CHRS

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 first quarter 2026 earnings conference call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus; Dr. Rosh Dias, Chief Medical Officer; Dr. Theresa LaVallee, Chief Scientific and Development Officer; Sameer Goregaoker, Chief Commercial Officer; and Bryan McMichael, Chief Financial 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. Now I'll turn the call over to Denny.

Well, thank you, Carrie, and thank you all for joining us this afternoon on our Q1 2026 quarterly call. Let me first give you a quick flyby of the company's strategy to make sure we level set everyone, including our new investors. That strategy starts with LOQTORZI, our next-generation differentiated PD-1 inhibitor, which is both a revenue generator in the context of nasopharyngeal cancer and a revenue multiplier in the context of its combination with the novel molecules in our pipeline, such as casdozokitug, which we are exploring in liver cancer, and tagmokitug, which we are exploring across a number of cancer indications, including gastrointestinal, head and neck, and most recently, prostate cancer. We are executing a well-integrated financial, commercial, and development strategy that maximizes LOQTORZI's potential across both these dimensions while moving the pipeline forward efficiently.

NPC is large enough to cover the core cash burn at a projected $175 million a year peak share, which does not include clinical trial costs, something which we view separately. Proprietary combinations of LOQTORZI with the pipeline asset translates to a 2-for-1 win. Label expansion for LOQTORZI included upon any approval. This will, of course, also translate to commercial synergies. This is how we can target $33 billion in market opportunity with our current efforts. The third leg of the strategic triad is a Treg depletion with tagmokitug across cancers and across non-proprietary combinations, which we view as a foundational Treg depletion platform and not merely another checkpoint adjunct. We further wish to explore Treg depletion as a potential new scaffold across cancer therapies. Tregs broadly mediate immune response, and cancer hijacks immune mediation to grow and proliferate.

Many cancer therapies either result in or are limited by Treg gone awry. Our strategic objective is to broadly deploy tagmokitug across cancers and non-proprietary therapies. Last quarter, we concluded the first such arrangement with J&J in prostate with pasritamig, a T-cell engager. We are currently exploring other partnering opportunities, which include not just T-cell engagers, but ADCs, radiotherapy, and various bispecifics. As we have been saying for some time across all of our presentations, CCR8-based Treg depletion could be challenging for a lot of reasons. You need to have the right molecule and the right target. The right molecule translates to a number of things across selectivity, affinity, pharmacology, and all the rest. The right target translates to immune context and the nuances of the biology.

More recently, it's become clear that the therapeutic promise of Treg depletion notwithstanding, some market participants are pausing or stopping the programs while others are accelerating and expanding the programs. It's essential for all of us to understand the nuances playing out. Accordingly, I've asked my Chief Scientific Officer, Theresa LaVallee, to spend a few minutes with you today and provide a lens through which to view the field's evolution. I hope you find it useful. Also today, Rosh Dias, our Chief Medical Officer, will update you on the trials, enrollment, and the timing results. Sameer Goregaoker will review the Q1 revenues, as well as provide an update on our commercial execution.

We continue to project that we will hit some $15 million per quarter sometime this year in 2026 and $30 million-$35 million per quarter sometime in 2027, and a market share peak of about $44 million per quarter sometime in 2028, which translates to about $175 million a year. After Sameer, Brian McMichael will review for you our financials. With that, now let me turn the call over to Rosh. Dr. Dias?

Thank you, Denny, and good afternoon, everyone. We continued to advance our highly focused clinical development program for our pipeline molecules pazovocitab and tagmokitug through Q1, and we're pleased with our progress with both molecules, with accrual progressing well, and we are tracking to plan. Recently, we announced that we had completed our target accrual to our CATALYST-202 randomized study in first-line hepatocellular carcinoma.

As a reminder, this is a 72-patient rearm study investigating two active doses of casdozokitug in combination with toripalimab and bevacizumab versus toribevalimab, and is designed to further characterize the efficacy and safety of this triplet, as well as address FDA's Project Optimus and contribution of component. This study builds upon the previous data we presented last year at ASCO GI, where the combination of casdozokitug on top of the current standard of care of atezo and bev demonstrated an overall response rate of 38% and a very encouraging complete response rate of 17%, both of which are greater than the historical data for atezo/bev alone of 30% and 7.7% respectively. Patient accrual has gone well, and we anticipate having initial data available around the mid-year timeframe as projected.

Given what we observed in the prior CADILYZE-202 HCC trial, we expect the response data to mature over time after that, perhaps quarter to quarter. Moving to tagmokitug, our CCR8 cytolytic antibody, we're currently running two active protocols in a targeted clinical program in tumor types where CCR8 intratumoral expression levels and the demonstration of activity previously in the CCR8 field provide rationale for investigation. Our first protocol expands our approach in head and neck squamous cell carcinoma and builds upon the late line head and neck squamous cell data we presented at AACR 2025, where we demonstrated tumor immune cell remodeling to a more cytotoxic state with tagmo monotherapy and a partial response in the fourth line patient with the tagmo/tori combination. Our current 40-patient expansion explores two active doses of tagmo in combination with tori, specifically in a second-line population.

Accrual has progressed well, and we anticipate having data for 40 patients with a varying number of scans around the mid-year frame. Our second protocol looks at multiple cohorts under an umbrella protocol as previously discussed. Cohort A investigates the tagmo/tori combination in 40 patients with second-line upper GI adenocarcinoma, which includes gastric adeno, gastroesophageal junction adeno, and esophageal adenocarcinoma in two dose levels of tagmo in combination with tori. This cohort is ongoing and continues to accrue well. We anticipate having initial data available mid-year as projected. Cohorts B, C, and D are all active and accruing, and we remain on track to show initial data through the second half of this year, as previously communicated.

Cohorts B and C of this protocol are in esophageal squamous cell carcinoma, where the activity of toripalimab irrespective of PD-L1 status is particularly marked and forms the basis of toripalimab's approval in Europe as the only PD-1 approved across all PD-L1 levels in this tumor type. We're investigating the tagmokitug/toripalimab combination in second-line ESCC, and in first-line ESCC, we're exploring tagmokitug and toripalimab in combination with chemotherapy as a safety cohort. Cohort D is exploring tagmokitug and toripalimab in fourth line plus microsatellite stable colorectal carcinoma without liver mets, an area of increasing incidence, particularly in younger age groups, and where there is a large unmet medical need as the current standard of care demonstrates very limited benefit.

Lastly, we've made excellent progress on the J&J pasritamig T-cell engager combination cohort of tagmo in prostate cancer, which will be the first of a new multi-cohort protocol, which is an approach that will enable us to add additional tagmo combination cohorts with other novel mechanisms under a single protocol efficiently. We continue to anticipate first patient in this fall. With that, I will hand it over to Theresa. Theresa?

Thank you, Rosh Dias, good afternoon. Today, I will cover three topics. Two aspects for tagmokitug. As the CCR8 competitive field is evolving, I will briefly review the importance of pharmacology in drug development, and then I will review our own tagmokitug pharmacology data to date. These data have supported the opportunity to expand tagmokitug development with J&J T-cell engager pasritamig, a novel combination with CCR8-depleting antibodies and a potentially complementary anticancer therapy. We are excited this is our first non-proprietary combination to advance to clinical development. Let me start with reviewing some of our analysis plans for the casdozokitug randomized CATALYST-202 study. Having the casdozokitug HCC study fully enrolled now allows for the biomarker analysis to be done. We have prioritized two aspects for data readouts, biomarkers associated with response and pharmacodynamic biomarkers to support contribution of effect for casdozokitug.

The previous casdozokitug HCC study provided a small data set suggesting that higher levels of IL-27 expression in tumors were associated with response. We had just seven tumor samples, which is only 25% of the evaluable patients. Despite that, the analysis showed the tumors from the four patients with response had a higher level of IL-27 protein compared to the three progressive disease patients. In the current CATALYST-202 study, we obtained pretreatment tumor samples for almost all of the patients and expect to have IL-27 expression data when we read out the study. We also plan to perform circulating tumor DNA analysis. Circulating tumor DNA is emerging as an important biomarker to evaluate tumor burden and treatment response. As tumor cells grow, they shed DNA into the patient's blood, and many studies show a decrease in circulating tumor DNA levels following treatment correlates with better survival outcomes.

Circulating tumor DNA already serves as a marker for minimal residual disease in hematological malignancies, and there is a large effort in the field to have the same for solid tumors. Given the delayed responses in HCC, we are interested in exploring this as an earlier surrogate marker for efficacy. Let me shift now to our cytolytic CCR8 antibody, tagmokitug, which we are investigating across a number of indications. As the competitive field is evolving, with some teams pausing or stopping their programs, while others are advancing their programs into late-stage development, these disparate outcomes may be explained by the basics of drug development. Early-phase clinical studies must answer two questions. Right drug, right target. To have the right drug requires four critical pharmacological elements.

