Monitor for unblinding results before June 30, 2026 – positive data could drive substantial upside given small market cap. Risk of dilution remains as company needs additional financing.
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Executive Summary
Moleculin Biotech announced preliminary blinded data from its pivotal Phase 2B/3 MIRACLE trial for Annamycin in relapsed/refractory AML, showing a complete remission rate of approximately 30% vs historical ~17-18% for standard of care. The first unblinding of 45 subjects is expected before June 30, 2026, representing a potential catalyst. Recruitment is on track with 56 of 90 subjects enrolled.
Key Facts
- Preliminary blinded CR rate approximates 30%, representing ~67% improvement over historical benchmarks of ~17-18%
- First data unblinding of 45 subjects expected before June 30, 2026
- 56 subjects recruited to date (62% of Part A target of 90 subjects)
- Trial includes two Annamycin doses + cytarabine vs cytarabine + placebo
- Over 30% of enrolled patients had prior venetoclax treatment, a challenging subgroup
Financial Impact
No revenue reported; clinical milestone could significantly affect stock price for this $12M market cap biotech
Risk Factors
- Unblinded data may not confirm preliminary blinded results
- Company requires significant additional financing with no commitments
- Clinical trial risk: failure to meet primary endpoint
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-016535 |
| Exhibit: ex_960684.htm | 0001437749-26-016535 |
| Document: 0001437749-26-016535-index-headers.html | 0001437749-26-016535 |
| Document: 0001437749-26-016535-index.html | 0001437749-26-016535 |
| Document: 0001437749-26-016535.txt | 0001437749-26-016535 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 20, 2026 6d ago | 8-K | $6.19 | awaiting T+20 | — | $7.09 (+14.46%) |
Oct 16, 2026 10d ago | 8-K | $0.2804 | awaiting T+20 | — | $7.09 (+2426.75%) |
Oct 9, 2026 16d ago | 8-K | $0.4139 | awaiting T+20 | — | $7.09 (+1611.77%) |
Oct 5, 2026 21d ago | 8-K | $0.4766 | awaiting T+20 | — | $7.09 (+1386.57%) |
Sep 29, 2026 27d ago | 8-K | $0.5264 | awaiting T+20 | — | $7.09 (+1245.93%) |
Sep 29, 2026 27d ago | Press Release | $0.5264 | awaiting T+20 | — | $7.09 (+1245.93%) |
Sep 28, 2026 28d ago | 8-K | $0.5690 | awaiting T+20 | — | $7.09 (+1145.17%) |
Sep 25, 2026 4w ago | 8-K | $0.6016 $6.50 | ▲ +980.45% | ▲ +981.93% | $7.09 (+1077.69%) |
Sep 23, 2026 4w ago | 8-K | $0.5279 $6.31 | ▲ +1095.30% | ▲ +1094.61% | $7.09 (+1242.11%) |
Sep 18, 2026 5w ago | 8-K | $0.5202 | awaiting T+20 | — | $7.09 (−1261.98%) |
US Market Status
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