Eva Fortea-Verdejo

Eva Fortea-Verdejo inquired about ARCALYST's growth dynamics for the quarter and the key drivers for determining the KPL-387 phase 3 dose, particularly regarding the phase 2 study's design.

Answer

Mark Ragosa (CFO, Kiniksa Pharmaceuticals) stated that the growth to net for the quarter year-to-date was 8.9%, lower than Q2's 9.5%, following a historical pattern of highest in Q1 and lower in Q2/Q3. John Paolini (CMO, Kiniksa Pharmaceuticals) clarified that the KPL-387 phase 2 is a dose-focusing study, anchored on the 300 mg subcutaneous monthly dose, designed to confirm its sufficiency, assess if every-other-week dosing provides additional efficacy, and identify if lower doses are weaker, thereby affirming the 300 mg monthly dose for phase 3.

Eva Fortea-Verdejo of Wells Fargo asked if there were differences in Arcalis therapy duration between patients in their first recurrence versus those with multiple recurrences, and how the company balances maintaining annual cash flow positivity with funding new studies for KPL-387.

Answer

EVP & CCO Ross Moat responded that they have not observed meaningful differences in therapy duration between patient cohorts yet, reiterating the 30-month average. CFO Mark Ragosa stated that the company's financial discipline and commercial execution provide the capacity to invest in pipeline advancement and other value-creating initiatives while expecting to remain cash flow positive on an annual basis.

Eva Fortea-Verdejo of Wells Fargo inquired about Kiniksa's strategies for expanding its prescriber base and the outlook for this growth, and also asked for the gross-to-net percentage in Q1.

Answer

Chief Commercial Officer Ross Moat explained that prescriber growth is driven by targeted field execution and digital marketing. He noted Q1 2025 gross-to-net was 10.7%, lower than Q1 2024's 13.5% due to a one-time bolus of Medicare Part D patients converting from free goods to commercial therapy, which reduced the proportion of patients needing co-pay assistance.

Eva Fortea-Verdejo from Wells Fargo asked how KPL-387 is differentiated from ARCALYST beyond its dosing schedule and whether Kiniksa owns the full rights to KPL-387 and KPL-1161.

Answer

Dr. John Paolini, Chief Medical Officer, explained that KPL-387 is a monoclonal antibody with a distinct mechanism but shares the ability to block both IL-1 alpha and beta, enabling a stable liquid formulation for monthly dosing. Sanj K. Patel, Chief Executive Officer, confirmed that Kiniksa independently developed and wholly owns both assets.

Eva Fortea-Verdejo asked if the 27-month mean treatment duration differs for patients on their first recurrence versus subsequent ones, and what is driving the current increase in patient additions.

Answer

CCO Ross Moat and CMO John Paolini clarified that new patient additions are driven by both new and repeat prescribers, with over 85% of use in the 2+ recurrence population. Paolini explained the epidemiology differs: the median disease duration for first-recurrence patients is shorter (around 6 months) compared to multi-recurrence patients (3 years), which naturally influences the average treatment duration for those respective cohorts.

Eva Fortea-Verdejo requested more details on the planned Fall 2025 data update for the casdatifan monotherapy cohorts and asked about the timing and format for learning more about the company's emerging inflammation and immunology (I&I) franchise.

Answer

CEO Terry Rosen clarified the fall update will provide more mature data from the monotherapy cohorts previously presented at ASCO GU. Regarding the I&I pipeline, he indicated that more details would be shared later in the year, potentially at an R&D Day or similar event, highlighting the company's strength in developing small molecules for validated but challenging targets.

Eva Fortea-Verdejo of Wells Fargo Securities asked for clarification on the upcoming overall survival (OS) data from the EDGE-Gastric study, inquiring if the 2025 update will include data from all study arms.

Answer

CMO Dimitry Nuyten confirmed that OS data for the main dom-zim arm (A1) will be presented in 2025. However, he stated it is unlikely that data from other arms will be presented at the same time because they were enrolled sequentially and are maturing on different timelines.

Eva Fortea-Verdejo from Wells Fargo & Company asked for more color on what 'comparable to dupi' means for Th2 biomarkers in healthy volunteers and requested a reminder of what was seen in dupilumab's data.

Answer

CEO Nello Mainolfi referenced published data for dupilumab, noting a TARC reduction around 35% and a minor IgE effect (~5-7%) in the first two weeks. He used these figures to set expectations for KT-621, cautioning that the data can be noisy and not strictly dose-responsive in healthy volunteers.

Eva Fortea-Verdejo, on for Derek, asked how the difference in patient populations between STELLAR-303 (RAS wild-type and mutant) and STELLAR-001 (RAS wild-type only) could impact overall survival outcomes.

Answer

Chief Medical Officer Amy Peterson clarified that STELLAR-001's goal was to show contribution of components, and they observed a benefit with the atezolizumab combination across ORR, PFS, and OS. While encouraged by these results, she noted the read-through to the larger STELLAR-303 trial remains to be seen pending data in the second half of 2025.