Sign in

    Raj Denhoy

    Research Analyst at Jefferies

    Raj Denhoy's questions to MCUR leadership

    Raj Denhoy's questions to MCUR leadership • Q2 2015

    Question

    Raj Denhoy from Jefferies asked about the projected cost for the new manufacturing facility, the associated risks of scaling up production, the timing of commercial investments, the potential for third-party publications, and the current commercial status of CureXcell in Israel.

    Answer

    President & CEO Nissim Mashiach confirmed the manufacturing facility CapEx would be up to $4M in 2015 and $6M-$9M in total, net of incentives. He and CMO Mike Molyneaux clarified that manufacturing risk is low because they are not scaling up batch size, but rather adding capacity via more clean rooms. Commercial planning will accelerate post-data, with senior hires expected by late 2016. Dr. Molyneaux stated no major third-party publications are expected before their own data release. He also explained that CureXcell is not currently being supplied to the Israeli market to avoid any potential issues that could jeopardize the U.S. BLA process.

    Ask Fintool Equity Research AI

    Raj Denhoy's questions to LEAP THERAPEUTICS (LPTX) leadership

    Raj Denhoy's questions to LEAP THERAPEUTICS (LPTX) leadership • Q1 2015

    Question

    Raj Denhoy from Jefferies asked about the company's expectations for CureXcell's reimbursement pathway—whether it would be under a bundled payment or as a separate biologic—and questioned the rationale for choosing a futility analysis over an interim look for the VLU trial.

    Answer

    President and CEO Nissim Mashiach explained that the company expects reimbursement as a biologic due to its unique BLA pathway, but noted its high gross margins provide flexibility. He clarified that the interim look was skipped because rapid patient recruitment made it unnecessary, avoiding study delays and the associated 'alpha penalty'.

    Ask Fintool Equity Research AI