Loading...
•
Sep 30, 2022
Moleculin Q3 2022 Earnings Report
Reported financial results for the third quarter of 2022 and provided a pipeline update.
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.
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.
Historical Earnings Impact
Analyze how earnings announcements historically affect stock price performance
Avg. Return Before/After Earnings
Loading earnings performance data...
Loading earnings reaction data...