Q4 2025 Summit Therapeutics Inc Earnings Call

February 23, 2026

Speaker #1: Good afternoon and welcome to Summit Therapeutics' Q4 and year-end 2025 earnings call. All participants will be in listen-only mode until the question-and-answer session portion of this call.

Speaker #1: We do not expect any technical difficulties today. However, in the event that we lose the webcast connection and are unable to provide any updates, please wait up to 10 minutes for resolution.

Operator: We do not expect any technical difficulties today. However, in the event that we lose the webcast connection and are unable to provide any updates, please wait up to 10 minutes for resolution. Please refer to the company's website for updates. Please note that today's call is being recorded. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press the star key followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. At this time, I would like to turn the call over to Dave Gancarz, at Summit Therapeutics, Chief Business and Strategy Officer. You may proceed.

Speaker #1: Please refer to the company's website for updates. Please note that today's call is being recorded. After the speaker's remarks, there will be a question-and-answer session.

Speaker #1: If you would like to ask a question during this time, simply press the star key followed by the number 1 on your telephone keypad.

Speaker #1: If you would like to withdraw your question, press star 1 again. At this time, I would like to turn the call over to Dave Gancarz at Summit Therapeutics, Chief Business and Strategy Officer.

Speaker #1: You may proceed.

Speaker #2: Good afternoon, and thank you for joining us. On today's call, we will provide an update on our fourth quarter and year-end 2025 financial results and operational progress.

Dave Gancarz: Good afternoon, thank you for joining us. On today's call, we will provide an update on our Q4 and year-end 2025 financial results and operational progress. This afternoon's press release is available on our website, www.smmttx.com. Our Form 10-K was also filed today and is available on our website and via the SEC's website. Today's call is being simultaneously webcast, and an archived replay will also be made available later today on our website. Joining me on the call today is Robert Duggan, our Chairman of the Board and Co-Chief Executive Officer, Dr. Maky Zangeneh, our President and Co-Chief Executive Officer, Manmeet Soni, our Chief Operating Officer and Chief Financial Officer, and Dr. Allen Yang, Chief of R&D Strategy. I'm Dave Gancarz, the Chief Business and Strategy Officer at Summit.

Speaker #2: This afternoon's press release is available on our website, www.smmtx.com. Our Form 10-K was also filed today and is available on our website and via the SEC's website.

Speaker #2: Today's call is being simultaneously webcast, and an archived replay will also be made available later today on our website. Joining me on the call today is Bob Duggan, our Chairman of the Board and Co-Chief Executive Officer.

Speaker #2: Dr. Matthew Zanganeh, our President and Co-Chief Executive Officer; Manmeet Soni, our Chief Operating Officer and Chief Financial Officer; and Dr. Alan Yang, Chief of R&D Strategy.

Speaker #2: I'm Dave Gancarz, the Chief Business and Strategy Officer at Summit. Before we get started with the rest of the call, I would like to note that some statements made by our management team, and some responses to questions that we make today, may be considered forward-looking statements based on our current expectations.

Dave Gancarz: Before we get started with the rest of the call, I would like to note that some statements made by our management team and some responses to questions that we make today may be considered forward-looking statements based on our current expectations. Summit cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Please refer to our SEC filings for information, including the Form 10-K issued today, about these risks and uncertainties. Summit undertakes no obligation to update these forward-looking statements except as required by law. One item to note, this presentation is being webcast with slides, so we'll be referring to the slides being displayed in the webcast link. I'd encourage you to use the webcast link to see the slides being presented this afternoon that will accompany our comments.

Speaker #2: Summit cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements.

Speaker #2: Please refer to our SEC filings for information. Including the Form 10-K issued today, about these risks and uncertainties. Summit undertakes no obligation to update these forward-looking statements except as required by law.

Speaker #2: One item to note: this presentation is being webcast with slides, so we'll be referring to the slides being displayed in the webcast link. I'd encourage you to use the webcast link to see the slides being presented this afternoon that will accompany our comments.

Speaker #2: Following comments from our team, we will take questions. And with that, I'd like to hand it over to Mecky.

Dave Gancarz: Following comments from our team, we will take questions. With that, I'd like to hand it over to Maky.

Speaker #1: Thank you, Dave. Good afternoon, everyone, and thank you for joining us today. I'm very proud of Team Summit's ongoing accomplishments and their growing, positive data sets and support around Ibanesimab, a PD-1/VEGF bispecific and our lead investigational asset.

Maky Zangeneh: Thank you, Dave. Good afternoon, everyone, and thank you for joining us today. I'm very proud of Team Summit's ongoing accomplishments and the growing positive data sets and support around ivonescimab, a PD-1/VEGF bispecific, our lead investigational asset. We are a highly focused, mission-driven, patient-first company with a mission to make a significant difference in improving the lives of patients suffering from cancer. Our team is growing rapidly as we expand our clinical development plan and prepare for commercialization in anticipation of a decision from the FDA on our BLA near the end of this year. We have announced a few significant events today, starting with the update related to our HARMONi-3 study.

Speaker #1: We are a highly focused, mission-driven, patient-first company with a mission to make a significant difference in improving the lives of patients suffering from cancer. Our team is growing rapidly as we expand our clinical development plan and prepare for commercialization in anticipation of a decision from the FDA on our BLA near the end of this year.

Speaker #1: We have announced a few significant events today. Starting with the updates related to our HarmonyTree study. Last quarter, we announced our HarmonyTree Phase III trial evaluating Ibanesimab plus chemo as a first-line treatment for patients with squamous and non-squamous non-small cell lung cancer was amended to have separate analysis by squamous and non-squamous histologies for the primary endpoints of PFS and OS for each cohort.

Maky Zangeneh: Last quarter, we announced our HARMONi-3 Phase 3 trial, evaluating ivonescimab plus chemo as first-line treatment for patients with squamous and non-squamous non-small cell lung cancer, was amended to have separate analysis by squamous and non-squamous histologies for primary endpoints of PFS and OS for each cohort. The squamous cohort was planned to complete enrollment in the first half of 2026, followed by the non-squamous cohort in the second half of this year. As announced today, we have now completed screening patients for the squamous cohort of the HARMONi-3 study, and the last patient will be randomized in the next couple of weeks. We have amended our statistical plan to now include an interim PFS analysis for our squamous cohort, and we are planning to conduct the interim PFS analysis during Q2 2026.

Speaker #1: The squamous cohort was planned to complete enrollment in the first half of 2026, followed by the non-squamous cohort in the second half of this year.

Speaker #1: As announced today, we have now completed screening patients for the squamous cohort of the HarmonyTree study and the last patient will be randomized in the next couple of weeks.

Speaker #1: We have amended our statistical plan to now include an interim PFS analysis for our squamous cohort, and we are planning to conduct the interim PFS analysis during the second quarter of 2026.

Speaker #1: Overall survival will be immature at the time of this analysis; therefore, we may not have overall survival results to communicate at that time. As you recall, we initially included PFS as a primary endpoint in this study and opened the readout of HarmonyTree comparing Ibanesimab to Pembrol in PD-L positive frontline lung cancer patients.

Maky Zangeneh: Overall survival will be immature at the time of this analysis. Therefore, we may not have overall survival results to communicate at that time. As you recall, we initially included PFS as a primary endpoint in this study upon the readout of HARMONi-2, comparing ivonescimab to pembro in PD-L1 positive frontline lung cancer patients, which showed a highly statistical significant and clinically meaningful benefit in PFS, with a hazard ratio of 0.51 and a median improvement in PFS of over 5 months. This point was later validated with HARMONi-6, showing that there was a substantial PFS benefit when comparing ivonescimab plus chemo versus a PD-1 inhibitor plus chemo, with a hazard ratio of 0.60. Two Phase 3 studies conducted by Akeso in China in frontline non-small cell lung cancer demonstrated a 40% plus improvement in PFS for the ivonescimab arm.

Speaker #1: Which showed a highly statistical significance and clinically meaningful benefit in PFS with a hazard ratio of 0.51 and a median improvement in PFS of over five months.

Speaker #1: This point was later validated with Harmony6, showing that there was a substantial PFS benefit when comparing Ibanesimab plus chemo versus a PD-1 inhibitor plus chemo, with a hazard ratio of 0.60.

Speaker #1: Two Phase III studies conducted by Equeso in China in frontline non-small cell lung cancer demonstrated a 40% plus improvement in PFS for Ibanesimab. Both the HarmonyTree and Harmony6 PFS results were based on the planned interim PFS analysis of each study.

Maky Zangeneh: Both the HARMONi-2 and HARMONi-6 PFS results were based on the planned interim PFS analysis of each study. By adding an interim PFS analysis, we open the door to an earlier discussion with the health authorities for our multi-regional phase 3 studies. The final PFS analysis, if applicable, and an interim analysis for OS, is planned to be conducted in the second half of this year, consistent with previous guidance. For the non-squamous cohort of HARMONi-3, we continue to expect enrollment to complete in the second half of this year, and to reach the pre-specified number of events for the final PFS analysis by the first half of 2027.

Speaker #1: By adding an interim PFS analysis, we opened the door to an earlier discussion with the health authorities for our multi-regional Phase III study. The final PFS analysis, if applicable, and an interim analysis for OS are planned to be conducted in the second half of this year, consistent with previous guidance.

Speaker #1: For the non-squamous cohort of HarmonyTree, we continue to expect enrollment to complete in the second half of this year and to reach the pre-specified number of events for the final PFS analysis by the first half of 2027.

Speaker #1: There are several meaningful moments upcoming related to these two cohorts, each of which are independent from each other, like two separate studies in one protocol. 2026 will be pivotal to providing additional clarity to expand the reach of IVO to a broader population of lung cancer patients.

Maky Zangeneh: There are several meaningful moments upcoming related to these two cohorts, each of which are independent from each other, like two separate studies in one protocol, where 2026 will be pivotal to providing additional clarity to expand the reach of ivo to a broader population of lung cancer patients. Additionally, we announced today the first update to the ivo phase 3 clinical trial program, which will continue to expand throughout 2026. ILLUMINE, a new phase 3 study in PD-L1 positive frontline head and neck squamous cell carcinoma, will be sponsored by GORTEC, a French cooperative group dedicated to head and neck oncology, with initial enrollment expected to begin early next quarter. The study intends to evaluate both ivonescimab monotherapy and in combination with ligofilimab, Akeso's proprietary anti-CD47 monoclonal antibody against monotherapy pembro in this 3-arm randomized study.

Speaker #1: Additionally, we announced today the first update to the IVO Phase III clinical trial program, which will continue to expand throughout 2026. Illumin, a new Phase III study in PD-L1 positive frontline head and neck squamous cell carcinoma, will be sponsored by GORTECH, a French cooperative group dedicated to head and neck oncology, with initial enrollment expected to begin early next quarter.

Speaker #1: The study intends to evaluate both Ibanesimab monotherapy and, in combination with Legofilimab, Equeso preparatory anti-CD47 monoclonal antibody, against monotherapy Pembrol in these three-arm randomized studies.

Speaker #1: Approximately 780 patients are intended to be enrolled across the three arms in multiple countries in Europe and in China. We may consider potentially expanding the study to include US sites as well.

Maky Zangeneh: Approximately 780 patients are intended to be enrolled across the three arms in multiple countries in Europe and in China. We may consider potentially expanding the study to include US sites as well. Phase 2 data supporting the potential use of ivonescimab in this patient population was previously presented at ESMO 2024, where ivonescimab, in combination with ligofilimab, demonstrated an objective response rate of 60% in 20 patients, with median PFS of 7.1 months, after median follow-up of 4.1 months. At the time of this analysis, no patients receiving ivonescimab plus ligofilimab discontinued treatment due to the treatment-related adverse events. The data generated in phase 2 is encouraging in light of existing standard of care. Akeso is also running a single agent phase 3 trial in this population in China.

Speaker #1: Phase II data supporting the potential use of Ibanesimab in these patient populations was previously presented at ESMO 2024, where Ibanesimab in combination with legofilimab demonstrated an objective response rate of 60% in 20 patients, with a median PFS of 7.1 months after a median follow-up of 4.1 months.

Speaker #1: At the time, of this analysis, no patients receiving Ibanesimab plus legofilimab discontinued treatment due to the treatment-related adverse events. The data generated in Phase II is encouraging in light of existing standards of care and Equeso is also running a single-region Phase III trial in these populations in China.

Speaker #1: Turning to our clinical collaboration with Revolution Medicine, today we announced the first patient has been dosed in the collaboration's initial clinical trial. As a reminder, Ibanesimab is being evaluated in combination with three RAS-on inhibitors.

Maky Zangeneh: Turning to our clinical collaboration with Revolution Medicines, today we announced the first patient has been dosed in the collaboration's initial clinical trial. As a reminder, ivonescimab is being evaluated in combination with three RAS(ON) inhibitors, including daraxonrasib, a multi-selective RAS inhibitor, zoldonrasib, a KRAS G12D selective inhibitor, and eleronrasib, a KRAS G12C selective inhibitor, across multiple solid tumor settings with RAS mutations, including pancreatic cancer, colorectal cancer, and non-small cell lung cancer. Finally, as we announced last month, we entered into a clinical collaboration with GSK to evaluate ivonescimab in combination with GSK's novel B7-H3 antibody-drug conjugate in multiple solid tumors. The initial study under this collaboration is expected to begin dosing patients in mid-2026. Let's now take a step back and look at ivonescimab accomplishments to date. There are many to list. We are just highlighting some of them.

