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    Colleen Kusy • Robert W. Baird & Co.

    Colleen Kusy's questions to Iovance Biotherapeutics Inc (IOVA) leadership

    Colleen Kusy's questions to Iovance Biotherapeutics Inc (IOVA) leadership • Q2 2025

    Question

    Colleen Kusy of Robert W. Baird & Co. asked if the EMA feedback on the melanoma application would affect the regulatory path for non-small cell lung cancer in the U.S. and questioned what specific problems the new specialty pharmacy channel solves for treatment centers.

    Answer

    Interim CEO Frederick Vogt and Chief Regulatory Officer Raj Puri asserted the EMA feedback has no impact on the U.S. regulatory path for NSCLC. CCO Dan Kirby explained the specialty pharmacy channel solves a financial hurdle for hospitals, particularly medium-sized community centers, whose finance departments may be unwilling to purchase high-cost therapies directly.

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    Colleen Kusy's questions to Iovance Biotherapeutics Inc (IOVA) leadership • Q1 2025

    Question

    Colleen Kusy of Baird asked for clarification on whether the out-of-spec rate specifically increased, if this was linked to the annual maintenance, and if the one-month manufacturing disruption will be a recurring annual event.

    Answer

    Chief Operating Officer Igor Bilinsky attributed the transient Q1 issue to new ATC and surgeon learning curves on patient selection and tumor procurement, not the maintenance. He confirmed the maintenance is an annual event but stated its impact will be reduced in future years once the iCTC facility build-out is complete.

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    Colleen Kusy's questions to Iovance Biotherapeutics Inc (IOVA) leadership • Q4 2024

    Question

    Colleen Kusy asked if there was a slowdown in patient infusions during the latter half of Q4 and whether any holiday-related seasonality was observed.

    Answer

    Interim CEO and President Frederick Vogt confirmed there was no holiday-related seasonality. He did note that a planned manufacturing maintenance period occurred, which is a normal event in cell therapy that can cause minor peaks and valleys in launch curves, similar to what has been seen with CAR-T products.

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    Colleen Kusy's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership

    Colleen Kusy's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q2 2025

    Question

    Colleen Kusy from Robert W. Baird & Co. asked about the FDA's view on rescue criteria and how rescued patients are evaluated, and also requested any available color on the feedback from the FDA regarding the DME program.

    Answer

    CEO Jay Duker explained that the FDA allows companies to set their own rescue criteria and that supplemental injections are not considered treatment failures but are handled via sensitivity analyses. Regarding DME, he reported a 'very pleased' outcome from discussions with the agency and confirmed plans to enroll the first patient in the pivotal DME program in 2026, with more details to be shared after receiving written minutes from the FDA.

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    Colleen Kusy's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q4 2024

    Question

    Colleen Kusy asked if EyePoint expects differences in patient types or results between U.S. and ex-U.S. sites, and also inquired about the FDA's non-inferiority margin for DME trials compared to wet AMD.

    Answer

    Chief Medical Officer Ramiro Ribeiro stated that he does not expect significant differences between sites, as wet AMD trials are globally mature and the study was designed to accommodate a global population. He also noted that while subject to FDA discussion, the non-inferiority margin for DME has historically been 4 letters, versus 4.5 for wet AMD.

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    Colleen Kusy's questions to Ocular Therapeutix Inc (OCUL) leadership

    Colleen Kusy's questions to Ocular Therapeutix Inc (OCUL) leadership • Q2 2025

    Question

    Colleen Kusy from Robert W. Baird & Co. questioned if the FDA was consulted on the SOLAR rescue criteria change, confirmed the previous criteria included a 10-letter loss rule, and asked about the impact on the primary endpoint and trial timeline.

    Answer

    Pravin Dugel, Executive Chairman, President & CEO, confirmed the change was a purely strategic decision and not discussed with the FDA, as it has no bearing on the primary endpoint. He also affirmed that the change does not delay the SOLAR trial's timeline, highlighting the study's robust design which includes a lengthy de-risking phase for patient selection.

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    Colleen Kusy's questions to Apellis Pharmaceuticals Inc (APLS) leadership

    Colleen Kusy's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q2 2025

    Question

    Colleen Kusy of Robert W. Baird & Co. asked for an update on the third-party co-pay assistance disruption and about expectations for the VAIL long-term extension study data in differentiating Empaveli for C3G and iCMPGN.

    Answer

    CEO Dr. Cedric Francois stated Apellis supports patient foundations but is independent of their funding. CMO Dr. Caroline Baumal highlighted that the VAIL extension data confirms Empaveli's 'trifecta' of benefits (proteinuria, eGFR, C3 clearance), which continues to differentiate the product and resonate with physicians.

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    Colleen Kusy's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q4 2024

    Question

    Colleen Kusy of Baird asked for the percentage of the market where SYFOVRE has preferred positioning and about the similarity between U.S. and European regulatory reviews for C3G/IC-MPGN.

    Answer

    EVP of Commercial David Acheson noted significant preferred access with plans like Aetna but stated it's hard to give a specific market percentage. CEO Dr. Cedric Francois added that Apellis and its partner Sobi are in 'lockstep' on the global deployment of EMPAVELI for nephrology, highlighting the large opportunity where they will only compete for about 20% of the 5,000 U.S. patients.

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