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    John Newman • Canaccord Genuity

    John Newman's questions to Delcath Systems Inc (DCTH) leadership

    John Newman's questions to Delcath Systems Inc (DCTH) leadership • Q2 2025

    Question

    John Newman of Canaccord Genuity Inc. asked for a long-term perspective on the NDRA program, questioning why the 340B pricing is attractive to hospitals and its potential to expand treatment volume over time.

    Answer

    CEO Gerard Michel explained that while the net effect is a 10-15% reduction in average revenue per kit in Q3, the program makes the product more attractive to hospitals on a portfolio basis. He believes this will lead to increased volume over time by removing a potential financial barrier for certain patients, although this effect is difficult to quantify.

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    John Newman's questions to Delcath Systems Inc (DCTH) leadership • Q4 2024

    Question

    John Newman of Canaccord Genuity inquired about the average number of HEPZATO treatment cycles per patient at newly activated U.S. centers and whether this figure is evolving as centers gain more experience with the procedure.

    Answer

    CEO Gerard Michel stated that while it's too early for a definitive trend, the average number of treatment cycles appears to be tracking consistently with the 4.1 cycles observed in the FOCUS trial. He expressed optimism for a potential increase due to strong product tolerability and anecdotal efficacy but emphasized it's premature to confirm.

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    John Newman's questions to Delcath Systems Inc (DCTH) leadership • Q3 2024

    Question

    John Newman from Canaccord Genuity inquired about the specific types of data expected from the CHOPIN trial in 2025 and asked about the projected timelines for patient enrollment in the upcoming colorectal and breast cancer trials.

    Answer

    CMO Vojo Vukovic explained that the 76-patient randomized CHOPIN trial is fully enrolled, with a data readout anticipated in mid-2025 and a public presentation in the second half of 2025. For the new Phase II trials, he projected that patient enrollment for the colorectal cancer study would begin in mid-2025, followed by the breast cancer study in Q4 2025. Each 90-patient trial is expected to take approximately two years to enroll.

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    John Newman's questions to Allogene Therapeutics Inc (ALLO) leadership

    John Newman's questions to Allogene Therapeutics Inc (ALLO) leadership • Q1 2025

    Question

    John Newman from Canaccord Genuity asked about the advantages of Allogene's off-the-shelf approach in autoimmune disease, specifically regarding the need for patients to taper off immunosuppressants.

    Answer

    Dr. Zachary Roberts, EVP of R&D and CMO, highlighted this as a key differentiator. He explained that unlike autologous therapies requiring patients to taper off immunosuppressants twice (for collection and infusion), ALLO-329 allows patients to remain on their medication until just before infusion. This simplifies the process and fits more naturally into patient care, a point of positive feedback from clinical sites.

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    John Newman's questions to Allogene Therapeutics Inc (ALLO) leadership • Q4 2024

    Question

    John Newman asked about the initial ALLO-329 data expected at year-end 2025, specifically the anticipated length of patient follow-up and whether the analysis can measure the depletion of activated T-cells in addition to B-cells.

    Answer

    EVP of R&D and CMO Dr. Zachary Roberts stated they expect to have a "handful of patients" with a "little bit of follow-up," sufficient for biomarker proof-of-concept (CAR T expansion, B-cell depletion, safety) but not durable efficacy. He confirmed they will conduct analyses to measure the depletion of CD70-positive T-cells, similar to the work done in the ALLO-316 program to validate the Dagger effect.

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    John Newman's questions to Y-mAbs Therapeutics Inc (YMAB) leadership

    John Newman's questions to Y-mAbs Therapeutics Inc (YMAB) leadership • Q1 2025

    Question

    John Newman asked a financial question regarding whether there was any impact from Medicaid reserve adjustments during the first quarter.

    Answer

    CFO Peter Pfreundschuh responded that the company is now seeing stabilization in its Medicaid and 340B gross-to-net calculations. He clarified that unlike the significant adjustments seen in 2024, Y-mAbs does not anticipate major changes to these reserves going forward in 2025.

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    John Newman's questions to Y-mAbs Therapeutics Inc (YMAB) leadership • Q2 2024

    Question

    John Newman of Canaccord Genuity asked about the commercial performance of DANYELZA, specifically whether the duration of therapy continues to mature in the U.S. and if this could be a meaningful driver of future growth.

    Answer

    Chief Commercial Officer Sue Smith confirmed that the company is seeing an increase in the duration of therapy. She also noted that a new marketing campaign, which highlights DANYELZA's efficacy in patients who have been on a prior GD2 therapy, is successfully increasing uptake among physicians for patients with bone or bone marrow involvement.

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    John Newman's questions to Seres Therapeutics Inc (MCRB) leadership

    John Newman's questions to Seres Therapeutics Inc (MCRB) leadership • Q1 2025

    Question

    John Newman inquired about the potential follow-up duration the FDA might require for the primary endpoint in the SER-155 Phase 2 study, and whether the trial is designed to assess overall survival as an endpoint.

    Answer

    President and CEO Eric Shaff noted that the study design incorporates prior FDA feedback. Dr. Dennis Walling, SVP of Clinical Development, confirmed the intended primary endpoint is the reduction of bloodstream infections, consistent with the Breakthrough Therapy Designation. Chief Scientific Officer Dr. Matthew Henn added that while the protocol is being finalized, the study is designed to be 'data rich' and will collect data to look for signals related to survivability, given known associations from other cohort studies.

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    John Newman's questions to Seres Therapeutics Inc (MCRB) leadership • Q4 2024

    Question

    John Newman from Canaccord Genuity asked about the potential size of the next clinical study for SER-155, assuming a Phase II trial. He also inquired about other potential efficacy endpoints that could be evaluated in addition to the primary endpoint of bloodstream infection reduction, such as acute Graft-versus-Host Disease (GvHD).

    Answer

    Eric Shaff, President and CEO, highlighted that a standalone Phase II study could provide an interim data readout within 12 months of initiation, which would be valuable for informing the path forward. Lisa von Moltke, CMO, mentioned that other endpoints would include febrile neutropenia, antibiotic use, and hospitalization rates. She noted that while GvHD would be tracked for safety, the low incidence rates observed in their Phase I study make it an unlikely efficacy endpoint. Eric Shaff also added that interim results could help inform expansion into adjacent patient populations.

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    John Newman's questions to Biontech SE (BNTX) leadership

    John Newman's questions to Biontech SE (BNTX) leadership • Q1 2025

    Question

    John Newman asked for BioNTech's thoughts on recent FDA comments about potentially requiring a randomized study for future COVID-19 vaccine strain updates and whether this is a feasible or likely scenario.

    Answer

    Chief Strategy Officer Ryan Richardson responded by noting the vaccine's initial approval was based on a large 43,000-participant randomized study. He stated that they do not expect this discussion to have a near-term impact on the franchise, as their immediate focus is on the upcoming strain selection process for the fall 2025 season.

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