Speaker #1: Including Daraksan-Rasip, a multi-selective RAS inhibitor; Zoledan-Rasip, a KRAS G12D-selective inhibitor; and Eliron-Rasip, a KRAS G12C-selective inhibitor, across multiple solid tumor settings with RAS mutations, including pancreatic cancer, colorectal cancer, and non-small cell lung cancer.

Speaker #1: Finally, as we announced last month, we entered into a clinical collaboration with GSK to evaluate Ibanesimab in combination with GSK's novel B7-H3 antibody-drug conjugate in multiple solid tumors.

Speaker #1: The initial study under this collaboration is expected to begin dosing patients in mid-2026. Let's now take a step back and look at Ibanesimab accomplishments to date.

Speaker #1: There are many to list. We are just highlighting some of them. Ibanesimab has readout four Phase III clinical studies to date all four of which have had positive data leading to two approvals in China so far.

Maky Zangeneh: ivonescimab has read out 4 phase 3 clinical studies to date, all 4 of which have had positive data, leading to 2 approvals in China so far. At this time, a total of 15 phase 3 trials have been announced, currently ongoing, or have read out in multiple tumor types. 44 clinical trials have been initiated since 2019 between Summit and Akeso, evaluating ivonescimab in a variety of solid tumors. When considering investigator-initiated and collaborative studies, a total of 142 clinical trials are now listed on ClinicalTrials.gov. The enthusiasm demonstrated by investigators around the world to generate data and seek positive signals for patients facing high unmet medical needs, really speaks to the opportunity and optimism surrounding ivonescimab. Together with our partner, Akeso, we have enrolled over 4,000 patients in either Summit-sponsored or Akeso-sponsored clinical trials across the world.

Speaker #1: At this time, a total of 15 Phase III trials have been announced, are currently ongoing, or have readouts in multiple tumor types. Forty-four clinical trials have been initiated since 2019 between Summit and Equeso, evaluating Ibanesimab in a variety of solid tumors.

Speaker #1: When considering investigator-initiated and collaborative studies, a total of 142 clinical trials are now listed on clinicaltrials.gov. The enthusiasts demonstrated by investigators, around the world, to generate data and seek positive signals for patients facing high unmet medical needs really speaks to the opportunity and optimism surrounding Ibanesimab.

Speaker #1: Together with our partner Equeso, we have enrolled over 4,000 patients in either Summit-sponsored or Equeso-sponsored clinical trials across the world. Commercially in China, over 60,000 patients have received Ibanesimab based on two approved indications by the NMPA in non-small cell lung cancer, according to our partners at Equeso.

Maky Zangeneh: Commercially, in China, over 60,000 patients have received ivonescimab based on two approved indications by the NMPA in non-small cell lung cancer, according to our partners at Akeso. A third indication, based on the positive HARMONi-6 study in frontline squamous non-small cell lung cancer, is currently under review by the NMPA in China. I wanted to make sure this point is not missed. Four phase 3 trials evaluating ivonescimab have read out to date. All four with positive data read out. This represents the only phase 3 readout that we have seen in the PD-1/VEGF bispecific class today. These positive trials are supported by the differentiated mechanism of action of ivonescimab. Here is the current ivonescimab development plan across Summit and Akeso.

Speaker #1: A third indication, based on the positive HarmonySIX study in frontal and squamous non-small cell lung cancer, is currently under review by the NMPA in China.

Speaker #1: I wanted to make sure this point is not missed. Four Phase III trials evaluating Ibanesimab have readout to date and all four with positive data readouts.

Speaker #1: This represents the only Phase III readout that we have seen in the PD-1/VEGF bispecific class to date. These positive trials are supported by the differentiated mechanism of action of Ibanesimab.

Speaker #1: Here is the current Ibanesimab development plan across Summit and Equeso. In total, there are 15 randomized Phase III trials: four of which are global Summit-sponsored studies in non-small cell lung cancer and colorectal cancer; one of which is a multi-regional cooperative group study announced today; and 10 of which are being enrolled by Equeso in China in a variety of solid tumor types, including lung, breast, head and neck, BTC, pancreatic, and colorectal cancers.

Maky Zangeneh: In total, there are 15 randomized Phase 3 trials, 4 of which are global Summit-sponsored studies in non-small cell lung cancer and colorectal cancer. One of which is a multi-regional, regional cooperative group study announced today, and 10 of which are being enrolled by Akeso in China in a variety of solid tumor types, including lung, breast, head and neck, BTC, pancreatic, and colorectal cancers. Additionally, Akeso is also currently enrolling multiple Phase 2 trials evaluating ivonescimab in other tumor types: ovarian, gastric, HCC, and others, including non-metastatic settings. Through our partnership with Akeso, we continuously compile a substantial amount of data, allowing us to make faster, more informed decisions, fueling the rapid expansion of our global development plan. Focusing on our pipeline at Summit, we have 4 global Phase 3 trials completed or ongoing.

Speaker #1: Additionally, Equeso is also currently enrolling multiple Phase II trials evaluating Ibanesimab in other tumor types—ovarian, gastric, HCC, and others—including non-metastatic settings. Through our partnership with Equeso, we continuously compile a substantial amount of data, allowing us to make faster, more informed decisions, fueling the rapid expansion of our global development plan.

Speaker #1: Focusing on our pipeline at Summit, we have four global Phase III trials completed or ongoing. Harmony, which read out positively last year; Harmony III, Harmony VII, and Harmony GI III—all three of which are currently enrolling and progressing nicely.

Maky Zangeneh: HARMONi, which read out positively last year, HARMONi-3, HARMONi-7, HARMONi-GI3, all three of which are currently enrolling and progressing nicely. The HARMONi trial evaluated ivonescimab plus chemo against chemo alone as treatment for EGFR mutant non-small cell lung cancer after TKI therapy, a population of significant unmet need with few available treatment options. We submitted a BLA filing last quarter, seeking approval in this proposed indication. In January, we announced the US FDA's acceptance of the filing and a PDUFA target action date of 14 November 2026. As previously disclosed, the FDA noted that a statistically significant overall survival benefit is necessary to support marketing authorization in this setting.

Speaker #1: The Harmony trial evaluated Ibanesimab plus chemo against chemo alone as treatment for EGFR mutant non-small cell lung cancer after TKI therapy a population of significant unmet need with few available treatment options.

Speaker #1: We submitted a BLA filing last quarter seeking approval in this proposed indication and in January we announced the US FDA's acceptance of the filing and a PDUFA target action date of November 14, 2026.

Speaker #1: As previously disclosed, the FDA noted that a statistically significant overall survival benefit is necessary to support marketing authorization in this setting. Considering the safety and efficacy profile of the current FDA-approved options available to patients in this setting, the positive, regionally consistent results of this Phase III multi-regional study, as well as discussions with key opinion leaders and physicians who have administered Ibanesimab to patients, we believe that Ibanesimab is a potential treatment option with a favorable benefit-risk profile.

Maky Zangeneh: Considering safety and efficacy profile of the current FDA-approved options to patients in this setting, the positive, regionally consistent results of this phase 3 multi-regional study, as well as discussions with key opinion leaders and physicians who have administered ivonescimab to patients, we believe that ivonescimab is a potential treatment option with a favorable benefit-to-risk profile. In anticipation of potential approval in Q4 of this year, we continue to ramp up commercial capabilities in preparation for potential launch. HARMONi-3 is evaluating ivonescimab plus chemo against pembro plus chemo in frontline metastatic non-small cell lung cancer. This patient population represent a significant unmet medical need, with nearly 100,000 patients in the United States alone, as this trial covers frontline non-small cell lung cancer patients without genomic mutations, irrespective of histology or PD-L1 status. I spoke a minute ago about the recent changes to this pivotal study.

Speaker #1: In anticipation of potential approval in Q4 of this year, we continue to ramp up commercial capabilities in preparation for potential launch. Harmony III is evaluating Ibanesimab plus chemo against pembrol plus chemo in frontline metastatic non-small cell lung cancer.

Speaker #1: This patient population represents a significant unmet medical need, with nearly 100,000 patients in the United States alone, as this trial covers frontline non-small cell lung cancer patients without genomic mutations, irrespective of histology or PD-L1 status.

Speaker #1: I spoke a minute ago about the recent changes to this pivotal study. For Harmony VII, this study is evaluating Ibanesimab monotherapy against pembrolizumab monotherapy as frontline treatment for patients with non-small cell lung cancer that have high PD-L1 expression levels.

Maky Zangeneh: For HARMONi-7, the study is evaluating ivonescimab monotherapy against pembro monotherapy as frontline treatment for patients with non-small cell lung cancer that have high PD-L1 expression levels. HARMONi-7 continues to enroll well, and we look forward to providing additional updates in the future. Finally, last quarter, we initiated and began enrolling patients in HARMONi-GI3, evaluating ivonescimab plus chemo compared to bev plus chemo in first-line therapy in patients with unresectable colorectal cancer. Our decision to expand into colorectal cancer was driven by encouraging Phase II data published at ESMO 2024, and subsequent continuing enrollment in this Phase II study to China and the United States with additional chemotherapy regimens. This data set allowed us to make an informed decision to move forward in CRC, specifically with the FOLFIRINOX chemo combination.

Speaker #1: Harmony VII continues to enroll well and we look forward to providing additional updates in the future. And finally, last quarter, we initiated and began enrolling patients in Harmony GI III evaluating Ibanesimab plus chemo compared to BEV plus chemo in first-line therapy in patients with unresectable colorectal cancer.

Speaker #1: Our decision to expand into colorectal cancer was driven by encouraging Phase II data published at ESMO 2024 and subsequent continuing enrollment in this Phase II study in China and the United States with an additional chemotherapy regimen.

Speaker #1: This data set allowed us to make an informed decision to move forward in CRC, specifically with the FOLFOX chemo combination. We look forward to providing further updates on the Phase II data set later this year, as well as the Harmony GI III study as the trial progresses.

Maky Zangeneh: We look forward to providing further updates on the phase II data set later this year, as well as the HARMONi-GI3 study as the trial progresses. Looking beyond our own sponsored trials, we are expanding into additional settings with multiple collaborations and other groups. We have the phase III ILLUMINE study, sponsored by GORTEC, evaluating ivonescimab in head and neck cancer that I spoke to earlier. With respect to novel combination, we announced that the first patient was dosed this quarter in our collaboration with Revolution Medicines to evaluate ivonescimab in combination with 3 novel RAS inhibitors across multiple solid tumor settings. We are excited to learn about the opportunity and potential to improve patient outcomes with ivonescimab combined with these novel targeted therapies and promising molecule.

Speaker #1: Looking beyond our own sponsored trials, we are expanding into additional settings with multiple collaborations and other groups. We have the Phase III ILLUMIN study sponsored by GORTEC evaluating Ibanesimab in head and neck cancer that I spoke to earlier.

Speaker #1: With respect to novel-novel combination, we announced that the first patient was those this quarter in our collaboration with Revolution Medicine to evaluate Ibanesimab in combination with three novel RAS inhibitors across multiple solid tumor settings.

Speaker #1: We are excited to learn about the opportunity and potential to improve patient outcomes with Ibanesimab combined with these novel targeted therapies and promising molecules.

Speaker #1: This collaboration is intended to evaluate Ibanesimab in combination with one or more of RevMed's RAS on inhibitors in pancreatic cancer, colorectal cancer, and non-small cell lung cancer.

Maky Zangeneh: This collaboration is intended to evaluate ivonescimab in combination with one or more of RevMed RAS(ON) inhibitors in pancreatic cancer, colorectal cancer, and non-small cell lung cancer. This collaboration has an opportunity to be mutually beneficial to both Summit and RevMed by leveraging a combination of potential next-generation assets that individually have promise in each setting, and this may have high promise for patients with RAS mutant cancers. In our GSK collaboration evaluating ivonescimab in multiple solid tumor settings in combination with their B7-H3 ADC, we expect the trial to initiate in mid 2026. This is another example of promising targets seeking to significantly advance outcomes in settings where both Ivo and B7-H3 ADCs have shown promise. We have over 60 ISTs that we intend to support in various stages of development.

Speaker #1: This collaboration has an opportunity to be mutually beneficial to both Summit and RevMed by leveraging a combination of potential next-generation assets that individually have promise in each setting, and this may have high promise for patients with RAS mutant cancers.

Speaker #1: In our GSK collaboration evaluating Ibanesimab in multiple solid tumor settings in combination with their B7H3 ADC, we expect the trial to initiate in mid-2026.

Speaker #1: This is another example of promising targets seeking to significantly advance outcomes in settings where both IBO and B7H3 ADCs have shown promise. We have over 60 ISTs that we intend to support in various stages of development; of these, 15 are currently enrolling. Five of these are in collaboration with MD Anderson, and Ibanesimab has now been featured in over 45 publications, presentations, and posters.

