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    Xun Lee

    Vice President and Equity Research Analyst at H.C. Wainwright & Co., LLC

    Xun Lee is a Vice President and Equity Research Analyst at H.C. Wainwright & Co., LLC, specializing in the biotechnology and pharmaceuticals sectors. He covers a range of innovative biotech companies, including those engaged in oncology, rare diseases, and advanced therapeutics, and is recognized for his deep technical expertise and detailed company analyses. Lee has rapidly established himself since joining H.C. Wainwright, leveraging a background in scientific research and previous roles at leading life sciences investment firms to deliver well-ranked stock recommendations with measurable accuracy and value for institutional clients. He holds FINRA Series 7 and 63 registrations and is noted for his thorough sector insights and strong relationships with both management teams and investors.

    Xun Lee's questions to EDAP TMS (EDAP) leadership

    Xun Lee's questions to EDAP TMS (EDAP) leadership • Q1 2025

    Question

    Xun Lee of H.C. Wainwright & Co. asked about the company's strategy for the endometriosis indication, specifically seeking details on the next steps for marketing in Europe following CE Mark approval and the development plans for the U.S. market.

    Answer

    Executive Ryan Rhodes explained that for Europe, EDAP is initiating a controlled market entry, working with a select group of hospitals to expand clinical development before a broader launch. For the U.S., the company is focused on tracking data from its Phase II and III studies, including from patients who chose Focal One ablation post-trial, to support future interactions with the FDA.

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    Xun Lee's questions to EDAP TMS (EDAP) leadership • Q1 2025

    Question

    Xun Lee of H.C. Wainwright asked about EDAP's strategy for endometriosis, questioning the next steps for marketing in Europe following CE Mark approval and the company's plans for the U.S. market.

    Answer

    Executive Ryan Rhodes explained that the company is pursuing a 'controlled market entry' in Europe, working with a select group of hospitals to expand clinical development before a wider launch. For the U.S., he stated that EDAP is focused on leveraging data from its previous clinical trials, including from patients who chose Focal One ablation post-trial, to support future discussions with the FDA.

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    Xun Lee's questions to EDAP TMS (EDAP) leadership • Q1 2025

    Question

    Xun Lee asked about EDAP's strategy for marketing Focal One for endometriosis in Europe following the recent CE Mark approval, and inquired about the company's development plans for the endometriosis indication in the United States.

    Answer

    Executive Ryan Rhodes explained that the company is undertaking a 'controlled market entry' in Europe, working with a select group of hospitals to expand clinical development before a broader launch. For the U.S., he stated the focus is on leveraging data from post-trial patient treatments to inform future discussions with the FDA, while the immediate priority remains the controlled launch in Europe.

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    Xun Lee's questions to EDAP TMS (EDAP) leadership • Q1 2025

    Question

    Xun Lee of H.C. Wainwright & Co. asked about the company's strategy for the endometriosis indication, seeking details on the next steps for marketing in Europe following CE Mark approval and the corresponding plans for the U.S. market.

    Answer

    Executive Ryan Rhodes explained that the company is initiating a controlled market entry in Europe, collaborating with a select group of hospitals to expand clinical development before a wider launch. For the U.S., he stated that EDAP is leveraging data from its clinical trials, including from patients who chose Focal One ablation post-trial, to support future interactions with the FDA.

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    Xun Lee's questions to EDAP TMS (EDAP) leadership • Q3 2024

    Question

    Xun Lee asked for an update on the clinical programs, specifically requesting the timeline for initial results from the BPH study and the expected patient count. He also questioned if the planned U.S. BPH study would be modified based on the French study's results. Finally, he inquired about the follow-up duration for the endometriosis study and the timing for longer-term data release.

    Answer

    Executive Ryan Rhodes stated that initial BPH study results are not expected until later in 2025. He explained the combined Phase I/II study design is intended to accelerate findings on treatment parameters before expanding enrollment. Regarding the U.S. study, he confirmed they will use the French study's results to design the protocol for the FDA. For the endometriosis program, Rhodes noted they can follow patients for 12 months and beyond and plan to meet with the FDA by year-end to discuss recent findings, including the 85% crossover rate from the sham arm, which supports a longer follow-up period.

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    Xun Lee's questions to Cytosorbents (CTSO) leadership

    Xun Lee's questions to Cytosorbents (CTSO) leadership • Q1 2025

    Question

    Xun Lee inquired whether the new clinical and real-world data from the STAR registry would aid in marketing or securing reimbursement for CytoSorb in Europe, and asked if there were any active reimbursement discussions in countries outside of Germany.

    Answer

    Dr. Makis Deliargyris, Chief Medical Officer, confirmed that strong clinical data is the core of their value proposition and will absolutely be leveraged to support reimbursement and health technology assessments in the EU. CEO Dr. Phillip Chan added that cardiac surgery is an area with clear data where they have active reimbursement discussions ongoing, highlighting the United Kingdom as an example where cardiac surgery is a top revenue-driving application.

