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    Stephen Willey's questions to Zymeworks Inc (ZYME) leadership

    Stephen Willey's questions to Zymeworks Inc (ZYME) leadership • Q2 2025

    Question

    Stephen Willey from Stifel asked for Zymeworks' perspective on the clinical data for pasaritamab, a partnered asset with J&J, noting its favorable tolerability but lower PSA50 rates compared to other PSMA-targeting bispecifics, and questioned what drives the molecule's unique profile.

    Answer

    Chief Scientific Officer Paul Moore attributed the molecule's excellent tolerability to the novel KLK2 target, which provides a superior therapeutic window. He suggested this profile makes the drug a strong candidate for combination therapies to boost efficacy, a strategy J&J is actively exploring. He also noted that CD3 binder affinity is tailored to each specific target.

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    Stephen Willey's questions to Zymeworks Inc (ZYME) leadership • Q1 2025

    Question

    Stephen Willey from Stifel asked for guidance on the timing of data release for ZW171 and ZW191, questioning if interim updates would be provided. He also inquired whether the company's clinical development capacity could be expanded following potential milestone payments from the zanidatamab program.

    Answer

    CEO Kenneth Galbraith stated that it is too early to provide specific data timing for ZW171 and ZW191, reiterating that updates will come via abstracts at peer-reviewed conferences. He expressed satisfaction with the current clinical operations infrastructure, which he believes is efficient and sufficient to advance the current pipeline, including the upcoming ZW251 trial, without needing immediate expansion upon receipt of milestone payments.

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    Stephen Willey's questions to Zymeworks Inc (ZYME) leadership • Q4 2024

    Question

    Stephen Willey inquired about the clinical development strategy for ZW251, specifically the potential for accelerated combination cohorts, and the rationale for prioritizing it over the IND-ready ZW220 (NaPi2b).

    Answer

    Chair and CEO Kenneth Galbraith confirmed a portfolio-wide strategy to explore combinations early to achieve durable responses, especially for ZW251 in HCC. He stated the prioritization of ZW251 was driven by excitement for the asset and the ability to accelerate its clinical timeline, not by any negative developments for ZW220, which remains a high-interest, differentiated ADC.

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    Stephen Willey's questions to Zymeworks Inc (ZYME) leadership • Q3 2024

    Question

    Stephen Willey inquired about the dose optimization strategy for the ZW171 and ZW191 Phase I trials and how the preclinical therapeutic index of the company's ADCs informs its combination therapy strategy.

    Answer

    CEO Kenneth Galbraith explained that they will likely explore multiple doses in expansion cohorts to ensure a clear understanding of tolerability and optimal dosing, avoiding premature acceleration. Chief Scientific Officer Dr. Paul Moore added that combination strategies are being considered for all three ADC programs to move into earlier lines of therapy, with partners chosen based on the specific disease indication.

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    Stephen Willey's questions to Insmed Inc (INSM) leadership

    Stephen Willey's questions to Insmed Inc (INSM) leadership • Q2 2025

    Question

    Stephen Willey asked about the planned registrational development for TPIP in PAH, wondering if it would be a single Phase 3 trial or a broader program similar to sotatercept, targeting different patient subgroups.

    Answer

    CEO William Lewis stated that plans would be clearer after their October FDA meeting but noted that enthusiasm for the program has grown significantly. He emphasized TPIP's potential across PAH, PH-ILD, and possibly IPF. CMO Martina Flammer added that the trial design will account for sotatercept's presence on the market, but TPIP's strong Phase 2 data provides high confidence in its competitive profile.

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    Stephen Willey's questions to Insmed Inc (INSM) leadership • Q4 2024

    Question

    Stephen Willey asked about the percentage of Phase II PAH patients who entered the open-label extension (OLE) for TPIP and whether any OLE data would be shared at the upcoming readout.

