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CEO Dr. David Chang defended the comparison, stating that the second-line randomized studies serve as a very good reference point, provided one equates MRD conversion with a complete remission (CR). He believes it's a solid benchmark for demonstrating a clinically meaningful benefit on EFS, while acknowledging the ultimate test is the ALPHA-three trial's outcome.

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Dr. David Chang, President and CEO, confirmed the Phase I study for ALLO-329 is designed to answer this directly. It will include a cohort with milder lymphodepletion (cyclophosphamide only) and a parallel cohort with no lymphodepletion, allowing for a direct comparison to find the best path forward.

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Dr. David Chang, President and CEO, explained that the Grade 5 events are very confounded by patients' advanced metastatic disease and prior treatments. Dr. Zachary Roberts, EVP of R&D and CMO, described the IECHS management algorithm as a clear, two-step process analogous to those for CRS and ICANS, which has been easy to implement in the study. He noted that IECHS is now better understood as a spectrum of cytokine release syndrome, making management easier.

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CEO Matt Gline stated that Roivant expects to share top-line, key secondary, and major safety data for the DM trial. He anticipates filing for approval in early 2026, with standard NDA preparation being the primary gating factor. Regarding the Graves' trial, Gline explained the lower dose is included to support discussions with the FDA about a minimally efficacious dose, aiming for a smoother regulatory process.

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CEO & Director Matt Gline explained that a "win" in the DM trial simply means a statistically significant separation from placebo, given the high unmet need. He stated the June event aims to educate investors on DM, trial endpoints, and the commercial opportunity. Regarding the litigation, Gline described the claim narrowing as a normal, procedural step to simplify the case for a jury trial and not indicative of any significant development.

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CEO Matthew Gline responded that while they will use the data to inform development, MG and CIDP are large markets where IMVT-1402 has unique advantages in form factor and dosing, so the data isn't the sole determinant for proceeding. For the sarcoidosis trial, he reiterated it's a small, signal-finding study not powered for a specific statistical endpoint, noting the large effect size in a prior IIT study and a low expected placebo response.

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Priovant CEO Ben Zimmer clarified that there is no specific steroid requirement for entry, allowing for a range up to 40mg/day or none at all. He stated there are no material stratification factors of note. The two sub-studies are primarily for assigning clinical sites, with some larger geographies participating in both while other countries are assigned to one or the other.

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Chief Business Officer Eric Pauwels reported positive payer feedback, noting the clinical profile is well-received with expectations for minimal restrictions and few step-edits. He stated it is too early for contracting discussions and that the payer mix is anticipated to be 65% commercial. CFO Pierre Gravier and CBO Eric Pauwels both confirmed no additional OpEx is expected as the launch leverages existing infrastructure, and there will be no inventory build, with specialty pharmacies carrying just-in-time inventory.

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Chief Scientific Officer Paul Moore clarified the trial design, explaining that dose level one is not a range but a step-up dosing regimen where 38 micrograms is the target dose for that specific level.

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CEO Kenneth Galbraith addressed the trial question, stating that while a KEYNOTE-811 sub-analysis showed some variance, KOLs generally don't see significant efficacy differences across ethnicities, and the HERIZON-GA01 trial is globally diverse. Regarding the J&J partnership, he noted Zymeworks is entitled to future development milestones and a mid-single-digit royalty on sales of the KLK2 product, expressing optimism based on J&J's public comments.

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CEO Kenneth Galbraith clarified that the initial focus is on tolerability, and efficacy evaluation will include durability of response (DOR), which takes time. He explicitly stated not to expect initial clinical data at the R&D Day. For revenue modeling, he referred the question to partner Jazz Pharmaceuticals for guidance, as Zymeworks cannot disclose more than what is public in their agreements.

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President and CEO John Leonard provided a direct and affirmative response, stating, "The answer is yes."

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CEO John Leonard outlined that the preclinical package is complete, and importantly, the commercial form of the product is being used in the Phase III trial, avoiding bridging studies. He also highlighted the RMAT designation, which facilitates accelerated interactions with the FDA. An executive added that interactions with the FDA have been very favorable.

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CEO John Leonard asserted that the key differentiator for success will be achieving normal levels of wild-type protein. He emphasized that Intellia is the only company to have demonstrated this in non-human primates and that success for any approach will depend on delivery and durable protein production over time.

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Executive Peter Salzmann explained that while the TED trial population is more severe, seeing benefits in the milder Graves' population is encouraging for an early-treatment strategy. The TED timeline was updated due to high competition for a narrow patient group. Dr. Peter Taylor opined that due to the availability of cheaper biosimilars, FcRn inhibitors in RA would likely remain a therapy for the difficult-to-treat population, which represents the highest unmet need.

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Executive Peter Salzmann stated that seeing proptosis changes in the Graves' trial (which had milder TED) is encouraging for the goal of treating TED earlier. He attributed the updated TED trial timeline to increased competition for eligible patients. Dr. Peter Taylor opined that for RA, FcRn inhibitors would likely be used in the difficult-to-treat population due to the prevalence of less expensive biosimilars and generics in earlier lines of therapy.

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President and CEO Dr. Helen Sabzevari explained that the confirmatory trial has a similar design and response bar as the pivotal Phase I and II studies, utilizing a single-arm, no-placebo design. She clarified that under the accelerated approval pathway, the trial only needs to be initiated at the time of BLA submission, not completed for approval. She also noted that the trial has already been initiated with strong patient interest.

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Dr. Helen Sabzevari, President and CEO, explained that the confirmatory trial's design and response criteria are identical to the pivotal Phase I and II trials, featuring a single-arm, non-placebo-controlled design. She clarified that under the accelerated approval pathway, the trial only needs to be initiated at the time of the BLA submission and completion is not a prerequisite for approval. She also noted enrollment has already begun with strong patient interest.

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The company expects a 'relatively swift' launch uptake for PRGN-2012 due to a concentrated prescriber base. While commercialization will increase expenses, the company is managing costs and is confident in its ability to strengthen its balance sheet. The UltraCAR-T platform's advantages have created significant partnership excitement, and updates will be provided as they progress.

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The Phase I/II/III designation means it's a single study that can support a BLA, keeping them on track. Investigators are reportedly pleased with the correction of anemia, observing that patients are less fatigued and have more energy. They appreciate the potential for sustained normal hemoglobin levels to impact end-organ function, which is a key area of potential differentiation.

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The company reiterated that the psoriasis study's primary goal is to gather biomarker data on Treg counts to inform dosing, not to achieve a specific PASI score. They are still guiding for data in 2024.

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