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    Daina Graybosch • Leerink Partners

    Daina Graybosch's questions to Biontech SE (BNTX) leadership

    Daina Graybosch's questions to Biontech SE (BNTX) leadership • Q2 2025

    Question

    Daina Graybosch asked about the strategy for BNT327 in frontline triple-negative breast cancer (TNBC), particularly in light of the success of TROP2 ADCs, and whether a trial could proceed without a TROP2 ADC in the active or control arm.

    Answer

    CEO Ugur Sahin explained that TNBC presents several opportunities for BNT327, citing encouraging PFS and OS data from combinations with chemotherapy. He noted that combining with ADCs, such as their TROP2 or HER3 candidates, could further enhance efficacy and confirmed a combination study is currently underway.

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    Daina Graybosch's questions to Biontech SE (BNTX) leadership • Q1 2025

    Question

    Daina Graybosch asked about the anticipated outcome of the CDC's ACIP vote on COVID-19 boosters and the potential sales impact if the U.S. recommendation is narrowed to a risk-based approach.

    Answer

    Chief Strategy Officer Ryan Richardson noted that the majority of U.S. vaccinations already target the 65+ and immunocompromised groups, so their base scenario of around 20% vaccination rates remains intact. CFO Jens Holstein added that similar risk-based policies exist in other regions and that the final impact is hard to predict as some individuals get vaccinated regardless of official recommendations.

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    Daina Graybosch's questions to Biontech SE (BNTX) leadership • Q4 2024

    Question

    Daina Graybosch of Leerink Partners inquired about the timeline for significant legal IP cases and the context for upcoming FixVac data in melanoma, given the iNeST trial results in a similar setting.

    Answer

    CFO Jens Holstein and CSO Ryan Richardson expressed confidence in their IP portfolio, directing investors to the 20-F filing for details on legal disputes. Regarding the vaccine data, CMO Özlem Türeci and CEO Ugur Sahin explained that the off-the-shelf FixVac can be administered immediately, a critical advantage in rapidly progressing metastatic melanoma compared to the personalized iNeST vaccine. They reiterated their strategy of focusing iNeST on the adjuvant setting where there is more time for an immune response to develop.

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    Daina Graybosch's questions to Biontech SE (BNTX) leadership • Q3 2024

    Question

    Daina Graybosch asked about the VEGF PD-L1 bispecific, BNT327, noting its similar outcomes to a competitor's PD-1 bispecific and questioning if this was expected, what it implies about the mechanism, and where BNT327 could be differentiated.

    Answer

    CEO Dr. Ugur Sahin explained that while both bispecifics neutralize VEGF and PD-1/PD-L1 interaction, BNT327 targets PD-L1, which could potentially enrich it in the tumor microenvironment. He acknowledged that data in overlapping trials looks similar but suggested it's too early to validate if the mechanistic difference translates to better response rates, particularly in PD-L1 positive tumors, though a slight trend exists.

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    Daina Graybosch's questions to Merck & Co Inc (MRK) leadership

    Daina Graybosch's questions to Merck & Co Inc (MRK) leadership • Q2 2025

    Question

    Daina Graybosch of Leerink Partners inquired about the Phase 2 CADENCE trial for Winrevir, asking about the clinical bar for success for its primary outcomes and whether a Phase 3 trial would require hard cardiovascular outcomes for registration.

    Answer

    Dr. Dean Li, President of Merck Research Labs, responded that the most important signal from the trial would be a substantial impact on pulmonary vascular resistance (PVR). He also stated his expectation that the FDA would likely require a Phase 3 trial to demonstrate effectiveness in this broader patient population.

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    Daina Graybosch's questions to Merck & Co Inc (MRK) leadership • Q2 2025

    Question

    Daina Graybosch of Leerink Partners asked about the upcoming Phase 2 CADENCE trial for Winrevir, seeking clarity on the clinical bar for success for its primary endpoints and whether a future Phase 3 trial would need to show hard cardiovascular outcomes for registration in the HFpEF indication.

    Answer

    Dr. Dean Li, President of Merck Research Laboratories, responded that the trial focuses on a heart failure population with PAH-like physiology. He emphasized that the most critical signal would be a substantial impact on PVR (pulmonary vascular resistance). Dr. Li stated his expectation, pending data, is that the FDA would likely require a Phase 3 trial to demonstrate effectiveness in this broader patient group.

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    Daina Graybosch's questions to Merck & Co Inc (MRK) leadership • Q4 2024

    Question

    Daina Graybosch inquired about the early-stopped HYPERION trial for WINREVAIR, asking what outcomes data could be provided and whether it would be sufficient to support use in less severe patients, where toxicity concerns might be higher.

    Answer

    Dr. Dean Li, President of Merck Research Labs, emphasized the goal of building an 'evidentiary wall' for WINREVAIR. He highlighted that the ZENITH trial data on hard outcomes would be presented at ACC '25. For HYPERION, he explained it was stopped early due to a loss of clinical equipoise, but the study remains blinded, so data will be shared later. He also noted that the long-term safety experience remains well within the product's label.

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    Daina Graybosch's questions to Merck & Co Inc (MRK) leadership • Q3 2024

    Question

    Daina Graybosch of Leerink Partners questioned the pneumococcal vaccine opportunity, asking about the incremental market size from the CAPVAXIVE label expansion to age 50 and what to look for in the upcoming MMWR publication.

