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Dec 31, 2021
Moleculin Q4 2021 Earnings Report
Moleculin reported its financial results for the year ended December 31, 2021, and provided an update on its portfolio of oncology drug candidates.
Key Takeaways
Moleculin Biotech reported a net loss of $15.9 million for the year ended December 31, 2021, which included non-cash gains of $6.7 million on warrants. The company ended the year with $70.9 million in cash, sufficient to fund operations into 2024.
Preliminary positive safety and efficacy data from the second Phase 1 AML study supports plans to explore a Phase 1/2 of Annamycin in combination with Cytarabine.
Preliminary interim data for Annamycin in three Phase 1 clinical trials for Acute Myeloid Leukemia (AML) and metastases of Soft Tissue Sarcoma (STS) continues to demonstrate the absence of cardiotoxicity.
WP1122 advancing with parallel development toward first-in-human Phase 1a study to evaluate safety and pharmacokinetics in healthy volunteers for the treatment of COVID-19 and potential treatment of glioblastoma multiforme (GBM).
The company has sufficient capital to fund operations into 2024.
Moleculin
Moleculin
Forward Guidance
Moleculin Biotech anticipates multiple key clinical and regulatory milestones throughout 2022, including commencing Phase 1/2 studies for Annamycin and WP1122, completing Phase 1b portion of Annamycin study, and ongoing preclinical development work.
Positive Outlook
- Initiate Phase 1/2 study in Europe for the treatment of AML evaluating combination therapy of Annamycin + Ara-C in H1 2022.
- 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.
- Commence Phase 1a study of WP1122 for the treatment of COVID-19 in the UK in H1 2022.
- Potential to launch Phase 2 pivotal study of WP1122 for the treatment of COVID-19 outside of the US in H1 2022.
Challenges Ahead
- The milestone expectations are forward-looking statements involving risks and uncertainties.
- Actual results may differ materially from expectations.
- The company's ability to meet milestones depends on various factors.
- Clinical trial outcomes are uncertain.
- Regulatory approvals are not guaranteed.