DCTH

Interested in Delcath Systems, Inc.? Here are five stocks we like better. Revenue and outlook improved: Second-quarter revenue rose 20% year over year to $29.1 million, driven by a 30% increase in HEPZATO KIT volume. Delcath raised its 2026 revenue guidance to $104 million–$108 million and expects positive adjusted EBITDA. Commercial expansion continued: Delcath ended the quarter with 31 active treatment centers and remains on track to reach approximately 37 by year-end. New patient starts and backup REMS-certified teams are intended to support capacity and treatment volume. Pipeline development is advancing but faces enrollment challenges: Phase II trials in metastatic colorectal and HER2-negative breast cancer are underway, while the company evaluates additional indications. Delcath said enrollment has been slower than expected because of coordination and training requirements at treatment centers. Delcath Systems (NASDAQ:DCTH) reported second-quarter 2026 revenue of $29.1 million, up from $24.2 million a year earlier, as growth in HEPZATO KIT sales supported continued commercial expansion and investment in clinical programs beyond metastatic uveal melanoma. HEPZATO KIT revenue totaled $27.1 million, which Chief Executive Officer Gerard Michel said was 21% higher than the comparable 2025 period despite the introduction of 340B pricing in July 2025. Chief Financial Officer Sandra Pennell said HEPZATO volume increased 17% sequentially from the first quarter and 30% year over year. → 3 Drone Stocks That Should Soar After the Summer Slump The company reported net income of $2.7 million, unchanged from the prior-year quarter. Adjusted EBITDA was $7.6 million, compared with $9.8 million in the second quarter of 2025. Delcath ended the quarter with $95.9 million in cash and investments and generated $5.7 million in operating cash flow. Delcath increased its full-year 2026 revenue guidance to a range of $104 million to $108 million. Pennell said the updated outlook reflects first-half performance, particularly the pace of new patient starts, as well as a more modest assumed seasonal decline in the second half. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth The forecast implies at least 28% growth in HEPZATO KIT volume from 2025, according to the company. Delcath also expects full-year gross margin of 86% to 89% and positive adjusted EBITDA. Second-quarter gross margin was 90%, compared with 86% a year earlier. Pennell attributed the improvement to better overhead absorption, favorable manufacturing performance and higher HEPZATO volume. She said the company remains conservative on the full-year margin outlook because of potential additional manufacturing costs. → Jersey Mike's Serves Fresh Gains After IPO Stumble Pennell said the difference between HEPZATO’s 30% volume growth and 21% revenue growth was entirely attributable to 340B pricing. She said the program reduced the company’s effective average selling price from roughly $185,000 per kit to approximately $170,000 to $173,000 per kit. Delcath activated two new treatment centers during the quarter, bringing its active network to 31 centers. The company remains on track to add approximately six additional centers by year-end, targeting 37 active centers. Michel said the company is prioritizing institutions with academic influence and referral reach, particularly National Comprehensive Cancer Network member institutions and National Cancer Institute-designated comprehensive cancer centers. About 80% of Delcath’s active treatment centers have NCI comprehensive designation, while the company is represented at 41% of the 58 NCI comprehensive cancer centers and about half of the 34 NCCN member institutions, he said. Centers added this year include MD Anderson, UT Southwestern, Mayo Clinic Scottsdale, Oregon Health & Science University’s Knight Cancer Institute and Columbia University’s Herbert Irving Comprehensive Cancer Center, according to Michel. New patient starts averaged approximately 0.5 per site per month during the second quarter. Michel said patients may receive a series of HEPZATO treatments over as many as three quarters, meaning second-quarter starts can contribute treatment volume through the second half of the year. In response to seasonal capacity constraints, Delcath has worked with treatment centers to train backup REMS-certified teams. Pennell said staff absences at centers with only one certified team had reduced capacity in the prior year. Michel said a meaningful percentage of company volume is now covered by centers with backup teams, including some higher-volume sites. Michel also described the company’s referral strategy as a combination of established networks within current institutions and “just-in-time” outreach to physicians who may encounter only one eligible patient. Delcath uses claims data to identify recently diagnosed patients and is evaluating other data sources that could be refreshed more frequently, he said. Delcath continues to pursue applications for its liver-directed platform in other liver-dominant cancers. Michel highlighted a retrospective analysis presented at ESMO Breast Cancer in May involving 15 heavily pretreated patients with liver-dominant metastatic breast cancer treated with percutaneous hepatic perfusion. Nine of the 15 patients experienced a hepatic partial response, he said. The company’s sponsored Phase II metastatic colorectal cancer trial now has 13 centers actively screening patients. Delcath estimates that roughly 6,000 to 10,000 U.S. patients annually have liver-dominant disease in the third-line colorectal setting. Michel said the company expects an interim colorectal readout sometime late in 2027. In HER2-negative metastatic breast cancer, Delcath recently dosed its first patient at the European Institute of Oncology in Milan. Six sites are activated and screening, with additional sites moving through activation. The company estimates an addressable population of similar size to the colorectal opportunity. Michel acknowledged that enrollment in both trials has been below the company’s initial expectations. He said the company underestimated the training and coordination required between interventional radiology teams and oncology clinical-trial teams, particularly at centers less familiar with the procedure. Delcath has added sites, provided specialized training and streamlined onboarding to address those issues. Separately, Michel said data from the randomized Phase II CHOPIN study, published earlier this year in The Lancet Oncology, has contributed to broader use of combination approaches at leading centers. At ASCO, investigators from Moffitt Cancer Center presented a trials-in-progress abstract for a Phase II study of HEPZATO followed by tebentafusp in HLA-A2-positive metastatic uveal melanoma patients. Delcath is also preparing for pre-IND meetings with the Food and Drug Administration later this year to discuss potential additional indications, Michel said. Delcath Systems, Inc is a specialty pharmaceutical and medical technology company focused on the development and commercialization of its proprietary Hepatic CHEMOSAT® Delivery System, designed to deliver high-dose chemotherapeutic agents directly to the liver while minimizing systemic exposure. The company's core technology performs isolated hepatic perfusion, enabling oncologists to administer concentrated melphalan to patients with primary and metastatic liver tumors, including those arising from ocular melanoma. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Delcath Systems Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Delcath Systems, Inc. (DCTH) came out with quarterly earnings of $0.07 per share, beating the Zacks Consensus Estimate of a loss of $0.16 per share. This compares to earnings of $0.07 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +143.75%. A quarter ago, it was expected that this company would post a loss of $0.01 per share when it actually produced a loss of $0.03, delivering a surprise of -200%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Delcath Systems, which belongs to the Zacks Medical - Instruments industry, posted revenues of $29.13 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 15.88%. This compares to year-ago revenues of $24.16 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Delcath Systems shares have added about 25.1% since the beginning of the year versus the S&P 500's gain of 12.8%. While Delcath Systems has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Delcath Systems was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.29 on $25.75 million in revenues for the coming quarter and -$0.88 on $103.46 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Instruments is currently in the bottom 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. 