    Answer

    Dr. Dean Li emphasized CAPVAXIVE's superior profile, with its 21-valent formula providing 85% adult protection versus a competitor's 54%, which he believes drove the ACIP's recommendation. CFO Caroline Litchfield quantified the expanded opportunity, noting the 50-64 age group adds 60 million people to the addressable market in the United States, bringing the total over-50 population to 120 million.

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    Daina Graybosch's questions to Arcus Biosciences Inc (RCUS) leadership

    Daina Graybosch's questions to Arcus Biosciences Inc (RCUS) leadership • Q1 2025

    Question

    Daina Graybosch asked about the TIGIT program, questioning if Arcus is underinvesting relative to AstraZeneca, and inquired about the efficacy bar for casdatifan monotherapy to potentially compete with TKIs in a head-to-head trial.

    Answer

    President Juan Jaen defended their TIGIT strategy, stating they feel good about their bets in large markets like lung and gastric cancer and have other opportunities teed up pending positive Phase III results. Regarding casdatifan, CEO Terry Rosen and President Juan Jaen explained that while early cohorts are exploratory, an ORR in line with the high-teens to 40% range of TKIs, combined with a better safety profile, would be very exciting for clinicians.

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    Daina Graybosch's questions to Arcus Biosciences Inc (RCUS) leadership • Q3 2024

    Question

    Daina Graybosch of Leerink Partners asked about Arcus's strategy for managing treatment exposure and toxicity in its upcoming combination trials, specifically PEAK-1 with cabozantinib and the trial with AstraZeneca's volrustomig.

    Answer

    CMO Dimitry Nuyten explained that for PEAK-1, the lack of overlapping toxicities between casdatifan and cabozantinib simplifies management. For the AstraZeneca trial, he noted that investigators are experienced with managing ipi-nivo-like toxicities, and the non-overlapping profiles will again make dose modification guidance straightforward.

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    Daina Graybosch's questions to Arcus Biosciences Inc (RCUS) leadership • Q2 2024

    Question

    Daina Graybosch of Leerink Partners requested details on the patient demographics and regional enrollment for the ARC-10 trial to help set expectations and facilitate comparisons with other anti-TIGIT studies.

    Answer

    CEO Terry Rosen framed the upcoming ARC-10 data as an important and positive dataset for the anti-TIGIT field. CMO Dimitry Nuyten clarified the trial enrolled about 40 patients each in the domvanalimab+zimberelimab and zimberelimab monotherapy arms, and 20 in a chemotherapy arm. He noted it was conducted ex-U.S. but is comparable to other first-line studies, with the chemo arm serving as a benchmark.

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    Daina Graybosch's questions to Arcus Biosciences Inc (RCUS) leadership • Q1 2024

    Question

    An analyst from Leerink Partners, on for Daina Graybosch, asked how Arcus's HIF-2 alpha inhibitor, casdatifan, is differentiated from Novartis's molecule and if Novartis's decision to discontinue its program has any read-through. He also asked how recent data for etrumadenant might change its perceived opportunity relative to quemliclustat and if new trials for etrumadenant are planned.

    Answer

    President Juan Jaen stated that in-vitro evaluations suggest the Novartis molecule is about an order of magnitude weaker than casdatifan. CEO Terry Rosen added there is zero read-through from the discontinuation, emphasizing molecule quality. Regarding etrumadenant and quemliclustat, Rosen said both are viewed as having great potential and that combining them could be contemplated in the future. He confirmed they expect to do more with etrumadenant following the strong ARC-9 data, but plans are still being finalized with Gilead and the FDA. COO Jennifer Jarrett highlighted that ARC-9's acceptance as an oral presentation at ASCO signals its significance.

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    Daina Graybosch's questions to Gilead Sciences Inc (GILD) leadership

    Daina Graybosch's questions to Gilead Sciences Inc (GILD) leadership • Q1 2025

    Question

    Daina Graybosch inquired about the process and timeline for adding lenacapavir to the USPSTF mandate for coverage without cost-sharing and the potential revenue uplift from such a designation.

    Answer

    Chief Commercial Officer Johanna Mercier explained that while they will pursue the USPSTF update, their launch plans for the first 6-12 months do not assume it will be in place. She expressed confidence that the transformative nature of lenacapavir will drive access through standard channels, similar to past launches. The mandate is viewed as a 'nice to have' that would provide a future tailwind rather than a prerequisite for initial success.

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    Daina Graybosch's questions to Gilead Sciences Inc (GILD) leadership • Q4 2024

    Question

    Daina Graybosch asked new Chief Medical Officer Dietmar Berger for his perspective on the competitiveness of Gilead's late-stage oncology portfolio, specifically focusing on Trodelvy and the TIGIT inhibitor domvanelumab.

    Answer

    CMO Dietmar Berger expressed confidence in the portfolio. He highlighted Trodelvy's upcoming Phase III readouts and its unique overall survival benefit in key cancers. For TIGIT, he noted its potential for differentiation due to its Fc-silent design but stressed that the ongoing Phase III trials will ultimately define its path forward.

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    Daina Graybosch's questions to Gilead Sciences Inc (GILD) leadership • Q3 2024

    Question

    Daina Graybosch of Leerink Partners inquired about the gating factors for the anito-cel regulatory filing and what will be required to expand the CAR-T market in multiple myeloma beyond the current low penetration rates.

    Answer

    An executive, likely EVP of Kite Cindy Perettie, explained that while the FDA typically requires 12 months of data for filing, Gilead plans to discuss the review timeline with the agency based on anito-cel's differentiated safety profile. To grow the market, she noted that the ongoing work to overcome reimbursement and access challenges in community practices for lymphoma will be directly applicable to expanding anito-cel adoption in multiple myeloma.

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