Moleculin Biotech Anticipates Unblinding of MIRACLE Trial Data
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 13 2026
0mins
Moleculin Biotech announced it is approaching the first unblinding of data from its pivotal Phase 2B/3 "MIRACLE" trial evaluating Annamycin in combination with cytarabine for the treatment of subjects with relapsed or refractory acute myeloid leukemia. "The data coming from MIRACLE is encouraging," said Walter Klemp, chairman and CEO of Moleculin. "Against this backdrop, the data emerging from MIRACLE highlight what could be a substantial advancement, suggesting that we may finally be moving beyond the limitations that have defined standard-of-care outcomes". The company continues to expect this unblinding to occur prior to June 30. Preliminary blinded efficacy data for the first 45 subjects continues to approximate a composite complete remission rate exceeding 40% and a complete remission rate of approximately 30%.
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Current: 2.740
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Current: 2.740
Low
20.00
Averages
24.33
High
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About MBRX
Moleculin Biotech, Inc. is a Phase III clinical-stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing tumors and viruses. The Company is conducting a pivotal Phase III trial evaluating Annamycin, a non-cardiotoxic anthracycline, in combination with Cytarabine for the treatment of subjects with relapsed/refractory acute myeloid leukemia (AML). It has three core technologies and six drug candidates, three of which have shown human activity in clinical trials. Its core technologies consist of Annamycin, WP1066 Portfolio, and WP1122 Portfolio. Annamycin is designed to avoid multidrug resistance mechanisms and cardiotoxicity. Its WP1066, is an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other transcription factors, and its portfolio includes WP1193, and WP1220. Its WP1122 contains compounds including WP1096, and WP1097, which is designed to exploit the potential uses of inhibitors of glycolysis such as 2-deoxy-D-glucose (2-DG).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Moleculin Biotech Advances Cardiac Safety Profile in Annamycin Trials
- Cardiac Safety Data: At the 2026 ASCO Annual Meeting, Moleculin Biotech presented data showing that Annamycin, administered at a median cumulative dose of 660 mg/m² to 90 patients with acute myeloid leukemia, demonstrated no detectable cardiotoxicity, indicating a potential best-in-class safety profile.
- Clinical Trial Support: The independent review conducted by Cleveland Clinic cardiology specialists further validated Annamycin's safety at high doses, suggesting a shift in traditional treatment limitations and enhancing its application prospects in oncology.
- Efficacy Data Highlights: In a Phase 1b/2 study evaluating Annamycin in combination with cytarabine, the drug exhibited a 50% complete remission rate and a 60% composite remission rate, underscoring its effectiveness in treating relapsed or refractory acute myeloid leukemia.
- Future Research Directions: Moleculin's ongoing pivotal Phase 2b/3 MIRACLE trial will further assess the combination of Annamycin and cytarabine, with unblinding expected in June 2026; positive results could establish a strong foundation for market introduction.
See More
Moleculin Biotech Presents Annamycin Cardiac Safety Data at ASCO Annual Meeting
- Cardiac Safety Data Presentation: Moleculin Biotech announced that pooled cardiac safety data for its lead drug candidate Annamycin will be presented at the 2026 ASCO Annual Meeting, highlighting its potential advantages in patients with acute myeloid leukemia and soft tissue sarcoma.
- Clinical Trial Results: An independent cardiac safety review of 90 patients treated with L-Annamycin revealed a median cumulative dose of 660 mg/m2, with no significant change in left ventricular ejection fraction, indicating a superior cardiac safety profile compared to traditional chemotherapy agents.
- Efficacy Support: Annamycin demonstrated a 50% complete remission rate and a median overall survival of 12.39 months in previous Phase 1b/2 studies, further supporting its potential as an effective chemotherapy option, particularly with its advantages in avoiding cardiotoxicity.
- Future Development Prospects: The acceptance of these findings underscores Annamycin's safety profile, enhancing its application prospects in the MIRACLE trial, which may provide new treatment options for AML patients and drive the company's strategic growth in oncology.
See More
Moleculin Biotech Reports Q1 Earnings Miss
- Earnings Miss: Moleculin Biotech reported a Q1 GAAP EPS of -$3.54, missing expectations by $2.08, indicating significant challenges in profitability that could impact investor confidence.
- Cash Position: As of March 31, 2026, the company had approximately $10.3 million in cash and cash equivalents, with management believing that current resources and recent financing will support operations into Q3 2026, reflecting a degree of financial stability.
- Financing Progress: Moleculin Biotech secured $8.3 million from warrant exercises and issued new five-year warrants, which not only bolstered liquidity but also provided funding for future R&D and operations.
