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CEO Dr. David Chang stated that the MRD testing window is standardized and not expected to impact outcomes. CMO Dr. Zachary Roberts added that since ALPHA-three is a pioneering study for prospective MRD clearance, they are using the second-line relapse setting as a benchmark for efficacy, which they believe is an achievable bar.

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CEO Christian Itin noted that high-volume centers have shown phenomenal engagement and that repeat use is a key metric being monitored. He hopes for a resolution in the UK in the next few months, potentially leading to a launch late this year or early next, but is not guiding to German sales yet. For the ACR update, he expects longer follow-up on the initial six SLE patients and early data from new patients, supported by extensive translational analysis.

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CEO Christian Itin stated that the pivotal study in lupus nephritis is planned to be a relatively compact trial enrolling approximately 30 patients. He indicated that while a one-year follow-up period is meaningful for these patients, the primary readout for a fast-to-market strategy could potentially be based on a shorter duration, given the observed response dynamics.

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CEO Nello Mainolfi and CMO Jared Gollob explained that if conjunctivitis is a true on-mechanism effect of IL-4/13 pathway blockade, they would expect to see it. They noted it hasn't appeared in preclinical or healthy volunteer studies and have no reason to expect a different rate than dupilumab. Nello Mainolfi added that he doesn't see why the pathway blockade would be different from an antibody and highlighted KT-621's exceptional tolerability in long-term tox studies.

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CEO Nello Mainolfi confirmed that several time points will be measured but cautioned against over-relying on healthy volunteer biomarker data for dose selection, citing dupilumab's data as an example. He reiterated that the key criteria for dose selection are robust STAT6 degradation (90%+) and a safe, well-tolerated profile.

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Interim CFO Jessie Yeung confirmed that earlier-line treatment improves the safety profile, with Parkinsonism rates dropping from 6% in CARTITUDE-1 to 1% in CARTITUDE-4, largely due to better bridging therapy options. President of CARVYKTI Alan Bash added that earlier treatment also leads to fitter T-cells, lower out-of-spec rates, and better efficacy. CEO Ying Huang noted the percentage incidence rate of neurotoxicities is decreasing.

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Alan Bash, President of CARVYKTI, confirmed the Tech Lane facility is on track for commercial production by year-end, supporting European launches, and mentioned a joint $150 million investment for further capacity. Guowei Fang, President of R&D, detailed the in vivo CAR-T platform's advantages, including better T-cell phenotype, an off-the-shelf approach without lymphodepletion, and scalable manufacturing.

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Executive Jessie Yeung noted that bispecifics are approved in later lines and their trials exclude prior BCMA agents, reinforcing the IMWG recommendation for CAR-T first in eligible patients. Executive Ying Huang emphasized CARVYKTI's unmatched benefits, including the depth and durability of response and the convenience of a one-time treatment that provides a long treatment-free period and improved quality of life.

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President & CEO Jan Møller Mikkelsen noted that while they lack precise real-world data on titration duration, the process appears successful given low patient dropout rates. He clarified that the current U.S. approval is for doses up to 30mcg. A trial to support a 60mcg dose has been initiated, but it is too early to comment on the pricing or reimbursement for a potential higher dose.

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President and CEO Jan Mikkelsen clarified that patient severity (e.g., controlled vs. uncontrolled) is not a factor in reimbursement discussions. He emphasized that the primary driver for uptake is the profound personal benefit patients experience, rather than long-term health economic outcomes. Chief Medical Officer Aimee Shu added that existing literature on the benefits of reducing conventional therapy might preclude the need for a new trial.

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CBO Eric Pauwels explained that access speed for Sefiance depends on the patient's profile, with previously documented failures potentially moving through payer approvals more quickly. CFO Pierre Gravier confirmed the $650M-$800M guidance includes new product launches, with the upper end allowing for potential upside. CEO Dr. Matthew Klein reported a constructive late-cycle meeting for vutiquinone, where the FDA confirmed the application is under active review.

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CEO Dr. Matthew Klein noted Sephience shows superior phenylalanine lowering even in patients on existing therapy. CBO Eric Pauwels added that payer research indicates they view Sephience as highly differentiated and superior, with diet liberalization being a key factor. He anticipates minimal reimbursement hurdles due to the large untreated or failed-treatment patient population.

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CEO Matthew Klein highlighted that the strong Q3 results prompted an increase in the full-year 2024 revenue guidance to $750-$800 million. He anticipates continued strong contributions in Q4, with Emflaza performing well against generic competition and Translarna revenue expected to be stable, though subject to typical quarterly lumpiness.

