8-K: Delcath Reports Strong Q3, CHOPIN Trial Success

Delcath Systems announced preliminary Q3 2025 financial results and positive Phase 2 CHOPIN trial outcomes for metastatic uveal melanoma.

Summary

• Preliminary unaudited total CHEMOSAT and HEPZATO KIT revenue for Q3 2025 was approximately $20.5 million, with HEPZATO KIT contributing $19.2 million and CHEMOSAT $1.3 million.
• Gross margins for Q3 2025 are expected to be 87%.
• Net income for Q3 2025 was $0.8 million, with positive adjusted EBITDA of $5.3 million and positive operating cash flow of approximately $4.8 million.
• As of September 30, 2025, the company had approximately $88.9 million in cash, cash equivalents, and short-term investments, with no debt.
• Updated 2025 full-year revenue guidance is $83 million to $85 million, reflecting an approximate 150% increase in treatment volume over 2024.
• The CHOPIN Phase 2 trial, comparing PHP alone versus PHP combined with ipilimumab and nivolumab for metastatic uveal melanoma (mUM), met its primary endpoint.
• The combination group achieved a one-year progression-free survival of 54.7% (95% CI: 36.8 69.5) compared to 15.8% (95% CI: 5.8 30.1) for the PHP group (P<0.001).
• Median progression-free survival was 12.8 months (95% CI: 9.2 15.4) for the combination group versus 8.3 months (95% CI: 6.0 9.6) for the PHP group, with a Hazard Ratio of 0.34 (0.19 0.60).
• Overall survival at two years was 49.6% (95% CI: 29.3 67.0) for the combination group compared to 22.1% (95% CI: 7.9 40.6) for the PHP group (P=0.006).
• The best overall response rate was 76.3% (95% CI: 59.4 88.0) for the combination group versus 39.5% (95% CI: 24.5 56.5) for the PHP group (P<0.001).

Sentiment

Score: 8

Explanation: The filing presents very strong positive clinical trial results for a combination therapy that significantly improves patient outcomes in a challenging cancer. This is coupled with positive preliminary financial results and optimistic full-year guidance, indicating strong commercialization progress and future growth potential, despite a slight sequential revenue dip attributed to seasonality and discounts.

Positives

• The CHOPIN Phase 2 trial met its primary endpoint, demonstrating significantly improved progression-free survival, overall survival, and best overall response rate for the combination therapy (PHP + ICI) in metastatic uveal melanoma.
• Preliminary Q3 2025 financial results show positive net income ($0.8 million), positive adjusted EBITDA ($5.3 million), and positive operating cash flow (approximately $4.8 million).
• High gross margins are expected at 87% for Q3 2025 and between 85% to 87% for the full year 2025.
• The company maintains a strong cash position with approximately $88.9 million in cash, cash equivalents, and short-term investments and no debt as of September 30, 2025.
• Updated 2025 full-year revenue guidance of $83 million to $85 million reflects an approximate 150% increase in treatment volume over 2024.
• The combination treatment was well tolerated, with adverse events consistent with individual use of PHP and checkpoint inhibitors, and no new safety signals identified.
• The potential synergy of PHP and ICI therapy observed in the CHOPIN trial may be transferable to other cancers with liver-dominant disease.

Negatives

• Q3 2025 revenue was modestly lower than Q2, primarily due to NDRA discounts and unexpected summer seasonality impacting new patient starts.
• Grade 3 or higher treatment-related adverse events were more frequent in the combination group (81.6% vs. 40.5%), although most were manageable with standard care.

Risks

• Uncertainties exist regarding commercialization plans and the ability to successfully commercialize the HEPZATO KIT.
• Successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components, is crucial.
• Successful FDA inspections of Delcath's facilities and those of its third-party suppliers/manufacturers are required.
• Successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy is necessary.
• The ability to obtain reimbursement for the HEPZATO KIT is a factor.
• The ability to successfully enter into necessary purchase and sale agreements with users of the HEPZATO KIT is important.
• Preliminary estimated financial results are unaudited and subject to completion of quarter-end procedures, potentially differing materially from actual results.
• New risk factors and uncertainties may emerge, and it is not possible to predict all of them.
• Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially.

Future Outlook

The company expects strong growth in 2026 and beyond, driven by the ongoing expansion of active treatment centers and the positive influence of the CHOPIN trial results. Full-year 2025 revenue guidance is $83 million to $85 million, reflecting an approximate 150% increase in treatment volume over 2024, with positive adjusted EBITDA and operating cash flow expected in each quarter of 2025. The company also looks forward to investigating the potential transferability of PHP and ICI therapy synergy to other cancers with liver-dominant disease.

