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    Edward White • H.C. Wainwright & Co.

    Edward White's questions to TG Therapeutics Inc (TGTX) leadership

    Edward White's questions to TG Therapeutics Inc (TGTX) leadership • Q4 2024

    Question

    Edward White asked about the anticipated size and enrollment timeline for the subcutaneous BRIUMVI trial and sought clarity on the breakdown of the 2025 OpEx guidance between SG&A and R&D.

    Answer

    CEO Michael Weiss estimated the subcutaneous trial would likely involve 125 to 150 patients per arm, with an enrollment period of approximately 12 months. Chief Commercialization Officer Adam Waldman noted the sales force is largely rightsized but may see strategic, non-material additions. The executives did not provide a specific SG&A vs. R&D breakdown for the OpEx guidance.

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    Edward White's questions to TG Therapeutics Inc (TGTX) leadership • Q3 2024

    Question

    Edward White of H.C. Wainwright & Co. asked for a big-picture view on the 2025 anti-CD20 MS market, BRIUMVI's potential market share, the IV versus subcutaneous split, and the gross margin impact of the new FUJIFILM manufacturing deal.

    Answer

    Chief Commercialization Officer Adam Waldman projected the CD20 market share could grow from the low 50s to 60%, with BRIUMVI having significant room to grow from its current 15% share. He noted the IV market remains dominant at ~70%. Chief Financial Officer Sean Power stated the new manufacturing agreement will not impact gross margins in the near term, with any upfront costs running through R&D.

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    Edward White's questions to Dynavax Technologies Corp (DVAX) leadership

    Edward White's questions to Dynavax Technologies Corp (DVAX) leadership • Q4 2024

    Question

    Edward White asked for expectations on the potential size and timing of a global Phase III study for the shingles vaccine and for management's thoughts on the potential market size for the plague vaccine program.

    Answer

    CEO Ryan Spencer stated that it is premature to provide details on the shingles Phase III trial design or timeline, as it will depend on upcoming data and discussions with regulators and potential partners. Regarding the plague vaccine, he explained the market size is dependent on the U.S. government's threat assessment, which could range from a smaller opportunity focused on military personnel to a much larger one for the general population.

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    Edward White's questions to Inhibikase Therapeutics Inc (IKT) leadership

    Edward White's questions to Inhibikase Therapeutics Inc (IKT) leadership • Q2 2024

    Question

    Edward White of H.C. Wainwright & Co. asked for clarification on what specific outcomes from the November top-line data for risvodetinib would be necessary to advance to Phase III trials. He also questioned whether the planned 300-patient Phase III enrollment was for each trial or combined. Regarding IkT-001Pro, he inquired about expectations for IND clearance, potential gating factors for the trial start, and the anticipated timeline for initiation.

    Answer

    Executive Milton Werner explained that seeing any positive trend on motor/nonmotor features or protein pathology biomarkers in the November data would provide robust support to proceed to Phase III. He clarified that the 300-400 patient estimate is for both Phase III trials combined. For the IkT-001Pro trial, Werner stated the primary gating factor is securing capital, as current cash is insufficient. He estimated a 9-12 month timeline to fully prepare for the trial start after funding is secured, noting that IND clearance is anticipated without major issues.

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    Edward White's questions to Inhibikase Therapeutics Inc (IKT) leadership • Q1 2024

    Question

    Edward White of H.C. Wainwright & Co. inquired about the success criteria for the Risvodetinib trial, the potential clinical trial design for IkT-001Pro in Pulmonary Arterial Hypertension (PAH), and the current status of partnership discussions for the 001Pro asset.

    Answer

    Executive Milton Werner explained that a positive result for Risvodetinib would be a combination of favorable biomarker data impacting alpha-synuclein pathology and positive trends in quality of life scores. For IkT-001Pro, he outlined a standard Phase II/III trial design for PAH, with a Phase II primary endpoint of pulmonary vascular resistance and a Phase III endpoint of 6-minute walking distance, noting the key is to confirm an improved safety profile over standard imatinib. Werner also confirmed that the company is in active partnership discussions for 001Pro with multiple parties, with their position strengthened by recent positive FDA feedback on the drug's potential as a New Molecular Entity for PAH.

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    Edward White's questions to Nyxoah SA (NYXH) leadership

    Edward White's questions to Nyxoah SA (NYXH) leadership • Q2 2024

    Question

    Edward White asked for details on Nyxoah's U.S. reimbursement strategy for its Genio system ahead of the anticipated launch.

    Answer

    CEO Olivier Taelman detailed the strategy, highlighting a partnership with the American Association of Otolaryngology (AAO) to establish a bridge Category 1 CPT code for use at launch. This ensures immediate Medicare coverage at rates in line with current AG&S payments. He added that the company is engaging with commercial payers, leveraging existing AG&S coverage policies, and participating in the FDA's payer feedback program to ensure broad market access.

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