Good PK and potency, showing you can deliver the drug at the needed exposure, thirdly, dose-dependent effects on the intended target, showing the drug has hit the target and affected the target as related to dose. Fourthly, an acceptable safety profile alone in combination. The majority of the CCR8 antibodies aim for a bind and kill MOA to deplete intratumoral Tregs. However, as we have consistently stated, the CCR8 receptor is a GPCR. It is well-known GPCRs are challenging to make selective and potent antibodies against. This is now being reinforced with the CCR8 class. In April, at the AACR meeting, Amgen and Gilead presented on their CCR8 programs. The data show mixed results, these antibodies show a toxicity profile that is not seen by some other CCR8 programs. Amgen halted enrollment in their program after presenting data showing only two responses in 77 patients treated.

About a third of the patients were treated with a combination of AMG 355 and pembrolizumab. From the 12 with gastric cancer, 1 partial response was observed. These results contrast with the gastric cancer data from LaNova Medicines, now Sino Biopharmaceutical, where LM-108 in combination with PD-1 inhibitors demonstrated a 36% overall response rate. Gilead, in contrast, showed antitumor activity, including single-agent activity in tumor types known to have a high degree of CCR8-positive Tregs. Gilead is now advancing their Denoskitug into phase II development in multiple studies, and we await additional datasets. In summary, it would seem that many CCR8 programs that are stopping are doing so due to drug-like properties falling short and failing the right drug criteria. In contrast, tagmokitug has shown good pharmacology and has met all the criteria for right drug.

Excellent linear dose and dose-dependent PK, potency for both binding and killing the target, dose-dependent immune effects, and acceptable safety profile both with and without toripalimab. With the right drug under investigation, we have now turned our attention to answering the question of hitting the right target. As you have seen, we are aggressively pursuing data to support right combination for the best efficacy across cancers, lines of therapy, and immune context. We are evaluating tagmokitug in combination with either toripalimab, a PD-1 inhibitor, or pasritamig, a T-cell engager. We plan to evaluate tagmokitug in other combination where Tregs are associated with therapy resistance, such as ADCs or radiotherapy. We believe this will inform our inde-development broadly across anticancer therapies on the best way to overcome Treg-driven resistance in cancer patients. With that, I will turn the call over to our Chief Commercial Officer, Sameer Goregaoker.

Thank you, Theresa, and good afternoon, everyone. Today, let me offer you some color on our Q1 results, what we saw with respect to demand signal, and our focus going forward to drive growth. In Q1 2026, LOQTORZI net sales were up 61% versus Q1 2025. On a quarter-over-quarter basis, net sales were $11.8 million versus $12.4 million in Q4 2025. This result was consistent with typical 1st quarter seasonal trends, but this year it was impacted by severe weather across large parts of the country, as others have also seen. To better understand this year's seasonal impact, we assessed a basket of 85 oncology products. We found an average of 5% decline from Q4 to Q1 over the past four years.

However, in 2026, the decline for this basket was more pronounced at 10%, likely driven by the severe winter storms that hit most of the country. With this seasonal impact now behind us, we expect LOQTORZI revenue growth to build through the remainder of 2026, given a closer analysis of our growth drivers. We are pleased to report that LOQTORZI new starts reached an all-time high in Q1. This was driven by, one, broader prescribing in new accounts, and two, deeper use through repeat ordering in existing accounts. Overall, breadth and depth of ordering accounts increased 21%, and treatment duration continues to increase quarter-over-quarter. Looking ahead, we see two clear levers to drive continued demand growth.

We're focusing on reducing chemo-only use, particularly in the community setting, through continued education on NCCN guidelines and our phase III data, including the six year long-term survival benefit analysis. We're working to curb off-label PD-1 use in NPC that is mainly driven by guideline and indication misperceptions. On both fronts, our efforts reinforce LOQTORZI's position as the only approved and available immune therapy in NPC, offering a superior survival benefit over chemotherapy alone. We're moving this plan forward utilizing targeted investments to enhance our execution. Importantly, new claims data purchases have expanded our visibility into chemo-only and off-label IO use across up to 70% of addressable patients. This expanded visibility is being incorporated into patient alerts to enable earlier, more precise field targeting and multi-channel execution. Our inside sales team is now fully operational, significantly expanding our reach into the community setting, a key growth driver.

We're also scaling digital education through KOL video programs, targeted EMR initiatives, and pilots on emerging HCP AI platforms. These AI platforms are seeing rapid growth by rapid adoption by oncologists and are increasingly used to drive treatment decisions. Regarding our guidance, we continue to expect 10%-15% demand growth per quarter averaged across 2026 quarters. Our focus will continue to be on driving broader and deeper adoption across the community and academic settings, supported by growing durational treatment. With that, I'll now turn the call over to Bryan McMichael, our Chief Financial Officer.

Thank you, Sameer, and good afternoon, everyone. I'll start with notable financial and operational updates, then run through the company's financial position at the end of the quarter and results for Q1 2026. The key financial event this quarter was the follow-on equity offering, which we mentioned on last earnings call. As an update, total net proceeds were $54 million and include the full exercise of the underwriter's over-allotment option. These funds have strengthened our liquidity position and are supporting the new cabrolitug CRC and prostate studies, enhanced investments in LOQTORZI commercialization capabilities to reach revenue targets faster, and general corporate purposes. Regarding sales, in addition to the color on LOQTORZI net revenues provided by Sameer, I will add that we expect to provide full year 2026 revenue guidance on the earnings call in August, as indicated on our last call. Let me turn to operating expenses.

R&D expenses from continuing operations for Q1 2026 were $21.5 million, down from $24.4 million in the first quarter of the prior year. The decrease was primarily due to savings from reduced headcount and infrastructure costs, reflecting tight spending discipline, partially offset by increased investments in the pipeline. SG&A expenses from continuing operations were $23.1 million in the first quarter, down from $26 million in Q1 2025. The decrease reflects continued savings from Coherus' complete exit from the biosimilar business, which as we talked to you today, was completed more than 1 year ago. Turning to the balance sheet. Total cash equivalents, and investments at the end of the quarter was $167 million, down slightly from $172.1 million at year-end.

Given the recent raise in our financial plans, we believe we are sufficiently funded through key data readouts in 2026 and 2027. With that, I'll hand the call back over to Denny.

Thank you, Bryan. Operator, we're ready to go to the questions.

Thank you, If you wish to ask a question you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again.

We will take our first question. The first question comes from the line of Jay Olson from Oppenheimer. Please go ahead. Your line is open.

Oh, hey, thank you for providing this update and for taking our questions. On LOQTORZI, can you talk about the dynamics driving the average duration of treatment among existing patients, which continues to grow? Is the growing duration driven by 1st-line patients? Related to that-Congrats on the new patient starts in the 1st quarter. Can you maybe share some color on how the patients split between 1st and 2nd line? Where should we eventually expect the percentage of patients on LOQTORZI in the 1st-line setting? If I could, I have a follow-up on TAGMO, please.

Good. Thank you, Jay. I'll let Sameer unpack that for you. Sameer, would you like to address Jay's question?

Yeah

About the treatment duration and so on?

Thank you, Jay. Thanks for the question. You know, you had a couple points to that question, so just make sure I got your question correctly. The first question was the average duration of treatment and how that split between new and existing patients. Is that correct, Jay?

Yes.

Yeah.

Yeah. Yeah.

In terms of the duration of treatment, what I can say is our duration of treatment depends on the type of patients. We have two types of patients. One type of patient is the first-line locally advanced and first-line metastatic patients. The 2nd type of patient is a monotherapy patient, which is the later-line metastatic patients. In the clinical trials in the real world, we're seeing higher duration of therapy for the first-line patients than the second-line monotherapy patients. In terms of new and existing patients, I think it's the same dynamic playing out for both the new and existing patients. Across the board, we're seeing that the duration continues to grow, as we get further away from launch, and eventually, hopefully, we'll get close to the clinical trial duration.

Okay.

The next question was about new patient starts in first line and second line. Currently we're seeing about 75%-80% of our patients are coming from the metastatic setting, both the front-line metastatic setting and the second-line metastatic setting, and a smaller % of patients coming from the locally advanced recurrent setting. That's in line with physicians initially at launch, putting patients on a later line patients and then moving the use of therapy to an earlier line setting. As we get further into the launch, we would expect that we get more locally advanced recurrent patients. Last thing I'll say is we also now have visibility into where these patients are.

We've purchased a lot of claims data, so we know which physicians are managing these locally advanced recurrent patients, and we're going after those accounts and physicians to educate them on LOQTORZI.

