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President & CEO Brian Lian explained that placebo retention will be encouraged through diet and exercise counseling, regular clinician visits, and, importantly, eligibility for an open-label extension with active treatment after the trial. For the amylin program, he stated that based on internal models, their compounds are competitive on appetite and body weight reduction, and they look forward to human data.

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Brian Lian, President and CEO, acknowledged that a formal food effect study has not yet been conducted but will be, and an effect is expected. Regarding supply chain, he reported that suppliers have not raised any concerns about the availability of starting materials, suggesting supply should be adequate as they scale up.

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CEO Sean McClain, CFO & CBO Zachariah Jonasson, and SVP of Drug Creation Christian Stegmann responded. McClain detailed the in-house bispecific strategy for ABS-101. Jonasson stated he could not comment on specific partnership milestones due to confidentiality. Stegmann acknowledged the competitive HER2 space for ABS-501 and noted ongoing preclinical studies will define its niche.

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CFO and CBO Zachariah Jonasson confirmed that discussions are advancing with a mix of different company types and sizes but could not offer more specifics. Founder and CEO Sean McClain acknowledged a slight delay for ABS-301, attributing it to scheduling at their CRO and not to the study's efficacy.

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Guowei Fang, President of R&D, provided details on the survey, noting it was 86% community-based and geographically diverse. Alan Bash, President of CARVYKTI, stated the updated EU label is expected to drive earlier-line use and clarified that the 30-day median turnaround time is a relevant metric for physicians due to bridging therapy schedules. He did not provide a specific outpatient breakdown by disease stage but noted a correlation with earlier-line use.

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Executive Alan Bash acknowledged that Europe is still a supply-constrained environment and that the company is working to keep up with growing demand. He noted the Ghent facility is now delivering at full capacity and the Tech Lane facility will have commercial approval by the end of 2025. Executive Jessie Yeung stated that R&D spending remains disciplined and flattish, and while spending for BCMA may remain similar for now, a decline could be seen in 2027.

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CEO Ying Huang attributed the rapid approval to high-quality operations and clarified that the EMA does not regulate capacity like the FDA, so stepwise increases are not needed in Europe. He reiterated the goal of 10,000+ doses/year capacity by late 2025. SVP Steven Gavel outlined the frontline strategy, which involves expanding their commercial reach into the community setting and engaging patient advocacy groups, building on the current second-line launch model.

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CEO Liz Barrett confirmed the FDA review team remains the same as it was for JELMYTO. She also verified that the 18-month data has already been shared with the FDA and is incorporated into all discussions. Regarding marketing, she stated that while broad-based DTC is not planned initially, they will have robust patient engagement programs to ensure patients are part of the treatment discussion.

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CEO Punit Dhillon expressed confidence that investors now better grasp Nimacimab's differentiation due to recent preclinical data showing comparable efficacy to Monlunabant and additive effects with tirzepatide. CSO Chris Twitty detailed that the ECO presentation will model peripheral vs. central CB1 inhibition, while ADA will feature more in-depth biomarker and combination data. Dr. Puneet Arora added that the company plans to use the Phase 2a data to engage the FDA on a definitive Phase 2b dose-ranging study and discuss target populations.

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Executive Puneet Arora explained that the DSMB reviews all unblinded data, including neuropsychiatric events, and has the authority to recommend study modifications or stoppage, but has so far recommended continuing as planned. He affirmed the belief that neuropsychiatric effects are CNS-mediated, based on models showing they correlate with brain concentration. He also clarified that in the extension, placebo patients will cross over to receive open-label nimacimab.

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President and CEO Punit Dhillon confirmed the company's proprietary DIO mouse model is operational and will be used to expand the preclinical dataset, including evaluating combinations. Executive Christopher Twitty added that their expanded homozygous colony enables a series of new studies. They are considering comparisons against other anti-obesity medications, including small molecule inhibitors, and will investigate mechanistic biomarkers beyond weight loss, while maintaining a primary focus on executing the ongoing clinical program.

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Dr. CJ Barnum, Head of Neuroscience, explained that EMAC is a more sensitive tool than the 'blunt instrument' of CDR, and any discrepancy would likely be a statistical power issue, which he believes experts would understand. CEO RJ Tesi noted that APOE4 homozygotes constitute 9% of their trial, comparable to the 15% in larger studies, representing a key unmet need. Regarding pTau217, Dr. Barnum stated that direct comparisons are difficult but highlighted that XPro showed robust changes in CSF early, a unique finding for a neuroinflammation-focused drug.

