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    Samantha Semenkow • Citigroup

    Samantha Semenkow's questions to Allogene Therapeutics Inc (ALLO) leadership

    Samantha Semenkow's questions to Allogene Therapeutics Inc (ALLO) leadership • Q2 2025

    Question

    Samantha Semenkow asked about the status of the protocol amendment to close the FCA arm, whether enrollment could continue during this process, and if patients screened in the interim would remain eligible for the study.

    Answer

    Zachary Roberts, CMO, confirmed that the protocol amendment is with IRBs and expected to be approved within days, causing minimal to no disruption. He assured that patients being screened for MRD during this period will remain eligible to enroll in the FC arm once the amendment is approved.

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    Samantha Semenkow's questions to Allogene Therapeutics Inc (ALLO) leadership • Q1 2025

    Question

    Samantha Semenkow from Citigroup asked about the ALLO-329 autoimmune trial, inquiring about the data set size needed for a decision on the lymphodepletion regimen and the potential for similar site staffing challenges seen in ALPHA3.

    Answer

    President and CEO Dr. David Chang acknowledged that they are proactively addressing potential site staffing issues for the RESOLUTION study, noting the added complexity of coordinating between cell therapists and rheumatologists. He stated the initial data would come from a "handful of patients" and that the study is designed to test both lymphodepletion regimens (with and without) concurrently, rather than to select one at this stage.

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    Samantha Semenkow's questions to Allogene Therapeutics Inc (ALLO) leadership • Q4 2024

    Question

    Samantha Semenkow asked about the expansion of autologous CAR T infrastructure into community oncology centers, and how Allogene views its ability to leverage this build-out for a potential cema-cel launch.

    Answer

    President and CEO Dr. David Chang framed this trend as a positive for the entire field and especially favorable for Allogene. He stated that the logistical simplicity, scalability, and off-the-shelf nature of allogeneic CAR T are well-suited for the community setting, so the infrastructure being built by others will ultimately benefit Allogene's potential launch.

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    Samantha Semenkow's questions to Catalyst Pharmaceuticals Inc (CPRX) leadership

    Samantha Semenkow's questions to Catalyst Pharmaceuticals Inc (CPRX) leadership • Q2 2025

    Question

    Samantha Semenkow asked about Catalyst's strategy for educating oncologists on the LEMS opportunity for Firdapse, the metrics used to track the campaign's success, the expected timeline for oncology to become a larger revenue segment, and plans to leverage data from the Phase 1 DMD switching study for Agamry.

    Answer

    EVP & Chief Commercial Officer Jeff Del Carmen detailed a three-step oncology strategy involving frictionless VGCC antibody testing, leveraging new NCCN guidelines, and establishing care pathways in oncology practices. He noted success will be tracked by increased testing from oncologists, with a meaningful revenue impact expected in 2026 and beyond. Chief Medical Officer Dr. Will Andrews added that the Agamry switching study is exploratory, with data expected in late 2025 to early 2026 to inform potential future studies.

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    Samantha Semenkow's questions to Catalyst Pharmaceuticals Inc (CPRX) leadership • Q3 2024

    Question

    Samantha Semenkow asked about early trends in AGAMREE's patient durability, the stability of the patient switch mix from EMFLAZA and prednisone, and the specific drivers behind the observed 15% discontinuation rate.

    Answer

    CCO Jeffrey Del Carmen reported a strong and stable discontinuation rate for AGAMREE of around 15%, which aligns with forecasts. He noted the patient switch mix (45% from EMFLAZA, 43% from prednisone) is also stable and expected to continue. Del Carmen clarified that discontinuations are often temporary pauses as patients evaluate new treatments like gene therapy, rather than being driven by efficacy or side effect concerns, and that patients are expected to return to AGAMREE.

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    Samantha Semenkow's questions to argenx SE (ARGX) leadership

    Samantha Semenkow's questions to argenx SE (ARGX) leadership • Q2 2025

    Question

    Samantha Semenkow from Citigroup asked about the rationale for advancing ARGX-119 into clinical development and whether the early data from the CMS study increases enthusiasm for its potential in larger indications like ALS and SMA, and what the overall market opportunity is.