Thank you, Jay, and thank you, Sameer.

Thank you. That's super helpful.

We're ready for the next question.

Oh, could I ask?

I'm sorry. Go ahead. Sure.

Thanks. That was super helpful and extremely comprehensive, so thanks for the detailed explanation. Just on TAGMO, given that the second line head and neck and gastric cancer readout is expected midyear, could you just talk about what investors should expect to learn from those two updates? Will you be providing, next steps in the clinical development for those two programs?

Rosh Dias, you wanna take that one about the data, and then, Theresa LaVallee, you can take next steps.

Yeah. Thank you, Jay, for the question. In terms of data readouts, yeah, we anticipate initial data for the 2nd line head and neck and the 2nd line upper GI adeno around the mid-year timeframe. Couple of things I'll say. First of all, you know, we anticipate at least 50% of the patients to be reported. You know, as you think about the data and timing, there are probably two key determinants, right? One is the number of patients. Number two is the number of scans that may be needed to show activity. Again, for the number of patients, I anticipate more than 50% or more of patients. In terms of the numbers of scans, that's a little bit more variable. We'll be looking at overall response rate.

We'll be looking at clinical benefit rate. We'll be looking at safety, but duration will take a little bit longer to really mature. As you know, the real benefit of IO has been in extending that tail. I'd look out for those key metrics to start with.

Great. Thank you very much.

Yeah. I think just to add to that, Jay, thanks, because we're super excited to think about next steps. As we look at the data, particularly with durability, I mean, ORR is nice. It's, you know, 30% or greater tumor shrinkage. Durability is what matters, though, 'cause the regulatory endpoints are survival. Thinking about, is there sufficient efficacy to support favorable regulatory strategies, which all of these studies are designed, if the signal's there, to have sufficient patients to do that. Additionally, is there a patient population or a way of enriching patients, is another output that we're really looking at for what's the immune context, and is there a way then to advance into a study to look more towards later stage development.

We'll be looking for both of those outputs and directions from the studies as they read out.

Great. Thank you so much.

Thank you, Jay.

Looking forward to it.

We're ready for the next question, operator.

Thank you. Your next question comes from the line of Paul Choi from Guggenheim. Please go ahead. Your line is open.

Great. Thanks so much for taking the question. For TAGMO, I have a follow-up question on the head and neck cancer data that you'll be reporting, mostly around patient demographics. Can you speak to what proportion of patients you would expect to be PD-1 experienced? Do you plan to break out responses by HPV status? Then how do you think about the bar for response?

Okay, hold on, Paul. Let's Paul, yeah, Paul, well, Paul, let's stop there and just do one question. Let's answer that, then we can follow on. Theresa, Rosh Dias, can you take that?

Yeah, I can take that. Thanks, Paul, for the question. Yes, all of the patients in the second line head and neck study will be PD-1 or PD-L1 experienced. Yes, one of the key stratification factors is the HPV status.

Did you have a follow-up question, Paul?

I did, yeah. I just wanted to ask about how you're thinking about the bar for response rates in light of what some of the investigational EGFRs and even ADCs have shown in the setting.

Yeah. I can take that one as well. First of all, you know, the current standard of care is pretty dismal in terms of the overall response rate. It is cetuximab, and that overall response rates tends to be in the 13%-15% ORR range. You're absolutely right. We do see the environment changing and evolving with the EGFRs. A couple of points I'll mention. First of all, there is positive data in the first line as well as the second line setting, which I think better positions these agents in the first line setting. Secondly, you know, I think the majority of the benefit is really driven by HPV negative status.

You know, I think that also leaves the HPV-positive patients, which accounts for roughly about 40% of subjects overall, pretty wide open. I think that's the way we kind of look at the current benchmarks and the evolving datasets.

Theresa, additional comment?

We're actively watching it, obviously, with announcements from the Nectin-4 ADC data that's super exciting, shows a rapid development path in the head and neck space. Hibrix data coming out really showing a non-EGFR approach in the frontline setting shows room and interest for novel agents. What we find particularly interesting about this mechanism, obviously our initial output is with PD-1 and Tagmo. To your question, the first study is only asking, "Can we rescue PD-1 resistance?" since they're all PD-1 failures. Moving into combination with any and all of these agents could make a lot of sense. In addition to streamlining our development with a way to advance to later stage, we also see ways to broaden and improve on durability of a lot of these responses, particularly with ADCs, as we do combinations.

Thank you. Thank you very much, Paul. Heidi, we're ready for the next question.

Thank you.

Thank you. We will take the next question. Please stand by. Your next question comes from the line of Brian Cheng from JPMorgan. Please go ahead. Your line is open.

Hi, guys. Thanks for taking our questions this afternoon. Maybe just first on LOQTORZI. Can you provide a little bit more about this weather impact to the top line here? Are patients not able to get another round of LOQTORZI? Is there access issue because of weather? Just, you know, just on top of this, how do we reconcile that dynamic with the record new patient starts that you're seeing this quarter? We have a follow-up. Thank you.

Okay. Thanks, Brian. Sameer, you wanna take that?

Thank you, Brian, for the question. We're now into the third year of our launch, so we're getting a better sense of the seasonality patterns. We saw some seasonality last year. It was kinda early to understand that. This year again, we saw the seasonality, and that's why we dug into an analysis of what's really happening in the oncology setting. We took a basket of 85 oncology molecules. Really interestingly, for the last four years, this basket, we saw a very consistent 5% decline from Q-four to Q-one. What we didn't expect is a larger magnitude of decline in 2026, where we saw a 10% decline for that basket from Q-four to Q-one.

It's like, as we expected, it's a pretty consistent decline pattern in Q-one, most products go back to growth in Q-two. We're following a similar pattern it looks like, right? That being said, in terms of reconciling the new patients and the existing patients, we believe what happened is we had, I think about two major winter storms which affected about two to three weeks throughout the first quarter. I think what happened is a lot of patients who are on either three-week cycles or two-week cycles missed their cycles. As a result, we lost that entire cycle for big chunks of patients, and they reset their cycle clock. We lost these individual cycles for chunks of patients. That is totally separate from the new patient starts, right?

New patients are really important for us to drive future growth, and we're pretty excited that we saw robust new patient growth, which is gonna become the existing patients for future quarters. Those are the two dynamics that played itself.

The other, the other point I say, Brian McMichael, is I think Q4 to Q1 last year, we went down I think about 3%. This year I think it's like 5%. Given the storms, you know, it's pretty much in line. Also given these starts, I think that we should go back on the growth curve here directly this Quarter now. Did you have a follow-up question, Brian McMichael?

Yeah, we do. Maybe just on the CADILYZE 202 study. Theresa LaVallee, you talked about how, you know, the importance of circulating tumor DNA and also IL-27 expression in the upcoming data read, you know, in terms of, you know, figuring out the association of those expressions to tumor reduction. Do you have a sense, based on preclinical model, do you have a sense of how correlated they are, you know, in terms of the magnitude of IL-27 reduction to tumor reduction in preclinical model? Thank you.

Thanks, Brian.

Yeah. It, the preclinical models don't have a good readout there. I mean, what we have seen in the mouse is that it's very tissue specific, so that the tumors have to be in the lung or the liver. Given the amount of IL-27 that's expressed there, that comes through. The two things that we're really looking for, I think, just to set expectations for the mid-year readout, we've talked about this at several times, is that it's an initial readout. The first readout in the CAS CATALYST-201, the previous atezo/bev study, the overall response rate was only 27%. A lot of patients were on study, and we saw tumor shrinkage deepening.

That's where we think that the initial readout with trends in circulating tumor DNA, as well as looking at are there differences in the outcomes based on IL-27 levels, will really give us a look-see about the probability of it being a positive study as the data mature.

Thank you. Thank you, Brian.

Great. Thank you.

All right. Heidi, we're ready for the next question.

Thank you. As a reminder, if you wish to ask a question, please press star one one on your telephone. As a request, if you wish to ask more than one question, please ask one question at a time. We will take our next question. Your next question comes from the line of Colleen Kusy from Baird. Please go ahead. Your line is open.

Hey, everyone, it's Nick on for Colleen. Thanks for taking the question. Just had a quick one on the Casdozo program. Between AtezoBev and ToriBev as the backbone in combination there, do you expect to see any differences in the efficacy or safety profile? Thank you.

Yeah. Thanks, Nick, for the question. I think you'll recall that we talked about HEPATORCH, which is the study of toripalimab and bevacizumab versus sorafenib. That really showed very similar, if not slightly higher, overall survival compared to AtezoBev, obviously not a head-to-head. I think we have confidence in that. The other thing I'll say is that the ADA rates for tezo tends to be a lot higher than the toripalimab. I think those two points really give us some confidence that the ToriBev is a good backbone on which to add casdozokitug.