    Answer

    CMO Martina Flammer stated that the 'vast majority' of patients continued into the OLE, with many titrating to higher doses up to 1,280 micrograms. CEO Will Lewis confirmed that OLE data will not be available with the main trial readout. However, he noted that the Phase III study is intended to use the higher 1,280 microgram maximum tolerated dose, suggesting the Phase II results may underrepresent the drug's full potential.

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    Stephen Willey's questions to Insmed Inc (INSM) leadership • Q3 2024

    Question

    Stephen Willey from Stifel inquired about the nature of the upcoming Phase II PAH data disclosure and the hierarchical importance of the trial's endpoints, such as PVR reduction versus 6-minute walk distance.

    Answer

    CEO Will Lewis highlighted that a significant reduction in PVR, which is not common in PAH, would be very encouraging, and noted that other markers like NT-proBNP have also shown positive directional trends on a blinded basis. CMO Martina Flammer confirmed that PVR reduction is the primary endpoint for the Phase II study, which is standard for this stage, and that the trial will also assess 6-minute walk, PK, clinical worsening, and quality of life.

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    Stephen Willey's questions to Insmed Inc (INSM) leadership • Q3 2024

    Question

    Stephen Willey asked about the upcoming Phase II PAH data disclosure and the hierarchical importance of endpoints like PVR reduction and 6-minute walk distance, given the small study size.

    Answer

    CEO Will Lewis noted that seeing a significant reduction in PVR, which is not common in PAH, would be very encouraging, and that other markers like NT-proBNP have been directionally positive on a blinded basis. CMO Martina Flammer confirmed that PVR reduction is the primary endpoint for the Phase II study, which is standard for assessing hemodynamics at this stage, with other key measures including 6-minute walk and clinical worsening.

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    Stephen Willey's questions to OmniAb Inc (OABI) leadership

    Stephen Willey's questions to OmniAb Inc (OABI) leadership • Q2 2025

    Question

    Stephen Willey from Stifel Institutional asked about the economic structure of the Janssen trispecific deal, the potential recurring revenue from the Exploration platform, and the proportion of preclinical assets derived from the OmniChicken platform.

    Answer

    CEO Matthew Foehr clarified the Janssen program is not fully prepaid and includes a $35 million milestone upon first sales. CFO Kurt Gustafson stated that while they have estimates for Exploration's recurring revenue, they are not disclosing them yet. Mr. Foehr added that OmniChicken-derived programs are present in the preclinical pipeline but did not provide a specific breakdown, noting the portfolio's overall average royalty rate has increased.

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    Stephen Willey's questions to OmniAb Inc (OABI) leadership • Q1 2025

    Question

    Speaking on behalf of Stephen Willey, an analyst named Julian asked if there were any observable trends among partners interested in the exploration platform regarding therapeutic targets, indications, or company size. He also asked if the program could be extended to new, future partners.

    Answer

    Matthew Foehr, President and CEO, confirmed that new partners will have access to purchase the exploration platform as they sign on. Regarding trends, he noted that while specific targets are confidential, the company sees broad interest driven by its technology launches, such as increased activity in CNS, infectious disease, and multi-specifics following the OmniAb launch, in addition to consistent interest in oncology and immunology.

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    Stephen Willey's questions to OmniAb Inc (OABI) leadership • Q4 2024

    Question

    On behalf of Stephen Willey from Stifel, a question was asked about the representation of different platforms within the preclinical discovery programs and the downstream economics for sugemalimab, including its inclusion in the 2025 guidance.

    Answer

    President and CEO Matthew Foehr stated the preclinical portfolio is diverse, with a mix of programs from OmniRodent, bispecific, and chicken-based technologies. CFO Kurt Gustafson confirmed the royalty rate for sugemalimab is 3% globally and clarified that while the 2025 revenue guidance includes all revenue streams, it does not bake in significant upside from these specific royalties due to limited sales visibility.

