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    Lisa Walter • RBC Capital Markets

    Lisa Walter's questions to Regenxbio Inc (RGNX) leadership

    Lisa Walter's questions to Regenxbio Inc (RGNX) leadership • Q2 2025

    Question

    Lisa Walter, on for Luca Ici, asked about the regulatory path for Suravec in diabetic retinopathy, sought clarification on the treatment needs of patients who did not achieve a two-step DRSS improvement, and inquired about the enrollment status of the subretinal wet AMD pivotal study.

    Answer

    President & CEO Curran Simpson stated that enrollment for the subretinal wet AMD studies is "imminent." CMO Dr. Steve Pakola clarified that the regulatory plan for diabetic retinopathy involves two adequate and well-controlled studies, with the new Phase 2b/3 trial intended to be one of them. He also noted that only a minority of patients in the dose level 3 group required any supplemental injections, not the full 50% who didn't meet the primary endpoint without them.

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    Lisa Walter's questions to Regenxbio Inc (RGNX) leadership • Q4 2024

    Question

    Lisa Walter, representing Luca Issi from RBC Capital Markets, asked if the AFFINITY study for DMD measures cardiac endpoints like LVEF and troponin, and if these could differentiate the program. She also questioned whether REGENXBIO would consider shortening enrollment in the subretinal wet AMD pivotal study to accelerate timelines in a competitive market.

    Answer

    CEO Curran Simpson noted that preclinical data suggests good cardiac biodistribution but clinical benefits are a longer-term outcome. Chief Medical Officer Dr. Steve Pakola confirmed they measure cardiac endpoints but expect meaningful changes to occur over a longer period in older patients. Regarding the wet AMD trial, Dr. Pakola stated firmly that neither REGENXBIO nor AbbVie would cut enrollment short, emphasizing the importance of fully characterizing safety and efficacy for a global launch and positioning their therapy as a paradigm shift, not an incremental improvement.

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    Lisa Walter's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership

    Lisa Walter's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q2 2025

    Question

    Lisa Walter of RBC Capital Markets inquired if any updates beyond safety, such as patient retention, should be expected before the pivotal trial readouts and if the company plans to run an open-label extension study.

    Answer

    CEO Jay Duker confirmed that the company will conduct an open-label extension study, which is currently in the planning stages. For interim updates, he expects to provide basic demographics of the enrolled population and periodic safety updates, but reiterated the desire to avoid introducing bias by disclosing too much information, a point echoed by CMO Ramiro Ribeiro.

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    Lisa Walter's questions to Ocular Therapeutix Inc (OCUL) leadership

    Lisa Walter's questions to Ocular Therapeutix Inc (OCUL) leadership • Q2 2025

    Question

    Lisa Walter from RBC Capital Markets sought clarification on the trial protocol, asking whether a rescue due to hemorrhage is considered an on-protocol or off-protocol event.

    Answer

    Pravin Dugel, Executive Chairman, President & CEO, explained that while physicians always retain discretion to rescue a patient for safety, the SOUL-one protocol explicitly defines on-protocol rescue as either a 15-letter loss of vision or a hemorrhage that threatens the macula. He emphasized that the vast majority of rescues have been based on the 15-letter loss criterion, indicating strong protocol adherence.

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    Lisa Walter's questions to Apellis Pharmaceuticals Inc (APLS) leadership

    Lisa Walter's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q2 2025

    Question

    Lisa Walter from RBC Capital Markets asked for details on the path for Empaveli to achieve blockbuster status and whether that potential relies on further label expansions beyond the current indications.

    Answer

    CEO Dr. Cedric Francois outlined the path, noting the ~5,000 patients in the newly approved C3G/IC-MPGN indications. He stated that every 1,000 patients treated could represent about $500 million in revenue, suggesting blockbuster potential is achievable with the current label alone. Future indications like FSGS and DGF would be additive to this.

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    Lisa Walter's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q1 2025

    Question

    Lisa Walter asked if Apellis would consider exploring EMPAVELI in other kidney indications like IgAN, given recent data from a competitor, and requested an update on ex-U.S. launch plans for SYFOVRE.

    Answer

    Executive Cedric Francois stated that after a thorough analysis, Apellis has prioritized initiating two new Phase III trials for EMPAVELI in delayed graft function and focal segmental glomerulosclerosis, and that IgAN is not one of its next target indications. Regarding SYFOVRE ex-U.S., he noted it is early in the Australian launch but enthusiasm is high. He affirmed the company continues to work with regulators in other regions, leveraging growing long-term data to secure the best possible global access.

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    Lisa Walter's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q3 2024

    Question

    Lisa Walter of RBC Capital Markets asked about the outlook for SYFOVRE approval in other ex-U.S. geographies like the UK, Australia, and Canada following the negative CHMP opinion, and if other large foreign markets were being targeted.

    Answer

    COO Adam Townsend confirmed that Apellis is continuing to pursue regulatory approval in the UK, Switzerland, Canada, and Australia, as these processes are independent of the EMA. He also mentioned they are moving forward in markets that accept the U.S. file, such as Brazil, and are using distributors to access other smaller markets, underscoring the large unmet need for GA treatment outside the U.S.

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    Lisa Walter's questions to WAVE Life Sciences Ltd (WVE) leadership

    Lisa Walter's questions to WAVE Life Sciences Ltd (WVE) leadership • Q1 2025

    Question

    Lisa Walter from RBC Capital Markets inquired about the requirements to initiate a Phase II study for the A1AT program, including the target serum level, and questioned the potential regulatory path, including whether a head-to-head trial might be necessary.

    Answer

    President and CEO Dr. Paul Bolno responded that the current study will inform the Phase II design by defining the achievable dynamic range of M protein levels and establishing durability to set a dosing frequency. Regarding the regulatory path, he believes an accelerated pathway based on restoring healthy protein levels is a distinct and viable approach compared to IV protein replacement. He also highlighted the long-term strategy of pursuing both liver and lung endpoints to treat the complete AATD disease profile, a plan being developed with their partner.

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    Lisa Walter's questions to WAVE Life Sciences Ltd (WVE) leadership • Q4 2024

    Question

    Lisa Walter from RBC Capital Markets questioned the dosing strategy for Wave's RNA editing platform, asking for context on its higher doses (e.g., 400mg for WVE-006) compared to lower doses used in DNA editing and siRNA therapies, and inquired about potential safety risks.

    Answer

    President and CEO Paul Bolno explained that direct dose comparisons are complex and that Wave's absolute dosing is within the range of other approved drugs like Inclisiran. He emphasized that as a leader in ADAR editing, exploring a wide dose range is crucial to understand the kinetics and optimize both efficacy and durability. He reassured that extensive safety data from healthy volunteer studies support the exploration of these higher doses.

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