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    Dae Ha

    Research Analyst at SVB Leerink

    Dae Ha's questions to Boundless Bio (BOLD) leadership

    Dae Ha's questions to Boundless Bio (BOLD) leadership • Q2 2019

    Question

    Dae Ha from SVB Leerink sought clarification on the AT132 patient numbers for the pivotal cohort versus prior guidance and asked about the clinical trial design for the DMD program, including the potential for a basket trial.

    Answer

    Chairman and CEO Matt Patterson clarified that the 8-patient pivotal expansion cohort for AT132 is a new, separate cohort, bringing the total BLA patient count to 22. For the DMD program, he stated that Audentes will file its own IND in Q1 for its optimized construct and that the company is creatively exploring a basket trial approach for subsequent exon-skipping programs.

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    Dae Ha's questions to Boundless Bio (BOLD) leadership • Q1 2019

    Question

    Dae Ha of SVB Leerink asked for expectations regarding the upcoming World Muscle Society data update for AT132, the timing of regulatory data packages, and the company's strategy for manufacturing scale-up for larger indications.

    Answer

    Matt Patterson, Chairman and CEO, indicated the World Muscle Society update will feature longer-term data and potentially results from new patients. He clarified that the FDA will receive the latest ASGCT data package in the coming weeks to inform discussions on pre-BLA requirements, with a formal update on filing plans expected in Q3. On manufacturing, he noted current capacity meets MTM commercial and pipeline clinical needs, with options to expand significantly within the existing facility or at a second site. No immediate CapEx plans were detailed.

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    Dae Ha's questions to Boundless Bio (BOLD) leadership • Q4 2018

    Question

    Dae Ha from SVB Leerink LLC asked about internal expectations for the upcoming MTM biopsy data, regulatory feedback on clinical endpoints, and plans for scaling manufacturing capacity.

    Answer

    President and CEO Matthew Patterson explained the goal of the higher MTM dose was to get closer to normal protein expression, with a final decision pending biopsy results. He noted that regulators emphasized motor milestone achievement and ventilator reduction. He also confirmed the current 1000L manufacturing scale is sufficient for global MTM commercial demand and ongoing clinical development.

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