Maky Zangeneh: Of these, 15 are currently enrolling, five of these in collaboration with MD Anderson, and ivonescimab has now been featured in over 45 publications, presentations, and posters. Collectively, these trials enhance and inform our own clinical development activities as we learn more about new settings where neither we nor Akeso have had the opportunity to explore yet. Tremendous interest, interest in ISTs is a testament to the enthusiasm we have heard from many investigators as they consider the potential opportunity that ivonescimab presents across multiple tumor types. Over the past 18 months, we have seen four positive randomized Phase III trials, including the first and only Phase III trials, to compare positively against anti-PD-1 therapies. Each of these studies represent a benefit either over a PD-1 inhibitor or in setting where PD-1 inhibitors have failed to achieve a benefit in either PFS or OS.

Speaker #1: Collectively, this trial enhances an informed our own clinical development activities as we learn more about new settings, where neither we nor ECHESO have had the opportunity to explore yet.

Speaker #1: Tremendous interest in ISTs is a testament to the enthusiasm we have heard from many investigators as they consider the potential opportunity that Ibanesimab presents across multiple tumor types.

Speaker #1: Over the past 18 months, we have seen four positive randomized Phase III trials including the first and only Phase III trials to compare positively against anti-PD-1 therapies.

Speaker #1: Each of these studies represents a benefit either over a PD-1 inhibitor or in settings where PD-1 inhibitors have failed to achieve a benefit in either PFS or OS.

Speaker #1: ECHESO's Harmony II PFS results showed Ibanesimab monotherapy as superior to Keytruda in frontline non-small cell lung cancer. These results represent the first time any therapy has achieved a clinically meaningful benefit over Keytruda in randomized Phase III trials.

Maky Zangeneh: Akeso's HARMONi-2 PFS results showed ivonescimab monotherapy as superior to Keytruda in frontline non-small cell lung cancer. These results represent the first time any therapy has achieved a clinically meaningful benefit over Keytruda in randomized Phase 3 trials. In April 2025, Akeso announced that HARMONi-2 achieved a clinically meaningful overall survival hazard ratio below 0.8 at this early look. Moving to Akeso's HARMONi-6 frontline non-small cell lung cancer study in patients with squamous histology, results were announced at ESMO 2025, demonstrating ivonescimab with chemo was superior to PD-1 plus chemo in PFS. With this result, HARMONi-2 and HARMONi-6 represent the first and only known regimens to achieve a clinically meaningful benefit, replacing an anti-PD-1 regimen. In EGFR mutant non-small cell lung cancer, both Akeso's HARMONi-A trial and our own global HARMONi trial achieved positive, consistent results.

Speaker #1: In April of 2025, ECHESO announced that Harmony II achieved a clinically meaningful overall survival hazard ratio below 0.8 at this early look. Moving to ECHESO's Harmony VI frontline non-small cell lung cancer study in patients with squamous histology, results were announced at ESMO 2025 demonstrating Ibanesimab with chemo was superior to PD-1 plus chemo in PFS.

Speaker #1: With these results, Harmony II and Harmony VI represent the first and only known regimens to achieve a clinically meaningful benefit replacing an anti-PD-1 regimen.

Speaker #1: In EGFR-mutant non-small cell lung cancer, both Echeso's Harmony A trial and our own global Harmony trial achieved positive, consistent results. In Harmony, a positive overall survival trend was observed with a hazard ratio of 0.79, barely missing statistical significance.

Maky Zangeneh: In HARMONi, a positive overall survival trend was observed with hazard ratio of 0.79, barely missing statistically significance. In a subsequent analysis in September 2025, with longer-term follow-up on Western patients, ivonescimab plus chemo showed a favorable trend in the overall survival, with a hazard ratio of 0.78 and a corresponding nominal P value of 0.0332. In HARMONi-A, Akeso's final overall survival analysis showed ivonescimab plus chemo achieve a statistically significant hazard ratio of 0.74, with a P value of 0.019, supporting a treatment profile where OS does not degrade, but rather improves over time in this setting. Turning to our market opportunity, the value proposition is clear. Ivonescimab, on its own, has the potential to be a platform blockbuster drug.

Speaker #1: In a subsequent analysis in September 2025, with longer-term follow-up on Western patients, Ibanesimab plus chemo showed a favorable trend in overall survival with a hazard ratio of 0.78 and a corresponding nominal p-value of 0.0332.

Speaker #1: In Harmony A, ECHESO's final overall survival analysis showed Ibanesimab plus chemo achieved a statistically significant hazard ratio of 0.74 with a p-value of 0.019, supporting a treatment profile where OS does not degrade but rather improves over time in this setting.

Speaker #1: Turning to our market opportunity, the value proposition is clear. Ibanesimab on its own has the potential to be a platform blockbuster drug. Additionally, novel-novel combinations with IVO could bring potential improvements over current standard of care, which could expand market opportunity further.

Maky Zangeneh: Additionally, novel-novel combinations with Ivo could bring potential improvements over current standard of care, which could expand market opportunity further. ivonescimab is well positioned to make a significant impact across the solid tumor treatment landscape. Between checkpoint inhibitors and anti-VEGF therapies, TD Cowen and others estimate the total addressable market to be in excess of $100 billion globally. Looking only at the checkpoint inhibitor market for non-small cell lung cancer, market estimates for immunotherapy are expected to exceed $20 billion by 2028. Yet, these estimates still do not include the full impact ivonescimab could have, as it has already shown promising data in multiple tumor types where checkpoint inhibitors have not been effective, including EGFR mutant non-small cell lung cancer and PD-L1-low triple-negative breast cancer.

Speaker #1: Ibanesimab is well positioned to make a significant impact across the solid tumor treatment landscape. Between checkpoint inhibitors and anti-VEGF therapies, TD Cohen and others estimate the total addressable market to be in excess of $100 billion globally.

Speaker #1: Looking only at the checkpoint inhibitor market for non-small cell lung cancer, market estimates for immunotherapy are expected to exceed $20 billion by 2028.

Speaker #1: And yet, these estimates still do not include the full impact Ibanesimab could have as it has already shown promising data in multiple tumor type where checkpoint inhibitors have not been effective including EGFR mutant non-small cell lung cancer and PD-L1 low triple negative breast cancer.

Speaker #1: Ibanesimab's differentiated profile supports its platform potential across multiple indications, many of which could be blockbuster opportunities on their own. We have a very exciting year ahead.

Maky Zangeneh: Ivonescimab differentiated profile support its platform potential across multiple indications, many of which could be blockbuster opportunities on their own. We have a very exciting year ahead. Here are some of the upcoming milestones we expect to reach in 2026 and into the first half 2027. Our global clinical studies pipeline will continue to expand, and we will provide further details in 2026 as we begin studies in new settings and indications. This will include additional novel-novel combinations, as well as the new Phase 3 studies that we intend to launch in 2026. The first steps with respect to this expansion came today with the announcement of the cooperative group-led ILLUMINE Phase 3 clinical study in head and neck cancer. We will continue to expand upon the details of our clinical development plan throughout 2026, including sponsored studies....

Speaker #1: Here are some of the upcoming milestones we expect to reach in 2026 and into the first half of 2027. Our global clinical studies pipeline will continue to expand.

Speaker #1: And we will provide further details in 2026 as we begin studies in new settings and indications. This will include additional novel-novel combinations, as well as the new Phase III studies that we intend to launch in 2026.

Speaker #1: The first steps with respect to this expansion came today with the announcement of the cooperative group-led ILLUMIN Phase III clinical study in head and neck cancer.

Speaker #1: We will continue to expand upon the details of our clinical development plan throughout 2026 including sponsored studies. With today's Harmony III update, we anticipate an interim PFS analysis for the squamous cohort to occur next quarter.

Maky Zangeneh: With today's HARMONi-03 update, we anticipate an interim PFS analysis for the squamous cohort to occur next quarter. Final PFS and interim OS data are expected in the second half of this year. In the HARMONi-03 non-squamous cohort, we expect to complete enrollment this year. We anticipate final progression-free survival data in the first half of 2027. As already discussed, we are looking forward to a potential first approval for ivonescimab in the US around our 14 November PDUFA date based on our HARMONi BLA filing. Now, I will turn the call over to Manmeet to provide a financial and operational update for the quarter. Manmeet?

Speaker #1: Final PFS and interim OS data are expected in the second half of this year. In the Harmony III non-squamous cohort, we expect to complete enrollment this year.

Speaker #1: We anticipate final progression-free survival data in the first half of 2027. And as already discussed, we are looking forward to a potential first approval for Ibanesimab in the US around our November 14 PDUFA date based on our Harmony BLA filing.

Speaker #1: Now, I will turn the call over to Manmeet to provide a financial and operational update for the quarter. Manmeet, thank you, Maki, and good afternoon, everyone.

Manmeet Soni: Thank you, Maky, and good afternoon, everyone. On the financials front, let me start with our cash position. We ended the year 2025 with a strong cash position of approximately $713.4 million. To remind everyone, currently, we have no debt. Turning to operating expenses, I will provide details on both GAAP and non-GAAP numbers. You can refer to our press release issued this afternoon for a reconciliation of GAAP to non-GAAP financial measures. As a reminder, non-GAAP expenses exclude stock-based compensation expenses. Total GAAP operating expenses for Q4 2025 were $225 million, compared to $234.2 million for Q3 2025.

Speaker #1: On the financials front, let me start with our cash position. We entered the year 2025 with a strong cash position of approximately $713.4 million.

Speaker #1: And to remind everyone, currently we have no debt. Turning to operating expenses, I will provide details on both GAAP and non-GAAP numbers. You can refer to our press release issued this afternoon for a reconciliation of GAAP to non-GAAP financial measures.

Speaker #1: As a reminder, non-GAAP expenses exclude stock-based compensation expenses. Total GAAP operating expenses for the fourth quarter of 2025 were $225 million, compared to $234.2 million for the third quarter of 2025.

Speaker #1: This decrease in GAAP operating expenses was primarily due to the lower stock-based compensation expense of $19.1 million, and this was offset by an increase in our clinical trial-related spend of $8.8 million.

Manmeet Soni: This decrease in GAAP operating expenses was primarily due to the lower stock-based compensation expense of $19.1 million, and this was offset by an increase in our clinical trial-related spend of $8.8 million. Overall, our non-GAAP operating expenses during the Q4 2025 were $113.3 million, compared to $103.4 million for the Q3 2025. This increase in non-GAAP operating expenses was primarily related to an increase in R&D expenses related to HARMONi-3 and HARMONi-7 trials. As you will note, we have been very efficient and disciplined in controlling our G&A spend. Our total G&A spend, excluding stock-based compensation expense, has been approximately $43 million for the full year 2025, with a run rate of approximately $10 to 11 million per quarter in 2025.

Speaker #1: Overall, our non-GAAP operating expenses during the fourth quarter of 2025 were $113.3 million compared to $103.4 million for the third quarter of 2025. This increase in non-GAAP operating expenses was primarily related to an increase in R&D expenses related to Harmony III and Harmony VII trials.

Speaker #1: As you will note, we have been very efficient and disciplined in controlling our GNS spend. Our total GNS spend, excluding stock-based compensation expense, has been approximately $43 million for the full year 2025, with a run rate of approximately $10 to $11 million per quarter in 2025.

Speaker #1: On the operations front, I'm extremely proud that Team Summit has been able to accelerate the enrollment of 600 squamous patients ahead of our planned timelines, which will allow us to have an interim readout by the second quarter of 2026.

Manmeet Soni: On the operations front, I'm extremely proud that Team Summit has been able to accelerate the enrollment of 600 squamous patients ahead of our planned timelines, which will allow us to have interim readout by Q2 2026. With the acceptance of our BLA with FDA, we have accelerated our commercial readiness activities to prepare for our potential commercial launch of EGFR mutant non-small cell lung cancer post-TKI therapy. With respect to manufacturing and drug supply readiness, we have successfully transferred and validated the production process of ivonescimab to a US-based manufacturer. With that, I will hand it back over to Dave.

Speaker #1: With the acceptance of our BLA with the FDA, we have accelerated our commercial readiness activities to prepare for our potential commercial launch of EGFR mutant non-small cell lung cancer post-TKI therapy.

Speaker #1: With respect to manufacturing and drug supply readiness, we have successfully transferred and validated the production process of Avanis Map to a US-based manufacturer. And with that, I will hand it back over to Dave.

Speaker #2: Thank you, team. And we will now see if there are any questions that our team can help answer. Operator, if you could please open the line for questions.

Dave Gancarz: Thank you, team. We will now see if there are any questions that our team can help answer. Operator, if you could please open the line for questions.

Speaker #3: Thank you. We will now begin the question-and-answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad.

Operator: Thank you. We will now begin the question-and-answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. We'll take our first question from Salveen Richter at Goldman Sachs.

Speaker #3: To raise your hand and join the queue, if you would like to withdraw your question, simply press star one again. We'll take our first question from Salveen Richter at Goldman Sachs.

[Analyst] (Goldman Sachs): Hey, this is Mark on for Selvinn. Thank you so much for taking our question, and congrats on the quarter. Can you talk about what drove the decision to include the interim PFS analysis for HARMONi-03, for the squamous cohort, and also frame expectations for both the initial data in Q2 and also the potential final PFS analysis and interim OS in the second half? Will we see curves in addition to the top-line data? Now, given the split, do you expect that OS could reach that statistical significance by that final PFS analysis time?

Speaker #4: Hey, this is Mark on for Salveen. Thanks so much for taking our question, and congrats on the quarter. Can you talk about what drove the decision to include the interim PFS analysis for Harmony III for the squamous cohort?

