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    Edward White

    Managing Director and Senior Biotechnology Analyst at H.C. Wainwright & Co.

    Edward White is a Managing Director and Senior Biotechnology Analyst at H.C. Wainwright & Co., specializing in equity research for small to mid-cap life sciences and healthcare companies such as Tracon Pharmaceuticals, Inozyme Pharma, Lumos Pharma, Avalo Therapeutics, Aura Biosciences, Cullinan Therapeutics, and Dynavax Technologies. He has issued over 2,000 ratings and currently maintains a 35% success rate with an average return of -1.6% on TipRanks, including an exceptional 800% return for a buy rating on Chimerix. White began his career at Fahnestock and Company in 1996 and progressed through roles at BMO Capital Markets, Deutsche Bank Securities, Mitsubishi UFJ Trust, Murphy & Durieu, and FBR & Company before joining H.C. Wainwright in 2017. He holds a BS in Biology from Manhattan College, an MBA in Finance from Rensselaer Polytechnic Institute, and has active FINRA Series 7, 63, 86, and 87 licenses.

    Edward White's questions to CURIS (CRIS) leadership

    Edward White's questions to CURIS (CRIS) leadership • Q4 2024

    Question

    Edward White from H.C. Wainwright sought clarification on the target ORR, noting a potential change from a previously mentioned CR rate, and asked about the company's focus on its leukemia studies, including enrollment and data expectations.

    Answer

    CEO James Dentzer clarified that an ORR around 25% provides a significant cushion over the 10% null hypothesis. Regarding leukemia, he highlighted progress in the triplet study's 7-day cohort and KOL interest in a monotherapy FLT3 study. However, he was cautious about setting data timelines for 2025, pending further progress on study initiations.

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    Edward White's questions to CURIS (CRIS) leadership • Q3 2024

    Question

    Edward White of H.C. Wainwright & Co. asked about Curis's alignment with the FDA on a registrational path for emavusertib in PCNSL and inquired about the expected cadence of R&D and G&A expenses for Q4 and 2025.

    Answer

    President and CEO James Dentzer clarified that Curis is not 'out of alignment' with the FDA but is proactively engaged in discussions for a potential accelerated approval path for PCNSL, with hopes for clarity in Q1. Executive Diantha Duvall addressed expenses, stating that after recent cost modulation, the quarterly cash burn should remain around the $10 million mark in 2025, with some variability due to manufacturing timing.

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    Edward White's questions to TG THERAPEUTICS (TGTX) leadership

    Edward White's questions to TG THERAPEUTICS (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 (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 (DVAX) leadership

    Edward White's questions to DYNAVAX TECHNOLOGIES (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 Karyopharm Therapeutics (KPTI) leadership

    Edward White's questions to Karyopharm Therapeutics (KPTI) leadership • Q4 2024

    Question

    Edward White of H.C. Wainwright & Co. requested a breakdown of the 2025 XPOVIO revenue guidance, asking about the expected contribution from volume versus price growth. He also inquired about the expected trends in R&D versus SG&A spending for 2025.

    Answer

    Chief Commercial Officer Sohanya Cheng stated that the 2025 revenue growth plan is based on growing demand and building on the momentum from the second half of 2024, despite competitive headwinds and a gross-to-net discount expected to be similar to 2024. Chief Financial Officer Lori Macomber added that R&D spending in 2025 will be comparable to 2024 due to investment in Phase III trials, while SG&A expenses are expected to see a significant decline as the company realizes the full-year benefits of its cost optimization initiatives.

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    Edward White's questions to Karyopharm Therapeutics (KPTI) leadership • Q3 2024

    Question

    Edward White asked for an update on ex-U.S. launches and the 2025 outlook, and also inquired about the company's strategy for entering the endometrial cancer market with a maintenance therapy.

    Answer

    EVP, Chief Commercial Officer Sohanya Cheng stated that ex-U.S. royalties are expected to increase in 2025 due to ongoing launches, though major one-time reimbursement milestone payments from 2024 are not expected to recur. Regarding endometrial cancer, she highlighted the significant unmet need in the p53 wild-type subgroup and cited market research showing strong physician preference for SELINEXOR, noting the company's existing commercial infrastructure provides significant physician overlap for a rapid launch.

