Coherus Oncology, Inc. Q3 FY2025 Earnings Call

Good day, and thank you for standing by. Welcome to the Coherus Oncology Q3 2025 Earnings Conference Call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Carrie Graham. Please go ahead.

Thank you, Heidi. Good afternoon, and welcome to Coherus Oncology's Third Quarter 2025 Earnings Conference Call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus; Bryan McMichael, Chief Financial Officer; Dr. Rosh Dias, Chief Medical Officer; Dr. Theresa Lavallee, Chief Scientific and Development Officer; and Sameer Goregaoker, Chief Commercial Officer. Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coherus' current expectations about future events. Actual results may vary significantly, and we undertake no duty to update or revise any forward-looking statements. Please see the press release that we issued today and our quarterly report on Form 10-Q for more information on risks and uncertainties.

Thank you, Carrie, and good afternoon, everyone, and welcome to our Q3 2025 earnings call. As we get started, let me first welcome Arvind Sood to Coherus Oncology, our newly appointed Chief Strategy and Corporate Affairs Officer. Arvind is responsible for Investor Relations, Corporate Development and government affairs. Welcome, Arvind. Things are going very well and today, I'm very excited to tell you about the progress we have made on our strategic plan in the last quarter, as well as generally recap our progress for you over the past year as we approach the end of 2025. As you know, we take great pride in our ability to execute, and execution has been strong across the board. For example, you may recall last year me telling you that our objectives included driving the top line, reducing expenses and strengthening the balance sheet. I'm happy to report that we've made great progress across all 3. We are particularly pleased with our progress on the balance sheet and expenses, which shows a substantial improvement over the past year. My Chief Financial Officer, Bryan McMichael, will discuss these results with you directly. Now the Coherus Oncology value proposition for investors is all about our drugs, our evolving data and the opportunity for deals. We have set ourselves up for success with a sound strategy and have gained significant momentum and hit our stride. Regarding our drugs, LOQTORZI is a next-generation PD-1, active in low PD-L1 cancers and approved in nasopharyngeal cancer, where it is a revenue generator for us, providing growing sales and margin contribution. Our Chief Commercial Officer, Sameer Goregaoker, will give you the color and detail on that shortly and reiterate our confidence that we will achieve our revenue targets. Our focus as a cancer company is achieving a step change in patient survival. That is our goal. We believe the future of extending patient survival lies in combinations, and we are combining LOQTORZI with both our own proprietary pipeline assets across indications. LOQTORZI is also being used in combination with other companies' therapeutic assets. And upon approval of any of these drugs, will be a revenue multiplier, its second key role in our strategy. We are currently pursuing liver and lung cancer with casdozokitug. And with CHS-114, our CCR8 Treg depleter, we are pursuing head and neck cancer, gastric cancer, esophageal and now colorectal cancer, an area of expanded focus for us, all in combination with LOQTORZI, which brings me to the second thing for investors to keep in mind, our data. In just a moment, Dr. Rosh Dias, our Chief Medical Officer, will update you on our enrollment and clinical trial progress in more detail. But I will note here that enrollment across all of the initiated studies is in full swing and on a global basis, with the vast majority of our sites open as we drive to deliver data for you next year in these promising indications. With clinical development, we have hit our stride and with highly engaged clinical investigators enthusiastic about these highly promising mechanisms of action and enrolling their patients suffering from their unmet need to stop their cancers. Dr. Theresa Lavallee, our Chief Scientific and Development Officer, will spend a few minutes with you today discussing the mechanism of action of our drugs with particular focus on the therapeutic promise of T regulatory cells as a target. As you know, this field was the subject of a recent Nobel Prize in Physiology or Medicine, thrusting it to the fore and underscoring its therapeutic potential. As a leader in this rapidly advancing field, Coherus Oncology is proud to be the first company to demonstrate Treg depletion and subsequent CD8-positive T cell infiltration in a patient. The organizers of the 2025 SITC meeting invited us to present our data at a webinar recently, which was the highest attended of the year. CHS-114, our highly selective CCR8 Treg depleter, is potentially best-in-class. And given the broad distribution and role of Tregs in the body, selectivity takes out a dominant role. With our broad yet focused clinical program reading out over 2026, we are well positioned to continue the scientific leadership that we demonstrated in 2025. We have global rights to CHS-114, as well as casdozokitug. So let me make a few comments about potential deals, the third part of our value proposition investors should keep in mind. Treg depletion is potentially complementary, mechanistically with a wide variety of existing therapeutics where the proportion and density of T regulatory cells is correlated to poor outcomes. Recall my earlier comments about combinations. This means that adding something like CHS-114 to ADCs, bispecifics or radiation treatment or other therapeutic approaches may improve outcomes and extend survival. We are pursuing such partnering opportunities both in the U.S. where we are commercially focused, but also globally ex U.S., where we are not focused yet have full rights. Such arrangements will provide us with income from upfronts to offset ongoing clinical development costs, but more importantly, cost contribution to pivotal or registrational trials, which need to be conducted globally. Over the next 6, 12 and 18 months, we can expect our emerging clinical data to drive such deals, and we'll keep you updated on our calls. And with that, let me hand it over to Theresa.

