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    Joseph Catanzaro • Piper Sandler

    Joseph Catanzaro's questions to Catalyst Pharmaceuticals Inc (CPRX) leadership

    Joseph Catanzaro's questions to Catalyst Pharmaceuticals Inc (CPRX) leadership • Q4 2024

    Question

    Joseph Catanzaro asked for more detail on the 'queuing effect' impacting AGAMREE adoption in the DMD space and what led to the decision to split the salesforce. He also followed up on FYCOMPA, asking if 2025 guidance reflects market resiliency to generics and what efforts will be made to slow erosion.

    Answer

    CCO Jeffrey Del Carmen explained the 'queuing effect' is due to patients being evaluated for other new therapies like ELEVIDYS, which delays changes to their steroid regimen. He expects this to resolve by mid-2025. He also noted the salesforce split allows for a more focused approach in the crowded DMD market and deeper relationship-building for LEMS. CEO Richard Daly addressed FYCOMPA, stating that while the epilepsy market is 'sticky,' the guidance accounts for both price and volume erosion post-patent expiry as they contract with payers and some patients switch to generics, though the decline will be more gradual than typical retail products.

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    Joseph Catanzaro's questions to Revolution Medicines Inc (RVMD) leadership

    Joseph Catanzaro's questions to Revolution Medicines Inc (RVMD) leadership • Q4 2024

    Question

    Joseph Catanzaro of Piper Sandler asked about the design of the frontline PDAC chemo-combination arm, questioning whether it would be continuous therapy or an induction-maintenance approach.

    Answer

    Chief Medical Officer Dr. Wei Lin noted the final design is pending regulatory feedback. CEO Dr. Mark Goldsmith added that a paradigm shift is needed, viewing the combination arm as 'the daraxonrasib arm to which we've added some chemotherapy.' This framing prioritizes the continuous benefit of the targeted therapy, which may not conform to traditional induction-maintenance nomenclature, especially since a separate monotherapy arm will also be included.

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    Joseph Catanzaro's questions to Day One Biopharmaceuticals Inc (DAWN) leadership

    Joseph Catanzaro's questions to Day One Biopharmaceuticals Inc (DAWN) leadership • Q4 2024

    Question

    Joseph Catanzaro asked if promoting second-line OJEMDA use is seen as a near-term benefit by expanding the patient pool or a long-term one via longer treatment duration. He also asked about the gating factors for releasing initial data from the DAY301 program.

    Answer

    Chief Commercial Officer Lauren Merendino described the benefit of earlier use as 'a little of both,' as healthier patients may have improved duration and the patient pool is larger. CEO Jeremy Bender addressed DAY301, stating that the company will wait for a sufficient data set, likely including dose escalation and potentially some dose expansion data, before public disclosure to properly contextualize the development plan.

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    Joseph Catanzaro's questions to Day One Biopharmaceuticals Inc (DAWN) leadership • Q3 2024

    Question

    Joseph Catanzaro of Piper Sandler inquired about the cadence of new patient starts for OJEMDA in Q3, its sustainability, and whether a total prescription (TRx) equates to a one-month supply.

    Answer

    CEO Jeremy Bender confirmed that new patient additions were steady and consistent with the launch quarter, a pattern they expect to continue. CCO Lauren Merendino added that a TRx represents a 28-day supply, with minimal exceptions.

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    Joseph Catanzaro's questions to Exelixis Inc (EXEL) leadership

    Joseph Catanzaro's questions to Exelixis Inc (EXEL) leadership • Q3 2024

    Question

    Joseph Catanzaro asked about the newly clinical XL-495 program, inquiring about the strategy for tumor type selection, biomarker use, and potential cytotoxic combinations.

    Answer

    Chief Scientific Officer Dana Aftab explained that the PM1 inhibitor targets tumors with increased cyclin E levels, driven by biomarkers like CCNE amplification. He noted they are exploring these and other undisclosed biomarkers in the Phase 1 study, as well as evaluating data from preclinical combination studies with cytotoxics and other agents.

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