Mark Aleynick: Hey, this is Mark on for Selvinn. Thank you so much for taking our question, and congrats on the quarter. Can you talk about what drove the decision to include the interim PFS analysis for HARMONi-03, for the squamous cohort, and also frame expectations for both the initial data in Q2 and also the potential final PFS analysis and interim OS in the second half? Will we see curves in addition to the top-line data? Now, given the split, do you expect that OS could reach that statistical significance by that final PFS analysis time?

Speaker #4: And also, frame expectations for both the initial data and the second quarter, and also the potential final PFS analysis and interim OS in the second half?

Speaker #4: Will we see curves in addition to the top-line data and now, given the split, do you expect that OS could reach that physical significance by that final PFS analysis time?

Speaker #2: Thanks, Mark. Appreciate the question. This is Dave. So, we decided to amend the protocol for the HARMONY III study by including an interim analysis for the PFS primary endpoint.

Dave Gancarz: Thanks, Mark. Appreciate the question. This is Dave. We decided to amend the protocol for the HARMONi-3 study by including an interim analysis for the PFS primary endpoint. If you recall, we previously amended the HARMONi-3 study in order to add PFS as a primary endpoint, in addition to overall survival. The reason for the addition of PFS as a primary endpoint was based on the results of HARMONi-2, which showed the large PFS delta that Maky spoke to, a hazard ratio of 0.51, comparing ivo to monotherapy pembro of lung cancer patients. This was then seen again in the HARMONi-6 data. This would allow for an earlier discussion with the agency based on the PFS primary endpoint, and now an interim PFS.

Speaker #2: If you recall, we previously amended the Harmony III study in order to add PFS as a primary endpoint in addition to overall survival. The reason for the addition of PFS as a primary endpoint was based on the results of Harmony II, which showed the large PFS delta that Maki spoke to, a hazard ratio of 0.51.

Speaker #2: Comparing IVO to monotherapy pembrol in lung cancer patients, and then this would allow for—so this was then seen again in the Harmony VI data.

Speaker #2: So this would allow for an earlier discussion with the agency based on the PFS primary endpoint, and now an interim PFS. So it's really about accelerating the timelines with respect to the data, based on two interim readouts from our partners at Acesso in studies in lung cancer.

Dave Gancarz: It's really about accelerating the timelines with respect to the data based on two interim readouts from our partners at Akeso in studies in lung cancer. With both studies remaining or reading out positively, the overlap and the indication with respect to HARMONi-6 that gives a strong indication in terms of the opportunity that exists here with Ivo plus chemo versus a PD-1 plus chemo here. What I would say with respect to your question on survival, and I think Maky emphasized this point a minute ago as well, overall survival will be immature at the time of the interim PFS analysis.

Speaker #2: And so with both studies, remaining or reading out positively the overlap and the indication with respect to Harmony VI, that gives a strong indication in terms of the opportunity that exists here with IVO plus chemo versus a PD1 plus chemo here.

Speaker #2: What I would say with respect to your question on survival—and I think Maki emphasized this point a minute ago as well—overall survival will be mature at the time of the interim PFS analysis.

Dave Gancarz: In terms of disclosure, on, with respect to when that will take place, we plan to run the analysis in Q2, and then ultimately from there, what gets disclosed will be determined based on output results as well as, you know, traditional major medical conference guidance, depending on how results are read out one way or the other. With respect to your final question on final PFS interim OS, that remains no real change in timing. That's the second half of this year. Again, we're not really guiding, and we don't really comment historically on our expectations with respect to results. We don't, you know, we obviously are encouraged by ivonescimab's phase II data, the phase III data that took place in HARMONi-6.

Speaker #2: In terms of disclosure, with respect to when that will take place, so we plan to run the analysis in the second quarter and then ultimately from there, what gets disclosed will be determined based on output results as well as traditional major medical conference guidance depending on how results are read out one way or the other.

Speaker #2: And then, with respect to your final question on final PFS, interim OS, there remains no real change in timing. That's the second half of this year.

Speaker #2: Again, we're not really guiding, and we don't really comment historically on our expectations with respect to results. We obviously are encouraged by ivonesimab's phase two data and the phase three data that took place in Harmony VI, and so we really are looking to continue to follow those trends, but don't necessarily guide specifically with respect to our expectations numerically, if you will.

Dave Gancarz: We really, you know, are looking to continue to, you know, follow in those trends, but don't necessarily guide specifically with respect to our expectations numerically, if you will.

Speaker #4: Excellent. Thank you.

[Analyst] (Evercore ISI): Excellent. Thank you.

Mark Aleynick: Excellent. Thank you.

Speaker #3: We'll go next to Yigal Nachomovich at Citi.

Operator: We'll go next to Yigal Nochomovitz at Citigroup.

Speaker #4: Hey, great. Thank you very, very much for taking the questions and for the comprehensive update, Maki and team. So just to kind of press further on this question around this interim PFS and the second quarter now.

Yigal Nochomovitz: Hey, great. Thank you very, very much for taking the questions and for the comprehensive update, Maky and team. Just to kind of press further on this question around this interim PFS in the Q2 now. It, it sounds like what you're saying is that, you know, this is based on the optimism from the HARMONi-2 and HARMONi-6, but I just want to check. Was there anything specific that you saw in HARMONi-3, you know, with respect to an event rate that's faster, or other new piece of information that increased your confidence in doing this interim now in the Q2? Or is it, is it really just a question of, you know, providing this update sooner to accelerate development, you know, based on, as you pointed out, what you, what you saw with HARMONi-2 and HARMONi-6? Thank you.

Speaker #4: So it sounds like what you're saying is that this is based on the optimism from Harmony II and Harmony VI, but I just want to check, was there anything specific that you saw in Harmony III with respect to an event rate that's faster or other new piece of information that increased your confidence in doing this interim now in the second quarter?

Speaker #4: Or is it really just a question of providing this update sooner to accelerate development? Based on, as you pointed out, what you saw with Harmony II and Harmony VI.

Speaker #4: Thank you.

Speaker #2: Yeah. Thanks, Yigal, for the question. It's really a data-backed decision. As we mentioned, with respect to interim readouts for Harmony II and VI, and then obviously the significant overlap in setting with Harmony VI, I would also re-emphasize we are not changing the timing in terms of guiding towards final PFS expectations and then the interim OS.

Dave Gancarz: Yeah, thanks, Yigal, for the question. It's really a data-backed decision, as we mentioned, with respect to interim readouts for HARMONi-2 and 06, and then obviously the significant overlap in setting with HARMONi-6. I would also reemphasize, we are not changing the timing, in terms of, you know, guiding towards final PFS expectations and then the interim OS, so no, no change there from events. I'll let Alan provide more commentary as well.

Speaker #2: So no change there from events. I'll let Alan provide more commentary as well.

Speaker #5: Yeah, Yigal. I think what you said—it's the latter. Remember, this study was designed way back in '23, right? And since then, we've had the Harmony II and the Harmony VI readout.

Allen Yang: Yeah, Yigal, I think what you said, it's the latter. Remember, this study was designed way back in 2023, right? Since then, we've had the HARMONi-2 and the HARMONi-6 readout. Our mission has always to been, bring this very important medicine, which we think is a game changer, to patients as soon as possible, right? I think the HARMONi-2, and now the HARMONi-6 data, gives us growing confidence. Now, granted, both of those studies read out on an interim PFS, which was very dramatic, and PFS is a surrogate endpoint, so there'll have to be some regulatory discussion, but we'll need to look at that data before we can make those decisions. Again, I think this is an opportunity to bring patients faster.

Speaker #5: Our mission is always to bring this very important medicine, which we think is a game changer, the patient's as soon as possible, right? And I think the Harmony II and now the Harmony VI data gives us growing confidence.

Speaker #5: Now, granted, both of those studies read out on an interim PFS, which was very dramatic, and PFS is a surrogate endpoint. So they'll have to be some regulatory discussion, but we'll need to look at that data before we can make those decisions.

Speaker #5: But again, I think this is an opportunity to bring patients faster.

Speaker #4: Okay. And at this point, are you providing any other details with respect to the alpha spend or the number of events that are triggering this interim in the second quarter?

Yigal Nochomovitz: Okay. At this point, are you providing any other details with respect to the alpha spend or the number of events that are triggering this interim in Q2?

Speaker #2: No, nothing in terms of a statistical plan at this point has been provided, neither for the interim PFS nor the final. But we have provided approximate sample sizes for both cohorts, and then, obviously, the primary endpoints of both PFS and OS.

Dave Gancarz: No, nothing in terms of a statistical plan at this point has been provided, neither for the interim PFS nor the final. You know, we have provided, you know, approximate sample sizes for both cohorts, and then obviously the primary endpoints of both PFS and OS.

Speaker #4: Okay. And then, totally separate question—I just want to comment or ask about Illumine. So, is there... it had the data in ESMO in 2024.

Yigal Nochomovitz: Okay. A totally separate question. I just want to, you know, comment or ask about ILLUMINE. You had the data in ESMO in 2024. What do you know about contribution of components with respect to ivonescimab and ligufalimab? Is there evidence to suggest synergy, or not? Or is this just an additive effect? If you could just spend a little bit more time explaining, you know, the thinking scientifically to put those two together. I know the ESMO data was a little bit of time ago, back in 2024.

Speaker #4: What do you know about contribution of components with respect to IVO and Legefalimab? Is there evidence to suggest synergy or not? Or is this just an additive effect?

Speaker #4: If you could just spend a little bit more time explaining the thinking scientifically to put those two together. I know that ESMO data was a little bit of time ago, back in 2024.

Speaker #2: Sure, Yigal. Thanks for the question. So if you recall from ESMO 2024, we showed data that was generated from our partners at Acesso both in monotherapy, Ivanesimab, as well as Ivanesimab in combination with Legefalimab that is Maki explained was Acesso's proprietary CD47 antibody.

Dave Gancarz: Sure, Yigal. Thanks for the question. If you recall from ESMO 2024, we showed data that was generated from our partners at Akeso, both in monotherapy ivonescimab, as well as ivonescimab in combination with ligufalimab. That, as Maky explained, was Akeso's proprietary CD47 antibody. That data was encouraging in both cohorts, but it did show an additional uplift that was seen with ivonescimab plus ligufalimab. We've seen our partners at Akeso launch a Phase III study with the combination in PD-L1 positive head and neck cancer. We've explored and have been encouraged by this data as it continues to, the Phase II data continues to mature.

Speaker #2: And that data was encouraging in both cohorts, but it did show an additional uplift that was seen with Ivanesimab plus Legefalimab. And so we've seen our partners at Acesso launch a phase three study with the combination in PDL1 positive head and neck cancer.

Speaker #2: And so we've explored and have been encouraged by this data as it continues—the phase two data continues to mature. And part of the study, being a three-arm study, with IVO in one arm, IVO plus Legefalimab in the second arm, and then the control arm being monotherapy Pembro.

Dave Gancarz: Part of the study being a three-arm study, with Ivo in one arm, Ivo plus ligufalimab in the second arm, the control arm being monotherapy pembro. That will help answer definitively that question, with respect to contribution of components. The two cohorts within the Phase II each were encouraging, and there was encouragement from the cooperative group in GORTEC, I'd like to obviously, you know, thank GORTEC for, you know, their enthusiasm in terms of the study. That's, you know, what's, what's led to the progression here.

Speaker #2: That will help answer definitively that question with respect to contribution of components. But the two cohorts within the phase two each were encouraging. And there was encouragement from the cooperative group in GORTEC, and I'd like to obviously thank GORTEC for their enthusiasm in terms of the study.

Speaker #2: And that's what has led to the progression here.

Speaker #5: Yeah. I would just add that, as Dave said, Yigal, the data from ESMO showed that the combination of Legefalimab and Ivanesimab had a higher overall response rate than Ivanesimab alone.

Allen Yang: Yeah. I would just add that, you know, as Dave said, Yigal, that the, you know, the data from ESMO showed that the combination of ligufalimab and ivonesimab was, had no higher overall response rate than ivonesimab alone. We're excited to work with GORTEC, which is a premier cooperative group in head and neck cancers, and they've designed a very rigid, clinically sound, scientifically robust study to demonstrate that. I think Maky's comments in the script showed that there are going to be ivonesimab as one group and ivonesimab plus ligofilimab. You can demonstrate the contribution of components against the standard of care, pembrolizumab. I think that's going to be very important.

Speaker #5: We're excited to work with GORTEC, which is a premier cooperative group in head and neck cancers, and they've designed a very rigid clinically sound scientifically robust study to demonstrate that.

Speaker #5: And I think Maki's comments in the script showed that there are going to be Ivanesimab as one group and Ivanesimab plus Legefalimab. So you can demonstrate the contribution of components against the standard of care, Pembrolizumab.

Speaker #5: So I think that's going to be very important.

Speaker #4: Thank you. Thank you.

[Analyst] (Evercore ISI): Thank you. Thank you.

Yigal Nochomovitz: Thank you. Thank you.

Speaker #1: Next, we'll move to Brad Canino at Guggenheim.

Operator: Next, we'll move to Bradley Canino at Guggenheim.

Speaker #6: Hey, afternoon. Congrats on the screening completion. For me, it's not quite clear yet why adding the interim provides a benefit where the regulatory discussions, because it seems like you'll reach final PFS before any OS data, interim or final, and presumably you would need the OS to file anyway.

