Brian Cheng

Brian Cheng inquired about Roivant's latest thinking on the size and dose for the brepocitinib Phase III study in cutaneous sarcoidosis, the expected stability of efficacy from Phase II to Phase III, and asked for more color on the return of certain batoclimab rights from HanAll.

Answer

Matt Gline, CEO of Roivant, and Benjamin Zimmer, CEO of Priovant Therapeutics, discussed the significant cushion in the Phase II data and the rigor of the multi-center study. Zimmer indicated a Phase III size similar to the DM trial is likely, pending FDA discussions, and reinforced confidence in the 45mg dose. Gline clarified that the return of HanAll rights has no read-through to the upcoming TED data, only to future development decisions for batoclimab.

Brian Cheng inquired about Roivant's latest thinking on the phase 3 size and dose for brepocitinib in cutaneous sarcoidosis, the expected stability of efficacy from phase 2 to phase 3, and the read-through of the return of certain batoclimab rights from HanAll to the upcoming TED data readout.

Answer

Benjamin Zimmer, CEO of Priovant Therapeutics, noted the significant cushion from phase 2 data and suggested a phase 3 size similar to the dermatomyositis trial, reinforcing the 45mg dose. Matt Gline, CEO of Roivant, clarified that the batoclimab rights return has no read-through to TED data, as it pertains to future development decisions with HanAll.

Brian Cheng inquired about the impact of Argenx entering the Graves' disease market on Roivant's 1402 strategy and what investors should expect from the upcoming Investor Day.

Answer

CEO Matthew Gline viewed Argenx's entry into Graves' disease as validation, emphasizing Roivant's competitive profile with higher-dose batoclimab and deeper IgG reduction. For Investor Day, he highlighted it as a moment of transformation to fully tell the business story, discuss commercial opportunities, and potentially share new updates.

Brian Cheng asked about Argenx's entry into the Graves' disease market and its impact on Roivant's 1402 strategy, and also what investors should expect from the upcoming investor day.

Answer

CEO Matt Gline acknowledged the competitive landscape in Graves' disease, noting Roivant's strong competitive profile with higher-dose Batoclimab and significant IgG reduction. He emphasized the large patient population and the validating nature of competition. Regarding the investor day, he stated it would focus on the business's transformation, commercial perspective, patient needs, and blockbuster opportunities, with potential for new updates.

Brian Cheng inquired about the upcoming top-line data release for brepocitinib in dermatomyositis (DM), the expected timeline for an FDA filing, and the rationale for testing a lower 300mg dose of IMVT-1402 in the second Graves' disease trial.

Answer

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.

Brian Cheng of J.P. Morgan inquired about the definition of a successful outcome for the upcoming dermatomyositis (DM) trial and the focus of the June investor event. He also asked for clarification on the recent docket update regarding the narrowing of claims in the LNP litigation against Moderna.

Answer

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.

Brian Cheng asked about Roivant's commitment to advancing IMVT-1402 into MG and CIDP irrespective of upcoming data, and sought details on the brepocitinib sarcoidosis trial's design and rationale.

Answer

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.

Brian Cheng from JPMorgan Chase & Co. asked for specifics on the brepocitinib CLARITY Phase III trial design, including steroid dose requirements for entry, key patient stratification strategies, and the distinction between the CLARITY-1 and CLARITY-2 sub-studies.

Answer

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.

Brian Cheng asked about the latest thinking on the size and dose for the Brepo Phase 3 study in cutaneous sarcoidosis, the expected stability of efficacy from Phase 2 to Phase 3, and a follow-up on the return of certain batoclimab rights to HanAll and its read-through to TED data.

Answer

CEO Matt Gline noted a significant cushion in the Phase 2 data's quality. CEO Ben Zimmer added that while some erosion is possible, the large effect size provides confidence, and the Phase 3 size would likely be similar per arm to the DM trial, pending FDA discussions. Matt Gline clarified that the batoclimab rights return has no read-through to TED data, being a decision on future development with HanAll.

Brian Cheng, Executive Director and Senior Biotech Analyst at JPMorgan Chase & Co., asked about the anticipated size and dose for brepocitinib's phase 3 study in cutaneous sarcoidosis, the expected stability of efficacy from phase 2 to phase 3, and any read-through from the return of certain batoclimab rights to the upcoming TED data readout.

Answer

Matt Gline, CEO of Roivant Sciences, noted the significant cushion in the phase 2 data's quality. Ben Zimmer, CEO of Priovant, stated that while some erosion is possible, the large effect size provides confidence for phase 3, which would likely have a similar per-arm size to the DM trial, with 45mg reinforced as a compelling dose. Matt Gline clarified that the return of batoclimab rights has no read-through to the TED data, being a decision related to future development.

