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- **Breakthrough Trial Momentum**: 38 global sites activated for MIRACLE trial; 9 EU countries approved by EMA. First interim data (45 patients) expected by end-2025.
- **Annamycin Commercialization**: Secured new WHO name 'naxtarubicin'; extended patent protection to 2040+. Final sarcoma trial data imminent.
- **Financial Sustainability**: $8M cash runway; $15M raise needed for 2026 recruitment. Trading volume surges post-EU news.
- **Clinical Differentiation**: 50% CR rate in Phase 2 vs. 17.5% control arm; no exclusions for challenging patient subgroups.
- **Pipeline Expansion**: WP1066 IV formulation development on track; Phase 3 trial data expected H2 2026.


**【CEO Opening Remarks】**
- **MIRACLE Trial Milestones**: 38 global sites activated (US, EU, MENA), with EMA approval for 9 EU countries. First patient treated in Ukraine; target 45 interim patients by end-2025.
- **Annamycin Updates**: New WHO generic name 'naxtarubicin' established; additional patent protections extended to 2040+. Final data from MB-107 sarcoma trial expected soon.
- **Pipeline Expansion**: WP1066 STAT3 inhibitor in radiation combo trial at Northwestern (7 patients enrolled); IV formulation development with Emory University.

**【CFO Financial Update】**
- **Cash Position**: $8M as of Q1; current runway to Q3 2025. $15M raise needed to fund through 75-subject interim readout (H2 2026).
- **Market Dynamics**: $14M market cap with 14.1M shares outstanding; 3M shares/day trading volume. Notable volume spike (2.4M shares) post-EU approvals.
- **Operational Efficiency**: 17-employee team executed EU approvals on schedule; focus on site activations and recruitment acceleration.

**【Q&A Key Takeaways】**
1. **EMA Timeline Clarification**: Additional GLP studies required for Part B but not expected to delay EU approval; US recruitment continues in parallel.
2. **WP1066 Formulation Progress**: Emory IV delivery development on track for potential 2025 clinic entry; preclinical work prioritized.
3. **R&D Spend Outlook**: Q1 R&D at $3.5M; expect increase in 2026 for GLP studies and manufacturing scale-up.
4. **Primary Endpoint Focus**: FDA approval based on Day 35 CR rate (vs. 17.5% control arm); durability secondary but expected to mirror Phase 2 (median >400 days).
5. **Patient Inclusion Strategy**: No exclusions for venetoclax failures or elderly; Phase 2 data shows consistent 50% CR across subgroups.


Moleculin Biotech, Inc. (MBRX) Q1 2025 Earnings Call Transcript

- **Pivotal Trial Progress**: MIRACLE Phase 3 trial enrolling globally, with first patient in Q1 2025 and interim data at 45 and 75-90 subjects.
- **Phase 2 Efficacy**: 50% CR rate vs. 17.5% control, 11-month OS, and no cardiotoxicity in relapsed AML.
- **Financial Position**: $13M cash runway through Q3 2025, with cost-efficient execution of trial milestones.
- **Strategic Focus**: Annamycin as first non-cardiotoxic anthracycline, targeting both AML and soft tissue sarcoma indications.

**【CEO Opening Remarks】**
- Launched MIRACLE Phase 3 pivotal trial for Annamycin in relapsed/refractory AML, with 25 global sites activated (first European country approved, US enrollment to lag due to regulatory timelines).
- First patient expected to be treated in Q1 2025; interim data unblinding at 45 and 75-90 subjects to provide early efficacy visibility.
- Phase 2 data shows 50% CR rate vs. 17-18% for current therapies, with 11-month OS and no cardiotoxicity.
- Annamycin overcomes Venetoclax resistance, positioning as first non-cardiotoxic anthracycline.

**【CMO Clinical Update】**
- Phase 2 (MB106): 50% CR rate vs. 17.5% control arm, 9-month PFS, 78% MRD-negative responses.
- Phase 3 (MIRACLE): Randomized trial comparing 190mg/m² vs. 230mg/m² Annamycin + HiDAC vs. placebo + HiDAC.
- Primary endpoint: CR at Day 35; Part A interim analysis to select optimal dose, Part B randomized 222 patients.
- Potential for early unblinding if interim data shows statistical significance.

**【CFO Financial Overview】**
- Cash balance of $13M (Q4 2024 + $9M Feb 2025 raise), supporting Q2 2025 operations.
- 2024 OpEx reduced by $3M vs. 2023; 2025 milestones include trial site activations, first patient enrollment, and interim data reads.
- WP1066 and WP1122 programs externally funded, focusing resources on Annamycin NDA preparation.

**【Q&A Key Takeaways】**
- Dose selection rationale: 230mg/m² based on Phase 2 success, 190mg/m² as FDA-suggested lower threshold.
- Trial cost: ~$60-70M if fully enrolled, but mid-2025 data readouts could accelerate partnerships.
- Expansion to frontline AML: Potential post-NDA approval, leveraging Annamycin's cardiotoxicity-free profile.
- Soft tissue sarcoma trial: 300mg/m² monotherapy showing promise, European investigator-led pivotal trial in planning stages.

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