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    William Pickering • Sanford C. Bernstein & Co.

    William Pickering's questions to Allogene Therapeutics Inc (ALLO) leadership

    William Pickering's questions to Allogene Therapeutics Inc (ALLO) leadership • Q2 2025

    Question

    William Pickering asked for details on the quantitative criteria for the interim analysis, such as minimum event numbers or follow-up duration, and the sensitivity of these criteria to the observed MRD conversion rate.

    Answer

    Zachary Roberts, CMO, responded that the MRD conversion rate they plan to share is not expected to be highly sensitive to those factors. He clarified that the protocol dictates an MRD assessment at a specific time point, and the company will simply analyze and report the binary positive or negative result from that test.

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    William Pickering's questions to Allogene Therapeutics Inc (ALLO) leadership • Q1 2025

    Question

    William Pickering of Sanford C. Bernstein & Co. asked for more color on the conversion rate from patient consent to randomization in the ALPHA3 trial and what factors might cause patients not to convert.

    Answer

    Dr. Zachary Roberts, EVP of R&D and CMO, responded that patient uptake is very good when the trial is introduced early in the treatment process. He noted that the vast majority of MRD-positive patients agree to proceed to the main study and that screen failure rates are low, as these are healthier, frontline patients. He emphasized that more detailed metrics will be shared later.

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    William Pickering's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership

    William Pickering's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership • Q3 2025

    Question

    William Pickering questioned an apparent change in the maximum dose for the ARO-DM1 program, from a previously mentioned 12 mg/kg to a current protocol of 6 mg/kg.

    Answer

    CEO Christopher Anzalone provided a direct clarification, stating, 'We still can go up to twelve mgs per kg in the current study, the DM1 study.'

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    William Pickering's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership • Q3 2024

    Question

    William Pickering asked for color on the ~$50 million sequential increase in R&D spending this quarter and for expectations on the R&D expense line over the next few quarters.

    Answer

    CFO Ken Myszkowski attributed the R&D increase to the company's pipeline candidates advancing into later, more costly stages of development. He anticipates that R&D expenses will continue to increase into next year and noted that more specific guidance will be provided on the next earnings call following the completion of the budgeting process.

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    William Pickering's questions to Vertex Pharmaceuticals Inc (VRTX) leadership

    William Pickering's questions to Vertex Pharmaceuticals Inc (VRTX) leadership • Q2 2025

    Question

    William Pickering of Bernstein questioned why Gernavix was not included in the draft rule for the NOPAIN Act and asked about the current cycle time for Casgevy treatment, from cell collection to infusion.

    Answer

    President and CEO Dr. Reshma Kewalramani explained the NOPAIN Act draft contained a misunderstanding about Gernavix's indication for postsurgical pain, which she expects to be resolved. She noted the Casgevy cycle time is roughly 4-5 months, with plans in place to improve it as the launch momentum accelerates.

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    William Pickering's questions to Vertex Pharmaceuticals Inc (VRTX) leadership • Q4 2024

    Question

    William Pickering inquired about the specific assumptions for the placebo effect used in designing the Phase III study for suzetrigine in DPN and asked what magnitude of delta versus placebo would be considered clinically meaningful.

    Answer

    CEO Reshma Kewalramani explained that the Phase III trial design, which includes both placebo and active comparator (gabapentin) arms, was informed by extensive historical data from numerous DPN studies. She confirmed the study is appropriately powered to account for the known range of placebo effects seen in the literature.

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    William Pickering's questions to Intellia Therapeutics Inc (NTLA) leadership

    William Pickering's questions to Intellia Therapeutics Inc (NTLA) leadership • Q1 2025

    Question

    William Pickering asked about enrollment rate expectations for the MAGNITUDE-2 study in ATTR polyneuropathy (PN) and whether competitor studies are reasonable benchmarks, given the evolving treatment landscape.

    Answer

    Chief Medical Officer David Lebwohl explained that while the trial must enroll in countries where modern therapies like Vutrisiran are not yet available, this has led to very high investigator interest. He expects brisk enrollment through 2026, enabling a potential BLA submission in 2028. He also noted the trial could stop early based on an interim analysis due to the high efficacy seen in PN.

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    William Pickering's questions to Intellia Therapeutics Inc (NTLA) leadership • Q4 2024

    Question

    William Pickering asked about the long-term observation period in the HAE Phase III trial, its importance for demonstrating a functional cure, and how long the company would wait before submitting a supplemental filing with that data.

    Answer

    CMO David Lebwohl acknowledged that the full 104-week data would not be available at the initial BLA filing. However, he noted they would be close to having the full data set by the time of approval and would consider filing a supplemental BLA 'fairly soon after the initial approval' to include it.

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    William Pickering's questions to Intellia Therapeutics Inc (NTLA) leadership • Q3 2024

    Question

    William Pickering asked if there are plans to expand the AATD program study beyond the initial New Zealand site and whether it is reasonable to expect initial data in 2025.

    Answer

    CMO David Lebwohl confirmed that other trial sites will be added and listed on clinicaltrials.gov as they become active. He also stated that it is 'reasonable to think we have data in 2025.'

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    William Pickering's questions to Regeneron Pharmaceuticals Inc (REGN) leadership

    William Pickering's questions to Regeneron Pharmaceuticals Inc (REGN) leadership • Q1 2025

    Question

    William Pickering of AllianceBernstein inquired about the EYLEA HD monthly dosing submission, asking about the amount of safety data included from the recently completed trial and whether the FDA was aligned on its sufficiency.

    Answer

    President and CEO Dr. Leonard Schleifer declined to provide specific enrollment data but emphasized that the FDA's acceptance of the submission for review signifies that it met the threshold for sufficiency. He stated the focus is now on the agency's review process.

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    William Pickering's questions to Regeneron Pharmaceuticals Inc (REGN) leadership • Q4 2024

    Question

    William Pickering of AllianceBernstein asked about the company's complement programs, specifically how the antibody-siRNA combo might fit into the Myasthenia Gravis (MG) and Geographic Atrophy (GA) treatment landscapes.

    Answer

    President and CSO, Dr. George Yancopoulos, explained the combo's efficacy benefit is in driving more patients' LDH levels to the normal range, with a safety profile consistent with the class. For GA, he positioned their systemic approach as an alternative to intravitreal treatments, allowing physicians to weigh the different risk profiles of class-specific infections versus potential immediate vision loss.

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    William Pickering's questions to Regeneron Pharmaceuticals Inc (REGN) leadership • Q3 2024

    Question

    William Pickering of Bernstein asked if the biosimilar erosion curve for Lucentis is a good proxy for EYLEA and what key commercial differences should be considered.

    Answer

    EVP of Commercial Marion McCourt stated it was too early to comment on erosion for a product not yet used in the real world. President and CSO Dr. George Yancopoulos added a key difference: unlike with Lucentis, EYLEA patients have the option to switch to a differentiated, superior product in EYLEA HD, not just a biosimilar, creating a very different market dynamic.

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