Peter Lawson

Peter Lawson asked about the sustainability of Naktinvo's growth trajectory, which was impressive this quarter, and the profitability of the Naktinvo franchise.

Answer

CEO Bill Meury noted Naktinvo's strong start, annualizing at almost $200 million, with 90% of US BMT centers using it and positive feedback. He expects solid growth next year, comparing its launch curve to Resurrect. EVP and General Manager, North America, Mohamed Issa added that repeat orders and increasing preference in the third-line setting (currently mostly fourth-line) support sustainability, with the goal of 1,000 active patients by year-end on track. Bill Meury highlighted Naktinvo as a specialty product with a targeted audience, leading to a very healthy margin profile, which Mohamed Issa confirmed as one of the higher contribution margins in the portfolio.

Peter Lawson of Barclays Capital inquired about the key drivers for XPOVIO revenue in the quarter, specifically the contribution from volume, pricing, and inventory. He also asked about the company's confidence that the encouraging blinded safety data for myelofibrosis will hold up once unblinded.

Answer

CEO Richard Paulson noted that inventory was relatively consistent and that revenue drivers were a balance of consistent demand and an improved gross-to-net percentage following a one-time returns issue in the prior quarter. Chief Medical Officer Reshma Rangwala expressed confidence in the blinded safety data trends, noting that multiple snapshots over time have shown a consistent and favorable evolution compared to stable historical data for ruxolitinib monotherapy, which strengthens the extrapolation.

Peter Lawson questioned the $5 million in product returns, asking about the normal run rate and future risk, and also inquired about the company's plans to extend its cash runway.

Answer

Lori Macomber, EVP and Chief Financial and Administrative Officer, explained the returns were an atypical event related to older, high-dose units from the 2021-2022 launch and does not expect a recurrence. She stated the gross-to-net provision should return to historic levels. Regarding the cash runway, Macomber confirmed the company is exploring various alternatives to extend it but could not provide specific details at this time.

Alex, on behalf of Peter Lawson from Barclays, asked about the criteria for success in the endometrial cancer trial that would prompt Karyopharm to seek regulatory approval. He also requested an update on the SENTRY-2 study in JAK-naive patients, including timing and expected data disclosure.

Answer

Chief Medical Officer Reshma Rangwala stated that a meaningful benefit, such as a median PFS delta of over six months combined with an improved safety profile due to lower starting doses and antiemetics, would be considered a very strong outcome for the endometrial cancer trial. President and CEO Richard Paulson addressed the SENTRY-2 trial, confirming that initial data would be shared in the first half of the year but did not comment on specific abstract submission status.

Peter Lawson questioned the underlying trends behind XPOVIO's quarterly revenue growth, including the mix between settings, and asked about the regulatory strategy and enrollment progress for the MMR-proficient subgroup in the endometrial cancer trial.

Answer

EVP, Chief Commercial Officer Sohanya Cheng attributed the growth to double-digit demand increases in both community (60% of business) and academic settings. EVP, Chief Medical Officer Reshma Rangwala added that no specific FDA alignment is needed for the MMR-proficient subgroup as it falls under the primary p53 wild-type population. She confirmed enrollment is on track for an early 2026 data readout, driven by enthusiasm for the strong PFS data from the SIENDO trial.

Requested details on the upcoming Q1 2026 Phase 1 update for the EpCAM ADC (CX-2051), including the number of patients, scope of data (durability, biomarkers), and whether the subsequent Phase 2 trial will be randomized.

Answer

The Q1 2026 update will include data from approximately 70 patients, a significant increase from the initial disclosure. The data will focus on three dose levels (7.2, 8.6, and 10 mg/kg) and should have reasonable follow-up for durability. The update will also include the go-forward plan for Phase 2, which is likely to be a randomized study against the standard of care in the fourth-line setting.

Peter Lawson of Barclays Capital asked for details on the upcoming Phase 1 update for the EpCAM ADC (CX-2051) in Q1 2026, including the size of the dataset, durability, and whether the subsequent Phase 2 trial would be randomized.

Answer

Sean A. McCarthy, Chairman & CEO, confirmed the Q1 2026 update will include data from approximately 70 patients, a significant increase from the initial 18. He expects to have reasonable follow-up and will integrate the data into the Phase 2 go-forward plan. He also stated it is 'most likely' that the next study would be randomized against standard of care in the fourth-line setting.

Peter Lawson asked about the potential for the Phase 2 study to be registrational, any discussions with regulators about accelerated development, the use of prophylactic strategies to reduce GI toxicities, and the design of a potential comparator arm.

