Moleculin Biotech reports Q2 2026 loss of $7.6M, cash $7.3M; MIRACLE trial interim efficacy positive
I'm LongbridgeAI, I can summarize articles.Moleculin Biotech reported a Q2 2026 net loss of $7.6 million and held $7.3 million in cash, supplemented by a post-quarter $9.3 million raise funding operations into Q1 2027. Operationally, the company highlighted positive interim efficacy from its MIRACLE Phase 2/3 trial for Annamycin in relapsed/refractory AML, showing significantly higher complete remission rates than controls with no cardiotoxicity. Enrollment is on track for September 2026.
Moleculin Biotech reported second-quarter 2026 results showing a net loss of $7.6 million for the three months ended June 30, 2026 and cash and cash equivalents of approximately $7.3 million as of quarter-end. The company said it raised an additional $9.3 million after quarter-end and expects cash to fund operations into Q1 2027. Operationally, Moleculin highlighted positive interim unblinded efficacy from the pivotal MIRACLE Phase 2/3 trial of Annamycin, with higher complete remission rates versus control and no evidence of cardiotoxicity.
Financial Highlights
- Net loss (three months ended June 30, 2026): $7.635 million.
- Net loss available to common stockholders (three months ended June 30, 2026): $7.964 million.
- Six-month net loss (ended June 30, 2026): $20.480 million.
- Research and development expense (Q2 2026): $5.450 million; General and administrative expense (Q2 2026): $2.103 million.
- Cash and cash equivalents as of June 30, 2026: $7.262 million; subsequent financing proceeds: $9.3 million, which management expects to support operations into Q1 2027.
Business Highlights
- Reported positive preliminary unblinded efficacy from the first 45 patients in Part A of the MIRACLE Phase 2/3 trial evaluating Annamycin plus cytarabine in relapsed/refractory AML; both Annamycin arms showed CR rates at least three times higher than control (43% and 36% vs. 12%).
- Composite complete remission (CRc) in the interim cohort reached 50% and 57% in the two Annamycin cohorts versus 29% for control; interim population included substantial proportions of older patients and those with prior 1L regimens including 7+3 and venetoclax.
- Enrollment in Part A progressing toward the planned 90-patient milestone expected in September 2026, with unblinded efficacy readout for Part A expected in the December 2026–February 2027 timeframe.
- Company expects to select optimal Annamycin dose from Part A data and initiate Part B in the first half of 2027; Part B recruitment is targeted to complete in 2028 with primary efficacy readouts for 2nd line subjects in 2028 and rolling NDA submission to begin in 2028.
- Annamycin continues to show a differentiated cardiac safety profile with no detectable cardiotoxicity reported and favorable investigator feedback and market research indicating strong physician intent to prescribe based on efficacy and transplant-bridging potential.
Original SEC Filing: Moleculin Biotech, Inc. [ MBRX ] - 8-K - Aug. 14, 2026