Loading...
•
Dec 31, 2022
Delcath Q4 2022 Earnings Report
Delcath Systems announced up to $85 million financing led by Vivo Capital.
Key Takeaways
Delcath Systems announced a private placement expected to provide up to $85 million in gross proceeds. The financing, led by Vivo Capital, includes an initial upfront funding of $25 million and is expected to fund the company through potential approval of HEPZATO and its commercialization.
Delcath Systems signed securities purchase agreements for up to $85 million in gross proceeds.
The financing is led by Vivo Capital with participation from other healthcare-focused institutional investors.
Initial upfront funding of $25 million is included in the private placement.
The financing is expected to fund the company through potential approval of HEPZATO and commercialization.
Delcath
Delcath
Forward Guidance
Delcath Systems expects the aggregate proceeds from the financing to fund commercialization of HEPZATO in the U.S. There are uncertainties relating to the likelihood and timing of the potential approval of HEPZATO by the FDA by the PDUFA date of August 14, 2023 and the Company’s ability to generate revenue from HEPZATO.
Positive Outlook
- Financing expected to be sufficient to fund Company through potential approval of HEPZATO and commercialization
- HEPZATO Kit was the subject of a February 14, 2023 new drug application resubmission to FDA for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM), also known as metastatic uveal melanoma (mUM).
- FDA has established an August 14, 2023 PDUFA date for the resubmission.
- In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT
Challenges Ahead
- Uncertainties relating to anticipated use of proceeds from the private placement
- Uncertainties relating to achievement of milestones
- Uncertainties relating to the likelihood and timing of the potential approval of HEPZATO by the FDA by the PDUFA date of August 14, 2023
- Uncertainties relating to the Company’s ability to commercialize HEPZATO
- Uncertainties relating to the receipt of stockholder approval to allow for the conversion of the Series F Preferred Stock into shares of the Company’s common stock and the exercisability of the warrants