The safety profile has been quite good. That's actually one of the standouts, particularly in this disease in the frontline HCC study. casdozo, across the board, really hasn't added any additional or new toxicities to any treatment, whether it be atezolizumab, whether it be toripalimab, whether it be pembrolizumab, that has been evaluated to date.

Great. Thank you.

Thank you.

Thank you. We will take our next question. Your next question comes from the line of Michael Nedelcovych from TD Cowen. Please go ahead. Your line is open.

Hi. Thanks for the questions. I have two. I'll start with my first on tagmokitug. Theresa, you alluded to this in your remarks, but I believe LaNova Medicines has initiated a phase III trial for its CCR8 antibody. Can you elaborate a bit on your previous remarks? How important is this development from the point of view both of validating the mechanism but also in terms of what it means for the competitive landscape? To the extent that you can speak to specific similarities or differences between their molecule and approach to tagmokitug, that would be super helpful. Thanks.

Thanks for that, Mike. Theresa?

I love this question, and I think this is really important because we see programs advancing and programs stopping. Sino Biopharmaceutical with LM-108 cafelkibart and have started two phase IIIs. In fact, last week they announced dosing the first patient in the gastric cancer phase III. They also have a MSI-H CRC study as a pivotal study ongoing. They really have confidence and are doubling down on this program and the molecule, and they also will be reporting at ESMO this year. Additionally, we see players like Gilead opening two phase II randomized study, gastric cancer, colorectal cancer. AbbVie advancing in colorectal cancer, and Bristol Myers Squibb continuing to add patients to their study.

We think that the differences, you know, from the programs that are being parked or the negative data that, the lack of activity that Amgen showed comes down to pharmacology. We're super excited about seeing programs advancing and seeing the properties of our molecule really making it exciting to now look at the data readouts later this year.

Mike, did you have a follow-on question for us?

I have another on LOQTORZI, if that's okay.

Sure.

I'm just curious, given that you now have a better sense of seasonality, do you still think LOQTORZI can get to that roughly $30 million-$35 million in quarterly sales in 2027, or might it take a bit longer than that?

We are confident in doing so. In my prepared remarks, I reiterated guidance on three key issues with respect to the revenues. First, being reaching $15 million per quarter sometime this year in 2026. Second, reaching $30 million-$35 million per quarter sometime in 2027. Thirdly, reaching what would be an annualized $175 million per year, which is about $44 million a quarter, sometime in 2028. I think that our data purchases and our knowledge now of the therapeutic area gives us confidence we'll be able to do that.

Great. Sorry I missed that. I appreciate the update. Thanks all.

Thank you, Mike.

Thank you. Once again, if you wish to ask a question, please press star one one on your telephone. We will take our next question. The question comes from Douglas Tsao from H.C. Wainwright. Please go ahead. Your line is open.

Oh, sorry. Can you hear me?

Yes.

Hello? Can you hear me?

Hi, Doug. Yes, Doug. Hello.

Sorry about that. I had you on unmute at first. Just thanks for taking the questions. I guess just maybe on the LOQTORZI issue in terms of the impact on storms, was this something that affected largely new patient starts, or was it just simply a function of patients' ongoing therapy? Should we think of this as just sort of purely deferred revenue that eventually should catch up for the rest of the year?

Sameer, you wanna take that one first, Doug?

I'll take a shot at that. Thank you, Doug, for the question. I think, the first part of that question is, I believe it affected our existing patients. New patients that I mentioned in my prepared remarks, we had, you know, more new accounts either starting or restarting new patients than we had in the past. Our new patient growth seems robust. I believe what happened is the existing patients, because of seasonality insurance changes plus the weather, there were some hiccups in ongoing treatment. That's where we lost some cycles. I don't think we're gonna get those cycles back because if you're on a three week cycle and you miss your cycle this week, you basically go back on a new three week cycle, so that one cycle is lost basically forever.

Again, let me just kinda go back to what we said earlier, right? That's Q1, right? We're pretty excited about the new patient starts continuing on track and our ability to drive demand growth for the rest of this year.

Thanks, Sameer.

Yep.

Thank you, Doug.

Yeah, thanks. Can I jump in with a follow-up, Denny?

Sure.

Just maybe on TASMO, you know, obviously we have a significant number of readouts through beginning in the middle part of the year and into the second half of the year. I guess just when you think about where you are from a balance sheet, Denny, you know, are you able to And, you know, I think you would certainly play to succeed or assume that you're gonna succeed with these studies. You know, do you think that you're in a position to continue to sort of prosecute all these opportunities? You know, is there some prioritization that might need to happen?

Yeah. I would direct you back to my prepared remarks at the beginning of the call. We are, you know, certainly funded through 2026 then all the 2027, turning over of all the data cards. One thing that we do is if we have a unfunded clinical trial or we have something that we believe is worthwhile, you know, we take it to our investors. As currently all of our clinical trials are funded. We just raised, as you know, that really addressed the issues with the CRC study, which were not funded, as well as the prostate study with Johnson & Johnson. Both of which, I think you'd agree are very worthwhile. That's pretty much our approach to it.

We don't foresee any additional trials right now. I think that we've done a very good job with a very broad development program across tagmokitug and a very highly focused program with respect to toripalimab. I think we're set.

Okay, great. Thank you.

Thank you, Doug.

Thank you. There seems to be no further questions. I would like to hand back for closing remarks.

Thank you, Heidi. Thank you all for joining us today on our Q1 2026 call. We look forward to seeing you again on our August call, which will be very exciting. In the interim, we'll see you at Jefferies, where we'll be presenting, and we'll also be at ASCO. Thank you. Bye-bye.

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

Good day, and thank you for standing by. Welcome to the Q4 and Full Year 2025 Coherus Oncology, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. 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, welcome to Coherus Oncology's Fourth Quarter and 2025 Year-End Earnings Conference Call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus, Dr. Theresa LaVallee, Chief Scientific and Development Officer, Dr. Rosh Dias, Chief Medical Officer, Sameer Goregaoker, Chief Commercial Officer, and Bryan McMichael, Chief Financial 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. We undertake no duty to update or revise any forward-looking statement. Please see the press release that we issued today and our annual report on Form 10-K for more information on risks and uncertainties. Now I'll turn the call over to Denny.

Thank you, Carrie, and thank you all for joining us today on our Q4 2025 call and our 2025 annual summary to investors. This was a year in which we completed our strategic transformation to an innovative oncology company focused on overcoming immune resistance in cancer. This transition was initiated in September of 2023 with the acquisition of Surface Oncology, a transaction through which we acquired two very promising assets, tagmokitug, a potentially best-in-class CCR8 Treg cell depleter, and Casdozokitug, a first-in-class anti-IL-27 inhibitor. Over the subsequent 18 months or so, we have successfully divested our biosimilar franchise, putting $250 million in the balance sheet, reduced our $480 million secured and convertible debt by over 90% to $38.8 million, reduced our headcount and expenses, sharply refocusing the company.

Building on our past successes, we enhanced our team as well as our board of directors to meet the new mission. We also initiated an elegantly efficient clinical development program across our pipeline products in combination with LOQTORZI as well as partners products, potentially enabling the initiation of a registration trial in 2027. You'll hear details of our clinical strategy and progress from Dr. Rosh Dias, our Chief Medical Officer. We also launched our first innovative oncology commercial product, LOQTORZI, in 2024, a next-gen PD one inhibitor as the only available and approved product for recurrent, locally advanced or metastatic Nasopharyngeal Carcinoma in the U.S., a $250 million addressable market. We have made very rapid progress on our transformation in the context of our products, our development strategies, and our deal-making.

Let me provide you with a strategic lens through which to view the company going forward. First, to our financial strategy. LOQTORZI plays a foundational role as both a revenue generator in the context of NPC and revenue multiplier in the context of combination therapy with our pipeline assets. I believe Coherus is unique as a clinical stage small biotech company because we have a commercial asset with growing sales in a rare disease space with no FDA-approved competing products on the horizon, outstanding six-year survival data, and we are positioned at the top of the NCCN guidelines for recurrent metastatic NPC. This gives us confidence in LOQTORZI's continued growth. As you will hear from my colleagues, LOQTORZI more than doubled its sales in 2025 over 2024.

We view LOQTORZI as reliable, growing, non-dilutive revenue source and financing vehicle to support operations while we advance the promising pipeline, increasing in value along the way. That's its fundamental role. Our expected trajectory achieves peak market share sometime in 2028, corresponding to $175 million in annualized revenues or about 70% market share of the $250 million market total. You will hear more about that from Sameer Goregaoker, our Chief Commercial Officer, in just a moment. Let me make some key observations for you. First, while $175 million a year revenue may appear modest, it's very important to us as it's more than sufficient to fund our core burn and overall headcount, not including development costs or other extraneous items like stock option expense.