Answer

CEO Sean McCarthy explained it's too early for specifics on a registrational path but the strong data should open avenues for expedited development, which will be discussed with the FDA after more data is collected. He noted the dose expansion is mindful of Project Optimus. CMO Yu-Waye Chu added that prophylactic loperamide has been recently implemented to manage diarrhea, a strategy that has proven effective for other ADCs, and expects this to improve the GI toxicity profile going forward.

Questioned the rationale for prioritizing colorectal cancer (CRC) for the EpCAM ADC, the bar for success in late-line CRC, and what specific outcomes would be considered a win in the initial data release.

Answer

The focus on CRC is driven by high EpCAM expression, significant unmet need, and the suitability of the topo-1 payload. The bar for success in this late-line setting is low; any RECIST responses would be a major win, but tumor stabilization and pharmacodynamic activity would also be positive signals.

Peter Lawson from Barclays Capital asked about the company's confidence in the Proleukin revenue forecast, the specific drivers for its expected acceleration in the second half, and whether the number of Proleukin injections per patient has changed.

Answer

Chief Commercial Officer Dan Kirby explained that confidence is high because two of the three major U.S. wholesalers resumed regular ordering in Q2, which will better align Proleukin sales with Amtagvi demand. He confirmed the average number of Proleukin doses per patient remains consistent and that revenue from manufacturing and clinical trial channels is also expected to continue.

Peter Lawson of Barclays asked if manufacturing success rates have returned to normal, whether the Q1 issue was related to any Q4 problems, and for a breakdown of the revenue guidance revision between demand versus manufacturing uncertainty.

Answer

Interim CEO Frederick Vogt and COO Igor Bilinsky confirmed there was no manufacturing success issue in Q4 and that rates have already rebounded in Q2. Vogt stated the guidance revision is driven by ATC launch dynamics and learning curves, not fundamental uncertainty in demand or manufacturing capability.

Peter Lawson inquired if the Q4 spike in Proleukin (IL-2) revenue is a leading indicator for future Amtagvi demand or simply distributor stocking, and asked about its potential contribution to 2025 revenue.

Answer

Interim CEO and President Frederick Vogt confirmed that Proleukin revenue continues to be a leading indicator for Amtagvi sales. He attributed the Q4 performance to full uptake by all major U.S. distributors and projected that Proleukin could contribute $80 million to $100 million or more to the full-year 2025 revenue guidance.

Peter Lawson from Barclays inquired about the stocking levels of Proleukin (IL-2), asking how the dynamic is expected to change over time and what the numbers might look like in the future.

Answer

Interim CEO Frederick Vogt explained that Iovance is stocking three major distributors sequentially, with one expected in Q4. He noted that Proleukin sales could increase in Q4, but after that, starting in 2025, growth is expected to normalize and follow a more traditional quarter-over-quarter pattern.

Peter Lawson inquired about the current status of the FDA dialogue for Zifdomenib, asking if the frequency or emphasis has changed, and questioned the importance of the AML maintenance setting and Kura's ability to capture that market.

Answer

Chief Medical Officer Dr. Mollie Leoni reiterated that FDA interactions are proceeding as expected for a priority review with no change in frequency or quality. On the maintenance setting, Dr. Leoni and CCO Brian Powl explained that while not an initial indication, it is built into the COMET-seventeen frontline trial design and represents a significant opportunity for extended treatment duration.

Peter Lawson from Barclays asked about the GIST program, inquiring which patient segments might be most responsive to the ziftomenib-imatinib combination and what the key decision-making endpoints like ORR or PFS would be.

Answer

Executive Mollie Leoni described the approach as 'mutationally agnostic' and potentially transformative, as it should work in both imatinib-naive and refractory patients by targeting KIT through two different mechanisms. She expects to see deeper and longer-lasting responses (PFS) and noted that salvaging a failing response would be a clear sign of synergy.

Peter Lawson of Barclays inquired about the status of Kura's diabetes program, including the timeline for nominating a candidate and its strategic priority. He also asked about the ideal strategy to capture the program's value without diluting the company's oncology focus.

Answer

CEO Troy Wilson confirmed a development candidate for diabetes is targeted for mid-2025, with interest in both Type 1 and Type 2 diabetes. He described the program as a high-value 'call option' that would require a partnership for late-stage development. The ideal strategy would involve a structure that separates the IP and allows for monetization to benefit Kura shareholders in the nearer term.