Thank you, Denny, and good afternoon. I'm excited to update you on Coherus Oncology's innovative pipeline aimed to advance cancer treatment. Let me start with this year's Nobel Prize for physiology or medicine, recognizing the importance of T regulatory cells and immune homeostasis. If Tregs are defective or missing, this results in severe autoimmune disease, providing strong evidence for the critical role these cells play in peripheral immune tolerance. Tumors exploit these cells as a key mechanism to evade the immune system. This is a problem because it results in cancer growth and progression. The presence of Tregs in tumors is known to be associated with poor outcomes to any cancer therapy, including chemotherapy, radiation and of course, PD-1 inhibitors. While this is well known, what has been a problem in the field is a way to selectively target Tregs in the tumor and not in peripheral tissue. CCR8 is a protein preferentially expressed on tumor-resident Tregs, enabling a targeted therapy approach to selectively remove these immune suppressive in the tumor. We have been focused on CCR8 as a drug target for several years and believe our program is set apart from the field. CHS-114 is a cytolytic antibody with ADCC enhancement designed to find and kill CCR8-positive Tregs. This mechanism is akin to an ADC molecule. And in this case, the payload is enhanced effector function leading to Treg killing. Our preclinical and clinical data have shown differentiation, potency and tumor response. CHS-114 was evaluated for binding to over 5,000 human proteins, the entire proteome available on the outside of the cell. Importantly, CHS-114 only binds to one protein, its target, CCR8. Eliminating off-target binding has the potential to have a differentiated safety profile. CHS-114 is the only known selective CCR8 antibody. Additionally, it has shown an acceptable safety profile, selective CCR8 Treg depletion in tumors and also a remarkable ability to lead to the increase of CD8 T cells in tumors, thus characterizing the tumors as hot or immunologically responsive. In the initial safety cohort of 7 U.S. patients evaluating CHS-114 with toripalimab, a response was observed in a fourth-line head and neck cancer patient. All of these data not only show the idea works, targeting CCR8 will mainly remove tumor Tregs, but also show CHS-114 treatment remodels the tumor to be more immune active. This weekend at the Annual SITC conference, we will present additional biomarker data showing significantly enhanced immune activations in head and neck cancer patients following CHS-114 treatment with toripalimab. This is important as we are testing whether the combinations of CHS-114 with toripalimab can overcome PD-1 resistance in refractory patients. CHS-114's pharmacological and clinical attributes establish it as having good drug-like properties. And this, coupled with our program's focus on generating data to address 2 areas of increased scrutiny by the U.S. FDA. First, data in a Western population; and second, dose optimization, establish our scientific leadership in the space. The last point I want to make on CHS-114 is that it is a targeted therapy. So, we know who to treat, essentially tumors with a high prevalence of CCR8, its target. Tumor types that have a high degree of CCR8 include lung, colon, head and neck and gastric to name a few. Coherus Oncology is prioritizing some of these tumor types and is now enrolling in a new cohort evaluating CHS-114 and toripalimab in a patient population without any approved immunotherapy yet, microsatellite stable colorectal cancer. The clinical program is designed to generate data on a variety of solid tumors and further inform where CHS-114 and toripalimab treatment results in meaningful clinical benefit alone or in combination with chemotherapy. Now switching gears to discuss our other promising clinical program, casdozokitug. Another approach to overcoming immune evasion is activating NK cells. T cells and NK cells are the body's immune killer cells. Casdozokitug, Coherus Oncology's first-in-class IL-27 antagonist results in immune activation of both T and NK cells. At this week's International Cytokine and Interferon Society meeting, we presented preclinical and clinical biomarker data showing an important role for NK cell activation and casdozokitug's efficacy, particularly in first-line HCC, a tumor type rich with NK cells. The updated biomarker data continue to support that casdozokitug treatment leads to inhibition of IL-27 signaling and enhanced cytolytic immune activity by NK and T cells. Why is this important? Two reasons. One, casdozokitug treatment results in strong NK cell activation may give a mechanistic explanation for why the results showed a more than doubling of the complete response rate, activating both NK and T cells could optimize tumor cell killing and lead to its disappearance. The second reason I highlight this is that when a new drug is added to standard of care, we need to show the contribution of components or said plainly, is casdozokitug adding anything to standard of care. These data give further confidence the deepening of response is associated with casdozokitug treatment since patients who respond show IL-27 inhibition and significant NK cell activation. Also, I want to reiterate Dennis's comments that identifying partnerships that accelerate the development of the pipeline is a priority. We own global rights for both casdozokitug and CHS-114, and these compelling clinical data across the 2 pipeline assets are supporting discussions with potential partners. Before I turn it over to Dosh, let me just summarize why we are excited about recent developments with our key pipeline molecules. We were thrilled the Nobel Prize for Physiology or Medicine recognizes the importance of T regulatory cells in immune homeostasis. We will present biomarker data at the SITC meeting this week, showing enhanced immune activation in head and neck cancer patients following treatment with CHS-114 in combination with toripalimab. Also, our presentation of biomarker data earlier this week at the International Cytokine Meeting provides further support of casdozokitug's contribution on top of standard of care in liver cancer patients. With that, I'll turn it over to Dr. Dias, who will further describe the clinical development.

