Financial Data and Key Metrics Changes - In 2025, the company achieved record revenue of $85.2 million, representing over 40% volume growth compared to the previous year [6][7] - The fourth quarter revenue was $20.7 million, with gross margins of 85% for the quarter and 86% for the full year, compared to 86% and 83% in the prior year [18][21] - The net loss for the fourth quarter was $1.9 million, an improvement from a $3.4 million loss in the same quarter of the previous year, while the full year net income was $2.7 million compared to a loss of $26.4 million in 2024 [20] Business Line Data and Key Metrics Changes - Revenue from HEPZATO was $19 million in Q4 2025, up from $13.7 million in Q4 2024, while CHEMOSAT revenue was $1.7 million compared to $1.4 million in the same period [18] - For the full year, HEPZATO revenue was $78.8 million, significantly higher than $32.3 million in 2024, and CHEMOSAT revenue increased to $6.4 million from $4.9 million [18] Market Data and Key Metrics Changes - The company operates 28 active treatment centers and aims to expand to 40 by the end of 2026, with significant interest from leading cancer centers [9][10] - The average number of new patients treated per site per month was approximately 0.75 in early 2026, compared to 0.5 for the full year of 2025 [11] Company Strategy and Development Direction - The company has organized its commercial strategy around three priorities: expanding site capacity, changing prescribing patterns, and developing referral networks [8][15] - The CHOPIN data publication is expected to drive revenue acceleration and enhance the company's market position [6][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth driven by site activations and the anticipated impact of the CHOPIN results [6][15] - The company expects to guide for total revenue of at least $100 million in 2026, reflecting a greater than 20% increase in HEPZATO procedure volume [22][23] Other Important Information - Research and development expenses for 2025 were $29.2 million, up from $13.9 million in 2024, with expectations for a nearly 90% increase in 2026 [19] - The company ended 2025 with approximately $91 million in cash and investments, and no outstanding debt obligations [22] Q&A Session Summary Question: Clarification on guidance assumptions and seasonality - Management confirmed that seasonality is expected in the third quarter, with modest growth anticipated from Q2 to Q3 [25][26] Question: Difference between HEPZATO KIT REMS site and commercial sites - Management clarified that HEPZATO KIT REMS sites must be compliant and cannot accept referrals until they have treated their first patient [30][32] Question: Timing of CHOPIN study publication and its impact - Management indicated that the CHOPIN study publication is imminent, expected within a month, and will be used to inform treating physicians [39][40] Question: Average treatments per patient and new patient starts - The average number of treatments per patient remains around 4.1, with new patient starts expected to average close to 0.5 per site per month [44][48] Question: Potential catalysts for the third quarter - Management acknowledged that while seasonality is a concern, the CHOPIN publication could serve as a catalyst for increased site activations [58][59]

Financial Data and Key Metrics Changes - In 2025, the company achieved record revenue of $85.2 million, representing over 40% volume growth compared to the previous year [6][7] - The fourth quarter revenue was $20.7 million, with gross margins of 85% for the quarter and 86% for the full year, compared to 86% and 83% in the prior year [18][21] - The net loss for the fourth quarter was $1.9 million, an improvement from a $3.4 million loss in the same quarter of the previous year, while the full year net income was $2.7 million compared to a loss of $26.4 million in 2024 [20] Business Line Data and Key Metrics Changes - Revenue from HEPZATO was $19 million in the fourth quarter and $78.8 million for the full year, compared to $13.7 million and $32.3 million in the same periods of 2025 [18] - CHEMOSAT revenue was $1.7 million for the fourth quarter and $6.4 million for the full year, compared to $1.4 million and $4.9 million in 2024 [18] Market Data and Key Metrics Changes - The company operates 28 active treatment centers and aims to expand to 40 by the end of 2026, with significant interest from leading cancer centers [9][10] - The average number of new patients treated per site per month was approximately 0.75 in early 2026, up from 0.5 in 2025 [11] Company Strategy and Development Direction - The company’s commercial strategy focuses on three priorities: expanding site capacity, changing prescribing patterns, and developing referral networks [8][15] - The CHOPIN data publication is expected to drive revenue acceleration and enhance the company’s market position [6][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth driven by site activations and the anticipated impact of the CHOPIN results [6][15] - The company expects to guide total revenue of at least $100 million for 2026, reflecting a greater than 20% increase in HEPZATO procedure volume [22][23] Other Important Information - Research and development expenses for 2025 were $29.2 million, with an expected increase of nearly 90% in 2026 due to ongoing clinical trials [19] - The company ended 2025 with approximately $91 million in cash and investments, indicating a strong financial position [22] Q&A Session Summary Question: Clarification on guidance assumptions and seasonality - Management confirmed that seasonality is expected in the third quarter, with modest growth anticipated from Q2 to Q3 [25][26] Question: Difference between HEPZATO KIT REMS site and clinical trial sites - Management clarified that only compliant REMS sites accepting referrals will be listed on the HEPZATO KIT website [30][31] Question: Timing of CHOPIN study publication and its impact - Management indicated that the CHOPIN study publication is imminent and will be used to inform treating physicians and potentially update guidelines [39][40] Question: Average treatments per patient and new patient starts - The average number of treatments per patient remains around 4, with new patient starts expected to average close to 0.5 per site per month [44][46] Question: Potential catalysts for the third quarter - Management acknowledged that while seasonality may impact the third quarter, the CHOPIN publication could serve as a catalyst for growth [56][58]