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CEO William Lewis affirmed that the initial market size estimate of 250,000 patients is based on data showing documented exacerbations. He highlighted the larger, untapped opportunity in patients with comorbid COPD or asthma who have not yet been diagnosed with bronchiectasis via a CT scan. He believes the availability of an approved treatment will incentivize physicians to conduct more CT scans, thereby expanding the diagnosed population.

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CEO Mark Goldsmith declined to provide specific updates on regulatory interactions, stating it's not typically helpful. However, he emphasized that the company is making very good progress and reiterated the timeline for initiating the trial, implying that necessary steps are being successfully completed.

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Dr. Mark Goldsmith, Chairman and CEO, responded that Tango's compound is interesting and that positive preclinical data from their joint work supported the collaboration. However, he emphasized that this partnership does not preclude future collaborations with other PRMT5 inhibitors, as the company is actively seeking the best combination partners and it is too early to make a final determination.

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Pravin Dugel, Executive Chairman, President & CEO, explained the extension study is a strategic effort to generate long-term data on non-pulsatile dosing and support a superiority claim. He argued that the key to market dominance is not just hitting a specific visual acuity number but achieving a superiority label, which would place axpaxly in a 'different orbit' from competitors and protect it from pricing pressures.

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CFO & Chief Business Officer Arthur Stril explained the R&D Day will feature the full Phase I dataset for lasmacell, including safety, efficacy, and durability, as well as the late-stage development strategy and Phase II design. Chief Medical Officer Dr. Adrian Kilcoyne confirmed that regulatory interactions revealed no barriers to proceeding, with both the FDA and EMA acknowledging the high unmet need and showing broad support for the company's plans.

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CMO Dr. Adrian Kilcoyne responded that for UCART22, enrollment for the Phase I portion is complete, having reached the necessary patient numbers (up to 40 planned) for the end-of-phase analysis. He noted that patient numbers for the pivotal Phase II study will depend on regulatory alignment but are expected to be realistic for the indication.

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CCO Steve Closter stated that the average treatment duration is tracking within the projected four-to-six-month range for the first year and is expected to expand to six-to-twelve months in the second year as the drug is used earlier. CFO Keith Goldan clarified expense guidance, indicating that Q3 operating expenses (less non-cash stock comp) are projected to be $95-$100 million, with Q4 expected to be at a similar level.

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President and Head of R&D Dr. Neil Gallagher explained that for unfit patients, FLT3 status is not a selection criterion, but for fit patients, an approved FLT3 inhibitor is typically used first. CCO Steven Closter reported that physician feedback on the overall profile is "great," with safety aspects being well-understood and manageable, supported by the company's clinical nurse educators.

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Chief Medical Officer Dr. Allen Yang confirmed that HARMONi-3 has enrollment objectives for both histologies to ensure sufficient data, with an expected near-equal split between squamous and non-squamous patients. Regarding HARMONi-7, executive Dave Gancarz noted a hazard ratio around or under 0.80 is a key focus. Dr. Jack West added that if the trial is statistically positive as designed, it will be considered clinically meaningful and practice-changing, as clinicians generally look for a 2-3 month OS improvement as a benchmark.

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Chief Medical Officer Dr. Allen Yang confirmed HARMONi-3 has enrollment objectives for both histologies to ensure sufficient data, aiming for a roughly equal split. Executive Dave Gancarz noted the company targets an OS hazard ratio around or under 0.80. Dr. H. Jack West, VP, and Dr. Yang added that if the trial is positive as designed, it will be clinically meaningful and practice-changing, with a 2-3 month OS improvement being a general benchmark for clinicians.

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Dr. Allen Yang, Chief Medical Officer, confirmed the primary analysis for the HARMONi trial is planned for the total study population, although regional differences will be examined. An executive clarified that 'mid-year' refers to a broader Q2/Q3 2025 timeframe. Regarding new trial arms, an executive stated they are exploring all opportunities to accelerate development and believe EV is important in bladder cancer, promising more details in the coming months.

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Lai Wang, Global Head of R&D, clarified that for both single-arm Phase II studies, the primary endpoints are Overall Response Rate (ORR) and Duration of Response (DOR), which can support accelerated approval. He added that the sonrotoclax filing in China has received priority review, with a potential approval anticipated in the first half of 2026.

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Wang Lai, Global Head of R&D, explained that both are single-arm Phase II studies where the primary endpoints are Overall Response Rate (ORR) and Duration of Response (DOR), which could support accelerated approval. For the sonrotoclax filing in China, he noted it has received priority review and anticipates a potential approval in the first half of the next year.