Bradley Canino: Hey, afternoon. Congrats on the screening completion. For me, it's not quite clear yet why adding the interim provides a benefit with regulatory discussions, because it seems like you'll reach final PFS before any OS data, interim or final. Presumably, you would need the OS to file anyway. Can you help square that for me? Sorry to beat the horse on this one.

Brad Canino: Hey, afternoon. Congrats on the screening completion. For me, it's not quite clear yet why adding the interim provides a benefit with regulatory discussions, because it seems like you'll reach final PFS before any OS data, interim or final. Presumably, you would need the OS to file anyway. Can you help square that for me? Sorry to beat the horse on this one.

Speaker #6: So can you help square that for me? And sorry to beat the horse on this one.

Speaker #2: No, great. Thanks for the question, Brad. And so I think there's a couple of things in terms of what you said. So, first of all, you can't really have a discussion with respect to data with the regulatory agencies without data, right?

Dave Gancarz: Oh, no. Great. Thanks for the question, Brad. I think there's a couple things in terms of what you said. First of all, you can't really have a discussion with respect to data with the regulatory agencies without data, right? Part of, part of the interim analysis allows for the generation of primary endpoint-based data. You know, as we continue to mature that data, you'll see also, you know, no change in our guidance with respect to final PFS as well as interim OS timing in the second half of the year as well.

Speaker #2: And so, part of the interim analysis allows for the generation of primary endpoint-based data. And then, as we continue to mature that data, you'll see also no change in our guidance with respect to final PFS as well as interim OS timing in the second half of the year as well.

Speaker #2: And so when you kind of combine those two points, it allows for the acceleration of the conversation without much delay with respect to there's several months in between, obviously, second quarter versus the second half of the year, but it allows for progressing that conversation with the agency with data in hand to allow for next steps.

Dave Gancarz: So when you kind of combine those two points, it allows for the acceleration of the conversation, without much delay with respect to, you know, there's several months in between, obviously, Q2 versus the second half of the year, but it allows for progressing that conversation with the agency, with data in hand to allow for next steps.

Speaker #6: And I guess when I hear this, and along with the regulatory strategy in EGFR mutants, should we read this as a company's evolving view that frontline lung could see approvals with just PFS benefits and only OS trends?

Bradley Canino: I guess when I hear this, and along with the regulatory strategy in EGFR mutant, should we read this as, like, a company's evolving view that frontline lung could see approvals with just PFS benefits and only OS trends? Thank you.

Brad Canino: I guess when I hear this, and along with the regulatory strategy in EGFR mutant, should we read this as, like, a company's evolving view that frontline lung could see approvals with just PFS benefits and only OS trends? Thank you.

Speaker #6: Thank you.

Speaker #2: Yeah. I mean, I think depending on it's a combination, right? It depends on the timing, right? The magnitude of the benefit is important. And then obviously, there'll be some contribution in terms of overall survival trends.

Dave Gancarz: Yeah, I mean, I think there, you know, depending on... It's a combination, right? It depends on the timing, right? The magnitude of the benefit is important. Then obviously, there'll be some contribution in terms of, you know, overall survival trends. I think that's where we see dual primary endpoints in this study, and then across solid tumors, you see that in several places as well. The study is, to be clear, is certainly powered for both primary endpoints, which is an important point as well.

Speaker #2: And I think that's where we see dual primary endpoints in this study. And then across solid tumors, you see that in several places as well.

Speaker #2: The study is, to be clear, certainly powered for both primary endpoints, which is an important point as well.

Speaker #5: So Brad, this is Manmeet. I think, in other words, right, depending upon this earlier interim PFS data and the magnitude of the PFS, that will allow us a potential discussion with the FDA to accelerate our submission. As we submit, right, OS may come and mature, and that is the path forward to accelerate providing this drug to patients much earlier.

Allen Yang: Brad, this is Ameet. I think in other words, right, depending upon this earlier interim PFS data and the magnitude of the PFS, that will allow us a potential discussion with the FDA to accelerate our submission. As we submit, right, OS may come and mature, and that is the path forward to accelerate providing this drug to patients much earlier.

Manmeet Soni: Brad, this is Ameet. I think in other words, right, depending upon this earlier interim PFS data and the magnitude of the PFS, that will allow us a potential discussion with the FDA to accelerate our submission. As we submit, right, OS may come and mature, and that is the path forward to accelerate providing this drug to patients much earlier.

Speaker #6: Okay. Thank you.

Bradley Canino: Okay, thank you.

Brad Canino: Okay, thank you.

Speaker #1: We'll go next to Corey Kazimov at Evercore ISI.

Operator: We'll go next to Cory Kasimov at Evercore ISI.

Speaker #7: Hi. This is Josh on for Corey Kazimov. Thanks for taking our question. Our question is on the head and neck phase three. Why opt to go through a co-op group here?

[Analyst] (Evercore ISI): Hi, this is Josh on for Cory Kasimov. Thanks for taking our question. Our question is on the head and neck Phase 3. Why opt to go through a co-op group here, and what signal will you want to see before committing to expanding into the US here, and could it be used to leverage for a US approval?

Speaker #7: And what signal will you want to see before committing to expanding into the US here? And could it be used to leverage for a US approval?

Speaker #2: Yeah. Hey, Josh. Thanks for the question. So a couple of points there. I think one we've talked a few times now in terms of expanding our phase three program more broadly.

Dave Gancarz: Yeah. Hey, Josh, thanks for the question. A couple points there. I think one, we've talked a few times now in terms of expanding our Phase III program more broadly. I think in some ways there's an opportunity to work with some of the premier cooperative groups in terms of adding additional indications that we see promise in as well, and this is one of those indications. There's a highly competitive space in head and neck cancer, and we think there are multiple opportunities for patients in this setting, and we think ivonescimab presents a strong opportunity. In particular, ivonescimab, and then potentially ivonescimab in combination with ligofilimab, right? Working with cooperative groups also expands the number of trials that are able to be performed ultimately.

Speaker #2: So I think in some ways, there's an opportunity to work with some of the premier cooperative groups in terms of adding additional indications that we see promise in as well.

Speaker #2: And this is one of those indications. There's a highly competitive space in head and neck cancer, and we think there are multiple opportunities for patients in the setting.

Speaker #2: And we think Ivanesimab presents a strong opportunity in particular. Ivanesimab and then potentially Ivanesimab in combination with Legefalimab, right? And so working with cooperative groups also expands the number of trials that are able to be performed ultimately.

Speaker #2: And so, it's important that we are taking on as many opportunities as we can with respect to bringing Ivanesimab to as broad a set of patients who are impacted by cancer as we can.

Dave Gancarz: It's important that we are taking on as much opportunities as we can with respect to bringing ivonescimab to as broad of a, a set of patients who are impacted by cancer as we can. We think that that is a strong approach overall. It's a strong cooperative group who's run multiple studies as well, and they were highly enthusiastic based on the data that's been presented and obviously working with them since. As Maky emphasized earlier as well, it's important to note that we do plan to continue to expand that Phase III program in 2026.

Speaker #2: So we think that that is a strong approach overall. It's a strong cooperative group who's run multiple studies as well, and they were highly enthusiastic based on the data that's been presented and obviously working with them since.

Speaker #2: And so as Maki emphasized, earlier as well, it's important to note that we do plan to continue to expand that phase three program in 2026.

Speaker #2: And I think we've been pretty clear that, as we plan to launch additional studies, we would wait until we get to the readiness to launch, and we'd have FPI in sight.

Dave Gancarz: I think we've been pretty clear that as we plan to launch additional studies, we would wait until we get to the readiness to launch and we'd have FPI in sight. Part of this will be over the course of 26, but this was an important concept that we had with respect to working with a highly enthusiastic cooperative group in a setting which they specialize, and it was an opportunity to really explore on a multi-regional setting, this, this, these two regimens, really, the monotherapy as well as the combination regimen.

Speaker #2: And so part of this will be over the course of '26, but this was an important concept that we had with respect to working with a highly enthusiastic cooperative group in a setting which they specialize in.

Speaker #2: It was an opportunity to really explore, on a multi-regional setting, these two regimens—really, the monotherapy as well as the combination regimen.

Speaker #7: Got it. And anything on yeah, go ahead then. Sorry.

[Analyst] (Evercore ISI): Audited, anything. Yeah, go ahead. Sorry.

Allen Yang: I was just going to add, they approached us, right? They came to us. You know, head and neck is an unmet need. It's not the largest unmet need in the PD-1/VEGF space. I think we are going to, as Dave said, focus our resources on the largest unmet needs. This one was convenient because they came to us, wanting to do a study. Yeah. Sorry, Josh, I interrupted you.

Speaker #5: I was just going to add they approached us, right? So they came to us head and neck is an unmet need. It's not the largest unmet need in the PD-1 VEG-F space.

Speaker #5: And so, I think we're going to, as Dave said, focus our resources on the largest unmet needs. And this one was convenient because they came to us wanting to do a study.

Speaker #5: Yeah. Sorry, Josh, I interrupted you.

[Analyst] (Evercore ISI): No, no, thanks, Allen. I was going to ask if there was anything specific you could give us on what may trigger, like, a US expansion here?

Speaker #7: No, no. Thanks, Alan. I was going to ask if there was anything specific you could give us on what may trigger a US expansion here.

Dave Gancarz: Yeah, not, I, I don't know that at this time we want to start disclosing specific details, but obviously, we'll get enthusiasm with respect to enrollment. There's several countries in Europe who are enrolling in the study. Feedback from GORTEC as they operationalize the study. There's also additional data being generated by our partners at Akeso in Phase 3 in China with respect to the setting. I think there's a multitude of different, you know, and there is continuing maturity of the Phase 2, obviously, as well. There's multiple paths with respect to that, but nothing more specific there, Ray, just at this point.

Speaker #2: Yeah. I don't know that at this time we want to start disclosing specific details, but obviously, we'll get enthusiasm with respect to enrollment. There's several countries in Europe who are enrolling in the study feedback from Gore-Tech as they operationalize the study.

Speaker #2: There's also additional data being generated by our partners at Acasso in phase three, in China, with respect to the setting. So I think there's a multitude of different and there is continuing maturity of the phase two, obviously, as well.

Speaker #2: So, there's multiple paths with respect to that, but nothing more specific there—just at this point.

Speaker #7: Got it. Thank you.

[Analyst] (Evercore ISI): Got it. Thank you.

Speaker #1: We'll take our next question from Tyler Van Buren at TD Cowen.

Operator: We'll take our next question from Tyler Van Buren at TD Cowen.

Speaker #8: Hey, guys. Congrats on the squamous enrollment completion and the progress. So, should we expect the Harmony 6 OS data later this year? And how about Harmony 2 OS data as well?

Tyler Van Buren: Hey, guys. Congrats on the Squamous enrollment completion and the progress. Should we expect the HARMONi-6 OS data later this year? How about HARMONi-2 OS data as well? In general, given the upcoming HARMONi-3 OS data over the next year, can you just reiterate what gives you the most confidence that all the positive PFS data we have seen from the frontline lung cancer trials will ultimately translate to OS benefits in the frontline Western population or global studies?

Speaker #8: And in general, given the upcoming Harmony 3 OS data over the next year, can you just reiterate what gives you the most confidence that all the positive PFS data we have seen from the frontline lung cancer trials will ultimately translate to OS benefits in the frontline Western population or global studies?

Dave Gancarz: Appreciate the question, Tyler. I think, as we have said a few times, so the HARMONi-2 and the HARMONi-6 studies are studies that are conducted by and sponsored by our partners in China, in Akeso. So they have not necessarily guided in terms of looks on overall survival readouts at this point. It's important to note again, HARMONi-2 is not necessarily powered for overall survival, and was not powered for overall survival at all. That was a PFS primary endpoint exclusively. HARMONi-6 was also a PFS primary endpoint, but obviously a little bit larger in the sample size, over 500 patients.

Speaker #2: Appreciate the question,

Speaker #1: Tyler I think is we have said a few times so the , the , the Harmony two and the Harmony six studies are studies that are conducted by and sponsored by our partners in China at a .

Speaker #1: And so they have not necessarily guided in terms of looks on overall survival readouts at this point . It's important to note , again , Harmony two is not necessarily powered for overall survival .

Speaker #1: And it was not powered for overall survival at all. It was a PFS primary endpoint exclusively. HARMONY-6 was also a PFS primary endpoint, but obviously a little bit larger in the sample size.

Speaker #1: Over 500 patients . And so I think the the protocol for Harmony six was , was published . And so that would appear at some point , you know , to look like 2026 as an event .

Dave Gancarz: I think the protocol for HARMONY-6 was published, so that would appear at some point, you know, to look like 2026 is an event, but they have not guided more specifically to that. I think the second half of your question with respect to, you know, translation into HARMONY-3, and then obviously the confidence that we have, you know, with the PFS data translating to OS. I'd make a couple of points. I don't think there's a better analogy in terms of opportunity with respect to a randomized Phase 3 study, you know, in squamous non-small cell lung cancer, Ivo plus chemo versus PD-1 plus chemo, than a randomized Phase 3, you know, that was nearly identical, just run in China, right? That was strongly positive.