Secondly, along the way, once we achieve about $15 or $16 million a quarter in sales, the commercial effort will have paid for itself and start contributing to covering the company's overall SG&A. We believe this will happen sometime in 2026. Lastly, once we achieve approximately $30million-$35 million per quarter, our core burn, which does not include clinical trial expense, which are somewhat elastic and discretionary, will be paid for by such revenues. We believe this will happen sometime in 2027. We recently raised about $50 million, which included support for the commercial effort, so we can get to that $175 million run rate faster. Also, we deemed it strategically prudent to further invest in the tagmokitug clinical program as the Treg field is increasingly competitive with some expected data readouts by other parties this year.

Given the recent raise in our financial plans, we believe we are certainly sufficiently funded through key to day layouts in 2026 and on into 2027. My Chief Financial Officer, Bryan McMichael, will provide more color in just a moment. Let me turn to our product strategy. In addition to LOQTORZI, we have two well-positioned product candidates, both showing promising early clinical results. Their differentiated key attributes provide risk diversification for investors. On the one hand, we see tagmokitug as potentially a best-in-class in a competitive space with broad clinical therapeutic utility and very promising biology. In a moment, Dr. LaVallee will provide you some additional scientific insights on its mechanism of action and combination therapy considerations. The breadth of potential utility mandates broader early-stage clinical investigation, we have several trials underway.

We intend to exploit this potential broad utility by not just pursuing proprietary combinations, but also by joining with partners. Our objective to be the Treg depleter of choice across cancer treatments and modality. We also believe that Casdozokitug is the first and only in class and with impressive translational data sharply focused on various tissue cancers such as liver and lung. Consistent with that data, Casdozokitug demonstrated highly durable complete response rates in first-line Hepatocellular Carcinoma. Follow-on trial is underway. Dr. Dias will describe this to you subsequently. Lastly, let me talk about the deals. Coherus has a strong track record of creating value for investors with strategic transactions, including acquisitions, divestitures, and product partnerships. We believe that this demonstrated competency is the key to unlocking latent value, opening up new markets, and creating synergies therapeutically and globally.

As an example, I'll point out that the J&J collaboration is important for a number of reasons. First, it stands as the first example of our objective to be the Treg depleter of choice broadly across companies and treatment modalities. More such relationships are in development. Secondly, it stands as validation of our high scientific competency and the quality of our asset. Lastly, it shows that we have constructed a strategy that is both executable and potentially accretive to shareholders.

As you know, we have global rights to tagmokitug and Casdozokitug, and we look forward to ex U.S. partnership opportunities as the data readouts emerge this year and next. We believe that it is reasonable to expect such partners will provide upfront payments and contribute their share to significantly offset pivotal or registration trial costs as they carry the expenses for the patients in their territories.

This will leave us responsible for a minority share of overall costs, which we expect to be manageable. In closing, let me summarize for you. Over the last 18 months or so, we have made substantial progress on putting together a highly executable plan comprised of integrated financial, product, and transaction strategies, positioning us to provide significant investor value accretion. Let me now turn the call over to Dr. Theresa LaVallee, our Chief Scientific and Development Officer, who will provide some greater insights into the use of T-regulatory cell depletion as a therapeutic approach to overcome immune resistance in cancer. Theresa?

Thank you, Denny. Good afternoon. Today, I will focus my remarks on Tagmokitug, our potent and selective cytolytic anti-CCR8 antibody, its mechanism of action, and the potential for its therapeutic use. As background, T-regulatory cells, or Tregs, are an increasingly recognized important cell type for the treatment of cancer. As tumors exploit Tregs to evade the immune system, this has the consequence of promoting cancer growth and metastasis. Higher levels of Tregs are associated with poor prognosis in many different tumor types, including head and neck, lung, breast, colon, prostate, stomach cancers. The other problem with Tregs is that Tregs are not only associated with poor prognosis, but also can be upregulated with anti-cancer treatments. The reason I highlight this is as drugs that deplete Tregs may be able to improve patient outcomes for many different anti-cancer treatments.

Tagmokitug targets CCR8, which is preferentially expressed Tregs in tumors. We recently published the characterization of tagmokitug pharmacology in Molecular Cancer Therapeutics. What we have shown in the clinic with tagmokitug that treatment leads to two important changes in the tumor immune makeup. First, the selective and significant depletion of CCR8 positive Tregs in tumors. Second, a massive increase in CD8 T-cells. These data show that tagmokitug both removes the suppressor cell in tumors and leads to an increase in T-cells that can kill the cancer cells. However, the CCR8 class of drugs has shown limited single agent activity, which raises the question of what do these T-cells need to activate them to kill the tumor? We are investigating two different approaches for T-cell activation. PD-1 antibodies are one way to activate killer T-cells.

Over the last decade of using these drugs, we have learned the mechanism of PD-1 inhibitors is to reinvigorate T-cells that have previously tried to attack the tumor but are now exhausted. We are trying to understand if the T-cells observed in the tumors following tagmokitug treatment are antigen-experienced exhausted T-cells or possibly naive T-cells. Rosh will describe in more detail our tagmokitug clinical studies evaluating treatment with toripalimab, our PD-1 antibody. The results of our phase I study include a partial response in a 4th-line head and neck cancer patient who had progressed on prior PD-1 therapy. Since tagmokitug added to toripalimab rescued the prior PD-1 failed response, this exciting data demonstrated that CCR8 positive Tregs were a primary mechanism of resistance.

Our ongoing expansion cohort in head and neck cancer is to design to answer if CCR8 positive Tregs are a primary PD-1 resistance mechanism in this second-line patient population. The other approach we are investigating for T-cell activation following tagmokitug treatment is the direct activation of the T-cell receptor complex by simulating a protein called CD3. This allows for the activation of naive T-cells. Many T-cell engagers or TCEs are bispecific antibodies that bind a tumor protein on one end and CD3 on T-cells on the other end. TCEs lead to redirected T-cell killing of the tumor and have success in hematological malignancies, but limited success so far in solid tumors. Data support there are two main issues in solid tumors leading to modest TCE activity.

A low density of T-cells in the tumors for the molecule to bind both the tumor and the T-cell in close proximity, secondly, Tregs presence and also activation leading to suppressing T-cell response. We are pleased to have announced the agreement with Johnson & Johnson to study the combination of tagmokitug, a Treg depleting antibody, with pasritamig, a prostate-specific TCE binding to KLK2 on prostate tumors.

With the advancement of this combination study, tagmokitug becomes the first CCR8 antibody in prostate cancer and the first CCR8 antibody in combination with a TCE. Coherus Oncology continues to lead the science for the CCR8 class of drugs. As I indicated earlier, Tregs are known to limit cancer therapy, tagmokitug has now shown it is a targeted therapeutic approach to deplete Tregs and change the immune balance by increasing T-cells in tumors.

Importantly, all immune activating agents, immune checkpoint inhibitors like PD-1 inhibitors and TCEs, increase the number of Tregs in tumors, as do most anti-cancer treatments. For example, a recently published study showed that androgen deprivation therapy increases Tregs in prostate cancer, there is a number of scientific reports showing that radiation, chemotherapy, targeted therapies, angiogenesis inhibitors also increase Tregs in tumors, and this associates with worse outcomes for patients. We believe that there is broad potential for tagmokitug to be used in combination with other therapies as a cancer treatment, and we are excited that pasritamig/tagmokitug combination is the first with a partner company. Of course, we continue to explore novel combinations with other partners. With that, I will turn it over to Dr. Dias, who will further describe the clinical development. Rosh?

Thank you, Theresa. Good afternoon, everyone. I'm pleased with the continued progress of our multi-regional clinical development program for both tagmokitug and Casdozokitug. Programs for both molecules address areas of clear unmet medical need in very intentionally designed clinical studies, which are supported by strong scientific and clinical rationale. We remain on track for initial data readouts from mid-2026 onwards, as we've previously communicated. Let me now take a few minutes to highlight each program individually. Firstly, tagmokitug, our highly selective CCR8 cytolytic antibody, for which we're currently running two protocols in what we've named our Treg Check program.

The first protocol, in a second-line head and neck squamous cell population, builds upon the exciting data we presented at AACR 2025, where we showed data demonstrating clear tumor remodeling with Tagmo monotherapy, with depletion of CCR8-positive Tregs, accompanied by a profound increase in the CD8 positive T-cells, consistent with a much more cytotoxic tumor microenvironment.

As you've just heard, combinations facilitate activation of these ingressed T-cells. In the same study, when Toripalimab was added, we showed a partial response in a fourth-line head and neck squamous cell patient refractory to prior PD-1 therapy. Our current head and neck squamous cell approach looks at 40 patients in two doses of Tagmo in combination with Tori and asks the question as to whether Tagmo is able to reverse PD-L1 resistance in the second-line population. We continue to anticipate initial data midyear 2026.

