Moleculin Biotech Misses Fiscal Q2 EPS

Moleculin Biotech (MBRX 1.37%), a clinical-stage pharmaceutical developer focused on oncology, released its second quarter 2025 results on August 13, 2025.

The biggest news from this update was a GAAP net loss of $(7.6) million.

Reported GAAP EPS of $(0.49) missed the analyst estimate of $(0.40), falling short by $0.09 or 22.3%. As expected, there was no revenue. The overall quarter brought expanded clinical activity and important regulatory developments, but it also highlighted the company’s growing reliance on external funding and balance sheet pressures.

Source: Analyst estimates for the quarter provided by FactSet.

Company Overview and Strategic Focus

Moleculin Biotech is a clinical-stage biotechnology company developing new drugs aimed at treating resistant cancers and rare tumors. Its approach centers on small-molecule therapies, with a key focus on compounds that could overcome resistance to existing treatments.

The company’s main asset is Annamycin, a next-generation anthracycline drug being tested in acute myeloid leukemia (AML) and soft tissue sarcoma with lung metastases. It is also advancing WP1066, an experimental drug for brain tumors. Moleculin is highly dependent on steady clinical trial progress and the ability to turn promising laboratory data into regulatory approvals. Forming partnerships with institutions like MD Anderson Cancer Center has helped boost its technical capabilities. Success in clinical trials, regulatory approvals, and new collaborations will be vital for future prospects.

Second Quarter 2025 Highlights: Financial Results and Pipeline Progress

The quarter was marked by a large operational push to expand enrollment in the pivotal MIRACLE trial for Annamycin, chasing critical milestones that could shape the company’s future. On the clinical side, management reached a significant milestone by securing approval from the European Medicines Agency to run its pivotal trial in nine European Union countries, while also starting patient dosing both in the U.S. and abroad. There were four active MIRACLE trial sites, with plans to expand to more than 20 before the end of Q3 2025.

Key regulatory developments included positive feedback from the U.S. Food and Drug Administration (FDA) on a pediatric AML trial plan set for 2027, as well as a reduction in the required number of patients for phase 3 approval to 222.

Interim results continue to show signs of efficacy. In a completed phase 1B/2 study (MB-106), the Annamycin regimen demonstrated a 50% complete remission rate in AML, compared to the 17.5% rate typical for older standard therapies. The study of Annamycin in soft tissue sarcoma lung metastases (MB-107) reported a median overall survival of 13.5 months for patients who had already undergone multiple prior treatments, with a median of 7th line therapy (n=36). For WP1066 (a STAT3 inhibitor), clinical work remains in early trial stages, with ongoing enrollment at Northwestern University and preclinical work at Emory University for a new intravenous formulation. No efficacy data has been released for WP1066 yet.

From a financial perspective, the company remains in a pre-commercial stage, which means it reports zero revenue.

Research and development expenses (GAAP) declined to $3.6 million for the three months ended June 30, 2025, compared to $4.1 million in the same period of 2024.

General and administrative expenses remained steady at $2.12 million (GAAP). Despite reduced operating expenses, net losses deepened to $(7.6) million (GAAP), largely due to non-cash charges related to issued warrants. The share count grew sharply to 15.5 million, up from just 2.5 million a year ago, reflecting heavy dilution from equity and warrant issuances, based on weighted average common shares outstanding (GAAP) for the respective periods.

One key financial update was the company's warrant liability, which reached $20.6 million (GAAP) as of the end of Q2 2025.

The equity position moved into deficit—stockholder equity (GAAP) was $(7.2) million at the end of Q2 2025, compared to a $6.0 million surplus at the end of Q4 2024. Cash and cash equivalents rose to $7.56 million as of the end of Q2 2025, but management cautioned this is only enough to fund operations until the fourth quarter of 2025. The result is a clear warning: additional capital will need to be raised soon, or clinical trial progress could stall.

No material one-time gains or losses were disclosed outside of warrant-related accounting impacts. The company reported no revenue and no changes to dividend policy, as it does not currently pay a dividend.

Products in Focus: Clinical Pipeline and Recent Developments

Annamycin is a novel anthracycline-type chemotherapy that aims to treat cancers, especially in cases where tumors have become resistant to traditional drugs or when existing therapies cause significant side effects such as heart damage. It is now being tested in both relapsed / refractory acute myeloid leukemia and soft tissue sarcoma lung metastases. The pivotal MIRACLE trial marks Moleculin’s top priority. The company expanded the number of trial sites and is progressing toward the first pivotal data readout before the end of the year, with the goal of providing interim results on 45 patients by late 2025 and conducting a further unblinding with 75-90 patients in the first half of 2026.

WP1066, another key candidate, is a STAT3 inhibitor being evaluated for brain tumors like glioblastoma. The trial is being conducted externally at Northwestern University, with enrollment ongoing and additional preclinical formulation work underway at Emory University. Although no new partnerships were announced this quarter, ongoing collaborations with leading cancer centers and university hospitals remain a central part of Moleculin’s approach to progress clinical programs and reduce costs.

Pertinent regulatory and intellectual property progress included positive FDA interaction for both adult and pediatric strategies, a reduction in required patient numbers for final approval, and fresh patent grants covering methods for preparing and administering Annamycin. Orphan Drug and Fast Track designations remain in place for key programs, potentially allowing for faster review and longer market exclusivity if the drugs are ultimately approved.

The competitive context remains challenging. However, the ultimate goal of regulatory approval will depend on successful completion of pivotal studies, patient recruitment rates, and the company’s ability to secure additional funding. Management specifically noted the risk of delays if required capital cannot be raised quickly enough for planned activities like expanding clinical sites and conducting new studies.

Outlook and What to Watch Going Forward

Management did not provide detailed forward financial guidance for the upcoming quarter or for the full year. However, management reiterated that current cash is sufficient for operations only through Q4 2025 and noted the need for a significant capital raise in the near term. All future project timelines and trial expansions assume that the company will obtain this additional financing without delay.

The near-term focus remains clinical: opening more trial sites and enrolling patients for the MIRACLE study, reporting unblinded interim efficacy and safety results later this year, and defining the next steps for its soft tissue sarcoma program. Investors should closely watch updates on patient recruitment, interim data releases, and, just as importantly, signs of successful fundraising. The outcome of these efforts will determine whether Moleculin can maintain momentum in its clinical development and advance its strategy to bring innovative cancer treatments closer to market. MBRX does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.