Brian Cheng • JPMorgan Chase & Co.

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David Chang, CEO, defended the reference point, stating that the second-line randomized studies for Yescarta and Briansi are a good benchmark, provided one accepts the premise that MRD conversion is analogous to a complete remission (CR). He believes this comparison provides a solid basis for what could yield a clinically meaningful EFS benefit, though the ALPHA-three study will be the ultimate test.

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President and CEO Dr. David Chang clarified that the Phase I RESOLUTION trial is designed to answer this directly. The study will include parallel cohorts: one using a milder lymphodepletion regimen of cyclophosphamide alone (without fludarabine), and another testing ALLO-329 with no lymphodepletion, relying on the Dagger technology.

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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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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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