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Mar 31, 2021
Moleculin Q1 2021 Earnings Report
Reported financial results for the quarter ended March 31, 2021, and provided a program update.
Key Takeaways
Moleculin Biotech reported a net loss of $4.4 million for the first quarter of 2021, with research and development expenses increasing due to expanded clinical trial activity and manufacturing costs. The company's cash position was significantly strengthened, ending the quarter with approximately $86.3 million.
Granted Rare Pediatric Disease Designation (RPD) from the FDA to WP1066 for ependymoma.
Engaged IQVIA Biotech to manage potential clinical trials of WP1122 for COVID-19 treatment.
Received Fast Track Designation from the FDA for Annamycin for soft tissue sarcoma (STS) lung metastases.
Closed a public offering for gross proceeds of approximately $78.0 million, strengthening the financial position.
Moleculin
Moleculin
Forward Guidance
Moleculin anticipates several key clinical and regulatory milestones over the next 18 months, supported by a strengthened financial position that extends the cash runway through 2023. The company plans to advance its portfolio of drug candidates across multiple oncology indications and viruses, with the potential for up to seven clinical trials this year.
Positive Outlook
- Anticipated topline results from the ongoing Phase 1/2 study for Annamycin in AML in 2H 2021.
- Planned commencement of a Phase 1/2 study in Europe for Annamycin + Ara-C in AML in 2H 2021.
- Expected commencement of a Phase 1b/2 clinical trial of Annamycin for STS lung metastases in the U.S. in 2H 2021.
- Planned facilitation of a Phase 1/2 study of WP1066 + radiation for GBM in 2H 2021.
- Aimed launch of a Phase 2 study of WP1066 for pediatric brain tumors, including DIPG, in 1H 2022.
Challenges Ahead
- Uncertainty regarding the success of investigator-funded trials.
- Dependence on finding collaboration partners for WP1220 development.
- Risk that preclinical performance of WP1122 may not translate into improved clinical outcomes.
- Potential delays in initiating Phase 1a/1b study of WP1122 for COVID-19.
- Uncertainty regarding the ability to file an IND for WP1122 in antiviral indications by 2022.