Summit (SMMT) Q4 2025 Earnings Call Transcript

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Date

Feb. 23, 2026 at 4:30 p.m. ET

Call participants

• Chief Executive Officer — David Gancarz
• President and Chief Operating Officer — Manmeet Soni
• Chief Medical Officer — Allen Yang
• Chairman and Chief Executive Officer — Bob Duggan

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Takeaways

• Cash position -- Approximately $713 million at year-end, with no debt outstanding as of the call.
• GAAP operating expenses -- $225 million for 2025, down from $234.2 million, mainly due to lower stock-based compensation of $19.1 million offset by an $8.8 million rise in clinical trial-related spend.
• Non-GAAP operating expenses -- $113.3 million, up from $103.4 million, driven by research and development (R&D) expense increases related to HARMONY-3 and HARMONY-7 trials.
• General & administrative (G&A) spend -- Around $43 million for the year, with a quarterly run rate of $10 million–$11 million, excluding stock-based compensation.
• BLA filing and FDA status -- The Biologics License Application for ivonesumab in EGFR mutant non-small cell lung cancer was accepted by the FDA, with a PDUFA target action date set for Nov. 14, 2026.
• HARMONY-3 squamous cohort -- Screening completed for all 600 patients; interim progression-free survival (PFS) analysis planned in the second quarter, with final PFS and interim overall survival (OS) data expected in the second half of 2026.
• HARMONY-3 nonsquamous cohort -- Enrollment set to complete in the second half, targeting final PFS analysis in the first half of 2027.
• Additional phase III trials -- Fifteen randomized phase III trials are active, including four Summit-sponsored global studies and the newly announced ILUMIN trial in head and neck cancer with initial enrollment early next quarter.
• Commercial preparations -- Ramp-up underway for potential U.S. launch in EGFR mutant non-small cell lung cancer, including successful U.S.-based manufacturing transfer of ivonesumab.
• Clinical data and approvals -- Ivonesumab has four positive phase III readouts, two approvals in China, and over 60,000 Chinese patients treated commercially through two indications.
• Collaborative studies -- Announced collaborations with Revolution Medicine (RAF and RAS inhibitor combinations) and GSK (B7-H3 antibody-drug conjugate), with the GSK trial set to dose patients by mid-2026.
• Investigator-sponsored trials (ISTs) -- Over 60 ISTs supported, with fifteen currently enrolling and five in collaboration with MD Anderson.

Summary

Summit Therapeutics (NASDAQ:SMMT) detailed substantial operational and clinical progress, highlighting the completion of patient screening for the key squamous cohort in HARMONY-3, initiation of interim PFS and regulatory engagement milestones, and robust advancement of multiple global phase III programs. The company confirmed that the Biologics License Application for ivonesumab in EGFR mutant non-small cell lung cancer has been accepted by the FDA, with a clear PDUFA target and commercial readiness steps, including U.S. manufacturing transfer, already in execution. Extensive partnerships, notably with Revolution Medicine and GSK, expand Summit’s reach into novel combinations and new tumor types, emphasizing the company’s data-driven expansion strategy and emphasis on regulatory and clinical evidence for broad oncology markets.

• Collaboration with GoreTech introduces the ILUMIN phase III trial in head and neck squamous cell carcinoma, enrolling 780 patients across Europe and China, with U.S. expansion under consideration pending results.
• Phase II data in PD-L1 positive head and neck cancer for ivonesumab plus legofalimab demonstrated an objective response rate of 60% and median PFS of 7.1 months in twenty patients, with no treatment-related discontinuations.
• The new interim PFS analysis in HARMONY-3 squamous is specifically added to enable earlier FDA discussions, as management stated, "part of the interim analysis allows for the generation of primary endpoint based data" and "about accelerating the timelines with respect to the data."
• The company reported more than 4,000 clinical trial patients treated with ivonesumab by Summit and Akeso, with a total of 142 trials listed on clinicaltrials.gov involving the molecule.
• Initial G&A expenditures for the commercial rollout will precede the PDUFA date by about a quarter, as Soni stated, "most of the expenditure will come. Right, when we hire our sales teams over there."
• Management acknowledged that the FDA requires a statistically significant OS benefit for approval in the EGFR mutant setting, although the BLA was submitted based on positive PFS and consistent OS trends.
• Summit confirmed that study design and timing of regulatory discussion are purposefully aligned to allow interim PFS analysis without affecting the statistical integrity of the final PFS or OS endpoints.
• No pricing details were disclosed, but future pricing strategy will consider "the final label you have, and the indication which you are launching," as per Soni.

Industry glossary

• PDUFA: Prescription Drug User Fee Act; U.S. FDA deadline for regulatory action on drug approval applications.
• Progression-free survival (PFS): The period during and after medication when a patient lives with the disease without it worsening.
• Overall survival (OS): The duration from treatment start to death from any cause, used as a key endpoint in oncology trials.
• BLA: Biologics License Application; regulatory submission for marketing authorization of a biologic product in the United States.
• IST: Investigator-sponsored trial; clinical research studies initiated and managed by non-company investigators.
• CD47 monoclonal antibody: A targeted immunotherapy agent blocking the CD47 checkpoint inhibitor on cancer cells to enhance immune attack.
• ADC: Antibody-drug conjugate; a targeted cancer therapy linking an antibody to a cytotoxic drug for delivery to tumor cells.

