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    Ian Somaiya

    Research Analyst at Nomura Securities

    Ian Somaiya's questions to MCUR leadership

    Ian Somaiya's questions to MCUR leadership • Q2 2015

    Question

    Ian Somaiya from Nomura Securities asked for guidance on interpreting the potential outcomes of the upcoming VLU trial futility analysis, particularly the 'middle zone' (31-45% probability of success), and inquired about the possibility of amending the trial protocol.

    Answer

    President & CEO Nissim Mashiach stated that the company anticipates being in the most favorable zone (46-100%) and that any other outcome would be a disappointment. He explained that the middle zone would still indicate separation between the treatment and control arms, with a chance to meet the endpoint upon full enrollment. CMO Mike Molyneaux added that the middle zone still means the trial is on target. Nissim Mashiach also confirmed the DSMB's role is limited to reporting the probability zone without further detail, as the study remains blinded.

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    Ian Somaiya's questions to MCUR leadership • Q4 2014

    Question

    An analyst on behalf of Ian Somaiya of Nomura Securities asked about the characteristics of the VLU trial recruitment sites, the reasons for accelerated enrollment, the R&D and sales & marketing cost outlook through 2017, and what to expect from the two abstracts being presented at the upcoming SAWC conference.

    Answer

    President & CEO Nissim Mashiach attributed the rapid VLU enrollment to strong clinical team execution and high physician enthusiasm for CureXcell's unique injectable technology. CFO Mark Page projected that 2015 R&D spend would remain elevated and constitute 75-80% of total operating expenses. CMO Mike Molyneaux added that the SAWC abstracts on the MOA study have been well-received, with one accepted for a prestigious oral presentation, highlighting the product's potent angiogenic and cell proliferation capabilities.

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    Ian Somaiya's questions to LEAP THERAPEUTICS (LPTX) leadership

    Ian Somaiya's questions to LEAP THERAPEUTICS (LPTX) leadership • Q1 2015

    Question

    Ian Somaiya of Nomura Securities requested more detail on the VLU futility analysis outcomes, including whether a trial could be stopped early for success, and asked about the status of preliminary discussions with payers.

    Answer

    President and CEO Nissim Mashiach clarified the futility analysis scales and confirmed the trial would not be stopped early for success, as full follow-up is required. He also mentioned that substantial payer discussions will commence after DFU data is available in October. Chief Medical Officer Mark Page added that the company is pursuing a drug-type reimbursement as a biologic.

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