The 40% CRc rate is encouraging for a high-risk AML population, but remains blinded and preliminary. Traders should monitor the mid-2026 interim unblinding as a key catalyst. Despite cash runway extension, the company will need further financing, creating potential dilution risk.
Price Chart
Executive Summary
Moleculin Biotech reported financial results for 2025, showing a net loss of $33.6 million and reduced R&D spending. The company highlighted a 40% preliminary blinded CRc rate in the first 30 patients of its MIRACLE Phase 3 trial for Annamycin in relapsed/refractory AML, with interim unblinding expected in mid-2026. With $8.9 million in cash as of year-end and $8.3 million raised in Q1 2026, the company expects funding into Q3 2026.
Key Financial Metrics
Key Facts
- Preliminary blinded CRc rate of 40% in first 30 MIRACLE trial patients with R/R AML, including 35% venetoclax-failed cases
- Interim unblinding of 45-subject data expected in mid-2026, a key near-term catalyst
- Net loss widened to $33.6 million in 2025 from $26.0 million in 2024, driven by $30.9 million loss on warrant liabilities
- Cash and equivalents: $8.9 million as of Dec 31, 2025; $8.3 million raised in Q1 2026 financing
- R&D expenses decreased to $15.9 million from $17.7 million in 2024 due to lower sponsored research
Financial Impact
Net loss of $33.6 million in 2025, with $30.9 million tied to warrant liability losses; cash runway extended into Q3 2026 with recent financing
Risk Factors
- Preliminary efficacy data is blinded and based on only 30 patients; may not hold upon unblinding
- Company has a history of significant losses and will require additional financing, likely dilutive
- Warrant liability accounting created a $30.9 million loss in 2025, indicating complex capital structure risks
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3259011 |
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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