Peter Lawson of Barclays asked about efficacy expectations for ziftomenib in patients previously treated with venetoclax and whether the duration of response might differ between NPM1 and KMT2A patients in the 7+3 cohort.

Answer

EVP of Clinical Development, Dr. Mollie Leoni, expressed encouragement about potential responses post-venetoclax failure, with more data coming at ASH. For duration of response, she noted it's too early to tell as most patients remain on therapy, but highlighted that while KMT2A is a more aggressive disease, ziftomenib may act as a 'great equalizer'.

Peter Lawson of Barclays Capital asked for the company's perspective on potential impacts from shifting U.S. trade policy, including tariffs and IP, on its manufacturing costs and supply chain.

Answer

Travis Coy, CFO, acknowledged the uncertainty and stated the company is monitoring the situation. Since Chemtrec is manufactured in Europe, tariffs could have a non-immediate impact on COGS. To ensure patient supply continuity, the company has built up approximately 18 months of inventory in the United States.

Peter Lawson of Barclays asked for clarification on the upcoming HIV data, specifically regarding the bar for success, whether it's viral reservoir reduction or delay in rebound, and the number of patients and doses to be presented.

Answer

David Berman, Head of R&D, reiterated that data from three dose cohorts of 5-6 patients each will be presented, with dose escalation ongoing. He explained that in a Phase I trial for a novel therapy where no treatment has reliably worked, success is defined by seeing clear signals of activity, such as reservoir reduction or altered rebound kinetics. A better understanding of the rate of patient control will come from the expansion cohort later in the year.

Asked about the drivers of U.S. revenue growth in the quarter, whether there were any one-time items, and if there was any guidance for the first quarter.

Answer

Ralph Torbay attributed the 13% U.S. growth to increased penetration in the community setting, which now accounts for the majority of prescriptions. He stated that growth is expected to continue incrementally in the U.S. No one-timers were mentioned, and no specific Q1 guidance was provided.

Peter Lawson from Barclays asked for details on the commercial build-out, including the potential size of the US field team and key milestones over the next twelve months. He also inquired about the PRMT5 inhibitor combination, asking which tumor types were being prioritized.

Answer

Chief Global Commercialization Officer Anthony Mancini confirmed the build-out of the US field team has begun, with MSL and thought leader liaison teams already in place, but did not provide specifics on size or future milestones. President of R&D Steve Kelsey clarified that the PRMT5 combo trial, sponsored by Tango, primarily targets pancreatic cancer due to the high overlap between RAS mutations and MTAP deletion in that tumor type.

Peter Lawson asked what to look for in the upcoming combination datasets for RMC-6236 with pembrolizumab and RMC-6236 with RMC-6291, focusing on the balance between side effect profiles and efficacy signals.

Answer

Dr. Mark Goldsmith, Chairman and CEO, explained that the pembrolizumab combination study is primarily focused on safety, specifically monitoring for the hepatotoxicity seen with first-generation RAS(OFF) inhibitors. For the RMC-6236 plus RMC-6291 RAS(ON) doublet, the focus is less on tolerability and more on observing qualitative evidence of enhanced anti-tumor activity that distinguishes the combination from monotherapy, mirroring preclinical findings.

Peter Lawson asked about the sustainability of the 17% quarter-over-quarter demand growth for Rytello and requested additional data points regarding the company's Key Opinion Leader (KOL) engagement strategy.

Answer

Jim Ziegler, EVP & CCO, addressed growth sustainability by highlighting the focus on new patient starts and the positive trend of physicians moving to earlier lines of therapy. He and Dr. Joseph Eid, EVP of R&D, detailed the KOL strategy, which involves increased engagement through speaker programs, peer-to-peer initiatives, and tailored advisory meetings to build advocacy and gather insights.

Peter Lawson from Barclays asked for clarification on the Q1 inventory issue, whether it was now resolved, and for details on the sales team's coverage of the 1,300 high-priority healthcare providers.

Answer

Jim Ziegler, Chief Commercial Officer, attributed the Q4 inventory build to distributors' historical forecasting, seasonality, and general buy-and-bill pricing concerns. He confirmed the inventory was drawn down in Q1 and the situation is now stable. Regarding HCP coverage, Ziegler stated the 20% increase in the sales force will enable more frequent engagement with the 1,300 target physicians but did not provide a specific current coverage percentage.

Peter Lawson of Barclays inquired about the recent flat revenue trend for Rytelo, asking if it extended into January and February, and sought clarity on the outlook for Q1 2025 revenues. He also requested guidance on full-year 2025 revenues and costs in the context of the company's goal to reach profitability.

