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    Silvan Tuerkcan • Citizens JMP

    Silvan Tuerkcan's questions to Taysha Gene Therapies Inc (TSHA) leadership

    Silvan Tuerkcan's questions to Taysha Gene Therapies Inc (TSHA) leadership • Q1 2025

    Question

    Silvan Tuerkcan of Citizens JMP sought confirmation that the FDA specifically agreed to a primary endpoint that is objective and not effort-based.

    Answer

    CEO Sean Nolan explicitly confirmed, 'It's not effort-based. It is objective, and it's very clinically meaningful.' He reiterated that the endpoint is based on gains of function or restoration of lost function, which is meaningful to patients, clinicians, and payers, and that data collected in Part A will be predictive for the pivotal Part B trial.

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    Silvan Tuerkcan's questions to Taysha Gene Therapies Inc (TSHA) leadership • Q3 2024

    Question

    Silvan Tuerkcan inquired about the dose equivalency between Taysha's TSHA-102 and Neurogene's therapy, considering the different administration routes and Taysha's recent biodistribution data.

    Answer

    CEO Sean Nolan referenced recent ESGCT data from 29 non-human primates, which showed that Taysha's intrathecal delivery achieves widespread biodistribution comparable to direct-to-brain administration. He and President Sukumar Nagendran attributed the lower effective dose to the higher transduction efficiency of their self-complementary vector design, noting both delivery routes have now shown proof of concept.

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    Silvan Tuerkcan's questions to Taysha Gene Therapies Inc (TSHA) leadership • Q2 2024

    Question

    Silvan Tuerkcan asked for more details on the previously reported SAE related to the immunosuppressive regimen and inquired when the safety committee might eliminate the 42-day dosing stagger.

    Answer

    CEO Sean Nolan confirmed the SAE was resolved and deemed not treatment-related, allowing the program to advance. Regarding the dosing stagger, he explained that any change would require a discussion with the IDMC after sufficient safety data is collected, suggesting it's a future possibility. President and Head of R&D, Sukumar Nagendran, added that for intrathecal delivery, regulators have shown flexibility on staggers when the benefit-risk profile is appropriate.

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    Silvan Tuerkcan's questions to Exelixis Inc (EXEL) leadership

    Silvan Tuerkcan's questions to Exelixis Inc (EXEL) leadership • Q1 2025

    Question

    Silvan Tuerkcan asked about Exelixis's business development appetite in the current market environment and whether any roadblocks exist for potential transactions.

    Answer

    President and CEO Michael Morrissey affirmed that the company is 'open for business' and actively seeking high-conviction assets in GU and GI oncology. He stressed the focus is on assets that can improve the standard of care, not on 'cheap' but risky deals. He indicated the key factors remain finding the right asset at the right time and valuation, with no specific roadblocks mentioned.

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    Silvan Tuerkcan's questions to Exelixis Inc (EXEL) leadership • Q3 2024

    Question

    Silvan Tuerkcan asked for an update on Exelixis's early-stage synthetic lethality pipeline assets, including expected data timelines and the company's view on the competitive landscape.

    Answer

    Chief Scientific Officer Dana Aftab and Chief Medical Officer Amy Peterson responded. Aftab highlighted that XL-309 and XL-495 are substantially differentiated from competitors due to advantages in pharmacokinetics (PK) and selectivity. Peterson added that the development team is intensely focused on advancing these best-in-class assets, which have the potential to expand beyond current treatment paradigms.

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    Silvan Tuerkcan's questions to Intellia Therapeutics Inc (NTLA) leadership

    Silvan Tuerkcan's questions to Intellia Therapeutics Inc (NTLA) leadership • Q4 2024

    Question

    Silvan Tuerkcan asked about the upcoming presentation of quality of life data in HAE, seeking to understand what might be shown and how it could clarify the market opportunity.

    Answer

    CMO David Lebwohl did not disclose specific results but indicated that a therapy that is easy to administer and subsequently frees patients from disease events would be 'very favorable' from a quality of life perspective. He encouraged listeners to watch for the presentation.

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    Silvan Tuerkcan's questions to Intellia Therapeutics Inc (NTLA) leadership • Q3 2024

    Question

    Silvan Tuerkcan asked about the MAGNITUDE-2 trial, specifically when it would be initiated in the U.S. and what the eventual split of U.S. versus ex-U.S. patients would be.

    Answer

    CEO John Leonard clarified that the study will be conducted entirely outside the United States. This approach allows for a placebo-controlled trial design, which was developed in agreement with the U.S. FDA, who will accept the ex-U.S. data for a potential BLA filing.

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