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    Basma Radwan Ibrahim • Leerink Partners

    Basma Radwan Ibrahim's questions to Belite Bio Inc (BLTE) leadership

    Basma Radwan Ibrahim's questions to Belite Bio Inc (BLTE) leadership • Q1 2025

    Question

    Basma Radwan Ibrahim of Oppenheimer & Co. Inc. asked for an update on the PHOENIX trial's discontinuation rates and enrollment progress, and inquired about recent regulatory meetings concerning trial requirements for Stargardt disease.

    Answer

    Chairman and CEO Dr. Tom Lin stated the PHOENIX trial's dropout rate is approximately 20%, which he noted is well below rates seen in comparable studies. Chief Medical Officer Dr. Hendrik Scholl added that higher dropout rates are common for injectables and other visual cycle modulators. Regarding regulatory discussions for Stargardt disease, Dr. Lin confirmed that meetings are being scheduled but there were no updates to report at this time.

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    Basma Radwan Ibrahim's questions to Belite Bio Inc (BLTE) leadership • Q4 2024

    Question

    Basma Radwan Ibrahim, on behalf of Marc Goodman at Leerink Partners, asked if Belite Bio could get confirmation on a broad label for Stargardt disease beyond the adolescent study population when meeting with regulators. She also requested an update on the current discontinuation rates in the PHOENIX trial for Geographic Atrophy (GA).

    Answer

    Chairman and CEO Dr. Tom Lin stated the dropout rate for the PHOENIX trial is approximately 20%, which he noted is favorable compared to competitor studies. Chief Medical Officer Dr. Hendrik Scholl addressed the label question, explaining that since the disease is typically more severe in younger patients, demonstrating efficacy in adolescents should support a straightforward path to approval for adults as well. Chief Scientific Officer Dr. Nathan Mata added that a competitor's trial had a dropout rate over 40%.

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    Basma Radwan Ibrahim's questions to Belite Bio Inc (BLTE) leadership • Q3 2024

    Question

    Basma Radwan Ibrahim inquired about market research on the tolerance of geographic atrophy (GA) patients to ocular adverse events (AEs) and whether these AEs could affect the drug's market uptake.

    Answer

    Chief Scientific Officer Nathan L. Mata explained that while a slightly higher incidence of AEs might be expected in the more diseased GA population compared to Stargardt's patients, these events are manageable. He noted that in the ongoing PHOENIX trial with over 280 subjects, such AEs are observed in a minority of patients, indicating good overall tolerance.

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    Basma Radwan Ibrahim's questions to Xenon Pharmaceuticals Inc (XENE) leadership

    Basma Radwan Ibrahim's questions to Xenon Pharmaceuticals Inc (XENE) leadership • Q1 2025

    Question

    Basma Radwan Ibrahim, on for Marc Goodman, asked about the plan to assess efficacy for the Nav1.1 asset in Dravet syndrome given the competitive landscape, and whether the trial would also assess behavior and cognition.

    Answer

    President and CEO Ian Mortimer explained that their Nav1.1 program is differentiated as an oral small molecule targeting the underlying genetic cause of Dravet syndrome. He confirmed that the clinical development plan aims to assess not only seizure reduction but also disease-modifying endpoints related to cognition and behavior, which he believes is critical for treating genetically defined epilepsies.

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    Basma Radwan Ibrahim's questions to Amylyx Pharmaceuticals Inc (AMLX) leadership

    Basma Radwan Ibrahim's questions to Amylyx Pharmaceuticals Inc (AMLX) leadership • Q1 2025

    Question

    Basma Radwan Ibrahim from Leerink Partners, on for Marc Goodman, sought clarification on the 160,000 prevalent patient population for post-bariatric hypoglycemia (PBH). She asked how many are actively seeking treatment and about the new incidence rate, questioning if the 8% rate of development post-surgery is still a valid assumption.

    Answer

    Co-CEO Justin Klee explained that the 160,000 figure represents patients with persistent hypoglycemia despite initial management, a subset of a much larger group who experience some form of hypoglycemia post-surgery. He affirmed that these patients are actively seeking medical attention due to the debilitating nature of the condition. Both Justin Klee and Co-CEO Joshua Cohen confirmed the 8% incidence rate remains a reasonable assumption based on recent surgery data, noting that PBH typically manifests 1-3 years post-procedure.

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    Basma Radwan Ibrahim's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership

    Basma Radwan Ibrahim's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership • Q4 2024

    Question

    Basma Radwan Ibrahim, on for Marc Goodman, asked about the lifecycle strategy for ACP-204, including the potential for a broad dementia-related psychosis indication, and inquired about the awareness goals for the NUPLAZID campaign.

    Answer

    EVP of R&D Elizabeth Thompson stated that the company will pursue separate indications for Alzheimer's disease psychosis and Lewy body dementia psychosis for ACP-204, as the FDA prefers disease-specific data. CCO Tom Garner and CEO Catherine Owen Adams noted the NUPLAZID campaigns are successfully driving patient-doctor conversations, evidenced by increased website traffic and a rise in NBRx market share from 20% to 25%.

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