Thank you, Theresa, and good afternoon, everyone. Given the clear unmet medical need and the potential for improvement over existing therapies, we are actively progressing our programs for both casdozokitug and CHS-114 in specific indications. Investigators around the world are highly engaged and enthusiastic about our programs, with significant participation in our trials. Starting with casdozo in first-line hepatocellular carcinoma, we are conducting a 3-arm multinational study that randomizes patients to two doses of casdozo in combination with toripalimab and bevacizumab versus the tori/beva combination. This study is designed to achieve three objectives: firstly, to gather efficacy and safety data; secondly, to address the FDA's Project Optimus; and thirdly, to evaluate the contribution of the components as we move through the development process. This trial builds on the encouraging data we presented at ASCO GI in January. In Study 201, we demonstrated that casdozo combined with atezo and bev achieved an overall response rate of 38% and a complete response rate of 17%, representing both an improvement in overall response rate and a deepening of responses compared to initial data from the same trial, which shows favorable comparison to historical benchmarks of 30% and 8% for overall and complete response rates with atezolizumab. With these promising results, global investigator sentiment has been very positive about the potential of the casdozo, tori/bev combination. The trial is recruiting as planned, and we are optimistic about delivering early efficacy and safety data in the first half of 2026. Now, regarding CHS-114, our CCR8-targeting cytolytic antibody, it has potential applications across various tumor types, and we have a strategic focus on four specific tumors where there is solid biological and clinical rationale for evaluation. First, in second-line head and neck squamous cell carcinoma, we reported earlier this year at AACR a partial response with significant tumor shrinkage in a fourth-line patient who was refractory to several prior therapies, including a PD-1, a TKI, and a taxane. We were invited to present this data again during the highly attended SITC seminar a few weeks ago. We are on track with our ongoing study involving two doses of CHS-114 in combination with toripalimab in the second-line head and neck squamous cell population previously treated with PD-1 therapy, aiming to report efficacy and safety data in the first half of 2026. This data will help us understand the role of CCR8 as a resistance mechanism in this specific patient population. Second, in second-line upper GI adenocarcinoma, we are exploring two doses of CHS-114 in combination with toripalimab in patients who have received one prior line of therapy. In this indication, proof of mechanism has already been established for the CCR8 class in combination with toripalimab. We are recruiting as planned and expect to report efficacy data in the second half of 2026. Third, we are pursuing esophageal squamous cell carcinoma, capitalizing on the activity of toripalimab regardless of PD-L1 levels, and we are evaluating both first-line and second-line treatments where the medical need is significant. In the second-line population, we are conducting limited dose expansion of CHS-114 in combination with toripalimab, and our first-line cohort is focused on safety data for CHS-114 combined with toripalimab and standard chemotherapy. We are also on track to report efficacy data in the second half of 2026. Finally, we have expanded the CHS-114 program to include a colorectal carcinoma arm. This tumor type presents a significant unmet medical need, and there is strong biological rationale due to the elevated levels of CCR8-positive Tregs in colorectal cancer. Our approach will first explore the combination of CHS-114 and toripalimab in the fourth-line plus MSS population, where current standard care provides a low overall response rate and patients require more treatment options. Our trial will initially investigate the combination in patients without liver metastases and will quickly advance to those with liver metastases, who historically respond less well to existing treatments. We are excited about the progress with our clinical programs as we strive to provide superior alternatives for cancer patients in need, and we look forward to presenting multiple data updates in 2026. Now, I will hand it over to Sameer.

