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    Matthew BieglerOppenheimer & Co. Inc.

    Matthew Biegler's questions to Allogene Therapeutics Inc (ALLO) leadership

    Matthew Biegler's questions to Allogene Therapeutics Inc (ALLO) leadership • Q2 2025

    Question

    Matthew Biegler asked if the company's perspective on the importance of cell expansion has changed for the lower tumor burden MRD setting, given that enhanced expansion was a key rationale for the now-discontinued FCA arm.

    Answer

    David Chang, CEO, clarified that their thinking has not changed. The company always recognized the MRD setting's low antigen environment was unique, which is why the trial was designed from the start with both FC and FCA arms to test different expansion hypotheses. He noted that unplanned data showing MRD conversion with the FC arm provided confidence to proceed with that regimen alone.

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    Matthew Biegler's questions to Allogene Therapeutics Inc (ALLO) leadership • Q1 2025

    Question

    Matthew Biegler of Oppenheimer questioned Allogene's strategy for its autoimmune program, asking if the company would consider partnering ALLO-329 to manage cash burn.

    Answer

    President and CEO Dr. David Chang confirmed that protecting the cash runway is a top priority in the current market. He stated that the company is "very willing to partner and derisk the autoimmune program," particularly as it is outside their core therapeutic area of expertise. He noted any reasonable deal would be considered.

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    Matthew Biegler's questions to Allogene Therapeutics Inc (ALLO) leadership • Q4 2024

    Question

    Matthew Biegler asked about the strategic trade-off for the RESOLUTION trial, specifically how much efficacy the company might be willing to sacrifice to achieve a no-lymphodepletion regimen for ALLO-329.

    Answer

    President and CEO Dr. David Chang described eliminating lymphodepletion as a "big, big game changer" that would significantly expand the addressable patient population to those with moderate disease. However, he also emphasized that even achieving a milder lymphodepletion regimen (without fludarabine) would be considered a "significant win" for the program.

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    Matthew Biegler's questions to Fulcrum Therapeutics Inc (FULC) leadership

    Matthew Biegler's questions to Fulcrum Therapeutics Inc (FULC) leadership • Q1 2025

    Question

    Matthew Biegler from Oppenheimer noted the baseline fetal hemoglobin (HbF) of ~7.6% was higher than anticipated for a severe patient population. He asked if this sample was representative and whether pociredir would be equally or more effective in patients with higher baseline HbF. He also questioned the reason for tightening the data release guidance from 'mid-year' to 'early Q3'.

    Answer

    Executive Alexander Sapir clarified that the baseline HbF was disclosed to allay investor concerns that it might be too low to show a meaningful increase. Iain Fraser, Head of Development, added that while this is a small sample, there is currently no reason to believe baseline HbF determines the response to pociredir. Regarding the timeline, Mr. Sapir stated the adjustment was due to trial execution, allowing them to report on a larger cohort of 16 patients.

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    Matthew Biegler's questions to Fulcrum Therapeutics Inc (FULC) leadership • Q4 2024

    Question

    Matthew Biegler of Oppenheimer & Co. Inc. requested more detail on the type of data expected from the pociredir readouts mid-year and year-end, specifically asking if it would be mature enough to show any early data on vaso-occlusive crises (VOCs).

    Answer

    CEO Alexander Sapir confirmed the data release will include HbF levels, other biomarkers, and comprehensive safety data. He cautioned that observing a significant reduction in VOCs is unlikely given the short 3-month study duration. Executive Iain Fraser added that while they will report any on-study VOCs descriptively, the study is not powered for that endpoint, but they will have more granular data on patients' baseline VOC frequency.

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    Matthew Biegler's questions to Fulcrum Therapeutics Inc (FULC) leadership • Q3 2024

    Question

    Matthew Biegler of Oppenheimer inquired about Fulcrum's high-level strategy for its platform technology, the decision-making process for keeping assets wholly-owned versus partnering, and the future therapeutic area focus.

    Answer

    Executive Alexander Sapir explained that the company's most advanced preclinical program in inherited aplastic anemias, which came from the Camp4 deal, will be progressed internally for the time being, retaining global rights. He noted that ex-U.S. licensing remains a future option, similar to the Sanofi deal for losmapimod, but the current focus is on internal discovery efforts. Executive Iain Fraser concurred with the summary.

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    Matthew Biegler's questions to Fulcrum Therapeutics Inc (FULC) leadership • Q2 2024

    Question

    Matthew Biegler asked if the FDA had requested more data on losmapimod's mechanism of action, such as DUX4 reduction biomarkers, and whether the updated timeline for REACH data was a revision or simply fine-tuning of previous guidance.

    Answer

    Executive Iain Fraser responded that the FDA's focus has been on functional endpoints, not biomarkers, and that the company has not received requests for more mechanism of action data. CEO Alexander Sapir clarified that the updated REACH data timeline of 'by the end of October' is simply 'fine-tuning' as the company gains more certainty with the last patient visits approaching.

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    Matthew Biegler's questions to Gilead Sciences Inc (GILD) leadership

    Matthew Biegler's questions to Gilead Sciences Inc (GILD) leadership • Q1 2025

    Question

    Matthew Biegler asked if Trodelvy's decreased demand was related to competitive pressure from recent approvals and requested a breakdown of the patient mix between triple-negative and HR-positive breast cancer.

    Answer

    Chief Commercial Officer Johanna Mercier stated that they have not seen an impact from new market entrants. She clarified Trodelvy's distinct positioning: it is the ADC of choice in second-line metastatic triple-negative breast cancer and in later (fourth) lines for HR-positive/HER2-negative disease, differentiating it from other ADCs used in earlier lines of therapy.

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    Matthew Biegler's questions to Gilead Sciences Inc (GILD) leadership • Q3 2024

    Question

    Matthew Biegler of Oppenheimer & Co. Inc. asked about the scale of the market opportunity for Trodelvy in frontline triple-negative breast cancer (TNBC), ahead of the upcoming ASCENT-03 data.

    Answer

    Johanna Mercier, Chief Commercial Officer, stated that the frontline TNBC market is significantly larger than later-line settings, estimating it to be 'about double' in size. She noted the market is split between PD-L1 negative and positive patients. Mercier emphasized that demonstrating an overall survival benefit in this setting would be incredibly powerful, building on Trodelvy's established standard-of-care position in second-line plus.

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    Matthew Biegler's questions to Arvinas Inc (ARVN) leadership

    Matthew Biegler's questions to Arvinas Inc (ARVN) leadership • Q3 2024

    Question

    Matthew Biegler of Oppenheimer asked about the statistical plan for VERITAC-2, specifically if it involves hierarchical testing, and whether a hazard ratio of 0.7 would be sufficient for an all-comers label.

    Answer

    CMO Noah Berkowitz confirmed that VERITAC-2 has two co-primary endpoints (ESR1 mutant and ITT population) and the company can succeed on either. While not commenting on a specific hazard ratio, he noted that they expect to achieve a better hazard ratio in the ESR1 mutant population compared to the overall ITT population.

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