Moleculin Provides Update on Second Multiple Ascending Dose (MAD) Cohort in Phase 1a Clinical Trial of WP1122 in the UK

Company enters what it expects to be the final MAD cohort in the first-in-human Phase 1a designed to establish a maximum tolerated dose (MTD) HOUSTON, Oct. 14, 2022 — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today provided an update on the preliminary results from the second multiple ascending dose (MAD) cohort of the Company’s first-in-human Phase 1a study of WP1122. This cohort consisted of an initial 4 subjects, who were scheduled to be dosed daily for 7 days with 64 mg/kg/day of WP1122 or placebo in the dose escalation trial evaluating the safety and pharmacokinetics (PK) of WP1122 in healthy volunteers in the United Kingdom (UK). In conjunction with the study safety review committee, the Company stopped the second MAD cohort when 2 subjects experienced adverse events that, although asymptomatic, met the stoppage criteria in the protocol. The Company has opened MAD cohort 2a, in which a minimum of 8 subjects will receive a daily dose of 48 mg/kg. The Company expects this to be the final dose escalation cohort in this trial, which is designed to establish a maximum tolerated dose (MTD).

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