- Market Reaction: Despite the poor financial performance, Moleculin Biotech has opportunities to improve its financial situation in the coming months through financing and cash management measures, warranting close attention from investors regarding future developments.
See More
Moleculin Biotech Reports Early Results from MIRACLE Trial Indicating 40% Remission Rate
- Clinical Trial Progress: Moleculin has enrolled 45 patients in the MIRACLE trial, with preliminary results indicating a 40% composite complete remission rate, suggesting Annamycin's potential to significantly improve outcomes for patients with difficult-to-treat acute myeloid leukemia (AML).
- Financing Enhances Operational Capacity: The company completed financing transactions in Q1 2026, generating approximately $8.3 million, which strengthens its near-term operational runway and is expected to support planned operations into Q3 2026.
- Global Intellectual Property Strategy: Moleculin has bolstered its global intellectual property strategy for Annamycin, now covering four continents, aiming to provide legal protection for its products in international markets and enhance its competitive position.
- Future Milestones: The first data unblinding for the MIRACLE trial is expected in Q2 2026, with plans to recruit 90 subjects thereafter, marking a critical advancement in the company's efforts in AML treatment and potentially paving the way for future drug applications.
See More
Moleculin Biotech Reveals Cardiac Safety Data for Annamycin
- Cardiac Safety Analysis: Analysis of 90 patients across five clinical trials shows that Annamycin does not induce clinically significant cardiotoxicity at high cumulative doses, indicating its potential in treating relapsed/refractory acute myeloid leukemia (R/R AML).
- Stable Left Ventricular Function: Among 78 verified patients, pre- and post-treatment ejection fraction assessments revealed no patients met criteria for clinically significant left ventricular dysfunction, with mean ejection fraction remaining stable, underscoring Annamycin's safety profile.
- Overcoming Treatment Barriers: The cardiac safety data reinforces Annamycin's clinical rationale as a differentiated anthracycline capable of overcoming the cardiac toxicity limitations of traditional agents in R/R AML, thus providing new treatment options for heavily pretreated patients.
- Future Clinical Positioning: Moleculin Biotech believes that the results published at EHA may support broader clinical positioning opportunities for Annamycin in AML and other oncology indications, particularly where cardiotoxicity concerns limit the use of anthracyclines.
See More
Moleculin Biotech's Drug Data Accepted for ASCO Presentation
- ASCO Presentation: Moleculin Biotech announced that an abstract on its lead drug candidate, annamycin, has been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for May 30, 2026, which further validates the drug's cardiac safety at high cumulative doses.
- Cardiac Safety Analysis: The abstract, titled 'Cardiac safety of L-annamycin at high cumulative anthracycline exposure,' emphasizes the potential advantages of annamycin in cancer treatment, particularly for patients at high risk of cardiotoxicity, through a pooled analysis of cardiac safety data.
- Clinical Trial Progress: Moleculin is conducting the MIRACLE trial, evaluating the combination of annamycin and the cytotoxic drug cytarabine for relapsed or refractory acute myeloid leukemia (AML), showcasing the company's ongoing innovation in cancer treatment options.
- Market Outlook: Annamycin is viewed as a next-generation anthracycline with favorable tolerability and efficacy, expected to fill gaps in current treatment regimens and enhance the company's competitiveness in the oncology drug market.
See More
Moleculin Biotech Advances Cardiac Safety Profile in Annamycin Trials
- Cardiac Safety Data: At the 2026 ASCO Annual Meeting, Moleculin Biotech presented data showing that Annamycin, administered at a median cumulative dose of 660 mg/m² to 90 patients with acute myeloid leukemia, demonstrated no detectable cardiotoxicity, indicating a potential best-in-class safety profile.
- Clinical Trial Support: The independent review conducted by Cleveland Clinic cardiology specialists further validated Annamycin's safety at high doses, suggesting a shift in traditional treatment limitations and enhancing its application prospects in oncology.
- Efficacy Data Highlights: In a Phase 1b/2 study evaluating Annamycin in combination with cytarabine, the drug exhibited a 50% complete remission rate and a 60% composite remission rate, underscoring its effectiveness in treating relapsed or refractory acute myeloid leukemia.
- Future Research Directions: Moleculin's ongoing pivotal Phase 2b/3 MIRACLE trial will further assess the combination of Annamycin and cytarabine, with unblinding expected in June 2026; positive results could establish a strong foundation for market introduction.
See More
Moleculin Biotech Presents Annamycin Cardiac Safety Data at ASCO Annual Meeting
- Cardiac Safety Data Presentation: Moleculin Biotech announced that pooled cardiac safety data for its lead drug candidate Annamycin will be presented at the 2026 ASCO Annual Meeting, highlighting its potential advantages in patients with acute myeloid leukemia and soft tissue sarcoma.