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Executive Eric Sievers explained the dose escalation schema for BA-3182, noting they are in a dose zone showing meaningful tumor control, consistent with animal models. He confirmed that two of three patients in Cohort C4 have cleared the DLT window, with the third expected to clear in early April, and expressed enthusiasm for reporting the full Phase 1 data set in the coming months.

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CEO Ameet Mallik stated that the company hopes to see additive or synergistic efficacy from the LOTIS-7 combination due to the complementary mechanisms of a CD19 ADC and a CD20/CD3 bispecific. He also highlighted the potential for ZYNLONTA to debulk tumors and reduce CRS severity. He confirmed that the trial includes both academic and large community centers to ensure the patient sample is representative of real-world settings.

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Steven Stein, an executive, explained that the mild-to-moderate HS patient population can have a notable placebo effect. Using the higher bar of HiSCR 75 as the endpoint helps control for this placebo response, addresses the significant unmet need, and increases the probability of a successful trial outcome. He confirmed this endpoint was agreed upon with regulatory agencies.

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CEO Garo Armen explained that he would not disclose specific details to protect the confidentiality of the process. However, he characterized the European agency's stance as 'diametrically opposite' to the U.S. FDA's, noting they were much more positive. He added that the European agency had reviewed more mature data and provided helpful guidance for a rapid submission pathway, suggesting procedural requirements would not impede progress.

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CEO Raj Kannan expressed excitement for the drug's potential in the growing China market. CMO John Hayslip confirmed its safety profile from the head-to-head trial against Norditropin was favorable. President and Head of R&D Andrew Zhu added that the safety is comparable to the daily injection and that the company is actively pursuing a BLA submission, with a more detailed timeline to be announced later.

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Jingwu Zang, Founder and Chairman, confirmed that the delisting risk has been largely mitigated due to new PCAOB rules. Andrew Zhu, Acting CEO, clarified that the 70-patient cohort for the uliledlimab trial specifically enrolled treatment-naive Stage 4 non-small cell lung cancer patients who had not received prior treatments, including PD-1 therapy.

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Jingwu Zang, Founder, Chairman and Acting CEO, explained that details of the new CD47 molecule are confidential under the AbbVie agreement, but highlighted the potential for $1.3 billion in milestones and that I-Mab retains China rights. He reaffirmed commitment to advancing lemzoparlimab in China. Andrew Zhu, President, added that the Phase 3 MDS trial design is under active discussion with the CDE, with a target initiation by the end of 2022.

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Andrew Zhu, President, confirmed that in a cohort of 22 patients treated for at least four months, the ORR and CR rates for lemzoparlimab with AZA were comparable to magrolimab's reported data. He emphasized a better safety profile, noting no unexpected signals or Grade 5 hematological TEAEs, and attributed this to the molecule's unique design. Dr. Zhu outlined plans to present full data at a scientific congress like ESMO or ASH, with additional data for NHL and solid tumor combinations expected at ASH and SITC, respectively.

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President and CEO Dr. Todd Brady indicated that after a Phase 1 trial, ADX-246 might inherit indications currently being tested with ADX-629, such as chronic cough or atopic dermatitis, particularly for mass-market applications. Interim CFO Bruce Greenberg clarified that the cash runway guidance into the second half of 2024 is conservative and does not include any projected product revenue or income from potential licensing arrangements.

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President & CEO Dr. Todd Brady explained that while the GUARD trial uses about 13 injections, more recent literature suggests less frequent dosing may be effective. He noted the trial's discontinuation rate is acceptable, as patients are highly motivated to prevent sight loss. For the regulatory bar, he stated that after the GUARD results are released, Aldeyra will have a Type C meeting with the FDA. He anticipates the FDA will consider the GUARD results alongside the growing body of real-world data and literature on methotrexate for PVR. The trial's primary endpoint aims to be statistically lower than the standard of care's ~40% re-detachment rate.

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CEO Dr. Todd Brady emphasized that reproxalap's key competitive advantage and the core of its differentiation strategy is its rapid onset of action for symptom relief, which is what matters most to physicians and patients. He highlighted head-to-head data showing patients feel better in as little as 90 seconds. He noted that while physician preferences for signs (redness vs. Schirmer) may vary, the rapid symptom improvement will be the primary driver of adoption, regardless of which sign is on the label.

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Chief Medical Officer Dr. Chin Lee confirmed a successful FDA meeting focused on the Phase 3 program design and noted strategies to enroll a more severe patient population in the upcoming global trial. He explained the nasal polyp trial was terminated due to operational challenges, not safety. Co-Founder and CEO Dr. Zheng Wei added that pursuing additional indications like nasal polyps is part of the long-term strategy to maximize CBP-201's value, likely to be pursued by a future partner.

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