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    Boobalan Pachaiyappan • ROTH Capital Partners

    Boobalan Pachaiyappan's questions to Capricor Therapeutics Inc (CAPR) leadership

    Boobalan Pachaiyappan's questions to Capricor Therapeutics Inc (CAPR) leadership • Q1 2025

    Question

    Maanasa Ramesh, on behalf of Boobalan Pachaiyappan from ROTH Capital, asked about the ideal patient profile for deramiocel based on payer research, progress with Japanese regulators, and the composition of the AdCom committee.

    Answer

    CEO Linda Marbán specified the target patient profile for the label would be the presence of scar tissue (LGE) in the heart or an ejection fraction of 55% or less. She noted that Capricor is actively working with a CRO in Japan with plans for PMDA meetings later this year or early next. Regarding the AdCom, she stated the panelist list is public and the company is preparing with mock panels of experts with similar profiles.

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    Boobalan Pachaiyappan's questions to Verona Pharma PLC (VRNA) leadership

    Boobalan Pachaiyappan's questions to Verona Pharma PLC (VRNA) leadership • Q1 2025

    Question

    Boobalan Pachaiyappan asked about the price stability of Ohtuvayre for 2025 amid inflation concerns and sought high-level details on the upcoming Phase IIb fixed-dose combination study, particularly regarding the FEV1 efficacy markers.

    Answer

    CEO David Zaccardelli confirmed that the company sees the price of Ohtuvayre as stable through 2025. Chief Development Officer Dr. Tara Rheault explained that for the Phase IIb fixed-dose study, the company will measure lung function over the dosing interval. She noted that while pre-dose trough FEV1 will be measured, it is not expected to be the primary endpoint, similar to the approach taken with Ohtuvayre, due to the operational difficulty of measuring it for a twice-daily drug.

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    Boobalan Pachaiyappan's questions to Verona Pharma PLC (VRNA) leadership • Q1 2025

    Question

    Boobalan Pachaiyappan of ROTH Capital Partners asked about the price stability of Ohtuvayre for 2025 and sought details on the planned Phase IIb fixed-dose combination study, particularly the FEV1 efficacy marker.

    Answer

    CEO David Zaccardelli confirmed that the price for Ohtuvayre is expected to remain stable through 2025. Dr. Tara Rheault, Chief Development Officer, explained that for the fixed-dose combination study, the primary endpoint is unlikely to be pre-dose trough FEV1 due to the operational challenges of measuring it for a twice-daily drug. Instead, the study will focus on lung function over the full 12-hour dosing interval.

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    Boobalan Pachaiyappan's questions to Verona Pharma PLC (VRNA) leadership • Q4 2024

    Question

    Boobalan Pachaiyappan asked about the real-world refill process, including any required testing, and inquired about the real-world side-effect profile, specifically regarding psychiatric events listed on the FDA label.

    Answer

    Chief Commercial Officer Chris Martin described the refill process as highly organized, with specialty pharmacy partners proactively contacting patients to ensure adherence. Executive David Zaccardelli addressed safety, stating that the company's active pharmacovigilance program has not identified any side effects inconsistent with the product's label. He confirmed the real-world side-effect profile is consistent with what was observed in clinical trials.

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    Boobalan Pachaiyappan's questions to Verona Pharma PLC (VRNA) leadership • Q3 2024

    Question

    Boobalan Pachaiyappan asked about potential headwinds from the newly approved Dupixent, especially in the triple-therapy patient segment. He also inquired about a separate Phase II study on sputum markers and how its results would be integrated into the company's broader strategy.

    Answer

    Executive David Zaccardelli stated they do not see Dupixent as a headwind, as it targets a narrow patient sub-population and highlights the overall unmet need for new therapies. He and Chief Development Officer Dr. Tara Rheault explained the sputum study is a small, mechanistic trial designed to further characterize Ohtuvayre's anti-inflammatory pharmacology, building on previous data and the strong ENHANCE trial results.

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