Thank you, Rosh. Today, I will focus my discussion on 3 areas. First, I'll cover LOQTROZI Q3 business performance. I will then discuss the evolving market dynamics, specifically in the community versus the academic setting. And third, I'll outline our plans for driving continued growth in the coming quarters. Q3 LOQTORZI net revenue grew to $11.2 million, a 12% increase quarter-over-quarter and a 92% increase year-over-year. However, this is down from the 35% growth that we saw in Q2. So, I'll offer some perspective and context. Growth in Q2 included inventory accumulation as a result of previously depleted inventory levels. So, demand growth was actually about 20% in that quarter. In contrast, inventory levels remained flat in Q3, so almost all of our growth came from end customer demand. I'll point out that our sales team has 4 regions across the country. For this quarter, the average growth for 3 out of the 4 regions was 21%, close to the Q2 results. However, demand in the fourth region was flat, driven by post-restructure vacancies, which resulted in a lower share of voice impacting the overall national average. This issue has now been addressed, and I'll explain in a moment why consistent message reinforcement is critical across our customer base and how we're addressing it. Growth this quarter was driven by new patient starts in both new and existing accounts and increasing duration of treatment. The total number of accounts purchasing LOQTORZI grew over 15%, indicating increasing breadth of use. Additionally, 30% of existing accounts are now using LOQTORZI in a subsequent patient, indicating strong physician satisfaction. Longer-term, we expect to achieve a dominant share in the NPC market, which is estimated to be in the range of $150 million to $200 million. This translates into an expected average 10% to 15% demand growth over the next 3 years, which puts us on track to achieving our long-term goals. Transitioning now to market dynamics. As you know, there are approximately 2,000 LOQTORZI eligible patients each year. These patients are seen by both hospital-based head and neck specialists as well as community physicians. However, there are key differences in these 2 segments that we have to keep in mind to achieve a dominant share in both. First, hospital-based head and neck specialists see several NPC patients each year and are well informed on the NCCN guidelines and our clinical data. In this setting, we are seeing strong LOQTORZI growth, both in NCCN institutions and other large hospital systems. Accordingly, we are now shifting our focus from brand awareness to new patient identification and generating advocacy from academic KOLs. However, in our second segment, the community, the dynamics are very different. This is primarily because community physicians manage multiple tumor types constantly and NPC being rare is not always top of mind. The addressable opportunity in the community is very widely spread and physicians typically only see 1 to 2 new NPC patients each year. As a result, awareness of our preferred position in the NCCN guidelines and our clinical superiority data is relatively low. So, chemo alone or off-label IO continue to persist. So, the task in front of us is very clear. We have to consistently reinforce our clinical story in the community. But with a smaller sales force post divestiture, our reach and share of voice has been limited, particularly as we saw in this quarter's lagging region. With that background, let me now describe to you our 3-point plan to drive growth in the community. First, we're expanding our sales force by approximately 15% to increase our reach in select geographies. This is a very targeted expansion that we believe is financially responsible and will drive a positive ROI. Second, we're onboarding a remote sales team to drive engagement with oncologists that are not being reached by a sales representative. Covering these physicians in a cost-effective manner will expand our reach deeper into the community. And thirdly, we're significantly expanding our multichannel capabilities to educate community physicians. Specifically, we're developing a campaign of highly engaging KOL-driven digital programs. These will be distributed by our field team, our website, and third-party distributors. In summary, we see significant growth opportunities for LOQTORZI in the coming quarters. In recently conducted promotional effectiveness research, physicians stated strong resonance with our overall survival messaging and the NCCN guidelines. We remain confident that our focused execution will drive strong demand growth, and we are on track to achieving our long-term commercial objectives. With that, I'll now pass the call to Bryan McMichael, our Chief Financial Officer.