Answer

Jim Ziegler, Chief Commercial Officer, confirmed that 4- and 8-week rolling revenue averages showed flatness that continued into early 2025, making it premature to forecast Q1. Michelle Robertson, Chief Financial Officer, reiterated that Geron is not yet providing revenue guidance but maintained the 2025 operating expense forecast of $270 million to $285 million, stating the company has levers to pull to manage costs and that internal profitability forecasts remain unchanged.

Peter Lawson asked for the expected timing of the first-in-human data for the KRAS G12D degrader (ARV-806) and for details on trial enrollment. He also inquired about what metrics to focus on in the upcoming second-half data release for the BCL6 degrader (ARV-393).

Answer

CMO Noah Berkowitz indicated that guidance on the timing for ARV-806 data would be provided soon, likely for release sometime next year, and noted that enrollment is progressing well. For the ARV-393 update in the second half of the year, he suggested focusing on standard dose-escalation metrics: safety, pharmacokinetics (PK), and early signs of efficacy, with a reasonable patient number estimate being in the 10-20 range.

Peter Lawson inquired about the planned size of the sales force for vepdegestrant and whether the Pfizer partnership would preclude Arvinas from finding a different partner to run a first-line study.

Answer

CEO John Houston described a plan for an "appropriately sized" sales force for a targeted launch to roughly 6,000 key oncologists under the 50-50 U.S. co-commercialization agreement. He stated unequivocally that Arvinas is committed to its Pfizer partnership and would not seek another partner, emphasizing that future decisions will be made jointly as more data becomes available.

Peter Lawson sought reassurance on the upcoming FDA approval for Revuforge in NPM1 AML, asking about any remaining open items or feedback. He also asked for an estimate on the percentage of patients who could eventually receive post-transplant maintenance therapy.

Answer

CMO Dr. Nick Botwood reported that the sNDA submission for NPM1 is progressing very well, with positive and consistent dialogue with the FDA and no indication of issues. CEO Michael Metzger reiterated that physicians aim to put the vast majority of eligible patients on maintenance therapy, a likelihood that increases with earlier treatment, but did not provide a specific percentage.

Peter Lawson of Barclays inquired about emerging trends in GVHD patient subgroups being treated with Niktimvo and also asked for an update on the go-forward signal for the MSS-CRC program.

Answer

Chief Scientific Officer Dr. Peter Ordentlich addressed the GVHD question, stating it is too early to comment on specific subgroup trends as real-world evidence is still being collected. CEO Michael Metzger commented on MSS-CRC, noting the trial is ongoing and the company is looking for prolonged stable disease, with an update expected later in the year.

Peter Lawson of Barclays questioned the real-world use of Revuforj, specifically regarding off-label use in NPM1 or in combination, the number of patients remaining in the Expanded Access Program (EAP), and the commercial momentum in early 2025.

Answer

CCO Steven Closter confirmed anecdotal off-label use in NPM1 and combinations but stated it's too early to quantify. He clarified that all eligible EAP patients have been transitioned (a single-digit number) and the program is now only lightly used. He and CEO Michael Metzger affirmed that launch momentum remains strong, driven by post-ASH reviews and growing payer coverage.

Peter Lawson of Barclays questioned whether the recent royalty sale for Niktimvo would accelerate any development programs and asked about the timing and process for the NPM1 data release and subsequent guideline inclusion.

Answer

CEO Michael Metzger confirmed the $350 million from the royalty agreement provides a pro forma cash balance of approximately $750 million, enabling the company to aggressively advance its entire portfolio. He also detailed the NPM1 strategy: release pivotal data, publish it, and then submit for NCCN guidelines, which could precede formal regulatory approval for that indication.

Peter Lawson from Barclays asked for guidance on how to model clinical trial revenues for the second half of 2025.

Answer

CFO Christopher Senner reiterated the company's long-standing position that clinical trial sales are 'choppy' and unpredictable. He stated that the company lacks sufficient line of sight to provide a reliable forecast for this revenue component.

Peter Lawson asked about the amount of clinical trial sales included in the quarter's revenue and inquired about the company's pricing power in RCC.

Answer

CFO Christopher Senner specified that clinical trial sales contributed approximately $12 million to revenue in the first quarter. The question regarding pricing power was not addressed in the provided transcript.

Peter Lawson requested an update on the status of the CONTACT-02 trial in prostate cancer, noting it was not mentioned in the prepared remarks.

