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    Roger Song • Jefferies LLC

    Roger Song's questions to Altimmune Inc (ALT) leadership

    Roger Song's questions to Altimmune Inc (ALT) leadership • Q2 2025

    Question

    Roger Song from Jefferies asked about the remaining work required before requesting the end-of-Phase 2 meeting and how much 48-week data is necessary for the Phase 3 proposal. He also inquired how the new Chairman appointment might alter the company's strategy on partnerships and commercialization.

    Answer

    Chief Medical Officer Dr. M. Scott Harris expressed confidence in holding the FDA meeting by year-end, noting they have sufficient data. CEO Dr. Vipin Garg described the Chairman change as a 'natural evolution' to leverage the new appointee's experience in liver disease and M&A as the company advances toward Phase 3.

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    Roger Song's questions to Altimmune Inc (ALT) leadership • Q1 2025

    Question

    Roger Song of Jefferies questioned which of the dual primary endpoints in the IMPACT study is historically harder to achieve and asked about the correlation between the recently presented MASH resolution index and fibrosis improvement.

    Answer

    CBO Ray Jordt acknowledged that fibrosis improvement has historically been the more challenging endpoint to hit. He explained that the MASH resolution index is highly predictive of MASH resolution and emphasized that liver fat reduction, where pemvidutide is a leader, is the primary driver for both MASH resolution and fibrosis improvement, giving them confidence in the trial's success.

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    Roger Song's questions to Kura Oncology Inc (KURA) leadership

    Roger Song's questions to Kura Oncology Inc (KURA) leadership • Q2 2025

    Question

    Roger Song inquired about the criteria for the recently decided RCC expansion cohort for KO-2806, the next steps for the PIK3CA and KRAS programs, and whether there have been any recent FDA interactions regarding the Phase 3 pivotal design for Zifdomenib.

    Answer

    Chief Medical Officer Dr. Mollie Leoni explained that the RCC expansion cohort decision was based on meeting pre-set criteria and is designed to fulfill Project Optimus requirements. Regarding the FDA, she confirmed interactions are routine for an agreed-upon design and that everything is proceeding as planned for the COMET-seventeen trials.

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    Roger Song's questions to Novavax Inc (NVAX) leadership

    Roger Song's questions to Novavax Inc (NVAX) leadership • Q2 2025

    Question

    Roger Song of Jefferies inquired about Novavax's regulatory filing and supply readiness for the 2025-2026 COVID-19 season, and also asked for an update on the progress and timeline for securing a partnership for its COVID-influenza combination (CIC) vaccine.

    Answer

    EVP, CFO & Treasurer Jim Kelly confirmed that the JN.1 vaccine's BLA is approved and current regulatory efforts are focused on extending its shelf life. President, CEO & Director John Jacobs stated that while active discussions with multiple potential partners for the CIC vaccine are underway, details remain confidential. He highlighted positive commentary from Sanofi on the asset's potential. EVP, Head of Research & Development Ruxandra Draghia-Akli added that the recent trial was a Phase 1 cohort to strengthen the data package for potential partners, who would conduct any future registrational trials.

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    Roger Song's questions to United Therapeutics Corp (UTHR) leadership

    Roger Song's questions to United Therapeutics Corp (UTHR) leadership • Q2 2025

    Question

    Roger Song from Jefferies asked what would be considered a clinically meaningful FVC result from the TETON trial, what a 'homerun' scenario would entail, and what proportion of TETON patients have concomitant pulmonary hypertension.

    Answer

    Dr. C.Q. Deng, SVP of Biostatistics, responded that the TETON study was designed to test the anti-fibrotic effect of treprostinil, not its vasodilator effect. Therefore, the study enrolled a typical IPF population, and the company did not perform hemodynamic measures to determine if subjects had pulmonary hypertension.

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    Roger Song's questions to WAVE Life Sciences Ltd (WVE) leadership

    Roger Song's questions to WAVE Life Sciences Ltd (WVE) leadership • Q2 2025

    Question

    Roger Song from Jefferies asked for guidance on expectations for the upcoming WVE-006 (AATD) data, specifically the differences between the multi-dose and single-dose cohorts and whether to focus on absolute M-protein levels or percentage of total protein. He also inquired about the follow-up period for the WVE-007 (Inhibin E) data readout in Q4.

    Answer

    President & CEO Paul Bolno stated that the 200 mg multi-dose cohort is expected to have greater liver exposure than the 400 mg single-dose, making it a key focus. He anticipates seeing higher protein levels than the initial single-dose data, which already achieved MZ phenotype levels. Bolno emphasized that M-protein is a critical, standardized measure to follow. For WVE-007, he confirmed at least three months of follow-up data would be available for cohorts one and two at the time of the Q4 readout.

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    Roger Song's questions to Kiniksa Pharmaceuticals International PLC (KNSA) leadership

    Roger Song's questions to Kiniksa Pharmaceuticals International PLC (KNSA) leadership • Q2 2025

    Question

    Roger Song from Jefferies asked about the target efficacy profile for KPL-387 that would be considered successful in the Phase 2 dose-finding portion, and also inquired about the potential indications for the company's quarterly IL-1 inhibitor.

    Answer

    EVP & CCO Ross Moat explained that for KPL-387, they are looking for a profile similar to Arcalis—the ability to treat acute flares and prevent subsequent ones—and will use the totality of data to select the dose. Regarding the quarterly IL-1 asset, he noted that while no specific indication has been announced, it has broad potential in chronic auto-inflammatory diseases, and the immediate focus is on IND-enabling studies.

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    Roger Song's questions to Viking Therapeutics Inc (VKTX) leadership

    Roger Song's questions to Viking Therapeutics Inc (VKTX) leadership • Q2 2025

    Question

    Roger Song from Jefferies asked for expectations on the high-dose versus maintenance-dose cohorts in the upcoming Phase II oral data. He also inquired if a weekly oral dosing regimen would be considered for the maintenance study.

    Answer

    President & CEO Brian Lian confirmed that a weekly oral cohort will be included in the upcoming maintenance study. Regarding the Phase II oral study, he highlighted the cohort that titrates up to 90mg and then steps down to 30mg as particularly informative for a maintenance strategy. He reiterated that achieving mid-to-high single-digit weight loss, similar to the 8% seen in Phase I, would be a strong result.

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    Roger Song's questions to Corvus Pharmaceuticals Inc (CRVS) leadership

    Roger Song's questions to Corvus Pharmaceuticals Inc (CRVS) leadership • Q4 2024

    Question

    On behalf of Roger Song, Cha Cha Yang asked for details on the planned Phase II trial for soquelitinib in atopic dermatitis, specifically regarding the target patient subpopulations, including prior medication use, baseline EASI scores, and any geographic or demographic considerations.

    Answer

    Executive Richard Miller provided a preliminary outline, stating that while Phase I is not yet complete, the Phase II trial would likely target patients with moderate-to-severe AD who have failed topical or systemic therapies. He suggested a standard design, possibly a three-arm study with two dose levels plus placebo, enrolling around 200 patients total. The primary endpoint would likely be EASI 75 or IGA 0/1, which are standard for registration.

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