Moleculin Biotech (MBRX) Q1 2026 earnings summary

Executive summary

• Lead drug candidate Annamycin advanced in pivotal Phase 2B/3 MIRACLE trial for relapsed/refractory AML, achieving enrollment of 45 subjects and reporting strong early efficacy and safety signals, with interim unblinding expected mid-2026.

• Preliminary blinded data show a 40% composite complete remission rate in a difficult-to-treat AML population.

• Clinical trial operations expanded in the US and Europe, with global IP strategy for Annamycin strengthened and new Hong Kong patent issued, extending protection through 2040.

• Additional pipeline programs, including WP1066 and WP1122, continue development for cancer and viral diseases, with new data presented at major scientific meetings.

• Closure of Australian subsidiary approved to reduce overhead, focusing resources on core US and European operations.

Financial highlights

• Net loss for Q1 2026 was $12.8 million, compared to $5.9 million in Q1 2025, driven by higher R&D expenses and warrant-related charges.

• Research and development expenses increased to $5.4 million from $3.4 million year-over-year, mainly due to MIRACLE trial costs in Europe.

• General and administrative expenses were stable at $2.5 million year-over-year.

• Cash and cash equivalents were $10.3 million as of March 31, 2026, up from $8.9 million at year-end 2025.

• Net cash used in operating activities was $6.1 million, with $7.6 million raised from warrant exercises and ATM equity sales.

Outlook and guidance

• MIRACLE trial interim unblinding for 45 subjects expected in Q2 2026; 90th subject enrollment and unblinding anticipated in Q3 2026.

• Part B of MIRACLE trial and a pancreatic cancer clinical trial to begin in 2H 2026.

• Cash on hand plus recent ATM proceeds expected to fund operations into Q3 2026; additional $25 million needed to support MIRACLE trial and operations into Q1 2027.

• Rolling NDA submission for Annamycin in AML targeted for 2028.

• Ongoing focus on advancing Annamycin and leveraging external funding for other pipeline assets.