On April 1, 2021 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the fourth quarter ended December 31, 2020, and earlier today reported preliminary topline data (Press release, Delcath Systems, APR 1, 2021, View Source [SID1234577495]). The company will host its quarterly call at 8:00am ET today, with a primary focus on discussing the preliminary top line data.

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Recent Business Highlights

During and since the fourth quarter of 2020, the company:

Reported positive preliminary results from the FOCUS Clinical Trial (NCT02678572) for Patients with Hepatic Dominant Ocular Melanoma treated with HEPZATO based on an analysis of currently evaluable patients. The preliminary analysis included 87% of treated patients and final results are expected later in the year. The primary endpoint, overall response rate (ORR), as determined by an independent review committee, exceeded the prespecified threshold for success. Additionally, both prespecified ORR and Progression Free Survival comparative analyses against the best alternative care arm demonstrated a statistically significant improvement. The safety profile was consistent with the safety profile of CHEMOSAT treatment described in previous European single-center and multi-center publications with no new safety signals observed in this patient population.

Initiated a consulting engagement to select a portfolio of follow-on indications which will maximize the value of the HEPZATO Kit and CHEMOSAT platform.

Completed an underwritten public offering of common stock at a price of $13.25 per share yielding $22.2 million in gross proceeds.

Strengthened the executive team with the appointment of Gerard Michel as Chief Executive Officer and Kevin Muir as Vice President of Commercial Operations.

"The fourth quarter marked the start of a critical transformation for Delcath," said Gerard Michel, CEO of Delcath. "Since October, we have attracted new investors, strengthened the management team and, most importantly, released preliminary results from the FOCUS trial which, as of this compilation, suggests a significant improvement in the benefit risk ratio versus an earlier generation of Delcath’s proprietary percutaneous hepatic perfusion system. We look forward to continued progress in 2021, as we prepare both to file an NDA in early 2022 and expand the development of HEPZATO into additional areas of high unmet need."

Fourth Quarter 2020 Financial Results:

Income Statement Highlights.

Product revenue for the three months ended December 31, 2020 was approximately $379 thousand, compared to $398 thousand for the prior year period from our sales of CHEMOSAT procedures in Europe. Selling, general and administrative expenses were approximately $4.5 million compared to $2.1 million in the prior year quarter. Research and development expenses for the quarter were $2.7 million compared to $2.7 million in the prior year quarter. Total operating expenses for the quarter were $7.3 million compared with $4.8 million in the prior year quarter.

We recorded a net loss for the three months ended December 31, 2020, of $7.0 million, compared to a net income of $12.5 million for the same period in 2019.

Balance Sheet Highlights.

At December 31, 2020, we had cash, cash equivalents and restricted cash totaling $28.8 million, as compared to cash, cash equivalents and restricted cash totaling $10.2 million at December 31, 2019. During the three months ended December 31, 2020 and December 31, 2019, we used $4.6 million and $5.4 million, respectively, of cash in our operating activities.

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