    Answer

    CMO Luc Truyen explained that the CMS study was chosen to get the best 'proof of biology' for the agonistic MuSK antibody, which was successfully observed via functional improvements. CEO Tim Van Hauwermeiren added that while there is read-through potential, ALS and SMA are biologically different. He positioned ARGX-119 as a 'pipeline in a product' with exciting potential in nerve regeneration and muscle diseases beyond the current three indications.

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    Samantha Semenkow's questions to argenx SE (ARGX) leadership • Q1 2025

    Question

    Samantha Semenkow asked how the discontinuation rate in CIDP has trended and whether physicians are still commonly giving patients a 12-week trial period.

    Answer

    Chief Operating Officer Karen Massey confirmed that physicians are still largely using a 12-week trial period. She noted that as the launch has matured, the discontinuation rate has seen a slight uptick, moving closer to what was expected based on the ADHERE trial data. However, she emphasized that the rate remains below that level, indicating that patients are having a positive experience and staying on therapy.

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    Samantha Semenkow's questions to argenx SE (ARGX) leadership • Q4 2024

    Question

    Samantha Semenkow asked about the company's confidence in the FDA granting self-administration for the prefilled syringe (PFS) and how previous FDA concerns about the administration process factored into their strategy.

    Answer

    CEO Tim Van Hauwermeiren expressed confidence, stating that argenx submitted a 'very strong data set,' including a solid human factor study. He noted that based on the nature of questions from the FDA, the review appears to be on track for the April 10 PDUFA date, and the company is collaborating fully with the agency.

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    Samantha Semenkow's questions to argenx SE (ARGX) leadership • Q1 2024

    Question

    Samantha Semenkow asked if the highlighted growth in VYVGART Hytrulo was a recent acceleration and whether the prefilled syringe (PFS) is expected to have a similar or sharper uptake trajectory.

    Answer

    COO Karen Massey confirmed that Hytrulo uptake accelerated in Q1, driven by the establishment of payer policies and a J-code. She anticipates the PFS will be another significant growth engine, viewing it as a key advancement that will help move VYVGART into earlier lines of treatment and further expand the prescriber base.

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    Samantha Semenkow's questions to WAVE Life Sciences Ltd (WVE) leadership

    Samantha Semenkow's questions to WAVE Life Sciences Ltd (WVE) leadership • Q2 2025

    Question

    Samantha Semenkow from Citi inquired about the WVE-007 program, asking how the Activin E reduction in cohort one compared to preclinical models and about the expected correlation between knockdown and weight loss. For the AATD program, she asked about the target Z-to-M protein conversion rate.

    Answer

    President & CEO Paul Bolno explained that WVE-007 showed a dose response in preclinical models and that cohort one data demonstrated good consistency with their PK/PD modeling, which is why they expanded cohort two. For the AATD program (WVE-006), he stated the goal has always been to convert ZZ patients to an MZ phenotype, which they surpassed in the single-dose data. He noted that while they expect more protein with multi-dosing, achieving a 50% correction to the MZ level is the key therapeutic goal.

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    Samantha Semenkow's questions to Beam Therapeutics Inc (BEAM) leadership

    Samantha Semenkow's questions to Beam Therapeutics Inc (BEAM) leadership • Q3 2024

    Question

    Samantha Semenkow of Citigroup asked about the potential efficacy versus safety trade-off for the ESCAPE program and any safety concerns related to its anti-CD117 antibody component, BEAM-103.

    Answer

    CEO John Evans stated that current data suggests ESCAPE can achieve full efficacy, mitigating concerns of a trade-off. President Dr. Giuseppe Ciaramella added that other anti-CD117 antibodies have shown a favorable safety profile with only mild, transient neutropenia, supporting the potential for an outpatient treatment paradigm.

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    Samantha Semenkow's questions to Beam Therapeutics Inc (BEAM) leadership • Q3 2024

    Question

    Samantha Semenkow from Citigroup asked about the potential efficacy trade-off for ESCAPE's improved safety profile and inquired about any safety concerns with the BEAM-103 (anti-CD117) antibody.

    Answer

    CEO John Evans stated that initial NHP data for ESCAPE shows 'fairly full efficacy,' suggesting a compelling profile without a trade-off. President Dr. Giuseppe Ciaramella added that other anti-CD117 antibodies have shown only mild, transient neutropenia, supporting a favorable safety profile and the potential for an outpatient procedure. A healthy volunteer study will further define the PK/PD profile.

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