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    Stephen Willey's questions to OmniAb Inc (OABI) leadership • Q3 2024

    Question

    Stephen Willey asked for insight into the proportion of new program starts that are multi-specific in nature, the types of targets being pursued, and an update on the blended royalty rate of the portfolio, particularly concerning the Immunovant 1402 asset.

    Answer

    CEO Matt Foehr confirmed a growing interest and increase in multi-specific programs, driven by technologies like OmniAb, but did not provide a specific percentage. CFO Kurt Gustafson stated he had no update to the previously disclosed blended royalty rate but noted it was unlikely to have changed significantly. He clarified the Immunovant deal structure is via a third party (Henal) but confirmed the effective royalty rate to OmniAb is consistent with their standard low-to-mid-single-digit range.

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    Stephen Willey's questions to Incyte Corp (INCY) leadership

    Stephen Willey's questions to Incyte Corp (INCY) leadership • Q2 2025

    Question

    Stephen Willey of Stifel asked about the baseline characteristics of the myelofibrosis (MF) patients enrolled in the Phase 1 study of 989 and the expected duration of follow-up for the upcoming data release.

    Answer

    President and Head of R&D Pablo Cagnoni described the patient population as 'typical' for those who have been exposed to Jakafi (intolerant or progressed), with no overly restrictive enrollment criteria. He noted that follow-up will be variable, but some patients from early dose cohorts will have been followed for more than a year.

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    Stephen Willey's questions to Exelixis Inc (EXEL) leadership

    Stephen Willey's questions to Exelixis Inc (EXEL) leadership • Q2 2025

    Question

    Stephen Willey of Stifel requested clarification on the decision-making process for halting the STELLAR-305 trial, asking about the timing of the competitive assessment relative to the unblinding of the data.

    Answer

    EVP & CMO Amy Peterson confirmed the trial had a pre-planned gate for review and that the company reviewed the unblinded data. The decision to halt was made to prioritize other indications and reallocate resources, though she noted a future path in head and neck is not entirely ruled out.

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    Stephen Willey's questions to Exelixis Inc (EXEL) leadership • Q4 2024

    Question

    Stephen Willey asked for details on the STELLAR-303 trial design, specifically the expected distribution of RAS wild-type versus mutant patients and whether the primary endpoint had changed.

    Answer

    Chief Medical Officer Amy Peterson clarified that the primary endpoint was modified to focus on patients without liver metastases, a stronger prognostic factor than RAS status. President and CEO Michael Morrissey added that data from Merck's LEAP-17 trial, which showed a better hazard ratio in RAS mutants, supported this strategic shift away from a RAS-focused endpoint.

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    Stephen Willey's questions to Exelixis Inc (EXEL) leadership • Q3 2024

    Question

    Stephen Willey asked for clarification on the STELLAR-305 study, questioning if the Phase 2 portion has formally transitioned to Phase 3 and if the metrics for that decision would be disclosed.

    Answer

    Chief Medical Officer Amy Peterson confirmed that STELLAR-305 is a Phase 2/3 study that is still enrolling. She stated that data from the trial will be disclosed once it is mature.

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    Stephen Willey's questions to X4 Pharmaceuticals Inc (XFOR) leadership

    Stephen Willey's questions to X4 Pharmaceuticals Inc (XFOR) leadership • Q1 2025

    Question

    Stephen Willey of Stifel inquired about commercial performance, specifically patient persistency and compliance for XOLREMDI in WHIM syndrome, the typical prescription supply duration, and the assumed patient dropout rate for the 4WARD trial.

    Answer

    Executive Mark Baldry stated that patient compliance and adherence rates are higher than typical for a daily oral medication and that patients currently receive a one-month supply. CEO Paula Ragan added that the 4WARD trial's target of 150 enrolled patients already accounts for potential dropouts and that based on current data, the trial remains on track for full enrollment in Q3 or Q4 2025.