908 Devices Inc. (MASS), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 11. This company is expected to post quarterly loss of $0.14 per share in its upcoming report, which represents a year-over-year change of +22.2%. The consensus EPS estimate for the quarter has been revised 12.5% lower over the last 30 days to the current level. 908 Devices Inc.'s revenues are expected to be $15.18 million, up 16.5% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Delcath Systems, Inc. (DCTH) : Free Stock Analysis Report 908 Devices Inc. (MASS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Increases 2026 Revenue Guidance to a Range of $104M to $108MConference Call Today at 8:30 a.m. Eastern Time QUEENSBURY, N.Y., August 06, 2026--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced financial results and business highlights for the second quarter ended June 30, 2026. Second Quarter 2026 Financial Results Total revenue of $29.1 million, compared with $24.2 million in the second quarter of 2025 Gross margins of 90%, compared to 86% in the second quarter of 2025 Net income of $2.7 million for both second quarters in 2026 and 2025 Non-GAAP adjusted EBITDA of $7.6 million, compared to $9.8 million in the second quarter of 2025 Cash provided by operations of $5.7 million in the quarter; compared to $7.3 million in the second quarter of 2025 Cash and investments of $95.9 million as of June 30, 2026 Business Highlights Currently 31 active treatment centers Approximately 30% growth in HEPZATO volume in the second quarter 2026 compared to the second quarter 2025 Independent investigators presented retrospective data at ESMO Breast Cancer 2026 showing a 60% hepatic partial response rate with percutaneous hepatic perfusion in heavily pretreated patients with liver-dominant metastatic breast cancer Independent investigators presented two investigator-initiated Trials-in-Progress abstracts at ASCO 2026: one evaluating sequential HEPZATO followed by tebentafusp in metastatic uveal melanoma, and one evaluating HEPZATO in combination with nivolumab/relatlimab in metastatic cutaneous melanoma with liver metastases Dosed the first patient in the global Phase 2 trial of HEPZATO in combination with standard of care in patients with liver-dominant HER2-negative metastatic breast cancer "Our strong second quarter, including total revenue of $29.1 million and quarterly operating cash flow of $5.7 million, reflects continued momentum in HEPZATO procedures," said Gerard Michel, Chief Executive Officer of Delcath Systems. "As we grow our active treatment center network and drive physician adoption, we are seeing increased usage of HEPZATO in combination with systemic therapies to treat metastatic uveal melanoma. The growing clinical experience with this treatment strategy is strengthening physician confidence in HEPZATO and supporting its development as a multi-indication, liver-directed therapy platform, including colorectal and breast cancer." 2026 Full Year Financial Guidance The Company’s financial outlook for fiscal year 2026: Total HEPZATO KIT and CHEMOSAT revenue to range from $104 million to $108 million, reflecting an increase in HEPZATO KIT volume of at least 28% over 2025 Full year gross margins in the range of 86% to 89% Positive adjusted EBITDA Second Quarter 2026 Results Total revenue for the quarter ending June 30, 2026 was $29.1 million compared to $24.2 million for the same period in the prior year. Revenue in the quarter includes sales of $27.1 million of HEPZATO in the U.S. and $2.0 million of CHEMOSAT in Europe. Research and development expenses for the quarter ending June 30, 2026, were $10.4 million compared to $6.9 million for the same period in the prior year. The increase is primarily due to increased clinical headcount and increased clinical trial activity. Selling, general and administrative expenses for the quarter ended June 30, 2026, were $13.4 million compared to $11.4 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities. Net income was $2.7 million for both the quarters ended June 30, 2026 and June 30, 2025. Non-GAAP adjusted EBITDA for the quarter ended June 30, 2026 was $7.6 million compared to adjusted EBITDA of $9.8 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference. As of June 30, 2026, the Company had $95.9 million in cash and investments, and no debt. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Thursday, August 6, 2026Time: 8:30 AM Eastern Time Participant Numbers:Toll Free: 1-800-717-1738International: 1-646-307-1865Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1767384&tp_key=cbc23b55c8 A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website https://investors.delcath.com/news-events/events-and-presentations. GAAP v. Non-GAAP MeasuresDelcath’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. Delcath has provided in this release certain financial information that has not been prepared in accordance with GAAP. Delcath’s management believes that the non-GAAP adjusted EBITDA described in this release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding Delcath’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in Delcath’s industry. However, the non-GAAP financial measures that Delcath uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP. About Delcath Systems, Inc., HEPZATO KIT and CHEMOSATDelcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System (HDS) for Melphalan 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. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath’s proprietary HDS. The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Safe Harbor / Forward-Looking StatementsThe Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, including the Company’s statements regarding the possible synergy seen in the successful Phase 2 CHOPIN Trial being transferable to clinical practice; Company’s 2026 financial outlook, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company’s commercialization plans and its ability to successfully commercialize the HEPZATO KIT; contributions to adjusted EBITDA; the Company’s successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company’s successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company’s ability to obtain reimbursement for the HEPZATO KIT; and the Company’s ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company’s filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806634736/en/ Contacts Investor Relations Contact: ICR [email protected]

Orthofix (OFIX) came out with quarterly earnings of $0.07 per share, beating the Zacks Consensus Estimate of a loss of $0.03 per share. This compares to earnings of $0.13 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +333.33%. A quarter ago, it was expected that this medical device maker would post a loss of $0.29 per share when it actually produced a loss of $0.12, delivering a surprise of +58.62%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Orthofix, which belongs to the Zacks Medical - Instruments industry, posted revenues of $210.9 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 0.67%. This compares to year-ago revenues of $203.12 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Orthofix shares have lost about 19.5% since the beginning of the year versus the S&P 500's gain of 13%. While Orthofix has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Orthofix was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.08 on $211.47 million in revenues for the coming quarter and $0.27 on $842.98 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Instruments is currently in the bottom 35% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Delcath Systems, Inc. (DCTH), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This company is expected to post quarterly loss of $0.16 per share in its upcoming report, which represents a year-over-year change of -328.6%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Delcath Systems, Inc.'s revenues are expected to be $25.14 million, up 4.