- Clinical Trial Results: An independent cardiac safety review of 90 patients treated with L-Annamycin revealed a median cumulative dose of 660 mg/m2, with no significant change in left ventricular ejection fraction, indicating a superior cardiac safety profile compared to traditional chemotherapy agents.
- Efficacy Support: Annamycin demonstrated a 50% complete remission rate and a median overall survival of 12.39 months in previous Phase 1b/2 studies, further supporting its potential as an effective chemotherapy option, particularly with its advantages in avoiding cardiotoxicity.
- Future Development Prospects: The acceptance of these findings underscores Annamycin's safety profile, enhancing its application prospects in the MIRACLE trial, which may provide new treatment options for AML patients and drive the company's strategic growth in oncology.
See More
Moleculin Biotech Reports Q1 Earnings Miss
- Earnings Miss: Moleculin Biotech reported a Q1 GAAP EPS of -$3.54, missing expectations by $2.08, indicating significant challenges in profitability that could impact investor confidence.
- Cash Position: As of March 31, 2026, the company had approximately $10.3 million in cash and cash equivalents, with management believing that current resources and recent financing will support operations into Q3 2026, reflecting a degree of financial stability.
- Financing Progress: Moleculin Biotech secured $8.3 million from warrant exercises and issued new five-year warrants, which not only bolstered liquidity but also provided funding for future R&D and operations.
- Market Reaction: Despite the poor financial performance, Moleculin Biotech has opportunities to improve its financial situation in the coming months through financing and cash management measures, warranting close attention from investors regarding future developments.
See More
Moleculin Biotech Reports Early Results from MIRACLE Trial Indicating 40% Remission Rate
- Clinical Trial Progress: Moleculin has enrolled 45 patients in the MIRACLE trial, with preliminary results indicating a 40% composite complete remission rate, suggesting Annamycin's potential to significantly improve outcomes for patients with difficult-to-treat acute myeloid leukemia (AML).
- Financing Enhances Operational Capacity: The company completed financing transactions in Q1 2026, generating approximately $8.3 million, which strengthens its near-term operational runway and is expected to support planned operations into Q3 2026.
- Global Intellectual Property Strategy: Moleculin has bolstered its global intellectual property strategy for Annamycin, now covering four continents, aiming to provide legal protection for its products in international markets and enhance its competitive position.
- Future Milestones: The first data unblinding for the MIRACLE trial is expected in Q2 2026, with plans to recruit 90 subjects thereafter, marking a critical advancement in the company's efforts in AML treatment and potentially paving the way for future drug applications.
See More
Moleculin Biotech Reveals Cardiac Safety Data for Annamycin
- Cardiac Safety Analysis: Analysis of 90 patients across five clinical trials shows that Annamycin does not induce clinically significant cardiotoxicity at high cumulative doses, indicating its potential in treating relapsed/refractory acute myeloid leukemia (R/R AML).
- Stable Left Ventricular Function: Among 78 verified patients, pre- and post-treatment ejection fraction assessments revealed no patients met criteria for clinically significant left ventricular dysfunction, with mean ejection fraction remaining stable, underscoring Annamycin's safety profile.
- Overcoming Treatment Barriers: The cardiac safety data reinforces Annamycin's clinical rationale as a differentiated anthracycline capable of overcoming the cardiac toxicity limitations of traditional agents in R/R AML, thus providing new treatment options for heavily pretreated patients.
- Future Clinical Positioning: Moleculin Biotech believes that the results published at EHA may support broader clinical positioning opportunities for Annamycin in AML and other oncology indications, particularly where cardiotoxicity concerns limit the use of anthracyclines.
See More
Moleculin Biotech's Drug Data Accepted for ASCO Presentation
- ASCO Presentation: Moleculin Biotech announced that an abstract on its lead drug candidate, annamycin, has been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for May 30, 2026, which further validates the drug's cardiac safety at high cumulative doses.
- Cardiac Safety Analysis: The abstract, titled 'Cardiac safety of L-annamycin at high cumulative anthracycline exposure,' emphasizes the potential advantages of annamycin in cancer treatment, particularly for patients at high risk of cardiotoxicity, through a pooled analysis of cardiac safety data.
- Clinical Trial Progress: Moleculin is conducting the MIRACLE trial, evaluating the combination of annamycin and the cytotoxic drug cytarabine for relapsed or refractory acute myeloid leukemia (AML), showcasing the company's ongoing innovation in cancer treatment options.
- Market Outlook: Annamycin is viewed as a next-generation anthracycline with favorable tolerability and efficacy, expected to fill gaps in current treatment regimens and enhance the company's competitiveness in the oncology drug market.
See More
