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    Mark Aleynick • Goldman Sachs

    Mark Aleynick's questions to Allogene Therapeutics Inc (ALLO) leadership

    Mark Aleynick's questions to Allogene Therapeutics Inc (ALLO) leadership • Q2 2025

    Question

    Mark Aleynick, on for Salveen Richter, asked for an update on enrollment progress for the ALPHA-three trial and whether the discontinuation of the FCA (fludarabine, cyclophosphamide, and ALLO-647) arm was affecting patient willingness to enroll.

    Answer

    Zachary Roberts, EVP of R&D and Chief Medical Officer, reported that enrollment momentum continues. While it's too early to quantify the impact of removing the FCA arm, he noted that early feedback from investigators has been positive, as the simplified FC regimen is more familiar and easier to discuss with patients, suggesting a potential positive effect on enrollment.

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    Mark Aleynick's questions to Intellia Therapeutics Inc (NTLA) leadership

    Mark Aleynick's questions to Intellia Therapeutics Inc (NTLA) leadership • Q2 2025

    Question

    On behalf of Salveen Richter at Goldman Sachs, Mark Aleynick asked for Intellia's perspective on the competitive landscape for Nexi, especially given strong results from a competing RNAi therapy, and its commercial positioning.

    Answer

    President and CEO John Leonard positioned Nexi to be a "very formidable competitor" to any agent in the space. He views positive results from others as confirmation of a large, growing, and significantly underdiagnosed market, particularly the wild-type ATTR-CM population, which constitutes about 90% of cases. He expressed confidence in Intellia's ability to compete aggressively for this large patient pool.

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    Mark Aleynick's questions to Amicus Therapeutics Inc (FOLD) leadership

    Mark Aleynick's questions to Amicus Therapeutics Inc (FOLD) leadership • Q2 2025

    Question

    Mark Aleynick of Goldman Sachs asked about the DMX200 program, seeking clarity on the expected timeline for Phase 3 data, the bar for success, and what would be considered a clinically relevant outcome in FSGS.

    Answer

    Chief Development Officer Dr. Jeff Castelli projected that top-line two-year data from the Phase 3 ACTION-3 study would be available in 2027, following expected full enrollment by the end of 2025. He explained the study is powered to show small changes in proteinuria, and that clinical relevance will be demonstrated through responder analyses, specifically the proportion of patients achieving key proteinuria thresholds associated with improved long-term renal outcomes.

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