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    Gil Blum • Needham & Company

    Gil Blum's questions to Immunocore Holdings PLC (IMCR) leadership

    Gil Blum's questions to Immunocore Holdings PLC (IMCR) leadership • Q2 2025

    Question

    Gil Blum from Needham & Company inquired about the clinical trial design for PRISMEL, specifically how patients on the discontinued dose will be handled, and asked about the company's timeline to reach profitability.

    Answer

    David Berman, EVP of R&D, clarified that patients on the dropped dose will continue on it, though the IDMC may recommend a switch, and they will not be included in the final ITT analysis. Travis Coy, CFO, stated it is too early to discuss profitability due to ongoing investments in three Phase III trials and an expected increase in R&D expenses, despite strong ChemTrak growth.

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    Gil Blum's questions to Immunocore Holdings PLC (IMCR) leadership • Q4 2024

    Question

    Representing Gil Blum of Needham & Company, an analyst asked if the reimbursement challenges seen with KIMMTRAK in Europe are expected to be similar for brenetafusp, or if they are specific to KIMMTRAK's indication.

    Answer

    CEO Bahija Jallal highlighted the company's successes, including 14 country approvals and overturning the NICE decision in the U.K., while acknowledging the generally challenging European environment. Ralph Torbay, Head of Commercial, added that this is an industry-wide issue. Bahija Jallal concluded that securing an overall survival (OS) endpoint for brenetafusp, similar to KIMMTRAK, would likely facilitate the reimbursement process.

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    Gil Blum's questions to Taysha Gene Therapies Inc (TSHA) leadership

    Gil Blum's questions to Taysha Gene Therapies Inc (TSHA) leadership • Q1 2025

    Question

    Gil Blum of Needham & Co. questioned if the FDA might still provide significant feedback on the study protocol and statistical analysis plan (SAP) after the 30-day review period, despite the positive alignment.

    Answer

    CEO Sean Nolan stated that a 'showstopper' is highly unlikely, as the purpose of an end-of-phase meeting is to resolve misalignments, which they don't have. President and Head of R&D Sukumar Nagendran added that the FDA would have requested further review before this stage if they were uncomfortable, making significant new comments improbable, though minor correspondence is possible.

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    Gil Blum's questions to Taysha Gene Therapies Inc (TSHA) leadership • Q3 2024

    Question

    Gil Blum asked if prior experience with Zolgensma influenced the successful CMC comparability demonstration and questioned the feasibility of a randomized trial in adults versus using a natural history control.

    Answer

    CEO Sean Nolan confirmed that learnings from Zolgensma, particularly around maximizing product purity via downstream process improvements, were key to the successful comparability. He stated that CMC is now off the critical path. Regarding trial design, he explained that due to disease heterogeneity, using the patient as their own control is the optimal approach being discussed with the FDA.

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    Gil Blum's questions to Taysha Gene Therapies Inc (TSHA) leadership • Q2 2024

    Question

    Gil Blum questioned whether a potential clinical endpoint could be dependent on a patient's baseline condition, such as their seizure burden.

    Answer

    CEO Sean Nolan described it as an "evolving situation." He suggested that while a primary or co-primary endpoint might be standardized (e.g., motor function), the restoration of a lost function, like seizure reduction, would be highly impactful supportive data for regulators and payers. President and Head of R&D, Sukumar Nagendran, added that ongoing analysis of natural history data will help inform the Part B trial design to best assess these varied clinical impacts.

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    Gil Blum's questions to Sarepta Therapeutics Inc (SRPT) leadership

    Gil Blum's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q1 2025

    Question

    Gil Blum asked if there was any commonality (e.g., ambulatory status) among the patients who paused treatment after the recent safety event.

    Answer

    President and CEO Douglas Ingram clarified that there was no commonality other than timing. He explained that the patients who paused were scheduled for infusion in March, immediately following the late February announcement of the safety event, and simply needed more time and information before proceeding.

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    Gil Blum's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q4 2024

    Question

    Gil Blum from Needham & Company inquired about the planned move to suspension manufacturing, asking about potential cost savings and the broad applicability of this process to other gene therapy programs beyond DMD.

    Answer

    CEO Douglas Ingram stated the goal is to transition almost all gene therapy programs to suspension, with SRP-9003 being a likely exception due to timing. He noted the move could yield significant efficiencies, potentially 5x or more, which could drive margins well over 90%. The plan is to complete GMP runs and begin the bridging study in 2025, targeting a full transition to suspension in 2027, aligning with global expansion plans.

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    Gil Blum's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q3 2024

    Question

    Gil Blum of Needham & Company asked about the future of the PMO franchise, including life cycle management plans, and questioned if the discontinuation of SRP-5051 signaled a strategic shift away from exon-skipping therapies.

    Answer

    President and CEO Doug Ingram firmly stated that Sarepta is not moving away from exon skippers and is exploring other modalities. He emphasized the significant and proven benefit of the current PMOs, supported by strong real-world evidence and a laudable safety profile, which sets a very high bar for any potential alternatives.

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    Gil Blum's questions to Sarepta Therapeutics Inc (SRPT) leadership • Q2 2024

    Question

    Gil Blum asked if the perceived launch bottleneck ultimately boils down to the number of treating physicians available at each infusion center.

    Answer

    CEO Douglas Ingram reiterated his consistent message that there are no bottlenecks to solve. He stated the company has a successful launch curve with a significant number of sites and treating physicians, extraordinary demand, strong payer interactions, and ample manufacturing capacity. He concluded that the company is in great shape to execute a successful launch and achieve its financial targets.

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    Gil Blum's questions to Amicus Therapeutics Inc (FOLD) leadership

    Gil Blum's questions to Amicus Therapeutics Inc (FOLD) leadership • Q1 2025

    Question

    Gil Blum of Needham & Company asked about future investments needed to manage tariff impacts beyond 2025 and the financial effect of a weakening U.S. dollar.

    Answer

    President and CEO Bradley Campbell stated that he does not foresee significant new investments to manage tariffs, citing the company's proactive supply chain diversification, including moving manufacturing to Ireland and onshoring some drug product to the U.S. He also noted that with a majority of revenue coming from ex-U.S. markets, a weakening dollar generally provides a top-line benefit from favorable foreign exchange rates.

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    Gil Blum's questions to Amicus Therapeutics Inc (FOLD) leadership • Q3 2024

    Question

    Gil Blum asked for Amicus's perspective on recent FDA feedback about potential accelerated approval pathways for genetic medicines in Fabry disease and whether this could accelerate their own internal program.

    Answer

    President and CEO Bradley Campbell responded that he views other gene therapies in development as primarily targeting patients with non-amenable mutations, which does not compete with Galafold. While he finds the FDA's regulatory flexibility exciting, he reiterated that Amicus's own program is still in early stages, a lower priority, and is also focused on the non-amenable population for the future.

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