Management Comments

• "Although our third quarter revenue was modestly lower than the second quarter, this decline was primarily due to the NDRA discounts and unexpected summer seasonality which impacted the scheduling of new patient starts. We are confident that we will achieve strong growth in 2026 and beyond. This expectation is based on our ongoing expansion of active treatment centers and the positive influence of the CHOPIN trial results, which have demonstrated impressive efficacy and offer practical advantages for initiating patients on systemic therapy, while preparing for PHP therapy." Gerard Michel, Chief Executive Officer.
• "The CHOPIN trial clearly demonstrates that adding ipilimumab and nivolumab to PHP is both effective and tolerable. The efficacy results are impressive, especially when considering the treatment regime included only two PHP treatments and did not include nivolumab maintenance. Since many oncologists start systemic therapy first, this approach provides valuable lead time for patient assessment and scheduling PHP, helping to overcome logistical barriers and support broader adoption and nearto medium-term uptake." Gerard Michel, Chief Executive Officer.
• "In addition to the potential immediate benefit to patients with metastatic uveal melanoma, the possible synergy of PHP and ICI therapy seen in the successful Phase 2 CHOPIN trial may be transferable to other cancers with liver-dominant disease, and Delcath looks forward to investigating that potential." Dr. Vojislav Vukovic, Chief Medical Officer.

Industry Context

The CHOPIN trial addresses a critical challenge in oncology, as patients with liver metastases often experience poorer outcomes when treated with immune checkpoint inhibitors (ICIs) compared to those with metastases elsewhere, a phenomenon observed across various tumor types including melanoma, non-small-cell lung cancer, urothelial carcinoma, and renal cell carcinoma. This diminished efficacy is attributed to the immunosuppressive nature of the liver microenvironment. The successful combination of Delcath's CHEMOSAT Hepatic Delivery System with melphalan (HEPZATO KIT) and systemic ICIs (ipilimumab and nivolumab) for metastatic uveal melanoma (mUM) offers a promising strategy to overcome this, potentially setting a new standard for mUM treatment and opening avenues for treating other liver-dominant cancers where ICI efficacy is limited.

Comparison to Industry Standards

• Large, randomized clinical trials consistently show that patients with liver metastases typically have poorer outcomes than those with metastases elsewhere when treated with immune checkpoint inhibitors (ICIs) across multiple tumor types, including melanoma, non-small-cell lung cancer (NSCLC), urothelial carcinoma, and renal cell carcinoma.
• This diminished efficacy of ICIs in liver metastases is attributed to the well-documented immunosuppressive nature of the liver microenvironment.
• The CHOPIN trial's combination group (PHP + ICI) achieved a 1-year progression-free survival of 54.7% and a 2-year overall survival of 49.6% in mUM patients, significantly outperforming PHP alone (1-year PFS 15.8%, 2-year OS 22.1%). These results are impressive given the known challenges of treating liver metastases with ICIs alone and the typically poor prognosis for mUM.
• The trial's approach, allowing oncologists to start systemic therapy first and providing lead time for PHP scheduling, offers practical advantages that can help overcome logistical barriers and support broader adoption, contrasting with the complexities often associated with integrating novel therapies.

Stakeholder Impact

• Shareholders are likely to be positively impacted by the strong clinical trial results, positive financial performance, and optimistic future outlook, which could lead to increased stock value.
• Patients with metastatic uveal melanoma stand to benefit significantly from the combination therapy, which demonstrated substantially improved progression-free survival, overall survival, and response rates for this difficult-to-treat cancer.
• Healthcare providers gain a new, effective, and tolerable treatment option for mUM, with a treatment approach that offers practical advantages for patient assessment and scheduling, potentially overcoming logistical barriers.
• Employees can anticipate a positive outlook for company growth and stability, driven by clinical success and commercial expansion.

Next Steps

• Delcath Systems will host a conference call and webcast on October 20, 2025, at 8:45 a.m. Eastern Time to discuss the Phase 2 CHOPIN Trial results and provide a brief overview of the financial results.
• The company plans to continue expanding active treatment centers for HEPZATO KIT.
• The company aims to accelerate the referral of metastatic uveal melanoma patients to treatment sites.
• Delcath looks forward to investigating the potential transferability of PHP and ICI therapy synergy to other cancers with liver-dominant disease.

Key Dates

Recommendation

The CHOPIN Phase 2 trial results are exceptionally strong, demonstrating a significant improvement in key efficacy endpoints (PFS, OS, ORR) for the combination therapy in metastatic uveal melanoma, a challenging indication. This clinical success, combined with positive preliminary Q3 financial results, high gross margins, a robust cash position, and optimistic full-year revenue guidance (150% treatment volume increase), indicates strong commercial momentum and significant future growth potential. The strategic implications of combining PHP with ICIs, potentially transferable to other liver-dominant cancers, further enhance the long-term value proposition. While there was a modest sequential revenue dip, it was attributed to temporary factors, and management remains confident in strong growth for 2026 and beyond. This filing presents compelling evidence of both clinical and commercial success, making it a strong buy for investors.

Keywords

Delcath Systems, DCTH, CHOPIN Trial, Metastatic Uveal Melanoma, mUM, HEPZATO KIT, CHEMOSAT, Hepatic Delivery System, PHP, Percutaneous Hepatic Perfusion, Melphalan, Ipilimumab, Nivolumab, Immune Checkpoint Inhibitors, ICI, Oncology, Liver Cancer, Financial Results, Revenue Guidance, Clinical Trial, Phase 2, EBITDA, Cash Flow, FDA, ESMO