Full Conference Call Transcript

Operator: Hello? 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 HARMONY-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 2026. 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 opened the readout of HARMONY-2, comparing ivanisimab to pembro, in PD-L positive frontline lung cancer patients, which showed a highly statistically significant and clinically meaningful benefit in PFS with a hazard ratio of 0.51 and a median improvement in PFS of over five months. This point was later validated with HARMONY-6 showing that there was a substantial PFS benefit when comparing iwanisumab plus chemo versus a PD-1 inhibitor plus chemo with a hazard ratio of 0.6.

Two phase three studies conducted by EKESO in China in frontline non-small cell lung cancer demonstrated a 40% plus improvement in PFS for the iwanisumab or Both the HARMONY-2 and HARMONY-6 PFS results were based on the planned interim PFS analysis of each study. By adding an interim PFS analysis, we opened the door to an earlier discussion with the health authorities for our multi-regional phase three study. 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 nonsquamous cohort of HARMONY-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 2027. 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 III clinical trial program, which will continue to expand throughout 2026.

ILUMIN, a new phase three study in PD-L1 positive frontline head and neck squamous cell carcinoma, will be sponsored by GoreTech, 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 ivonesumab monotherapy and in combination with legofalumab, AKSO proprietary anti-CD47 monoclonal antibody, against monotherapy pembro in this three-arm randomized study. 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 U.S. sites as well.

Phase II data supporting the potential use of ibonesumab in this patient population was previously presented at ESMO 2024, where ivanicimab in combination with legofalimab 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 abanizumab plus legofalumab discontinued treatment due to the treatment-related adverse event. The data generated in phase two is encouraging in light of existing standard of care, and EKESO is also running a single regen phase three trial this population in China. 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, abanizumab is being evaluated in combination with three RAF 1 inhibitors, including daraxone, rasip, a multi-selective RAS inhibitor, Zoldan Rasib, a KRAS G12D selective inhibitor, and alerone rasib, a KRAS G12C selective inhibitor, across multiple solid tumor settings with RAS mutation, 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 evaluate ibunasumab in combination with GSK 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 us now take a step back and look at ibunisimab accomplishments to date.

There are many to list, we are just highlighting some of them. Avanicimab has read out four phase three clinical studies to date, all four of which have had positive data, leading to two approvals in China so far. At this time, total of 15 phase three trials have been announced, currently ongoing, or have read out in multiple tumor types. Forty-four clinical trials have been initiated since 2019 between Summit and AKESO evaluating abanacumab 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 enthusiast, 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 optimist surrounding Abenisema. Together with our partner, AQESO, we have enrolled over 4,000 patients in either Summit-sponsored or Aceso-sponsored clinical trials across the world. Commercially in China, over 60,000 patients have received ivonesumab based on two approved indications by the NMPA in non-small cell lung cancer according to our partners at EKESO. A third indication based on the positive HARMONY-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 III trials evaluating abanisumab have read out to date and all four with positive data readouts. This represents the only phase three readout that we have seen in the PD-1 VEGF bispecific class today. This positive trial are supported by the in by the differentiated mechanism of action of ibonisimab. Here is the current ibonisimab development plan across Summit and ICSO.

In total, there are 15 randomized phase three 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 EKESO in China a variety of solid tumor types, including lung, breast, head and neck, BTC, pancreatic, and colorectal cancers. Additionally, AKSO is also currently enrolling multiple phase two trials evaluating avanismab in other tumor, types. Ovarian, gastric, HCC, and others including nonmetastatic settings. Through our partnership with EKESO, 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 four global Phase III trials completed or ongoing. HARMONY, which read out positively last year, HARMONY-3, HARMONY-7, HARMONY GI-3, all three of which are currently enrolling and progressing nicely. The HARMONY trial evaluated ibonisme 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, and in January, we announced the U.S. FDA’s acceptance of the filing and a PDUFA target action date of 11/14/2026.

As previously disclosed, the FDA noted that a statistically significant overall survival benefit is to support marketing authorization in this setting. Considering safety and efficacy profile of the current FDA approved options to patients in this setting, the positive regionally consistent results of this phase three multi-regional study, as well as discussions with key opinion leaders and physicians who have administered abonizumab to patients, we believe that abonizumab is a potential treatment option with a favorable benefit-risk profile. In anticipation of potential approval in Q4 of this year, we continue to ramp up commercial capabilities in preparation for potential launch. HARMONY-3 is evaluating ivanisma plus chemo against pembro plus chemo in frontline metastatic non-small cell lung cancer.

