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    Ed Arce • H.C. Wainwright & Co.

    Ed Arce's questions to Aurinia Pharmaceuticals Inc (AUPH) leadership

    Ed Arce's questions to Aurinia Pharmaceuticals Inc (AUPH) leadership • Q4 2024

    Question

    Ed Arce asked for perspective on the impact of new ACR treatment guidelines on rheumatologist prescribing habits for LUPKYNIS. He also inquired about the long-term development timeline for AUR200, including indication selection and the move to Phase II.

    Answer

    President and CEO Peter Greenleaf highlighted that the ACR guidelines encourage earlier diagnosis and longer treatment durations, which are beneficial for the market and LUPKYNIS. He noted that over 50% of prescriptions already come from rheumatologists and expects the guidelines' impact to grow over time. For AUR200, he reiterated that the company will provide more details on future plans after analyzing the upcoming SAD data.

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    Ed Arce's questions to Travere Therapeutics Inc (TVTX) leadership

    Ed Arce's questions to Travere Therapeutics Inc (TVTX) leadership • Q4 2024

    Question

    Ed Arce asked about potential ADCOM questions for FSGS based on the PARASOL findings, specific pre-commercial activities to ensure rapid uptake, and the expected incremental SG&A investment for the launch.

    Answer

    CEO Eric Dube stated that SG&A for the FSGS launch would be incremental as the core infrastructure is already in place. He emphasized that the high unmet need in FSGS will be a key driver of adoption. CMO Dr. Jula Inrig added that a potential ADCOM would focus on educating stakeholders on the clinical meaningfulness of proteinuria reduction and the overall benefit-risk profile of sparsentan in FSGS.

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    Ed Arce's questions to Ultragenyx Pharmaceutical Inc (RARE) leadership

    Ed Arce's questions to Ultragenyx Pharmaceutical Inc (RARE) leadership • Q4 2024

    Question

    An analyst on behalf of Ed Arce asked how the Phase II/III Aurora study for GTX-102 will differ from the Aspire study and if its data will support the BLA filing.

    Answer

    CEO Emil Kakkis explained that the main Aspire study focuses on deletion patients aged 4-17. The Aurora study is supportive, designed to expand the label to other genotypes and age groups (under 4 and older). The company intends to have a cut of data from Aurora available at the time of the BLA filing to support a broader label.

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    Ed Arce's questions to Arbutus Biopharma Corp (ABUS) leadership

    Ed Arce's questions to Arbutus Biopharma Corp (ABUS) leadership • Q1 2024

    Question

    On behalf of Ed Arce, Thomas asked if the next pivotal study for imdusiran would evaluate it as a monotherapy or in combination, questioned the rationale for the different durvalumab dosing intervals in the new Phase IIa trial, and inquired about the next steps for the AB-101 program.

    Answer

    Interim President and CEO Michael McElhaugh confirmed that the next study will be a combination therapy to address the three pillars of an HBV cure. Chief Medical Officer Dr. Karen Sims detailed that the durvalumab trial's varied dosing aims to find an optimal balance between immunomodulatory effects and safety. She also clarified that the AB-101 Phase I study will move into dosing HBV patients in its third part, after which the goal is to initiate a Phase II combination study with imdusiran.

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