Speaker #1: But they have not guided more specifically to that . I think the second half of your question with respect to , you translation into Harmony three , that obviously , the confidence that we have , you know , with the PFS data translating to OS .

Speaker #1: So, I'd make a couple of points. I don't think there's a better analogy in terms of opportunity with respect to a randomized Phase III study.

Speaker #1: You know , and in this case , in squamous non-small cell lung cancer , Evo plus chemo versus PD one plus chemo , then a randomized phase three , you know , that was nearly identical .

Speaker #1: Just run in China . Right . And so that was strongly positive . The PFS hazard ratio . You know , indicated a 40% improvement in terms of PFS .

Dave Gancarz: The PFS hazard ratio, you know, indicated a 40% improvement, in terms of PFS, you know, reduction of risk and/or death. When we look at the translation from, you know, China to the global setting, we're obviously very confident, and HARMONi helped enforce that with, you know, very consistent results with respect to OS, both from a median perspective as well as, as hazard ratio. I think the other thing is, we step back. You know, we often talk about the question with respect to PFS, and hey, what's the confidence level translating that into OS? At this point, 4 randomized Phase 3s have read out, right? HARMONi-A was the first, and that was in China, the EGFR mutant non-small cell lung cancer after TKI.

Speaker #1: You know , reduction of risk and or death . And so when we look at the translation from , you know , China to the global setting , we're obviously very confident in harmony , helped enforce that with , you know , very consistent results with respect to OS , both from a median perspective as well as hazard ratio .

Speaker #1: I think the other thing is we step back , you know , we often talk about the question with respect to PFS and hey , what's the confidence level translating that into OS .

Speaker #1: And so at this point, for randomized Phase 3, have read out, right? Harmony-A was the first. And that was in China.

Speaker #1: The EGFR mutant non-small cell lung cancer after TKI in that. Final final OS analysis was statistically significant. And that was displayed at City.

Dave Gancarz: In that, final PFS, final OS analysis was statistically significant, and that was displayed at SITC. The second was the HARMONY study, and we've talked at length there with a very strong showing. With respect to overall survival, the final analysis was not statistically significant, but with longer follow-up time, given the delays in initial enrollment in the follow-up time differences between China and the US, we saw a nominal p-value that was below any threshold with respect to, you know, what would be required for significance. We saw a p-value of 0.03.

Speaker #1: The second was the Harmony study. And we've talked at length there, with a very strong showing with respect to overall survival.

Speaker #1: The final analysis was not statistically significant , but with longer follow up time , given the given the delays in initial enrollment in the in the follow up time differences between China and the US , we saw a nominal p value that was below any threshold with respect to , you know , what would would be required for significance .

Speaker #1: We saw a p value of 0.03 . When we look at Harmony two , the the only readout we've seen thus far was the nmpa .

Dave Gancarz: When we look at HARMONi-2, the only readout we've seen thus far was the NMPA, the Chinese health authority requested a look, and that showed an OS hazard ratio of 0.777, comparing Ivo to Pembro. At this point, HARMONi-6 has not even hit that point, and it's still. That application's in review, as our partners at Akeso have announced. There hasn't been a look yet at overall survival. Of the four that have read out, three of those studies have shown some data towards OS. All of them have shown a hazard ratio of less than 0.8, which when we speak to KOLs, we speak to physicians globally, that's kind of the, you know, generally agreed upon threshold for clinical meaning, clinical meaningfulness, if you will.

Speaker #1: The Chinese health authority requested . Look . And that showed a OS hazard ratio of 0.777 . Comparing Ivo to Pembro . So at this point , Harmony six is not even hit that point , and it's still that that applications in review is our partners at Exo have announced , and so there hasn't been a look yet at overall survival .

Speaker #1: But of the four that have read out , three of those studies have shown some data towards OS . All of them have shown a hazard ratio less than 0.8 , which when we speak to Kols , we speak to physicians globally .

Speaker #1: That's kind of the , you know , generally agreed upon threshold for clinical meaning clinical meaningfulness , if you will . And so the amount of encouragement that we've seen with respect to OS is about as high as you can get with respect to the time that we're at .

Dave Gancarz: So the amount of encouragement that we've seen with respect to OS is about as high as you can get with respect to the time that we're at. I appreciate everyone's, you know, focus on overall survival, but overall survival takes time in terms of the readout, and all of the readouts that we've seen to date have pointed in, in one direction, which has been highly encouraging. So hopefully, Tyler, a comprehensive answer to your question, but, you know, one that answers it. Tyler, this is Allen. I would just add from a clinical perspective, from the mechanics of the study, they're not a crossover design. The standard of care for both arms is the same, right? The patients are blinded, so they don't even know whether which arm they were on, so they should get balanced standard of care.

Speaker #1: I appreciate everyone's , you know , focus on overall survival , but overall survival takes time in terms of the readout and all of the readouts that we've seen to date have pointed in one direction , which has been highly encouraging .

Speaker #1: So hopefully Tyler , comprehensive answer to your question , but but , you know , one that answers it .

Speaker #2: And Tyler , this is Alan . I would just add from a clinical perspective , from the mechanics of the study , they're not a crossover design .

Allen Yang: Tyler, this is Allen. I would just add from a clinical perspective, from the mechanics of the study, they're not a crossover design. The standard of care for both arms is the same, right? The patients are blinded, so they don't even know whether which arm they were on, so they should get balanced standard of care.Now, if you start that standard of care in the second line or later line, 5 months later, because of the PFS benefit seen on, that should translate to a benefit in OS, right? It's just such a large magnitude in delaying that next line of therapy.

Speaker #2: The standard of care for both arms is the same , right ? And the patients are blinded so they don't even know whether which arm they were on .

Speaker #2: So they should get balanced standard of care . Now if you start that standard of care in the second line or later line , five months later , because of the PFS benefit seen on , that should translate to a benefit in OS , right ?

Dave Gancarz: Now, if you start that standard of care in the second line or later line, 5 months later, because of the PFS benefit seen on, that should translate to a benefit in OS, right? It's just such a large magnitude in delaying that next line of therapy. That's great. Thanks.

Speaker #2: It's just such a large magnitude and delaying that next line of therapy

Speaker #3: That's great . Thanks

Tyler Van Buren: That's great. Thanks.

Speaker #4: And ethical. Your line is open. Please go ahead.

Allen Yang: Asthika, your line is open. Please go ahead.

Operator: Asthika, your line is open. Please go ahead.

Speaker #5: Hi guys . Thanks for taking my questions . So I've got a question more of a commercial question here . So as you're thinking about the commercial footprint , you're going to need for EGFR mutant non-small cell lung that you're , that you're building up right now , how much does footprint could you would be usable for the broader the broader acquaintance population ?

Asthika Goonewardene: Oh, hi, guys. Thanks for taking my question. I've got a question, more of a commercial question here. As you're thinking about the commercial footprint you're going to need for EGFR mutant non-small cell lung that you're building off right now, how much of footprint could you would be usable for, for, for the broader, for the broader squamous population? I'm assuming all of that. How much more would you have to add, add on top of that to address the broader squamous population? I have a follow-up.

Speaker #5: I'm assuming all that. But then, how much more would you have to add on top of that to address the broader squamous population?

Speaker #5: And then I have a follow up .

Speaker #6: Hey , this is Manmeet and I can take that question on commercial readiness . Right . There are a lot of synergies . Right ?

Manmeet Soni: Hey, Asthika, this is Manmeet, and I can take that question on commercial readiness, right? There are a lot of synergies, right? If you see our EGFR, and squamous and non-squamous all are coming from the non-small cell lung cancer, right? As you would know it, right, most of them are treated by, by similar physicians over there. Our footprint and synergies will come, right, pretty much. EGFR is a much smaller population base. Squamous gets over, like, 2.5 to 3 times bigger than EGFR, and then non-squamous comes, which is almost double of squamous, right? It keeps expanding, but it gets our foot into the door.

Speaker #6: If you see our EGFR squamous and non-squamous , all are coming from the non-small cell lung cancer , right . And as you would note , right , most of them are treated by similar physicians over there .

Speaker #6: So our footprint and synergies will come right . Pretty much EGFR is a much smaller population . Base . Squamous gets over like 2.5 to 3 times bigger than EGFR .

Speaker #6: And then non-squamous comes which is almost double of squamous right . So it keeps expanding but it gets our foot into the door .

Speaker #6: We will have to do a lot of education, a lot of, you know, learning from our setting, our basic infrastructure in the next coming quarters.

Manmeet Soni: We will have to do a lot of education, a lot of, you know, learning from our setting, our basic infrastructure in next coming quarters, and that will be the backbone of as we expand into squamous and non-squamous, because these are all similar physicians, same institutions.

Speaker #6: And that will be the backbone as we expand into squamous and non-squamous, because these are all similar physicians, same institutions.

Speaker #5: So let .

Asthika Goonewardene: Manmeet, how should we think about, I guess, the ramp-up in your expenditure for the FDA line item?

Speaker #7: Me

Speaker #5: How should we think about, I guess, the ramp-up in your expenditure for the line item?

Speaker #6: Yeah , we have been like pretty efficient over there , as I said , EGFR is the smallest one right to initiate . We don't have to put a lot of expenditure in the most of the expenditure will come right when we hire our sales teams over there .

Manmeet Soni: Yeah, we have been, like, pretty efficient over there. As I said, EGFR is the smallest one, right, to initiate. We don't have to put a lot of expenditure, and the most of the expenditure will come, right, when we hire our sales teams over there. We have been already doing a lot of activities on the medical affairs front, which we initiated, right, last quarter, and those all are happening. I would say there will be expense, but that will come a quarter before the PDUFA, right? As you get into that, you hire more salespeople and other things. Other than that, we are already, you know, doing much of the activities and managing that right now very well.

Speaker #6: We have already been doing a lot of activities on the medical affairs front, which we initiated right last quarter, and those are all happening.

Speaker #6: So I would say there will be expense , but that will come a quarter before the right . As you get into that , you hire more salespeople and other things .

Speaker #6: But other than that , we are already , you know , doing much of the activities and managing that right now very well .

Speaker #5: Got it. Thanks for that. And then, as we're—I like that you guys are offsetting some of the development to these cooperative groups like Vertex.

Asthika Goonewardene: Got it. Thanks for that. As we're, I, I like that you guys are offsetting some of the development to these cooperative groups like GORTEC. Of course, these groups are, are, are going off the data that's generated in China, also with the, with novel agents, that are not yet, yet approved in the US and Europe. I guess, how are you thinking about, when, when you think about these, these data conversion for US submissions, how are you thinking about some of the regulatory requirements like Project Optimus, that might be required, perhaps to be done before the Phase 3 is started?

Speaker #5: But of course, these groups are going off of data that's generated in China. Also, with novel agents that are not yet approved in the US and Europe.

Speaker #5: So I guess how are you thinking about when you think about these , these data ? Convert them for us submissions ? How do you think about some of the regulatory requirements like Project optimists ?

Speaker #5: That might be required, perhaps to be done before a Phase Three is started. And how are you getting these cooperative groups to kind of play ball with that and make sure that the data that they're generating is going to be applicable for a US submission, too?

Asthika Goonewardene: How are you getting these, these cooperative groups to kind of play ball with that and, and make sure that, that the data that they're generating is going to be applicable for a US submission, too?

Speaker #1: Yeah , it's a great question . Azteca . And so importantly , our partners at Accesso have started a phase three in China in this setting .

Dave Gancarz: Yeah, it's a great question, Asthika. So importantly, our partners at Akeso have started a Phase III in China in this setting. So that also speaks to the additional data that exists with respect to some of the work that's been done in this setting. Also, there's, there's Optimus, there's, there's contribution of components, which we spoke to earlier as well. Obviously, with the novel, novel opportunity here with Ivo and Ligu, it's important to show Ivo as a monotherapy as well as Ivo and Ligu combined. So I think a lot of the concepts that you're speaking to are something that's permeating both in the US as well as Europe.

Speaker #1: And so that also speaks to the additional data that exists with respect to some of the work that's been done in this setting .

Speaker #1: And also there's there's there's there's contribution of components , which we spoke to earlier as well . And obviously with the the novel novel opportunity here with Evo and Ligue , it's important to show Evo is a monotherapy as well as Evo in Ligue combined .

Speaker #1: And so I think a lot of the concepts that you're speaking to are something that's permeating both in the US as well as Europe.

Speaker #1: The cooperative groups are very familiar with with those thought processes of the of the health authorities . And so in general , that's not something that is of high concern in terms of pushback or anything like that with the with the cooperative groups .

Dave Gancarz: The cooperative groups are very familiar with, with those thought processes of the, of the health authorities. In general, that's not something that is of high concern in terms of pushback or, or anything like that with the, with the cooperative groups. That's something that's pretty well understood at this point.

Speaker #1: That's something that's pretty well understood at this point.

Speaker #2: Yeah . Hi , this is Alan . I just add to what Dave said is that we used Chinese data clearly to satisfy project optimists before .

Allen Yang: Yeah. Hi, Asthika, this is Al. I'll just add to what Dave said, is that we've used Chinese data clearly to satisfy Project Optimus before, so that shouldn't be an issue.

Speaker #2: So that shouldn't be an issue.

Speaker #5: Got it. Thanks, guys.

Asthika Goonewardene: Got it. Thanks, guys.

Speaker #4: We'll take our next question from David Day at UBS .