This patient population represent a significant unmet medical need, 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. For HARMONY-7, this study is evaluating abanisumab monotherapy against pembro monotherapy as frontline treatment for patients with non-small cell lung cancer that have high PD-L1 expression levels. HARMONY-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 HARMONY GI-III, evaluating abanisumab 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 in China and the United States with additional chemotherapy regimen. This dataset 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 dataset later this year as well as the HARMONY-3 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 three ILUMIN study sponsored by GORE TECH, abanisumab 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 Revolution Medicine to evaluate abanisumab in combination with three novel RAS inhibitors across multiple solid tumor settings, are excited to learn about the opportunity and potential to improve patient outcomes ibunasumab combined with this novel targeted therapies and promising molecule.

This collaboration is intended to evaluate abonizumab in combination with one or more of RevMed RAF1 inhibitors in pancreatic cancer, colorectal cancer, and non cell lung cancer. This collaboration has an opportunity to be mutually beneficial to both Summit and RevMat by leveraging a combination of potential next generation assets that individually have promised in each setting, and this may have high PROMIS for patients with RAS mutant cancers. In our GSK collaboration evaluating abonizumab 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 ISDs that we intend to support in various stages of development. Of these, 15 are currently enrolling, five of these in collaboration with MD Anderson, and iwanisumab 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 EKESO have had the opportunity to explore yet. Tremendous interest in ISTs is a testament for the to the enthusiast we have heard from many investigators as they consider the potential opportunity that ivonisumab presents across multiple tumor types.

Over the past 18 months, we have seen four positive randomized phase three trials including the first and only phase three trials to compare positively against anti-PD-1 therapies. Each of these studies represent a benefit either over a PD-1 inhibitor or in settings where PD-1 inhibitors have failed to achieve benefit in either PFS or OS. A case of HARMONY-2 PFS results showed irvonisima mono as superior to Keytruda in frontline non-small cell lung cancer. These results represent the first time any therapy has achieved a clinically benefit over Keytruda in randomized phase three trials. In April 2025, AKSO announced that HARMONY-2 achieved a clinically meaningful overall survival hazard ratio below 0.8 at this early look.

Moving to AKCEA’s HARMONY-6 frontline non-small cell lung cancer study, in patients with squamous histology, results were announced at ESMO 2025 demonstrating Avanismab with chemo was superior to PD-1 plus chemo in PFS. With this result, HARMONY-2 and HARMONY-6 represent the first and only known regimen to achieve a clinically meaningful benefit replacing an anti-PD-1 regimen. In EGFR mutant non-small cell lung cancer, both AKSO’s HARMONY A trial and our own global HARMONY trial achieved positive consistent results. In HARMONY, a positive overall survival 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, ivonisima 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. HARMONY A, a case o final overall survival analysis showed ibanisumab 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. Turning to our market opportunity, value proposition is clear, Avanismab on its own has the potential to be a platform blockbuster drug.

Additionally, novel combinations with IVO could bring potential improvements over current standard of care, which could expand market opportunity further. Avanicimab 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 hundreds billion dollars globally. Looking only at the checkpoint inhibitor market for non-small cell lung cancer, market estimates for immunotherapy are expected to exceed $20,000,000,000 by 2028.

And yet, these estimates still do not include the full impact ibonisimab 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. Avanicimab differentiated profile supports its 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 milestone 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 combinations as well as the new Phase III studies that we intend to launch in ’26. The first steps with respect to this expansion came today with the announcement of the Cooperative Group led Illumine Phase III clinical study in head and neck cancer. We will continue to expand often the details of our clinical development plan throughout 2026, including sponsored studies. With today’s HARMONY-3 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 HARMONY-3 nonsquamous cohort, we expect to complete enrollment this year.

We anticipate final progression-free survival data in the 2027. And as already discussed, we are looking forward to a potential first approval for ivonesumab in the U.S. around our November 14 PDUFA date based on our HARMONY BLA filing. Now I will turn the call over to Manmeet to provide a financial and operational update for the quarter. Manmeet?

Manmeet Soni: Thank you, Makit, and good afternoon, everyone. On the financials front, let me start with our cash position. We ended the year 2025 a strong cash position of approximately $713 and $13,400,000. 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. As a reminder, non-GAAP expenses exclude stock-based compensation expenses. Total GAAP operating expenses for 2025 were $225,000,000 compared to $234,200,000 for 2025.

This decrease in GAAP operating expenses was primarily due to the lower stock-based compensation expense of $19,100,000, and this was offset by an increase in our clinical trial-related spend of $8,800,000. Overall, our non-GAAP operating expenses during 2025 were $113,300,000 compared to $103,400,000 for 2025. This increase in non-GAAP operating expenses was primarily related to an increase in R&D expenses related to HARMONY-3 and HARMONY-7 trials. As you will note, we have been very and disciplined in controlling our G&A spend. Our total G&A spend, excluding stock-based compensation expense, has been a been approximately $43,000,000 for the full year 2025, with a run rate of approximately $10 to $11,000,000 per quarter in 2025.

On the operations front, I am 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 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 avanismap to a U.S.-based manufacturer. And with that, will hand it back over to Dave.

