Bill Maughan

Bill Maughan asked if Delcath is satisfied with the volume increase attributed to the expansion into 340B hospitals following the pricing reset in mid-2025. He also sought comments on any observed changes in competitive pressure from clinical trials, specifically mentioning Replimune and Thomas Jefferson, and whether the completion of enrollment in trials like IDEA has made more patients available.

Answer

Gerard Michel, CEO, stated that it is impossible to definitively quantify the volume increase directly from 340B pricing, but confirmed it is not a hindrance. Regarding competitive trials, Mr. Michel noted a significant expansion of Replimune and Thomas Jefferson active sites in Q2 2025, which diverted some patients. However, he highlighted that the IDEA trial finished enrolling late last year, leading to a diminished competitive pressure and a less severe headwind compared to the previous year.

Bill Maughan asked if Delcath Systems is satisfied with the volume increase observed since the 340B pricing reset around mid-2025. He also requested comments on the impact of competitive trials, specifically mentioning Replimune, Thomas Jefferson, and the IDEA trial, regarding their effect on patient availability.

Answer

Gerard Michel, CEO, stated it's impossible to quantify the direct volume increase attributable to 340B pricing, but confirmed it is not a hindrance. Regarding competitive trials, Michel noted a significant expansion of Replimune and Thomas Jefferson trials in Q2 2025, which did divert some patients. However, he highlighted that the IDEA trial concluded enrollment late last year, leading to a diminished competitive pressure and a less severe headwind compared to the previous year.

Bill Maughan of Clear Street questioned the sustainability of the current treatment rate of two per month per center, asking if it could change and if the next cohort of centers would have lower utilization rates.

Answer

CEO Gerard Michel stated that while some high-volume centers face capacity constraints, the company is working to build referral networks and train second teams to potentially increase capacity. He does not believe the next 20 sites will necessarily be less attractive, as referral networks can be built to support them, suggesting average rates could be maintained or grow.

Bill Maughan asked about the differentiation of RGX-202 from Sarepta's Elevidys, specifically questioning if the immune modulation regimen is the primary driver of differentiation and if its application to Elevidys could yield similar safety results.

Answer

President & CEO Curran Simpson responded that it is difficult to isolate the individual effects of product purity, manufacturing, and the immune regimen, as they all contribute to the overall profile. CMO Dr. Steve Pakola added that the components likely interact and that Regenxbio is the only company with clinical data on this specific combination, making it impossible to know how the regimen would perform with another product.

Bill Maughan from Clear Street asked if excluding patients with high OCT fluctuations from the SOLAR trial to reduce noise could lead to a restrictive label or negative perception among prescribers.

Answer

Pravin Dugel, Executive Chairman, President & CEO, stated it would have the opposite effect. He argued that for clinicians, this de-risking provides more scientifically valid data. From a regulatory standpoint, he asserted that history shows this approach does not lead to label restrictions, citing his personal experience at Iveric Bio and other well-known retina trials like ANCHOR and MARINA as precedents.