Moleculin Biotech Inc (LTS:0K2H)

Q1 2025 Moleculin Biotech Inc Earnings Call Transcript

May 14, 2025 / 12:30 PM GMT

Release Date Price: $24.88 (-5.68%)

Transcript 8-K10-Q

Key Points

Positve

Moleculin Biotech Inc (MBRX) has officially started the Phase 3 Miracle trial for Anamycin, with the first patient already treated and 38 sites selected worldwide.
The European Medicines Agency has given complete sign-off for the trial in all nine EU countries, marking a significant milestone.
The World Health Organization has recognized a new generic drug name for Anamycin, Naxorubicin, aiding in its future market positioning.
Additional patent protection for Anamycin has been secured, extending its composition of matter protection into at least 2040.
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

Moleculin Biotech Inc (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.
The company faces potential delays in EU approval due to additional GLP preclinical data requested by the EMA.
There are minor differences between the US and EU protocols for the Phase 3 trial, which could complicate the harmonization process.
The company acknowledges that the development of an IV delivery for WP 1,066 could encounter speed bumps, potentially delaying progress.
The durability of complete remission in the MB 106 trial is still developing, with some patients relapsing after significant periods.

Refinitiv StreetEvents Event Transcript
E D I T E D V E R S I O N

MBRX.OQ - Moleculin Biotech Inc
Q1 2025 Moleculin Biotech Inc Earnings Call
May 14, 2025 / 12:30PM GMT

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Presentation
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Unidentified_1 [1]
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Good morning. Welcome to the molecular and Biotech 1st quarter 2025 update conference call and webcast.

Question and answer session will follow the formal presentation.

As a reminder this conference is being recorded.

It is now my pleasure to turn the call over to your host Janine Thomas, investor relations. Please go ahead, Janine.

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Unidentified_2 [2]
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Thank you, Robin. Good morning, everyone. At this time, I would like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs

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