Dave Gancarz: 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.

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 1 on your telephone keypad. If you would like to withdraw your questions, simply press 1 again. We will take our first question from Salveen Richter at Goldman Sachs.

Dave Gancarz: 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 how many three for the squamous cohort and also frame expectations for both the initial data in the second quarter and also the potential final DFS analysis in the second half? 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 two of that analysis time? Thanks, Mark. Appreciate the question. This is Dave.

So we decided to amend the protocol for the HARMONY-3 study by including interim analysis for PFS endpoint. If you recall, we previously amended the HARMONY-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 HARMONY-2, which showed the large PFS delta that McKee spoke to has a ratio of 0.51, comparing Ivo to Monotherm and Tepembro, of lung cancer patients. And then this would allow for an so this was then seen again in the HARMONY-6 data.

So this would allow for an earlier discussion with the agency based on the PFS primary endpoint and now an interim PFS. So it is really about accelerating the timelines with respect to the data based on two interim readouts from our partners at AKSO in studies in lung cancer. And so with both studies, reading out positively, the overlap in the indication with respect to HARMONY-6, that gives a strong indication in terms of the opportunity that exists here with IVO chemo versus a PD-1 plus chemo here.

What I would say with respect to your question on survival, and I think McKee emphasized this point a minute ago as well, overall survival will be immature at the time of the interim PFS analysis. 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. And then with respect to your final question on final PFS interim OS, so that remains no real change in timing.

That is the second half of this year again. We are not really guiding and we do not really comment historically on our expectations with respect to results. We do not you know, we obviously are encouraged by ivenesumab’s phase two data that the phase three data that, took place, in HARMONY-6. And so we really, you know, are looking to continue to know, follow in those trends, but do not necessarily guide specifically with respect to our expectations numerically, if you will. Excellent. Thank you.

Operator: We will go next to Yigal Nochomovitz at Citi.

Dave Gancarz: Great. Thank you very, very much for taking the questions and for the comprehensive, update. Nike and team. So just to kind of press further on this question around this interim PFS and second quarter now. So it sounds like what you are saying is that, you know, 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-3, you know, with respect to an event rate? That is faster or other new piece of information that increased your confidence in doing this interim now in the second quarter?

Or is it is it really just a question of providing this update sooner to accelerate development, you know, based on, as you pointed out, what you what you saw with HARMONY-2 and HARMONY-6. Thank you. Yeah. Thanks, Yigal, for the question. It is really a data-backed decision, as we mentioned, with respect to interim readouts for HARMONY-2 and 6. And then, obviously, the significant overlap in setting with HARMONY-6. I would also reemphasize we are not changing the timing in terms of guiding towards final PFS expectations and then the interim OS, the node no change there from event. I will let Alan provide more commentary as well. Yeah, Yigal. I think what you said is the latter.

Remember, this study was designed way back in ’23. Right? And since then, we have had the HARMONY-2 and the HARMONY-6 readout. Our mission is always to bring this very important medicine, which we think is a game to patients as soon as possible.

Manmeet Soni: Right?

Dave Gancarz: And I think the HARMONY-2 and now the HARMONY-6 data gives us growing confidence. Now granted, both of those studies read out on an interim PFS, was very dramatic. And PFS is a surrogate endpoint, so there will have to be some regulatory discussion. But we will need to look at that data before we can make those decisions. But, again, I think this is an opportunity to bring patients faster. 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? No.

Not nothing in terms of a statistical plan at this point has been provided, neither for the interim PFS nor the final. But, you know, we have provided approximate sample sizes for both cohorts and then obviously the primary end of both PFS and OS. Okay. And then totally separate question. I just wanna, you know, comment or ask about alum Illumine. So is there you had the data in ESMO in 2024. Is what do you know about contribution of components with respect to Ivo and legifalumab?

Is there evidence to suggest synergy or not, or is this just an additive effect if you 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 and back in 2024. Sure, Igal. Thanks for the question. So if you recall from ESMO 2024, we showed data that was generated from our partners at Akeso both in monotherapy, ivanesimab, as well as ivanesimab in combination with ligapalumab that, as McKee explained, was Akisa’s proprietary CD47 antibody. In that data was encouraging in both cohorts, but it did show an additional uplift that was seen with ivonesumab plus lixocalimab.

And so we have seen our partners at AKSO launch a phase three study with the combination in PD-L1 positive head and neck cancer. And so, we have explored and have been encouraged by this data as it continues to the Phase II data continues to mature.

And part of the study being a three-arm study with Ivo in one arm, Ivo plus Ligufelumab in the second arm, and then the control arm being monotherapy pembro, 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 Gore Tech, and I would like to obviously, you know, thank GoreTech for, you know, their enthusiasm in terms of the study. And that is, you know, what is what is led to the progression here. Yeah.

I would just add that, you know, as Dave said, you called it, the, you know, the data from ESMO showed that the combination of ligofalumab and ivenesumab had no higher overall response rate than ivenesumab alone. We are excited to work with GoreTech, which is a premier cooperative group in head and neck cancers. And they have designed a very rigid, clinically sound, scientifically robust

Manmeet Soni: study.

