Moleculin Q2 2021 Earnings Report
Key Takeaways
Moleculin Biotech reported its financial results for the quarter ended June 30, 2021. Noteworthy progress was made in the clinical development program for Annamycin. The company believes the next 18 months hold key inflection points and value drivers.
Received approval to extend dose escalation in Phase 1/2 European clinical trial evaluating Annamycin for the treatment of acute myeloid leukemia (AML).
Commenced enrollment and dosed the first subject in its U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases.
H2 2021: Seek to initiate Phase 1a/1b study of WP1122 for the treatment of COVID-19 in the UK.
The Company ended the quarter with approximately $79.5 million of cash.
Moleculin
Moleculin
Forward Guidance
Moleculin anticipates several milestones in the near future.
Positive Outlook
- H2 2021: Report cohort topline results from the ongoing Phase 1/2 study for treatment of AML and report the study's topline results.
- H2 2021: Commence Phase 1/2 study in Europe for the treatment of AML evaluating combination therapy of Annamycin + AraC.
- H2 2021: Commencement of an investigator-funded, second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases in Europe
- H1 2022: Facilitate launch of physician-sponsored Phase 2 study of WP1066 for the treatment of pediatric brain tumors including DIPG.
- Seek to initiate Phase 1a/1b study of WP1122 for the treatment of COVID-19 in the UK.
Challenges Ahead
- Actively seek collaboration with a strategic partner in the near term for external funding for the continued development of WP1220 in a Phase 2 clinical trial as a topical therapy for CTCL.
- Potential to launch Phase 2 pivotal study of WP1122 for the treatment of COVID-19 outside the U.S.
- File an IND in the U.S. for the treatment of certain cancers such as GBM and pancreatic cancer, with WP1122.
- Ongoing preclinical development work in anti-viral indications such as HIV, Zika, and Dengue. IND targeted for 2022.
- The Company believes that this cash is sufficient to meet its projected operating requirements, which include a forecasted increase over its current R&D rate of expenditures, into 2024.