On August 8, 2022 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 second quarter ended June 30, 2022 (Press release, Delcath Systems, AUG 8, 2022, View Source [SID1234617798]).
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Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. (PRNewsfoto/Delcath Systems, Inc.)
Recent Business Highlights
During and since the second quarter, Delcath:
Held a pre-NDA meeting with FDA and locked the phase 3 FOCUS Trial database for the purpose of resubmitting the NDA for the Hepzato Kit (melphalan hydrochloride for injection/hepatic delivery system) in the third quarter of 2022,
Presented a poster updating the results from the FOCUS Trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting,
Opened two Expanded Access Program (NCT05022901) sites, and
Raised $5 million in a private placement priced at market.
In addition, during and since the fourth quarter, independent investigators:
Published Predictive Parameters in Patients Undergoing Percutaneous Hepatic Perfusion with Melphalan for Unresectable Liver Metastases from Uveal Melanoma: A Retrospective Pooled Analysis in the journal Cardiovascular and Interventional Radiology,
Presented two abstracts on the use of Chemosat Hepatic Delivery System with Melphalan in the treatment of metastatic uveal melanoma at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, including:
Safety and efficacy of combined melphalan percutaneous hepatic perfusion (M-PHP) and ipilimumab plus nivolumab (IPI+NIVO) in metastasized uveal melanoma: First results of the phase Ib part of the CHOPIN trial, and
Temporal evolution in quality-of-life following melphalan percutaneous hepatic perfusion for patients with metastatic uveal melanoma.
"As we prepare to resubmit the Hepzato Kit NDA by the end of the third quarter, Chemosat usage in Europe continues to result in publications supportive of both Chemosat and by extension the Hepzato Kit," said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel continued, "We would expect that within 30 days of the resubmission, the FDA will confirm receipt of the submission and, if they agree the resubmission is sufficiently complete to warrant review, establish a PDUFA date sometime late in the first quarter of 2023."
First Quarter 2022 Results
Income Statement Highlights.
Total revenue for the three months ended June 30, 2022, was approximately $0.8 million, compared to $0.5 million for the prior year period, from our sales of CHEMOSAT in Europe. This increase in product revenue is primarily due to a full quarter of direct product sales by Delcath compared to the revenue share arrangement with our distribution partner in Europe in 2021.
Research and development expenses for the quarter were $5.5 million, compared to $3.5 million in the prior year quarter. The growth in R&D expense is primarily due to increased activity related to the NDA preparation. Selling, general and administrative expenses for the quarter were approximately $4.1 million, compared to $3.3 million in the prior year quarter. Total operating expenses for the quarter were $9.6 million, compared with $6.8 million in the prior year quarter.
The Company recorded a net loss for the three months ended June 30, 2022, of $9.7 million, compared to a net loss of $6.4 million for the same period in 2021.
Balance Sheet Highlights
On June 30, 2022, the Company had cash, cash equivalents and restricted cash totaling $14.4 million, as compared to cash, cash equivalents and restricted cash totaling $27.0 million on December 31, 2021. During the three months ended June 30, 2022, and June 30, 2021, we used $6.1 million and $7.1 million, respectively, of cash in our operating activities.
On July 20, 2022, Delcath closed a private placement for the issuance and sale of 690,954 shares of common stock (the "Common Stock") and 566,751 pre-funded warrants to purchase Common Stock (the "Pre-Funded Warrants") to certain investors. Each share of Common Stock was sold at a price per share of $3.98 and the Pre-Funded Warrants were sold at a price of $3.97 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.01 per share of Common Stock and are immediately exercisable. Delcath received gross proceeds from the Private Placement of approximately $5.0 million before deducting offering expenses payable by Delcath. Delcath intends to use the net proceeds from the Private Placement for working capital purposes and other general corporate purposes.