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    Emily Bodnar • H.C. Wainwright & Co.

    Emily Bodnar's questions to Mink Therapeutics Inc (INKT) leadership

    Emily Bodnar's questions to Mink Therapeutics Inc (INKT) leadership • Q2 2025

    Question

    Emily Bodnar from H.C. Wainwright & Co. inquired about the financial scope of the two grants for the GVHD program, asking what percentage of trial costs they would cover. She also requested more details on the planned Phase 2/3 trial in ARDS and its potential registrational pathway.

    Answer

    President and CEO Dr. Jennifer Buell stated that the GVHD trials are "fully funded" by the grants, though Mink retains the discretion to add capital for ancillary studies. Regarding the ARDS trial, she explained it will be designed for FDA registration with a primary endpoint of 28-day mortality and secondary endpoints including prevention of infections and ventilator-free days, building on prior data showing significant survival benefits.

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    Emily Bodnar's questions to Mink Therapeutics Inc (INKT) leadership • Q1 2025

    Question

    Emily Bodnar inquired about the testicular cancer patient's complete response (CR) timeline, the company's future plans for this indication, the expected timing for Phase II gastric trial data, and potential delays in government funding from the NIAID.

    Answer

    President and CEO Dr. Jennifer Buell explained that the testicular cancer patient's CR was formally observed 24 months after a single infusion of AgenT-797, with no other treatment administered. For the Phase II gastric trial, she stated they are targeting data release in the second half of the year, with early next year being the latest possible timeframe. Regarding funding, Dr. Buell acknowledged past delays but noted recent reassurance from NIAID, with a conclusive decision on the probable funding expected by June.

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    Emily Bodnar's questions to Mink Therapeutics Inc (INKT) leadership • Q4 2024

    Question

    Emily Bodnar inquired about the enrollment status and data release timeline for the AGENT-797 Phase II study in gastric cancer, and asked about the company's primary clinical focus for 2025 between gastric cancer, GvHD, and other pipeline programs.

    Answer

    President and CEO Dr. Jennifer Buell confirmed that the primary focus for 2025 is advancing AGENT-797 in both gastric cancer and GvHD. She stated the gastric cancer trial is majority enrolled, with clinical data expected in the second half of the year. Dr. Buell also highlighted that the next-generation IL-15 armored CAR iNKT program (215) is advancing through IND-enabling studies with a filing planned for 2025.

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    Emily Bodnar's questions to Mink Therapeutics Inc (INKT) leadership • Q3 2024

    Question

    Emily Bodnar of H.C. Wainwright & Co. inquired about the enrollment progress for the Phase II gastric cancer study, the expected scope of the data update in early 2025, and the drivers behind the significant decline in R&D expenses.

    Answer

    President and CEO Dr. Jennifer Buell stated that the gastric cancer trial is nearly halfway enrolled, with promising early signals of clinical activity and tolerability. She noted that a significant data update will be presented at a major conference in early 2025. Regarding R&D expenses, Dr. Buell explained that major cost reductions stem from manufacturing efficiencies, specifically increased scalability from a single donor, which has substantially lowered the cost of starting materials for cell production.

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    Emily Bodnar's questions to Agios Pharmaceuticals Inc (AGIO) leadership

    Emily Bodnar's questions to Agios Pharmaceuticals Inc (AGIO) leadership • Q2 2025

    Question

    Emily Bodnar from H.C. Wainwright & Co. asked about the pediatric opportunity for Pyrokine in thalassemia, including potential filing timelines, and inquired if there have been any changes in interactions with the FDA recently.

    Answer

    CCO Tsveta Milanova noted a pediatric population of 2,000 patients. CMO Dr. Sarah Gheuens explained that pediatric trials will be run after the adult profile is established, similar to the PKD strategy. Dr. Gheuens also confirmed that the company has not experienced major disruptions in its collaborative engagement with the FDA.

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    Emily Bodnar's questions to Agios Pharmaceuticals Inc (AGIO) leadership • Q1 2025

    Question

    Emily Bodnar of H.C. Wainwright & Co. asked about the company's marketing strategy for PYRUKYND in thalassemia, specifically how it will differ for non-transfusion-dependent patients versus transfusion-dependent patients.

