Moleculin Biotech, Inc.

Moleculin did not provide revenue, EPS, or gross margin figures on this call, consistent with its clinical-stage profile. The company ended the quarter with about $8 million in cash on hand, which management said should fund operations into the third quarter of 2025. CFO Jonathan Foster said the company would need to raise approximately $15 million to get well into the first quarter of 2026, and that this would support the program beyond the initial 45-subject data readout and into 75-90 recruited subjects. Management also noted the AMMNYCIN/naxtarubicin trial in Part A will use two dose levels, 190 mg/m^2 and 230 mg/m^2, with an interim unblinding after the first 45 patients and another after 75-90 patients.

Walter Klemp framed Annamycin as the company’s core value driver and emphasized that MIRACLE is now underway, with global site selection largely complete and EU regulatory progress described as a major milestone. He repeatedly stressed that the first 45-patient unblinding is the most important near-term event and said the company expects to reach that point before year-end. His tone was highly optimistic, positioning Annamycin as a potentially first-in-class, non-cardiotoxic anthracycline with broad market relevance and saying the company is focused on pushing Moleculin’s market cap to a level he believes it deserves.

Jonathan Foster focused on liquidity, stating the quarter ended with about $8 million in cash and that this should carry operations into the third quarter of 2025. He said the company would need roughly $15 million to extend runway into the first quarter of 2026, which he linked to funding through the first 45-subject readout and additional enrollment toward 75-90 subjects. He also highlighted a market cap of over $14 million, 14.1 million shares outstanding, and said trading volume had been healthy, with roughly 2.4 million shares traded on the prior Monday after the EU news. Foster added that R&D spending should rise, especially into 2026 as GLP and manufacturing costs increase.

Analysts pressed management on whether the EMA’s request for additional GLP data could slow EU timing, and management said it should not materially change the overall timeline, though it depends on how quickly the GLP work is completed. Questions also focused on WP1066’s IV formulation; management said it is now in the implementation stage and that investors should expect to hear more before year-end, while acknowledging development speed bumps are possible. On MIRACLE’s endpoints, management said durability is secondary and not required for approval, and they argued the control arm CR rate should be in the teens, likely lower than the 17.5% cited from prior trials because Moleculin’s design uses only one cycle of cytarabine before assessment. They also said the trial will not exclude venetoclax failures and will stratify by age and mutations, but the primary endpoint is not dependent on those factors.