Thank you, Sameer, and good afternoon, everyone. After over a year of deal activity, the third quarter of 2025 was the first complete quarter following our exit from the biosimilar business. We used the proceeds from the divestiture to eliminate all near-term debt, transitioning into a company focused solely on innovative oncology. Today, I will provide key insights about the company’s status at the end of Q3 as we approach year-end and the data readouts for next year. We have significantly strengthened our balance sheet compared to the end of last year. By the end of Q3, our total cash and investments amounted to $192 million. Of the $429 million in total liabilities on our balance sheet at the end of the quarter, over half, or $254 million, was related to transition service agreements. These liabilities will be paid off using reimbursements from buyers in the divestitures or cash collected from their customers. The remaining portion of liabilities decreased by 69% since the end of last year. By the close of Q3, we have successfully organized or closed down most of the UDENYCA-related operations, allowing Coherus to concentrate on our priories laid out by Denny, specifically growing LOQTORZI sales and advancing our pipeline. We are aiming for a workforce of fewer than 140 FTEs by around year-end, adjusted from the earlier target of 150 FTEs. I will limit my discussion of the results to key updates; detailed quarterly results and figures can be found in our earnings press release. As Sameer discussed, increased volumes of LOQTORZI led to a rise in net revenues from continuing operations both for the quarter and year-to-date. Our continuing operations are showing strong execution of our strategy, starting with operational expenses. R&D expenses for the quarter were $27.3 million, a 24% increase from Q3 last year due to pipeline investments, slightly offset by savings from deprioritized programs last year. SG&A expenses were $24.9 million for the quarter, down 11% compared to last year, primarily due to reduced headcount. These figures pertain only to continuing operations. Total operational expenses for discontinued operations, covering the biosimilar business, fell to less than $1 million in Q3 2025. To provide context regarding the savings from divestitures, operational expenses for discontinued operations for FY 2024 exceeded $40 million. For the entire year of 2025, we are reiterating our projection that SG&A expenses for continuing operations will range between $90 million and $100 million. This estimate accounts solely for Coherus programs and excludes unreimbursed transition service agreement costs and asset impairment charges. Before returning the call to Denny, let me summarize the advancements we have made since transforming Coherus into the innovative oncology company it is today. There are three key points to remember. First, we have enhanced our balance sheet by significantly reducing our liabilities while maintaining enough cash to support operations through 2026, beyond key data readouts next year. Second, we are increasing LOQTORZI sales by strategically investing in our commercial infrastructure to spur growth in the upcoming quarters and years. Third, we are practicing spending discipline by streamlining our operations, reducing SG&A expenses, and focusing our investments in R&D on our pipeline molecule, CHS-114, and casdozokitug. With that, I will hand the call back to Denny.

Thank you, Bryan. So let me summarize our progress this quarter for you and the momentum we are carrying into Q4 and why we're so excited. First, strong execution across the board in all critical dimensions of the business and disciplines. On the financial front, we drove the top line with higher sales of LOQTORZI while reducing the overall expenses and strengthening the balance sheet, as Bryan just talked about. We advanced the pipeline, as Raj talked about. As clinical trials combining LOQTORZI with our own proprietary assets continue to progress, we prepare to turn over key data cards next year on more than a half dozen studies. Importantly, having full global rights to our pipeline products at this point in the company's evolution enables partnering opportunities outside the U.S., which will serve as currency to offset ongoing clinical development costs all the way through approval. Lastly, let me just take a moment to thank all of our dedicated team members here at Coherus Oncology for their extraordinary commitment to the company and their high performance, as we work to create value for patients and for shareholders. Heidi, we're ready for the questions.

