Delcath Systems, Inc.

Delcath sells a drug-and-device kit that temporarily isolates the liver's venous outflow, infuses high-dose melphalan into the hepatic artery, filters the exiting blood outside the body, and then returns it to circulation.

Ticker

DCTH

Company

Delcath Systems, Inc.

Exchange

Nasdaq

Listing

listed

Sector

Oncology / Drug-Device Combination

The bull case is that Delcath builds a durable, high-gross-margin drug-device business whose revenue grows with completed procedures at certified treatment centers, while success in randomized colorectal- and breast-cancer Phase 2 trials could create clinical-option value.S2S3S4S5S7S8

• Delcath is listed on Nasdaq under DCTH and reports to the U.S. SEC. It sells HEPZATO KIT in the United States and CHEMOSAT in Europe.S1S2
• HEPZATO combines melphalan with a hepatic delivery system. The procedure delivers melphalan into the hepatic artery, captures venous outflow from the liver, filters it outside the body and returns the blood to circulation; filtration reduces systemic exposure but does not eliminate it.S2S5
• The FDA approved HEPZATO on August 14, 2023 for adults with uveal melanoma and unresectable hepatic metastases affecting less than 50% of the liver, with either no extrahepatic disease or extrahepatic disease limited to bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.S4S5
• FDA orphan-drug exclusivity for that specific approved indication runs through August 14, 2030; it is not exclusivity for every liver tumor or future indication.S9
• FOCUS was an open-label, single-arm study. Among 91 efficacy-evaluable patients, independent review found a 36.3% objective response rate and a 14-month median duration of response. These results do not establish a randomized survival benefit.S4
• HEPZATO is administered every six to eight weeks for up to six infusions. In the 95-patient safety population, 68% had Grade 3 or 4 myelosuppression, including thrombocytopenia in 55%, anemia in 33% and neutropenia in 30%.S5
• Q1 2026 revenue was $24.994 million, including $23.247 million from HEPZATO and $1.747 million from CHEMOSAT. Gross margin was about 85%, net loss was $1.070 million and operating cash flow was positive $0.857 million; the cash-flow reconciliation included a $4.946 million non-cash stock-compensation addback.S2S3
• At March 31, 2026, Delcath held $41.313 million of cash and cash equivalents plus $47.986 million of short-term investments. As of May 7, 2026, management reported 29 active treatment centers and guided to at least $100 million of 2026 revenue, an 84% to 87% gross margin and positive adjusted EBITDA; those figures are guidance, not achieved full-year results.S2S3
• Q1 2026 research and development expense rose to $9.824 million from $5.007 million a year earlier, while non-GAAP adjusted EBITDA fell to $3.4 million from $7.6 million.S2S3
• The registered breast-cancer and colorectal-cancer programs are randomized Phase 2 trials, each with an estimated enrollment of 90 and a recruiting status as of the source check. Neither program is an approved indication or proven commercial revenue.S7S8

• narrativeTwenty-nine active centers are evidence of commercial infrastructure, not proof of treatment capacity, patient demand or durable utilization. The bull case still requires procedure volume per center to compound.
• narrativeThe bull case additionally requires the platform to demonstrate safety and efficacy in the randomized colorectal- and breast-cancer Phase 2 trials, followed by separate regulatory approvals and reimbursement. None of that is established today.
• narrativeAn 85% gross margin and positive quarterly operating cash flow make Delcath look more mature than a pre-revenue biotech, but Q1 adjusted EBITDA fell while research spending nearly doubled. One quarter does not prove a self-funding platform.

• ▸HEPZATO carries boxed warnings for severe peri-procedural complications and myelosuppression. It is restricted to certified facilities under a REMS, and patients must be monitored for severe peri-procedural complications during treatment and for at least 72 hours afterward. In the 95-patient FOCUS safety population, serious adverse reactions occurred in 45% and fatal adverse reactions occurred in three patients, or 3.2%.S4S5
• ▸HEPZATO generated about 93% of Q1 2026 product revenue, while its U.S. approval remains limited to one narrowly defined uveal-melanoma indication.S2S4
• ▸Two customers together represented approximately 26.5% of Q1 2026 product revenue, creating hospital-customer concentration risk.S2
• ▸The permanent product-specific J-code supports billing, but temporary outpatient drug pass-through status is scheduled to expire on March 31, 2027. Coverage, pre-authorization and reimbursement can still affect adoption.S6
• ▸Delcath disclosed an agreement with one melphalan supplier and depends on third parties for critical components; inventory and supplier discussions reduce but do not remove interruption risk.S6
• ▸The two Phase 2 expansion programs can fail, run late or never support label expansion. Estimated completion dates are planning assumptions, not guaranteed catalysts.S2S7S8
• ▸At March 31, 2026, 1.341 million pre-funded warrants were outstanding and already included in basic weighted shares. Separately, 11.359 million securities underlying preferred stock, options, restricted stock units and the employee purchase plan were excluded from diluted EPS because their effect was antidilutive; this gross count is not an estimate of incremental dilution under the treasury-stock method. The shelf permits up to $150 million of future securities offerings but is neither an announced equity offering nor existing dilution. On May 13, 2026, stockholders approved 1.8 million additional shares for the 2020 equity plan.S2S10
• ▸KIMMTRAK is FDA-approved for HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma. HEPZATO is differentiated as a liver-directed treatment without an HLA restriction in its label, but that distinction does not remove approved competition.S4S5S11

Uveal melanoma

— a rare cancer that starts in the eye; HEPZATO's U.S. label covers a defined group whose disease has spread to the liver

Hepatic metastases

— cancer deposits in the liver that originated elsewhere in the body

Percutaneous hepatic perfusion

— a catheter-based procedure that delivers chemotherapy to the liver while routing its venous outflow through an external filter

Melphalan

— a cytotoxic chemotherapy drug; HEPZATO uses a high liver-directed dose through the delivery system

REMS

— an FDA-mandated risk-management program that restricts where and by whom a drug can be administered

Objective response rate

— the share of evaluable patients whose tumors shrink by a predefined amount; it is not the same as overall survival

Pre-funded warrant

— a warrant with nearly all of the exercise price paid upfront, leaving only a nominal amount before conversion into a share