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Investor Relations14 Oct 2025
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Moleculin Biotech (MBRX) investor relations material
Moleculin Biotech Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2025 earnings summary13 Aug, 2025
Executive summary
Conducting pivotal MIRACLE Phase 3 trial for Annamycin in relapsed/refractory AML, with interim unblinding expected by end of 2025 and further unblinding in H1 2026.
Expanded MIRACLE trial to over 35 global sites, including the EU and Georgia, with 8 subjects treated as of July 25, 2025.
Achieved positive topline results in Phase 1B/2 STS lung metastases trial, showing median OS of 13.5 months in heavily pretreated patients.
Annamycin has shown no evidence of cardiotoxicity in 84 subjects across five clinical trials.
Advanced patent protection for Annamycin in the US and EU, with exclusivity to 2040.
Financial highlights
Net loss of $7.6 million for Q2 2025, compared to $4.3 million in Q2 2024; net loss of $14.1 million for the six months ended June 30, 2025.
Research and development expenses decreased to $3.6 million in Q2 2025 from $4.1 million in Q2 2024, mainly due to reduced clinical trial activity.
General and administrative expenses were $2.1 million in Q2 2025, flat year-over-year.
Cash and cash equivalents were $7.6 million as of June 30, 2025, up from $4.3 million at December 31, 2024, due to financing activities.
Recorded a $9.6 million gain from change in fair value of warrant liability in Q2 2025.
Outlook and guidance
Cash on hand is expected to fund operations into Q4 2025; an additional $10 million in funding is needed to support operations and the MIRACLE trial into Q1 2026.
Interim unblinding of MIRACLE trial data targeted for H2 2025, with further unblinding in H1 2026.
Plan to initiate pediatric AML trial in 2027 and submit NDA for Annamycin in 2028.
Actively seeking additional funding through equity, debt, partnerships, or delaying planned cash outlays.
When will the MIRACLE Part A data readout be?
Discuss the EU's requirement for Phase 3 initiation.
Assess the sufficiency of current cash reserves.
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Next Moleculin Biotech earnings date
Q3 202512 Nov, 2025
Next Moleculin Biotech earnings date
Q3 202512 Nov, 2025
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Frequently asked questions
Moleculin Biotech, Inc. (MBRX) is a clinical-stage pharmaceutical company aiming to develop treatments addressing some of the most challenging diseases in the world, including highly resistant cancers and viruses. The company's lead drug, Annamycin, is a next-generation anthracycline designed to overcome multidrug resistance with minimal cardiotoxicity, currently under development for relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. Additionally, Moleculin is working on WP1066, an Immune/Transcription Modulator targeting brain tumors, pancreatic cancer, and other malignancies, alongside WP1220 for cutaneous T-cell lymphoma and WP1122, aimed at treating COVID-19 and glioblastoma multiforme, among other conditions. The company is headquartered in Houston, Texas, and its shares are listed on the Nasdaq.
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