We will take our first question, the first question comes from the line of Mike Nedelcovych from TD Cowen.

I have one, and it's more of an R&D type question. It seems like the CCR8 mechanism would be complemented not just by anti-PD-1, but potentially both targets on the same molecule in a bispecific format. I'm curious if that makes biologic sense. And if so, if you've explored that option at all?

Mike, thanks for the question. Dr. Lavallee would be happy to give you a little further insight on that. Theresa?

Just to clarify, do you mean to make a molecule that targets CCR8 plus something else?

That's right. Yes, and potentially anti-PD-1 or the older.

Yes. The challenge here is that while people are focused on bispecifics, the mechanism involves binding and killing Treg cells, which complicates the inhibition of PD-1 on cytotoxic T cells. There are developers working on bispecifics targeting CTRE, but what seems really promising with CHS-114 is not only the significant depletion of the immunosuppressive Tregs in the tumor but also the recruitment of CD8s. Therefore, a more traditional combination therapy approach that explores other immune activation methods could likely yield a stronger clinical response, based on scientific hypothesis. However, there are also other researchers examining CCR8 bispecifics, so we will need to keep an eye on those data.

We will take our next question, and the question comes from the line of Brian Cheng from JPMorgan.

First, can you share your thoughts on LAQTORZI's current trajectory? When do you anticipate the next major inflection point, considering your peak sales goal of $150 million to $200 million by mid-2028? How do you envision that trajectory? What do you see as the main barriers today? I also have a quick follow-up.

Thank you for the question, Brian. I'll address that first, then we'll move on to your follow-up. Sameer pointed out that if we project a growth rate of 10% to 15% per quarter from where we are now, we could reach our target of approximately $150 million to $200 million by mid-2028. However, there are two important points to note from Sameer's comments. Firstly, we experienced actual demand growth of around 20% in Q2, although the growth from Q1 to Q2 was about 36%, with the remainder attributed to inventory. In Q3, compared to Q2, three of our four regions averaged a 21% increase in growth, indicating strong performance for two consecutive quarters at around 20%. There was one region that fell behind due to staffing and turnover challenges in Q3, but we believe we have a good understanding of that situation. If we continue at this 20% growth rate per quarter, we would reach our $150 million to $200 million target much sooner than mid-2028. This shows we're actually exceeding expectations at the moment. However, it's hard to pinpoint exactly when that growth curve will take off. Additionally, Sameer provided clear guidance on his strategy to achieve this goal, emphasizing that the conversion of the community relies heavily on educating them. We’ve found that once physicians see the clinical data demonstrating the significant benefits of LOQTORZI for patient survival, they are easily convinced. Thus, it largely comes down to our outreach and converting physicians. Once they use LOQTORZI, they tend to continue using it for follow-up patients.

Yes. Regarding colorectal cancer, I'm interested in your thoughts on the benchmarks as we look ahead to the data next year. The fourth-line setting is quite advanced. How should we assess the benchmarks for success in this area? Additionally, looking at 114 from a broader perspective, there are several upcoming data releases across various indications. Do you have any insight on how you plan to prioritize these indications, given the numerous data readouts on the way?

Let me start by handing this over to Dr. Dias. First, we believe that the recognition of T regulatory cells with the Nobel Prize in physiology and medicine is significant. Our goal is to demonstrate scientific leadership and stay at the cutting edge of this field, which we have accomplished. I want to emphasize our previous comments in relation to the SITC webinar featuring Dr. Dias. We felt it was necessary to focus on colorectal cancer, where first-line treatment has been chemotherapy for the past two decades. This disease is increasingly affecting younger patients and is critically important. We truly believe it deserves a comprehensive investigation. Rosh, would you like to share your thoughts on the specific questions regarding colorectal?