Financial Data and Key Metrics Changes - In 2025, the company achieved record revenue of $85.2 million, representing over 40% volume growth compared to the previous year [6][19] - The fourth quarter revenue was $20.7 million, with HEPZATO sales at $19 million and CHEMOSAT at $1.7 million, compared to $13.7 million and $1.4 million respectively in Q4 2025 [19] - Gross margins were 85% in Q4 and 86% for the full year, compared to 86% and 83% in the prior year [19] - The net loss for Q4 2025 was $1.9 million, an improvement from a $3.4 million loss in Q4 2024, while the full year net income was $2.7 million compared to a loss of $26.4 million in 2024 [21] Business Line Data and Key Metrics Changes - Revenue from HEPZATO increased significantly from $32.3 million in 2024 to $78.8 million in 2025, while CHEMOSAT revenue rose from $4.9 million to $6.4 million [19] - The average number of treatments per patient has remained consistent at approximately four cycles since launch [7] Market Data and Key Metrics Changes - The company operates 28 active treatment centers and aims to expand to 40 by the end of 2026 [9] - The average rate of new patient starts per site per month was approximately 0.75 for the first two months of 2026, compared to an average of 0.5 for the full year of 2025 [11] Company Strategy and Development Direction - The company’s commercial strategy focuses on three priorities: expanding site capacity, changing prescribing patterns, and building referral networks [7][15] - The CHOPIN data publication is anticipated to drive revenue acceleration and enhance the company’s market position [6][12] - The company is actively engaging key opinion leaders to support updates to the NCCN guidelines for metastatic uveal melanoma [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth driven by site activations and the anticipated impact of the CHOPIN results [6][15] - The company expects to guide total revenue of at least $100 million for 2026, reflecting a greater than 20% increase in HEPZATO procedure volume [22][23] Other Important Information - Research and development expenses for 2025 were $29.2 million, up from $13.9 million in 2024, with expectations for a nearly 90% increase in 2026 [20] - The company ended 2025 with approximately $91 million in cash and investments, and no outstanding debt obligations [22] Q&A Session Summary Question: Clarification on guidance assumptions and seasonality - Management confirmed that seasonality is expected in the third quarter, with modest growth anticipated from Q2 to Q3 [26][28] Question: Difference between HEPZATO KIT REMS sites and clinical trial sites - Management clarified that HEPZATO KIT REMS sites must be compliant and cannot accept referrals until they have treated their first patient [31][33] Question: Timing of CHOPIN study publication and its impact - Management indicated that the CHOPIN study publication is imminent, expected within a month, and will be used to educate treating physicians [39] Question: Average treatments per patient and new patient starts - The average treatments per patient remain around 4.1, with intervals stretching closer to 8 weeks [45][48] Question: Potential for NCCN guideline updates - Management noted that updates to the NCCN guidelines are driven by key opinion leaders and are hopeful for changes based on new data [82]

Group 1 - Delcath Systems, Inc. is an interventional oncology company focused on treating primary and metastatic cancers of the liver [1] - The company will be attending the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference in Snowbird, Utah [1]

