In This Article:
Release Date: May 14, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Moleculin Biotech Inc (NASDAQ:MBRX) has officially started the Phase 3 Miracle trial for Anamycin, with the first patient already treated and 38 sites selected worldwide.
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The European Medicines Agency has given complete sign-off for the trial in all nine EU countries, marking a significant milestone.
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The World Health Organization has recognized a new generic drug name for Anamycin, Naxorubicin, aiding in its future market positioning.
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Additional patent protection for Anamycin has been secured, extending its composition of matter protection into at least 2040.
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The company is progressing with WP 1,066, a lead statory inhibitor, which is showing promise in treating brain tumors and is in a new clinical trial at Northwestern University.
Negative Points
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Moleculin Biotech Inc (NASDAQ:MBRX) ended the quarter with $8 million in cash, which will only sustain operations into the third quarter of the year, necessitating a $15 million raise.
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The company faces potential delays in EU approval due to additional GLP preclinical data requested by the EMA.
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There are minor differences between the US and EU protocols for the Phase 3 trial, which could complicate the harmonization process.
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The company acknowledges that the development of an IV delivery for WP 1,066 could encounter speed bumps, potentially delaying progress.
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The durability of complete remission in the MB 106 trial is still developing, with some patients relapsing after significant periods.
Q & A Highlights
Q: Does the requirement for additional GLP preclinical data by the EMA affect the timeline for EU approval compared to the US? A: Walter Klimt, CEO: We don't believe it will negatively impact the timeline. The EMA requested additional GLP preclinical data, which we can produce. While this could theoretically delay the EU's progression to Part B, we plan to continue recruiting in the US and non-EU sites during this period. Thus, the trial should not slow down, and we expect to meet EU patient requirements without affecting the approval timeline.
Q: How close is Emory University to developing an optimal formulation for WP 1,066? A: Walter Klimt, CEO: We are beyond the discovery phase and are now implementing a strategy for a new formulation suitable for IV delivery. We aim to have progress by the end of the year, although there could be unforeseen delays. We expect to provide updates before the year ends.