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    Daniil Gataulin • Chardan

    Daniil Gataulin's questions to Regenxbio Inc (RGNX) leadership

    Daniil Gataulin's questions to Regenxbio Inc (RGNX) leadership • Q2 2025

    Question

    Daniil Gataulin inquired if Regenxbio is considering an earlier FDA meeting for RGX-202 due to industry uncertainty and asked about the supply strategy for the SCS Microinjector, given that partner Clearside is restructuring.

    Answer

    President & CEO Curran Simpson expressed confidence in the microinjector supply, citing significant inventory and contractual provisions. Regarding the FDA, he stated that while they are considering it, there is no urgency for an earlier meeting for RGX-202. He noted they are in constant contact with review teams and are not detecting any shifts in expectations, and that recent events in DMD underscore the urgency for new therapies.

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    Daniil Gataulin's questions to Regenxbio Inc (RGNX) leadership • Q3 2024

    Question

    Daniil Gataulin of Chardan requested details on the newly authorized RGX-202 clinical trial in Canada and asked about plans for a bilateral (fellow eye) study for the suprachoroidal RGX-314 program.

    Answer

    Dr. Steve Pakola, CMO, confirmed the expansion into Canada and stated that data from Canadian sites will be relevant for the pivotal submission. For RGX-314, he said it is a logical next step to evaluate bilateral treatment with the suprachoroidal delivery method, and they are confident in doing so due to its compartmentalized delivery and favorable safety profile seen in single-eye studies.

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    Daniil Gataulin's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership

    Daniil Gataulin's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q2 2025

    Question

    Daniil Gataulin of Chardan Capital Markets inquired about the fraction of U.S. versus ex-U.S. patients in the LUCHIA trial and the level of awareness and interest in DuraVu outside the United States.

    Answer

    CEO Jay Duker estimated the LUCHIA trial enrollment was approximately 80% U.S. and 20% ex-U.S., attributing the split to the rapid pace of enrollment in the U.S. before international sites were fully activated. He described the interest from ex-U.S. patients and practitioners as 'really, really great,' noting the significant need for durable therapies in countries where frequent injections pose a challenge.

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    Daniil Gataulin's questions to Ocugen Inc (OCGN) leadership

    Daniil Gataulin's questions to Ocugen Inc (OCGN) leadership • Q2 2025

    Question

    Daniil Gataulin from Chardan Capital Markets inquired about the OCU200 Phase 1 trial, asking about patient and physician interest and the timeline for initial data. He also sought details on the regulatory approval path for OCU400 in Korea and other Asian markets, and asked about the company's recent interactions with the FDA, particularly any impact from the recent leadership change at CBER.

    Answer

    Chief Medical Officer Dr. Huma Qamar reported that OCU200 is dosing in Cohort 3 with data expected late this year, noting good investigator interest due to its potential for non-responders to existing therapies. CEO Shankar Musunuri explained that the regulatory path in Korea and other markets will likely leverage the U.S. FDA approval, avoiding the need for additional local trials. He also stated that interactions with the FDA remain positive and prompt, with no negative impact observed on their programs following the leadership change at CBER.

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    Daniil Gataulin's questions to Ocugen Inc (OCGN) leadership • Q1 2025

    Question

    Stephen, on behalf of Daniil Gataulin, asked whether patients treated in Europe are required for an OCU400 filing in the region, or if data from the U.S. and Canada would be sufficient.

    Answer

    Chief Medical Officer Dr. Huma Qamar stated that no additional trials or patients from Europe are necessary for the MAA filing. She explained that the current trial in the U.S. and Canada is sufficient for European approval, as it provides adequate representation of global mutations for the gene-agnostic therapy.

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    Daniil Gataulin's questions to Ocugen Inc (OCGN) leadership • Q4 2024

    Question

    Daniil Gataulin from Chardan questioned the manufacturing strategy for OCU410ST, asking if a commercial-grade product would be used in the pivotal study, and inquired about the geographic distribution of trial sites.

    Answer

    CEO Dr. Shankar Musunuri confirmed that a commercial-scale product, the same used in Phase I, will be used for the Phase II/III trial for OCU410ST, a strategy agreed upon with the FDA. He also stated that the company is confident it can recruit the 51-patient trial entirely within the U.S.

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    Daniil Gataulin's questions to Ocugen Inc (OCGN) leadership • Q3 2024

    Question

    Daniil Gataulin from Chardan inquired about Ocugen's strategy to capitalize on the lack of approved geographic atrophy treatments in Europe and any related regulatory interactions. He also asked about the potential for modifying the OCU410ST Phase II trial to serve as a pivotal study for registration.

    Answer

    Dr. Shankar Musunuri, CEO, responded that Ocugen plans to engage with EU regulators in the coming quarters for its geographic atrophy program, focusing on the functional endpoints they prioritize. Regarding the Stargardt program (OCU410ST), he confirmed they are exploring the possibility of converting the Phase II trial into a pivotal study. The company will pause to discuss this pathway with the FDA, citing new guidance for orphan disease gene therapies.

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