Our second protocol is an umbrella protocol with four targeted tumor types in cohorts A-D, including second-line upper GI adenocarcinoma, second-line ESCC, first-line ESCC, and fourth-line plus colorectal carcinoma, respectively. The upper GI adeno cohort is a second-line cohort, including gastric adeno, GEJ, and esophageal adenocarcinoma, also broadly asking the question of whether Tagmo is able to reverse PD-L1 resistance. As a reminder, this is a tumor type that has shown proof of principle of the class, with Lenova Medicine showing data for their CCR8 in combination with our PD-1 inhibitor, Tori, at ASCO 2024, with an encouraging overall response rate in a second-line plus gastric population. Our upper GI adeno cohort looks at two doses of Tagmo in combination with Tori in 40 subjects. Again, we continue to anticipate early data around the middle of this year.

Our esophageal squamous cell cohorts take advantage of the activity of Tori irrespective of PD-L1 levels, which is perhaps most marked in this tumor type and which forms the basis of Tori's approval as the only EU-approved PD-1 for esophageal squamous cell irrespective of PD-L1 status. Cohort B is a second-line esophageal cohort with two doses of Tagmo in combination with Tori. Cohort C looks at first-line esophageal population with Tagmo in combination with both Tori and chemo, with the explicit intention of developing safety data in combination with chemo, which could allow us to explore earlier treatment paradigms.

We anticipate data in the second half of this year for these two cohorts. Cohort D looks at Tagmo in combination with Tori in the fourth-line plus colorectal carcinoma population, an area which constitutes an increasing public health issue, particularly in younger age groups.

As a reminder, the CCR8 field has shown some responses in CRC, our approach looks at 20 patients with an initial focus on the non-liver-met population before moving on to advance into the liver-met population. We started the CRC cohort in the second half of last year, we anticipate early data late this year or perhaps even early 2027. We're very excited to start the tagmokitug pasritamig combination cohort, which, as you heard from Theresa, represents both the first TCE CCR8 combination study as well as the first in CRPC and is a very rational combination based on the mechanism of action of both agents. This combination aims to build upon the pasritamig data shown at ASCO 2025, demonstrating an encouraging PSA50 in a late-line metastatic castration-resistant prostate cancer population, supporting advancement into pivotal studies.

Metastatic CRPC is considered an immunologically cold tumor and has limited treatment options once patients get to later lines of therapy. Our initial approach will be in a third-line plus population, looking at a safety cohort and additional PSA50 endpoints, which we anticipate starting in the second half of this year. Moving on now to Casdozokitug, our first-in-class antibody targeting IL-27, a context-dependent immunosuppressive cytokine, particularly relevant in tumors such as Hepatocellular Carcinoma and non-small cell lung cancer.

Our recently named Catalyze program focuses initially in first-line HCC and builds upon the very encouraging data presented at ASCO GI 2025, where we demonstrated that the addition of Casdozo to the current standard of care, Atezo and Bev, provided a 38% overall response rate and, perhaps more importantly, a complete response rate of 17%, both of which compare very favorably to historical benchmarks with activity irrespective of etiology and a strong durability of response with a favorable safety profile.

Our current ongoing study swaps out Atezo for our PD-1 Tori and includes 72 patients in three arms. That is two dose levels of Casdozo in combination with Tori Bev versus Tori Bev alone and is designed with three aims. Firstly, to further characterize efficacy and safety, as well as address FDA's Project Optimus and address contribution of components as we move through the development pathway.

This trial continues to accrue well globally, and we remain on track for initial data around mid-year 2026. As a reminder, the previous study demonstrated an increase in response rate and a deepening of response with time, and so we do anticipate the same with the ongoing program. In summary, our Treg Check program with Tagmo in several targeted cohorts is intended to inform us in which of these specific tumor types we may see a signal to take forward into broader programs.

Our Catalyze program with Casdozokitug is asking the question of whether we can improve on the current standard of care with the addition of Casdozokitug. The two key determinants of exact timing of data availability are firstly, the numbers of patients accrued to study, and secondly, the numbers of scans that may be required to show activity, which will differ by program.

We remain on track to show initial data mid-year 2026 and beyond, we'll continue to provide updates on progress. With that, I'll hand it over to Sameer. Sameer?

Thank you, Rosh. We're happy to report that LOQTORZI net revenue grew to $40.8 million for full year 2025, versus $19.1 million in 2024, representing 113% growth year-over-year. As we have stated previously, going forward, we expect average quarter-over-quarter demand growth of 10%-15%. Similar to 2025, we will see some variability in individual quarters due to patient flow and other factors. For Q4, net revenue was $12.4 million and 11% growth over Q3. We saw strong quarter-over-quarter demand growth of 15.5% in Q4. The delta between net revenue and demand growth was driven by wholesaler inventory declines in Q4 versus Q3.

Demand growth was driven by new patient starts in both new and existing accounts, and we saw an 11% increase in purchasing accounts, indicating continued increase in breadth of use. While we're happy with that 2025 growth, there remains significant opportunity, especially in the community segment, where use of chemo only and off-label IO persists. As you'll recall, the NCCN guidelines for NPC were updated late in 2024, placing LOQTORZI as the only preferred treatment for recurrent and metastatic NPC.

These guidelines served as a stimulus for LOQTORZI growth in 2025, and we remain focused on driving education on the guidelines and our superior overall survival versus chemotherapy alone. That brings me to the exciting and game-changing six-year long-term overall survival data that was presented at ESMO Asia in December. This new data shows that patients on LOQTORZI plus chemo live for almost 65 months or over five years.

In contrast, chemo-only patients live for less than three years. That is a 2.5 years of additional survival benefit for LOQTORZI patients. With this data, we believe that no patient should be receiving chemo alone for NPC, a belief that is shared by a vast majority of KOLs. Our primary focus is thus on educating all target oncologists on this new survival data. We're pulling all stops to get this game-changing data in front of physicians. Our sales team has been fully trained and is focused on educating physicians as we speak. On the multi-channel side, we're taking a multi-pronged approach with several tactics, including KOL educational videos, short messages, and emails that are being delivered to target physicians. We're also making significant investments into CRM technology platforms and data enhancements to raise our rare disease execution using advanced analytics.

We have doubled our investment to purchase additional claims data and patient alerts data. This provides us visibility into almost 70% of all U.S. claims, which are then used to alert our sales team on real-time patient opportunities. We have expanded our field footprint to reach more physicians. While our field team focuses on tier one or high-value targets, NPC being a rare disease, patients can present at any oncology office across the country. We are thus expanding our reach by activating a remote sales team that will reach tier two physicians while the field team focuses on tier one targets. There's also a sizable NPC opportunity in the Veterans Affairs hospitals. The VA hospitals are typically hard to access. We've engaged a specialized team of contract representatives, all of whom have extensive experience selling in the VA.

In summary, we remain confident in meeting our goal of achieving a dominant share in the NPC market with peak share expected in 2028. With the profound survival advantage that we see in the six-year long-term data, our entire commercial organization remains committed to ensuring that no patient misses the opportunity to live longer with LOQTORZI. With that, I'll now pass the call to Bryan McMichael, our Chief Financial Officer.

Thank you, Sameer, good afternoon, everyone. I'll start with a review of the company's financial position at the end of the year and results for Q4. I will provide additional insights into how our balance sheet has evolved and some forward-looking color. As mentioned by Denny, over 2024 and 2025, we decreased the principal balance of our term and convertible debt by over 90% from a high of $480 million-$38.8 million at year-end 2025. This resulted in a significant reduction of interest costs, which I will cover later. This also extended our earliest debt maturity to May 2029. Headcount decreased from about 228 at the end of 2024 to about 147 at the end of 2025, an approximate 35% reduction.

Some of the most significant changes for Q4 include the reduction of legacy liabilities associated with the divested businesses. Specifically, accrued rebates, fees, and reserves, which comprise mostly legacy product liabilities, total $30 million at December 31st. This is less than half of the $67 million balance one quarter earlier. The transition of commercial contracts to a court was mostly complete at the beginning of Q4. This initiated the wind down of TSA assets and liabilities. Substantially all of the TSA receivables were collected in Q4, bringing the balance from $241 million at the start of the quarter to less than $1 million at year-end. The cash collected has been used to reduce TSA liabilities from $254 million at the start of Q4 to $65 million at year-end.

