Delcath : Failure to Satisfy Listing Rule Form 8 K
July 09, 2024 at 09:03 am EDT
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Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
On July 8, 2024, Delcath Systems, Inc. (the "Company") received a letter from The Nasdaq Stock Market LLC ("Nasdaq") informing the Company that it had regained compliance with the audit committee composition requirements as set forth in Nasdaq Listing Rule 5605 for continued listing on The Nasdaq Capital Market.
As previously disclosed, on May 29, 2024, the Company was notified by Nasdaq that it was not in compliance with Nasdaq Listing Rule 5605 because its Audit Committee was not comprised of at least three "independent directors" (as defined in Nasdaq Listing Rule 5605(a)(2)). The Company was given until the Company's next annual meeting of stockholders or May 23, 2025 to regain compliance.
To regain compliance, the Company was required to identify and select a member of the board of directors of the Company (the "Board") who qualifies as "independent" and would meet the audit committee criteria set forth in Nasdaq Listing Rule 5605. This requirement was met on July 2, 2024, when the Board appointed Dr. Bridget Martell as a member of the Audit Committee of the Board.
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Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company's products, HEPZATO KIT (Hepzato (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System for Melphalan (CHEMOSAT) percutaneous hepatic perfusion (PHP) are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. HEPZATO KIT is a drug/device combination product designed to administer high-dose chemotherapy directly into the liver while limiting systemic exposure and associated side effects. In Europe, the hepatic delivery system is a stand-alone medical device having the same device components as HEPZATO KIT, but without the melphalan hydrochloride and is approved for sale under the trade name CHEMOSAT. In the United States, HEPZATO is regulated as a drug by the United States Food and Drug Administration (FDA).
DELCATH SYSTEMS, INC. 