Dave Gancarz: To demonstrate that. And I think the key comments in the script showed that there are going to be ivonesumab as one group, and ivanesimab plus legofalimab. So you can demonstrate the contribution components against the standard of care pembrolizumab. I think that is going to be very important.

Manmeet Soni: Thank you.

Dave Gancarz: Thank you.

Operator: Next, we will move to Brad Canino at Guggenheim.

Dave Gancarz: Hey. Afternoon. Congrats on the screening completion. For me, it is it is not quite clear yet why adding the interim provides a benefit with regulatory discussions because it seems like you will reach final PFS before any OS data, interim or final.

Brad Canino: And presumably, you would need the OS to file anyway. So can you help square that for me? I am sorry to beat the horse on this one.

Dave Gancarz: No.

Brad Canino: Great. Thanks for the question, Brad. And so I think there is a couple things in terms of what you said. So first of all, you cannot really have a discussion with respect to data with the regulatory agencies without data. Right? And so part of part of the interim analysis allows for the generation of primary endpoint based data. And then know, as we continue to mature, that data you will 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.

And so when you kind of combine those two points, it allows for acceleration of the conversation without much delay with respect to know, there is 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. And 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

Dave Gancarz: that frontline lung could see approvals with just PFS benefits and only OS trends. Thank you.

Brad Canino: Yeah. I mean, I think there are you know, depending on it is a combination. Right? It depends on the timing. Right? The magnitude of the benefit is important. And then, obviously, there will be some contribution in terms of you know, overall survival trends. And I think that is where we see dual primary endpoints in this study. And then across solid tumors you see that in several places as well.

Manmeet Soni: The studies, to be

Brad Canino: clear, are certainly powered for both primary endpoints, which is an important point as well. So, Brad, this is Amit. I think it is other words. Right?

Manmeet Soni: Depending upon this earlier interim PFS data and the magnitude of 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.

Dave Gancarz: Okay. You.

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

Dave Gancarz: Hi. This is Josh on for Cory Kasimov. Thanks for taking our question. Our question is on the head and neck Phase III. Why opt to go through a co-op group here? And what signal will you want to see before committing to expanding into the U.S. here, and could it be used to leverage for a U.S. approval?

Bradley Canino: Yeah. Hey, Josh. Thanks for the question. So a couple points there. I think one, we have we have talked a few times now in terms of expanding our phase three program more broadly. So I think in some ways, there is 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 is a highly competitive space in head and neck cancer, and we think there multiple opportunities for patients in this setting and we think ivonesumab presents a strong opportunity. In particular, ivenesumab then potentially ivenesumab in combination with legofelimab. Right?

And so working with cooperative groups also expands the number of trials that are able to be

Dave Gancarz: performed ultimately. And so it is important that we are

Bradley Canino: taking on as much opportunities as we can with respect to bringing ivenesumab to as broad of a set of patients who are impacted by cancer as we can. So we think that is a strong approach overall, it is a strong cooperative group who has run multiple studies as well, and they were highly enthusiastic based on the data that has been presented and obviously working with them since. And so, Mickey emphasized, earlier as well, it is important to note that we do plan to continue to expand that Phase III program in 2026.

And I think we have been pretty clear that as we plan to launch additional studies, we would wait until we get to the readiness to launch and we would have FPI insight. 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 and it was an opportunity to really explore on a multi-regional setting these two regimens, really the monotherapy as well as the combination regimen.

Dave Gancarz: Got it. Anything

Manmeet Soni: yeah. Go ahead. Sorry. I was just gonna add. They approached us.

Bradley Canino: Right? So they came to us. You know, head and neck is an unmet need. It is not the largest unmet need in the PD-1 VEGF space. And so I think we are gonna, as Dave said,

Dave Gancarz: focus our resources on the largest unmet needs, and this one was convenient because they came to us wanting to do a study. Yeah. Sorry, Josh. I interrupted you. Yeah. No. Thanks, Alan. I was gonna ask

Bradley Canino: if

Dave Gancarz: there was anything specific you could give us on what may trigger like, a U.S. expansion here?

Bradley Canino: Yeah. Not I do not know that at this time we wanna start disclosing specific details, but, obviously, we will get enthusiasm with respect to enrollment in several in Europe who are enrolling in the study, feedback from GoreTech as they operationalize the study. There is also additional data being generated by our partners Zitakezo in phase three in China with respect to this setting. So I think there is a multitude of different. And it is continuing maturity of the phase two, obviously, as well. So there is multiple paths with respect to that, but nothing more specific there, Rade, just at this point.

Dave Gancarz: Got it. Thank you.

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

Manmeet Soni: Hey, guys. Congrats on the squamous enrollment completion and the progress

Allen Yang: So should we expect the HARMONY-6 OS data later this year? And how about HARMONY-2 OS data as well? And in general, given the upcoming HARMONY-3 OS data over the next year, 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?