Allen Yang: We'll take our next question from David Dai at UBS.

Operator: We'll take our next question from David Dai at UBS.

Speaker #5: Great . Thanks for taking my questions . Just on the Harmony . Harmony . II trial in second line GFR and lung cancer .

David Dai: Great. Thanks for taking my questions. Just on the HARMONi-A trial in second-line EGFR and also lung cancer, I mean, could you provide some additional color on the FDA interactions leading to the BLA submission? More importantly, anything to share on the FDA extent on the OS, how has that changed over time?

Speaker #5: I just could—could you provide some additional color on the FDA interactions leading to the submission, and then, more importantly, anything you can share on the FDA's stance on the OS—how has that changed over time?

Speaker #2: Yeah , this is Alan Yang . So again , I think we've been very transparent that , you know , the study is positive with a PFS endpoint .

Allen Yang: Yeah, this is Alain. Again, I think we've been very transparent that, you know, the, the study is positive with the PFS endpoint. We just missed OS because of delays in enrollment, due to sort of post effects from the pandemic. The FDA was clear that they wanted to see OS to make this a fileable package, and we said, look, we think the data are important. When we look at our data compared to other agents approved in this space, we think that this satisfies an important unmet need for patients. We wanted them to review the full package of the data. We submitted it, and they've accepted that filing, and they're reviewing the data now.

Speaker #2: We just missed OS because of delays in enrollment due to sort of post effects from the pandemic . The FDA was clear that they wanted to see OS to make this a viable package .

Speaker #2: And we said , look , we think the data are important when we look at our data compared to other agents approved in the space , we think that this satisfies an important unmet need for patients .

Speaker #2: And so we wanted them to review the full package of the data we submitted it , and they've accepted that filing . And they're reviewing the data .

Speaker #2: Now

Speaker #5: Got it . Okay . That's helpful . And then just on the most recent collaboration with GSK , with the B7-h3 ADC , in combination with Ivo .

David Dai: Got it. Okay, that's helpful. Then just on the most recent collaboration with GSK, of the B7-H3 ADC in combination with ivonescimab. Just help us understand a little more on the initial indication you're exploring. We know that the GSK is currently exploring B7-H3, for small cell lung cancer. Is, is that an indication you think it would make sense for you to explore in combination with ivonescimab?

Speaker #5: So just help us understand a bit more on the initial indication . You exploring . We know that the GSK is currently exploring B7-h3 for small cell lung cancer .

Speaker #5: Is an indication you think would make sense for you to explore in combination with Ivo .

Speaker #1: Yeah , we've specifically talked about in our press release announcing the collaboration , small Cell Lung cancer . Right . And so that is a place we've also been clear also that there's multiple solid tumor settings where we believe both B7-h3 as well as Ivo have shown promise .

Dave Gancarz: Yeah, we've specifically talked about in our press release announcing the, the collaboration, small cell lung cancer, right. That is a place. We've also been clear also that there's multiple solid tumor settings, where we believe both B7-H3 as well as ivonescimab have shown promise. There's obviously a place where with the evolving landscape of small cell lung cancer, that's an important place for us to explore. We think the B7-H3 ADC, the, that GSK has, is, is a, is you know, very much showing a lot of the. We're not going to go into details with respect to the comparisons we've done against the B7-H3s across multiple companies.

Speaker #1: And so, but there's obviously a place where, with the evolving landscape of small cell lung cancer, that's an important place for us to explore.

Speaker #1: And we think the , the b7-h3 ADC , the that GSK has is a is , you know , very much showing a lot of the we're not going to go into details with respect to the comparisons we've done against the B7-h3 across multiple companies , but it's important that we , you know , we did look at that asset and feel that that was a very appropriate partner for for Ivo , with respect to collaborating in Small Cell as well as , you know , a couple other solid tumor settings

Dave Gancarz: It's important that we, you know, we did look at that asset and feel that that was a, a very appropriate partner for, for ivonescimab with respect to collaborating in, in small cell as well as, you know, a couple other solid tumor settings.

Speaker #5: Thank you so much

Operator: Thank you so much. We'll move next to Mitchell Kapoor at H.C. Wainwright.

David Dai: Thank you so much.

Operator: We'll move next to Mitchell Kapoor at H.C. Wainwright.

Speaker #4: And we'll move next to Mitchell Kapoor at HC Wainwright.

Speaker #5: Hey everyone . Thanks for taking the questions with with Harmony under consideration from the FDA . walk through your high level thoughts on pricing strategy given the competitive landscape in EGFR non-small cell lung cancer , but also the benefit of IV Mab , what it could provide in future indications

Mitchell Kapoor: Hey, everyone. Thanks for taking the questions. With HARMONi under consideration from the FDA, could you walk through your high-level thoughts on pricing strategy, given the competitive landscape and EGFR non-small cell lung cancer, but also the benefit of ivonescimab, what it could provide in future expansion indications?

Speaker #6: Hey , Mitchell , this is Manmeet , and it's very early to start talking about pricing . Pricing Is dependent on is finally decided , right ?

Manmeet Soni: Hey, Mitchell, this is Manmeet. It's very early to start talking about pricing. Pricing is dependent on, is finally decided, right, based on the final label you have and the indication which you are launching in. Obviously, EGFR is our first one, but we will not be commenting on the price. Obviously, as you see the other benchmarks, right, you can easily look at, right, how other second-line EGFR drugs are priced. You could see that there is big range, and we have the potential, based on the benefit of ivonescimab, to price it very well. As you also stated, right, in the long run, we have multiple more indications to come, so we'll have to price it appropriately. More to come.

Speaker #6: Based on the final label you have, and the indication which you are launching in. And, obviously, EGFR is our first one.

Speaker #6: But you would not be commenting on the price . Obviously , as you see the other benchmarks . Right ? And you can easily look at right how other second line EGFR drugs are priced .

Speaker #6: You can see that there is a big range, and we have the potential—based on the benefit of having a map—to price it very well.

Speaker #6: But as you also stated , right , in the long run we have multiple more indications to come . So we'll have to .

Speaker #6: Price it appropriately , but more to come . I think there is no decision or nothing to add over here right now

Manmeet Soni: I think there is no decision or nothing to add over here right now.

Speaker #5: Okay . Fair enough . And then on on those potential expansion opportunities , obviously Ivan is kind of this pipeline in a drug opportunity , which is rare these days .

Mitchell Kapoor: Okay, fair enough. On, on those potential expansion opportunities, obviously, ivonescimab is kind of this pipeline and a drug opportunity, which is rare these days. What kind of gating items would, would, would be there to determine how fast you could initiate more trials? Is it additional partnerships or anything that can determine the next steps you take? Are you watching Akeso's next moves, or, or, what, what's helping you decide how fast to initiate additional studies?

Speaker #5: But what kind of gating items , you know , would , would , would be there to determine how fast you could initiate more trials ?

Speaker #5: Is it additional partnerships or anything that can determine the next steps you take ? Are you watching a Tezos next moves or you know what's helping you decide how fast to initiate additional studies ?

Speaker #1: Yeah , it's a great question , Mitchell . I think so is I want to emphasize one of the points that Mickey spoke to , because I think sometimes it's .

Dave Gancarz: Yeah, it's a great question, Mitchell. I think, so I, I want to emphasize one of the points that Maky spoke to, because I think sometimes it, you know, there's a lot of really positive events that take place with Ivo, and, and sometimes, it's important to slow down on a couple. Over 4,000 patients have been treated with ivonescimab just in clinical trial, clinical trials sponsored by either Summit or Akeso, right? This doesn't include the over 140 total clinical trials listed on ClinicalTrials.gov at this point. This doesn't, you know, such as ISTs and whatnot. When we look at the amount of data generated, by ivonescimab, there's a significant amount of information that can be, you know, really well understood in, in several different settings.

Speaker #1: There's a lot of really positive events that take place with Ivo and sometimes it's important to slow down on a couple . And so over 4000 patients have been treated with evinacumab just in clinical trial clinical trials sponsored by either summit or CSO .

Speaker #1: Right . So this doesn't include the over 140 total clinical trials listed on Clin Trials.gov . At this point , this doesn't , you know , such as ists and whatnot .

Speaker #1: But so when we look at the amount of data generated by Ivan , there's a significant amount of information that can be , you know , really well understood in , in several different settings .

Speaker #1: We've also , you know , it's important that our partners at Accesso have initiated ten phase three clinical studies . And so underneath that you can see the amount of data that has been generated in terms of really understanding where Ivan Mab can be successful .

Dave Gancarz: We've also, you know, it's important that our partners at Akeso have initiated 10 Phase 3 clinical studies. Underneath that, you can see the amount of data that has been generated in terms of really understanding where ivonescimab can be successful. Obviously, there's also a significant, you know, place where we can continue to explore, where maybe the prevalence of a particular disease in China is not necessarily as high as it may be in the US and vice versa, right? There's a lot of overlaps with respect to the characteristics of those diseases. That's important for us to be able to kind of translate that information across.

Speaker #1: And then obviously there's also a significant , you know , place where we can continue to explore where maybe the prevalence of a particular disease in China is not necessarily as high as it may be in the US , and vice versa .

Speaker #1: Right. But there's a lot of overlap with respect to the characteristics of those diseases. That's important for us to be able to kind of translate that information across.

Speaker #1: But because there's so much patient data with respect to how patients have performed on Ivan , that really allows us to , you triangulate , if you will , the information .

Dave Gancarz: Because there's so much patient data, with respect to how patients have performed on ivonesimab, that really allows us to, you know, triangulate, if you will, the information. We're not running, you know, hey, we, you know, we've been able to dose 30, 40, 50 patients with Ivo, and now it's very encouraging, so we are trying to figure out how to move forward. There's a plethora of information and data, you know, so much of it truly highly encouraging in terms of what that opportunity can be. That really gives us the opportunity to really think through the different places, the different standards of care. It's important to also consider what the standard of care is in some of these settings. How is that evolving? How is that evolving in the short term?

Speaker #1: So we're not running , you know , hey , you know , we've we've been able to dose 30 , 40 , 50 patients with Ivo .

Speaker #1: And now it's very encouraging . So we are trying to figure out how to move forward . There's a plethora of information and data .

Speaker #1: You know, so much of it is truly, highly encouraging in terms of what that opportunity can be. And that really gives us the opportunity to really think through the different places, the different standards of care.

Speaker #1: It's important to also consider what the standard of care is in some of these settings. How is that evolving? How is that evolving in the short term?

Speaker #1: How is that evolving? By the end of what would be a Phase 3 clinical study? And so we can really look at the information we have internally.

Dave Gancarz: How is that evolving by the end of what would be a phase three clinical study? So we can really look at the information we have internally, what's happening in the market, to really, at the end of the day, what we're trying to do is provide a medicine that improves outcomes for patients, right? That takes an ecosystem in order to do. Physicians need to be able to, you know, access, understand, and have clear You know, answers from that data. Patients need to be able to see what opportunities exist based on data and outcomes from trials.

Speaker #1: What's happening in the market to really , at the end of the day , what we're trying to do is provide a medicine that improves outcomes for patients , right .

Speaker #1: But that takes an ecosystem in order to do , physicians need to be able to , you know , access , understand and have clear , you answers from that data .

Speaker #1: Patients need to be able to see what opportunities exist based on data and outcomes from trials . And so when we look at the totality of the landscape across , you know , many of the tumor types that are sensitive either to immunotherapy , anti-angiogenic therapy , places where neither have been successful , but there's an opportunity with Ivan Mab , we really can look at the totality of the landscape , the data generated , what physicians will will need to see in a couple of years to really come up with the right answer .

Dave Gancarz: When we look at the totality of the landscape across many of the tumor types that, you know, are sensitive either to immunotherapy, anti-angiogenic therapy, places where neither have been successful, but there's an opportunity with ivonescimab, we really can look at the totality of the landscape, the data generated, what physicians will need to see in a couple of years to really come up with the right answer. That's why some of these even collaborative studies, or collaboration opportunities, rather, with RevMed, with GSK, that's important. We'll have more of those coming as well. When we look at the totality of what's out there, it's really important to consider, you know, each of those points. That's why we really look to expand much further in 2026 as well.

Speaker #1: And that's why some of these even collaborative studies are collaboration opportunities . Rather , with rev Med with GSK , that's important . We'll have more of those coming as well .

Speaker #1: But when we look at the totality of what's out there, it's really important to consider, you know, each of those points.

Speaker #1: And so that's why we really look to expand much further in 2026 as well .

Speaker #2: Yeah , Mitch and I want to just address the couple of your comments . So you know , at JPM , McKee announced that we're going to be doing multiple new phase three programs .

Allen Yang: Yeah, Mitch, I want to just address a couple of your comments. You know, at JPM, Maky announced that we're going to be doing multiple new Phase 3 programs. We will, of course, continue to explore cooperative group studies and collaborations with external partners, and you should expect more of those to come. Our strategy is not dependent on that. We will have sponsored studies based on the Akeso data and moving forward, and so you should expect more of those studies to come as well.

Speaker #2: We will, of course, continue to explore cooperative group studies and collaborations with external partners. And you should expect more of those to come.

Speaker #2: But our our our strategy is not dependent on that . We will have sponsored studies based on the data and moving forward . And so you should expect more of those studies to come as well .

