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    Whitney Ijem • Canaccord Genuity

    Whitney Ijem's questions to Taysha Gene Therapies Inc (TSHA) leadership

    Whitney Ijem's questions to Taysha Gene Therapies Inc (TSHA) leadership • Q1 2025

    Question

    Whitney Ijem of Canaccord Genuity asked for an update on the potential Astellas opt-in, questioning if the timeline was accelerated by recent progress and seeking details on current conversations.

    Answer

    CFO Kamran Alam confirmed that the agreement has specific data-based triggers, and the required pediatric data package is forthcoming. He declined to comment on any specific ongoing discussions with Astellas, stating only that Taysha will execute the agreement as it is written.

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    Whitney Ijem's questions to Taysha Gene Therapies Inc (TSHA) leadership • Q3 2024

    Question

    Whitney Ijem inquired about the level of patient demand for the TSHA-102 trials, especially among adults, to gauge market opportunity. She also requested details on the patient treatment experience, including the immunomodulatory regimen and administration day logistics.

    Answer

    CEO Sean Nolan confirmed significant patient demand for trial slots across both adult and pediatric cohorts. President and Head of R&D Sukumar Nagendran detailed the immunosuppression regimen, noting its duration has been shortened with experience. He contrasted the simple, 10-20 minute intrathecal lumbar puncture with more invasive procedures, highlighting its potential for outpatient administration.

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    Whitney Ijem's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership

    Whitney Ijem's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q1 2025

    Question

    Whitney Ijem from Canaccord Genuity asked about the potential launch trajectory for hypothalamic obesity (HO) in Europe compared to BBS and inquired about expectations for the HO drug label, including any potential restrictions.

    Answer

    David Meeker, CEO, explained that while Europe has advantages like centers of excellence, the HO launch dynamic will be similar to the U.S. due to the high concentration of patients with endocrinologists. He does not expect a BMI requirement in the label, anticipates an age restriction of 4 years and older based on the trial, and noted the company will again try to get hunger included in the indication statement.

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    Whitney Ijem's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q4 2024

    Question

    Whitney Ijem requested an update on the ongoing work to define the prevalence of hypothalamic obesity (HO) from causes other than craniopharyngioma, including congenital forms.

    Answer

    CEO David Meeker explained it is a work in progress but confidence in their initial estimates is growing. He noted that other tumors contribute significantly, the 20-year post-injury survival model may be conservative, and a large pool of patients with HO from other injuries likely remains undiagnosed.

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    Whitney Ijem's questions to Rhythm Pharmaceuticals Inc (RYTM) leadership • Q3 2024

    Question

    Whitney Ijem sought clarification on the basis for the regulatory filing in Japan, asking if it requires the full Japanese cohort to complete one year of follow-up or if an interim analysis is possible.

    Answer

    Chairman, CEO and President David Meeker confirmed that the Japanese filing is contingent on the full 12-patient Japanese cohort completing the one-year follow-up period. The filing will occur after the last Japanese patient finishes the trial at the one-year mark.

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    Whitney Ijem's questions to Intellia Therapeutics Inc (NTLA) leadership

    Whitney Ijem's questions to Intellia Therapeutics Inc (NTLA) leadership • Q3 2024

    Question

    A representative for Whitney Ijem asked for the rationale behind obtaining a U.S. IND for the NTLA-2001 polyneuropathy study, given that the Phase III trial will be conducted entirely ex-U.S.

    Answer

    CMO David Lebwohl explained that obtaining the IND was a strategic step to secure agreement with the U.S. FDA on the trial's design. This ensures the study, although conducted abroad, will be suitable for a future BLA submission in the United States.

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