Asthika Goonewardene • Truist

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David Chang, CEO, acknowledged that the MRD-positive setting is unique, with minimal disease burden, and that the principles of cell expansion from bulky disease settings may not apply, which was a core hypothesis of the trial. Regarding the data breakdown, he stated they would aim to be informative but cautioned that the futility analysis is based on a small patient cohort of 24.

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President and CEO Dr. David Chang acknowledged that the company must prioritize its programs. He pointed to the upcoming oral presentation of ALLO-316 data at ASCO and stated that the company would provide additional guidance on the program's path forward after the data is presented.

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President and CEO Dr. David Chang acknowledged longer follow-up is needed for clinical outcomes, but initial data will focus on early biomarkers. EVP of R&D and CMO Dr. Zachary Roberts clarified the JCO data, stating that while low disease burden led to a high CR rate, the product is potent enough that patients with bulky disease also achieved durable CRs, indicating it was a "mixing and matching" of patient types.

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Chief Development Officer Judith Klimovsky expressed confidence in the regulatory path for both assets. She stated there is no reason to expect pushback on RINA S with strong data and sees a clear path forward for Epkinley, citing its Breakthrough Therapy Designation and the FDA's acceptance of the SBLA.

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CMO Tahamtan Ahmadi clarified that a non-small cell lung cancer cohort for Rina-S is actively enrolling and that they are not deprioritizing other tumors. He declined to speculate on the competitor's ODAC but expressed confidence in EPKINLY's own data and development path. CDO Judith Klimovsky added that EPKINLY's recent NCCN endorsement is very encouraging.

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Chief Operating Officer Anthony Mancini explained that the EPKINLY launch was initially focused on academic centers but is now seeing a modest shift to community practices, which is still in its early stages. Chief Medical Officer Tahamtan Ahmadi added that the outpatient study is progressing well, with data expected by year-end. He definitively stated that the GEN1046 trial will use a single dose and schedule, regardless of PD-L1 status.

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EVP & CMO Amy Peterson stated the conservative language was purposeful due to a dynamic regulatory environment, but was clear that a statistically significant OS benefit is unequivocal. She confirmed strong interest in developing zanzalutinib as a monotherapy in the adjuvant CRC setting for high-risk patients to potentially prevent disease recurrence.

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EVP of Commercial P.J. Haley stated that a significant patient bolus is not expected for the NET launch. Chief Medical Officer Amy Peterson explained the STELLAR-303 modification to dual primary endpoints was driven by data maturity, allowing for a simultaneous analysis of the ITT population, which could benefit a larger patient group, rather than being a move to alter statistical hurdles.

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President and CEO Michael Morrissey dismissed direct comparisons, emphasizing that Exelixis is focused on running large, global, randomized pivotal trials for zanzalintinib against contemporary standards of care. He stated that positive data from these trials, not speculative comparisons of small datasets, will be the ultimate driver for label-enabling efforts and commercial success.

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President and CEO Michael Morrissey stated that while he could not speak for Merck, the extensive diligence process took place over many months. He emphasized the value of partnering with a leader like Merck, which validates zanzalintinib and brings significant expertise in executing large pivotal trials.

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An executive stated the internal iCTC handles the majority of manufacturing volume. EVP of Medical Affairs Dr. Brian Gastman explained that while guidance asks for a reasonable amount of tumor, the focus is on best practices for handling and preparation, not just volume, to accommodate surgeons with varying experience levels.

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Interim CEO Frederick Vogt estimated that a very low number, likely 10% or less, have reached steady state. Chief Commercial Officer Dan Kirby added that even the most active centers (those with 10+ infusions) are not considered saturated, as the strategy is to drive more community referrals to these experienced sites.

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Interim CEO Frederick Vogt explained that it is a combination of both factors. Early learnings from helping struggling centers improve are now being applied to train new ATCs, enabling them to avoid common mistakes. The company uses performance scorecards and a peer-to-peer support team to build momentum across the entire network.

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CEO Ugur Sahin clarified that the rate of stomatitis in the combination was very comparable to that observed with the BNT325 ADC as a monotherapy. He found this encouraging as it suggested no additional or additive toxicity from combining the two agents.

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CMO Özlem Türeci and CEO Ugur Sahin clarified the trial design. The Phase II dose-justification portion involves ~40 patients, while the Phase III component will enroll over 940 patients. Sahin explained that, following FDA discussions, they are treating squamous and non-squamous histologies as two separate indications in the analysis due to recent data showing different outcomes for some therapies in these populations.

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Dr. Allen Yang, Chief Medical Officer, stated the plan is to conduct a primary analysis on the combined patient population to accelerate market access. He confirmed FDA discussions have occurred but could not disclose details. An executive explained the Pfizer deal rationale is partly empiric, combining two active drugs, with the potential for synergistic immune system effects that they are eager to explore.

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CMO Dimitry Nuyten identified the CheckMate-214 study (ipi-nivo) as the relevant benchmark, noting the combination's key advantage could be reducing the high primary progression rate seen with ipi-nivo. COO Jennifer Jarrett added that this potential to improve the front-end of the PFS curve is what attracted AstraZeneca to the collaboration.

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CEO Terry Rosen explained that the readout for the second etrumadenant cohort is expected sometime in 2025, as the data is not yet mature. Regarding combinations, he affirmed that pairing a HIF-2 alpha inhibitor with anti-PD-1 or anti-CTLA4 is a logical strategy and mentioned that a second registrational trial for casdatifan in the frontline setting will be announced soon.

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