Moleculin Posts Investor Deck: MIRACLE Part A Closed, 50% CR in Pooled AnnAraC Data, NDA Targeted 2028-2029
MBRX sits 92% above its 52-week low of $0.161 on light trading volume (0.3× avg).
Summary
Moleculin's updated investor presentation confirms MIRACLE Part A enrollment is closed, reports 50% CR in pooled AnnAraC data, and targets an NDA filing in 2028-2029 for Annamycin in relapsed/refractory AML.
Key Events · Product Development and Regulatory · MBRX
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MIRACLE Part A Enrollment Closed
Part A enrollment is complete; the first interim analysis (n=45) showed both Annamycin arms outperforming control on CR and CRe, and the IDMC recommended continuing without modification.
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Pooled AnnAraC Data: 50% CR
Pooled MB-106 and MB-108 data across 50 subjects show 41% CR and 60% CRe; the NDA is planned to be based on the CR rate in second-line subjects at approximately one month.
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Regulatory Timeline to NDA
The deck targets an unblinded 90-patient readout in September 2027, Part B start in September 2027, Part B readout in September 2028, and NDA filing in 2028-2029 with potential approval in 2029-2030.
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Market Opportunity Sized
Management estimates a ~$900M AML opportunity for Annamycin, expanding to ~$9.9B across pipeline indications, with payer research supporting ~$39K per infusion pricing.
Analysis · MBRX · Life Sciences
Moleculin furnished an updated corporate presentation that consolidates the clinical case for Annamycin ahead of the MIRACLE Part A unblinding. The deck discloses that Part A enrollment is closed, that both Annamycin arms beat control on CR and CRe at the first interim look (n=45), and that pooled MB-106 plus MB-108 data across 50 subjects show 41% CR and 60% CRe. It also lays out a concrete regulatory path: unblinded 90-patient readout in September 2027, Part B start in September 2027, Part B readout in September 2028, and NDA filing in 2028-2029. For a company trading at $0.31 with going-concern language and a Nasdaq delisting determination previously disclosed, this is the clearest articulation yet of the timeline and market opportunity (~$900M AML, ~$9.9B with pipeline) that the equity story rests on. The presentation is furnished under Item 7.01 and is not filed, so it carries no new financial obligations, but it does put updated efficacy and timeline numbers in front of investors.
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At the time of this filing, MBRX was trading at $0.31 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $7.5M. The 52-week trading range was $0.16 to $15.75. This filing was assessed with neutral market sentiment and an importance score of 7 out of 10.