DelCast Systems (DCTH) Q3 2025: Chopin Data Drives 150% Hepsado Volume Surge Despite Patient Start Dip
Chopin trial results delivered a practice-changing efficacy signal for DelCast’s Hepsado, but operational headwinds in patient starts and site activation pressured near-term revenue and forced a guidance cut. Management’s confidence in long-term demand remains high, as clinical momentum and site expansion underpin a projected 150% increase in Hepsado treatment volume for the year. Investors should watch the interplay between clinical adoption, reimbursement, and operational execution as the company navigates site ramp and pricing dynamics into 2026.
Summary
- Chopin Trial Data Unlocks Combination Therapy Potential: Clinical results position Hepsado plus checkpoint inhibitors as a new standard for liver-dominant metastatic melanoma.
- Operational Execution Faces Patient Start and Scheduling Friction: Summer seasonality and site bottlenecks led to a marked decrease in new patient starts, impacting near-term revenue.
- Forward Focus on Site Expansion and Clinical Adoption: Management is prioritizing additional site activations and clinical education to accelerate recovery and long-term growth.
Performance Analysis
DelCast’s Q3 performance was defined by a mix of clinical validation and operational turbulence. Preliminary unaudited revenue of $20.5 million was accompanied by robust gross margins of 87% and a positive net income, but the quarter was overshadowed by a downturn in new patient starts per site—a function of both seasonality and logistical issues in care delivery. This operational hiccup, combined with the impact of 340B program discounts, led management to lower full-year revenue guidance to $83 to $85 million.
The company’s Hepsado, liver-directed chemotherapy delivery system, continues to show strong underlying demand, with treatment volume projected to grow by 150% versus 2024. However, the law of small numbers amplifies revenue volatility, as each new patient start drives significant incremental revenue and downstream retreatments. Site activation pace rebounded after a summer lull, with four new centers coming online, including Memorial Sloan Kettering, bringing the active site total to 24. Management reiterated confidence in reaching 40 operational centers by end of next year.
- Seasonality and Scheduling Disruptions: Summer vacations and limited trained staff caused a sharp, temporary drop in new patient initiations, with a slow recovery underway.
- 340B Discounts Compress Revenue Per Kit: Average revenue per Hepsado kit declined about 12% due to price concessions, a trend expected to persist near-term.
- Cash Flow and Profitability Intact: Despite top-line pressure, DelCast maintained positive operating cash flow and adjusted EBITDA, supported by high-margin product economics.
While the quarter’s revenue softness clouds near-term visibility, the underlying trajectory remains positive if operational bottlenecks can be resolved and clinical adoption accelerates off the back of Chopin data.
Executive Commentary
"These results clearly demonstrate the benefits of treating early with a combination of systemic checkpoint inhibitors, ipilimumab and nivolumab, and PHP. The option of this 10-week induction regime may accelerate uptake, given some oncologists are uncomfortable postponing systemic treatment."
Gerard Michel, Chief Executive Officer
"It's consistent with what we mentioned, I believe, in our previous call in August, that the discounts are anywhere from 10% to 15% overall. That's a range we did see in Q3, and we expect to see in Q4 as well."
Sandra Pinnell, Chief Financial Officer
Strategic Positioning
1. Clinical Differentiation Through Combination Therapy
Chopin trial results position Hepsado in combination with checkpoint inhibitors as a potent new standard for metastatic uveal melanoma with liver involvement. The trial demonstrated statistically significant improvements in one-year progression-free survival and overall response rates, supporting a shift toward multimodal therapy. This opens pathways for broader adoption among oncologists who previously favored systemic-only approaches and may serve as a template for expansion into other solid tumors with hepatic metastases.
2. Operational Scaling and Site Activation
DelCast’s growth strategy relies on activating and supporting a broad network of treatment centers. Site activations slowed in early Q3 but have since rebounded, with major cancer centers joining the network. The company’s goal of 40 operational centers by end of next year is ambitious, and execution will require continued investment in training, logistical support, and patient referral pathways. Site-level bottlenecks—particularly in interventional radiology suite capacity and team redundancy—remain a key operational risk.
3. Navigating Pricing and Reimbursement Headwinds
Revenue per kit is under pressure from 340B program discounts, which now affect roughly half of volume and are expected to persist. Management is confident that reimbursement for combination protocols will remain robust, especially as Chopin data is published in reputable journals and incorporated into clinical guidelines and compendia. However, the interplay between clinical adoption, payer acceptance, and pricing will be critical as DelCast moves beyond its initial indications.