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    Stephen Willey's questions to X4 Pharmaceuticals Inc (XFOR) leadership • Q4 2024

    Question

    Stephen Willey from Stifel asked for details on the regulatory discussions that led to tightening the 4WARD trial's ANC threshold, whether this change could slow enrollment, and for an update on distributor inventory levels and early gross-to-net discounting for XOLREMDI.

    Answer

    Paula Ragan (Executive) and Christophe Arbet-Engels (Executive) explained the trial protocol change was aligned with the FDA and EMA to focus on moderate-to-severe patients, maximizing the chance of success without impacting enrollment timelines. Adam Mostafa (Executive) noted that inventory levels reflect Q4 stocking and will likely be lumpy. Mark Baldry (Executive) confirmed the company is not currently engaging in product discounting.

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    Stephen Willey's questions to X4 Pharmaceuticals Inc (XFOR) leadership • Q3 2024

    Question

    Stephen Willey from Stifel questioned if the Phase II data showed any correlation between CN subtype or baseline G-CSF dose and the magnitude of G-CSF reduction. He also asked for a more precise metric on how many targeted HCPs are actively screening for WHIM.

    Answer

    CEO Paula Ragan and Chief Medical Officer Christophe Arbet-Engels responded that mavorixafor's effect was robustly consistent and the Phase II sample size was too small to draw definitive correlations, which will be analyzed in the larger Phase III trial. Chief Commercial Officer Mark Baldry added that the commercial team is focused on making physicians aware of WHIM through claims analysis and conference presence to encourage screening, rather than tracking a specific number of active screeners at this stage.

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    Stephen Willey's questions to X4 Pharmaceuticals Inc (XFOR) leadership • Q2 2024

    Question

    Stephen Willey asked about the kinetics of the reimbursement process for XOLREMDI, how the company plans to communicate enrollment progress for the Phase III 4WARD trial, and for an explanation of the sequential decrease in SG&A expenses.

    Answer

    Chief Commercial Officer Mark Baldry reported that the reimbursement process is working smoothly through prior authorizations and medical exceptions, supported by the X4Connect patient hub. President and CEO Dr. Paula Ragan noted that meaningful updates on 4WARD trial enrollment are expected in 2025. CFO Adam Mostafa clarified that Q2 SG&A represents a more typical run-rate, as Q1 was inflated by one-time launch preparation costs.

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    Stephen Willey's questions to Abcellera Biologics Inc (ABCL) leadership

    Stephen Willey's questions to Abcellera Biologics Inc (ABCL) leadership • Q4 2024

    Question

    Stephen Willey of Stifel inquired about AbCellera's strategy of being 'indication agnostic' and the competencies required for clinical trials across diverse areas. He also asked about the specifics of the AbbVie T-cell engager (TCE) collaboration and whether competitive headwinds from China are impacting business development.

    Answer

    CEO Carl L. Hansen explained that being indication agnostic allows them to pursue the best opportunities broadly. He stated that clinical development teams are being built 'on time' to support the initial programs, with future hiring focused on development roles. Regarding the AbbVie deal, he described it as a significant first collaboration on a small number of targets. Hansen also noted that while they see competitive dynamics from China, AbCellera's focus on highly differentiated, first-in-class assets provides a robust defense.

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    Stephen Willey's questions to Abcellera Biologics Inc (ABCL) leadership • Q3 2024

    Question

    Stephen Willey of Stifel asked about the number of T cell engager programs AbCellera could advance independently, the timeline for its ongoing portfolio review, and whether Canadian government funding mandates that clinical development occurs in Canada.

    Answer

    President and CEO Dr. Carl Hansen addressed the pipeline, stating the company has nearly $900 million in liquidity to fund an anticipated 2-3 new development candidates per year and that the portfolio review will conclude by December. CFO Andrew Booth confirmed that the government funding requires Phase I trials to be conducted in Canada, which they plan to do for ABCL575 and ABCL635 without anticipating any issues.

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