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

So I think the protocol for HARMONY-6 was published, and so that would appear at some point, you know, to look like, 2026 is an event that 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. So I would make a couple of points.

I do not think there is a better analogy in terms of opportunity with respect to a randomized phase three study, you know, and in this case in squamous non-small cell lung cancer, Ivo plus chemo versus PD-1 plus chemo, then a randomized phase three, you know, that was nearly identical 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, you know, reduction of risk and or death.

And so when we look at the translation from China to the global setting, we are obviously very confident in HARMONY helped enforce that with very consistent results with respect to OS, both from a medium perspective as well 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 is the confidence level translating that into OS? And so, at this point, four randomized phase threes have read out, right? HARMONY A was the first, and that was in China, second EGFR mutant non-small cell lung cancer after TKI. In that final OS analysis was statistically significant. And that was displayed at SITC.

The second was the HARMONY study, and we have talked at length there with a very strong showing with respect to overall survival. The final analysis was not statistically significant; with longer follow-up time given the given the delays in initial enrollment in the in the follow-up time differences between China the U.S., we saw a nominal p value that was below any threshold with respect to what would be required for significance. We saw a p value of 0.03. We look at HARMONY-2, the only readout we have seen thus far was the NMPA, the Chinese health authority requested look, and that showed a an OS hazard ratio of 0.777 comparing IBO to pembro.

So at this point, HARMONY-6 has not even hit that point and it is still that application is in review, as our partners at Acasso have announced, and so there has not been a look yet at overall survival. 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, that is kind of the generally agreed-upon threshold for clinical meaningfulness, if you will.

And so the amount of encouragement that we have seen with respect to OS is about as high as you can get with respect to the time that we are 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 have seen to date have pointed in one direction, which has been highly encouraging. So, hopefully Tyler, a comprehensive answer to your question, but you know, one that answers it

Dave Gancarz: And Tyler, this is Alan. I would just add from a clinical perspective, from the mechanics of the study, they are not a crossover design. The standard of care for both arms is the same. Right? And the patients are blinded, so they do not even know whether the 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, five months later,

Bradley Canino: because of the PFS benefit, phenol,

Dave Gancarz: that should translate to a benefit in OS. Right? It is just such a large magnitude in delaying that next line of therapy.

Allen Yang: That is great. Thanks.

Operator: And Asika, your line is open. Please go ahead.

Dave Gancarz: Hi, guys. Thanks for taking my questions.

Asthika Goonewardene: So I have got a question more of a commercial question here. So as you are thinking about the commercial footprint you are gonna need for EGFR mutant as well for lung that you plan that you are building up right now? Much of footprint could you would be usable for the broader for the broader greatest population. I am assuming all of that. But then how much more would you have to add on top of that to address the broadest squamous population? Then I have a follow-up.

Manmeet Soni: Hey, 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? And as you would know, right, most of them are treated by similar physicians over there. So, our footprint and synergies will come, right, pretty much EGFR is a much smaller population base. Squamous gets over, like, 2.5 to three times bigger than EGFR, and then nonsquamous comes, which is almost double of squamous. Right? So it keeps expanding, but it gets our foot into the door.

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 SQMS and non-SQMS. Because these are all similar physicians. Same institutions. So,

Asthika Goonewardene: so let me have how should we think about, I guess, the ramp up in your expenditure for the SG&A line item?

Manmeet Soni: Yeah. We have been, like, pretty efficient over there. I said, EGFR is the smallest one, right, to in each We do not have to put 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 lot of activities on the medical affairs front, which we initiated right last quarter, and those all are happening. So 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.

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

Asthika Goonewardene: Got it. Thanks for that. And then as we are I like that you guys are offsetting some of the development through these cooperative groups like Vortech. Of course, these groups are going off a data that is generated in China. Also with novel agents, that are not yet approved in the U.S. and Europe. So I guess how are you thinking about when you think about these data convert them for U.S. submissions. How are you thinking about some of the regulatory requirements like Project Optimus 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 are generating is gonna be applicable for a U.S. submission too.

Bradley Canino: Yeah. It is a great question, Astika. And so importantly, our partners at AKSO here have started a phase three in China in this setting. And so that also speaks to the additional data that exists with respect to some of the work that has been done in this setting. And also, there is there is optimist. There is there is contribution of components, which we spoke to earlier as well. And obviously, with the novel here with Ivo and Ligue, it is important to show Ivo is a monotherapy as well as Ivo and Ligu combined.

And so, I think a lot of the concepts that you are speaking to are something that is permeating both in the U.S. as well as Europe. The cooperative groups are very familiar with those thought processes of the health authorities. And so in general, that is not something that is of high concern in terms of pushback or anything like that with the with the cooperative groups. That is something that is pretty well understood at this point.

Dave Gancarz: Yeah. Hi, Ashtika. This is Al. I just add to what Dave said is that we have used Chinese data clearly, to satisfy Project Optimist before, so that should not be an issue.

Asthika Goonewardene: Got it. Thanks, guys.

Operator: We will take our next question from David Day at UBS.