Core Viewpoint - Delcath Systems, Inc. has announced preliminary financial results for Q4 and the full year 2025, highlighting significant revenue growth and ongoing clinical advancements in the treatment of liver cancers [1][2]. Financial Results - Total revenue for Q4 2025 is expected to be approximately $20.7 million, while full-year revenue is projected at $85.2 million [6]. - Revenue from the HEPZATO KIT for Q4 and the full year is anticipated to be around $19.0 million and $78.8 million, respectively [6]. - CHEMOSAT revenue for Q4 and the full year is expected to be approximately $1.7 million and $6.4 million, respectively [6]. - The company has repurchased 628,572 common shares for $6.0 million under a $25.0 million Share Buyback Program [6]. - As of December 31, 2025, Delcath had approximately $91.0 million in cash and short-term investments, an increase from $88.9 million as of September 30, 2025, with no debt [6]. Business Highlights - There was approximately 140% growth in HEPZATO procedure volume in 2025 compared to 2024 [6]. - The company plans to enhance the adoption of HEPZATO by raising awareness of the CHOPIN study findings among treating physicians [5]. - Independent investigators presented positive results from the Phase 2 CHOPIN trial at the 2025 European Society of Medical Oncology Annual Congress, showing significant improvement in one-year progression-free survival when combining CHEMOSAT with ipilimumab and nivolumab [6]. - Recent publications have emphasized the efficacy of percutaneous hepatic perfusion (PHP) in managing metastatic uveal melanoma, showcasing long-term survival outcomes and clinical experiences [6]. Product Information - Delcath Systems focuses on interventional oncology, specifically targeting primary and metastatic liver cancers with its proprietary products, HEPZATO KIT and CHEMOSAT [7]. - HEPZATO KIT is a combination drug and device product approved by the FDA for treating adult patients with metastatic uveal melanoma with unresectable hepatic metastases [8]. - In Europe, CHEMOSAT is regulated as a Class III medical device and has been utilized in major medical centers for various liver cancer treatments [9].

Company Overview - Delcath Systems, Inc. (NASDAQ:DCTH) specializes in interventional oncology treatments for liver cancers, with main products including the HEPZATO KIT and CHEMOSAT Hepatic Delivery System [4] Financial Performance - For fiscal Q3 2025, Delcath reported revenue of $20.6 million, a significant increase from $11.2 million in the same quarter last year [2] - The company's EPS was $0.02, exceeding consensus estimates by $0.08 [2] - Revenue from the HEPZATO KIT grew to $19.3 million from $10 million year-over-year, while CHEMOSAT revenue increased from $1.2 million to $1.3 million [2] - Gross margins improved from 85% to 87% during the same period [2] Guidance and Outlook - Despite strong Q3 performance, management lowered full-year revenue guidance to a range of $83 million to $85 million, down from the previous range of $93 million to $96 million [3] - The reduction in guidance is attributed to a slowdown in new patient starts, partially due to seasonal factors [3] Analyst Rating - Analyst Swayampakula Ramakanth from H.C. Wainwright reiterated a Buy rating on Delcath but lowered the price target from $31 to $30 [1]

Delcath Systems (NasdaqCM:DCTH) Update Summary Company Overview - **Company**: Delcath Systems - **Industry**: Oncology, specifically focusing on treatments for metastatic uveal melanoma Key Points from the Call Chopin Trial Results - The Chopin trial involved 76 patients randomized to receive either percutaneous hepatic perfusion (PHP) alone or a combination of PHP with ipilimumab and nivolumab [6][8] - **Primary Endpoint**: One-year progression-free survival (PFS) was 54.7% in the combination group versus 15.8% in the PHP group [9] - **Overall Survival**: The combination therapy showed a median overall survival of 23.1 months compared to 19.6 months for PHP alone [9] - **Response Rates**: Best overall response rates were 76.3% for the combination group versus 39.5% for PHP alone [9] - **Adverse Events**: Grade 3 or higher treatment-related adverse events were more frequent in the combination group (81.6% vs. 40.5%) but were manageable [9][18] Implications for Clinical Practice - The results are considered practice-changing, suggesting that the combination of ipilimumab and PHP should be offered to eligible patients [21] - There is a need for further studies to understand the immune versus cytotoxic mechanisms behind the observed efficacy [20] - The combination therapy may be particularly beneficial for patients with both hepatic and extrahepatic disease [21] Financial Results and Guidance - **Q3 2025 Preliminary Results**: Revenue of $20.5 million, gross margins of 87%, net income of $0.8 million, and positive adjusted EBITDA of $5.3 million [32] - **Cash Position**: As of September 30, 2025, the company reported $88.9 million in cash and equivalents [33] - **Revenue Guidance**: The company lowered its revenue guidance for 2025 to $83 million to $85 million due to a slowdown in new patient starts and the impact of 340B discounts [35] - **Treatment Volume Projection**: Total HEPZATO KIT treatment volume is projected to increase by approximately 150% compared to 2024 [36] Market Dynamics - There was a noted decrease in new patient starts per site, attributed to seasonality and scheduling issues [34][50] - The company is optimistic that the Chopin trial data will encourage quicker adoption of combination therapies among oncologists [39][41] - Interest from major cancer centers remains strong, with expectations to have 40 operational centers by the end of next year [33] Additional Insights - The combination therapy's efficacy may lead to a shift in treatment paradigms for other cancers with liver metastases [27][29] - The company is focused on training additional healthcare professionals to administer HEPZATO KIT to mitigate scheduling conflicts [34] - The feedback from oncologists indicates that HEPZATO KIT addresses a significant unmet need in the treatment landscape [35] Conclusion Delcath Systems is positioned to leverage the positive results from the Chopin trial to enhance its market presence and treatment adoption for metastatic uveal melanoma. The financial outlook reflects challenges but also opportunities for growth as the company navigates the complexities of patient recruitment and treatment administration.

