Moleculin Biotech, Inc. Q1 FY2024 earnings call

• Locked in composition of matter patent protection for annamycin with market exclusivity through 2040, plus orphan drug designations in the U.S. and EU.
• Treated over 80 patients with 0 cardiotoxicity, achieving a 60% CRc rate in second-line AML patients.
• Requesting the FDA to agree to an open-label single-arm trial of around 100 to 150 patients as the pivotal approval trial for second-line AML.
• Compared the company's valuation to others in the AML space, highlighting the disparity in valuations despite better data.
• R&D expense for the quarter was $4.3 million vs $5.7 million same period a year ago; G&A expense was $2.4 million vs $2.6 million same period prior year; cash on hand was roughly $17 million.

No detailed product segment financial performance or revenue contribution % discussed as the transcript does not break down by product segments

• Plan to kick off the pivotal trial by the end of 2024 if the FDA provides a supportive response.
• Expect critical news flow on progress.
• Intend to have the End of Phase II meeting by the end of June and share feedback in early Q3.
• Plan to give an update on the MB-106 first-line patients in August with quarterly earnings.

• Forward-looking statements involve risks and uncertainties where actual results could differ materially.
• Clinical trial data discussed is preliminary and subject to change.
• There was a rare allergic reaction event in one patient, which could potentially impact trial numbers.
• The FDA may have concerns about the combination therapy requiring a randomized trial.

Q: Has there been anything else even remotely akin to allergic reactions?

A: No new information, but there was a typical allergic reaction in one patient, a rare event, and explained by intent-to-treat analysis.

Q: When is the End of Phase II meeting and related updates?

A: Expect to have the End of Phase II meeting by the end of June, with feedback in early Q3; likely no additional MB-106 data before then.

Q: Comparison to approved second-line drugs?

A: Our CR rates double the average of approved drugs, FDA considers 95% confidence intervals, and our high response rates allow a smaller pivotal trial.

Q: Plan for first line?

A: Continuing to recruit first-line patients for additional data, first line is the ultimate indication but focusing on second line for approval due to unmet need.