average heart rate decrease in most cohorts), with mild, transient, and infrequent gastrointestinal side effects[3] DA-1241 (MASH) Clinical Progress 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] - Controlled Attenuation Parameter (CAP) score improved by 23.0 dB/m, indicating reduced liver fat content[7] - Improvements in FibroScan-AST (FAST) score and NIS-4 support benefits for liver health[7] - DA-1241 is the first oral GPR119 agonist to demonstrate dual liver protection and glycemic regulation with good safety[4] Recent Highlights and Future Milestones 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 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] - DA-1241 (MASH): The company anticipates an end-of-Phase 2 meeting with the FDA in H1 2025[9] Corporate and Financial Highlights (Q4 2024 & Subsequent) 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] - 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] - 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] - 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] First Quarter 2025 Financial Results 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 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][15] - The company expects its cash position, combined with proceeds from the private placement, to fund operations into 2026[9] Research and Development (R&D) Expenses 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] - 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] - 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] General and Administrative (G&A) Expenses 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] - Partially offset by increases: $0.2 million in employee compensation and benefits[9] Total Operating Expenses 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] Other Income and Net Loss 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] 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 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][15] - Cash balance was $16.0 million as of December 31, 2024[9][15] - Projected funding period: Including proceeds from the private placement, operations are expected to be funded into 2026[9] Company Profile 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. 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] - The company is currently developing DA-1726 for obesity and DA-1241 for metabolic dysfunction-associated steatohepatitis (MASH)[10] Product Descriptions 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] - 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] - 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] Legal and Investor Information This section provides standard forward-looking statements disclaimers and contact information for MetaVia's CFO and investor relations Forward-Looking Statements 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] - 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] - Unless required by law, MetaVia undertakes no obligation to publicly update or revise any forward-looking statements[12] 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] - Rx Communications Group: Michael Miller, Phone: +1-917-633-6086, Email: mmiller@rxir.com[13] Consolidated Financial Statements 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 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 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 |