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    Rick Miller • C.L. King & Associates

    Rick Miller's questions to ADMA Biologics Inc (ADMA) leadership

    Rick Miller's questions to ADMA Biologics Inc (ADMA) leadership • Q1 2025

    Question

    Rick Miller, on behalf of Kristen Kluska, inquired about the progress of onboarding approximately 250 new plasma collection centers and what percentage are currently contributing to the plasma supply. He also asked for an update on the company's strategy for retaining high-titer donors for ASCENIV production.

    Answer

    President and CEO Adam Grossman confirmed that substantially all new centers are now sending samples and that plasma collection is running ahead of forecast, contributing to the increased guidance. He stated that the current strategy for retaining high-titer donors, which involves premium compensation and treatment, is working very well and requires no changes. He highlighted that ASCENIV's mid-80% gross margins already account for higher donor fees and will expand further with the new yield enhancement.

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    Rick Miller's questions to Codexis Inc (CDXS) leadership

    Rick Miller's questions to Codexis Inc (CDXS) leadership • Q4 2024

    Question

    Rick Miller asked about the primary drivers for adopting the ECO Synthesis platform in rare disease markets and how Codexis intends to communicate new partnership agreements to investors.

    Answer

    President and CEO Dr. Stephen Dilly explained that adoption in rare disease markets will be driven by both the platform's validation and its unique ability to perform complex enzymatic synthesis that is difficult chemically. Regarding partnerships, Dr. Dilly emphasized that Codexis must be extremely careful, prioritizing partner confidentiality and the relationship over publicizing partner names, especially when launching a disruptive technology that provides a competitive advantage.

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    Rick Miller's questions to Fulcrum Therapeutics Inc (FULC) leadership

    Rick Miller's questions to Fulcrum Therapeutics Inc (FULC) leadership • Q4 2024

    Question

    Rick Miller of Goldman Sachs inquired about the timeline for meeting with the FDA regarding the 12mg and 20mg pociredir cohorts and asked about the current clinical bar for fetal hemoglobin (HbF) and VOC reduction in the evolving sickle cell disease landscape.

    Answer

    Executive Iain Fraser explained that Fulcrum may approach the FDA with data from the 12mg cohort alone if the results are compelling, rather than waiting for both cohorts to complete. He noted that even a 1% HbF increase correlates to a 4-8% VOC reduction, with levels in the mid-20s being potentially transformational. CEO Alexander Sapir added that the company is also separately engaging the agency on using HbF as a surrogate endpoint for future studies.

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    Rick Miller's questions to Fulcrum Therapeutics Inc (FULC) leadership • Q3 2024

    Question

    Rick Miller, on for Kristen Kluska at Cantor Fitzgerald, asked for details on the planned healthy volunteer studies for pociredir, including the dosing strategy and the primary outcomes, such as safety versus PK/PD measures.

    Answer

    Chief Scientific Officer Iain Fraser responded that the studies are primarily focused on pharmacokinetics (PK) to assess absorption, distribution, and metabolism, using standard methods like radio-label studies. They will also evaluate new formulations and drug-drug interactions. While safety and tolerability are key endpoints, the main driver of the studies is the PK data needed to inform the patient clinical program.

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    Rick Miller's questions to Abeona Therapeutics Inc (ABEO) leadership

    Rick Miller's questions to Abeona Therapeutics Inc (ABEO) leadership • Q2 2024

    Question

    Rick Miller, on behalf of Kristen Kluska at Cantor Fitzgerald, asked for more characterization of the statistical approach suggested by the FDA for one of the outstanding assays, questioning if it was a more stringent method and the agency's motivation for the suggestion.

    Answer

    CEO Vishwas Seshadri responded that the FDA's motivation was based on precedent and a preference for a specific statistical method to establish comparability between Abeona's rapid sterility assay and the existing gold standard. He clarified the feedback provided clear instructions for statistical handling to demonstrate equivalent sensitivity, rather than being an inherently more stringent biological requirement.

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