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    Vernon Bernardino • H.C. Wainwright

    Vernon Bernardino's questions to Humacyte Inc (HUMA) leadership

    Vernon Bernardino's questions to Humacyte Inc (HUMA) leadership • Q4 2024

    Question

    Vernon Bernardino of H.C. Wainwright asked about the sales force's educational process for new institutions, whether the ATEV supplemental BLA review would be faster than the original, and if the smaller CABG vessel would have a lower manufacturing cost.

    Answer

    Executive Laura Niklason described a 'two-pronged' educational strategy combining the sales team (teaching to the label) and medical affairs specialists (discussing published data and biology). She also noted the use of a new budget impact model for VAC committees. While hoping for a shorter review for the supplemental BLA, she declined to predict FDA timelines. She confirmed that the smaller, shorter CABG vessel will be less costly to produce as costs scale roughly with the mass of the tissue.

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    Vernon Bernardino's questions to Humacyte Inc (HUMA) leadership • Q3 2024

    Question

    Vernon Bernardino asked for an update on the BioVascular Pancreas (BVP) program, including next steps toward a human clinical study and the timeline for seeing early primate data, referencing recent successes in islet cell implantation by other institutions.

    Answer

    Executive Laura Niklason detailed that the BVP program is focused on optimizing islet dosing in primates to fully reverse the diabetic state. She highlighted the platform's key advantages: it is islet-source agnostic and allows for the retrieval of transplanted cells, unlike liver injections. While confident in the technology, she indicated that proving the principle in large animals is the priority before selecting an islet source for a first-in-man study. She advised to 'stay tuned' for primate data, suggesting it would be a 'few more months'.

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    Vernon Bernardino's questions to Novavax Inc (NVAX) leadership

    Vernon Bernardino's questions to Novavax Inc (NVAX) leadership • Q4 2024

    Question

    Vernon Bernardino inquired about potential changes to the 2025-2026 seasonal flu vaccine composition and asked how long manufacturers can wait for strain selection before needing to produce doses at risk.

    Answer

    Chief Medical Officer Robert Walker clarified there are no plans to extend the current Phase III cohort and that strain selection for a future vaccine would be aligned with public health authorities after a partner is secured. President and CEO John Jacobs declined to speculate on at-risk manufacturing timelines.

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    Vernon Bernardino's questions to Novavax Inc (NVAX) leadership • Q3 2024

    Question

    Vernon Bernardino from H.C. Wainwright & Co. asked how the CIC vaccine's flu component is designed to handle seasons with lower flu vaccine efficacy. He also requested insight into how the company's gross margins are expected to change in the future.

    Answer

    Chief Medical Officer Dr. Robert Walker explained that the CIC trial is a comparative immunogenicity study, not a clinical efficacy trial. Its primary endpoint is to show the immune response is non-inferior to a competitor vaccine, a metric independent of a given flu season's real-world effectiveness. CEO John Jacobs clarified that from 2025, traditional gross margin will not be a relevant metric, as product supplied to Sanofi will be on a cost-plus basis.

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