Jeffrey Jones • Oppenheimer & Co. Inc.

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CEO Michael Rossi explained that the new construct aims to increase tumor affinity and duration. A bridging study will be conducted to demonstrate the safety of the new proprietary linker before starting Part B. He anticipates this bridging study will be conducted in the second half of 2025, with potential completion early in 2026.

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CEO Michael Rossi stated that Y-mAbs continues to invest in DANYELZA ISS, which creates short-term competition for patients but should provide a long-term tailwind and support new indications. He also mentioned the development of a GD2 diagnostic to improve patient selection for future trials. Regarding the CD38 trial, Rossi explained that the difficulty is not related to the SADA platform but to the challenge of finding qualified and healthy enough patients in the very difficult-to-treat refractory non-Hodgkin's lymphoma segment.

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Richard Miller, an executive, stated that receptor occupancy wasn't measured in these patients as it's a matter of chemistry, and extensive data from lymphoma trials already established the required drug concentration. He pointed to the earlier and deeper response kinetics in Cohort 3, along with their sicker baseline status, as evidence for the dose effect. Leiv Lea, an executive, clarified that the cash runway guidance includes the AD Phase I extension and Phase II start, the ongoing Phase III lymphoma trial, and a small Phase I solid tumor trial.

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Richard Miller, an executive, confirmed that the May update will include full data for Cohorts 1, 2, and 3, including biomarker data. He stated that the company is already pleased with the efficacy seen in the first two cohorts, noting a significant difference compared to placebo over a 28-day treatment period. Miller emphasized that as an oral therapy with a strong safety profile and novel mechanism, soquelitinib is well-positioned competitively, and the initial study's goal of demonstrating a signal in an autoimmune disease has been achieved.

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Executive Richard Miller explained that PTCL patients proceeding to transplant are censored for the PFS analysis. He positioned soquelitinib as superior to PI3K inhibitors due to a better safety profile and more durable responses, noting the trial is powered for a 1.5-month PFS improvement. For the renal cell trial, he stated that T-cell health is not an enrollment criterion but will be analyzed retrospectively.

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CEO Fabrice Chouraqui explained that the $10 million in G&A savings is intended to optimize capital allocation towards growth drivers like R&D and commercial operations, not reduce them. Regarding potential tariffs, he stated that while it is too early to comment on specifics, the company is proactively evaluating a range of mitigation scenarios, including adjustments to its supply chain and manufacturing.

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Anurag Relan, Chief Medical Officer, clarified that the estimated 30,000 patients for KL1333 is the addressable population, as it already accounts for the specific mutations being studied. Stephen Toor, Chief Commercial Officer, added that the 188 Joenja patients are global, primarily in early access or compassionate use programs, with an undisclosed number on paid therapy via named patient programs.

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Chief Medical Officer Jared Gollob stated the goal is to demonstrate full, sustained TYK2 degradation (95%+) in blood and skin, which would enable biologic-like activity. CEO Nello Mainolfi added that it was too early to discuss specific Phase II patient selection criteria but that the company would be thoughtful in its approach.

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CEO Nello Mainolfi positioned Kymera as the leader, citing extensive preclinical data showing its degrader can phenocopy dupilumab. He argued that degradation is a superior modality to inhibition for fully blocking the pathway. He noted competitors have not presented data and hinted that Kymera's efforts in STAT6 extend beyond the KT-621 program.

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David Berman, Head of R&D, explained that the common link is the platform's exquisite tissue-targeting capability. The key difference is the effector function: activating T-cells in oncology versus inhibiting them in autoimmune disease. He noted that the preclinical de-risking for the autoimmune programs incorporates many learnings from oncology. CEO Bahija Jallal described the two approaches as the 'yin and yang' of their platform.

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