Financial Performance - The net loss for the three months ended September 2024 was $10,592,000, compared to a net loss of $5,609,000 for the same period in 2023, indicating an increase in losses of 88.5%[20] - The net loss per common share for the three months ended September 2024 was $(2.85), slightly higher than $(2.82) for the same period in 2023[20] - Total operating expenses for the three months ended September 2024 were $7,135,000, compared to $5,947,000 for the same period in 2023, reflecting a 19.9% increase[20] - Interest income for the three months ended September 2024 was $102,000, a decrease from $324,000 for the same period in 2023, representing a decline of 68.5%[20] - Other income, net for the three months ended September 2024 was $9,000, down from $13,000 for the same period in 2023, a decrease of 30.8%[20] - The total loss from operations for the nine months ended September 2024 was $19,998,000, compared to $20,712,000 for the same period in 2023, showing a slight improvement of 3.4%[20] Research and Development - Research and development (R&D) expense increased to $4.9 million for Q3 2024, up from $3.3 million in Q3 2023, primarily due to clinical trial costs[9] - Research and development expenses for the three months ended September 2024 were $4,932,000, an increase from $3,280,000 for the same period in 2023, representing a 50.3% increase[20] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for R/R AML treatment[4] - The company plans to present final data from the Phase 2 study of Annamycin for soft tissue sarcoma lung metastases in 2025[8] Clinical Trials - The company is on track to start dosing in the pivotal Phase 3 MIRACLE trial in Q1 2025, aimed at treating relapsed or refractory acute myeloid leukemia (R/R AML) with Annamycin and cytarabine[1] - The median durability of complete response composite (CRc) in the MB-106 trial has exceeded 8 months[2] - The MIRACLE trial will initially randomize approximately 75 to 90 subjects to receive high dose cytarabine combined with either placebo or Annamycin[6] - Expected milestones for the MIRACLE trial include first subject treated in Q1 2025 and interim efficacy data unblinded in 2H 2026[7] Financial Position - As of September 30, 2024, the company had cash and cash equivalents of $9.4 million, expected to fund operations into Q1 2025[10] - The company closed a financing of $5.5 million, with potential additional gross proceeds of up to $11.0 million upon the exercise of milestone-linked warrants[3] Administrative Expenses - General and administrative expense decreased to $2.2 million in Q3 2024 from $2.6 million in Q3 2023, reflecting a reduction in regulatory and legal fees[10]
Moleculin(MBRX) - 2024 Q3 - Quarterly Results