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Jun 30, 2020
Delcath Q2 2020 Earnings Report
Delcath reported a net loss of $4.3 million and product revenue of $262 thousand.
Key Takeaways
Delcath Systems, Inc. announced financial results for the quarter ended June 30, 2020. The company completed a $22 million public offering and uplisted to the NASDAQ Capital Market. Product revenue was $262 thousand, and the net loss was $4.3 million.
Completed a $22 million public offering to fund the Phase 3 registration trial of Melphalan/HDS in liver-dominant metastatic ocular melanoma (mOM) and refiling of an NDA with the FDA.
Uplisted to the NASDAQ Capital Market.
Initiated pre-commercialization work for Melphalan/HDS in mOM.
Management is focused on delivering top-line results for the Phase 3 FOCUS trial by year-end 2020/early 2021.
Forward Guidance
Delcath expects top-line results from the Phase 3 FOCUS trial by year-end 2020/early 2021 and plans to submit a New Drug Application (NDA) by mid-2021. They also intend to initiate additional clinical studies for Melphalan/HDS in liver-dominant orphan cancers.
Positive Outlook
- Completion of Phase 3 FOCUS trial in metastatic ocular melanoma by year-end 2020/early 2021.
- Potential FDA approval in the second half of 2021 for Melphalan/HDS as a treatment for mOM patients.
- Initiation of additional studies in one or more liver-dominant metastatic indications.
- Sufficient cash runway through multiple value inflection points.
- The company expects to initiate at least one additional clinical development program of Melphalan/HDS in coming quarters.
Challenges Ahead
- Covid-19 has affected clinical trials, including the Phase 3 FOCUS registration trial.
- Restrictions to clinical sites for data entry and monitoring during the quarter.
- Net loss of $4.3 million for the quarter ended June 30, 2020.
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