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Jun 30, 2022
Moleculin Q2 2022 Earnings Report
Reported financial results for the second quarter of 2022 and provided a programs update, highlighting clinical progress and compelling safety and efficacy data.
Key Takeaways
Moleculin Biotech reported its financial results for Q2 2022, noting progress across clinical and preclinical programs and sufficient capital to fund operations beyond mid-2024. The company highlighted clinical trial advancements for Annamycin and WP1122.
Announced the conclusion of Phase 1b portion of Annamycin clinical trial for STS lung mets and opened recruitment for Phase 2.
Received allowance to proceed with Phase 1/2 study of Annamycin in combination with Cytarabine for AML.
Commenced dosing in Phase 1a clinical trial evaluating WP1122 in healthy volunteers in the UK for COVID-19.
The company ended the quarter with $58.0 million of cash.
Moleculin
Moleculin
Forward Guidance
Moleculin Biotech anticipates several milestones in the near term, including commencing enrollment in a Phase 1/2 study of Annamycin for AML, reporting Phase 2 interim data for Annamycin in STS lung metastases, and topline data from a Phase 1a study of WP1122 for COVID-19.
Positive Outlook
- Q3 2022: Commence enrollment in Phase 1/2 study of Annamycin in combination with Ara-C in Acute Myeloid Leukemia.
- H2 2022: Commencement of an investigator-funded, second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases in Europe.
- H2 2022: Report Phase 2 interim data from ongoing Phase 1b/2 study of Annamycin for the treatment of sarcoma lung metastases in the US.
- H2 2022: Topline data from Phase 1a study of WP1122 for the treatment of COVID-19 in the UK.
- Potential to launch Phase 2 study of WP1122 for the treatment of COVID-19 outside of the US.
Challenges Ahead
- Volatility and unpredictability of COVID-19 incidence in various countries may limit the ability to recruit certain subjects and could make it infeasible to conduct a Phase 2 clinical trial.
- The ability of the US STS lung metastases clinical trial to continue the recruitment of subjects.
- The ability of the EU STS lung metastases trial to recruit subjects
- The ability of Annamycin to eventually be approved by the FDA and the European Medicines Agency.
- The ability of the WP1122 Phase 1 clinical trial to continue to recruit subjects and demonstrate safety and tolerability.