Answer

President and CEO Michael Morrissey reiterated a point made earlier in the call, stating that the company's 'singular focus' is on the regulatory review and approval of cabozantinib for the NET indication. He confirmed that once that process is complete, the company will turn its attention back to the CONTACT-02 opportunity.

Peter Lawson asked for clarification on the long-term revenue outlook, questioning if the $5 billion zanzalintinib forecast for 2033 implies that CABOMETYX revenue will decline to zero after its loss of exclusivity around 2030.

Answer

President and CEO Michael Morrissey confirmed the CABOMETYX loss of exclusivity (LOE) is expected in the early 2030s. He reiterated that the provided slide illustrates zanzalintinib's potential for dramatic growth as pivotal trials read out, driving significant upside for the company.

Peter Lawson asked about any remaining gating factors before the PDUFA date, particularly around CMC, and inquired about learnings from peer launches, plans for revenue guidance, and market penetration strategy.

Answer

CEO Sushil Patel and CFO Emily Hill confirmed that manufacturing inspections are complete with no bottlenecks anticipated for the PDUFA date. Ms. Hill stated that the company will initially provide launch metrics like patient numbers before issuing formal revenue guidance. CCO Christopher Sarchi positioned RP1 as a first-choice option for patients progressing on PD-1 therapy, emphasizing its strong efficacy, safety, and convenience profile as key differentiators to support rapid adoption and market penetration.

Peter Lawson inquired about Arcus's pipeline reprioritization, specifically the status of the adenosine inhibitor etrumadenant, and asked for details on the upcoming ASCO presentation for casdatifan, questioning what new data would be presented beyond the abstract.

Answer

CEO Terry Rosen confirmed that plans for etrumadenant are not moving forward at this time. He stated the company's top priority is casdatifan, with the domvanalimab program's spending naturally winding down and the PRISM-1 trial expected to be fully enrolled in 2025. Regarding ASCO, Rosen explained the abstract was a placeholder and the oral presentation will feature a more recent data cut, including safety data for approximately 40 patients and efficacy data for about 25 patients.

Peter Lawson of Barclays asked about the factors driving the timing of Gilead's opt-in decision for casdatifan and what Arcus's contingency plan is if Gilead declines the option.

Answer

CEO Terry Rosen explained the timing is based on the data package delivery and Gilead's contractual review period, which spans the year-end. He stated that if Gilead doesn't opt-in, Arcus is comfortable proceeding alone but has also received inbound interest from other potential partners. CFO Bob Goeltz added details on the $150M opt-in fee and 50/50 cost share.

Peter Lawson of Barclays asked for the definition of success for the upcoming second-half data release on the HIF-2 alpha inhibitor, casdatifan. He also sought clarification on the trigger points for Gilead's potential opt-in for the program.

Answer

CEO Terry Rosen explained that success for casdatifan would be defined by differentiation from belzutifan across several metrics, including response rate, rate of primary progression, and depth of response. He emphasized the program's goal is to combine casdatifan with a superior TKI. Regarding the Gilead opt-in, Rosen stated that a decision is expected toward the end of 2024 or early 2025.

Peter Lawson from Barclays asked how many Authorized Treatment Centers (ATCs) have infused more than one patient, the company's confidence in reaching its 30-center target by year-end, and whether any manufacturing bottlenecks exist.

Answer

Executive Cintia Piccina confirmed that some ATCs have treated multiple patients and that the site onboarding pace is ahead of schedule. Executive John Lunger stated there are no capacity constraints, highlighting a 100% manufacturing success rate and a vein-to-vein time under the 30-day target, which he noted as key differentiators from other CAR-T launches.

Peter Lawson asked when the next patient is expected to be apheresed and for the company's current cash runway projection.

Answer

CEO Adrian Rawcliffe responded that the next patient apheresis would be 'soon' and that the currently identified double-positive patients are expected to flow through the process into 2025. He reiterated that the company no longer provides forward cash runway guidance to avoid implying specific sales projections. However, he highlighted the Q3 liquidity of $186 million and the new restructuring plan designed to achieve operating cash flow breakeven in 2027.

Inquired about OGSIVEO demand dynamics beyond September, specifically regarding month-over-month growth in Q3 and the outlook for Q4.

Answer

The company is poised for acceleration, with August and September being successively their largest months ever. Growth is supported by a larger-than-anticipated addressable market (10,000+ patients identified via ICD-10), high physician satisfaction and intent to prescribe, benefits from the new blister pack, and upcoming long-term data from CTOS supporting extended treatment. They feel very positive about Q4 and beyond.

