Moleculin Biotech Reports $6.4 Million Net Loss in Q1 2025, Seeks Additional Funding

Moleculin Biotech, Inc. reported its financial results for the first quarter of 2025, revealing a net loss of $6.4 million, compared to a net loss of $5.0 million for the same period in 2024. The company did not generate any revenue during this quarter, consistent with its previous fiscal periods. Operating expenses decreased to $5.9 million from $6.7 million year-over-year, primarily due to reduced research and development costs, which fell from $4.3 million to $3.4 million. General and administrative expenses saw a slight increase from $2.4 million to $2.5 million, attributed to higher regulatory and legal fees.

Significant changes in the company's financial position were noted, particularly in its cash reserves, which increased to $7.7 million as of March 31, 2025, up from $4.3 million at the end of 2024. This increase was largely driven by financing activities, which provided $8.0 million in cash during the quarter, including proceeds from the exercise of warrants and the sale of common stock. The total liabilities also rose sharply to $21.0 million from $10.9 million, primarily due to an increase in the long-term warrant liability, which grew from $5.2 million to $13.7 million.

Moleculin is currently focused on advancing its lead drug candidate, Annamycin, through a pivotal Phase 3 trial for the treatment of relapsed/refractory acute myeloid leukemia (AML). The company has expanded its clinical trial sites to 38 across the U.S., Europe, and the Middle East, with plans for interim data unblinding expected by the end of 2025. Additionally, the European Medicines Agency has approved the company's Clinical Trial Application to conduct the MIRACLE trial in nine EU countries, further broadening its operational footprint.

The company’s employee headcount has also seen a notable increase, with 14.1 million shares outstanding as of March 31, 2025, compared to 3.4 million shares at the end of 2024. This increase reflects the exercise of warrants and the issuance of new shares as part of its financing strategy. Despite these developments, Moleculin's management has expressed concerns regarding its ability to continue as a going concern, citing the need for approximately $15 million in additional funding to support ongoing operations and clinical trials into early 2026.

Looking ahead, Moleculin Biotech is actively seeking various funding avenues, including equity offerings and strategic partnerships, to ensure the continuation of its clinical programs and operational activities. The company remains committed to its research and development efforts, particularly in the area of hard-to-treat cancers, while navigating the challenges posed by market conditions and regulatory requirements.