We expect the remainder of the, these legacy business liabilities to be paid down in the coming quarters in a front-weighted fashion. In addition, let me remind you that we are eligible to receive two earn-out sales milestones of $37.5 million each. The criteria to earn these milestones is based on four consecutive quarters of UDENYCA sales starting in Q3, 2025. $300 million within five quarters or through Q3, 2026 for the first $37.5 million milestone, and $350 million within seven quarters or through Q1, 2027 for the second milestone. With two quarters of sales relative to the earn-out term behind us, we believe we are favorably positioned to earn these payments and will re-keep you updated.

Sameer covered in detail LOQTORZI net revenues year-over-year growth and the additional investments in commercial infrastructure to expand sales that we are making. We expect to provide full year 2026 revenue guidance on our earnings call in August. Let me now turn to OpEx. With Q4 falling largely in line with the trends we saw throughout 2025. Specifically, SG&A expenses from continuing operations decreased to $23.6 million, down from $29.6 million in Q4 last year. It's important to note that this represents the fourth consecutive quarter that these expenses were flat or down as we completed the transformation of the business. The decreases are primarily due to reduced head count, exiting biosimilars, and spending discipline. R&D expenses from continuing operations in Q4 were $31 million as compared to $20.8 million in Q4 2024.

In contrast to SG&A, R&D expenses slightly increased every quarter in 2025 as we invested in Coherus's promising pipeline. Of course, reduction of debt has resulted in significant reduction in cash paid for interest. This relates to borrowings reflected in both continuing and discontinued operations, and was $9.9 million in 2025. This reflects a savings of greater than $15 million over the $25.4 million paid in 2024 and underscores the benefit from the paydowns of debt in 2024 and 2025. We had cash equivalents, and investments of $172.1 million at year-end. As you know, we recently raised capital, including a $50 million follow-on offering last month. Use of these funds include, first, investments to support the significant upside potential of the pipeline.

This includes additional indications of tagmokitug as Treg depletion has emerged as a very important MOA in cancer therapy. Recent examples include our phase II-A CRC study, as well as the anticipated start of the combination study with J&J in metastatic prostate cancer. We are making additional investments in our commercial footprint and capabilities to pursue the $250 million commercial opportunity presented in LOQTORZI and NPC, as covered by Sameer. He discussed how our growing LOQTORZI sales will cover more and more costs in the coming years. To add some color, at the point that our commercial effort is paying for itself, we mean that LOQTORZI sales will cover costs, royalties, and cash costs of the sales force.

When revenues cover c-core burn, we're referring to the commercial, these commercial efforts plus other cash costs other than those directly related to clinical trials. With that, I will hand the call back over to Denny.

Thank you, Brian. We're pleased with our progress in 2025, having doubled LOQTORZI sales while completing the transformation from biosimilar company to an innovative oncology company focused on overcoming immune resistance in cancer. We are particularly pleased that at the same time, we're able to reduce overall debt by over 90% since its peak in 2024 to just $38.8 million at the end of 2025. We are now strategically well-positioned with growing revenues from our foundational PD-1 inhibitor, deal opportunities across the portfolio and geographies, and two promising pipeline candidates with multiple 2026 clinical readouts. Operator, we're ready to take the questions.

Thank you. As a reminder, if you wish to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. We will take our first question. The first question comes from the line of Jay Olson from Oppenheimer. Please go ahead. Your line is open.

Hey, guys. Congrats on the progress, thank you for taking the questions. We had a couple of questions on LOQTORZI. Can you please provide some more color on the dynamic between new patient starts and repeat patients in 2025, then how you anticipate that balance to shift throughout the course of 2026? Also, if you could talk about the promotional sensitivity of LOQTORZI and any details in the sort of commercial infrastructure investments that you're planning to make this year, such as increased field force. Then I had a follow-up on tagmo, if I could.

Thank you. Thank you for your question, Jay. I'll let Sameer address the issue on the new versus repeat patients and then move on. Go ahead, Sameer.

Yeah. Thank you for the question, Jay. Regarding new versus existing patients, in 2025, approximately 25% of our business came from new patients, and the rest came from continuing patients. As you mentioned, what does that look like in the future? I think that mix will shift slightly more towards new patients because we have a lot of opportunity to grow in the new patients. The existing patients will always remain a strong base of our business because over time, we expect the duration of therapy to keep increasing as well.

Okay. Sameer, can you address Jay's question regarding the.

Yeah.

sensitivity of the product?

Sure. Regarding promotional sensitivity, LOQTORZI is extremely promotion sensitive, because our challenge is that physicians in the community, they usually see 10-15 different cancer types, and they don't see LOQTORZI, they see maybe one or two NPC patients in a given year. They have to be continuously reminded about LOQTORZI and the benefits of LOQTORZI. I'll say this, when we do promote LOQTORZI to a physician, when we present the efficacy data, almost always we get complete buy-in about using LOQTORZI for the appropriate patients. Again, highly promotion sensitive, and we see a lot of opportunity to drive further growth. Does that answer your question, Jay?

Yeah. I guess maybe just any details you could provide on the additional investments in commercial infrastructure. Would that include field force expansion?

Yeah. We did do a modest field force expansion about a quarter ago that we announced. We did a 15% expansion in the live sales force. Now we're adding about four inside sales representatives to expand our reach into tier two targets. As I mentioned in my prepared remarks, we're also adding a VA-targeted contract sales force to focus on the Veterans Affairs business. That's the expansion we've done in a very targeted and focused manner.

The other area of investments, Jay, is our information technology infrastructure. Because this is a rare disease, we feel that we need to make all efforts to capture as many of the patients as we can. Last year, we captured about 30%-35% of the diagnosis code alerts. This year, we've expanded that to about 65%-70%. We have also made investments in our display technology for the dashboards for the sales team. Further, as Sameer just alluded to, we have the inside sales force, which is also organizing and pursuing these alerts.

Great. Thank you.

I would just, yeah. I would just make one closing remark. We believe all these are appropriate in the context of driving to the potential $175 million annualized sales per year, which we think is important for us to do as soon as possible.

Super helpful. Thank you for those details.

Thank you, Jay.

If I could ask one more question on Tagmo, can you just talk about any plans for exploring a triple combination? I know J&J just reported phase I combo data for pasritamig and docetaxel. How are you thinking about adding Tagmo into that for a triple combo in prostate cancer?

Dr. LaVallee?

Yeah, no, I think that maximizing patient benefit in CRPC is what we're looking for. Clearly watching the results of those studies. I think we'll take the first step, which is the prudent step of putting the two drugs together to see what the contribution of effect is, the safety, the efficacy, and then if it's possible to move up into earlier lines through other combinations that would be of interest.

Great. Thank you so much for taking all the questions.

Sure. Thank you.

Thank you. Your next question comes from the line of Mike Nedelcovych from TD Cowen. Please go ahead. Your line is open.

Hi. Thanks for the questions. I have two. My first is on Kendozo/Keytruda. I believe the frontline HCC trial is randomized but not blinded, so I'm curious if you're tracking responses, and if so, is what you're seeing giving you more or less confidence in Kesdozo's outlook? That's my first question. My second question relates to Tagmo/Keytruda. You have a wealth of data coming mid this year in various tumor types, so I'm just curious how you're planning to disclose those data. Will we get press releases, kind of indication by indication, one lump release of data across a solid tumor trial? How do you plan to disclose this data? Thank you.

Thanks, Mike. I'll let Dr. Dias take those two questions for you. Rosh, would you like to answer the Casdozokitug trial and then the tagmokitug data questions?

Hi, Mike. Thanks for the question. In response to your first question on Casdozokitug, obviously these are ongoing trials. These are open labels, but obviously because they are ongoing trials, we will report them when they are mature. What I will remind you is that for the previous atezo-bev Casdozokitug study. You know, I outlined the top line results in my prepared remarks. We did see a maturation of data with time in terms of an increase in response rate and a deepening of the response. Again, Casdozokitug, ongoing study, no further comments at this stage on that. In terms of the tagmokitug question, your question is essentially how will we be reporting them?

You know, again, as I said in my prepared remarks, there are really two determinants of data availability, the number of patients and then the numbers of scans. These will differ by the different tumor types and the different programs. What that essentially means is that it's not easy to predict the exact timing, right? Fundamentally, there are two scenarios. Either the timing aligns to the submission deadlines for a congress or it doesn't. If it's the former, we will release it at a congress. If it doesn't, we will essentially release by corporate disclosure. I'll just remind you that we do have a, like, a track record of releasing data as it becomes available. I'll refer you to, you know, the AACR data last year. That would be our kind of high-level plan.

Great. Thank you so much.

Thanks.

Thank you.

Thanks.

Your next question comes from the line of Colleen Kusy from Baird. Please go ahead. Your line is open.