Peter Lawson of Barclays asked about the development timeline for the second-generation B7-H3 asset, MGC026, and what specific outcomes from the first-generation asset, vobra duo, would be necessary for it to move forward.

Answer

Dr. Scott Koenig, President and CEO, stated that data from the MGC026 Phase I study is expected in 2025 and that the molecule could be competitive despite being behind others. For vobra duo, he reiterated that a go-forward decision depends on the final rPFS and safety data from TAMARACK, and whether further dose adjustments are needed to pursue a prostate cancer indication.

Asked for a characterization of the spider plots, the reason for the higher confirmed PSA50 reduction in the lower dose arm, and which endpoint (PSA, ORR, or DCR) best correlates with PFS for this agent.

Answer

The executive described the spider plots as "exceptionally encouraging," with sustained PSA reductions. He suggested the difference in confirmed PSA50 between doses is likely "spurious" and not to be over-interpreted. He believes that rPFS and disease control rate will be the best correlates for clinical benefit.

Peter Lawson of Barclays PLC asked about the characteristics of the spider plots, the reason for higher confirmed PSA50 response in the lower dose arm, and which efficacy metric best correlates with progression-free survival for vobra duo.

Answer

Dr. Scott Koenig, President and CEO, described the spider plots as 'exceptionally encouraging' with sustained PSA reductions. He suggested the difference in confirmed PSA50 rates between doses was likely 'spurious' at this interim stage. He believes radiographic progression-free survival (rPFS) and disease control rate will be the best correlates for the primary endpoint.

Asked if the ASCO abstract will detail safety data like discontinuation rates, if the TAMARAC study includes patients previously treated with radiopharmaceuticals, and questioned the puts and takes for maintaining cash guidance despite trial expansions.

Answer

Scott Koenig confirmed the abstract will have discontinuation rates but was unsure about the level of detail on specific AEs. He noted that very few patients were previously treated with radiopharmaceuticals. James Karrels added that the cash runway guidance into 2026 already incorporates the costs of the new Vobaduo cohorts, supported by savings and potential future milestones.

Asked about the potential for further growth in the number of physicians prescribing AYVAKIT to many patients, as shown on a presentation slide.

Answer

The company sees significant headroom for growth in both the breadth and depth of prescribing, not just among top specialists but also by expanding into new specialties, and does not see the current prescriber metrics as a plateau.

The analyst asked about the potential combination agents and indications being considered for the CDK7 program, as well as for guidance on cash burn expectations for the second quarter and the full year 2024.

Answer

The executive outlined potential paths for CDK7, including in ER+/HER2- breast cancer (likely with a SERD like fulvestrant) and potentially with immunotherapies in areas like lung cancer, which is possible due to their drug's favorable safety profile. Regarding financials, the company expects the trend of reduced cash burn to continue through 2024, with the recently announced savings extending their cash runway well into 2027, covering key clinical milestones.

Asked about large pharma's evolving strategy towards AI, whether Exscientia needs to acquire large patient data sets, and for clarification on the upcoming MALT1 program update.

Answer

Large pharma's interest in AI is strong and varied, with a focus on Exscientia's differentiated technologies. The company does not need petabytes of data as it is a 'learning company' that generates its own specific, proprietary data for design problems. The MALT1 update in the first half of 2024 will include both a preclinical data update and a developmental plan.

For Peter Lawson of Barclays, an analyst requested a recap of the ASGCT data, asking for notable differences between FT819 (CAR-T) and FT522 (CAR NK) regarding tissue distribution and B-cell depletion, and the implications for selecting autoimmune indications.

Answer

Dr. Bob Valamehr, Chief Research and Development Officer, highlighted that FT522's ADR and IL-15 features allow for excellent biodistribution and multi-antigen targeting, while FT819 is a very potent CAR-T. CEO Scott Wolchko added that FT819's high CXCR4 expression aids tissue infiltration. He confirmed these differences are being actively considered in their autoimmune expansion strategy, though specifics are not yet public.

Asked about the specific autoimmune indications being considered for FT522, whether the trial would start without conditioning, and for financial guidance on R&D and SG&A for 2024.

Answer

For FT522, the company is considering a broad range of B-cell mediated autoimmune diseases, potentially including SLE and others. They plan to explore various regimens, including no-conditioning options, in the autoimmune setting. While not providing formal guidance, they suggested the cash operating expense run rate from the last two quarters (~$35-40 million per quarter) is a reasonable baseline for the first half of 2024.