The Q1 2027 Part A data readout is the next major binary catalyst. The shift to more 'unfit' subjects (50/50 vs prior 70/30) may lower absolute remission rates but could broaden the addressable label if efficacy holds. Monitor for any financing needs ahead of the readout.
Price Chart
Executive Summary
Moleculin announced completion of Part A enrollment in the pivotal Phase 2/3 MIRACLE trial of Annamycin for R/R AML, with 89 subjects enrolled and a comprehensive data readout expected in Q1 2027. The filing contains no financial results — the EPS miss of -6215.8% vs consensus is a mechanical artifact of a pre-revenue clinical-stage biotech with minuscule absolute EPS, not a business deterioration signal.
Key Financial Metrics
Key Facts
- Part A enrollment completed with 89 subjects enrolled; one additional subject in screening
- Comprehensive Part A data readout expected in Q1 2027
- Estimated 50/50 split between 'fit' (prior 7+3) and 'unfit' (prior venetoclax-based) subjects in full Part A population, vs ~70/30 in first 45 subjects
- No cardiotoxicity observed in blinded data to date
- EPS reported at -$28.00 vs consensus -$0.44; revenue $0 (pre-revenue clinical-stage company)
Financial Impact
No financial data reported; pre-revenue clinical-stage biotech with no product sales. The EPS miss is a mechanical artifact of share-count changes and one-time items on a minuscule absolute base.
Risk Factors
- Shift in Part A composition to more 'unfit' subjects may reduce absolute remission rates vs prior interim data
- Company requires significant additional financing with no commitments; cash runway risk
- Single-cycle therapy design may produce lower absolute remission rates than multi-cycle historical benchmarks
- Pre-revenue stage with no product sales; stock price driven entirely by trial outcomes
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3370867 |
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 17d 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 $7.09 | ▲ +1145.17% | ▲ +1145.20% | $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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