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Dr. Mark Lowdell, Chief Scientific Officer, stated that while INmune Bio believes the existing Mission EB data is sufficient for a BLA submission, the open-label trial will provide valuable data on effect persistence and optimal dosing. He confirmed they are also preparing for MHRA submission. CEO Dr. RJ Tesi and Dr. Lowdell clarified that data for both the EMACC and CDR endpoints will be released simultaneously in June.

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Head of Neuroscience Dr. CJ Barnum stated the depression trial will use C-reactive protein and anhedonia as biomarkers. Regarding INKmune, an executive (presumably Dr. Mark Lowdell) explained that for a Phase I trial, demonstrating an immunological response is key, and any clinical response deemed convincing by the chief investigator would be a positive signal. CEO Dr. RJ Tesi added that prolonging life with good quality of life is also a critical metric.

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CEO Michael Metzger acknowledged that the KMT2A market could be larger than the 2,000 patients currently estimated, though it's too early to confirm. He affirmed the expectation that post-transplant maintenance use will be reimbursed. He also confirmed the sNDA for NPM1 was submitted with the 77-patient efficacy evaluable data set presented at ASH.

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CSO Dr. Anjali Ganguli cited sorafenib and gilteritinib as precedents for securing NCCN listing based on Phase II data. President and Head of R&D Dr. Neil Gallagher stated that revumenib has been well-tolerated at both doses tested in combinations, giving them choices, and that they are currently combining it at full dose, with more data to be reported later in the year.

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CEO Michael Metzger stated there are no plans to update the KMT2A data again before approval and that the Hovan trial timeline is not yet defined. He affirmed his belief that Royalty Pharma's valuation considered all potential indications, including GVHD and IPF, leading to a deal that reflects a robust forecast.

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CEO Troy Wilson expressed confidence but noted they must wait for formal FDA notification on priority review. He added that an ODAC meeting is unlikely due to the palliative setting and the drug's strong safety profile. Executive Mollie Leoni clarified the Phase 3 trials have 'dual primary' endpoints, meaning the trial can succeed on either the accelerated approval endpoint (MRD-negative CR) or the survival-based endpoint (EFS/OS) independently.

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CEO Troy Wilson clarified that the data packages are contemporaneous and the core results will be consistent. He and CMO Dr. Mollie Leoni explained the FDA's willingness to consider the MRD endpoint is based on collaborative work with the IMPACT Consortium and is not unprecedented. Mr. Wilson noted that guidance on the EFS endpoint timing will be provided later in the year.

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CEO Dr. Troy Wilson explained the diabetes candidate will prioritize an even higher safety and tolerability profile suitable for a less sick patient population. He also highlighted ziftomenib's durable epigenetic effects as a key feature. SVP of Finance and Accounting, Tom Doyle, confirmed that the company's cash runway guidance into 2027 includes the planned early clinical work for this next-generation program.

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Executive Dennis Williams clarified that while Adaptimmune is part of the EU's PRIME scheme, the company will likely submit its marketing application after receiving full trial results in Q3 to strengthen the filing. CEO Adrian Rawcliffe confirmed significant industry interest and ongoing discussions for the PRAME and CD70 programs but reiterated that they are part of a broader strategic review to secure financing for the company.

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CEO Adrian Rawcliffe cautioned against over-interpreting the duration of response data, noting its variability and that the Tecelra label data differs from the Lancet publication. Executive Dennis Williams confirmed there have been no new Grade 5 T-cell related events since ASCO. Regarding executives, Rawcliffe stated the company is still working through the organizational impact.

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Executive Dennis Williams explained that MRCLS was not pursued for the Tecelra label due to the very small number of patients in the pivotal trial, making lete-cel a more appropriate future therapy for that indication. Executive John Lunger clarified that lete-cel trial manufacturing was in Germany and, for speed, the supply chain won't change for the initial filing, but a U.S. site is planned for the future.

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CEO Barry Greene confirmed it was a 'direct effort' of their government affairs team. He explained that maternal health is a bipartisan priority, and the strong pharmacoeconomic argument for treating PPD resonates with policymakers. He indicated that what happened in Louisiana is a dynamic they will likely see in other states.

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President and CEO Dinesh Patel and Chief Medical Officer Samuel Saks clarified that while they have the safety clearance to explore higher doses, it would likely only be considered for beta-thalassemia due to its high iron overload. Mr. Patel emphasized that a sustained impact on transfusion burden, not just biomarker changes, is the key endpoint for the beta-thalassemia study. He also explained that learnings from the high placebo effect in the PTG-100 study have led to risk mitigation strategies for the PN-943 trial, including using a different CRO and extensive KOL consultation.

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