    Answer

    CCO Tsveta Milanova stated that the commercial team is launch-ready and will target both patient populations. She noted that disease state education is heavily focused on non-transfusion-dependent (NTD) patients. The initial launch focus will be on transfusion-dependent patients and the subset of NTD patients with low hemoglobin, complications, or debilitating fatigue, as these individuals are already actively engaged with the healthcare system and are likely to be early adopters.

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    Emily Bodnar's questions to Novocure Ltd (NVCR) leadership

    Emily Bodnar's questions to Novocure Ltd (NVCR) leadership • Q2 2025

    Question

    Emily Bodnar from H.C. Wainwright & Co. sought clarification on whether the reported U.S. sales figure included OptuneLua revenue and asked about the potential for case-by-case reimbursement in Germany. She also inquired about any early data on real-world efficacy for lung cancer.

    Answer

    CEO Ashley Cordova confirmed that the $94 million U.S. revenue figure is inclusive of all products, including OptuneLua, and that Germany will follow a similar case-by-case reimbursement path as the U.S. Frank Leonard, EVP & President - Novocure Oncology, added that while they cannot track hard clinical endpoints in real-time, device usage is consistent with trial data.

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    Emily Bodnar's questions to Novocure Ltd (NVCR) leadership • Q1 2025

    Question

    Emily Bodnar asked how the NSCLC launch ramp in Germany might compare to the U.S. and how to model 2025 U.S. lung cancer revenue given that reimbursement and cash collection are already occurring.

    Answer

    Executive Frank Leonard explained the German launch strategy will mirror the U.S. due to similar market dynamics. CFO Christoph Brackmann reiterated that NSCLC revenue will reflect cash collections, while CEO Ashley Cordova added that the ability to complete the cash collection cycle within a quarter is a promising early sign for reimbursement.

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    Emily Bodnar's questions to Novocure Ltd (NVCR) leadership • Q4 2024

    Question

    Emily Bodnar inquired about the clinical profile of the initial lung cancer patients, specifically whether they were PD-1 naive or experienced, and whether they were receiving docetaxel, PD-1 inhibitors, or both as concomitant therapy.

    Answer

    Executive Frank Leonard confirmed that the initial patient cohort includes a mix of demographics and that the company is seeing patients receive Tumor Treating Fields concurrently with both docetaxel and immune checkpoint inhibitors. He also noted this includes patients being retreated with or continuing on an ICI from a prior line of therapy.

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    Emily Bodnar's questions to Novocure Ltd (NVCR) leadership • Q3 2024

    Question

    Emily Bodnar from H.C. Wainwright & Co. asked about Novocure's marketing strategy for lung cancer patients previously treated with checkpoint inhibitors and the initial physician feedback. Additionally, she requested an update on the data readout timelines for the LUNAR-2 and LUNAR-4 studies.

    Answer

    An executive, Frank Leonard, explained that the broad FDA label allows for concurrent use with checkpoint inhibitors and that physicians clearly recognize the high unmet need in this patient population, leading to strong initial engagement. Another executive, Nicolas Leupin, confirmed that the LUNAR-2 and LUNAR-4 trials are actively recruiting and have generated momentum among investigators, but he did not provide specific timelines for data availability.

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    Emily Bodnar's questions to Arcus Biosciences Inc (RCUS) leadership

    Emily Bodnar's questions to Arcus Biosciences Inc (RCUS) leadership • Q1 2025

    Question

    Emily Bodnar asked for an update on the casdatifan 100mg QD monotherapy cohort's progress relative to the 50mg BID cohort, specifically regarding median PFS, and inquired about any timing updates for the STAR-121 trial in lung cancer.

    Answer

    CEO Terry Rosen responded that there was no new update on the casdatifan cohorts as median PFS has not yet been reached, but data, potentially including a landmark PFS, would be shared by year-end. For the STAR-121 trial, he stated it is premature to provide a timing update as the study is still enrolling and has a long OS endpoint for the standard of care.

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