Emily Bodnar

Emily Bodnar asked about expanding the combination therapy cohort for agenT-797 in solid tumors, initiating dose expansion in tumor types showing most benefit, and details regarding the timing and funding for the severe pulmonary disease trial launch.

Answer

Dr. Jennifer Buell (President and CEO, MiNK Therapeutics) explained that the data supports expanding the combination cohort, particularly in patients who failed prior PD-1 therapy, and mentioned an upcoming externally financed phase two study for specific tumor types like second-line gastric cancer and testicular cancer. She also stated that the severe pulmonary disease trial is in the activation phase, targeting first patient dosing by early next year. Dr. Therese Hammond (Head of Development, MiNK Therapeutics) added that the pulmonary trial will use established endpoints like 28-day mortality and will look at a broad population of patients with severe pneumonia and hypoxemic respiratory failure.

Emily Bodnar with H.C. Wainwright inquired about the potential expansion of the agenT-797 combination cohort in solid tumors, including specific tumor types for dose expansion, and requested an update on the launch timing and funding for the severe pulmonary disease trial.

Answer

President and CEO Jennifer Buell detailed plans for an externally financed Phase 2 expansion targeting PD-1 refractory patients, specifically mentioning ongoing studies in second-line gastric cancer and potential rapid development pathways in testicular cancer. She also confirmed the severe pulmonary disease trial is in the activation phase, targeting first patient dosing by early Q1 next year.

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.

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.

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.

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.

Emily Bodnar inquired about what management considers a realistic long-term usage split between first/second-line and third-line plus for Rytello, and asked about the typical treatments used prior to Rytello in third-line cases.

Answer

Jim Ziegler, EVP & CCO, avoided giving a specific percentage target to not provide guidance but affirmed the goal is to increase use in the approved first-line ESA-ineligible and second-line populations. He identified ESAs and luspatercept as common preceding therapies and stressed Rytello's differentiated profile as a competitive advantage.

Emily Bodnar of H.C. Wainwright asked for the reasons why one-third of initial RYTELO prescribers have not reordered and whether discontinuation rates align with clinical trial data. She also inquired about the upcoming IMproveMF data at ASCO.

Answer

Dr. Joseph Eid, EVP of R&D, explained that commercial discontinuation and dose interruption experiences appear consistent with the IMerge trial, often related to manageable cytopenias. James Ziegler, CCO, addressed the ASCO update, noting that the IMproveMF study's second cohort is enrolling at maximum tolerated doses of both drugs, which showed fewer cytopenias, and that the trial is expanding to include combinations with other JAK inhibitors.

Emily Bodnar of H.C. Wainwright asked whether new patient starts were primarily from existing prescribers or new ones. She also inquired about factors contributing to the enrollment pace in the IMpactMF myelofibrosis trial and if there was a timeline for full enrollment.

Answer

Jim Ziegler, CCO, explained that new starts show depth from repeat prescriptions at academic centers and breadth from new prescribers in the community. Dr. Faye Feller, Chief Medical Officer, stated that enrollment in the IMpactMF trial is proceeding steadily and as expected. She clarified that the trial's key analysis timelines are event-driven and not strictly dependent on the date of full enrollment, for which no public timeline has been provided.

Emily Bodnar of H.C. Wainwright inquired about the initial real-world experience with RYTELO's efficacy and safety compared to the EMERGE study, and the market impact of luspatercept's use in the first-line setting.

Answer

EVP & CCO Jim Ziegler noted that while it is still early, real-world performance appears consistent with clinical trial data. He asserted that RYTELO is positioned to become the standard of care in the second line, regardless of whether patients receive ESAs or luspatercept first. EVP & CMO Dr. Faye Feller added that physicians seem comfortable managing the known cytopenias.

Emily Bodnar of H.C. Wainwright & Co. inquired about the initial patient demand for the OVATION III trial, the expected pace of enrollment for the HRD subset, and the outlook for operating expenses for the remainder of the year.

Answer

Chief Medical Officer Dr. Douglas Faller addressed patient demand, highlighting the high unmet need in frontline ovarian cancer and the failure of recent checkpoint inhibitor trials, which makes ImmuNon's IL-12 approach more appealing. He noted that the HRD-positive population represents about 50% of frontline patients. President and CEO Dr. Stacy Lindborg explained that operating expenses have declined due to the conclusion of other trials and that OVATION III startup costs were incurred in advance, leading to expectations of relatively stable expenses moving forward.

Emily Bodnar inquired about the financing strategy for the Phase III study of IMNN-001, potential partnership interest since the OVATION 2 data release, and the design and data visibility of the Phase I COVID booster trial.

Answer

CEO Stacy Lindborg estimated the Phase III trial cost at approximately $50 million, noting the recent financing provides a cash runway into Q3 2025, serving as a bridge to raise additional capital. Executive Chairman Michael H. Tardugno added that while top-tier investors showed positive interest, they await more mature data, and the company may use its ATM, seek partners, or conduct another equity round. Regarding the COVID study, Stacy Lindborg clarified it is an open-label trial with full data expected by year-end, and Michael H. Tardugno confirmed that a DSMB is actively monitoring safety.

