Moleculin Biotech (MBRX) Q2 2026 earnings summary

Executive summary

• Interim data from the pivotal Phase 2/3 MIRACLE trial showed Annamycin achieved complete remission rates three times higher than control in relapsed/refractory AML, with strong physician and payer interest and no cardiotoxicity observed even at high doses.

• MIRACLE trial enrollment is on track to reach 90 patients by September 2026, with unblinded efficacy data expected between December 2026 and February 2027.

• Additional portfolios target hard-to-treat cancers and viruses, with ongoing and planned investigator-initiated trials and preclinical research.

• Closed Australian subsidiary to reduce overhead, with future activities focused in the US, Europe, and possibly the Middle East.

• Strong investigator engagement and enthusiasm for Annamycin, with market research indicating high intent to prescribe.

Financial highlights

• Net loss for Q2 2026 was $7.96 million, compared to $17.8 million in Q2 2025; net loss for the first half of 2026 was $20.5 million, down from $23.7 million in the prior year.

• Operating expenses rose to $7.6 million in Q2 2026 from $5.7 million in Q2 2025, driven by increased R&D for the MIRACLE trial.

• Cash and cash equivalents were $7.3 million as of June 30, 2026, with an additional $9.3 million raised after quarter-end.

• Net cash used in operating activities was $12.8 million for the first half of 2026, up from $10.1 million in 2025.

• Financing activities provided $11.2 million in the first half of 2026, including warrant exercises and ATM equity sales.

Outlook and guidance

• Cash on hand plus $9.3 million raised in August 2026 expected to fund operations into Q1 2027; additional $8 million needed to support operations into Q2 2027.

• MIRACLE Part B initiation is planned for the first half of 2027 after optimal dose selection.

• Key milestones include completion of Part A enrollment in September 2026, data unblinding by early 2027, and NDA submission beginning in 2028.

• Continued focus on advancing Annamycin through MIRACLE trial and supporting other programs via external funding.