Asthika Goonewardene: Great. Thanks for taking my questions. Just on the HARMONY

Dave Gancarz: I trial in second line EGFR and also for lung cancer, Let just could you provide some additional color on DFT interaction leading to the BLA submission? And then more importantly, anything to share on the FDA extent on the OS? How has that changed over time?

Allen Yang: Yeah. This is Alan Hing. So, again, I think we have been very transparent that

Dave Gancarz: you know, 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.

Allen Yang: And

Dave Gancarz: we said, look. We think the data are important. When we look at our data compared to other agents

Bradley Canino: approved in the space, we think that this satisfies an important unmet need for patients. And so we wanted them to review the full package of the data.

Dave Gancarz: We submitted it and they have accepted that filing and they are reviewing the data now. Got it. Okay. That is helpful. And then just on the most recent collaboration with GSK, the three ADC in combination with. So just maybe help us understand a little more on the initial indication you exploring. We know that the GSK is currently exploring the m h three for small cell lung cancer. Is that an indication you think will make sense for you to explore in combination with Ivo?

Bradley Canino: Yeah. We have specifically talked about in our press release announcing the collaboration small cell lung cancer. Right? And so that is a place. We have also been clear also that there is multiple solid tumor settings where we believe both B7-H3 as well as Ivo have shown promise.

And so but there is obviously a place where with the evolving landscape of small cell lung cancer, that is an important place for us to explore and we think the B7-H3 ADC, the GSK has is a is, you know, very much showing a lot of the we are not gonna go into details with respect to the comparisons we have done against the d seven h threes across multiple companies. But it is important that we, you know, we did look at that asset and feel that was a very appropriate partner for IVO with respect to collaborating in small cell as well as, you know, a couple other solid tumor settings.

Dave Gancarz: Thank you so much.

Operator: And we will move next to Mitchell Kapoor at H.C. Wainwright.

Allen Yang: Hey, everyone. Thanks for taking the questions. With HARMONY under consideration from the FDA,

Bradley Canino: could you walk through your high level

Dave Gancarz: thoughts on pricing strategy given the competitive landscape in EGFR non-small cell lung cancer, but also the benefit of ivanesemab, what it could provide in future expansion indications.

Manmeet Soni: Hey, Mitchell. This is Manmeet, and it is 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. And then, obviously, EGFR is our first one. But 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. You could see that there is big range, and we have the potential based on the benefit of having a snap to price it very well. But as you also stated, right, in the long run, we have multiple more indications to come.

We will have to price it appropriately. But more to come, I think there is no decision or nothing to add over here right now.

Dave Gancarz: Okay. Fair enough. And then on those potential expansion opportunities, ivonesumab is kind of this pipeline-in-a-drug opportunity, which is rare these days. But what kind of gating items, you know, would be there to determine how fast you could initiate more trials? Is it additional partnerships? Or anything that could determine, you know, the next steps you take? Are you watching Atesos?

Bradley Canino: Next moves, or, you know, what is helping you decide how fast to initiate additional studies? It is a great question, Mitchell. I think so is I want to emphasize one of the points that McKee spoke to because I think sometimes it you know, there is a lot of really positive events that take place with Ivo, and sometimes it is important to slow down on a couple. And so over 4,000 patients have been treated with ibanesumab just in clinical trial clinical trials sponsored by either Summit or Jessup. Right? So this does not include over a 140 total clinical trials listed on clintrials.gov at this point. This does not include, you know, as ISTs and whatnot.

But when we look at the amount of data generated by ivonesumab, there is a significant amount of information that can be really well understood in several different settings. We have also it is important that our partners at Akeso have initiated 10 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 ibansumab can be successful. And then, obviously, there is also a significant 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 U.S. and vice versa, right?

But there is a lot of overlaps with respect to the characteristics of those diseases that is important for us to be able to kind of translate that information across. But because there is so much patient data with respect to how patients have performed on ipanisumab, that really allows us to triangulate, if you will, the information. So we are not running, you know, hey, we you know, we have we have been able to dose 30, 40, 50 patients with IVO and now it is it is very encouraging. So we trying to figure out how to move forward.

There is a plethora of information and data, you know, so much of it 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 standard of care. It is 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? How is that evolving by the end of what would be a phase three clinical study?

And so we can really look at information we have internally, what is happening in the market, to really at the end of the day, we are trying to do is provide a medicine that improves outcomes for patients. Right? But that takes an ecosystem in order to do. Physicians need to be able to access, understand, and have clear answers from that data. 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 many of the tumor types that are sensitive either to immunotherapy anti-angiogenic therapy, places where neither have been successful but there is an with ipanisumab, 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. And that is why some of these even collaborative studies or collaboration opportunities rather with ResMed, with GSK, that is important, we will have more of those coming as well.

But when we look at the totality of what is out there, it is really important to consider each of those points. And so that is why we really look to expand much further in 2026 as well.

