Asthika Goonewardene

Asthika Goonewardene of Truist Securities asked about the plan for adding more Authorized Treatment Centers (ATCs) and their productivity, the financial impact of out-of-spec products on COGS, and the potential for cross-border patient travel in Europe for Ocatsol treatment.

Answer

CEO Christian Itin explained the strategy for ATC expansion focuses on centers with high patient flow and ensuring broad geographic access. He also noted that cross-border treatment does occur in Europe, a possibility Autolus is exploring. CFO Rob Dolski clarified that out-of-spec product costs can land in either R&D or COGS, and the rate has been consistent with the 5-10% range seen in the Felix study.

Karina Rabayeva, on behalf of Asthika Goonewardene from Truist, asked for commentary on the market dynamics with Gilead's Tecartus following its sales decline and requested details on AUCATZYL's current manufacturing turnaround time and success rate.

Answer

CEO Christian Itin stated it is difficult to parse the competitive impact, as Tecartus sales include both adult ALL and mantle cell lymphoma (MCL), speculating that competition in MCL was the likely driver of its decline. He reported that AUCATZYL's manufacturing turnaround time is tracking well towards the 16-day target, an improvement from the clinical trial. He deemed it premature to provide a specific success rate but noted the strong launch indicates high-quality product delivery.

Asthika Goonewardene of Truist Financial requested color on the time elapsed from site activation to the treatment of the first commercial patient. He also asked about the current sentiment among physicians regarding the potential to avoid a subsequent transplant after AUCATZYL treatment.

Answer

Executive Christian Itin described the time from activation to first patient as 'quite variable,' depending on patient availability, but noted that centers are getting into a 'repeat mode,' which is a positive early sign. Regarding transplants, Itin mentioned that only 18% of trial patients proceeded to transplant and that data showing transplanted patients didn't fare better has 'resonated with a lot of the physicians,' suggesting a growing conviction that AUCATZYL can be a stand-alone therapy.

Asthika Goonewardene asked about Compugen's flexibility to partner COM902, an unpartnered FC-reduced TIGIT antibody, given that the binder was licensed to AstraZeneca for bispecifics, and inquired about any restrictions or financial terms.

Answer

President and CEO Eran Ophir confirmed that Compugen fully owns COM902 and has no restrictions on partnering it, beyond the specific binder license to AstraZeneca for bispecific use. He highlighted the potential for significant interest in COM902 following successful readouts from other FC-reduced TIGIT programs in 2026, allowing Compugen to be opportunistic.

Asthika Goonewardene inquired about COM902's unpartnered status, asking if Compugen retains flexibility to partner it with a separate company and about any restrictions or financial terms.

Answer

Eran Ophir, President and CEO of Compugen, confirmed that Compugen fully owns COM902 and has no restrictions on partnering it, beyond the license to AstraZeneca for its use in bispecifics. He emphasized the company's opportunistic approach, anticipating significant interest and potential deals similar to past FC-active TIGIT agreements following successful readouts in 2026.

Asked for details on COM701's activity in PD-L1 positive patients in light of Merck's B96 trial, and inquired about the potential for combining their TIGIT with a PD-1/VEGF therapy, the rationale for an Fc inactive approach in that context, and if this has been discussed with partners.

Answer

The company responded that COM701 has shown activity in both PD-L1 positive and negative patients, which they attribute to the unique PVRIG biology. Regarding PD-1/VEGF combinations, they see a mechanistic rationale for combining with PVRIG blockade. They believe an Fc inactive TIGIT would be preferable in such a combination to avoid potential additive toxicity, as combining a PD-1/VEGF with a potentially toxic Fc active TIGIT could be challenging.

Asthika Goonewardene of Truist Securities asked about the biomarker strategy for the upcoming Phase 2 study, the rationale for not including TIGIT blockade initially, and whether the company had received any feedback from the FDA on the trial design.

Answer

Chief Scientific Officer Dr. Eran Ophir explained that while an initial signal for the PVRL2 biomarker exists, the data is not yet sufficient for prospective enrichment, so the trial will rely on its design for a response signal while continuing to collect biomarker data. He stated that TIGIT blockade could be a logical next step in the platform study after COM701 monotherapy potentially increases T-cell infiltration. Chief Medical Officer Dr. Michelle Mahler confirmed they have not yet spoken with the FDA but have designed the trial to be robust and align with agency guidance, planning to engage post-data.