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ORTHOFIX MEDICAL INC. (OFIX) : Free Stock Analysis Report Delcath Systems, Inc. (DCTH) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Idexx Laboratories (IDXX) came out with quarterly earnings of $4.27 per share, beating the Zacks Consensus Estimate of $3.95 per share. This compares to earnings of $3.63 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +8.10%. A quarter ago, it was expected that this Animal diagnostic and health care company would post earnings of $3.42 per share when it actually produced earnings of $3.47, delivering a surprise of +1.46%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Idexx, which belongs to the Zacks Medical - Instruments industry, posted revenues of $1.22 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 1.28%. This compares to year-ago revenues of $1.11 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Idexx shares have lost about 16.1% since the beginning of the year versus the S&P 500's gain of 11%. While Idexx has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Idexx was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $3.79 on $1.19 billion in revenues for the coming quarter and $14.68 on $4.72 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Instruments is currently in the bottom 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Delcath Systems, Inc. (DCTH), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This company is expected to post quarterly loss of $0.16 per share in its upcoming report, which represents a year-over-year change of -328.6%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Delcath Systems, Inc.'s revenues are expected to be $25.14 million, up 4.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report IDEXX Laboratories, Inc. (IDXX) : Free Stock Analysis Report Delcath Systems, Inc. (DCTH) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

QUEENSBURY, N.Y., July 23, 2026--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on August 6, 2026, at 8:30 AM Eastern Time to discuss results for its second quarter ended June 30, 2026. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Thursday, August 6, 2026Time: 8:30 AM Eastern Time Participant Numbers:Toll Free: 1-800-717-1738International: 1-646-307-1865Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1767384&tp_key=cbc23b55c8 A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website here. About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (Hepzato (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan 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. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to surgically isolate the liver while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. View source version on businesswire.com: https://www.businesswire.com/news/home/20260723206368/en/ Contacts Investor Relations Contact: ICR [email protected]

Image source: The Motley Fool. Thursday, May 7, 2026 at 8:30 a.m. ET Chief Executive Officer — Gerard Michel Chief Financial Officer — Sandra Pennell Chief Commercial Officer — Kevin Muir Chief Medical Officer — Vojislav Vukovic Chief Operating Officer — Martha Rook Need a quote from a Motley Fool analyst? Email [email protected] David Hoffman: Thank you, and welcome to Delcath Systems First Quarter 2026 Earnings Call. With me on the call are Gerard Michel, Chief Executive Officer; Sandra Pennell, Chief Financial Officer; Kevin Muir, Chief Commercial Officer; Vojislav Vukovic, Chief Medical Officer; and Martha Rook, Chief Operating Officer. This statement is made pursuant to the safe harbor for forward-looking statements described in the Private Securities Litigation Reform Act of 1995. All statements made on this call, with the exception of historical facts, may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Although the company believes that expectations and assumptions reflected in these forward-looking statements are reasonable, it makes no assurance that such expectations will prove to have been correct. Actual results may differ in a material manner from those expressed or implied in forward-looking statements due to various risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those expressed or implied in the forward-looking statements, please see risk factors detailed in the company's annual report on Form 10-K, those contained in filed quarterly reports on Form 10-Q as well as in other reports that the company files from time to time with the Securities and Exchange Commission. Any forward-looking statements included in this call are made only as of the date of this call. We do not undertake any obligation to update or supplement any forward-looking statements to reflect subsequent knowledge, events or circumstances. Our press release with our first quarter 2026 results is available on our website under the Investors section and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website. Now I would like to turn the call over to Gerard. Gerard, please proceed. Gerard Michel: Thank you, David, and welcome, everyone. We've had a very successful first quarter marked by 4-centre activations and record new patient starts in the first quarter, both of which are core growth drivers for the business. In addition, we continue to advance numerous commercial and medical initiatives to ensure the long-term growth of HEPZATO with a strong focus on a third critical growth driver, building referral networks to quickly connect eligible patients with treating centers. To support center activations, increased utilization at existing centers and expanded referral patterns, we have nearly completed our U.S. commercial expansion into 9 regions. In addition, the expanded MSL team is fully trained and in the field, educating physicians about metastatic uveal melanoma with a focus on the CHOPIN results. As of today, we have 29 REMS-certified sites, and we are in active discussions with over 50 potential new centers. And 38 of these centers have had one or more members of a potential treatment team take the time to travel and be preceptive. While not all of these centers will be activated and the practice can take over a year in some cases, there is clearly broad-based interest in this therapy, which bodes well for the long-term growth of the business. As we note on every call, it is very difficult to predict pacing. And given where we are at this point in the year, we are modifying our year-end activated center build to 37 active centers with 40 active center treatment centers sometime in the first quarter of 2027. In patient center activation, we are focused on changing prescribing patterns by expanding the set of appropriate patients that treating teams consider for PHP through education, fostering peer-to-peer conversations and evidence generation. First quarter 2026 new patient starts per site have tracked at or slightly higher than the first quarter of 2025 at approximately 0.7 new patients per site per month. New patient starts contribute to revenue over subsequent quarters as patients receive a series of treatments. We expect the strong first quarter new patient starts to offset the reduced site activation pace. Based on conversations with some treating physicians, we know that the publication of the CHOPIN results in Lancet Oncology is already changing treatment patterns at certain centers. One piece of publicly available anecdotal evidence is the recent webinar hosted by the patient advocacy group at Kurinsight, during which Dr. Sid Padia, an interventional radiologist from UCLA, shared his experience treating metastatic uveal melanoma patients with HEPZATO. Some of the patients Dr. Padia is treating with PHP are also being treated with immunotherapy. And he noted on the webinar that his results with these patients are consistent with or perhaps superior in the positive results reported from the CHOPIN trial. As a reminder, CHOPIN response rates improved from approximately 40% with HEPZATO alone to about 76% when HEPZATO was combined with immunotherapy, including some cases of complete response. The combination arm