Speaker #5: Wonderful . Thank you guys

Operator: Wonderful. Thank you, guys. Next, we'll go to Eric Schmidt at Cantor.

Mitchell Kapoor: Wonderful. Thank you, guys.

Operator: Next, we'll go to Eric Schmidt at Cantor.

Speaker #4: Next, we'll go to Eric Schmidt at Cantor.

Speaker #8: Well , thanks for taking my question . I wanted to go back to Harmony three and beat the horse a little bit more .

Eric Schmidt: Well, thanks for taking my question. I wanted to go back to HARMONi-3 and beat the horse a little bit more. I'm wondering if you've had discussion with the FDA around what you think would be the maximum disclosable set of information, given you need to maintain the integrity of the trial. Do you think, for example, you might be able to give us hazard ratios or any other meaningful data at that time? Thank you.

Speaker #8: I'm wondering if you've had discussion with the FDA around what you think would be the maximum disclosable set of information given ? You need to maintain the integrity of the trial .

Speaker #8: Do you think, for example, you might be able to give us hazard ratios or any other meaningful data at that time?

Speaker #8: Thank you .

Speaker #1: And , Eric , just to be clear , Eric , you're speaking about the interim PFS .

Dave Gancarz: Eric, just to be clear, Eric, you're speaking about the interim PFS?

Speaker #8: I am . Thank you Dave . Yep .

Eric Schmidt: I am. Thank you, Dave. Yep.

Speaker #1: Yeah . No , I appreciate it Eric . So I mean , look , I think and I think we kind of mutually addressed this across comments from Manmeet McKee and myself a little bit earlier .

Dave Gancarz: Yeah, no, I appreciate it, Eric. I mean, look, I, I think, and I think we, we kind of mutually addressed this across comments from Manmeet, Maky, and myself a little bit earlier. It's important that the analysis is run and that we see the analysis in terms of outcomes, in terms of what the next, you know, logical steps are in that respect. Then, obviously, positive data, you know, requires, you know, contemplation with respect to major medical conferences as well. It's, we have, you know, several, you know, opportunities, if you will, in terms of the data and what that readout will look like. As we get a little bit closer, we'll be providing, you know, a little bit more clarity on what that looks like.

Speaker #1: But it's important that the analysis is run, and that we see the analysis in terms of outcomes, in terms of what the next, you know, logical steps are in that respect.

Speaker #1: And so and then obviously , positive data , you know , requires , you know , contemplation with respect to major medical conferences as well .

Speaker #1: And so it's we have , you know , several , you know , opportunities , if you will , in terms of the data and what that readout will look like .

Speaker #1: And as we get a little bit closer, we'll be providing, you know, a little bit more clarity on what that looks like.

Dave Gancarz: Obviously, we, we thought it was very important now to provide, you know, effectively an immediate answer with respect to the analysis being, you know, run in Q2. The amount of that disclosure, in some ways, depends on, you know, what both the data shows and what the next steps are.

Speaker #1: But obviously , we thought it was very important now to provide , you know , it effectively an immediate answer with respect to the analysis being , you know , run in the second quarter and then the amount of that disclosure in some ways depends on , you know , what both the data shows and what the next steps are .

Speaker #2: Yeah .

Allen Yang: Yeah.

Speaker #8: Okay . And then

Eric Schmidt: Okay.

Allen Yang: Eric, if I could just-

Eric Schmidt: Go ahead.

Allen Yang: I, I just want to manage expectations here. You know, once we get the data, the most important thing is trying to provide this agent to patients as soon as possible. That requires a regulatory interaction, right? As a courtesy to them, we need to demonstrate to them first, right? You know, in collaboration with our investigators, we want to present this at a major medical meeting. You know, unfortunately, you know, sort of a press release, which occurs for you guys as investors and analysts, are, are not going to be a high priority for us.

Speaker #2: I just want to manage expectations here. You know, once we get the data, the most important thing is trying to provide this agent to patients as soon as possible.

Speaker #2: That requires a regulatory interaction . Right . And as a courtesy to them , we need to demonstrate to them first , right .

Speaker #2: Then , you know , in collaboration with our investigators , we want to present this at a major medical meeting . So , no , unfortunately , you know , sort of a press release with Kers for you guys as investors and analysts are not going to be a high priority for us .

Speaker #8: Well , I guess my my question was even just very specific to maintaining integrity of the final PFS readout from a regulatory standpoint and whether even if you were able to give an interim PFS readout , that would be too great a disclosure making regulators too uncomfortable .

Eric Schmidt: Well, I guess my, my question was even just very specific to maintaining integrity of the final PFS readout from a regulatory standpoint, and whether even if you were able to give an interim PFS readout, that would be too great a disclosure, making regulators too uncomfortable. Do you have a view on that?

Speaker #8: But do you have a view on that

Speaker #1: Sorry , Eric , I'm not I'm not sure . We followed exactly what .

Dave Gancarz: Sorry, Eric, I'm not, I'm not sure we followed exactly what you're-

Speaker #2: Your I think what he's saying is Eric , correct me if I'm wrong , but what you're saying is , if we were to release top line interim PFS , would that impact the study scientifically in terms of unblinding it for the final PFS ?

Allen Yang: I think what he's saying is, Eric, correct me if I'm wrong, but what you're saying is, if we were to release top line interim PFS, would that impact the study scientifically in terms of unblinding it for the final PFS, right?

Speaker #2: Right .

Speaker #8: Exactly .

Eric Schmidt: Exactly. Thank you.

Speaker #7: Thank you .

Speaker #2: Yeah , I understand what you're saying . And I guess I just don't want to disclose too much about what we're doing at this time .

Allen Yang: Yeah, I, I understand what you're saying. I guess I just don't want to disclose too much about what we're doing at this time. I understand your question. We're of course, going to take that into consideration, you know, I just don't want to disclose how we're going to do this right now.

Speaker #2: I understand your question . We're of course going to take that into consideration . But , you know , I just don't want to disclose how we're going to do this right now .

Speaker #1: Yeah , I would say a couple of key principles , right . We're never going to do anything that puts at risk the , you know , the final analysis , if you will .

Dave Gancarz: Yeah, I would say a couple of key principles, right? We're, we're never going to do anything that puts at risk the, you know, the, the, the final analysis, if you will. I think it- part of this becomes an outcomes-driven response as well in terms of what, what that data shows to be able to, you know, provide the clarity and transparency, but also be able to, you know, maintain the integrity of the study itself, as well as the interactions with the health authorities.

Speaker #1: And I think part of this becomes an outcomes driven response as well , in terms of what what that data shows to be able to , you know , provide the clarity and transparency , but also be able to , you know , maintain the the integrity of the study itself as well as the interactions with the health authorities .

Speaker #8: Okay. Thanks, guys. I appreciate all the updates.

Eric Schmidt: Okay. Thanks, guys. Appreciate all, all the updates.

Speaker #4: And we have time for one more question, and we'll take that question from Faisal Khorshid at Jefferies.

Operator: We have time for one more question, and we'll take that question from Faisal Khurshid at Jefferies.

Speaker #9: Hi . Thanks for taking the question . I wanted to ask on the FDA review for Harmony . Have you guys had any interaction with the FDA since having the Bla submitted , and is there anything in FDA's stance changing on acceptability of PFS and read through of that to Harmony ?

Operator: Hi, thank you guys for taking the question. I wanted to ask on the FDA review for HARMONi, have you guys had any interaction with the FDA since having the BLA submitted? Is there anything in the FDA's stance changing on acceptability of PFS and readthrough of that to HARMONi-3?

Faisal Khurshid: Hi, thank you guys for taking the question. I wanted to ask on the FDA review for HARMONi, have you guys had any interaction with the FDA since having the BLA submitted? Is there anything in the FDA's stance changing on acceptability of PFS and readthrough of that to HARMONi-3?

Speaker #9: Three ?

Speaker #1: Yeah , thanks . I think we addressed most of this a little bit earlier , but yes , we have interactions with the agency .

Dave Gancarz: Yeah. Thanks, Faisal. I think we addressed most of this a little bit earlier, but yes, we have interactions with the agency. We don't necessarily disclose, you know, meeting by meeting discussions and whatnot. What we don't want to do is we're not looking to leverage external sources in terms of, you know, pressuring the agency or anything like that. We have confidence. Those discussions are intended to be confidential, so we're not necessarily giving step-by-step updates with respect to that. We do have interactions with the agency, both for this study as well as, you know, other current studies and then, you know, potential future studies.

Speaker #1: We don't necessarily disclose , you know , you know , meeting by meeting discussions and whatnot . And so what we don't want to do is we're not looking to leverage external sources in terms of , you know , pressuring the agency or anything like that .

Speaker #1: We have we have confidence those discussions are intended to be confidential . So we're not we're not necessarily giving step by step updates with respect to that .

Speaker #1: But we have we do have interactions with the agency , both for this study as well as , you know , other current studies .

Speaker #1: And then , you know , potential future studies . And so it's important in terms of the totality of of what we're looking to accomplish with that .

Dave Gancarz: It's important in terms of the totality of what we're looking to accomplish with ivonescimab, that, you know, we have the utmost respect for the FDA. I think that's just a level-setting point. That becomes very important in terms of, you know, with the platform opportunity, if you will, for ivo. There's a lot of studies with a lot of potential settings where ivonescimab may bring benefit to patients, and we want to make sure that we have a strong relationship with the agency in order to do what our mission is really to bring ivonescimab to as many patients facing an unmet need as possible, in doing what's right for ultimately patients, you know, facing cancer diagnoses.

Speaker #1: We have we have the utmost respect for the FDA . I think that's a just a level setting point that becomes very important in terms of , you know , with the platform opportunity , if you will , for Ivo , there's a lot of studies with a lot of potential settings where even may bring benefit to patients .

Speaker #1: And we want to make sure that we have a strong relationship with the agency in order to do what our mission is really to bring Ivan to , to as many patients facing an unmet need as possible in doing what's right for ultimately , patients facing cancer diagnoses

Speaker #9: Understood .

Operator: Understood. Thank you.

Faisal Khurshid: Understood. Thank you.

Speaker #7: Thank you

Speaker #4: And that concludes our Q&A session. I will now turn the conference back over to Dave Gancarz for closing remarks.

Operator: That concludes our Q&A session. I will now turn the conference back over to Dave Gancarz for closing remarks.

Speaker #10: Hi , this is Bob Dugan , not only David correct in saying that we have a tremendous respect for the FDA . It is probably America's most respected agency around the world for its integrity .

Robert Duggan: Hi, this is Bob Duggan. Not only is David correct in saying that we have a tremendous respect for the FDA, it is probably America's most respected agency around the world for its integrity, the due diligence of its work, putting patients first, and we're really honored to be reporting into them. Lastly, we're also very impressed with our partner, Akeso. You know, Akeso has almost a few hundred million dollars of investment value in their ownership along with you all that are owners of Summit, and we're happy that they chose to do that. We're also quite pleased to see that time after time, when they introduce new drugs, they get through their own agency, they get clearances, they're doing quite well.

Bob Duggan: Hi, this is Bob Duggan. Not only is David correct in saying that we have a tremendous respect for the FDA, it is probably America's most respected agency around the world for its integrity, the due diligence of its work, putting patients first, and we're really honored to be reporting into them. Lastly, we're also very impressed with our partner, Akeso. You know, Akeso has almost a few hundred million dollars of investment value in their ownership along with you all that are owners of Summit, and we're happy that they chose to do that. We're also quite pleased to see that time after time, when they introduce new drugs, they get through their own agency, they get clearances, they're doing quite well.

Speaker #10: The due diligence of its work , putting patients first . And we're really honored to be reporting into them . Lastly , we're also very impressed with our our partner , you know , Kessel has almost a few hundred million dollars of investment value in their ownership , along with you .

Speaker #10: All that are owners of of summit . And we're happy that they chose to do that . We're also quite pleased to see that that that time after time when they introduce new drugs , they get through their own agency , they get clearances , they're doing quite well .

Speaker #10: It if there's any China look alike or Regeneron , it's it's a just a fabulous company with great engineers , great scientists . And we're pleased that they are the source of the bispecific tetravalent .

Robert Duggan: It, if there's any China lookalike, a Regeneron, it's Akeso, just a fabulous company with great engineers, great scientists, and we're pleased that they are the source of the bispecific tetravalent back in 2013. Yeah, we're, we're proud to have that in-licensed, and we're making great progress with that. Thank you all. We look forward to updating you on our next call, unless there's great late-breaking news in between.

Bob Duggan: It, if there's any China lookalike, a Regeneron, it's Akeso, just a fabulous company with great engineers, great scientists, and we're pleased that they are the source of the bispecific tetravalent back in 2013. Yeah, we're, we're proud to have that in-licensed, and we're making great progress with that. Thank you all. We look forward to updating you on our next call, unless there's great late-breaking news in between.

Speaker #10: Back in 2013. And we're proud to have that in-licensed, and we're making great progress with that. So thank you all, and we look forward to updating you on our next call.

Speaker #10: Unless there’s great, late-breaking news in between.

Speaker #1: Thank you .

Dave Gancarz: Thank you, everyone.

Speaker #11: Everyone

Operator: This, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Q4 2025 Summit Therapeutics Inc Earnings Call

Request a DemoDemo

SMMT

Summit Therapeutics

Earnings