Moleculin Biotech, Inc. Q2 FY2023 earnings call

• Reiterated 2023 as the year of data, with data from priority pipeline programs coming into view. Completed Phase 1B of the MB-106 AML trial, established Phase 2 dose for AML and commenced Phase 2 recruitment, with a preliminary 33% CR rate in AML Phase 1B. In STS, 73% of subjects showed stable disease after two cycles. - Progress on Immune/Transcription Modulator: Work on IV formulation of 1066 drug, discussions with academic institutions for brain tumor trials. - 1122 glycosylation inhibitor: Opened IND for Phase 1 study in glioblastomas, granted orphan drug designation. - Cash position: $32 million cash on hand at end of Q2, expected to last into Q3 2024, with planned funded activities including current trials and preparations for future trials.

The company has several product segments. For the Annamycin program: In AML, the Phase 1B portion of the MB-106 trial was completed, establishing the Phase 2 dose and commencing Phase 2 recruitment, with a preliminary complete response rate of 33% in the Phase 1B portion. In soft tissue sarcoma (STS), 73% of subjects exhibited stable disease after two cycles of treatment. For the Immune/Transcription Modulator, progress is being made on creating an intravenous formulation of the 1066 drug, with discussions with academic institutions for pediatric brain tumor trials. For the 1122 glycosylation inhibitor, an IND has been opened to initiate a Phase 1 study for glioblastomas, and orphan drug designation from the FDA has been granted for glioblastoma-type brain tumors.

• Expect to announce Phase 2 data for AML and more Phase 2 data for STS in quarterly and year-end calls. - Anticipate presenting the study report from prior MB-105 monotherapy with Annamycin in AML study and updates on the ongoing 106 study. - Progress on IV formulation of 1066 and discussions with academic institutions for brain tumor trials continue.

• Data from clinical trials are preliminary and subject to change. - Monitoring for cardiac toxicity in patients treated with Annamycin, but no evidence of heart damage so far. - Uncertainty in timing of regulatory dialogues with authorities.

Q: Is this R&D run rate real or is this kind of temporarily low like last year?

A: It should be low this quarter and gradually increasing as we move into the fourth quarter and the first quarter of next year as we prepare for future clinical trials, with another batch of Annamycin being produced, and the $32 million cash on hand taking us into the third quarter of next year.

Q: Is there a plan to present at a conference or is this just going to be at the typical quarterly updates?

A: Our reference was focused on quarterly updates, but we are expecting to have presentations at upcoming ASH and other critical meetings, with data being interesting for those conferences and folks presenting. You can count on thorough clinical updates in quarterly calls.

Q: In terms of the MB-107 STS lung mets study, were there any PRs or CRs or do you anticipate sharing waterfall or swimmer plots?

A: Data are preliminary as at the recommended Phase 2 dose, many patients are ongoing and haven't had progressive disease yet. We have not seen a patient with better than stable disease, but considering it's fourth-line therapy, 67% to 73% with stable disease at initial evaluation is pleasing given the patient population.