Dave Gancarz: Yeah, Mitch. And I want to just address a couple of your comments. So you know, at JPM, McKee announced that we are gonna be doing multiple new phase three programs. We will, of course, continue to explore cooperative groups

Bradley Canino: studies, and collaborations with partners, and you should expect more of those to come. But our strategy is not dependent on that. We will have sponsored studies based on the AKSO data and

Dave Gancarz: moving forward. And so you should expect more of those studies to come as well. Wonderful. Thank you, guys.

Operator: Next, we will go to Eric Schmidt at Cantor. Thanks for taking my question. I wanted to go back to

Dave Gancarz: HARMONY-3 and beat the horse a little bit more. I am wondering if you have 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.

Bradley Canino: And, Eric, you are just to be clear, Eric, you are speaking about the interim

Asthika Goonewardene: PFS?

Manmeet Soni: I am. Thank you, Dave. Yep.

Bradley Canino: Yeah. No. I appreciate it, Eric. So, I mean, look, I think and I think we kind of mutually address this across comments from Manmeet, McKee, and myself a little bit earlier. But it is important that the analysis is run and then we see the analysis in terms of outcomes, in terms of what the next, you know, logical steps are in that respect. And so and then, obviously, positive data, you know, requires, you know, contemplation with respect to major medical conferences as well. And so it is we have know, several we are, 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 will be providing, you know, a little bit more clarity on what that looks like. Obviously, we thought it was very important now to provide effectively an immediate answer with respect to the analysis being 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.

Dave Gancarz: Yeah. Okay. And then Go ahead. I just want to manage it expectations here. 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? And as a courtesy to them, we need to demonstrate to them first. Right? Then in collaboration with our investigators, we want to present this at a major medical meeting. So, you know, unfortunately,

Bradley Canino: you know, sort of

Allen Yang: a press release with curves for you guys as investors and analysts are not gonna be a high priority for us.

Dave Gancarz: Well, I guess 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 a interim PFS readout, that would be too great a disclosure making regulators too uncomfortable. But do you have a view on that?

Bradley Canino: Sorry, Eric. I am not I am not sure we followed exactly what your arrangement. I think what he is saying is

Dave Gancarz: Eric, correct me if I am wrong, but what you are saying is if we were to release top-line interim PFS, would that impact the study scientifically in terms of unwinding it for the final PFS? Right? Exactly. Thank you. Yeah. I understand what you are saying. And I guess I just do not wanna disclose too much about what we are doing.

Manmeet Soni: At this time.

Dave Gancarz: I understand your question. We are, of course, gonna take that into consideration. But, you know, I just do not wanna disclose how we are gonna do this right now.

Bradley Canino: Yeah. I would say a couple of key principles. Right? We are we are never gonna do anything that puts at risk the, you know, the final analysis, if you will. And I think it part of this becomes an outcomes-driven response as well in terms of 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.

Dave Gancarz: Okay. Thanks, guys. Appreciate all the updates.

Operator: And we have time for one more question. And we will take that question from Faisal Khorshi at Jefferies. Hi. Thank you guys for taking the question. I wanted to ask on the

Dave Gancarz: FDA review for HARMONY. Have you guys had any interaction with the FDA since having the BLA submitted?

Asthika Goonewardene: And is there anything in FDA’s stance changing on acceptability of PFS and read through of that to HARMONY-3.

Bradley Canino: Yeah. Thanks, Faiza. I think we addressed most of this a little bit earlier, but to yes. We have interactions with the agency. We do not necessarily disclose, you know, you know, meeting by meeting discussions and whatnot. And so what we do not want to do is we are we are not looking to leverage external sources in terms of, you know, pressuring the or anything like that. We have we have confidence. Those discussions are intended to be confidential.

So we are not we are not necessarily giving step-by-step updates with respect to that, but we have inter we do have interactions with the agency both for this study as well as, you know, other current studies and then, know, potential future studies. And so it is important in terms of the totality of what we are looking to accomplish with ibenzumab that we have a we have the utmost respect for the FDA. I think that is a just a level-setting point.

That becomes very important in terms of, you know, with the platform opportunity, if you will, for iVotes, there is a lot of studies with a lot of potential settings where ivanesumab 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 ivonesumab to be to as many patients facing an unmet need as possible. In doing what is right for ultimately patients facing cancer diagnosis.

Asthika Goonewardene: Understood. Thank you.

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

Bob Duggan: Not only is David correct in saying that we have 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 are really honored reporting into them. Lastly, we are also very impressed with our partner Kesso. You know, Kesso has almost a few $100,000,000 of investment value in their ownership along with you all that are owners of Summit. And we are happy that they chose to do that. We are also quite pleased to see that time after time when they introduce new drugs they get through their own agency, they get clearances, they are doing quite well.

If there is any China lookalike Regeneron, it is it is some it is a Kesso. Just a fabulous company with great engineers, great scientists, and we are pleased that they are the source of the bispecific tetravalent back in 2013. And yeah, we are we are proud to have that in licensed. And we are we are making great progress with that. So you all. We look forward to updating you on our next call. Unless there is great late-breaking news in between.

Bradley Canino: Thank you, everyone.

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

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