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Moleculin Biotech (MBRX) investor relations material
Moleculin Biotech Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary13 Nov, 2025
Executive summary
Conducting a pivotal Phase 3 MIRACLE trial for Annamycin in combination with Cytarabine for relapsed/refractory AML, with interim unblinding expected after 45 subjects and final unblinding after 90 subjects; recruitment ongoing across multiple countries.
Completed Phase 1B/2 MB-106 trial for AnnAraC in AML, showing promising complete remission rates and median overall survival, with final clinical study report expected in Q1 2026.
Expanded Annamycin research into pancreatic and liver cancers, with new investigator-initiated studies and promising preclinical data presented at major conferences.
WP1066 portfolio advancing with ongoing investigator-initiated trials in glioblastoma and preclinical work on IV formulations.
Secured new patents for Annamycin in the US, EU, Canada, and Australia, and received WHO approval for the nonproprietary name “naxtarubicin.”
Financial highlights
Net loss for Q3 2025 was $25.4 million, compared to $7.0 million in Q3 2024; net loss for the nine months ended September 30, 2025 was $49.1 million, up from $19.5 million year-over-year.
Research and development expenses decreased to $3.7 million in Q3 2025 from $4.9 million in Q3 2024, mainly due to lower drug production costs.
General and administrative expenses were $2.1 million in Q3 2025, slightly down from $2.2 million in Q3 2024.
Cash and cash equivalents were $6.7 million as of September 30, 2025, with net cash used in operating activities of $17.4 million for the nine months ended September 30, 2025.
Raised $19.8 million in financing during the nine months ended September 30, 2025, primarily through warrant exercises and public offerings.
Outlook and guidance
Cash on hand is expected to fund operations into Q1 2026; additional $7 million in funding needed to support MIRACLE trial and operations into Q2 2026.
Plans to seek further funding through equity, debt, partnerships, or delaying planned cash outlays.
Ongoing efforts to regain and maintain compliance with Nasdaq listing requirements.
How will warrant terms impact Nasdaq compliance?
Annamycin's cardiotoxicity data: market disruption?
What specific cash outlay delays are planned?
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Next Moleculin Biotech earnings date
Q4 202523 Mar, 2026
Next Moleculin Biotech earnings date
Q4 202523 Mar, 2026
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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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