Moleculin Biotech ((MBRX)) has held its Q4 earnings call. Read on for the main highlights of the call.
Moleculin Biotech’s recent earnings call exuded a positive sentiment, driven by promising developments in their clinical trials and a robust financial standing. The company highlighted encouraging data from the Phase 2 trial of Annamycin and the commencement of the MIRACLE Phase 3 trial. Despite these advancements, challenges such as delayed enrollment in the US and the high costs associated with the Phase 3 trial were acknowledged.
Launch of MIRACLE Phase 3 Trial
Moleculin Biotech has initiated the MIRACLE Phase 3 pivotal trial for Annamycin, in combination with Cytarabine, targeting second-line treatment for relapsed and refractory AML patients. The trial has received regulatory and ethics approval in its first European country, with patient screening already underway.
Positive Phase 2 Data for Annamycin
The Phase 2 trial data for Annamycin is promising, showing a 50% complete remission rate in second-line AML patients. The median progression-free survival was reported at nine months, with overall survival at 11 months, outperforming existing therapies with a comparable complete remission rate.
Strong Financial Position
Moleculin Biotech has strengthened its financial position by raising approximately $9 million in February 2025, resulting in a combined cash balance of $13 million. This financial boost extends the company’s runway into the third quarter of 2025.
Potential Game-Changer for AML Treatment
Annamycin is emerging as a potential game-changer in AML treatment, showing no drug-related cardiotoxicity and overcoming resistance to Venetoclax. It is recognized as potentially the first non-cardiotoxic anthracycline, with experts acknowledging its significance.
Pipeline and Future Milestones
Moleculin is focused on operational execution and meeting its milestones, with plans to release data from MB107 in April and develop a pivotal investigator-initiated trial in Europe later in 2025.
Delayed US Enrollment in MIRACLE Trial
The US is expected to be one of the last countries to begin enrolling patients in the MIRACLE Phase 3 trial due to longer approval processes involving institutional review boards and hospital contract negotiations.
High Cost of Phase 3 Trial
The Phase 3 trial is expected to cost between $60 million and $70 million, with anticipated cash burn increasing to $7 million or $8 million per quarter in 2026.
Forward-Looking Guidance
Moleculin Biotech provided detailed guidance on the MIRACLE Phase 3 trial’s progress, set across 25 sites in the US, Europe, and the Middle East. The trial includes multiple unblindings of data to enhance stakeholder visibility, with the first unblinding expected by the end of 2025. The company aims to maintain a cash burn of $5 million per quarter, increasing as the trial progresses.
In summary, Moleculin Biotech’s earnings call highlighted a positive outlook, driven by promising clinical trial data and a solid financial position. The company is poised to make significant strides in AML treatment with Annamycin, despite facing challenges related to trial costs and US enrollment delays.