demonstrated a survival benefit with a clear separation between survival curves of both 1 and 2 years. Dr. Padia characterized these study results as extremely encouraging and consistent with his clinical experience. Many metastatic uveal melanoma patients are managed outside REMS-certified centers. So earlier identification and streamlined referral processes are essential. One important approach to enhancing referral patterns is to use multiple data sources to identify physicians treating newly diagnosed metastatic patients and promptly connect these patients with a suitable HEPZATO treatment center. As these networks mature, we expect referrals to be an important driver of new patient starts across our footprint. I now would like to turn to our clinical development programs. In our ongoing metastatic colorectal cancer trial, we continue to activate new trial sites and now have a total of 13 centers who can actively screen CRC patients. We have implemented specialized training modules and streamlined onboarding processes to continue to accelerate site readiness and ensure protocol adherence. We are on track to activate nearly all of the currently targeted 26 trial sites by the end of this year and anticipate presenting interim results in late 2027. To date, we have enrolled 7 patients. While this pace has been slower than initially anticipated, we believe the program is picking up momentum. Our second program in metastatic breast cancer now has 4 clinical trial sites that are prepared to screen patients with additional sites opening soon. Since breast cancer physicians typically have less experience with liver-directed therapies compared to those treating metastatic colorectal cancer, we are conducting targeted education and outreach initiatives to increase awareness of HEPZATO's potential benefit to patients with metastatic breast cancer. We are targeting 15 trial sites and expect to activate them by late 2026. We will provide guidance related to the readouts from this trial later this year as operational progress supports more precise forecasting. We are seeing growing interest in HEPZATO beyond colorectal and breast cancer and are exploring clinical trial designs into additional indications, guided by physician input and advisory board feedback. Based on the results of the CHOPIN trial, there is strong enthusiasm from the medical community to investigate a CHOPIN-like combination regimen to treat liver involvement in patients with a variety of solid tumor types. I look forward to sharing updates on these plans later in the year. I will now ask Sandra to review our financial results. Sandra Pennell: Thank you, Gerard. Total revenue in the first quarter of 2026 was $25 million compared with $19.8 million in the first quarter of 2025. This included $23.3 million of HEPZATO KIT revenue and $1.7 million of CHEMOSAT revenue. Gross margin for the quarter was 85% compared to 86% in the first quarter of 2025. Research and development expenses in the first quarter was $9.8 million compared to $5 million in the prior quarter, driven primarily by continued investment in our clinical organization and the ongoing Phase II trial. Selling, general and administrative expense in the first quarter was $13.1 million compared to $11.3 million in the prior year quarter. This reflects our investment into the continued commercial expansion and increased marketing activities. Net loss for the first quarter was $1.1 million compared to net income of $1.1 million in the prior year first quarter. On a non-GAAP basis, adjusted EBITDA for the quarter was $3.4 million compared to $7.6 million for the first quarter of 2025. We ended the quarter with $89.3 million in cash and investments and no debt. Cash provided by operations was $0.9 million in the quarter. We also purchased approximately 300,000 common shares for about $3 million in the first quarter under the company's approved $25 million share buyback program. To date, we have purchased $9 million worth of common shares. Turning to 2026 guidance. We are confident we will achieve total revenue of at least $100 million, which reflects 20% growth in HEPZATO kit volume over 2025. Our guidance takes into account expected seasonal trends in the third and fourth quarters, much like in 2025 when new patient starts rates declined partially due to scheduling challenges. Forecast for 2026 gross margins remain between 85% to 87%, and we now expect to report positive adjusted EBITDA for the remainder of the year. I want to thank you all for participating today. This does conclude our prepared remarks, and I'd ask the operator to open the phone lines for Q&A. Operator: [Operator Instructions] Your first question comes from Marie Thibault with BTIG. Marie Thibault: I wanted to ask my first here on the volume you're seeing per site. Certainly encouraging to hear that's more than offsetting kind of the slightly slower pace of activations. So I just want to understand what was driving that. It sounds like perhaps CHOPIN is having a bit of an effect. I know in the past, competing or other trials might have been a distraction. So if you can just tell us a little bit more about some of the dynamics behind driving that higher volume. Gerard Michel: Yes. I think it's primarily CHOPIN as well as new sites come on board. Not all of them, but as some of the new sites come on board, when they see the results, they start increasing their volume. So I think it's both things, what they see in practice and the CHOPIN results as well. Clinical trial headwinds are probably reduced a bit from probably similar time last year. But I think the majority of the effect, as best as I can sort out, is CHOPIN and then doctors just seeing the scans and seeing the tumor shrinkage. Marie Thibault: Great to hear. Simple enough. And then I'll ask a follow-up, I think, for Sandra. When we think about the spending trajectory this year, I recall that it is expected to be higher in 2026 than it was in 2025. Can you just give us any more detail, if you have it at this point, on visibility for cadence of that spending, how you see some of the investments in R&D and commercial expansion unfolding throughout this year? Sandra Pennell: Absolutely. So I know in the previous call, we did mention R&D for full year 2026 would be about a 90% increase over 2025. But based on a little bit of acceleration in the enrollment in both trials, we're likely going to see a full year increase closer to the 70% to 75% over 2025. R&D, we will likely see a decent increase in Q2, about 20% over Q1, and start to level off, but about 10% over the remainder of the year and into the fourth quarter. SG&A, probably about a 60% increase in 2026 over 2025 due to the sales force expansion and just increases in selling costs as we grow. Q2 for SG&A, probably a 10% to 15% increase over Q1 due to those marketing initiatives and then increase just modestly each quarter thereafter. Operator: The next question comes from John Newman with Canaccord. John Newman: Congrats on the continued progress. I just wondered if you could talk a little bit about the factors involved regarding the change to the site addition guidance. Obviously, it looks like that's going to be offset by increased patient volume, which is great. But just curious if you could discuss a little bit the different factors that went into that change there. Gerard Michel: Really, the visibility we have in terms of -- there's always about half a dozen or more sites roughly that look like they could go any week. And so the pipeline is full. I want to make sure that's clear. If I don't have patients that I know are scheduled for treatment or multiple patients going through screening, then I'm a little reluctant to say, hey, I'm going to get a couple of sites in the next month or two. The average pace has been a little over — since we've launched has been, I think, about 1.1, 1.2 per month. But if I don't see sites ready to treat a patient or having one scheduled, then I say, all right, I'm going to have another dry month or two, and I pull that out. So, under that framework, I'm saying, yes, it's more likely we'll be 37. Could it be 38 or 39? Yes. But I think 37 is probably a more likely number. And it's as simple as that. We just don't see anything in the next month or so, so I kind of reduce it. John