Miriam, on behalf of Brian Cheng from JPMorgan Chase & Co., asked how the extrathyroidal benefits in Graves' disease read through to the TED trial and about the updated timeline. She also inquired about the potential real-world sequencing of FcRn inhibitors in RA.

Answer

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.

Speaking on behalf of Brian Cheng, an analyst asked how the extrathyroidal benefits from the Graves' trial read through to the ongoing Thyroid Eye Disease (TED) trial and about the updated timeline. A follow-up question for Dr. Taylor concerned the future sequencing of FcRn inhibitors in RA treatment.

Answer

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.

Brian Cheng of J.P. Morgan questioned if the 30% MRD conversion delta, a benchmark derived from later-line trials, is a fair bar for success in the earlier, first-line consolidation setting, suggesting the bar should be higher.

Answer

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.

Brian Cheng from JPMorgan Chase & Co. inquired about the company's strategy for potentially using milder lymphodepletion or eliminating it entirely for ALLO-329, and the timeline to determine the optimal approach.

Answer

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.

Sean on for Brian Cheng asked for more details on the Grade 5 adverse events reported for ALLO-316, including any confounding factors, and requested an explanation of how the management algorithm for IECHS is implemented and its ease of use for physicians.

Answer

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.

Brian Chung of JPMorgan Chase & Co. inquired about the importance and timing of securing a partner for the CHS-114 (anti-CCR8) program and asked for an update on the company's confidence in achieving its $150M-$200M revenue goal for Loktorzi.

Answer

Chief Medical Officer Rosh Dias outlined the data readout timeline for CHS-114, expecting efficacy and safety data in H1 2026. CEO Dennis Lanfear and Chief Scientific & Development Officer Theresa Lavallee emphasized their focus on finding the right partner to maintain development speed and leverage the asset's broad combinability. EVP of Commercial Sameer Goregaoker expressed high confidence in the Loktorzi revenue target, citing the strong uptake in academic centers following NCCN guideline updates as a key positive indicator.

Brian Cheng of J.P. Morgan asked about early payer feedback on Sefiance and what it suggests for future contracting and net pricing. He also inquired about any significant inventory build for the launch and expected changes to the SG&A expense line.

Answer

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.

Brian Cheng of J.P. Morgan sought clarification on the Phase 1 dose escalation design for ZW171, specifically asking if the initial dose level represented a range from 4.2 micrograms to 38 micrograms.

Answer

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.

Brian Cheng of JPMorgan asked about the potential impact of the ex-U.S. patient population on the zanidatamab Phase III HERIZON-GA trial outcome, referencing subset analysis from KEYNOTE-811. He also requested an update on the J&J KLK2 bispecific program and the financial terms of the partnership.

Answer

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.

Brian Cheng inquired about the efficacy criteria for advancing ZW171 and ZW191 to expansion stages, whether to expect data at the December R&D Day, and how to model near-term partnership revenue.

Answer

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.

Brian Cheng of J.P. Morgan sought confirmation on whether the expanded MAGNITUDE study is now statistically powered to show a significant difference in the subset of patients on a stabilizer background.

Answer

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

Brian Cheng inquired about the key gating factors for the NTLA-2002 BLA filing in HAE, beyond the clinical data package, that need to be aligned ahead of the planned 2026 submission.

Answer

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.

A representative for Brian Cheng asked how Intellia's NTLA-3001 for AATD is differentiated from competing RNA editing therapies, especially following recent data from peers.

Answer

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.

On behalf of Brian Cheng, Sean asked about the required response bar for the PRGN-2012 confirmatory trial and whether its enrollment must be completed prior to potential FDA approval.

Answer

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.

On behalf of Brian Cheng, an analyst asked for clarification on the required response bar for the PRGN-2012 confirmatory trial and whether its enrollment must be completed prior to receiving FDA approval.

Answer

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.

Asked about the expected launch trajectory for PRGN-2012, projected sales-related expenses, the company's cash runway, and the latest status on partnerships for the UltraCAR-T platform.

Answer

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.

Asked about the timeline implications of the Phase I/II/III designation for the RUBY trial and for feedback from investigators on whether they are seeing early signs of clinical differentiation for Reni-cel.

Answer

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.

Asked for more specific timing on the XmAb564 psoriasis data and what efficacy benchmark (PASI score) would provide conviction for further development.

Answer

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.