Moleculin Biotech, Inc. Q1 FY2025 earnings call

• Phase 3 MIRACLE trial for Annamycin in R/R Acute Myeloid Leukemia has started with first patient treated; 38 sites selected globally, EU approval from EMA for 9 countries, WHO recognized new generic name naxtarubicin for Annamycin, additional patent protection for Annamycin. • Upcoming announcement of final data from MB-107 clinical trial for advanced soft tissue sarcoma. • WP1066 in investigator-sponsored clinical trial with radiation at Northwestern University, recruiting 7 patients; collaborating with Emory University on IV delivery for WP1066. • MB-106 Phase 2 trial: First patient achieved complete remission lasting over 600 days; durability still developing with final three subjects in complete remission. • MIRACLE trial details: Treating initial refractory relapsed AML subjects, recruitment underway, initial safety/efficacy readout expected end of 2025; EU approval for trial, minor protocol differences between US and EU, primary endpoint is 35-day complete remission rate. • Financials: Cash on hand ~$8 million, needs ~$15 million to run operations into 2026; market cap over $14 million, trading volume healthy.

No traditional product segment financial performance reported; focus on drug candidates Annamycin and WP1066 with ongoing clinical trials and development activities.

• Need to raise ~$15 million to support operations into third quarter 2026 and get to initial 45-subject data readout. • Expect to announce final data from MB-107 clinical trial in coming weeks. • Anticipate initial 45-patient unblinding by end of 2025.

• Delays in GLP preclinical data for EU Part B of MIRACLE trial. • Uncertainties in formulation development for WP1066. • Dependencies on regulatory approvals and clinical trial results.

Q: Statement about results submitted as substantial modification to EMA, impact on EU vs US timeline?

A: We don't think it will change the timeline significantly. EMA requested GLP preclinical data, but trial can continue recruiting in US and non-EU sites; while timing of GLP studies could affect, we expect it won't alter approval timeline drastically.

Q: How close is Emory to optimal formulation for WP1066?

A: We think we're beyond the discovery stage and implementing a strategy for IV delivery. Expect progress by end of 2025, but development can have speed bumps.

Q: Primary endpoint 35-day CR rate, need for durability data?

A: Durability is a secondary endpoint; primary is 35-day complete remission rate. FDA focuses on CR rate, which we expect to be strong. Durability is a trend, not a primary approval factor.

Q: Impact of age, genetic mutations on data announcement?

A: We will stratify by age and mutations, but primary endpoint isn't dependent on them. We include all patients regardless of age, genetic mutations, or prior therapies like venetoclax failures.