Delcath Systems Provides Business Update and Reports Preliminary First Quarter 2023 Financial Results

Strategic Insights -

Delcath Systems, Inc., an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, has announced business highlights and certain preliminary financial results for the first quarter ended March 31, 2023. The company has appointed John R. Sylvester as Chairman of the Board, and Gerard Michel, Chief Executive Officer, expressed optimism about the company's future prospects, citing a critical financing behind them. As of March 31, 2023, Delcath had cash, cash equivalents, and restricted cash totaling $24.3 million, a significant increase from $11.8 million at the same time last year.

Key Takeaways:

  • Revenue for the three months ended March 31, 2023, is expected to be approximately $0.6 million, a 50% increase from $0.4 million in the same period last year.
  • Research and development expenses are expected to remain relatively flat at approximately $4.5 million for the three months ended March 31, 2023, compared to the same period last year.
  • Delcath's full first quarter 2023 financial results will be reflected in a Quarterly Report on Form 10-Q, which is expected to be filed no later than May 22, 2023.
  • The company has appointed John R. Sylvester as Chairman of the Board and continues to prepare for the commercialization of Hepzato if approved.
  • Delcath has expanded the list of institutions that have indicated interest in becoming a treating center upon approval of Hepzato.
  • Gerard Michel, Chief Executive Officer, emphasized the company's focus on preparing to commercialize Hepzato if approved and the potential for expanding the list of institutions interested in becoming treating centers.

Statistics:

  • $24.3 million: estimated cash, cash equivalents, and restricted cash as of March 31, 2023.
  • 50%: increase in revenue from $0.4 million to $0.6 million for the three months ended March 31, 2023, compared to the same period last year.
  • $4.5 million: estimated research and development expenses for the three months ended March 31, 2023, compared to the same period last year.
  • August 14, 2023: PDUFA date for the resubmission of Hepzato Kit to the FDA.
  • May 22, 2023: expected date for the filing of Delcath's Quarterly Report on Form 10-Q for the quarter ended March 31, 2023.

Sources:

  • Delcath Systems, Inc. press release dated May 12, 2023.
  • Form 8-K filing with the Securities and Exchange Commission (SEC) dated May 12, 2023.
  • Delcath Systems, Inc. Annual Report on Form 10-K for the year ended December 31, 2022.