Moleculin Q3 2022 Earnings Report
Key Takeaways
Moleculin Biotech reported progress across its pipeline, with three active Phase 1/2 clinical trials for Annamycin showing no evidence of cardiotoxicity. The company believes it has sufficient capital to fund operations beyond mid-2024.
Opened enrollment in the Phase 1/2 Study of Annamycin in combination with cytarabine for the treatment of Acute Myeloid Leukemia (“AML”) in Europe.
Initiated and began dosing in the Phase 2 portion of the U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases ("STS lung mets").
Continued expanding the safety profile of Annamycin with a third report from an independent cardiology expert assessing recent subjects, which confirmed that there was no evidence of cardiotoxicity associated with Annamycin.
Concluded Phase 1a first-in-human clinical trial of WP1122 for the treatment of COVID-19 in the United Kingdom establishing a safe and tolerable dose in healthy volunteers.
Moleculin
Moleculin
Forward Guidance
Moleculin anticipates several milestones in the coming quarters, including commencing dosing in the Phase 1/2 study of Annamycin in combination with Ara-C in Acute Myeloid Leukemia, reporting Phase 2 interim data from the Phase 1b/2 study of Annamycin for the treatment of STS lung mets, commencement of investigator-sponsored clinical trials or programs for the treatment of adult and pediatric brain tumors, identifying investigators interested in initiating a Phase 1 study of oral WP1122 in adult patients with GBM, and reporting preliminary findings of NIH-funded animal testing of WP1096 in the Tacaribe Arenavirus.
Positive Outlook
- Commence dosing and open additional clinical sites in Poland and other European countries in the Phase 1/2 study of Annamycin in combination with Ara-C in Acute Myeloid Leukemia (Q4 2022).
- Report Phase 2 interim data from ongoing Phase 1b/2 study of Annamycin for the treatment of STS lung mets in the US and Europe (Q1 2023).
- Commencement of investigator-sponsored clinical trials or programs for the treatment of adult and pediatric brain tumors (H1 2023).
- Identify investigators interested in initiating a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.
- Report preliminary findings of NIH-funded animal testing of WP1096 in the Tacaribe Arenavirus by the end of the first quarter 2023.