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Sep 30, 2021
Moleculin Q3 2021 Earnings Report
Reported financial results for the quarter ended September 30, 2021.
Key Takeaways
Moleculin Biotech reported its financial results for the quarter ended September 30, 2021. The company's research and development expense was $4.1 million. They ended the quarter with $75.2 million of cash and believe that this cash is sufficient to meet its projected operating requirements into 2024.
Up to six clinical trials expected to be underway or with regulatory clearance by the end of 2021
Preliminary clinical activity for Annamycin seen in interim results from its US Phase 1b/2 clinical trial for the treatment of soft tissue sarcoma (STS) lung metastases
Received favorable opinion from the MHRA to commence first-in-human Phase 1a study to evaluate safety and pharmacokinetics of WP1122 in healthy volunteers for the treatment of COVID-19, expected to commence in Q4 2021
STS lung metastases trial continues to recruit rapidly
Moleculin
Moleculin
Forward Guidance
Moleculin anticipates several milestones in the upcoming months, including reporting topline results from ongoing studies and initiating new clinical trials.
Positive Outlook
- Report cohort topline results from the ongoing Phase 1/2 study for treatment of AML and report the study's topline results in H2 2021
- Report cohort topline results from the ongoing Phase 1/2 study for treatment of STS lung metastases and report the study's topline results in H2 2021
- Initiate Phase 1/2 study in Europe for the treatment of AML evaluating combination therapy of Annamycin + Ara-C in H2 2021
- Commencement of an investigator-funded, second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases in Europe in H1 2022
- Complete Phase 1b portion of ongoing Phase 1b/2 study of Annamycin for the treatment of sarcoma lung metastases in the US in H1 2022
Challenges Ahead
- Filing a US Investigational New Drug application (IND) for the treatment of certain adult cancer(s) with WP1066 and begin to identify an institution to commence an associated investigator-funded Phase 1a/1b study in H2 2021
- Report topline results from Phase 1 physician-sponsored pediatric brain tumor clinical trial in H1 2022
- Facilitate launch of physician-sponsored Phase 2 study of WP1066 for the treatment of pediatric brain tumors including DIPG in H2 2022
- 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
- Commence Phase 1a study of WP1122 for the treatment of COVID-19 in the UK in H2 2021