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    Michael Okunewitch • Maxim Group

    Michael Okunewitch's questions to Belite Bio Inc (BLTE) leadership

    Michael Okunewitch's questions to Belite Bio Inc (BLTE) leadership • Q2 2025

    Question

    Michael Okunewitch of Maxim Group sought confirmation from the current FDA administration regarding a single pivotal trial design for full approval. He also asked about the potential scale of the commercial force needed for a market launch.

    Answer

    Chairman & CEO Tom Lin affirmed that the path for a single-study approval is 'very clear and very straightforward' provided they meet a robust statistical significance of p < 0.01. CFO & Director Hao-Yuan Chuang noted that the current four-year cash runway forecast does not yet include the full costs of commercialization, which are being budgeted.

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    Michael Okunewitch's questions to Belite Bio Inc (BLTE) leadership • Q1 2025

    Question

    Michael Okunewitch of Maxim Group requested more details on the timing and conditions for the interim analysis of the Geographic Atrophy (PHOENIX) trial and asked if the 500-patient enrollment target was final.

    Answer

    Chairman and CEO Dr. Tom Lin stated that the company would not disclose details on the GA interim analysis until receiving an official response from regulators. Both Dr. Lin and Chief Scientific Officer Dr. Nathan Mata confirmed there is no current plan for a sample size reestimation in the PHOENIX trial, as they are capitalizing on smooth enrollment to add more subjects upfront to strengthen the study.

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    Michael Okunewitch's questions to Belite Bio Inc (BLTE) leadership • Q4 2024

    Question

    Michael Okunewitch from Maxim Group asked about the statistical design of the DRAGON study, specifically inquiring about the difference in lesion growth between the placebo and treatment arms that the trial is powered to detect.

    Answer

    Chief Scientific Officer Dr. Nathan Mata answered directly, stating that the DRAGON study is powered for a 40% treatment effect with 80% power to detect that effect at the two-year endpoint.

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    Michael Okunewitch's questions to Belite Bio Inc (BLTE) leadership • Q3 2024

    Question

    Michael Okunewitch asked about the necessity of the DRAGON 2 trial for a U.S. filing, the potential for a broad label in GA, and the key differentiators between Tinlarebant and Alkeus's therapy.

    Answer

    Executive Tom Lin explained that DRAGON 2 is primarily for Japanese approval but could serve as a second pivotal study if needed by the FDA, and that they expect a broad GA label due to the convenience of an oral therapy. Chief Scientific Officer Nathan L. Mata detailed that Tinlarebant reduces all toxic vitamin A byproducts, including all-trans retinal, whereas Alkeus's drug increases vitamin A levels, which he believes is a critical mechanistic advantage for Tinlarebant.

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    Michael Okunewitch's questions to Ocugen Inc (OCGN) leadership

    Michael Okunewitch's questions to Ocugen Inc (OCGN) leadership • Q2 2025

    Question

    Michael Okunewitch of Maxim Group inquired about Ocugen's strategy for future deals, such as regional licenses or spin-outs, following the OrthoCelix and Korea agreements. He also asked for details on the Stargardt Phase 2/3 trial, including the number of sites and potential enrollment challenges, and sought context on what a 27% reduction in geographic atrophy (GA) lesion growth means for patients' vision.

    Answer

    CEO Shankar Musunuri confirmed that Ocugen is continuously exploring regional partnership opportunities for all its gene therapy programs. Chief Medical Officer Dr. Huma Qamar stated that the Stargardt trial has 15 centers, is on track for a 2027 BLA filing, and faces no anticipated enrollment challenges due to the large patient population and lack of approved treatments. Chief Scientific Officer Dr. Arun Upadhyay explained that the 27% lesion growth reduction in GA is significant and expected to preserve and enhance photoreceptor function, ultimately leading to gains in functional vision for patients over time.

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    Michael Okunewitch's questions to Ocugen Inc (OCGN) leadership • Q1 2025

    Question

    Michael Okunewitch inquired about the enrollment status and timeline for the OCU400 liMeliGhT study, the manufacturing capabilities required for filing and commercialization, and the expected timing for the next update on the OCU200 program.

    Answer

    Chief Medical Officer Dr. Huma Qamar confirmed the OCU400 trial is on track for enrollment in the first half of 2025, aligning with BLA submission plans. CEO Dr. Shankar Musunuri and CSO Dr. Arun Upadhyay detailed the manufacturing strategy, noting process validations are on target for this year, with initial supply from partner CanSino Bio before transitioning to their in-house Malvern facility. Dr. Musunuri also stated that the OCU200 Phase I trial should complete in late 2025, with a data update expected before year-end.