Certainly, Brian. Regarding your first question about benchmarks for colorectal, I’d like to highlight a few points. Colorectal cancer, as Denny pointed out, is a significant and expanding area, especially among younger patients. Right now, there is considerable opportunity for improving patient care in this field. The response rate for the fourth-line and beyond population is currently in the mid-single digits, and the standard treatment is chemotherapy, which also has an overall response rate of around 5% to 6%. We aim to exceed that response rate while also focusing on durability and disease stability, among other factors, as we evaluate the overall evidence. I’m very enthusiastic about the potential of the Tori-CCR8 combination in late-line treatments, and we plan to advance to earlier treatment lines afterward.

Brian, regarding how we prioritize these indications, I'll let my team members add their input. We believe there is strong clinical justification and supporting mechanisms for all of these. We can identify where Tregs are a challenge, and those are the cancers we are targeting. For gastric cancer, there has historically been demonstrated efficacy with toripalimab from other research. We believe this indication has a high likelihood of success and is quite significant. In the case of esophageal cancer, toripalimab has shown efficacy in low PD-L1 states and is already approved in Europe. While it may not be a large indication, we are eager to explore it further. As for head and neck cancer, you are likely aware of the data we've presented, which indicates a partial response and other promising results. We are optimistic about these areas. Additionally, we might investigate further indications with our CHS-114, but currently, we have some very promising indications. Theresa, do you have any additional thoughts on indication selection or what we might pursue next?

Yes, I mean I think that we've characterized a large number of solid tumors that have a high density and prevalence of CCR8-positive Tregs. I mean, so tumor types that we're currently not seeing that would be of interest, and there's been some hints of efficacy in competitor programs or lung cancer, breast cancer, we saw data at ASCO this year in pancreatic cancer. Our program is really designed to inform us of the best setting where we see the largest effect. So, is it the density of CCR8-positive Tregs, is it the percent of CCR8 positive Tregs? Or is it the ratio with the T cells? So, our program is really designed next year to read out some important information on how best to look at ways to do quick development and then development to get in combination with other agents to get broader efficacy across multiple tumor types.

I would just add that our program, we believe, is both broad sufficiently across many of these indications, but also highly targeted, right? And so, I think that's really, in the end, going to be very beneficial for us.

Looking forward to the data next year.

Yes. So for casdozokitug, what would we need to see from the Phase II to justify moving straight into a pivotal study?

Thanks for the question, Jason. Dr. Dias, would you like to talk about that?

Yes, absolutely. Thanks, Jason, for the question. So, one thing that's really important to realize, and I referenced this earlier, is that we really look at the totality of evidence, not any one single measure. We are hugely encouraged by the atezo-bev/casdozo data that we presented earlier this year. I'll remind you again that what we saw was initial results and then an increase in response rate and a deepening of the response over time. So, what we would like to see next year when we report our data in the first half of the year in this initial data at least is we'd like to see a very solid overall response rate. We'd like to see some durability there. We'd like to see some really nice durability in terms of how long some of those last and then an increase over time in response rate itself and then also a complete deepening of the responses as well. So, I think those are some of the key measures. But really, I would like to really emphasize that it's really totality of evidence rather than a single measure or 2.

We will take our next question, the next question comes from the line of Nick Quartapella from Baird.

This is Nick on for Colleen. Can you help quantify the increase in duration on LOQTORZI that you're seeing? And can you speak of what you think might be driving that increase and whether you think there's room for that to grow further? And I have a follow-up question after that.

I'm sorry, Nick, what particular indication did you have in mind?

Sorry, this is on commercial for NPC.

Great. Do you want to talk about that, Sameer?

Thank you for your question, Nick. The duration of therapy continues to increase each quarter. Although we haven't yet reached the average duration of therapy observed during the clinical trials, this is primarily due to not having enough time in the market. It's still early in the launch to provide an exact figure for the duration of therapy. However, we are seeing a positive trend in the average duration for both monotherapy and combination therapy indications each quarter. Once we have reliable numbers regarding the average on-market duration, we will share that information in a future call.

Did you have a follow-up, Nick?