4. Pipeline Expansion and Indication Optionality
Management signaled intent to explore Hepsado’s utility in other hepatic metastasis-driven cancers, including metastatic colorectal and breast cancer. While these programs are in early stages, the Chopin data provides a proof-of-concept for combination liver-directed and systemic immunotherapy approaches. Advisory boards and protocol development for additional tumor types are underway, creating optionality for long-term growth but requiring careful resource allocation and commercial planning.
Key Considerations
This quarter highlighted the tension between breakthrough clinical data and the realities of operational execution. Investors must weigh the significance of practice-changing trial results against near-term revenue volatility and logistical challenges in scaling a novel therapy platform.
Key Considerations:
- Chopin Data Validates Hepsado’s Clinical Value: Statistically significant improvements in survival and response rates underpin expanding physician interest and guideline inclusion.
- Patient Start Volatility Drives Revenue Swings: With each new patient representing substantial downstream revenue, operational friction can materially impact quarterly results.
- Site Activation Pace Remains a Bottleneck: Achieving the 40-site goal will require aggressive training and support to avoid future summer-like slowdowns.
- Reimbursement and Pricing Dynamics in Flux: 340B discounts and evolving payer policies create ongoing pressure on average selling prices and margin structure.
- Pipeline Expansion Depends on Execution and Evidence: Early signals in other cancers are promising, but commercial readiness and regulatory pathways remain in flux.
Risks
DelCast faces material risks from operational bottlenecks, including limited staff redundancy at treatment centers and scheduling disruptions that can sharply curtail new patient starts. Pricing headwinds from 340B discounts may persist or intensify as volume grows. Regulatory delays, payer pushback, or slower-than-expected adoption of combination protocols could further impact revenue visibility and long-term growth. The company’s reliance on a small number of high-value patient starts magnifies quarterly volatility.
Forward Outlook
For Q4 2025, DelCast guided to:
- Continued Hepsado treatment volume growth, with a projected 150% increase for the full year versus 2024
- Gross margins between 85% and 87%, with positive non-GAAP adjusted EBITDA and operating cash flow
For full-year 2025, management lowered revenue guidance to:
- $83 to $85 million (from prior range), reflecting the impact of summer patient start disruptions and ongoing 340B pricing pressure
Management emphasized the strategic importance of expanding site footprint, improving scheduling resilience, and leveraging Chopin data to accelerate clinical adoption.
- Focus on advisory boards and protocol development for additional tumor types
- Ongoing investment in healthcare professional training to reduce future operational bottlenecks
Takeaways
DelCast’s Q3 was a pivotal inflection point, with breakthrough clinical data offset by operational friction and revenue guidance reset. The company’s long-term thesis remains intact if site expansion and patient recruitment recover as expected.
- Clinical Adoption Inflection: Chopin data catalyzes a shift in oncologist attitudes toward combination therapy, unlocking new patient segments and accelerating guideline momentum.
- Execution Risk Remains Elevated: Near-term revenue swings highlight the importance of operational discipline and site-level resilience as the network scales.
- Watch for Commercial Ramp and Pricing Signals: Investors should monitor site activation pace, patient start recovery, and average revenue per kit as leading indicators of future growth and margin durability.
Conclusion
DelCast delivered a quarter of clinical validation but operational challenge, lowering guidance as patient start volatility and pricing discounts weighed on results. With Chopin data as a catalyst, the company is positioned for long-term growth if it can execute on site expansion and clinical adoption initiatives. The next several quarters will be critical in determining whether DelCast can translate clinical momentum into durable commercial scale.
Industry Read-Through
DelCast’s experience underscores the operational complexities inherent in commercializing novel, procedure-based oncology therapies, especially those requiring multidisciplinary care teams and specialized site training. The Chopin trial’s demonstration of synergy between liver-directed therapy and immune checkpoint inhibitors may have broader implications for other cancer types with hepatic metastases, encouraging similar combination approaches across the industry. Reimbursement and pricing volatility tied to government discount programs is a cautionary signal for other emerging medtech and biotech firms scaling hospital-administered therapies. The importance of site-level operational resilience and patient referral infrastructure is increasingly evident as novel therapies move from clinical validation to commercial reality.