Newman: And then one quick follow-up. On the CHOPIN data, which I think are really fantastic and should be really beneficial, I'm curious if you're seeing most of the new sites that you're in discussion with kind of citing that as a factor for their enthusiasm, or if it's sort of balanced between new and old sites. I'm just curious if perhaps you're seeing kind of the new sites pick up on this in terms of wanting to get on board with the product? Or is it kind of balanced across older existing sites and the new sites? Gerard Michel: All right. So if you're asking the level of enthusiasm from CHOPIN, I think it's both new and existing. There are some existing sites that have been doing a CHOPIN -like protocol from day one when they became active. And there are others that have moved over to that given the data. I would argue that probably most new sites are planning to do a CHOPIN -like protocol, a combination of immunotherapy and PHP. But Kevin, why don't you chime in? You're a little closer to it than I am in terms of would you say almost all the new sites are going with the CHOPIN? Or is it more 50-50? Kevin Muir: I would say that the majority of them will be going with the CHOPIN -like protocol. We hear a lot about just combination treatments in general, but CHOPIN specifically. Now it is kind of important to note the new sites we have been engaged with for months. As you just pointed out, the site opening process takes a considerable amount of time. So when we talk with these sites as they are bringing us on, there are many conversations between peer-to-peer groups as well as our medical and clinical team as well. So everyone is well versed in the CHOPIN -type protocol. And so I would anticipate the majority of them that are coming on in the future will embrace that. Operator: The next question comes from Sudan Loganathan with Stephens. Sudan Loganathan: My first question is regarding the ESMO breast cancer data that you also provided. I noticed that the adverse event profile showed some Grade 3/4 adverse events in about 8% of patients. Additionally, the median overall survival is around 6 months for untreated liver metastatic breast cancer patients, or maybe around the 4- to 5-month range. So just kind of curious on how you're viewing this first set of data for this indication and how this kind of dictates how you go forward? Gerard Michel: Yes. These were all very heavily pretreated patients. And I think probably one of the most important parts of the data is -- although the adverse event profile you mentioned may seem high to oncologists, these events are easily managed and all are resolvable. I think there's not much that can be done for these types of patients that were treated. So I think we're quite happy with the data and glad it's there to help improve recruitment, site activation and recruitment in the clinical trial. I'll ask Vojislav, is there any other commentary you want to add regarding those results? Vojislav Vukovic: Yes, sure. So thanks for the question. In addition to the comments that Gerard made, I'd like to point out that the patients who were treated with HEPZATO in this data review received a median of four prior systemic treatments. That means they have been receiving multiple chemotherapies and many, if not most, of the patients have residual toxicities. So these are not the patients that we have treated before in the FOCUS or Phase III trial, which are typically very little pretreatment or no pretreatment at all. So the safety profile depends also on the line of treatment in which you administer PHP. And regarding your comment about the survival, these are patients with breast cancer and they develop liver metastases. Typically, that's the final stage of the disease where patients have just a few months of life left. So seeing 6 months is actually, in that context, not so bad. And doctors expressed a great deal of satisfaction when we talk to them about being able to manage this very difficult stage of the disease. Sudan Loganathan: I appreciate the details. And then additionally, I just wanted to ask, even as we go into the second half of this year, could we still anticipate a few other data readouts or just other updates on either breast cancer or colorectal cancer indications going forward? Gerard Michel: Yes. There's not going to be any data readouts. I mean we'll keep you apprised of how the trials are proceeding in terms of open sites and patients. But there won't be any data readouts from us. As you know, the product has been on the market as a stand-alone device in Europe for over a decade. And often data comes out that we don't know investigators or clinicians have submitted for a poster presentation or publication. So could something else come out? Yes, but not from the company. Operator: The next question comes from Chase Knickerbocker with Craig-Hallum. Jacob Soucheray: This is Jake on for Chase. Just first, regarding the goal of 40 sites by the first quarter of 2027, for the incremental 11 sites, how much are you relying on the three new sales territories? And what are you seeing from the funnel there? Gerard Michel: Yes. The territories are not new geographies, okay? So we are just slicing the existing territories from 4 to 6 to 9 into smaller territories, so there's more concentrated effort. So there's no particular territory. I think the reason to increase -- there's no particular region where we're going to get more business. As sites are opened, it takes effort to manage open sites. So, to maintain the same level of effort in terms of activating the sites and the same pace of activating the sites, we have to put more bodies in the field. Now these are very experienced reps, bodies. But we have to put more experienced people out there to manage the existing accounts and to maintain the same level of site activation effort. Jacob Soucheray: Okay. And then on guidance, just on a run rate basis, you're already at the $100 million floor just with this quarter. What are your assumptions for the remaining 3 quarters for revenue? Gerard Michel: Yes. Well the assumptions, as I mentioned before, are that we will see the same seasonal impact we saw in the third and fourth quarter of last year. Now we could be wrong there. In hindsight, it could very well be that we're being overly conservative. But we have a very small end in terms of understanding to what extent seasonality will impact things. There are certain aspects of the seasonality that we think we can address and are trying to address. The specific one that we are trying to handle is if at an important center, there is only one full treatment team, let's say there's only one IR or there's only one anesthesiologist who's trained. If they go on vacation, by definition, the capacity has dropped at that center. So, we have implemented a special incentive to the sales force. If you get a second treatment team trained up and going, there will be something in it for the rep. That is yielding some additional backup treatment teams. And I'm hopeful that, that will offset some of the seasonality we saw. There's also seasonality, I think, by patients deciding in certain times of the year, they would rather not be treated. They'll postpone treatment or postpone getting started. That is difficult for us to impact. But for those aspects we can impact, specifically maintaining capacity in terms of training teams, we're doing what we can. But again, getting back to the core of your question, what assumptions are we utilizing given we're already at a run rate to hit guidance, we're assuming we see the same level of seasonality as last year. And again, that might be overly conservative. But I think it's best to guide that way and also to be clear about our assumptions underlying the guidance. Operator: The next question comes from John Newman. John Newman: I had a question about the recent data that you were just discussing earlier on the breast cancer work that was done in Europe. It was interesting, I noticed that the median number of cycles was 1. And I'm wondering if you think that's representative of what we'll see going forward when you test this treatment in perhaps a different set of breast cancer patients and also whether that median cycle may have just been limited by either patient survival or just physicians