Asthika Goonewardene inquired whether Diraxonrasib resistance mechanisms in non-small cell lung cancer (NSCLC) are expected to mirror those in PDAC, if new resistance mechanisms are emerging, and how this influenced the choice of pembrolizumab and chemotherapy for combination. He also asked if the four-month chemotherapy requirement in Resolute 304 helps select borderline resectable patients.

Answer

Steve Kelsey, President of Research and Development, stated that NSCLC resistance data is not yet mature for public disclosure and that resistance mechanisms may differ from PDAC, making direct inference difficult. He explained that pembrolizumab selection is driven by its role as standard of care and evidence that RAS suppression enhances its efficacy. Alan Sandler, Chief Development Officer, clarified that the four-month chemotherapy in Resolute 304 is standard of care, and patients must be completely resected (R0 or R1) to enter, which broadens access for borderline resectable patients if surgery is successful. Mark Goldsmith, Chairman and CEO, added that standardizing chemotherapy duration ensures a uniform patient population.

Asthika Goonewardene asked about expected resistance mechanisms for Diraxonrasib in NSCLC, whether they are similar to PDAC or new, and how this guided the choice of pembrolizumab and chemotherapy combination. He also followed up on whether requiring four months of chemotherapy in Resolute 304 helps select out borderline resectable patients.

Answer

Steve Kelsey, President of Research and Development, stated that NSCLC resistance data is not yet mature enough for public disclosure, noting potential differences from PDAC and CRC. He explained pembrolizumab selection is driven by its standard-of-care inclusion and evidence that RAS suppression enhances its effectiveness. Alan Sandler, Chief Development Officer, clarified that the four months of chemotherapy is standard of care, and patients must be pathologically completely resected (R0 or R1) to enter Resolute 304, which broadens access for borderline resectable patients if surgery is successful.

Asthika Goonewardene asked if Merck's positive LITESPARK-011 results might reduce the likelihood of a pivotal second-line study for Belzutifan and Zanzalintinib in RCC, given potential population overlap. He also asked for the Cabozantinib clinical trial contribution in Q3.

Answer

Chris Senner, Chief Financial Officer, confirmed there were no clinical trial sales for Cabozantinib in Q3. Dana Aftab, Executive Vice President of Research and Development, expressed confidence that the Merck collaboration trials for Zanza would continue as planned and start later this year, declining to speculate on other companies' data.

Asthika Goonewardene asked about the potential impact of Merck's positive LITESPARK-011 results on the planned pivotal second-line study of Belzutifan plus Zanzalintinib, and the clinical trial contribution for Cabozantinib in Q3.

Answer

Dana Aftab, EVP of Research and Development, expressed confidence that the Merck collaboration trials for Belzutifan and Zanzalintinib would continue as planned, starting later this year, without speculating on other companies' data. Chris Senner, CFO, confirmed there were no clinical trial sales for Cabozantinib in Q3 2025.

Asthika Goonewardene from Truist Securities sought clarification on whether the STELLAR-303 data is 'clinically meaningful' given the press release's conservative tone, and asked about plans to move zanzalutinib into earlier lines of CRC therapy.

Answer

EVP & CMO Amy Peterson stated the conservative language was purposeful due to a dynamic regulatory environment, but was clear that a statistically significant OS benefit is unequivocal. She confirmed strong interest in developing zanzalutinib as a monotherapy in the adjuvant CRC setting for high-risk patients to potentially prevent disease recurrence.

Asthika Goonewardene asked about the potential for a sales bolus from the NET launch and when a stable run-rate might be established. He also questioned if the statistical analysis change for the STELLAR-303 trial was intended to improve the probability of success.

Answer

EVP of Commercial P.J. Haley stated that a significant patient bolus is not expected for the NET launch. Chief Medical Officer Amy Peterson explained the STELLAR-303 modification to dual primary endpoints was driven by data maturity, allowing for a simultaneous analysis of the ITT population, which could benefit a larger patient group, rather than being a move to alter statistical hurdles.

Asthika Goonewardene asked for clarification on the 'misguided notion' of zanzalintinib (zanza) being similar to cabozantinib (cabo), questioning the overlap in indications and the risk of forced generic substitution by payers.

