Moleculin Biotech | 8-K: FY2026 Q2 Revenue: USD 0
I'm LongbridgeAI, I can summarize articles.Revenue: As of FY2026 Q2, the actual value is USD 0.
EPS: As of FY2026 Q2, the actual value is USD -1.4.
EBIT: As of FY2026 Q2, the actual value is USD -7.483 M.
Financial Performance for Three Months Ended June 30, 2026 vs. 2025
- Research and Development Expenses: Moleculin Biotech, Inc. reported $5.5 million in 2026, an increase from $3.6 million in 2025, primarily due to the MIRACLE clinical trial, additional nonclinical studies, and other research costs.
- General and Administrative Expenses: These remained consistent at approximately $2.1 million in both 2026 and 2025.
- Depreciation and Amortization: Depreciation and amortization were $8 thousand in 2026, compared to $29 thousand in 2025.
- Total Operating Expenses: Total operating expenses increased to $7.6 million in 2026 from $5.7 million in 2025.
- Loss from Operations: The loss from operations was - $7.6 million in 2026, compared to - $5.7 million in 2025.
- Net Loss: The net loss significantly improved to - $7.6 million in 2026 from - $17.8 million in 2025.
Financial Performance for Six Months Ended June 30, 2026 vs. 2025
- Research and Development Expenses: Research and development expenses increased to $10.8 million in 2026 from $7.0 million in 2025.
- General and Administrative Expenses: General and administrative expenses were $4.6 million in both 2026 and 2025.
- Depreciation and Amortization: Depreciation and amortization were $16 thousand in 2026, compared to $59 thousand in 2025.
- Total Operating Expenses: Total operating expenses were $15.4 million in 2026, up from $11.7 million in 2025.
- Loss from Operations: The loss from operations was - $15.4 million in 2026, compared to - $11.7 million in 2025.
- Net Loss: The net loss improved to - $20.5 million in 2026 from - $23.7 million in 2025.
Balance Sheet Highlights (as of June 30, 2026 vs. December 31, 2025)
- Cash and Cash Equivalents: Cash and cash equivalents were $7.3 million as of June 30, 2026, down from $8.9 million as of December 31, 2025.
- Total Current Assets: Total current assets decreased to $8.7 million as of June 30, 2026, from $9.7 million as of December 31, 2025.
- Total Assets: Total assets were $21.1 million as of June 30, 2026, a decrease from $22.1 million as of December 31, 2025.
- Total Current Liabilities: Total current liabilities increased to $9.3 million as of June 30, 2026, from $6.9 million as of December 31, 2025.
- Total Liabilities: Total liabilities increased to $9.5 million as of June 30, 2026, from $7.1 million as of December 31, 2025.
- Total Stockholders’ Equity: Total stockholders’ equity decreased to $11.6 million as of June 30, 2026, from $15.0 million as of December 31, 2025.
Operational Metrics and Company-Specific Indicators
- MIRACLE Trial Efficacy: Interim data from the Phase 2⁄3 MIRACLE trial showed complete remission (CR) rates of 43% and 36% in Annamycin treatment arms (190 mg/m² and 230 mg/m² plus cytarabine, respectively), compared to 12% for the control arm. Composite complete remission (CRc) reached 50% and 57% in Annamycin cohorts versus 29% for the control arm.
- Cardiotoxicity: Moleculin Biotech, Inc. reported no detectable cardiotoxicity with Annamycin, even with cumulative exposure levels exceeding conventional anthracycline limits, with this absence continuing to be observed in the MIRACLE trial.
- Enrollment Progress: Over 80% of the planned 90 patients in Part A of the MIRACLE trial were enrolled as of the interim analysis.
- Pipeline Programs: Moleculin Biotech, Inc. continues to support development activities for WP1066 through investigator-sponsored and externally funded studies and is also developing the WP1122 portfolio.
Outlook and Guidance
Moleculin Biotech, Inc. anticipates its cash position, including $9.3 million raised after quarter-end, will fund operations into the first quarter of 2027. The company expects to complete enrollment in Part A of the MIRACLE trial by September 2026, with data unblinding for 90 subjects projected between December 2026 and February 2027. Part B of the MIRACLE trial is slated to commence in the first half of 2027, with the goal of initiating a rolling New Drug Application (NDA) submission for accelerated approval in 2028 and completing it in 2029.