that maybe hadn't had a lot of experience with the treatment. Gerard Michel: Yes. I will note that the clinical protocol calls for 2 treatments. So I would think that would be the median when the trial reads out. In terms of why they only received one, I have some theories, but let me ask Vojislav to comment. Vojislav Vukovic: Yes. As Gerard mentioned, this was not a prospective trial. This is basically reflecting data from real-world clinical practice. And the practicing physicians were probably making decisions which they thought in the absence of any guiding data are the best for the patients. So just to remind you, these are heavily pretreated patients with a median of 4 prior treatments, quite exhausted with lots of residual toxicities. And I think physicians were probably being cautious and trying to manage the disease, perhaps not to achieve the best possible efficacy, but rather to control the disease and prolong patients' lives, which will be typical the treatment goal after first or second line. So I think that the median number of cycles simply reflects the different treatment objective compared to if you treat patients at an earlier stage in the patient journey. Operator: The next question comes from Yale Jen with Needham & Company. Yale Jen: You refer in the press release that you have 36% volume growth year-over-year of the same quarter. I just wonder whether if you compare to the fourth quarter of last year, what that readout might be? And then I have a follow-up. Gerard Michel: Sandra, do you have the quarter-on-quarter growth off the top of your head? Sandra, you might be on mute. Sandra Pennell: You're correct. I was on mute. I want to say we're mid-20% volume growth from Q1 2026 over Q4 2025. Yale Jen: Okay. Great. That's very helpful. Maybe just a follow-up here that we know that the referral, obviously, is the long-term sort of expansion sources. And so we know that you guys already started the process. And just curious what will be the measurement or other sort of follow-up to track how the referral track is being done and improvements if needed, so on and so forth. So any color on that front? Gerard Michel: Yes. It's interesting that you asked that question because it's something I've grappled with Kevin. Just what we want to do is incentivize our oncology managers to get the referrals going. It is somewhat difficult to know when the patient shows up at the center because obviously, we have the compliance. You can't exactly quiz the doctor on where did this patient come from that sort of thing. So, it's difficult to know, hey, did our referral process lead to this specific patient. We definitely know of cases, many, many cases where the work of the oncology manager resulted in a patient ending up at one of our treating centers. So, it is working. In terms of measuring it on a specific metric, we're grappling with that an accurate metric. We're grappling with that ourselves. How do we follow that. We have some ideas. But right now, I can't point to a specific way we're going to measure that. And it's unlikely that we're going to be able to tell you ever get to the point where we can say, hey, X percent of our patients or the rate of referral is Y per site. I don't think we'll ever get there. Because again, it's HIPAA compliant, you can't quiz the docs, but we're focused very, very much on it. Operator: The next question comes from Charles Wallace with H.C. Wainwright. Charles Wallace: This is Charles on for RK from H.C. Wainwright. So, the first question I have is, I was curious for the CHOPIN publication in the ESMO clinical practice guidelines, are you seeing these 2 publications translate into increased physician adoption in Europe? I know it's a little early, but should we expect kind of that to grow in 2026 from these? Gerard Michel: Yes. I think the European growth is significantly hampered by reimbursement issues. I think many centers in Europe are doing a combination type regime. But to be frank, a lot of European oncologists are less aggressive than they are in the U.S. But I can't really comment as to whether or not I think is it going to grow to increase revenue in Europe over the long-term, certainly. For this particular year, I think we just have to assume that we're going to see probably modest single-digit growth in Europe. What will change that is getting reimbursement in the U.K., which we've been working on for quite a while as well as establishing commercial businesses in Spain, France and Italy, and we're working hard on that as well. In terms of the overall impact on the business, given the price point in Europe, I wouldn't just call it a rounding error, certainly, but it's a plus or minus 10% thing on EBITDA for the business. It's not a huge driver. But we're focused on Europe, as I've mentioned before, primarily at least for the short to medium-term as areas where we can generate data. The drug is approved, the device is approved to deliver melittin to the liver. It is not tied to a specific tumor type. Now most of the usage is in uveal melanoma because that's where most of the data is. But it's a great place to generate run IITs and generate data in other tumor types. So right now, Europe's importance is generation of data. We manage it on a breakeven basis. At some point, we may relaunch the product as a combination drug device as a HEPZATO and try to reset the price point, but that's many, many years down the road. Charles Wallace: I guess one more follow-up for me. So, on the pipeline for mCRC, I think you mentioned that there's 13 sites, but it's been slower-than-expected enrollment with -- I think you said 7 patients. So, I was just curious when you expect enrollment to pick up and ultimately complete for this study? Gerard Michel: Sure. Vojislav, you mind taking that? Vojislav Vukovic: Sure. You're correct. We have opened 13 sites, and we have enrolled thus far 7 patients. Based on the momentum that we've observed over the last several months, we feel confident that the momentum, both in terms of site openings and patient screening and enrollment is picking up. So, we believe that enrollment will proceed in this year and next year and that we'll be able to share interim results publicly by the end of next year, '27. Operator: Thank you. We have reached the end of the question-and-answer session. And this concludes today's conference, and you may now disconnect your lines. Thank you all for your participation. Before you buy stock in Delcath Systems, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Delcath Systems wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $475,926!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,296,608!* Now, it’s worth noting Stock Advisor’s total average return is 981% — a market-crushing outperformance compared to 205% for the S&P 500. 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Interested in Delcath Systems, Inc.? Here are five stocks we like better. Delcath said Q1 was driven by commercial momentum—four U.S. center activations, record new patient starts and 29 REMS‑certified sites—with management attributing higher utilization to CHOPIN data and trimming its year‑end target to 37 active centers (40 by Q1 2027). Financially, Q1 revenue rose to $25.0 million (from $19.8M a year earlier) with an 85% gross margin, a $1.1M net loss, $89.3M in cash, and management reiterated 2026 revenue guidance of at least $100 million while expecting positive adjusted EBITDA for the rest of the year. On the clinical front, the mCRC trial has 13 active screening centers (targeting 26) with seven patients enrolled and interim readout expected in late 2027, the breast cancer program is targeting 15 sites by late 2026, and published CHOPIN results showed response rates rising from ~40% with HEPZATO alone to ~76% when combined with immunotherapy. Delcath Systems (NASDAQ:DCTH) reported first-quarter 2026 revenue growth and reiterated its full-year outlook, while updating expectations for U.S. treatment-center activations and outlining progress across ongoing clinical programs. Executives pointed to record new patient starts and the impact of recently published CHOPIN data as key drivers of momentum for HEPZATO adoption. Chief Executive Officer Gerard Michel said the first quarter was “marked by four center activations