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    Madison El-Saadi • B.Riley Securities

    Madison El-Saadi's questions to Capricor Therapeutics Inc (CAPR) leadership

    Madison El-Saadi's questions to Capricor Therapeutics Inc (CAPR) leadership • Q2 2025

    Question

    Madison El-Saadi inquired about any informal communications with the FDA following the CRL and whether Capricor expects a decision on the proposed primary endpoint change for HOPE-three during the Type A meeting.

    Answer

    CEO Linda Marbán confirmed a brief, informal meeting occurred with the FDA primarily to align on timelines, but it did not involve clinical or statistical reviewers. She affirmed that getting clarity on the LVEF primary endpoint for HOPE-three is a key objective for the upcoming formal Type A meeting.

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    Madison El-Saadi's questions to WAVE Life Sciences Ltd (WVE) leadership

    Madison El-Saadi's questions to WAVE Life Sciences Ltd (WVE) leadership • Q2 2025

    Question

    Madison El-Saadi of B.Riley Securities asked if subsequent dosing cohorts for WVE-006 (AATD) have been initiated and what triggers might be for further dosing or expansion. For the DMD program, she inquired about enrollment in the open-label extension and the treatment duration needed before the NDA submission.

    Answer

    President & CEO Paul Bolno explained that decisions on subsequent WVE-006 cohorts will be informed by the upcoming 200 mg multi-dose and 400 mg single-dose data, which will clarify the PK/PD relationship and dosing needs. For the DMD program, he confirmed patients remain on study in the extension and that there is no change to the planned 2026 NDA filing timeline, indicating progress is on track.

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    Madison El-Saadi's questions to WAVE Life Sciences Ltd (WVE) leadership • Q4 2024

    Question

    Madison El-Saadi of B. Riley Securities inquired about plans for the upcoming MDA conference, asked for a characterization of previously reported NfL data for WVE-003, and sought a comparison of WVE-003's profile against emerging exon 1-targeted candidates for Huntington's disease.

    Answer

    President and CEO Paul Bolno stated the full DMD data and regulatory update will be released by month-end, not timed for the MDA conference. Regarding Huntington's, he reiterated that NfL has not correlated with clinical outcomes in past studies and was not a focus of FDA discussions. He also questioned the specificity of the exon 1 target, noting that some supportive data for that approach was actually generated using Wave's own allele-specific oligonucleotides.

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