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.

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.

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.

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.

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.

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.

Emily Bodnar inquired about the maturity of the BOT/BAL Phase II study data, specifically the length of follow-up, whether the overall survival endpoint has been met, and the company's contingency plans for a Phase III trial if required by the FDA.

Answer

Dr. Steven O’Day, Chief Medical Officer, stated that they will have approximately one additional year of data since the last FDA submission, with median follow-up now at 18 months for Phase I and over 12 months for Phase II. CEO Garo Armen emphasized that the longer-term follow-up is strongly indicative of a survival benefit. Dr. Jennifer Buell, Chairman of the Executive Board, added that they are presenting two different randomized Phase III designs to the agency and have received interest from third parties to help accelerate development.

Emily Bodnar inquired about the specifics of Agenus's cost reductions, asking which R&D programs were most affected, and also requested an overview of expected catalysts for 2025, including any new data or regulatory updates.

Answer

Chairman and CEO Garo Armen explained that cost reductions are centered on nonessential headcount and external advisors to prioritize the BOT/BAL program. He noted that other pipeline products have been temporarily shelved, not terminated, and can be reactivated later. Regarding 2025 catalysts and regulatory updates, he advised analysts to 'stay tuned.'

Emily Bodnar inquired about the design, next steps, and timelines for the BOT/BAL Phase III study, details on other neoadjuvant studies, expectations for early 2025 data, and an update on the Phase II relapsed/refractory colorectal cancer (CRC) data timeline.

Answer

Dr. Robin Taylor, Chief Commercial Officer, stated that Agenus has feedback from the EMA and FDA and is now focused on securing financing or a partnership to initiate the Phase III study. Dr. Steven O’Day, Chief Medical Officer, added that two new European data sets for neoadjuvant BOT/BAL will be presented in early 2025, one in CRC and another in a broader set of solid tumors. He also confirmed the maturing Phase II refractory CRC data will be presented at a conference in early 2025.

Emily Bodnar of H.C. Wainwright & Co. inquired about the specifics of the planned Phase III trial design for BOT/BAL, including patient numbers and endpoints. She also asked about the potential initiation timeline and whether Agenus has the financial resources to conduct the trial independently. Additionally, she sought confirmation on the timing and scope of upcoming data releases for pancreatic and melanoma cancers.

Answer

CEO Garo Armen stated that a Phase III trial could commence within the next four months and enroll within a year, citing strong global patient demand. He mentioned exploring a partnership that could fund a global trial for as little as $10 million. Armen also confirmed that maturing data for pancreatic, melanoma, lung, and neoadjuvant cancers are expected to be disclosed in the coming months.

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.

Emily Bodnar of H.C. Wainwright & Co. inquired about the timeline for initiating a study in the metastatic setting, whether it would be a Phase II or Phase III trial, and requested an update on the EVANGELINE trial's enrollment and data timing. She also asked for the rationale behind the different primary endpoint durations for the monotherapy (24 weeks) versus the combination therapy (4 weeks) arms.

Answer

Dr. Steven Quay, Chairman, CEO, and President, explained that it was premature to detail the metastatic study's phase or timing, as the company is currently consulting with key opinion leaders before engaging with the FDA over the next 4 to 6 months. He noted that updates on EVANGELINE trial enrollment and interim data would be provided at upcoming medical meetings. Dr. Quay clarified that the 4-week endpoint for the combination arm is based on regulatory requirements for an early assessment of Ki-67 values.

Emily Bodnar of H.C. Wainwright & Co. inquired about the timeline for initiating a study for Z-endoxifen in the metastatic breast cancer setting, the enrollment status of the EVANGELINE trial, and the rationale for different primary endpoint durations in the trial's arms.

Answer

Dr. Steven Quay, Chairman, CEO, and President, stated that the metastatic study timeline will be determined over the next 4-6 months following consultations with key opinion leaders and the FDA. He mentioned that updates on EVANGELINE enrollment and interim data would be provided at upcoming meetings and explained the different endpoint durations are due to requirements for an early data review in one arm of the trial.

Asked for clarification on the patient numbers in the new 70mg lonigutamab cohort, whether this is sufficient for Phase III dose selection, and for an update on hearing-related side effects.

Answer

The 70mg cohort has 8 patients with flexibility to expand to 16, testing both Q3W and Q4W regimens. The company believes the totality of Phase II data will be sufficient to inform the Phase III dose. No notable hearing impairment has been observed, only a few resolved cases of transient tinnitus in an early cohort.

Emily Bodnar from H.C. Wainwright & Co. inquired about the trial design for VTX3232 in Parkinson's disease, specifically the neurodegenerative markers and disease-rating scores being evaluated, and also asked for details on the obesity study design, such as patient numbers and exclusion criteria.

Answer

CEO Raju Mohan clarified that while trial specifics will be on ClinicalTrials.gov, the Parkinson's study will include an imaging component and assess NLRP3-related biomarkers (IL-1 beta, hsCRP, IL-6) and neurodegenerative markers like neurofilament light chain. He stated that significant effects on motor symptoms are not expected in a short trial, which is why a longer trial is planned for later in the year.