Answer

President and CEO Michael Morrissey dismissed direct comparisons, emphasizing that Exelixis is focused on running large, global, randomized pivotal trials for zanzalintinib against contemporary standards of care. He stated that positive data from these trials, not speculative comparisons of small datasets, will be the ultimate driver for label-enabling efforts and commercial success.

Asthika Goonewardene inquired about the diligence process for the Merck collaboration on zanzalintinib, asking for insight into why Merck would partner on the asset given its existing relationship with lenvatinib.

Answer

President and CEO Michael Morrissey stated that while he could not speak for Merck, the extensive diligence process took place over many months. He emphasized the value of partnering with a leader like Merck, which validates zanzalintinib and brings significant expertise in executing large pivotal trials.

Asthika Goonewardene asked if Summit Therapeutics needs to take a new data cut for overall survival (OS) for the HARMONi filing with the FDA, or if they are filing with the data they currently have. He also questioned the rationale for expanding the HARMONi-3 squamous cohort recruitment to 600 patients from the original 400-450, especially after the strong HARMONi-6 data.

Answer

Dave Gancarz, Chief Business and Strategy Officer, stated that Summit Therapeutics has not publicly discussed specific details of working with the FDA regarding a new OS data cut, but they are currently working on the application based on the World Lung data. Urte Gayko, Chief Regulatory Quality and Safety Officer, explained that the increased sample size for the HARMONi-3 squamous cohort is necessary to sufficiently power both the PFS and OS endpoints, given the decision to split the cohorts into two separate analyses.

Asthika Goonewardene from Truist Securities asked about the HARMONi-3 trial's statistical analysis plan, whether it would assess the combined population or use a stepwise approach. He also inquired about FDA discussions regarding a potential accelerated filing and the scientific rationale for the Pfizer collaboration.

Answer

Dr. Allen Yang, Chief Medical Officer, stated the plan is to conduct a primary analysis on the combined patient population to accelerate market access. He confirmed FDA discussions have occurred but could not disclose details. An executive explained the Pfizer deal rationale is partly empiric, combining two active drugs, with the potential for synergistic immune system effects that they are eager to explore.

Asthika Goonewardene of Truist Securities asked if the rationale for using an anti-CD52 antibody, based on early Cellectis data in refractory settings, still applies to the different dynamics of the first-line consolidation setting. He also inquired if upcoming data would detail the patient mix.

Answer

CEO Dr. David Chang agreed the historical context was correct for refractory disease but stressed that the minimal disease MRD-positive setting is fundamentally different, which was a core hypothesis behind the trial's original three-arm design. He noted they would aim to provide informative data on patient mix, but the futility analysis is based on a small cohort of 24 patients.

Representing Asthika Goonewardene, Karina Rabayeva asked if the ALLO-316 program in renal cell carcinoma has been deprioritized given the focus on other assets.

Answer

CEO David Chang acknowledged that the company must prioritize its programs. He pointed to the upcoming oral presentation of ALLO-316 data at ASCO and stated that further guidance on the program's path forward would be provided after the presentation.

Asthika Goonewardene of Truist Securities asked how much follow-up is needed to validate a lymphodepletion-free strategy for ALLO-329 and sought to confirm if the durable responders in the JCO paper were the same patients with low disease burden.

Answer

Dr. David Chang, President and CEO, agreed that longer-term follow-up will be needed to assess clinical outcomes. Dr. Zachary Roberts, EVP of R&D and CMO, clarified that while low disease burden strongly correlated with achieving a complete remission, the cema-cel product is potent, and patients with bulky disease also achieved durable CRs, indicating a mix of profiles among long-term responders.

Asthika Goonewardene of Truist Securities asked if the upcoming data would definitively answer whether the Dose B mitigation strategy allows patients to stay on therapy longer, what proportion of TNBC patients have been exposed to Enhertu, and whether the pivotal study would be exclusive to TNBC or broader.

Answer

President and CEO Dr. Martin Huber expressed confidence that the second-half data will be sufficient to answer the question on treatment interruptions. He recalled that prior data showed about 27% of patients had received both Trodelvy and Enhertu. For the pivotal study, he stated that while the current focus is on TNBC due to capital constraints, the company's Fast Track designation for 'post-topo breast cancer' is broader and could encompass HER2-low patients, making a wider population a possibility.

