Delcath Systems Reports Preliminary 2025 Revenue of $85.2 Million
- Revenue Growth: Delcath anticipates fourth quarter and full-year 2025 revenues of approximately $20.7 million and $85.2 million, indicating sustained growth potential in the liver cancer treatment sector.
- HEPZATO KIT Performance: Expected revenues for HEPZATO KIT are around $19.0 million and $78.8 million, reflecting strong market demand for the product and further solidifying Delcath's position in liver cancer treatment.
- Share Buyback Program: As of December 31, 2025, the company repurchased 628,572 common shares for $6.0 million, demonstrating confidence in its own value and creating shareholder returns.
- Clinical Trial Progress: HEPZATO procedure volume grew approximately 140% in 2025, showcasing the company's success in promoting new treatment options, which is expected to drive future revenue growth.
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- Revenue Growth: Delcath anticipates fourth quarter and full-year 2025 revenues of approximately $20.7 million and $85.2 million, indicating sustained growth potential in the liver cancer treatment sector.
- HEPZATO KIT Performance: Expected revenues for HEPZATO KIT are around $19.0 million and $78.8 million, reflecting strong market demand for the product and further solidifying Delcath's position in liver cancer treatment.
- Share Buyback Program: As of December 31, 2025, the company repurchased 628,572 common shares for $6.0 million, demonstrating confidence in its own value and creating shareholder returns.
- Clinical Trial Progress: HEPZATO procedure volume grew approximately 140% in 2025, showcasing the company's success in promoting new treatment options, which is expected to drive future revenue growth.
- OPXS Business Growth: Optex Systems Holdings is experiencing rising revenue and expanding margins through the design and manufacture of advanced optical sighting systems, indicating stable demand and financial health in the defense market.
- DCTH Business Transformation: Delcath Systems is commercializing its FDA-approved liver cancer treatment, with revenue gradually increasing, marking a successful transition from development to execution and addressing a serious medical need.
- MAMA Expansion Momentum: Mama's Creations is growing revenue at a healthy pace through fresh food sales in supermarkets and club stores nationwide, while maintaining operational leverage and balance sheet discipline, showcasing sustainable growth potential.
- Common Traits: All three companies are improving financial quality alongside revenue growth, indicating their long-term investment value in the microcap market, quietly strengthening while the market is distracted.

- Clinical Value Reinforced: Delcath Systems' HEPZATO KIT demonstrated consistent tumor responses across nearly all patient categories in the Phase 3 FOCUS study, emphasizing its clinical value as the FDA-approved treatment for unresectable metastatic uveal melanoma.
- Patient Response Analysis: Among 91 participants, patients with lower tumor burden exhibited significantly higher response rates, and safety outcomes remained stable across various demographics, showcasing the therapy's broad applicability.
- Significant Revenue Growth: HEPZATO KIT generated $19.3 million in U.S. revenue during Q3 2025, a substantial increase from $10.0 million in the prior year, further solidifying its position as Delcath's primary commercial driver.
- Importance of Early Intervention: CMO Dr. Vojislav Vukovic highlighted the critical role of early intervention for patients with lower tumor burden, which not only validates the efficacy of HEPZATO KIT but may also drive future market demand.

- Efficacy Analysis: The subgroup analysis from the FOCUS study reveals that patients with tumor burden below the median had an overall response rate (ORR) of 51.1%, significantly higher than 22.2% (p=0.008), indicating the critical importance of early intervention for optimizing treatment outcomes.
- Survival Extension: Patients with tumor burden below the median exhibited a median progression-free survival (PFS) of 11.3 months, significantly longer than 5.8 months (p=0.007), providing essential evidence for clinical treatment strategies.
- Safety Consistency: Safety data across subgroups showed that the incidence of serious adverse events was consistent with the overall study population, with no treatment-related deaths, indicating the manageability and applicability of this therapy.
- Clinical Significance: Delcath's Chief Medical Officer emphasized that these analyses highlight the importance of early intervention in patients with lower tumor burden to maximize clinical benefits, further validating the HEPZATO KIT as a key treatment option.

- Survival Rate Improvement: Delcath's published study reveals that 38 patients with liver-dominant metastatic uveal melanoma, who underwent 99 CHEMOSAT® procedures, achieved a median overall survival of 29.1 months, significantly surpassing previous reports and underscoring the therapy's efficacy and safety.
- Impact of Treatment Cycles: The study indicates that patients receiving ≥3 PHP treatments had a median survival of 29.8 months compared to 21.4 months for those with ≤2 cycles, demonstrating the positive impact of repeated treatment cycles on survival and a ~40% reduction in death risk.
- No Treatment-Related Deaths: The study reported no treatment-related deaths and only 10.5% of patients experienced serious adverse events, highlighting the safety of CHEMOSAT® in real-world applications and enhancing confidence in its clinical use.
- Clinical Evidence Support: This research provides critical clinical evidence for treating liver-dominant metastatic uveal melanoma, emphasizing the importance of high-volume medical centers in optimizing treatment outcomes, which may drive the adoption of new management strategies.

Implied Volatility in Options Market: Delcath Systems, Inc. (DCTH) has seen significant implied volatility in its January 2025 $2.50 Call options, indicating that investors expect a major price movement, potentially due to an upcoming event.
Analyst Sentiment: Currently, Delcath holds a Zacks Rank of #3 (Hold) in the Medical - Instruments Industry, with no analysts increasing their earnings estimates recently, leading to a consensus estimate of a loss of six cents per share for the current quarter.
Options Trading Strategy: The high implied volatility may attract options traders looking to sell premium, as they anticipate that the stock may not move as much as expected by expiration, which is a common strategy to capture decay.
Investment Opportunities: Zacks Investment Research highlights several stocks with high growth potential, suggesting that investors may find opportunities in lesser-known stocks that could yield significant returns in the coming months.






