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    Stephen Willey

    Managing Director and Senior Equity Research Analyst at Stifel

    Stephen Willey is a Managing Director and Senior Equity Research Analyst at Stifel, specializing in the biotechnology and healthcare sectors. He covers leading biopharmaceutical companies such as Insmed and Cue Biopharma, and has demonstrated a strong performance background, including notable calls like the 19.8% target price increase for Insmed following regulatory milestones. Willey began his finance career with Thomas Weisel Partners—joining Stifel through its 2010 acquisition—and previously held research roles at ImClone Systems and Mount Sinai School of Medicine. He holds an MBA from New York University, an M.S. from the University of Rhode Island, a B.S. from the University of New Hampshire, and maintains relevant professional securities credentials.

    Stephen Willey's questions to ABEONA THERAPEUTICS (ABEO) leadership

    Stephen Willey's questions to ABEONA THERAPEUTICS (ABEO) leadership • Q1 2025

    Question

    Stephen Willey from Stifel questioned the expected patient throughput at qualified treatment centers (QTCs), both at launch and at steady-state, and asked how the PRV sale impacts the prioritization of the company's early-stage pipeline.

    Answer

    Chief Commercial Officer Dr. Madhav Vasanthavada stated that physicians at potential QTCs are comfortable with a throughput of two patients per month per site, with some institutions indicating capacity for up to four. CEO Dr. Vish Seshadri addressed the pipeline, confirming that the RS1 ophthalmology program remains on track for in-human studies in the second half of 2026, a cadence that fits well with the ZEVASKYN commercial ramp. He noted the PRV proceeds support this without accelerating timelines that are dictated by scientific processes.

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    Stephen Willey's questions to MACROGENICS (MGNX) leadership

    Stephen Willey's questions to MACROGENICS (MGNX) leadership • Q1 2024

    Question

    Asked about screening protocols for pneumonitis and whether dyspnea could be miscategorized. Also requested the median duration of follow-up for the study arms and the distribution of patients based on prior ARPI stability.

    Answer

    The executive confirmed there is no routine pneumonitis screening protocol as it wasn't a prior signal, and the recent cases are under investigation. He did not provide the median follow-up but noted the mean number of doses is now five. The split of patients by prior ARAT exposure duration was approximately 40% to 60%.

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    Stephen Willey's questions to MACROGENICS (MGNX) leadership • Q4 2023

    Question

    Asked about the enrollment kinetics (new vs. experienced sites), whether a go-forward dose has been selected between the 2.7 and 2.0 mg regimens, and if rPFS data maturity would delay the initiation of new expansion cohorts.

    Answer

    Scott Koenig clarified that the rapid enrollment surge in late 2023 was primarily from newly opened sites in Europe. He stated it's too early to decide on a final go-forward dose, as they are waiting for more complete data, and the data safety monitoring committee recommended continuing both doses. The rPFS data maturity will not slow down the initiation of the new expansion cohorts.

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    Stephen Willey's questions to Cue Biopharma (CUE) leadership

    Stephen Willey's questions to Cue Biopharma (CUE) leadership • Q4 2023

    Question

    Inquired about the specifics of the planned CUE-101 Phase II trial, including the second dose being considered, the trigger for the interim analysis, the rationale for a standalone Phase II versus a seamless Phase II/III design, and how recent competitor data influences expectations.

    Answer

    The company is considering 4 mg/kg and likely 2 mg/kg as the two doses for the Phase II trial. The interim analysis will be triggered when 70-80% of patients have completed their cycle 5 scan. A standalone Phase II was chosen as a more cost-effective and confidence-building step before a larger Phase III investment, a decision reinforced by unexpected results in other recent trials. The final analysis of the Phase II, not the interim, would support moving to Phase III.

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    Stephen Willey's questions to Lite Strategy (MEIP) leadership

    Stephen Willey's questions to Lite Strategy (MEIP) leadership • Q4 2023

    Question

    Stephen Willey of Stifel inquired about the expected response rates for venetoclax retreatment in the voruciclib AML trial and whether patients in the ME-344 study would be naive to salvage therapies like LONSURF. He also asked for context on the 20% 4-month PFS threshold for ME-344 and questioned the significant sequential drop in Q4 R&D spending.

    Answer

    President and CEO David Urso indicated that a 20-30% response rate for the voruciclib combination in relapsed/refractory AML would be considered exciting. Chief Medical Officer Dr. Richard Ghalie clarified that ME-344 patients are not required to be naive to LONSURF or regorafenib and that the 20% PFS is a 'floor,' with the data's significance depending on the enrolled patients' prior treatments. CFO Jay File explained the R&D decline was due to the wind-down of the zandelisib trials, which accounted for approximately $26 million of the annual R&D spend.

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    Stephen Willey's questions to Innoviva (INVA) leadership

    Stephen Willey's questions to Innoviva (INVA) leadership • Q2 2017

    Question

    Stephen Willey from Stifel asked for guidance on the continued paydown of the 9% notes, commentary on a citizen petition regarding the closed triple, insights into BREO scripts written with LAMA, and the reason for the timing of the new ANORO DTC campaign.

    Answer

    CFO Eric d'Esparbes confirmed the plan to continue paying down the 2029 notes remains active. CEO Michael Aguiar addressed the closed triple, acknowledging the logic of a competitor's petition but expressing confidence in their filing with the FDA. He estimated that about 40% of the COPD LABA/ICS market involves an 'open triple' combination. Regarding the ANORO DTC campaign, he declined to comment on specific timing decisions but noted its positive launch and expected contribution to growth.

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