I did, yes. For the CHS-114 tori study in second-line head and neck, can you discuss the expectations around the dose optimization data expected in the first half of '26, what you're hoping to demonstrate, and what the subsequent steps for that program will be?

Great. Head and neck, Rosh?

Yes, we are conducting a study in second-line head and neck treatment involving 40 subjects, where we are testing two biologically active doses of casdozo combined with toripalimab. The trials are proceeding well and on schedule, and we expect to have efficacy and safety data available in the first half of the year. It's crucial to consider the totality of evidence. Currently, the standard of care in this setting involves cetuximab, which shows about a 13% overall response rate. We aim to significantly surpass that. Additionally, we are focused on achieving durability and disease stability. The results we shared at AACR have been encouraging as we continue with this ongoing trial.

An important output of that study, too, is the biopsy data as well as the dose to get to a recommended Phase II dose. And we did have a very productive Type B meeting with FDA, getting alignment on the data package we'll bring to them next year to declare a recommended Phase II dose, which will enable us to move more nimbly to have a single dose to look at in multiple indications.

We will take our next question, the next question comes from the line of Douglas Tsao from H.C. Wainwright.

Denny, I guess sort of sticking to the colorectal study, I guess just trying to sort of understand sort of the rationale. I mean, I think, Dosh, you mentioned that you're looking in the fourth-line setting sort of single-digit survival levels. And so just from your perspective, your expectation in terms of finding a really compelling signal in a population that is already quite sick.

Thanks for your question, Doug. I want to clarify that looking into the fourth-line setting is part of a broader development plan that enhances our position in the treatment landscape over time. I believe we have a solid and effective strategy, and we can discuss this in more detail later. Regarding your specific question, I will let Dr. Lavallee explain two things. First, the mechanism of action and rationale, especially for colorectal cancer concerning CHS-114 or Treg depleters. Secondly, how positive results from that study will prepare us for future studies. Theresa?

Yes. So, the importance of the clinical program with 114 goes to what I started with, that it's really designed to inform us. So, the colorectal is an important tumor type for several reasons that it has a good density and prevalence of CCR8-positive Tregs. Alexander Rudensky, one of the real pioneers in Tregs and CCR8 biology has published several papers on the diversity and differentiation of Tregs, particularly in the colon, showing that the CCR8 positive Tregs are really the pathogenic ones. So, gives it a stronger sense in that tissue that, that tumor should be particularly sensitive. Colorectal has not MSS colorectal. So, we know from the microsatellite instable population that a PD-1 inhibitor can work in the disease in the right context. But 85% to 90% of colon cancer is MSS microsatellite stable CRC, which PD-1 inhibitors have failed. And a large component of that is the high density and prevalence of Tregs. So, colorectal is particularly exciting given the biology. Shionogi with a CCR8 antibody that is not ADCC enhanced showed a complete response and partial response with single-agent treatment at ASCO this year. We've seen some long-term stable disease in our early clinical program. So, that signed together with toripalimab really sets as an exciting opportunity to bring immunotherapy to a tumor type that hasn't had any. So, the totality of data, the preclinical, the clinical and the biology of the target give it a very important attribute. As Denny said, the other things we're testing are the highest density of CCR8 positive in gastric cancer and head and neck cancer. And then esophageal, which is a little different in that toripalimab has differentiated activity and an approval in Europe. So, I think strategically, the whole program gives us a lot of levers to look at how we can do the fastest development with the highest impact to advance the program.

Thank you, Theresa. Doug, I would just anecdotally add that we are very honored to have Dr. Alexander Rudensky as a key member of our Scientific Advisory Board because he is really one of the seminal leaders in this entire field of Tregs, which has now come to the fore. And I think he's responsible really for a large part of our scientific leadership in this field, which, as I said in my prepared remarks, we look forward to continuing into 2026.

This concludes today's question-and-answer session. I'll now hand the call back to Dennis Lanfear for closing remarks.

Thank you, Heidi, and thank you all for joining us on the Coherus Oncology Q3 call this afternoon. I would just add that we will be at the UBS Conference in Palm Beach, Florida, and we will also be attending Jefferies in London, and we hope to see you there. Thank you. Bye-bye.

Goodbye.

This concludes today's conference call. Thank you for participating. You may now disconnect.