Asthika Goonewardene asked for clarity on the timing of data from the Emi-Le expansion cohort and whether Mersana is exploring dosing intervals beyond the three previously disclosed.

Answer

CEO Dr. Martin Huber stated that the company is not providing further details on the timing of the expansion cohort data but confirmed enrollment is ongoing with enthusiastic investigators. He also confirmed that no new dosing schedules are being studied beyond the three that have already been shared.

Asthika Goonewardene from Truist Securities questioned the potential regulatory risks, asking about confidence in filing for accelerated approval for RINA S and the possibility of FDA pushback on Epkinley's FL1 data.

Answer

Chief Development Officer Judith Klimovsky expressed confidence in the regulatory path for both assets. She stated there is no reason to expect pushback on RINA S with strong data and sees a clear path forward for Epkinley, citing its Breakthrough Therapy Designation and the FDA's acceptance of the SBLA.

Asthika Goonewardene from Truist Securities inquired about regulatory risk, asking about Genmab's confidence in filing the single-arm RAINFALL-one Part C for accelerated approval and the potential for FDA pushback on the Epcor FL-1 filing to await more mature overall survival data.

Answer

Judith Klimovsky, EVP & Chief Development Officer, stated that for RINA S (RAINFOL), accelerated approval is contingent on strong data, and the company perceives no undue risk, reinforcing the 2027 launch commitment. Regarding Epcor FL-1, she expressed high confidence, citing its Breakthrough Therapy Designation and the FDA's acceptance of the sBLA with a set PDUFA date.

Asthika Goonewardene of Truist asked about the status of Rina-S in tumor types beyond ovarian and endometrial, and for thoughts on a competitor's upcoming ODAC meeting for a similar drug class.

Answer

CMO Tahamtan Ahmadi clarified that a non-small cell lung cancer cohort for Rina-S is actively enrolling and that they are not deprioritizing other tumors. He declined to speculate on the competitor's ODAC but expressed confidence in EPKINLY's own data and development path. CDO Judith Klimovsky added that EPKINLY's recent NCCN endorsement is very encouraging.

Asthika Goonewardene of Truist Securities inquired about EPKINLY's commercial performance, asking for the sales mix between academic and community centers and if there was any pushback on admission requirements. He also asked for an update on the EPKINLY outpatient study and whether the GEN1046 pivotal trial would use different doses based on PD-L1 expression levels.

Answer

Chief Operating Officer Anthony Mancini explained that the EPKINLY launch was initially focused on academic centers but is now seeing a modest shift to community practices, which is still in its early stages. Chief Medical Officer Tahamtan Ahmadi added that the outpatient study is progressing well, with data expected by year-end. He definitively stated that the GEN1046 trial will use a single dose and schedule, regardless of PD-L1 status.

Karina Rabayeva, on behalf of Asthika Goonewardene of Truist Securities, asked about the manufacturing volume split between the internal iCTC and the contract manufacturer, and whether a larger amount of tumor tissue is needed to improve success rates.

Answer

An executive stated the internal iCTC handles the majority of manufacturing volume. EVP of Medical Affairs Dr. Brian Gastman explained that while guidance asks for a reasonable amount of tumor, the focus is on best practices for handling and preparation, not just volume, to accommodate surgeons with varying experience levels.

Asthika Goonewardene asked what proportion of the 70 active Authorized Treatment Centers (ATCs) have reached a 'steady state' of operation.

Answer

Interim CEO Frederick Vogt estimated that a very low number, likely 10% or less, have reached steady state. Chief Commercial Officer Dan Kirby added that even the most active centers (those with 10+ infusions) are not considered saturated, as the strategy is to drive more community referrals to these experienced sites.

Asthika Goonewardene of Truist Securities asked for more detail on the improving out-of-spec rate, questioning if it's driven by experienced centers improving or new centers performing better from the start.

Answer

Interim CEO Frederick Vogt explained that it is a combination of both factors. Early learnings from helping struggling centers improve are now being applied to train new ATCs, enabling them to avoid common mistakes. The company uses performance scorecards and a peer-to-peer support team to build momentum across the entire network.

Karina, on behalf of Asthika Goonewardene, asked about the notable rate of stomatitis seen in the AACR data for the BNT327 and BNT325 combination, inquiring how this toxicity will be managed.