Hi. Good afternoon. Congrats on all the progress. Thanks for taking our questions. Maybe a follow-up on the, Casdozokitug frontline HCC study to start. Understanding those data will continue to mature over time, but can you give us a sense of, you know, what you think that maturation timeline is, and how many of those patients that you'll report in this initial, readout will be in that, you know, mature window? Is there a bar at this kinda early readout that you'd be hoping to set?

Yeah. Let me unpack that a little bit. Your first question, in terms of, you know, in terms of what we will be expecting, you know, what we'd want to do is, really, you know, have an overall response rate over what we saw, you know, previously in terms of the current standard of care. I'll remind you, that was around 30% for the atezo-bev alone combination. The maturation time period for our previous study was somewhere between six-12 months, right? There were several different data cuts, and over those three data cuts, over that kind of, you know, six, nine, 12-month period, there was an increase in response rate and a deepening of the response. That's really, again, what we would expect.

In terms of the numbers of patients, and what data we will be likely to report, that's a bit of a tough one to comment on exactly, primarily because of what I said in my prepared remarks, right? There are two determinants. It's how patients are accrued, but also the numbers of scans that were reported out. We will continue to report that out as we as we know. What I will say is that, you know, I think we'll have enough patients with enough scans to, you know, give an indication of early activity around mid-year timeframe as we've communicated previously.

Great. That's helpful. Thank you. If you could just kind of walk us through what you're viewing as some of the important updates on the competitive front for CCR8 this year and how that might impact your development strategy going forward?

Oh, thanks for the question, Colleen. We'll let Dr. LaVallee address that. Therese, any comments on the competitive dynamic in the CCR8 space?

Yeah. I mean, I think we expect to see the bookends of more data disclosures would be the positive and seeing updates from the programs, particularly from some of the big players that have upwards close to 1,000 patients on their study. We would anticipate, I mean, what I'll note for BMS is that they, in the last two J.P. Morgans, have had CCR8 on their launch map by the end of the decade. We may see other programs being parked because of m-molecule issues.

Colleen, just one additional point I wanted to also mention in terms of data availability. Obviously, you know, I've said this before and I'll repeat it, we are not just looking at ORR alone. you know, durability is important, safety is important, and, you know, overall clinical benefit rate is important. It's that really that kind of totality of data that we'll be looking at as we move through the program.

Thank-

Great.

Thank you, Colleen.

Last one, if I can, just, congrats again on the recent J&J deal. Just thinking about what for the next BD deals, what you might find most attractive for tagmo. Would you stay within the T-cell engagers or what would be most appealing to you there? Thank you.

Well, as we mentioned in our prepared remarks, one of the very interesting things that's so promising about tagmokitug is the potentially broad application of the mechanisms of action across modalities, whether it be ADCs, T-cell engagers, radiation. As Dr. LaVallee indicated in her prepared remarks, a lot of cancer therapies result in greater Treg generation. We think it's very broad and we, I think we'll focus on doing additional arrangements with other parties and, you know, see what we can get done so far this year.

Great. Thanks for taking the questions.

Thank you, Colleen.

Thank you. We will take our next question. The question comes from the line of Brian Cheng from J.P. Morgan. Please go ahead. Your line is open.

Hey, guys. Thanks for taking our questions this afternoon. Just for Tagmo, how should we think about the strategy to develop your prostate cancer combo here with Pasri, in terms of the priority, given your hands is currently in multiple indications today?

Yeah, I think all the studies are executable. I mean, I think really getting the data across the tumor types that have a strong scientific rationale for a high degree of target expression with different immune contexts is our priority. I mean, given the prevalence and the need in CRPC, I mean, those studies should enroll relatively quickly. It could be a very exciting indication to look at. It's equally important to all the other ones. We're really looking for the data to learn. As Rosh and I have talked about in the past, our program is very intentional to learn the best context for how to use tagmokitug, and now not just with toripalimab, but also with the T-cell engager.

As you think about the bar for, you know, mCRPC here, what would you want to see in this third line plus setting, in terms of PSA50 endpoint?

I mean, a couple of points I'll say. You know, as I said in my prepared remarks, we'll be looking at safety as well as PSA50, so both will be important. I won't comment too much on expectations at this stage, but what I will say is if you look at the current, the current treatment environment for PSA50, you know, it really goes. It drops dramatically after the second line, right? First line, you know, can go up to about it's around 70% or up to 70% in terms of PSA50. When you get to second line, it's in the 45% range. When you get to third line, it's, you know, around the 20% or less stage. Those are really kind of the current benchmarks.

Further than that, I won't comment until we, you know, start opening up the study, which we anticipate to be in the second half of this year.

Brian, I think, you know, this is Denny. I think you can look forward to having a little more comment on this study, on the August call, which we'll report Q2, given the fact that we anticipate initiating it in the second half of the year.

All right. Well, thank you so much for your, for your color. Thanks.

Thanks, Brian.

Thank you. Once again, if you wish to ask a question, please press star one one on your telephone. Your next question comes from the line of Douglas Tsao from H.C. Wainwright. Please go ahead. Your line is open.

Hi. Good afternoon. Thanks for taking the questions. Danny, I think it was, you know, you said that around $35 million, you know, the revenue level, you know, you sort of basically become sort of cash flow breakeven, excluding R&D. I guess how, you made a comment sort of that R&D was discretionary or sort of you had a, not discretionary, but you sort of had sort of ability to make choices where you're spending the money and how much.

I guess maybe if you could just help us with the framework in terms of what you think is an appropriate level of R&D spend, and how do you find that balance between sort of the revenues that you're bringing in versus maybe needing some additional outside capital to fund the R&D program, just given the fact that the aperture of opportunities for the company seems to have been expanding quite nicely. Thank you.

Thanks, Doug. Let me try to frame our view and provide you a lens through which to view the budgetary considerations. You know, firstly, as I indicated, with the commercial team, the commercial spend includes the commercial team itself, all the commercial spends, the computer systems, the IT spends, whatever the sales force needs. Also royalties, for example, there's a 20% royalty to Junshi. There's COGS. I characterize all that as sort of the spend to get the sales. That is probably $15 million, $16 million-ish a quarter.

Regarding the other spends, you know, the $30 million-$35 million, that includes carrying also those same commercial spends, you know, with the increased COGS because of, you know, increased sales. Also, you know, the internal SG&A, the rest of the headcount in the company and so on. In fact, everything except what I would characterize as additional development or clinical trial costs. Those we view in a separate bucket, and I would put those in bucket number three. When we initiated the development of the assets post the Biosimilar spin out, you know, we had $250 million, and we were moving forward, and we identified a series of trials that we wanted to do. What we had done since then, of course, we did expand that a bit.

We, you know, we feel that it's very strategically worthwhile to pursue the engagement with J&J with prostate. We also think that CRC is an area of unmet medical need. For the time being, we feel we're clearly funded for the clinical trials that we've done. As tagmokitug, as Dr. LaVallee, you know, recited to you, has very broad potential applicability. On the other hand, I think that we've shown ourselves to be very judicious and thoughtful with our spends, and we'll continue to do so. You know, we want to understand the mechanism of action. We want to understand really where it works and why it works and place our bets there. I think that overall, we've positioned the company well for the future.

As you've known us a long time, we keep a pretty sharp eye on our finances. Lastly, I think that our track record with LOQTORZI over the past couple of years, particularly the doubling of revenues, you know, 2025 over 2024, you know, gives us a fair degree of confidence that we'll be able to march it up to $175 million, as annualized, sales in 2028. As I pointed out, you know, signposts along the way are some $15 million or $16 million where the commercial team pays for itself and then on to, you know, $30-plus where we carry the rest of the company. That's the fundamental role of LOQTORZI really, is to pay for all those things for us so we can develop the drugs. That's the lens through which we view it.

Okay. Okay, Denny, that's really helpful. Just maybe a follow-up for Sameer. Just what is the current duration of therapy for patients on LOQTORZI right now? I mean, I think you sort of indicated, that you expected to see an increase in the number of new patients start. I'm just curious how much of an opportunity is there for you to see an improvement on the persistence equation?

Yeah. Thanks for the question. Just to remind you, there's two types of indications we have. We've got a frontline indication in a locally advanced recurrent setting and the frontline metastatic. We also have the second line metastatic and third line metastatic indications. The duration of therapy in the second line indication should be much shorter than the frontline indication. That's kind of the basic assumption from the clinical trials. That being said, we look at the duration of therapy every three months looking at claims data. The duration of therapy continues to grow every time we look at it. I'm still not ready to give you a number on the average duration of therapy because we simply don't have enough patients and cohorts to look at an average number.

What I can say is the duration continues to increase, and we still have room to grow from where we are today to where the clinical trial duration was. To answer the other implied question you had, the contribution from the existing patients and the contribution from new patients will continue to both grow as we go through the next couple of years.

Okay, great. Thank you.

Thanks.

Thank you, Doug.

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