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    Edward White's questions to PUMA BIOTECHNOLOGY (PBYI) leadership

    Edward White's questions to PUMA BIOTECHNOLOGY (PBYI) leadership • Q3 2024

    Question

    Edward White asked for insights into the drivers behind NERLYNX sales exceeding expectations, the impact of patient persistence from lower starting doses, the company's business development strategy, and the nature of future sales to China.

    Answer

    Chief Commercial Officer Jeffrey Ludwig attributed the strong sales to the promotional sensitivity of NERLYNX, increased and better-timed physician engagement using data, and strong conversion of enrollments to new starts. He noted that lower starting doses improve persistence by 5-10% at any refill stage. CEO Alan Auerbach added that Puma is actively seeking to in-license commercial assets that could leverage its sales force and prepare for alisertib. He also confirmed that sales to China are expected to remain lumpy, consistent with historical patterns.

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

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

    Question

    Edward White of H.C. Wainwright & Co., LLC sought clarification on the specific outcomes Inhibikase needs to see from the November top-line data for risvodetinib to advance to Phase III trials. He also asked about potential gating factors, such as manufacturing or site selection, and the expected start date for the IkT-001Pro trial in PAH.

    Answer

    Executive Milton Werner explained that for risvodetinib, seeing any positive trend on motor/nonmotor features or protein pathology biomarkers in the 12-week data would provide robust support to proceed directly to Phase III. For the IkT-001Pro trial, Werner identified the primary gating factor as capital, noting their current cash is insufficient for a trial of this scale. He estimated a 9-12 month period to fully prepare for the trial start, citing the need to build infrastructure for the delicate patient population, though key investigators and sites have been identified.

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

    Question

    Edward White of H.C. Wainwright & Co. inquired about the criteria for a positive data result for Risvodetinib (risvo) and its subsequent approval pathway. He also asked about the potential trial design for IkT-001Pro in Pulmonary Arterial Hypertension (PAH) and the current status of partnership discussions for the asset.

    Answer

    Executive Milton Werner explained that a positive outcome for Risvodetinib would involve biomarker data showing an impact on alpha-synuclein pathology, coupled with positive trends in quality of life and Parkinson's disease rating scores over the 12-week trial. For IkT-001Pro, he outlined a standard Phase II/III trial design for PAH, beginning with a 140-patient Phase II study focused on pulmonary vascular resistance, which could roll into a Phase III trial with a 6-minute walk distance primary endpoint. Werner confirmed active partnership discussions are underway, noting that recent favorable FDA feedback on the drug's potential as a New Molecular Entity for PAH strengthens their negotiating position and that a partner is essential for funding the required trials.

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    Edward White's questions to Nyxoah (NYXH) leadership

    Edward White's questions to Nyxoah (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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    Edward White's questions to LUMO leadership

    Edward White's questions to LUMO leadership • Q1 2024

    Question

    Asked about the company's manufacturing readiness for Phase III, the planned geographical breakdown of trial sites, and for a counterargument on why an eligible patient might not want to take the oral product.

    Answer

    The company is well-prepared for manufacturing with a new patented drug product form (mini tablets in a capsule) ready for Phase III. The trial plans to enroll about 150 subjects across approximately 14 countries, with a significant number of sites outside the U.S. Regarding patient preference, the company believes the choice is clear, as research and physician feedback indicate an overwhelming preference for a daily oral therapy over injections, making it a highly attractive option for the majority of eligible patients.

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    Edward White's questions to GLYC leadership

    Edward White's questions to GLYC leadership • Q4 2023

    Question

    Asked about the financial terms of the GMI-1687 collaboration, the development strategy for that asset (alone or with a partner), and the company's strategy for uproleselan in Europe.

    Answer

    The company stated there is a modest financial component to the GMI-1687 collaboration. The decision to partner or develop it alone is still open, but the collaboration provides crucial insights regardless. For Europe, plans are underway and will be a focus after the FDA submission, leveraging experience from European trial sites.

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