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    Michael Okunewitch's questions to Ocugen Inc (OCGN) leadership • Q4 2024

    Question

    Michael Okunewitch of Maxim Group asked about Ocugen's financial runway, the timeline for data from the OCU200 DME program, and the funding status for the OCU500 COVID-19 vaccine trial.

    Answer

    CEO Dr. Shankar Musunuri confirmed the current cash runway guidance already accounts for the newly planned OCU410ST Phase II/III study. Chief Medical Officer Dr. Huma Qamar stated that safety and efficacy data for the OCU200 Phase I trial are expected by the end of 2025. Dr. Musunuri also affirmed that the NIAID remains on track to initiate the Phase I trial for OCU500.

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    Michael Okunewitch's questions to Mediwound Ltd (MDWD) leadership

    Michael Okunewitch's questions to Mediwound Ltd (MDWD) leadership • Q1 2025

    Question

    Michael Okunewitch questioned the potential pricing strategy for EscharEx against SANTYL, considering factors like faster debridement and reduced healthcare utilization. He also asked if new NexoBrid stockpiling programs would be supplied from the new Israeli facility or require separate dedicated manufacturing.

    Answer

    Barry Wolfenson (executive) addressed pricing, stating that while the initial model compares product costs, a full health economics (HEOR) study is underway to assess downstream savings, which could justify a higher price premium. Ofer Gonen (executive) added that the company's multiple manufacturing facilities provide flexibility to support both the EscharEx launch and NexoBrid demand, including commercial sales and stockpiling, from various sites including the planned U.S. facility.

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    Michael Okunewitch's questions to Mediwound Ltd (MDWD) leadership • Q4 2024

    Question

    Michael Okunewitch asked for the rationale behind partnering with Kerecis for the DFU study and sought clarification on how the company expects to achieve its 2025 incremental revenue growth given the new manufacturing facility won't be approved until 2026.

    Answer

    CEO Ofer Gonen stated the strategy is to partner with the best-in-class products for each indication, selecting Kerecis for DFU based on its strong clinical results, similar to choosing MIMEDX for VLU. He clarified that the 2025 revenue growth of approximately $4 million is not dependent on the new facility but will be driven by a few extra weeks of production from the current facility, price increases, and a strategic shift to more profitable territories.

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    Michael Okunewitch's questions to Mediwound Ltd (MDWD) leadership • Q3 2024

    Question

    Michael Okunewitch of Maxim Group asked for details on the clinical work required for the temperature-stable NexoBrid, the potential market size of the European stockpiling opportunity, and the role of partners like Solveton in the head-to-head VLU study.

    Answer

    Ofer Gonen (Executive) stated the expectation is for a single, small clinical trial for the temperature-stable formulation, contingent on completing nonclinical work. He sized the European stockpiling market in the 'low tens of millions of dollars' annually, with shipments likely starting in 2026. Ryan Zimmerman (Company Representative) clarified that collaborations with companies like 3M (for its Kovan products) are to standardize care and minimize variability by providing best-in-class compression therapy for patients in the trial.

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    Michael Okunewitch's questions to BioLife Solutions Inc (BLFS) leadership

    Michael Okunewitch's questions to BioLife Solutions Inc (BLFS) leadership • Q4 2024

    Question

    Michael Okunewitch asked for more detail on the allocation of increased R&D spending and inquired about BioLife's involvement with any mesenchymal stem cell (MSC) based products.

    Answer

    CEO Roderick de Greef clarified that the additional R&D spend is for product line expansion, not new products, focusing on enhancing the Sexton-acquired consumables like the CryoCase and the CT-5 automated fill device. He offered to follow up separately regarding the company's specific involvement with MSC-based therapies.

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    Michael Okunewitch's questions to Compass Pathways PLC (CMPS) leadership

    Michael Okunewitch's questions to Compass Pathways PLC (CMPS) leadership • Q4 2024

    Question

    Michael Okunewitch, on behalf of Jason McCarthy, asked about the company's pipeline plans beyond TRD, such as for PTSD and anorexia, and whether the market adoption of SPRAVATO could help prepare the market for COMP360.

    Answer

    CEO Kabir Nath stated that the company's primary development focus is on TRD and PTSD, with data from a completed anorexia study expected in 2025. An executive confirmed that they believe SPRAVATO's success is beneficial, as it has educated healthcare providers on TRD and has only captured a small fraction of the large addressable patient population, indicating a significant opportunity for COMP360.

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