and record new patient starts,” calling those metrics core growth drivers. He added that the company is advancing commercial and medical initiatives intended to support long-term growth of HEPZATO, including “building referral networks to quickly connect eligible patients to treating centers.” → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? Michel said the company has “nearly completed” its U.S. commercial expansion into nine regions, and that an expanded medical science liaison (MSL) team is now “fully trained and in the field educating physicians about metastatic uveal melanoma with a focus on the CHOPIN results.” As of the call, Delcath had 29 REMS-certified sites and was in active discussions with “over 50 potential new centers,” according to Michel. He also noted that 38 prospective centers have had at least one potential team member travel for preceptorship training, while cautioning that not all will activate and that “the process can take over one year in some cases.” → A Prada Payday: Is AMC Back in Style? Given pacing uncertainty, Michel said Delcath is modifying its year-end goal to “37 active centers with 40 active treatment centers sometime in the first quarter of 2027,” downshifting from prior expectations as the company looked for clearer visibility into when sites would be ready to treat patients. In response to analyst questions, Michel said the company’s pipeline remains “full,” but he is reluctant to forecast near-term activations without confirmation that patients are scheduled or in screening. “If I don’t see anything in the next month or so I kinda reduce it,” he said. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Beyond site count, management emphasized utilization trends. Michel said first-quarter new patient starts per site were “at or slightly higher than the first quarter of 2025 at approximately 0.7 new patients per site per month,” adding that patients typically receive a series of treatments that contribute to revenue over subsequent quarters. Michel and commercial chief Kevin Muir attributed much of the higher utilization to CHOPIN data and growing real-world confidence among physicians. Michel said, “I think it’s primarily CHOPIN,” also noting that doctors are seeing “the scans and seeing the tumor shrinkage.” Muir added that the “majority” of new sites are expected to use “a CHOPIN-like protocol,” referring to combination treatment approaches. Michel said Delcath is working to improve referral patterns by identifying physicians treating newly diagnosed metastatic patients and connecting them with a suitable HEPZATO center. However, he acknowledged challenges in measuring referral performance due to HIPAA constraints, saying the company is “grappling” with how to track it with a specific metric. Michel said publication of CHOPIN results in The Lancet Oncology is already changing treatment patterns at certain centers. He cited a webinar hosted by patient advocacy group A Cure in Sight in which UCLA interventional radiologist Dr. Siddharth Padia discussed treating metastatic uveal melanoma patients with HEPZATO, including patients also receiving immunotherapy. As a reminder of the study’s findings discussed on the call, Michel said CHOPIN response rates improved from “approximately 40% with HEPZATO alone to about 76% when HEPZATO was combined with immunotherapy,” including some complete responses. He also said the combination arm demonstrated a survival benefit with “a clear separation between survival curves at both 1 and 2 years,” and that Dr. Padia described the results as “extremely encouraging” and consistent with his clinical experience. Michel provided updates on two ongoing trials outside metastatic uveal melanoma. Metastatic colorectal cancer (mCRC): Delcath has activated additional trial sites and now has “a total of 13 centers who can actively screen CRC patients.” Michel said the company is targeting 26 trial sites and is “on track to activate nearly all” by year-end 2026, anticipating interim results in late 2027. To date, seven patients have been enrolled, which Michel said is slower than anticipated but “picking up momentum.” Chief Medical Officer Vojislav Vukovic said the company expects enrollment to proceed through this year and next year, with interim results shared publicly “by the end of next year, 2027.” Metastatic breast cancer: Michel said four clinical trial sites are prepared to screen patients, with additional sites opening soon. The company is targeting 15 trial sites and expects to activate them by late 2026. Michel said Delcath will provide guidance on timing of readouts later in the year as operational progress supports more precise forecasting. On breast cancer data referenced by analysts, Michel said the results reflected heavily pretreated patients and that adverse events, while potentially appearing high “to the untutored,” were “easily managed and all are resolvable.” Vukovic added that patients in the data review had received a median of four prior systemic treatments and likely carried residual toxicities, noting that safety depends on the line of therapy in which the procedure is used. Addressing questions about the median overall survival cited by an analyst, Vukovic said that for breast cancer patients who develop liver metastases, it is often “the final stage of the disease where patients have just a few months of life left,” adding, “Seeing six months is actually…not so bad,” and that physicians expressed satisfaction with being able to manage that disease stage. Regarding the number of treatment cycles in European real-world breast cancer experience, Michel noted that the clinical protocol calls for two treatments and said he would expect that to be the median when the prospective trial reads out. Vukovic characterized the European data as “real world clinical practice,” where physicians may have been cautious and focused on controlling disease and prolonging life in heavily pretreated patients. Michel also said Delcath is seeing interest beyond colorectal and breast cancer and is exploring additional trial designs based on physician input and advisory board feedback, including “a CHOPIN-like combination regimen” across other solid tumors with liver involvement. Chief Financial Officer Sandra Pennell said first-quarter 2026 total revenue was $25.0 million, up from $19.8 million in the first quarter of 2025. Revenue included $23.3 million of HEPZATO KIT revenue and $1.7 million of CHEMOSAT revenue. Gross margin was 85%, compared to 86% a year earlier. Operating expenses rose as Delcath increased investment in both clinical and commercial initiatives. Research and development expense was $9.8 million versus $5.0 million in the prior quarter, driven by “continued investment in our clinical organization and the ongoing phase II trial,” Pennell said. Selling, general and administrative expense was $13.1 million, up from $11.3 million in the prior-year quarter, reflecting “continued commercial expansion and increased marketing activities.” Delcath posted a net loss of $1.1 million, compared with net income of $1.1 million in the first quarter of 2025. Adjusted EBITDA was $3.4 million versus $7.6 million a year earlier. The company ended the quarter with $89.3 million in cash and investments and no debt. Cash provided by operations was $0.9 million. Pennell also said Delcath repurchased about 300,000 common shares for approximately $3.0 million during the quarter under its $25 million buyback program, bringing total repurchases to $9.0 million to date. For 2026, Pennell reiterated guidance for total revenue of at least $100 million, which she said reflects 20% growth in HEPZATO KIT volume over 2025. Guidance assumes seasonal trends in the second half similar to 2025, when new patient start rates declined “partially due to scheduling challenges.” Gross margin guidance remains 85% to 87%, and Pennell said the company now expects to report positive adjusted EBITDA for the remainder of the year. Asked about the impact of CHOPIN’s inclusion in clinical practice guidelines and potential European adoption, Michel said growth in Europe is “significantly hampered” by reimbursement issues. He said Delcath is assuming “modest single-digit growth in Europe” for 2026, and pointed to the importance of securing reimbursement in the U.K. and establishing commercial businesses in Spain, France, and Italy. Michel added that Europe’s near- to medium-term importance is largely in data generation, noting that the device is approved to deliver melphalan to the liver and is “not tied to a specific tumor type.” He said the company manages Europe “on a break-even basis,” and suggested a potential longer-term relaunch as a combination drug-device product could reset pricing, though he described that as “many, many years down the road.” Delcath Systems, Inc is a specialty pharmaceutical and medical technology company focused on the development and commercialization of its proprietary Hepatic CHEMOSAT® Delivery System, designed to deliver high-dose chemotherapeutic agents directly to the liver while minimizing systemic exposure. The company's core technology performs isolated hepatic perfusion, enabling oncologists to administer concentrated melphalan to patients with primary and metastatic liver tumors, including those arising from ocular melanoma. The article "Delcath Systems Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

