The rapid enrollment completion de-risks the trial's operational execution and sets up a binary catalyst in Q1 2027. Monitor for any early safety/efficacy signals from the blinded data and the company's financing plans to fund through the readout.
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Executive Summary
Moleculin Biotech announced it has completed and closed enrollment in Part A of its pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in combination with cytarabine for relapsed/refractory AML, with 89 subjects enrolled. The company remains on track for a comprehensive data readout in Q1 2027, which will be a key catalyst for the stock.
Key Facts
- Completed and closed enrollment in Part A of the pivotal Phase 2/3 MIRACLE trial with 89 subjects enrolled and two additional subjects in screening.
- Comprehensive data readout for Part A remains on track for the first quarter of 2027.
- The final Part A dataset is expected to approximate a 50/50 split between subjects previously treated with intensive 7+3 chemotherapy and those treated with venetoclax-based regimens.
- Company reports continued absence of cardiotoxicity in blinded MIRACLE data.
- The expanded Part A dataset (89 subjects) is substantially larger than the first interim n45 readout.
Financial Impact
No financial data provided; the filing is an operational milestone update for a clinical-stage biotech. The next major catalyst is the Q1 2027 data readout.
Risk Factors
- The company requires significant additional financing to continue operations and has no commitments for such financing.
- The shift in Part A composition to more 'unfit' subjects (expected 50/50 split vs. prior 70/30) represents a more challenging environment for achieving treatment responses.
- Absolute remission rates are expected to be lower than historical multi-cycle benchmarks due to the single-cycle protocol design.
- The data readout is binary — positive data could be transformative, but negative data would be severely detrimental.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-031419 |
| Exhibit: ex_1020544.htm | 0001437749-26-031419 |
| Document: 0001437749-26-031419-index-headers.html | 0001437749-26-031419 |
| Document: 0001437749-26-031419-index.html | 0001437749-26-031419 |
| Document: 0001437749-26-031419.txt | 0001437749-26-031419 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 20, 2026 7d ago | 8-K | $6.19 | awaiting T+20 | — | $9.27 (+49.68%) |
Oct 16, 2026 11d ago | 8-K | $0.2804 | awaiting T+20 | — | $9.27 (+3204.21%) |
Oct 9, 2026 18d ago | 8-K | $0.4139 | awaiting T+20 | — | $9.27 (+2138.46%) |
Oct 5, 2026 22d ago | 8-K | $0.4766 | awaiting T+20 | — | $9.27 (+1843.98%) |
Sep 29, 2026 28d ago | 8-K | $0.5264 | awaiting T+20 | — | $9.27 (+1660.07%) |
Sep 29, 2026 28d ago | Press Release | $0.5264 | awaiting T+20 | — | $9.27 (+1660.07%) |
Sep 28, 2026 29d ago | 8-K | $0.5690 $7.09 | ▲ +1145.17% | ▲ +1145.20% | $9.27 (+1528.30%) |
Sep 25, 2026 4w ago | 8-K | $0.6016 $6.50 | ▲ +980.45% | ▲ +981.93% | $9.27 (+1440.06%) |
Sep 23, 2026 4w ago | 8-K | $0.5279 $6.31 | ▲ +1095.30% | ▲ +1094.61% | $9.27 (+1655.07%) |
Sep 18, 2026 5w ago | 8-K | $0.5202 | awaiting T+20 | — | $9.27 (−1681.05%) |
US Market Status
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