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    Xun Lee's questions to Corvus Pharmaceuticals (CRVS) leadership

    Xun Lee's questions to Corvus Pharmaceuticals (CRVS) leadership • Q1 2025

    Question

    Xun Lee asked about the potential for soquelitinib to be used in combination therapies for atopic dermatitis or other indications, given its favorable safety profile.

    Answer

    Richard Miller, an executive, agreed that the drug's non-overlapping mechanism, safety profile, and convenient oral administration create a significant opportunity for combination therapies with agents like IL-4/13 inhibitors (e.g., DUPIXENT) or anti-IL-13s. However, he clarified that for the time being, the company's focus remains on advancing soquelitinib as a monotherapy.

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    Xun Lee's questions to Corvus Pharmaceuticals (CRVS) leadership • Q4 2024

    Question

    Xun Lee asked about the planned solid tumor study for soquelitinib, questioning which specific cancer indications are most suitable and whether a new dose-escalation study would be required or if the company would start with the dose used in the PTCL trial.

    Answer

    Executive Richard Miller responded that the trial will start with immune-responsive tumors, identifying renal cell cancer and lung cancer as top choices. He stated that a traditional dose-escalation study is not needed, as the company has a good understanding of the dose required to saturate the ITK target. However, the study would likely still evaluate different dose levels within that effective range.

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    Xun Lee's questions to Alphatec Holdings (ATEC) leadership

    Xun Lee's questions to Alphatec Holdings (ATEC) leadership • Q1 2025

    Question

    Xun Lee inquired about which components of ATEC's pre-op (EOS), intra-op (SafeOp), and post-op ecosystem are seeing the most use and where future growth is expected.

    Answer

    Executive Patrick Miles explained that adoption is tied to maturity. SafeOp is a mature and core driver of the company's successful lateral business, which he described as being in the 'third inning.' In contrast, the EOS informatics platform is in the 'first inning,' with its key translational software launched only last year. This indicates that while SafeOp is currently a major contributor, the EOS ecosystem represents a significant future growth runway.

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    Xun Lee's questions to Alphatec Holdings (ATEC) leadership • Q3 2024

    Question

    Xun Lee asked about the drivers behind the company's consistent outperformance of its revenue guidance and whether this trend is sustainable.

    Answer

    Executive J. Koning attributed the outperformance primarily to higher-than-anticipated surgical volume. He explained that this reflects strong surgeon adoption of ATEC's technology and procedures, which has been advanced by the expansion of the sales force. He concluded that the greater-than-expected volume gives the company confidence that its strategy is resonating in the market.

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    Xun Lee's questions to MYOMO (MYO) leadership

    Xun Lee's questions to MYOMO (MYO) leadership • Q4 2024

    Question

    Sean Lee of H.C. Wainwright asked about the primary reasons for authorization denials, the company's strategy to mitigate them, the expected growth from the O&P channel, and the outlook for international markets in 2025.

    Answer

    CEO Paul Gudonis explained that denials are typically based on claims of the device being 'experimental' or not 'medically necessary,' which Myomo refutes using its extensive payment history, CMS approval, and physician documentation. CFO Dave Henry reiterated that O&P channel growth would be 'meaningful' in 2025. Paul Gudonis added that the German market is expected to continue its steady growth, which remains the company's primary international focus.

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    Xun Lee's questions to PLUS THERAPEUTICS (PSTV) leadership

    Xun Lee's questions to PLUS THERAPEUTICS (PSTV) leadership • Q3 2024

    Question

    Xun Lee from H.C. Wainwright & Co., LLC asked for details on the ReSPECT-LM multi-dose study's dosage rationale and the commercialization and reimbursement timeline for the CNSide diagnostic assay.

    Answer

    Executive Marc Hedrick explained that the 13 millicuries dose is a fractionated amount from Cohort 4, an approach favored by the FDA for the multi-dose study. Regarding CNSide, Hedrick stated the commercial launch is planned for early 2025, with key reimbursement milestones like the CLIA compliance inspection expected in Q1 2025. He noted the market access team is actively renegotiating payer agreements and expects to provide financial guidance once reimbursement is more established.

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    Xun Lee's questions to PLUS THERAPEUTICS (PSTV) leadership • Q2 2024

    Question

    Xun Lee of H.C. Wainwright & Co. inquired about the next steps for commercializing the CNSide assay, the rationale for continuing the single-dose LM study alongside the new multi-dose trial, and the timeline for updates from the ReSPECT-GBM study.

    Answer

    Executive Marc Hedrick detailed that for CNSide, the company has brought chip manufacturing in-house, hired a medical director, and applied for CLIA certification, with a full commercial plan under evaluation. He clarified that the single-dose LM study will continue because the FDA is keen on establishing a maximum tolerated dose (MTD). For the GBM study, Hedrick confirmed a significant data update is planned for the CNS annual meeting in late Q3/early Q4 2024, with full enrollment now expected in the first half of 2025.

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