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• Cash Balance: Approximately $13 million as of the end of the year, including $9 million raised in February 2025.

• Operating Expenses: Reduced by about $3 million in 2024 compared to 2023.

• Market Cap: $16.2 million with 14 million shares outstanding.

• Phase 2 Clinical Trial Results: 50% complete remission rate in second-line AML patients treated with Annamycin plus high-dose Cytarabine.

• Overall Survival: 11 months for second-line therapy patients in the Phase 2 trial.

• Progression-Free Survival: Median of 9 months in the Phase 2 trial.

• Phase 3 MIRACLE Trial: Designed to compare Annamycin plus high-dose Cytarabine against placebo plus high-dose Cytarabine.

• Interim Data Unblinding: Planned after 45 and between 75-90 subjects in the Phase 3 trial.

• Shares Trading Volume: Trailing one-year trading volume of 1.4 million shares per day.

• Warning! GuruFocus has detected 1 Warning Sign with MBRX.

Release Date: March 24, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Moleculin Biotech Inc (NASDAQ:MBRX) has initiated the MIRACLE Phase 3 pivotal trial for Annamycin, targeting relapsed and refractory AML patients, with 25 sites selected globally.

• The company has regulatory and ethics approval in its first European country and expects more approvals in the second quarter.

• Annamycin has shown promising Phase 2 data with a 50% complete remission rate in second-line AML patients, outperforming existing therapies.

• The MIRACLE trial includes multiple unblindings of data, providing stakeholders with visibility into the trial's progress.

• Moleculin Biotech Inc (NASDAQ:MBRX) has reduced operating expenses by $3 million in 2024 compared to 2023, demonstrating financial discipline.

Negative Points

• The US is expected to be one of the last countries to begin enrolling in the MIRACLE trial due to longer approval processes.

• The company faces a significant financial challenge, with the Phase 3 trial potentially costing upwards of $60 million to $70 million.

• Moleculin Biotech Inc (NASDAQ:MBRX) has a limited cash runway, with funds expected to last only until the third quarter of 2025.

• There is uncertainty regarding which Annamycin dosing regimen will be most effective, requiring further data analysis.

• The company acknowledges the complexity of achieving early approval, as it requires a very statistically significant result in Part A of the trial.

Q & A Highlights

Q: What efficacy is required to pick one Annamycin dose at 45 patients rather than waiting until 90 if it doesn't happen at 45? A: Walter Klemp, CEO: If Annamycin performs as well in Part A as it did in the Phase 2 trial, and HiDAC performs as expected, we might hit the statistical significance required to accelerate approval. However, HiDAC might underperform due to being limited to one cycle. Paul Waymack, Senior Chief Medical Officer, added that it's a multivariable equation, and while early termination is possible, it's not highly likely.