CHOPIN Trial Results - The CHOPIN trial demonstrated that adding ipilimumab and nivolumab to PHP is effective and tolerable [9] - The combination group showed a one-year progression-free survival rate of 54.7% (95% CI: 36.8 - 69.5) compared to 15.8% (95% CI: 5.8 - 30.1) in the PHP group [6] - Median progression-free survival was 12.8 months (95% CI: 9.2 - 15.4) in the combination group versus 8.3 months (95% CI: 6.0 - 9.6) in the PHP group [6] - The hazard ratio for progression-free survival was 0.34 (0.19 - 0.60), with P<0.001 [6] - One-year overall survival was 82.8% (95% CI: 65.6 - 91.9) in the combination group and 82.2% (95% CI: 64.5 - 91.6) in the PHP group [6, 7] - Two-year overall survival was 49.6% (95% CI: 29.3 - 67.0) in the combination group and 22.1% (95% CI: 7.9 - 40.6) in the PHP group [7] - Median overall survival was 23.1 months (95% CI: 20.2 - 38.5) in the combination group and 19.6 months (95% CI: 15.2 - 21.8) in the PHP group [7] - The hazard ratio for overall survival was 0.39 (0.20 - 0.77), with P = 0.006 [7] - The best overall response rate in the combination group was 76.3% (59.4 - 88.0) [7] - Grade 3 or higher treatment-related adverse events were more frequent in the combination group (81.6% vs 40.5%, P<0.001) [7] Company Statements - Delcath Systems is focused on the treatment of primary and metastatic liver cancers [2, 14]

Core Insights - Delcath Systems, Inc. reported preliminary revenue results for Q3 2025, indicating a total revenue of approximately $20.5 million from its CHEMOSAT and HEPZATO KIT products [1] - The revenue breakdown shows HEPZATO KIT generated $19.2 million, while CHEMOSAT revenue was not fully disclosed [1] Financial Performance - Total revenue for CHEMOSAT and HEPZATO KIT reached around $20.5 million for the quarter ended September 30, 2025 [1] - HEPZATO KIT specifically contributed $19.2 million to the total revenue [1]

Core Insights - Several small- and mid-cap biotech and medical stocks experienced significant after-hours trading activity on September 26, driven by clinical updates, investor presentations, and strategic announcements. Company Summaries - **Enanta Pharmaceuticals Inc. (ENTA)**: The stock surged 20% in after-hours trading to $9.48 after closing at $7.90, following the announcement of upcoming topline results from its Phase 2b study on zelicapavir for RSV treatment in high-risk adults [2][3]. - **Acumen Pharmaceuticals Inc. (ABOS)**: Shares rebounded 12.67% to $1.60 after closing at $1.42, driven by renewed interest in its Alzheimer's pipeline, particularly the Phase 2 candidate Sabirnetug (ACU193) [4]. - **Delcath Systems Inc. (DCTH)**: The stock gained 6.00% in after-hours trading to $11.39 after closing at $10.74, following renewed investor interest in its CHOPIN Phase 2 trial data presentation scheduled for ESMO 2025 Congress [5][6]. - **Vivos Therapeutics Inc. (VVOS)**: The stock climbed 4.81% to $3.27 after closing at $3.12, likely due to renewed interest following recent positive clinical trial results for its pediatric OSA treatment [7][8]. - **Xilio Therapeutics (XLO)**: Shares rose 4.28% to $0.83 after closing at $0.7959, driven by enthusiasm surrounding the initiation of a Phase 2 trial for its tumor-activated IL-12 candidate, which also triggered a $17.5 million payment from Gilead [9][10]. - **Nyxoah SA (NYXH)**: The stock increased 3.77% to $4.68 after closing at $4.51, supported by optimism regarding its international expansion and a recent patent infringement lawsuit against Inspire Medical Systems [11].