2026 Revenue Guidance of at least $100M Conference Call Today at 8:30 a.m. Eastern Time QUEENSBURY, N.Y., May 07, 2026--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced financial results and business highlights for the first quarter ended March 31, 2026. First Quarter 2026 Financial Results Total revenue of $25.0 million, compared with $19.8 million in the first quarter of 2025 HEPZATO KIT™ revenue of $23.3 million, compared to $18.0 million in the first quarter of 2025 CHEMOSAT® revenue of $1.7 million, compared to $1.8 million in the first quarter of 2025 Gross margins of 85%, compared to 86% in the first quarter of 2025 Net loss of $1.1 million, compared to a net income of $1.1 million in the first quarter of 2025 Non-GAAP adjusted EBITDA of $3.4 million, compared to $7.6 million in the first quarter of 2025 Cash provided by operations of $0.9 million in the quarter; compared to $2.2 million provided by operations in the first quarter of 2025 Repurchased 316,023 common shares for proceeds of approximately $3.0 million in the first quarter of 2026 under the approved $25 million Share Buyback Program Cash and investments of $89.3 million as of March 31, 2026 Business Highlights Currently 29 active centers Approximately 36% growth in HEPZATO volume in the first quarter 2026 compared to the first quarter 2025 Announced the publication of full results from the investigator-initiated CHOPIN randomized Phase 2 trial in The Lancet Oncology, demonstrating that adding ipilimumab and nivolumab to percutaneous hepatic perfusion significantly improved progression-free survival in metastatic uveal melanoma. Announced that CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (M-PHP) has been included as a recommended liver-directed regional therapy option in the newly published Uveal Melanoma: ESMO–EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up (April 2026) "We delivered a strong first quarter, marked by 20% volume growth over the prior quarter and a strong increase in new patient starts," said Gerard Michel, Chief Executive Officer. "The recent publication of the full CHOPIN results in The Lancet Oncology is already having a meaningful impact on prescribing patterns, further validating HEPZATO KIT and positioning us for continued momentum and long-term value for patients and shareholders alike." 2026 Full Year Financial Guidance The Company’s financial outlook for fiscal year 2026: Total CHEMOSAT and HEPZATO KIT revenue to be at least $100 million, reflecting an increase in HEPZATO KIT volume of at least 20% over 2025 Gross margins in the range of 84% to 87% Positive adjusted EBITDA First Quarter 2026 Results Total revenue for the quarter ending March 31, 2026, was $25.0 million compared to $19.8 million for the same period in the prior year. Revenue in the quarter includes sales of $23.3 million of HEPZATO in the U.S. and $1.7 million of CHEMOSAT in Europe. Research and development expenses for the quarter ending March 31, 2026, were $9.8 million compared to $5.0 million for the same period in the prior year. The increase is primarily due to the continued costs associated with expanding the clinical team, including the share-based compensation expense related to an increase in headcount, and continuation of the Phase 2 clinical trials evaluating HEPZATO. Selling, general and administrative expenses for the quarter ended March 31, 2026, were $13.1 million compared to $11.3 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses, additional personnel in the commercial team and share-based compensation expenses. Net loss for the quarter ended March 31, 2026, was $1.1 million compared to net income of $1.1 million for the same period in the prior year. Non-GAAP adjusted EBITDA for the quarter ended March 31, 2026 was $3.4 million compared to adjusted EBITDA of $7.6 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference. As of March 31, 2026, the Company had $89.3 million in cash and investments, and no debt. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Thursday, May 7, 2026 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-800-717-1738 International: 1-646-307-1865 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1757946&tp_key=463dd4d428 A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website https://investors.delcath.com/news-events/events-and-presentations. GAAP v. Non-GAAP Measures Delcath’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. Delcath has provided in this release certain financial information that has not been prepared in accordance with GAAP. Delcath’s management believes that the non-GAAP adjusted EBITDA described in this release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding Delcath’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in Delcath’s industry. However, the non-GAAP financial measures that Delcath uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP. About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System (HDS) for Melphalan 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. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath’s proprietary HDS. The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Safe Harbor / Forward-Looking Statements The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, including the Company’s statements regarding the possible synergy seen in the successful Phase 2 CHOPIN Trial being transferable to clinical practice; Company’s 2026 financial outlook, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company’s commercialization plans and its ability to successfully commercialize the HEPZATO KIT; contributions to adjusted EBITDA; the Company’s successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company’s successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company’s ability to obtain reimbursement for the HEPZATO KIT; and the Company’s ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company’s filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made. View source version on businesswire.com: https://www.businesswire.com/news/home/20260507125922/en/ Contacts Investor Relations Contact: ICR Healthcare [email protected]

QUEENSBURY, N.Y., April 23, 2026--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today it will host a conference call on May 7, 2026, at 8:30 AM Eastern Time to discuss results for its first quarter ended March 31, 2026. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call. Event Date: Thursday, May 7, 2026 Time: 8:30 AM Eastern Time Participant Numbers: Toll Free: 1-800-717-1738 International: 1-646-307-1865 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1757946&tp_key=463dd4d428 A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website here. About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (Hepzato (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan 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. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to surgically isolate the liver while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. View source version on businesswire.com: https://www.businesswire.com/news/home/20260423827137/en/ Contacts Investor Relations Contact: ICR Healthcare [email protected]