Keith Tapper • BMO Capital Markets

Question 1

Keith Tapper's questions to Taysha Gene Therapies Inc (TSHA) leadership • Q3 2024

Nov 13, 2024

Question

Keith Tapper asked for the rationale behind advancing to a high-dose cohort before having mature low-dose pediatric data and questioned the translatability of efficacy signals from the adult trial to the pediatric population.

Answer

CEO Sean Nolan explained the decision was based on a favorable benefit/risk profile, supported by preclinical data suggesting incremental benefit at the higher dose and a 2x safety margin in toxicology studies. He expressed confidence that the pattern of early and strengthening functional gains seen in adults is highly translatable and will likely be replicated or even amplified in the more neuroplastic pediatric population.

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Question 2

Keith Tapper's questions to ACADIA Pharmaceuticals Inc (ACAD) leadership • Q3 2024

Nov 6, 2024

Question

Keith Tapper of BMO Capital Markets asked about expectations for Daybue's Canadian launch, including potential revenue and expenses in 2025-26. He also inquired about timelines for Europe and Japan, and the strategy for the next-generation compound NNZ-2591.

Answer

Executive Brendan Teehan stated that for Canada, the focus is on securing reimbursement, with limited private payer coverage expected in 2025. Executive Elizabeth Thompson commented on NNZ-2591, calling it premature to discuss specific clinical plans but noting they are learning from partner Neuren's data to form a Rett-specific strategy. CEO Catherine Owen Adams added that the EU marketing application is planned for Q1 2025 and discussions with Japan's PMDA are ongoing.