Answer

CEO Ugur Sahin clarified that the rate of stomatitis in the combination was very comparable to that observed with the BNT325 ADC as a monotherapy. He found this encouraging as it suggested no additional or additive toxicity from combining the two agents.

Asthika Goonewardene of Truist Securities asked for details on the Phase II/III trial design for BNT327 in NSCLC, including cohort sizes and the rationale for the statistical analysis plan.

Answer

CMO Özlem Türeci and CEO Ugur Sahin clarified the trial design. The Phase II dose-justification portion involves ~40 patients, while the Phase III component will enroll over 940 patients. Sahin explained that, following FDA discussions, they are treating squamous and non-squamous histologies as two separate indications in the analysis due to recent data showing different outcomes for some therapies in these populations.

Asthika Goonewardene of Truist Securities questioned what the right comparator would be for a future pivotal trial of casdatifan plus volrustomig in RCC and asked about the importance of matching or exceeding the durable complete response rate seen with ipilimumab-nivolumab.

Answer

CMO Dimitry Nuyten identified the CheckMate-214 study (ipi-nivo) as the relevant benchmark, noting the combination's key advantage could be reducing the high primary progression rate seen with ipi-nivo. COO Jennifer Jarrett added that this potential to improve the front-end of the PFS curve is what attracted AstraZeneca to the collaboration.

Asthika Goonewardene from Truist Securities asked about the readout timing for a second cohort in the etrumadenant colorectal cancer study and inquired about the rationale for combining HIF-2 alpha inhibitors with checkpoint inhibitors.

Answer

CEO Terry Rosen explained that the readout for the second etrumadenant cohort is expected sometime in 2025, as the data is not yet mature. Regarding combinations, he affirmed that pairing a HIF-2 alpha inhibitor with anti-PD-1 or anti-CTLA4 is a logical strategy and mentioned that a second registrational trial for casdatifan in the frontline setting will be announced soon.

Asthika Goonewardene of Truist Securities asked for details on the IGM-8444 caspase-3 biomarker data, including measurement timing and patient distribution, and pressed for more specific timing on future data releases.

Answer

Chief Medical Officer Dr. Chris Takimoto clarified that the caspase-3 data represents the maximum change observed, which occurs quickly after treatment, and noted the 10 mg/kg cohort was mostly monotherapy patients while the 3 mg/kg cohort was mostly FOLFIRI combination patients. CEO Fred Schwarzer reiterated that while a data release for the single-arm cohorts in 2023 is a "reasonable hope," no firm decision has been made.

Asthika Goonewardene questioned if the interferon-gamma dominant cytokine profile of IGM-2323 holds up with repeat dosing, asked about the time elapsed since the prior CAR-T treatment for the patient who experienced CRS, and inquired about the dissociation kinetics of IGM-2323 from tumor cells.

Answer

Chief Medical Officer Daniel Chen confirmed that the repeatable interferon-gamma dominant T-cell activation remains a primary hypothesis and a key factor they are looking to optimize for the recommended Phase II dose. He noted the prior CAR-T treatment was not recent. Chief Scientific Officer Bruce Keyt added that the dissociation rate of IGM-2323 from the tumor target is effectively irreversible, leading to very durable effects, a finding consistent with clinical observations.

Asthika Goonewardene inquired about the success criteria for the upcoming HB-200 data, specifically asking about the bar for duration of response (DOR) and progression-free survival (PFS), and also asked about potential future components to add to the HB-200/PD-1 combination therapy.

Answer

Chief Medical Officer Katia Schlienger explained that while they will report on various efficacy endpoints, the duration of response data will likely be immature at the Q2 update and requires more follow-up. CEO Joern Aldag added that while PFS is short for the standard of care, their data will allow for a comparison. Regarding future combinations, Mr. Aldag pointed to the upcoming AACR data with IL-2 as an example of how they are exploring ways to enhance therapeutic effects.

Asthika Goonewardene of Truist Securities asked for more detail on the AACR presentation, specifically the number of patients with translational data, the type of analysis to be used for T-cell response, and whether any biopsy or T-cell fitness data would be included.

Answer

Igor Matushansky, Chief Medical Officer, stated the AACR data will include a single-digit number of patients, primarily from the HB-201 arm. The analysis will be a direct Elispot assay, with percentage-based data likely coming closer to ASCO. He clarified that biopsy and T-cell fitness data are planned for presentation at the SITC conference, not AACR.